psychological wellbeing practitioner personal statement example

Cookies help us to give you the best experience on our website. You can change your cookie settings if you wish. Otherwise we'll assume you're OK to continue. OK See our policy

May 28, 2021, by indybamra1

How I Applied to IAPT Training

By, Kat Wheatley, BSc Psychology and Cognitive Neuroscience graduate (2020)

IAPT… PWP… What does it all mean?!

Improving Access to Psychological Therapies (IAPT) is an NHS initiative that helps people with common mental health difficulties access talking therapies. If you’re planning to start a career in IAPT, chances are you will be applying for a role as a trainee Psychological Wellbeing Practitioner (PWP), like myself.

As a PWP I support adults with mild to moderate anxiety disorders and depression, by providing low-intensity interventions that are based on principles of cognitive-behavioural-therapy (CBT). I also conduct assessments, manage risk, and work alongside high-intensity (HI) therapists and other clinicians, in addition to liaising with GPs and other agencies.

Is IAPT right for you?

PWP work is hard! So it’s important to know what you’re getting into. I regularly work with patients who are distressed, at a high risk of ending their life, and who have experienced crippling traumas and abuse. And while we strive to maintain a patient-centred approach, this is a constant battle in target-driven services, such as IAPT. I often finish the day exhausted and occasionally upset, and after a long working day, I still need to muster up the energy for my academic assignments.

With all that said, I love my role as a PWP, and I would not change it for the world. I get to help people improve their lives by working alongside the most supportive and enthusiastic colleagues I have ever met, all the while being paid to get a qualification! There are also great opportunities to progress in areas like supervision, management, or further training as a HI therapist or clinical psychologist.

Experience is key

To be successful in your application you will need to demonstrate you have the insight, organisation skills, and emotional resilience to meet the demands of IAPT work. That is why experience in mental health is key! When I applied for this role, my CV included volunteering for Nightline, disability care, and a placement year with Child and Adolescent Mental Health Services . I also related to skills I developed as a rock-climbing coach to help me stand out from the crowd.

If you’re concerned about your current experience, remember it’s never too late to start. Quality is more important than quantity!

So how do I apply?

Paid vacancies can be found on the NHS Jobs website, Indeed , and sometimes directly through a university. Often these close quickly (some in as little as eight hours), so I would recommend searching regularly.

Alternatively, a list of accredited self-funded courses can be found on The British Psychological Society website.

Personal Statements:

This is your opportunity to demonstrate exactly how you meet their criteria, regarding your education, experience, and personal skills. Employers have hundreds of applications to sift through so keep it clear and concise – I would recommend using the same sub-headings as the job advertisement. Finally, I would steer clear of mentioning your aspirations for further training as this will likely work against you.

Typically, there will be a panel of 2-3 interviewers including a PWP, team lead, and an academic staff member. Be sure to provide examples to support your answers and consider using the STAR / CARL models to help you structure your response. Remember, they want you to do your best, so take a deep breath and let your personality shine through! Below are some common questions I was asked and my Top Tips (TT) to help you prepare:

Q: “What is your biggest strength/weakness?” TT: Honesty is key – demonstrate insight into how this may affect you in the role.

Q: “Why do you want to be a PWP / what are your future plans?” TT: Demonstrate your interest in PWP work. It’s ok to have career aspirations beyond Step 2, but services don’t want to pay for your training only for you to leave for further training.

How the UoN Careers team can help you

Out of 50 applications, I was only offered two interviews and it is not uncommon to be unsuccessful in the first-time round. However, you can maximise your chances by speaking with the UoN careers advisers. Here are just some of the ways they can help:

Finding suitable work experience / vacancies
Adapting your personal statement to give you the best chance of selection
Practicing interview skills.

I do not think I would have secured my role without their support, so I urge anyone considering a career in IAPT to do the same. If you need support it would be a good idea to book an appointment with a careers adviser.

Share on Facebook
Share on Twitter
Share on Google+
Share on LinkedIn

No comments yet, fill out a comment to be the first

Subscribe by email

Careers and Employability Service
Graduate jobs
Career paths
Work experience and volunteering
Making applications
International students
Careers events

Find, follow, join us

Become an affiliate partner and earn attractive commission.

Counselling & Psychology

Trainee Psychological Wellbeing Practitioner Interview Questions and Answers

Lead Academy

A psychological well-being practitioner career is gratifying, established and diversified. This blog provides a thorough overview of the trainee psychological wellbeing practitioner interview questions & answers.

Table of Content

What is a Psychological Wellbeing Practitioner?

How to become a pwp, how long do pwp courses and training take, how is a pwp interview conducted, tips to outshine in pwp interview, top 21 trainee psychological wellbeing practitioner interview questions & answers, what are the skills of a pwp trainee, what is cbt, how much does a pwp make, what to read next:.

First of all, we need to know the definition of a psychological well-being practitioner.

According to the NHS , “ Psychological Wellbeing Practitioners (PWP) are the trained professionals who support and assist people with recurrent mental health problems such as depression and anxiety disorders.

They guide the victims by showing them how to facilitate their self-recovery”.

To know about PWP in detail, we further need to know about a few more topics. These are:-

Stepped Care Model.

PWP is an integrated part of the IAPT system. Now, what is the IAPT system?. As claimed by the NHS , to treat the depression and anxiety disorders of England, in 2008, the government began the globally recognised program known as the Access to Psychological Therapies (IAPT).

Stepped Care Model

The PWP role rests in the 2nd step of the mental health stepped care model . This stepped model is designed to provide mental support based on the requirements of the people. It means that physiological wellbeing practitioners are the mental health workers who focus on primary mental issues such as mild depression, mild anxiety, panic disorders etc.

Before moving on to know about the trainee psychological well-being practitioner question & answers, let’s learn about the background of becoming a PWP.

Stages of a PWP

According to Psychological Professions Network (PPN), a psychological wellbeing practitioner is classified into three stages. These stages are:

These candidates might or might not have any previous degree in psychology, but they must comprehend academic studies.

Those who fall under this category must have a BPS accredited qualification in Primary Care Mental Health Practice or equivalent Qualified Graduate Primary Mental Health Worker Qualification (2004-2008). In addition, they must have demonstrable skills in providing step 2 IAPT clinical service.

These candidates must have the qualification mentioned above as the qualified PWPs’. Furthermore, they must demonstrate the skills to drive forward and develop the step 2 workforce.

Anybody can train to become a PWP. But they need to have excellent interpersonal skills and eagerness to work with people with mental health problems. The ideal candidates for this role are:-

A non-graduate.
A psychology graduate.
Graduates from other fields.
Any mental health professionals.

Psychology and Counselling Courses Online Mega Bundle

Accredited Courses
Tutor Support Included
3 Installment Plan at checkout
14 Days Money Back Guarantee

What are the ways of becoming a Psychology Wellbeing Professional?

There are many ways by which a person can grind in the dream of becoming a PWP. There are various ways, and mostly these are:

Apprenticeships.
University Programs.
Online courses.
Training Programs.

Apprenticeship

Apprenticeship is a fantastic opportunity for non-graduates who are passionate about helping people who are struggling mentally every day. They must have any of the following achievements: academic qualification of level 6, Functional Skills Level 2 or a GCSE certificate with grade C (Maths and English included).

University programs

Many accredited universities provide various relevant courses under multiple titles. These courses aim to give the students an overview of IAPT. Moreover, there are many courses solely focused on PWP.

Online courses

Many renowned online course providers offer various accredited courses. These courses prepare a person with the necessary skills to become a successful PWP.

Moreover, many of these courses cover trainee psychological wellbeing practitioner interview questions & answers that can help a person cross the hurdles while being interviewed for a PWP position.

Training programs

Several training programs accredited by the British Psychology Society (BPS) train to become a PWP. To access this training, a person needs to apply for a trainee position in an IAPT service.

The time duration of the PWP courses varies depending on whether you are taking a university course or an online course, or accredited training. But generally, PWP academic duration is one year, and the accredited training duration is 45 days.

A PWP position is not easy, so the recruitment process is quite rigorous. This process might vary across organisations, but generally, it is divided into four stages, and These are:-

Presentation

Panel interview.

The variety and difficulty level of trainee psychological wellbeing practitioner interview questions & answers will vary across these stages.

Cartoonish representation of two boys acting doctor and patient.

During this stage, two candidates will be paired up as a team. One candidate will be tasked to act as a patient, and the other will have to do the mental health assessment of the candidate posing as a patient. Two interviewers will overview this stage.

This nerve-wracking stage will help the interviewers determine a candidate’s ability to identify and intervene in a psychological condition. Furthermore, this will display his interpersonal skills and the ability to work as a team player.

Cartoonish representation of a group session taking place among some people

In this stage of the PWP interview, candidates will be equally divided into two groups to debate the pros and cons of a given topic.

This debate session will help the interviewers identify their communication and teamwork skills.

Young man delivering a speech in front of a group of youngsters.

PWP candidates might be asked to give a 5-minute PowerPoint presentation about specific mental health topics during the interview day.

Suit-clad man giving a blank piece of paper and a pen to the person seated in front of him.

Top Courses of this Category

Psychology Course for Narcissistic Personality (NPD) Disorder

Drug and Alcohol Worker Course Online

Psychology Masterclass Course Online: Learn Behavioural Psychology

Psychology, Counselling, Psychotherapy & Anxiety – 4 Courses Bundle

Advanced Diploma in Psychology Course

Panel Interview is one of the most challenging stages of the entire interview process because this stage will solely focus on trainee psychological wellbeing practitioner interview questions & answers. In addition, the candidates will be asked about various conceptual topics such as IAPT, Stepped care model etc.

Moreover, they can be asked multiple questions regarding their life and various personal experiences.

"Success - go get it -" written as white-coloured text on a black background.

It’s not rocket science to do well in a PWP interview. However, there are quite several tips and tricks that might give you just the edge that you need to do well in a PWP interview.

These magical tips and tricks are as follows:

Don’t Panic:

The first and foremost tip is to remain calm and confident as much as possible. No matter how intimidating your interviewer might seem, a calm and confident outlook will radiate positive vibes to your interviewer.

Strong basics:

Keep your knowledge about the basic concepts and definitions solid. Most of the trainee psychological wellbeing practitioner interview questions & answers based on conceptual theories are about psychology, essential acronyms like IATP, PWP etc. So, practising them the night before will help you answer most PWP interview questions.

Look Sharp:

Keep your outfit as clean and formal as possible, and try to follow the basic etiquette of an interview.

These tips will surely help you stand out amongst the other candidates and perform exceptionally well in the interview.

Develop Your Team to Lead The Industry

Get fully accredited thousands of high quality online courses taught by the world’s leading experts suitable to companies of all sizes.

Here is a top 21 list of the most regularly asked PWP interview questions. Practising them will ensure more volume to your preparation. These questions are suitable for qualified PWP interview questions,

senior PWP interview questions, as well as trainee PWP interview questions. Let’s check them out:

What does PWP work involve?

Psychological wellbeing practitioners (PWPs) are professionals who are educated to examine and assist patients with common mental health issues, such as anxiety disorders and depression, in self-managing their recovery.

What are the essential values in mental health, and which, in your opinion, is the most important?

The essential value in mental health are respect, compassion, care, empathy and ethics. In my opinion, the most important is empathy and care.

What skills and qualities are needed to work in mental health?

Empathy, Compassion and Active Listening are the skills and qualities needed to work in mental health.

What is the complete form of IAPT?

The full of IAPT is Improving Access to Psychological Therapies

Can you tell me about the Stepped care model?

Stepped Care is a way of providing and monitoring care and treatment.

What is the aim of the Stepped Care Model?

The aim is to provide you with the most effective yet least resource-intensive treatment.

What does confidentiality mean to you?

To me, confidentiality means privacy and respecting someone’s wishes.

What are the challenges we face now in the mental health sector?

The challenges we face now in the mental health sector are stigma and lack of funding.

How would you implement health and safety procedures as a PWP?

I would implement mental health and safety by maintaining a holistic view of overall health and wellbeing.

What is clinical governance?

Clinical governance is the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which clinical excellence will flourish

Tell me about yourself and why you want to work in mental health?

I am an empathetic person, and I am very passionate about helping people fight and conquer their mental problems. For this reason, I want to work in mental health.

What are your greatest strengths?

My greatest strengths are- Sincerity, Teamwork, Empathy, Spontaneity and Time management. (This answer depends on your choices. But choose wisely).

What are your most significant weaknesses?

Financial literacy is my significant weakness ( The answer depends solely on you . Here, financial weakness is given as an example).

What experience do you have within the Mental Health sector?

I have a year of working experience in the Mental Health sector

Tell me a time when you worked with other people within the healthcare team to provide an excellent patient or client care?

Answer this question with a nice example.

Explain the situation where you helped to improve people’s lives?

If you don’t have any, then you can make one.

Why should we choose you over the other candidates?

You can emphasise your unique skills and qualities and answer this question.

Talk to me through the steps you would follow in dealing with an upset or confused patient or a client who was in your care?

Answer this question in a structured manner. Exclude irrelevant stories and jargon.

What would you do if you didn’t get on with someone in the mental health team?

Don’t be defensive or aggressive while answering this question. Answer it with a positive tone.

Describe a stressful situation at work and how you handled it?

Keep the answer to this question short, and always remember not to add irrelevant stories.

Can you tell who are the practitioners 2 of the Stepped Care model?

Psychological Wellbeing Practitioners.

On-Demand Accredited Courses

Analyze data quickly and easily with powerful PHP library! All datasets included where beginners welcome!

A PWP’s role is dynamic, with a wide range of challenges. So, a great PWP harnesses specific skills. These are:

Developing good therapeutic relationships with clients.
Capacity to sustain work under pressure.
Ability to self reflect.
Excellent team working skills.
Ability to communicate clearly, effectively and persuasively.
The ability to liaise with a wide range of people and organisations.
Basic IT skills, including database and word processing knowledge.
A high level of enthusiasm and self-motivation.
Good management and leadership skills.
Enthusiastic in using clinical supervision and personal development positively and effectively.

A female psychologist and her female patient discussing some serious issues during counselling session.

Responsibilities of a psychological wellbeing practitioner

A PWP’s responsibilities are immense, an integral part of IAPT. So, for this reason, people in this profession work effortlessly to provide mental health support to the people in need throughout the country. PWP’s offer a wide range of treatments ranging from online and telephone therapy, courses, workshops, and one-to-one work.

A female psychologist and her male client sitting face to face laughing over something during counselling session.

Career opportunities as a PWP

PWP is a fast-paced role, and it keeps on evolving constantly. PWPs can enjoy a range of careers, beginning with establishing specific interests in areas such as older persons, perinatal mental health, Black, Asian, and Minority Ethnic (BAME) communities, and helping individuals with long-term health concerns. Other career options are senior PWPs, lead PWPs, clinical educators, and IAPT managers.

A PWP might also be employed in health centres, GP surgeons, and psychological treatment centres.

Some PWP’s shift their career as CBT therapist and starts their career journey in the clinical psychology sector. So let’s know a little more about CBT.

According to CLINICAL PRACTICE PTSD GUIDELINE , CBT is a type of psychological treatment that has been shown to be useful for a variety of issues, including depression, anxiety disorders, alcohol and drug abuse issues, marital issues, eating disorders, and serious mental disease.

According to several research studies, CBT significantly improves functioning and quality of life. CBT is as successful as, if not more effective, in several trials than other kinds of psychological treatment or psychiatric drugs.

Various accredited online CBT course can provide the necessary training to help anybody master CBT.

PWPs have the option of working full-time or part-time. As a trainee PWP, you’ll be paid at band 4 under the Agenda for Change (AFC) pay structure. Annually, this amount can accumulate to approximately £24,157. You will be paid at band 5 after qualifying; your annual salary can reach up to £30,615 (approx.).

The annual salary of a senior PWP can range from bands 6,7, and 8a, depending on their responsibilities, experience and clinical specialism. This amount can range from £31,365 to £51,668 (approx.).

The salary range can vary in independent and voluntary sectors.

Read our blog if you ever dream of becoming a psychology teacher.

Mental health is a challenging topic, and PWPs are the frontiers while dealing with various mental health problems. We have seen the comprehensive discussions of How to become a PWP, its responsibilities and career opportunities so far in this blog.

In conclusion, we can say that after going through this blog, we got to know about the trainee psychological wellbeing practitioner interview questions & answers and related FAQs, which will further help us for a successful career as a PWP.

Are the trainee psychological wellbeing practitioner interview questions & answers hard?

Not at all. You are all good as long as you are well prepared.

How long is a PWP interview?

I nterview duration depends on many factors, but the interview duration is about 30-40 minutes on average.

Is PWP an excellent job?

Yes, it is a very handsome and competitive career. Because it has lots of opportunities and it is not stressful like other jobs.

How to Become a Child Psychologist UK
What is not a major field in psychology?
How to Become a Physiotherapist – Step by Step Guide
Psychological Bullying by Neighbors – How to Defense and STOP Them
What’s the Difference Between Counselling vs Psychotherapy

Categories:

Like This Article?

Share it on social.

Get the Reddit app

NO MEDICAL ADVICE - This is an NHS discussions subreddit, not a service to ask for, or give medical advice. Welcome to r/NHS, an un-affiliated community for NHS news, sharing information, and discussions.

How to write an introduction for a personal statement for a psychological well-being practitioner diploma/employment role

By continuing, you agree to our User Agreement and acknowledge that you understand the Privacy Policy .

Enter the 6-digit code from your authenticator app

You’ve set up two-factor authentication for this account.

Enter a 6-digit backup code

Create your username and password.

Reddit is anonymous, so your username is what you’ll go by here. Choose wisely—because once you get a name, you can’t change it.

Reset your password

Enter your email address or username and we’ll send you a link to reset your password

Check your inbox

An email with a link to reset your password was sent to the email address associated with your account

Choose a Reddit account to continue

You are using an outdated browser. Please upgrade your browser to improve your experience and security.

Find Health Careers on twitter
Find Health Careers on facebook
Find Health Careers on youtube
Find Health Careers on linkedin
Find Health Careers on instagram
Share on Twitter
Share on Facebook
Share on Linkedln

Psychological wellbeing practitioner

Psychological wellbeing practitioners (PWPs) are trained to assess and support people with common mental health problems – mainly anxiety disorders and depression – to manage their recovery.

You’ll work within NHS Talking Therapies for Anxiety and Depression (formerly IAPT), which provides evidence-based therapies for people with anxiety and depression.

Life as a psychological wellbeing practitioner

You’ll provide treatment for adults from many different backgrounds and will collaborate with a range of professionals in physical health, mental health and social care as well as with community organisations.

conducting patient interviews
helping identify areas where the person wishes to change how they feel, think or behave
carrying out risk assessments
providing phone, online or face-to-face support
liaising with other agencies and signposting patients to useful services, such as housing and employment

You will work with patients on a one-to-one basis or in groups or workshops. You may be based in a GP practice, healthcare centre or community venue such as a library or leisure centre. You may also work from home in some instances.

You will be provided with ongoing supervision to help you engage in self-reflection, seek and respond to feedback, and develop your professional knowledge and skills.

Valeria Souza

Psychological wellbeing practitioner.

Knowing that I am making a difference to people’s lives is rewarding and inspiring.

How much can I earn?

There are nine pay bands and you’ll usually be paid at band 4 while you train. After completing your training you’ll be paid at band 5 with opportunities to progress with experience.

Terms and conditions can vary if you are employed outside the NHS.

How about the benefits?

If you’re employed by the NHS, you’ll also have good holiday entitlement and access to:

fully funded training plus a salary while you train and a job in the service when you qualify
an excellent pension scheme
NHS discounts in shops and restaurants

Must-have skills

excellent interpersonal skills and the ability to relate to a range of people
the ability to work well within a multidisciplinary team
a good understanding of common mental health issues
good written and verbal communication skills
effective time management skills to juggle competing demands in a busy work environment

You'll also need to be able to demonstrate the values of the NHS Constitution .

Entry requirements

You’ll need to complete a British Psychological Society (BPS)-accredited APT training course, which typically consists of 45 days of academic work (one day per week) alongside supervised practice, usually over an academic year. A local NHS Talking Therapies service will employ you while you train and once you’re qualified.

Training is open to people with a range of experience but will help your application if you have some experience of working with people with mental health problems, and good interpersonal skills are essential for the role.

If you have a degree, you can usually take a postgraduate certificate. If you do not have a degree, you can do an equivalent graduate-level qualification or a level 6 apprenticeship. Courses sometimes have different names, so make sure you check the ones you’re interested in are graduate level PWP courses.

The apprenticeship is intended for people without a degree but have useful life experience or would like to make a career change and work for the local community.

From June 2022, all PWPs need to meet the national requirement for registration with either the British Psychological Society (BPS) or British Association for Behavioural and Cognitive Psychotherapies (BABCP). The BPS and BABCP websites have all the details about how the registration process works, including the annual renewal requirement.

How to become a psychological wellbeing practitioner

You need to apply for a post as a trainee or apprentice PWP in an NHS Talking Therapies service. If you are a graduate, you’ll need to apply for a training post and then complete a postgraduate certificate. If you do not have a degree, but want to make use of your life experience, you’ll complete a postgraduate certificate or apply for an apprenticeship PWP position in an NHS Talking Therapies service.

You can search for current opportunities and vacancies below.

Where a career as a psychological wellbeing practitioner can take you

There are many opportunities for you to progress your career. For example, you could specialise in:

long-term conditions – such as diabetes or chronic pain
perinatal health – working with midwives, health visitors and specialist perinatal mental health services to support families
occupational health - supporting NHS staff with mental health problems

Or you could focus on:

training to provide colleague supervision - providing case management and clinical skills supervision to other PWPs
management, for example team management, recruitment and project management
service promotion and leadership, for example developing and overseeing projects and liaising with partners and local organisations
clinical advisory work, for example advising networks of healthcare professionals and specialist groups regionally and nationally
research – either within the NHS or an academic institution

Alternatively, some PWPs go on to train as high intensity therapists, clinical psychologists, counselling psychologists and counsellors.

Visit the funding for psychological professions training programmes web page for more information about NHS funding.  

Progression from PWP to high intensity cognitive behavioural therapy training

If you started your PWP training after September 2018, you will need to pass all the course requirements and work as a PWP for at least two years before being eligible for NHS-funded high intensity CBT training. However, if you already hold a previous core professional qualification recognised by the British Association for Behavioural and Cognitive Psychotherapies (BABCP), you’ll be able to apply for further high intensity training sooner than two years.

Visit the funding for psychological professions training programmes web page for more information on NHS funding.

Live vacancies

Can't find a job in your area? Visit NHS Jobs for more vacancies.

Find a vacancy

Psychological wellbeing practitioner (pwp).

Warrington, WA2 8WA

Psychological Wellbeing Practitioner (PWP) - Band 5

Nuneaton, CV11 5TY

Qualified IAPT Psychological Wellbeing Practitioner (PWP)

Manchester, M16 0PQ

York, YO41 1PS

Oldham, OL1 1RU

Twickenham, TW1 3PA

Warrington, WA2 7NG

Plymouth, PL4 0AH

St Helens, WA9 3DE

Psychological Wellbeing Midwife

Salisbury, SP2 8BJ

London, N1 5LZ

Blandford forum, DT11 8SW

Chard, TA20 1YA

Hull, HU9 5LS

Senior Psychological Wellbeing Practitioner

London, W10 6DZ

Isleworth, TW7 7DJ

Enfield, EN2 8JL

Hemel Hempstead, HP2 5XY

Faversham, ME13 8GD

Ealing, W13 8RA

Trainee Psychological Wellbeing Practitioner

Newport, PO30 2ER

London, SE5 8AZ

Welwyn Garden City, AL8 6UB

Huddersfield, HD1 2LT

SENIOR Psychological Wellbeing Practitioner

Gosport, PO12 1DF Basingstoke, RG22 6PH

Band 5 Psychological Wellbeing Practitioner

Birmingham, B1 3RB

Senior Psychological Wellbeing Practitioner - Aylesbury

Aylesbury, HP20 1EG

Home-Based Qualified Psychological Wellbeing Practitioners

Senior psychological wellbeing practitioner - band 6.

Coventry, CV1 4FS

NHS Talking Therapies Psychological Wellbeing Practitioner Team Lead

Reading, RG6 6BZ

Psychological Wellbeing Practitioner for Children and Young People-CWP

Grimsby, DN32 0QE

Psychological Therapies Manager

London, E14 9WU

Psychological Intervention Facilitator

Lincoln, LN1 1FS

Trainee Psychological Practitioner

Fetal wellbeing midwife.

Uxbridge, UB8 3NN

Wellbeing Team Leader

Ipswich, IP1 2BU

London, SE13 6LH

Children Wellbeing Practitioner

London, SW9 7HH

Counsellor - Community Wellbeing Service

Douglas, IM1 4BR

Compare role
Printer-friendly version
PDF version
Login to Bookmark

Other roles that may interest you

Clinical psychologist
High intensity therapist
Mental health nurse
Counselling psychologist

Help us improve

This form is for you to tell us about something that could be improved about the website or if there's anything wrong, incorrect or inaccurate with what you see.

If you have a query about a career in the NHS, please visit our contact us page and call or email us.

Just added to your cart

My Journey to Becoming a Mental Health Advocate: A Personal Statement Example

My own struggles with mental health inspired me to pursue a career in advocating for others. I believe that everyone deserves access to quality mental healthcare, and I am committed to making that a reality

My interest in mental health was sparked by my own personal journey, which has been marked by struggles with anxiety and depression. Through my own experiences, I have come to realize the critical importance of mental health care and support, and I have developed a strong desire to help others who are going through similar challenges.

To this end, I have pursued a degree in Psychology, which has provided me with a deep understanding of the workings of the human mind, as well as the many factors that can contribute to mental health issues. Through my coursework, I have gained valuable insight into the many different approaches to mental health care, and have developed a strong desire to contribute to this field through my work.

In addition to my academic studies, I have also gained practical experience in the mental health field through volunteer work at a local mental health clinic. In this role, I have worked closely with clients to provide emotional support, as well as practical assistance with tasks such as filling out paperwork and finding appropriate resources. This experience has given me a deep appreciation for the challenges faced by those with mental health issues, as well as a strong desire to help improve access to care and support for those who need it most.

As I look towards the future, I am eager to continue my education and training in mental health care, with the goal of becoming a licensed therapist. I am committed to providing high-quality care to my clients, and to staying up-to-date with the latest research and best practices in the field. Ultimately, my goal is to help people find hope and healing in their lives, and to contribute to a world where mental health issues are treated with the same care and attention as physical health issues.

Growing up, mental health was not something that was talked about in my household or community. It wasn't until I started university that I was exposed to the reality of how prevalent mental health issues are and how it can impact anyone, regardless of their background. This realization ignited a passion within me to learn more about mental health and help those who are struggling with it.

Throughout my academic career, I have focused on studying psychology and human behavior, which has further solidified my interest in mental health. I have also volunteered at a crisis center, where I have assisted individuals who are experiencing mental health crises by providing support and resources. This experience has taught me the importance of empathy, active listening, and the value of providing non-judgmental support.

I believe that pursuing a career in mental health counseling will allow me to utilize my skills and passion to help others in a meaningful way. My goal is to provide a safe and supportive space for individuals to process their emotions and experiences while working collaboratively towards their goals. I am eager to continue learning about the latest developments and advancements in mental health research and treatment, and I am confident that my strong academic record, interpersonal skills, and dedication to the field will enable me to excel in this career.

Ultimately, I want to make a positive impact on the mental health of individuals and communities. My experiences and passion have led me to pursue a graduate program in clinical mental health counseling, and I am excited about the opportunities that lie ahead. I am committed to growing as a mental health professional and making a meaningful difference in the lives of others.

If you're considering applying for a mental health nursing program, a strong

https://grammarholic.com/collections/personal-statements/products/mental-health-nursing-personal-statement

Share Share on Facebook
Tweet Tweet on Twitter
Pin it Pin on Pinterest
Choosing a selection results in a full page refresh.
Press the space key then arrow keys to make a selection.

Clinical and Applied Psychology Unit
NHS Talking Therapies for Anxiety and Depression

IAPT PWP Frequently Asked Questions

What relevant experiences do I need for the course?

Candidates need experience working or volunteering in a role that has allowed them to develop skills in recognising and responding to mental health problems. Some experience of the recognition and management of risk is advantageous, as is the experience of receiving supervision. Relevant personal experience is also applicable here, such as caring for a family member or personal experiences of mental health issues.

Applicants are encouraged to think about the quality and content of their experiences, how they can demonstrate the skills they have acquired from their experiences and how these may be transferable to the role. The emphasis is on the skills and learning rather than the duration of experience or the environment it was acquired in.

I’ve not completed previous study in a health or psychology related discipline, can I apply to the PWP course?

Completing an undergraduate degree in a health or psychology related subject is not a pre-requisite for the course. Candidates from a range of backgrounds with a variety or experiences are welcome and encouraged to apply. Candidates must evidence their ability to study at level 6 of a higher education programme.

I am not employed with an IAPT service; can I apply for PWP training?

At the present time the only route into PWP training is via employment within an IAPT service because the training places are funded by Health Education England and the course is delivered to meet the needs of the expanding psychological workforce.

I only have voluntary experience; can I apply for PWP training?

Candidates need experience working or volunteering in a role that has allowed them to develop skills in recognising and responding to mental health problems and building relationships. This does not need to be paid employment but you must be able to demonstrate your abilities at interview and evidence how the skills you have acquired would be transferable to the PWP role.

I have personal experience of mental illness but no employment or voluntary work in the area. Can I apply?

Candidates need experiences that have allowed them to develop skills in recognising and responding to mental health problems and building relationships with people. Personal experiences or experiences as a carer can be relevant here. Applications from people with lived experience are welcomed.

Related information

Psychological Wellbeing Practitioners Training (PWP)

PWP supervisor information

Applying to Uni
Apprenticeships
Health & Relationships
Money & Finance
Personal Statements
Postgraduate
U.S Universities
University Interviews
Vocational Qualifications
Accommodation
Budgeting, Money & Finance
Health & Relationships
Jobs & Careers
Socialising
Studying Abroad
Studying & Revision
Technology
University & College Admissions

Guide to GCSE Results Day

Finding a job after school or college

Retaking GCSEs

In this section

Choosing GCSE Subjects

Post-GCSE Options

GCSE Work Experience

GCSE Revision Tips

Why take an Apprenticeship?

Applying for an Apprenticeship

Apprenticeships Interviews

Apprenticeship Wage

Engineering Apprenticeships

What is an Apprenticeship?

Choosing an Apprenticeship

Real Life Apprentices

Degree Apprenticeships

Higher Apprenticeships

A Level Results Day 2024

AS Levels 2024

Clearing Guide 2024

Applying to University

SQA Results Day Guide 2024

BTEC Results Day Guide

Vocational Qualifications Guide

Sixth Form or College

International Baccalaureate

Post 18 options

Finding a Job

Should I take a Gap Year?

Travel Planning

Volunteering

Gap Year Blogs

Top Rated Personal Statements

Personal Statement Examples

Writing Your Personal Statement

Postgraduate Personal Statements

International Student Personal Statements

Gap Year Personal Statements

Personal Statement Length Checker

Personal Statement Examples By University

Personal Statement Editing and Review Service

Personal Statement Changes 2025

Personal Statement Template

Job Interviews

Types of Postgraduate Course

Writing a Postgraduate Personal Statement

Postgraduate Funding

Postgraduate Study

Internships

Choosing A College

Ivy League Universities

Common App Essay Examples

Universal College Application Guide

How To Write A College Admissions Essay

College Rankings

Admissions Tests

Fees & Funding

Scholarships

Budgeting For College

Online Degree

Platinum Express Editing and Review Service

Gold Editing and Review Service

Silver Express Editing and Review Service

UCAS Personal Statement Editing and Review Service

Oxbridge Personal Statement Editing and Review Service

Postgraduate Personal Statement Editing and Review Service

I’ve been inspired to expand my studies outside of the classroom by researching other non-curriculum developmental theories such as Piaget’s cognitive developmental theory, giving me a wider understanding and knowledge of how children progress for my future studies of psychology at university, hopefully progressing onto a Masters in Developmental Psychology.

Work experience for working with child psychologists and psychotherapists was not possible at my age, so I chose to help children progress and expand their own potential through experience at a pre-school, private day nursery and music tuition.

My work experience in 2008 at a pre-school is what decided that working with children was a definite career path for me.

My two weeks there helped me become actively involved with the children’s learning and development into a school routine and becoming capable of performing typical everyday tasks such as tidying, encouraging personal hygiene and social skills.

During my 2 day per week experience at Margery’s Private Day Care in 2011, I was able to achieve a lot more with the children as I was more mature than I was during my previous work experience. Through encouragement and patience, two children with particular difficulties participated in activities, successfully ate lunch without anxiety and were polite and kind to other children.

These simple tasks may seem minimal to an outside observer, however accomplishing one of these tasks was a great achievement for the children, who struggled to sit, concentrate and socialise appropriately.

I became a music teacher 2 years ago to 3 children: 2 learn violin and study music theory and all 3 took on the difficult task of learning the guitar.

My students, aged 3-8, were inspired by my attitude to their learning and ability to engage well with them to help them succeed. It was during this job that I understood how children were able to develop and expand their own minds, the joy and the confidence the child gained each time they achieved something they didn’t think they could.

This inspired my want to help children get the best out of their lives, regardless of their struggles.

In 2010, I was part of a programme through the college meeting adolescents of a similar age from Tower Hamlets. They shared experiences of living in a working-class, gang-filled area of London and the devastation that they are subjected to every day of their lives.

The culture shock and sympathy I felt to these adolescents is what chose me to change my focus solely from children, but to teenagers too; I wanted to help adolescents and understand what inspires them to fall into certain stereotypes and ‘gangs’ – a concept I applied to my study on Bandura’s Social Learning Theory.

This eye-opening experience helped me decide I wanted to devote my career to child and adolescent psychotherapy and how psychology was the only degree option I was truly passionate about.

My experiences and my part-time job as well as responsibilities at home have evolved me into a mature, focused woman who can handle tough tasks and situations with cultivation and drive. Balancing these has enabled to improve vital skills needed to succeed such as time management, diligence and responsibility.

I’ve also grown to understand that working with young people requires patience and cognizance, particularly those with special requirements and personal difficulties.

Profile info

This personal statement was written by Heaatherrr for application in 2011.

Heaatherrr's university choices Anglia Polytechnic University Canterbury Christ Church University College University of Dundee Sheffield Hallam University

Green : offer made Red : no offer made

Heaatherrr's Comments

Applied to:

Anglia Ruskin - Psychology Canterbury Christchurch - Psychology Dundee - Psychology Sheffield Hallam - Psychology Winchester - Psychology & Child Development

UPDATE!!! Conditionals from all universities (even though I resat year 12) :D

This personal statement is unrated

Related Personal Statements

Add new comment.

View all courses
Taught postgraduate study
Postgraduate taught degree courses
Postgraduate taught tuition fees
Pre-masters for international students
Funding your postgraduate taught studies
How to apply for a postgraduate taught degree
Postgraduate offer holders - prepare for your studies
Pre-sessional English courses
PhDs and research degrees
Create your own research project
Find a PhD project
Funding your research degree
How to apply for a PhD or research degree
How to make a PhD enquiry
Support while studying your PhD or research degree
Exchanges and studying abroad
Undergraduate study
Undergraduate degree courses
Foundation year programmes
Undergraduate tuition fees
Customise your degree
Funding undergraduate studies
How to apply
Tuition fees and funding
Short courses
Lunchtime evening and weekend courses
Summer schools
Get a prospectus
Student life
Accommodation
Choose your halls of residence
Apply for accommodation
Guaranteed accommodation
Your accommodation options
Accommodation for those with additional requirements
International and pre-sessional students
Postgraduate accommodation
Couples and students with children
Renting privately
Our accommodation areas
Privacy notice
Terms and conditions
Fees and contracts
Southampton
Sports and gyms
Sports facilities
Sports clubs
Watersports centres
Our campuses
Avenue Campus
Boldrewood Innovation Campus
City Centre Campus
Highfield Campus
University Hospital Southampton
Waterfront Campus
Winchester Campus
Join our student community
What's on
Clubs and societies
Sports teams
SUSU places
Representing you
SUSU support and advice
Support and money
Living costs
Academic and mental health support
Support for disabled students
Part-time work
Health services
Research projects
Research areas
Research facilities
Collaborate with us
Institutes, centres and groups
Support for researchers
Faculties, schools and departments
Research jobs
Find people and expertise
Why work with us?
Collaboration
Consultancy
Commercialisation
Use our facilities
Connect with our students
How we operate
Make a business enquiry
International students
International Office
Partnerships and initiatives
Visiting delegations
Visiting fellowships

Low Intensity Cognitive Behavioural Therapy with IAPT PWP Status (PGCert)

Low Intensity Cognitive Behavioural Therapy with IAPT PWP Status (PGCert) starting September 2024 for 1 year

About this course

Learn the skills to work as a psychological wellbeing practitioner (PWP) and help treat people with anxiety and depression on this PGCert in Low Intensity CBT with IAPT PWP Status. Our expert academics will train you to deliver psychological interventions within a stepped care model. You’ll complement your learning with clinical work in approved IAPT service, allowing you to apply theory in a real-life setting.

Cognitive behavioural therapy (CBT) is a talking therapy used to help patients change negative patterns of thinking or behaviour. It’s recommended by The National Institute for Health and Care Excellence (NICE) for the treatment of a range of mental health problems, including depression and anxiety.

This part-time course is aimed at people who want to work in a stepped care Adult Improving Access to Psychological Therapies (IAPT) service.

You’ll learn how to deliver low intensity CBT to support people with common mental health problems, such as anxiety and depression, and help them to self-manage.

By the end of the course you’ll be able to:

interview patients to identify their main difficulties or things they want to change
deliver low intensity CBT interventions by providing information and support for treatment to patients suffering from common mental health problems
operate from an inclusive values base which promotes recovery and respects diversity
manage caseloads
work safely and to high standards
use supervision to aid clinical decision-making

Successful graduates will be able to work as a qualified PWP in an IAPT or low intensity CBT service.

This course is subject to Programme Approval and Review .

We regularly review our courses to ensure and improve quality. This course may be revised as a result of this. Any revision will be balanced against the requirement that the student should receive the educational service expected. Find out why, when, and how we might make changes .

Our courses are regulated in England by the Office for Students (OfS).

Course lead

Your course leader is Mia Kylamartilla .

Accreditations

British Psychological Society (BPS)

Learn more about this subject area.

A student sits in front of a computer and turns to smile towards the camera. She is wearing a head cap that is connected to electrodes to monitor brain activity.

Course location

This course is based at Highfield .

Awarding body

This qualification is awarded by the University of Southampton.

Download the Course Description Document

The Course Description Document details your course overview, your course structure and how your course is taught and assessed.

Entry requirements

You’ll need a 2:2 degree in a clinical, health or science subject.

You should have secured recruitment into a trainee PWP post in an IAPT service.

English language requirements

If English isn't your first language, you'll need to complete an International English Language Testing System (IELTS) to demonstrate your competence in English. You'll need all of the following scores as a minimum:

IELTS score requirements

We accept other English language tests. Find out which English language tests we accept.

Pre-masters

If you don’t meet the English language requirements, you can achieve the level you need by completing a pre-sessional English programme before you start your course.

If you don’t meet the academic requirements, you can complete a pre-master's programme through our partnership with ONCAMPUS. Learn more about the programmes available .

Recognition of professional experience

If you don't have the exact entry requirements, but you have significant work experience in this sector we’ll assess your relevant professional experience, your subject knowledge and your aptitude for learning.

Your application will be considered on individual merit and you may be asked to attend an interview.

Got a question?

Please contact us if you're not sure you have the right experience or qualifications to get onto this course.

Email: [email protected] Tel: +44(0)23 8059 5000

Course structure

The course consists of 3 compulsory modules, all of which you must pass.

We’ll ask you to complete an assessment of practice document which measures clinical competence and the development of skills. This can be evidenced through reflective pieces and completion of supervision logs.

Your supervisor will also sign a final statement to indicate that you’re competent to practise as a psychological wellbeing practitioner (PWP).

Want more detail? See all the modules in the course.

The modules outlined provide examples of what you can expect to learn on this degree course based on recent academic teaching. As a research-led University, we undertake a continuous review of our course to ensure quality enhancement and to manage our resources. The precise modules available to you in future years may vary depending on staff availability and research interests, new topics of study, timetabling and student demand. Find out why, when and how we might make changes .

Year 1 modules

You must study the following modules :

Engagement and Assessment of Patients with Common Mental Health Problems Using Low Intensity CBT (PWP Route)

PWPs assess and support people with common mental health problems in the self-management of their recovery. To do so they must be able to undertake a range of patient-centred assessments and be able to identify the main areas of concern relevant to the as...

Evidenced Based Low Intensity CBT Treatment for Common Mental Health Disorders (PWP Route) Level 7

PWPs aid clinical improvement through the provision of information and support for evidence-based low-intensity psychological treatments and regularly used pharmacological treatments of common mental health problems. Low-intensity psychological treatments...

Values, Diversity and Context (PWP Route) Level 7

PWPs operate at all times from an inclusive values base which promotes recovery and recognises and respects diversity. Diversity represents the range of cultural norms including personal, family, social and spiritual values held by the diverse communities...

Learning and assessment

The learning activities for this course include the following:

lectures
skills training workshops
clinical simulations
group discussions
directed study

We’ll assess you through:

clinical assessment session
therapy recording
clinical case presentation
reflective essay
assessment of practice document

Academic Support

We'll assign you a personal academic tutor, and you'll have access to a senior tutor.

This training will qualify you to work as a PWP in an IAPT or low intensity CBT service.

Careers services at Southampton

We're a top 20 UK university for employability (QS Graduate Employability Rankings 2022). Our Careers, Employability and Student Enterprise team will support you throughout your time as a student and for up to 5 years after graduation. This support includes:

work experience schemes
CV/resume and interview skills workshops
networking events
careers fairs attended by top employers
a wealth of volunteering opportunities
study abroad and summer school opportunities

We have a thriving entrepreneurship culture. You'll be able to take advantage of:

our dedicated start-up incubator, Futureworlds
a wide variety of enterprise events run throughout the year
our partnership in the world’s number 1 business incubator, SETsquared

Fees, costs and funding

Tuition fees.

Health Education England (HEE) will pay your fees for this course.

Fees for a year's study:

UK students pay £4,782.
This course is not available to EU and international students.

Check fees for other versions of this course .

What your fees pay for

Your tuition fee covers the full cost of tuition and any exams. The fee you pay will remain the same each year from when you start studying this course. This includes if you suspend and return.

Find out how to pay your tuition fees .

Accommodation and living costs, such as travel and food, are not included in your tuition fees. There may also be extra costs for retake and professional exams.

accommodation costs
living costs
budgeting advice
fees, charges and expenses regulations

10% alumni discount

If you’re a graduate of the University of Southampton, you could be eligible for a 10% discount on your postgraduate tuition fees.

Funding your postgraduate studies

A variety of additional funding options may be available to help you pay for your master’s study. Both from the University and other organisations.

Funding for international students

Find out about funding you could get as an international student.

Use the 'apply for this course' button on this page to take you to our online application form.
Search for the course you want to apply for.
Complete the application form and upload any supporting documents.
Submit your application.

For further details, read our step by step guide to postgraduate taught applications .

Application deadlines

Contact your Service or Trust Lead for information on application deadlines.

Supporting information

When you apply you’ll need to submit a personal statement explaining why you want to take the course.

You’ll need to include information about:

your knowledge of the subject area
why you want to study a postgraduate qualification in this course
how you intend to use your qualification

You'll also need to submit two academic references.

Please include the required paperwork showing your first degree and your IELTS English language test score (if you are a non-native English speaker) with your application. Without these, your application may be delayed.

What happens after you apply

You'll be able to track your application through our online Applicant Record System.

We will aim to send you a decision 6 weeks after you have submitted your application.

Unfortunately, due to number of applications we receive, we may not be able to give you specific feedback on your application if you are unsuccessful.

Equality and diversity

We treat and select everyone in line with our Equality and Diversity Statement .

Related courses

psychological wellbeing practitioner personal statement example

Advanced Clinical Practice and Supervision (Senior Wellbeing Practitioner)

Advanced supervision, cognitive behavioural therapy (cbt) (anxiety and depression), cognitive behavioural therapy (cbt) (severe mental health), education mental health practitioner, foundations of clinical psychology, health psychology.

A study participant is prepared for a facial electromyography experiment

Psychology: Cognitive Psychology

Psychology: research methods, psychology: social psychology.

Course modules
Acoustical engineering
Biomedical and medical engineering
Civil engineering
Every day I’m completely immersed in an environment that’s creative in all aspects
Everything I learn feels so relevant, even If it’s a subject rooted in the past
Maritime engineering
Photonics and optoelectronics
Social statistics and demography
A missing link between continental shelves and the deep sea: Have we underestimated the importance of land-detached canyons?
A seismic study of the continent-ocean transition southwest of the UK
A study of rolling contact fatigue in electric vehicles (EVs)
Acoustic monitoring of forest exploitation to establish community perspectives of sustainable hunting
Acoustic sensing and characterisation of soil organic matter
Advancing intersectional geographies of diaspora-led development in times of multiple crises
Aero engine fan wake turbulence – Simulation and wind tunnel experiments
Against Climate Change (DACC): improving the estimates of forest fire smoke emissions
All-in-one Mars in-situ resource utilisation (ISRU) system and life-supporting using non-thermal plasma
An electromagnetic study of the continent-ocean transition southwest of the UK
An investigation of the relationship between health, home and law in the context of poor and precarious housing, and complex and advanced illness
Antibiotic resistance genes in chalk streams
Being autistic in care: Understanding differences in care experiences including breakdowns in placements for autistic and non-autistic children
Biogeochemical cycling in the critical coastal zone: Developing novel methods to make reliable measurements of geochemical fluxes in permeable sediments
Bloom and bust: seasonal cycles of phytoplankton and carbon flux
British Black Lives Matter: The emergence of a modern civil rights movement
Building physics for low carbon comfort using artificial intelligence
Building-resolved large-eddy simulations of wind and dispersion over a city scale urban area
Business studies and management: accounting
Business studies and management: banking and finance
Business studies and management: decision analytics and risk
Business studies and management: digital and data driven marketing
Business studies and management: human resources (HR) management and organisational behaviour
Business studies and management: strategy, innovation and entrepreneurship
Carbon storage in reactive rock systems: determining the coupling of geo-chemo-mechanical processes in reactive transport
Cascading hazards from the largest volcanic eruption in over a century: What happened when Hunga Tonga-Hunga Ha’apai erupted in January 2022?
Characterisation of cast austenitic stainless steels using ultrasonic backscatter and artificial intelligence
Climate Change effects on the developmental physiology of the small-spotted catshark
Climate at the time of the Human settlement of the Eastern Pacific
Collaborative privacy in data marketplaces
Compatibility of climate and biodiversity targets under future land use change
Cost of living in modern and fossil animals
Creative clusters in rural, coastal and post-industrial towns
Deep oceanic convection: the outsized role of small-scale processes
Defect categories and their realisation in supersymmetric gauge theory
Defining the Marine Fisheries-Energy-Environment Nexus: Learning from shocks to enhance natural resource resilience
Design and fabrication of next generation optical fibres
Developing a practical application of unmanned aerial vehicle technologies for conservation research and monitoring of endangered wildlife
Development and evolution of animal biomineral skeletons
Development of all-in-one in-situ resource utilisation system for crewed Mars exploration missions
Ecological role of offshore artificial structures
Effect of embankment and subgrade weathering on railway track performance
Efficient ‘whole-life’ anchoring systems for offshore floating renewables
Electrochemical sensing of the sea surface microlayer
Engagement with nature among children from minority ethnic backgrounds
Enhancing UAV manoeuvres and control using distributed sensor arrays
Ensuring the Safety and Security of Autonomous Cyber-Physical Systems
Environmental and genetic determinants of Brassica crop damage by the agricultural pest Diamondback moth
Estimating marine mammal abundance and distribution from passive acoustic and biotelemetry data
Evolution of symbiosis in a warmer world
Examining evolutionary loss of calcification in coccolithophores
Explainable AI (XAI) for health
Explaining process, pattern and dynamics of marine predator hotspots in the Southern Ocean
Exploring dynamics of natural capital in coastal barrier systems
Exploring the mechanisms of microplastics incorporation and their influence on the functioning of coral holobionts
Exploring the potential electrical activity of gut for healthcare and wellbeing
Exploring the trans-local nature of cultural scene
Facilitating forest restoration sustainability of tropical swidden agriculture
Faulting, fluids and geohazards within subduction zone forearcs
Faulting, magmatism and fluid flow during volcanic rifting in East Africa
Fingerprinting environmental releases from nuclear facilities
Flexible hybrid thermoelectric materials for wearable energy harvesting
Floating hydrokinetic power converter
Glacial sedimentology associated subglacial hydrology
Green and sustainable Internet of Things
How do antimicrobial peptides alter T cell cytokine production?
How do calcifying marine organisms grow? Determining the role of non-classical precipitation processes in biogenic marine calcite formation
How do neutrophils alter T cell metabolism?
How well can we predict future changes in biodiversity using machine learning?
Hydrant dynamics for acoustic leak detection in water pipes
If ‘Black Lives Matter’, do ‘Asian Lives Matter’ too? Impact trajectories of organisation activism on wellbeing of ethnic minority communities
Illuminating luciferin bioluminescence in dinoflagellates
Imaging quantum materials with an XFEL
Impact of neuromodulating drugs on gut microbiome homeostasis
Impact of pharmaceuticals in the marine environment in a changing world
Impacts of environmental change on coastal habitat restoration
Improving subsea navigation using environment observations for long term autonomy
Information theoretic methods for sensor management
Installation effect on the noise of small high speed fans
Integrated earth observation mapping change land sea
Interconnections of past greenhouse climates
Investigating IgG cell depletion mechanisms
Is ocean mixing upside down? How mixing processes drive upwelling in a deep-ocean basin
Landing gear aerodynamics and aeroacoustics
Lightweight gas storage: real-world strategies for the hydrogen economy
Long-term change in the benthos – creating robust data from varying camera systems
Machine learning for multi-robot perception
Marine ecosystem responses to past climate change and its oceanographic impacts
Mechanical effects in the surf zone - in situ electrochemical sensing
Microfluidic cell isolation systems for sepsis
Migrant entrepreneurship, gender and generation: context and family dynamics in small town Britain
Miniaturisation in fishes: evolutionary and ecological perspectives
Modelling high-power fibre laser and amplifier stability
Modelling soil dewatering and recharge for cost-effective and climate resilient infrastructure
Modelling the evolution of adaptive responses to climate change across spatial landscapes
Nanomaterials sensors for biomedicine and/or the environment
New high-resolution observations of ocean surface current and winds from innovative airborne and satellite measurements
New perspectives on ocean photosynthesis
Novel methods of detecting carbon cycling pathways in lakes and their impact on ecosystem change
Novel technologies for cyber-physical security
Novel transparent conducting films with unusual optoelectronic properties
Novel wavelength fibre lasers for industrial applications
Ocean circulation and the Southern Ocean carbon sink
Ocean influence on recent climate extremes
Ocean methane sensing using novel surface plasmon resonance technology
Ocean physics and ecology: can robots disentangle the mix?
Ocean-based Carbon Dioxide Removal: Assessing the utility of coastal enhanced weathering
Offshore renewable energy (ORE) foundations on rock seabeds: advancing design through analogue testing and modelling
Optical fibre sensing for acoustic leak detection in buried pipelines
Optimal energy transfer in nonlinear systems
Optimizing machine learning for embedded systems
Oxidation of fossil organic matter as a source of atmospheric CO2
Partnership dissolution and re-formation in later life among individuals from minority ethnic communities in the UK
Personalized multimodal human-robot interactions
Preventing disease by enhancing the cleaning power of domestic water taps using sound
Quantifying riparian vegetation dynamics and flow interactions for Nature Based Solutions using novel environmental sensing techniques
Quantifying the response and sensitivity of tropical forest carbon sinks to various drivers
Quantifying variability in phytoplankton electron requirements for carbon fixation
Resilient and sustainable steel-framed building structures
Resolving Antarctic meltwater events in Southern Ocean marine sediments and exploring their significance using climate models
Robust acoustic leak detection in water pipes using contact sound guides
Silicon synapses for artificial intelligence hardware
Smart photon delivery via reconfigurable optical fibres
The Gulf Stream control of the North Atlantic carbon sink
The Mayflower Studentship: a prestigious fully funded PhD studentship in bioscience
The calming effect of group living in social fishes
The duration of ridge flank hydrothermal exchange and its role in global biogeochemical cycles
The evolution of symmetry in echinoderms
The impact of early life stress on neuronal enhancer function
The oceanic fingerprints on changing monsoons over South and Southeast Asia
The role of iron in nitrogen fixation and photosynthesis in changing polar oceans
The role of singlet oxygen signaling in plant responses to heat and drought stress
Time variability on turbulent mixing of heat around melting ice in the West Antarctic
Triggers and Feedbacks of Climate Tipping Points
Uncovering the drivers of non-alcoholic fatty liver disease progression using patient derived organoids
Understanding recent land-use change in Snowdonia to plan a sustainable future for uplands: integrating palaeoecology and conservation practice
Understanding the role of cell motility in resource acquisition by marine phytoplankton
Understanding the structure and engagement of personal networks that support older people with complex care needs in marginalised communities and their ability to adapt to increasingly ‘digitalised’ health and social care
Unpicking the Anthropocene in the Hawaiian Archipelago
Unraveling oceanic multi-element cycles using single cell ionomics
Unravelling southwest Indian Ocean biological productivity and physics: a machine learning approach
Using acoustics to monitor how small cracks develop into bursts in pipelines
Using machine learning to improve predictions of ocean carbon storage by marine life
Vulnerability of low-lying coastal transportation networks to natural hazards
Wideband fibre optical parametric amplifiers for Space Division Multiplexing technology
Will it stick? Exploring the role of turbulence and biological glues on ocean carbon storage
X-ray imaging and property characterisation of porous materials
Postgraduate Taught Diversity Scholarship (Environmental and Life Sciences)
Southampton Business School Postgraduate UK Scholarship
Southampton Genomics Talent Scholarship
Southampton History Patricia Mather and Helen Patterson Scholarship
Southampton MA Holocaust scholarships
Southampton Philosophy David Humphris-Norman Scholarship
Southampton UK Alumni Music Scholarship
The National Institute for Health and care Research South Central INSIGHT Programme
Winchester School of Art Progression Scholarship
Southampton Physics and Astronomy Achievement Scholarship
GREAT Scholarships 2024 – Greece
Undergraduate scholarships for UK students
Winchester School of Art Postgraduate Global Talent Scholarship
Engineering Global Talent Scholarship
Southampton University Corporate Civil Engineering Scholarship Scheme
Merit scholarships for international postgraduates
Merit scholarships for international undergraduates
Scholarships, awards and funding opportunities
Becas Chile Scholarship
Chevening Scholarships
China Scholarship Council Scholarships
COLFUTURO Scholarships
Commonwealth Distance Learning Scholarships
Commonwealth Master's Scholarships
Commonwealth PhD Scholarships
Commonwealth PhD Scholarships for high income countries
Commonwealth Shared Scholarships
Commonwealth Split-Site Scholarships
FIDERH Scholarships
Fulbright Awards
FUNED Scholarships
Great Scholarships 2024 – India
Great Scholarships 2024 – Bangladesh
Great Scholarships 2024 – Mexico
Great Scholarships 2024 – Nigeria
Marshall Scholarship
Saïd Foundation Scholarships
British Council Scholarships for Women in STEM
Xiamen University PhD Scholarships
GREAT scholarships for justice and law 2024 – Indonesia
Scholarship terms and conditions
Southampton Education Civic Scholarship
Southampton Ageing and Gerontology Talent Scholarship
Southampton Canadian Prestige Scholarship for Law
Southampton Presidential International Scholarship
Continuing professional development
Archers Road
City Gateway
Erasmus Park
Highfield Hall
Orion Point
Wessex Lane
Cancer Sciences Protein Facility
Geotechnical Centrifuge
Maritime Robotics and Instrumentation Laboratory (MRIL)
Active Living
Advanced Fibre Applications
Advanced Laser Laboratory
Advanced Project Management Research Centre
Antibody and Vaccine Group
Astronomy Group
Autism Community Research Network @ Southampton (ACoRNS)
Bioarchaeology and Osteoarchaeology at Southampton (BOS)
Bladder and Bowel Management
Cell and Developmental Biology
Centre for Defence and Security Research
Centre for Developmental Origins of Health and Disease
Centre for Digital Finance
Centre for Eastern European and Eurasian Studies (CEEES)
Centre for Empirical Research in Finance and Banking (CERFIB)
Centre for Geometry, Topology, and Applications
Centre for Global Englishes
Centre for Global Health and Policy (GHaP)
Centre for Health Technologies
Centre for Healthcare Analytics
Centre for Human Development, Stem Cells and Regeneration
Centre for Imperial and Postcolonial Studies
Centre for Inclusive and Sustainable Entrepreneurship and Innovation (CISEI)
Centre for International Film Research (CIFR)
Centre for International Law and Globalisation
Centre for Internet of Things and Pervasive Systems
Centre for Justice Studies
Centre for Linguistics, Language Education and Acquisition Research
Centre for Machine Intelligence
Centre for Maritime Archaeology
Centre for Medieval and Renaissance Culture (CMRC)
Centre for Modern and Contemporary Writing (CMCW)
Centre for Music Education and Social Justice
Centre for Political Ethnography (CPE)
Centre for Research in Accounting, Accountability and Governance
Centre for Research on Work and Organisations
Centre for Resilient Socio-Technical Systems
Centre for Transnational Studies
Child and Adolescent Research Group
Clinical Ethics, Law and Society (CELS)
Computational Nonlinear Optics
Cyber Security Academy
Data Science Group
Digital Oceans
EPSRC and MOD Centre for Doctoral Training in Complex Integrated Systems for Defence and Security
Economic Theory and Experimental Economics
Economy, Society and Governance
Electrical Power Engineering
Environmental Hydraulics
Gas Photonics in Hollow Core Fibres 
Geochemistry
Global Health (Demography)
Global Health Community of Practice
Gravity group
Healthy Oceans
High Power Fibre Lasers
Hollow Core Fibre
Human Genetics and Genomic Medicine
Infrastructure Group
Institute of Maritime Law (IML)
Integrated Photonic Devices
Integrative Molecular Phenotyping Centre
Interdisciplinary Musculoskeletal Health
International Centre for Ecohydraulics Research (ICER)
Language Assessment and Testing Unit (LATU)
Laser-Direct-Write (LDW) Technologies for Biomedical Applications
Law and Technology Centre
Long Term Conditions
Magnetic Resonance
Mathematical Modelling
Medicines Management
Molecular and Precision Biosciences
Multiwavelength Accretion and Astronomical Transients
National Biofilms Innovation Centre (NBIC)
National Centre for Research Methods
National Infrastructure Laboratory
Nature-Based Ocean Solutions
Nonlinear Semiconductor Photonics
Ocean Perception Group
Operational Research
Optical Engineering and Quantum Photonics Group
Paediatrics and Child Health - Clinical and Experimental Sciences
People, Property, Community
Photonic Systems, Circuits and Sensors Group
Physical Optics
Primary Care Research Centre
Product Returns Research Group (PRRG)
Quantum, Light and Matter Group
Silica Fibre Fabrication
Silicon Photonics
Skin Sensing Research Group
Southampton Centre for Nineteenth-Century Research
Southampton Ethics Centre
Southampton Health Technology Assessments Centre (SHTAC)
Southampton High Energy Physics group
Southampton Imaging
Southampton Theory Astrophysics and Gravity (STAG) Research Centre
Stefan Cross Centre for Women, Equality and Law
String theory and holography
The India Centre for Inclusive Growth and Sustainable Development
The Parkes Institute
Tony Davies High Voltage Laboratory
Ultrafast X-ray Group
Vision Science
WSA Exchange
Work Futures Research Centre (WFRC)
Departments

trainee psychological well-being practitioner (PWP)

Quick reply, related discussions.

PWP/Counselling/Psychology
Trainee PWP degree or BSc Psychology degree ?
Psychological Wellbeing Practitioner career - family friendly?
Is it too early for me to apply to the trainee PWP course at UCL?
Psychology degree prospects
What to do after a BSc in psychology?
Trainee Psychological Wellbeing Practitioner and Assistant Psychologist
UCL Trainee PWP September 2023
Clinical Psychology
What is the different between a pwp and cwb and mhwp?
Psychology with Counselling degree advice...
Road to Clinical Psychologist
UCL PWP February 2023
Psychology or Law?
Can I do masters in clinic/child psychology
Nowhere to go with my Psychology career
Aspiring Clinical Psychologist
QMUL - MSc Mental Health: Psychological Therapies - Worth it?
Psychology Masters and experiences
Jobs in psychology

Last reply 6 days ago

Posted 2 weeks ago

Last reply 2 weeks ago

Last reply 3 weeks ago

Posted 3 weeks ago

Last reply 1 month ago

Posted 1 month ago

Last reply 2 months ago

Last reply 3 months ago

Last reply 4 months ago

Posted 5 months ago

Last reply 5 months ago

Articles for you

What can you do with an arts degree?

Finding a university place in Ucas Clearing 2024: 10 top tips to help you get ready

Top 10 tips for Ucas Clearing 2024

Bringing business people into the classroom: what students learn from industry professionals

Open access
Published: 03 August 2024

Psychological stress of general practitioners in the care of patients with palliative care needs: an exploratory study

Verena Lopez 1 ,
Piet van der Keylen 1 , 2 ,
Thomas Kühlein 1 &
Maria Sebastião 1

BMC Palliative Care volume 23 , Article number: 197 ( 2024 ) Cite this article

Metrics details

In Germany, general practitioners play a pivotal role in palliative care provision. Caring for patients with palliative care needs can be a burden for general practitioners, highlighting the importance of self-care and mental health support. This study aimed to explore the role of palliative care in general practitioners’ daily work, the stressors they experience, their coping mechanisms, and the potential benefits of Advance Care Planning in this context.

An exploratory approach was employed, combining a short quantitative survey with qualitative interviews. The analysis was based on a structuring qualitative content analysis, following a deductive-inductive procedure and integrating the Stress-Strain Model and Lazarus’ Transactional Model of Stress and Coping. We recruited eleven general practitioners to take part in the study.

General practitioners viewed palliative care as integral to their practice but faced challenges such as time constraints and perceived expertise gaps. Societal taboos often hindered conversations on the topic of death. Most general practitioners waited for their patients to initiate the topic. Some general practitioners viewed aspects of palliative care as potentially distressing. They used problem-focused (avoiding negative stressors, structuring their daily schedules) and emotion-focused (discussions with colleagues) coping strategies. Still, general practitioners indicated a desire for specific psychological support options. Advance Care Planning, though relatively unfamiliar, was acknowledged as valuable for end-of-life conversations.

Conclusions

Palliative care can be associated with negative psychological stress for general practitioners, often coming from external factors. Despite individual coping strategies in place, it is advisable to explore concepts for professional psychological relief.

Trial registration

Not registered.

Peer Review reports

Palliative care is defined as “ the active holistic care of individuals across all ages with serious health-related suffering due to severe illness and especially of those near the end of life. It aims to improve the quality of life of patients , their families and their caregivers ” [ 1 ]. Palliative care has a positive effect on end-of-life care - for example, in reducing potentially aggressive medical interventions such as intensive medical treatment [ 2 ]. Between 69 and 82% of terminally ill patients need palliative care [ 3 ]. According to the World Health Organization (WHO) in 2020, an estimated 56.8 million people required palliative care globally. However, only about 14% of those in need received it. In the coming years, more patients will need palliative care services, primarily driven by the ageing of the population and the growing burden of diseases [ 4 ].

Palliative care can be provided in an ambulatory or an inpatient setting. In Germany, 76% of patients expressed a preference for dying at home [ 5 ] which means that general practitioners (GPs) play a central role in providing palliative care [ 6 ]. In Germany, basic knowledge of palliative medicine is part of the training requirements for becoming a GP [ 7 ]. GPs who wish to expand their expertise can participate in further training programs. Specialized Ambulatory Palliative Care Teams (SAPCT) step in when patients’ symptoms and needs exceed the capabilities of GPs.

Caring for patients with palliative care needs can become burdensome for GPs, e.g. due to time constraints [ 8 , 9 ]. This lack of time is intensified by a high caseload and the fact that patients with palliative care needs often require more time and attention than other patient groups [ 8 ]. Parallels, such as similar age or character traits, may lead to reflections on their own mortality and death, presenting a negative psychological burden for GPs [ 10 ]. This burden may intensify when patients express their wish for hastening death [ 11 , 12 ]. Currently, there is little information on how GPs in Germany conduct conversations about end-of-life care [ 13 ]. Advance Care Planning (ACP) as a proactive process in which patients discuss and document their preferences regarding future medical decisions could be helpful [ 14 ]. Although the financing of ACP was regulated by the Hospice and Palliative Care Act passed in 2015, the concept is not yet widely established in Germany [ 15 ]. It has been shown that ACP has positive effects on care for patients [ 16 ]. It remains to be seen whether ACP also has a positive influence on the mental health of GPs.

In Germany, legal frameworks allow treatment limitations (e.g. no artificial nutrition) and palliative care measures (e.g. sufficient pain relief despite potential shortening of life or palliative sedation) but explicitly prohibit active euthanasia [ 17 ]. Assisted suicide, involving the provision of lethal substances, exists within a legal grey area [ 17 ]. Although a 2020 ruling by the Federal Constitutional Court emphasized the right to self-determined dying, legal uncertainties remain (BVerfG, Guidelines to the Judgment of the Second Senate, February 26, 2020, Art. 2 para. 1). This uncertainty may lead to an additional burden for GPs when caring for patients with palliative care needs.

The high rates of burnout among GPs (32–43%) [ 18 ] and the high suicide rate among physicians in general [ 19 ] highlight the importance of mental health and self-care. As dealing with death can be a potential psychological stressor for GPs, attention should be directed towards this topic. Stress reactions do not inherently result in health damage [ 20 ]. The decisive factor is the interplay between the stressors, their intensity, timing, and individual resources. Therefore, this study aimed to explore (1) the role of palliative care in the daily work of GPs, (2) the psychological and emotional stress experienced by GPs in this context, (3) their possible coping mechanisms, and (4) if ACP can be supportive for the GPs’ mental health in the palliative care setting.

Study design

An exploratory approach with a short quantitative survey followed by a qualitative interview was chosen to understand the GPs’ perspective. The ethics committee of the Friedrich-Alexander University Erlangen-Nürnberg approved the study (file number 21-377-B).

Recruitment and setting

The recruitment was conducted through contacts of the Institute of General Practice. We used different recruitment channels. GPs were invited to participate in the study via the Institute’s newsletter (approximately 250 recipients). We also distributed information at various events (e.g. research symposium for GPs). We asked GPs to further spread the study (snowball system). In addition, 30 randomly selected practices in Bavaria were made aware of the study by e-mail and/or telephone. Inclusion criteria were: GPs practicing in Bavaria, Germany, including doctors-in-training and GPs who retired within the last year. We planned for 15–20 interviews to be conducted. Prospective participants received an invitation letter and study information ( n = 33). GPs expressing interest subsequently received the data protection declaration, consent form for signature, and a brief survey for completion ( n = 11). The most frequently cited reason for non-participation was lack of time. The interviewer (VL, female, student of human medicine) and the GPs did not know each other beforehand.

Data collection

The project team developed the interview guide. Based on a literature review, we created mind maps for each research question which depicted various influencing factors and elements. After structuring and summarizing, four thematic blocks emerged for the interview guide: (1) Experience with palliative care as a GP, (2) Patients’ death wishes and the resulting emotions on the side of the GPs, (3) Dealing with any psychological stressors, and (4) Suggestions for coping with psychological stressors in palliative care (including questions about ACP) (Supplemental file 1 ).

The interview guide was pre-tested with two GPs. After the pre-test, a written definition of ACP was incorporated into the interview guide, and questions related to ACP were modified. The quantitative survey comprised questions concerning socio-demographic status and a subset of 15 questions (drawn from a total of 144) sourced from the “ Questionnaire on attitudes towards dying , death , and the afterlife ” (FESTD) [ 21 ] (Supplemental file 2 ). Questions were chosen based on the relevance to the care of patients with palliative care needs and to gain an impression of the GPs’ attitude to dying and death. The participants received the paper questionnaire by post or email in advance and were asked to complete and return it before the interview.

From 12/2021 to 11/2022 data collection took place. VL conducted the interviews ( n = 11) via Zoom (zoom.us, San José, USA). The interviews (35–80 min, on average 60 min) were digitally audio-recorded and later transcribed verbatim using the software f4 (Marburg, Germany). Transcripts were not provided to participants. In addition, protocols of the interviews were written to include e.g. first memos. The memos contained first ideas for the data analysis. These were later used to familiarize ourselves with the material as a first step of data analysis.

Data analysis

As a basis for our analysis, we combined two models: 1) The Stress-Strain-Model , developed by Rohmert and Rutenfranz [ 22 ], and the Transactional Model of Stress and Coping developed by Lazarus [ 20 ]. We used these two models to form our deductive categories. The Stress-Strain-Modell delineates the causal relationship between mental stress and strain. The various workload influences affect the individual with different preconditions (Fig. 1 ).

Combination of the two stress models used for analysis

The Transactional Model of Stress and Coping describes the interaction between individuals and their environment as a dynamic and reciprocally influential process [ 20 ] (Fig. 1 ). When an individual is confronted with a stressor, a primary appraisal takes place in which the stressor is classified as positive, irrelevant, or threatening. This means that a stressor is not necessarily associated with a threat and can also be evaluated positively. Only if a threat is perceived, a secondary appraisal follows in which the available resources are assessed. Insufficient resources lead to stress reactions.

Negative consequences arise from the mismatch between work-related demands (such as job contenct or work organization) and individual preconditions (such as personal attitude or qualification). Consequently, identical work-related stressors can lead to varying stress levels and outcomes in the short and long term for diverse individuals or on different occasions. Coping strategies become necessary to restore a balance between demands and resources. Those coping strategies can be problem-oriented (modifying the situation) or emotion-oriented (changing the attitude). Ultimately, the situation is re-evaluated.

The analysis was based on the structuring qualitative content analysis by Kuckartz and Rädiker [ 23 ], following a deductive-inductive procedure and using the software program MAXQDA Plus 2020. Initially, VL wrote a case summary for each participant. VL and MS deductively formed a system of categories based on the two stress models. The categories were provided with a short description. During analysis, VL added an example for each category. VL applied the categories to the material. The category system was inductively expanded by new categories and re-organized. After coding eight of the interviews, no new categories were added, indicating data saturation. All data material was coded using the final category system (Supplemental file 3 ). On an individual level, we compared answers from the questionnaire and interviews to identify discrepancies. We then checked whether these discrepancies were also found in other interviews.

Quality assurance

TK (male, Chair of Institute, GP) and MS (female, senior researcher, Public Health) have extensive knowledge in qualitative research. Before data collection, VL was trained in qualitative data collection and analysis. All categories were continuously discussed by the project team (VL, PvK, TK, MS) meeting the standard of consensual validation. VL kept a research diary to reflect on her role and possible influence during the research process. The reporting of the study follows the “ Consolidated criteria for reporting qualitative research ” (COREQ) [ 24 ].

In our study, 11 GPs (6 men, 5 women) of various age groups participated (Table 1 ).

The presentation of the results follows the research questions, commencing with the role of palliative care (Q1), followed by an exploration of potential stressors (Q2), and coping mechanisms (Q3) and concluding with ACP (Q4).

Role of palliative care

The central objective of GPs in palliative care is to alleviate suffering and thus maintain quality of life (GP1; GP2; GP3; GP9). Palliative care holds a high to very high significance in the daily practice of GPs. It is perceived as an “ inherent responsibility of general practice ” (GP7) to accompany patients until the end of their lives. This perception was also reflected in their professional identity: GPs saw themselves as medical companions from childhood to death. The importance was not necessarily directly proportional to the actual level of palliative care provided: “ For me , it is very important […]. But fortunately , it is a small percentage of patients ” (GP10). The average number of patients with palliative care needs cared for per year showed a wide range. Most GPs ( n = 8) stated that they treat up to 20 patients yearly, the maximum was over 60 patients ( n = 1). The majority (10 out of 11) stated that between 0 and 20 patients with palliative care needs die in their care over the span of one year (Supplemental information 2 ).

Psychological and emotional stress experienced by GPs

External stressors, job content.

For GPs, palliative care was considered a “ routine aspect ” (GP9), however, they reported a significant imbalance between effort and reimbursement (GP4; GP7; GP9). In general, GPs expressed openness to discussing death and related wishes with their patients. Some emphasized a moral obligation to address these topics (GP5), highlighting the ethical dimension involved. However, there were clear differences in how these discussions were initiated. While some GPs actively approached patients to discuss end-of-life care (GP3; GP4; GP7; GP9), the majority of them waited for patients to raise the topic. Many GPs appreciate when patients initiate these conversations, as it signals openness to the topic and provides a starting point. The most common triggers were critical health conditions, acute deteriorations, an unfavorable prognosis (GP2; GP4; GP7; GP9) or death in the patient’s social environment (GP9; GP10). The identified triggers also determine the primary target groups for these discussions: patients with palliative care needs, chronically ill individuals, older patients, and their respective relatives, along with those who actively approach GPs regardless of age or health status (GP2; GP3; GP7; GP8; GP9; GP10; GP11). Even with a specific trigger, GPs described that they sometimes hesitate to initiate discussions to avoid overwhelming patients. GPs also expressed concerns about potentially diminishing patients’ hope and will to live through discussions about death (GP4; GP6; GP8).

Central to these conversations is the understanding of patients’ preferences and wishes (GP1; GP3; GP5; GP7; GP8). This includes evaluating whether home care is feasible and if a move to a hospice is necessary and desired. The involvement of family members in end-of-life care and their alignment with the patients’ wishes is crucial (GP9). Requests for physician-assisted suicide were mentioned less frequently, and some GPs expressed relief about that: “ many patients were so hopeless and deeply sad at the end , […] that they said ‘I would prefer to be dead right now.’ But I’m so glad that not a single person asked me if I could help them.” (GP10). When no specific wishes were documented, the presumed patient will has to be determined in acute situations. This can lead to challenging situations for all parties involved (GP7; GP8).

Work organization

GPs expressed a fundamental time constraint, noting that “ the main part of (…) caring for dying patients is certainly a verbal one and that takes time. And the second point of course , is that these patients are often so ill that they need home visits ” (GP1). A certain level of flexibility is often necessary because “ palliative care is always something spontaneous and difficult to plan. I can’t really say I’ll keep ten to twelve free in my diary on Friday’ or something; that’s not really possible ” (GP6). This time challenge becomes more pronounced when patients have not made any or only insufficient decisions regarding palliative care. GPs described advance care planning as time-consuming consultations to explain medical terms and treatment options (GP5; GP10). While justified given the gravity of the decisions, these lengthy discussions pose organizational challenges for GPs (GP1; GP2).

Work environment

Caring at home for patients with palliative care needs is commonly favored and often aligns with the patients’ wishes. The GPs named positive impacts of the familiar environment on the psychological well-being of patients (GP1). In certain situations, such as when the nursing care needs cannot be adequately met, GPs preferred hospice care. Some interviewees explicitly assessed any demand for round-the-clock availability as a burden (GP7; GP8).

The GPs mentioned the time constraints as the most prominent obstacle in the ambulatory setting (GP6). Another major disadvantage is that fewer resources are available compared to a hospital setting. Should instrumental examinations be necessary, this is associated with greater effort (GP1). The GPs addressed the lack of personal expertise and experience in approaching such challenges (GP1) (Also: Individual Precondition - Qualification ). The work environment of GPs entails having limited on-site support, as exemplified by involving colleagues (GP6). The burden of bearing sole responsibility for decisions, without or with only limited chances for reassurance from colleagues or relatives, was perceived as challenging (GP9).

Legal context

The legal context played a prominent role in all the interviews. GPs’ explicit and implicit remarks showed that they perceived a lack of comprehensive legal protection when providing care to patients with palliative care needs, especially when it came to assisted suicide. This legal ambiguity has the potential to induce distress. Their own values and knowledge factor into this context (Individual Precondition). As these factors are difficult to sort from each other, they are presented together in this section. In the perception of the legal situation of physician-assisted suicide, the GPs’ assessments varied from “ illegal ” (GP3; GP11) to “ allowed under certain conditions ” (GP7). Their willingness to accommodate the request for physician-assisted suicide also varied from “ strict refusal ” (GP3; GP9; GP11) to “ providing information about alternative options ” (GP4) or to contact specific assisted dying associations (GP6). With a good and long doctor-patient-relationship, GPs were rather open to further measures: “ I think it would very much depend on whether I have accompanied the patient until then and have such a , already such a relationship , you know. […] Then I believe , I could imagine it more easily. ” (GP8). As inhibiting factors GPs cited personal values (GP3; GP9) and religious reasons: “ we as humans [are] not empowered to end a life , you know. Even if the person wants or wishes it .” (GP11). GPs also stated role conflict, as to them physician-assisted suicide conflicted with the professional role of a GP (GP8; GP10). A significant barrier was the legal uncertainty among GPs (GP6; GP9): “ And if the patient had then asked me to put an end to it , then […] I would actually have been afraid of losing my profession if I did something that is not currently allowed .” (GP10). However, the uncertainty also brought a temporarily relieving aspect: “ I’m actually glad that it’s not legally clarified yet because I can hide behind it. If it were clarified , I would have to deal with it .” (GP9).

Social relationships

Several participants emphasized the pivotal role of emotional and social support, especially in palliative care (GP2; GP3; GP7; GP9; GP10). A stable relationship with the patients is beneficial: “ knowing the entire […] environment of the patient. […] one can assess a bit where there are problems within the family or even in the household. […] So , I think that is an advantage that colleagues from other disciplines cannot have because they are not so on-site. And often , they don’t know the patients for as long .” (GP3). Conversely, palliative care poses a significant challenge when a stable relationship has not yet been established (GP2; GP7). The sense of security conveyed to patients with an established trust was seen as a factor that strengthens GPs in their work: “ Because I simply wanted to be there for my patients when they go. Because they have a bit more security there. After all , those were unfamiliar doctors [in the hospital]. […] when your own GP stands beside and essentially approves of what is happening , that’s something completely different. ” (GP10). When relatives or close individuals are involved in palliative care, the GPs must gain their trust as well (GP2; GP9). Gaining trust often requires (time-)intensive and emotionally charged conversations (GP5; GP6). Nevertheless, GPs considered involving relatives closely and early as an important aspect (GP9; GP11) as relatives can also reduce the workload for GPs by being guided, for example, in the administration of medications (GP11).

Societal conditions

The societal discourse surrounding the topic of mortality is perceived as challenging. Death is “ naturally tabooed in society ” (GP11) less so in the professional context (GP8). The societal taboo around deterred GPs from initiating these conversations (GP11). GPs even feared societal condemnation as “ involuntary angels of death ” (GP7) if they fulfill the requests for physician-assisted suicide. At the same time, there is a growing societal acknowledgment of palliative medical practices as supportive. Particularly, the gratitude expressed by those immediately affected was considered as “ justifying the effort ” (GP9).

Individual preconditions

Personal attitude.

Although palliative care is an inherent responsibility, death itself played a rather subordinate role in the everyday thoughts of the GPs surveyed. In the short survey, 72.7% stated that they do not think about the death of themselves, loved ones, or patients more than once a day (Table 2 ). There was also predominantly little fear of contact with death. Despite the GPs’ reservations about physician-assisted suicide, they understood patients’ desire for medical support about a self-determined death (GP6; GP7; GP10, Table 2 ). In the survey, six GPs agreed that everyone should have the freedom to decide for themselves how they want to die.

GPs found it challenging when patient or family preferences did not align with their assessment (GP8; GP11). This often occurred when family members sought maximum care, seen by GPs as an unnecessary burden.

Qualification

The majority of GPs (10 out of 11) felt emotionally prepared for the care of patients with palliative care needs. The level of experience in the sample was very heterogeneous. Some GPs ( n = 4) stated in the interview that they had not attended any further training. Mostly these GPs (but not exclusively) reported a lack of knowledge (GP8; GP11). For the other GPs, the further training varied between self-study ( n = 1), seminars ( n = 2) and additional training in palliative medicine ( n = 4). Despite GPs expressing a high level of clinical experience, they wanted more training, as palliative care “ is somewhat overlooked in training despite its elevated priority ” (GP3). The perceived lack of qualification increases the risk of a stress reaction. No predominant motivations for pursuing more extensive training could be discerned within the sample.

When assessing the GPs’ concerns about making mistakes in connection with palliative care, the overall mood was fairly balanced, with a slight tendency towards fear of making mistakes (Table 3 ).

There were discrepancies between the quantitative and qualitative data regarding communicative and psychosocial skills. In the quantitative data, the GPs predominantly expressed positivity regarding their communicative competencies. Specifically, 63.64% (n = 7) asserted competence in attentive listening to individuals in the terminal phase, and 72.73% (n = 8) expressed confidence in being able to have conversations with the dying. Communicating unfavorable prognoses presented only for 18.19% (n = 2) of GPs a specific challenge. However, in the interviews, GPs described a deficiency in training related to communication skills and offering psychological support to patients and their families (GP8; GP10; GP11) as “ no one teaches you how to conduct conversations“ (GP11).

GPs described palliative care as highly emotional. Some GPs mentioned that palliative care treatment pushes them to their emotional limits (GP9; GP11). Negative emotions described were a certain sense of discomfort, frustration, and helplessness (GP2; GP5; GP9; GP10). They perceived a younger age of patients and parenthood of younger children as emotionally more challenging (GP5; GP7; GP8). When they could identify themselves with the patients (e.g., through similar age or similar family situations), emotional involvement increased as the GPs were confronted by their own mortality (GP4; GP7; GP9). It is also challenging when patients or their families react defensively or deny the overall situation (GP5; GP6; GP11).

The lack of social support for the dying (e.g. during the COVID-19 pandemic) triggered negative emotions (GP11). GPs reported that the grief of the families or the fear of the patients also affects them (GP2). This is aggravated by a “feeling of guilt” if the care “simply did not go well and it could have been better ” (GP4).

However, palliative care can also evoke positive emotions, mostly described when patients are well-cared for in all four aspects of palliative medicine (physical, psychological, social, and spiritual). The social support provided by family members is particularly emphasized in this regard (GP2; GP10). GPs described gratitude from patients and family members, leading to a nonspecific positive feeling (GP6; GP7). In general, positive emotions were typically triggered when GPs felt they have achieved the best possible care for patients.

Dealing with stressors

Primary appraisal.

Some GPs rated palliative care as neither a positive nor a negative stimulus. If the external stimuli were assessed directly as “irrelevant”, active processing and dealing with any emotions was not necessary for the respective GPs. Some GPs appraised stimuli from palliative care activities as positive and enriching (GP3; GP6; GP7). In this case, no coping strategy was necessary as there was no negative stimulus to navigate. However, contrasting opinions also emerged, indicating that certain GPs regarded (parts of) palliative care as a potentially distressing stimulus, requiring coping strategies for the situation.

Secondary appraisal

The secondary evaluation occurs when a stimulus is initially perceived as potentially threatening. GPs identified high resilience and personal spirituality as protective elements for compensating for initially threatening stimuli (GP4; GP6; GP7; GP8; GP10). The interconnectedness of life and death was acknowledged, with the understanding that “ death [is] a part of our lives ” (GP6). This perspective helped them to cope with stressful situations. Addressing one’s mortality and thoughts about dying also facilitated communication with patients (GP4). Additionally, the importance of maintaining a good work-life balance was emphasized for the ability to accumulate and utilize sufficient personal resources (GP4; GP6). The GPs described a kind of emotional balancing. As positive emotions dominate in palliative care, they were able to compensate for the negative feelings (GP7).

If negative stressors cannot be sufficiently compensated for by protective factors, a coping mechanism becomes necessary. Problem-focused and emotion-focused coping strategies were evident in the GPs’ statements. However, a few of the GPs stated that they did not have a specific coping strategy.

Problem-focused coping

Some GPs described that they either proactively avoid situations that could lead to negative stressors or, at the very least, attempt to delegate a significant portion of the responsibility to other colleagues or external teams (such as SAPCT teams) (GP5; GP8, GP9). Another way to engage in problem-focused coping is through an organized work routine. Measures perceived as supportive include scheduling and incorporating buffer times (GP10) and conducting in-depth conversations to address the concerns of patients and their families. Establishing a 24-hour telephone availability for patients with palliative care needs and their families was discussed rather differently, either as supportive or as a further stressor (GP2; GP9). SAPCT teams were often cited as the primary source for both temporal and professional relief, especially as they are available 24 h a day (GP1; GP4; GP5; GP8; GP9; GP11). The lack of personal resources can thus be compensated for through interprofessional collaboration (GP5; GP7; GP9; GP11). Simultaneously, collaboration always involves an interface. Therefore, effective communication is essential, and its absence was otherwise perceived as a burden (GP7).

Emotion-focused coping

The spectrum of emotion-focused coping is diverse, individual methods range from practicing autogenic training (GP9) and engaging in sports (GP4) to having intensive conversations. Balint groups or colleagues in the practice were emphasized as helpful: “ One often discusses this with colleagues. I find that always super important , yes. […] That is actually the most effective coping measure for me .” (GP5). GPs only occasionally mentioned conversations with family and friends as a personal relief (GP7; GP8). Individual reflection and recapitulation of situations were also described as coping strategies (GP2; GP5). GPs mentally went through the treatment situations, evaluating where things went well and identifying areas for potential improvement. The consensus between the measures taken and the wishes and needs of the patients is particularly relieving in retrospect.

Occasionally, GPs kept their thoughts and emotions at a distance, leading to expressions like “to a certain extent , I don’t care” (GP1). For some, the distancing is the only way to fulfill the role as GP and to be able to handle the emotions of patients and their families.

ACP in primary care

Except for three GPs (GP1; GP3; GP7), the concept of ACP was unfamiliar to German GPs. The responses to ACP, however, were largely positive. Particularly, the initiation of discussions can be made easier by a structured program like ACP (GP2; GP9). Once the conversation has started, further discussions become easier: “ It’s like pushing a car. It requires a lot of effort to get it moving initially , but once it’s in motion , it’s relatively easy to push it a bit faster .” (GP9).

The GPs perceived the concept as more detailed and specific than an advance directive, yet they believed that it does not guarantee the discussion of the actual health conditions that may occur in advance (GP4). They emphasized the time problem again (GP11), making it impractical to offer ACP to all patients (GP8). The most frequently cited reason for individual relief for GPs was the existence of a specific action plan in the event that the respective patients become incapable of making decisions (GP2; GP6; GP7; GP8; GP10; GP11), especially in acute situations (GP8). GPs also mentioned personal protection against accusations from relatives (GP7). They evaluated ACP as emotionally challenging, especially when measures need to be withheld that are not in line with their preferences (GP1; GP8). Additionally, limited relief options were perceived when the treating GPs are not part of the advance planning process (GP1).

Main results

GPs regarded palliative care as an essential component of their work. They described significant challenges, with daily time constraints being the most prominent obstacle. There is a perceived lack of expertise in several aspects of palliative care. Despite difficulties, GPs expressed a commitment to enabling patients to die at home. Societal taboos often hindered discussions about death. Most GPs waited for their patients to initiate the topic. Implementing treatment limitations within palliative care was seen as a routine aspect. Their willingness to accommodate the request for physician-assisted suicide ranged from none to the willingness to take organizational measures regarding contact with assisted dying associations. Some GPs viewed aspects of palliative care as potentially distressing, requiring individual coping strategies. ACP was relatively unfamiliar among German GPs but was recognized as a valuable framework for discussing end-of-life care.

In context with other studies

GPs stated that palliative care is part of their job confirming previous studies [ 25 ]. Both, the number of services and the utilization of palliative care, have shown consistent growth in the last years in Germany [ 26 ]. Time constraints as the most prominent barrier [ 27 ] might be intensified by the increasing number of GPs who work part-time [ 28 ]. In alignment with our findings, other studies have also suggested that the work setting serves as a risk factor. For instance, working in a palliative care unit has been linked to a lower risk of burnout compared to working in mobile palliative care teams [ 29 ], nurses in specialized palliative care have reported higher levels of satisfaction compared to those in general palliative care [ 30 ].

Some GPs expressed fear of taking away hope and, consequently, quality of life when addressing death. However, studies have demonstrated that proactive care planning can improve quality of life [ 31 ]. In patients with metastatic cancer, discussing available care options and engaging in ACP resulted in improved emotional and mental quality of life [ 32 ]. Early discussion of the final stages of life and palliative care involvement could potentially extend survival time while improving the overall quality of life [ 33 ].

A lack of knowledge was mainly reported by younger GPs which was also found in other studies [ 25 , 27 ]. The participating GPs indicated that palliative care was neglected in their medical training. A review of educational curricula of medical schools in the United States identified a lack of incorporating palliative care into medical training [ 34 ]. Another study showed that despite the expansion of palliative care training programs, the evidence regarding their efficacy is poor [ 35 ]. In other studies, the impact of qualification levels on the perceived burden appeared to be minimal [ 36 ]. Nurses with higher qualifications experienced even higher levels of stress compared to those with lower qualifications [ 30 ]. The lack of knowledge may not necessarily impact the experience of stress. However, it could affect patient care as information deficits, fear, and uncertainty lead to more hospital admissions [ 37 ]. Declining end-of-life hospitalization in a medical advance care planning document can reduce the likelihood of hospitalization [ 38 ].

To some extent, GPs should display empathy in treatment situations. However, concerning their psychological well-being, there must be sufficient opportunities to acknowledge, perceive, and process these feelings. If this does not happen, distress can lead medical professionals to distance themselves more from patients or experience emotional numbness (compassion fatigue) [ 39 , 40 , 41 ]. Indicators of this could be identified in the interviews. Strategies against compassion fatigue, such as meditation programs can be helpful [ 42 , 43 ]. Additionally, the exchange between colleagues plays an important role in ensuring empathetic care [ 44 ]. A possible strategy to alleviate distress could be the so-called “Death Cafés“. This concept, where individuals casually exchange thoughts on death and related subjects over coffee and cake, has been previously offered, specifically for healthcare personnel as well [ 45 ].

The GPs believed that the most significant relief could be achieved when they engage in ACP conversations. In Germany, however, with training various medical professional groups can conduct ACP discussions [ 16 ]. Hence, there is a need for future discussions on how to involve GPs in this process so that they can benefit from potential relief.

Strengths and limitations of this study

The combination of both, survey and interviews, facilitated a more in-depth exploration of psychological stress experienced by GPs in their care of patients with palliative care needs. Combining two existing stress models Stress-Strain-Model [ 22 ] and Transactional Model of Stress and Coping [ 20 ] made it possible to link stressors and coping mechanisms and develop a theory-driven category system for data analysis.

We could not reach the number of participants as planned. Nevertheless, we assume that our heterogeneous sample led to a broad range of results and did not need to form any further new categories after eight interviews, indicating data saturation. The study may have predominantly included GPs with a particular interest in this topic (recruitment bias). The title, which referred to “psychological stress” may have contributed to the fact that not all GPs felt addressed. The focus of this research was psychological stress in the context of external and internal factors. We did not look at stress as a biological factor. Some of the GPs classified the stimuli arising from palliative care as “irrelevant”. This may already represent a protective mechanism for the GPs. An exact differentiation between “irrelevant” and protective mechanisms was not possible based on the interviews. Furthermore, we assumed that ACP is unknown among GPs which may have influenced the results.

Palliative care can be associated with negative psychological stress for GPs. However, the actual work with patients with palliative care needs is not always the challenging aspect; often, the challenging issues arise from the surrounding conditions, such as inadequate billing options, time constraints, or uncertainties regarding legal matters. Despite individual coping strategies already in place, it is advisable to explore concepts for professional psychological relief. It is crucial to increase awareness of ACP’s existence and offer training opportunities. A clearer legal framework must be created and communicated to GPs in an easily accessible manner by the legislator.

Data availability

The full datasets used and analysed are available from the corresponding author upon reasonable request.

Abbreviations

Advance Care Planning

General Practitioner

Specialized Ambulatory Palliative Care Teams

Radbruch L, De Lima L, Knaul F, Wenk R, Ali Z, Bhatnaghar S, Blanchard C, Bruera E, Buitrago R, Burla C, et al. Redefining Palliative Care-A New Consensus-based definition. J Pain Symptom Manage. 2020;60(4):754–64.

Article PubMed PubMed Central Google Scholar

Krause M, Ditscheid B, Lehmann T, Jansky M, Marschall U, Meißner W, Nauck F, Wedding U, Freytag A. Effectiveness of two types of palliative home care in cancer and non-cancer patients: a retrospective population-based study using claims data. Palliat Med. 2021;35(6):1158–69.

Murtagh FE, Bausewein C, Verne J, Groeneveld EI, Kaloki YE, Higginson IJ. How many people need palliative care? A study developing and comparing methods for population-based estimates. Palliat Med. 2014;28(1):49–58.

Article PubMed Google Scholar

Palliative care. https://www.who.int/news-room/fact-sheets/detail/palliative-care .

Faktencheck Palliativversorgung [Fact Check Palliative. Care] [ https://faktencheck-gesundheit.de/de/faktenchecks/faktencheck-palliativversorgung/ergebnis-ueberblick/ ].

Palliativversorgung: Strukturen und regionale Unterschiede in der Hospiz- und Palliativversorgung [Structures and Regional Disparities in Hospice and Palliative Care Services]. https://faktencheck-gesundheit.de/fileadmin/files/BSt/Publikationen/GrauePublikationen/Studie_VV__FCG_Versorgungsstrukturen-palliativ.pdf .

Bayerische Landesärztekammer [Bavarian State Chamber of Physicians]. Weiterbildungsordnung für die Ärzte Bayerns [The Education regulations for Physicians in Bavaria]. In.; 2021.

Geiger K, Schneider N, Bleidorn J, Klindtworth K, Jünger S, Müller-Mundt G. Caring for frail older people in the last phase of life - the general practitioners’ view. BMC Palliat care. 2016;15:52.

Silveira MJ, Forman J. End-of-life care from the perspective of primary care providers. J Gen Intern Med. 2012;27(10):1287–93.

Kelly B, Varghese FT, Burnett P, Turner J, Robertson M, Kelly P, Mitchell G, Treston P. General practitioners’ experiences of the psychological aspects in the care of a dying patient. Palliat Support Care. 2008;6(2):125–31.

Kelly B, Handley T, Kissane D, Vamos M, Attia J. An indelible mark the response to participation in euthanasia and physician-assisted suicide among doctors: a review of research findings. Palliat Support Care. 2020;18(1):82–8.

Dobscha SK, Heintz RT, Press N, Ganzini L. Oregon physicians’ responses to requests for assisted suicide: a qualitative study. J Palliat Med. 2004;7(3):451–61.

Schnakenberg R, Radbruch L, Kersting C, Frank F, Wilm S, Becka D, Weckbecker K, Bleckwenn M, Just JM, Pentzek M, et al. More counselling for end-of-life decisions by GPs with own advance directives: a postal survey among German general practitioners. Eur J Gen Pract. 2018;24(1):131–7.

Sudore RL, Lum HD, You JJ, Hanson LC, Meier DE, Pantilat SZ, Matlock DD, Rietjens JAC, Korfage IJ, Ritchie CS, et al. Defining Advance Care planning for adults: a Consensus Definition from a Multidisciplinary Delphi Panel. J Pain Symptom Manage. 2017;53(5):821–e832821.

Götze K, Feddersen B, In der Schmitten J, Marckmann G. Advance Care Planning in Germany. Z Evid Fortbild Qual Gesundhwes. 2023;180:127–32.

Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014;28(8):1000–25.

Bundesärztekammer [German Medical Association]. Hinweise Der Bundesärztekammer Zum ärztlichen Umgang Mit Suizidalität Und Todeswünschen Nach dem Urteil Des Bundesverfassungsgerichts zu § 217 StGB [Guidelines from the German Medical Association on the medical handling of suicidality and death wishes following the ruling of the Federal Constitutional Court on § 217 of the German criminal code]. Deutsches Ärzteblatt. 2021;118(29–30):1428–32.

Google Scholar

Soler JK, Yaman H, Esteva M, Dobbs F, Asenova RS, Katic M, Ozvacic Z, Desgranges JP, Moreau A, Lionis C, et al. Burnout in European family doctors: the EGPRN study. Fam Pract. 2008;25(4):245–65.

Schernhammer ES, Colditz GA. Suicide rates among physicians: a quantitative and gender assessment (meta-analysis). Am J Psychiatry. 2004;161(12):2295–302.

Lazarus RS. Stress, appraisal, and coping. New York: Springer Publishing Company; 1984.

Klug A. FESTD - Fragebogen zu Einstellungen zu Sterben, Tod und Danach [Questionnaire on attitudes towards dying, death, and beyond]. 2007.

Rohmert W. Das Belastungs-Beanspruchungs-Konzept [The stress-and-Strain-Modell]. Z für Arbeitswissenschaften. 1984;4(38):193–200.

Kuckartz U, Rädiker S. Qualitative inhaltsanalyse. Methoden, Praxis, Computerunterstützung [Qualitative content analysis: methods, practice, computer assistance]. 5 ed. Weinheim: Juventa Verlag, Imprint of Julius Beltz GmbH & Co. KG; 2022.

Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57.

Peter S, Volkert AM, Pfaff H, Radbruch L, Rolke R, Voltz R, Scholten N. General practitioners’ perspectives on General and Specialized Palliative Home Care in North Rhine, Germany: an Explorative Focus Group Study. Am J Hosp Palliat Care. 2021;38(1):32–8.

Prütz F, Saß A-C. Daten Zur Palliativversorgung in Deutschland: Welche Datenquellen gibt es, und was sagen sie aus? [Data on palliative care in Germany: what data sources are available, and what do they reveal?]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017;60(1):26–36.

Carey ML, Zucca AC, Freund MA, Bryant J, Herrmann A, Roberts BJ. Systematic review of barriers and enablers to the delivery of palliative care by primary care practitioners. Palliat Med. 2019;33(9):1131–45.

Bedarf an Ärzten. nach wie vor groß – Trend zu Teilzeit und Anstellung ungebrochen [Demand for Physicians Still High – Trend Towards Part-Time and Employment Continues Unabated] [ https://www.kbv.de/html/2021_51564.php ].

Dréano-Hartz S, Rhondali W, Ledoux M, Ruer M, Berthiller J, Schott AM, Monsarrat L, Filbet M. Burnout among physicians in palliative care: impact of clinical settings. Palliat Support Care. 2016;14(4):402–10.

Diehl E, Rieger S, Letzel S, Schablon A, Nienhaus A, Escobar Pinzon LC, Dietz P. Burdens, resources, health and wellbeing of nurses working in general and specialised palliative care in Germany - results of a nationwide cross-sectional survey study. BMC Nurs. 2021;20(1):162.

Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009;302(7):741–9.

Article CAS PubMed PubMed Central Google Scholar

Dyar S, Lesperance M, Shannon R, Sloan J, Colon-Otero G. A nurse practitioner directed intervention improves the quality of life of patients with metastatic cancer: results of a randomized pilot study. J Palliat Med. 2012;15(8):890–5.

Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363(8):733–42.

Article CAS PubMed Google Scholar

Horowitz R, Gramling R, Quill T. Palliative care education in U.S. medical schools. Med Educ. 2014;48(1):59–66.

Brighton LJ, Koffman J, Hawkins A, McDonald C, O’Brien S, Robinson V, Khan SA, George R, Higginson IJ, Selman LE. A systematic review of end-of-Life Care Communication skills Training for Generalist Palliative Care providers: Research Quality and Reporting Guidance. J Pain Symptom Manage. 2017;54(3):417–25.

Peter S, Volkert AM, Radbruch L, Rolke R, Voltz R, Pfaff H, Scholten N. Influence of Palliative Care qualifications on the job stress factors of General practitioners in Palliative Care: a Survey Study. Int J Environ Res Public Health 2022, 19(21).

Albisser Schleger H, Pargger H, Reiter-Theil S. „Futility - Übertherapie am Lebensende? Gründe für ausbleibende Therapiebegrenzung in Geriatrie Und Intensivmedizin [Futility - overtreatment at the end of life? Reasons for the lack of therapy limitation in geriatrics and intensive care medicine]. Z für Palliativmedizin. 2008;9(2):67–75.

Article Google Scholar

Honinx E, Piers RD, Onwuteaka-Philipsen BD, Payne S, Szczerbińska K, Gambassi G, Kylänen M, Deliens L, van den Block L, Smets T. Hospitalisation in the last month of life and in-hospital death of nursing home residents: a cross-sectional analysis of six European countries. BMJ open. 2021;11(8):e047086.

Melvin CS. Professional compassion fatigue: what is the true cost of nurses caring for the dying? Int J Palliat Nurs. 2012;18(12):606–11.

Kleiner S, Wallace JE. Oncologist burnout and compassion fatigue: investigating time pressure at work as a predictor and the mediating role of work-family conflict. BMC Health Serv Res. 2017;17(1):639.

Salmond E, Salmond S, Ames M, Kamienski M, Holly C. Experiences of compassion fatigue in direct care nurses: a qualitative systematic review. JBI Database Syst Reviews Implement Rep. 2019;17(5):682–753.

Baqeas MH, Davis J, Copnell B. Compassion fatigue and compassion satisfaction among palliative care health providers: a scoping review. BMC Palliat care. 2021;20(1):88.

Hill RC, Dempster M, Donnelly M, McCorry NK. Improving the wellbeing of staff who work in palliative care settings: a systematic review of psychosocial interventions. Palliat Med. 2016;30(9):825–33.

Bessen S, Jain RH, Brooks WB, Mishra M. Sharing in hopes and worries-a qualitative analysis of the delivery of compassionate care in palliative care and oncology at end of life. Int J Qualitative Stud Health well-being. 2019;14(1):1622355.

Hammer R, Ravindran N, Nielsen N. Can Death Cafés resuscitate morale in hospitals? Med Humanit. 2021;47(1):2–3.

Download references

Acknowledgements

We want to thank the GPs who consented to participate in the study.

Open Access funding enabled and organized by Projekt DEAL. We acknowledge financial support by Deutsche Forschungsgemeinschaft and Friedrich-Alexander-Universität Erlangen-Nürnberg within the funding program “Open Access Publication Funding”.

Open Access funding enabled and organized by Projekt DEAL.

Author information

Authors and affiliations.

Institute of General Practice, Friedrich-Alexander-University Erlangen-Nürnberg, University Hospital Erlangen, Universitätsstr. 29, 91054, Erlangen, Germany

Verena Lopez, Piet van der Keylen, Thomas Kühlein & Maria Sebastião

Lutheran University of Applied Sciences, Nürnberg, Germany

Piet van der Keylen

You can also search for this author in PubMed Google Scholar

Contributions

VL, PvK and MS designed the study. VL conducted the interviews. VL, PvK, TK, and MS contributed to the data analysis and interpretation of the data. VL was the primary contributor in writing the manuscript, with major contributions from MS. All authors reviewed and approved the final manuscript. The present work was performed in (partial) fulfillment of the requirements for obtaining the degree “Dr. med.” for VL at the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU).

Corresponding author

Correspondence to Maria Sebastião .

Ethics declarations

Ethics approval and consent to participate.

Ethics approval was obtained from the ethics committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg (file number 21-377-B). Before the commencement, written informed consent was obtained from the participants. All methods were carried out in accordance with relevant guidelines, and regulations, and with the ethical principles of the Declaration of Helsinki.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Authors’ information

The present work was performed in (partial) fulfillment of the requirements for obtaining the degree “Dr. med.” for VL at the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU).

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary Material 1

Rights and permissions.

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Cite this article.

Lopez, V., van der Keylen, P., Kühlein, T. et al. Psychological stress of general practitioners in the care of patients with palliative care needs: an exploratory study. BMC Palliat Care 23 , 197 (2024). https://doi.org/10.1186/s12904-024-01529-w

Download citation

Received : 26 March 2024

Accepted : 23 July 2024

Published : 03 August 2024

DOI : https://doi.org/10.1186/s12904-024-01529-w

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Palliative care
General practitioner
Coping mechanism
Advance care planning

BMC Palliative Care

ISSN: 1472-684X

Submission enquiries: [email protected]
General enquiries: [email protected]

Environment
Science & Technology
Business & Industry
Health & Public Welfare
Topics (CFR Indexing Terms)

Public Inspection

Presidential Documents
Document Search
Advanced Document Search
Public Inspection Search
Reader Aids Home
Office of the Federal Register Announcements
Using FederalRegister.Gov
Understanding the Federal Register
Recent Site Updates
Federal Register & CFR Statistics
Videos & Tutorials
Developer Resources
Government Policy and OFR Procedures
Congressional Review
My Clipboard
My Comments
My Subscriptions
Sign In / Sign Up
Site Feedback
Search the Federal Register

The Federal Register

The daily journal of the united states government, legal status.

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.

Proposed Rule

Medicare and medicaid programs; cy 2025 payment policies under the physician fee schedule and other changes to part b payment and coverage policies; medicare shared savings program requirements; medicare prescription drug inflation rebate program; and medicare overpayments.

A Proposed Rule by the Centers for Medicare & Medicaid Services on 07/31/2024

This document has a comment period that ends in 37 days. (09/09/2024) Submit a formal comment

Thank you for taking the time to create a comment. Your input is important.

Once you have filled in the required fields below you can preview and/or submit your comment to the Health and Human Services Department for review. All comments are considered public and will be posted online once the Health and Human Services Department has reviewed them.

You can view alternative ways to comment or you may also comment via Regulations.gov at https://www.regulations.gov/commenton/CMS-2024-0256-0045 .

What is your comment about?

Note: You can attach your comment as a file and/or attach supporting documents to your comment. Attachment Requirements .

this will NOT be posted on regulations.gov

Opt to receive email confirmation of submission and tracking number?
Tell us about yourself! I am... *
First Name *
Last Name *
State Alabama Alaska American Samoa Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Guam Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virgin Islands Virginia Washington West Virginia Wisconsin Wyoming
Country Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Côte d'Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People's Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macao Macedonia, the Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia, Federated States of Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Viet Nam Virgin Islands, British Virgin Islands, U.S. Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe
Organization Type * Company Organization Federal State Local Tribal Regional Foreign U.S. House of Representatives U.S. Senate
Organization Name *
You are filing a document into an official docket. Any personal information included in your comment text and/or uploaded attachment(s) may be publicly viewable on the web.
I read and understand the statement above.
Preview Comment

Document Details

Information about this document as published in the Federal Register .

Document Statistics

Enhanced content.

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register . Use the PDF linked in the document sidebar for the official electronic format.

Enhanced Content - Table of Contents

This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect.

FOR FURTHER INFORMATION CONTACT:

Supplementary information:, i. executive summary, b. summary of the major provisions, c. summary of costs and benefits, ii. provisions of the proposed rule for the pfs, a. background, b. determination of pe rvus, 1. overview, 2. practice expense methodology, a. direct practice expense, b. indirect practice expense per hour data, c. allocation of pe to services, (1) direct costs, (2) indirect costs, (3) facility and nonfacility costs, (4) services with technical components and professional components, (5) pe rvu methodology, (a) setup file, (b) calculate the direct cost pe rvus, (c) create the indirect cost pe rvus, (d) calculate the final pe rvus, (e) setup file information, (6) equipment cost per minute, 3. adjusting rvus to match the pe share of the medicare economic index (mei), 4. changes to direct pe inputs for specific services, a. standardization of clinical labor tasks, b. updates to prices for existing direct pe inputs, (1) invoice submission, (2) supply pack pricing update, c. clinical labor pricing update, 5. development of strategies for updates to practice expense data collection and methodology, a. background, b. preparation for incorporating refreshed data and request for information on timing to effectuate routine updates, c. potentially misvalued services under the pfs, 1. background, 2. progress in identifying and reviewing potentially misvalued codes, 3. cy 2025 identification and review of potentially misvalued services, a. public nominations, (1) cpt codes 22210, 22212, 22214, 22216, (2) cpt code 27279, (3) cpt code 95800, (4) cpt codes 10021, 10004, 10005, 10006, (5) tympanostomy codes, d. payment for medicare telehealth services under section 1834(m) of the act, 1. payment for medicare telehealth services under section 1834(m) of the act, a. changes to the medicare telehealth services list, b. requests to add services to the medicare telehealth services list for cy 2025, (1) continuous glucose monitoring, (2) cardiovascular and pulmonary rehabilitation, (3) health and well being-coaching, (4) psychological testing and developmental testing, (5) therapy/audiology/speech language pathology, (6) care management, (7) posterior tibial nerve stimulation for voiding dysfunction, (8) radiation treatment management, (9) home international normalized ratio (inr) monitoring, (10) caregiver training, c. other services proposed for addition to the medicare telehealth services list, (1) preexposure prophylaxis (prep) of human immunodeficiency virus (hiv), d. frequency limitations on medicare telehealth subsequent care services in inpatient and nursing facility settings, and critical care consultations, 1. subsequent inpatient visit cpt codes, 2. subsequent nursing facility visit cpt codes, 3. critical care consultation services: hcpcs codes, e. audio-only communication technology to meet the definition of “telecommunications system”, f. distant site requirements, 2. other non-face-to-face services involving communications technology under the pfs, a. direct supervision via use of two-way audio/video communications technology, (1) proposal to extend definition of “direct supervision” to include audio-video communications technology through 2025, (2) proposal to permanently define “direct supervision” to include audio-video communications technology for a subset of services, (3) teaching physician billing for services involving residents with virtual presence, (a) request for information for teaching physician services furnished under the primary care exception, 3. telehealth originating site facility fee payment amount update, 4. payment for outpatient therapy services, diabetes self-management training, and medical nutrition therapy when furnished by institutional staff to beneficiaries in their homes through communication technology, e. valuation of specific codes, 1. background: process for valuing new, revised, and potentially misvalued codes, 2. methodology for establishing work rvus, 3. methodology for the direct pe inputs to develop pe rvus, b. common refinements, (1) changes in work time, (2) equipment time, (3) standard tasks and minutes for clinical labor tasks, (4) recommended items that are not direct pe inputs, (5) new supply and equipment items, (6) service period clinical labor time in the facility setting, (7) procedures subject to the multiple procedure payment reduction (mppr) and the opps cap, 4. valuation of specific codes for cy 2025, (1) skin cell suspension autograft (cpt codes 15xx1, 15xx2, 15xx3, 15xx4, 15xx5, 15xx6, 15xx7, and 15xx8), (2) hand, wrist, & forearm repair & recon (cpt codes 25310, 25447, 2x005, and 26480), (3) car-t therapy services (cpt codes 3x018, 3x019, 3x020, and 3x021), (4) therapeutic apheresis and photopheresis (cpt codes 36514, 36516, and 36522), (5) intra-abdominal tumor excision or destruction (cpt codes 4x015, 4x016, 4x017, 4x018, and 4x019), (6) bladder neck and prostate procedures (cpt codes 5xx05 and 5xx06), (7) mri-monitored transurethral ultrasound ablation of prostate (cpt codes 5x006, 5x007, and 5x008), (8) insertion of cervical dilator (cpt code 59200), (9) guided high intensity focused ultrasound (cpt code 6xx00), (10) percutaneous radiofrequency ablation of thyroid (cpt codes 6xx01 and 6xx02), (11) fascial plane blocks (cpt codes 6xx07, 6xx08, 6xx09, 6xx10, 6xx11, 6xx12, 64486, 64487, 64488, and 64489), (12) skin adhesives (cpt codes 64590 and 64595 and hcpcs codes g0168, g0516, g0517, and g0518), (13) iris procedures (cpt codes 66680, 66682, and 6x004), (14) magnetic resonance examination safety procedures (cpt codes 7xx00, 7xx01, 7xx02, 7xx03, 7xx04, and 7xx05), (15) screening virtual colonoscopy (cpt code 74263), (16) ultrasound elastography (cpt codes 76981, 76982, and 76983), (17) ct guidance needle placement (cpt code 77012), (18) telemedicine evaluation and management (e/m) services (cpt codes 9x075, 9x076, 9x077, 9x078, 9x079, 9x080, 9x081, 9x082, 9x083, 9x084, 9x085, 9x086, 9x087, 9x088, 9x089, 9x090, and 9x091), (19) genetic counseling services (cpt code 9x100), (20) covid immunization administration (cpt code 90480), (21) optical coherence tomography (cpt codes 92132, 92133, 92134, and 9x059), (22) transcranial doppler studies (cpt codes 93886, 93888, 93892, 93893, 93x94, 93x95, 93x96, and 93890), (23) rsv monoclonal antibody administration (cpt codes 96380 and 96381), (24) hyperthermic intraperitoneal chemotherapy (cpt codes 96547 and 96548), (25) laser treatment—skin (cpt codes 96920, 96921, and 96922), (26) physical medicine and rehabilitation (cpt codes 97012, 97014, 97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537, and 97542 and hcpcs code g0283), (27) acupuncture—electroacupuncture (cpt codes 97810, 97811, 97813, and 97814), (28) annual alcohol screening (hcpcs codes g0442 and g0443), (29) annual depression screening (hcpcs code g0444), (30) behavioral counseling & therapy (hcpcs codes g0445, g0446, and g0447), (31) autologous platelet rich plasma (hcpcs code g0465), (32) temporary female intraurethral valve-pump (cpt codes 0596t and 0597t), (33) pe-only replacement code for heart failure system, (34) portable x-ray (hcpcs codes r0070-r0075), (35) non-chemotherapy administration, (36) hospital inpatient or observation (i/o) evaluation and management (e/m) add-on for infectious diseases (hcpcs code gidxx), 1. disease transmission risk assessment and mitigation, 2. public health investigation, analysis, and testing, 3. complex antimicrobial therapy counseling & treatment, (37) preexposure prophylaxis (prep) of human immunodeficiency virus (hiv), (38) opfolda, (39) payment for caregiver training services, b. caregiver assessment, c. proposals and new coding, (a) proposed direct care caregiver training services, ii. valuation, (b) individual behavior management/modification caregiver training services, (c) patient consent, (d) addition to telehealth list, b. request for information on services addressing health-related social needs, f. evaluation and management (e/m) visits, 1. office/outpatient (o/o) evaluation and management (e/m) visit complexity add-on, g. enhanced care management, 2. advanced primary care management (apcm) services (hcpcs codes gpcm1, gpcm2, and gpcm3), (1) key care delivery methods in select cms innovation center models, b. proposed hcpcs g-codes for advanced primary care management (apcm), (1) level 1 apcm, (2) level 2 apcm, (3) level 3 apcm, c. apcm service elements and practice-level capabilities, (1) beneficiary consent, (2) initiating visit, (3) 24/7 access and continuity of care, (4) comprehensive care management, (5) patient-centered comprehensive care plan, (6) management of care transitions, (7) practitioner, home-, and community-based care coordination, (8) enhanced communications opportunities, (9) patient population-level management, (10) performance measurement, d. duplicative services and concurrent billing restrictions, e. valuation of apcm services—gpcm1, gpcm2, and gpcm3, 3. request for information: advanced primary care hybrid payment, b. solicitation of public comments, (1) streamlined value-based care opportunities, (2) billing requirements, (3) person-centered care, (4) health equity, social and clinical risk, (5) quality improvement and accountability, 4. cardiovascular risk assessment and risk management, b. ascvd risk assessment, (1) proposed valuation for ascvd risk assessment gcdra, c. atherosclerotic cardiovascular disease risk management services (gcdrm), (1) proposed valuation for ascvd risk management services (gcdrm), 5. strategies for improving global surgery payment accuracy, b. clarifying the scope of global surgical packages, c. strategies to address global package valuation, d. expand applicability of transfer of care modifiers, e. payment for global packages, f. post-operative care services add-on code, g. proposed valuation for gpoc1 add-on code, h. supervision of outpatient therapy services in private practices, certification of therapy plans of care with a physician or npp order, and kx modifier thresholds, 1. supervision of outpatient therapy services in private practices, 2. certification of therapy plans of care with a physician or npp order, 3. kx modifier thresholds, i. advancing access to behavioral health services, 1. safety planning interventions and post-discharge telephonic follow-up contacts, b. safety planning interventions (spi), c. post-discharge telephonic follow-up contacts intervention (fci), 2. digital mental health treatment (dmht), b. payment for digital mental health treatment (dmht) devices, 3. interprofessional consultation billed by practitioners authorized by statute to treat behavioral health conditions, c. valuation, 4. comment solicitation on payment for services furnished in additional settings, including freestanding sud treatment facilities, crisis stabilization units, urgent care centers, and certified community behavioral health clinics (ccbhcs), j. proposals on medicare parts a and b payment for dental services inextricably linked to specific covered services, 1. medicare payment for dental services, a. overview, b. consideration of dental services that may be inextricably linked to other covered services, 1. consideration of dental services that may be inextricably linked to covered services for the treatment of sickle cell disease, 2. consideration of dental services that may be inextricably linked to covered services for the treatment of hemophilia, c. submissions received through public submission process, 2. proposed additions to current policies permitting payment for dental services inextricably linked to other covered services, 3. request for comment on dental services integral to specific covered services to treat diabetes, 4. request for comment on dental services integral to specific covered services to treat systemic autoimmune disease requiring immunosuppressive therapies, 5. implementation of payment for dental services inextricably linked to other specific covered services, 6. request for information: services associated with furnishing oral appliances used for the treatment of obstructive sleep apnea, k. payment for skin substitutes, iii. other provisions of the proposed rule, a. drugs and biological products paid under medicare part b, 1. requiring manufacturers of certain single-dose container or single-use package drugs to provide refunds with respect to discarded amounts (§§ 414.902 and 414.940), b. application for increased applicable percentage, c. clarifications for the definition of refundable single-dose container or single-use package drug, (1) exclusions for drugs for which payment has been made under part b for fewer than 18 months, (2) clarification for identifying single-dose containers, (3) skin substitutes, d. discarded amounts, 2. payment limit calculation when manufacturers report negative or zero average sales price (asp) data (§ 414.904), b. approach to payment limit calculations when manufacturer's asp data is not available, c. single and multiple source drugs when negative or zero manufacturer's asp data is reported for some, but not all ndcs, d. multiple source drugs with only negative or zero manufacturer's asp data, e. single source drugs with only negative or zero manufacturer's asp data, excluding biosimilar biological products, f. biosimilars with only negative or zero manufacturer's asp data, g. discontinued drugs, 3. payment of radiopharmaceuticals in the physician office, 4. immunosuppressive therapy (§§ 410.30 and 414.1001), b. compounded immunosuppressive drugs with oral or enteral routes of administration, c. immunosuppressive refill policy and supplying fee, 5. blood clotting factors (§ 410.63), b. rural health clinics (rhcs) and federally qualified health centers (fqhcs), 1. background on rhc and fqhc payment methodologies, 2. general care management services in rhcs and fqhcs, b. proposed regulatory update (§ 405.2464(c)), c. proposed payment policy for general care management services, d. new codes for advanced primary care management (apcm) services, e. request for information—aligning with services paid under the pfs, 3. telecommunication services, b. direct supervision via use of two-way audio/video communications technology, (1) proposal for cy 2025, c. telecommunications technology, (1) payment proposal for non-behavioral health telecommunication technology services, (2) alternative proposal considered for payment of medical visits furnished via telecommunication technology, d. in-person visit requirements for remote mental health services furnished by rhc and fqhcs, 4. intensive outpatient program services (iop), b. update to special payment rules for intensive outpatient services, c. technical correction (§§ 405.2410 and 405.2462), 5. payment for preventive vaccine costs in rhcs and fqhcs, b. revisions to current policy, 6. productivity standards, 7. proposed rebasing of the fqhc market basket, b. overview of the proposed 2022-based fqhc market basket, c. development of the proposed 2022-based fqhc market basket cost categories and weights, (1) use of medicare cost report data, (a) fqhc practitioner wages and salaries costs, (b) fqhc practitioner employee benefits costs, (c) fqhc practitioner contract labor costs, (d) clinical staff wages and salaries costs, (e) clinical staff employee benefits costs, (f) clinical staff contract labor costs, (g) non-health staff compensation costs, (h) pharmaceutical costs, (i) medical supplies costs, (j) fixed assets costs, (k) movable equipment costs, (2) proposed major cost category computation, (3) derivation of the detailed operating cost weights, (4) proposed 2022-based fqhc market basket cost categories and weights, d. selection of price proxies, (1) price proxies for the proposed 2022-based fqhc market basket, (a) fqhc practitioner wages and salaries, (b) fqhc practitioner employee benefits, (c) clinical staff wages and salaries, (d) clinical staff employee benefits, (e) non-health staff compensation, (f) pharmaceuticals, (g) utilities, (h) medical equipment, (i) medical supplies, (j) miscellaneous products, (k) professional, scientific, and technical services, (l) administrative and facilities support services, (m) all other services, (n) fixed assets, (o) movable equipment, (2) summary of price proxies of the proposed 2022-based fqhc market basket, e. proposed cy 2025 productivity-adjusted market basket update for fqhcs, 8. clarification for dental services furnished in fqhcs, a. payment for dental services furnished in fqhcs, b. medical and dental visits furnished on the same day, 9. “grandfathered” technical refinement, b. technical refinement, c. rural health clinic (rhc) and federally qualified health center (fqhc) conditions for certification and conditions for coverage (cfcs), 1. background and statutory authority, 2. proposed changes to the rhc and fqhc conditions for certification and conditions for coverage (cfcs), a. provision of services ( 42 cfr 491.9 ), d. clinical laboratory fee schedule: revised data reporting period and phase-in of payment reductions, 1. background on the clinical laboratory fee schedule, 2. payment requirements for clinical diagnostic laboratory tests, 3. previous statutory revisions to the data reporting period and phase-in of payment reductions, 4. additional statutory revisions to the data reporting period and phase-in of payment reductions, 5. proposed conforming regulatory changes, e. medicare diabetes prevention program (mdpp), 1. proposed changes to § 410.79 by amending paragraphs (b) and (d)(1), 2. proposed changes to § 410.79(e)(3)(iii), 3. proposed changes to § 414.84(a), (c), (d), and (e), 4. aligning language with previous rulemaking in §§ 410.79, 424.205, and 414.84, f. modifications related to medicare coverage for opioid use disorder (oud) treatment services furnished by opioid treatment programs (otps), 2. telecommunication flexibilities for periodic assessments and initiation of treatment with methadone, a. proposal to allow periodic assessments to be furnished via audio-only telecommunications on a permanent basis, b. proposal to allow otps to use audio-visual telecommunications for initiation of treatment with methadone, 3. proposals related to reforms to 42 cfr part 8, a. proposal to establish payment for social determinants of health risk assessments, b. request for information on payment for coordinated care and referrals to community-based organizations that address unmet health-related social needs, provide harm reduction services, and/or provide recovery support services, 4. establishing payment for new fda-approved opioid agonist and antagonist medications, a. coding and payment for a new nalmefene hydrochloride product, opvee®, b. coding and payment for new injectable buprenorphine product brixadi®, 5. clarification to require an opioid use disorder diagnosis on claims for oud treatment services, g. medicare shared savings program, 1. executive summary and background, b. statutory and regulatory background on the shared savings program, c. summary of shared savings program proposals, 2. eligibility requirements and application procedures, b. monitoring compliance with the requirement that acos maintain at least 5,000 assigned beneficiaries, c. update antitrust language, 3. beneficiary assignment methodology, a. proposed revisions to the definition of primary care services, (1) background, (2) proposed revisions, b. proposed revisions to criteria for aco models to waive shared savings program statutory requirements giving precedence for assignment based on beneficiary voluntary alignment, 4. quality performance standard & other reporting requirements, b. proposal to require shared savings program acos to report the alternative payment model (apm) performance pathway (app) plus quality measure set, (a) proposal to require shared savings program acos to report the app plus quality measure set, (b) proposed collection types available for shared savings program acos reporting the app plus quality measure set, (3) proposed changes to regulation text, c. proposed changes to the methodology for calculating the mips quality performance category score for shared savings program acos reporting the app plus quality measure set, (a) proposal to establish the data submission criteria for the app plus quality measure set, (b) proposal to establish a complex organization adjustment for virtual groups and apm entities, (c) proposal to score shared savings program acos reporting medicare cqms using flat benchmarks, d. proposal to extend the ecqm reporting incentive for meeting the shared savings program quality performance standard, e. summary of proposals, f. proposed app plus quality measure set, g. survey modes for the administration of the consumer assessment of healthcare providers and systems (cahps) for mips survey request for information, 5. providing the option of prepaid shared savings, b. eligibility, c. application procedure & contents, d. allowable and prohibited uses of prepaid shared savings, e. calculation of prepaid shared savings, f. duration, frequency and withholding or termination of prepaid shared savings payments, (1) duration and frequency, (2) withholding and termination, g. monitoring aco eligibility for and use of prepaid shared savings, h. recoupment of prepaid shared savings, i. oig safe harbor authority, 6. advance investment payment policies, a. proposal to allow acos receiving advance investment payments to voluntarily terminate payments while continuing participation in the shared savings program, b. proposal to recoup advance investment payments when cms terminates the participation agreement of an aco, 7. financial methodology, b. health equity benchmark adjustment, (a) summary of statutory and regulatory background on adjusting the historical benchmark, (b) methodology for determining the applicability of a regional adjustment or prior savings adjustment to the aco's historical benchmark, for agreement periods beginning on or after january 1, 2024, (c) background on incorporating health equity data within the shared savings program, c. reopening aco payment determinations, (a) statutory background on shared savings program financial calculations, (b) background on shared savings program reopening policy and financial calculation methodology, (a) proposed change to provision specifying cms' discretion to reopen payment determinations, (b) considerations for reopening a payment determination to account for improper payments, (c) methodology for recalculating expenditures to account for improper payments, (d) adjusting historical benchmarks to account for the impact of improper payments, (e) aco reopening requests, (f) preventing and reporting medicare fraud, d. mitigating the impact of significant, anomalous, and highly suspect billing activity on shared savings program financial calculations in calendar year 2024 or subsequent calendar years, (b) background on significant, anomalous, and highly suspect billing activity, (a) identifying significant, anomalous, and highly suspect billing activity, (b) adjustments to shared savings program calculations, e. seeking comment on establishing higher risk and potential reward under the enhanced track, (a) current enhanced track, (b) other cms innovation center models, (2) considerations for incorporating higher risk and potential reward under the enhanced track, (a) benchmark discount rate, (b) tapered sharing arrangements, (c) msr/mlr, (d) cap on regional adjustment weight, (e) payment mechanisms, f. proposed technical change for consistency in financial calculations, 8. beneficiary notification requirements, a. proposal to modify the requirements for when acos must provide the beneficiary information follow-up communication, b. limit the distribution of the beneficiary notification to beneficiaries likely to be assigned for acos under preliminary prospective assignment with retrospective reconciliation, h. medicare part b payment for preventive services (§§ 410.10, 410.57, 410.64, 410.152), 1. part b preventive vaccines and their administration, a. statutory background, b. pneumococcal, influenza and hepatitis b vaccine administration, c. covid-19 vaccine administration, d. in-home additional payment for administration of preventive vaccines, e. covid-19 monoclonal antibodies and their administration, f. summary of payment amounts for cy 2025, 2. revised payment policies for hepatitis b vaccine administration, b. revisions to payment policies for hepatitis b vaccinations, c. revisions to payment policies for hepatitis b vaccinations in rural health clinics (rhc) and federally qualified health centers (fqhc), d. regulations concerning hepatitis b vaccines and their administration, 3. payment for drugs covered as additional preventive services (§ 410.152), b. proposed fee schedule for drugs covered as additional preventive services (dcaps), (1) payment limit based on section 1847a of the act, (2) payment limit based on national average drug acquisition cost (nadac) pricing, (3) payment limit based on the federal supply schedule (fss), (4) invoice pricing, c. payment for supplying and administration of drugs under the additional preventive services benefit, d. payment for drugs covered as additional preventive services in rhcs and fqhcs, i. medicare prescription drug inflation rebate program, a. overview of the medicare prescription drug inflation rebate program, b. summary of proposed policies for the medicare prescription drug inflation rebate program, c. timeline of key dates for the medicare prescription drug inflation rebate program, 2. medicare part b drug rebates for single source drugs and biological products with prices that increase faster than the rate of inflation, a. definitions (§ 427.20), b. determination of part b rebatable drugs (§§ 427.100 through 427.101), i. definitions, ii. identification of part b rebatable drugs, iii. excluded product categories, iv. drugs and biological products with average total allowed charges below the applicable threshold, c. inflation-adjusted beneficiary coinsurance adjustment and adjusted medicare payment for part b rebatable drugs with price increases faster than inflation (§§ 427.200 through 427.201), d. determination of the rebate amount for part b rebatable drugs (§§ 427.300 through 427.304), ii. calculation of the total part b rebate amount to be paid by manufacturers, (1) scenarios in which all ndcs within a billing and payment code have negative, zero, or missing asp units, (2) scenarios in which some (but not all) ndcs have negative, zero, or missing asp units, iii. calculation of the per unit part b drug rebate amount, (1) identification of the specified amount for the applicable calendar quarter, (2) identification of the payment amount benchmark quarter, (3) identification of payment amount in the payment amount benchmark quarter, (4) identification of the benchmark period cpi-u, (5) identification of the rebate period cpi-u, (6) determination of the inflation-adjusted payment amount, iv. determination of total number of billing units, (1) units of drugs acquired through the 340b program, (2) units with a rebate under section 1927 of the social security act, (3) units that are packaged into the payment amount for an item or service and are not separately payable, (4) units when a drug is no longer a part b rebatable drug, (5) operational considerations related to the inclusion of units furnished to beneficiaries who are enrolled in medicare advantage (ma) plans, (6) units subject to discarded drug refunds, v. adjustments for changes to billing and payment codes, e. reducing the rebate amount for part b rebatable drugs in shortage and when there is a severe supply chain disruption (§§ 427.400 through 427.402), ii. reducing the rebate amount for part b rebatable drugs currently in shortage, iii. reducing the rebate amount for part b rebatable biosimilar biological products when there is a severe supply chain disruption, f. reports of rebate amounts, reconciliation, suggestion of error, and payments (§§ 427.500 through 427.505), ii. reports of rebate amounts and suggestion of error, iii. reconciliation of a rebate amount, iv. rebate report for applicable calendar quarters in cy 2023 and cy 2024, g. enforcement of manufacturer payment of rebate amounts (§ 427.600), h. severability (§ 427.10), 3. medicare part d drug rebates for drugs, biologicals, and sole source generic drugs with prices that increase faster than the rate of inflation, a. definitions (§ 428.20), b. determination of part d rebatable drugs (§§ 428.100 through 428.101), ii. identification of part d rebatable drugs, iii. drugs and biologicals with average annual total cost under part d below the applicable threshold, c. determination of the rebate amount for part d rebatable drugs (§§ 428.200 through 428.204), ii. calculation of the total rebate amount to be paid by manufacturers, iii. calculation of the per unit part d drug rebate amount, (1) calculation of the anmp for the applicable period, (2) identification of the payment amount benchmark period, (a) proposal to establish a payment amount benchmark period in certain instances of missing amp, (b) comment solicitation on alternatives considered for calculating the benchmark period manufacturer price when amp is missing, (c) identification of the payment amount benchmark period for a part d rebatable drug no longer considered to be a selected drug, (3) calculation of the benchmark period manufacturer price, (5) calculation of the inflation-adjusted payment amount, (6) situations in which manufacturers do not report units under section 1927(b)(3)(a)(iv), iv. determination of the total number of units dispensed under part d, (1) removal of units when a generic drug is no longer a part d rebatable drug, (2) exclusion of 340b acquired units from part d rebatable drug requirements, (a) estimation methodology to remove 340b units from rebate calculations, (b) comment solicitation on a medicare part d claims data repository, (c) comment solicitation on requiring covered entities to submit 340b claims data to the repository, (d) comment solicitation on timing requirements for potential submissions to a medicare part d claims data repository, (e) alternative policy considered: 340b claims identifier, v. treatment of new formulations of part d rebatable drugs, d. reducing the rebate amount for part d rebatable drugs in shortage and when there is a severe supply chain disruption or likely shortage (§§ 428.300 through 428.303), ii. reducing the rebate amount for part d rebatable drugs currently in shortage, iii. reducing the rebate amount for generic part d rebatable drugs and biosimilars when there is a severe supply chain disruption, iv. reducing the rebate amount for generic part d rebatable drugs likely to be in shortage, e. reports of rebate amounts, reconciliation, suggestion of error, and payments (§§ 428.400 through 428.405), iv. rebate reports for the applicable periods beginning october 1, 2022, and october 1, 2023, f. enforcement of manufacturer payment of rebate amounts (§ 428.500), g. severability (§ 428.10), j. request for information: building upon the mips value pathways (mvps) framework to improve ambulatory specialty care, 2. solicitation of public comments, a. participant definition, b. mvp performance assessment, c. payment methodology, d. care delivery and incentives for partnerships with accountable care entities and integration with primary care, e. health information technology and data sharing, f. health equity, g. multi-payer alignment, k. expand colorectal cancer screening, 2. statutory authority, 3. regulatory and ncd authority, 4. proposed revisions, l. requirements for electronic prescribing for controlled substances for a covered part d drug under a prescription drug plan or an ma-pd plan, 1. previous regulatory action, 2. timeline for including prescriptions written for beneficiaries in long-term care (ltc) facilities in cms epcs program compliance calculation, b. barriers to electronic prescribing of controlled substances for beneficiaries in ltc and the role of three-way communication in the ncpdp script standard, c. timeframe for including prescriptions written for beneficiaries in ltc in the cms epcs program compliance calculation, m. expand hepatitis b vaccine coverage, 3. regulation, 4. proposed regulatory revisions, n. low titer o+ whole blood transfusion therapy during ground ambulance transport, 1. ambulance fee schedule background, 2. low titer o+ whole blood transfusion therapy during ground ambulance transport, o. medicare parts a and b overpayment provisions of the affordable care act, 1. executive summary.

2. Provisions of the Proposed Regulation (Preamble)
a. Regulations Promulgated Under Section 1128J(d) of the Act
b. Relevant Litigation
c. Provisions of Proposed Regulations
IV. Updates to the Quality Payment Program
A. CY 2025 Modifications to the Quality Payment Program
b. Summary of Major Proposals
(1) Transforming the Quality Payment Program
(a) MIPS Value Pathways Development and Maintenance
(b) MVP Scoring
(c) APM Performance Pathway
(d) Data Submission for the Performance Categories
(e) MIPS Performance Category Measures and Activities
(i) Quality Performance Category
(ii) Cost Performance Category
(iii) Improvement Activities Performance Category
(iv) Promoting Interoperability Performance Category
(f) MIPS Final Scoring Methodology
(i) Scoring the Quality Performance Category
(ii) Scoring the Cost Performance Category
(g) MIPS Payment Adjustments
(h) Calculating the Final Score
(i) Third Party Intermediaries
(2) Advanced APM Proposals
(a) Overview of the APM Incentive
2. Definitions
3. Transforming the Quality Payment Program
a. Vision and Strategy Overview
b. The Role of MVPs in Transforming MIPS
(1) Overview
(2) Furthering MVP Adoption
(3) Sunset of Traditional MIPS
(4) Potential Path Forward
(5) Consideration of MVP Policies and Requirements
c. Mandatory Subgroup Reporting Requirement
(2) Specialty Composition of a Group
(3) Establishing Limits on the Composition of a Subgroup
(4) Mandatory Subgroup Reporting for Small Practice TINs
d. RFI Questions
a. CY 2025 MVP Development and Maintenance
(1) Development of New MIPS Value Pathways (MVPs)
(2) MVP Maintenance Process
(3) MVP Maintenance Updates to Previously Finalized MVPs
b. MVP Requirements and Scoring
(1) Quality Performance Category in MVPs
(a) Background on Population Health Administrative Claims-Based Measures
(b) Proposal To Use the Highest Score of All Available Population Health Measures
(2) Cost Performance Category in MVPs
(3) Improvement Activities Performance Category in MVPs
(4) Promoting Interoperability Performance Category in MVPs
c. APM Performance Pathway
(2) Establishment of the APP Plus Quality Measure Set To Align With the Universal Foundation
(3) Measures Proposed for Use in the APP Quality Measure Set and APP Plus Quality Measure Sets
(ii) Initiation and Engagement of Substance Use Disorder Treatment Measure
(iii) Screening for Social Drivers of Health Measure
(iv) Adult Immunization Status Measure
(v) Maintaining the Use of the Clinician and Clinician Group Risk-Standardized Hospital Admission Rates for Patients With Multiple Chronic Conditions Measure in the APP Quality Measure Set and Including It in the APP Plus Quality Measure Set
(vi) The APP and APP Plus Quality Measure Sets Beginning With the CY 2025 Performance Period/2027 MIPS Payment Year
d. Data Submission for the Performance Categories
(2) Proposed Minimum Criteria for a Qualifying Data Submission for the MIPS Quality, Improvement Activities, and Promoting Interoperability Performance Categories
(a) Background
(b) Quality Performance Category
(c) Improvement Activities Performance Category
(d) Promoting Interoperability Performance Category
(3) Treatment of Multiple Data Submissions
(b) Quality and Improvement Activities Performance Categories
(c) Promoting Interoperability Performance Category
f. MIPS Performance Category Measures and Activities
(1) Quality Performance Category
(b) Data Submission Criteria
(i) Data Submission Criteria for the Quality Performance Category
(c) Data Completeness Criteria
(i) Data Completeness Criteria for the Quality Performance Category
(d) Selection of Quality Measures
(i) Addition of New Quality Measures
(A) Pre-Rulemaking Process
(ii) Removal of Quality Measures
(iii) Inventory of Quality Measures
(e) Quality Performance Category Requests for Information
(i) Survey Modes for the Administration of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey Request for Information
(ii) Guiding Principles for Patient-Reported Outcome Measures in Federal Models, and Quality Reporting and Payment Programs Request for Information
(2) Cost Performance Category
(a) Proposed Updates to MIPS Episode-Based Measure Inventory
(i) Background on Episode-Based Measure Development and Use
(ii) Overview of Measure Development Process for New Episode-Based Measures
(iii) Description of Six New Episode-Based Measures Proposed for Adoption Beginning With the CY 2025 Performance Period/2027 MIPS Payment Year
(iv) Background on Episode-Based Measure Reevaluation and Maintenance
(v) Overview of Measure Reevaluation Process for Episode-Based Measures
(vi) Description of Proposed Modifications to the Routine Cataract Removal With Intraocular Lens (IOL) Implantation Measure With the Newly Titled Cataract Removal With IOL Implantation Measure
(vii) Description of the Proposed Modifications to the ST-Elevation Myocardial Infarction (STEMI) With Percutaneous Coronary Intervention (PCI) Measure With the Newly Titled Inpatient (IP) Percutaneous Coronary Intervention (PCI) Measure
(viii) Pre-Rulemaking Measure Review Process
(ix) Proposal To Adopt Six Episode-Based Measures and Modify Two Episode-Based Measures
(b) Reliability and Case Minimum
(c) Proposed Revisions to the Operational List of Care Episode and Patient Condition Groups and Codes
(d) Proposed Removal Criteria for MIPS Cost Measures
(3) Improvement Activities Performance Category
(b) Improvement Activities Inventory
(i) Annual Call for Activities Background
(ii) Codification of Improvement Activity Removal Factors
(iii) Changes to the Improvement Activities Inventory
(iv) Improvement Activity Scoring and Reporting Policies
(4) Promoting Interoperability Performance Category
(b) Current Definition of CEHRT for the Quality Payment Program
(c) Potential Future Update of the SAFER Guides Measure
(i) Background
(ii) Status of Updates to SAFER Guides
(d) Modification of the Definition of Meaningful EHR User for Healthcare Providers That Have Committed Information Blocking
(e) Future Goals of the Promoting Interoperability Performance Category
(i) Future Goals With Respect to Fast Healthcare Interoperability Resources® (FHIR) APIs for Patient Access
(ii) Improving Cybersecurity Practices
(iii) Improving Prior Authorization Processes
(f) Requirements for the Promoting Interoperability Performance Category for the CY 2025 Performance Period/2027 MIPS Payment Year
(i) Objectives and Measures for the CY 2025 Performance Period/2027 MIPS Payment Year
(ii) Scoring Methodology for the CY 2025 Performance Period/2027 MIPS Payment Year
(iii) Exclusion Redistribution
(iv) ONC Health IT Certification Criteria
(g) Request for Information (RFI) Regarding Public Health Reporting and Data Exchange
(ii) Goals for Public Health Reporting
(iii) Public Health in the ONC Health IT Certification Program
(iv) RFI Questions
(1) Questions for Goal #1: Quality, Timeliness, and Completeness of Public Health Reporting
(2) Questions for Goal #2: Flexibility and Adaptability of the Public Health Reporting Enterprise
(3) Questions for Goal #3: Increasing Bi-Directional Exchange With Public Health Agencies
(4) Questions for Goal #4: Significantly Reduce Reporting Burden for Healthcare Providers
f. MIPS Final Score Methodology
(1) Performance Category Scores
(b) Scoring the Quality Performance Category for the Following Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs, QCDR Measures, the CAHPS for MIPS Survey Measure and Administrative Claims Measures
(i) Scoring for Topped Out Measures in Specialty Measure Sets With Limited Measure Choice
(ii) Proposed Approach for Determining Topped Out Measures Impacted by Limited Measure Choice and Subject to the Proposed Defined Topped Out Measure Benchmark and the Proposed List of Measures That Would Be Subject to the Defined Topped Out Measure Benchmark for the CY 2025 Performance Period/2027 MIPS Payment Year
(iii) Complex Organization Adjustment for Virtual Groups and APM Entities
(c) Scoring the Quality Performance Category Through MIPS for ACOs in the Shared Saving Program.
(i) Proposal To Score for Shared Savings Program ACOs Reporting Medicare CQMs Using Flat Benchmarks
(d) Cost Performance Category Score
(i) Scoring the Cost Performance Category Background
(ii) Benchmark Methodology for Scoring the Cost Performance Category
(A) Background on Methodology for Scoring the Cost Performance Category
(B) Proposed Modification to Scoring Methodology for the Cost Performance Category Beginning With CY 2024 Performance Period/2026 MIPS Payment Year
(iii) Proposed Adoption of Additional Cost Measure Exclusion Policy
(A) Background on Cost Measure Exclusion Policy
(B) Proposal To Permit Exclusion of a Cost Measure When Impacted by Errors and When Significant Changes Occur Outside of the Performance Period
g. MIPS Payment Adjustments
(2) Establishing the Performance Threshold
(a) Statutory Authority and Background
(b) Establishing the Performance Threshold Methodology for the 2027, 2028, and 2029 MIPS Payment Years
(c) Establishing the Performance Threshold for the CY 2025 Performance Period/2027 MIPS Payment Year
(3) Example of Adjustment Factors
h. Review and Correction of MIPS Final Score—Feedback and Information To Improve Performance
i. Calculating the Final Score
(2) Proposal To Adopt Reweighting Performance Category(ies) Policy When a Third Party Intermediary Did Not Submit Data Due to Reasons Outside the MIPS Eligible Clinician's Control
j. Third Party Intermediaries General Requirements
(1) Requirements for CMS-Approved Survey Vendors
(b) Requirement To Submit Cost of Services
k. Overview of QP Determinations and the APM Incentive
(2) Payment Amount and Patient Count Methods
(a) Attributed Beneficiary
(b) Attribution-Eligible Beneficiary
(3) QP Thresholds and Partial QP Thresholds
(4) APM Incentive Payment
V. Collection of Information Requirements
A. Wage Estimates
B. Proposed Information Collection Requirements (ICRs)
1. ICRs Regarding Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-In of Payment Reductions (§ 414.504)
2. ICRs Regarding the Updates to the Medicare Diabetes Prevention Program
3. ICRs Regarding the Medicare Shared Savings Program
4. ICRs Regarding Rebate Reduction Requests Submitted Under Sections 11101 and 11102 of the Inflation Reduction Act
5. ICRs Regarding Medicare Parts A and B Overpayment Provisions of the Affordable Care Act (§ 401.305(b)(1), (2), and (3))
6. The Quality Payment Program ( 42 CFR Part 414 and Section IV of This Proposed Rule)
(1) ICRs Associated With Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs)
(a) Summary of Annual Quality Payment Program Burden Estimates
(2) Summary of Proposed Changes for the Quality Payment Program: MIPS
(3) Summary of Quality Payment Program Changes: Advanced APMs
(4) Framework for Understanding the Burden of MIPS Data Submission
b. ICRs Regarding the Virtual Group Election (§ 414.1315)
c. ICRs Regarding Third Party Intermediaries (§ 414.1400)
(2) QCDR Self-Nomination Applications
(a) Simplified Self-Nomination Process and Other Requirements
(b) Full QCDR Self-Nomination Process and Other Requirements
(3) Qualified Registry Self-Nomination Process and Other Requirements
(a) Simplified Qualified Registry Self-Nomination Process
(b) Full Qualified Registry Self-Nomination Process
(4) Third Party Intermediary Plan Audits
(a) Targeted Audits
(b) Participation Plans
(c) Corrective Action Plans (CAPs)
(d) Transition Plans
(e) Estimated Burden for Third Party Intermediary Plan Audits
(5) Survey Vendor Requirements
d. ICRs Regarding Open Authorization (OAuth) Credentialing and Token Request Process
e. ICRs Regarding Quality Data Submission (§§ 414.1318, 414.1325, 414.1335, and 414.1365)
(2) Changes and Adjustments to Quality Performance Category Respondents
(3) Quality Payment Program Identity Management Application Process
(4) Quality Data Submission by Clinicians: Medicare Part B Claims-Based Collection Type
(5) Quality Data Submission by Individuals and Groups Using MIPS CQM and QCDR Collection Types
(6) Quality Data Submission by Clinicians and Groups: eCQM Collection Type
(7) ICRs Regarding Burden for MVP Reporting
(a) Burden for MVP Reporting Requirements
(i) Burden for MVP Registration: Individuals, Groups and APM Entities
(ii) Burden for Subgroup Registration
(iii) Burden for MVP Quality Performance Category Submission
(8) Beneficiary Responses to CAHPS for MIPS Survey
(9) Group Registration for CAHPS for MIPS Survey
f. ICRs Regarding the Call for MIPS Quality Measures
g. ICRs Regarding Promoting Interoperability Data (§§ 414.1375 and 414.1380)
(2) Reweighting Applications for MIPS Performance Categories
(3) Submitting Promoting Interoperability Data
h. ICRs Regarding Improvement Activities Submission (§§ 414.1305, 414.1355, 414.1360, and 414.1365)
i. ICRs Regarding the Nomination of Improvement Activities (§ 414.1360)
j. ICRs Regarding the Nomination of MVPs
k. ICRs Regarding the Cost Performance Category (§ 414.1350)
l. ICRs Regarding Partial QP Elections (§§ 414.1310(b) and 414.1430)
m. ICRs Regarding Other Payer Advanced APM Determinations: Payer-Initiated Process (§ 414.1445) and Eligible Clinician-Initiated Process (§ 414.1445)
(1) Payer-Initiated Process (§ 414.1445)
(2) Eligible Clinician-Initiated Process (§ 414.1445)
(3) Submission of Data for QP Determinations Under the All-Payer Combination Option (§ 414.1440)
n. ICRs Regarding Voluntary Participants Election to Opt-Out of Performance Data Display on Compare Tools (§ 414.1395)
C. Summary of Proposed Annual Burden Estimates
D. Submission of PRA-Related Comments
VI. Response to Comments
VII. Regulatory Impact Analysis
A. Statement of Need
1. Statutory Provisions
a. Clinical Laboratory Fee Schedule (CLFS)—Proposed Revisions Consistent With Recent Statutory Changes
b. Medicare Prescription Drug Inflation Rebate Program
c. Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan
d. Quality Payment Program
2. Discretionary Provisions
a. Drugs and Biological Products Paid Under Medicare Part B
b. RHCs and FQHCs
c. Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
d. Medicare Shared Savings Program
e. Medicare Part B Payment for Preventive Services
f. Expand Colorectal Cancer Screening
g. Expand Hepatitis B Vaccine Coverage
h. Medicare Parts A and B Overpayment Provisions of the Affordable Care Act (§ 401.305(b)(1) Through (3))
B. Overall Impact
C. Changes in Relative Value Unit (RVU) Impacts
1. Resource-Based Work, PE, and MP RVUs
2. CY 2025 PFS Impact Discussion
a. Changes in RVUs
D. Impact of Changes Related to Telehealth Services
E. Other Provisions of the Regulation
1. Impact of Proposals for Medicare Parts A and B Payment for Dental Services Inextricably Linked to Specific Covered Medical Services
2. Impact of Proposed Changes Related to Supervision of Outpatient Therapy Services in Private Practices
3. Impacts of Proposed Changes Related to Advanced Primary Care Management Services
4. Impact of Proposed Changes Related to Strategies for Improving Global Surgery Payment Accuracy
5. Drugs and Biological Products Paid Under Medicare Part B
a. Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts
b. Impacts Related to the Payment Limit Calculation When Manufacturers Report Negative or Zero Average Sales
c. Impacts Related to the Payment of Radiopharmaceuticals in the Physician Office
d. Impacts Related to Immunosuppressive Therapy
e. Impacts Related to Clotting Factors
6. Impacts Related to Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
7. Changes in the RHC and FQHC CfCs: Provision of Services (§ 491.9(a)(2) and (c)(2)(ii) and (vi))
Provision of Services (§ 491.9)
8. Clinical Laboratory Fee Schedule
9. Effects of Proposals Relating to the Medicare Diabetes Prevention Program Expanded Model
a. Effects on Beneficiaries
b. Effects on the Market
c. Payment for MDPP Services
d. Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
10. Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
11. Medicare Shared Savings Program
a. General Impacts
b. Compliance With Requirements of Section 1899(i)(3) of the Act
12. Medicare Part B Payment for Preventive Services
13. Impact of Provisions for Medicare Prescription Drug Inflation Rebate Program
14. Expand Colorectal Cancer Screening
15. Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan
16. Expand Hepatitis B Vaccine Coverage
17. Low Titer O+ Whole Blood Transfusion Therapy During Ground Ambulance Transport
18. Updates to the Quality Payment Program
A. Overall MIPS Modeling Approach and Data Assessment
(1) MIPS Modeling Approach
(2) Data Used To Estimate Future MIPS Performance
b. APM Incentive Payments to QPs in Advanced APMs and Other Payer Advanced APMs
c. Estimated Number of MIPS Eligible Clinicians in the CY 2025 Performance Period/2027 MIPS Payment Year
(1) Initial Population of Clinicians Included in the RIA Baseline and Proposed Policies Models
(2) Estimated Number of MIPS Eligible Clinicians After Applying Eligibility Assumptions
(a) Methods and Assumptions Used To Estimate Eligibility
(b) MIPS Eligibility Estimates
d. Modeling Approach and Methods for MIPs Value Pathways (MVPs) and Traditional MIPS
(1) Summary of Approach
(2) Methodology To Assess Impact for MIPS Value Pathways
(a) MVP Participant Assumptions
(b) MVP Scoring Methods and Assumptions
(3) Methodology To Assess Impact for Traditional MIPS
(a) Methodology To Estimate the Quality Performance Category Score
(b) Methodology To Estimate the Cost Performance Category Score
(c) Methodology To Estimate the Promoting Interoperability Performance Category Score
(d) Methodology To Estimate the Improvement Activities Performance Category Score
(e) Methodology To Estimate the Complex Patient Bonus Points
(f) Methodology To Estimate the Final Score
(g) Methodology To Estimate the MIPS Payment Adjustment
(4) Simulation Results and Projected Impact to MIPS Eligible Clinicians
(a) Impact to Clinician Eligibility
(b) Impact to Clinician's Final Scores
(i) Impact to Small and Solo Practices
(ii) Impact to Rural Providers
(iii) Impact to Safety Net Providers
(a) Updated Definition of Safety Net Providers
(c) Impact to MIPS Eligible Clinicians' Payment Adjustments
e. Additional Impacts From Outside Payment Adjustments
(1) Burden Overall
(2) Additional Impacts to Clinicians
(a) Impact on Third Party Intermediaries
(b) Modifications to the Improvement Activities Inventory
(c) Modifications to Improvement Activities Scoring and Reporting Policies
(d) MVP Maintenance Process
(e) Reweighting Performance Categories When Data Is Not Submitted Due to Reasons Outside the Clinician's Control
(f) Advanced Primary Care Management
(g) Mandatory Subgroup Registration
(h) APM Performance Pathway Plus Quality Measure Set
i. Assumptions & Limitations
F. Alternatives Considered
1. Alternatives Considered Related to Strategies for Improving Global Surgery Payment Accuracy
2. Alternatives Considered Related to the Supervision of Outpatient Therapy Services in Private Practices
3. Alternatives Considered for the Quality Payment Program
G. Impact on Beneficiaries
1. Medicare Shared Savings Program Provisions
2. Quality Payment Program
H. Estimating Regulatory Familiarization Costs
I. Accounting Statement
J. Conclusion
List of Subjects
42 CFR Part 401
42 CFR Part 405
42 CFR Part 410
42 CFR Part 411
42 CFR Part 414
42 CFR Part 423
42 CFR Part 424
42 CFR Part 425
42 CFR Part 427
42 CFR Part 428
42 CFR Part 491
PART 401—GENERAL ADMINISTRATIVE REQUIREMENTS
PART 405—FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
PART 411—EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
PART 424—CONDITIONS FOR MEDICARE PAYMENT
PART 425—MEDICARE SHARED SAVINGS PROGRAM
PART 427—MEDICARE PART B DRUG INFLATION REBATE PROGRAM
Subpart A—General Provisions
Subpart B—Determination of Part B Rebatable Drugs
Subpart C—Coinsurance Adjustment and Adjusted Medicare Payment for Part B Rebatable Drugs With Price Increases Faster Than Inflation
Subpart D—Determination of the Rebate Amount for Part B Rebatable Drugs
Subpart E—Reducing the Rebate Amount for Part B Rebatable Drugs in Shortage and When There Is a Severe Supply Chain Disruption
Subpart F—Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments
Subpart G—Enforcement of Manufacturer Payment of Rebate Amounts
Equation 1 to Paragraph (b)(1)
PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM
Subpart B—Determination of Part D Rebatable Drugs
Subpart C—Determination of the Rebate Amount for Part D Rebatable Drugs
Subpart D—Reducing the Rebate Amount for Part D Rebatable Drugs in Shortage and When There is a Severe Supply Chain Disruption or Likely Shortage
Subpart E—Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments
Subpart F—Enforcement of Manufacturer Payment of Rebate Amounts
Subpart D—Reducing the Rebate Amount for Part D Rebatable Drugs in Shortage and When There Is a Severe Supply Chain Disruption or Likely Shortage
PART 491—CERTIFICATION OF CERTAIN HEALTH FACILITIES
Appendix 1: MIPS Quality Measures
Table Group A: New MIPS Quality Measures Proposed for the CY 2025 Performance Period/2027 MIPS Payment Year and Future Years

Enhanced Content - Submit Public Comment

Submit a public comment on this document

Enhanced Content - Read Public Comments

19 comments have been received at regulations.gov, across 1 docket.

Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.

Docket Title	Document ID	Comments
Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program (CMS-1807-P)		19

Enhanced Content - Sharing

Email this document to a friend

Enhanced Content - Document Print View

Print this document

Enhanced Content - Document Tools

These tools are designed to help you understand the official document better and aid in comparing the online edition to the print edition.

These markup elements allow the user to see how the document follows the Document Drafting Handbook that agencies use to create their documents. These can be useful for better understanding how a document is structured but are not part of the published document itself.

Enhanced Content - Developer Tools

This document is available in the following developer friendly formats:.

JSON: Normalized attributes and metadata
XML: Original full text XML
MODS: Government Publishing Office metadata

More information and documentation can be found in our developer tools pages .

Official Content

View printed version (PDF)

This PDF is the current document as it appeared on Public Inspection on 07/10/2024 at 4:15 pm. It was viewed 1 times while on Public Inspection.

If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register. Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. 1503 & 1507 . Learn more here .

Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS).

Proposed rule.

This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of, and proposing policies for, the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; updates to the Medicare Diabetes Prevention Program expanded model; payment for dental services inextricably linked to specific covered medical services; updates to drugs and biological products paid under Part B including immunosuppressive drugs and clotting factors; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to policies for Rural Health Clinics and Federally Qualified Health Centers; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or a Medicare Advantage Prescription Drug (MA-PD) plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to Clinical Laboratory Fee Schedule regulations; updates to the diabetes payment structure and PHE flexibilities; expansion of colorectal cancer screening and Hepatitis B vaccine coverage and payment; establishing payment for drugs covered as additional preventive services; Medicare Parts A and B Overpayment Provisions of the Affordable Care Act.

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 9, 2024.

In commenting, please refer to file code CMS-1807-P.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov . Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, P.O. Box 8016, Baltimore, MD 21244-8016.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1807-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

[email protected] , for any issues not identified below. Please indicate the specific issue in the subject line of the email.

Michael Soracoe, (410) 786-6312, Morgan Kitzmiller, (410) 786-1623, or [email protected] , for issues related to practice expense, work RVUs, conversion factor, and PFS specialty-specific impacts.

Kris Corwin, (410) 786-8864, or [email protected] , for issues related to strategies for updates to practice expense data collection and methodology.

Hannah Ahn, (814) 769-0143, or [email protected] , for issues related to potentially misvalued services under the PFS.

Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, Mikayla Murphy, (667) 414-0093, or [email protected] , for issues related to direct supervision using two-way audio/video communication technology, telehealth, and other services involving communications technology.

Tamika Brock, (312) 886-7904, or [email protected] , for issues related to teaching physician billing for services involving residents in teaching settings.

Sarah Leipnik, (410) 786-3933, Mikayla Murphy, (667) 414-0093, Regina Walker-Wren, (410) 786-9160, or [email protected] , for issues related to payment for caregiver training services and addressing health-related social needs (community health integration, principal illness navigation, and social determinants of health risk assessment).

Erick Carrera, (410) 786-8949, or [email protected] , for issues related to office/outpatient evaluation and management visit inherent complexity add-one.

Sarah Irie, (410) 786-1348, Emily Parris (667) 414-0418, or [email protected] , for issues related to payment for advanced primary care management service.

Sarah Leipnik, (410) 786-3933, or [email protected] , for issues related to global surgery payment accuracy.

Pamela West, (410) 786-2302, for issues related to supervision of outpatient therapy services in private practices, certification of therapy plans of care, and KX modifier threshold.

Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-9160, Erick Carrera, (410) 786-8949, Mikayla Murphy, (667) 414-0093, or [email protected] , for issues related to advancing access to behavioral health services.

Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949, Zehra Hussain, (214) 767-4463, or [email protected] , for issues related to dental services inextricably linked to specific covered medical services.

Zehra Hussain, (214) 767-4463, or [email protected] , for issues related to payment of skin substitutes.

Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, Rachel Radzyner, (410) 786-8215, Rebecca Ray, (667) 414-0879, and Jae Ryu, (667) 414-0765 for issues related to Drugs and Biological Products Paid Under Medicare Part B.

[email protected] , for issues related to complex drug administration. Start Printed Page 61597

Glenn McGuirk, (410) 786-5723, or [email protected] for issues related to Clinical Laboratory Fee Schedule.

Lisa Parker, (410) 786-4949, or [email protected] , for issues related to FQHC payments.

Heidi Oumarou, (410) 786-7942, for issues related to the FQHC market basket.

Michele Franklin, (410) 786-9226, or [email protected] , for issues related to RHC payments.

Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for issues related to RHCs and FQHCs and Conditions for Certification or Coverage.

Colleen Barbero (667) 290-8794, for issues related to Medicare Diabetes Prevention Program.

Ariana Pitcher, (667) 290-8840, or [email protected] , for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs.

Sabrina Ahmed, (410) 786-7499, or [email protected] , for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance standard and quality reporting requirements.

Janae James, (410) 786-0801, or [email protected] , for issues related to Shared Savings Program beneficiary assignment and benchmarking methodology.

Richard (Chase) Kendall, (410) 786-1000, or [email protected] , for issues related to reopening ACO payment determinations, and mitigating the impact of significant, anomalous, and highly suspect billing activity on Shared Savings Program financial calculations.

Lucy Bertocci, (410) 786-3776, or [email protected] , for issues related to Shared Savings Program prepaid shared savings, advance investment payments, beneficiary notice and eligibility requirements.

Rachel Radzyner, (410) 786-8215, for issues related to payment for preventative services, including preventive vaccine administration and drugs covered as additional preventive services.

Elisabeth Daniel, (667) 290-8793, for issues related to the Medicare Prescription Drug Inflation Rebate Program.

Genevieve Kehoe, [email protected] , or 1-844-711-2664 (Option 4) for issues related to the Request for Information: Building upon the MIPS Value Pathways (MVPs) Framework to Improve Ambulatory Specialty Care.

Kimberly Long, (410) 786-5702, for issues related to expanding colorectal cancer screening.

Rachel Katonak, (410) 786-8564, for issues related to expanding Hepatitis B vaccine coverage.

Mei Zhang, (410) 786-7837, for issues related to requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan (section 2003 of the SUPPORT Act).

Katie Parker, (410) 786-0537, for issues related to Parts A and B overpayment provisions of the Affordable Care Act.

Amy Gruber, (410) 786-1542, for issues related to low titer O+ whole blood transfusion therapy during ground ambulance transport.

Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648, for inquiries related to Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program.

Danielle Drayer, (516) 965-6630, for inquiries related to Alternative Payment Models (APMs).

Addenda Available Only Through the Internet on the CMS website: The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html . Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS Federal Register and other related documents. For the CY 2025 PFS proposed rule, refer to item CMS-1807-P. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this proposed rule and posted on the CMS website identified above should contact [email protected] .

CPT (Current Procedural Terminology) Copyright Notice: Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2020 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

This major annual rule proposes to revise payment policies under the Medicare PFS and makes other policy changes, including proposals to implement certain provisions of the Further Continuing Appropriations and Other Extensions Act of 2024 ( Pub. L. 118-22 , November 16, 2023), Consolidated Appropriations Act, 2023 ( Pub. L. 117-328 , September 29, 2022), Inflation Reduction Act of 2022 (IRA) ( Pub. L. 117-169 , August 16, 2022), Consolidated Appropriations Act, 2022 ( Pub. L. 117-103 , March 15, 2022), Consolidated Appropriations Act, 2021 (CAA, 2021) ( Pub. L. 116-260 , December 27, 2020), Bipartisan Budget Act of 2018 (BBA of 2018) ( Pub. L. 115-123 , February 9, 2018) and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) ( Pub. L. 115-271 , October 24, 2018), related to Medicare Part B payment. In addition, this major proposed rule includes proposals regarding other Medicare payment policies described in sections III. and IV.

This rulemaking also proposes to codify policies previously established in guidance for the Medicare Prescription Drug Inflation Rebate Program at new parts 427 and 428, including clarifications to certain existing policies, consistent with sections 1847A(i) and 1860D-14B of the Act. This rulemaking also proposes new policies for the Medicare Prescription Drug Inflation Rebate Program, including removal of units of drugs subject to discarded drug refunds from the Part B rebate amounts, exclusion of units for which a manufacturer provides a discount under the 340B Program from the Part D inflation rebate amount starting on January 1, 2026, the process for reconciliation of a Part B or Part D rebate amount to incorporate certain revised information, and procedures for imposing civil money penalties on manufacturers that do not pay Part B or Part D inflation rebate amounts within a specified period of time.

This rulemaking proposes to update the Rural Health Clinic (RHC) and Federally Qualified Health Clinic (FQHC) Conditions for Certification and Conditions for Coverage (CfCs), respectively, by clarifying the requirements and intent of the program regarding the provision of services. We also aim to ensure RHCs are provided flexibility in the services they offer, including specialty and laboratory services. Start Printed Page 61598

This rulemaking also proposes to further advance Medicare's overall value-based care strategy of growth, alignment, and equity through the Medicare Shared Savings Program (Shared Savings Program) and the Quality Payment Program. The structure of the programs enables us to develop a set of tools for measuring and encouraging improvements in care, which may support a shift to clinician payment over time into Advanced Alternative Payment Models (APMs) and accountable care arrangements which reduce care fragmentation and unnecessary costs for patients and the health system.

This rulemaking also proposes changes to Medicare regulations regarding requirements for reporting and returning Parts A and B overpayments.

Please note, some sections of this proposed rule contain a request for information (RFI). In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4) , these general solicitations are exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency's full consideration, are not generally considered information collections and therefore not subject to the PRA. Respondents are encouraged to provide complete but concise responses. These RFIs are issued solely for information and planning purposes; they do not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. These RFIs do not commit the U.S. Government to contract for any supplies or services or make a grant award. Further, CMS is not seeking proposals through these RFIs and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to these RFIs; all costs associated with responding to these RFIs will be solely at the interested party's expense. Not responding to these RFIs does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor these RFI announcements for additional information pertaining to these requests. Please note that CMS will not respond to questions about the policy issues raised in these RFIs. CMS may or may not choose to contact individual responders. Such communications would only serve to further clarify written responses. Contractor support personnel may be used to review RFI responses. Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or issue a grant. Information obtained as a result of these RFIs may be used by the U.S. Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. These RFIs should not be construed as a commitment or authorization to incur cost for which reimbursement would be required or sought. All submissions become U.S. Government property and will not be returned. CMS may publicly post the comments received, or a summary thereof.

Section 1848 of the Social Security Act (the Act) requires us to establish payments under the PFS, based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: work, practice expense (PE), and malpractice (MP) expense. In addition, the statute requires that each year we establish, by regulation, the payment amounts for physicians' services paid under the PFS, including geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas.

In this major proposed rule, we are proposing to establish RVUs for CY 2025 for the PFS to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes discussions and provisions regarding several other Medicare Part B payment policies, Medicare and Medicaid provider and supplier enrollment policies, and other policies regarding programs administered by CMS.

Specifically, this proposed rule addresses:

Background (section II.A.)
Determination of PE RVUs (section II.B.)
Potentially Misvalued Services Under the PFS (section II.C.)
Payment for Medicare Telehealth Services Under Section 1834(m) of the Act (section II.D.)
Valuation of Specific Codes (section II.E.)
Evaluation and Management (E/M) Visits (section II.F.)
Enhanced Care Management (section II.G.)
Supervision of Outpatient Therapy Services in Private Practices, Certification of Therapy Plans of Care with a Physician or NPP Order, and KX Modifier Thresholds (section II.H.)
Advancing Access to Behavioral Health Services (section II.I.)
Proposals on Medicare Parts A and B Payment for Dental Services Inextricably Linked to Specific Covered Services (section II.J.)
Payment for Skin Substitutes (section II.K.)
Drugs and Biological Products Paid Under Medicare Part B (section III.A.)
Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) (section III.B.)
Rural Health Clinic (RHC) and Federally Qualified Health Center (FQHC) Conditions for Certification and Conditions for Coverage (CfCs) (section III.C.)
Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions (section III.D.)
Medicare Diabetes Prevention Program (MDPP) (section III.E.)
Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs) (section III.F.)
Medicare Shared Savings Program (section III.G.)
Medicare Part B Payment for Preventive Services (§§ 410.10, 410.57, 410.64, 410.152) (section III.H.)
Medicare Prescription Drug Inflation Rebate Program (section III.I.)
Request for Information: Building upon the MIPS Value Pathways (MVPs) Framework to Improve Ambulatory Specialty Care (section III.J.)
Expand Colorectal Cancer Screening (section III.K.)
Requirements for Electronic Prescribing for Controlled Substances for a Covered Part D Drug under a Prescription Drug Plan or an MA-PD Plan (section III.L.)
Expand Hepatitis B Vaccine Coverage (section III.M.)
Low Titer O+ Whole Blood Transfusion Therapy During Ground Ambulance Transport (section III.N.)
Medicare Parts A and B Overpayment Provisions of the Affordable Care Act (section III.O.)

Updates to the Quality Payment Program (section IV.) Start Printed Page 61599

Collection of Information Requirements (section V.)
Response to Comments (section VI.)
Regulatory Impact Analysis (section VII.)

We have determined that this proposed rule is economically significant. We estimate the CY 2025 PFS conversion factor to be 32.3562 which reflects a 0.05 percent positive budget neutrality adjustment required under section 1848(c)(2)(B)(ii)(II) of the Act, the 0.00 percent update adjustment factor specified under section 1848(d)(19) of the Act, and the removal of the temporary 2.93 percent payment increase for services furnished from March 9, 2024, through December 31, 2024, as provided in the CAA, 2024. For a detailed discussion of the economic impacts, see section VII., Regulatory Impact Analysis, of this proposed rule.

In accordance with section 1848 of the Social Security Act (the Act), CMS has paid for physicians' services under the Medicare physician fee schedule (PFS) since January 1, 1992. The PFS relies on national relative values that are established for work, practice expense (PE), and malpractice (MP), which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19, 1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) (Pub. L. 101-508, November 5, 1990). The final rule published in the November 25, 1991 Federal Register ( 56 FR 59502 ) set forth the first fee schedule used for Medicare payment for physicians' services.

We note that throughout this proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.

Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding malpractice (MP) expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service specific PE RVUs. We refer readers to the CY 2010 Physician Fee Schedule (PFS) final rule with comment period ( 74 FR 61743 through 61748 ) for a more detailed explanation of the PE methodology.

We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the American Medical Association (AMA) Relative Value Scale Update Committee (RUC) and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work RVUs under the PFS and proposed changes to the PE methodology in the CY 2007 PFS proposed rule ( 71 FR 37242 ) and the CY 2007 PFS final rule with comment period ( 71 FR 69629 ).

We use survey data on indirect PEs incurred per hour worked to develop the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty obtained from the AMA's Socioeconomic Monitoring System (SMS). The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.

When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology or how the PE/HR data are used. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period ( 74 FR 61751 ), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period ( 74 FR 61751 ), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.

Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.

Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.

Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.

We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties are not Start Printed Page 61600 separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.

Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file titled “CY 2025 PFS proposed rule PE/HR” on the CMS website under downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html .

For CY 2025, we have incorporated the available utilization data for two new specialties, Marriage and Family Therapist (MFT) and Mental Health Counselor (MHC), which we recognized effective January 1, 2024, in accordance with section 4121 of the CAA, 2023. We are proposing to use proxy PE/HR values for these new specialties, as there are no PPIS data for these specialties, by crosswalking the PE/HR as follows from specialties that furnish similar services in the Medicare claims data:

Marriage and Family Therapist (MFT) from Licensed Clinical Social Workers; and
Mental Health Counselor (MHC) from Licensed Clinical Social Workers

These updates are reflected in the “CY 2025 PFS proposed rule PE/HR” file available on the CMS website under the supporting data files for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html .

To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.

The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.

We allocate the indirect costs at the code level based on the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:

For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
Then, we incorporate the specialty specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.

For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.

Diagnostic services are generally comprised of two components: a professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different healthcare providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)

For a more detailed description of the PE RVU methodology, we direct readers to the CY 2010 PFS final rule with comment period ( 74 FR 61745 through 61746 ). We also direct readers to the file titled “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/ Start Printed Page 61601 Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html . This file contains a table that illustrates the calculation of PE RVUs as described in this proposed rule for individual codes.

First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty specific PE/HR data calculated from the surveys.

Sum the costs of each direct input.

Step 1: Sum the direct costs of the inputs for each service.

Step 2: Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the projected aggregate work RVUs.

Step 3: Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service.

Step 4: Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to the direct costs for each service (as calculated in Step 1).

Step 5: Convert the results of Step 4 to an RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5. Different CFs would result in different direct PE scaling adjustments, but this has no effect on the final direct cost PE RVUs since changes in the CFs and the associated direct scaling adjustments offset one another.

Create indirect allocators.

Step 6: Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.

Step 7: Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.

We generally use an average of the three most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule ( 82 FR 52982 through 59283 ) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning a specialty mix based on the specialties of the practitioners reporting the services in the claims data, we use the expected specialty that we identify on a list developed based on medical review and input from expert interested parties. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and other interested parties on changes to this list annually. Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, “always therapy” services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule ( 82 FR 52982 through 52983 ) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category.

Step 8: Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: the direct PE RVUs; the clinical labor PE RVUs; and the work RVUs.

For most services the indirect allocator is: indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.

There are two situations where this formula is modified:

If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.

( Note: For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.)

For presentation purposes, in the examples in the download file titled “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service.

The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).

Apply a scaling adjustment to the indirect allocators.

Step 9: Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data.

Step 10: Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.

Step 11: Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8.

Calculate the indirect practice cost index.

Step 12: Using the results of Step 11, calculate aggregate pools of specialty specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.

Step 13: Using the specialty specific indirect PE/HR data, calculate specialty specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.

Step 14: Using the results of Step 12 and Step 13, calculate the specialty specific indirect PE scaling factors. Start Printed Page 61602

Step 15: Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty specific indirect scaling factor by the average indirect scaling factor for the entire PFS.

Step 16: Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (Note: For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.)

Step 17: Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.

Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS BN. (See “Specialties excluded from ratesetting calculation” later in this proposed rule.)

Step 19: Apply the phase-in of significant RVU reductions and its associated adjustment. Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased in over a 2-year period. In implementing the phase-in, we consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach limits the year one reduction for the service to the maximum allowed amount (that is, 19 percent), and then phases in the remainder of the reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the total RVUs for all services that are not new or revised codes decrease by no more than 19 percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period ( 80 FR 70927 through 70931 ).

Specialties excluded from ratesetting calculation: To calculate the PE and MP RVUs, we exclude certain specialties, such as NPPs paid at a percentage of the PFS and low volume specialties, from the calculation. These specialties are included to calculate the BN adjustment. They are displayed in Table 1.

Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in creating the file consistent with the current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the Start Printed Page 61604 manner in which the modifiers are applied.

We also adjust volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.

Beginning in CY 2022, section 1834(v)(1) of the Act required that we apply a 15 percent payment reduction for outpatient occupational therapy services and outpatient physical therapy services that are provided, in whole or in part, by a physical therapist assistant (PTA) or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the Act required CMS to establish modifiers to identify these services, which we did in the CY 2019 PFS final rule ( 83 FR 59654 through 59661 ), creating the CQ and CO payment modifiers for services provided in whole or in part by PTAs and OTAs, respectively. These payment modifiers are required to be used on claims for services with dates of service beginning January 1, 2020, as specified in the CY 2020 PFS final rule ( 84 FR 62702 through 62708 ). We applied the 15 percent payment reduction to therapy services provided by PTAs (using the CQ modifier) or OTAs (using the CO modifier), as required by statute. Under sections 1834(k) and 1848 of the Act, payment is made for outpatient therapy services at 80 percent of the lesser of the actual charge or applicable fee schedule amount (the allowed charge). The remaining 20 percent is the beneficiary copayment. For therapy services to which the new discount applies, payment will be made at 85 percent of the 80 percent of allowed charges. Therefore, the volume discount factor for therapy services to which the CQ and CO modifiers apply is: (0.20 + (0.80* 0.85), which equals 88 percent.

We note that for CY 2025, we are proposing mandatory use of the 54 and 55 modifiers when practitioners furnishing global surgery procedures share in patient care and intend only to furnish preoperative/intraoperative or postoperative portions of the total global procedure. If finalized, this proposal will likely increase the number of claims subject to the adjustment described in the discussion above. We discuss this proposal in section II.G. of this proposed rule.

For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.

Work RVUs: The setup file contains the work RVUs from this proposed rule.

The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 + interest rate)^ life of equipment)))) + maintenance)

minutes per year = maximum minutes per year if usage were continuous (that is, usage=1); generally, 150,000 minutes.

usage = variable, see discussion below in this proposed rule.

price = price of the particular piece of equipment.

life of equipment = useful life of the particular piece of equipment.

maintenance = factor for maintenance; 0.05.

interest rate = variable, see discussion below in this proposed rule.

Usage: We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic Start Printed Page 61605 imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act.

Useful Life: In the CY 2005 PFS final rule we stated that we updated the useful life for equipment items primarily based on the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” guidelines ( 69 FR 66246 ). The most recent edition of these guidelines was published in 2018. This reference material provides an estimated useful life for hundreds of different types of equipment, the vast majority of which fall in the range of 5 to 10 years, and none of which are lower than two years in duration. We believe that the updated editions of this reference material remain the most accurate source for estimating the useful life of depreciable medical equipment.

In the CY 2021 PFS final rule, we finalized a proposal to treat equipment life durations of less than 1 year as having a duration of 1 year for the purpose of our equipment price per minute formula. In the rare cases where items are replaced every few months, we noted that we believe it is more accurate to treat these items as disposable supplies with a fractional supply quantity as opposed to equipment items with very short equipment life durations. For a more detailed discussion of the methodology associated with very short equipment life durations, we refer readers to the CY 2021 PFS final rule ( 85 FR 84482 through 84483 ).

Maintenance: We finalized the 5 percent factor for annual maintenance in the CY 1998 PFS final rule with comment period ( 62 FR 33164 ). As we previously stated in the CY 2016 PFS final rule with comment period ( 80 FR 70897 ), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also noted that we believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding data sources containing equipment maintenance rates, commenters could not identify an auditable, robust data source that CMS could use on a wide scale. We noted that we did not believe voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, we did not propose a variable maintenance factor for equipment cost per minute pricing as we did not believe that we have sufficient information at present. We noted that we would continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment period ( 77 FR 68902 ), we updated the interest rates used in developing an equipment cost per minute calculation (see 77 FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). The Interest rates are listed in Table 3.

We are not proposing any changes to the equipment interest rates for CY 2025.

In the past, we have stated that we believe that the MEI is the best measure available of the relative weights of the three components in payments under the PFS—work, practice expense (PE), and malpractice (MP). Accordingly, we believe that to ensure that the PFS payments reflect the relative resources in each of these PFS components as required by section 1848(c)(3) of the Act, the RVUs used in developing rates should reflect the same weights in each component as the cost share weights in the Medicare Economic Index (MEI). In the past, we have proposed (and subsequently finalized) to accomplish this by holding the work RVUs constant and adjusting the PE RVUs, MP RVUs, and CF to produce the appropriate balance in RVUs among the three PFS components and payment rates for individual services, that is, that the total RVUs on the PFS are proportioned to approximately 51 percent work RVUs, 45 percent PE RVUs, and 4 percent MP RVUs. As the MEI cost shares are updated, we would typically propose to modify steps 3 and 10 to adjust the aggregate pools of PE costs (direct PE in step 3 and indirect PE in step 10) in proportion to the change in the PE share in the rebased and revised MEI cost share weights, and to recalibrate the relativity adjustment that we apply in step 18 as described in the CY 2023 PFS final rule ( 87 FR 69414 and 69415 ) and CY 2014 PFS final rule ( 78 FR 74236 and 74237 ). The most recent recalibration was done for the CY 2014 RVUs.

In the CY 2014 PFS proposed rule ( 78 FR 43287 through 43288 ) and final rule ( 78 FR 74236 through 74237 ), we detailed the steps necessary to accomplish this result (see steps 3, 10, and 18). The CY 2014 proposed and final adjustments were consistent with our longstanding practice to make adjustments to match the RVUs for the PFS components with the MEI cost share weights for the components, including the adjustments described in the CY 1999 PFS final rule ( 63 FR 58829 ), CY 2004 PFS final rule ( 68 FR 63246 and 63247 ), and CY 2011 PFS final rule ( 75 FR 73275 ).

In the CY 2023 PFS final rule ( 87 FR 69688 through 69711 ), we finalized to rebase and revise the MEI to reflect more current market conditions faced by physicians in furnishing physicians' services (referred to as the “2017-based MEI”). We also finalized a delay of the adjustments to the PE pools in steps 3 Start Printed Page 61606 and 10 and the recalibration of the relativity adjustment in step 18 until the public had an opportunity to comment on the rebased and revised MEI ( 87 FR 69414 through 69416 ). Because we finalized significant methodological and data source changes to the MEI in the CY 2023 PFS final rule and significant time has elapsed since the last rebasing and revision of the MEI in CY 2014, we believed that delaying the implementation of the finalized CY 2023 rebased and revised MEI was consistent with our efforts to balance payment stability and predictability with incorporating new data through more routine updates. We refer readers to the discussion of our comment solicitation in the CY 2023 PFS final rule ( 87 FR 69429 through 69432 ), where we reviewed our ongoing efforts to update data inputs for PE to aid stability, transparency, efficiency, and data adequacy. We also solicited comment in the CY 2023 PFS proposed rule on when and how to best incorporate the CY 2023 rebased and revised MEI into PFS ratesetting, and whether it would be appropriate to consider a transition to full implementation for potential future rulemaking. We presented the impacts of implementing the rebased and revised MEI in PFS ratesetting through a 4-year transition and through full immediate implementation, that is, with no transition period in the CY 2023 PFS proposed rule. We also solicited comment on other implementation strategies for potential future rulemaking in the CY 2023 PFS proposed rule. In the CY 2023 PFS final rule, we discussed that many commenters supported our proposed delayed implementation, and many commenters expressed concerns with the redistributive impacts of the implementation of the rebased and revised MEI in PFS ratesetting. Many commenters also noted the AMA's intent to collect practice cost data from physician practices, which could be used to derive cost share weights for the MEI and RVU shares.

In light of the AMA's current data collection efforts and because the methodological and data source changes to the MEI finalized in the CY 2023 PFS final rule would have significant impacts on PFS payments, similar to our discussion of this topic in the CY 2024 PFS rulemaking cycle ( 88 FR 78829 through 78831 ), we continue to believe that delaying the implementation of the finalized 2017-based MEI cost share weights for the RVUs is consistent with our efforts to balance payment stability and predictability with incorporating new data through more routine updates. For these reasons, we did not propose to incorporate the 2017-based MEI in PFS ratesetting for CY 2024. As we noted in the CY 2024 PFS final rule, many commenters on the CY 2024 PFS proposed rule supported our continued delayed implementation of the 2017-based MEI in PFS ratesetting ( 88 FR 78830 ). Most of these commenters urged us to pause consideration of other sources for the MEI until the AMA's efforts to collect practice cost data from physician practices have concluded, although a few commenters recommended that we implement the MEI for PFS ratesetting as soon as possible. We agree with the commenters that it would be prudent, and avoid potential duplication of effort, to wait to consider other data sources for the MEI while the AMA's data collection activities are ongoing. As we discussed in the CY 2024 PFS final rule, we continue to monitor the data available related to physician services' input expenses, but we are not proposing to update the data underlying the MEI cost weights at this time. Given our previously described policy goal to balance PFS payment stability and predictability with incorporating new data through more routine updates to the MEI, we are not proposing to incorporate the 2017-based MEI in PFS ratesetting for CY 2025. We invite comments on this approach as well as any information on the timing of the AMA's practice cost data collection efforts and other sources of data we could consider for updating the MEI.

This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2025 direct PE input public use files, which are available on the CMS website under downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html .

As we noted in the CY 2015 PFS final rule with comment period ( 79 FR 67640 through 67641 ), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and post service periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve the relativity of values among codes. For example, as medical practice and technologies change over time, standards could be updated simultaneously for all codes with the applicable clinical labor tasks instead of waiting for individual codes to be reviewed.

In the CY 2016 PFS final rule with comment period ( 80 FR 70901 ), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for “Availability of prior images confirmed”, 2 minutes for “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist”, 2 minutes for “Review examination with interpreting MD”, and 1 minute for “Exam documents scanned into PACS” and “Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.” In the CY 2017 PFS final rule ( 81 FR 80184 through 80186 ), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate Start Printed Page 61607 case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values. We also finalized standard times for a series of clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period ( 80 FR 70902 ). We do not believe these activities would be dependent on number of blocks or batch size, and we believe that the finalized standard values accurately reflect the typical time it takes to perform these clinical labor tasks.

In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. We proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. Commenters explained in response that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes, and that a prior clinical labor task was split into two of the new clinical labor activity codes: CA007 ( Review patient clinical extant information and questionnaire ) in the preservice period, and CA014 ( Confirm order, protocol exam ) in the service period. Commenters stated that the same clinical labor from the old PE worksheet was now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity. We agreed with commenters that we would finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in situations where this was the case. However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include this old clinical labor task, and we also noted that several of the reviewed codes that contained the CA014 clinical labor activity code did not contain any clinical labor for the CA007 activity. In these situations, we believe that the three total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized these clinical labor refinements. We direct readers to the discussion in the CY 2019 PFS final rule ( 83 FR 59463 through 59464 ) for additional details.

Following the publication of the CY 2020 PFS proposed rule, one commenter expressed concern with the published list of common refinements to equipment time. The commenter stated that these refinements were the formulaic result of applying refinements to the clinical labor time and did not constitute separate refinements; the commenter requested that CMS no longer include these refinements in the table published each year. In the CY 2020 PFS final rule, we agreed with the commenter that these equipment time refinements did not reflect errors in the equipment recommendations or policy discrepancies with the RUC's equipment time recommendations. However, we believed it was important to publish the specific equipment times that we were proposing (or finalizing in the case of the final rule) when they differed from the recommended values due to the effect these changes can have on the direct costs associated with equipment time. Therefore, we finalized the separation of the equipment time refinements associated with changes in clinical labor into a separate table of refinements. We direct readers to the discussion in the CY 2020 PFS final rule ( 84 FR 62584 ) for additional details.

Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time, and among the medical specialties developing the recommendations. These variations have made it difficult for the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC mandated the use of a new PE worksheet for its recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations helps us simplify and standardize the hundreds of clinical labor tasks currently listed in our direct PE database. As in previous calendar years, to facilitate rulemaking for CY 2025, we are continuing to display two versions of the Labor Task Detail public use file: one version with the old listing of clinical labor tasks and one with the same tasks crosswalked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html .

In the CY 2011 PFS final rule with comment period ( 75 FR 73205 ), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in CY 2019 and continuing through CY 2022, we conducted a market-based supply and equipment pricing update using information developed by our contractor, StrategyGen, which updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. Given the potentially significant changes in payment that would occur, in the CY 2019 PFS final rule, we finalized a policy to phase in our use of the new direct PE input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy while maintaining stability and allowing interested parties to address potential concerns about changes in payment for particular items. This 4-year transition period to update supply and equipment pricing concluded in CY 2022; for a more detailed discussion, we refer readers to the CY 2019 PFS final rule with comment period ( 83 FR 59473 through 59480 ).

For CY 2025, we are proposing to update the price of 17 supplies and one equipment item in response to the public submission of invoices following the publication of the CY 2024 PFS final rule. The 18 supply and equipment items with proposed updated prices are listed in the valuation of specific codes section of the preamble under Table 16, CY 2025 Invoices Received for Existing Direct PE Inputs.

An interested party submitted 30 invoices to update pricing for the human amniotic membrane allograft Start Printed Page 61608 mounted on a non-absorbable self-retaining ring (SD248) supply. We previously updated the price of this supply in the CY 2024 final rule ( 88 FR 78901 ) based on averaging together the price of the Prokera Slim, Prokera Classic, and Prokera Plus devices. The interested party submitted new invoices for all three of these devices which averaged to a new price of $1149.00 which we are proposing for the SD248 supply. We are soliciting additional comments from interested parties regarding the price of the SD248 supply as well as any information as far as whether one of these three devices (the Prokera Slim, Prokera Classic, and Prokera Plus) would be more typical than the other two for use as a supply in CPT code 65778.

In the case of the indocyanine green (25ml uou) (SL083) supply, we noticed that there was a clear bimodal distribution of prices on the eight submitted invoices, clustered around $91.00 and $141.67, respectively, with no pricing in between $100 and $140. We are proposing the updated total average price of $125.11 based on the eight submitted invoices for the SL083 supply, however, we are soliciting comments on why there was such divergence in the pricing on the submitted invoices, as well as whether these may represent pricing for two different supplies.

Regarding the Reaction buffer 10X (Ventana 950-300) (SL478) supply, we are proposing to update the price from $0.037 to $0.045, which is less than the $0.075 contained on the invoice submitted by interested parties. We were able to find this product readily available for purchase online at a quantity of 10 liters for $453 or a price of $0.045. We do not believe that it would be typical for providers to pay a higher price based on smaller unit quantities; therefore, we are proposing to update the price of the SL478 supply but only to $0.045, which is the price to purchase this supply online, as stated above.

Interested parties also alerted CMS to a technical correction for pricing the Atomizer tips (disposable) (SL464) supply. We previously finalized a price of $2.66 for the SL464 supply, which was included in the table of Invoices Received for Existing Direct PE Inputs in the CY 2018 final rule ( 82 FR 53162 ). However, due to a technical error, the updated pricing for the SL464 supply was never implemented. We are proposing to make this correction for CY 2025; the corrected price of $2.66 for the SL464 supply is included in Table 16.

We are not proposing to update the price of another ten supplies, which were the subject of public submission of invoices. Our reasons for not proposing updates to these prices are detailed below, and we are seeking additional information from interested parties for assistance in pricing these supplies:

Liposorber supplies: Tubing set (SC083), Plasma LDL adsorption column (SD186), and Plasma separator (SD188): We received invoices for these three Liposorber supplies from an interested party. However, it was unclear from the invoice submissions what the unit quantity size is for each product. We require additional information regarding the unit size of each supply included on these invoices to establish updated pricing, and therefore, we are not proposing updates to the prices for these supplies. We are seeking additional comments regarding the pricing of these supplies and whether the pricing has increased so dramatically, as it seems unlikely that prices have tripled in the five years since we most recently updated the pricing for these supplies.
Congo Red kits (SA110): We received three invoices from interested parties requesting an increase in the price of the SA110 supply from $6.80 to $18.78. However, we were able to find Congo Red staining kits readily available online at a price of 100 for $410 or $4.10 per kit. The unit size of these kits was also unclear, which made price comparisons with the submitted invoices difficult. Based on the three invoices and the online price of 100 for $410 or $4.10 per kit, we do not believe there is enough pricing data to support an increase in the price of the SA110 supply from $6.80 to $18.78, and we are not proposing an increase in the price of this supply.
Gauze, non-sterile 4in x 4in (SG051): We received one invoice from interested parties requesting an increase in the price of the SG051 supply from $0.03 to $0.04. However, the submitted invoice price appeared to be for surgical gauze, not non-sterile gauze. We were able to find the 4x4 non-sterile gauze readily available online at less than the invoice price. Based on this information, we do not believe there is enough pricing data to support an increase in the price of the SG051 supply from $0.03 to $0.04, and we are not proposing an increase in the price of this supply.
Permanent marking pen (SL477): We received one invoice from interested parties requesting an increase in the price of the SL477 supply from $2.81 to $4.62. However, we found black marking pens, such as Sharpies, widely available at unit prices around $2.00 when purchased in larger quantities. Based on this information, we do not believe there is enough pricing data to support an increase in the price of the SL477 supply from $2.81 to $4.62, and we are not proposing an increase in the price of this supply.
Hematoxylin II (Ventana 790-2208) (SL483): We received four invoices from interested parties requesting an increase in the price of the SL483 supply from $0.780 to $2.722. However, we were able to find hematoxylin II stains readily available online at cheaper prices, such as $52.00 for 500 ml ($0.104 per ml). Based on this information, we do not believe there is enough pricing data to support an increase in the price of the SL483 supply from $0.780 to $2.722, and we are not proposing an increase in the price of this supply.
Bluing reagent (Ventana 760-2037) (SL484): We received three invoices from interested parties requesting an increase in the price of the SL484 supply from $4.247 to $6.130. While researching the pricing of the SL484 supply, we were unable to determine the unit quantity size on invoices, which made it difficult to evaluate if the requested price accurately reflected market pricing. As best we could tell, the requested price increase to $6.130 was more expensive than comparable online bluing reagents available for purchase. Based on this information, we do not believe there is enough pricing data to support an increase in the price of the SL484 supply from $4.247 to $6.130, and we are not proposing an increase in the price of this supply.
EZ Prep (10X) (Ventana 950-102) (SL481) and 250 Test Prep Kit # 78 (Ventana 786-3034) (SL486): In each of these cases, we received invoices from interested parties requesting substantial increases in the price of the associated supplies, from $0.034 to $0.509 for the SL481 supply and from $0.309 to $2.134 for the SL486 supply. We do not believe that it is reasonable to expect that the typical market prices for these supplies have increased by 1400 percent and 600 percent, respectively, in the 5 years since we most recently updated the pricing for these supplies. The limited pricing information we could find online for each product also failed to support these drastic increases in pricing. Based on this information, we do not believe there is enough pricing data to support the requested increases for the SL481 and SL486 supplies, and we are not proposing increases to the prices for these supplies.

We remind readers that we routinely accept public submissions of invoices as part of our process for developing payment rates for new, revised, and Start Printed Page 61609 potentially misvalued codes. Often, these invoices are submitted in conjunction with the RUC-recommended values for the codes. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we will consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices. Interested parties are encouraged to submit invoices with their public comments or, if outside the notice and comment rulemaking process, via email at [email protected] .

In recent years, we have noticed a growing number of invoice submissions for use in updating supply and equipment pricing. Although we continue to believe in the importance of using the most recent and accurate invoice data to reflect current market pricing, we do have some concerns that the increased use of these submissions may distort relativity across the fee schedule. Relying on voluntary invoice submissions to update pricing for a small subset of the total number of supply and equipment items in our database, while leaving the overwhelming majority of prices untouched, could be distorting pricing in favor of the most recent submissions. We believe that it may be more efficient, and more accurate, to update supply and equipment pricing in a more comprehensive fashion similar to the pricing update that took place from CY 2019 to CY 2022. For example, future updates to supply and equipment pricing could take place in tandem with updates to clinical labor pricing after the current clinical labor update concludes in CY 2025. We welcome public comments on this general topic of more comprehensive updates to supply and equipment pricing, and we may consider comments we receive to inform future rulemaking.

Interested parties previously notified CMS that they identified numerous discrepancies between the aggregated cost of some supply packs and the individual item components contained within. The interested parties indicated that CMS should rectify these mathematical errors as soon as possible to ensure that the sum correctly matches the totals from the individual items, and they recommended that we resolve these pricing discrepancies in the supply packs during CY 2024 rulemaking. The AMA RUC convened a workgroup on this subject and submitted recommendations to update pricing for a series of supply packs along with the RUC's comment letter for the CY 2024 rule cycle.

We appreciated the additional information and RUC workgroup recommendations regarding discrepancies in the aggregated cost of some supply packs. However, due to the projected significant cost revisions in the pricing of supply packs and because we did not propose to address supply pack pricing in the CY 2024 proposed rule, we stated that this issue would be better addressed in future rulemaking. For example, the cleaning and disinfecting endoscope pack (SA042) is included as a supply input in more than 300 HCPCS codes, which could have a sizable impact on the overall valuation of these services, and which was not incorporated into the proposed RVUs published for the CY 2024 proposed rule. We stated that interested parties would be better served if we comprehensively addressed this topic during future rulemaking in which commenters could provide feedback in response to proposed pricing updates ( 88 FR 78833 through 78834 ).

For CY 2025, we are proposing to implement the supply pack pricing update and associated revisions as recommended by the RUC's workgroup. We are proposing to update the pricing of the “pack, cleaning and disinfecting, endoscope” (SA042) supply from $19.43 to $31.29, to update the pricing of the “pack, drapes, cystoscopy” (SA045) supply from $17.33 to $14.99, to update the pricing of the “pack, ocular photodynamic therapy” (SA049) supply from $16.35 to $26.35, to update the pricing of the “pack, urology cystoscopy visit” (SA058) supply from $113.70 to $37.63, and to update the pricing of the “pack, ophthalmology visit (w-dilation)” (SA082) supply from $3.91 to $2.33. As recommended by the RUC workgroup, we are also proposing to delete the “pack, drapes, laparotomy (chest-abdomen)” (SA046) supply entirely. The proposed updated prices for these supply packs are listed in the valuation of specific codes section of the preamble under Table 16, CY 2025 Invoices Received for Existing Direct PE Inputs.

In accordance with the RUC workgroup's recommendations, we are also proposing to create eight new supply codes, including components contained within previously existing supply packs. Aside from the SB056 supply, which is a replacement in several HCPCS codes for the deleted SA046 supply pack, all of these new supplies are not included as standalone direct PE inputs in any current HCPCS codes, as they are, again, components contained within previously existing supply packs. We are proposing to add:

The kit, ocular photodynamic therapy (PDT) (SA137) supply at a price of $26.00 as a component of the SA049 supply pack;
The Abdominal Drape Laparotomy Drape Sterile (100 in x 72 in x 124 in) (SB056) supply at a price of $8.049 as a replacement for the SA046 supply pack;
The drape, surgical, legging (SB057) supply at a price of $3.284 as a component of the SA045 supply pack;
The drape, surgical, split, impervious, absorbent (SB058) supply at a price of $8.424 as a component of the SA045 supply pack;
The post-mydriatic spectacles (SB059) supply at a price of $0.328 as a component of the SA082 supply pack;
The y-adapter cap (SD367) supply at a price of $0.352 as a component of the SA049 supply pack;
The ortho-phthalaldehyde 0.55% ( e.g., Cidex OPA) (SM030) supply at a price of $0.554 as a component of the SA042 supply pack; and
The ortho-phthalaldehyde test strips (SM031) supply at a price of $1.556 as a component of the SA042 supply pack.

The proposed new supply pack component items are listed in the valuation of specific codes section of the preamble under Table 17, CY 2025 New Invoices.

We are also proposing the following additional supply substitutions based on the recommendations of the RUC workgroup. We are proposing to remove the deleted SA046 supply pack and replace it with the drape, sterile, fenestrated 16in x 29in (SB011) supply for CPT codes 19020, 19101, 19110, 19112, 20101, and 20102. We are proposing to remove the deleted SA046 supply pack and replace it with two supplies—the drape, sterile, three-quarter sheet (SB014) and the drape, towel, sterile 18in x 26in (SB019)—for CPT codes 19000 and 60300. We are proposing to remove the deleted SA046 supply pack and replace it with two supplies—the drape, towel, sterile 18in × 26in (SB019) and the newly created Abdominal Drape Laparotomy Drape Sterile (100 in × 72 in × 124 in) (SB056) supply—for CPT codes 22510, 22511, 22513, and 22514. We are proposing to remove the deleted SA046 supply pack without replacing it with anything for CPT code 22526; the RUC workgroup Start Printed Page 61610 did not make a recommendation on what to do with CPT code 27278, which also previously contained the SA046 supply pack. Therefore, we are also proposing not to replace the SA046 supply pack with any supplies for this code. The RUC workgroup also recommended removing the SA046 supply pack from CPT code 64595 with no replacement; however, this code was recently reviewed at the April 2022 RUC meeting and it no longer includes the SA046 supply.

The RUC workgroup also reviewed the issue of skin adhesives and identified several generic alternatives to using the skin adhesive (Dermabond) (SG007) supply. The workgroup stated that there are multiple skin adhesive products, at different price points, available that work similarly to Dermabond and requested that generic alternatives be used overall in place of brand names in the CMS direct PE database. The workgroup made a series of suggestions for CMS to create new medical supply item codes to encompass the generic formulations of cyanoacrylate skin adhesive in multidose form and single use sterile application.

We appreciate the recommendations from the RUC workgroup and concur that generic alternatives be used in place of brand names, where appropriate, in the CMS direct PE database. However, we have no pricing information or submitted invoices for the four generic formulations of cyanoacrylate skin adhesive requested by the RUC workgroup (2-Octyl-cyanoacrylate, n-Butyl-2-cyanoacrylate, Combined n-Butyl and 2-Octylcyanoacrylate, and Ethyl-2-cyanoacrylate). Since these four potential new supplies have no pricing information and are not currently included as direct PE inputs for any HCPCS codes, we have not added them to our direct PE database for the CY 2025 proposed rule due to lack of available information.

Section 220(a) of the PAMA provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types, and prices of PE inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS.

Beginning in CY 2019, we updated the supply and equipment prices used for PE as part of a market-based pricing transition; CY 2022 was the final year of this 4-year transition. We initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the supply and equipment pricing for CY 2019, and we finalized a policy in CY 2019 to phase in the new pricing over a period of 4 years. However, we did not propose to update the clinical labor pricing, and the pricing for clinical labor has remained unchanged during this pricing transition. Clinical labor rates were last updated for CY 2002 using Bureau of Labor Statistics (BLS) data and other supplementary sources where BLS data were not available; we refer readers to the full discussion in the CY 2002 PFS final rule for additional details ( 66 FR 55257 through 55262 ).

Interested parties raised concerns that the long delay since clinical labor pricing was last updated created a significant disparity between CMS' clinical wage data and the market average for clinical labor. In recent years, several interested parties suggested that certain wage rates were inadequate because they did not reflect current labor rate information. Some interested parties also stated that updating the supply and equipment pricing without updating the clinical labor pricing could create distortions in the allocation of direct PE. They argued that since the pool of aggregated direct PE inputs is budget neutral, if these rates are not routinely updated, clinical labor may become undervalued over time relative to equipment and supplies, especially since the supply and equipment prices are in the process of being updated. There was considerable interest among interested parties in updating the clinical labor rates, and when we solicited comment on this topic in past rules, such as in the CY 2019 PFS final rule ( 83 FR 59480 ), interested parties supported the idea.

Therefore, we proposed to update the clinical labor pricing for CY 2022, in conjunction with the final year of the supply and equipment pricing update ( 86 FR 39118 through 39123 ). We believed updating the clinical labor pricing was important to maintain relativity with the recent supply and equipment pricing updates. We proposed to use the methodology outlined in the CY 2002 PFS final rule ( 66 FR 55257 ), which draws primarily from BLS wage data, to calculate updated clinical labor pricing. As we stated in the CY 2002 PFS final rule, the BLS' reputation for publishing valid estimates that are nationally representative led to the choice to use the BLS data as the main source. We believe that the BLS wage data continues to be the most accurate source to use as a basis for clinical labor pricing and this data will appropriately reflect changes in clinical labor resource inputs for setting PE RVUs under the PFS. We used the most current BLS survey data (2019) as the main source of wage data for our CY 2022 clinical labor proposal.

We recognized that the BLS survey of wage data does not cover all the staff types contained in our direct PE database. Therefore, we crosswalked or extrapolated the wages for several staff types using supplementary data sources for verification whenever possible. In situations where the price wages of clinical labor types were not referenced in the BLS data, we used the national salary data from the Salary Expert, an online project of the Economic Research Institute that surveys national and local salary ranges and averages for thousands of job titles using mainly government sources. (A detailed explanation of the methodology used by Salary Expert to estimate specific job salaries can be found at www.salaryexpert.com . ) We previously used Salary Expert information as the primary backup source of wage data during the last update of clinical labor pricing in CY 2002. If we did not have direct BLS wage data available for a clinical labor type, we used the wage data from Salary Expert as a reference for pricing, then crosswalked these clinical labor types to a proxy BLS labor category rate that most closely matched the reference wage data, similar to the crosswalks used in our PE/HR allocation. For example, there is no direct BLS wage data for the Mammography Technologist (L043) clinical labor type; we used the wage data from Salary Expert as a reference and identified the BLS wage data for Respiratory Therapists as the best proxy category. We calculated rates for the “blend” clinical labor categories by combining the rates for each labor type in the blend and then dividing by the total number of labor types in the blend.

As in the CY 2002 clinical labor pricing update, the proposed cost per minute for each clinical staff type was derived by dividing the average hourly wage rate by 60 to arrive at the per minute cost. In cases where an hourly wage rate was not available for a clinical staff type, the proposed cost per minute for the clinical staff type was derived by Start Printed Page 61611 dividing the annual salary (converted to 2021 dollars using the Medicare Economic Index) by 2080 (the number of hours in a typical work year) to arrive at the hourly wage rate and then again by 60 to arrive at the per minute cost. We ultimately finalized the use of median BLS wage data instead of mean BLS wage data in response to comments in the CY 2022 PFS final rule. To account for the employers' cost of providing fringe benefits, such as sick leave, we finalized a benefits multiplier of 1.296 based on a BLS release from June 17, 2021 (USDL-21-1094). As an example of this process, for the Physical Therapy Aide (L023A) clinical labor type, the BLS data reflected a median hourly wage rate of $12.98, which we multiplied by the 1.296 benefits modifier and then divided by 60 minutes to arrive at the finalized per-minute rate of $0.28.

After considering the comments on our CY 2022 proposals, we agreed with commenters that the use of a multi-year transition would help smooth out the changes in payment resulting from the clinical labor pricing update, avoiding potentially disruptive changes in payment for affected interested parties, and promoting payment stability from year-to-year. We believed it would be appropriate to use a 4-year transition, as we have for several other broad-based updates or methodological changes. While we recognized that using a 4-year transition to implement the update means that we will continue to rely in part on outdated data for clinical labor pricing until the change is fully completed in CY 2025, we agreed with the commenters that these significant updates to PE valuation should be implemented in the same way, and for the same reasons, as for other major updates to pricing such as the recent supply and equipment update. Therefore, we finalized the clinical labor pricing update implementation over four years to transition from current prices to the final updated prices in CY 2025. We finalized the implementation of this pricing transition over 4 years, such that one-quarter of the difference between the current price and the fully phased-in price is implemented for CY 2022, one-third of the difference between the CY 2022 price and the final price is implemented for CY 2023, and one-half of the difference between the CY 2023 price and the final price is implemented for CY 2024, with the new direct PE prices fully implemented for CY 2025. ( 86 FR 65025 ) An example of the transition from the current to the fully-implemented new pricing that we finalized in the CY 2022 PFS final rule is provided in Table 4.

(1) CY 2023 Clinical Labor Pricing Updates

For CY 2023, we received information from one interested party regarding the pricing of the Histotechnologist (L037B) clinical labor type. The interested party provided data from the 2019 Wage Survey of Medical Laboratories which supported an increase in the per-minute rate from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This rate of $0.64 for the L037B clinical labor type is a close match to the online salary data that we had for the Histotechnologist and matches the $0.64 rate that we initially proposed for L037B in the CY 2022 PFS proposed rule. Based on the wage data provided by the commenter, we proposed this $0.64 rate for the L037B clinical labor type for CY 2023; we also proposed a slight increase in the pricing for the Lab Tech/Histotechnologist (L035A) clinical labor type from $0.55 to $0.60 as it is a blend of the wage rate for the Lab Technician (L033A) and Histotechnologist clinical labor types. We also proposed the same increase to $0.60 for the Angio Technician (L041A) clinical labor type, as we previously established a policy in the CY 2022 PFS final rule that the pricing for the L041A clinical labor type would match the rate for the L035A clinical labor type ( 86 FR 65032 ).

Based on comments received on the CY 2023 proposed rule, we finalized a change in the descriptive text of the L041A clinical labor type from “Angio Technician” to “Vascular Interventional Technologist”. We also finalized an update in the pricing of three clinical labor types: from $0.60 to $0.84 for the Vascular Interventional Technologist (L041A), from $0.63 to $0.79 for the Mammography Technologist (L043A), and from $0.76 to $0.78 for the CT Technologist (L046A) based on submitted wage data from the 2022 Radiologic Technologist Wage and Salary Survey ( 87 FR 69422 through 69425 ).

(2) CY 2024 Clinical Labor Pricing Updates

We did not receive new wage data or other additional information for use in clinical labor pricing from interested parties prior to the publication of the CY 2024 PFS proposed rule. Therefore, our proposed clinical labor pricing for CY 2024 was based on the clinical labor pricing that we finalized in the CY 2023 PFS final rule, incremented an additional step for Year 3 of the update. Based on comments received on the CY 2024 proposed rule, we finalized an update in the clinical labor pricing of the cytotechnologist (L045A) clinical labor type from $0.76 to $0.85 based on submitted data from the 2021 American Society of Clinical Pathologists (ASCP) Wage Survey of Medical Laboratories ( 88 FR 78838 ).

(3) CY 2025 Clinical Labor Pricing Update Proposals

We did not receive new wage data or other additional information for use in clinical labor pricing from interested parties prior to the publication of the CY 2025 PFS proposed rule. Therefore, our proposed clinical labor pricing for CY 2025 in Table 5 is based on the clinical labor pricing that we finalized in the CY 2024 PFS final rule, incremented an additional step for the final Year 4 of the update:

As was the case for the market-based supply and equipment pricing update, the clinical labor rates will remain open for public comment during the 60-day comment period for this CY 2025 PFS proposed rule. We expect to set the updated clinical labor rates for CY 2025 in the final rule. We updated the pricing of some clinical labor types in the CY 2022, CY 2023, and CY 2024 PFS final rules in response to information provided by commenters. For the full discussion of the clinical labor pricing update, we direct readers to the CY 2022 PFS final rule ( 86 FR 65020 through 65037 ).

The AMA PPIS was first introduced in 2007 as a means to collect comprehensive and reliable data on the direct and indirect PEs incurred by physicians ( 72 FR 66222 ). In considering the use of PPIS data, the goal was to improve the accuracy and consistency of PE RVUs used in the PFS. The data collection process included a stratified random sample of physicians across various specialties, and the survey was administered between August 2007 and March 2008. Data points from that period of time are integrated into PFS calculations today. In the CY 2009 PFS proposed rule ( 73 FR 38507 through 3850 ), we discussed the indirect PE methodology that used data from the AMA's survey that predated the PPIS. In CY 2010 PFS rulemaking, we announced our intent to incorporate the AMA PPIS data into the PFS ratesetting process, which would first affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-year transition period, during which we would phase in the AMA PPIS data, replacing the existing PE data sources ( 74 FR 33554 ). We also explained that our proposals intended to update survey data only ( 74 FR 33530 through 33531 ). In our CY 2010 final rule, we finalized our proposal, with minor adjustments based on public comments ( 74 FR 61749 through 61750 ). We responded to the comments we received about the transition to using the PPIS to inform indirect PE allocations ( 74 FR 61750 ). In the responses, we acknowledged concerns about potential gaps in the data, which could impact the allocation of indirect PE for certain physician specialties and suppliers, which are issues that remain important today. The CY 2010 PFS final rule explains that section 212 of the Balanced Budget Refinement Act of 1999 ( Pub. L. 106-113 , November 29, 1999) (BBRA) directed the Secretary to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. BBRA required us to establish criteria for accepting supplemental survey data. Since the supplemental surveys were specific to individual specialties and not part of a comprehensive multispecialty survey, we had required that certain precision levels be met in order to ensure that the supplemental data was sufficiently valid, and acceptable for use in the development of the PE RVUs. At the time, our rationale included the assumption that because the PPIS is a contemporaneous, consistently collected, and comprehensive multispecialty survey, we do not believe similar precision requirements are necessary, and we did not propose to establish them for the use of the PPIS data ( 74 FR 61742 ). We noted potential gaps in the data, which could impact the allocation of indirect PE for certain physician and suppliers. The CY 2010 final rule adopted the proposal, with minor adjustments based on public comments, and explained that these minor adjustments were in part due to non-response bias that results when the characteristics of survey respondents differ in meaningful ways, such as in the mix of practices sizes, from the general population ( 74 FR 61749 through 61750 ).

Throughout the 4-year transition period, from CY 2010 to CY 2013, we gradually incorporated the AMA PPIS data into the PFS rates, replacing the previous data sources. The process involved addressing concerns and making adjustments as necessary, such as refining the PFS ratesetting methodology in consideration of interested party feedback. For background on the refinements that we considered after the transition began, we refer readers to discussions in the CY 2011 through 2014 final rules ( 75 FR 73178 through 73179 ; 76 FR 73033 through 73034 ; 77 FR 98892 ; 78 FR 74272 through 74276 ).

In the CY 2011 PFS proposed rule, we requested comments on the methodology for calculating indirect PE RVUs, explicitly seeking input on using survey data, allocation methods, and potential improvements ( 75 FR 40050 ). In our CY 2011 PFS final rule, we addressed comments regarding the methodology for indirect PE calculations, focusing on using survey data, allocation methods, and potential improvements ( 75 FR 73178 through 73179 ). We recognized some limitations of the current PFS ratesetting methodology but maintained that the approach was the most appropriate at the time. In the CY 2012 PFS final rule, we responded to comments related to indirect PE methodology, including concerns about allocating indirect PE to specific services and using the AMA PPIS data for certain specialties ( 76 FR 73033 through 73034 ). We indicated that CMS would continue to review and refine the methodology and work with interested parties to address their concerns. In the CY PFS 2014 final rule, we responded to comments about fully implementing the AMA PPIS data. By 2014, the AMA PPIS data had been fully integrated into the PFS, serving as the primary source for determining indirect PE inputs ( 78 FR 74235 ). We continued to review data and the PE methodology annually, considering interested party feedback and evaluating the need for updates or refinements to ensure the accuracy and relevance of PE RVUs ( 79 FR 67548 ). In the years following the full implementation of the AMA PPIS data, we further engaged with interested parties, thought leaders and subject matter experts to improve our PE inputs' accuracy and reliability. For further background, we refer readers to our discussions in final rules for CY 2016 through 2022 ( 80 FR 70892 ; 81 FR 80175 ; 82 FR 52980 through 52981 ; 83 FR 59455 through 59456 ; 84 FR 62572 ; 85 FR 84476 through 84478 ; 86 FR 62572 ).

In our CY 2023 PFS final rule, we issued an RFI to solicit public comment Start Printed Page 61614 on strategies to update PE data collection and methodology ( 87 FR 69429 through 69432 ). We solicited comments on current and evolving trends in health care business arrangements, the use of technology, or similar topics that might affect or factor into PE calculations. We reminded readers that we have worked with interested parties and CMS contractors for years to study the landscape and identify possible strategies to reshape the PE portion of physician payments. The fundamental issues are clear but thought leaders and subject matter experts have advocated for more than one tenable approach to updating our PE methodology.

As described in previous rulemaking, we have continued interest in developing a roadmap for updates to our PE methodology that account for changes in the health care landscape. Of various considerations necessary to form a roadmap for updates, we reiterate that allocations of indirect PE continue to present a wide range of challenges and opportunities. As discussed in multiple cycles of previous rulemaking, our PE methodology relies on AMA PPIS data, which may represent the best aggregated available source of information at this time. However, we acknowledge the limitations and challenges interested parties have raised about using the current data for indirect PE allocations, which we have also examined in related ongoing research. We noted in our CY 2023 and CY 2024 rules that there are several competing concerns that CMS must take into account when considering updated data sources, which also should support and enable ongoing refinements to our PE methodology.

In the CY 2024 PFS proposed rule, we continued to encourage interested parties to provide feedback and suggestions to CMS that give an evidentiary basis to shape optimal PE data collection and methodological adjustments over time. Considering our ratesetting methodology and prior experiences implementing new data, we issued a follow-up from the CY 2023 comment solicitation for general information. We solicited comments from interested parties on strategies to incorporate information that could address known challenges we experienced in implementing the initial AMA PPIS data. Our current methodology relies on the AMA PPIS data, legislatively mandated supplemental data sources (for, example, we use supplemental survey data collected in 2003, as required by section 1848(c)(2)(H)(i) of the Act to set rates for oncology and hematology specialties), and in some cases crosswalks to allocate indirect PE as necessary for certain specialties and provider types. We also sought to understand whether, upon completion of the updated PPIS data collection effort by the AMA, contingencies or alternatives may be necessary and available to address the lack of data availability or response rates for a given specialty, set of specialties, or specific service suppliers who are paid under the PFS.

In response to last year's RFI, most commenters stated that CMS should defer significant changes until the AMA PPIS results become available. For further background, refer to 88 FR 78841 to 78843. In responding to our RFI, the AMA RUC provided a set of responses, which many other commenters repeated in their separate, individual comments. In summary, the AMA RUC letter submission from CY 2024 suggested that CMS should not consider further changes until PPIS data collection and analysis is complete. Overall, the AMA comments generally do not support any change to the methodology and stated that CMS should wait to consider any further changes until PPIS updates become available. Further, we noted that through its contractor, Mathematica, the AMA secured an endorsement for the PPIS updates from each State society, national medical specialty society, and others prior to fielding the survey ( 88 FR 78843 ). Refer to the AMA's summary of the PPIS, available at https://www.ama-assn.org/system/files/physician-practice-information-survey-summary.pdf . The AMA expects analysis, reporting, and documentation to complete by the end of CY 2024, and the AMA would share data with CMS when results become available.

We believe the AMA's approach may possibly mitigate nonresponse bias, which created challenges using previous PPIS data. However, we remain uncertain about whether endorsements prior to fielding the survey may inject other types of bias in the validity and reliability of the information collected. We believe it remains important to reflect on the challenges with our current methodology, and to continue to consider alternatives that improve the stability and accuracy of our overall PE methodology. We reiterate our discussion summarizing the responses to previous years' RFIs in each of the CY 2023 and CY 2024 final rules (refer to 87 FR 69429 through 69432 and 88 FR 78841 to 78843). We have started new work under contract with the RAND Corporation to analyze and develop alternative methods for measuring PE and related inputs for implementation of updates to payment under the PFS. We continue to study possible alternatives, and would include analysis of updated PPIS data, as part of our ongoing work. In the meantime, we request general information from the public on ways that CMS may continue work to improve the stability and predictability of any future updates. Specifically, we request feedback from interested parties regarding scheduled, recurring updates to PE inputs for supply and equipment costs.

We believe that establishing a cycle of timing to update supply and equipment cost inputs every 4 years may be one means of advancing shared goals of stability and predictability. CMS would collect available data, including, but not limited to, submissions and independent third-party data sources, and propose a phase-in period over the following 4 years. The phase-in approach maps to our experience with previous updates. Additionally, we believe that more frequent updates may have the unintended consequence of disproportionate effects of various supplies and equipment that have newly updated costs.

Further, we seek feedback on possible mechanisms to establish a balance whereby our methodology would account for inflation and deflation in supply and equipment costs. We remain uncertain how economies of scale (meaning a general principle that cost per unit of production decreases as the scale of production increases) should or should not factor into future adjustments to our methodology. There remains a diversity of perspectives among interested parties about such effects. We seek information about specific mechanisms that may be appropriate, and in particular, approaches that would leverage verifiable and independent, third-party data that is not managed or controlled by active market participants.

Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the relative value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using Start Printed Page 61615 certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.

As discussed in section II.E. of this proposed rule, under Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association (AMA) Resource-Based Relative Value Scale (RBRVS) Update Committee (RUC), MedPAC, and other interested parties. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by statute. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as the Veterans Health Administration (VHA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other interested parties such as from the general medical-related community and the public. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.

In its March 2006 Report to the Congress ( https://www.medpac.gov/document/report-to-the-congress-2006-medicare-payment-policy/ ), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE costs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases, or PE costs rise.

As MedPAC noted in its March 2009 Report to Congress ( https://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf ), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:

Codes that have experienced the fastest growth.
Codes that have experienced substantial changes in PE.
Codes that describe new technologies or services within an appropriate time-period (such as 3 years) after the relative values are initially established for such codes.
Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.
Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
Codes that have not been subject to review since implementation of the fee schedule.
Codes that account for the majority of spending under the PFS.
Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
Codes for which there may be a change in the typical site of service since the code was last valued.
Codes for which there is a significant difference in payment for the same service between different sites of service.
Codes for which there may be anomalies in relative values within a family of codes.
Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
Codes with high intraservice work per unit of time.
Codes with high PE RVUs.
Codes with high cost supplies.
Codes as determined appropriate by the Secretary.

Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using current processes for consideration of coding changes), which may involve consolidating individual services into bundled codes for payment under the PFS.

To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially Start Printed Page 61616 misvalued codes established in the CY 2012 PFS final rule with comment period ( 76 FR 73026 , 73058 through 73059 ), other individuals and groups submit nominations for review of potentially misvalued codes as well. Individuals and groups may submit codes for review under the potentially misvalued codes initiative to CMS in one of two ways. Nominations may be submitted to CMS via email or through postal mail. Email submissions should be sent to the CMS emailbox at [email protected] , with the phrase “Potentially Misvalued Codes” and the referencing CPT code number(s) and/or the CPT descriptor(s) in the subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the Centers for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination letters must be labeled “Attention: Division of Practitioner Services, Potentially Misvalued Codes.” Nominations for consideration in our next annual rule cycle should be received by our February 10th deadline. Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed over 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period ( 76 FR 73052 through 73055 ). In the same CY 2012 PFS final rule with comment period, we finalized our policy to consolidate the review of physician work and PE at the same time and established a process for the annual public nomination of potentially misvalued services.

In the CY 2013 PFS final rule with comment period ( 77 FR 68892 , 68896 through 68897 ), we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes” [ 1 ] ). In the CY 2019 PFS proposed rule ( 73 FR 38589 ), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review of Work RVUs proposed rule ( 76 FR 32410 , 32419 ), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time). We continue each year to consider and finalize a list of potentially misvalued codes that have or will be reviewed and revised as appropriate in future rulemaking.

In the CY 2012 PFS final rule with comment period ( 76 FR 73058 ), we finalized a process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule with comment period ( 79 FR 67548 , 67606 through 67608 ), we modified this process whereby the public and interested parties may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:

Documentation in peer reviewed medical literature or other reliable data that demonstrate changes in physician work due to one or more of the following: technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data).
National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.

We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In each year's final rule, we finalize our list of potentially misvalued codes.

In each proposed rule, we seek nominations from the public and from interested parties of codes that they believe we should consider as potentially misvalued. We receive public nominations for potentially misvalued codes by February 10th and we display these nominations on our public website, where we include the submitter's name, their associated organization, and the submitted studies for full transparency. We sometimes receive submissions for specific, PE-related inputs for codes, and discuss these PE-related submissions, as necessary under the Determination of PE RVUs section of the rule. We summarize below this year's submissions under the potentially misvalued code initiative. For CY 2025, we received 5 nominations concerning various codes. The nominations are as follows:

An interested party nominated CPT codes 22210 ( Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; cervical ) (090 day global code), 22212 ( Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; thoracic ) (090 day global code), 22214 ( Osteotomy of spine, posterior or posterolateral approach, 1 vertebral segment; lumbar ) (090 day global code), and 22216 ( Osteotomy of Start Printed Page 61617 spine, posterior or posterolateral approach, 1 vertebral segment; each additional vertebral segment (List separately in addition to primary procedure) (add-on ZZZ) as potentially misvalued for six reasons: (1) incorrect global period; (2) incorrect inpatient days; (3) incorrect intraservice work description; (4) overvalued intraservice times; (5) changed surgical practice; and (6) incorrect use of posterior osteotomy codes. The posterior osteotomy codes were last valued by the RUC in 1995. Currently, CPT code 22210 has a work RVU of 25.38, CPT code 22212 has a work RVU of 20.99, CPT code 22214 has a work RVU of 21.02, and CPT code 22216 has a work RVU of 6.03. CPT codes 22210, 22212, and 22214 have 7 inpatient days each, while CPT code 22216 has 0 inpatient days, and it is an add-on code.

First, the nominator stated that these posterior osteotomies are always performed as an optional addition to a spinal fusion and should be valued as add-on services and not as 90-day global services. We note that no references are provided to support the statement that the service is always performed as an optional addition to a spinal fusion. Second, the nominator explained that the average hospital stay for scoliosis fusion with osteotomy is 4 to 5 days according to the current literature, [ 2 3 4 ] in contrast with the currently included 7 inpatient days. We note that the majority of the medical literature submitted by the nominator presented outcome information on adolescent patients, which may be different from the Medicare population. Furthermore, the nominator stated that the intraservice work description for CPT code 22216 describes removal of the pedicle, which is not a typical part of a Ponte/Schwab II osteotomy. Among the posterior osteotomy codes, only CPT code 22216 had vignettes and we do not have information to decide whether the code descriptor is correct. We believe this issue would benefit from further review by the medical community and welcome comments and considerations, including from the AMA CPT.

The nominator also asserted that intraservice times were too high, particularly for these osteotomy services furnished with scoliosis fusion procedures. The nominator explained that a typical scoliosis fusion would be billed with an intraservice time of up to 840 minutes for pediatric scoliosis fusion and 915 minutes for adult cases. However, referencing current literature, they observed that a typical scoliosis fusion in a child requires approximately 278 minutes (243-296 minutes), [ 5 6 7 ] which contrasts significantly with the durations indicated for the current codes. The nominator provided no studies to support a typical scoliosis fusion time in adults. Drawing from the literature, the nominators assert that intraservice times are overvalued for these services and propose that these times should be adjusted to align more closely with average and/or typical surgery times.

The nominator further asserted that this code family is potentially misvalued because surgical practice for these procedures has evolved since 1995. Approximately 30 years ago, osteotomies were infrequently performed and usually reserved for addressing completely ankylosed or fused spinal segments. [ 8 ] However, according to the nominator, contemporary surgical techniques often involve posterior osteotomies to release multiple stiff vertebral segments, thereby enhancing coronal correction and reducing thoracic hypokyphosis. In addition to changes in surgical techniques over time, there are notable shifts in the trends regarding the utilization of osteotomies. For instance, between 2007 and 2015, the use of posterior osteotomies in scoliosis cases nearly doubled, increasing from 17 percent to 35 percent. [ 9 ] Additionally, 73 percent of patients undergoing scoliosis surgery received posterior osteotomies. 4 This information supports the nominator's assertion that there have been notable changes in the surgical practice for these codes over time.

Lastly, the nominator highlighted incorrect usage of posterior osteotomy codes. They noted instances where facet/soft tissue releases, such as Schwab type I osteotomies, are inaccurately reported with these codes. According to the nominator, isolated partial facetectomy and soft tissue release are already included in spinal fusion procedures and should not be separately billed with an osteotomy code. Additionally, CMS in reviewing data for these services identified potential bundling of services within this code family. For instance, CPT code 22210 is frequently billed alongside CPT code 22600 ( Arthrodesis, posterior or posterolateral technique, single interspace; cervical below C2 segment ) (090-day global code), approximately 83 percent of the time. This indicates a common billing pattern, suggesting potential for coding revisions, including the consideration of consolidating individual services into bundled codes. Overall, based on the six reasons provided by the nominator, along with the fact that these codes were last valued almost 30 years ago, and given the identified billing practices, we concur that CPT codes 22210, 22212, 22214, and 22216 are potentially misvalued. The nominator suggested two options to address this concern: (1) developing add-on codes to differentiate between the number of vertebral segments involved in the osteotomy procedure and whether it occurs in the cervical, thoracic, or lumbar regions; and (2) removing the current posterior osteotomy codes and incorporating osteotomies into new deformity fusion codes, both with and without osteotomy. We are proposing to consider this code family as potentially misvalued and we appreciate the detailed information submitted by the nominator with sufficient supporting evidence. We believe that this code family would benefit from a comprehensive review by the RUC, and we welcome comments on a broader understanding of these codes. Additionally, we seek input on current standard billing practices. For example, information on whether the standard of Start Printed Page 61618 practice has evolved over time, and if so, how it has evolved, could aid in identifying potential coding issues related to this matter.

CPT code 27279 ( Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device ) (090 day global code) has been re-nominated as potentially misvalued based on the absence of separate direct PE inputs for this 090 day global code in the nonfacility setting. Currently, CPT code 27279 is only priced under the PFS in the facility setting, but the nominator is requesting that we establish separate direct PE inputs for this service to value the service when performed in the nonfacility/office setting (for example, in an office-based lab). The nominator stated that establishing payment for direct PE inputs in the nonfacility/office setting would increase access to this service for Medicare patients.

We did not nominate CPT code 27279 as potentially misvalued in the CY 2024 PFS final rule, mainly due to a lack of consensus on whether these services may be safely and effectively furnished in the nonfacility/office setting. In this year's submission, the nominator provided three post-market surveillance publications and two independent reviews of minimally invasive sacroiliac (SI) joint fusion procedures to support their assertion that this 90-day surgical service could be safely and effectively furnished in the nonfacility/office setting. Based on the studies, the nominator stated that the current medical literature provides evidence supporting the conclusion that percutaneous or minimally invasive SI joint arthrodesis (CPT code 27279) carries a complication rate that is acceptably low, comparable to other spinal procedures commonly performed in the office-based lab (OBL). For instance, the risk of major complications during lateral trans iliac (LTI) SI joint fusion (CPT code 27279) is lower than the risks associated with other OBL procedures. These include the risk of iliac perforation during angioplasty, the risk of death, myocardial infarction (MI), and stroke during diagnostic cardiac catheterization. The nominator did not reference literature regarding the rates of major complications for other OBL procedures in their submission.

Based on the information submitted we recognize the possibility that CPT code 27279 may be potentially misvalued, given the nominator's assertion that its complication rate is acceptably low based on the five studies they submitted. The results of the studies may suggest that CPT code 27279 can be safely performed in the office-based lab setting, as asserted by the nominator, with a relatively low complication rate. However, upon reviewing the submitted information, we also note that these studies collectively report heterogeneous safety outcomes. The large variabilities in safety outcomes reported in the studies, coupled with several unreported outcomes, may indicate that we have little knowledge about the effect of the service on safety outcomes, prompting the need for further investigation. Therefore, we are not proposing to consider this code as potentially misvalued, and we are instead seeking comments and additional studies from the broader medical community regarding whether this code should be priced under the PFS for the non-facility/office setting.

An interested party re-nominated CPT code 95800 ( Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time ) to update practice expenses that were last reviewed in 2017. This code was nominated as potentially misvalued in the CY 2024 PFS proposed rule ( 88 FR 52283 ). For the CY 2024 final rule, we stated that we were unable to properly assess whether CPT code 95800 is potentially misvalued based on the evidence submitted with the original nominations and subsequent comments that CMS received ( 88 FR 78849-78850 ). This year, an interested party re-nominated CPT code 59800 noting two significant changes: (1) in the technologies available to perform home sleep apnea testing (HSAT) services; and (2) in clinical practice that leads to the typical procedure reported with the CPT code 95800. According to the nominator, the current practice utilizes disposable HSAT technology, such as the WatchPat One device, more often than the reusable equipment currently included in the procedure's direct practice expense (PE) inputs.

To account for these changes, the nominator requested the deletion of three direct PE input codes: (1) equipment code EQ335 ( WatchPAT 200 Unit with strap, cables, charger, booklet, and patient video ); (2) equipment code EQ336 ( Oximetry and Airflow Device ); and (3) supply code SD263 ( WatchPAT pneumo-opt sleep probes), which are WatchPAT probes used with the reusable WatchPAT unit. Instead, the nominator requested the addition of a supply code SD362 (the WatchPAT ONE device ), a disposable HSAT technology, as a replacement. According to our PE supply list, the combined price of the items that the nominator requested to delete (EQ335, EQ336, and SD263) is $4.71 + $4.55 + $73.32 = $82.58, which is $15.62 less than the price of the item that the nominator requested to add (SD362), priced at $98.20. The price of $98.20 is mentioned in the nomination letter without an accompanying specific invoice. Last year, the nominator submitted invoices, showing a price of $99.00 each (a case of 12 totaling $1,188.00) for the WatchPat One Device (SD362) (see Table 6).

The nominator asserted that testing trends have shifted away from traditional airflow-based tests, with a noticeable rise in peripheral arterial tone (PAT)-based (non-airflow) tests. The traditional airflow-based tests use the reusable supplies and equipment, whereas the PAT-based non-airflow tests use the disposable HSAT device. While describing these changes in trends, the nominator did not provide us with their internal data, thus we are unable to verify its validity. The nominator also stated that disposable HSAT devices were used for nearly 50 percent of CPT code 95800 services in 2023 and attributed the increased use of disposable devices to the COVID-19 public health emergency (PHE). Furthermore, the nominator projected that over 50 percent of CPT code 95800 services will be furnished using disposable devices in 2024 and 2025. Explaining the patterns and predictions, the nominator concluded that the pandemic significantly altered the delivery of HSAT services, with many sleep physicians transitioning to single-use, disposable sleep tests as an alternative to the reusable testing equipment that is shipped from patient-to-patient after post-use cleaning. The nominator believes that, going forward, the typical procedure described by CPT code 95800 in CY 2024 and beyond will be furnished using disposable HSAT devices rather than reusable equipment.

Since the COVID-19 PHE ended in 2023, we are still unclear as to whether the typical procedure reported with CPT code 95800 involves the use of a reusable or disposable HSAT device. Given that we only have access to the nominator's summary of their internal data to observe changes in usage trends, which may not be generalizable, we propose to maintain the current direct PE supply and equipment inputs for CPT code 95800. While we are not currently proposing to review CPT code 95800 as potentially misvalued for CY 2025, we seek public comments on this nomination. In particular, we seek comments on whether the typical procedure described by CPT code 95800 now involves the use of a disposable HSAT device rather than reusable equipment.

An interested party nominated the CPT code 10021 ( Fine needle aspiration biopsy, without imaging guidance; first lesion ), CPT code 10004 ( Fine needle aspiration biopsy, without imaging guidance; each additional lesion ), CPT code 10005 ( Fine needle aspiration biopsy, including ultrasound guidance; first lesion ) and CPT code 10006 ( Fine needle aspiration biopsy, including ultrasound guidance; each additional lesion ) as potentially misvalued. We note that this code family has been nominated several times in recent years. We discussed our review of these codes and our rationale for finalizing the current values extensively in the CY 2019 PFS final rule ( 83 FR 59517 ), and CY 2021 PFS final rule ( 85 FR 84602 ). Furthermore, this code family was nominated as potentially misvalued and discussed in the CY 2020 PFS final rule ( 84 FR 62625 ). For more information we encourage the interested parties to go to our previous PFS final rules.

The nominator specifically requested that we revisit our work RVU decisions for these codes, stating that the underpinnings of the reduction in work RVUs from the RUC-recommended values were flawed. The nominator suggested that CMS should adopt the RUC-recommended work RVUs. For CPT code 10021, the RUC recommended a work RVU of 1.20, but we adopted a lower value of 1.03. Similarly, for CPT code 10005, the RUC recommended a work RVU of 1.63, but we adopted 1.46. The nominator disagreed with these reductions from the RUC-recommended values by CMS, raising particular concerns about our choice for the RVU crosswalk for CPT code 36440 ( Push blood transfusion, patient 2 years or younger ). According to the nominator, the CPT code we chose is not comparable to fine needle aspiration in any respect other than service time. The nominator raised several points, including that CPT code 36440 is rarely utilized and is almost never billed to Medicare because it pertains to a pediatric procedure conducted on neonates, while CPT code 10021 is never performed on neonates. They further asserted that the training and experience levels required to properly perform these procedures differ significantly; neonatal transfusions can be conducted by less experienced personnel, while performing a thyroid fine needle aspiration demands more experience. Specifically, they argued that there is a notable difference in the work intensity between the two procedures. The thyroid is closely positioned to vital structures such as the carotid artery, jugular vein, lymphatic vessels, nerves, trachea, and esophagus. When sampling thyroid nodules, they are often in proximity to the carotid artery, jugular vein, or both. According to the nominator, even a slight deviation of 1-2 millimeters during the sampling procedure can result in accidental puncture of these critical blood vessels or other nearby structures. Factors such as respiratory movements, patient swallowing, or anxiety may cause the thyroid to move, further increasing the Start Printed Page 61620 risk during the procedure. In contrast, neonatal phlebotomy does not require such measures. Also, the CPT code 36440 is designated as facility-only, meaning it does not include any clinical staff pre-service time and has no associated practice expense inputs. According to the nominator, fine needle aspiration is a very complex and high-risk procedure that may require significant physician work and a higher level of clinical expertise to furnish the service, which is very different from CPT code 36440. We appreciated the survey (N=74) results that the nominator submitted to support their statements. The nominator-conducted survey, and their survey questions aimed to gather information on the practitioners' experiences, opinions, and practices related to fine needle aspiration procedures. However, no other references such as peer reviewed medical literature or other nationally representative survey data were provided to reinforce their argument.

The nominator further stated that thyroid fine needle aspiration should exclusively be performed as an outpatient procedure and does not require hospitalization. The nominator emphasized that the reduction in payment for the code family due to the reduction in work RVUs from the RUC-recommended values has led endocrinologists in office-based practices, those who are not affiliated with facilities, to discontinue furnishing this service. According to the nominator, as a consequence of this payment decrease, patients are now being referred to hospital-based radiology practices, despite the fact that thyroid fine needle aspiration should ideally be conducted exclusively in nonfacility outpatient settings. The nominator asserted that radiologists in hospital settings are often unfamiliar with the patient's medical history and risk factors for suspected thyroid cancer. The nominator further noted that radiologists' training in thyroid cancer primarily emphasizes imaging and procedures, rather than considering the patient's overall health perspective. This result may further lead to an increase in medically unnecessary procedures. Additionally, the nominator believes that the payment reduction for this code family has the potential to diminish the specialist workforce trained to perform these procedures, thereby presenting future challenges in patient care and access to specialized services.

Overall, we appreciate the comprehensive information and level of detail provided by the nominator. The nominator disagreed with the choice of crosswalk CPT code 36440 made by CMS, emphasizing the differences in provider training, procedure risk, and patient population. They noted the rarity of Medicare billing for this code. Additionally, they emphasized the importance of outpatient thyroid fine needle aspiration being performed by endocrinologists. The shift to facility settings, prompted by reduced work RVUs, could raise Medicare costs. This, along with a potential decline in specialist workforce, may hinder patient access. However, in discussing this group of codes, we must note that these codes have been recently reviewed multiple times through the annual PFS rulemaking process. We would like to clarify once again that we disagree with the nominator that this code family is potentially misvalued. We acknowledge the possibility that there could be significant changes in the practice of delivering services described by these codes that were not fully reflected in the current work RVU. In such cases, it would be appropriate to refer the codes to the RUC to conduct a new survey to capture these changes accurately. However, we note that these codes underwent thorough RUC survey and review processes during the October 2017 and January 2018 RUC meetings. Based on these considerations, we disagree with the assertion that this code family is potentially misvalued. Nevertheless, we welcome comments on whether these codes should be re-reviewed in light of the arguments made by the nominator.

CMS routinely interacts with interested parties, and in our most recent review, we have observed several new devices that could be beneficial for populations but are not currently included in our coding system. While there are variations in the described devices, they commonly share the following descriptions. This device uses an innovative surgical technology that combines the separate functions of creating a myringotomy (incision in the eardrum), and positioning and placing a ventilation tube across the tympanic membrane. The new device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6 months and older. This device allows the tympanostomy service to be furnished to patients without general anesthesia and the service could therefore be performed in the office setting.

Regarding the delivery of this service using innovative surgical technology, CMS recognizes that CPT code 69433 ( Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia ) (010-day global code) may serve as a sufficient base code, adequately describing the majority of the surgeon's work and facility resources. However, a practitioner may incur additional resources, due to the higher expected intraservice work driven by both time and intensity factors, especially when furnishing a service to a child, and the cost of the device when using these devices as part of the performed procedure. While the existing CPT code 69433 is not age-specific, both the vignette and the RVU associated with this procedure are established for adult patients who can respond to surgeon direction, and do not have risk of movement during the procedure. We believe that potentially establishing additional coding and payment for tympanostomy services may enable the provision of these services utilizing new technologies to a broader patient population who may benefit from innovative surgical technology. To improve the accuracy of the payment for these services, we are soliciting comments on several alternatives that we are considering for adoption in the CY 2025 PFS final rule or future rulemaking. First, we are seeking comment on whether to establish a new G code that accounts for the work and practice expense for a procedure involving the positioning and placement of a ventilation tube across the tympanic membrane using an innovative surgical technology that combines the separate functions of creating a myringotomy (incision in the eardrum). We could assign contractor pricing to this potential G code for generalizable innovative tympanostomy tube delivery devices and/or systems falling under emerging technology and services categories. Alternatively, we are seeking comment on whether we should establish an add-on payment for the service using inputs from CPT code 69433 as a crosswalk reference, plus direct costs from invoices for the surgical devices referenced above. We are seeking comments regarding these potential approaches, particularly on whether there is additional information we should consider if we were to establish additional coding and payment for these services.

As discussed in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. See Start Printed Page 61621 further details and full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule ( 82 FR 53006 ), the CY 2021 PFS final rule ( 85 FR 84502 ) and the CY 2024 PFS final rule ( 88 FR 78861 through 78866 ) and in 42 CFR 410.78 and 414.65 . For a discussion of Telemedicine Evaluation and Management (E/M) Services, we refer readers to section II.E.4.18 of this proposed rule.

In the CY 2003 PFS final rule with comment period ( 67 FR 79988 ), we established a regulatory process for adding services to or deleting services from the Medicare Telehealth Services List in accordance with section 1834(m)(4)(F)(ii) of the Act. This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us and assigned to categories established through notice and comment rulemaking. Under the process we established beginning in CY 2003, we evaluated whether a service meets the following criteria:

Category 1: Services similar to professional consultations, office visits, and office psychiatry services currently on the Medicare Telehealth Services List. In reviewing these requests, we looked for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site, and, if necessary, the telepresenter, a practitioner who was present with the beneficiary in the originating site. We also looked for similarities in the telecommunications system used to deliver the service, for example, the use of interactive audio and video equipment.
Category 2: Services that are not similar to those on the current Medicare Telehealth Services List. Our review of these requests included assessing whether the service was accurately described by the corresponding code when furnished via telehealth and whether using a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient. Submitted evidence should have included both a description of relevant clinical studies that demonstrated the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer-reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit did not include minor or incidental benefits. Some examples of other clinical benefits that we considered include the following:
Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.
Treatment option for a patient population without access to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).
Decreased number of future hospitalizations or physician visits.
More rapid beneficial resolution of the disease process treatment.
Decreased pain, bleeding, or other quantifiable signs or symptoms.
Reduced recovery time.

In the CY 2021 PFS final rule ( 85 FR 84507 ), we created a third category of criteria for adding services to the Medicare Telehealth Services List on a temporary basis following the end of the PHE for the COVID-19 pandemic. This new category described services that were added to the Medicare Telehealth Services List during the PHE, for which there was likely to be clinical benefit when furnished via telehealth, but there was not yet sufficient evidence available to consider the services for permanent addition under the Category 1 or Category 2 criteria. Services added on a temporary, Category 3 basis ultimately needed to meet the criteria under Category 1 or 2 in order to be permanently added to the Medicare Telehealth Services List. To add specific services on a Category 3 basis, we would conduct a clinical assessment to identify those services for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth.

In the CY 2024 PFS final rule ( 88 FR 78861 through 78866 ), we consolidated these three categories and implemented a revised 5-step process for making additions, deletions, and changes to the Medicare Telehealth Services List (5-step process), beginning for the CY 2025 Medicare Telehealth Services List. Rather than categorizing a service as “Category 1” or “Category 2,” each service is now assigned a “permanent” or “provisional” status. As described further below, a service is assigned a “provisional” status if there is not enough evidence to demonstrate that the service is of clinical benefit, but there is enough evidence to suggest that further study may demonstrate such benefit. The 5-step process review criteria are set forth in the CY 2024 PFS final rule ( 88 FR 78861 through 78866 ), listed at https://www.cms.gov/medicare/coverage/telehealth/criteria-request , and summarized below. Consistent with the deadline for our receipt of code valuation recommendations from the American Medical Association's Relative Value Scale Update Committee (AMA RUC) and other interested parties ( 83 FR 59491 ) and with the process set forth in prior calendar years, for CY 2025, requests to add services to the Medicare Telehealth Services List must have been submitted to and received by CMS by February 10, 2024. Each request to add a service to the Medicare Telehealth Services List must have included any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process to make changes to the Medicare Telehealth Services List, requesters are advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request to add services to the Medicare Telehealth Services List, including where to send these requests, and to view the current Medicare Telehealth Service List, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html .

Step 1. Determine whether the service is separately payable under the PFS.

When considering whether to add, remove, or change the status of a service on the Medicare Telehealth Services List, we first determine whether the service, as described by the individual HCPCS code, is separately payable under the PFS because, as further discussed in CY 2024 PFS final rule ( 88 FR 78861 through 78866 ), Medicare telehealth services are limited to those services for which separate Medicare payments can be made under the PFS. Before gathering evidence and preparing to submit a request to add a service to the Medicare Telehealth Services List, the submitter should therefore first check the payment status for a given service and ensure that the service (as identified by a HCPCS code), is a covered and separately payable service under the PFS (as identified by payment status indicators A, C, T, or R on our public use files).

Step 2. Determine whether the service is subject to the provisions of section 1834(m) of the Act. Start Printed Page 61622

If we determine at Step 1 that a service is separately payable under the PFS, we apply Step 2 under which we determine whether the service at issue is subject to the provisions of section 1834(m) of the Act. Section 1834(m) of the Act provides for payment to a physician (or other practitioner) for a service furnished via an interactive telecommunications system, notwithstanding that the furnishing practitioner and patient are not in the same location, at the same amount that would have been paid if the service was furnished without the telecommunications system. We have historically interpreted this to mean that only services that are ordinarily furnished with the furnishing practitioner and patient in the same location can be classified as a “telehealth service” for which payment can be made under section 1834(m) of the Act. Given that there may be a range of services delivered using certain telecommunications technology that, though they are separately payable under the PFS, do not fall within the definition of telehealth service set forth in section 1834(m) of the Act, the aim of Step 2 is therefore to determine whether the service at issue is, in whole or in part, inherently a face-to-face service. Such services generally include services that do not require the presence of, or involve interaction with, the patient (for example, remote interpretation of diagnostic imaging tests, and certain care management services). Other examples include virtual check-ins, e-visits, and remote patient monitoring services which involve the use of telecommunications technology to facilitate interactions between the patient and practitioner, but do not serve as a substitute for an in-person encounter, for example, to assess whether an in-person or telehealth visit is needed or to transmit health information to the practitioner.

In determining whether a service is subject to the provisions of section 1834(m) of the Act, we therefore review during this Step 2 whether one or more of the elements of the service, as described by the particular HCPCS code at issue, ordinarily involve direct, face-to-face interaction between the patient and practitioner such that the use of an interactive telecommunications system to deliver the service would be a substitute for an in-person visit.

Step 3. Review the elements of the service as described by the HCPCS code and determine whether each of them is capable of being furnished using an interactive telecommunications system as defined in § 410.78(a)(3).

Step 3 is corollary to Step 2, and is used to determine whether one or more elements of a service are capable of being delivered via an interactive telecommunication system as defined in § 410.78(a)(3). In Step 3, we consider whether one or more face-to-face component(s) of the service, if furnished via audio-video communications technology, would be equivalent to the service being furnished in-person, and we seek information from requesters to demonstrate evidence of substantial clinical improvement in different beneficiary populations that may benefit from the requested service when furnished via telehealth, including, for example, in rural populations. The services are not equivalent when the clinical actions, or patient interaction, would not be of similar content as an in-person visit, or could not be completed.

Step 4. Consider whether the service elements of the requested service map to the service elements of a service on the list that has a permanent status described in previous final rulemaking.

The purpose of Step 4 is to simplify and reduce the administrative burden of submission and review. For Step 4, we review whether the service elements of a code that we are considering for addition to, or removal from, the Medicare Telehealth Services List map to the service elements of a service that is already on the list and is assigned permanent status. Any code that satisfies this criterion would require no further analysis. If the service elements of a code maps to the service elements of a code that is already included on the Medicare Telehealth Services List and is assigned permanent basis, we will add the code to the Medicare Telehealth Services List and assign it permanent status. While we have not previously found that the service elements of a code we are considering for addition to the list map to the elements of a service that was previously added to the list and assigned permanent basis, we believe that it is appropriate to apply this step 4 analysis to compare the candidate service with any permanent code that is on the list on a permanent basis. When Step 4 is met, further evidence review is not necessary. We continue to Step 5 if Step 4 is not met.

Step 5. Consider whether there is evidence of clinical benefit analogous to the clinical benefit of the in-person service when the patient, who is located at a telehealth originating site, receives a service furnished by a physician or practitioner located at a distant site using an interactive telecommunications system.

Similar to Steps 3, 4, and 5 above, the purpose of the proposed step 5 is to simplify and reduce the administrative burden. Under Step 5, we review the evidence provided with a submission to determine the clinical benefit of a service. We then compare the clinical benefit of that service, when provided via telehealth, to the clinical benefit of the service if it were to be furnished in person. If there is enough evidence to suggest that further study may demonstrate that the service, when provided via telehealth, is of clinical benefit, CMS will assign the code a “provisional” status on the Medicare Telehealth Services List. Where the clinical benefit of a service, when provided via telehealth, is clearly analogous to the clinical benefit of the service when provided in person, CMS will assign the code “permanent” status on the Medicare Telehealth Services List, even if the code's service elements do not map to the service elements of a service that already has permanent status. We reminded readers that our evidentiary standard of demonstrated clinical benefit does not include minor or incidental benefits ( 81 FR 80194 ). We review the evidence submitted by interested parties, and other evidence that CMS has on hand. The evidence should indicate that the service can be safely delivered using two-way interactive audio-video communications technology. Clinical practice guidelines, peer-reviewed literature, and similar materials, should illustrate specifically how the methods and findings within the material establish a foundation of support that each element of the defined, individual service described by the existing face-to-face service code has been studied in the typical setting of care, typical population of beneficiaries, and typical clinical scenarios that practitioners would encounter when furnishing the service using only interactive, two-way audio-video communications technology to complete the visit or encounter with Medicare beneficiaries. General evidence may also answer the question of whether a certain beneficiary population requiring care for a specific illness or injury may benefit from receiving a service via telehealth versus receiving no service at all, but must establish that the service is a substitute for an equivalent in-person service. Evidence should demonstrate how all elements described by the individual service code can be met when two-way, interactive audio-video communications technology is used as a complete substitute for any face-to-face interaction required between the patient and practitioner that are described in the individual code descriptor. We further remind readers that submissions Start Printed Page 61623 reflecting practitioner services furnished to Medicare beneficiaries are helpful in our considerations.

We received several requests to permanently add various services to the Medicare Telehealth Services List, effective for CY 2025. The requested services are listed in Table 7.

Many services were added to the Medicare Telehealth Services List on a temporary basis as discussed in the March 31st COVID-19 interim final rule with comment period (IFC) ( 85 FR 19235 through 19237 ) for the PHE for Covid-19, and we subsequently retained these services on a provisional basis. All of the received submissions were requests for addition on a permanent basis. We believe that, rather than selectively adjudicating only those services for which we received requests for potential permanent status, it would be appropriate to complete a comprehensive analysis of all provisional codes currently on the Medicare Telehealth Services List before determining which codes should be made permanent. We are therefore not making determinations to recategorize provisional codes as permanent until such time as CMS can complete a comprehensive analysis of all such provisional codes which we expect to address in future rulemaking.

The following is a discussion of the requests received for addition of services to the Medicare Telehealth Services List:

We received a request to add CPT code 95251 ( Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; analysis, interpretation and report ) to the Medicare Telehealth Services List and assign it permanent status. This code is not on the Medicare Telehealth Services List, nor had it been previously added and removed. The requester stated that the ability of the practitioner to interpret continuous glucose monitoring data and communicate changes in the diabetes care plan to our patients is enhanced by the availability of video visits, and the code should therefore be added to the Medicare Telehealth Services List. This service does not meet the criteria described by Step 2 of the 5-step process: determination of whether the service is subject to the provisions of section 1834(m) of the Act. Section 1834(m) of the Act limits the definition of Medicare telehealth services to those services that would ordinarily be furnished with the furnishing practitioner and patient in the same location (88 78863). In other words, as stated above, for a service to be considered a Medicare telehealth service subject to and payable under section 1834(m) of the Act, the service must be so analogous to in-person care such that the telehealth service, as defined in § 410.78, is essentially a substitute for a face-to-face encounter. We do not consider this service a Medicare telehealth service because it is not an inherently face-to-face service; the patient does not need to be present for the service to be furnished in its entirety. CPT code 95251 describes sensor placement and monitoring over a 72-hour period. We do not consider CPT code 95251 a telehealth service under section 1834(m) of the Act or our regulation at § 410.78. Therefore, we are not proposing to add this service to the Medicare Telehealth Services List.

We received requests to permanently add cardiovascular rehabilitation services (CPT codes 93797 and 93798) and pulmonary rehabilitation services (CPT codes 94625 and 94626) to the Medicare Telehealth Services List. These services are currently on the Medicare Telehealth List and are assigned provisional status. We had originally added CPT codes 93797 and 93798 and HCPCS codes G0422 and G0423 on a temporary basis in the CY 2022 PFS final rule (FR 86 65054 through 65055). A requester cited studies that they say demonstrate that the availability of these services via telehealth enhances access and patient equity. Another requester cited evidence of improved outcomes for patients that had access to these services via telehealth. As explained previously, we are not proposing to revise the status of codes from provisional to permanent in this proposed rule because we intend to conduct a comprehensive review. While considering these issues for future rulemaking, we are not proposing to assign CPT codes 93797 and 93798 or CPT codes 94625 and 94626 permanent status on the Medicare Telehealth Services List and would instead maintain the services on the Medicare Telehealth Services List on a provisional basis for CY 2025.

We received a request to add Health and Well-Being Coaching (CPT codes 0591T-0593T) to the Medicare Telehealth Services List with permanent status. These services are currently on the Medicare Telehealth Services List and are assigned a provisional status. We originally added these codes on a provisional basis in the CY 2024 PFS final rule (FR 88 78859 and 78860). One requester stated that health and well-being coaching, including content education, delivered in a telehealth modality is an evidence-based, cost- Start Printed Page 61626 effective, sustainable, and common sense approach to facilitating lifestyle/behavioral intervention and treating the Medicare population with or at heightened risk for chronic diseases. As explained previously, we are not proposing to revise the status of codes from provisional to permanent in this proposed rule because we intend to conduct a comprehensive review. Therefore, we are not proposing to assign them to the Medicare Telehealth Services List with permanent status.

We received a request to add Psychological Testing and Developmental Testing (CPT codes 96112, 96113, 96130, 96136, and 96137) to the Medicare Telehealth Services List on a permanent basis. These services are currently on the Medicare Telehealth Services List and are assigned provisional status. In the March 31, 2020 interim final rule with comment period (IFC-1) ( 85 FR 19239 ), we originally added CPT codes 96130, 96136, and 96137 to the Medicare Telehealth Services List for the duration of the PHE for COVID-19, and in the CY 2021 PFS final rule ( 85 FR 85003 ), we stated we were retaining them on the list on a category 3 basis. In the CY 2023 PFS final rule ( 87 FR 69460 ), we added CPT codes 96112 and 96113 on a temporary basis.

As explained previously, we are not proposing to revise the status of codes from provisional to permanent in this proposed rule because we intend to conduct a comprehensive review. Therefore, we are not proposing to either remove these services from or to assign them permanent status on the Medicare Telehealth Services List.

We received multiple requests to add the Therapy services described by CPT codes 97110, 97112, 97116, 97161 through 97164, 97530 and 97535, 97165 through 97168, and Audiology and Speech Language Pathology services CPT codes 92507, 92508, 92521 through 92524, 92526, 92607 through 92610, 96105 92626, 92627, 96125, 97129, 97130, 92607 through 92609 92550 through 92557, 92563, 92565 92567, 92568, 92570, 92587, 92588, 92601 through 92604, 92625 through 92627, and 92651 and 92652 to the Medicare Telehealth Services List on a permanent basis stating that continuing Telehealth flexibilities for these services could lead to reduced health care expenditures, increased patient access, and improved management of chronic disease and quality of life. These services are currently available on the Medicare Telehealth Services List and are assigned provisional status, and we refer readers to section II.D.1. for further discussion of these services. In the CY 2023 PFS final rule ( 87 FR 69451 ), we originally added CPT codes 90901, 97150, 97530, 97537, 97542, 97763, and 98960-98962 to the Medicare Telehealth Services List on a Category 3 basis. As explained previously, we are not proposing to revise the status of codes from provisional to permanent in this proposed rule because we intend to conduct a comprehensive review. Therefore, we are not proposing to assign them permanent status on the Medicare Telehealth Services List.

We received a request to permanently add General Behavioral Health Integration (CPT code 99484) and Principal Care Management (CPT codes 99424-99427) to the Medicare Telehealth Services List. These services are not on the Medicare Telehealth Services List, nor have they been previously added and removed. These services do not meet the criteria described by Step 2 of the 5-step process: determination of whether the service is subject to the provisions of section 1834(m) of the Act. As stated above, the scope of section 1834(m) of the Act is limited to services that would ordinarily be furnished with the furnishing practitioner and patient in the same location (88 78863), and for a service to be considered a telehealth service subject to and payable under section 1834(m) of the Act, the service must be so analogous to in-person care such that the telehealth service, as defined in § 410.78, is essentially a substitute for a face-to-face encounter. We do not consider these services to be Medicare telehealth services because they are not inherently face-to-face services, and the patient need not be present for the services to be furnished in its entirety. Therefore, we do not consider CPT codes 99484 and 99424-99427 to be telehealth services under section 1834(m) of the Act or our regulation at § 410.78. Therefore, we are not proposing to add this service to the Medicare Telehealth Services List.

We received a request to permanently add Posterior tibial neurostimulation (CPT code 64566) to the Medicare Telehealth Services List. This code is not on the Medicare Telehealth Services List, nor had it been previously added and removed. This service does not meet the criteria for addition described by Step 3 of the 5-step process, namely the review the elements of the service as described by the HCPCS code and determine whether each of them is capable of being furnished using an interactive telecommunications system as defined in § 410.78(a)(3). The requestor describes the services underlying CPT code 64566 as the continual or recurring treatments over a period of time consisting of the remote monitoring of device utilization and bladder diary for the generation of reports for review by the care provider. Based on our review, this description does not align with the elements of the service as described by CPT code 64566. CPT code 64566 describes a single treatment provided by a clinician who has direct contact with the patient and inserts an electrode into the skin overlying the posterior tibial nerve. Upon conclusion of the treatment, the clinician removes the electrode and examines and dresses the puncture wound. Providing these services would require in-person interaction. We are therefore not proposing to add the service to the Medicare Telehealth Services List because we do not believe the service elements can be met in full using two-way audio-video telecommunications technology.

We received requests to permanently add Radiation Treatment Management (CPT code 77427) to the Medicare Telehealth Services List. The code is currently on the Medicare Telehealth List with provisional status. In the March 31, 2020 IFC ( 85 FR 9240 ), we originally added CPT code 77427 on the Medicare Telehealth Services List for the duration of the PHE for Covid-19. A requester stated that data collected during the PHE demonstrates that the telehealth option is as safe as the in-person equivalent. We also received a request that we remove this code from the Medicare Telehealth Services List, citing the importance of in-person physical examination to ensure quality of care and stating that a telehealth modality presents patient safety concerns such as those related to the ability of the practitioner to address side effects of radiation therapy. Given the safety concerns raised by members of the practitioner community, we believe this service may not be safely and effectively furnished, and therefore believe that such concerns merit removing this item from the telehealth list. We are therefore proposing to remove this code from the Medicare Telehealth Services List, and we are Start Printed Page 61627 soliciting comment on these quality of care concerns.

We received a request to permanently add Home INR Monitoring (HCPCS code G0248) to the Medicare Telehealth Services List. This service is not on the Medicare Telehealth Services List, nor had it been previously added and removed. We are proposing to add HCPS code G0248 to the Medicare Telehealth Services List with provision status because our clinical analyses of these services indicate that they can be furnished in full using two-way, audio and video technology, and information provided by requesters indicates that there may be clinical benefit; however, there is not yet sufficient evidence available to consider the services for permanent status. This service as described by the HCPCS code describes face-to-face demonstration of use and care of the INR monitor, obtaining at least one blood sample, provision of instructions for reporting home INR test results, and documentation of patient's ability to perform testing and report results, and we believe each of these service elements the elements is capable of being furnished using an interactive telecommunications system. Adding this service on a provisional basis will allow additional time for the development of evidence of clinical benefit when this service is furnished via telehealth for CMS to consider when evaluating this service for potential permanent addition to the Medicare Telehealth Services List.

We received a request to permanently add Caregiver Training services, as described by HCPCS codes 97550 ( Caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety practices) (without the patient present), face to face; initial 30 minutes ) and CPT code 97551 (Caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (eg, activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety practices) (without the patient present), face to face; each additional 15 minutes (List separately in addition to code for primary service)) to the Medicare Telehealth Services List. These codes do not currently appear on the Medicare Telehealth Services List nor had they previously been added or removed. We are proposing to add these services to the Medicare Telehealth List with provisional status for CY 2025, in addition to the other currently payable caregiver training service codes (CPT codes 97550, 97551, 97552, 96202, 96203). These codes are new services that were added to the PFS beginning in 2024. Given the limited utilization of those codes added for 2024, there are not peer-reviewed studies supporting these codes' ability to be furnished remotely. Adding these services on a provisional basis will allow additional time for the development of evidence of clinical benefit when these services are furnished via telehealth for CMS to consider when evaluating these services for potential permanent addition to the Medicare Telehealth Services List. Contingent upon finalizing the service code descriptions that we propose in section II.E. of this proposed rule, we also propose that HCPCS code GCTD1-3 and GCTB1-2 be added to the Medicare Telehealth Services list for CY 2025 on a provisional basis. We believe that these codes are similar to other services already available on the Medicare Telehealth Services List, including education and training for patient self-management (CPT codes 98960-98962), self-care/home management training (CPT codes 97535), and caregiver-focused health risk assessment (CPT code 96161). Further, it appears that all elements of these services may be furnished when using two-way interactive communications technology. Adding these services on a provisional basis will allow additional time for the development of evidence of clinical benefit when this service is furnished via telehealth for CMS to consider when evaluating these services for potential permanent addition to the Medicare Telehealth Services List.

As discussed in Section II.E. of this proposed rule, we are proposing national rates for HCPCS codes G0011 (Individual counseling for pre-exposure prophylaxis (PrEP) by physician or QHP to prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence, 15-30 minutes) and G0013 (Individual counseling for pre-exposure prophylaxis (PrEP) by clinical staff to prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence) pending the future finalization of the NCD for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection. We believe these services are similar to services currently on the Medicare Telehealth Services list, specifically HCPCS codes G0445 (High intensity behavioral counseling to prevent sexually transmitted infection; face-to-face, individual, includes: education, skills training and guidance on how to change sexual behavior; performed semi-annually, 30 minutes) and CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional) as these codes are the codes from which HCPCS codes G0011 and G0013 were unbundled, respectively. As similarity to services currently on the Medicare telehealth list is one of our criteria for permanent addition, we are proposing to add HCPCS codes G0011 and G0013 to the Medicare Telehealth Services List with a permanent status.

The services that we are proposing to add to the Medicare Telehealth Services List are listed in Table 8.

When adding some services to the Medicare Telehealth Services List in the past, we have included certain frequency restrictions on how often practitioners may furnish the service via Medicare telehealth. These include a limitation of one subsequent hospital care service furnished through telehealth every 3 days, added in the CY 2011 PFS final rule ( 75 FR 73317 through 73318 ), one subsequent nursing facility visit furnished through telehealth every 14 days, added in the CY 2011 PFS final rule ( 75 FR73318 ), and one critical care consultation service furnished through telehealth per day, added in the CY 2017 final rule ( 81 FR 80198 ). In establishing these limits, we cited concerns regarding the potential acuity and complexity of these patients.

We temporarily removed these frequency restrictions during the PHE for COVID-19. In the March 31, 2020 COVID-19 interim final rule with comment period (IFC) ( 85 FR 19241 ), we stated that we did not believe the frequency limitations for certain subsequent inpatient visits, subsequent NF visits, and critical care consultations furnished via Medicare telehealth were appropriate or necessary for the duration of the PHE because this would have been a patient population who would have otherwise not had access to clinically appropriate in-person treatment. Although the frequency limitations resumed effect on May 12, 2023 (upon expiration of the PHE), through enforcement discretion during the remainder of CY 2023 and notice-and-comment rulemaking for CY 2024, Medicare telehealth frequency limitations have been suspended for CY 2024 ( 88 FR 78876 through 78878 ) for the following codes relating to Subsequent Inpatient Visits, Subsequent Nursing Facility Visits, and Critical Care Consultation Services:

99231 ( Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward or low level of medical decision making. when using total time on the date of the encounter for code selection, 25 minutes must be met or exceeded. );
99232 ( Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. when using total time on the date of the encounter for code selection, 35 minutes must be met or exceeded. ); and
99233 ( Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. when using total time on the date of the encounter for code selection, 50 minutes must be met or exceeded. )
99307 ( Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. when using total time on the date of the encounter for code selection, 10 minutes must be met or exceeded. );
99308 ( Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and low level of medical decision making. when using total time on the date of the encounter for code selection, 15 minutes must be met or exceeded. );
99309 ( Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. when using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded. ); and
99310 ( Subsequent nursing facility care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. when using total time on the date of the encounter for code selection, 45 minutes must be met or exceeded. )
G0508 ( Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth. ); and
G0509 ( Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth. )

We are proposing to remove the frequency limitations for these codes for CY 2025.

In the CY 2024 PFS final rule ( 88 FR 78877 ), we solicited comments from interested parties on how practitioners have been ensuring that Medicare beneficiaries receive subsequent inpatient and nursing facility visits, as well as critical care consultation services since the expiration of the PHE. As discussed in that final rule, many commenters supported permanently removing these frequency limitations, stating that they are arbitrary and re-imposing the limitations would result in decreased access to care; that practitioners should be allowed to use Start Printed Page 61632 their clinical judgment to determine the type of visit, how many visits, and the type of treatment that is the best fit for the patient so long as the standard of care is met; and that lifting these limitations during the PHE has been instructive and demonstrates the value of continuing such flexibilities. Many commenters urged us to permanently remove them. That said, some commenters did not support removing these frequency limitations citing patient acuity and safety, some commenters cited the importance of in-person care for patients in acute care settings. Some commenters stated that telehealth patient assessments and evaluations are never the same as in-person, hands on visits and should not be considered a viable replacement with no limitations for in-person care. We are continuing to consider what changes we should be making to how telehealth services are reimbursed under Medicare in light of the way practice patterns may have changed following the PHE for COVID-19. Taking into account the information received from commenters in the CY 2024 PFS final rule, we believe it is reasonable to continue to pause certain pre-pandemic restrictions, such as the frequency limitations for the abovementioned codes for CY 2025. Removing such restrictions for CY 2025 will allow us to gather an additional year of data to determine how practice patterns are evolving and what changes, if any, to frequency limitations should be made. We do not believe pausing such frequency limitations for another year presents a level of safety risk requiring us to immediately reinstate the limitations. Our analysis of claims data indicates that the volume of services that would be affected by implementing these limitations is relatively low; in other words, these services are not being furnished via telehealth with such frequency that frequency limits are being met or exceeded very often or for many beneficiaries (claims data from 2020—2023 suggest that less than five percent received one or more of these services as a telehealth service). Therefore, while claims data does not suggest that lifting these limitations during the PHE has led to an increase in utilization, we continue to be interested in information from interested parties on our concerns regarding the potential acuity and complexity of these patients and how such acuity and complexity should complexity should influence our implementation of frequency limitations.

Through our regulation at § 410.78(a)(3), we define “interactive telecommunications system” as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. Through emergency regulations and waiver authority under section 1135(b)(8) of the Act, in response to the PHE for COVID-19, we allowed the use of audio-only communications technology to furnish services described by the codes for audio-only telephone evaluation and management services and behavioral health counseling and educational services. Section 4113 of the CAA, 2023, extended the availability of telehealth services that can be furnished using audio-only technology and provided for the extension of other PHE-related flexibilities including removal of the geographic and location limitations under section 1834(m) of the Act through December 31, 2024.

In the CY 2022 PFS final rule ( 86 FR 65060 ), in part to recognize the changes made by section 123 of the CAA, 2021 that removed the geographic restrictions for Medicare telehealth services for the diagnosis, evaluation, or treatment of a mental health disorder and the addition of the patient's home as a permissible originating site for these services, we revisited our regulatory definition of “interactive telecommunications system” beyond the circumstances of the PHE. Specifically, we finalized a policy to allow for audio-only services under certain circumstances and revised the regulation at § 410.78(a)(3) to permit the use of audio-only equipment for telehealth services furnished to established patients in their homes for purposes of diagnosis, evaluation, or treatment of a mental health disorder (including substance use disorders) if the distant site physician or practitioner is technically capable of using an interactive telecommunications system as defined previously, but the patient is not capable of, or does not consent to, the use of video technology. We also established this policy in part because mental health services are different from most other services on the Medicare telehealth services list in that many of the services primarily involve verbal conversation where visualization between the patient and furnishing physician or practitioner may be less critical to the provision of the service.

However, with the successive statutory extensions of the telehealth flexibilities implemented in response to the PHE for COVID-19, most recently by the CAA, 2023, and our adoption of other extensions where we have had authority to do so, we have come to believe that it would be appropriate to allow interactive audio-only telecommunications technology when any telehealth service is furnished to a beneficiary in their home (when the patient's home is a permissible originating site) and when the distant site physician or practitioner is technically capable of using an interactive telecommunications system as defined previously, but the patient is not capable of, or does not consent to, the use of video technology. While practitioners should always use their clinical judgment as to whether the use of interactive audio-only technology is sufficient to furnish a Medicare telehealth service, we recognize that there is variable broadband access in patients' homes, and that even when technologically feasible, patients simply may not always wish to engage with their practitioner in their home using interactive audio and video. Under current statute, with the expiration of the PHE-related telehealth flexibilities on December 31, 2024, the patient's home is a permissible originating site only for services for the diagnosis, evaluation, or treatment of a mental health or substance use disorder, and for the monthly ESRD-related clinical assessments described in section 1881(b)(3)(B) of the Act.

We are proposing to revise the regulation at § 410.78(a)(3) to state that an interactive telecommunications system may also include two-way, real-time audio-only communication technology for any telehealth service furnished to a beneficiary in their home if the distant site physician or practitioner is technically capable of using an interactive telecommunications system as defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication, but the patient is not capable of, or does not consent to, the use of video technology. Additionally, a modifier designated by CMS must be appended to the claim for services described in this paragraph to verify that these conditions have been met. These are CPT modifier “93” and, for RHCs and FQHCs, Medicare modifier “FQ” (Medicare telehealth service was furnished using audio-only communication technology). Start Printed Page 61633 Practitioners have the option to use the “FQ” or the “93” modifiers or both where appropriate and true, since they are identical in meaning.

In the CY 2024 PFS final rule ( 88 FR 78873 through 78874 ) we discussed that many commenters expressed concerns regarding the expiring flexibility for telehealth practitioners to bill from their currently enrolled location instead of their home address when providing telehealth services from their home. CMS issued an FAQ, available at https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf , which extended the flexibility for telehealth practitioners to bill from their currently enrolled location instead of their home address when providing telehealth services from their home through December 31, 2023. Interested parties suggested that the expiration of this flexibility poses a potential and imminent threat to the safety and privacy of health professionals who work from home and furnish telehealth services. Commenters cited recent examples of workplace violence in health care facilities, where direct harm to nurses and other medical staff occurred. In addition to safety and privacy concerns, interested parties explained that a significant number of practitioners would need to change their billing practices or add their home address to the Medicare enrollment file, coordinating with the appropriate Medicare Administrative Contractor in their jurisdiction, and this would present administrative burden. To address these concerns, commenters requested that CMS take steps to protect telehealth practitioners by adjusting enrollment requirements so that individual practitioners do not have to list their home addresses on enrollment forms.

In response, CMS finalized, through CY 2024, that we would continue to permit a distant site practitioner to use their currently enrolled practice location instead of their home address when providing telehealth services from their home.

We have continued to hear from interested parties who have stressed the importance of continuing this flexibility for the safety and privacy of health care professionals. Given the shift in practice patterns toward models of care that include the practitioner's home as the distant site, we believe it would be appropriate to continue this flexibility as CMS considers various proposals that may better protect the safety and privacy of practitioners. We are therefore proposing that through CY 2025 we will continue to permit the distant site practitioner to use their currently enrolled practice location instead of their home address when providing telehealth services from their home.

Under Medicare Part B, certain types of services, including diagnostic tests described under § 410.32 and services incident to a physician's (or other practitioner's) professional service described under § 410.26 (incident-to services), are required to be furnished under specific minimum levels of supervision by a physician or other practitioner. We define three levels of supervision in our regulation at § 410.32(b)(3): General Supervision, Direct Supervision, and Personal Supervision. Notwithstanding the temporary measures implemented in response to the PHE for COVID-19, direct supervision requires the physician (or other supervising practitioner) to be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the service. It does not mean that the physician (or other supervising practitioner) must be present in the room when the service is performed. Again, notwithstanding the temporary measures implemented in response to the PHE for COVID-19, we have established this “immediate availability” requirement to mean in-person, physical, not virtual, availability (please see the April 6, 2020 IFC ( 85 FR 19245 ) and the CY 2022 PFS final rule ( 86 FR 65062 )).

Direct supervision is required for various types of services, including most incident-to services under § 410.26, many diagnostic tests under § 410.32, pulmonary rehabilitation services under § 410.47, cardiac rehabilitation and intensive cardiac rehabilitation services under § 410.49, and certain hospital outpatient services as provided under § 410.27(a)(1)(iv). In the March 31, 2020 COVID-19 IFC, we amended the definition of “direct supervision” for the duration of the PHE for COVID-19 ( 85 FR 19245 through 19246 ) at § 410.32(b)(3)(ii) to state that the necessary presence of the physician (or other practitioner) for direct supervision includes virtual presence through audio/video real-time communications technology. Instead of requiring the supervising physician's (or other practitioner's) physical presence, the amendment permitted a supervising physician (or other practitioner) to be considered “immediately available” through virtual presence using two-way, real-time audio/visual technology for diagnostic tests, incident-to services, pulmonary rehabilitation services, and cardiac and intensive cardiac rehabilitation services. We made similar amendments at § 410.27(a)(1)(iv) to specify that direct supervision for certain hospital outpatient services may include virtual presence through audio/video real-time communications. The CY 2021 PFS final rule ( 85 FR 84538 through 84540 ) and the CY 2024 PFS final rule ( 88 FR 78878 ) subsequently extended these policies through December 31, 2024. As stated in the CY 2024 PFS final rule, we extended this definition of direct supervision through December 31, 2024, in order to align the timeframe of the policy with other PHE-related telehealth policies that were extended most recently under the provisions of the CAA, 2023.

We note that in the CY 2021 PFS final rule ( 85 FR 84539 ) we clarified that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology, the requirement could be met by the supervising physician (or other practitioner) being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the service. We noted that this was the case during the PHE and would continue to be the case following the PHE. While flexibility to provide direct supervision through audio/video real-time communications technology was adopted to be responsive to critical needs during the PHE for COVID-19 to ensure beneficiary access to care, reduce exposure risk and to increase the capacity of practitioners and physicians to respond to COVID-19, we expressed concern that direct supervision through virtual presence may not be sufficient to support PFS payment on a permanent basis, beyond the PHE for COVID-19, due to issues of patient safety. For instance, in complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change; in-person supervision would be necessary for such services to allow for rapid on-site decision-making in the event of an Start Printed Page 61634 adverse clinical situation. In addition to soliciting comment in the CY 2021 PFS proposed rule on whether there should be any additional “guardrails” or limitations to ensure patient safety/clinical appropriateness, beyond typical clinical standards, as well as restrictions to prevent fraud or inappropriate use, we solicited comment in the CY 2024 PFS proposed rule on whether we should consider extending the definition of direct supervision to permit virtual presence beyond December 31, 2024. Specifically, we stated that we were interested in input from interested parties on potential patient safety or quality concerns when direct supervision occurs virtually; for instance, if direct supervision of certain types of services with virtual presence of the supervising practitioner is more or less likely to present patient safety concerns, or if this flexibility would be more appropriate for certain types of services, or when certain types of auxiliary personnel are performing the supervised service. We were also interested in potential program integrity concerns that interested parties may have regarding this policy, such as overutilization or fraud and abuse.

As discussed in the CY 2024 PFS final rule ( 88 FR 78878 ), in the absence of evidence that patient safety is compromised by virtual direct supervision, we are concerned about an abrupt transition to our pre-PHE policy that defines direct supervision to require the physical presence of the supervising practitioner. We noted that an immediate reversion to the pre-PHE definition of direct supervision would prohibit virtual direct supervision, which may present a barrier to access to many services, such as incident-to services, and that physicians and/or other supervising practitioners, in certain instances, would need time to reorganize their practice patterns established during the PHE to reimplement the pre-PHE approach to direct supervision without the use of audio/video technology. We acknowledge the utilization of this flexibility and recognize that many practitioners have stressed the importance of maintaining it, however we seek additional information regarding potential patient safety and quality of care concerns. This flexibility has been available and widely utilized since the beginning of the PHE, and we recognize that may enhance patient access. However, given the importance of certain services being furnished under direct supervision in ensuring quality of care and patient safety, and in particular the ability of the supervising practitioner to intervene if complications arise, we believe an incremental approach is warranted, particularly in instances where unexpected or adverse events may arise for procedures which may be riskier or more intense. In light of these potential safety and quality of care implications, and exercising an abundance of caution, we are extending this flexibility for all services on a temporary basis only. We are therefore proposing to continue to define direct supervision to permit the presence and “immediate availability” of the supervising practitioner through real-time audio and visual interactive telecommunications through December 31, 2025.

In the CY 2024 PFS proposed rule, we solicited comment on extending or permanently establishing the virtual presence flexibility for certain services valued under the PFS given that these services typically are performed in their entirety by auxiliary personnel as defined at § 410.26(a)(1). We stated such services would include incident-to services wholly furnished by auxiliary personnel, Level I office or other outpatient E/M visits for established patients. We also mentioned Level I Emergency Department (ED) visits in this list, but have since concluded that ED services would not be wholly furnished by auxiliary personnel and, for that reason, have excluded them from the discussion in this proposed rule. Based on our review, these specific services present less of a patient safety concern than services for which there may be a need for immediate intervention of the supervising practitioner; as noted in the CY 2024 PFS proposed rule, allowing virtual presence for direct supervision of these services could balance patient safety concerns with the interest of supporting access and preserving workforce capacity for medical professionals while considering potential quality and program integrity concerns. After reviewing the various comments in response to this solicitation, additional feedback provided by interested parties, and conducting our own independent review, we believe these services are low risk by their nature, do not often demand in-person supervision, are typically furnished entirely by the supervised personnel, and allowing virtual presence for direct supervision of these services would balance patient safety concerns with the interest of supporting access and preserving workforce capacity.

We are proposing to adopt a definition of direct supervision that allows “immediate availability” of the supervising practitioner using audio/video real-time communications technology (excluding audio-only), but only for the following subset of incident-to services described under § 410.26: (1) services furnished incident to a physician or other practitioner's service when provided by auxiliary personnel employed by the billing practitioner and working under their direct supervision, and for which the underlying HCPCS code has been assigned a PC/TC indicator of `5'; [ 10 ] and (2) services described by CPT code 99211 ( Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional ). As provided in the code descriptor for CPT code 99211, an office or other outpatient visit for the evaluation and management of an established patient may not require the presence of a physician or other practitioner and may be furnished incident to a physicians' service by a nonphysician employee of the physician under direct supervision. The service described by CPT code 99211 and the services that are identified with a PC/TC indicator of `5' as listed in the PFS Relative Value Files are services that are nearly always performed in entirety by auxiliary personnel. The vignette for CPT code 99211 describes the provision of supervision and guidance to the clinical staff as necessary. The code descriptor for this service specifies an E/M service that may not require the presence of a physician or other professional; and the current valuation, which is relatively low compared to other office and outpatient E/M services, suggests that this service would primarily be provided by auxiliary personnel.

We are proposing an incremental approach whereby we will adopt without any time limitation the definition of direct supervision Start Printed Page 61635 permitting virtual presence for services that are inherently lower risk: that is, services that do not ordinarily require the presence of the billing practitioner, do not require direction by the supervising practitioner to the same degree as other services furnished under direct supervision, and are not services typically performed directly by the supervising practitioner.

For all other services required to be furnished under the direct supervision of the supervising physician or other practitioner, we are proposing, as described above, to continue to define “immediate availability” to include real-time audio and visual interactive telecommunications technology only through December 31, 2025.

We are proposing to revise the regulations at § 410.32(b)(3)(ii) to state that through December 31, 2025, the presence of the physician (or other practitioner) would include virtual presence through audio/video real-time communications technology (excluding audio-only).

We are proposing to revise the regulation at § 410.26(a)(2) to state that for the following services furnished after December 31, 2025, the presence of the physician (or other practitioner) required for direct supervision shall continue to include virtual presence through audio/video real-time communications technology (excluding audio-only): services furnished incident to a physician's service when they are provided by auxiliary personnel employed by the physician and working under his or her direct supervision and for which the underlying HCPCS code has been assigned a PC/TC indicator of `5'; and office and other outpatient visits for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional.

In the CY 2021 PFS final rule ( 85 FR 84577 through 84584 ), we established a policy that, after the end of the PHE for COVID-19, teaching physicians may meet the requirements to be present for the key or critical portions of services when furnished involving residents through audio/video real-time communications technology (virtual presence), but only for services furnished in residency training sites located outside of an Office of Management and Budget (OMB)-defined metropolitan statistical area (MSA). We made this location distinction consistent with our longstanding interest in increasing beneficiary access to Medicare-covered services in rural areas. We noted the ability to expand training opportunities for residents in rural settings. For all other locations, we expressed concerns that continuing to permit teaching physicians to bill for services furnished involving residents when they are virtually present, outside the conditions of the PHE for COVID-19, may not allow the teaching physician to have personal oversight and involvement over the management of the portion of the case for which the payment is sought, under section 1842(b)(7)(A)(i)(I) of the Act. In addition, we stated concerns about patient populations that may require a teaching physician's experience and skill to recognize specialized needs or testing and whether it is possible for the teaching physician to meet these clinical needs while having a virtual presence for the key portion of the service. We refer readers to the CY 2021 PFS final rule ( 85 FR 84577 through 84584 ) for a more detailed description of our specific concerns. At the end of the PHE for COVID-19, and as finalized in the CY 2021 PFS final rule, we intended for the teaching physician to have a physical presence during the key portion of the service personally provided by residents in order to be paid for the service under the PFS, in locations that were within a MSA. This policy applied to all services, regardless of whether the patient was co-located with the resident or only present virtually (for example, the service was furnished as a 3-way telehealth visit, with the teaching physician, resident, and patient in different locations). However, interested parties expressed concerns regarding the requirement that the teaching physician be physically present with the resident when a service is furnished virtually (as a Medicare telehealth service) within an MSA. Some interested parties stated that during the PHE for COVID-19, when residents provided telehealth services, and the teaching physician was virtually present, the same safe and high-quality oversight was provided as when the teaching physician and resident were physically co-located. In addition, these interested parties stated that during telehealth visits, the teaching physician was virtually present during the key and critical portions of the telehealth service, available immediately in real-time, and had access to the electronic health record. After review of the public comments, we finalized a policy that allowed the teaching physician to have a virtual presence in all teaching settings, only in clinical instances when the service was furnished virtually (for example, a 3-way telehealth visit, with all parties in separate locations). This permitted teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment was sought, through audio/video real-time communications technology, in all residency training locations through December 31, 2024.

As stated in the CY 2024 PFS final rule ( 88 FR 78880 ), we are concerned that an abrupt transition to our pre-PHE policy may present a barrier to access to many services. We also understand that teaching physicians have gained clinical experience providing services involving residents with virtual presence during the PHE for COVID-19 and could help us to identify circumstances where the teaching physician can routinely provide sufficient personal and identifiable services to the patient through their virtual presence during the key portion of the Medicare telehealth service. We sought comment and information to help us consider other clinical treatment situations where it may be appropriate to continue to permit the virtual presence of the teaching physician, while continuing to support patient safety, meeting the clinical needs for all patients, and ensuring burden reduction without creating risks to patient care or increasing opportunities for fraud. As summarized in the CY 2024 PFS final rule ( 88 FR 78881 through 78882 ), commenters encouraged us to establish this policy permanently and include in-person services to promote access to care, stated that teaching physicians should be allowed to determine when their virtual presence would be clinically appropriate, based on their assessment of the patient's needs and the competency level of the resident. While we continue to consider clinical scenarios where it may be appropriate to permit the virtual presence of the teaching physician, we are proposing to continue our current policy to allow teaching physicians to have a virtual presence for purposes of billing for services furnished involving residents in all teaching settings, but only when the service is furnished virtually (for example, a 3-way telehealth visit, with the patient, resident, and teaching physician in separate locations). This would permit teaching physicians to have a virtual presence during the key portion of the Medicare telehealth service for which payment is sought in any residency training location through December 31, 2025. The teaching physician's virtual presence would continue to require real-time observation (not mere availability) and Start Printed Page 61636 excludes audio-only technology. The documentation in the medical record must continue to demonstrate whether the teaching physician was physically present or present through audio/video real-time communications technology at the time of the Medicare telehealth service, which includes documenting the specific portion of the service for which the teaching physician was present through audio/video real-time communications technology.

The so-called primary care exception set forth at § 415.174 permits the teaching physician to bill for certain lower and mid-level complexity physicians' services furnished by residents in certain types of residency training settings even when the teaching physician is not present with the resident during the services as long as certain conditions are met, including that the services are furnished by residents with more than 6 months of training in the approved residency program; and that the teaching physician directs the care of no more than four residents at a time, remains immediately available and has no other responsibilities while directing the care, assumes management responsibility for beneficiaries seen by the residents, ensures that the services furnished are appropriate, and reviews certain elements of the services with each resident during or immediately after each visit. For a more detailed description of the list of services currently allowed under the primary care exception policy, we refer readers to the CY 2021 PFS final rule ( 85 FR 84585 through 84590 ).

We have received feedback from interested parties requesting that we permanently expand the list of services that can be furnished under the primary care exception to include all levels of E/M services and additional preventive services. These interested parties have stated that the fact that high-value primary care and preventive services are not included in the scope of the primary care exception discourages their integration in residency training in these primary care settings, which has a negative impact on physician training, patient access, and longer-term outcomes. Additionally, these interested parties have suggested that including all levels of E/M services under the primary care exception could support primary care workforce development and improve patient continuity of care without compromising patient safety; furthermore, including additional preventive services within the primary care exception would increase the utilization of high-value services.

We believe the primary care exception was intended to broaden opportunities for teaching physicians to involve residents in furnishing services under circumstances that preserve the direction of the care by the teaching physician and promote safe, high-quality patient care. As such, we are requesting information to help us consider whether and how best to expand the array of services included under the primary care exception in future rulemaking. We are interested in hearing more about the types of services that could be allowed under the primary care exception, specifically preventive services, and whether the currently required six months of training in an approved program is sufficient for residents to furnish these types of services without the presence of a teaching physician. We are seeking comment to help us consider whether adding certain preventive services or higher level E/M services to the primary care exception would hinder the teaching physician from maintaining sufficient personal involvement in the care to warrant PFS payment for the services being furnished by up to four residents at any given time. Similarly, we are requesting information on whether the inclusion in the primary care exception of specific higher-level or preventive services would impede the teaching physician's ability to remain immediately available for up to four residents at any given time, while directing and managing the care furnished by these residents.

Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001, through December 31, 2002 at $20.00, and specifies that, for telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The proposed MEI increase for CY 2025 is 3.6 percent and is based on the expected historical percentage increase of the 2017-based MEI. For the final rule, we propose to update the MEI increase for CY 2025 based on historical data through the second quarter of 2024. Therefore, for CY 2025, the proposed payment amount for HCPCS code Q3014 ( Telehealth originating site facility fee ) is $31.04. Table 9 shows the Medicare telehealth originating site facility fee and the corresponding MEI percentage increase for each applicable time period.

For information related to outpatient physical therapy, occupational therapy, speech-language pathology, diabetes self-management training (DSMT) and medical nutritional therapy (MNT) services furnished by institutional staff in hospitals and other institutional settings to beneficiaries in their homes through communication technology, please refer to section X.A. in the CY 2025 Hospital Outpatient Prospective Payment System (OPPS) proposed rule ( FR Doc. 2024-15087 ), on public inspection July 10, 2024, and publishing in the Federal Register of July 22, 2024.

Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as outlined in section II.C. of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.

In the CY 2015 PFS final rule with comment period ( 79 FR 67547 ), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule ( 81 FR 46162 ), the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of Start Printed Page 61638 new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period ( 81 FR 80170 ), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period ( 80 FR 70886 ), and re-proposed values for those codes in the CY 2017 PFS proposed rule. We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values.

As part of our obligation to establish RVUs for the PFS, we thoroughly review and consider available information including recommendations and supporting information from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the Federal Government as part of our process for establishing valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we proposed those values as recommended. Additionally, we continually engage with interested parties, including the RUC, with regard to our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process.

For each code identified in this section, we conduct a review that includes the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period ( 75 FR 73328 through 73329 ), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period ( 75 FR 73328 through 73329 ) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process.

Components that we use in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We use the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilize an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. Section 1848(c)(1)(A) of the Act specifically defines the work component as the resources that reflect time and intensity in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refine the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.

Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.

We developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an E/M service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.

Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.

Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.

The following paragraphs discuss our approach to reviewing RUC recommendations and developing Start Printed Page 61639 proposed values for specific codes. When they exist, we also include a summary of interested party reactions to our approach. We noted that many commenters and interested parties have expressed concerns over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we used to make the adjustments is derived from their survey process. We note that we are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period ( 80 FR 70933 ), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.

We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.

In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC-recommended value. If we believe that such changes in time are already accounted for in the RUC's recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options.

We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.

Several interested parties, including the RUC, have expressed general objections to our use of these methodologies and suggested that our actions in adjusting the recommended work RVUs are inappropriate; other interested parties have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule ( 81 FR 80272 through 80277 ), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule ( 81 FR 46162 ), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time.

In response to comments, in the CY 2019 PFS final rule ( 83 FR 59515 ), we clarified that terms “reference services”, “key reference services”, and “crosswalks” as described by the commenters are part of the RUC's process for code valuation. These are not terms that we created, and we do not agree that we necessarily must employ them in the identical fashion for the purposes of discussing our valuation of individual services that come up for review. However, in the interest of minimizing confusion and providing clear language to facilitate feedback from interested parties, we stated that we would seek to limit the use of the term, “crosswalk,” to those cases where we are making a comparison to a CPT code with the identical work RVU. ( 83 FR 59515 ) We note that we also occasionally make use of a “bracket” for code valuation. A “bracket” refers to when a work RVU falls between the values of two CPT codes, one at a higher work RVU and one at a lower work RVU.

We look forward to continuing to engage with interested parties and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and we will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes. Table 13 contains a list of codes and descriptors for which we are proposing work RVUs for CY 2025; this includes all codes for which we received RUC recommendations by February 10, 2024. The proposed work RVUs, work time and other payment information for all CY 2025 payable codes are available on the CMS website under downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html ).

On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code-by-code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and Start Printed Page 61640 comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the Federal Government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.

Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 14 details our refinements of the RUC's direct PE recommendations at the code-specific level. In section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), we address certain refinements that will be common across codes. Refinements to particular codes are addressed in the portions of that section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. In this proposed rule, we also note that many of the refinements listed in Table 14 result in changes under the $0.35 threshold and would be unlikely to result in a change to the RVUs.

We note that the direct PE inputs for CY 2025 are displayed in the CY 2025 direct PE input files, available on the CMS website under the downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html . The inputs displayed there have been used in developing the CY 2025 PE RVUs as displayed in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates ).

Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.

Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.

In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time will also reflect that use.

We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also noted that we believe these same assumptions will apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question will be available if the room is not being occupied by a particular patient. For additional information, we referred readers to our discussion of these issues in the CY 2012 PFS final rule with comment period ( 76 FR 73182 ) and the CY 2015 PFS final rule with comment period ( 79 FR 67639 ).

In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.

We refer readers to section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.

In some cases, the PE worksheets included with the RUC's Start Printed Page 61641 recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking ( 78 FR 74242 ), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.

The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2025 we received invoices for several new supply and equipment items. Tables 17 and 18 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units, we encourage interested parties to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encourage interested parties to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.

We remind interested parties that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 17 and 18 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that interested parties will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that interested parties are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs, and we encourage interested parties to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.

In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we include the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.

Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address code-specific refinements to clinical labor in the individual code sections.

We note that the list of services for the upcoming calendar year that are subject to the MPPR on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services; and the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap; are displayed in the public use files for the PFS proposed and final rules for each year. The public use files for CY 2025 are available on the CMS website under downloads for the CY 2025 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html . For more information regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule with comment period ( 78 FR 74261 through 74263 ).

Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 ( Pub. L. 109-171 ) (DRA) amended section 1848(b)(4) of the Act to require that, for imaging services, if—(i) The TC (including the TC portion of a global fee) of the service established for a year under the fee schedule without application of the geographic adjustment factor, exceeds (ii) The Medicare OPD fee schedule amount established under the prospective payment system (PPS) for HOPD services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under section 1833(t)(2)(D), the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor under the PFS, for the fee schedule amount for such TC for such year. As required by section 1848(b)(4)(A) of the Act, for imaging services furnished on or after January 1, 2007, we cap the TC of the PFS payment amount for the year (prior to geographic adjustment) by the Outpatient Prospective Payment System (OPPS) payment amount for the service (prior to geographic adjustment). We then apply the PFS geographic adjustment to the capped payment amount. Section 1848(b)(4)(B) of the Act defines imaging services as “imaging and computer-assisted imaging services, including X-ray, ultrasound (including echocardiography), nuclear medicine (including PET), magnetic resonance imaging (MRI), computed tomography (CT), and fluoroscopy, but excluding diagnostic and screening mammography.” For more information regarding the history of the cap on the TC of the PFS payment amount under the DRA (the “OPPS cap”), we refer readers to the CY 2007 PFS final rule with comment period ( 71 FR 69659 through 69662 ).

For CY 2025, we identified new and revised codes to determine which services meet the definition of “imaging services” as defined at section 1848(b)(4)(B) of the Act for purposes of this cap. Beginning for CY 2025, we are proposing to include the following services on the list of codes to which the OPPS cap applies: CPT codes 0868T ( High-resolution gastric electrophysiology mapping with simultaneous patient-symptom profiling, with interpretation and Start Printed Page 61642 report), 0876T (Duplex scan of hemodialysis fistula, computer-aided, limited (volume flow, diameter, and depth, including only body of fistula) ), 74263 (Computed tomographic (ct) colonography, screening, including image postprocessing), 9X059 ( Computerized ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]), posterior segment, with interpretation and report, unilateral or bilateral; retina including OCT angiography ), 93X94 ( Vasoreactivity study performed with transcranial Doppler study of intracranial arteries, complete (List separately in addition to code for primary procedure) ), 93X95 ( Emboli detection without intravenous microbubble injection performed with transcranial Doppler study of intracranial arteries, complete (List separately in addition to code for primary procedure) ), and 93X96 ( Venous-arterial shunt detection with intravenous microbubble injection performed with transcranial Doppler study of intracranial arteries, complete (List separately in addition to code for primary procedure) ). We believe that these codes meet the definition of imaging services under section 1848(b)(4)(B) of the Act, and thus, should be subject to the OPPS cap.

In the CY 2024 PFS final rule ( 88 FR 78894 ), we noted that in response to the CY 2024 PFS proposed rule, commenters requested that CMS remove CPT code 92229 ( Imaging of retina for detection or monitoring of disease; point-of-care autonomous analysis and report, unilateral or bilateral ) from the OPPS cap list because it does not include an associated PC or physician interpretation and it is primarily utilized in the physician office setting. We are soliciting comment on the appropriateness of applying the OPPS cap to services such as this for which the interpretation component is not captured by work RVUs, and the service is not split into technical and professional components. We are more broadly evaluating how services involving assistive technologies are most accurately valued. We note that the OPPS rate for this service is currently higher than what would be paid in a physician office setting, and therefore the OPPS cap does not currently apply to CPT code 92229 as of 2024.

In September 2023, the CPT Editorial Panel approved the creation of eight new CPT codes to describe skin cell suspension autograft (SCSA) procedures. The code set includes a 000-day global base code (CPT code 15XX1 ( Harvest of skin for skin cell suspension autograft; first 25 sq cm or less )) and an add-on code (CPT code 15XX2 ( Harvest of skin for skin cell suspension autograft; each additional 25 sq cm or part thereof (List separately in addition to code for primary procedure) )) describing the harvesting component of the procedure, an XXX global base code (CPT code 15XX3 ( Preparation of skin cell suspension autograft, requiring enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; first 25 sq cm or less of harvested skin ) and an add-on code (CPT code 15XX4 ( Preparation of skin cell suspension autograft, requiring enzymatic processing, manual mechanical disaggregation of skin cells, and filtration; each additional 25 sq cm of harvested skin or part thereof (List separately in addition to code for primary procedure) )) describing the preparation component of the procedure, and two 090-day global base codes and two add-on codes for the application component to distinguish between body areas: trunk, arms, and legs with CPT codes 15XX5 ( Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing, trunk, arms, legs; first 480 sq cm or less ) and 15XX6 ( Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing, trunk, arms, legs; each additional 480 sq cm or part thereof (List separately in addition to code for primary procedure) ); and face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, or multiple digits with CPT codes 15XX7 ( Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 480 sq cm or less ) and 15XX8 ( Application of skin cell suspension autograft to wound and donor sites, including application of primary dressing, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 480 sq cm or part thereof (List separately in addition to code for primary procedure) ).

We disagree with the RUC-recommended work RVUs of 3.00, 2.00, 2.51, 2.00, 10.97, 2.50, 12.50, and 3.00 for CPT codes 15XX1 through 15XX8, respectively, and are proposing contractor-pricing for these CPT codes due to concerns with the coding structure of the code family and the total physician time that results when these codes are billed multiple times on the same date of service for the typical patient.

We note that our concerns with these CPT codes are expansive. Firstly, we note that these CPT codes represent a segmentation of a single service that is performed sequentially on the same date of service. We are seeking comment on whether the segmentation of the harvest, preparation, and application is necessary when these are sequential service parts of one episode of care, and could be simplified by having just two codes that encompass all three service parts (harvest, preparation, and application), to differentiate the two different application areas. We also are soliciting comment on the base and add-on codes' incremental square centimeters, considering that the typical size treatment area described in the vignettes could result in the add-on codes being billed multiple times, particularly for the base application CPT code 15XX5 and add-on CPT code 15XX6. Based on the meeting notes from the September 2023 CPT Editorial Panel meeting, the specialty society initially structured their coding request to “bundle” the service components into fewer codes, but it is unclear to us why these codes were further segmented. We believe that the very large range of intraservice times from the 33 burn surgeons may have been exacerbated by the harvest, preparation, and application components of the service being segmented in this manner. Most notably, CPT code 15XX1, which describes the first 25 sq cm of harvest, base code, had an intraservice survey time range of 5 to 480 minutes, and CPT code 15XX7, which describes the first 480 sq cm of application to the face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, had an intraservice survey time range of 10 to 360 minutes.

We note that the survey median intraservice times for CPT codes 15XX1 through 15XX8 contradict numerous publicly available sources that describe much lower times for this service or specific service parts. Most notably, the manufacturer of the RECELL Autologous Cell Harvesting Device (RECELL® System) used in this service, indicates Start Printed Page 61643 that a suspension of Spray-On Skin TM Cells using a small sample of the patient's own skin for the treatment of thermal burn wounds and full-thickness skin defects is “prepared and applied at the point of care in as little as 30 minutes.” [ 11 ] Additionally, Temple University Hospital published a news article on December 20, 2019, just 11 months after the U.S. Food and Drug Administration (FDA) approval of the RECELL® System for the treatment of acute thermal second and third-degree burns in adult patients in January 2019, stating that the entire process of skin sample collection, enzyme solution preparation, and suspension spraying/application “can take as little as 30 minutes” and “treat a wound up to 80 times the size of the donor skin sample.” [ 12 ] Additionally, an article published in Europe PubMed Central states that the procedure takes approximately 30 minutes and is performed by a burn surgeon trained in how to use RECELL® System, and does not require specialized laboratory staff. [ 13 ] Additionally, a 2007 study aimed at comparing the results from the RECELL® System and the classic skin grafting for epidermal replacement in deep partial thickness burns showed a total procedure time of 59±4 minutes for the RECELL® System group. [ 14 ]

More granularly, the FDA's Instructions for Use of the RECELL® Autologous Cell Harvesting Device state that “if a skin sample is harvested and processed according to these instructions, it should require between 15 and 30 minutes of contact with the Enzyme”. [ 15 ] Additionally, the National Institute for Health and Care Excellence (NICE) produced guidance on using the RECELL® System based on the consideration of evidence submitted and the views of expert advisers, and stated that the harvested skin is added to the proprietary enzyme solution in a processing unit and heated for 15 to 30 minutes to disaggregate the cells. The skin is then removed and scraped with a scalpel to develop a plume of cells. These cells are added to a buffer solution, aspirated and filtered to create a cell suspension that contains keratinocytes, melanocytes, fibroblasts and Langerhans cells. [ 16 ] This correlates to the preparation component of the service described by CPT codes 15XX3 and 15XX4, for which the RUC recommended the survey median time of 33 and 28 minutes, respectively.

We believe that the publicly available sources that make representations about the total service and preparation times contradict the RUC-recommended median times based on the survey of 33 burn surgeons. Moreover, when we considered how the add-on CPT codes 15XX2, 15XX4, 15XX6, and 15XX8 would be billed based on the typical patient described in the vignettes, we believe the survey times are inflated compared to the publicly available sources, likely due to how the survey respondents considered the service given the segmentation of the code set. For example, the vignette for CPT code 15XX5 describing the application to the trunk, arms, and legs says “A 35-year-old male sustained partial-thickness thermal burns on his trunk and arms measuring 3,600 sq cm. A skin cell suspension autograft is applied to 480 sq cm of the wound bed.” Of the 33 burn surgeons surveyed, 96 percent found this vignette to be typical. Given the typical sq cm application area of 3,600 sq cm and the expansion ratio of harvested and prepared skin to treatment skin for application of 1:80, the typical episode of care would constitute 1 unit of both CPT codes 15XX1 and 15XX2 for harvesting, 1 unit of both CPT codes 15XX3 and 15XX4 for preparation, 1 unit of CPT code 15XX5 for the first 480 sq cm of application, and 7 units of CPT code 15XX6 for the remaining 3,120 sq cm of application area. When the RUC-recommended intraservice and total times (not including the post-operative visit time for CPT code 15XX5) for all the units billed on the same date of service as sequential service parts are summed, the intraservice time totals to 399 minutes and total time (not including the post-operative visit time included in the global period for CPT code 15XX5) totals to 529 minutes. The intraservice time total alone is nearly 6 and 2/3 hours.

We note the RUC recommended that CPT codes 15XX1 through 15XX8 be placed on the New Technology list to be re-reviewed by the RUC for both work and PE for the September 2026 or January 2027 RUC meeting when 2025 Medicare utilization data is available, and at that time, the RUC would consider if other specialties were performing the service and if the service was performed in the non-facility setting. We look forward to re-reviewing these CPT codes when recommendations are re-submitted with more robust and inclusive survey data. In the meantime, we encourage the reconsideration of the family's coding structure by the CPT Editorial Panel given the challenging aspects of this service, including the fact that the current coding structure represents a severely segmented single episode of care with troublesome billing patterns for the typical patient, particularly for the add-on CPT code 15XX6 describing the additional 480 sq cm increments of application on the trunk, arms, and legs. This code is particularly concerning because the coding structure of the family requires 7 units of add-on CPT code 15XX6 to be billed for the typical patient. Similarly, the typical patient described in the vignettes for this family of codes would require 3 units of add-on CPT code 15XX8 due to the coding structure.

We are also seeking feedback on the recommended global period for CPT code 15XX3. The RUC recommended an XXX global period, which indicates that the global concept does not apply, but we believe a 000-day global period, indicating an endoscopic or minor procedure with related preoperative and postoperative relative values on the day of the procedure only in the fee schedule payment amount, may be more appropriate given the nature of the service (which is intertwined with the other codes in the series) and that the entire service cannot be completed without 15XX3. This would allow the entire service to run within a surgical global period.

We note that we believe contractor-pricing is appropriate for CPT codes 15XX1 through 15XX8 until reconsideration of the coding structure and re-survey is complete, given the concerning aspects of the CPT codes. We note that this service is currently billed for using contractor-priced CPT code 17999 ( Unlisted procedure, skin, mucous membrane and subcutaneous Start Printed Page 61644 tissue ) and the eight new codes are expected to be a very low utilization.

In September 2022, the RUC referred CPT codes 26480 and 25447 to the CPT Editorial Panel for a code bundling solution. In May 2023, the CPT Editorial Panel approved a new bundled code (CPT code 2X005) to report intercarpal or carpometacarpal joint suspension arthroplasty, including transfer or transplant of tendon, with interposition when performed while CPT code 25447 was revised to clarify that the code only included interposition of a tendon and not suspension. This family of codes was surveyed for the September 2023 RUC meeting.

We disagree with the RUC-recommended work RVU of 9.50 for CPT code 25310 ( Tendon transplantation or transfer, flexor or extensor, forearm and/or wrist, single; each tendon ) and we are instead proposing a work RVU of 9.00 based on the survey 25th percentile result. In reviewing CPT code 25310, we noted that the recommended intraservice time was unchanged at 60 minutes in the new survey; however, the RUC-recommended work RVU is increasing from the current 8.08 to 9.50. Although we do not imply that changes in work time as reflected in survey values must equate to a one-to-one or linear change in the valuation of work RVUs, we believe that since the two components of work are time and intensity, increases in the recommended work RVU should typically be reflected in increases in the surveyed work time. We recognize that the total time for CPT code 25310 is increasing from 235 minutes to 263 minutes (an increase of 12 percent) due to changes in the code's post-operative office visits which will now take place at a higher level. However, this again does not match the increase in the recommended work RVU, which is increasing from 8.08 to 9.50 (approximately 18 percent). We believe that it would be more accurate to propose the survey 25th percentile work RVU of 9.00 for CPT code 25310 which matches this increase in the total work time. We also note that the intensity of CPT code 25310 is decreasing, not increasing, as recommended by the RUC which further suggests that a work RVU of 9.50 would not be appropriate for this code given the surveyed work times.

We disagree with the RUC-recommended work RVU of 11.14 for CPT code 25447 ( Arthroplasty, intercarpal or carpometacarpal joints; interposition (eg, tendon) ) and we are instead proposing a work RVU of 10.50 based on the survey 25th percentile result. In reviewing CPT code 25447, we noted that the recommended intraservice time was decreasing from 100 minutes to 75 minutes in the new survey; however, the RUC recommended maintaining the current work RVU of 11.14. Although we do not imply that changes in work time as reflected in survey values must equate to a one-to-one or linear change in the valuation of work RVUs, we believe that since the two components of work are time and intensity, decreases in the surveyed work time should typically be reflected in decreases to the work RVU. We recognize that the total time for CPT code 25447 is slightly increasing from 278 minutes to 281 minutes (an increase of about 1 percent) due to changes in the code's post-operative office visits which will now take place at a higher level. However, we believe that the sizable decrease in surveyed intraservice work time (a reduction of approximately 33 percent) better supports proposing the survey 25th percentile work RVU of 10.50 instead of maintaining the current work RVU of 11.14. We also disagree with the RUC that the intensity of CPT code 25447 is unchanged due to increases in the post-operative work; we believe that the sizable decrease in surveyed intraservice work time indicates a modest decrease in intensity. We note again that the intensity of CPT code 25310 is decreasing, not increasing, as recommended by the RUC which suggests that a similar pattern is likely taking place with clinically similar procedures elsewhere in the same code family.

We disagree with the RUC-recommended work RVU of 13.90 for CPT code 2X005 ( Arthroplasty, intercarpal or carpometacarpal joints; suspension, including transfer or transplant of tendon, with interposition, when performed ) and we are instead proposing a work RVU of 11.85 based on the survey 25th percentile result. We note that the RUC typically values new codes such as CPT code 2X005 using this survey 25th percentile work RVU as opposed to the survey median work RVU that it recommended. The RUC's recommendations stated that CPT code 2X005 should be valued higher than CPT code 25447 due to having higher intensity, a relationship which is preserved at our proposed work RVUs of 11.85 and 10.50 respectively. The RUC also stated in its recommendations that CPT code 2X005 should be valued higher than reference CPT code 29828 ( Arthroscopy, shoulder, surgical; biceps tenodesis ) because it has more intraservice time and total work time. However, the RUC also stated elsewhere in its recommendations that the arthroscopy described by CPT code 29828 is more intense than the arthroplasty procedures described by this family of codes, which we believe supports CPT code 29828 having a higher work RVU despite its lower work times. Based on this information, we believe that proposing the survey 25th percentile work RVU of 11.85 is the most accurate valuation for CPT code 2X005.

We disagree with the RUC-recommended work RVU of 9.50 for CPT code 26480 ( Transfer or transplant of tendon, carpometacarpal area or dorsum of hand; without free graft, each tendon ) and we are instead proposing a work RVU of 9.00 based on the survey 25th percentile result. In reviewing CPT code 26480, we noted that the recommended intraservice time was unchanged at 60 minutes in the new survey; however, the RUC-recommended work RVU is increasing from the current 6.90 to 9.50. Although we do not imply that changes in work time as reflected in survey values must equate to a one-to-one or linear change in the valuation of work RVUs, we believe that since the two components of work are time and intensity, increases in the recommended work RVU should typically be reflected in increases in the surveyed work time. We recognize that the total time for CPT code 26480 is increasing from 227 minutes to 263 minutes (an increase of 16 percent) due to changes in the code's post-operative office visits which will now take place at a higher level. However, this again does not match the increase in the recommended work RVU, which is increasing from 6.90 to 9.50 (approximately 38 percent). We believe that it would be more accurate to propose the survey 25th percentile work RVU of 9.00 for CPT code 26480 which more closely matches this increase in the total work time. We also note that CPT codes 25310 and 26480 were surveyed as having identical work times and identical survey 25th percentile and survey median work RVUs. We concur with the RUC that these two codes should be valued at the same work RVU, however we continue to believe that the survey 25th percentile work RVU of 9.00 is a more accurate choice in both cases. We are proposing the RUC-recommended direct PE inputs for all four codes in the family without refinement. Start Printed Page 61645

In September 2023, the CPT Editorial Panel deleted four category III codes (0537T-0540T) and approved the addition of four new codes (3X018-3X021) that describe only steps of the complex CAR-T Therapy process performed and supervised by physicians. The RUC recommended four different work RVUs for codes 3X018, 3X019, 3X020, and 3X021 and only recommended direct PE values for code 3X021.

For CPT code 3X018 (Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day) the RUC recommended a work RVU of 1.94. For CPT code 3X019 ( Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage) ) the RUC recommended a work RVU of 0.79. For CPT code 3X021 ( Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous ) the RUC recommended a work RVU of 3.00. For CPT code 3X020 ( Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration ) the RUC recommended a work RVU of 0.80 and for CPT code 3X020, we are proposing the RUC-recommended work RVU of 0.80. We are proposing the RUC-recommended work RVUs for CPT codes 3X018, 3X019, and 3X021 respectively.

As mentioned previously, the RUC recommended direct PE values for only one code, CPT code 3X021, and the RUC recommended that the non-facility PE RVU for CPT codes 3X018-3X020 should be contractor-priced. However, contractor pricing can only be applied at the whole code level, not to a single component of the valuation. Therefore, for CPT codes 3X018-3X020 we are treating these codes as having no recommended direct PE values and are seeking comment on direct PE values for these codes. We are proposing the RUC-recommended direct PE inputs for CPT code 3X021.

In the CY 2024 PFS final rule, we finalized CPT codes 36514 ( Therapeutic apheresis; for plasma pheresis ), 36516 ( Therapeutic apheresis; with extracorporeal immunoadsorption, selective adsorption or selective filtration and plasma reinfusion ), and 36522 ( Photopheresis, extracorporeal ) as potentially misvalued, as we believed there may have been a possible disparity with the clinical labor type ( 88 FR 78848 ). As a result, the PE clinical labor type was reviewed for these three codes at the January 2024 RUC meeting, with no work review. The PE Subcommittee and the RUC agreed that clinical staff code L042A (RN/LPN) did not appropriately represent the work of an Apheresis Nurse Specialist. There is not a clinical staff code for an Apheresis Nurse Specialist; however, the RUC agreed with the specialty societies' recommendation that the training and experience of an oncology nurse (clinical staff code L056A, RN/OCN) would more accurately reflect the work of an apheresis nurse for these CPT codes. The RUC submitted new PE recommendations for these three codes based on the use of the L056A clinical labor type.

We are proposing the RUC-recommended direct PE inputs for CPT codes 36514, 36516, and 36522 without refinement. The RUC did not make recommendations and we are not proposing any changes to the work RVU for CPT codes 36514, 36516, and 36522.

In May 2023, the CPT Editorial Panel created five new codes to describe the sum of the maximum length of intra-abdominal (that is, peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s) excised or destroyed: CPT code 4X015 ( Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 5 cm or less ), CPT code 4X016 ( Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 5.1 to 10 cm ), CPT code 4X017 ( Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 10.1 to 20 cm ), CPT code 4X018 ( Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); 20.1 to 30 cm ), and CPT code 4X019 ( Excision or destruction, open, intra-abdominal (i.e., peritoneal, mesenteric, retroperitoneal), primary or secondary tumor(s) or cyst(s), sum of the maximum length of tumor(s) or cyst(s); greater than 30 cm ). These new CPT codes will replace existing CPT codes 49203 ( Excision or destruction, open, intra-abdominal tumors, cysts or endometriomas, 1 or more peritoneal, mesenteric, or retroperitoneal primary or secondary tumors; largest tumor 5 cm diameter or less ), 49204 ( Excision or destruction, open, intra-abdominal tumors, cysts or endometriomas, 1 or more peritoneal, mesenteric, or retroperitoneal primary or secondary tumors; largest tumor 5.1-10.0 cm diameter ), and 49205 ( Excision or destruction, open, intra-abdominal tumors, cysts or endometriomas, 1 or more peritoneal, mesenteric, or retroperitoneal primary or secondary tumors; largest tumor greater than 10.0 cm diameter ) that described tumor excision or destruction based on the size of the single largest tumor, cyst, or endometrioma removed, no matter the number of tumors. For CY 2025, the RUC recommended a work RVU of 22.00 for CPT code 4X015, a work RVU of 28.65 for CPT code 4X016, a work RVU of 34.00 for CPT code 4X017, a work RVU of 45.00 for CPT code 4X018, and a work RVU of 55.00 for CPT code 4X019.

We are proposing the RUC-recommended work RVUs of 22.00 for CPT code 4X015, 28.65 for CPT code 4X016, and 34.00 for CPT code 4X017.

We disagree with the RUC-recommended work RVU of 45.00 for CPT code 4X018 and we are proposing a work RVU of 40.00 based on the survey 25th percentile. Compared to the predecessor CPT code 49205, the intra-service time ratio for CPT code 4X018 suggests a work RVU of 41.51 and the total time ratio suggests a work RVU of 38.02. These changes in surveyed work time as compared with predecessor CPT code 49205 suggest that the recommended work RVU of 45.00 is inappropriately high. We also note that the RUC recommended the survey 25th percentile work RVU for CPT codes 4X015, 4X016, and 4X017. Therefore, we believe that proposing a work RVU of 40.00 for CPT code 4X018 keeps the valuation consistent with the other CPT codes in this family. Our proposed work RVU of 40.00 for CPT code 4X018 is supported by the following reference CPT codes with similar intra-service time (310 minutes) and similar total time (814 minutes): reference CPT code 69970 ( Removal of tumor, temporal bone ) with a work RVU of 32.41 with 330 minutes intra-service time and 793 minutes of total time, and reference CPT code 33864 ( Ascending aorta graft, with cardiopulmonary bypass with valve suspension, with coronary reconstruction and valve-sparing aortic root remodeling (e.g., David Procedure, Start Printed Page 61646 Yacoub Procedure) ) with a work RVU of 60.80 with 300 minutes of intra-service time and 838 minutes of total time. We believe the proposed work RVU of 40.00 is a more appropriate value overall than 45.00 when compared to the range of codes with similar intra-service time and similar total time.

We disagree with the RUC-recommended work RVU of 55.00 for CPT code 4X019 and we are proposing a work RVU of 50.00 based on the survey 25th percentile. Compared to the predecessor CPT code 49205, the intra-service time ratio for CPT code 4X019 suggests a work RVU of 48.21 and the total time ratio suggests a work RVU of 48.86. These changes in surveyed work time as compared with predecessor CPT code 49205 suggest that the recommended work RVU of 55.00 is inappropriately high. We also note again that the RUC recommended the survey 25th percentile work RVU for CPT codes 4X015, 4X016, and 4X017. Therefore, we believe that proposing a work RVU of 50.00 for CPT code 4X019 keeps the valuation consistent with the other CPT codes in this family. Our proposed work RVU of 50.00 for CPT code 4X019 is supported by the following reference CPT codes with similar intra-service time (360 minutes) and similar total time (1,046 minutes): reference CPT code 61598 ( Transpetrosal approach to posterior cranial fossa, clivus or foramen magnum, including ligation of superior petrosal sinus and/or sigmoid sinus ) with a work RVU of 36.53 with 377.7 minutes intra-service time and 1,048.1 minutes of total time, and reference CPT code 47140 ( Donor hepatectomy (including cold preservation), from living donor; left lateral segment only (segments II and III) ) with a work RVU of 59.40 with 355 minutes of intra-service time and 1,073 minutes of total time. We believe the proposed RVU of 50.00 is a more appropriate value overall than 55.00 when compared to the range of codes with similar intra-service time and similar total time.

We also note that the RUC's recommendations for the first three codes in the family (CPT codes 4X015-4X017) maintained the same amount of intensity as their respective predecessor codes, and in fact slightly decreased in intensity in the case of CPT codes 4X015 and 4X016. However, the RUC recommended a notable increase in intensity for CPT codes 4X018 and 4X019 over predecessor code 49205 due to its selection of the survey median work RVU in both cases. We do not believe that this increase in intensity for CPT codes 4X018 and 4X019 is warranted due to their clinical similarities to the previous coding in the family, especially given that CPT code 49205 had the lowest intensity in the family. We believe that this intensity argument further supports our choice to propose the survey 25th percentile work RVU for these two codes, matching the RUC recommendations for CPT code 4X015-4X017.

We are proposing the RUC-recommended direct PE inputs for CPT codes 4X015, 4X016, 4X017, 4X018, and 4X019 without refinement.

In September 2023, the CPT Editorial Panel created two Category I CPT codes to describe the insertion or removal of a temporary device to remodel the bladder neck and prostate using pressure to create necrosis and relieve lower urinary tract symptoms (LUTS) secondary to benign prostate hyperplasia (BPH). These two new 000-day global Category I codes were surveyed and reviewed for the January 2024 RUC meeting.

At the January 2024 RUC meeting, the specialty society indicated that CPT code 5XX05's survey 25th percentile work RVU of 3.91 was too high for this procedure compared to other services in the physician fee schedule with similar intra-service time. The specialty society recommended, and the RUC agreed that the recommended work RVU for CPT code 5XX05 should be crosswalked to CPT code 52284 ( Cystourethroscopy, with mechanical urethral dilation and urethral therapeutic drug delivery by drug-coated balloon catheter for urethral stricture or stenosis, male, including fluoroscopy, when performed ). Because these procedures are similar in intensity and both require precise placement of an intraurethral device, we concur with the RUC and we are proposing the RUC recommended work RVU of 3.10 for CPT code 5XX05.

At the January 2024 RUC meeting, the specialty society indicated that CPT code 5XX06's survey 25th percentile work RVU of 2.00 was too high for this procedure compared to other services in the physician fee schedule with similar intra-service time. The specialty society recommended, and the RUC agreed, that CPT code 5XX06 should have a direct work RVU crosswalk to CPT code 27096 ( Injection procedure for sacroiliac joint, anesthetic/steroid, with image guidance (fluoroscopy or CT) including arthrography when performed ). We are proposing the RUC recommended work RVU of 1.48 for CPT code 5XX06.

We are also proposing the RUC-recommended direct PE inputs for CPT codes 5XX05 and 5XX06 without refinement. However, we note possible duplications in two of the supply items within CPT code 5XX05. Specifically, supply item SB027 ( gown, staff, impervious ) is already included in supply item SA042 ( pack, cleaning and disinfecting, endoscope ), and supply item SB024 ( gloves, sterile ) is included in supply items SA058 (pack, urology cystoscopy visit). We are seeking comments on whether a total of three SB027 impervious staff gowns and two SB024 pairs of sterile gloves would be typical and necessary when providing this procedure.

At the April 2023 CPT Editorial Panel meeting, three new CPT codes were approved for MRI-monitored transurethral ultrasound ablation (TULSA). These codes were surveyed for the September 2023 RUC meeting and recommendations submitted to CMS for inclusion in the CY 2025 PFS proposed rule.

For CY 2025, we are proposing the RUC-recommended work RVUs for all three CPT codes. However, we note that interested parties may have concerns regarding the experience of the survey respondents and the intra-service times provided in the survey data. We welcome commenters to provide additional data that we could consider in the valuation of the work and direct PE inputs for these CPT codes. We are proposing a work RVU of 4.05 for CPT code 5X006 ( Insertion of transurethral ablation transducers for delivery of thermal ultrasound for prostate tissue ablation, including suprapubic tube placement during the same session and placement of an endorectal cooling device, when performed ), a work RVU of 9.80 for CPT code 5X007 ( Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation ), and a work RVU of 11.50 for CPT code 5X008 ( Ablation of prostate tissue, transurethral, using thermal ultrasound, including magnetic resonance imaging guidance for, and monitoring of, tissue ablation; with insertion of transurethral ultrasound transducers for delivery of the thermal ultrasound, including suprapubic tube placement and placement of an endorectal cooling device, when performed ). We are also proposing the RUC-recommended direct PE inputs for CPT codes 5X006, 5X007, and 5X008 without refinement. Start Printed Page 61647

In the CY 2024 PFS final rule, we finalized CPT Code 59200 ( Insertion of cervical dilator (e.g., laminaria, prostaglandin) (separate procedure) ) as potentially misvalued. The code is to be used to report the total duration of time spent on a patient history and physical, reviewing lab resulting, discussing risk and benefits of the procedure, obtaining consent, performing the procedure, and assessing the patient post-procedure. The RUC reviewed the work RVU and PE inputs for CPT code 59200 at their January 2024 meeting. We are proposing the RUC-recommended work RVU of 1.20 for CPT code 59200. We are also proposing the RUC-recommended direct PE inputs for CPT code 59200 without refinements.

In September 2023, the CPT Editorial Panel created a new Category I code to describe magnetic resonance image guided high intensity focused ultrasound intracranial ablation for treatment of a severe central tremor that is recalcitrant to other medical treatments. This service is typically performed by a neurosurgeon without the involvement of a separate radiologist. This new code replaces the existing Category III code 0398T.

We are not proposing the RUC-recommended work RVU of 18.95 for CPT code 6XX00 and are instead proposing a work RVU of 16.60 based on a crosswalk to CPT code 61626 ( Transcatheter permanent occlusion or embolization (e.g., for tumor destruction, to achieve hemostasis, to occlude a vascular malformation), percutaneous, any method; non-central nervous system, head or neck (extracranial, brachiocephalic branch) ), which describes a similar tumor destruction service that has similar time and intensity values to this service, and we support this value by referencing CPT code 33889 ( Open subclavian to carotid artery transposition performed in conjunction with endovascular repair of descending thoracic aorta, by neck incision, unilateral ) and 33894 ( Endovascular stent repair of coarctation of the ascending, transverse, or descending thoracic or abdominal aorta, involving stent placement; across major side branches ). We do not believe that this service is significantly more intense than the key reference codes, CPT codes 61736 ( Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; single trajectory for 1 simple lesion ) and 61737 ( Laser interstitial thermal therapy (LITT) of lesion, intracranial, including burr hole(s), with magnetic resonance imaging guidance, when performed; multiple trajectories for multiple or complex lesion(s) ), as the RUC-recommended work value implies. Our proposed work RVU of 16.60 for CPT code 6XX00 largely matches the intensity of CPT code 61736 which we believe is a more accurate valuation for this service, as opposed to the RUC recommendation which would have significantly more intensity.

We are proposing the RUC-recommended direct PE inputs for CPT code 6XX00 without refinement.

In January 2024, the RUC surveyed codes 6XX01 ( Ablation of 1 or more thyroid nodule(s), one lobe or the isthmus, percutaneous, including imaging guidance, radiofrequency ) and its respective add-on code 6XX02 ( Ablation of 1 or more thyroid nodule(s), additional lobe, percutaneous, with imaging guidance, radiofrequency (List separately in addition to code for primary service ) and recommended both work RVUs and PE values for this code family.

For CPT code 6XX01, the RUC recommended a work RVU of 5.75 and we are proposing the RUC-recommended work RVU of 5.75.

For add-on code CPT 6XX02, the RUC recommended a work RVU of 4.25 and we are proposing the RUC-recommended work RVU for this code. We are also proposing the RUC-recommended direct PE values for both codes 6XX01 and 6XX02.

In September 2023, the CPT Editorial Panel created six new Category I CPT codes, CPT code 6XX07 ( Thoracic fascial plane block, unilateral; by injection(s), including imaging guidance, when performed ), 6XX08 ( Thoracic fascial plane block, unilateral; by continuous infusion(s), including imaging guidance, when performed ), 6XX09 ( Thoracic fascial plane block, bilateral; by injection(s), including imaging guidance, when performed ), 6XX10 ( Thoracic fascial plane block, bilateral; by continuous infusion(s), including imaging guidance, when performed ), 6XX11 ( Lower extremity fascial plane block, unilateral; by injection(s), including imaging guidance, when performed ), and 6XX12 ( Lower extremity fascial plane block, unilateral; by continuous infusion(s), including imaging guidance, when performed ) to report thoracic or lower extremity fascial plane blocks, typically used for post-operative pain management. Four existing CPT codes describing transversus abdominis plane (TAP) blocks, 64486 ( Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block) unilateral; by injection(s) (includes imaging guidance, when performed) ), 64487 ( Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block) unilateral; by continuous infusion(s) (includes imaging guidance, when performed) ), 64488 ( Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block) bilateral; by injections (includes imaging guidance, when performed) ) 64489 ( Transversus abdominis plane (TAP) block (abdominal plane block, rectus sheath block) bilateral; by continuous infusions (includes imaging guidance, when performed) ), were included as part of this code family for RUC review in January 2024.

We are proposing the RUC-recommended work RVU for all ten codes in this family. We are proposing a work RVU of 1.50 for CPT code 6XX07, 1.74 for CPT code 6XX08, 1.67 for CPT code 6XX09, 1.83 for CPT code 6XX10, 1.34 for CPT code 6XX11, 1.67 for CPT code 6XX12, 1.20 for CPT code 64486, 1.39 for CPT code 64487, 1.40 for CPT code 64488, and 1.75 for CPT code 64489.

We are also proposing the RUC recommended direct PE inputs for CPT codes 6XX08, 6XX09, 6XX10, 6XX12, 64487, 64488, and 64489. We disagree with one of the RUC recommended direct PE inputs for CPT codes 6XX07, 6XX11, and 64486. The RUC stated they believe that there is a rounding error in the CA019 clinical labor time, “Assist physician or other qualified healthcare professional—directly related to physician work time (67%)”, for these three codes. We disagree with the RUC that there are rounding errors in these codes and we are proposing to maintain the current 7 minutes of CA019 clinical labor time for CPT codes 6XX07, 6XX11, and 64486. We note that this matches the pattern of CA019 clinical labor time for the rest of the codes in the family, which remained the same or slightly decreased in each case. This refinement to the CA019 clinical labor time also means that we are proposing a decrease of 0.5 minutes to the equipment time for the stretcher (EF018) and 3-channel ECG Start Printed Page 61648 (EQ011) which decreases from 25.5 to 25 minutes for these three codes. We are proposing all of the other RUC-recommended direct PE inputs for CPT codes 6XX07, 6XX11, and 64486 without refinement.

In April 2022, the RUC approved the use of SG007 ( adhesive, skin (Dermabond) ) for CPT code 64590 ( insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver ) and 64595 ( revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array ). In April 2023, the PE Subcommittee reviewed the following six codes on the Medicare Physician Fee Schedule 64590, 64595, G0168, G0516, G0517, G0518 that utilize Dermabond (supply code S6007) in order to identify justification for its use versus the generic version and present its findings to the RUC for approval. The RUC reviewed all six codes for PE only and did not submit work recommendations.

For CPT codes 64590 and 64595 and HCPCS code G0168 ( Wound closure utilizing tissue adhesive(s) only ), the RUC recommends that CMS remove the supply input SG007 adhesive, skin (Dermabond) and add one unit of SH076 adhesive, cyanoacrylate (2ml uou). We are proposing the RUC-recommended direct PE inputs for CPT codes 64590 and 64595 and HCPCS code G0168. Similarly, for HCPCS codes G0516 ( Insertion of non-biodegradable drug delivery implants, 4 or more (services for subdermal rod implant ), G0517 ( Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants ), and G0518 ( Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants ), the RUC recommends that CMS remove the supply input SG007 adhesive, skin (Dermabond) and add one unit of SH076 adhesive, cyanoacrylate (2ml uou). We are proposing the RUC-recommended direct PE inputs for HCPCS codes G0516-G0518.

In April 2023, the CPT Editorial Panel deleted three related Category III CPT codes, CPT code 0616T ( Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed; without removal of crystalline lens or intraocular lens, without insertion of intraocular lens ), CPT code 0617T ( with removal of crystalline lens and insertion of intraocular lens ), and CPT code 0618T (with secondary intraocular lens placement or intraocular lens exchange). At the same time, CPT created a new Category I code 6X004 ( Implantation of iris prosthesis, including suture fixation and repair or removal of iris, when performed ) which describes insertion of an artificial iris into an eye with a partial or complete iris defect due to a congenital defect or surgical or non-surgical trauma. The new Category I CPT code 6X004 replaced the three Category III codes to simplify reporting. Concurrent with these updates, the RUC surveyed the two other 90-day global iris repair codes, CPT code 66680 ( Repair of iris, ciliary body (as for iridodialysis) ) and CPT code 66682 ( Suture of iris, ciliary body (separate procedure) with retrieval of suture through small incision (e.g., McCannel suture) ).

We disagree with the RUC-recommended work RVU of 10.25 for CPT code 66680. We are proposing a work RVU of 7.97 for CPT code 66680 based on a crosswalk to CPT code 67904 ( Repair of blepharoptosis; (tarso) levator resection or advancement, external approach ). When we reviewed CPT code 66680, we found that the RUC recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time of 45 minutes and similar total time around 182 minutes. The total time ratio between the current time of 159 minutes and the recommended time established by the RUC survey of 182 minutes equals 1.145 percent. This ratio, 1.145 percent, when applied to the current work RVU of 6.39 would suggest a work RVU of 7.31 which is far below the RUC's recommended work RVU of 10.25. Based on this total time ratio, we believe a more appropriate work valuation for CPT code 66680 is 7.97 based on a crosswalk to CPT code 67904.

We disagree with the RUC-recommended work RVU of 10.87 for CPT code 66682. We are proposing a work RVU of 8.74 based on the total time ratio between the current time of 169.5 minutes and the recommended time established by the RUC survey of 202 minutes. This ratio equals 1.192 percent, and 1.192 percent of the current work RVU of 7.33 suggests a work RVU of 8.74 for CPT code 66682. When we reviewed CPT code 66682, we found that the recommended work RVU was higher than nearly all of the other 90-day global codes with similar time values. The RUC's recommended work RVU does not maintain relativity with other 90-day global period codes with the same intraservice time value of 45 minutes and similar total time of 202. We found that work RVU crosswalks to CPT codes of similar intraservice and total time were too low, such as CPT code 45171 with a work RVU of 8.13. A more appropriate work RVU for CPT code 66682 is 8.74 based on the total time ratio.

The RUC recommended a work RVU of 12.80 for CPT 6X004, the RUC survey 25th percentile result, with an intraservice time of 60 minutes and a total time of 224 minutes. We disagree with the RUC-recommended work RVU of 12.80 for CPT code 6X004. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 66682 and 6X004 is equivalent to the recommended interval of 1.93 RVUs. Therefore, we are proposing a work RVU of 10.67 for CPT code 6X004, based on the recommended interval of 1.93 additional RVUs above our proposed work RVU of 8.74 for CPT code 66682. This proposed work RVU of 10.67 falls between the work RVU values of existing codes with similar intraservice and total time values. For example, CPT code 65850 (60 minutes of intraservice time and 233 minutes of total time) has a work RVU of 11.39 and CPT code 24164 with the same intraservice time and 228 minutes of total time has a work RVU of 10.00. We believe that the work valuation of these CPT codes, which bracket our proposed work RVU of 10.67, provide additional support for our proposed valuation.

We also disagree with the RUC's recommended work RVUs for the codes in this family because they suggest that there has been a tremendous increase in intensity as compared to how these services have historically been valued. CPT code 66680 is more than doubling in intensity at the RUC's recommended work RVU of 10.25, which we do not believe to be the case given that the code descriptor remains unchanged and the surveyed intraservice work time is unchanged at 45 minutes. This same pattern holds true for CPT code 66682, which would be increasing in intensity by more than 50% at the RUC's recommended work RVU of 10.87, and which similarly has no change in its code descriptor and a modest increase in its surveyed work time. We concur that the intensity of these services has likely gone up over time, which is why we are proposing modest intensity increases for both codes, however we continue to disagree that the very Start Printed Page 61649 substantial intensity increases recommended by the RUC would be accurate for this code family. We believe that our proposed work RVUs are more in line with how these services have historically been valued and better maintain relativity with the rest of the fee schedule.

We are proposing the direct PE inputs as recommended by the RUC for all three codes in the family without refinement.

In September 2023, the CPT Editorial Panel created a new code family to describe magnetic resonance (MR) examination safety procedures and capture the physician work involving patients with implanted medical devices that require access to MR diagnostic procedures: CPT code 7XX00 ( MR safety implant and/or foreign body assessment by trained clinical staff, including identification and verification of implant components from appropriate sources (e.g., surgical reports, imaging reports, medical device databases, device vendors, review of prior imaging), analyzing current MR conditional status of individual components and systems, and consulting published professional guidance with written report; initial 15 minutes ), CPT code 7XX01 ( MR safety implant and/or foreign body assessment by trained clinical staff, including identification and verification of implant components from appropriate sources (e.g., surgical reports, imaging reports, medical device databases, device vendors, review of prior imaging), analyzing current MR conditional status of individual components and systems, and consulting published professional guidance with written report; each additional 30 minutes (List separately in addition to code for primary procedure) ), CPT code 7XX02 ( MR safety determination by a physician or other qualified health care professional responsible for the safety of the MR procedure, including review of implant MR conditions for indicated MR exam, analysis of risk versus clinical benefit of performing MR exam, and determination of MR equipment, accessory equipment, and expertise required to perform examination with written report ), CPT code 7XX03 ( MR safety medical physics examination customization, planning and performance monitoring by medical physicist or MR safety expert, with review and analysis by physician or qualified health care professional to prioritize and select views and imaging sequences, to tailor MR acquisition specific to restrictive requirements or artifacts associated with MR conditional implants or to mitigate risk of non-conditional implants or foreign bodies with written report ), CPT code 7XX04 ( MR safety implant electronics preparation under supervision of physician or other qualified health care professional, including MR-specific programming of pulse generator and/or transmitter to verify device integrity, protection of device internal circuitry from MR electromagnetic fields, and protection of patient from risks of unintended stimulation or heating while in the MR room with written report ), and CPT code 7XX05 ( MR safety implant positioning and/or immobilization under supervision of physician or qualified health care professional, including application of physical protections to secure implanted medical device from MR-induced translational or vibrational forces, magnetically induced functional changes, and/or prevention of radiofrequency burns from inadvertent tissue contact while in the MR room with written report ). For CY 2025, new CPT codes 7XX00 and 7XX01 are PE only services that represent the preparatory research and review completed by clinical staff (that is, MRI technologist and/or a medical physicist) that will be utilized by the physician or qualified health professional for the other four services (CPT codes 7XX02, 7XX03, 7XX04, and 7XX05) in this code family.

We are proposing the RUC-recommended work RVU of 0.60 for CPT code 7XX02, the work RVU of 0.76 for CPT code 7XX03, the work RVU of 0.75 for CPT code 7XX04, and the work RVU of 0.60 for CPT code 7XX05.

We are proposing the following refinements to the direct PE inputs. For CPT codes 7XX00, 7XX01, 7XX02, 7XX04, and 7XX05, we are proposing to refine the clinical labor for the CA034 activity ( Document procedure (nonPACS) (e.g., mandated reporting, registry logs, EEG file, etc.) ) performed by the MRI Technologist from 2 minutes to 1 minute. We note that the clinical labor for the CA032 activity ( Scan exam documents into PACS. Complete exam in RIS system to populate images into work queue. ) included in the direct PE inputs for reference CPT code 70543 ( Magnetic resonance (e.g., proton) imaging, orbit, face, and/or neck; without contrast material(s), followed by contrast material(s) and further sequences ) is a similar clinical labor activity and has 1 minute of time. We also note that the Medical Physicist has 1 minute of recommended clinical labor time for the CA034 activity for CPT code 7XX03. Therefore, we believe that the MRI Technologist should have the same time (1 minute) for the CA034 activity for the remaining codes in the family to maintain consistency across these services.

For CPT code 7XX01, we are proposing to refine the clinical labor for the CA021 activity ( Perform procedure/service—NOT directly related to physician work time ) from 27 minutes to 14 minutes. We believe this clinical labor time should be double the 7 minutes assigned to the CA021 activity for CPT code 7XX00. The description for CPT code 7XX00 is for the “initial 15 minutes” and CPT code 7XX01 is for “each additional 30 minutes,” that is, double the time of CPT code 7XX00. We believe that the clinical labor associated with the CA021 activity should match this pattern in which CPT code 7XX01 contains double the time of CPT code 7XX00. This proposed refinement to the CA021 clinical labor also results in a proposed decrease to the equipment time for the Technologist PACS workstation (ED050) from 45 minutes to 32 minutes.

For CPT code 7XX03, the RUC recommended 13 minutes of equipment time for the Professional PACS Workstation (ED053) listed as a Facility PE input. We believe this was an unintended technical error and we are proposing to remove this time from the direct PE inputs for CPT code 7XX03.

For CPT codes 7XX04 and 7XX05, we proposing to refine the clinical labor time for the CA024 activity ( Clean room/equipment by clinical staff ) from 2 minutes to 1 minute. According to the PE recommendations, only the new equipment code EQ412 ( Vitals monitoring system (MR Conditional) ) is being cleaned and not the entire room. We believe that 1 minute of clinical labor time would be typical for cleaning the EQ412 equipment. Our proposed clinical labor refinement also results in a proposed decrease to the equipment time for EL008 ( room, MR ) and EQ412 by 1 minute for these two codes.

For CPT code 7XX05, we are proposing to remove supply item SL082 ( impression material, dental putty (per bite block) ). We believe this was an error since the PE recommendations did not list SL082 as one of the included supplies for CPT code 7XX05 and it does not appear as a supply input for any of the other codes in the family.

As discussed in section III.K. of this proposed rule, we are proposing to exercise our authority at section Start Printed Page 61650 1861(pp)(1)(D) of the Act to update and expand coverage for colorectal cancer screening and adding coverage for the computed tomography colonography procedure. Accordingly, we are assigning an active payment status for CPT code 74263 (Computed tomographic (ct) colonography, screening, including image postprocessing). We note that, as proposed above, the OPPS cap would apply to this code, and payment for the TC of this service would be capped at the OPPS payment rate.

This code family was flagged for re-review at the April 2023 RUC meeting by the new technology/new services screen. Due to increased utilization of CPT code 76981 ( Ultrasound, elastography; parenchyma (e.g., organ) ), the entire code family was resurveyed for the September 2023 RUC meeting. We are proposing the RUC-recommended work RVUs of 0.59, 0.59, and 0.47 for CPT codes 76981, 76982 ( Ultrasound, elastography; first target lesion ), and 76983 ( Ultrasound, elastography; each additional target lesion (List separately in addition to code for primary procedure) ), respectively. We are proposing the RUC-recommended direct PE inputs for CPT codes 76981, 76982, and 76983 without refinement.

CPT code 77012 ( Computed tomography guidance for needle placement (e.g., biopsy, aspiration, injection, localization device), radiological supervision and interpretation ) was reviewed at the September 2023 RUC meeting to account for deferred updates to the vignette to reflect the typical patient until updated utilization data was available to reflect coding changes that occurred in 2019. We are proposing the RUC-recommended work RVU of 1.50 for CPT code 77012.

We are proposing to refine the equipment time for the CT room (EL007) to maintain the current time of 9 minutes. CPT code 77012 is a radiological supervision and interpretation (RS&I) procedure and there has been a longstanding convention in the direct PE inputs, shared by 38 other codes, to assign an equipment time of 9 minutes for the equipment room in these procedures. We made the same refinement in the CY 2019 PFS final rule ( 83 FR 59553 through 59554 ) and continue to believe that it would not serve the interests of relativity to increase the equipment time for the CT room in CPT code 77012 without also addressing the equipment room time for the other radiological supervision and interpretation procedures. In response to the CY 2019 proposal, several commenters stated that they agreed with CMS that other RS&I codes use the 9 minutes for room time as a precedent, but that it is specific to angiographic rooms. We agreed with the commenters that at least some portion of the procedure is performed in the CT room, but we continue to believe that it would not serve the interests of relativity to increase the equipment time for the CT room in CPT code 77012 without also addressing the equipment room time for the other radiological supervision and interpretation procedures in a more comprehensive fashion. We also disagreed with the commenters that this policy is specific to angiography rooms, as CPT codes 75989 ( Radiological guidance (i.e., fluoroscopy, ultrasound, or computed tomography), for percutaneous drainage (e.g., abscess, specimen collection), with placement of catheter, radiological supervision and interpretation ) and 77012 both employ CT rooms and currently utilize the standardized 9 minutes of equipment time, and CPT code 76080 ( Radiologic examination, abscess, fistula or sinus tract study, radiological supervision and interpretation ) employs a radiographic-fluoroscopic room with the 9 minute standard equipment time. We continue to believe that 9 minutes for EL007 is appropriate for this RS&I code, therefore, we are proposing to maintain the current equipment room time of 9 minutes for EL007 until this group of procedures can be subject to a more comprehensive review. We are proposing all other RUC-recommended direct PE inputs for CPT code 77012.

In February 2023, the CPT Editorial Panel added a new Evaluation and Management (E/M) subsection to the draft CPT codebook for Telemedicine Services. The Panel added 17 codes for reporting telemedicine E/M services: CPT code 9X075 ( Synchronous audio-video visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using total time on the date of the encounter for code selection, 15 minutes must be met or exceeded. ); CPT code 9X076 ( Synchronous audio-video visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination and low medical decision making. When using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded. ); CPT code 9X077 ( Synchronous audio-video visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination and moderate medical decision making. When using total time on the date of the encounter for code selection, 45 minutes must be met or exceeded. ); CPT code 9X078 ( Synchronous audio-video visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination and high medical decision making. When using total time on the date of the encounter for code selection, 60 minutes must be met or exceeded. (For services 75 minutes or longer, use prolonged services code 99417)); CPT code 9X079 ( Synchronous audio-video visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and straightforward medical decision making. When using total time on the date of the encounter for code selection, 10 minutes must be met or exceeded. ); CPT code 9X080 ( Synchronous audio-video visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low medical decision making. When using total time on the date of the encounter for code selection, 20 minutes must be met or exceeded. ); CPT code 9X081 ( Synchronous audio-video visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and moderate medical decision making. When using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded. ); CPT code 9X082 ( Synchronous audio-video visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and high medical decision making. When using total time on the date of the encounter for code selection, 40 minutes must be met or exceeded. ); CPT code 9X083 ( Synchronous audio-only visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination, straightforward medical decision making, and more Start Printed Page 61651 than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 15 minutes must be met or exceeded. )); CPT code 9X084 ( Synchronous audio-only visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination, low medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded.) ); CPT code 9X085 ( Synchronous audio-only visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination, moderate medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 45 minutes must be met or exceeded. ); CPT code 9X086 ( Synchronous audio-only visit for the evaluation and management of a new patient, which requires a medically appropriate history and/or examination, high medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 60 minutes must be met or exceeded. (For services 75 minutes or longer, use prolonged services code 99417)); CPT code 9X087 ( Synchronous audio-only visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination, straightforward medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 10 minutes must be exceeded.) ); CPT code 9X088 ( Synchronous audio-only visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination, low medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 20 minutes must be met or exceeded.) ); CPT code 9X089 ( Synchronous audio-only visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination, moderate medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 30 minutes must be met or exceeded.) ) CPT code 9X090 ( Synchronous audio-only visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination, high medical decision making, and more than 10 minutes of medical discussion. When using total time on the date of the encounter for code selection, 40 minutes must be met or exceeded. (For services 55 minutes or longer, use prolonged services code 99417)); CPT code 9X091 ( Brief communication technology-based service (e.g., virtual check-in) by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related evaluation and management service provided within the previous 7 days nor leading to an evaluation and management service or procedure within the next 24 hours or soonest available appointment, 5-10 minutes of medical discussion)).

In April 2023, the AMA-RUC noted that the survey instrument they used to develop valuation recommendations for the telemedicine E/M codes did not include the time (when time is used for code selection) in the new telemedicine E/M services descriptors, or the E/M services displayed on the reference service list. The AMA-RUC made interim valuation recommendations and conducted a new survey for September 2023, which included the minimum required times in the code descriptors, and those minimum times were the same as appear in existing O/O E/M services code descriptors (CPT codes 99202-99205, 99212-99215); the new survey in September 2023 included code descriptors and times approved by the CPT Editorial Panel in May 2023. Also, additional specialties who perform E/M services participated in the second round of this survey. For CY 2025, the RUC recommended the following work RVUs: a work RVU of 0.93 for CPT code 9X075, a work RVU of 1.6 for CPT code 9X076, a work RVU of 2.6 for CPT code 9X077, a work RVU of 3.50 for CPT code 9X078, a work RVU of 0.70 for CPT code 9X079, a work RVU of 1.30 for CPT code 9X080, a work RVU of 1.92 for CPT code 9X081, a work RVU of 2.60 for CPT code 9X082, a work RVU of 0.90 for CPT code 9X083, a work RVU of 1.60 for CPT code 9X084, a work RVU of 2.42 for CPT code 9X085, a work RVU of 3.20 for CPT code 9X086, a work RVU of 0.65. for CPT code 9X087, a work RVU of 1.20 for CPT code 9X088.

In April 2023, the AMA-RUC Practice Expense Subcommittee approved the direct practice expense inputs as recommended by the specialty societies without modification, and CMS received these inputs as recommendations from the RUC. The specialty societies detailed their methodology for making some changes to specific clinical activity codes to adapt those clinical activity codes for telemedicine. The AMA edited both CA009 and CA013. The AMA revision to CA009 deletes, “ greet patient, provide gowning ”; the AMA revision to CA013 deletes, “Prepare room, equipment and supplies”. CA009 now reads, “ Ensure appropriate medical records are available ” and CA013 now reads, “ Prepare patient for the visit (i.e., check audio and/or visual ”. The RUC, using the Practice Expense subcommittee recommendations, also recommended to CMS that a camera and microphone “should be considered typical in the computer contained in the indirect overhead expense.” This determination is consistent with CMS' longstanding position that items that are not specifically attributable to the individual services should not be included for valuation of specific codes.

The AMA-RUC recommended the direct practice expense inputs as submitted by the AMA-member specialty societies, and as affirmed by the AMA-RUC Practice Expense Subcommittee. All supply and equipment costs were zeroed out from the reference services, and as a result, the new telemedicine E/M codes did not include any supply or equipment costs in the recommended direct practice expense inputs that the AMA submitted to CMS. The direct PE inputs removed from the reference services to create the new telemedicine E/M codes are: CA010 (obtain vital signs), CA024 (clean room/equipment by clinical staff), SA047 (pack, EM visit), SM022 sanitizing cloth-wipe (surface, instruments, equipment), EQ189 (otoscope-ophthalmoscope [wall unit]), EF048 (Portable stand-on scale), and EF023 (table, exam).

Sixteen of the telemedicine E/M codes describe use of either audio-video or audio-only telecommunications technology to furnish the individual service. The CPT Editorial Panel finalized eight codes for synchronous audio-video services (CPT codes 9X075 to 9X082), and eight codes for synchronous audio-only services (CPT codes 9X083 to 9X0890), and one code for an asynchronous service (CPT code 9X091). The audio-video and audio-only code family subsets have parallel codes for new patients and established patients. Like other E/M codes, these codes may be reported based on the level of medical decision making (MDM) or total time on the date of the encounter. For each set of four codes, there is a code that may be reported for a straightforward, low, moderate and high level of MDM. Start Printed Page 61652

The CPT Editorial Panel also established new CPT code 9X091 describing a brief virtual check-in encounter that is intended to evaluate the need for a more extensive visit (that is, a visit described by one of the office/outpatient E/M codes). The code descriptor for CPT code 9X091 mirrors existing HCPCS code G2012 ( Brief communication technology-based service, e.g., virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion ) and, per the CPT Editorial Panel materials, is intended to replace that code. As described in CPT Editorial Panel final edits, CPT code 9X091 does not require the use of audio or video technology and is expected to be patient-initiated. Furnishing the complete service described by CPT code 9X091 must involve 5-10 minutes of medical discussion (and the code descriptor does not include MDM as means of code selection). CPT code 9X091 should not be reported if it originates from a related E/M service furnished within the previous 7 days, or, if the clinical interaction leads to another E/M or procedure within the next 24 hours or the soonest available appointment. The final CPT Editorial Panel draft language explains that if the virtual check-in described by CPT 9X091 leads to an E/M visit in the next 24 hours, and if that E/M is reported based on time, then the time from the virtual check-in may be added to the time of the resulting E/M visit to determine the total time on the date of encounter for the resulting E/M. The RUC recommended a work RVU of 0.30 for 9X091.

The CPT Editorial Panel also deleted three codes (99441-99443) for reporting telephone E/M services. We note that CPT codes 99441, 99442, and 99443, each are assigned provisional status on the Medicare telehealth services list, and would return to bundled status when the telehealth flexibilities expire on December 31, 2024. For further background, we refer readers to our discussions in previous rulemaking, where CMS explains the rationale for this policy ( 88 FR 78871-78878 ).

CMS has a long-standing interpretation of section 1834(m) of the Act as specifying the circumstances under which Medicare makes payment for services that would otherwise be furnished in person but are instead furnished via telecommunications technology. Specifically, section 1834(m)(2)(A) of the Act expressly requires payment to the distant site physician or practitioner of an amount equal to the amount that such physician or practitioner would have been paid had such service been furnished without the use of a telecommunications system. This means that we must pay an equal amount for a service furnished using a “telecommunications system” as for a service furnished in person (without the use of a telecommunications system). In the CY 2019 PFS final rule, we stated that “[w]e have come to believe that section 1834(m) of the Act does not apply to all kinds of physicians' services whereby a medical professional interacts with a patient via remote communication technology. Instead, we believe that section 1834(m) of the Act applies to a discrete set of physicians' services that ordinarily involve, and are defined, coded, and paid for as if they were furnished during an in-person encounter between a patient and a health care professional” ( 83 FR 59483 ). Under this interpretation, services that are coded and valued based on the understanding that they are not ordinarily furnished in person, such as remote monitoring services and communication technology-based services, are not considered Medicare telehealth services under section 1834(m) of the Act and thus not subject to the geographic, site of service, and practitioner restrictions included therein.

Information provided to CMS from the RUC indicates that CPT codes 9X075-9X090 describe services that would otherwise be furnished in person, and as such the services described by these codes are subject to section 1834(m) of the Act. In the summary of the coding changes, the AMA states that these services are “patterned after the in-person office visit codes.” The draft CPT prefatory language states that “[t]elemedicine services are used in lieu of an in-person service when medically appropriate to address the care of the patient and when the patient and/or family/caregiver agree to this format of care.” The draft CPT prefatory language likewise states that when a telemedicine E/M is billed on the same day as another E/M service “the elements and time of these services are summed and reported in aggregate, ensuring that any overlapping time is only counted once,” which indicates that the work of the telemedicine E/M service is identical to the work associated with an in-person, non-telehealth E/M. The code descriptors and requirements for billing the codes generally mirror the existing office/outpatient E/M codes with the exception of the technological modality used to furnish the service. The audio-video telemedicine E/M codes have nearly identical recommended work RVUs to parallel office/outpatient E/M codes. In general, the audio-only telemedicine E/M codes have lower recommended work RVUs than parallel office/outpatient E/M codes. The RUC stated that this is because, when surveyed, specialty societies indicated that “the audio-video and in-person office visits require more physician work than the audio-only office visits.”

Table 10 describes the similarities between 16 of 17 telemedicine E/M codes and the parallel office/outpatient E/M codes. The table shows that except for the element of “modality” (that is, audio-video or audio-only), the service elements of the new telemedicine E/M code family are no different than the O/O E/M codes (for each enumerated row 1 through 16 the columns display the analogous elements). When comparing code descriptors, as described at the start of this section, the only difference (as represented in Table 10 when comparing the elements of E/M services represented by columns C, D, E, and F) is that these new telemedicine E/M code descriptors lead with the phrase “synchronous audio-video” or “synchronous audio only” before describing the visit in full exactly as the existing office/outpatient E/M visit codes describe a visit in the long descriptor of the analogous service.

There are services already describing audio-video and audio-only telemedicine E/M codes on the Medicare telehealth services list—the office/outpatient E/M code set—that can be furnished via synchronous two-way, audio/video communication technology generally and via audio-only communication technology under certain circumstances to furnish Medicare telehealth services in the patient's home for the purpose of diagnosis and treatment of a mental health disorder or SUD. Additionally, as stated above, section 1834(m)(2)(A) of the Act requires us to pay an equal amount for a service furnished using a “telecommunications system” as for a service furnished in person (without the use of a telecommunications system). Were we to accept the AMA's recommendations and add the telemedicine E/M codes to the Medicare telehealth services list, we would need to establish RVUs for the telemedicine E/M codes to equal the corresponding non-telehealth services to satisfy the requirements for payment under section 1834(m)(2)(A) of the Act.

We do not believe that there is a programmatic need to recognize the audio/video and audio-only telemedicine E/M codes for payment under Medicare. We are proposing to assign CPT codes 9X075-9X090 a Procedure Status indicator of “I”, meaning that there is a more specific code that should be used for purposes of Medicare, which in this case would be the existing office/outpatient E/M codes currently on the Medicare telehealth services list when billed with the appropriate POS code to identify the location of the beneficiary and, when applicable, the appropriate modifier to identify the service as being furnished via audio-only communication technology.

Section 4113 of the Consolidated Appropriations Act (CAA), 2023 extended the availability of Medicare telehealth services to beneficiaries regardless of geographic location or site of service by temporarily removing such statutory restrictions under section 1834(m) of the Act until the end of 2024. Under the current statute, the geographic location and site of service restrictions on Medicare telehealth services will once again take effect for services furnished beginning January 1, 2025. Although there are some important exceptions, including for behavioral health services and ESRD-related clinical assessments, most Start Printed Page 61654 Medicare telehealth services will once again, in general, be available only to beneficiaries in rural areas and only when the patient is located in certain types of medical settings. As previously discussed, the introduction of new CPT coding to describe telemedicine E/M services does not change our authority to pay for visits furnished through interactive communications technology in accordance with section 1834(m) of the Act. We recognize that there are significant concerns about maintaining access to care through the use of Medicare telehealth services with the expiration of the statutory flexibilities that were successively extended by legislation following the PHE for COVID-19. We understand that millions of Medicare beneficiaries have utilized interactive communications technology for visits with practitioners for a broad range of health care needs for almost 5 years. We are seeking comment from interested parties on our understanding of the applicability of section 1834(m) of the Act to the new telemedicine E/M codes, and how we might potentially mitigate negative impact from the expiring telehealth flexibilities, preserve some access, and assess the magnitude of potential reductions in access and utilization. On the latter point, we note that we have developed proposed PFS payment rates for CY 2025, including the statutory budget neutrality adjustment, based on the presumption that changes in telehealth utilization will not affect overall service utilization. We also note that historically we have not considered changes in the Medicare telehealth policies to result in significant impact on utilization such that a budget neutrality adjustment would be warranted. However, we are unsure of the continuing validity of that premise under the current circumstances where patients have grown accustomed over several years to broad access to services via telehealth. We are seeking comment on what impact, if any, the expiration of the current flexibilities would be expected to have on overall service utilization for CY 2025. We refer readers to section IV.B. of this proposed rule for our discussion of budget neutrality adjustments.

Given the similarity between CPT code 9X091 and HCPCS code G2012, we are proposing to accept the RUC-recommended values for CPT code 9X091, and we are proposing to delete HCPCS code G2012. For CPT code 9X091, we propose to accept the RUC- recommended work RVU of 0.30, and are proposing the RUC-recommended direct PE inputs. We note that our proposal does maintain the same direct PE inputs, which the RUC recommendations leave unchanged from the current G2012 in total amount, and allocate the same 3 minutes of time to the same level of staff (Clinical Staff code L037D, RN/LPN/MTA). We believe that the coding and payment recommendations for CPT code 9X091, submitted to CMS by the AMA RUC, accurately reflect the resources associated with this service and believe that maintaining separate coding for purposes of Medicare payment could create confusion. We note that, similar to our current policy for payment of HCPCS code G2012, CPT code 9X091 would be considered a communication technology-based service that is not subject to the requirements in section 1834(m) of the Act applicable to Medicare telehealth services.

In September 2023, the CPT Editorial Panel deleted CPT code 96040 ( Medical genetics and genetic counseling services, each 30 minutes face-to-face with patient/family ) and created CPT code 9X100 ( Medical genetics and genetic counseling services, each 30 minutes of total time provided by the genetic counselor on the date of the encounter ) for medical genetics and genetic counseling services to be provided by the genetic counselor. Prior to its deletion, CPT code 96040 would only be reported by genetic counselors for genetic counseling services, though genetic counselors are not among the practitioners who can bill Medicare directly for their professional services. As we stated in the CY 2012 PFS final rule ( 76 FR 73096 through 73097 ), physicians and NPPs who may independently bill Medicare for their services and who are counseling individuals would generally report office or other outpatient E/M CPT codes for office visits that involve significant counseling, including genetic counseling; therefore CPT code 96040 was considered bundled into O/O E/M visits.

For CPT code 9X100, we are proposing the RUC-recommended direct PE inputs. We note that the code descriptor now specifies that the service is provided by a genetic counselor, therefore we considered assigning Procedure Status “X” to CPT code 9X100. Because the PE RVUs would not display for the code with that assignment and that may impact access to the service with other payors, we are instead proposing bundled status (Procedure Status “B”) for CPT code 9X100 to maintain the status of predecessor CPT code 96040, and we are seeking feedback from interested parties regarding the appropriate procedure status for this code. CPT guidelines for CPT code 9X100 state that a physician or other qualified healthcare professional (QHP) who may report evaluation and management services would not be able to report CPT code 9X100. Instead, these physicians and QHPs would use the appropriate evaluation and management code.

On August 14, 2023, new CPT codes were created to consolidate over 50 previously implemented codes and streamline the reporting of immunizations for the novel coronavirus (SARS-CoV-2, also known as COVID-19). The CPT Editorial Panel approved the addition of a single administration code (CPT code 90480) for administration of new and existing COVID-19 vaccine products. The RUC reviewed the specialty societies' recommendations for this code at the September 2023 RUC meeting.

We are proposing the RUC-recommended work RVU of 0.25 for CPT code 90480 ( Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, single dose ). We are also proposing the RUC-recommended direct PE inputs for CPT code 90480 without refinement.

At the February 2023 CPT Editorial Panel meeting, CPT code 9X059 ( Computerized ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]), posterior segment, with interpretation and report, unilateral or bilateral; retina including OCT angiography ) was created in response to new technology that allows imaging of the retina using optical coherence tomography (OCT) with and without non-dye OCT angiography (OCT-A). This code family also includes CPT code 92132 ( Computerized ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]), anterior segment, with interpretation and report, unilateral or bilateral ), CPT code 92133 ( Computerized ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]), posterior segment, with interpretation and report, unilateral or bilateral; optic nerve ), and CPT code 92134 ( Computerized Start Printed Page 61655 ophthalmic diagnostic imaging (eg, optical coherence tomography [OCT]), posterior segment, with interpretation and report, unilateral or bilateral; retina ). These codes were reviewed at the April 2023 RUC meeting. The RUC determined the survey results were inaccurate due to underestimation of time, so the entire code family was re-surveyed and reviewed at the September 2023 RUC meeting.

We are proposing the RUC-recommended work RVUs for all codes within the Optical Coherence Tomography code family. We are proposing a work RVU of 0.29 for CPT code 92132, a work RVU of 0.31 for CPT code 92133, a work RVU of 0.32 for CPT code 92134, and a work RVU of 0.64 for CPT code 9X059. We are also proposing the RUC-recommended direct PE inputs for all four codes in the family.

The RUC's Relativity Assessment Workgroup (RAW) requested action plans in September 2022 to determine if specific code bundling solutions should occur for CPT codes 93890/93886, 93890/93892, 93892/93886, and 93892/93890. The RAW referred this issue to the CPT Editorial Panel which created three new add-on codes to report when additional studies are performed on the same date of services as a complete transcranial Doppler study. The RUC reviewed these three new add-on codes, as well as CPT codes 93886, 93888, 93892 and 93893 for the September 2023 RUC meeting.

We are proposing the RUC-recommended work RVU for all seven codes in the Transcranial Doppler Studies code family. We are proposing a work RVU of 0.90 for CPT code 93886 ( Transcranial Doppler study of the intracranial arteries; complete study ), a work RVU of 0.73 for CPT code 93888 ( Transcranial Doppler study of the intracranial arteries; limited study ), a work RVU of 1.15 for CPT code 93892 ( Transcranial Doppler study of the intracranial arteries; emboli detection without intravenous microbubble injection ), a work RVU of 1.15 for CPT code 93893 ( Transcranial Doppler study of the intracranial arteries; venous-arterial shunt detection with intravenous microbubble injection ), a work RVU of 0.81 for CPT code 93X94 ( Vasoreactivity study performed with transcranial Doppler study of intracranial arteries, complete ), a work RVU of 0.73 for CPT code 93X95 ( Emboli detection without intravenous microbubble injection performed with transcranial Doppler study of intracranial arteries, complete ), and a work RVU of 0.85 for CPT code 93X96 ( Venous-arterial shunt detection with intravenous microbubble injection performed with transcranial Doppler study of intracranial arteries, complete ). We are also proposing the direct PE inputs as recommended by the RUC for all seven codes in this family.

We note that the billing instructions for this code family specify that the three new add-on codes should be used in conjunction with CPT code 93886, and that CPT code 93888 should not be used in conjunction with CPT codes 93886, 93892, 93893, 93X94, 93X95, and 93X96. However, we believe that it would be beneficial for the CPT Editorial Panel to state more explicitly that CPT code 93X95 should not be used in conjunction with CPT code 93892 and that CPT code 93X96 should not be used in conjunction with CPT code 93893. The work performed in the add-on codes would be duplicative of the base codes in these situations and result in unnecessary overbilling of services.

At the September 2023 CPT meeting, the CPT Editorial Panel created two codes to report passive administration of respiratory syncytial virus, monoclonal antibody, seasonal dose, with and without counseling. CPT codes 96380 and 96381 were reviewed the following week at the September 2023 RUC meeting and the RUC submitted recommendations to CMS.

We are proposing the RUC-recommended work RVU of 0.24 for CPT code 96380 ( Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection, with counseling by physician or other qualified health care professional ) and the RUC-recommended work RVU of 0.17 for CPT code 96381 ( Administration of respiratory syncytial virus, monoclonal antibody, seasonal dose by intramuscular injection ). We understand that these are interim work recommendations from the RUC, and that the RUC intends to conduct a more complete review at a future RUC meeting which we would then consider in future rulemaking. We are also proposing the direct PE inputs as recommended by the RUC for both codes.

In September 2022, the CPT Editorial Panel created two time-based add-on Category I codes, CPT code 96547 ( Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) procedure, including separate incision(s) and closure, when performed; first 60 minutes (List separately in addition to code for primary procedure) ) and CPT code 96548 ( Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) procedure, including separate incision(s) and closure, when performed; each additional 30 minutes (List separately in addition to code for primary procedure) ), to report HIPEC procedures for 2024. At the January 2023 RUC meeting, the RUC reached the conclusion that the survey data was flawed due to a lack of work definition and guidelines, and the RUC recommended contractor pricing for CPT codes 96547 and 96548 for CY 2024 with further clarification from the CPT editorial panel. CMS proposed and finalized contractor pricing for CPT codes 96547 and 96548 for 2024. At the May 2023 CPT Editorial Panel meeting, new guidelines and descriptions of work activities were approved and the codes were resurveyed for the September 2023 RUC meeting with recommendations for national pricing.

We are proposing the RUC-recommended work RVU of 6.53 for CPT code 96547 and the RUC-recommended work RVU of 3.00 for CPT code 96548. The RUC did not recommend, and we are not proposing, any direct PE inputs for the Hyperthermic Intraperitoneal Chemotherapy codes (CPT codes 96547 and 96548).

In April 2022, the RUC referred CPT codes 96920 ( Excimer laser treatment for psoriasis; total area less than 250 sq cm ), 96921 ( Excimer laser treatment for psoriasis; 250 sq cm to 500 sq cm ), and 96922 ( Excimer laser treatment for psoriasis; over 500 sq cm ) to the CPT Editorial Panel to capture expanded indications beyond what was currently noted in the codes' descriptions to include laser treatment for other inflammatory skin disorders such as vitiligo, atopic dermatitis, and alopecia areata, which could result in changed physician work based on the expanded indications. The coding change application was subsequently withdrawn from the September 2023 CPT Editorial meeting when it was determined that existing literature was insufficient and did not support expanded indications at that time. Therefore, these CPT codes were re-surveyed and reviewed at the April Start Printed Page 61656 2023 RUC meeting without any revisions to their code descriptors.

We disagree with the RUC-recommended work RVUs for CPT codes 96920, 96921, and 96922 of 1.00, 1.07, and 1.32, respectively. The RUC noted that there have been multiple reviews of these CPT codes, and the valuation of the codes is currently based on the original valuation over two decades ago in 2002 where the physician time values were lower than the current times. A subsequent review in 2012 adopted new survey times while maintaining the work RVUs from 2002 for CPT codes 96920 and 96922. The RUC noted that, for both CPT code 96920 and 96922 with the largest treatment area, the total times have not changed since first implemented more than 20 years ago. While we understand that the physician times have fluctuated over the course of several years and several reviews, yet the work RVUs have remained mostly constant as shown in Table 11, this was not addressed in the 2012 recommendations, and we believe that our operating assumption regarding the validity of the existing values as a point of comparison is critical to the integrity of the relative value system as currently constructed. The work times currently associated with codes play a very important role in PFS ratesetting, both as points of comparison in establishing work RVUs and in the allocation of indirect PE RVUs by specialty. If we were to operate under the assumption that previously recommended work times had been routinely over or underestimated, this would undermine the relativity of the work RVUs on the PFS in general, in light of the fact that codes are often valued based on comparisons to other codes with similar work times. We also believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs.

For CPT code 96920, we are proposing a work RVU of 0.83 based on a crosswalk to CPT code 11104 ( Punch biopsy of skin (including simple closure, when performed); single lesion ), which has the same 10 minutes of intraservice time and 23 minutes of total time as CPT code 96920. We note that of the 15 other 000-day global codes with a total time of 20 to 25 minutes, only four codes fall above the RUC-recommended work RVU of 1.00. While we understand that commenters will dispute the validity of the current time values, we note that the 2002 intraservice time was 17 minutes, which yields an intraservice time ratio between the 2002 intraservice time and the recommended intraservice time of 10 minutes of 0.68 work RVUs ((10 minutes/17 minutes) * 1.15). We note our proposed work RVU of 0.83 maintains the intensity associated with the 2002 review of CPT code 96920, which we believe to be more appropriate than the significant increase in intensity that results from the RUC-recommended work RVU of 1.00 which nearly doubles the current intensity of the code. We have no evidence to indicate that the intensity of CPT code 96920 is increasing to this degree given how the surveyed work time is substantially decreasing.

For CPT code 96921, we are proposing a work RVU of 0.90 based on a total time ratio to CPT code 96920 ((25/23) * 0.83) and a crosswalk to CPT code 11301 ( Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm ), which has 3 additional minutes of intraservice time and 1 additional minute of total time compared to CPT code 96921. We also note that our proposed work RVU of 0.90 for CPT code 96921 maintains the RUC-recommended incremental difference between CPT codes 96920 and 96921 of 0.07 work RVUs. Like CPT code 96920, we understand that commenters will dispute the validity of the current time values, but we note that the 2002 intraservice time was 20 minutes, which yields an intraservice time ratio between the 2002 intraservice time and the recommended intraservice time of 12 minutes of 0.70 work RVUs ((12 minutes/20 minutes) * 1.17). Like CPT code 96920, we note that proposed work RVU of 0.90 for CPT code 96921 maintains the intensity associated with the 2002 review of CPT code 96921, which we believe is more appropriate than the intensity increase that results from the RUC-recommended work RVU of 1.07 which again nearly doubles the current intensity of the code.

For CPT code 96922, we are proposing a work RVU of 1.15 based on the RUC-recommended incremental difference between CPT codes 96921 and 96922 of 0.25 work RVUs. Like CPT code 96920 and 96921, we understand that commenters will dispute the validity of the current time values, but we note that the 2002 intraservice time was 30 minutes, which yields an intraservice time ratio between the 2002 intraservice time and the recommended intraservice time of 18 minutes of 1.26 work RVUs ((18 minutes/30 minutes) * 2.10). We note that the RUC recommended CPT code 96922 as having the lowest intensity of the three codes in this family and that our proposed work RVU of 1.15 maintains in relationship to the other codes.

For the direct PE inputs, we are proposing to refine the clinical staff Start Printed Page 61657 time for the CA024 activity “Clean room/equipment by clinical staff” to the standard of 3 minutes for CPT codes 96920, 96921, and 96922. We note that 3 minutes is the current CA024 time for these three CPT codes. A rationale for extending clinical staff beyond the standard 3 minutes for the CA024 activity was absent from the PE Summary of Recommendations, therefore we believe the current and standard 3 minutes is more appropriate than the RUC-recommended 5 minutes. We are also proposing equipment times of 36, 38, and 44 minutes for the power table (EF031) and exam light (EQ168) equipment for CPT codes 96920, 96921, and 96922, respectively, to account for the proposed refinement for CA024 to the standard 3 minutes.

We also disagree with the RUC-recommended creation of new supply items for the excimer laser and are proposing to re-include the equipment time for the excimer laser (EQ161) using the current methodology where its cost is accounted for in the equipment of these CPT codes' direct PE. The RUC submitted recommendations to change this equipment item to new supply items to account for the per-use cost to rent the equipment, stating that the business model has changed from the standard equipment ownership that CMS recognizes using standardized equipment formulas to a per-use rental or subscription model. While we understand that there may have been a change in business model, we do not believe a rental, subscription, or per-use fee of an equipment item that is still available to be purchased and is already accounted for with our equipment methodology is appropriate, especially given its implications for direct PE costs for these CPT codes. Therefore, we are proposing reincorporating equipment times of 36, 38, and 44 minutes for the EQ161 equipment for CPT codes 96920, 96921, and 96922, respectively, based on the refined service period clinical labor times. We are proposing to remove the three pay-per-use excimer lasers listed as supplies and recommended by the RUC for these three codes.

We have repeatedly stated in past rulemaking that rental and licensing fees are typically considered forms of indirect PE under our methodology. In the CY 2020 PFS final rule, we omitted the inclusion of several invoices for the monthly rental price of a PET infusion cart (ER109), and only accounted for the four purchase invoices for the equipment. We noted as well for future reference that although we appreciated the submission of the rental invoices, we were unable to use invoices for a monthly rental fee to determine the typical purchase price for equipment. We believe that invoices for a monthly rental fee would not be representative of the purchase price for equipment, in the same fashion that the rental fee for a car differs from its purchase price ( 84 FR 62771 ). Similarly, while we appreciate the submission of per-use, rental, and partnership invoices for the excimer laser, we believe that the excimer laser is appropriately and adequately accounted for in the equipment formula, and note that EQ161 has a very high cost per minute of $0.5895/minute. Compared to the nearly 700 other equipment items in our database, only 55 equipment items have higher costs per minute (based on our standardized formula which accounts for years of useful life, utilization rate, purchase price, and minutes per year of use, discussed in detail in section II.B. of this proposed rule, Determination of PE RVUs) and only 53 equipment items have higher purchase prices than the excimer laser at $151,200. We do not believe that CPT codes 96920 through 96922 should be valued based on a significantly more expensive pay-per-use rental version of the excimer laser when the same treatment is cheaper and available as a purchasable form of equipment.

Therefore, we are seeking comment on the difference in direct PE costs between the purchase and per-use rental of the laser. We note that using the equipment cost per minute formula, discussed in detail of section II.B. of this proposed rule, Determination of PE RVUs, yields direct PE costs of about $21.22, $22.40, and $25.94 for CPT codes 96920, 96921, 96922, respectively. Alternatively, the new supply items for the per-use fee of the laser yielded direct PE costs of $80, $83, and $100 for CPT codes 96920, 96921, 96922, respectively. These direct PE disparities represent a 277 percent, 270.5 percent, and 285.5 percent increase for CPT codes 96920, 96921, 96922, respectively. Given this, we are interested in feedback from interested parties on the payment disparity between this equipment as a per-use or rental versus how we currently account for the purchase of equipment using the standard equipment formula, as we understand that both manufacturers and physicians may be inclined to shift to a per-use or rental business models to limit overhead for purchase and maintenance of expensive equipment.

The RUC's Health Care Professionals Advisory Committee (HCPAC) previously reviewed 19 physical medicine and rehabilitation codes in February 2017. In the CY 2024 PFS proposed rule, CMS received public nominations on these same 19 therapy codes as potentially misvalued ( 88 FR 78851-78852 ). An interested party asserted that the direct PE clinical labor minutes reflected inappropriate multiple procedure payment reductions (MPPR), which were duplicative of the CMS MPPR policy implemented in CMS' claims processing systems. CMS reviewed the clinical labor time entries for these 19 therapy codes and concluded that a payment reduction should not have been applied in some instances to the 19 nominated therapy codes' clinical labor time entries since the payment valuation reduction would be duplicative of the MPPR applied during claims processing. CMS indicated that the valuation of these services would benefit from additional review through the RUC's HCPAC valuation process; they were therefore reviewed by the HCPAC for PE only, with no work review, at the January 2024 RUC meeting for inclusion in the CY 2025 PFS proposed rule.

The HCPAC's direct PE recommendations were based on the typical number of services reported per session, which was 3.5 units according to CMS data, to ensure that there was no duplication in the standard inputs for preservice and postservice time. To account for the MPPR, the HCPAC determined that 3.5 codes are billed per session, with the first paid at 100% and the second and subsequent units paid at half and so forth for PE (for example, 1.00 + 0.5 + 0.5 + 0.25 = 2.25). This resulted in the HCPAC recommending that many of the standard clinical labor times be divided by 2.25 to account for the MPPR, such as taking the standard 3 minutes for greeting and gowning the patient and dividing it by 2.25 to arrive at the recommended time of 1.33 minutes (1.33 + 0.67 + 0.67 + 0.34 = 3 minutes). In most cases, the HCPAC recommended using the standard equipment time formula aside from a few exceptions such as the use of the whirlpool in CPT code 97022 which would require additional time for the cleaning of the equipment. Start Printed Page 61658

Following the January 2024 RUC meeting, representatives from the American Physical Therapy Association (APTA) and the American Occupational Therapy Association (AOTA) met with CMS to express concern with the HCPAC's recommended direct PE inputs for this family of codes. Representatives from these trade associations stated that the HCPAC had inappropriately recommended too few equipment minutes for these procedures. These interested parties requested utilizing an alternate equipment time formula for the 19 reviewed therapy codes based on adding together the intraservice work time together with the clinical labor for the preservice and postservice portion of the service period. For 17 of the 19 reviewed therapy codes, this alternate equipment time formula would result in an increase over the HCPAC's equipment time recommendations. Table 12 lists the direct PE costs of each HCPCS code under their current pricing, under the HCPAC recommendations, and the alternate APTA and AOTA recommendations:

After consideration of these recommendations, we are proposing the direct PE inputs as recommended by the HCPAC for all 19 codes in the Physical Medicine and Rehabilitation code family. We believe that the HCPAC's equipment time recommendations better maintain relativity with the rest of the fee schedule through primarily using standard equipment time formulas, along with limited exceptions for additional equipment time in cases where more time for equipment cleaning or patient positioning would be typical. We also believe that the alternate equipment time formula recommended by APTA and AOTA leads to inconsistent equipment times for many of these procedures, such as recommending 23.98 equipment minutes for CPT code 97110 which is a timed code billed in 15-minute increments. Although we agree that some additional equipment time beyond the timed 15 minutes would be typical for setup and cleaning, 9 additional minutes for each billing of CPT code 97110 would not appear to reflect typical equipment usage.

Given the complexity of determining appropriate direct PE inputs across multiple billings of these therapy codes, and the need to factor in the MPPR, we believe that this code family may benefit from additional review, specifically review focused on the subject of appropriate equipment minutes. The HCPAC review of these codes was primarily focused on the clinical labor portion of the PE inputs and the equipment times did not receive the same degree of scrutiny as the clinical labor. We believe that the HCPAC's recommended direct PE inputs are the most accurate values based on the current information that we have available, however this is a topic that may warrant additional review to ensure that this family of codes is properly valued.

In September 2022, the RUC's Relativity Assessment Workgroup identified the acupuncture codes with 2020 Medicare utilization over 10,000 where the service was surveyed by one specialty but is now performed by a different specialty. CPT codes 97810-97814 were selected and surveyed for the April 2023 RUC meeting.

For CY 2025, we are proposing the RUC-recommended work RVUs for all four CPT codes. We are proposing a work RVU of 0.61 for CPT code 97810 ( Acupuncture, 1 or more needles; without electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient ), a work RVU of 0.46 for CPT code 97811 ( Acupuncture, 1 or more needles; without electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for Start Printed Page 61659 primary procedure) ), a work RVU of 0.74 for CPT Code 97813 ( Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient ), and a work RVU of 0.47 for CPT code 97814 ( Acupuncture, 1 or more needles; with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure) ). We are also proposing the RUC-recommended direct PE inputs for CPT codes 97810, 97811, 97813 and 97814 without refinement.

In April 2022, the Relativity Assessment Workgroup identified services with Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2015 through 2020, including HCPCS codes G0442 ( Annual alcohol misuse screening, 5 to 15 minutes ) and G0443 ( Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes ). In September 2022, the RUC recommended that these services be surveyed for April 2023 after CMS published the revised code descriptor for HCPCS code G0442 in the CY 2023 PFS final rule ( 87 FR 69523 ).

We are proposing the RUC-recommended work RVU of 0.18 for HCPCS code G0442 ( Annual alcohol misuse screening, 5 to 15 minutes ). We are also proposing the RUC-recommended work RVU of 0.60 for HCPCS code G0443 ( Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes ).

The RUC recommended an increase in the work RVU for HCPCS code G0443 from 0.45 to 0.60 which we believe is warranted based on time and intensity of the service in preventing alcohol misuse. In valuing this code, the time and work valuation is for separate and distinct services from same-day E/M services since HCPCS codes G0442 and G0443 are typically billed with an annual wellness visit (AWV) or office visit. We believe that the codes in the adjacent Behavioral Counseling & Therapy family, which includes HCPCS codes G0445 ( High intensity behavioral counseling to prevent sexually transmitted infection; face-to-face, individual, includes: education, skills training and guidance on how to change sexual behavior; performed semi-annually, 30 minutes ), G0446 ( Annual, face-to-face intensive behavioral therapy for cardiovascular disease, individual, 15 minutes), and G0447 ( Face-to-face behavioral counseling for obesity, 15 minutes ), may be undervalued as their respective intensities may be lower than what is warranted for these services. We believe that the intensity for these G-codes may be more in line with the intensity of HCPCS code G0443 which we noted had an increase in intensity as recommended by the RUC. As such, we believe that the Behavioral Counseling & Therapy codes may benefit from additional review in the future to recognize the intensity of these services.

We are proposing to maintain the current 15 minutes of clinical labor time for the CA021 “Perform procedure/service—NOT directly related to physician work time” activity for HCPCS code G0442. This clinical labor activity is specifically noted as not corresponding to the surveyed work time of 5 minutes, and we do not believe that it would be typical for the clinical staff to administer the questionnaire, clarify questions as needed, and record the answers in the patient's electronic medical record in the RUC-recommended 5 minutes. We believe that the current 15 minutes of clinical labor time would be more typical to ensure the accuracy of this screening procedure. We are also proposing to maintain 15 minutes of corresponding equipment time for the EF023 exam table as a result of our proposed clinical labor time refinement. We are proposing the RUC-recommended direct PE inputs for HCPCS code G0443 without refinement.

We thank the RUC for their review of this code family and for highlighting an important consideration specifically for services that fall under the Medicare preventive services benefit. We are now considering how best to implement and maintain payment for preventive services and may develop new payment policies in future rulemaking to address this issue more comprehensively to ensure consistent access to these services. We considered the recommended PE inputs for this code family, as well as for the Annual Depression Screening (HCPCS code G0444) and Behavioral Counseling & Therapy services (HCPCS codes G0445, G0446, and G0447) within this context, as noted below.

In 2012, HCPCS code G0444 ( Annual depression screening, 5 to 15 minutes ) was added to the PFS ( 77 FR 68955 and 68956 ) to report annual depression screening for adults in primary care settings that have staff-assisted depression care supports in place to assure accurate diagnosis, treatment and follow up. In April 2022, the Relativity Assessment Workgroup identified this service with Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2015 through 2020. In September 2022, the RUC recommended that this service be surveyed for April 2023 after CMS published the revised code descriptor in the CY 2023 PFS final rule ( 87 FR 69523 ).

We are proposing the RUC-recommended work RVU of 0.18 for HCPCS code G0444.

We are proposing to maintain the current 15 minutes of clinical labor time for the CA021 “Perform procedure/service—NOT directly related to physician work time” activity for HCPCS code G0444. This clinical labor activity is specifically noted as not corresponding to the surveyed work time of 5 minutes, and we do not believe that it would be typical for the clinical staff to administer the questionnaire, clarify questions as needed, and record the answers in the patient's electronic medical record in the RUC-recommended 5 minutes. We believe that the current 15 minutes of clinical labor time would be more typical to ensure the accuracy of this screening procedure. We are also proposing to maintain 15 minutes of corresponding equipment time for the EF023 exam table as a result of our proposed clinical labor time refinement.

CMS created HCPCS codes G0445 ( High intensity behavioral counseling to prevent sexually transmitted infection; face-to-face, individual, includes education, skills training and guidance on how to change sexual behavior; performed semi-annually, 30 minutes ), G0446 ( Annual, face-to-face intensive behavioral therapy for cardiovascular disease, individual, 15 minutes ), and G0447 ( Face-to-face behavioral counseling for obesity, 15 minutes ) effective with the 2012 Medicare PFS ( 77 FR 68892 ). HCPCS codes G0445-G0447 were identified to be reviewed at the April 2023 RUC meeting because they were services with Medicare utilization of 10,000 or more that had increased by at least 100% from 2015 through 2020.

The specialty societies surveyed HCPCS codes G0445-G0447 for the April 2023 RUC meeting but did not obtain the required number of survey responses. After the resurvey, which occurred after the April 2023 RUC meeting, the specialty societies were again unable to achieve the required minimum number of survey responses Start Printed Page 61660 for any of the codes in this family for the September 2023 RUC meeting. The RUC reviewed HCPCS codes G0445-G0447 at the September 2023 RUC meeting. Given the insufficient number of survey responses and considering that these are CMS-created time-based codes, the RUC determined it would be most appropriate to maintain the current work values and flagged these codes for review in 3 years. We are proposing the RUC-recommended work RVU of 0.45 for each of these three HCPCS codes, G0445-G0447.

We are not proposing the RUC-recommended direct PE inputs for these codes because of the insufficient number of survey responses, and further, we do not agree with some of the RUC's refinements to the direct PE inputs for this service. We are not proposing the RUC-recommended direct PE inputs for G0445, G0446, and G0447, which include the SK062 patient education booklet being eliminated in favor of the SK057 paper, laser printing (each sheet) in the amount of 10 sheets and the equipment minutes being modified to equal the sum of clinical staff time plus the physician/QHP time as reflected by the survey median. We do not agree that these changes are substantiated given the insufficient number of survey responses and we are proposing to maintain the current values for each of these direct PE inputs.

We are proposing the RUC recommended refinements to clinical staff time for HCPCS code G0445. We are proposing to move two minutes from CA021 Perform procedure/service—NOT directly related to physician work time to CA035 Review home care instructions, coordinate visits/prescriptions. We agree with the RUC that this more accurately reflects the clinical work involved in arranging follow-up and/or referrals with clinical and community resources and providing educational materials. Currently, for HCPCS code G0445, PE includes a whip mixer (EP086) and biohazard hood (EP016) among the equipment assigned to the code. We are also proposing the RUC recommendations to eliminate both of these pieces of equipment from the PE for HCPCS code G0445.

We note that the Behavioral Counseling & Therapy code family (HCPCS codes G0445-G0447) should be reviewed in the future by the RUC and we anticipate the recommendations that will come from the review for this family.

HCPCS code G0465 ( Autologous platelet rich plasma (prp) or other blood-derived product for diabetic chronic wounds/ulcers, using an fda-cleared device for this indication, (includes as applicable administration, dressings, phlebotomy, centrifugation or mixing, and all other preparatory procedures, per treatment) ) was created for CY 2022 (retroactively dated back to the effective date of the policy, April 13, 2021) and assigned contractor pricing (NCD 270.3, CR 12403).

Following the publication of the CY 2023 PFS proposed rule, we received two comments on the pricing of HCPCS code G0465, and the 3C patch system supply which is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers, and diabetic ulcers and mechanically or surgically debrided wounds ( 87 FR 69420 ). One commenter submitted invoices associated with the pricing of the 3C patch system (SD343) supply for which we established a price of $625.00 in the CY 2021 PFS final rule ( 85 FR 84498 ). The commenter requested that CMS update its supply database based on invoices submitted for SD343 to reflect an updated price of $750.00 per unit. The commenter also requested national pricing for HCPCS code G0465, expressing concern that insufficient payment disproportionately impacts vulnerable populations. The commenter requested a payment rate of $1,408.90 for HCPCS G0465 in the office setting, stating that this rate would appropriately account for the purchase of the 3C patch, as well as the other related costs and supply inputs required for point of care creation and administration.

In response, we stated in the CY 2023 PFS final rule that we did not have enough information to establish national pricing at this time for HCPCS code G0465 ( 87 FR 69420 ). We stated that we would consider the commenters' feedback for future rulemaking while maintaining contractor pricing for CY 2023, which would allow for more flexibility for contractors to establish appropriate pricing using available information. We appreciated the invoice submission with additional pricing information for the SD343 supply and we updated our supply database for supply code SD343 at a price of $678.57 based on an average of the submitted invoices.

Since the publication of the CY 2023 PFS final rule, interested parties have continued to request national pricing for HCPCS code G0465 due to their perception of inconsistent and insufficient payment for this service by the MACs. CMS has asked the interested parties to engage with the MACs to establish adequate payment for HCPCS code G0465. The interested parties have continued to state that most MACs have not established consistent payment rates and the rates are heterogeneous; some are significantly below the cost of performing this service, leading to an unpredictable process and inadequate rates, creating barriers to access this service.

Due to these concerns, we are therefore proposing to establish national pricing for HCPCS code G0465 for CY 2025. We are proposing to value HCPCS code G0465 using a crosswalk to CPT code 15271 ( Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area ), drawing from a selection of relevant studies. [ 17 18 19 20 ] We are proposing a work RVU of 1.50 for HCPCS code G0465 based on the crosswalk to CPT code 15271 because wound surface area sizes in current literature appear to be less than 100 sq cm for patients with diabetes and/or chronic ulcers. We are also proposing to use the direct PE inputs included with CPT code 15271 for valuing HCPCS code G0465, with the additional inclusion of the 3C patch system (SD343) supply that we priced in CY 2023. We note that the payment includes debridement, which may involve a wound reaching the bone. Therefore, debridement may not be billed separately. In addition, we are currently seeking comments on other available crosswalks from the broader medical community. For example, CPT code 15277 ( Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children ) with a work RVU of 4.00 and CPT code 15273 ( Application of skin substitute graft to Start Printed Page 61661 trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children ) with a work RVU of 3.50 could also be viable crosswalk options. We are soliciting comments regarding our selection of CPT code 15271 as a crosswalk code, as well as general comments and available studies regarding the appropriate valuation of HCPCS code G0465.

In the CY 2024 PFS proposed rule, an interested party nominated two Category III CPT codes, CPT codes 0596T ( Initial insertion of temporary valve-pump in female urethra ) and 0597T ( Replacement of temporary valve-pump in female urethra ), as potentially misvalued. The nominator expressed concern about variability in MAC pricing for the contractor-priced service. Additionally, the nominator highlighted that the payment amounts determined by MACs were inadequately low and did not account for the time and effort required to furnish the services. In their submission, the nominator discussed their anticipated inputs for both codes. For CPT code 0596T, the nominator stated that a physician typically spends 60 minutes inserting the Vesiflo inFlow System. The nominator stated that CPT code 0596T included various supplies, equipment, and clinical labor time totaling $1,902.76, with the inflow supply items making up about 99 percent of the total cost of supplies. For CPT code 0597T, the nominator stated that a physician spends 25 minutes replacing the Vesiflo inFlow System and PE items were similar, with supplies, equipment and clinical labor time costing $505.30, with the inflow supply items making up about 98 percent of the total cost of supplies. We direct interested parties to the CY 2024 PFS final rule ( 88 FR 78850 ) for more detailed submission information regarding CPT codes 0596T and 0597T. After reviewing, we concluded that these codes were not potentially misvalued because they are Category III codes describing relatively new and low-volume services. Category III codes are contractor priced under the PFS, meaning that each MAC can establish pricing for the code within its jurisdiction, resulting in variability in payments.

This year, the nominator newly informed CMS that their analysis of national payment rates showed that in most CMS jurisdictions, not only are these codes misvalued, but in most cases, they are not valued at all, with fee schedule amounts in most CMS jurisdictions at or near zero dollars. The nominator further emphasized that three physician experts, all employed in major university medical centers, have highlighted the challenges posed by the combination of high supply costs and inadequate fee schedule payments, which have hindered their ability to provide services covered by these codes over several years. According to the nominator, these selected physicians also expressed frustration with the reluctance of MACs to address or discuss this issue. Moreover, the nominator highlighted high access barriers as a significant concern. These barriers primarily affect Medicare's most vulnerable beneficiaries, particularly women experiencing permanent urinary retention (PUR), although we note that no quantifiable evidence was provided to support these statements. We acknowledge and appreciate the nominator's efforts in reaching out to experts in the field and patients who rely on these services to elucidate their significant needs.

Since these two Category III CPT codes were not identified as potentially misvalued and were consequently priced by contractors, each MAC can set pricing for the code within its jurisdiction. This could result in inevitable variability in MAC pricings until they receive a higher number of claims, as stated by the nominator. Through our engagement with MACs, we found that claims for the two Category III CPT codes are reviewed on a case-by-case basis for medical necessity. If the claim is payable, the price will be determined at that time by the MAC. Additionally, these codes were a topic of discussion within the MAC pricing workgroup, and we observed that there was not a significant difference among the MACs in terms of allowances based on the proposed pricing methodologies. However, there is variance in how MACs load pricing for Category III codes. For instance, some MACs publish the price for the service before they receive any claims, while others set the price only after they receive claims that help determine the appropriate pricing. If a MAC does not load a price for a code before receiving any claims, the service can still be paid, but the allowance has not been published.

We continue to hear concerns about these payment inconsistencies for CPT codes 0596T and 0597T. As a result, we are recommending that the MACs establish more consistency in pricing, enabling the appropriate inclusion of the Vesiflo system in the code's PE valuation. Therefore, for CY 2025, we encourage interested parties to provide more accurate and appropriate cost data, along with additional information regarding work RVU, work time, indicators, and utilization estimates for the MACs. This should complement the information provided by the nominator in the CY 2024 final rule ( 88 FR 78850 ) and will facilitate the process. To aid in this process, we are adding three new supplies to our direct PE database based on invoices submitted by interested parties: the inFlow Measuring Device at a price of $140 (SD370), the inFlow Valve-Pump Device at a price of $495 (SD371), and the inFlow Activator Kit at a price of $1,250 (SD372). Although we are not proposing national pricing for these two Category III codes, we do note for the benefit of the MACs that CPT code 0596T would typically include one of each of these supplies, whereas CPT code 0597T would typically include only one of the supplies (SD371).

We encourage the MACs to continue to engage with interested parties by providing information on how they price these services. We welcome additional comments from the broader medical community regarding the usage of this service, particularly concerning its safety and effectiveness, as well as potential factors contributing to its low utilization.

Interested parties have expressed concern about the lack of coding and a billing mechanism when practitioners incur costs replacing identified components of the CardioMEMS TM Heart Failure System used in the physician service described by CPT code 33289 ( Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed ).

The CardioMEMS TM Heart Failure System furnished during this service allows practitioners treating heart failure patients to wirelessly monitor and measure pulmonary artery pressure and heart rate in patients with heart failure and transmit the information to the physician to inform the treatment plan for the patient. The system includes two critical components: first, a miniaturized, wireless monitor, which is implanted into a patient's pulmonary artery, and second, a smart pillow (the CardioMEMS TM Patient Electronics System), which captures and transmits Start Printed Page 61662 readings via safe radio frequency from the patient's implanted CardioMEMS TM Heart Failure System. Overall, the CardioMEMS TM Heart Failure System enables patients to transmit critical heart failure status information to clinicians regularly, potentially eliminating the need for frequent clinic or hospital visits.

Interested parties have highlighted the critical importance of the device for heart failure patients who require close monitoring of weight and blood pressure to prevent fluid buildup around the heart, and have requested that CMS establish coding to describe when practitioners incur costs during clinical scenarios when crucial components of the system require replacement. Given that these components are crucial for system functionality and there is no existing coding framework to address their replacement, we believe that establishing appropriate coding and payment mechanisms can facilitate the provision of these services more effectively in the office and hospital settings. Given provided information, we propose assigning contractor pricing to this PE-only code for CY 2025. We are proposing a new code, HCPCS code GMEM1 (Provision of replacement patient electronics system (for example, system pillow) for home pulmonary artery pressure monitoring including provision of materials for use in the home and reporting of test results to physician or qualified health care professional). We are seeking feedback from interested parties on our contractor pricing approach with the aim of establishing national pricing through future rulemaking that can be billed under the OPPS and PFS specifying an ongoing care visit for the CardioMEMS TM Heart Failure System along with the provision of the replacement part. We are specifically looking for information from the broader medical community regarding direct costs from invoices for the replacement component referenced above, utilization estimates, and potential indicators. Additionally, we solicit comments on additional direct PE inputs that we should consider.

Several Portable X-Ray (PXR) suppliers and trade organizations continue to express longstanding concerns with how payment is established for transportation related to these services (HCPCS codes R0070-R0075). CMS has worked with interested parties over the past several years to understand the costs of these services while taking into consideration the MACs perspective on pricing of these costs. Through recent ongoing discussions with interested parties, we learned that interested parties are concerned with the recognition of costs incurred from PXR services and are wanting more consistency in the pricing of these services, including the application of an inflation factor.

We acknowledge the interested parties' concerns and clarify that interested parties may best engage with the MACs through appropriate reporting of cost data in the MAC requested format. This information provided by interested parties can help MACs establish payment rates that are more reflective of costs incurred. MACs are then able to consider this cost information and apply an inflation factor to update changes in costs year over year.

However, CMS recognizes that we should maintain consistency in pricing these services that are more indicative of changes in costs that occur yearly. While still preserving MAC discretion, CMS highlights the usage of an ambulance inflation factor (AIF) that is typically used to adjust ambulance services, which include transportation costs. The AIF is updated annually, and we believe MACs may consider using the AIF to price PXR services when establishing payment rates that are more consistent and reflective of costs incurred.

Additionally, interested parties highlighted inconsistency with language found in our manual and program memoranda policies related to transportation costs. Therefore, to remain consistent and transparent in the pricing of PXR services, we are proposing to revise language in our Medicare Claims Processing manual (Chapter 13, 90.3 and Chapter 23, 30.5) to reflect any updates to our guidance for these services.

CMS received inquiries from several external parties with concerns that MACs have developed local coverage determinations (LCDs) and local coverage articles (LCAs) that down code or restrict payment for complex and non-chemotherapeutic drug administration for CPT code series 96401-96549, when used for the administration of several biologic and infusion drugs, including drugs furnished to treat, for example, rheumatology related conditions.

CMS requested information in the CY 2024 PFS proposed rule ( 88 FR 52837 ) seeking public feedback regarding the concerns of down coding or denials for the administration of non-chemotherapeutic infusion drugs. We received comments that asked for additional clarification from CMS regarding the payment guidelines for the complex non-chemotherapeutic administration code series and updates to the IOM. Commenters urged CMS to provide additional guidance clarifying the conditions under which these complex infusion drugs should be payable.

In response to the comments received, and in response to continuing inquiries on downcoding and or restrictions on payment for non-chemotherapy complex infusion services, we are proposing an updated policy based largely on the IOM Medicare Claims Processing Manual, Chapter 12, section 30.5, to include language currently consistent with CPT code definitions for the complex non-chemotherapy infusion code series stating that the administration of infusion for particular kinds of drugs and biologics can be considered complex and may be appropriately reported using the chemotherapy administration CPT codes 96401-96549. We note that CPT guidance describes requirements for these non-chemotherapy complex drugs or biologic agents to include the need for staff with advanced practice training and competency, such as, a physician or other qualified health care professional to monitor the patient during these infusions due to the incidence of severe adverse reactions. There are also special considerations for preparation, dosage, or disposal for these infusion drugs. These services do involve serious patient risk which requires frequent consults with a physician or other qualified healthcare professional. Based on these facts and comments, we are proposing to update our subregulatory guidance accordingly.

This will also provide complex clinical characteristics for the MACs to consider as criteria when determining payment of claims for these services. The current IOM language does not include the unique characteristics of the administration of these drugs that could provide additional context to the MACs when they are determining appropriate payment. Updating the IOM with the increased detail of these codes would be responsive to the concerns and requests of external parties and will ensure the IOM is consistent with published guidance.

Therefore, we are soliciting and welcome comments on our proposal to revise the IOM to better reflect how complex non-chemotherapeutic drug administration infusion services are furnished and billed. Start Printed Page 61663

Interested parties have continued to engage with CMS and provide recommendations to recognize the increased work associated with diagnosis, management, and treatment of infectious diseases that may not be adequately accounted for in current hospital inpatient or observation E/M codes. Infectious diseases are unique in that they present infection control risks for the patient and close contacts, including healthcare staff, that require attention to safely care for the patient. They present unique challenges in diagnosis in that any previous healthcare interaction could affect the individual resistance patterns of pathogens infecting the individual patient and require close contact with public health agencies since resistance patterns are constantly changing, so a much more extensive medical review is required. Additionally, individual decisions regarding treatment are unique in that use in one patient affects resistance patterns of the entire population, which requires additional expertise to inform antimicrobial selection and management.

We believe that the timing is appropriate for establishing a payment rate for infectious disease physician services since the COVID-19 PHE has ignited a hypervigilance for infectious diseases. Therefore, for CY 2025, we are proposing a new HCPCS code to describe intensity and complexity inherent to hospital inpatient or observation care associated with a confirmed or suspected infectious disease performed by a physician with specialized training in infectious diseases. The full proposed descriptor for the hospital I/O E/M visit complexity add-on code is HCPCS code GIDXX ( Visit complexity inherent to hospital inpatient or observation care associated with a confirmed or suspected infectious disease by an infectious diseases consultant, including disease transmission risk assessment and mitigation, public health investigation, analysis, and testing, and complex antimicrobial therapy counseling and treatment. (add-on code, list separately in addition to hospital inpatient or observation evaluation and management visit, initial, same day discharge, or subsequent ). We anticipate that HCPCS code GIDXX would be reported by physicians with specialized infectious disease training.

We do not believe we should limit the scope of codes with which this proposed add-on HCPCS code could be billed based on visit level; or initial, same day discharge, or subsequent hospital inpatient or observation codes. We are proposing HCPCS code GIDXX as an add-on code (ZZZ global period) separately reportable in addition to CPT codes 99221 ( Initial hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward or low level medical decision making. When using total time on the date of the encounter for code selection, 40 minutes must be met or exceeded. ), 99222 ( Initial hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. When using total time on the date of the encounter for code selection, 55 minutes must be met or exceeded. ), 99223 ( Initial hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. When using total time on the date of the encounter for code selection, 75 minutes must be met or exceeded. ), 99231 ( Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and straightforward or low level of medical decision making. When using total time on the date of the encounter for code selection, 25 minutes must be met or exceeded. ), 99232 ( Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and moderate level of medical decision making. When using total time on the date of the encounter for code selection, 35 minutes must be met or exceeded. ), 99233 ( Subsequent hospital inpatient or observation care, per day, for the evaluation and management of a patient, which requires a medically appropriate history and/or examination and high level of medical decision making. When using total time on the date of the encounter for code selection, 50 minutes must be met or exceeded. ), 99234 ( Hospital inpatient or observation care, for the evaluation and management of a patient including admission and discharge on the same date, which requires a medically appropriate history and/or examination and straightforward or low level of medical decision making. When using total time on the date of the encounter for code selection, 45 minutes must be met or exceeded. ), 99235 ( Hospital inpatient or observation care, for the evaluation and management of a patient including admission and discharge on the same date, which requires a medically appropriate history and/or examination and moderate level of medical decision making. When using total time on the date of the encounter for code selection, 70 minutes must be met or exceeded. ), and 99236 ( Hospital inpatient or observation care, for the evaluation and management of a patient including admission and discharge on the same date, which requires a medically appropriate history and/or examination and high level of medical decision making. When using total time on the date of the encounter for code selection, 85 minutes must be met or exceeded. ). Based on feedback from commenters on the CY 2022 PFS proposed rule comment solicitation regarding infectious diseases ( 86 FR 65125 through 65126 ) and feedback from interested parties, HCPCS code GIDXX would include the following proposed service elements:

Developing, following, and supervising specialized, individualized infection control protocols for an individual patient based on their diagnosis and risks in order to reduce risk of disease transmission.
Coordinating with human resources regarding infection prevention and control measures to enable healthcare facility staff to safely care for patient.
Counseling patients, family members and caregivers regarding infection prevention.
Managing infection prevention and treatment protocols associated with transitions of care for complex patients.
In-depth patient chart review that entails going back farther in time and assessing the complete breadth of all health care interactions, with higher-level synthesis for complex diagnoses.
Communicating with the clinical microbiology lab and directly reviewing specimens.
Coordinating specialized diagnostic evaluations (for example, identifying and facilitating diagnostic laboratory tests only available at specialized laboratories, the state health Start Printed Page 61664 department, and/or the Centers for Disease Control & Prevention).
Coordinating with Federal, State and local public health agencies and laboratories to assist with contact tracing, obtaining specimens for specialized testing, and/or identifying prior testing and treatment for communicable diseases in other jurisdictions.
Counseling patients, family members, and caregivers regarding antimicrobial stewardship and resistance for the patient.
Engaging in complex medical decision-making associated with antimicrobial prescribing including considerations such as antimicrobial resistance patterns, emergence of new variants/strains, recent antibiotic exposure, interactions/complications from comorbidities including concurrent infections, public health considerations to minimize development of antimicrobial resistance, and emerging and re-emerging infections.

For HCPCS code GIDXX, we are proposing a work RVU of 0.89 based on the work RVU for HCPCS code G2211 ( Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established) ), which is 0.33, multiplied by a ratio of the work RVUs for CPT codes 99223 and 99213 ( Office or other outpatient visit for the evaluation and management of an established patient, which requires a medically appropriate history and/or examination and low level of medical decision making. When using total time on the date of the encounter for code selection, 20 minutes must be met or exceeded. ), 3.50 and 1.30, respectively. (This ratio is the work RVU of CPT code 99223 divided by the work RVU of CPT code 99213, 3.50 divided by 1.30, which equals 2.69. Multiplying the 0.33 work RVU of HCPCS code G2211 times 2.69 results in our proposed work RVU of 0.89.) We believe the relationship between the complexity add-on HCPCS code G2211 and a common base code for the add-on code, CPT code 99213, would strike the correct balance to estimate the time and complexity associated with the new HCPCS code GIDXX, compared to what we believe will be a common base code for this new add-on code, CPT code 99223. HCPCS code G2211 has a total time of 11 minutes, therefore, we are proposing a total time of 30 minutes for HCPCS code GIDXX based on the same ratio (11 minutes times the same 2.69 ratio equals 30 minutes). HCPCS code G2211 has no direct PE inputs, and we are proposing the same for HCPCS code GIDXX.

We believe that the proposed work RVU appropriately falls between the following bracket add-on codes: HCPCS code G0316 ( Prolonged hospital inpatient or observation care evaluation and management service(s) beyond the total time for the primary service (when the primary service has been selected using time on the date of the primary service); each additional 15 minutes by the physician or qualified healthcare professional, with or without direct patient contact (list separately in addition to CPT codes 99223, 99233, and 99236 for hospital inpatient or observation care evaluation and management services). (do not report g0316 on the same date of service as other prolonged services for evaluation and management 99358, 99359, 99418, 99415, 99416). (do not report g0316 for any time unit less than 15 minutes) ) with a work RVU of 0.61 and the professional principal care management, chronic care management, and complex chronic care management CPT codes 99425 ( Principal care management services, for a single high-risk disease, with the following required elements: one complex chronic condition expected to last at least 3 months, and that places the patient at significant risk of hospitalization, acute exacerbation/decompensation, functional decline, or death, the condition requires development, monitoring, or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen and/or the management of the condition is unusually complex due to comorbidities, ongoing communication and care coordination between relevant practitioners furnishing care; each additional 30 minutes provided personally by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure) ), 99437 ( Chronic care management services with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored; each additional 30 minutes by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure) ), and 99489 ( Complex chronic care management services with the following required elements: multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, comprehensive care plan established, implemented, revised, or monitored, moderate or high complexity medical decision making; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure) ) with work RVUs of 1.00.

To help inform whether our proposed descriptor is appropriate and reflects the typical service, we are seeking comment on the typical amount of time infectious disease physicians spend on the proposed service elements and the relative intensity compared to similar service elements of other CPT codes. We note that the valuation of HCPCS code GIDXX is meant to capture the visit complexity inherent to hospital inpatient or observation care associated with a confirmed or suspected infectious disease by an infectious diseases consultant that is not accounted for in the appropriate hospital inpatient or observation E/M base code billed by the infectious disease physician.

Interested parties have stated that consultations are a common E/M service performed by infectious disease clinicians, particularly in the inpatient setting, but stated that these services are no longer recognized by Medicare. Interested parties have also stated that this has resulted in a significant reduction in reporting and payment for infectious disease physician services. We note that we address this in the CMS Claims Processing Manual, Chapter 12, section 30.6.9 F, stating that “Physicians may bill initial hospital care service codes (99221-99223), for services that were reported with CPT consultation codes (99241-99255) prior to January 1, 2010, when the furnished service and documentation meet the minimum key component work and/or medical necessity requirements. Physicians may report a subsequent hospital care CPT code for services that were reported as CPT consultation codes (99241-99255) Start Printed Page 61665 prior to January 1, 2010, where the medical record appropriately demonstrates that the work and medical necessity requirements are met for reporting a subsequent hospital care code (under the level selected), even though the reported code is for the provider's first E/M service to the inpatient during the hospital stay.” Accordingly, we are seeking comment on any potential barriers for infectious disease physicians to use the initial and subsequent day hospital inpatient or observation codes, CPT codes 99221 through 99223 and 99231 through 99233, for consultations if they meet the coding requirements for time and/or medical decision making (MDM). We note that understanding the barriers to utilizing these codes is important, as these codes will serve as the base codes for HCPCS code GIDXX, and will need to be billed by the infectious disease physician prior to billing HCPCS code GIDXX.

Finally, we recognize that historically, the CPT Editorial Panel has frequently created CPT codes describing services that we originally established using G codes and adopted them through the CPT Editorial Panel process. We note that we would consider using any newly available CPT coding to describe services similar to those described here in future rulemaking.

To facilitate prompt beneficiary access to PrEP for CY 2024, we established 3 HCPCS G codes that describe the service of counseling and administration of Human Immunodeficiency Virus (HIV) pre-exposure prophylaxis drugs. Specifically, HCPCS codes G0011 ( Individual counseling for pre-exposure prophylaxis (PrEP) by physician or QHP to prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence, 15-30 minutes ) and G0013 ( Individual counseling for pre-exposure prophylaxis (PrEP) by clinical staff to prevent human immunodeficiency virus (HIV), includes: HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence ) describe the counseling portion of the service, and G0012 ( Injection of pre-exposure prophylaxis (PrEP) drug for HIV prevention, under skin or into muscle ) describes the injection of the medication.

CMS released a Proposed NCD for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention on July 12, 2023. This proposed NCD announced CMS' intent to cover and pay for those drugs under the 1861(ddd) additional preventive services authority, and a final decision on the NCD is forthcoming. For CY 2025, we are proposing national rates for these HCPCS codes that reflect the relative resource costs associated with the counseling and drug administration portions of the service, pending finalization of the NCD. For HCPCS code G0011, we are proposing a work RVU of 0.45 based off work and direct PE inputs crosswalked from HCPCS code G0445 ( High intensity behavioral counseling to prevent sexually transmitted infection; face-to-face, individual, includes: education, skills training and guidance on how to change sexual behavior; performed semi-annually, 30 minutes ). For HCPCS code G0012, we are proposing a work RVU of 0.17 based on the work and direct PE crosswalked from CPT code 96372 ( Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular ), and for HCPCS code G0013 we are proposing a work RVU of 0.18 based on the work and direct PE inputs crosswalked from CPT code 99211 ( Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional ). We appreciate having this opportunity for interested parties to provide feedback on the most accurate way to value these services.

For CY 2024, to facilitate beneficiary access to treatment of late-onset Pompe disease with miglustat in combination with cipaglucosidae alfa-atga, we created a new HCPCS code, G0138, describing the service of administration of cipaglucosidase alfa-atga (Pombiliti), which includes the intravenous administration of cipaglucosidase alfa-atga, the provider or supplier's acquisition cost of miglustat, clinical supervision, and oral administration of miglustat. HCPCS code G0138 ( Intravenous infusion of cipaglucosidase alfaatga, including provider/supplier acquisition and clinical supervision of oral administration of miglustat in preparation of receipt of cipaglucosidase alfa-atga ) was added to the PFS effective April 1, 2024, as a contractor priced service. More information regarding the creation of HCPCS code G0138 can be found at https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-4-2023-drugs-and-biologicals-updated-1/30/2024.pdf .

For CY 2025, we are proposing national pricing for this service that reflects the relative resource costs associated with the infusion administration of Cipaglucosidae alfa-atga and clinical supervision and provision of Miglustat oral with acquisition costs. We are proposing a work RVU of 0.21 for HCPCS code G0138 based on a crosswalk from CPT code 96365 ( Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour ). This includes a crosswalked total time of 9 minutes and an intraservice time of 5 minutes. We are also proposing to crosswalk the direct PE inputs from CPT code 96365 for use in valuing HCPCS code G0138. However, we are adding 1 minute of L056A clinical staff time during the preservice portion of the service period to capture the RN/OCN observation of the patient during administration of the Opfolda pill. In addition, to account for the cost of the provision of the self-administered Opfolda as a direct PE input, we are incorporating the wholesale acquisition cost (WAC) data from the most recent available quarter. We are proposing a price of $32.50 for the supply input that describes a 65mg capsule of Opfolda (supply code SH111). We are seeking feedback from interested parties on our proposal of national pricing, as well as our proposed work RVU and direct PE inputs for HCPCS code G0138 to ensure proper payment for this service.

In the CY 2017 PFS final rule ( 81 FR 80330 through 80331 ), we finalized payment for new CPT code(s) describing administration of a patient-focused health risk assessment instrument as well as administration of a caregiver-focused health risk assessment instrument. In the CY 2024 PFS final rule ( 88 FR 78914 ), we finalized the assignment of a payable status for caregiver training services (CTS) for therapy and behavior management/modification services (without the patient present) and finalized the RUC-recommended valuations for these services to better recognize the role that caregivers play in reasonable and necessary care for Medicare beneficiaries. These codes allow treating practitioners to report the training furnished to a caregiver, in tandem with the diagnostic and treatment services furnished directly to the patient, in Start Printed Page 61666 strategies and specific activities to assist the patient in carrying out the treatment plan.

We finalized in the CY 2024 PFS final rule that payment may be made for CTS services when the treating practitioner identifies a need to involve and train one or more caregivers to assist the patient in carrying out a patient-centered treatment plan. We also finalized that because CTS services are furnished outside the patient's presence, the treating practitioner must obtain the patient's (or representative's) consent for the caregiver to receive the CTS. Additionally, we finalized that the identified need for CTS and the patient's (or representative's) consent for one or more specific caregivers to receive CTS must be documented in the patient's medical record. These finalized policies apply to current CTS coding and we are also proposing for them to apply to the newly proposed CTS coding that follows. We continue to receive questions and requests from interested parties about how we can refine payment for these services.

In response to interested parties' requests for assessment of a caregiver's knowledge to be included in caregiver training, we are clarifying that when reasonable and necessary, assessing the caregiver's skills and knowledge for the purposes of caregiver training services could be included in the service described by CPT code 96161 (Administration of caregiver-focused health risk assessment instrument (e.g., depression inventory) for the benefit of the patient, with scoring and documentation, per standardized instrument) to determine if caregiver training services are needed. We also note that CPT code 96161 is currently on the Medicare Telehealth list.

We note that, as specified in the CY 2017 PFS final rule ( 81 FR 80330 ), in particular cases, caregiver-focused health risk assessments can be necessary components of services furnished to Medicare beneficiaries. Examples where this service may be reasonable and necessary may include assessment of maternal depression in the active care of infants, assessment of parental mental health as part of evaluating a child's functioning, assessment of caretaker conditions as indicated where atypical parent/child interactions are observed during care, and assessment of caregivers as part of care management for adults whose physical or cognitive status renders them incapable of independent living and dependent on another adult caregiver. Commenters cited that some examples of such individuals might include intellectually disabled adults, seriously disabled military veterans, and adults with significant musculoskeletal or central nervous system impairments ( 81 FR 80331 ).

We are proposing that because the caregiver-focused health risk assessment may be furnished outside the patient's presence, the treating practitioner must obtain the patient's (or representative's) consent for the caregiver to receive the assessment. We are also proposing that the definition of “caregiver” specified in the CY 2024 PFS final rule ( 88 FR 78917 ) will be the same for caregiver training services and the caregiver-focused health risk assessment.

We are seeking comment on these proposals and clarifications.

We are proposing to establish new coding and payment for caregiver training for direct care services and supports. The topics of training could include, but would not be limited to, techniques to prevent decubitus ulcer formation, wound dressing changes, and infection control. Unlike other caregiver training codes that are currently paid under the PFS, the caregiver training codes for direct care services and support focus on specific clinical skills aimed at the caregiver effectuating hands-on treatment, reducing complications, and monitoring the patient. For example, in the direct care CTS codes, a caregiver could be taught how to properly change wound dressings to promote healing and prevent infection. This skill, among other direct care services, would not fall into the categories of CTS codes that currently exist (behavior management/modification or strategies and techniques to facilitate the patient's functional performance in the home or community) but is integral in effectuating the patient's treatment plan. Like other codes describing caregiver training services, these proposed new codes would reflect the training furnished to a caregiver, in tandem with the diagnostic and treatment services furnished directly to the patient, in strategies and specific activities to assist the patient to carry out the treatment plan. We believe that CTS may be reasonable and necessary when they are integral to a patient's overall treatment and furnished after the treatment plan is established. The CTS themselves need to be congruent with the treatment plan and designed to effectuate the desired patient outcomes. We believe this is especially the case in medical treatment scenarios where assistance by the caregiver receiving the CTS is necessary to ensure a successful treatment outcome for the patient—for example, when the patient cannot follow through with the treatment plan for themselves.

We are proposing three new HCPCS codes: GCTD1 ( Caregiver training in direct care strategies and techniques to support care for patients with an ongoing condition or illness and to reduce complications (including, but not limited to, techniques to prevent decubitus ulcer formation, wound dressing changes, and infection control) (without the patient present), face-to-face; initial 30 minutes ), GCTD2 ( Caregiver training in direct care strategies and techniques to support care for patients with an ongoing condition or illness and to reduce complications (including, but not limited to, techniques to prevent decubitus ulcer formation, wound dressing changes, and infection control) (without the patient present), face-to-face; each additional 15 minutes (List separately in addition to code for primary service) (Use GCTD2 in conjunction with GCTD1) ), and GCTD3 ( Group caregiver training in direct care strategies and techniques to support care for patients with an ongoing condition or illness and to reduce complications (including, but not limited to, techniques to prevent decubitus ulcer formation, wound dressing changes, and infection control) (without the patient present), face-to-face with multiple sets of caregivers) ).

We continue to believe that CTS may be reasonable and necessary when they are integral to a patient's overall treatment and furnished after the treatment plan is established. The medical or direct care CTS themselves need to be congruent with the treatment plan and designed to effectuate the desired patient outcomes. We believe this is especially the case in medical treatment scenarios where assistance by the caregiver receiving the CTS is necessary to ensure a successful treatment outcome for the patient—for example when the patient cannot follow through with the treatment plan for themselves. Direct care training for caregivers of Medicare beneficiaries should be directly relevant to the person-centered treatment plan for the patient in order for the services to be considered reasonable and necessary under the Medicare program. Each training activity should be clearly identified and documented in the treatment plan. Additionally, this would not be billable for patients under home Start Printed Page 61667 health plan of care, receiving at-home therapy, or receiving DME services for involved medical equipment and supplies.

We are seeking additional information from commenters about potential service overlaps and potential examples of direct care services to receive caregiver training to inform our final policy. We are soliciting public comment on each of our proposals for direct care CTS.

For GCTM1, we propose a direct crosswalk to CPT Code 97550 ( Caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (e.g., activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem-solving, safety practices) (without the patient present), face to face; initial 30 minutes ), with a work RVU of 1.00 as we believe this service reflects the resource costs associated when the billing practitioner performs HCPCS code GCTM1. CPT code 97550 has an intraservice time of 30 minutes, and the physician work is of similar intensity to our proposed HCPCS code GCTM1. Therefore, we are proposing a work time of 30 minutes intraservice time (40 minutes of total time) for HCPCS code GCTM1 based on this same crosswalk to CPT 97550. We are also proposing to use this crosswalk to establish the direct PE inputs for HCPCS code GCTM1.

For GCTM2, we are proposing a direct crosswalk to CPT Code 97551 ( Caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (e.g., activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety practices) (without the patient present), face to face; each additional 15 minutes (List separately in addition to code for primary service) ), with a work RVU of 0.54 as we believe this service reflects the resource costs associated when the billing practitioner performs HCPCS code GCTM2. CPT code 97551 has an intraservice time of 17 minutes, and the physician work is of similar intensity to our proposed HCPCS code GCTM2. Therefore, we are proposing a work time of 17 minutes for HCPCS code GCTM2 based on this same crosswalk to CPT 97551. We also propose to use this crosswalk to establish the direct PE inputs for HCPCS code GCTM2.

For GCTM3, we propose a direct crosswalk to CPT Code 97552 ( Group caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (e.g., activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety practices) (without the patient present), face to face with multiple sets of caregivers ), with a work RVU of 0.23 as we believe this service reflects the resource costs associated when the billing practitioner performs HCPCS code GCTM3. CPT code 97552 has an intraservice time of 9 minutes, and the physician work is of similar intensity to our proposed HCPCS code GCTM1. Therefore, we are proposing a work time of 9 minutes intraservice time (14 minutes total time) for HCPCS code GCTM3 based on this same crosswalk to CPT 97552. We are also proposing to use this crosswalk to establish the direct PE inputs for HCPCS code GCTM3.

We are seeking comment on supplies/equipment that would be typical for the newly created direct care strategies and techniques CTS codes.

We believe these services would largely involve contact between the billing practitioner and the caregiver through in-person interactions, which could be conducted via telecommunications, as appropriate. Therefore, we are proposing to add these codes to the Medicare Telehealth Services List to accommodate a scenario in which the practitioner completes the caregiver training service via telehealth. Please see section II.D. for more information on Medicare Telehealth Services.

We are seeking comments on these proposals.

We are proposing to establish new coding and payment for caregiver behavior management and modification training that could be furnished to the caregiver(s) of an individual patient. Current CPT coding (CPT 96202 and 96203) allows for “multiple-family group behavior management/modification training services,” meaning that this caregiver training service can only be furnished in a group setting with multiple sets of caregivers of multiple beneficiaries (please reference 88 FR 78818 for discussion of CPT 96202 and 96203). We are proposing two new HCPCS codes: GCTB1 ( Caregiver training in behavior management/modification for caregiver(s) of a patient with a mental or physical health diagnosis, administered by physician or other qualified health care professional (without the patient present), face-to-face; initial 30 minutes ) and GCTB2 ( Caregiver training in behavior management/modification for caregiver(s) of a patient with a mental or physical health diagnosis, administered by physician or other qualified health care professional (without the patient present), face-to-face; each additional 15 minutes (List separately in addition to code for primary service) (Use GCTB2 in conjunction with GCTB1) ).

We continue to believe that CTS may be reasonable and necessary when they are integral to a patient's overall treatment and furnished after the treatment plan is established. The behavior management/modification CTS themselves need to be congruent with the treatment plan and designed to effectuate the desired patient outcomes. We believe this is especially the case in medical treatment scenarios where assistance by the caregiver receiving the CTS is necessary to ensure a successful treatment outcome for the patient—for example when the patient cannot follow through with the treatment plan for themselves. Behavior management/modification training for caregivers of Medicare beneficiaries should be directly relevant to the person-centered treatment plan for the patient in order for the services to be considered reasonable and necessary under the Medicare program. Each training activity should be clearly identified and documented in the treatment plan. All other policies and procedures surrounding CPT 96202 and 96203 will also apply to these services ( 88 FR 78914-78920 ).

We are seeking comment on these proposals.

For GCTB1, we propose a direct crosswalk to CPT Code 97550 ( Caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (e.g., activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety practices) (without the patient present), face to face; initial 30 minutes ), with a work RVU of 1.00 as we believe this service reflects the resource costs associated when the billing practitioner performs HCPCS code GCTB1. CPT code 97550 has an intraservice time of 30 minutes, and the physician work is of similar intensity to our proposed HCPCS code GCTB1. Therefore, we are proposing a work time of 30 minutes Start Printed Page 61668 intraservice time (40 minutes of total time) for HCPCS code GCTB1 based on this same crosswalk to CPT 97550. We also propose to use this crosswalk to establish the direct PE inputs for HCPCS code GCTB1. We are seeking comment on supplies/equipment that would be typical for the newly created individual behavior management/modification CTS codes.

For GCTB2, we propose a direct crosswalk to CPT Code 97551 ( Caregiver training in strategies and techniques to facilitate the patient's functional performance in the home or community (e.g., activities of daily living [ADLs], instrumental ADLs [iADLs], transfers, mobility, communication, swallowing, feeding, problem solving, safety practices) (without the patient present), face to face; each additional 15 minutes (List separately in addition to code for primary service) ), with a work RVU of 0.54 as we believe this service reflects the resource costs associated when the billing practitioner performs HCPCS code GCTB2. CPT code 97551 has an intraservice time of 17 minutes, and the physician work is of similar intensity to our proposed HCPCS code GCTB2. Therefore, we are proposing a work time of 17 minutes for HCPCS code GCTB2 based on this same crosswalk to CPT 97551. We also propose to use this crosswalk to establish the direct PE inputs for HCPCS code GCTB2.

We are seeking comment on supplies/equipment that would be typical for the newly created individual behavior management/modification CTS codes.

We believe these services would largely involve contact between the billing practitioner and the caregiver through in-person interactions, which could be conducted via telecommunications as appropriate. Therefore, we are proposing to add these codes to the Medicare Telehealth Services List to accommodate a scenario in which the practitioner completes the caregiver training service via telehealth. Please see section II.D. for more information on Medicare Telehealth Services.

In the CY 2024 PFS final rule ( 88 FR 78916 ), we finalized a requirement that the treating practitioner must obtain the patient's (or representative's) consent for the caregiver to receive the CTS and that the identified need for CTS and the patient's (or representative's) consent for one or more specific caregivers to receive CTS be documented in the patient's medical record.

We are proposing that consent for CTS can be provided verbally by the patient (or representative). This would align consent requirements with other services paid under the PFS that may be furnished without the patient present, such as certain care management services. This proposal would apply to CPT codes 97550, 97551, 97552, 96202, and 96203, as well as any caregiver training services HCPCS codes finalized in this year's rule, and any subsequently created caregiver training service codes. We are seeking comment on this proposal.

Please see section II.D. of this proposed rule, Payment for Medicare Telehealth Services, for the discussion related to proposals to add CTS to the Medicare Telehealth list.

(40) Request for Information for Services Addressing Health-Related Social Needs (Community Health Integration (G0019, G0022), Principal Illness Navigation (G0023, G0024), Principal Illness Navigation—Peer Support (G0140, G0146), and Social Determinants of Health Risk Assessment (G0136))

In the CY 2024 PFS final rule ( 88 FR 78920 ), we finalized G-codes to reflect new coding and payment for services describing Community Health Integration (CHI), G0019 (Community health integration services performed by certified or trained auxiliary personnel, including a community health worker, under the direction of a physician or other practitioner; 60 minutes per calendar month), and G0022 (Community health integration services, each additional 30 minutes per calendar month), which may include a community health worker (CHW), incident to the professional services and under the general supervision of the billing practitioner. We finalized a new stand-alone G code describing a SDOH Risk Assessment, G0136 (Administration of a standardized, evidence-based Social Determinants of Health Risk Assessment, 5-15 minutes, not more often than every 6 months). SDOH risk assessment refers to a review of the individual's SDOH or identified social risk factors that influence the diagnosis and treatment of medical conditions. We also finalized PIN services, described by HCPCS code G0023 (Principal Illness Navigation services by certified or trained auxiliary personnel under the direction of a physician or other practitioner, including a patient navigator or certified peer specialist; 60 minutes per calendar month) and G0024 ( Principal Illness Navigation services, additional 30 minutes per calendar month ); G0140 ( Principal Illness Navigation—Peer Support by certified or trained auxiliary personnel under the direction of a physician or other practitioner, including a certified peer specialist; 60 minutes per calendar month ) and G0146 ( Principal Illness Navigation—Peer Support, additional 30 minutes per calendar month ), to better recognize through coding and payment policies when certified or trained auxiliary personnel under the direction of a billing practitioner, which may include a patient navigator or certified peer support specialist, are involved in the patient's health care navigation as part of the treatment plan for a serious, high-risk disease expected to last at least 3 months, that places the patient at significant risk of hospitalization or nursing home placement, acute exacerbation/decompensation, functional decline, or death.

For CY 2025 we are issuing a broad request for information (RFI) on the newly implemented Community Health Integration (CHI) (HPCCS codes G0019, G0022), Principal Illness Navigation (PIN) (HCPCS codes G0023, G0024), Principal Illness Navigation—Peer Support (PIN-PS) (HCPCS codes G0140, G0146), and Social Determinants of Health Risk Assessment (SDOH RA) (HCPCS code G0136) services to engage interested parties on additional policy refinements for CMS to consider in future rulemaking.

We are interested in better addressing the social needs of beneficiaries and requesting information on the codes we created and finalized beginning in CY 2024 to fully encompass what interested parties and commenters believe should be included in the coding and payment we recently established. We are seeking comment on any related services that may not be described by the current coding that we finalized in the CY 2024 PFS final rule and that are medically reasonable and necessary “for the diagnosis or treatment of illness or injury” under section 1862(a)(1)(A) of the Act. We believe we can work within the current coding framework and explore additional opportunities to create codes that describe reasonable and necessary services furnished by billing practitioners and the auxiliary personnel under their general supervision. We are interested in feedback regarding any barriers to furnishing the services addressing health-related social needs, and if the Start Printed Page 61669 service described by the codes we established are allowing practitioners to better address unmet social needs that interfere with the practitioners' ability to diagnose and treat the patient. This could include barriers specific to certain populations, including rural and tribal communities, residents of the U.S. Territories, individuals with disabilities, individuals with limited English proficiency, or other populations who experience specific unmet social needs.

In response to the CY 2024 PFS proposed rule, we heard from commenters that CSWs often connect individuals with community-based resources to address unmet social needs that affect the diagnosis and treatment of medical problems. CSWs can bill Medicare directly for services they personally perform for the diagnosis or treatment of mental illness but are not authorized by statute to bill for services that are provided by auxiliary personnel incident to their professional services. Since CHI and PIN codes are typically provided by auxiliary personnel supervised by the billing practitioner, CSWs could serve as the auxiliary personnel. CSWs could not directly bill Medicare for CHI and PIN services if they were provided by auxiliary personnel, as they are not authorized to supervise, bill, and be paid directly by Medicare for services that are provided by auxiliary personnel incident to their professional services. We believe the current CHI and PIN coding accurately captures the services CSWs currently provide, including the work involved in connecting beneficiaries with community-based resources for unmet social needs that affect the diagnosis or treatment of medical problems. As we stated previously in the CY 2024 PFS final rule ( 88 FR 78926 ), “the codes do not limit the types of other health care professionals, such as registered nurses and social workers, that can perform CHI services (and PIN services, as we discuss in the next section) incident to the billing practitioner's professional services, so long as they meet the requirements to provide all elements of the service included in the code, consistent with the definition of auxiliary personnel at § 410.26(a)(1).” We are clarifying that when we refer to “certified or trained auxiliary personnel” in the following codes: G0019, G0022, G0023, G0024, G0140, G0146, this also includes CSWs.

We are requesting information if there are other types of auxiliary personnel, other certifications, and/or training requirements that are not adequately captured in current coding and payment for these services. We are also interested in hearing more about what types of auxiliary personnel are typically furnishing these services, including the certifications and/or licensure that they have. We are also interested in whether there are nuances or considerations that CMS should understand related to auxiliary personnel and training, certifications or licensure barriers or requirements that are specifically experienced by practitioners serving underserved communities. This could include settings such as community mental health centers, community health clinics including FQHCs and RHCs, tribal health centers, migrant farmworker clinics, or facilities located in and serving rural and geographically isolated communities including the U.S. Territories.

As noted in the CY 2023 PFS final rule ( 87 FR 69790 ) and explained in the CY 2023 PFS proposed rule ( 87 FR 46102 ), when we refer to community-based organizations, we mean public or private not-for-profit entities that provide specific services to the community or targeted populations in the community to address the health and social needs of those populations. They may include community-action agencies, housing agencies, area agencies on aging, centers for independent living, aging and disability resource centers or other non-profits that apply for grants or contract with healthcare entities to perform social services. They may receive grants from other agencies in the U.S. Department of Health and Human Services, including Federal grants administered by the Administration for Children and Families (ACF), Administration for Community Living (ACL), the Centers for Disease Control and Prevention (CDC), the Substance Abuse and Mental Health Services Administration (SAMHSA), or State-funded grants to provide social services. We stated that, generally, we believe such organizations know the populations and communities they serve and may have the infrastructure or systems in place to assist practitioners to provide CHI and PIN services. We stated that we understood that many community-based organizations (CBOs) provide social services and do other work that is beyond the scope of CHI and PIN services, but we believed they are well-positioned to develop relationships with practitioners for providing reasonable and necessary CHI and PIN services.

We are interested in hearing more about CBOs and their collaborative relationships with billing practitioners. The new codes for CHI and PIN services recognized CBOs and their role in providing auxiliary personnel under the general supervision of the billing practitioners. We are seeking comment regarding the extent to which practitioners are contracting with CBOs (including current or planned contracting arrangements) for auxiliary personnel purposes, and if there is anything else CMS should do to clarify services where auxiliary personnel can be employed by the CBO, so long as they are under the general supervision of the billing practitioner. Given that the CHI and PIN services may be provided incident to the billing practitioner's professional services, we are also seeking comment on whether the incident to billing construct is appropriate for CBOs to supplement pre-existing staffing arrangements and the CBO/provider interface. We are also seeking comment on CBOs' roles, the extent to which practitioners are contracting with CBOs, incident to billing, and auxiliary personnel employed by CBOs under general supervision of practitioners serving and located in rural, tribal and geographically isolated communities, including the U.S. Territories.

We are also interested in any comments from interested parties across provider types and from practitioners in geographically isolated communities (for example, rural, tribal, and island communities) and otherwise underserved communities about coding Z codes on claims associated with billing for CHI, PIN, and SDOH risk assessment codes. We recognize that when screening for social needs, such needs may be identified and are interested in learning whether practitioners are also capturing unmet social needs on claims using Z codes for social risk factors or in some other way, and any barriers or opportunities to increase coding of Z codes when social risk factors screen positive.

We are seeking comments on ways to identify specific services and to recognize possible barriers to improved access to these kinds of high-value, Start Printed Page 61670 potentially underutilized services by Medicare beneficiaries.

We are seeking public comment to understand more clearly how often evidence-based care for persons with fractures, for example, is not provided and the reasons for this, and how recent or new PFS codes, or their revaluation, might help resolve specific barriers to its provision. The PFS currently includes many codes that pay for various components of care to manage patients with fractures over a course of treatment, such as transitional care management (TCM) and other care management services, evaluation and management visits (including the inherent complexity add-on for office/outpatient visits), principal illness navigation services, community health integration services, and the social determinants of health risk assessment. We refer readers to our recent guidance on these services on the CMS website at https://www.cms.gov/files/document/health-related-social-needs-faq.pdf . Medicare also pays for bone mass measurement/density tests ( MLN006559— https://www.cms.gov/medicare/prevention/prevntiongeninfo/medicare-preventive-services/mps-quickreferencechart-1.html#BONE_MASS , and for outpatient osteoporosis medication under Part D and, in some cases, Part B ( https://www.medicare.gov/coverage/osteoporosis-drugs ). These services can be billed on their own, or in combination, where applicable. We note that in the CY 2020 PFS final rule ( 84 FR 62685 ) and CY 2021 PFS final rule ( 85 FR 84547 ), CMS indicated that TCM may be billed concurrently with other care management codes when relevant, medically necessary, and not duplicative.

We are proposing new coding in other sections of this CY 2025 proposed rule that might be used to bill for managing fractures under a treatment plan, including the global post-operative add-on code, HCPCS code GPOC1, in section II.G.5 of this proposed rule and the advanced primary care management codes in section II.G.2 of this proposed rule. Interested parties have indicated that orthopedic surgeons, skilled nursing facilities (SNFs), and other practitioners and providers may not be providing comprehensive patient centered fracture management care for quality, payment, or administrative reasons, and that there is inadequate “hand-off” when post-discharge fracture care is transferred to practitioners in the community. They indicate a systemic disconnect on which provider and/or specialty is responsible for osteoporosis diagnosis and treatment, and that global surgical periods focus on acute fracture recovery rather than addressing osteoporosis. We are interested in hearing if the proposed global postop add-on code could help resolve these issues.

In the CY 2024 PFS final rule ( 88 FR 78970 through 78982 ), we finalized separate payment for the O/O E/M visit complexity add-on code. The full descriptor for the O/O E/M visit complexity add-on code, HCPCS code G2211, is ( Visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious condition or a complex condition. (Add-on code, list separately in addition to office/outpatient evaluation and management visit, new or established) ).

The O/O E/M visit complexity add-on code “reflects the time, intensity, and PE resources involved when practitioners furnish the kinds of O/O E/M visit services that enable them to build longitudinal relationships with all patients (that is, not only those patients who have a chronic condition or single high-risk disease) and to address the majority of a patient's health care needs with consistency and continuity over longer periods of time.” ( 88 FR 78970 Start Printed Page 61697 through 78971). We explained in the CY 2024 PFS final rule that it is the relationship between the patient and the practitioner that is the determining factor for when the add-on code should be billed. The add-on code captures the inherent complexity of the visit that is derived from the longitudinal nature of the practitioner and patient relationship. The first part of the code descriptor, the “continuing focal point for all needed health care services,” describes a relationship between the patient and the practitioner when the practitioner is the continuing focal point for all health care services that the patient needs. The second part of the add-on code also describes a relationship involving medical services that are part of ongoing care related to a patient's single, serious condition or a complex condition. There is previously unrecognized but important cognitive effort of utilizing the longitudinal relationship in making a diagnosis, developing a treatment plan, and weighing the factors that affect a longitudinal doctor-patient relationship. The practitioner must decide what course of action and choice of words in the visit itself would lead to the best health outcome in the single visit while simultaneously building up an effective, trusting longitudinal relationship with the patient. Weighing these various factors, even for a seemingly simple condition, makes the entire visit inherently complex, which is what this add-on code is intended to capture ( 88 FR 78973 through 78974 ).

We responded to concerns raised by commenters about potential duplicative payment and potential misreporting of the code, noting that when procedures or other services are reported on the same day by the same billing practitioner as a significant, separately identifiable O/O E/M visit (the base codes that the visit complexity add-on code can be billed with), we believed that the services involve resources that are sufficiently distinct from the costs associated with furnishing stand-alone O/O E/M visits to warrant a different payment policy ( 88 FR 78971 ). We finalized our proposal that the O/O E/M visit complexity add-on code is not payable when the O/O E/M visit is reported with CPT Modifier-25, which denotes a significant, separately identifiable O/O E/M visit by the same physician or other qualified health care professional on the same day as a procedure or other service ( 88 FR 78974 ).

Some commenters expressed concern about our proposal to exclude payment for the visit complexity add-on code when the O/O E/M base code is reported with Modifier-25 because some preventive services such as the annual wellness visit (AWV) or a preventive vaccine are often provided on the same day as a separately identifiable O/O E/M visit, appropriately billed with Modifier-25. The commenters were concerned that practitioners might avoid the policy by not providing a preventive service on the same day as another O/O E/M service. We acknowledged that immunizations and AWVs were sometimes furnished on the same day as an O/O E/M visit and that our policy would prevent payment of the add-on code with such office visits billed with Modifier-25 and indicated that we would monitor utilization of the visit complexity add-on code and continue engagement with interested parties as the policy is implemented ( 88 FR 78975 ).

We have begun to monitor utilization of HCPCS code G2211 and are continuing to engage with interested parties. We continue to hear from some practitioners that our non-payment of the O/O E/M visit complexity add-on code when the O/O E/M base code is reported on the same day as a preventive immunization or other Medicare preventive service is disruptive to the way such care is usually furnished and contrary to our policy objective for establishing the add-on payment. An early analysis of practitioner claims from the first few months of 2024 shows relatively few Medicare preventive services being billed on the day preceding or following an O/O E/M visit. We cannot conclude from this analysis that our policy to deny payment of the O/O E/M visit complexity add-on code when the O/O E/M base code is reported on the same day as a preventive immunization or other Medicare preventive service is disruptive to the way such care is usually furnished. However, we do agree with practitioners expressing concerns that the current policy is not well-aligned with our policy objective for establishing the add-on payment.

In response to these concerns, we are proposing to refine our current policy for services furnished beginning in CY 2025. We are proposing to allow payment of the O/O E/M visit complexity add-on code when the O/O E/M base code is reported by the same practitioner on the same day as an AWV, vaccine administration, or any Medicare Part B preventive service furnished in the office or outpatient setting. Allowing payment for the O/O E/M visit complexity add-on code in this scenario as proposed would support our policy aims, which include paying for previously unaccounted resources inherent in the complexity of all longitudinal primary care office visits. In part, the O/O E/M visit complexity add-on code recognizes the inherent costs of building trust in the practitioner-patient relationship. We believe that trust-building in the longitudinal relationship is more significant than ever in making decisions about the administration of immunizations and other Medicare Part B preventive services. We welcome comments on this proposal.

The CMS Center for Medicare and Medicaid Innovation (CMS Innovation Center) tests innovative payment and service delivery models to reduce program expenditures while preserving or enhancing quality of care. CMS Innovation Center models are assessed for their impact on quality of care and expenditures under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) and the scope and duration of the model test may be expanded through rulemaking if expected to either reduce spending without compromising quality of care or enhance quality of care without increasing spending (section 1115A of the Act). After more than a decade of testing over 50 innovative payment and service delivery models, the CMS Innovation Center has enabled broad transformative changes to service delivery and payment in the Medicare, Medicaid, and CHIP programs which inspire additional transformation throughout the health care delivery system. Participants in CMS Innovation Center models have demonstrated improvements in care delivery and patient experience. The CMS Innovation Center undertook a retrospective review and synthesis of select model evaluations where care delivery changes have been observed, and the review indicated demonstrable evidence of enhanced care delivery in several areas, such as care coordination, team-based care, and leveraging data to risk-stratify patients. [ 21 ]

Under the Medicare Physician Fee Schedule (PFS) statute at section 1848 of the Act, we establish payment Start Printed Page 61698 amounts for covered physicians' services, and update our payment policies to address changes, including changes in medical practice. In this proposed rule, we are proposing to incorporate key payment and service delivery elements from CMS Innovation Center models tested and evaluated over the prior decade into permanent coding and payment under the PFS. Specifically, we are proposing to recognize a primary care practice delivery model trend which we will refer to as “advanced primary care” and which we propose to define using the 2021 National Academies of Sciences, Engineering, and Medicine (NASEM) report on Implementing High-Quality Care as: “whole-person, integrated, accessible, and equitable health care by interprofessional teams that are accountable for addressing the majority of an individual's health and wellness needs across settings and through sustained relationships with patients, families, and communities.” [ 22 ] Using this definition, we are proposing to recognize the resources involved in furnishing services using an “advanced primary care” approach to care under the PFS. [ 23 ] Under this approach, the delivery of care is supported by a team-based care structure and involves a restructuring of the primary care team, which includes the billing practitioner and the auxiliary personnel under their general supervision, within practices. This restructuring creates several advantages for patients, and provides more broad accessibility and alternative methods for patients to communicate with their care team/practitioner about their care outside of in-person visits (for example, virtual, asynchronous interactions, such as online chat), which can lead to more timely and efficient identification of, and responses to, health care needs (for example, practitioners can route patients to the optimal clinician and setting—to a synchronous visit, an asynchronous chat, or a direct referral to the optimal site of care). [ 24 ] Practitioners using an advanced primary care delivery model can more easily collaborate across clinical disciplines through remote interprofessional consultations with specialists as well as standardize condition management into evidence-based clinical workflows, which allow for closed-loop follow-up and more real-time management for patients with acute or evolving complex issues. Practitioners can then use synchronous interactions to build rapport with patients and families, partner on complex decisions, and personalize their patients' care plans.

Specifically, we are proposing to adopt coding and payment policies to recognize advanced primary care management (APCM) services for use by practitioners who are providing services under this specific model of advanced primary care, when the practitioner is the continuing focal point for all needed health care services and responsible for all primary care services. This new proposed coding and payment makes use of lessons learned from the CMS Innovation Center's testing of a series of advanced primary care models, such as Comprehensive Primary Care (CPC), [ 25 ] Comprehensive Primary Care Plus (CPC+), [ 26 ] and Primary Care First (PCF) [ 27 28 ] (see discussion in section II.G.2.a.(1) in this proposed rule) to inform the elements upon which the delivery of APCM services under an advanced primary care delivery model depend. As detailed below in sections II.G.2.b. through II.G.2.d., this proposed coding and payment will incorporate elements of several specific, existing care management and communication technology-based services (CTBS) into a bundle of services, that reflects the essential elements of the delivery of advanced primary care, for payment under the PFS starting in 2025.

In the context of the proposal, we are also interested in feedback on other related policies for our consideration in future rulemaking. To gather information from interested parties to inform potential future proposals, we have included an Advanced Primary Care Hybrid Payment Request for Information (RFI) (Advanced Primary Care RFI) in this proposed rule. The Advanced Primary Care RFI seeks feedback on whether and how we should consider additional payment policies that reflect our efforts to recognize the delivery of advanced primary care, including bundling of additional individual services, which may currently be furnished together as primary care services but paid separately. This focused approach to seeking feedback on advanced primary care payment policies is an important step in our ongoing efforts to emphasize accountable care and supports CMS' goal of having 100 percent of Traditional Medicare beneficiaries in accountable care relationships by 2030. [ 29 ]

In addition to recognizing advanced primary care, this proposed rule also recognizes physician and practitioner work that draws from evidence generated by the CMS Innovation Center's Million Hearts® model. [ 30 ] The Million Hearts® model found that quantitative assessment of patients' atherosclerotic cardiovascular disease (ASCVD) risk and providing high-risk beneficiaries with cardiovascular-focused care management services improved quality of care, including mortality. [ 31 ] We discuss a proposal in this section to establish coding and PFS payment for these services based in part on the evidence generated by the Million Hearts® model.

We have been analyzing opportunities to strengthen and invest in primary care in alignment with the goals of the U.S. Department of Health and Human Services (HHS) Initiative to Strengthen Primary Care. [ 32 ] Research has Start Printed Page 61699 demonstrated that greater primary care physician supply is associated with improved population-level mortality and reduced disparities, [ 33 ] and also, that establishing a long-term relationship with a primary care provider leads to reduced emergency department (ED) visits, [ 34 ] improved care coordination, and increased patient satisfaction. [ 35 ] HHS recognizes that effective primary care is essential for improving access to healthcare, for the health and wellbeing of individuals, families, and communities, and for achieving health equity. The first coordinated set of HHS-wide actions to strengthen primary care, as part of the Initiative, is in primary care payment; for example, adjusting payment to ensure it supports delivery of advanced primary care. CMS Innovation Center models, described in section II.G.2.a.(1) in this proposed rule, reflect the ongoing work within HHS and the unified, comprehensive approach to HHS primary care activities that we are accomplishing through our current statutory authorities and funding.

Over the last decade, we have updated PFS payment policies as appropriate, and we remain committed to improving how Medicare payment recognizes the resources involved in furnishing covered services that encompass aspects of advanced primary care furnished by interprofessional care teams and typically concentrating on the delivery of appropriate preventive care to patients and the management of individuals' chronic conditions as they progress over time. As part of the CY 2014 PFS final rule, we reaffirmed our support of primary care and recognized care management as one of the critical components of primary care that contributes to better health outcomes for individuals and reduced expenditure growth, and explained our prioritization of the development and implementation of several initiatives (such as those discussed in section II.G.2.a.(1) in this proposed rule) ( 77 FR 68978 ). Since then, we have implemented coding and payment for many care management services to better recognize the resources involved in furnishing medically necessary care management activities that generally are performed outside the context of a face-to-face, in-person visit—most often by the billing practitioner's clinical staff on behalf of patients with complex health care needs, including transitional care management in the CY 2013 PFS final rule ( 77 FR 68979 ); non-complex and complex chronic care management (CCM) in the CY 2015, 2017, and 2019 PFS final rules ( 78 FR 74414 , 83 FR 58577 , and 81 FR 80244 ); and principal care management (PCM) in the CY 2020 PFS final rule ( 84 FR 62962 ). The CCM and PCM code families now include 5 sets of codes which are reported monthly on a timed basis, each set with a base code of 20 to 60 minutes and an add-on code for each additional 30 minutes. The code sets vary by the degree of complexity of patient conditions (that is, non-complex and complex CCM for multiple chronic conditions or PCM for a single high-risk condition), and whether the number of minutes spent by clinical staff or the physician or non-physician practitioner (NPP) is used to meet time thresholds for billing.

Additionally, we have established coding and payment for certain services where a medical professional evaluates a patient's medical information remotely using communication technology. As discussed in the CY 2019 PFS final rule, this set of services is defined by and inherently involves the use of communications technology, and includes certain remote patient monitoring services, virtual check-in services, remote evaluation of pre-recorded patient information, remote interpretations of diagnostic imaging tests, and interprofessional consultations. We recognize that technological advances have changed and continue to change the practitioner-patient care delivery interaction. We have recognized these technology-enabled interactions through separately billable CTBS over the last several years. However, we acknowledge, as we learn more about how advanced primary care services are furnished to patients, that in some clinical care delivery scenarios, practitioners furnishing the type of care highlighted in this discussion may furnish certain aspects of the CTBS services in complement to care management services (for example, by allowing interprofessional care teams to answer patient questions, refer patients to higher levels of care, view and interpret patient images, order needed treatments, and offer reassurance or advice), in an effort to more efficiently manage the quantity and quality of medical information that is necessary to support effective patient-centered treatment plans.

Despite these important steps to pay separately for these care management services, there has been limited uptake of care management services and Medicare still overwhelmingly pays for primary care through traditional office/outpatient (O/O) Evaluation and Management (E/M) visit codes, which describe a broad range of physicians' services but do not fully distinguish and account for the resources associated with primary care and other longitudinal care. As we stated in the CY 2024 PFS final rule, we believe that because E/M visit codes are intended to be used very broadly, the complexity of services required to provide this type of care is not fully incorporated as part of the valuation of the work RVUs when the E/M code itself is used as the primary way to report the work of the professional ( 88 FR 78972 ). In the CY 2024 PFS final rule, we took steps to better recognize the inherent complexity of visits associated with primary and longitudinal care of patients by finalizing a new add-on code (HCPCS code G2211) for use by practitioners furnishing services as the continuing focal point for all the patient's needed health care services, such as a primary care practitioner ( 88 FR 78969 ). When furnishing primary and longitudinal care, practitioners must be attuned to the factors that develop and maintain trusting practitioner-patient relationships that enable effective diagnosis, management, and treatment on an ongoing basis. In finalizing the O/O E/M visit complexity add-on code, we recognized the feedback from interested parties indicating that the care management codes alone may not have mitigated the deficiencies in the ability of existing E/M codes to reflect the time and resources involved in furnishing visits in the context of longitudinal care—of which, advanced primary care is one model. Many commenters responded, as reflected in the CY 2024 PFS final rule, that they did not view the coding and payment currently available under the PFS as capable of recognizing the broad range of elements that define primary care ( 88 FR 52326 ). Other commenters responded that they did not believe that the existing E/M service codes alone reflect the work and resources involved in furnishing non- Start Printed Page 61700 procedural care to Medicare beneficiaries ( 88 FR 78976 ).

Over the years, interested parties have focused attention on the ongoing need to improve how practitioners are paid, in and outside of payment bundles, including but not limited to the possibility of E/M codes designed specifically to be billed in conjunction with care management codes and the elimination of multiple disparities between the payment for E/M services in global periods and those furnished individually. Based on feedback from the physician and practitioner community, we understand that advanced primary care encompasses the work of interprofessional teams who are accountable for addressing the majority of an individual's health and wellness needs across settings and through sustained relationships, which necessarily involves time spent by primary care practitioners and their clinical staff outside of individual E/M visits.

As with many services paid under the PFS, we balance making payment that recognizes and supports technological developments in healthcare and the resources involved in evolving medical practice to allow for appropriate and expanded access to innovative technologies and newer services with promoting stability and efficiency in coding and billing rules for practitioners and institutions. We recognize the important role of gathering input and information from the CMS Innovation Center models (described in more detail in section II.G.2.a.(1) in this proposed rule), comment solicitations, research from other public and private entities, the work of all parties involved in furnishing primary care, and from the public at large. As previously noted, interested parties have given ample feedback over the years to inform our recognition of care management services; for example, as part of the CY 2022 PFS rulemaking, interested parties specifically requested our consideration of a “30-day global period bundling care management services” and we responded that we would consider this suggestion for future rulemaking ( 86 FR 65118 ). We have continued to incorporate feedback into our rulemaking and strengthen our care management code sets with the goal of better recognizing the elements of advanced primary care as part of a multi-year strategy. Based on this feedback, we are proposing to establish a set of codes to better describe advanced primary care management services broadly, to provide more stability in payment and coding for practitioners in the context of continued evolution in advanced primary care, as well as to provide us with a mechanism for continued and intentional improvements to advanced primary care payment.

We have prioritized the implementation or testing of a series of initiatives designed to improve payment for, and encourage long-term investment in, primary care and care management services. By supporting enhanced care management and coordination, these initiatives contributed to the growing practice of advanced primary care and have also provided valuable lessons learned that we are incorporating into our proposals.

Several CMS Innovation Center models address payment for care management services and CTBS. The CPC initiative, [ 36 ] the CPC+ model, [ 37 ] and the PCF model [ 38 ] all included payments for care management services that closely aligned with the care management services included in the PFS. In these initiatives, primary care practices received risk-adjusted, per beneficiary per month (PBPM) payments for care management services furnished to Medicare FFS beneficiaries attributed to their practices. These model payments were designed to offer practices a stable, predictable revenue stream that supported required infrastructure and appropriately compensated practices for the enhanced services they would provide. Practices participating in CPC+ consistently cited these payments as the most useful type of model payment support they received; these stable, prospectively paid payments typically served as the main funding source for compensating care managers, behavioral health providers, and other staff hired to improve care delivery. [ 39 ] Because these payments were paid prospectively and could be used to support a range of care management and coordination activities, they provided participants with greater financial stability and flexibility to develop and expand capabilities to meet patients' care needs. [ 40 ] Table 19 identifies a number of CMS Innovation Center models and key care delivery methods from each. [ 41 ]

We are proposing to establish coding and make payment under the PFS for a newly defined set of APCM services described and defined by three new HCPCS G-codes. To recognize the resource costs associated with furnishing APCM services to Medicare beneficiaries, we are proposing to establish and pay for three new G-codes that describe a set of care management services and CTBS furnished under a broader application of advanced primary care. This new coding and payment would reflect the recognized effectiveness and growing adoption of the advanced primary care approach to care. [ 42 ] It would also encompass a broader range of services and simplify the billing and documentation requirements, as compared to existing care management and CTBS codes, for clinicians who care for their patients using an advanced primary care model. We recognize that there are primary care physicians, practitioners, and practices beyond those that have participated in CMS Innovation Center primary care models (such as those discussed in section II.G.2.a.(1) in this proposed rule), that may incur resource costs associated with their treatment of patients based on the advanced primary care delivery model. Providing care using an advanced primary care delivery model involves resource costs associated with maintaining certain practice capabilities and continuous readiness and monitoring activities to support a team-based approach to care, where significant resources are used on virtual, asynchronous patient interactions, collaboration across clinical disciplines, and real-time management of patients with acute and complex concerns, that are not fully recognized or paid for by the existing care management codes. We have observed medical practice trends in primary care for several years. We note that in prior rulemaking, for example, in the CY 2013 PFS final rule, we stated, “we further consider[ed] how advanced primary care practices can fit within a fee-for-service model” ( 77 FR 68987 ), and in the CY 2015 PFS final rule, we stated our commitment “to supporting advanced primary care, including the recognition of care management as one of the critical components of primary care that contributes to better health for individuals and reduced expenditure growth” ( 79 FR 67715 ). In the CY 2017 PFS final rule, we discussed changes to retain elements of the CCM service that are “most characteristic of the changes in medical practice toward advanced primary care” ( 81 FR 80251 ). As the delivery of primary care has evolved to embrace advanced primary care more fully, we believe that it is prudent to now adopt specific coding and payment policy to better recognize the resources involved in care management under an advanced primary care delivery model.

Below, we explain the proposed new codes and their descriptors. In the next section, we propose to define the elements of the scope of service for APCM that would be required for a practitioner to bill Medicare for the APCM service, and we explain the proposed standards for practices that furnish APCM services to ensure that the physicians and practitioners who bill for these services have the capability to fully furnish advanced primary care, including APCM services (see section II.G.2.c. of this proposed rule). At this time, we are proposing to identify specific care management and CTBS services that are a part of advanced primary care delivery and would be bundled into the PFS payment for the APCM services. As such, we will identify the services that we are proposing would overlap substantially with the new codes and which would not be separately billable with the APCM codes under our proposal (see section II.G.2.d. of this proposed rule). Finally, we propose to establish relative values for these codes for purposes of payment under the PFS (see section II.G.2.e. of this proposed rule).

We are proposing to establish the following G-codes and descriptors for APCM services, and as explained in the next section, due to the similar scope of APCM and other care management and CTBS services, we are proposing to include some of the same language from the CCM and PCM service elements in the APCM code descriptors, as well as emphasize that certain practice capabilities and requirements are inherent in these elements and must be met in order to bill for APCM services:

HCPCS code GPCM1 ( Advanced primary care management services provided by clinical staff and directed by a physician or other qualified health care professional who is responsible for all primary care and serves as the continuing focal point for all needed health care services, per calendar Start Printed Page 61703 month, with the following elements, as appropriate:

++ Inform the patient of the availability of the service; that only one practitioner can furnish and be paid for the service during a calendar month; of the right to stop the services at any time (effective at the end of the calendar month); and that cost sharing may apply.

++ Document in patient's medical record that consent was obtained.

Initiation during a qualifying visit for new patients or patients not seen within 3 years;
Provide 24/7 access for urgent needs to care team/practitioner, including providing patients/caregivers with a way to contact health care professionals in the practice to discuss urgent needs regardless of the time of day or day of week;
Continuity of care with a designated member of the care team with whom the patient is able to schedule successive routine appointments;
Deliver care in alternative ways to traditional office visits to best meet the patient's needs, such as home visits and/or expanded hours;
Overall comprehensive care management;

++ Systematic needs assessment (medical and psychosocial).

++ System-based approaches to ensure receipt of preventive services.

++ Medication reconciliation, management and oversight of self-management.

Development, implementation, revision, and maintenance of an electronic patient-centered comprehensive care plan;

++ Care plan is available timely within and outside the billing practice as appropriate to individuals involved in the beneficiary's care, can be routinely accessed and updated by care team/practitioner, and copy of care plan to patient/caregiver;

Coordination of care transitions between and among health care providers and settings, including referrals to other clinicians and follow-up after an emergency department visit and discharges from hospitals, skilled nursing facilities or other health care facilities as applicable;

++ Ensure timely exchange of electronic health information with other practitioners and providers to support continuity of care.

++ Ensure timely follow-up communication (direct contact, telephone, electronic) with the patient and/or caregiver after an emergency department visit and discharges from hospitals, skilled nursing facilities, or other health care facilities, within 7 calendar days of discharge, as clinically indicated.

Ongoing communication and coordinating receipt of needed services from practitioners, home- and community-based service providers, community-based social service providers, hospitals, and skilled nursing facilities (or other health care facilities), and document communication regarding the patient's psychosocial strengths and needs, functional deficits, goals, preferences, and desired outcomes, including cultural and linguistic factors, in the patient's medical record;
Enhanced opportunities for the beneficiary and any caregiver to communicate with the care team/practitioner regarding the beneficiary's care through the use of asynchronous non-face-to-face consultation methods other than telephone, such as secure messaging, email, internet, or patient portal, and other communication-technology based services, including remote evaluation of pre-recorded patient information and interprofessional telephone/internet/EHR referral service(s), to maintain ongoing communication with patients, as appropriate;

++ Ensure access to patient-initiated digital communications that require a clinical decision, such as virtual check-ins and digital online assessment and management and E/M visits (or e-visits).

Analyze patient population data to identify gaps in care and offer additional interventions, as appropriate;
Risk stratify the practice population based on defined diagnoses, claims, or other electronic data to identify and target services to patients;
Be assessed through performance measurement of primary care quality, total cost of care, and meaningful use of Certified EHR Technology. ).

HCPCS code GPCM2 ( Advanced primary care management services for a patient with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, which place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, provided by clinical staff and directed by a physician or other qualified health care professional who is responsible for all primary care and serves as the continuing focal point for all needed health care services, per calendar month, with the elements included in GPCM1, as appropriate ) and HCPCS code GPCM3 ( Advanced primary care management services for a patient that is a Qualified Medicare Beneficiary with multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, which place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, provided by clinical staff and directed by a physician or other qualified health care professional who is responsible for all primary care and serves as the continuing focal point for all needed health care services, per calendar month, with the elements included in GPCM1, as appropriate ).

HCPCS codes GPCM1 through GPCM3 would describe APCM services furnished per calendar month, following the initial qualifying visit (see section II.G.2.c.(1) for more on the initiating visit). Physicians and NPPs, including nurse practitioners (NPs), physician assistants (PAs), certified nurse midwives (CNMs) and clinical nurse specialists (CNSs), could bill for APCM services. As we will describe in more detail in section II.G.2.c., within the code descriptors for GPCM1, GPCM2, and GPCM3, we are including the elements of the scope of service for APCM as well as the practice capabilities and requirements that we believe to be inherent to care delivery by the care team/practitioner who is billing under a practice using an advanced primary care delivery model, and necessary to fully furnish and, therefore, bill for APCM services.

As described in more detail below, within the code descriptors for GPCM1, GPCM2, and GPCM3, we are proposing that the practitioner who bills for APCM services intends to be responsible for the patient's primary care and serves as the continuing focal point for all needed health care services. We anticipate that most practitioners furnishing APCM services will be managing all the patient's health care services over the month and have either already been providing ongoing care for the beneficiary or have the intention of being responsible for the patient's primary care and serving as the continuing focal point for all the patient's health care services. We anticipate that these codes will mostly be used by the primary care specialties, such as general medicine, geriatric medicine, family medicine, internal medicine, and pediatrics, but we are also aware that, in some instances, certain specialists function as primary care practitioners—for example, an OB/GYN or a cardiologist. In contrast to situations where the patient's overall, ongoing care is being managed, monitored, and/or observed by a practitioner, we believe that there are situations when care is provided by a practitioner who would not serve as Start Printed Page 61704 “the continuing focal point for all needed health care services.”

Similarly, there are some time- or condition-limited practitioner-patient relationships that are clearly not indicative of the ongoing care that we anticipate practitioners would be responsible for when furnishing APCM services. As we stated in the CY 2021 PFS proposed rule and CY 2024 PFS final rule in the context of our policies for the O/O E/M visit complexity add-on code (HCPCS code G2211), a practitioner whose “relationship with the patient is of a discrete, routine, or time-limited nature; such as, but not limited to, a mole removal or referral to a physician for removal of a mole; for treatment of a simple virus, for counseling related to seasonal allergies, initial onset of gastroesophageal reflux disease; treatment for a fracture; and where comorbidities are either not present or not addressed, and/or when the billing practitioner has not taken responsibility for ongoing medical care for that particular patient with consistency and continuity over time, or does not plan to take responsibility for subsequent, ongoing medical care for that particular patient with consistency and continuity over time” ( 85 FR 84570 and 84571 , 88 FR 78971 ). For example, a patient who spends one month of the year in another location could require physicians' services in that location if they experience exacerbation of one of their chronic conditions, but the practitioner who treats them would not intend to manage or monitor that patient's overall, ongoing care. Finally, HCPCS code G2211 can also be billed when medical services are “part of ongoing care related to a patient's single, serious condition or complex condition,” but this is different from the APCM requirement. A practitioner's management of one or more serious conditions (as is often the case with specialty care), without more, does not mean that the practitioner is also responsible for all primary care services and the focal point for all needed care (the requirement for APCM), and thus would not necessarily mean that the practitioner could bill for APCM.

As is our current policy for other care management services, and consistent with both CPT guidance and Medicare rules for CPT codes 99487, 99489, 99490, we are proposing that HCPCS codes GPCM1, GPCM2, and GPCM3 may only be reported once per service period (calendar month) and only by the single practitioner who assumes the care management role with a particular beneficiary for the service period. That is, based on a patient's status, a physician or practitioner would identify the patient to receive Level 1, Level 2, or Level 3 APCM services during a given service period (calendar month), and we would make payment for only one claim for APCM services for that service period. At this time, we do not see the need or value of proposing restrictions or complex operational mechanisms to identify a single physician or NPP who may bill for APCM services for a specific beneficiary. However, we recognize that other initiatives, such as the Medicare Shared Savings program, have operational mechanisms in place to attribute patients to certain ACOs (§ 425.400). While a similar approach could be used to attribute patients for APCM services, we are reluctant to introduce unnecessary complexity for these services. As we continue to develop our policies in this area, we are seeking feedback from interested parties on methodologies that could allow for identification of the beneficiary's primary care practitioner. We are also seeking comment on whether there should be additional requirements to prevent potential care fragmentation or service duplication.

We anticipate that APCM services would ordinarily be provided by clinical staff incident to the professional services of the billing practitioner in accordance with our regulation at § 410.26. We are proposing that APCM services would be considered a “designated care management service” under § 410.26(b)(5) and, as such, could be provided by auxiliary personnel under the general supervision of the billing practitioner.

Unlike the current coding to describe care management services, we are further proposing that the code descriptors for GPCM1, GPCM2, and GPCM3 would not be time-based. Based on feedback from the physician and practitioner community, we understand that ongoing care management and coordination services are standard parts of advanced primary care, even in months when documented clinical staff or billing professional minutes may not reach the required thresholds for billing or the patient's condition does not meet the clinical conditions for care management services under the existing code set. In consideration of the extensive feedback from interested parties, we have learned that practitioners who currently furnish monthly care management services may already be providing APCM services in a variety of clinical circumstances, documenting all necessary aspects of the patient-centered care furnished monthly to the patient without meeting the requirements to bill for care management services, such as satisfying the administrative requirement to count clinical staff minutes to reach specific time-based thresholds. As we stated in the CY 2024 PFS final rule in the context of the O/O E/M visit complexity add-on code (HCPCS code G2211), primary care physicians may diagnose and treat a condition in an O/O E/M visit that is not expected to last as long as three months or would not reasonably be expected to result in a risk of hospitalization, and the practitioner's clinical staff may provide significant care management and coordination services relating to that condition. For example, COVID-19 cases are clinical circumstances that generally do not last three months but may require significant acute management, care coordination, and follow-up within a given month, particularly for patients with comorbidities ( 88 FR 78973 ). Practitioners may also provide care management and coordination services to a patient whose condition meets the criteria in one or more care management codes, but the documented minutes of service may not reach the minimum time threshold to bill for a care management service. For example, the practitioner might provide care coordination for a month that includes 20 minutes of consulting with the patient's other healthcare providers and modifying medications to address an acute exacerbation of hypertension, but would not meet the requirements for billing the PCM service. We also note that, unlike the current coding to describe certain CTBS services, we are proposing that the code descriptors for GPCM1, GPCM2, and GPCM3 would not include the timeframe restrictions for billing certain CTBS (for example, the restriction for virtual check-in services that there is not a related E/M service provided within the previous 7 days or an E/M service or procedure within the next 24 hours or the soonest available appointment). As addressed in the CY2019 Final Rule, we have heard from interested parties that the timeframe restrictions for billing certain CTBS are administratively burdensome ( 83 FR 59686 ).

We are also proposing that not all elements included in the code descriptors for APCM services must be furnished during any given calendar month for which the service is billed. APCM services are largely designed to be person-centered and focused on the individual patient, such that the elements that are provided depend on medical necessity and individual patient need. Therefore, we anticipate that all the APCM scope of service Start Printed Page 61705 elements (for example, comprehensive care management and care coordination) will be routinely provided, as deemed appropriate for each patient, acknowledging that not all elements may be necessary for every patient during each month (for example, the beneficiary may have no hospital admissions that month, so there is no management of a care transition after hospital discharge). We also anticipate that there may be some months where it may be appropriate for some service elements to be performed more than once for the patient. For example, in one month a patient with heart failure and chronic kidney disease receiving APCM Level 2 services (GPCM2) may be on a stable medication regimen, receive communication about their care plan, but no virtual check-ins. The next month, the patient may experience a heart failure exacerbation requiring inpatient admission, and then receive as part of their APCM service timely communication and follow-up with new labs ordered, multiple virtual check-ins ensuring that the patient understands their new medications, a phone call to help the patient understand the lab results, and an interprofessional consultation with the patient's cardiologist to help decide if the patient's diuretic dosage should be changed.

However, even if not all elements of the APCM service are furnished each month for which APCM is billed, we propose that billing practitioners and auxiliary personnel must have the ability to furnish every service element and furnish these elements as is appropriate for any individual patient during any calendar month. As described in more detail in section II.G.2.c. of this proposed rule, we believe that maintaining certain advanced primary care practice capabilities and requirements is inherent in these elements and must be met to fully furnish and bill APCM. For example, if in our previous example, the patient with heart failure and chronic kidney disease receiving Level 2 APCM experiences swollen legs, the patient should be able to submit a photo or video to the practitioner via a secure communications system, and the practitioner must be able to interpret and communicate remotely with the patient about those images.

While we are proposing that specific minutes spent furnishing APCM services for purposes of billing HCPCS codes GPCM1-GPCM3 need not be documented in the patient's medical record, we would expect that any actions or communications that fall within the APCM elements of service would be described in the medical record and, as appropriate, its relationship to the clinical problem(s) they are intended to resolve and the treatment plan, just as all clinical care is documented in the medical record.

We are seeking feedback on these service descriptions, and on whether there are elements of other care management services that should be removed or altered for purposes of APCM services.

Finally, while the service descriptors above are consistent across all three APCM levels because the scope of service elements are consistent across all levels of APCM and the elements that are provided depend on medical necessity and individual patient need, we are proposing that the APCM codes would be stratified into three levels based on certain patient characteristics that are broadly indicative of patient complexity and the consequent resource intensity involved in the provision of these services in the context of advanced primary care. We are proposing that the new APCM coding schema would be stratified based on APCM services being furnished using the advanced primary care model to patients with one or fewer chronic conditions (“Level 1”); patients with two or more chronic conditions (“Level 2”); and Qualified Medicare Beneficiaries (QMBs) [ 43 ] with two or more chronic conditions (“Level 3”) (see Table 20 for the three APCM code levels). This stratification of APCM into three levels allows us to distinguish among different levels of patient complexity and more accurately reflect the resources required to furnish APCM services for certain categories of beneficiaries. We anticipate that a practitioner using the advanced primary care model would bill for APCM services for all or nearly all the patients for whom they intend to assume responsibility for primary care.

Furthermore, we recognize the ways in which this new APCM coding intersects with current care management codes around number of chronic conditions. We note that the current care management codes are generally stratified in a similar, though more granular way, by the degree of complexity of care based on the presence of chronic conditions and complexity of medical decision making, who directly performs the service, and the time spent furnishing the service. In establishing separate payment for CCM services in the CY 2014 PFS final rule, we recognized that the resources involved in furnishing comprehensive, coordinated care management services to patients with multiple (two or more) chronic conditions were greater than those included in a typical non-face-to-face care management service, which we continued to consider as bundled into the payment for face-to-face E/M visits ( 78 FR 43337 ). In the CY 2017 PFS final rule, based on robust feedback from interested parties indicating that the new CCM codes did not fully capture the service time required to furnish care to beneficiaries with more complex conditions, we finalized new codes for patients with complex care management needs. In the CY 2016 PFS final rule, in considering how to improve the accuracy of our payments for care coordination, particularly for patients requiring more extensive care management, we stated that we believe the care coordination and management for Medicare beneficiaries with multiple chronic conditions, a particularly complicated disease or acute condition, or certain behavioral health conditions often requires extensive discussion, information-sharing, and planning between a primary care physician and a specialist (for example, with a neurologist for a patient with Alzheimer's disease plus other chronic diseases) ( 80 FR 70919 ).

We are proposing the Level 1 APCM code for patients with one or fewer chronic conditions because of the increased import and use of non-face-to-face interactions in advanced primary care even for patients with relatively fewer health needs, which has increased over time for several observable reasons, including broad evolution in information and communication technology in everyday life, diffusion of practices first adopted for higher-acuity patients, and continuing practices widely adopted during the COVID-19 pandemic that reduce reliance on in-person interactions. We believe APCM services for a patient diagnosed with one or fewer chronic conditions will require significantly less time and resources than one with two or more chronic conditions since, in general, there would be fewer ongoing health needs and other health care resources to coordinate, a lower risk of drug interactions, and less complicated physiology. Based on CY 2010 Medicare claims data, the difference in annual expenditures per beneficiary between patients with one or fewer chronic conditions and those with two or three chronic conditions was $3,673. [ 44 ] Our current care management coding similarly delineates patient complexity between patients with a single serious chronic condition (PCM codes) and those with two or more serious chronic conditions (CCM codes). We anticipate that practitioners who would furnish APCM services may have already had experience with care management services coding and payment for much of this population. The Level 1 APCM code would also address the current gap in coding and payment for care management services furnished using an advanced primary care model for patients without multiple chronic conditions.

We are proposing the Level 2 APCM code for patients with two or more chronic conditions because of the frequency of chronic conditions in the Medicare population. In fact, nearly four in five Medicare beneficiaries have two or more chronic conditions. [ 45 ] Furthermore, as noted previously, our current care management coding delineates patient complexity for the CCM codes for patients with two or more serious chronic conditions, and we anticipate that practitioners who would furnish APCM services may have already had experience with care management services coding and payment for much of this population.

For example, someone with chronic kidney disease and heart failure requires regular check-ins, coordination with specialty care, follow-up after hospital admissions for heart failure exacerbations, regular modifications of the care plan, and more. These services are typically described by the existing CCM services. The patient may also typically need to reach out more often to their primary care practitioner with questions or new symptoms via the patient portal. For instance, the person sends a message through the patient portal to ask whether or not they should come into the primary care office after gaining ten pounds in the last week—which could be a sign of increased fluid retention and the need for increased diuretic dosages to avoid pleural edema (an accumulation of fluid in the lungs). The primary care team books the patient for a same-day urgent care appointment to assess for signs of swelling and pleural edema. Again, this on-demand access to their primary care team can help treat the patient's chronic conditions in a patient-centered way and avoid unnecessary complications.

We are proposing the Level 3 APCM code for patients with QMB status and two or more chronic conditions based on our understanding that people with both multiple chronic conditions and social risk factors generally require even more time and resources from primary care practitioners and their teams to ensure that the patient's chronic conditions are managed appropriately and effectively. We are proposing to use a patient's QMB status as a method to identify beneficiaries with social risk factors that generally necessitate relatively greater resource requirements to effectively furnish advanced primary care than people without such risk factors. There is significant evidence that such dually eligible beneficiaries, on average, are more medically complex and have higher healthcare needs; [ 46 ] for example, dually eligible beneficiaries are more likely to have poor functional status [ 47 ] and recent expenditure data found that the difference in Medicare spending on a per person per year basis between dually eligible and non-dually eligible Medicare beneficiaries was $13,198 in CY 2021. [ 48 ]

QMBs are the largest eligibility group within the Medicare-Medicaid dually eligible enrollee population, comprising of 66 percent of the 12.8 million individuals per the most recent available data. [ 49 ] For the approximately 8.5 million dually eligible beneficiaries who are QMBs, Medicaid provides assistance for patients to meet Medicare's cost-sharing requirements. The QMB eligibility group helps to ensure full access to the Medicare benefit for the lowest income enrollees by covering these costs. Individuals can qualify for QMB status if their income is below 100 percent of the Federal Poverty Level ($15,300/year in 2024) and assets are no more than $9,430/$14,130 (one person/married couple in 2024), although states can request CMS approval to disregard certain income and assets. [ 50 ] Beneficiaries apply for this Start Printed Page 61707 benefit with their State's Medicaid program and must be redetermined eligible at least annually.

There is growing recognition that social risk factors—such as income, education, access to food and housing, and employment status—play a major role in health, [ 51 ] such that social risk factors may affect a person's ability to reach their health goals, as well as the diagnosis and treatment of their medical problems. A report submitted to Congress by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) in response to the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 ( Pub. L. 113-185 ) found that dual Medicare-Medicaid enrollment as a marker for low income was typically the most powerful predictor of poor outcomes on quality measures among social risk factors examined. [ 52 ] Beneficiaries with social risk factors may have worse health outcomes due to a host of factors, including higher levels of medical risk, worse living environments (for example, availability of community services, pollution, safety), greater challenges in adherence to medication regimens and medical recommendations (for example, diet/lifestyle), and/or bias or discrimination. Evidence suggests that many health outcomes are related more to social, environmental, and economic factors (which may be beyond practitioners' control) than to clinical interventions. [ 53 ] Dual enrollees, and more specifically, QMBs, are therefore a category of Medicare beneficiaries who we believe to be the most socially at-risk of poorer clinical outcomes. As stated in the ASPE report, “Some of the observed relationship between social risk factors and outcomes may be the result of underlying differences in medical complexity, frailty, disability, and/or functional status. For example, dually-enrolled beneficiaries are more likely to have poor functional status, and therefore, may be more likely to be readmitted after a hospitalization.” As another example, a patient with diabetes, heart failure, and QMB status may experience food, transportation, or housing insecurity that contributes to difficulty maintaining blood glucose control which can contribute to medical complications including potentially preventable heart failure exacerbations. The primary care practitioner's team may need to check-in regularly to ensure, for example, that the patient gets needed specialty care such as an ophthalmologic examination to avoid the ocular manifestations of diabetes; and consider the availability of transportation vouchers so the patient can attend the ophthalmology appointment. We are proposing the Level 3 APCM code to recognize the unique characteristics of QMBs as beneficiaries with social risk factors for whom significantly more resources are involved in comprehensive care management by practitioners that furnish advanced primary care services to them.

Additionally, we note that patients with QMB status are not responsible for the Medicare cost-sharing associated with covered Medicare Part A or B services, including for any APCM services. Generally, States cover such cost-sharing on behalf of QMBs, although many states use a “lesser-of” policy through which states pay less than the full cost sharing amounts. [ 54 ] We solicit comments from States on how they would cover cost sharing for the proposed APCM bundle, considering lesser-of policies.

We are also seeking feedback on the use of QMB status and multiple (two or more) chronic conditions as the basis to bill for APCM Level 3 (GPCM3), whether QMB status is an appropriate indicator to identify beneficiaries with added social risk, and whether there is an equivalent marker of social deprivation for use in commercial markets that might be a possible alternative identifier.

All the elements within the scope of APCM services are included in the service descriptors for GPCM1, GPCM2, and GPCM3, listed in Table 22, and described in this section. As described above, we are proposing that APCM services would include nearly the same scope of service elements and conditions we established for CCM and PCM services (including elements of 24/7 access and care continuity, care management and care plan, care coordination, management of care transitions, and enhanced communication). We believe this is appropriate because care management is a key component of care delivery using an advanced primary care model. The proposed phrasing in the code descriptors for APCM services generally tracks the code descriptors for CCM and PCM services, except for references to “time spent” or “minutes” of service.

We are seeking to ensure that the APCM codes would fully and appropriately capture the care management and CTBS services that are characteristic of the changes in medical practice toward advanced primary care, as demonstrated in select CMS Innovation Center models. As we do for CCM and PCM services, we propose to require for APCM services that the practitioner provide an initiating visit and obtain beneficiary consent (see section II.G.2.c.(1) and II.G.2.c.(2) of this proposed rule). As described in more detail below, we are proposing to incorporate as elements of APCM services “Management of Care Transitions” and “Enhanced Communications Opportunities.” For the “Management of Care Transitions” APCM service element, we are proposing to specify timely follow-up during care transitions (see section II.G.2.c.(6) of this proposed rule). For the “Enhanced Communications Opportunities” APCM service element, we are proposing to incorporate access to CTBS services, including remote evaluation of pre-recorded patient information and interprofessional telephone/internet/EHR referral service(s), to maintain ongoing communication with the patient, as well as access to patient-initiated digital communications that require a clinical decision, such as virtual check-ins and digital online assessment and management and E/M visits (or e-visits) (see section II.G.2.c.(8) of this proposed rule).

We are also proposing to specify for APCM services the practice-level characteristics and capabilities that are Start Printed Page 61708 inherent to, and necessarily present when a practitioner is providing covered services using an advanced primary care delivery model. As described in more detail below, included in the service descriptors for GPCM1, GPCM2, and GPCM3, and listed in Table 22, our proposed practice-level capabilities that reflect care delivery using an advanced primary care model are focused around 24/7 access and continuity of care (see section II.G.2.c.(3) of this proposed rule), patient population-level management (see section II.G.2.c.(9) of this proposed rule), and performance measurement (see section II.G.2.c.(10) of this proposed rule). These practice capabilities are indicative of, and necessary to, care delivery using an advanced primary care model. Further, APCM services, as we propose to define them, could not be fully performed in the absence of these practice capabilities; and, in such cases, APCM services should not be billed.

We are proposing that practitioners participating in the ACO REACH model, the Making Care Primary model, and the Primary Care First model would satisfy the proposed initiating visit, patient population-level management, and performance measurement APCM service elements and practice-level capabilities by virtue of their model participation. These CMS Innovation Center models promote advanced primary care delivery consistent with the proposed APCM service elements and practice-level capabilities described in Table 21. The models all utilize attribution methods that review the most recently available two years of Medicare claims to identify whether a model participant is responsible for a Medicare beneficiary's primary care, aligning with the initiating visit requirements for APCM services. Additionally, these three models also include risk stratification and quality and cost performance metrics that are aligned or overlap with the Value in Primary Care MVP. [ 55 ] Around-the-clock access and continuity of care, patient population-level management, and performance measurement are indicative of, and necessary to, care delivery using an advanced primary care model. We are also considering whether certain practitioners in other types of CMS Innovation Center models also satisfy the proposed service elements and requirements and seek comments on this question.

We are seeking comment on whether the proposed elements and requirements are appropriately reflective of care management services for advanced primary care, and whether there are proposed elements of APCM services or proposed practice capabilities that should be modified or removed. We are also seeking feedback on ways to align the APCM services with other Medicare programs and initiatives, such as the Shared Savings Program, ACO REACH, and advanced primary care models, and the Quality Payment Program, including MIPS and Advanced Alternative Payment Models (Advanced APMs). We seek to create a low burden way for practitioners to furnish APCM services by appropriately recognizing ways in which they may meet APCM billing requirements as part of these programs and initiatives. We note that under the Quality Payment Program, practitioners who are MIPS eligible clinicians would report measures and activities as specified by CMS under the four MIPS performance categories: quality, cost, improvement activities, and Promoting Interoperability (PI). To report to MIPS for a performance period (§ 414.1320(i)) for the PI performance category, a MIPS eligible clinician must use Certified EHR Technology (CEHRT), as defined at paragraph (2) under CEHRT at § 414.1305, report on the objectives and associated measures as specified by CMS, and submit required attestations as specified in § 414.1375(b)(3) (§ 414.1375(b)). Eligible clinicians who participate in Advanced APMs under the Quality Payment Program are required under the terms of those APMs to use CEHRT as specified in § 414.1415(a)(1)(iii); and are paid under the terms of those APMs based on MIPS-comparable quality measures as specified in § 414.1415(b).

As described in the sections below, we are proposing that a billing practitioner who is part of a Shared Saving Program ACO, or CMS Innovation Center ACO or participating in Making Care Primary or Primary Care First would already satisfy the proposed practice-level requirements for patient population-level management (see section II.G.2.c.(9) of this proposed rule), and performance measurement (see section II.G.2.c.(10) of this proposed rule) by meeting separately applicable participation requirements within the Shared Savings Programs and models. As noted previously, we are considering whether practitioners in other types of CMS Innovation Center models also satisfy certain proposed service elements and practice-level requirements through their participation in the models, and seek comments on this question.

Consistent with other care management services, we are proposing that the beneficiary's consent to receive APCM services must be documented in the medical record as a condition of payment for APCM services, as not all Medicare beneficiaries for whom APCM services would be medically necessary may want to receive these services. As we do for CCM and PCM services, we are proposing to require billing practitioners to inform the beneficiary of the availability of APCM services, and ensure the beneficiary is aware that Medicare cost-sharing usually applies (though these costs may be covered through supplemental health coverage). The practitioner should also inform the beneficiary that, by providing APCM services, they intend to assume responsibility for all of the patient's primary care services and serve as the continuing focal point for all needed health care services; and that only one Start Printed Page 61711 practitioner can furnish and be paid for APCM services during a calendar month, but that their consent to receive APCM services does not limit their option to receive Medicare covered health care services from other practitioners. The practitioner should inform the beneficiary that APCM is an ongoing, monthly service and of their right to stop APCM services at any time (effective at the end of the calendar month), and that they only need to provide consent once to receive APCM services from the practitioner. We are proposing that the practitioner would document in the beneficiary's medical record that this information was explained and note whether the beneficiary accepted or declined APCM services. We note that practitioners can still elect to obtain written consent rather than verbal consent.

Practitioners have informed us that beneficiary cost sharing is a significant barrier to provision of similar care management services, such as CCM services. The proposed patient consent requirement is intended to ensure that patients do not incur unexpected expenses for care that is largely, or in significant part, non-face-to-face in nature. The proposed requirement for patient consent would also help to avoid duplicative practitioner billing, as the patient would understand that the practitioner intends to serve as the focal point for all their care, and that only one practitioner can furnish and be paid for APCM services in any particular month.

We seek feedback on these proposed requirements, including how best to effectively educate both practitioners and beneficiaries on the benefits of APCM, especially as it reflects a new bundle of services that may have previously been separately billed, and whether a CMS-provided template to facilitate patient consent would be helpful. We also seek feedback on whether CMS should require practitioners to revisit consent for APCM services on an ongoing basis with patients.

Consistent with CCM services (CPT codes 99437, 99439, 99487, and 99489-99491) and PCM services (CPT codes 99424-99427), we are proposing to require an initiating visit for APCM services only for new patients instead of for all beneficiaries receiving APCM services. Consistent with the definition of “new patient” as described in the CPT® 2024 Professional Edition Code Book on page 4, we are proposing to define a “new patient” as a person who did not receive any professional services from the physician or other qualified health care professional or another practitioner in the same group practice within the previous 3 years. [ 56 ] The initiating visit furnished in advance of APCM services establishes the beneficiary's relationship with the billing practitioner, ensures the billing practitioner assesses the beneficiary prior to initiating APCM services, facilitates collection of comprehensive health information to inform the care plan, and provides an opportunity to obtain beneficiary consent (although beneficiary consent can be obtained outside of the initiating visit). We are proposing that the same services that can serve as the initiating visit for CCM services could serve as the initiating visit for APCM, including a Level 2 through 5 E/M visit, initial preventive physician exam (IPPE), or TCM service, and we propose that the initiating visit could be provided in person or as a Medicare telehealth service.

We are proposing that an initiating visit would not be required for “established patients” based on certain circumstances that we believe demonstrate an established patient-practitioner relationship in advance of furnishing APCM services: (1) if the beneficiary is not a new patient (has been seen by the practitioner or another practitioner in the same practice within the past three years) or (2) if the beneficiary received another care management service (including an APCM service, non-complex or complex CCM service (CPT codes 99487, 99489, 99490, 99491, 99439, 99437), or PCM service (CPT codes 99424, 99425, 99426, 99427)) within the previous year with the practitioner or another practitioner in the same practice. We do not believe there necessarily is a need for an initiating visit for APCM services for patients with whom the practitioner (or another in the same practice) has an established relationship; and we would not want to require an initiating visit under circumstances where a visit may not be medically necessary. The proposed policy not to require an initiating visit for beneficiaries who have received any professional service from the physician or other qualified health care professional or another practitioner in the same group practice within the previous 3 years is consistent with CPT's definition of the term “established patient,” such that we believe this captures patients who have been seen relatively recently and who have an existing relationship with the practice. In the case of beneficiaries who have received care management services from a practitioner within the practice in the past year, we believe this indicates that the patient is also an “established patient” in that the patient has an existing relationship with the practice, and the patient previously has consented to the receipt of care management services, which have overlapping service elements with APCM services.

We note that these standards would be consistent with applicable Shared Savings Program and CMS Innovation Center patient attribution standards in ACO REACH, Making Care Primary, and Primary Care First. Any beneficiary eligible to be assigned to an ACO because of an established care relationship between the beneficiary and a billing practitioner who would be billing for APCM services under the ACO participant's TIN, including beneficiaries who voluntarily aligned to a practitioner in the ACO, would not be considered a new patient and would not require an initiating visit. Medicare rules governing patient attribution to an ACO on the basis of care provided by an ACO-participating clinician similarly establishes where an existing care relationship exists. Similarly, beneficiaries eligible to be assigned to a REACH ACO, or a Making Care Primary or Primary Care First practice because of an established care relationship between the beneficiary and a billing practitioner who would be billing for APCM services under the model participant's TIN, including beneficiaries who voluntarily aligned to a practitioner participating in one of these three models would not be considered a new patient and would not require an initiating visit. While we are proposing certain exceptions to the initiating visit requirement for APCM services, we note that an initiating visit may still be needed even when not required, and the billing practitioner can always furnish and bill for medically necessary visits, including before initiating APCM services.

We seek feedback on these proposed requirements, including whether additional services could serve as the initiating visit and whether a different period of time (for example, patients not seen within one or two years) would be more appropriate.

Access and continuity build on the patient-practitioner relationship to ensure patients receive the right care at the right time from the right care team member. We are proposing to include for APCM services the same scope of service elements we established for CCM and PCM services for 24/7 Access Start Printed Page 61712 and Continuity of Care with some modifications. For 24/7 Access to Care, the scope of the service element we propose for APCM services would be to provide 24/7 access for urgent needs to the care team/practitioner with real-time access to patient's medical records, including providing patients/caregivers with a way to contact health care professionals in the practice to discuss urgent needs regardless of the time of day or day of week.

As described in the CY 2017 PFS final rule, this accurately reflects the potential role of clinical staff or call-sharing services in addressing after-hours care needs, and that after-hours services typically would and should address any urgent needs and not only those explicitly related to the beneficiary's chronic conditions ( 79 FR 67722 ). In advanced primary care models of care, primary care practices should be at the center of that care—providing an effective “first contact” for patients, supporting patients in their management of care, and coordinating across different settings of care. Achieving this level of access to primary care requires timeliness and an effective relationship with those in the practice who are providing that care. True access is fully informed by knowledge about the patient and their care, which is only possible through real-time access to the patient's electronic health information. Access to primary care, informed by health information technology (IT), makes the right care at the right time possible, potentially avoiding costly urgent and emergent care. Practices can achieve 24/7 access to care informed by health IT through call coverage by a practitioner with health IT system access. This can be a practitioner from the practice or a covering practitioner who has system access. Many practices and systems use nurse call lines or answering services working with standard protocols to provide the initial point of contact after hours and effectively address common problems. In this situation, an escalation protocol will engage a practitioner with system access when needed for decision making. Other successful practices expand hours, add urgent care services or partner with other practices to provide these services, or contract with existing urgent care providers to manage and coordinate care after regular office hours.

For Continuity of Care, the scope of service element would be to provide continuity of care with a designated member of the care team with whom the patient is able to schedule successive routine appointments. Continuity of care refers to the ability of patients to receive care from practitioners who know them and are known by them. This continuity builds and reinforces a relationship based in trust and shared experience that is highly valued by both practitioners and patients. Practice focus on continuity of care can translate to improved preventive and chronic care, patient and practitioner satisfaction, lower hospital utilization, and lower costs. [ 57 ] Depending on the type and setting of care, there are three components of continuity that improve patient outcomes and experience: [ 58 ] relational continuity (defined as the “ongoing therapeutic relationship between a patient (and often their family/caregiver)” which is foundational in advanced primary care), informational continuity (where practitioners have access to information on patients' past events and personal circumstances to inform current care decisions); and longitudinal continuity (which refers to ongoing patterns of healthcare visits that occur with the same practice over time). A key strategy to optimize continuity is ensuring that all practitioners and/or the care team have access to the same patient information to guide care within health IT, and successful practices start with a review and discussion of the practice-level data developed through measurement of continuity. [ 59 ] Practices can develop the capability to measure continuity of care between the patient and the practitioner/care team using health IT, practice management software, or other tracking mechanisms, allowing them to track improvements over time.

As included in the APCM code descriptors, we are proposing to specify for the “24/7 Access to Care” APCM service element that the practice would maintain the capability to deliver care in alternative ways to traditional office visits to best meet the patient population's needs, such as e-visits, phone visits, home visits, and/or expanded hours. This proposed standard for alternatives to office visits is similar to several requirements tested in CMS Innovation Center models (such as the CPC+ model's requirement that participating practices regularly offer at least one alternative to traditional office visits [ 60 ] ), and reflects the understanding that providing alternatives to traditional office visits is an essential element of the delivery of care under an advanced primary care model of care. Moving care out of traditional office visits can reduce demand and open supply for prioritized visits. By changing where and how care is delivered, practices may have increased availability for patients with complex needs who may be better served by more time-intensive visits in the office, at home, or in a nursing home. We are not proposing that a practice would need to regularly deliver care in all these alternative ways—for example, a practice may routinely offer e-visits and phone visits, but not regularly furnish home visits, and still demonstrate this primary care practice capability. Another practice might offer extended hours on certain days to help patients who may find it hard to take off work to see their clinician, and this would satisfy this practice requirement.

We seek feedback on these proposed requirements.

We are proposing for APCM services the “Comprehensive Care Management” service element we established for CCM and PCM services with some modifications. Rather than “care management for chronic conditions,” the APCM service element would be “overall comprehensive care management” which, like the element for CCM and PCM services, may include, as applicable, “systematic assessment of the patient's medical, functional, and psychosocial needs; Start Printed Page 61713 system-based approaches to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and oversight of patient self-management of medications.” This care management standard is similar to several requirements tested in CMS Innovation Center models (such as the CPC+ model's requirement that participating practices provide targeted, proactive, relationship-based care management to all patients identified as at increased risk and likely to benefit from intensive care management and provide short-term care management, including medication reconciliation, to patients following hospital admission/discharge/transfer, including observation stays, and, as appropriate, following an ED discharge) [ 61 ] and is an essential element of the delivery of care under an advanced primary care model of care. Care management is a resource-intensive process of working with patients, generally outside of face-to-face office visits, to help them understand and manage their health, navigate the health system, and meet their health goals. Practices working with patients who have complex care needs have found care management to be an effective and necessary strategy for mitigating risk and improving health outcomes. Practices have found it valuable to think in terms of two broad types of patients who might benefit from different approaches to care management: patients with some combination of multiple comorbidities, complex treatment regimens, frailty and functional impairment, behavioral and social risks, and serious mental illness who would often benefit from long-term, proactive, and relationship-based longitudinal care management; and patients who are otherwise stable and will benefit from short-term, goal-oriented episodic care management during periods of increased risk like transitions of care; diagnosis of a new, serious illness or injury involving complex treatment regimens; or newly unstable chronic illness.

Successful practices use on-site, non-physician, practice-based, or integrated shared care managers to provide longitudinal care management for the highest risk cohort of patients, with assistance from other practice staff, as needed. Multiple team members may engage in care management, but each patient identified as eligible should have a clinically trained individual in the practice who is accountable for active, ongoing care management that goes beyond office-based clinical diagnosis and treatment. [ 62 ] Longitudinal care management is captured in health IT and includes providing proactive care that moves beyond traditional office visits or crisis-driven care (for example, ED care or hospitalization) and is not primarily visit-based. Although office visits are opportunities to define goals, plan patient care, engage in shared decision making, and build a trusting relationship, most care management activities take place by phone, patient portal, email, mail, or home visits (and through visits to skilled nursing facilities or hospitals to support transitional care).

Practices use the concept of episodic care management to identify patients who have acute or urgent needs using “triggering events” (for example, hospital discharge, new diagnoses, medical crisis, major life event, decompensation in otherwise controlled chronic condition) for short-term, problem-focused care management services. Episodic care management is generally time-limited and problem focused and most often includes coordination of services and follow-up, patient education and support for self-management, and medication reconciliation.

We are proposing for APCM services the “Comprehensive Electronic Care Plan” service element we established for CCM and PCM services with some modifications. As included in the APCM code descriptors, we are proposing to specify that the care plan is “patient-centered” which, as for CCM and PCM services, “is available timely within and outside the billing practice” as appropriate to individuals involved in the beneficiary's care, can be routinely accessed and updated by care team/practitioner, and “copy of care plan to patient/caregiver.”

Providing longitudinal care management, which is an essential element of the delivery of care under an advanced primary care model of care, includes the process of personalized care planning. The personalized care planning process helps practices engage and collaborate with patients to ensure that their care aligns with patient preferences, goals, and values. [ 63 ] A care plan is a mutually agreed-upon document that outlines the patient's health goals, needs, and self-management activities and is accessible to all team members providing care for the patient. The care plan should be patient-friendly, accessible to the patient, and should limit use of unfamiliar medical jargon and acronyms. The care plan should also be structured and standardized, documented in health IT to enable sharing among patient, caregivers, and care team members. All high-risk patients receiving longitudinal care management should have a personalized care plan developed in a joint, open-ended conversation between the patient and care team. Personalized care planning is a dynamic process; therefore, the care plan document should be updated at regularly defined intervals by the care team and patient. In addition, when patients' health status, preferences, goals, and values change, their plans of care should, too.

As described in the CY 2020 final rule, we proposed language to describe the “typical” care plan elements which do not comprise a set of strict requirements that must be included in a care plan for purpose of billing but are intended to reflect those that are typically included in a care plan as medically appropriate for a particular beneficiary. The comprehensive care plan for all health issues typically includes, but is not limited to, the following elements: problem list; expected outcome and prognosis; measurable treatment goals; cognitive and functional assessment; symptom management; planned interventions; medical management; environmental evaluation; caregiver assessment; interaction and coordination with outside resources and practitioners and providers; requirements for periodic review; and when applicable, revision of the care plan.

We are proposing to adopt for APCM services the “Management of Care Transitions” service element we established for CCM and PCM services with some modifications. Rather than Start Printed Page 61714 requiring that the practice must facilitate communication of relevant patient information through electronic exchange of continuity of care documents with other health care providers regarding these transitions, we are proposing more simply to require the billing practitioner to “ensure timely exchange of electronic health information” with other practitioners and providers. As included in the APCM code descriptors, we are also proposing to specify for the “Management of Care Transitions” APCM service element that the care team/practitioner would follow up with the patient and/or caregiver within 7 days after each ED visit and hospital discharge. This proposed timely follow-up standard is similar to several requirements tested in CMS Innovation Center models (such as the CPC+ model's requirement that participating practices ensure patients with ED visits received a follow-up interaction within one week of discharge [ 64 ] and the MCP model's requirement that participating practices implement episodic care management to provide timely follow-ups for high-risk patients post ED visit and hospitalization [ 65 ] ), and we patterned the timely follow-up element after our policy for TCM services which requires, for example, “communication (direct contact, telephone, electronic) with the patient and/or caregiver with 2 business days of discharge” and a “face-to-face visit within 7 calendar days of discharge.” Providing timely follow-ups for patients is an essential element of the delivery of care under an advanced primary care model of care, and we believe this will help achieve timely, seamless care across settings especially after discharge from a facility. Key aspects of follow-up after ED visits and hospitalizations include identifying and partnering with target hospitals and EDs where the majority of a practice's patients receive services to achieve timely notification and transfer of information following hospital discharge and ED visits. [ 66 ] When developing a standardized process for data exchange and timely follow-up, successful practices include the following processes: information and data exchange about patients seen in an ED or admitted to/discharged from a hospital (for example, via HIE, hospital portal, hospital-generated report, EHR, or additional health IT system); definition for “timely” follow-up after discharge (for example, no later than within 2 days of discharge from hospital admission or observation stay and within 1 week of discharge from the ED); protocols for when follow-up will be done (for example, before discharge or following a standardized follow-up protocol); process of incorporating into the patient's medical record so the information is available at the time of the follow-up visit or other patient contact; and standardized processes and protocols for data exchange and formalized partnerships to develop an efficient workflow to ensure timely follow-up and facilitate efficient and safe transitions of care.

Practices use a variety of scheduling strategies to prioritize same-day or next-day access for acutely ill patients and to provide timely follow-up for patients experiencing care transitions. Successful practices are those that can strike the right balance between timely access to visits and the offering patients a provider of their choice (Continuity of Care). Establishing standardized protocols and pathways to improve and ensure responsiveness and timely callbacks to patients is an effective way to impact patient-practitioner/care team communication and to ensure a safeguard for addressing emergent and urgent patient phone calls. Successful practices routinely evaluate the degree to which patients' phone calls are answered promptly or returned within a practices' established guidelines (for example, non-urgent, emergent, urgent) and routed to the appropriate practitioner or care team member, incorporating patients' clinical needs and preferences. [ 67 ] Such strategies are paramount for practices whose patients may be contacting the practice with care needs that require care team prioritization and urgent reply.

We are proposing to adopt for APCM services the “Home- and Community-Based Care Coordination” service element we established for CCM and PCM services with some modifications. As included in the APCM code descriptors, we are proposing to specify that the “ongoing communication and coordinating receipt of needed services” is with not only with home- and community-based service providers, but also with “practitioners,” “community-based social service providers, hospitals, and skilled nursing facilities (or other health care facilities), as applicable.” We are also proposing to add more detail about the communication documented in the patient's medical record in that it would include “the patient's psychosocial strengths and needs, and functional deficits, goals, preferences, and desired outcomes, including cultural and linguistic factors.”

Coordinated referral management with specialty groups and other community or healthcare organizations ensures referrals are properly managed, coordinated, and communicated. These efforts help practices achieve goals of enhancing the quality of patient care, improving the patient's care experience, and lowering cost, particularly for practices serving high-risk patient populations. Evidence suggests that the development of formal relationships (for example, collaborative care agreements) between the primary care practice and referred groups/organizations that define shared goals and responsibilities, facilitate the coordinated referral management process. [ 68 ] The foundation of successful coordinated referral management with specialty groups and other community or healthcare organizations is the development of processes and procedures to ensure high-value referrals, such as collaborative care agreements and electronic consultations (e-Consults). Establishing clear and agreed-upon expectations regarding communication and clinical responsibilities with specialty practices and other care organizations, through a collaborative care agreement, improves the process. Collaborative care agreements often Start Printed Page 61715 include the following elements: defining the types of referrals, consultation, and co-management arrangements available; specifying who is accountable for which processes and outcomes for care within the referral, consultation, or co-management arrangement; and specifying what clinical and other information should be provided, how the information is transferred, and timeliness expectations. The electronic e-Consults process is typically conducted through a system-wide EHR or a secure, web-based system by which a practice receives guidance from a specialty provider or other care organization. [ 69 ] In this process, a practitioner sends a clinical question and relevant clinical information to the specialist (or other care organization), who responds by providing a clinical opinion and guidance and/or confirms the need for a face-to-face appointment with the patient. This tool and process has the potential to streamline consultations, reduce cost and burden for patients, and improve access to specialty care for high-value referrals. As part of the CY 2019 PFS final rule, we finalized interprofessional consultation services codes, which support payment both to the treating, requesting (primary care) practitioner (CPT code 99452) and the receiving, consultative specialist (CPT codes 99446-99449 and 99451) who engage in e-Consults, and so some practitioners have already become accustomed to providing and billing for these services.

Strategies for addressing common health-related social needs (HRSNs) for a practice's high-risk patients include conducting needs assessments at regular intervals, creating a resource inventory for the most pressing needs of the patient population, and establishing relationships with key community organizations. Practices can focus on developing relationships with community-based organizations that support patients' most significant HRSNs. Practices can also seek to find common ground with community and social service organizations, focus on the structure and process of referrals, and develop a bidirectional flow of information. Successful practices work with their patients to ensure there is a shared understanding of the purpose of the referral and aim to understand bottlenecks and barriers to meeting their needs through the process. Many practices identify a care team member to be a community referral resource for their patients. Successful referrals can help practices determine the most useful and available resources in their community.

We are proposing to include for APCM services the element of “Enhanced Communications Opportunities” we established for CCM and PCM services with some modifications. Specifically, we would add “internet and patient portal” as examples of asynchronous non-face-to-face consultation methods and specify that the practitioner would provide “other communication technology-based services, including remote evaluation of pre-recorded patient information and interprofessional telephone/internet/EHR referral service(s), to maintain ongoing communication with patients, as appropriate” as well as specify “access to patient-initiated digital communications that require a clinical decision, such as virtual check-ins and digital online assessment and management and E/M visits (or e-visits).” Providing asynchronous non-face-to-face consultation methods and other CTBS services is an essential element of the delivery of care under an advanced primary care model of care, and we believe this will allow patients to access their usual source of care more conveniently (see section II.G.2.c.(3) of this proposed rule). There is growing consensus that incorporating telehealth into primary care will allow patients to access their usual source of care more conveniently. [ 70 ] Patients using telehealth visits have reported high satisfaction, identifying convenience and perceived high quality of care as contributors, [ 71 ] such that these may be a good alternative and, in some cases, preferable to in-person communication. [ 72 ] Expansion of telehealth to address episodic and chronic conditions has been a significant trend in the evolution of telehealth applications, and there is some evidence that video visits may enable more timely communication of test results than in-person appointments.

As noted in section II.G.2.b. of this proposed rule, we are not proposing timeframe restrictions for this proposed element, which includes access to certain CTBS (for example, the restriction for virtual check-in services that there is not a related E/M service provided within the previous 7 days or an E/M service or procedure within the next 24 hours or the soonest available appointment).

As specified in the proposed APCM code descriptors, we are proposing to establish an APCM service element for Patient Population-Level Management that would include practice capabilities for population-based, data-driven approaches to manage preventive and chronic care for their patient population and to plan and implement strategies to improve care and outcomes. We are proposing that all practices would use data to develop clear improvement strategies and analytic processes to proactively manage population health, including analyzing patient population data to identify gaps in care and risk-stratifying the practice population based on defined diagnoses, claims, or other electronic data to identify and target services to patients (such as those at risk for poor health outcomes), and then would offer additional interventions, as appropriate.

These proposed patient population-level management standards are similar to several requirements tested in CMS Innovation Center models, including CPC+, which found that model participants used data to identify and resolve gaps in care. We have modeled the proposed patient population-level management standards on the CPC+ care delivery requirements. In the CPC+ Model, participating practices were required, for example, to “use a two-step risk stratification process for all empaneled patients, addressing medical need, behavioral diagnoses, and health-related social needs” and “define at least one subpopulation of patients with specific complex needs, develop capabilities necessary to better address Start Printed Page 61716 those needs, and measure and improve the quality of care and utilization of this subpopulation.” [ 73 ] Central to the delivery of advanced primary care is the organization of the practice into care teams that have the data they need to manage their patient populations and that have time allocated to plan and implement practice improvement strategies. [ 74 ] Using evidence-based protocols, registries, and the registry functionality of the EHR, reminders and outreach help practices deliver appropriate preventive care and consistent evidence-based management of chronic conditions for the entire patient population. [ 75 ] Measurement of clinically relevant data at the practice-level guides testing and implementing strategies to improve care and outcomes. Patient population-level management capabilities are essential to the delivery of care under an advanced primary care model of care and enable practices to meet the preventive and chronic care needs of their entire patient population. Regular use of data to identify populations or groups of patients with similar needs allows practices and care teams to use streamlined strategies, including setting goals with measurable outcomes, to positively impact their patient populations. Evidence shows that primary care teams supported with real-time, population-level clinical outcomes data effectively manage population health and address care gaps which eliminates external costs to close gaps in care. [ 76 ] More specifically, risk stratification allows practitioners to identify beneficiaries for longitudinal care management, track beneficiaries with higher levels of need and manage their conditions, and prevent beneficiaries from falling through the cracks, while developing strategies to address those patients who are at increased and rising risk and most likely to benefit from targeted, proactive, relationship-based care management and other strategies essential to APCM. [ 77 ] Empanelment, which assigns each active patient to a practitioner and/or care team with consideration of patient and caregiver preferences, allows practices to build responsive care teams to optimize patient care and to address the preventive, chronic, and acute needs of all patients, and provides a way for practices to identify care gaps and proactively reach out to patients who have not been seen or contacted in a while. [ 78 ] For example, we believe these elements of advanced primary care management could increase screening rates and ultimately improve care of chronic conditions, such as hypertension and diabetes.

We note that this Patient Population-Level Management requirement of the APCM services would be met for practitioners billing for APCM services through a TIN that is participating in an ACO in the Shared Savings Program by virtue of the practitioner's participation in the ACO which must meet eligibility requirements for population management, care coordination and quality improvement, including required processes and patient-centeredness criteria in § 425.112. We note that ACOs in the Shared Savings Program and their practitioners are already engaged in analyzing the patient population for care gaps, risk-stratifying patients to further identify those at risk for poor health outcomes, and identifying patients for whom additional interventions are appropriate. Similarly, the ACO REACH, Making Care Primary, and Primary Care First CMS Innovation Center Models all require their participants to deploy population health strategies to identify and offer interventions to mitigate health risks. [ 79 ] Participants in these models and their practitioners are already engaged in population health management as described in Table 21.

We are proposing for the APCM services a practice-level requirement of performance measurement of primary care quality, total cost of care, and meaningful use of CEHRT. Performance measurement is a critical element of care management services delivered in the context of advanced primary care, and it forms the basis for practice improvement efforts by enabling practices to identify key measures for improvement activities (for example, cost and utilization data, clinical quality measures, patient experience of care data). Quality measurement improves care delivery, including prevention of heart attacks, increasing vaccination rates, and improving patient safety, [ 80 ] and quality measures are also effective tools to ensure that high-quality advanced primary care, including care management, is being delivered. Several performance measurement requirements were tested in CMS Innovation Center models (such as the CPC+ model's requirement that participating practices use data at both the practice- and panel-level to set goals to improve population health management and to continuously improve patients' health, experience, and quality of care, and decrease cost). Using data resources and developing workflows and analytics to guide practice changes can help practices achieve reductions in total utilization and cost of care, and improvements in patient experience and quality of care. Improving upon key outcome measures requires engaged clinical and administrative leadership and a commitment to continuous, data-driven improvement. [ 81 ] In the context of the PFS, performance management through quality measurement as a practice-level requirement also ensures integrity to the provision of advanced primary care because it holds billing practitioners accountable to factors that are affected by several service elements of APCM coding. For example, effective patient-population level management can mean the practices close care gaps in diabetes management, and the billing practitioner would perform better on diabetes quality measures that assess for a patient's control of hemoglobin A1c.

We are proposing that this performance measurement practice-level requirement can be met in several ways. For MIPS-eligible clinicians, the requirement would be met by registering for and reporting the “Value in Primary Care” MIPS Value Pathway (MVP). A practitioner who is part of a TIN that is participating as a Shared Savings Program ACO or a REACH ACO, or a Primary Care First or Making Care Primary practice would meet these requirements by virtue of the Shared Savings Program and CMS Innovation Center quality reporting, assessment of quality performance, accountability for total cost of care, and other program and model requirements.

In the CY 2024 PFS final rule ( 88 FR 80042 through 80047 ), we finalized “The Value in Primary Care” Merit-based Incentive Payment System (MIPS) Value Pathway (MVP), which focuses on the clinical theme of promoting quality care for patients in order to reduce the risk of diseases, disabilities, and death; and it includes cost measures, Promoting Interoperability (PI) measures, improvement activities, and quality measures for common chronic conditions (for example, hypertension, diabetes, depression). [ 82 ] The Value in Primary Care MVP contains the Adult Universal Foundation quality measure set, which is consistent with the National Quality Strategy goal of using the Universal Foundation measures across as many programs as is feasible. [ 83 ] This MVP is especially well-suited to reflect the delivery of care using the advanced primary care model as it was developed to include quality metrics that reflect clinical actions that should be considered the foundations of primary care. The quality measures include key elements such as cancer screening, immunization, blood pressure management, behavioral health, care coordination, person-centered care, and screening for social drivers of health. The improvement activities include engaging community resources to address drivers of health, implementing changes in the practice's patient portal to improve communication and patient engagement, reviewing practices in place on targeted patient population needs, and chronic care and preventive care management for empaneled patients, aspects of advanced primary care already discussed in this proposal. The cost measures include costs for common chronic conditions, such as asthma/chronic obstructive pulmonary disease (COPD), diabetes, depression, and heart failure, as well as the Total Per Capita Cost (TPCC) measure, which assesses the overall cost of care delivered to a patient with a focus on the primary care they receive from their provider(s) and captures the broader healthcare costs influenced by primary care. [ 84 ] The Value in Primary Care MVP serves to demonstrate performance measurement that is reflective of the care furnished using advanced primary care delivery. To ensure performance measurement consistent with the delivery of advanced primary care services, we are proposing as an element of the APCM services that a practitioner who is a MIPS eligible clinician as defined in § 414.1305 can satisfy the performance measurement requirement by registering for and reporting the Value in Primary Care MVP for the performance year in which they bill for APCM services. A MIPS eligible clinician can report to MIPS as an individual, subgroup, group, APM Entity, or in any combination of these four participation options, and can participate in multiple ways to report MVPs. [ 85 ]

MIPS-eligible clinicians who report the MVP are also required to report the PI performance category measures and attestations throughout the performance period in which they bill for APCM services, [ 86 ] as required under § 414.1375(b) (§ 414.1365(c)(4)(i)) (see section IV of this proposed rule for details on reporting the objectives and measures for the MIPS PI performance category for CY 2025 performance period/2027 MIPS payment year). The measures in the MIPS PI performance category include measures such as electronic referral loops, receiving and reconciling health information, and providing patients with electronic access to their health information, all of which are reflective of important communication and coordination channels between primary care, other specialist practitioners caring for the patient, and the patient themselves. In addition, as set forth in 42 CFR 414.1375(b)(3) , the MIPS PI performance category also requires submission of affirmative attestations: (1) regarding their cooperation in good faith with ONC direct review of their CEHRT; and (2) that they did not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of CEHRT. [ 87 ]

For CCM services (CPT codes 99437, 99439, 99487, and 99489-99491) and PCM services (CPT codes 99424-99427), we established that practitioners must use CEHRT to record certain patient health information in a structured format, provide patients with access to their health information, and exchange all relevant patient health information, including in providing the “Management of Care Transitions” element of CCM services. For the APCM services, which are furnished as part of a practitioner's care delivery using the advanced primary care model, we are proposing for practitioners who are MIPS eligible clinicians a practice-level requirement to register for and report the MVP, including but not limited to the PI performance category measures which focus on meaningful use of CEHRT, ensuring that patients/caregivers and physicians or other qualified practitioners or clinical staff have real-time access to patient's medical information. We believe that comprehensive CEHRT use is a critical element of care management services delivered in the context of advanced primary care.

As we stated in adopting the CEHRT use element for CCM and PCM services, we believe that the meaningful use of CEHRT is vital to ensure that practitioners are capable of providing the full scope of services, such as timely care coordination and continuity of care (see our prior discussion of this issue at 79 FR 67723 and 84 FR 62696 ), and we believe that flexibility in how practices can provide the requisite 24/7 access to care, continuity of care, and management of care transitions, can facilitate appropriate access to these services for Medicare beneficiaries. The meaningful use of CEHRT helps ensure that members of the care team have timely access to the patient's most updated health information and offer an integrated view of a patient's clinical history from different points of care, supporting continuing, quality, and integrated healthcare while avoiding duplication of efforts and costs, such as Start Printed Page 61718 repeated exams. [ 88 ] For example, practices use EHRs to identify high-risk patients with chronic conditions to better coordinate care and can supplement the practice's EHR data with data from external sources (for example, State-level quality organizations) to obtain a more comprehensive view of patients. Practices can also integrate clinical data from EHRs, health plan claims data, and county-level social services data to evaluate population needs, stratify by risk, and assess what programs would be most effective for supporting at-risk patients. [ 89 ] Standardized communication methods, enabled by CEHRT, are a significant part of the advanced primary care delivery model. Health IT systems that include remote access to the care plan or the full EHR after hours, or a feedback loop that communicates back to the primary care physician and others involved in the beneficiary's care regarding after-hours care or advice provided, are extremely helpful. [ 90 ] They help ensure that the beneficiary receives necessary follow up, particularly if the patient is referred to the ED, and follow up after an ED visit is required under the element of “Management of Care Transitions.” Accordingly, we believe the use of CEHRT or remote access to the care plan is fundamental to providing the APCM service elements of 24/7 Access to Care, Continuity of Care, and Management of Care Transitions under an advanced primary care delivery model. Requiring performance of the requirements in these measures and attestations to the meaningful use of CEHRT is similar to several requirements tested in CMS Innovation Center models (such as the PCF model's requirement that participating practices adopt and maintain CEHRT for electronic clinical quality measure reporting, support data exchange with other providers and health systems, and connect to their regional health information exchange (HIE), [ 91 ] and the MCP model's requirement that participating practices use EHR technology that has been certified under the ONC Health IT Certification Program [ 92 ] ). Furthermore, the Shared Savings Program requires practitioners (that is, MIPS eligible clinicians, QPs and Partial QPs) in all ACOs to demonstrate meaningful CEHRT use through the reporting of the MIPS Promoting Interoperability annually beginning in 2025.

We recognize that many practitioners who are not MIPS eligible clinicians for a year would be excluded from MIPS by achieving Qualifying APM Participant (QP) status based on their levels of participation in an Advanced APM. Based on the characteristics of Advanced APMs detailed in § 414.1415, including the requirement that payment is based on MIPS or MIPS-comparable quality measures, practitioners who with QP status are necessarily engaging in performance measurement through the Advanced APMs in which they participate in a way that is consistent with advanced primary care. We also recognize there are other practitioners who are not MIPS eligible clinicians for other reasons, such as practitioners who are newly enrolled in Medicare or bill a low volume of Medicare services. These practitioners technically could bill for APCM services. However, newly enrolled practitioners are only excluded from MIPS for one year, after which the practitioner would either be a MIPS eligible clinician who would need to report the MVP in order to bill for APCM services, or excluded from MIPS on another basis such as QP status. In the case of practitioners with low Medicare volume, we anticipate that they would be unlikely to bill for APCM services since the delivery of advanced primary care generally involves time and resources to establish practice-level infrastructure, and the economies of scale usually make this a more likely investment if the infrastructure can be utilized across a larger patient panel.

We are also proposing that the performance measurement element of the APCM services would be satisfied for practitioners billing for APCM services through a TIN that is participating in a Shared Savings Program ACO for a performance year in which they furnish APCM services. ACOs are currently required to report the APP quality measure set on behalf of their practitioners, and would be required to report the APP Plus quality measure set as proposed in Section III.G. of this proposed rule. Practitioners in ACOs are also already being held accountable for reporting and performance and outcomes on many of the Universal Foundation measures already, which are used in the Value in Primary Care MVP, and the APP Plus quality measure set would fully align the Shared Savings Program's quality performance standard with the Universal Foundation measures upon the complete implementation of the APP Plus measure set.

We propose to include the performance measurement requirement as an element of APCM services furnished by practitioners. MIPS eligible clinicians who intend to report on the Value in Primary Care MVP for the CY 2025 must register to report the Value in Primary Care MVP as described under § 414.1365(b), a MIPS eligible clinician must register for an MVP during between April 1 and November 30 of the applicable CY performance period to report the MVP. MIPS eligible clinicians submit data on measures and activities in the first quarter of the year following (CY 2026) the MIPS performance period. Under this proposal, a MIPS eligible clinician billing for APCM services furnished in 2025 and who is satisfying the performance measurement requirement through reporting the Value in Primary Care MVP, would need to register for the MVP between April and November of 2025 and report data between January and March 2026 on measures and activities in the Value in Primary Care MVP relating to services furnished in 2025. A MIPS eligible clinician billing for APCM services furnished in 2026 and who is satisfying the performance measurement requirement through reporting the Value in Primary Care MVP, would need to register for the Value in Primary Care MVP between April and November of 2026, and report data between January and March of 2027 on measures and activities in the Value in Primary Care MVP relating to services furnished in 2026, and so on in subsequent years.

As described above, we are seeking feedback on ways to align the APCM services with other Medicare programs and initiatives, such as the Shared Savings Program and the Quality Payment Program, including MIPS and Advanced APMs. We seek to create a low burden way for practitioners to furnish APCM services by appropriately recognizing ways in which they may meet APCM billing requirements as part of these programs and initiatives, including other ways that practitioners may be fulfilling these performance measurement requirements. We are seeking feedback on whether there are areas of duplication within the APCM service elements and practice capabilities that we should consider addressing. We are also seeking comment on how to appropriately align Start Printed Page 61719 the time period for which the practitioner bills the monthly APCM code with the calendar year reporting period covered by the MVP, and how we would verify and enforce the performance measurement requirement of the APCM service.

In this section, we identify the services that would overlap substantially with APCM services based on the proposed elements of the scope of service for APCM which we have built into the service descriptors for GPCM1, GPCM2, and GPCM3 (see sections II.G.2.b. and II.G.2.c. of this proposed rule). As such, we are proposing that APCM services could not be billed by the same practitioner or another practitioner within the same practice for the same patient concurrent with these other services: CCM, PCM, TCM, interprofessional consultation, remote evaluation of patient videos/images, virtual check-in, and e-visits. Given that we have intentionally designed the proposed elements of APCM services to track closely with the elements of several other care management service and CTBS codes, these services are substantially duplicative of APCM services. Further, these specific services (shown in Table 19) are duplicative with APCM services because there is significant overlap in the patient populations included in the code descriptors for these services and APCM services, such as patients who have chronic conditions, high-risk conditions, or both complex and chronic conditions.

As we have described in the sections above, comprehensive care management services are essential to providing advanced primary care in the context of this proposal, and many of the service elements for CCM/PCM/TCM shown in Table 19 are substantially the same as the elements we are proposing for APCM services.

Also described above, providing CTBS is an essential element of the delivery of care under an advanced primary care model of care. Recognizing this, we designed the proposed APCM service elements to substantially overlap with the elements of the CTBS (for example, interprofessional consultation and e-Visits) shown in Table 22. CTBS are used in delivery of advanced primary care to maintain ongoing communication with patients and enable interprofessional care teams to provide comprehensive support to manage chronic conditions over time, which we believe will allow patients to access their usual source of care more Start Printed Page 61721 conveniently. [ 93 ] We also believe that interprofessional consultation can help promote integration of behavioral health and primary care. [ 94 ]

We also considered whether other care management services (such as Behavioral Health Integration (BHI)), services addressing HRSNs (Community Health Integration (CHI), Social Determinants of Health Risk Assessment, and Principal Illness Navigation (PIN)), and/or other CTBS (Remote Physiologic Monitoring (RPM) and Remote Therapeutic Monitoring (RTM)) would be duplicative of the proposed APCM services. We believe that these services, when appropriate, may complement APCM services rather than substantially overlap or duplicate services, and that these other services are sufficiently different from the APCM services in the nature and extent of the interventions and the qualifications of individuals providing the services, to allow concurrent billing for services when appropriate. While these may be services that a practitioner using the advanced primary care model would be likely to furnish, when appropriate, they are not part of the core, routinely and universally essential elements of the advanced primary care model. We also believe that several of these other services (such as BHI, CHI, SDOH Risk Assessment, and PIN) could be supplemental to APCM for patients that have very specific identified health care needs.

We are seeking more information from interested parties through our Advanced Primary Care RFI about whether to consider incorporating additional service elements into the APCM service elements and valuation for APCM codes; and whether and, if so, how to best incorporate E/M services into future coding (see section II.G.3. of this proposed rule). We note that, for BHI services, there is an established evidence base for approaches to caring for beneficiaries with behavioral health conditions which involve integration in the primary care setting, are typically provided by a primary care team, and include structured care management with regular assessments of clinical status and modification of treatment. BHI is a term that refers broadly to collaborative care that integrates behavioral health services with primary care. BHI is a team-based approach to care that focuses on integrative treatment of patients with medical and mental or behavioral health conditions. For BHI in particular, including CPT codes 99492, 99493, 99494, and 99484 and HCPCS code G0323, we are also seeking information regarding how evolving changes in practice may warrant reconsideration of payment and coding policies.

We propose that the care management and CTBS codes that are identified in Table 19 could not be separately billed with the APCM codes for the same beneficiary by the same practitioner, or a different one within the same practice, for the same service period. This would prevent duplicative payments for substantially similar services and is consistent with how we have paid for potentially overlapping care management services in the past.

As we refine our APCM policies, we note that we are not currently proposing to make changes to the coding and payment policies for the existing care management and CTBS services, other than to prohibit concurrent billing for the same patient during the same month by the same practitioner or another in the same practice. For CY 2025, those codes would still be available for practitioners who do not furnish care using the advanced primary care model or who may prefer to document the existing care management and CTBS codes rather than use the new proposed APCM codes.

We are also seeking comment on potential overlap between APCM services and other services currently paid under the PFS, including but not limited to care management and care coordination and other CTBS. If interested parties identify overlaps between APCM and other services, we are seeking comment on whether the degree of overlap would warrant a policy to restrict the services from being billed concurrently with APCM. We also seek comment on whether any overlap would depend upon whether the same or a different practitioner reports the services.

As we test new CMS Innovation Center models that include payments for the services defined above, including CCM, PCM, TCM, interprofessional consultation, remote evaluation of patient videos/images, virtual check-in, and e-visits, or as changes in the advanced primary care model of care or more general changes to Medicare payment policy take place that affect existing CMS Innovation Center models, consistent with existing policy, we will address potential overlaps between payments made to model participants with our proposed payment for APCM, elements of the proposed APCM service, and these duplicative services, and seek to implement appropriate payment policies.

To improve the accuracy of payment for the kinds of services furnished as part of advanced primary care and reduce the administrative burden associated with current coding and billing rules, we are proposing to create three HCPCS codes to use for reporting the proposed APCM service (GPCM1, GPCM2, and GPCM3) (sections II.G.2.b. and II.G.2.c. of this proposed rule). Although these codes are unique in that they would be created to differentially pay for advanced primary care management, the proposed APCM services incorporate elements of existing services with the understanding that some patients will require more resources and some fewer based on variability in patient complexity and needs (see section II.G.2.b of this proposed rule). As we ordinarily do, we are proposing to base the PFS valuation for APCM codes on the resources involved in furnishing the typical case of the service which may not necessarily reflect the actual resources involved in furnishing every individual service.

In this section, we detail our proposed methods to identify a typical case and set of resources involved in furnishing APCM, and the proposed valuation of these codes. To value APCM, we compared the service elements described by the proposed APCM codes to the values we have established for the specific care management and CTBS codes on which we modeled the proposed the service elements of the APCM codes and which we built into the service descriptors for GPCM1, GPCM2, and GPCM3 (see Table 19 and sections II.G.2.b. through II.G.2.d. of this proposed rule). As stated above, we believe that the proposed elements of APCM services reflect the comprehensive approach to care management involved in care delivery using the advanced primary care model. This is a model of primary care that is being integrated into current medical practice. As such, we believe that it would be appropriate to use the current valuation and uptake of the codes on which we modeled the APCM codes to inform our valuation of APCM services. Using Medicare FFS claims data and evidence from our primary care models, we sought to understand how these Start Printed Page 61722 different services have been used historically and relate that information to the way we are thinking about the service elements for APCM and the valuation of the three APCM code levels. We know that for Medicare beneficiaries who receive care management services during a year, the non-complex CCM base code is billed on average for five months and with three add-on codes during those five months. We also know that initial information from practitioner interviews conducted as part of our CCM evaluation efforts indicates that practitioners overwhelmingly meet and exceed the 20-minute threshold time for billing the non-complex CCM base code; typically, these practitioners reported spending between 45 minutes and an hour per month on CCM services for each patient, with times ranging between 20 minutes and several hours per month ( 81 FR 80244 ). However, this does not account for the care management services that are provided beyond one time-based billing interval and without reaching the next; nor does it account for the resources involved in maintaining certain advanced primary care practice capabilities and continuous readiness and monitoring activities, including patient population monitoring and care needs assessment, to fully furnish and bill APCM services as is medically reasonable and necessary for any individual patient during any calendar month. Finally, this does not account for changes to utilization of APCM that may occur as a result of the billing and documentation requirements for APCM services when compared to the current coding and payment for care management and CTBS services. While our aim is to value APCM services based on refined assumptions that we believe better recognize likely utilization of the new proposed codes and the work required to furnish APCM services, this is challenging without more information. We welcome comments on ideas for other sources of data that would help us to assess APCM services valuation.

We considered various alternatives for valuing the APCM services and how these may impact the broader health care landscape given that primary care is of such import across the country. We are proposing to set baseline APCM code values for this first year based on historical utilization of the care management services we have drawn upon in designing the APCM codes. We note that utilization of the care management services has been significantly higher than CTBS, and we found that CTBS are not typically billed for a patient in the same month as care management services. It is unclear whether the kinds of services described by the CTBS are not typically provided during these months or whether they are being provided but not separately reported. We will continue to seek information, including from public comments on this proposed rule, to help us identify the best approach to reflecting the proposed CTBS elements incorporated into the APCM monthly bundle, and we are particularly interested in data that could illuminate differences between what services are furnished and what is being reported separately. We will continue to consider refinements to the valuation of APCM codes to reflect available information about changes in the volume and mix of care management and communication activities being furnished as part of APCM services in the delivery of advanced primary care.

For APCM Level 1, we assumed the typical case would involve fewer resources than the current care management services based upon the proposed GPCM1 code descriptor and a broad eligible population that would require limited monthly APCM services; however, it would also involve certain resources inherent to maintaining advanced primary care practice capabilities and continuous readiness and monitoring activities, including patient population monitoring and care needs assessment, to fully furnish and bill APCM. As described in sections II.G.2.b. and II.G.2.c. above, certain elements of the APCM service require resources to maintain continuous readiness and monitoring activities to furnish covered services consistent with the advanced primary care model of care. We concluded that the APCM Level 1 services would be similar in work to that of two billing units of the non-complex code for CCM services (CPT code 99490 ( CCM services provided by clinical staff per calendar month )) over the course of a year, and therefore based the proposed inputs on CPT code 99490 multiplied by 1/6 (or 2 units over 12 months). Specifically, we proposed a work RVU for GPCM1 of 0.17, which is the work RVU for CPT code 99490 multiplied by 1/6 . The resulting proposed PE and MP RVUs are proportionately similar to those for CPT code 99490 and are available in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates ). [ 95 ] Table 23 displays payment amount estimates using the 2024 PFS Conversion Factor.

For APCM Level 2, which describes APCM services to patients with two or more chronic conditions we assumed the typical, higher intensity work associated with managing a patient with multiple chronic conditions would involve significantly more resources and require more, and more frequent, APCM service elements. We concluded that the APCM Level 2 services would be similar to current utilization assumptions of five billing units of the non-complex CCM code (CPT codes 99490) ( CCM services provided by clinical staff per calendar month ) and three billing units of add-on codes annually, given that, for Medicare beneficiaries who receive these CCM services during a year, the non-complex CCM base code is billed on average for five months and with three add-on codes during those 5 months. Additionally, we are proposing to account for what we believe to be continued underutilization of CCM services in this patient population by adding one billing unit of the complex CCM code (CPT code 99490 ( CCM services provided by clinical staff per calendar month ) annually. As we noted in the CY 2020 PFS final rule, “utilization [of CCM services] has reached approximately 75 percent of the level we initially assumed under the PFS when we began paying for CCM services separately under the PFS; while these are positive results, we believe that CCM services (especially complex CCM services) continue to be underutilized”, 81 FR 80244 and 84 FR 62688 , considering the number of eligible Medicare beneficiaries. In 2019, approximately 22.6 million FFS beneficiaries were identified as being potentially eligible for CCM (or 63.4 percent of the 35.6 million Medicare FFS beneficiaries); however, the use of CCM services was low among potentially eligible beneficiaries, such that just 4.0 percent of beneficiaries potentially eligible for CCM received any CCM services. [ 96 ] Therefore, we based the proposed inputs on CPT code 99490 multiplied by 5/12 (or, five units Start Printed Page 61723 over 12 months), plus CPT add-on code 99439 ( CCM services each additional 30 minutes by clinical staff directed by a physician or other qualified health care professional, per calendar month ) multiplied by 1/6 (or two units), plus CPT add-on code 99489 ( Complex CCM services each additional 30 minutes by clinical staff directed by a physician or other qualified health care professional, per calendar month ) multiplied by 1/12 (one unit), plus CPT code 99487 ( Complex CCM services provided by clinical staff directed by a physician or other qualified health care professional, per calendar month ) multiplied by 1/12 (one unit). Specifically, we proposed a work RVU for GPCM2 of 0.77, which is the sum of the work RVU for CPT codes 99490, 99439, 99489, and 99487 multiplied by their respective proportions above. The resulting proposed PE and MP RVUs are proportionately similar and are available in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates ). [ 97 ] Table 23 displays payment amount estimates using the 2024 PFS Conversion Factor.

For APCM Level 3 (HCPCS code GPCM3), which describes APCM services to patients with QMB status and two or more chronic conditions, we are proposing to value the service as a relative increase to the valuation of APCM Level 2 based on recent Medicare expenditure data for dually eligible Medicare beneficiaries. In CY 2021, per person per year spending on dually eligible beneficiaries was $24,370 and for non-dually eligible beneficiaries was $11,172. The difference between these two amounts is 218 percent. We have considered the likely resource demands and intensity of the practitioner-patient interaction for this patient population, consistent with our coding and valuation policies that reflect variations in resource cost and patient-centered care delivery policies. [ 98 ] By taking into consideration the difference in Medicare spending on a per person per year basis between dually eligible and non-dually eligible Medicare beneficiaries, we believe that we can capture the increased resources involved in furnishing APCM services to patients with QMB status and multiple chronic conditions. Therefore, we based the proposed inputs for the APCM Level 3 code on the APCM Level 2 inputs multiplied by 218 percent. Specifically, we proposed a work RVU for GPCM3 of 1.67, which is the proposed work RVU for GPCM2 multiplied by 218 percent. The resulting proposed PE and MP RVUs are proportionately similar to those and are available in Addendum B (see https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-a-b-updates ). [ 99 ] Table 23 displays payment amount estimates using the 2024 PFS Conversion Factor.

Table 23 includes the proposed placeholder codes (which, if finalized, will be replaced with numeric G-codes announced in the final rule), short descriptors, crosswalk codes, proposed RVUs (work, PE, and MP), and approximate payment rate. For illustration purposes, we multiplied the proposed APCM relative values for work, practice expense (PE), and malpractice (MP), without geographic adjustment, by the CY 2024 conversion factor (CF) ($32.7442) to convert the proposed relative value units (RVUs) into approximate national payment rates.

We are seeking feedback on whether these proposed values appropriately reflect the resource costs involved in furnishing these services, or whether adjustments to the proposed values or additional coding may be needed. We are broadly interested in public comments and input from interested parties on potential refinements in code and service definitions, including how we might refine our utilization assumptions for these codes, and other important information involving coding and payment for APCM services to better reflect the current practice of advanced primary care, including elements of CTBS and care management services. We are interested in developing a better understanding of the resource costs involved in furnishing comprehensive care management as part of advanced primary care to various patient populations, including specifically QMBs.

We intend to engage in further discussions with the public over the next several years to potentially refine our policies for 2025 and future years, and we expect that having APCM utilization data, once the proposed codes are established, would inform future refinement of the valuations for these codes.

Finally, as described in the Advanced Primary Care RFI that follows, we note that there is potential for the valuation of these codes and future related codes to change and/or scale into larger units if we expand them to incorporate more Start Printed Page 61724 service elements (see section II.G.3. of this proposed rule). As we receive more information about how these codes are being used and implemented in medical practice, we anticipate that these codes and future related codes will be refined over time. We note that the development of payment and coding policies for these and other kinds of services under the PFS is typically an iterative process that responds to changes in medical practice and may be best refined over several years through annual rulemaking for the PFS, and through the development of CPT codes by the AMA's CPT Editorial Committee.

As described in the next section, we believe that this new proposed APCM code set could serve as a chassis to incorporate primary care model learnings over time under the PFS and an additional pathway to accountable care for primary care practitioners.

Recent evidence reviews show that while primary care is the only part of the health system in which investments routinely result in not only improved outcomes but also increased equity, [ 100 ] the practice and sustainability of the primary care sector is under significant strain. [ 101 ] The NASEM found that many of these challenges relate to a primary care payment system that principally rewards visit volume versus creation and maintenance of longitudinal [ 102 ] care relationships over time. [ 103 ] We have set a goal of having 100 percent of traditional Medicare beneficiaries and the vast majority of Medicaid beneficiaries in accountable care relationships by 2030. Accountable care occurs when a person-centered care team takes responsibility for improving quality of care, care coordination and health outcomes for a defined group of individuals, to reduce care fragmentation and avoid unnecessary costs for individuals and the health system. [ 104 ] Advanced primary care is a core mechanism for achieving this goal. With this goal, we acknowledge the need to increase the capability of primary care clinicians to engage, maintain, and promote longitudinal and accountable relationships with beneficiaries through incentives and flexibilities to manage quality and total cost of care.

Over the past 11 years, the CMS Innovation Center has tested a number of primary care models: CPC, CPC+, Maryland Primary Care Program, PCF, as well as the upcoming MCP and ACO Primary Care Flex. Each of these primary care models has focused on testing what happens when we pay for primary care services with hybrid payments (a mix of fee-for-service and population-based payments), as described earlier. While these models have not met the criteria for expansion to date, the findings suggest advanced primary care may reduce unnecessary utilization and improve diabetes care and cancer screening rates.

In addition to testing new approaches to improve care for beneficiaries by supporting primary care, we have focused on approaches to incorporating these innovations into Medicare programs. For example, lessons learned from the CMS Innovation Center's ACO models may be incorporated into the Shared Savings Program. As such, part of the intent of our proposal to create new APCM payment and coding is that we would have a similar foundation to scale advanced primary care model learnings over time.

Previous Innovation Center primary care model tests have helped us learn lessons to inform our current and future work. For example, participants in primary care models have indicated difficulty investing in and maintaining primary care redesign activities due to a range of challenges. First, additional non-visit-based primary care payments have been generally layered upon base payments still predominantly FFS in structure. As such, the incentives and abilities of practices to focus on proactive, population-based non-visit activities may be limited if the funding stream for these activities is limited in scope and duration. [ 105 106 ] (Examples of non-visit-based activities include, but are not limited to: activities to improve care coordination, implement data-driven quality improvement, or enhance targeted care management for beneficiaries identified as high-risk.) Further, model funding for the clinical and administrative staff needed to accomplish advanced primary care coordination and population health functions is contingent on continued participation in these models. [ 107 ] Once the models end, practices are left without the funding that they received under the models for the clinical and administrative staff that had supported population health functions under the model. Moreover, because these models involve additional payments tied to performance rather than changes to base primary care payment, practices report that the funding they use to support non-visit activities is sometimes received well after the non-visit services have occurred, leading to further challenges sustaining these efforts fiscally. Solving these challenges is a key goal of future Innovation Center model work. [ 108 ]

To strengthen the primary care infrastructure within FFS Medicare, we are exploring opportunities to create new sustainable pathways to support advanced primary care, equitable access to high-quality primary care, and continued transformation among a wide variety of practices. One potential strategy to increase access to advanced primary care and prepare practitioners in traditional Medicare to engage in more accountable care is through the creation and ongoing refinement of specific billing and coding under the PFS that better recognizes advanced primary care and incorporates the resources involved in furnishing longitudinal care and maintaining relationships with patients over time. In section II.G.2. of this proposed rule, we are proposing a set of APCM services that make use of lessons learned from the CMS Innovation Center's primary care models, grouping existing care management and CTBS service elements into a bundle for use starting in CY 2025.

We are seeking feedback regarding potential further evolution in coding and payment policies to better recognize advanced primary care. Through this Advanced Primary Care RFI, we are committed to collaborating with Start Printed Page 61725 interested parties to lay the path for a more transparent movement to value-based care. Specifically, we are requesting input on a broader set of questions related to care delivery and incentive structure alignment and five foundational components:

Streamlined Value-Based Care Opportunities
Billing Requirements
Person-Centered Care
Health Equity, Clinical, and Social Risk
Quality Improvement and Accountability

We encourage input on the questions below from diverse voices, including beneficiaries and advocates, community-based organizations, providers, clinicians, researchers, unions, and all other interested parties.

We are seeking feedback regarding potential changes to coding and payment policies for advanced primary care services to be incorporated in traditional Medicare. For example, in the future, coding for APCM services (proposed in section II.G.2. of this proposed rule) could be revised to include additional service elements, including traditional E/M services. This Advanced Primary Care RFI is designed to solicit feedback on how we can further the goals of reducing administrative burden to refocus time on patient care; better recognizing the relative resources involved in furnishing care; recognizing interdisciplinary, team-based primary care; and supporting primary care sustainability and stability (especially for underserved communities). Whenever possible, respondents are requested to draw their responses from objective, empirical, and actionable evidence and to cite this evidence within their responses. We anticipate potential changes to primary care coding and payment policies, such as use of coding that recognizes groups of services furnished over a fixed time period, that would offer a new opportunity within the PFS for primary care clinicians to move to payment structures that are not fully dependent on billing for each discrete component of overall care and act as a step toward accountability for the cost and quality of patient care. Therefore, we are seeking feedback on building advanced primary care payment mechanisms that create pathways to recognize how primary care practice has moved away from an encounter-based orientation toward population-based care. This Advanced Primary Care RFI is the first step in ensuring ample opportunity for public input, followed by notice and comment rulemaking in subsequent years.

We are seeking to create a steppingstone for primary care clinicians, including those new to value-based care, to move away from either encounters or other discrete components of overall care as the dominant method of primary care payment and toward payments in larger units that are better tied to the relative resource costs involved in population-based, longitudinal care. Feedback from interested parties has been helpful when considering how to scale the availability of payments into larger units, and incorporate population-based variability in resources, all while driving toward accountability, and person-centered care. Ultimately, to create more opportunities for beneficiaries to receive high-quality, accountable primary care, we are focused on creating multiple pathways to recognize delivery of integrated care across settings, and engagement in comprehensive, team-based, longitudinal care.

When considering the evolution of a hybrid payment system within the PFS, we seek input on the following questions:

How can CMS better support primary care clinicians and practices who may be new to population-based and longitudinal care management?
What are the primary barriers to providing particular strategies or supports needed for pediatric clinicians and practices?
How can CMS ensure that potential future advanced primary care payment will not induce clinicians to leave effective accountable care relationships and clinician networks that already produce positive results? Additionally, how can CMS support growth over time in existing effective accountable care relationships and clinician networks?
Should CMS evolve the proposed APCM services into an advanced primary care payment that includes E/M and other relevant services, or maintain a separate code set for APCM?
If E/M services are bundled together for advanced primary care payments, how can CMS ensure that there is not a disincentive for primary care clinicians to continue to provide E/M visits, or increase accountability to E/M visits as warranted?
As many codes depend on E/M visits (for example, as the base code for an add-on code, or to initiate specific care management activities), how should CMS consider the downstream impacts of incorporating E/M visits into advanced primary care payments?
Should CMS consider incorporating other CTBS services into advanced primary care hybrid payments, such as Remote Physiologic Monitoring and/or Remote Therapeutic Monitoring?
Should CMS consider incorporating other services that involve comprehensive care management and care coordination, such as Behavioral Health Integration, End-Stage Renal Disease Monthly Capitation Payment (ESRD MCP), Assessment/Care Planning for Cognitive Impairment, and/or Advance Care Planning?
Should CMS consider incorporating other services while the patient is under care of home health agencies or hospices, such as Care Plan Oversight?
Newly finalized HCPCS codes are eligible for use by other payers, including commercial insurers, state Medicaid agencies, and others. We note that value-based alignment is a key goal of CMS. If the APCM codes are finalized, they would be eligible for use by these other payers as well. To what extent are other payers interested in adopting the APCM codes? Are there any other changes that would be necessary for other payers to adopt the codes?
CMS has historically used information presented by the Relative Value Scale Update Committee to determine PFS payment rates. Are there other sources of data on the relative value of primary care services that CMS should consider when setting hybrid payment rates?

Previous CMS Innovation Center primary care models have provided key lessons learned about how to increase comfort with population-based payments, the importance of reducing the administrative burden of billing, and how to begin addressing gaps in equitable access to population-based payments. [ 109 ] Specifically, we have learned through Innovation Center initiatives that retrospective reconciliation or adjustment of payments for services rendered can be especially frustrating for practitioners, as it reduces the predictability and stability of payments. [ 110 ]

For these reasons, we are seeking to understand how advanced primary care hybrid payments can balance program integrity, high-quality care, payment stability, and clinician burden.

We seek input on the following questions:

How can CMS reduce the potential burden of billing for population-based and longitudinal care services?
Are there particular types of items or services that should be excluded from the advanced primary care bundle?
Are there particular services paid under the PFS today that should be included in the advanced primary care bundle?
Care management activities are currently billed monthly. What episode lengths should CMS consider when thinking about an advanced primary care bundle of services for hybrid payment? Include evidence to support the proposed episode length.
Should CMS attribute the advanced primary care clinical episode to a single clinician, or consider weighted attribution and payment for multiple entities or clinicians? How could weighted attribution and payment work? What rules or processes should CMS consider to attribute the episode?
Care management coding and payment have historically required an initiating visit prior to starting monthly billing, to ensure that the services are medically reasonable and necessary and consistent with the plan of care. Are there other ways that CMS could ensure the clinician billing APCM is responsible for the primary care of the Medicare beneficiary?
Care management coding and payment require beneficiary cost sharing. Has beneficiary cost sharing been a barrier to practitioners providing such services?
Consistent with the initiating visit requirement in the APCM proposal, should CMS require the billing of specific qualifying services for billing of an advanced primary care bundle that is larger in scale and scope than APCM?
Are there Health IT functions beyond what is proposed for APCM services that clinicians should be required to have to bill for an advanced primary care bundle? What should CMS consider in the design of the advanced primary care bundle to effectively incorporate Health IT standards and functionality, to support interoperability and the aims of advanced primary care?
Should CMS limit the types of non-physician clinicians that can bill for an advanced primary care bundle that is larger in scale and scope than APCM? If so, include evidence to support the restriction.
How should CMS reconcile instances where an advanced primary care bundle is billed, but primary care services are then billed for and provided by separate entities?

Person-centered care integrates individuals' clinical needs across providers and settings, while addressing their social needs. [ 111 ] We strive for better, more affordable care and improved health outcomes. Key to this mission are care innovations that empower beneficiaries and clinicians, while reducing the administrative burden of providing episode-based and longitudinal care management. We are seeking comment on how an advanced primary care code(s) could be structured to both increase efficiency and promote the use of high-value services.

What activities that support the delivery of care that is coordinated across clinicians, support systems, and time should be considered for payment in an advanced primary care bundle that are not currently captured in the PFS?
How can CMS structure advanced primary care hybrid payments to improve patient experience and outcomes?
How can CMS structure advanced primary care hybrid payments to ensure appropriate access to telephonic and messaging primary care services?
What is the best reporting structure to ensure that targeted services are delivered without causing undue or excessive documentation?
How can CMS facilitate coordination between primary care clinicians that bill for advanced primary care bundles and specialists to reduce costs and improve patient outcomes?

We define health equity as, “the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes.” [ 112 ] The CMS Framework for Health Equity lays out how we are working to advance health equity by designing, implementing, and operationalizing policies and programs that support health for all the people served by our programs, eliminating avoidable differences in health outcomes experienced by people who are disadvantaged or underserved, and providing the care and support that our beneficiaries need to thrive. [ 113 ] For advanced primary care hybrid payments, this may mean incorporating different types of social and clinical risk into the payment than have typically been considered in traditional E/M or care management codes.

Recent models such as ACO REACH [ 114 ] and Making Care Primary [ 115 ] have incorporated risk adjustment for social risk factors, such as Part D Low Income Subsidy enrollment status and Area Deprivation Index, to better capture factors relevant to care of the patient. We seek input on how advanced primary care billing and payment policy could be used to reduce health disparities and social risk. Furthermore, we are seeking to balance a simple payment structure that encourages the uptake of advanced primary care services, while ensuring that the risk adjustment method used to develop the payment rates incentivizes the appropriate coding of patient conditions and needs, including those that have previously been under-documented, such as dementia and patient frailty. [ 116 ]

What non-claims-based indicators could be used to improve payment accuracy and reduce health disparities, and how can CMS ensure that they are collected uniformly and documented consistently without unduly increasing administrative burden?
What risk factors, including clinical or social, should be considered in developing payment for advanced primary care services? Start Printed Page 61727
How can CMS account for apparent changes in risk that are due to changes in coding patterns rather than changes in health status?
What risk adjustments should be made to proposed payments to account for higher costs of traditionally underserved populations?
What indicators are used to capture added social risk in commercial insurance? Should CMS consider using these?
What metrics should be used or monitored to adjust payment to ensure that health disparities are not worsened as an unintended consequence?
How can CMS ensure that advanced primary care hybrid payment increases access to health care services for patients without a usual source of primary care?
Are there steps CMS can take to ensure advanced primary care billing and coding is utilized for dually eligible beneficiaries, and by safety net providers?
Should CMS incorporate Community Health Integration and/or Principal Illness Navigation services and payment into an advanced primary care bundle?

We are committed to affordable quality health care for all people with Medicare. We seek feedback regarding how we can continue to strengthen beneficiary access to high-quality health services within FFS Medicare. One goal of the CMS Innovation Center Strategy Refresh is to increase the capability of practitioners furnishing advanced primary care to engage in accountable care relationships with beneficiaries through incentives and flexibilities to manage clinical quality, outcomes, patient experience, and total cost of care. As such, part of the intent of evolving and creating over time advanced primary care hybrid payments is that the practitioners who bill for these services are engaged in a relationship where they are responsible for the quality and cost of care for the beneficiary, counting toward the overall 2030 goal of every person with Traditional Medicare being in an accountable care relationship. This Advanced Primary Care RFI seeks input from beneficiaries and their caregivers, primary care and other clinicians, and health plans on how advanced primary care bundles could support that goal.

How can CMS ensure clinicians will remain engaged and accountable for their contributions to managing the beneficiary's care?
What are key patient-centered measures of quality, outcomes and experience that would help ensure that hybrid payment enhances outcome and experience for patients?
How could measures of quality, outcomes, and experience guard against and decrement in access or quality?
As described in the APCM proposal, reporting of the “Value in Primary Care” MVP would be an APCM service element for MIPS eligible clinicians beginning in 2026. Since this MVP contains measures focused on both the total cost and quality of care, would its inclusion as an APCM service element be sufficient to count as “accountable care?” If not, what other service delivery or quality reporting would be expected in “accountable care?”
What should CMS consider so that that advanced primary care bundles could be used to promote accountable care across payers, both commercial and Medicaid?
What quality measures are other payers using to drive improvements in primary care?
What utilization measures are other payers using to drive improvements in primary care?
What patient experience measures are other payers using to drive improvements in primary care?
Should CMS consider flexibilities for smaller practices to bill the advanced primary care bundle? Should CMS consider flexibilities for entities exempt from MIPS to bill the advanced primary care bundle?
Would clinicians be willing to take on more accountability to further reduce the frequency and/or administrative burden of billing?
For APCM services, are there other key practice-level elements of the service that should be considered for advanced primary care practices to bill for advanced primary care?

Cardiovascular disease (CVD) is a leading cause of death, disability, and health care expenditures in the U.S. [ 117 ] The burden of CVD is unequal, with black Americans experiencing higher rates of CVD-related morbidity than white Americans. [ 118 ] Atherosclerotic CVD [ 119 ] is also distinct among leading causes of death for Americans in the proportion of CVD attributable to behavioral causes, [ 120 ] making improvement in modifiable CVD risk factors (for example, diet, exercise, smoking cessation) is a key treatment target to reduce the burden of CVD across populations. [ 121 ]

The CMS Innovation Center's Million Hearts® Cardiovascular Disease (CVD) Risk Reduction model [ 122 ] (hereafter referred to as Million Hearts® model) was launched in 2017 as part of the ongoing HHS Million Hearts® Initiative. [ 123 ] The model's goals were to decrease the incidence of first-time heart attacks and strokes among medium and high-risk Medicare beneficiaries over five years and reduce Medicare spending on cardiovascular events. The model was implemented as a randomized design where participant organizations in the intervention group agreed to (1) calculate traditional Medicare beneficiaries' risk of having a heart attack or stroke over 10 years, and (2) provide cardiovascular care management services to high-risk patients (defined as a risk of a cardiovascular event in the next decade of greater than thirty percent). The model also identified medium-risk patients (more than fifteen percent risk of an event in the next decade) in its evaluation. In exchange for doing so, CMS paid participant organizations $10 for each eligible traditional Medicare beneficiary for whom the organizations assessed risk, and in the first year of the model, $10 for each high-risk beneficiary during each month when cardiovascular care management services were provided. [ 124 ] In Start Printed Page 61728 subsequent years of the model (2018 to 2022) participants were expected to reassess cardiovascular risk and were paid based on cardiovascular risk reduction ($0 to $10 per beneficiary per month) for high-risk beneficiaries.

All CMS Innovation Center models are independently evaluated [ 125 ] and the evaluation of the Million Hearts® model found the model reduced the rate of death from any cause for medium and high-risk beneficiaries by four percent, as well as reduced the risk of death from a cardiovascular event (that is, heart attack or stroke) by eleven percent. [ 126 ] We consider this to be due to increased rates of cardiovascular risk assessment, discussion of cardiovascular risk by participants' clinicians, and the use of appropriate medications to reduce cardiovascular risk (for example, aspirin and statins). [ 127 ]

During the Million Hearts® (MH) model (which was tested from 2017-2022), there was a recently-introduced ASCVD risk assessment tool to incorporate demographic (age, sex, race), clinical (blood pressure, cholesterol, history of diabetes), and risk behavior (smoking status, use of anti-hypertensives, use of statins, use of aspirin) established by the American College of Cardiology (ACC), [ 128 ] as well as a longitudinal re-assessment tool used within the model. [ 129 ] This tool calculated the 10-year risk of a cardiovascular event for beneficiaries ages 40-79. Subsequently, additional ASCVD risk assessment tools have been developed. [ 130 ]

Today in clinical practice, ASCVD risk is generally calculated using a tool combining demographic data, personal history (risk behaviors and medical history), and laboratory data (lipid panel). [ 131 ] This information is used to calculate into a 10-year estimate of a patient's ASCVD risk for use in determining treatment advice provided by the treating practitioner. This determination requires both data collection at a visit and laboratory data, which may not be available at an initial visit. This change in clinical practice occurred over time after a series of guidelines from the American Heart Association (AHA) recommended using ASCVD risk in determining treatment decisions for patients without a prior history of CVD. [ 132 ] This treatment guideline also includes recommendations for lifestyle modifications for all patients. The CMS Innovation Center Million Hearts® model contributed to this change in clinical practice by demonstrating through a rigorous randomized control trial that the quantitative assessment of 10-year cardiovascular risk improves quality of care, including mortality, compared to prior practice. [ 133 ]

In the Million Hearts® model, cardiovascular-focused care management services included an initiating visit where an ASCVD risk assessment is performed, structured recording of patient health information using CEHRT, and a comprehensive care plan focused on cardiovascular risk reduction (including the ABCS focused on in the Million Hearts® model), but did not require 24/7 access to care, management of care transitions, or home and community-based coordination because these services are necessary for the management of complex conditions placing a beneficiary at high risk of death, acute exacerbation/decompensation, or functional decline, and these services are provided to prevent the development of these complex chronic conditions. In the Million Hearts® model, cardiovascular-focused risk management services were provided to beneficiaries at high risk for CVD (more than a thirty percent risk of a cardiovascular event in the next 10 years).

We interpret the findings of the Million Hearts® model to be both reflective of and perhaps augmenting an evolution in clinical practice toward quantitative ASCVD risk assessment. We also do not believe the resources involved in these activities are appropriately reflected in current coding and payment policies. As such, we are proposing to establish codes to describe a separately billable cardiovascular disease risk assessment that is furnished in conjunction with an E/M visit and cardiovascular-focused risk management, when reasonable and necessary due to the presence of increased cardiovascular risk factors identified for the individual patient.

We are proposing a new stand-alone G-code, HCPCS code GCDRA, Administration of a standardized, evidence-based Atherosclerotic Cardiovascular Disease (ASCVD) Risk Assessment for patients with ASCVD risk factors on the same date as an E/M visit, 5-15 minutes, not more often than every 12 months. Atherosclerotic Cardiovascular Disease (ASCVD) Risk Assessment refers to a review of the individual's demographic factors, modifiable risk factors for CVD, and risk enhancers for CVD. We are proposing this new code to identify and value the work involved in administering an ASCVD risk assessment when medically reasonable and necessary in relation to an E/M visit.

We further propose that the ASCVD risk assessment must be furnished by the practitioner on the same date they furnish an E/M visit, as the ASCVD risk assessment would be reasonable and necessary when used to inform the patient's diagnosis, and treatment plan established during the visit. ASCVD risk assessment is reasonable and necessary for a patient who has at least one predisposing condition to cardiovascular disease that may put them at increased risk for future ASCVD diagnosis. These conditions could include but are not limited to, obesity, a family history of CVD, a history of high blood pressure, a history of high cholesterol, a history of smoking/ Start Printed Page 61729 alcohol/drug use, pre-diabetes, or diabetes. We further propose that the ASCVD risk assessment would not be separately billable for patients with a cardiovascular disease diagnosis or those who have history of a heart attack or stroke.

We are not proposing any specific tool that would have to be used for the ASCVD risk assessment, although the assessment tool must be standardized and evidence-based. Proposed elements of the ASCVD risk assessment service would include:

Current (from the last 12 months) laboratory data (lipid panel) for inputs needed for the risk assessment tool.
Administration of a standardized, evidence-based ASCVD risk assessment tool that has been tested and validated through research, and includes the following domains:

++ The output of the tool must include a 10-year estimate of the patient's ASCVD risk. This output must be documented in the patient's medical record.

++ Demographic factors (such as age, sex).

++ Modifiable risk factors for CVD (such as blood pressure & cholesterol control, smoking status/history, alcohol and other drug use, physical activity and nutrition, obesity).

++ Possible risk enhancers (such as pre-eclampsia, pre-diabetes, family history of CVD).

++ Billing practitioners may choose to assess for additional domains beyond those listed above if the tool used requires additional domains. Examples of tools include but are not limited to, the ACC ASCVD Risk Estimator [ 134 ] and the ACC PREVENT tool. [ 135 ] CMS expects that the tool that is used would not introduce discriminatory bias, consistent with Section 1557 final rule.

We are proposing for HCPCS code GCDRA to have a duration of 5-15 minutes for the administration of an ASCVD risk assessment tool, billed no more often than once every 12 months.

We are requesting comments on these proposals, as well as information pertaining to potential clinician education for these proposed codes.

We propose a direct crosswalk to HCPCS Code G0136 ( Administration of a standardized, evidence-based SDOH assessment, 5-15 minutes, not more often than every 6 months ), with a work RVU of 0.18 as we believe this service reflects the resource costs associated when the billing practitioner performs the service described. HCPCS code G0136 has an intra-service time of 15 minutes, and the physician work is of similar intensity to proposed HCPCS code GCDRA. Therefore, we are proposing a work time of 15 minutes for HCPCS code GCDRA based on this same crosswalk to G0136. We are also proposing to use this crosswalk to establish the direct PE inputs for HCPCS code GCDRA.

Over the past several years, we have worked to develop payment mechanisms under the PFS to improve the accuracy of valuation and payment for the services furnished by physicians and other healthcare professionals, especially in the context of evolving changes in medical practice using evidence-based models of care, such as the Million Hearts® model. We are proposing to establish a G-code to describe ASCVD risk management services that incorporate the “ABCS” of CVD risk reduction (aspirin, blood pressure management, cholesterol management, and smoking cessation) for beneficiaries at medium or high risk for ASCVD (>15 percent in the next 10 years) as previously identified through an ASCVD risk assessment. We believe that ASCVD risk management services include continuous care and coordination to reduce or eliminate further elevation of ASCVD risk over time, and potentially prevent the development of future cardiovascular disease diagnoses or first-time heart attacks or strokes.

We are proposing new G-code, GCDRM, Atherosclerotic Cardiovascular Disease (ASCVD) risk management services with the following required elements: patient is without a current diagnosis of ASCVD, but is determined to be at medium or high risk for CVD (>15 percent in the next 10 years) as previously determined by the ASCVD risk assessment; ASCVD-Specific care plan established, implemented, revised, or monitored that addresses risk factors and risk enhancers and must incorporate shared decision-making between the practitioner and the patient; clinical staff time directed by physician or other qualified health care professional; per calendar month. Atherosclerotic Cardiovascular Disease (ASCVD) risk management services refer to the development, implementation, and monitoring of individualized care plans for reducing cardiovascular risk, including shared decision-making and the use of the ABCS of cardiovascular risk reduction, as well as counseling and monitoring to improve diet and exercise. We propose that the elements of the Atherosclerotic Cardiovascular Disease (ASCVD) risk management service would include:

ASCVD Specific Risk Management, which may include:

++ Promoting receipt of preventive services (including tobacco cessation counseling, diabetes screening, diabetes self-management training)

++ Medication management (including aspirin or statins to maintain or decrease risk of CVD)

++ Ongoing communication and care coordination via certified electronic health record (EHR) technology

—Synchronous, non-face-to-face communication methods must be offered

ASCVD-Specific, Individualized, Electronic Care Plan

++ Must address modifiable risk factors and risk enhancers specific to CVD, as applicable, such as:

—blood pressure and cholesterol control

—smoking, alcohol, and other drug use status, history, and cessation

—physical activity and nutrition

—obesity

++ Plan must be established, implemented, and monitored and must incorporate shared decision-making between the practitioner and the patient

Although there is no minimum service time requirement for ASCVD risk management services in a month, each of the proposed elements must be addressed to bill for the service, unless a particular element is not medically indicated or necessary at that time for that specific patient. For example, the element of smoking cessation would not be addressed for a patient who does not use tobacco. Documentation of each service element in the patient's medical record is required.

Physicians and non-physician practitioners (NPPs) who can furnish E/M services could bill for ASCVD risk Start Printed Page 61730 management services. We anticipate that ASCVD risk management services would ordinarily be provided by clinical staff incident to the professional services of the billing practitioner in accordance with our regulation at § 410.26. We are proposing that ASCVD risk management services would be considered a “designated care management service” under § 410.26(b)(5) and, as such, could be provided by auxiliary personnel under the general supervision of the billing practitioner.

We are proposing that patient consent must be obtained before starting ASCVD risk management services. Like other care management services, ASCVD risk management services would typically be provided by clinical staff outside of face-to-face patient visits. Consent can be written or verbal and must be documented in the medical record. Consent should also include informing the patient about these services, as well as potentially applicable Medicare cost-sharing.

We are proposing that ASCVD risk management services could be billed no more often than once per calendar month, and that payment is limited to one practitioner per beneficiary per month. Patients must be determined to be at medium or high risk for CVD (>15 percent in the next 10 years) as previously determined by the ASCVD risk assessment and must not have a current diagnosis of cardiovascular disease or have a history of heart attack or stroke.

We are seeking comments on each of these proposals.

We propose a direct crosswalk to CPT Code 99211 ( Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician or other qualified health care professional ), with a work RVU of 0.18 as we believe this service reflects the resource costs associated when the billing practitioner performs HCPCS code GCDRM. CPT code 99211 has a physician intraservice time of 5 minutes, and the physician work is of similar intensity to our proposed HCPCS code GCDRM. Therefore, we are proposing a work time of 5 minutes for HCPCS code GCDRM based on this same crosswalk to CPT 99211. We are also proposing to use this crosswalk to establish the direct PE inputs for HCPCS code GCDRM, with modifications to reflect non-face-to-face services. These modifications include eliminating PE inputs used in face-to-face services such as preparing and cleaning the room. We are seeking comments on these proposals.

Currently, there are approximately 4,100 physicians' services that are coded and valued under the PFS as global surgical packages (herein “global packages”). Global packages are single codes that are valued to include all services provided during a specified period of days (0-day, 10-day, or 90-day global packages) by a physician (or another practitioner in the same group practice (as defined at 42 CFR 411.352 )) for a specific surgical procedure. The Medicare Physician Fee Schedule (MPFS) look-up tool provides information on each procedure code, including the global surgery indicator. This tool is available at https://www.cms.gov/medicare/physician-fee-schedule/search/overview .

The global packages include:

The surgical procedure itself, including day-of pre-service activities and day-of recovery care;
Post-operative evaluation and management (E/M) visits and discharge services provided during specified post-operative periods (10- or 90-day periods for most minor and major procedures, respectively; 0-day global packages do not include post-operative visits);
Pre-operative visits on the day of the procedure (for services with 10- and 90-day periods) and pre-operative visits on the day prior to the procedure (for major procedures with 90-day periods only);
Services provided during the post-operative period (for services with 10- and 90-day periods) related to the procedure (for example, treatment of complications, pain management).

Any medical care that requires a return to the operating room during the global period is paid separately and starts a new global period. Like other services paid under the PFS, post-operative visits that are part of the global packages can vary by level and site of service. Global packages, including the pre-operative, day-of, and post-operative visits associated with the surgical procedure, are valued using our annual PFS rulemaking process.

As we discussed in the CY 2015 PFS final rule, we have identified and articulated several concerns with the global packages related to the accuracy of valuation and payment under the PFS. Foremost, we have longstanding concerns regarding whether the packages are valued based on estimates consistent with the number and kind of services actually being furnished. Findings from multiple OIG reports suggest that practitioners perform fewer post-operative visits than are expected and accounted for in the valuation of the global packages. We provided a detailed discussion of these concerns in the CY 2015 PFS final rule ( 79 FR 67582 through 67591 ). Similarly, we described concerns that global packages as currently constructed may cause potential distortions in valuation among PFS services, and that the structure of the current packages assumes a single model of care delivery (a single practitioner or other practitioners in the same group practice furnishing the surgical procedure and all associated care) and does not appropriately address scenarios where the surgical procedure and follow-up care are provided by different practitioners in different group practices. Taking these findings and concerns into account, we finalized a policy to transition all 10-day and 90-day global packages to 0-day global packages, which would allow any post-operative visits furnished after the day of the procedure to be billed separately as standalone visits by any practitioner who furnishes them. However, in 2015, through amendments made by section 523 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA; Pub. L. 114-10 , enacted April 16, 2015), we were prohibited under section 1848(c)(8)(A) of the Act from implementing this finalized policy. Further, under section 1848(c)(8)(B), we were required to collect data beginning in 2017 on the number and level of post-operative visits typically provided to patients during 10- and 90-day global periods and to use this newly collected data and other data beginning in 2019 to improve the accuracy of global package valuation.

In response to these requirements, over the past 9 years, we have:

Initiated research contracts and implemented a data-collection process to analyze data to understand the extent to which post-operative visits are furnished to patients and improve the accuracy of payment rates for the global surgical packages. This research contract was funded by CMS (HHSM-500-2014-00036I) and carried out within the Payment, Cost, and Coverage Program in RAND Health Care.
Released three reports (located at https://www.cms.gov/medicare/payment/fee-schedules/physician/global-surgery-data-collection ) on the number of E/M visits furnished during post-operative periods, the most recent finding that only 4 percent of expected post-operative visits in 10-day global Start Printed Page 61731 packages and 38 percent of expected post-operative visits following 90-day global packages were furnished to patients.
Fielded and released a report on a survey of selected global packages, collecting information related to the level and complexity of medical visits furnished during post-operative periods. This research contract was funded by CMS (HHSM-500-2014-00036I) and carried out within the Payment, Cost, and Coverage Program in RAND Health Care.
Released two reports on potential approaches for revaluing the global packages based on these findings.
Analyzed the prevalence of transfer of care modifiers (-54 for surgical care only; -55 for post-operative management only; and -56 pre-operative management only) applied to global packages.

More recently, in the CY 2023 PFS proposed and final rules, we reviewed the prior work and conversations around the accuracy of global package valuations and solicited comments from the public on (1) suggested strategies for revaluing these services, (2) information on how changes to healthcare delivery and payment may be impacting the relevance or accuracy of global package payments, and (3) possible impact of changes to global packages on health care access for beneficiaries (see 87 FR 69432 through 69437 ). In response to the comment solicitation in the CY 2023 PFS proposed rule, some commenters generally disagreed with our findings that the post-operative visits in the global packages are not performed as frequently as assumed in our valuation of global surgical packages. However, opposition from commenters was based on anecdotal assertions rather than alternative data. Many of these commenters' specific points restated earlier comments submitted in response to our request for feedback in the CY 2020 PFS proposed rule on claims-based reporting of post-operative visits, survey findings on the level of visits, and potential revaluation approaches. Some commenters supported eliminating 10-day global package periods and requested that the AMA RUC review these services. However, these commenters also acknowledged that the AMA RUC review process could take years. In addition to the comments we received in response to the CY 2023 PFS proposed rule, we have received feedback over several years from many interested parties regarding the findings from claims-based reporting of post-operative visits and considered revaluation methodologies presented in our prior reports.

Overall, we have continued exploring ways to improve the accuracy of valuation and payment for global packages to ensure appropriate payments to the practitioners providing pre-operative, surgery, and post-operative care to Medicare beneficiaries while considering feedback from interested parties. In addition, commenters have not proposed specific alternative strategies to revalue global surgical packages.

Separately, we continue to review approaches to better describe physicians' services in the context of the evolving care delivery landscape and to allow practitioners to furnish patient-centered care. Our review work includes considering care delivery models discussed with interested parties (and developed though our CMS Innovation Center work), reviewing our policies and billing requirements, identifying care elements that could serve as the building blocks for describing newer, impactful services, and seeking opportunities to reduce administrative burdens for practitioners while ensuring accurate payment. Through this lens, we have also recently reviewed our billing requirements and payment policies for the global packages, concurrent with continued analysis of the Medicare claims data.

While ongoing, our review highlights opportunities for us to clarify or revise longstanding policy and billing instructions for global packages, using data and experience gathered over the last several years, consistent with our overall objectives to pay more accurately for services and to right-size the valuation of PFS services based on how practitioners currently furnish these services. In this proposed rule, we discuss proposals (1) to revise our transfer of care policy for global packages to address instances where one practitioner furnishes the surgical procedure and another practitioner furnishes related post-operative E/M visits during the global period, and (2) to develop a new add-on code that would account for resources involved in post-operative care provided by a practitioner who did not furnish the surgical procedure. We believe that addressing the use of transfer of care modifiers, and the resources involved when practitioners who do not furnish the surgical procedure provide post-operative care, are essential steps in aligning payment with the way in which surgical procedures are currently furnished as evidenced in our data, and would make meaningful progress toward more accurate payment for these services in particular and improve relative valuation for PFS services overall.

We have valued global packages to include the surgical procedure and services furnished during the specified global period related to the surgical procedure when furnished by the practitioner who performs the surgery (hereafter in this section, the proceduralist) or by another practitioner in the same group practice as the proceduralist.

Under current Medicare payment policy, certain services furnished during the global period by the proceduralist or by another practitioner in the same group practice may be separately billed with an appropriate modifier:

Initial decision for surgery: E/M service billed with modifier -57 (Decision for Surgery).
E/M services unrelated to the procedure: billed with modifier -24 (Unrelated E/M Service During a Global Period).
Other services unrelated to the procedure (including underlying condition treatment, diagnostic tests, distinct procedures) not including care for complications/returns to the operating room: no modifier required.
Failure of a less extensive procedure requiring a more extensive procedure: no modifier required.
Organ transplant immunosuppressive therapy: no modifier required.
Critical care services unrelated to surgery: billed with modifier -FT if in the post-operative period.

In general, except where a formal transfer of care modifier applies, a practitioner other than the proceduralist or a practitioner in the same group practice as the proceduralist can bill separately for an E/M visit for services they furnish during the global period for a global package, including post-operative E/M visits related to the procedure. We established formal transfer of care modifiers to apply in cases where the work, time, and resources involved in furnishing services included in the global packages are split between the proceduralist (or another practitioner in the same group practice) and other practitioners providing related post-operative visits during the global period. Under our current transfer of care policy, transfer of care modifiers must be reported when a formal transfer of care arrangement is documented by both the proceduralist and another practitioner providing the related post-operative visits. Based on our analysis of Medicare fee-for-service Start Printed Page 61732 claims data, these formal transfer of care modifiers are rarely used and, when they are, it is often with respect to certain ophthalmologic procedures (for example, cataract surgery).

Based on our analysis of claims data, we believe that it may be helpful to review our current policy regarding the applicability of transfer of care modifiers for the medical and billing communities. Under our current policy, the scope of the global package extends to services furnished by the entire group practice of the proceduralist, including services furnished by practitioners in the group practice who are a different specialty from the proceduralist. In other words, the PFS payment for post-operative visits and other services furnished during the global period that are related to the surgical procedure and provided by the proceduralist or a practitioner in the same group practice as the proceduralist is bundled into the global package, and those services are not separately billable. If the proceduralist or a practitioner in the same group practice as the proceduralist wants to bill during the global period for a service furnished to the surgical patient, but unrelated to the global package, the correct modifier must be used to indicate that the service is not related to the global package. Without a modifier to indicate otherwise, during the global period for a global package, all E/M services furnished to the patient by the proceduralist or another practitioner in the same group practice as the proceduralist are presumed to be related to, and included in the payment for, the global package. Modifiers for separate payment (such as modifier -24) are required when services unrelated to the global package are billed by the proceduralist or a practitioner in the same group practice as the proceduralist during the global period.

We recognize that we are precluded under section 1848(c)(8)(A) of the Act from revisiting the policy we established in the CY 2015 PFS final rule to revalue all 10-day and 90-day global packages to 0-day global packages ( 79 FR 67582-67591 ). Further, we note that transitioning all global packages to 0-day global periods could take several years and require substantial CMS resources (see CY 2014 PFS final rule ( 77 FR 44737 through 44738 ) for previous discussion). We have also considered revaluing 10-day and 90-day global packages to reflect the observed number of post-operative visits furnished to patients based on data we have collected over nearly a decade and note that this approach would be quicker to implement, assuming there would be straightforward ways to revalue the services with the data. However, interested parties have continued to express uncertainty about the validity of claims-based counts of post-operative visits. This uncertainty stems primarily from CMS not having complete information surrounding the use of the transfer of care modifiers since they are not currently routinely used. The same interested parties also object conceptually to revaluing the 10-day and 90-day global packages using the “building block” framework, where each component of a service, including bundled post-operative visits, contributes to total valuation to align valuation with the number of post-operative visits typically provided to patients. Some interested parties have expressed larger concerns about the redistributive impacts across the PFS among specialties if we were to implement and revalue all global packages.

We acknowledge the practical challenges involved in revaluing 10-day and 90-day global packages, whether they remain as 10-day and 90-day periods with fewer post-operative visits or are transitioned to 0-day global packages, and continue to carefully consider how to best improve global package valuation given access to administrative claims data and other inputs that help us understand the scope of services provided to patients within global packages. Ultimately, we want to ensure payments to practitioners and the relative values assigned to global surgical packages are accurate and, to the extent possible, driven by real-world objective and updatable information regarding the relative resources involved in furnishing the services.

For CY 2025, we are focused on different aspects of our policy objectives for global packages and propose the following policies, which are not mutually exclusive, to obtain information and allow for more accurate payment to reflect time and resources spent on post-operative care associated with the current global packages. We will continue to assess and monitor for potential future opportunities to improve our payment approach for the global packages more broadly.

Additionally, in developing our proposed policies to pay more accurately for the global packages, we also considered whether, when, or how our policies may be affected when services are provided by the proceduralist, versus another practitioner who did not perform the procedure but is providing follow up care. We also recognize that there may be multiple practitioners in the same or different specialties in the same group practice and considered how our policies should apply to practitioners in a range of specialties within the same group practice. We are seeking comment on these considerations in the context of our proposed policies and welcome feedback that may further inform our payment policy for global packages. Additionally, as we continue to better understand what services are being furnished in the global period, by whom, and how the global surgical packages are valued and billed, we are seeking comment on how remote monitoring and other types of new technologies represent new resource costs and/or produce efficiencies and effectiveness of post-operative care. This information could be useful both for purposes of valuation for surgical and post-operative care, as well as for policies regarding when specific PFS codes should be reported during global periods for global packages.

We created transfer of care payment modifiers at the inception of the PFS. Under our current policy, these modifiers are required to be appended to the relevant global package code when billing for services that are within the scope of the global package (within the global period and related to the surgical procedure) only when the proceduralist and one or more other practitioners who are not in the same group practice as the proceduralist formally document their agreement to provide distinct portions of the global package.

The following transfer of care modifiers describe the different portions of the global surgical package that could be provided by different practitioners:

Modifier -54 Surgical Care Only: this modifier is appended to the relevant global package code to indicate that the proceduralist performed only the surgical procedure portion of the global package.
Modifier -55 Post-operative Management Only: this modifier is appended to the relevant global package code to indicate that the practitioner performed only the post-operative management portion of the global package.
Modifier -56 Pre-operative Management Only: this modifier is appended to the relevant global package code to indicate that the practitioner performed only the pre-operative portion of the global package. Start Printed Page 61733

For each of these modifiers, the payment for the global package is adjusted based on the applicable percentage noted in the PFS Relative Value files ( https://www.cms.gov/medicare/payment/fee-schedules/physician/pfs-relative-value-files ).

As previously noted, we currently require the transfer of care modifiers (-56 pre-operative care, -54 for procedures, and -55 for post-operative care) to be appended in cases where there is a formal documented transfer of care agreement, that is, “in the form of a letter or an annotation in the discharge summary, hospital record, or Ambulatory Surgical Center (ASC) record” (CMS Manual System, Pub 100-04 Medicare Claims Processing, Transmittal 11287). In our recent analyses of 2022 Medicare claims data, we identified that these modifiers were rarely used other than for certain ophthalmology global packages. We found over 99 percent of claim lines for 90-day surgical procedures billed with modifier -54 were ophthalmology services (primarily cataract-related procedures). We also identified a difference in the number of claim lines annually for a given 90-day global package with modifier -54 and with modifier -55. In other words, there are sometimes more claim lines billed with modifier -54 than there are corresponding lines with modifier -55 and vice versa during a year. We note that modifier -56 (pre-operative management only) is only very rarely used in practice. These recent observations suggest (1) the overwhelming concentration of reported transfer of care modifiers is in ophthalmology procedures, and (2) a potential mismatch in billing for formal transfer of care cases between proceduralists and other practitioners providing post-operative care.

While we recognize the benefits to continuity of care when the proceduralist also provides pre-operative and follow-up care for the procedure, we also recognize that it is not always feasible, or even perhaps typical practice for the same practitioner to furnish all portions of the global package; for example, in instances when the practitioner furnishing the procedure does not schedule a post-operative visit(s) on the day of the procedure or plans for the patient to follow up with their primary care provider, or when the practitioner performing the surgery arranges alternative follow-up care because it would be difficult for the beneficiary to travel to return for follow-up care. Because our current policies require use of the transfer of care modifiers only where there is a formal documented agreement between practitioners to provide specific portions of the global package, we believe there are many practical and potentially common circumstances under which the transfer of care modifiers would not be required or used.

Beginning for services furnished in 2025, we are proposing to broaden the applicability of the transfer of care modifiers for the 90-day global packages. We are proposing to require the use of the appropriate transfer of care modifier (modifier -54, -55, or -56) for all 90-day global surgical packages in any case when a practitioner plans to furnish only a portion of a global package (including but not limited to when there is a formal, documented transfer of care as under current policy, or an informal, non-documented but expected, transfer of care). Practitioners billing for a global package procedure code with modifier -54 and other practitioners in the same group practice as that practitioner would still be able to bill during the global period for any separately identifiable E/M services they furnish to the patient that are unrelated to the global package procedure. To do so, the practitioner would append modifier -24 to the claim line for the E/M service.

This proposed policy, which would be a first step toward improved valuation and payment while retaining the fundamental structure of the global packages, would provide us with more accurate information on the resources involved in furnishing components of global surgical packages. This proposal would prevent duplicative Medicare payment for post-operative care because the global surgical package payment would be adjusted based on the appended modifier, and payment for post-operative care would not be made both as part of a global surgical package and through separately billed E/M visits. We also anticipate that the proposed policy would provide us with insight into changes in standards of practice and post-operative patient care for services that are not billed with transfer of care modifiers pursuant to our current policy (that is, services other than certain ophthalmology procedures).

We acknowledge the potential challenge associated with anticipating whether other practitioners will furnish portions of the global package and, accordingly, appending the appropriate modifier when billing global package services.

We are interested in understanding and are seeking comment on the circumstances under which practitioners in separate group practices furnish different portions of the care included in global packages, and what that means for reporting the transfer of care modifiers. While we are making proposals related to the 90-day global periods beginning for services furnished in 2025, we are also seeking comment on whether we should consider proposing these changes for the 10-day global packages in future rulemaking.

Under our current policy for global packages where the transfer of care modifiers are used (required only where there is a formal transfer of care arrangement), the total combined PFS payment made for the global package during the global period does not exceed the total global surgical package payment established for the procedure when billed without any transfer of care modifier. In general, we continue to believe this is the appropriate result when more than one practitioner furnishes portions of a global package. Under our proposal, we would require that practitioners performing the surgical procedure but not intending to furnish the post-operative portions of a 90-day global service would appropriately append the -54 modifier that we have previously discussed, which would adjust the portion of payment received to accurately reflect the service furnished.

More specifically, as noted in the discussion above, the transfer of care modifiers correspond to three distinct portions of the global package (pre-operative services, the surgical procedure itself, and post-operative care). We have assigned a proportion of the global package payment to each portion of the service based on longstanding assumptions. Under our current policy, the payment for the entire global package is paid to the billing practitioner unless a transfer of care modifier is included on the claim. Payment is only adjusted if a transfer of care modifier is included on the claim. We are requesting comments, as we further develop our payment policies for global packages, on how best to determine the appropriate payment proportions for the three portions of the global package, which impact payment to the different practitioners who furnish the different portions of the service.

We are continuing to consider approaches to establishing the payment allocations for portions of the global package when the transfer of care modifiers are used, and anticipate revising the allocations through future rulemaking. We are seeking comment on Start Printed Page 61734 potential approaches to revise these payment allocations and how they could be established to better reflect current medical practice and conventions for post-operative follow-up care. We seek to identify a procedure-specific, data-driven method for assigning shares to portions of the global package payment to more appropriately reflect the resources involved in each portion. We would appreciate and carefully consider recommendations from interested parties, including the AMA RUC, on what those allocation percentages should be, based on how the global package codes are valued and any other relevant information.

We have contracted with RAND to support data collection and analysis in the past and, as identified in RAND's prior reports and described in detail, we surmise that the policy to apportion and pay for the three portions of the global package based on the presence of transfer of care modifiers does not always work smoothly. In considering RAND's reports, one reason for this is that fewer post-operative visits are provided to patients compared to the number of visits reflected in the valuation of global packages. The global packages reflect a certain number of post operative visits (noted in the Physician Time File) that typically occur during the post-operative global period. However, there is no easy way within a global package to separate the RVUs for the procedure itself from the RVUs for post-operative visits that are not typically provided to patients. If our allocation of the global package payment based on the presence of transfer of care modifiers were to undervalue the surgical procedure portion or the post-operative care portion of the global package, we are concerned that we could unintentionally introduce incentives that influence current medical practice for transfers of care. This gets at RAND's prior recommendation that we revalue global packages to reflect the actual number of post-operative visits provided to patients. After revaluation, separating the procedure and post-operative payments would reflect observed data and mitigate any possible inappropriate incentives in place for practitioners to initiate transfers of care and support use of transfer of care modifiers as medically appropriate. This approach has the advantage of anchoring the valuation of separate -54 and -55 components using real-world information on post-operative visits reported to CMS rather than on historical assumptions or current survey data reflecting estimates of the typical number and level of visits.

In our internal review of the percentages assigned for the pre-operative, surgical care, and post-operative portions of the global package, we found that there are a small number of codes that do not have any assigned percentages in our files even though these codes are identified as global packages. HCPCS codes 77750 ( Infusion or instillation of radioelement solution (includes 3-month follow-up care) ), HCPCS code 77761 ( Intracavitary radiation source applic simple ), HCPCS code 77762 ( Intracavitary radiation source applic intermed ), and HCPCS code 77763 ( Intracavitary radiation source applic complex ) do not have assigned percentages in our RVU files. It is our understanding, however, that the MACs have local edits in place to ensure appropriate payment for these services when billed with the transfer of care modifiers. We are seeking comment on whether we should consider, first, whether these codes are appropriately categorized as 90-day global package codes. If these are appropriately considered to be 90-day global package codes, we are seeking comment on what the assigned percentages should be for the pre-operative, surgical care, and post-operative portions of the service.

We recognize the importance of continuity in surgical and post-operative care. However, we recognize that there are instances where post-operative care is not furnished by the proceduralist or another practitioner in the same group practice, or even by a practitioner who is in the same specialty as the proceduralist, despite there being no formal transfer of care. We also recognize that there is an extra level of complexity involved when a practitioner sees a patient post-operatively after a surgical procedure performed by another practitioner in those circumstances. The practitioner providing the post-operative care may not be involved in creating the surgical plan, and may not have access to the operative notes to know how the surgery went or be abreast of any particular considerations related to the procedure that may factor in medical care decisions for the post-operative care. As such, we recognize that there are comparatively more resource costs incurred when a practitioner who did not furnish the surgical procedure in a global package provides the follow-up care. We are proposing to address these scenarios, which can occur in a few different ways, by establishing a new add-on code that would account for resources involved in post-operative care for a global package provided by a practitioner who did not furnish the surgical procedure and does not have the benefit of a formal transfer of care. However, we note that when a patient is seen by practitioners in the same group practice or specialty as the surgeon, the same resources are not incurred during follow-up and therefore, the add-on code should not be billed by another practitioner in the same group practice as the practitioner who performed the surgical procedure, or in the same specialty as the practitioner who performed the surgical procedure. In the case of a practitioner providing follow up care who is of a different specialty and not within the same group practice as the proceduralist, researching the procedure to determine expected post-operative course and potential complications may be needed, which would warrant using the add-on code. We also acknowledge that sometimes the proceduralist does not schedule the patient to follow up with them post-operatively and directs the patient to follow up with other practitioners as needed, such as with the patient's primary care provider. The patient may independently choose to follow up with their primary care provider or another practitioner based on other considerations such as convenience of the practice location or ease of scheduling. We understand and acknowledge that the patient can choose to see another practitioner without the knowledge of the practitioner who performed the procedure.

To more appropriately reflect the time and resources involved in these kinds of visits, we are proposing to make payment using a new add-on code to be billed with an office/outpatient E/M visit for post-operative follow-up care during the global period of a global package to capture additional resources associated with practitioners who were not involved in furnishing the surgical procedure. This follow-up care may include, but is not limited to, obtaining and reviewing the surgical notes and surgical history, monitoring for signs and symptoms of infection, taking into account any considerations from the surgical procedure that may affect the medical care, and monitoring for any potential post-operative complications that may arise. It is often difficult in these circumstances for the practitioner who did not perform the surgical procedure to know how the wound looked after the procedure, and so it is more challenging to recognize possible changes that may have occurred since Start Printed Page 61735 the time of the procedure (when this is something the operating surgeon would have been able to know). This new code would be billed by the practitioner who furnishes the post-operative office/outpatient E/M visits when that practitioner is not the proceduralist and is not in the same specialty or group practice as the proceduralist. Documentation in the medical record must justify use of the add-on code and that the E/M visit was, as clinically understood by the reporting practitioner, related to a post-operative visit furnished during the 90-day post operative period. As noted earlier, we are proposing to expand the required use of the transfer of care modifiers as a first step toward improving payment for the global packages to promote improved valuation and payment for these services. Instituting an add-on code to capture the time and intensity of post-operative work absent a formal transfer of care, would be an essential step in recognizing how the services are currently furnished and make meaningful progress toward `right-sizing' the structure of the global packages.

Given the history of the global packages since data collection began, as specified in section 1848(c)(8) of the Act, and in consideration of our policies for post-operative care and our proposal requiring the use of the transfer of care modifiers in a broader set of circumstances, we believe that the timing is appropriate to establish an add-on code and payment for post-operative care provided in the office/outpatient setting by a practitioner other than the proceduralist (or another practitioner in the same specialty) to account for the additional time, intensity, and resources that are involved in post-operative care. We are proposing a new HCPCS code, GPOC1, to capture the additional time and resources spent in providing follow up post-operative care by a practitioner who did not perform the surgical procedure and who has not been involved in a formal transfer of care agreement.

We propose the following code and descriptor for the proposed add-on code: GPOC1 ( Post-operative follow-up visit complexity inherent to evaluation and management services addressing surgical procedure(s), provided by a physician or qualified health care professional who is not the practitioner who performed the procedure (or in the same group practice), and is of a different specialty than the practitioner who performed the procedure, within the 090-day global period of the procedure(s), once per 090-day global period, when there has not been a formal transfer of care and requires the following required elements, when possible and applicable:

Reading available surgical note to understand the relative success of the procedure, the anatomy that was affected, and potential complications that could have arisen due to the unique circumstances of the patient's operation.
Research the procedure to determine expected post-operative course and potential complications (in the case of doing a post-op for a procedure outside the specialty).
Evaluate and physically examine the patient to determine whether the post-operative course is progressing appropriately.
Communicate with the practitioner who performed the procedure if any questions or concerns arise. (List separately in addition to office/outpatient evaluation and management visit, new or established)).

We are proposing that HCPCS code GPOC1 would be reported by a physician or other practitioner who did not perform the surgical procedure for a global package and provides related post-operative visits during the global period despite the absence of a formal transfer of care. We are proposing that the add-on code (HCPCS code GPOC1) would only be reported with an office or other outpatient E/M visit for the evaluation and management of a new or established patient. We would expect the documentation in the medical record to indicate the relevant surgical procedure, to the extent the billing practitioner can readily identify it, in order to aid in our understanding of the post-operative care being furnished and when there is no transfer of care modifier appended on the claim.

We are proposing that this code could be billed only once during the 90-day global period for the global package because we believe the practitioner would only have additional resource costs upon the first visit following the procedure. We are proposing to assign a ZZZ global period payment indicator for HCPCS code GPOC1, as this allows the add-on code to be billed during the post-operative time frame that applies to payment for each surgical procedure and, under our proposed policy, this code would be reportable with an E/M visit. The ZZZ global period payment indicator would identify this code as a service that is related to another service paid under the PFS and is always included in the global period of the other service.

We note that the proposed valuation of HCPCS code GPOC1 is meant to capture the additional resource costs, including for visit complexity inherent to office/outpatient care associated with a post-operative visit that is not accounted for in the appropriate office/outpatient E/M base code billed by the physician or practitioner. Therefore, we believe that CPT code 90785 (Interactive complexity (List separately in addition to the code for primary procedure)) serves as an appropriate reference for the purposes of valuing HCPCS code GPOC1. CPT code 90785 was created to capture additional work that occurs during diagnostic psychiatric evaluation, psychotherapy, psychotherapy performed with an E/M service and group psychotherapy sessions, and the service refers to specific communication factors that complicate the delivery of a psychiatric/psychotherapy procedure. However, we believe there may be relatively less work involved for GPOC1 when compared to the work of CPT code 90785, considering the amount of time needed to gather the operative history and conduct the elements discussed above. Therefore, we are proposing a work RVU of 0.16, which represents approximately half of the assigned work for minutes of CPT code 90785. Additionally, we are proposing a work time of 5.5 minutes (or half of the 11 minutes established for CPT code 90785), personally performed by the billing practitioner including the elements discussed above during the post-operative E/M visit furnished during the global period, that is, no later than 90-days following a 90-day global code, respectively. CPT code 90785 has no direct PE inputs, and we are proposing the same for HCPCS code GPOC1.

To help inform whether our proposed valuation reflects the typical service, we are seeking comment the typical time and intensity physicians and practitioners spend over and above a separately billed E/M visit when providing post-operative care to a patient when they did not perform the surgical procedure, gathering the surgical history as well as the pre-operative, intra-operative, and post-operative, and on the proposed service elements and the relative intensity compared to similar service elements of other CPT codes. For the individual practitioner, not having an intimate knowledge of the procedure itself and not having a before/after comparison to look at for the wound can all complicate Start Printed Page 61736 their E/M visit. The proposed work RVUs are intended to account for the additional relative resource costs in time and intensity in addition to those involved in the E/M visit.

Finally, we recognize that historically, the CPT Editorial Panel has frequently created CPT codes describing services for which we originally established G-codes and adopted them through the CPT Editorial Panel process. We note that we would consider using any newly available CPT coding to describe services similar to those described here in future rulemaking.

For discussion of our expected utilization assumptions for this service, see the discussion in the Regulatory Impact Analysis section of this proposed rule.

In the CY 2024 PFS final rule, we finalized our proposal to allow remote therapeutic monitoring (RTM) services to be furnished by occupational therapy assistants (OTAs) and physical therapy assistants (PTAs) under the general supervision of occupational therapists (OTs) and physical therapists (PTs) in private practice, in an effort to align with the general supervision policy for these services for physicians and other practitioners described in the CY 2023 final rule ( 88 FR 78990 ). We also noted that we would consider for possible future rulemaking the commenters' responses to our request for information (RFI) on changing the supervision of therapy assistants in the private practice setting to general supervision for all therapy services ( 88 FR 78990 through 78992 ).

In the CY 2024 PFS proposed rule, we reviewed the statutory provisions at sections 1861(p) and 1861(g) (by cross-reference to section 1861(p)) of the Act that describe outpatient physical therapy and occupational therapy services furnished to individuals by physical therapists (PTs) and occupational therapists (OTs) meeting licensing and other standards prescribed by the Secretary if the services meet the necessary conditions for health and safety. These statutory provisions refer separately to outpatient therapy services furnished by a provider of services (such as a rehabilitation agency) and those services furnished in the therapist's office or the individual's home, thus distinguishing therapists who work for an institutional provider of therapy services from therapists who furnish and bill independently for these outpatient therapy services ( 88 FR 52358 through 52359 ). In regulations, we have addressed these therapists as physical or occupational therapists in private practice (PTPPs and OTPPs) ( 63 FR 58868 through 58870 ). The regulations specific to services furnished by occupational or physical therapists in private practice are found at §§ 410.59(c) and 410.60(c), respectively.

We also summarized a history of related regulatory provisions in the CY 2024 PFS proposed rule. In the CY 2005 PFS final rule with comment period ( 69 FR 66236 , 66351 through 66354 ), we explained that the personnel requirements that are applicable for Home Health Agencies (HHAs) at 42 CFR part 484 for therapists, therapy assistants and speech-language pathologists (SLPs) apply to all outpatient physical therapy, occupational therapy, and speech-language pathology services. In the CY 2005 PFS final rule, we also added a basic rule at §§ 410.59(a) and 410.60(a), respectively, by cross-referencing the qualifications for OTs and their OTAs and PTs and their PTAs for all occupational therapy and physical therapy services, respectively, including those who work in private practices, to 42 CFR part 484 . Later, in the CY 2008 PFS final rule ( 72 FR 66328 through 66332 ), we updated the qualification standards at 42 CFR part 484 for OTs, OTAs, PTs, PTAs, and SLPs.

In the CY 2024 PFS proposed rule, through our RFI on general supervision of OTAs and PTAs by OTPPs and PTPPs, respectively, we solicited public comment, along with supporting data, for our consideration for possible future rulemaking about the following: (a) the questions and concerns we highlighted related to access, patient safety, and utilization; (b) revising §§ 410.59(a)(3)(ii) and (c)(2) and 410.60(a)(3)(ii) and (c)(2) to permit general supervision of OTAs and PTAs by the OTPP and PTPP, respectively, when furnishing therapy services; and (c) any appropriate exceptions to allowing general supervision in the furnishing of therapy services ( 88 FR 52358 through 52359 ).

In the CY 2024 PFS final rule, we reviewed the comments we received in response to the proposed rule (please refer to ( 88 FR 78990 through 78992 )). We noted that we would consider these comments for possible future rulemaking—see our review of comments on the RFI in the CY 2024 PFS final rule ( 88 FR 78992 ).

Over the past several years and again more recently, we have heard from interested parties that the direct supervision requirements in the private practice setting are problematic for OTPPs and PTPPs who must remain on-site and immediately available when Medicare patients are treated in order to bill for therapy services furnished by their supervised OTAs and PTAs. As a remedy to this situation, interested parties have requested that we revise our requirement for PTPPs and OTPPs to provide direct supervision of OTAs and PTAs to align with the general supervision policies for OTs and PTs that work in Medicare institutional settings that provide therapy services (for example, rehabilitation agencies, outpatient hospitals, SNFs and comprehensive outpatient rehabilitation facilities (CORFs), etc.), to allow for the general supervision of their therapy assistants. These interested parties tell us that their respective State laws and policies allow general supervision of therapy assistants (most often requiring the OT or PT to be in touch with their therapy assistants via telecommunication) in at least 44 States for PTAs, [ 136 ] and all but one State for OTAs.

Some interested parties have reported that allowing for general supervision of OTAs and PTAs by OTPPs and PTPPs, respectively, would allow for patients to have increased access to outpatient therapy services, even with ongoing healthcare workforce shortages. The shortages of OTs [ 137 ] and OTAs, [ 138 ] PTs, [ 139 ] and PTAs, [ 140 ] are noted by the United States Bureau of Labor Statistics, which shows thousands of open positions in all of these fields. Interested parties noted that over 22,000 PTs left the workforce in 2021. [ 141 ] Additionally, Start Printed Page 61737 these interested parties noted that workforce shortages have greater impact on private practices in rural and underserved areas where hourly wages are lower, and the OTPPs and PTPPs in these areas tend to have small practices. The interested parties stated that Medicare's direct supervision policy, which requires the PTPP and the PTA to both be present when a Medicare patient is treated, does not allow small practices with one PT and one or two PTAs, for example, to work different or overlapping schedules in order to accommodate all patients' availability by allowing the OTA/PTA to work before or after the OTPP/PTPP normal hours. The interested parties also stated that the direct supervision requirement can unfairly delay care for Medicare patients when, for example, a PTPP or OTPP is out sick, the practice does not have alternative coverage, and appointments for Medicare patients must be canceled.

In light of this input, we believe that the direct supervision requirement for OTPPs and PTPPs of OTAs and PTAs, respectively, may have had an unintended consequence of limiting access to needed therapy services. As noted by interested parties, both the OTPP/PTPP and their respective OTA/PTA must be present in the office in order to bill and receive Medicare payment for therapy services furnished by OTAs and PTAs. This means, for example, that an OTPP/PTPP cannot bill and receive payment for therapy services furnished to a Medicare patient in their home when furnished by an OTA/PTA, without the presence of the OTPP/PTPP. The direct supervision requirement for OTAs and PTAs in the private practice setting is more stringent than the supervision requirements for OTAs and PTAs in institutional settings. For example, as we noted in the CY 2024 PFS proposed rule, 42 CFR 485.713 specifies that when an OTA or PTA provides services at a location that is off the premises of a clinic, rehabilitation agency, or public health agency, those services are supervised by a qualified occupational or physical therapist who makes an onsite supervisory visit at least once every 30 days. We also cited Table 4 in our Report to Congress, titled “Standards for Supervision of PTAs and the Effects of Eliminating the Personal PTA Supervision Requirement on the Financial Caps for Medicare Therapy Services,” [ 142 ] in the CY 2024 PFS proposed rule to demonstrate that the minimum level of supervision by PTs and OTs for services performed by PTAs and OTAs working in institutional settings is a general level of supervision, in accordance with various regulations ( 88 FR 52359 ). Therefore, we believe that a change from direct to general supervision would allow OTPPs and PTPPs the flexibility to better accommodate patients' availability and act to ensure access to necessary therapy services. A change from direct to general supervision would also allow OTPPs and PTPPs to bill and receive Medicare payment for therapy services furnished by their OTAs and PTAs when they are not in the office or patient's home at the same time.

We also believe that it is important to better align our supervision policies for OTPPs and PTPPs with the majority of state-established supervision levels for therapy assistants providing occupational therapy and physical therapy services. We note that the majority of states allow OTs and PTs to provide general supervision of their respective OTAs and PTAs when furnishing occupational therapy and physical therapy services. We believe that States are well aware of the health and safety needs for their residents who receive therapy services from OTs and their supervised OTAs, and PTs and their supervised PTAs. Given these beliefs and the input from interested parties, we are proposing to revise our regulations at §§ 410.59(a)(3)(ii) and (c)(2) and 410.60(a)(3)(ii) and (c)(2) to allow for general supervision of OTAs and PTAs by OTPPs and PTPPs, when the OTAs and PTAs are furnishing outpatient occupational and physical therapy services, respectively. We expect that this proposal would both increase access to therapy services and more closely align Medicare policy with the majority of State practice acts for occupational therapy and physical therapy. This will parallel the 44 States that allow general supervision of PTAs and the 49 States that allow general supervision of OTAs (most often described as requiring the PT or OT to be in touch via telecommunication). For the States with more restrictive supervision levels, such as direct supervision, those therapy services are always furnished to the extent that is permitted under State law. We note that while we are proposing to allow for general supervision by OTPPs and PTPPs of their OTAs/PTAs, an OTPP or PTPP would still be required to provide direct supervision to unenrolled OTs and PTs, respectively, in accordance with §§ 410.59(c)(2) and 410.60(c)(2).

We are soliciting comment on our proposals.

Sections 1861(p), (g), and (ll)(2) of the Act require that an individual outpatient is under the care of a physician and for whom a plan for the physical therapy, occupational therapy, or speech-language pathology services that are to be furnished has been established by a physician or by a qualified PT, OT, or SLP and is periodically reviewed by a physician. Sections 1835(a)(2)(C) and 1835(a)(2)(D) of the Act require that payment for Medicare therapy services may be made for outpatient physical therapy, occupational therapy, and speech-language pathology services only if a physician certifies (and recertifies, where such services are furnished over a period of time) that: (a) the services are or were required because the patient needs or needed therapy services; (b) a plan for furnishing such services was established by a physician or qualified therapist providing such services, and is periodically reviewed by the physician; and (c) the services are or were furnished while the individual was under the care of a physician.

In accordance with the statute and § 424.24(b), Medicare Part B pays for outpatient physical therapy and speech-language pathology services furnished by providers only if a physician certifies the content specified in § 424.24(c)(1) or (4). We recognize that it may not be clear that § 424.24(c) applies to the occupational therapy services furnished by providers, since occupational therapy services are currently only explicitly mentioned in the recertification requirements at § 424.24(c)(4).

We note that there are multiple references to § 424.24(c) in the Medicare Benefit Policy Manual, Pub. 100-02, chapter 15, sections 220.1—Conditions of Coverage and Payment for Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services, 220.1.2—Plans of Care for Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services, and 220.1.3—Certification and Recertification of Need for Treatment and Therapy Plans of Care, which convey our current policy that all outpatient physical therapy, occupational therapy, and speech- Start Printed Page 61738 language pathology services are subject to requirements for certification and recertification at § 424.24, whether furnished by providers or by suppliers such as therapists in private practice (TPPs). We note that while section 1835 of the Act explicitly refers to services furnished by providers of services, which would include hospitals and other institutional providers as defined in section 1861(u) of the Act, and clinics, rehabilitation agencies, or public health agencies as further described in section 1835(a) of the Act, we have interpreted the requirements of section 1835(a)(2)(C) and 1835(a)(2)(D) as applying to therapy services furnished by both providers and suppliers. See Medicare Benefit Policy Manual, Pub. 100-02, chapter 15, sections 220.1, 220.1.2, and 220.1.3. We believe that this interpretation is based on the certification and recertification requirements under section 1835(a) of the Act as a way to effectuate the requirement in sections 1861(p), (g), and (ll)(2) of the Act that the patient is under the care of a physician, and that the plan of treatment/care for the physical therapy, occupational therapy, or speech-language pathology services has been established by a physician or by a qualified PT, OT, or SLP and is periodically reviewed by a physician. Additionally, we thought it was important to establish conforming policies for these therapy services in both the outpatient provider and private practice settings.

Due to the foregoing concerns, we are proposing to revise the headings of paragraphs (c) introductory text and (c)(1)(i) to include the term “occupational therapy” after physical therapy. We propose to replace the term speech pathology with the accepted term speech-language pathology in 42 CFR 424.24(c)(1)(i) . We are also proposing to add the term “occupational therapist” to 42 CFR 424.24(c)(3)(ii) between physical therapist and speech-language pathologist.

The regulations at 42 CFR 424.24(c) require that a physician, nurse practitioner (NP), physician assistant (PA), or clinical nurse specialist (CNS) who has knowledge of the case sign the initial certification for the patient's plan of treatment. We remind readers that plan of treatment is synonymous with the “plan of care” mentioned above. This terminology appears in several sections of Pub. 100-02, chapter 15, and both terms may be used interchangeably. In accordance with § 424.24(c)(2), the initial certification must be obtained as soon as possible after the plan is established by a PT, OT, or SLP. In Pub. 100-02, chapter 15, section 220.1.3 for Certification and Recertification of Need for Treatment and Therapy Plans of Care, we specify that the physician or nonphysician practitioner (NPP) must sign the initial plan of care (POC) with a dated signature or verbal order within 30 days from the first day of treatment, including evaluation (or 14 days if a verbal order), in order for the PT, OT, or SLP to be paid for the services. For this reason, the manual also states that the therapist should forward the treatment plan to the physician/NPP as soon as it is established rather than waiting to do so. The manual allows for a delayed certification when the physician or NPP completes certification and includes a reason for the delay, and delayed certifications are accepted without justification up to 30 days after the due date.

The regulations at § 424.24(c)(4) require recertification at least every 90 days, and the plan or other documentation in the patient's medical record must indicate the continuing need for physical therapy, occupational therapy, or speech-language pathology services. The physician, nurse practitioner, clinical nurse specialist, or physician assistant who reviews the plan must recertify the plan by signing the medical record. Pub. 100-02, chapter 15, section 220.1.4.C clarifies that payment and coverage conditions require that the plan of care be reviewed as often as necessary but at least whenever it is certified or recertified, in order to meet the certification requirements. We explained in the CY 2008 PFS final rule, when changing the plan of care recertification interval from 30 to 90 days, this was done in order to allow more flexibility to the physician/NPP to order the appropriate amount of therapy for each patient's needs ( 72 FR 66333 ). Thus, a physician or non-physician practitioner (NPP) may certify or recertify a plan of care at an interval the physician or NPP determines is appropriate, as long as the amount of time between each recertification does not exceed 90 calendar days. As many episodes of therapy treatment are completed in less than 30 calendar days, we expect that physicians and NPPs will continue to certify plans of care that appropriately estimate the duration of needed therapy treatment for a patient, even if the duration is less than 90 days.

Over the past two years, representatives of several therapy-related organizations have requested that CMS reduce the administrative burden involved with attempting to obtain signed plans of treatment from the physician/NPP. They expressed concern that therapists are held accountable for the action or inaction of physicians/NPPs who may be overwhelmed with paperwork. These interested parties report that therapists make exhaustive efforts to obtain the physician/NPP's signature—some reporting that they contact physician offices (via phone, email, or fax, etc.) more than 30 times. Without the required signature, the therapist will not meet the conditions to be paid for the services they deliver. These interested parties recommend that payment for therapy services should be determined by the medical necessity of the service and whether the therapist has met their statutory and regulatory requirements. Some of these interested parties have noted that Pub. 100-02, chapter 15, section 220.1.1, states that the physician/NPP order provides evidence that the patient is under the care of a physician and that the services are medically necessary. Interested parties told us that while CMS allows treatment to begin before the physician's/NPP's signature is obtained, PTs, OTs, and SLPs in private practice do so at their own risk, knowing that they might not be paid for the services if the physician's office does not send back the signed plan of treatment. Accordingly, such interested parties have said that care is delayed while awaiting a physician's signature, which could place the beneficiary's health at risk due to the delay in obtaining outpatient therapy services.

While we do not require an order or referral for a Medicare patient to see a PT, OT, or SLP, we have explained that the presence of a signed order from the treating physician satisfies statutory requirements that therapy is/was medically necessary and the patient is/was under the care of a physician (Pub. 100-02, chapter 15, section 220.1.1). However, with this order documented in the medical record, after the therapist evaluates the patient and establishes the plan of treatment, based on the evaluation's findings, the therapist forwards the patient's plan of treatment back to the referring physician/NPP to obtain a dated signature for the same patient with the same diagnosis to meet coverage and payment conditions to satisfy the initial certification requirement—creating an administrative burden for both the physician/NPP and the therapist. Interested parties have reported to us that most patients seeking outpatient therapy services have written orders from their physician, not to be confused with a written plan of treatment. These interested parties have suggested that we amend the regulation Start Printed Page 61739 at § 424.24(c) to permit the presumption of a physician/NPP signature for purposes of certification and recertification in cases where a signed written order or referral from the patient's physician/NPP is on file and there is written documentation in the patient's medical record to substantiate the method and date (such as a fax, email, etc.) that the therapist forwarded the plan of care to the physician/NPP.

Additionally, interested parties representing all therapy disciplines requested that CMS allot time for plan of treatment changes. Interested parties requested that when a physician/NPP orders the therapy services, the physician/NPP be allotted ten business days to modify the plan of treatment by contacting the therapist directly after receiving it from the therapist. For patients without a physician/NPP order, interested parties requested that physician/NPPs be given 30 days after receipt of the plan of treatment to modify the treatment plan.

After reviewing our current regulatory requirements and considering the suggestions of interested parties, we believe it would be appropriate to propose to amend the regulation at § 424.24(c) for those cases when a patient has a signed and dated order/referral from a physician/NPP for outpatient therapy services. Since our policy has been to accept the physician or NPP's signature on the plan of treatment to be their certification of the treatment plan's conditions in the content requirements of § 424.24(c)(1)—that the patient needs or needed physical therapy, occupational therapy or speech-language pathology services, the services were furnished while the individual was under the care of a physician, NP, PA, or CNS, and the services were furnished under a plan of treatment that meets the requirements of § 410.61—we propose that a signed and dated order/referral from a physician/NPP combined with documentation of such order/referral in the patient's medical record along with further evidence in the medical record that the therapy plan of treatment was transmitted/submitted to the ordering/referring physician or NPP is sufficient to demonstrate the physician or NPP's certification of these required conditions. Rather than characterizing this proposal as a “presumption,” we are taking the view that when the patient's medical record includes a signed and dated written order or referral indicating the type of therapy needed, CMS (and our contractors) would treat the signature on the order or referral as equivalent to a signature on the plan of treatment. We believe our proposal would be reflective of the intent of the ordering/referring physician/NPP when that order/referral is on file in the patient's medical record. We further believe that this would still be consistent with the initial certification required under section 1835(a) of the Act for providers of therapy services and our current policy for therapy in the private practice setting. When the ordering/referring physician writes the referral for the type of therapy services they determine their patient needs or needed, they also review the treatment plan the therapist established at the time it is forwarded to them, and they verify that the services are or were furnished while the patient is or was under their care. As such, we propose to carve out an exception to the physician signature requirement at § 424.24(c) by adding a new paragraph (c)(5). The proposed policy would be an exception to the physician signature requirement for purposes of an initial certification in cases where a signed and dated order/referral from a physician, NP, PA, or CNS is on file and the therapist has documented evidence that the plan of treatment has been delivered to the physician, NP, PA, or CNS within 30 days of completion of the initial evaluation. However, at this time, we are not proposing and do not intend to establish an exception to the signature requirement for purposes of recertification of the therapy plan of treatment. We believe that physicians and NPPs should still be required to sign a patient's medical record to recertify their therapy treatment plans, in accordance with § 424.24(c)(4), to ensure that a patient does not receive unlimited therapy services without a treatment plan signed and dated by the patient's physician/NPP.

Under our proposal, CMS or its contractors would be able to treat the physician/NPP signature on the order or referral as equivalent to a signature on the plan of treatment for purposes of the initial certification if that physician/NPP has not signed and returned the patient's plan of treatment to the therapist within 30 days of the initial evaluation, but only in cases where the patient's physician/NPP has signed and dated the written order or referral and indicated the type of therapy needed, and that written order or referral is on file in the medical record. This proposed policy would not affect a contractor's ability or authority to determine whether therapy services are reasonable and necessary for a given beneficiary. Lastly, because there is no requirement for a physician/NPP order or referral for patients to obtain outpatient therapy services, we propose to make clear in proposed § 424.24(c)(5) that the references to an order or referral in § 424.24(c)(5) shall not be construed to require an order or referral for outpatient physical therapy, occupational therapy, or speech-language pathology services. We welcome comments on this proposal.

In addition, we are soliciting comments to gather more information about the need for a regulation that would address the amount of time for changes to plans of treatment. Our regulations at 42 CFR 410.61(d) , which are further clarified in our manual provisions in Pub. 100-02, chapter 15, section 220.1.2.C, currently allow for changes to the treatment plan by the physician/NPP without time restrictions. Interested parties have suggested that CMS allow physicians/NPPs to have just ten business days from the date of receipt of a plan of care to modify that plan of care (in the case of a patient with an order for the therapy services). Additionally, we are also soliciting comment as to whether there should be a 90 calendar day time limit on the order/referral for outpatient therapy services in cases where the order/referral is intended to be used in relation to the proposed regulatory amendment for the initial certification of the treatment plan at § 424.24(c)(5) discussed above—that 90-day limit would span from the order/referral date until the initial treatment of the patient, including the evaluation furnished by the PT, OT, or SLP. We also seek feedback about whether this limit, or one of a different duration, should be incorporated into the regulatory provision we proposed above for § 424.24(c)(5).

We want to clarify that we are not proposing to amend § 424.27 for CORF physical therapy, occupational therapy, and speech-language pathology treatment plans to align with our proposed amendments at § 424.24 because section 1861(cc) of the Act and regulation at 42 CFR 410.105(c) require these treatment plans to be established by a physician.

We are soliciting comments on these proposals and comment solicitations.

The KX modifier thresholds were established through section 50202 of the Bipartisan Budget Act of 2018 ( Pub. L. 115-123 , February 9, 2018) (BBA) and were formerly referred to as the therapy cap amounts. These per-beneficiary amounts under section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) ( Pub. L. 105-33 , August 5, 1997) are updated Start Printed Page 61740 each year based on the percentage increase in the Medicare Economic Index (MEI). Specifically, these amounts are calculated by updating the previous year's amount by the percentage increase in the MEI for the upcoming calendar year and rounding to the nearest $10.00. Thus, for CY 2025, we propose to increase the CY 2024 KX modifier threshold amount by the most recent forecast of the 2017-based MEI. For CY 2025, the proposed MEI increase is estimated to be 3.6 percent and is based on the expected historical percentage increase of the 2017-based MEI. Multiplying the CY 2024 KX modifier threshold amount of $2,330 by the proposed CY 2025 percentage increase in the MEI of 3.6 percent ($2,330 × 1.036) and rounding to the nearest $10.00 results in a proposed CY 2025 KX modifier threshold amount of $2,410 for physical therapy and speech-language pathology services combined and $2,410 for occupational therapy services. We propose to update the MEI increase for CY 2025 based on historical data through the second quarter of 2024, and we would use such data, if appropriate, to determine the final MEI percentage increase and the CY 2025 KX modifier threshold amounts in the CY 2025 PFS final rule.

Section 1833(g)(7)(B) of the Act describes the targeted medical review (MR) process for services of physical therapy, speech-language pathology, and occupational therapy services. The threshold for targeted MR is $3,000 through CY 2027. Effective beginning with CY 2028, the MR threshold levels would be annually updated by the percentage increase in the MEI, per section 1833(g)(7)(B) of the Act. Consequently, for CY 2025, the MR threshold is $3,000 for physical therapy and speech-language pathology services combined and $3,000 for occupational therapy services. Section 1833(g)(5)(E) of the Act states that CMS shall identify and conduct targeted medical review using factors that may include the following:

(1) The therapy provider has had a high claims denial percentage for therapy services under this part or is less compliant with applicable requirements under this title.

(2) The therapy provider has a billing pattern for therapy services under this part that is aberrant compared to peers or otherwise has questionable billing practices for such services, such as billing medically unlikely units of services in a day.

(3) The therapy provider is newly enrolled under this title or has not previously furnished therapy services under this part.

(4) The services are furnished to treat a type of medical condition.

(5) The therapy provider is part of a group that includes another therapy provider identified using the factors described previously in this section.

We track each beneficiary's incurred expenses for therapy services annually and count them towards the KX modifier and MR thresholds by applying the PFS rate for each service less any applicable MPPR amount for services of CMS-designated “always therapy” services (see the CY 2011 PFS final rule at 75 FR 73236 ). We also track therapy services furnished by critical access hospitals (CAHs), applying the same PFS-rate accrual process, even though they are not paid for their therapy services under the PFS and may be paid on a cost basis (effective January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through 74410 ).

When the beneficiary's incurred expenses for the year for outpatient therapy services exceed one or both of the KX modifier thresholds, therapy suppliers and providers use the KX modifier on claims for subsequent medically necessary services. Using the KX modifier, the therapist and therapy provider attest that the services above the KX modifier thresholds are reasonable and necessary and that documentation of the medical necessity for the services is in the beneficiary's medical record. Claims for outpatient therapy services exceeding the KX modifier thresholds without the KX modifier included are denied.

In the CY 2024 PFS proposed rule, we sought comment on whether there is a need for potential separate coding and payment for interventions initiated or furnished in the emergency department (ED) or other crisis settings for patients with suicidality or at risk of suicide, such as safety planning interventions and/or telephonic post-discharge follow-up contacts after an emergency department visit or crisis encounter, or whether existing payment mechanisms are sufficient to support furnishing such interventions when indicated. Several commenters encouraged CMS to enable wider implementation under Medicare of the Safety Planning Intervention (SPI) and the Post-Discharge Telephonic Follow-up Contacts Intervention (FCI) and expressed that the current payment mechanisms are not sufficient, noting that the lack of adequate payment mechanisms and suitable billing codes for these interventions are barriers that are essential to address. The commenters noted that EDs are not the only care setting where there is need and opportunity to enhance suicide prevention, but that elevated suicide risk is particularly prevalent among ED patients. One commenter noted that a designated code for SPI would make it significantly easier to document that SPI was furnished, including in quality reporting and value-based payment programs.

More than 49,000 people died by suicide in 2022 and death by suicide is growing significantly in older adults, who comprise most of the Medicare population. We recognize data showing that suicide by intentional overdose is a growing concern, particularly among young people, older people, and Black women, although researchers acknowledge the complexities of distinguishing intentional from unintentional death. [ 143 ]

Safety planning interventions involve a patient working with a clinician to develop a personalized list of coping strategies and sources of support that the person can use in the event of experiencing thoughts of harm to themselves or others. This is not a suicide risk assessment, but rather, an intervention provided to people determined to have elevated risk. Safety planning interventions have also been used to reduce the risk of overdose. The basic components of a safety plan include the following: (1) recognizing warning signs of an impending suicidal crisis or actions that increase the risk of suicide; (2) employing internal coping strategies; (3) utilizing social contacts and social settings as a means of distraction from suicidal thoughts and/or taking steps to reduce the risk of suicide; (4) utilizing family members, significant others, caregivers, and/or friends to help resolve the crisis; (5) contacting mental health professionals, crisis services, or agencies; and (6) making the environment safe, including restricting access to lethal means, as applicable. [ 144 ] One important aspect of making an environment safe could be, Start Printed Page 61741 for example, addressing a person's access to lethal means, such as firearms.

We understand that safety planning is consistent with current practice standards and that many hospitals and clinicians in other settings are already providing some or all of these services to the people who need them, including through the Department of Veterans Affairs (VA). [ 145 ] [ 146 ] However, in one survey of EDs, only 15.3 percent could confirm routinely implementing safety planning with all of the structured elements mentioned above. Provision of individual safety planning elements ranged from 24.8 percent (n = 492) to 79.2 percent (n = 1710), with 2 of 6 elements being routinely provided more than 50 percent of the time: lists of professionals or agencies to contact in a crisis (1710 [79.2 percent]) and helping patients to recognize warning signs of suicide (1075 [52.2 percent]). [ 147 ] Suicide risk among people with substance use disorders who also are at high risk for or may have experienced an intentional overdose is not well recognized. [ 148 ]

Therefore, we are proposing to establish separate coding and payment under the PFS describing safety planning interventions. Specifically, we are proposing to create an add-on G-code that would be billed along with an E/M visit or psychotherapy when safety planning interventions are personally performed by the billing practitioner in a variety of settings. We recognize that training and expertise are needed to perform these interventions safely and appropriately and are seeking comment regarding whether clinical staff who meet the definition of auxiliary personnel defined at 42 CFR 410.26(a)(1) or who are employed by a hospital could participate in furnishing this service under the supervision of the billing practitioner in certain settings with the relevant training needed to perform the service as well as what sort of training would be needed.

The proposed G-code is HCPCS code GSPI1: Safety planning interventions, including assisting the patient in the identification of the following personalized elements of a safety plan: recognizing warning signs of an impending suicidal crisis; employing internal coping strategies; utilizing social contacts and social settings as a means of distraction from suicidal thoughts; utilizing family members, significant others, caregivers, and/or friends to help resolve the crisis; contacting mental health professionals or agencies; and making the environment safe; (List separately in addition to an E/M visit or psychotherapy). We welcome comments on the proposed elements of the safety planning code.

We are proposing to value HCPCS code GSPI1 based on the valuation for CPT code 90839 ( Psychotherapy for crisis ), which describes 60 minutes, and which we believe describes a similar level of intensity as HCPCS code GSPI1. For HCPCS code GSPI1, we are assuming a typical time of 20 minutes, resulting in a proposed work RVU of 1.09 (based on one third of the work value currently assigned to CPT code 90839, which is 3.28). We welcome comments on whether 20 minutes accurately captures the typical amount of time spent with a patient on safety planning interventions, including all six elements enumerated in this section. Additionally, we welcome comments on whether these interventions typically occur in the context of an encounter, such as an E/M visit or psychotherapy, or whether there may be times when they may be furnished as a standalone service and whether we should consider allowing this code to be billed on its own. We also welcome comments regarding which clinician types might be most likely to bill such a code on its own.

Some research suggests that patients seen in the ED with deliberate self-harm, intentional overdose, and/or suicidal ideation have been associated with substantially increased risk of suicide and other mortality during the year following their visit to the ED. [ 149 ] FCI is a specific protocol of services for individuals with suicide risk involving a series of telephone contacts between a provider and patient in the weeks and sometimes months following discharge from the emergency department and other relevant care settings, that occurs when the person is in the community and is designed to reduce the risk for subsequent adverse outcomes. FCI calls are typically 10-20 minutes in duration and aim to encourage use of the Safety Plan (as needed in a crisis) and updating it to optimize effectiveness, expressing psychosocial support, and helping to facilitate engagement in any indicated follow-up care and services. We note that this service would not be within the scope of Medicare telehealth services and not subject to the restrictions described in Section 1834(m) because these services are specifically structured to be delivered via audio-only phone calls and are not a substitute for an in-person service.

In a recent study led by the Joint Commission, which surveyed a national sample of hospitals to assess the prevalence of SPI and several other recommended suicide prevention services, fewer than half of responding hospitals reported furnishing any post-discharge follow-up contacts. Of these, only 33 percent (16 percent of responding hospitals overall) reported reaching discharged patients “most of the time.” Further, among hospitals that furnish follow-up contacts, fewer than half reported covering any of the main aims of FCI, for example, 41 percent review the Safety Plan, 49 percent provide psychosocial support, and 38 percent facilitate outpatient care. [ 150 ]

However, some studies have demonstrated that SPI and other services may be able to reduce suicidal behaviors. For example, in the ED-SAFE trial for emergency department (ED) patients identified with elevated suicide risk, the intervention included SPI and up to seven post-discharge follow-up calls with the patient “focused on identifying suicide risk factors, clarifying values and goals, safety and future planning, facilitating treatment engagement/adherence, and facilitating patient-significant other problem-solving.” [ 151 ] In the SAFE VET study [ 152 ] of ED patients identified with elevated suicide risk, the intervention included SPI and at least two follow-up calls with patients “to monitor suicide risk, review and revise the SPI, and Start Printed Page 61742 support treatment engagement.” [ 153 ] Each of these studies reported significantly lower suicide behaviors—attempts and/or deaths—among intervention patients compared to the respective control conditions.

In light of this, we are proposing to create a monthly billing code to describe the specific protocols involved in furnishing post-discharge follow-up contacts that are performed in conjunction with a discharge from the emergency department for a crisis encounter, as a bundled service describing four calls in a month, each lasting between 10-20 minutes. The proposed G-code is HCPCS code GFCI1: Post discharge telephonic follow-up contacts performed in conjunction with a discharge from the emergency department for behavioral health or other crisis encounter, per calendar month. We seek comment on whether we should consider finalizing a specified duration that HCPCS code GFCI1 could be billed) following discharge, for example, allowing this code to be billed for up to two months following discharge or whether a longer duration would be appropriate, the number of calls per month, the billing structure (for example, four calls for each discharged patient), and any other relevant feedback.

We are proposing to price this service based on a direct crosswalk to CPT code 99426 ( Principal care management; first 30 minutes of clinical staff time directed by a physician or other qualified healthcare professional ), which is assigned a work value of 1.00 work RVUs. Since CPT code 99426 describes care management for a single condition, we believe the work would be similar in nature and intensity. We note that under this proposal, proposed HCPCS code GFCI1 could be billed regardless of whether proposed HCPCS code GSPI1 was also furnished and billed for the same patient. We propose that the billing practitioner would need to meet a threshold of at least one real-time telephone interaction with the patient in order to bill HCPCS code GFCI1, and that unsuccessful attempts to reach the patient would not qualify as a real-time telephone interaction. We welcome comments on this proposed threshold to bill HCPCS code GFCI1, recognizing that while practitioners may attempt to reach the patient, there may be times when the patient cannot be reached. We are also proposing that the billing practitioner could not count time or effort more than once for the purposes of billing this code and another service.

Additionally, as we recognize that behavioral health practitioners, training programs, and institutions have worked conscientiously to have risk assessment and safety planning for high-risk patients integrated into their workflows for many years and that discharge instructions and after visit planning may represent one of many final products from the synthesis of all the steps involved in these encounters, we note that we do not intend to unnecessarily disaggregate aspects of streamlined clinical workflows that providers are successfully using to treat high risk patients. Moreover, we also recognize that practitioners may currently be billing for safety planning activities using existing coding, such as E/M visits, psychotherapy, and crisis management codes or potentially for follow-up calls using existing care management services. However, to the extent that this intervention is part of the standard of care, we believe that Medicare payment should accurately reflect the additional resource costs involved in furnishing this service.

Lastly, as applicable Part B cost sharing would apply for HCPCS code GFCI1, we are proposing to require the treating practitioner to obtain verbal (or written) beneficiary consent in advance of furnishing the services described by GFCI1, which would be documented by the treating practitioner in the medical record, similar to the conditions of payment associated with care management and other non-face-to-face services paid under the PFS. We note that under this proposal, obtaining advance consent would include: (1) ensuring that the patient is aware that Medicare cost sharing applies to these services; (2) furnishing and receiving the necessary information to enable the patient to receive these services (for example, obtaining the patient's telephone number(s)); and (3) confirming that the patient consents to the contacts.

We are proposing Medicare payment to billing practitioners for digital mental health treatment (DMHT) devices furnished incident to or integral to professional behavioral health services used in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care. We are refining the digital cognitive behavioral therapy “digital CBT” terminology that we have used previously ( 88 FR 52262 , 52370 through 52371 , 88 FR 78818 , 79012 and 79013 ). We are proposing Medicare payment to billing practitioners for digital mental health treatment (DMHT) devices furnished incident to or integral to professional behavioral health services used in conjunction with ongoing. In this proposed rule we use the term “digital mental health treatment (DMHT) device” to include the term “digital CBT” we used in prior rulemaking and in general to refer to software devices cleared by the Food and Drug Administration (FDA) that are intended to treat or alleviate a mental health condition, in conjunction with ongoing behavioral health care treatment under a behavioral health treatment plan of care, by generating and delivering a mental health treatment intervention that has a demonstrable positive therapeutic impact on a patient's health. We note first that the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM) does not refer to psychiatric disorders but to mental disorders. In this section, following the DSM, we use the term behavioral health conditions and mental disorders interchangeably and to mean psychiatric disorders as referenced in FDA regulation, 21 CFR 882.5801 . Second, we note that FDA guidance refers to computerized behavioral therapy by the acronym CBT. We aim to both provide access to vital behavioral health services and gather further information about the delivery of digital behavioral health therapies, their effectiveness, their adoption by practitioners as complements in the care they furnish, and their use by patients for the treatment of behavioral health conditions. We also recognize that there are certain statutory limitations on payment for products under the broader category of “digital health interventions.” We acknowledge that the field of digital therapeutics is evolving and are open to feedback from the public on this topic, including the CPT Editorial Panel. Additionally, we recognize that historically, the CPT Editorial Panel has frequently created CPT codes describing services that we originally established using G codes and adopted them through the CPT Editorial Panel process. We note that we would consider using any newly available CPT coding to describe services similar to those described here in future rulemaking.

Over the last 5 years the AMA CPT Editorial Panel and CMS have Start Printed Page 61743 developed coding and separate payment for monitoring physiologic status using software enabled devices that capture and record or transmit data that may be reported to and interpreted by practitioners to manage a patient under a specific treatment plan. ( 83 FR 59452 , 59574 ) Medicare payment has long been available for practitioner provision of monitoring equipment and other kinds of devices provided incident to or integral to the practitioner's professional services. Most recently we have finalized payment for devices which record data related to signs, symptoms, and functions of a therapeutic response (typically for use in association with physical or occupational therapy care) ( 86 FR 64996 , 65114-65116 ).

However, technologies that rely primarily on software, licensing, and analysis fees, with minimal costs in equipment and hardware may not have been typical and are not well accounted for in our practice expense (PE) methodology. PE resources involved in furnishing services are characterized as either direct or indirect costs. Direct costs of the PE resources involved in furnishing a service are estimated for each HCPCS code and include clinical labor, medical supplies, and medical equipment. Indirect costs include administrative labor, office expenses, and all other expenses. Indirect PE is allocated to each service based on physician work, direct costs, and a specialty-specific indirect percentage. The source of the specialty specific indirect percentage is the Physician Practice Information Survey (PPIS), last administered in 2007 and 2008, prior to the adoption of digital therapy technologies ( 86 FR 65037 ). Nevertheless, in past rulemaking, we have recognized that in some cases practitioners do incur resource costs for the purchase and ongoing use of software ( 86 FR 65038 ).

In the CY 2023 PFS final rule, we finalized our proposal to accept the RUC recommendation to contractor price CPT code 98978 ( Remote therapeutic monitoring (e.g., therapy adherence, therapy response); device(s) supply with scheduled (e.g., daily) recording(s) and/or programmed alert(s) transmission to monitor cognitive behavior therapy, each 30 days ), a PE-only device code ( 86 FR 69523 , 69646 ). At the time, specialty societies indicated that the technologies for this service are still evolving, and that as a result, there were no invoices for devices specific to the cognitive behavioral therapy monitoring services described by the code that could be shared. There was no professional work associated with the code.

In the CY 2024 PFS proposed rule, we requested information on digital therapeutics for behavioral health. Among many questions, we asked how practitioners determine which patients might be best served by digital therapeutics and how practitioners monitor the effectiveness of prescribed interventions on an ongoing basis once the intervention has begun. We also asked how the treating clinician was involved in the services received. We asked what scientific and clinical evidence of effectiveness CMS should consider when determining whether digital therapeutics for behavioral health, including care for substance use disorders, depression, sleep disorders and other conditions are reasonable and necessary. We asked whether DMHT devices were used as incident to supplies or independent of a patient visit with a practitioner and if practitioners in such cases issued an order for such devices ( 88 FR 52262 , 52370 through 52371 ). These factors related to the nature of this treatment compared to other PFS services pose challenges for fitting DMHT services into the existing benefit structure under the PFS.

Setting appropriate pricing under the PFS has also presented challenges. As noted previously, technologies that rely primarily on software, licensing, and analysis fees, with minimal costs in equipment and hardware are not well accounted for in our practice expense (PE) methodology, even though these items may be appropriately considered practice expenses. Consequently, over the past several years, we have relied on a crosswalk methodology to approximate relative resource costs for these kinds of services relative to other PFS services, or contractor pricing.

Interested parties requested that we adopt coding specifically for DMHT devices, where the digital software device is the actual therapy/intervention (the algorithm software is the DMHT) as opposed to a therapeutic monitoring device that transmits patient data as described by CPT code 98978 for which we finalized contractor pricing in CY 2023. Interested parties have also asked us to set national pricing for the service to supply the DMHT device and education/onboarding that reflects the direct practice expense incurred by practitioners when furnishing DMHT. One of the interested parties submitted invoices to provide data we could use as the basis to set payments for DMHT coding. The interested party submitted four invoices reflecting considerable variation in the cost of the DMHT treatment over 30-day and 90-day periods. There is still more variation in pricing for comparable products that are available for considerably lower prices in various markets, with prices ranging from free to $140 per year, based on an online search ( https://www.carepatron.com/app/cbt-therapy-apps , accessed March 20, 2024).

As the field of innovative products including digital therapeutics and computerized behavioral therapy devices for psychiatric or mental disorders develops and expands, the FDA and Substance Abuse and Mental Health Services Administration (SAMHSA) among other agencies such as the Veterans Health Administration (VHA) are also monitoring the development of the field of digital therapeutic devices, including for behavioral health purposes. For example, VHA is providing digital behavioral health applications as self-help tools, not independent treatment interventions. The FDA has a regulatory framework, discussed below in this section, to classify devices and review computerized behavioral therapy devices for psychiatric disorders.

We recognize that digital therapeutics may offer innovative means to access certain behavioral health care services. The FDA definition of devices encompasses software intended by the manufacturer to be used, alone or in combination for the specific medical purpose of diagnosis, prevention monitoring treatment or alleviation of disease and does not achieve its primary intended action by pharmacological, immunological or metabolic means. [ 154 ] SAMHSA has defined digital therapeutics (DTx) in the behavioral health context as “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient's health.” [ 155 ] SAMHSA also notes that “DTx may be used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.” Given nationwide behavioral health workforce shortages combined with increasing demand for behavioral health care services, some Medicare beneficiaries may have limited Start Printed Page 61744 access to these services. [ 156 ] This proposal encompasses only part of what may be a spectrum of broadly similar products, most of which might require a new statutory Medicare benefit category. Our proposed coding and payment policy only applies to DMHT devices that have been cleared by the FDA. Many digital platforms and applications are marketed as behavioral health and wellness interventions; this proposal does not extend to such platforms and applications in part because other than some DTx, few have evidence demonstrating improved behavioral health outcomes. [ 157 ]

We propose to create three new HCPCS codes for DMHT devices modeled on coding for RTM services. Effective beginning in CY 2025, we propose that physicians and practitioners who are authorized to furnish services for the diagnosis and treatment of mental illness would be able to bill a new HCPCS code: GMBT1 ( Supply of digital mental health treatment device and initial education and onboarding, per course of treatment that augments a behavioral therapy plan ) for furnishing a DMHT device. GMBT1 would be payable only if the DMHT device has been FDA cleared and the billing practitioner is incurring the cost of furnishing the DMHT device to the beneficiary. Furnishing of the DMHT device must be incident to the billing practitioner's professional services in association with ongoing treatment under a plan of care by the billing practitioner. The billing practitioner must diagnose the patient and prescribe or order the DMHT device. The patient could then use the DMHT device at home or perhaps in an office or other outpatient setting, if that is how the device has been cleared by FDA for use under 21 CFR 882.5801 . The DMHT device furnished must have demonstrated a reasonable assurance of safety and effectiveness. The FDA makes a determination of safety and effectiveness under 21 CFR 860.7 . When making this determination, the FDA will consider a variety of factors including users, conditions of use, probable benefit to health weighed against probable injury, and reliability. The regulation at 21 CFR 860.7 , states that “[t]here is reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.” GMBT1 would not be payable in cases where the billing practitioner incurs no cost in acquiring and furnishing the DMHT device, or a patient procures the DMHT device independent of the practitioner. We will continue to monitor how DMHT devices are used as part of overall care.

We seek comment about other parameters that we should consider regarding the services described by GMBT1:

Whether payment should be made if the practitioner furnishes a digital device that has not been cleared by FDA for mental health treatment for a specific use, even if the digital device has been cleared by the FDA for another specific use;
Whether payment should be made for DMHT devices cleared by the FDA not only under 21 CFR 882.5801 but also under other regulations;
Whether and how payment might be limited if a patient discontinues use of the DMHT device before completing a course of treatment; and
Whether and how payment might be limited to a set number of DMHT devices per calendar month per patient.

In light of the pricing variability, as discussed above, we are proposing contractor pricing for code GMBT1. We seek comment regarding what national pricing methodology we might consider, including what potential crosswalks would be appropriate.

We are also proposing to establish payment for two additional new codes. These proposed codes are GMBT2 ( First 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the DMHT device from patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month ) and GMBT3 ( Each additional 20 minutes of monthly treatment management services directly related to the patient's therapeutic use of the digital mental health treatment (DMHT) device that augments a behavioral therapy plan, physician/other qualified health care professional time reviewing data generated from the DMHT device from patient observations and patient specific inputs in a calendar month and requiring at least one interactive communication with the patient/caregiver during the calendar month ). Under this proposal, GMBT1 requires that the billing practitioner who diagnosed the patient and prescribed or ordered the DMHT device or that billing practitioner's clinical staff must monitor the patient's therapeutic response to the DMHT device and adjust the behavioral health therapy plan as needed. GMBT2 and GMBT3 should only be billed when there is ongoing use of the DMHT device and should not be billed in cases where the patient discontinues use of the DMHT device.

For GMBT2 (first 20 minutes of monthly treatment management services directly related to use of the DMHT device), we propose valuing the first 20 minutes of treatment management services based on a direct crosswalk to CPT code 98980 (remote therapeutic monitoring first 20 minutes), which is assigned a work RVU of .62. For GMBT3 (each additional 20 minutes of monthly treatment management services directly related to DMHT device), we propose to value this code based on a crosswalk to CPT code 98981 (remote therapeutic monitoring each additional 20 minutes), which is assigned a work RVU of .61. We believe that the work and PE described by these crosswalk codes are analogous to the services described in GMBT2 and GMBT3, respectively, because they include similar physician/other qualified health care professional time in a calendar month requiring at least one interactive communication with the patient/caregiver during the calendar month. We welcome comments on the proposed RVUs.

In the CY 2019 PFS final rule ( 83 FR 59489 ), we finalized payment for six CPT codes regarding interprofessional consultations (99451, 99452, 99446, 99447, 99448, 99449). The six codes describe assessment and management services conducted through telephone, internet, or electronic health record consultations furnished when a patient's treating physician or other qualified healthcare professional requests the opinion and/or treatment advice of a consulting physician or qualified healthcare professional with specific specialty expertise to assist with the diagnosis and/or management of the patient's condition without the need for the patient's face-to-face contact with the consulting physician or qualified healthcare professional. We established coding and payment for Start Printed Page 61745 these services to reflect changing healthcare practices, technology, and the shift to treatment of chronic conditions in the Medicare population. In the CY 2019 PFS final rule ( 83 FR 59491 ), we established a policy to limit billing of these codes to the types of practitioners who can independently bill Medicare for E/M visits. We did not finalize the expansion of practitioners beyond those who can furnish E/M visits in the CY 2019 PFS final rule due to our belief that interprofessional consultations are primarily for the ongoing evaluation and management of the patient, including collaborative medical decision making among practitioners ( 83 FR 59491 ).

In the CY 2024 PFS proposed rule ( 88 FR 52369 ), we sought comment on expanding access to behavioral health services, including whether we should consider new coding to allow interprofessional consultation to be billed by practitioners in specialties whose covered services are limited by statute (Clinical psychologists at section 1861(ii) of the Act, Clinical social workers at section1861(hh) of the Act, Marriage and Family Therapists and Mental Health Counselors at sections 1861(lll)(1) and 1861(lll)(3) of the Act, respectively) to services for the diagnosis and treatment of mental illness (which includes substance use disorders). The CPT codes describing interprofessional consultation (CPT codes 99451, 99452, 99446, 99447, 99448, 99449) are currently limited to being billed by practitioners who can independently bill Medicare for E/M visits. As such, they cannot be billed by clinical psychologists, clinical social workers, marriage and family therapists, or mental health counselors because these practitioners cannot independently bill Medicare for E/M visits. We are proposing new codes that would allow clinical psychologists, clinical social workers, marriage and family therapists, and mental health counselors to bill for interprofessional consultations with other practitioners whose practice is similarly limited, as well as with physicians and practitioners who can bill Medicare for E/M services and would use the current CPT codes to bill for interpersonal consultations. These new codes would facilitate interprofessional consultations between treating/requesting practitioners and consultant practitioners, whether one or both of the practitioners is in a specialty whose practice is limited to the diagnosis and treatment of mental illness. When the treating/requesting practitioner or consultant practitioner is a physician or practitioner authorized to bill Medicare for E/M services, the practitioner would continue to bill using the current CPT codes that describe interprofessional consultation, listed previously in this section. Depending on which practitioner type is billing, and assuming all service requirements of the code descriptors are met, the consulting practitioner could bill the applicable codes, either HCPCS code (GIPC1-5) or CPT code (99451, 99452, 99446, 99447), determined by the amount of time spent on the consultation and whether a written and verbal consultation is provided or only a written consultation is provided. Similarly, depending on which practitioner type is billing, and assuming all service requirements of the code descriptors are met, the treating/requesting practitioner could bill either HCPCS code GIPC6 or CPT code 99449 for the time spent on their referral service.

We believe that proposing payment for these interprofessional consultations performed via communications technology such as telephone or internet (including videoconference) is consistent with our ongoing efforts to appropriately recognize and reflect behavioral health care within the PFS. Currently, there is no payment mechanism to recognize the time and effort of performing these services by clinical psychologists, clinical social workers, marriage and family therapists, or mental health counselors. We have also previously received comments from interested parties that by not making separate payment for these services, CMS would not be accurately paying for the work of both the treating and consulting practitioner in a consultative scenario. With the proliferation of team-based approaches to care that are often facilitated by electronic medical record technology, we believe that making separate payment for interprofessional consultations undertaken for the benefit of treating a patient will contribute to payment accuracy under the PFS for behavioral health services.

To further expand access to behavioral health services, we are proposing payment for six new G codes: GIPC1 ( Interprofessional telephone/internet/electronic health record assessment and management service provided by a practitioner in a specialty whose covered services are limited by statute to services for the diagnosis and treatment of mental illness, including a verbal and written report to the patient's treating/requesting practitioner; 5-10 minutes of medical consultative discussion and review ), GIPC2 ( Interprofessional telephone/internet/electronic health record assessment and management service provided by a practitioner in a specialty whose covered services are limited by statute to services for the diagnosis and treatment of mental illness, including a verbal and written report to the patient's treating/requesting practitioner; 11-20 minutes of medical consultative discussion and review ), GIPC3 ( Interprofessional telephone/internet/electronic health record assessment and management service provided by a practitioner in a specialty whose covered services are limited by statute to services for the diagnosis and treatment of mental illness, including a verbal and written report to the patient's treating/requesting practitioner; 21-30 minutes of medical consultative discussion and review ), GIPC4 ( Interprofessional telephone/internet/electronic health record assessment and management service provided by a practitioner in a specialty whose covered services are limited by statute to services for the diagnosis and treatment of mental illness, including a verbal and written report to the patient's treating/requesting practitioner; 31 or more minutes of medical consultative discussion and review ), GIPC5 ( Interprofessional telephone/internet/electronic health record assessment and management service provided by a practitioner in a specialty whose covered services are limited by statute to services for the diagnosis and treatment of mental illness, including a written report to the patient's treating/requesting practitioner, 5 minutes or more of medical consultative time ), and GIPC6 ( Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting practitioner in a specialty whose covered services are limited by statute to services for the diagnosis and treatment of mental illness, 30 minutes ). We welcome comments on this proposal.

Additionally, since these codes describe services that are furnished by the treating/requesting practitioner and the consultant practitioner without the involvement of the patient, we are proposing to require the treating practitioner to obtain the patient's consent in advance of these services, which would be documented by the treating practitioner in the medical record, similar to the conditions of payment associated with the CPT interprofessional consultation codes and certain other non-face-to-face services paid under the PFS. Obtaining advance patient consent includes ensuring that Start Printed Page 61746 the patient is aware that Medicare cost sharing applies to these services, including informing the patient that there may be cost sharing for two services (one for the treating/requesting practitioner's service and another for the consultant practitioner's service). We welcome comments on this proposal.

We are proposing to value the six proposed new G codes based on crosswalks to the six CPT codes for interprofessional consultations for practitioners who can independently bill Medicare for E/M visits (CPT codes 99451, 99452, 99446, 99447, 99448, 99449). We are proposing a work RVU of 0.35 for GIPC1 based on a crosswalk to CPT code 99446, a work RVU of 0.70 for GIPC2 based on a crosswalk to CPT code 99447, a work RVU of 1.05 for GIPC3 based on a crosswalk to CPT code 99448), a work RVU of 1.40 for GIPC4 based on a crosswalk to CPT code 99449, a work RVU of 0.70 for GIPC5 based on a crosswalk to CPT code 99451, and a work RVU of 0.70 for GIPC6 based on a crosswalk to 99452. Since there are no direct PE inputs assigned to the six CPT codes describing interprofessional consultation services on which we are basing the proposed valuation for the new HCPCS codes GIPC1 through GIPC6, we are not proposing any direct PE inputs for these codes. We welcome comments on this proposal.

In the CY 2024 OPPS final rule ( 88 FR 81809 through 81858 ), we finalized payment for IOP services furnished in hospital outpatient departments (HOPDs), Community Mental Health Centers (CMHCs), Federally Qualified Health Centers (FQHCs), and Rural Health Clinics (RHCs), and Opioid Treatment Programs (OTPs). We note that Section 4124 of the Consolidated Appropriations Act (CAA), 2023, authorized payment for IOP services in HOPDs, CMHCs, FQHCs, RHCs, and that we additionally used existing statutory authority to propose and finalize payment for IOP services furnished in OTPs. CMS is monitoring utilization and uptake of IOP services in these settings. We have heard from other treatment settings that furnish IOP services that do not fall into the categories of HOPDs, CMHCs, FQHCs, RHCs, or OTPs, such as freestanding SUD facilities, that have an interest in billing Medicare for these services. In light of this, we are seeking comment on whether IOP services are furnished in other settings in order to determine whether potential coding and payment for IOP services under the PFS would facilitate these services being billed in additional settings.

In particular, we are interested in feedback on the following questions, as well as any other relevant feedback:

To what extent do freestanding SUD facilities or other entities that furnish IOP services employ practitioner types who can supervise auxiliary personnel and bill Medicare for their services? For example, do they typically employ physicians, clinical psychologists, nurse practitioners, clinical nurse specialists, certified nurse midwives and physician assistants who are eligible to provide general supervision to auxiliary personnel who furnish behavioral health services?
Would bundled payments under the PFS similar to those finalized in the CY 2024 OPPS final rule ( 88 FR 81809-81858 ) better facilitate billing for IOP services in a broader range of settings?
If CMS outlined how freestanding SUD facilities could bill Medicare under the PFS, would there be an impact in underserved areas?
To what extent do freestanding SUD facilities see patients with Medicare or who are dually eligible for Medicare and Medicaid?

Additionally, we are seeking comment on entities that offer community-based crisis stabilization, including 24/7 receiving and short-term stabilization centers, that provide immediate access to voluntary and/or involuntary care, without the need for a referral. Regarding such crisis stabilization units, we are interested in feedback on the following questions, as well as any other relevant feedback:

++ What kind of services do crisis stabilization units provide? Do crisis stabilization units provide services similar to those described by the psychotherapy for crisis codes (CPT codes 90839 and 90840)?

++ Does the definition of crisis stabilization unit vary by State? If so, what are the variations and similarities across States?

++ If CMS outlined how crisis stabilization units could bill Medicare under the PFS, would there be an impact in underserved areas?

++ To what extent do crisis stabilization units see patients with Medicare or who are dually eligible for Medicare and Medicaid?

++ To what extent do crisis stabilization units employ practitioner types who can supervise auxiliary personnel and bill Medicare for their services. For example, do crisis stabilization units typically employ physicians, clinical psychologists, nurse practitioners, clinical nurse specialists, certified nurse midwives and physician assistants who are eligible to provide general to auxiliary personnel who furnish behavioral health services?

Additionally, as a separate example, we've received information from interested parties that there is a similar concern regarding urgent care centers more broadly. These interested parties note that hospital emergency departments are often used by beneficiaries to address non-emergent urgent care needs that could be appropriately served in less acute settings, but where other settings, such as physician offices, urgent care centers or other clinics, are not available or readily accessible. Patients enter EDs to treat common conditions like allergic reactions, lacerations, sprains and fractures, common respiratory illnesses (for example, flu or RSV), and bacterial infections (for example, strep throat, urinary tract infections or foodborne illness). Conditions like these often can be treated in less acute settings. We are interested in system capacity and workforce issues broadly and are interested in hearing more on those issues, including how entities such as urgent care centers can play a role in addressing some of the capacity issues in emergency departments. In particular, we are interested in feedback on the following questions, as well as any other relevant feedback:

What types of services would alternative settings to EDs need to offer to meet beneficiaries' non-emergent, urgent care needs?
Does the current “Urgent Care Facility” Place of Service code (POS 20) adequately identify and define the scope of services furnished in such settings? Is this place of service code sufficiently distinct from others such as “Walk-in Retail Health Clinic (POS 17) and “Office” (POS 11)? If not, how might these Place of Service code definitions be modified?
Does the existing code set accurately describe and value services personally performed by professionals and costs incurred by the facility in these settings?
How might potential strategies to reduce overcrowding and wait times in EDs advance equity in access to health care services?

Lastly, we are seeking comment regarding Certified Community Behavioral Health Clinics (CCBHCs). Start Printed Page 61747 Specifically, we are interested in feedback on the following questions:

++ What kind of services do CCBHCs provide? Do they provide IOP services, services for the treatment of substance use disorders, psychotherapy, behavioral health integration, community health integration, or principal illness navigation services to patients with either Medicare or another payer?

++ If CMS outlined how CCBHCs could bill Medicare under the PFS, would there be an impact in underserved areas?

++ To what extent do CCBHCs see patients with Medicare or who are dually eligible for Medicare and Medicaid?

++ To what extent do CCBHCs employ practitioner types who can supervise auxiliary personnel and bill Medicare for their services? For example, do CCBHCs employ physicians, clinical psychologists, nurse practitioners, clinical nurse specialists, certified nurse midwives and physician assistants who are eligible to provide general supervision to auxiliary personnel who furnish behavioral health services?

Section 1862(a)(12) of the Act generally precludes payment under Medicare Parts A or B for any expenses incurred for services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth. (Collectively here, we will refer to “the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth” as “dental services.”) That section of the statute also includes an exception to allow payment to be made for inpatient hospital services in connection with the provision of such dental services if the individual, because of their underlying medical condition and clinical status or because of the severity of the dental procedure, requires hospitalization in connection with the provision of such services. Our regulation at § 411.15(i) similarly excludes payment for dental services except for inpatient hospital services in connection with dental services when hospitalization is required because of: (1) the individual's underlying medical condition and clinical status; or (2) the severity of the dental procedure.

Fee for service (FFS) Medicare Parts A and B also make payment for certain dental services in circumstances where the services are not considered to be in connection with dental services within the meaning of section 1862(a)(12) of the Act. In the CY 2023 PFS final rule ( 87 FR 69663 through 69688 ), we clarified and codified at § 411.15(i)(3) that Medicare payment under Parts A and B could be made when dental services are furnished in either the inpatient or outpatient setting when the dental services are inextricably linked to, and substantially related and integral to the clinical success of, other covered services. We also added several examples of clinical scenarios that are considered to meet that standard under § 411.15(i)(3) and amended that regulation to add more examples in the CY 2024 PFS final rule ( 88 FR 79022 through 79029 ).

In the CY 2023 PFS final rule, we also established a process whereby we accept and consider submissions from the public (the “public submission process”) to assist us to identify additional dental services that are inextricably linked to, and substantially related and integral to the clinical success of, other covered services ( 87 FR 69663 through 69688 ). Hereafter in this section we will refer to these services as dental services that are “inextricably linked to other covered services.”

We also note that the examples provided in our regulation at § 411.15(i)(3)(i) are not exclusive. Medicare administrative contractors (MACs) retain discretion to determine on a claim-by-claim basis whether a patient's circumstances do or do not fit within the terms of the preclusion or exceptions specified in section 1862(a)(12) of the Act and § 411.15(i).

In the CY 2024 PFS final rule, we discussed our plans to issue educational and outreach materials to inform billing and payment for finalized policies for dental services. We reiterated our commitment to review submissions we receive through the public submissions process. We also expressed our intention to continue to engage in discussions with the public on a wide spectrum of issues relating to Medicare payment for dental services that may be inextricably linked to other covered services. We also described our partnership with the Agency for Healthcare Research and Quality (AHRQ) to assist us to review available clinical evidence and consider the relationship between dental services and specific covered medical services and to identify other potential clinical circumstances in which dental services are inextricably linked to other covered services ( 88 FR 79029 ).

In this proposed rule, we (1) describe recent literature review conducted by our partner agency, AHRQ, on the potential connection between sickle cell disease and hemophilia and dental services; (2) summarize submissions we received through the public submission process for consideration in CY 2025 rulemaking; (3) propose to codify in section § 411.15(i)(3)(i)(A) additional policies to permit payment for certain dental services that are inextricably linked to other covered services (certain dental services for patients receiving dialysis services to treat end-stage renal disease (ESRD)); (4) request public comment and information related to other clinical scenarios that may involve dental services that are inextricably linked to other covered services; and (5) include proposals related to Medicare billing and payment policy for dental services. We also include a request for information regarding oral sleep apnea appliances.

We have partnered with AHRQ to help us consider the relationship between dental services and other specific covered services. Specifically, AHRQ reviews available clinical evidence regarding this relationship, and provides analysis of clinical scenarios where dental services may be inextricably linked to other covered services. To better address the public's immediate dental needs, AHRQ conducted rapid response reports instead of comprehensive assessments. With these rapid response reports, we can better specify which payments can be made under Medicare Parts A and B for certain dental services that are inextricably linked to other covered services.

Through the public submissions process for consideration in CY 2024 rulemaking, interested parties nominated dental services for individuals living with sickle cell disease (SCD) or hemophilia, urging us to consider adding payment for these services ( 88 FR 52374 ). The submissions included information and references supporting the inclusion of dental services that are inextricably linked to, and substantially related and integral to the clinical success of, the covered services used in the treatment of SCD or hemophilia, because such dental services serve to mitigate the substantial risk to the success of the medical services. Submissions supported the importance of preventing dental Start Printed Page 61748 infections among individuals with SCD to reduce the need for the extensive procedures that may lead to bleeding complications and hospitalization. They also provided information detailing increased dental caries and periodontal disease in people with SCD, [ 158 ] many of whom lose a number of teeth, which greatly limits nutrition, general well-being, and overall quality of life. Interested parties recommended that we adopt a policy to allow payment for dental services for individuals with hemophilia ( 88 FR 79032 ). They emphasized that periodic dental care reduces the risks of dental complications that may require hemostatic therapy or oral surgeries requiring clotting factor replacement treatment. [ 159 160 161 ] Many submitters suggested that maintaining good oral health leads to improved outcomes for patients with these two conditions.

Acknowledging the importance of dental health to overall well-being of patients with these two types of diseases, in the CY 2024 proposed rule, we summarized information provided by submitters utilizing the public submission process and solicited comment on whether certain dental services are inextricably linked to covered services in the treatment of SCD ( 88 FR 52374 ). In the CY 2024 PFS final rule, we noted that several commenters suggested expanding dental service coverage for individuals with SCD. They supported covering dental services essential for treating SCD, including hydroxyurea therapy. Another commenter advocated for expanding coverage for dental services in cases of pain crises or dental abscesses in individuals with SCD. They emphasized that improved access to dental care could improve the quality of life for individuals with SCD and reduce healthcare costs by enabling more suitable treatment options and decreasing hospital stays. One commenter questioned the clinical basis for providing dental benefits for SCD or hemophilia due to their low prevalence in the Medicare population. Ultimately, after consideration of public comments, we did not expand the examples under § 411.15(i)(3)(i) to include additional covered medical services for SCD. We concluded that the information provided by commenters did not sufficiently demonstrate that dental services are essential to the clinical success of hydroxyurea therapy or other treatments for SCD ( 88 FR 79032 ). Please refer to CY 2024 final rule ( 88 FR 79031 through 79032 ) for more detailed information.

In the CY 2024 PFS proposed rule, we similarly solicited comments on hemophilia regarding whether certain dental services are considered so integral to the primary covered services that the necessary dental interventions are inextricably linked to, and substantially related and integral to clinical success of, the primary covered services for individuals with hemophilia ( 88 FR 52382 ). Several commenters advocated for allowing Medicare Part A and Part B payment for dental services for individuals with hemophilia citing guidelines from Hemophilia Treatment Centers (HTCs), the Centers for Disease Control and Prevention (CDC), and the World Federation of Hemophilia (WFH). They emphasized the importance of good oral health to prevent complications like gum bleeding and major dental surgeries, especially in those with severe/moderate hemophilia. Another commenter supported this perspective, noting that regular dental care reduces the need for clotting factor replacement therapy. While we acknowledged the importance of maintaining oral health to prevent complications such as serious gum bleeding, especially problematic for those with hemophilia, we also reiterated that for the purposes of the PFS payment policy for dental services inextricably linked to covered medical services, our statute and regulations require that specific evidence supports the integral connection between dental services and clinical success in managing hemophilia-related medical services, and, therefore, we did not expand the examples under § 411.15(i)(3)(i) to include additional covered medical services for hemophilia. Please refer to CY 2024 final rule ( 88 FR 79032 through 79033 ) for more detailed information.

While interested parties have suggested the interaction of oral health care for SCD or hemophilia, we noted that further research is necessary to find specific evidence supporting specific medical services for which dental services are inextricably linked to their clinical success. To gain further understanding of any potential relationship between dental services and specific covered SCD or hemophilia medical services, we again partnered with researchers at the Agency for Healthcare Research and Quality (AHRQ) to review available clinical evidence regarding the relationship between dental services and covered SCD or hemophilia medical services. AHRQ created two rapid response reports, which summarized recent evidence, aiming to inform CMS policy development related to the possible linkage between dental services and treatment modalities and services for SCD or hemophilia patients. For more detailed information about the search strategies and findings, please refer to the two AHRQ rapid response reports available at https://effectivehealthcare.ahrq.gov/products/sickle-cell-dental/research and https://effectivehealthcare.ahrq.hgov/products/hemophilia-dental/research .

As stated in the AHRQ rapid response report, SCD is a genetic hematologic disorder affecting approximately 100,000 individuals in the U.S., [ 162 ] characterized by abnormal hemoglobin formation in red blood cells, leading to complications such as pain, infection, acute chest syndrome, and stroke. Hydroxyurea, a commonly used therapeutic measure, [ 163 ] which increases fetal hemoglobin levels, which has a higher affinity for oxygen than adult hemoglobin. This therapy can prevent sickling or curvature of red blood cells and help SCD patients. SCD patients can experience dental complications due to Start Printed Page 61749 ischemia, [ 164 ] including delayed tooth eruption, enamel disorders, and tongue cell changes. Ischemic and inflammation affects enamel, gums, and jawbones that can cause paresthesia and tooth pain. In response to a producing more red blood cells to make up for anemia, bone marrow expansion can lead to malocclusion and reduced bone density. [ 165 166 ] The AHRQ's rapid response report highlights that despite hydroxyurea's long-term use to treat SCD, uncertainty remains regarding whether dental care before, during, or after treatment of SCD with hydroxyurea (and other lesser prescribed treatments) influences clinical outcomes in patients.

In their rapid response, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram, a flow diagram used in systematic reviews and meta-analyses intended to describe findings of the review, revealed that initially, 762 records were identified from large databases, and 934 records were identified from grey literature sources covering 57 years. Following the exclusion of ineligible studies, a total of five unique records were included, extracted, and evaluated in the rapid response report. The rapid response report found that no studies examined the specific impact of dental care on SCD treatment outcomes; however, the rapid response identified three relevant clinical practice guidelines and two reviews with recommendations for dental care for patients with SCD. According to the rapid response, all guidelines and reviews highlighted the importance of preventive dental measures, with the Sickle Cell Society in the UK recommending the inclusion of a hematologist in the dental care team for SCD patients. However, these guidelines primarily focused on managing SCD during dental services rather than the impact of dental care on the improvement of SCD treatment outcomes, which differs from the regulatory standard in § 411.15(i)(3)(i) that the dental services are inextricably linked to, and substantially related and integral to the clinical success of, other covered services.

The two rapid reviews with recommendations highlighted several key areas of dental management for SCD patients. They emphasized the importance of preventive dental care to reduce the risk of oral infections, periodontal diseases, and major dental procedures. Additionally, the studies recommended that a complete blood count should be evaluated prior to invasive dental procedures to mitigate infection risks in SCD patients. [ 167 168 ] Overall, the findings from the AHRQ rapid response reports underscore the gaps in the current literature concerning the management of oral health care for individuals with SCD. The body of evidence evaluating dental services before, during, or after the treatment of SCD is lacking in primary clinical data and is limited to available clinical practice guidelines and reviews with recommendations. While guidelines and reviews have addressed particular aspects of dental care, such as early intervention and the importance of collaboration between dentists and hematologists, there is an absence of primary evidence that informed the potential effect of dental care on SCD treatment outcomes.

As stated in their report, hemophilia is a rare inherited disorder characterized by the deficiency or absence of blood-clotting proteins, affecting approximately 20,000-33,000 males in the U.S. [ 169 ] There are three distinct types of hemophilia (A, B, and C) according to the specific clotting factor that is deficient or missing (VIII, IX, and XI, respectively). Treatment for all three types of hemophilia is similar but may vary based on the severity of disease, and typically involves replacing the deficient or missing clotting factor. [ 170 ] Anticoagulation issues in hemophilia patients can pose challenges for dental specialists due to the increased risk of secondary bleeding after oral surgery. [ 171 ] Severe hemophilia patients face spontaneous bleeding in joints, muscles, or soft tissues, sometimes life-threatening, while mild to moderate cases may experience excessive bleeding, including after dental extractions. [ 172 ]

According to the rapid response reports provided by AHRQ, clotting factor replacement therapy is the standard treatment for individuals with hemophilia. Replacement therapy, which can be self-administered or given at a hemophilia treatment center, can be used to stop a spontaneous bleeding episode (episodic care), or to prevent bleeding from occurring (prophylactic care). However, consistent/prolonged factor replacement can cause antibody inhibitor development. [ 173 ] While clotting factor replacement therapy remains the standard treatment for hemophilia, uncertainty persists regarding whether dental care before, during, or after treatment of hemophilia improves clinical outcomes in patients. Excessive bleeding, often associated with invasive or traumatic dental procedures, poses challenges when treating patients with hemophilia. Hence, the timing of dental treatment in relation to factor replacement therapy may influence outcomes.

In AHRQ's rapid response, a total of 1,414 records from large databases and 2,238 records from grey literature, spanning 73 years, were identified. Strictly following the exclusion criteria depicted in the PRISMA diagram, the response included, extracted, and evaluated a total of four unique publications in this rapid response. The rapid response report identified four publications: two practice guidelines and two reviews with recommendations. The included publications advised hemophilia patients to consult hematologists or hemophilia treatment centers before dental procedures. They emphasized interdisciplinary collaboration between dentists and hematologists for treatment planning. Included guidelines recommended performing dental services during hemophilia treatment with coagulation factor replacement therapy. However, all four reviewed publications mainly addressed hemophilia A and B, with little mention Start Printed Page 61750 of hemophilia C. Similar to the findings related to SCD, the body of evidence evaluating dental services before, during, or after the treatment of hemophilia is lacking in primary clinical data and is currently limited to available guidelines. These guidelines emphasize the importance of professional dental care during hemophilia treatment with clotting factor replacement therapy to reduce bleeding complications, rather than the inextricable link between certain dental services and covered services for hemophilia, which is the regulatory standard in § 411.15(i)(3)(i) for clinical scenarios under which payment can be made for dental services under Medicare Parts A and B.

After reviewing AHRQ's comprehensive rapid reviews for both SCD and hemophilia, we found the evidence related to the linkage between dental services and outcomes for covered medical services for both SCD and hemophilia lacking in the current research and literature. Both rapid responses noted a limited number of studies examining the impact of dental care on outcomes for individuals with SCD or hemophilia. Currently, the evidence base does not appear to support that dental services may be inextricably linked to covered services for SCD or hemophilia. Also, the body of evidence evaluating dental services before, during, or after the treatment of SCD and hemophilia lacks primary clinical data and relies on available guidelines and reviews. Given limited information, however, both the SCD and hemophilia rapid responses support the need for preventive care and patient education as essential practices for both SCD and hemophilia patients to minimize the likelihood of oral infections, periodontal disease, and major dental procedures. In addition, both rapid response reports recommend collaborative efforts between dentists, hematologists, and specialized clinics as crucial for improved patient care, despite the lack of primary evidence informing the potential effect of dental care on treatment. While both rapid response reports discuss their findings on the importance of a multidisciplinary approach, both rapid response reports also found that the current reviews and guidelines do not address dental care as a standard of care that is inextricably linked to hemophilia or SCD treatment. Instead, their focus was on managing the respective conditions during dental services, not on the inextricable linkage between the dental and medical services.

In conclusion, interested parties, including industry organizations, public commenters, and organizations submitting through the public submissions process, requested that CMS consider the conditions of SCD and hemophilia for the purposes of the Medicare Parts A and B payment policy for dental services that are inextricably linked to other covered services. As part of our commitment to exploring the inextricable link between dental and covered services associated with SCD and hemophilia, we partnered with AHRQ to generate comprehensive rapid responses on these topics. However, the AHRQ's rapid response reports show that the current evidence base does not appear to support that dental services may be inextricably linked to services for SCD or hemophilia within the meaning of the standard at § 411.15(i)(3), and we are not proposing to add these conditions to our regulation. Moreover, the findings of the AHRQ rapid response reports highlight that this area merits further study by researchers and industry in order to further explore potential connections between dental services and improved outcomes for individuals with SCD or hemophilia. Given the new and evolving therapies and treatments in this space, we will consider conducting additional evaluations as new studies are carried out to examining the impact of dental services on SCD and hemophilia outcomes and will take any future studies into consideration.

We continue to seek clinical evidence demonstrating the integral connection between dental services and other covered services for SCD and hemophilia, and we welcome any comments or literature regarding these two conditions. We are not proposing to amend § 411.15(i)(3)(i) as we have not identified additional dental services that are inextricably linked to certain services associated with SCD or hemophilia. However, we remain open to considering any such services identified by public commenters, and, if sufficient evidence is presented, we may consider adding such services to our regulations in the final rule. In addition, we encourage interested parties to supply additional submissions for consideration in future PFS rulemaking through the public submission process, which may include relevant medical evidence, peer-reviewed literature, clinical guidelines, or supporting documentation as described in section II.J.1.c. of this proposed rule.

As we have in the CY 2023 and CY 2024 PFS final rules, we continue to encourage interested parties to engage with us regularly and to submit recommendations through our public submissions process for our consideration of additional clinical scenarios where dental services may be inextricably linked to covered services under § 411.15(i)(3)(i). Through our annual public submissions process, interested parties should provide clinical evidence and other documentation to support their recommendations ( 87 FR 69685 ). We are using the PFS annual rulemaking process to discuss public submissions and to consider whether the clinical scenario described in the submissions should be added to § 411.15(i)(3)(i) as an example of a circumstance where payment can be made for dental services inextricably linked to other covered services. Using our annual notice and comment rulemaking process to discuss submitted recommendations allows the public to comment and submit further medical evidence and important feedback to assist us in evaluating whether certain dental services furnished in certain clinical scenarios would meet the standard to permit Medicare payment for the dental services.

We review clinical evidence included in submissions and public comments in rulemaking, as well as information and analysis provided by AHRQ in rapid response reports, to assess whether there is an inextricable link between certain dental services and certain covered services. We would find that there is an inextricable link where the standard of care for a service is such that the practitioner would not proceed with the procedure or service without performing the dental service(s), for example, because the covered services would or could be significantly and materially compromised absent the provision of the inextricably-linked dental services, or where dental services are a clinical prerequisite to proceeding with the primary medical procedure and/or treatment. As such, documentation accompanying recommendations should include medical evidence to support that certain dental services are inextricably linked to certain covered services. Specifically, as we specified in the CY 2023 PFS final rule, we request that the medical evidence included in submissions through the public submissions process should:

(1) Provide support that the provision of certain dental services leads to improved healing, improved quality of surgery outcomes, and the reduced likelihood of readmission and/or surgical revisions because an infection has interfered with the integration of the Start Printed Page 61751 medical implant and/or interfered with the medical implant to the skeletal structure;

(2) Be clinically meaningful and demonstrate that the dental services result in a material difference in terms of the clinical outcomes and success of the procedure such that the dental services are inextricably linked to other covered services; and,

(3) Be compelling to support that certain dental services would result in clinically significant improvements in quality and safety outcomes (for example, fewer revisions, fewer readmissions, more rapid healing, quicker discharge, and quicker rehabilitation for the patient) ( 87 FR 69686 ).

This evidence should include at least one of the following:

(1) Relevant peer-reviewed medical literature and research/studies regarding the medical scenarios requiring medically necessary dental care;

(2) Evidence of clinical guidelines or generally accepted standards of care for the suggested clinical scenario;

(3) Other ancillary services that may be integral to the covered services; and/or

(4) Other supporting documentation to justify the inclusion of the proposed medical clinical scenario requiring dental services ( 87 FR 69686 ).

Submissions should focus on the inextricably linked relationship between dental services and other services necessary to diagnose and treat the individual's underlying medical condition and clinical status, and whether it would not be clinically advisable to move forward with the other covered services without performing certain dental services. To be considered for purposes of CY 2026 PFS rulemaking, submissions through our public submissions process should be received by February 10, 2025, via email at [email protected] . To facilitate processing, interested parties should include the words “dental recommendations for CY 2026 review” in the subject line of their email submission. We continue to stress to submitters that recommendations must include at least one of the types of evidence listed earlier. We further note that we may also consider recommendations that are submitted as public comments during the comment period following the annual publication of the PFS proposed rule.

We thank all those who submitted recommendations for additional clinical scenarios for which they believe Medicare payment for dental services will be consistent with the policies we codified at § 411.15(i)(3)(i), under which Medicare payment may be made for dental services when they are inextricably linked to other covered services. We received thirteen submissions from various organizations and individuals on or before February 10, 2024. Several submitters represented dozens or hundreds of other organizations in making these recommendations. We received one submission after the deadline that presented nominations for clinical scenarios addressed by other submitters, and a proposal outside the scope of clinical scenarios where dental services may be inextricably linked to covered medical services under § 411.15(i)(3)(i).

One submitter recommended that oral health care is essential to the success of treatments for individuals with sickle cell disease and other hematologic disorders. The submitter asserted that providing appropriate and timely dental care is a crucial component for the successful treatment of many hematologic diseases, including SCD, hemophilia, and many blood cancers, such as acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic myeloid leukemia, and multiple myeloma. The submitter noted that we finalized that payment can be made for certain dental services prior to or contemporaneously with chemotherapy, CAR T-Cell therapy, and the administration of high-dose bone-modifying agents (anti-resorptive therapy), when used in the treatment of cancer. The evidence submitted showed that among individuals with a sickle cell crisis, those with dental infections were 72% more likely to be admitted to the hospital than those without dental infections. The same submitter also requested that we consider payment of dental services following organ transplantations (including bone marrow or hematopoietic stem cell transplantation (HSTC)) because maintenance of oral hygiene after HSCT minimizes the severity of oral and dental infections, which is important because chronic graft versus host disease (cGVHD) is common following allogeneic HSCT. The submitter stated that frequent dental evaluations of patients with cGVHD are critical because of the increased rate of dental caries associated with this disease; furthermore, gingivitis and periodontal disease should be monitored and managed appropriately to avoid additional infection. Finally, the submitter also stated that multiple tooth extractions without replacement of dentition leave patients with a poor capacity to eat and may negatively impact the success of the transplant and quality of life. This submitter also recommended including cell and gene therapy for SCD as a clinical treatment scenario for future consideration of potentially inextricably linked dental services.

Another submitter asserted that patients frequently present with complications extending three years or more following the direct treatment of not only head and neck cancers but also other cancer types. The submitter also asserted that a comparable trend may be seen in patients experiencing complications following anti-resorptive drug therapy, for non-cancer-related conditions. They recommended that payment be available for specific dental services during a minimum of 2 years post-treatment for head and neck cancer and up to 5 years for those who have received radiotherapy. They emphasized the current evidence and literature as supporting the provision of Medicare payment for a minimum of 2 years, with the understanding that some patients may require dental or oral healthcare beyond this period due to delayed or late-onset complications, and that the timeline for the emergence of oral or dental complications post- treatment is not uniformly linear and can significantly vary among patients. They also stated that literature supports the extension of Medicare payment to include certain dental services furnished post-anti-resorptive therapy, when used in the treatment of cancer for at least two years following treatment. Lastly, this submitter stated there is an inextricable risk of the development of severe dental and oral complications, such as osteoradionecrosis/medication-related osteonecrosis of the jaw, in patients who have undergone the specific treatments for which we have identified certain inextricably linked dental services. They suggested that once patients receive these treatments, patients are perpetually at risk for developing such complications and recommended that current Medicare payment for dental services should align with the long-term healthcare needs of these patients.

We are not accepting the commenters' suggestion to include specific time limits within the exception in § 411.15(i)(3). We note again that MACs have the flexibility to determine on a claim-by-claim basis whether payment can be made for certain dental services for beneficiaries, such as those receiving other immunotherapies that may involve a lymphodepleting component, consistent with § 411.15(i)(3). That regulation states the general rule that Start Printed Page 61752 Medicare Parts A and B payment can be made for certain dental services that are inextricably linked to, and substantially related and integral to the clinical success of, covered services; and then provides a non-exclusive list of examples of clinical scenarios under which payment can be made. Thus, a MAC has discretion to decide on a case-by-case basis that payment can be made for certain dental services in other circumstances not specifically addressed under § 411.15(i)(3)(i)

Several submitters recommended that we provide for payment of medically necessary dental services for individuals with autoimmune diseases who are initiating or undergoing immunosuppressive or immunomodulator therapy (“immunosuppressive therapy”). They stated that immunosuppressive therapy can be severely complicated and compromised by oral/dental disease and conditions. The submitters provided references to numerous clinical studies and other supporting documentation in support of dental services in these clinical circumstances being inextricably linked to immunosuppressive therapies for which payment may be made in accordance with § 411.15(i)(3). They noted that while higher dosing is used for cancer chemotherapy and organ transplant rejection prevention, the therapy's duration is generally much shorter than when used in autoimmune disease therapy and that the longer-term duration of use for managing symptoms of autoimmune disease can expose patients to ongoing serious risk of complicating infections for decades. They relayed that the American College of Rheumatology states it is vital for patients to receive appropriate dental evaluation and prompt treatment so they can continue their immune suppressant medications. The submitter explained that dental infections could spread more easily, and therefore faster, when host immunity is compromised by immunosuppressing/immunomodulating drugs via three pathways for the bacteria to spread: locally through facial spaces, through the bloodstream, and by aspiration. They stated that outcomes similar to systemic infection or sepsis and other complications can follow for those receiving immunosuppressive therapy to treat autoimmune diseases. They recommended immunosuppressive therapy to treat autoimmune diseases should not proceed until a dental or oral exam is performed to address the oral complications and/or clear the patient of an oral or dental infection. We discuss these recommendations and supporting evidence in section II.J.4. of this proposed rule.

Several submitters recommended that dental treatments can be integral to the clinical success of covered nephrology-related medical services including services received by beneficiaries who are immunocompromised by end-stage renal disease (ESRD), chronic kidney disease (CKD), other renal diseases, as well as kidney transplant candidates maintained on immunosuppressive medications. They stated that all of these patients are at increased risk of infection, complications, and malnutrition from dentally sourced pathogens. Submitters stated that Medicare ESRD beneficiaries on dialysis are at greater risk for developing complications such as cardiovascular conditions, malnutrition, anemia, and infections, making dental services more critical to the success of kidney care treatments. They further stated that pre-transplantation dental care involves eliminating possible sources of oral infection that can lead to a systemic infection following transplant and that without access to dental services, individuals on dialysis may not qualify for kidney transplantation or may have severe complications after the transplant. One of the submitters noted that dialysis clinicians report that many bloodstream infections (BSI) begin with bacteria in the mouth and that regular dental visits could have a positive impact on reducing BSI. They added that the Society for Vascular Surgery has noted that transient bacteremia from dental infections can seed hemodialysis access grafts. Among strategies to prevent infection of vascular grafts, recommended preoperative measures include identifying and treating remote site infections, including dental sites. We discuss these recommendations and supporting evidence in section II.J.2. of this proposed rule.

More than half of the submissions expressed support for almost identical proposals from a couple of other submitters, recommending that dental services are inextricably linked to covered medical services used for the treatment of Medicare beneficiaries with diabetes. They agreed that the delivery of appropriate dental services in accordance with clinical guidelines and standard of care is substantially related and integral to the optimal outcome of these covered medical services. They offered clinical studies documenting that treatment of oral infections, such as periodontitis and its related inflammation, meaningfully improves the treatment and management of diabetes. They stated, by contrast, the absence of treatment of chronic dental infections complicates covered medical treatment for the management of diabetes and exacerbates insulin resistance, worsens glycemic control, and other diabetes related complications. They noted that the relationship between oral diseases and diabetes mellitus is complex. Diabetes is known to increase the risk and severity of oral diseases, such as periodontitis (gum inflammation and bone loss), tooth loss, dry mouth, and oral fungal infections. Additionally, oral diseases are documented as affecting blood glucose control and contributing to the development of diabetes complications, such as retinopathy, neuropathy, cardiovascular disease, and kidney disease. They believe reciprocal management of glycemic control and periodontal disease decreases risk for and actual cases and severity of diabetes and periodontal disease. We discuss these recommendations and the supporting clinical evidence in section II.J.3 of this proposed rule.

We have received information and requests from interested parties, including entities submitting information through the public submissions process as well as organizations providing comments in response to prior rulemaking efforts, that an inextricable linkage exists between dental services and dialysis treatment services for individuals diagnosed with end-stage renal disease (ESRD) who are receiving dialysis services, particularly those experiencing comorbidities. Commenters and submitters have stated that dental treatment is inextricably linked and integral, and substantially related to the clinical success and outcomes of covered dialysis medical services.

In the CY 2024 PFS final rule, we stated that commenters had provided comments in response to the CY 2024 PFS proposed rule supporting the coverage of annual dental examinations, and treatment as clinically indicated, for individuals with chronic kidney disease and ESRD. The commenters stated that chronic immunosuppression increases the risk of dental infections leading to potentially deadly complications including BSI, peritoneal dialysis-associated peritonitis, and the exacerbation of chronic cardiovascular conditions. They also stated that when established by patient-specific medical and dental parameters, dental services can be unquestionably integral to the Start Printed Page 61753 outcome of covered medical procedures. We thanked the commenters for the information they submitted regarding these suggestions; however, at that time, commenters did not provide sufficient evidence to support an inextricable link between certain dental services and certain covered services for chronic kidney disease and ESRD ( 88 FR 79034 ).

Additionally, submitters provided information through the public submissions process as described in section II.J.1.c. of this proposed rule for our consideration in CY 2025 rulemaking. The submitters stated that there is a connection between dental services to identify and address dental or oral infections and covered medical services for individuals receiving dialysis in the treatment of ESRD.

ESRD is a medical condition in which a person's kidneys successively experience loss of functionality on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life. [ 174 ]

Chronic kidney disease (CKD) is a progressively debilitating disease and is marked by the presence of kidney damage or reduction in the kidneys' filtration rate. CKD is a state of progressive loss of kidney function, in that the disease worsens over time and cannot be reversed, ultimately resulting in the need for renal replacement therapy, generally dialysis or transplantation. [ 175 ] The Kidney Disease Improving Global Outcomes (KDIGO) Foundation established guidelines that define five stages of CKD using kidney damage markers, including factors that determine proteinuria (level of protein in the urine) and glomerular filtration rate (level of kidney function/filtration) in its KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. [ 176 ] Chronic kidney disease is generally defined as the presence of two factors (glomerular filtration rate [GFR] less than 60 mL/min and albumin greater than 30 mg per gram of creatinine) along with abnormalities of kidney structure or function for greater than three months. Stage 5 of CKD is labeled end-stage renal disease (ESRD) with a GFR of less than 15 mL/min. [ 177 ] According to the NIH, more than 500,000 people in the United States live with ESRD. [ 178 ]

Per the American Academy of Family Physicians, individuals with ESRD are typically referred to nephrologists for the development of treatment plans. Collectively the various modalities utilized to replicate kidney function are referred to as renal replacement therapy (RRT). Most ESRD patients are treated with dialysis, regardless of whether transplantation ultimately occurs. Generally, kidney transplantation typically yields the best patient outcomes; however, not all patients with ESRD are eligible for or able to undergo transplantation, and therefore continue dialysis treatment. [ 179 ] Standards of medical care for CKD outline the need for monitoring for signs of progression of the disease and early referral to specialists for RRT. [ 180 ] Dialysis is generally supplied via two primary modes: hemodialysis or peritoneal dialysis. In hemodialysis, blood is filtered through a dialyzer, outside of the body. A dialyzer is sometimes referred to as an “artificial kidney.” [ 181 ] To access the circulatory system, several access points may be placed and utilized, including an arteriovenous (AV) fistula, AV graft, and in some cases a central venous catheter. [ 182 183 184 ] In peritoneal dialysis, a fixed catheter is placed in the abdomen, and dialysis solution is administered into the abdomen. The solution absorbs wastes and excess fluid from the patient's body. [ 185 186 ]

Submissions we received through the public submissions process for consideration in CY 2025 rulemaking provided information regarding the potential linkage between dental services and specific covered medical services associated with ESRD and dialysis including:

CPT codes 36901-36906: Dialysis circuit procedures;
CPT codes 90935, 90937, 90940: Hemodialysis procedures;
CPT code 90961: Physician or other qualified healthcare professional visits for ESRD;
CPT codes 90989-90999: Other dialysis procedures; and,
DRG code 872: Hosp

How I Applied to IAPT Training

IAPT… PWP… What does it all mean?!

Is IAPT right for you?

Experience is key

So how do I apply?

How the UoN Careers team can help you

Previous Post

Leave a Reply Cancel reply

Subscribe by email

Recent posts

Find, follow, join us

Trainee Psychological Wellbeing Practitioner Interview Questions and Answers

What is a Psychological Wellbeing Practitioner?

Stepped Care Model

Stages of a PWP

Psychology and Counselling Courses Online Mega Bundle

What are the ways of becoming a Psychology Wellbeing Professional?

Apprenticeship

University programs

Online courses

Training programs

Presentation

Top Courses of this Category

Psychology Course for Narcissistic Personality (NPD) Disorder

Drug and Alcohol Worker Course Online

Psychology Masterclass Course Online: Learn Behavioural Psychology

Psychology, Counselling, Psychotherapy & Anxiety – 4 Courses Bundle

Advanced Diploma in Psychology Course

Don’t Panic:

Strong basics:

Look Sharp:

Develop Your Team to Lead The Industry

What does PWP work involve?

What are the essential values in mental health, and which, in your opinion, is the most important?

What skills and qualities are needed to work in mental health?

What is the complete form of IAPT?

Can you tell me about the Stepped care model?

What is the aim of the Stepped Care Model?

What does confidentiality mean to you?

What are the challenges we face now in the mental health sector?

How would you implement health and safety procedures as a PWP?

What is clinical governance?

Tell me about yourself and why you want to work in mental health?

What are your greatest strengths?

What are your most significant weaknesses?

What experience do you have within the Mental Health sector?

Tell me a time when you worked with other people within the healthcare team to provide an excellent patient or client care?

Explain the situation where you helped to improve people’s lives?

Why should we choose you over the other candidates?

Talk to me through the steps you would follow in dealing with an upset or confused patient or a client who was in your care?

What would you do if you didn’t get on with someone in the mental health team?

Describe a stressful situation at work and how you handled it?

Can you tell who are the practitioners 2 of the Stepped Care model?

On-Demand Accredited Courses

Responsibilities of a psychological wellbeing practitioner

Career opportunities as a PWP

Are the trainee psychological wellbeing practitioner interview questions & answers hard?

How long is a PWP interview?

Is PWP an excellent job?

Like This Article?

Get the Reddit app

How to write an introduction for a personal statement for a psychological well-being practitioner diploma/employment role

Enter the 6-digit code from your authenticator app

Enter a 6-digit backup code

Reset your password

Check your inbox

Choose a Reddit account to continue

Psychological wellbeing practitioner

Life as a psychological wellbeing practitioner

Valeria Souza

How much can I earn?

How about the benefits?

Must-have skills

Entry requirements

How to become a psychological wellbeing practitioner

Where a career as a psychological wellbeing practitioner can take you

Progression from PWP to high intensity cognitive behavioural therapy training

Live vacancies

Find a vacancy

Psychological Wellbeing Practitioner (PWP) - Band 5