National Coverage Analysis (NCA) View Public Comments

Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection

Public Comments

Commenter Comment Information
Brooks, Benjamin Title: Associate Director of Policy and Education
Organization: Whitman-Walker Institute
Date: 08/11/2023
Comment:

Whitman-Walker Health is pleased to submit these comments in support of a National Coverage Determination for PrEP for HIV for Medicare. Whitman-Walker supports a national coverage determination (NCD) for Pre-Exposure Prophylaxis for HIV (PrEP), as a prevention modality consisting of a combination of provider-administered services and oral and injectable medications.

Interest and Expertise

Whitman-Walker Health is a Federally Qualified Health Center (FQHC) serving greater

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Hughes, John Title: Director, Federal Policy
Organization: Merck
Date: 08/11/2023
Comment:

August 11, 2023

Rachel Katonak, Lead Analyst
Carl Li, M.D., Lead Medical Officer
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services

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Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection

Dear Ms. Katonak and Dr. Li,

I am writing to express Merck’s support for the National Coverage Analysis

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Wang, Tim Title: Director of Policy and Advocacy
Organization: Howard Brown Health
Date: 08/11/2023
Comment:

Howard Brown Health is a federally qualified health center and the largest LGBTQ+ health center in the Midwest, serving over 35,000 patients across 11 clinic locations in Chicago, Illinois. We provide comprehensive, high quality and affordable care—including primary care, behavioral health, HIV/STI prevention, and sexual and reproductive healthcare—to all patients, regardless of their ability to pay or insurance coverage status. About 16% of our patient population is living with HIV and

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Okpala, Laura Organization: Gilead Sciences
Date: 08/11/2023
Comment:

August 11, 2023

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Rachel Katonak and Carl Li, M.D.
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attention: CAG-00464N
P.O. Box 8013
Baltimore, MD 21244–1850

Re: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection– CAG-00464N

Dear Ms. Katonak and Dr. Li:

Gilead

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Telew, Bekah Title: Co-Executive Director
Organization: Seattle's LGBTQ+ Center
Date: 08/11/2023
Comment:
Since 2013, Seattle's LGBTQ+ Center has provided Pre-Exposure Prophylaxis (PrEP) as a prevention tool for individuals at higher risk of contracting HIV who are not insured and/or connected to the healthcare system. As an organization dedicated to the health and wellness of Black, Indigenous, People of Color, and LGBTQ+ folks, we strongly support the Centers for Medicare and Medicaid Services (CMS) decision to cover oral and injectable PrEP for Human Immunodeficiency Virus (HIV) prevention. We

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Lasser, Adina Title: Public Policy Manager
Organization: Alliance for Aging Research
Date: 08/11/2023
Comment:

August 11, 2023

Carl Li, M.D.; Lead Medical Officer
Rachel Katonak; Lead CMS Analyst
Coverage and Analysis Group
Centers for Medicare and Medicaid Services, mailstop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

RE: Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (CAG00464N)

Dear Ms. Katonak and Dr. Li:

The nine undersigned organizations appreciate the opportunity to

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Guzman, Adrian Title: Director of Policy and External Affairs
Organization: New York City Department of Health and Mental Hygiene
Date: 08/11/2023
Comment:

To Whom It May Concern:

The New York City Department of Health and Mental Hygiene (NYC Health Department) submits these comments in response to the U.S. Centers for Medicare and Medicaid Services (CMS) proposal to cover pre-exposure prophylaxis (PrEP) using oral and injectable antiretrovirals approved by the U.S. Food and Drug Administration (FDA) to prevent HIV infection in people at high risk of acquiring HIV.

The NYC Health Department is the largest municipal public

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Hengst, Stephanie Title: Manager, Policy & Research
Organization: The AIDS Institute
Date: 08/11/2023
Comment:

August 11, 2023

Rachel Katonak, Lead Analyst
Carl Li, M.D., Lead Medical Officer Coverage and Analysis Group
Center for Clinical Standards and Quality Centers for Medicare & Medicaid Services

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Dear Ms. Katonak and Dr. Li:

The 32 undersigned members of the HIV Health Care Access Working Group, the HIV Prevention Action Coalition, and the Federal AIDS Policy Partnership include HIV medical providers, public health

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Postal, Steven Title: Director, Policy and Regulatory Affairs
Organization: NCPA
Date: 08/11/2023
Comment:

Director Jensen,

The National Community Pharmacists Association (NCPA) writes today to provide feedback on CMS’ National Coverage Analysis (NCA) and Proposed Decision Memo: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection.

NCPA represents America’s community pharmacists, including 19,400 independent community pharmacies. Almost half of all community pharmacies provide long-term care services and play a

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Vasquez, Luis Title: Senior Legal Writer
Organization: Human Rights Campaign
Date: 08/11/2023
Comment:

To Whom It May Concern,

On behalf of the Human Rights Campaign’s more than three million members and supporters nationwide, we write in response to the Proposed Decision Memo issued by the Centers for Medicare and Medicaid Services (CMS) outlining its Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention.

The Human Rights Campaign (HRC) is America’s largest civil rights organization working to

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McLean, Rachel Title: Chief, Policy and Viral Hepatitis Prevention
Organization: California Department of Public Health, Sexually Transmitted Diseases Control Branch
Date: 08/11/2023
Comment:

Dear CMS,

CAG-00464N

Thank you for the opportunity to submit public comment on the draft National Coverage Analysis, Proposed Decision Memo (also known as a draft National Coverage Determination, or NCD) regarding Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. Coverage of PrEP has the potential to contribute to ending the HIV epidemic in the United States and California, and I applaud CMS’s decision to

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Cox, Cece Title: CEO
Organization: Resource Center`
Date: 08/11/2023
Comment:

Dear Ms. Katonak and Dr. Li:

I write on behalf of Resource Center, the primary LGBTQIA+ community center in North Texas. We are one of the largest LGBTQIA+ community centers in the United States and our programs serve more than 60,000 people in the community each year. Our work as a direct-service HIV/AIDS healthcare provider stretches back nearly 40 years to the beginning of the HIV/AIDS pandemic and we are the home of a Preexposure Prophylaxis (PrEP) Care Program to reach those

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Thibault-Sennett, Sarah Title: Senior Director, Reimbursement Policy
Organization: American Clinical Laboratory Association (ACLA)
Date: 08/11/2023
Comment:

**Please note that a PDF copy of these comments were submitted over email to Rachel.katonak@cms.hhs.gov to ensure that the foot-notes and red-line edits are understandable.**

August 11, 2023

Dr. Joseph Chin
Deputy Director, Chief Medical Officer, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed National Coverage Determination for

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Kishi, Don Title: PharmD, President
Organization: CSHP Foundation
Date: 08/11/2023
Comment:

August 10, 2023

On behalf of the California Society of Health System Pharmacists (CSHP) Foundation for Research and Education. We are writing to express our support of the CMS Decision Memo on Preexposure Prophylaxis (PrEP) Utilizing Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. We respectfully request that CMS explicitly include the term “pharmacists” among the healthcare professionals mentioned in the current draft document. The memo is a

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Bertani, Scott Title: RE: Pre-Exposure Prophylaxis (PrEP) for Human Immu
Organization: HealthHIV
Date: 08/11/2023
Comment:

August 11, 2023

Carl Li, M.D.
Lead Medical Officer

Rachel Katonak
Lead CMS Analyst

Coverage and Analysis Group

Centers for Medicare and Medicaid Services, mailstop: S3-02-01
7500 Security Blvd.
Baltimore, MD 21244

RE: Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (CAG00464N)

Dear Ms. Katonak and Dr. Li:

HealthHIV & The National Coalition for LGBTQ Health together strongly

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Jones, Greg Title: Executive Director
Organization: CVS Health, Government Affairs
Date: 08/11/2023
Comment:

August 11, 2023

Submitted via: Medicare Coverage Database

Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Dear Administrator Brooks-LaSure:

RE: Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (CAG-00464N)

Thank you for the opportunity to comment on the Proposed National

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Rivera, Ado Date: 08/11/2023
Comment:
I am happy that CMS is covering pre-exposure prophylaxis for HIV prevention. I am also happy to see that CMS recognizes that PrEP provision is not just the dispensation of medications but is a complete service delivery package that entails additional laboratory testing and counseling. Notably, CMS cited the CDC and/or USPSTF guidelines that recommended tests for renal function, lipid levels, and other infections (e.g., Hepatitis B, bacterial sexually transmitted infections). It seems, however,

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Regal, Christopher Title: Director, Clinical Innovation
Organization: AHIP
Date: 08/11/2023
Comment:

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection (CAG-0046N)

Dear Ms. Syrek Jensen:

AHIP appreciates the opportunity to provide input on the Centers for Medicare & Medicaid Services

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Cobb, John Title: Director
Organization: COEDD Area Agency on Aging
Date: 08/11/2023
Comment:
The use of preventative medicine in addressing the HIV/AIDS crisis is saving lives and reducing the long-term cost of treating those who have contracted HIV. It is, in my opinion, not only morally required, but fiscally responsible to cover these medications.
Hoffman, Charlotte Title: Senior Policy Counsel
Organization: National Center for Transgender Equality
Date: 08/11/2023
Comment:

The National Center for Transgender Equality is pleased to submit these comments in support of a National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent HIV Infection. PrEP is an important prevention modality that consists of a combination of provider-administered services and oral or injectable medications.

Interest and Expertise
Founded in 2003, the National Center for Transgender Equality (“NCTE”) works to improve

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Rodriguez, Jose Title: Associate Director, Public Policy & Advocacy
Organization: On behalf of the Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA)
Date: 08/11/2023
Comment:

August 11, 2023

Rachel Katonak, Lead Analyst
Carl Li, M.D., Lead Medical Officer Coverage and Analysis Group
Center for Clinical Standards and Quality Centers for Medicare & Medicaid Services

RE: National Coverage Determination for Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy for HIV Prevention.

Dear Ms. Katonak and Dr. Li:

The Infectious Diseases Society of America (IDSA) and HIV Medicine Association (HIVMA) strongly

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Jones, DO, FIDSA, Robert Title: Medical Director, Infectious Diseases
Organization: Quest Diagnostics
Date: 08/11/2023
Comment:

Dr. Joseph Chin
Deputy Director, Chief Medical Officer, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Mail Stop #S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

RE: Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (Draft NCD 210.15)

Dear Dr. Chin,

Quest Diagnostics is pleased to submit these written comments on the

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Ransone, Jr., MD, FAAFP, Sterling Title: Board Chair
Organization: American Academy of Family Physicians
Date: 08/11/2023
Comment:

August 10, 2023

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
Baltimore, MD 21244

Re: Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (NCD 210.15)

Dear Ms. Jensen:

On behalf of the American Academy of Family Physicians (AAFP), representing 129,600 family physicians and medical students across

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Lesieur, Matthew Title: Co-Chair, Joint Policy Committee
Organization: Joint Policy Committee of the NY HIV Prevention Planning Group and the NY HIV Planning Council
Date: 08/11/2023
Comment:

August 11, 2023

Tamara Syrek-Jensen, JD
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore MD 21244

Subject: Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus ((HIV) Infection Prevention (CAG-00464N)

Dear Ms. Syrek-Jensen:

On behalf of the

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Hilliard, Bobby Title: CEO
Organization: Legacy Community Health
Date: 08/11/2023
Comment:

On behalf of Legacy Community Health, we appreciate the opportunity to provide input regarding Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection; CAG-00464N.

As one of the nation’s largest Ryan White clinics and full-service Federally Qualified Health Centers (FQHC) based in Houston, Texas, Legacy identifies unmet needs and gaps in health-related services and develops client-centered programs to address those needs.

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Metzner, PharmD, AAHIVP, Aimee Title: Director, Health Outcomes
Organization: ViiV Healthcare
Date: 08/10/2023
Comment:

August 11, 2023

ViiV Healthcare
410 Blackwell Street
Durham
North Carolina USA
27701

VIA ELECTRONIC SUBMISSION: CMS.gov

Tamara Syrek Jensen, JD, Director
Joseph Chin, MD, Deputy Director
Coverage and Analysis Group (CAG)
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard Baltimore, MD 21244
CC:
Rachel Katonak, Lead Analyst
Carl Li,

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Van Wagoner, Nicholas Title: Co-Chair, NNPTC
Organization: National Network of STD Clinical Prevention Training Centers
Date: 08/10/2023
Comment:

This public comment is made on behalf of the National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC). The NNPTC is funded through the Centers for Disease Control and Prevention (CDC) to assist clinicians in the United States with the skills, knowledge, and experience needed to address and prevent sexually transmitted infections (STI) in their patients. The NNPTC is composed of national, regional, and local clinicians, educators, leaders in public

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Schmid, Carl Title: Executive Director
Organization: HIV+Hepatitis Policy Institute
Date: 08/10/2023
Comment:

August 10, 2023

Rachel Katonak, Lead Analyst
Carl Li MD, Lead Medical Officer
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Mailstop S3-02-01
7500 Security Boulevard
Baltimore MD 21244

Subject: Medicare National Coverage Determination for Pre-Exposure Prophylaxis Using Antiretroviral Therapy to Prevent HIV Infection

Dear Ms. Katonak and Dr.

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Richgels, Carrie Title: Manager of Policy and Advocacy
Organization: Fenway Health
Date: 08/10/2023
Comment:

Dear Tamara Syrek, Joe Chin, and the Coverage Analysis Group,

Fenway Health is a federally qualified health center and Ryan White Part C HIV clinic in Boston, MA that serves 35,000 unique patients each year. Half of our patients are LGBTQIA+, and about 5400 are transgender and nonbinary. About 2,300 of our patients are people living with HIV, and we have more than 3,500 patients currently taking PrEP for HIV prevention.

We submit comment in strong support of the proposal

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Deitch, Rachel Title: Director, Federal Policy
Organization: National Coalition of STD Directors
Date: 08/10/2023
Comment:

Thank you for the opportunity to submit this comment on behalf of the National Coalition of STD Directors (NCSD). NCSD represents the governmental public health leaders administering sexually transmitted infection (STI) prevention programs in all fifty states, three territories, and six major cities. Our members are deeply invested in ensuring increased access to HIV PrEP as a key component of ending the HIV epidemic. In their work implementing CDC guidelines on PrEP, PrEP is not simply a

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Frochtzwajg, Jonathan Title: Public Policy & Grants Manager
Organization: Cascade AIDS Project
Date: 08/10/2023
Comment:

I am writing on behalf of Cascade AIDS Project (CAP), the oldest and largest HIV-services provider in Oregon and Southwest Washington, to express our support for the Center for Medicare and Medicaid Services’ (CMS’s) proposal to cover the cost of Pre-Exposure Prophylaxis (PrEP) for people who receive Medicare benefits.

As the National Coverage Analysis (NCA) points out, in 2019, more than 10% of new HIV infections occurred among people 55 years and older, and between 2015 and

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Tassi, Tanya Title: Director of Policy and Advocacy
Organization: CenterLink: The Community of LGBTQ Centers
Date: 08/10/2023
Comment:

CenterLink is a nonprofit organization based in Florida with a mission to grow, strengthen, and connect LGBTQ community centers through leadership development, technical assistance, training, capacity building, and more. Our member centers serve a total of 2.7 million people each year, including many who would otherwise lack equitable access to services relating to health, housing, social support, education, employment, and more. In addition to the direct services they provide, LGBTQ

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Johnson, Danielle Title: Registered Nurse
Date: 08/10/2023
Comment:

Oral Preexposure Prophylaxes (PrEP) was approved in July 2012, and Injectable PrEP was approved in July 2021. However, the uptake of PrEP in the community and providers has been slow due to multiple barriers. One of those barriers is the cost of the medication for those with and without insurance. (Marks et al., 2017; Unger et al., 2022; Zhang et al., 2018)

I support CMS’s proposed changes to increase coverage for oral and injectable PrEP, but more should also be considered.

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Simon, Kayla Title: Director of Programs
Organization: Bradbury Sullivan LGBT Community Center
Date: 08/09/2023
Comment:

Bradbury-Sullivan LGBT Community Center is a nonprofit organization based in Allentown, PA with a mission to foster a community who demands equity and creates pathways for LGBTQ+ people to thrive and experience Queer joy. Our center has and plans to continue to provide free HIV testing to our community. We also provide education about PrEP and its benefits to community members. We have trained physicians on the importance of providing LGBTQ-affriming sexual healthcare, especially when it

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Kelly, Kaitlyn Title: Senior Policy Advisor
Organization: Representative Adam B. Schiff
Date: 08/09/2023
Comment:

Dear Administrator Brooks-LaSure,

We write to express strong support for the Centers for Medicare and Medicaid Services (CMS) announcement on July 12, 2023, regarding the Proposed National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention. This proposed rule takes critical steps to ensure that Medicare beneficiaries have access to both daily oral and long-acting PrEP medication without the burden of

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Christ, Amber Title: Managing Director, Health Advocacy
Organization: Justice in Aging
Date: 08/08/2023
Comment:

Comment in Support of the proposed CMS National Coverage Determination (NCD) to allow coverage under Medicare Part B for provider-administered PrEP to Prevent HIV Infection (CAG-00464N)

Justice in Aging and the Medicare Rights Center strongly support the proposed National Coverage Determination (NCD) issued on July 12, 2023, that would provide Medicare Part B coverage for Preexposure Prophylaxis (PrEP) to individuals Using Antiretroviral Therapy to Prevent Human Immunodeficiency

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Murphy, Michael Title: Advisor for State Government Affairs
Organization: American Pharmacists Association
Date: 08/08/2023
Comment:

August 8, 2023

Tamara Syrek Jensen, JD, Director
Joseph Chin, MD, Deputy Director
Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention

Dear Director Syrek Jensen and Deputy Director

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Tolley, Robert Title: FNP-BC
Date: 08/05/2023
Comment:

I urge CMS to make the adjustment to the National Coverage Determinations Manual and ensure PrEP coverage parity across private insurance and Medicare Part A and Part B.

It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling.

I urge CMS to adopt periodic sexually transmitted infection (STI) screening and renal function assessments as outlined in the Centers for Disease

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Welbeck, Monique Date: 08/04/2023
Comment:
Allow patients to receive administration of LAI PreP from pharmacists. Provider can order LAI medication but allow patients to rececive administration from pharmacists. This will improve access, eliminate barriers. HIV RNA should be covered (not just ab/ag) to eliminate barriers to LAI PrEP.
STI testing frequency should be increased to be more than once a year and include extragenital.
Frosst, Phyllis Title: Director, Global Policy
Organization: Johnson & Johnson
Date: 08/04/2023
Comment:

August 4th, 2023
Rachel Katonak and Carl Li, M.D.
Coverage and Analysis Group
Centers for Medicare & Medicaid Services
U.S. Department of Health and Human Services
Attention: CAG-00464N
P.O. Box 8013
Baltimore, MD 21244–1850

RE: Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection

Dear Ms. Katonak and Dr. Li:

Johnson & Johnson (“J&J”) is pleased to submit the

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barnhart-hinkle, blair Title: Director, Government Relations
Organization: Cleveland Clinic
Date: 08/03/2023
Comment:
We agree with the CMS decision to offer Pre-Exposure Prophylaxis (PrEP) with effective antiretroviral therapy (ART) to persons at high risk of Human Immunodeficiency Virus (HIV). In addition, we urge CMS to include STD testing and hepatitis screening as a part of the care provided with PrEp. Thank you for your consideration of our feedback.
Hendershot, Shawn Date: 08/03/2023
Comment:
Not only should this be covered under Medicare parts A and B, the private companies should be compelled to pay all costs as well. After all, PrEP is healthcare, and Injectable PrEP is a lifesaver for those of us who hate to be scheduled.
Church, Ellen Date: 08/03/2023
Comment:
Our tax dollars must ensure the latest medical therapies are available to all. In my lifetime, I have witnessed and feared the impact of HIV. PrEP is an impressive and extremely useful therapy that should be fully funded for those who elect to use it. I implore you to support the funding of PrEP.
Kwong, Jeffrey Title: Nurse Pracitioner & Professor
Organization: Rutgers School of Nursing
Date: 08/02/2023
Comment:
As a frontline HIV provider, educator, and advocate, I strongly support the decision by CMS to cover all forms of PrEP and the associated testing as recommended by the CDC guidelines and the USPSTF. I provide care to a large proportion of individuals at risk of HIV who are over the age of 65. By providing coverage for these services CMS can help reduce barriers to care and help end the HIV epidemic.
Thompson, Victor Date: 08/02/2023
Comment:
Make sure to also cover Post Exposure Prophylaxis
GYSIN, DAVE Title: HIV Specialized Pharmacist
Organization: OptiMed Pharmacy
Date: 08/02/2023
Comment:
“We urge CMS to make the adjustment to the National Coverage Determinations Manual and ensure PrEP coverage parity across private insurance and Medicare Part A and Part B.”
“It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling.”
“We urge CMS to adopt periodic sexually transmitted infection (STI) screening and renal function assessments as outlined in the Centers for Disease

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De Martini, Loriann Title: PharmD, BCGP, MPH Chief Executive Officer
Organization: CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS (CSHP)
Date: 08/01/2023
Comment:

On behalf of the California Society of Health System Pharmacists (CSHP), I am writing to express our support for the CMS Decision Memo on Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. We ask that CMS explicitly include ‘pharmacists’ as one of the health care professionals mentioned in the current draft document. The memo represents a crucial step forward in combating the spread of HIV and improving public health

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Lombard, Ronald Title: APN
Date: 07/31/2023
Comment:
I support expanding access to PrEP and limiting patient barriers to access PrEP. PrEP helps prevent HIV infections. Easier access to and less barriers obtaining PrEP are crucial factors in the fight to decrease new HIV infections. I recommend that PrEP and PrEP related visits (counseling and testing) be paid for by CMS.
Thank you
Beesley, Brian Title: Medical Director
Organization: AHF Columbus
Date: 07/31/2023
Comment:
I urge CMS to make the adjustment to the National Coverage Determinations Manual and ensure PrEP coverage parity across private insurance and Medicare Part A and Part B. It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling. I urge CMS to adopt periodic sexually transmitted infection (STI) screening and renal function assessments as outlined in the Centers for Disease Control and

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Shea, Erika Title: CRNP
Organization: Congreso
Date: 07/30/2023
Comment:

Hello, PrEP of all forms, in all ways possibly administered, needs to be easily accessible to all who need it. Some patients are septuagenarians when diagnosed with HIV. Apretude and Cabenuva have revolutionized HIV prevention and treatment, and this needs to continue with medications in the pipeline, namely Lenacaprevir. Septuagenarians often have co-morbidities such as chronic kidney disease. Many patients do not want 2 injections in their hips every 2 months. Having a self-injectable

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Minama Reddy, Geeth Kavya Title: MD
Date: 07/30/2023
Comment:
Dear CMS, I am a family physician who provides HIV care, PrEP, and primary care at a federally-qualified health center located in a neighborhood of Boston that is disproportionately impacted by new HIV diagnoses. PrEP is vital in eliminating these disparities and achieving the nation's goal of ending the HIV epidemic by 2030. Based on recent data from AIDSVu, Black people made up 42% of new HIV diagnoses, but only made up 14% of individuals prescribed PrEP. These disparities continue for other

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Singh, Tulika Date: 07/30/2023
Comment:
“We urge CMS to make the adjustment to the National Coverage Determinations Manual and ensure PrEP coverage parity across private insurance and Medicare Part A and Part B.”
“It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling.”
“We urge CMS to adopt periodic sexually transmitted infection (STI) screening and renal function assessments as outlined in the Centers for Disease

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Boswell, Kristie Title: FNP
Date: 07/29/2023
Comment:
I urge CMS to make the adjustment to the National Coverage Determinations Manual and ensure PrEP coverage parity across private insurance and Medicare Part A and Part B. It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling. I urge CMS to adopt periodic sexually transmitted infection (STI) screening and renal function assessments as outlined in the Centers for Disease Control and

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Sylla, Laurie Date: 07/28/2023
Comment:

Hello
As a professional working in the HIV/AIDS field for the past 40 years, I applaud CMS's decision to recommend Medicare coverage of ALL FDA-approved PrEP medications and accompanying lab screening.

Laurie Sylla
Mountain West AETC

Thomas, Elaine Title: MD
Date: 07/28/2023
Comment:
It is critical to cover all expenses related to PrEP (as well outlined by other commenters) for all adults and adolescents who need it, without artificial restrictions as to "high risk" (and providers should not have to use stigmatizing diagnoses such as "high risk sexual behavior"). PrEP is highly efficacious and has not yet reached those most at risk. Health care providers (not only MDs) and public health providers should be enabled and encouraged to use PrEP as part of HIV prevention.

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Rymland, Emily Title: Director of Clinical Care
Organization: Q Care Plus
Date: 07/28/2023
Comment:
I have been an HIV provider for many years. When PrEP was developed, it was extraordinary and it is changing lives and it is saving lives. I wanted to express my support for this initiative to ensure that PrEP is accessible to all.
Thank you
Dees, Abigail Date: 07/28/2023
Comment:
I am for Medicare covering PrEP. It is a vital tool in HIV prevention and should be available to as many people as possible.
Ayala, Jonathan Title: Associate Manager
Organization: NMAC
Date: 07/28/2023
Comment:
We have begun to hear stories from advocates in places like Wilton Manors, Palm Springs, and other enclaves with large numbers of older queer men, that the lack of specific PrEP outreach to these folks has resulted in several men older than 65 acquiring HIV. We know that PrEP works very well at preventing HIV acquisition if taken correctly. We also know that older adults have sex. CMS should cover preventative PrEP services to begin dismantling barriers for older adults to healthy living.
Lake, Adam Title: Program Director for Marginalized Populations
Organization: Penn Medicine/LG Health
Date: 07/28/2023
Comment:

I am certainly in favor of clear coverage provisions:
We need coverage of gonorrhea, chlamydia, and syphilis testing at least every 3 months and as needed.
We need clarity on coverage for mycoplasma genitalium testing, as this is an emerging pathogen of concern.
Wood GE, Bradshaw CS, Manhart LE. Update in Epidemiology and Management of Mycoplasma genitalium Infections. Infect Dis Clin North Am. 2023 Jun;37(2):311-333. doi: 10.1016/j.idc.2023.02.009. PMID:

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Navracruz, Lisa Title: Family Physician
Date: 07/28/2023
Comment:
This proposal is a step in a very good direction— there are few if any prevention interventions that have the evidence of efficacy and impact that HIV PrEP has. However, the coverage needs to expand to regular screening for multi-site STIs and renal function— as determined by the prescriber, not a third party. (Some patients will need these screenings more frequently, some less frequently, and the prescriber shouldn't have to fight for appropriate care.) CMS should also fight to

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meyers, William Title: Clinical Pharmacist
Organization: AMERICAN ACADEMY OF HIV MEDICINE
Date: 07/27/2023
Comment:
I encourage you to support coverage of PREP as a very important step in preventing the spread of HIV to uninfected individuals
Barnes, Dana Title: MD
Date: 07/27/2023
Comment:
It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling.
Without explicit coverage requirements for evidence-based follow-up care that includes critical STI screening and tests for renal function, disparities undoubtedly will occur based on the type of insurance coverage a person has.
Axelsson, Fiona Title: MD
Date: 07/27/2023
Comment:

I am in in 100% of the following:

We urge CMS to make the adjustment to the National Coverage Determinations Manual and ensure PrEP coverage parity across private insurance and Medicare Part A and Part B.

It is imperative that CMS include coverage of recommended follow-up care for persons utilizing PrEP that goes beyond HIV testing and mental health counseling.

We urge CMS to adopt periodic sexually transmitted infection (STI) screening and renal function

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Phoenix, John Title: APRN
Organization: Huntridge Family CLinic
Date: 07/27/2023
Comment:
Coverage needs to include payment for the STI labs for 3 site testing as appropriate.
Coverage needs to include routine screening for Hepatitis C, based on risk
Coverage needs to include point of care testing for HIV and Hepatitis C
Coverage needs to include payment for the provision of injection services, CPT 96372
Coverage needs to include payment for the venipuncture services, CPT 36415
Coverage needs to include payment for HIV RNA testing every 2 months as listed

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Richmond, David Title: Dr.
Organization: HIV Alliance
Date: 07/26/2023
Comment:
Expanding PrEP services in this manner should facilitate faster and more appropriate uptake of effective ART to those in need of it. This should result in decreasing HIV transmission and take us a step further in ending HIV. Therefore, on behalf of HIV Alliance, we support this proposal.
Bowlware, Rhonda Date: 07/26/2023
Comment:
I completely support and encourage PrEP being moved to a preventative class which which will enable the treatment to become affordable for Medicare Beneficiaries. Currently there are many programs that provide financial assistance for people at risk of HIV. None of these programs are able to help those on Medicare. Those at risk for HIV can obtain PrEP for free except those on Medicare where the costs are incredibly high and not affordable. Moving PrEP to preventative class will provide

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Knapp, Lindsey Date: 07/25/2023
Comment:
As a medical provider in NYS I can say definitively that it is in the best interest of Americans on Medicare and in the best interest of our community, country, and even the entire world that CMS cover all forms of pre-exposure prophylaxis for the prevention of HIV. End the PANDEMIC. CMS has the ability to make a difference and they should take every opportunity to do so.
Lustig, Robert Date: 07/24/2023
Comment:
I believe that PreP coverage by Medicare is entirely appropriate as advised by the task force to provide exactly the same coverage as is currently provided to all individuals under age 65. It is an essential component of HIV prevention for an individual and through reduction of transmission to HIV to others and therefore there should be no delay in providing full coverage of PreP by Medicare.
Leviashvili, Sean Date: 07/22/2023
Comment:

YES! Please support the expansion of Prep access to individuals at risk. This preventative medication is a life changer and is vital to our fight, as a society and as a world, against HIV/AIDS. We must continue to expand access!!! I can't stress it enough how important it is that all individuals who are determined to be at risk have access to this vital medication. We actually have a chance at eradicating HIV/AIDS at some point if we continue to expand access and coverage - let's not mess

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Newcomb, Joseph Title: Medical Office Associate
Organization: UICOMP/PHS
Date: 07/21/2023
Comment:
Joseph Newcomb support that medicare payed for NCA-Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Preven Human Immunodeficiency Virus (HIV) Infection (DAG-004464N) )
Berger, Mitchell Title: Public Health
Organization: commenting in personal capacity
Date: 07/20/2023
Comment:

To whom it may concern:

I write to support Medicare coverage of pre-exposure prophylaxis (PrEP). In support of this I note the following:

A. Consistency with HIV/AIDS Policy: This effort is consistent with goals of the Ending the HIV Epidemic in the US initiative, including early initiation of antiretroviral strategies and support for evidence-based interventions and strategies

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Childs, Katie Title: Social Worker
Organization: UW Health
Date: 07/17/2023
Comment:
A change by CMS to cover PrEP medication, its administration, and Hep B testing will not improve access to PrEP unless the CMS also covers the other lab tests that are a recommended part of all PrEP care. These other labs include HIV testing STI testing at least four times a year and other labs to monitor kidney function as needed. PrEP has transformed the lives of many by providing accessible, highly effective HIV prevention. If patients are responsible for the costs of these other labs, it

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Mattox, Chera Date: 07/17/2023
Comment:
I am writing this comment in favor of CMS supporting PrEP for all participants who request it, not just for those with higher risk as that falls short of best practice. There are record numbers of patients who have STIs and since the introduction of Viagra the number has increased specifically in the older population. In addition, having PrEP as an option will decrease the amount infections while the US continues to address the opioid epidemic that has ravished communities.
Flanagan, Scott Title: Director of Ambulatory Pharmacy
Organization: Southcoast Health
Date: 07/17/2023
Comment:

My comment is not to address whether or not PrEP should be covered, but rather HOW Medicare pays for products and therapies. Medicare is the only third party payer that complicates patient access to their therapies by restricting some drugs (and vaccines) to Part B versus Part D. The Medicare Part B rules are so cumbersome that many pharmacies have opted out, leaving patients with less choice in where they receive life saving therapies.

Take diabetic testing supplies as an

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Bundy, Joshua Title: Director
Organization: Damien Center
Date: 07/16/2023
Comment:

I applaud CMS for considering the addition of both the oral and injectable versions of PrEP, labs, and office visits to beneficiaries receiving Medicare. Adding this service will undoubtedly improve the health and well being of Medicare beneficiaries by providing a highly effective and cost saving prevention tool to providers. We also believe that this preventative tool will decrease the cost to Medicare overtime by preventing new HIV infections and reducing the number of beneficiaries

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Volkerding-Trinka, Jennifer Title: RN/BSN/Clinical Services Director
Organization: Cape Girardeau County Public Health Center
Date: 07/14/2023
Comment:

The Health Center offers a health clinic for those seeking PrEP. Through the Ending the HIV Epidemic project we were finally able to start a PrEP Clinic. I truly believe that the ONLY way to stop HIV and end the HIV epidemic and reduce the cost burden for the actual medical care for those who become + for HIV is to provide everyone who considers themselves at risk for becoming infected with HIV the opportunity to receive PrEP. All insurance companies, including Medicare, should include

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Beal, Jeffrey Title: M.D.
Date: 07/14/2023
Comment:
I strongly encourage and support the decision to provide and pay for all PrEP modalities by Medicare. Yes do include injectable options.
Floyd, Carly Date: 07/13/2023
Comment:

Prior to injectable PrEP, an HIV RNA test should be covered (not just an HIV ab/ag) as this needs to be ordered within a week of injectable PrEP initiation to confirm HIV negative status. As an HIV prevention provider, getting coverage for the HIV RNA has been one of the biggest hurdles people have to injectable PrEP access. Additionally, sexually transmitted infection (STI) testing (urine and extragenital) should be covered at the same frequency as HIV testing. We know that HIV and STIs go

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Sanders, Nick Title: Senior Prevention Program Manager
Organization: Damien Center
Date: 07/13/2023
Comment:

Please consider adding PrEP (for HIV Prevention) on as a covered service (for lab, office visit and medication coverage). PrEP can a life-saving medication to help significantly decrease potential risk to HIV in the state of Indiana and across the country. I work with so many indivuals that want to get on PrEP to take control of their health and decrease HIV exposure but struggle because it's not believed that PrEP is accessible to the general Public.

PrEP is a prime example of

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Hirsch, Ronald Title: MD
Date: 07/12/2023
Comment:
I fully suppport this proposal. As a physican who treated HIV during the 1980s and 1990s, I saw the tragic consequences of HIV and AIDS. The ability to prevent infection without cost barriers would be so important.