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

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 Washington, DC's diverse urban community, including individuals who face barriers to accessing care, and with a special expertise in HIV care and serving lesbian, gay, bisexual, transgender and questioning/queer (LGBTQ) populations. Whitman-Walker has been a nationally recognized leader in LGBTQ+ community health for almost four decades. In calendar year 2022, we provided health care to over 16,000 patients. In 2022, about 50% of our patients identified as Lesbian, Gay, or Bisexual and 15% as Transgender. Whitman-Walker Health received the National Committee for Quality Assurance’s (NQCA) Patient-Centered Medical Home (PCMH) Recognition. This recognition shows Whitman-Walker uses evidence-based and patient-centered processes to serve patients. These practices focus on highly coordinated integrated care and building long-term relationships between patients and their care team. Whitman-Walker’s medical teams are recognized at the highest level of this recognition at all our center sites.

Whitman-Walker has been a nationally recognized leader in HIV treatment and prevention for four decades. In calendar year 2022, we provided health care to 3,147 people living with HIV. We serve about 25% of the District of Columbia’s reported HIV-positive population, many of whom are low-income or members of otherwise underserved communities. In 2022, eighty-three (83) percent of all our patients living with HIV are virally suppressed – a success rate much higher than the national and DC averages for people living with HIV, and comparable to the success rate for Ryan White-funded programs. Early program data suggests even higher rates of viral suppression for patients using injectable ARTs, demonstrating the high effectiveness of injectable modalities.

In 2022, we provided rapid HIV tests to 7,569 individuals, 2,931 of our patients received a PrEP prescription, and 853 patients were served by our low barrier PrEP Clinic. Our walk-in Sexual Health and Wellness clinics and field-testing van, which offer STI and HIV testing, served 1,753 individuals. Whitman-Walker’s innovative PrEP clinic, founded in 2015, uses a red-carpet style program to facilitate same or next-day PrEP access. Our PrEP clinic has served 1,457 patients since 2017, with many patients able to receive PrEP within an hour. Our health care providers provided PrEP prescriptions for many more patients directly.

Comments on the Proposed Determination
We strongly support the national coverage determination of the HIV prevention modality, PrEP. As CMS notes, PrEP is a modality of biomedical and biopsychosocial interventions.

Organizational Sustainability Requires Coverage for Services and Medication
We recommend CMS NCD approve PrEP’s attendant services without cost sharing under Medicare Parts A & B and require coverage of PrEP medications under Medicare’s Part D drug coverage without beneficiary cost sharing.

Community health center operations and non-profit health providers generally operate with narrow financial margins. Due to the high cost of name-brand oral and injectable PrEP, they must have coverage and assurance of reimbursement to provide this treatment and medications. For example, Apretude’s retail price is nearly $4,000 per injection. The ability to secure this and oral medications through Medicare Part D prescription drug plans is critical for cash flow and smooth operations. When the medications are covered under Part B, the health center must buy the medications and then submit a claim including the medication and wait for reimbursement. For FQHCs who are paid through the Prospective Payment System (PPS, a predetermined fixed amount based on previous year’s cost report), this fixed rate payment means that FQHCs have no option to include the high-cost medication for reimbursement through Part B and it would be financially devastating and not feasible. Ensuring medication – even injectables – are covered through Medicare Part D is critical to the ability for health centers to provide these services and remain financially viable. Without coverage in Part D, the cost of drug acquisition would be devastating to health center operations and impede efforts to scale PrEP uptake in underserved communities.

Enumerate All Covered Services for PrEP Modality
We concur with CMS that the evidence prepared for the USPSTF recommendation on PrEP with ART demonstrates efficacy and safety for persons who are at high risk of HIV. As well, we recommend for CMS NCD screening eligibility criteria guidelines to align their language concerning ‘high risk’ determination to CDC’s guidelines indicating “PrEP use for sexually-active persons,” instead of restricting the criteria solely to ‘high risk individuals.’ The small harms that exist are mitigated through ongoing risk assessment counseling and monitoring for safety; including HIV screening and STI screening for chlamydia, gonorrhea, and syphilis, kidney function and lipid testing. CMS’ determination includes seven HIV screens, one HBV screen, and seven individual counseling visits every 12 months. We strongly recommend that CMS include in the final NCD up to four STI panel screenings, which should cover quarterly chlamydia, gonorrhea, and syphilis screens; annual kidney function assessments, measured by creatine ratio; pregnancy tests, and annual urine glucose and urine protein assessments, per year. There should also be specificity added to the HIV screening recommendations to allow for viral load screening and assessment. Including these screenings and assessments would bring CMS’ coverage into alignment with the CDC’s recommendations and USPSTF recommendations.[1] We also support the inclusion of an exception for coverage of additional PrEP-related screenings and counseling services when deemed medical necessary by an enrollee’s provider.

CMS identifies that the laboratory screenings and ongoing monitoring are covered for beneficiaries and may be ordered at the discretion of the health care provider.[2] We recommend that CMS explicitly name in the text of the NCD the recommended and covered laboratory screenings and ongoing monitoring assessments identified above. It is our experience that many practitioners benefit from the additional information on the standard of care for people at high risk of HIV acquisition.

Currently, community pharmacies can improve patient adherence and retention in treatment plans through increasing the availability of the medication, supporting the inclusion of clinical staff and community health workers and pharmacy staff in patient care, and ensuring the efficient operation of health centers through the contributions of pharmacy income to health center sustainability.

Evergreening the NCD
There are many PrEP with ART products in the development pipeline.[3] While we understand that CMS’ NCD for Medicare parts A and B requires a Grade A or B by the USPSTF, we know that new modalities for HIV prevention are required to end the HIV epidemic, in particular to reach populations of women at high risk for HIV acquisition. As we continue to test new modalities, we recommend that CMS’ approval be inclusive of new and emerging administration methods that receive grade A or B recommendations from the USPSTF in the future.

Conclusion
We appreciate CMS’ work to improve access to PrEP with ART by clarifying Medicare coverage for PrEP services and medications. We urge you to ensure that the nation’s safety net providers are able to implement the prevention modality in a financial sustainable manner by approving services through Medicare Parts A and B and the medications, both oral and injectable, through Medicare Part D. Health centers continue to see beneficiaries experience barriers to PrEP access, including difficulty ensuring that patients are not subjected to cost sharing. Patient cost sharing is a continual barrier to accessing preventive care. The use of 33-billing modifier to denote preventive services remains an operational challenge for many health insurance providers. We believe that the implementation of the ICD code for PrEP will assist with distinguishing prevention from treatment and facilitate payors compliance with the statutory and regulatory prohibitions on patient cost sharing. We look forward to working with CMS in its oversight capacity to ensure that implementation of this NCD for PrEP with ART supports patient access.

Respectfully submitted.

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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

VIA ELECTRONIC SUBMISSION

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 (NCA) for Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy (ART) to Prevent Human Immunodeficiency Virus (HIV) Infection. For over three decades, Merck has been engaged in research and development efforts in the prevention and treatment of HIV. Merck scientists have made significant discoveries that have changed the way HIV is treated, and Merck remains committed to ensuring PrEP is equitably available to all who could benefit.

Of the 1.2 million people in the United States who could benefit from PrEP, only 30% were prescribed and adherent in 2021.(1) The implementation of $0 cost sharing for PrEP products under Medicare Parts A and B is an important step to improve access and to address disparities for populations like dual eligible beneficiaries, a population with demographics that demonstrate they can most benefit from access to and uptake of PrEP.(2) Approximately 48% of dual eligible beneficiaries are non-white compared to 19% of non-dual eligible beneficiaries, mirroring the data on non-white racial and ethnic groups with lower adherence rates highlighted in the proposed decision memo.(3) PrEP is an important tool needed to achieve the goals of the National HIV/AIDS Strategy and the Ending the HIV Epidemic in the United States and is a step toward greater health equity among people most affected by HIV. Merck commends the Centers for Medicare & Medicaid Services (CMS) for concluding that coverage of PrEP products and certain ancillary services without cost-sharing are reasonable and necessary for coverage for individuals entitled to Medicare benefits under Part A or enrolled under Part B.

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 Howard Brown provides a variety of services for people living with HIV (PLWH) and people vulnerable to HIV, including HIV screening, PrEP, case management support, long-term care and medication adherence counseling.

We support the proposed National Coverage Determination for HIV PrEP, including all forms of PrEP. There is substantial evidence that PrEP has a significant benefit in lowering the risk of HIV infection, and it is a critical tool for ending the HIV/AIDS epidemic.

An estimated 1.2 million persons in the U.S. currently live with HIV, and an estimated 30,635 new cases of HIV were diagnosed in the U.S in 2020. There are racial disparities when it comes to rates of new diagnoses, with Black individuals accounting for 42% of new cases and Latinx individuals accounting for 27%. Access to preventive medicine, such as PrEP, is vital to closing these disparities and ending the HIV epidemic. All forms of PrEP have shown to be important tools in preventing the spread of HIV. Oral PrEP was given a Grade A recommendation by the United States Preventive Services Task Force (USPSTF) in 2019 due to substantial evidence that PrEP can reduce the risk of getting HIV from sex by about 99% when taken as prescribed. Long-acting injectable PrEP is also highly effective and critical for ending the HIV epidemic. A 2021 study showed that injectable PrEP was superior to oral medication at preventing HIV infection among MSM and transgender women. This NCD will help to reduce cost barriers and further expand PrEP access. This is especially critical now as cases like Braidwood Management v. Becerra attempt to undermine access to PrEP and threaten to derail progress made in ending the HIV epidemic, particularly for disproportionately affected populations.

We strongly support this proposed National Coverage Determination, and we have the following recommendations to strengthen the NCD and ensure that patients have access to best practice PrEP care.

Due to the financial operations of community health centers, we recommend CMS NCD approve PrEP’s attendant services without cost sharing under Medicare Parts A & B and require coverage of PrEP medications under Medicare’s Part D drug coverage without beneficiary cost sharing. As non-profits, federally qualified health centers (FQHCs) generally operate with very narrow financial margins. Due to the high cost of name-brand oral and injectable PrEP, we must have coverage and assurance of reimbursement to provide this treatment and medications. For example, Apretude’s retail price is nearly $4,000 per injection. The ability to secure this and oral medications through Medicare Part D prescription drug plans is critical for cash flow and smooth operations. When the medications are covered under Part B, the health center must buy the medications and then submit a claim including the medication and wait for reimbursement. For FQHCs that are paid through the Prospective Payment System, this fixed rate payment means that FQHCs have no option to include the high-cost medication for reimbursement through Part B and it would not be financially feasible to provide. Ensuring medication–including injectables–are covered through Medicare Part D is critical to the ability for health centers to provide these services and remain financially viable. Without coverage in Part D, the cost of drug acquisition would be devasting to health center operations and impede efforts to scale PrEP uptake in underserved communities.

We also recommend that CMS clearly enumerate all services covered for PrEP by the NCD. Currently, CMS proposes to cover HIV screening up to seven times annually, and a single screening for hepatitis B virus (HBV). This does not align with the recommendations from the CDC or the USPSTF, which both include routine STI screening and lab testing to monitor overall health outcomes for patients on PrEP. As such, we strongly recommend that CMS include in the final NCD: four STI panel screenings, which should cover quarterly chlamydia, gonorrhea, and syphilis screens; annual kidney function assessments, measured by creatine ratio; pregnancy tests, and annual urine glucose and urine protein assessments. We also recommend that CMS specify that HIV screening recommendations also allow for viral load screening and assessment.

Ensuring patients have access to STI screenings by removing potential cost barriers will help prevent delayed diagnoses, which can also help to prevent onward transmission. Routine renal monitoring is vital in helping to detect and prevent issues related to augmented renal function that may present in long-term PrEP users. This monitoring is especially important for patients who are managing other chronic illnesses, such as hypertension or diabetes. Explicit inclusion of STI screening and renal monitoring in this NCD will help to increase positive health outcomes ensure better overall health of PrEP users.

A National Coverage Determination making all forms of PrEP widely available is an important tool in fighting the HIV epidemic. This determination has the potential to reduce significant cost barriers that many individuals face when attempting to access and adhere to PrEP. Thank you for your consideration, and for allowing us to speak to this important issue. If you need any more information, please do not hesitate to contact Tim Wang, Director of Policy and Advocacy, at timothyw@howardbrown.org.

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August 11, 2023

VIA ELECTRONIC DELIVERY

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

Dear Ms. Katonak and Dr. Li:

Gilead Sciences Inc. appreciates the opportunity to comment on the Proposed Decision Memorandum for the National Coverage Determination (NCD) for coverage of Pre-Exposure Prophylaxis (PrEP) using antiretrovirals for persons at high risk of Human Immunodeficiency Virus (HIV) acquisition released on 07/12/2023. Gilead is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Gilead’s primary areas of focus include HIV/AIDS, liver disease, oncology, cardiovascular/metabolic and respiratory conditions, and inflammatory diseases.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing, linkage to care, and cure research. Gilead researchers have developed twelve HIV medications, including the first single-tablet regimen to treat HIV and the first once-daily oral antiretroviral tablet for PrEP to reduce the risk of acquiring HIV infection through sex. These advances in medical research have helped millions of people living with HIV and those who can benefit from PrEP have longer, more fulfilling lives. We remain committed to continued scientific innovation to better understand and address the evolving needs of this population. Gilead is actively pursuing innovative cures and long-term viral suppression strategies while seeking to optimize antiretroviral regimens and prevention therapies for all individuals impacted by HIV. Gilead also has a longstanding commitment and history of working with federal agencies and local governments to expand access to HIV care and treatment—including innovative HIV treatment and prevention medicines—to achieve our collective goal of ending the HIV epidemic in the United States.

We are aligned with CMS’ proposed determination that the evidence is adequate to conclude that the United States Preventive Services Task Force (USPSTF) recommendation in offering PrEP with effective antiretroviral therapy (ART) to persons at high risk of HIV acquisition with a grade A recommendation, is reasonable and necessary for the prevention or early detection of illness or disability. We also support CMS’ proposed decision to cover approved PrEP medicines using antiretroviral therapy to prevent HIV infection in individuals at high risk of HIV acquisition without cost sharing for Medicare beneficiaries. This, in addition to CMS’ proposed coverage of certain screening and counseling visits, will significantly improve access to PrEP and ancillary services within the Medicare population. We appreciate that CMS is taking this important step to support individuals at risk for HIV acquisition to mitigate the public health impact of HIV in the United States.

With this in mind, Gilead recommends CMS further consider how this proposed NCD would be implemented to ensure patients, providers, pharmacies, and manufacturers have a clear understanding of how best to operationalize the key components of this NCD. Specifically, Gilead recommends that CMS:

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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 offer comments to the Centers for Medicare & Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention. Collectively, our organizations represent people living with HIV; family caregivers; healthcare providers; researchers; coalitions and advocacy organizations focused on chronic disease, aging, and minority and women’s health; private-sector leaders; and clinical trial sites. Together, we strongly support the proposed NCD and urge CMS to finalize it as soon as possible with clarification of benefit classification and affirmative coverage of ancillary services suggested below.

The agency has correctly acknowledged that HIV infection is a national health crisis, and that from 2015 through 2019 the largest percentage increase of persons living with diagnosed HIV infection was among aging adults over 65 years (from 145.5 to 216.0 per 100,000). HIV infection also disproportionately impacts underserved racial and ethnic groups, particularly African Americans and Hispanic Americans. For these reasons, it is of paramount importance that older Americans have access to PrEP treatments.

The FDA has approved three medications for use as PrEP - two oral medications and one injectable. The physician-administered injectable that falls within the Part B benefit required this NCD to ensure beneficiaries have coverage for the treatment. To ensure broad access (and significantly improved outcomes and reduced risk of HIV transmission) to all available treatments, we strongly support that CMS requires Medicare coverage for all forms of PrEP as soon as possible. Patients deserve access to these necessary and innovative treatments.

We also agree with the agency’s conclusions on the three “questions” it posed related to coverage. Most notably, CMS asks, “Is the evidence sufficient to determine that the United States Preventative Services Task Force recommend that clinicians offer PrEP with effective antiretroviral therapy to persons who are at high risk of HIV acquisition with a grade of A or B by the United States Preventive Services Task Force?”. In 2022, the USPSTF released a draft recommendation consistent with the 2019 recommendation giving all PrEP treatments a grade “A” recommendation. Although the USPSTF has not yet finalized its recommendation, we are confident it will and support CMS’s decision that the evidence is sufficient to warrant a grade A recommendation. Further, the evidence cited in the proposed decision is more than sufficient to determine that PrEP using antiretroviral therapy (ART) for persons at high risk of HIV acquisition is reasonable and necessary for the prevention or early detection of illness or disability under §1861(ddd)(1). Third, that same evidence is also amply sufficient to determine that offering PrEP with effective ART for persons at high risk of HIV acquisition is appropriate for Medicare beneficiaries under Part A and Part B. Thus, we support finalizing the draft NCD.

Finally, we note that treatment with PrEP alone is insufficient to care for this at-risk patient population, and for that reason we strongly support the Agency’s proposal to also cover up to seven individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence. We also support the proposal to cover HIV screening up to seven times annually and a single screening for hepatitis B virus (HBV). These additional services are truly reasonable and necessary to this at-risk patient population.

While we support the draft NCD, we believe that the ancillary services CMS proposes to cover in the decision are far too limited, and urge CMS to:

Further, we have noted the reference in the draft NCD to orally-administered PrEP therapies which we understand are not covered under Part B, and we ask that CMS clarify that such self-administered drugs will continue to be covered under Part D. We respectfully suggest that CMS does not have authority in the NCD process to alter the statutory definitions of Part B (physician administered) or Part D (self-administered) drugs, and self-administered oral solid drugs covered in the Part D program are outside the scope of the NCD. Beyond the legal considerations, any shift in the Part D coverage of the oral solids may lead to potential disruptions to distribution and access to drugs that do not require direct administration by a healthcare professional. Further, transitioning orally-administered PrEP therapies to Part B may create additional out-of-pocket costs for beneficiaries – especially in light of the Part D $2,000 out-of-pocket limit that will go into effect in 2025.

Thank you for considering our views and for CMS’ commitment to improved access to PrEP therapy to prevent HIV in at-risk Medicare beneficiaries. If you have questions, please contact Sue Peschin, President and CEO of the Alliance for Aging Research, at speschin@agingresearch.org, or the Alliance's Public Policy Manager, Adina Lasser, at alasser@agingresearch.org.

Sincerely,

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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 health department in the country, with more than 6,000 employees serving eight million diverse New Yorkers. The agency coordinates New York City’s response to the HIV epidemic, including testing initiatives; prevention, care, and treatment programming; epidemiology and surveillance; research and evaluation; training and technical assistance; community engagement; social marketing; policy advocacy; and racial equity and social justice initiatives.

The NYC Health Department applauds CMS’s proposal to cover oral and injectable PrEP to prevent HIV infection in individuals at high risk of acquiring HIV. Oral and injectable PrEP, when taken as prescribed, is safe and highly effective for preventing HIV, and increasing PrEP access and uptake is one of the core strategies in the NYC Health Department’s New York City 2020 Ending the HIV Epidemic Plan.(1) Medicare coverage of PrEP will increase access to this important biomedical prevention intervention and is a critical step toward reducing gender and racial and ethnic inequities in PrEP uptake. While we support CMS’s proposed coverage, we urge CMS to consider the below recommendations.

First, in its proposal, CMS excludes coverage of the number and frequency of STI screenings set forth in the Centers for Disease Control and Prevention (CDC)’s PrEP for the Prevention of HIV Infection in the U.S. – 2021 Update: A Clinical Practice Guideline (PrEP Clinical Practice Guideline).(2) In addition to syphilis, gonorrhea, and chlamydia screening at baseline visits for people taking oral PrEP, the PrEP Clinical Practice Guideline recommends semi-annual screening for syphilis for all sexually active people; quarterly screening for gonorrhea for men who have sex with men (MSM) and transgender women who have sex with men, and semi-annual screening for gonorrhea for heterosexually active people; and quarterly screening for chlamydia for MSM and transgender women who have sex with men, and annual screening for chlamydia for heterosexually active people.(3) For people taking injectable PrEP, the CDC recommends quarterly screening for gonorrhea, chlamydia, and syphilis for MSM and transgender women who have sex with men at every other injection visit starting with the third injection in month three; semi-annual screening for gonorrhea, chlamydia, and syphilis for heterosexually active people starting with the fifth injection in month seven; and annual chlamydia screening in all heterosexually active people.(4) However, despite these CDC recommendations, CMS covers only annual screening for chlamydia and gonorrhea for women at increased risk for STIs and annual screening for syphilis for men and women at increased risk for STIs. This coverage does not correlate with epidemiologic evidence demonstrating that many people taking PrEP are at increased risk for acquiring STIs other than HIV. Given rising rates of STIs across the U.S., the NYC Health Department strongly recommends that CMS extend PrEP coverage to include the STI screenings for people taking PrEP set forth in the CDC’s PrEP Clinical Practice Guidelines.

Second, while CMS proposes coverage of up to seven individual counseling visits for people taking PrEP, the NYC Health Department recommends that CMS extend coverage to include copays for doctor’s visits and lab fees, which can be cost-prohibitive for some patients. These include costs related to STI screening and monitoring of renal function and lipids.

Third, should CMS finalize this proposed decision, the NYC Health Department recommends that CMS widely promote its newly extended coverage of PrEP and related costs. CMS should clearly list all covered visits, screenings, and fees in enrollees’ handbooks and in communications to enrollees, benefits navigators, clinical and supportive service providers, and the general public.

Thank you for the opportunity to comment on this important matter.

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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

VIA ELECTRONIC SUBMISSION

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 professionals, advocates, and people living with, and vulnerable to, HIV. We write regarding the Proposed Decision Memo published on July 12, 2023 for the National Coverage Analysis (NCA) for Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. We strongly support the Centers for Medicare & Medicaid Services (CMS) decision to cover PrEP as a preventive service in Medicare Part B without cost-sharing, including oral and injectable PrEP medication and the requisite ancillary services needed to secure an initial prescription or renewal for PrEP. This coverage decision is a crucial step toward ending the HIV epidemic in the United States.

However, we urge CMS to amend the Proposed Decision in the following ways:

1. Align coverage of PrEP ancillary services with the Centers for Disease Control and Prevention (CDC’s) 2021 HIV PrEP Clinical Practice Guideline.
2. Ensure that the Proposed Decision is written so as to cover at least as many HIV, STI, and renal screenings as are recommended in the CDC Guideline, including:
   1. HIV Antigen/Antibody screenings and RNA screenings; and
   2. Up to four sexually transmitted infection (STI) screenings per year;
3. Remove the term “high risk” to bring the NCD in line with the CDC recommendation that all sexually active adults and adolescents should receive information about PrEP and PrEP should be provided to beneficiaries who request it and for whom it is medically appropriate.

These changes would ensure that:

? All clinical services (counseling and screening) required to prescribe PrEP antiretroviral drugs are clearly understood to be part of the package of covered PrEP services in Medicare Part B; and
? Medicare beneficiaries can access the same lifesaving, comprehensive HIV prevention medications and support services to which private health insurance plan members and many Medicaid beneficiaries are entitled.

Older Adults and other Medicare Beneficiaries Will Benefit from Access to PrEP and Ancillary HIV & STI Testing

We commend CMS for its recognition of the ongoing impact the HIV epidemic continues to have on the United States, including its disproportionate impact on people of color and growing impact on people age 50 and older. HIV disproportionately burdens Black and Latinx communities, with new transmission rates eight and four times higher, respectively, than among the white population in 2019. Almost half of people living with HIV in the U.S. are age 50 and older, and that number is growing as effective treatments have transformed HIV from a terminal illness to a chronic condition when it is well-managed with medication. While many were diagnosed with HIV in their younger years, thousands of older people contract HIV every year. In fact, in 2019, approximately 10% of new HIV diagnoses (3,100) were among people aged 55 and older. Additionally, as of 2019, the CDC estimated that some 18,800 individuals in the United States over age 55 were living with undiagnosed HIV. It is estimated that 40% of new HIV transmissions in the U.S. occur from individuals unaware of their HIV status.¹ Most new HIV diagnoses are attributed to male-to-male sexual contact, placing sexually active gay men age 65 and over at an increased risk for HIV. HIV acquisition is also closely linked to STIs; having an STI makes someone three to five times more likely to acquire HIV.²

The White House Office of National HIV/AIDS Policy highlights the need to expand access to HIV preventive measures such as PrEP in order to end the HIV epidemic in the U.S. in its HIV National Strategic Plan for the United States 2022-2025. The strategy also has a specific focus on older adults, in recognition of the growing population of people living with HIV who are over age 65.³

The U.S. Preventive Services Task Force (USPSTF) has given PrEP a Grade A recommendation because it is safe and effective at preventing the acquisition of HIV. The USPSTF recently issued a draft update incorporating provider-administered PrEP into its PrEP Grade A recommendation.⁴ We are pleased that CMS has proposed to cover both oral and injectable PrEP, including the cost of administration of injectable PrEP and certain ancillary services necessary to access PrEP, without cost sharing. Enabling Medicare beneficiaries to access these services with no out-of-pocket costs will help accomplish our national goal to end the HIV epidemic by 2030.

Medicare Should Also Cover All Screening and Testing Needed for Oral and Injectable PrEP

We appreciate CMS’s recognition that coverage without cost-sharing of the ancillary services required for PrEP is necessary to access this lifesaving preventive care. As CMS acknowledges, PrEP is a “comprehensive intervention comprised of ART and certain support services in order to ensure that PrEP is administered safely and effectively.” We, therefore, urge CMS to make clear in its Decision that CMS will cover all HIV and STI screening and testing recommended under the CDC Clinical Practice Guideline (CDC Guideline)⁵ for the use of PrEP.

The CDC Guideline is cited in the USPSTF’s Grade A recommendation for PrEP and reflects comprehensive guidance for the use of PrEP to prevent the acquisition of HIV among U.S. patients. The CDC Guideline thus sets the standards for what providers who prescribe PrEP must do to ensure that their patients can safely and effectively access HIV prevention. Medicare beneficiaries who would benefit from PrEP should be able to access care that meets these standards.

To that end, we urge CMS to amend the draft Decision to clarify that renal function monitoring will be covered consistent with the CDC Guideline, or at minimum, spell out clearly that renal function testing is already covered by Medicare and should be included as part of the PrEP service package as appropriate.

We also urge CMS to include in its final Decision coverage of "up to four STI screenings annually for people receiving PrEP, as outlined in the 2021 CDC Guidelines." The CDC Guideline reflects that people using PrEP are at a much greater risk of STIs than the general population, with studies indicating that, over the course of a year, nearly half of people on PrEP will be diagnosed with an STI.⁶ Additionally, we urge CMS to ensure that three-site STI testing (pharyngeal, rectal, and urine specimens) will be covered, following the CDC Guideline.

We are pleased that the draft Decision would cover up to seven HIV screening tests per year. However, we urge CMS to be more specific about the kind of HIV test that is covered. CDC's PrEP Guideline requires regular follow-up screening using HIV antigen/antibody testing and RNA testing. We have some concerns that without this specificity, there could be confusion about what type of HIV test is included in Medicare's PrEP benefit.

“Substantial Ongoing” Risk or “Increased” Risk

We recommend the use of the terms “increased risk” rather than “high risk” to describe the population of individuals who would be eligible for coverage of PrEP. Use of the term “increased risk” would better align the NCA with the CDC Guideline, which recommends that clinicians talk to their sexually active adolescent and adult patients about PrEP at least once and prescribe PrEP for those who ask, whether or not justification is provided. The USPSTF’s draft updated recommendation for PrEP also uses the term “increased” rather than “high” risk. Framing patient eligibility for PrEP as those with “increased risk” rather than “high risk” is likely to facilitate PrEP initiation among more people who could benefit from this highly effective HIV prevention method.

Ensuring that Coverage of Oral PrEP Medications in Part B Will Not Create a Barrier to Accessing these Medications at Pharmacies

We strongly support the proposed change that would provide coverage of PrEP in Medicare’s Part B. This move will align PrEP coverage in Medicare with Medicaid and private insurance and remove financial barriers that have posed a barrier to PrEP for Medicare beneficiaries in the past. However, we are conscious that any significant benefit change such as this will come with administrative complexities. We hope that CMS will ensure that this transition will happen as smoothly as possible, to minimize disruption for beneficiaries currently taking daily oral PrEP. We also urge CMS to ensure that Medicare Part D plans, pharmacies, pharmacists, and PrEP providers are well educated about the benefit changes as quickly as possible after it is implemented.

Thank you for reviewing this request and our recommendations. If you would like to discuss this further or have any questions, please contact HHCWAG co-chair, Rachel Klein, Deputy Executive Director, The AIDS Institute, at rklein@taimail.org.

Sincerely,

List of References
1. CDC, HIV Surveillance Supplemental Report at 5-6, 17-19, 31 (vol. 26, no. 1, May 2021), available at www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-26-1.pdf.
2. Wasserheit JN. 1992. Epidemiologic synergy: Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases. Sexually Transmitted Diseases 9: 61-77. Fleming, D. T., & Wasserheit, J. N. 1999. From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sexually transmitted infections, 75(1), 3–17. https://doi.org/10.1136/sti.75.1.3
3. The White House, “National HIV/AIDS Strategy for the United States 2022-2025” ¶¶ 1.2.1, 1.3, 2.5 (2021), available at https://www.whitehouse.gov/wp-content/uploads/2021/11/National-HIV-AIDS-Strategy.pdf.
4. USPSTF, Prevention of Acquisition of HIV: Pre-Exposure Prophylaxis, available at https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/prevention-human-immunodeficiency-virus-hiv-infection-prep
5. US Public Health Service, Preexposure Prophylaxis For the Prevention of HIV Infection in the United States – 2021 Update, A Clinical Practice Guideline, available at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf.
6. Traeger MW, Cornelisse VJ, Asselin J, Price B, Roth NJ, Willcox J, Tee BK, Fairley CK, Chang CC, Armishaw J, Vujovic O, Penn M, Cundill P, Forgan-Smith G, Gall J, Pickett C, Lal L, Mak A, Spelman TD, Nguyen L, Murphy DA, Ryan KE, El-Hayek C, West M, Ruth S, Batrouney C, Lockwood JT, Hoy JF, Hellard ME, Stoové MA, Wright EJ; PrEPX Study Team. Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection. JAMA. 2019 Apr 9;321(14):1380-1390. doi: 10.1001/jama.2019.2947. PMID: 30964528; PMCID: PMC6459111.
Additional study: McManus H, Grulich AE, Amin J, et al. Comparison of Trends in Rates of Sexually Transmitted Infections Before vs After Initiation of HIV Preexposure Prophylaxis Among Men Who Have Sex With Men. JAMA Netw Open. 2020;3(12):e2030806. doi:10.1001/jamanetworkopen.2020.30806

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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 critical role in ensuring patients have immediate access to medications in both community and long-term care (LTC) settings. Together, our members represent a $78.5 billion healthcare marketplace, employ 240,000 individuals, and provide an expanding set of healthcare services to millions of patients every day. Our members are small business owners who are among America’s most accessible healthcare providers.

CMS proposes to cover PrEP using antiretroviral drugs (whether oral or injectable) approved by the US Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of HIV acquisition. The determination of whether an individual is at high risk for HIV infection is made by the physician or health care practitioner who assesses the individual’s history. In addition, CMS proposes to also cover the administration of injectable PrEP using antiretroviral drugs to prevent HIV infection.

CMS also proposes to cover up to seven individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence. Counseling must be furnished by a physician or other health care practitioner and individuals must be competent and alert at the time that counseling is provided. CMS proposes that such coverage is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

NCPA supports state boards of pharmacy and state legislatures granting pharmacists prescriptive authority where it is within pharmacists’ scope of practice to assess whether relevant medications are indicated and appropriate. To that end, at least 11 states give pharmacists authority to initiate HIV PrEP and PEP medications (California, Colorado, Connecticut, Idaho, Illinois, Maine, Nevada, New Mexico, Oregon, Utah, and Virginia). [1] HHS recognized the importance of the community pharmacist to dispense HIV PrEP and PEP medications most recently in its 2022 National HIV/AIDS Strategy for the United States 2022 - 2025. [2]

NCPA has supported state initiatives that give pharmacists authority to initiate HIV PrEP and PEP medications. Since the beginning of this year, pharmacists in Illinois have been able to independently administer HIV PrEP and PEP medications, thanks to the implementation of HB 4430. [3] This legislation was signed into law last year and NCPA joined the Illinois Pharmacists Association in support of this bill. [4] The new law allows pharmacists to dispense and administer drugs, order laboratory tests, and consult patients on HIV PEP/PrEP medications and includes reimbursement for services rendered at no less than 85 percent of the rate if ordered by physicians or other practitioners. In Connecticut, NCPA supported SB 1102,[5] signed into law this year, which permits pharmacists to initiate HIV PEP/PrEP therapies.[6]

If CMS moves forward to cover this benefit under Part B, NCPA asks that CMS formally recognize pharmacists as providers eligible to initiate HIV PrEP services in their scope of practice and to claim reimbursement for the patient assessment, the drugs, and when applicable administering an injectable drug under Medicare Part B.

NCPA is committed to working with CMS and other stakeholders on these important matters. If the agency requires further information or has questions, please contact me at steve.postal@ncpa.org or (703) 600-1178.

Sincerely,
Steve Postal, JD
Director, Policy & Regulatory Affairs
National Community Pharmacists Association

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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 achieve lesbian, gay, bisexual, transgender, and queer (LGBTQ+) equality.  By inspiring and engaging all Americans, HRC strives to end discrimination against LGBTQ+ citizens and realize a nation that achieves fundamental fairness and equality for all.  As an advocate for LGBTQ+ individuals, HRC believes that all people—including LGBTQ+ and other marginalized populations—deserve easy, affordable access to holistic and effective HIV prevention tools.  We therefore applaud CMS for its Proposed Decision Memo, which would provide coverage for PrEP (in both oral and injectable forms, and inclusive of required ancillary services) as a preventive service without cost-sharing through Medicare Parts A and B.  As outlined further below, we urge CMS to quickly work to finalize this guidance with additional language and provisions that would ensure providers are truly empowered to safely and effectively provide PrEP to their patients.

Research on HIV and LGBTQ+ People

While HIV affects Americans from all walks of life, the virus continues to disproportionately impact members of the LGBTQ+ community, including gay, bisexual, and other same-gender-loving men and transgender women.  Communities of color likewise report being disproportionately affected by this ongoing epidemic, leading to outsized and often heartbreaking consequences for LGBTQ+ people of color living at the margins. 

According to the U.S. Centers for Disease Control and Prevention (CDC), there are nearly 1.2 million Americans currently living with HIV with approximately 30,000 people newly diagnosed every year. In 2019 and 2020, men reporting male-to-male sexual contact accounted for over two-thirds of new diagnoses. Additionally, according to a 2015 survey of 28,000 transgender adults, transgender women are living with HIV at over eleven times the rate of the general population. In recent years, there has been a marked and steady increase in new HIV diagnoses among communities of color, particularly in the southern United States. Black people in particular have historically faced the brunt of compounding factors limiting their access to HIV-related care. In 2019 and 2020, Black people accounted for 42% of people newly diagnosed with HIV, with most of those diagnosed being men. The 2015 survey likewise found that one in five Black transgender women are living with HIV.

HIV can impact people across the life course, including older adults receiving their health care coverage through Medicare.  According to CDC data, over half of people living with HIV in the U.S. were aged 50 and older in 2018.  Likewise, approximately 10% of new HIV diagnoses in 2019 were among people aged 55 and older, with an estimated 18,800 individuals over age 55 living with undiagnosed HIV in the U.S. at that time.  According to the Kaiser Family Foundation, more than one quarter (28%) of people living with HIV in the U.S. were estimated to be covered by Medicare in 2020, with the number of Medicare beneficiaries living with HIV more than doubling between then and the 1990s.

Finally, we note that people living with HIV may have other disabilities that qualify them for Medicare benefits prior to the age of 65.  For example, studies have shown that chronic HIV infection and related treatments can at times result in disabling conditions that are otherwise more common among older adults.  Likewise, people with disabilities—particularly women—are at greater risk of experiencing sexual abuse or assault, which could in turn result in HIV infection. 

Research on PrEP 

Considering the continuing impact HIV has on Medicare beneficiaries and older Americans more broadly, we commend CMS for its Proposed Decision Memo and efforts to ensure that these populations can access PrEP.  While tremendous medical advances have helped people living with HIV live longer, healthier lives, there remains no cure and tens of thousands of people are diagnosed every year.  These sobering statistics demonstrate that along with increased access to treatment, all Americans and in particular communities disproportionately impacted by HIV need easy and affordable access to tested and effective HIV prevention education and methods.  Fortunately, the use of PrEP offers a safe and effective way to prevent the transmission of HIV, with the CDC finding that PrEP use “reduces the risk of getting HIV from sex by about 99% when taken as prescribed.” 

Indeed, PrEP is a high-quality intervention that has been rigorously studied and supported by experts for years.  The efficacy of PrEP has long been studied among gay and bisexual men and transgender women with consistent results.  Similarly favorable results have been found in clinical trials involving other impacted populations.  Likewise, peer-reviewed research has examined PrEP from a variety of perspectives, including by researching currently understudied populations impacted by HIV, analyzing varying means of PrEP administration, and examining the factors contributing to groups’ attitudes toward and adherence with PrEP.  We believe that this and other research reviewed by CMS supports its conclusion that PrEP should be covered under Medicare Parts A and B, consistent with the conclusions of the U.S. Preventive Services Task Force (USPSTF) that PrEP, in both oral and injectable forms approved by the U.S. Drug and Food Administration, is an A grade tool for the prevention of HIV.

Despite the known effectiveness of PrEP and recent government efforts to make it more accessible, we know several barriers to accessing that essential intervention persist and which in turn have had a disproportionate impact on populations already experiencing inequities related to HIV.  For example, according to the CDC, only 9% of the nearly 469,000 Black people with indications for PrEP, and 16% of the nearly 313,000 Latinx people indicated for PrEP, received a prescription for it in 2020. In contrast, 66% of White people indicated for PrEP were able to access a prescription.  A 2018 study found that no more than 117,000 people—less than 10% of those at “substantial risk” for HIV per the CDC—were taking PrEP.  While access has been improving, recent CDC data indicate that even in 2020, only 25% of the 1.2 million people in the United States who could benefit from PrEP were prescribed it. 

CMS’s National Coverage Determination Should Be Finalized Inclusive of Provisions Ensuring Beneficiaries’ Full Access to All Necessary PrEP-Related Services

We strongly support CMS finalizing the Proposed Decision Memo to ensure coverage for PrEP, including related and necessary ancillary services, through Medicare Parts A and B.  Below, we outline a few recommendations and considerations for CMS as it does so to ensure that providers will feasibly and sustainably be able to provide PrEP to their indicated patients consistent with our existing knowledge base on barriers to connecting individuals to this essential intervention. 

CMS Should Ensure Comprehensive Coverage for All Recommended Ancillary Services 

First, we recommend that CMS include provisions within the finalized Decision Memo that provide for full coverage of (and detail on) all necessary ancillary services for individuals being prescribed PrEP, consistent with the CDC’s Clinical Practice Guideline.  That guidance outlines the various monitoring and testing services that providers using PrEP with their patients should provide to ensure that those individuals can have PrEP administered “safely and effectively.”

The Draft Decision Memo currently provides that Medicare would cover up to seven HIV screening tests per year, which is consistent with the CDC’s guidance.  However, more information should be provided within the finalized Decision Memo to ensure that these screenings can be properly ordered by providers who may be unfamiliar with HIV and PrEP-related care.  We recommend that the finalized Decision Memo at a minimum provide more specificity on the types of HIV screening (i.e., antigen/antibody testing and RNA testing, as recommended by the CDC) included within the proposed benefit.

Additionally, CMS should take steps so that beneficiaries being prescribed PrEP will be assured access to renal function monitoring, also recommended by the CDC, either by clarifying that such monitoring will also be covered as part of this PrEP-specific benefit, or that it is covered through their existing Medicare coverage and should therefore be provided as part of their PrEP-related care.  Likewise and finally, CMS should include a clear statement of coverage for up to four STI screenings annually for individuals receiving PrEP within the finalized Decision Memo, consistent with the CDC’s guidance and studies referenced within the Draft Decision Memo on the increased risk for STIs faced by people using PrEP when compared to the general population. 

CMS Should Continue Incorporating Coverage for New and Emerging Recommended Methods for Administering PrEP 

We are grateful for CMS’s decision to include both oral and injectable forms of PrEP within the Draft Decision Memo.  We would encourage that the finalized Decision Memo similarly include approval for new and emerging administration methods for PrEP as recommended by the USPSTF that would enable access to same without requiring additional updates to CMS’s National Coverage Determination.

The U.S. Drug and Food Administration (FDA) first approved the oral drug Truvada for PrEP in 2012. As this method of PrEP administration was rolled out to patients, studies began to find that the daily dosing it required was challenging for many individuals.  Investment then began in alternatives that could address such barriers to medication adherence, including in a long-acting injectable form of cabotegravir that has since been approved by the FDA, and was recently included by the USPSTF in an update to its A-grade recommendation for PrEP.

Other forms of PrEP that could continue to bridge the challenges faced by individuals who may have difficulty adhering to oral or even injectable means of taking PrEP are actively being developed.  As we continue to test new modalities, we recommend that CMS’s approval in the finalized Decision Memo be inclusive of these new and emerging administration methods, provided that they receive A or B grade recommendations from the USPSTF in the future.  

CMS Should Broaden the Proposed Scope of Coverage Tied to “Risk” 

We recommend that CMS align its language concerning risk within the Proposed Decision Memo with the CDC’s guidance.  Currently, CMS would call for coverage for PrEP to be limited to “persons at high risk of Human Immunodeficiency Virus (HIV) acquisition,” while both the CDC’s guidance and the USPSTF’s draft updated recommendation for PrEP both instead refer to individuals at “increased” risk for HIV infection.  The CDC currently recommends that clinicians talk to their sexually active adolescent and adult patients about PrEP at least once and prescribe PrEP to those patients that ask for it, regardless of additional justification for it being provided.  CMS should empower physicians wishing to facilitate access to PrEP to a broader range of patients who could benefit from that intervention by adopting this more expansive frame. 

CMS Should Consider Barriers to Providers Being Able to Administer PrEP within the Finalized Decision Memo 

Unfortunately, one barrier to PrEP access has long been the high cost associated with name-brand oral and injectable forms of PrEP.  Over time, pharmacies and providers specializing in PrEP delivery have emerged to help patients access their medication without them or their prescribing providers facing the brunt of these costs and other logistical challenges.  CMS’s National Coverage Determination here would call for PrEP to be administered by individuals’ providers directly, which is likely to raise questions as to the feasibility of doing so by providers with narrow financial margins that CMS should contemplate as it finalizes its Decision Memo.

We anticipate that some providers will call for CMS to also include coverage for PrEP within Medicare Part D as a means of ensuring they can quickly and easily get PrEP into the hands of their patients.  We would recommend that CMS look at other medications that have traditionally been covered under Part D but are also offered as part of individuals’ Part B benefits to see if a model already exists for how these providers could provide PrEP to their patients without incurring significant upfront costs that existing systems may be ill-equipped to reimburse them for in a timely manner.  CMS should likewise think through different challenges that may be faced by smaller health centers and not by hospital-based clinics and other providers with on-site pharmacies.

Conclusion

We are grateful for this opportunity to submit comments in favor of CMS taking such a critical step toward protecting the health and well-being of LGBTQ+ and all other older adults impacted by HIV.  PrEP is a tested, safe, and effective tool for preventing HIV that should be made available to all indicated patients, and through modes of administration that work for them.  To end the HIV epidemic, we must continue working to remove barriers preventing everyone who needs it from being able to access PrEP and applaud the proposed National Coverage Determination and Decision Memo for helping facilitate such access.

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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 include this important benefit in Medicare.

However, I am writing to express my concern about the statement in the draft NCD that limiting screening for sexually transmitted infections (STIs) to annual screening and/or screening for those with signs and symptoms of infection is sufficient.

Prescribing PrEP without Frequent STI Screening is Counterproductive
As stated in the draft NCD, bacterial STIs increase the risk of HIV acquisition. Recent studies have also shown that some populations on PrEP have high STI incidence. Prescribing PrEP while not screening for, diagnosing, and treatment bacterial STIs could potentially increase HIV risk, which runs counter to the purpose of prescribing PrEP.

Frequent STI Screening for Men Who Have Sex with Men and Trans Women is Rated A or B by USPSTF
As stated by other commenters, though CMS states that “in the future, we may consider screening for additional populations if recommended with a Grade A or B by the USPSTF,” it is important to recognize that USPSTF already does encompass quarterly chlamydia and gonorrhea screenings for men who have sex with men and transgender women within its A-rating for PrEP. The 2021 STI screening recommendations are superseded for all PrEP patients by the STI screening recommendations in the USPSTF PrEP recommendation (which will be updated later this year).

Covering PrEP Without Covering Frequent STI Screening Will Deepen Disparities
In the draft NCD, CMS states that the outcome of STI screening will not affect a clinician’s decision on whether to prescribe PrEP. While that may be true from a clinical standpoint, it is not true from a coverage standpoint. Any clinician prescribing PrEP will want and need to order quarterly STI screening consistent with CDC guidelines and the clinical standard of care, creating a gap between Medicare covered services and services rendered, which will result in uncompensated care. While health care facilities and Medicare beneficiaries with abundant financial resources may be able to absorb the costs of this uncompensated care, those health care facilities and Medicare beneficiaries with limited resources will not be able to absorb these costs, deepening racial and health disparities. Failure to consider these real-world implications in CMS deliberations when developing the final PrEP NCD would be out of alignment with President Biden’s Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.

Waiting to Screen for STIs Based on Signs and Symptoms Risks STI Complications
The rate of bacterial STIs have increased significantly in recent years, both nationally and in California, with artificial dips in 2020 and 2021 due to gaps in routine screening of asymptomatic infections during the COVID-19 pandemic. On December 23, 2020, the California Department of Public Health (CDPH) issued a Dear Colleague Letter alerting health care providers of increasing reports of Disseminated Gonococcal Infection (DGI) cases in California during the second half of 2020. As of February 2022, CDPH had recorded roughly double the number of DGI cases in 2020 compared to 2019, and DGI cases in 2021 exceeded the total number of cases in 2020 – including four deaths last year that were likely attributable to DGI. Most DGI cases in California have occurred among adults aged 30-50 years old (which is an age group not typically screened for gonorrhea but that may overlap with the Medicare population) and disproportionately among Hispanic/Latinx individuals. In addition, approximately a fifth of cases have reported experiencing homelessness, more than a third report using one or more illicit drugs, and a third of total cases report using methamphetamine specifically. Of note, the majority of DGI cases to date did not present with urogenital symptoms.

For these reasons, I urge CMS to reconsider its exclusion of frequent STI screening in its draft HIV PrEP National Coverage Determination for Medicare to better align the NCD with current CDC guidelines.

Thank you for your consideration.

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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 at risk.

We are in strong support of the National Coverage Determination (NCD) to cover all forms of PrEP under Medicare. As the second-largest federal source of financing for HIV care, it is critical that Medicare covers these life-saving prevention services. Many in our community who would benefit from PrEP are unable to access care due to a range of barriers such as cost of the medication, associated lab work and factors such as housing instability and lack of provider knowledge. Having as many options available to clients as possible, including injectable PrEP which would be covered under this proposal, is essential.

An important element of full coverage under Medicare is the impact on seniors. Most recipients of Medicare qualify due to age, while the CDC estimates that over half of people diagnosed with HIV are age 50 and older. Older Americans have not traditionally been prioritized for HIV prevention and screening. Moreover, LGBTQIA+ seniors face systemic barriers compared to their non-LGBTQIA+ peers that leave them vulnerable to poorer health outcomes, social isolation and stigma. Coverage of PrEP under Medicare will erase one of those barriers and aid in the fight to stop the spread of HIV among older adults.

We support the inclusion of up to seven counseling and screening visits per annum under the NCD. According to the CDC, one in eight people living with HIV are unaware that have the virus, and roughly 75% of people at greater risk for HIV do not receive yearly testing. Moreover, roughly 40% of new HIV infections are transmitted by people who are undiagnosed. Rapid screening, diagnosis and immediate referral into treatment are imperative to reduce new infections. Coverage of counseling visits and screening will help turn the tide against these grim statistics.

Finally, we urge CMS to include full laboratory costs as part of coverage under Medicare. Laboratory costs can be significant for some and serve as a real barrier for individuals who are seeking access to care. With only 25% of individuals in target groups that would benefit most from PrEP currently taking the medications, any avenue that would increase access is important.

As a frontline provider, we stress the importance of PrEP as an essential part of the fight to stop the spread of HIV/AIDS. We urge CMS to provide full coverage of PrEP, including injectable PrEP, and all ancillary services such as laboratory costs and screening under Medicare.

Thank you for your consideration of our comments.

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**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 Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (Proposed Decision Memo CAG-00464N)

Dear Dr. Chin,

The American Clinical Laboratory Association (ACLA) is pleased to submit our written comments on the Proposed Decision Memo and Proposed National Coverage Determination (NCD) for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (CAG-00464N), hereafter referred to as the proposed NCD. ACLA is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

ACLA applauds the Centers for Medicare & Medicaid Services (CMS) for recognizing the benefit of offering PrEP with effective antiretroviral therapy (ART) to Medicare beneficiaries at high risk of acquiring HIV. As noted by the Centers for Disease Control and Prevention (CDC) in its 2021 Clinical Practice Update for Preexposure Prophylaxis for the Prevention of HIV Infection in the United States, the overall estimated annual HIV incidence rate remained stable from 2014 through 2018 [1]. However, according to 2018 data, higher percentages of newly diagnosed HIV infections were found for men having sexual activity with men and for Hispanic/Latino and African American heterosexuals. The CDC 2021 Update notes that “[e]quitable provision of PrEP to populations at highest risk of HIV acquisition is not occurring.”

We agree with the CDC that improved access to HIV prevention methods, such as PrEP, are vital to help address these disparities. While we believe that this proposed NCD is poised to greatly increase access to PrEP for Medicare beneficiaries, there are many limitations included in the policy that will prevent Medicare beneficiaries from receiving the same standard-of-care treatment as individuals who are not Medicare beneficiaries.

ACLA’s concerns detailed below cover the disparities in care and financial burden between Medicare beneficiaries on PrEP and non-Medicare beneficiaries, the lack of clarity for Creatinine clearance-related maintenance testing for Medicare beneficiaries on certain types of PrEP, lack of coverage for CLIA-validated, non-FDA-approved or -cleared tests, and additional coding considerations.

A. Disparities in Care and Financial Burden between Medicare Beneficiaries on PrEP and Non-Medicare Beneficiaries on PrEP

The current CDC recommendations for PrEP use in men who have sex with men (MSM), heterosexual women and men, and persons who inject drugs include follow-up visits at least every 3 months to provide the following [2] : HIV testing, medication adherence counseling, behavioral risk reduction support, side effect assessment, STI (sexually transmitted infection) symptom assessment, and STI testing for high-risk groups.

Based on the current CDC recommendations, the standard of care provided for patients administered oral PrEP includes the following tests performed 4 times a year:

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 pivotal step towards reducing HIV transmission and improving public health outcomes, while also addressing one of the top barriers to implementation: the absence of reimbursement.

The Foundation is an independent nonprofit organization dedicated to advancing health, wellness, and optimal medication usage through research and education. Our core values are centered on a patient-centric approach, which strives to elevate individual health and wellbeing while promoting rational medication therapy, accessible healthcare, research, and education. Given our focus on accessible healthcare, we aim to increase patient access to pharmacist delivered PrEP and PEP care and services. We were co-sponsors of California Senate Bill (SB) 159 a bill which became law, effective January 2020, that permits pharmacists to initiate PrEP and PEP without a prescription from another healthcare provider.

Additionally, the Foundation sponsored research with California HIV/AIDS Policy Research Centers in collaboration with the Center on Reproductive Health, Law to investigate pharmacists’ understanding and barriers to the delivery of HIV preventive care and other sexual and reproductive health services in California (1). Notably, 96% of respondents felt delivery of these services was important but then cited the lack of insurance coverage as a barrier to implementation. Hence, we strongly encourage inclusion of the word "pharmacist" in the text, making it clear that they can be reimbursed for their services.

To conclude, we encourage the addition of “pharmacist” to the proposed Appendix B language. By addressing a significant barrier to implementation, the lack of reimbursement, we stand to strengthen collective efforts to combat HIV transmission and ultimately enhance the health and well-being of our communities. If you have any further questions or would like additional information, please contact us at 916-447-1033 or via email at cshpoffice@cshp.org.

(1) https://www.chprc.org/news/california-pharmacists-willing-to-prescribe-hiv-prevention-and-contraception-but-few-do/

APPENDIX B
Medicare National Coverage Determinations Manual

Draft

We are seeking public comments on the proposed language that we would include in the Medicare National Coverage Determinations Manual. This proposed language does not reflect public comments that will be received on the proposed decision memorandum, and which may be revised in response to those comments.

Table of Contents
(Rev.)
NCD 210.15 – Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention

A. General
Human immunodeficiency virus (HIV) continues to be a serious public health issue, with an estimated 1.2 million people aged 13 and older living with HIV in the United States. Due to continuing medical advances and earlier initiation and expanded access to medications, HIV is now considered a chronic condition rather than a terminal illness. Antiretroviral therapy (ART) is known to reduce HIV-related morbidity and mortality. Nearly half of the people in the United States diagnosed with HIV are aged 50 and older. Pre-exposure prophylaxis (PrEP) involves the use of ART on an ongoing basis (e.g., daily or bimonthly) or before and after HIV exposure events (“on-demand” or “event-driven” PrEP) to decrease the risk of acquiring HIV infection. When taken as prescribed, PrEP is highly effective for preventing HIV. PrEP can be an oral medication or an injection. Under §1861(ddd)(1) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of “additional preventive services” through the Medicare national coverage determination (NCD) process if certain statutory requirements are met: (1) reasonable and necessary for the prevention or early detection of illness or disability, (2) recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF), and (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

B. Nationally Covered Indications
Effective for claims with dates of service on or after xx/xx/xx, CMS proposes that the evidence is adequate to conclude that the United States Preventive Services Task Force (USPSTF) recommends offering Pre-Exposure Prophylaxis (PrEP) with effective antiretroviral therapy (ART) to persons at high risk of Human Immunodeficiency Virus (HIV) acquisition with a grade of A recommendation, is reasonable and necessary for the prevention or early detection of illness or disability under §1861(ddd)(1) of the Social Security Act (the Act), and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.
CMS proposes to cover PrEP using antiretroviral drugs (whether oral or injectable) approved by the US Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of HIV acquisition. The determination of whether an individual is at high risk for HIV infection is made by the physician, pharmacist, or health care practitioner who assesses the individual’s history. In addition, CMS proposes to also cover the administration of injectable PrEP using antiretroviral drugs to prevent HIV infection.

CMS also proposes to cover up to seven individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence. Counseling must be furnished by a physician, pharmacist, or other health care practitioner and individuals must be competent and alert at the time that counseling is provided.

Additionally, for individuals being assessed for or who are taking PrEP using ART to prevent HIV infection, CMS proposes to cover HIV screening up to seven times annually and a single screening for hepatitis B virus (HBV). These screening tests are proposed to be covered with the appropriate FDA approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations.

C. Nationally Non-Covered Indications
Preventive services are non-covered by Medicare unless specifically covered in this NCD, any other NCD or in statute or regulations.

D. Other
Medicare Part B coinsurance and deductible are waived for this preventive

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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 support CMS's decision to provide Pre-Exposure Prophylaxis (PrEP) with effective antiretroviral therapy (ART) to individuals at heightened risk of HIV acquisition. Furthermore, we advocate for the inclusion of STD and hepatitis screenings as integral components of PrEP care. We request CMS to update the National Coverage Determinations Manual, ensuring consistent PrEP coverage across both private insurers and Medicare Parts A & B. It's essential for CMS to encompass a comprehensive follow-up care plan for PrEP users, extending beyond HIV tests and adherence and mental health counseling. We further emphasize the adoption of regular STI screenings and renal function evaluations, as detailed in the Centers for Disease Control and Prevention’s (CDC) Preexposure Prophylaxis Exposure for the Prevention of HIV Infection in the United States – 2021 UPDATE. Without clear stipulations for such evidence-driven follow-up care, there's a risk of creating coverage disparities based on an individual's insurance type.

Expanded Comments for Consideration

1. NCD Coverage for All PrEP Drugs: Consistent with how National Coverage Determinations (NCDs) traditionally operate, we advocate that the NCD should encompass all new PrEP drugs, covering the entire class. This broader approach aligns with established practices and ensures that beneficiaries have uninterrupted access to a range of preventive options.

2. Oral PrEP, Injectables & Innovation: As the field of HIV prevention evolves with oral and injectable PrEP options, we believe it is essential to allow flexibility in drug administration classification. Restricting these drugs under Medicare Part B could inadvertently limit beneficiaries' access to emerging and innovative solutions. The evolving landscape of HIV prevention, particularly with the potential of injectable PrEP, calls for a more flexible approach in drug administration classification. A rigid transition to Part B might limit the options available to beneficiaries, as innovation in this field continues at a rapid pace.

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 Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention (CAG-00464N).

CVS Health serves millions of people through our local presence, digital channels, and our nearly 300,000 dedicated colleagues – including more than 40,000 physicians, pharmacists, nurses, and nurse practitioners. Our unique health care model gives us an unparalleled perspective on how systems can be better designed to help consumers navigate the health care system – and their personal health care – by improving access, lowering costs, and being a trusted partner for every meaningful moment of health. And we do it all with heart, each and every day.

The Centers for Medicare & Medicaid Services (CMS) proposes to cover PrEP using antiretroviral drugs (whether oral or injectable) approved by the US Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of HIV acquisition based on the assessment of the individual’s history by a physician or health care practitioner. CMS also proposes to cover up to seven individual counseling visits every 12 months and HIV screening up to seven times annually and a single screening for hepatitis B virus (HBV). CMS states that that these services will be categorized as "additional preventive services" for which Medicare Part B coinsurance and deductibles will be waived.
CVS Health supports the coverage of PrEP antiretroviral drugs and the related preventive services under Medicare, and we are committed to working with the federal government and other stakeholders to improve access to PrEP and end the HIV epidemic. CVS Health participates in HHS Ready Set PrEP Program and is a member of The US Business Action to End HIV which one of its focuses is increasing PrEP coverage.

Based on our review of the NCD, it is not clear what the impact of this new coverage under Medicare Part B would have on the coverage of antiretroviral drugs under Part D. Currently, antiretroviral drugs for the treatment of HIV are covered under Medicare Part D as protected class drugs to which utilization management edits such as prior authorizations (PAs), step therapy may not be applied. We ask that CMS clarify whether these drugs would continue to be covered under Part D in the same way as they are today if the NCD is finalized as proposed, or whether Part D coverage would be limited or changed in some way.

Specifically, we ask that CMS clarify:

1. How, if at all, the coverage will differ for high-risk individuals and those that are not high risk?
2. If the drugs remain covered under Part D for certain individuals (e.g., those not at high risk) or for treatment purposes rather than prevention, will CMS expect and/or permit Part D plans to implement PAs for purposes of determining Part B vs. Part D coverage? Without these types of PAs, Part D plans will not have sufficient information to determine coverage, and so to adjudicate a claim for a PrEP drug correctly.
3. Will health care providers be responsible for notifying a pharmacy and plan if the individual no longer qualifies for coverage under Part B so that the pharmacy can change the billing to Part D? Or would Medicare Advantage organizations (MAOs) be required to periodically confirm that the criteria for coverage under Part B are still met? If so, would this verification be required to be performed annually?

We ask that CMS confirm that MA plans will be permitted to implement step therapy requirements for antiretroviral drugs in accordance with 42 CFR 422.136. This would be an important cost containment measure because of the significant price difference between different antiretroviral drug therapies.

We also ask that CMS confirm if the NCD does not meet the significant cost threshold of 42 CFR 422.109(a), the effective date of the new coverage requirements for the PrEP antiretroviral drugs and related preventive services change for MAOs will not be earlier than the first plan year after the NCD is finalized for which MAO plans have an opportunity to build the additional costs into their bids. So, for example, if the NCD is finalized in September 2023, it will not be effective for MAOs until the plan year beginning on or after January 1, 2025, since the bids for the 2024 plan year have already been submitted. This will ensure that MAOs are not required to assume risk for the costs of these new preventive services until the contract year for which payments are appropriately adjusted to take into account the additional costs. In addition, we ask that this same time frame apply for Part D sponsors so that they can make the necessary operational changes and communications to pharmacies regarding any changes in Part D coverage for the PrEP antiretroviral drugs because of the finalization of the NCD.

Lastly, as CMS finalizes this NCD and determines how best to meet the needs of the community in need of PrEP, we ask that CMS consider leveraging pharmacists who are on the front lines and directly interact with patients all across the country each and every day. Pharmacists have the education, ability, and accessibility to play an elevated role in patient health. All 50 states now have recognized pharmacists’ clinical ability and enhanced their scope of practice in one or more areas. With the launch of EHR capabilities to pharmacies, pharmacists are now positioned as integrated members of the patient healthcare team. However, barriers to pharmacist delivered services still exist limiting ability to operationalize care more broadly including lack of provider recognition to enable Medicare beneficiary coverage of pharmacist-based services as well as inconsistent and limited state allowances. We are happy to work with CMS to breakdown those barriers.

Thank you for considering our comments. We would be happy to respond to any follow-up questions you may have.

Sincerely,

Melissa Schulman
Senior Vice President, Government & Public Affairs
CVS Health

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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 (CMS) Proposed National Coverage Determination (NCD) for Preexposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention, published on July 12, 2023. AHIP is the national association whose members provide health care coverage, services, and solutions to hundreds of millions of Americans every day. We are committed to making health care better and coverage more affordable and accessible for everyone. Thank you for the opportunity to provide comments and feedback.

Every American deserves access to affordable coverage that provides them with resources to prevent, diagnose, and manage acute and chronic health conditions, including HIV – a disease that affects 1.2 million Americans. HIV disproportionately impacts the LGTBQIA+ community and other populations that already face greater health disparities, especially Black, Hispanic, Native American and other underserved people. Health insurance providers share CMS’ commitment to improving health equity and accessible care for all Americans and work every day to promote the health and wellness of people who may be at risk of HIV.

CMS proposes coverage under Medicare Part B of PrEP using antiretroviral drugs (whether oral or injectable) approved by the U.S. Food and Drug Administration (FDA) to prevent HIV in individuals at high risk of HIV acquisition as “additional preventive services” under §1861(ddd)(1) of the Social Security Act. CMS also proposes coverage of the administration of injectable PrEP using antiretroviral drugs to prevent HIV. CMS proposes to cover up to seven individual counseling visits, every 12 months, including HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence. CMS proposes to cover HIV screening up to seven times annually and a single screening for hepatitis B virus (HBV), for individuals being assessed for or who are taking PrEP using antiretroviral therapy to prevent HIV.

We support CMS’ proposal to increase access to HIV PrEP for Medicare enrollees.

For Americans who are at risk of contracting HIV, PrEP medications and related services are highly effective and essential to disease prevention. Health insurance providers cover recommended, evidence-based preventive care – including PrEP – to improve health outcomes. PrEP is effective in preventing HIV and can reduce the incidence of HIV. Nearly 40,000 Americans acquire HIV every year, and if used as directed, PrEP can reduce the risk of HIV transmission by about 99%. Additionally, health insurance providers strongly support the inclusion of counseling for risk assessment, risk reduction, and medication adherence in the proposed NCD to help ensure that patients are fully informed.

We ask CMS to consider the following operational issues related to the Proposed NCD:

1. We encourage CMS to align the NCD with PrEP recommendations and clinical considerations published by the U.S. Preventive Services Task Force (USPSTF), including those related to follow-up visits, adherence counseling, and HIV and other screenings. USPSTF is comprised of an independent group of experts in preventive medicine and adheres to parameters of public engagement when making its recommendations. CMS’ NCD should align with the significant work that has been done by the Task Force on PrEP to ensure consistent recommendations and messaging. USPSTF is in the process of updating its recommendation on PrEP for HIV, with publication of a final recommendation expected in the coming months.

2. CMS should coordinate with the Centers for Disease Control and Prevention (CDC), the Office of National AIDS Policy (ONAP), the USPSTF, the Agency for Healthcare Research and Quality (AHRQ), and the FDA to ensure that messaging and guidance for patients and providers is consistent across government entities. The evidence supports the use of PrEP as a highly effective tool to prevent HIV, but the medications must be used as directed. Coordinated and consistent guidance will help support provider and consumer education and promote shared decision-making on the use of PrEP for HIV. For example, CMS notes that there are numerous screening and assessment tools, but further information for providers would help them identify the appropriate populations who should receive PrEP, including cultural awareness training to address stigma, evaluate social risk factors, and communicate with their patients in an empathetic way regarding their level of HIV risk.

Patients could benefit from coordinated resources and messaging to help them better understand their care options and what PrEP treatment entails. Patients should be informed, for example, that PrEP does not protect against other sexually transmitted infections. And with more options available for PrEP, patients should understand their medication options and work with their doctors to choose the product with which they will most likely have success.

3. If CMS finalizes the NCD allowing for Medicare coverage of PrEP for HIV prevention under Part B, we request that CMS’ Office of the Actuary provide, as quickly as possible after the final NCD is released, a determination of whether the NCD would meet the requirements of section 1852(a)(5) of the Social Security Act for plan year 2023 and 2024, as it pertains to Medicare Advantage (MA) plans. Under that statutory provision, if CMS determines that an NCD would result in a significant change in costs, Original Medicare is required to assume the costs covered by the NCD for MA enrollees until the plan year for which the expected costs are appropriately reflected in MA benchmarks.

In addition, PrEP medications can currently be covered under Part D. The NCD proposes to cover oral and injectable PrEP for HIV and associated services for individuals at high risk of HIV acquisition exclusively under Part B. However, antiretroviral medications may be used for purposes other than the conditions under the proposed NCD, such as used in combination with other therapies to treat HIV. As a result, the same medications may be covered under Part B or Part D depending upon the circumstances. Further, antiretroviral drugs are a protected class of drugs under Part D. Accordingly, if the NCD is finalized, we request that CMS issue additional guidance clarifying the expectations and flexibilities available to plans for determining appropriate coverage for the drugs under the two benefits.

Thank you for focusing on this important public health issue. We share your commitment to preventing HIV transmission in the United States. We welcome the opportunity to work with you to protect Americans from this disease that affects millions of Americans from all walks of life. We look forward to working with your offices to ensure Americans have equitable access to PrEP and related services.

For questions, please email kberry@ahip.org.

Sincerely,

Kate Berry
Senior Vice President, Clinical Innovation and Strategic Partnerships

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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 the lives of the nearly two million transgender people in the United States and their families through sound public policy, public education, and groundbreaking research. NCTE has worked with countless health and human service providers as well as local, state, and federal agencies on policies to ensure equal access to vital health and human services. In 2015, NCTE conducted the U.S. Transgender Survey (“USTS”), the largest survey to date of transgender people, with nearly 28,000 respondents from all 50 states and the U.S. territories.

The USTS reiterated what we have long known: disproportionately high rates of transgender people are living with HIV. According to the 2015 USTS, the rate of respondents who were living with HIV (1.4%) was more than four times as high as that in the U.S. general population (0.3%). Rates were significantly higher for transgender women (3.4%), Black respondents (6.7%), American Indian respondents (2.0%) and Latine respondents (1.6%), with rates especially high for transgender women of color. Nearly one in five (19.0%) Black transgender women reported living with HIV, a rate that is more than thirteen times higher than that in the overall sample. American Indian (4.6%) and Latina (4.4%) transgender women also reported substantially higher rates of HIV.

When broken out by age cohorts, the rate of people living with HIV was highest among respondents aged 45-64 (3.3% reported living with HIV). Because the 2015 USTS data was collected eight years ago, many of this demographic have already become Medicare-eligible, with many more aging into Medicare eligibility in the coming years. As the generation that lived through the 1980s AIDS epidemic ages into eligibility (a person who was 20 in 1981, when the CDC published its first report on what would come to be identified as AIDS, will turn 65 in 2026), coverage for PrEP will become all the more critical.

Comments on the Proposed Determination
We strongly support the national coverage determination of the HIV prevention modality, PrEP. As CMS notes, PrEP is a modality of biomedical and biopsychosocial interventions.

Organizational Sustainability Requires Coverage for Services and Medication
We recommend CMS NCD approve PrEP’s attendant services without cost sharing under Medicare Parts A & B and require coverage of PrEP medications under Medicare’s Part D drug coverage without beneficiary cost sharing.

Community health center operations and non-profit health providers generally operate with narrow financial margins. Due to the high cost of name-brand oral and injectable PrEP, they must have coverage and assurance of reimbursement to provide this treatment and medications. For example, Apretude’s retail price is nearly $4,000 per injection. The ability to secure this and oral medications through Medicare Part D prescription drug plans is critical for cash flow and smooth operations. When the medications are covered under Part B, the health center must buy the medications and then submit a claim including the medication and wait for reimbursement. For FQHCs who are paid through the Prospective Payment System (PPS, a predetermined fixed amount based on previous year’s cost report), this fixed rate payment means that FQHCs have no option to include the high cost medication for reimbursement through Part B and it would be financially devastating and not feasible. Ensuring medication – even injectables – are covered through Medicare Part D is critical to the ability for health centers to provide these services and remain financially viable. Without coverage in Part D, the cost of drug acquisition would be devasting to health center operations and impede efforts to scale PrEP uptake in underserved communities.

Enumerate All Covered Services for PrEP Modality
We concur with CMS that the evidence prepared for the USPSTF recommendation on PrEP with ART demonstrates efficacy and safety for persons who are at high risk of HIV. As well, we recommend for CMS NCD screening eligibility criteria guidelines to align their language concerning ‘high risk’ determination to CDC’s guidelines indicating “PrEP use for sexually-active persons,” instead of restricting the criteria solely to ‘high risk individuals.’ The small harms that exist are mitigated through ongoing risk assessment counseling and monitoring for safety; including HIV screening and STI screening for chlamydia, gonorrhea, and syphilis, kidney function and lipid testing. CMS’ determination includes seven HIV screens, one HBV screen, and seven individual counseling visits every 12 months. We strongly recommend that CMS include in the final NCD up to four STI panel screenings, which should cover quarterly chlamydia, gonorrhea, and syphilis screens; annual kidney function assessments, measured by creatine ratio; pregnancy tests, and annual urine glucose and urine protein assessments, per year. There should also be specificity added to the HIV screening recommendations to allow for viral load screening and assessment. Including these screenings and assessments would bring CMS’ coverage into alignment with the CDC’s recommendations and USPSTF recommendations. We also support the inclusion of an exception for coverage of additional PrEP-related screenings and counseling services when deemed medical necessary by an enrollee’s provider.

CMS identifies that the laboratory screenings and ongoing monitoring are covered for beneficiaries and may be ordered at the discretion of the health care provider. We recommend that CMS explicitly name in the text of the NCD the recommended and covered laboratory screenings and ongoing monitoring assessments identified above. It is our experience that many practitioners benefit from the additional information on the standard of care for people at high risk of HIV acquisition.

Currently, community pharmacies can improve patient adherence and retention in treatment plans through increasing the availability of the medication, supporting the inclusion of clinical staff and community health workers and pharmacy staff in patient care, and ensuring the efficient operation of health centers through the contributions of pharmacy income to health center sustainability.

Evergreening the NCD
There are many PrEP with ART products in the development pipeline. While we understand that CMS’ NCD for Medicare parts A and B requires a Grade A or B by the USPSTF, we know that new modalities for HIV prevention are required to end the HIV epidemic, in particular to reach populations of women at high risk for HIV acquisition. As we continue to test new modalities, we recommend that CMS’ approval be inclusive of new and emerging administration methods that receive grade A or B recommendations from the USPSTF in the future.

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 support the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for preexposure prophylaxis (PrEP) for HIV Prevention for Medicare beneficiaries. IDSA/HIVMA is a community of more than 12,000 physicians, scientists and other health care and public health professionals who specialize in infectious diseases. Within IDSA, HIVMA represents nearly 5,000 physicians, scientists, and other health care professionals around the country on the front lines of the HIV epidemic.

As noted in the NCD, PrEP is a highly effective biomedical intervention that prevents HIV transmission when taken as prescribed. PrEP was approved by the Food and Drug Administration eleven years ago, and now multiple types of medications, oral and injectable, are available, including generics.

The August 2022 HIV Surveillance supplemental report estimated that 1.2 million people in the U.S. were eligible for PrEP, but only 25% were prescribed PrEP in 2020, resulting in a 75% gap in access to this effective HIV prevention medication. CDC’s National HIV Surveillance System also reported that during the first half of 2022, just 30% of males and 9% of females eligible for PrEP were prescribed PrEP. Among persons 55 years or older who could benefit, just 25% were prescribed PrEP. To help address these disparities, an important step is for all federal programs to provide consistent and comprehensive coverage of all formulations of PrEP.

With this in mind, we offer the recommendations below to bring Medicare’s NCD in line with the standard of care for PrEP according to the 2021 CDC PrEP Guidelines as recognized in the USPSTF Grade A Recommendation for PrEP and in guidance issued by the CMS Center for Insurance and Information Oversight.

Screening for Sexually Transmitted Infections

In the NCD, it is noted that Medicare’s recommendation for coverage of STI screenings is based on the USPSTF for Chlamydia and Gonorrhea screening that is not based on the populations who could benefit from PrEP or the standard of care set by the CDC that is referenced in the USPSTF PrEP recommendation. The CDC recommendations are informed by data indicating that PrEP use has been associated with increased incidence of STIs . We strongly recommend that the NCD for Medicare beneficiaries be consistent with what is recommended for people on PrEP to identify and treat STIs early to prevent illness and onward transmission. Specifically, we recommend that the NCD recommend that STI screenings be covered for up to 4 times a year and specify that multiple anatomic site testing (i.e., genital, oropharyngeal, and rectal) is recommended for gonorrhea and chlamydia.

Screening for Hepatitis C

In addition to a single screening for hepatitis B virus (HBV), the NCD should cover hepatitis C (HCV) screening at initiation followed by a minimum of annual HCV screening given that routine HCV screening is recommended for people with “continued risk ”, which include people who inject drugs and men who have sex with men. If HCV screening is already covered at the discretion of the provider, we recommend noting this in the coverage determination to confirm that Medicare recognizes HCV screening as part of PrEP.

Monitoring Renal Functioning & Pregnancy

We appreciate that Medicare covers laboratory tests for renal functioning and pregnancy ordered at the discretion of the health care provider. We recommend noting within the coverage determination that these tests are already covered at the discretion of the provider so that it is clear that Medicare covers these screenings as recommended in the CDC PrEP Guidelines.

Covering HIV RNA Test for Long-Acting PrEP

We recommend adding coverage of HIV RNA testing for patients who are initiating long-acting injectable PrEP. The HIV RNA test is a nucleic acid test that detects the virus in the blood earlier than antibody or antigen tests. Earlier detection is important before starting long-acting injectable PrEP to reduce the risk of resistance to HIV antiretrovirals given the long-acting nature of injectable PrEP. Coverage of an HIV RNA test will bring Medicare’s NCD in line with the CDC’s PrEP Guidelines.

Following the CDC Indications for PrEP

We recommend that Medicare follow the standard set by the CDC in specifying that all sexually active adult and adolescent Medicare beneficiaries should receive information about PrEP and that PrEP should be provided to any patient who requests it and for whom it is medically appropriate. This is important to not restrict PrEP access for beneficiaries who may not consider themselves high risk and to ensure that access and coverage of PrEP is not dependent on provider judgment particularly given that some providers may not recognize the vulnerability of their Medicare patients to HIV. It also is important to avoid the use of terms such as “high risk” to reduce the stigma and discrimination that has contributed to the limited use of PrEP by the hundreds of thousands of people in the U.S. who could benefit from it but are not currently on it.

Transitioning from Medicare Part D to Part B

We understand that with this NCD that PrEP coverage will be transitioning from Medicare Part D to Part B to remove the financial barriers to PrEP experienced by beneficiaries. We support this change but recommend that there be a transition period for beneficiaries currently accessing PrEP under Medicare Part D, an educational campaign for providers, pharmacies and pharmacists and that steps be taken to mitigate any additional administrative requirements for providers.

Thank you for considering this request to strengthen Medicare’s proposal to cover FDA-approved PrEP medications. Ensuring comprehensive coverage of PrEP across all federal programs, including Medicare, is critical to promote equitable access to this highly effective prevention intervention. If there are any questions regarding our recommendations to bring the NCD in line with the current PrEP standard of care, please contact Andrea Weddle, HIVMA’s executive director at aweddle@hivma.org.

“PrEP for HIV Prevention in the U.S.” Centers for Disease Control and Prevention, November 23, 2021. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html#:~:text=Notable%20gains%20have%20been%20made,only%20about%203%25%20in%202015.
Centers for Disease Control and Prevention. Core indicators for monitoring the Ending the HIV Epidemic initiative (preliminary data): National HIV Surveillance System data reported through September 2022; and preexposure prophylaxis (PrEP) data reported through June 2022. HIV Surveillance Data Tables 2022;3(4). https://www.cdc.gov/hiv/library/reports/surveillance-data-tables/. Published December 2022. Accessed August 2023
Preexposure Prophylaxis For The Prevention Of HIV Infection In The United States – 2021 UPDATE. (n.d.). https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-provider-supplement-2021.pdf
US Preventive Services Taskforce. (2022, December 13). Prevention of acquisition of HIV: Pre-exposure prophylaxis. https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/prevention-human-immunodeficiency-virus-hiv-infection-prep
FAQs Part 47 - Centers for Medicare & Medicaid Services. (n.d.-a). https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-47.pdf
US Preventive Services Taskforce. (2021, September 14). Chlamydia and gonorrhea: Screening. Recommendation: Chlamydia and Gonorrhea: Screening | United States Preventive Services Taskforce. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/chlamydia-and-gonorrhea-screening
Traeger, M. W. (2019, April 9). Association of HIV Preexposure prophylaxis with incidence of STIs. JAMA. https://jamanetwork.com/journals/jama/fullarticle/2730113
Jansen, K., Steffen, G., Potthoff, A., Schuppe, A.-K., Beer, D., Jessen, H., Scholten, S., Spornraft-Ragaller, P., Bremer, V., & Tiemann, C. (2020, February 7). STI in times of prep: High prevalence of chlamydia, gonorrhea, and Mycoplasma at different anatomic sites in men who have sex with men in Germany - BMC infectious diseases. BioMed Central. https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-020-4831-4
US Preventive Services Taskforce. (2020, March 2). Hepatitis C virus infection in adolescents and adults: Screening. Recommendation: Hepatitis C Virus Infection in Adolescents and Adults: Screening | United States Preventive Services Taskforce. https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c-screening
Centers for Disease Control and Prevention. (2022, June 22). Types of HIV tests. Centers for Disease Control and Prevention. https://www.cdc.gov/hiv/basics/hiv-testing/test-types.html
Eshleman, S. H., Fogel, J. M., Halvas, E. K., Piwowar-Manning, E., Marzinke, M. A., Kofron, R., Wang, Z., Mellors, J., McCauley, M., Rinehart, A. R., St Clair, M., Adeyeye, A., Hinojosa, J. C., Cabello, R., Middelkoop, K., Hanscom, B., Cohen, M. S., Grinsztejn, B., Landovitz, R. J., … Clark, R. (2022). HIV RNA screening reduces integrase strand transfer inhibitor resistance risk in persons receiving long-acting cabotegravir for HIV prevention. The Journal of Infectious Diseases, 226(12), 2170–2180. https://doi.org/10.1093/infdis/jiac415

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

Quest Diagnostics is the world’s leading provider of diagnostic information services with a vision to empower better health with diagnostic insights. The work we do has a profound impact on patients. Diagnostic testing accounts for only 2-3 percent of healthcare spending but drives 70 percent of healthcare decisions. Quest serves one in three adult Americans and about half of physicians and hospitals in the United States annually. We have over 7,300 patient access points, including phlebotomists in physician offices and 2,100 patient service centers. Quest is passionate about providing patients with accurate, timely, and affordable, insights into their health.

Quest Diagnostics applauds CMS for recognizing the benefit for offering PrEP with effective antiretroviral therapy (ART) to Medicare beneficiaries at high risk of HIV acquisition and agrees with the comments submitted by the American Clinical Laboratory Association (ACLA).

In particular, we wish to reinforce ACLA’s comments related to potential disparities in care and financial burden between Medicare beneficiaries on PrEP and non-Medicare beneficiaries on PrEP. It is important to ensure that Medicare beneficiaries, especially those most at risk, receive access to HIV prevention methods such as PrEP. Given the higher risk for other STIs among PrEP patients, it is equally important that beneficiaries receive related testing services when they access PrEP treatment. A 2021 memo regarding the implementation of the Affordable Care Act released by the Departments of Labor, Health and Human Services (HHS), and Treasury recommended that private payers cover the CDC-recommended testing regimen for PrEP with no cost-sharing to patients. The proposed NCD specifically addresses HIV and Hepatitis B testing. We believe it is important for the NCD to acknowledge that it does not preclude CDC recommend diagnostic testing for high-risk individuals to help ensure that Medicare beneficiaries receive the same standard-of-care treatments as non-Medicare beneficiaries.

Moreover, the proposed NCD only mentions coverage of seven instances of HIV screens and one HBV screen annually. If coverage of the other CDC recommended testing is the intention of CMS, CMS should clarify. Otherwise, this policy may inadvertently result in ordering providers either cutting back on the recommended testing for Medicare patients on PrEP or proceeding with ordering only the NCD recommended testing, forgoing additional CDC recommended tests, which would negatively impact beneficiaries.

We strongly encourage CMS to cover all CDC recommended testing and amend the NCD language to ensure that it is clear that Medicare beneficiaries should receive the same standard-of-care treatment and benefits recommended for all patients while taking PrEP. Evidence suggests individuals on PrEP may be at higher risk of STIs than those not on PrEP and limits on STI testing may further exacerbate these disparities.

It is the upmost priority that we eliminate disparities in care for Medicare beneficiaries to ensure they are provided quality care and critical testing services. We would welcome the opportunity to work with you on the proposed NCD. Thank you for your consideration and please do not hesitate to contact me if you have any questions or would like additional information.

Robert Jones, DO, FIDSA
Medical Director Infectious Diseases
Quest Diagnostics

1. FAQS ABOUT AFFORDABLE CARE ACT IMPLEMENTATION PART 47 July 19, 2021, accessible here: https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf

2. The CDC guidelines on PrEP for the prevention of HIV infection are available at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf - recommendations taken from Table 1a: Summary of Clinician Guidance for Daily Oral PrEP Use and Table 5: Timing of Oral PrEP-associated Laboratory Tests

3. Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection | Infectious Diseases | JAMA | JAMA Network and STI in times of PrEP | BMC Infectious Diseases (biomedcentral.com)

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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 the nation, I write to provide comments on the proposed decision memo regarding Medicare coverage of Pre-Exposure Prophylaxis (PrEP) for HIV infection prevention.

Primary care physicians play a vital role in reducing HIV transmission by screening patients and identifying those at high-risk for Human Immunodeficiency Virus (HIV) infection. Expanding coverage to HIV pre-exposure prophylaxis will bolster family physician efforts to prevent and reduce HIV transmission. The AAFP supports the proposal from the Centers for Medicare and Medicaid Services (CMS) to cover under Medicare Part B:

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 New York City HIV Planning Group (HPG)/HIV Health and Human Services Planning Council of New York (Planning Council)’s Joint Policy Committee and our community partners, we thank you for the opportunity to comment on the recently released draft decision memorandum for the National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS) on pre-exposure prophylaxis (PrEP) using antiretroviral therapy to prevent HIV infection.

We fully support the CMS proposal to cover PrEP using antiretroviral drugs (whether oral or injectable) approved by the US Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of HIV acquisition, to be determined by healthcare professionals. This proposal would also cover the administration of injectable PrEP, up to seven counseling sessions a year that includes HIV risk reduction, and up to seven HIV screenings annually.

Promoting greater access to PrEP is a crucial strategy to prevent HIV infection and reduce the impact of the HIV epidemic. PrEP is a highly effective HIV prevention method for individuals at risk of acquiring HIV. At the same time, PrEP can be costly, making it inaccessible for some individuals. Governments and healthcare systems should work to ensure that PrEP is affordable and covered by insurance plans to make it accessible to those who need it.

In 2019 in the New York Eligible Metropolitan Area (NY EMA) alone, which includes New York City, Westchester, Rockland and Putnam Counties, there were 1,910 new diagnoses of HIV infection. Every new diagnosis of HIV is an opportunity lost, and we are committed to taking greater steps to reduce new infections. Expanding access to PrEP is key in efforts to end the HIV epidemic in the United States. Making sure that Medicare beneficiaries can benefit from the expanding spectrum of PrEP options without cost sharing, including availability through Part A and B, is an important step in expanding access.

We also ask that CMS consider enhancing its coverage determination proposal for PrEP by extending coverage to include copays for doctor’s visits and lab fees associated with PrEP, which can result in fiscal barriers for some patients. In addition, CMS guidelines should prohibit prior authorization and other utilization management tools used by payors for the purpose of determining risk of HIV infection; this decision should be made by the clinician and the patient. We also recommend that coverage be expanded to include routine testing (three site testing; genital, oral, and anal with self-administered swabs) for other sexually transmitted diseases for all individuals who receive PrEP treatment. Ideally, testing for STIs should at least be equal to the same frequency of testing for HIV that this coverage determination proposes.

Finally, we also respectfully ask CMS to refrain from identifying coverage as appropriate specifically for “high risk” individuals; this phrase can be stigmatizing and may result in some providers inappropriately labeling patients as not “high risk” and missing opportunities to expand PrEP access. Also, the use of stigmatizing language, and labelling patients or their behaviors as "high risk," may discourage patients from seeking PrEP and other health-related services. We urge CMS to follow the CDC’s most recent PrEP guidelines, which recommend that PrEP be discussed with all sexually active adults and adolescents, and that PrEP be prescribed to all who request it. Without an explicit endorsement of CDC PrEP guidelines, providers and payors may unnecessarily limit access to PrEP to the many patients who are uncomfortable nor adept at detailing their HIV risk or who may be inappropriately evaluated as not “high” risk.

By implementing these steps, communities and the United States can work towards making PrEP more accessible and effective in preventing new HIV infections, ultimately contributing to the reduction of HIV transmission rates and improving public health outcomes.

We thank you for the opportunity to comment on the proposed national coverage determination for PrEP to prevent new HIV infections. Should you have any questions, please feel free to contact JPC co-chairs, Matthew Lesieur at matthew@ihealthnys.org or Luis Nava at lnava@latinoaids.org.

Thank you.

Sincerely,

Luis Nava, Co-Chair
HPG/Planning Council Joint Policy Committee
lnava@latinoaids.org

Matthew Lesieur, Co-Chair
HPG/Planning Council Joint Policy Committee
matthew@ihealthnys.org

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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. With fifty-six locations across Southeast Texas, Legacy is on the front lines of providing comprehensive HIV care to some of the nation’s most vulnerable populations in Texas. Legacy also has a robust HIV testing program that prioritizes the region’s most vulnerable populations and thereby has the highest positivity rates in Texas.

We strongly support the national coverage determination of the HIV prevention modality, PrEP. As CMS notes, PrEP is a modality of biomedical and biopsychosocial interventions.

We recommend CMS NCD approve PrEP’s attendant services without cost sharing under Medicare Parts A & B and require coverage of PrEP medications under Medicare’s Part D drug coverage without beneficiary cost sharing.

Community health center operations and non-profit health providers generally operate with narrow financial margins. Due to the high cost of name-brand oral and injectable PrEP, they must have coverage and assurance of reimbursement to provide this treatment and medications. For example, Apretude’s retail price is nearly $4,000 per injection. The ability to secure this and oral medications through Medicare Part D prescription drug plans is critical for cash flow and smooth operations. When the medications are covered under Part B, the health center must buy the medications and then submit a claim including the medication and wait for reimbursement. For FQHCs who are paid through the Prospective Payment System (PPS, a predetermined fixed amount based on previous year’s cost report), this fixed rate payment means that FQHCs have no option to include the high-cost medication for reimbursement through Part B and it would be financially devastating and not feasible. Ensuring medication – even injectables – are covered through Medicare Part D is critical to the ability for health centers to provide these services and remain financially viable. Without coverage in Part D, the cost of drug acquisition would be devasting to health center operations and impede efforts to scale PrEP uptake in underserved communities.

We strongly recommend that CMS include in the final NCD up to four STI panel screenings, which should cover quarterly chlamydia, gonorrhea, and syphilis screens; annual kidney function assessments, measured by creatine ratio; pregnancy tests, and annual urine glucose and urine protein assessments, per year. There should also be specificity added to the HIV screening recommendations to allow for viral load screening and assessment.

We recommend that CMS explicitly name in the text of the NCD the recommended and covered laboratory screenings and ongoing monitoring assessments identified above.

As we continue to test new modalities, we recommend that CMS’ approval be inclusive of new and emerging administration methods that receive grade A or B recommendations from the USPSTF in the future.

Thank you for the opportunity to submit comments on behalf of Legacy Community Health. If I can be of further assistance to you, please do not hesitate to reach out to us at LLanagan@LegacyCommunityHealth.org.

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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, M.D., Lead Medical Officer

Dear Director Syrek Jensen and Deputy Director Chin:

ViiV Healthcare Company (ViiV) applauds the Centers for Medicare & Medicaid Services (CMS) for its Proposed Decision Memo on the National Coverage Analysis (NCA) for Pre-Exposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. We agree with the conclusion that evidence is adequate to state that PrEP is reasonable and necessary for the prevention or early detection of illness or disability under §1861(ddd)(1) of the Social Security Act (the Act), and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. Within this Proposed Decision Memo, CMS has recommended to cover FDA-approved PrEP options (whether oral or injectable), HIV and hepatitis B testing associated with PrEP, administration of injectable PrEP, and counseling visits associated with PrEP initiation and continued use. We are pleased to see the specific mention of long-acting injectable PrEP, an innovative PrEP method that has the potential to benefit individuals who are not willing or able to utilize daily oral PrEP. Expanding PrEP options available may help end the HIV epidemic and address health disparities in HIV diagnoses and PrEP use which currently persist. This NCD is an important step forward in terms of promoting health equity in the U.S. given the health disparities found in the HIV epidemic. We wish to offer some suggestions on how the final NCD might solidify access to PrEP for those who may benefit from it and combat stigma related to HIV.

About ViiV: ViiV is the only independent, global specialist company devoted exclusively to delivering advancements in human immunodeficiency virus (HIV) treatment and prevention to support the needs of people with HIV and those vulnerable to HIV. From its inception in 2009, ViiV has had a singular focus to improve the health and quality of life of people affected by this disease and has worked to address significant gaps and unmet needs in HIV care. In collaboration with the HIV community, ViiV remains committed to developing meaningful treatment advances, improving access to its HIV medicines, and supporting the HIV community to facilitate enhanced care and treatment.

I. Medicare Plays a Critical Role in Ending the HIV Epidemic and Promoting Health Equity
ViiV applauds CMS for its quick action in opening an NCA and subsequent review for the NCD for PrEP for Medicare populations to access HIV prevention. As the CMS Coverage Analysis Group (CAG) has acknowledged, Medicare is an important source of coverage for people vulnerable to HIV acquisition. This NCD is acutely important to populations potentially impacted by HIV as they rely heavily on the Medicare program for their health care needs. Of note, the number of Medicare beneficiaries with HIV has more than doubled since the 1990s, and Medicare is the second largest source of federal financing for HIV care and treatment.(1) PrEP is a critical tool in ending the HIV epidemic in the U.S. including among the Medicare beneficiary population. The 2022-2025 National HIV/AIDS Strategy (NHAS) outlined a goal of reaching 50 percent PrEP coverage by 2025 from a baseline of 13.2 percent in 2017 and the CDC’s PrEP Clinical Practice Guidelines support rapidly expanding PrEP delivery to all who may benefit.(2,3) A final PrEP Medicare NCD will position CMS as a leader and assist in reaching these goals.

ViiV supports the work of the Department of Health and Human Services (DHHS) and CMS to promote health equity and to reduce racial and ethnic health disparities.(4,5,6) Addressing HIV incidence rates must be considered an important part of CMS’s efforts to address health disparities. Of the approximately 1.2 million people who could benefit from PrEP in the United States, only 25 percent have received a prescription.(7) Despite the availability of daily oral PrEP for over a decade,(8) its effectiveness can be limited by inconsistent adherence as well as structural and societal barriers that lead to underutilization in key populations, perpetuating health disparities. For example, 42 percent of new U.S. HIV diagnoses in 2020 occurred among Black individuals, and 27 percent occurred among Hispanic/Latinx individuals.(9) Given the severity of racial disparities of HIV, we applaud CMS efforts on this NCD as it supports its goal to address racial and ethnic health disparities and racial disparities within the HIV epidemic in the U.S.

ViiV applauds CMS for including the following in the Proposed Decision Memo:

We thank CMS for acknowledging there are currently multiple dosage formulations of FDA approved PrEP that should be covered with this proposed decision memo, leaving no ambiguity that coverage should extend to the FDA approved injectable option Apretude (cabotegravir long-acting [CAB-LA]) for PrEP. We thank the CAG for thorough review of pivotal PrEP clinical trials, including the HIV Prevention Trials Network (HPTN) 083 and HPTN 084 studies which demonstrated long-acting injectable cabotegravir was associated with statistically significant decreased risk of HIV acquisition versus oral TDF-FTC in cisgender men who have sex with men (MSM) and transgender women who have sex with men and cisgender women at high risk of HIV infection. Please see table below on additional suggested language regarding this topic.

We appreciate CMS recognizing the importance of coverage of the administration of a health care provider administered injectable PrEP. Coverage of the medication itself is only one part of complete PrEP care. Allowing for coverage of administration of the a long-acting option lifts the burden of cost-sharing off Medicare beneficiaries who would otherwise have multiple ancillary services to pay for when receiving PrEP.

3. HIV Testing for PrEP Use

We applaud CMS for providing a recommendation to cover HIV testing with the appropriate FDA approved laboratory tests and point of care tests, consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations for Medicare beneficiaries using PrEP. Regular HIV testing is recommended as part of ongoing PrEP use and furthermore, we support HIV testing consistent with FDA approved labeling such as the specific tests noted in the US prescribing information for Apretude. Coverage of the medication itself is only one part of complete PrEP care. Allowing for coverage of HIV testing lifts the burden of cost-sharing off Medicare beneficiaries who would otherwise have multiple ancillary services to pay for when receiving PrEP and allows PrEP providers to deliver high quality care in line with CDC guidelines and US prescribing information. Please see table below on additional suggested language regarding this topic.

We praise CMS for recognizing the importance of a comprehensive HIV prevention program which includes counseling and medication adherence support. As CMS discusses throughout the Proposed Decision Memo, adherence to PrEP is highly associated with its efficacy in preventing the acquisition of HIV. Coverage of the medication itself is only one part of complete PrEP care. Allowing for coverage of HIV counseling lifts the burden of cost-sharing off Medicare beneficiaries who would otherwise have multiple ancillary services to pay for when receiving PrEP and allows PrEP providers to deliver high quality care in line with CDC guidelines and US prescribing information. Please see table below on additional suggested language regarding this topic.

We thank CMS for acknowledging that HIV disproportionately impacts historically underserved groups that bear the most severe burden of HIV across the country. With this acknowledgement, CMS brings important awareness to the impacts that social, economic, and demographic factors, such as stigma, discrimination, income, education, and geographic location may have on a persons’ likelihood of acquiring HIV. Further, we appreciate CMS highlighting an important excerpt from each FDA-approved PrEP option’s US prescribing information: “risk for HIV acquisition includes behavioral, biological, or epidemiologic factors including but not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV status, or sexual activity in a high prevalence area or network”.

Raising awareness that Undetectable=Untransmittable, or U=U, is critical to every message of HIV prevention. We thank you for remembering this important component to ending the HIV epidemic when discussing HIV prevention options.

We appreciate that CMS reviewed multitudes of data yet focused on those currently FDA approved with the exception of review of the Bangkok Tenofovir Study. We appreciate the limited data available in this population and believe this is an important study to review and include.

We support the review and discussion of evidence-based guidelines such as the CDC and IAS-USA to underpin coverage decisions. Clinical care should first and foremost be evidence-based, and we appreciate the thorough review of this expert-led guidance.

Acknowledgment in the NCD that the decision of whether to start PrEP remains in the hands of the health care provider and the person who may benefit from PrEP is key to optimal care without unnecessary barriers. Further, we appreciate inclusion of quotes from the WHO discussing the characteristics and behaviors of not only an individual but also of their partner(s) that may lead to HIV exposure. Here, CMS raises awareness that even in localities of low HIV incidence, there may be people who may benefit from PrEP services and that those individuals requesting PrEP should be offered it, when medically appropriate.

We urge CMS to consider the following suggestions and comments on the Proposed Decision Memo:

IV. Importance of HIV Screening

Current FDA approved oral and injectable PrEP formulations require HIV negative status be confirmed prior to and during use of PrEP.(10,11,12) If HIV infection occurs while someone is on PrEP (oral or injectable), there is a risk of HIV resistance substitutions developing. The CAB-LA US prescribing information requires HIV testing at initiation and with each subsequent injection using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV; and, if an antigen/antibody test is used, a negative result must be confirmed with an RNA assay. The CDC PrEP guidelines also recommend confirmation of antigen/antibody test results using qualitative or quantitative RNA assays for persons with recent exposure to or use of antiretroviral prophylaxis.(13) Of the HIV tests currently available, the RNA assay can detect the presence of HIV the earliest, followed by the antigen/antibody tests.(14) The combination of these tests allows for the use of three different markers to identify and confirm if someone is living with HIV. If an HIV infection is confirmed, it is important to transition someone rapidly to a fully active HIV treatment regimen not only for their own health, but also because the likelihood of HIV transmission from persons with acute HIV is very high.

To support health care practitioners with billing of PrEP antiretrovirals, CMS should allow pharmacists and other health care practitioners to bill for long-acting injectable PrEP and related services under Medicare Part B and Part D. Specifically, CMS should grant pharmacists and other health care practitioners with prescribing and/or administering rights under their respective state laws with the ability to bill Medicare Part B for long-acting injectable PrEP and/or its administration.

Current payer coverage of long-acting injectable PrEP is available through medical benefit, pharmacy benefit, or sometimes both. If accessed via medical benefit, providers of long-acting injectable PrEP may use either a buy-and-bill model or utilize an assignment of benefits model through specialty pharmacy. Under the buy-and-bill model, providers purchase long-acting injectable PrEP and submit claims to payers for reimbursement of the product and administration services on their own. These providers have invested in the administrative capabilities to purchase and track inventory, as well as to establish claims submission procedures to receive payment for the product and related services under the medical benefit. Many providers do not have the ability to invest in the administrative, technological, and other resources necessary to properly buy-and-bill under Part B.

Another option is to utilize the pharmacy benefit route. Under the pharmacy benefit, providers order long-acting injectable PrEP from pharmacies that subsequently process the order as a prescription for delivery to the provider’s clinic or other alternate site of administration (also known as “white bagging”). In this scenario, the pharmacy will seek reimbursement from plans under the pharmacy benefit and from beneficiaries for any applicable cost-sharing liability. If the NCD is finalized as proposed, the health care provider ultimately administering long-acting injectable PrEP will be able to seek reimbursement for product administration services. CMS should ensure that pharmacists and all health care providers who have prescribing and/or medication administering rights within a state are able to bill Medicare Part B for such services. These providers will not be able to submit claims for both the product and administration services of long-acting injectable PrEP unless CMS grants them the authority to do so.

CMS should support all PrEP providers receiving appropriate payment under the Part B or Part D benefit to ensure the broadest access to PrEP antiretrovirals. As such, CMS should allow pharmacists to bill Medicare Part B for PrEP antiretrovirals and/or their administration in alignment with state laws. Pharmacists play a critical role in administering PrEP antiretrovirals and granting them authority to bill Part B for PrEP antiretrovirals and/or their administration will facilitate beneficiary access in this vital setting of care. Though the NCD does not apply to Part D plans, CMS should urge these plans to cover PrEP antiretrovirals in accordance with the final NCD, including providing zero cost-sharing for all FDA-approved PrEP options and ancillary services such as HIV screening, counseling, and long-acting injectable PrEP administration.

ViiV recommends CMS provide Medicare Administrative Contractors (MACs) guidance as soon as possible on the appropriate billing and coding to support implementation of the final NCD. MACs will likely need sufficient time to establish their claims processing systems in accordance with the final NCD. Appropriate guidance to MACs will facilitate beneficiary access to FDA-approved PrEP antiretrovirals on the effective date of the NCD. ViiV recommends CMS include the following product, counseling, diagnosis, and testing codes in the guidance to MACs to properly effectuate the final NCD. Note: this list is not all-inclusive.

CMS should also consider adding G0475 (HIV antigen/antibody, combination assay, screening) that is used to implement NCD 210.7 (Screening for the Human Immunodeficiency Virus (HIV) Infection) to the list of appropriate HIV screening codes for use under the final PrEP NCD.

Thank you for your consideration of these comments. The ongoing efforts to end the HIV epidemic in the U.S. represent a unique and timely opportunity where scientific data, innovation, and public health resources have come together. We applaud CMS in issuing positive coverage requirements regarding access not only to the FDA-approved PrEP antiretrovirals, but also to the ancillary services such as testing, administration, and counseling within Medicare to support these efforts, and its efforts to promote health equity.

Sincerely,

Michael Aboud, MD
VP, ViiV North America Medical Affairs
ViiV Medical Affairs
michael.x.aboud@viivhealthcare.com

1. Kaiser Family Foundation. Medicare and People with HIV. March 27, 2023. https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/. Accessed August 06, 2023.
2. The White House. 2021. National HIV/AIDS Strategy for the United States 2022–2025. Washington, DC. Accessible at: https://files.hiv.gov/s3fs-public/NHAS-2022-2025.pdf.
3. Centers for Disease Control and Prevention. U.S. Public Health Service. Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 Update: a clinical practice guideline. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed August 06, 2023.
4. Department of Health and Human Services. HHS Action Plan to Reduce Racial and Ethnic Health Disparities: A Nation Free of Disparities in Health and Health Care. Accessible at: https://www.minorityhealth.hhs.gov/assets/pdf/hhs/HHS_Plan_complete.pdf. Accessed August 07, 2023.
5. CMS Framework for Health Equity 2022-2032. Accessible at: https://www.cms.gov/files/document/cms-framework-health-equity.pdf. Accessed August 07, 2023.
6. CMS.gov. CMS Strategic Plan. May 16, 2023. Accessible at: https://www.cms.gov/cms-strategic-plan. Accessed August 07, 2023.
7. CDC Fact Sheets: PrEP for HIV Prevention in the US. November 23, 2021. https://www.cdc.gov/nchhstp/newsroom/fact-sheets/hiv/PrEP-for-hiv-prevention-in-the-US-factsheet.html. Accessed February 06, 2023.
8. CDC Newsroom: CDC Statement on FDA Approval of Drug for HIV Prevention. July 16, 2012. https://www.cdc.gov/nchhstp/newsroom/2012/FDA-ApprovesDrugStatement.html. Accessed February 06, 2023.
9. Centers for Disease Control and Prevention. HIV Surveillance Report, 2020; vol. 33. May 2022. Accessible at: https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2020-updated-vol-33.pdf. Accessed August 07, 2023.

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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 health, and scientists with expertise in the management of HIV and STI.

The NNPTC supports and applauds the Centers for Medicare and Medicaid Services’s (CMS) proposal to cover Pre-Exposure Prophylaxis (PrEP) using oral and injectable antiretroviral drugs approved by the US Food and Drug Administration to prevent HIV infection in individuals at high risk of HIV acquisition. The NNPTC further supports CMS’s proposal to cover up to 7 individual counseling visits, every 12 months, that include HIV risk assessment, HIV risk reduction and medication adherence, coverage of HIV screening up to 7 times every 12 months, and a single screening for Hepatitis B.¹

While this proposal is an important step in improving access to PrEP for all persons who would benefit and protecting them against HIV, reducing HIV-related health disparities and moving the U.S. toward its goal of ending the HIV epidemic, an essential part of PrEP care is missing—it excludes coverage for STI screening as a part of routine PrEP visits.

HIV and other STI including syphilis, gonorrhea, and chlamydia represent a syndemic. Any proposal to address one must also address the other. Without coverage for STI screening, the proposal is incomplete, missing the opportunity to benefit the health and wellbeing of persons receiving PrEP and neglecting a critical opportunity to address the current STI crisis in the U.S. The NNPTC asks that you consider coverage for STI screening as a part of routine PrEP visits.

This request aligns with the coverage for pre-exposure prophylaxis as outlined in FAQS about Affordable Care Act Implementation Part 4, prepared jointly by the Departments of Labor, Health and Human Services (HHS), and the Treasury, published July 19, 2021.² Question 1 of the FAQ states: “Are plans and issuers required to provide coverage without cost sharing for items or services that the USPSTF recommends should be received by a participant, beneficiary, or enrollee prior to being prescribed anti-retroviral medication as part of the determination of whether such medication is appropriate for the individual and for ongoing follow-up and monitoring?”³

The response as it relates to STI states, “Persons taking PrEP must be screened for STIs at baseline and should be screened periodically thereafter consistent with CDC guidelines, which may require multiple anatomic site testing (i.e., genital, oropharyngeal, and rectal) for gonorrhea and chlamydia, and testing for syphilis, together with behavioral counseling, which are recommended to reduce the risk of STIs, the presence of which may increase the likelihood of acquiring HIV sexually.”³

According to the CDC Sexually Transmitted Diseases Surveillance Program, the U.S. has seen a surge of STI over the last 10 years. In 2021, alone, more than 2.5 million cases of chlamydia, gonorrhea, and syphilis were reported.⁴ As we see modest declines in new HIV infection with PrEP and other interventions, we have seen a concomitant rise in STI.^5-7 Comprehensive PrEP care must include STI screening and treatment as currently recommended by the CDC.⁸ Notably, persons who use PrEP, especially gay, bisexual, and other men who have sex with men (GBM) face considerably high rates of STI, regardless of PrEP use.^9-11 Black and Latino GBM have the highest burden of new HIV and STI, yet remain with lower PrEP uptake; these sexual networks will be the most impacted.¹² Cisgender women account for nearly 1 in 5 new HIV diagnoses in the US yet have considerably lower PrEP uptake. As we face the renewed public health crisis of rising congenital syphilis cases, PrEP care without routine STI screening will miss a critical opportunity to identify and reduce these cases along with other bacterial STIs that cause substantial reproductive morbidity. Providing PrEP care without comprehensive STI care will worsen the discordance in the HIV and STI epidemics, delay care, and exacerbate the already severe disparities in STI among GBM, cisgender women, and racial and ethnic minority persons.^13,14

We are grateful for this opportunity to make this public comment and urge you to include coverage for STI screening as a part of routine PrEP care. The request aligns with scientific evidence, the recommendations of the CDC and other U.S. leaders in PrEP, HIV, and STI care. Finally, it aligns with guidance provided for PrEP as a part of coverage of preventive services and as a part of the Affordable Care Act.³

Thank you for your consideration.

Nicholas Van Wagoner, MD, PhD, FACP (he/him)<,br> Associate Professor of Medicine
Associate Dean for Students
University of Alabama Heersink School of Medicine
NNPTC Co-Chair
Southeast Prevention Training Center

Ronnie M. Gravett, MD, MSPH
Assistant Profession of Medicine
University of Alabama Heersink School of Medicine
Southeast Prevention Training Center

Jeanne Marrazzo, MD, MPH, FACP, FIDSA (she/her/hers)
Director, Division of Infectious Diseases
C. Glenn Cobbs, M.D., Endowed Chair in Infectious Diseases
Executive Vice Chair, Department of Medicine
University of Alabama at Birmingham School of Medicine

References

1. CMS. Preexposure Prophylaxis (PrEP) Using Antiretroviral Therapy to Prevent Human Immunodeficiency Virus (HIV) Infection. Web site. Published 2023. Updated Accessed August 8, 2023, 2023.
2. Government. DotUS. FAQS ABOUT AFFORDABLE CARE ACT
IMPLEMENTATION PART 47. Web site. Published 2021. Updated Accessed August 8, 2023, 2023. 3. Martin ET, Krantz E, Gottlieb SL, et al. A pooled analysis of the effect of condoms in preventing HSV-2 acquisition. Arch Intern Med. Jul 13 2009;169(13):1233-1240.
4. CDC. Sexually Transmitted Disease Surveillance 2021. Web site. Published 2023. Updated Accessed August 8, 2023, 2023.
5. Mayer KH, Venkatesh KK. Interactions of HIV, Other Sexually Transmitted Diseases, and Genital Tract Inflammation Facilitating Local Pathogen Transmission and Acquisition. American Journal of Reproductive Immunology. 2011;65(3):308-316.
6. Johnson LF, Lewis DA. The effect of genital tract infections on HIV-1 shedding in the genital tract: a systematic review and meta-analysis. Sex Transm Dis. Nov 2008;35(11):946-959.
7. Pathela P, Braunstein SL, Blank S, Schillinger JA. HIV Incidence Among Men With and Those Without Sexually Transmitted Rectal Infections: Estimates From Matching Against an HIV Case Registry. Clinical Infectious Diseases. 2013;57(8):1203-1209.
8. Centers for Disease Control and Prevention: US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2021 Update – A Clinical Practice Guideline December 2021 2021.
9. Chapin-Bardales J, Johnson Jones ML, Kirkcaldy RD, et al. Pre-exposure Prophylaxis Use and Detected Sexually Transmitted Infections Among Men Who Have Sex With Men in the United States-National HIV Behavioral Surveillance, 5 US Cities, 2017. J Acquir Immune Defic Syndr. Dec 1 2020;85(4):430-435.
10. Gravett RM, Westfall AO, Overton ET, Kudroff K, Muzny CA, Eaton EF. Sexually transmitted infections and sexual behaviors of men who have sex with men in an American Deep South PrEP clinic. Int J STD AIDS. Feb 2020;31(2):127-135.
11. Clement ME, Nicchitta M, Sun Y, et al. Preexposure Prophylaxis Outcomes in an Urban Community in North Carolina: Discontinuation of Care and Sexually Transmitted Infections. Sexually Transmitted Diseases. 2021;48(3):183-188.
12. Whitfield THF, Parsons JT, Rendina HJ. Rates of Pre-exposure Prophylaxis Use and Discontinuation Among a Large U.S. National Sample of Sexual Minority Men and Adolescents. Arch Sex Behav. Jan 2020;49(1):103-112.
13. Ramchandani MS, Golden MR. Confronting Rising STIs in the Era of PrEP and Treatment as Prevention. Current HIV/AIDS Reports. June 01 2019;16(3):244-256.
14. Jongen VW, Zimmermann HML, Goedhart M, et al. Can we screen less frequently for STI among PrEP users? Assessing the effect of biannual STI screening on timing of diagnosis and transmission risk in the AMPrEP Study. Sexually Transmitted Infections. 2023;99(3):149-155.

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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. Li:

On behalf of the HIV+Hepatitis Policy Institute, an organization dedicated to promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions, we thank you for issuing the recently released draft decision memorandum for the National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS) on pre-exposure prophylaxis (PrEP) using antiretroviral therapy to prevent HIV infection.

Before we offer our specific comments on the draft NCD, we want to thank you for acting so quickly on this proposal and for your genuine interest in expanding Medicare coverage of all forms of PrEP as a no-cost preventive service. This will help improve PrEP access and uptake and bolster efforts to end the HIV epidemic in the United States. The first provider-administered medication for HIV pre-exposure prophylaxis (Apretude or cabotegravir as PrEP) was approved by the Food and Drug Administration in January 2022. In August 2022, we wrote to you on behalf of 64 organizations to request that CMS quickly and efficiently evaluate provider-administered PrEP for a National Coverage Determination. (1) In February 2023 we submitted public comments on the NCD during the initial public comment period (2).

While we commend CMS on the draft NCD memorandum specific to provider-administered PrEP, we urge CMS to amend it in a number of areas, as described below. Additionally, we do have a number of implementation concerns pertaining to oral PrEP that CMS must address. These are also described below.

With deep and widening racial, ethnic, and gender disparities in uptake, access to PrEP through Medicare is of paramount importance to making sure that Medicare beneficiaries are able to benefit from the widening array of PrEP options without cost-sharing. Medicare beneficiaries (including those dually eligible for Medicaid) comprise 10 percent of the population using PrEP (3), including both individuals over 65 as well as disabled individuals under 65. We thank CMS for making clear that all FDA-approved forms of PrEP would be available without cost-sharing. This means that Medicare beneficiaries will have unfettered access to future novel forms of PrEP immediately after FDA approval.

Please find below our specific comments, suggestions, and areas of concern.

We call for CMS to amend the draft NCD to cover all CDC-recommended ancillary services at the annual frequencies specified in current CDC guidance.

As described in the draft NCD, PrEP encompasses not only medication, but also a suite of ancillary services, including STI testing and counseling, HIV testing (HIV-1 RNA assay), renal function testing, and adherence counseling. These services are required at PrEP initiation and for monitoring at follow-up visits, with a different cadence of testing recommended in the CDC’s most recent guidance for oral and injectable PrEP (4).

We commend CMS’ draft NCD memo for covering up to seven visits annually including HIV risk assessment and adherence counseling, as well as HIV screening seven times a year and HBV screening once a year. However, we urge CMS to clarify that the seven covered HIV screenings encompass both HIV-1 RNA testing—qualitative and quantitative—as well as HIV antibody-antigen testing at frequencies specified in current CDC practice guidelines. We also urge CMS to state explicitly that renal function testing (especially important for older PrEP users) is covered semiannually.

We ask that CMS explicitly cover all ancillary services recommended for people on PrEP within the USPSTF A-rated recommendation for PrEP. Also, since an update to USPSTF’s recommendation is pending (5), we also ask that CMS explicitly incorporate the most recent USPSTF and CDC clinical guidance updates into the NCD. Whenever the standards of care for PrEP change, including ancillary services or frequency of laboratory testing, these new standards should be incorporated without delay into Medicare coverage. Any coverage gaps threaten improved uptake of PrEP and prevention of HIV infection for all Medicare beneficiaries.

We are especially concerned that the draft NCD does not include coverage of required STI tests at the cadence recommended by CDC’s PrEP guidelines.

We are disappointed by CMS’ failure to align Medicare coverage of STI screenings with CDC guidelines for PrEP. CMS’ draft decision memo states that CMS “recognize[s] that the CMS STI screening policy differs from the above CDC recommendations regarding the frequencies of STI screenings and chlamydia and gonorrhea screening in men receiving PrEP,” and also cites USPSTF’s 2021 STI screening recommendations (6) which conclude that the evidence is “insufficient to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men.” Though CMS states that “in the future, we may consider screening for additional populations if recommended with a Grade A or B by the USPSTF,” it is important to recognize that USPSTF already does encompass quarterly chlamydia and gonorrhea screenings for men who have sex with men and transgender women within its A-rating for PrEP. The 2021 STI screening recommendations are superseded for all PrEP patients by the STI screening recommendations in the USPSTF PrEP recommendation (which will be updated later this year).

To state that “diagnostic STI testing may be performed for any sexually active beneficiary with signs or symptoms of infection” is not sufficient. Detection of asymptomatic STI infection—and the resulting decrease of HIV transmission risk—is part of the rationale for quarterly STI testing as recommended in current CDC practice guidelines. We urge CMS to match Medicare coverage with CDC recommendations, as is already done by commercial insurance as well as most state Medicaid programs.

We ask CMS to modify language in the NCD referring to “persons at high risk for HIV acquisition.”

Referring to persons at “high risk” for HIV translates into a variety of harms to people who would benefit from HIV prevention. Many individuals who should be on PrEP to prevent HIV do not perceive themselves as being at “high risk”; additionally, some providers may themselves stigmatize people seen as “high risk.” In addition, many patients do not disclose their sexual or substance use behaviors to their providers. For this reason, the CDC’s most recent PrEP guidelines recommend that PrEP be discussed with all sexually active adults and adolescents, and that PrEP be prescribed to all who request it. Without an explicit endorsement of these principles in the finalized NCD, providers may unnecessarily limit access to PrEP to the many patients who are not comfortable detailing their reason for wanting to be on PrEP. We suggest the NCD use the term “at an increased risk for HIV acquisition” instead.

We urge CMS to incorporate language in the final NCD affirming that prior authorization or other utilization management should not be used for PrEP medications.

Utilization management is not generally employed for HIV drugs in Part D, as specified in the Medicare Prescription Drug Benefit Manual (7). We believe this should also apply to HIV drugs through Part B, including PrEP. We urge CMS to state that utilization management should not be used for PrEP accessed through Part B, whether fee-for-service Part B, or through a Medicare Advantage plan. We also urge CMS not to allow prior authorization for the purpose of assessing HIV risk: this should be the clinician’s determination, not the payor’s.

We urge CMS to resolve implementation issues prior to requiring coverage of oral PrEP medications through Medicare Part B rather than Part D.

While we commend CMS on its bold and innovative move to provide coverage of all forms of PrEP to Medicare beneficiaries without copay by moving all PrEP drugs to Part B (8), we believe there are a number of implementation issues that must be addressed. A transition to coverage of oral PrEP from coverage in Part D to coverage in Part B will require careful implementation and guidance from CMS to ensure that patients, pharmacies, plans, and providers have clarity in the course of a potentially confusing transition. We note that though all pharmacies in the United States may bill Part D, only 76 percent of pharmacies have enrolled to bill Medicare Part B (9), only a few of which will have experience dispensing the few oral self-administered drugs currently available through Part B. Some unenrolled pharmacies are providing PrEP to thousands of PrEP patients who would need to switch if these pharmacies do not enroll to bill Part B, which is more complex and requires more documentation than billing through Part D.

Dispensing oral PrEP through Part B may expose PrEP patients to new obstacles. For instance, Part B medications must be picked up within a day after prescriptions are billed. Pharmacies are only allowed to dispense a 30-day supply, rather than a 90-day supply that PrEP users are accustomed to and prefer. We urge CMS to ensure that 90-day fills of PrEP are available through Part B.

Shipment of PrEP medications by mail and telehealth are of critical importance to PrEP access. CMS must guarantee that mail order shipments of oral PrEP medications through Part B are feasible, including for patients seen by telehealth, to ensure smooth access to oral PrEP through Part B. We encourage CMS to meet with members of the HIV community, pharmacists, providers, plans, and manufacturers to fully understand and prepare for these important implementation issues.

Ultimately, CMS must provide clear guidance for PrEP patients who may be confused by the need to switch pharmacies, as well as to providers, pharmacies, and plans. We urge CMS to eliminate any barriers and disincentives for pharmacies to enroll in Part B billing. While we know that CMS’ goal is to increase access to all forms of PrEP without cost-sharing, we do not want to create any new barriers to accessing oral PrEP.

We would also note that oral HIV treatment and post-exposure prophylaxis (PEP) medications would continue to be available through Part D. Two oral PrEP medications (Truvada, or emtricitabine/tenofovir disoproxil fumarate, and Descovy, or emtricitabine/tenofovir alafenamide fumarate), may also be prescribed as a component of HIV treatment or PEP. We must be certain that Medicare enrollees living with HIV, and those trying to access emergency post-exposure prophylaxis, do not encounter confusion at the pharmacy counter when trying to access their medications. Clear communication and guidance are required so that plans, pharmacy staff, and providers can continue to provide smooth and timely access to each of these important interventions in both Part B and Part D.

If you have any questions or comments, please contact Carl Schmid, HIV+Hepatitis Policy Institute at cschmid@hivhep.org or (202) 462-3042, or Kevin Herwig, HIV+Hepatitis Policy Institute at kherwig@hivhep.org or (617) 666-6634.

Sincerely,

Carl E. Schmid II

References

(1) https://hivhep.org/testimony-comments-letters/64-organizations-request-expedited-medicare-national-coverage-determination-for-long-acting-injectable-prep/

(2) https://hivhep.org/testimony-comments-letters/comments-on-medicare-national-coverage-determination-for-long-acting-injectable-prep/

(3) Proprietary IQVIA data cited in ViiV NCD request, https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id310.pdf (February 2022)

(4) US Public Health Service. Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States: 2021 Update, https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf (December 2021).

(5) United States Preventive Services Task Force, draft update: Prevention of HIV Infection: Pre-Exposure Prophylaxis. https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025. December 2022.

(6) https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/chlamydia-and-gonorrhea-screening

(7) https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/partdmanuals, Chapter 6, Section 30.2.5

(8) https://www.hiv.gov/blog/cms-proposes-medicare-coverage-for-prep-invites-public-comment-by-august-11

(9) Page 3, https://oig.hhs.gov/oei/reports/oei-02-15-00440.pdf

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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 by the Centers for Medicare and Medicaid Services to fully cover pre-exposure prophylaxis (PrEP) for HIV prevention for beneficiaries under Medicare Part A and Part B. Several years ago Fenway Health encouraged the United States Preventive Services Task Force (USPSTF) to grant PrEP a Grade A recommendation for persons at high risk of Human Immunodeficiency Virus (HIV) acquisition. We are especially supportive of CMS’s explicit specifications around coverage of oral as well as injectable PrEP, of coverage without cost sharing of peripheral costs such as counseling visits, and of the additional screening (up to seven times annually) for HIV including lab testing costs.

As we focus on reaching people at risk for HIV, barriers to accessing care perpetuate the disparities that low-income and marginalized populations experience. Reducing as many barriers as possible, by expanding coverage, can help to reduce disparities in PrEP uptake and use across race and ethnicity, sexual orientation, and gender identity. In 2020, only 35% of men who have sex with men and 7% of all individuals (approximately 1.1 million people) in the U.S. who could benefit from PrEP had been prescribed PrEP. ,

The Centers for Disease Control and Prevention (CDC) predict that, if current trends persist, 1 in 6 men who have sex with men (MSM) in the U.S. will become HIV-infected in their lifetime. Within the MSM population, there are striking racial/ethnic disparities: 1 in 11 White non-Hispanic MSM will become infected, compared to 1 in 4 Latino MSM and 1 in 2 Black MSM. Of the 39,782 new HIV infections that occurred in the United States in 2016, nearly half were among Black or Latino MSM, and 52% occurred in the South. Transgender women, and especially Black and Latina transgender women, are also disproportionately vulnerable to HIV infection, although less surveillance data is available on the transgender population.

Black Americans are less likely to access PrEP for a number of reasons, including the fact that half of Black Americans live in the South, where by and large Medicaid has not been expanded to low-income individuals without dependent children or a disability. Higher poverty and unemployment rates among Black Americans also play a role. Medical mistrust is another barrier that prevents Black people, including Black gay and bisexual men, from accessing routine, preventive health care. Finally, lack of culturally competent health care for Black LGBT people is a barrier to access.

The proposed coverage of this CMS proposal can address the cost sharing associated with both the medication and the clinic and lab visits, that have been persistent barriers.

Injection drug use as the mode of transmission for people who are newly diagnosed with HIV continues to grow. The efficacy of oral PrEP for people who inject drugs (PWID) is around 70%. When compared to the over 90% efficacy of oral PrEP for sexual transmission, many factors need to be considered including low levels of knowledge, low HIV risk perception, HIV stigma, concerns about side effects, poor clinical infrastructure and capacity to deliver PrEP to PWID, and challenges related to drug dependence, homelessness, lack of identification, and other issues. , For some PWID, their lives are often so chaotic that taking a pill every day at the same time is not realistic. For individuals who are unhoused or living in the shelter system, it is very hard to keep pills. The reality is that pills are often stolen. Injectable, long-acting PrEP will be especially important for HIV prevention and has the potential to improve the level of efficacy for PWID. It will also benefit others who are at elevated risk for HIV and homelessness, including many individuals who do not use injection drugs.

Coverage of peripheral costs, like counseling, screening, and lab costs is essential to ensuring people at risk for acquiring HIV remain engaged in the continuum of care. This recommendation covers screening for HIV but we strongly suggest that it also include screening and testing for sexually transmitted infections (STIs). People on PrEP are at risk for gonorrhea, chlamydia, syphilis, and other STIs.

Here at Fenway Health, the cost of testing routinely comes up as insurers are frequently denying them as preventative, based on diagnosis codes, applying criteria which sometimes changes. What worked one time might not work the next time. It is important to cover the costs for the laboratory monitoring tests in addition to the medication itself. With the CDC's recommendations to do HIV RNA testing at every PrEP dispensing visit, and quarterly testing for gonorrhea and chlamydia from all anatomically appropriate sites, the costs of just monitoring a patient on PrEP will easily get into the $5000 range annually. There is a potential major out of pocket expenditure for consumers, ensuring coverage of monitoring costs can help with this barrier to access continued preventative care.

The decision to initiate PrEP is often long, thoughtful, and involves many conversations that build trust between a patient and their provider. Hurdles created by lack of coverage in the process put the sometimes-delicate decision at risk for a patient who can benefit from PrEP. For patients who are not regularly engaged with a primary care provider, the opportunity to initiate PrEP may not come again soon. This includes many people who fall into high-risk demographics: people who inject drugs and people experiencing homelessness. Hiccups in the process can also break the trust that a provider must build over time. The public health HIV prevention concept of Undetectable = Untransmittable (U=U) is only possible with reliable adherence to treatment, through regular visits with a provider. Additional and unforeseen costs or delays after a patient’s decision to initiate PrEP can derail the treatment plan and negatively impact efficacy.

Coverage of the services that are integral to the PrEP intervention detailed in this proposal, in addition to the medication itself, are essential. To ensure meaningful access to PrEP, and to avoid a “bait and switch” for consumers seeking a prescription for PrEP with the understanding that it is available without cost sharing, these services must be covered without cost sharing and we applaud this inclusion in the proposal.

When considering the disparities in access to PrEP that persist, the increased demand that greater access will create, and the additional need for scaled up access, our clinical staff at Fenway also recommend language that includes reimbursement of visits run by a nurse in addition to provider-led visits. Ensuring that individuals remain on PrEP requires consistent access to these visits; We at Fenway have already implemented and are continuing to expand on nurse-led PrEP and follow-up visits to address the increasing need. We are currently doing this through state-funded programs and would welcome more inclusive reimbursement of visits for counseling and monitoring that may be run by a nurse.

One concern that we want to raise with CMS, based on the experience of Fenway Health clinicians who struggle to prescribe injectable PrEP to vulnerable patients, is prior authorization. Prior authorization is not an appropriate utilization management tool to identify individuals indicated for PrEP. Determination of risk for HIV and appropriateness of PrEP is a clinical decision, to be made by prescribers. Utilization management techniques that attempt to restrict access to PrEP using prior authorization perpetuate stigma and encourage plan designs that discriminate against LGBT individuals. To increase access to all forms of PrEP (oral as well as injectable), regulators should explicitly prohibit use of prior authorization for PrEP as a way to identify individuals at high risk for HIV.

Providers at Fenway Health and elsewhere have experienced significant barriers to prescribing long-lasting injectable PrEP, including onerous prior authorization requirements which force providers to spend hours on the phone seeking insurance approval. Often insurance companies require that a patient first try oral PrEP and that the clinician attest that adherence to oral PrEP was unsuccessful for the patient. For homeless patients and patients who inject drugs, this requirement can prevent them from accessing PrEP and cause them to become infected with HIV, Hepatitis C, and other pathogens. We hope that the proposed Grade A rating for injectable and oral PrEP will reduce these time-consuming and wasteful prior authorization requirements, which can serve as a barrier to accessing injectable PrEP, especially for populations who are historically challenging to engage and retain in care.

Fenway Health has two in-house pharmacies, which are currently enrolled to bill to Medicare Part D. Our pharmacy staff have flagged an unintended consequence in expanding access to PrEP through Medicare Part B: while all pharmacies in the U.S. can bill Part D, only 76% are set up to bill Part B. While some pharmacies with a large enough PrEP patient panel may be able to overcome the obstacles and cost of enrolling to bill Part B, not all can. Some of the smaller local pharmacies who currently dispense PrEP, may no longer have the option to do so sustainably. If they do not have enough patients on PrEP that will generate enough reimbursement revenue, the expense to enroll will not be financially worth it. This may result in fewer pharmacies providing it, which, counter to the intent of this recommendation, will narrow some patients’ access. Please consider pharmacies’ access to enrollment in Medicare Part B, so that they may participate in this improvement and provide increased access to PrEP.

We support the proposal to provide coverage of PrEP (whether oral or injectable) and peripheral screening, lab and counseling costs. Should you have any questions, please contact Carrie Richgels, Manager of Policy and Advocacy, at crichgels@fenwayhealth.org. Thank you for considering this comment.

Ellen LaPointe
Chief Executive Officer, Fenway Health

Jane Powers
Executive Vice President, Fenway Health

Amy Whitcomb Slemmer
Chief Compliance Officer and Interim EVP of External Relations, Fenway Health

Ken Mayer
Medical Research Director, Fenway Health
Co-Chair and Medical Research Director, The Fenway Institute
Professor of Medicine, Harvard Medical School
Attending Physician, Infectious Disease Division, Beth Israel Deaconess Hospital

Jennifer Potter
Co-Chair and LGBT Population Health Program Director, The Fenway Institute
Professor of Medicine, Harvard Medical School

Jessica Kraft
Biomedical Research Clinician, The Fenway Institute

Taimur Khan
Associate Medical Research Director, The Fenway Institute

Juan Jaime de Zengotita
Medical Director, Fenway Health

Carrie Richgels
Manager of Policy and Advocacy, Fenway Health

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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 pill or an injection; it is a comprehensive intervention comprised of medication and essential support services.

NCSD is a cosigner of the comment submitted by the HIV Health Care Access Working Group, the HIV Prevention Action Coalition, and the Federal AIDS Policy Partnership, and submits this additional comment to expand upon the importance of covering routine STI screening for patients receiving PrEP.

We urge CMS to amend the proposed Decision to explicitly cover up to four STI screenings annually for people receiving PrEP and ensure that three-site STI testing (pharyngeal, rectal, and urine specimens) will be covered, following the 2021 CDC guidelines.

I. Bacterial STIs such as gonorrhea and syphilis correlate with a higher risk of HIV acquisition and must be closely monitored in patients on PrEP.
Having an STI makes someone three to five times more likely to acquire HIV.(1) And studies have indicated that over the course of a year, nearly half of people on PrEP will be diagnosed with an STI.(2) Only screening for STIs annually or when a patient presents with symptoms (Medicare’s current coverage) will leave many on PrEP without the treatment they need. A 2022 study found that although the risk was slightly lower for older individuals, reducing the frequency of STI screenings for people using PrEP from quarterly to biannually (contrary to CDC guidelines) would lead to a delayed diagnosis in over 50% of asymptomatic STIs and 32% of symptomatic and asymptomatic STIs.(3)

II. The proposed decision is inconsistent with HHS policy.
In 2021, CMS issued FAQs about Affordable Care Act Implementation Part 47, which—in part—clarified if insurers and payers must cover PrEP as a comprehensive intervention, and what items or services insurers and plans must cover without cost sharing in light of the 2019 USPSTF “A” rating for PrEP. In response to the question, CMS explicitly stated, “Yes. As described in the USPSTF Final Recommendation Statement, the purpose of the recommendation is to decrease the risk of HIV transmission for persons who are at high risk of HIV infection. The USPSTF also notes that ‘the CDC provides a complete discussion of implementation considerations for PrEP, including baseline and follow-up testing and monitoring, time to achieving protection, and discontinuing PrEP.’ The USPSTF recommendation cites CDC guidelines, which advise that PrEP is a comprehensive intervention comprised of antiretroviral medication and essential support services (including medication self-management/ adherence counseling, risk reduction strategies, and mental health counseling, etc.) that ensure PrEP is administered safely and effectively to persons who need it. Consistent with the CDC’s advice, the USPSTF recommendation for PrEP includes a combination of baseline and monitoring services (described below), which are essential to the efficacy of PrEP...”(4)

Elsewhere in its response, CMS outlines the specific baseline and monitoring services that must be covered without cost sharing,
“Sexually transmitted infection (STI) screening and counseling: Persons taking PrEP must be screened for STIs at baseline and should be screened periodically thereafter consistent with CDC guidelines, which may require multiple anatomic site testing (i.e., genital, oropharyngeal, and rectal) for gonorrhea and chlamydia, and testing for syphilis, together with behavioral counseling, which are recommended to reduce the risk of STIs, the presence of which may increase the likelihood of acquiring HIV sexually.”(5)

The CDC guidelines mentioned by CMS and in the USPSTF guidelines are clear and the frequency of STI screening for patients on PrEP is population specific. As components of ongoing oral PrEP care, the current CDC Guidelines recommend the following: quarterly bacterial STI screening for MSM and transgender women who have sex with men – oral, rectal, urine, blood; semi-annual bacterial STI screening for all sexually active patients – (vaginal, oral, rectal, urine as indicated), blood; and annual chlamydia screening for heterosexually active women and men – vaginal, urine.(6) As components of ongoing injectable PrEP care, the CDC Guidelines recommend the following: triannual bacterial STI screening for MSM and transgender women who have sex with men – oral, rectal, urine, blood. semi-annual bacterial STI screening for all sexually active patients – (vaginal, oral, rectal, urine as indicated), blood, and annual chlamydia screening for heterosexually active women and men – vaginal, urine.(7)

III. The cost of the HIV-STI syndemic is high.
The lifetime medical costs of new STIs acquired in 2018 totaled nearly $16 billion, with chlamydia, gonorrhea, and syphilis accounting for $1.1 billion.(8) And in 2018, the lifetime medical costs for 1,896 new HIV infections attributed to chlamydia, gonorrhea, and syphilis totaled $800 million.(9) STI incidence in PrEP users is high, with roughly 50% of PrEP users receiving an STI diagnosis each year.(10) Early diagnosis and treatment for those bearing the burden of America’s STI crisis is critical.

IV. CMS’s reliance on USPSTF’s ratings for STI screening in this Decision is misplaced.
The proposed Decision states that increasing the frequency of screenings is outside the scope of this decision, and justifies that decision based on USPSTF ratings for STI screenings. However, USPSTF ratings on STI screening do not consider people’s existing medications, and nor should they; they are intended as ratings for the general public. Therefore, the USPSTF ratings for STI screenings should have no bearing on CMS’s Decision in this matter. Instead, CMS should follow the USPSTF recommendation for PrEP, which clearly cites the CDC guidelines shared above. Recommendations, and thus coverage, for general populations and people at increased risk for HIV on PrEP must be discerned separately.

CMS’s proposed national coverage decision recognizes PrEP only as a medication, not as the comprehensive intervention that has been articulated in CDC guidelines and reaffirmed by CMS. Coverage of annual STI screenings is insufficient for the population served by PrEP and is simply bad care and bad policy. CMS’s final decision must cover up to four STI screenings annually for those on PrEP, and must ensure those screenings are thorough by supporting three-site testing.

Thank you for your consideration. If you have any questions, please contact NCSD’s director of federal policy, Rachel Deitch at rdeitch@ncsddc.org

Endnotes:

(1) Wasserheit, Judith N. “Epidemiological Synergy.” Sexually Transmitted Diseases, vol. 19, no. 2, 1992, pp. 61–77, https://doi.org/10.1097/00007435-199219020-00001. Fleming, D. T., and J. N. Wasserheit. “From Epidemiological Synergy to Public Health Policy and Practice: The Contribution of Other Sexually Transmitted Diseases to Sexual Transmission of HIV Infection.” Sexually Transmitted Infections, vol. 75, no. 1, 1999, pp. 3–17, https://doi.org/10.1136/sti.75.1.3.
(2) Traeger, Michael W., et al. “Association of HIV Preexposure Prophylaxis with Incidence of Sexually Transmitted Infections among Individuals at High Risk of HIV Infection.” JAMA, vol. 321, no. 14, 2019, p. 1380, https://doi.org/10.1001/jama.2019.2947. McManus, Hamish, et al. “Comparison of Trends in Rates of Sexually Transmitted Infections before vs after Initiation of HIV Preexposure Prophylaxis among Men Who Have Sex with Men.” JAMA Network Open, vol. 3, no. 12, 2020, https://doi.org/10.1001/jamanetworkopen.2020.30806.
(3) Jongen, Vita W., et al. “Can We Screen Less Frequently for STI among Prep Users? Assessing the Effect of Biannual STI Screening on Timing of Diagnosis and Transmission Risk in the AMPREP Study.” Sexually Transmitted Infections, 2022, https://doi.org/10.1136/sextrans-2022-055439.
(4) FAQs About Affordable Care Act Implementation Part 47, 19 July 2021, www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-49.pdf.
(5) Ibid.
(6) Centers for Disease Control and Prevention. US Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline, 2021, www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf.
(7) Ibid.
(8) Chesson, Harrell W., et al. “The Estimated Direct Lifetime Medical Costs of Sexually Transmitted Infections Acquired in the United States in 2018.” Sexually Transmitted Diseases, vol. 48, no. 4, 2021, pp. 215–221, https://doi.org/10.1097/olq.0000000000001380.
(9) Ibid.
(10) Traeger, Michael W., et al. “Association of HIV Preexposure Prophylaxis with Incidence of Sexually Transmitted Infections among Individuals at High Risk of HIV Infection.” JAMA, vol. 321, no. 14, 2019, p. 1380, https://doi.org/10.1001/jama.2019.2947. McManus, Hamish, et al. “Comparison of Trends in Rates of Sexually Transmitted Infections before vs after Initiation of HIV Preexposure Prophylaxis among Men Who Have Sex with Men.” JAMA Network Open, vol. 3, no. 12, 2020, https://doi.org/10.1001/jamanetworkopen.2020.30806.

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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 2019, HIV incidence increased 15% among that age group (more than any other age group in that period). Based on this data, it is clear that there’s significant need for access to HIV prevention tools like PrEP in the Medicare population.

However, we believe that the NCA is not clear with respect to coverage of sexually transmitted infection (STI) screenings and other laboratory tests that are required for patients to safely initiate and remain on PrEP. Although the NCA states that these tests “may be ordered at the physician or health care practitioner’s discretion under existing Medicare coverage,” it does so too briefly and too late in the Analysis to make clear that the tests are eligible to be covered. Lab tests are an integrated part of the PrEP regimen. A lack of coverage for them will have the effect of discouraging people from initiating, or causing them to discontinue, PrEP due to cost. Multiple studies have identified costs associated with PrEP, including the cost of ancillary services, as a barrier to initiation and or adherence. [1,2] Therefore, we urge CMS to explicitly, prominently state in the final National Coverage Determination that STI screenings, kidney-function testing, and all other recommended PrEP services are covered.

Thank you for your consideration.

[1] Srikanth K, Killelea A, Strumpf A, Corbin-Gutierrez E, Horn T, McManus KA. Associated Costs Are a Barrier to HIV Preexposure Prophylaxis Access in the United States. Am J Public Health. 2022 Jun;112(6):834-838. doi: 10.2105/AJPH.2022.306793. Epub 2022 Apr 14. PMID: 35420893; PMCID: PMC9137017.

[2] Antonini M, Silva IED, Elias HC, Gerin L, Oliveira AC, Reis RK. Barriers to Pre-Exposure Prophylaxis (PrEP) use for HIV: an integrative review. Rev Bras Enferm. 2023 Jun 26;76(3):e20210963. doi: 10.1590/0034-7167-2021-0963. PMID: 37377313; PMCID: PMC10292616

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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 centers also provide public education on LGBTQ issues, advocate for social change, and engage with community leaders and decision-makers, all of which is grounded by their daily experiences working with diverse LGBTQ communities.

We are writing in support of the National Coverage Determination (NCD) to cover all forms of PrEP under Medicare. In our experience, many of our LGBTQ community center's clients who would benefit from PrEP are unable to access it due to numerous barriers. These include costs of PrEP itself, the costs of related lab work, lack of knowledge among providers, inability to access medical appointments, and inability to stay adherent to medications due to factors such as housing instability or difficulty remembering. Therefore, having as many options open as possible for community center clients – including injectable PrEP, which would be covered under the NCD – is important.

The bulk of Medicare recipients are those who qualify based on age, and while older adults are often not prioritized for HIV prevention and care, the CDC has estimated that over half of people diagnosed with HIV are aged 50 and older. In addition, LGBTQ adults who are over 65 and thus qualify for Medicare based on age have significant barriers to accessing services of all types, given factors such as stigma and social isolation. This population would especially benefit from having Medicare cover all types of PrEP.

In addition to strongly supporting the NCD overall, we also encourage CMS to consider clarifying that laboratory costs associated with PrEP also be covered, as this proves to be a barrier for those seeking to access PrEP. The inclusion of up to seven individual counseling visits per year is an important step, especially for those for whom free testing is less convenient or more stigmatizing; however, laboratory costs can prove even more prohibitive.

In conclusion, in our opinion as an organization supporting over 300 LGBTQ community centers, many of whom have clients who would most benefit from PrEP access – among whom nationwide only 25% are currently benefiting – we believe the NCD to be an important step forward in ending the HIV epidemic. We hope that the NCD will be finalized, ideally with clear inclusion of laboratory costs, and that this might spur further change to increase access to this critical preventive measure.

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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. Current coverage for PrEP is confusing to prescribing providers and patients that would benefit from taking PrEP (Mayer et al., 2020). Many states or healthcare organizations require PrEP navigators to help facilitate insurance coverage for this preventative medication because the process is complicated. Each type of insurance can have a different process and coverage for the medication and the recommended testing, deterring providers and clients from using it. Increasing coverage of PrEP and testing around PrEP by the CMS will reduce confusion and encourage providers and clients to utilize this HIV prevention tool.

Currently CMS does not provide coverage for all of the Clinical Practice Guidelines as recommended in the CDC’s Preexposure Prophylaxis for the Prevention for HIV Infection in the United States – 2021 Update. Coverage for PrEP and all recommended testing is imperative to end the HIV Epidemic by 2030 (CDC, 2021).

In addition to increasing coverage for oral and injectable PrEP, I believe STI screenings, Hep B, Hep C, and renal screening recommended in the CDC’s PrEP clinical guidelines 2021 update be considered. In addition to testing, I believe risk reduction and medication adherence counseling should be increased to more than 2x per year and match the CDC’s PrEP and STI clinical Guidelines.

The new proposed rule to increase coverage for oral and injectable PrEP is one step closer to ensuring patients utilizing CMS can get care as the CDC recommends. I support this change and suggest further changes be considered to match the CDC’s guidelines. Aligning the goals of federal government agencies will be the most cost-effective and impactful way to reach a targeted goal like ending the HIV Epidemic.

References

Center for Disease Control and Prevention. (2021). US public health services preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update a clinical practice guideline. US Public Health Service: PREEXPOSURE PROPHYLAXIS FOR THE PREVENTION OF HIV INFECTION IN THE UNITED STATES – 2021 UPDATE, A CLINICAL PRACTICE GUIDELINE (cdc.gov)
Center for Disease Control and Prevention. (2021). Sexually transmitted Treatment Guidelines, 2021. Retrieved August 10, 2023, from Table of Contents - STI Treatment Guidelines (cdc.gov)
Marks, S. J., Merchant, R. C., Clark, M. A., Liu, T., Rosenberger, J. G., Bauermeister, J., & Mayer, K. H. (2017). Potential healthcare insurance and provider barriers to pre-exposure prophylaxis utilization among young men who have sex with men. AIDS patient care and STDs, 31(11), 470–478. https://doi.org/10.1089/apc.2017.0171
Mayer, K. H. Agwu, A., & Malebranche, D. (2020). Barriers to the wider use of pre-exposure prophylaxis in the United States: A Narrative review. Advances in Therapy 37(5), 1778—1811. https://doi.org/10.1007/s12325-020-01295-0
Medicare Interactive. (2023). Sexually transmitted infection (STI) screening and counseling. Medicare Rights Medicare Interactive. Retrieved August 10, 2023, from Sexually transmitted infection (STI) screening and counseling - Medicare Interactive
Unger, Z. D., Golub, S. A., Borges, C., Edelstein, Z. R., Hedberg, T., & Myers, J. (2022). Reasons for PrEP discontinuation after navigation at sexual health clinics: Interactions among systemic barriers, behavioral relevance, and medication concerns. Journal of Acquired Immune Deficiency Syndromes (2022), 90(3), 316–324. https://doi.org/10.1097/QAI.0000000000002952
Zhang, H. L., Rhea, S. K., Hurt, C. B., Mobley, V. L., Swygard, H., Sena, A. C., & McKellar, M. S. (2018). HIV pre-exposure prophylaxis implementation at local health departments: A statewide assessment of activities and barriers. Journal of Acquired Immune Deficiency Syndrome 77(1), 72-77. https://doi.org/10.1097/QAI.0000000000001546

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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 comes to PrEP. Perhaps most importantly, one of our most used services at the center is our referral program. This program helps to connect our LGBTQ+ community members with healthcare providers that are knowledgeable and affirming.

We are writing in support of the National Coverage Determination (NCD) to cover all forms of PrEP under Medicare. In our experience, our community members who would benefit from PrEP are unable to access it due to numerous barriers. These include costs of PrEP itself, the costs of related lab work, lack of knowledge among providers, inability to access medical appointments, and difficulty staying adherent to medications due to factors such as housing instability or mental illness. Therefore, having as many options open as possible for our clients – including injectable PrEP, which would be covered under the NCD – is important.

The bulk of Medicare recipients are those who qualify based on age, and while older adults are often not prioritized for HIV prevention and care, the CDC has estimated that over half of people diagnosed with HIV are aged 50 and older. In addition, LGBTQ+ adults who are over 65 and thus qualify for Medicare based on age have significant barriers to accessing services of all types, given factors such as stigma, social isolation, and the potential for other chronic health concerns. This population would especially benefit from having Medicare cover all types of PrEP.

In addition to strongly supporting the NCD overall, we also encourage CMS to consider clarifying that laboratory costs associated with PrEP also be covered, as this proves to be a barrier for those seeking to access PrEP. Additionally, the inclusion of up to seven individual counseling visits per year is an important step, especially for those for whom free testing is less convenient or more stigmatizing; however, laboratory costs can prove even more prohibitive.

In conclusion, as an organization serving many people who would most directly benefit from PrEP access – among whom nationwide only 25% are currently benefiting – we believe the NCD to be an important step forward in ending the HIV epidemic and supporting patients at risk for HIV. We hope that the NCD will be finalized, ideally with clear inclusion of laboratory costs, and that this might spur further change to increase access to this critical preventive measure.

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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 out-of-pocket costs, including the cost of ancillary services. We applaud the decision by CMS to expand access to this lifesaving medication and urge the administration to take additional steps to ensure all forms of FDA-approved PrEP medication are available without cost-sharing to those who need it.

PrEP is highly effective at preventing the transmission of HIV. Despite this, the medication remains highly underutilized in the United States, particularly among people of color. According to the Centers for Disease Control and Prevention (CDC), in 2021, only 30 percent of the 1.2 million people for whom PrEP was recommended were prescribed it. While Black individuals and Hispanic and Latino individuals account for the majority of people for whom PrEP is recommended, only 11 percent and 21 percent, respectively, of Black individuals and Hispanic and Latino individuals who could benefit from PrEP were prescribed it in 2021. By comparison, 78 percent of white individuals eligible for PrEP in 2021 were prescribed it.

These disparities are partially driven by limited coverage of PrEP medication, including the lab tests and follow-up visits required for using these medications, by payers. Currently, Medicare beneficiaries can only access daily oral PrEP under Medicare Part D, resulting in out-of-pocket costs. The NCD expands access to long-acting injectable PrEP, which many patients may prefer based on convenience, for Medicare beneficiaries. Eliminating cost-sharing for ancillary services – including counseling visits and HIV and hepatitis B testing – will help reduce financial barriers and incentivize uptake among those for whom the medication is recommended. In the final NCD, we encourage CMS to mirror CDC recommendations regarding the need for and frequency of STI testing, as well as recommendations related to identifying who is eligible for PrEP.

We believe that every individual in the United States who is considered at-risk for HIV should have access to the preventative health care services they need, including PrEP, without out-of-pocket costs. This proposed rule takes a critical step in achieving universal access for these patients. We strongly urge CMS to finalize and implement this proposed National Coverage Determination and encourage the administration to take additional steps to eliminate out-of-pocket costs, including enforcement of existing requirements for insurers, in order to reduce barriers that limit access to HIV preventative services for Americans.

We look forward to working with you on this important issue.

Sincerely,

Adam B. Schiff                   Tina Smith
Member of Congress         United States Senator

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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 Virus (HIV) Infection (CAG-00464N) [1].
We applaud the Centers for Medicare & Medicaid Services' (CMS) recognition that PrEP is a prevention modality that includes biomedical interventions, ancillary testing and screening, as well as medication adherence and risk reduction counseling. Medicare’s coverage of both oral and injectable PrEP, alongside non-pharmaceutical services as a Part B preventive service will significantly improve access to PrEP while addressing disparities in access that exist today for Medicare enrollees who cannot afford the costs associated with oral PrEP under Part D or ancillary testing and screening under Part B. The NCD can also help to address disparities in HIV infection among Black and Hispanic individuals who have infection rates up to eight times higher than white individuals [2]. Importantly, as HIV incidence is rising among those age 50 and over, this NCD represents a significant step towards eliminating discrimination in coverage based on ageist and ableist views of older adults’ and disabled people’s sexuality and behaviors [3].

We offer the following comments with the aim to ensure that the NCD is best positioned to achieve equitable access to PrEP for all Medicare enrollees.

The NCD Must Include STI Screenings and Laboratory Testing
In order to ensure that Medicare enrollees do not face unanticipated costs or continued barriers to PrEP, we strongly urge CMS to include screenings for sexually transmitted infections (STIs) and other laboratory testing in this NCD. STI panel screenings and other laboratory testing are currently recommended in the PrEP practice guidelines set forth by both the Centers for Disease Control and Prevention (CDC) and the United States Preventive Services Taskforce (USPTF) [4]. These tests are also required under the Affordable Care Act’s coverage of PrEP [5]. To adhere to current practice guidelines and consistent with other health insurance coverage, practitioners will order these tests for all those receiving PrEP, including people with Medicare. If coverage for this testing is excluded by the NCD, Medicare enrollees will face unanticipated and potentially unaffordable out-of-pocket costs reducing the likelihood that they will remain on PrEP and undermining the goal of the NCD.

Accordingly, we strongly recommend that CMS include in the final NCD STI panel screenings, which should include chlamydia, gonorrhea, and syphilis screens; annual kidney function assessments and 6-month kidney function assessments for adults over age 50, measured by creatine ratio; pregnancy tests, and annual urine glucose and urine protein assessments that align with CDC clinical practice guidelines. Including coverage of STI screenings and other laboratory testing as part of the PrEP modality is squarely within the scope of this NCD. We separately urge CMS to address STI screenings more broadly beyond PrEP through revisions to NCD 210.10 in the future.

We appreciate that CMS proposes to cover seven HIV screenings and counseling sessions in the NCD. CMS should consider adding an exception for coverage beyond seven covered screenings and counseling services when medically necessary as documented by a Medicare enrollee’s health provider. There are instances in which testing may be needed on a more frequent basis to ensure HIV positive people do not remain on PrEP including, for example, when a person has a partner they know to be HIV positive.

CMS Must Provide Strong Oversight in Implementation of the NCD
We anticipate that adding PrEP as a preventive service covered under Medicare will increase access to PrEP. Yet, as with any significant change, unforeseen barriers can often arise in implementation. For example, in Medicaid and private insurance coverage we hear reports that people receiving PrEP face charges for ancillary testing when providers improperly bill the tests under diagnostic, instead of preventive, billing codes. Pharmacies may also improperly attempt to bill oral PrEP under Part D instead of Part B. We urge CMS to include in its implementation instructions accompanying the NCD education of enrollees, providers engaged in the provision of PrEP including clinical laboratory testing providers, pharmacies, Medicare Advantage plans, and State Health Insurance Assistance Programs. We also urge CMS to monitor access to PrEP in Medicare Advantage to ensure that managed care organizations are not improperly employing utilization management for PrEP, improperly denying coverage for PrEP, or creating other barriers to access that reflect impermissible departures from Original Medicare coverage standards or discriminatory plan design.

CMS Should Allow for Future Innovation Where Possible
We urge CMS to embed flexibility for future advances in HIV prevention into this NCD and to include language directing revision as needed in light of ongoing developments in the science of HIV and AIDS prevention.

Conclusion
We commend CMS’s efforts to improve access to PrEP through Medicare coverage and to increase equity, financial stability, and well-being for older adults and people with disabilities. If you would like to discuss our comments further or have any questions, please contact Amber Christ at achrist@justiceinaging.org or Julie Carter at jcarter@medicarerights.org.

[1] Justice in Aging is an advocacy organization with the mission of improving the lives of low-income older adults nationwide. We use the power of the law to fight senior poverty by securing access to affordable health care, economic security, and the courts for older adults with limited resources, particularly populations that have been marginalized and excluded from justice, such as people of color, people with disabilities, LGBTQ individuals, and people with limited English proficiency. We have decades of experience with Medicare and Medicaid and working with advocates who represent low-income older adults. The Medicare Rights Center is a national, nonprofit organization that works to ensure access to affordable and equitable health care for older adults and people with disabilities through counseling and advocacy, educational programs, and public policy initiatives. Each year, Medicare Rights provides services and resources to over three million people with Medicare, family caregivers, and professionals.

[2] Centers for Disease Control & Prevention, “HIV Surveillance Supplemental Report,” at 6 (vol. 26, no. 1, May 2021), available at https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-26-1.pdf.

[3] Centers for Disease Control & Prevention, “HIV Surveillance Supplemental Report,” at 5, 17-19, 31 (vol. 26, no. 1, May 2021), available at https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-26-1.pdf.

[4] Centers for Disease Control & Prevention, “Preexposure Prophylaxis for the Prevention of HIV Infection in the United States – 2021 Update: A Clinical Practice Guideline,” available at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf; USPTF, “Prevention of HIV Infection: Pre-Exposure Prophylaxis,” (2022), available at https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/prevention-human-immunodeficiency-virus-hiv-infection-prep#fullrecommendationstart.

[5] Dept. of Health & Human Services, Dept. of Labor, and Dept. of Treasury, “FAQs About the Affordable Care Act Implementation Part 47,” (July 19, 2021), available at https://www.dol.gov/sites/dolgov/files/EBSA/about-ebsa/our-activities/resource-center/faqs/aca-part-47.pdf.

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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 Chin:

The American Pharmacists Association (APhA) is pleased to submit comments on the Proposed Decision Memo (CAG-00464N) “Proposed National Coverage Determination for Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention.”

APhA is the largest association of pharmacists in the United States advancing the entire pharmacy profession. APhA represents pharmacists in all practice settings, including but not limited to community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health.

Pharmacists make up the third largest health care profession and have the second most training behind physicians, graduating with a Doctor of Pharmacy (PharmD) degree. Some pharmacists pursue additional training through one to two-year postgraduate pharmacy residency programs. With extensive training in the properties and appropriate use of medications, their application to acute and chronic disease management, and prevention and wellness services, pharmacists provide a variety of primary health care services, in coordination and collaboration with others in their communities. These services include: chronic condition management where medications are a treatment modality; medication management services – optimizing medication regimens and addressing medication safety issues; coordinating medications during care transitions; providing patient education; delivering prevention and wellness services, including vaccinations and health screenings; conducting point-of-care testing; and treating minor illnesses, where authorized.

As one of the most accessible and trusted health care providers in their communities, pharmacists have a significant role to contribute in initiating access to HIV PrEP and post-exposure prophylaxis (PEP) and providing culturally competent and culturally sensitive care. Nearly 90% of the U.S. population lives within five miles of a community pharmacy and this high level of accessibility allows pharmacists to serve in a unique role as another point of entrance for patients to get integrated into longitudinal and acute HIV preventative services. Programs allowing pharmacists to furnish an initial supply of HIV PrEP/PEP and then refer patients to longitudinal care provided by community-based organizations and primary care providers have expanded across the country in the past ten years. Currently, pharmacists in 17 states have expanded authority to provide HIV PrEP and/or PEP through independent prescriptive authority, protocols, standing orders, or other means. Pharmacists in every state have the authority to administer injectable medications, however, there are variances between states in the type of medications that can be administered and how they are administered. Leveraging the current health care workforce, including pharmacists, is a key component of the National HIV/AIDS Strategy to increase access to HIV PrEP/PEP. The Strategy emphasizes the role of pharmacies in increasing access to a variety of HIV prevention and care services such as testing, PrEP education and initiation, medication education, and adherence counseling, and playing a key role in the re-engagement of patients who have fallen out of care. Recent studies have emphasized the key role that pharmacies play in delivering HIV prevention and care services to people in communities. A CDC study focusing on COVID-19 found that patients visit their community pharmacies 12 times more frequently than their primary care provider.

Recently, the White House Office of National AIDS Policy, in conjunction with the U.S. Business Action to End HIV, and the Elton John AIDS Foundation, convened leaders from across the pharmacy sector at the American Pharmacists Association headquarters in Washington, D.C. to explore opportunities to expand the role of community pharmacies and pharmacists in HIV prevention and care. The meeting included 40 individuals representing major retail pharmacies (Avita Care Solutions, CVS Health, Walgreens, and Walmart), community pharmacy representatives, affiliated associations, the federal government, and experts. The meeting focused on opportunities and challenges and included action planning for joint work to increase services provided in communities by pharmacists and pharmacy technicians.

Despite expansions in pharmacists’ authorities to prescribe these lifesaving medications, there are current barriers that can decrease patients’ accessibility to HIV PrEP/PEP. Two primary barriers to patients’ accessibility of HIV PrEP/PEP include adequate coverage of the dispensing of the medication under the medical benefit and coverage of the pharmacists’ services in the prescribing, and in some cases administration, of the medication under the medical benefit.

Adequate coverage of the medication under the medical benefit
We recommend CMS initiate a National Coverage Analysis for provider-administered PrEP and that coverage result in consistent, transparent, fair, and sustainable reimbursement rates for the medication ingredient. It is necessary to mandate adequate reimbursement for the dispensing of medications to ensure a predictable environment for providers and community pharmacies to operate and minimize the risk of further healthcare setting closure. In line with the White House’s National HIV/AIDS Strategy, APhA strongly recommends that coverage of provider-administered PrEP fall, including pharmacist prescribing and administration where appropriate, according to state pharmacist scope or practice laws, within Medicare Part B, consistent with how Medicare covers other provider-administered medications.

Coverage of the pharmacists’ services under the medical benefit
As stated in the National Academies of Sciences, Engineering, and Medicine (NASEM) report, “The greatest challenge to integrating the role of the pharmacist in primary care relates to financing barriers…” Pharmacists and their services are not currently recognized in Medicare Part B, and coverage is variable in state Medicaid and private sector plans indicating inequitable access to coverage of pharmacist-provided patient care services. Lack of payment to cover the pharmacist’s time to deliver professional services is a significant barrier that must be addressed to fully utilize pharmacists as medication experts. Overall, it is vital that CMS establish a pathway for the reimbursement of pharmacists’ services for both the evaluation and management of patients to prescribe HIV PrEP/PEP described as an “office or other outpatient visit” and the administration of the medication. The CPT codes associated with the billing of these services include:

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 Prevention's 2021 Clinical Practice Guideline for PrEP.

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.

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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 following comments in response to the Proposed National Coverage Analysis (Proposed NCA) above, published in the Federal Register by the Centers for Medicare & Medicaid Services (CMS or the Agency) on July 12, 2023. J&J is the world’s most comprehensive and broadly-based manufacturer of healthcare products for pharmaceutical, medical devices, and diagnostics markets. For nearly 130 years, we have led the way in innovation and are continuing this heritage today by bringing important new pharmaceutical products and MedTech innovations to market in a range of therapeutic areas on behalf of all our current and future patients, including Medicare, Medicaid, and Marketplace beneficiaries. J&J is committed to ending the Human Immunodeficiency Virus (HIV) epidemic in the United States. As such, we support CMS’s recommendations in the Proposed NCA, including expanded coverage of Pre-Exposure Prophylaxis (PrEP) using effective antiretroviral therapy (ART), seven clinical visits every 12 months, and seven screenings every 12 months to prevent and detect HIV infections.

A. PrEP Using ART

PrEP using ART is highly effective for preventing HIV when taken as prescribed. More than a decade after PrEP medications first became available in the United States, many people who need PrEP cannot access it. Poor access is driven by expensive laboratory tests, excessive requirements for free services, and limited availability in many parts of the country. The disparities based on race, ethnicity, gender, sex and sexual orientation, and geography are profound. J&J supports the Proposed NCA, following the United States Preventive Services Task Force (USPSTF) recommendation to offer PrEP with effective ART to persons at high risk of HIV acquisition, with a Grade A rating. We share CMS’s health equity goals and support the implementation of measures across CMS programs aimed at improving health equity in coverage of all FDA-approved therapies to treat HIV.

B. Counseling Visits and Screenings

We also support CMS’s proposal to cover 1) up to seven individual counseling visits every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction, and medication adherence; and 2) HIV screening up to seven times annually for individuals being assessed for or who are taking PrEP using ART to prevent HIV infection. The PrEP care continuum includes medication and elements to improve awareness of HIV, uptake of treatment, adherence to the treatment plan, and retention. Counseling and screening are part of this clinical care model. Moreover, according to the Centers for Disease Control and Prevention (CDC), one in eight people living with HIV are unaware that have the virus, and despite seeing a primary care provider, approximately 75 percent of people at ongoing risk for HIV do not receive testing each year. About 40 percent of new HIV infections are transmitted by people whose HIV is undiagnosed and who are unaware they have HIV. Quickly diagnosing HIV and rapid treatment initiation is crucial to reducing new HIV infections. Appropriate coverage of individual counseling visits and screenings can help to achieve these goals.

Johnson & Johnson appreciates the opportunity to submit comments in response to the Proposed NCA. Please feel free to contact the J&J Payment and Delivery Team if there is any further information we can provide or if the Agency has additional questions about the topics discussed in our comments.

Jacqueline Roche, DrPH
Head Payment and Delivery Policy & Global Policy Institute
Johnson & Johnson Worldwide Government Affairs & Policy

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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 outcomes with medications that have proven useful in preventing disease in those who may be exposed to HIV.

CSHP is one of the largest associations in California, representing thousands of pharmacists and other pharmacy professionals. Our members practice in every sector of healthcare: hospitals, clinics, community pharmacies, ambulatory care, long-term care, public health, compounding pharmacies, academia, research, health maintenance organizations, and government.

Pharmacists are frontline healthcare providers providing care to their communities including access to PrEP and PEP regimens. In California, for example, pharmacists are explicitly authorized to independently prescribe and initiate PrEP and PEP. Pharmacists are the most highly accessible health care professionals in the community and their involvement in medication counseling, adherence, and risk reduction strategies further enhance the effectiveness of HIV preventive measures.

We commend CMS’s proposal to financially cover PrEP and the individual counseling visits. These counseling sessions play a pivotal role in ensuring proper utilization of PrEP and in reducing HIV transmission rates among vulnerable populations. However, we have a concern regarding the potential lack of reimbursement for the essential services if they are provided by pharmacists. We urge you to consider explicitly including the term "pharmacist" in the text, clarifying their authorization to determine PrEP initiation and to provide counseling. It is crucial to recognize that pharmacists are already authorized to deliver these services in California (and many other states), and this inclusion aligns with their scope of practice. The following page contains the proposed language from Appendix B, with the amendment we are requesting.

In conclusion, the CMS Decision Memo on PrEP marks a significant commitment in curbing the national spread of HIV. The active involvement of pharmacists is integral to its successful implementation. By specifically including pharmacists in the text, we ensure their rightful reimbursement for the vital services they provide, thereby strengthening collective efforts to combat HIV and enhance the health and well-being of our communities.

If you have any further questions or would like additional information, please do not hesitate to contact me at 916-447-1033 or via email at LDemartini@cshp.org.

Thank you for your time and consideration
Sincerely,

Loriann De Martini, PharmD, BCGP, MPH
Chief Executive Officer

APPENDIX B
Medicare National Coverage Determinations Manual

Draft

We are seeking public comments on the proposed language that we would include in the Medicare National Coverage Determinations Manual. This proposed language does not reflect public comments that will be received on the proposed decision memorandum, and which may be revised in response to those comments.
Table of Contents
(Rev.)
NCD 210.15 – Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Infection Prevention

A. General
Human immunodeficiency virus (HIV) continues to be a serious public health issue, with an estimated 1.2 million people aged 13 and older living with HIV in the United States. Due to continuing medical advances and earlier initiation and expanded access to medications, HIV is now considered a chronic condition rather than a terminal illness. Antiretroviral therapy (ART) is known to reduce HIV-related morbidity and mortality. Nearly half of the people in the United States diagnosed with HIV are aged 50 and older. Pre-exposure prophylaxis (PrEP) involves the use of ART on an ongoing basis (e.g., daily or bimonthly) or before and after HIV exposure events (“on-demand” or “event-driven” PrEP) to decrease the risk of acquiring HIV infection. When taken as prescribed, PrEP is highly effective for preventing HIV. PrEP can be an oral medication or an injection. Under §1861(ddd)(1) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of “additional preventive services” through the Medicare national coverage determination (NCD) process if certain statutory requirements are met: (1) reasonable and necessary for the prevention or early detection of illness or disability, (2) recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF), and (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

B. Nationally Covered Indications
Effective for claims with dates of service on or after xx/xx/xx, CMS proposes that the evidence is adequate to conclude that the United States Preventive Services Task Force (USPSTF) recommends offering Pre-Exposure Prophylaxis (PrEP) with effective antiretroviral therapy (ART) to persons at high risk of Human Immunodeficiency Virus (HIV) acquisition with a grade of A recommendation, is reasonable and necessary for the prevention or early detection of illness or disability under §1861(ddd)(1) of the Social Security Act (the Act), and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B.
CMS proposes to cover PrEP using antiretroviral drugs (whether oral or injectable) approved by the US Food and Drug Administration (FDA) to prevent HIV infection in individuals at high risk of HIV acquisition. The determination of whether an individual is at high risk for HIV infection is made by the physician, pharmacist, or health care practitioner who assesses the individual’s history. In addition, CMS proposes to also cover the administration of injectable PrEP using antiretroviral drugs to prevent HIV infection.
CMS also proposes to cover up to seven individual counseling visits, every 12 months, that include HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence. Counseling must be furnished by a physician, pharmacist, or other health care practitioner and individuals must be competent and alert at the time that counseling is provided.
Additionally, for individuals being assessed for or who are taking PrEP using ART to prevent HIV infection, CMS proposes to cover HIV screening up to seven times annually and a single screening for hepatitis B virus (HBV). These screening tests are proposed to be covered with the appropriate FDA approved laboratory tests and point of care tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations.

C. Nationally Non-Covered Indications
Preventive services are non-covered by Medicare unless specifically covered in this NCD, any other NCD or in statute or regulations.

D. Other
Medicare Part B coinsurance and deductible are waived for this preventive

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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 twice-yearly option would really revolutionize our repertoire! Medicare A, B and D, Medicaid and all Commercial insurance plans need to clearly cover the whole kit & caboodle for STI/blood-borne prevention and treatment, whether in the office, on a mobile health van, in an informal community out reach setting (how many people get HIV/Hep C/Hep B/Hep A since they can't or won't come to a clinic?) or at home, including all STI/blood-borne testing AND HIV viral load tests AND all vaccines which prevent STI/blood-borne disease.

"Lenacapavir is an investigational antiretroviral drug that is being studied as a potential PrEP product. One key difference from injectable cabotegravir for PrEP (CAB for PrEP), injectable lencapavir (injectable LEN) is being studied as a subcutaneous injection making it eligible for self-injection. In contrast, CAB for PrEP is an intermuscular injection in the buttocks and requires privacy. Two Phase III trials are underway, conducted by Gilead, to determine the efficacy of lenacapavir as a six-month injection."
PrEPWatch
Lenacapavir: Drug information. Dosing: Kidney Impairment: Adult (Lenacapavir)
CrCl =15 mL/minute: No dosage adjustment necessary. UpToDate

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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: 37105645.

We need coverage of all methods of pre-exposure prophylaxis (PrEP), as well as adequate reimbursement for injectable PrEP depending on if this is covered as a medical or pharmaceutical benefit. This should be standardized, as this medication is not cheap and we need to make this process easy for patients and not a lot of work to perform the coverage determination and prior auth for this medication and future similar medications.
David P Serota and others, Beyond the Biomedical: Preexposure Prophylaxis Failures in a Cohort of Young Black Men Who Have Sex With Men in Atlanta, Georgia, Clinical Infectious Diseases, Volume 67, Issue 6, 15 September 2018, Pages 965–970, https://doi.org/10.1093/cid/ciy297

Our clinic has poured many hours into developing workflows and processes around these medications and making them easy to access, yet we still face system barriers by payers. This is a preventative measure and barriers to obtain these medications should be as low as they are for other preventative measures like flu shots and mammograms (which are not even USPSTF grade A recommendations).

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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 assessments as outlined in the Centers for Disease Control and Prevention's 2021 Clinical Practice Guideline for PrEP.

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.

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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 this up PLEASE!!!

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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 (https://www.cdc.gov/endhiv/about-ehe/pillars.html) and National HIV/AIDS Strategy (2022-2025) which calls for additional focus on aging populations with HIV (https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/"). While CMS' discussion focuses mostly on older adults, persons with disabilities covered by Medicare or dually-eligible for Medicaid coverage also may be at increased risk of acquiring HIV (see e.g., Doyle KE, Sionean C, Paz-Bailey G, Hollis ND, Kanny D, Wejnert C; NHBS Study Group. High prevalence of disability and HIV risk among low socioeconomic status urban adults, 17 U.S. cities. Disabil Health J. 2020 Jan;13(1):100834; https://www.kff.org/hivaids/issue-brief/medicare-and-people-with-hiv/").

B. PrEP can support linkages to care for those with behavioral health conditions: As CMS alludes to, many older Americans with HIV have behavioral health conditions (see e.g., Deren S, Cortes T, Dickson VV, Guilamo-Ramos V, Han BH, Karpiak S, Naegle M, Ompad DC, Wu B. Substance Use Among Older People Living With HIV: Challenges for Health Care Providers. Front Public Health. 2019 Apr 24;7:94). PrEP is an opportunity to engage these patients in care. Persons with physical and cognitive disabilities also are at increased risk for mental health conditions and substance use disorders (see e.g., https://www.cdc.gov/ncbddd/disabilityandhealth/features/mental-health-for-all.html). PrEP can help link patients with disabilities and mental health conditions to additional care (Ikeda DJ, Kidia K, Agins BD, Haberer JE, Tsai AC. Roll-out of HIV pre-exposure prophylaxis: a gateway to mental health promotion. BMJ Glob Health. 2021 Dec;6(12):e007212. doi: 10.1136/bmjgh-2021-007212; https://store.samhsa.gov/product/Prevention-and-Treatment-of-HIV-Among-People-Living-with-Substance-Use-and-or-Mental-Disorders/PEP20-06-03-001; https://nida.nih.gov/publications/research-reports/common-comorbidities-substance-use-disorders/part-3-connection-between-substance-use-disorders-hiv).

C. Insurance including lack of Medicare coverage can be a barrier to receiving PrEP when needed (see e.g., Karishma Srikanth, Amy Killelea, Andrew Strumpf, Edwin Corbin-Gutierrez, Tim Horn, Kathleen A. McManus, “Associated Costs Are a Barrier to HIV Preexposure Prophylaxis Access in the United States”, American Journal of Public Health 112, no. 6 (June 1, 2022): pp. 834-838. Emma Sophia Kay, Rogério M. Pinto, “Is Insurance a Barrier to HIV Preexposure Prophylaxis? Clarifying the Issue”, American Journal of Public Health 110, no. 1 (January 1, 2020): pp. 61-64; https://www.clinicaladvisor.com/home/topics/hiv-aids-information-center/medicare-coverage-updates-hiv/"; Tseng C, Dudley RA, Chen R, Walensky RP. Medicare Part D and Cost-Sharing for Antiretroviral Therapy and Preexposure Prophylaxis. JAMA Netw Open. 2020;3(4):e202739. doi:10.1001/jamanetworkopen.2020.2739; Myers JE. Cost-Sharing Under Medicare Part D: Paying Dearly to End the HIV Epidemic? . JAMA Netw Open. 2020;3(4):e202835. doi:10.1001/jamanetworkopen.2020.2835 C. In addition to PrEP, Medicare ideally would cover post-exposure prophylaxis (PEP) for older adults at risk (https://www.hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/post-exposure-prophylaxis/").

Thank you for consideration of these comments. Sincerely, Mitchell Berger (submitted in personal capacity)

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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 example. Every other payer covers these products on the pharmacy benefit. But Medicare requires patients to jump through hoops to find a Part B DME supplier. Similarly, nebulizer solutions. Like diabetic supplies, neb solutions have a National Drug Code number and can be billed on the pharmacy benefit of every other payer.

This also creates situations of poly-pharmacy and patient confusion. Pharmacists want to take care of all the needs of their patients, but often cannot afford the infrastructure it takes to run a full-fledged and compliant Part B operation. Not to mention the need for costly Accreditation do do so, and the creation of an in-house compliance team to ensure regulatory compliance.

PLEASE, simplify our system by allowing Medicare Part D plans to cover diabetic testing supplies, all vaccines, and PrEP should this proposal pass. Our bifurcated system of payment does more harm than good for one most vulnerable populations. Thank you.

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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 requiring life long HIV treatment and other associated co-morbidities.

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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 coverage for all approved PrEP medications— oral and injectable. I have seen firsthand what untreated HIV disease can do to a person. Being infected and not knowing it. Becoming ill and seeking treatment. Being so ill that placing them on a ventilator for support is the only option to try and save this life. The cost of these lifesaving measures is immense and likely could have been avoided if PrEP had been available and affordable. I urge you to include all PrEP medication options for all Medicare recipients through all insurance plans/options available.

Thank you for the opportunity to comment.

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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 hand-in-hand and we are seeing high rates of new STI diagnoses across the country, so it is imperative that this is included in coverage. This is currently limited coverage by CMS and should not be.

Overall, I support this proposal with modifications.

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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 preventative healthcare to help clients/patients to take proactive steps to avoid a chronic or life-altering illness like HIV that will ultimately cost insurance payors more money in the long-term, so why not provide an opportunity to make a preventive service more accessible and cheaper to cover comparatively?

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