A HIV Drug Medicare Carveout Exemption is NOT All About the Profits

By: Marcus J. Hopkins, ADAP 340B Consultant

In July 2025, ADAP Advocacy submitted public comment to the Centers for Medicare and Medicaid Services (CMS) regarding the proposed guidance for the Medicare Drug Price Negotiation Program (“Negotiation Program”) established under the Inflation Reduction Act (2022), requesting a carveout exemption from forced price negotiations for medications used for the treatment of HIV.

Photo Source: ADAP Advocacy

After submitting this public comment, we took the opportunity to reach out to other HIV organizations, including the Aging and HIV Institute (A&H)’s David “Jax” Kelly, JD, MPH, MBA.

Kelly raised several key points that he believes would better center our arguments around patient access, medication affordability, and the elimination of barriers to accessing medications. These points, he told us, would help to reframe our argument to make it more patient-centered and less about pharmaceutical company participation in the Medicare market and profitability.

He was, in part, correct.

ADAP Advocacy is, at its heart, a patient-centered organization. From the beginning, our organization has prioritized patient access to HIV care, treatment, and supportive services. Our initial focus dealt with eliminating the waitlists that prevented patients in dire need of HIV treatment services from enrolling in state AIDS Drug Assistance Programs (ADAPs). Every aspect of our work has been patient-centered, and we have endeavored to frame every project, initiative, research effort, report, and infographic in a manner that prioritizes what is best for patients.

Our submission to CMS attempted to frame pharmaceutical company participation as a broader issue that could prevent patients from accessing their life-saving medications. We contend our framing achieved that objective, but nonetheless, we're open to alternative interpretations. After all, one of our organization's value statements reads, "That the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion."

With that in mind, ADAP Advocacy asked Kelly for his thoughts on the carveout. In his response, Kelly provided the following insights:

[The following comments were composed by David “Jax” Kelly, JD, MPH, MBA]

David "Jax" Kelly, JD, MPH, MBA

_____________________________________________

Medicare and HIV: A Lifeline for Long-Term Survivors

Nearly 28% of PLWH in the United States are Medicare beneficiaries, and most qualified through disability rather than age (Figueroa et al., 2024; Dawson, 2023). For this population, Medicare Part D is a lifeline, yet HIV medications account for a disproportionate share of program spending. In 2020, prescription drugs made up 63% of Medicare spending for PLWH compared to just 4% for other beneficiaries (Dawson, 2023).

This unique cost profile reflects both the effectiveness and the financial burden of HIV treatment. Interruptions in ART jeopardize not only individual health but also public health goals. Sustained viral suppression—essential to ending the epidemic—depends on reliable, affordable access to medications.

Moreover, a majority (61%) of Medicare beneficiaries with HIV are dually eligible for Medicaid, highlighting their financial and medical vulnerability (Dawson, 2023). These dual-eligible beneficiaries face some of the most complex systemic barriers and are at greatest risk if policy shifts raise out-of-pocket burdens.

Patient Affordability and Financial Burden

Even when medications are technically “covered,” high co-pays and cost-sharing can prevent patients from filling prescriptions. Research shows persistent gaps in ART adherence among Medicare beneficiaries with HIV, often tied to affordability barriers (Li et al., 2023).

The Inflation Reduction Act reshaped Medicare Part D plan designs, and analyses show that some changes may actually increase cost burdens for patients depending on their plan type (Cai et al., 2025; Doshi et al., 2025).

Consider a hypothetical example:

For a retired Medicare beneficiary living on $1,400 a month, an additional $100 in monthly drug costs could force a choice between filling an HIV prescription and paying for groceries or rent. For long-term survivors already managing multiple chronic conditions, even modest increases in out-of-pocket (OOP) costs can destabilize adherence and jeopardize viral suppression.

Drug coverage protections exist—ART is already a “protected class” under Part D—but these safeguards do not directly limit cost-sharing. Without a carveout, federal savings from negotiation could inadvertently be achieved at the expense of patient affordability and adherence.

Equity and Systemic Barriers

Medicare beneficiaries with HIV are disproportionately people of color, LGBTQ+ individuals, and long-term survivors. According to KFF, most (77%) qualified for Medicare through disability rather than age, and a majority (61%) are dually eligible for Medicaid (KFF, 2025). These data underscore the extent of financial and medical vulnerability within this population—reflecting the compounding effects of poverty, disability, and structural inequities.

The burden of prescription drug costs falls especially hard on people with HIV. While prescription drugs account for just 4% of Medicare spending among other beneficiaries, they represent 63% of Medicare spending for people with HIV (Dawson, 2023). This disproportionate reliance on costly medications makes beneficiaries uniquely exposed to policy changes that could shift costs onto patients.

Photo Source: HealthHIV

The most recent State of Aging with HIV Report adds further context. Nearly 80% of older adults living with HIV delayed or avoided care due to insurance or out-of-pocket costs, and almost half struggled to pay for housing, food, or utilities (HealthHIV, 2025). Insurance restrictions such as step therapy and prior authorizations are increasingly blocking or delaying access to needed HIV medications. At the same time, many report fragmented care: over one-third rely on emergency departments for non-urgent needs, while 63% lack access to case management services (HealthHIV, 2025).

These inequities extend beyond finances. Nearly half of older adults with HIV report feeling lonely or isolated, and more than three-quarters experience moderate to high levels of mental health stress (HealthHIV, 2025). Meanwhile, providers highlight systemic barriers as well: 59% cite shortages of clinicians trained in both HIV and geriatrics as the most pressing obstacle to appropriate care.

Equity in drug policy is not just a matter of fairness; it is central to survival. The National HIV/AIDS Strategy emphasizes reducing disparities in HIV outcomes for racial and ethnic minorities, LGBTQ+ communities, and older adults. If CMS drug price negotiations inadvertently increase barriers to HIV treatment, they risk undermining these national goals at a time when they are already under political attack.

Protecting affordability and uninterrupted access through a carveout would ensure that Medicare policy advances—rather than reverses—the nation’s commitment to equity in HIV care and outcomes.

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Kelly’s comments offer additional clarity and justification in favor of a carveout exemption in a way that focuses less on the continued participation of pharmaceutical companies and more on the real-world needs of patients who rely upon the Medicare program.

One of the primary reasons we work with collaborative partners and organizations is to ensure that the work we’re doing is focused on meeting the needs of patients. ADAP Advocacy specifically works with other organizations and policy shops to inform, refine, and bring clarity to the positions we release.

We are incredibly grateful to Jax Kelly for helping us to fulfill that mission.

References:

Cai, C. L., Bhaskar, A., Kesselheim, A. S., & Rome, B. N. (2025). Changes in Medicare Part D plan designs after the Inflation Reduction Act. JAMA Internal Medicine. Advance online publication. https://doi.org/10.1001/jamainternmed.2025.4003

Dawson, L., Kates, J., Roberts, T., Cubanski, J., Neuman, T., & Damico, A. (2023). Medicare and people with HIV. San Francisco, CA: KFF. https://www.kff.org/hivaids/report/medicare-and-people-with-hiv/

Dickson, S., & Hernandez, I. (2023). Drugs likely subject to Medicare negotiation, 2026–2028. Journal of Managed Care & Specialty Pharmacy, 29(7), 732–739. https://doi.org/10.18553/jmcp.2023.29.3.229

Doshi, J. A., Li, P., Harrison, J., Romley, J., & McWilliams, J. M. (2025). Inflation Reduction Act provisions and Medicare Part D out-of-pocket costs for specialty drugs. JAMA Health Forum, 6(8), e233849. https://doi.org/10.1001/jamahealthforum.2025.1387

Figueroa, J. F., et al. (2024). Antiretroviral therapy use and disparities among Medicare beneficiaries with HIV. Journal of General Internal Medicine, 39(12), 3456–3464. https://doi.org/10.1007/s11606-024-08847-y

Figueroa, J. F., et al. (2025). Use of nonrecommended antivirals among Medicare beneficiaries with HIV. JAMA Network Open, 8(7), e2312345. https://doi.org/10.1001/jamanetworkopen.2025.8296

HealthHIV. (2025). The fourth state of aging with HIV national survey report. Washington, DC: HealthHIV. https://healthhiv.org/wp-content/uploads/2025/01/Fourth-HealthHIV-State-of-Aging-with-HIV-Report.pdf

Kakani, P., Kyle, M. A., Chandra, A., & Maini, L. (2024). Medicare Part D protected-class policy is associated with lower drug rebates. Health Affairs, 43(8), 1290–1298. https://doi.org/10.1377/hlthaff.2024.00273

Li, P., et al. (2023). Antiretroviral treatment gaps and adherence among people with HIV in Medicare. Journal of Acquired Immune Deficiency Syndromes, 92(2), 145–152. https://doi.org/10.1007/s10461-023-04208-8

Patterson, J. A., et al. (2024). Medicare Part D coverage of drugs selected for the Drug Price Negotiation Program. JAMA Health Forum, 5(2), e234562. https://doi.org/10.1001/jamahealthforum.2023.5237

Sadeghi, A., & Varisco, T. J. (2025). Medicare Drug Price Negotiation Under The Inflation Reduction Act: Ensuring the Continuity of Critical Real-world Pharmaceutical Studies. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, S1098-3015(25)02466-0. https://doi.org/10.1016/j.jval.2024.12.012

White, E. N., Saxon, M., Hodge, J. G., Jr, & Michaels, J. (2023). Medicare Drug Pricing Negotiations: Assessing Constitutional Structural Limits. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 51(4), 956–960. https://doi.org/10.1017/jme.2024.12 

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.     

Older Adults, Long-term Survivors, and Life-term Survivors in the Ryan White HIV/AIDS Program

By: Ranier Simons, ADAP Blog Guest Contributor

The lived experience of aging can be challenging. Those aging while living with HIV experience additional challenges as compared to the general population. According to the Centers for Disease Control & Prevention (CDC), in 2021, over 53 percent of people living with HIV/AIDS (PLWHA) were 50 years old or older.[1] In 2022, 48.2 percent of the 560,000 clients served by the Ryan White HIV/AIDS Program (RWHAP) were aged 50 or older.[2] As such, Health Resources & Services Administration (HRSA) recently issued a letter to RWHAP colleagues to not only bring awareness of the aging issues they should be addressing but also provide guidance and resources to help them more effectively serve the complex needs of aging PLWHA.

Photo Source: TargetHIV

As David “Jax” Kelly, President of Let’s Kick ASS (AIDS Survivor Syndrome) Palm Springs and Founder & CEO of the Aging and HIV Institute, points out, “The community aging with HIV consists of two distinct groups long-term survivors who have been living with HIV prior to 1995, and those who are over 50 and have been living with HIV after the discovery of the "cocktail" – antiretroviral medications that changed HIV/AIDS to a chronic condition rather than a diagnosis of imminent death.” According to Kelly, this aging cohort has specific medical, psychosocial, and support needs. The fact that more PLWHA are living longer increases the urgency of bolstering the infrastructure of HIV aging services.

Just like the general population, aging PLWHA experience age-related medical issues. However, older PLWHA have a higher prevalence of non-HIV comorbidities.[3] Thus, managing multiple morbidities and polypharmacy is a challenge.[3] Numerous medical issues mean treatment with multiple medications. The difficulty of navigating the medical aspects of multiple maladies is compounded by having to monitor drug-drug interactions of non-HIV-related medications with antiretroviral therapies. In addition to prescription drugs, older PLWHA may be taking over-the-counter medicines like pain relievers and supplements.[4] Studies also show that PLWHA develop age-related non-HIV medical issues earlier than the aging general population.[5] Some of the non-HIV-related conditions with higher prevalence among PLWHA are hypertension, kidney disease, dyslipidemia, and anemia.[5] One of the possible causes of higher rates of comorbidities is the side effects of long-term ART experienced by long-term survivors. 

Aging PLWHA also have specific psychosocial needs. According to Kelly, “Long-term survivors who experienced the trauma of the AIDS plague years when life expectancy was sometimes merely a few months are experiencing another wave of loss that may trigger survivor's guilt.” Social isolation is also an issue.[6] It is a challenge for the general population, but it can be extra challenging for PLWHA; especially those who may be LGBTQ. Aging PLWHA who happen to be LGBTQ have sometimes lost friends and people they consider chosen families. Due to ageism, sexism, racism, and homophobia, they live in self-isolation and are isolated, given that society does not place any priorities on ensuring their comfortable existence. 

Depression from physical and social isolation is not the only serious mental challenge aging PLWHA struggle with. Aging, in general, can sometimes bring on a bit of mental decline. However, cognitive impairment due to HIV-associated neurocognitive disorder (HAND) is also a known complication of HIV.[7] HAND can cause difficulty with concentration and memory, irritability, and motor skills issues.[7] In late, untreated stages, it can cause dementia. Psychosocial challenges and mental decline not only result in poor mental health but are barriers to maintaining medication adherence or achieving a high level of personal care.

Support is an area where much improvement is needed. The aging PLWHA population is diverse. People in their 50s, 60s, 70s, and up have different and dynamic needs. HIV care and geriatric care are siloed and not well coordinated. A technical expert panel put together by HRSA reported that in the U.S., primary care practitioners are not skilled in geriatric care, and geriatric practitioners are not skilled in HIV care.[8] It is imperative to have coordinated care efforts that are efficient, effective, and sustainable to encompass all the needs of aging PLWHA. 

Photo Source: HRSA | Flickr

Additionally, there are shortages of geriatricians, and many primary care practitioners don’t have the time to adequately address the needs of and perform the screenings needed for aging PLWHA.[8] HIV stigma and ageism, unfortunately, exist in the medical environment as well. Many clinicians, especially younger professionals, underestimate the mental and cognitive abilities of older PLWHA and don’t view them as sexual beings. Lacking knowledge and training of what it means to age with HIV results in not performing necessary medical screenings, overlooking thorough holistic needs assessments, and even inadequate tracking of health outcomes.

HRSA understands the interdisciplinary, multifaceted approach needed to effectively serve aging PLWHA. That is why the “Dear Colleague” letter was written. The letter references many tools and knowledge sources for RWHAP recipients to utilize. 

First and foremost, the letter reminds them that it is acceptable to use RWHAP funds to support aging PLWHA across various HRSA RWHAP core medical and support service categories.[2] However, HRSA is aware that there are some needs aging PLWHA have that RWHAP funds cannot directly address. For example, long-term care is not an allowable expense through RWHAP. To that end, HRSA refers RWHAP colleagues to connect with the Administration for Community Living’s (ACL) aging network grantees.[2] These community centers offer many services to help address holistic needs, such as transportation, housing, caregiver support, insurance counseling, and nutrition services.[2]

HRSA also provides reference and training materials to inform RWHAP recipients on ways to improve service delivery and structure their organizations. These are available through TargetHIV.org and the RWHAP AIDS Education and Training Center (AETC) Program’s National Coordinating Resource Center website.[2] A couple of these reference guides are: ‘Incorporating New Elements of Care’ and ‘Putting Together the Best Healthcare Team.’ Those two guides help identify screen assessments, screenings, and social needs of aging PLWHA, as well as guidance on how to effectively staff teams and build capacity.[9]

HRSA’s commitment to support the RWHAP is truly beneficial to the success of the programming. Tez Anderson, President & Founder, Let’s Kick ASS (AIDS Survivor Syndrome), expressed these sentiments regarding HRSA’s efforts: “As an advocate and someone living with HIV for over 40 years, I’m pleased HRSA is shining a light on the Ryan White Cares services available for the large and diverse cohort of older adults living with HIV and long-term survivors. As a group, we all have unique needs, and the priority must be to improve our quality of life. For those of us who have lived over half our lives with HIV, we agree living longer is a fantastic achievement, but living better is where hope lives.”

[1] NIH Office of AIDS Research. (2024, March 12). HIV and Older People. Retrieved from https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-and-older-people

[2] Cheever, L. (2024, August 16). Dear Colleague Letter on Older Adults, Long-term Survivors, and Life-term Survivors in the Ryan White HIV/AIDS Program. Retrieved from https://paetc.org/resources/dear-colleague-letter-on-older-adults-long-term-survivors-and-life-term-survivors-in-the-ryan-white-hiv-aids-program/

[3] Kong, A. M., Pozen, A., Anastos, K., Kelvin, E. A., & Nash, D. (2019). Non-HIV Comorbid Conditions and Polypharmacy Among People Living with HIV Age 65 or Older Compared with HIV-Negative Individuals Aged 65 or Older in the United States: A Retrospective Claims-Based Analysis. AIDS patient care and STDs, 33(3), 93–103. https://doi.org/10.1089/apc.2018.0190

[4] NIH Office of AIDS Research. (2019, December 18). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. Retrieved from https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/special-populations-hiv-and-older

[5] Schouten, J., Wit, F. W., Stolte, I. G., Kootstra, N. A., van der Valk, M., Geerlings, S. E., Prins, M., Reiss, P., & AGEhIV Cohort Study Group (2014). Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America, 59(12), 1787–1797. https://doi.org/10.1093/cid/ciu701

[6] HRSA. (n.d.) Optimizing HIV Care for People Aging with HIV:  Incorporating New Elements of Care Reference Guide for Aging with HIV. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/aging-guide-new-elements.pdf

[7] Eggers, C., Arendt, G., Hahn, K., Husstedt, I. W., Maschke, M., Neuen-Jacob, E., Obermann, M., Rosenkranz, T., Schielke, E., Straube, E., & German Association of Neuro-AIDS und Neuro-Infectiology (DGNANI) (2017). HIV-1-associated neurocognitive disorder: epidemiology, pathogenesis, diagnosis, and treatment. Journal of Neurology, 264(8), 1715–1727. https://doi.org/10.1007/s00415-017-8503-2

[8] HRSA. (n.d.). Addressing the Health Care and Social Support Needs of People Aging with HIV: Technical Expert Panel Executive Summary. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/resources/hrsa-aging-tep-summary.pdf

[9] HRSA. (2022, February). Clinical Care Guidelines and Resources. Retrieved from https://ryanwhite.hrsa.gov/grants/clinical-care-guidelines-resources

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.