HIV Clusters Spread, as Republicans Seek Deep Cuts to HIV Funding

By: Ranier Simons, ADAP Blog Guest Contributor

In the current political climate, given the government’s health policy landscape, many stakeholders are concerned about the stability of public health. This is undeniably true in the HIV space. Republicans seek deep cuts to HIV prevention and treatment funding, which would destabilize the already tenuous nature of care for people living with HIV/AIDS (PLWHA), especially those in vulnerable populations. Hindering effective HIV response is disconcerting, with trends such as HIV clusters appearing. In recent times, HIV cluster outbreaks have been identified. Fruitful public health support of PLWHA requires an increase in resources, not a reduction.

Photo Source: Maine.gov

One such cluster of increased HIV transmission is in Penobscot County, Maine, where Bangor is located. A cluster outbreak was first identified there in late 2023 (Budlon, 2025). A cluster is a group of people with related HIV infections. As of September 2025, the number of cases in this cluster has reached 29 (main DHHS). This area of Maine typically sees only two instances of transmission per year (Budlon, 2025). The majority of those involved in this cluster have been experiencing homelessness, injection drug use, or both in the 12 months before their diagnosis (Tusinksi, 2025). These conditions do not cause HIV; however, they do increase the risk of transmission. Housing instability hinders treatment adherence and consistent access to HIV care. Injection drug use can lead to behavior with increased risk, including sharing needles (Arum et al., 2021). Public health officials infer that the number of transmissions is likely higher than 29, given that many have not been tested.

Another cluster seeing a notable increase is in New York. The increase in infections in a reported cluster in Broome County, New York, in early August is higher than the number seen annually over the past four years. Most of those in the cluster are unhoused, have used intravenous drugs, are Caucasian, and between the ages of 30 and 45 (McCarthy, 2025). In addition to those identified in the clusters, the Broome County Health Department estimates there are a couple of dozen more people who have been exposed to HIV that they are not aware of (McCarthy, 2025). Additionally, as of 2023, Broome County has the third-highest rate of new Hepatitis C mortality in New York state (McCarthy, 2025). Hepatitis C, tuberculosis, Hepatitis B, and syphilis are often comorbid with HIV (McCarthy, 2025). HIV transmission has historically been overrepresented in the South; thus, this Northeastern trend is concerning.

Actions by the current administration are in direct opposition to supporting the reversal of these transmission trends. Reductions in HIV-related funding are harmful on many levels. In a July 2025 Executive Order (EO), the President implies defunding harm reduction. Harm reduction includes syringe service programs (SSP) in which evidence-based data shows that they are one of the best ways to prevent HIV and Hepatitis spread among those who inject drugs. Unlike the EO states, SSPs or safe consumption sites do not facilitate or worsen drug use. Two prominent SSPs in Maine have already shut down. The Maine Center for Disease Control and Prevention revoked the Health Equity Alliance’s (HEAL) syringe exchange certification in January 2025 (Bush, 2025). Additionally, due to a zoning issue, SSP Needlepoint Sanctuary was forced to close in July 2025 (Rupertus, 2025).

The language of the EO also paints the unhoused as a criminal group riddled with drug addiction and mental health disease, deserving of involuntary commitment to facilities to restore public safety. The President’s prescription of rounding up people experiencing homelessness and destroying encampments is the same sentiment that resulted in Camp Hope being closed in February of this year. It was the largest homeless encampment in Bangor, Maine (Peters, 2025). Many of those pushed out of the encampment have not been connected to residential situations and remain unhoused. The encampment served as a means for public health providers to reach unhoused PLWHA for treatment and tracing. However, with the residents of the encampments now scattered, any linkage to care that had occurred is destroyed. That is detrimental to PLWHA and the public since HIV prevention is a public issue.

Photo Source: CNN

The House Republican budget proposal slashes federal HIV prevention and treatment funding, seeking almost $2 billion in HIV-related cuts (Ryan, 2025). This is coupled with the large number of HIV related NIH grants that have already been defunded. In a speech, NIH Director Dr. Jay Bhattacharya stated, “We have now in our capacity the ability to actually end the HIV epidemic by 2030, to reduce HIV transmission to very, very low levels. And we just need to figure out how to do it” (Ryan, 2025). It is unclear how this goal can be achieved, given the massive amount of HIV treatment and prevention defunding that the Trump Administration and House Republicans wish to achieve. 

Regardless of the current destabilization in the HIV-related public health space, monitoring for transmission trends and cluster outbreaks is imperative. A challenging aspect of monitoring is HIV molecular surveillance. HIV molecular surveillance involves the collection and tracking of virus sequences from specific genetic strains of HIV. HIV transmission reporting is required by law for public health purposes. When a person tests positive for HIV, additional genetic bloodwork is done to determine the specific strain of HIV for epidemiological and cluster tracking purposes. 

In theory, meaningful data analysis is achieved by collecting this information. However, there are no proper safeguards in place to ensure the privacy of the PLWHA from whom this data is collected. Privacy breaches could result in harm, including economic and physical safety concerns. There are safer means of acquiring tracking data, such as tracking HIV through comprehensive case surveillance, behavioral and clinical monitoring, and analysis of pharmaceutical data (CDC, 2025). ADAP Advocacy is strongly opposed to HIV molecular surveillance being used to combat HIV clusters and has routinely supported the Center for HIV Law and Policy in its advocacy in this space.

Photo Source: Center for HIV Law & Policy

Data shows that some HIV transmission statistics are trending in the wrong direction. Now is not the time to destabilize the fragile infrastructure that is the status quo. If massive defunding ultimately becomes a permanent reality, HIV clusters will increase, and many preventable transmissions will occur. That outcome will result in a significantly higher level of societal and governmental spending compared to the savings the administration professes to achieve from its proposed fiscal cuts.

[1] Arum, C., Fraser, H., Artenie, A. A., Bivegete, S., Trickey, A., Alary, M., Astemborski, J., Iversen, J., Lim, A. G., MacGregor, L., Morris, M., Ong, J. J., Platt, L., Sack-Davis, R., van Santen, D. K., Solomon, S. S., Sypsa, V., Valencia, J., Van Den Boom, W., Walker, J. G., … Homelessness, HIV, and HCV Review Collaborative Group (2021). Homelessness, unstable housing, and risk of HIV and hepatitis C virus acquisition among people who inject drugs: a systematic review and meta-analysis. The Lancet. Public health, 6(5), e309–e323. https://doi.org/10.1016/S2468-2667(21)00013-X. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC8097637

[2] Budlon, K. (2025, July 11). Penobscot County HIV outbreak continues to grow; providers say the rest of Maine is at risk. Retrieved from https://www.mainepublic.org/health/2025-07-11/penobscot-county-hiv-outbreak-continues-to-grow-providers-say-the-rest-of-maine-is-at-risk

[3] Bush, B. (2025, January). Maine CDC change to syringe-exchange program in Bangor displaces need for services. Retrieved from https://www.newscentermaine.com/article/news/health/health-equity-alliance-syringe-needle-exchange-program-revoked-maine-cdc/97-f5132e6d-2c9f-405c-b034-cae05cd6de1c

[4] Centers for Disease Control and Prevention. (2025, February 7).About HIV Surveillance and Monitoring. Retrieved from https://www.cdc.gov/hiv-data/about/index.html#:~:text=Medical%20Monitoring%20Project%20(MMP):,outlets%20in%20the%20United%20States. 

[5] McCarthy, J. (2025, September 17). HIV cases have increased in Broome County cluster. Why there is still a 'big unknown'? Retrieved from https://www.pressconnects.com/story/news/public-safety/2025/09/17/hiv-cases-rise-in-ny-cluster-while-health-leaders-grapple-with-containment/86181140007/

[6] Peters, D. (2025, February 28). 'It's family here': Bangor officially closes city's largest homeless encampment. Retrieved from https://www.newscentermaine.com/article/news/local/bangor/bangor-closes-homeless-encampment-camp-hope-maine/97-00f3028d-4739-4ce9-b5fc-9287ab30e6ff#:~:text=Boyd%20Kronholm%2C%20executive%20director%20of%20the%20Bangor,approach%2D%2Drather%20than%20an%20immediate%20sweep%2D%2Dis%20more%20effective.

[7] Rupertus, A. (2025, July 28). Bangor syringe exchange service shuts down shortly after opening. Retrieved from https://www.bangordailynews.com/2025/07/28/bangor/bangor-health/needlepoint-sanctuary-shut-down-shortly-after-opening-n6hjn1me0n/

[8] Ryan, B. (2025, September 29). Republicans seek deep cuts to HIV prevention and treatment funding. Retrieved from https://www.msn.com/en-us/news/other/republicans-seek-deep-cuts-to-hiv-prevention-and-treatment-funding/ar-AA1NGD63?ocid=socialshare

[9] Tusinski, D. (2025, July 23). How a ‘cluster’ of HIV cases in Penobscot County became one of Maine’s largest outbreaks. Retrieved from https://www.pressherald.com/2025/07/23/how-a-cluster-of-hiv-cases-in-penobscot-county-became-one-of-maines-largest-outbreaks/

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.    

Rural Health Transformation Program Offers Opportunity

By: Ranier Simons, ADAP Blog Guest Contributor

Budget reconciliation legislation, H.R. 1, also known as the "One Big Beautiful Bill Act," was signed into law in July of this year. The bill slashes overall Medicaid spending by $911 billion over ten years. This funding reduction would decrease Medicaid spending in rural areas by over $119 billion over the next ten years (Saunders, Burns, & Levinson, 2025). Medicaid covers one in four adults in rural areas, where 20% of the U.S. population resides. In response to the significant fiscal damage to rural areas resulting from H.R. 1, the bill includes a $50 billion fund known as the Rural Health Transformation Program (RHT). The $50 billion RHT is temporary, time-limited funding that does not remedy the over $119 million in cuts from H.R.1. However, it presents as an option to obtain a modicum of assistance to bolster rural programs.

Photo Source: CMS

To receive RHT funding, states must apply for a grant by submitting a Rural Health Transformation Plan. The RHT will distribute $10 billion annually from 2026 through 2030. Half of the funds will be distributed equally among the states that obtain approval of their transformation plans, and the remainder will be left to the discretion of CMS. The due date for applications is November 5, 2025, with a statutory deadline of December 31, 2025, for CMS to issue rewards (Howard et al., 2025). 

According to the Rural Health Transformation Program website, the program was created to “empower states to strengthen rural communities across America by improving healthcare access, quality, and outcomes by transforming the healthcare delivery ecosystem. In essence, the program is designed to stabilize and transform rural health systems nationwide by supporting infrastructure, workforce development, and innovative care delivery models. All comprehensive rural health transformation plans submitted with the funding application must include proposals that invest in at least three of the following areas (Karl et al.):

• Prevention and Chronic Disease: Implementing evidence-based, measurable interventions to improve prevention and chronic disease management. 
• Provider Payments: Supporting payments to providers for delivering healthcare services that fill a gap in care coverage (e.g., uncompensated care). 
• Consumer Technology Solutions: Expanding consumer-facing, technology-driven tools for chronic disease prevention and management.
• Training and Technical Assistance: Building capacity for adoption of technology-enabled solutions in rural hospitals. 
• Workforce: Recruiting and retaining clinicians in rural areas, with a minimum five-year service commitment. 
• IT Advances: Upgrading information technology at rural health facilities to improve efficiency and health outcomes. 
• Right-Sizing Care Availability: Helping rural communities align healthcare service lines (preventive, ambulatory, emergency, inpatient, post-acute) with community needs. 
• Behavioral Health: Expanding access to opioid-use disorder treatment, other substance-use disorder services, and mental healthcare. 
• Innovative Care Models: Supporting value-based care, alternative payment models, and other innovative delivery arrangements. 
• Capital Expenditures and Infrastructure: Investing in facility upgrades, minor renovations, and equipment to ensure sustainable operations. 
• Community Collaboration: Fostering partnerships between rural facilities and other providers to strengthen quality, financial stability, and access.

Photo Source: Shulkin Blog

Presently, numerous states are actively seeking public input on what projects and priorities they should consider in creating programs with which to utilize the funds they apply for. The following link indicates which states are presently receiving comments, as well as the official guidance on how to submit suggestions: Tracking State Preparation for the Rural Health Transformation Program. One state example is Louisiana, which created a landing page for its Request for Information (RFI). Notably, among the rural health challenges that need to be addressed, the Louisiana Department of Health directly highlighted HIV. The site specifies that 56% of new HIV cases are from outside of New Orleans and Baton Rouge. Georgia is another state that could benefit from funding for programs to address the needs of its rural population that is living with HIV. The results from a recently published paper indicate that significant disparities in HIV care access and support exist when comparing rural Georgians to those living in urban areas (Purcell et al., 2025).

As states create application proposals, it is imperative that they research all the fine details of what can and cannot be included. Prohibited uses of funds include support for new construction and building expansions, clinician salaries or wages at facilities with non-compete agreements, expenditures associated with financing the non-federal share of program costs, and requirements related to documenting citizenship (Karl et al., 2025). Given the current political climate, it is essential to navigate the application process with discernment while ensuring that a submitted plan aligns with all organizational goals.

As states submit plans, it would be very encouraging to see elements included that align with the Ending the HIV Epidemic (EHE) Initiative, increase capacity for HIV linkage to care in rural areas, and ways to improve rural PrEP access. Some rural hospitals have already closed, and the massive cuts in Medicaid spending threaten to close more. The RHT is a band-aid on a large wound that is more appropriate for stitches. However, in the status quo of rural healthcare, every dollar counts.

[1] Howard, H, Lopez, R., McLean, J, SHVS. (2025, September 18). Tracking State Preparation for the Rural Health Transformation Program. Retrieved from https://shvs.org/tracking-state-preparation-for-the-rural-health-transformation-program/

[2] Karl, A., Herring, A., Osius, L., Rains, J., Mannatt Health. (2025, September 17). CMS Releases Rural Health Transformation Funding Opportunity. Retrieved from https://shvs.org/wp-content/uploads/2025/09/CMS-Releases-Rural-Health-Transformation-Funding-Opportunity_SHVS.pdf

[3] Purcell, D. J., Standifer, M., Martin, E., Rivera, M., & Hopkins, J. (2025). Disparities in HIV Care: A Rural-Urban Analysis of Healthcare Access and Treatment Adherence in Georgia. Healthcare (Basel, Switzerland), 13(12), 1374. https://doi.org/10.3390/healthcare13121374

[4] Saunders, H., Burns, A., Levinson, Z. (2025, Jun 27). How Might the House-Passed Reconciliation Bill’s Medicaid Cuts Affect Rural Areas? Retrieved from https://www.kff.org/medicaid/how-might-the-reconciliation-bills-medicaid-cuts-affect-rural-areas/

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.   

When is 'Enough' Going to Be Enough for Hospital CEOs?

By: Marcus J. Hopkins, ADAP 340B Consultant

Did you know?

Almost all but two of the ten highest-paying professions in the United States are in the medical field. The two professions that are not inherently medical in nature are airline pilots and Chief Executives. On the U.S. News list of the top ten jobs, Chief Executive salaries rank 10th, with a median annual salary of $206,680 (U.S. News, 2025).

Photo Source: Lown Institute

Apparently, U.S. News hasn’t met very many hospital CEOs. In particular, CEOs running the hospitals raking in millions of dollars from the lucrative 340B Drug Pricing Program—which is designed to help poor patients.

Hospitals are vital services filled with people who literally save lives every day, and at the top of the pile sits the Chief Executive Officer, ostensibly responsible for ensuring their hospital can keep the lights on and the patients alive and well. It’s a critical job that requires expertise and understanding of not only the healthcare space, but of business, management, finance, and publicity.

Of the 63 hospitals that ADAP Advocacy has audited since 2023, not a single CEO earned a salary so little as $206,680. Instead, across all 63 hospitals, the average CEO compensation package was $3,378,461—just a bit higher than the figure on the U.S. News list.

Now, obviously, U.S. News’ report considers all CEO positions across all sectors, but it raises the question of whether U.S. News needs to adjust its methodology.

It’s no secret that CEO pay at hospitals has long outpaced the incomes of the people working in those hospitals—people who often work significantly more extended hours and hold in their hands the literal lives of other human beings. In fact, a 2023 report from the North Carolina State Health Plan for Teachers and State Employees found that the CEO pay of just 11 of North Carolina’s non-profit hospitals was the equivalent of what those same hospitals would pay to hire 572 nurses (North Carolina State Health Plan for Teachers and State Employees, 2023).

The NC State Health Plan report highlights just how severe those pay gaps are, particularly at a time when wage growth for non-physician roles is slowing due to hospital system consolidation (Prager & Schmitt, 2021). More damning was that, during the COVID-19 pandemic, hospital CEOs gladly accepted exponential pay raises at these hospitals. In contrast, hospital staff—the individuals responsible for saving lives—were instructed to make do with insufficient supplies and personal protective equipment (Shabad, 2020).

Photo Source: North Carolina State Health Plan for Teachers and State Employees

The issue with CEO compensation, in general, is that CEOs tend to demand high compensation packages, particularly for companies and organizations that generate billions of dollars in revenue annually, and boards of directors often feel compelled to accept those demands. If they don’t want to pay that much, the candidate can simply walk away and find it elsewhere.

The non-physician employees who provide the bulk of care in hospitals don’t have that luxury.

Imagine if nurses and other hospital support staff demanded starting salaries of just $100,000 a year. They would be laughed out of the room, their demands would be rejected, and they would be accused of putting money ahead of patients. In fact, it wasn’t until 1974 that non-profit hospitals were allowed to form labor unions (National Labor Relations Board, n.d.), and even then, they could only do so if they agreed not to strike. 

When nurses strike, as with teachers, the argument is made that they are being selfish for striking. The criticism reflects: How DARE they put the lives of patients at risk?! Never mind that there have been critical nursing shortages for most of the past decade, and that shortage is expected to get considerably worse by 2030 (University of St. Augustine for Health Sciences, 2024). These shortages are driven by several factors, including (but not limited to):

• A rapidly expanding aging population, which grew from 41 million people in 2011 to 71 million in 2019 (a 73% increase; Paavola, 2020)
• An aging Registered Nurse (RN) population that is starting to retire, with more than 25% of all RNs saying in 2022 that they would leave or retire from the field within five years (Rosseter, 2024)
• Nurses not being located where the shortages are greatest
• Job stress, fatigue, and burnout (University of St. Augustine for Health Sciences, 2024)

Meanwhile, the CEO HCA Healthcare—the largest health system in the United States—gladly accepted a compensation package totaling $23,799,137, while the median HCA employee earns $60,082 (Brusie, 2025). This new compensation package increases the HCA CEO-to-worker pay ratio from 356 to 1 in 2023 to a staggering 391 to 1.

Photo Source: Vecteezy

The reality is that, while hospital CEOs have important jobs, they should never have become the stars of the show. Unfortunately, there are no data available that can demonstrate whether or not revenues received from the 340B Drug Pricing Program—a program created to ensure that poor patients were able to access low-cost medications and healthcare services by reinvesting those revenues into increasing access and affordability for those patients—have been used to increase the compensation packages of CEOs or other executives.

We argue that 340B dollars, regardless of the covered entity eligible to receive them, should be directly tied to improving access and affordability for patients. One way to improve services, for example, would be to use those funds to hire more nurses. Or increase the pay of the existing nurses. Or keep rural hospitals open instead of closing them and consolidating them.

There are a lot of moving parts in this debate, but the reality is that we’ve allowed CEO pay at 340B-eligible hospitals to get entirely out of hand. And if we don’t get a handle on the problem, soon, the companies that foot the bill—pharmaceutical companies—are going to refuse to participate.

References:

Brusie, C. (2025, May 05). HCA CEO pay gap widens in 2024; The eye-popping compensation of high-paid hospital CEOs. Bellevue, WA: Nurse.org: News. https://nurse.org/news/hospital-ceo-pay/

National Labor Relations Board. (n.d.). 1974 Health Care Amendments. Washington, DC: National Labor Relations Board: About NLRB: Who We Are: Out History. https://www.nlrb.gov/about-nlrb/who-we-are/our-history/1974-health-care-amendments

North Carolina State Health Plan for Teachers and State Employees. (2023, February 14). Hospital executive compensation: A decade of growing wage inequity across nonprofit hospitals. Raleigh, NC: North Carolina State Health Plan for Teachers and State Employees. https://www.shpnc.gov/nonprofit-hospital-executive-pay-report/open

Paavola, A. (2020, April 07). 266 hospitals furloughing workers in response to COVID-19. Chicago, IL: Becker’s Hospital Review: Finance. https://www.beckershospitalreview.com/finance/49-hospitals-furloughing-workers-in-response-to-covid-19/

Prager, E. & Schmitt, M. (2021). Employer consolidation and wages: Evidence from hospitals. American Economic Review, 111(2), 397-427. http://dx.doi.org/10.1257/aer.20190690

Rosseter, R. (2024, April). Nursing Workforce Fact Sheet. Washington, DC: American Association of Colleges of Nursing: News & Data: Fact Sheets. https://www.aacnnursing.org/news-data/fact-sheets/nursing-workforce-fact-sheet

Shabad, A. (2020, May 04). North Carolina is low or completely out of certain critical supplies of PPE. WNCN Charlotte: Articles: News: Health: Coronavirus. https://www.wcnc.com/article/news/health/coronavirus/north-carolina-low-completely-out-critical-supplies-ppe/275-560d5b3e-172c-4e07-bf1d-f0e4524a5190

U.S. News. (2025). Best-Paying Jobs. Washington, DC: U.S. News: Money: Careers: Best Jobs: Best-Paying Jobs. https://money.usnews.com/careers/best-jobs/rankings/best-paying-jobs

University of St. Augustine for Health Sciences. (2024, December 30). Nursing shortage: A 2024 data study reveals key insights. St. Augustine, FL: University of St. Augustine for Health Sciences: Blog. https://www.usa.edu/blog/nursing-shortage/

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.

Discontent and Lack of Trust Swirls Around RFK Jr

By: Ranier Simons, ADAP Blog Guest Contributor

Public health affects all Americans, regardless of their political ideology, religious beliefs, or socioeconomic background. The vast majority of the public also lacks an extensive medical or scientific background. Thus, citizens look to established institutions and entities for guidance on best health practices as they go about their busy lives. Consequently, the instability caused by the current state of upheaval in the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control & Prevention (CDC) is a public health hazard. The trust gap the average American has with RFK Jr. should not be trivialized, as it is having ripple effects throughout public discourse and the medical establishment.

Photo Source: STAT News

RFK Jr. has a very high-profile stance that many describe as being anti-vaccine. Although he does not hold a medical degree and has no prior experience as an environmental attorney, he has characterized the historically internationally respected CDC as a corrupt institution that has failed the American public (Soucheray, 2025). This sentiment is especially notable in his characterizations of COVID-19 vaccines and childhood vaccinations. Scientific data show that COVID-19 vaccinations worldwide prevented approximately 2.5 million deaths between December 2020 and October 2024 (John et al., 2025). Statistics such as this significantly damage his credibility.

A recent poll, conducted by The Economist and YouGov and surveying 1,691 adults, indicated that only one in four Americans trusts RFK Jr. with medical advice (Crisp, 2025). Approximately 51% of respondents stated they still trust CDC guidance, and 79% stated they trust the medical recommendations of their personal physicians (Crisp, 2025). Notably, 45% expressed disapproval of Kennedy’s job as HHS secretary.

Experienced career staff at HHS have also raised questions about RFK Jr.’s trustworthiness. A recent shooting at the CDC resulted in six CDC buildings sustaining damage and one police officer being killed (Fields, 2025). 

In response, on August 20th, over 750 current and former HHS staff members issued a letter addressed to HHS Secretary Kennedy and Congress asking him to stop spreading inaccurate health information. The letter expressed that, “The attack came amid growing mistrust in public institutions, driven by politicized rhetoric that has turned public health professionals from trusted experts into targets of villainization—and now, violence…Health and Human Services Secretary Robert F. Kennedy, Jr., is complicit in dismantling America’s public health infrastructure and endangering the nation’s health by repeatedly spreading inaccurate health information…”.

Photo Source: STAT News

On September 3rd, over 1000 current and former HHS staff released another letter asking him to resign. The public cannot foster trust in the head of HHS when internal members of HHS are calling for his resignation.

Even amidst the recent outbreak of measles, RFK Jr.'s stance on childhood vaccines is fostering conflicting messaging and confusion. Recently, Florida’s Surgeon General announced that the state would be the first to end all vaccine mandates, including those for schoolchildren (Kearney, 2025). For years, all 50 states and the District of Columbia have had laws requiring school children to be vaccinated against diseases such as polio and measles. Despite the Florida Surgeon General’s announcement, a recent survey conducted by The Washington Post and the Kaiser Family Foundation (KFF) indicates 82% of Florida parents support public schools requiring vaccines for measles and polio, with some health and religious exemptions. Comparatively, 81% of parents nationwide also support school vaccine requirements.

In June of this year, HHS Secretary Kennedy fired all 17 members of the Advisory Committee on Immunization Practices (ACIP) (Stone, 2025). This committee helps develop vaccine policy and recommendations for the CDC. Kennedy stated that he removed all the members because he felt they all had conflicts of interest, as indicated in a government report (Huang, 2025). However, it has been documented that Kennedy’s interpretation of the report is inadequate, given that it is almost twenty years old, dating back to 2009. Dr. Tom Frieden, CDC director from 2009 to 2017, publicly stated Kennedy was giving “a total misrepresentation of a 20-year-old report, about a process that was already being improved before that report was issued” (Huang, 2025). Secretary Kennedy subsequently replaced the old members with several individuals who had previously expressed anti-vaccine sentiments.

Out of grave concern for public health, the American Academy of Pediatrics (AAP) recently published its own 2025 recommended schedule for child and adolescent immunization, which differs from the current CDC's ACIP (Gerlach, 2025). The AAP is outwardly challenging the current CDC guidelines, stating its recommendations are evidence-based. Susan J. Kressly, MD, AAP president, said in a statement, “The AAP will continue to provide recommendations for immunizations that are rooted in science and are in the best interest of the health of infants, children, and adolescents” (Gerlach, 2025). She added, “Pediatricians know how important routine childhood immunizations are in keeping children, families, and their communities healthy and thriving” (Gerlach, 2025). Among the significant divergences from CDC ACIP guidance, the AAP recommends universal COVID-19 vaccination for children aged 6 to 23 months and risk-based immunization for children aged 2 to 18 years, such as those who are medically vulnerable or living with high-risk individuals (Gerlach, 2025).

Photo Source: ABC30

Some Democrat-led states are also pushing back against the current CDC ACIP advisories. Massachusetts recently became the first state to issue its own vaccine rules. Governor Maura Healey announced that health insurers doing business in Massachusetts will be required to cover vaccines recommended by the state health department, regardless of whether the CDC recommends them or not. Blue Cross Blue Shield of Massachusetts and the Massachusetts Association of Health Plans support the policy (Goldman, 2025 Sept.4) California, Oregon and Washington have formed what is being called the West Coast Health Alliance to issue their own vaccine recommendations to battle the politicization of the CDC (Goldman, 2025 Sept.3). New Mexico recently through its health department issued and order that all its residents can obtain COVID-19 vaccinations even though Kennedy announced they should be restricted to high-risk patients (Goldman, 2025, September 5).

Just this week, PlusInc – an organization promoting health equity – issued a strongly worded rebuke of RFK Jr's assertion that there is a definitive link between Tylenol and autism. The statement, in part, reads: "Monday’s disorganized pronouncement was made with either complete unawareness or discounting of findings from a study published just last year in JAMA Network that found no link between the use of acetaminophen and children’s risk of autism, attention-deficit/hyperactivity disorder (ADHD), or any intellectual disabilities."

Distrust in RFK Jr’s leadership is adversely disruptive to public health and problematic for the evidence-based established infrastructure of medical science. Moreover, since states have the legal latitude to create their own health policies and guidance, the result could lead to a patchwork quilt of public health protections that vary from state to state. The public will ultimately be left with apprehension regarding health decisions, and states may face retaliatory funding responses from the federal government. The trust gap between RFK Jr. and the American public is not merely an issue of political theater, but a threat to the lives of citizens.

[1] Crisp, E. (2025, September 3). 1 in 4 Americans trust RFK Jr. with medical advice. Retrieved from https://thehill.com/policy/healthcare/5484579-kennedy-poll-medical-advice/

[2] Fields, A. (2025, August 12). 500 shots fired in CDC attack in Atlanta. Retrieved from https://thehill.com/homenews/state-watch/5447797-gunman-cdc-headquarters/

[3] Gerlach, A. (2025, August 21). American Academy of Pediatrics Releases 2025 Child, Adolescent Immunization Recommendations. Retrieved from https://www.pharmacytimes.com/view/american-academy-of-pediatrics-releases-2025-child-adolescent-immunization-recommendations

[4] Goldman, M. (2025, September 4). Massachusetts becomes first state to impose its own vaccine coverage rules. Retrieved from https://www.axios.com/2025/09/04/massachusetts-vaccine-coverage-rules

[5] Goldman, M. (2025, September 3). 3 western states form vaccine alliance to counter feds. Retrieved from https://www.axios.com/2025/09/03/cdc-vaccine-washington-california-oregon-guidelines-recommendations

[6] Goldman, M. (2025, September 5). Blue states eye rival health rules to defy RFK Jr.. Retrieved from https://www.axios.com/2025/09/05/rfk-vaccine-rule-states-democrats-vaccine-rules

[7] Huang, P. (2025, March 11). RFK says most vaccine advisers have conflicts of interest. A report shows they don't. Retrieved from https://www.npr.org/sections/shots-health-news/2025/03/11/nx-s1-5323771/rfk-jr-vaccine-advisers-conflicts-interest

[8] John, Pezzullo, A. M., Cristiano, A., & Boccia, S. (2025). Global Estimates of Lives and Life-Years Saved by COVID-19 Vaccination During 2020-2024. JAMA Health Forum, 6(7), e252223–e252223. https://doi.org/10.1001/jamahealthforum.2025.2223

[9] Kearney, A. (2025, September 4). Most Parents Nationally and in Florida Want Schools to Require Vaccines. Retrieved from https://www.kff.org/quick-take/most-parents-nationally-and-in-florida-want-schools-to-require-vaccines/

[10] Soucheray, S. (2025, September 4). In heated Senate committee meeting, RFK Jr says fired CDC chief lied about ouster. Retrieved from https://www.cidrap.umn.edu/anti-science/heated-senate-committee-meeting-rfk-jr-says-fired-cdc-chief-lied-about-ouster#:~:text=During%20the%203%2Dhour%20meeting,see%20today's%20CIDRAP%20News%20story).

[11] Stone, W. (2025, June 9). RFK Jr. boots all members of the CDC's vaccine advisory committee. Retrieved from https://www.npr.org/sections/shots-health-news/2025/06/09/nx-s1-5428533/rfk-jr-vaccine-advisory-committee-acip#:~:text=boots%20all%20members%20of%20the%20CDC's%20vaccine%20advisory%20committee,-Listen%C2%B7%203:25&text=Secretary%20of%20Health%20Robert%20F,issue%20statements%20denouncing%20the%20move

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.   

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.

_____________________________________________

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.     

Federal Budget Cuts Undermine Successful Evidence-Based HIV Prevention

By: Ranier Simons, ADAP Blog Guest Contributor

To some people, HIV prevention discourse may seem commonplace or redundant. However, prevention science continues to generate exciting developments, and prevention remains the most effective weapon against the spread of HIV. Highlighting the importance of prevention is especially timely given the looming threat of potential significant cuts to HIV prevention funding in the federal budget.

Photo Source: CDC

In an effort to expand options for widespread pre-exposure prophylaxis utilization (PrEP), researchers are investigating a monthly oral option. Presently, the two oral options for PrEP are Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide), which must be taken daily for the highest efficacy (NIH, 2025). As an alternative to long-acting injectable PrEP therapies, a once-a-month pill option is currently undergoing clinical trials. Taking a monthly pill would increase adherence for people who are not amenable to injections or face barriers to them.

A compound known as MK-8527 could potentially change the HIV prevention landscape. MK-8527 originated from scientists chemically modifying a pre-existing drug called islatravir (Millington, 2025). Islatravir is a member of a class of medications called nucleoside reverse transcriptase translocation inhibitors (NRTTI). NRTTI efficacy for antiviral attributes is established and has potential for long-acting pre-exposure prophylaxis. Early experiments yielded positive results in animal studies. MK-8527 is involved in two clinical studies containing 9,000 subjects worldwide spanning sixteen countries, including young women and adolescent girls in Saharan Africa (Millington, 2025). A once-a-month pill option would expand access to long-acting prevention agents since a pill option does not require administration by trained personnel or special storage and handling.

Photo Source: Drug Hunter

The recent U.S.Food & Drug Administration (FDA) approval of Yeztugo (lenacapavir) is another promising development. Yeztugo is a long-acting twice-a-year injection for PrEP. Lenacapavir is a promising discovery that the journal Science named as its 2024 Breakthrough of the Year (Cohen, 2024). A twice-yearly PrEP injectable option is a transformative development, significantly improving access, especially for Black and Latine populations, which are disproportionately affected by HIV in the United States, especially in the South. The on ramping of Yeztugo is simple. On the first day, a person receives two pills and two injections via the abdomen or thigh. The second day requires taking two more pills, then after that, just two injections every six months (Smith, 2025). Overcoming multifactorial barriers to PrEP access in Black and Brown communities is vital in fighting the HIV epidemic.

Despite the importance of HIV prevention and the forward momentum of scientific advances, funding dangers pose a threat. The Fiscal Year 2026 funding bill released by the Appropriations Committee of the U.S. House of Representatives calls for massive reductions. The bill calls for over $1.7 billion in funding cuts for domestic HIV prevention, treatment, and care programs (Chibbaro Jr., 2025). It would also cut the Ryan White HIV/AIDS Care and Treatment Program by $525 million, which is a twenty percent cut.

This level of funding reduction would significantly harm national prevention efforts. Passing the bill would kill the Ending the HIV Epidemic Initiative program and eliminate federal funding for all HIV prevention programs. State and local health departments are heavily dependent on this funding, as states do not have sufficient budgets to cover the requirements for effective community service. Carl Schmidt, executive director of the HIV + Hepatitis Policy Institute, in a statement on September 1st, said, “Eliminating all HIV prevention means the end of state and local testing and surveillance programs, educational programs, and linkage to lifesaving care and treatment, along with PrEP” (Chibbaro Jr., 2025). He further added, “It will translate into an increased number of new HIV infections, which will be costlier to treat in the long run” (Chibbaro Jr., 2025).

Photo Source: POZ

Evidence-based research continues to inform that more prevention efforts, such as increased testing, are needed, not fewer. A recent study published in the journal Clinical Infectious Diseases indicates that increased HIV testing in urgent care and emergency departments has positive outcomes. The study took place across 26 urgent care centers and 22 emergency departments in Utah’s Intermountain Health nonprofit health system. Researchers found that urgent care centers and emergency departments functioning as safety nets are where many people receive their care, including for STIs (Seibert et al., 2025).

The Seibert study was an intervention that alerted clinicians to co-test individuals for HIV whenever testing for gonorrhea and chlamydia was performed. Although this would seem to be a logical approach, it was not being consistently done. The electronic health record (EHR) alert prompted HIV co-testing coupled with a system-wide simultaneous implementation of provider and patient education and a link-to-care program for people newly diagnosed with HIV (Seibert et al., 2025). The study resulted in a 41.9% increase in HIV co-testing rates in the urgent care centers and a 53.4% increase in the emergency departments (Seibert et al., 2025). The increased co-testing resulted in 17 new diagnoses of HIV, and those individuals were promptly linked to care. The study only examined HIV co-testing alerts for those seeking tests for gonorrhea and chlamydia. Additional studies would reveal the benefit of also increasing HIV co-testing when STI testing for other diseases is requested.

HIV prevention efforts save lives by preventing people from acquiring HIV and by identifying people living with HIV to enable proper linkage to care, thus reducing the spread of the disease. Human life and population health are not simple line items on a budget spreadsheet. Reducing funding for HIV prevention will cost lives and increase health care expenditures in the long run. Whatever form of the House budget that passes will have to be reconciled with the Senate version. The future of U.S. HIV prevention will be substantially affected by the outcome.

[1] Chibbaro Jr., L. (2025, September 3). House GOP seeks to cut all U.S. HIV prevention programs in 2026. Retrieved from https://roughdraftatlanta.com/2025/09/03/gop-bill-slashes-hiv-funding/

[2] Cohen, J. (2024, December 12). 2024 Breakthrough of the year. Retrieved from https://www.science.org/content/article/breakthrough-2024#section_breakthrough

[3] Millington, H. (2025, August 26). HIV: Monthly PrEP drug candidate shows promise. Retrieved from https://www.msn.com/en-us/health/other/hiv-monthly-prep-drug-candidate-shows-promise/ar-AA1LgFAK?ocid=socialshare

[4] Seibert, A. M., Matheu, M., Buckel, W. R., Bledsoe, J., Willis, P., Balls, A., Butler, A. M., Moores, T. D., Vines, C., Hellewell, J., Smout, R., Lopansri, B., Stanfield, V., Fino, N. F., Wormser, V. R., Gutierrez, A., Gwiazdon, M., Wallin, A., Patel, P. K., & Hersh, A. L. (2025). Increasing HIV Testing During Gonorrhea and Chlamydia Evaluations in Urgent Care and Emergency Departments: A Large Health System Initiative. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciaf434. Retrieved from https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf434/8244966

[5] Smith, J. (2025, September 3). The First Twice-Yearly Tool to Prevent HIV Holds Promise for Black & Brown Communities. Retrieved from https://blackdoctor.org/twice-yearly-tool-to-prevent-hiv-holds-promise/

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.   

CVS Caremark Plays Kicks-the-Can on Yeztugo; Undermines HIV Prevention Efforts

By: Ranier Simons, ADAP Blog Guest Contributor

Benjamin Franklin is credited with the phrase, ‘An ounce of prevention is worth a pound of cure.’ In simple terms, it is easier to prevent a negative outcome from happening than to expend energy repairing damage that has already occurred. This is especially true regarding HIV. Given that there is currently no cure for the virus, it is imperative to prevent HIV transmission. Recent innovations, especially long-acting injectable agents, have expanded the toolbox of HIV prevention. Consequently, the mere existence of life-saving tools is not beneficial if the people who need them are denied access. CVS Caremark recently announced that it will not be adding coverage for Yeztugo (lenacapavir), Gilead Sciences' bi-annual HIV PrEP injectable, to its commercial plans (Beasley, 2025).

Pharma.com | The Economic Times

Yeztugo was approved by the U.S. Food and Drug Administration (FDA) in June 2025, following the successful outcomes of its Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2. Approximately 99.9% of participants remained HIV negative, proving Yeztugo in the trial to be more effective than daily Truvada administered as PrEP (Gilead, 2025). Out of the 2,179 participants in the PURPOSE 2 trial, only two people contracted HIV.

Medicare, Veterans’ Administration, and some Medicaid plans are already covering Yeztugo. In contrast, CVS Caremark has stated that it will not cover the drug in its commercial plans, nor in any of its Affordable Care Act (ACA) formularies. CVS follows the recommendations of the U.S. Preventive Services Task Force (USPSTF) for HIV prevention medications. Presently, USPSTF only recommends daily Truvada (Gilead), Descovy (Gilead), and the bimonthly injectable Apretude (ViiV). Prevention measures recommended by the USPSTF must be covered without any patient cost-sharing. Many in the HIV care community are concerned about Yeztugo ever being recommended by the USPSTF, given the current paradigm of the embattled JFK Jr.-led U.S. Department of Health and Human Services (HHS) (Beasley, 2025).

Photo Source: Metro Weekly

In a statement emailed to the publication Fierce Pharma, a CVS spokesperson explained, “As is typical with new-to-market products, we undergo a careful review of clinical, financial, and regulatory considerations, under the guidance of our external Pharmacy and Therapeutics (P&T) Committee of independent medical experts” (Kansteiner, 2025). Given that Medicare, Veterans’ Administration, and some state Medicaid plans (including California and New York) are already covering Yeztugo, and it has had stellar results in its clinical trials, it is unclear what clinical, financial, and regulatory considerations are of concern. Those in the HIV care community feel CVS’s decision is based on Yeztugo’s list price of $28,000 per year for the two injections. The average lifetime cost of treating a person living with HIV ranges from $420,285.00 to over $1 million (Bingham et al., 2021). Thus, in the long term, preventative treatment would appear cost-effective.

Notably, CVS Caremark is currently embroiled in legal disputes. Chief Judge Mitchell Goldberg, a Philadelphia federal judge, issued a ruling ordering CVS Caremark to pay a $289.9 million judgment for fraudulent prescription drug charges to Medicare. Initially, the penalty issued was $95 million (Stempel, 2025). In 2014, a former head actuary for Medicare Part D at Aetna initiated a whistleblower case, accusing CVS Caremark of causing health insurers to file false and inflated claims to the Centers for Medicare and Medicaid Services (CMS), while paying Rite Aid and Walgreens pharmacies less. The judge explained that CVS knowingly manipulated drug pricing to its financial benefit. Due to the motivations and intent of CVS, Judge Goldberg, using the False Claims Act, tripled the $95 million and added a $4.87 million civil fine. 

CVS is being admonished for causing fiscal harm to the government via CMS, as well as weakening public trust in the CMS. Judge Goldberg wrote, “CMS relies on companies like Caremark to truthfully and accurately report Part D drug prices," he wrote. "Caremark's conduct broke CMS's trust, and as a result, the public's trust in CMS." In the decision, Judge Goldberg specifically spelled out, “ Caremark devised a scheme to earn hidden spread or indirect profit on Part D purchases, and in the process, caused CMS to over-subsidize prescription drug costs to the tune of some $95 million. When CMS and other industry participants asked questions, Caremark consistently concealed the true nature of its scheme”. In addition to this case, CVS is appealing a separate $948.8 million judgment against its Omnicare unit, issued by a Manhattan federal judge in July, over allegations of fraudulent billing.

Photo Source: Review of Optometric Business

This pattern of profit-motivated questionable behavior is additional reasoning for why CVS’s initial decision not to cover Yeztugo is causing concern among many stakeholder groups. Yeztugo is a way to ensure adherence, given that it is only administered twice a year. It is crucial to increase the possibility of preventing HIV acquisition among those at high risk, not reduce it. Prevention reduces health care expenditures for the system and the individual. 

Stakeholders like Brian Hujdich, Executive Director at HealthHIV, explain the quandary: “It’s hard to reconcile Franklin’s wisdom together with CVS’s decision. Long-acting PrEP injectables could prevent unnecessary transmission, medical costs, and sick days, while reducing the time and effort required to stay protected. They can also help minimize situations where stigma commonly shows up — whether internal, like the stress of daily pill-taking, or external, like repeated pharmacy pickups and clinic visits — while supporting people to stay healthy.”

[1] Beasley, D. (2025, August 21). CVS holds off adding Gilead’s new HIV prevention shot to drug coverage lists. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/cvs-holds-off-adding-gileads-new-hiv-prevention-shot-drug-coverage-lists-2025-08-20/

[2] Bingham, A., Shrestha, R. K., Khurana, N., Jacobson, E. U., & Farnham, P. G. (2021). Estimated Lifetime HIV-Related Medical Costs in the United States. Sexually transmitted diseases, 48(4), 299–304. https://doi.org/10.1097/OLQ.0000000000001366

[3] Gilead Sciences. (2025, June 18). Press Release: Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. Retrieved from https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection#:~:text=In%20the%20PURPOSE%202%20trial,with%20once%2Ddaily%20oral%20Truvada

[4] Kansteiner, F. (2025, August 21). For now, CVS declines to cover Gilead's long-acting HIV PrEP treatment Yeztugo. Retrieved from https://www.fiercepharma.com/pharma/now-cvs-declines-cover-gileads-twice-yearly-hiv-prep-treatment-yeztugo

[5] Stempel, J. (2025, August 20). CVS unit must pay $290 million in drug whistleblower lawsuit, judge rules. Retrieved from https://www.reuters.com/legal/government/cvs-unit-must-pay-290-million-drug-whistleblower-lawsuit-judge-rules-2025-08-20/#:~:text=In%20a%20Tuesday%

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.