DOGE-related Funding Cuts Threaten the Fight to End the HIV Epidemic

By: Ranier Simons, ADAP Blog Guest Contributor

Actions driven by the so-called Department of Government Efficiency (DOGE) continue destabilizing the U.S. public health and scientific research infrastructure. Funding cuts, including eliminating grants and dismissing thousands of employees at the National Institutes of Health (NIH) and Center for Disease Control & Prevention (CDC), are being announced increasingly quickly. The onslaught of DOGE actions is aggressively wielding a hatchet from multiple angles without guidance to those affected, leaving confusion and a paucity of guidance in its wake. Diverse stakeholders are concerned about the potentially grave impending impacts of these cuts on the fight to end the HIV epidemic and public health overall.

Photo Source: NBC News

One notable loss was incurred by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Recently, NIH announced the halt of two of its principal funding grants, pulling $18 million annually from its operations (Oza, 2025). The ATN was established over 20 years ago when evidence-based research identified the very specific needs of adolescents and young adults living with HIV as compared to children born with HIV or adults living with HIV. The ATN’s work includes several multidisciplinary clinical trials aimed at improving HIV prevention, as well as treatment improvements across the entire HIV care continuum for youth, which are all being eliminated. One of the many successes of ATN is the development of a PrEP protocol for adolescents, which was approved in 2018. The termination of funding effectively terminates current trials, such as examining doxycycline prophylaxis in women and an investigational study for a multipurpose injectable to prevent HIV and pregnancy (Oza, 2025).

NIH grant cuts are also targeting health equity research. Health equity research seeks to identify and address avoidable adverse health outcomes experienced by specific populations due to social determinants of health, including socioeconomic status and race (Braveman et al., 2017). The current administration does not appear to recognize health disparities as a credible public health threat and views the work as baseless DEI conjecture. 

One such canceled grant involved research on maternal health. Jaime Slaughter-Acey, an associate professor at the University of North Carolina at Chapel Hill, was studying the poor maternal health and birth outcomes of black women (Hellman, 2025). The health crisis of poor maternal and infant mortality among black women is backed by sound scientific data and is a recognized consensus in the medical community. The risk of maternal mortality is the most significant disparity among all conventional population perinatal health measures, regardless of geographic location (Krishnamoorthi et al., 2023). 

Photo Source: Inquisitr

Multiple health disparity grants specifically focused on LGBTQ issues have also been canceled. For example, several researchers at George Washington University lost grants for studies exploring HIV outcomes in minority populations (Lee, 2025). NIH grant funding was canceled for Jonathon Rendina, an associate research professor of public health, who was studying the inequities of HIV experienced by women and transgender people of color. The research was already underway and will lose $1.4 million that had not yet been spent. Derek Dangerfield II, an associate professor of prevention and community health, lost two grants. His grants funded studies investigating healthcare outcomes and systemic stigma in the healthcare system for Black men living with HIV. Together, both grants took almost $1.5 million away (Lee, 2025).

Explicitly, NIH has targeted and canceled funding for transgender health studies. It has issued internal guidance stating it no longer supports any research on transgender health issues or gender identity (Kozlov, 2025). Sari Reisner, associate professor of epidemiology at the University of Michigan, lost his grant entitled “Strategies to Prevent HIV Acquisition Among Transgender MSM in the US” (Spring, 2025). At least five of seven recently canceled grants at the University of Michigan involved gender identity research. Studies show that HIV disproportionately impacts transgender individuals. Transgender women are 49 times more likely to have HIV compared to the general population, and transgender men have higher rates of HIV acquisition as well (Baral et al., 2012).

Transgender health, in general, has been under consistent attack. Shanna Kattari, an associate professor of social work and women’s studies at the University of Michigan, explains, “The current political climate and anti-trans attacks have already harmed healthcare access for transgender and gender-diverse (TGD) people, from directly clinics shutting down puberty blocks or HRT for young people … to more indirectly, (where) many TGD people (are) choosing to avoid needed care, whether preventative care or gender-affirming care, due to fear of being denied, mistreated or being put on a ‘list’ for accessing such care” (Spring, 2025).

Photo Source: THEM

The majority of those receiving notification of their grant funding by NIH received letters with verbiage expressing that NIH no longer holds their research as a priority. The letters state, “Research programs based primarily on artificial and non-scientific categories, including amorphous equity objectives, are antithetical to the scientific inquiry, do nothing to expand our knowledge of living systems, provide low returns on investment, and ultimately do not enhance health, lengthen life, or reduce illness…”(Spring, 2025). They further legitimize their choice to defund, adding, “…so-called diversity, equity, and inclusion (“DEI”) studies are often used to support unlawful discrimination on the basis of race and other protected characteristics, which harms the health of Americans. Therefore, it is the policy of NIH not to prioritize such research programs”(Spring, 2025).

There is a human toll to the Trump Administration's slash and burn. Michigan resident Jeremy Toney summarized, "Being directly affected by these recent funding cuts to public health, specifically HIV prevention and research, has left me feeling very uncertain about the future. My team and I experienced a massive direct cut to our NIH R01 research grant that was set to change how we look at HIV Prevention in Primary Care from a health system perspective. We were on the heels of implementation as we put time and effort into building a project from scratch. The devastation of our grant being terminated without warning and true reason is quite egregious and speaks to how this current administration views science and the work that so many credible individuals have put into saving lives. We're all feeling unsafe and uncertain about the future of our jobs, the loss of impactful research, and the distrust of the government, but we must fight back against it."

Population health is not an amorphous equity objective. HIV prevention and treatment studies do indeed enhance health, lengthen life, and reduce illness. The average estimated lifetime HIV-related medical expenditure per individual in the U.S. is around $420K (Bingham, 2021). Saving over $420K per person by preventing HIV infection is a significant return on investment. Medical knowledge gained from the study of population subsets can be expanded to application to the general population. That is the epitome of expanding our knowledge of living systems. As we continue to monitor ongoing DOGE-related funding cuts and “reductions in force,” it is imperative to find ways to mitigate the present dangers as well as offensively protect the future.

[1] Baral, S. D., Poteat, T., Strömdahl, S., Wirtz, A. L., Guadamuz, T. E., & Beyrer, C. (2012). Worldwide burden of HIV in transgender women: a systematic review and meta-analysis. The Lancet Infectious Diseases, 13(3), 214–222. https://doi.org/10.1016/s1473-3099(12)70315-8. Retrieved from https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(12)70315-8/fulltext

[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. Retrieved from https://pubmed.ncbi.nlm.nih.gov/33492100/#:~:text=Results:%20We%20estimated%20an%20average%20lifetime%20HIV%2Drelated,and%20$326%2C411%20in%20our%20least%20favorable%20scenario.

[3] Braveman, P., Arkin, E., Orleans, T., Proctor, D., Plough, A. (2017, May 1). What is health equity? Retrieved from https://www.rwjf.org/en/insights/our-research/2017/05/what-is-health-equity-.html#:~:text=In%20a%20report%20designed%20to,in%20discussions%20around%20the%20concept.

[4] Hellman, J. (2025, March 24). Trump cancels NIH grants on equity research. Retrieved from https://www.msn.com/en-us/health/other/trump-cancels-nih-grants-on-equity-research/ar-AA1BzOLx?ocid=socialshare

[5] Kozlov, M. (2025, March 26). Exclusive: NIH to cut grants for COVID research, documents reveal. Retrieved from https://www.nature.com/articles/d41586-025-00954-y

[6] Krishnamoorthi, M., Balbierz, A., Laraque-Arena, D., & Howell, E. A. (2023). Addressing the National Crisis Facing Black and Latina Women, Birthing People, and Infants: The Maternal and Child Health Equity Summit. Obstetrics and Gynecology, 141(3), 467–472. https://doi.org/10.1097/AOG.0000000000005067. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC9974748/

[7] Lee, J. (2025, March 31). GW researchers lose five NIH grants amid federal funding cuts. Retrieved from https://gwhatchet.com/2025/03/31/gw-researchers-lose-five-nih-grants-amid-federal-funding-cuts/

[8] Oza, A. (2025, March 25). NIH cuts halt 24-year program to prevent HIV/AIDS in adolescents and young adults. Retrieved from https://www.statnews.com/2025/03/25/nih-cuts-include-hiv-aids-prevention-program-for-adolescents/

[9] Spring, E. (2025, March 26). NIH pulls funding from UMich transgender health research. Retrieved from https://www.michigandaily.com/news/research/nih-pulls-funding-from-umich-transgender-health-research/

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.

Proposed CDC HIV Prevention Funding Cuts Loom Large; Advocates Fear for Treatment Dollars

By: Ranier Simons, ADAP Blog Guest Contributor

The current administration’s interest in a multitude of funding cuts and reorganization of federal programs and entities has been at the forefront of daily news for weeks. Recently, a Wall Street Journal report highlighted information sourced indicating the Trump administration is considering cuts to the CDC’s domestic HIV program (Wyte, Mosbergan, & Rockoff, 2025). Specifically, there are talks of significant cuts in HIV prevention funding, including a reduction of CDC personnel and possible restructuring or elimination of the CDC’s HIV Prevention division. Public health professionals, clinicians, patient groups, and many other stakeholders are alarmed by the detrimental ramifications of the cuts being discussed.

Photo Source: WSJ

There are an estimated 1.2 million people in the U.S. living with HIV, of whom 13% are unaware of their status (Wyte et al., 2025). Those who are unaware they are living with HIV are in dire need of testing to learn of their status and get into treatment. Testing is the cornerstone of HIV prevention. Mitchell Warren, executive director of HIV prevention organization AVAC, when speaking to the Wall Street Journal, stated, “One of the greatest lessons in public health is you can’t end epidemics with treatment alone. Without prevention, we are going to be fighting the virus with one hand behind our back.”

An opposition letter written by Representative Maxine Waters addressed to Robert F Kennedy, Jr., Secretary of the U.S. Health and Human Services delineates a reported elimination of $700 million in CDC HIV prevention funding because of the 2025 Congressional Continuing Resolution (Waters, 2025). HIV prevention funding was only 3% of the federal government’s fiscal expenditure on HIV in FY2022, even though the CDC represents %91% of federal HIV prevention funds. The FY2024 appropriation for HIV prevention at the CDC was approximately $1 billion, and the CDC spent $1.3 billion on HIV, viral hepatitis, STIs, and tuberculosis in FY2023 (Dawson,2025; Wyte et al., 2025). Thus, a $700 million cut is devastating.

The pushback was bipartisan, as evidenced by Representative Mike Lawler's taking to X to express his concern over the reports. "Our country has been at the forefront of the global fight against HIV and AIDS, and now is not the time to cut programming," he tweeted.

Photo Source: X

Additionally, ADAP Advocacy directed a letter to select Members of the North Carolina Congressional Delegation on the same day the Community Access National Network (CANN) appealed to Members of the Louisiana Congressional Delegation. According to the ADAP Advocacy letter, "North Carolina's effort to address HIV is nearly exclusively funded by the federal government. For example, approximately $42.7M was appropriated for the State AIDS Drug Assistance Program (ADAP), as well as prevention programs funded by President Trump's own Ending the HIV Epidemic initiative (EHE, announced in 2019), including a focus on Mecklenburg County." CANN's letter likewise noted the impact on Louisiana, "Louisiana's effort to address HIV is nearly exclusively funded by the federal government. These dollars, as addressed specifically by prevention programs, including President Trump's own Ending the HIV Epidemic initiative (EHE, announced in 2019), include $5.94M for programs, $1.12M for surveillance activities, and an additional $3M associated with EHE activities. In total, this type of "cut" would amount to the state of Louisiana losing more than $10.06M shift in cost to the state for HIV prevention and surveillance activities for the state of Louisiana alone, even as the state faces a fiscal cliff, making it unlikely that state appropriator, despite their best efforts, to be able to fill the gap caused by program elimination."

The majority of CDC HIV prevention funding is not spent on internal administration. The CDC is a primary funding funnel, with funds distributed to state and local health departments, including community health organizations. The Frannie Peabody Center, Maine's largest provider of HIV and AIDS services, has publicly spoken out against the cuts, as there are an estimated 1,800 Maine residents living with HIV. Executive Director Katie Rutherford stated, “Eliminating this division of the CDC would decimate decades of progress that we have made in fighting an end of HIV and AIDS in the U.S.” (WGME, 2025). 

Photo Source: Courage Forward Strategies

HIV disproportionately affects marginalized communities. Thus, cuts in HIV prevention funding would have disproportionately adverse health outcomes for groups such as Black and Latino gay men. In 2022, among the subpopulation of men who have sex with men, 38% of those who were diagnosed with HIV were Black, and 32% were Latino (Reed, 2025). Texas Health Action, a non-profit that operates several branches of culturally affirming Kind Clinic, states, “HIV prevention is a proven, cost-effective public health strategy. Reducing funding doesn’t save money—it leads to more infections and higher long-term healthcare costs. Nearly 5,000 Texans were diagnosed with HIV in 2022 alone. Cutting these essential programs now would be catastrophic for communities that rely on them.” (Texas Health Action, 2025).

Drastic cuts to HIV prevention funding would also harm the youth. In 2022, 1 in 5 new HIV diagnoses were in the 13 to 24-year-old cohort, and 56% of all new cases were among those 34 and younger (Reed, 2025). Raynard Washington, a county health director in Mecklenburg, North Carolina, when speaking to AXIOS news, stated, “There is nothing more heartbreaking than having to tell a 14-year-old that they have an illness that they won't be able to cure, and they'll have to take medication in various forms for the rest of their life” (Reed, 2025). Sexually active 13-24-year-olds have the highest probability of living with undiagnosed HIV and have lower rates of viral suppression (Hsu & Rakhmanina, 2024). It is imperative to strengthen HIV prevention and education efforts for the youth, not defund them.

In addition to the funding cuts, the administration is considering dismantling the CDC HIV Prevention Department and placing HIV prevention funding under HHS, such as with HRSA. This is also faulty reasoning. The CDC and HRSA are functionally separate entities. HRSA is tasked with HIV healthcare service delivery through the Ryan White HIV/AIDS Program. By statute, except for PrEP delivery at community centers, it is prohibited from providing most HIV prevention services for which the CDC is experienced and structured (Dawson, 2025). Moreover, the Substance Abuse and Mental Health Services Administration (SAMHSA) is considering cuts to its HIV programs (Waters, 2025). SAMHSA funding is crucial because it directs intervention to those who benefit from HIV prevention and substance addiction treatment. Reducing CDC HIV prevention funding, in addition to markedly reducing SAMHSA HIV-related funding, further leaves vulnerable populations subject to increases in HIV transmission and poor health outcomes from poor linkages to care.

Photo Source: HIVMA

During President Trump’s 2019 State of the Union address, he announced a heightened focus on eliminating HIV in the U.S. within ten years (Dawson, 2025). The administration’s Ending the HIV Epidemic in the U.S. Initiative (EHE) aimed to reduce new HIV infections by 90% by 2030. The current discussion of massive cuts to CDC HIV prevention funds starkly contrasts the 2019 EHE goals. Slashing HIV prevention funding means the destruction of programs for outreach, HIV surveillance, PrEP access, and seamless linkages to care.

In a joint statement put out by ADAP Advocacy and Community Access National Network (CANN), Jen Laws, CANN President & CEO, gave a fitting summation of the damage cutting HIV prevention programs will cause. He said, “Prevention programs further support treatment programs with testing, screening activities, and linkage to care upon reactive tests. The economic impact of these programs can be measured in more jobs, more clinics, healthier families, and more productive employees. Conversely, cutting these programs and their associated funding will be measured in terms beyond economic loss. It would be measured in the human toll, the harm to our communities, untreated illness, late diagnoses, families torn apart, and lives lost." (Macsata & Laws, 2025).

[1] Dawson, L. (2025, March 19). Cutting HIV Prevention Funding at CDC: What Would it Mean? Retrieved from https://www.kff.org/quick-take/cutting-hiv-prevention-funding-at-cdc-what-would-it-mean/

[2] Hsu, K., Rakhmannina, N. (2024, May 17). HIV in Children and Teens. Retrieved fromhttps://www.healthychildren.org/English/health-issues/conditions/sexually-transmitted/Pages/HIV-Human-Immunodeficiency-Virus.aspx

[3] Macsata, B., Laws, J. (2025, March 19). Joint Statement On Reported HIV Prevention Funding Cuts. Retrieved from  https://www.adapadvocacy.org/pdf-docs/202_ADAP_Press_Proposed_Cuts_HIV_Prevention_03-19-25-CANN-Joint-Statement.pdf

[4] Reed, T. (2025, March 20). Young people could be most at risk with HIV prevention cuts. Retrieved from https://www.axios.com/2025/03/20/cdc-hiv-prevention-cuts-trump-young-people

[5] Texas Health Action. (2025, March 18). Texas Health Action responds to proposed cuts in HIV prevention funding. Retrieved from  https://dallasvoice.com/texas-health-action-responds-to-proposed-cuts-in-hiv-prevention-funding/

[6] Waters, M. (2025, March 18). Letter to Robert F. Kennedy, Jr. regarding CDC HIV Prevention funding cuts. 

[7] WGME. (2025, March 19). Maine provider for HIV, AIDS services criticizes Trump administration cuts. Retrieved from https://www.msn.com/en-us/health/other/maine-provider-for-hiv-aids-services-criticizes-trump-administration-cuts/ar-AA1BgFhD?ocid=socialshare

[8] Wyte, L., Mosbergan, D., Rockoff, J. (2025, March 18). Trump Administration Weighing Major Cuts to Funding for Domestic HIV Prevention. Retrieved from https://www.wsj.com/health/healthcare/trump-administration-weighing-major-cuts-to-funding-for-domestic-hiv-prevention-8dcad39b

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.

NASTAD Releases 2025 Monitoring Project Annual Report

By: Ranier Simons, ADAP Blog Guest Contributor

The National Alliance of State and Territorial AIDS Directors (NASTAD) has released its 2025 National RWHAP Part B ADAP Monitoring Project Annual Report. This is the 28th year of the report, which documents key trends, challenges, and triumphs of state and territorial AIDS Drug Assistance Programs (ADAPs). The report is based on longitudinal data acquired through survey responses. The data covers fiscal year 2023 (FY2023) and calendar year 2023 (CY2023). Of the 58 surveyed jurisdictions that received ADAP earmark funding, 49 provided data. No fiscal or programmatic data were received from Alabama, Montana, West Virginia, the U.S. Virgin Islands, or the Pacific Island Jurisdictions. Limited programmatic data were received from Alaska and South Dakota.

Photo Source: NASTAD

Key findings from this year’s report include:

• Ryan White Part B program funding remained flat. Congressional appropriations for RWHAP Part B in FY2023 was $1.3 billion, with $899.7 million awarded explicitly to ADAP from HRSA. This was the same level of funding as in FY2022.
• Pharmaceutical rebates accounted for the largest share of the overall FY2023 ADAP budget, at 50%. Federal ADAP earmark funding constituted 31%
• The total number of clients enrolled, the number of new clients enrolled, and total number of clients served increased from FY2022. There were 4.7%, 15%, and 4% increases, respectively. 
• Out of the top ten states with the highest number of ADAP clients served, Florida was first serving 29,883 clients, and California was second serving 28,123 clients.
• Of all ADAP clients surveyed from responding jurisdictions during CY2023, 41% had incomes at or below 100% of the federal poverty level (FPL). The majority of ADAP clients, 66%, have incomes at or below 200% FPL.
• In CY2022, 42%, less than half of clients served were people of color, with the majority identifying as Black/African American. In CY2023, 38% of ADAP clients served were Black/African American, compared to 46% in CY2018. Conversely, the proportion of White ADAP clients increased to 54% in CY2023 from 40% in CY2018. Hispanic/Latinx clients comprised 33% of CY2023 clients served compared to 21% in CY2018.
• Biktarvy constituted the majority of ADAP antiretroviral drug expenditures

Photo Source: NASTAD

Discussion

One of the primary goals of Ending the HIV Epidemic in the U.S. (EHE) is viral suppression (Centers for Disease Control and Prevention [CDC], 2024, Mar 20). Of the 47 jurisdictions that provided data, 85% of ADAP clients served in CY2023 reported viral suppression. Comparatively, out of 47 reporting programs in CY2014, 63% reported viral suppression, and out of 53 reporting programs in CY2018, 80% reported viral suppression. These increasing numbers are evidence that ADAP programs are effective and worthwhile public health expenditures. Moreover, CY2023 ADAP client viral suppression is vastly higher than the overall percentage of all people in the U.S. living with diagnosed HIV reporting viral suppression in 2022, which was only 65%. (Centers for Disease Control and Prevention [CDC], 2024, Dec 12).

Regarding funding, some state ADAPs are concerned about the prospect of major reductions in federal funding to state Medicaid programs as part of FY2025 Congressional budget processes. This would fiscally adversely affect ADAPs since federal funding reductions would likely not be bolstered by any increased state investment into the Medicaid program. Thus, ADAPs would have to spend more to help those who may lose Medicaid coverage or be unable to transition to Medicaid if there is a loss of expansion.

Moreover, ADAPs provide full-pay medication assistance as well as ADAP-funded insurance programs for which clients' premiums, deductibles, and cost-sharing are paid. In CY2022, ADAPs provided insurance support for 128,418 clients, spending $698 million with an average cost per enrollee of $5,272; in CY2023, ADAPs spent $745 million on 101,502 clients with an average cost of $7344. Total and per-client expenditures were markedly higher in CY2023, although fewer people were served. According to the report there were also 44,033 ADAP clients served who were enrolled in Medicare (Table 18). It is possible to qualify for Medicare and ADAP with ADAP paying for patient cost-sharing of Medicare Part D prescription drugs that ADAPs cover. The changing landscape of insurance assistance proves that more funding is needed, not less.

Photo Source: NASTAD

 Geographically, the annual report reveals a shift in viral suppression trends. The states with less than 80% of ADAP clients with <200 copies/ml viral loads are primarily concentrated in the Midwest (Chart 8). Seven EHE jurisdictions are in the U.S.: Cook County, Illinois; Marion County, Indiana; Wayne County, Michigan; the entire state of Missouri; and Cuyahoga, Franklin, and Hamilton Counties in Ohio (AETC. 2023). This would indicate that research needs to be done to uncover what caused the shift from the lower levels of viral suppression among ADAP clients in the South to ADAP clients in the Midwest.

The 2025 National RWHAP Part B ADAP Monitoring Project Annual Report contains a wide range of data in its pages, tables, and charts. The report is encouraging, proving that the RWHAP program effectively achieves beneficial health outcomes for the clients it serves. It is also an alert to challenges and a forecast of how ADAPs may need to adjust and innovate to survive.

[1] AIDS Education and Training Center (2023, August 4). AETCs and the Ending the HIV Epidemic Initiative. Retrieved from https://aidsetc.org/ehe

[2] Centers for Disease Control and Prevention (2024, March 20). Ending the HIV Epidemic in the US Goals. Retrieved from https://www.cdc.gov/ehe/php/about/goals.html

[3] Centers for Disease Control and Prevention (2024, December 12). National HIV Progress Report, 2024. Retrieved from https://stacks.cdc.gov/view/cdc/170363

[4] National Alliance of State and Territorial AIDS Directors (2025). 2025 Annual Report: National RWHAP Part B ADAP Monitoring Project annual report. Retrieved from  https://nastad.org/2024-rwhap-part-b-adap-monitoring-report

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.

By Rescinding the Richardson Waiver, RFK, Jr Shuts Out Patient Advocates at HHS

By: Ranier Simons, ADAP Blog Guest Contributor

The federal government seeks input from the public to make “informed policy decisions” that affect many aspects of citizens' daily lives. A recent guidance letter from the Office of Management and Budget (OMB) concerning broadening public participation and community engagement states, “Hearing from the individuals and communities most or uniquely affected by a particular issue can help agencies better understand how to address that issue, leading to more responsive and efficient policies and programs…Federal agencies are committed to making it easier for the American people to share their knowledge, needs, ideas, and lived experiences1 to improve how government works for and with them” (OMB, 2025). Yet, a recent rule change issued by the U.S. Department of Health & Human Services (HHS) published in the Federal Register seems to be in opposition to this transparency and public discourse. The rule rescinds the current policy regarding public participation in rulemaking in many areas governed by HHS (HHS, 2025).

Photo Source: Respiratory Therapy | MEDQOR LLC

The new rule upends over 50 years of precedent. The American Procedures Act (APA) established regulations governing how agencies are to operationally issue rules and regulations, including giving the public ample opportunity to comment and provide feedback and data as rules are developed. The law carved out certain exemptions from the requirements: “matter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” (5 U.S.C. 553(a)(2)). Through the Richardson Waiver (36 FR 2532), in 1971, HHS waived the APA statutory exemptions requiring the Department to subject those matters to the APA’s notice and comment rulemaking guidelines. 

By rescinding the Richardson Waiver (McGrath, 2025), which is basically what is being done, newly minted HHS Secretary Robert F. Kennedy, Jr. effectively removes the legal mandate of meaningfully including the public in developing and implementing policies that significantly affect the lives of individuals and industries. Usually, agencies post rules in the Federal Register, open a set comment period of, on average, 60 days to receive public feedback, and then evaluate all the input before they enact finalized rules. Linda Malek, a partner at global law firm Crowell and Moring, points out, “The public comment period is an iterative and educational process that often results in changes of mutual benefit to the government and affected stakeholders (Pugh, 2025).

Numerous stakeholders are alarmed at the potential adverse consequences. Stella Dantas, MD, president of the American College of Obstetricians and Gynecologists (ACOG), said in a statement, “The practice, delivery, and regulation of medicine is incredibly complex. The experiences of patients, clinicians, administrators, and other stakeholders across medicine must be taken into account in order to avoid unintended outcomes.” She added, “Expert input from medical societies, researchers, and patient advocates is necessary "to inform regulatory bodies and ensure the soundness of final rules and other actions” (Clark, 2025).

Photo Source: Healthcare Brew | Chip Somodevilla/Getty Images

The broadness of the rule also concerns many stakeholders because it is unclear how many crucial areas of HHS policy will be affected. The rule rescinds the notice-and-comment practice for HHS “rules and regulations relating to public property, loans, grants, benefits, or contracts.” This does not apply to Medicare because Medicare falls under the provision of the Medicare Act. However, Medicaid, the Substance Abuse and Mental Health Services Administration (SAMHSA), the Administration for Children and Families (ACF), and other agencies under HHS are subject to the new rule (Clark, 2025). 

The ability to push through policies, regulations, and initiatives without partnering with the public means decisions with potentially harmful outcomes would only be public after they were finalized. At that point, the only recourse for remedy from bad policy is suing in court. Alice Bers, JD, litigation director for the Center for Medicare Advocacy, explained that the new rule attempts to avoid public comment on policies that HHS knows will be unpopular (Clark, 2025). 

Verbiage is key when it comes to legal proceedings and government regulations. The new rule states, “The extra-statutory obligations of the Richardson Waiver impose costs on the Department and the public, are contrary to the efficient operation of the Department, and impede the Department's flexibility to adapt quickly to legal and policy mandates” (HHS, 2025). This adds to the concern that the impetus for the rule is to swiftly enact policies, such as ones that would adversely affect Medicaid, that otherwise would not survive public scrutiny or would take longer to modify and implement. Samuel Bagenstos, JD, who served as general counsel to OMB and HHS during the Biden Administration, explains, "For example, if they wanted to allow work requirements under Medicaid, they could do that now ... without going through rule-changing policies" (Clark, 2025). 

Photo Source: Pinterest

HHS is a federal department that exercises policies that directly influence the health and well-being of all Americans. Transparency, communication, and public collaboration are key to ensure HHS policies are developed with the best interests of all affected stakeholders in mind. When the Richardson Waiver was first enacted, it was because there was a recognized need to include scholars, scientists, clinicians, economists, and even patients with lived experiences as part of the policy development process. HHS’s Office of the Assistant Secretary for Planning and Evaluation (Ramirez, 2023) even defines lived experience as “knowledge based on someone’s perspective, personal identities, and history, beyond their professional or educational experience” (Ramirez, 2023). 

Shutting the public out of a means of informing legislators with real-world data, expertise, and perspectives they otherwise would not have access to is a problematic way to produce public policy. Clinicians, legal experts, and patient advocates, among many others, will be watching to see how this new rule is enforced.

[1] Clark, C. (2025, March 3). New HHS Rule Wipes Out Some Public Comment on Rulemaking. Retrieved from https://www.msn.com/en-us/politics/government/new-hhs-rule-wipes-out-some-public-comment-on-rulemaking/ar-AA1AaWmQ?ocid=socialshare

[2] McGrath, C. (2025, March 4). HHS overturns 54-year-old public comment rule. Healthcare Brew. Retrieved from https://www.healthcare-brew.com/stories/2025/03/04/hhs-overturns-54-year-old-public-comment-rule

[3] Policy on Adhering to the Text of the Administrative Procedure Act, 90 FR 11029 (proposed March 3, 2025). Retrieved from https://www.federalregister.gov/documents/2025/03/03/2025-03300/policy-on-adhering-to-the-text-of-the-administrative-procedure-act

[4] Pugh, T. (2025, March 5). RFK Jr.'s Limits on Rule Comments Have Risk for Medicaid, Grants. Retrieved from https://news.bloomberglaw.com/health-law-and-business/rfk-jr-s-limits-on-rule-comments-have-risk-for-medicaid-grants

[5] Ramirez, G., et. al. (2023, January 25). What is Lived Experience?. Office of Human Services Policy, U.S. Department of Health & Human Services. Retrieved from https://aspe.hhs.gov/reports/what-lived-experience.

[6] Young, S. (2025, January 15). Memorandum for the Heads of Executive Departments and Agencies. Office of Management and Budget, Executive Office of the President. Retrieved from https://www.whitehouse.gov/wp-content/uploads/2025/01/M-25-07-Broadening-Participation-and-Engagement.pdf

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.

Maryland and North Dakota Take Steps to Kick Their HIV Criminalizations Back to the 1980s

By: Ranier Simons, ADAP Blog Guest Contributor

HIV criminalization laws represent the worst of society’s response to the AIDS epidemic, rooted in fear, homophobia, and hysteria…and a lot of misinformation. The United States was the first nation to enact HIV-specific criminal laws, dating back to 1986-87. HIV criminalization laws still exist, but the wheels of progress are slowly chipping away at them as medical advances have changed HIV/AIDS from a death sentence to a manageable chronic disease. Equally important is the growing acceptance of the science behind “Undetectable Equals Untransmittable” (U=U), which has weakened the argument for these outdated, inhuman laws. Recently, two states, Maryland and North Dakota, passed bills to remove HIV criminalization laws from their statutes.

Photo Source: CHLP | The Marshall Project

Yet, many states still have active HIV criminalization laws in place. From 2008 to 2013, at least 180 people living with HIV/AIDS (PLWHA) were arrested or charged under HIV criminalization laws (Tang, 2024). These HIV statutes have not been updated to reflect evidence-based science and are predatory towards PLWHA. As of February 2025, 32 states have offenses that criminalize exposure to and/or transmission of HIV (CHLP, 2025). In 1994, Texas was the first state to repeal its HIV criminalization law (CHLP, 2020). The reality is that much work remains to kick HIV criminalization laws back to the 1980s, and some states are doing it!

In February of this year, Senate Bill 356 and House Bill 39 passed in both Maryland chambers. Both bills are repeals of a section of the Maryland code that specifically criminalized the intentional transfer of HIV from one person to another. The statute declared the knowing transmission of or attempted transmission of HIV a misdemeanor subject to a fine of up to $2,500 or a jail term with a maximum of three years, or both. Legislators passed the bills with the understanding that the law was not an effective means of protecting public health. Delegate Kris Fair stated (seen below), “The law was, for right or wrong, thought to help curb the transmission of HIV…What public health experts and criminal justice organizations have taught us … is that we’ve actually seen the exact opposite.” (Brown, 2025).

Photo Source: Maryland Matters | Photo by Danielle J. Brown

Also, on February 20, 2025, North Dakota passed House Bill 1217. This repeals a section of the code regarding the willful transfer of bodily fluid containing HIV. ‘Transfer’ here is defined as “engage in sexual activity by genital-genital contact, oral-genital contact, or anal-genital contact, or to permit the reuse of a hypodermic syringe, needle, or similar device without sterilization.” The law being repealed states that a person who knowingly transfers HIV to another person without their knowledge can be charged with a Class A felony with a maximum penalty of 20 years in prison and a maximum fine of $20,000. The bill changes the crime from a felony to a misdemeanor (Gall, 2025). In North Dakota, HIV is the only disease attributed to a felony charge, whereas other STI transmission crimes are misdemeanors. The bill now needs to be considered in the House.

Both states acknowledge that HIV criminalization is discriminatory. Singularly carving out HIV as a disease requiring enhanced criminal penalties increases stigma, is a disincentive for the public to normalize testing, and disproportionately affects specific populations. Fear of potential criminal prosecution means that people will be more hesitant to seek testing and subsequently must disclose their status to their partners (Yang, 2018). Additionally, it can adversely affect the trust within the doctor-patient relationship, resulting in delayed antiretroviral treatment initiation, poorer treatment outcomes, and adversely affecting public health. 

Medical science has made the possibility of HIV transmission effectively non-existent by PLWHA, who are undetectable on treatment. “U=U” is not a catchy slogan – it is an evidence-based scientific reality. Requiring an individual to indisputably prove their disclosure of their status if accused of exposure without consent is virtually impossible (Lazzarini, 2013). When HIV criminalization laws are in place, people can nefariously use them against people, such as a spurned partner retaliating against a former partner when a relationship does not end on good terms. Predatory laws harm PLWHA because being convicted does not even require actual HIV transmission to occur or proof of intent to deliberately pass the virus on to someone. 

Photo Source: Red Bubble

HIV criminalization laws also disproportionately affect marginalized groups, such as communities of color, specifically black men. Racial inequities and social determinants of health have already been shown to increase the likelihood of black male exposure to the criminal legal system (AIDS Vu, 2021). When HIV criminalization laws add enhanced sentencing or create violations that otherwise would not exist, they exacerbate targeted adverse outcomes. In Maryland, for example, Black people are 30% of the population, 71% of those who are PLWHA, and 82% of HIV-related criminal cases. Black men, specifically, are 68% of those accused in HIV-related cases despite comprising only 14% of the state population and 44% of Maryland PLWHA (UCLA, 2024).

Maryland and North Dakota’s recent bills to eliminate HIV criminalization are positive steps, but much more needs to be done. The number of states that currently have laws specifically targeting HIV for violations outside of standard communicable disease statutes or heightened sentencing is unacceptable. The stigma and hindrance to widespread testing of HIV criminalization add to the numerous barriers to ending the HIV epidemic in the United States. It would be easily conquerable if laws would catch up to science.

[1]  AIDSVu. (2021, May 10). HIV Criminalization. Retrieved from https://aidsvu.org/news-updates/hivcriminalization/#:~:text=HIV%20criminalization%20laws%20have%20also,transgender%20women%2C%20and%20sex%20workers.

[2] Brown, J. (2025, February 22). Bills to repeal ‘antiquated’ law criminalizing transfer of HIV sail through House, Senate. Retrieved from https://marylandmatters.org/2025/02/22/bills-to-repeal-antiquated-law-criminalizing-transfer-of-hiv-sail-through-house-senate

[3] The Center for HIV Law and Policy (CHLP). (2020). HIV CRIMINAL LAW REFORM: BEFORE & AFTER: Texas. Retrieved from https://www.hivlawandpolicy.org/sites/default/files/HIV%20Criminal%20Law%20Reform%20Before%20and%20After%20Texas%2C%20CHLP%202020.pdf

[4] The Center for HIV Law and Policy (CHLP). (February, 2025). Mapping HIV Criminalization Laws in the U.S. Retrieved from https://www.hivlawandpolicy.org/sites/default/files/2025-02/Mapping%20HIV%20Criminalization%20Laws%20in%20the%20US%2C%20CHLP%202025.pdf

[5] Gall, P. (2025, February 20). House Bill to reduce HIV transmission penalty advances in North Dakota. Retrieved from https://www.ksjbam.com/2025/02/20/intentional-hiv-transmission-charge-may-be-lowered-from-felony-to-misdemeanor/#:~:text=House%20Bill%201217%20passed%20on,to%20the%20Senate%20for%20consideration.

[6] Lazzarini, Z., Galletly, C. L., Mykhalovskiy, E., Harsono, D., O'Keefe, E., Singer, M., & Levine, R. J. (2013). Criminalization of HIV transmission and exposure: research and policy agenda. American Journal of Public Health, 103(8), 1350–1353. https://doi.org/10.2105/AJPH.2013.301267

[7] UCLA School of Law Williams Institute. (2024, January). Enforcement of HIV Criminalization in Maryland. Retrieved from https://williamsinstitute.law.ucla.edu/wp-content/uploads/HIV-Criminalization-MD-Jan-2024.pdf

[8] Tang, Catherine (2024). Our country's dark history of persecuting people with HIV. HIV Plus Magazine. Retrieved from https://www.hivplusmag.com/stigma/us-history-hiv-criminalization.

[9] Yang, Y. T., & Underhill, K. (2018). Rethinking Criminalization of HIV Exposure — Lessons from California’s New Legislation. New England Journal of Medicine, 378(13), 1174–1175. https://doi.org/10.1056/nejmp1716981

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. 

IRA Spelling Trouble for Community Pharmacies, and Patient Access Could be Next

By: Ranier Simons, ADAP Blog Guest Contributor

The Inflation Reduction Act of 2022 (IRA) contains multifaceted goals to improve healthcare access and lower healthcare costs, including prescription drug costs (CMS, 2025). The Medicare Drug Price Negotiation program is one such initiative, according to the Centers for Medicare and Medicaid Services (CMS). This initiative authorizes Medicare to directly negotiate the price of prescription drugs with manufacturers for outpatient drugs under Medicare Part D and later for physician-administered drugs under Part B. The initial ten drugs identified for “negotiation” have already been selected, and their new pricing will go into effect in 2026 under what has been termed the Maximum Fair Price (MFP). Whether the IRA’s lofty goals – such as lowering patient drug costs and lowering insurance premiums – are successful remains questionable. However, community pharmacies are already being adversely impacted by the new, untested pricing scheme, which could spill over and cause harm to patients. The National Community Pharmacists Association (NCPA) recently released an analysis of the MFP’s potential unintended effects on pharmacies' financial stability and cash flow (NCPA, 2025). The picture is bleak. 

Photo Source: NCPA

Implementing the MFP is a departure from the current status quo of pharmacy reimbursement. Presently, pharmacies purchase drugs, pay their acquisition cost, and are subsequently reimbursed by PBMs after filing their claim. The drugs on the MFP list require a different payment mechanism. The MFP program requires payment from PBMs and refunds from manufacturers. In general, PBMs will reimburse pharmacies an amount equal to the MFP, and then manufacturers will be required to reimburse pharmacies for the difference between the acquisition price and the MFP (NCPA, 2025). The mechanisms for implementation and the amounts paid are the sources of cash flow concern for pharmacies.

The MFP payments will be made utilizing a system in development called the Medicare Transition Facilitator (MTF) (NCPA, 2025). It will have two parts, the MTF Data Module (MTF DM) and the MTF Payment Module (MTF PM). All parties must enroll in the MTF DM to ensure compliance with open data exchange for expedient application of negotiated prices. The MTF PM is optional for manufacturers who can make refund payments via it or by another means of their choosing. The time delay in reimbursement payments for both the PBM payment and the manufacturer refund is an issue.

NCPA’s analysis of historical payment data indicates that PBMs currently reimburse pharmacies around 14 days after a claim is filed (NCPA, 2025). They constructed a payment model of cash flow, indicating the new MTF PM approach would add a delay to completed reimbursement. NCPA anticipates that, on average, manufacturers would refund pharmacies around one week after PBMs submitted reimbursement. This would mean pharmacies would have less cash for operating expenses while waiting for full reimbursement. The PBM payment would theoretically be equal to the MFP, which is a significant discount on the acquisition cost, on average 60 percent (NCPA, 2025). Thus, a pharmacy would have to function with a cash flow deficit until the manufacturer’s refund was paid, potentially making them whole regarding what they paid to acquire the drug. Moreover, this leads to potential issues of reimbursement amounts.

Photo Source: Lagniappe Pharmacy

Under the status quo, pharmacies already deal with issues of under-reimbursement. There is potential for additional harm under an MFP scenario. Presently the NCPA found that pharmacies are operating with small margins of profit. Under the MFP framework, pharmacies could bring even less revenue (NCPA, 2025). Currently, pharmacies operate profitably with payments higher than their acquisition costs. Under the MFP PM system, profit due to pricing differential is lowered or eliminated. Additionally, the MFP is the maximum possible PBM reimbursement. There is a possibility that PBM reimbursement may be lower than the MFP (NCPA, 2025). Thus, pharmacies could end up at a loss when net reimbursement is the difference between the acquisition cost and the sum of the PBM reimbursement and manufacturer refund.

Patients’ access to medications could be harmed if pharmacies close due to their inability to operate under financial losses. Additionally, NCPA posits that pharmacies associated with 340B Covered Entities could be adversely affected. Their model, which assumes an operational average of 15 fills of MFP medications per week, would equal a typical annual loss of revenue in the range of $240,060.60 to $ 433,633.20 (NCPA, 2025). Losses on this level would mean termination or significant scaling back of services for vulnerable populations that 340 B Covered Entities serve. NCPA also emphasizes in their reporting that the MFP does not mandate a dispensing fee, nor does any IRA document indicate any dispensing fee guidance (NCPA, 2025).

The NCPA based its analysis and modeling on available data of historical Medicare prescription drug data. However, the inferences made could be drastically different once the MFP PM approach is put into effect. Delays in payments from PBMs and manufacturers could be longer than expected, leading to even greater financial instability due to a poorer influx of cash flow. Terms between wholesalers and pharmacies could change further, negatively affecting pharmacy reimbursement levels. There is the theoretical possibility of improvements in revenues for pharmacies where the MFP manufacture refund would be more than they usually receive for reimbursement. However, this is not what NCPAs analysis indicates as a widespread possibility (NCPA, 2025). The end result is patients unable to access the medications they need.

Photo Source: ConsumerMedSafety.org

The bottom line is that while well-intentioned, the MFP could have a host of unexpected negative potential outcomes. Many details of the MTF have not been completely fleshed out. Moreover, NCPA analysis indicates that the amount of potential financial loss increases as the volume of a pharmacy’s MFP-associated drug prescription fills increases (NCPA, 2025). Being engaged with the continued development of the MTF-DM and MTF-PM is crucial to ensure that policymakers do not end up codifying effectuating harm.

[1] CMS. (2025, January 20). Inflation Reduction Act and Medicare. Retrieved from https://www.cms.gov/inflation-reduction-act-and-medicare#:~:text=People%20with%20Medicare%20will%20benefit,Changes%20to%20Medicare%20Part%20B

[2] National Community Pharmacists Association (NCPA). (2025, January). Analysis on Pharmacy Cash Flows. Retrieved from https://ncpa.org/sites/default/files/2025-01/January2025-ThreeAxisAdvisors-Unpacking-the-Financial-Impacts-of-Medicare-Drug-Price-Negotiation.pdf

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. 

340B Paradigm Shift: New Rebate Model Puts Patients First, Not Providers

By: Ranier Simons, ADAP Blog Guest Contributor

Since its inception in 1992 up until 2010, patients were generally thought to have benefited from the 340B Drug Pricing Program. That perception began to change with the passage of the Affordable Care Act (ACA), however. Although the expansion of the 340B program was supposed to have worked hand in glove with the ACA to expand the provision of affordable health care to the underinsured and uninsured, the 340B program, post-ACA, was accompanied by new challenges that have remained largely unchecked over the subsequent 15 years. The result is a program that has veered from its intended purpose. This is evidenced by explosive growth in the number of healthcare providers, or covered entities, participating in the program, while 340B hospitals have actually reduced the charity care they offer to needy patients. The total value, at list price, of the purchases made under the program now exceeds $124 billion (Fein, May 2024), even as medical debt in the United States has soared to $220 billion (Rakshit, February 2024). An IQVIA study demonstrated that only 1.4% of 340B patients receiving 340B drugs through contract pharmacies had any assistance with their out-of-pocket costs at the pharmacy counter. But the growing chorus calling for reform of the 340B Program now includes a new idea: 340B pricing made available through rebates instead of upfront payments. Patients are beginning to ask if it is an idea that could benefit them?

Photo Source: Healthcare Dive

In August 2024, Johnson & Johnson Health Care Systems, Inc (JJHCS) announced its 340B rebate model (J&J, Aug 2024). The new model was an attempt to correct some of the improper utilization of the 340B program and ensure that patients received direct benefits from the savings. Instead of the most prevalent chargeback model, JJHCS decided to offer Stelara and Xarelto to disproportionate share hospital (DSH) covered entities via rebate (J&J, Aug 2024). All other 340B eligible entities would remain on the standard chargeback model. DSH-covered entities would be required to purchase the two drugs from wholesalers at the commercial non-discounted price and then submit a rebate claim for the 340B discount. After the claims are validated, the rebates would be deposited into the bank accounts of the DSH-covered entity. This arrangement applied regardless of whether the medication was dispensed through an in-house pharmacy or contract pharmacy.

Stelara and Xarelto are high-volume, expensive medications. Offering the 340B rebate on these two medications would provide significant savings for a large patient base and their providers, and it would also affect JJHCS’s financial bottom line. The rebate would be calculated as a Wholesale Acquisition Cost (WAC) 340B ceiling price even if a 340B DSH hospital has an agreement with a wholesaler for a lower price (J&J Innovative Medicine, 2024). The rebate concept is not novel. Kalderos, a data infrastructure and analytics company, presented a similar ideology in 2020 based on a discount drug payment platform of their own creation. Their research showed that converted entities benefited from higher revenues when rebates were based on WAC as opposed to contract pharmacy reimbursement tied to discounted Average Wholesale Price (AWP) (Fein, 2022).

HRSA responded to JJHCS unfavorably, even though the 340B statute requires HRSA to “provide for ‘any rebate or discount’ in accounting for the “amount required to be paid” under the program. HRSA nevertheless claimed that JJHCS’ proposed 340B rebate model violates the 340B statute. The agency’s interpretation of the law is that the rebate model’s requirement that a covered entity pay a commercial price upfront and then receive a rebate thereafter (even though payment is promised in “no more than seven to ten days”) violates the statute because the initial price is higher than the statutory ceiling price. Additionally, HRSA claims that it has the authority to approve any proposed rebate or other models before they are allowed to go into effect, even though it has never done so for any model employed over the 33 years that the program has been in effect. 

In contrast, JJHCS contends that the 340B rebate plan is like the rebate processes that AIDS Drug Assistance Programs (ADAPs) use and the replenishment model that most 340B covered entities use. 

In October 2024, Bristol-Myers Squibb (BMS) informed HRSA that it would also start using a 340B rebate model, and it was met with the same resistance by the agency. Despite some patient advocates arguing the BMS model is explicitly pro-patient, in that it offers “even faster” rebate payments if the covered entity “agrees to share” 340B pricing with the patient. The BMS model provides a real opportunity to encourage covered entities to live up to the original intent of the program by providing a direct benefit to patients at the pharmacy counter. 

HRSA has informed both JJHCS, BMS, and other manufacturers proposing rebate models that it will take significant enforcement action if they proceed. The threats of enforcement action were particularly sharp concerning Johnson & Johnson Health Care Systems. In that case, HRSA stated that implementation of the rebate would result in civil monetary penalties as well as termination of the company’s Pharmaceutical Pricing Agreement (PPA). A termination would mean that any affected manufacturer would not be able to participate in not just the 340B program but would also lose Medicare Part D and Medicaid coverage for all its products, cutting off potentially millions of patients from the drugs on which they are dependent for their health and safety. 

JJHCS, BMS, and multiple other manufacturers filed suit against HRSA arguing that the rebate model is explicitly permitted by statute. ADAP Advocacy and CF United jointly filed an amicus brief in support of the JJHCS lawsuit and BMS lawsuit (ADAP & CF, 2025). They were the first two patient advocacy groups to do so.

Photo Source: ADAP Advocacy

Amanda Boone, co-founder of CF United, a patient advocacy group representing people living with cystic fibrosis and other rare diseases, said, “Our patient organization, CF United, decided to file an amicus brief in support of this issue because the experiences of cystic fibrosis patients and other rare disease communities illustrate the urgent need for reform. The current system leaves many of us—who are already battling life-threatening conditions—burdened with insurmountable medical debt, often without being informed of available financial assistance.” Boone is a member of ADAP Advocacy’s patient working group focused on 340B reform.

The amicus brief supports the JJHCA and BMS lawsuits by adding needed color to the complaint from a patient perspective and highlighting additional issues for the court’s consideration. First, the amicus brief explains that manufacturers have a right to utilize the 340B rebate model under the statute (ADAP & CF, 2025). The statute does not specify a mode of 340B reimbursement. Nor does the statute give HRSA any “pre-approval” authority to solely and exclusively decide whether a particular rebate model is valid. The brief explains that assuming such authority is wholly inconsistent with the plain language of the statute and HRSA’s implementation of the program to date.

Second, the brief explores how some covered entities, particularly the large, highly resourced hospitals that receive up to 80% of the billions in profits from the program, serve their economic interests at the expense of patients at the pharmacy counter. According to the factual background provided in the brief, 340B program purchases increased by 1,000% from 2011 to 2022, but charity care decreased from 2.60% to 2.15% (ADAP & CF, 2025). Most egregiously, many 340B hospitals, even as they are making millions from the program, pursue aggressive collections against poor patients without offering any charity care to those in need (ADAP & CF, 2025). The 340B rebate model, particularly as BMS has proposed it, enables transparency that can and should benefit patients. BMS’ model ensures that 340B purchases are legitimate, directs the rebate to the proper entities, and helps encourage low-cost pricing to be shared directly with patients.

Third, the amicus briefs express serious concerns about HRSA’s threat to remove JJHCS’s PPA because of the far-reaching adverse effects it would have on patients. William Sarraille, ADAP Advocacy’s Special Counsel on issues related to the 340B Drug Pricing Program, explains, “HRSA’s threat to remove manufacturers from the 340B program—and thereby cut off Medicare and Medicaid patient access to their drug therapies—was a recklessly anti-patient act. Sadly, it showed that HRSA cares more about protecting covered entities that engage in diversion, duplicate discounts, and that fail to share 340B pricing with patients than it does about patient access to desperately needed medications.” Sarraille adds, “HRSA could have insisted on certain safeguards in helping to adapt the rebate model for such covered entities as clinics serving HIV and AIDS patients, but it was willing, under lobbyist pressure, to put patients at risk in a blanket refusal to entertain any additional transparency.”

Community Access National Network’s President & CEO, Jen Laws, added, “HRSA has had 30 years to figure itself out in terms of correcting some of the misaligned incentives of the 340B program. Indeed, as recently as the passing of the Inflation Reduction Act, HRSA got the nudge from federal legislators to figure it out. The agency has simply refused to do so.” CANN was the first patient advocacy organization in the HIV space to express support for the new rebate model so long as protections existed for Grantees.

Laws’ reference to the Inflation Reduction Act’s (IRA) drug price negotiation program is, in fact, part of the impetus for the litigation. Under rules established to implement the IRA, drug manufacturers are responsible for ensuring duplicate IRA and 340B discounts are not applied.  Without a rebate model, manufacturers will inevitably pay those duplicates, contrary to the IRA. 

“You can’t just say, ‘Well, good luck figuring it out’ and then disempower any ability to audit claims”, Laws commented. “HRSA doesn’t have the capacity and covered entities, PBMs, and third-party administrators have refused to do so”, he added.  “If you’ve got nothing to hide, this shouldn’t be such a big deal.” Laws argued that it is always CANN’s preference for policy issues to be hammered out by policymakers as opposed to judges with what amounts to ‘downloaded expertise’, either by litigation or legislation. “We support 340B reform. Adjusting payment models to empower manufacturers to ensure their dollars meant to benefit patients actually are benefiting patients is simply good stewardship of the program. It’s a damned shame HRSA can’t get on board with that,” he added.

Photo Source: CANN

In general, hospitals oppose the 340B rebate model. They purport that the rebate model would cause financially damaging delays in recouping rebates, would place manufacturers in charge of 340B pricing, instead of HRSA, and would overburden hospitals with bureaucratic red tape (Freedman et al., 2024). Conversely, manufacturers point out that their rebate system increases transparency, provides for prompt payment, upon validation of a claim, within 7-10 days (faster than covered entities are required to pay wholesalers), and involves only the submission of data that covered entities already are required to collect and maintain. Additionally, the platform for execution is free (J&J, Aug 2024). Ryan White clinics oppose the model out of concern for the upfront financial expenditure, but are, at least at this point, carved out of several of the proposed models, including the JJHCS model, which is limited to disproportionate share hospitals.

In filing its amicus brief in support of the manufacturers' new rebate model, ADAP Advocacy noted because of the difference between 340B hospitals and some covered entities, like clinics serving clients living with HIV, it appreciates that, in deploying rebate mechanisms, steps have been taken to carve out some 340B clinic types. 

The 340B rebate program has evolved far from its narrowly focused beginnings. Instead of being patient-focused, directly benefiting the vulnerable populations it was meant for, it has become a runaway cash cow for those knowledgeable enough to game the system and willing to put their interests above their patients. Various 340B rebate policy proposals aim to make sure rebate revenues flow in the manner they were originally meant. Patients deserve better, and the country continues to suffer excessive medical and fiscal expenditures due to 340B abuse. All eyes will be watching the outcomes of these and future 340B lawsuits.

[1] ADAP Advocacy, CF United. (2025, February 10). Motion for Leave by Amici Curiae, CF United, and ADAP Advocacy. Retrieved from https://www.adapadvocacy.org/urls/DC_Dist_Court_Johnson-Johnson_v_Dorthy-Fink_DHHS_Diana-Espinosa_HRSA_02-10-25.pdf

[2] Fein, A. J., PhD. (2022, January 14). The 340B rebate model: a solution to the contract pharmacy controversy. https://www.drugchannels.net/2022/01/the-340b-rebate-model-solution-to.html

[3] Freedman, L., Hardy, X., Santiago, A. (2024, November 12). Unpacking Johnson & Johnson’s Lawsuit Over 340B Rebate Model. Retrieved fromhttps://www.mintz.com/insights-center/viewpoints/2146/2024-11-19-unpacking-johnson-johnsons-lawsuit-over-340b-rebate#:~:text=The%20announcement%20of%20the%20rebate,protect%E2%80%9D%20the%20DSH%20covered%20entities.

[4] Johnson, Carole. (2024, September 17). Letter to JJHCS. Retrieved from https://340breport.com/wp-content/uploads/2024/09/HHS-letter-to-JJ-09.17.2024.pd

[5] Johnson & Johnson. (2024, August 23). Notice to 340B End Customers Regarding Purchases of STELARA and XARELTO. Retrieved from https://sponsors.aha.org/rs/710-ZLL-651/images/Johnson%20%20Johnson%20Innovative%20Medicine%20340B%20Rebate%20Model%20Policy%20Update%2008-23-2024_FINAL.pdf?version=0

[6] Johnson & Johnson Innovative Medicine. (2024).12 things to know about J&J’s 340B Rebate Model Policy. Retrieved from https://transparencyreport.janssen.com/12-things-to-know-about-j-js-340b-rebate-model-policy#:~:text=340B%20rebates%20will%20be%20paid,”%20until%20January%201%2C%202026.&text=J&J's%20rebate%20model%20requires%20industry,purchase%20and%20the%20product%20dispense.

[7] Rajan, G., Coates, S. (2024, November 15). Lilly sues US agency over blocking of drug-rebate program. Retrieved fromhttps://www.reuters.com/legal/lilly-sues-us-agency-over-blocking-drug-rebate-program-2024-11-15/#:~:text=Eli%20Lilly%20said%20its%20program,Sign%20up%20here. 

[8] White, S. (2024, September 30). Letter to HRSA. Retrieved from /https://transparencyreport.janssen.com/letter-in-response-to-hrs

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.