HRSA Mired in Uncertainty, Instability, and Confusion; Patient Advocates Increasingly Concerned

By: Ranier Simons, ADAP Blog Guest Contributor

The Trump Administration's developing policies regarding population health and well-being continue to propagate uncertainty, instability, and confusion amidst entities that affect optimal health outcomes for all citizens. Notably, there is a concerted effort to dismantle infrastructure instituted by previous administrations that made the Ryan White HIV/AIDS Program (RWHAP) and other federal health programs more inclusive of the needs of marginalized communities. A recent Special Bulletin sent out by the Health Resources and Services Administration’s (HRSA) HIV/AIDS Bureau (HAB) does not immediately effect change. Yet, some stakeholders are concerned about its possible implications (Engels, 2025). But numerous things unfolding simultaneously have yielded chaos.

Photo Source: CNS photo/Nancy Phelan Wiechec

The HRSA HAB special bulletin contained a 'Dear Colleague' letter from HRSA Administrator Thomas J. Engels addressed to RWHAP program awardees and stakeholders, which includes many national partners and federal colleagues. The letter began by extolling the virtues and successes of RWHAP and how it is a lifeline for people living with HIV/AIDS (PLWHA). It then proceeded to criticize RWHAP policies under the Biden administration. The letter states, “…under the previous administration, certain interpretations of RWHAP’s allowable uses, as outlined in prior communications, co-opted the program’s patient-centered mission in favor of radical ideological agendas and policies. Congress envisioned RWHAP as a lifeline for those battling HIV and AIDS, not as a vehicle for broader social or medical experimentation. More to the point, this politicized commandeering risks diverting resources away from HIV/AIDS patients, whose lives depend on RWHAP’s core medical services.” (Engels, 2025)

The letter contained a direct footnote in reference to what it described as ‘radical ideological agendas and policies’ (Engles, 202). The footnote was guidance from the U.S. Department of Health and Human Services (HHS) from December 2021, stating that RWHAP funds could be used to support gender-affirming care through RWHAP core medical and support service categories (Cheever, 2021). The 2021 guidance defined the appropriate services as those outlined in Policy Clarification Notice #16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals & Allowable Uses of Funds (PCN# 16-02).

Some State AIDS Drug Assistance Programs (ADAP) have gender-affirming hormone therapy as part of their formulary. Holistic treatment of transgender individuals living with HIV also includes services such as mental health counseling for gender dysphoria, substance use disorder treatment, and even housing and case management services. These services are necessary to support anti-retroviral treatment adherence and positive HIV-related healthcare outcomes in transgender individuals, hence why the Biden administration issued the policy guidance (Cheever, 2021).

After the direct reference to transgender HIV care as a radical policy, the Special Bulletin further adds, “…HAB reaffirms that RWHAP funds shall be marshaled exclusively toward evidence-based interventions proven to combat HIV, sustain viral suppression, and improve the quality of life for those living with the disease.” It defines those as outpatient care and support services, including but not limited to providing HIV medications and housing assistance. Interestingly, the letter emphasizes that RWHAP funds are not authorized for things outside of the scope of PCN# 16-02, the same notice utilized by the Biden administration’s 2021 policy guidance, including affirming gender-affirming care under RWHAP (Engels, 2025).

Photo Source: The New York Times

Specifically highlighting gender-affirming care with the implication that it is radical and not authorized, utilizing guidance that defined it as appropriate, essentially to say it is not appropriate, is contradictory and nebulous. The Dear Colleague letter is not a policy implementation, yet it leaves enough doubt for many RWHAP recipients to be concerned about the services they are providing. According to 2021 data, 11,600, or 2.1 percent of RWHAP patients, are transgender (Cheever, 2025). That is a large population of vulnerable individuals potentially losing certain needed services.

The present HRSA RWHAP messaging emphasis on gender-affirming care is in alignment with the Trump Administration’s delegitimization of transgender lives and transgender health. Presently, the administration is appealing a block on its desired ban of openly transgender service members in the military (Pierson, 2025). The administration’s attorneys argue circularly that the ban is not based on transgender identity but on the medical condition of gender dysphoria. They purport that those who identify as transgender can still serve if they do not have gender dysphoria or openly live as a sex different than their sex at birth. 

The Centers for Medicare and Medicaid Services (CMS) issued a letter on April 11, 2025, addressed to state Medicaid Directors, urging states not to use Medicaid funds for gender-affirming care for minors, highlighting hormone treatments, puberty blockers, or surgeries (Snyder, 2025). The letter refutes the legitimacy of gender-affirming care for minors. It further adds that “State Medicaid programs have a responsibility to ensure that payments are consistent with 'efficiency, economy, and quality of care' under Section 1902(a)(30)(A) of the Social Security Act…CMS is committed to following the highest standards of care and adhering closely to the foundational principles of medicine, especially when it comes to doing no harm to America’s children.”

Additional alarm stems from the HHS FY2026 discretionary "budget passback" that was leaked last week. The budget passback is a draft document that gives an informed look at the priorities of the Trump Administration’s Office of Management and Budget (OMB) as it prepares a budget request for Congress. The Washington Post reported that while Congress typically ignores the President's budget request, given that the current political environment is not typical, it’s important to investigate its drastic transformative blueprint (Sun et al., 2025).

Source: The Washington Post

ADAP Advocacy contacted Tim Horn, Director of Medication Access for NASTAD, for insight on the 64-page documents' details associated with infectious disease programs. The leaked budget proposal includes provisions to formally eliminate the CDC’s Division of HIV Prevention, Ending the HIV Epidemic (EHE) funding across the government, all funding for Part F of the Ryan White/HIV AIDS Program, Minority AIDS Initiative Funding, and a significant amount of SAMHSA Substance Abuse Treatment Programs of National and Regional Significance (PRNS). The Washington Post also highlights that the proposal cuts the NIH budget by 40 percent, eliminating entities like the NIH National Institute on Minority Health and Health Disparities (Sun et. al, 2025).

Although the current flurry of activity is causing RWHAP great unease, Jen Laws, CEO of Community Access Action Network (CANN), offers insight for the immediate present. Concerning the HRSA Special Bulletin, he shared, “A ‘special bulletin’ is not formal guidance or policy of any kind. That would most assuredly constitute a final agency action and open the door to either adding this issue to existing suits regarding public health funding programs or a suit on its own. Here, RWHAP sub-recipients need to know that this is not binding guidance and that their service offerings should not be changed. Rather, it's a flag, a signal, if you will, on what the Administration intends to do.”

Ongoing RWHAP stakeholder stress is further exacerbated by the breakdown in infrastructural support offered to them. For example, HRSA abruptly cancelled the HAB National Partners meeting initially scheduled for April 14, 2025, without any explanation or details about rescheduling it. One provider stakeholder, speaking to ADAP Advocacy on the condition of anonymity, decried, "We're feeling very devalued and simply bracing ourselves for the other shoe to drop."

Vigilance is imperative in monitoring HRSA's navigation through the current administration's actions and possible changes to Medicaid. The lives of PLWHA and other marginalized communities and the health of the general population are at stake. Distinguishing enforceable actions from propagandized smoke screens will help maintain hope and enable sustained focus on targeted response.

[1] Cheever, L. (2021, December 2021). Dear Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/hiv-care/gender-affirming-care-rwhap.pdf

[2] Engels, T. (2025, April 7). Dear Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/about-program/letter-grantees-rwhap-4-2025.pdf

[3] Pierson, B. (2025, April 22). Trump administration pushes appeals court to enforce military's transgender ban. Retrieved from https://www.reuters.com/legal/government/trump-administration-pushes-appeals-court-enforce-militarys-transgender-ban-2025-04-22/

[4] Snyder, D. (2025, April 11). CMS Letter to State Medicaid Directors. Retrieved from https://www.cms.gov/files/document/letter-stm.pdf

[5] Sun, L., Johnson, C., Roubein, R., Achenbach, J., Weber,L. (2025, April 16). Internal budget document reveals extent of Trump’s proposed health cuts. Retrieved from https://www.washingtonpost.com/health/2025/04/16/hhs-budget-cut-trump/

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. 

Despite Ongoing Chaos, Ryan White Program 2030 Plan Remains Relevant

By: Ranier Simons, ADAP Blog Guest Contributor

In December 2024, Ryan White HIV/AIDS Program (RWHAP) partners received a guidance letter about the Ryan White Program 2030 plan (RWP 2030) from the Health Resources Services Administration (HRSA). The guidance, in the form of a Dear Colleague Letter (DCL) did not include specific policy explanations or detailed implementation instructions, but rathe highlights of directives and unifying paradigms of action. Given the current political climate and the state of flux regarding public health programs and access to public health data on federal agency websites this letter might now be undermined. That said, it is also an acknowledgment of past successes and how they relate to future targets.

(Editor's Note: Some of the links included in the Dear Colleague Letter have already been scrubbed from their websites)

RWP 2030 maintains a focus on an efficacious, high standard of care for those presently benefiting from programs and services through the Ryan White HIV/AIDS Program (RWHAP). The DCL emphasizes the importance of increased efforts to find people living with HIV/AIDS (PLWHA) who are undiagnosed or who have fallen out of the care continuum and bring them into proper care. Data from August of 2024 indicates that 13 percent of the 1.2 million PLWHA in the U.S. are undiagnosed and unaware (HIV.GOV, 2024). That is roughly 156,000 individuals in danger of serious adverse health outcomes due to lack of treatment as well as the potential to unknowingly spread HIV. A combined 40 percent of PLWHA in the U.S. are undiagnosed or diagnosed and not receiving care. 

Great strides have been made regarding viral suppression, and a renewed focus on reaching untreated individuals is the RWP 2030’s aim to increase those numbers. From 2010 to 2023, viral suppression amongst those receiving care under the RWHAP increased from 69.5% to 90.6% (HRSA, 2024). Viral suppression does not happen overnight and is not a permanent self-maintaining endpoint. Reaching viral suppression requires consistent care, and maintaining it requires permanent care.

Source: HIV.gov

The DCL stresses the need for community-driven collaboration and planning. PLWHA live in populations and communities of significant heterogeneity. The RWP 2030 aims to equip people and entities with the resources, capacity-building tools, and training to create the infrastructures needed to meet the specific needs of identified communities. The letter states that success will require “collaboration across sectors, innovation in care delivery, and a commitment to addressing barriers to care” (HRSA, 2024). 

The RWP 2030 framework of leveraging partnerships, focusing interventions, and community engagement is the most effective mindset to have going forward (HRSA, 2024). Presently, there is much uncertainty concerning funding, policy, and potentially adverse effects of political expediency. The DCL reminds RWHAP recipients of the importance of being vigilant with the reevaluation of programs and services to maximize the allocation of efforts to meet locally identified needs. Monitoring is imperative to balance furthering the appropriate care of those already receiving RWHAP services and engaging people new and returning to care.

HRSA plans to release specific guidance and development of tools to support RWHAP recipients in realizing RWP 2030 goals. Some of the education on best practices for outreach, linkage to, and engagement in care is not available as many HIV resources, such as TargetHIV.org, are not available, having been removed from online access by the current administration as of the time of this blog. This fortifies the need for innovative measures of collaboration and the inclusion of non-traditional partnerships to strengthen infrastructures of care. In addition to training and resources, HRSA plans to hold a series of listening sessions in 2025 (HRSA, 2024). The goal is to facilitate exposure to a diverse range of perspectives and experiences associated with navigating the hurdles and pitfalls on the journey of ending the HIV epidemic.

Photo Source: HRSA HIV/AIDS Bureau

Program letters are not only a press statement or documentation for the purposes of public record. HRSA DCLs are a source of information, motivation, hope, and reassurance that RWHAP recipients are supported and are not isolated islands. Reminding entities of their mission and identifying the means to find the help they need is vital for programmatic success. How this plan plays out under the ongoing attacks on public health programs still remains to be seen.

[1] HRSA. (2024, December 20). Dear Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/rw-program-letter-2030.pdf

[2] HIV.GOV. (2024, August 15). U, S. Statistics. Retrieved from https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics#:~:text=Approximately%201.2%20million%20people%20in,sex%20with%20men%20(MSM)

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. 

Courts Put Guardrails on 340B Program, Aiding Reform Efforts to Ebb Abuse

By: Ranier Simons, ADAP Blog Guest Contributor

Since 1992, the 340B Drug Pricing Program has enabled eligible health care providers, referred to as covered entities, “to stretch scarce federal resources to reach more eligible patients or provide more comprehensive services.”[1] One of the most notable characteristics of the program is that it is not funded by the government. Since it requires drug manufacturers to sell medications to eligible entities at steep discounts, in essence, it is a legally mandated reallocation of financial resources from private industry to providers. As such, abuses of the program are especially egregious. The vast growth of the 340B Program over time has led to increased abuses in it as big hospital systems and mega service providers sought to enhance their profits over serving vulnerable patient populations. A tug-of-war among varied interests has generated many legal challenges in attempts at 340B reform. Recently, the pharmaceutical industry has achieved wins in its favor.

Photo Source: PharmaLive | Biospace

In May of this year, D.C. Circuit Court of Appeals ruled in favor of Novartis and United Therapeutics. Both companies separately sued the Health Resources and Services Administration (HRSA), which is the federal agency charged with overseeing the program. HRSA sent oversight enforcement letters stating the pharmaceutical manufacturers were in violation of the 340B statute because they imposed new restrictions on covered entities and limited their number of contract pharmacies.[2] The manufacturers had issued conditions on the usage of contract pharmacies 340B qualified entities utilized to purchase drugs they sold. Some of the conditions included requiring covered entities with in-house pharmacies to use those pharmacies to dispense 340B drugs and limiting entities without in-house pharmacies to only one contract pharmacy.[2]

HRSA claimed that the 340B statute allowed covered entities to utilize an unlimited number of contract pharmacies; thus, drug manufacturers were mandated to ship 340B drugs to wherever entities wanted. They issued enforcement letters threatening civil monetary penalties due to non-compliance.[2] The D.C. Circuit consolidated both companies' cases and ruled that the 340B statute did not explicitly forbid manufacturers from imposing conditions on the distribution of covered drugs to covered entities.[2] Additionally, the court quashed HRSA’s enforcement letters, stating that they were arbitrary and capricious under the Administrative Procedure Act (APA).[2] Thus, the manufacturers can continue to impose conditions.

Pharmaceutical companies have instituted conditions on contract pharmacies as one way to fight against abuses of the 340B program. Mounting evidence has demonstrated too many bad actors are taking advantage of the program, increasing profit instead of using the proceeds to benefit patients. Some hospitals have purchased 340B drugs and then sold them at full price or more to affluent, fully insured patients as well as uninsured patients.[3] This harms uninsured and vulnerable populations, cutting access when they cannot afford the pricing instead of helping those the program was meant to help. Another abuse is entities prescribing higher-cost medications when effective lower-cost drugs are available for the sole purpose of maximizing profit from the 340B discount spread.[4] Abuses like these are possible because the law in its present state does not specify drug discounts remain reserved only for those who are needy.[3] This is why manufacturers are trying to limit distribution to entities and pharmacies directly benefiting needy patients.

Photo Source: Fierce Healthcare

There is fierce opposition to the growing chorus calling for reforms to the 340B Program, that is actually anti-reform. Those fighting against 340B reform posit that those in support of 340B reform are attempting to gut the program and save themselves money by reducing the number of drugs they are discounting. The reality is the anti-reform movement is more concerned over what is seemingly an unlimited ATM with few strings attached, if any. For example, the American Hospital Association wrote a letter against H.R. 8574, the 340B Affording Care for Communities and Ensuring a Strong Safety-net (340B ACCESS) Act.[5] The act does several things, including creating updated eligibility requirements ensuring that authentic safety-net providers serving needy, underserved populations are the only entities benefiting from the program. It also establishes that federal grantees and their contract pharmacies must provide affordability assistance policies that ensure patients are not denied access to 340B medicines based on their ability to pay.[6]

The well-resourced forces who are against 340B reform are against it because reform prevents them from utilizing the 340B Program revenues as cash flows to expand services, acquire practices, and engage in other ventures that are not focused on safety-net population medical care. In June of this year, a study conducted as a combined effort of Appalachian Learning Initiative, ADAP Advocacy, and Community Access National Network highlights how large organizations use 340B funds.[7] The full text of the report can be found, here. 

One of the most notable findings involves CEO compensation. The study examined data on the entities studied, showing changes in activity before and after obtaining 340B eligibility. It was found that executive compensation increased by an average of 231.51%, and the provision of charity care as a percentage of annual hospital revenues decreased by 14.79%.[7] Additionally, they found that the overall yearly revenues of the entities studied increased by an average of 824.32%.[7] This would indicate that as revenues increased, the level of spending on charity care decreased. Charity care is not the only avenue available to covered entities to support their poor and underserved populations. However, if the purpose of the 340B program is to generate revenues to help those in need, one would expect to see an increase in charity care.

Photo Source: Drug Channels Institute | iStock Photos

The recent court ruling by the D.C. Court of Appeals, and other ones, is finally putting some guardrails on the 340B Program, which has ballooned to a record $66.3 billion in 2023.[8] In his recent analysis of the program’s growth, Dr. Adam J. Fein with the Drug Channels Institute summarized, “Lobbyists claim that manufacturers’ 340B contract pharmacy changes are 'stripping billions of dollars from the healthcare safety net.' But every year, the data tell a very different story. Only in the U.S. healthcare system can billions more in payments and spreads be considered a cut.”[8]

Whether it's using 340B eligibility to expand into financially prosperous communities for profit, structuring operations to maintain the bare minimum share of low-income patients required for 340B qualification, or other questionable actions, there is a demonstrated need for 340B reform.[9] The recent wins in the name of 340B reform achieved by pharmaceutical companies are steps in the right direction. Nevertheless, it is imperative that ongoing reform efforts reach a harmonious balance of weeding out bad actors, stabilizing the finances of covered entities acting in the best interests of their patient populations, and ensuring that pharmaceutical companies can continue to contribute without worrying about adverse effects to their operational finances.

[1] Health Resources & Services Administration. (2021). 340B drug pricing program. Retrieved from https://www.hrsa.gov/opa/index.html

[2] Grimm, D., Hethcoat, G., Trunk, S. (2024, June 27). The 340B ‘Saga’ Continued: HRSA, States, and Drug Manufacturers Contest 340B Contract Pharmacy Restrictions in Court. Retrieved from https://www.jdsupra.com/legalnews/the-340b-saga-continued-hrsa-states-and-9025687/

[3] Center for Medicine in the Public Interest. (2022, September 12). New Report Demonstrates How Hospitals, Pharmacies & PBMs Exploit the Federal 340B Drug Program to the Harm of Disadvantaged Patients

[4] Pitts, P., Popovian, R. (2022, September). 340B and the Warped Rhetoric of Healthcare Compassion. Retrieved from https://www.fdli.org/2022/09/340b-and-the-warped-rhetoric-of-healthcare-compassion/

[5] Hughes, S. (2024, July 26). AHA Comments Opposing the 340B ACCESS Act (H.R. 8574). Retrieved from https://www.aha.org/lettercomment/2024-07-26-aha-comments-opposing-340b-access-act-hr-8574

[6] ASAP340B. (2024, May 28). ASAP 340B Applauds Introduction of the 340B ACCESS Act. Retrieved from  https://www.asap340b.org/post/asap-340b-applauds-introduction-of-the-340b-access-act

[7] Hopkins, M. J., Macsata, B. M., & Laws, J. (2024, July). The 340B Drug Rebate Program and its potential impacts on annual revenues, executive compensation, and charity care provision in eligible covered entities. Nags Head, NC: ADAP Advocacy.

[8] Fein, Ph.D, Adam J. (2024, October 22) The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions. Drug Channels. Retrieved from https://www.drugchannels.net/2024/10/the-340b-program-reached-66-billion-in.html

[9] DiGiorgio, A. M., & Winegarden, W. (2024). Reforming 340B to Serve the Interests of Patients, Not Institutions. JAMA Health Forum, 5(7), e241356–e241356. https://doi.org/10.1001/jamahealthforum.2024.1356

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. 

HRSA Issues Numerous Guidance Letters Offering Patient Assistance

By: Ranier Simons, ADAP Blog Guest Contributor

The clients who qualify for and receive assistance through the Ryan White HIV/AIDS Program (RWHAP) are often representative of vulnerable populations. Providing a comprehensive means of providing HIV medications, healthcare, and related-services requires a whole-person approach. As such, Health Resources & Services Administration (HRSA) continues to evaluate and update its RWHAP endeavors to meet client needs. Systematic barriers exist that all to often challenge RWHAP clients’ ability to receive appropriate and consistent care. Recently, HRSA issued numerous guidance letters addressing those barriers.

HRSA has created patient assistance initiatives to enable a more seamless delivery service system aimed at addressing various socio-economic and systemic structural needs. Two of the program letters HRSA released in June 2024 address services for people living with HIV/AIDS (PLWHA) who have been involved in the criminal justice system, and those who are affected by housing insecurity.

PLWHA, who have been involved with the criminal justice system face barriers to access to care, among many other things. A person having legal involvement is defined as anyone who is engaged at any point along the continuum of the legal system as a defendant, including arrest, incarceration, and community supervision.[1] The HRSA HIV/AIDS Bureau (HAB) released guidance emphasizing how RWHAP funds may be used to support this demographic. RWHAP funds can be used to assist PLWHA who have been incarcerated or who are incarcerated and have an expectation of eligibility for RWHAP services upon release.[1] One effective means of support is assistance with the expungement of criminal records.

Photo Source: ADAP Advocacy | iStock Images

A criminal history is an obstacle to a person obtaining employment, housing, and education and subsequently affects access to healthcare. Expungement of criminal records improves the chances of successful reintegration into the community, reduces stigma, and protects privacy.[2] HRSA recognizes the importance of decreasing disparities to improve health outcomes for PLWHA. The expungement of criminal records facilitates obtaining gainful employment and securing housing, both of which translate into improving healthcare access. HRSA’s guidance informs providers that according to HRSA/HAB Policy Clarification Notice (PCN) #18-02, using RWHAP funds to help pay for expungement falls under the purview of allowable legal services because it is a matter “related to or arising from [an individual’s] HIV.”[1] Stipulations require any RWHAP recipients offering expungement services to research local laws, partner with legal counsel to create policies to determine how the services will be enacted, and ensure they are available to all eligible clients who seek help.[1]

In a related vein, in April 2024, HRSA announced new funding to support healthcare services for people transitioning out of incarceration. It earmarked $51 million to create funding opportunities for HRSA-funded health centers to develop innovative ways to give healthcare services to people in the 90-day period before their incarceration release.[3] Many people who are incarcerated have mental health conditions, substance abuse challenges, and chronic disease conditions such as HIV. The funding will enable HRSA-funded centers to provide care that ensures the continuity of medical services. This population needs case management services to help navigate things such as reinstating insurance eligibility, continuing access to medications and mental health counseling, reducing drug overdose risk, and even addressing housing and food insecurity.[3]

Regarding housing assistance, HRSA also released guidance educating providers, Policy Clarification Notice (PCN) #16-02, on an additional pathway RWHAP funds can be used to assist with housing instability. HRSA listened to clients who explained that statutory stipulations against using RWHAP funds to help pay housing security deposits for clients were a roadblock to helping them access stable and permanent housing.[4] As a result, HRSA/HAB issued guidance explaining that RWHAP funds can be used to pay for housing security deposits only if procedures are in place to ensure the security deposit is returned to the RWHAP service provider and not the RWHAP client.[4] It is not mandatory for RWHAP funds to be used for this purpose. Other funding sources, such as Ending the HIV Epidemic (EHE) funds, income generated from 340B program proceeds, and non-RWHAP grant awards, can also be used to help pay for housing security deposits.[4] This guidance is simply education on the existence of the option if needed.

HRSA has additional endeavors targeting the housing needs of PLWHA in the RWHAP. One of these is the SURE Housing initiative. SURE stands for Supporting Replication of Housing Interventions in the Ryan White HIV/AIDS Program. It is a program funded from 2022 through 2026 through HRSA’s RWHAP Part F Special Projects of National Significance Program.[5] Under this initiative, ten implementation sites are funded to create replicable effective interventions for rapid re-housing and housing stability for PLWHA who fall into one of three categories: those who have been involved with the legal system, those who identify as LGBTQ+, and young adults aged 18-24.[5]

With these guidance letters, HRSA/HAB has demonstrated its commitment to fostering an effective system, offering continuity of care and services for ADAP and RWHAP clients. HRSA continues to evaluate and modify current RWHAP offerings, communicate with recipients to investigate needs of new offerings, and examine how changing policy and legal landscapes affect funding rules and statutes. Housing instability and incarceration continue to complicate the lives of many PLWHA. It is imperative that government funding continues and scales with changing needs to ensure that no one falls through the cracks.

[1] HRSA HIV/AIDS Bureau. (2024, June 6). Ryan White Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hrsa-hab-expungement-program-letter.pdf

[2] Hamann, K., Riley, P., Bismuth, C. (2024, January 22).The evolving landscape of sealing and expungement statutes. Retrieved from https://www.americanbar.org/groups/criminal_justice/publications/criminal-justice-magazine/2024/winter/evolving-landscape-sealing-expungement-statutes/

[3] U.S. Department of Health and Human Services. (2024, April 10). Press Release: During Second Chance Month, HRSA Takes Policy Action, Releases First-Ever Funding Opportunity for Health Centers to Support Transitions in Care for People Leaving Incarceration. Retrieved from https://www.hhs.gov/about/news/2024/04/10/health-centers-to-support-transitions-in-care-for-people-leaving-incarceration.html

[4] HRSA HIV/AIDS Bureau. (2024, June 26). Ryan White Colleague Letter. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hrsa-hab-security-deposit-program-letter.pdf

[5] Target HIV. (2024). SURE Housing Initiative. Retrieved from https://targethiv.org/spns/SUREHousing

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.  

'Ending the HIV Epidemic' Enhances RWHAP Service Delivery; Report

By: Ranier Simons, ADAP Blog Guest Contributor

The population of people living with HIV/AIDS (PWLHA) is not monolithic. Their demographics vary as much as their needs. The Ryan White HIV/AIDS Program (RWHAP) provides funding for many HIV care and support services supporting over half of the people diagnosed with HIV in the United States.[1] The program is a safety-net ‘last-resort’ source of funding for those designated as low-income, who have no insurance, who are underinsured, or who have insurance limitations. However, there are restrictions to what RWHAP funds can be used for, leaving some needs unsupported. The advent of the Ending the HIV Epidemic Initiative (EHE) in 2020 required additional funding support to enhance the service delivery system.

Photo Source: TargetHIV

The focus of the EHE is 47 geographic jurisdictions where HIV has the highest transmission rates. The additional funding for these areas allows RWHAP recipients to expand their capability to reach those unaware of their status and those who have fallen out of or are not in regular care. The EHE funds are more flexible in their allowed usage, enabling tailored approaches not included in RWHAP statutes. Not only do they support additional efforts to reach new and different subpopulations, but they also provide training to expand the workforce in those EHE-identified areas.

HRSA recently released a data report highlighting diverse characteristics and successful outcomes of clients served who are new to care or have been re-engaged to care with the providers who have received the EHE funds. The report also highlights EHE-funding-enabled efforts by providers.

One significant hurdle EHE funding enables providers to overcome is rapid initiation of care, which directly impacts viral suppression. This is notable since in 2022, EHE-funded providers served 22,001 clients new to care and 19,204 re-engaged into care.[1] Research shows that getting a person into treatment and care as soon as possible after HIV diagnosis provides the best possible health outcomes.[2] EHE funding enabled providers to link patients new to care to treatment more quickly after identification and/or diagnosis without having to wait until the completion of RWHAP eligibility assessments. The assessments can take up to 30 days. With the EHE funding, providers are guaranteed reimbursement if a potential client ends up not being RWHAP eligible.[1] Therefore, a newly diagnosed client can get into almost immediate care, has medication and care linkage, and is given the gift of time to navigate services if found ineligible.

Photo Source: HRSA

A notable data finding in the report is differences of socioeconomic factors. Regarding housing, newly diagnosed and re-engaging clients of EHE-funded providers faired poorer than RWHAP clients overall.[1] Approximately 15% of new EHE clients and 11% of re-engaged EHE clients were dealing with temporary housing situations compared to 6.9% of all clients served by the RWHAP.[1] Concerning unstable housing, 9.4% of new EHE clients and 4.3% of re-engaged EHE clients reported experiencing housing instability in contrast to 5.2% of all clients served by the RWHAP.[1]

The same trend continued regarding poverty. Approximately 68.9% of new clients and 64.3% of re-engaged clients of those served by EHE-funded providers lived at or below 100% of the federal poverty level compared to 58.6% of the overall RWHAP population.[1] This is indicative of comparative insurance trends between the two groups. Approximately 43.8% of new EHE clients had no health insurance coverage compared to 18.2% of overall RWHAP clientele.[1] New and re-engaged clients of EHE-funded providers also had lower rates of viral suppression. Approximately 79.2% of new clients and 85.1% of re-engaged clients had achieved viral suppression in contrast to 89.6% of RWHAP clients overall.[1] One caveat to this data metric is that the reported numbers are based on what is achieved by the end of the year. People who are new or returning to care may not have had time to achieve viral suppression yet.

In addition to client-level statistics, the data report details many ways EHE funding facilitated extended means of support, education, and expansion for recipients, helping them better target their communities' specific needs. EHE funding enabled providers to create programming and provide staffing in ways not permitted with RWHAP funds. Some clients were able to improve access to care by extending hours and days of service, providing funds for clients with transportation issues to use Lyft to get to facilities, and even using funding to pay for additional staff to meet needs that were currently not being satisfied.[1]

Providing community-specific services is paramount to assisting the populations the EHE is focused on. EHE funding allowed recipients to not only hire needed medical professionals but also train community members to provide services for their peers, such as client navigation and Linkage-to-Care coordination.[1] One of the recipients reported, “Data and Linkage to Care (DLTC) personnel are funded through EHE for aiding any person living with HIV in [our area with] accessing care and supportive services … Community Health Workers-Case Manager Supervisor [CHW-CMS] roles were implemented through EHE for expansion of HIV workforce within the state to assist with non-medical case management services. CHW-CMSs are not supported through the [redacted] Ryan White Part B and [AIDS Drug Assistance Program].”[1]

Photo Source: HRSA

In support of reaching EHE goals, EHE funding was also used by the RWHAP Part F AIDS Education and Training Center (AETC) Program to provide clinical training and organizational infrastructure education.[1] Regional AETC EHE-funded trainings were aimed at various providers and health professionals who were either new to servicing PLWHA or had limited experience due to low-volume exposure.[1] They also targeted professionals such as dentists, psychiatrists, nurse practitioners, and pharmacists. These practitioners encounter PLWHA and thus can benefit from training to enhance their ability to understand their clientele and provide appropriate care. EHE-funded AETC training topics included HIV prevention, PrEP education, STI screening in primary care, and even HIV stigma and discrimination education.[1]

The EHE initiative targets explicitly communities with the highest rates of HIV transmission. EHE funding creates new opportunities and avenues for those already utilizing RWHAP funds to do even more. Most importantly, EHE funds allow for services to be provided to clients in need who do not meet RWHAP income requirements. This data report shows that continued EHE funding is necessary to effectively end the HIV epidemic by enabling an arsenal of tools and solutions that are as varied as the populations in need.

[1] HRSA. (2024). Who We Are. Retrieved from https://ryanwhite.hrsa.gov/

[2] Benson, C., Emond, B., Romdhani, H., Lefebvre, P., Côté-Sergent, A., Shohoudi, A., Tandon, N., Chow, W., & Dunn, K. (2020). Long-Term Benefits of Rapid Antiretroviral Therapy Initiation in Reducing Medical and Overall Health Care Costs Among Medicaid-Covered Patients with Human Immunodeficiency Virus. Journal of managed care & specialty pharmacy, 26(2), 117–128. https://doi.org/10.18553/jmcp.2019.19174

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.  

HRSA Offers Guidance on Doxy-PEP to Stem the Tide of Rising STIs Among PLWHAs

By: Ranier Simons, ADAP Blog Guest Contributor

According to the Centers for Disease Control & Prevention (CDC), there were 2.5 million reported cases of gonorrhea, chlamydia, and syphilis in the United States in 2022.[1] The rates of sexually transmitted diseases (STIs) have been increasing globally, which is of particular concern for people living with HIV/AIDS (PLWHA). One strategy that is proving highly successful in combatting the spread of STIs is Doxy-PEP (post exposure prophylaxis).

Photo Source: The Washington Post

The presence of HIV in the body can, in some cases, make it harder to treat STIs.[2] Additionally, an STI can increase the HIV viral load in PLWHA who are not on treatment regimens.[3] For those with good antiretroviral adherence, an STI is not likely to change someone from undetectable to detectable. However, the numerous harms STIs inflict on the body make it essential to reduce STIs' impact on PLWHA. The Health Resources & Services Administration (HRSA) recently issued a letter to Ryan White HIV/AIDS Program (RWHAP) colleagues emphasizing their role in lowering the risk of STIs for PLWHA, as well as awareness of new clinical guidelines on the use of doxy PEP in preventing bacterial STIs.[4]

Doxy-PEP is the administration of 200 mg of doxycycline within 24-72 hours of condomless anal, vaginal, or oral sex and should not exceed a maximum of 200mg in any 24hr period.[5] Studies have shown that Doxy-PEP reduces syphilis and chlamydia infections by more than 70% and gonococcal infections by approximately 50%.[5]

Men who have sex with men (MSM) and transgender women (TGW) have been identified as groups disproportionately affected by STIs. Thus, CDC guidelines recommend that medical professionals target MSM and TGW who have had a bacterial STI in the past twelve months to offer education and counseling on the benefits of Doxy-PEP. After counseling and education, if desired, providers should provide prescriptions for Doxy-PEP to be self-administered.[5]

Photo Source: The PrEP Clinic

HRSA’s letter specifically encourages RWHAP recipients to adopt the CDC guidelines and integrate Doxy-PEP into their protocols and clinical programs. The letter also urges state AIDS Drug Assistance Programs (ADAPs) to add Doxy-PEP to their drug formularies to facilitate equitable access and coverage for their eligible populations. In case they are unaware, HRSA reminds RWHAP colleagues that purchasing Doxy-PEP is an allowable cost. “RWHAP Parts A, C, and D recipients may contribute RWHAP funds to ADAPs to purchase medications and/or health care coverage and medication cost sharing for ADAP-eligible clients.”[4]

Proper administration of Doxy-PEP requires STI testing every three to six months, as well as evaluation of the appropriateness of continued utilization of doxy PEP.[5] Increasing the number of those utilizing the antibiotic intervention will also increase the instances of contact with care professionals. Increased contact means more opportunities for strengthening linkages to care and exploration of other points of need. One of the main goals of RWHAP is to improve the health outcomes of PLWHA. Adoption of Doxy-PEP practices and protocols would be another tool to add to comprehensive whole-person care along with established practices such as harm-reduction and risk-reduction counseling, facilitating access to PrEP, and regular STI testing.

Photo Source: The PrEP Clinic

Notably, HRSA’s letter highlighted the RWHAP Part F's AIDS Education and Training Center (AETC) Program and the RWHAP Part F Special Projects of National Significance Addressing STIs: “Ask. Test. Treat. Repeat.” Initiative.[6,7] Both programs provide training and information on the proper implementation of Doxy-PEP and ways to adopt and normalize routine testing of STIs. This letter from HRSAs HIV/AIDS Bureau is more than just an F.Y.I. It is a tangible outreach of support for RWHAP colleagues. 

Ryan White-funded organizations work tirelessly to stretch federal dollars to improve the health and well-being of the vulnerable populations of PLWHA they serve. Clear guidance on Doxy-PEP and the proliferation of educational resources directly acknowledges that the federal government is an active partner with and sees and embraces the efforts of RWHAP recipients.

[1] CDC. (2024, January 30). CDC’s 2022 STI Surveillance Report underscores that STIs must be a public health priority. Retrieved from https://www.cdc.gov/std/statistics/2022/default.htm

[2] U.S. Department of Health & Human Services. (2024, June 27). Sexually Transmitted Infections. Retrieved from https://www.hiv.gov/hiv-basics/staying-in-hiv-care/other-related-health-issues/sexually-transmitted-diseases#:~:text=Many%20STIs%20do%20not%20have,if%20you're%20sexually%20active.

[3] Stanford, A. (2023, September). Undetectable viral load and HIV transmission. Retrieved from https://www.aidsmap.com/about-hiv/undetectable-viral-load-and-hiv-transmission

[4] HRSA. (2024, July 31). Letter to Ryan White HIV/AIDS Program Colleagues. Retrieved from https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/hab-doxy-pep-clinical-guideline-bacterial-sti-prevention.pdf

[5] CDC. (2024, June 6). CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024. Retrieved from https://www.cdc.gov/mmwr/volumes/73/rr/rr7302a1.htm

[6] AIDS Education and Training Center Program. https://aidsetc.org/topic/sexually-transmitted-infections

[7] TargeyHIV.org. (2024). Addressing STIs: Ask. Test. Treat. Repeat. https://targethiv.org/intervention/addressing-stis-ask-test-treat-repeat?utm_source=bpURL

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.  

2023 Ryan White HIV/AIDS Program Biennial Report Now Available

By: Health Resources and Services Administration’s HIV/AIDS Bureau

The Health Resources and Services Administration’s (HRSA) HIV/AIDS Bureau (HAB) is excited to share that the 2023 Ryan White HIV/AIDS Program Highlights biennial report is now available.

To highlight innovative models of HIV care and treatment that Ryan White HIV/AIDS Program and HAB Ending the HIV Epidemic in the United States (EHE) initiative recipients implement in communities across the country, HRSA HAB publishes a report every two years. These reports provide an update of Ryan White HIV/AIDS Program and HAB EHE efforts to improve health outcomes for people with HIV and document the successes and challenges of recipients.

Titled Harnessing the Power of Community Engagement and Innovation to End the HIV Epidemic: 2023 Ryan White HIV/AIDS Program Highlights, the 2023 biennial report features seven Ryan White HIV/AIDS Program and HAB EHE recipients who have implemented effective strategies and syndemic approaches to HIV care by addressing health disparities and engaging the HIV community in the planning and implementation of programs. The seven recipients have focused on partnering with service providers to deliver innovative programs to priority populations, conducting outreach to youth, offering housing services, providing mpox vaccine distribution, facilitating peer-led engagement of transgender women, and integrating oral health services and dental training. These and other HRSA RWHAP recipients provide inspiration for leveraging community engagement and innovation to end the HIV epidemic in the United States.

Please note Harnessing the Power of Community Engagement and Innovation to End the HIV Epidemic: 2023 Ryan White HIV/AIDS Program Highlights is not copyrighted. Readers are free to duplicate and use all or part of the information contained in this publication; however, photographs require permission to be reproduced. For suggested citation, please see page ii in the report.

To read the 2023 report and previous biennial reports, please visit: https://ryanwhite.hrsa.gov/data/biennial-reports.

Editor's Note: Laura Cheever and Heather Hauck from the HIV/AIDS Bureau shared this update on October 17th via email to Ryan White HIV/AIDS Program Colleagues. No editorial analysis or comment has been provided by ADAP Advocacy.

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.

Viral Suppression Linked to Access to Timely, Appropriate Care and Treatment

By: Ranier Simons, ADAP Blog Guest Contributor

One of the most critical factors influencing positive health outcomes of people living with HIV/AIDS (PLWHA) is viral suppression. Viral suppression means that the HIV viral load in the blood is so low that it cannot be detected or measured by laboratory tests. Viral suppression is officially defined as having less than 200 copies of HIV per milliliter of blood.[1] Antiretroviral drug therapy (ART) is the current scientifically established most effective way to achieve undetectable viral load status. Studies have routinely shown that viral suppression is a directly associated with PLWHA having access to timely, appropriate care and treatment.

Photo Source: Ideal Healthcare

ART is as vital for prevention as it is for treatment. Maintaining an undetectable viral load means the virus cannot be transmitted to an HIV-negative person through sexual contact.[2] Maintaining undetectable status requires consistent adherence to ART regimens. Unfortunately, many PLWHA face barriers which make medication adherence a challenge. Two significant barriers are affordability and access to ART regimens. 

AIDS Drug Assistance Programs (ADAPs) were created in 1987, and then incorporated under the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act in 1990 to provide HIV-related prescription drugs to low-income PLWHA who have limited or no prescription drug coverage.[3] The state-administered programs pay for insurance and medical care for 20% of PLWHA in the United States.[4] The Ryan White law states that the purpose of ADAPs is to "provide therapeutics to treat HIV disease or prevent the serious deterioration of health arising from HIV disease in eligible individuals, including measures for the prevention and treatment of opportunistic infections."[5] ADAPs achieve this goal for low-income PLWHA by providing antiretroviral medications and paying for health insurance that covers HIV-related treatments.

To participate in ADAPs, recipients are required to regularly recertify their eligibility for the programs. People are eligible when they meet the criteria of having a documented diagnosis of HIV, fall within the program parameters that define low-income, and meet a particular ADAP’s residency criteria within its service area.[6] Data has shown that many PLWHA struggle to complete the recertification requirements and thus become dis-enrolled. For an in-depth description of the burdensome recertification process, please see a previous ADAP Advocacy blog discussion on the topic here. In an effort to examine the effects of dis-enrollment on viral suppression, a group of researchers performed a study of ADAP clients in Washington state who failed to re-certify and were dis-enrolled.

Photo Source: Washington State

A retrospective cohort study published in May 2023 was performed on 5238 clients in Washington State's ADAP from 2017 to 2019.[4] The researchers used various quantitative and statistical analyses to determine the risk difference of viral suppression before and after dis-enrollment. Several factors, or what are statistically known as unmeasured confounders, overlap in regard to causing dis-enrollment and medication discontinuation. Those confounders include housing instability, poor mental health, binge drinking, and illicit drug use.[4] Stringent statistical efforts were used to isolate the influence of dis-enrollment from those confounders.

A total of 1336 study subjects were dis-enrolled at least once or more than once within the time parameters examined. Results showed that overall, 12 out of every 100 PLWHA lost viral suppression due to dis-enrollment. Disenrollment had an exceedingly harmful effect on those with dual Medicaid/Medicare insurance (22/100) compared to those with private insurance (8/100).[4] Having dual Medicaid/Medicare coverage means that a person has a disability.

During the 2017-2019 window of the cohort study, ADAP clients were required to recertify every six months. Researchers found that those who failed to recertify lost viral suppression almost immediately afterward.[4] Around 83% were virally suppressed before dis-enrollment versus 69% after. This indicates that changes need to be made in the re-certification process to make it less complicated for enrollees to complete and reduce the administrative burden on providers.

In October 2021, Health Resources & Services Administration (HRSA) removed the six-month re-certification requirement. Given that the six-month requirement has deleterious effects on enrollment, it is recommended that ADAPs end the practice of using the six-month default and adopt the newer flexibility in the re-certification policy. The study also noted that Washington state ADAP offers a more extensive breadth of services than most other states. Thus, some Washington state clients who are ADAP enrollees use it for other services and obtain their medications by other means. Therefore, dis-enrollment could have a much more significant impact on viral suppression in other states where every person enrolled in ADAP is dependent on it for their ART.

[1] Centers for Disease Control. (2022, July 21). HIV Treatment as Prevention. Retrieved from https://www.cdc.gov/hiv/risk/art/index.html

[2] World Health Organization. (2018, July 20).Viral suppression for HIV treatment success and prevention of sexual transmission of HIV. Retrieved from  https://www.who.int/news/item/20-07-2018-viral-suppression-for-hiv-treatment-success-and-prevention-of-sexual-transmission-of-hiv

[3] Kaiser Family Foundation. (2017, August 16). AIDS Drug Assistance Programs (ADAPs). Retrieved from https://www.kff.org/hivaids/fact-sheet/aids-drug-assistance-programs/.

[4] Erly SJ, Khosropour CM, Hajat A, Sharma M, Reuer JR, Dombrowski JC (2023) AIDS Drug Assistance Program disenrollment is associated with loss of viral suppression beyond differences in homelessness, mental health, and substance use disorders: An evaluation in Washington state 2017–2019. PLoS ONE 18(5): e0285326. https://doi.org/10.1371/journal.pone.0285326

[5] Penner, M. (2008, October 1). AIDS Drug Assistance Programs: A Lifeline for People With HIV. Retrieved fromhttps://www.thebodypro.com/article/aids-drug-assistance-programs-lifeline-people-hiv#1

[5] Resources Health and Administration Service. (2021, August). Determining Client Eligibility & Payor of Last Resort in the Ryan White HIV/AIDS Program. Report No.: PCN 21–02. Retrieved from https://hab.hrsa.gov/sites

[6] Feller, S. (2023, May 13). Monoclonal antibody speeds time to HIV viral suppression, study finds. Retrieved from https://www.healio.com/news/infectious-disease/20230512/monoclonal-antibody-speeds-time-to-hiv-viral-suppression-study-finds?utm_medium=social&utm_source=twitter&utm_campaign=sociallinks

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.