HealthHIV 340B Rebate Model Pilot Program Comments

April 20, 2026

Thank you for the opportunity to provide comments on the Health Resources and Services Administration’s (HRSA) Request for Information on the proposed 340B Rebate Model Pilot Program. Our submission focuses primarily on implications for HRSA-covered entities (CEs) and related Ryan White, Ending the HIV Epidemic (EHE), and Section 318 programs across operations, financing, and patient access. And while we don’t provide detailed quantitative or operational metrics, we offer a grounded account of how these models function in practice and where they create risk for the HIV safety net.

As background, HealthHIV is a national non-profit working with healthcare organizations, communities, and providers to advance effective HIV, viral Hepatitis, and sexually transmitted infection (STI) care through education and training, technical assistance and capacity building, advocacy, communications, and health services research and evaluation. HealthHIV submits this response grounded in decades of experience supporting education for providers and public programs that depend on uninterrupted and effective antiretroviral therapy (ART) for HIV care.

Executive Summary: The proposed 340B rebate model introduces added administrative and financial considerations for HRSA-covered entities and related HIV programs, with implications for how care is delivered and sustained. It also brings cash-flow and operational complexities that could affect patient access and the stability of the HIV safety net. If implemented, it will require clear safeguards for the providers in these programs, including workable timelines, strengthened oversight, and auditing to ensure the model functions as intended without disrupting care.

Additional Context: The 340B program isn’t perfect. In large (often for-profit) hospital systems and specialty care centers with their own pharmacies, the way these systems are structured and how they make money from pharmacy operations have pushed the program beyond its original intent. These systems are largely driving the call for reform, including this Pilot. Those concerns have long been raised by HRSA CEs that deliver HIV community services, which operate under defined scopes of work, contracts, and regular auditing requirements. But those standards are not applied in the same way across larger systems, where much of the drift is occurring. This pilot puts HRSA CEs in double jeopardy, first from compliance and now from cash-flow concerns.

HRSA CEs (including Ryan White-funded providers), as well as EHE, and Section 318-funded providers are subject to audits and oversight, with compliance monitoring by the HRSA Office of Pharmacy Affairs (OPA) for 340B entities and programmatic and fiscal oversight tied to grants and scopes of work.

In consolidated systems, program savings often don’t make it back to patient care. That creates pressure to grow and capture more of it. That’s the issue. A rebate model moves in a different direction without addressing the underlying issues that call for stronger oversight and real auditing of “bad actors.” It shifts financial risk onto HIV providers and disrupts how care is delivered. All of that weakens the HIV care infrastructure and leaves those problems in place. And this concern isn’t theoretical; it’s how these programs actually operate in practice. Any rebate model, as implemented, should preserve existing ADAP (AIDS Drug Assistance Program) structures and avoid creating parallel systems that disrupt how these programs actually work today.

If HRSA moves forward with the rebate model, it needs to more accurately acknowledge the risk and depict how ADAPs, Ryan White, EHE, and Section 318 programs actually operate. These programs sit within and often straddle different systems and structures. Not all 340B or Ryan White–related CEs function the same way—and that matters for how the rebate model would hit them.

Some are clinical providers—places that see patients directly. They prescribe medications, keep medical records, and deliver care. They can be Ryan White clinics, community health centers, or clinics. Their ability to ensure cash flow is resourced appropriately isn’t uniform.

Other entities may operate their programs through multiple administrative layers; they don’t see patients directly but still manage payment and coordination—paying for medications, handling benefits, working through pharmacies, and coordinating services. They often use contract pharmacies that dispense drugs on behalf of a CE that can’t afford to run its own pharmacy. They may also involve a third-party administrator (TPA) to manage those arrangements. Those layers add cost and create ongoing cash flow pressure because the entity still has to pay those partners even though it isn’t delivering care itself. At the same time, they hold contracts that allow them to use those funds within their scopes of work.

The patient may not interact with the CE at the pharmacy counter, even though they are engaged with the CE for care. They may fill prescriptions at a contract pharmacy rather than a CE-owned pharmacy. While some models have the capacity to do it all, it doesn’t make programs with less cash flow outlay any less important in the HIV ecosystem. These programs still help patients access and stay on medications and remain in lifelong care, and serve an important role within the ecosystem. They can also involve both medical and non-medical components, such as supportive services, to coordinate patient care, coverage, and adherence. They don’t prescribe, but they’re central to keeping patients involved in their lifelong care.

In many cases, the entity responsible for purchasing or managing drugs is not the same entity that writes the prescription or holds the clinical record. And that split matters.

Meeting these requirements would force system changes and contract revisions under state procurement rules. This mandate doesn’t come with funding. Purchasing at WAC (the Wholesale Acquisition Cost) creates immediate cash flow exposure and risks, especially when federal awards are delayed or come in tranches, and especially for smaller programs, but in the meantime, expenditures and cash outlays for HRSA CEs and related Ryan White, EHE, and Section 318 programs don’t cease. States might further engage in the use of carve-outs to control and direct how dollars are used, especially through ADAP and Medicaid structures. The point, historically, is an intentional steering of funds, not just “leveraging.” This is a way of shaping program dollars around state priorities, but those dollars may not actually reach community-level services or patient needs in the same way. Requirements should also align with Medicaid and other federal programs to prevent duplicate discounts and conflicting claims across payers.

Different manufacturer portals all have their own rules, so providers have to navigate inconsistent requirements. The model should include clear reconciliation processes and standardized denial requirements to ensure claims are handled consistently and transparently across entities. But when claims are denied, it’s often unclear why. Managing these systems takes extra time and resources, and if they’re not handled properly, they can also create risks around patient data privacy. Short submission windows—such as the 45-day requirement—don’t align with how these programs operate. They don’t align with state processes, funding cycles, or how claims are generated. That means that any single claim doesn’t always sit with just one CE. When there are short windows or first-come rules, the claim that gets submitted later can be denied—even if it’s the correct one—simply because of timing. So decisions end up being based on who submitted first, not necessarily who is actually responsible for the claim.

In short, the 340B program has always been a lifeline for HIV care, and it should be protected. Its benefits aren’t abstract—they’re the dollars that keep a case manager on staff, the labs that track viral suppression, and the premiums that stop lifesaving HIV treatment from being interrupted. Dropping a rebate model into this already fragile system risks accelerating and exacerbating the very outcomes already on the horizon. Coverage losses mean more people with no other options turning to existing safety-net programs. Premium hikes can also drive ADAP costs higher and stretch already flat budgets even thinner. ADAP shortfalls can force states to ration, cut eligibility, or even reduce formularies. And waitlists, long thought to be part of history, could once again be used to ration care. 

Taken together, these issues point to a mismatch between the model and the programs it depends on.

Our requests are straightforward, but urgent for the communities we serve, and HHS must decide whether it intends to safeguard the HIV safety-net or potentially (further) weaken it through this pilot. That said, we respectfully request that you:

1. Exempt HIV and prevention drugs from the rebate pilot entirely, recognizing the substantial solvency risks to Ryan White programs and ADAPs.
2. If exemptions aren’t granted, require upfront chargebacks so CEs never have to pay more than the 340B ceiling price at purchase.
3. Centralize data submission under HRSA or some neutral clearinghouse, not across multiple manufacturer portals, with strict limits on required fields and independent privacy safeguards.
4. Guarantee rebate payments within ten days as enforceable, with penalties and interest for delays or denials.
5. Conduct impact assessments specific to HIV safety-net providers before any expansion, with public reporting on denial rates, payment timelines, and program solvency impacts.
6. Delay implementation for one year to allow Ryan White programs, ADAPs, and other HIV safety-net providers to build up the infrastructure, agreements, and financial reserves necessary to withstand a WAC-first purchase model without disrupting patient care.
7. Establish workable submission timelines and clear claim standards, including transparent denial reasons, and a process to resolve conflicting claims across CEs.
8. Strengthen oversight and auditing of the 340B program to address known issues directly, rather than shifting the model in ways that create new risks for providers and patients.

Anything less will weaken the HIV safety-net at the exact moment that it is most needed.

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