CMS Draft Guidance for the Medicare Drug Price Negotiation Program (IPAY2028) Comments

Thank You for the opportunity to provide comments on CMS’s Draft Guidance for the Medicare Drug Price Negotiation Program (IPAY2028). 

As background, HealthHIV is a national non-profit working with healthcare organizations, communities, and providers to advance effective HIV, Hepatitis C (HCV), 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, effective antiretroviral therapy (ART) for HIV care.

We would first like to recognize several aspects of the guidance that reflect thoughtful policy design. CMS’ plan to publish explanatory summaries outlining the rationale and data sources behind each Maximum Fair Price (MFP) is a welcome step toward transparency, especially for communities historically excluded from drug pricing decisions. We also support the built-in mechanism for correcting manufacturer data errors, which—while narrow in scale—can help prevent pricing distortions that might otherwise affect treatment access. And we appreciate CMS’ intent to incorporate updated real-world utilization data into its MFP application process. This utilization flexibility is especially critical when looking at HIV, where dosing and formulation often shift as clinical needs evolve over a lifetime (and across multiple morbidities). Unlike many other drug classes, there are relatively few gold-standard, Grade A HHS treatment guidelines in the HIV space—both in the current docket and in the development pipeline. That makes it even more important for CMS to protect the few high-efficacy options available, rather than risk restricting access through rigid pricing or grouping policies.

And it’s through the lens of antiretroviral therapy (ART)—where individualized dosing plays a critical role in adherence and health outcomes—we see several areas of the guidance that warrant deeper consideration and contextualization, particularly around how CMS proposes to group and value HIV medications. 

With that, we respectfully highlight five concerns:

1. Grouping Rules for STRs Can Risk Undermining Treatment Stability

Recognizing that single-tablet regimens (STRs) are the foundation of long-term, oral formulation HIV care, the proposed framework overlooks some core clinical realities, personal and public health outcomes, and the everyday adherence challenges that People with HIV (PWH) face. 

As outlined, CMS suggests that all drugs can be grouped for negotiation if they share a single active moiety, even if they are part of different fixed-dose combination products. But in HIV care, these combinations are not clinically (or always therapeutically) interchangeable. In fact, very recently, three Prescription Drug Affordability Boards (PDAB) came to that same conclusion (CO, MD, OR) in removing HIV medications from their affordability reviews.

STRs, we’ve learned, simplify a person’s treatment regimen and support more routine uptake and adherence—all of which help prevent viral resistance, reduce transmission, and keep people healthier. That’s especially true for individuals with complex medical or psychosocial needs. This is the long-standing medical practice of U=U or “undetectable equals untransmissible”. In practice, it’s the cornerstone of the President’s End the HIV Epidemic work. 

In HIV care, even small disruptions to access can have serious consequences. As proposed, the guidance risks overlooking how treatments function in daily, lifelong care. Even when regimens share some of the same ingredients, their effects, side effects, and how they interact with other medications can differ in some really important ways. For people with high-acuity needs—including those aging with HIV, experiencing cognitive decline, managing comorbidities, or facing housing instability—single-tablet regimens (STRs) offer a simplified and effective approach that reduces pill burden and supports better adherence.

Here’s one example of how things play out in one state—and the influence STRs have on adherence, health, and costs. A December 2024 report from Washington State’s AppleHealth (Medicaid) program found that STRs were used by over 58% of people with HIV, up from 49.5% in 2022. The report also found that the use of STRs was associated with an 86% viral suppression rate, compared to 81% among those on multiple-tablet regimens (MTRs). These recent findings highlight the clear clinical and economic value of STRs—and point to why CMS must evaluate grouping and pricing policies through the lens of real-world outcomes, not just shared ingredients. 

Treating STRs as interchangeable based on a single, shared ingredient misses how HIV medications actually work in people’s lives. These are not plug-and-play treatments—especially for individuals with advanced HIV, complex health needs, or aging-related concerns. And switching meds isn’t always straightforward; it often involves coordinating case management (medical and supportive), in addition to getting insurance approvals, checking supplies, and ensuring the new therapy is actually available. Without that type of support, PWH can risk running out of meds or falling through the refill or eligibility cracks; and that can ripple across housing, pharmacy, and support systems Without that coordination, providers, too, feel the administrative burden and strain—having to step in with more clinical oversight, more follow-up, and more effort to keep someone on track. Substitutions under CMS’s current approach doesn’t reflect these realities, and opens the door to cost-based decisions that put treatment stability, provider judgment, and long-term health at risk.

2. Prevention and Adherence Outcomes Must Be Part of the Equation

CMS’s proposed value framework does not account for viral suppression, adherence outcomes, or the public health cost of averted HIV transmissions. 

The estimated lifetime cost of treating one HIV infection exceeds $450,000. ART regimens—particularly STRs and more recently (and effectively) long-acting injectables—prevent new infections and maintain suppression across vulnerable populations. For many, these medication formulations are not optional; they are the difference between viral control and rebound, and potential onward transmission. 

If CMS chooses to negotiate prices without factoring in these long-term public health impacts, it will fail to reflect the true value of HIV treatment and prevention. That approach may be penny-wise but pound-foolish.

3. Public HIV Innovation Should Be Protected, Not Penalized

Much of the HIV treatment pipeline has been advanced through public sector investment. NIH, NIAID, and BARDA have all played critical roles in supporting the development of new ART formulations. These contributions should be treated as evidence of national commitment to HIV innovation, not as a reason to suppress prices or undermine market viability.

Using federal support as a downward pricing factor may discourage future innovation in a field that already faces steep development costs and scientific hurdles. And with the recent FDA-pause of the Wonders 1,2 Trials, the pipeline for new small-molecule HIV therapies is already shrinking. CMS should be careful not to accelerate that decline. Oral formulations are still the backbone of HIV treatment. 

4. Transparency and Stakeholder Engagement Are Lacking

The current guidance provides no meaningful opportunity for external stakeholders—including HIV providers, advocates, and affected communities—to review the data and rationale used to group drugs or assign maximum fair prices (MFPs). These choices—made entirely within the agency—will directly shape access to medications that PWH depend on for viral suppression and survival.

In the context of HIV care, even minor disruptions to regimen access can lead to viral rebound, resistance, or loss of adherence—driving up both acute and long-term costs across systems, from emergency care to housing instability and other supportive service needs. When CMS leaves out the voices of those who prescribe, rely on, and study these therapies every day, it risks making decisions that are out of step with both clinical practice and real-life care. ART isn’t abstract—it’s a lifetime commitment. Commitment that comes with real consequences if access is ever destabilized. 

5. Downstream Disruptions Could Erode Continuity of Care

While the guidance prevents direct substitution of a negotiated drug with a lower-cost alternative, it does not prevent plans from steering patients toward lower-cost options within a grouped drug class. That leaves room for utilization management tools like step therapy, prior authorization, or narrow networks to drive forced switching.

For people living with HIV, especially those with histories of treatment failure, switching regimens can lead to resistance or loss of viral suppression. CMS must do more to monitor and mitigate these downstream effects, including requiring plan-level data on ART stability and treatment continuity.

We urge CMS to:

• Refrain from grouping STRs or other fixed-dose combinations based on shared moieties alone.

• Integrate adherence, viral suppression, and transmission prevention data into drug valuation.

• Recognize and protect publicly supported HIV innovations.

• Build-in transparent stakeholder input and publicly reviewable rationale for grouping and pricing.

• Establish safeguards and monitoring mechanisms for post-negotiation switching and treatment disruption.

Thank you for your leadership and the opportunity to provide input. CMS has an opportunity to shape this program in a way that reflects not just economic logic, but medical reality and the lived experiences of people aging with and managing HIV across their lifetime. We urge you to keep the needs of People with HIV at the center of CMS’ implementation.

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