CMS Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program Comments

Dr. Mehmet Oz 

Administrator 

Centers for Medicare & Medicaid Services (CMS)

Department of Health and Human Services Attention: CMS-4215-P 

P.O. Box 8013 

Baltimore, MD 21244-8013 

Dear Administrator Oz,

Thank You for the opportunity to provide comments on CMS’s Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program (CMS-4215-P). 

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. HealthHIV also appreciates the intent behind this proposed regulation.

In summary, we urge CMS to:

• Integrate adherence, viral suppression, and transmission prevention data into drug valuation.
• Recognize and protect publicly supported HIV innovations, the clinical importance of off-label ART medication use in HIV care, and the clinical importance of injectable medications.
• Build-in transparent and effective stakeholder input, and publicly reviewable and substantive rationale for grouping and pricing.
• Establish safeguards and monitoring mechanisms for post-negotiation switching and treatment disruption.
• Engage in holistic and data-driven evaluation of the bona fide marketing of generics and biosimilars.

In summary, we appreciate CMS’ intent to:

• Incorporate crucial considerations regarding transfer of manufacturer responsibilities.
• Incorporate a Temporary Floor for Small Biotech Drugs.
• Incorporate updated real-world utilization data into its MFP application process.

In additional detail:

We would first like to recognize several aspects of the proposed rule that reflect thoughtful policy design:

• CMS’ intent to incorporate crucial considerations regarding transfer of manufacturer responsibilities is very appreciated.Proposed § 429.210(c) is an important access safeguard, clarifying that Negotiation Program responsibilities remain in place when a selected drug is transferred to another manufacturer. Any such change in corporate ownership shouldn’t create additional uncertainty regarding who makes the negotiated price available to patients—this consideration matters even more in light of the absence of covered pharmacies in many areas, with the degree of vertical integration of pharmacies nationwide continuing to increase. 
• CMS’ intent to incorporate a Temporary Floor for Small Biotech Drugs is also appreciated. Proposed § 429.440 provides a temporary pricing protection for qualifying small-biotech drugs in 2029 and 2030, which may help preserve development incentives as those products enter negotiation. While this floor may have a limited impact now, this protection could become highly relevant for smaller companies developing HIV medications—notably, biologics have been a crucial tool in efforts to fully eliminate HIV reservoirs, as discussed during the 2026 Ryan White Conference. 
• We also 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 recommendations in the HIV space—both in the current treatment landscape and in the development pipeline. That is even more important for CMS to recognize and protect the high-efficacy options supported by those recommendations

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 proposed rule that warrant deeper consideration and contextualization, particularly around how CMS proposes to group and value HIV medications.

Under proposed § 429.125(b)(4)(i), CMS may group certain new formulations with an existing drug when an added ingredient enables a different route of administration. Two medicines can contain much of the same drug and still work very differently for a patient if one is a pill and another is a long-acting injection. HealthHIV encourages CMS, when applying this policy, to preserve recognition of differences that can directly impact how patients receive and access treatment. Within the HIV care continuum, any changes in the route of administration can improve or complicate adherence (by adding appointment, transportation, or coverage requirements), and affect dosing frequency, how and where care is delivered, benefit pathways, and practical access. This is particularly resonant with innovation in the HIV landscape, as long-acting treatment (injectable and longer-acting oral formulations) options continue to expand.

With that, we respectfully highlight five potential concerns:

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

CMS’s proposed value framework does not effectively 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 may not fully reflect the true value of HIV treatment and prevention.

2. Innovation Should Be Protected, Not Penalized

Much of the HIV treatment pipeline has been advanced through public sector investment. NIH and NIAID have each 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 potentially undermine market viability. § 429.125(c))3)(i) similarly preserves an important innovation incentive by starting that seven-year drug / 11-year biologic negotiation clock when a drug loses its orphan-drug exclusion. This is wholly relevant to HIV care models, where orphan designation can support development for smaller, harder-to-treat populations. For people with multi-drug-resistant profiles, this protection supports development of new medications or modalities of delivery and action when existing therapies are no longer as effective or, in fact, work. We find that preserving the full protected period helps ensure population scale, in and of itself, does not discourage development of new treatments for those with few(er) remaining options. That incentive is increasingly important as some state Medicaid and AIDS Drug Assistance Program (ADAP) programs revisit formulary and utilization management policies that can affect which HIV regimens are practically accessible, underscoring the inherent importance of maintaining viable communicable disease treatment options. 

Under § 429.415(a)(2), CMS looks to treat drugs that are typically administered only once as 12 thirty-day equivalent supplies. For recurring Part B drugs, CMS may use the observed time between administrations, which is important for long-acting HIV treatment because access delays can make the interval appear longer than the intended dosing schedule. Finally, CMS must ensure that the intended treatment timeline for injectable forms of ART and PrEP is fully accurate, reflects real-world treatment considerations, and doesn’t undervalue the clinical importance of injectable medications via the outlined “days between services” approach.

As the HIV treatment ecosystem continues to evolve, off-label utilization of ART medications remains a clinically important evolution (and source of innovation) in HIV care. Sections 429.605 and 429.610 propose that an off-label use may count as a new indication for renegotiation only when the primary manufacturer voluntarily submits that use and it involves a disease or condition not previously indicated. We encourage CMS to make full use of federal treatment guidelines, clinical evidence, Medicare utilization data, and patient and provider input (especially those raised during the Town Halls) when determining whether drug use or other clinical, social-determinant, or mitigating factors materially affect the statutory factors considered for renegotiation.

Broadly, 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 FDA-pause of the Wonders 1 and 2 Trials, the pipeline for new small-molecule HIV therapies is already shrinking. Additionally, while oral formulations are still the backbone of HIV treatment, emerging injectable forms of long-acting ART should receive appropriate and accurate consideration as well—in addition to off-label utilization of ART medications.

3. Transparency and Stakeholder Engagement Are Limited

While steps toward gleaning greater stakeholder input are appreciated, the current proposed rule doesn’t provide adequate opportunities 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 doesn’t adequately include 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. 

4. Downstream Disruptions Could Erode Continuity of Care

While the proposed rule 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.

5. Characterization of Bona Fide Marketing of Generics and Biosimilars Risks Creating an Inaccurate Picture of the Treatment Landscape

The current proposed rule inaccurately characterizes the HIV treatment landscape with respect to bona fide marketing of generics and biosimilars. Generic entry should not be treated as evidence of clinically relevant competition.

In the HIV treatment landscape, just because a given ART drug is on a given formulary, doesn’t mean that it’ll be practically available for patients. CMS should look to real-world evidence to determine said practical availability: Medicare prescription sales utilization, private plan sales data, and other important sources of information, are all crucial in making any qualification of the treatment landscape. CMS should practically and holistically assess whether generic competition is meaningful in practice—is there sufficient supply, will distribution be sustained, and will access be maintained? 

Fundamentally, for patients on HIV medications, the question remains—can they consistently get the medication(s) that they need?

In conclusion:

Thank you again for your leadership and the opportunity to provide input. CMS has an opportunity to shape this program in a way that reflects not only economic logic, but also medical reality and the lived experiences of people living, aging with, and managing HIV across their lifetimes. We urge you to keep the needs of People with HIV at the center of CMS’ implementation of CMS-4215-P.

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