Comments to CMS on their proposed rule to codify the Medicare price negotiation program

Dr. Mehmet Oz, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, Maryland 21244

Submitted electronically via Regulations.gov
Docket No. CMS-2026-2080-0001

Re: CMS-4215-P: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

Dear Administrator Oz:

The HIV+Hepatitis Policy Institute is a national organization promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions. We submit these comments on the Centers for Medicare & Medicaid Services’ proposed rule to codify the Medicare Drug Price Negotiation Program (“Negotiation Program”) for initial price applicability year 2029 and beyond (CMS-4215-P).

In April 2023, as CMS was first standing up the Negotiation Program, we commented that patients were looking forward to the benefits promised under the Inflation Reduction Act while closely monitoring whether the program would translate into lower out-of-pocket costs and fewer access barriers for patients.^[1] We raised specific concerns at that time. CMS’s approach to manufacturer data collection ignored the aggregate nature of drug research and development, the 30-day public comment window was too short for patient groups to meaningfully participate, and the guidance on formulary inclusion of negotiated drugs was a single sentence that did not guarantee patients would see the benefit of lower prices through reduced cost-sharing or fewer utilization management barriers, including adverse tiering.

Three negotiation cycles later, many of those concerns remain. More than 111,000 Medicare beneficiaries are currently living with HIV, a number expected to roughly double over the next decade as people living with HIV age into Medicare, which makes the design of this program more consequential for our community with each negotiation cycle.^[2]  This rulemaking is the first opportunity to codify the Negotiation Program in binding regulatory text rather than annual sub-regulatory guidance, and codification is the appropriate moment to close these gaps. Patients were promised that this program would deliver meaningful affordability and access improvements, and CMS should use this rulemaking to make good on that promise through enforceable, not merely discretionary, standards. Our comments below address patient engagement in the negotiation process, transparency in how patient input is used, formulary access and utilization management protections for selected drugs, and additional concerns about the negotiation methodology itself.

1. Strengthen Meaningful Patient Engagement in the Negotiation Process
Proposed §§ 429.505(d), 429.515(b)

The proposed rule codifies, for the first time in binding regulatory text, CMS’s process for collecting patient and public input into the negotiation of a maximum fair price (MFP). Proposed § 429.505(d) would allow any interested party, including patients and patient organizations, to voluntarily submit the clinical and patient-experience evidence CMS considers when negotiating a selected drug’s price, through the Information Collection Request (ICR) process. Proposed § 429.515(b) would codify CMS’s practice of holding public engagement events, which may include patient-focused roundtables and a clinical town hall.

Having participated in the ICR, a patient roundtable, and the clinical town hall this past cycle, we offer the recommendations below informed directly by that experience. We want to acknowledge, before turning to those recommendations, that CMS staff have made a genuine, voluntary effort to improve this process and solicit more patient input with each negotiation cycle. We appreciate that effort; however, opportunities for true patient engagement must be greatly enhanced. This rulemaking is an opportunity to make permanent what has already worked and fix what has not.

The current process treats patient advocacy organizations mainly as a place to collect individual stories, not as a source of systemic evidence. This is true across the ICR, the roundtables, and the town hall alike. All three are structured around discussion of a single selected drug, while our expertise lies in the broader experience of our population, affordability, insurance design, and access barriers across conditions and treatments, not in comparing the clinical merits of one product against another. However, we understand that CMS must consider each drug individually, and we provided appropriate clinical evidence on that particular drug.

We consider ourselves very knowledgeable of HIV and hepatitis treatment, including the regimens patients are prescribed and how they are used, but we struggled to respond to parts of this process. That is because the ICR sorts respondents into four categories: patient or caregiver-focused input, manufacturer-focused input, clinical-focused input, and health research-focused input, but the questions within each are written around one person’s relationship to a drug. A patient describes what it is like to take it, a clinician what it is like to prescribe it, a manufacturer what it cost to bring it to market, and a researcher what the published evidence shows. Patient organizations fall under the patient or caregiver category, but the questions there ask about individual experience, not the aggregate, cross-membership perspective an organization actually has. We see how patients across different plans, states, and stages of disease access an entire category of treatment, and we track patterns in affordability, formulary placement, and utilization management that no single account can show.  Below are several recommendations aimed at improving the process.

A. Written Engagement Through the Information Collection Request (ICR)
We found the ICR difficult to respond to because of its format, complexity, and the short period we had to respond to the questions. Although any respondent could answer any of the 57 questions in the five sections, most respondents could focus on their section. Because patient advocacy organizations did not have a section of their own but could respond to topics and questions from many of the sections, such as clinical, insurance coverage, and affordability, we had to go through all of the sections and decide which questions to answer where, since many of the questions overlapped.

The process is also far more demanding than a typical comment letter. CMS’s general instructions for how to answer the questions run five pages on their own, before a respondent even reaches the 57 questions spread across nearly 30 pages of substantive content. Every submission also requires a formal certification, a signed and dated statement attesting that the information provided is true and made in good faith, closer to what a legal filing requires than a public comment process. Citations are one example of the technical detail required throughout. Sources must be listed in National Library of Medicine style, with a PubMed ID or DOI included where available, then compiled into a single PDF document and uploaded inside a zip file. CMS’s own burden estimate for this collection, filed under the Paperwork Reduction Act, allots up to 1,000 hours per response for manufacturers and just 30 hours for organizations and three hours for individuals, all working from the same instructions and the same citation and certification requirements. This is an unrealistic expectation for busy patients, clinicians, and smaller patient advocacy organizations.

Recommendations

• Give patients and clinicians more time to respond. We recommend CMS establish a separate, longer submission deadline for patients, patient organizations, and clinicians and researchers, at least 60 days from when selected drugs are announced. Manufacturers face a 30-day deadline set by statute, but nothing in that requirement prevents CMS from giving other respondents more time to prepare a meaningful submission.
• Create a dedicated question section for patient advocacy organizations. We recommend CMS create a section within the ICR written specifically for patient advocacy organizations, asking for the aggregate, cross-membership evidence organizations are positioned to provide, such as patterns in formulary placement, utilization management, and affordability across the population they serve, rather than requiring organizations to piece together answers from sections written for individual respondents.
• Simplify how patients, clinicians, and organizations can submit. We recommend CMS accept a plain letter or a simple, direct-entry form as an alternative to the current questionnaire for patients, clinicians, and patient organizations, without requiring the technical sourcing, citation, and file-formatting steps built for manufacturer submissions.
• Publish who has submitted comments. We recommend CMS publish a list of organizations and categories of respondents who submitted ICR input for each selected drug, similar to how public dockets identify commenters on other rulemakings.

B. Patient Roundtables
We found the roundtable discussions to be a positive and useful experience, and a genuine improvement over the town hall format, since participants could build on each other’s responses rather than delivering isolated statements. While this was our experience, we understand from other patient groups that theirs was different, with fewer opportunities for real discussion. Our main concerns are with consistency rather than the format itself; participant counts have varied widely from cycle to cycle.

Recommendations

• Make roundtables mandatory, not discretionary. We recommend CMS replace discretionary language with mandatory minimum requirements throughout proposed § 429.515(b). CMS should require, not merely permit, at least one condition or drug-specific patient roundtable for every selected drug and every drug undergoing a renegotiation, while preserving CMS’s flexibility to hold additional events beyond this minimum.
• Expand who gets a seat at the table. We recommend CMS publish its application and nomination process, selection criteria, and the number and type of participants ultimately selected for each roundtable. In practice, some roundtables have had as few as three participants, well under the stated maximum of six, even as organizations that applied were not selected, which suggests a selection process problem, not just a numbers problem. Six participants, or fewer, is not a serious attempt to capture the range of experience associated with a widely used drug; CMS should be willing to scale participation into the dozens where interest and capacity allow. We also recommend CMS conduct proactive, affirmative outreach to patient organizations, including a transparent and maintained list of organizations by disease area and direct outreach immediately after drugs are selected, rather than relying on a CMS webpage announcement to generate participation.

C. Clinical Town Halls
Our experience with the town hall gave us the opportunity to present our views, though we believe the format could be improved to produce more meaningful discussion. Its broad, public format could foster a genuinely open forum centered on dialogue and exchange rather than a series of individual statements. We hope to see that potential realized in future cycles.

Recommendations

• Keep town halls condition-specific. We recommend CMS avoid combining multiple selected drugs into a single broad town hall when condition-specific discussion would be more useful. At a recent town hall, four selected drugs across different disease states were combined into a single session, which did not allow for meaningful discussion of any one condition.
• Increase the number of participants. Our session had only four participants, even though we know more people requested the opportunity to take part. A larger, more representative group would produce more meaningful input.
• Give town hall speakers more time and a real chance to respond to follow-up questions. We recommend CMS extend the time limit for town hall remarks from four minutes to at least six to eight minutes, and allow each speaker the opportunity to respond to a follow-up question if they wish, rather than selecting only one speaker to do so. At a recent town hall, HIV was allocated only one substantive follow-up question across all speakers, which did not allow for meaningful discussion.

2. Explain How Patient Input Affects the MFP
Proposed §§ 429.520(b)(3), 429.705(b)(1)

The proposed rule takes a step toward transparency. Proposed § 429.520(b)(3) would allow the concise justification accompanying CMS’s initial offer to include information obtained through public engagement events, and proposed § 429.705(b)(1) would require the published MFP explanation to include redacted information submitted by interested parties under § 429.505(d)(3). Neither provision, however, requires a clear connection between what a specific patient or organization told CMS and how that shaped the price CMS ultimately negotiated.

Right now, even the patients and organizations who participate in the ICR, roundtables, or town halls do not learn what themes CMS identified, whether their input influenced the negotiation, or why particular recommendations were or were not incorporated. A process that asks patients and organizations to spend hours describing their experience with a disease and its treatment owes those participants a clear account of what became of that input.

This matters more for our population than most. A Medicare beneficiary’s out-of-pocket experience is shaped as much by their Part D plan’s benefit design, their Low-Income Subsidy status, and Ryan White Program wraparound coverage as it is by a drug’s negotiated price. Most Medicare beneficiaries living with HIV qualify for the Low-Income Subsidy, and many rely on Ryan White as a payer of last resort for costs Medicare does not cover. Without CMS explaining how patient-reported affordability experience factors into its analysis, it is not clear whether that input is being weighed correctly, or at all, given how many variables sit between a negotiated price and what a beneficiary actually pays.

Recommendations

• Publish a clear, drug-specific account of how patient input was used. We recommend CMS require that the published MFP explanation include a narrative description of how patient engagement was considered in developing the negotiation, without disclosing confidential commercial or financial information. At minimum, that narrative should address the patient-reported experience with the selected drug and its therapeutic alternatives that informed CMS’s understanding of the drug’s clinical and quality-of-life value, along with which patient organizations and participant categories CMS consulted; the principal patient-experience themes it received; whether that information supported an upward adjustment, a downward adjustment, or no adjustment to the starting point; why significant patient recommendations were accepted or rejected; and what information CMS found insufficient and would seek in future cycles.
• Publish an annual report on the engagement process as a whole. We recommend CMS publish an annual cross-program report evaluating its engagement process as a whole, including participation levels, representativeness of participants, lessons learned, and changes planned for the following year, separate from the drug-specific MFP explanation required under § 429.705(b).

3. Formulary Access and Utilization Management Protections for Selected Drugs
Proposed § 423.120(b)(2)(vii)–(viii)

The proposed rule codifies the statutory requirement that Part D plans include a selected drug with an agreed-upon MFP on their formularies, along with a corresponding exception permitting plans to remove a selected drug from a formulary under existing substitution and notice provisions. We appreciate CMS codifying the formulary inclusion requirement itself.

CMS explains in the preamble that it will continue using its comprehensive annual formulary review process to examine tier placement and utilization management for selected drugs. Under that process, plans may be required to provide a “reasonable justification” for placing a selected drug on a non-preferred tier, treating it less favorably than a non-selected drug in the same class, or applying more restrictive prior authorization or step therapy. We support that review, but the proposed regulatory text does not establish a selected-drug-specific mechanism for identifying and promptly correcting access barriers that arise after a plan’s formulary has been approved. Annual review at the bid stage is not sufficient when a beneficiary encounters adverse tiering, inappropriate utilization management, or pressure to switch therapies during the plan year.

CMS has already prohibited prior authorization for antiretrovirals in Part D, including for HIV treatment and post-exposure prophylaxis, and antiretrovirals are one of six protected classes in which Part D plans must cover all or substantially all available drugs. As selected antiretrovirals move through the Negotiation Program, CMS should confirm that nothing in this rule’s formulary and utilization management provisions creates a loophole around those existing protections.

The consequences of inadequate formulary protections more broadly are well documented. Non-medical switching, where a stable patient is moved to a different drug within the same class for cost rather than clinical reasons, is associated with a negative impact on medication adherence in 75 percent of the cases reviewed in a systematic literature review.^[3] Research on stable HIV patients who underwent a first-line regimen switch found that switchers experienced significantly higher subsequent healthcare costs and ambulatory utilization compared to patients who did not switch.^[4]

Cost-sharing has a similarly direct effect on whether patients take their medications at all, and tier placement is often the single biggest driver of what a patient pays out of pocket. A 2021 IQVIA analysis found that Medicare beneficiaries facing a copay of $75 or more, the kind of cost-sharing associated with a specialty or non-preferred tier, abandon their prescription 25 percent of the time.^[5] For a population that depends on continuous, uninterrupted antiretroviral therapy to maintain viral suppression and prevent drug resistance, these are not abstract risks.

Recommendations

• Codify enforceable limits on utilization management, not just formulary inclusion. We recommend CMS codify that utilization management applied to a selected drug must be clinically grounded, no more restrictive than what applies to therapeutic alternatives in the same class, and enforceable by CMS throughout the plan year rather than only at the bid-review stage. This standard should serve as a floor, not a ceiling, and should not be construed to diminish any stronger existing protections, such as the current prohibition on prior authorization for antiretrovirals in Part D.
• Require standardized, plan-level public reporting on access outcomes. We recommend CMS require standardized, plan-level public reporting of outcomes for selected drugs, including prior authorization approval and denial rates, appeal outcomes and time-to-determination, changes in beneficiary out-of-pocket costs, prescription abandonment, treatment switching, formulary tier placement, coverage of non-selected therapeutic alternatives, beneficiary complaints and appeals, pharmacy and provider access problems, and disparities in access and affordability, disaggregated by drug and by plan.
• Establish year-round monitoring and expedited corrective action. We recommend CMS require plans to report material changes in tier placement or utilization management affecting selected drugs during the plan year and establish a clearly identified process through which beneficiaries, prescribers, and patient organizations may report emerging access barriers. CMS should investigate credible reports promptly and require corrective action when a plan cannot demonstrate that its restrictions are clinically appropriate, consistent with treatment guidelines, and no more restrictive than those applied to comparable non-selected drugs.
• Prohibit using formulary changes to pressure stable patients to switch. We recommend CMS make clear that plans may not use formulary or utilization management changes to pressure a stable patient to switch treatments solely because a different product in the same class has an MFP, and that CMS will monitor for this pattern as part of the reporting described above.

4. Additional Concerns
Proposed §§ 429.125(b)(4)(i),  429.510(e)–(f)

This section addresses proposed § 429.125(b)(4)(i), which governs CMS’s treatment of reformulated drugs with a new route of administration, and proposed § 429.510(e) and (f), which govern how CMS adjusts the negotiation starting point and preliminary price based on the clinical and economic factors in section 1194(e) of the Act, along with three related concerns about how the negotiation methodology treats reformulation incentives, research investment, and comparative effectiveness evidence.

New formulations and route-of-administration changes. Proposed § 429.125(b)(4)(i) would address circumstances where a manufacturer reformulates an existing drug to enable a more patient-friendly route of administration, for example, converting an intravenous infusion into a subcutaneous injection a patient can self-administer. These reformulations typically require significant additional clinical development and regulatory review, and meaningfully reduce the burden of treatment for patients. CMS should ensure this proposal does not treat a reformulated product as functionally identical to the original for negotiation purposes in a way that discourages manufacturers from investing in these improvements. A negotiation framework that does not distinguish this kind of innovation risks disincentivizing exactly the type of investment that makes treatment more accessible to patients.

Aggregate research and development investment. Evaluating a single approved drug’s costs and revenues in isolation does not capture the years of research and the cost of failed candidates that came before it, or the manufacturer’s ongoing investment in future indications and other drug development. For patients, this matters less as an abstract economic argument and more as a direct link to what treatments will exist in ten years. Continued investment in long-acting HIV and hepatitis therapies, prevention products, and progress toward a cure depends on manufacturers’ ability to invest across a broad and largely unprofitable pipeline, and today’s patients have benefited directly from exactly that kind of aggregate investment in the therapies many of them now rely on.

QALYs and discriminatory cost-effectiveness measures. We support CMS’s proposed prohibition on using evidence in a manner that assigns less value to the lives of older, disabled, or terminally ill people, consistent with the ban on quality-adjusted life years (QALYs) and similar measures in Medicare coverage and reimbursement decisions under section 1182(e) of the Act. Multiple government and private studies, including a report from the National Council on Disability, have found that QALYs undervalue the lives of people with disabilities and chronic or life-threatening conditions.^[6] We ask CMS to explain how it will identify and remove discriminatory assumptions when an otherwise useful clinical study contains a QALY or similar measure, rather than excluding the study altogether or letting the measure pass through unaddressed, and to confirm that patient-reported outcomes will not be displaced by generalized economic measures anywhere in its analysis.

Conclusion
We welcome CMS taking this crucial step to formalize the Medicare Drug Price Negotiation Program in binding regulation. We urge CMS to ensure the final regulatory text establishes mandatory patient engagement, transparent accounting of patient input, and limits on utilization management and tier gaming on selected drugs. Only through binding standards will lower negotiated prices translate into genuine access and affordability for people living with HIV, hepatitis, and other chronic conditions.

If you have any questions or need additional information, please do not hesitate to reach out to our Government Affairs Director, Zach Lynkiewicz, at zlynkiewicz@hivhep.org.

Sincerely,

Carl E. Schmid II
Executive Director

[1] HIV+Hepatitis Policy Institute, Comments on the Medicare Drug Price Negotiation Program Initial Memorandum (Apr. 14, 2023), https://hivhep.org/testimony-comments-letters/comments-on-the-medicare-drug-price-negotiation-program-initial-memorandum/.

[2] Hyle EP, Ang L, Luu G, et al. “Costs associated with increasing numbers of Medicare beneficiaries with HIV aged 65 years and older from 2026 to 2035.” medRxiv. December 27, 2025. https://www.medrxiv.org/content/10.64898/2025.12.19.25342703v1.

[3] W Weeda, E. R., Nguyen, E., Martin, S., Ingham, M., Sobieraj, D. M., Bookhart, B. K., & Coleman, C. I. (2019). The impact of non-medical switching among ambulatory patients: an updated systematic literature review. Journal of market access & health policy, 7(1), 1678563. https://doi.org/10.1080/20016689.2019.1678563.

[4] Rosenblatt, L., Buikema, A. R., Seare, J., Bengtson, L. G. S., Johnson, J., Cao, F., & Villasis-Keever, A. (2017). Economic Outcomes of First-Line Regimen Switching Among Stable Patients with HIV. Journal of managed care & specialty pharmacy, 23(7), 725–734. https://doi.org/10.18553/jmcp.2017.16403.

[5] Greenwalt, L. (2021, November 30). Understanding the impact of cost sharing in pharma: Cost is a powerful control of patient behavior. IQVIA. https://www.iqvia.com/locations/united-states/blogs/2021/11/understanding-the-impact-of-cost-sharing-in-pharma.

[6] National Council on Disability. (2019). Quality adjusted life years and disability discrimination: An analysis of the disabilities addendum to the life-years lost methodology (Report). https://www.ncd.gov/assets/uploads/reports/2019/ncd_quality_adjusted_life_report_508.pdf.