Today, CCPA submitted comments to the Centers for Medicare and Medicaid Services (CMS) in response to its draft guidance for the next phase of the Medicare Drug Price Negotiation Program. The comments urge CMS to strengthen patient engagement, protect access to care, and ensure that policies reflect the lived experiences of people with chronic conditions.
The full text of CCPA’s submitted comments is shared below.
—
June 26, 2025
Chris Klomp, MBA
Deputy Administrator and Director of the Center for Medicare
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
RE: Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of
Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability
Year 2028 and Manufacturer Effectuation of the Maximum Fair Price in 2026, 2027, and 2028
Electronically Submitted via
IRARebateandNegotiation@cms.hhs.gov
Dear Deputy Administrator Klomp,
We write on behalf of patient organizations representing individuals living with a range of chronic and serious health conditions. As the Medicare Drug Price Negotiation Program (MDPNP) enters its next phase, we urge CMS to prioritize transparency, inclusivity, and clarity in how patient voices are incorporated into the negotiation process.
While we acknowledge and appreciate CMS’s expanded engagement efforts during the IPAY 2027 cycle—particularly through tailored questionnaires, structured roundtables, and patient-specific sessions—there remains a significant gap between collecting patient input and demonstrating how that input informs agency decisions.
The Chronic Care Policy Alliance (CCPA) unites state and regional advocacy organizations to champion public policies that enhance the lives of individuals living with chronic conditions and diseases. We are deeply connected to patients and advocates who participated in the process. They report feeling heard in the moment, but ignored and adrift as the process unfolds beyond the initial calls they participated in.
Many patients who participated in the process report feeling ignored or disenfranchised. If CMS is sincere in its commitment to fostering dialogue with the patient community, then it must be equally committed to showing how patient insights shape policy outcomes.
- Improve Patient Engagement in the IPAY 2028 Process
We commend CMS for improvements made during the IPAY 2027 cycle, including expanded engagement opportunities and clearer channels for patient feedback.
- The updated questionnaires were designed to elicit more authentic patient experiences, and the option to save responses and return later offered participants much-needed flexibility in completing the forms.
- The roundtable format allowed for meaningful conversations and interaction among participants, a major improvement over the prior year’s more static testimonial format.
- Holding patient-specific sessions in a private setting encouraged candid discussion while respecting the sensitive nature of patients’ health information.
Clinical town halls created additional opportunities for diverse stakeholders to contribute to the conversation without overshadowing patient voices.
Despite this progress, we believe additional steps are needed to enhance the experience and effectiveness of future engagement:
- The registration process for both roundtables and written questionnaires was confusing and burdensome—especially for elderly patients. We strongly recommend that CMS provide live technical assistance and helplines for those who need support navigating these tools or simplify the tools.
- CMS should ensure that roundtable participants are appropriately screened so that clinical input and value assessments are directed to the appropriate venue (e.g., town halls), reserving the patient-centric nature of patient-focused roundtables.
- To increase representation and participation, multiple roundtables should be offered for each selected drug. The current limitation of nine participants per session significantly restricts the diversity of input.
- Patients were required to complete a generic participation form that included language inappropriate for this context, such as permissions related to disclosure of their private addresses and permission to access and film at private residences. CMS should revise this form to align specifically with the roundtable’s purpose and remove irrelevant and intrusive requirements.
- Protect Against Discriminatory Value Metrics
We appreciate CMS’s reaffirmation that it will not use research that treats extending the life of individuals who are elderly, disabled, or terminally ill as of lower value than others, in line with statutory protections. CCPA and other patient advocates have long opposed such discriminatory metrics such as Quality Adjusted Life Years (QALYs), which devalue the lives of people with chronic conditions or disabilities.
We urge CMS to go further by safeguarding against any quality metrics that produce similarly harmful outcomes—regardless of whether they are explicitly labeled as QALYs or merely replicate QALY-based methodologies. The result for patients is the same: reduced access to care and undervaluation of their health needs. As CMS evaluates evidence and research, it must ensure all methodologies used treat patients fairly, equally, and with full respect for their unique needs and experiences.
- Protect Patient Choice and Individuality
Additionally, in reviewing comparative effectiveness research, we urge CMS to view patients as individuals—not as aggregates. A treatment that works for most may not work for all, and for some, it may be the only option that does. Overreliance on population averages risks excluding the outliers for whom a therapy may be most beneficial. Incorporating individual patient experiences into value assessments will help ensure that negotiated prices reflect real-world benefit without inadvertently restricting access.
In that same spirit, we are concerned by CMS’s decision to treat different medicines as the same drug if they share an active ingredient, even when they serve different purposes or are delivered in distinct ways. This interpretation discourages follow-on research aimed at improving treatments for patients—such as developing new formulations, expanding indications, or making therapies easier to use. Each of these advancements can make a meaningful difference in patients’ lives. CMS should reverse this policy and recognize each approved medicine as a distinct product, consistent with the intent of the law.
- Ensure Patient Access to All Medications
Access to care must remain a foundational principle of the MDPNP. We are concerned that formulary changes driven by negotiated pricing could deprioritize higher-cost or non-negotiated drugs, even when they are the best option for an individual patient. Similarly, the use of utilization management tools such as step therapy or new prior authorization requirements could further restrict access.
While we appreciate CMS’s discussion of existing protections in Part D, we urge the agency to go further by establishing clear, proactive safeguards to prevent such barriers. This includes mechanisms to monitor implementation, create transparent complaint processes, and ensure that access to all therapies remains unchanged relative to the pre-negotiation environment.
- Protect Provider Reimbursement and Preserve Treatment Choice
For the first time, drugs covered under Part B will be subject to negotiation under IPAY 2028. As this new phase unfolds, we urge CMS to carefully consider how negotiated prices may affect physician reimbursement and, by extension, patient access. Providers treating complex chronic conditions already face financial strain, and reductions in reimbursement could lead to fewer treatment options being offered to patients—especially if physicians can no longer afford to administer certain therapies.
Patients deserve treatment decisions based on clinical need, not provider financial feasibility. We urge CMS to establish fair reimbursement policies that make providers financially whole and allow care decisions to remain where they belong—with the patient and their doctor.
- Sustain Engagement Throughout the Negotiation Lifecycle
Patient engagement should not end with a roundtable or listening session. It must be integrated throughout the negotiation process. CMS should regularly convene briefings with patient organizations to share updates, solicit feedback, and identify early signs of access disruptions. These ongoing conversations are vital to maintaining the trust and involvement of the communities most directly affected by negotiation decisions.
We appreciate the improvements CMS has made and hope to see continued progress in patient engagement in the 2028 cycle and beyond. We welcome the opportunity to serve as a resource and partner in this work.
Please direct any questions or follow-up to Liz Helms, Founder and Director, Chronic Care Policy Alliance, at lizh@chroniccarealliance.org. Thank you for your continued attention to these important matters.
Sincerely,
Liz Helms
Founder/Director
Chronic Care Policy Alliance
1001 K ST. 6th Floor
Sacramento, CA 95814
www.chroniccarealliance.org