The EACH/PIC Coalition submitted a group letter signed by 24 organizations to the Centers for Medicare and Medicaid Services (CMS) in response to the Medicare Drug Price Negotiation Program Guidance for Initial Price Applicability Year 2029 (IPAY 2029). The letter urged for continued improvements to and transparency throughout the public engagement process.
The letter stated:
While we applaud CMS for moving to a roundtable format for patient-focused engagement, there is opportunity to improve the roundtables to better accommodate patients, facilitate better discussion, and gather more relevant data.
We encourage CMS to provide participants with more information prior to the roundtables. Participants in the sessions reported feeling unprepared for specific questions as well as not understanding what data was sought by CMS. We therefore encourage CMS to consider providing selected participants with a plain-language briefing document before each session with sample questions and suggestions on information that participants might want to gather in advance. This would allow participants to prepare thoughtful responses and ensure the limited discussion time is used as effectively as possible.
Additionally, we encourage CMS to allow participants to share information on the value of their medications as well as all the factors that impact their care. CMS appropriately seeks to understand the clinical benefit of selected drugs, but patients often define a medication’s value more broadly than clinical outcomes alone. Access to treatment, affordability, continuity of care, and the ability to remain on a therapy without unnecessary disruptions are integral to patients’ experiences and quality of life. Participants frequently felt these topics were outside the intended scope of discussion, despite being inseparable from how patients assess a medication’s value. CMS should ensure discussion topics reflect the full real-world experience of living with and managing a chronic condition. …
Each year, patients, caregivers, providers, and patient organizations invest significant time preparing written submissions, completing applications, participating in roundtables and town halls, and sharing deeply personal experiences about living with serious and chronic diseases. Yet once these activities conclude, participants receive virtually no information regarding what CMS learned from these discussions or how patient experiences informed the negotiation process. Beyond publication of a redacted transcript, there is no explanation of the themes CMS identified, how patient perspectives influenced negotiations, whether recommendations were incorporated, or why certain recommendations were ultimately not adopted.
This lack of transparency risks undermining confidence in the engagement process itself. Participants should not be expected to repeatedly dedicate substantial time and effort without any indication that their experiences meaningfully contribute to agency decision-making. If CMS cannot demonstrate the value of participation, patients, caregivers, providers, and patient organizations may understandably begin to disengage from the process altogether.
To address this gap, CMS should publish a Patient Engagement Summary following each negotiation cycle that identifies the major themes raised during public engagement, explains how those perspectives informed the agency’s deliberations, and describes where patient recommendations influenced the negotiation process. Closing this feedback loop would demonstrate that participation has meaningful value and strengthen confidence in future engagement opportunities.