Lessons learned from the CMS Medicare Drug Price Negotiation Program listening sessions

CMS’s listening sessions for the Medicare Drug Price Negotiation Program (DPNP) highlighted gaps in inclusivity and structure, prompting recommendations for two-way dialogue and diverse patient engagement.

The Centers for Medicare and Medicaid Services (CMS) has taken significant steps to engage patients in its DPNP, a key provision of the Inflation Reduction Act (IRA). Patient-focused listening sessions held in late 2023 aimed to incorporate patient perspectives on the first 10 drugs selected for price negotiations. However, a recent analysis by the National Pharmaceutical Council (NPC), published in the journal PharmacoEconomics – Open, identified areas for improvement in the sessions' structure and effectiveness.

Key findings from the NPC study

The NPC study, authored by Julie Patterson and colleagues, analyzed remarks from over 100 speakers across 10 listening sessions. The sessions aimed to gather input on the first 10 drugs selected for price negotiation under the IRA. Despite this goal, the analysis revealed gaps in diversity, inclusivity, and the depth of evidence provided:

• Of the anticipated 200 speaker slots, only 106 were filled, representing 70 unique speakers. Most participants were patients (54.2%), women (57.1%), and below Medicare age (57.1%). 82.9% were White, highlighting a lack of diversity.
• Speakers focused primarily on patient experiences (36.5% of speaking time) and patient access or benefit design (12.1% of speaking time). CMS received a median of just 12.3 minutes of evidence about selected drugs or therapeutic alternatives per session.

“This study sought to quantitatively show the limited window provided by the one-way communication structure with patients and their representatives in the first round of listening sessions,” said Dr Patterson, the study’s lead author and NPC Senior Director of Research. “We applaud CMS administrators for recognizing the limitations of the passive listening format and hope that the next series of patient-focused events will prioritize two-way discourse informed by science and transparency.” 

Recommendations for future sessions

To address these limitations, the NPC study outlined several recommendations to enhance patient engagement:

• Enhanced communication: CMS should prioritize meaningful, two-way dialogue with patients, caregivers, providers, and advocacy organizations. Clear objectives should be communicated to establish partnerships and ensure transparency about how input informs the DPNP process.
• Logistical improvements: Event logistics should be improved to facilitate broader participation. Recommendations include providing translation services, accommodations for patients with disabilities, and multi-modal outreach to reach diverse patient populations.
• Diverse representation: Efforts should be made to ensure participants reflect the Medicare population, including greater representation from underserved and minority communities, to capture a wider range of perspectives and experiences.

Dr Tyler D Wagner, study co-author and NPC Associate Director of Research, emphasized,

“Our hope is that this study helps CMS understand how the volume or focus of speaker remarks may shift in future iterations of patient engagement events if there is more clarity about how that input will be used by the agency.”

Updates for the second cycle

CMS has incorporated lessons from the first round of negotiations into its finalized guidance for the second cycle, covering up to 15 additional Part D drugs to be selected by February 2025. Key updates include:

• Patient engagement: CMS will host up to 15 “patient-focused roundtable events” organized by condition. These sessions will promote discussion, include patients and advocacy organizations, and allow clinicians to participate in town hall meetings with other stakeholders.
• Real-world evidence (RWE): CMS will place greater emphasis on RWE in negotiations, using it to evaluate clinical benefits and therapeutic alternatives. Stakeholders are encouraged to submit robust analyses from patient registries or randomized studies to support decision-making.

CMS has also revised procedures for negotiations with drug companies, allowing more time for discussions and introducing data exchange requirements to ensure fair pricing and patient access.

“The patient-focused listening sessions for the first ten drugs selected for the IRA’s Drug Price Negotiation Program were an important, but limited, first step toward patient engagement with the DPNP,” the NPC study noted. By implementing these improvements, CMS aims to create a more inclusive, transparent process that ensures diverse perspectives are heard and informs meaningful policy decisions.

Negotiated prices for the first round of drugs will take effect on January 1, 2026, saving Medicare beneficiaries an estimated $1.5 billion in out-of-pocket costs. These updates, alongside new provisions like the $2000 annual cap on drug costs starting in 2025, underscore CMS’s commitment to improving affordability and access for patients.