By: Allen Pinn, Coordinator, Policy

August 16 marked two years since the Inflation Reduction Act (IRA) was signed into law. The legislation included multiple provisions related to Medicare drug coverage including a $2000 cap on out-of-pocket drug costs, a $35/month insulin cap, and improved access to adult vaccines. A feature of the legislation that continues to receive widespread attention is the Medicare Drug Price Negotiation Program (MDPNP).

Earlier this year CMS released draft guidance for Initial Payment Applicability Year (IPAY) 2027. This guidance will apply to the negotiation process for 15 drugs, which will occur next year, and the resulting prices will take effect in 2027. As part of the draft guidance, CMS asked respondents how to improve patient input on the MDPNP. The NHC has played a significant role in putting patients voices forward, notably in a Roundtable held in January 2024 with patients and CMS representatives about the effectiveness of the first listening sessions regarding the first ten drugs released under the MDPNP.Below is a summary of the NHC’s comments pertaining to centering patients in the MDPNP negotiation process.

IPAY 2027 Guidance

Improving the Listening Sessions

In January, the NHC held a Roundtable discussion on the 2023 CMS listening sessions with patients, caregivers, patient organizations, and CMS representatives. The goal of this discussion was to develop actionable recommendations to improve future listening sessions impacting the MDPNP. While we appreciate CMS’ efforts to hear directly from patients impacted by the negotiated products and the conditions they treat, the Roundtable discussion highlighted several aspects that could be improved. Key recommendations that came from the discussions included:

• Improving clarity and communication about the intent of the Listening Sessions
• Improving the structure of the Listening Sessions
• Increasing engagement
• Improving speaker experience

A detailed explanation of the recommendations can be found in the NHC report, Amplifying the Patient Voice: Roundtable and Recommendations on CMS Patient Engagement

The NHC appreciates that CMS expressed willingness to build upon prior listening sessions and included potential improvements that were consistent with NHC’s recommendations such as providing clarity of the intent of the sessions and making them more interactive.

In response to the IPAY 2027 draft guidance, the NHC recommends that CMS establish clearer communication about desired outcomes of listening sessions to better equip patients when participating. For instance, CMS could outline the specific aspects of patient experiences and therapeutic alternatives it is interested in, which would enable participants to provide more targeted and relevant input. CMS can also improve the speaker experience in listening sessions by providing accommodations for patients with disabilities and non-native English speakers to ensure that all participants can engage fully. This includes providing translation services, accessible venues, and other necessary supports such as allowing more time to speak, and/or displaying a CMS representative on the Zoom screen for participants to feel they are being acknowledged and heard. CMS should also provide other avenues for patients and other stakeholders to share their feedback with CMS, such as recorded testaments and written statements.

Utilization of Patient Experience Data

The NHC urges CMS to consider a broad range of patient experience data, including both clinical and non-clinical outcomes. Patient-reported outcomes, quality of life measures, and treatment adherence should be represented throughout the negotiation process. The NHC also urges CMS to engage more with patient organizations to identify relevant and pertinent data points to inform its decisions. This will ensure the maximum fair price (MFP) highlights the true value of medications from the patient community’s perspective. The NHC also encourages establishing a feedback loop with patient organizations that will reinforce CMS’ commitment to truly patient-centered care.

Continuous Improvement and Feedback Mechanisms

Echoing sentiments in 2026 IPAY guidance, the NHC strongly supports a robust infrastructure for patient engagement. The creation of a patient ombudsman and regularly held roundtables will ensure the patient community’s voice is being heard throughout the negotiations process and coming from a trusted messenger within CMS.

Data Negotiation Elements for IPAY 2027

As a follow-up to the IPAY 2027 guidance, CMS also released an information collection request (ICR) to seek feedback on their process for external data collection. This included the specific questions they plan to ask various stakeholders to seek their perspective on the negotiated products and the conditions they treat. The NHC appreciates CMS placing more emphasis on patient feedback in data elements as a step in the right direction. The NHC was pleased to see several of our recommendations included in the ICR including: the grouping of questions by respondent type, the inclusion of questions requesting detailed descriptions of what it is like to live with a medical condition by a selected drug/therapeutic alternatives, and the focus on factors that matter most to patients when evaluating the value a drug and alternative.

 At the center of the NHC’s comments was the usability of MDPNP’s questions for patients and their understandability. While questions have been thoughtfully framed, it is essential that the questions are made concise, clear, and accessible for the average person. In stating this, NHC emphasizes that CMS should involve patients directly in the final formatting and phrasing of questions before they are fully implemented into their online portal for solicitation. The CMS should maintain consistent feedback loops with patient organizations to ensure any improvements are aligned with the needs and perspectives of patients.

Finally, NHC encourages CMS to continue refining data submission processes, ensuring patient experience data is given equal weight in determining maximum fair prices.Background: Previous IPAY 2026 Recommendations

After receiving over 7500 comment letters from a variety of stakeholders, CMS released its revised IPAY guidance for 2026 on June 30, 2023. In the revised guidance, CMS acknowledged the importance of expanding patients’ engagement after drug selection, which included structured listening sessions. CMS also incorporated feedback from stakeholders by improving use of patient experience data regarding the negotiations process. CMS specified that patient-reported outcomes, quality of life measures, and treatment adherence data would play a critical role in negotiations. Placing more importance on patient data has enhanced transparency in how CMS integrates patient experiences into pricing decisions. Furthermore, CMS also responded to concerns surrounding communications with patients, by providing guidelines on how patient input will be utilized, which will strengthen data transparency.

Conclusion

To read the NHC’s full comments, click here and here. If you have any questions about the NHC’s comments on the 2027 IPAY guidance or the Data Negotiation Elements for IPAY 2027, please contact Shion Chang, the NHC’s Director of Policy, at schang@nhcouncil.org.