On Wednesday, August 23, 2023 CCPA sent the following letter to the Centers for Medicare and Medicaid Services (CMS) regarding the implementation of the Medicare Drug Price Negotiation Program (MDPNP):
Meena Seshamani, M.D., Ph.D.
Deputy Administrator and Director of the Center for Medicare
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
RE: Implementation of Listening Sessions Under Medicare Drug Price Negotiation Program: Revised Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026
Electronically Submitted via
IRARebateandNegotiation@cms.hhs.gov
Dear Dr. Seshamani,
I am writing in regard to the revised guidance on the Centers for Medicare and Medicaid Services’ (CMS) implementation of the Medicare Drug Price Negotiation Program (MDPNP), released on June 30, 2023, and CMS’s revision adding upcoming listening sessions to the process.
Thank you for taking into account the comments of Chronic Care Policy Alliance (CCPA) and other organizations who emphasized that patient voices must be part of the process. CCPA specifically recommended for CMS to hold listening sessions to hear directly from patients. (See attached copy of CCPA’s comment letter.) We appreciate that CMS took these recommendations into consideration and revised the guidance to add listening sessions after the October 2, 2023, deadline for the submission of materials on selected products in CMS’ negotiation process. As we previously stated, patient testimonials “are not anecdotes replacing data – these are patients speaking truth to power.”
Patient voices come in all forms – some are well-organized and have a national presence, others are centered on their state and community, and sometimes individuals work alone as passionate patient advocates. CCPA’s network of advocates brings together all of these voices – and the listening session process should be broadly structured to ensure all these perspectives are heard.
As CMS formulates how these listening sessions will work, CCPA would like to provide its guidance and perspective. Our core principle for this endeavor is that CMS should maximize opportunities for patient comment, and those comments must be incorporated into the process — listening sessions should be part of a dialogue with meaningful influence, not simply a venue for listening without action.
During the creation and implementation of the Affordable Care Act, I participated in listening sessions hosted by the Department of Health and Human Services (HHS), through my work with the California Chronic Care Coalition. I thought highly of the Department’s handling of those public listening sessions, conducted to inform and in preparation for creating the Affordable Care Act, and I believe they are a useful model to apply to implementation of the IRA. We recommend the following principles and parameters for these listening sessions:
- Logistical details about the listening sessions should be provided at least 2 weeks prior to the October 2, 2023 deadline.
- Regional listening sessions should be held in all 10 CMS regions for patients to present their comments.
- Listening sessions should be open to the public, and not invite-only, with publicly available sign ups and live viewing.
- Listening sessions should be publicized by CMS, including through using existing CMS channels, such as email lists and other resources they have available.
- Listening sessions should allow for comments from both stakeholder organizations and members of the general public.
- Listening sessions should allow for presentations and submission of additional materials.
- Presenters should be allowed reasonable time to present.
- The listening sessions should be hosted virtually to allow for maximum attendance across each region.
- State and local organizations should be sought for participation, not just national organizations, and,
- Listening sessions should be a dialogue, with opportunities for an exchange of perspectives between CMS and patients.
Individuals, particularly patients, should have the opportunity to comment on the totality of the drug negotiation program, including how changes in price may affect access and ongoing research for that product. CMS must consider how its actions on one product ripple throughout the health care system to directly affect patients and the medication development ecosystem. Patients wait for breakthroughs, fundraise to support research, and require existing and new medications to continue living or thriving. This is not a price game for patients, it is survival.
CCPA would welcome the opportunity to continue a dialogue with CMS on how to maximize patient engagement under the MDPNP and stands ready to serve as a resource and be a thought partner for a patient-centered implementation of the IRA.
While we were disappointed that CMS did not take stronger action in response to other comments included in CCPA’s comment letter, particularly around protecting patients from formulary changes under Part D plans for negotiated and non-negotiated drugs, we look forward to continuing to provide feedback to CMS as implementation moves forward.
We urge CMS to be vigilant in preventing unintended consequences from the implementation of the MDPNP, especially on Part D plan formulary changes and other restrictions on utilization management that will disrupt patient access. Patients should not be disadvantaged nor face new barriers to accessing negotiated and non-negotiated medicines.
As CMS prepares for the next program year, we hope CMS will solicit feedback on its program guidance annually.
For patients, health care policies should not be made “about us, without us” – patients must have a seat at the table and have their voices heard. Again, thank you for expanding opportunities for patient input through revising the guidance to include listening sessions. We hope that many patient voices across the country will have the opportunity to be heard through this process.
Sincerely,
 |
| Liz Helms Founder/Director Chronic Care Policy Alliance 1001 K ST. 6th Floor Sacramento, CA 95814 www.chroniccarealliance.org |