The Chronic Care Policy Alliance (CCPA) is continuing to advocate for policies that prioritize patient needs and ensure their voices are heard. Recently, CCPA was joined by 21 organizations in a group letter and submitted an individual comment letter to the Centers for Medicare and Medicaid Services (CMS) advocating for patient involvement within the Medicare Drug Price Negotiation Program (MDPNP). These letters emphasize the importance of patient voices and access to equitable treatment and medications. Below are the two letters detailing our recommendations:
Group Letter led by CCPA:
Dear Dr. Seshamani,
We are patient organizations who collectively represent a wide range of patients living with chronic diseases. For patients, access to treatments is critically important. Treatments can improve daily life, minimize debilitating pain and extend or save lives. However, policies that may affect access to treatments, such as changing incentives for including a treatment on a formulary, mean that patient who would be most affected by the change should have the greatest voice in the matter. We strongly believe that health care policies should be patient-centered, not simply made based on financial considerations. That is why we believe that patient voices must be included throughout the process of the Medicare Drug Price Negotiation Program (MDPNP).
As the MDPNP enters its second cycle of treatment selection and negotiation, we urge CMS to ensure patients have a seat at the table. Last year numerous patients and patient organizations provided input on treatments selected for negotiation through written comments and participating in listening sessions. While we appreciate CMS providing these opportunities, many patient voices felt they had more to contribute to this process but lacked the opportunity to be fully heard. Additionally, patients were concerned that the process was lacking in privacy and therefore were not comfortable going into specific details about their health. These factors deterred patients from participating fully and honestly in the negotiation process. We urge CMS to both improve and expand these opportunities to foster greater dialogue, input, and participation from all voices.
We offer three recommendations:
- Requirements for written comments should be less structured to allow a wider range of comments. Please understand that each patient’s story, experience and ability vary widely. The written comment process in the first negotiation cycle was cumbersome, time consuming and forced comments into pre-determined and awkwardly defined frameworks. This resulted in advocates feeling their input was not valued, with important points being left out because there was not a clear avenue to fully express them, and discouraged patients from participating at all due to the complexity of the process
- Listening sessions should promote dialogue between CMS and stakeholders. The listening sessions conducted in the first cycle were an important opportunity to provide direct feedback to CMS; however, the lack of dialogue and overly rigid structure diminished their usefulness and the perception that the comments were “heard.” In future listening sessions, we recommend a roundtable style that allows stakeholders to directly engage with each other and CMS – this will help elucidate patient concerns. CMS should also consider having separate roundtables for different stakeholder types – patients, their advocates, providers, and others – to give stakeholders more comfort in expressing their views by having a less intimidating forum. We do not believe that any voices should be diminished through this process and increased engagement from all stakeholders will only help elevate the primacy of the patient in this process. Additionally, CMS should consider offering both virtual and in-person options, holding regional discussions using its regional staff around the country, and varying the times that sessions are held to accommodate time zones and work schedules of the varied stakeholders CMS seeks to engage. Further, offering recorded and non-recorded options may help even more patients feel comfortable providing feedback.
- Beyond the listening sessions, patients should be consulted throughout the negotiation process. Patients have a clear interest in ensuring that the negotiation process does not have unintended consequences, such as losing access to treatments because of changes in formulary coverage for both negotiated and non-negotiated treatments. CMS should regularly convene meetings with patient organizations and other stakeholders to brief them on the negotiation process, hear feedback and concerns about access to treatments, and provide a means to resolve and address those concerns. Access to treatment and medication is paramount for patients – the potential for new barriers to access, like greater prior authorization requirements, step therapy, or other hurdles, must be zealously guarded against as a negative consequence of the negotiation process.
We look forward to engaging with CMS as the second cycle of negotiation moves forward.
Should you have any questions or comments, please contact Liz Helms, Founder and Director, CCPA at lizh@chroniccarealliance.org. Thank you for your time and attention to these critical issues.
Sincerely,
Chronic Care Policy Alliance
AiArthritis
Albie Aware Breast Cancer Foundation
Alliance for Aging Research
American Senior Alliance
Arizona Chronic Care Together (ACT)
Axis Advocacy
Bay Area Cancer Connections
California Access Coalition
California Black Health Network
California Chronic Care Coalition
California Health Collaborative
California Hepatitis C Task Force
Carrie’s TOUCH
Chronic Disease Coalition
Healthy Men Inc.
HIV+Hepatitis Policy Institute
Looms For Lupus
Neuropathy Action Foundation
Nevada Chronic Care Collaborative
Partnership to Fight Chronic Disease
The National Puerto Rican Chamber of Commerce
CCPA comment Letter:
Dear Dr. Seshamani,
The Chronic Care Policy Alliance (CCPA) is a network of state and regional advocacy organizations advancing public policy that improves the lives of those living with chronic conditions and diseases. In recent years, CCPA has advocated in the interests of these patients for issues related to prescription treatment access and reducing out-of-pocket costs under the Inflation Reduction Act (IRA), as well as through supporting efforts to ensure patients benefit at the pharmacy counter, by urging reforms for Pharmacy Benefit Managers and supporting prohibiting copay accumulator programs within insurance plans, that drive up out-of-pocket costs for patients.
CCPA appreciates CMS releasing a draft Guidance Memorandum for the 2026 Program Year of the Medicare Drug Price Negotiation Program (MDPNP). We were pleased to comment on last year’s draft guidance and are grateful that CMS took some of CCPA’s comments to heart, by adding opportunities for patient input through written comments and listening sessions. While not all of our concerns were addressed and improvements to the patient input process are greatly needed, we hope to contribute to continued improvement of the MDPNP that supports patient-centered health care policies and patient access to treatments.
1. Ensuring Patients Have a Seat at the Table and Patient Voices Are Heard
Recently, CCPA joined with 19 other patient organizations in sending a letter to CMS outlining how patients can be more involved in the negotiation process, including by broadening the written comments and listening sessions, as well as engaging in ongoing dialogues with patient organizations. We incorporate those recommendations here by reference and our letter is attached.
As with the implementation of any new program, there are lessons learned from the first year that can support improvements in subsequent years. As noted in the stakeholder letter, the rigid structure of the written comments and narrow focus of the listening sessions left many patients and patient advocates feeling that they were not fully heard. We hope that CMS will strive to address this in future opportunities for patient input.
Regarding the specific patient-focused events referenced in Section 60.4, CCPA welcomes this focus on patient input and hopes CMS will implement an “all of the above” strategy to hear from patients and all stakeholders in as many forums and events as possible. Recognizing that many patient organizations are state-based (and not based in the Washington, DC region), providing options for virtual participation is important. It is also important to seek out and include groups beyond only large national organizations, as smaller advocates have real contributions to make but not the same ability or resources to track and engage with all federal policymaking opportunities. To that end, CMS should consider hosting virtual and in-person events to accommodate patient advocates around the country. CMS could host regional events using its local staff. Providing both recorded and non-recorded opportunities to speak will also give more patients greater comfort in commenting and expressing themselves without fear of overexposing their personal information or making themselves a focal point for a topic. Recognizing that many patients and providers may not have flexibility in their work schedules or the ability to take time off during the typical office hours, we also encourage CMS to vary the times of day that events are held to accommodate these limitations and encourage more robust participation from patients and physicians alike – those with the real-world knowledge about the use and importance of the medications under review.
Additionally, CCPA supports allowing dialogue and discussion between participants and CMS, to promote greater understanding and appreciation of different perspectives. One option may be to host roundtables for different types of stakeholders – patient groups, providers, and others – so that similar stakeholders can offer their perspectives together, without feeling intimidated by other stakeholders. For example, the discussion a patient advocate forum would be much different than the likely more scientific and medically focused discussion a group of physicians and other providers would have. CCPA supports expanded discussions with any patients living with disease or conditions of the medications under review, rather than limiting or putting emphasis on those that are currently receiving the individual treatment, since there is a high likelihood of patients having used or needing that particular treatment in the future. All groups and voices, regardless of their background, mission, or perspective, should have a seat at the table. We hope all stakeholders will focus on evaluating the arguments presented, as we collectively strive to achieve our shared goal of improving patient care.
2. Valuing All Patients
As noted in the draft Memorandum in Section 50.2, the law prohibits CMS from using research that “treats extending the life of an individual who is elderly, disabled, or terminally ill as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.” CCPA and other advocates have long opposed efforts to value some patients over others – whether that is in the form of Quality Adjusted Life Years (QALYs) or metrics, all patients deserve to be treated fairly, equally, and with respect to their needs and wishes. We appreciate CMS making clear in its Memorandum that this data, in accordance with the law, will not be included, and encourage CMS to further protect against similar quality metrics that would have the same harmful impact on patients. CCPA urges CMS to find all possible avenues for further strengthening these protections for patients as it considers multitudes of research and data on treatments.
Additionally, in looking at comparative effectiveness research, CCPA urges CMS to see patients as unique individuals, and not an aggregated group. A treatment that works for many patients may not work for others or might be the only option that works for another – aggregating many patients undermines the value a treatment provides to each individual. Because of this, we believe that comparative effectiveness research may not be the right means of assessing value, and we encourage CMS to hear from patients on the unique value a medication provides to them, in supporting their wellbeing and quality of life, and making judgments of value based on those individual stories. Patients fear that this process will result in them losing access to their preferred medications, especially if plans prioritize negotiated products over non-negotiated products. Incorporating individual patient experiences into a product’s value proposition will ensure a negotiated price that accurately reflects the benefit to each patient, without compromising access.
Finally, CCPA welcomes CMS seeking to improve the data collection process from patients through a forthcoming Information Collection Request (ICR) on Negotiation Data Elements and Drug Price Negotiation Process ICR for initial price applicability year 2027. We look forward to providing comments when that document is released. In the meantime, as mentioned in the multi-organization letter to CMS (attached), last year’s process for submitting stakeholder organization and patient information was difficult to navigate, with comments shoe-horned into prescriptive frameworks. We urge CMS to allow for broad comments that allows patients and their advocates to share their unique experience – by granting them the ability to give the kind of broad comments CMS regularly collects through Notice and Comment rulemaking.
3. Protecting Patient Access to All Medications
In addition to emphasizing greater patient input and valuing all patients, we urge CMS to proactively establish clear and concrete policies to protect patient access to treatments, especially in light of formulary changes that prioritize negotiated or non-negotiated treatments over other products. CCPA appreciates the discussion in Section 110 on Part D formularies and the reiteration of current policies meant to protect patient access and medical decision-making. CCPA strongly believes that health care policies should not prioritize financial savings over patients; in reducing the price for certain medications, patients risk having access to more expensive products deprioritized (even if the other product is potentially a better treatment for them); likewise, patients may face new barriers, such as new prior authorization requirements, step therapy, or other utilization management hurdles, to accessing non-negotiated products. CMS must ensure that patients retain the same level of access to all products as was available before the MDPNP and the selection of specific treatments for negotiation. In implementing Section 110 and protecting patient access to prescription products, CCPA urges CMS to proactively implement policies that would protect patients from increased barriers to care, create specific opportunities for patient feedback, and ensure robust monitoring and complaint resolution process to address issues as they arise.
4. Conclusion
We thank you for receiving comments on this matter and we hope to continue an ongoing dialogue with the agency throughout this second cycle of the MDPNP.
Sincerely,
Liz Helms
Founder/Director
Chronic Care Policy Alliance
1001 K St.,. 6th Floor
Sacramento, CA 95814
www.chroniccarealliance.org