The next round of Medicare drug price negotiations is underway with more Part D medicines soon to be negotiated and federal officials seeking input on how to negotiate Part B drugs.
More Drugs Included in Next Cycle
In May, the Department of Health and Human Services released new draft guidance for the third negotiation cycle, introducing significant changes. For the first time, drugs covered under Medicare Part B, not just those under Part D, will be eligible for negotiation.
Part B drugs are typically more complex and come with a specific set of considerations. While medications covered under the Part D benefit are often picked up at a pharmacy, Part B drugs are administered by a health care provider in an outpatient medical setting. Price-setting talks between manufacturers and the government will determine how much Medicare will pay for medications, which may significantly impact provider reimbursement and ultimately, patient access to provider-administered therapies.
Negotiations are still ongoing for the 15 drugs selected for round two, including for popular obesity treatments, neurological disease therapies and COPD medicines, among others. Final prices for that round are slated to be final by November 2025 and will take effect in January 2027.
Guidance Calls for Broader Participation
According to the draft guidance, CMS aims to place “particular focus on increasing transparency in the negotiation program” after previous rounds generated confusion among many stakeholders. Patients and providers, as well as participants in the pharmaceutical supply chain, have valuable insights to offer policymakers. To that end, CMS is expanding opportunities for public comment.
Stakeholders have been given 60 days to submit comments on the latest draft negotiation guidance for the initial price applicability year, dubbed IPAY 2028. CMS has also committed to considering patient, provider and industry perspectives more systematically.
The public comment period offers a chance for those most impacted to shape the future of how drug prices are negotiated under Medicare. Health care providers and patients should make their voices heard.
Activating Clinicians and Patients in the Process
Since Medicare was given the authority to undertake price negotiations by the Inflation Reduction Act of 2022, the Alliance for Patient Access has worked to ensure patients and providers are part of the conversation. AfPA clinician members have provided testimony in CMS town hall events and the advocacy organization’s leadership has submitted formal comments on behalf of the members and the patients they support.
AfPA also hosted a webinar to explain the public input opportunities to other advocacy partners, encouraging and equipping them to be heard. Additionally, the organization released an advocacy toolkit that organizations and individuals can use to help ensure that negotiators have the information they need to alleviate negative impacts on patients and access to treatments. These efforts reflect a broader commitment to robust, inclusive conversations among stakeholders as the process of drug price negotiations evolves.
The first two years have seen significant changes to how the negotiation program operates. As it continues to expand into Part B medications, stakeholder input is as important as ever. Those who wish to weigh in have until June 26 to submit comments on the draft guidance.
