The Centers for Medicare & Medicaid Services wants earlier and more flexible communication with drugmakers during the next round of Medicare negotiations, it announced Wednesday.
The first round of negotiations closed in August and are expected to save Medicare $6 billion in 2026. The next round will include up to 15 drugs, with negotiated prices taking effect in 2027.
However, several drug developers have complained that the process was not transparent or objective, in addition to opposing the law overall.
CMS said on Wednesday in a regulatory document that it listened to public feedback, and plans to engage companies earlier during the next cycle of negotiations. Next year’s process will also allow additional opportunities for drugmakers and the agency to submit new offers and counteroffers, a CMS official said during a press call.
“We are continuing to implement the prescription drug law thoughtfully, prioritizing engagement with all interested parties, and ensuring the process is as transparent and inclusive as possible,” Meena Seshamani, CMS deputy administrator and director of the Center for Medicare, said in a news release announcing the change.
CMS will select the next round of drugs for negotiation by Feb. 1, 2025. Like this year, the agency will propose an initial offer and host up to three negotiation meetings with participating drugmakers. But this time, the first negotiation session will occur before the deadline for companies to file a counteroffer. After that, both CMS and drugmakers will have opportunities to file additional offers or counteroffers over a three-and-a-half month period before the government makes its final offer.
The agency highlighted other revisions in the final guidance, including plans to consult more patients and clinical experts outside of the pharmaceutical industry. The agency said it will hold up to 15 patient-focused discussions this spring while it puts together initial offers for selected drugs. CMS hosted 10 patient listening sessions in 2023.
“These events are intended to share patient-focused input on topics such as patient experience, therapeutic alternative(s) to the selected drugs, the extent to which the selected drugs address unmet medical need, and the impact of selected drugs on specific populations,” CMS said in a fact sheet accompanying the update.
Companies will have until the end of February to decide if they are participating in negotiations, kicking off the process. Those who decide not to participate risk losing Medicare and Medicaid coverage altogether or facing a steep fine. CMS will make initial price offers on participating drugs by June 1.