HHS Announces Timeline for Medicare Drug Price Negotiation

On Wednesday, the U.S. Department of Health and Human Services announced its timeline for the Medicare Drug Price Negotiation Program, a key point of legislation in the Inflation Reduction Act (IRA).

In a press call, Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure said that the department will spend the coming months collecting public feedback from industry stakeholders and advocates. The list of the ten negotiated drugs will then be announced on September 1. Then, Medicare will negotiate with manufacturers and the new prices will be published in 2024 for implementation in 2026 and in future years, the prices of additional medications will be negotiated in accordance with the IRA.

HHS Secretary Xavier Becerra explained that as of January 1, all Medicare beneficiaries should have their insulin costs capped at $35 per month. If beneficiaries are charged more under Medicare Advantage plans, HHS has arranged for caps to go into effect on March 31. Also, vaccines like the shingles vaccine are available to beneficiaries at no cost.

Drug companies are also now required to rebate any extra charge beyond the cost of living adjustment (COLA) of inflation. The first rebate period began in October 22 for Medicare Part D and the second, for Part B, began on the first of the year, the HHS press release explains.

From Secretary Becerra:

The Inflation Reduction Act is one of the most consequential health care laws since the Affordable Care Act. And having signed it into law, the President is now delivering on lower prescription drug costs and he’s been able to help make insurance more affordable. At the end of the day, that is good for the pocketbook of hundreds of millions of Americans and it’s good for the U.S. economy as well.

Dr. Meena Seshamani, M.D., Ph.D., Director of Medicare, urged industry partners to engage with upcoming requests for feedback  including monthly technical calls, strategic policy meetings, roundtables and other feedback forums.

It’s crucial that the public knows when and how they can make their voices heard on these important endeavors, and it is a key pillar to the work that we are doing with the implementation of the Inflation Reduction Act.

It’s clear that the agency will rely on public feedback for determining the drugs for negotiation. While the IRA specifies that the list must include brand-name drugs without generic equivalents, the criteria for selection has yet to be determined. As Health Affairs notes, they could be based on quality-adjusted life years, the value of a statistical life, clinical effectiveness, or systemic methods like multi-criteria decision analysis (MCDA) or social return on investment (SROI).

The U.S. Food and Drug Administration also published a summary of the drug therapy approvals made in 2022. These included therapies for heart, blood, and kidney disorders as well as type 1 and 2 diabetes, and autoimmune, inflammatory and lung diseases.

The full timeline and summary of the Medicare Drug Price Negotiation Program can be found at CMS.