Key facts
- CMS is proposing to codify and strengthen the Medicare Drug Price Negotiation Program.
- The changes aim to prevent drugmakers from exploiting loopholes to avoid price negotiations.
- The proposal addresses a loophole where altering a drug's formulation could make it ineligible for negotiation.
- New rules would require that products with the same active ingredient be considered for negotiation if owned by the same license holder.
- The codified rules would direct negotiations starting in 2029.
- A 60-day public comment period on the proposed rule will close on August 17, 2026.
The Centers for Medicare and Medicaid Services (CMS) has put forth a proposal to codify and strengthen the Medicare Drug Price Negotiation Program, established by the Inflation Reduction Act. Currently operating under nonbinding guidance documents, the program's requirements would be formalized into federal rules, making them more difficult to challenge. These codified rules are slated to direct negotiations beginning in 2029.