Medicare Drug Price Negotiation for 2028 Initial Price Applicability Year

The Centers for Medicare & Medicaid Services (CMS) announced an opportunity for the public to comment on CMS' intention to collect information on “Drug Price Negotiation for Initial Price Applicability Year 2028 under Sections 11001 and 11002 of the Inflation Reduction Act Information Collection Request” (CMS-10849, OMB 0938-1452). The package contains two parts: 1) the Negotiation Data Elements Form, which includes the data CMS will consider as the basis for determining offer(s) and counteroffer(s) throughout the negotiation and renegotiation (if applicable) processes based on the submissions required from a participating drug company and the optional submissions from the public on the selected drug and its therapeutic alternative(s), and 2) the Drug Price Negotiation Process Form, which includes the data and information CMS will consider if a participating drug company submits a counteroffer for a selected drug during the negotiation and renegotiation (if applicable) processes. Members of the public may submit evidence about therapeutic alternatives to the selected drugs via through CMS.gov. 

Comments must be received by August 29, 2025.