Because of this new law, Medicare will be able to negotiate directly with drug manufacturers to lower the price of some of the costliest single-source brand-name Medicare Part B and Part D drugs.

Medicare Drug Price Negotiation Program: Next Steps in Implementation for 2026

Drug Price Negotiation Timeline for 2026

Medicare Drug Price Negotiation Program Initial Guidance

Fact Sheet: Medicare Drug Price Negotiation Program Initial Guidance

Information Collection Requests (ICRs)

Data Negotiation Elements initial ICR can be found in the Federal Register. The full text of the ICR can also be found here. Comments are due by May 22, 2023 and can be submitted at Regulations.gov.  

Drug Price Negotiation Process initial ICR can be found in the Federal Register. The full text of the ICR can also be found here. Comments are due by June 20, 2023 and can be submitted at Regulations.gov. 

Small Biotech Exception ICR can be found in the Federal Register. The full text of the ICR can also be found here. Comments are due by May 24, 2023 and can be sent to https://www.reginfo.gov/public/do/PRAMain.