Medicare Drug Price Negotiation Program for Initial Applicability Year 2026: Key Implementation Dates

Information collection request (ICR) for small biotech exception published with a 60-day notice and public comment period.

Initial guidance for the Medicare Drug Price Negotiation Program initial price applicability year 2026 with a 30-day comment period.
ICR for a small biotech exception submitted to OMB and published with a 30-day notice and public comment period.
ICR on negotiation data elements published with a 60-day notice and public comment period.
ICR for negotiation offer and counteroffer exchange published with a 60-day notice and public comment period.

Time period for total expenditure calculation used in determining negotiation-eligible drugs for initial price applicability year 2026.

Revised guidance for the Medicare Drug Price Negotiation Program initial price applicability year 2026 published.
Deadline for request by a manufacturer of a biosimilar biological product for a delay in the selection of the reference biological product for negotiation due to high likelihood of biosimilar market entry.
Deadline for submission to qualify for small biotech exception for initial price applicability year 2026.
ICR on negotiation offer and counteroffer exchange submitted to OMB and published with a 30-day notice and public comment period.
ICR for negotiation data elements submitted to OMB and published with a 30-day notice and public comment period.

CMS publishes list of 10 Part D selected drugs for initial price applicability year 2026.

Deadline for manufacturers of selected drugs to sign an agreement with the Secretary to conduct negotiations.

Deadline for manufacturers of selected drugs to submit data elements.

CMS sends initial offers of a maximum fair price with a justification to manufacturers; negotiation period begins.

Manufacturer has 30 days from when it receives the offer to propose a counteroffer, if desired.

Negotiation period ends.

CMS publishes maximum fair prices.

Price applicability period begins for selected drugs.

Medicare Price Negotiation: Sponsors Will Have A Say, But Likely Not Sway As Timetable Comes Into Focus