CMS 2025 Drug Price Negotiation Program Details for Manufacturers and Public Submissions
Relevant to: Enrollment and Payment Systems, Drug Pricing, Part D
Each week, we scan the latest CMS memos to find the most important ones that apply for PACE programs. Below is a summary of what you need to know.
Disclaimer: The content provided on this site is a summary for informational purposes only, and Grane PBM, Inc. assumes no liability for any errors or omissions in the site’s content. The information does not constitute legal or regulatory advice or replace the original CMS memo. Readers are advised to consult the CMS memo in its entirety and to verify information independently before making any decisions based on this information.
Click here to read the full memo from CMS.
Introduction
Recent updates from CMS highlight the Medicare Drug Price Negotiation Program, focusing on the initial price applicability year 2027. The program, formed under the Inflation Reduction Act of 2022, aims to negotiate fair prices for selected high-expenditure, single-source drugs. Manufacturers and the public can submit necessary data and evidence through the HPMS by March 1, 2025.
Key Dates and Deadlines
- Date of Memo: January 30, 2025
- Submission Deadline for Manufacturers: March 1, 2025
- Public Evidence Submission Deadline: March 1, 2025
PACE Compliance
The memo highlights requirements related to the submission of data for the Medicare Drug Price Negotiation Program’s second cycle, which is relevant for PACE programs. PACE programs may be affected by this memo if they utilize or plan to utilize drugs that are part of the Medicare Drug Price Negotiation Program.
In order to comply with the stipulations of this memo:
- Drug manufacturers involved in the PACE program must ensure that they are registered with the CMS Health Plan Management System (HPMS) and submit the necessary information by the March 1, 2025 deadline.
- It is crucial for manufacturers to adhere to the guidelines set forth by CMS to maintain compliance and avoid potential penalties or restrictions. Adherence can involve timely data submission and cooperation with the monetary and operational aspects of drug pricing negotiations.
Further guidance on HPMS registration and submission processes should be closely followed as outlined by the CMS, particularly for drugs that show a significant expenditure impact within PACE programs.
Required Actions
1. Manufacturers of selected drugs must register for access to the CMS Health Plan Management System (HPMS) if not already registered.
2. Submit required information through the HPMS website by March 1, 2025.
3. Members of the public can optionally submit evidence regarding selected drugs and alternative treatments by the same deadline using the public comments web link.
FAQs
- “What is the Medicare Drug Price Negotiation Program?”
- “Which drugs are selected for negotiation in 2027?”
- “How do drug manufacturers submit their information to CMS for price negotiation?”
- “What is the deadline for submitting information for the 2027 negotiation cycle?”
- “Can the public participate in the drug price negotiation process?”
