Medicare Drug Price Negotiation: 2028 Initial Price Applicability & Information Collection Request
Relevant to: OEC, Enrollment and Payment Systems, Drug Pricing
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 complete memo from CMS.
Introduction
The Centers for Medicare & Medicaid Services (CMS) has announced a new information collection request named the Negotiation Program Drug Selection ICR. This initiative, falling under the Inflation Reduction Act, aims to gather input on drug price negotiations for the year 2028. It includes provisions like the Small Biotech Exception and Biosimilar Delay, essential for manufacturers aiming to qualify or delay their drug’s eligibility for price negotiation. All submissions are due by July 14, 2025, through the CMS Health Plan Management System.
Key Dates and Deadlines
- Date of the memo: May 13, 2025
- Comments deadline for the Drug Selection ICR: July 14, 2025
- Initial price applicability year for selected drugs: 2028
PACE Compliance
This memo is relevant to PACE programs in terms of compliance with the drug negotiation process as outlined by the CMS. Participating manufacturers must utilize the CMS Health Plan Management System (HPMS) to submit information related to drug negotiation eligibility for either the small biotech exception or a biosimilar delay.
Plans participating in PACE need to ensure:
- All related drug information and requests for exceptions or delays must be submitted via the HPMS platform, as per CMS guidelines.
- Manufacturers looking for a renegotiation-eligible drug status must submit the required details through the designated Box folder that CMS provides for each selected drug.
- Submissions must comply with the section specifics of the Inflation Redaction Act Information Collection Request, referred to as the “Drug Selection ICR.”
- All submissions are due by July 14, 2025, ensuring they are complete and accurate to avoid non-compliance issues.
Being compliant in these aspects helps maintain proper status and eligibility within the Medicare programs, avoiding submission suppression or penalties.
Required Actions
1. Review the “Negotiation Program Drug Selection for Initial Price Applicability Year 2028” information collection request published in the Federal Register and on the CMS PRA website.
2. Submit comments regarding the information collection request by the deadline of July 14, 2025.
3. For manufacturers requesting a small biotech exception or biosimilar delay, submit your information through the CMS Health Plan Management System (HPMS) website as per the provided instructions.
FAQs
- “What is the Medicare Drug Price Negotiation Program?”
- “How can manufacturers apply for the Small Biotech Exception?”
- “What is the process for requesting a Biosimilar Delay?”
- “How do manufacturers submit information for renegotiation-eligible drugs?”
- “Where can I find the full text of the Drug Selection Information Collection Request?”
