Medicare Drug Price Negotiation 2027: Submission Guidelines & Key Deadlines

Relevant to: Drug Manufacturer Module Enhancements, 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.

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Visit the CMS HPMS website for more information on user access.

Introduction

The Centers for Medicare & Medicaid Services have announced the release of the Negotiation Data Elements and Drug Price Negotiation Process Information Collection Request for the 2027 price applicability year. This initiative under the Inflation Reduction Act 2022 enables negotiations for maximum fair prices on high expenditure, single source drugs in its second cycle. Drug manufacturers need to submit required information by March 1, 2025, through the HPMS website, while public input is also welcomed through specified channels by the same deadline.

Key Dates and Deadlines

The Negotiation Data Elements and Drug Price Negotiation Process information collection request (ICR) form for initial price applicability year 2027 (CMS-10849, OMB 0938-1452) is open for submissions from manufacturers and the public. \n The Inflation Reduction Act (IRA) of 2022 established the Medicare Drug Price Negotiation Program (Negotiation Program) to negotiate maximum fair prices for certain high expenditure,\n single source drugs. For the second cycle of the Negotiation Program, initial price applicability year 2027, CMS selected for negotiation 15 high expenditure, single source drugs covered under\n Part D. \n Manufacturers of selected drugs that sign an Agreement with CMS must submit their\n information through the CMS Health Plan Management System (HPMS) website by March 1,\n 2025. \n Members of the public may optionally submit evidence about the selected drug and their\n alternative treatments by March 1, 2025 via the following web link:\n https://hpms.cms.gov/app/ng/pblc_cmt/.

PACE Compliance

This memo is particularly important to PACE programs as it outlines compliance requirements for drug price negotiations under the Inflation Reduction Act (IRA) of 2022. The Act introduces a Negotiation Program aimed at negotiating maximum fair prices for certain high expenditure, single source drugs. It is crucial for PACE programs to be aware of these requirements as participation might impact drug pricing and availability.

Manufacturers of the drugs selected for this program must adhere to specific compliance requirements:

1. Manufacturers must register and submit their negotiation information through the CMS Health Plan Management System (HPMS) by March 1, 2025. This step is critical to ensure their participation in the negotiation process.

2. Compliance involves providing data elements as stated in the information collection request form (CMS-10849, OMB 0938-1452).

Failure to comply with these submission requirements may result in non-compliance penalties or exclusion from the program. Therefore, it is essential for PACE programs involved with these drugs to closely follow the guidelines and deadlines set forth by CMS.

Required Actions

1. Submit information through the CMS Health Plan Management System (HPMS) by March 1, 2025, if you are a manufacturer of a selected drug and have signed an Agreement with CMS.

2. Ensure you are registered for access to the CMS HPMS if you are a manufacturer. For guidance on the registration process, visit the CMS HPMS user access page.

3. Members of the public may submit evidence about selected drugs and alternative treatments via the provided web link by March 1, 2025.

FAQs

  • “What is the Medicare Drug Price Negotiation Program?”
  • “How can drug manufacturers submit information for price negotiation?”
  • “What are the requirements for registering with the CMS Health Plan Management System?”
  • “What is the deadline for submitting negotiation data to CMS?”
  • “How can the public submit evidence about selected drugs?”

Visit the CMS HPMS website for more information on user access.

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