Federal Register #CMS-2026-2080

CMS Proposed Rule: Medicare Drug Price Negotiation Program Implementation

This opportunity centers on a proposed regulatory rule from the Centers for Medicare & Medicaid Services (CMS) to implement the Medicare Drug Price Negotiation Program as required by the Inflation Reduction Act of 2022. - Government Buyer: - Department of Health and Human Services (HHS) - Centers for Medicare & Medicaid Services (CMS) - No specific Original Equipment Manufacturers (OEMs) or commercial vendors are named in the rule or attachments - Products/Services Requested: - No procurement of products or services is requested; the rule establishes a regulatory framework - The rule targets high-expenditure, single-source drugs and biologics for annual selection and negotiation of maximum fair prices (MFPs) under Medicare Part B and Part D - Approximately 20 drugs will be selected annually for negotiation, with an additional 15 eligible for renegotiation based on new indications, monopoly status changes, or other material factors - Unique/Notable Requirements: - Codifies procedures for drug selection, negotiation, and renegotiation - Establishes compliance requirements and civil monetary penalties for manufacturers - Modifies fixed combination drug policies and clarifies orphan drug exclusions - Implements a Temporary Floor for Small Biotech Drugs for specific years - Requires Part D plan sponsors to include selected drugs with negotiated MFPs on formularies, with limited exceptions - No part numbers, purchase quantities, or specific product/service requests are included, as this is a regulatory action rather than a procurement

Description

This proposed rule aims to codify the Medicare Drug Price Negotiation Program and establish new policies for both the Negotiation Program and the Medicare Prescription Drug Benefit Program as mandated by the Inflation Reduction Act of 2022. It includes modifications to the fixed combination drug policy and outlines procedures for drug price negotiations, including definitions, eligibility, and pricing methodologies. The rule also addresses the implementation of the Temporary Floor for Small Biotech Drugs and clarifies policies related to off-label use and renegotiation eligibility. Comments on the proposed rule must be received by August 17, 2026.

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