# 2026-22792: Medicare’s Drug Price Negotiations Get Another Dense Federal Rule 2026-22792, Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program, is a Federal Register rule from Health and Human Services Department, Centers for Medicare & Medicaid Services published 2026-11-09, effective 2026-12-05; deemed significant under Executive Order 12866; PRIA reads it as touching household money (as of 2026-11-11). - Canonical: https://policyrisk.com/federal-register/2026-22792 - As of: 2026-11-11 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-22792 - Title: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program - Type: Rule - Agencies: Health and Human Services Department; Centers for Medicare & Medicaid Services - Citation: 91 FR 72176 - Published: 2026-11-09 - Effective: 2026-12-05 - Comments close: not stated - Significant: yes (OIRA_API) - Touches household money: yes - Regulation identifier numbers: 0938-AV90 - Last updated: 2026-11-11 ## In one line Medicare’s Drug Price Negotiations Get Another Dense Federal Rule ## Summary Starting in 2029, Medicare will negotiate drug prices to help lower costs for people using Medicare Part D. This new rule, effective December 5, 2026, sets clear policies to make prescription drugs more affordable and fair. If you or a loved one uses Medicare for prescriptions, expect some savings and changes in how drug prices are set. ## Abstract This rule finalizes and codifies the Medicare Drug Price Negotiation Program ("Negotiation Program") and establishes certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Program ("Part D Program") as required by the Inflation Reduction Act of 2022. This final rule also finalizes a proposed policy for specific fixed combination drugs that are new formulations. ## Effects PRIA read - Rule goes into effect December 5, 2026: benefit, medium. The rule is effective December 5, 2026. The Negotiation Program rules in this final rule apply beginning with initial price applicability year 2029, and Part D Program coverage changes begin January 1, 2029. - Medicare will negotiate drug prices starting 2029: benefit, medium. Starting with initial price applicability year 2029, Medicare will negotiate maximum fair prices (MFPs) for selected high-expenditure, single-source drugs. The Secretary will select up to 20 drugs covered under Part D or payable under Part B (or both) for initial price applicability year 2029 and s… - Negotiated prices already applied for selected drugs in prior years: benefit, medium. The Secretary previously selected 10 drugs for negotiation with MFPs that took effect in initial price applicability year 2026, selected 15 drugs for initial price applicability year 2027, and selected 15 drugs for initial price applicability year 2028. One drug was selected for renegotiation for i… - Federal spending effects through 2031: mixed, medium. CMS states the effects of the Inflation Reduction Act and these policies are to reduce government expenditures for Medicare Part B, to increase Part D expenditures through 2030, and to decrease Part D expenditures beginning in 2031. - Temporary Floor for Small Biotech Drugs (2029–2030): mixed, medium. CMS finalizes how it will implement a Temporary Floor for Small Biotech Drugs on the maximum fair price for initial price applicability years 2029 and 2030, including a modified approach when certain ceiling amounts are below that Temporary Floor. - How one-time Part B drugs get a 30‑day equivalent: mixed, low. CMS finalized policies explaining how it will calculate a 30-day equivalent supply for selected drugs or therapeutic alternatives payable under Medicare Part B that are typically administered one time (for example, some vaccines, gene therapies, and cancer therapies). - Policy for specific fixed combination drug formulations: mixed, low. CMS finalized a policy for certain fixed combination drugs that it determines are new formulations: when products with the same NDA/BLA holder differ because an included active moiety/ingredient/antigen creates a new formulation and enables an alternative route of administration, CMS will identify… - When former orphan drugs become eligible: mixed, low. CMS finalized a clarification of how it will identify the day from which to measure the 7‑ and 11‑year approval/licensure periods for drugs that formerly qualified for the Orphan Drug Exclusion, affecting when such drugs are considered for negotiation eligibility. - CMS review of ‘Bona Fide Marketing’ for generics/biosimilars: mixed, low. CMS finalized the process and schedule by which it will review information to determine whether the manufacturer of an approved generic drug or licensed biosimilar is engaged in ‘‘Bona Fide Marketing’’ of that product, as defined in the rule. ## Related documents - [2026-22812](https://policyrisk.com/federal-register/2026-22812): Medicare and Medicaid Programs; Cutting Administrative Requirements for Excellence in Patient Care, 2026-11-10 - [2026-22743](https://policyrisk.com/federal-register/2026-22743): Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage…, 2026-11-09 - [2026-22750](https://policyrisk.com/federal-register/2026-22750): Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the E…, 2026-11-09 - [2026-22739](https://policyrisk.com/federal-register/2026-22739): Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; i…, 2026-11-06 - [2026-22381](https://policyrisk.com/federal-register/2026-22381): Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage, 2026-11-03 - [2026-22194](https://policyrisk.com/federal-register/2026-22194): Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury (AKI) Dialysis Paym…, 2026-10-30 ## Sources - [2026-22792 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/09/2026-22792/medicare-drug-price-negotiation-program-and-medicare-prescription-drug-benefit-program) - [2026-22792 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-09/pdf/2026-22792.pdf) ## Related - [Previous: 2026-22788, National Emission Standards for Hazardous Air Pollutants: Polyvinyl Chloride an…](https://policyrisk.com/federal-register/2026-22788) - [Next: 2026-22793, Extension of the Suspension of Expansion of End-User Controls for Affiliates of…](https://policyrisk.com/federal-register/2026-22793) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-22792 (as of 2026-11-11).