CMS publishes final rule implementing mandatory GLOBE Model

Cresthaven AnalyticsIntelligence Brief

Headline

CMS publishes final rule implementing mandatory GLOBE Model for Medicare Part B drug pricing effective November 30

Executive Summary

CMS published a final rule on October 2, 2026, implementing the Global Benchmark for Efficient Drug Pricing (GLOBE) Model under section 1115A of the Social Security Act. The rule establishes a mandatory Medicare payment model that tests an alternative method for calculating Part B drug inflation rebate amounts for certain separately payable drugs and biological products. It takes effect November 30, 2026.

Bottom Line

The CMS final rule establishes the GLOBE Model as a mandatory Medicare payment model effective November 30, 2026, testing an alternative method for calculating inflation rebate amounts for certain separately payable Medicare Part B drugs and biological products under Original Medicare.

Key Regulatory Signals

Mandatory Model With November 30 Effective Date: The GLOBE Model is structured as a mandatory Medicare payment model, not a voluntary demonstration. The rule takes effect November 30, 2026. Manufacturers of GLOBE Model drugs are mandatory participants, while providers and suppliers that furnish those drugs to model beneficiaries are not model participants; the model begins January 1, 2027.
Alternative Inflation Rebate Calculation: The model tests an alternative method for calculating Medicare Part B drug inflation rebate amounts. The source states that the model is designed to function alongside and in addition to the Medicare Part B Drug Inflation Rebate Program.
Scope Limited to Original Medicare: The GLOBE Model applies to Original Medicare, defined in the rule as Medicare fee-for-service and the traditional Medicare program. Medicare Advantage plans are not described as within the model's scope.
Cost and Quality Dual Test: CMS frames the model as testing whether the alternative pricing method reduces costs for Original Medicare beneficiaries and the Medicare program while preserving quality of care. The rule does not state a predetermined outcome or a fixed savings target figure.

Regulatory Delta

CMS tested drug pricing models under section 1115A authority as early as 2018, when it proposed the International Pricing Index model; that proposal was later withdrawn without advancing to a final rule.
The GLOBE Model introduces an alternative inflation rebate calculation methodology for Part B drugs. This is a structural departure from the rebate framework that has governed separately payable Part B drugs under existing Medicare payment rules.
The Inflation Reduction Act of 2022 established Medicare drug price negotiation and Part B inflation rebate requirements. The GLOBE Model does not displace that statutory framework; instead, it tests an alternative calculation method alongside it, using section 1115A innovation model authority as the operative vehicle.

Materiality Classification

HIGH — Final rule with an effective date of November 30, 2026, implementing a mandatory Medicare Part B drug payment model for manufacturers of GLOBE Model drugs, applied to a model cohort of Original Medicare beneficiaries in randomly selected geographic areas.

Time Horizon

effective — 2026-11-30

Intelligence Outlook

Monitor CMS and the Federal Register for implementing guidance, model participation specifications, and any administrative or legal proceedings related to this rulemaking ahead of the November 30, 2026 effective date.