Federal Register #2026-20281

CMS Finalizes GLOBE Model for Medicare Part B Drug Rebates

CMS finalized the GLOBE Model, a mandatory Medicare Part B drug rebate and payment model—not a purchase solicitation. - Government buyer: U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), CMS Innovation Center. - Program: The Global Benchmark for Efficient Drug Pricing (GLOBE) Model uses international drug-price benchmarks to calculate inflation rebates for qualifying, high-spend, single-source drugs and sole-source biologics. - Scope: Includes qualifying drugs in categories such as antineoplastics, blood products, central nervous system agents, immunological agents, and ophthalmic agents. Certain orphan-only drugs, cellular and gene therapies, plasma-derived products, and other specified categories are excluded. - Requirements and effects: The model establishes drug eligibility and rebate calculations, collects manufacturer rebates, adjusts Medicare payments to providers and suppliers, may reduce beneficiary coinsurance, and includes monitoring and evaluation. - OEMs and vendors: No manufacturers, OEMs, or vendors are identified by name. Pharmaceutical manufacturers may have rebate obligations under the model. - Procurement: No products or services are being purchased; no product quantities or part numbers are listed. CMS estimates $440 million in Medicare Part B net savings over the payment period.

Description

This final rule implements the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a new mandatory Medicare payment model under section 1115A of the Social Security Act. It tests an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable Part B drugs and biological products. The stated purpose is to determine whether the approach reduces costs for Original Medicare beneficiaries and the Medicare program while preserving quality of care. The regulations are effective November 30, 2026.

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