U.S. FEDRegulation
CMS finalizes mandatory Medicare drug-pricing GLOBE model
CMS issued a final rule (CMS-5545-F, 91 FR 62936) on October 2, 2026, creating the mandatory Global Benchmark for Efficient Drug Pricing (GLOBE) Model at 42 CFR Part 513, effective November 30, 2026. Manufacturers of included single-source Medicare Part B rebatable drugs with over $100 million in annual spending must participate, with rebates applying when U.S. prices exceed benchmarks from 19 reference countries. Performance years run April 2027 through March 2032.
Key points
- Final rule CMS-5545-F (RIN 0938-AV66, 91 FR 62936) adds 42 CFR Part 513, effective November 30, 2026.Federal Register
- Manufacturers of included GLOBE Model drugs must participate; about 25% of Original Medicare beneficiaries in selected ZIP Code areas are covered.Federal Register
- Included drugs are single-source Part B rebatable drugs in specified classes, such as antineoplastics, with over $100 million in annual spending.Federal Register
- Excluded are orphan-only drugs, cell and gene therapies, plasma-derived products and drugs under the Medicare Drug Price Negotiation Program.Federal Register
- Data collection begins January 1, 2027; performance years run April 2027 to March 2032, with payment reconciliation through March 2034.Federal Register
- Benchmarks use pricing from 19 reference countries; manufacturer submission of international net-price data is voluntary.Federal Register
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Federal Register