Global Benchmark for Efficient Drug Pricing (GLOBE) Model

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Part 513 [CMS-5545-F] RIN 0938-AV66 ( printed page 62936) AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Final rule. SUMMARY: This final rule implements the Global Benchmark for Efficient Drug Pricing Model (GLOBE Model), a new mandatory Medicare payment model under section 1115A of the Social Security Act. The GLOBE Model will test whether a payment model that uses an alternative method for calculating Medicare Part B drug inflation rebate amounts for certain separately payable Medicare Part B drugs and biological products reduces costs for Original Medicare (OM) beneficiaries and the Medicare program while preserving quality of care. The term OM has the same meaning as Medicare fee-for-service and the traditional Medicare program. DATES: These regulations are effective on November 30, 2026. FOR FURTHER INFORMATION CONTACT: Nicholas Minter, (410) 786-8914 or GLOBEmodel@cms.hhs.gov . SUPPLEMENTARY INFORMATION: I. Executive Summary and Background A. Background Overview The high cost of healthcare continues to impact many Americans' lives. According to the West Health-Gallup Affordability Index, only 61 percent of adults over age 65 in the United States (U.S.) are considered “Cost Secure,” where a person has “access to quality, affordable care and ha[s] been able to pay for visits and prescriptions in r…