0938-AV74 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0938 Centers for Medicare & Medicaid Services CMS 0900 Department of Health and Human Services HHS Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546)

The GUARD Model tests new rebate formula for Medicare Part D drugs, which includes outpatient prescription drugs typically dispensed at retail, mail order, home infusion, and long-term care pharmacies. The GUARD Model will factor in existing Medicare Part D manufacturer rebates and discounts, and CMS will leverage its authority to test a change in the calculation of inflation rebates in Medicare Part D that accounts for how much certain drugs cost in economically similar countries. The intent of the GUARD Model is to test an innovative payment model that modifies the inflation rebate for GUARD Model drugs using international drug pricing information to identify a benchmark that reflects prices paid in a set of economically comparable countries, which CMS expects will reduce program expenditures for Medicare Part D while preserving or enhancing beneficiaries’ quality of care.

]]> Economically Significant First Time Published in The Unified Agenda Long-Term Actions Yes No Other 42 CFR 512 42 U.S.C. 1315a Statutory Final 12/23/2028 MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule. Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner. No NPRM 12/23/2025 90 FR 60338 NPRM Comment Period End 02/23/2026 Final Action 12/00/2028 Undetermined Federal Yes No No Amy Turner Deputy Director 0938 Centers for Medicare & Medicaid Services CMS 410 786-6781 amy.turner@cms.hhs.gov Center for Medicare and Medicaid Innovation, 7500 Security Boulevard, Baltimore MD 21244