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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.

Overall Description of Deadline: 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.