Title 42, Part 428 — Medicare Part D Drug Inflation Rebate Program
20 sections
Section 428.10
Basis and scope.
Section 428.20
Definitions.
Section 428.100
Definitions.
Section 428.101
Identification of Part D rebatable drugs.
Section 428.200
Definitions.
Section 428.201
Calculation of the total rebate amount to be paid by manufacturers.
Section 428.202
Calculation of the per unit Part D rebate amount.
Section 428.203
Determination of the total number of units dispensed under Part D.
Section 428.204
Treatment of new formulations of Part D rebatable drugs.
Section 428.300
Definitions.
Section 428.301
Reducing the rebate amount for Part D rebatable drugs currently in shortage.
Section 428.302
Reducing the rebate amount for certain Part D rebatable drugs when there is a severe supply chain disruption.
Section 428.303
Reducing the rebate amount for generic Part D rebatable drugs likely to be in shortage.
Section 428.400
Definitions.
Section 428.401
Rebate Reports and reconciliation.
Section 428.402
Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023.
Section 428.403
Suggestion of Error.
Section 428.404
Manufacturer access to Rebate Reports.
Section 428.405
Deadline and process for payment of rebate amount.
Section 428.500
Civil money penalty notice and appeals procedures.