Part 428 — Medicare Part D Drug Inflation Rebate Program
Subpart A — General Provisions
Subpart B — Determination of Part D Rebatable Drugs
Subpart C — Determination of the Rebate Amount for Part D Rebatable Drugs
- § 428.200— Definitions.
- § 428.201— Calculation of the total rebate amount to be paid by manufacturers.
- § 428.202— Calculation of the per unit Part D rebate amount.
- § 428.203— Determination of the total number of units dispensed under Part D.
- § 428.204— Treatment of new formulations of Part D rebatable drugs.
Subpart D — Reducing the Rebate Amount for Part D Rebatable Drugs in Shortage and When There Is a Severe Supply Chain Disruption or Likely Shortage
- § 428.300— Definitions.
- § 428.301— Reducing the rebate amount for Part D rebatable drugs currently in shortage.
- § 428.302— Reducing the rebate amount for certain Part D rebatable drugs when there is a severe supply chain disruption.
- § 428.303— Reducing the rebate amount for generic Part D rebatable drugs likely to be in shortage.
Subpart E — Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments
- § 428.400— Definitions.
- § 428.401— Rebate Reports and reconciliation.
- § 428.402— Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023.
- § 428.403— Suggestion of Error.
- § 428.404— Manufacturer access to Rebate Reports.
- § 428.405— Deadline and process for payment of rebate amount.