42 CFR Part 428
PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM
- PART 428—MEDICARE PART D DRUG INFLATION REBATE PROGRAM
- Chapter IV—Centers for Medicare & Medicaid Services, Department of Health and Human Services › Subchapter B—Medicare Program
- Subpart A—General Provisions
- § 428.10 Basis and scope.
- § 428.20 Definitions.
- Subpart B—Determination of Part D Rebatable Drugs
- § 428.100 Definitions.
- § 428.101 Identification 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.
- Subpart F—Enforcement of Manufacturer Payment of Rebate Amounts
- § 428.500 Civil money penalty notice and appeals procedures.
Feedback