42 CFR Part 427
PART 427—MEDICARE PART B DRUG INFLATION REBATE PROGRAM
- PART 427—MEDICARE PART B 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
- § 427.10 Basis and scope.
- § 427.20 Definitions.
- Subpart B—Determination of Part B Rebatable Drugs
- § 427.100 Definitions.
- § 427.101 Identification of Part B rebatable drugs.
- Subpart C—Coinsurance Adjustment and Adjusted Medicare Payment for Part B Rebatable Drugs With Price Increases Faster Than Inflation
- § 427.200 Definitions.
- § 427.201 Computation of beneficiary coinsurance and adjusted Medicare payment for Part B rebatable drugs with price increases faster than inflation.
- Subpart D—Determination of the Rebate Amount for Part B Rebatable Drugs
- § 427.300 Definitions.
- § 427.301 Calculation of the total Part B rebate amount to be paid by manufacturers.
- § 427.302 Calculation of the per unit Part B rebate.
- § 427.303 Determination of total number of billing units.
- § 427.304 Adjustments for changes to billing and payment codes.
- Subpart E—Reducing the Rebate Amount for Part B Rebatable Drugs in Shortage and When There Is a Severe Supply Chain Disruption
- § 427.400 Definitions.
- § 427.401 Reducing the rebate amount for Part B rebatable drugs currently in shortage.
- § 427.402 Reducing the rebate amount for certain Part B rebatable drugs when there is a severe supply chain disruption.
- Subpart F—Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments
- § 427.500 Definitions.
- § 427.501 Rebate Reports and reconciliation.
- § 427.502 Rebate Reports for applicable calendar quarters in calendar years 2023 and 2024.
- § 427.503 Suggestion of Error.
- § 427.504 Manufacturer access to Rebate Reports.
- § 427.505 Deadline and process for payment of rebate amount.
- Subpart G—Enforcement of Manufacturer Payment of Rebate Amounts
- § 427.600 Civil money penalty notice and appeals procedures.