GroundRules
42 CFR 423.2300: Scope.
Where this section sits in the code
- Title 42—Public Health
- CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER B—MEDICARE PROGRAM
- PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
- Subpart W—Medicare Coverage Gap Discount Program
(a) Scope. This subpart sets forth the requirements for the Medicare coverage gap discount program based on provisions included in sections 1860D-14A and 1860D-43 of the Act, as follows:
(1) Condition for coverage of applicable drugs under Part D.
(2) The Medicare Coverage Gap Discount Program Agreement.
(3) Coverage gap discount payment processes for Part D sponsors.
(4) Provision of applicable discounts on applicable drugs for applicable beneficiaries.
(5) Manufacturer audit and dispute resolution processes.
(6) Resolution of beneficiary disputes involving coverage gap discounts.
(7) Compliance monitoring and civil money penalties.
(8) The termination of the Medicare Coverage Gap Discount Program Agreement.
(b) Applicability. The requirements of this subpart apply before January 1, 2025, and, with respect to applicable drugs dispensed prior to such date, continue to apply on and after January 1, 2025.
Collected 2026-08-27T02:26:11Z. Source file · JSON