1. (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. (1) Condition for coverage of applicable drugs under Part D.
   2. (2) The Medicare Coverage Gap Discount Program Agreement.
   3. (3) Coverage gap discount payment processes for Part D sponsors.
   4. (4) Provision of applicable discounts on applicable drugs for applicable beneficiaries.
   5. (5) Manufacturer audit and dispute resolution processes.
   6. (6) Resolution of beneficiary disputes involving coverage gap discounts.
   7. (7) Compliance monitoring and civil money penalties.
   8. (8) The termination of the Medicare Coverage Gap Discount Program Agreement.
2. (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.

[77 FR 22172, Apr. 12, 2012, as amended at 91 FR 17592, Apr. 6, 2026]