42 CFR 423.2300 - Scope.
This subpart implements provisions included in sections 1860D-14A and 1860D-43 of the Act. This subpart sets forth requirements regarding the following:
(a) Condition for coverage of applicable drugs under Part D.
(e) Manufacturer audit and dispute resolution processes.
(g) Compliance monitoring and civil money penalties.
(h) The termination of the Discount Program Agreement.