§ 423.2340 Compliance monitoring and civil money penalties.

(a) General rule. CMS monitors compliance by a manufacturer with the terms of the Coverage Gap Discount Program Agreement. (b) Basis for imposing civil money penalties. CMS imposes a civil money penalty (CMP) on a manufacturer that fails to provide applicable beneficiaries applicable discounts for applicable drugs of the manufacturer in accordance with the Coverage Gap Discount Program Agreement. (c) Determination of the civil money penalty amounts. CMS imposes a CMP for each failure by a manufacturer to provide an applicable discount in accordance with the Coverage Gap Discount Program Agreement equal to the sum of the following: (1) The amount of applicable discount the manufacturer would have paid under the Coverage Gap Discount Program Agreement, which will then be used to pay the applicable discount that the manufacturer had failed to provide. (2) Twenty-five percent of such amount. (d) Procedures for imposing civil money penalties. If CMS makes a determination to impose a CMP described in paragraph (c) of this section, CMS sends a written notice of its decision to impose a CMP to include the following: (1) A description of the basis for the determination. (2) The basis for the penalty. (3) The amount of the penalty. (4) The date the penalty is due. (5) The manufacturer's right to a hearing (as specified in § 423.1006). (6) Information about where to file the request for hearing. (e) Collection of civil money penalties imposed by CMS. (1) When a manufacturer does not request a hearing, CMS initiates the collection of the CMP following the expiration of the timeframe for requesting an ALJ hearing as specified in § 423.1020. (2) If a manufacturer requests a hearing and the Administrator upholds CMS' decision to impose a CMP, CMS may initiate collection of the CMP once the Administrator's decision is final. (f) Other applicable provisions. The provisions of section 1128A of the Act (except subsections (a) and (b) of section of 1128A of the Act) apply to CMPs under this section to the same extent that they apply to a CMP or procedure under section 1128A(a) of the Act.