CMS Pharmaceutical Manufacturer Enforcement Actions
Guidance for enforcement actions against pharmaceutical manufacturers participating in the coverage gap discount program.
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Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: March 31, 2016
Enforcement Actions against Pharmaceutical Manufacturers Participating in the Coverage Gap Discount Program
Under the Medicare Coverage Gap Discount Program (Discount Program), CMS imposes civil monetary penalties (CMPs) on participating manufacturers that fail to pay applicable discounts as required. Section 1860D-14A(e)(2) of the Affordable Care Act and section IV of the Discount Program Agreement require CMS to impose a civil monetary penalty (CMP) on a participating manufacturer that fails to provide applicable discounts in accordance with the Discount Program Agreement. The CMP is equal to the sum of the applicable discount payments that the manufacturer fails to provide plus 25% of such amount.
CMS has assessed the following CMPs:
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