Pharmaceutical Manufacturer Enforcement Actions

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:

Showing 1 – 10 of 205 entries

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Date Action Taken	Organization Name	Action Taken	Basis for Action	Effective Date
Date Action Taken 2024-12-20	Organization Name G1 Therapeutics Inc., P1759	Action Taken Civil Money Penalty ($996.05)	Basis for Action Late Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Scilex Pharmaceuticals, Inc., P1444	Action Taken Civil Money Penalty ($73,064.74)	Basis for Action Late Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Protega Pharmaceuticals LLC, P1826	Action Taken Civil Money Penalty ($11,341.16)	Basis for Action Late Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Bavarian Nordic, Inc., P1750	Action Taken Civil Money Penalty ($1,358.61)	Basis for Action Late Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Neolpharma, Inc., P1523	Action Taken Civil Money Penalty ($1,360.51)	Basis for Action Non-Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Sunrise Pharmaceutical, Inc., P1462	Action Taken Civil Money Penalty ($74,069.78)	Basis for Action Partial Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($2,864.28)	Basis for Action Non-Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name VistaPharm, Inc., P1403	Action Taken Civil Money Penalty ($45.14)	Basis for Action Non-Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Wockhardt USA LLC, P1292	Action Taken Civil Money Penalty ($53,137.44)	Basis for Action Non-Payment	Effective Date 2025-02-18
Date Action Taken 2024-12-20	Organization Name Hill Dermaceuticals, Inc., P1247	Action Taken Civil Money Penalty ($70.00)	Basis for Action Non-Payment	Effective Date 2025-02-18

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