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 156 entries
Date Action Taken Organization Name Action Taken Basis for Action Effective Date
2022-05-12 WraSer Pharmaceuticals, P1313 Civil Money Penalty ($46.29) Late Payment 2022-07-11
2022-05-12 Lumara Health, P1056 Civil Money Penalty ($2,166.03) Late Payment 2022-07-11
2022-05-12 Global Blood Therapeutics, P1616 Civil Money Penalty ($2,756.61) Late Payment 2022-07-11
2022-05-12 NextSource Biotechnology, LLC, P1393 Civil Money Penalty ($662.72) Late Payment 2022-07-11
2022-05-12 Romark Laboratories, P1175 Civil Money Penalty ($182.25) Non-Payment 2022-07-11
2022-05-12 Midatech Pharma, P1348 Civil Money Penalty ($3,886.28) Non-Payment 2022-07-11
2022-05-12 Eyevance Pharmaceuticals, P1613 Civil Money Penalty ($262,191.84) Non-Payment 2022-07-11
2022-02-27 Romark Laboratories, P1175 Civil Money Penalty ($27,852.86) Non-Payment 2022-04-28
2022-01-05 Vertical Pharmaceutical, P1332 Civil Money Penalty ($67,458.46) Late Payment 2022-03-06
2021-12-09 Everett Laboratories, P1419 Civil Money Penalty ($308.21) Non-Payment 2022-02-07
Page Last Modified:
12/01/2021 07:02 PM