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 137 entries
Date Action Taken Organization Name Action Taken Basis for Action Effective Date
2021-03-25 STI Pharma, P1389 Civil Money Penalty ($4,781.69) Late Payment 2021-05-23
2021-03-25 Romark Laboratories, P1175 Civil Money Penalty ($294,906.60) Non-Payment 2021-05-23
2021-03-25 Rouses Point Pharmaceutical, P1172 Civil Money Penalty ($312.86) Non-Payment 2021-05-23
2021-01-22 Midatech Pharma, P1348 Civil Money Penalty ($31,907.09) Non-Payment 2021-03-22
2021-01-22 Midatech Pharma, P1348 Civil Money Penalty ($41, 216.80) Non-Payment 2021-03-22
2020-11-24 FSC Laboratories, Inc., P1201 Civil Money Penalty ($40.90) Non-Payment 2021-01-22
2020-11-24 Rouses Point Pharmaceuticals, P1172 Civil Money Penalty ($10.86) Non-Payment 2021-01-22
2020-11-23 Akrimax Pharmaceuticals, LLC, P1151 Civil Money Penalty ($1.10) Non-Payment 2021-01-22
2020-07-10 FSC Laboratories, Inc. Civil Money Penalty ($91.71) Non-payment 2020-09-08
2020-07-10 Rouses Point Pharmaceuticals, P1172 Civil Money Penalty ($169.63) Non-payment 2020-09-08
Page Last Modified:
03/31/2016 06:21 AM