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