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 | 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 |
| 2022-05-12 | WraSer Pharmaceuticals, P1313 | Civil Money Penalty ($46.29) | Late 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 | Romark Laboratories, P1175 | Civil Money Penalty ($76,780.14) | Non-Payment | 2022-02-07 |
Page Last Modified:
12/01/2021 07:02 PM