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 109 entries
| Date Action Taken | Organization Name | Action Taken | Basis for Action | Effective Date |
|---|---|---|---|---|
| 2019-07-26 | Akrimax Pharmaceuticals, LLC, P1151 | Civil Money Penalty ($46,749.50) | Non-Payment | 2019-09-24T12:00:00 |
| 2019-07-26 | International Labs, Inc., P1193 | Civil Money Penalty ($4.43) | Late Payment | 2019-09-24T12:00:00 |
| 2019-07-26 | Espero Pharmaceuticals, P1480 | Civil Money Penalty ($21,330.54) | Non-Payment | 2019-09-24T12:00:00 |
| 2019-07-26 | NextSource Biotechnology, LLC, P1393 | Civil Money Penalty ($46,258.23) | Non-Payment | 2019-09-24T12:00:00 |
| 2019-05-09 | Akrimax Pharmaceuticals, LLC | Civil Money Penalty ($72,942.29) | Late Payment | 2019-07-08T12:00:00 |
| 2019-05-09 | International Labs, Inc. | Civil Money Penalty ($6.35) | Non-Payment | 2019-07-08T12:00:00 |
| 2019-05-09 | Everett Laboratories | Civil Money Penalty ($135.13) | Late Payment | 2019-07-08T12:00:00 |
| 2019-05-09 | Rouses Point Pharmaceuticals | Civil Money Penalty ($5,421.16) | Late Payment | 2019-07-08T12:00:00 |
| 2019-05-09 | Espero Pharmaceuticals | Civil Money Penalty ($62,959.85) | Non-Payment | 2019-07-08T12:00:00 |
| 2019-05-09 | Gemini Laboratories, LLC | Civil Money Penalty ($10,045.32) | Late Payment | 2019-07-08T12:00:00 |
Page Last Modified:
03/31/2016 10:21 AM