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:
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| Date Action Taken | Organization Name | Action Taken | Basis for Action | Effective Date |
|---|---|---|---|---|
| 2013-02-14 | DUSA Pharmaceuticals, Inc. | Civil Money Penalty ($21.47) | Late Payment | 2013-04-15 |
| 2013-02-14 | QLT Ophthalmics, Inc. | Civil Money Penalty ($64.14) | Late Payment | 2013-04-15 |
| 2013-02-14 | West-Ward Pharmaceuticals | Civil Money Penalty ($101.83) | Late Payment | 2013-04-15 |
| 2013-02-14 | Lehigh Valley Technologies, Inc. | Civil Money Penalty ($375.76) | Late Payment | 2013-04-15 |
| 2013-04-18 | B. Braun Medical Inc. | Civil Money Penalty ($610.69) | Late Payment | 2013-06-17 |
| 2013-04-18 | BioMarin Pharmaceutical | Civil Money Penalty ($918.71) | Late Payment | 2013-06-17 |
| 2013-04-18 | InterMune, Inc. | Civil Money Penalty ($3,965.15) | Non Payment | 2013-06-17 |
| 2013-04-18 | Fougera Pharmaceuticals | Civil Money Penalty ($73,605.43) | Late Payment | 2013-06-17 |
| 2013-04-18 | Actavis Kadian, LLC | Civil Money Penalty ($116,702.56) | Late Payment | 2013-06-17 |
| 2013-04-18 | Ferring Pharmaceuticals Inc. | Civil Money Penalty ($2,906.58) | Late Payment | 2013-06-17 |
| 2013-04-18 | QLT Ophthalmics, Inc. | Civil Money Penalty ($2,906.58) | Late Payment | 2013-06-17 |
| 2013-04-18 | Legacy Pharmaceuticals Puerto Rico | Civil Money Penalty ($942.16) | Late Payment | 2013-06-17 |
| 2013-04-18 | Angelini Pharma Inc. (Labopharm Pharmaceuticals LLC) | Civil Money Penalty ($1,874.45) | Late Payment | 2013-06-17 |
| 2013-06-27 | B. Braun Medical Inc. | Civil Money Penalty ($1,344.97) | Late Payment | 2013-08-26 |
| 2013-06-27 | Biomarin Pharmaceuticals, Inc. | Civil Money Penalty ($1,723.72) | Late Payment | 2013-08-26 |
| 2013-06-27 | Intermune, Inc. | Civil Money Penalty ($5,641.28) | Non-Payment | 2013-08-26 |
| 2013-06-27 | West-Ward Pharmaceuticals | Civil Money Penalty ($298.31) | Late Payment | 2013-08-26 |
| 2013-09-12 | Pernix Therapeutics | Civil Money Penalty ($732.96) | Late Payment | 2013-11-11 |
| 2013-09-12 | Intermune, Inc. | Civil Money Penalty (16,215.33) | Late Payment | 2013-11-11 |
| 2013-09-12 | Columbia Laboratories, Inc. | Civil Money Penalty ($58.69) | Late Payment | 2013-11-11 |
| 2013-09-12 | Hill Dermacuetical, Inc. | Civil Money Penalty ($831.47) | Late Payment | 2013-11-11 |
| 2013-09-12 | Tyo Healthcare Group LP | Civil Money Penalty ($105.83) | Late Payment | 2013-11-11 |
| 2013-09-12 | VersaPharm Inc. | Civil Money Penalty ($3,288.65) | Late Payment | 2013-11-11 |
| 2013-09-12 | Breckenridge Pharmaceutical Inc. | Civil Money Penalty ($113.49) | Late Payment | 2013-11-11 |
| 2013-11-14 | Ascend Laboratories, LLC | Civil Money Penalty ($3,623.12) | Late Payment | 2014-01-13 |
| 2013-11-14 | Archimedes Pharma US, Inc, | Civil Money Penalty ($338.86) | Late Payment | 2014-01-13 |
| 2014-02-27 | Seton Pharmaceuticals, LLC | Civil Money Penalty ($120.24) | Non-payment | 2014-04-28 |
| 2014-08-22 | Tyco Healthcare Group LP (d/b/a Covidien) | Civil Money Penalty ($415.45) | Non-Payment | 2014-10-21 |
| 2014-08-22 | Prometheus Laboratories Inc | Civil Money Penalty ($115,562.29) | Late Payment | 2014-10-21 |
| 2014-08-22 | Akrimax Pharmaceuticals, LLC | Civil Money Penalty ($100,222.23) | Late Payment | 2014-10-21 |
| 2015-07-14 | Auxilium Pharmaceutical, Inc. | Civil Money Penalty ($105,918.29) | Late Payment | 2015-09-14 |
| 2015-07-14 | Solco Healthcare U.S. LLC | Civil Money Penalty ($402.61) | Late Payment | 2015-09-14 |
| 2015-07-14 | Akrimax Pharmaceuticals, LLC | Civil Money Penalty ($31,350.06) | Late Payment | 2015-09-14 |
| 2015-07-14 | DUSA Pharmaceuticals, Inc. | Civil Money Penalty ($245.05) | Late Payment | 2015-09-14 |
| 2015-07-14 | Tyco Healthcare Group LP | Civil Money Penalty ($31.94) | Non-Payment | 2015-09-14 |
| 2015-07-14 | Amneal Pharmaceutical, LLC | Civil Money Penalty ($1,798.51) | Non-Payment | 2015-09-14 |
| 2015-07-14 | Vansen Pharma | Civil Money Penalty ($191.83) | Non-Payment | 2015-09-14 |
| 2015-07-14 | Vansen Pharma | Civil Money Penalty ($3,643.95) | Non-Payment | 2015-09-14 |
| 2015-10-09 | Aqua Pharmaceuticals | Civil Money Penalty ($5,577.19) | Late Payment | 2015-12-07 |
| 2015-09-22 | Tyco Healthcare Group | Civil Money Penalty ($113.44) | Non-Payment | 2015-11-20 |
| 2015-12-04 | Acton Pharmaceuticals, Inc. | Civil Money Penalty ($82.51) | Late Payment | 2016-02-01 |
| 2015-11-03 | Amneal Pharmaceutical, LLC | Civil Money Penalty ($5,909.43) | Late Payment | 2016-01-01 |
| 2015-10-09 | Mission Pharmaceutical | Civil Money Penalty ($9,658.60) | Late Payment | 2015-12-07 |
| 2015-10-09 | Generics Bidco, I, LLC | Civil Money Penalty ($58,983.39) | Late Payment | 2015-12-07 |
| 2015-10-09 | Aqua Pharmaceuticals | Civil Money Penalty ($362.11) | Late Payment | 2015-12-07 |
| 2015-10-09 | Hill Dermaceutical, Inc. | Civil Money Penalty ($37.77) | Late Payment | 2015-12-07 |
| 2015-09-22 | Tyco Healthcare Group | Civil Money Penalty ($165.31) | Non-Payment | 2015-11-20 |
| 2015-11-03 | Amneal Pharmaceutical, LLC | Civil Money Penalty ($9,439.66) | Late Payment | 2016-01-01 |
| 2015-09-22 | Tyco Healthcare Group | Civil Money Penalty ($180.90) | Non-Payment | 2015-11-20 |
| 2016-06-09 | Alexion Pharmaceuticals, Inc. | Civil Money Penalty ($3,250.14) | Late Payment | 2016-08-07 |
| 2016-06-09 | United-Guardian, Inc. | Civil Money Penalty ($437.26) | Late Payment | 2016-08-07 |
| 2016-06-09 | FSC Laboratories | Civil Money Penalty ($19,483.12) | Late Payment | 2016-08-07 |
| 2016-06-09 | ThromboGenics, Inc. | Civil Money Penalty ($195.59) | Late Payment | 2016-08-07 |
| 2016-06-09 | Tyco Healthcare Group | Civil Money Penalty ($13.07) | Late Payment | 2016-08-07 |
| 2016-06-09 | Amneal Pharmaceutical, LLC | Civil Money Penalty ($10,788.20) | Late Payment | 2016-08-07 |
| 2016-06-09 | Hyperion Therapeutics, Inc. | Civil Money Penalty ($504.16) | Late Payment | 2016-08-07 |
| 2016-06-09 | Heritage Pharmaceuticals | Civil Money Penalty ($36,610.76) | Late Payment | 2016-08-07 |
| 2016-06-09 | Amneal Pharmaceuticals, LLC | Civil Money Penalty ($12,366.76) | Late Payment | 2016-08-07 |
| 2016-06-09 | ThromboGenics, Inc. | Civil Money Penalty ($302.81) | Late Payment | 2016-08-07 |
| 2016-06-09 | Galena Biopharma, Inc. | Civil Money Penalty ($3,347.75) | Late Payment | 2016-08-07 |
| 2017-04-27 | Xanodyne Pharmaceuticals, Inc. | Civil Money Penalty ($40.00) | Late Payment | 2017-06-25 |
| 2017-04-27 | Medac Pharma, Inc. | Civil Money Penalty ($9,712.52) | Late Payment | 2017-06-25 |
| 2017-04-27 | Mikart, Inc. | Civil Money Penalty ($2,017.89) | Late Payment | 2017-06-25 |
| 2017-04-27 | XenoPort | Civil Money Penalty ($116,502.53) | Late Payment | 2017-06-25 |
| 2017-06-01 | VistaPharm, Inc. | Civil Money Penalty ($4,664.80) | Late Payment | 2017-07-31 |
| 2017-06-01 | Galena BioPharma, Inc. | Civil Money Penalty ($3,529.40) | Late Payment | 2017-07-31 |
| 2017-06-01 | Vernalis Therapeutics Inc. | Civil Money Penalty ($94.05) | Non-Payment | 2017-07-31 |
| 2017-05-17 | VistaPharm, Inc. | Civil Money Penalty ($4,374.99) | Late Payment | 2017-07-31 |
| 2017-04-27 | EMD Serono Inc. | Civil Money Penalty ($489.25) | Late Payment | 2017-06-25 |
| 2017-05-17 | Virtus Pharmaceuticals LLC | Civil Money Penalty ($704.54) | Late Payment | 2017-07-15 |
| 2017-06-01 | New Haven Pharmaceuticals | Civil Money Penalty ($1,980.11) | Non-Payment | 2017-07-31 |
| 2017-06-01 | New Haven Pharmaceuticals, Inc. | Civil Money Penalty ($1,934.89) | Non-Payment | 2017-07-31 |
| 2017-06-01 | New Haven Pharmaceuticals, Inc. | Civil Money Penalty ($2,187.08) | Non-Payment | 2017-07-31 |
| 2017-04-27 | VistaPharm, Inc. | Civil Money Penalty ($2,687.38) | Late Payment | 2017-06-25 |
| 2017-04-27 | Angelini Pharma Inc. | Civil Money Penalty ($1,185.73) | Late Payment | 2017-06-25 |
| 2017-04-27 | Angelini Pharma Inc. | Civil Money Penalty ($1,292.07) | Late Payment | 2017-06-25 |
| 2017-04-27 | Angelini Pharma Inc. | Civil Money Penalty ($708.28) | Late Payment | 2017-06-25 |
| 2017-04-27 | Angelini Pharma Inc. | Civil Money Penalty ($34.35) | Late Payment | 2017-06-25 |
| 2018-02-15 | Medimetriks Pharmaceuticals, P1037 | Civil Money Penalty ($790.76) | Late Payment | 2018-04-16 |
| 2017-09-08 | International Labs, Inc., P1193 | Civil Money Penalty ($13.64) | Late Payment | 2017-11-06 |
| 2017-04-27 | Generics Bidco, I, LLC. Dba Qualitest Pharmaceuticals | Civil Money Penalty ($322,998.00) | Late Payment | 2017-06-25 |
| 2018-01-18 | Medimetriks Pharmaceuticals, P1037 | Civil Money Penalty ($436.85) | Non-Payment | 2018-03-19 |
| 2018-01-18 | DUSA Pharmaceuticals, Inc., P1199 | Civil Money Penalty ($356.67) | Late Payment | 2018-03-19 |
| 2018-01-18 | Hill Dermaceutical, Inc., P1247 | Civil Money Penalty ($938.31) | Late Payment | 2018-03-19 |
| 2018-01-18 | Casper Pharma LLC, P1465 | Civil Money Penalty ($2,139.20) | Late Payment | 2018-03-19 |
| 2017-09-08 | VistaPharm, Inc., P1403 | Civil Money Penalty ($4,676.51) | Non-Payment | 2017-11-06 |
| 2018-06-29 | Virtus Pharmaceuticals, OpCo II, LLC. | Civil Money Penalty ($48,041.14) | Late Payment | 2018-08-28 |
| 2018-08-22 | WraSer Pharmaceuticals, P1313 | Civil Money Penalty ($31.56) | Late Payment | 2018-10-21 |
| 2018-08-22 | Medimetriks Pharmaceuticals, P1037 | Civl Money Penalty ($152.01) | Late Payment | 2018-10-21 |
- Page last Modified: 03/31/2016 10:21 AM
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