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:

Date Action Taken	Organization Name	Action Taken	Basis for Action	Effective Date
Date Action Taken 2024-08-01	Organization Name Partner Therapeutics, P1631	Action Taken Civil Money Penalty ($19,993.36)	Basis for Action Late Payment	Effective Date 2024-09-30
Date Action Taken 2024-08-01	Organization Name Eyevance Pharmaceuticals, P1613	Action Taken Civil Money Penalty ($47,99.85)	Basis for Action Non-Payment	Effective Date 2024-09-30
Date Action Taken 2024-04-11	Organization Name Ascend Therapeutics, P1598	Action Taken Civil Money Penalty ($54,798.85)	Basis for Action Late Payment	Effective Date 2024-06-10
Date Action Taken 2024-04-11	Organization Name Neolpharma, P1523	Action Taken Civil Money Penalty ($5,409.73)	Basis for Action Non-Payment	Effective Date 2024-06-10
Date Action Taken 2024-04-11	Organization Name Camber Pharmaceuticals, P1159	Action Taken Civil Money Penalty ($479.97)	Basis for Action Late Payment	Effective Date 2024-06-10
Date Action Taken 2024-01-30	Organization Name P1571 Primal Critical Care-Pharmaceutical Manufacturers-CMP Determination Notice Letter	Action Taken Civil Money Penalty ($343.92)	Basis for Action Late Payment	Effective Date 2024-03-30
Date Action Taken 2024-01-30	Organization Name P1419 Everett Laboratories-Pharmaceutical Manufacturers-CMP Determination Notice Letter	Action Taken Civil Money Penalty ($5,826.40)	Basis for Action Non-payment	Effective Date 2024-03-30
Date Action Taken 2024-01-30	Organization Name Camber Pharmaceuticals, P1159	Action Taken Civil Money Penalty ($3,385.14)	Basis for Action Non-Payment	Effective Date 2024-03-30
Date Action Taken 2023-12-04	Organization Name Nabriva Therapeutics, P1559	Action Taken Civil Money Penalty ($137,295.59)	Basis for Action Non-Payment	Effective Date 2024-02-02
Date Action Taken 2023-12-01	Organization Name Vensun Pharmaceuticals, Inc., P1412	Action Taken Civil Money Penalty ($48,142.11)	Basis for Action Non-Payment	Effective Date 2024-01-30
Date Action Taken 2023-12-01	Organization Name HRA LLC, P1386	Action Taken Civil Money Penalty ($31,101.26)	Basis for Action Late Payment	Effective Date 2024-01-30
Date Action Taken 2023-12-01	Organization Name Vertex Pharmaceuticals, Inc., P1124	Action Taken Civil Money Penalty ($1,627.97)	Basis for Action Partial Late Payment	Effective Date 2024-01-30
Date Action Taken 2023-09-01	Organization Name Neolpharma, P1523	Action Taken Civil Money Penalty ($187.61)	Basis for Action Late Payment	Effective Date 2023-10-31
Date Action Taken 2023-09-01	Organization Name Nabriva Therapeutics, P1559	Action Taken Civil Money Penalty ($348,454.21)	Basis for Action Non-Payment	Effective Date 2023-10-31
Date Action Taken 2023-09-01	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($1,890.40)	Basis for Action Non-payment	Effective Date 2023-10-31
Date Action Taken 2023-09-01	Organization Name Vensun Pharmaceuticals, Inc., P1412	Action Taken Civil Money Penalty ($21,432.18)	Basis for Action Non-Payment	Effective Date 2023-10-31
Date Action Taken 2023-09-01	Organization Name kaleo, Inc., P1383	Action Taken Civil Money Penalty ($953.07)	Basis for Action Late Payment	Effective Date 2023-10-31
Date Action Taken 2023-04-27	Organization Name Athenex Pharmaceutical Division, LLC, P1645	Action Taken Civil Money Penalty ($204.20)	Basis for Action Late Payment	Effective Date 2023-06-27
Date Action Taken 2023-04-27	Organization Name Salerno Pharmaceuticals, LP, P1532	Action Taken Civil Money Penalty ($544.50)	Basis for Action Non-Payment	Effective Date 2023-06-26
Date Action Taken 2023-04-27	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($3,698.89)	Basis for Action Non-Payment	Effective Date 2023-06-26
Date Action Taken 2023-04-27	Organization Name Vensun Pharmaceuticals, Inc., P1412	Action Taken Civil Money Penalty ($53,694.63)	Basis for Action Non-Payment	Effective Date 2023-06-26
Date Action Taken 2023-04-27	Organization Name NextSource Biotechnology, LLC, P1393	Action Taken Civil Money Penalty ($34.28)	Basis for Action Late Payment	Effective Date 2023-06-26
Date Action Taken 2023-03-07	Organization Name Alnylam Pharmaceuticals, Inc., P1557	Action Taken Civil Money Penalty ($31,958.99)	Basis for Action Non-Payment	Effective Date 2023-05-06
Date Action Taken 2023-03-07	Organization Name Neolpharma, Inc., P1523	Action Taken Civil Money Penalty ($3,798.74)	Basis for Action Non-Payment	Effective Date 2023-05-06
Date Action Taken 2023-03-07	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($880.68)	Basis for Action Late Payment	Effective Date 2023-05-06
Date Action Taken 2023-03-07	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($463.19)	Basis for Action Non-Payment	Effective Date 2023-05-06
Date Action Taken 2023-01-06	Organization Name American Health Packaging, P1223	Action Taken Civil Money Penalty ($8,232.09)	Basis for Action Late Payment	Effective Date 2023-03-07
Date Action Taken 2023-01-06	Organization Name Neolpharma, Inc., P1523	Action Taken Civil Money Penalty ($352.84)	Basis for Action Late Payment	Effective Date 2023-03-07
Date Action Taken 2023-01-06	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($608.41)	Basis for Action Late Payment	Effective Date 2023-03-07
Date Action Taken 2023-01-06	Organization Name Scilex Pharmaceuticals, Inc., P1444	Action Taken Civil Money Penalty ($43,740.36)	Basis for Action Late Payment	Effective Date 2023-03-07
Date Action Taken 2023-01-06	Organization Name Alnylam Pharmaceuticals, Inc., P1557	Action Taken Civil Money Penalty ($4,528.35)	Basis for Action Late Payment	Effective Date 2023-03-07
Date Action Taken 2023-01-06	Organization Name Athenex Pharmaceutical Division, LLC, P1645	Action Taken Civil Money Penalty ($442.96)	Basis for Action Late Payment	Effective Date 2023-03-07
Date Action Taken 2022-08-22	Organization Name Athenex Pharmaceutical, P1645	Action Taken Civil Money Penalty ($1,874.75)	Basis for Action Non-Payment	Effective Date 2022-10-21
Date Action Taken 2022-08-04	Organization Name Sarfez Pharmaceuticals Inc, P1693	Action Taken Civil Money Penalty ($21.66)	Basis for Action Late Payment	Effective Date 2022-10-04
Date Action Taken 2022-08-04	Organization Name Eyevance Pharmaceuticals, P1613	Action Taken Civil Money Penalty ($8,402.69)	Basis for Action Late Payment	Effective Date 2022-10-04
Date Action Taken 2022-08-04	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($1,051.81)	Basis for Action Non-Payment	Effective Date 2022-10-04
Date Action Taken 2022-08-04	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($0.75)	Basis for Action Non-Payment	Effective Date 2022-10-04
Date Action Taken 2022-05-13	Organization Name Midatech Pharma, P1348	Action Taken Civil Money Penalty ($3,886.28)	Basis for Action Non-Payment	Effective Date 2022-07-12
Date Action Taken 2022-05-13	Organization Name Global Blood Therapeutics, P1616	Action Taken Civil Money Penalty ($2,756.61)	Basis for Action Late Payment	Effective Date 2022-07-12
Date Action Taken 2022-05-13	Organization Name Eyevance Pharmaceuticals, P1613	Action Taken Civil Money Penalty ($262,191.84)	Basis for Action Non-Payment	Effective Date 2022-07-12
Date Action Taken 2022-05-13	Organization Name NextSource Biotechnology, LLC, P1393	Action Taken Civil Money Penalty ($662.72)	Basis for Action Late Payment	Effective Date 2022-07-12
Date Action Taken 2022-05-13	Organization Name WraSer Pharmaceuticals, P1313	Action Taken Civil Money Penalty ($46.29)	Basis for Action Late Payment	Effective Date 2022-07-12
Date Action Taken 2022-05-13	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($182.25)	Basis for Action Non-Payment	Effective Date 2022-07-12
Date Action Taken 2022-05-13	Organization Name Lumara Health, P1056	Action Taken Civil Money Penalty ($2,166.03)	Basis for Action Late Payment	Effective Date 2022-07-12
Date Action Taken 2022-02-28	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($27,852.86)	Basis for Action Non-Payment	Effective Date 2022-04-29
Date Action Taken 2022-01-06	Organization Name Vertical Pharmaceutical, P1332	Action Taken Civil Money Penalty ($67,458.46)	Basis for Action Late Payment	Effective Date 2022-03-07
Date Action Taken 2021-12-10	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($308.21)	Basis for Action Non-Payment	Effective Date 2022-02-08
Date Action Taken 2021-12-10	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($76,780.14)	Basis for Action Non-Payment	Effective Date 2022-02-08
Date Action Taken 2021-07-29	Organization Name Encore Dermatology, P1489	Action Taken Civil Money Penalty ($2,431.24)	Basis for Action Late Payment	Effective Date 2021-09-27
Date Action Taken 2021-07-29	Organization Name R Pharma US, P1459	Action Taken Civil Money Penalty ($3,756.91)	Basis for Action Late Payment	Effective Date 2021-09-27
Date Action Taken 2021-07-29	Organization Name Everett Laboratories, P1419	Action Taken Civil Money Penalty ($341.90)	Basis for Action Non-Payment	Effective Date 2021-09-27
Date Action Taken 2021-07-29	Organization Name Midatech Pharma, P1348	Action Taken Civil Money Penalty ($8, 797.40)	Basis for Action Non-Payment	Effective Date 2021-09-27
Date Action Taken 2021-07-29	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($81,701.09)	Basis for Action Non-Payment	Effective Date 2021-09-27
Date Action Taken 2021-07-29	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penalty ($55.26)	Basis for Action Non-Payment	Effective Date 2021-09-27
Date Action Taken 2021-05-13	Organization Name Midatech Pharma US, Inc., P1348	Action Taken Civil Money Penalty ($25,669.78)	Basis for Action Non-payment	Effective Date 2021-07-12
Date Action Taken 2021-05-13	Organization Name Romark Laboratories, L.C., P1175	Action Taken Civil Money Penalty ($221,349.94)	Basis for Action Non-Payment	Effective Date 2021-07-12
Date Action Taken 2021-03-25	Organization Name STI Pharma, P1389	Action Taken Civil Money Penalty ($4,781.69)	Basis for Action Late Payment	Effective Date 2021-05-24
Date Action Taken 2021-03-25	Organization Name Romark Laboratories, P1175	Action Taken Civil Money Penalty ($294,906.60)	Basis for Action Non-Payment	Effective Date 2021-05-24
Date Action Taken 2021-03-25	Organization Name Rouses Point Pharmaceutical, P1172	Action Taken Civil Money Penalty ($312.86)	Basis for Action Non-Payment	Effective Date 2021-05-24
Date Action Taken 2021-01-22	Organization Name Midatech Pharma, P1348	Action Taken Civil Money Penalty ($31,907.09)	Basis for Action Non-Payment	Effective Date 2021-03-23
Date Action Taken 2021-01-22	Organization Name Midatech Pharma, P1348	Action Taken Civil Money Penalty ($41, 216.80)	Basis for Action Non-Payment	Effective Date 2021-03-23
Date Action Taken 2020-11-24	Organization Name FSC Laboratories, Inc., P1201	Action Taken Civil Money Penalty ($40.90)	Basis for Action Non-Payment	Effective Date 2021-01-23
Date Action Taken 2020-11-24	Organization Name Rouses Point Pharmaceuticals, P1172	Action Taken Civil Money Penalty ($10.86)	Basis for Action Non-Payment	Effective Date 2021-01-23
Date Action Taken 2020-11-24	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penalty ($1.10)	Basis for Action Non-Payment	Effective Date 2021-01-23
Date Action Taken 2020-07-10	Organization Name FSC Laboratories, Inc.	Action Taken Civil Money Penalty ($91.71)	Basis for Action Non-payment	Effective Date 2020-09-08
Date Action Taken 2020-07-10	Organization Name Rouses Point Pharmaceuticals, P1172	Action Taken Civil Money Penalty ($169.63)	Basis for Action Non-payment	Effective Date 2020-09-08
Date Action Taken 2020-07-10	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penalty ($1,053.59)	Basis for Action Non-payment	Effective Date 2020-09-08
Date Action Taken 2020-05-14	Organization Name Rouses Point Pharmaceuticals, P1172	Action Taken Civil Money Penalty ($1,121.64)	Basis for Action Non-payment	Effective Date 2020-07-13
Date Action Taken 2020-05-14	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penatly ($1,998.68)	Basis for Action Non-Payment	Effective Date 2020-07-13
Date Action Taken 2020-05-14	Organization Name Wockhardt USA, P1292	Action Taken Civil Money Penalty ($111,824.69)	Basis for Action Late Payment	Effective Date 2020-07-13
Date Action Taken 2020-05-14	Organization Name Symplmed Pharmaceuticals, P1500	Action Taken Civil Money Penalty ($143.53)	Basis for Action Non-Payment	Effective Date 2020-07-13
Date Action Taken 2020-05-14	Organization Name Solco Healthcare U.S. LLC, P1370	Action Taken Civil Money Penalty ($49.61)	Basis for Action Non-Payment	Effective Date 2020-07-13
Date Action Taken 2020-05-14	Organization Name FSC Laboratories Inc., P1201	Action Taken Civil Money Penalty ($3,596.51)	Basis for Action Non-Payment	Effective Date 2020-07-13
Date Action Taken 2020-05-10	Organization Name Cutanea Life Science, P1491	Action Taken Civil Money Penalty ($790.78)	Basis for Action Non-payment	Effective Date 2020-07-13
Date Action Taken 2020-02-27	Organization Name Rouses Point Pharmaceuticals, P1172	Action Taken Civil Money Penalty ($5,358.99)	Basis for Action Non-payment	Effective Date 2020-04-27
Date Action Taken 2020-02-27	Organization Name Symplmed Pharmaceuticals, P1500	Action Taken Civil Money Penalty ($394.36)	Basis for Action Non-payment	Effective Date 2020-04-27
Date Action Taken 2020-02-27	Organization Name FSC Laboratories, Inc., P1201	Action Taken Civil Money Penalty ($44,707.84)	Basis for Action Non-payment	Effective Date 2020-04-27
Date Action Taken 2020-02-27	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penalty ($5,879.13)	Basis for Action Non-Payment	Effective Date 2020-04-27
Date Action Taken 2019-12-05	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penalty ($10,005.66)	Basis for Action Non-payment	Effective Date 2020-02-03
Date Action Taken 2019-12-05	Organization Name Espero Pharmaceuticals, P1480	Action Taken Civil Money Penalty ($8,845.65)	Basis for Action Late Payment	Effective Date 2020-02-03
Date Action Taken 2019-12-05	Organization Name Rouses Point Pharmaceuticals, P1172	Action Taken Civil Money Penalty ($3,674.30)	Basis for Action Non-Payment	Effective Date 2020-02-03
Date Action Taken 2019-12-05	Organization Name FSC Laboratories, Inc., P1201	Action Taken Civil Money Penalty ($20,049.16)	Basis for Action Non-Payment	Effective Date 2020-02-03
Date Action Taken 2019-12-05	Organization Name Symplmed Pharmaceuticals, P1500	Action Taken Civil Money Penalty ($437.29)	Basis for Action Non-Payment	Effective Date 2020-02-03
Date Action Taken 2019-12-05	Organization Name Neolpharma, Inc., P1523	Action Taken Civil Money Penalty ($728.67)	Basis for Action Late Payment	Effective Date 2020-02-03
Date Action Taken 2019-07-26	Organization Name Espero Pharmaceuticals, P1480	Action Taken Civil Money Penalty ($21,330.54)	Basis for Action Non-Payment	Effective Date 2019-09-24
Date Action Taken 2019-07-26	Organization Name Akrimax Pharmaceuticals, LLC, P1151	Action Taken Civil Money Penalty ($46,749.50)	Basis for Action Non-Payment	Effective Date 2019-09-24
Date Action Taken 2019-07-26	Organization Name NextSource Biotechnology, LLC, P1393	Action Taken Civil Money Penalty ($46,258.23)	Basis for Action Non-Payment	Effective Date 2019-09-24
Date Action Taken 2019-07-26	Organization Name International Labs, Inc., P1193	Action Taken Civil Money Penalty ($4.43)	Basis for Action Late Payment	Effective Date 2019-09-24
Date Action Taken 2019-05-09	Organization Name NextSource Biotechnology, LLC	Action Taken Civil Money Penalty ($70,948.50)	Basis for Action Non-Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name Rouses Point Pharmaceuticals	Action Taken Civil Money Penalty ($5,421.16)	Basis for Action Late Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name Espero Pharmaceuticals	Action Taken Civil Money Penalty ($62,959.85)	Basis for Action Non-Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name Akrimax Pharmaceuticals, LLC	Action Taken Civil Money Penalty ($72,942.29)	Basis for Action Late Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name Everett Laboratories	Action Taken Civil Money Penalty ($135.13)	Basis for Action Late Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name Amneal Pharmaceuticals, LLC	Action Taken Civil Money Penalty ($12,968.30)	Basis for Action Late Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name Gemini Laboratories, LLC	Action Taken Civil Money Penalty ($10,045.32)	Basis for Action Late Payment	Effective Date 2019-07-08
Date Action Taken 2019-05-09	Organization Name International Labs, Inc.	Action Taken Civil Money Penalty ($6.35)	Basis for Action Non-Payment	Effective Date 2019-07-08
Date Action Taken 2019-03-08	Organization Name Exeltis USA, P1419	Action Taken Civil Money Penalty ($751.83)	Basis for Action Non-Payment	Effective Date 2019-05-07
Date Action Taken 2019-03-08	Organization Name Gemini Laboratories, LLC, P1433	Action Taken Civil Money Penalty ($6,107.90)	Basis for Action Late Payment	Effective Date 2019-05-07
Date Action Taken 2019-03-08	Organization Name Symplmed Pharmaceuticals, P1500	Action Taken Civil Money Penalty ($217.21)	Basis for Action Non-Payment	Effective Date 2019-05-07
Date Action Taken 2019-03-08	Organization Name DUSA Pharmaceuticals Inc., P1199	Action Taken Civil Money Penalty ($586.78)	Basis for Action Late Payment	Effective Date 2019-05-07
Date Action Taken 2019-03-08	Organization Name ApoPharma USA Inc., P1289	Action Taken Civil Money Penalty ($8,540.03)	Basis for Action Late Payment	Effective Date 2019-05-07
Date Action Taken 2018-12-14	Organization Name DUSA Pharmaceuticals, Inc., P1199	Action Taken Civil Money Penalty ($176.79)	Basis for Action Late Payment	Effective Date 2019-02-12
Date Action Taken 2018-08-22	Organization Name Medimetriks Pharmaceuticals, P1037	Action Taken Civl Money Penalty ($152.01)	Basis for Action Late Payment	Effective Date 2018-10-21
Date Action Taken 2018-08-22	Organization Name WraSer Pharmaceuticals, P1313	Action Taken Civil Money Penalty ($31.56)	Basis for Action Late Payment	Effective Date 2018-10-21
Date Action Taken 2018-06-29	Organization Name Virtus Pharmaceuticals, OpCo II, LLC.	Action Taken Civil Money Penalty ($48,041.14)	Basis for Action Late Payment	Effective Date 2018-08-28
Date Action Taken 2018-06-29	Organization Name IGI Labs, Inc., P1365	Action Taken Civil Money Penalty ($10,584.16)	Basis for Action Late Payment	Effective Date 2018-08-28
Date Action Taken 2018-02-15	Organization Name Medimetriks Pharmaceuticals, P1037	Action Taken Civil Money Penalty ($790.76)	Basis for Action Late Payment	Effective Date 2018-04-16
Date Action Taken 2018-01-18	Organization Name Casper Pharma LLC, P1465	Action Taken Civil Money Penalty ($2,139.20)	Basis for Action Late Payment	Effective Date 2018-03-19
Date Action Taken 2018-01-18	Organization Name DUSA Pharmaceuticals, Inc., P1199	Action Taken Civil Money Penalty ($356.67)	Basis for Action Late Payment	Effective Date 2018-03-19
Date Action Taken 2018-01-18	Organization Name Hill Dermaceutical, Inc., P1247	Action Taken Civil Money Penalty ($938.31)	Basis for Action Late Payment	Effective Date 2018-03-19
Date Action Taken 2018-01-18	Organization Name Medimetriks Pharmaceuticals, P1037	Action Taken Civil Money Penalty ($436.85)	Basis for Action Non-Payment	Effective Date 2018-03-19
Date Action Taken 2017-09-08	Organization Name International Labs, Inc., P1193	Action Taken Civil Money Penalty ($13.64)	Basis for Action Late Payment	Effective Date 2017-11-06
Date Action Taken 2017-09-08	Organization Name VistaPharm, Inc., P1403	Action Taken Civil Money Penalty ($4,676.51)	Basis for Action Non-Payment	Effective Date 2017-11-06
Date Action Taken 2017-06-01	Organization Name New Haven Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($2,187.08)	Basis for Action Non-Payment	Effective Date 2017-07-31
Date Action Taken 2017-06-01	Organization Name VistaPharm, Inc.	Action Taken Civil Money Penalty ($4,664.80)	Basis for Action Late Payment	Effective Date 2017-07-31
Date Action Taken 2017-06-01	Organization Name New Haven Pharmaceuticals	Action Taken Civil Money Penalty ($1,980.11)	Basis for Action Non-Payment	Effective Date 2017-07-31
Date Action Taken 2017-06-01	Organization Name New Haven Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($1,934.89)	Basis for Action Non-Payment	Effective Date 2017-07-31
Date Action Taken 2017-06-01	Organization Name Vernalis Therapeutics Inc.	Action Taken Civil Money Penalty ($94.05)	Basis for Action Non-Payment	Effective Date 2017-07-31
Date Action Taken 2017-06-01	Organization Name Galena BioPharma, Inc.	Action Taken Civil Money Penalty ($3,529.40)	Basis for Action Late Payment	Effective Date 2017-07-31
Date Action Taken 2017-05-17	Organization Name Virtus Pharmaceuticals LLC	Action Taken Civil Money Penalty ($704.54)	Basis for Action Late Payment	Effective Date 2017-07-15
Date Action Taken 2017-05-17	Organization Name VistaPharm, Inc.	Action Taken Civil Money Penalty ($4,374.99)	Basis for Action Late Payment	Effective Date 2017-07-31
Date Action Taken 2017-04-27	Organization Name Romark Laboratories	Action Taken Civil Money Penalty ($15,250.14)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Angelini Pharma Inc.	Action Taken Civil Money Penalty ($1,185.73)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name VistaPharm, Inc.	Action Taken Civil Money Penalty ($2,687.38)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Medac Pharma, Inc.	Action Taken Civil Money Penalty ($9,712.52)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Generics Bidco, I, LLC. Dba Qualitest Pharmaceuticals	Action Taken Civil Money Penalty ($322,998.00)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name EMD Serono Inc.	Action Taken Civil Money Penalty ($489.25)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Angelini Pharma Inc.	Action Taken Civil Money Penalty ($34.35)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Angelini Pharma Inc.	Action Taken Civil Money Penalty ($708.28)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Mikart, Inc.	Action Taken Civil Money Penalty ($2,017.89)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Xanodyne Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($40.00)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name Angelini Pharma Inc.	Action Taken Civil Money Penalty ($1,292.07)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2017-04-27	Organization Name XenoPort	Action Taken Civil Money Penalty ($116,502.53)	Basis for Action Late Payment	Effective Date 2017-06-25
Date Action Taken 2016-06-09	Organization Name ThromboGenics, Inc.	Action Taken Civil Money Penalty ($302.81)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Tyco Healthcare Group	Action Taken Civil Money Penalty ($13.07)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Galena Biopharma, Inc.	Action Taken Civil Money Penalty ($3,347.75)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Heritage Pharmaceuticals	Action Taken Civil Money Penalty ($36,610.76)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Amneal Pharmaceuticals, LLC	Action Taken Civil Money Penalty ($12,366.76)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Amneal Pharmaceutical, LLC	Action Taken Civil Money Penalty ($10,788.20)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Hyperion Therapeutics, Inc.	Action Taken Civil Money Penalty ($504.16)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name United-Guardian, Inc.	Action Taken Civil Money Penalty ($437.26)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name Alexion Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($3,250.14)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name ThromboGenics, Inc.	Action Taken Civil Money Penalty ($195.59)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2016-06-09	Organization Name FSC Laboratories	Action Taken Civil Money Penalty ($19,483.12)	Basis for Action Late Payment	Effective Date 2016-08-07
Date Action Taken 2015-12-04	Organization Name Acton Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($82.51)	Basis for Action Late Payment	Effective Date 2016-02-01
Date Action Taken 2015-11-03	Organization Name Amneal Pharmaceutical, LLC	Action Taken Civil Money Penalty ($9,439.66)	Basis for Action Late Payment	Effective Date 2016-01-01
Date Action Taken 2015-11-03	Organization Name Amneal Pharmaceutical, LLC	Action Taken Civil Money Penalty ($5,909.43)	Basis for Action Late Payment	Effective Date 2016-01-01
Date Action Taken 2015-10-09	Organization Name Hill Dermaceutical, Inc.	Action Taken Civil Money Penalty ($37.77)	Basis for Action Late Payment	Effective Date 2015-12-07
Date Action Taken 2015-10-09	Organization Name Aqua Pharmaceuticals	Action Taken Civil Money Penalty ($5,577.19)	Basis for Action Late Payment	Effective Date 2015-12-07
Date Action Taken 2015-10-09	Organization Name Generics Bidco, I, LLC	Action Taken Civil Money Penalty ($58,983.39)	Basis for Action Late Payment	Effective Date 2015-12-07
Date Action Taken 2015-10-09	Organization Name Mission Pharmaceutical	Action Taken Civil Money Penalty ($9,658.60)	Basis for Action Late Payment	Effective Date 2015-12-07
Date Action Taken 2015-10-09	Organization Name Aqua Pharmaceuticals	Action Taken Civil Money Penalty ($362.11)	Basis for Action Late Payment	Effective Date 2015-12-07
Date Action Taken 2015-09-22	Organization Name Tyco Healthcare Group	Action Taken Civil Money Penalty ($165.31)	Basis for Action Non-Payment	Effective Date 2015-11-20
Date Action Taken 2015-09-22	Organization Name Tyco Healthcare Group	Action Taken Civil Money Penalty ($113.44)	Basis for Action Non-Payment	Effective Date 2015-11-20
Date Action Taken 2015-09-22	Organization Name Tyco Healthcare Group	Action Taken Civil Money Penalty ($180.90)	Basis for Action Non-Payment	Effective Date 2015-11-20
Date Action Taken 2015-07-14	Organization Name DUSA Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($245.05)	Basis for Action Late Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Solco Healthcare U.S. LLC	Action Taken Civil Money Penalty ($402.61)	Basis for Action Late Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Tyco Healthcare Group LP	Action Taken Civil Money Penalty ($31.94)	Basis for Action Non-Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Vansen Pharma	Action Taken Civil Money Penalty ($191.83)	Basis for Action Non-Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Amneal Pharmaceutical, LLC	Action Taken Civil Money Penalty ($1,798.51)	Basis for Action Non-Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Vansen Pharma	Action Taken Civil Money Penalty ($3,643.95)	Basis for Action Non-Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Akrimax Pharmaceuticals, LLC	Action Taken Civil Money Penalty ($31,350.06)	Basis for Action Late Payment	Effective Date 2015-09-14
Date Action Taken 2015-07-14	Organization Name Auxilium Pharmaceutical, Inc.	Action Taken Civil Money Penalty ($105,918.29)	Basis for Action Late Payment	Effective Date 2015-09-14
Date Action Taken 2014-08-22	Organization Name Akrimax Pharmaceuticals, LLC	Action Taken Civil Money Penalty ($100,222.23)	Basis for Action Late Payment	Effective Date 2014-10-21
Date Action Taken 2014-08-22	Organization Name Prometheus Laboratories Inc	Action Taken Civil Money Penalty ($115,562.29)	Basis for Action Late Payment	Effective Date 2014-10-21
Date Action Taken 2014-08-22	Organization Name Tyco Healthcare Group LP (d/b/a Covidien)	Action Taken Civil Money Penalty ($415.45)	Basis for Action Non-Payment	Effective Date 2014-10-21
Date Action Taken 2014-02-27	Organization Name Seton Pharmaceuticals, LLC	Action Taken Civil Money Penalty ($120.24)	Basis for Action Non-payment	Effective Date 2014-04-28
Date Action Taken 2013-11-14	Organization Name Archimedes Pharma US, Inc,	Action Taken Civil Money Penalty ($338.86)	Basis for Action Late Payment	Effective Date 2014-01-13
Date Action Taken 2013-11-14	Organization Name Ascend Laboratories, LLC	Action Taken Civil Money Penalty ($3,623.12)	Basis for Action Late Payment	Effective Date 2014-01-13
Date Action Taken 2013-09-12	Organization Name VersaPharm Inc.	Action Taken Civil Money Penalty ($3,288.65)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-09-12	Organization Name Hill Dermacuetical, Inc.	Action Taken Civil Money Penalty ($831.47)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-09-12	Organization Name Columbia Laboratories, Inc.	Action Taken Civil Money Penalty ($58.69)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-09-12	Organization Name Intermune, Inc.	Action Taken Civil Money Penalty (16,215.33)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-09-12	Organization Name Pernix Therapeutics	Action Taken Civil Money Penalty ($732.96)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-09-12	Organization Name Tyo Healthcare Group LP	Action Taken Civil Money Penalty ($105.83)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-09-12	Organization Name Breckenridge Pharmaceutical Inc.	Action Taken Civil Money Penalty ($113.49)	Basis for Action Late Payment	Effective Date 2013-11-11
Date Action Taken 2013-06-27	Organization Name Intermune, Inc.	Action Taken Civil Money Penalty ($5,641.28)	Basis for Action Non-Payment	Effective Date 2013-08-26
Date Action Taken 2013-06-27	Organization Name West-Ward Pharmaceuticals	Action Taken Civil Money Penalty ($298.31)	Basis for Action Late Payment	Effective Date 2013-08-26
Date Action Taken 2013-06-27	Organization Name Biomarin Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($1,723.72)	Basis for Action Late Payment	Effective Date 2013-08-26
Date Action Taken 2013-06-27	Organization Name B. Braun Medical Inc.	Action Taken Civil Money Penalty ($1,344.97)	Basis for Action Late Payment	Effective Date 2013-08-26
Date Action Taken 2013-04-18	Organization Name Ferring Pharmaceuticals Inc.	Action Taken Civil Money Penalty ($2,906.58)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name BioMarin Pharmaceutical	Action Taken Civil Money Penalty ($918.71)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name Angelini Pharma Inc. (Labopharm Pharmaceuticals LLC)	Action Taken Civil Money Penalty ($1,874.45)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name QLT Ophthalmics, Inc.	Action Taken Civil Money Penalty ($2,906.58)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name B. Braun Medical Inc.	Action Taken Civil Money Penalty ($610.69)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name Legacy Pharmaceuticals Puerto Rico	Action Taken Civil Money Penalty ($942.16)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name InterMune, Inc.	Action Taken Civil Money Penalty ($3,965.15)	Basis for Action Non Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name Actavis Kadian, LLC	Action Taken Civil Money Penalty ($116,702.56)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-04-18	Organization Name Fougera Pharmaceuticals	Action Taken Civil Money Penalty ($73,605.43)	Basis for Action Late Payment	Effective Date 2013-06-17
Date Action Taken 2013-02-14	Organization Name Lehigh Valley Technologies, Inc.	Action Taken Civil Money Penalty ($375.76)	Basis for Action Late Payment	Effective Date 2013-04-15
Date Action Taken 2013-02-14	Organization Name QLT Ophthalmics, Inc.	Action Taken Civil Money Penalty ($64.14)	Basis for Action Late Payment	Effective Date 2013-04-15
Date Action Taken 2013-02-14	Organization Name West-Ward Pharmaceuticals	Action Taken Civil Money Penalty ($101.83)	Basis for Action Late Payment	Effective Date 2013-04-15
Date Action Taken 2013-02-14	Organization Name DUSA Pharmaceuticals, Inc.	Action Taken Civil Money Penalty ($21.47)	Basis for Action Late Payment	Effective Date 2013-04-15
Date Action Taken	Organization Name DUSA Pharmaceuticals, Inc., P1523	Action Taken Civil Money Penalty ($823.52)	Basis for Action Late Payment	Effective Date 2023-10-31

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Enforcement Actions against Pharmaceutical Manufacturers Participating in the Coverage Gap Discount Program