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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
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