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