Related Practices
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Virtually every participant in the health care industry is affected by the Medicare and Medicaid programs. Medicare is the nation’s largest payor for health care, and the rules governing both Medicare and Medicaid reimbursement are complex. Covington regularly advises and represents pharmaceutical manufacturers, device manufacturers, hospitals, and other health care providers, as they manage the risks and optimize the opportunities posed by these programs. Two recent and major pieces of federal legislation demonstrate the complexity of the Medicare and Medicaid programs and the intensity of the associated legislative, political, and policy interests:
- The Medicare Prescription Drug Improvement and Modernization Act of 2003 (the Medicare Modernization Act); and
- The Deficit Reduction Act of 2005 (the DRA).
Covington lawyers regularly advise clients with respect to reimbursement issues pertaining to all aspects of the Medicare program, including the Part D prescription drug benefit. We also advise pharmaceutical manufacturers with respect to their reporting and payment obligations under the Medicaid Drug Rebate program.
Representative Matters
- Using an integrated regulatory and legislative strategy, we successfully assisted Kos Pharmaceuticals to obtain Medicare Part D coverage for its previously excluded product.
- We assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by the Centers for Medicare & Medicaid Services (CMS).
- We were able to obtain helpful guidance from CMS attorneys on whether certain product changes reset the base average manufacturer price (AMP) for purposes of Medicaid rebates, the restatement of previously submitted best price and AMP reports, and the appropriate treatment for rebate calculation purposes of a complicated discount offering for a new product launch.
- We sought and received a written opinion from CMS concerning the Medicaid rebate treatment of a differential discount offer across different quarters.
- We developed for a major pharmaceutical client, proposals for new potential safe harbors under the federal anti-kickback statute for potential submission to the OIG.
Accolades
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2009)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Regulatory firm, Belgium, England, EU, and USA
- Leading: Regulatory (Medical Devices), USA
- Leading: Commercial & Partnering, Government Enforcement & Investigations, USA
- Leading: Competition/Antitrust, EU
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