Covington advises and represents pharmaceutical manufacturers, device manufacturers, hospitals, health plans, and other health care providers on issues involving reimbursement in the Medicare and Medicaid programs and issues of health information privacy. Our broad practice and deep-rooted understanding of the structure and operations of federal and state reimbursement programs enable us to develop workable solutions to complex problems and to assist our clients in developing strategies that provide a competitive advantage, minimize risk, and optimize opportunities.
Whether we are providing advice, working legislatively, or negotiating with the Centers for Medicare & Medicaid Services (“CMS”), we have the knowledge, skills, and expertise to assist pharmaceutical manufacturers, device manufacturers, and providers in navigating the intricacies of Medicare and Medicaid reimbursement. We 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. We have advised hospitals and health plans on intricate federal rules and policy governing such areas as upper payment limits and reimbursement for graduate medical education. In disputes between providers and their Medicare fiscal intermediaries, we have appeared before the HHS Provider Reimbursement Review Board and in court.
Our lawyers bring to the table:
- Government experience;
- Detailed knowledge of relevant laws and regulations;
- Ability to work with regulators and legislators; and
- Understanding of clients’ business models.
- 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 assisted numerous pharmaceutical manufacturers to ensure that their research activities conform to HIPAA and European data privacy requirements (activities included preparing investigator disclosure documents, contract research organization (CRO) agreements, clinical trial agreements, service provider agreements, informed consents and authorizations).
- Law360’s "Practice Group of the Year," Health (2011)
- 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
- Highly Recommended: Corporate, Product Liability, USA