Related Practices
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Medicare reimbursement for pharmaceutical products is currently the focus of intense legal, economic, and political interest and scrutiny. We are able to assist pharmaceutical manufacturers to navigate this dynamic and highly charged environment because we understand both the business drivers and economics of the industry, including the intricacies of Medicare Part B, the Medicare Part D prescription drug benefit, and the Medicaid Drug Rebate program. We have helped manufacturers develop their Part D rebating strategies and obtain Part D coverage for products. We are knowledgeable about the Part B Competitive Acquisition Program (CAP) and the complex issues surrounding Average Sales Price (ASP) reporting. We have assisted in the development of compliance strategies that will withstand the intense scrutiny surrounding the Medicare program.
Manufacturers’ obligations under the Medicaid Drug Rebate Program may seem simple in theory, but their application to complex marketing and pricing structures often raises complex issues. In the current regulatory environment, the determination of best price and the calculation of average manufacturers price (AMP) can have enormous economic and other consequences for pharmaceutical manufacturers. Covington & Burling LLP’s health care lawyers have extensive experience with CMS regulation in this arena. We can assist a manufacturer in resolving issues that may arise with CMS. Just as importantly, because of our extensive knowledge of the pharmaceutical industry, we can assist in ensuring that Drug Rebate considerations are taken into account in developing product marketing and pricing strategies.
Representative Matters
- Using an integrated regulatory and legislative strategy, we successfully assisted Kos Pharmaceuticals to obtain Part D coverage for its previously excluded product.
- We assisted several pharmaceutical manufacturers in developing Part D contract templates and negotiating Part D contracts with prescription drug plan sponsors.
- We assisted a pharmaceutical manufacturer in developing and implementing a strategy to obtain accelerated Medicaid coverage of a newly approved joint venture product.
- We assisted several manufacturers in determining restatements of AMP.
- We assisted several pharmaceutical manufacturers in reinstating Medicaid coverage for products dropped from the program by CMS.
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: Commercial & Partnering, Government Enforcement & Investigations, USA
- Leading: Competition/Antitrust, EU
- Highly Recommended: Corporate, Product Liability, USA
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