Compliance and Fraud and Abuse Counseling
Our global practice assists life sciences and healthcare clients in complying with requirements pertaining to investigational and marketed products and the delivery of clinical services. We advise on the full range of issues arising under the federal Anti-Kickback Statute; the Stark Law; the False Claims Act; the Federal Food, Drug, and Cosmetic Act; and other federal and state fraud and abuse laws. We also assist in formulating compliance strategies, performing self-evaluative audits, conducting internal investigations, designing compliance and corrective action plans, and mitigating liability—where appropriate—through self-reporting. An integral part of our work involves developing offensive and defensive strategies relating to the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs, the Department of Health and Human Services Office of the Inspector General, and the VA Offices of the Inspector General.
Proactive Counsel: We help clients structure commercial agreements and complex ventures to avoid violation of the myriad of fraud and abuse constraints, and we routinely develop written policies for clients in connection with sales, marketing and pricing strategies.
Depth of Experience: Several of our partners have held high-ranking positions at HHS, DOJ and CMS, and we have a deep understanding of the government's expectations, emerging theories and enforcement trends.
Global Scope: We routinely conduct proactive compliance reviews and investigate alleged compliance lapses in jurisdictions around the world, and we have assisted clients in building harmonized global compliance programs.