Health Law

Fraud & Abuse, Compliance & Regulatory Counseling

The health care and life sciences industries are certainly accustomed to regulatory oversight. Federal and state laws and regulations impact a substantial number of your day-to-day business activities. At the forefront of government scrutiny are health care fraud and abuse laws, including the federal Anti-kickback Statute, the Stark Law, the False Claims Act, and analogous state laws and regulations. Weighing legal risks and business considerations is a challenge that your company faces on a daily basis.

Our Health Law attorneys stay in stride with our busy clients, providing counseling on sales and marketing and other regulatory and compliance issues. To help prevent problems down the road, our attorneys can design and help implement your compliance program and can provide general and specialized compliance training. We also audit the effectiveness of health care compliance programs and conduct internal investigations when the need arises.

Our health law regulatory and compliance knowledge underlies our ability to counsel clients on transactional matters. We regularly advise clients on the structure of proposed business arrangements and financial relationships, such as mergers and acquisitions, joint ventures, affiliations, service agreements, employment and independent contractor relationships, leases, and physician recruitment arrangements.

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Representative Experience

  • Defend clients against alleged violations of laws prohibiting the following:
    • Offering or receipt of kickbacks and other financial inducements
    • Filing of false claims with government health insurance programs
    • Marketing of drugs and devices in violation of the Food, Drug, and Cosmetic Act
    • Maintenance of financial relationships that create unlawful conflicts of interest
  • Draft compliance program documents for medical device manufacturers, clinical laboratories, group purchasing organizations, and other clients, and advise on compliance program implementation.
  • Provide specialized compliance training for sales force employees of pharmaceutical manufacturers, medical device companies, and clinical laboratories.
  • Advise multiple pharmaceutical manufacturers and medical device companies on the application of state and federal laws requiring implementation of certain compliance policies and reporting of transfers of value to physicians and other health care professionals.
  • Conduct a state-by-state analysis and audit of a managed care organization’s operations for fraud, abuse, and waste.
  • Counsel pharmacy benefit managers on numerous regulatory issues, including Medicare Part D compliance and HIPAA privacy and security compliance.