Health Law

Health Care Enforcement Defense

In recent years, federal and state agencies have become both more active and more aggressive in investigating and prosecuting alleged health care fraud. No entity in the health industry is immune from this increased governmental scrutiny. Your involvement in an investigation can potentially lead to ruinous civil fines, incarceration, and other criminal and administrative penalties. At the very least, an investigation can be costly and disruptive to your business.

Anticipating this trend of aggressive enforcement, Mintz Levin in 2009 formed its Health Care Enforcement Defense Practice comprised of health law and white collar defense attorneys with experience in government investigations and regulatory compliance matters. Many attorneys in this practice have served in government agencies, including the US Department of Health and Human Services and Department of Justice, or as assistant US attorneys and state assistant attorneys general.

Our lawyers regularly defend clients in civil and criminal matters in federal and state jurisdictions across the country. The types of cases we handle often involve one or more of the following allegations:

  • Offering or receiving kickbacks and other financial inducements
  • Filing of false claims with government health insurance programs
  • Marketing of drugs and devices in a manner that contravenes the Food, Drug, and Cosmetic Act
  • Maintaining financial relationships that constitute unlawful conflicts of interest
  • Upcoding, double billing, billing for services not rendered or not medically necessary, or altering expiration dates on prescription drugs
  • Rendering substandard care

The lawyers in our Health Care Enforcement Defense Practice have also advised on many voluntary disclosures and have negotiated numerous Corporate Integrity Agreements, including novel agreements of first impression.

We can assist your company in conducting internal investigations to find and correct problems before the government becomes involved. Clients also turn to us to design and implement corporate compliance and training programs, including developing policies and procedures to ensure ongoing compliance with fraud and abuse laws in high-risk areas, such as billing, sales, and marketing. In the transactional context, our lawyers conduct health care regulatory due diligence reviews for buyers and sellers of health care companies.

Sort by: Name  Title  Office

Representative Experience

  • Obtained acquittals of pharmaceutical manufacturer employees in two federal criminal Anti-Kickback Statute Cases.
  • Secured a criminal declination in an Anti-Kickback Statute Case for a pharmaceutical manufacturer from a US Attorney’s Office known for its aggressive prosecutions.
  • Obtained a reversal in a criminal cost report fraud case from the US Court of Appeals for the Fifth Circuit.
  • Persuaded the US Department of Justice to decline a False Claims Act case brought by whistleblowing former senior executives of a diagnostics company, building on the firm's experience in obtaining declinations of qui tam cases.
  • Cooperated with a quality of care joint civil and criminal investigation of a health care provider by a number of Assistant US Attorneys who ended the investigation early on without taking action, based on the evidence supplied by the provider.
  • Settled False Claims Act cases brought against numerous types of providers and manufacturers for pennies on the dollar.
  • Disclosed a hospital's Stark Law violation and Medicare overpayment to a Medicare contractor.
  • Represented a recipient of NIH grants in a federal investigation concerning potential grant fraud.
  • Negotiated a new type of Corporate Integrity Agreement with the Office of Inspector General on behalf of a medical device manufacturer.