Health Care Enforcement Defense 

In recent years, federal and state agencies have placed increasing emphasis on investigating and prosecuting health care fraud, and the Obama Administration has promised aggressive enforcement. In response, Mintz Levin has expanded its health care fraud and abuse practice by forming the Health Care Enforcement Defense Group.

The group includes 20 attorneys from the firm's Health Law and White Collar Defense practices, with expertise in government investigations and regulatory compliance matters. Many attorneys in this group have served in government agencies, including the United States Department of Health and Human Services and Department of Justice, or as Assistant United States Attorneys and state Assistant Attorneys General.

The attorneys in our Health Care Enforcement Defense Group have extensive experience in defending alleged violations of laws prohibiting the:

• Offering or receipt of 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
  
• Maintenance of financial relationships that constitute unlawful conflicts-of-interest
  

A substantial number of these types of cases begin with complaints from whistle-blowers. 

We have represented hospitals, clinics, skilled nursing facilities and other long term care providers, managed care organizations, physicians, retail pharmacies, pharmacy benefits managers, independent laboratories, and pharmaceutical and medical device manufacturers, and their officers and employees, among others.

Investigations

Mintz Levin has helped clients avoid potentially ruinous civil fines, incarceration, and other criminal and administrative penalties by combining our regulatory knowledge with our investigative and litigation expertise.

We regularly assist clients in conducting internal investigations to find and correct problems before the government becomes involved, thereby helping our clients avoid government action in the first instance. This process typically involves document review, audit oversight, witness interviews, and, when necessary, retention of experts and consultants. Among other issues, we can address complex questions involving attorney-client privilege and attorney work product self-disclosures, and advise clients on what steps to take when internal investigations precede government investigations and audits.

We have represented clients in federal and state government investigations across the country, including matters initiated by the Department of Justice’s Civil Fraud Section or the Criminal Division, United States Attorneys, state Attorneys General, the Office of Inspector General (OIG) for the Department of Health and Human Services, the Drug Enforcement Administration, and the Medicaid Fraud Control Units in all 50 states.

Litigation

When litigation has arisen, we have defended clients in civil and criminal matters in more than 20 key federal jurisdictions, including Arizona, the Central and Northern Districts of California, Colorado, the District of Columbia, the Southern District of Florida, Georgia, the Northern District of Illinois, Indiana, Maryland, Massachusetts, the Western District of Michigan, Missouri, New Hampshire, New Jersey, New Mexico, the Eastern and Southern Districts of New York, North Dakota, Oregon, the Eastern District of Pennsylvania, the Eastern District of Tennessee, Texas, Vermont, and Washington.

Recent Successes

Our attorneys recently obtained these successful outcomes, among many others:

• Secured acquittals in two federal criminal cases alleging violations of the anti-kickback act and federal program fraud
  
• Settled False Claims Act cases involving pharmaceutical and device manufacturers and direct providers of care for a fraction of the amounts originally demanded by the government
  
• Secured a criminal declination for a pharmaceutical manufacturer under investigation for alleged kickback violations from a United States Attorney’s Office known for its aggressive prosecutorial stance 
  
• Obtained a reversal of a criminal cost report fraud case in the United States Court of Appeals for the Fifth Circuit
  
• Obtained an acquittal for one of the individual defendants in the government’s prosecution of TAP Pharmaceutical Products Inc. for fraudulent drug pricing and marketing
  
• Persuaded United States Attorneys’ Offices to decline cases brought by whistleblowers

We have also:

• Counseled clients involved in quality of care cases
  
• Defended alleged violations of the Food, Drug, and Cosmetic Act
  
• Defended allegations of cost report, Stark, and kickback violations
  
• Represented clients faced with assertions of upcoding, double billing, billing for services not rendered or not medically necessary, altering expiration dates on prescription drugs, and criminal patient abuse
  
• Defended pharmaceutical companies and other health care clients in investigations concerning drug price reporting and unlawful Medicaid reimbursement
  
• Assisted health care providers and other clients acting as government contractors in dealing with retrospective audits and challenging recoupment actions
  
• Negotiated numerous Corporate Integrity Agreements, including novel CIAs of first impression

In addition to these matters, our attorneys have been involved in almost every major government investigation of laboratories since 1992.

Please click here to view a pdf of our Health Care Enforcement Defense practice brochure.

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For more information on our Health Care Enforcement Defense practice, please contact Hope S. Foster, Practice Group Chair.

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