Arent Fox utilizes an integrated approach to health care investigations. We pair attorneys from our Health Care practice, who are highly experienced in the myriad of federal, state, and local health care regulations, with our White Collar and Investigations practice group, composed of seasoned former prosecutors and regulatory counsel, to create an effective and formidable team with significant experience in handling health care- related investigations.
Our White Collar team has successfully defended health industry clients in criminal investigations and prosecutions and civil False Claims Act litigation. Our experience includes conducting internal investigations; presenting findings to boards of directors and outside auditors; responding to search warrants and government subpoenas; preparing clients to testify before grand juries; negotiating criminal and whistleblower settlements; testifying before Congressional Committees; and preparing and presenting voluntary disclosures to the government. We have a seasoned bench of trial attorneys with broad experience in making pre-charging presentations to government entities and mounting vigorous defenses at trial. Our attorneys also understand the need to protect patient privacy during the course of an investigation; and they appreciate the public relations impact that can result from a government investigation and assist clients in responding to media inquiries.
We have represented:
- Hospitals
- Hospices
- Medical device companies
- Academic medical centers and individual clinical researchers
- Health care providers and suppliers
- Health care practitioners
We have experience defending allegations of:
- Billing and coding fraud
- Certifications of eligibility
- Failure to comply with conditions of Medicare or Medicaid payments
- Anti-Kickback Act and False Claims Act violations
- Physician self-referral (Stark Law) violations
- False certification of medical necessity
- Clinical research fraud
- Whistleblower retaliation
- Patient dumping
When faced with a government investigation, one of the first lines of defense is a strong compliance program. Our integrated team works with clients to design robust compliance programs that can withstand government scrutiny and provide a strong defense to allegations of misconduct. We also assist clients in establishing protocols for responding to government investigations, including the execution of a search warrant, the service of subpoenas, and the receipt of letter requests from various federal and state enforcement entities.
FDA Enforcement
Arent Fox represents manufacturers and distributors of pharmaceuticals, medical devices, cosmetics and chemical products, and food and dietary supplements. We advise and represent clients with respect to the manufacture and marketing of various drug and biologic products. We have significant experience in a wide variety of matters involving the US Drug Enforcement Administration (DEA) and the US Food and Drug Administration (FDA) and its Office of Criminal Investigations (OCI) which investigates criminal violations of the Food, Drug, and Cosmetics Act (FDCA).
