Our attorneys have extensive experience defending health care providers in government investigations and civil and criminal litigation, including matters arising under the federal and state False Claims Acts, the Anti-Kickback Statute and Stark Law, the federal health care fraud statute and other criminal fraud statutes. Our clients include medical device and pharmaceutical manufacturers, hospitals and health care systems, home health agencies and physicians. We also defend health care executives and other individuals in criminal and civil investigations. In addition, we regularly assist clients with internal investigations of potential wrongdoing and with appropriate remedial action such as voluntary self-disclosure under the Department of Health and Human Services Office of Inspector General Self-Disclosure Protocol.

Our team consists of skilled litigators who have handled civil fraud and criminal health care matters in federal and state courts, and includes numerous former Assistant United States Attorneys and Department of Justice officials. Our lawyers regularly interact with health care enforcement officials from the Civil and Criminal Divisions of the Department of Justice, many of the United States Attorneys’ offices, the Office of Inspector General of the U.S. Department of Health and Human Services, the Centers for Medicare and Medicaid Services, and other agencies.

Much of the government’s health care fraud enforcement efforts involve investigating and pursuing actions filed by whistleblowers under the qui tam provisions of the False Claims Act (FCA), and we regularly defend FCA investigations and litigation on behalf of clients in the health care industry. In recent years, we have settled dozens of health care FCA cases, large and small, some for more than $100 million and others for less than $1 million. We also try FCA cases and litigate them through successful post-trial appeals.

In addition to our civil FCA practice, our lawyers have successfully defended clients, including executives, in criminal health care fraud cases, from investigation through trial.

As a result of our work litigating health care fraud matters and defending investigations, as well as through our collaboration with colleagues in other practice groups, our False Claims Act litigators have acquired deep knowledge of Medicare, Medicaid and other health care programs, as well as health care regulations.

Our representative matters include:

  • Represented a major pharmaceutical manufacturer in multiple FCA cases alleging off-label and other unlawful promotion of anti-psychotic medication.
  • Represented a large medical supply company and a home health agency in separate qui tam actions alleging violations of the Anti-Kickback Statute.
  • Defended hospitals in multiple different FCA matters alleging violations of the Anti-Kickback Statute and Stark Law, including in the context of hospital-physician joint ventures, physician practice acquisitions, physician employment agreements, medical directorships and other services agreements, and office space rental agreements.
  • Defending a large ambulance company in an FCA investigation of multiple issues, including medical necessity of transports and coding.
  • Defending multiple hospitals in an investigation into alleged unnecessary implantations of cardiac stents.
  • Defended multiple hospitals in government investigation alleging unlawful implantation of cardiac defibrillators.
  • Defended physician practices accused of upcoding and billing for medically unnecessary services.
  • Defended multiple hospitals in FCA matters alleging inappropriate inpatient admissions.
  • Defending a hospital in an investigation of alleged unnecessary ophthalmologic procedures.
  • Defended multiple hospitals accused of excessive charges intended to obtain additional Medicare outlier reimbursement.
  • Representing the business unit head of a pharmaceutical company in connection with a criminal investigation and multiple qui tam actions related to alleged off-label promotion of various medications.
  • Defended a hospital system in investigation of alleged false post-acute transfer-discharge coding.
  • Assisted clients with self-disclosures to the HHS-OIG under the HHS-OIG’s self-disclosure protocol, and negotiated civil money penalty settlements following self-disclosures.
  • Advising clients regarding compliance with Corporate Integrity Agreements entered into with the HHS-OIG.
  • Represented a former Division President of a national pharmacy company in a DOJ investigation of alleged violations of the Anti-Kickback Statute.
  • Assisting a 300-physician multi-specialty medical group in responding to a former executive’s allegation of inappropriate evaluation and management (E&M) coding and unlawful compensation arrangements.
  • Conducted multiple internal investigations for pharmaceutical companies involving alleged improper marketing activities under the Anti-Kickback Statute and FDA prohibition against off-label promotion.
  • Conducted internal investigations for a pharmaceutical company concerning allegations of improper medical device reporting and misconduct with respect to employee training programs.
  • Served as pool counsel representing several managers and employees of a major pharmaceutical company during criminal investigation of alleged off-label promotion of a prescription pain medication.
  • Represented a senior manager of a pharmaceutical company in a criminal investigation and multiple related qui tam actions in connection with alleged off-label promotion of various medications. Our client was not criminally charged.
  • Defended a medical school and the principal researcher in a qui tam action alleging misuse of federal research funds and scientific misconduct. The qui tam action was dismissed pre-trial.
  • Defended a nursing care facility in a qui tam action brought by several employee nurses.