On July 20, a jury in Massachusetts convicted former Acclarent executives William Facteau and Patrick Fabian of 10 misdemeanor counts of misbranding and adulteration based on alleged off-label promotion of the Stratus sinus spacing device. They were acquitted of 14 related felony charges, but they have vowed to fight the misdemeanor convictions in future motions and appeals. The Facteau verdict contrasts with the clean sweep obtained by Vascular Solutions and its CEO, Howard Root, last February, when a Texas jury acquitted them of all counts of misbranding and conspiracy for allegedly promoting the Vari-Lase varicose vein device off-label. The two cases are different in significant respects, which may account for the disparate results. But they also bear many similarities, which provide a road map for medical device and pharma manufacturers to future off-label prosecutions in the wake of recent First Amendment precedents.
Health Care Fraud & Compliance
We are a cross-disciplinary team that represents hospitals, device manufacturers, clinics, physicians, and other health-care providers in civil and criminal investigations and litigation, Medicare and Medicaid overpayment claims and appeals, and the development of compliance plans.
Recent Off-Label Device Cases Are A Road Map For The Future, published by Law360
What We Do
We help clients work with health care regulators and respond to investigations involving the FBI, Department of Justice, Department of Health and Human Services Office of the Inspector General (HHS-OIG), State Attorneys General, Food and Drug Administration, and other governmental agencies. We have successfully represented numerous clients in criminal health care fraud trials, qui tam litigation, Medicare “upcoding,” medical necessity and documentation cases, hearings before professional boards, and national health care fraud initiatives. We help our clients understand how state and federal regulations will affect their personal and business interests and work with them to protect those interests.
- Anti-Kickback and Stark
- Attorney General Investigations
- Civil Investigations and Litigation
- Clinical Trials
- Criminal Investigations and Litigation
- FDA Investigations and Litigation
- Internal Investigations
- Investigations by the HHS Office of the Inspector General, FBI and DOJ
- Medical Necessity Cases
- Medicare and Medicaid Disputes and Investigations
- Overpayment Claims and Appeals
- Professional Board Hearings
- Research Grants
- Upcoding Cases
The following is a representative list of our clients:
- 80+ surgeons sued in federal False Claims Act anti-kickback litigation.
- A nursing home prosecuted for a patient’s death. Our representation resulted in dismissal of felony charges.
- A nursing home chain prosecuted for fraud in submitting cost reports that allegedly contained personal, non-reimbursable items. After we submitted legal argument and documentation, the criminal charges were dismissed.
- A medical device company raided by agents of the FBI who had received a tip from a disgruntled employee that records had been falsified and test results misreported. After careful investigation, we persuaded the government that charges should not be brought.
- A well-respected surgeon prosecuted for allegedly illegally charging third-party payors for an investigational new drug. As a result of our thorough investigation and persuasive presentation of the evidence at trial, the court threw out the charges.
- The CEO of a device manufacturer prosecuted for conspiracy and health-care fraud. After seven weeks of trial, all felony charges were dropped.
- A major academic health center sued for illegally seeking Medicare reimbursement for investigational devices. The case was dismissed, without any payment.
- A medical clinic investigated by the FBI and DOJ for allegedly upcoding charges. The investigation was dropped and the related qui tam suit dismissed based upon our presentation.
- An audiologist faced with a $70,000 Medicare overpayment claim based on allegations the service was not medically necessary. After appeal, the alleged overpayment was reduced to approximately $10,000.
- A clinical lab faced with a $300,000 Medicare overpayment claim. After a hearing, the overpayment was reduced by more than half.
News & Articles
February 12, 2016
Today CMS published a final rule detailing the duty to report and return overpayments with 60 days of their identification. The “report and return” requirement was adopted by Congress as part of the Affordable Care Act. This final rule is the first regulation from CMS interpreting the statute. The final rule makes it clear that the 60-day period does not begin to run until you have quantified the amount of the overpayment, or, when you should have quantified the overpayment had you been acting diligently. In other words, the 60-day clock does not start to run when you first discover a potential billing problem.