On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more
First Circuit Joins Sixth and Eighth Circuits in Adopting Heightened, But-For Causation Standard for AKS-Based FCA Claims - On February 18, the US Court of Appeals for the First Circuit became the latest court to agree...more
The reach of the Anti-Kickback Statute and the False Claims Act is broad. As a result, AKS liability is a real and significant risk for healthcare companies and providers. Healthcare companies and providers have to resolve...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to...more
Many compound pharmacists who participated in the TRICARE program learned, in the most painful of ways, that the Department of Justice (DOJ) casts a very long shadow when large amounts of money pour out of a government...more
On September 18, 2019, the Department of Justice (DOJ) announced a $21.36 million settlement with compounding pharmacy Patient Care America (PCA), as well as PCA’s Chief Executive, PCA’s former Vice President of Operations,...more
On March 18, 2019, the Department of Justice (DOJ) filed an amended complaint-in-intervention in the False Claims Act (FCA) case against Diabetic Care Rx, LLC d/b/a Patient Care America (PCA); two of PCA’s executives; and the...more
The scope of our country’s opioid epidemic is devastating. From 1999 to 2017, more than 700,000 people have died from a drug overdose. Two-thirds of these deaths involved an opioid. On average, 195 Americans dies every day...more
Recently, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced its largest ever national health care fraud takedown, resulting in charges against 601 diverse defendants including...more
• In an unusual move, the government has decided to pursue a False Claims Act (FCA) suit against a private equity firm based on an alleged commission scheme at its pharmacy portfolio company to promote sales of products...more
The U.S. Attorney for the Southern District of Florida has recently decided to intervene in a lawsuit brought under the Federal False Claims Act and initiated by a whistleblower. The U.S. Attorney has filed his own...more
In February, the Department of Justice (DOJ) intervened in a False Claims Act case alleging healthcare fraud, a common enough event. The case in question, originally began in 2015 as a whistleblower case brought by two...more
The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more