Monitoring the Pulse of Health Care and Life Sciences
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
On June 1, 2023, the U.S. Supreme Court issued a unanimous opinion in the highest-profile False Claims Act (FCA) case for many years, concluding that a party’s subjective belief as to whether it overcharged Medicare and Medicaid…
On March 29, 2023, the Department of Justice’s (DOJ) Office for the Eastern District of Michigan announced a notable set of three settlements (collectively, the Settlement) in excess of $69 million dollars total with a regional hospital system (Hospital) and two individual physicians, respectively.…
On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule (Proposed Rule) which proposes certain policy and technical changes to Medicare regulations, including a notable change to the current standard under the “60-Day Rule” for identifying a Medicare overpayment. Specifically, CMS indicated that it is proposing to (i) “adopt by reference” the federal False Claims Act’s (FCA) definitions of “knowing” and “knowingly” as governing when an overpayment is identified, and (ii) eliminate the “reasonable diligence” standard that has been in place, but subject to challenges, for a number of years.…
On October 17, 2022, the United States Department of Justice (DOJ) announced a $13 million settlement with health care services provider Sutter Health, which arose from alleged violations of the federal False Claims Act (FCA). These alleged FCA violations relate to Sutter Health billing the United States for toxicology screening tests performed by other labs.…
Continue Reading DOJ Announces $13 Million Settlement Related to Improper Billing for Lab Tests
On October 17, 2022, the Supreme Court denied certiorari in three cases asking the court to resolve a circuit split regarding the application of the particularity pleading requirement for allegations of fraud in False Claims Act (FCA) cases, as required under Federal Rule of Civil Procedure 9(b). The cases are: Johnson, et al. v. Bethany Hospice, 21-462; U.S., ex rel. Owsley v. Fazzi Associates, Inc., et al., 21-936; and Molina Healthcare, et al. v. Prose, 21-1145. Molina also presented a second question over which circuits had split, regarding the correct interpretation of Universal Health Services, Inc. v. United States ex rel. Escobar and whether a request for payment without specific representations can be actionable under an implied false certification theory. (Petition for Writ of Certiorari).…
Continue Reading Supreme Court Denies Certiorari in Three FCA “Particularity” Cases
On October 18, 2022, the Department of Justice (DOJ) announced two settlements with CHC Holdings, LLC, an Oklahoma limited liability company doing business as Carter Healthcare (Carter), and two former senior corporate officers, resolving alleged violations of the federal False Claims Act (FCA), Anti-Kickback Statute (AKS), and Physician Self-Referral Law (commonly referred to as the “Stark Law”). One case settled claims that Carter had made improper payments to referring physicians in Oklahoma and Texas, while the other case settled claims that Carter had made false billing claims in Florida. Both matters were initiated by qui tam whistleblower complaints filed under the FCA. Carter agreed to pay more than $30 million to resolve the allegations.…
On September 26, 2022, the United States Department of Justice (DOJ) announced a $900 million settlement with pharmaceutical company Biogen Inc., which arose from alleged violations of the federal False Claims Act (FCA) and Anti-Kickback Statute (AKS) tied to payments from the company to physicians, which were allegedly intended to induce prescription of Biogen’s drugs. The matter initiated as a qui tam whistleblower complaint filed by an employee under the FCA.…
Continue Reading DOJ Announces $900 Million Settlement Tied to Speaker Bureau Payments to Physicians
Below is an excerpt of a contributed article co-authored with Robinson+Cole Business Litigation Group lawyer Ben Daniels published in Physicians Practice on September 16, 2022.
On July 25, 2022, the U.S. Court of Appeals for the Second Circuit rejected an appeal brought by Pfizer, Inc. in a case that examines whether a “corrupt” intent is…
The Department of Health and Human Services Office of Inspector General (OIG) recently released a Data Brief summarizing the findings of a review of program integrity risks related to telehealth services reimbursed by Medicare during the first year of the COVID-19 pandemic (the Pandemic).[1] The OIG analyzed Medicare and Medicare Advantage claims data from March 1, 2020, to February 28, 2021, focusing on providers that billed for telehealth services, with an emphasis on identifying providers that posed a high risk to the Medicare program.…
HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of individuals criminally for their participation in an allegedly fraudulent scheme related to telemedicine, laboratories, and durable medical equipment (“DME”).[1] However, the alert comes after focus on telemedicine fraud cases in particular since 2019. The Special Fraud Alert identifies several characteristics of concern and common elements that individuals and companies should be aware of.…
Continue Reading Suspect Characteristics Identified under a Telehealth Special Fraud Alert
