Monitoring the Pulse of Health Care and Life Sciences
*This post was co-authored by Lily Denslow, legal intern at Robinson+Cole. Lily is not admitted to practice law.
On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care fraud schemes alleged to…
This post is co-authored by Seth Orkand, co-chair of Robinson+Cole’s Government Enforcement and White-Collar Defense Team.
On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical practices in North Carolina…
On November 15, 2023, the U.S Department of Justice (DOJ) announced a $45.6 million consent judgment (Settlement) with six skilled nursing facilities (SNFs), as well as the owner of the SNFs and its management company which managed the SNFs, to resolve alleged violations of the False Claims Act (FCA) tied to medical director arrangements violating the Anti-Kickback Statute (AKS). The Settlement is notable for its inclusion of the owner and the management company in addition to the SNFs, which indicates DOJ’s interest in scrutinizing the actions of individuals and management entities in connection with problematic arrangements under federal fraud and abuse laws.Continue Reading DOJ Settlement Targets Owner and Management Company in Addition to Post-Acute Care Facilities
As the year comes to a close, the government has signaled a specific focus on clinical laboratories for 2023. On December 6, 2022, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued a Report entitled, “Labs With Questionably High Billing for Additional Tests Alongside COVID-19 Tests Warrant Further Scrutiny” (Report). The Report discusses why the study pertaining to the billing of additional tests alongside COVID-19 testing was conducted, how it was conducted, and what the key takeaways of the study are. This was followed by OIG’s issuance in mid-December of a Data Brief reviewing Medicare Part B spending on lab tests entitled, “Medicare Part B Spending on Lab Tests Increased in 2021, Driven by Higher Volume of COVID-19 Tests, Genetic Tests and Chemistry Tests” (Data Brief). Continue Reading OIG Issues Reports Reviewing Laboratory Billing Practices and Noting Increased Spending by Medicare Part B on Laboratory Tests
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 September 6, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-17 (Advisory Opinion), in which it declined to impose sanctions against a regional 501(c)(3) not-for-profit health care system that operates four hospitals (Health System) and a clinic that provide services to geographic areas that have been designated as medically-underserved areas and health professional shortage areas (together, the Requestors). The Health System had supported the establishment of the clinic, which is registered as a Free Clinic and been designated as a Federally Qualified Health Center (FQHC) Look-Alike (Clinic), (but is neither a FQHC nor does it receive funds under Section 330 of the Public Health Service Act). The arrangement involves the forgiveness of a credit line note entered into by the Health System with the Clinic. The OIG concluded that although the arrangement would constitute prohibited remuneration under the federal anti-kickback statute (AKS) if the requisite intent were present, the arrangement and the safeguards in place did not warrant the imposition of sanctions.Continue Reading Advisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by Clinic
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.Continue Reading Home Health Company and Two Corporate Officers Settle False Claims Act Allegations for Over $30 Million
On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the imposition of sanctions under the federal anti-kickback statute (AKS). The OIG concluded that while beneficiary access to potentially life-saving medications is essential, the provisions of the proposed arrangement “would present more than a minimal risk of fraud and abuse” under the AKS.Continue Reading Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions
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
