HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
In a cautionary tale for health care entities, the U.S. Attorney’s Office for the Eastern District of North Carolina recently announced the convictions of two health care executives who admitted to orchestrating a multi-year...more
This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2025, including the results of the US Department of Justice’s (DOJ) 2025 National Health Care Fraud Takedown, DOJ...more
The federal government has demonstrated that it is more than willing to use the United States criminal code to prosecute home care agencies that pay unlawful financial inducements to generate referrals in violation of the...more
The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the next phase of the Administration’s “Whole-of-Government” approach to fighting health care...more
On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
On November 22, 2023, while many were preparing for the Thanksgiving holiday, the Office of Inspector General (OIG) posted a consumer alert (Alert) warning the public about a fraud scheme involving monthly billing for remote...more
On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more
Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...more
This opinion addresses a proposed agreement (“Proposed Arrangement”) between a national anatomic pathology laboratory (“Requestor”) and laboratories owned in whole or in part by physicians who may refer (“Referring...more
The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion on Aug. 15, 2023, involving an intraoperative neuromonitoring (IONM) services arrangement. The Advisory...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
DOJ Announced Results of Nationwide COVID-19 Fraud Enforcement - On Wednesday, August 23, 2023, the US Department of Justice (DOJ) announced the results of a coordinated, nationwide enforcement action to combat COVID-19...more
In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more