On January 23, 2025, the United States Court of Appeals for the Fourth Circuit rejected a challenge to Advisory Opinion 22-19 (the “Advisory Opinion”) issued by the United States Department of Health and Human Services, Office of Inspector General (“OIG”). The case, Pharmaceutical Coalition for Patient Access v. United States, centered on whether the
On February 20, 2025, during a speech to the Federal Bar Association’s annual qui tam conference, Michael Granston, Deputy Assistant Attorney General for the Commercial Litigation Branch at the U.S. Department of Justice (DOJ), said that the Trump Administration will seek to “aggressively” enforce the False Claims Act (FCA). In particular, Granston stated that active
In United States ex rel. Feliciano v. Ardoin, the D.C. Circuit joined every other circuit to consider the issue, holding that a pro se litigant cannot bring a False Claims Act (FCA) case. The court’s reasoning was straightforward: FCA claims belong to the government, not the relator. While individuals may represent themselves in legal matters,
On Jan. 7, 2025, the Department of Justice announced that R&K Enterprises agreed to pay over $2.6 million to resolve allegations under the False Claims Act, 31 U.S.C. §§ 3729-3733, among other causes. The settlement was predicated on allegations that the company represented it was a small business eligible for certain small business set-aside contracts
On September 24, 2024, the Department of Health and Human Services Office of Inspector General (“OIG”) published a report (the “Report), reviewing and recommending increased oversight of remote patient monitoring (“RPM”) services and billing in the Medicare program. In the Report, OIG focused on three main issues: (1) Patients and providers are not using RPM
Recently, in United States ex rel. Kyer v. Thomas Health Systems, the judge overseeinga whistleblower’s False Claims Act (FCA) suit against Thomas Health Systems Inc. stalled further decisions until both parties could file supplemental briefs addressing the U.S. Supreme Court’s decision in Loper Bright Enterprises v. Raimondo. The judge’s order requires the parties to articulate
On July 9, 2024, McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (“PE”) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space.
Last month, the U.S. District Court for the District of New Jersey held that a private company, Allstate Insurance Company, could proceed with its whistleblower action against a clinical laboratory, Phoenix Toxicology and Lab Services, LLC, which allegedly submitted false claims to the federal government for medically unnecessary urine drug tests (“UDT”). See generally United
The Centers for Medicare & Medicaid Services (CMS) recently released data on its 2023 settlements of voluntary self-disclosures related to past violations or potential violations of the physician self-referral law (the Stark Law). In 2023, CMS settled an agency record 176 self-disclosures, with settlement amounts totaling over $12,000,000 in the aggregate. Both totals exceeded its
On Feb. 21, the Office of Inspector General of the U.S. Department of Health and Human Services announced the first four subsectors for which it will publish industry segment-specific compliance program guidance. Guidance published in 2024 will focus on Medicare Advantage and nursing facilities. Subsequent guidance will focus on hospitals and clinical laboratories.