Two recent federal cases are providing insight into what to expect in state court litigation related to information blocking, defined in the 21st Century Cures Act (Cures Act) as a practice that interferes with the access, exchange, or use of electronic health information.
On March 12, 2025, the Fourth Circuit upheld the Maryland District Court’s…
The United States Court of Appeals for the Seventh Circuit recently reversed the conviction of Mark Sorensen, the owner of SyMed Inc., a Medicare-registered distributor of durable medical equipment (DME), for alleged violations of the federal Anti-Kickback Statute (“AKS”). This case, described by the court as one that “tests some of the outer boundaries” of…
On February 28, the Department of Health and Human Services (HHS) announced that it was rescinding the Richardson Waiver, a policy in place since 1971 which said HHS would provide notice of proposed rulemaking in certain cases where it was not otherwise required to do so by law. This announcement signals a policy shift…
The United States Court of Appeals for the First Circuit issued a pivotal ruling earlier this week, finding that in order to establish falsity in a False Claims Act (“FCA”) case premised on Anti-Kickback Statute (“AKS”) liability, the kickback must have been the “but-for” cause of the submission of the claim. The court’s decision hinged…
On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use…
Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”). Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws. Last week, the United…
The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals. The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud…
In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.…
The United States District Court for the Eastern District of Michigan recently dismissed a False Claims Act (“FCA”) lawsuit brought against the City of Detroit. The core issue in United States ex rel. Lynn v. City of Detroit revolved around Detroit’s annual certifications and assurances to comply with federal laws and regulations as a condition…
United States of America v. Sutter Health is exemplary of the delicate balance courts must strike when dealing with attorney-client privilege. Here, the United States District Court for the Northern District of California denied the relator’s motion for determination as to waiver of privilege, but granted alternative relief.
This case involves alleged violations of…
