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
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Seventh Circuit Clarifies Limits on Advertising Payments under the AKS
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…
HHS Suggests It Will Provide Less Notice and Opportunity for Comment on Grant and Contract Rules
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…
First Circuit Clarifies “Resulting From” standard under Anti-Kickback Statute, Reshaping False Claims Act Litigation
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…
FDA Proposes Framework to Assess AI Model Output Credibility to Support Regulatory Decision-Making
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Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To…
Stringent Requirements for Pleading Fraud Under Rule 9(b).
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…
General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss
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…
The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services
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…
Future Promises of Compliance with Federal Laws Cannot Form the Basis of a False Claims Act Violation
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…
How much (information) is too much? Caselaw shines a light on avoiding privilege waiver.
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…