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Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.”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
Health Law
Analysis, commentary, and the latest developments in health care law and policy
Blog Authors
Latest from Health Law
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 practices under the False Claims Act (“FCA”) and analogous state laws. Last week, the United…
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 Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud…
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 qui tam FCA claims.…
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 Detroit’s annual certifications and assurances to comply with federal laws and regulations as a condition…
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 to waiver of privilege, but granted alternative relief.
This case involves alleged violations of…
The Intricacies of Qui Tam Actions and the Role of Government Dismissals
In the world of legal battles, few are as complex and as fraught with procedural intricacies as qui tam actions brought under the False Claims Act (“FCA”). The qui tam provision of the FCA allows private individuals, known as relators, to file lawsuits on behalf of the government and if successful, relators can receive a…
Navigating the Attorney-Client Privilege Waiver Tightrope
The United States District Court for the District of Rhode Island cast a spotlight on the doctrine of implied waiver of attorney-client privilege in a recent False Claims Act (“FCA”) case. The case, United States of America ex rel. James R. Berkley v. Ocean State, LLC, et al., Case No. 20-538-JJM-PAS (D.R.I., June 26, 2024),…
Healthcare Providers Who Engage in Information Blocking Will Face Disincentives Described in an HHS Final Rule
On June 24, 2024, the Department of Health and Human Services (“HHS”) released a final rule (“Disincentives Final Rule”) establishing disincentives for certain healthcare providers that have committed information blocking. The information blocking disincentives directly impact Medicare-enrolled healthcare providers or suppliers including hospitals, critical access hospitals, MIPS-eligible clinicians, and ACOs. The Disincentives Final Rule has…
Settling False Claims Act Cases Involves More than Just Cutting a Check to DOJ
In late March 2023, Dr. Paul Koch, the former owner of a chain of Rhode Island ophthalmology practices, agreed to pay $1.1 million to the U.S. Attorney’s Office to settle false claims act allegations. This case arose from a qui tam complaint brought by two whistleblowers alleging that over a five-year period, Koch paid kickbacks to optometrists…