For several years now, the United States Department of Justice (“DOJ”) has indicated an increased desire to exercise its dismissal authority over qui tam actions, even over the objections of relators who initially brought the claims. However, the slight uptick
Health Law
Analysis, commentary, and the latest developments in health care law and policy
Blog Authors
Latest from Health Law
Significant Implications for FCA Defendants: Second Circuit Clarifies “Willfulness” in McKesson Decision
In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”).…
Monumental Reduction in FCA Damages Based on Excessive Fines Clause
In a recent landmark decision, the United States District Court for the District of Minnesota dramatically reduced the damages and penalties awarded in a major False Claims Act (“FCA”) case. United States of America ex rel. Kipp Fesenmaier v. The…
The Complexities of Assessing Damages in FCA Cases
Calculating and predicting damages in a False Claims Act (“FCA”) case can be a daunting task for the most seasoned FCA practitioners. In fact, even judges presiding over years of litigation and weeks of trial can get it wrong by…
ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final…
OIG Issues Updated General Compliance Program Guidance: Overview of Key Elements & Changes
The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective…
OCR Takes Enforcement Action for Phishing Attack
Last week, the Office for Civil Rights (“OCR”) announced a settlement with Lafourche Medical Group (“LMG”), a Louisiana medical group, for a 2021 phishing attack and breach that affected the protected health information (“PHI”) of 34,862 individuals. In addition to…
Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care
On November 8, 2023, the Senate Health, Education, Labor and Pensions (HELP) Committee Subcommittee on Primary Health and Retirement Security discussed the impact of artificial intelligence (AI) on the healthcare sector in the Committee’s second AI hearing in nine days.…
OCR Issues Guidance to Providers and Patients on Telehealth Privacy and Security
Last week, the Office for Civil Rights (“OCR”) issued two pieces of guidance on the privacy and security of protected health information (“PHI”) when using telehealth services. One of the documents is intended to help health care providers explain to…
HHS Aims to Strengthen Anti-Discrimination Rules for Disabled Patients in New Proposed Rule
On September 14, 2023, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule updating Section 504 of the Rehabilitation Act of 1973 (“Section 504”). The new rule entitled Discrimination on the Basis of Disability in Health…