Health Law Highlights

The OIG issued a favorable advisory opinion allowing a medical device manufacturer to subsidize Medicare cost-sharing obligations for patients enrolled in a clinical trial testing an…

Aetna Inc. agreed to pay $117,700,000 to resolve allegations that it violated the False Claims Act by submitting inaccurate diagnosis codes for Medicare Advantage enrollees to…

The Office of Inspector General approved an arrangement allowing a management company affiliated with urgent care centers to establish an independent clinical laboratory without violating the…

The FDA issued a warning about Generation 1 Purge Cassettes in Johnson & Johnson MedTech’s Impella heart pumps after the components were linked to 4 injuries.…

The DOJ Antitrust Division awarded its first whistleblower payout of $1 million to an individual who exposed a bid rigging and fraud scheme at EBlock Corp.’s…

Texas Attorney has launched an investigation into what he describes as potentially the largest data breach in U.S. history, issuing Civil Investigative Demands to Blue Cross…

Ambulatory surgery centers now treat patients with conditions far beyond their original design parameters. ASCs increasingly care for patients with diabetes, obesity, cardiovascular disease, arrhythmias, anticoagulation…

Reference product exclusivity grants biological products 12 years of market protection under the Biologics Price Competition and Innovation Act, during which the FDA will not approve…

Epic Systems filed 29 affirmative defenses against Texas Attorney General Ken Paxton’s antitrust lawsuit, arguing the state’s claims are invalid under the Texas Deceptive Trade Practices…

A federal judge issued a preliminary injunction on December 29, 2025 halting the Department of Health and Human Services’ 340B Rebate Model Pilot Program, which was…