February 14, 2026 This week Drug & Device Fraud & Abuse HIPAA Hospitals Labor & Employment Med Spas Medicare Reimbursement Mergers & Acquisitions Overpayments Privacy Reproductive Rights Substance Abuse - Part 2 Drug & Device 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 biosimilar applications referencing the product. The FDA may not issue licensure of a...
11 days ago • 10 min read
February 14, 2026 This week Antitrust Cybersecurity Data Privacy Emerging Tech Fraud & Abuse Labor & Employment Mergers & Acquisitions Medicaid Antitrust 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 Act. The electronic health record vendor stated that healthcare organizations, not Epic, serve as legal custodians of medical records and determine patient...
18 days ago • 10 min read
February 14, 2026 This week 340B Artificial Intelligence Compliance Drug & Device Fraud & Abuse HIPAA Medicaid OIG Advisory Opinion Part 2 SUD Private Equity Telehealth 340B 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 set to launch January 1, 2026. The program would have restructured the 340B Drug Pricing Program from upfront discounts to post-sale rebates for ten drugs...
25 days ago • 12 min read
February 14, 2026 This week Advisory Opinions Artificial Intelligence Commercial Payers Enforcement HIPAA Medicare Reimbursement Private Equity Physicians Rural Health Advisory Opinions The Department of Health and Human Services Office of Inspector General issued Advisory Opinion 25-11 addressing whether a biopharmaceutical manufacturer’s vaccine discount arrangements would violate the federal Anti-Kickback Statute. The manufacturer sought guidance on four types of discounts for three...
about 1 month ago • 10 min read
February 14, 2026 This week 340B AI Legislation Clinical Laboratories Employers Data Privacy Fraud & Abuse HIPAA Medicare Reimbursement Mergers & Acquisitions No Surprises Act Reproductive Rights Restrictive Covenants Rural Health 340B A federal district court has blocked the Health Resources and Services Administration from implementing a 340B Rebate Model Pilot Program, days before its January 1, 2026 start date. The court found HRSA likely violated the Administrative Procedure Act by...
about 1 month ago • 14 min read
February 14, 2026 This week Antitrust Artificial Intelligence Enforcement HIPAA Reimbursement Risk Management Telehealth This will be the last newsletter of 2025. I'll see you all again on January 6, 2026. I hope you have a wonderful holiday season and New Year! Antitrust Texas Attorney General Ken Paxton filed a lawsuit against Epic alleging the company monopolizes the electronic health record market and restricts parental access to children’s medical records. The lawsuit claims Epic, which...
2 months ago • 6 min read
February 14, 2026 This week Ambulatory Surgery Centers Dentistry Food & Drug Administration Fraud & Abuse HIPAA Med Spa and Medical Aesthetics Medical Privacy MedTech Private Equity Ambulatory Surgery Centers Ambulatory surgery centers are becoming essential to health system growth strategies as clinical, financial, regulatory, and competitive forces push care beyond hospital walls. Technology improvements and post-pandemic comfort with higher-acuity procedures have made ASCs viable for...
2 months ago • 8 min read
February 14, 2026 This week Antitrust Centers for Medicare & Medicaid Services Data Privacy and Breach HIPAA Non-Competes Telehealth Antitrust U.S. Judge Jeffrey Cummings denied the Federal Trade Commission’s request to block GTCR LLC’s $627 million acquisition of Surmodics Inc. on November 10. The FTC, joined by Illinois and Minnesota, argued the merger would give GTCR control of more than 50% of the U.S. outsourced hydrophilic coatings market, as GTCR already owns Biocoat, the second...
2 months ago • 4 min read
February 14, 2026 This week 340B Artificial Intelligence Cybersecurity Drugs & Devices Fraud & Abuse Hospitals Medicare Part 2, Substance Abuse Workforce 340B HRSA has approved plans from 10 manufacturers to participate in the 340B Rebate Model Pilot Program, which will inform the development of future models consistent with the 340B statute. The participating manufacturers include Bristol Myers Squibb (Eliquis), Immunex Corporation (Enbrel), AstraZeneca (Farxiga), Pharmacyclics (Imbruvica),...
3 months ago • 10 min read