When the three-judge panel of the Eleventh Circuit Court of Appeals heard oral argument last December, the word repeated through the courtroom was control. On September 1, 2026 the panel handed down a decision in which control plays almost no part at all. In United States ex rel. Zafirov v. Florida Medical Associates, LLC (Zafirov),[1] … Continue Reading
Data miner whistleblowers, increasingly armed with artificial intelligence (AI) tools, are already reshaping how False Claims Act (FCA) theories are built, generated, and litigated. The Department of Justice’s (DOJ) April 2026 announcement of the Fraud Oversight through Careful Use of Statistics (FOCUS) initiative, which will strengthen relationships with data miner relators who have developed “effective … Continue Reading
In November 2025 we published From Biologics to Bandages, Skin Substitutes Are No Longer the Biologics You Think They Are, flagging an unmistakable shift at the Centers for Medicare & Medicaid Services (CMS) toward constraining a massive increase in government spending on skin substitutes (the biological-based wound coverings used for burns, trauma, and chronic conditions … Continue Reading
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 16, 2026. The DOJ announced a record level of recoveries from FCA resolutions in Fiscal Year (FY) 2025 (ending Sept. 30, 2025), which exceeded $6.8 billion. These statistics reflect the highest single-year dollar amount recovery on-record since the DOJ … Continue Reading
In a September 3 Press Release, the U.S. Department of Health and Human Services (HHS) announced that it is increasing efforts to curb information blocking. This was quickly followed by a September 4 Enforcement Alert issued jointly by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (ASTP/ONC) and the HHS … Continue Reading
On June 18, 2025, the U.S. District Court for the Northern District of Texas issued an order in Purl v. United States Department of Health and Human Services, No. 2:24-CV-228-Z (N.D. Tex. 2025) (the June 18 Order) that vacated recent modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule intended … Continue Reading
An Idaho federal court has resolved the tension between that state’s restrictive abortion law and the federal Emergency Medical Treatment & Labor Act (EMTALA) in favor of a hospital system’s obligation to stabilize pregnant patients even if that care includes terminating a pregnancy, at least temporarily.… Continue Reading
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 15, 2025, announcing that it had recovered in excess of $2.9 billion from FCA resolutions during Fiscal Year (FY) 2024 (ending September 30, 2024).… Continue Reading
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently proposed a sweeping rewrite of the HIPAA Security Rule that, if finalized, will require that many Covered Entities and their Business Associates (Regulated Entities) invest significant resources to comply with new, less flexible requirements designed to strengthen the cybersecurity posture … Continue Reading
The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage plans, health care professionals, and third-party marketers, such as agents and brokers. Issued on December 11, 2024, this new Special Fraud Alert focuses on … Continue Reading
The increased use of artificial intelligence (AI) in the banking, insurance, and financial services industries has led the New York State Department of Financial Services (NYDFS or Department) to publish an Industry Letter on October 16, 2024, that highlights cybersecurity risks resulting from the use of AI, the dangers posed by threat actors utilizing AI, … Continue Reading
The healthcare sector has seen an alarming uptick in cybersecurity incidents, including ransomware attacks, in recent years. In response to these cybersecurity threats, New York State is ramping-up efforts to protect patient data by issuing new cybersecurity regulations governing “general hospitals” and by requiring that a healthcare provider spend $2.25 million to improve its internal … Continue Reading
On April 23, 2024, the Federal Trade Commission (FTC), through a 3-2 vote, approved a final rule (the Final Rule), banning most forms of non-compete clauses with workers. A non-compete clause generally prevents a worker from getting a different job or starting a new business that competes with the employer after the conclusion of their … Continue Reading
