On April 1, the U.S. Food and Drug Administration (FDA) clarified its policies on compounded drugs, including compounded versions of GLP-1 products. Compounders are permitted to produce copies of approved drugs only while those drugs are listed in FDA’s ​shortage database.

GLP-1 products are used primarily for weight loss and diabetes. They include semaglutide (used…

A recent report issued by The NYU Stern Center for Center for Business and Human Rights entitled “Private Equity and Healthcare: Balancing Profit with Wellness” examined the expanding role of private equity in the healthcare sector, concluding that “Private Equity’s combination of legal immunity, public anonymity, and financialized ownership creates a culture that often prioritizes…

On March 26, the U.S. Department of Justice (DOJ) and the U.S. Attorney’s Office for the Southern District of New York filed a civil antitrust lawsuit against The New York and Presbyterian Hospital (NYP). The Complaint alleges that NYP violated Section 1 of the Sherman Act by requiring restrictive anti-competitive language in its commercial contracts…

Last month, Pinnacle MultiCare Nursing and Rehabilitation Center (Pinnacle) filed a federal action to stop the U.S. Department of Health and Human Services (HHS) from recouping tens of millions of dollars in Medicare Part A payments made to Pinnacle during the COVID-19 pandemic. According to its Complaint, Pinnacle received a letter from…

On March 20, the Federal Trade Commission (FTC) issued a memorandum announcing the formation of a Healthcare Task Force dedicated to addressing unlawful business practices within the healthcare sector. The memorandum emphasizes that industry consolidation and anticompetitive conduct have contributed to “higher prices, decreased quality, less access and transparency, and stifled innovation.” According to the FTC…

On February 6, Rhode Island introduced legislation that would significantly expand its corporate practice of medicine (CPOM) restrictions and impose new healthcare ownership transparency requirements. The proposal would prohibit unlicensed entities from owning medical practices or employing licensed providers, while requiring physicians to hold majority ownership and control. It also targets MSO arrangements by banning…

In a March 3 letter addressed to Gov. Kathy Hochul, CMS Administrator Dr. Mehmet Oz raised pointed concerns about fraud, waste and abuse (“FWA”) within New York’s Medicaid Program involving payments for home health-related services. 

In his letter, Dr. Oz states:

Recent public reporting, federal prosecutions, and CMS analyses raise serious concerns about New York’s…

New York Gov. Kathy Hochul recently signed a new law that will allow registered dental hygienists in the state to practice without the direct supervision of a dentist by mid-2027, pursuant to collaborative agreements with dentists. The legislation broadens permissible practice settings to include foster care agencies, signaling a path toward a semi-independent business model…

A STAT News article, “How a Texas Couple is Getting Rich Off Out-of-Network Medical Bills,” explores how entrepreneurs Scott and Alla LaRoque built profitable businesses like MPOWERHealth, an intraoperative neuromonitoring company, by finding ways to exploit the 2020 No Surprises Act—a law intended to protect patients from unexpected medical bills by out-of-network providers.

When does marketing cross the line? Learn from recent cases and enforcement trends reshaping anti-kickback risk for companies and counsel. On April 2, from 2:00 PM to 3:00 PM, Rivkin Radler’s Jeff Kaiser will speak on the ABA Litigation Section webinar, “Marketing or Misconduct? Trends and Hot Topics on Anti-Kickback Enforcement.” To register, click here