Articles and Blogs

Historically, health care entities looking to avoid potential violations under the Federal Stark Law (“Stark”) have not turned to the Payments by a Physician exception at 42 C.F.R. § 411.357(i) to protect their operations. A review of the exception’s history, however, combined with recent experience with pending submissions to the Centers for Medicare & Medicaid…Read More

Health care continues to drive private equity (“PE”) activity, creating opportunities for investors and traditional health care providers. Transactions in the health care space are especially complicated, layering health care regulatory and reimbursement considerations on top of a complex securities, antitrust, privacy and security framework. Hall Render’s PE team of attorneys and advisors leverage the…Read More

The Indiana General Assembly recently passed Senate Enrolled Act No. 475 (“SEA 475”), which will ban new noncompete agreements between physicians and covered health care entities entered into on or after July 1, 2025. Governor Braun is expected to sign the bill. As explained further below, the noncompete ban applies to hospitals, hospital systems, parent…Read More

Within weeks of taking office in his second term, President Trump issued a series of executive orders aimed at diversity, equity and inclusion (“DEI”) initiatives. The orders sought to eliminate “illegal preferences, mandates, policies, programs, activities, guidance, regulations, enforcement actions, consent orders and requirements.” The executive orders repeatedly use the phrase “illegal DEI” but do…Read More

On March 31, 2025, the U.S. District Court for the Eastern District of Texas (District Court) struck down the U.S. Food and Drug Administration’s (“FDA” or “Agency”) Final Rule that would have asserted FDA’s authority to regulate laboratory-developed tests (“LDTs”) as medical devices under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) (“LDT Final…Read More

New York’s regulatory oversight of health care transactions is evolving rapidly. The Disclosure of Material Transactions Law (Article 45-A of the Public Health Law), which took effect August 1, 2023, introduced new pre-closing reporting obligations for health care entities. Now, Governor Kathy Hochul’s proposed amendments—introduced in her January 21, 2025 executive budget—aim to significantly expand…Read More

Three recent cases out of New York show the value in obtaining Advisory Opinions from the Office of Inspector General (“OIG”) when considering the risk of certain arrangements under the Anti-Kickback Statute (“AKS”). Background In 2022, a whistleblower who was also a physician (“Relator”) filed a False Claims Act Complaint against Platform, an online platform…Read More

On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit (the “Court”) reversed the conviction of Mark Sorensen under the federal Anti-Kickback Statute (“AKS”), holding that payments to marketing firms and manufacturers – absent influence over health care decisions – do not constitute illegal kickbacks. Notably, this marks the Seventh Circuit’s first…Read More