[05/02/25]
Posted on May 2, 2025 in Health Law News
Published by: Hall Render
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 &... READ MORE
Tags: CMS Regulations, Physician Compensation, Self-Referral Disclosure Protocol, Stark law, Timeshare Arrangements
[05/01/25]
Posted on May 1, 2025 in Health Law News, Private Equity
Published by: Hall Render
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... READ MORE
Tags: PRIVATE EQUITY, Private Equity Deal Spotlight
[04/29/25]
Posted on April 29, 2025 in Health Law News
Published by: Hall Render
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,... READ MORE
Tags: Hall Render Insights, Legislative Updates, Noncompete Agreements, Physician Employment Agreements, sea 475
[04/29/25]
Posted on April 29, 2025 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: DEI Compliance, Executive Orders, False Claims Act, Government Investigations, Labor and Employment
[04/28/25]
Posted on April 28, 2025 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: FDA regulations, LDT, Medical Devices
[04/28/25]
Posted on April 28, 2025 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: Compliance and Oversight, Health Care Law, Health Care Transactions, New York Health Care Regulation, Private Equity in Health Care
[04/28/25]
Posted on April 28, 2025 in Health Law News
Published by: Hall Render
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... READ MORE
Tags: Advisory Opinion Process, Anti-Kickback Statute, Office of Inspector General, oig
[04/28/25]
Posted on April 28, 2025 in Litigation Analysis
Published by: Hall Render
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... READ MORE
Tags: Anti-Kickback Statute, United States v. Sorensen
[04/25/25]
Posted on April 25, 2025 in Health Law News, Health Provider News
Published by: Hall Render
NATIONAL 100 rural hospitals have closed labor and delivery in 5 years: Report 4 Joint Commission moves AHA backs bill revising reimbursement for long-term care Attorneys general to Congress: Ban PBMs from owning pharmacies DOGE stalls healthcare payments: 6 things to know Federal agency warns of potential breach in Oracle’s legacy cloud system Forget... READ MORE
[04/25/25]
Posted on April 25, 2025 in Health Law News, Hospital Real Estate Briefing
Published by: Hall Render
VMG published its 2025 Health Care M&A Report. Key takeaways: 1) Health systems are focused on portfolio optimization and improving operating margins; 2) the use of AI is a key strategy being employed by health systems to improve financial performance; and 3) health systems are creating joint ventures with ancillary providers (outpatient, behavioral health... READ MORE
Tags: Health Care Real Estate, Health Care Real Estate Briefing, Hospital Real Estate Briefing