Articles and Blogs

Recently, the Departments of Health and Human Services, Labor and the Treasury (collectively, the “Departments”) issued an extension for health care providers impacted by the Change Healthcare cyberattack to submit out-of-network payment disputes through the federal No Surprises Act (“NSA”) independent dispute resolution (“IDR”) process. The NSA IDR process permits providers and facilities that are…Read More

In April 2024, the U.S. Food and Drug Administration (“FDA”) issued revised draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” (the “Draft Guidance”) intended to address common questions that arise during the process of developing promotional communications for prescription reference products and…Read More

A recent report indicated that the U.S. ambulatory services market is expected to reach $417B by 2030, expanding by 5.4% per year. Primary care offices will remain the largest share of that market (48%), but the surgical specialty segment is expected to grow at the fastest rate. Senior living development is expected to see a…Read More

On June 28, 2024, the Supreme Court of the United States overturned a long-standing doctrine, known as Chevron deference, that impacts a court’s deference to a government agency’s action during administrative proceedings. The Supreme Court held that federal courts cannot defer to agencies’ interpretations of statutes. Instead, courts must independently make this determination. Background The Supreme Court…Read More

Massachusetts is the latest state to propose legislation to restrict health care private equity transactions. The bill covers traditional corporate transactions and hospital sale-leasebacks with real estate investment trusts (“REITs”). The legislation was proposed in light of the Steward Health Care bankruptcy. Steward has eight hospitals in Massachusetts that are leased from Medical Properties Trust….Read More

On Thursday, June 20, 2024, the United States District Court for the Northern District of Texas (“the Court”) issued a ruling in a case that could have significant implications for enforcement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The case, which was brought by the American Hospital Association (“AHA”), the Texas…Read More

After sweeping updates to Indiana’s emergency detention and involuntary commitment laws last year, the General Assembly made additional updates in 2024 in House Enrolled Act No. 1216. These changes begin impacting how providers apply for emergency detentions on July 1, 2024. Background Last year, Indiana rewrote its emergency detention laws to provide more treatment with…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

In May 2024, the U.S. Food and Drug Administration (“FDA”) issued a Final Guidance titled “Remanufacturing of Medical Devices,” clarifying the definition of “remanufacturing” for reusable medical devices in need of maintenance or repair (“Final Guidance”). According to the FDA, the Final Guidance is designed to help medical device servicers understand when certain device repairs…Read More