Health Care Law Today

The Massachusetts Health Policy Commission, an independent state agency that works to improve affordability of health care for residents of the Commonwealth, released Advance Guidance for “Providers” and “Provider Organizations” considering transactions subject to the HPC’s updated Notice of Material Change process.

The U.S. Department of Health and Human Services and the Drug Enforcement Administration have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine to December 31, 2025.

On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act, which closes perceived “legal loopholes” in social media advertisements by telehealth companies.

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op., 2025 WL 746028, at *15  (N.D. Tex. Mar. 5, 2025), denying plaintiffs’ motion for (1) a preliminary injunction (PI) prohibiting the FDA from taking action against Outsourcing Facilities Association (OFA) members and FarmaKeio based on their compounding of the drug ingredient tirzepatide pending final judgment in the case and (2) a stay pending conclusion of the review proceedings in response to the FDA’s declaration that the shortage of the diabetes and weight-loss tirzepatide products has been resolved.  

GLP-1 receptor agonists were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health conditions.

On March 5, 2025, two Senators and one Representative introduced SB 25-198, designed to enhance transparency in transactions involving health care entities.

In the evolving health care landscape, mergers between nonprofit health care organizations are becoming increasingly common.

On February 21, 2025, California introduced AB 1415, a bill aimed at expanding the regulatory oversight of the Office of Health Care Affordability.

PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was hosted by Foley partner, Jana Kolarik, and PYA consulting principal, Angie Caldwell. Here are the key takeaways from each session.