Insights on Health Care

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).

Partner David Greenberg was quoted on a series of patient lawsuits challenging the alleged use of artificial intelligence (AI) and algorithms by health insurers, commenting on the potential hazards of insurers using the technology.

Health Care Partner Debra Albin-Riley will participate in a session titled “Emerging Medical Staff Trends” at the California Society for Healthcare Attorneys’ (CSHA) 2025 Annual Meeting & Spring Seminar on April 6, 2025.

Headlines that Matter for Companies and Executives in Regulated Industries

This past year, in the wake of significant economic challenges facing the health care industry, an unprecedented number of receiverships were imposed upon skilled nursing facilities in Massachusetts. Historically, Massachusetts receiverships have been used sparingly as a tool to address distressed or insolvent situations, with bankruptcy being the favored option.

The US District Court for the Eastern District of New York in Manalapan Surgery Ctr., et al. v. 1199 SEIU National Benefit Fund, No. 23-CV-03525 (EDNY March 12, 2025), recently granted a motion to dismiss a complaint filed by four out-of-network ambulatory surgery centers against 1199 SEIU National Benefit Fund.

Headlines that Matter for Companies and Executives in Regulated Industries

On March 27, the US Department of Health and Human Services (HHS) announced a significant restructuring initiative in accordance with President Trump’s Executive Order, “Implementing the President’s Department of Government Efficiency Workforce Optimization Initiative.”

In the last year, state activism in healthcare consumer protection has surged, with new laws that heighten oversight of for-profit investors’ engagement with healthcare marketplaces and scrutinize pharmaceutical pricing practices. As part of this activism, several state legislatures have enacted laws regulating use of artificial intelligence (AI) in healthcare delivery.

Headlines that Matter for Companies and Executives in Regulated Industries

A federal court recently rejected arguments by MultiPlan, Inc. and Cigna Health and Life Insurance Company that they had no obligation to ensure payments at the contractually negotiated, in-network rate to Anatomic and Clinical Laboratory Associates, P.C. (ACLA).

Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, as they explore the major shifts occurring in the pharmaceutical industry under the Trump Administration.

On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that previously designated hospitals, clinics, and other health care facilities as “protected areas” and limited immigration enforcement actions in or near such locations.

GPOs seek to promote innovation and cost savings despite large changes in the healthcare supply chain, according to the latest report by industry ethics monitor HGPII.

Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

Headlines that Matter for Companies and Executives in Regulated Industries

On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to agency management or personnel, public property, loans, grants, benefits, or contracts.

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Partners Lowell Brown and Annie Lee and Counsel Sarah Benator will present at The Institute for Medical Leadership’s Chief of Staff Boot Camp in Los Angeles, California.

On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug prices, including Pharmacy Benefit Managers (PBMs), health insurance plans, pharmaceutical manufacturers, and retail pharmacies.

ArentFox Schiff professionals will discuss recent matters that directly impact the life sciences industry and its trajectory.

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication.

On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that prohibited immigration enforcement actions in or near medical and health care facilities and other protected areas. Hospitals and other health care facilities should consider the impact this policy change may have on their workforces and patient populations and develop appropriate protocols for responding to an immigration enforcement action on their premises.

Headlines that Matter for Companies and Executives in Regulated Industries

With 2025 underway, the AFS Health Care team highlights some of the most pressing legal issues facing the health care industry this year.