Health Care Counsel Blog

Anthem Inc. has agreed to settle a class action lawsuit brought by participants in employee health plans administered by the insurer.

Ambulatory surgery centers (ASCs) have become a large and growing part of the health care industry. ASCs offer same-day surgical care, including diagnostic and preventive procedures, and their popularity has recently grown.

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).

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.

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.

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On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that previously designated hospitals, clinics, and other health care facilities as “protected areas” and limited immigration enforcement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

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.

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.

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.

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

Gender-affirming care (GAC) is a model of care encompassing medical, surgical, mental health, and non-medical services to support transgender and nonbinary individuals in affirming their gender identity. Advocates argue that GAC can be lifesaving for transgender youth experiencing gender dysphoria, a condition characterized by clinically significant distress resulting from incongruence between one’s gender identity and sex assigned at birth. However, recent legislative, executive, and judicial developments at both the federal and state levels have cast uncertainty over the future of GAC for minors.

Headlines that Matter for Companies and Executives in Regulated Industries

In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health Insurance Portability and Accountability Act (HIPAA). The NPRM proposes sweeping changes that impact how health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) implement, document, and maintain safeguards for electronic protected health information (ePHI). OCR is accepting public comments on the NPRM through March 7.

Headlines that Matter for Companies and Executives in Regulated Industries

California is leading the way in ensuring that determinations of medically necessary health care services are made by licensed physicians and not artificial intelligence (AI) algorithms.

Headlines that Matter for Companies and Executives in Regulated Industries

Headlines that Matter for Companies and Executives in Regulated Industries

Now is the time for health care providers to consider participating in the recent Blue Cross Blue Shield (BCBS) antitrust class action settlement and the newly filed antitrust cases alleging widespread price fixing for out-of-network claims by MultiPlan and health insurers.

Headlines that Matter for Companies and Executives in Regulated Industries

On December 30, 2024, the Massachusetts state legislature passed House Bill 4653 (the Act), which significantly enhances regulatory oversight in the Massachusetts health care market. As signed into law by Governor Maura Healy on January 8, the Act will have profound effects for private equity (PE) investors and real estate investment trusts (REITs) engaging with the Massachusetts health care market. Passage of the Act comes on the heels of prominent PE-backed hospital failures in Massachusetts.

On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG).