Health Care Counsel Blog
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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On January 20, the US Department of Homeland Security (DHS) rescinded 2021 guidelines that prohibited immigration enforcement actions in or near medical and health care facilities and other protected areas.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.
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
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).
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. Enforcement will begin against the backdrop of a pending lawsuit challenging the validity of the new protections and an incoming Trump Administration with an uncertain enforcement posture.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
This past July, we reported on the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS) rules. CMS has now released the 2025 final rules, though they will not be published in the Federal Register for several more weeks.
Headlines that Matter for Companies and Executives in Regulated Industries
Headlines that Matter for Companies and Executives in Regulated Industries
On October 28, the US Court of Appeals for the Fifth Circuit held that a nonprofit corporation that coordinates health care for privately insured patients does not qualify for tax exemption under Section 501(c)(4) because it is not “operating exclusively for the promotion of social welfare.”