United States: Healthcare

For years, long-term care providers have navigated the delicate balance between respecting resident privacy, accommodating family oversight, honoring roommate privacy, and maintaining smooth facility operations.

The US Department of Labor has proposed a new electronic disclosure safe harbor specifically for ERISA-covered group health plans, potentially transforming how plan administrators deliver required disclosures to participants. This proposed framework would mirror the 2020 retirement plan e-disclosure safe harbor by enabling default electronic delivery through a notice-and-access model, moving away from the outdated 2002 consent-based standard. The DOL projects this change could raise electronic delivery rate

The U.S. Department of Labor's Employee Benefits Security Administration has issued a proposed electronic disclosure rule that would modernize how ERISA-governed group health plans deliver required documents to participants.

FDA has published revised draft guidance clarifying how sponsors can demonstrate substantial evidence of effectiveness for drug and biologic approvals, emphasizing a totality-of-evidence approach that may allow reliance on a single rigorous clinical trial with confirmatory evidence. The guidance reframes regulatory flexibility as a principle-based tool while expanding acceptance of alternative statistical approaches and real-world evidence, though it stops short of establishing a formal single-trial default

CVS Health subsidiary Caremark has reached a landmark settlement with the Federal Trade Commission, requiring sweeping changes to its pharmacy benefit management practices including rebate transparency, formulary prioritization of lower-cost drugs, and point-of-sale rebate programs. The agreement follows a similar Express Scripts settlement and could fundamentally reshape how the nation's largest PBMs operate, potentially delivering billions in consumer savings while accelerating an industry-wide shift from

Recent UPC decisions in Promosome v BioNTech and Gilead v AMMS clarify critical aspects of patent validity practice, including enablement requirements for novelty, the framework for assessing inventive step...

Hospital and health system leaders are shifting from isolated transactions to comprehensive strategic planning that integrates partnerships, acquisitions, technology investments, and alternative capital structures. As market pressures intensify and care delivery models evolve, organizations must balance growth against financial constraints while building the right portfolio of partnerships and implementing AI-driven solutions to achieve long-term sustainability.

Massachusetts Governor Maura Healey has proposed regulations that would prohibit licensed medical care providers and debt collectors from reporting medical debt to consumer credit agencies. The proposal aims to protect patients from long-term financial harm following unexpected medical emergencies, with non-compliant providers potentially losing their licenses. This move follows similar actions in at least 17 other states, though some state laws face legal challenges based on federal preemption arguments.

Accord BioPharma has secured FDA approval for ENNUMO, its second pegfilgrastim biosimilar referencing Amgen's NEULASTA, positioning the company as the only U.S. provider offering two distinct pegfilgrastim biosimilars alongside a short-acting G-CSF biosimilar. With eight pegfilgrastim biosimilars now approved by the FDA, the competitive landscape for these infection-reducing cancer treatments continues to expand. This approval strengthens Accord's biosimilar portfolio in the oncology supportive care market.