California’s new law, SB 1120, set to take effect on January 1, 2025, regulates how health care service plans (HCSPs) and disability insurers use automated decision-making tools, such as artificial intelligence, to analyze medical necessity in utilization reviews affecting
Latest from Health Industry Washington Watch - Page 6
CMS Ramps up Process for Identifying Private-Equity Ownership of SNFs
This month, the Centers for Medicare & Medicaid Services (CMS) has begun an off-cycle revalidation process directed at all Medicare-participating skilled nursing facilities (SNFs). The process is designed to implement provisions of the Affordable Care Act (ACA) that require facilities
Are False Claims Act Whistleblower Cases Unconstitutional?
Are the qui tam provisions of the False Claims Act an unconstitutional delegation of authority to private citizens? One federal court, accepting an invitation from a Supreme Court dissent, ruled the answer is yes.
In an opinion issued yesterday dismissing
Private organizations benefit from HHS plan for state and local governmental AI use
The U.S. Department of Health and Human Services (HHS) has published its Plan for Promoting Responsible Use of Artificial Intelligence in Automated and Algorithmic Systems by State, Local, Tribal, and Territorial Governments in the Administration of Public Benefits (AI Plan
HHS OIG won’t enforce antifraud statutes against patient assistance program
The Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a favorable advisory opinion regarding whether a proposed patient assistance program (“PAP”) would run afoul of Federal antifraud statutes.
Under the proposed PAP, a nonprofit organization
Artificial Intelligence raises important legal and policy considerations for patient data and clinical trials
The use of artificial intelligence (AI) in research and development and the research and development of AI solutions themselves create far reaching legal and policy questions in the clinical research context.
In one of the latest installments of Reed Smith’s
OIG Issues Opinions On Arrangements Involving Gene Therapy Treatments
The Department of Health and Human Services Office of Inspector General (OIG) recently issued two advisory opinions related to proposed arrangements offering financial assistance to individuals who receive gene therapy treatments. These arrangements were specifically targeted to patients who may
CMS Revisits Medicare Overpayment Standards in 2025 Physician Fee Schedule
In its recently released 2025 proposed Medicare Physician Fee Schedule (“MPFS”), the Centers for Medicare & Medicaid Services (“CMS”) proposed two important modifications to the Medicare 60-day overpayment refund rule—a new “identified overpayment” standard and codification of a 6-month timeframe
HHS Finalizes Rule on Health Care Provider Information Blocking Penalties
The Centers for Medicare & Medicaid Services (“CMS”) and the Office of the National Coordinator for Health Information Technology (“ONC”) have released a final rule establishing “disincentives” (i.e., penalties) for health care providers that participate in certain Medicare payment programs
Reed Smith Provides Analysis of Chevron’s End and Its Impact on Regulated Industries
The fallout from last week’s Loper Bright/Relentless opinion by the U.S. Supreme Court that prospectively eliminated Chevron deference is still not fully clear, but Reed Smith has put together a Chevron Deference Resource Center where we will gather perspectives and