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New California law to regulate automated claims processing using modern technology, like AI
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 artifi...
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...
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 ...
OIG Issues Unfavorable Opinion on Medicare Advantage Gainsharing Arrangements
The Office of Inspector General of the Department of Health and Human Services (OIG) has published an unfavorable advisory opinion involving a proposal by a Medicare Advantage Organization (MAO) ...
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...
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...
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 rese...
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 w...
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 ...
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 “disinc...