The State of AI Regulation in Healthcare: Still Complicated
By Lee G. PetroMember
Dickinson Wright PLLC
As artificial intelligence (AI)‑driven tools proliferate across clinical care, diagnostics, and health insurance operations, the U.S. regulatory landscape is shifting rapidly in 2026. Absent a comprehensive federal AI statute, healthcare organizations face a patchwork of federal oversight (primarily through the FDA, CMS, and HHS) layered with a growing number of state AI health laws.
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Provider Based Attestation Compliance Needs
By Marisol Cooke,
Director, Health Care Consulting Practice, Baker Tilly
By Brian Restivo,
Director, Health Care Consulting Practice, Baker Tilly
Provider-based attestation compliance for off-campus hospital outpatient departments (HOPD) remains a high-risk Medicare issue for hospitals, particularly for off-campus clinics and recently acquired physician practices.
Provider-based status allows hospitals to bill under the Hospital Outpatient Prospective Payment System (OPPS) at more favorable rates designed to cover higher hospital overhead, and allow the ability to utilize the 340B drug program at these locations. The Consolidated Appropriations Act of 2026 formally requires attestation of compliance with complex regulations and significantly penalizes noncompliance.
Hospitals need to start preparing a compliance framework to review their provider-based compliance and to outline how it will meet the new attestation requirements. The underlying regulations that need to be reviewed under 42 CFR § 413.65 are not changing, so hospitals shouldn’t wait until Centers for Medicare & Medicaid Services (CMS) issues new implementation instructions to start their review.
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