Author Archives
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New Peterson-KFF Report Analyzes Impact of Cost on Healthcare Access
A new report from the Peterson Center on Healthcare and KFF, titled “How does cost affect access to healthcare?” explores the significant financial barriers many Americans face when trying to access medical care. Published on April 7, 2025, the analysis… Read More ›
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Health Tech Investment Act Introduced to Create Medicare Payment Pathway for AI Devices
On April 9, 2025, the Health Tech Investment Act was introduced in the Senate, seeking to encourage the use of “cutting-edge” artificial intelligence (AI)-enabled medical devices by ensuring appropriate payment for the use of such devices under the Medicare program…. Read More ›
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New CMS Hospital Transparency Rule Guidance: Hospitals Must Report Actual Dollar Amounts, Discontinue “Nine 9s”
On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) announced updated guidance (“guidance”) concerning the Hospital Price Transparency Rule, which requires hospitals operating in the U.S. to publish a list of standard charges for items and services… Read More ›
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ONC Prepares Final USCDI Version 6, Focusing on Interoperability for Patient Care
The Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) is currently working to finalize Version 6 of the standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange,… Read More ›
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Federal Health Agencies Seek Public Input to Modernize Digital Health for Medicare Beneficiaries
WHAT: Request for Information on Digital Health Products On May 16, 2025, federal health agencies published a request for information (RFI) that “seeks input from the public regarding the market of digital health products for Medicare beneficiaries as well as… Read More ›
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Court Partially Grants, Partially Denies Cigna’s Motion to Dismiss AI Claims Review Case
The U.S. District Court for the Eastern District of California, in an order filed March 31, 2025, issued a mixed ruling on Cigna’s motion to dismiss the PxDx algorithm-focused putative class action (Kisting-Leung, et al. v. Cigna Corporation, et al.),… Read More ›
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CMS Finalizes Key Prior Authorization Changes for Medicare Advantage in 2026 Rule
The Centers for Medicare & Medicaid Services (CMS) finalized important updates impacting prior authorization of care processes within the Medicare Advantage (MA) program. These changes, detailed in the CMS 2026 Medicare Advantage Final Rule (“Rule”), aim to enhance beneficiary protections… Read More ›
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CMS Finalizes 2026 MA Rule, Omits Proposed AI Guardrails Despite Earlier Concerns
On April 7, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Rate Announcement and final rule for Medicare Advantage (MA) and Part D programs. Notably absent from this final regulation were specific guardrails… Read More ›
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Federal Court Allows UnitedHealthcare AI Coverage Denial Case to Proceed on Contract Claims
On February 13, 2025, a federal court dismissed several state law claims against UnitedHealthcare but allowed breach of contract and good faith claims to proceed in a case alleging improper use of AI to deny medical coverage. More specifically, the… Read More ›
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Artificial Intelligence in Medical Devices: FDA Releases Draft Guidance for Lifecycle Management and Marketing
The U.S. Food and Drug Administration recently issued its first-ever draft guidance on the use of AI for the development of drug and biological products. Entitled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” it serves as… Read More ›