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 ›

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 ›

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 ›

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 ›

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 ›

The U.S. Food and Drug Administration recently issued its first-ever draft guidance on the use of AI for the development of drug and biological products.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 ›

The Department of Health and Human Services (HHS) released its AI Strategic Plan in January 2025, establishing a comprehensive approach to artificial intelligence. The Plan’s Overview states that it “provides a framework and roadmap to ensure that HHS fulfills its... Read More ›

New legislation in California regulates communications by health care providers who use artificial intelligence in communications with patients.   Specifically, an addition to the state’s Health and Safety Code entitled “Artificial Intelligence in Health Care Services” requires a disclaimer that... Read More ›

Medicare Advantage insurers are using prior authorization requirements to systematically deny seniors access to post-acute care facilities, according to a recent U.S. Senate investigative report. Dated October 17, 2024, the Majority staff report of the Senate Permanent Subcommittee on Investigations... Read More ›

Earlier this year on September 20, 2024, Plaintiffs filed their Opposition papers to Cigna Corporation’s and Cigna Health and Life Insurance Company’s (collectively, “Cigna”) motion to dismiss their lawsuit challenging Cigna’s use of an AI algorithm to allegedly automatically deny... Read More ›

New regulations requiring Medicare Advantage (MA) organizations to ensure non-discriminatory use of artificial intelligence and automated systems have been proposed by the Centers for Medicare & Medicaid Services (CMS). These AI provisions are part of a broader proposed rule titled... Read More ›

On July 15, 2024, UnitedHealth Group (“UHG”) and its co-defendants filed a reply brief supporting their motion to dismiss a class action lawsuit alleging improper use of artificial intelligence to deny Medicare Advantage claims. Filed in the United States District... Read More ›