rstand practical implications. As UM/PA itself has been subject to increased regulatory and media scrutiny over the past couple of years, collaboration can also foster the development of best practices for the ethical and effective use of AI in UM/PA. This is a new regulatory and technological landscape, and regulators are still catching up. In the meantime, stakeholders should be committed to setting strong industry standards to build greater trust and reliability in their platforms.ConclusionThe regulatory environment surrounding the use of AI in healthcare, particularly in UM/PA, is rapidly evolving. Insurers must remain vigilant and adaptable, ensuring that their AI applications and processes for conducting UM/PA are compliant with the latest regulations. Holland & Knight's Healthcare & Life Sciences Team will continue to monitor for any new federal and state initiatives governing the use of AI in UM/PA – and more generally within the healthcare sector.Notes E.O., Sec. 8(b)(i)(A). 88 Fed. Reg. 22120, 22195 (April 12, 2023). 89 Fed. Reg. 8758 et seq.

Protection Bureau, Department of Education, Department of Homeland Security, Department of Health and Human Services, and Equal Employment Opportunity Commission, JOINT STATEMENT ON ENFORCEMENT OF CIVIL RIGHTS, FAIR COMPETITION, CONSUMER PROTECTION, AND EQUAL OPPORTUNITY LAWS IN AUTOMATED SYSTEMS, April 4, 2024; Federal Trade Commission, Privacy and Data Security Update, 2023.[xiv] 21 U.S.C. § 360j(o)(1)(E).[xv] U.S. Food and Drug Administration, Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together, March 15, 2024; Clinical Decision Support Software, September 28, 2022.[xvi] U.S. Food and Drug Administration, Clinical Decision Support Software, September 28, 2022, pp. 4-6.[xvii] Office of the National Coordinator for Health Information Technology, Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule, 89 FR 1192, March 11, 2024.[xviii] CMS Final Rule (CMS-4201-F), 88 Fed. Reg. 22120, April 12, 2023; Frequently Asked Questions related to Coverage Criteria and Utilization Management Requirements in CMS Final Rule (CMS-4201-F), February 6, 2024.[xix]Utah S.B. 149 “Artificial Intelligence Amendments”; The Artificial Intelligence Policy Act defines generative AI as “an artificial system that: (i) is trained on data; (ii) interacts with a person using text, audio, or visual communication; and (iii) generates non-scripted outputs similar to outputs created by a human, with limited or no human oversight.”[xx] Colorado Artificial Intelligence Act, S.B. 24-205; The Colorado Artificial Intelligence Act defines algorithmic discrimination as “any condition in which the use of an artificial intelligence system results in an unlawful differential treatment or impact that disfavors an individual or group of individuals on the basis of their actual or perceived age, color, disability, ethnicity, genetic information, limited proficiency in the English language, national origin, ra

ed to opine on their stance regarding managed-care plans use of these tools in utilization management for further restrictions to apply in the Medicaid space. President Joe Biden. Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. October 30, 2023. https://www.whitehouse.gov/briefing-room/presidential-actions/2023/10/30/executive-order-on-the-safe-secure-and-trustworthy-development-and-use-of-artificial-intelligence/ HPMS are delivered directly to MA plans and publicly posted at the end of the week on CMS’ website. The memo can be found here https://www.aha.org/system/files/media/file/2024/02/faqs-related-to-coverage-criteria-and-utilization-management-requirements-in-cms-final-rule-cms-4201-f.pdf. Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, was published in 88 FR 22120 and is available at https://www.federalregister.gov/documents/2023/04/12/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program. See FAQ 4 and 5 of the HPMS memo for descriptions of criteria standards that are based on current evidence in widely use treatment guidelines or clinical literature and clinical benefits that are highly likely to outweigh any clinical harm.

e clinical coverage determinations, the FAQs indicate that plans can use AI and other software tools for a wide range of activities, including determining compliance with coverage criteria, facilitating coverage approvals, identifying alternative treatments and levels of care, and studying the effectiveness of interventions, all of which could ultimately bring significant benefits for enrollees, providers and plans.The bottom line is plans can leverage AI as a tool to facilitate coverage decisions but cannot fully delegate the process to AI.1 The FAQs are available at https://www.aha.org/system/files/media/file/2024/02/faqs-related-to-coverage-criteria-and-utilization-management-requirements-in-cms-final-rule-cms-4201-f.pdf. The final rule, titled Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, was published in 88 FR 22120 and is available at https://www.federalregister.gov/documents/2023/04/12/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program.2 The Biden Administration’s regulations implementing the Section 1557 prohibitions on discrimination in the context of clinical algorithms remain pending. https://www.federalregister.gov/d/2022-16217/p-1615

orter audits, which could risk quicker adverse findings. Accordingly, vetting current compliance infrastructure around the issues in OIG's strategic plan, developing an audit readiness checklist, evaluating documentation availability, and advising key stakeholders of OIG's latest focus areas may at least smooth the path for those managed care plans whose contracts OIG selects for review. And this new spate of audits may be an instructive foreshadowing to government contractors outside of managed care.[] See Federal News Network, The Health and Human Services inspector general takes on a $400B program, Sept. 19, 2023, available at https://federalnewsnetwork.com/agency-oversight/2023/09/the-health-and-human-services-inspector-general-takes-on-a-400b-program/.[2] See Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly, 88 Fed. Reg. 22120 (pub. Apr. 12, 2023; eff. June 5, 2023).[3] See Kerry Dooley Young, Prior Authorization Reform Bill Advances in Congress, but Conflict Looms, Medscape (Aug. 3, 2023), available at https://www.medscape.com/viewarticle/995133.