{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:48:27Z","timestamp":1792072107764,"version":"4.4.0"},"reference-count":59,"publisher":"Cambridge University Press (CUP)","issue":"3","license":[{"start":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:00:00Z","timestamp":1792022400000},"content-version":"unspecified","delay-in-days":287,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2026]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Despite mounting enthusiasm regarding the introduction of artificial intelligence (AI) software as a medical device (SaMD) to clinical care and, consequently, the development of a new regulatory proposal for the federal oversight of AI\/machine learning medical devices, little attention has been paid to the oversight of AI tools used by large insurers. The US Food and Drug Administration (FDA) has advanced an \u201cAction Plan\u201d for clinical AI governance. However, the unregulated application of\n                    <jats:italic>insurance AI<\/jats:italic>\n                    still threatens US healthcare delivery. I use insurance AI tools in the Medicare Advantage (MA) prior authorization pathway as an illustrative case to argue that these technologies require further regulatory attention through interagency collaboration. I identify three agencies at the federal level (i.e., Centers for Medicare &amp; Medicaid Services, Office for Civil Rights, and Office of the National Coordinator for Health Information Technology) which, alongside state-level governance (i.e., through state insurance commissioners), are equipped to expand their regulatory jurisdiction to encompass insurance AI. I advance a framework that harmonizes existing authorities, assigns clear responsibilities, establishes accountability, and creates mechanisms for continuous improvement, respecting agency expertise while ensuring coordination. My aim is to ultimately shift the regulatory paradigm from reactive enforcement to proactive oversight that prevents the deployment of flawed tools in insurance pathways.\n                  <\/jats:p>","DOI":"10.1017\/jme.2026.10269","type":"journal-article","created":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:10:37Z","timestamp":1792069837000},"page":"387-396","source":"Crossref","is-referenced-by-count":0,"title":["Artificial Intelligence in Health Insurance: An Interagency Framework for Federal and State Oversight"],"prefix":"10.1017","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4380-3340","authenticated-orcid":false,"given":"Renee","family":"Sirbu","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/03dbr7087","id-type":"ROR","asserted-by":"publisher"}],"name":"University of Toronto"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,10,15]]},"reference":[{"key":"S1073110526102691_r55","unstructured":"55. \u201cEstate of Gene B. Lokken et al. v. UnitedHealth Group, Inc. et Al.,\u201d Health Care Litigation Tracker, October 28, 2025, https:\/\/litigationtracker.law.georgetown.edu\/litigation\/estate-of-gene-b-lokken-the-et-al-v-unitedhealth-group-inc-et-al\/."},{"key":"S1073110526102691_r22","unstructured":"22. Richard Blumenthal, Sen. , Refusal of Recovery: How Medicare Advantage Insurers Have Denied Patients Access to Post-Acute Care, Majority Staff Report (2024), https:\/\/www.hsgac.senate.gov\/wp-content\/uploads\/2024.10.17-PSI-Majority-Staff-Report-on-Medicare-Advantage.pdf."},{"key":"S1073110526102691_r10","unstructured":"10. Cunningham-Cook, Matthew , \u201cCare Denied: The Dirty Secret Behind Medicare Advantage,\u201d The Lever, June 28, 2023, https:\/\/www.levernews.com\/care-denied-the-dirty-secret-behind-medicare-advantage\/."},{"key":"S1073110526102691_r20","unstructured":"20. Rucker, Patrick et al., \u201cHow Cigna Saves Millions by Having Its Doctors Reject Claims Without Reading Them,\u201d ProPublica, March 25, 2023, https:\/\/www.propublica.org\/article\/cigna-pxdx-medical-health-insurance-rejection-claims."},{"key":"S1073110526102691_r51","unstructured":"51. Health Data, Technology, and Interoperability, 89 Fed. Reg. 1192."},{"key":"S1073110526102691_r29","unstructured":"29. An Act to Accelerate the Discovery, Development, and Delivery of 21st Century Cures, and for Other Purposes, H.R. Res. 34, 114th Cogn. (2016) (enacted)."},{"key":"S1073110526102691_r39","unstructured":"39. Contracts with Medicare+Choice Organizations, 42 U.S.C. \u00a7 1395w-27."},{"key":"S1073110526102691_r31","unstructured":"31. \u201cFrequently Asked Questions Related to Coverage Criteria and Utilization Management Requirements in CMS Final Rule (CMS-4201-F),\u201d Centers for Medicare & Medicaid Services, February 6, 2024."},{"key":"S1073110526102691_r11","unstructured":"11. Lipschutz, David , \u201cNew Research Outlines Extent of Medicare Advantage Overpayments: It\u2019s Much Worse Than We Thought,\u201d Center for Medicare Advocacy, June 22, 2023, https:\/\/medicareadvocacy.org\/ma-overpayments-are-worse-than-we-thought\/."},{"key":"S1073110526102691_r42","unstructured":"42. 42 U.S.C. \u00a7 1395hh."},{"key":"S1073110526102691_r12","unstructured":"12. Abelson, Reed and Sanger-Katz, Margot , \u201c\u2018The Cash Monster Was Insatiable\u2019: How Insurers Exploited Medicare Advantage for Billions,\u201d The New York Times, October 8, 2022, https:\/\/www.nytimes.com\/2022\/10\/08\/upshot\/medicare-advantage-fraud-allegations.html."},{"key":"S1073110526102691_r36","unstructured":"36. Board of Governors of the Federal Reserve System, SR 11-7, Supervisory Guidance on Model Risk Management, (April 4, 2011), ahttps:\/\/www.federalreserve.gov\/frrs\/guidance\/supervisory-guidance-on-model-risk-management.htm."},{"key":"S1073110526102691_r58","unstructured":"58. I would like to thank the reviewer of a much earlier concept of this work for (rightly) bringing this objection to my attention."},{"key":"S1073110526102691_r13","unstructured":"13. Levinson, Daniel R. , Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials , Report in Brief OEI-09-16-00410 (U.S. Department of Health and Human Services, 2018)."},{"key":"S1073110526102691_r34","unstructured":"34. Innovation, Cybersecurity, and Technology (H) Working Group, Use of Artificial Intelligence Systems by Insurers (NAIC, 2023), 9."},{"key":"S1073110526102691_r48","doi-asserted-by":"publisher","DOI":"10.30621\/jbachs.1671119"},{"key":"S1073110526102691_r40","unstructured":"40. Regulations, 42 U.S.C. \u00a7 1395hh."},{"key":"S1073110526102691_r27","unstructured":"27. Levinson, , Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials."},{"key":"S1073110526102691_r5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103311"},{"key":"S1073110526102691_r21","unstructured":"21. Rucker, et al., \u201cHow Cigna Saves Millions by Having Its Doctors Reject Claims Without Reading Them.\u201d"},{"key":"S1073110526102691_r14","unstructured":"14. Ross, Casey and Herman, Bob , \u201cDenied by AI: How Medicare Advantage Plans Use Algorithms to Cut off Care for Seniors in Need,\u201d STAT, March 13, 2023, https:\/\/www.statnews.com\/2023\/03\/13\/medicare-advantage-plans-denial-artificial-intelligence\/."},{"key":"S1073110526102691_r17","unstructured":"17. Casey Ross Herman Bob, \u201cUnitedHealth Pushed Employees to Follow an Algorithm to Cut off Medicare Patients\u2019 Rehab Care,\u201d STAT, November 14, 2023, https:\/\/www.statnews.com\/2023\/11\/14\/unitedhealth-algorithm-medicare-advantage-investigation\/."},{"key":"S1073110526102691_r16","unstructured":"16. Shuren, Jeffrey and Hughes, Dora , \u201cFDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made,\u201d U.S. Food & Drug Administration, FDA, FDA, January 18, 2024, https:\/\/www.fda.gov\/medical-devices\/medical-devices-news-and-events\/fda-and-cms-americans-deserve-accurate-and-reliable-diagnostic-tests-wherever-they-are-made."},{"key":"S1073110526102691_r56","unstructured":"56. Julie Carter, \u201cMedicare Advantage Denials Increased Before the Implementation of New Prior Authorization Rules,\u201d Medicare Rights Center, September 26, 2024, https:\/\/www.medicarerights.org\/medicare-watch\/2024\/09\/26\/medicare-advantage-denials-increased-before-the-implementation-of-new-prior-authorization-rules."},{"key":"S1073110526102691_r3","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2024.00460"},{"key":"S1073110526102691_r41","unstructured":"41. Centers for Medicare & Medicaid Services, \u201cCMS Final Rule (CMS-4201-F) FAQs.\u201d"},{"key":"S1073110526102691_r49","unstructured":"49. Nondiscrimination in Health Programs and Activities, 89 Fed. Reg. 37522."},{"key":"S1073110526102691_r45","unstructured":"45. Levinson, , Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials."},{"key":"S1073110526102691_r25","unstructured":"25. Blumenthal, Refusal of Recovery: How Medicare Advantage Insurers Have Denied Patients Access to Post-Acute Care."},{"key":"S1073110526102691_r35","unstructured":"35. \u201cImplementation of NAIC Model Bulletin: Use of Artificial Intelligence Systems by Insurers,\u201d NAIC, February 1, 2026, https:\/\/content.naic.org\/sites\/default\/files\/cmte-h-big-data-artificial-intelligence-wg-map-ai-model-bulletin.pdf; Meghan O\u2019Connor, \u201cNearly Half of States Have Now Adopted NAIC Model Bulletin on Insurers\u2019 Use of AI,\u201d Quarles, April 2, 2025, https:\/\/www.quarles.com\/newsroom\/publications\/nearly-half-of-states-have-now-adopted-naic-model-bulletin-on-insurers-use-of-ai."},{"key":"S1073110526102691_r38","unstructured":"38. Request for Information and Comment on Financial Institutions\u2019 Use of Artificial Intelligence, Including Machine Learning, 86 Fed. Reg. 16837, https:\/\/www.federalregister.gov\/documents\/2021\/03\/31\/2021-06607\/request-for-information-and-comment-on-financial-institutions-use-of-artificial-intelligence."},{"key":"S1073110526102691_r44","unstructured":"44. Jeannie Fuglesten Biniek et al., \u201cMedicare Advantage Insurers Made Nearly 53 Million Prior Authorization Determinations in 2024,\u201d KFF, January 28, 2026, https:\/\/www.kff.org\/medicare\/medicare-advantage-insurers-made-nearly-53-million-prior-authorization-determinations-in-2024\/."},{"key":"S1073110526102691_r9","unstructured":"9. Agarwal, et al., \u201cComparing Medicare Advantage And Traditional Medicare.\u201d"},{"key":"#cr-split#-S1073110526102691_r37.1","unstructured":"37. Board of Governors of the Federal Reserve System, SR 26-2: Revised Guidance on Model Risk Management (April 17, 2026), https:\/\/www.federalreserve.gov\/supervisionreg\/srletters\/SR2602.htm"},{"key":"#cr-split#-S1073110526102691_r37.2","unstructured":"The original guidance, Supervisory Guidance on Model Risk Management, SR 11-7\/OCC 2011-12 (Apr. 4, 2011), governed banking model risk for 15 years and was extended interpretively to AI and machine learning systems. On April 17, 2026, the Federal Reserve, OCC, and FDIC jointly issued Revised Guidance on Model Risk Management, SR 26-2\/OCC Bulletin 2026-13\/FDIC FIL-15-2026, which supersedes the original guidance while preserving its core structural principles of validation, ongoing monitoring, governance, and effective challenge. The revision adopts a more risk-based approach but does not abandon the architecture that makes the framework analytically useful here."},{"key":"S1073110526102691_r32","unstructured":"32. \u201cContract Year 2024 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4201-P),\u201d Centers for Medicare andMedicaid Services, accessed October 31, 2025, https:\/\/www.cms.gov\/newsroom\/fact-sheets\/contract-year-2024-policy-and-technical-changes-medicare-advantage-and-medicare-prescription-drug."},{"key":"S1073110526102691_r15","unstructured":"15. Ross and Herman, \u201cDenied by AI: How Medicare Advantage Plans Use Algorithms to Cut off Care for Seniors in Need\u201d; Casey Ross and Bob Herman, \u201cHow UnitedHealth\u2019s Acquisition of a Popular Medicare Advantage Algorithm Sparked Internal Dissent over Denied Care,\u201d STAT, July 11, 2023, https:\/\/www.statnews.com\/2023\/07\/11\/medicare-advantage-algorithm-navihealth-unitedhealth-insurance-coverage\/."},{"key":"S1073110526102691_r24","unstructured":"24. Digital Health Law Group, \u201cSenate Investigation Reveals How Medicare Advantage Plans Use Artificial Intelligence to Deny Post-Acute Care,\u201d Digital Healthcare Law, December 17, 2024, https:\/\/digitalhealthcare.law\/2024\/12\/17\/senate-investigation-reveals-how-medicare-advantage-plans-use-artificial-intelligence-to-deny-post-acute-care\/."},{"key":"S1073110526102691_r50","unstructured":"50. Nondiscrimination in Health Programs and Activities, 89 Fed. Reg. 37522."},{"key":"S1073110526102691_r52","unstructured":"52. 42 C.F.R. \u00a7 422 (2025)."},{"key":"S1073110526102691_r57","unstructured":"57. Levinson, , Medicare Advantage Appeal Outcomes and Audit Findings Raise Concerns About Service and Payment Denials."},{"key":"S1073110526102691_r33","unstructured":"33. Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing, 89 Fed. Reg. 1192, https:\/\/www.federalregister.gov\/documents\/2024\/01\/09\/2023-28857\/health-data-technology-and-interoperability-certification-program-updates-algorithm-transparency-and."},{"key":"S1073110526102691_r47","unstructured":"47. Medicare Advantage Program, 42 C.F.R. \u00a7 422 (2025)."},{"key":"S1073110526102691_r2","unstructured":"2. Kaiser Family Foundation, \u201c2024 Employer Health Benefits Survey,\u201d KFF, October 9, 2024, https:\/\/www.kff.org\/health-costs\/2024-employer-health-benefits-survey\/."},{"key":"S1073110526102691_r6","doi-asserted-by":"publisher","DOI":"10.1016\/j.socscimed.2020.113172"},{"key":"S1073110526102691_r43","unstructured":"43. 42 U.S.C. \u00a7 1395hh."},{"key":"S1073110526102691_r30","unstructured":"30. Nondiscrimination in Health Programs and Activities, 89 Fed. Reg. 37522, https:\/\/www.federalregister.gov\/documents\/2024\/05\/06\/2024-08711\/nondiscrimination-in-health-programs-and-activities."},{"key":"S1073110526102691_r7","unstructured":"7. FDA, Artificial Intelligence\/Machine Learning (AI\/ML)-Based Software as a Medical Device (SaMD) Action Plan (FDA, 2021), https:\/\/www.fda.gov\/medical-devices\/software-medical-device-samd\/artificial-intelligence-and-machine-learning-software-medical-device."},{"key":"S1073110526102691_r4","article-title":"The National Physician Shortage: Disconcerting HRSA and AAMC Reports","author":"Adashi","journal-title":"Journal of General Internal Medicine"},{"key":"S1073110526102691_r19","unstructured":"19. Ross and Herman, \u201cDenied by AI: How Medicare Advantage Plans Use Algorithms to Cut off Care for Seniors in Need.\u201d"},{"key":"S1073110526102691_r8","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2020.02149"},{"key":"S1073110526102691_r23","unstructured":"23. Blumenthal, Refusal of Recovery: How Medicare Advantage Insurers Have Denied Patients Access to Post-Acute Care."},{"key":"S1073110526102691_r26","unstructured":"26. \u201cSenate Permanent Subcommittee on Investigations Releases Majority Staff Report Exposing Medicare Advantage Insurers\u2019 Refusal of Care for Vulnerable Seniors,\u201d U.S. Senator Richard Blumenthal of Connecticut, October 17, 2024, https:\/\/www.blumenthal.senate.gov\/newsroom\/press\/release\/senate-permanent-subcommittee-on-investigations-releases-majority-staff-report-exposing-medicare-advantage-insurers-refusal-of-care-for-vulnerable-seniors."},{"key":"S1073110526102691_r18","unstructured":"18. Herman, \u201cUnitedHealth Pushed Employees to Follow an Algorithm to Cut off Medicare Patients\u2019 Rehab Care.\u201d"},{"key":"S1073110526102691_r46","unstructured":"46. Contracts with Medicare+Choice Organizations, 42 U.S.C. \u00a7 1395w-27."},{"key":"S1073110526102691_r54","unstructured":"54. Center for Devices and Radiological Health, \u201cDivision of Partnerships and Innovation,\u201d FDA, January 24, 2025, https:\/\/www.fda.gov\/about-fda\/center-devices-and-radiological-health\/division-partnerships-and-innovation."},{"key":"S1073110526102691_r28","unstructured":"28. U.S. Department of Health and Human Services, Office of the Commissioner, \u201cClassification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry and FDA Staff,\u201d FDA, September 2017, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/classification-products-drugs-and-devices-and-additional-product-classification-issues."},{"key":"S1073110526102691_r53","unstructured":"53. Blumenthal, , Refusal of Recovery: How Medicare Advantage Insurers Have Denied Patients Access to Post-Acute Care."},{"key":"S1073110526102691_r1","first-page":"23","article-title":"Population Bulletin","volume":"70","author":"Mather","year":"2015","journal-title":"Population Reference Bureau"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110526102691","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:13:07Z","timestamp":1792069987000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110526102691\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026]]},"references-count":59,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026]]}},"alternative-id":["S1073110526102691"],"URL":"https:\/\/doi.org\/10.1017\/jme.2026.10269","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026]]}}}