The increasing use of artificial intelligence and advanced technology in health care is setting into motion a wave of lawsuits that attorneys expect to grow in the months ahead.<\/p>\n
Insurers The litigation comes amid increasing efforts from Congress and the Biden administration to develop a legal framework around the quickly expanding role of artificial intelligence in health care.<\/p>\n \u201cAI is finding its way into every aspect of our lives. And regulators and legislators are trying to keep up with it, but not doing a great job of that,\u201d said Ryan Clarkson, founder of Clarkson Law Firm, the public interest firm behind the suits against insurers.<\/p>\n Two of Clarkson\u2019s lawsuits focus on technology used to make coverage decisions for beneficiaries in Medicare managed care plans.<\/p>\n These private Medicare Advantage plans are under scrutiny from lawmakers, regulators, and patients for using advanced approval\u2014or \u201cprior authorization\u201d\u2014to deny coverage that\u2019s typically granted in fee-for-service Medicare. More than 30 House Democrats say the problem may have worsened<\/a> with the plans\u2019 increasing use of \u201cAI or algorithmic software managed by firms\u201d like naviHealth<\/a> and CareCentrix<\/a> \u201cto assist in their coverage determinations.\u201d<\/p>\n These AI-powered tools analyze data that helps insurers make coverage decisions. Insurers \u201chave to\u201d use advanced technology, said Michael Levinson, a Berger Singerman LLP partner who is also a licensed physician. \u201cThe volume of claims is tremendous.\u201d<\/p>\n Eric Hausman, a spokesman for UnitedHealth Group, said in an e-mail response that the company\u2019s \u201cnaviHealth predict tool\u201d isn\u2019t used to make coverage determinations.<\/p>\n Coverage decisions are based on the terms of a member\u2019s plan and coverage criteria from the Centers for Medicare & Medicaid Services, Hausman said.<\/p>\n \u201cAdverse coverage decisions are made by physician medical directors and are consistent with Medicare coverage criteria for Medical Advantage Plans,\u201d Hausman said. \u201cThis lawsuit has no merit, and we will defend ourselves vigorously.\u201d<\/p>\n Clarkson has spoken with dozens of Medicare Advantage policyholders, whistleblowers, nonprofits, and public interest lawyers. All of them, he said, tell a similar story: Insurers are using AI and algorithms \u201cto try and improve their bottom line under the guise of delivering better service to their policyholders.\u201d<\/p>\n The firm has identified at least three additional insurers using advanced technology to prematurely deny claims, said Glenn Danas, a partner at Clarkson Law.<\/p>\n He also noted that doctors, diagnostic companies, and others have reached out about improper technology use, as they\u2019re \u201cvery frustrated that they\u2019re not able to deliver the sort of care they want to.\u201d<\/p>\n \u201cThis is going to be part of the front end of a series of waves of lawsuits at the intersection of technology and all different aspects of our personal and business lives, whether it\u2019s in the privacy context or whether it\u2019s in insurance coverage or whether it\u2019s in antitrust or consumer products,\u201d Clarkson said. \u201cI expect it to be at the fore for some time.\u201d<\/p>\n President Joe Biden signed an executive order<\/a> to establish AI standards in October 2023. For health, the order calls<\/a> for \u201cresponsible use of AI in healthcare\u201d and affordable drug development.<\/p>\n It also requires the Department of Health and Human Services to set up a safety program to take in reports on \u201charms or unsafe healthcare practices involving AI.\u201d<\/p>\n The executive order is \u201cpretty vague,\u201d but sets out \u201creasonable goals\u201d for the HHS, said Nicholson Price, a University of Michigan law professor and faculty affiliate at Harvard\u2019s Project on Precision Medicine, Artificial Intelligence, and the Law.<\/p>\n The Food and Drug Administration is already \u201cmoving at a good clip,\u201d Price said. The agency has established a Digital Health Center of Excellence<\/a>, which works on ways to deal with technologies as they advance and become more integrated with health-care processes.<\/p>\n Likewise, the HHS\u2019 Office of the National Coordinator for Health Information Technology issued<\/a> a rule in December 2023 requiring more transparency around AI.<\/p>\n \u201cHere\u2019s this new technology. We need to figure out how it\u2019s going to be used and how we\u2019re going to regulate it and provide oversight,\u201d Levinson said.<\/p>\n Insurers\u2019 use of advanced technology to analyze claims is \u201cvery frequent,\u201d Levinson said.<\/p>\n Clarkson\u2019s lawsuits accuse UnitedHealthcare and Humana of using AI to decline care for beneficiaries in Medicare Advantage plans. Prior authorization of coverage requests is designed <\/strong>to contain costs and reduce spending for unnecessary care, problems that have dogged traditional Medicare for years.<\/p>\n While MA plans must follow coverage rules for traditional Medicare, they can also use additional \u201cclinical criteria\u201d when making a coverage decision. This can include coverage criteria created by private health-care management companies, the HHS Office of Inspector General said in a 2022 report<\/a>.<\/p>\n Yet <\/strong>what qualifies as appropriate \u201cclinical criteria\u201d wasn\u2019t entirely clear. The OIG report called on the CMS to issue clarifying guidance, including \u201cspecific examples of criteria that would be considered allowable and unallowable.\u201d<\/p>\n The CMS responded by finalizing rules<\/a> requiring Medicare Advantage plans in 2024 to \u201censure that they are making medical necessity determinations based on the circumstances of the specific individual,\u201d rather than by \u201cusing an algorithm or software that doesn\u2019t account for an individual\u2019s circumstances.\u201d<\/p>\n The CMS rule adds that Medicare Advantage plan coverage denials \u201cbased on a medical necessity determination must be reviewed by a physician or other appropriate health care professional.\u201d<\/p>\n But if \u201ccoverage criteria are not fully established\u201d in Medicare regulations, the rule says MA plans \u201cmay create internal coverage criteria under specific circumstances\u201d and \u201can MA plan is permitted to choose to use a product\u201d to \u201cassist in creating internal coverage criteria.\u201d<\/p>\n Not everyone is confident Medicare Advantage plans will adhere to the new rules.<\/p>\n The 30-plus House Democrats want the CMS to issue additional guidance to \u201cincrease oversight of these tools used by MA plans,\u201d their letter said.<\/p>\n In a letter<\/a> to CMS Deputy Administrator Meena Seshamani, Ashley Thompson, senior vice president for public policy analysis and development at the American Hospital Association, said the organization is \u201cdeeply concerned\u201d that MA plans will \u201capply their own coverage criteria that is more restrictive than Traditional Medicare, proliferating the very behavior that CMS sought to address in the final rule.\u201d That could lead to \u201cinappropriate denials of medically necessary care,\u201d Thompson\u2019s letter said.<\/p>\nA Similar Story<\/h2>\n
Medicare Advantage<\/h2>\n
\u2018Deeply Concerned\u2019<\/h2>\n
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