The increasing use of artificial intelligence and advanced technology in the medical field has sparked a wave of litigation, and lawyers expect more cases in the coming months.
Insurance company
The lawsuit comes as Congress and the Biden administration intensify efforts to create a legal framework around the rapidly expanding role of artificial intelligence in health care.
“AI is permeating every aspect of our lives, and regulators and lawmakers are trying to catch up, but to no avail,” said Clarkson LLP, a public interest firm leading lawsuits against insurance companies. Founder Ryan Clarkson said.
Two of Clarkson's lawsuits focus on technology used to determine beneficiary coverage in Medicare managed care plans.
These private Medicare Advantage plans have come under intense scrutiny from lawmakers, regulators, and patients for using prior authorizations, or “prior authorizations,” to deny coverage typically granted under pay-as-you-go Medicare. I am. More than 30 House Democrats said the problem was exacerbated by the plan's increased use of “enterprise-managed AI or algorithmic software” like naviHealth and CareCentrix to “assist in determining coverage.” states that it is possible.
These AI-powered tools analyze data that helps insurance companies make coverage decisions. Michael Levinson, a partner at Berger Singerman LLP and a licensed physician, said insurers “have to use” advanced technology. “The volume of complaints is huge.”
UnitedHealth Group spokesman Eric Hausman said in an email response that the company's naviHealth prediction tool is not used to determine coverage.
Coverage decisions are based on the terms of the member's plan and the Centers for Medicare and Medicaid Services coverage standards, Hausman said.
“Adverse coverage decisions are made by the physician's medical director and are consistent with Medicare coverage standards for Medical Advantage plans,” Hausman said. “This lawsuit has no merit and we will vigorously defend it.”
similar story
Clarkson spoke with dozens of Medicare Advantage policyholders, whistleblowers, nonprofit organizations and public interest attorneys. He says they all tell similar stories. Insurers are using AI and algorithms “to improve profits in the name of providing better service to policyholders,” the report said.
Glenn Danas, a partner at Clarkson Law, said the firm has identified at least three other insurance companies that are using advanced technology to prematurely deny claims.
He also noted that doctors, diagnostic companies and others are contacting them about inappropriate use of technology because they are “very frustrated that they can't provide the care they want.”
“This is the culmination of a series of lawsuits where technology intersects with many different aspects of our personal and business lives: whether it’s in the context of privacy, whether it’s insurance coverage, whether it’s the application of law. It's going to be part of the front lines: antitrust and consumer products,'' Clarkson said. “We expect that to be at the forefront for some time.”
President Joe Biden signed an executive order establishing AI standards in October 2023. Regarding health, the executive order calls for “the responsible use of AI in health care” and the development of affordable medicines.
It also calls for the Department of Health and Human Services to launch a safety program to accept reports of “harm or unsafe medical practices involving AI.”
Nicholson Price, a University of Michigan law professor and faculty member of Harvard University's Precision Medicine, Artificial Intelligence, and Law Project, said the executive order is “quite vague” but sets “reasonable goals” for HHS. Stated.
Price said the Food and Drug Administration is already “on track.” The agency has established a Digital Health Center of Excellence to address ways to address technology as it advances and becomes more integrated into healthcare processes.
Similarly, HHS' Office of the National Coordinator for Health Information Technology issued a rule in December 2023 calling for increased transparency regarding AI.
“This is new technology. We need to understand how it will be used and how to regulate and monitor it,” Levinson said.
Medicare Advantage
Levinson said it is “very common” for insurance companies to use advanced technology to analyze claims.
Clarkson's lawsuit accuses UnitedHealthcare and Humana of using AI to deny care to Medicare Advantage plan beneficiaries.Pre-approval of interview requests is designed Containing costs and cutting spending on unnecessary health care, a problem that has long plagued traditional Medicare.
MA plans must follow traditional Medicare coverage rules, but can also use additional “clinical criteria” when determining coverage. This could include applicable standards developed by private health care management companies, the HHS Office of Inspector General said in a 2022 report.
still It was not entirely clear what would qualify as appropriate “clinical standards.” The OIG report called on CMS to issue clear guidance that includes “specific examples of acceptable and unacceptable standards.”
CMS responded by requiring Medicare Advantage plans in 2024 to “determine medical necessity based on a specific individual's circumstances, rather than using algorithms or software that do not take that individual's circumstances into account.” finalized regulations mandating. ”
CMS regulations add that denials of Medicare Advantage plan coverage “must be reviewed by a physician or other appropriate health care professional based on a determination of medical necessity.”
However, if “coverage standards are not fully established” under Medicare regulations, the rules state that MA plans “may create internal coverage standards under certain circumstances” and that “MA plans may create internal coverage standards.” “You may choose to use the product to support your organization.” standard. “
“We are deeply concerned.”
Not everyone is convinced that Medicare Advantage plans will follow the new rules.
The letter says more than 30 House Democrats are asking CMS to issue additional guidance to “strengthen oversight of these tools used in MA plans.” .
Ashley Thompson, senior vice president of public policy analysis and development at the American Hospital Association, wrote in a letter to Meena Seshamani, CMS deputy administrator, that the association expects the MA plan to be “more limited and unique. We are deeply concerned about the application of applicable standards.” Even more than traditional Medicare, it pervades the very practices that CMS sought to address in the final rule. ” Thompson's letter says that could lead to “inappropriate denial of medically necessary care.”
Six health care provider groups representing Medicare beneficiaries and post-acute care providers expressed similar concerns in separate letters to Seshamani.
The group asked CMS to issue additional regulations prohibiting “the use of algorithms and artificial intelligence to deny coverage” and restricting “other uses of these tools until a systematic review of their use is completed.” It calls for guidance to be issued.
David Allen, a spokesperson for America's Health Plans, said in an emailed statement that the organization is working with the government to “ensure the responsible use of AI while maintaining America's leadership in medical advancement.” “We stand ready to work to create appropriate federal oversight.”
“Regulatory frameworks requiring government reporting should build on existing industry standards and focus on high-risk applications,” the statement added.
The future of litigation
Nevertheless, the use of AI in insurance claim denials is “likely to become even more common in the near future,” Price said.
“We're going to see more lawsuits like this,” Levinson said. “Until this technology is regulated and better understood, more and more plaintiffs' attorneys will look to other insurance companies to see if there is a potential case.”
Jeffrey Rottenberg, an attorney with the law firm Berger Singerman, said the use of AI to deny claims should ultimately create “legal precedent interpreting bad faith statutes.”
If one of Clarkson's lawsuits goes “a step further” and “defines the scope” of the use of AI in claim denials, Rottenberg said it could prompt states and the federal government to set standards. .
