Scholar maintains that the FDA has the power to regulate the coverage algorithms used by health insurers.
The recent murder de Brian Thompson, the former CEO of Unitedhealthcare– The largest health insurance company in the United States – has sparked a widespread debate on the practices of insurance companies.
Health insurers are now a more in -depth examination to use Artificial intelligence algorithms (AI) to refuse patient coverage.
In a next article,, Jennifer D. Olivalaw professor at Indiana University Law Schoolargues that the use of unregulated coverage algorithms leads to denials of inappropriate complaints and delays in patient care, resulting in deadly patients. She support The fact that recent federal efforts to reform these algorithms are inadequate because they fail to solve critical problems, such as the long call process, and only apply to specific government programs.
Oliva arguments that the United States and Drug Administration (FDA) has the preexisting power to regulate the coverage algorithms and urges the agency to take measures.
In the United States, health care providers are paid through a acting systemThis means that they are paid for each service or procedure they perform. Insurers argue That this model encourages volume and high cost services, reducing their profits. Consequently, health insurers have subject An increasing number of medical procedures and treatments to a compulsory examination process before the administration of care.
These manual journals, however, take time, subject to human error and to intensify resources, which has resulted in patients with patients.
To control costs and minimize delays, some insurers have designed AI algorithms to automate this process.
Before care is provided, insurers use these algorithms to determine whether a specific treatment recommended by suppliers is “medically necessary” and if this treatment is eligible for coverage within the framework of the patient’s insurance scheme, explain Oliva.
Oliva notesHowever, that the adoption of AI technology has led to a significant increase in the refusal of complaint. According to a report by Permanent Senate of SurveysThe unitedhealthcare denial rate for post-hospital care has more than doubled between 2020 and 2022 after having implemented algorithms to automate its examination process.
Many of these coverage refusals are wrong and illegal, complaints Oliva. Oliva strengths A collective appeal trial Against UNITEDHEALTHCARE alleging that his AI algorithm wrongly denied complaints. The complaint states The fact that around 90% of the refusals of Unitedhealthcare were canceled on appeal by federal judges in administrative law.
Oliva explain Whether these refusals are devastating for patients, who are forced to support a long and expensive call process or pay an unusual option for the average American. Insurers have a financial incitement to refuse complaints, as less than one percent of patients call and others would not survive long enough to finish the process, Oliva underlines.
However, recent measures to regulate these algorithms have been inadequate, arguments Oliva.
THE Centers for Medicare & Medicaid Services (CMS) emitted a ruler requiring that the coverage determinations must “take into account” the patient’s individual circumstances, but it allow Medicare organizations to use algorithms to “help” them to do these determinations.
Oliva arguments That this rule lacks crucial advice for insurers implementing cover algorithms. For example, it does not specify what it means to “use” algorithms or how insurers must “take into account” of individual circumstances in their examination process, states Oliva.
CMS also published a ruler aimed at rationalizing the prior authorization process and improving transparency. The rule need Insurers to disclose which medical articles and services require prior authorization, provide a specific reason for any refusal for suppliers and patients and report information on the prior determinations of the authorization.
Oliva support That this rule cannot resolve many long -standing questions in the examination process. For example, it does not clarify how insurers decide which services require prior authorization, the criteria used for these determinations or how to approach the heavy call process, explain Oliva.
In addition, the CMS rules do not apply to the health plans sponsored by the employer, which covered 60.4% of people under 65 in the United States in 2023, states Oliva.
Oliva arguments This more robust surveillance of these algorithms is necessary “to guarantee their precision, their validity and their equity” before being used by health insurers. Oliva support This FDA already has the regulatory power to do so.
Below Act of food, drugs and cosmeticsThe FDA is granted both the pre-commercial approval authority and expanded post-commerce regulatory powers on “medical devices”. Oliva support These coverage algorithms are considered to be “medical devices” because they make health care treatment decisions by accepting or declining the coverage of patients.
Some medical devices, however, are exempt Of the agency surveillance if a supplier can “independently review the basis” of the refusal of algorithm coverage. To be eligible for this exemption, the manufacturer must describe “The inputs used to generate the recommendation” and “the basis to make a recommendation”, among other details. Oliva notes That insurers claim that their algorithms are owners, preventing them from meeting these transparency requirements.
Even if insurers could meet the requirements of this exception, they would always be subject to the authority of the FDA if the algorithms are “reasonably likely to have serious unfavorable consequences for health”. Given the important results of the health results to which patients with refusal of treatment, these coverage algorithms would not be eligible for exemption, complaints Oliva.
Face some of the highest health care costs in the world, Americans who are denied Insurance coverage could face consequences on life or death. Oliva warnings These coverage algorithms can exacerbate the disalemination between insurance companies and patients, which depend on timely and appropriate care. Oliva call Surveillance of the FDA of these algorithms to ensure that they are accurate and equitable before being used to make determinations that change their life.