Artificial intelligence for cancer screening has already taken off.
However, most of these new programs are not covered by Medicare or private insurance companies, creating a headwind for companies looking to increase adoption and the patients who could benefit from the new technology.
“Traditionally, for medical devices, it takes up to seven years for a product to be approved by the FDA,” said Brittany Berry-Pusey, CEO of an artificial intelligence screening startup. Get reimbursed. avenda health.
As artificial intelligence capabilities accelerate, the U.S. Food and Drug Administration has authorized 882 devices and programs that support artificial intelligence and machine learning. Nearly 600 of these radiology AI applications have been approved in the past five years. Most also don’t have billing codes that would allow them to be reimbursed and prevent patients from paying out of pocket.
While some tools have shown early promise in helping improve diagnosis and care for cancer patients, more data may be needed to determine whether they are more effective than traditional screening before major insurance companies are willing to cover them.
A medical robot from French startup SquareMind, designed to use artificial intelligence to facilitate cancer screening, was showcased at the Vivatech Technology Startups and Innovation Expo at the Porte de Versailles Exhibition Center in Paris on May 22, 2024.
Julian de Rosa | AFP | Getty Images
A product from Avenda illustrates the complex process that must be completed before an insurance company can underwrite an AI tool.
The company’s Unfold AI prostate cancer platform helps urologists find more cancer cells than traditional MRI screening. It can help determine the best treatment to reduce the risk of side effects of prostate cancer surgery, such as incontinence and impotence.
The FDA approved the medical decision support program last year. Just as important, it was assigned a temporary billing code by the American Medical Association—a code that most AI radiology products have yet to receive.
Now, Avenda is working to get Medicare and insurance companies to provide coverage, which in many cases can take years.
“If there’s no payment, that means the patient has to pay out of pocket, which can be challenging … especially for our patients. This is an older patient population,” Berry-Poussey said.
Reimbursement Barriers
The American Medical Association, the medical professional organization that designates current procedural terminology codes that allow for reimbursement, issued A guide to creating AI CPT codes last fall. The organization said different medical specialties should help determine standards for use in their respective fields.
Dr. William Thorwarth, CEO of the American College of Radiology, which represents thousands of professionals in the field, said a lack of reimbursement is hindering the adoption of new artificial intelligence programs in cancer screening, especially for smaller hospitals and physician offices. However, in a letter He warned against moving too quickly as he told a congressional committee assessing the use of artificial intelligence in health care.
Thorwarth wrote that AI reimbursement is complex and establishing billing codes for each approved AI tool is “problematic.” He added that it was “unclear” whether the AI platforms currently covered “add value to patients or the health system”.
Medicare and private health insurers have expressed similar caution. A spokesperson for the Centers for Medicare and Medicaid Services told CNBC that the agency considers CPT codes when reimbursing and “continuously evaluates opportunities to safely and responsibly leverage new innovative strategies and technologies, including artificial intelligence.”
Part of this caution may stem from early experiences with computer-assisted mammography in the late 1990s. Doctors have since said this led to false positives and unnecessary biopsies.
Dr. Rodrigo Cerda, chief medical officer for Independent Blue Cross, said no conclusions had yet been drawn on the effectiveness of the latest plan.
“The evidence is not quite up to par to clearly show that it delivers the benefit of a positive difference to our members and does not introduce other risks that could be false positives or give confidence in false positives,” Cerda said.
Charge patients out of pocket
No insurance reimbursement for radiology providers Radnet Its proprietary enhanced breast cancer detection AI screening is launching in 2022 and will be billed to patients.
The company recently lowered the price of the test from $59 to $40. The company said artificial intelligence digital health revenue more than doubled year-over-year in the first quarter and patient adoption rates also increased. AI screening rates among mammography patients increased from about 25% to 39%.
RadNet executives compared the AI screening process to the radiology industry’s experience with digital breast tomosynthesis, or 3D mammography. The program, approved by the FDA in 2011, initially provided screening services at women’s expense. By the end of the century, it was widely covered by insurance companies.
“The question is, can we finally get (insurance companies) to take action? I think the value proposition that drives adoption and finding more cancers will ultimately be persuade them,” said Dr. Greg Sorenson, RadNet’s chief scientific officer.
Sorensen said RadNet has registered an employer in New Jersey that will begin paying for breast cancer scans for its employees.
The company will also Artificial intelligence-enhanced prostate MRI screening is coming soon, priced at $250. But at that price, it could pose greater barriers to adoption and use among patients who can’t afford it.
Concerns about access
Josh Trachtenberg, a professor of neurology at UCLA, is willing to pay for an AI-powered prostate cancer screening that he believes will have a huge impact on his own care.
Trachtenberg says when he was diagnosed with prostate cancer Last year, several doctors told him he needed to have his prostate removed, a procedure that could cause him incontinence and impotence problems.
He turned to a urologist at the UCLA School of Medicine, who was using Avenda Health’s Unfold AI program. The procedure more accurately measured the extent of his tumor, which allowed doctors to find cancer cells during surgery while sparing healthy tissue.
Trachtenberg worries that patients who can’t afford the extra cost of some AI tools will pay the price with worse outcomes.
“I think most men who are not medical school faculty … are just put through the meat grinder because that’s what insurance covers and that’s the ‘go to’ procedure,” he said.
Avenda Health’s Berry-Pusey worries patients will lose out on new technologies altogether, as reimbursement uncertainty could stymie funding for innovation.
“As a startup, we are always looking for investors, so making sure there is a clear path to revenue — that’s important for our survival,” she said.
Despite payment barriers, investors are backing healthcare AI developers. Alex Morgan, a partner at Khosla Ventures, is optimistic about the industry and recently participated in a large funding round for a radiation artificial intelligence company.
“If you just ask a human to do a series of activities and then you stick to artificial intelligence … you’re not going to get any efficiency gains,” Morgan said. The key to getting paid, he added, is to “deliver differentiated, powerful results. ”.
Ultimately, he said, technology that improves the quality of patient care and outcomes will win.
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