Artificial intelligence for cancer screening has taken off.
Yet most of those recent programs aren’t covered by Medicare or private insurers, which creates headwinds for firms trying to boost adoption and for patients who may benefit from the brand new technology. Â
“Traditionally, for medical devices it takes as much as seven years after a product that is approved by the FDA to get reimbursed. So, it is sort of a challenge,” said Brittany Berry-Pusey, co-founder and COO of AI screening startup Avenda Health.
As AI capabilities speed up, the Food and Drug Administration has authorized 882 AI and machine learning-enabled devices and programs. Nearly 600 of them have been radiology AI applications approved within the last five years. Most don’t yet have billing codes that might allow them to get reimbursement and stop patients from paying out of pocket.
While some tools have shown early promise in helping to enhance diagnosis and look after cancer patients, more data could also be needed to find out whether or not they are simpler than conventional screening before major insurers can be willing to cover them.
A medical robot of French begin SquareMind, designed to facilitate cancer screening using artificial intelligence is displayed through the Vivatech technology startups and innovation fair, on the Porte de Versailles exhibition center in Paris, on May 22, 2024.
Julien De Rosa | Afp | Getty Images
One in every of Avenda’s products illustrates the complex process that has to happen before insurers cover AI tools.
The corporate’s Unfold AI prostate cancer platform helps urologists find more cancer cells than traditional MRI screenings. It might aid in identifying the most effective treatment to cut back the danger of prostate cancer surgery unwanted effects like incontinence and impotence.
The FDA approved this system for medical decision support last yr. Just as necessary, the American Medical Association designated a provisional billing code for it — which most AI radiology products haven’t yet received.
Now, Avenda is working on getting Medicare and insurers to offer coverage, which might take years in lots of cases.
“If there is not any payment, meaning patients need to pay out of pocket, which will be difficult … especially for our patients. That is an older patient population,” said Berry-Pusey.
Hurdles to reimbursement
The American Medical Association, the medical skilled organization that assigns the Current Procedural Terminology codes that allow reimbursement, issued guidelines for establishing AI CPT codes last fall. The group said different medical specialties should help determine the standards to be used of their fields. Â Â Â
The dearth of reimbursement is hindering adoption of latest AI programs for cancer screening, especially for smaller hospitals and physician practices, said Dr. William Thorwarth, CEO of the American College of Radiology, which represents hundreds of pros in the sector. Yet, in a letter to a congressional committee assessing using AI in health care, he cautioned against moving too quickly.
Thorwarth wrote that AI reimbursement is complex and establishing billing codes for each approved AI tool is “problematic.”  He added that it’s “unclear” whether the AI platforms currently covered are “adding value to patients or the health system.”
Medicare and personal health insurers have expressed similar caution. A spokesperson for the Centers for Medicare & Medicaid Services told CNBC that the agency takes CPT codes into consideration for reimbursement and “continually assesses opportunities to leverage recent, modern strategies and technologies safely and responsibly, including Artificial Intelligence.”
A part of that caution may stem from an earlier experience with computer-aided mammography within the late Nineties. Doctors since have said it led to false positives and unnecessary biopsies. Â
Independence Blue Cross Chief Medical Officer Dr. Rodrigo Cerda said the decision remains to be out on the effectiveness of the most recent programs.
“The evidence hasn’t quite met the bar to say it clearly makes a good thing about positive difference for our members and doesn’t introduce other risks that is perhaps false positives or kind of gives confidence to the false negatives,” Cerda said.
Charging patients out of pocket
Without insurance reimbursement, radiology provider RadNet has resorted to charging patients a fee for its proprietary Enhanced Breast Cancer Detection AI screening, which was launched in 2022. RadNet has published data indicating the tool helps to enhance cancer detection.
The corporate recently cut the worth of the test from $59 to $40. It said its AI digital health revenue greater than doubled in the primary quarter from a yr ago, and patient adoption of AI screening increased from around 25% to 39% of mammogram patients.
RadNet’s executives compare the method with AI screening to the radiology industry’s experience with digital breast Tomosynthesis, often known as 3D mammography. It was approved by the FDA in 2011, and girls were initially offered the screening for an out-of-pocket fee. By the tip of the last decade, it was widely covered by insurers.
“The query is, can we eventually get the [insurers] to step up for that? And I feel driving the adoption and the worth propositions of finding more cancers, I feel will eventually persuade them,” said Dr. Greg Sorensen, RadNet’s chief science officer. Â
Sorensen said RadNet has enrolled an employer in Recent Jersey, which is able to start covering the breast cancer scans for its staff.
The corporate will even soon launch an AI-enhanced prostate MRI screening for $250. But at that price, it could pose an even bigger barrier to adoption — and access for patients who cannot afford it.
Concerns about access
UCLA neurology professor Josh Trachtenberg was willing to pay for an AI prostate cancer screening, which he feels made a world of difference to his own care. Â
Trachtenburg says when he was diagnosed with prostate cancer last yr, several doctors told him he would wish to have his prostate removed, a procedure that might have left him with incontinence and impotence problems.
He turned to a urologist on the UCLA medical school who was using Avenda Health’s Unfold AI program. This system more accurately measured the scope of his tumor, which allowed the doctor to get on the cancer cells in surgery while preserving healthy tissue.
Trachtenberg worries that patients who cannot afford the additional costs for certain AI tools pays the worth with poorer outcomes.
“I feel most men who aren’t faculty in a medical school … are only put through the meat grinder because that is what insurance covers and that is the ‘go to’ procedure,” he said.
Avenda Health’s Berry-Pusey worries that patients will lose out on recent technologies altogether since the uncertainty of reimbursement could stymie funding for innovation.
“As a startup, we’re at all times searching for investors, and so ensuring that there’s a clear path to revenue — it is vital for us to survive,” she said. Â
Investors are backing health-care AI developers despite the payment hurdles. Alex Morgan, a partner at Khosla Ventures, is upbeat concerning the sector, and recently participated in large funding round for a radiology AI firm.
“If you happen to just have a human do a bunch of activities, and you then stick AI on … you are not getting any efficiency gains,” Morgan said, adding that the important thing to getting paid is to “provide differentiated, powerful outcomes.”
He said that ultimately, the technology that improves the standard of care and outcomes for patients will win out.
Correction: Brittany Berry-Pusey is the COO of Avenda Health. An earlier version of this story misstated her position.
