Artificial intelligence for cancer prevention is on the rise.
But most of these new programs are not covered by Medicare or private insurers, creating headwinds for companies seeking to increase adoption and for patients who could benefit from the new technology.
“Traditionally, medical devices take up to seven years to receive reimbursement for an FDA-approved product. So that’s quite a challenge,” said Brittany Berry-Pusey, co-founder and COO of AI screening startup Avenda Health.
As AI capabilities continue to accelerate, the Food and Drug Administration has approved 882 AI and machine learning-enabled devices and programs. Almost 600 of these have been approved as radiology AI applications in the last five years. Most do not yet have billing codes that would allow for reimbursement and prevent patients from paying out of pocket.
While some tools have shown early promise in improving diagnosis and care for cancer patients, more data may be needed to determine whether they are more effective than traditional screening before major insurers are willing to cover them.
A medical robot from French startup SquareMind, designed to facilitate cancer prevention using artificial intelligence, is on display during the Vivatech trade fair for technology startups and innovation at the Porte de Versailles exhibition center in Paris on May 22, 2024.
Julien De Rosa | Afp | Getty Images
One of Avenda’s products illustrates the complex process that must occur before insurers will cover AI tools.
The company’s prostate cancer platform Unfold AI helps urologists find more cancer cells than traditional MRI screening. It can help find the best treatment to reduce the risk of prostate cancer surgery side effects, such as incontinence and impotence.
The FDA approved the medical decision support program last year. Equally important, the American Medical Association has established a temporary billing code for it – which most AI radiology products have not yet received.
Now Avenda is working to get Medicare and insurers to provide coverage, which in many cases could take years.
“If there is no payment, that means patients have to pay out of pocket, which can be challenging… especially for our patients. This is an older patient population,” Berry-Pusey said.
Hurdles to reimbursement
The American Medical Association, the medical professional organization that assigns the current procedural terminology codes that enable reimbursement, issued guidelines last fall for establishing AI-CPT codes. The group said different medical specialties should help set the standards for use in their areas of expertise.
The lack of reimbursement is hindering the rollout of new AI cancer screening programs, particularly in smaller hospitals and doctor’s offices, Dr. William Thorwarth, CEO of the American College of Radiology, which represents thousands of professionals in the field. But in a letter to a congressional committee assessing the use of AI in healthcare, he warned 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 was “unclear” whether the AI platforms currently covered “create value for patients or the healthcare system.”
Medicare and private health insurers have expressed similar caution. A spokesperson for the Centers for Medicare & Medicaid Services told CNBC that the agency considers CPT codes in reimbursement and “continuously evaluates opportunities to safely and responsibly use new, innovative strategies and technologies, including artificial intelligence.”
Some of this caution may be due to previous experience with computer-assisted mammography in the late 1990s. Since then, doctors have said this has led to false positive results and unnecessary biopsies.
Dr. Rodrigo Cerda, chief medical officer for Independence Blue Cross, said the jury is still out on the effectiveness of the latest programs.
““The evidence is not quite sufficient to say that it clearly makes a positive difference for our members and does not introduce other risks that could be false positives or give some confidence to the false negatives,” Cerda said.
Charge patients out of their own pockets
No insurance reimbursement, radiology provider RadNet has resorted to charging patients for its proprietary AI screening for advanced breast cancer detection, which launched in 2022. RadNet has published data indicating that the tool is helping to improve cancer detection.
The company recently reduced the price of the test from $59 to $40. It said AI digital health sales more than doubled in the first quarter compared to a year ago, as did patient adoption The number of AI screenings increased from about 25% to 39% of mammography patients.
RadNet executives compare the AI screening process to the radiology industry’s experience with digital breast tomosynthesis, known as 3D mammography. It was approved by the FDA in 2011 and women were initially offered the screening for a co-payment. By the end of the decade it was largely covered by insurers.
“The question is, can we get that at some point [insurers] advocate for it? And I think that driving acceptance and the value proposition of finding more cancers is something I think will happen at some point convince them,” said Dr. Greg Sorensen, Chief Science Officer of RadNet.
Sorensen said RadNet has signed up an employer in New Jersey that will begin covering breast cancer scans for its employees.
The company will do the same will soon launch an AI-powered prostate MRI screening for $250. But at this price, it potentially poses a bigger barrier to adoption — and access for patients who can’t afford it.
Access concerns
Josh Trachtenberg, a professor of neurology at UCLA, was willing to pay for AI screening for prostate cancer, which he said made a big difference to his own treatment.
Trachtenburg says when he was diagnosed with prostate cancer Last year, several doctors told him he would have to have his prostate removed, a procedure that would have left him with incontinence and impotence problems.
He reached out to a urologist at UCLA Medical School who used Avenda Health’s Unfold AI program. The program measured the extent of his tumor more accurately, allowing the doctor to access the cancer cells during surgery while preserving healthy tissue.
Trachtenberg fears that patients who cannot afford the additional costs of certain AI tools will have to pay for them with worse outcomes.
“I think that most men who don’t go to medical school 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 that patients will lose access to new technologies altogether because uncertainty about reimbursement could hinder funding for innovation.
“As a startup, we are always looking for investors and therefore ensure that there is a clear path to sales – this is essential for our survival,” she said.
Despite the payment hurdles, investors are supporting AI developers in healthcare. Alex Morgan, partner at Khosla Ventures, is bullish on the sector and recently participated in a large funding round for a radiology AI company.
“If you just have a human doing a set of activities and then put AI on top of it… you’re not getting efficiencies,” Morgan said, adding that the key to getting paid is “delivering differentiated, high-performing results.”
He said that ultimately the technology that improves the quality of care and outcomes for patients will prevail.
Correction: Brittany Berry-Pusey is COO of Avenda Health. An earlier version misrepresented her point of view.
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2024-05-31 11:13:29
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