Artificial intelligence for cancer screening has gained momentum.
However, most of these novel programs are not covered by Medicare or private insurers, making it hard for companies looking to escalate adoption and for patients who could benefit from the novel technology.
“Traditionally, for medical devices, it takes as long as seven years after an FDA-approved product receives reimbursement. So it’s quite a challenge,” said Brittany Berry-Pusey, co-founder and chief operating officer of the AI screening startup. Avenda’s health.
As AI capabilities accelerate, the Food and Drug Administration has approved 882 AI and machine learning-enabled devices and programs. Over the past five years, almost 600 of them have been approved for artificial intelligence applications in radiology. Most do not yet have billing codes that would allow them to be reimbursed and prevent patients from paying out of pocket.
While some tools have already shown promise in improving the diagnosis and care of cancer patients, more data may be needed to determine whether they are more effective than conventional screening tests before major insurers are willing to cover them.
French start-up SquareMind’s medical robot, designed to facilitate cancer screening using artificial intelligence, will be showcased at the Vivatech startup and technology innovation fair at the Porte de Versailles exhibition center in Paris on May 22, 2024.
Julien De Rosa | Af | Getty Images
One of Aveda’s products illustrates the sophisticated process that must occur before insurers embrace AI tools.
Unfold AI’s prostate cancer platform helps urologists find more cancer cells than conventional MRI screening. It can support determine the best treatment to reduce the risk of side effects from prostate cancer surgery, such as urinary incontinence and impotence.
Last year, the FDA approved a medical decision support program. Equally significant, the American Medical Association has designated a short-lived billing code for it, which most AI radiology products have not yet received.
Avenda is currently working to provide coverage to Medicare and insurers, a process that could take years in many cases.
“If there is no payment, it means patients have to pay out of pocket, which can be hard… especially for our patients. This is an older patient population,” Berry-Pusey said.
Obstacles to obtaining reimbursement
Issued by the American Medical Association, the medical organization that assigns current procedural terminology codes for reimbursement guidelines for establishing AI CPT codes last fall. The group said different medical specialties should support define the standards used in their fields.
A lack of reimbursement is making it hard to implement novel artificial intelligence programs in cancer screening, especially in smaller hospitals and doctor’s offices, said Dr. William Thorwarth, CEO of the American College of Radiology, which represents thousands of professionals in the field. However, in letter the Congress committee assessing the utilize of artificial intelligence in health care warned against too hasty actions.
Thorwarth wrote that AI reimbursement is sophisticated and determining billing codes for each approved AI tool is “problematic.” He added that it is “unclear” whether the AI platforms currently covered “add value to 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 options for the protected and responsible utilize of novel, pioneering strategies and technologies, including artificial intelligence.”
Some of this caution may stem from previous experience with computer-assisted mammography in the tardy 1990s. Doctors say this led to false positive results and unnecessary biopsies.
Independence Blue Cross medical director Dr. Rodrigo Cerda said the verdict on the effectiveness of the latest programs is still out.
““The evidence doesn’t yet meet all the criteria to say that it clearly has the benefit of making a positive difference for our members and doesn’t introduce other risks that could be false positives or sort of legitimize false negatives,” Cerda said.
Charging patients out of pocket
No insurance reimbursement, radiology provider RadNet has decided to charge patients for proprietary screening tests using artificial intelligence to detect breast cancer, which began in 2022. RadNet has published data showing that the tool helps improve cancer detection.
The company recently reduced the price of the test from $59 to $40. It said its AI-powered digital health revenues more than doubled in the first quarter compared to a year ago, and the number of patient admissions more than doubled AI-related screening rates increased from approximately 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 test at an additional cost. By the end of the decade it was widely covered by insurance.
“The question is whether we will finally be able to obtain the so-called [insurers] try to get it? I think this will ultimately lead to adoption and the value proposition of finding more cancers to convince them,” said Dr. Greg Sorensen, RadNet’s chief scientific officer.
Sorensen said RadNet has hired an employer in Novel Jersey to begin providing breast cancer screenings for its employees.
The company will do it too will soon introduce AI-enhanced prostate MRI screening for $250. However, at this price, it may pose a greater barrier to adoption and access for patients who cannot afford it.
Access concerns
University of California, Los Angeles neurology professor Josh Trachtenberg was willing to pay for artificial intelligence-based prostate cancer screening, which he believed would significantly improve the quality of his care.
Trachtenburg talks about when he was diagnosed with prostate cancer last year, several doctors told him he would need to have his prostate removed, which would cause urinary incontinence and impotence problems.
He turned to a urologist at the University of California, Los Angeles medical school who used Avenda Health’s Unfold AI program. The program more accurately measured the extent of the tumor, which allowed the doctor to reach cancer cells during surgery while preserving hearty tissue.
Trachtenberg fears that patients who cannot afford the additional costs of some artificial intelligence tools will pay the price with worse outcomes.
“I think most men who aren’t medical school faculty… are just put through the meat grinder because insurance covers it and that’s the ‘go to’ procedure,” he said.
Avenda Health’s Berry-Pusey worries that patients will lose out entirely on novel technologies because uncertainty about reimbursement could make it hard to finance innovation.
“As a startup, we are always looking for investors, so making sure there is a clear path to revenue is significant for us to survive,” she said.
Investors are backing AI creators in healthcare despite payment hurdles. Alex Morgan, partner at Khosla Ventures, is bullish on the industry and recently participated in a vast round of funding for a radiology artificial intelligence company.
“If you just have a human do a bunch of things and then turn on the AI… you’re not going to get any productivity gains,” Morgan said, adding that the key to getting paid is “delivering differentiated, powerful results.”
Ultimately, he said, technology will prevail and improve quality of care and outcomes for patients.
Correction: Brittany Berry-Pusey is Avenda Health’s chief operating officer. An earlier version misrepresented her position.
