Cancer screening with AI is booming, most not covered by insurance

Artificial intelligence for cancer screening has taken off.

However, most of these new programs are not covered by Medicare or private insurers, creating barriers for companies seeking to drive adoption and for patients who can benefit from the new technology. Â

“Traditionally, for medical devices it takes up to seven years after a product is approved by the FDA to get reimbursed. So it’s quite a challenge,” said Brittany Berry-Pusey, CEO of AI review startup Avenda Health.

As artificial intelligence capabilities accelerate, the Food and Drug Administration has authorized 882 AI and machine learning-enabled devices and software. Nearly 600 of these have been radiological AI applications approved in the past five years. Most do not yet have billing codes that would allow them to receive reimbursement and prevent patients from paying out of pocket.

While some tools have shown early promise to help improve diagnosis and care for cancer patients, more data may be needed to determine whether they are more effective than conventional screening before major insurers are willing to cover them.

One of Avenda’s products illustrates the complex process that must occur before insurers will cover AI tools.

The company’s Unfold AI platform for prostate cancer helps urologists find more cancer cells than traditional MRI exams. It can help identify 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. Just as important, the American Medical Association assigned an interim billing code for it—which most AI radiology products have yet to receive.

Now, Avenda is working to get Medicare and insurers to offer coverage, which can take years in many cases.

“If there’s no copay, 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.

The American Medical Association, the medical professional organization that assigns the current procedural terminology codes that allow reimbursement, issued guidelines for setting AI CPT codes last fall. The group said different medical specialties should help set standards for use in their fields. Â Â Â

Lack of reimbursement is hindering the adoption of new 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 thousands of professionals in the field. However, in a letter to a congressional committee evaluating the use of 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 is “unclear” whether the AI ​​platforms currently being covered are “adding value to patients or the health system.”

Medicare and private health insurers have expressed similar caution. A spokesman for the Centers for Medicare & Medicaid Services told CNBC that the agency considers CPT codes for reimbursement and “continually evaluates opportunities to use new, innovative strategies and technologies safely and responsibly, including Artificial Intelligence.”

Part of that caution may stem from an earlier experience with computer-assisted mammography in the late 1990s. Doctors have since said it led to false positives and unnecessary biopsies. Â

Chief Medical Officer of the Blue Cross of Independence Dr. Rodrigo Cerda said the verdict is still out on the effectiveness of the newer programs.

“The evidence has not quite met the threshold to say that it clearly provides a positive change benefit to our members and does not present other risks that could be false positives or give credence to false negatives,” Cerda said.

No insurance reimbursement, radiology provider Radna used to charge patients a fee for its proprietary AI-enhanced Breast Cancer Detection screening, which launched in 2022. RadNet has published data showing the tool helps improve cancer detection .

The company recently dropped the price of the test from $59 to $40. It said its AI digital health revenue doubled in the first quarter from a year ago and patient adoption AI screening 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 an out-of-pocket fee. By the end of the decade, it was widely covered by insurers.

“The question is, can we finally get it? [insurers] to raise for this? And I think driving adoption and value propositions for finding more cancers, I think will eventually happen. outrun them,” said Dr. Greg Sorensen, chief science officer at RadNet. Â

Sorensen said RadNet has signed up an employer in New Jersey to begin covering breast cancer screenings for its workers.

The company will also will soon launch an AI-enhanced prostate MRI exam for $250. But at that price, it could pose a bigger barrier to adoption — and access for patients who can’t afford it.

UCLA neurology professor Josh Trachtenberg was willing to pay for an AI-powered prostate cancer screening that he believes has made a world of difference to his care. Â

Trachtenburg says that 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.

He turned to a urologist at UCLA’s medical school who was using Avenda Health’s Unfold AI program. The program more accurately measured the extent of his tumor, which allowed the doctor to capture cancer cells during surgery while preserving healthy tissue.

Trachtenberg worries that patients who can’t afford the extra costs for certain AI tools will pay the price with poorer outcomes.

“I think most men who aren’t faculty at a medical school — they just go into 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 miss out on new technologies entirely because the uncertainty of reimbursement could hinder funding for innovation.

“As a startup, we’re always looking for investors, and so making sure there’s a clear path to revenue — it’s important for us to survive,” she said. Â

Investors are backing healthcare AI developers despite payment hurdles. Alex Morgan, a partner at Khosla Ventures, is bullish on the sector and recently participated in a large funding round for a radiology AI firm.

“If you just have a human doing a bunch of activities, and then you keep the AI ​​— you’re not getting any efficiency gains,” Morgan said, adding that the key to getting paid is to “deliver differentiated, robust results . . .

He said that technology that improves quality of care and outcomes for patients will ultimately win.