AI Cancer Detection Is Booming, Most Not Covered by Insurance

Artificial intelligence for cancer detection has taken off.

However, most of those new programs are not covered by Medicare or private insurers, creating obstacles for companies looking to drive adoption and for patients who could benefit from the new technology.

“Traditionally, for medical devices, it takes up to seven years after a product has been approved by the FDA to get reimbursed. So it's quite a challenge,” said Brittany Berry-Pusey, CEO from AI detection startup Aveda Health.

As AI capabilities accelerate, the Food and Drug Administration has authorized 882 AI and machine learning-enabled devices and programs. Nearly 600 of these have been approved AI applications in radiology in the last five years. Most still do not have billing codes that allow them to obtain reimbursement and prevent patients from paying out of pocket.

While some tools have shown promise in helping to improve 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.

One of Aveda's products illustrates the complex process that must take place before insurers will cover AI tools.

The company's Unfold AI prostate cancer platform helps urologists find more cancer cells than traditional MRI screening tests. It can help identify the best treatment to reduce the risk of side effects from prostate cancer surgery, such as incontinence and impotence.

The FDA approved the medical decision support program last year. Just as important, the American Medical Association designated it a provisional billing code, which most AI radiology products have not yet received.

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

“If there's no payment, that means patients have to pay out of pocket, which can be a challenge… especially for our patients. This is an older patient population,” Berry-Pusey said.

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

Lack of reimbursement is hindering the adoption of new AI programs for cancer screening, especially for smaller hospitals and doctor's offices, said Dr. William Thorwarth, chief executive of the American College of Radiology, which represents thousands of professionals in field. However, in a letter to a congressional committee evaluating the use of AI in healthcare, he cautioned against moving too quickly.

Thorwarth wrote that AI reimbursement is complex and that establishing 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 and Medicaid Services told CNBC that the agency considers CPT codes for reimbursement and “continually evaluates opportunities to safely and responsibly leverage new and innovative strategies and technologies, including Artificial Intelligence.” .

Part of that caution may be due to a previous experience with computer-assisted mammography in the late 1990s. Doctors have since said it led to false positives and unnecessary biopsies.

Dr. Rodrigo Cerda, medical director for Independence Blue Cross, said the verdict is still out on the effectiveness of the newer programs.

““The evidence has not met the requirements to clearly say that it makes a positive benefit or difference for our members and does not introduce other risks that could be false positives or that in some way gives confidence to false negatives,” Cerda said.

No insurance reimbursement, radiology provider RadNet has resorted to charging patients a fee for its proprietary AI-enhanced Breast Cancer Screening, which launched in 2022. RadNet has published data indicating the tool helps improve cancer detection.

The company recently reduced the price of the test from $59 to $40. It said its AI digital health revenue more than doubled in the first quarter from a year earlier, and patient adoption The percentage of AI screening increased from about 25% to 39% of mammography patients.

RadNet executives compare the process with AI screening 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 test for an out-of-pocket fee. By the end of the decade, insurers widely covered it.

“The question is: can we finally get the [insurers] step forward for that? And I think driving adoption and the value propositions of finding more cancers, I think eventually convince them,” said Dr. Greg Sorensen, RadNet's chief scientific officer.

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

The company also It will soon launch an AI-enhanced prostate MRI exam for $250. But at that price, it can pose a greater 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 test, which he said made a big difference in his own care.

Trachtenburg tells when he was diagnosed with prostate cancer Last year, several doctors told him he would need to have his prostate removed, a procedure that would have left him with incontinence and impotence.

He turned to a urologist at UCLA Medical School who was using Aveda Health's Unfold AI program. The program more accurately measured the extent of their tumor, allowing the doctor to reach the cancer cells in surgery while preserving healthy tissue.

Trachtenberg worries that patients who can't afford the additional costs of certain AI tools will pay the price with worse outcomes.

“I think most men who aren't medical school professors…they just get put through the meat grinder because that's what insurance covers and that's the go-to procedure,” he said.

Aveda Health's Berry-Pusey worries that patients will miss out on new technologies entirely because reimbursement uncertainty could hamper funding for innovation.

“As a startup, we are always looking for investors, so making sure there is a clear path to revenue is important for us to survive,” he said.

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 an artificial intelligence company in radiology.

“If you just have a human do a bunch of activities and then apply AI to it… you're not going to get any efficiency gains,” Morgan said, adding that the key to getting paid is “delivering differentiated and powerful results.”

In the end, he said, technology that improves the quality of care and outcomes for patients will win.