The FDA has approved nearly 600 radiology artificial intelligence and machine learning programs and devices over the last five years, but most aren't covered by insurance.
"Traditionally, for medical devices it takes up to seven years after a product that's approved by the FDA to get reimbursed. So, it is quite a challenge," said Brittany Berry-Pusey, CEO of AI screening startup The company's Unfold AI prostate cancer platform helps urologists find more cancer cells than traditional MRI screenings. It can aid in identifying the best treatment to reduce the risk of prostate cancer surgery side effects like incontinence and impotence.
Medicare and private health insurers have expressed similar caution. A spokesperson for the Centers for Medicare & Medicaid Services told CNBC that the agency takes CPT codes into account for reimbursement and "continually assesses opportunities to leverage new, innovative strategies and technologies safely and responsibly, including Artificial Intelligence."
He turned to a urologist at the UCLA medical school who was using Avenda Health's Unfold AI program. The program more accurately measured the scope of his tumor, which allowed the doctor to get at the cancer cells in surgery while preserving healthy tissue.