Cognoa, maker of the first FDA-approved autism diagnostic tool, announced Highmark has signed on as its first commercial payer partner. The tool, Canvas Dx, will now be reimbursed for commercial Highmark members. It aims to enable earlier and more equitable access to diagnosis for children and families without specialists. The tool leverages AI to empower doctors to quickly and accurately diagnose developmental risk without bias, the company claims. The contract should be seen as “model medical policy,” Dennis Wall, Ph.D., autism researcher and founder of Cognoa, told Fierce Healthcare. Wall hopes the coverage will be replicated across other payers. Highmark will cover the full price, including the total cost of CanvasDx and the time it takes for a provider to administer it. Pittsburgh-based Highmark is an innovative, influential payer that Cognoa is excited to partner with, Wall said. In 2022, the plan announced its intention to expand coverage for some prescription digital therapeutics cleared by the Food and Drug Administration, reportedly becoming the first large commercial insurer to signal so. The company has 6 million members in Pennsylvania, Delaware, West Virginia and New York. Last year, Highmark claimed to be the region’s first plan to establish a value-based arrangement for behavioral healthcare. Under the Highmark contract, Canvas Dx can be prescribed by any clinician or advanced practitioner. It does not require prior authorization, and if a parent or physician identifies risk, a doctor can prescribe it at will. This is the first time that any digital solution gets on a medical policy with a price and a code, as far as the company knows, Wall said. “We’re grateful to Highmark for listening to us and for doing the homework to come to the same conclusions we’ve drawn,” he added. Highmark did its own claims analysis to confirm that the costs associated with undiagnosed autism are unsustainable, per Wall. “On average, the median number of visits that a patient would have after having identified risk and prior to a diagnosis is about 15, and the cost of that exceeds a median of $5,000,” Wall said. That cost doesn’t include the expense of the diagnostic itself. And wait times to see a specialist for a diagnosis can range from months to years. In autism care, a primary care physician or pediatrician typically refers a patient to a specialist to get a diagnosis, per Wall, who also runs a lab in Pediatric Innovation at Stanford University. “That’s because they’re not equipped either with the time or skills or training or the tools…to definitively act at the moment the child presents with a risk,” Wall said. Apart from its AI-driven ability to aid in diagnosis, Canvas Dx also features an automatically generated personalized report with a child’s strengths and challenges based on standard criteria known as DSM-5. This helps eliminate the clinician burden of generating a report, per Wall. The report also includes common treatment options and what is typically covered by a given plan. Part of the goal with this milestone for Cognoa is to establish Canvas Dx as the standard of care in the autism space in the coming year, Wall said. Within two years, Cognoa hopes to eliminate provider wait lists and ultimately cut the current average age of diagnosis of 4.5 years by two years, he said. In Wyoming, Arizona and California, Cognoa is participating in an early start program, according to Wall, allowing Canvas Dx to be prescribed and reimbursed under each state’s Medicaid plan. In return, providers offer feedback on adopting the product. Though many states require certain payers to cover diagnosis and treatment, many clinics simply don’t accept insurance, a recent survey sponsored by Cognoa found. Nearly half of centers surveyed don’t take Medicaid, while only two-thirds take commercial insurance.
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