THE CHALLENGE:
During a stroke, blood can’t reach your brain to deliver nutrients and oxygen. A few minutes can often mean the difference between successful intervention, brain damage or death.
Artificial intelligence (AI) software as a medical device can decrease the time it takes to make a diagnosis and deliver treatment during a medical emergency—for example, Viz.ai software can identify a potential stroke in a patient directly from a CT scan and alert a stroke neurologist. However, because it’s expensive, not all providers and patients have access.
To ensure Medicare payment isn’t a barrier to investing in cutting-edge technology for better patient care, the Centers for Medicare & Medicaid Services (CMS) provides an additional payment for certain new technologies through a policy called the New Technology Add-on Payment (NTAP). However, no AI software as a medical device had previously been approved for NTAP.
THE OBJECTIVE:
Viz.ai tasked our McDermott+Consulting (McDermottPlus) team with helping them secure NTAP for their product. The promise of NTAP would support hospital adoption of Viz.ai technology and improve stroke patient outcomes.
THE OUTCOME:
In a win for the AI industry and for Viz.ai’s business, CMS granted them the first-ever NTAP for AI software as a medical device.
The decision to award a NTAP, and the amount of the additional payment, depends on the newness of the technology and its cost, along with evidence that the technology provides substantial clinical improvement. With a lack of AI technology in healthcare, Viz.ai and CMS found themselves in uncharted territory.
To make a strong argument in favor of granting a NTAP for Viz.ai, the McDermottPlus team masterfully demonstrated how existing frameworks for evaluating technologies for NTAP may be applied to AI technology, and they collaborated with CMS on an approach for measuring the cost of subscription-based technologies.
DIG DEEPER:
Using previous experience in NTAP applications, the McDermottPlus team worked closely with Viz.ai and our advocacy, policy and data analytics departments to build a detailed case and make a persuasive presentation to CMS.
Viz.ai’s work with McDermottPlus has established a precedent for AI companies looking to get NTAP for their products.