Foley & Lardner LLP Partner Rachel Goodman is quoted in the Politico article, “Sorry, the government’s not paying for your therapy app,” discussing the bureaucratic hold ups for companies offering digital therapeutic products.
While the U.S. Food and Drug Administration has cleared dozens of digital therapeutic products, the lack of an accepted definition of what one precisely is has prevented the Centers for Medicare and Medicaid Services (CMS) from reimbursing providers. CMS lacks a benefit category for digital therapeutics or software as a medical device, and the U.S. Congress has to approve new reimbursement categories. These delays have meant the companies offering these digital therapies are having difficulty gaining traction.
“This is just another example of the law is not quite catching up with where innovation is,” said Goodman.