Federal regulators on Thursday announced a new Medicare coverage pathway for devices deemed breakthroughs by the Food and Drug Administration. The program aims to address longstanding industry complaints that it takes too long for Medicare to pay for innovative technology.
The new Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, will try to synchronize the FDA’s premarket review process, which determines whether products are safe and effective, and Medicare’s independent process which determines whether paying for devices is reasonable and necessary. The goal is to collect and review enough data before authorization that Medicare can cover the products soon after a product hits the market. It’s the latest effort to speed up patient access to breakthrough devices.
“We’re going to demystify the process by providing a clear signal to device manufacturers of exactly what targets they need to hit to get Medicare coverage,” said Medicare Deputy Administrator John Brooks. “And that’s enormously valuable, if you think about the investment timelines for device manufacturers who are trying to bring life-saving treatments to individuals.”
