“It’s good government, and it’s good common sense to recognize that if doctors and scientists at the FDA – the global gold standard for medical technology regulation – determine a device is safe and effective, another federal agency can then move quickly to ensure patients can access that lifechanging and often lifesaving technology. We urge the incoming administration to keep this important step forward for our seniors in place, and we look forward to working closely with them on its implementation.”
Under the final rule, CMS will provide immediate national coverage for four years for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA. During that four-year coverage period, CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.