A device can be cleared by the FDA, stocked by a manufacturer, and recommended by a physician, and Medicare can still decline to pay for it. That is not an error in the system. It is how the system is built.
The FDA decides whether a device is safe and effective enough to be sold. The Centers for Medicare and Medicaid Services decides, separately, whether Medicare will pay for it: two agencies, two statutory standards, two timelines. Under the current process, the gap between market authorization and national Medicare coverage runs roughly a year or more, according to CMS's own description.
