Fierce Health Technology January 12, 2021
The Trump administration finalized a rule Tuesday that will grant faster Medicare coverage decisions on new breakthrough medical devices.
The rule will tackle the lag time between when a new device is approved or cleared by the Food and Drug Administration and when it gets covered by Medicare, a time the administration refers to as the “valley of death” for innovative products, officials have said. The rule creates an accelerated Medicare coverage pathway for “breakthrough” devices, or those which the FDA approves on an expedited basis.
For example, officials said, it coud be used for devices which harness technologies like implants or gene-based tests to diagnose or treat conditions like cancer or heart disease. Under the rule, officials said,...
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