Situation Report | January 18, 2021
The U.S. Centers for Medicare and Medicaid Services (CMS) issued a final rule that “propels innovative technology so Medicare beneficiaries have access to the latest, most advanced devices.”
The Medicare Coverage of Innovative Technology (MCIT) final rule will create a new, accelerated Medicare coverage pathway for innovative products that the Food and Drug Administration (FDA) deems “breakthrough,” which FDA approves on an expedited basis. This could include devices harnessing new technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversibly debilitating diseases or conditions like cancer and heart disease.
Under the MCIT rule, Medicare can provide national coverage simultaneously with FDA approval, up to a period of four years. After the coverage period is over, CMS will reevaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries to determine more permanent coverage. This four-year timeline may incentivize the manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years.