CMS Issues Final Rule

CMS issued a final rule so Medicare beneficiaries will have access to the latest and most advanced devices. The Medicare Coverage of Innovative Technology (MCIT) final rule will provide more than 60 million Medicare beneficiaries access to the latest medical technology faster than ever.

Under current rules, FDA’s approval of a device is followed by an often lengthy and costly process for Medicare coverage. The MCIT rule will create a new accelerated Medicare coverage pathway for innovative products that FDA deems breakthrough and will approve on an expedited basis.

The rule could include devices harnessing new technologies like implants or gene-based tests to diagnose or treat life-threatening or irreversible debilitating diseases or conditions like cancer and heart disease.

After the final rule takes effect, if manufacturers request, Medicare may cover through MCIT eligible breakthrough devices that the FDA has approved. This includes breakthrough devices that have received FDA marketing authorization approval within two calendar years prior to the final rule’s effective date.



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