The Centers for Medicare and Medicaid Services (CMS) published a final rule this week that creates a new, voluntary pathway for immediate, national Medicare coverage for medical technologies approved by the FDA with a breakthrough designation.

CBSA applauds this action by CMS to ensure patients have access to innovative technologies approved by the FDA. In recent years, we have worked closely with our medical technology partners to advocate for a transitional coverage pathway for breakthrough devices and diagnostics. When CMS issued the proposed rule last year, CBSA joined other state bioscience associations in submitting comments in support and urged the agency to finalize the rule.

The new pathway for Medicare Coverage of Innovative Technologies (MCIT) provides immediate national Medicare coverage for FDA-designated breakthrough devices and diagnostics that have market authorization.  The initial coverage period created by this pathway can be up to four years. After that time, CMS will reevaluate the device or diagnostic based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries to determine more permanent coverage. 

Under the MCIT final rule, medical technology innovators will have the option to choose when they would like coverage to begin. This change from the proposed rule aims to provide companies with needed flexibility to align the coverage process with their manufacturing and distribution cycles.

The final rule also clarifies the standard CMS uses to determine whether Medicare should cover items and services like devices and surgical procedures. Under the Medicare program, CMS can only cover items and services that are “reasonable and necessary”. The final rule will codify CMS’ definition of reasonable in necessary to give life sciences innovators a clear understanding of CMS standards.

Learn more about the MCIT final rule in the CMS fact sheet.

This is an important outcome for CBSA’s members and the patients we serve. It means when the FDA determines a breakthrough device or diagnostic is safe and effective, Medicare patients will have access to that technology without unnecessary delays.

In the coming weeks, CBSA will work with our members and industry partners to ensure that the MCIT final rule is implemented. It goes into effect on March 15, 2021.