In January, CMS finalized a new rule called Medicare Coverage of Innovative Technologies (MCIT). The rule provides immediate national Medicare coverage for FDA-designated breakthrough devices and diagnostics that have market authorization. The initial coverage period created by the pathway can be up to four years, and after that time, CMS would 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. 

CBSA strongly supports the MCIT rule, which would improve Medicare beneficiary access to breakthrough technologies that are approved or cleared by the FDA. There is often a gap between the FDA approval of breakthrough medical devices and coverage decisions made by CMS, causing significant delays in patient access to groundbreaking technologies, and we believe this is a critical step in addressing that gap.

The MCIT rule was scheduled to go into effect on March 15, but a few days before that date, CMS issued a new interim final rule that delayed implementation for at least 60 days (May 15) and opened up a new 30-day comment period.

Last week CBSA joined other state life sciences associations in submitting comments to CMS, urging the agency to implement the MCIT rule without further delay.

Read the State Medical Technology Alliance (SMTA) comment letter to CMS.

CBSA is working closely with our members and industry partners to educate policymakers about benefits of the MCIT rule. We will continue to advocate for full implementation, so Medicare beneficiaries have access to new and innovative technologies as soon as possible.