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New Rule Eliminates Time Between FDA Approval and Medicare Coverage

A recent rule change will eliminate the waiting period that takes place between the time certain medical devices are approved by the FDA and when Medicare beings covering them.

A recent Medicare rule change will put the latest technologies into the hands of seniors faster and more efficiently. 

Under current Medicare protocol, there is typically a lengthy and costly period of time between when a medical device gains Food and Drug Administration (FDA) approval and when Medicare begins covering the device. The new Medicare Coverage of Innovative Technology (MCIT) ruling aims to expedite that process and eliminate the waiting period for certain devices. 

The rule, issued January 12, will create an accelerated pathway for Medicare beneficiaries to access technologies deemed to be “breakthrough” by the FDA. These are typically devices used to diagnose or treat life-threatening or debilitating diseases like cancer and heart disease, and they use the latest technology to do so. 

Such medical devices are typically covered by Medicare Part B or Medicare Advantage plans.

What does the MCIT rule mean for Medicare beneficiaries?

Under the MCIT rule, Medicare coverage of medical technology can begin simultaneously with FDA approval, for up to four years. Once that initial coverage period ends, Medicare will reevaluate the effectiveness of the device’s use based on clinical and real-life evidence to make a more permanent coverage decision.

The four-year window allows manufacturers of the medical devices time to improve their product in advance of a possible permanent Medicare coverage incentive.  

Former CMS Administrator Seema Verma said in a press release announcing the ruling, “Government processes have slowed beneficiaries’ access to innovative treatments. Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices.”

Coverage of these breakthrough devices will be nationwide and not dependent on location. The innovators of the devices will get to choose when they would like Medicare coverage to begin in order to help align the coverage process with manufacturing and distribution cycles. 

Additionally, the MCIT rule may be applied retroactively to cover breakthrough devices developed within the two years prior to the rule change that have not yet been cleared for Medicare coverage.