CMS issues proposed rule to cover ‘breakthrough’ medical devices

The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule this week that would give breakthrough medical devices national Medicare coverage on the same day they receive FDA approval for four years. The proposed rule, called Medicare Coverage of Innovative Technology (MCIT), would establish a Medicare coverage pathway that provides beneficiaries nationwide with faster access to new, innovative medical devices designated as ‘breakthrough’ by the Food and Drug Administration (FDA).

During the four year timeframe, CMS recommends that manufacturers develop additional evidence showing the applicability of their products to Medicare beneficiaries so they can apply for further coverage.

Before the MCIT, after a breakthrough technology receives FDA approval, an often lengthy and costly process for Medicare coverage begins. That period has been challenging for companies because innovators spent time and resources to achieve FDA approval, only to need to spend more time and money to acquire Medicare coverage. This lag time is not only costly but has also reduced access to innovative technologies by senior populations.

This proposed rule follows up on creating a pathway to Medicare coverage the same day as FDA market authorization for breakthrough devices. The proposal will be live from September 1, 2020 and open for comment till October 30, 2020. Additionally, the proposed rule would allow Medicare to cover eligible breakthrough devices the FDA has approved for use in 2019 or 2020.

What does it mean for you?

Organizations will need to understand the details of the breakthrough designation and how it applies to their innovation before proceeding. Moreover, what evidence needs to be generated in these four years to maintain coverage. The Alira Health team can help you understand how this designation applies to you, and how you can best leverage the proposed rule for your innovation.

For more information, please contact Deepak Sahu, deepak.sahu@alirahealth.com. 

Click here to see the proposed rule from The Department of Health and Human Services.