CMS releases Proposed Medicare Coverage of Innovative Technology (CMS-3372-P)
The Centers for Medicare and Medicaid Services (CMS) proposed a new Medicare coverage pathway, the Medicare Coverage of Innovative Technology (MCIT), for FDA-designated breakthrough devices. This pathway would offer beneficiaries access to new and innovative devices and technologies to help improve their health outcomes, by providing national Medicare coverage on the same day as the FDA market authorization for breakthrough devices. This coverage would last four years.
The breakthrough device designation is only given to devices that meet specific criteria from the 21st Century Cures Act. A breakthrough device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition. It must also meet at least one part of a second criterion, such as by being a “breakthrough technology” or offering a treatment option when no other cleared or approved alternatives exist. For beneficiaries impacted by these diseases, MCIT will provide assurance that they will have access to the latest breakthrough medical devices to treat their condition, provided the devices have a Medicare benefit category.
When the FDA market authorizes a device, it is for specific use(s). The breakthrough device must be used for the FDA approved or cleared indication for use (FDA label or indication) in order for MCIT. Devices not used for the approved or cleared indication are not covered under MCIT.
CMS believes 4 years of Medicare coverage would allow clinical studies to be completed with Medicare patients by device manufacturers. This would provide evidence of the devices’ clinical efficacy. When the MCIT coverage sunsets, manufacturers will then have coverage options such as a National Coverage Determination (NCD), Local Coverage Determinations (LCD) and claim by claim decisions.
Device manufacturers interested in the MCIT pathway should notify CMS of their interest via email. CMS will coordinate with the FDA and the manufacturer to ensure a good start of coverage once the breakthrough device is FDA market approved. However, manufacturers would still be responsible for obtaining codes for the device.
A list of breakthrough devices covered under MCIT with their corresponding duration of coverage would be available on the CMS website.
The entire proposal can be reviewed here: https://www.federalregister.gov/documents/2020/09/01/2020-19289/medicare-program-medicare-coverage-of-innovative-technology-mcit-and-definition-of-reasonable-and.
