CMS has delayed implementation of its contentious breakthrough payment rule until December 15, 2021. The Medicare Coverage of Innovative Technology (MCIT) initiative would give breakthrough devices Medicare reimbursement automatically on the day they are approved or cleared by FDA. Medtech manufacturers pushed for MCIT but high-profile detractors such as health insurance lobby America’s Health Insurance Plans, as well as some doctor groups, drove CMS to delay implementation. The agency said it shares concerns that MCIT could be “problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries.”
January 2021 Rule
The rule sought to established the MCIT pathway to provide beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough devices by the FDA. It additionally aimed to implement a codified regulatory standard that must be used in determining whether all items and services satisfy Medicare’s reasonable-and-necessary requirement.
Under the January 2021 rule, the regulatory changes were originally scheduled to take effect on March 15, 2021. However, following a change in presidential administration, the January 2021 rule became subject to a regulatory freeze. On March 17, 2021, CMS published an interim final rule that delayed the effective date of the January 2021 rule until May 15, 2021, and provided a new comment period to solicit additional feedback. Now, with the considerable length of the most recent delay, CMS will have ample time to evaluate the planned regulatory changes and address any issues raised in stakeholders’ submitted comments. It is also possible that CMS may ultimately rescind the January 2021 Rule entirely.
More on the Pathway
In 2016, Congress passed the 21st Century Cures Act, which codified a new pathway for the FDA to expedite the development, assessment, and review for market approval of innovative medical devices and diagnostic tests via a special “breakthrough” designation. However, Congress did not expressly create a corresponding pathway for CMS to expedite coverage of such breakthrough technologies for Medicare beneficiaries. As a result, even after FDA approval or clearance, Medicare beneficiaries often wait years before being able to take advantage of breakthrough medical technologies and therapies.
The January 2021 rule’s new MCIT pathway, which is voluntary for device manufacturers, would bridge the gap between FDA approval and Medicare coverage. It would provide Medicare beneficiaries with immediate national coverage for four years for any new medical device or diagnostic test designated as a “breakthrough” medical technology and deemed safe and effective by FDA, and then would require CMS and manufacturers to work together to identify and develop any additional data necessary to make a permanent coverage decision after the four-year coverage period expires. Specifically, at the end of the MCIT pathway, a breakthrough technology would either have a favorable National Coverage Determination (NCD), a non-coverage NCD, or coverage decided by a Medicare Administrative Contractor.