On March 17, 2021, the Centers for Medicare and Medicaid Services (CMS) published in the Federal Register an interim final rule that delayed the effective date of the Medicare Coverage of Innovative Technology (MCIT) rule by 60 days until May 15, 2021 and provided a 30-day public comment period to solicit additional feedback.
This news is, in a word, disappointing.
The delay in implementing the MCIT rule could unnecessarily jeopardize the health and well-being of Medicare beneficiaries with very serious illnesses or conditions who will be unable to obtain timely and appropriate access to “breakthrough” medical technologies.
Back in 2016, Congress passed the 21st Century Cures Act which codified a new pathway for the Food and Drug Administration (FDA) to expedite the development, assessment, and review for market approval – and, subsequently, distribution to patients – of innovative medical devices and diagnostic tests via a special “breakthrough” designation. Notably, FDA specifically reserves such designation for those medical technologies that treat patient populations with debilitating conditions for which there are limited or no treatment alternatives. Despite this bipartisan success, however, Congress did not 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, seniors covered by Medicare must often wait years before taking advantage of these critical new medical technologies and therapies.
The MCIT final rule bridges the gap between FDA approval and CMS coverage. That is, the regulation provides 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 expects that CMS and manufacturers will work together to identify and develop any additional data necessary to make a permanent coverage decision after the 4-year coverage period expires.
The breakthrough technologies that have been approved by the FDA will help patients with heart failure, diabetes, emphysema or to diagnose advanced cancers – conditions considered life-threatening or irreversibly debilitating and for which alternative treatments do not exist.
With hope that the recent delay is only a temporary setback, AdvaMed is strongly committed to continuing our advocacy on all fronts and working with the Biden administration to ensure that the MCIT rule is implemented fully so that America’s seniors and other Medicare beneficiaries have equitable access to life-saving medical innovations.
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