CMS issued a proposed rule Aug. 31 that aims to make innovative devices and "breakthrough" technologies more accessible to Medicare beneficiaries.
The Medicare Coverage of Innovative Technology proposed rule is an extension of President Donald Trump's Executive Order on Protecting and Improving Medicare for our Nation's Seniors, which he issued last October. The MCIT proposed rule would speed up the FDA approval process for Medicare coverage of new medical technologies.
Six details:
1. Often referred to as the "valley of death," for innovative medical tech products, the lag time between the FDA's approval and Medicare establishing coverage prevents seniors from accessing these new technologies during the coverage determination process.
"For new technologies, CMS coverage approval has been a chicken and egg issue," CMS Administrator Seema Verma said in the news release. "Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus not widely used enough to demonstrate their suitability for Medicare beneficiaries."
2. The proposed rule would reduce the lag time for both seniors and innovators through the creation of a new accelerated Medicare coverage process for products that the FDA considers "breakthrough," which the agency approves on an expedited basis.
3. The proposal calls for Medicare to provide national coverage simultaneously with FDA approval, for a four-year period. Once the four years passes, CMS can reevaluate the device based on clinical and real-world evidence of its impact on Medicare beneficiaries' health outcomes.
4. The proposed rule would allow Medicare to cover eligible breakthrough devices the FDA has approved for use in 2019 or 2020 so beneficiaries could have immediate access.
5. The proposed rule aims to streamline coverage standards by clarifying the standard CMS uses to determine whether Medicare should cover a product, such as a drug, device or biologic.
6. The public comment period on the proposed rule lasts through Nov. 2.