CMS issued a final rule Jan. 12 that will speed up the FDA approval process for Medicare coverage of new and innovative medical devices and technologies.
Five things to know:
1. The Medicare Coverage of Innovative Technology final rule will reduce the lag time between the FDA's approval of innovative medical tech products and Medicare establishing coverage for the devices.
2. When the proposed rule was published in August 2020, CMS Administrator Seema Verma referred to the approval process as a "chicken and egg issue," adding that "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."
3. The final rule will create a new, accelerated Medicare coverage process for innovative products that the FDA calls "breakthrough," which the FDA approves on an expedited basis and may include devices using new technologies such as implants.
4. The final rule will also let Medicare provide national coverage simultaneously with FDA approval up to a four-year period. Once the four years is up, CMS will reevaluate the device based on clinical and real-world evidence of health outcome improvements among Medicare beneficiaries.
5. After the final rule goes into effect, manufacturers can request that Medicare cover eligible breakthrough devices FDA has approved, including those that received FDA marketing authorization approval within two years before the final rules' effective date.