On Aug. 31 CMS issued a proposed rule that aims to make innovative devices and breakthrough technologies more accessible to Medicare beneficiaries.
Once the Medicare Coverage of Innovative Technology final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization and would continue for four years. This new coverage pathway would offer beneficiaries nation-wide predictable access to new, breakthrough devices to help improve their health outcomes.
The lag time between the FDA’s approval and Medicare establishing coverage prevents seniors from accessing these new technologies during the coverage determination process. 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, according to Becker’s Hospital Review.
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.
The proposal calls for Medicare to provide national coverage simultaneously with FDA approval, for a four-year period. CMS then can reevaluate the device based on clinical and real-world evidence of its impact on Medicare beneficiaries’ health outcomes. The proposed rule would also allow Medicare to cover eligible breakthrough devices the FDA has approved for use in 2019 or 2020 to provide beneficiaries immediate access. The 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.
In an email to MassDevice, AdvaMed President and CEO Scott Whitaker said,
In order to incentivize innovative medical breakthroughs, the federal government must ensure those breakthrough technologies are covered by Medicare. We are pleased that this proposed rule gets us closer to this goal, as it would help ensure the patients who need these innovative technologies have access to them.
Medicare Coverage of Innovative Technology-covered devices would also have to fit Medicare statutory definitions of “reasonable and necessary” for treating patients. Among the requirements, devices would need to be considered:
- Safe and effective
- Not experimental or investigational
- Appropriate for Medicare patients, including the duration and frequency that is considered appropriate and whether it is covered by commercial insurers
Read the fact sheet on the proposed Medicare coverage of innovative technology from CMS.