We didn't fully get it implemented, but the MSIT was a significant policy for Medicare coverage for breakthrough medical devices. This bill requires CMS to provide temporary medical coverage for treatments or devices that receive breakthrough designation from the FDA. If a treatment can meet the FDA's burden of proof of safe and effective and other requirements for breakthrough designation, there's no reason Medicare shouldn't be able to provide temporary medical coverage while CMS completes its review for permanent coverage. (02:08–02:17)
CLAIM
Asserts that HR5343 mandates CMS to offer temporary coverage for FDA-designated breakthrough treatments/devices.
This is an excerpt from a raw transcript. The assertions have not been audited or verified. Tap the video to view the source footage and understand the context.
