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This bill amends Medicare law to establish a pathway for prompt coverage of breakthrough medical devices. It creates a 4-year transitional coverage period during which breakthrough devices (those designated by the FDA as receiving priority review) would be covered by Medicare, provided they are used according to FDA-approved labeling and do not present undue risk. The bill requires the Secretary of Health and Human Services to issue final coverage determinations for these devices before the transitional period ends and appropriates $10 million annually through 2030 to implement the program.
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