H.R. 5343 — Ensuring Patient Access to Critical Breakthrough Products Act

This section establishes a "breakthrough device" designation process under Medicare and provides coverage under parts A and B for such devices during a 4-year transitional coverage period beginning on the date of designation, if furnished consistent with the device's Food and Drug Administration (FDA)-approved labeling for the indication granted priority review under FDA section 515B and the HHS Secretary determines, based on clinical data, that the device does not present an undue risk of harm outweighing clinical benefits for Medicare beneficiaries. (As background, Medicare generally excludes coverage for items and services not "reasonable and necessary" for diagnosis or treatment; breakthrough devices are novel medical devices prioritized by FDA for addressing unmet needs in life-threatening or irreversibly debilitating conditions, and this provision expedites Medicare access without a full national coverage determination during the transition period.) The section further (1) directs the Secretary, beginning 18 months after enactment, to designate qualifying devices (cleared, classified, or approved by FDA after enactment) within 6 months of a manufacturer's application if the device received FDA priority review, was cleared under FDA section 510(k) using clinical data (potentially including Medicare beneficiaries), would otherwise be covered absent the reasonable and necessary exclusion, and presents no undue risk; (2) requires an explanation for nondesignations identifying failed criteria; (3) mandates annual reports to Congress on applications received, designations made, and denials; and (4) authorizes Secretary review of aberrant billing patterns for such devices by providers or suppliers. This section also requires a final national coverage determination (or alternative coverage decision) for a breakthrough device before the end of its transitional coverage period if the request is submitted at least 9 months (or 12 months, for certain requests) prior.