Ensuring Patient Access to Critical Breakthrough Products Act
The Ensuring Patient Access to Critical Breakthrough Products Act aims to speed Medicare coverage for FDA-designated “breakthrough devices.” It creates a new framework under which certain breakthrough devices can receive a transitional Medicare coverage period of four years after designation, and it establishes a formal designation process, criteria, and reporting to Congress. The bill also requires expedited national coverage determinations (NCDs) during the transition and adds funding for CMS to administer these changes. In short, the bill seeks to reduce delays in Medicare coverage for breakthrough medical devices by creating a formal designation process, a temporary coverage period, and faster decision-making requirements, with protections to ensure safety and proper use. Key elements include: (1) a new designation process for breakthrough devices by the Secretary (18 months after enactment) based on defined criteria; (2) a four-year transitional coverage period during which designated breakthrough devices may be covered under Medicare; (3) conditions tied to FDA labeling and priority review for coverage during transition, plus an undue risk standard; (4) a requirement that final Medicare coverage decisions (NCDs) for breakthrough devices be issued before the end of the transition if timely, with specific timing rules; (5) annual reporting to Congress on designations, coverage, and denials; (6) authority to review aberrant billing patterns; and (7) dedicated funding for CMS to implement these changes ($10 million annually from FY2025–2030).
Key Points
- 1Establishment of a formal designation process for breakthrough devices (-section 1899D). Beginning 18 months after enactment, manufacturers can apply for designation if the device meets criteria including priority review, clinical data supporting FDA clearance based on data from trials that include Medicare beneficiaries, and potential for coverage under Part A or B without the usual prerequisites; designation is determined within six months, with an explanation if not designated.
- 2Definition of “Breakthrough Device” and “Transitional Coverage Period.” A breakthrough device is designated by the Secretary under FDA rules and is covered during a four-year transitional period starting from designation. The period is defined to align with FDA labeling for the indicated use and the device’s priority review status.
- 3Conditions for transitional coverage during the four-year period. Coverage applies for devices furnished during the transitional period that are used in accordance with FDA labeling for the indicated indication and priority review, or that the Secretary determines, based on clinical data, present an undue risk that outweighs benefits. (This sets guardrails to ensure patient safety during the transition.)
- 4Expedited final Medicare coverage decisions during the transition. For national coverage determinations (NCDs) related to breakthrough devices, the Secretary must issue a final decision or determine coverage before the end of the transitional period if timely coverage requests were filed within specified windows (9 months or 12 months before the period’s end, depending on the case).
- 5Annual reporting to Congress. The Secretary must report each year on the number of designation applications, the number of devices designated, and the number of applications denied for not meeting criteria.
- 6Review of aberrant billing. The Secretary may review devices that show aberrant or outlier billing patterns to assess medical necessity and reasonableness.
- 7New funding for implementation. The bill provides $10 million per year (FY 2025–2030) to CMS’s Program Management Account to support these amendments, in addition to existing funds.