Creates a temporary Medicare coverage pathway so FDA-designated “breakthrough” medical devices can get Medicare payment during a national coverage decision process. The law requires the Secretary to decide designation requests within 6 months, gives a 4‑year transitional coverage period after designation, mandates annual reports to Congress, and provides $10 million per year (FY2026–FY2031) to CMS to implement the changes.

The measure defines the breakthrough designation criteria and adds the designation process, reporting requirements, and the appropriations authority to the Social Security Act to support CMS operations during implementation.