Ensuring Patient Access to Critical Breakthrough Products Act

This bill would help Medicare patients get faster access to new, FDA-recognized “breakthrough” medical devices. It would require Medicare to temporarily cover these devices for up to four years after they receive breakthrough status, while Medicare gathers more information and makes a nationwide coverage decision. Coverage could be limited or stopped if the device is used outside its approved purpose or if data show the risks outweigh the benefits for Medicare patients .

Medicare would also be required to make a final national coverage decision before the end of that four-year window if a timely request is filed. The government could review unusual billing to prevent waste or fraud, and it would get extra funding to run this program. The process for granting “breakthrough” status to devices would begin 18 months after the law takes effect, and the four-year coverage clock would start when a device is officially designated as a breakthrough device .

• Who is affected: Medicare patients, device makers, and medical providers who use these devices.
• What changes: Four years of temporary Medicare coverage for breakthrough devices; faster national coverage decisions; safeguards against misuse or unsafe devices; and oversight of odd billing patterns .
• When: The breakthrough designation process starts 18 months after the law takes effect; the temporary coverage lasts four years from the date of designation. Congress would fund the work with $10 million per year from 2025–2030 .