Legislation to grant 4-year coverage of breakthrough medical devices passes Ways and Means, with a heavy discount
By Emma Beavins July 2, 2024 –
The House Ways and Means Committee advanced bipartisan legislation on Thursday that would grant Medicare coverage to novel medical technologies for four years while the Centers for Medicare & Medicaid Services (CMS) makes a national coverage determination.
The new version of the bill that was voted on by Ways and Means reduces the cost of the bill by 75% of the version that the House Energy and Commerce Committee voted favorably on back in November. It allocates $10 million per year over five years to CMS for the project.
The Ensuring Patient Access to Critical Breakthrough Products Act of 2024, if passed, would give any device designated as “breakthrough” from the Food and Drug Administration (FDA) four years of Medicare coverage. Co-sponsor of the bill Rep. Susan DelBene, R-Washington, said during the hearing that it takes CMS an average of more than five years to make a national coverage determination for FDA breakthrough devices.
DelBene said the size of the device manufacturing company is the only factor that has been linked to how fast CMS covers medical devices, not the amount of clinical data the device has.
