Legislation to grant 4-year coverage of breakthrough medical devices passes Ways and Means, with a heavy discount

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. 

The time lag between FDA clearance and CMS coverage leaves Medicare beneficiaries without insurance coverage and forces them to pay out of pocket for novel screening, diagnostic tests and other medical devices. In the interim, most commercial payers tend to make coverage determinations on the devices—so private insurance holders can already access them. 

The bill tries to ensure there is a final answer on a national coverage determination before the end of the transitional coverage period. It currently has 86 co-sponsors, DelBene said. 

The new version of the bill also includes stronger safety standards for FDA breakthrough devices, like mandating the devices have clinical trial information on the Medicare population. 

Democratic representatives Lloyd Doggett, Texas, and Bill Pascrell, New Jersey, argued against the passage of the bill, citing patient safety risks that have historically stemmed from FDA breakthrough devices. Doggett said thoracic and neurological surgeons have also expressed concern about using “untested” medical devices on Medicare beneficiaries.

The bill passed out of committee with a vote of 36 to 5. 

The Biden administration has a final rule forthcoming on transitional coverage for emerging technologies (TCET). The proposed version of TCET narrowed the scope of the temporary coverage project down to just six devices per year, which critics say is too few.

Others in the digital therapeutics camp are pushing the administration to make the temporary coverage available to technologies that don’t currently have a Medicare benefit category.