Devicemakers would see new devices or diagnostics designated as breakthrough technologies receive immediate coverage by the Centers for Medicare & Medicaid Services for three years under new legislation introduced in Congress.
Currently, Medicare does not automatically cover the latest advances in medical technology. The lag between FDA approval and Medicare’s coverage determination can take up to three years.
The Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 5997) would require Medicare to cover all breakthrough products that are approved through the FDA’s expedited review process for three years. Within those three years Medicare must make a permanent coverage determination.