US Senate introduces legislation to streamline Medicare beneficiary access to breakthrough devices



A new bill introduced to the US Senate by Senator Dan Coats seeks to address the gap between the US Food and Drug Administration (FDA)’s priority review process for breakthrough medical devices, and the Centers for Medical and Medicare Services’ (CMS) review system for reimbursement.

Presently, the established FDA regulatory process can prioritise those new treatments which may offer breakthroughs for those patients who have serious conditions but limited treatment options. The CMS, however, does not have a parallel review process, leaving Medicare beneficiaries unable to access potential breakthrough treatment. Patients can wait up to three years to receive breakthrough treatments while applications are choked by coverage and reimbursement delays.

Coats’ legistlation, “Ensuring Patient Access to Critical Breakthrough Product Act”, aims to install a system of immediate payment and transitional coverage for FDA-endorsed novel medical technologies, for up to three years. Medicare beneficiaries should be able to expect predictable reimbursement coverage for this period, whilst the CMS can issue requests for supplemental data before the immediate three-year coverage period is up.

It is hoped that this legislation will help to remove barriers to patient access of breakthrough medical devices. Rapid market access should also aid the development of novel medical devices.