“FDA has an established process to identify and give priority review to new breakthrough technologies for serious illnesses. Unfortunately, since there is no equivalent process at CMS, Medicare patients must often wait years to benefit from these breakthrough products due to frequent coverage and reimbursement delays.
“American patients deserve better, and the legislation introduced today by Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cardenas (D-Calif.), Gus Bilirakis (R-Fla.) and Terri Sewell (D-Ala.) will help ensure they get better.
“Under the legislation, for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA, CMS would provide immediate transitional coverage for three years. During the three-year coverage period, CMS would specify what additional data, if any, would be needed to continue coverage.
“In addition, the legislation would make improvements to CMS’s existing New Technology Add-on Payment (NTAP) program to reduce disincentives that limit prompt patient access to innovative technologies.
“Taken together, the breakthrough policy proposal and NTAP reforms would both stimulate development of important new devices and diagnostics and assure more rapid availability of those treatment options to patients.
“AdvaMed commends the bill’s sponsors for their leadership on this issue and for their commitment to ensuringpatients and physicians benefit from breakthrough medical technologies in a timely manner. We look forward to working with members of Congress, CMS and other key stakeholders to move this important legislation.”