The Ensuring Patient Access to Critical Breakthrough Products Act, will help bridge a gap between FDA and CMS and improve patient access to breakthrough medical technologies for serious illnesses, S. 2998, to expedite CMS decision-making for innovative medical technologies.
The Ensuring Patient Access to Critical Breakthrough Products Act, as introduced, will help bridge a gap between FDA and CMS and improve patient access to breakthrough medical technologies for serious illnesses.
AdvaMed President and CEO
Scott Whitaker
“Currently, FDA has an established process to provide priority review to breakthrough technologies. We support reforms to that process in other pending legislation. However, there is no similar process at CMS to ensure patients have access to these devices and diagnostics in a timely manner” shared Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed). “So, after FDA determines a breakthrough technology is safe and effective, sometimes it is years later before patients have access to it because of coverage and reimbursement delays at CMS. Medicare beneficiaries deserve better.”
Sen. Dan Coats of Indiana introduced the legislation on May 26,2016 which will address this issue, allowing patients and physicians to benefit sooner from such breakthrough medical technologies. It has been assigned to the Senate Finance Committee.
Under the legislation, any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA would be provided immediate transitional coverage for three years by CMS. During the three-year period, the therapy would receive a predictable reimbursement, and CMS could specify what additional data, if any, would be needed to continue coverage after the three-year period.
In addition, the legislation would make improvements to CMS’s existing New Technology Add-on Payment (NTAP) program to reduce coverage and payment disincentives that limit prompt patient access to innovative technologies.
“These CMS reforms would both stimulate development of important new devices and diagnostics and assure more timely patient access to new treatment options. We look forward to working with members of Congress, CMS and other key stakeholders to move this legislation forward,” added Whitaker.