Senate bill looks to streamline CMS pathway for “breakthrough” devices

The U.S. Senate has introduced a bill to expedite Centers for Medicare and Medicaid Services decision making for new medical devices.

The bill, titled the “Ensuring Patient Access to Critical Breakthrough Product Act” will help “bridge a gap” between the FDA and CMS and “improve patient access to breakthrough medical technologies,” according to a new report from medical device industry group Advamed.

“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. 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,” Advamed CEO Scott Whitaker said in a press release.

The bill was introduced by Sen. Dan Coats (R-Ind.), with the goal of establishing a program to accelerating transitional coverage and payment for new technologies that “offer breakthroughs for serious illnesses affecting medicare beneficiaries.”

“Researchers and entrepreneurs, including many in Indiana, regularly come up with groundbreaking new treatments for some of our worst illnesses, only to encounter government regulations that prevent many patients from receiving potentially life-saving care. This legislation would streamline the current process, allowing Medicare patients to receive new treatments while also ensuring proper safety and quality regulations are met,” Coats said in prepared remarks.

Through the legislation, new devices or diagnostics designated as a “breakthrough technology” and deemed safe and effective by the FDA would receive transitional coverage for 3 years by CMS.

Currently, FDA-cleared devices can receive expedited reviews but will still face up to 3 years to receive reimbursement and coverage from CMS, Coats said. The new bill would make “improvements to the outdated new technology add-on payment program” to remove barriers from patient adoption.

“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,” Whitaker said in a prepared release. “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.”

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