Legislation Introduced to Speed CMS Coverage of FDA Approved Devices

Novel medical devices declared safe and effective by the FDA can take up to three years before receiving Centers for Medicare and Medicaid (CMS) coverage and reimbursement. That’s a long time for elderly Medicare patients to wait for potential life-saving medical care.

The U.S. Senator from the “Orthopedic Capitol of the World” wants to change that.

On May 26, 2016, Indiana Republican Senator Dan Coats, a member of the Senate Finance Committee, introduced The Ensuring Patient Access to Critical Breakthrough Products Act. The legislation would establish a program to accelerate transitional coverage and payment for new technologies that offer breakthroughs for serious illnesses affecting Medicare beneficiaries. During the three-year period of the program, the therapy would obtain predictable reimbursement coverage, and CMS could specify what supplemental data (if any) would be required to continue coverage after the three-year period.

Currently, a new technology may pass the FDA’s expedited review program, but can then face the up to three-year process of navigating the coverage and reimbursement process established by CMS. Years pass before Medicare beneficiaries are able to access these approved medical breakthroughs. “These regulations also create a financial uncertainty that disincentivizes investment in new, groundbreaking research. The Coats legislation would make improvements to the outdated new technology add-on payment (NTAP) program, so barriers that limit patient access to valuable technologies would be removed, ” stated a press release from the Senator’s office.

“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, ” said Coats. “This legislation would streamline the current process, allowing Medicare patients to receive new treatments while also ensuring proper safety and quality regulations are met.”