U.S. Rep. Charles Boustany (R-LA) launched legislation on Thursday that would eliminate downtime between when the FDA approves medical devices and when Medicare covers those devices.
The FDA’s Expedited Review Process often leads to delays in Medicare coverage for medical devices and technologies that have already gained approval. Boustany’s Breakthrough Pathways for New Medical Technologies Act, H.R. 5009, would establish a three-year period of automatic coverage of medical technologies immediately following FDA approval.
“As a surgeon, I know all too well how vital it is for patients and their doctors to have the most current and effective technology available,” Boustany said. “From diagnosing a simple cold to the early detection of a potentially fatal disease, we rely on the continued advancements in medicine to keep us at our best health. Delays in Medicare coverage of FDA-approved technologies present unnecessary financial uncertainty that can cripple medical research and development companies who are not only ensuring medical advancement continues, but are also creating high-paying American jobs. We must cut the red tape of Washington to ensure our physicians have access to the best technology available for our American families.”
Under the bill, medical technology would be reevaluated by Medicare for permanent approval after the three-year approval period ends, as well as gain private insurance coverage.
U.S. Rep. Gus Bilirakis (R-FL) said that the bill would help hundreds of medical device companies successfully develop innovative technologies.
“During a roundtable discussion in my district, I heard from these businesses and organizations on the barriers they face when developing new innovative technologies only to face non-coverage by (the Centers for Medicare and Medicaid Services),” Bilirakis said. “This bill works to address these issues to help them bring important devices and technologies to the many patients who need them. We must continue to encourage innovation, not stifle it. This legislation will streamline the payment process for effective new devices and ultimately help improve and save lives.”