Bilirakis Launches Breakthrough Bill

Congressman Gus Bilirakis (R-FL) launched legislation to ensure that patients have access to the most cutting edge treatments on the market, and to protect medical research and development companies, small and large, from bureaucratic delays.

As new devices and medical technologies go through the United States Food and Drug Administration's (FDA) Expedited Review Process, there is often a significant time delay for gaining coverage of the new technology under Medicare, following formal FDA approval. American families have come to rely on the persistent advances in new medical technologies that promise to improve their health and quality of life. Any delay in receiving Medicare coverage places financial barriers on research and development companies and proves to be detrimental to the well being to those in need of care.

"This legislation will help the 600 medical device companies in our state working to develop innovative and effective medical devices, as well as the millions of seniors on Medicare," said Congressman Bilirakis. "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 (CMS). 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."

Bipartisan co-sponsors of the legislation shared their support:

Congressman Charles Boustany Jr., MD (R-LA): "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. 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."

Congressman Richard Neal (D-MA): "Bringing critical cutting edge treatment and therapies to market is vital to helping patients lead healthy lives. By shortening the time it takes to bring to market lifesaving technologies, we are insuring better health outcomes for patients. Streamlining the approval process will also help our medical research innovators to continue to create jobs and spur future innovation. Massachusetts is home to some of highest concentration of research activity in the world and this legislation ensures that we remain at the forefront."

Rep. Tony Cardenas (D-CA): "I am proud to co-sponsor H.R.5009, as it would streamline Medicare coverage for approved technologies that go through the FDA's medical device review process. This would provide patients with timely access to life-saving innovations. It would also promote a more efficient regulatory ecosystem so that the roughly 1,700 medical device companies in California could continue to develop and innovate and spend more time taking care of customers in need."

H.R. 5009, Breakthrough Pathways for New Medical Technologies Act, directly addresses any lag in the FDA's approval-to-insurance coverage experience. This legislation allows for a three year automatic coverage of new medical technologies through the present Medicare New Technologies Add-on Payment (NTAP) process, following FDA Approval. Once the three year coverage has ended, the technology would then be re-evaluated by Medicare for permanent approval and would gain coverage by the private insurance industry.