• iBIO is advocating for HR1651, the Ensuring Patient Access to Critical Breakthrough Products Act, to provide seniors with quicker access to life-saving medical technologies.
• This bipartisan legislation seeks to create a 4-year automatic coverage period for FDA-approved breakthrough devices, providing more autonomy to CMS when evaluating these technologies.
• iBIO is concerned about CMS’s current Translational Coverage for Emerging Technologies guidance and its ability to evaluate and cover all innovative technologies effectively.
• Congressman LaHood has signed on as a co-sponsor of HR1651, and iBIO is pushing other Illinois lawmakers to support this critical legislation.
As a leading advocate for the life sciences industry in Illinois, the Illinois Biotechnology Innovation Organization (iBIO) is working tirelessly to promote HR1651, the Ensuring Patient Access to Critical Breakthrough Products Act. This bipartisan legislation would guarantee seniors access to life-changing medical technologies, ensuring they receive the latest and most effective treatments available.
Medical technology is rapidly advancing, leading to innovative solutions for diagnosing, preventing, and treating illnesses. However, while our country’s medical technology companies are experiencing exponential growth, Medicare coverage policies often create significant hurdles for breakthrough products, leaving many Americans without access to the latest medical technologies.
To address this issue, HR1651 would establish a four-year automatic coverage period for FDA-approved breakthrough devices, providing seniors quicker access to life-saving medical technologies. Additionally, the legislation creates a roadmap for collection of further evidence on the benefits of these devices, which CMS could use to make a permanent coverage decision after the initial four-year period. Overall, the bill would provide more autonomy to CMS to evaluate breakthrough technologies while expanding access to critical treatments.
iBIO is concerned about the limitations of the CMS’s Translational Coverage for Emerging Technologies (TCET) guidance, which does not create a dedicated pathway for these technologies and excludes diagnostic tests and devices without benefit categories. Additionally, there are concerns about CMS’s ability to evaluate and cover all innovative technologies that may want to access this coverage pathway given its limited resources. HR1651 would eliminate these concerns, ensuring adequate resources and timely policy decisions on coverage policies that affect the well-being of Medicare beneficiaries.
We are proud to see that Congressman LaHood has signed on to HR1651 as a co-sponsor, and we urge other lawmakers in Illinois to support this important legislation. Expediting access to breakthrough medical technologies for seniors is critical in improving health outcomes and enhancing quality of life for many Americans. iBIO is committed to working in DC to ensure that every patient has the opportunity to access new and innovative treatments that can help them live longer and healthier lives.