Medicare beneficiaries would gain quicker access to breakthrough medical technologies under a new bipartisan bill sponsored by U.S. Rep. Jackie Walorski (R-IN).
“By streamlining the Medicare coverage process for new technologies, this commonsense legislation will boost American innovation and give Medicare patients faster access to life-saving medical devices,” the congresswoman said.
Medicare currently does not automatically cover cutting-edge medical products, even when the products are approved by the Food and Drug Administration (FDA). It can take up to three years for FDA-approved medical products to go through the Medicare coverage determination process, Rep. Walorski’s office explained.
To remedy this, Rep. Walorski on June 22 introduced the Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 4043, with sponsor U.S. Rep. Suzan DelBene (D-WA) and original cosponsor U.S. Rep. Fred Upton (R-MI). The legislation would require Medicare to temporarily cover all breakthrough products approved through the FDA for four years, speeding up vital treatments to millions of seniors.
“Seniors should not be waiting on new cures and therapies that could change or even save their lives,” Rep. DelBene said.
For medical technologies to receive the FDA’s breakthrough designation, they must provide more effective treatment of life-threatening diseases, have no approved alternatives, or be in the best interest of patients, according to a summary of the legislation.
“During my tenure, I have worked to expand access to cutting-edge treatments and medical technologies that can enhance quality of life and, in some cases, save lives,” Rep. Upton said. “The Ensuring Patient Access to Critical Breakthrough Products Act sends a clear message that both Republicans and Democrats can work hand in hand to help folks lead healthier, longer lives.”
Rep. Walorski’s proposal was included in the recent bipartisan Cures 2.0 Act discussion draft released by Reps. Upton and Diana DeGette (D-CO). The draft legislation aims to accelerate the development and delivery of innovative cures for a number of diseases.