CLSA Applauds Efforts to Increase Patient Access to Breakthrough Medical Technologies

H.R. 5009 bridges Medicare patient access gaps and modernizes policies to allow coverage of technologies approved through FDA’s expedited review process

Washington, DC (April 21, 2016) – California Life Sciences Association (CLSA), the statewide public policy organization representing over 750 of California’s leading life science innovators, lauded the introduction of H.R. 5009, legislation introduced yesterday that would streamline Medicare coverage for technologies approved through the FDA’s medical device expedited review process. The following statement may be attributed to Todd Gillenwater, CLSA’s Executive Vice President of Advocacy & External Relations:

“California Life Sciences Association (CLSA) strongly supports H.R. 5009 to modernize Medicare coverage and payment policies for qualifying medical devices, ultimately improving timely patient access to innovative, breakthrough technologies.

“Currently, many FDA-approved medical technologies experience a considerable delay in receiving coverage and payment determinations from the Centers for Medicare and Medicaid Services (CMS), creating access issues for patients in need. H.R. 5009 is critical in bridging gaps in the medical technology innovation ecosystem, ensuring that efficient regulatory processes at FDA are coupled with timely and appropriate coverage and payment determinations at CMS, thereby promoting continued medical device research and development and, most important, advancing and protecting patient access to these life-saving and life-sustaining treatments.

“California is home to nearly 1,700 medical device companies, providing approximately 75,000 jobs in vibrant medical technology clusters up and down the state. As the voice of California’s life sciences innovators, we applaud the leadership of Reps. Tony Cárdenas, Charles Boustany, Richard Neal and Gus Bilirakis for introducing H.R. 5009, and look forward to working with them to advance this common-sense legislation that will benefit patients nationwide for many years to come.”

Click here to view the legislation

About California Life Sciences Association (CLSA)
California Life Sciences Association (CLSA) is the leading voice for California’s life sciences sector. We work closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions and grow California’s life sciences innovation ecosystem. CLSA serves over 750 biotechnology, pharmaceutical, medical device, and diagnostics companies, research universities and institutes, investors and service providers. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged to create the state’s most influential life sciences advocacy and business leadership organization. Visit CLSA at, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

Media Contact:
Will Zasadny
Associate Director, Communications for CLSA