California Life Sciences Association Expresses Strong Support for Legislation Increasing Patient Access to Medical Technologies

Newly introduced legislation bridges Medicare patient access gaps and modernizes policies to allow coverage of medical technologies approved through FDA’s expedited review process

WASHINGTON & SAN FRANCISCO & SAN DIEGO--(BUSINESS WIRE)-- California Life Sciences Association (CLSA), the trade association representing California’s innovative life sciences industry, announced its strong support for H.R. 5997, the Ensuring Patient Access to Critical Breakthrough Products Act of 2018. The bill introduced yesterday in the U.S. House of Representatives would provide Medicare coverage for technologies approved through the FDA’s medical device Expedited Review Process. This statement can be attributed to Sara Radcliffe, President & CEO, California Life Sciences Association:

“California Life Sciences Association (CLSA) strongly supports H.R. 5997 to ensure patients will have swift access to medical devices that have been determined by FDA to be considered ‘breakthrough’ technologies. Currently, many FDA-approved medical technologies experience a considerable multi-year delay in receiving coverage and payment determinations from the Centers for Medicare and Medicaid Services (CMS), creating access issues for patients in need. This bill is a common-sense solution to minimize any delays in patient access to products that have been determined by FDA to be innovative, breakthrough technologies.

“H.R. 5997 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. This important measure is a step in the right direction toward 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 1,800 medical device firms, sustaining 77,000 jobs in vibrant medical technology clusters like San Diego, the San Francisco Bay Area, Los Angeles, Orange County and other regions across the state. As the trade association representing California life sciences innovators, we endorse H.R. 5997 and thank Representatives Tony Cárdenas (D-San Fernando Valley), Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Gus Bilirakis (R-Fla.) and Terri Sewell (D-Ala.) for their leadership in introducing this common-sense legislation that will benefit patients nationwide for many years to come.”

Congressman Tony Cárdenas (D-San Fernando Valley), California’s 29th Congressional District added:

“I am pleased to help lead the charge in introducing this common-sense piece of legislation to increase patient access to medical technologies. The Ensuring Patient Access to Critical Breakthrough Products Act is vital for bridging Medicare patient access gaps and modernizing policies that foster coverage of medtech innovations approved as part of the FDA’s expedited review process. One of my main goals in Congress has always been to advance policies that foster innovation and bring better treatments to patients in need. Our federal government has an important role in supporting life sciences research and innovation. I’m proud to partner with, and have the support of the California Life Sciences Association for this important bill that will benefit patients nationwide for many years to come.”

Click here to urge Congress to support H.R. 5997, the Ensuring Patient Access to Critical Breakthrough Products Act of 2018.

  • Learn more about California’s life sciences industry
  • View CLSA’s Legislative Action Center
  • View upcoming CLSA events

About California Life Sciences Association (CLSA)

California Life Sciences Association (CLSA) is the state’s largest and most influential life sciences advocacy and business leadership organization. With offices in Sacramento, San Diego, South San Francisco, Los Angeles and Washington DC, CLSA works closely with industry, government, academia and others to shape public policy, improve access to innovative technologies and grow California’s life sciences economy. CLSA serves biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers throughout the Golden State. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged. Visit CLSA at, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.



California Life Sciences Association (CLSA)
Will Zasadny | Director, Communications | 619-961-8848


Source: California Life Sciences Association

Back to news