Ensuring Patient Access to Critical Breakthrough Products Act of 2016

Monday, June 6, 2016

Dear Representatives Boustany, Bilirakis, Cárdenas, and Neal:

As state and regional life sciences associations representing biotechnology, medical device companies, universities, research institutions, and venture capital firms across the country, all dedicated to developing and delivering life-enhancing and life-saving products, we write to express our strong support for your legislation, H.R. 5009, the Ensuring Patient Access to Critical Breakthrough Products Act of 2016.

The medical technology industry is an important and thriving sector in the U.S. economy, creating jobs in all 50 states and representing a sizable portion of the nation’s Gross Domestic Product. The industry is responsible for about 1.9 million jobs in the U.S. and an economic output of approximately $381 billion annually.

Access to state-of-the art medical technology and diagnostics can help to improve care and patient outcomes. However, there are significant regulatory and payment hurdles that delay patient access to needed life-saving treatment. A major hurdle is Medicare’s time-consuming and uncertain process of determining coverage and payment decisions for innovative medical technologies. These hurdles can exist for new “breakthrough” technologies, which are products that have the ability to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To qualify as “breakthrough”, these technologies must be in the best interest of patients, have no approved alternatives, or offer significant advantages over existing approved treatments. Unfortunately, Medicare’s current coverage and reimbursement mechanisms can take years for sponsors of new “breakthrough” technology to navigate.

H.R. 5009 would provide temporary transitional Medicare coverage for FDA approved or cleared breakthrough products, using an accelerated coding process. Removing delays and uncertainties from the process for coverage and reimbursement of products that truly represent significant clinical advances will be an important stimulus to investment in and development of these breakthrough diagnostics and treatments.

The bill would also make important changes to the New Technology Add-On Payment and outpatient pass-through programs. These improvements are designed to reduce coverage and payment disincentives that limit prompt patient access to innovative but more costly technologies.

We applaud your leadership and offer our support on this important legislation, Ensuring Patient Access to Critical Breakthrough Products Act of 2016. We look forward to working with you to ensure continued patient access to vital medical technology.

Arizona BioIndustry Association
Biomedical Engineering Alliance & Consortium (BEACON)
California Life Sciences Association (CLSA)
Colorado BioScience Association (CBSA)
Delaware Bioscience Association
Florida Medical Manufacturers Consortium (FMMC)
Georgia Bio
Healthcare Institute of New Jersey (HINJ)
Illinois Biotechnology Industry Organization (iBIO)
Indiana Medical Device Manufacturers Council, Inc.
Medical Alley Association
Massachusetts Medical Device Industry Council (MassMEDIC)
MedTech Association New York
Oregon Bioscience Association
Pennsylvania BIO
South Carolina Bio (SCBIO)
Southeastern Medical Device Association (SEMDA)
Texas Healthcare & Bioscience Institute (THBI)
Virginia Biotechnology Association

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