Blue Shield of California Foundation and California HealthCare Foundation Launch Center for Medical Technology Policy.

SAN FRANCISCO -- Nation's First Center to Study Real-World Effectiveness of Emerging Medical Technologies to Be Managed by Nonprofit Health Technology Center

The Blue Shield of California Foundation (BSCF) and the California HealthCare Foundation (CHCF) are jointly funding start-up of the nation's first center where health care decision makers, stakeholders, and experts can work together in a neutral forum to design real-world studies on emerging medical technologies, according to the nonprofit Health Technology Center (HealthTech), which is managing the effort.

The Center for Medical Technology Policy (CMTP) will develop research projects that provide health care decision-makers with new evidence on the real-world effectiveness and safety of innovative technologies, such as new surgical procedures, medical devices, diagnostics or biopharmaceuticals.

"The CMTP will go beyond technology assessment efforts that rely primarily on reviews of existing clinical trial information," said Molly Coye, M.D., founder and CEO of HealthTech. "Evidence-based information and policy options generated by the Center could save the health care system millions of dollars annually -- funds that are currently wasted on adoption or excessive use of the latest 'hot' technologies. The Center's studies will help us learn which technologies actually provide little or no relative benefit beyond today's effective and less-expensive established procedures."

A $495,000 CHCF grant in January 2006 got the CMTP up and running and is being used to identify the Center's first two studies of emerging technologies where there are systematic gaps in the evidence to support widespread clinical adoption.

In July 2006, a $410,000 BSCF grant strengthened the capabilities of the CMTP. The new funds will help it foster communication and coordination between different evidence-based medicine initiatives across the country, convene advisory committees of patients and clinicians, and collaborate with the California Technology Assessment Forum (CTAF) to design an additional study of a promising technology.

"There has been an increasing consensus on the need to expand the capacity to identify critical questions about new technologies from the perspective of the health care decision makers and the need to develop strategies to conduct these studies quickly and affordably," said Sean Tunis, MD, MSc, the founder and director of the CMTP. "Our hope is that by developing a collaborative approach to the design and execution of these studies, decision makers will have the information necessary to more rapidly adopt high value technologies and more rapidly abandon those of little or no value."

Specific examples of technologies that may be studied by the CMTP include tele-ICU, intensity modulated radiation therapy, and minimally invasive bariatric surgery. Bariatric surgery has experienced an eight-fold increase between 1998 and 2003, while undergoing limited evaluation of safety and long-term health outcomes. Each study will be developed through workgroups that include patients, clinicians, payers, product developers, methodologists, and other experts as necessary.

The CMTP is the first private organization to directly address the critical knowledge gaps commonly identified in systematic reviews by such organizations as the Agency for Healthcare Research and Quality, clinical practice guidelines from medical professional organizations, and technology assessments conducted by many large health plans.

These groups and others point out that clinical research in the U.S. typically involves only two "pillars" -- the medical product industry focused on product development and obtaining FDA approval and the National Institutes of Health (NIH) with a primary focus on discovery and the initial demonstration of clinical efficacy. By developing a model for a "third research pillar" -- focused on the real-world questions asked by health care decision makers, the CMTP intends to address:

--Comparative effectiveness of new technologies against current standards of care 

--Studies of procedures or technologies not regulated by the FDA (such as surgical procedures and some pharmacogenomic tests)

--Outcomes not typically measured in regulatory trials, such as quality of life and health care utilization

--Drug/device complication rates/side effects in real world settings

--Risks/benefits of common off-label uses

--Risks/benefits to important patient subgroups or those excluded from trials

During the CMTP's first year of operation it will establish a broad-based steering group of health care decision makers; develop partnerships with related initiatives such as the Institute of Medicine's Roundtable on Evidence-Based Medicine, the new Institute for Clinical and Economic Review (ICER) at Harvard Medical School, the New England Healthcare Institute, and the Integrated Healthcare Association; and select and design pilot studies for three promising emerging technologies. For more information about the CMTP, visit www.cmtpnet.org.

About HealthTech

HealthTech is a nonprofit research and education organization that develops objective forecasts, innovative decision-making tools, and facilitates a learning network of experts for the benefit of healthcare systems, hospitals, safety-net providers, government agencies, and others facing critical decisions on emerging healthcare technologies. For more information, visit www.healthtech.org.

About California Healthcare Foundation

Based in Oakland, the California HealthCare Foundation (CHCF) is an independent philanthropy committed to improving California's health care delivery and financing systems. For more information, visit www.chcf.org.

About Blue Shield of California Foundation

The Blue Shield of California Foundation is one of the largest health care grant-making organizations in California, awarding $30 million last year. The foundation was formed by Blue Shield of California, a not-for-profit corporation with more than 3.2 million members, 4,300 employees and 20 offices throughout California. For more information, visit www.blueshieldcafoundation.org.