An Overview of BCBSA TEC BCBSA TEC organization and management structure provides stability and flexibility uniquely suited to sustain and expand capacity for research on effective healthcare. BCBSA TEC encompasses both the Technology Assessment program, which supports BCBS Plans and other healthcare decision makers, and the AHRQ Evidence-based Practice Center. Each is separately funded and adheres to strict policies of confidentiality regarding work in progress. Almost all BCBSA TEC personnel are full-time employees. Thus, the synergy between the Technology Assessment program and the EPC supports a seasoned interdisciplinary professional staff that can move easily across projects. In contrast to most academic medical centers, EPC Director, Naomi Aronson, PhD, has management control over all personnel, permitting resource loading at critical junctures. The Blue Cross and Blue Shield System is the largest health insurer in the U.S., with 100 million beneficiaries. The System is a federation of 39 independent BCBS Plans that are represented and licensed by the Blue Cross and Blue Shield Association. BCBSA TEC was established in 1985 and is housed within BCBSA’s Office of Clinical Affairs (OCA). Led by BCBSA Chief Medical Officer, Allan Korn, MD, FACP, OCA promotes collaborations with public and private healthcare organizations; brings clinical expertise to public policy issues; and promotes the use of evidence-based medicine in clinical care. In addition to TEC, OCA houses the Blue Distinction Centers for specialty care. Blue Distinction® is a designation awarded to medical facilities that meet evidence-based selection criteria for delivering quality healthcare. OCA Blue Distinction Center staff collaborate with leading medical specialists and societies to develop the selection criteria. Thus, BCBSA TEC’s ample access to clinical experts and stakeholders is supplemented by OCA’s relationship-building activities. Founded in 1985 by the Blue Cross and Blue Shield Association (BCBSA), the Technology Evaluation Center (TEC) pioneered the development of scientific criteria for assessing medical technologies through comprehensive reviews of clinical evidence. Since its inception, TEC has been recognized nationally for leadership in producing evidence-based technology assessments. TEC Assessments provide objective information to those who deliver and manage medical care. They are based on clinical and scientific evidence and evaluate whether a technology improves health outcomes, such as length of life, quality of life and ability to function. TEC Assessments are not recommendations for coverage decisions by health insurance companies. Findings of the TEC Assessments are provided to all independent Blue Cross and Blue Shield Member Plans. A 3-year rolling inventory of TEC Assessments is available publicly at the TEC Internet resource, www.bcbs.com/tec. In 1997, TEC was designated as one of 12 original Evidence-based Practice Centers (EPCs) for the federal Agency for Healthcare Research and Quality (AHRQ). TEC was first awarded a 5-year contract renewal in 2002 and another in 2007 and now serves as one of 14 current EPCs. The findings of the EPCs provide the foundation on which organizations - such as physician specialty societies - develop clinical practice guidelines, as well as tools and strategies for improving the quality of healthcare services. The TEC's EPC has provided thirteen evidence reports to AHRQ; most can be viewed on the AHRQ Web site (www.ahrq.gov) or AHRQ's Effective Health Care Program site (http://effectivehealthcare.ahrq.gov). The Blue Cross and Blue Shield Association is a national federation of 39 independent, community-based and locally operated Blue Cross and Blue Shield companies, that collectively provide healthcare coverage for 100 million – one in three – Americans. The Association is headquartered in Chicago, with offices in Washington, D.C. Biosketches of senior TEC Staff Edgar R. Black, MD, joined BCBSA TEC in 2006 as Medical Director of the Medical Policy Reference Manual. Dr. Black has written and overseen the development and updating of hundreds of medical policies, which span the clinical spectrum from primary care to subspecialized medicine. Prior to joining BCBSA TEC, Dr. Black was Regional Vice President and Chief Medical Officer of Excellus BlueCross BlueShield, Rochester Region. Dr. Black served on the Rochester Community Technology Assessment Advisory Board (CTAAB), which monitored diffusion of new medical technology in the Rochester, NY, region. Dr. Black also played a pivotal role in developing and disseminating a single set of evidence-based guidelines for both preventive care and common diseases used by providers and payors. Dr. Black was lead editor and author for Diagnostic Strategies for Common Medical Problems, 2nd Edition. Heather M. Brown, MD, joined BCBSA TEC in March 2008. She is a board-certified pathologist with subspecialty boards in cytopathology and a fellowship in oncologic surgical pathology; her subspecialty training was at M.D. Anderson Cancer Center and the University of Florida and some special interests include breast cancer and head and neck pathology. Dr. Brown was part of the research team on the AHRQ CER of radiotherapy techniques for head and neck cancer and is lead investigator on our current topic refinement, hematopoietic stem-cell transplant in pediatric patients (to be subsequently developed as a CER). At BCBSA TEC, she developed one of the first technology assessments of KRAS mutation testing in colorectal cancer, used to support the American Society for Clinical Oncology’s (ASCO) clinical guidelines development process. She also researched medical reference policy topics in high-dose chemotherapy and oncology. Mark D. Grant, MD, MPH, joined BCBSA TEC in 2005. He is lead investigator on the update of our AHRQ CER on erythropoietic stimulants in the treatment of the anemia of cancer therapy; he was also co-investigator of an EPC report on osteoarthritis of the knee. He is leading the cost-effectiveness analysis component of our AHRQ technology assessment of bone morphogenetic protein for CMS. Dr. Grant is a member of MEDCAC and has been on panels regarding use of information from genetic testing, stroke outcomes, and evidentiary priorities. Dr. Grant’s BCBSA TEC Assessments have addressed carotid angioplasty and stenting, cardiac diagnostic technologies, artificial cervical disc replacement, predictive genetic testing, and measurement of chronic pain outcomes. He taught an advanced statistics workshop for the CMS Coverage and Analysis Group; and taught epidemiology at the University of Illinois and the University of Chicago. He is currently pursuing a doctorate in epidemiology. He is also a statistical reviewer for the Journal of the American Medical Association. Steven Gutman, MD, MBA, will join BCBSA TEC in January 2010 as a full-time employee. Currently Professor of Pathology, University of Central Florida, College of Medicine, Dr. Gutman has 17 years’ experience with the FDA Center for Devices and Radiological Health (CDRH). As founder and Director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Dr. Gutman was responsible for all premarket, compliance, and postmarket regulatory activities for in vitro diagnostic devices. Dr. Gutman also was involved in approval of novel tests for cancer drug-diagnostic companion use, including HER2 neu and Herceptin®, EGFR and Erbitux®, and c-Kit and Gleevec®. He was the lead scientist at CDRH for addressing policy related to emerging infectious diseases and diagnostics for both environmental monitoring and patient diagnosis for biothreat agents. He was a member of the Secretary’s Advisory Committee on Genomics, Health, and Society (SACGHS). Frank Lefevre, MD, has been with BCBSA TEC since 1991. He is board certified in internal medicine and has more than 18 years’ expertise in technology assessment, primary care internal medicine, and medical education. BCBSA TEC contracts with Northwestern University for 60 percent of Dr. Lefevre’s time. Dr. Lefevre will lead the update of the AHRQ CMS technology assessment on spinal fusion in spring of 2010. He was the lead investigator on the EPC asthma report that supported a National Heart, Lung, and Blood Institute update of treatment guidelines, and was co-investigator on two additional EPC reports. He has authored more than 60 TEC Assessments, primarily in the areas of internal medicine and cardiology (e.g., genetic testing for hypertrophic cardiomyopathy and long QT syndrome, computer-assisted navigation for total knee arthroplasty). He has conducted workshops on systematic review for CMS staff. David H. Mark, MD, MPH, joined BCBSA TEC in 1999. He was co-investigator on two EPC reports (asthma and endoscopic retrograde cholangiopancreatography). He also was lead investigator on AHRQ CMS technology assessments of vertebroplasty and kyphoplasty. He recently completed a BCBSA TEC Assessment and critical appraisal of cost effectiveness analyses on CT colonography for colon cancer screening. He taught a statistics workshop for CMS staff. He has written more than 30 TEC Assessments on various topics, with emphasis on medical devices (e.g., transcranial magnetic stimulation for depression, artificial vertebral discs), screening, and diagnostic tests. He is a contributing editor at JAMA, specializing in statistics, epidemiology, and decision analysis. He was formerly Director of Research in the Department of Family Medicine at the Medical College of Wisconsin. Margaret Piper, PhD, MPH, joined BCBSA TEC in 1994. Dr. Piper was the lead investigator for one AHRQ EPC evidence report and co-investigator on four others, including the 2006 CER of epoetin and darbepoetin. She has authored more than 30 BCBSA TEC Assessments, primarily in the areas of autoimmunity and transplantation, oncology, laboratory medicine, and genetic testing. She has authored BCBSA TEC Assessments on gene expression profiling in breast cancer; genetics of prostate cancer; colon cancer screening; prophylactic mastectomy; pharmacogenomics of tamoxifen response; and pharmacogenomic testing to manage fluorouracil toxicity. Dr. Piper is a member of the CDC’s Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Dr. Piper’s prior experience includes clinical diagnostic laboratory management and design and evaluation of new laboratory diagnostics. Following an NCI fellowship in cancer prevention and control, she conducted research in cancer epidemiology at NCI and CDC. Dr. Piper has a BS in molecular biology, a PhD in immunology, and an MPH in epidemiology. Thomas A. Ratko, PhD, joined BCBSA TEC in 2005. Dr. Ratko has been a coinvestigator on two AHRQ reports: a CER on radiotherapy techniques in head and neck cancer and an evidence report on treatment of primary and secondary osteoarthritis of the knee. He is currently lead investigator on an AHRQ technology assessment of bone morphogenetic protein for CMS and contributor to AHRQ topic refinement on hematopoietic stem-cell transplantation in pediatric patients. He has authored TEC Assessments on metal-on-metal total hip resurfacing, and artificial intervertebral disc for the cervical spine. Dr. Ratko also authors medical reference policies on oncology topics. Prior to BCBSA TEC, Dr. Ratko was Manager, Technology Assessment, for the University HealthSystem Consortium (UHC). Previous to UHC, Dr. Ratko was a Senior Scientist in the Department of Immunology and Infectious Diseases at the American Medical Association (AMA). His research and technology assessment experience includes hematology, immunology, and oncology. Barbara Mauger Rothenberg, PhD, joined BCBSA TEC in 2005. She has been coinvestigator on two AHRQ EPC projects: HER2 testing to manage patients with breast or other solid tumors and the CER on radiotherapy techniques for treating head and neck cancer. She has written BCBSA TEC Assessments in the areas of breast imaging and cancer treatment, and a special report on radiation risks from diagnostic imaging. Recent reports include accelerated partial breast radiation as sole radiotherapy after breastconserving surgery; off-label use of bevacizumab for advanced adenocarcinoma of the pancreas, computer-aided detection with full field digital mammography; and use of a breast lymph node assay to detect sentinel node metastases. Before joining BCBSA TEC, Dr. Rothenberg was a member of BCBSA’s Research Group. This work included analyzing large claims databases understanding trends in diagnostic imaging use. Prior to working at BCBSA, Dr. Rothenberg was Health Policy Director for Excellus BlueCross BlueShield in Rochester, NY, and Director of Quality Assessment for the Rochester Health Commission. EPC Associate Director, David Samson, MS, joined BCBSA TEC in 1987 and has been the EPC Associate Director under EPC III. Mr. Samson has more than 20 years’ experience in evidence-based analysis across a wide range of medical technologies. He was lead investigator on three AHRQ evidence reports (wound-healing technologies, knee osteoarthritis, comparative effectiveness of radiotherapies for head and neck cancers), one AHRQ Technology Assessment (positron emission tomography on breast cancer), and has been co-investigator on another three AHRQ reports, all cancer related (androgen suppression in advanced prostate cancer; management of small cell lung cancer; and HER2 testing for breast and other solid tumors). Mr. Samson has written more than 100 BCBSA TEC Assessments or reference medical policies. Mr. Samson’s areas of expertise include research methods, decision analysis, diagnostics, and oncology. He has taught statistics workshops at CMS and was a section lead (“scoping” section) for the AHRQ Methods Manual chapter on diagnostic tests. He was a member of the MEDCAC Panel on computed tomographic colonography as a colorectal cancer screening tool. He has served on the American College of Chest Physicians guideline panel on small cell lung cancer and on several panels with the American Society of Clinical Oncology. At present, Mr. Samson is pursuing a PhD in epidemiology with a concentration in chronic diseases at the University at Albany. Suzanne Stratton, Ph.D. Dr. Stratton is an Associate Director of TEC; she joined the program in January 2010. She was previously Vice President for Research at the Carle Foundation Hospital, the primary teaching hospital for the University of Illinois College of Medicine at Urbana Champaign. Prior to that, she was a Project Manager, Department of Clinical Trials for Vical, Inc. where she was responsible for the implementation and management for all aspects of operations of phase I and phase II, multicenter cancer clinical trials. She also served as a Project Manager for Product Development at Scantibodies Laboratory, Inc., where she was accountable for research and development of investigative diagnostic devices. In addition to serving as adjunct faculty her academic appointments include Director and Principal Investigator, Prostate Cancer Prevention Program and Research Specialist, Principal, Cancer Prevention and Control at the University of Arizona. Dr. Stratton also was a member of the University’s Institutional Review Board for many years and has served as a reviewer for a number of peerreviewed journals as well as many Department of Defense study sections. She has coauthored a long list of publications. She has a B.S. degree in Biological Sciences from the University of California, Irvine and a Ph.D., Cancer Biology Program from the University of Arizona.