An Overview of TEC and Staff Biosketches

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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.
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