Medical Device & Diagnostics Forum

May 20-24, 2006
Marriott Philadelphia, Philadelphia, PA


ISPOR has launched an initiative to address methodological issues and good research practices when conducting outcomes research for medical devices and diagnostics. The product of this initiative is a book titled: Medical Device & Diagnostics Outcomes Research: Issues & Good Research Practices. This book will address issues related to current health technology assessment methodologies and recommend good outcomes research practices that are specifically "tailored" for fast-paced, medical device and diagnostics technology environment. This initiative is a joint project of the ISPOR US Medical Device & Diagnostics Council and the ISPOR European Medical Device & Diagnostics Council with input from the Asia-Pacific Medical Device & Diagnostics Council.

Moderators: Stephen Hull, Chair, US ISPOR Medical Device & Diagnostics Council, and Vice President, Business Development, Vice President, Global Strategy and Analysis, Advanced Medical Technology Association, Washington, DC, USA, and Stacey Ackerman MSE, PhD, Medical Device & Diagnostics Outcomes Research: Issues & Good Research Practices Co-editor & Vice President, Covance Health Economics & Outcomes Services, San Diego, CA, USA

Research Differentiation & Evidence Hierarchy
Speaker: Randel Richner MPH, Medical Device & Diagnostics Outcomes Research: Issues & Good Research Practices Chapter Author & VP of Government Affairs, Boston Scientific, Boston, MA, USA

Clinical Outcomes
Speaker: David Polly MD, Medical Device & Diagnostics Outcomes Research: Issues & Good Research Practice Section Editor & Professor and Chief of Spine Surgery, Department of Orthopedic Surgery, University of Minnesota, Minneapolis, MN, USA

Economic Outcomes
Speaker: Seema Sonnad, PhD, Medical Device & Diagnostics Outcomes Research: Issues & Good Research Practice Section Editor & Associate Professor, Dept of Surgery, University of Pennsylvania, Philadelphia, PA USA

Patient Reported Outcomes
Speaker: Susan Mathias MPH, Medical Device & Diagnostics Outcomes Research: Issues & Good Research Practice Chapter Author & Vice President, Ovation Research Group, San Francisco, CA USA


Medical Device & Diagnostics Forum

May 17, 2005
Marriott Wardman Park, Washington, DC, USA

Moderator: Stephen Hull, Vice President, Global Strategy and Analysis Department, Advanced medical Technology Association, Washington, DC, USA

FDA Perspective: What Is the FDA’s Experience with Post Approval Device Studies? What Is the Primary Evidentiary Role of These Studies?
Speaker: Neal Muni MD, MSPH, Medical Officer, US Food and Drug Administration, Rockville, MD, USA
The usefulness of post market studies for medical devices, including a view on time, cost and application of the evidence, will be presented.

CMS Perspective: What Is CMS's View On The Role of Postmarket Evidence in Coverage for Medical Device?
Speaker: Steven Phurrough MD, MPA, Director, Coverage and Analysis Group, Office of Clinical Standards & Quality Center for Medicare and Medicaid Services, Baltimore, MD, USA
The role of post-market evidence in coverage for medical devices from the perspective of the Center for Medicaid and Medicare, Department of Health and Human Services will be presented.

What Are the Limitations of Post-Market Studies? In What Conditions Are They Best Applied? Practical Realities of Postmarket Research?
Speaker: Clifford Goodman PhD, Vice President, The Lewin Group, Falls Church, VA, USA
The practical realities of post-market research will be presented.

Panel Discussion


Medical Device & Diagnostics Forum

May 18, 2004
Crystal Gateway Marriot, Arlington, VA, USA


Introduction to the Issue – Common Challenges, Uncommon Solutions
Moderator & Speaker: Nancy Kline Leidy PhD, President and CEO, MEDTAP International, Bethesda, MD, USA
The need to communicate value through rigorous scientific evidence common challenge to all areas of health care, including pharma & device, will be discussed.

Overview of PRO Challenges – The Device Industry Perspective
Speaker: Randel Richner MPH, BSN, Vice President, Federal Affairs, Reimbursement and Outcomes Planning, Boston Scientific, Natick, MA, USA
Unique challenges of the medical device industry will be presented.

Accumulation & Presentation Of Scientific Evidence – Regulatory Perspective
Speaker: Neal I. Muni, MD, MSPH, Medical Officer, FDA, Rockville, MD, USA
Making QOL claims for cardiovascular technologies - collaborative efforts between academia, industry, and the FDA…and more.

Panel Discussion


Medical Device & Diagnostics Forum

May 20, 2002
Crystal Gateway Marriot, Arlington, VA, USA


Using Outcomes Research Studies to Support Improved Productivity
Moderator: Pamela Koo, Director, Global Reimbursement Policy Welch Allyn, Inc
Speaker: Sean Sullivan, President & CEO, Institute for Health and Productivity Management, Scottsdale, AZ, USA
Private payers are using HEDIS measurements to imply greater productivity to employers. This presentation will focus on how outcomes research studies can be used to support improved workplace productivity. 

How to Support Reimbursement Of Off-Label Use Of Medical Devices And Diagnostics: Will Outcomes Research Help?
Moderators: Randel Richner RN, MPH, Vice President, Federal Affairs, Reimbursement and Outcomes Planning, Boston Scientific Corporation, Natick, MA, USA and Sarah Wells, Boston Scientific Corporation, Boston, Natick MA, USA
Speaker: Stuart Langbein Esq., Partner, Hogan & Hartson L.L.P. Washington, DC, USA
During the diffusion of innovation process, new medical technologies are used to treat or reduce symptoms in ways other than described on the labeling. This presentation will focus on off-label use of medical and diagnostic technologies, associated reimbursement issues, as well as research opportunities to support reimbursement decisions.

Questions and Answers


Medical Device & Diagnostics Forum

May 20, 2001
Hyatt Regency Crystal City, Arlington


Medical Technology Assessment by Health Plans
Speaker: Jonathan Freudman MD, Medical Advisor, Blue Shield of California, San Francisco, CA, USA

Health Plans do technology assessment because of their desire to see our members receive safe and effective treatments.  Not all treatment modalities fall under the scrutiny of the FDA (off label etc).  FDA clearance of devices does not necessarily assure efficacy.  While some technologies are well studied and have been proven to be effective,  others have received clearance based on limited clinical data.  Insurance coverage is viewed as an endorsement of a treatment modality.  When a treatment is eligible for coverage, further research on the treatment slows or stops.

During the year 2000 the FDA approved several new devices used in the treatment of gastroesophageal reflux (GERD)  based on very limited human clinical data, as well as brachytherapy to treat in-stent  restenosis of coronary artery disease based on significant controlled clinical trials.

We are more likely to look at a new technology if there is a new way to perform a procedure, if there is doubt about the efficacy, or if the current procedure is invasive or costly.

New technologies come to our attention via information from the medical device manufacturing industry, requests for coverage, inquiries from network physicians and health plan members, and the news media including the internet.

A technology will be judged by its safety and efficacy based on the results of clinical trials.  Clinical trials must be appropriately designed and have an adequate control group.

The Blue Cross Blue Shield Association (BCBSA) criteria are the following:

  • Final approval from regulatory body
  • Scientific evidence that permits conclusions on effectiveness regarding health outcomes
  • Must improve net health outcomes
  • Must be as beneficial as any established alternatives
  • Improvement must be attainable outside the investigational setting

The evidence is received through Medline searches, monitoring of the clinical literature, the press and the Internet, and communication with the manufacturers and physicians. Common problems with Clinical trials are lack of control groups, small studies with too few patients to reach a scientifically valid conclusion, insufficient use of randomized control groups and blinded evaluation of results, and lack of clearly defined objective measures.

The following are examples of clinical trials with positive influence on coverage:

**Photodynamic therapy of subfoveal choroidal neovascularization [macular degeneration] (TAP Study Group; Arch Ophthamology Vol 117 October 1999)

  • Double masked, placebo controlled, and randomized
  • The Gold Standard
  • Not possible with all technologies

**Sacral nerve stimulation for the treatment of refractory urinary urge incontinence (Schmidt et al Journal of Urology August 1999)

  • Cross-over design of this clinical trial
  • Other medical devices can be studied in trials with similar design

**Endovascular repair of abdominal aortic aneurysms (Annals of Surgery , 1999 Vol  320, 20)

Without technology assessment there would be less outcome data on which to base clinical decisions, marketing would play an even greater role in the dissemination of new technologies, the cost of health insurance would rise even faster, and the rising cost of health insurance is a threat to access new technologies. In Summation, given our current health care system, technology assessment by health plans is playing an important role.

Effect of Health Technology Assessment on Patient Access
Speaker: Clifford Goodman PhD, Senior Scientist, Medical Technology, The Lewin Group, Falls Church, VA, USA
Health care technology assessment (HTA) involves the systematic evaluation of properties, effects, or other impacts of health care technology, including safety, efficacy/effectiveness, and other aspects.  The main purpose of HTA is to inform policy-making for technology in health care.  Among these types of policy-making are market approval/clearance, third-party payment, clinical practice guidelines, procurement/acquisition, investment, and others.  The increased emphasis on evidence-based health care has enhanced the role of HTA.  Further, the number of HTA agencies and related functions, such as technology “horizon scanning” and “early warning systems”, is increasing worldwide, in particular to support payment decisions by government and private  sector third-party payers.  While evidence requirements and methods for assessment of pharmaceuticals are generally well-developed and accepted, there is less understanding and greater variation in implementing these for assessment of medical devices and diagnostics on the part of HTA organizations as well as technology companies.  This can lengthen the time to market access for these technologies, particularly the time between market clearance and gaining adequate payment.  Of particular importance are differences between evidence for satisfying regulatory requirements for market approval and for satisfying third-party payment requirements.  While market clearance generally applies widely in large countries or regions (e.g., FDA approval in the US and CE marking the Europe), the number of payers and their respective requirements for coverage, coding, and reimbursement can pose a far more complicated set of challenges in the same areas.  These factors increase uncertainty and financial risk for technology companies and can delay access to patients.

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