Excerpt

Point of care laboratory testing is the most rapidly growing segment of the clinical laboratory market, with a projected increase in sales from $4.2 billion to $6.2 billion between 2002 and 2007, representing an 8.1% increase.¹ The rising prevalence of this technology will present the Centers for Medicare and Medicaid Services (CMS) with a variety of issues surrounding the quality of care and cost effectiveness for Medicare beneficiaries. CMS has requested objective data in the form of technology assessments to better inform coverage and payment decisions that CMS will need to make in the future.

Contents

• 1.0. Overview
  • 1.1 Salience of a Technology Assessment of Point of Care Hemoglobin A1c Testing Devices
  • 1.2 Questions Posed by CMS Regarding Point of Care HbA1c Testing Devices
• 2.0. Methods
  • 2.1 Search Strategy
• 3.0. Results
  • 3.1 Question 1: What is the evidence on the performance of the tests measuring hemoglobin A1c in the point of care setting and the laboratory setting?
  • 3.2 Question 2. Is there evidence that performing hemoglobin A1c at the point of care influences patient management decisions compared to performing the test in the laboratory setting?
  • 3.3 Question 3: Is there direct evidence (from clinical studies) or indirect evidence (e.g., from clinical studies integrated using a model) that performing hemoglobin A1c at the point of care results in better clinical outcomes for Medicare beneficiaries, such as reduced length of stay, decreased morbidity and mortality, and improved quality of life, compared to performing the test in a laboratory setting?
  • Question 4: Is there evidence quantifying the impact of point of care testing for HbA1c on health care expenditures?
• 4.0. Summary
• Appendix A Criteria for accuracy and precision disseminated by the National Glycohemoglobin Standardization Program (NGSP) Certification Protocol
• Appendix B Factors that interfere with GHB (HbA1c) Test Results
• Appendix C Effects of frequently encountered Hb variants and derivatives on GHB measurement
• References
• List of Acronyms/Abbreviations

This report is based on research conducted by the Duke Evidence-based Practice Center (EPC), under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0025). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers, patients and clinicians, health system leaders, and policymakers make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report as they would any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. Neither AHRQ’s nor the U.S. Department of Health and Human Services’ endorsement of such derivative products may be stated or implied.