Excerpt

The Centers for Medicare & Medicaid Services (CMS) requested that AHRQ commission an evidence report to assist in updating the CMS policy regarding cardiac catheterization in freestanding clinics. Accordingly, on February 9^th 2005, AHRQ issued a Statement of Work (SOW) contracting ECRI to prepare an evidence report on this topic. In commissioning this report, AHRQ, in consultation with CMS and ECRI, developed five Key Questions to be addressed. These questions are as follows:

1. Do freestanding cardiac catheterization clinics and hospitals have comparable complication rates for diagnostic catheterization procedures?
2. Do freestanding cardiac catheterization clinics and hospitals have comparable complication rates for interventional catheterization procedures?
3. Do hospitals without cardiac surgical support and hospitals with cardiac surgical support have comparable complication rates for diagnostic and interventional catheterization procedures? This question will only be addressed if the literature is insufficient for questions 1 and/or 2 for freestanding clinics.
4. What are the characteristics of patients who have had catheterization procedures in freestanding cardiac catheterization clinics vs. hospitals?
5. What are the current state regulations, Certificate of Need (CON) requirements, and oversight procedures for freestanding cardiac catheterization clinics? Include a table summarizing regulations from all 50 states. Include also a review of international regulations and guidelines; at a minimum include information from the U.K. and Canada.

Contents

• EXECUTIVE SUMMARY
• SCOPE OF REPORT
• BACKGROUND
  • Cardiac Catheterization
  • Freestanding Cardiac Catheterization Clinics
  • Clinical Practice Guidelines
  • Ongoing Trials
• METHODS
  • Key Questions Addressed
  • Literature Searches
  • Inclusion/Exclusion Criteria
  • Data Extraction
  • Evaluation of the Quality of the Evidence Base
• EVIDENCE SYNTHESIS
  • Key Question 1 Do Freestanding Cardiac Catheterization Clinics and Hospitals Have Comparable Complication Rates for Diagnostic Catheterization Procedures?
  • Key Question 2 Do Freestanding Cardiac Catheterization Clinics and Hospitals Have Comparable Complication Rates for Interventional Catheterization Procedures?
  • Key Question 3 Do Hospitals without Cardiac Surgical Support and Hospitals with Cardiac Surgical Support have Comparable Complication Rates for Interventional Catheterization Procedures?
  • Key Question 4 What Are the Characteristics of Patients Who Have Had Catheterization Procedures in Freestanding Cardiac Catheterization Clinics vs. Hospitals?
  • Key Question 5 What Are the Current State Regulations, Certificate of Need (CON) Requirements, and Oversight Procedures for Freestanding Cardiac Catheterization Clinics?
  • Conclusions
• BIBLIOGRAPHY
• APPENDICES: SUPPORTING DOCUMENTATION AND EVIDENCE TABLES
  • Appendix A Literature Searches
  • Appendix B Excluded Studies
  • Appendix C Evidence Tables for Key Question 1
  • Appendix D Evidence Tables for Key Question 3
  • Appendix E Evidence Tables for Key Question 4
  • Appendix F Regulations and Standards (Key Question 5)

This report is based on research conducted by the ECRI Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0019). The findings and conclusions in this document are those of the author(s) 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 the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decision-makers; 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. Decisions concerning the provision of clinical care should consider this report in the same way as 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. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.