Our committee was asked to analyze the possible extension of Medicare coverage for three very different conditions: skin cancer screening, medically necessary dental services, and elimination of time limits on coverage of immunosuppressive drugs for certain transplant recipients. The committee commissioned background papers for review of the evidence published in peer-reviewed scientific papers, heard from interested specialty organizations and patient advocacy groups, and contracted with consultants for estimates of the cost to Medicare of various coverage scenarios. In the course of our work we were struck by the advances in the methods for reporting clinical research, reviewing scientific evidence, and assessing the effectiveness of health care services. At the same time, we saw that continued work was needed to improve these methods and to employ them consistently to guide decisions and recommendations about clinical care and coverage policy. We include in this report our observations of these systemic problems with coverage decision making and offer some examples of different approaches for the Congress to consider.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON MEDICARE COVERAGE EXTENSIONS
• Acknowledgments
• Preface
• Summary
• 1. Introduction
  • THE MEDICARE PROGRAM
  • MEDICARE COVERAGE DECISIONS
  • COVERAGE, ACCESS TO CARE, AND OUTCOMES
  • OVERVIEW OF THE REPORT
• 2. Objectives, Principles, and Methods
  • OBJECTIVES AND PRINCIPLES
  • ANALYTIC STRATEGY
  • ESTIMATING COSTS TO MEDICARE OF EXTENDING COVERAGE
• 3. Screening for Skin Cancer
  • ASSESSMENT APPROACH: INTERVENTION, POPULATION, AND OUTCOMES
  • POPULATION BURDEN OF DISEASE
  • AVAILABILITY OF EFFECTIVE TREATMENT
  • SCREENING AND DIAGNOSTIC PROCEDURES
  • BENEFITS AND HARMS OF SKIN CANCER SCREENING
  • EVIDENCE OF BENEFITS FROM EARLY DETECTION OF SKIN CANCER THROUGH SCREENING
  • ESTIMATED COSTS TO MEDICARE OF EXTENDING COVERAGE
  • STATEMENTS OF OTHERS ABOUT SKIN CANCER SCREENING
  • COMMITTEE FINDINGS AND CONCLUSIONS
• 4. Medically Necessary Dental Services
  • DEFINING MEDICALLY NECESSARY DENTAL SERVICES
  • ASSESSMENT APPROACH: INTERVENTION, POPULATION, AND OUTCOMES
  • HEAD AND NECK CANCER
  • LEUKEMIA AND LYMPHOMA
  • SOLID ORGAN TRANSPLANTS
  • HEART VALVE REPAIR OR REPLACEMENT
  • ESTIMATED COSTS TO MEDICARE OF EXTENDING COVERAGE
  • STATEMENTS OF OTHERS ON “MEDICALLY NECESSARY DENTAL SERVICES”
  • COMMITTEE FINDINGS AND CONCLUSIONS
• 5. Immunosuppressive Drugs for Transplant Patients
  • EVOLUTION OF IMMUNOSUPPRESSIVE DRUG COVERAGE BY MEDICARE
  • ASSESSMENT APPROACH
  • BURDEN OF DISEASE
  • AVAILABILITY OF EFFECTIVE TREATMENT
  • BARRIERS TO ADEQUATE THERAPY
  • ESTIMATED COSTS TO MEDICARE OF EXTENDING COVERAGE
  • STATEMENTS OF OTHERS ON COVERAGE FOR IMMUNOSUPPRESSANTS
  • COMMITTEE FINDINGS AND CONCLUSIONS
• 6. Future Directions
  • LINKING EVIDENCE TO MEDICARE COVERAGE: THE CASE OF PREVENTIVE SERVICES
  • STRENGTHENING THE INFRASTRUCTURE FOR COVERAGE DECISIONS
  • THE LIMITS OF COVERAGE
  • THE LIMITS OF EVIDENCE
• References
• APPENDIX A Study Activities
• APPENDIX B Screening for Skin Cancer
• APPENDIX C Medically Necessary Dental Services
• APPENDIX D, PART 1 Immunosuppressive Therapy: The Scientific Basis and Clinical Practice of Immunosuppressive Therapy in the Management of Transplant Recipients
• APPENDIX D, PART 2 Transplantation and Immunosuppressive Medications: Evolution of Medicare Policy Involving Transplantation and Immunosuppressive Medications—Past Developments and Future Directions
• APPENDIX E Cost Estimates for Expanded Medicare Benefits: Skin Cancer Screening, Medically Necessary Dental Services, and Immunosuppressive Therapy for Transplant Recipients
• APPENDIX F Committee Biographies

Support for this project was provided by the Department of Health and Human Services (Contract Number 500–98–0275). The views presented are those of the Institute of Medicine Committee and are not necessarily those of the funding organization.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.