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Related Experiment Videos

Coverage options for promising technologies: Medicare's 'coverage with evidence development'.

Sean R Tunis1, Steven D Pearson

  • 1Center for Medical Technology Policy. sean.tunis@netzero.net

Health Affairs (Project Hope)
|September 13, 2006
PubMed
Summary

The Centers for Medicare and Medicaid Services introduced Coverage with Evidence Development (CED) for promising medical technologies. This policy aims to improve evidence-based coverage decisions by addressing key challenges.

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Area of Science:

  • Health Policy
  • Medical Technology Assessment
  • Evidence-Based Medicine

Background:

  • The Centers for Medicare and Medicaid Services (CMS) introduced Coverage with Evidence Development (CED) in April 2005.
  • CED provides an option for Medicare coverage of novel drugs, biologics, devices, diagnostics, and procedures lacking sufficient evidence.
  • An updated guidance in July 2006 clarified statutory, regulatory, and operational aspects of the CED policy.

Purpose of the Study:

  • To trace the historical development of the Coverage with Evidence Development (CED) policy.
  • To elucidate the underlying rationale and justification for the CED policy approach.
  • To identify and describe significant challenges hindering the effective implementation of CED.

Main Methods:

  • Historical policy analysis of CMS documents and guidance.

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  • Review of statutory and regulatory frameworks governing Medicare coverage.
  • Examination of operational considerations for implementing evidence development.

    • Main Results:

    • CED was established as a policy to bridge the evidence gap for innovative medical items and services.
    • The policy aims to ensure Medicare coverage aligns with 'reasonable and necessary' standards through evidence generation.
    • Several statutory, regulatory, and operational issues required clarification and refinement since the policy's inception.

    Conclusions:

    • Coverage with Evidence Development (CED) represents a significant policy innovation for Medicare coverage decision-making.
    • Addressing identified challenges is crucial for CED to realize its potential in advancing evidence-based coverage.
    • Successful implementation of CED can enhance the integration of new medical technologies into patient care.