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

Sean R. Tunis, Steven D. Pearson

Research output: Contribution to journalArticle

Abstract

In April 2005 the Centers for Medicare and Medicaid Services (CMS) posted on its Web site a draft guidance document describing a new approach to coverage policy called "coverage with evidence development" (CED). CED offered an option for coverage of promising drugs, biologics, devices, diagnostics, and procedures that would not otherwise meet Medicare's evidentiary standards for being "reasonable and necessary." An updated guidance was posted 12 July 2006, clarifying several key statutory, regulatory, and operational issues. This paper traces the history of this policy approach, explains the rationale behind the policy, and describes the major challenges that will need to be addressed for CED to become an important advance in evidence-based coverage decision making.

Original languageEnglish (US)
Pages (from-to)1218-1230
Number of pages13
JournalHealth Affairs
Volume25
Issue number5
DOIs
StatePublished - 2006
Externally publishedYes

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Medicare
coverage
Technology
evidence
Centers for Medicare and Medicaid Services (U.S.)
Biological Products
Decision Making
History
Equipment and Supplies
policy approach
Pharmaceutical Preparations
diagnostic
drug
decision making
history

ASJC Scopus subject areas

  • Nursing(all)
  • Health(social science)
  • Health Professions(all)
  • Health Policy

Cite this

Coverage options for promising technologies : Medicare's 'Coverage with evidence development'. / Tunis, Sean R.; Pearson, Steven D.

In: Health Affairs, Vol. 25, No. 5, 2006, p. 1218-1230.

Research output: Contribution to journalArticle

Tunis, Sean R. ; Pearson, Steven D. / Coverage options for promising technologies : Medicare's 'Coverage with evidence development'. In: Health Affairs. 2006 ; Vol. 25, No. 5. pp. 1218-1230.
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