Exploring options for improving healthcare.

Journal Article (Journal Article;Review)

New medical technologies generally must receive clearance or approval for marketing by the US Food and Drug Administration and be covered by an insurer, such as the Centers for Medicare and Medicaid Services, before becoming available for widespread clinical use. These 2 approval processes are discrete and usually occur sequentially rather than collaboratively and simultaneously. To explore potential mechanisms for increasing regulatory collaboration between these 2 key health care agencies, the Duke Clinical Research Institute and Health Strategies Consultancy convened an informal meeting of agency, academic, and industry leaders on December 8 and 9, 2002, titled "Registration/Approval and Coverage/Payment: Exploring Options for Improving Healthcare." This article arises from the discussion at this conference; it does not represent the official views of any person or institution involved. Although the group did not attempt to reach a consensus, it examined several important issues surrounding this regulatory debate. Herein are proposed options for enhancing regulatory efficiency through greater coordination between the FDA and CMS, and discussion of these proposals from the perspectives of members of both agencies, members of stakeholder organizations, and academic observers.

Full Text

Duke Authors

Cited Authors

  • Wang, SS; Mendelson, DN; Schulman, KA; Mark, DB

Published Date

  • January 2004

Published In

Volume / Issue

  • 147 / 1

Start / End Page

  • 23 - 30

PubMed ID

  • 14691414

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2003.09.006


  • eng

Conference Location

  • United States