Journal of the American College of Radiology
Volume 5, Issue 11 , Pages 1125-1129 , November 2008

A Changing Paradigm in the Study and Adoption of Emerging Health Care Technologies: Coverage With Evidence Development

  • Paul E. Wallner, DO

      Affiliations

    • 21st Century Oncology, Inc., Fort Myers, Florida
    • Corresponding Author InformationCorresponding author and reprints: Paul E. Wallner, DO, 140 Fellswood Drive, Moorestown, NJ 08057
  • ,
  • Andre Konski, MD, MBA

      Affiliations

    • Fox Chase Cancer Center, Philadelphia, Pennsylvania

References 

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  2. Franklin GM, Wickizer TM, Fulton-Kehoe D, et al. Policy-relevant research: when does it matter?. NeuroRx. 2004;1:356–362
  3. Hutton J, Trueman P, Henshall C. Coverage with evidence development: an examination of conceptual and policy issues. Int J Technol Assess Health Care. 2007;23:425–432
  4. Tunis SR, Chalkidou K. Coverage with evidence development: a very good beginning, but much to be done. Int J Technol Assess Health Care. 2007;23:432–435
  5. Tunis SR, Pearson SD. Coverage options for promising technologies: Medicare's “coverage with evidence development.”. Health Aff. 2006;25:1218–1230
  6. Pearson SD, Sabin JE, Emmanuel EJ. Medical necessity, coverage decisions, and medical policy. In: No margin, no mission: health care organizations and the quest for ethical excellence. New York: Oxford University Press; 2003;p. 69–71
  7. Daniels N, Sabin JE. Last chance therapies and managed care: pluralism, fair procedures, and legitimacy. Hastings Ctr Rep. 1998;28:27–41
  8. Garber AM. Evidence-based coverage policy. Health Aff. 2001;20:62–82
  9. Centers for Medicare and Medicaid Services. National coverage determinations with data collection as a condition of coverage: coverage with evidence development. https://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8Accessed March 3, 2008
  10. Cooksey D. A review of UK health research funding. http://www.hm-treasury.gov.uk/media/4/A/pbr06_cooksey_final_report_636.pdf
  11. Carino T, Sheingold S, Tunis S. Using clinical trials as a condition of coverage: lessons from the national emphysema treatment trial. Clinical Trials. 2004;1:108–114
  12. National Emphysema Treatment Trial Research Group. A randomized trial comparing lung-volume-reduction surgery with medical therapy for severe emphysema. N Engl J Med. 2003;348:2059–2073
  13. Kolata G. Medicare says it will pay, but patients say “no thanks” (The New York Times). March 3 2006;
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  15. Centers for Medicare and Medicaid Services. Decision memo for pelvic floor electrical stimulation for urinary incontinence (CAG-00021N). http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=61Accessed March 3, 2008
  16. US Food and Drug Administration. Implementation of the FDA/HCFA interagency agreement regarding reimbursement categorization of investigational devices (D95-2). http://www.fda.gov/cdrh/d952.htmlAccessed March 3, 2008
  17. Centers for Medicare and Medicaid Services. Decision memo for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAG-00085N). http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=62Accessed March 3, 2008
  18. Centers for Medicare and Medicaid Services. Decision memo for positron emission tomography (FDG) for Alzheimer's disease/dementia. http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=64Accessed March 3, 2008
  19. Matchar DM. Use of positron emission tomography and other neuroimaging techniques in the diagnosis and management of Alzheimer's disease and dementia (Task Order 7). http://www.cms.gov/coverage/download/id64.pdfAccessed March 3, 2008
  20. Weiss R. Medicare to cover cardiac device (The Washington Post). 2005;January 20
  21. Kadish A. Prophylactic defibrillator implantation—toward an evidence-based approach. N Engl J Med. 2005;352:285–287
  22. McClellan MB, Tunis SR. Medicare coverage of ICDs. N Engl J Med. 2005;352:222–224
  23. Gray BH, Gusmano MK, Collins SR. AHCPR and the changing politics of health services research. Health Aff (Millwood). 2003;3(suppl):283–307
  24. Pearson SD, Miller FG, Emanuel EJ. Medicare's requirement for research participation as a condition of coverage: is it ethical?. JAMA. 2006;296:988–991
  25. Bagley GP, Maxwell R. Linking Medicare coverage to research participation: reasonable and necessary?. http://wvifw.medicarerxguide.com/MDRG/2005/200306_BagleyWLPwhitepaper.pdfAccessed March 3, 2008

PII: S1546-1440(08)00323-2

doi: 10.1016/j.jacr.2008.06.008

Journal of the American College of Radiology
Volume 5, Issue 11 , Pages 1125-1129 , November 2008