Medicare's national coverage decisions for technologies, 1999-2007

Health Affairs

Volumn 27, Issue 6, 2008, Pages 1620-1631

  Neumann, Peter J ^a   Kamae, Maki S ^a   Palmer, Jennifer A ^a  

^a TUFTS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; CANCER CHEMOTHERAPY; CARDIOVASCULAR DISEASE; COCHLEA PROSTHESIS; COLORECTAL CANCER; DECISION MAKING; DEFIBRILLATOR; DEMENTIA; DEVICE; DIAGNOSTIC IMAGING; DIAGNOSTIC PROCEDURE; DIAGNOSTIC TEST; EVIDENCE BASED MEDICINE; HEALTH CARE POLICY; HEALTH CARE UTILIZATION; HEALTH EDUCATION; HEALTH INSURANCE; HEARING LOSS; HOME OXYGEN THERAPY; HUMAN; LABORATORY TEST; LUNG RESECTION; MEDICAID; MEDICAL TECHNOLOGY; MEDICARE; NEOPLASM; POSITRON EMISSION TOMOGRAPHY; REVIEW; RISK BENEFIT ANALYSIS;

DECISION MAKING; INSURANCE CLAIM REVIEW; INSURANCE COVERAGE; MEDICARE; ORGANIZATIONAL POLICY; TECHNOLOGY, MEDICAL; UNITED STATES;

EID: 56649086565     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.27.6.1620     Document Type: Review

References (50)

1. P.J. Neumann et al., "Medicare's National Coverage Decisions, 1999-2003: Quality of Evidence and Review Times," Health Affairs 24, no. 1 (2005): 243-254;
2. "Medicare Program: Procedures for Making National Coverage Decisions," Federal Register 64, no. 80 (27 April 1999): 22619-22625;
3. and Centers for Medicare and Medicaid Services, "Notice: Medicare Program; Revised Process for Making Medicare National Coverage Determinations," Federal Register 68, no. 187 (26 September 2003): 55634-55641.
4. Social Security Amendments, Sec. 1862 [a][1], 1965.
5. S.B. Foote, "Why Medicare Cannot Promulgate a National Coverage Rule: A Case of Regula Mortis," Journal of Health Politics, Policy and Law 27, no. 5 (2002): 707-730;
6. and "Notice: Medicare Program; Revised Process."
7. "Medicare Program: Establishment of the Medicare Coverage Advisory Committee and Request for Nominations for Members," Federal Register 63, no. 239 (14 December 1998): 68780;
8. and "Medicare Program; Renewal and Renaming of the Medicare Coverage Advisory Committee (MCAC) to Medicare Evidence Development Coverage Advisory Committee (MEDCAC) and a Request for Nominations for Members for the Medicare Evidence Development and Coverage Advisory Committee," Federal Register 72, no. 17 (26 January 2007): 3853-3854.
9. CMS, "National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development," 12 July 2006, http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=8 (accessed 12 August 2008).
10. CMS, "Factors CMS Considers in Opening a National Coverage Determination," 11 April 2006, http://www.cms.hhs.gov/mcd/ ncpc_view_document.asp?id=6 (accessed 12 August 2008).
11. CMS, "Factors CMS Considers in Referring Topics to the Medicare Evidence Development and Coverage Advisory Committee," 12 December 2006, http://www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=10 (accessed 12 August 2008);
12. and CMS, "Factors CMS Considers in Commissioning External Technology Assessments," 11 April 2006, http://www.cms.hhs.gov/mcd/ ncpc_view_document.asp?id=7 (accessed 12 August 2008).
13. "Medicare Program: Establishment";
14. "Medicare Program: Procedures";
15. and Neumann et al., "Medicare's National Coverage Decisions."
16. CMS, "Factors CMS Considers in Making a Determination of Coverage with Evidence Development" (Baltimore: CMS, April 2005).
17. CMS, "National Coverage Determinations";
18. and S.R. Tunis and S.D. Pearson, "Coverage Options for Promising Technologies: Medicare's 'Coverage with Evidence Development'," Health Affairs 25, no. 5 (2006): 1218-1230. This guidance introduced subcategories of CED: "coverage with appropriateness determination," in which a coverage decision is made with additional data collection to assure that an item or service is only being provided appropriately according to clinical criteria specified in the decision; and "coverage with study participation," in which evidence is not adequate for a "reasonable and necessary" determination but would be adequate if a patient were enrolled in a trial that would ultimately provide reliable evidence.
19. CMS, "Factors CMS Considers in Opening";
20. CMS, "Factors CMS Considers in Referring Topics";
21. and CMS, "Factors CMS Considers in Commissioning."
22. Neumann et al., "Medicare's National Coverage Decisions."
23. In our analysis, we reviewed all Medicare national coverage decisions posted on the CMS Web site for which there was an accompanying decision memorandum. We use the general term "NCD," as is commonly done, to refer to each of these as national coverage decisions. As of implementation of MMA1 January 2004, Medicare has distinguished National Coverage Analyses (NCAs) from National Coverage Determinations (NCDs). An NCA refers to the decision memorandum presenting the analysis underlying decisions. An NCD in this sense follows as the regulatory or legal document executing the coverage decision. All NCAs should have an NCD, but there are many more NCDs than NCAs, because NCDs also include decisions such as Coverage Analyses of Laboratories (CALs),which alter the covered diagnosis codes and coding guidance in laboratory decisions. Before MMA's passage, the CMS did not use the NCA/NCD distinction. The CMS's documentation of NCDs on its Web site has changed over time and continues to evolve. CMS, "Medicare Coverage Database: Overview," http://www.cms.hhs.gov/mcd/overview.asp (accessed 9 April 2008).
24. We recorded all technology-specific MEDCAC meetings and HTAs. Our numbers differ from those listed on the CMS Web site because we excluded non-technology-specific meetings, technology-specific meetings for interventions that did not have an exact match with an NCD in our database, and technology-specific meetings that occurred after the technology's NCA and NCD closed. Similarly, our HTA numbers differ from those on the CMS Web site because we excluded HTAs that did not have an exact match with an NCD in our database, were produced after the technology' sNCA and NCD closed, or were partially redundant with another HTA.
25. Agency for Healthcare Research and Quality, "U.S. Preventive Services Task Force Ratings: Strength of Recommendations and Quality of Evidence," in Guide to Clinical Preventive Services, Third Edition: Periodic Updates, 2000-2003, http://www.ahrq.gov/clinic/3rduspstf/ratings. htm (accessed 12 August 2008).
26. The full NCD list is available from the authors. Send e-mail to pneumann@tuftsmedicalcenter.org.
27. Neumann et al., "Medicare's National Coverage Decisions."
28. P.S. Keenan, P.J. Neumann, and K.A. Phillips, "Biotechnology and Medicare's New Technology Policy: Lessons from Three Case Studies," Health Affairs 25, no. 5 (2006): 1260-1269.
29. Steve E. Phurrough, director, CMS Coverage and Analysis Group, personal communication, 24 March 2008.
30. Neumann et al., "Medicare's National Coverage Decisions."
31. T. Carino et al., "Medicare's Coverage of Colorectal Cancer Drugs: A Case Study in Evidence Development and Policy," Health Affairs 25, no. 5 (2006): 1231-1239.
32. G. Kolata, "Medicare Says It Will Pay, but Patients Say 'No Thanks'," New York Times, 3 March 2006.
33. Tunis and Pearson, "Coverage Options."
34. Ibid.; S.D. Pearson, F.G. Miller, and E.J. Emanuel, "Medicare's Requirement for Research Participation as a Condition of Coverage: Is It Ethical?" Journal of the American Medical Association 296, no. 8 (2006): 988-991;
35. Carino et al., "Medicare's Coverage";
36. and International Society for Pharmacoeconomics and Outcomes Research, "Re: Draft Guidance for Factors CMS Considers in Making a Determination of Coverage with Evidence Development" (letter), 6 June 2005, http://www.ispor.org/workpaper/Draft_Guidance_for_Factors_CMS.pdf (accessed 12 August 2008).
37. Tunis and Pearson, "Coverage Options."
38. Avalere Health, Evidence-Based Medicine Update (Washington: Avalere Health, 14 January 2008).
39. G.H. Guyatt et al., "GRADE: An Emerging Consensus on Rating Quality of Evidence and Strength of Recommendations," British Medical Journal 336, no. 7650 (2008): 924-926.
40. See, for example, J. Whalen, "Europe's Drug Insurers Try Pay-for-Performance," Wall Street Journal, 12 October 2007;
41. A. Pollack, "Pricing Pills by the Results," New York Times, 14 July 2007;
42. and N. Timmins, "Experts See Health Benefits in Drugs 'Guarantee'," Financial Times, 4 June 2007.
43. Medicare Payment Advisory Commission, Report to the Congress: Promoting Greater Efficiency in Medicare (Washington: MedPAC, June 2007);
44. Congressional Budget Office, Research on the Comparative Effectiveness of Medical Treatments: Issues and Options for an Expanded Federal Role (Washington: CBO, December 2007);
45. and G.R. Wilensky, "Developing a Center for Comparative Effectiveness Information," Health Affairs 25, no. 6 (2006): w572-w585 (published online 7 November 2006; 10.1377/ hlthaff.25.w572).
46. P.J. Neumann, A.B. Rosen, and M.C. Weinstein, "Medicare and Cost-Effectiveness Analysis," New England Journal of Medicine 353, no. 14 (2005): 1516-1522;
47. M.A. Hlatky, G.D. Sanders, and D.K. Owens, "Evidence-Based Medicine and Policy: The Case of the Implantable Cardioverter Defibrillator," Health Affairs 24, no. 1 (2005): 42-51;
48. and Keenan et al., "Biotechnology and Medicare's New Technology Policy."
49. M.F. Drummond et al., "Key Principles for the Improved Conduct of Health Technology Assessments for Resource Allocation Decisions," International Journal of Technology Assessment in Health Care 24, no. 3 (2008): 224-258.
50. S.B. Foote et al., "The Impact of Medicare Coverage Policies on Health Care Utilization," Health Services Research 43, no. 4 (2008): 1285-1301.