Toward evidence-based assessment for coverage and reimbursement of laboratory-based diagnostic and genetic tests

American Journal of Managed Care

Volumn 12, Issue 4, 2006, Pages 197-202

  Ramsey, Scott D ^a,b   Veenstra, David L ^b   Garrison Jr , Louis P ^b   Carlson, Rick ^b   Billings, Paul ^c   Carlson, Josh ^b   Sullivan, Sean D ^b  

^a Fred Hutchinson Cancer Research Center   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c LABORATORY CORPORATION OF AMERICA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIAGNOSTIC TEST; EVIDENCE BASED MEDICINE; GENETIC SERVICE; HEALTH CARE COST; HEALTH CARE DELIVERY; HEALTH INSURANCE; PRIORITY JOURNAL; REIMBURSEMENT; REVIEW; STANDARDIZATION; UNITED STATES;

EVIDENCE-BASED MEDICINE; GENETIC SCREENING; HUMANS; INSURANCE COVERAGE; LABORATORY TECHNIQUES AND PROCEDURES; REIMBURSEMENT MECHANISMS; UNITED STATES;

EID: 33645925323     PISSN: 10880224     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (34)

1. Food and Drug Administration, Department of Health and Human Services. CFR Title 21 809.3. Title 21: Food and Drugs. Subchapter H: Medical Devices. Part 809: In vitro diagnostic products for human use. Subpart A: General provisions. Section 809.3 definitions. Available at: http://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm. Accessed August 2005.
2. BlueCross BlueShield Association. Medical Technology as a Driver of Healthcare Costs: Diagnostic Imaging. Available at: http://www.bcbs.com/ coststudies/reports/Medical_Tech_Drivr_Rept_10.pdf. Accessed August 2005.
3. The Lewin Group. The Value of Diagnostics Innovation, Adoption and Diffusion into Health Care. Report prepared for The Advanced Medical Technology Association (AdvaMed). July 2005. Available at: http://www.advamed.org/ publicdocs/thevalueofdiagnostics.pdf. Accessed August 2005.
4. Feinstein AR. Misguided efforts and future challenges for research on "diagnostic tests." J Epidemiol Community Health. 2002;56:330-332.
5. Reid MC, Lachs MS, Feinstein AR. Use of methodological standards in diagnostic test research. Getting better but still not good. JAMA. 1995;274:645-651.
6. Weinstein S, Obuchowski NA, Lieber ML. Clinical evaluation of diagnostic tests. Am J Roentgenol. 2005;184:14-19.
7. Neumann PJ. Evidence-based and value-based formulary guidelines. Health Aff (Millwood). 2004;23:124-134.
8. Raab GG, Logue LJ. Medicare coverage of new clinical diagnostic laboratory tests: the need for coding and payment reforms. Clin Leadersh Manag Rev. 2001;15:376-387.
9. Fendrick AM, Smith DG, Chernew ME, Shah SN. A benefit-based copay for prescription drugs: patient contribution based on total benefits, not drug acquisition cost. Am J Manag Care. 2001;7:861-867.
10. Collins FS. Shattuck lecture-medical and societal consequences of the Human Genome Project. N Engl J Med. 1999;341:28-37.
11. Langheier JM, Snyderman R. Prospective medicine: the role for genomics in personalized health planning. Pharmacogenomics. 2004;5:1-8.
12. Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA). Available at: http://www.cms.hhs.gov/clia/. Accessed November 2005.
13. Young DS. Earning your keep: succeeding in laboratory reimbursement. Clin Chem. 1998;44:1701-1712.
14. Young DS. Reforming laboratory reimbursement, issues, impact and innovations. A summary of the clinical chemistry forum held on November 15, 2001. Clin Chem. 2002;48:792-795.
15. Centers for Medicare & Medicaid Services. Glossary. Available at http://www.cms.hhs.gov/glossary/. Accessed August 2005.
16. Wolman DM, Kalfoglou AL, LeRoy L, eds. Medicare Laboratory Payment Policy: Now and in the Future. Washington, DC: The National Academies Press; 2000:17.
17. Rappaport KM, Forrest CB, Holtzman NA. Adoption of liquid-based cervical cancer screening tests by family physicians and gynecologists. Health Serv Res. 2004;39(4 pt 1):927-947.
18. Tatsioni A, Zarin DA, Aronson N, et al. Challenges in systematic reviews of diagnostic technologies. Ann Intern Med. 2005;142:1048-1055.
19. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991;11:88-94.
20. Buxton MJ, Drummond MF, Van Hout BA, et al. Modelling in economic evaluation: an unavoidable fact of life. Health Econ. 1997;6:217-227.
21. Weinstein MC, O'Brien B, Hornberger J, et al. Principles of good practice for decision analytic modeling in health-care evaluation: report of the ISPOR Task Force on Good Research Practices-Modeling Studies. Value Health. 2003;6:9-17.
22. Petitti DB. Meia-Analysis, Decision Analysis, and Cost-Effectiveness Analysis: Methods for Quantitative Synthesis in Medicine. New York, NY: Oxford University Press; 2000.
23. Fry R, Avey S, Sullivan S. The Academy of Managed Care Pharmacy Format for Formulary Submissions: an evolving standard. A Foundation for Managed Care Pharmacy Task Force report. Value Health. 2003;6:505-521.
24. Nierenberg AA, Feinstein AR. How to evaluate a diagnostic marker test. Lessons from the rise and fall of dexamethasone suppression test. JAMA. 1988;259:1699-1702.
25. Banta HD, Thacker SB. Electronic fetal monitoring. Lessons from a formative case of health technology assessment. Int J Technol Assess Health Care. 2002;18:762-770.
26. Blackmore CC, Black WC, Jarvik JG, Langlob CP. A critical synopsis of the diagnostic and screening radiology outcomes literature. Acad Radiol. 1999;6(suppl 1):S8-S18.
27. Wainberg S, Husted J. Utilization of screening and preventive surgery among unaffected carriers of a BRCA1 or BRCA2 gene mutation. Cancer Epidemiol Biomarkers Prev. 2004;13:1989-1995.
28. Food and Drug Administration, Department of Health and Human Services. Notice. Agency information collection activities; submission for OMB review; comment request; medical devices; classification/reclassification; restricted devices: analyte specific reagents. Fed Regist. January 5, 2001;66:1140-1141. Available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/010501c.htm. Accessed August 2005.
29. Goldman DP, Schoenbaum ML, Potosky AL, et al. Measuring the incremental cost of clinical cancer research. J Clin Oncol. 2001;19:105-110.
30. Rockey D. The crisis in clinical research [letter]. JAMA. 1999;282:1914; author reply 1915-1916.
31. Nathan DG. Clinical research: perceptions, reality, and proposed solutions. National Institutes of Health Director's Panel on Clinical Research. JAMA. 1998;280:1427-1431.
32. Antman K, Schnipper LE, Frei E 3rd. The crisis in clinical cancer research. Third-party insurance and investigational therapy. N Engl J Med. 1988;319:46-48.
33. Reinhardt UE. An information infrastructure for the pharmaceutical market. Health Aff (Millwood). 2004;23:107-112.
34. Chapman S, Reeve E, Rajaratnam G, Neary R. Setting up an outcomes guarantee for pharmaceutical: new approach to risk sharing in primary care. Biol. 2003;326:707-709.