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Health insurers play a critical role in determining patient access to new medical technology. If insurers won't cover them, new tests and therapies are less likely to be introduced and used. A recent national survey of people who make the coverage decisions for health insurers about genetic testing and gene therapies revealed that insurers base their decisions on the validity of tests and the safety and effectiveness of gene therapies.
Coverage decisionmakers surveyed represented health maintenance organizations, preferred provider organizations, indemnity plans, and self-insured employer health plans that were identified from insurance membership directories. They were asked whether they would cover cystic fibrosis (CF) carrier screening, testing for genetic susceptibility to breast cancer (test for the BRCA gene), and medical costs of a clinical trial of gene therapy for CF under certain conditions.
Only 4 to 15.5 percent of all insurers covered these services at the time of the study. Coverage decisions did not differ by type of insurance organization. Insurers said they would significantly increase coverage of CF carrier screening and BRCA testing if the group tested was restricted to those at high risk for developing the diseases, if disease detection rates were higher and costs lower, and if testing was endorsed by a national professional group or consensus conference. Insurers said they would also be more likely to cover the medical costs of a trial of CF gene therapy if the trial was restricted to children or adults with severe CF, safety and effectiveness were proven, and therapy could be administered in a regional hospital or an outpatient setting rather than in a research hospital.
Only half of respondents considered CF carrier screening of all pregnant women to be medically appropriate, and fewer considered the BRCA test or the CF gene therapy trial to be medically appropriate. The majority agreed that the detection rate of the two tests was adequate, but over three-fourths agreed on the potential for psychological harm from the BRCA test. Few respondents thought there was great potential for future cost savings by offering the tests. The study was supported in part by the Agency for Healthcare Research and Quality (doctoral dissertation grant HS08461) and led by Michele M. Schoonmaker, of Vysis, Inc.
See "Factors influencing health insurers' decisions to cover new genetic technologies," by Ms. Schoonmaker, Barbara A. Bernhardt, and Neil A. Holtzman, in the International Journal of Technology Assessment in Health Care 16(1), pp. 178-189, 2000.
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