VOLUME 35 NUMBER 7 JULY 2017 NATURE BIOTECHNOLOGY conditions; other analyses have examined coverage for panels including BRCA1/2 (ref. 5), coverage of non-invasive prenatal screening tests6, and the evidence cited… Click to show full abstract
VOLUME 35 NUMBER 7 JULY 2017 NATURE BIOTECHNOLOGY conditions; other analyses have examined coverage for panels including BRCA1/2 (ref. 5), coverage of non-invasive prenatal screening tests6, and the evidence cited in coverage decisions7. Our initial version (Version 1.0) of the registry includes publicly available national policies from the five largest US private (commercial) payers, representing 112 million enrollees8, though these policies do not necessarily reflect regional polices pertaining to particular benefit designs of states, unions, or individual private companies. (To our knowledge, it would be unlikely that such policies would single out multigene tests for separate coverage.) Policies current as of June 2015 were systematically coded by two authors (M.P.D. and P.A.D., with review by a third author K.A.P.) (Supplementary Methods). As noted previously9, policies are contextspecific and thus we classified tests into the following categories: tumor profiling; inherited disease testing for neurologic, cancer, cardiovascular, or biochemical disorders; drug metabolism testing; whole exome or whole genome sequencing; and prenatal testing or carrier testing (Table 2). Policies discuss multigene tests using either a general description for the type of panel (e.g., “cancer susceptibility testing”) or a specific brand name (e.g., “BreastNext”). Tests may be included (‘mentioned’) or not included in a policy. When included, tests can be determined to be covered or not covered. Thus, some tests may have unknown coverage because they are not included or mentioned in a policy. Tests were placed into one of three mutually exclusive categories. 1. Covered when mentioned. Test is covered for at least one indication in that policy and not specifically excluded in any other policy. Multigene tests within the same policy that were covered for some clinical indications but not others were coded as “covered.” 2. Not covered when mentioned. Not covered in any policies that specifically mention the test. Payer coverage policies for multigene tests
               
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