OBJECTIVES: The adoption of elective biomarker tests within US health plans has been slow. Without standardized guidelines, payers vary in their coverage policies of elective biomarker diagnostics. The aim of this study was to identify factors, including the positive predictive value (PPV) of a test, that influence current coverage and reimbursement practices of elective biomarker tests amongst US payers. METHODS: Independent assessments were conducted with two groups of US payers comprised of both medical and pharmacy directors from national and regional health plans. In October 2013, a focus group of 44 US payers used 7-point Likert scales to evaluate hypothetical scenarios involving varying PPVs. In December 2013, 60 US payers were surveyed using 7-point Likert scales to categorize factors that influence the coverage of elective biomarker diagnostics within their health plans. Elective biomarkers were defined as diagnostic tests that are not required as part of the FDA-approved labeling, but may be used in conjunction since evidence demonstrates that test results may determine treatment choices and/or outcomes. Chi-squared analyses are in progress to observe differences in responses between the two independent payer groups, medical and pharmacy directors, as well as national and regional health plans. RESULTS: Based on focus group results, 6 (13.6%), 13 (29.5%), 31 (70.5%), and 40 (90.1%) US payers were more likely to cover biomarker tests as PPV increased from 20%, 40%, 60% and 80%, respectively. 52 (86.6%) surveyed payers rated the ability to predict the effectiveness of a particular therapy, and 42 (70.0%) rated the ability to reduce the frequency of other clinical tests as the main factors influencing coverage decisions. CONCLUSIONS: In lieu of standardized guidelines, this research indicates that the more accurate and effective the biomarker test is at determining treatment choices and/or outcomes, the more likely it will be covered by US health plans.