Insurance coverage of germline genetic testing for ovarian, pancreatic, and early-onset colorectal, endometrial, and breast cancers, stratified by self-reported race and ethnicity.

Abstract

11080 Background: Universal germline genetic testing (GGT) for patients with ovarian (OV), pancreatic (PANC), and early-onset colorectal, endometrial cancer, and breast cancer (CRC <50, ENDO <50, and BR ≤50) is the medically necessary standard of care per clinical guidelines and many payer medical policies. Individuals with multiple cancers, diagnosed at any age (MULTI), also commonly meet these guidelines for GGT. We report a single national laboratory experience with GGT coverage for these indications. Methods: Patients with GGT between 6/1-12/31/2023 from a commercial laboratory were stratified by cancer type (using ICD-10s), age at testing, and self-reported race and ethnicity. We assessed differences in coverage rates, frequency and types of denial codes (technical and clinical denials), and appeal success across cancer types. Reported p-values are from G-Tests of independence, only groups containing at least 100 individuals were retained in statistical tests. Results: We reviewed 12,304 patients with cancer, 19% with OV, 29% with PANC, 13% with CRC <50, 2% with ENDO <50, 26% with BR ≤50, and 9% with MULTI. Of all patients, GGT was not covered for 31%, including 29% of OV, 27% of PANC, 35% of CRC <50, 39% of ENDO <50, 35% of BR ≤50, and 27% of MULTI. Of all cases with no coverage for clinically indicated GGT, 30% had clinical denial codes (e.g. medical necessity, non-covered services, experimental), 68% had only technical denial codes, and 2% had no denial codes. Overall, appeals were successful in 32% of cases, including 27% of OV, 25% of PANC, 44% of CRC <50, 39% of ENDO <50, 33% of BR <50, and 22% of MULTI. The proportion of cases with coverage differed significantly by self-reported race and ethnicity (58%-81%, p <0.00001), with Black and Hispanic individuals being less likely to be covered in comparison to Ashkenazi Jewish, Asian, and White individuals. Whereas the proportion of those receiving denial codes differed between self-reported race and ethnicity groups (p <0.00001), the percentages of technical vs. clinical denial codes received did not (p = 0.56). Conclusions: Despite clinical guidelines and payer medical policy affirming the medical necessity of universal GGT in these cancer types, these data demonstrate that 30% of patients did not receive coverage for standard of care GGT, and was lower in traditionally under-represented groups. Denials overturned on appeal suggest those cases should not have been denied initially. These data suggest that coverage denials are a substantial obstacle to medically necessary GGT for patients with cancer despite clinical practice guidelines.