Steep Increases in Genetic Test Cancellations Seen Following Mandated Genetic Counseling

Insurance-mandated genetic counseling prior to hereditary cancer genetic testing significantly increased test cancellation rates, particularly among minority patients, according to research published in Journal of Oncology Practice.

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The researchers did not observe a correlation between increased cancellation and decreases in inappropriate testing, results showed.

The demand for genetic testing for hereditary breast and ovarian cancer has risen sharply since the identification of inherited deleterious mutations, such as BRCA1 and BRCA2. Genetic counseling and risk assessment prior to genetic testing is recommended by all related medical societies, which led one large national health care insurance payer to institute a policy requiring all patients to undergo genetic counseling prior to testing.

Peter Beitsch, MD, FACS, surgical oncologist at Dallas Surgical Group (Dallas, TX), and colleagues hypothesized that insurance-mandated genetic counseling would cause a reduction in receipt of appropriate genetic testing. The researchers accessed data from Myriad Genetics Laboratories (Salt Lake City, UT) for individuals for whom a comprehensive BRCA1/2 test was ordered in the 12-month period before (n = 6543) or after (n = 5834) the policy change. The study further included data from a control group with similar geographic coverage and testing requirements.

Dr Beitsch and colleagues defined test cancellation as a provider-ordered test without a recorded test result after a minimum of 6 months. Test appropriateness was determined based on whether self-reported personal and familial cancer histories met National Comprehensive Cancer Network (NCCN) guidelines for BRCA1/2 testing. The researchers conducted subgroup analyses based on the most commonly reported ancestries in the cohort, which included Western European, African, and Latin American/Caribbean, as well as for three commonly observed Ashkenazi Jewish founder mutations.

Test cancellations significantly rose following the implementation of mandated genetic counselling, from 13.3% (n = 867) in the 12-month period prior to implementation to 42.1% (n = 2456) in the 12-month period following implementation (P < .001). Contrastingly, cancellations rates in the control group declined in the same period, from 12.6% to 8.6% (P < .001).

These increases persisted when the researchers restricted their analysis to individuals who met the NCCN guidelines for genetic testing. Cancellation rates in this cohort rose from 9.5% prior to the policy change to 37.7% following the policy change (P < .001). The increase remained significant for individuals meeting the NCCN guidelines based on family history alone (prepolicy vs postpolicy, 4.8% vs 16.1%; P < .001) and among women with a personal diagnosis of ovarian cancer (6.3% vs 29.9%; P < .001). By contrast, cancellation rates declined for all women in the cohort group, from 8.4% to 3.8%, as well as for women recommended for testing based on family history (3.9% vs 2.3%; P < .001) and women with ovarian cancer (4.9% vs 2.4%; P = .005).

Prior to the policy change, higher cancellation rates occurred among individuals of African ancestry (16.3%; 95% CI, 13.1-19.9) and Latin American ancestry (15.7%; 95% CI, 12.3-19.7) as compared with individuals of Western European ancestry (11.2%; 95% CI, 9.9-12.6). Across all ethnic categories, rates of cancellation increased in the wake of policy implementation. The increase appeared more pronounced among individuals of African (48.9%; 95% CI, 43.9-53.9) and Latin American ancestry (49.6%; 95% CI, 44.6-54.7) than among individuals of Western European ancestry (33.9%; 95% CI, 31.6-36.2). In contrast, the control arm saw test cancellations decrease among all ethnic categories, although cancellations increased for Ashkenazi Jewish founder mutation tests in both the mandated testing group (3.5% vs 17.9%; P < .001) and the control group (3% vs 4.4%; P = .018).

“In an era when precision medicine strategies are evolving daily, misallocation of genetic counseling services, and implementation of policies that require genetic counselor approval for all hereditary cancer genetic testing serve not only as barriers to care for patients today but as barriers to the advancement of the state of the art of cancer care tomorrow,” Dr Beitsch and colleagues wrote.