Genetic Counseling Prerequisite Reduced Appropriate Testing, Study Finds

A new study in the Journal of Oncology Practice has found that the health plan requirement of counseling by certified geneticists could have led to patient access issues in oncology.
Published Online: November 04, 2016
Surabhi Dangi-Garimella, PhD

In the world of precision medicine and targeted therapies, genetic testing to identify the appropriate treatment option has become the norm. However, some of these treatments are expensive, and using a targeted drug without the relevant mutation could be a mistake—both clinically and financially. To circumvent this issue, health plans integrated a genetic counseling requirement prior to a patient being prescribed precision treatment. Now, a new study in the Journal of Oncology Practice (JOP) has found that this requirement could have led to patient access issues.

The authors wrote that several professional medical societies offer pretest assessment and counseling to ensure appropriate testing and informed consent; continued education programs offered by these societies ensure members are up-to-date on advances in the field. However, there was a push by certain organizations that risk assessment should only be performed by licensed geneticists, and one national health plan—which the authors did not name in the paper—incorporated a policy of testing only by geneticists, certified genetic counselors, or a third-party approval process via telephone.

To identify the impact of such policies, the authors of this retrospective study in JOP evaluated the laboratory database of Myriad Genetic Laboratories to identify the number of comprehensive BRCA1/2 genetic tests ordered and completed between September 2012 and December 2014. While identifying patient information was not included in the analysis, clinical information collected as part of normal testing procedures was. The primary outcomes being studied were test cancellation rates (tests ordered that did not result in a reported test result), mutation-positive rates, and turnaround times for comprehensive BRCA1/2 testing for that specific health plan. The comparator group was a control national health plan.

The authors found that the study cancellation rate increased from 13.3% to 42.1% following policy implementation (P <.001). Even when a narrower group of individuals was considered—those who met the National Comprehensive Cancer Network criteria for hereditary breast and ovarian cancer testing—the cancellation rate increase was sustained. A racial bias was evident, as well: individuals with African American and Latin American ancestry presented with nearly 50% cancellation rates while those with a European heritage lingered around 34%.

The authors concluded that an insurance mandate to employ a physician geneticist or certified genetic counselor to approve a test for hereditary cancers results in a significant rise in test cancellation rates among those who qualify as ideal candidates to be tested for those specific mutations. The authors are particularly concerned with the impact of these rules on minority populations, as this would add to existing access barriers for these individuals.

Reference

Whitworth P, Beitsch P, Arnell C, et al. Impact of payer constraints on access to genetic testing [published online October 23, 2016]. J Oncol Pract. doi: 10.1200/JOP.2016.013581.



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