Genomic Medicine and Genetic Counseling in the Department of Veterans Affairs and Department of Defense
The following is a lightly edited transcript of a teleconference recorded in July 2019.
On the laboratory side, it has been a very interesting experience. Because we provide comprehensive germline cancer testing at very little cost to the provider at any MTF, we have had high numbers of test requests over the years.
In addition to saving the DoD millions of dollars in testing, we have learned some interesting lessons in the process. For instance, we have worked closely with several different groups to better understand how to educate providers on the genetic counseling and testing process. This has allowed us to craft a thorough and inclusive consent form that addresses the needs of the DoD. We have also learned valuable lessons about population-based screening vs evidence-based testing, and lessons surrounding narrow-based testing (BRCA1 and BRCA2 only testing) vs ordering a more comprehensive panel that includes other genes supported by strong evidence (such as PALB2, CHEK2, or TP53).
For example, we have found that in a significant proportion of individuals with and without family history, there are clinically relevant variants in genes other than BRCA1 or BRCA2. And so, we have made part of our consent process,
a statement on secondary findings. If the patient consents, we will report pathogenic variants in other genes known to be associated with cancer (with strong evidence) even if the provider ordered a narrow panel such as BRCA1 and BRCA2 testing only. In about 1% to 4% of patients that would otherwise not meet NCCN guidelines, we’ve reported variants that were clinically actionable and changed the medical management of that patient.
We feel strongly that this is a conversation that we need to have in our field, and we realize it’s a complex issue, maybe we need to expand who gets testing. Guideline based testing is missing some patients out there that could benefit from it.
Vickie Venne. There certainly are many sides to the conversation of population-based vs evidence-based genetic testing. Genetic testing policies are changing rapidly. There are teams exploring comprehensive gene sequencing for
newborns and how that potential 1-time test can provide information will be reinterpreted as a person goes from cradle to grave. However, unlike the current DoD process, in the VA there are patients who we don’t see.
Renee Rider. I want to talk about money. When we order a genetic test, that test is paid for by the pathology department at the patient’s VAMC. Most of the pathology departments we work with are clear that they only can provide
genetic testing that is considered medically necessary. Thus, we review each test to make sure it meets established guidelines for testing. We don’t do population genetic screening as there isn’t evidence or guidelines to support offering it. We are strict about who does and does not get genetic testing, partly because we have a responsibility to pathology departments and to the taxpayers.
GMS focuses on conditions that are inherited, that is to say, we deal with germline genetics. Therefore, we discontinue referrals for somatic requests, such as when an OncotypeDX test is requested. It is my understanding that pharmacogenetic referrals may be sent to the new PHASeR initiative, which is a joint collaboration between the VA and Sanford Health and is headed by Deepak Voora, MD.
We generally don’t see patients who still are having diagnostic procedures done. For example, if a veteran has a suspicious breast mass, we recommend that the provider workup the mass before referring to GMS. Regardless of a genetic test result, a suspicious mass needs to be worked up. And, knowing if the mass is cancerous could change how we would proceed with the genetic workup. For example, if the mass were not cancerous, we may recommend that an affected relative have the first genetic evaluation. Furthermore, knowing if the patient has cancer changes how we interpret negative test results.
Another group of patients we don’t see are those who already had genetic testing done by the referring provider. It’s a VA directive that if you order a test, you’re the person who is responsible for giving the results. We agree with
this directive. If you don’t feel comfortable giving back test results, don’t order the test. Often, when a provider sends a patient to us after the test was done, we discover that the patient didn’t have appropriate pretest counseling. A test result, such as a variant of uncertain significance (VUS), should never be a surprise to either the provider or the patient.
Ishta Thakar. For newly diagnosed cancers, the first call is to the patient to inform them that they have cancer. We usually bring up genetic counseling or testing, if applicable, when they are ready to accept the diagnosis and have a conversation about it. All our consults are via telehealth, so none of our patients physically come to GMS in Salt Lake City. All the consults are done virtually.
For newly diagnosed patients, we would send a consult in within a couple of weeks. For patients who had a family history, the referral would not be urgent: They can be seen within about 3 months. The turnaround times for GMS are so much better than what we have available in the community where it’s often at least 6 months, as previously noted.
