When the Seattle Children’s Hospital stewardship program launched in 2012, all testing related to cancer was excluded from review given its complex, time-sensitive, and critical nature. However, with the increase in availability of molecular tumor next-generation sequencing (NGS) panels, we could no longer ignore this testing domain. We learned that there are unique considerations for biomarker testing review that can present challenges to standard stewardship strategies (Table 1).
By 2016, we expanded our insurance preauthorization policy scope and test review criteria to include tumor NGS panels. This required a dedicated integrated system of pathologist review and laboratory genetic counselor support to adequately assess clinical utility, test selection, and specimen criteria and navigate insurance preauthorization nuances.
At that time, the bulk of testing served patients with central nervous system (CNS) tumors based on the available evidence, including the 2016 World Health Organization (WHO) Classification of CNS tumors, which required molecular testing for the diagnosis of many CNS tumor types.
We formed a monthly molecular brain tumor board, consisting of neuro-oncology, pathology, molecular pathology, genetic counseling, neurosurgery, and a research coordinator to review results. This group also dealt with ordering and insurance logistics, and it facilitated several research projects that informed internal ordering pathways for clinical and research tumor testing. We also used data from this work to justify institutional support for an integrated genetic counselor in the multidisciplinary neuro-oncology clinic.
As the stewardship program evolved, so did the number of available testing options and indications in oncology. From 2017 to 2019 we began triaging minimal residual disease (MRD) testing requests, developed DNA/RNA testing protocols in patients with acute myeloid leukemia and acute lymphoblastic leukemia, and guided the transition from research to clinical testing across all cancer types.
We also created molecular tumor boards for hematologic malignancies and non-CNS solid tumors. Like the molecular brain tumor board, these meetings were led by stewardship pathologists and included lab genetic counselors.
The release of the 2021 edition of the WHO Classification of CNS tumors prompted a new strategy to support the increase in testing volume and options. By this time, all miscellaneous genetic tests from hematology-oncology and any defined single gene or panel order underwent stewardship review. We observed an increase of approximately 300% in oncology preauthorization requests from 2016−2023 (Figure 1).
Stewardship Strategies―A "Yes, And" Approach
There might not be a more perfect pair than a pathologist and a lab genetic counselor to lead oncology test stewardship efforts. As a first step, identify your champions. Collaboration with oncology providers and pathologists was critical to our program’s success. If there are tumor boards at your institution, ask to be on the invite list. If molecular tumor boards don’t exist, start one! Also born from the complexities of precision oncology care is a similar role to the lab steward, commonly referred to as a precision medicine steward or biomarker navigator (3). This emerging role will offer lab stewardship programs more opportunities for collaboration in the future.
Below I’ll address a few of the considerations unique to stewardship of biomarker testing.
Urgency
Yes, testing is urgent — and there are opportunities to obtain preauthorization to protect the patient and institution financially. There often is time to process an insurance preauthorization while performing other first-line therapies or imaging. Education and collaboration are key, and once scenarios such as these have been identified, hospitals can implement processes to support preauthorizations and prevent orders from falling through the cracks. Documenting the recommended preauthorization and testing plan in the tumor board summary supports care teams in executing next steps.
And, when in doubt, send it out! Like other institutions, we have recently transitioned biomarker test ordering from the provider to the pathologist in cases where the results are needed to confirm diagnosis that cannot be made from radiography or histopathology alone (2). In these cases, there is no time to wait for preauthorization; however, stewardship interventions are still important. Templates allow pathologists to take ownership of documenting medical necessity within the preliminary pathology report and the integrated molecular diagnosis in the final report. This documentation may be useful for a patient’s future testing and may be needed at the time of insurance claims review.
“Repeat” Testing
MRD monitoring is difficult to preauthorize and track. Yes, this testing typically requires insurance preauthorization like other genetic testing, and there are many tools you can implement to make this less painful. For example, consider using a tracking database that allows for easily viewing order dates of service and prior preauthorization requests. Create Epic SmartPhrases or templates to submit MRD preauthorization requests to the payor and your insurance processing team so they know the request is not a duplicate. Defining these orders in the electronic medical record can help streamline billing workflows.
Templates help with other situations as well. As a stewardship consultant reviewing the same test on a patient, it can be challenging to determine testing rationale each time. We helped develop medical necessity and testing plan templates and shared them with the ordering teams. Now, a quick look at a single note gives us details to efficiently triage the order.
Implications for Inherited Cancer Risk
The potential for identifying germline variants from biomarker testing raises additional considerations for the stewardship process, including pre-test counseling, sample requirements, and order details. We leveraged the relationship between our stewardship lab genetic counselor and oncology department to create two embedded clinical genetic counselor positions within hematology-oncology and collaborate to align clinical practice with lab stewardship philosophies.
Conclusion
To borrow a phrase from Taylor Swift, cancer is in its molecular diagnostics era. We need to shake it off (the past, that is) and embrace new models of stewardship interventions and strategies for biomarker test coordination. Pathologists are now directly involved in the ordering of molecular testing: This practice change is a perfect opportunity for stewardship team engagement to guide new workflows, and ensure patients get the right test, even in a time crunch.
“In recent years, there has been a revolution in our knowledge of the genetic drivers of pediatric cancer,” said Bonnie Cole, MD, a pathologist and clinical assistant professor at Seattle Children’s. “It is now our job to use this knowledge to precisely tailor diagnosis and treatment for every single one of our patients.”
Another colleague, Sarah Leary, MD, MS, an attending physician and medical director of the pediatric brain tumor program at Seattle Children’s, underscored the need for teamwork. “For practicing oncologists, collaboration with laboratory medicine is crucial to understanding the implications as well as limitations of ever evolving testing options.”
I encourage lab stewardship teams to remain flexible, count the small wins, when in doubt send it out, and acknowledge that a one-size-fits all approach will not be successful.
References
1. Consistent Testing Terminology Working Group. A white paper on the need for consistent terms for testing in precision medicine. https://www.preventcancer.org/wp-content/uploads/2020/09/Consistent_Testing_Terminology_Whitepaper_V7.pdf (Accessed February 2024).
2. Viaene AN. Pediatric brain tumors: A neuropathologist's approach to the integrated diagnosis. Front Pediatr 2023; doi.org/10.3389/fped.2023.1143363.
3. Association of Community Cancer Centers. Precision medicine stewardship: A model from Astera Cancer Care. http://accc-cancer.org/precision-medicine-stewardship (Accessed February 2024).
Shannon Stasi, MS, LCGC, is a genetic counselor at Seattle Children’s Hospital in the department of laboratories and with PLUGS in Seattle, Washington. +Email: [email protected]