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LUNGevity Precision Medicine Summit: Improving Biomarker Testing

By Molly Kisiel, MSN, FNP-BC

April 16, 2024
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The LUNGevity Lung Cancer Precision Medicine Summit held on March 13, 2024, in Washington, DC, addressed critical issues surrounding biomarker testing in non-small cell lung cancer. In past summits, initiatives and partnerships emerged that aimed to standardize testing practices and increase access to comprehensive biomarker testing. This year, LUNGevity looked to develop strategies for expanding biomarker testing in patients with non-small cell lung cancer. Three primary areas of focus included the development of a joint National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) consensus statement on biomarker testing; reflex testing workflows and reimbursement tools, and a value proposition to key hospital stakeholders.

Consensus Statement

LUNGevity is working with guidelines experts from NCCN and ASCO to draft a consensus statement that summarizes recommendations for biomarker testing in non-small cell lung cancer. The statement—targeted at payer and provider communities—would stress the significance of universal access to biomarker testing—regardless of socioeconomic status or geographical barriers—for all people with non-small cell lung cancer. Inconsistency and ambiguity in ASCO/NCCN biomarker testing guidelines recommendations could serve as a reason for a payer to avoid paying for a broad multi-gene biomarker test (eg inconsistent use of testing terms, differences in panel size recommendations, ambiguity of recommendation). Thus, a consensus statement could positively impact payer and provider understanding of the guidelines. Improved payer comprehension of the guidelines recommendations for biomarker testing could ultimately improve coverage policies for patients.

Reflex Testing

Rethinking biomarker testing as reflex testing is a significant endeavor. Participants envisioned that all patients newly diagnosed with lung cancer should have a workup that includes molecular analysis for biomarkers to render a complete diagnosis. Maintaining this approach in a generalized manner rather than categorizing testing by specific cancer types, could aid community pathologists with limited resources in identifying cases suitable for biomarker testing. Discussions revolved around implementing standing orders for reflex testing and introducing precision medicine navigators. However, barriers emerged including the increased burden on medical oncologists to manage the orders requiring a signature and the influx of results. Additionally, there was apprehension regarding the responsibility for payment if testing is not covered.

Attendees believed the concept of precision medicine navigators would need to be tailored to individual institutions, as it is not typically a revenue-generating role, although this may change with the implementation of new Center for Medicare & Medicaid Services (CMS) codes. Consequently, institutions with limited resources might struggle to establish a standalone precision medicine navigator program.

The conversation also touched upon the current practice of ordering reflex testing based on the cancer stage. Per Summit participants, ideally, all patients with non-small cell lung cancer should undergo testing. However, inconsistencies in coverage contribute to a fragmented process, with concerns about who bears the responsibility for payment. It is also important to consider not only the financial burden on patients but also on smaller community cancer programs and practices, that may struggle to cover the costs. Discussion revolved around the absence of provisions in current legislation to enforce payer compliance, leaving the issue unresolved if payers are non-compliant. A suggestion emerged for the establishment of a "report card" for payers, potentially involving collaboration with insurance commissioners, to enhance coverage and enable providers to adhere to the highest standards of practice.

Currently, according to CMS guidelines, pathologists are not considered part of the treatment team. However, attendees unanimously agreed that enabling pathologists to directly order reflex testing at the same time the initial diagnosis is received would greatly enhance the workflow and the testing process. However, questions remain regarding the enactment of such a measure, specifically ensuring that patients have an active treatment team if they are treated outside of the pathologist's facility.

There may also be variations in the severity of barriers across institutions, suggesting that any implemented process would need to be tailored to individual programs rather than adopting a standardized approach nationally. However, one potential opportunity that emerged is the consideration for a quality improvement initiative, as part of Commission on Cancer accreditation, to evaluate barriers and opportunities for expanding reflex testing.

Value Proposition

The focus of the value proposition group was ensuring consistent communication by industry representatives with all hospital and health care system stakeholders involved in decision-making for improvements in precision medicine processes. These stakeholders include not only C-Suite executives, such as CEOs and chief medical officers, but also administrators and others overseeing cancer service lines. Most importantly, attendees argued that messaging directed towards each stakeholder group should align with their respective priorities.

For senior-level C-Suite executives, discussions should emphasize the allocation of funds; adherence to national guidelines; and the potential for improved outcomes, enhanced quality of life, and reduced disparities resulting from implementation. Conversations with cancer service line administrators should prioritize the importance of conducting comprehensive testing at the time of diagnosis to deliver optimal care while minimizing toxicities. Additionally, the optimization of electronic health records should be addressed with both stakeholder groups to streamline workflows effectively.

Looking Forward

It is important to recognize that biomarkers play a dual role, aiding both in prognosis and confirming diagnoses, especially in cases of metastatic disease. Additionally, biomarker testing can pinpoint patients who might require less aggressive therapy, allowing for treatment de-escalation. The day’s discussions emphasized the urgent need for equitable access to biomarker testing for all patients with non-small cell lung cancer, with a primary focus on enhancing patient outcomes and mitigating disparities in care.

Molly Kisiel, MSN, FNP-BC is director, Clinical Content, Editorial Content and Strategy, Association of Cancer Care Centers, Rockville, Maryland. 

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