Perspectives on barriers to timely biomarker testing in NSCLC: Implications for care.

51 Background: Timely biomarker testing is essential for guiding treatment in non–small cell lung cancer (NSCLC). Reflex biomarker testing, ordered by pathologists, integrates biomarkers into the diagnostic process. However, CMS policies, particularly the 14-Day Rule and lack of clarity on ordering authority, limit the use of reflex testing, disrupting standardized workflows and delaying care. This study explores how these policies affect cancer care delivery. Methods: In early 2025, LUNGevity Foundation, with the Association for Molecular Pathology and the American Society for Clinical Pathology, surveyed 115 healthcare professionals to determine the prevalence of standardized workflows, pathologist-ordered biomarker testing, and application of the 14-Day Rule. Results: Findings indicate strong support for pathologist-ordered biomarker testing for reflex testing and timely diagnosis. Most respondents (94%) agreed CMS should recognize pathologists as ordering physicians, with 49% preferring this recognition be provided through guidelines. The majority (74%) strongly agreed this change would improve patient care. Standardized protocols - especially with in-house testing - were more common when pathologists ordered biomarker testing. Yet at 42% of sites using or considering such protocols, pathologists were not the ordering physician. Among these, 57% wanted implementation guidance, and 46% sought regulatory or compliance clarity for how to implement pathologist-initiated testing. Application of the 14-Day Rule varied: 22% applied it to inpatients, 13% to both inpatients and outpatients, and 23% were unsure. Regardless, 78% of those applying the 14-Day Rule said it caused treatment delays, and 40% reported treatment was selected before results were received. When asked how costs of multi-gene panels for in-patients with advanced-stage cancer are managed, 30% of respondents said the laboratory absorbs the cost, and 39% were unsure. Conclusions: Hospitals face the challenge of navigating regulations that impact care delivery - particularly the 14-Day Rule and unclear policies on pathologists' role in ordering biomarker panels, which influence implementation of reflex biomarker testing in the NSCLC diagnostic process. Respondents strongly supported pathologist-ordered testing as essential for reflex workflows and improved patient care. The 14-Day Rule was cited as a barrier to timely treatment, and a cause of financial strain when hospitals bypass the policy to expedite testing. Many were uncertain how testing costs are managed under current constraints, highlighting the need for clearer institutional policies. Hospital administrators should assess the impact of these regulations on care delivery and consider workflow adjustments in collaboration with pathology and oncology. Further research will gather broader input to guide recommendations to CMS, pathologists, and oncologists.