An important new paper is just released, and open access. See Pineualt et al., on protocols and barriers regarding reflex testing for gene panels in non small cell lung cancer (NSCLC).
Find it here:
https://pubmed.ncbi.nlm.nih.gov/42467547/
i've linked via PubMed which gives you, at bottom, a useful list of related papers.
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AI CORNER
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What Happens After the Guideline? Achieving Access in Real-World Practice
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Pineault and colleagues examine how US health care institutions actually implement comprehensive biomarker testing for non–small cell lung cancer—not simply whether professional guidelines recommend it. Using a national cross-sectional survey of 111 health care professionals involved in NSCLC testing, the study evaluates locally standardized protocols, reflex ordering of broad multigene panels, the role of pathologists, and the regulatory and operational barriers encountered in everyday practice.
The findings are encouraging but reveal a striking implementation gap. Nearly 78% of respondents reported that their institutions had standardized comprehensive biomarker-testing protocols, and 88% of those protocols included reflexing to a multigene panel. At institutions with such protocols, most respondents said that at least 80% of newly diagnosed patients received comprehensive testing. Yet the proportion reporting that results were available before the first oncology visit—when first-line treatment is selected—fell to 47.7%. Thus, adopting a protocol does not automatically ensure that its intended clinical benefit reaches the patient at the critical decision point.
Pathologists were commonly the ordering providers, reflecting their practical position at the center of specimen selection, tumor assessment, tissue stewardship, and testing logistics. More than 90% of respondents believed that multidisciplinary, pathologist-ordered reflex testing improves care, and 93.7% supported CMS recognition of pathologists as ordering physicians, generally within guideline-based or multidisciplinary safeguards.
The study’s greatest contribution may be its treatment of regulation as something institutions must operationalize rather than merely obey. Reimbursement restrictions, prior authorization, payer denials, the Medicare 14-day rule, differing Medicare Administrative Contractor requirements, staffing shortages, and LIS limitations all shaped how—or whether—reflex testing worked. Institutions consequently developed locally adapted arrangements involving pathologist orders, oncology standing orders, multidisciplinary approval, and other hybrid workflows.
This is an important and highly promising approach to health-policy research. By studying real-world institutions, it shows how regulatory policies are translated, negotiated, accommodated, and sometimes worked around inside functioning care systems. The survey is modest, self-reported, and weighted toward pathology professionals, so it cannot establish causality or national prevalence. Nevertheless, it provides precisely the kind of grounded institutional evidence needed to understand why apparently sound policies succeed in some settings but falter in others—and how regulation might be redesigned to support effective care rather than inadvertently obstruct it.
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About LUNGevity
The study was funded by LUNGevity Foundation, a leading US lung-cancer nonprofit supporting research, patient education, advocacy, and community services. Its precision-medicine initiatives promote timely, comprehensive biomarker testing and work to remove reimbursement, prior-authorization, and regulatory barriers that prevent patients from receiving the right treatment at the right time.
