An effective and multidisciplinary utilization framework for esoteric/ referred tests in molecular pathology

Document Type

Conference Proceeding

Publication Date


Publication Title

Lab Invest


Background: In the emerging Value-Based Payment healthcare model, Pathology's governance of referral (send-out) testing is a prime opportunity to demonstrate domain expertise and reduce costs. However, in the absence of an institutional governance mechanism, pathologists have limited influence on utilization of novel, expensive, and esoteric molecular genetic tests. This unchecked utilization may place undue financial burden on the laboratory. To overcome these challenges, we designed and deployed a multidisciplinary and collaborative framework to ensure cost-effective and medically relevant utilization. Design: We approached our institutional apex governance council and chartered an executive-level Medical Laboratory Formulary (MLFC) to govern the laboratory utilization framework for the entire health system. Clinical Evaluation and Technical Assessment Committee (CETAC), an MLFC subcommittee, is led by Pathology's Vice-Chair. It comprises of pathologists, clinical scientist, laboratory administrators, and representatives from billing and specimen handling. A specified workflow was developed to perform an exhaustive medical, scientific and operational analysis including (1) FDA Clearance (2) National Guidelines (3) Impact on diagnosis/treatment (4) Test cost (5) Coverage by insurance carriers. Subsequently, CETAC invited clinician experts. Based on their input and (1-5), utilization parameters were defined as (a) No restrictions (b) Available after medical review and (c) Off-formulary (i.e. not available through laboratory's referral channels). Results: In total, 14 germline and nine somatic testing requests were reviewed over 33 CETAC meetings. The final utilization parameters were: No restriction (n=0), Available after medical review by CETAC expert (n=8), and Off-formulary (n=15). For individual tests within the medical review category, utilization was limited to four medical specialties (Genetics, Transplant, Neurology and Oncology). The prices of these requests ranged from $50- $5800. A distinct Off-formulary ordering pathway was created for patients or providers still wishing to access such tests. MLFC endorsed 22/23 CETAC determinations and revised only one. Conclusions: CETAC has been successful because of its inclusive nature, well-defined pathways and deriving its legitimacy under system-level MLFC. We have managed to deploy an objective and cost-effective utilization framework. Through its work, it has provided an effective and visible role to pathologists. Based on our experience, we highly recommend deploying similar frameworks at other Pathology departments.



First Page


This document is currently not available here.