Center for Medical Ethics and Health Policy Staff Publications

Publication Date

1-1-2023

Journal

Journal of Law and the Biosciences

DOI

10.1093/jlb/lsad020

PMID

37435610

PMCID

PMC10332933

PubMedCentral® Posted Date

7-9-2023

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

cancer, genetic testing, coverage, reimbursement, data sharing, precision medicine

Abstract

Germline genetic testing for inherited cancer risk has shifted to multi-gene panel tests (MGPTs). While MGPTs detect more pathogenic variants, they also detect more variants of uncertain significance (VUSs) that increase the possibility of harms such as unnecessary surgery. Data sharing by laboratories is critical to addressing the VUS problem. However, barriers to sharing and an absence of incentives have limited laboratory contributions to the ClinVar database. Payers can play a crucial role in the expansion of knowledge and effectiveness of genetic testing. Current policies affecting MGPT reimbursement are complex and create perverse incentives. Trends in utilization and coverage for private payers and Medicare illustrate opportunities and challenges for data sharing to close knowledge gaps and improve clinical utility. Policy options include making data sharing (i) a condition of payment, and (ii) a metric of laboratory quality in payment contracts, yielding preferred coverage or enhanced reimbursement. Mandating data sharing sufficient to verify interpretations and resolve discordance among labs under Medicare and federal health programs is an option for the US Congress. Such policies can reduce the current waste of valuable data needed for precision oncology and improved patient outcomes, enabling a learning health system.

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