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Payer reimbursement practices and incentives for improving interpretation of germline genetic testing

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 laborator...

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Autores principales: Deverka, Patricia, Geary, Janis, Mathews, Charles, Cohen, Matan, Hooker, Gillian, Majumder, Mary, Skvarkova, Zuzana, Cook-Deegan, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332933/
https://www.ncbi.nlm.nih.gov/pubmed/37435610
http://dx.doi.org/10.1093/jlb/lsad020
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author Deverka, Patricia
Geary, Janis
Mathews, Charles
Cohen, Matan
Hooker, Gillian
Majumder, Mary
Skvarkova, Zuzana
Cook-Deegan, Robert
author_facet Deverka, Patricia
Geary, Janis
Mathews, Charles
Cohen, Matan
Hooker, Gillian
Majumder, Mary
Skvarkova, Zuzana
Cook-Deegan, Robert
author_sort Deverka, Patricia
collection PubMed
description 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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spelling pubmed-103329332023-07-11 Payer reimbursement practices and incentives for improving interpretation of germline genetic testing Deverka, Patricia Geary, Janis Mathews, Charles Cohen, Matan Hooker, Gillian Majumder, Mary Skvarkova, Zuzana Cook-Deegan, Robert J Law Biosci Original Article 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. Oxford University Press 2023-07-09 /pmc/articles/PMC10332933/ /pubmed/37435610 http://dx.doi.org/10.1093/jlb/lsad020 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Deverka, Patricia
Geary, Janis
Mathews, Charles
Cohen, Matan
Hooker, Gillian
Majumder, Mary
Skvarkova, Zuzana
Cook-Deegan, Robert
Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
title Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
title_full Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
title_fullStr Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
title_full_unstemmed Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
title_short Payer reimbursement practices and incentives for improving interpretation of germline genetic testing
title_sort payer reimbursement practices and incentives for improving interpretation of germline genetic testing
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10332933/
https://www.ncbi.nlm.nih.gov/pubmed/37435610
http://dx.doi.org/10.1093/jlb/lsad020
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