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Laboratory business models and practices: implications for availability and access to germline genetic testing
PURPOSE: Germline testing laboratories have evolved over several decades. We describe laboratory business models and practices and explore their implications on germline testing availability and access. METHODS: We conducted semistructured interviews with key informants using purposive sampling. We...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group US
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8460432/ https://www.ncbi.nlm.nih.gov/pubmed/33958748 http://dx.doi.org/10.1038/s41436-021-01184-z |
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author | Scheuner, Maren T. Douglas, Michael P. Sales, Paloma Ackerman, Sara L. Phillips, Kathryn A. |
author_facet | Scheuner, Maren T. Douglas, Michael P. Sales, Paloma Ackerman, Sara L. Phillips, Kathryn A. |
author_sort | Scheuner, Maren T. |
collection | PubMed |
description | PURPOSE: Germline testing laboratories have evolved over several decades. We describe laboratory business models and practices and explore their implications on germline testing availability and access. METHODS: We conducted semistructured interviews with key informants using purposive sampling. We interviewed 13 key informants representing 14 laboratories. We used triangulation and iterative data analysis to identify topics concerning laboratory business models and practices. RESULTS: We characterized laboratories as full-service (FSL), for-profit germline (PGL), and not-for-profit germline (NGL). Relying on existing payer contracts is a key characteristic of the FSL business models. FSLs focus on high-volume germline tests with evidence of clinical utility that have reimbursable codes. In comparison, a key business model characteristic of PGLs is direct patient billing facilitated by commodity-based pricing made possible by investors and industry partnerships. Client billing is a key business model characteristic of NGLs. Because many NGLs exist within academic settings, they are challenged by their inability to optimize laboratory processes and billing practices. CONCLUSION: Continued availability of, and access to germline testing will depend on the financial success of laboratories; organizational characteristics of laboratories and payers; cultural factors, particularly consumer interest and trust; and societal factors, such as regulation and laws surrounding pricing and reimbursement. |
format | Online Article Text |
id | pubmed-8460432 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Nature Publishing Group US |
record_format | MEDLINE/PubMed |
spelling | pubmed-84604322021-10-07 Laboratory business models and practices: implications for availability and access to germline genetic testing Scheuner, Maren T. Douglas, Michael P. Sales, Paloma Ackerman, Sara L. Phillips, Kathryn A. Genet Med Article PURPOSE: Germline testing laboratories have evolved over several decades. We describe laboratory business models and practices and explore their implications on germline testing availability and access. METHODS: We conducted semistructured interviews with key informants using purposive sampling. We interviewed 13 key informants representing 14 laboratories. We used triangulation and iterative data analysis to identify topics concerning laboratory business models and practices. RESULTS: We characterized laboratories as full-service (FSL), for-profit germline (PGL), and not-for-profit germline (NGL). Relying on existing payer contracts is a key characteristic of the FSL business models. FSLs focus on high-volume germline tests with evidence of clinical utility that have reimbursable codes. In comparison, a key business model characteristic of PGLs is direct patient billing facilitated by commodity-based pricing made possible by investors and industry partnerships. Client billing is a key business model characteristic of NGLs. Because many NGLs exist within academic settings, they are challenged by their inability to optimize laboratory processes and billing practices. CONCLUSION: Continued availability of, and access to germline testing will depend on the financial success of laboratories; organizational characteristics of laboratories and payers; cultural factors, particularly consumer interest and trust; and societal factors, such as regulation and laws surrounding pricing and reimbursement. Nature Publishing Group US 2021-05-06 2021 /pmc/articles/PMC8460432/ /pubmed/33958748 http://dx.doi.org/10.1038/s41436-021-01184-z Text en © This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Scheuner, Maren T. Douglas, Michael P. Sales, Paloma Ackerman, Sara L. Phillips, Kathryn A. Laboratory business models and practices: implications for availability and access to germline genetic testing |
title | Laboratory business models and practices: implications for availability and access to germline genetic testing |
title_full | Laboratory business models and practices: implications for availability and access to germline genetic testing |
title_fullStr | Laboratory business models and practices: implications for availability and access to germline genetic testing |
title_full_unstemmed | Laboratory business models and practices: implications for availability and access to germline genetic testing |
title_short | Laboratory business models and practices: implications for availability and access to germline genetic testing |
title_sort | laboratory business models and practices: implications for availability and access to germline genetic testing |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8460432/ https://www.ncbi.nlm.nih.gov/pubmed/33958748 http://dx.doi.org/10.1038/s41436-021-01184-z |
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