Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?

ABSTRACT Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection...

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Autores principales:	Peter H. Gilligan, Melissa B. Miller
Formato:	article
Lenguaje:	EN
Publicado:	American Society for Microbiology 2016
Materias:	Microbiology QR1-502
Acceso en línea:	https://doaj.org/article/35efcac025eb42a296f62b8089e17e92
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spelling	oai:doaj.org-article:35efcac025eb42a296f62b8089e17e922021-11-15T15:49:40ZWill Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?10.1128/mBio.02178-152150-7511https://doaj.org/article/35efcac025eb42a296f62b8089e17e922016-03-01T00:00:00Zhttps://journals.asm.org/doi/10.1128/mBio.02178-15https://doaj.org/toc/2150-7511ABSTRACT Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection are relatively insensitive. An innovative method for detecting these infections by using blood culture bottles (BCB) to culture specimens of periprosthetic tissue (PPT) was described in a recent article [T. N. Peel, et al., mBio 7(1):e01776-15, 2016, doi:10.1128/mBio.01776-15]. There are two potential stumbling blocks to the widespread implementation of this innovation. First, the FDA judges such an application of BCB as an “off-label use” and as such, a laboratory-developed test (LDT). LDTs are coming under greater scrutiny by the FDA and may require extensive, costly validation studies in laboratories that adopt this methodology. Second, the Center for Medicare and Medicaid Services has established a Hospital Acquired Condition Reduction Act under which institutions performing in the lowest quartile forfeit 1% of their Medicare reimbursement. Hospital-acquired infections are an important component of this quality metric. Although prosthetic joint infection (PJI) rates are not currently a hospital quality metric, given their cost and increasing frequency, it is reasonable to expect that they may become one. Will those with financial oversight allow an innovative technique that will require an expensive validation and may put the institution at risk for loss of CMS reimbursement?Peter H. GilliganMelissa B. MillerAmerican Society for MicrobiologyarticleMicrobiologyQR1-502ENmBio, Vol 7, Iss 1 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Microbiology QR1-502
spellingShingle	Microbiology QR1-502 Peter H. Gilligan Melissa B. Miller Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?
description	ABSTRACT Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection are relatively insensitive. An innovative method for detecting these infections by using blood culture bottles (BCB) to culture specimens of periprosthetic tissue (PPT) was described in a recent article [T. N. Peel, et al., mBio 7(1):e01776-15, 2016, doi:10.1128/mBio.01776-15]. There are two potential stumbling blocks to the widespread implementation of this innovation. First, the FDA judges such an application of BCB as an “off-label use” and as such, a laboratory-developed test (LDT). LDTs are coming under greater scrutiny by the FDA and may require extensive, costly validation studies in laboratories that adopt this methodology. Second, the Center for Medicare and Medicaid Services has established a Hospital Acquired Condition Reduction Act under which institutions performing in the lowest quartile forfeit 1% of their Medicare reimbursement. Hospital-acquired infections are an important component of this quality metric. Although prosthetic joint infection (PJI) rates are not currently a hospital quality metric, given their cost and increasing frequency, it is reasonable to expect that they may become one. Will those with financial oversight allow an innovative technique that will require an expensive validation and may put the institution at risk for loss of CMS reimbursement?
format	article
author	Peter H. Gilligan Melissa B. Miller
author_facet	Peter H. Gilligan Melissa B. Miller
author_sort	Peter H. Gilligan
title	Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?
title_short	Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?
title_full	Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?
title_fullStr	Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?
title_full_unstemmed	Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?
title_sort	will regulatory and financial considerations dampen innovation in the clinical microbiology laboratory?
publisher	American Society for Microbiology
publishDate	2016
url	https://doaj.org/article/35efcac025eb42a296f62b8089e17e92
work_keys_str_mv	AT peterhgilligan willregulatoryandfinancialconsiderationsdampeninnovationintheclinicalmicrobiologylaboratory AT melissabmiller willregulatoryandfinancialconsiderationsdampeninnovationintheclinicalmicrobiologylaboratory
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Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?

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