Methane Breath testing

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Good Afternoon,


I have been asked by a GI clinic what they need to do to start performing methane breath testing in regards to CLIA regulation.  Does anyone know if this is considered a POCT based on specimen type?  I am having trouble finding information on this.


Thank you

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Breath is not considered a specimen by CMS


It is covered by CLIA if you collect  physical sample from a patient,  do tests on it, report it  in the EMR and bill for it.


Breath methane or breath alcohol are not POC tests.


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Pamela Kelsea
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