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It means we obtained the vendor's third-party Certificate of Analysis, confirmed the testing laboratory and matched it to the batch currently being sold

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For purposes of this paragraph (d)(2), the most recent 12-month period for which data are available means the most recent 12-month period for which the data source used contains all data from the requesting hospital and each other hospital that has a Medicare participation agreement with CMS and is located in the county in which the requesting hospital is located