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With respect to the exclusion criteria at 419.66(b)(4), a device is not eligible to be considered for pass-through payment if it is any of the following: (1) equipment, an instrument, apparatus, implement, or item of this type for which depreciation and financing expenses are recovered as depreciable assets as defined in Chapter 1 of the Medicare Provider Reimbursement Manual (CMS Pub

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Any diluent selection, preparation, temperature, aliquoting, or post-reconstitution hold conditions must be established by a qualified laboratory under a validated SOP