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( Have an average cost that is not insignificant relative to the payment amount for the procedure or service with which the device is associated as determined under 419.66(d) by demonstrating: (1) the estimated average reasonable cost of devices in the category exceeds 25 percent of the applicable APC payment amount for the service related to the category of devices

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Let's first look at the basic definitions of AHK-Cu and GHK-Cu: GHK-Cu (Glycyl-L-histidyl-L-lysine + Copper): A naturally occurring copper peptide found in human plasma and tissues