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and (3) the difference between the estimated average reasonable cost of the devices in the category and the portion of the APC payment amount for the device exceeds 10 percent of the APC payment amount for the related service (with the exception of brachytherapy and temperature-monitored cryoablation, which are exempt from the cost requirements as specified at 419.66(c)(3) and (e))

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)