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Factor in physician consultation fees, lab monitoring costs, and shipping charges when comparing total therapy expenses

the FDA approved the first such drug, exenatide, in 2005

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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))