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For example, where there are a variety of devices, drugs, items, and supplies that could be used to furnish a service, some of which are more costly than others, packaging encourages hospitals to use the most cost-efficient item that meets the patient's needs, rather than to routinely use a more expensive item, which may occur if separate payment is provided for the item

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Timing Optional Monitoring is pathway-based because BPC-157 and TB-500 have limited human safety data and no established clinical lab-monitoring protocol

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The third criterion for establishing a device category, at 419.66(c)(3), requires CMS to determine that the cost of the device is not insignificant, as described in 419.66(d)