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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

Bian W, Wei L, Wang K

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Most patients see measurable lipotropic results after 4 weeks of consistent weekly use