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The second cost significance requirement, at 419.66(d)(2), provides that the estimated average reasonable cost of the devices in the category must exceed the cost of the device-related portion of the APC payment amount for the related service by at least 25 percent, which means that the device cost needs to be at least 125 percent of the offset amount (the device-related portion of the APC found on the offset list)

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H., Yang, T

Clinical studies used 0.5-2% solutions applied directly to clean, dry scalp nightly with 2-3 minute massage and no rinsing