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We also proposed that if the calculated percentile falls between two observed allowed amounts, the 10th percentile allowed amount is the next highest observed value

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The first criterion, at 419.66(c)(1), provides that CMS determines that a device to be included in the category is not appropriately described by any of the existing categories or by any category previously in effect, and was not paid for as an outpatient service as of December 31, 1996