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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 being paid for as an outpatient service as of December 31, 1996

Among the five removed from Category 2 in September 2024 and now under PCAC review

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And it is going to impact the pituitary's release of growth hormone