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10.1016/j.regpep.2009.11.012 72 TurkovicB.SikiricP.SeiwerthS.MiseS.AnicT.PetekM.et al (2004)

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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