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As part of this revised definition of primary care services used for assigning beneficiaries at 425.402, we proposed to incorporate a provision at 425.400(c)(1)(x)(C), specifying that the primary care service codes for purposes of assigning beneficiaries include a CPT code identified by CMS that directly replaces a CPT code specified at 425.400(c)(1)(x)(A) or a HCPCS code specified at 425.400(c)(1)(x)(B), when the assignment window or expanded window for assignment (as defined at 425.20) for a benchmark or performance year includes any day on or after the effective date of the replacement code for payment purposes under Medicare FFS

While more large-scale human studies are needed, current research and clinical use suggest that BPC-157 is well tolerated and low-risk when used under medical supervision