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Comment: The applicant commented that CMS assigned a $0.00 device offset amount associated with the device pass-through payment for the original (lumbar-specific) aprevo and requested that CMS be consistent with this policy determination and assign a $0.00 to the aprevo Cervical ACDF System device pass-through payment

In the absence of safety data, most clinicians advise that pregnant or breastfeeding individuals avoid this compounded preparation unless the anticipated benefit clearly outweighs theoretical fetal or neonatal risks

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Research indicates that modulation of upstream growth hormone pathways may intersect with insulin signaling networks, hepatic regulatory pathways, and glucose-associated metabolic processes