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Section 419.47 is amended by revising the section heading and paragraph (a) and to read as follows: Coding and payment for Category B Investigational Device Exemption (IDE) studies

Certified Reference Material Levocarnitine is indicated for treatment of primary systemic carnitine deficiency, a genetic impairment of normal biosynthesis or utilization of levocarnitine from dietary sources, or for the treatment of secondary carnitine deficiency resulting from an inborn error of metabolism

other than direct blockade by a DAT inhibitor) to regulate the activity of DAT and dopaminergic neurotransmission, and a potential target site for future development of ADHD treatments

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