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It is crucial to distinguish between medically indicated B12 replacement therapy and commercially marketed wellness injections, as they serve fundamentally different purposes and are subject to different regulatory oversight

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Background The intent of transitional device pass-through payment, as implemented at 42 CFR 419.66, is to facilitate access for beneficiaries to the advantages of new and truly innovative devices by allowing for adequate payment for these new devices while the necessary cost data is collected to incorporate the costs for these devices into the procedure APC rate (66 FR 55861)

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