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All clinical decisions regarding patient eligibility, dosing, monitoring, and treatment should be made by a licensed healthcare provider based on the individual patients clinical presentation, medical history, and applicable standard of care

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As indicated in the revised Medicare Part B Drug Inflation Rebate Guidance, the revised Medicare Part D Drug Inflation Rebate Guidance, and this final rule, CMS may consult with FDA for technical assistance in implementing the severe supply chain disruption and likely shortages provisions, as needed

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