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For monoclonal antibodies that are used for pre-exposure prophylaxis of COVID-19 that are covered and paid for under section 1861(s)(10) of the Act, we proposed to exclude these products from the definition of Part B rebatable drug for applicable calendar quarters even after the year in which the EUA Declaration ends, as long as these products have an FDA-approved application or license after the EUA Declaration is terminated

Wijnands JMA, Zhu F, Kingwell E et al (2018) Disease-modifying drugs for multiple sclerosis and infection risk: a cohort study

Hampe, CS Masked and overt autoantibodies specific to the DPD epitope of 65-kDa glutamate decarboxylase (GAD65-DPD) are associated with preserved beta-cell functional reserve in ketosis-prone diabetes J Clin Endocrinol Metab 99 6: E1040-4

Accutome products are available from Keeler, or selected distributor partners, all around the world