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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

Zucchini S, Di Iorgi N, Pozzobon G, Pedicelli S, Parpagnoli M, Driul D, et al

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