El propósito de este capítulo es establecer parámetros para el pago o reembolso de los costos relacionados con los medicamentos que, a pesar de tener la aprobación de la Administración de Drogas y Alimentos de Estados Unidos (FDA, por sus siglas en inglés), son utilizados para indicaciones diferentes a las que aparecen en la etiqueta (uso que en lo sucesivo se denominará “uso no indicado en la etiqueta”). Denegar el pago o reembolso de los medicamentos por motivo de que el mismo será utilizado para un uso no indicado en la etiqueta podría interrumpir o impedir el acceso al tratamiento necesario y adecuado para las personas cubiertas o asegurados.
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