Part D Off-Label Drug Coverage
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Part D Off-Label Drug Coverage

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August 29, 2013

Physicians may, and often do, prescribe medications to treat conditions and diseases not expressly approved by the Federal Drug Administration (FDA). These are entirely legal prescribing practices and are often the standard of care for important drug therapies for chronic and progressive medical conditions, such as cancer.

Part D plan coverage of drugs for off-label use is prohibited unless evidence is produced that the off-label use is recognized and sanctioned by one of several specified drug reference compilations, called drug compendia.

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