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ESRD is a medical condition in which a person's kidneys successively experience loss of functionality on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life

117-58, November 15, 2021) (IIJA), which amended section 1847A of the Act to require manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug (hereinafter, refundable drug), we are proposing a change in how we would identify certain drugs that are excluded from the definition of refundable drug for those which payment has been made under Part B for fewer than 18 months

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