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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 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                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          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  | *This paper was prepared for discussion at the November               2006 meeting. It does not represent the official views of the               Council or of the U.S. government.*         Staff Working Paper       Organ Transplantation: Potential Policy Recommendations**By Sam Crowe, PhD, and Eric Cohen**
        Since February 2006, the Council has been engaged in an in-depth        inquiry into the ethical and policy dimensions of organ donation,        procurement, allocation, and transplantation. This inquiry has been        conducted through ten Council sessions, staff meetings with numerous        experts, extensive outreach to key organizations, and multiple staff        working papers. It is clear that the Council has a unique contribution        to make to current debates and will publish a report of its findings in        the spring of 2007.      

        As with its previous reports, the heart of the Council's contribution        will be in the realm of the ethical, with a series of core chapters on        the ethics of deceased donation, living donation, and organ allocation.        The report will subject various perspectives in the current debate to a        probing inquiry; it will explore the ethical obligations and ethical        dilemmas that shape current practices; and it will try to elucidate the        deeper human goods and attendant imperatives that shape organ donation,        procurement, allocation, and transplantation-from the meaning of the        human body to the nature of human death to the aspirations and limits        of medicine. The result should be an ethical analysis that every member        of the Council can "own."      

        The Council's work is situated amid widespread concern about the        current system of organ procurement and allocation, as the gap between        organ demand and organ supply continues to widen. Some experts and        organizations are interested in controversial-some would say        "radical"-reforms: from promoting donation after uncontrolled cardiac        death to enacting a policy of presumed consent to permitting and        promoting organ markets. Motivated by a desire to serve the public        good, each of these potential reforms deserves to be considered and        analyzed on its moral merits. The Council's report will surely offer        such analysis in full, giving every position its due and acknowledging        the disagreements that exist both in the country and among Council        members.      

        As the Council explores these potential reforms, it will also        describe-and, where appropriate, defend-the moral framework that        governs the current system of organ donation, procurement, allocation,        and transplantation. These governing principles include the following:      
-  that organ transplantation is a good that serves health and saves            lives, which should be facilitated by public policy; 
-  that being a donor is a personal decision requiring voluntary consent,            a consent that cannot be presumed; 
-  that families, especially the families of the newly deceased, should            have their needs and wishes respected, especially during the final            moments of a loved one's life and in the first moments of mourning; 
-  that physicians and medical institutions have an obligation to ensure            that organ donation is safe, free from coercion, and, in the case of            deceased donors, only begins once the donor is rightfully declared            dead; 
-  that everyone on the organ waiting list should be treated fairly,            allocating organs according to principles of equity and utility that            apply universally to everyone; 
-  and that organ donors should be true donors, providing organs not for            pay or profit but as gifts of the body to those whose bodies are            failing. 

        This staff working paper explores a series of focused policy        recommendations that work within the general ethical framework of the        current system. These recommendations envision reforms that serve one        or more of the moral goals of the current system, without violating any        of the principles integral to its overarching moral framework. These        recommendations are offered as potential recommendations; they are        intended to spur and direct Council discussion and to assess where the        Council might pledge its support. For those recommendations that do        seem to have broad support, the staff will develop them further and in        greater detail.      

        There are nine potential recommendations, which are organized into four        thematic categories:      

        The first category includes four policies that aim at protecting the        health and well-being of the living donor and his/her family and at        easing the economic burden of living donation, especially for those        with limited resources. This includes providing all donors with a        legally protected unpaid leave of absence from work; providing donors        with tax credits to cover the direct costs associated with donation;        providing donors with life and disability insurance to protect donors        who die or become debilitated due to complications from donation; and        providing donors with supplementary health insurance to cover the        incremental additional health expenses connected to donation.      

        The second category includes one policy recommendation that aims at        improving the care of transplant recipients by making Medicare        immunosuppressive drug coverage for organ recipients lifelong.�      

        The third category includes two policies that would better serve the        aims of equity and utility in organ allocation: first, by taking        measures to mitigate geographical inequities in organ allocation, and        second, by reforming the criteria that govern kidney allocation.�      

        The fourth category includes two policies that aim at expanding the        supply of available organs within the moral framework of the current        system. This includes the promotion of ethically responsible criteria        for planned donation after cardiac death; and the promotion of paired        and list donation, understood as forms of creative gifting.�      

**Category #1: Ensuring the Well-Being of Living Donors**

*Unpaid Leave of Absence for Organ Donation*

        On April 28, 2005, some members of the House of Representatives        introduced a bill called the "Living Organ Donor Job Security Act of        2005." The bill proposes to amend the Family and Medical Leave Act of        1993 to include a provision for organ donation.�      

        The 1993 Act declared that employees who have worked for at least        twelve months for a specific employer and who have worked for at least        1250 hours during that twelve month period may take an unpaid leave of        absence for twelve work weeks for a few specific conditions. These        conditions include the birth and care of a baby, the adoption and care        of a child, the care of a sick family member, or the recovery of the        employee from serious illness.�      

        Only certain employers are covered by the 1993 Act. All public service        employers, all primary and secondary schools, and all employers who        have fifty or more employees for at least twenty of the calendar work        weeks must allow their employees to take this form of leave if needed.        Those private employers who regularly have less than fifty employees        are not bound by the law to permit this form of leave of absence.      

        The Living Organ Donor Job Security Act would amend the Family and        Medical Leave Act by including organ donation as one of the eligible        reasons for taking a legally protected leave of absence. The bill lists        six specific donation-related activities that the leave would cover:        tests to determine if the person is medically suitable to be a donor,        evaluations to determine if the person has the requisite mental health        to be a donor, pre-transplantation medical services, post-operation        services, travel during the total process, and recuperation time. The        bill does not specify the length of the leave of absence that would be        granted, but presumably the leave would be the same as the other        conditions already permitted.      

        It is worth noting that all federal government employees, government        employees of some states (Delaware, Maryland, Missouri, Ohio, Utah, and        Virginia), and government employees of the District of Columbia        currently may take thirty days of paid leave to be organ donors. The        Living Organ Donor Job Security Act would supplement this leave for        these federal and state employees by two months. But the bill neither        recommends that public sector donors should be paid during the extra        two months, nor proposes that private sector employees should be paid        at all.      

        The Council could recommend passage of this or a similar bill. Such a        law would build on the well-established practice of allowing employees        to take leave from work to perform life-giving or care-giving        activities, without requiring that employers pay employees who are not        working. Such a law would ensure that fear of job loss is not the        reason that a willing donor does not donate, without unduly burdening        private employers with mandates they may not be able to fulfill. It        thus balances, in a subtle way, the competing needs of employees and        employers.      

        In the context of organ donation, the law could be made more or less        specific-for example, by setting different periods of leave for        different types of organ donation, or by making clear that the period        of permissible leave can be broken up to account for pre-donation and        post-donation activities. But the overriding moral principle is clear:        living donors should not fear for their jobs in making the decision to        donate, and in this limited way, the public sector can protect living        donors from this concern.      

*2. Tax Credits to Compensate the Direct Costs of Donating*

        Section 274e of Title 42 of the U.S. Code states the following: "the        term 'valuable consideration' does not include the reasonable payments        associated with.the expenses of travel, housing, and lost wages        incurred by the donor of a human organ in connection with the donation        of the organ." This law in effect permits reimbursement for the        financial costs incurred during the donation process, but it does not        support any particular means of payment. A few states (Arkansas,        Georgia, Iowa, Minnesota, New Mexico, North Dakota, Oklahoma, Utah, and        Wisconsin) have created reimbursement programs, but as of now there is        no federal policy to compensate donors for their expenses.      

        In the spring of 2005, a few members of the House of Representatives        presented a bill entitled the "Living Organ Donor Tax Credit Act of        2005." The bill proposes to amend the Internal Revenue Code of 1986 to        include a nonrefundable personal tax credit for the financial costs of        living donation. The credit would cover un-reimbursed costs related to        the process of donation, offering a tax credit up to a maximum amount        of $5,000. Eligible expenses include the costs of transportation,        lodging, and any wages lost during the transplantation process. The        credit would only be given if an organ is actually removed.      

        The moral aim of such a policy is to reduce the financial impediments        to being an organ donor. For most people, living without pay and paying        for the travel and lodging expenses connected to donation is a serious        burden, making donation difficult and in some cases impossible. A        policy of reimbursement for expenses, using tax credits, would help        generous donors to be generous by easing the direct financial costs of        their act of organ gifting. Such reimbursement is not an incentive to        donate or a form of payment for donating, but a way to ensure that        donation does not lead to economic problems or even temporary        impoverishment for donors.      

        A policy of tax credits has certain specific advantages: it employs an        existing tax mechanism as the means of reimbursement; it works within        existing law on organ transplantation, requiring no alteration of the        valuable consideration statute; it focuses on specific expenses rather        than offering a general reimbursement; and it both protects organ        donors and promotes organ donation in a way that is entirely consistent        with the ethical framework that governs the current system. Taken        together, such a policy would provide assistance to those who "give the        gift of life" by giving of themselves, quite literally, to help another        in need. And, inasmuch as it expands the number of donors and thus        reduces the number of patients on dialysis, the economic positive might        outweigh the economic cost of the program.      

        The Council could recommend passage of a version of the tax credit law,        either in the form already proposed in Congress or with some        modification. As for potential modifications, it could recommend that        the size of the tax credit be either expanded or reduced. It could        recommend that eligibility for the tax credit depend on the personal or        family income of the donor, thus tailoring the program to assist donors        most in need. Or it could recommend that the size of the tax credit        depend on personal or family income (i.e., a larger credit for less        wealthy donors, a smaller credit for more wealthy donors). Whatever the        specifics, however, the overriding principle would be that the public        sector has a compelling moral interest in helping generous people be        generous; just as charitable donations are tax deductible, we could        make the financial costs of being a living organ donor reimbursable,        especially for those who stand to bear the greatest economic burden        from being a donor.      

*3. Limited Life and Disability Insurance for Living Donors*

        Like all surgery, living donation carries certain risks. Kidney        donation has a morbidity rate of 1-10% and a mortality rate of 0.03%;        partial liver donation has a 10% morbidity rate and 0.2% mortality        rate. While the risk is relatively low, the possibility that the donor        may become disabled or die is also real. For donors with dependents,        the fear of leaving their families in economic turmoil could become a        reason not to donate, and in those cases of mortality or debilitating        morbidity, poor families most of all could be left in financial ruin.      

        To ameliorate some of the economic risks associated with living        donation, the Council might recommend publicly-subsidized life and        disability insurance targeted especially to those with limited means.        The available insurance would only cover mortality and morbidity that        result directly from the act of donation, both in surgery and due to        post-operative complications. Such a policy would not be an inducement        to donate, but rather a form of protection for donors and their        families, allowing them better to cope in the event that the worst        imaginable scenarios become tragic realities.      

        In practical terms, the policy could be structured in various ways. It        might be similar to the insurance policies offered to members of the        armed forces, with donors paying a small fee to opt into the system and        the federal government paying out the policies in the case of        disability or death. Such policies could be available either to all        living donors or to all donors with annual incomes and net worth        beneath a certain eligibility threshold. There could be a single-rate        fee or the fee could be mean-tested to reduce or eliminate the cost for        the poorest donors. Eligibility could be tied to routine follow-up        care, thus requiring that donors care for themselves if the public        sector is going to help care for them and their families.        Alternatively, the law might offer tax breaks or other incentives to        entice private life and disability insurance companies to offer        insurance to living organ donors at a reduced price.�      

        Regardless of its ultimate form, this policy recommendation would        probably require that the existing statute governing organ        transplantation be amended to clarify that the limited form of life and        disability insurance proposed here is not a form of valuable        consideration. Such a policy recommendation, however, would not shift        the moral framework that informs the existing law: namely, that organ        donation should be an act of generosity, not a form of commerce.        Rather, such a policy would remove a potential barrier to donation-fear        of impoverishing one's family-and it would ensure that donor families        are not left in economic ruin in the tragic event that their family        provider can no longer provide for them.      

*4. Supplementary Health Insurance for Living Donors*

        Even in the vast majority of cases, when organ donation proceeds        without major complications, there are often additional healthcare        expenses and minor complications incurred by donors, including expenses        that extend beyond the term of coverage by the organ recipient's        insurance policy. And, yet again, it is poorer donors, especially those        with high co-payment or high-deductible insurance policies, that stand        to bear the greatest additional burden.      

        To address this problem, the Council might recommend offering        publicly-subsidized supplementary health insurance for living donors to        cover the incremental, out-of-pocket costs connected to the act of        donation. This recommendation would be offered as a form of care for        donors intrinsically connected to the act of donation, and it would be        a way to ensure that donors take care of themselves-most notably, that        donors go for all of their necessary follow-up visits, rather than        avoiding extra doctor visits to avoid extra costs. Such a program could        also be tied to expanded follow-up studies of living donors. Like the        reimbursement program recommended above, it could take the form of tax        credits for extra medical costs incurred because of donation. It could        be available to all donors or targeted to donors below a certain        income-level.      

        A more expansive and more costly recommendation would be to make all        living donors eligible for public health insurance, perhaps through the        Medicare system. The trouble with offering public health insurance to        all living donors, however, is that it risks becoming an inducement to        donation rather than a form of proper care for donors. Some        individuals, lacking quality health insurance or worried about the high        cost of health insurance, might donate in order to become eligible for        publicly-provided healthcare. By contrast, a system of supplementary        health coverage, focused only on covering those costs and complications        related to the act of donation, would ensure that the existing system        of organ gifting is not undermined.      

        Such a targeted policy of supplemental insurance could be combined with        greater legal protections to guarantee that living donors are never        adversely affected in the private health-insurance market because they        were donors-such as prohibiting insurance companies from treating        donation itself or complications due to donation as cost-increasing        pre-existing conditions.      

        For donors without health insurance, the policy could require        transplant centers to investigate whether the potential donor is        eligible for Medicaid, and if so, to facilitate enrollment. For those        donors without insurance who are not eligible for Medicaid, the program        could cover the entire cost of care related to the act of donation,        either by reimbursing the donor or by paying the transplant center        directly.      

        Whatever specific form a policy of supplemental health coverage        ultimately takes, the principle guiding such a recommendation would be        clear: there is a moral obligation to ensure that living donors are        cared for. To permit and even encourage organ donation while leaving        donors at undue risk because they lack healthcare coverage is morally        irresponsible. As with life and disability insurance, such a policy        would probably require an amendment to existing law. This amendment        would clarify that providing limited supplemental health coverage is a        form of care for living donors inextricable from the act of donation,        not a form of valuable consideration or an inducement to donate. And,        once again, this shift in the law does not involve an alteration in the        moral aims that govern the law: namely, ensuring that organ donation is        always an act of generosity, motivated by beneficence rather than the        pursuit of profit.      

**Category #2: Improving Care for Transplant Recipients**

*5.� Comprehensive Immunosuppressive Drug Coverage*

        To combat organ graft rejection, transplant recipients must take        immunosuppressive drugs for the rest of their lives. These drugs are        fairly expensive, costing on average $1,000 per month. Private health        insurance can defray much of the cost, but for those who do not have        private insurance, for those with only minimal coverage, and for those        with limited financial means, the out-of-pocket cost for these drugs        can be prohibitive. Many of those who would not be able to afford the        drugs on their own qualify for Medicare drug benefits-specifically,        those who are 65 and over, those who are legally considered disabled,        and those who have end-stage renal disease. The problem is that for the        third class of patients-those whose Medicare eligibility is tied to        their end-stage renal disease-Medicare only covers the cost of the        immunosuppressive drugs for three years.      

        In addition to the time limit on drug coverage, there are two other        significant limitations that affect Medicare eligibility for drug        coverage for transplant recipients. First, if a transplant recipient is        not eligible for Medicare at the time of the transplant, then the        recipient cannot receive immunosuppressive drug coverage through        Medicare even if the patient becomes of Medicare age or disabled.        Second, if the patient receives a transplant in a hospital that is not        Medicare approved, then the recipient cannot later receive        immunosuppressive drug coverage even if the patient would otherwise        qualify for it.��      

        Currently, the Senate has a bill at the committee level called the        "Comprehensive Immunosuppressive Drug Coverage for Transplant Patients        Act of 2005." The bill would change the law by striking the three-year        time limit on Medicare drug coverage for transplant recipients who were        previously part of Medicare's end-stage renal disease program. It would        also provide immunosuppressive drug coverage for all individuals        covered by Medicare, regardless of whether or not they were eligible        for Medicare benefits when they had their transplant and regardless of        whether or not the transplant took place in a hospital approved by        Medicare.      

        The Council could pledge its support for such a policy, which makes        both economic and moral sense. First, lifetime immunosuppressive drug        coverage is less expensive than the alternative in most cases. If a        recipient's new kidney fails (this situation only applies to kidney        failure, but most of the organs transplanted are kidneys), then        Medicare will cover the cost of future dialysis and another kidney        transplant. Dialysis costs on average $4,000 per month, while a        transplant operation costs roughly $100,000. Compared to these costs,        the $1,000 per month for immunosuppressive drugs is minuscule.      

        Second, premature transplant failure, when caused because the recipient        stops taking immunosuppressive drugs, is not only expensive but tragic        and wasteful. To continue with the kidney example, the normal lifespan        of a transplanted kidney is on average 8 to 12 years. When recipients        who cannot afford the immunosuppressive drugs begin losing their        transplanted kidneys at 4 to 5 years, these recipients lose on average        3 to 8 years of a good functioning kidney, and often are added once        again to the waiting list. Given Medicare's large role in caring for        those with end-stage renal disease through its dialysis program,        providing lifelong immunosuppressive drug coverage seems like a wise        investment: ensuring that the sick take care of themselves, and        preventing the avoidable return to dialysis for patients who stop        taking their medications because they cost too much.

**Category #3: Improving Organ Allocation**

*6.� Mitigating the Role of Geography*

        Utility and equity are the central moral ideals that govern the        existing system of allocating organs to those on the public waiting        list. The practical application of these moral ideals is a complicated,        ongoing process, rooted in both certain historical realities about how        organ transplantation took shape in the United States and in certain        clinical realities about the viability and compatibility of human        organs.      

        Both procuring and allocating organs originated as local practices,        shaped by and directed to the needs of local and later regional        communities.�In 1984, the passage of the National Organ Transplantation        Act by Congress signaled a new phase in the evolution of allocation        policy: organ transplantation was embraced as a medical innovation of        national-rather than local or regional-significance, as was the need        for a more ordered, principled approach to securing and distributing        the precious resource of human organs.�Subsequent legislative and        regulatory initiatives, by Congress and the Department of Health and        Human Services, have served to articulate and to buttress three        ethically relevant norms: first, in organ allocation, the operative        sense of community should be the national (rather than local or        regional) community; second, organs should be allocated in ways that        achieve their best, most efficient usage; and third, beyond effective        usage, the most important criterion in allocating human organs should        be patient need.      

        In recent years, there has been laudable progress in the effort to        bring the system of allocation into conformity with these norms.�For        example, reforms in the allocation algorithms for livers and lungs have        tilted the balance of criteria toward urgency of patient need and, as a        result, there are now fewer deaths on the waiting list for these organs        and geographic disparities have been lessened.�Nonetheless, so-called        "accidents of geography" remain; where a person is registered as a        transplant candidate continues to be a potent factor in determining        whether one ultimately receives an organ or not.�To the extent that        organ viability is critical to the efficient, effective use of these        scarce resources, geography will remain a constraining factor in the        allocation of human organs, especially hearts.�Yet the geographical        inequities that persist in current practice are not dictated entirely        by the demands of utility. In some cases, the most worthy recipient,        judged by criteria of physiology, age, medical urgency, or waiting        time, is not getting an available and viable organ, or is waiting much        longer for such an organ, simply because they live in the wrong place.      

        Clearly, there are significant challenges and obstacles that mark the        path toward greater geographical equity in the system. Moreover, the        original and now traditional practice of procuring and allocating        organs within the same local community is deeply entrenched, in part,        because it has served legitimate community needs-and served them        well.�For sound ethical reasons, however, the nation has embraced        geographical equity as the most defensible basis for allocating human        organs.�In deference to this ideal, the Council could urge UNOS and the        Department of Health and Human Services to continue to explore and        institute reforms that would ensure that allocation serves the needs of        patients, unfettered by accidents of geography.      

*7.� Greater Equity and Utility in Kidney Allocation*

        At present, the factor weighed most heavily in kidney allocation,        beyond physiological compatibility between donors and recipients, is        waiting time. While this criterion serves equity in an obvious sense,        giving waiting time such a high importance in allocation risks        undermining utility and equity in other crucial ways. To begin with, it        means that the value of receiving an organ is diminished by waiting for        years on dialysis in order to receive it; the result is that we are        getting fewer quality years out of the organs we transplant. We are        also transplanting organs to a comparatively older rather than younger        set of patients with renal failure. The Council could recommend        reforming the kidney allocation system to give greater relative weight        to other factors. Such factors might include:      

*Age of Recipient*: Already, we give priority in kidney allocation        to pediatric patients. The Council could recommend expanding this        principle to benefit comparatively young, non-pediatric patients-for        example, by assigning points for age in a sliding scale, such that as        age increases, the points in the algorithm assigned for age decrease.      

*Age Relationship of Donor and Recipient*: Under the current        allocation system, organs from 20 year old deceased donors are        sometimes transplanted into 60 year old recipients. The Council could        recommend developing a policy requiring that donors and recipients be        of a certain proximate age: for example, a 50 year old on the waiting        list could be eligible for organs only from donors within a decade of        his or her age (i.e., 40 to 60 year olds).      

*Long-Term Benefit*: The Council could recommend giving greater        relative weight to donors who stand to benefit the longest from        receiving a kidney transplant.      

*Net Benefit*: The Council could recommend giving greater relative        weight to donors who would likely receive the greatest net benefit from        a kidney transplant compared to continuing with dialysis. Such a net        benefit calculation could also take into account the comparative        quality of life on dialysis versus life after transplantation.      

        Each of these proposed reforms of course invites its own criticisms and        problems-including the problem of shifting from the current system to a        reformed system. Any system of allocating a scarce resource stands to        benefit some and thus disadvantage others. But there are sound reasons        to conclude that the current system is not the only way, or the best        way, to serve the goals of utility or equity in kidney allocation, and        that it will serve these goals even less well as the size of the        waiting list continues to grow. In particular, by giving some relative        preference to the young, a reformed allocation system would attempt to        ameliorate some of the inequities of nature (such as getting end-stage        renal disease in one's twenties) in addition to maximizing the benefits        received from transplanted organs; it would not discriminate against        the old, but recognize that in allocating a scarce resource, we need to        do so based on some moral understanding of whose claims are the        weightiest.

**Category #4: Encouraging Ethically Responsible Ways to Increase the        Organ Supply**

*8. Encourage Ethically Responsible Donation after Cardiac Death (DCD)*

        In certain, well-defined clinical circumstances, doctors and family        members decide that continued life-sustaining treatment no longer        benefits the life the patient still has. Some of these patients are        potential organ donors, and the number of cases of planned donation        after cardiac death (commonly called "controlled" DCD) has been slowly        increasing in recent years: in 1994 there were only 11 donations after        planned cardiac death, whereas in 2004 there were 366. Those 366        deceased donations produced 689 kidneys, 233 livers, 47 pancreata, and        10 lungs. This expansion could become much larger if the large number        of centers that do not have protocols in place for planned DCD are        encouraged to develop them. The Council could recommend a morally        responsible expansion of this practice-both to ensure that wherever it        is done, it is done responsibly, and to encourage a morally sound way        to increase the organ supply.      

        Donation after planned DCD should only be practiced within an explicit        hospital policy framework governed by clear moral criteria. A morally        sound hospital policy would include the following: (1) The decision to        withdraw interventions must be made independently of the decision to        donate. (2) Donors must receive the same end-of-life palliative care as        non-donors. (3) The hospital should provide the potential donor's        family with the option of being present when life support is withdrawn        and, in general, take every measure to permit family and friends to say        goodbye in a dignified way. In addition, families should not incur any        additional costs related to donation. (4) Procurement teams must wait        the recommended amount of time (2-5 minutes) after the permanent        cessation of heart function before beginning the removal of the organs.        (5) The medical staff overseeing withdrawal of interventions must not        hasten the patient's death, even if the organs might become        un-transplantable. (6) If patients do not die quickly enough to become        donors, a procedure should be in place to return these patients to the        intensive care unit to die in a peaceful and respectful way. In        general, the desire to expand the practice of DCD procurement should        not encourage hospitals to proceed without transparent policies in        place that ensure consistent and ethical practice.      

        Several moral arguments can be marshaled in support of encouraging        planned DCD.� First, it would increase the organ supply in a way that        is entirely consistent with current ethical standards: the donors        and/or the families freely consent to donation; the donors are dead        before becoming donors; and every possible effort can be taken to        respect the needs and wishes of the donor's family in the last moment        of life and first moments of mourning. Second, it would extend the        opportunity for individuals and families to donate in situations in        which they are currently unable to do so. And third, establishing clear        protocols for planned DCD would help to ensure that a bright line is        maintained between those patients who are already dead by neurological        criteria and those who are still alive though severely neurologically        compromised. If DCD preparedness provides another responsible means for        facilitating donation after death, then the temptation to use nearly        dead patients as a source of organs should be diminished.      

       The Organ Donation        Breakthrough Collaborative is actively working to help develop and        spread ethically sound protocols for planned DCD. The primary thrust of        the Collaborative's efforts aim at educating and training hospitals,        organ procurement organizations, and transplant center staff. The        Collaborative is also supporting research that aims at achieving higher        transplantation success rates with organs procured after cardiac death        by spreading information about better surgical techniques, better organ        preservation, and better matching with potential recipients.

        The efforts of the Collaborative are in sync with actions being taken        by UNOS and other groups to provide incentives and requirements to        hospitals to expand the practice of DCD. UNOS adopted a resolution in        August 2006 to include in its bylaws a requirement that all        participating organizations have a DCD protocol in place by January 1,        2007. The organizations that would be subject to this requirement        include all organ procurement organizations and all transplant        hospitals, where procurements also take place. The requirement would        not force all potential donor hospitals to have protocols because the        OPTN has no jurisdiction over these centers. A requirement to develop        DCD protocols in every hospital is currently being considered by the        hospital accreditation body, the Joint Commission on Accreditation of        Healthcare Organizations (JCAHO). A Council endorsement of ethically        responsible planned DCD could mean lending its weight to some of these        efforts.      

*9.� Encourage Paired Donation and List Donation*

        Paired donation and list donation are creative forms of organ gifting,        allowing living donors who are not biologically compatible with their        intended recipients to work together with one another, or in        conjunction with the public waiting list, to make donation possible in        cases when otherwise it would not be. A paired donation generally        involves two living donors and two intended recipients: Donor A gives        to Intended Recipient B, and Donor B gives to Intended Recipient A.        Paired donations can also occur among multiple pairs of donors and        recipients. A list donation occurs when Donor A desires to give a        kidney to Intended Recipient A who is not biologically compatible.        Instead, Donor A gives a kidney to someone on the kidney waiting list,        and in exchange Recipient A receives a compatible kidney from the list        more quickly than if Donor A did not donate to the list.�      

        Paired donation and list donation can be combined and used together in        what is called a "chain exchange." Chain exchanges, in their simplest        form, entail two pairs (A and B) that do not qualify for paired        donation, meaning that both donors do not match the recipients of the        opposite pair. Instead, only the donor of pair A matches the recipient        of pair B. In a chain exchange, the donor of pair A gives a kidney to        the intended recipient of pair B, and the donor of pair B in turn gives        a kidney to the general kidney list. The intended recipient of pair A        then moves up the waiting list for kidneys.      

        Paired donation and list donation are not new ideas. Transplant        surgeons in some centers have been doing them for the past few years.        The first documented list donation occurred in 2001 at the New England        Program for Kidney Exchange. There have been an estimated 55 list        donations carried out in the United States. The Johns Hopkins'        Comprehensive Transplant Center performed the first simple paired        donation in the United States in 2001 and the first triple kidney        donation in August 2003. In total, there have been an estimated 125        transplants using paired donations in the United States.      

        In February 2006, a few Senators introduced a bill called the "Living        Kidney Organ Donation Clarification Act." The bill would clarify under        law that paired donation and list donation do not involve the giving of        kidneys for valuable consideration. The bill is currently with the        Committee on Health, Education, Labor, and Pensions.�      

        Beyond clarifying the legality of these practices, there are two main        ways that a policy promoting paired and list donation could be        implemented. First, Congress could grant the OPTN extensive control        over paired and list donation. The OPTN would then most likely create a        national paired donation registry and clear rules to ensure that list        donations do not unfairly disadvantage those who are already at the top        of the waiting list, especially those with rare blood types. This        approach would presumably bring many potential donors to the registry,        and would unify the registry policy and living organ donation policy        more generally.�������      

        The second approach would be to provide federal assistance directly to        transplant hospitals to help them to develop or to expand paired and        list donation programs without OPTN interference. This option would        include offering grants for paired donation registries to cover        registry costs, such as the salary for transplant coordinators, public        education expenditures, and ongoing research. This option would help        private organizations to explore further the different ways of running        patient registries without the bureaucratic oversight that would be        part of the OPTN system.      

        The Council could both recommend passage of the Living Kidney Organ        Donation Clarification Act and encourage the creation of expanded and        ethically responsible national/local protocols for paired donation and        list donation. Such a recommendation would help facilitate this        creative form of gifting, allowing generous potential donors to become        actual donors. Through these measures, the bonds of community could be        both widened and deepened, binding individuals to one another through        mutual acts of generosity.�                                                               |