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Impacts Related to Immunosuppressive Therapy In section III.A.4 of this final rule, we are finalizing modifications to regulations to include orally and enterally administered compounded formulations with active ingredients derived only from FDA-approved drugs where approved labeling includes an indication for preventing or treating the rejection of a transplanted organ or tissue, or for use in conjunction with immunosuppressive drugs to prevent or treat rejection of a transplanted organ or tissue, or that have been determined by a Medicare Administrative Contractor (MAC) to be reasonable and necessary for a specific purpose in immunosuppressive treatment included in the immunosuppressive drug benefit

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