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(2) The drug has been approved for marketing by FDA and determined by a Medicare Administrative Contractor (MAC) (in accordance with part 421, subpart C, of this chapter), in processing a Medicare claim, to be reasonable and necessary for the specific purpose of preventing or treating the rejection of a patient's transplanted organ or tissue, or for use in conjunction with immunosuppressive drugs for the purpose of preventing or treating the rejection of a patient's transplanted organ or tissue