§ 410.30 Prescription drugs used in immunosuppressive therapy.

(a) Scope. Payment may be made for prescription drugs used in immunosuppressive therapy that meet one of the following conditions: (1) The drug has been approved for marketing by the FDA and— (i) The approved labeling includes an indication for preventing or treating the rejection of a transplanted organ or tissue; or (ii) The approved labeling includes the indication for use in conjunction with immunosuppressive drugs to prevent or treat rejection of a transplanted organ or tissue. (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. (In making these determinations, the MACs may consider factors such as authoritative drug compendia, current medical literature, recognized standards of medical practice, and professional medical publications.) (3) The drug is a compounded formulation with active ingredients derived only from a drug described in paragraph (a)(1) or (2) of this section and is orally or enterally administered. (b) Eligibility. For drugs furnished on or after December 21, 2000, coverage is available only for prescription drugs used in immunosuppressive therapy, furnished to an individual who received an organ or tissue transplant for which Medicare payment is made, provided the individual is eligible to receive Medicare Part B benefits, including, beginning January 1, 2023, an individual who meets the requirements specified in § 407.55 of this subchapter. (c) Coverage. Drugs are covered under this provision irrespective of whether they can be self-administered.