Immunosuppressive Drugs

50.5.1 - Immunosuppressive Drugs (Rev. 13108; Issued: 04-11-25; Effective: 01-01-25; Implementation: 05-12-25) Until January 1, 1995, immunosuppressive drugs were covered under Part B for a period of one year following discharge from a hospital for a Medicare covered organ transplant. The CMS interpreted the 1- year period after the date of the transplant procedure to mean 365 days from the day on which an inpatient is discharged from the hospital. Beneficiaries are eligible to receive additional Part B coverage within 18 months after the discharge date for drugs furnished in 1995; within 24 months for drugs furnished in 1996; within 30 months for drugs furnished in 1997; and within 36 months for drugs furnished after 1997. For immunosuppressive drugs furnished on or after December 21, 2000, this time limit for coverage is eliminated. The Consolidated Appropriations Act of 2021 amended section 1836(b) of the Social Security Act to add a new form of coverage that provides solely for coverage of immunosuppressive drugs beginning January 1, 2023, for eligible individuals whose entitlement to Medicare based on End-Stage Renal Disease (ESRD) ends the 36th month after the month in which the individuals receive a successful kidney transplant. This benefit is referred to as the Part B immunosuppressive drug benefit or “Part B-ID.” Refer to Pub. 100-01, Chapter 2, Section 40.9 for more information on Part B-ID. Covered drugs include those that meet one of the following conditions: 1. The drug has been approved for marketing by the FDA and — • The approved labeling includes an indication for preventing or treating the rejection of a transplanted organ or tissue; or • 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 the DME MAC (in accordance with 42 CFR Part 421 Subpart C), 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 derived only from a drug described in paragraph (1) or (2) of this section and is orally or enterally administered. Drugs are covered under this benefit irrespective of whether they can be self-administered. Antibiotics, hypertensives, and other drugs that are not directly related to rejection are not covered. CMS expects contractors to keep informed of drugs labeled for use in immunosuppressive therapy the FDA has approved for marketing.