Drugs and Biologicals

50 - Drugs and Biologicals (Rev. 1, 10-01-03) B3-2049, A3-3112.4.B, HO-230.4.B The Medicare program provides limited benefits for outpatient drugs. The program covers drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. Generally, drugs and biologicals are covered only if all of the following requirements are met: • They meet the definition of drugs or biologicals (see §50.1); • They are of the type that are not usually self-administered. (see §50.2); • They meet all the general requirements for coverage of items as incident to a physician’s services (see §§50.1 and 50.3); • They are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered according to accepted standards of medical practice (see §50.4); • They are not excluded as noncovered immunizations (see §50.4.4.2); and • They have not been determined by the FDA to be less than effective. (See §§50.4.4). Medicare Part B does generally not cover drugs that can be self-administered, such as those in pill form, or are used for self-injection. However, the statute provides for the coverage of some self-administered drugs. Examples of self-administered drugs that are covered include blood-clotting factors, drugs used in immunosuppressive therapy, erythropoietin for dialysis patients, osteoporosis drugs for certain homebound patients, and certain oral cancer drugs. (See §110.3 for coverage of drugs, which are necessary to the effective use of Durable Medical Equipment (DME) or prosthetic devices.)