Self-Administered Drug Exclusion List: (SAD List)

The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident to" a physician's service provided the drugs are not usually self-administered by the patients who take them. On May 15, 2002, the Centers for Medicare and Medicaid Services (CMS) issued Program Memorandum AB-02-072/Change Request 2200 which contains guidelines to be used by contractors to determine whether a drug or biological is usually self-administered and excluded from payment. For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage. Please note: some drugs may be listed more than once, using a different code, on the CPT/HCPCS coding table. The following guidelines are to be used for the process of determining whether a drug is usually self-administered: Evidentiary Criteria Only evidence of the following types will be considered: peer reviewed medical literature, standards of medical practice, evidence based practice guidelines, FDA approved labeling information and package inserts. Presumptions Because reliable statistical information on the extent of self-administration by the patient may not always be available, the following considerations will be used: Absent evidence to the contrary, drugs delivered intravenously should be presumed to be not usually self-administered by the patient. Absent evidence to the contrary, drugs delivered by intramuscular injection should be presumed to be not usually self-administered by the patient. Absent evidence to the contrary, drugs delivered by subcutaneous injection should be presumed to be usually self-administered by the patient. Absent evidence to the contrary, oral drugs, suppositories, topical medications and inhaled medications are considered to be usually self-administered by the patient. Additional consideration will be given to whether the condition being treated by the drug is acute or chronic and the frequency of administration. Basis for Non-Coverage Apparent on its Face For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered. The list of drugs identified below have been determined, following the above guidelines, to be usually self-administered by the patients who use them and are excluded from payment. Publication on this list begins a 45-day notice period whereby existing medical review and payment procedures will remain in effect. After the 45-day notice period ends, payment will be denied. The list will be reviewed periodically and updated as further determinations are made. Therefore, the absence of any particular drug on the exclusion list does not mean, at some later date, the drug might be deemed excluded based on the guidelines listed above. Presumption: Long-Term Non-Acute Administration In accordance with CMS instructions, if the condition being treated is for a short term acute basis (e.g. less than two weeks), the drug for this indication is considered "not usually self-administered." If the condition being treated is for a longer term (more than two weeks), the drug for this indication is considered "usually self-administered by the patient." Acceptable Evidentiary Criteria Available - Peer reviewed medical literature, - Standards of medical practice, - Evidence-based practice guidelines, - FDA approved label, and - Package inserts Route of Administration Modifier The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category will be marked with an asterisk (*) and must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection form of administration. Subcutaneously administered drugs listed on the Usually Self-Administered list will be denied as a benefit exclusion. Claims for drugs marked with an asterisk (*) billed without either a JA or JB modifier will also be denied. NOTE: The drugs represented by HCPCS codes J0801 and J0802 (marked with a double asterisk **) are administered by IM or SQ, therefore they require the JB modifier to be reported for SQ administration and they should not have any modifier reported for the IM administration. CPT/HCPCS Modifiers Group 1 Paragraph: Claim denials may occur when the appropriate modifier is not applied to a J code/medication, which has more than one route of administration. Group 1 Codes: JA Intravenous administration JB Subcutaneous administration