Self-Administered Drug Exclusion List:

Medicare provides only limited benefits for outpatient prescription drugs. The program covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Each Medicare Administrative Contractor (MAC) as well as fiscal intermediary and carrier must make its own determinations for determining which drugs will be excluded from coverage. The detailed process for this determination is available in the CMS Internet-Only Manual (IOM) Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50.2. DEFINITIONS In making these determinations, Novitas Solutions used the following definitions: Self-administered —administered by the patient to him or herself. This does NOT include administration by spouses, nursing aides, allied health professionals, or physicians. Therefore, oral medications are considered self-administered drugs. However, payment for an oral drug is made as a rare exception when the drug is an oral anti-cancer drug or an oral antiemetic that is given with chemotherapy treatments (See CMS IOM Publication 100-02, Medicare Benefit Policy Manual , Chapter 15, Section 50.5.3 and 50.5.4). Usually self-administered —the term “usually” means more than 50% of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50% of Medicare beneficiaries, the drug is excluded from coverage and the contractor may not make any Medicare payment for it. In other words, this determination is made by evaluating beneficiaries as a collective whole rather than basing it on an individual drug or individual beneficiary. Acute Condition —any condition that the expected course of treatment is less than two weeks. Chronic Condition —any condition that requires treatment for more than two weeks. PROCESS OF DETERMINATION In making these determinations, Novitas Solutions uses the process prescribed by CMS. The process is summarized as follows. Statistical information is used to make the required decisions. However, when this data is not available the following factors are considered: route of administration, status of the condition, and frequency of drug administration. Route of Administration Drugs delivered intravenously are presumed to be NOT usually self-administered. Drugs injected intramuscularly are presumed to be NOT usually self-administered, although depth and nature of the drug may be considered. Drugs administered subcutaneously are considered to be usually self-administered. Status of the Condition Acute: any condition that the expected course of treatment is less than two weeks. Chronic: any condition that requires treatment for more than two weeks. Frequency of Administration Infrequent injection: e.g., drug given monthly or less than once per month. Frequent injections: e.g., drug given one or more times per week or more than once per month. Novitas Solutions arrived at a single determination for each drug listed in this article by reviewing each indication and route of administration for that indication. The relative contribution for each indication to the total use of that drug (i.e., weighted average) was obtained to determine the overall status of administration. For example, if a drug has three indications where the first indication makes up 40% of its use and is usually self-administered, the second and third indications make up 60% of its use and the drug is not usually self-administered for these indications, then the overall determination of that drug is that it is not usually self-administered. Conversely, if the first indication makes up 60% of its use and the drug is usually self-administered, and the second indication makes up 40% of its use and the drug is not usually self-administered, the overall determination made is that the drug is usually self-administered. After the route of administration is determined, the status of the condition and the frequency of administration are assessed. If the condition is acute or if the drug is given less frequently than one time per week, the drug is determined to be not usually self-administered. For certain injectable drugs, it is apparent that due to the nature of the condition(s) for which they are self-administered or the usual course of treatment for those conditions, the drugs are, or are NOT, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. For these drugs, the rationale for the determination is “apparent on its face value.” BENEFICIARY APPEALS A beneficiary may appeal the denial if a claim for a particular drug is denied because the drug is subject to the self-administered drug exclusion. Because it is a benefit category denial and not a denial based on medical necessity, an Advance Beneficiary Notice (ABN) is not required. A benefit category denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of limitation on liability (under Section 1879 of the Act). Therefore, physicians or providers may charge the beneficiary for an excluded drug. PROVIDER AND PHYSICIAN APPEALS A physician accepting assignment may appeal a denial under the provisions found in Chapter 29 of the CMS IOM Publication 100-04, Medicare Claims Processing Manual. For complete information on Medicare Regulations regarding Drugs and Biologicals, please refer to the CMS IOM Publication 100-02, Medicare Benefit Policy Manual , Chapter 15, Section 50. Coding Information Drugs and Biologicals furnished incident to a physician's service are subject to the Medicare self-administration drug exclusion. The evaluation of drugs for addition to the self-administered drug (SAD) list is an ongoing process. This list contains only those drugs and biologicals that are determined to be “usually self-administered by the patients” and therefore not eligible for Medicare coverage. 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 JA modifier for the intravenous infusion of the drug or billed with the JB modifier for subcutaneous injection form of administration. Absent to the contrary, the Contractor presumes that drugs delivered intravenously are not usually self-administered by the patient. The contractor will process claims with the JA modifier still applying the policy as stated in the Medicare Benefit Policy Manual , Chapter 15, Section 50.2 that not only must the drug be medically reasonable and necessary, but also that the route of administration is medically reasonable and necessary. 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. The drugs represented by HCPCS codes J0801 and J0802 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. Please refer to IOM 100-04, Chapter 17, Section 40 for complete information on the JA/JB modifiers.