Self-Administered Drug Exclusion 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 that the drugs are not “usually self-administered” by the patient. Section 112 of the Benefits, Improvements & Protection Act of 2000 (BIPA), amended §§1861(s)(2)(A) and 1861(s)(2)(B) of the Social Security Act (SSA) to redefine this exclusion. The prior statutory language referred to those drugs "which cannot be self-administered ”. Implementation of the BIPA provision requires interpretation of the phrase "not usually self-administered” by the patient. CMS has defined "not usually self-administered" by the patient, according to how the Medicare population as a whole uses the drug, not how an individual patient or physician may choose to use a particular drug. This is defined in the CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2, Determining Self-Administration of Drug or Biological. For purpose of this exclusion, 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 this A/B MAC may not make any Medicare payment for it. The term 'administered' refers only to the physical process by which the drug enters the patient's body. Injectable drugs, including intravenously administered drugs, are typically eligible for inclusion under the 'incident to' benefit. With limited exceptions, other routes of administration including, but not limited to, oral drugs, suppositories, topical medications are considered to be usually self-administered by the patient. The term 'by the patient' means Medicare beneficiaries as a collective whole. The determination is based on whether the drug is self-administered by the patient the majority of the time. This determination is made on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis. This A/B MAC is committed to assuring appropriate coverage for those drugs that meet Medicare statute requirements for drugs, "not usually self-administered by the patient". In the absence of objective data specific to the Medicare beneficiary population who are capable of self-administration of an injectable drug, this A/B MAC will consider the following factors listed below, weighted on a per indication basis, to estimate, whether an injectable drug in the outpatient setting is "usually or not usually self-administered": 1. Route : Intravenous (IV) route and Intramuscular (IM) route of administration will be presumed to meet "not usually self-administered" requirements and therefore meets Medicare benefit category requirements. Palmetto GBA may consider the depth and nature of the particular injection in applying this presumption. Subcutaneous (SQ) route of administration will not be presumed to meet the "not usually self-administered by the patient." 2. Acuity of condition being treated : In accordance with CMS instructions, if the condition being treated is for a short-term acute basis (e.g., less than 2 weeks), the drug for this indication is considered "not usually self-administered". If the condition being treated is for a longer term (e.g., more than 2 weeks), the drug for this indication is considered "usually self-administered by the patient". 3. Setting of condition being treated : To the extent an injectable drug for a particular indication is given (e.g., only in an emergency department setting, pre-operative outpatient setting, or in the context of chemotherapy administration), the drug for that indication would be presumed to be for an acute situation and therefore "not usually self-administered". 4. Frequency of administration : In accordance with CMS instructions, if a drug is administered once per month, it is less likely to be self-administered by the patient. If a drug is administered once or more per week, it is likely that the drug is administered by the patient. Process For Determining Benefit Category To determine if a drug meets the definition of “usually self-administered” on a Medicare population basis, as required by CMS instructions, this A/B MAC will use the following process: Self-Administered Drug Process Flow The process steps to determine whether a drug is self-administered are as follows: Determine if the drug is produced in parenteral form. Determine the route of administration. If the drug is only administered IV, the drug is a covered benefit. Determine if the route of administration is IM or SQ, and if the drug is administered in the outpatient setting, list the clinical indications and determine the percent of utilization by clinical indication. Review claims data and check a variety of sources/factors to arrive at the preliminary recommendation: Acute/chronic setting Clinical indication FDA/drug package inserts Provider specialty Estimate the percent self-administered (greater than or less than 50%) by indication. Assess all information to determine whether the drug is covered under the benefit category and notify providers via the Palmetto GBA website. If a drug meets the definition of "usually self-administered", this A/B MAC will determine that the drug does not meet a Medicare benefit category. In this instance when the drug is administered "incident-to" the physician service, the provider may bill the beneficiary for the drug without an Advance Beneficiary Notice. Route of Administration Modifier The use of the JA and JB modifiers is required for drugs which have 1 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 IV infusion of the drug or billed with the JB modifier for the SQ injection form of administration. Claims billed with the JA modifier are not part of the SAD exclusion. The Contractor will process claims with the JA modifier applying the policy that not only the drug is 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. 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 Consideration of Objective Evidence In accordance with CMS instructions, this A/B MAC will consider objective evidence, when available, to determine utilization of a particular drug. Evidence This A/B MAC welcomes any data and evidence that describes utilization of injectable drugs in the outpatient setting, specific to the Medicare beneficiary population as outlined above. This A/B MAC is only required to consider the following types of evidence: Peer reviewed medical literature, Standards of medical practice, Evidence-based practice guidelines, FDA approved label, and package inserts. This A/B MAC may also consider other evidence submitted by interested individuals or groups subject to their judgment. This A/B MAC will consider all of the information it receives in order to make a balanced and considered determination of benefit category meeting “not usually self-administered” injectable drugs. The information will be weighted according to the strength of the evidence. General Information These drugs have been deemed by this A/B MAC to be excluded from payment "incident-to" a physician's service because they are usually self-administered by the patients who take them. The publication of this list begins a 45-day notice period. After the 45-day notice, this A/B MAC will deny payment for drugs subject to this notice. This list will be reviewed on a rolling basis and will be periodically updated as needed. Therefore, the absence of any particular drug on the exclusion list should not be taken to mean that at some later date the drug might be deemed excluded through application of the criteria referenced above. 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 (chronic vs acute), they are, or are not, usually self-administered. For example, a course of treatment consisting of scheduled injections lasting less than 2 weeks, regardless of frequency or route of administration, is considered by CMS as acute, and it would be unlikely that a patient would self-administer the drug in those circumstances [CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §50.2] Basis for Non-Coverage A. Apparent due to the nature of the condition(s) for which they are administered, B. Presumption: Long-Term Non-Acute Administration, C. Acceptable Evidentiary Criteria Available Coding of Unclassified Drugs Many of the drugs listed below do not have a unique HCPCS code. It may still be considered correct coding to list these drugs under a "not otherwise classified" or "unclassified" HCPCS code (i.e., J3490, J3590, C9399; J9999) other than the one designated in this table. Regardless of which HCPCS code is reported with that listed drug, the drug remains non-covered.