Article - Self-Administered Drug Exclusion List: (A53032)

CMS National Coverage PolicyN/AArticle TextThe following SAD list is current as of 04/01/2024. However, the Noridian Contractor Medical Directors (CMDs) review the list on an ongoing basis and may update and republish at their discretion.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 by the patient. 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 Manual System, 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 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" and this A/B MAC will make no payment for the drug.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.Noridian 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) routeandIntramuscular (IM) routeof administration will be presumed to meet "not usually self-administered" requirements and therefore meets Medicare benefit category. We may consider the depth and nature of the particular injection in applying this presumption.Subcutaneous (SQ) routeof 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 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."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 CategoryTo determine if a drug meets the definition of usually self-administered on a Medicare population basis, as required by CMS instructions, Noridian will use the following process:Self-Administered Drug Process FlowThe 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 settingClinical indicationFDA/drug package insertsProvider specialtyEstimate the percent self-administered (greater than or less than 50 percent) by indication.Assess all information to determine whether the drug is covered under the benefit category and notify providers.If a drug meets the definition of "usually self-administered," Noridian 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 (ABN).Consideration of Objective EvidenceIn accordance with CMS instructions, Noridian will consider objective evidence when available to determine utilization of a particular drug.EvidenceNoridian welcomes any data and evidence that describes utilization of injectable drugs in the outpatient setting, specific to the Medicare beneficiary population as outlined above.Noridian 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, andPackage inserts.Noridian may also consider other evidence submitted by interested individuals or groups subject to their judgment.Noridian 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 InformationThese 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.Any miscellaneous HCPCS codes (J3490, J3590 and C9399) billed to Medicare for drugs that are listed in the Coding Table Information below will be denied.For certain injectable drugs, it will be "apparent on its face" that the nature of the condition(s) for which they are administered, or the usual course of treatment for those conditions (chronic vs acute), in and of itself dictate the mode of usual administration. For example, a course of treatment consisting of scheduled injections lasting less than two 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 Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, 50.2]Basis for Non-CoverageA. Apparent on its FaceB. Presumption: Long-Term Non-Acute AdministrationC. Acceptable Evidentiary Criteria AvailableRoute of Administration ModifierThe 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. Absent evidence 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 policyas stated in Medicare Benefit Policy Manual Chapter 15, section 50.2that 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.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 IM administration.CPT/HCPCS ModifiersGroup 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:JAIntravenous administrationJBSubcutaneous administrationProviders are reminded that no form of insulin, regardless of route of administration including intravenous, intramuscular, subcutaneous, or inhalation, is reimbursable by Medicare. [This includes J8499: Insulin, inhaled (Exubera), variable.]If a beneficiary's claim for a particular drug is denied because the drug is subject to the "self-administered drug exclusion," the beneficiary may appeal the denial. Because it is a "benefit category" denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Non-coverage (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 such an excluded drug.Provider and Physician AppealsThe hospital and a physician accepting assignment may appeal a denial under the provisions found in the IOM, Publication 100-04, Medicare Claims Processing Manual,Chapter 29, Section 200.Reasonable and NecessaryNoridian will make the determination of reasonable and necessary with respect to the medical appropriateness of the drug to treat the patient's condition and will continue to make the determination of whether the intravenous or injection form of a drug is appropriate, as opposed to the oral form. We will also continue to make the determination as to whether a physician's office visit was reasonable and necessary. However, while a physician's office visit may not be reasonable and necessary in a specific situation, the medical necessity of the injection will still be determined on its own merits based on this process for determining which drugs are usually self-administered.Sources IOM, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self-Administration of Drug or Biological Transmittal 123, CR 6950 dated April 30, 2010