Article - Process for Determining Self-Administered Drug Exclusions – Medical Policy Article (A52535)

CMS National Coverage PolicyN/AArticle TextThe Centers for Medicare and Medicaid Services (CMS) published guidelines instructing contractors to develop a process to determine whether a drug or biological is usually self-administered and excluded from payment. (See CMS Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 50.2). These instructions include the following: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 patients who take them. Section 112 of the Benefits, Improvements & Protection Act of 2000 ( BIPA) amended sections 1861 (s)(2)(A) and 1861 (s)(2)(B) of the[Social Security]Act 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."The term "administered" refers only to the physical process by which the drug enters the patient's body. It does not refer to whether the process is supervised by a medical professional (for example, to observe proper technique or side-effects of the drug). 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. For the purpose of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug.Contractors are further instructed to make this determination on a drug-by-drug basis, not on a beneficiary-by-beneficiary basis."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. 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.Evidence Criteria for applying the Medicare Self-Administered Drug Exclusion:Peer reviewed medical literatureStandards of medical practiceEvidence-based practice guidelinesFDA approved labelPackage insertDrug compendia referencesSelf-administration utilization statisticsAcute:For the purpose of determining whether a drug is usually self-administered, an acute condition means a condition that begins over a short time period, is likely to be of short duration and/or the expected course of treatment is for a short, finite interval. A course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered acute.Usually: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 and you may not make any Medicare payment for it.Drugs NOT Usually Self-administered:Drugs delivered intravenously may usually be presumed not usually self-administeredDrugs delivered intramuscularly may usually be presumed not usually self-administeredDrug Usually Self-administered:Drugs delivered subcutaneously may be usually presumed self-administeredDrugs delivered by other routes of administration such as oral, suppositories, and topical medications are all considered to be usually self-administeredNotice of Non-Covered DrugsContractors must provide notice 45 days prior to the date that these drugs will not be covered. During the 45-day time period, contractors will maintain existing medical review and payment procedures. After the 45-day notice, contractors may deny payment for the drugs subject to the notice.CMS further provided that Part A intermediaries or Part A MACs may opt to adopt the determinations of the Part B MACs within their jurisdiction(s). In the interest of providing consistent coverage for all providers within each state, the CGS Administrators, LLC Part A MACs will adopt the coverage decisions for injectable drugs subject to the self-administered drug exclusion as determined by the Part B MAC in each respective state. HCPCS codes for the same drugs that apply only to providers that bill the Part A MAC (e.g., HCPCS codes used for drugs billable under the Outpatient Prospective Payment System [OPPS]) are included when applicable. The list of drugs excluded from Medicare coverage as self-administered drugs can be accessed on our contractor Web site at www.cgsmedicare.com. It can also be found on the Medicare Coverage Database at www.cms.gov/mcd.