Self Administered Drug Exclusions
Reference: AR – LSB 081408

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. Included in this article is a list of injectable drugs that Pinnacle Business Solutions, Inc. (PBSI), has determined to be usually self-administered by the patient and are, therefore, not reimbursable by Medicare.

For the purposes of this article, 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. Only injectable (including intravenous) drugs are eligible for inclusion under the "incident to" benefit.

Additionally, 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 the contractor may not make any Medicare payment for it.

In making a determination for exclusion (non-coverage) of injectable drugs "incident to" a physician’s service, the following criteria will be considered. If a drug has multiple indications, then the final determination will be based on the weighted average of the determination for each indication:

1. Nature of the Condition
   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.
    
2. Administration
   If it is not apparent on its face that a drug is or is not self-administered, the following presumptions will be made, absence evidence to the contrary:
   • Drugs delivered intravenously are not usually self-administered by the patient
   • Drugs delivered by intramuscular injection are not usually self-administered by the patient
   • Drugs delivered by subcutaneous injection are usually self-administered by the patient
      
3. Duration of Treatment
   A course of treatment consisting of scheduled injections lasting less than two weeks, regardless of frequency or route of administration, is considered acute and would usually be covered.
    
4. Frequency of Administration
   Drugs administered once or more per week are more likely to be self-administered by the patient.
    
5. Evidentiary Criteria
   Peer reviewed medical literature, standards of medical practice, evidence-based practice guidelines, the FDA approved label, and package inserts will be considered when determining if a drug is self-administered.
   
   The following codes are determined to be self-administered, and are not covered. Please note the exclusion effective date. Several codes have been added to the list with an exclusion effective date of October 15, 2008. This article is providing the required notice period that these codes will no longer by covered.

1. CMS Manual System, Pub 100-02 Medicare Benefit Policy Manual, Chapter 15, section 50.2, Change Request 5988 dated June 20, 2008.
2. CMS Manual System, Pub 100-04 Medicare Claims Processing Manual, Chapter 17, section 80.5, Change Request 5988 dated June 20, 2008.

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