This notice sets forth the process GHI Medicare uses to determine that a drug must be excluded from Medicare payment since it is "usually self-administered by the patient." It is based primarily on the following Medicare publications:

Transmittal AB-02-072, Change Request 2200, dated May 15, 2002, http://www.cms.gov/manuals/pm_trans/AB02072.pdf. Transmittal AB-02-139, Change Request 2311, dated October 11, 2002, http://www.cms.gov/manuals/pm_trans/AB02139.pdf

The table at the end of this notice lists specific drugs excluded from payment on this basis as of January 1, 2006.

The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs furnished incident to a physician’s service provided the drugs are not "usually self-administered by the patients" who take them. Drugs "usually self-administered by the patient" are thus excluded from payment. 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. The term "by the patient" refers to Medicare beneficiaries as a collective whole and includes only patients themselves, and not any other individuals such as spouses, friends, or other care-givers. Only injectable (including intravenous) drugs are eligible for inclusion under the “incident to” benefit. Other routes of administration including, but not limited to, oral drugs, suppositories, or topical medications are all considered to be "usually self-administered by the patient," and are thus excluded from payment and consideration under this process.

Each individual drug determination is based on whether the drug is "self-administered by the patient" greater than 50% of the time the drug is used on an outpatient basis by Medicare beneficiaries for medically necessary indications. Inpatient administration is excluded from this consideration. For drugs with several medical indications, it may be necessary for GHI Medicare to first determine the relative proportion of self-administration for each indication, and then calculate a weighted average to determine if the drug is overall "usually self-administered" or not.

The final determination for each drug applies uniformly to all patients, clinical circumstances and routes of administration, even those that may be considered to require physician administration, such as in an emergency or teaching a patient to self-administer. Inversely, drugs determined to be not usually self-administered by the patient are covered even for uses that can be self-administered. However, payment still requires that the drug be furnished incident to a physician’s service and be reasonable and necessary for the condition treated. No payment may be made for a covered (non-excluded) drug that is self-administered. No payment may be made for a drug purchased by the beneficiary and then administered by the physician.

In making determinations in accordance with the above, GHI Medicare will also rely upon the following considerations:

1. Determination of Self-Administration "Apparent on Its Face": For certain injectable drugs, it may 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. Evidentiary Criteria: GHI Medicare is required to consider the following types of evidence in making its determinations: peer reviewed medical literature, standards of medical practice, evidence-based practice guidelines, FDA approved labeling information and package inserts. GHI Medicare may, at its own discretion consider other evidence submitted by interested individuals or groups.
3. Because reliable statistical information on the extent of self-administration by the patient may not always be available, the following presumptions may be applied:
   1. Absent evidence to the contrary, drugs delivered intravenously are presumed to be not usually self-administered by the patient;
   2. Absent evidence to the contrary, drugs delivered by intramuscular injection are presumed to be not usually self-administered by the patient; (The depth and nature of the particular intramuscular injection may be considered in applying this presumption)
   3. Absent evidence to the contrary, drugs delivered by subcutaneous injection are presumed to be usually self-administered by the patient.
   For subcutaneous injections and, if needed for intramuscular injections, the following factors are considered in applying these presumptions:
   • Acute condition. – 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.
   • Frequency of administration – If the drug is administered once per month, it is less likely to be self-administered by the patient. If a drug is administered one or more times per week, it is likely the drug is self-administered by the patient.
   Following the above guidelines the drugs identified below have been determined, to be "usually self-administered" by the patients who use them and are excluded from payment. Publication on this list begins a 45-day notice period whereby existing medical review and payment procedures will remain in effect. After the 45-day notice period ends, claims for payment of these drugs will be denied in all circumstances. The list will be reviewed periodically and updated as further determinations are made. Therefore, the absence of any particular drug on the exclusion list does not mean, at some later date, the drug might be deemed excluded based on the guidelines listed above.