Page 53 - Medicare Benefit Policy Manual

determination for each indication for a drug as to whether that drug is usually self-
administered.

After determining whether a drug is usually self-administered for each indication, A/B
MACs (A), (B), or (HHH) should determine the relative contribution of each indication
to total use of the drug (i.e., weighted average) in order to make an overall determination
as to whether the drug is usually self-administered. For example, if a drug has three
indications, is not self-administered for the first indication, but is self administered for the
second and third indications, and the first indication makes up 40 percent of total usage,
the second indication makes up 30 percent of total usage, and the third indication makes
up 30 percent of total usage, then the drug would be considered usually self-administered.

Reliable statistical information on the extent of self-administration by the patient may not
always be available. Consequently, CMS offers the following guidance for each A/B
MAC (A)’s, (B)’s, or (HHH)’s consideration in making this determination in the absence
of such data:

1. Absent evidence to the contrary, presume that drugs delivered intravenously are not
usually self-administered by the patient.

2. Absent evidence to the contrary, presume that drugs delivered by intramuscular
injection are not usually self-administered by the patient. (Avonex, for example, is
delivered by intramuscular injection, not usually self-administered by the patient.) The
A/B MAC (A), (B), or (HHH) may consider the depth and nature of the particular
intramuscular injection in applying this presumption. In applying this presumption, A/B
MACs (A), (B), and (HHH) should examine the use of the particular drug and consider
the following factors:

3. Absent evidence to the contrary, presume that drugs delivered by subcutaneous
injection are self-administered by the patient. However, A/B MACs (A), (B), and (HHH)
should examine the use of the particular drug and consider the following factors:

A. Acute Condition - Is the condition for which the drug is used an acute
condition? If so, it is less likely that a patient would self-administer the drug. If
the condition were longer term, it would be more likely that the patient would
self-administer the drug.

B. Frequency of Administration - How often is the injection given? For
example, if the drug is administered once per month, it is less likely to be self-
administered by the patient. However, if it is administered once or more per
week, it is likely that the drug is self-administered by the patient.

In some instances, A/B MACs (B) may have provided payment for one or perhaps
several doses of a drug that would otherwise not be paid for because the drug is usually
self-administered. A/B MACs (B) may have exercised this discretion for limited
coverage, for example, during a brief time when the patient is being trained under the