Page 54 - Medicare Benefit Policy Manual

supervision of a physician in the proper technique for self-administration. Medicare will
no longer pay for such doses. In addition, A/B MACs (A) may no longer pay for any
drug when it is administered on an outpatient emergency basis, if the drug is excluded
because it is usually self-administered by the patient.

D. Definition of Acute Condition

For the purposes 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 2 weeks, regardless of
frequency or route of administration, is considered acute. Evidence to support this may
include Food and Drug Administration (FDA) approval language, package inserts, drug
compendia, and other information.

E. By the Patient

The term “by the patient” means Medicare beneficiaries as a collective whole. The A/B
MAC (B) includes only the patients themselves and not other individuals (that is,
spouses, friends, or other care-givers are not considered the patient). The determination
is based on whether the drug is self-administered by the patient a majority of the time that
the drug is used on an outpatient basis by Medicare beneficiaries for medically necessary
indications. The A/B MAC (B) ignores all instances when the drug is administered on an
inpatient basis.

The A/B MAC (B) makes this determination on a drug-by-drug basis, not on a
beneficiary-by-beneficiary basis. In evaluating whether beneficiaries as a collective
whole self-administer, individual beneficiaries who do not have the capacity to self-
administer any drug due to a condition other than the condition for which they are taking
the drug in question are not considered. For example, an individual afflicted with
paraplegia or advanced dementia would not have the capacity to self-administer any
injectable drug, so such individuals would not be included in the population upon which
the determination for self-administration by the patient was based. Note that some
individuals afflicted with a less severe stage of an otherwise debilitating condition would
be included in the population upon which the determination for “self-administered by the
patient” was based; for example, an early onset of dementia.

F. Evidentiary Criteria

A/B MACs (A), (B), and (HHH), and DME MACs are only required to consider the
following types of evidence: peer reviewed medical literature, standards of medical
practice, evidence-based practice guidelines, FDA approved label, and package inserts.
A/B MACs (A), (B), and (HHH), and DME MACs may also consider other evidence
submitted by interested individuals or groups subject to their judgment.