Page 52 - Medicare Benefit Policy Manual

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 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”.

A. Policy

A/B MACs (A), (B), and (HHH), are instructed to follow the instructions below when
applying the exclusion for drugs that are usually self-administered by the patient. Each
individual A/B MAC (A), (B), or (HHH) must make its own individual determination on
each drug. A/B MACs (A), (B), and (HHH) must continue to apply the policy that not
only the drug is medically reasonable and necessary for any individual claim, but also
that the route of administration is medically reasonable and necessary. That is, if a drug
is available in both oral and injectable forms, the injectable form of the drug must be
medically reasonable and necessary as compared to using the oral form.

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.

B. Administered

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.

C. 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 the A/B MAC (A), (B), or (HHH) may not make any
Medicare payment for it. In arriving at a single determination as to whether a drug is
usually self-administered, A/B MACs (A), (B), and (HHH) should make a separate