Page 60 - Medicare Benefit Policy Manual

50.4.3 - Examples of Not Reasonable and Necessary
(Rev. 1, 10-01-03)
B3-2049.4

Determinations as to whether medication is reasonable and necessary for an individual
patient should be made on the same basis as all other such determinations (i.e., with the
advice of medical consultants and with reference to accepted standards of medical
practice and the medical circumstances of the individual case). The following guidelines
identify three categories with specific examples of situations in which medications would
not be reasonable and necessary according to accepted standards of medical practice:

1. Not for Particular Illness

Medications given for a purpose other than the treatment of a particular condition, illness,
or injury are not covered (except for certain immunizations). Charges for medications,
e.g., vitamins, given simply for the general good and welfare of the patient and not as
accepted therapies for a particular illness are excluded from coverage.

2. Injection Method Not Indicated

Medication given by injection (parenterally) is not covered if standard medical practice
indicates that the administration of the medication by mouth (orally) is effective and is an
accepted or preferred method of administration. For example, the accepted standard of
medical practice for the treatment of certain diseases is to initiate therapy with parenteral
penicillin and to complete therapy with oral penicillin. A/B MACs (B) exclude the entire
charge for penicillin injections given after the initiation of therapy if oral penicillin is
indicated unless there are special medical circumstances that justify additional injections.

3. Excessive Medications

Medications administered for treatment of a disease and which exceed the frequency or
duration of injections indicated by accepted standards of medical practice are not
covered. For example, the accepted standard of medical practice in the maintenance
treatment of pernicious anemia is one vitamin B-12 injection per month. A/B MACs (B)
exclude the entire charge for injections given in excess of this frequency unless there are
special medical circumstances that justify additional injections.

A/B MACs (B) will supplement the guidelines as necessary with guidelines concerning
appropriate use of specific injections in other situations. They will use the guidelines to
screen out questionable cases for special review, further development, or denial when the
injection billed for would not be reasonable and necessary. They will coordinate any
type of drug treatment review with the Quality Improvement Organization (QIO).

If a medication is determined not to be reasonable and necessary for diagnosis or
treatment of an illness or injury according to these guidelines, the A/B MAC (B) or DME