Medicare Benefit Policy Manual (Pub. 100-02), Ch. 15 § 50.4.3
Examples of Not Reasonable and Necessary
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 MAC excludes the entire charge (i.e., for
both the drug and its administration). Also, A/B MACs (B) exclude from payment any charges for other
services (such as office visits) which were primarily for the purpose of administering a noncovered injection
(i.e., an injection that is not reasonable and necessary for the diagnosis or treatment of an illness or injury).