CMS Pub. 100-02, ch. 15, § 50.4.3

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).