TN 2 (11-22)

HI 00610.110 Drugs and Biologicals

A. General

Drugs and biologicals are covered only if they are of the type that cannot be self-administered; they are not excluded as immunizations; they are reasonable and necessary for the diagnosis or treatment of the illness or injury (see HI00620.010) and they are administered by the physician or by the physician's nurse under the physician's personal supervision and the charge, if any, for the drug is included in the physician's bill.

Prescription and nonprescription drugs purchased by or dispensed to a patient are not covered.

B. Self-Administered

Whether a drug or biological is of a type which cannot be self-administered is based on the usual method of administration of the form of the drug or biological as furnished by the physician. When a physician gives a patient pills or oral medication, these are excluded from coverage since in this form the drug is usually self-administered. Similarly, if a physician gives a patient an injection which is usually self-injected, this drug is excluded from coverage, unless administered in an emergency situation. When a physician injects a drug which is not usually self-injected, this drug is not subject to the self-administrable drug exclusion since it is not self-administrable in the form in which it was furnished to the patient.

Whole blood is a biological which cannot be self-administered and is covered when furnished incident to a physician's services. Payment may also be made for blood fractions if all coverage requirements above are satisfied.

C. Immunizations

Vaccinations or inoculations are excluded as “immunizations” unless they are directly related to the treatment of an injury or direct exposure to a disease or condition, for example, antirabies treatment, antivenin sera, tetanis antitoxin or booster vaccine, botulin antitoxin, or immune globulin. In the absence of injury or direct exposure preventive immunization (vaccination or inoculation) against such diseases as smallpox, polio, diptheria, etc, is not covered. (Flu injections are administered as a preventive measure and are excluded from coverage).

See HI 00610.306 regarding the coverage of pneumococcal vaccine and its administration.

D. Injections

The injection must be reasonable and necessary for diagnosis or treatment of an illness or injury for program payment to be made. If any of the following conditions prevail, the injection will not be covered:

  1. 1. 

    Injections which are not considered by accepted standards of medical practice to be indicated as a specific or effective treatment for the particular condition for which they are given. Vitamin B12 injections, for example, are specific therapy (and will be covered) for certain anemias, gastro-intestinal disorders and neuropathies. Vitamin B12 or any other injection not administered for one of these specific reasons, is excluded from coverage.

  2. 2. 

    Medications which are given for a purpose other than treatment of a particular condition, illness, or injury. For example, the entire charge for vitamin injections given simply for the general good and welfare of the patient and not as accepted therapy for a particular illness.

  3. 3. 

    Injections which are not considered an indicated method of administration according to accepted standards of medical practice for the condition for which given.

  4. 4. 

    Medications administered for treatment of a disease which exceed the frequency or duration of injections indicated by accepted standards of medical practice as an appropriate level of care for that condition, unless there are extenuating circumstances.

For example, scientific studies have shown that an injection of vitamin B12 at a dose of from 100 to 1,000 micrograms no more frequently than once monthly is the accepted, necessary, and reasonable dosage schedule for maintenance treatment for an individual with pernicous anemia. More frequent injections would be appropriate in the initial or acute phase of the disease until it has been determined through laboratory tests that the patient can be sustained on the maintenance dosage.

Another example: Standard medical practice indicates the use of parental penicillin or other antibiotics for the initiation of, but not for the entirety of, the course of treatment for an infectious disease. The entire charge for these penicillin injections (those exceeding the initial standard dosage) is excluded from coverage unless there are special medical circumstances which justify the additional injections.


To Link to this section - Use this URL:
http://policy.ssa.gov/poms.nsf/lnx/0600610110
HI 00610.110 - Drugs and Biologicals - 11/23/2022
Batch run: 11/23/2022
Rev:11/23/2022