Page 61 - Medicare Benefit Policy Manual

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).

50.4.4 - Payment for Antigens and Immunizations
(Rev. 1, 10-01-03)

50.4.4.1 - Antigens
(Rev. 186, Issued: 04-16-14, Effective: 01-01 01, Implementation: 05-12-14)

Payment may be made for a reasonable supply of antigens that have been prepared for a
particular patient if: (1) the antigens are prepared by a physician who is a doctor of
medicine or osteopathy, and (2) the physician who prepared the antigens has examined
the patient and has determined a plan of treatment and a dosage regimen.

Antigens must be administered in accordance with the plan of treatment and by a doctor
of medicine or osteopathy or by a properly instructed person (who could be the patient)
under the supervision of the doctor. The associations of allergists that CMS consulted
advised that a reasonable supply of antigens is considered to be not more than a 12-month
supply of antigens that has been prepared for a particular patient at any one time. The
purpose of the reasonable supply limitation is to assure that the antigens retain their
potency and effectiveness over the period in which they are to be administered to the
patient. (See §§20.2 and 50.2.)

50.4.4.2 - Immunizations
(Rev. 11905; Issued:03- 16-23; Effective:10-19-22; Implementation: 04-17-23)

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, such as anti-rabies treatment,
tetanus antitoxin or booster vaccine, botulin antitoxin, antivenin
sera, or immune globulin. In the absence of injury or direct
exposure, preventive immunization (vaccination or inoculation)
against such diseases as smallpox, polio, diphtheria, etc.is not
covered. However, pneumococcal, hepatitis B, and influenza virus
vaccines are exceptions to this rule. (See items A, B, and C below.)
In cases where a vaccination or inoculation is excluded from
coverage, related charges are also not covered.

A. Pneumococcal Pneumonia Vaccinations

1. Background and History of Coverage:

Section 1861(s)(10)(A) of the Social Security Act and regulations at 42 CFR