Medicare Benefit Policy Manual (Pub. 100-02), Ch. 15 § 50.4.4.1
Antigens
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.)