Vitamin B-12 Medicare Coverage Guidelines

Although drugs and biologicals are specifically excluded from coverage by the statute (§1861(m)(5) of the Social Security Act, the services of a nurse that are required to administer the medications safely and effectively may be covered if they are reasonable and necessary to the treatment of the illness or injury.

Injections
Intravenous, intramuscular, or subcutaneous injections and infusions, and hypodermoclysis or intravenous feedings require the skills of a licensed nurse to be performed (or taught) safely and effectively. Where these services are reasonable and necessary to treat the illness or injury, they may be covered. For these services to be reasonable and necessary, the medication being administered must be accepted as safe and effective treatment of the patient's illness or injury, and there must be a medical reason that the medication cannot be taken orally. Moreover, the frequency and duration of the administration of the medication must be within accepted standards of medical practice, or there must be a valid explanation regarding the extenuating circumstances to justify the need for the additional injections.

Vitamin B-12 injections are considered specific therapy only for the following conditions:

  • Specified anemias:
    Pernicious anemia: For a patient with pernicious anemia caused by a B-12 deficiency, intramuscular or subcutaneous injection of vitamin B-12 at a dose of from 100 to 1000 micrograms no more frequently than once monthly is the accepted reasonable and necessary dosage schedule for maintenance treatment.

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 a maintenance dose.

Megaloblastic anemias

Macrocytic anemias

Fish tapeworm anemia

  • Specified gastrointestinal disorders:
    Gastrectomy

Malabsorption syndromes such as sprue and idiopathic steatorrhea

Surgical and mechanical disorders such as resection of the small intestine, strictures, anastomosis and blind loop syndrome

  • Certain neuropathies:
    Posterolateral sclerosis,

Other neuropathies associated with pernicious anemia, during the acute phase or acute exacerbation of a neuropathy due to malnutrition and alcoholism.

Reference: CMS Internet-Only Manuals (IOMs), Pub 100-02, Medicare Benefit Policy Manual, Chapter 7, Section 40.1.2.4

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