Vitamin B12 or cyanocobalamin is essential to cell maturation, and deficiencies can result in certain characteristic anemias and neurological disorders. Cyanocobalamin, which is a synthetic, crystalline substance, is administered by subcutaneous injection to individuals with vitamin B12 deficiencies.

Vitamin B12 injections may be considered medically necessary in the treatment of vitamin B12 deficiency conditions, which include the following:

1. Anemias secondary to vitamin B12 deficiency (as shown by macrocytosis, low serum B12 , abnormal Schilling test), such as:

• Pernicious anemia;
• Fish tapeworm anemia;
• Macrocytic megaloblastic anemias resulting from gastrointestinal disorders;
• Anemias resulting from postgastrectomy;

2. Gastrointestinal disorders:

• Malabsorption syndromes such as sprue and idiopathic steatorrhea;
• Anemia resulting from small intestine resections, strictures, or blind loop syndromes;

3. Neuropathies secondary to vitamin B12 deficiency:

• Acute phase exacerbation due to malnutrition or alcoholism;
• Combined system degeneration (lateral sclerosis);

4. Dementias secondary to vitamin B12 deficiency.

In the absence of a vitamin B12 deficiency, other indications for vitamin B-12 injections are considered not medically necessary, including but not limited to, as a technique to lower homocysteine levels in an effort to reduce cardiovascular risk, strengthening tendons, ligaments, etc., of the foot, or in the treatment of arthritis, multiple sclerosis, senility, neuritis, diabetic neuropathy, shingles, leukemia, lupus erythematosus, or delayed growth.

Vitamin B12 injections administered during an office visit may be paid as part of the office visit.

When an injection is given without an office visit, it is billed using HCPCS code J3420.

2003 Update

A search of the literature based on the MEDLINE database for the period of 1998 to September 2003 was performed with a focus on the role of vitamin B12 injections as a technique to lower homocysteine levels, based on the results of epidemiologic studies that have show an association between homocysteine levels and cardiovascular risk. While several studies were identified that discussed vitamin B12 as a homocysteine-lowering therapy, all studies focused only on oral supplementation, and not vitamin B12 injections. (1-3) A variety of other studies specifically focused on patients receiving renal dialysis; elevated levels of homocysteine are common in this population. (4-6) Again, these studies focused on oral supplementation.

References:

1. Schnyder G, Roffi M, Flammer Y et al. Effect of homocysteine-lowering therapy on restenosis after percutaneous coronary intervention for narrowing in small coronary arteries. Am J Cardiol 2003; 91(10):1265-9.
2. Schnyder G, Roffi M, Flammer Y et al. Effect of homocysteine-lowering therapy with folic acid, vitamin B12, and vitamin B6 on clinical outcome after percutaneous coronary intervention: the Swiss Heart Study: a randomized controlled trial. JAMA 2002; 288(8):973-9.
3. Schnyder G, Roffi M, Pin R et al. Decreased rate of coronary restenosis after lowering of plasma homocysteine levels. N Engl J Med 2001; 345(22):1593-600.
4. Marcucci R, Zanazzi M, Bertoni E et al. Vitamin supplementation reduces the progression of atherosclerosis in hyperhomocysteinemic renal-transplant recipients. Transplantation 2003; 75(9):1551-5.
5. Amadottir M, Hultberg B. The effect of vitamin B12 on total plasma homocysteine concentration in folate-replete hemodialysis patients. Clin Nephrol 2003; 59(3):186-9.
6. Manns B, Hyndman E, Burgess E et al. Oral vitamin B(12) and high-dose folic acid in hemodialysis patients with hyper-homocyst(e)inemia. Kidney Int 2001; 59(3):1103-9.

Cyanocobalamin
Vitamin B12 Injections