Summary Of Evidence

N/A

Analysis of Evidence

N/A

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

Vitamin B₁₂ is essential for the formation of red blood cells and is used in the treatment of diseases in which there is defective red cell formation.

Covered Indications

Vitamin B₁₂ injection will be considered medically reasonable and necessary under the following circumstances: 

• Vitamin B₁₂ administration by injection is a covered benefit accepted as medically necessary when the beneficiary has a history of a low serum B₁₂ or conditions causing or caused by a low serum B₁₂. 

In addition, vitamin B₁₂ will be considered medically reasonable and necessary when administered as an adjunct to pemetrexed or pralatrexate treatment as follows: 

• For pemetrexed patients, patients must receive one intramuscular injection of vitamin B₁₂ during the week preceding the first dose of pemetrexed and every three cycles thereafter
• For pralatrexate patients, supplement patients with vitamin B₁₂ 1 mg intramuscularly no more than 10 weeks prior to the first dose of pralatrexate, and every 8-10 weeks thereafter

Subsequent vitamin B₁₂ injections may be given the same day as either pemetrexed or pralatrexate.

Limitations

Please refer to CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, Section 150.6 Vitamin B₁₂ Injections to Strengthen Tendons, Ligaments, etc., of the Foot regarding non coverage. 

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.