LCD L33967

Coverage Guidance

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Vitamin B12 Injections. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Vitamin B12 Injections and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

• CMS IOM Publication 100-02, Medicare Benefit Policy Manual,

• Chapter 1, Section 30 Drugs and Biologicals

• Chapter 6, 20.5.3 Coverage of Outpatient Therapeutic Services Incident to a Physician’s Service Furnished on or After January 1, 2020 – Changes to Supervision Requirements

• Chapter 15, Section 50 Drugs and Biologicals and Section 60 Services and Supplies

• 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

• CMS IOM Publication 100-04, Medicare Claims Processing Manual,

• Chapter 17 Drugs and Biologicals

• Chapter 23, Section 20.9 National Correct Coding Initiative (CCI)

• CMS IOM Publication 100-08, Medicare Program Integrity Manual,

• Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

• Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Indications and Limitations of Coverage

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.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Associated Information

Please refer to the related Local Coverage Article: Billing and Coding: Vitamin B12 Injections (A57755) for documentation requirements, utilization parameters and all coding information as applicable.

Bibliography

N/A