L29309-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Vitamin B 12 Injections (L29309)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29309

LCD Title

Vitamin B 12 Injections

Contractor's Determination Number J3420

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 04/06/2010 Revision Ending Date

CMS National Coverage Policy CMS Pub 100-2, 15, § 50

CMS Pub 100-2, 16, § 100

CMS Pub 6, 45-4

Indications and Limitations of Coverage and/or Medical Necessity

Vitamin B 12 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.

Vitamin B 12 administration by injection is a covered benefit accepted as medically necessary when the beneficiary has a history of a low serum B 12 or conditions causing or caused by a low serum B 12.

In addition, vitamin B 12 will be considered medically necessary when administered as an adjunct to Alimta&reg or Folotyn&#8482 treatment as follows:

• For Alimta&reg patients, patients must receive one intramuscular injection of vitamin B 12 during the week preceding the first dose of Alimta&reg and every three cycles thereafter

• For Folotyn&#8482 patients, supplement patients with vitamin B 12 1 mg intramuscularly no more than 10 weeks prior to the first dose of Folotyn&#8482, and every 8-10 weeks thereafter

• Subsequent vitamin B 12 injections may be given the same day as either Alimta&reg or Folotyn&#8482

Vitamin B 12 injections (J3420) used to strengthen tendons, ligaments, etc. of the foot are considered investigational and are therefore noncovered.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

J3420 INJECTION, VITAMIN B-12 CYANOCOBALAMIN, UP TO 1000 MCG

ICD-9 Codes that Support Medical Necessity

260 KWASHIORKOR

261 NUTRITIONAL MARASMUS

263.1 MALNUTRITION OF MILD DEGREE

263.2 ARRESTED DEVELOPMENT FOLLOWING PROTEIN-CALORIE MALNUTRITION

263.8 OTHER PROTEIN-CALORIE MALNUTRITION

263.9 UNSPECIFIED PROTEIN-CALORIE MALNUTRITION

266.2 OTHER B-COMPLEX DEFICIENCIES

281.1 PERNICIOUS ANEMIA

281.2 OTHER VITAMIN B12 DEFICIENCY ANEMIA

281.3 FOLATE-DEFICIENCY ANEMIA

281.4 OTHER SPECIFIED MEGALOBLASTIC ANEMIAS NOT ELSEWHERE CLASSIFIED

281.9 UNSPECIFIED DEFICIENCY ANEMIA

336.2 SUBACUTE COMBINED DEGENERATION OF SPINAL CORD IN DISEASES CLASSIFIED ELSEWHERE

535.10 ATROPHIC GASTRITIS (WITHOUT HEMORRHAGE)

564.2 POSTGASTRIC SURGERY SYNDROMES

577.1 CHRONIC PANCREATITIS 579.0 - 579.9 opens in new

window CELIAC DISEASE - UNSPECIFIED INTESTINAL MALABSORPTION

995.29 UNSPECIFIED ADVERSE EFFECT OF OTHER DRUG, MEDICINAL AND BIOLOGICAL SUBSTANCE

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Progress notes and laboratory test results indicating present or past values of serum B 12 as well as supporting the treatment for the identified diagnosis(es) need to be maintained and made available upon request in the event post-payment review is required. A serum B 12 level is not required if vitamin B 12 is administered in conjunction with Alimta® or Folotyn&#8482. The medical record should reflect the patient is being treated with Alimta® or Folotyn&#8482.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision

Allos Therapeutics. (2009)Folotyn&#8482 prescribing information.

Eli Lilly and Company. (2004). Prescribing information. This document was utilized to determine the indications and limitations of coverage associated with Alimta®.

Taber's Cyclopedic Medical Dictionary

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 05/01/2010 Revision History Number 1

Revision History Explanation Revision Number 1 Start Date of Comment Period:N/A

Start Date of Notice Period:05/01/2010 Revised Effective Date 04/06/2010

LCR B2010-034

April 2010 Update

Explanation of Revision: Revised the indications and limitations of coverage to add language allowing Folotyn™.

In addition, added language regarding frequency of the Vitamin B12 injections per the FDA labels. Added language under documentation requirements regarding serum B12 testing for Folotyn™. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29309) replaces LCD L6740 as the policy in notice. This document (L29309) is effective on 02/02/2009.

Reason for Change