LCD - Vitamin B12 Injections (L33967) (2022)

Local Coverage Determination (LCD)

L33967

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Contractor Information

LCD Information

Document Information

LCD ID
L33967

LCD Title
Vitamin B12 Injections

Proposed LCD in Comment Period
N/A

Source Proposed LCD
N/A

Original Effective Date
For services performed on or after 10/01/2015

Revision Effective Date
For services performed on or after 01/01/2021

Revision Ending Date
N/A

Retirement Date
N/A

Notice Period Start Date
N/A

Notice Period End Date
N/A

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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 notrecommending 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.

Current Dental Terminology &copy 2021 American Dental Association. All rights reserved.

Copyright &copy 2013 - 2022, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission.No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA.AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution orderivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816.Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in anyproduct or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association.To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

CMS National Coverage Policy

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.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

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 (Rationale for Determination)

N/A

General Information

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.

Sources of Information

First Coast Service Options, Inc. reference LCD number – L29488

Allos Therapeutics. (2009) Folotyn™ (pralatrexate)prescribing information.

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

Taber's Cyclopedic Medical Dictionary

Bibliography

N/A

Revision History Information

Revision History DateRevision History NumberRevision History ExplanationReasons for Change
01/01/2021R5

LCD revised and published on 02/25/2021 effective for dates of service on and after 01/01/2021. In response to CR 12120, the IOM 100-02 Chapter 6 "Section 20.5.2" was updatedto “Section 20.5.3” in the IOM references section of the LCD. Also, minor formatting changes made throughout the LCD.

  • Other (IOM Manual change)
11/28/2019R4

Revision Number: 4
Publication: November 2019 Connection
LCR B2019-031

Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes,” “Revenue Codes,” “CPT/HCPCS Codes,” “ICD-10 Codes that Support Medical Necessity,” “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. In addition, the Social Security Act and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revision is based on CR 10901)
01/22/2019R3

Revision Number: 3
Publication: February 2019 Connection
LCR B2019-004

Explanation of Revision: Based on a review of the LCD, the registered trademark was added to the drug name “Alimta®” and outdated CMS sources were removed from the LCD. The effective date of this revision is based on date of service.

01/22/2019:At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revisions based on review)
02/08/2018R2

Revision Number: 2

Publication: February 2018 Connection

LCR B2018-003

Explanation of Revision: This LCD was revised in the “ICD-10 Codes that Support Medical Necessity” section of the LCD under “Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation:” to include an explanation that all the codes within the asterisked range from the first code to the last code apply. The effective date of this revision is based on process date.

02/08/2018: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
  • Public Education/Guidance
10/01/2016R1RRevision Number: 1 Publication: October 2016 Connection LCR B2016-097

Explanation of Revision: Based on CR 9677 (2017 ICD-10-CM Update) the LCD was revised. Deleted ICD-10-CM diagnosis code K90.4 and changed ICD-10-CM diagnosis code range K90.0 – K90.4 to read K90.0 – K90.49. The effective date of this revision is based on date of service.

  • Revisions Due To ICD-10-CM Code Changes

Associated Documents

Attachments
N/A

Related Local Coverage Documents
Articles
A57755 - Billing and Coding: Vitamin B12 Injections

Related National Coverage Documents
N/A

Public Versions

Updated OnEffective DatesStatus
02/19/202101/01/2021 - N/A Currently in EffectYou are here
Some older versions have been archived. Please visit theMCD Archive Site to retrieve them.

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The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare, Medicaidand the State Children's Health Insurance Programs, contracts with certain organizations to assist in the administration of theMedicare program. Medicare contractors are required to develop and disseminate Local Coverage Determinations (LCDs).CMS believes that the Internet is an effective method to share LCDs that Medicare contractors develop. While every effort hasbeen made to provide accurate and complete information, CMS does not guarantee that there are no errors in the information displayedon this web site. THE UNITED STATES GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES INTHE INFORMATION, PRODUCT, OR PROCESSES DISCLOSED HEREIN. Neither the United States Government nor its employees represent that use ofsuch information, product, or processes will not infringe on privately owned rights. In no event shall CMS be liable for direct, indirect,special, incidental, or consequential damages arising out of the use of such information, product, or process.

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