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SUPERSEDED Local Coverage Determination (LCD)

Homocysteine Level, Serum

L34419

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34419
Original ICD-9 LCD ID
Not Applicable
LCD Title
Homocysteine Level, Serum
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 06/10/2021
Revision Ending Date
03/09/2024
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced 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 or derivative 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 any product 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‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act §1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member

42 CFR §410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements)

42 CFR §411.15(k)(11) excludes routine physical examinations

42 CFR §482.24 Conditions of participation: Medical record services

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.4.1 Diagnostic Services Defined

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Indications:

Elevated serum levels of the amino acid homocysteine are associated with increased risk of cardiovascular (CV) and cerebrovascular disease events as well as an increased risk of osteoporosis. Treatment of the elevated homocysteine level in the absence of an established causal relationship between hyperhomocysteinemia and these entities has been empiric supplementation with vitamin B-6, B-12 and folic acid. Hyperhomocysteinemia may also be present with vitamin B12 and folate deficiencies associated with anemia. In these instances the elevated homocysteine confirms the vitamin deficiency as the source of anemia.

No studies demonstrate that such vitamin supplementation, while lowering the serum homocysteine levels, also reduces the risks for CV or cerebrovascular events or osteoporosis. The Heart Outcomes Prevention Evaluation (HOPE) 2 investigators reported that "...combined daily administration...[of the vitamins] for 5 years had no beneficial effect on major vascular events in a high risk population with vascular disease." The Norwegian Vitamin Trial (NORVIT) investigators found that "Treatment with B vitamins did not lower the risk of recurrent CV disease after acute myocardial infarction. A harmful effect from combined B vitamin treatment was suggested." In their 2004 report, Lange H, et. al, reported that B vitamin supplementation to lower homocysteine levels, after coronary stenting, may increase the risk of in-stent restenosis and the need for target vessel revascularization.

  • Homocysteine levels will be covered by Medicare to confirm vitamin B12 or folate deficiency.
  • In the absence of evidence that treatment of hyperhomocysteinemia reduces CV events, this test can only be covered in patients with known vascular disease or risk thereof (based upon abnormal lipid metabolism, high blood pressure (BP) or diabetes mellitus (DM)) for the purpose of risk stratification. In this circumstance it will be covered only once per lifetime.

 Limitations:

  • When used to determine the risk of developing atherosclerotic CV disease, measurement of serum homocysteine levels in the absence of known vascular disease, hyperlipidemia or DM will be denied as screening.
  • Serum homocysteine levels for the evaluation of treatment of hyperhomocysteinemia in patients with CV risk factors will be denied as not medically necessary.
Summary of Evidence

N/A
Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
N/A
Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

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Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Documentation supporting medical necessity should be legible, maintained in the patient's medical record, and must be made available to the A/B MAC upon request.

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this Local Coverage Determination (LCD) (see Coverage Indications, Limitations and/or Medical Necessity). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Utilization Guidelines

When used for atherosclerotic CV disease risk stratification, measurement of serum homocysteine is considered to be medically necessary only once in a lifetime.
Sources of Information
N/A
Bibliography

Auer J, Lamm G, Eber B. Homocysteine as a predictive factor for hip fracture in older persons. N Engl J Med. 2004;351(10):1027-1030.

Bonaa KH, Njolstad I, Ueland PM, et al. Homocysteine lowering and cardiovascular events after acute myocardial infarction. N Engl J Med. 2006;354(15):1578-1588.

Gori AM, Corsi AM, Fedi S, et al. A proinflammatory state is associated with hyperhomocysteinemia in the elderly. Am J Clin Nutr. 2005;82(2):335-341.

Hansrani M, Stansby GP. Homocysteine lowering interventions for peripheral arterial disease and bypass grafts. Cochrane Database of Systemic Reviews. 2002;3:CD003285.

Jacques PF, Selhub J, Bostom AG, Wilson PW, Rosenberg IH. The effect of folic acid fortification on plasma folate and total homocysteine concentrations. N Engl J Med. 1999;340(19):1449-1454.

Kuzminski AM, Del Giacco EJ, Allen RH, Stabler SP, Lindenbaum J. Effective treatment of cobalamin deficiency with oral cobalamin. Blood. 1998;92(4):1191-1198.

Lange H, Suryapranata H, De Luca G, et al. Folate therapy and in-stent restenosis after coronary stenting. N Engl J Med. 2004;350(26):2673-2681.

Lonn E, Yusuf S, Arnold MJ, et al. Homocysteine lowering with folic acid and B vitamins in vascular disease: The heart outcomes prevention evaluation (HOPE) 2 investigators. N Engl J Med. 2006;354(15):1567-1577.

McLean RR, Jacques PF, Selhub J, et al. Homocysteine as a predictive factor for hip fracture in older persons. N Engl J Med. 2004;350(20):2042-2049.

Raisz LG. Homocysteine and osteoporotic fractures – culprit or bystander? N Engl J Med. 2004;350(20):2089-2090.

Raisz LG. Pathogenesis of osteoporosis: Concepts, conflicts, and prospects. J Clin Invest. 2005;115(12):3318-3325.

van Meurs JB, Dhonukshe-Rutten RA, Pluijm SM, et al. Homocysteine levels and the risk of osteoporotic fracture. N Engl J Med. 2004;350(20):2033-2041.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
06/10/2021 R14

Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were defined and inserted where appropriate throughout the LCD.

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
10/24/2019 R13

This LCD is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Homocysteine Level, Serum A56675 article. Typographical errors were corrected throughout the LCD.

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
07/04/2019 R12

All coding located in the Coding Information section has been moved into the related Billing and Coding: Homocysteine Level, Serum A56675 article and removed from the LCD. 

All verbiage regarding billing and coding under the Coverage Indications, Limitations and/or Medical Necessity section has been removed and is included in the related Billing and Coding: Homocysteine Level, Serum A56675 article. Formatting, punctuation and typographical errors were corrected throughout the LCD. 

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
04/11/2019 R11

Under CMS National Coverage Policy removed the first paragraph regarding quoted Internet Only Manual (IOM) text. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD. 

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
10/01/2018 R10

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes ICD-10 codes E78.4 and I63.8 have been deleted. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes ICD-10 codes E78.41, E78.49, I63.81, I63.89, I67.858 have been added. This revision is due to the Annual ICD-10 Code Update and becomes effective October 1, 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.

 
  • Revisions Due To ICD-10-CM Code Changes
05/03/2018 R9

Under CMS National Coverage Policy deleted the second and third sentence from the first paragraph. Under Coverage Indications, Limitations and/or Medical Necessity – Indications added the words “Heart Outcomes Prevention Evaluation” in front of the acronym HOPE and added the words “Norwegian Vitamin Trial” in front of the acronym NORVIT in the second paragraph. Under Coverage Indications, Limitations and/or Medical Necessity – Limitations added the word “for” before the word “suspected” in the first sentence of the third bullet. Under Coverage Indications, Limitations and/or Medical Necessity deleted Other Comments. Punctuation was corrected throughout the policy.

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
  • Typographical Error
01/29/2018 R8 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
10/01/2017 R7

Under ICD-10 Codes That Support Medical Necessity Group 1: Codes added ICD-10 codes E11.10, E11.11, I21.9, I21.A1, and I21.A9. The code description was revised for I63.211, I63.212, I63.22, I82.811, and I82.812. This revision is due to the 2017 Annual ICD-10 Code Updates.

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
  • Revisions Due To ICD-10-CM Code Changes
05/04/2017 R6 Under CMS National Coverage Policy - revised title for 42 CFR §410.32 ‘Indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements). Added title ‘Diagnostic Services Defined’ to CMS internet-only manual, Publication 100-02 Chapter 6 Section 20.4.1. Added title ‘Diagnosis Code Requirements’ to CMS internet-only manual Publication 100-08 Chapter 3 Section 3.4.1.3. Under Sources of Information and Basis for Decision – revised title of the eleventh article listed.
  • Provider Education/Guidance
  • Typographical Error
10/01/2016 R5 Under ICD-10 Codes that Support Medical Necessity deleted ICD-10 codes E10.321, E10.329, E10.331, E10.339, E10.341, E10.349, E10.351, E10.359, E11.321, E11.329, E11.331, E11.339, E11.341, E11.349, E11.351, E11.359, E13.321, E13.329, E13.331, E13.339, E13.341, E13.349, E13.351, E13.359 and E78.0. This revision is due to the Annual ICD-10 Code Update and becomes effective 10/1/16.
  • Provider Education/Guidance
  • Revisions Due To ICD-10-CM Code Changes
05/05/2016 R4 Under Coverage Indications, Limitations and/or Medical Necessity – Other Comments deleted the paragraph regarding Limitation On Liability (LOL). Under Sources of Information and Basis for Decision added an additional initial to the author’s name, G. Stansby.
  • Provider Education/Guidance
  • Other
10/01/2015 R3 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R2 Under CMS National Coverage Policy deleted the first sentence as it was redundant. Under Coverage Indications, Limitations and/or Medical Necessity-Limitations corrected ICD-9 to now read ICD-10 in the third bullet. Under Associated Information added the title “Documentation Requirements” and deleted “J11” in the first sentence of the first paragraph. Under Sources of Information and Basis for Decision corrected the author initials for Stansby in the following: Hansrani M, Stansby G. Homocysteine lowering interventions for peripheral arterial disease and bypass grafts. The Cochrane Database of Systematic Reviews. 2002;Issue 3. “The” was deleted from the journal title for the following: Lonn E, Yusuf S, Arnold MJ, et al. Heart outcomes prevention evaluation (HOPE) 2 investigators. Homocysteine lowering with folic acid and B vitamins in vascular disease. NEJM. 2006;354(15):1567-1577. Punctuation was corrected for the following: van Meurs JB, Dhonukshe-Rutten RA, Pluijm SM, et al. Homocysteine levels and the risk of osteoporotic fracture. NEJM. 2004;350(20):2033-2041.
  • Provider Education/Guidance
  • Other
10/01/2015 R1 Under Sources of Information and Basis for Decision added initial for author Stansby G to read “Stansby GP”. For article on Effective treatment of cobalamin deficiency with oral cobalamin, added “1” to page numbers so that numbers now read “1191-1198.”
  • Provider Education/Guidance
  • Other (Maintenance
    Annual Review)
N/A

Associated Documents

Attachments
N/A
Related Local Coverage Documents
Articles
A56675 - Billing and Coding: Homocysteine Level, Serum
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
01/19/2024 03/10/2024 - N/A Currently in Effect View
06/01/2021 06/10/2021 - 03/09/2024 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Serum Homocysteine

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