Retired Local Coverage Determination (LCD)

Assays for Vitamins and Metabolic Function

L33418

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Palmetto GBA	A and B MAC	10112 - MAC B	J - J	Alabama
Palmetto GBA	A and B MAC	10212 - MAC B	J - J	Georgia
Palmetto GBA	A and B MAC	10312 - MAC B	J - J	Tennessee
Palmetto GBA	A and B and HHH MAC	11202 - MAC B	J - M	South Carolina
Palmetto GBA	A and B and HHH MAC	11302 - MAC B	J - M	Virginia
Palmetto GBA	A and B and HHH MAC	11402 - MAC B	J - M	West Virginia
Palmetto GBA	A and B and HHH MAC	11502 - MAC B	J - M	North Carolina

LCD Information

Document Information

LCD ID
L33418

LCD Title
Assays for Vitamins and Metabolic Function

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 12/10/2020

Revision Ending Date
01/28/2023

Retirement Date
01/28/2023

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 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.

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.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862 (a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

42 Code of Federal Regulations (CFR) §410.32 indicates that diagnostic tests are payable only when ordered by the physician who is treating the beneficiary for a specific medical problem and who uses the results in such treatment.

Federal Register, Vol. 66, No. 226, November 23, 2001, pp. 58788–58890 addresses coverage and administrative policies for clinical diagnostic laboratory services.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 6, §20.4.3 Coverage of Outpatient Diagnostic Services Furnished on or Before December 31, 2009

CMS Internet-Only Manual, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, §230.19 Levocarnitine for Use in the Treatment of Carnitine Deficiency in ESRD Patients

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Medicare considers vitamin assay panels (more than 1 vitamin assay) a screening procedure and therefore, non-covered. Similarly, assays for micronutrient testing for nutritional deficiencies that include multiple tests for vitamins, minerals, antioxidants and various metabolic functions are never necessary. Medicare reimburses for covered clinical laboratory studies that are reasonable and necessary for the diagnosis or treatment of an illness. Many vitamin deficiency problems can be determined from a comprehensive history and physical examination. Any diagnostic evaluation should be targeted at the specific vitamin deficiency suspected and not a general screen. Most vitamin deficiencies are nutritional in origin and may be corrected with supplemented vitamins.

Most vitamin deficiencies are suggested by specific clinical findings. The presence of those specific clinical findings may prompt laboratory testing for evidence of a deficiency of that specific vitamin. Certain other clinical states may also lead to vitamin deficiencies (malabsorption syndromes, etc).

Limitations:

For Medicare beneficiaries, screening tests are governed by statute. Vitamin testing may not be used for routine screening.

Once a beneficiary has been shown to be vitamin deficient, further testing is medically necessary only to ensure adequate replacement has been accomplished. Thereafter, annual testing may be appropriate depending upon the indication and other mitigating factors.

Assays of selenium, functional intracellular analysis, or total antioxidant function are non-covered services. Assays of vitamin testing, not otherwise classified, are not covered since all clinically relevant vitamins have specific assays.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

General Information

Associated Information

Documentation Requirements

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

Utilization Guidelines

Medicare will not cover more than 1 test per year, per beneficiary except as noted below.

Certain tests may exceed the stated frequencies, when accompanied by a diagnosis fitting the exception description for exceeding the once per annum maximum.

Carnitine may be tested up to 3 times per year to account for baseline assay followed by evaluations at 6-month increments (adapted from “Levocarnitine” NCD).
Vitamin B-12 and folate can be tested up to 4 times per year for malabsorption syndromes or deficiency disorders.
Vitamin B-12 can only be tested more frequently than 4 times per year for postsurgical malabsorption.
25-OH Vitamin D-3 may be tested up to 4 times per year for Vitamin D deficiencies.
Fibrinogen, antigen may be tested up to 4 times per year for low platelet diagnoses.
Medicare will not cover more than 2 high-sensitivity C-reactive protein tests per year per beneficiary. This allows for baseline testing and 6-month follow-up tests for statin therapeutic management.
The same frequency edit (2 tests per year per beneficiary) will be applied to Lipoprotein-associated phospholipase A₂ (Lp-PLA₂) used in the management of patients with coronary artery disease.
Lymphocyte transformation assays will not be subjected to any frequency edits.

Sources of Information
N/A

Bibliography

Albert MA, Glynn RJ, Wolfert RL, Ridker PM. The effect of statin therapy on lipoprotein associated phospholipase A2 levels. Atherosclerosis. 2005;182(1):193–198.

American College of Cardiology and American Heart Association. ACC/AHA 2002 guideline update for management of patients with chronic stable angina. Circulation. 2003;107(1):149-158.

Hackam DG, Anand SS. Emerging risk factors for atherosclerotic vascular disease. JAMA. 2003;290(7):932–940.

Clarke R, Collins R, Lewington DP, et al. Homocysteine and risk of ischemic heart disease and stroke: A meta-analysis. JAMA. 2002;288(16):2015–2022.

Jacobs DS, DeMott WR, Oxley DK. Jacobs and DeMott. Laboratory Test Handbook with Key Word Index. 5th Edition.

Kowalski RJ, Post DR, Mannon RB, et al. Assessing relative risks of infection and rejection: a meta-analysis using an immune function assay. Transplantation. 2006;82(5):663-668.

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation	Reasons for Change
01/28/2023	R20	This LCD is being retired because the information in this policy has been incorporated within the Vitamin D Assay Testing L39391 LCD.	LCD Being Retired
12/10/2020	R19	Under *CMS National Coverage Policy* added section headings to the regulations. Under *Sources of Information* citations were removed and moved under *Bibliography*, changes were made to citations to reflect AMA citation guidelines, and removed reference to Lab NCDs ICD-10 code list. Formatting, punctuation and typographical errors were corrected throughout the LCD. At this time 21^stCentury 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
10/10/2019	R18	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. Title XVIII of the Social Security Act, §1833(e) was removed from the *CMS National Coverage Policy* section of this LCD and placed in the related Billing and Coding: Assays for Vitamins and Metabolic Function A56485 article. At this time 21^stCentury 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
10/01/2019	R17	All coding located under the *Coding Information: Revenue Codes* section was removed and is included in the related Billing and Coding: Assays for Vitamins and Metabolic Function A56485 article as it was inadvertently left in the LCD with revision 16. All verbiage regarding billing and coding under the *Coverage Indications, Limitations, and/or Medical Necessity* section and the *Associated Information* section has been removed and is included in the related Billing and Coding: Assays for Vitamins and Metabolic Function A56485 article. At this time 21^stCentury 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	R16	All coding located in the *Coding Information* section has been moved into the related Billing and Coding for the Assays for Vitamins and Metabolic Function A56485 article and removed from this LCD. At this time 21^stCentury 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
12/12/2018	R15	Under *ICD-10 Codes that Support Medical Necessity Group 1: Codes* added M85.88. Under *ICD-10 Codes that Support Medical Necessity Group 4: Codes* added K90.9 and R74.8. This revision is due to a reconsideration request and has a retroactive effective date of 10/1/18. At this time 21^stCentury 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 Reconsideration Request
11/22/2018	R14	Under *Associated Information – Documentation Requirements* added the word “the” before “A/B MAC”. Under *Bibliography* changes were made to citations to reflect AMA citation guidelines. At this time 21^stCentury 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
11/12/2018	R13	Under *ICD-10 Codes that Support Medical Necessity Group 6: Codes* added ICD-10 codes Z77.018, Z13.83 and J63.2. At this time 21^stCentury 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.	Reconsideration Request
10/01/2018	R12	Under *ICD-10 Codes That Support Medical Necessity Group 8: Codes* deleted ICD-10 code E78.4 and added ICD-10 codes E78.41 and E78.49. This revision is due to the Annual ICD-10 Code Update and becomes effective October 1, 2018. At this time 21^stCentury 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
07/19/2018	R11	Under *ICD-10 Codes that Support Medical Necessity – Group 1 and Group 4* added ICD-10 Codes K91.1, K91.2 and K91.81. Under *ICD-10 Codes that Support Medical Necessity – Group 3* added ICD-10 Codes K91.1 and K91.81. This revision is retroactive for dates of service on and after 2/26/18. At this time 21^stCentury 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
05/24/2018	R10	Associated Information stated: “Fibrinogen, antigen (85385) may be tested up to four times per year for low platelet diagnoses (D47.3, D69.3, D69.41, D69.42, D69.59 and D69.9).” It should read D69.6 (thrombocytopenia, unspecified) instead of D69.9 (hemorrhagic condition, unspecified). Made the correction from D69.9 to D69.6.	Typographical Error
02/26/2018	R9	The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.	Change in Affiliated Contract Numbers
12/14/2017	R8	Removed Title XVIII of the Social Security Act, §1862 (a)(1)(D) Investigational or Experimental from CMS National Coverage Policy.	Other
10/01/2017	R7	Under *ICD-10 Codes That Support Medical Necessity Group 3: Codes* added ICD-10 codes F10.1, K91.30, K91.31, K91.32. Under *ICD-10 Codes That Support Medical Necessity Group 8: Codes* added ICD-10 codes E11.10, E11.11. 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.	Revisions Due To ICD-10-CM Code Changes
11/17/2016	R6	Added the following codes under Group 1: M85.811 M85.812 M85.821 M85.822 M85.831 M85.832 M85.841 M85.842 M85.851 M85.852 M85.861 M85.862 M85.871 M85.872	Reconsideration Request
10/01/2016	R5	ICD-10 code Changes: Group #3 (Added) K5221, K5222, K5229, K523, K52831, K52832, K581 and K582 Group #4 (Added) G5783, G5793 and G6182 Group #8 (Added) E7800 and E7801	Revisions Due To ICD-10-CM Code Changes
01/29/2016	R4	Under *ICD-10 Codes That Support Medical Necessity* added the following ICD-10 codes to Group 7 to support the medical necessity of CPT codes 86141 & 83698: I70.0, I70.1, I70.201, I70.202, I70.203, I70.208, I70.209, I70.211, I70.212, I70.213, I70.218, l70.219, I70.221, I70.222, I70.223, I70.228, I70.229, I70.231, I70.232, I70.233, I70.234, I70.235, I70.238, I70.239, I70.241, I70.242, I70.243, I70.244, I70.245, I70.248, l70.249, I70.25, I70.261, I70.262, I70.263, I70.268, I70.269, I70.291, I70.292, I70.293, I70.298, I70.299, I70.301, I70.302, I70.303, I70.308, I70.309, I70.311, I70.312, I70.313, l70.318, I70.319, I70.321, I70.322, I70.323, I70.328, I70.329, I70.331, I70.332, I70.333, I70.334, I70.335, I70.8, I70.90, I70.91, and I70.92.	Provider Education/Guidance Request for Coverage by a Practitioner (Part B) Automated Edits to Enforce Reasonable & Necessary Requirements Revisions Due To ICD-10-CM Code Changes
10/01/2015	R3	Corrected grouping error in ICD-10 codes. Moved M89.9 and M94.9 to from Group 3 to Group 1. Moved G25.9 from Group 4 to Group 3.	Other (ICD-10 Conversion)
10/01/2015	R2	Under *ICD-10 Codes That Support Medical Necessity* added ICD-10 codes inadvertently omitted from the LCD: Group 1: N18.3 N18.4 N18.5 N18.6 N25.81 Group 3: M89.9 M94.9 E46 D53.9 Group 4: G25.9 Group 5: D69.49 Group 6: T86.891 T86.899 T86.5	Other (ICD10 conversion)
10/01/2015	R1	Under CMS National Coverage Policy italicized titles of manuals. Completed title of Medicare National Coverage Determinations Manual. Under Sources of Information and Basis for Decision revised citations to AMA format. Removed reference to Program Memorandum Transmittal AB-02-165 as this is already cited in CMS National Coverage Policy section. Corrected hyperlink to NCD reference. Corrected page numbers for American College of Cardiology and American Heart Association reference.	Provider Education/Guidance Other (Maintenance Annual Validation)

Associated Documents

Attachments
N/A

Related Local Coverage Documents
Articles
A56485 - Billing and Coding: Assays for Vitamins and Metabolic Function

Updated On	Effective Dates	Status
01/28/2023	12/10/2020 - 01/28/2023	Retired	You are here
12/04/2020	12/10/2020 - N/A	Superseded	View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

Assays for Vitamins
Vitamins
Metabolic Function

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Assays for Vitamins and Metabolic Function

Contractor Information

LCD Information

Document Information

CMS National Coverage Policy

Coverage Guidance

General Information

Revision History Information

Associated Documents

Keywords

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