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Date Printed: August 23, 2017: 05:46 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-82000-23

Original Effective Date: 02/15/02

Reviewed: 05/25/17

Revised: 06/15/17

Subject: Measurement of Apolipoprotein B (apo B) and Apolipoprotein E (apo E) in Risk Assessment & Management of Cardiovascular Disease

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

APOLIPOPROTEIN B

Apolipoprotein B (apo B) is the major protein moiety of all lipoproteins, except for high-density lipoprotein (HDL). The most abundant form of apo B, large B or B100, constitutes the apo B found in LDL and very-low-density lipoproteins (VLDL). Because LDL and VLDL each contains 1 molecule of apo B, measurement of apo B reflects the total number of these atherogenic particles, 90% of which are LDL. Because LDL particles can vary in size and in cholesterol content, for a given concentration of LDL-C, there can be a wide variety in size and numbers of LDL particles. Thus, it has been postulated that apo B is a better measure of the atherogenic potential of serum LDL than LDL concentration.

APOLIPOPROTEIN E

Apolipoprotein E (apo E) is the primary apolipoprotein found in VLDLs and chylomicrons. Apo E is the primary binding protein for LDL receptors in the liver and is thought to play an important role in lipid metabolism. The apolipoprotein E (APOE) gene is polymorphic, consisting of 3 epsilon alleles (e2, e3, e4) that code for 3 protein isoforms, known as E2, E3, and E4, which differ from one another by 1 amino acid. These molecules mediate lipid metabolism through their different interactions with LDL receptors. The genotype of apo E alleles can be assessed by gene amplification techniques, or the APOE phenotype can be assessed by measuring plasma levels of apo E. It has been proposed that various APOE genotypes are more atherogenic than others, and that APOE measurement may provide information on risk of CAD above traditional risk factor measurement. It has also been proposed that the APOE genotype may be useful in the selection of specific components of lipid-lowering therapy, such as drug selection. In the major lipid-lowering intervention trials, including trials of statin therapy, there is considerable variability in response to therapy that cannot be explained by factors such as compliance. APOE genotype may be 1 factor that determines an individual’s degree of response to interventions such as statin therapy.

POSITION STATEMENT:

Measurement of Apolipoprotein B (apo B) or Apolipoprotein E (apo E) genotype or phenotype is considered experimental or investigational for all indictions including as an adjunct to LDL cholesterol in the risk assessment and management of cardiovascular disease. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code to report the measurement of apo B or apo E genotype/phenotype.

REIMBURSEMENT INFORMATION:

None applicable.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) or Local Coverage Determination (LCD) was found at the time of the last guideline reviewed date.

DEFINITIONS:

None

NoneRELATED GUIDELINES:

Tumor/Genetic Markers, 05-86000-22

OTHER:

None applicable.

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference Manual,2.04.65 Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease, 12/16.
  2. ClinicalTrials.gov, The Association of SAA With Apolipoprotein B Affects Cardiovascular Risk, sponsored by Lisa Tannock.
  3. ClinicalTrials.gov, Hypertriglyceridaemia: Therapeutic Targets, Genetic Causes, and Associated Neuropathy, sponsored by Central Manchester University Hospitals NHS Foundation Trust.
  4. ClinicalTrials.gov, A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers, sponsored by Preventive Medicine Research Institute, accessed 12/27/10.
  5. Ferreira CN, et al, Comparative Study of Apolipoprotein-E Polymorphism and Plasma Lipid Levels in dyslipidemic and Asymptomatic Subjects, and Their Implication in Cardio/Cerebrovascular Disorders, Neurochem Int. Epub Oct 2009.
  6. Huang Y, Mechanisms Linking Apolipoprotein E Isoforms with Cardiovascular and Neurological Diseases, Curr Opin Lipidol. 2010 Aug; 21(4): 337-45.
  7. Liu, S., Ma J., Ridker, PM., Breslow, JL., Stampfer, MJ. A Prospective study of the Association Between APOE Genotype and the Risk of Myocardial Infarction Among Apparently Healthy Men. Atherosclerosis, 02/03.
  8. National Institute for Health and Care Excellence (NICE). Cardiovascular disease: risk assessment and reduction, including lipid modification [CG181]. 2016.
  9. Paternoster L, Gonzalez NA, Lewis S, Sudlow C, Association Between Apolipoprotein E Genotype and Carotid Intima-Media Thickness May Suggest a Specific Effect on Large Artery Atherothrombotic Stroke, Stroke. 2008 Jan; 39(1): 48-54, 12/07.
  10. Piepoli MF, Hoes AW, Agewall S, et al. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. Aug 1 2016;37(29):2315-2381.
  11. Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), 2004, accessed at nhlbi.nih.gov 12/27/10.
  12. Ward, H, et al, APOE Genotype, Lipids, and Coronary Heart Disease Risk, Arch Intern Med. 2009; 169 (15): 1424-1429.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/25/17.

GUIDELINE UPDATE INFORMATION:

02/15/02

New Medical Coverage Guideline.

03/15/03

MCG annual review.

04/15/04

MCG annual review; maintain investigational status.

04/15/05

Scheduled review, no change in coverage statement. Revised billing coding information section; added code 82172. Updated references.

03/15/06

Annual review; continue investigational status.

03/15/07

Scheduled review; no change in coverage statement; references updated.

06/15/07

Reformatted guideline.

03/15/08

Annual review: position statement maintained and references updated.

03/15/09

Annual review: position statement maintained and references updated.

03/15/10

Annual review: position statement maintained and references updated.

02/15/11

Annual review: position statement maintained, and references updated.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

06/15/17

Revision; Investigational position maintainted; guideline title, description, position statement, and references updated.

Date Printed: August 23, 2017: 05:46 AM