Subject:
Measurement of Long-Chain Omega-3 Fatty Acids in Red Blood Cell Membranes as a Cardiac Risk Factor
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Epidemiologic studies have reported that subjects who eat a diet high in fish have a reduced risk of sudden cardiac death. Fish are rich in long-chain omega-3 fatty acids, and it has been hypothesized that these fatty acids may be responsible for the beneficial effect. Long-chain omega-3 fatty acids may be detected in the red cell membrane using gas chromatography. It has been suggested this measurement may be clinically useful as a cardiac risk factor for sudden cardiac death.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Measurement of long-chain omega-3 fatty acids in red blood cell membranes, including but not limited to its use as a cardiac risk factor, is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: A search of the literature identified many observational studies exploring the relationship between fish consumption and coronary heart disease mortality in different populations of patients. These studies suggest that mortality from coronary heart disease may be reduced by including fish as a regular part of the diet. However, the search did not identify any published articles that explored how the measurement of red blood cell membrane omega-3 fatty acids may be used to improve patient management. For example, studies establishing the diagnostic parameters of omega-3 fatty acids, i.e., the definition normal, high, and low values were not identified. It has been suggested that measurement of omega-3 fatty acids may be incorporated into a cardiac risk panel in patients with a prior cardiac event. No studies focused on this application of this laboratory test. In addition, improved risk prediction does not by itself result in better health outcomes. To improve outcomes, clinicians must have the tools to translate this information into clinical practice. At the present time, patients with coronary artery disease are offered the general dietary recommendation to increase fish consumption, a recommendation not based on red blood cell membrane levels of omega-3 fatty acids.
Update
Several clinical trials were located on ClinicalTrials.gov. At this time (May, 2018) NCT03159507 Effect of Omega-3 Index on Cellular Metabolism and Quality of Life is recruiting participants. NCT01089231 Effects of Omega-3 Fatty Acids on the Human Gene Expression concluded "Further studies combining genetic and metabolic endpoints are needed to verify the regulative effects of n-3 PUFAs in antioxidative gene expression to better understand their beneficial effects in health and disease prevention."
The Japan Eicosapentaenoic Acid Lipid Intervention Study (JELIS) trial compared fish oil capsules plus statins to statins alone in 18,645 patients with hypercholesterolemia. In this primary and secondary prevention study, if hypercholesterolemia remained uncontrolled, the dose of the statin could be raised by protocol. No measurements of the efficacy of fish oil treatment were performed and the dose remained constant throughout the study. The fish oil plus statin group had 18% (p=0.132) and 19% (p=0.015) fewer non-fatal (primary and secondary, respectively) cardiac events over a mean of 4.6 years compared to the statin only group.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Measurement of Long-Chain Omega-3 Fatty Acids in Red Blood Cell Membranes as a Cardiac Risk Factor
Long-Chain Omega-3 Fatty Acids, Measurement oOmega-3 Fatty Acids, Measurement of
References:
1. He K Song Y, Daviglus ML et al. Accumulated evidence of fish consumption and coronary heart disease mortality: a meta-analysis of cohort studies. Circulation 2004; 109(22):2705-11.
2. Hu FB, Cho E, Rexrode KM et al. Fish and long-chain omega-3 fatty acid intake and risk of coronary heart disease and total mortality in diabetic women. Circulation 2003; 107(14):1852-7.
3. He K, Song Y, Daviglus ML et al. Fish consumption and incidence of stroke: a meta-analysis of cohort studies. Stroke 2004; 35(7):1538-42.
4. Whelton SP, He J, Whelton PK et al. Meta-analysis of observational studies on fish intake and coronary heart disease. Am J Cardiol 2004; 93(9):1119-23.
5. Mozaffarian D, Longstreth WT, Lemaitre RN et al. Fish consumption and stroke risk in elderly individuals: the cardiovascular health study. Arch Intern Med 2005; 165(2):200-6.
6. Albert CM, Campos H, Stampfer MJ et al. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N Engl J Med 2002; 346(15):1113-8.
7. Balk E, Chung M, Lichtenstein A et al. Effects of Omega-3 Fatty Acids on Cardiovascular Risk Factors and Intermediate Markers of Cardiovascular Disease. Evidence Report/Technology Assessment no. 93 (Prepared by Tufts-New England Medical Center Evidence-based Practice Center under Contract no. 290-02-0022). AHRQ Publication No. 04-E010-2. Rockville, MD: Agency for Healthcare Research and Quality. March 2004. [Available at: http://www.ahrq.gov/clinic/epcsums/o3cardrisksum.pdf.]
8. American Heart Association (AHA) Recommendation: Fish and Omega-3 Fatty Acids. Available at: http://www.heart.org/HEARTORG/GettingHealthy/NutritionCenter/HealthyDietGoals/Fish-and-Omega-3-Fatty-Acids_UCM_303248_Article.jsp Updated: June 15, 2015.
9. Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet 2007;369(9567):1090-8.
10. Greenland P, Alpert JS, Beller GA, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation 2010 Dec;21;122(25):e584-636.
11. UpToDate. Overview of the risk equivalents and established risk factors for cardiovascular disease. Literature review current through July 2016. Topic last updated April 14, 2016.
12. Wilson PWF. Overview of the risk equivalents and established risk factors for cardiovascular disease. In: UpToDate, Cannon CP, Downey BC (Eds), UpToDate, Waltham, MA. (Accessed June 9, 2017.)
13. Roke K, Walton K, Klingel SL, Harnett A, Subedi S, Haines J, Mutch DM. Evaluating Changes in Omega-3 Fatty Acid Intake after Receiving Personal FADS1 Genetic Information: A Randomized Nutrigenetic Intervention. Nutrients. 2017 Mar 6;9(3). pii: E240. doi: 10.3390/nu9030240.
14. Schmidt S, Stahl F, Mutz KO, Scheper T, Hahn A, Schuchardt JP. Transcriptome-based identification of antioxidative gene expression after fish oil supplementation in normo- and dyslipidemic men. Nutr Metab (Lond). 2012 May 23;9(1):45. doi: 10.1186/1743-7075-9-45.
Codes:
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