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Medical Policy: 02.04.03
Original Effective Date: July 2002
Reviewed: August 2011
Revised: August 2011
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
C-reactive protein (CRP) is produced by the liver during the acute inflammatory phase of an illness. It has long been used as a diagnostic test for conditions such as infections and autoimmune diseases. Recent studies have suggested that low level chronic inflammation may play a role in atherogenesis, and thus measurement of CRP has been investigated for risk assessment in primary prevention of cardiovascular diseases. High sensitivity CRP (hsCRP) assays are necessary for such studies. While a regular CRP test is adequate for evaluation of a clinically significant inflammatory process, it lacks the sensitivity needed for risk assessment of cardiovascular diseases.
Numerous studies have evaluated the predictive ability of hs-CRP in various clinical situations including as an independent predictor of future cardiac events for patients with acute myocardial infarction (MI), following stenting with drug-eluting stents, post-coronary artery bypass graft (CABG) surgery, and following vascular surgery.
There are fewer studies that examine the impact of hs-CRP on management, the most prominent of which is the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial. JUPITER was a multicenter randomized controlled trial that enrolled 17,802 individuals (men age 50 years or older and women age 60 years or older) from more than 1300 sites in 26 countries and evaluated the efficacy of statin therapy in those selected for elevated CRP and normal LDL levels. The main eligibility criteria included an elevated CRP (greater than 2.0 mg/dL), “normal” LDL (less than 130 mg/dL), and no previous history of heart disease or diabetes mellitus. Patients were randomly assigned to treatment with rosuvastatin or placebo, and follow-up was planned for 4 years. The primary outcome measure was a composite of cardiovascular death, MI, stroke, UA, and revascularization. A second composite outcome was also reported for hard events, i.e., cardiovascular death, MI, and stroke. The trial was stopped early at 1.9 years due to interim analysis that showed benefit in the statin group.
This study establishes that patients with high CRP and normal LDL levels benefit from treatment with statins. However, interpretation of the JUPITER trial remains controversial and there is some debate around several issues including whether the absolute risk of cardiac disease for this population is high enough to warrant treatments with statins; whether selecting patients primarily with CRP level is the optimal method for risk stratification and selection for statin treatment; and whether the relatively large relative risk reduction reported in this trial is due to selection of patients based on high CRP levels.
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Prior Approval:
Not applicable
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Policy:
High-sensitivity C-reactive protein testing may be considered medically necessary for individuals who meet all of the following criteria:
- Two or more coronary heart disease (CHD) major risk factors*
- LDL cholesterol levels between 100 and 130 mg/dL
- Judged to be at an intermediate risk of cardiovascular disease by a global risk assessment (i.e., 10 to 20% risk of CHD per 10 years using Framingham point scoring)
*Major risk factors include:
- Age (men aged 45 years or older; women aged 55 years and older)
- Current cigarette smoking
- Family history of premature CHD (CHD in male first degree relative less than 55 years of age; CHD in female first degree relative less than 65 years of age)
- Hypertension (BP 140 mmHg or higher, or on antihypertensive medication)
- Low HDL cholesterol (less than 40 mg/dL)
High-sensitivity C-reactive protein testing is considered investigational for all other indications including:
- as a screening test for the general population
- as a risk assessment in asymptomatic high-risk adults
- as a risk assessment in low-risk men younger than 50 years of age or women younger than 60 years of age
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifies, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9 diagnostic codes.
- 86141 C-reactive protein; high sensitivity (hsCRP)
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Selected References:
- Bogaty P, Brophy JM, et al. Fluctuating inflammatory markers in patients with stable ischemic heart disease. Arch Intern med. 2005;165(2):221-6.
- Kushner I, Sehgal, AR. Is high-sensitivity c-reactive protein an effective screening test for cardiovascular risk? Archives of Internal Medicine 2002; 162:867-869.
- Ledue TB, Rifal N. High sensitivity immunoassays for c-reactive protein: promises and pitfalls. Clinical Chemistry and Laboratory Medicine 2001; 39(11):1171-1176.
- Cheillot O, Henny J, Steinmetz J, Herbeth B, Wagner C and Siest G. High sensitivity C-reactive protein: Biological variations and reference limits. Clinical Chemistry and Laboratory Medicine 2002; 38(10):1003-1011.
- Legrays VA. The use of high sensitivity c-reactive protein in assessing the risk for coronary heart disease. Clinical Laboratory Science 2001; 14(4):243-246.
- Ridker PM. High sensitivity c-reactive protein. Potential adjunct for global risk assessment in the primary prevention of cardiovascular disease. Circulation 2001; 103:1813-1818.
- Pearson TA. New tools for coronary risk assessment. What are their advantages and limitations? Circulation 2002; 105:886-892.
- Arteriosclerosis. In MH Beers & R Berkow (Eds.), Merck Manual of Diagnosis and Therapy, 17th ed. (1999), chapter 201, pp. 1654-8.
- Pearson TA, Mensah GA, et al. Markers of inflammation and cardiovascular disease: application to clinical and public health practice: A statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association. Circulation. 2003 Jan 28;107(3):499-511.
- Danesh J, Wheeler JG, et al. C-reactive protein and other circulating markers of inflammation in the prediction of coronary heart disease. N Engl J Med. 2004 Apr 1;350(14):1387-97.
- Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, Witztum JL. Lipoprotein management in patients with cardiometabolic risk: consensus conference report from the American Diabetes Association and the American College of Cardiology Foundation. J Am Coll Cardiol 2008 Apr 15;51(15):1512-24.
- Yang EY, Nambi V, Tang Z et al. Clinical implications of JUPITER (Justification for the Use of statin in Preventions: an Intervention Trial Evaluating Rosuvastatin) in a U.S. population: insights from the ARIC (Atherosclerosis Risk In Communities) study. J Am Coll Cardiol 2009; 54(25):2388-95.
- Abd TT, Eapen DJ, Bajpai A et al. The role of C-reactive protein as a risk predictor of coronary atherosclerosis: implications from the JUPITER trial. Curr Atheroscler Rep 2011; 13(2):154-61.
- Lim LS, Haq N, Mahmood S et al. Atherosclerotic cardiovascular disease screening in adults: American College of Preventive Medicaine position statement on preventive practice. Am J Prev Med 2011; 40(3):381 e1-10.
- Buckley DI, Fu R, Freeman M et al. C-reactive protein as a risk factor for coronary heart disease: a systematic review and meta-analyses for the U.S. Preventive Services task Force. Ann Intern Med 2009; 151(7):483-95.
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Policy History:
Date Reason Action
September 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
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practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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