Medical Policy: 02.02.14
Original Effective Date: June 2012
Reviewed: January 2016
Revised: February 2014
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.
Coronary heart disease (CHD) accounts for 27% of all deaths in the United States. Major risk factors for CHD have been identified by the National Cholesterol Education Program (NCEP) Expert Panel. These risk factors include elevated serum levels of low-density lipoprotein (LDL) cholesterol, total cholesterol, and reduced levels of high-density lipoprotein (HDL) cholesterol. Other risk factors include a history of cigarette smoking, hypertension, family history of premature CHD, and age.
Measurement of the carotid intima-media thickness (CIMT) is a non-invasive test where the lining of the carotid arteries is measured with the use of B-mode ultrasound. The intima is the innermost layer of the artery and the media is the middle layer of the artery. The intima-media thickness is measured for the objective of detecting preclinical or subclinical cardiovascular disease. Measurement of the CIMT is considered to be a surrogate marker for the measurement of atherosclerosis, which correlates with the presence of coronary atherosclerosis. This has led to the theory that it may represent an independent marker, separate from the traditional risk factors for cardiovascular disease and stroke.
The intima-media thickness (IMT) is measured and averaged over several sites in each carotid artery. Imaging of the far wall of each common carotid artery yields more accurate and reproducible IMT measurements than imaging of the near wall. Two echogenic lines are produced, representing the lumen- intima interface and the media-adventitia interface. The distance between these two lines constitutes the IMT.
At this time, there is a lack of standardization of measurement and imaging protocols. It is not clear whether generalized IMT or focal plaque formation is of more importance. The literature also indicates that there are gender and age related differences with IMT. A definition of what is considered expected normal limits that take into account these differences has not been established. It is not evident from the literature that CIMT is able to improve on risk prediction above what is provided by utilization of traditional risk factors or the effect of these measurements on patient outcomes.
Practice Guidelines and Position Statements
U.S. Preventative Services Task Force (USPSTF)
In October 2009, the U.S. Preventative Services Task Force (USPSTF) published a systemic review of CIMT within the scope of a larger recommendation statement entitled “Coronary Heart Disease: Screening Using Non-Traditional Risk Factors”. Coronary heart disease is the most common cause of mortality in adults in the United States. Treatment to prevent CHD events by modifying risk factors is currently based on the Framingham risk model, which sorts individuals into low, intermediate or high risk groups. If the risk model could be improved, treatment might be better targeted, thereby maximizing screening benefits and minimizing harms. The most likely opportunity to improve the model is use of additional risk factors to reclassify those in the intermediate risk group to either high or low risk.
Summary of Recommendation
The U.S. Preventative Services Task Force (USPSTF) concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the nontraditional risk factors discussed in this statement to screen asymptomatic men and women with no history of CAD to prevent CHD events.
The nontraditional risk factors include in this recommendation are high sensitivity C reactive protein (hs-CRP), ankle brachial index (ABI), leukocyte count, fasting blood glucose level, periodontal disease, carotid intima-media thickness (carotid IMT), coronary artery calcification (CAC) score on electron beam computed tomography (EBCT), homocystein level and lipoprotein(a) level.
American College of Cardiology Foundation/American Heart Association
2010 Practice Guidelines, Assessment of Cardiovascular Risk in Asymptomatic Adults
The guidelines indicate the measurement of carotid artery IMT is reasonable for assessment of cardiovascular risk assessment in asymptomatic adults at intermediate risk. The guidelines note an increased CIMT reading may be used as a guide in determining clinical utility, but evidence has not demonstrated improvements in outcomes when incorporating CIMT measurement into treatment decision making. Additionally, the guidelines state “clinical tools integrating carotid IMT within global risk scoring system are not available. The incremental value of carotid IMT and cost effectiveness beyond that available from standard risk assessments to improve overall patient outcomes is not established.”
2013 American College of Cardiology/American Heart Association Guideline on the Assessment of Cardiovascular Risk
Carotid IMT is not recommended for routine measurement in clinical practice for risk assessment for first atherosclerotic cardiovascular disease (ASCVD) event.
In February 2003, SonoCalc® (SonoSite) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this software was substantially equivalent to existing image display products for use in the automatic measurement of the IMT of the carotid artery from images obtained from ultrasound systems. Subsequently, several other devices have been approved through the 510(k) process.
Ultrasonographic measurement of carotid artery intima-media thickness (CIMT) as a technique of identifying subclinical atherosclerosis is considered investigational for use in the screening, diagnosis, or management of atherosclerotic disease.
Based on peer reviewed medical literature the available studies do not define how the use of CIMT in clinical practice improves outcomes. Also, there is no scientific literature that directly tests the hypothesis that measurement of CIMT results in improved patient outcomes and no specific guidance on how measurements of CIMT should be incorporated into risk assessment and risk management. The existing evidence is insufficient to determine the impact of this technology on net health outcomes. Therefore, carotid intima-media thickness (CIMT) is considered investigational for the use in the screening, diagnosis or management of atherosclerotic disease.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 0126T Common carotid intima-media thickness (IMT) study for evaluation of atherosclerotic burden or coronary heart disease risk factor assessment.
- 93895 Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral
- Lorenz MW, Polak JF, Kavousi M et al. Carotid intima-media thickness progression to predict cardiovascular events in the general population (the PROG-IMT collaborative project): a meta-analysis of individual participant data. Lancet. 2012 Jun 2; 379(9831):2053-62. Epub 2012 Apr27.
- Peters SA, den Ruijter HM, Bots ML et al. Improvements in risk stratification for the occurrence of cardiovascular disease by imaging subclinical atherosclerosis: a systematic review. Heart 2012; 98(3):177-84.
- Roger VL, Go AS, Lloyd-Jones DM et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2012 update: a report from the American Heart Association. Circulation. 2012; 125:e2-e220.
- Johnson HM, Turke TL, Grossklaus M et al. Effects of an office-based carotid ultrasound screening intervention. J AM Soc Echocardiogr 2011; 24(7):738-47.
- Ikeda K, Takahashi T, Yamada H et al. Effect of intenstive statin therapy on regression of carotid intima-media thickness in patients with subclinical atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study. Eur J Prev Cardiol. 2012 Jun 11. [Epub ahead of print].
- Polak JF, Pencina MJ, O’Leary DH et al. Common carotid artery intima-media thickness progression as a predictor of stroke in multi-ethnic study of atherosclerosis. Stroke. 2011 Nov; 42(11):2017-21. Epub 2011 Sep 1.
- Bis JC, Kavousi M, Franceschini N et al. Meta-analysis of genome-wide association studies for the CHARGE consortium identifies common variants associated with carotid intima media thickness and plaque. Nat genet. 2011 Sep 11; 43(10): 940-7. doi: 10.1038/ng.920.
- Polak JF, Pencina MJ, Pencina KM et al. Carotid-wall intima-media thickness and cardiovascular events. N Engl J Med. 2011 Jul 21; 365(3):213-21.
- Plichart M, Celermajer DS, Zureik M et al. Carotid intima-media thickness in plaque-free site, carotid plaques and coronary heart disease risk prediction in older adults. The Three-City Study. Atherosclerosis 2011; 219(2):917-24.
- Keo HH, Baumgartner I, Hirsch AT et al. Carotid plaque and intima-media thickness and the incidence of ischemic events in patients with atherosclerotic vascular disease. Vasc Med 2011; 16(5):323-30.
- Nambi V, Chambless L, He M et al. Common carotid artery intima-media thickness is as good as carotid intima-media thickness of all carotid artery segments in improving prediction of coronary heart disease risk in the Atherosclerosis Risk Communities (ARIC) study. Eur Heart J 2012; 33(2):183-90.
- Xie W, Liang L, Zhao L et al. Combination of carotid intima-media thickness and plaque for better predicting risk of ischaemic cardiovascular events. Heart 2011; 97(16):1326-31.
- Costanzo P, Perrone-Filardi P, Vassallo E et al. Does carotid intima-media thickness regression predict reduction of cardiovascular events? A meta-analysis of 41 randomized trials. J Am Coll Cardiol. 2010 Dec 7; 56(24):2006-20.
- Mookadam F, Moustafa SE, Lester SJ et al. Subclinical atherosclerosis: evolving role of carotid intima-media thickness. Prev Cardiol. 2010 Fall; 13(4):186-97. doi: 10.1111/j/1751-7141.2010.00072.x.
- ECRI, Carotid Intima-Media Thickness for Assessing Coronary Artery Disease Risk, June 2012
- U.S. Preventative Service Task ForceExternal Site, Using Nontraditional Risk Factors in Coronary Heart Disease Risk Assessment, Recommendation Statement, October 2009.
- 2010 ACCF/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults: Executive Summary, Philip Greenland, M.D., FACC, FAHA et al. Journal of the American College of Cardiology Vol. 56, No. 25, 2010
- American Heart Association. 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation, published online November 12, 2013
- Lim LS, et. al. Atherosclerotic Cardiovascular Disease Screening in Adults: American College of Preventative Medicine Position Statement on Preventative Practice, AM J Prev Med. 2011 Mar; 40(3):381.el-10.
- Hester M. Den Ruijter, PhD, Sanne A.E. Peters, MSc, et. al, Common Carotid Intima_Media Thickness Measurements in Cardiovascular Risk Prediction: A Meta-Analysis, JAMA 2012;308(8):796-803.doi:10.1001
- Micheil L. Bots M.D., Hester M. den Ruijter, PhD, Should We Indeed Measure Carotid Intima-Media Thickness for Improving Prediction of Cardiovascular Events After IMPROVE?.External Site Journal of American College of Cardiology 2012.
- UpToDate. Carotid Intima-Media Thickness, Eric de Groot, M.D., PhD, John JP Kastelein, M.D., PhD, FESC, Raphael Duivenvoorden, M.D., PhD. Topic last updated November 3, 2014.
- Baber U, Mehran R, Satori S, et. al. Prevalence, Impact, and Predictive Value of Detecting Subclinical Coronary and Carotid Atherosclerosis in Asymptomatic Adults: The BioImage Study. J Am Coll Cardiol. Mar 24 2015;65(11):1065-1074
- Steinl D and Kaufman B, Ultrasound Imaging for Risk Assessment in Atherosclerosis. Int J Mol Sci 2015 May, 16(5):9749-9769
January 2016 - Annual Review, Policy Renewed
January 2015 - Annual Review, Policy Renewed
February 2014 - Annual Review, Policy Revised
May 2013 - Annual Review, Policy Renewed
June 2012 - New Policy
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
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
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 © 2012 American Medical Association. All Rights Reserved.