mp-245 - Medical Policies - Alabama
Ultrasonographic Measurement of Carotid Intimal-Medial Thickness as an Assessment of Subclinical Atherosclerosis
Policy Number: MP-245
Latest Review Date: May 2020
Policy Grade: C
Ultrasonographic measurement of carotid artery intimal-medial thickness (CIMT) as a technique for identifying subclinical atherosclerosis for use in the screening, diagnosis, or management of atherosclerosis is considered not medically necessary and investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Ultrasonographic measurement of carotid intima-medial (or intimal-media) thickness (CIMT) refers to the use of B-mode ultrasound to determine the thickness of the two innermost layers of the carotid artery wall, the intima and the media. Detection and monitoring of intima-medial thickening, which is a surrogate marker for atherosclerosis, may provide an opportunity to intervene earlier in atherogenic disease and/or monitor disease progression.
Coronary Heart Disease
Coronary heart disease (CHD) accounts for 30.8% of all deaths in the United States. Established 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.
The third report of the NCEP Adult Treatment Panel (ATP III) establishes various treatment strategies to modify the risk of CHD, with emphasis on target goals of LDL cholesterol. Pathology studies have demonstrated that levels of traditional risk factors are associated with the extent and severity of atherosclerosis. ATP III recommended the use of the Framingham criteria to further stratify those patients with two or more risk factors for more intensive lipid management. However, at every level of risk factor exposure, there is substantial variation in the amount of atherosclerosis, presumably related to genetic susceptibility and the influence of other risk factors. Therefore, there has been interest in identifying a technique that can improve the ability to diagnose those at risk of developing CHD, as well as measure disease progression, particularly for those at intermediate risk.
The carotid arteries can be well visualized by ultrasonography, and ultrasonographic measurements of the thickness of the carotid intimal-medial wall (CIMT) has been investigated as a technique to identify and monitor subclinical atherosclerosis. B-mode ultrasound is most commonly used, and the intimal-medial thickness 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.
The most recent literature review was performed through March 9, 2020.
Summary of Evidence
For individuals who are undergoing cardiac risk assessment who receive ultrasonic measurement of carotid intima-media thickness, the evidence includes a randomized controlled study, large cohort studies, case control studies, and systematic reviews. Relevant outcomes are test accuracy and morbid events. Some studies correlate increased carotid intima-medial thickness (CIMT) with many other commonly used markers for risk of coronary heart disease (CHD) and with risk for future cardiovascular events. A 2012 meta-analysis of individual participant data by Lorenz et al found that CIMT was associated with increased cardiovascular events, CIMT progression over time was not associated with increased cardiovascular event risk. In a systematic review by Peters et al (2012), the added predictive value of CIMT was modest, and the ability to reclassify patients into clinically relevant categories was not demonstrated. The results from these studies and others demonstrate the predictive value of CIMT is uncertain, and the predictive ability for any level of population risk cannot be determined with precision. In addition, available studies do not define how the use of CIMT in clinical practice improves outcomes. 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 objective of one study, however, was to define “normal” CIMT progression in low to moderate cardiovascular risk patients. Study results showed definite patterns related to various factors that could be used as a tool to earlier identify patients at increased cardiovascular risk, but patient outcomes were not assessed. The evidence is insufficient to determine the effects of this technology on net health outcome.
Practice Guidelines and Position Statements
American College of Cardiology and American Heart Association
A 2013 guideline on the assessment of cardiovascular risk from the American College of Cardiology and the American Heart Association (ACC/AHA) does not recommend CIMT for routine risk assessment of a first atherosclerotic cardiovascular disease event. (ACC/AHA Class III: no benefit, LOE: B). This differs from the previous 2010 version of the ACC/AHA guidelines for assessment of cardiovascular risk, which indicated CIMT might be reasonable for assessing cardiovascular risk in intermediate risk asymptomatic adults.
American Association of Clinical Endocrinologists et al
The American Association of Clinical Endocrinologists and American College of Endocrinology published 2017 guidelines stating that CIMT could be applied as a risk stratification tool in determining the need for more aggressive preventive strategies against cardiovascular disease (Grade B; BEL 2)—but that it should not be performed routinely.
American Society of Echocardiography
The 2008 American Society of Echocardiography Consensus Statement endorsed by the Society for Vascular Medicine, states that CIMT is a feature of arterial wall aging “that is not synonymous with atherosclerosis, particularly in the absence of plaque.” The statement recommends measurement of both CIMT and carotid plaque by ultrasound “for refining CVD risk assessment in patients at intermediate cardiovascular disease risk (Framingham Risk Score 6–20%) without established CHD, peripheral arterial disease, cerebrovascular disease, diabetes mellitus, or abdominal aortic aneurysm.” However, the authors acknowledge that, “More research is needed to determine whether improved risk prediction observed with CIMT or carotid plaque imaging translates into improved patient outcomes.”
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force (2009; USPSTF) published a systematic review of CIMT within the scope of a larger recommendation on the use of nontraditional risk factors in coronary heart disease risk assessment. USPSTF could not draw conclusions on the applicability of CIMT to the intermediate-risk population at large outside the research setting. The USPSTF summary of recommendation specific to CIMT stated that: “… the current evidence is insufficient to assess the balance of benefits and harms of using … [CIMT] … to screen asymptomatic men and women with no history of CHD to prevent CHD events.” USPSTF identified the following research need: “The predictive value … of carotid IMT … should be examined in conjunction with traditional Framingham risk factors for predicting CHD events and death.”
In 2018, the USPSTF published a recommendation statement on using nontraditional risk factors to assess risk of cardiovascular disease; CIMT was not mentioned in this recommendation.
Carotid intimal medial thickness (CIMT), B-mode ultrasound, intimal medial thickness, IMT, atherosclerosis, ultrasonographic measurement, SonoCalc®, Cardioscan
APPROVED BY GOVERNING BODIES:
In February 2003, SonoCalc® (SonoMetric Health, LLC, Bountiful UT) was cleared for marketing by the 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 intima media thickness of the carotid artery from images obtained from ultrasound systems. Subsequently, several other devices have been approved through the 510(k) process.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral
Carotid intima media thickness
It is possible that providers may incorrectly use the following CPT code:
Duplex scan of extracranial arteries; complete bilateral study
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- Blue Cross Blue Shield Association. Ultrasonographic measurement of carotid intimal-medial thickness as an assessment of subclinical atherosclerosis. Medical Policy Reference Manual, July 2010.
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Medical Policy Group, August 2005 (3)
Medical Policy Administration Committee, August 2005
Available for comment August 27-October 10, 2005
Medical Policy Group, August 2006 (1)
Medical Policy Group, August 2007(1)
Medical Policy Group, March 2009 (4)
Medical Policy Group, July 2009 (3)
Medical Policy Group, July 2010 (1): Policy updated, no coverage change
Medical Policy Group, July 2011 (1): Update to Description, Key Points and References
Medical Policy Group, July 2012 (1): Update to Key Points and References related to MPP update; no change to policy statement
Medical Policy Group, July 2013 (4): 2013 Update to Key Points and References related to Diagnostic Utility
Medical Policy Panel, July 2014
Medical Policy Group, July 2014 (4): Updated Key Points, Practice Guidelines and References. No change to policy statement at this time.
Medical Policy Group, November 2014: 2015 Annual Coding update. Added code 93895 to current coding
Medical Policy Panel, July 2015
Medical Policy Group, July 2015 (4): Updates to Description, Key Points, Key Words, Coding, and References. No change to policy statement. Moved CPT 93799 to previous coding section
Medical Policy Group, January 2016 (4): Added CPT code 93880 to Coding section.
Medical Policy Group, April 2016 (4): Added the statement “It is possible that providers may incorrectly use the following CPT code”.
Medical Policy Panel, January 2017
Medical Policy Group, January 2017(4): Updates to Description, Key Points, and References. No change to policy statement.
Medical Policy Group, October 2017 (4): Added Key Word Cardioscan.
Medical Policy Panel, May 2018
Medical Policy Group, May 2018 (4): Updates to Description, Key Points, and References. No change to policy statement.
Medical Policy Panel, May 2019
Medical Policy Group, May 2019 (4): Updates to Description, Key Points, and Coding. Removed Previous coding section with code 93799.
Medical Policy Panel, May 2020
Medical Policy Group, May 2020 (4): Updates to Key Points and References. No change to policy statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.