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Computed Tomography to Detect Coronary Artery Calcification

Policy Number: MP-646

Effective for dates of service on or after  September 12, 2020, refer to: PET, MRI, MRA, CT, CTA/CCTA (Advanced Imaging Guidelines)

Latest Review Date: August 2020

Category:  Radiology

Policy Grade: C

POLICY:

Effective for dates of service on or after  September 12, 2020, refer to:

PET, MRI, MRA, CT, CTA/CCTA (Advanced Imaging Guidelines)

Effective for dates of service prior to  September 12, 2020:

Computed tomography, heart, without contrast material including image post-processing and quantitative evaluation of coronary calcium may be considered medically necessary when a CCT or CCTA meets the coverage criteria, but when a review of the initial non-contrast CT images is reviewed it is determined that based on the calcium volume the patient is not a candidate for the arterial phase component of the study. (In this case only code 75571 should be reported.)

The use of computed tomography to detect coronary artery calcification as a stand-alone test is considered not medically necessary and investigational

DESCRIPTION OF PROCEDURE OR SERVICE:

Several types of fast computed tomography (CT) imaging, including electron beam computed tomography and spiral CT, allow the quantification of calcium in coronary arteries. Coronary artery calcium (CAC) is associated with coronary artery disease (CAD). The use of CAC scores has been studied in the prediction of future risk of CAD and in the diagnosis of CAD in symptomatic patients.

Coronary Artery Calcium

Coronary artery calcium (CAC) is associated with coronary artery disease (CAD) based on anatomic studies. The development of fast computed tomography (CT) scanners has allowed the measurement of CAC in clinical practice. CAC has been evaluated in several clinical settings. The most widely studied indication is for the use of CAC in the prediction of future risk for CAD in patients with subclinical disease, with the goal of instituting appropriate risk-reducing therapy (e.g., statin treatment, lifestyle modifications) to improve outcomes. In addition, CAC has been evaluated in patients with symptoms potentially consistent with CAD, but in whom a diagnosis is unclear.

Detection

Electron beam computed tomography (EBCT; also known as ultrafast CT) and spiral CT (or helical CT) may be used as an alternative to conventional CT scanning due to faster throughput. Their speed of image acquisition gives them unique value for imaging a moving heart. The rapid image acquisition time virtually eliminates motion artifact related to cardiac contraction, permitting visualization of the calcium in the epicardial coronary arteries. EBCT software permits quantification of calcium area and density, which are translated into calcium scores. Calcium scores have been investigated as a technique for detecting CAC, both as a diagnostic technique in symptomatic patients to rule out an atherosclerotic etiology of symptoms or, in asymptomatic patients, as an adjunctive method for risk stratification for CAD.

EBCT and multidetector computed tomography (MDCT) were initially the primary fast CT methods for measurement of CAC. A fast CT study for CAC measurement generally takes 10 to 15 minutes and requires only a few seconds of scanning time. More recently, computed tomography angiography (CTA) has been used to assess coronary calcium. Because of the basic similarity between EBCT and CTA in measuring coronary calcium, it is expected that CTA provides information on coronary calcium that is similar to EBCT.

CT scan‒derived coronary calcium measures have been used to evaluate coronary atherosclerosis. Coronary calcium is present in coronary atherosclerosis, but the atherosclerosis detected may or may not be causing ischemia or symptoms. Coronary calcium measures may be correlated with the presence of critical coronary stenosis or serve as a measure of the patient’s proclivity toward atherosclerosis and future coronary disease. Thus, it could serve as a variable to be used in a risk assessment calculation to determine appropriate preventive treatment in asymptomatic patients. Alternatively, in other clinical scenarios, it might help determine whether there is an atherosclerotic etiology or component to the presenting clinical problem in symptomatic patients, thus helping to direct further workup for the clinical problem. In this second scenario, a calcium score of 0 usually indicates that the patient’s clinical problem is unlikely to be due to atherosclerosis and that other etiologies should be more strongly considered. In neither case does the test actually determine a specific diagnosis. Most clinical studies have examined the use of coronary calcium for its potential use in estimating the risk of future coronary heart disease events.

Nomenclature

Coronary calcium levels can be expressed in many ways. The most common method is the Agatston score, which is a weighted summed total of calcified coronary artery area observed on CT. This value can be expressed as an absolute number, commonly ranging from 0 to 400. These values can be translated into age- and sex-specific percentile values. Different imaging methods and protocols will produce different values based on the specific algorithm used to create the score, but the correlation between any two methods appears to be high, and scores from one method can be translated into scores from a different method.

KEY POINTS:

The most recent literature review covers the period through July 29, 2019.

SUMMARY OF EVIDENCE

For individuals who are asymptomatic with the risk of CAD who receive CAC scoring, the evidence includes multiple systematic reviews, randomized controlled trials and, nonrandomized observational studies. The relevant outcomes are overall survival, test accuracy and validity, morbid events, and resource utilization. There is extensive evidence on the predictive value of CAC score screening for cardiovascular disease among asymptomatic patients, and this evidence has demonstrated that scanning has incremental predictive accuracy above traditional risk factor measurement. However, evidence from high-quality studies that has demonstrated that the use of CAC score measurement in clinical practice leads to changes in patient management or in individual risk behaviors that improve cardiac outcomes is lacking. A meta-analysis of RCTs reported no significant change in coronary risk profile, downstream testing or revascularization following screening using CAC scoring compared to no CAC scoring. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with signs and/or symptoms suggestive of CAD who receive CAC scoring before other diagnostic testing, the evidence includes prospective and retrospective nonrandomized studies. The relevant outcomes are overall survival, test accuracy and validity, morbid events, and resource utilization. CAC scoring has potential as a diagnostic test to rule out CAD in patients presenting with symptoms or as a “gatekeeper” test before invasive imaging is performed. Evidence from observational studies has suggested that negative results on CAC scoring rule out CAD with good reliability. However, the evidence has been inconsistent, with some studies reporting a lack of value of zero calcium score in ruling out CAD. Further prospective trials would be needed to demonstrate that such a strategy is effective in practice and is at least as effective as alternative strategies for ruling out CAD. To demonstrate that use of calcium scores improves the efficiency or accuracy of the diagnostic workup of symptomatic patients, rigorous studies that define exactly how CAC scores are used in combination with other tests in the triage of patients would be necessary. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American Heart Association/American College of Cardiology

The American Heart Association (AHA) and the American College of Cardiology (ACC) (2019) issued a special report on the use of risk assessment tools to guide decision-making in the primary prevention of atherosclerotic CVD. The guidelines include an algorithm of clinical approaches to incorporate CAC measurement in risk assessment for borderline- and intermediate-risk patients:

"For borderline-risk (10-year risk 5% to <7.5%) and intermedicate-risk (7.5% to < 20%) patients who are undecided regarding statin therapy, or when there is clinical uncertainty regarding the net benefit, consider the value of additional testing with measurement of CAC. If CAC is measured, interpret as follows:

  1. CAC score of ) indicated that a borderline- or intermediate-risk individual is reclassified to a 10-y event rate lower than predicted, and below the threshold for benefit from a statin. Consider avoiding or postponing statin therapy unless there is a strong family history of premature ADCVD, history of diabetes mellitus, or heavy cigarette smoking. Consider repeat CAC measurement in 5 years if patient remains at the borderline or intermediate risk.
  2. CAC score 1 to 99 and <75th percentile for age/sex/race/ethnicity indicates that there is subclinical atherosclerosis present. This may be sufficient information to consider initiating statin therapy, especially in younger individuals, but does not indicated substantial reclassification of the 10-y risk estimate. Consider patient preferences and, if statin decision is postponed, consider repeat CAC scoring in 5 years.
  3. CAC score 100 or >75th percentile for age/sex/race/ethnicity indicates that the individual is reclassified to a higher event rate than predicted, that is above the threshold for statin benefit. Statin therapy is more likely to provide benefit for such patients.

The American College of Cardiology/ and the American Heart Association (2018) Clinical Practice Guidelines on the Management of Blood Cholesterol state, "When risk status is uncertain, a CAC score is an option to facilitate decision making in adults ≥40 years of age." The guidelines further note, "One purpose of CAC scoring is to reclassify risk identification of patients who will potentially benefit from statin therapy. This is especially useful when the clinician and patient are uncertain whether to start a statin. Indeed, the most important recent observation has been the finding that a CAC score of zero indicates a low ASCVD risk for the subsequent 10 years. Thus, measurement of CAC potentially allows a clinician to withhold statin therapy in patients showing zero CAC."

National Institute for Health and Care Excellence

For patients with "stable chest pain who cannot be excluded by clinical assessment alone," the National Institute for Health and Care Excellence recommended CT using 64-sliceimaging. 

U.S. Preventive Services Task Force Recommendations

The U.S. Preventive Services Task Force (USPSTF) updated its recommendations on the use of nontraditional or novel risk factors in assessing coronary heart disease risk in asymptomatic persons.  Calcium score was one of three nontraditional risk factors considered. Reviewers concluded the current evidence was insufficient to assess the balance of benefits and harms of adding any of the nontraditional risk factors studied to assess the risk of coronary disease in asymptomatic persons.

KEY WORDS:

Computed tomography, coronary artery calcification, calcium score, calcium scoring

APPROVED BY GOVERNING BODIES:

Many models of computed tomography (CT) devices, including electron beam computed tomography (EBCT) and other ultrafast CT devices, have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: 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.

CURRENT CODING:

75571        Computed tomography, heart, without contrast material, with quantitative evaluation of coronary calcium

S8092        Electron beam computed tomography (also known as ultrafast CT, cine CT)

REFERENCES:

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  2. Bischoff B, Kantert C, Meyer T, et al. Cardiovascular risk assessment based on the quantification of coronary calcium in contrast-enhanced coronary computed tomography angiography. Eur Heart J Cardiovasc Imaging. Jun 2012; 13(6):468-475.
  3. Blaha MJ, Cainzos-Achirica M, Greenland P, et al. Role of coronary artery calcium score of zero and other negative risk markers for cardiovascular disease: the Multi-Ethnic Study of Atherosclerosis (MESA). Circulation. Mar 1 2016; 133(9):849-858.
  4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Diagnosis and screening for coronary artery disease with electron beam computed tomography. TEC Assessments. 1998; Volume 13: Tab 27.
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  21. Greenland P, LaBree L, Azen SP, et al. Coronary artery calcium score combined with Framingham score for risk prediction in asymptomatic individuals. Jama. Jan 14 2004; 291(2):210-215.
  22. Han D, Hartaigh BO, Gransar H, et al. Incremental prognostic value of coronary computed tomography angiography over coronary calcium scoring for major adverse cardiac events in elderly asymptomatic individuals. Eur Heart J Cardiovasc Imaging. Jun 1 2018; 19(6):675-683.
  23. Helfand M, Buckley DI, Freeman M, et al. Emerging risk factors for coronary heart disease: a summary of systematic reviews conducted for the U.S. Preventive Services Task Force. Ann Intern Med. Oct 6 2009; 151(7):496-507.
  24. Hou ZH, Lu B, Gao Y, et al. Prognostic value of coronary CT angiography and calcium score for major adverse cardiac events in outpatients. JACC Cardiovasc Imaging. Oct 2012; 5(10):990-999.
  25. Hulten E, Bittencourt MS, Ghoshhajra B, et al. Incremental prognostic value of coronary artery calcium score versus CT angiography among symptomatic patients without known coronary artery disease. Atherosclerosis. Mar 2014; 233(1):190-195.
  26. Johnson JE, Gulanick M, Penckofer S, et al. Does knowledge of coronary artery calcium affect cardiovascular risk perception, likelihood of taking action, and health-promoting behavior change? J Cardiovasc Nurs. Jan-Feb 2015; 30(1):15-25.
  27. Johnson JE, Gulanick M, Penckofer S, Kouba J. Does knowledge of coronary artery calcium affect cardiovascular risk perception, likelihood of taking action, and health-promoting behavior change? The Journal of cardiovascular nursing. Jan-Feb 2015; 30(1):15-25.
  28. Korley FK, George RT, Jaffe AS, et al. Low high-sensitivity troponin I and zero coronary artery calcium score identifies coronary CT angiography candidates in whom further testing could be avoided. Acad Radiol. Aug 2015; 22(8):1060-1067.
  29. Lakoski SG, Greenland P, Wong ND, et al. Coronary artery calcium scores and risk for cardiovascular events in women classified as "low risk" based on Framingham risk score: the multi-ethnic study of atherosclerosis (MESA). Arch Intern Med. Dec 10 2007; 167(22):2437-2442.
  30. LaMonte MJ, FitzGerald SJ, Church TS, et al. Coronary artery calcium score and coronary heart disease events in a large cohort of asymptomatic men and women. Am J Epidemiol. Sep 1 2005; 162(5):421-429.
  31. Laudon DA, Behrenbeck TR, Wood CM, et al. Computed tomographic coronary artery calcium assessment for evaluating chest pain in the emergency department: long-term outcome of a prospective blind study. Mayo Clin Proc. Apr 2010; 85(4):314-322.
  32. Lee KY, Hwang BH, Kim TH, et al. Computed tomography angiography images of coronary artery stenosis provide a better prediction of risk than traditional risk factors in asymptomatic individuals with type 2 diabetes: a long-term study of clinical outcomes. Diabetes Care. Sep 2017; 40(9):1241-1248.
  33. Lin JS. Nontraditional risk factors in cardiovascular disease risk assessment: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. Jul 17 2018; 320(3):281-297.
  34. Mamudu HM, Paul TK, Veeranki SP, et al. The effects of coronary artery calcium screening on behavioral modification, risk perception, and medication adherence among asymptomatic adults: a systematic review. Atherosclerosis. Oct 2014; 236(2):338-350.
  35. Martin SS, Blaha MJ, Blankstein R, et al. Dyslipidemia, coronary artery calcium, and incident atherosclerotic cardiovascular disease: implications for statin therapy from the multi-ethnic study of atherosclerosis. Circulation. Jan 7 2014; 129(1):77-86.
  36. Meyer M, Henzler T, Fink C, et al. Impact of coronary calcium score on the prevalence of coronary artery stenosis on dual source CT coronary angiography in Caucasian patients with an intermediate risk. Acad Radiol. Nov 2012; 19(11):1316-1323.
  37. Miedema MD, Duprez DA, Misialek JR, et al. Use of coronary artery calcium testing to guide aspirin utilization for primary prevention: estimates from the multi-ethnic study of atherosclerosis. Circ Cardiovasc Qual Outcomes. May 2014; 7(3):453-460.
  38. Nakanishi R, Li D, Blaha MJ, et al. All-cause mortality by age and gender based on coronary artery calcium scores. European heart journal cardiovascular Imaging. Nov 2016; 17(11):1305-1314.
  39. National Institute for Health and Care Excellence. Chest pain of recent onset: assessment and diagnosis [CG95]. 2016; www.nice.org.uk/guidance/cg95/chapter/Recommendations.
  40. O'Malley PG, Feuerstein IM, Taylor AJ. Impact of electron beam tomography, with or without case management, on motivation, behavioral change, and cardiovascular risk profile: a randomized controlled trial. JAMA. May 7 2003; 289(17):2215-2223.
  41. Petretta M, Daniele S, Acampa W, et al. Prognostic value of coronary artery calcium score and coronary CT angiography in patients with intermediate risk of coronary artery disease. Int J Cardiovasc Imaging. Aug 2012; 28(6):1547-1556.
  42. Polonsky TS, McClelland RL, Jorgensen NW, et al. Coronary artery calcium score and risk classification for coronary heart disease prediction. Jama. Apr 28 2010; 303(16):1610-1616.
  43. Pursnani A, Chou ET, Zakroysky P, et al. Use of coronary artery calcium scanning beyond coronary computed tomographic angiography in the emergency department evaluation for acute chest pain: the ROMICAT II trial. Circ Cardiovasc Imaging. Mar 2015; 8(3).
  44. Pursnani A, Massaro JM, D'Agostino RB, Sr., et al. Guideline-based statin eligibility, coronary artery calcification, and cardiovascular events. JAMA. Jul 14 2015; 314(2):134-141.
  45. Rozanski A, Gransar H, Shaw LJ, et al. Impact of coronary artery calcium scanning on coronary risk factors and downstream testing the EISNER (Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research) prospective randomized trial. J Am Coll Cardiol. Apr 12 2011; 57(15):1622-1632.
  46. Sabour S, Rutten A, van der Schouw YT, et al. Inter-scan reproducibility of coronary calcium measurement using Multi Detector-Row Computed Tomography (MDCT). Eur J Epidemiol. 2007; 22(4):235-243.
  47. Sarwar A, Shaw LJ, Shapiro MD, et al. Diagnostic and prognostic value of absence of coronary artery calcification. JACC. Cardiovascular imaging. Jun 2009; 2(6):675-688.
  48. Shreibati JB, Baker LC, McConnell MV, et al. Outcomes after coronary artery calcium and other cardiovascular biomarker testing among asymptomatic medicare beneficiaries. Circ Cardiovasc Imaging. Jul 2014; 7(4):655-662.
  49. Silverman MG, Blaha MJ, Krumholz HM, et al. Impact of coronary artery calcium on coronary heart disease events in individuals at the extremes of traditional risk factor burden: the Multi-Ethnic Study of Atherosclerosis. Eur Heart J. Sep 1 2014; 35(33):2232-2241.
  50. Smeeth L, Skinner JS, Ashcroft J, Hemingway H, Timmis A, Chest Pain Guideline Development G. NICE clinical guideline: chest pain of recent onset. Br J Gen Pract. Aug 2010; 60(577):607-610.
  51. Takamura K, Fujimoto S, Kondo T, et al. Incremental prognostic value of coronary computed tomography angiography: high-risk plaque characteristics in asymptomatic patients. J Atheroscler Thromb. Nov 1 2017; 24(11):1174-1185.
  52. Taylor AJ, Bindeman J, Feuerstein I, et al. Coronary calcium independently predicts incident premature coronary heart disease over measured cardiovascular risk factors: mean three-year outcomes in the Prospective Army Coronary Calcium (PACC) project. J Am Coll Cardiol. Sep 6 2005; 46(5):807-814.
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POLICY HISTORY:

Medical Policy Group, June 2005 (3)

Medical Policy Administration Committee, July 2005

Available for comment July 28-September 10, 2005

Medical Policy Group, June 2006 (3)

Medical Policy Group, November 2006 (3)

Medical Policy Administration Committee, January 2007

Available for comment January 10-February 23, 2007

Medical Policy Group, July 2007 (3)

Medical Policy Group, September 2007 (2)

Medical Policy Group, December 2007 (1)

Medical Policy Group, December 2008 (3)

Medical Policy Administration Committee, December 2008

Available for comment December 9, 2008-January 22, 2009

Medical Policy Group, March 2011 (2): Web site and reference update

Medical Policy Group, November 2011 (3): Updated: Policy section to include medically necessary indications for acute chest pain in low or intermediate risk patients in the emergency room setting, Key Points, References

Medical Policy Administration Committee, November 2011

Available for comment November 11 through December 27, 2011

Medical Policy Group, December 2011 (1)

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (3):  2014 Updates to Description, Key Points & References; no change in policy statement

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (3): 2015 Updates to Key Points, Approved by Governing Bodies and References; no change to policy statement.

Medical Policy Panel, October 2016

Medical Policy Group, January 2017 (3): 2016 Updates to Key Points & References; removed previous coding section as all deleted codes were greater than seven years old; no change in policy statement

Medical Policy Group, August 2017 (3): Individual policy created for computed tomography to detect coronary artery calcification as a stand-alone test, pulling previous applicable information from medical policy #230 Cardiac Computed Tomography (CCT), Cardiac Computed Tomography Angiography (CCTA); no change in policy statements.

Medical Policy Panel, September 2017

Medical Policy Group, October 2017 (3): 2017 Updates to Description, Key Points & References. No change in policy statement.

Medical Policy Panel, September 2018

Medical Policy Group, September 2018 (9): 2018 Updates to Key Points & References. No change in policy statement.

Medical Policy Group, August 2020 (2): Policy transitioning to AIM Radiology. Effective for dates of service on or after Septmeber 12, 2020 refer to PET, MRI, MRA, CT,CTA/CCTA.

 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.