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Noninvasive Techniques for the Evaluation and Monitoring of Patients with Chronic Liver Disease

Policy Number: MP-237

Latest Review Date: December 2019

Category: Medical                                                                 

Policy Grade: B

POLICY:

Effective for dates of service on or after March 8, 2017:

A single FibroSure® multianalyte assay for the evaluation of patients with chronic liver disease may be considered medically necessary.

 

FibroSure® multianalyte assays for the monitoring of patients with chronic liver disease is considered not medically necessary and investigational.

 

Other multianalyte assays with algorithmic analyses for the evaluation or monitoring of patients with chronic liver disease is considered not medically necessary and investigational.

 

A single transient elastography (FibroScan®) imaging for the evaluation of patients with chronic liver disease may be considered medically necessary.

 

Transient elastography (FibroScan®) imaging for the monitoring of patients with chronic liver disease is considered not medically necessary and investigational.

 

Use of other noninvasive imaging, including but not limited to magnetic resonance elastography, acoustic radiation force impulse imaging, or real-time tissue elastrography for the evaluation or monitoring of patients with chronic liver disease is considered not medically necessary and investigational.

 

 

Effective for dates of service prior to March 8, 2017:

Combined serum markers of hepatic fibrosis, evaluated to produce a predictive score in the diagnosis and monitoring of patients with chronic liver disease, is considered not medically necessary and investigational.

 

Noninvasive imaging, including but not limited to transient elastography, magnetic resonance elastography, acoustic radiation force impulse imaging or real-time tissue elastrography for the evaluation and monitoring of chronic liver disease is considered not medically necessary and investigational.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Noninvasive techniques to monitor liver fibrosis are being investigated as alternatives to liver biopsy in patients with chronic liver disease. There are two options for noninvasive monitoring including: (1) multianalyte serum assays with algorithmic analysis of either direct or indirect biomarkers and (2) specialized radiologic methods, including magnetic resonance elastography (MRE), transient elastography, acoustic radiation force impulse imaging (ARFI), and real-time transient elastography (RTE).

 

Biopsy for Chronic Liver Disease

The diagnosis of non-neoplastic liver disease is often made from needle biopsy samples. In addition to establishing a disease etiology, liver biopsy can determine the degree of inflammation present and can stage the degree of fibrosis. The degree of inflammation and fibrosis may be assessed by different scoring schemes. Most of these scoring schemes grade inflammation from 0 to 4 (0 = no or minimal inflammation, 4 = severe) and fibrosis from 0 to 4 (0 = no fibrosis, 4 = cirrhosis). There are several limitations to liver biopsy, including its invasive nature, small tissue sample size, and subjective grading system. Regarding small tissue sample size, liver fibrosis can be patchy and thus missed on a biopsy sample, which includes only 0.002% of the liver tissue. A noninvasive alternative to liver biopsy would be particularly helpful, both to initially assess patients and then as a monitoring tool to assess response to therapy.  The implications of using liver biopsy as a reference standard are discussed in the Key Points.

 

Hepatitis C Virus

Infection with the hepatitis C virus (HCV) can lead to permanent liver damage. Before noninvasive tests were available, liver biopsy is typically recommended before the initiation of antiviral therapy. Repeat biopsies may be performed to monitor fibrosis progression. Liver biopsies are analyzed according to a histologic scoring system; the most commonly used one for hepatitis C is the Metavir scoring system, which scores the presence and degree of inflammatory activity and fibrosis. The fibrosis is graded from F0 to F4, with a Metavir score of F0 signifying no fibrosis and F4 signifying cirrhosis (which is defined as the presence throughout the liver of fibrous septa that subdivide the liver parenchyma into nodules and represents the final and irreversible form of disease). The stage of fibrosis is the most important single predictor of morbidity and mortality in patients with hepatitis C. Biopsies for hepatitis C are also evaluated according to the degree of inflammation present, referred to as the grade or activity level. For example, the Metavir system includes scores for necroinflammatory activity ranging from A0 to A3 (A0=no activity, A1=minimal activity, A2=moderate activity, A3=severe activity).

 

Hepatitis B Virus

Most people who become infected with hepatitis B virus (HBV) recover fully, but a small portion will develop chronic HBV, which can lead to permanent liver damage. As with HCV, identification of liver fibrosis is needed to determine timing and management of treatment: and liver biopsy is the criterion standard for staging fibrosis. The grading of fibrosis in HBV also uses the Metavir system.

 

Alcoholic Liver Disease (ALD)

Alcoholic liver disease (ALD) is the leading cause of liver disease in most Western countries. Histologic features of ALD usually include steatosis, alcoholic steatohepatitis (ASH), hepatocyte necrosis, Mallory bodies (tangled proteins seen in degenerating hepatocytes), a large polymorphonuclear inflammatory infiltrate, and, with continued alcohol abuse, fibrosis and possibly cirrhosis. The grading of fibrosis is similar to the scoring system used in hepatitis C. The commonly used Laënnec scoring system uses grades 0 to 4, with 4 being cirrhosis.

Non-alcoholic Fatty Liver Disease (NAFLD)

Nonalcoholic fatty liver disease (NAFLD) is defined as a condition that pathologically resembles ALD but occurs in patients who are not heavy users of alcohol. It may be associated with a variety of conditions, including obesity, diabetes, and dyslipidemia. The characteristic feature of NAFLD is steatosis. At the benign end of the spectrum of the disease, there is usually no appreciable inflammation, hepatocyte death, or fibrosis. In contrast, non-alcoholic steatohepatitis (NASH), which shows overlapping histologic features with ALD, is an intermediate form of liver damage, and liver biopsy may show steatosis, Mallory bodies, focal inflammation, and degenerating hepatocytes. NASH can progress to fibrosis and cirrhosis. A variety of histological scoring systems have been used to evaluate NAFLD. The NAFLD Activity Score system for NASH includes scores for steatosis (0-3), lobular inflammation (0-3), and ballooning (0-2). Cases with scores of 5 or greater are considered NASH, while cases with scores of 3 and 4 are considered borderline (probable or possible) NASH. The grading of fibrosis is similar to the scoring system used in hepatitis C. The commonly used Laënnec scoring system uses grades 0 to 4, with 4 being cirrhosis.

 

Noninvasive Alternatives to Liver Biopsy

Multianalyte Assays

A variety of non-invasive laboratory tests are being evaluated as an alternative to liver biopsy. Biochemical tests can be broadly categorized into indirect and direct markers of liver fibrosis. Indirect markers include liver function tests such as ALT (alanine aminotransferase), AST (aspartate aminotransferase), the ALT/AST ratio (also referred to as the AAR), platelet count, and prothrombin index. In recent years, there has been growing understanding of the underlying pathophysiology of fibrosis, leading to direct measurement of the factors involved. For example, the central event in the pathophysiology of fibrosis is activation of the hepatic stellate cell. Normally, the stellate cells are quiescent but are activated in the setting of liver injury, producing a variety of extracellular matrix (ECM) proteins. In normal livers, the rate of ECM production equals its degradation, but in the setting of fibrosis, production exceeds degradation. Metalloproteinases are involved in intracellular degradation of ECM, and a profibrogenic state exists when there is either a down regulation of metalloproteinases or an increase in tissue inhibitors of metalloproteinases (TIMP). Both metalloproteinases and TIMP can be measured in the serum, which directly reflects fibrotic activity. Other direct measures of ECM deposition include hyaluronic acid or alpha-2 macroglobulin.

 

While many studies have been done on these individual markers, or on groups of markers in different populations of patients with liver disease, there has been interest in analyzing multiple markers using mathematical algorithms to generate a score that categorizes patients according to the biopsy score. It is proposed that these algorithms can be used as an alternative to liver biopsy in patients with liver disease. The following proprietary, algorithm-based tests are commercially available in the U.S.

 

FibroSure® (Also Known as FibroTest™)

HCV FibroSure®

The HCV FibroSure® uses a combination of six serum biochemical indirect markers of liver function plus age and sex in a patented algorithm to generate a measure of fibrosis and necroinflammatory activity in the liver that correspond to the Metavir scoring system for stage (i.e., fibrosis) and grade (i.e., necroinflammatory activity). The measures are combined using a linear regression equation to produce a score between 0 and 1, with higher values corresponding to more severe disease. The biochemical markers include the readily available measurements of alpha-2 macroglobulin, haptoglobin, bilirubin, gamma glutamyl transpeptidase (GGT), ALT, and apolipoprotein A1. Developed in France, the test has been clinically available in Europe under the name FibroTest since 2003 and is exclusively offered by LabCorp in the United States as HCV FibroSure®.

 

ASH FibroSure®

ASH FibroSure™ (ASH Test) uses a combination of ten serum biochemical markers of liver function together with age, sex, height, and weight in a proprietary algorithm and is proposed to provide surrogate markers for liver fibrosis, hepatic steatosis, and alcoholic steatohepatitis (ASH). The biochemical markers include alpha-2 macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, GGT, ALT, AST, total cholesterol, triglycerides, and fasting glucose. The test has been available in Europe under the name ASH Test ™ (BioPredictive); however, the test is exclusively offered by LabCorp in the U.S. as ASH FibroSure®.

 

NASH FibroSure®

NASH FibroSure® (NASH Test) uses a proprietary algorithm of the same ten biochemical markers of liver function in combination with age, gender, height, and weight and is proposed to provide surrogate markers for liver fibrosis, hepatic steatosis, and NASH. The biochemical markers include alpha-2 macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, GGT, ALT, AST, total cholesterol, triglycerides, and fasting glucose. The test has been available in Europe under the name NASH Test™ (BioPredictive); however, the test is exclusively offered by LabCorp in the United States as NASH FibroSure®.

 

FIBROSpect II®

FIBROSpect II® uses a combination of three markers that directly measure fibrogenesis of the liver, analyzed with a patented algorithm. The markers include hyaluronic acid, TIMP-1, and alpha-2 macroglobulin. FIBROSpect® II is offered exclusively by Prometheus Laboratories.  The measures are combined using a logistic regression algorithm to generate a FIBROSpect® II index score, ranging from 1 to 100 (or sometimes reported between 0 and 1), with higher scores indicating more severe disease.

 

Noninvasive Imaging Technologies

Noninvasive imaging technologies to detect liver fibrosis or cirrhosis among patients with chronic liver disease are also being evaluated as an alternative to liver biopsy. The noninvasive imaging technologies include transient elastography (e.g., FibroScan®), magnetic resonance elastography (MRE), acoustic radiation force impulse imaging (ARFI; e.g., Acuson S2000™), and real-time tissue elastography (e.g., HI VISION™ Preirus). Noninvasive imaging tests have been used in combination with multianalyte serum tests such as FibroTest or FibroSure® with FibroScan.

 

Transient Elastography

Transient elastography (FibroScan®) uses a mechanical vibrator to produce mild amplitude and low-frequency (50 Hz) waves, inducing an elastic shear wave that propagates throughout the liver. Ultrasound tracks the wave, measuring its speed in kilopascals (kPa), which correlates with liver stiffness. Increases in liver fibrosis also increase liver stiffness and resistance of liver blood flow. Transient elastography does not perform as well in patients with ascites, higher body mass index, or narrow intercostal margins. Although FibroScan may be used to measure fibrosis, unlike liver biopsy it does not provide information on necroinflammatory activity and steatosis, nor is it accurate during acute hepatitis or hepatitis exacerbations.

 

Acoustic Radiation Force Impulse Imaging (ARFI)

ARFI uses an ultrasound probe to produce an acoustic “push” pulse, which generates shear waves that propagate in tissue to assess liver stiffness. ARFI elastography evaluates the wave propagation speed (measured in meters per second) to assess liver stiffness. The faster the shear wave speed, the harder the object. ARFI technologies include Virtual Touch™ Quantification and Siemens Acuson S2000™ system. ARFI elastography can be performed at the same time as a liver sonographic evaluation, even in patients with a significant amount of ascites.

 

Magnetic Resonance Elastography

MRE uses a driver to generate 60-Hz mechanical waves on the patient’s chest well. The magnetic resonance imaging (MRI) equipment creates elastograms by processing the acquired images of propagating shear waves in the liver using an inversion algorithm. These elastograms represent the shear stiffness as a pixel value in kilopascals. MRE has several advantages over ultrasound elastography, including: (1) the ability to analyze larger liver volumes; (2) the ability to analyze liver volumes of obese patients or patients with ascites; and (3) the ability to precisely analysis of viscoelasticity using a 3-dimensional displacement vector.

 

Real-Time Tissue Elastography

RTE is a type of strain elastography which uses a combined autocorrelation method to measure tissue strain caused by manual compression or a person’s heartbeat. The relative tissue strain is displayed on conventional color B mode ultrasound images in real time. Hitachi manufacturers the RTE devices, including one called HI VISION™ Preirus. The challenge is to identify a region of interest while avoiding areas likely to introduce artifacts, such as large blood vessels, the area near the ribs, and the surface of the liver. Areas of low strain increase as fibrosis progresses and strain distribution becomes more complex. Various subjective and quantitative methods have been developed to evaluate the results. RTE can be performed in patients with ascites or inflammation. This technology does not perform as well in severely obese individuals.

 

KEY POINTS:

The most recent literature update was through August 28, 2019.

 

Summary of Evidence

Multianalyte Serum Assays

For individuals who have chronic liver disease who receive FibroSure® serum panels, the evidence includes systematic reviews of more than 30 observational studies (>5000 patients). Relevant outcomes are test validity, morbid events, and treatment-related morbidity. FibroSure® has been studied in populations with viral hepatitis, nonalcoholic fatty liver disease, and alcoholic liver disease. There are established cutoffs, although they were not consistently used in validation studies. Given these limitations and the imperfect reference standard, it is difficult to interpret performance characteristics. However, for the purposes of deciding whether a patient has severe fibrosis or cirrhosis, FibroSure® results provide data sufficiently useful to determine therapy. Specifically, FibroSure® has been used as an alternative to biopsy to establish eligibility regarding the presence of fibrosis or cirrhosis in several RCTs that showed the efficacy of hepatitis C virus treatments, which in turn demonstrated that the test can identify patients who would benefit from therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals who have chronic liver disease who receive multianalyte serum assays for liver function assessment other than FibroSure®, the evidence includes systematic reviews of observational studies. The relevant outcomes are test validity, morbid events, and treatment-related morbidity. Studies have frequently included varying cutoffs, some of which were standardized and others not validated. Cut-off thresholds have often been modified over time, may be specific to certain patient populations, and in some cases, guideline recommendations differ from cut-offs designated by manufacturers and those utilized in studies. Other multianalyte serum tests (e.g., APRI, FIB-4) lack data on clinical validity and utility. There does not appear to be evidence of incremental benefit over clinical assessment using the individual laboratory assay components. Given these limitations and the imperfect reference standard, it is difficult to interpret performance characteristics. There is no direct evidence that other multianalyte serum assays improve health outcomes; further, it is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence on clinical validity. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Noninvasive Imaging

For individuals who have chronic liver disease who receive transient elastography, the evidence includes many systematic reviews of more than 50 observational studies (>10,000 patients). The relevant outcomes are test validity, morbid events, and treatment-related morbidity. Transient elastography (FibroScan) has been studied in populations with viral hepatitis, nonalcoholic fatty liver disease, and alcoholic liver disease. There are varying cutoffs for positivity. Failures of the test are not uncommon, particularly for those with high body mass index, but these failures often went undetected in analyses of the validation studies. Given these limitations and the imperfect reference standard, it can be difficult to interpret performance characteristics. However, for the purposes of deciding whether a patient has severe fibrosis or cirrhosis, the FibroScan results provide data sufficiently useful to determine therapy. In fact, FibroScan has been used as an alternative to biopsy to establish eligibility regarding the presence of fibrosis or cirrhosis in the participants of several RCTs. These RCTs showed the efficacy of hepatitis C virus treatments, which in turn demonstrated that the test can identify patients who would benefit from therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

For individuals who have chronic liver disease who receive noninvasive radiologic methods other than transient elastography for liver fibrosis measurement, the evidence includes systematic reviews of observational studies. The relevant outcomes are test validity, morbid events, and treatment-related morbidity. Other radiologic methods (e.g., magnetic resonance elastography, real-time transient elastography, acoustic radiation force impulse imaging) may have similar performance for detecting significant fibrosis or cirrhosis. Studies have frequently included varying cutoffs not prespecified or validated. Given these limitations and the imperfect reference standard, it is difficult to interpret performance characteristics. There is no direct evidence that other noninvasive radiologic methods improve health outcomes; further, it is not possible to construct a chain of evidence for clinical utility due to the lack of sufficient evidence on clinical validity. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Practice Guidelines and Position Statements

Nonalcoholic Fatty Liver Disease

American Gastroenterological Association et al

The 2018 practice guidelines on the diagnosis and management of nonalcoholic fatty liver disease (NAFLD), developed by the American Gastroenterological Association, the American Association for the Study of Liver Diseases (AASLD), stated that “NFS [NAFLD fibrosis score] or FIB-4 [Fibrosis-4] index are clinically useful tools for identifying NAFLD patients with higher likelihood of having bridging fibrosis (stage 3) or cirrhosis (stage 4).” It also cited VCTE [vibration controlled transient elastography] and MRE [magnetic resonance elastography] as “clinically useful tools for identifying advanced fibrosis in patients with NAFLD.”

 

National Institute for Health and Care Excellence

The NICE (2016) published guidance on the assessment and management of NAFLD. The guidance did not reference elastography. The guidance recommended the enhanced liver fibrosis test to test for advanced liver fibrosis, utilizing a cut-off enhanced liver fibrosis score of 10.51.

 

American Gastroenterological Association Institute

The American Gastroenterological Association Institute (2017) published guidelines on the role of elastography in chronic liver disease. The guidelines indicated that, in adults with NAFLD, VCTE has superior diagnostic sensitivity and specificity for diagnosing cirrhosis than the APRI or FIB-4 tests (very low quality of evidence). Moreover, the guidelines stated that, in adults with NAFLD, magnetic resonance-guided elastography has little or no increased diagnostic accuracy for identifying cirrhosis compared with VCTE in patients who have cirrhosis, and has higher diagnostic accuracy than VCTE in patients who do not have cirrhosis (very low quality of evidence).

 

Hepatitis B and C Viruses

National Institute for Health and Care Excellence

In 2013, NICE published guidance on the management and treatment of patients with hepatitis B. The guidance recommended offering transient elastography as the initial test in adults diagnosed with chronic hepatitis B, to inform the antiviral treatment decision (see Table 8).

Table 8. Antiviral Treatment Recommendations by Transient Elasticity Score

Transient Elasticity Score

Antiviral Treatment

>11 kPa

Offer antiviral treatment

6-10 kPa

Offer liver biopsy to confirm fibrosis level prior to offering antiviral treatment

<6 kPa plus abnormal (ALT)

Offer liver biopsy to confirm fibrosis level prior to offering antiviral treatment

<6 plus normal ALT

Do not offer antiviral treatment

ALT: alanine aminotransferase.

As of September 2016, NICE had placed a pause on the development of the guidance on hepatitis C, citing instability and costs in the availability of treatments for the condition.

 

American Association for the Study of Liver Diseases and Infectious Diseases Society of America

The 2016 AASLD and Infectious Diseases Society of America (IDSA) guidelines for testing, managing, and treating hepatitis C virus (HCV) recommend that for counseling and pretreatment assessment purposes, the following should be completed:

 

“Evaluation for advanced fibrosis, using liver biopsy, imaging, or noninvasive markers, is recommended in all persons with HCV infection to facilitate an appropriate decision regarding HCV treatment strategy and determine the need for initiating additional measures for the management of cirrhosis (e.g., hepatocellular carcinoma screening).

Rating: Class I, Level A [evidence and/or general agreement; data derived from multiple randomized trials, or meta-analyses]”

 

The guidelines note that there are several noninvasive tests to stage the degree of fibrosis in patients with hepatitis C. Tests included indirect serum biomarkers, direct serum biomarkers, and vibration-controlled liver elastography. The guidelines assert that no single method is recognized to have high accuracy alone and careful interpretation of these tests is required.

 

Chronic Liver Disease

American College of Radiology

The 2017 American College of Radiology appropriateness criteria rated 1-dimensional transient elastography as a 7 (usually appropriate) for the diagnosis of liver fibrosis in patients with chronic liver disease. The criteria noted, “This procedure is less reliable in diagnosing liver fibrosis and cirrhosis in patients with obesity or ascites.”

 

European Association for the Study of Liver Disease et al

The European Association for the Study of Liver Disease and the Asociacion Latinoamericana para el Estudio del Higado (EASL-ALEH) convened a panel of experts to develop clinical practice guidelines on the use of noninvasive tests to evaluate liver disease severity and prognosis, with results published in 2015. The publication provided a summary of the advantages and disadvantages of noninvasive techniques (serum biomarkers, imaging techniques). A summary of the joint recommendations for serum biomarkers and transient elastography is provided in Table 9.

Table 9. Recommendations for Serum Biomarkers and Transient Elastography

Biomarkers

QOE

SOR

“Serum biomarkers can be used in clinical practice due to high applicability (>95%) and good reproducibility.”

High

Strong

“TE can be considered the non-invasive standard for the measure of LS”

High

Strong

“Serum biomarkers are well-validated for chronic viral hepatitis…. They are less well-validated for NAFLD not validated in other chronic kidney diseases.”

High

Strong

"For the diagnosis of significant fibrosis a combination of tests with concordance may provide the highest diagnostic accuracy”

High

Weak

“All HCV patients should be screened to exclude cirrhosis by TE [or]… serum biomarkers.…”

High

Strong

“Non-invasive assessment including serum biomarkers or TE can be used as first line procedure for the identification of patients at low risk of severe fibrosis/cirrhosis”

High

Strong

“Follow-up assessment by either serum biomarkers or TE for progression of liver fibrosis should be used for NAFLD patients at a 3 year interval”

Moderate

Strong

HCV: hepatitis C virus; LS: liver stiffness; NAFLD: nonalcoholic fatty liver disease; QOE: quality of evidence; SOR: strength of recommendation; TE: transient elastography.

U.S. Preventive Services Task Force Recommendations

Not applicable.

 

KEY WORDS:

Serum markers, liver fibrosis, chronic liver disease, FibroSure®, FibroSpect®, FibroTest™, biochemical markers, biochemical serum markers, Fibroscan®, Acuson S2000™,

HI VISION™ Preirus™, AIXPLORER®, Virtual Touch, ActiTest™, SteatoTest™, Hepatitis B, HBV, Hepatitis C, HCV, nonalcoholic fatty liver disease, NAFLD, acoustic radiation force impulse imaging, ARFI, nonalcoholic steatohepatitis, NASH, ASH FibroSure®, NASH FibroSure®, and NASH Test™.

 

 

APPROVED BY GOVERNING BODIES:

In November 2008, Acuson S2000™ Virtual Touch (Siemens AG, Erlanger, Germany), which provides acoustic radiation force impulse imaging, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K072786).

In August 2009, AIXPLORER® Ultrasound System (SuperSonic Imagine, Aix en Provence, France), which provides shear wave elastography, was cleared for marketing by FDA through the 510(k) process (K091970).

In June 2010, Hitachi HI VISION™ Preirus™ Diagnostic Ultrasound Scantier (Hitachi Medical Systems America, Twinsburg, OH), which provides real-time tissue elastography, was cleared for marketing by FDA through the 510(k) process (K093466).

In April 2013, FibroScan® (EchoSens, Paris, France), which uses transient elastography, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K123806).

In February 2017, ElastQ® Imaging shear wave elastography (Royal Phillips, Amsterdam, and the Netherlands) was cleared for marketing by FDA through the 510(k) process (K163120).

 

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 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.

 

 

CURRENT CODING: 

CPT code:   

76391

Magnetic resonance (e.g., vibration) elastography

                                               (Effective 01/01/2019)

 

76981

Ultrasound elastography, entire organ

                                               (Effective 01/01/2019)

 

76982

Ultrasound elastography (Effective 01/01/2019)

76983

Ultrasound, elastography; each additional target lesion (List   separately in addition to code for primary procedure)

                                               (Effective 01/01/2019)

 

81596

Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory   activity in liver (Effective 01/01/2019)

83520

Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified

83883

Nephelometry, each analyte not elsewhere specified

84999

Unlisted chemistry procedure

91200

Liver elastography, mechanically induced shear wave (e.g., vibration), without imaging, with interpretation and report

0002M

Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis (ASH) (Effective 09/15/2012)

0003M

Liver disease, ten biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides) utilizing serum, prognostic algorithm reported as quantitative scores for fibrosis, steatosis and nonalcoholic steatohepatitis (NASH) (Effective 09/15/2012)

0014M

Liver disease, analysis of 3 biomarkers (hyaluronic acid [HA], procollagen III amino terminal peptide [PIIINP], tissue inhibitor of metalloproteinase 1 (Effective 04/01/2020)

0166U

Liver disease, 10 biochemical assays (?2-macroglobulin, haptoglobin, apolipoprotein A1, bilirubin, GGT, ALT, AST, triglycerides, cholesterol, fasting glucose) and biometric and demographic data, utilizing serum, algorithm reported as scores for fibrosis, necroinflammatory activity, and steatosis with a summary interpretation (Effective 04/01/2020)

  

If liver elastography is performed with ultrasound imaging, the following CPT category III code would be reported for the elastography in addition to the code for the ultrasound:

 

 

PREVIOUS CODING:          

 0001M

Infectious disease, HCV, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver (Effective 09/15/2012-Deleted 12/31/18 )

                        0346T

Ultrasound, elastography (Effective 01/01/2014-Deleted 12/31/18)

 

                                               

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  5. American Association for the Study of Liver Diseases and Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. 2016; hcvguidelines.org/sites/default/files/HCV-Guidance_October_2016_a.pdf. Accessed September 28, 2017.

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  21. Curry MP, O'Leary JG, Bzowej N, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med. Dec 31 2015; 373(27):2618-2628.

  22. European Association for Study of Liver. Asociacion Latinoamericana para el Estudio del Higado. EASL-ALEH Clinical Practice Guidelines: Non-invasive tests for evaluation of liver disease severity and prognosis. J Hepatol. Jul 2015; 63(1):237-264.

  23. Ferraioli G, Tinelli C, Malfitano A, et al. Performance of real-time strain elastography, transient elastography, and aspartate-to-platelet ratio index in the assessment of fibrosis in chronic hepatitis C. AJR Am J Roentgenol. Jul 2012; 199(1):19-25.

  24. Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. Dec 31 2015; 373(27):2608-2617.

  25. Foucher J, Chanteloup E, Vergniol J, et al. Diagnosis of cirrhosis by transient elastography (FibroScan): A prospective study. Gut 2006; 55(3): 403-408.

  26. Fraquelli M, Rigamonti C, Casazza G, et al. Reproducibility of transient elastography in the evaluation of liver fibrosis in patients with chronic liver disease. Gut. Jul 2007; 56(7):968-973.

  27. Friedrich-Rust M, Ong MF, Martens S, et al. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. Apr 2008;134(4):960-974.

  28. Friedrich-Rust M, Nierhoff J, Lupsor M, et al. Performance of Acoustic Radiation Force Impulse imaging for the staging of liver fibrosis: a pooled meta-analysis. J Viral Hepat. Feb 2012; 19(2):e212-219.

  29. Geng XX, Huang RG, Lin JM, et al. Transient elastography in clinical detection of liver cirrhosis: A systematic review and meta-analysis. Saudi J Gastroenterol. Jul-Aug 2016; 22(4):294-303.

  30. Giannini EG, Zaman A, Ceppa P, et al. A simple approach to noninvasively identifying significant fibrosis in chronic hepatitis C patients in clinical practice. J Clin Gastroenterol 2006; 40(6): 521-527.

  31. Guo Y, Parthasarathy S, Goyal P, et al. Magnetic resonance elastography and acoustic radiation force impulse for staging hepatic fibrosis: a meta-analysis. Abdom Imaging. Apr 2015; 40(4):818-834.

  32. Halfon, P, Imbert-Bismut F, et al. A prospective assessment of the interlaboratory variability of biochemical markers of fibrosis (FibroTest) and activity test (ActiTest) in patients with chronic liver disease. Comp Hepatol 2002; 1:3.

  33. Hong H, Li J, Jin Y, et al. Performance of real-time elastography for the staging of hepatic fibrosis: a meta-analysis. PLoS One. 2014; 9(12):e115702.

  34. Horowitz JM, Kamel IR, Arif-Tiwari H, et al. ACR Appropriateness Criteria(R) Chronic Liver Disease. J Am Coll Radiol. May 2017;14(5s):S103-s117.

  35. Houot M, Ngo Y, Munteanu M, et al. Systematic review with meta-analysis: direct comparisons of biomarkers for the diagnosis of fibrosis in chronic hepatitis C and B. Aliment Pharmacol Ther. Jan 2016; 43(1):16-29.

  36. Hu X, Qiu L, Liu D, et al. Acoustic Radiation Force Impulse (ARFI) Elastography for noninvasive evaluation of hepatic fibrosis in chronic hepatitis B and C patients: a systematic review and meta-analysis. Med Ultrason. Jan 31 2017;19(1):23-31.

  37. Ichikawa S, Motosugi U, Ichikawa T, et al. Magnetic resonance elastography for staging liver fibrosis in chronic hepatitis C. Magn Reson Med Sci. 2012;11(4):291-297.

  38. Imbert-Bismut F, Messous D, et al. Intra-laboratory analytical variability of biochemical markers of fibrosis (FibroTest) and activity (ActiTest) and reference ranges in health blood donors. Clinic Chem Lab Med 2004; 42: 323-333.

  39. Imbert-Bismut F, Ratio V, et al. Biochemical markers of liver fibrosis in patients with hepatitis C virus infection: A prospective study. Lancet 2001; 357: 1069-75.

  40. Ji D, Shao Q, Han P, et al. The frequency and determinants of liver stiffness measurement failure: a retrospective study of "real-life" 38,464 examinations. PLoS One. 2014; 9(8):e105183.

  41. Jiang W, Huang S, Teng H, et al. Diagnostic accuracy of point shear wave elastography and transient elastography for staging hepatic fibrosis in patients with non-alcoholic fatty liver disease: a meta-analysis. BMJ Open. Aug 23 2018;8(8):e021787. 

  42. Kobayashi K, Nakao H, Nishiyama T, et al. Diagnostic accuracy of real-time tissue elastography for the staging of liver fibrosis: a meta-analysis. Eur Radiol. Jan 2015; 25(1):230-238.

  43. Koizumi Y, Hirooka M, Kisaka Y, et al. Liver fibrosis in patients with chronic hepatitis C: noninvasive diagnosis by means of real-time tissue elastography--establishment of the method for measurement. Radiology. Feb 2011; 258(2):610-617.

  44. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. May 15 2014; 370(20):1879-1888.

  45. Kwok R, Tse YK, Wong GL, et al. Systematic review with meta-analysis: non-invasive assessment of nonalcoholic fatty liver disease--the role of transient elastography and plasma cytokeratin-18 fragments. Aliment Pharmacol Ther. Feb 2014; 39 (3):254-269.

  46. Lassailly G, Caiazzo R, Hollebecque A et al. Validation of noninvasive biomarkers (FibroTest, SteatoTest, and Nash Test) for prediction of liver injury in patients with morbid obesity. Eur J Gastroenterol Hepatol 2011; 23(6):499-506.

  47. Li Y, Huang YS, Wang ZZ, et al. Systematic review with meta-analysis: the diagnostic accuracy of transient elastography for the staging of liver fibrosis in patients with chronic hepatitis B. Aliment Pharmacol Ther. Feb 2016; 43(4):458-469.

  48. Lichtinghagen R, Bahr MJ.  Noninvasive diagnosis of fibrosis in chronic liver disease. Expert Rev Mol Diagn 2004; 4:715-26.

  49. Liu H, Fu J, Hong R, et al. Acoustic radiation force impulse elastography for the non-invasive evaluation of hepatic fibrosis in non-alcoholic fatty liver disease patients: a systematic review & meta-analysis. PLoS One. 2015; 10(7):e0127782.

  50. Liu H, Fu J, Hong R, et al. Acoustic radiation force impulse elastography for the non-invasive evaluation of hepatic fibrosis in non-alcoholic fatty liver disease patients: a systematic review & meta-analysis. PLoS One. Jul 2015; 10(7):e0127782.

  51. Mehta P, Ploutz-Snyder R, Nandi J, et al. Diagnostic accuracy of serum hyaluronic acid, FIBROSpect II, and YKL-40 for discriminating fibrosis stages in chronic hepatitis C. Am J Gastroenterol, April 2008; 103(4): 928-936.

  52. Mehta SH, Lau B, Afdhal NH, et al. Exceeding the limits of liver histology markers. J Hepatol. Jan 2009; 50(1):36-41.

  53. Mohamadnejad M, Montazeri G, Fazlollahi A, et al. Noninvasive markers of liver fibrosis and inflammation in chronic hepatitis B-virus related liver disease. Am J Gastroenterol 2006; 101(11): 2537-2545.

  54. National Institute for Health and Care Excellence (NICE). Hepatitis B (chronic): diagnosis and management [CG165]. 2013 June; www.nice.org.uk/guidance/CG165/chapter/1-Recommendations. Accessed October 7, 2019.

  55. National Institute for Health and Care Excellence (NICE). Non-alcoholic fatty liver disease (NAFLD): assessment and management [NG49]. 2016; www.nice.org.uk/guidance/ng49. Accessed October 7, 2019.

  56. Naveau S, Raynard B, Ratziu V et al. Biomarkers for the prediction of liver fibrosis in patients with chronic alcoholic liver disease. Clin Gastroenterol Hepatol 2005; 3(2):167-74.

  57. Nierhoff J, Chavez Ortiz AA, Herrmann E, et al. The efficiency of acoustic radiation force impulse imaging for the staging of liver fibrosis: a meta-analysis. Eur Radiol. Nov 2013; 23(11):3040-3053.

  58. Njei B, McCarty TR, Luk J, et al. Use of transient elastography in patients with HIV-HCV coinfection: A systematic review and meta-analysis. J Gastroenterol Hepatol. Oct 2016; 31(10):1684-1693.

  59. O'Shea RS, Dasarathy S, McCullough AJ, et al. Alcoholic liver disease. Hepatology. Jan 2010; 51(1):307-328.

  60. Park MS, Kim BK, Cheong JY, et al. Discordance between liver biopsy and FibroTest in assessing liver fibrosis in chronic hepatitis B. PLoS One. 2013; 8(2):e55759.

  61. Patel K, Gordon SC, et al. Evaluation of a panel of non-invasive serum markers to differentiate mild from moderate-to-advanced liver fibrosis in chronic hepatitis C patients.  J Hepatol 2004; 41:935-42.

  62. Patel K, Nelson DR, Rockey DC, et al. Correlation of FIBROSpect II with histologic and morphometric evaluation of liver fibrosis in chronic hepatitis C. Clin Gastroenterol Hepatol, February 2008; 6(2): 242-247.

  63. Pavlov CS, Casazza G, Nikolova D, et al. Transient elastography for diagnosis of stages of hepatic fibrosis and cirrhosis in people with alcoholic liver disease. Cochrane Database Syst Rev. 2015; 1:CD010542.

  64. Piscaglia F, Salvatore V, Di Donato R, et al. Accuracy of VirtualTouch Acoustic Radiation Force Impulse (ARFI) imaging for the diagnosis of cirrhosis during liver ultrasonography. Ultraschall Med. Apr 2011; 32(2):167-175.

  65. Poynard T, de Ledinghen V, Zarski JP, et al. Relative performances of FibroTest, Fibroscan, and biopsy for the assessment of the stage of liver fibrosis in patients with chronic hepatitis C: a step toward the truth in the absence of a gold standard. J Hepatol. Mar 2012; 56(3):541-548.

  66. Poynard T, McHutchison J, et al. Biochemical surrogate markers of liver fibrosis and activity in a randomized trial of peginterferon alfa 2b and ribavirin. Hepatol 2003; 38:481-492.

  67. Poynard T, Muntreanu M, et al. Prospective analysis of discordant results between biochemical markers and biopsy in patients with chronic hepatitis C. Clin Chemistry 2004; 50:1344-55.

  68. Poynard T, Ngo Y, Munteanu M, et al. Noninvasive markers of hepatic fibrosis in chronic hepatitis B. Curr Hepat Rep. Jun 2011;10(2):87-97.

  69. Poynard T, Ratziu V, Charlotte F et al. Diagnostic value of biochemical markers (NashTest) for the prediction of nonalcoholic steatohepatitis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol 2006; 6:34.

  70. Ratziu V, Massard J, Charlotte F et al. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol 2006; 6:6.

  71. Regev A, Berho M, Jeffers LJ, et al. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. Oct 2002; 97(10):2614-2618.

  72. Rockey DC and Bissell DM. Noninvasive measures of liver fibrosis. Hepatology 2006; 43 (2 Suppl 1): S113-120.

  73. Rockey DC, Caldwell SH, Goodman ZD, et al. Liver biopsy. Hepatology. Mar 2009; 49(3):1017-1044.

  74. Rosenberg WMC, Voelker M, et al. Serum markers detect the presence of liver fibrosis: A cohort study.  Gastroenterol 2004; 127:1704-13.

  75. Rossi E, Adams L, et al. Validation of the FibroTest biochemical markers score in assessing liver fibrosis in hepatitis C patients. Clin Chem 2003; 49:450-54.

  76. Runge JH, Bohte AE, Verheij J, et al. Comparison of interobserver agreement of magnetic resonance elastography with histopathological staging of liver fibrosis. Abdom Imaging. Apr 2014; 39(2):283-290.

  77. Salkic NN, Jovanovic P, Hauser G, et al. FibroTest/Fibrosure for significant liver fibrosis and cirrhosis in chronic Hepatitis B: a meta-analysis. Am J Gastroenterol. Jun 2014; 109(6):796-809.

  78. Sanyal AJ, Harrison SA, Ratziu V et al. The Natural History of Advanced Fibrosis Due to Nonalcoholic Steatohepatitis: Data From the Simtuzumab Trials. Hepatology, 2019 Apr 18. 

  79. Sebastiani G, Halfon P, Castera L et al. SAFE biopsy: a validated method for large-scale staging of liver fibrosis in chronic hepatitis C. Hepatology 2009; 49(6):1821-1827.

  80. Sebastiani G, Vario A, Guido M and Alberti A. Performance of noninvasive markers for liver fibrosis is reduced in chronic hepatitis C with normal transaminases. J Viral Hepat, March 2008; 15(3): 212-218.

  81. Shaheen AA, Wan AF, Myers RP. FibroTest and FibroScan for the prediction of hepatitis C-related fibrosis: a systematic review of diagnostic test accuracy. Am J Gastroenterol. Nov 2007; 102(11):2589-2600.

  82. Shi KQ, Tang JZ, Zhu XL, et al. Controlled attenuation parameter for the detection of steatosis severity in chronic liver disease: a meta-analysis of diagnostic accuracy. J Gastroenterol Hepatol. Jun 2014; 29(6):1149-1158.

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  87. Singh S, Venkatesh SK, Loomba R, et al. Magnetic resonance elastography for staging liver fibrosis in non-alcoholic fatty liver disease: a diagnostic accuracy systematic review and individual participant data pooled analysis. Eur Radiol. May 2016; 26(5):1431-1440.

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POLICY HISTORY:

Medical Policy Group, July 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment July 28-September 10, 2005

Medical Policy Group, July 2007 (1)

Medical Policy Group, July 2009 (1)

Medical Policy Group, August 16, 2011; Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, August 2012 (3): Added Administrative Codes for Multianalyte Assays with algorithmic analyses (0001M, 0002M, & 0003M)

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (3):  2015 Update to Title, Description, added investigational policy statement for noninvasive imaging (this has always been considered investigational), Key Points, Key Words, Approved by Governing Bodies, Code for 91200 and References; no change to policy intent.  Policy re-activated.

Medical Policy Group, November 2015:  2016 Annual Coding Update – added Key Word FibroTest™ related to code 0001M.

Medical Policy Panel, December 2016

Medical Policy Group, February 2017 (3):  Major updates to Description, Key Points, Governing Bodies, Key Words & References; Policy statements updated to reflect adding coverage criteria effective on March 8, 2017 for a single use of FibroSURE multianalyte assay and a single use of Transient elastography (FibroScan) for the evaluation of patients with chronic liver disease; all other uses remain investigational

Medical Policy Administration Committee, March 2017

Available for comment March 8 through April 21, 2017

Medical Policy Panel, November 2017

Medical Policy Group, November 2017 (3): 2017 Updates to Description, Key Points, Approved by Governing Bodies, Current Coding & References; no change to current Policy statements.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added CPT codes 76391, 76981, 76982, 76983, 81596, Moved CPT code 0001M, 0346T from Current coding section to Previous coding.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (3): Updates to Key Points, Practice Guidelines and Position Statements, and References. Key Words added: ActiTest™, SteatoTest™, Hepatitis B, HBV, Hepatitis C, HCV, nonalcoholic fatty liver disease, NAFLD, acoustic radiation force impulse imaging, ARFI, nonalcoholic steatohepatitis, NASH, ASH FibroSure®, NASH FibroSure®, and NASH Test™. No changes to policy statement.  

Medical Policy Panel, November 2019

Medical Policy Group, December 2019 (3): 2019 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Group, March 2020: Quarterly coding update.  Added new CPT codes 0014M and 0166U to Current Coding.

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.