Elastography Policy Number: PG0252 ADVANTAGE | ELITE | HMO Last Review: 09/24/2019

INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement.

SCOPE X Professional _ Facility

DESCRIPTION Elastography is a noninvasive, ultrasound image technique utilized to evaluate tissue elasticity or stiffness by measuring tissue displacement/distortion using ultrasonography or magnetic resonance compression. Elastography procedures include:  Vibration-controlled transient elastography (VCTE), also known as transient elastography (TE).This technique is used mainly by the FibroScan® system.  Magnetic resonance elastography (MRE).  Acoustic radiation force impulse imaging (ARFI).  Shear wave elasticity (SWE).  Real-time tissue elastography (RTE).

Transient elastography (TE) (e.g., FibroScan) involves a mechanical vibrator to produce mild amplitude and low frequency waves, inducing an elastic shear wave, in patients suspected of or known to have chronic disease, to produce a one-dimensional image of tissue stiffness. TE is based on the principle that fibrosis changes the elasticity and viscosity of tissue. By assessing the propagation of acoustic waves through liver tissue, the extent of fibrosis can be measured. Monitoring of the tissue compression and decompression with ultrasonography enables calculation of 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 , it does not provide information on necroinflammatory activity and steatosis, nor is it accurate during acute hepatitis or hepatitis exacerbations.

Magnetic resonance elastography (MRE) involves a pneumatic driver activated by a special MRE pulse sequence producing a color-scaled, quantitative, three-dimensional image. The pulse sequence is sensitive to the transmission of waves through the tissue.

Acoustic radiation force impulse (ARFI) elastography is a noninvasive method for detecting and staging hepatic fibrosis. Acoustic radiation force impulse imaging (ARFI) involves acoustic waves from a focused ultrasonographic beam creating a qualitative two-dimensional image. This creates a ‘push’ technique inside the tissue using the acoustic radiation force from a focused ultrasound beam. Softer tissue is more easily pushed than stiffer tissue, thus creating a map a tissue stiffness.

Shear wave elasticity (SWE) involves measuring the shear waves produced from focus beams of ultrasound energy from conventional transducers producing movement within the tissue. The process provides a 2- dimensional map of tissue elasticity or stiffness.

Real-time tissue elastography (RTE) evaluates reproducible differences in backscattered ultrasound signals that

PG0252 – 12/18/2020 result from compression of tissues and uses color Doppler to generate an image of tissue movement in response to the external vibrations.

Noninvasive Imaging Technologies to Test for Hepatic Fibrosis Hepatic fibrosis causes progressive stiffening of liver tissue. Approximately 3.2 million people in the United States have chronic virus (HCV) infections, which puts them at risk for hepatic fibrosis, development of , a need for liver transplantation, and possible death due to cirrhosis or liver cancer. Liver fibrosis and chronic cirrhosis are the result of chronic liver injury, due to viral etiologies , C or E or of toxins such as alcohol.

A biopsy is the standard assessment procedure of fibrosis and cirrhosis in liver disease. However, a biopsy has its limitations and risk, i.e. an invasive procedure, potential risk of complications, risk of sampling error.

Noninvasive techniques to monitor liver fibrosis are being investigated as alternatives to liver biopsy in patients with chronic liver disease. Options for noninvasive monitoring include specialized radiologic methods.

POLICY Non-invasive elastography tests for hepatic fibrosis that are covered without a prior authorization:  Vibration-controlled transient elastography (VCTE), transient elastography (TE). (e.g., FibroScan)  Magnetic resonance elastography (MRE)  Acoustic radiation force impulse imaging (ARFI)

Non-invasive elastography tests for hepatic fibrosis that are non-covered (but not limited to):  Angiotensin converting enzyme  Real-time tissue elastography (RTE) (e.g., HI VISION Preirus) (0346T)  FibroMAX  FibroSpect  HepaScore  Micro-fibrillar associated glycoprotein 4 (MFAP4)  MicroRNA-21  miR-29a and miR-122  miRNA-221 and miRNA-222  Aspartate aminotransferase (AST) to platelet ratio (APRI)  FIB-4  HCV FibroSURE or FibroTest (0001M)  ASH FibroSURE (0002M)  NASH FibroSURE (0003M)  Plasma cytokeratin-18  Signal-induced proliferation-associated 1 like 1 (SIPA1L1).

Non-invasive elastography tests for any other indication is considered experimental, investigational or unproven, including but not all-inclusive, breast, thyroid, and melanoma.

COVERAGE CRITERIA HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan, Advantage Paramount considers vibration-controlled transient elastography (VCTE), transient elastography (TE). (e.g., FibroScan) medically indicated to assess the degree of advanced liver fibrosis and cirrhosis in an individual with hepatitis C, hepatitis B, chronic and/or all other chronic liver diseases.

Performance of transient elastography more than twice per year is considered not medically necessary.

Performance of transient elastography within six months following a liver biopsy is considered not medically

PG0252 – 12/18/2020 necessary.

Transient elastography is considered experimental and investigational for all other indications.

Paramount considers magnetic resonance elastography (MRE) medically indicated to assess individuals with non-alcoholic fatty liver disease, distinguishing hepatic cirrhosis from non-cirrhosis, with a high risk of cirrhosis. Risk factors include advanced age (65 years old or greater), obesity (BMI 30 or higher), diabetes and/or alanine aminotransferase (ALT) greater than twice the upper limit of normal.

Magnetic resonance elastography (MRE) is considered experimental and investigational and/or unproven for all other indications.

Paramount considers acoustic radiation force impulse imaging (ARFI) medically indicated when used to conjunctions with simple biomarkers (e.g., Fib4 and/or APRI) in the evaluation Hepatitis C as an alternative to liver biopsy.

Acoustic radiation force impulse imaging (ARFI) is considered experimental and investigational and/or unproved for all other indications.

The use of other non-invasive tests for hepatic fibrosis for any indication or testing other than those listed above including, but may not be limited to, the following:  Angiotensin converting enzyme  Real-time tissue elastography (RTE) (e.g., HI VISION Preirus) (0346T)  FibroMAX  FibroSpect  HepaScore  Micro-fibrillar associated glycoprotein 4 (MFAP4)  MicroRNA-21  miR-29a and miR-122  miRNA-221 and miRNA-222  Aspartate aminotransferase (AST) to platelet ratio (APRI)  FIB-4  HCV FibroSURE or FibroTest (0001M)  ASH FibroSURE (0002M)  NASH FibroSURE (0003M)  Plasma cytokeratin-18  Signal-induced proliferation-associated 1 like 1 (SIPA1L1).

Paramount has determined these procedures are experimental and investigational and therefore non-covered because there is insufficient evidence in the peer-reviewed medical literature of the effectiveness of these procedures.

Advantage Providers can request prior authorization to exceed coverage or benefit limits for members under age 21.

CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES 76391 MAGNETIC RESONANCE (EG, VIBRATION) ELASTOGRAPHY 76981 ULTRASOUND, ELASTOGRAPHY; PARENCHYMA (EG, ORGAN) 76982 ULTRASOUND, ELASTOGRAPHY; FIRST TARGET LESION

PG0252 – 12/18/2020 ULTRASOUND, ELASTOGRAPHY; EACH ADDITIONAL TARGET LESION (LIST SEPARATELY 76983 IN ADDITION TO CODE FOR PRIMARY PROCEDURE) LIVER ELASTOGRAPHY, MECHANICALLY INDUCED SHEAR WAVE (EG, VIBRATION), 91200 WITHOUT IMAGING, WITH INTERPRETATION AND REPORT ULTRASOUND, ELASTOGRAPHY (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY 0346T PROCEDURE) (CODE DELETED IN 2019)

ICD-10 Codes B17.0 ACITE DELTA-(SUPER) INFECTION OF HEPATITIS B CARRIER B17.10 ACUTE HEPATITIES C WITHOUT HEPATIC COMA B17.11 ACUTE HEPATITIES C WITH HEPATIC COMA B17.8 OTHER SPECIFIED ACUTE B17.9 ACUTE VIRAL HEPATITIES, UNSPECIFIED B18.0 CHRONIC VIRAL HEPATITIS B WITH DELTA-AGENT B18.1 CHRONIC VIRAL HEPATITIS B WITHOUT DELTA-AGENT B18.2 CHRONIC VIRAL HEPATITIES C B18.8 OTHER CHRONIC VIRAL HEPATITIS B18.9 CHRONIC VIRAL HEPATITIS, UNSPECIFIED B19.10 UNSPECIFIED VIRAL HEPATITIS B WITHOUT HEPATIC COMA B19.20 UNSPECIFIED VIRAL HEPATITIS C WITHOUT HEPATIC COMA B19.9 UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA E83.110 HEREDITARY HEMOCHROMATOSIS K70.0 ALCOHOLIC FATTY LIVER K70.10 ALCOHOLIC HEPATITIS WITHOUT ACITIES K70.11 ALCOHOLIC HEPATITIS WITH ASCITES K70.2 ALCOHOLIC FIBROSIS AND SCLEROSIS OF LIVER K70.30 ALCOHOLIC CIRRHOSIS OF LIVER WITHOUT ASCITIS K70.31 ALCOHOLIC CIRRHOSIS OF LIVER WITH ASCITIS K70.40 ALCOHOLIC HEPATIC FAILURE WITHOUT COMA K70.9 ALCOHOLIC LIVER DISEASE, UNSPECIFIED K71.7 TOXIC LIVER DISEASE WITH FIBROSIS AND CIRRHOSIS OF LIVER K73.0 CHRONIC PERSISTENT HEPATITS, NOT ELSEWHERE CLASSIFIED K73.1 CHRONIC LOBULAR HEPATITIS, NOT ELSEWHERE CLASSIFIED K73.2 CHRONIC ACTIVE HEPATITIS, NOT ELSEWHERE CLASSIFIED K73.8 OTHER CHRONIC HEPATITIS, NOT ELSEWHERE CLASSIFIED K73.9 CHRONIC HEPATITIS, UNSPECIFIED K74.0 HEPATIC FIBROSIS K74.2 HEPATIC FIBROSIS WITH HEPATIC SCLEROSIS K74.60 UNSPECIFIED CIRRHOSIS OF LIVER K74.69 OTHER CIRRHOSIS OF LIVER K75.4 AUTOIMMUNE HEPATITIS K75.9 INFLAMMATORY LIVER DISEASE, UNSPECIFIED K76.89 OTHER SPECIFIED DISEASES OF LIVER K76.9 LIVER DISEASE, UNSPECIFIED R74.0 NONSPECIFIC ELEVATION OF LEVELS OF TRANSAMINASE AND LACTIC ACID DEHYDOGENASE (LDH) R74.8 ABNORMAL LEVELS OF OTHER SERUM ENZYMES R74.9 ABNORMAL SERUM ENZYME LEVEL, UNSPECIFIED R76.8 OTHER SPECIFIED ABNORMAL IMMUNOLOGICAL FINDINGS IN SERUM R76.9 ABNORMAL IMMUNOLOGICAL FINDING IN SERUM, UNSPECIFIED R79.0 ABMORMAL LEVEL OF BLOOD MINERAL

PG0252 – 12/18/2020 R79.89 OTHER SPECIFIED ABNORMAL FINDINGS OF BLOOD CHEMISTRY R79.9 ABNORMAL FINDING OF BLOOD CHEMISTRY, UNSPECIFIED R93.2 ABNORMAL FINDINGS ON DIAGNOSITC IMAGING OF LIVER OR BILLARY TRACT R94.5 ABNORMAL RESULTS OF LIVER FUNCTION STUDIES Z48.23 ENCOUNTER FOR AFTERCARE FOLLOWING LIVER TRANSPLANT Z94.4 LIVER TRANSPLANT STATUS

REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 10/24/2014 10/24/14: Policy created to reflect most current clinical evidence per TAWG. 12/02/14: Added new 2015 CPT code 91200. 07/09/15: Changed title from Elastography to Ultrasound Transient Elastography. Transient elastography is now covered. 08/20/15: Transient elastography (91200) will no longer require prior authorization. Procedure 0346T is non-covered. Policy reviewed and updated to reflect most current clinical evidence per TAWG. 03/13/18: Changed title from Ultrasound Transient Elastography to Noninvasive Tests for Hepatic Fibrosis. Added codes 0001M-0003M as non-covered for all product lines. Added these non-invasive tests for hepatic fibrosis as non- covered for all product lines: Acoustic radiation force impulse imaging (ARFI) (e.g., Virtual Touch Imaging – Acuson S2000-3000), Magnetic resonance elastography (MRE), FibroMAX, FibroSpect, HepaScore, Aspartate aminotransferase (AST) to platelet ratio (APRI), FIB-4, HCV FibroSURE or FibroTest (0001M), ASH FibroSURE (0002M), & NASH FibroSURE (0003M). Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 09/24/19: Changed title from Noninvasive Tests for Hepatic Fibrosis to Elastography. Updated with the 2019 CPT codes. Added allowed/covered diagnosis codes. Determined coverage for Transient elastography (TE), Magnetic resonance elastography (MRE), Acoustic radiation force impulse imaging (ARFI) related to cirrhosis of liver. 12/18/2020: Medical policy placed on the new Paramount Medical Policy Format

REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT®) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review Hayes, Inc.

PG0252 – 12/18/2020