MedStar Health, Inc. POLICY AND PROCEDURE MANUAL

MedStar Health, Inc. POLICY AND PROCEDURE MANUAL

SUBJECT: INDEX TITLE: ORIGINAL DATE:

POLICY NUMBER: MP.101.MH REVISION DATE: N/A

ANNUAL APPROVAL DATE: 02/15

PAGE NUMBER: 1 of 7 Transient Elastography (e.g., FibroScan)

Medical Management

January 2015

This policy applies to the following lines of business: (Check those that apply.)

COMMERCIAL [ ] HMO

[ ] PPO

[ ] Fully Insured [ ] Individual [ ] Marketplace [ X ] All

Product

(Exchange)

GOVERNMENT [ ] MA HMO [ ] MA PPO [ ] MA C-SNP [ ] MA D-SNP [ X ] MA All

PROGRAMS

[ ] Medicaid

OTHER

[ X ] Self-funded/ASO

I. POLICY

It is the policy of MedStar Health, Inc. to cover Subcutaneous Implantable Cardiac Defibrillators (S-ICDs) when medically necessary (refer to CRM.015.MH- Medical Necessity policy) and covered under the member's specific benefit plan.

II. DEFINITIONS

Ascites - the presence of excess fluid in the peritoneal cavity. It is a common clinical finding with a wide range of causes, but develops most frequently as a part of the decompensation of chronic liver disease.

Body Mass Index (BMI) - is a person's weight in kilograms (kg) divided by his or her height in meters squared.

METAVIR Score - helps interpret a liver biopsy. Fibrosis is graded on a 5-point scale from 0 to 4.

Fibrosis score:

F0 = no fibrosis

F1 = portal fibrosis without septa

F2 = portal fibrosis with few septa

F3 = numerous septa without cirrhosis

F4 = cirrhosis

UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc. and its affiliates.

Proprietary and Confidential Information of UPMC Health Plan ? 2015 UPMC All Rights Reserved

III. PURPOSE

POLICY NUMBER: MP.101.MH REVISION DATE: N/A

ANNUAL APPROVAL DATE: 02/15 PAGE NUMBER: 2 of 7

The purpose of this policy is to define the indications for medical necessity for transient elastography (TE) (e.g., FibroScan).

IV. SCOPE

This policy applies to MedStar Health, Inc. departments as indicated by the Benefit and Reimbursement Committee. These include but are not limited to Medical Management, Benefit Configuration and Claims Departments.

V. PROCEDURE

A. Medical Description / Background

Diagnosis, staging and treatment of patients with chronic hepatitis include staging of liver fibrosis. The gold standard for evaluating liver fibrosis remains percutaneous liver biopsy, although this procedure has inherent limitations. These include a risk for procedure related complications such as pain or bleeding.

Transient elastography (TE) (e.g., FibroScan) measures liver stiffness in patients. A mechanical vibrator produces low-amplitude elastic waves that travel through the skin and intercostal space into the liver. Ultrasound is used to track the shear wave and to measure its speed, which is correlated with the elasticity of the liver.

The examination is performed on a non-fasting patient lying supine with the right arm placed behind the head to facilitate access to the right upper quadrant of the abdomen. The tip of the probe transducer is placed on the skin between the rib bones, near the right lobe of the liver. The tip of the probe is at the same level where a traditional liver biopsy would be performed. Once the measurement area has been located, the operator presses the button on the probe to start an acquisition. The software determines whether each measurement is successful or not. Results correspond to the median of ten validated measurements.

TE has the advantages of being painless, rapid, and easy to perform at the bedside or in the outpatient clinic. Published studies have validated TE as a reliable method to identify F4 fibrosis (cirrhosis). However, TE is unable to reliably distinguish between F2 and F3 fibrosis. In addition, other factors besides fibrosis contribute to liver stiffness. Liver stiffness measurements have been consistently found to be falsely elevated in patients with acute hepatitis, inflammation, increased alanine transaminase (ALT),

UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc. and its affiliates.

Proprietary and Confidential Information of UPMC Health Plan ? 2015 UPMC All Rights Reserved

POLICY NUMBER: MP.101.MH REVISION DATE: N/A

ANNUAL APPROVAL DATE: 02/15 PAGE NUMBER: 3 of 7

extrahepatic cholestasis, hepatic congestion, hepatic amyloidosis, and recent food intake (within 60 minutes).

There are some patients in whom accurate readings cannot be obtained using TE. This is because the ultrasound-based technique requires an adequate visualization of the liver to obtain readings. Obesity, ascites, and liver inflammation are known potential barriers to achieving accurate results.

B. Indications

TE (e.g., FibroScan) is considered medically necessary and is therefore covered if the member meets any of the following criteria:

Initial assessment of fibrosis of members with a diagnosis with hepatitis C; or Follow-up assessment of fibrosis of members with a diagnosis of hepatitis C

and previously documented F0, F1, or F2 per METAVIR staging guidelines (refer to Definitions section) TE is considered experimental and investigational for all other indications.

C. Limitations

TE (e.g. FibroScan) is considered not medically necessary and is therefore not covered if the member meets any of the following criteria:

BMI of 30 kg/m2 Ascites Focal lesions within the liver (e.g., tumor) Acute liver injury Previously documented liver fibrosis of F3 or F4 Pregnant Alanine transaminase (ALT) level five or more times the upper limit of normal

(55 units per liter ) Implanted metal device (e.g., pacemaker, automated implantable cardioverter

defibrillator (AICD), or any other implantable defibrillators) TE performed within the previous 12 months Liver biopsy within the previous six months

D. Information Required for Review

In order to assess medical necessity for transient elastography, adequate information must be furnished by the treating physician. This includes, but is not limited to:

UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc. and its affiliates.

Proprietary and Confidential Information of UPMC Health Plan ? 2015 UPMC All Rights Reserved

POLICY NUMBER: MP.101.MH REVISION DATE: N/A

ANNUAL APPROVAL DATE: 02/15 PAGE NUMBER: 4 of 7

For initial request, documentation confirming the member has a diagnosis of hepatitis C.

For follow-up requests, documentation confirming the member has a diagnosis of hepatitis C and documentation of the member's METAVIR stage, including dates and scores.

Previous liver biopsy and transient elastography results, if applicable. BMI or most recent height and weight. ALT level within the past six weeks. Physician documentation of non-pregnant state, lack of ascites, and absence

of implanted metal device (e.g., pacemaker, automated implantable cardioverter defibrillator (AICD), or any other implantable defibrillators).

E. Review Process

1. The Medical Management staff assigned to review obtains the clinical information according to CRM.001.MH - Prior Authorization/Pre-Service Review policy, to determine if there is adequate clinical information. If the case does not meet the established criteria, it is referred to a Medical Director.

2. If referred, the Medical Director determines if the requested service is medically necessary and appropriate according to CRM.005.MH - Medical Director Referral, CRM .015.MH - Medical Necessity and CRM.032.MH Benefit Exception policy.

3. The Medical Management staff completes the review process and communicates the review decision according to the Timeliness of UM Decisions policy for the member's benefit plan (CRM.004.MH ? Timeliness of Utilization Management Decisions ? Medical Assistance; CRM.007.MH ? Timeliness of Utilization Management Decisions ? Commercial; CRM.022.MH ? Timeliness of Utilization Management Decisions ? Medicare).

F. Variations

N/A

G. Records Retention

Records Retention for documents, regardless of medium, are provided within the MedStar Health System Policy HS-LE0009 Records Retention, Management and Retirement, and as indicated in the MedStar Health Insurance Services Division Policy and Procedure CORP.028.MH Records Retention.

Unless otherwise mandated by Federal or State law, or unless required to be maintained for litigation purposes, any communications recorded pursuant to this Policy are maintained for a minimum of ten (10) years from the date of recording.

UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc. and its affiliates.

Proprietary and Confidential Information of UPMC Health Plan ? 2015 UPMC All Rights Reserved

POLICY NUMBER: MP.101.MH REVISION DATE: N/A

ANNUAL APPROVAL DATE: 02/15 PAGE NUMBER: 5 of 7

H. Codes

The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT code Description

91200

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

I. References

Medical Literature/Clinical Information:

1. . Table 4. The METAVIR System. Algorithm for Evaluation of Histological Activity. Copyright ?1994-2014 Hepatitis Central. Available at:

2. ECRI Institute. Health Technology Assessment Information Service: FibroScan (EchoSens) Transient Elastography for Determining Optimal Candidates for Hepatitis C Pharmacotherapy. Published: 10/09/2014.

3. Kemp W, Roberts S. FibroScan? and transient elastography. Aust Fam Physician. 2013 Jul;42(7):468-471.

4. Wong GL. Update of liver fibrosis and steatosis with transient elastography (Fibroscan). Gastroenterol Rep (Oxf). 2013 Jul;1(1):19-26. doi: 10.1093/gastro/got007. Epub 2013 Mar 26.

5. Afdahl NH. Fibroscan (transient elastography) for the measurement of liver fibrosis. Gastroenterol Hepatol (NY). 2012 Sep;8(9):605-607.

6. Crespo G, Fernandez-Varo G, Marino Z, et al. ARFI, FibroScan, ELF, and their combinations in the assessment of liver fibrosis: a prospective study. J Hepatol.

UPMC Health Plan and Evolent Health provide administrative functions and services on behalf of MedStar Health, Inc. and its affiliates.

Proprietary and Confidential Information of UPMC Health Plan ? 2015 UPMC All Rights Reserved

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