This panel consists of the following tests:

Hepatitis is an inflammation of the liver resulting from viruses, drugs, toxins, and other etiologies. Viral hepatitis can be due to one of at least five different viruses, designated Hepatitis A, B, C, D, and E. Most cases are caused by Hepatitis A virus (HAV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).

HAV is the most common cause of hepatitis in children and adolescents in the United States. Prior exposure is indicated by a positive IgG anti-HAV. Acute HAV is diagnosed by IgM anti-HAV, which typically appears within four weeks of exposure, and which disappears within three months of its appearance. IgG anti-HAV is similar in the timing of its appearance, but it persists indefinitely. Its detection indicates prior effective immunization or recovery from infection. Although HAV is spread most commonly by fecal-oral exposure, parenteral infection is possible during the acute viremia stage of the disease. After exposure, standard immune globulin may be effective as a prophylaxis.

HBV produces three separate antigens (surface, core, and e (envelope) antigens) when it infects the liver, although only hepatitis B surface antigen (HBsAg) is included as part of this panel. Following exposure, the body normally responds by producing antibodies to each of these antigens; one of which is included in this panel: hepatitis B surface antibody (HBsAb)-IgM antibody , HBsAg is the earlier marker, appearing in serum four to eight weeks after exposure, and typically disappearing within six months after its appearance. If HBsAg remains detectable for greater than six months, this indicates chronic HBV infection. HBcAb, in the form of both IgG and IgM antibodies, are next to appear in serum, typically becoming detectable two to three months following exposure. The IgM antibody gradually declines or disappears entirely one to two years following exposure, but the IgG usually remains detectable for life. Because HBsAg is present for a relatively short period and usually displays a low titer, a negative result does not exclude an HBV diagnosis. HBcAb, on the other hand, rises to a much higher titer and remains elevated for a longer period of time, but a positive result is not diagnostic of acute disease, since it may be the result of a prior infection. The last marker to appear in the course of a typical infection is HBsAb, which appears in serum four to six months following exposure, remains positive indefinitely, and confers immunity. HBV is spread exclusively by exposure to infected blood or body fluids; in the U.S., sexual transmission accounts for 30% to 60% of new cases of HBV infection.

The diagnosis of acute HBV infection is best established by documentation of a positive IgM antibody against the core antigen (HBcAb-IgM) and by identification of a positive hepatitis B surface antigen (HBsAg). The diagnosis of chronic HBV infection is established primarily by identifying a positive hepatitis B surface antigen (HBsAg) and demonstrating positive IgG antibody directed against the core antigen (HBcAb-IgG). Additional tests such as Hepatitis B e antigen (HBeAg) and Hepatitis B e antibody (HBeAb), the envelope antigen and antibody, are not included in the Hepatitis Panel, but may be of importance in assessing the infectivity of patients with HBV. Following completion of a HBV vaccination series, HBsAb alone may be used monthly for up to six months, or until a positive result is obtained, to verify an adequate antibody response.

HCV is the most common cause of post-transfusion hepatitis; overall HCV is responsible for 15% to 20% of all cases of acute hepatitis, and is the most common cause of chronic liver disease. The test most commonly used to identify HCV measures HCV antibodies, which appear in blood two to four months after infection. False positive HCV results can occur. For example, a patient with a recent yeast infection may produce a false positive anti-HCV result. For this reason, at present positive results usually are confirmed by a more specific technique. Like HBV, HCV is spread exclusively through exposure to infected blood or body fluids.

This panel of tests is used for differential diagnosis in a patient with symptoms of liver disease or injury. When the time of exposure or the stage of the disease is not known, a patient with continued symptoms of liver disease despite a completely negative Hepatitis Panel may need a repeat panel approximately two weeks to two months later to exclude the possibility of hepatitis. Once a diagnosis is established, specific tests can be used to monitor the course of the disease.

Indications

1. To detect viral hepatitis infection when there are abnormal liver function test results, with or without signs or symptoms of hepatitis.
2. Prior to and subsequent to liver transplantation.

Limitations

After a hepatitis diagnosis has been established, only individual tests, rather than the entire panel, are needed.

With the exception of routine or screening, any diagnosis other than those listed under the "Covered Diagnosis Codes" section will be denied as not medically necessary.  A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records. 

Hepatitis testing for routine or screening purposes is excluded from coverage.  Therefore, any diagnosis code listed under the "Screening Diagnosis Codes" section will deny as not covered.  The provider can bill the member for the non-covered service.

NOTE:

A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without a diagnosis code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. Also, if a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency.

Documentation Requirements

Failure to provide documentation of the medical necessity of tests may result in denial of claims. Such documentation may include notes documenting relevant signs, symptoms or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.

Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

National Coverage Determination - 190.33

On-Line NCD Coding Policy Manual and Change Report

Transmittal 534, CR 3806

Transmittal 651, CR 4005

Transmittal 758, CR 4161

Transmittal 864, CR 4328

Transmittal 1050, CR 5293

Transmittal 1531, CR 6084

Transmittal 1606, CR 6213

Transmittal 1645, CR 6304

Transmittal 1766, CR 6548

Transmittal 1963, CR 6964

Transmittal 2001, CR 7057

Covered Diagnosis Codes (Applicable to code 80074)

Non-covered Diagnosis Codes (Applicable to code 80074)

Screening Diagnosis Codes (Applicable to code 80074)