National Coverage Determination (NCD)

Hepatitis Panel/Acute Hepatitis Panel

190.33

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Tracking Information

Publication Number
100-3
Manual Section Number
190.33
Manual Section Title
Hepatitis Panel/Acute Hepatitis Panel
Version Number
1
Effective Date of this Version
11/25/2002
Implementation Date
01/01/2003

Description Information

Benefit Category
Diagnostic Laboratory Tests


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

This panel consists of the following tests:

  • Hepatitis A antibody (HAAb), IgM Antibody;
  • Hepatitis B core antibody (HBcAb), IgM Antibody;
  • Hepatitis B surface antigen (HBsAg); and
  • Hepatitis C antibody.

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 and Limitations of Coverage

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.

Note: Scroll down for links to the quarterly Covered Code Lists (including narrative).

Cross Reference

Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking.

Transmittal Information

Transmittal Number
17
Revision History

07/2002 - Implemented NCD. Effective date 11/25/02.  Implementation date 1/01/03. (TN AB-02-110) (CR 2130)

07/2004 - Published NCD in the NCD Manual without change to narrative contained in PM AB-02-110. Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. (TN 17) (CR 2130)

Other

Covered Code Lists (including narrative)

January 2023 (PDF) (ICD-10)
October 2022 (PDF) (ICD-10)
July 2022 (PDF) (ICD-10)
April 2022 (PDF) (ICD-10)
January 2022 (PDF) (ICD-10)
October 2021 (PDF) (ICD-10)
July 2021 (PDF) (ICD-10)
April 2021 (PDF) (ICD-10)
January 2021 (PDF) (ICD-10)
October 2020 (PDF) (ICD-10)
July 2020 (PDF) (ICD-10)
April 2020 (PDF) (ICD-10)
January 2020 (PDF) (ICD-10)
October 2019 (PDF) (ICD-10)
July 2019 (PDF) (ICD-10)
April 2019 (PDF) (ICD-10)
January 2019 (PDF) (ICD-10)
October 2018 (PDF) (ICD-10)
July 2018 (PDF) (ICD-10)
April 2018 (PDF) (ICD-10)
January 2018 (ICD-10)
October 2017 (ICD-10)
July 2017 (ICD-10)
April 2017 (ICD-10)
January 2017 (ICD-10)
October 2016 (ICD-10)
January 2016 (ICD-10)
October 2015 (ICD-10, ICD-9)
October 2014 (ICD-10, ICD-9)

Changes to Lab NCD Edit Software

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October 2021
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October 2019
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October 2018
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October 2014

Additional Information

Other Versions
Title Version Effective Between
Hepatitis Panel/Acute Hepatitis Panel 1 11/25/2002 - N/A You are here