L28852

 

HEPATITIS B SURFACE ANTIBODY AND SURFACE ANTIGEN

 

10/01/2010

 

Indications and Limitations of Coverage and/or Medical Necessity

HEPATITIS B SURFACE ANTIBODY

• Medicare will consider coverage for the Hepatitis B surface antibody (86706) for any of the following indications:

o To confirm the resolution of a recent hepatitis B infection.

 The HBsAb is drawn one month after the diagnosis of acute hepatitis B is made.

 This test may be repeated monthly while seeking the disappearance of HBsAg and the appearance of HBsAb indicating immunity and recovery.

 If the HBsAg is still evident at the end of six months of testing, the patient is considered a persistent hepatitis B carrier.

 No further HBsAb would be considered reasonable and necessary.

o After percutaneous or mucosal exposure to blood and/or serum-derived fluids when the SOURCE is HBsAg-positive and the previously vaccinated exposed person is either a known responder or the response to vaccination is unknown, in order to determine adequate antibody response.

 One test would be sufficient to make this determination.

• EXCEPTION- Vaccinated persons who have not been tested within the past 24 months should undergo testing to determine immunity.

o After percutaneous or mucosal exposure to blood and/or serum-derived fluids when the SOURCE is not tested or unknown and the previously vaccinated exposed person’s response to the vaccination is unknown, in order to determine adequate antibody response.

 One test would be sufficient to make this determination.

o Following the administration of the Hepatitis B vaccine series in order to determine adequate antibody response.

 Coverage for this indication is limited to two instances.

• To determine the antibody response of vaccination due to prophylaxis treatment following percutaneous and/or mucosal exposure.

• To determine the antibody response of vaccination following a Medicare reimbursed vaccination furnished to a beneficiary who is at high or intermediate risk of contracting hepatitis B.

o It is recommended this testing occur between one to six months following the completion of the series.

 If the patient was given Hepatitis B immunoglobulin (HBIg) during this time period, the testing should be delayed until four to six months after the HBIg administration.

 Those beneficiaries, who do not respond to the initial vaccination series, can receive up to three additional doses of vaccine at one to two month intervals.

 Serologic testing can occur following each dose.

o To determine the serological status of a hemodialysis, intermittent peritoneal dialysis, or continuous cycling peritoneal dialysis patient upon entry into a Medicare dialysis facility in accordance with CMS National coverage policy. Further testing is dependent upon the initial result and the vaccination status. Please refer to the following table:

 Vaccination and Serologic Status - Freq. of HBsAb Surveillance.

 Unvaccinated.

 Susceptible – Semiannually.

 HBsAg Carrier – None.

 HBsAb positive (*) – Annually.

 Vaccinated.

 HBsAb positive (*) – Annually.

 HBsAb of 9 or less SRUs by RIA – Semiannually.

 * At least 10 sample ratio units (SRUs) by radioimmunoassay or positive by enzyme immunoassay.

• Antibody titers 10 mlU/ml are recognized as conferring protection against hepatitis.

• ESRD patients who are in the process of receiving the hepatitis B vaccine, but have not completed the series, should be followed as susceptible.

o Between one and six months following the final vaccine dose, all patients should be tested for HBsAb response to the vaccine.

o Once the response is confirmed as positive, there is no further need to perform semiannual HBsAb tests.

o If, during future annual HBsAb testing, it is determined that the SRUs drop below 10 or the result by EIA is negative, a booster dose of hepatitis B vaccine should be given.

o A booster dose, otherwise known as re-vaccination, requires the complete three-injection-series be repeated.

HEPATITIS B SURFACE ANTIGEN

• Medicare will consider coverage for the Hepatitis B surface antigen (87340) for any of the following indications:

o To aid in the differential diagnosis of hepatitis when the patient presents with signs and symptoms of acute viral infection. If the initial HBsAg test is positive with the Anti-HBc-IgM being negative, both of these tests are repeated in two weeks.

 The results of the repeat tests aid in the differential diagnosis of acute HBV infection vs. chronic HBV carrier status.

 If the initial HBsAg test is positive with the Anti-HBc-IgM being positive, HBV infection is confirmed.

 The hepatitis B surface antigen test can be repeated monthly until negative.

 If, at the end of six months, the hepatitis B surface antigen remains positive, the beneficiary is diagnosed as a chronic HBV carrier and further hepatitis B surface antigen testing would not be reasonable or necessary.

o To evaluate patients with chronic elevations (6 months or longer) of the following serum liver enzyme levels: alanine aminotransferase (ALT) and aspartane aminotransferase (AST) to rule out the diagnosis of Hepatitis B.

 It is expected that only one HBsAg test will be required in this clinical situation (ICD-9 code 790.4).

o To evaluate patients with polyarteritis nodosa to determine if the illness is associated with replicating hepatitis B.

 In this instance HBsAg and HBeAg would be evaluated.

 It is expected that only one HBsAg test will be required (ICD-9 code 446.0)

o To determine the serological status of a hemodialysis, intermittent peritoneal dialysis, or continuous cycling peritoneal dialysis patient upon entry into a Medicare dialysis facility in accordance with CMS National coverage policy.

o Further testing is dependent upon the initial result as well as the vaccination status.

o Please refer to the following table:

 Vaccination and Serologic Status - Freq. of HBsAg Surveillance.

 Unvaccinated.

 Susceptible – Monthly.

 HbsAg Carrier – Annually.

 HbsAb positive (*) – None.

 Vaccinated.

 HbsAb positive (*) – None.

 HbsAb of 9 or less SRUs by RIA – Monthly.

 * At least 10 sample ratio units (SRUs) by radioimmunoassay or positive by enzyme immunoassay.

• Antibody titers 10 mlU/ml are recognized as conferring protection against hepatitis B.

• ESRD patients who are in the process of receiving the hepatitis B vaccine, but have not completed the series, should be followed as susceptible.

o Between one and six months following the final vaccine dose, all patients should be tested for HBsAb response to the vaccine.

o Once the response is confirmed, there is no further need to perform monthly HBsAg tests.

o If, during future annual HBsAb testing, it is determined that the SRUs drop below 10 or the result by EIA is negative, a booster dose of hepatitis B vaccine should be given.

o Monthly HBsAg can resume while awaiting the antibody response to this booster.

o Once the antibody titer confirms protection, no further HBsAg testing would be necessary.

Coding Information

 

Bill Type Codes

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

 

12x Hospital Inpatient (Medicare Part B only)

13x Hospital Outpatient

14x Hospital - Laboratory Services Provided to Non-patients

21x Skilled Nursing - Inpatient (Including Medicare Part A)

22x Skilled Nursing - Inpatient (Medicare Part B only)

23x Skilled Nursing - Outpatient

72x Clinic - Hospital Based or Independent Renal Dialysis Center

85x Critical Access Hospital

 

Revenue Codes

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

 

0302 Laboratory - Immunology

0306 Laboratory - Bacteriology & Microbiology

 

 

CPT/HCPCS Codes

 

86706 HEPATITIS B SURFACE ANTIBODY (HBSAB)

87340 INFECTIOUS AGENT ANTIGEN DETECTION BY ENZYME IMMUNOASSAY TECHNIQUE, QUALITATIVE OR SEMIQUANTITATIVE, MULTIPLE-STEP METHOD; HEPATITIS B SURFACE ANTIGEN (HBSAG)

 

 

ICD-9 Codes that Support Medical Necessity

 

 

For procedure code 86706 (Hepatitis B surface antibody)

 

 

070.20 VIRAL HEPATITIS B WITH HEPATIC COMA ACUTE OR UNSPECIFIED WITHOUT HEPATITIS DELTA

070.21 VIRAL HEPATITIS B WITH HEPATIC COMA ACUTE OR UNSPECIFIED WITH HEPATITIS DELTA

070.22 CHRONIC VIRAL HEPATITIS B WITH HEPATIC COMA WITHOUT HEPATITIS DELTA

070.23 CHRONIC VIRAL HEPATITIS B WITH HEPATIC COMA WITH HEPATITIS DELTA

070.30 VIRAL HEPATITIS B WITHOUT HEPATIC COMA ACUTE OR UNSPECIFIED WITHOUT HEPATITIS DELTA

070.31 VIRAL HEPATITIS B WITHOUT HEPATIC COMA ACUTE OR UNSPECIFIED WITH HEPATITIS DELTA

070.32 CHRONIC VIRAL HEPATITIS B WITHOUT HEPATIC COMA WITHOUT HEPATITIS DELTA

070.33 CHRONIC VIRAL HEPATITIS B WITHOUT HEPATIC COMA WITH HEPATITIS DELTA

403.01 HYPERTENSIVE CHRONIC KIDNEY DISEASE, MALIGNANT, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

403.11 HYPERTENSIVE CHRONIC KIDNEY DISEASE, BENIGN, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.02 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.03 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.12 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.13 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

585.4 CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE)

585.5 CHRONIC KIDNEY DISEASE, STAGE V

585.6 END STAGE RENAL DISEASE

V01.71 CONTACT OR EXPOSURE TO VARICELLA

V01.79 CONTACT OR EXPOSURE TO OTHER VIRAL DISEASES

V05.3 NEED FOR PROPHYLACTIC VACCINATION AND INOCULATION AGAINST VIRALHEPATITIS

V45.11* RENAL DIALYSIS STATUS

V67.59 OTHER FOLLOW-UP EXAMINATION

 

For procedure code 87340 (Hepatitis B surface antigen)

 

 

070.20 VIRAL HEPATITIS B WITH HEPATIC COMA ACUTE OR UNSPECIFIED WITHOUT HEPATITIS DELTA

070.21 VIRAL HEPATITIS B WITH HEPATIC COMA ACUTE OR UNSPECIFIED WITH HEPATITIS DELTA

070.22 CHRONIC VIRAL HEPATITIS B WITH HEPATIC COMA WITHOUT HEPATITIS DELTA

070.23 CHRONIC VIRAL HEPATITIS B WITH HEPATIC COMA WITH HEPATITIS DELTA

070.30 VIRAL HEPATITIS B WITHOUT HEPATIC COMA ACUTE OR UNSPECIFIED WITHOUT HEPATITIS DELTA

070.31 VIRAL HEPATITIS B WITHOUT HEPATIC COMA ACUTE OR UNSPECIFIED WITH HEPATITIS DELTA

070.32 CHRONIC VIRAL HEPATITIS B WITHOUT HEPATIC COMA WITHOUT HEPATITIS DELTA

070.33 CHRONIC VIRAL HEPATITIS B WITHOUT HEPATIC COMA WITH HEPATITIS DELTA

070.6 UNSPECIFIED VIRAL HEPATITIS WITH HEPATIC COMA

070.9 UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA

403.01 HYPERTENSIVE CHRONIC KIDNEY DISEASE, MALIGNANT, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

403.11 HYPERTENSIVE CHRONIC KIDNEY DISEASE, BENIGN, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.02 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.03 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.12 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.13 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

446.0 POLYARTERITIS NODOSA

570 ACUTE AND SUBACUTE NECROSIS OF LIVER

573.1 HEPATITIS IN VIRAL DISEASES CLASSIFIED ELSEWHERE

573.2 HEPATITIS IN OTHER INFECTIOUS DISEASES CLASSIFIED ELSEWHERE

573.3 HEPATITIS UNSPECIFIED

585.4 CHRONIC KIDNEY DISEASE, STAGE IV (SEVERE)

585.5 CHRONIC KIDNEY DISEASE, STAGE V

585.6 END STAGE RENAL DISEASE

719.40 PAIN IN JOINT SITE UNSPECIFIED

719.41 PAIN IN JOINT INVOLVING SHOULDER REGION

719.42 PAIN IN JOINT INVOLVING UPPER ARM

719.43 PAIN IN JOINT INVOLVING FOREARM

719.44 PAIN IN JOINT INVOLVING HAND

719.45 PAIN IN JOINT INVOLVING PELVIC REGION AND THIGH

719.46 PAIN IN JOINT INVOLVING LOWER LEG

719.47 PAIN IN JOINT INVOLVING ANKLE AND FOOT

719.48 PAIN IN JOINT INVOLVING OTHER SPECIFIED SITES

719.49 PAIN IN JOINT INVOLVING MULTIPLE SITES

729.1 MYALGIA AND MYOSITIS UNSPECIFIED

774.4 PERINATAL JAUNDICE DUE TO HEPATOCELLULAR DAMAGE

780.60 FEVER, UNSPECIFIED

780.61 FEVER PRESENTING WITH CONDITIONS CLASSIFIED ELSEWHERE

780.63 POSTVACCINATION FEVER

780.66 FEBRILE NONHEMOLYTIC TRANSFUSION REACTION

780.79 OTHER MALAISE AND FATIGUE

782.1 RASH AND OTHER NONSPECIFIC SKIN ERUPTION

782.4 JAUNDICE UNSPECIFIED NOT OF NEWBORN

783.0 ANOREXIA

787.02 NAUSEA ALONE

789.1 HEPATOMEGALY

790.4 NONSPECIFIC ELEVATION OF LEVELS OF TRANSAMINASE OR LACTIC ACID DEHYDROGENASE (LDH)

791.9 OTHER NONSPECIFIC FINDINGS ON EXAMINATION OF URINE

792.1 NONSPECIFIC ABNORMAL FINDINGS IN STOOL CONTENTS

V01.71 CONTACT OR EXPOSURE TO VARICELLA

V01.79 CONTACT OR EXPOSURE TO OTHER VIRAL DISEASES

V02.61 CARRIER OR SUSPECTED CARRIER OF HEPATITIS B

V45.11* RENAL DIALYSIS STATUS

Note: Billing for Hepatitis B Surface Antigen for ESRD beneficiaries requires dual diagnoses. Please submit codes 403.01, 403.11, 404.02, 404.03, 404.12, 404.13, or 585.4-585.6 and *V45.11 to report the approved indication.

* According to the ICD-9-CM book, Diagnosis code V45.11 is a secondary diagnosis code and should not be billed as the primary diagnosis.

 

 

Documentation Requirements

• For someone suspected of having been recently exposed to the hepatitis B virus, the medical record documentation must contain information regarding the beneficiary’s vaccination status, and the suspected incident including an assessment of current signs and symptoms.

o It is expected that the initial and, if needed, subsequent hepatitis B lab test results (e.g., HBsAg, HBsAb, and/or Anti-HBc-IgM) be contained within the medical record.

o This information is usually found in the history and physical, office notes, test results, and/or progress notes.

• Medical record documentation for ESRD beneficiaries receiving services through Medicare dialysis facilities must contain information regarding the method of dialysis, their hepatitis B vaccination status and the results of their initial admission serology testing and all subsequent hepatitis B surface antigen and antibody tests.

• If the provider of service is other than the ordering/referring physician, that provider must maintain hard copy documentation of test results and interpretation, along with copies of the ordering/referring physician’s order for the test(s).

o The physician must state the beneficiary’s vaccination status as well as the clinical indication/medical necessity for the study in his order for the test(s).

 

Treatment Logic

• Hepatitis B surface antigen (HBsAg) is the earliest indicator of an acute hepatitis B infection.

o It can be detected one to seven weeks before liver enzyme elevation or the onset of clinical symptoms. The serology of 50% of affected patients will be positive three weeks after acute onset, while at the seventeen week mark only 10% will remain positive.

o There is evidence of a “window” stage where the hepatitis B surface antigen has become negative and the patient has not yet developed the hepatitis B surface antibody.

o The chronic carrier state is indicated by the persistence of hepatitis B surface antigen over six months and longer (even years) while never seroconverting to hepatitis B surface antibody.

o The reference range is negative.

o The detection of the hepatitis B surface antigen establishes the presence of infection and implies infectivity.

• Hepatitis B surface antibody (HbsAb or anti-HBs) is present in the serum of patients who have resolved a previous hepatitis B infection or have been vaccinated against hepatitis B.

o The disappearance of hepatitis B antigen with the appearance of hepatitis B antibody signals recovery from the hepatitis B infection, the status of noninfectivity and protection from recurrent hepatitis B infection.

o Hepatitis B surface antibody can be detected several weeks to several years after Hepatitis B antigen can no longer be detected.

o It may persist for life after the acute infection has been resolved.

o Since there are different serologic subtypes of the hepatitis B virus, it is possible for a patient to have an antibody for one subtype and be infected with another.

o Transfused individuals or hemophiliacs receiving plasma components may have false positive tests.

o Individuals vaccinated with HBV vaccine will have antibodies.

o The appearance of the hepatitis B antibody following vaccination signals successful vaccination against hepatitis B.

o The detection of hepatitis B surface antibody in the patient’s serum can be performed by either the radioimmunoassay (RIA) or enzyme immunoassay (EIA) method.

o The reference range varies with the clinical circumstance.

 

 

Sources of Information and Basis for Decision

 

Adhami, T., Levinthal, G. (2002). Hepatitis B. Retrieved August 3, 2005, from http://www.clevelandclinicmeded.com/diseasemanagement/gastro/hepatitis_b/hepatitis_b.htm.

 

Anderson, D.M., (2002). Mosby’s Medical Dictionary (6th ed.). St. Louis: Mosby.

 

Cohen, J.; Powderly, W. (2004). Hepatitis B Virus. Infectious Diseases, 2nd ed., (pp. 2011-2016). St. Louis: Mosby.

 

FCSO LCD 29189, Hepatitis B Surface Antibody and Surface Antigen, 10/01/2010. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Nissl, J. (2004, November). Hepatitis B Virus Test. Retrieved August 2, 2005, from http://my.webmd.com/hw/hepatitis/hw201572.asp.

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

 CMS LCD L28852 HEPATITIS B SURFACE ANTIBODY AND SURFACE ANTIGEN