L28852-LCD

Automated World Health

Local Coverage Determination (LCD) for Hepatitis B Surface Antibody and Surface Antigen (L28852)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L28852

LCD Title

Hepatitis B Surface Antibody and Surface Antigen

Contractor's Determination Number A86706

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/16/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2010

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 11, Sections 30.2.1-30.4

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Part 3, Section

190.10

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, Sections 10; 10.2; 90.1 and

90.2

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, Section 40 CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.1.3

Indications and Limitations of Coverage and/or Medical Necessity

Hepatitis B surface antigen (HBsAg) is the earliest indicator of an acute hepatitis B infection. 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. 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. 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. The reference range is negative. 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. 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. Hepatitis B surface antibody can be detected

several weeks to several years after Hepatitis B antigen can no longer be detected. It may persist for life after the acute infection has been resolved. 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. Transfused individuals or hemophiliacs receiving plasma components may have false positive tests. Individuals vaccinated with HBV

vaccine will have antibodies. The appearance of the hepatitis B antibody following vaccination signals successful vaccination against hepatitis B. 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. The reference range varies with the clinical circumstance.

HEPATITIS B SURFACE ANTIBODY

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

I. 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.

II. 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.

III. 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.

IV. 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.

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

2. 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.

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.

V. 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. Between one and six months following the final vaccine dose, all patients should be tested for HBsAb response to the vaccine. Once the response is confirmed as positive, there is no further need to perform semiannual HBsAb tests. 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. 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:

I. 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.

II. 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).

III. 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)

IV. 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 as well as the vaccination status. 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. Between one and six months following the final vaccine dose, all patients should be tested for HBsAb response to the vaccine. Once the response is confirmed, there is no further need to perform monthly HBsAg tests. 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. Monthly HBsAg can resume while awaiting the antibody response to this booster. 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.

012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient

014x Hospital - Laboratory Services Provided to Non-patients 021x Skilled Nursing - Inpatient (Including Medicare Part A) 022x Skilled Nursing - Inpatient (Medicare Part B only) 023x Skilled Nursing - Outpatient

072x Clinic - Hospital Based or Independent Renal Dialysis Center 085x 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 - 070.23

070.30 - 070.33

VIRAL HEPATITIS B WITH HEPATIC COMA ACUTE OR UNSPECIFIED WITHOUT HEPATITIS DELTA - CHRONIC VIRAL HEPATITIS B WITH HEPATIC COMA WITH HEPATITIS DELTA

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

HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART

404.03

404.12

FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

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 - V01.79

CONTACT OR EXPOSURE TO VARICELLA - 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

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.

Note: Renal dialysis facilities (72x) should report a diagnosis code of 585.6 for submission of claims. For procedure code 87340 (Hepatitis B surface antigen):

070.20 - 070.23

070.30 - 070.33

VIRAL HEPATITIS B WITH HEPATIC COMA ACUTE OR UNSPECIFIED WITHOUT HEPATITIS DELTA - CHRONIC VIRAL HEPATITIS B WITH HEPATIC COMA WITH HEPATITIS DELTA

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

HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART

404.02

404.03

404.12

FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

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

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

PAIN IN JOINT SITE UNSPECIFIED - PAIN IN JOINT INVOLVING MULTIPLE SITES

719.40 - 719.49

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 - V01.79

CONTACT OR EXPOSURE TO VARICELLA - CONTACT OR EXPOSURE TO OTHER VIRAL DISEASES

V02.61 CARRIER OR SUSPECTED CARRIER OF HEPATITIS B

V45.11* RENAL DIALYSIS STATUS

* 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.

Note: Renal dialysis facilities (72x) should report a diagnosis code of 585.6 for submission of claims.

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations 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. 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. 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). 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).

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated in the “Indications and Limitations of Coverage and/or Medical Necissity” section of this policy. When services are performed in excess of

established parameters, they may be subject to review for medical necessity.

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.

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

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from the Florida Gastroenterologic Society, Florida Society of Nephrology and the Clinical Laboratory Management Association.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 10/01/2010

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2010 Revised Effective Date:10/01/2010

LCR A2010-050

September 2010 Bulletin

Explanation of Revision: Annual 2011 ICD-9-CM Update. Added diagnosis code 780.66 and descriptor for CPT code 87340. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/16/2009

LCR A2009-034FL

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the fiscal intermediary predecessors of First Coast Service Options, Inc. (COSVI and FCSO).

For Florida (00090) this LCD (L28852) replaces LCD L1334 as the policy in notice. This document (L28852) is effective on 02/16/2009.

8/1/2010 - The description for Bill Type Code 12 was changed 8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 14 was changed 8/1/2010 - The description for Bill Type Code 21 was changed 8/1/2010 - The description for Bill Type Code 22 was changed 8/1/2010 - The description for Bill Type Code 23 was changed 8/1/2010 - The description for Bill Type Code 72 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0302 was changed 8/1/2010 - The description for Revenue code 0306 was changed

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

87340 descriptor was changed in Group 1

Reason for Change