LCD : Hepatitis B (Serologic Testing) (L1641)

LCD for Hepatitis B (Serologic Testing) (L1641)

Contractor Information

Contractor Name

BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator)

Contractor Number

00390

Contractor Type

LCD Information

LCD ID Number

L1641

LCD Title

Hepatitis B (Serologic Testing)

Contractor's Determination Number

1641

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2007 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy

Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). This section excludes coverage of items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, Section 1862 (a)(7). This section prohibits Medicare payment for any expenses on items and services incurred for routine physical examinations.

Title XVIII of the Social Security Act, Section 1833 (e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.

Addendum B (National Coverage Decision for Hepatitis Panel) of Clinical Diagnostic Laboratory Tests

Primary Geographic Jurisdiction

New Jersey
Tennessee

Secondary Geographic Jurisdiction

Alaska
Alabama
Arkansas
Arizona
California
Colorado
Connecticut
Florida
Georgia
Hawaii
Iowa
Idaho
Illinois
Indiana
Kansas
Kentucky
Louisiana
Massachusetts
Maryland
Maine
Michigan
Minnesota
Missouri
Mississippi
North Carolina
North Dakota
Nebraska
New Jersey
New Mexico
Nevada
New York
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Virginia
Vermont
Washington
Wisconsin
West Virginia
Wyoming

Oversight Region

Region IV

Original Determination Effective Date

For services performed on or after 07/22/1995

Original Determination Ending Date

Revision Effective Date

For services performed on or after 02/08/2006

Revision Ending Date

Indications and Limitations of Coverage and/or Medical Necessity

Hepatitis B (ICD-9 070.3) is an inflammation of the liver caused by a virus. Hepatitis B virus (HBV) contains Hepatitis B surface antigen (HBAg) which can be detected in the blood of a HBV infected person by serologic testing. Additionally, Hepatitis B core antibody (HBcAb), Hepatitis B surface antibody (HBsAb) and Hepatitis B-e antibody (HBeAb) are also antibodies to Hepatitis B antigens that can be detected by serologic testing.

Routine screening of all patients for HBV is not considered reasonable and necessary and is non-covered. Screening for HBV without symptoms documented may be reasonable (e.g. in a person with high risk sexual activities) but would still be non covered due to the exclusion of routine screening. (Social Security Act 1862 (A) (a) (7) Testing after actual exposure is reasonable and necessary and should be filed with the appropriate V01 code.

Antigen and/or antibody testing to diagnose/rule out HBV is considered reasonable and necessary when performed on patients considered symptomatic, i.e., present with two or more of the following symptoms:

jaundice (782.4)
anorexia (783.0)
nausea and vomiting (787.01-787.02)
right upper quadrant abdominal pain (789.01)
hepatomegaly (789.1)
abnormal liver function tests (794.8)
positive test results (V02.60-V02.69)

Patient undergoing renal dialysis need to be tested for Hepatitis B Surface Antigen and Antibody status. If both tests are negative, the patient should be given Hepatitis B vaccine. One (1) month after the last dose of vaccine, the patient should have a Hepatitis B Surface Antibody test. If the antibody test is positive (antibody detected) then no further surface antigen tests are necessary and the antibody test should be repeated yearly to confirm continued immunity. If the surface antibody test is negative (no antibody detected) after the vaccination, the patient should be revaccinated with a higher dose of vaccine and the antibody level retested. If the antibody test remains negative after the second vaccination or the patient refuses to be vaccinated, then a monthly surface antigen test should be done to determine the patient’s Hepatitis B infection status.

Therefore, Hepatitis B testing in the setting of Renal Dialysis is not medically necessary (and thus not indicated or covered) beyond the following:

1. One (1) Hepatitis B Surface Antigen and antibody (or Hepatitis panel) test per renal dialysis patient initially (usually preceding vaccination)

2. One (1) month after the last dose of vaccine, a repeat Hepatitis B Surface Antibody test is medically necessary. If the surface antibody test is negative (no antibody detected) after the vaccination and the patient is re-vaccinated with a higher dose of vaccine antibody level re-testing is appropriate.

3. If the antibody test remains negative after the second vaccination or the patient refuses to be vaccinated, then a monthly surface antigen test to determine the patient's Hepatitis B infection status may be medically indicated. (Documentation, including a signed patient refusal, may be required.)

4. Once adequate antibody levels have been established following immunization, no further surface antigen tests are necessary and the antibody test should be repeated yearly to confirm continued immunity.

5. The use of hepatitis B testing to follow confirmed disease is not considered routine screening.

Coverage Topic

Lab Services

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 or home health visits (Part B only)
13x	Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)
14x	Non-Patient Laboratory Specimens
15x	Hospital-intermediate care - level I
16x	Hospital-intermediate care - level II
17x	Hospital-intermediate care - level III
18x	Hospital-swing beds
19x	Hospital-reserved for national assignment
21x	SNF-inpatient, Part A
22x	SNF-inpatient or home health visits (Part B only)
23x	SNF-outpatient (HHA-A also)
24x	SNF-other (Part B)
25x	SNF-intermediate care - level I
26x	SNF-intermediate care - level II
27x	SNF-intermediate care - level III
28x	SNF-swing beds
29x	SNF-reserved for national assignment
31x	HHA-inpatient (including Part A)
32x	HHA-inpatient or home health visits (Part B only)
33x	HHA-outpatient (HHA-A also)
34x	HHA-other (Part B)
35x	HHA-intermediate care - level I
36x	HHA-intermediate care - level II
37x	HHA-intermediate care - level III
38x	HHA-swing beds
39x	HHA-reserved for national assignment
41x	Religious Nonmedical Health Care Institution (RNHCI) hospital-inpatient (including Part A) (all references to Christian Science (CS) is obsolete eff. 8/00 and replaced with RNHCI)
42x	RNHCI hospital-inpatient or home health visits (Part B only)
43x	RNHCI hospital-outpatient (HHA-A also)
44x	RNHCI hospital-other (Part B)
45x	RNHCI hospital-intermediate care - level I
46x	RNHCI hospital-intermediate care - level II
47x	RNHCI hospital-intermediate care - level III
48x	RNHCI hospital-swing beds
49x	RNHCI hospital-reserved for national assignment
51x	CS extended care-inpatient (including Part A) OBSOLETE eff. 7/00 - implementation of Religious Nonmedical Health Care Institutions (RNHCI)
52x	RNHCI extended care-inpatient or home health visits (Part B only) (eff. 7/00); prior to 7/00 Christian Science (CS)
53x	RNHCI extended care-outpatient (HHA-A also) (eff. 7/00); prior to 7/00 referenced CS
54x	RNHCI extended care-other (Part B)(eff. 7/00); prior to 7/00 referenced CS
55x	RNHCI extended care-intermediate care - level I (eff. 7/00) prior to 7/00 referenced CS
56x	RNHCI extended care-intermediate care - level II (eff. 7/00) prior to 7/00 referenced CS
57x	RNHCI extended care-intermediate care - level III (eff. 7/00) prior to 7/00 referenced CS
58x	RNHCI extended care-swing beds (eff. 7/00) prior to 7/00 referenced CS
59x	RNHCI extended care-reserved for national assignment (eff. 7/00); prior to 7/00 referenced CS
61x	Intermediate care-inpatient (including Part A)
62x	Intermediate care-inpatient or home health visits (Part B only)
63x	Intermediate care-outpatient (HHA-A also)
64x	Intermediate care-other (Part B)
65x	Intermediate care-intermediate care - level I
66x	Intermediate care-intermediate care - level II
67x	Intermediate care-intermediate care - level III
68x	Intermediate care-swing beds
69x	Intermediate care-reserved for national assignment
71x	Clinic-rural health
72x	Clinic-hospital based or independent renal dialysis facility

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

CPT/HCPCS Codes

86704	HEPATITIS B CORE ANTIBODY (HBCAB); TOTAL
86706	HEPATITIS B SURFACE ANTIBODY (HBSAB)
86707	HEPATITIS BE ANTIBODY (HBEAB)
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

070.0 - 070.9	VIRAL HEPATITIS A WITH HEPATIC COMA - UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA
456.0 - 456.21	ESOPHAGEAL VARICES WITH BLEEDING - ESOPHAGEAL VARICES IN DISEASES CLASSIFIED ELSEWHERE WITHOUT BLEEDING
570	ACUTE AND SUBACUTE NECROSIS OF LIVER
571.1	ACUTE ALCOHOLIC HEPATITIS
572.0 - 572.8	ABSCESS OF LIVER - OTHER SEQUELAE OF CHRONIC LIVER DISEASE
573.3	HEPATITIS UNSPECIFIED
780.31	FEBRILE CONVULSIONS (SIMPLE), UNSPECIFIED
780.71	CHRONIC FATIGUE SYNDROME
780.79	OTHER MALAISE AND FATIGUE
782.4	JAUNDICE UNSPECIFIED NOT OF NEWBORN
783.0	ANOREXIA
784.69	OTHER SYMBOLIC DYSFUNCTION
787.01	NAUSEA WITH VOMITING
789.00 - 789.09	ABDOMINAL PAIN UNSPECIFIED SITE - ABDOMINAL PAIN OTHER SPECIFIED SITE
789.1	HEPATOMEGALY
789.60 - 789.69	ABDOMINAL TENDERNESS UNSPECIFIED SITE - ABDOMINAL TENDERNESS OTHER SPECIFIED SITE
794.8	NONSPECIFIC ABNORMAL RESULTS OF FUNCTION STUDY OF LIVER
998.81	EMPHYSEMA (SUBCUTANEOUS) (SURGICAL) RESULTING FROM PROCEDURE
999.31	INFECTION DUET CENTRAL VENOUS CATHETER
999.39	INFECTION FOLLOWING OTHER INFUSION, INJECTION, TRANSFUSION, OR VACCINATION
V02.60	CARRIER OR SUSPECTED CARRIER OF VIRAL HEPATITIS UNSPECIFIED
V02.61	CARRIER OR SUSPECTED CARRIER OF HEPATITIS B

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

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

Diagnoses that DO NOT Support Medical Necessity

General Information

Documentation Requirements

History and Physical (medical justification for testing)

Physician's orders

Laboratory test results

Detailed itemization of charges

Appendices

Utilization Guidelines

Sources of Information and Basis for Decision

Other contractor policy

Advisory Committee Meeting Notes

Start Date of Comment Period

04/13/1995

End Date of Comment Period

Start Date of Notice Period

06/22/1995

Revision History Number

1641a

Revision History Explanation

10/01/2004 Code Updated

12/10/2003 Converted to LCD

01/13/2003 Added 12x to Typed of Bill Code

07/24/2002 Formatted

02/07/2001 updated ICD-9 and CPT 2001 codes. Updated Indications and Limitations of Coverage

This LCD was converted from an LMRP on 12/9/2003

7/2/2006 - The description for Bill code 14 was changed

09/04/2006 - This policy was updated by the ICD-9 2006-2007 Annual Update.

11/18/2006 - The description for CPT/HCPCS code 87340 was changed in group 1
1/5/07 Update contractor's determination number to reflect L1641

09/03/2007 - This policy was updated by the ICD-9 2007-2008 Annual Update.

2/18/2008 - The description for Bill code 21 was changed

3/20/2008 - Reviewed 2008 Bill type code update