L29188-LCD

Automated World Health

Local Coverage Determination (LCD) for Hepatic (Liver) Function Panel (L29188)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29188

LCD Title Hepatic (Liver) Function Panel

Contractor's Determination Number 80076

Primary Geographic Jurisdiction opens in new window 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 02/02/2009

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/12/2010

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. 100-04, Medicare Claims Processing, Chapter 16, Sections 10, 10.2, 90.1, 90.1.1, 90.2

Indications and Limitations of Coverage and/or Medical Necessity

Hepatic (liver) function can be measured in terms of serum enzyme activity such as alkaline phosphatase, transaminases, lactic dehydrogenase and serum concentrations of proteins, bilirubin, ammonia, clotting factors and lipids. Several of these tests may be helpful for the assessment and management of individuals with hepatic (liver) disease or injury and for monitoring the effects of medications and toxic material on liver function.

The hepatic (liver) function panel consists of Albumin, serum; Bilirubin, total; Bilirubin, direct; alkaline phosphatase; transferase, alanine amino (ALT) (SGPT), transferase, aspartate amino (ALT) (SGOT); and protein, total.

Indications

Medicare will consider a hepatic function panel medically necessary when performed for the following clinically indicated conditions:

• Signs and symptoms of liver disease (e.g., jaundice, nausea accompanied with vomiting and/or weight loss, bright yellow urine, grey or pale colored stools, change of sleep patterns, vomiting of blood or the passing of blood in the stools, tiredness or loss of stamina, abdominal swelling caused by: an enlarged liver or an enlarged spleen or excess fluid in the abdomen [ascities], pain associated with the abdomen, increased water consumption and urination, progressive depression or lethargy);

• Hematologic disturbances which are commonly associated with liver disease (e.g., coagulation disorders, anemia, thrombocytopenia);

• History of exposure to environmental toxins which may result in hepatotoxicity;

• Patients under treatment with medications suspected or known to produce hepatotoxic effects. Commonly, instructions for use of such medications include manufacturer recommendations that frequent monitoring of liver function be performed while under treatment;

• An abnormal value of any of the components of the panel; and/or

• A history of exposure to hepatitis. Limitations

• Tests performed during annual physical examinations or other routine screening situations without signs, symptoms or illnesses which indicate medical necessity will result in denial as a non-covered benefit.

• Payment is made only for those tests in an automated profile that meet Medicare coverage rules. Where only some of the tests in a profile of tests are covered, payment cannot exceed the amount that would have paid if only the covered tests had been ordered.

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.

999x Not Applicable

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.

99999 Not Applicable

CPT/HCPCS Codes

80076 HEPATIC FUNCTION PANEL

ICD-9 Codes that Support Medical Necessity

042 HUMAN IMMUNODEFICIENCY VIRUS (HIV) DISEASE

070.0 - 070.9 opens in new window

VIRAL HEPATITIS A WITH HEPATIC COMA - UNSPECIFIED VIRAL HEPATITIS WITHOUT HEPATIC COMA

130.5 HEPATITIS DUE TO TOXOPLASMOSIS

151.0 - 151.9 opens in new window

152.0 - 152.9 opens in new window

153.0 - 153.9 opens in new window

154.0 - 154.8 opens in new window

155.0 - 155.2 opens in new window

156.0 - 156.9 opens in new window

157.0 - 157.9 opens in new window

162.0 - 162.9 opens in new window

172.0 - 172.9

MALIGNANT NEOPLASM OF CARDIA - MALIGNANT NEOPLASM OF STOMACH UNSPECIFIED SITE

MALIGNANT NEOPLASM OF DUODENUM - MALIGNANT NEOPLASM OF SMALL INTESTINE UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

MALIGNANT NEOPLASM OF LIVER PRIMARY - MALIGNANT NEOPLASM OF LIVER NOT SPECIFIED AS PRIMARY OR SECONDARY

MALIGNANT NEOPLASM OF GALLBLADDER - MALIGNANT NEOPLASM OF BILIARY TRACT PART UNSPECIFIED SITE

MALIGNANT NEOPLASM OF HEAD OF PANCREAS - MALIGNANT NEOPLASM OF PANCREAS PART UNSPECIFIED

MALIGNANT NEOPLASM OF TRACHEA - MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

MALIGNANT MELANOMA OF SKIN OF LIP - MELANOMA OF SKIN SITE UNSPECIFIED

174.0 - 174.9 opens in new window

175.0 - 175.9 opens in new window

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY

277.4 DISORDERS OF BILIRUBIN EXCRETION

286.9 OTHER AND UNSPECIFIED COAGULATION DEFECTS

287.5 THROMBOCYTOPENIA UNSPECIFIED

571.0 - 571.9 opens in new window ALCOHOLIC FATTY LIVER - UNSPECIFIED CHRONIC LIVER DISEASE WITHOUT ALCOHOL

572.0 - 572.8 opens in new window ABSCESS OF LIVER - OTHER SEQUELAE OF CHRONIC LIVER DISEASE

573.0 - 573.9 opens in new window CHRONIC PASSIVE CONGESTION OF LIVER - UNSPECIFIED DISORDER OF LIVER

574.00 - 574.91 opens In new window

575.0 - 575.9 opens in new window CALCULUS OF GALLBLADDER WITH ACUTE CHOLECYSTITIS WITHOUT OBSTRUCTION - CALCULUS OF GALLBLADDER AND BILE DUCT WITHOUT CHOLECYSTITIS WITH OBSTRUCTION ACUTE CHOLECYSTITIS - UNSPECIFIED DISORDER OF GALLBLADDER

576.0 - 576.9 opens in new window POSTCHOLECYSTECTOMY SYNDROME - UNSPECIFIED DISORDER OF BILIARY TRACT

578.1 HEMATEMESIS

578.2 BLOOD IN STOOL

780.79 OTHER MALAISE AND FATIGUE

782.4 JAUNDICE UNSPECIFIED NOT OF NEWBORN

789.01 ABDOMINAL PAIN RIGHT UPPER QUADRANT

789.5 ABDOMINAL PAIN PERIUMBILIC

789.6 ABDOMINAL PAIN EPIGASTRIC

789.1 HEPATOMEGALY

789.2 SPLENOMEGALY

789.59 OTHER ASCITES

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

790.5 OTHER NONSPECIFIC ABNORMAL SERUM ENZYME LEVELS

791.4 BILIURIA

794.8 NONSPECIFIC ABNORMAL RESULTS OF FUNCTION STUDY OF LIVER

995.0 OTHER ANAPHYLACTIC REACTION

V01.79 CONTACT OR EXPOSURE TO OTHER VIRAL DISEASES

V42.7* LIVER REPLACED BY TRANSPLANT

V58.11 ENCOUNTER FOR ANTINEOPLASTIC CHEMOTHERAPY

V58.69 LONG-TERM (CURRENT) USE OF OTHER MEDICATIONS

V67.51 FOLLOW-UP EXAMINATION FOLLOWING COMPLETED TREATMENT WITH HIGH-RISK MEDICATION NOT ELSEWHERE CLASSIFIED

V87.39 CONTACT WITH AND (SUSPECTED) EXPOSURE TO OTHER POTENTIALLY HAZARDOUS SUBSTANCES

*According to the ICD-9-CM book, diagnosis code V42.7 is a secondary diagnosis codes and should not be billed as the primary diagnosis.

Diagnoses that Support Medical Necessity n/a

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

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

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Documentation supporting the medical justification for components of the test billed must be contained in the patient’s medical records (e.g., office/progress notes). In addition, laboratory results of the tests ordered must be available upon request. If the provider of the service is other than the ordering/referring physician, the provider

of the service must maintain hard copy documentation of the test results and interpretation, along with copies of the ordering/referring physician’s order for the studies. The physician must state the clinical indication/medical necessity for each test billed.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. 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

Detailed View: Safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER)(2003). Retrieved from website on 08/20/2000. http://www.fda.gov/med watch/SAFETY/2003/feb03.htm This source was used to identify drugs which may have adverse effects on liver function.

Food and Drug Administration Working Group (2000) Nonclinical assessment of potential hepatotoxicity in man. Retrieved from internet Sept. 2003 www.phrma.org/meetings/news/2000-12-11.13pdf This source was used to identify causes of liver toxicity in man.

Mosbys Drug Consult (2003) Mosby, Inc This source was used to identify drugs with potential hepatotoxic effects.

The Merck Manual of Diagnosis & Therapy, Sec 4, Ch 38, Clinical features of liver disease. Retrieved from online manual on September 3, 2003 This source was used to define signs and symptoms of liver disease.

U.S. Dept of Health and Human Services (2003) Guidance for industry pharmacokinetics in patients with impaired hepatic function: study, design, data, analysis and impact on dosing and labeling. Retrieved from internet 08/20/2003 http://www.fda.gov/eber/gdlns/imphep.pdf. This source was used to review methods recommended for determining drug dosage and monitoring for patients with impaired hepatic function.

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 advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2010

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2011 Revised Effective Date: 10/01/2011

LCR B2011-101

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Revised descriptor for diagnosis code 995.0. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/12/2010

LCR B2009- 118

December 2009 Update

Explanation of Revision: Revision to add ICD-9-CM codes 286.9, 287.5, 578.0, 578.1, 780.79, 789.2, 789.59, 791.4, V01.79, and V87.39 to the “ICD-9 Codes that Support Medical Necessity” section of the LCD. 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:02/02/2009

LCR B2009-

December 2008 Bulletin

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

For Florida (00590) this LCD (L29188) replaces LCD L17706 as the policy in notice. This document (L29188) is effective on 02/02/2009.

08/08/2009 - This policy was updated by the ICD-9 2009-2010 Annual Update.

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

Reason for Change