Local Coverage Determination (LCD)

Hepatic (Liver) Function Panel

L33907

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33907
Original ICD-9 LCD ID
Not Applicable
LCD Title
Hepatic (Liver) Function Panel
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 09/07/2021
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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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.

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Issue

Issue Description

Section 50.1 in the Internet-Only Manual 100-04, Chapter 8 was revised with CR 12079 to 50.1.1

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Hepatic (Liver) Function Panel. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Hepatic (Liver) Function Panel and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site. 

Internet Only Manual (IOM) Citations:  

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 11, Section 20 Renal Dialysis Items and Services, Section 20.2 Laboratory Services, Section 30.1 Home Dialysis Items and Services, Section 30.2 Home Dialysis Training, Section 40 G. Renal Dialysis Services Furnished During the Creation or Revision of a Vascular Access, and Section 100.5 Renal Dialysis Services Included in the AKI Payment Rate
    • Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
    • Chapter 1, Part 3, Section 190.10 Laboratory Tests - CRD Patients 
  • CMS IOM Publication 100-04, Medicare Claims Processing Manual,
    • Chapter 8, Section 50.1 Laboratory Services Included in the End Stage Renal Disease Prospective Payment System ESRD PPS,  Section 60 Separately Billable ESRD Items and Services, and Section 60.1 Lab Services
    • Chapter 16 Laboratory Services
    • Chapter 23, Section 40 Clinical Diagnostic Laboratory Fee Schedule 
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD 

Social Security Act (Title XVIII) Standard References:  

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 

Federal Register References:

  • CFR, Title 42, Volume 2, Chapter IV, Part 410.32(d)(3)  Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

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. 
 
Covered Indications

A hepatic function panel will be considered 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

The following are considered not medically reasonable and necesary:

  • 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 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.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

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N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

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Additional ICD-10 Information

General Information

Associated Information

Please refer to the related Local Coverage Article: Billing and Coding: Hepatic (Liver) Function Panel, A57802 for documentation requirements, utilization parameters and all coding information as applicable.

Sources of Information

First Coast Service Options, Inc. reference LCD number – L29435

Detailed View: Safety labeling changes approved by FDA Center for Drug Evaluation and Research (CDER)(2003). 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. 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. 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. This source was used to review methods recommended for determining drug dosage and monitoring for patients with impaired hepatic function.

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
09/07/2021 R3

LCD revised and published on 11/11/2021 to revise the title of Section 50.1 in the Internet-Only Manual 100-04, Chapter 8 was revised with CR 12079 to 50.1.1. The reference in the LCD has been updated with this revision. Minor formatting changes have been made throughout the LCD.

  • Other (Revision based on CR 12079)
01/08/2019 R2

Revision Number : 2
Publication: November 2019 Connection
LCR B2019-031

Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes,” “Revenue Codes,” “CPT/HCPCS Codes,” “ICD-10 Codes that Support Medical Necessity,” “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. In addition, during the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. Also, the Social Security Act, Code of Federal Regulations and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Other (Revision based on CR 10901)
10/01/2018 R1

Revision Number: 1
Publication: September 2018 Connection
LCR B2018-017

Explanation of Revision: Based on CR 10847 (Annual 2019 ICD-10-CM Update) the LCD was revised. Added ICD-10-CM diagnosis code Z20.821. Revised descriptor for ICD-10-CM diagnosis code Z77.29. In addition, the LCD was revised to indicate that diagnosis codes were added and deleted within existing diagnosis code ranges. The effective date of this revision is based on date of service.

10/01/2018:  At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Revisions Due To ICD-10-CM Code Changes
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Associated Documents

Attachments
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Related Local Coverage Documents
Articles
A57802 - Billing and Coding: Hepatic (Liver) Function Panel
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
11/05/2021 09/07/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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