SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests

A54262

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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Contractor Information

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General Information

Source Article ID
N/A
Article ID
A54262
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
10/24/2019
Revision Ending Date
11/15/2023
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Guidance

Article Text

Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant disorder with variable clinical presentation. Most common manifestations are epistaxis, recurrent gastrointestinal bleeding, iron deficiency anemia, and mucocutaneous telangectasias. Arteriovenous malformations (AVMs), of various organs (lung, liver, brain) are common.

The two most prevalent forms of HHT, Type 1 and Type 2, are caused by mutations in the endoglin (ENG) or the ACVRL1 gene respectively. Although identification of these gene mutations can confirm the diagnosis of HHT, these tests are not necessary in many cases. HHT is generally established using well vetted consensus criteria (most often the International Curaçao Criteria (ICC)). The ICC uses the clinical characteristics of epistaxis, cutaneous or mucosal telangectasias, visceral AVMs, and a first-degree relative with HHT to judge likelihood of a given patient having HHT. A 'definite' diagnosis is established when a patient has 3 or 4 of these criteria. Genetic testing for ENG/ACVRL1 is not warranted. A patient with 0 to 1 criteria is 'unlikely' to have HHT, and similarly would not be a candidate for genetic testing. Patients with 2 or 3 Curaçao criteria are defined as “suspected” of HHT and are candidates for ENG/ACVRL1 testing.

Since screening of patients without signs or symptoms of HHT, who have a first-degree relative with HHT, is not a Medicare benefit, CGS Administrators and the MolDX program contractor has determined ENG and/or ACVRL1 genetic testing and panels of tests that include ENG/ACVRL1 are statutorily excluded services.

EXCEPTIONS: For patients with “suspected” HHT in which diagnosis confirmation would demonstrate an improved outcome, approval will be made on a case-by-case basis through the appeal process.

For tests that include ENG and ACVRL1 registered and assigned a single MolDX ID, submit CPT® code 81479.

To receive an ENG and/or ACVRL1 gene test denial, please submit the following claim information:

  • Select appropriate CPT® code for test
    • 81405-ENG, Duplication/deletion
    • 81406-ENG, full gene sequence
    • 81479-ACVRL1
    • 81479-ACVRL1 and ENG
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services 
    • For a voluntary issued ABN, append with GX modifier 
    • To indicate a valid ABN is on file for a known statutorily excluded service, append with a GY modifier
  •  For CPT® non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
  • Enter the appropriate DEX Z-Code identifier adjacent to the CPT® code in the comment/narrative field for the
    following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Box 19 for paper claim
  • Enter the appropriate DEX Z-Code identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form








Response To Comments

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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
81405 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 6 (EG, ANALYSIS OF 6-10 EXONS BY DNA SEQUENCE ANALYSIS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 11-25 EXONS, REGIONALLY TARGETED CYTOGENOMIC ARRAY ANALYSIS)
81406 MOLECULAR PATHOLOGY PROCEDURE, LEVEL 7 (EG, ANALYSIS OF 11-25 EXONS BY DNA SEQUENCE ANALYSIS, MUTATION SCANNING OR DUPLICATION/DELETION VARIANTS OF 26-50 EXONS, CYTOGENOMIC ARRAY ANALYSIS FOR NEOPLASIA)
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
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CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

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Group 1 Codes
Code Description
GX NOTICE OF LIABILITY ISSUED, VOLUNTARY UNDER PAYER POLICY
GY ITEM OR SERVICE STATUTORILY EXCLUDED, DOES NOT MEET THE DEFINITION OF ANY MEDICARE BENEFIT OR, FOR NON-MEDICARE INSURERS, IS NOT A CONTRACT BENEFIT
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ICD-10-CM Codes that Support Medical Necessity

Group 1

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Group 1 Codes

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

Group 1

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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Group 1 Codes

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Additional ICD-10 Information

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

Code Description
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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 article, 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 article should be assumed to apply equally to all Revenue Codes.

Code Description
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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
10/24/2019 R12

Revision Effective date:10/24/2019
Revision Explanation: Removed guidelines from title. Under Article Text removed the bullet that reads “Select the appropriate diagnosis for the patient”, and removed the last paragraph. Under CPT/HCPCS Codes Group 1: Codes added CPT® codes 81405, 81406 and 81479. Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and GY. CPT® was inserted throughout the article where applicable.

10/03/2019 R11

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/03/2019 R10

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

01/01/2019 R9

Revision Effective date: 01/01/2019
Revision Explanation: Removed code 81403 from article and added all codes in CPT/HCPCS section.

04/27/2017 R8

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

04/27/2017 R7

Revision Effective date: N/A
Revision Explanation: Corrected the bullet formatting in the text.

 

10/01/2015 R6

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

04/27/2017 R5 Revision Effective date: 04/27/2017
Revision Explanation: Updated Part A and Part B billing instructions.
10/01/2015 R4 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36021 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
11/08/2023 11/16/2023 - N/A Currently in Effect View
12/26/2019 10/24/2019 - 11/15/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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