RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests

A54262

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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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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
11/16/2023
Revision Ending Date
04/18/2024
Retirement Date
04/18/2024

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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








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Coding Information

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CPT/HCPCS Modifiers

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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

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

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ICD-10-PCS Codes

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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.

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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.

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Other Coding Information

Group 1

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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
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
04/18/2024 R14

This article is being retired as it is not supported by a Local Coverage Determination (LCD) and does not comply with current 21st Century Cures requirements. 

11/16/2023 R13

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

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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Public Versions
Updated On Effective Dates Status
04/18/2024 11/16/2023 - 04/18/2024 Retired You are here
11/08/2023 11/16/2023 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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