Local Coverage Article Billing and Coding

Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests

A55159

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Contractor Information

Article Information

General Information

Article ID
A55159
Article Title
Billing and Coding: MolDX: ENG and ACVRL1 Gene Tests
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
11/25/2021
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2021 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.

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Copyright © 2013 - 2022, the American Hospital Association, Chicago, Illinois. Reproduced by CMS 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. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

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, the MolDX Team 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 DEX Z-Code™ Identifier, 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 

Coding Information

CPT/HCPCS Codes

Group 1

(3 Codes)
Group 1 Paragraph

81479- for ACVRL1 and ACVRL1 and ENG

Group 1 Codes
CodeDescription
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

CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
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

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

NA

Group 1 Codes

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

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.

N/A

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

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
11/25/2021 R7

11/25/2021-Review completed 10/14/2021; no changes made.

11/01/2019 R6

Content moved to the new template. Under Article Text deleted the statement “Select the appropriate diagnosis for the patient” & the last sentence related to a reference. Added GX & GY modifiers to the modifier table. Review completed 11/20/2019

01/01/2019 R5

02/01/2019-removed CPT 81403.

01/01/2019 R4

01/01/2019-Code update: 81403 & 81405 long description changes.

12/01/2018 R3

12/01/2018- Annual review completed 11/07/2018.

01/01/2018 R2

01/01/2018- Code update-81403, 81405, 81406 description change.  Annual review completed 12/07/2017.

06/01/2017 R1 Annual review completed 05/02/2017; Updated billing instructions, added 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 & added Part A billing instructions.

Associated Documents

Related Local Coverage Documents
LCDs
L36807 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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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
11/16/2021 11/25/2021 - N/A Currently in Effect You are here
11/22/2019 11/01/2019 - 11/24/2021 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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