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Article Title
Billing and Coding: MolDX: ATP7B Gene Tests
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Article Text
ATP7B gene mutations have been primarily associated with Wilson Disease, a disorder of copper metabolism.
However, serology remains the gold standard for testing and treating the signs and symptoms of this
condition. At present the literature does not support that ATP7B gene testing changes physician treatment or
improves patient outcomes. Therefore, the MolDX Team has determined ATP7B gene testing is a statutorily
excluded service. MolDX will also deny panels of tests that include the ATP7B gene.
To receive an ATP7B gene test denial, please submit the following claim information:
CMS National Coverage Policyo:p 1
• Select the appropriate CPT® code for the performed service:
♦ 81406 - ATP7B, fgs
♦ 81443 - Genetic Testing for severe genetic conditions
♦ 81479 - Unlisted molecular pathology procedure
• 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
• Enter 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
♦ Item 19 for paper claim
• Enter 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
(1 Code)
Group 1 Paragraph
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Group 1 Codes
Code Description
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
(2 Codes)
Group 2 Paragraph
CPT® codes that are also referenced in other articles.
Group 2 Codes
Code Description
81406MOLECULAR 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)
81443GENETIC TESTING FOR SEVERE INHERITED CONDITIONS (EG, CYSTIC FIBROSIS,
ASHKENAZI JEWISH-ASSOCIATED DISORDERS [EG, BLOOM SYNDROME, CANAVAN
Article Guidanceo:p 2
DISEASE, FANCONI ANEMIA TYPE C, MUCOLIPIDOSIS TYPE VI, GAUCHER DISEASE,
TAY-SACHS DISEASE], BETA HEMOGLOBINOPATHIES, PHENYLKETONURIA,
GALACTOSEMIA), GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE
SEQUENCING OF AT LEAST 15 GENES (EG, ACADM, ARSA, ASPA, ATP7B, BCKDHA,
BCKDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GBA, GBE1, HBB, HEXA,
IKBKAP, MCOLN1, PAH)
(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
Group 1 Paragraph
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Group 1 Codes
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Group 1 Paragraph
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Group 1 Codes
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Group 1 Paragraph
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Group 1 Codes
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Group 2o:p 3
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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
0x TBD
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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Group 1 Paragraph
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Group 1 Codes
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Revision Revision
History History
Date Number Revision History Explanation
12/17/2021R3 Noridian has modified certain language in this article to mirror the language used
presently by the MolDX team at Palmetto GBA as part of an annual review. Revision
history dates and language may not exactly match the MolDX PGBA revision history
but is updated with the revisions made in an accurate timeline. However, these revisions
do not change coverage or guidance.
12/01/2019R2 As required by CR 10901, article is converted to a formal billing and coding type article.
There is no change in coverage.
References were added to the CMS National Coverage Policy Section.
Under Article Title changed the title to Billing and Coding: MolDX: ATP7B Gene
Testing . Under Article Text removed the bullet that reads Select the appropriate
diagnosis for the patient , and removed the last paragraph. Under CPT/HCPCS
Codes moved CPT® codes 81406 and 81443 from Group 1: Codes to Group 2: Codes.
Under Group 2: Paragraph added the verbiage "CPT® codes that are also referenced in
Additional ICD-10 Informationo:p 4
other articles." Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and
GY. CPT® was inserted throughout the article where applicable.
10/17/2016R1 Article is revised to update "the assigned identifier" to "DEX Z-Code identifier" and
add Part A claim filing information.
Related Local Coverage Documents
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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
02/25/2022 12/17/2021 - N/A Currently in Effect You are here
Revision History Informationo:p 5
