RETIRED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: HBB Gene Tests

A55166

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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
A55166
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: HBB Gene Tests
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
12/28/2023
Revision Ending Date
05/30/2024
Retirement Date
05/30/2024

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CMS National Coverage Policy

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Article Guidance

Article Text

Effective for dates of service on and after 05/03/2013.

HBB gene testing may be performed during the diagnosis of Sickle cell disease (SCD). Since clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit, the MolDX Team has determined HBB gene testing is a statutorily excluded service. MolDX will also deny panels of tests that include the HBB gene.

To receive a HBB gene sequencing service denial, please submit the following claim information:

  • Select the appropriate CPT code based on gene test:
    • 81361- HBB, common variants
    • 81362 -HBB, known familial variants
    • 81363 - HBB, duplication/deletion
    • 81364 - HBB, full gene sequence
    • 81443-Genetic testing for severe inherited conditions.
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
    • For a voluntary issued ABN, append with GX modifier
    • To indicate a statutorily excluded service, append with a GY modifier
  • 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

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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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

Group 1 Paragraph

NA

Group 1 Codes

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

Group 1

Group 1 Paragraph

NA

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.

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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
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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
05/30/2024 R9

Posted 05/30/2024: This article is being retired because it is not supported by a Local Coverage Determination (LCD) and does not comply with current 21st Century Cures requirements.

12/28/2023 R8

Posted 12/28/2023: Biannual review completed with no change in coverage. No changes were made to the article.

12/30/2021 R7

12/30/2021-Review completed 11/08/2021, no changes.

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. Moved CPT code 81443 from CPT/HCPCS Code Group 1 to CPT/HCPCS code Group 2 and added “CPT codes that are also referenced in other articles.” Review completed 11/20/2019.

01/01/2019 R5

02/01/2019-Code update: added 81443.

06/01/2018 R4

06/01/2018- Annual review completed 05/02/2018.

01/01/2018 R3

01/01/2017-2018 Code update-added 81361-81364 & removed 81401, 81403 and 81404. Typo corrected.

07/01/2017 R2

07/01/2017- Annual review completed 06/08/2017; Updated billing instructions, added 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 and updated Part B instructions.

02/16/2017 R1 01/01/2017- Code update-81401 & 81403 description change.
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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
L36807 - 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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Public Versions
Updated On Effective Dates Status
05/30/2024 12/28/2023 - 05/30/2024 Retired You are here
12/20/2023 12/28/2023 - N/A Superseded View
12/20/2021 12/30/2021 - 12/27/2023 Superseded View
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