SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: GBA Genetic Testing

A53542

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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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To see the currently-in-effect version of this document, go to the section.

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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A53542
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: GBA Genetic Testing
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
10/24/2019
Revision Ending Date
N/A
Retirement Date
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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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CMS National Coverage Policy

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Article Guidance

Article Text

Effective for dates of service on and after July 30, 2013.

Mutations found in glucosidase, beta, acid (GBA) are associated with Gaucher disease (GD), which encompasses a continuum of clinical findings. Since GBA genetic testing is used to confirm the clinical findings to diagnose GD, the MolDX Team has determined that GBA genetic testing is not a Medicare benefit and is a statutorily excluded service. In addition to single gene testing, MolDX will also deny panels of tests that include the GBA gene as a statutorily excluded service.

To receive a GBA test denial, please submit the following claim information:

  • CPT® code 81251- GBA, common variants
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded services
    • For a voluntary issued ABN, append with GX HCPCS modifier
    • To indicate a statutorily excluded service, append with a GY HCPCS 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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1
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Coding Information

Bill Type Codes

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

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Group 1 Codes
Code Description
81251 GBA (GLUCOSIDASE, BETA, ACID) (EG, GAUCHER DISEASE) GENE ANALYSIS, COMMON VARIANTS (EG, N370S, 84GG, L444P, IVS2+1G>A)
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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

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

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ICD-10-PCS Codes

Group 1

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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

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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
10/24/2019 R7

This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles.

Under Article Title changed the title to “Billing and Coding: MolDX: GBA Genetic Testing”. Under Article Text removed the bullet that reads “Select the appropriate diagnosis for the patient”, and removed the last paragraph. Under CPT/HCPCS Group 1: Codes added CPT® code 81251. Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and GY. CPT® was inserted throughout the article where applicable.

04/12/2018 R6

Completed the annual validation and corrected bullets.

02/26/2018 R5 The Jurisdiction "J" Part A and Part B Contracts for Alabama (10111/10112), Georgia (10211/10212) and Tennessee (10311/10312) are now being serviced by Palmetto GBA. Effective 02/26/18, these 6 contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 6 Part A and B contract numbers) have been completed in this revision.
04/27/2017 R4 Annual review completed. Updated Part-A & Part B billing instructions.
11/19/2015 R3 Removed “MolDX ID (MID) field” and changed back to SV101-7
11/19/2015 R2 Replaced SV101-7 with MID, Removed Palmetto GBA reference and replaced with MolDX.
10/01/2015 R1 Added Annual Review Date.
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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
L35025 - 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
04/19/2024 10/24/2019 - 04/19/2024 Retired View
10/15/2019 10/24/2019 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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