SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: TP53 Gene Test

A53591

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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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General Information

Source Article ID
N/A
Article ID
A53591
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: TP53 Gene Test
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2021
Revision Ending Date
N/A
Retirement Date
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Article Text

Effective for dates of service on and after June 24, 2013

TP53 gene testing may be performed during the diagnosis of Li-Fraumeni syndrome (LFS), a cancer predisposition syndrome associated with the development of specific tumors. Clinical symptoms and diagnosis usually occur prior to Medicare eligibility and carrier testing is not a covered benefit.

To receive a TP53 gene sequencing service denial, please submit the following claim information:

  • Select the appropriate CPT® code
  • An Advance Beneficiary Notice (ABN) is not required for statutorily excluded
    • 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 services.
  • Select the appropriate diagnosis for the patient
  • 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 clai
  • 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

 

Response To Comments

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Coding Information

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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.

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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
01/01/2021 R8

Under Article Text revised the verbiage under the first bullet to read, “Select the appropriate CPT® code”. Under CPT/HCPCS Codes Group 1: Codes deleted 81404 and 81405. The revision is retroactive effective for dates of services on or after 1/1/2021.

Under CPT/HCPCS Codes Group 1: Codes added 81351 and 81352. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021.

10/31/2019 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. Under Article Title changed the title from “MolDX: TP53 Gene Test Coding and Billing Guidelines” to “the Billing and Coding: MolDX: TP53 Gene Test”. Under Article Text removed the last paragraph. Under CPT/HCPCS Codes Group 1: Codes added 81404 and 81505. Under CPT/HCPCS Modifiers Group 1: Codes added modifiers GX and GY.

05/02/2019 R6

Made revisions to the first paragraph to remove the statutorily excluded service.

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.
11/23/2017 R4

Corrected bulleting issues. Removed "MolDX will also deny panels of tests that include the TP53 gene." from the article.

12/24/2015 R3 Annual review. updated with part a clm submission info and new trademark for McKesson z-code ID.
12/31/2015 R2 Completed annual review, reverted back to SV101-7 and removed MolDX ID (MID) field
11/19/2015 R1 Replace Palmetto reference with MolDX and replaced SV101-7 with MolDX ID (MID) field
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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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Public Versions
Updated On Effective Dates Status
05/01/2024 01/01/2021 - 05/01/2024 Retired View
03/08/2021 01/01/2021 - 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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