Local Coverage Article Billing and Coding

Billing and Coding: MolDX: TP53 Gene Tests

A55487

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Contractor Information

Article Information

General Information

Article ID
A55487
Article Title
Billing and Coding: MolDX: TP53 Gene Tests
Article Type
Billing and Coding
Original Effective Date
05/22/2017
Revision Effective Date
12/17/2021
Revision Ending Date
N/A
Retirement Date
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AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 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 © 2022, the American Hospital Association, Chicago, Illinois. Reproduced 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. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Guidance

Article Text

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 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
  • 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
    • 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

 

Coding Information

CPT/HCPCS Codes

Group 1

(2 Codes)
Group 1 Paragraph

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Group 1 Codes
CodeDescription
81351 TP53 (TUMOR PROTEIN 53) (EG, LI-FRAUMENI SYNDROME) GENE ANALYSIS; FULL GENE SEQUENCE
81352 TP53 (TUMOR PROTEIN 53) (EG, LI-FRAUMENI SYNDROME) GENE ANALYSIS; TARGETED SEQUENCE ANALYSIS (EG, 4 ONCOLOGY)

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

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Group 1 Codes

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

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.

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
12/17/2021 R5

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.

12/01/2019: This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual.

01/01/2021 R4

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.

12/01/2019 R3

As required by CR 10901, article is converted to a formal billing and coding type article. There is no change in coverage.

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.  References were added to the CMS National Coverage Policy Section.

11/29/2017 R2

Removed "...the MolDX Team has determined TP53 gene tests are a statutorily excluded service."

11/29/2017 R1

The descriptor for 81405 was changed. Deleted the following text, “MolDX will also deny panels of tests that include the TP53 gene."

Associated Documents

Related Local Coverage Documents
LCDs
L36256 - 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
02/24/2022 12/17/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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