LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: TP53 Gene Test

A55221

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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.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A55221
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: TP53 Gene Test
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
10/26/2023
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 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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CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

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 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
    • Box 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

Response To Comments

Number Comment Response
1
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Coding Information

Bill Type Codes

Code Description
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Revenue Codes

Code Description
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CPT/HCPCS Codes

Group 1

(2 Codes)
Group 1 Paragraph

NA

Group 1 Codes
Code Description
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)
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CPT/HCPCS Modifiers

Group 1

(2 Codes)
Group 1 Paragraph

N/A

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

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.

Code Description
N/A

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
N/A N/A
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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
10/26/2023 R8

Posted 10/26/2023: Biannual review completed with no change in coverage. No changes were made to the article.

10/28/2021 R7

10/28/2021-Review completed 09/28/2021- updated CMS National Coverage Policy section.

01/01/2021 R6

04/01/2021 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 01/01/2021.

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 01/01/2021.

11/01/2019 R5

Content moved to the new template. Under Article Text removed the last sentence related to reference. Added GX & GY modifiers to the modifier table. Review completed 10/25/2019.

05/30/2019 R4

4/25/19-Removed “the MolDX Team has determined TP53 gene tests are a statutorily excluded service” from the first paragraph.

01/01/2019 R3

01/01/2019-Code update-description change for 81404, 81405. Annual review completed 12/03/2018.

01/01/2018 R2

01/01/2018- Code update-81404 & 81405 description change. Annual review completed 12/07/2017. Removed MolDX will also deny panels of tests that include the TP53 gene. 

03/01/2017 R1 03/01/2017- Annual review 02/01/2017. Added Part A claim submission info and added new trademark for McKesson Z-code ID.
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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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Other URLs
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Public Versions
Updated On Effective Dates Status
10/18/2023 10/26/2023 - N/A Currently in Effect You are here
10/19/2021 10/28/2021 - 10/25/2023 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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