SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: FDA-Approved BRAF Tests

A54018

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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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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54018
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: FDA-Approved BRAF Tests
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
10/13/2022
Revision Ending Date
07/26/2023
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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, 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.

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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

Two tests have met the FDA criteria for BRAF genetic testing:

    1. Effective 09/07/2012
      cobas® 4800 BRAF V600 to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf ™(vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body.
    2. Effective 5/29/13
      ThxID™ BRAF V600/K to detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].


To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, please submit the following claim information:

  • CPT® code 81210
  • 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
  • Select the appropriate ICD-10-CM diagnosis.


NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kit MUST register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on the DEX™ Diagnostics Exchange https://app.dexzcodes.com/login

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

Response To Comments

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Coding Information

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CPT/HCPCS Codes

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Group 1 Codes
Code Description
81210 BRAF (B-RAF PROTO-ONCOGENE, SERINE/THREONINE KINASE) (EG, COLON CANCER, MELANOMA), GENE ANALYSIS, V600 VARIANT(S)
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CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

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(54 Codes)
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Group 1 Codes
Code Description
C18.0 Malignant neoplasm of cecum
C18.1 Malignant neoplasm of appendix
C18.2 Malignant neoplasm of ascending colon
C18.3 Malignant neoplasm of hepatic flexure
C18.4 Malignant neoplasm of transverse colon
C18.5 Malignant neoplasm of splenic flexure
C18.6 Malignant neoplasm of descending colon
C18.7 Malignant neoplasm of sigmoid colon
C18.8 Malignant neoplasm of overlapping sites of colon
C18.9 Malignant neoplasm of colon, unspecified
C19 Malignant neoplasm of rectosigmoid junction
C20 Malignant neoplasm of rectum
C21.0 Malignant neoplasm of anus, unspecified
C21.1 Malignant neoplasm of anal canal
C21.2 Malignant neoplasm of cloacogenic zone
C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal
C43.0 Malignant melanoma of lip
C43.111 Malignant melanoma of right upper eyelid, including canthus
C43.112 Malignant melanoma of right lower eyelid, including canthus
C43.121 Malignant melanoma of left upper eyelid, including canthus
C43.122 Malignant melanoma of left lower eyelid, including canthus
C43.21 Malignant melanoma of right ear and external auricular canal
C43.22 Malignant melanoma of left ear and external auricular canal
C43.31 Malignant melanoma of nose
C43.39 Malignant melanoma of other parts of face
C43.4 Malignant melanoma of scalp and neck
C43.51 Malignant melanoma of anal skin
C43.52 Malignant melanoma of skin of breast
C43.59 Malignant melanoma of other part of trunk
C43.61 Malignant melanoma of right upper limb, including shoulder
C43.62 Malignant melanoma of left upper limb, including shoulder
C43.71 Malignant melanoma of right lower limb, including hip
C43.72 Malignant melanoma of left lower limb, including hip
C43.8 Malignant melanoma of overlapping sites of skin
C43.9 Malignant melanoma of skin, unspecified
C79.2 Secondary malignant neoplasm of skin
D03.0 Melanoma in situ of lip
D03.111 Melanoma in situ of right upper eyelid, including canthus
D03.112 Melanoma in situ of right lower eyelid, including canthus
D03.121 Melanoma in situ of left upper eyelid, including canthus
D03.122 Melanoma in situ of left lower eyelid, including canthus
D03.21 Melanoma in situ of right ear and external auricular canal
D03.22 Melanoma in situ of left ear and external auricular canal
D03.39 Melanoma in situ of other parts of face
D03.4 Melanoma in situ of scalp and neck
D03.51 Melanoma in situ of anal skin
D03.52 Melanoma in situ of breast (skin) (soft tissue)
D03.59 Melanoma in situ of other part of trunk
D03.61 Melanoma in situ of right upper limb, including shoulder
D03.62 Melanoma in situ of left upper limb, including shoulder
D03.71 Melanoma in situ of right lower limb, including hip
D03.72 Melanoma in situ of left lower limb, including hip
D03.8 Melanoma in situ of other sites
D03.9 Melanoma in situ, unspecified
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS 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

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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
10/13/2022 R14

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C18.0, C18.1,C18.2, C18.3, C18.4, C18.5, C18.6, C18.7, C18.8, C18.9, C19, C20, C21.0, C21.1, C21.2, C21.8

03/03/2022 R13

Under CMS National Coverage Policy added regulation, Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Under Article Text, revised sentence to read, “To report an FDA approved or laboratory developed test (LDT) BRAF V600 test kit service, please submit the following claim information. “ This revision is effective on 03/03/2022. 

10/07/2021 R12

Under Article Text revised the sentence, “Tests may be registered on the McKesson Diagnostics Exchange™:” to “Tests may be registered on the DEX™ Diagnostics Exchange”.

10/24/2019 R11

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 CPT/HCPCS Codes Group 1: Codes added CPT® code 81210. CPT® was inserted throughout the article where applicable.

10/01/2018 R10

Added the following ICD-10 Codes to Covered ICD-10 Codes Group 1: Codes C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122. The following codes were deleted from Covered ICD-10 Codes Group 1: Codes: C43.11, C43.12, D03.11, D03.12. This update is result of the 2018 Annual ICD-10 Updates.

 

 

02/26/2018 R9 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
01/29/2018 R8 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
12/14/2017 R7

Removed modifier 22 references.

01/19/2017 R6 Annual review completed, updated article with part a clm submission info and added new trademark for McKesson Z-code ID.
02/24/2016 R5 Added statement that MolDX will approve all future FDA-approved indications to the end of article.
01/14/2016 R4 Annual review completed, no changes needed.
12/10/2015 R3 Reverted back to SV101-7 and for trade mark purposes, replaced ID/MolDX identifier/Z-Code to read Z-Code™ Identifier
11/19/2015 R2 Replaced SV101-7 with MID, and removed 2014 coding references
10/01/2015 R1 Removed ICD-9 and ICD-10 codes from the article text.
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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
07/21/2023 07/27/2023 - N/A Currently in Effect View
10/04/2022 10/13/2022 - 07/26/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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