LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: FDA-Approved BRAF Tests

A54191

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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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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54191
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
11/16/2023
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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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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Revenue Codes

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CPT/HCPCS Codes

Group 1

(1 Code)
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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

Group 1

(56 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
C91.40 Hairy cell leukemia not having achieved remission
C91.42 Hairy cell leukemia, in relapse
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
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

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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
11/16/2023 R18

Revision Effective: 11/16/2023

Revision Explanation: Updated LCD Reference Article section.

07/27/2023 R17

Revision Effective date: 07/27/2023
Revision Explanation: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C91.40 and C91.42.

10/13/2022 R16

Revision Effective date: 10/13/2022
Revision Explanation: 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 R15

Revision Effective date: 03/03/2022
Revision Explanation: 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 R14

Revision Effective date: 10/07/2021
Revision Explanation: Under Article Text revised the sentence, “Tests may be registered on the McKesson Diagnostics Exchange™: https://app.mckessondex.com/#/login” to “Tests may be registered on the DEX™ Diagnostics Exchange https://app.dexzcodes.com/login”.

10/31/2019 R13

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/31/2019 R12

Revision Effective date: 10/31/2019
Revision Explanation: CPT® was inserted throughout the article where applicable. 

10/03/2019 R11

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

10/01/2018 R10

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/01/2018 R9

Revision Effective date: 10/01/2018
Revision Explanation: During annual ICD-10 update C43.11, C43.12, D03.11 and D03.12 were deleted and replaced with the following codes: C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, and D03.122.

12/22/2017 R8

Revision Effective date: 12/22/2017
Revision Explanation: Removed 22 modifier from text as this is no longer valid. Also removed ICd-10 codes from text as listed in the ICD-10 section of the policy.

10/01/2015 R7

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

10/01/2015 R6 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R5 R3
Revision Effective:10/01/2015
Revision Explanation: Added information that this is FDA indications .
10/01/2015 R4 Revision Effective: 10/01/2015
Revision explanation: Changed MolDX ID field to SV101-7 and Z-code to ZCode™ Identifier.
10/01/2015 R3 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R2 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
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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
L36021 - 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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Updated On Effective Dates Status
11/08/2023 11/16/2023 - N/A Currently in Effect You are here
07/25/2023 07/27/2023 - 11/15/2023 Superseded View
10/04/2022 10/13/2022 - 07/26/2023 Superseded View
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