Local Coverage Article Billing and Coding

Billing and Coding: MolDX: FDA-Approved BRAF Tests

A55161

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Contractor Information

Article Information

General Information

Article ID
A55161
Article Title
Billing and Coding: MolDX: FDA-Approved BRAF Tests
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
03/31/2022
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 2021 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

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 5/29/2013.
    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
  • Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
  • Enter the assigned DEX Z-Code™ Identifier in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Submit the assigned DEX Z-Code™ Identifier on an attachment to the claim form 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:  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.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code) >> Includes 81210
Group 1 Paragraph

N/A

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

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(38 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
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

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

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

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.

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.

N/A

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
03/31/2022 R9

Posted 03/31/2022-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. Review completed 02/17/2022.

10/28/2021 R8

10/28/2021- Review completed 09/17/2021-corrected the trademark to DEX™ Diagnostics Exchange.

11/01/2019 R7

Content moved to the new template. Review completed 11/18/2019.

10/01/2018 R6

10/01/2018 – ICD-010 code update removed deleted codes C43.11, C43.12, D03.11 & D03.12. Added C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122.

07/01/2018 R5

07/01/2018-Annual review completed 06/07/2018. Removed reference to NPI editing.

02/01/2018 R4

02/01/2018 - Corrected typographical error in URL for link to https://app.dexzcodes.com/login. No other changes to coverage or article.

02/01/2018 R3

02/01/2018- Removed modifier 22 BRAF, V600E and “For lab developed tests (LDT) or tests that modify a BRAF V600 test, CPT code 81210 and NO modifier should be reported and submitted with the assigned LDT test ID”. Replaced McKesson Diagnostics ExchangeTM: with DEX Diagnostics Exchange TM.

08/01/2017 R2

07/28/2017 - Corrected typo, removed extra "Z-" under second sub-bullet of third bullet point in Article Text section.

08/01/2017 R1

08/01/2017- Annual review completed 07/06/2017; Updated billing instructions, added Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information & added Part A billing instructions and updated Part B instructions.

 

Associated Documents

Related Local Coverage Documents
LCDs
L36807 - 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
03/22/2022 03/31/2022 - N/A Currently in Effect You are here
10/19/2021 10/28/2021 - 03/30/2022 Superseded View
11/22/2019 11/01/2019 - 10/27/2021 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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