Billing and Coding: MolDX: FDA-Approved BRAF Tests (A54418)


Related Local Coverage Determination (LCD)
L35160-MolDX: Molecular Diagnostic Tests (MDT)


Contractor NameContract NumberStates
Noridian Healthcare Solutions, LLC 01111 - A and B MAC California - Entire State
01112 - A and B MAC California - Northern
01182 - A and B MAC California - Southern
01211 - A and B MAC American Samoa
Guam
Hawaii
Northern Mariana Islands
01212 - A and B MAC American Samoa
Guam
Hawaii
Northern Mariana Islands
01311 - A and B MAC Nevada
01312 - A and B MAC Nevada
01911 - A and B MAC American Samoa
California - Entire State
Guam
Hawaii
Nevada
Northern Mariana Islands

Article Information

Article ID Number: A54418 Status: A-Approved

Article Title: Billing and Coding: MolDX: FDA-Approved BRAF Tests

Original Article Effective Date: 10/01/2015

Revision Effective Date: 07/27/2023

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, 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
    • Item 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.

 

Coding Information
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 policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.


CPT/HCPCS Codes:

Group 1 Paragraph:

N/A



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


ICD-10 Codes That Are Covered

N/A

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
ICD-10 Codes That Are Not Covered

N/A


Revision History Information
Revision History DateRevision History NumberRevision History Explanation
07/27/2023
R8

Updated to indicate this article is an LCD Reference Article.

07/27/2023
R7

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C91.40 and C91.42. 

Under CMS National Coverage Policy re-added Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim effective on 03/03/2022

 

10/13/2022
R6

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
R5

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. 

11/01/2019
R4

11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, 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

11/01/2019
R3

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

10/01/2018
R2

Article is revised to add the following ICD-10 codes per the 2019 Annual Update: C43.111, C43.112, C43.121, C43.122, D03.111, D03.112, D03.121, D03.122. 

The following codes are deleted:C43.11, C43.12, D03.11, D03.12.

12/14/2017
R1

Article is updated for consistency with the MolDX Contractor: to remove modifier 22 instructions; added Part A claim filing instructions and correct reference to and website address for DEX™ Diagnostics Exchange.

Article number A54417 for Jurisdiction E Part A (JEA) was retired on January 29, 2018, and combined into Jurisdiction E Part B (JEB) article number A54418.  JEA and JEB contract numbers will have the same final MCD article number.