Retired Local Coverage Article Billing and Coding

Billing and Coding: MolDX: BRCA1 and BRCA2 Genetic Testing

A57355

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Article Information

General Information

Article ID
A57355
Article Title
Billing and Coding: MolDX: BRCA1 and BRCA2 Genetic Testing
Article Type
Billing and Coding
Original Effective Date
11/01/2019
Revision Effective Date
01/06/2022
Revision Ending Date
08/20/2022
Retirement Date
08/20/2022
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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.

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 16, §50.5 Jurisdiction of Laboratory Claims, §60.1.2 Independent Laboratory Specimen Drawing, §60.2 Travel Allowance

CMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 23, §10 Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The following coding and billing guidance is to be used with its associated Local coverage determination.

To report a BRCA1/BRCA2 Genetic Testing service, please submit the following claim information:

  • Select appropriate CPT® code
  • Enter 1 unit of service (UOS)
  • 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 code



Coding Information

CPT/HCPCS Codes

Group 1

(16 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
81162 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS AND FULL DUPLICATION/DELETION ANALYSIS (IE, DETECTION OF LARGE GENE REARRANGEMENTS)
81163 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS
81164 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL DUPLICATION/DELETION ANALYSIS (IE, DETECTION OF LARGE GENE REARRANGEMENTS)
81165 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS
81166 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL DUPLICATION/DELETION ANALYSIS (IE, DETECTION OF LARGE GENE REARRANGEMENTS)
81167 BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL DUPLICATION/DELETION ANALYSIS (IE, DETECTION OF LARGE GENE REARRANGEMENTS)
81212 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; 185DELAG, 5385INSC, 6174DELT VARIANTS
81215 BRCA1 (BRCA1, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; KNOWN FAMILIAL VARIANT
81216 BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; FULL SEQUENCE ANALYSIS
81217 BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) GENE ANALYSIS; KNOWN FAMILIAL VARIANT
81432 HEREDITARY BREAST CANCER-RELATED DISORDERS (EG, HEREDITARY BREAST CANCER, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER); GENOMIC SEQUENCE ANALYSIS PANEL, MUST INCLUDE SEQUENCING OF AT LEAST 10 GENES, ALWAYS INCLUDING BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, AND TP53
81433 HEREDITARY BREAST CANCER-RELATED DISORDERS (EG, HEREDITARY BREAST CANCER, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER); DUPLICATION/DELETION ANALYSIS PANEL, MUST INCLUDE ANALYSES FOR BRCA1, BRCA2, MLH1, MSH2, AND STK11
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE
0102U HEREDITARY BREAST CANCER-RELATED DISORDERS (EG, HEREDITARY BREAST CANCER, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER), GENOMIC SEQUENCE ANALYSIS PANEL UTILIZING A COMBINATION OF NGS, SANGER, MLPA, AND ARRAY CGH, WITH MMRNA ANALYTICS TO RESOLVE VARIANTS OF UNKNOWN SIGNIFICANCE WHEN INDICATED (17 GENES [SEQUENCING AND DELETION/DUPLICATION])
0103U HEREDITARY OVARIAN CANCER (EG, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER), GENOMIC SEQUENCE ANALYSIS PANEL UTILIZING A COMBINATION OF NGS, SANGER, MLPA, AND ARRAY CGH, WITH MMRNA ANALYTICS TO RESOLVE VARIANTS OF UNKNOWN SIGNIFICANCE WHEN INDICATED (24 GENES [SEQUENCING AND DELETION/DUPLICATION], EPCAM [DELETION/DUPLICATION ONLY])
0129U HEREDITARY BREAST CANCER-RELATED DISORDERS (EG, HEREDITARY BREAST CANCER, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER), GENOMIC SEQUENCE ANALYSIS AND DELETION/DUPLICATION ANALYSIS PANEL (ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, PTEN, AND TP53)

Group 2

(14 Codes)
Group 2 Paragraph

These services are not separately billable from the code to which they must be added on. Claims with these codes will be rejected.

Group 2 Codes
CodeDescription
0131U HEREDITARY BREAST CANCER-RELATED DISORDERS (EG, HEREDITARY BREAST CANCER, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (13 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0132U HEREDITARY OVARIAN CANCER-RELATED DISORDERS (EG, HEREDITARY BREAST CANCER, HEREDITARY OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (17 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0133U HEREDITARY PROSTATE CANCER-RELATED DISORDERS, TARGETED MRNA SEQUENCE ANALYSIS PANEL (11 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0134U HEREDITARY PAN CANCER (EG, HEREDITARY BREAST AND OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER, HEREDITARY COLORECTAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (18 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0135U HEREDITARY GYNECOLOGICAL CANCER (EG, HEREDITARY BREAST AND OVARIAN CANCER, HEREDITARY ENDOMETRIAL CANCER, HEREDITARY COLORECTAL CANCER), TARGETED MRNA SEQUENCE ANALYSIS PANEL (12 GENES) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0136U ATM (ATAXIA TELANGIECTASIA MUTATED) (EG, ATAXIA TELANGIECTASIA) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0137U PALB2 (PARTNER AND LOCALIZER OF BRCA2) (EG, BREAST AND PANCREATIC CANCER) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0138U BRCA1 (BRCA1, DNA REPAIR ASSOCIATED), BRCA2 (BRCA2, DNA REPAIR ASSOCIATED) (EG, HEREDITARY BREAST AND OVARIAN CANCER) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0157U APC (APC REGULATOR OF WNT SIGNALING PATHWAY) (EG, FAMILIAL ADENOMATOSIS POLYPOSIS [FAP]) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0158U MLH1 (MUTL HOMOLOG 1) (EG, HEREDITARY NON-POLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0159U MSH2 (MUTS HOMOLOG 2) (EG, HEREDITARY COLON CANCER, LYNCH SYNDROME) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0160U MSH6 (MUTS HOMOLOG 6) (EG, HEREDITARY COLON CANCER, LYNCH SYNDROME) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0161U PMS2 (PMS1 HOMOLOG 2, MISMATCH REPAIR SYSTEM COMPONENT) (EG, HEREDITARY NONPOLYPOSIS COLORECTAL CANCER, LYNCH SYNDROME) MRNA SEQUENCE ANALYSIS (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
0162U HEREDITARY COLON CANCER (LYNCH SYNDROME), TARGETED MRNA SEQUENCE ANALYSIS PANEL (MLH1, MSH2, MSH6, PMS2) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(82 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
C25.0 Malignant neoplasm of head of pancreas
C25.1 Malignant neoplasm of body of pancreas
C25.2 Malignant neoplasm of tail of pancreas
C25.3 Malignant neoplasm of pancreatic duct
C25.4 Malignant neoplasm of endocrine pancreas
C25.7 Malignant neoplasm of other parts of pancreas
C25.8 Malignant neoplasm of overlapping sites of pancreas
C25.9 Malignant neoplasm of pancreas, unspecified
C48.1 Malignant neoplasm of specified parts of peritoneum
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.019 Malignant neoplasm of nipple and areola, unspecified female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.029 Malignant neoplasm of nipple and areola, unspecified male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.119 Malignant neoplasm of central portion of unspecified female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.129 Malignant neoplasm of central portion of unspecified male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left female breast
C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast
C50.221 Malignant neoplasm of upper-inner quadrant of right male breast
C50.222 Malignant neoplasm of upper-inner quadrant of left male breast
C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female breast
C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast
C50.321 Malignant neoplasm of lower-inner quadrant of right male breast
C50.322 Malignant neoplasm of lower-inner quadrant of left male breast
C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left female breast
C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast
C50.421 Malignant neoplasm of upper-outer quadrant of right male breast
C50.422 Malignant neoplasm of upper-outer quadrant of left male breast
C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.521 Malignant neoplasm of lower-outer quadrant of right male breast
C50.522 Malignant neoplasm of lower-outer quadrant of left male breast
C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.619 Malignant neoplasm of axillary tail of unspecified female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.629 Malignant neoplasm of axillary tail of unspecified male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.819 Malignant neoplasm of overlapping sites of unspecified female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.829 Malignant neoplasm of overlapping sites of unspecified male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
C50.919 Malignant neoplasm of unspecified site of unspecified female breast
C50.921 Malignant neoplasm of unspecified site of right male breast
C50.922 Malignant neoplasm of unspecified site of left male breast
C50.929 Malignant neoplasm of unspecified site of unspecified male breast
C54.1 Malignant neoplasm of endometrium
C56.1 Malignant neoplasm of right ovary
C56.2 Malignant neoplasm of left ovary
C56.3 Malignant neoplasm of bilateral ovaries
C56.9 Malignant neoplasm of unspecified ovary
C57.00 Malignant neoplasm of unspecified fallopian tube
C57.01 Malignant neoplasm of right fallopian tube
C57.02 Malignant neoplasm of left fallopian tube
C61 Malignant neoplasm of prostate
D05.11 Intraductal carcinoma in situ of right breast
D05.12 Intraductal carcinoma in situ of left breast
Z15.04 Genetic susceptibility to malignant neoplasm of endometrium
Z85.07 Personal history of malignant neoplasm of pancreas
Z85.3 Personal history of malignant neoplasm of breast
Z85.43 Personal history of malignant neoplasm of ovary
Z85.44 Personal history of malignant neoplasm of other female genital organs
Z85.46 Personal history of malignant neoplasm of prostate
Z85.89 Personal history of malignant neoplasm of other organs and systems
Z86.000 Personal history of in-situ neoplasm of breast

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 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.

CodeDescription
999x Not Applicable

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


N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
08/20/2022 R6

MolDX: BRCA1 and BRCA2 Genetic Testing LCD L36163 has been incorporated into MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer L38974 LCD. 

01/06/2022 R5

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C25.9, C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C56.9, and C57.00. The deletion of these codes with Revision 7 was done in error and is retroactive effective for dates of service on or after 4/29/2021.

10/01/2021 R4

Effective 10.01.2021: Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C56.3. This revision is due to the Annual ICD-10 Update and will become effective on 10/1/2021.

Effective 04.29.2021: Under CMS National Coverage Policy moved regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 to the related LCD.

Under CPT/HCPCS Codes Group 3: Codes deleted 81445 and 81455. CPT® code 81162 was moved from CPT/HCPCS Codes Group 3: Codes to CPT/HCPCS Codes Group 1: Codes.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted C25.9, C50.019, C50.029, C50.119, C50.129, C50.219, C50.229, C50.319, C50.329, C50.419, C50.429, C50.519, C50.529, C50.619, C50.629, C50.819, C50.829, C50.911, C50.912, C50.919, C50.921, C50.922, C50.929, C56.9, and C57.00. Typographical errors were corrected throughout the article.

07/31/2020 R3

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C54.1 and Z15.04.

01/01/2020 R2

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added Z86.000, Z85.44, and Z85.89. This revision is retroactive effective for dates of service on or after 4/2/19.

Under CPT/HCPCS Codes Group 1: Codes the description changed for 0102U and 0103U. Under CPT/HCPCS Codes Group 2: Codes added 0157U, 0158U, 0159U, 0160U, 0161U and 0162U. This revision is due to the 2020 Annual CPT/HCPCS Code Update and is effective on January 1, 2020.

12/04/2019 R1

12/04/2019: This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual.

Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of the related MolDX: BRCA1 and BRCA2 Genetic Testing L36082 LCD and placed in this article.

Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81433 and removed codes 81162, 81445 and 81455 and placed them under CPT/HCPCS Codes Group 3: Codes.

Under CPT/HCPCS Codes Group 3: Paragraph added verbiage “CPT® codes that are also referenced in other articles”. The above revisions will become effective on 12/4/19.

Under CPT/HCPCS Codes Group 1: Codes code 0104U was deleted and 0129U was added.

Under CPT/HCPCS Codes Group 2: Paragraph added the verbiage “These services are not separately billable from the code to which they must be added on. Claims with these codes will be rejected”.

Under CPT/HCPCS Codes Group 2: Codes added 0131U, 0132U, 0133U, 0134U, 0135U, 0136U, 0137U and 0138U. These revisions are due to the Q4 CPT/HCPCS Code Updates and are retroactive effective for dates of service on or after 10/1/19.

Associated Documents

Related National Coverage Documents
NCDs
90.2 - Next Generation Sequencing (NGS)
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