Local Coverage Article Billing and Coding

Billing and Coding: MolDX: Breast Cancer Index® (BCI) Gene Expression Test

A57773

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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
A57773
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Breast Cancer Index® (BCI) Gene Expression Test
Article Type
Billing and Coding
Original Effective Date
01/01/2020
Revision Effective Date
10/09/2021
Revision Ending Date
N/A
Retirement Date
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AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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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 lacking the necessary documentation to process the claim.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80.0 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes

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 information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Breast Cancer Index® (BCI) Gene Expression Test.

Effective 1/01/2019, MolDX will provide limited coverage for the BCI gene expression test.

The BCI test is covered for postmenopausal women with invasive breast cancer when the following criteria are met:

  • Pathology reveals invasive carcinoma of the breast that is ER+ and/or PR+ and HER2 -; and
  • Patient has early-stage disease (T1-3, pN0-N1, M0); and
  • Patient has no evidence of distant breast cancer metastasis (i.e., non-relapsed); and
  • Test results will be used in determining treatment management of the patient for chemotherapy and/or endocrine therapy.

MolDX expects this test will be performed once per patient lifetime on formalin-fixed, paraffin-embedded (FFPE) tissue from the primary tumor specimen obtained prior to adjuvant treatment.

To report a BCI service, please submit the following claim information:

  • Select CPT® code 81518
  • Enter 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
    • 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 code

 

Response To Comments

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Coding Information

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Revenue Codes

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CPT/HCPCS Codes

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(1 Code)
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Group 1 Codes
Code Description
81518 ONCOLOGY (BREAST), MRNA, GENE EXPRESSION PROFILING BY REAL-TIME RT-PCR OF 11 GENES (7 CONTENT AND 4 HOUSEKEEPING), UTILIZING FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHMS REPORTED AS PERCENTAGE RISK FOR METASTATIC RECURRENCE AND LIKELIHOOD OF BENEFIT FROM EXTENDED ENDOCRINE THERAPY
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CPT/HCPCS Modifiers

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(17 Codes)
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Group 1 Codes
Code Description
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left female 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left female breast
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
Z17.0 Estrogen receptor positive status [ER+]
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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.

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Other Coding Information

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Group 1 Codes

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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
10/09/2021 R2

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted C50.911 and C50.912. Under article text added: The information in this article contains billing, coding, or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Breast Cancer Index® (BCI) Gene Expression Test.

05/10/2021 R1

Under Article Title and Article Text trademark was changed to registered mark.

Under CMS National Coverage Policy regulation CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes was moved to the related LCD.

Under Article Text removed third bullet and related verbiage and removed verbiage “extension of” from fourth bullet. Revised verbiage under fifth paragraph to read “To report a BCI service, please submit the following claim information, added “Select” to the first bullet, revised verbiage in second bullet to read “Enter 1 unit of service (UOS)”, revised verbiage in the third bullet to read “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”, added verbiage “the appropriate” to the fourth bullet.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes deleted C50.019, C50.119, C50.219, C50.319, C50.419, C50.519, C50.619, C50.819 and C50.919. Formatting, punctuation and typographical errors were corrected throughout the article. Acronyms were defined where appropriate throughout the article.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
11/30/2021 10/09/2021 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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