Superseded Local Coverage Article Billing and Coding

Billing and Coding: MolDX: MAMMAPRINT

A54445

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Superseded

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Contractor Information

Article Information

General Information

Article ID
A54445
Article Title
Billing and Coding: MolDX: MAMMAPRINT
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/01/2019
Revision Ending Date
10/07/2021
Retirement Date
N/A
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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

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Article Guidance

Article Text

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

MAMMAPRINT™, an FDA cleared in vitro microarray diagnostic test that uses gene expression profiling to analyze the gene activity of the identified tumor, has been assigned a unique identifier.

MAMMAPRINTTM is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.

MAMMAPRINT was prospectively validated in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status.

To bill for MAMMAPRINT™ services, submit the following claim information:

  • Enter “1” in the Days/Unit field
  • For CPT non-NOC codes, Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
  • 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


 Note: Noridian expects this test may be performed upon occasion twice per patient lifetime for bilateral disease. Should a patient experience an additional occurrence, coverage may be considered with supporting documentation through the appeal process.

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
81521 ONCOLOGY (BREAST), MRNA, MICROARRAY GENE EXPRESSION PROFILING OF 70 CONTENT GENES AND 465 HOUSEKEEPING GENES, UTILIZING FRESH FROZEN OR FORMALIN-FIXED PARAFFIN-EMBEDDED TISSUE, ALGORITHM REPORTED AS INDEX RELATED TO RISK OF DISTANT METASTASIS

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(36 Codes)
Group 1 Paragraph

Select the appropriate ICD-10-CM code from the following:

Group 1 Codes
CodeDescription
C50.011 Malignant neoplasm of nipple and areola, right female breast
C50.012 Malignant neoplasm of nipple and areola, left female breast
C50.021 Malignant neoplasm of nipple and areola, right male breast
C50.022 Malignant neoplasm of nipple and areola, left male breast
C50.111 Malignant neoplasm of central portion of right female breast
C50.112 Malignant neoplasm of central portion of left female breast
C50.121 Malignant neoplasm of central portion of right male breast
C50.122 Malignant neoplasm of central portion of left male breast
C50.211 Malignant neoplasm of upper-inner quadrant of right female breast
C50.212 Malignant neoplasm of upper-inner quadrant of left 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
C50.311 Malignant neoplasm of lower-inner quadrant of right female breast
C50.312 Malignant neoplasm of lower-inner quadrant of left 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
C50.411 Malignant neoplasm of upper-outer quadrant of right female breast
C50.412 Malignant neoplasm of upper-outer quadrant of left 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
C50.511 Malignant neoplasm of lower-outer quadrant of right female breast
C50.512 Malignant neoplasm of lower-outer quadrant of left 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
C50.611 Malignant neoplasm of axillary tail of right female breast
C50.612 Malignant neoplasm of axillary tail of left female breast
C50.621 Malignant neoplasm of axillary tail of right male breast
C50.622 Malignant neoplasm of axillary tail of left male breast
C50.811 Malignant neoplasm of overlapping sites of right female breast
C50.812 Malignant neoplasm of overlapping sites of left female breast
C50.821 Malignant neoplasm of overlapping sites of right male breast
C50.822 Malignant neoplasm of overlapping sites of left male breast
C50.911 Malignant neoplasm of unspecified site of right female breast
C50.912 Malignant neoplasm of unspecified site of left female breast
Z17.0 Estrogen receptor positive status [ER+]
Z17.1 Estrogen receptor negative status [ER-]

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

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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.

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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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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
11/01/2019 R5

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

01/01/2018 R4

Added the following: "MAMMAPRINT™ is a qualitative in vitro diagnostic test service, performed in a single laboratory, using the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.

MAMMAPRINT was prospectively validated in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status."

01/01/2018 R3

Removed the FDA decision summary.

01/01/2018 R2

Added the FDA decision summary providing the intended use information.

01/01/2018 R1

The following updates were made per the 2018 annual HCPCS update: 

Added: 81521 

Deleted: 81479, 84999 

Added Part A billing instructions. 

Article number A54444 for Jurisdiction E Part A (JEA) was retired on 01/01/2018 and combined into Jurisdiction E Part B (JEB) article number A54445.  JEA and JEB contract numbers will have the same final MCD article number. Coverage remains the same.

 

 

Associated Documents

Related Local Coverage Documents
LCDs
L35160 - 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
01/25/2022 01/01/2022 - N/A Currently in Effect View
12/17/2021 10/08/2021 - 12/31/2021 Superseded View
10/16/2019 11/01/2019 - 10/07/2021 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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