Local Coverage Article Billing and Coding

Billing and Coding: MolDX: MammaPrint

A54447

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Contractor Information

Article Information

General Information

Article ID
A54447
Article Title
Billing and Coding: MolDX: MammaPrint
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
01/01/2022
Revision Ending Date
N/A
Retirement Date
N/A
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

N/A

Article Guidance

Article Text

MammaPrint® is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patients' risk for distant metastasis.

The test can be performed using either a FDA-cleared in vitro microarray assay or a next generation sequencing (NGS)-based assay. Each assay has been assigned a unique Z-code identifier in the DEX Registry.

MammaPrint® was prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The Mammaprint® NGS test has demonstrated technically equivalent performance to the predicate microarray test. 

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. For dates of service on or after 01/01/2022, use CPT® code 81523 for the test if performed by NGS. 
    • Enter the 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  

Only one test- NGS or microarray may be performed on a given date of service for a given patient.

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

(3 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
81479 Unlisted molecular pathology
81521 Onc breast mrna 70 genes
81523 Onc brst mrna 70 cnt 31 gene

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

(36 Codes)
Group 1 Paragraph

N/A

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

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.

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.

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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
01/01/2022 R7

Under Article Text deleted the first paragraph. The second paragraph was revised to read, “MammaPrint® is a diagnostic test that analyzes the gene expression profile of FFPE breast cancer tissue samples to assess a patient’s risk for distant metastasis” and a new third paragraph was added. The second bullet point was revised to add the verbiage, “For dates of service on or after 01/01/2022, use CPT code 81523 for the test if performed by NGS”. A new paragraph was added after verbiage regarding instructions on how to submit claims information. This revision is effective for dates of service on or after 1/1/2022.

Under CPT/HCPCS Codes Group 1: Codes added 81523. This revision is due to the 2022 Annual CPT/HCPCS Code Update and is effective on 1/1/2022.

10/08/2021 R6

10/08/2021: Under Article Text revised the first sentence to read, “MammaPrint®, a next-generation sequencing (NGS)-based diagnostic test that uses gene expression profiling to analyze the gene activity of the identified tumor, has been assigned a unique identifier” and revised the third sentence to read, “MammaPrint® was prospectively validated as a microarray assay in the 6,693 patient MINDACT trial in early stage breast cancer, <5cm up to 3 positive lymph nodes and independent of receptor status. The Mammaprint® NGS test has demonstrated technically equivalent performance to the predicate microarray test”.

Under CPT/HCPCS Codes Group 1: Codes added 81479. Mammaprint® was inserted throughout the article where applicable.

10/01/2015: Under Does the CPT 30% Coding Rule Apply: changed to yes. Retroactive back to the creation of the policy.

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 A54446 for Jurisdiction F Part A (JFA) was retired on 01/01/2018 and combined into Jurisdiction F Part B (JFB) article number A54447.  JFA and JFB contract numbers will have the same final MCD article number. Coverage remains the same.

 

 

 

Associated Documents

Related Local Coverage Documents
LCDs
L36256 - 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 You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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