Local Coverage Article:
Billing and Coding: MolDX: MammaPrint (A53104)
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General Article Information Table
Billing and Coding: MolDX: MammaPrint
Billing and Coding
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Original Effective Date
Revision Effective Date
CMS National Coverage Policy
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.
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.
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
- 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
Note: MolDX 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.
Group 1 Paragraph: N/A
Group 1 Codes:
CPT/HCPCS Codes Information Table
||Onc breast mrna 70 genes
Group 1 Paragraph: N/A
Group 1 Codes: N/A
ICD-10 Codes that Support Medical Necessity
ICD-10 Codes that DO NOT Support Medical Necessity
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.
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.
Group 1 Paragraph: N/A
Group 1 Codes: N/A
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 Article Title changed title from “MolDX: MammaPrint Billing and Coding Guidelines Update” to “Billing and Coding: MolDX: MammaPrint”. Under Bill Type Codes deleted code 999x as it is not applicable. CPT® was inserted throughout the article where applicable.
Made revisions to the article to include the following text:
"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."
Removed FDA decision summary.
Added FDA decision summary information to the article.
|02/26/2018||R11||The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
|01/29/2018||R10||The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
|01/01/2018||R9||Changed the CPT code from 81479 to 51521. Corrected bulleting issues.
2018 Annual CPT/HCPCS Updates: Added 81521 CPT/HCPCS Code.
|04/27/2017||R7||Annual review completed. Updated Part-A & Part B billing instructions.
|01/14/2016||R6||Removed I-9 and 2014 coding information.
|10/01/2015||R5||Added the word "assigned" before Z-Code Identifier
|10/01/2015||R4||Removed Z-Code Identifier.
|10/01/2015||R3||Removed ICD-9 and ICD-10 codes from article text.
|04/23/2015||R2||Updated Annual Review Date.
|10/01/2015||R1||Changed the identifier from PB864 to ZB864 and added ICD-10 codes to coding section.
Related Local Coverage Document(s)
Related National Coverage Document(s)
Statutory Requirements URL(s)
Rules and Regulations URL(s)
CMS Manual Explanations URL(s)
Updated on 10/16/2019 with effective dates 10/24/2019 - N/A
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