Local Coverage Article:
Billing and Coding: MolDX: MammaPrint (A53104)
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General Information
General Article Information Table
Article ID
A53104
Article Title
Billing and Coding: MolDX: MammaPrint
Article Type
Billing and Coding
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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Original Effective Date
10/01/2015
Revision Effective Date
10/24/2019
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CMS National Coverage Policy
Article Guidance
Article Text:
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
| CODE | DESCRIPTION |
|
81521
| 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.
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.
Group 1 Paragraph: N/A
Group 1 Codes: N/A
Related Local Coverage Document(s)
Related National Coverage Document(s)
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Statutory Requirements URL(s)
N/A
Rules and Regulations URL(s)
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CMS Manual Explanations URL(s)
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Public Version(s)
Updated on 10/16/2019 with effective dates 10/24/2019 - N/A
Some older versions have been archived. Please visit the to retrieve them.
