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.