CPT 81479 Description

Brief description – Noninvasive Prenatal Testing for Fetal Aneuploidies Using Cell-Free Fetal DNA

Information required – • Maternal age 35 years or older at delivery;
• Fetal ultrasonographic findings indicating increased risk of aneuploidy;
• History of previous pregnancy with a trisomy;
• Standard serum screening test positive for aneuploidy; or
• Parental balanced robertsonian translocation with increased risk of fetal trisomy 13 or trisomy 21

Medicare Guidelines

All genomic sequencing procedures and molecular multianalyte assays (e.g., CPT codes 81410-81471), many multianalyte assays with algorithmic analyses (e.g., CPT codes 81490-81599, 0004M-XXXXM), and many Proprietary Laboratory Analyses (PLA) (e.g., CPT codes 0001U-XXXXU) are DNA or RNA analytic methods that simultaneously assay multiple genes or genetic regions. A provider/supplier shall not additionally separately report testing for the same gene or genetic region by a different methodology (e.g., CPT codes 81105-81408, 81479, 88364-88377). CMS payment policy does not allow separate payment for multiple methods to test for the same analyte.

If one laboratory procedure evaluates multiple genes using a next generation sequencing procedure, the laboratory shall report only one unit of service of one genomic sequencing procedure, molecular multianalyte assay, multianalyte assay with algorithmic analysis, or proprietary laboratory analysis CPT code. If no CPT code accurately describes the procedure performed, the laboratory may report CPT code 81479 (Unlisted molecular pathology procedure) with one unit of service or may report multiple individual CPT codes describing the component test results when medically reasonable and necessary. Procedures reported together must be both medically reasonable and necessary (e.g., sequencing of procedures) and ordered by the physician who is treating the beneficiary and using the results in the management of the beneficiary’s specific medical problem.

General billing policy guideliens

This policy describes the information required when claims are submitted for Molecular Pathology services utilizing Tier 1 and Tier 2 Molecular Pathology codes, Genomic Sequencing Procedures (GSP) and other Molecular Multianalyte Assay codes, Proprietary Laboratory Analysis (PLA) codes and unlisted code 81479
All services described in this policy may be subject to additional UnitedHealthcare reimbursement policies including, but not limited to, the Clinical Laboratory Improvement Amendments (CLIA) ID Requirement Policy, the Laboratory Services Policy, the Add-On Policy, and the CCI Editing Policy.

Tier 1 molecular pathology codes represent gene-specific and genomic procedures. Molecular pathology procedures that are not specified in a Tier 1 code should be reported using either the appropriate Tier 2 code or the unlisted molecular pathology procedure code, 81479

Individual Tier 1 or Tier 2 codes are considered components to GSP, PLA, or unlisted codes reported for Multianalyte testing on the same specimen. Individual Tier 1 or Tier 2 codes submitted in addition to a GSP, PLA or unlisted code 81479 will be denied.

According to the AMA, code 81479, unlisted molecular pathology procedure, should only be used for a unique procedure that is not adequately addressed by any other CPT code. It should be reported only once per patient, per specimen and date of service to identify the services provided

In order to identify the molecular pathology procedure performed the provider must submit the unique test ID provided through the National Institutes of Health (NIH) Genetic Testing Registry (GTR). The GTR unique test ID proceeding the decimal should be submitted in field 2400 SV101-7 on the electronic claim form or in the shaded of the service line in section 24 on a paper claim form (example: GTR123456789). The units for CPT code 81479 will be limited by the number of separate specimen types processed on a single patient and each unit of 81479 should be reported on a separate line with a unique GTR test ID for each unit reported (example: testing performed on bone marrow and a blood specimen for different genetic scenarios would be reported on separate lines with the specific GTR test ID listed on each line). Additional information regarding the NIH GTR can be found at: https://www.ncbi.nlm.nih.gov/gtr/

When multiple molecular biomarkers are tested on the same date of service it is considered to be a multianalyte panel and requires reporting with a single CPT code. The appropriate genomic sequencing procedure (GSP) code or Proprietary Laboratory Analysis (PLA) code should be submitted when multi-gene testing is performed instead of submitting the individual Tier 1 and Tier 2 codes. When a GSP or PLA does not describe the multianalyte testing performed, the unlisted CPT code 81479 may be reported to encompass all testing performed. When an unlisted CPT code is reported on the same date of service that a GSP or PLA code is reported for multianalyte testing, only one multianalyte testing code is allowed to encompass all testing performed and the GSP or PLA code will take precedence

Q&A session

Q: The testing for HPA1, HPA2, HPA3, and HPA4 was performed to rule out neonatal alloimmune thrombocytopenia. Would it be correct to report CPT codes 81105, 81106, 81107, and 81108 for this testing?

A: No, multiple molecular variants tested on the same date of service are considered a multianalyte panel and requires reporting with a single CPT code. The test panel provided should be reported with the PLA (when applicable for the provider), GSP, or other MAA multiple analyte code. In the absence of an existing code, the panel of tests provided may be registered on the NIH GTR and submitted with the unlisted CPT code 81479

Q: When would it be appropriate to report 81479?
A: It would be appropriate in the following scenarios:
• The single gene or analyte analyzed is not represented by an existing Tier 1 or Tier 2 code. If the analyte is not listed in the Tier 1 descriptor or under one of the Tier 2 codes, 81479 should be used.
• Multiple gene variants were analyzed in a single test panel and there is not an appropriate PLA, GSP, or other MAA test code to report .

Q: When would it be appropriate to report more than one CPT code 81479 on a single date of service?
A: From a CPT coding perspective, code 81479, unlisted molecular pathology procedure, should only be reported once per patient, per specimen and date of service to identify the services provided because it does not identify a specific service. When registering more than one CPT code 81479 on the NIH GTR, the appropriate specimen type may be selected (i.e. amniotic fluid, bone marrow, fresh tissue, saliva, urine, etc.) Each CPT code 81479 reported should be listed on separate claim lines with their respective GTR ID. In addition, if requested, the patient records should support that different specimens were tested.

Q: Is it appropriate to report multiple codes using a modifier 59 when different methodologies and genes are tested on a single specimen?
A: Testing on a single specimen should be reported with a single code (Tier 1, Tier 2, PLA, GSP, or when no other code is applicable, the unlisted code 81479). The code reported for the testing on the single specimen includes testing by all methodologies, all genes and analytes, all components (specimen preparation, DNA/RNA quantification, etc.) and all analytical services performed for the test. In the rare situation that separate specimen(s) are tested on the same patient on the same date of service for distinctly separate indications, the initial specimen is reported without a modifier and an additional code may be reported with an appropriate modifier for the additional specimen tested. The use of a modifier to identify a different indication on the same date of service must be supported by the test requisition form and documentation. Per the CMS National Correct Coding policy if the single procedure is performed, only one unit of service may be reported. Modifiers should not be used to report multiple codes when a single specimen is tested.