CPT Code and Description
81479 Unlisted Molecular Pathology Procedure
Overview
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.
Reimbursement Guidelines
According to the American Medical Association (AMA) molecular pathology procedure code selection is typically based on the specific gene(s) that is being analyzed. Genes are described using Human Genome Organization (HUGO) approved gene names and are italicized in the code descriptors. Gene names were taken from tables of the HUGO Gene Nomenclature Committee (HGNC) at the time the CPT codes were developed. The AMA has provided Claim Designations using these abbreviated gene names and/or analytes. These Claim Designations are cross walked to the appropriate codes to report on the Molecular Pathology Gene Table provided in the Pathology and Laboratory section of the AMA CPT codebook.
Codes that describe tests to assess for the presence of gene variants use common gene variant names. Typically, all of the listed variants would be tested. However, these lists are not exclusive. If other variants are also tested in the analysis, they would be included in the procedure and not reported separately. The molecular pathology codes include all analytical services performed in the test (eg, cell lysis, nucleic acid stabilization, extraction, digestion, amplification, and detection).
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.
Tier 2 molecular pathology codes are used to report procedures not listed in Tier 1 molecular pathology codes. They are arranged by level of technical resources and interpretive work by the physician or other qualified health care professional. Each Tier 2 code lists the specific analytes associated with the procedure code level. The Tier 2 code reported must have the specific analyte listed under the code or is a code match to the Claim Designation on the AMA Molecular Pathology Gene Table. In order to identify the analyte being tested under the code submitted, an appropriate Claim Designation code or Abbreviated Gene Name must be submitted on the claim. This information should be submitted in field 2400 SV101-7 in the electronic claim form or in the shaded area of the service line in section 24 on a paper claim form. In order to identify the information, a ZZ qualifier is required to be placed without a space or hyphen in front of the Claim Designation code or Abbreviated Gene Name (example: ZZCLRN1).
Genomic sequencing procedures (GSPs) and other molecular multianalyte assays codes should be used when the components of the descriptor(s) are fulfilled regardless of the technique used to provide the analysis, unless specifically noted in the code descriptor. When a GSP assay includes gene(s) that is listed in more than one code descriptor, the code for the most specific test for the primary disorder sought should be reported, rather than reporting multiple codes for the same gene(s).
In addition to Tier 1, Tier 2 and GSP procedure codes, the AMA created Proprietary Laboratory Analysis (PLA) codes. Other CPT code(s), including unlisted codes, should not be used to report single or multianalyte services that may be reported with that specific PLA code. These codes encompass all analytical services required for the analysis (eg, cell lysis, nucleic acid stabilization, extraction, digestion, amplification, hybridization and detection). 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: 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.
Current Coding Scheme
As of 2013, the AMA implemented specific MoPath codes apportioned into categories of: Tier 1 (analyte specific codes), Tier 2 (level of complexity codes with specific analytes listed under each specific Tier) and MAAA (Multianalyte Assays with Algorithmic Analyses) codes. These codes were developed to provide a clearly defined system for payers to identify the specific tests they were to consider for reimbursement and the analyte, technological and methodological components involved in those tests.
At times, Tier 1 or Tier 2 codes may not suitably describe biomarkers or analytes, or may not adequately represent the particular assay or testing performed; therefore code 81479 – Unlisted Molecular Pathology Procedure (Not Otherwise Classified “NOC” / miscellaneous ) was established for utilization and billing purposes. When considering appropriate codes to bill, laboratories should keep in mind that coding must reflect the analyte, methodology, and technology utilized in the particular assay or test.
All genomic sequencing procedures and molecular multianalyte assays (e.g., CPT codes 81410-81471), many multianalyte assays with algorithmic analyses (e.g., CPT codes 81493-81599, 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 physician 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.
Tumor Marker Genetic Assays:
a. Moda Health considers the following tumor markers medically necessary if 1 or more of the following:
i. Gene expression assays for breast cancer risk stratification for 1 or more of the following per primary breast tumor:
- Endopredict (81522) – risk stratification for breast cancer staging refer to MCG A-0532 Breast Cancer Gene Expression Assays.
- Oncotype DX for Breast Cancer assay (81519) – risk stratification for breast cancer staging refer to MCG A-0532 Breast Cancer Gene Expression Assays.
- Mammaprint 70 gene breast assay (81521) – refer to MCG A-0532 Breast Cancer Gene Expression Assays
ii. Breast Cancer Index (81518) for continuation of endocrine therapy refer to Noridian LCD 37824; A57774
iii. Decision DX-UM (Uveal Melanoma) – risk stratification for uveal (eye) melanoma refer to Noridian LCD 37072
iv. Prolaris Prostate Cancer Genomic Assay (81541) – refer to Moda Health Medical Necessity Criteria for Prostate Cancer Genomic Assay (HCS-0225)
v. Myriad Integrated BRAC Analysis with my Risk (81479) BRCA1 and 2 – refer to MCG A0499 Breast and Ovarian Cancer, Hereditary
vi. Myriad Colaris with my Risk – colon cancer (81479) – refer to MCG A-0533 Lynch Syndrome
Codes Description
81479 Unlisted molecular pathology procedure
What do you do if your genes/analytes are not listed?
• 81479
• You cannot self assign
• You cannot use multiples of 81479
• Submit a coding change proposal (CCP)
Genetic Testing: Cancer Management
These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.
Administrative Process
The scope of this coverage policy includes, but is not limited to, these methods of genetic testing for cancer management:
• Section 1: Transplant-related testing for chimerism.
• Section 2: Targeted testing related to hematological malignancies, lymphoproliferative disorders, and myelodysplastic / myeloproliferative conditions;
• Section 3: Other single-gene testing, targeted multiple-gene testing, microsatellite instability (MSI) testing, mismatch repair (MMR) testing;
• Section 4: Other genetic and molecular tests for cancer management, including multiple gene panels, gene expression classifiers, next generation sequencing assays, and all other methods of genetic or molecular biomarker testing related to cancer management.
Coverage of medications, immunohistochemistry (IHC) testing, cytogenetic and related testing, human leukocyte antigen (HLA) typing, and genetic testing for hereditary cancer syndromes is outside the scope of this coverage policy.
Tests that Do Not Require Prior Authorization
Prior authorization is not required for certain common types of genetic testing for cancer management. This includes:
• Transplant-related testing for chimerism, when it is associated with both:
- A primary diagnosis from the attached list.
- A procedure code from the attached list.
• Targeted testing related to hematological malignancies, lymphoproliferative disorders, and myelodysplastic / myeloproliferative conditions, when it is associated with both: - A primary diagnosis from the attached list.
- A procedure code from the attached list.
These services are not covered for any other diagnoses.
Please check with Member Services for information regarding specific coverage for these services.
Tests that Require Prior Authorization.
Prior authorization is required for the following services:
• Single-gene testing, targeted multiple-gene testing, micro satellite instability (MSI) testing, and mismatch repair (MMR) testing, except for targeted testing as described above.
• Other genetic and molecular tests for cancer management, including multiple gene panels, gene expression classifiers, next generation sequencing assays, and all other methods of genetic or molecular biomarker testing related to cancer management.
• Testing that is associated with a procedure code listed in “Box A”, below.
Tests that require prior authorization will be reviewed for medical necessity of the testing as a whole. That is, a single coverage decision will apply to all of the tests, services, and/or procedure codes associated with the genetic test, whether they are requested/billed together or separately.
Box A: Genetic testing procedure codes that require prior authorization Molecular pathology procedures, Tier 2 or unlisted (CPT 81400-81408, 81479).
