The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Diagnostic Tests (MDT) L36021.
Proteins are common analytes and a staple of clinical laboratory testing. Tests measuring proteins are typically found across all CPT Pathology and Laboratory code sets, except for Molecular Pathology (CPT 81105-81408), which is the general scope of the MolDX program.
With advances in laboratory testing, more complex services utilizing proteins have developed. Many of these tests are multianalyte tests that seek to measure more than the presence or absence of expression of any given protein or groups of proteins. The term “proteomics” is commonly used for such tests.
Proteomics tests are hereby defined by this contractor as those tests that seek to measure the structure, function, interactions, and compositions of proteins for the sake of understanding cellular interactions of the patient in relation to disease or therapeutic interventions. These services may include the measurement of other, non-protein analytes as part of this process. Of note, it is the interaction of proteins and other analytes that is the essential component of a proteomics test, and not the presence, structure or expression of individual proteins.
To be considered a proteomics test, a test must:
- Be a multianalyte test that includes proteins as the major or essential analytes;
- Measure the interactions between analytes, including proteins;
- Require the use of informatics (nomograms, rubrics, or algorithms) to yield a result;
- Demonstrate the clinical validity of the assay as a function of the interaction of analytes measured
A test is not considered a proteomics test if:
- The clinical validity of the test rests with the analytes measured directly and not the interactions of analytes measured as an output of the informatic approach;
- Is better defined as a genomics test, with DNA and RNA components as the majority or essential analytes measured;
- The protein analytes measured are not necessary for the clinical validity of the result
Proteomics tests as defined above must be billed with an appropriate CPT code. These may be found in the Multianalyte CPT code set or may utilize the NOC code 81599; or may be defined by a relevant PLA code.
Given the complexity of these tests and the ambiguity of services rendered, all proteomics tests in MolDX jurisdictions must register with the DEX® Diagnostics Exchange Registry and obtain a Z-Code® identifier. To determine if the submitted tests are compliant with relevant policy requirements, these tests will undergo Technical Assessment by Palmetto GBA as part of the MolDX program. This is effective 1/31/2024. MolDX is delaying enforcement for changes to reimbursement until 1/31/2025.
To report a proteomics test service, please submit the following claim information:
- Select CPT® code
- Enter 1 unit of service (UOS)
- 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
- Select the appropriate ICD-10-CM code
NOTE: When entering the DEX Z-Code® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line.
