Concert Genetic Testing: Immunology and Rheumatology
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Defines medical necessity criteria and coding implications for genetic and molecular tests used to evaluate autoimmune, immune deficiency, periodic fever syndromes, and rheumatoid arthritis in immunology and rheumatology patients.
Rheumatoid Arthritis TNFi Treatment Response Algorithmic Tests coverage status changed from non-covered to covered based on LCD guidelines.
HLA Typing for Axial Spondyloarthritis criteria: removed requirement that HLA-B27 results be used to establish diagnosis and reworded criteria for clarity.
Policy title changed from 'Concert Genetic Testing: Immune, Autoimmune, and Rheumatoid Disorders' to 'Concert Genetic Testing: Immunology and Rheumatology'.
Added CPT codes 81401-81407 to the Policy Reference Table for Other Covered Immune, Autoimmune, and Rheumatoid Disorders.
Coverage Criteria: Immunology & Rheumatology Testing
HLA-DQ Genotyping Analysis
Covered when ALL of the following are met
Guideline support: ACG and AGA note HLA testing useful in serology–histology discrepancies and prior gluten-free diet.
HLA Typing for Axial Spondyloarthritis
Covered when ALL of the following are met
HLA-B27 is an adjunctive test; positive results increase probability of axSpA but are not diagnostic alone and must be interpreted with imaging and clinical features.
Periodic Fever Syndromes Multigene Panel
Covered when ALL of the following are met
Consider multigene autoinflammatory panel after exclusion of common causes per Soon and Laxer 2017.
Evidence-Based Rheumatoid Arthritis Algorithmic Tests (PrismRA)
Covered when ALL of the following are met
PrismRA is considered evidence-based for guiding TNFi selection when these criteria are met; documentation of prior csDMARD therapy and intolerance/nonresponse required.
Emerging Evidence Rheumatoid Arthritis Algorithmic Tests (Vectra)
See policy not medically necessary statement.
Other Covered Immune, Autoimmune, and Rheumatoid Disorders
Covered when ALL of the following are met
Testing for other disorders not specifically listed will be evaluated per the General Approach to Genetic and Molecular Testing policy; condition list is not comprehensive.
Rheumatoid Arthritis: Targeted Therapy Selection
CMS LCD L39424 guidance for targeted therapy selection in RA states covered when ALL of the following are met:
From CMS LCD L39424; aligns with coverage change to include RA TNFi algorithmic testing under specified conditions.
HLA Typing for Axial Spondyloarthritis
HLA-B27 testing utility for axial spondyloarthritis:
Supported by ASAS criteria and UpToDate.
Periodic Fever Syndromes
Periodic Fever Syndromes multigene panel:
Definition and recommendations from Soon and Laxer 2017; unexplained fever defined per FUO criteria.
Current evidence supports the genetic and molecular tests listed in this policy only for the specific clinical indications detailed in each criteria set. For example, HLA‑DQA1/DQB1 genotyping is considered medically necessary to evaluate for celiac disease only when the member is being evaluated for celiac disease and has either inconclusive serology or histology or has started a gluten‑free diet prior to evaluation, and testing has not previously been performed; it is not supported for other indications. Similarly, HLA‑B27 typing, periodic fever multigene panels, and rheumatoid arthritis algorithmic tests (PrismRA) have defined, limited indications in this policy and are not supported outside those specified criteria. Providers should therefore document the specific clinical criteria that apply to the requested test.
Requests for known familial variant analysis are no longer processed under this policy. Criteria and routing for testing that targets a known familial variant have been moved to the separate policy Genetic Testing: General Approach to Genetic and Molecular Testing. Failure to follow that policy for familial variant testing may result in denial; providers should submit such requests per the General Approach policy and include the required clinical documentation.
Rheumatoid arthritis algorithmic tests based on the Vectra/MBDA platform are not supported by current evidence. The policy states that Vectra does not have demonstrated clinical validity and utility for guiding RA therapy selection and is considered not medically necessary outside of research or settings with convincing new evidence.
There is insufficient evidence to support the use of the leptin‑adjusted Vectra (the adjusted MBDA score) to guide rheumatoid arthritis treatment decisions. Although earlier versions of the MBDA score appear in some disease activity measure lists, the currently marketed, leptin‑adjusted MBDA has not been shown to have adequate evidence for guiding therapy and Concert notes no professional guideline recommendations endorsing it for treatment selection.
Coding and Billing Information
| 81374 | HLA-B27 DNA typing (listed) |
| M04.8 | Other specified systemic involvement of connective tissue (listed) |
| M04.9 | Systemic involvement of connective tissue, unspecified (listed) |
| M05 | Rheumatoid arthritis with rheumatoid factor (listed) |
| M06 | Other rheumatoid arthritis (listed) |
| M45 | Ankylosing spondylitis (listed) |
| 0456U | PLA code added for Rheumatoid Arthritis TNFi Treatment Response Algorithmic Tests |
Provider Actions & Documentation Requirements
Code-linked prior authorization
Prior authorization may be required for genetic/molecular tests and must reference the specific CPT or CPT-family code(s) for the requested test as listed in the policy tables at time of submission.
- Use the exact CPT/CPT®-family code(s) that correspond to the test when requesting prior authorization.
- Codes shown in the policy are informational; always confirm current coding guidance before submission.
Reference-table test codes must be documented
Document the specific test code(s from the Policy Reference Table when ordering or billing (examples include CPT 81401–81407, 81404, 81479 and PLA 0456U) and record the clinical rationale linking the code to the medical necessity criteria.
- Include the Policy Reference Table CPT/PLA codes on the request or claim.
- State the clinical indication that meets the policy criteria (e.g., recurrent fevers, inconclusive celiac serology/histology, RA treatment decision).
Therapy prerequisites for PrismRA (algorithmic test)
For PrismRA (PLA 0456U) testing, include documentation that the member is age ≥18 and has previously received first-line conventional synthetic DMARD (csDMARD) therapy with intolerance or inadequate response at therapeutic doses prior to using the algorithmic test to guide TNFi selection.
- Confirm age ≥18 on documentation.
- Record prior csDMARD therapy, dosing adequacy, and evidence of intolerance or lack of response.
Required clinical documentation linking test to policy criteria
Document the exact clinical indication and how the member meets the policy criteria for the requested test (e.g., inconclusive celiac serology or histology or initiation of gluten‑free diet prior to evaluation for HLA‑DQ; ≥3 unexplained fevers in 6 months with common causes excluded for periodic fever panels; age, csDMARD history, and intolerance/nonresponse for PrismRA).
- Tie the requested CPT/PLA code to the specific policy criterion met by the patient.
- Include prior test results, imaging, treatment history, and exclusion of common causes where applicable.
Coding and clinical rationale must be included
Providers should document the specific CPT codes (for example, newly added CPT 81401–81407) and PLA 0456U when applicable, and include the clinical rationale that demonstrates how the member meets the policy criteria per the Policy Reference Table.
- List the test CPT/PLA code on the authorization or claim.
- Provide supporting clinical notes that reference the policy criteria used to justify medical necessity.
Coding inclusion does not guarantee coverage
Inclusion of a CPT or PLA code in the Policy Reference Table (or its absence) does not by itself guarantee payment; providers must verify current coding guidance and payer coverage prior to claim submission.
- Codes in the policy are informational and not exhaustive.
- Confirm up-to-date professional coding guidance before billing.
Known familial variant testing routed to separate policy
Requests for known familial variant analysis have been routed to the separate policy “Genetic Testing: General Approach to Genetic and Molecular Testing”; failure to follow that routing may result in denial.
- Do not submit known familial variant analysis under this policy—use the General Approach policy.
- Refer to the alternate policy for applicable criteria and submission requirements.
Background and Scope
Genetic testing can be diagnostically useful in several immunology and rheumatology conditions when applied to the situations specified in this policy. Examples include: HLA‑DQA1/DQB1 genotyping to help rule out celiac disease when serology or biopsy is inconclusive or after a prior gluten‑free diet; HLA‑B27 typing as an adjunctive test when clinical or imaging features suggest axial spondyloarthritis; and multigene panels for hereditary recurrent fever syndromes when the member has ≥3 unexplained fever episodes in 6 months (each ≥7 days apart) and common causes have been excluded. The policy also aligns select algorithmic tests (PrismRA) with evidence‑based criteria for targeted therapy selection while excluding tests without sufficient evidence.
Definitions
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