ModifiedCommunity Health Plan WashingtonPolicy N/A

Concert Genetic Testing: Immunology and Rheumatology

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Defines medical necessity criteria and coding considerations for genetic and genomic tests used to evaluate autoimmune, immune deficiency, periodic fever syndromes, and rheumatoid arthritis in the immunology/rheumatology setting; applies to members of Community Health Plan Washington through Centene-affiliated plans.

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ModifiedCommunity Health Plan WashingtonPolicy N/A

Concert Genetic Testing: Immunology and Rheumatology

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Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert Genetic Testing: Immunology and Rheumatology

Policy CodePolicy N/A

Change TypeCoverage and criteria revisions (including PLA 0456U addition)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization when ordering listed genetic tests and document clinical criteria (e.g., fever episode counts, prior csDMARD use for PrismRA, or serology/histology context for HLA-DQ).

SourceLink

POLICY UPDATE CHANGES

Rheumatoid Arthritis TNFi Treatment Response Algorithmic Tests: Coverage status changed from non-covered to covered based on LCD guidelines.

HLA Typing for Axial Spondyloarthritis: Removed criterion requiring HLA-B27 results to establish a diagnosis and reworded criteria for clarity.

Known Familial Variant Analysis criteria were moved to a consolidated policy 'Genetic Testing: General Approach to Genetic and Molecular Testing'.

Policy title changed to 'Concert Genetic Testing: Immunology and Rheumatology'.

≥4named test groups with criteria

3+fever episode threshold

≥18PrismRA minimum age

0456UPLA code added

yesexample CPT codes listed

Medical Necessity Criteria

HLA-DQ Genotyping Analysis

HLA-DQ genotyping analysis is considered medically necessary when ALL of the following are met:

HLA-DQ genotyping criteria: A. The member/enrollee is being evaluated for celiac disease (CD); B. The member/enrollee meets at least one of the following: (1) had an inconclusive serology (antibody) result, OR (2) had an inconclusive histology (biopsy) result, OR (3) started a gluten-free diet before evaluation for celiac disease; C. HLA-DQA1 and HLA-DQB1 genotyping analysis has not been previously performed.

HLA Typing for Axial Spondyloarthritis

HLA-B27 typing is considered medically necessary when ALL of the following are met:

HLA-B27 typing criteria: A. The member/enrollee has clinical or radiographic features of axial spondyloarthritis.

Periodic Fever Syndromes Multigene Panel

Periodic fever syndromes multigene panel is considered medically necessary when ALL of the following are met:

Periodic fever panel criteria: A. The member/enrollee has three or more episodes of unexplained fever in a six-month period occurring at least seven days apart; B. Common causes of fever (including viral or bacterial infection) have been ruled out.

Evidence-Based Rheumatoid Arthritis Algorithmic Tests (PrismRA)

Evidence-based rheumatoid arthritis algorithmic tests (PrismRA) are considered medically necessary when ALL of the following are met:

PrismRA criteria: A. The member/enrollee is age 18 or older; B. The member/enrollee has a diagnosis of moderately to severely active rheumatoid arthritis (RA); C. The member/enrollee previously received first-line therapy with a conventional synthetic DMARD (csDMARD); D. The member/enrollee is unresponsive/refractory or intolerant to that therapy despite therapeutic dosing; E. One of the following: (1) has not yet initiated a biologic or targeted synthetic therapy (b/tDMARD), OR (2) has initiated a b/tDMARD and is unresponsive/refractory or intolerant to a therapeutic dose; F. The member/enrollee has not had prior molecular biomarker testing for predictive therapy selection for RA.

Emerging Evidence Rheumatoid Arthritis Algorithmic Tests

Emerging RA algorithmic tests: Current evidence does not support rheumatoid arthritis algorithmic tests (Vectra).

Other Covered Immune, Autoimmune, and Rheumatoid Disorders

Other immune, autoimmune, and rheumatoid disorders with known genetic associations may be covered when ALL of the following are met:

Other rare immune disorder testing: A. Genetic testing is to establish or confirm a diagnosis of a listed disorder (examples include: BTK for X-linked agammaglobulinemia; FAS for ALPS; CYBA/CYBC1/NCF1/NCF2/NCF4/CYBB for CGD; complement deficiencies; ELANE/HAX1 for congenital neutropenia; PRF1/STX11/STXBP2/UNC13D for HLH; STAT3 for HIES; CD40LG for Hyper IgM; CD18/Kindlin-3/ITGB2 for LAD; NEMO/IKKG; IL2RG for SCID; CXCR4 for WHIM; WAS for Wiskott-Aldrich); B. The member/enrollee demonstrates clinical features consistent with the disorder.

Rheumatoid Arthritis Algorithmic Tests (LCD-based)

Key coverage logic and prerequisites as referenced in the document:

RA algorithmic testing per LCD: Patient is an adult with confirmed moderately to severely active RA AND has history of failure, contraindication, or intolerance to at least one csDMARD despite adequate dosing AND either has not initiated a biologic/targeted synthetic DMARD (b/tDMARD) OR is being considered for an alternate class of targeted therapy because of failure, contraindication, or intolerance to the initial targeted therapy despite adequate dosing.

Based on CMS LCD L39424

HLA Typing for Axial Spondyloarthritis

HLA-B27 testing supportive context

HLA-B27 testing utility: HLA-B27 testing can increase the probability of axial spondyloarthritis (axSpA) to 80–90% when imaging is consistent with axSpA, or be used in patients with chronic back pain who have a significant pretest probability after clinical evaluation; results are not diagnostic alone and must be interpreted with clinical and imaging findings.

Periodic Fever Syndromes Multigene Panel

Periodic fever (autoinflammatory) testing context

Consider autoinflammatory genetic testing: Recurrent/unexplained fevers (>=3 episodes in 6 months, occurring at least 7 days apart) after ruling out infections, immunodeficiency, malignancy, inflammatory bowel disease, and adverse drug reactions may prompt consideration of autoinflammatory disease testing, including periodic fever multigene panels.

Based on Soon & Laxer 2017

Current evidence supports coverage of specific genetic and algorithmic tests only when the policy's clinical criteria are met. Testing is limited to the indications expressly listed (for example, HLA-DQA1/HLA-DQB1 genotyping for selected celiac disease evaluations, HLA-B27 typing in patients with clinical or radiographic features of axial spondyloarthritis, periodic fever multigene panels for recurrent unexplained fevers, and evidence-based RA algorithmic tests such as PrismRA under defined conditions). Tests ordered outside of these specified indications are not supported by current evidence and may be denied unless documentation demonstrates the policy criteria are satisfied.

The list of named conditions for which single-gene or targeted testing may be covered is illustrative, not exhaustive. The policy explicitly notes that the condition list for 'Other Covered Immune, Autoimmune, and Rheumatoid Disorders' is not intended to be comprehensive, and items such as Common Variable Immune Deficiency (CVID) were removed for brevity during the most recent revision. Coverage decisions rely on the clinical criteria in the policy rather than membership of a condition on the example list.

Rheumatoid arthritis algorithmic tests marketed as Vectra (the multibiomarker disease activity score, including updated leptin-adjusted versions) are not supported by current evidence for the uses described in this policy. The policy states that available evidence does not support Vectra testing for routine clinical decision-making in RA and therefore lists it as unsupported.

There is insufficient evidence to support the use of the adjusted MBDA (leptin‑adjusted Vectra) score to guide routine treatment decisions in rheumatoid arthritis. The document notes that published evidence on the adjusted MBDA postdates guideline reviews and that Concert identified no professional society recommendations endorsing adjusted MBDA for treatment guidance; as a result, this specific adjusted MBDA testing approach is considered unsupported by current evidence.

CPT / PLA / Related Codes

HLA-DQ / celiac-related codesmixed

81375	HLA-DQ related CPT (listed for HLA-DQ genotyping analysis)
81376	HLA-DQ related CPT
81377	HLA-DQ related CPT
81382	HLA typing CPT
81383	HLA typing CPT
K90.0	Celiac disease ICD-10
R10.0-R10.13	Abdominal pain codes range
R10.3-R10.829	Abdominal pain codes range
R10.84-R10.9	Abdominal pain codes range

HLA-B27 / axial spondyloarthritis codesmixed

81374	HLA-B27 typing CPT
M04.8	ICD-10 for certain inflammatory arthropathies
M04.9	ICD-10 for inflammatory polyarthropathy
M05	Rheumatoid arthritis with rheumatoid factor
M06	Other rheumatoid arthritis
M45	Ankylosing spondylitis

Periodic fever syndromes panel codesmixed

81404	Molecular pathology multi-gene panel CPT (listed for periodic fever panels)
81479	Unlisted molecular pathology procedure
M04.1	Periodic fever syndromes / autoinflammatory disease code
R50.9	Fever, unspecified
A68.9	Certain arthropod-borne fever (listed in document)

Rheumatoid arthritis algorithmic testsmixed

0456U	PrismRA algorithmic test (listed as evidence-based RA algorithmic test)
81490	Vectra test CPT (listed under emerging evidence)
M05	Rheumatoid arthritis with rheumatoid factor
M06.00-M06.9	Other rheumatoid arthritis range

Other covered immune/genetic testing CPTs (documented ranges)CPT

81400	Molecular pathology CPT range
81401	Molecular pathology CPT
81402	Molecular pathology CPT
81403	Molecular pathology CPT
81404	Molecular pathology CPT
81405	Molecular pathology CPT
81406	Molecular pathology CPT
81407	Molecular pathology CPT
81408	Molecular pathology CPT

Referenced PLA codesCPT

0456U

PLA code added to Policy Reference Table

inv-20: Periodic fever episodes — threshold details (>=3 episodes in 6 months, 7+ days apart)

Threshold≥ 3 episodes of unexplained fever within a 6-month period, with episodes separated by at least 7 days

Episode spacingEach qualifying fever episode must be at least 7 days apart from the next

Time windowEpisodes must occur within a contiguous 6-month (approximately 180-day) period

inv-21: Periodic fever episode count — reminder of >= 3 episodes in 6 months

Minimum episode count>= 3 episodes in a 6-month period

Authorization, Documentation, and Step Therapy

Prior Authorization

Prior authorization required for listed genetic tests

Prior authorization is required when ordering the listed genetic tests to support medical necessity under this policy.

Applies to HLA-DQA1/HLA-DQB1 genotyping, periodic fever multigene panels, PrismRA, and other listed tests.
Use the policy criteria to justify medical necessity when submitting PA requests.

Prior Authorization

PA aligns with LCD L39424 for RA algorithmic tests

Prior authorization for rheumatoid arthritis algorithmic tests follows LCD L39424 requirements: the patient must be an adult with moderately to severely active RA and meet step-therapy prerequisites before testing.

Patient must be an adult with confirmed moderately to severely active RA.
History of failure, contraindication, or intolerance to at least one csDMARD despite adequate dosing is required.

Background and Rationale

This policy covers genetic testing used to: confirm or help exclude celiac disease via HLA-DQA1/HLA-DQB1 genotyping in select scenarios; evaluate axial spondyloarthritis with HLA-B27 typing when clinical or radiographic features are present; identify hereditary periodic fever syndromes with multigene panels when the recurrent‑fever criteria are met (≥3 unexplained episodes in 6 months); and apply evidence-based RA algorithmic testing (e.g., PrismRA) only under defined adult‑RA treatment prerequisites. Recent revisions clarified coverage stance for TNFi algorithmic tests, added PLA code 0456U to the reference table, and removed certain condition entries from example lists for brevity.

Key Definitions and Thresholds

inv-31: Periodic/recurrent fever syndromes — definition (3+ episodes in 6 months, >=7 days apart)

DefinitionThree or more episodes of unexplained fever in a six-month period, occurring at least seven days apart

Alternate termAlso called hereditary recurrent fever syndromes or autoinflammatory periodic fever syndromes

Prerequisite before testingRule out common causes including viral or bacterial infection prior to genetic panel consideration

inv-32: HLA-DQ genotyping for celiac disease — role of HLA-DQA1/HLA-DQB1 genotyping to help rule out celiac disease in select cases

PurposeHLA-DQA1 and HLA-DQB1 genotyping is used to help rule out celiac disease in select clinical situations

IndicationsConsider when serology or histology is inconclusive or the patient started a gluten-free diet prior to evaluation

Policy Summary

PayerCommunity Health Plan Washington

PolicyConcert Genetic Testing: Immunology and Rheumatology

Policy CodePolicy N/A

Change TypeCoverage and criteria revisions (including PLA 0456U addition)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

ContextApplies to unexplained/recurrent fevers considered for periodic fever syndrome genetic testing

Exclusion of other causesCommon causes (e.g., viral or bacterial infection) should be ruled out before testing

Step Therapy

PrismRA sequencing: after csDMARD failure/intolerance

PrismRA testing is indicated only after prior conventional synthetic DMARD (csDMARD) therapy and may be used to inform TNFi selection per the policy criteria.

Member must have previously received first-line csDMARD therapy and be unresponsive/refractory or intolerant despite therapeutic dosing.
Results may be used to determine appropriateness of TNFi therapy.

Step Therapy

Step therapy: csDMARD failure/intolerance required

Step therapy prerequisites require documented failure, contraindication, or intolerance to at least one first-line csDMARD before targeted therapy selection testing is allowed.

Failure/intolerance must have occurred despite adequate dosing of the csDMARD.
This step-therapy logic is required prior to initiating or changing b/tDMARD therapy per LCD-based criteria.

Documentation Required

Required clinical documentation to support criteria

Clinical documentation must be submitted to support that the member meets the specific criteria for the requested test (e.g., serology or histology results, prior gluten-free diet, fever episode counts, and prior therapies).

For HLA-DQ genotyping: document inconclusive serology OR inconclusive histology OR that the member started a gluten-free diet before evaluation.
For periodic fever panels: document >=3 unexplained fever episodes in 6 months, at least 7 days apart, and exclusion of common causes.
For PrismRA: document age ≥18, diagnosis of moderately to severely active RA, and prior csDMARD use with inadequate response or intolerance.

Documentation Required

Document medical necessity and plan applicability

Providers must document that testing aligns with the policy's medical necessity criteria; coverage remains subject to the member's plan terms, limitations, and applicable state/federal requirements.

Include supporting clinical records and prior treatment details with the PA or claim to demonstrate alignment with criteria.
Coverage decisions follow plan contracts and legal/regulatory requirements.

Denial Risk

Denial risk when clinical criteria are unmet

Tests may be denied if the member does not meet the specified clinical criteria for the requested test (for example, HLA-DQ genotyping outside listed indications; periodic fever panels without ≥3 unexplained fevers in 6 months; PrismRA without prior csDMARD and age ≥18).

HLA-DQ genotyping: denial risk if not being evaluated for celiac disease or if none of the specified conditions (inconclusive serology/histology or prior gluten-free diet) are met.
Periodic fever panel: denial risk if fewer than three unexplained fever episodes in six months or if common causes have not been ruled out.
PrismRA: denial risk if patient is under 18, lacks moderately to severely active RA diagnosis, or has not had prior csDMARD therapy.

Note

Coverage status updates for RA algorithmic tests (PLA 0456U)

Coverage status for certain algorithmic RA tests was changed from non-covered to covered based on LCD guidance; previously non-covered tests may be denied unless the policy/criteria have been updated accordingly.

PLA code 0456U was added to the Policy Reference Table to reflect the covered TNFi algorithmic test.
Verify that the test and code are recognized by the plan under the updated LCD-based criteria before submission.

Prior testingGenotyping should not have been previously performed for the same evaluation

inv-33: Periodic fever syndromes — restated definition for clarity

Restated definitionRecurrent/periodic fever = ≥3 unexplained fever episodes in 6 months, each at least 7 days apart

Clinical pathwayConsider autoinflammatory disease testing only after infections, immunodeficiency, malignancy, IBD, and drug reactions are excluded

Source guidanceDefinition supported by Soon & Laxer 2017 clinical review

inv-34: Axial spondyloarthritis (axSpA) classification arms — ASAS imaging and clinical arm descriptions

ASAS imaging armPresence of sacroiliitis on radiography or MRI PLUS at least one SpA feature

ASAS clinical armHLA-B27 positivity PLUS at least two SpA features

Interpretation noteHLA-B27 testing increases probability of axSpA when imaging is consistent; results must be interpreted with clinical and imaging findings