ModifiedUnitedHealthcarePolicy CS149KS.04

Pharmacogenetic Panel Testing (for Kansas Only)

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Coverage of pharmacogenetic and pharmacogenomic testing, including multigene panels, for UnitedHealthcare Community Plan members in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicyPharmacogenetic Panel Testing (for Kansas Only)

Policy CodePolicy CS149KS.04

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionVerify applicable federal, state, or contractual benefit requirements before using this policy.

SourceLink

POLICY UPDATE CHANGES

The applicable code list was updated to add CPT code 0697U.

The clinical evidence, FDA, and references sections were updated to reflect current information.

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ModifiedUnitedHealthcarePolicy CS149KS.04

Pharmacogenetic Panel Testing (for Kansas Only)

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Coverage of pharmacogenetic and pharmacogenomic testing, including multigene panels, for UnitedHealthcare Community Plan members in Kansas.

Policy Summary

PayerUnitedHealthcare

PolicyPharmacogenetic Panel Testing (for Kansas Only)

Policy CodePolicy CS149KS.04

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionVerify applicable federal, state, or contractual benefit requirements before using this policy.

SourceLink

POLICY UPDATE CHANGES

The applicable code list was updated to add CPT code 0697U.

The clinical evidence, FDA, and references sections were updated to reflect current information.

Kansas onlyGeographic scope

5+ genesMultigene panel threshold

2External criteria sources

0697UNew applicable code

Medical Necessity and Coverage Criteria

State-Specific Criteria

For Kansas members, medical necessity for gene analysis (genetic testing) is determined according to the Kansas Medical Assistance Program requirements.

Refer to the Kansas Medical Assistance Program: Professional Fee-for-Service Provider Manual for Kansas-specific medical necessity clinical coverage criteria for gene analysis (genetic testing).

Non-State-Specific Criteria

For pharmacogenetic testing that is not subject to Kansas-specific criteria, apply the following requirements.

ALL of the following

Medical necessity is evaluated under InterQual® CP: Molecular Diagnostics, Pharmacogenomic Testing for Psychotropic Medication Drug Response.
The applicable InterQual® criteria are reviewed for the requested pharmacogenetic test and indication.

Unproven and Not Medically Necessary

The following services are considered unproven and not medically necessary because sufficient evidence of efficacy is lacking.

ANY of the following

Use of a pharmacogenetic multigene panel testing five or more genes to evaluate drug-metabolizer status, for any indication.
Use of the PrismRA® molecular signature test to evaluate the likelihood of inadequate response to anti-TNF therapies for rheumatoid arthritis.

Other Pharmacogenetic Multigene Panel Testing

Other pharmacogenetic multigene panel testing is not medically necessary when clinical efficacy has not been substantiated in the scientific literature.

ANY of the following indications or uses

Individualized therapy for multimorbidity.
Individualized therapy for polypharmacy.
Prediction or management of cancer treatment toxicity.
Medication response testing without a clinically established treatment decision.
Individualized therapy for inflammatory bowel disease (IBD).

PrismRA® Molecular Signature Testing

The evidence supporting PrismRA® is limited and insufficient to establish clinical utility.

ALL of the following apply

The requested test is the PrismRA® molecular signature test for rheumatoid arthritis.
The test is intended to predict inadequate response to anti-TNF therapy before treatment is initiated.
Available evidence is very low quality or limited, and additional larger, independent, and more diverse studies with improved study designs are needed.

Evidence-Supported Gene–Drug Relationships and Panel Limits

Coverage of pharmacogenetic testing should be limited to evidence-supported gene-drug relationships and clinically relevant treatment decisions; broad multigene panel use is not supported.

ALL of the following considerations apply

CYP2D6, CYP2C19, and/or CYP2B6 genotype results may be beneficial for identifying patients at higher risk of adverse drug reactions or inadequate response to selected SSRI therapy, based on moderate- to high-quality evidence.
CYP2D6 and CYP2C19 genotyping may support dosing of tricyclic antidepressants under applicable CPIC guidance.
Results must be interpreted with awareness that rare or untested variants, age, diet, comorbidities, smoking, pregnancy, concomitant medications, and epigenetic variation may cause the predicted phenotype to differ from the actual phenotype.
HTR2A and SLC6A4 testing does not have a CPIC clinical recommendation for SSRI antidepressant use because evidence of clinical validity and utility is mixed or insufficient.

The use of pharmacogenetic multigene panels containing five or more genes for evaluation of drug-metabolizer status is unproven and not medically necessary for any indication because sufficient evidence of efficacy is lacking.

PrismRA® testing to evaluate the likelihood of inadequate response to anti-TNF therapies for rheumatoid arthritis is excluded as unproven and not medically necessary because sufficient evidence of efficacy is lacking.

Broad pharmacogenetic multigene panel testing is not medically necessary when used for multimorbidity, polypharmacy, cancer treatment toxicity, medication response, inflammatory bowel disease, or general medication prescribing because clinical efficacy has not been substantiated.

Clinicians should avoid using pharmacogenetic testing to select psychotropic medications in children and adolescents.

HTR2A and SLC6A4 testing for SSRI antidepressant use lacks sufficient evidence of clinical validity and utility for a clinical recommendation.

FDA approval or clearance alone is not a basis for coverage. FDA status does not replace the applicable medical necessity and clinical evidence requirements.

Pharmacogenetic panels testing five or more genes to determine drug-metabolizer status are not medically necessary for any indication.

PrismRA® testing intended to predict inadequate response to anti-TNF therapy is not medically necessary because the supporting evidence is limited and insufficient to establish clinical utility.

Broad pharmacogenetic multigene panel testing is not medically necessary for multimorbidity, polypharmacy, cancer treatment toxicity, medication response, inflammatory bowel disease, or general prescribing.

Potentially Covered Testing

Gene Analysis and Pharmacogenetic Testing

Covered when medical necessity criteria are met under the applicable external criteria:

Applicable medical-necessity criteria

Selected Pharmacogenetic Testing

Selected pharmacogenetic testing may be considered when clinically indicated for medication selection or dosing:

Guideline-supported uses

Perform HLA-A and HLA-B testing before use of carbamazepine or oxcarbazepine.
Recommended in alignment with regulatory agencies and expert groups.
These tests may be most beneficial in individuals with an inadequate response or adverse reaction to a previous trial; the policy does not support widespread use of other pharmacogenetic tests.

Cancer Pain Pharmacogenetic Testing

Clinical Eligibility Requirements

For potential psychiatric use, CYP2C19 or CYP2D6 testing may be most beneficial after an inadequate response or adverse reaction to a previous antidepressant or antipsychotic trial.

Excluded Services

Services identified as not covered include pharmacogenetic multigene panels testing five or more genes for drug-metabolizer status, PrismRA testing for inadequate anti-TNF response in rheumatoid arthritis, and broad PGx multigene panel use for indications whose clinical efficacy has not been established.

Applicable Codes and Coding Parameters

Applicable CodesHCPCS

0173U	Psychiatry (i.e., depression, anxiety), genomic analysis panel, includes variant analysis of 14 genes.
0175U	Psychiatry (e.g., depression, anxiety), genomic analysis panel, variant analysis of 15 genes.
0345U	Psychiatry (e.g., depression, anxiety, attention deficit hyperactivity disorder [ADHD]), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6.
0347U	Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 16 gene report, with variant analysis and reported phenotypes.
0348U	Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 25 gene report, with variant analysis and reported phenotypes.
0349U	Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis, including reported phenotypes and impacted gene-drug interactions.
0350U	Drug metabolism or processing (multiple conditions), whole blood or buccal specimen, DNA analysis, 27 gene report, with variant analysis and reported phenotypes.
0392U	Drug metabolism (depression, anxiety, attention deficit hyperactivity disorder [ADHD]), gene-drug interactions, variant analysis of 16 genes, including deletion/duplication analysis of CYP2D6, reported as impact of gene-drug interaction for each drug.
0411U	Psychiatry (e.g., depression, anxiety, attention deficit hyperactivity disorder [ADHD]), genomic analysis panel, variant analysis of 15 genes, including deletion/duplication analysis of CYP2D6.
0419U	Neuropsychiatry (e.g., depression, anxiety), genomic sequence analysis panel, variant analysis of 13 genes, saliva or buccal swab, report of each gene phenotype.

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Applicable CPT CodesCPT

0697U

Applicable CPT code added; specific code description is not provided in this window.

Multigene Pharmacogenetic Panel

Panel thresholdFive or more genes

Testing purposeEvaluation of drug-metabolizer status

Coverage statusUnproven and not medically necessary for any indication due to insufficient evidence of efficacy

CDAI Minimal Important Difference

Assessment time point24 weeks

Moderate baseline disease activityImprovement of ≥ 6 in CDAI

High baseline disease activity

Provider Guidance and Coverage Risks

Documentation Required

Verify Governing Benefit Requirements

Before applying this policy, verify the applicable federal, state, or contractual benefit plan requirements. Those requirements govern if they conflict with this standard Medical Policy.

Review the governing benefit plan documents and requirements before determining coverage.
Use this policy with independent professional medical judgment; it does not constitute medical advice.

Denial Risk

Five-or-More-Gene Panels: Unproven

Pharmacogenetic multigene panels that evaluate five or more genes for drug-metabolizer status are unproven and not medically necessary for any indication because efficacy has not been sufficiently established.

Do not treat panel size alone as evidence of medical necessity or clinical utility.

Policy Background

Pharmacogenetics evaluates how genetic variation may affect an individual's response to medications, including potential therapeutic benefit and adverse effects. Targeted testing for a specific drug typically analyzes one gene, whereas this policy addresses multigene panels that include five or more genes.

Key Terms

Multigene Panel

DefinitionGenetic tests that typically use next-generation sequencing to test multiple genes simultaneously

Alternate terminologyMultigene test; multiple-gene panel test

Policy contextThe policy addresses multigene panels that include five or more genes

Pharmacogenetic Testing (PGx)

DefinitionTesting that uses a patient's genetic variants or phenotypes to guide medication selection, dosing, or treatment response

Related termPharmacogenomics

Clinical purpose

Policy Summary

PayerUnitedHealthcare

PolicyPharmacogenetic Panel Testing (for Kansas Only)

Policy CodePolicy CS149KS.04

Change TypeModified

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionVerify applicable federal, state, or contractual benefit requirements before using this policy.

SourceLink

On This Page

General use to guide medication prescribing.

The VA/DoD guideline found insufficient evidence to recommend for or against PGx testing to guide antidepressant selection in major depressive disorder.

No existing CPIC guideline recommends use of a multigene panel that includes five or more genes.

Pharmacogenetic testing may be considered in the following cancer-pain setting:

Improvement of ≥ 12 in CDAI

PrismRA Poor-Response Score

PrismRA thresholdScore of ≥ 11.8

Risk classificationHigh or very-high likelihood of poor response or nonresponse to anti-TNF treatment

Modeled outcomeThe PrismRA-guided strategy predicted 57% ACR50 achievement within 12 months versus 44% with the conventional strategy

Coverage is not supported solely because a panel evaluates multiple drug-metabolizer genes.

Denial Risk

PrismRA: Unproven

PrismRA testing is unproven and not medically necessary for evaluating the likelihood of inadequate response to anti-TNF therapies in rheumatoid arthritis because sufficient evidence of efficacy is lacking.

Do not represent PrismRA as an established basis for selecting initial anti-TNF therapy.
Coverage is not supported for this use under the policy.

Denial Risk

Insufficient Evidence for Broad Multigene Panel Use

Evidence is insufficient to support broad pharmacogenetic multigene panel use for individualized therapy or general prescribing decisions. Clinical efficacy has not been substantiated for the listed applications.

Multimorbidity or polypharmacy.
Cancer treatment toxicity.
Medication response.
Inflammatory bowel disease (IBD).
General use with medication prescription.

Note

Limited Evidence for PrismRA

The evidence supporting PrismRA remains limited and very low quality. Additional larger, independent, and more diverse studies with improved study designs are needed to establish clinical utility.

The current evidence rating is unlikely to change based on the newer studies evaluated in the 2025 assessment update.
Previously published analyses may not reflect the current version of the test.

Denial Risk

Broad Multigene Panels: Coverage Risk

Broad multigene panels used to guide individualized therapies remain unsupported when clinical efficacy has not been established in the scientific literature.

Apply coverage scrutiny to broad panels proposed for multimorbidity, polypharmacy, cancer treatment toxicity, medication response, IBD, or general medication prescribing.
Do not infer medical necessity from the availability of a commercial panel or from an individualized-treatment rationale alone.

Billing Rule

Panel Size or FDA Status Does Not Establish Coverage

Panel size or FDA status alone does not establish coverage. No existing CPIC guideline provides recommendations for multigene panels that include five or more genes, and FDA approval or clearance does not by itself establish medical necessity or coverage.

CPIC recommendations for selected individual genes or gene-drug relationships should not be generalized to five-or-more-gene panels.
Assess the specific indication, evidence of clinical utility, and applicable benefit requirements.

Billing Rule

FDA Status Alone Is Not a Coverage Basis

FDA approval or clearance is informational and is not, by itself, a basis for coverage under this policy.

Do not approve coverage solely because a pharmacogenetic test or companion diagnostic has FDA approval or clearance.
Review the applicable benefit plan terms and policy requirements separately from FDA regulatory status.

To guide treatment strategies, clinical evaluations, and decisions based on the predicted response to treatment in particular clinical contexts

PrismRA

Test typeMolecular signature test

Gene-expression componentEvaluates 19 gene-expression features

Additional componentsAnticitrullinated protein and three clinical metrics: sex, body mass index, and patient disease assessment

Clinical purposeEstimates the likelihood of inadequate response to anti-TNF therapy in rheumatoid arthritis