ModifiedColorado Rocky Mountain Health PlansPolicy 2026T0587Z

Pharmacogenetic Panel Testing

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This policy governs coverage of pharmacogenetic multigene panels and the PrismRA molecular signature test for UnitedHealthcare Commercial and Individual Exchange benefit plans. It addresses testing used to evaluate drug-metabolizer status or predict response to anti-TNF therapy in rheumatoid arthritis.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPharmacogenetic Panel Testing

Policy CodePolicy 2026T0587Z

Change TypeQuarterly code update

Effective DateOct 1, 2026

Next Review DateN/A

Key ActionCoverage is denied for pharmacogenetic multigene panels involving five or more genes used to evaluate drug-metabolizer status.

SourceLink

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ModifiedColorado Rocky Mountain Health PlansPolicy 2026T0587Z

Pharmacogenetic Panel Testing

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Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPharmacogenetic Panel Testing

Policy CodePolicy 2026T0587Z

Change TypeQuarterly code update

Effective DateOct 1, 2026

Next Review DateN/A

Key ActionCoverage is denied for pharmacogenetic multigene panels involving five or more genes used to evaluate drug-metabolizer status.

SourceLink

Coverage Criteria

Multigene panels for drug-metabolizer status

Not medically necessary for any indication.

Pharmacogenetic multigene panel testing: The use of pharmacogenetic multigene panels involving five or more genes for evaluation of drug-metabolizer status is unproven and not medically necessary for any indication due to insufficient evidence of efficacy.five or more genes

PrismRA testing for rheumatoid arthritis

Not medically necessary.

PrismRA molecular signature test: The use of the PrismRA molecular signature test is unproven and not medically necessary for evaluating the likelihood of inadequate response to anti-TNF therapies for rheumatoid arthritis due to insufficient evidence of efficacy.

Cardiovascular disease

Evidence regarding multigene PGx testing for cardiovascular disease is limited.

Cardiovascular disease evidence limitation: High-quality studies demonstrating improved outcomes from PGx testing in individuals with cardiac conditions or undergoing cardiac interventions are required.

Available studies include simulations and observational claims analyses; real-world testing did not appear to improve outcomes in one claims analysis.

Anthracycline-induced cardiotoxicity

Routine PGx panel testing for chemotherapy-induced cardiotoxicity is not supported at this time.

Anthracycline cardiotoxicity evidence limitation: Additional prospective studies with long-term follow-up are needed to validate the role of PGx testing in assessing chemotherapy-induced cardiotoxicity risk.

Evidence is heterogeneous, genetically and clinically variable, and generally has very low certainty; robust, ethnically diverse studies are needed before widespread adoption.

Pain management

Multigene PGx testing for pain management is not currently supported as safe or efficacious.

Pain-management evidence limitation: Current evidence does not establish that multigene PGx testing safely or effectively predicts opioid response, side effects, dependence, or overall treatment outcomes.

Some trials reported favorable outcomes, but studies were small or heterogeneous, had limited adverse-event data or follow-up, and require confirmation in larger, more rigorous populations.

Psychiatric indications

Psychiatric PGx studies report some improvements in response or remission, but the evidence is mixed.

Psychiatric indication evidence limitation: Reported benefits of PGx-guided psychiatric treatment are not consistently demonstrated on primary outcomes and require interpretation in light of study design and outcome limitations.

One randomized study found no difference in the primary week-8 symptom-improvement outcome despite later differences in response and remission; other findings include small or inadequately powered studies.

Pharmacogenetic multigene panels involving five or more genes for evaluation of drug-metabolizer status are excluded as unproven and not medically necessary for any indication because evidence of efficacy is insufficient.

The PrismRA molecular signature test for evaluating the likelihood of inadequate response to anti-TNF therapies in rheumatoid arthritis is excluded as unproven and not medically necessary because evidence of efficacy is insufficient.

Multigene pharmacogenetic testing for predicting pain-treatment response, side effects, dependence, or improving overall treatment outcomes is not supported as safe or efficacious in the peer-reviewed literature.

Routine pharmacogenetic panel testing to assess the risk of chemotherapy-induced cardiotoxicity is not supported by the evidence at this time.

Pharmacogenetic multigene panels involving five or more genes used to evaluate drug-metabolizer status are not medically necessary for any indication because evidence of efficacy is insufficient.

PrismRA testing used to evaluate the likelihood of inadequate response to anti-TNF therapies for rheumatoid arthritis is not medically necessary because evidence of efficacy is insufficient.

Applicable Codes and Definitions

Applicable CodesCPT

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.
0392U	Drug metabolism (depression, anxiety, attention deficit hyperactivity disorder [ADHD]), gene-drug interactions, variant analysis of 16 genes, including deletion/duplication analysis of CYP2D6.
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.
0434U	Drug metabolism (adverse drug reactions and drug response), genomic analysis panel, variant analysis of 25 genes with reported phenotypes.
0460U	Oncology, whole blood or buccal, DNA single-nucleotide polymorphism (SNP) genotyping by real-time PCR of 24 genes, with variant analysis and reported phenotypes.

Applicable CodesCPT

0533U	Drug metabolism, whole blood, pharmacogenomic genotyping of 40 genes and CYP2D6 copy number variant analysis, reported as metabolizer status.
0650U	Drug metabolism (adverse drug reactions and drug response), genotyping of 16 genes (i.e., ABCG2, CYP2B6, CYP2C9, CYP2C19, CYP2C, CYP2D6, CYP3A5, CYP4F2, DPYD, G6PD, GGCX, NUDT15, SLCO1B1, TPMT, UGT1A1, VKORC1), reported as metabolizer status and transporter function.
0652U	Drug metabolism (adverse drug reactions and drug response), genotyping of 9 genes (i.e., CYP2D6, CYP2C19, G6PD, SLCO1B1, HLA-B*58:01, NAT2, CYP2C9, VKORC1, ABCG2), reported as metabolizer status and transporter function.
0697U	Obesity, DNA genotyping, analysis of up to 41 genes, buccal swab or blood specimen, patient biometrics, risk-score algorithm to identify a predisposition to up to 4 phenotypes.

Applicable CodesCPT

81418	Drug metabolism (e.g., pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis.
81479	Unlisted molecular pathology procedure.

Applicable CPT CodesCPT

0697U

Supporting Information

Multigene pharmacogenetic panel

Test typePharmacogenetic multigene panel

Definition thresholdFive or more genes

Primary use describedEvaluation of drug-metabolizer status and possible response to many drugs

Provider and Coverage Actions

Denial Risk

Multigene Pharmacogenetic Panels Not Medically Necessary

Multigene pharmacogenetic panels involving five or more genes are unproven and not medically necessary for any indication because evidence of efficacy is insufficient. Do not represent these panels as medically necessary for coverage.

Applies to panels used to evaluate drug-metabolizer status.
Five-or-more-gene panels are subject to this denial position.

Denial Risk

PrismRA Testing Not Medically Necessary

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

Indication addressed: rheumatoid arthritis anti-TNF response.

Background

Pharmacogenetics, also called pharmacogenomics, evaluates how genetic variation may affect an individual's response to medications, including potential treatment benefit and adverse effects. Targeted testing for a specific drug generally analyzes one gene, whereas this policy addresses multigene panels that proactively assess possible responses to multiple drugs.

Definitions

Multigene Panel

DefinitionA genetic test that tests multiple genes simultaneously

Typical technologyNext-generation sequencing

Also calledMultigene test, multiple-gene panel test, or multiple-gene test

TAU

AbbreviationTAU

MeaningTreatment as usual or usual care

Treatment basisThe treating provider’s clinical experience and knowledge rather than PGx-guided treatment

Not Covered Services

The following services are not covered: pharmacogenetic multigene panels involving five or more genes for evaluation of drug-metabolizer status, for any indication; and the PrismRA molecular signature test for evaluating the likelihood of inadequate response to anti-TNF therapies in rheumatoid arthritis.