Concert Genetic Testing: Toxicology and Pharmacogenetics (Version B)
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Defines medical necessity criteria, example tests, and coding implications for pharmacogenetic and toxicology-related genetic tests used to assess drug response, toxicity, and metabolizer status for members of Community Health Plan Washington (Centene-affiliated plans). Affects providers ordering or billing for pharmacogenetic and selected single-gene variant tests.
Multiple definitions and criteria were updated across gene variant analyses and the policy reference table; language changed and additional genes/tests and CPT codes were added.
FDA Table of Pharmacogenetic Associations recommendations were incorporated for multiple genes including HLA-B*15:02, HLA-B*57:01, TPMT/NUDT15, UGT1A1, UGT2B17, VKORC1, and NAT2.
Multiple single-gene and panel pharmacogenetic criteria and definitions were updated (examples: UGT1A1, UGT2B17, VKORC1, DPYD, HLA variants, NAT2, TPMT, NUDT15, CYP family genes) and CPT codes 0423U, 0434U, 0437U, 0438U were added to the coding reference table.
Pharmacogenetic panel testing criteria changed to require demonstrated clinical validity and added medically necessary panels and LCD-aligned indications (e.g., MDD, GAD) with age thresholds.
Warfarin Sensitivity Analysis Panels: clinical criteria were added to allow coverage of small targeted panels for this indication.
Coverage Criteria for Pharmacogenetic and Toxicology Genetic Testing
Pharmacogenetic testing coverage criteria and explanatory nodes
Pharmacogenetic testing (single-gene and panel) coverage determinations are based on specific clinical indications, test validity, and applicable gene–drug management guidance. Tests not meeting the criteria below are considered investigational or not medically necessary.
ALL of the following
- Pharmacogenetic panel tests (as listed) are considered medically necessary only when ALL of the following are met:
See enumerated list of covered panels below.
ALL of the following
- Member is age 18 years or older.
- Member is being considered for, or is currently being treated with, one or more specific medication(s) related to their diagnosis that are known to have a gene–drug interaction.
- The requested pharmacogenetic panel test has proven clinical validity as demonstrated through independent evaluation from a recognized third‑party source (including but not limited to MolDx, ECRI, Hayes, Optum Genomics, or FDA).
Panels without demonstrated clinical validity are not covered.
- The requested test is one of the following listed panels:
ANY of the following
- GeneSight (Assurex Health): 0345U
- Neuropharmagen (Precision Molecular Solutions): 81418
- PGXPSYCH (PHD Laboratory LLC): 81418
- Psychotropic Pharmacogenomics Gene Panel (Mayo): 81418
- Focused Pharm Panel (Mayo): 0029U
- IDgenetix (Castle): 0411U
- Tempus nP (Tempus): 0419U
- Mental Health Panel (Exceltox Laboratories LLC): 81418
- PGX (PHD Laboratory LLC): 81418
- PGS SHORT COMP (PHD Laboratory LLC): 81418
- Sinochips PGx Comprehensive (Sinochips Kansas LLC): 81418
- Carolina Comprehensive PGx (Carolina Diagnostics Lab): 81418
- COR120 - Comprehensive Pharmacogenetic Test (Quantigen LLC): 81418
- PCL PGX+ Comprehensive Report (Patients Choice Laboratories of Indiana, LLC): 81418
- PharmGx Comprehensive PGx Panel (Dxome CLIA Laboratory, Inc): 81418
- PsychPainMakers Panel (Genemarkers): 81418
- PredictScript Poly (Phenomics Health Inc): 81418
- PredictScriptCNS (Phenomics Health Inc): 81418
ALL of the following
- Covered clinical diagnoses for pharmacogenetic panel testing (panels listed above) must include ALL of the following:
Panels are limited to the indications below.
ANY of the following
- Major depressive disorder.
- Generalized anxiety disorder.
Coverage Criteria for Pharmacogenetic and Toxicology Genetic Testing
Policy updates and rationale summary for pharmacogenetic coverage criteria changes.
Coding and Billing References
Provider Actions, Authorization, and Documentation Requirements
Coding guidance and claims submission
This clinical policy references Current Procedural Terminology (CPT®). CPT is a registered trademark of the American Medical Association. CPT codes and descriptions are provided for informational purposes only and do not guarantee coverage. Providers should reference the most up-to-date professional coding guidance prior to submission of claims. The tests, CPT codes, and ICD codes referenced in this policy are not comprehensive. Please see the Concert Platform for additional registered tests.
- Providers must follow professional coding guidance when submitting claims.
- Codes shown in this policy are informational only; inclusion or exclusion does not guarantee coverage.
- See the Concert Platform for the list of registered tests and specific test coding.
Warfarin sensitivity multigene panel - authorization criteria
Multigene panel analysis for warfarin sensitivity requires prior authorization and is considered medically necessary only when the member/enrollee is being considered for or is undergoing treatment with warfarin AND the member has not reached a therapeutic dose. Additionally, clinical indications for coverage include prophylaxis and treatment of venous thrombosis or pulmonary embolism; prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement; or a history of previous myocardial infarction. Multigene panels used for this indication must demonstrate clinical validity for the genes included.
- Prior authorization required for warfarin sensitivity multigene panels when used for warfarin therapy guidance.
- Panels must be limited to relevant genes and demonstrate clinical validity via independent evaluation.
BCHE variant analysis - authorization criteria
BCHE variant analysis to determine drug metabolizer status is considered medically necessary when the member/enrollee is being considered for or is currently undergoing treatment with mivacurium (e.g., Mivacron) or succinylcholine (e.g., Anectine, Suxamethonium). BCHE testing for other indications is not supported by current evidence.
- Prior authorization may be required per plan rules when BCHE testing is ordered for mivacurium or succinylcholine exposure.
- Testing for BCHE for indications outside those listed is not supported and may be denied.
General denial/limited coverage for other single-gene PGx tests — not supported by current evidence
Current evidence does not support single-gene pharmacogenetic testing for many other genes (including, but not limited to, COMT, CYP1A2, KIF6, OPRM1, TYMS) to determine drug metabolizer status. Such tests are generally considered not medically necessary and may be denied or have limited coverage.
Prior authorization / criteria wording changes — 'being considered' or 'or is currently undergoing' language updates
Policy criteria language has been updated to clarify prior authorization and clinical-criteria statements. Wording such as "being considered for" or "is currently undergoing" treatment has been added across applicable criteria to better reflect clinical practice and authorization review. Providers should ensure documentation reflects whether a member is being considered for or is currently undergoing the relevant therapy when submitting authorization requests.
- Authorization requests must document whether the patient is being considered for or is currently undergoing the specified treatment.
- Plan-level prior authorization requirements remain in effect; follow payer-specific submission processes.
Use of Clinical Policy in Coverage Decisions — policy guidance does not guarantee payment and is plan-dependent
This clinical policy is guidance to assist in coverage determinations and does not guarantee payment. Coverage and payment decisions are subject to the member’s benefit plan, contract terms, and applicable state and federal requirements. Providers remain responsible for exercising professional judgment and for documenting medical necessity when submitting claims or prior authorization requests. When state Medicaid or Medicare requirements conflict with this policy, those requirements take precedence.
- Policy guidance does not guarantee payment — check the member’s benefit documents for coverage limits and exclusions.
- For Medicaid and Medicare members, applicable state and federal rules, NCDs, and LCDs take precedence over this policy.
Definitions and Terms Used in This Policy
Background, Clinical Guidance, and References
The policy references the FDA Table of Pharmacogenetic Associations as a key regulatory source that informs gene-drug management recommendations incorporated into coverage criteria. The FDA entries summarize clinically actionable gene-drug pairs and specify recommended management for affected subgroups — for example, the FDA recommends avoiding carbamazepine, and considering avoidance of fosphenytoin and phenytoin, in patients positive for HLA-B*15:02 due to increased risk of severe cutaneous reactions (SJS/TEN) [[54]].
Similarly, the FDA guidance for HLA-B*57:01 indicates that abacavir should not be used in allele-positive patients because of hypersensitivity risk [[55]]. For thiopurine-related genes TPMT and NUDT15, the FDA recommends dose reductions for intermediate metabolizers and consideration of alternatives or substantial dose adjustments for poor metabolizers to mitigate myelosuppression risk; specific dosing details are referenced to FDA labeling [[57]].
The FDA Table also provides gene-specific management for UGT family members and warfarin-related genes: for UGT1A1, poor metabolizers (e.g., *28/*28) may require reduced belinostat starting dose and modified irinotecan monitoring/dosing to reduce neutropenia risk [[59]]; for UGT2B17 (and CYP2C19 in the same entry) the FDA notes increased systemic concentrations with belzutifan in poor metabolizers and recommends monitoring for anemia and hypoxia [[60]].
For warfarin pharmacogenetics the FDA entry describes that variants in CYP2C9, CYP4F2, and VKORC1 can alter dosage requirements and that initial dosing should account for clinical and genetic factors with ongoing INR monitoring and dose adjustment — a rationale the policy uses to support single-gene and small targeted panel coverage for warfarin sensitivity when clinical criteria are met [[62]].
Policy updates revise coverage stance to align with current evidence and regulatory guidance. Pharmacogenetic panel testing, previously not medically necessary in the policy, was changed to a criteria-based approach consistent with LCD guidance for indications such as major depressive disorder and generalized anxiety disorder, with a minimum age requirement of 18 years and a requirement that the requested panel be a validated test demonstrating clinical validity via independent third-party evaluation (examples: MolDX, ECRI, Hayes, Optum Genomics, FDA) [[78],[79],[80]].
The revisions also add or clarify single-gene criteria and named tests: new criteria were created for HLA-A*02:01 (linked to therapies such as tebentafusp), and multiple single-gene entries (e.g., UGT1A1, UGT2B17, TPMT/NUDT15, VKORC1, CYP2C9) were updated to reflect FDA/NCCN recommendations and to include drug brand names or monitoring/dosing guidance where indicated [[78],[79],[80]].
Specifically, FDA management recommendations underpin several of the coverage changes: warfarin-related genes (CYP2C9, CYP4F2, VKORC1) are cited to justify allowing small targeted panels for warfarin sensitivity when members have not reached a therapeutic dose or meet other clinical triggers, with dosing and INR monitoring emphasized [[62]]. TPMT/NUDT15 guidance from the FDA supports dose-reduction or alternative therapy recommendations for intermediate/poor metabolizers, which the policy incorporates into TPMT/NUDT15 criteria [[57]]. UGT1A1 evidence from the FDA informed reduced starting dose and enhanced monitoring recommendations for irinotecan and belinostat that are reflected in the updated UGT1A1 criteria [[59]].
Overall, the material changes include addition of validated pharmacogenetic panels to the medically necessary list when criteria are met, expansion and clarification of single-gene indications tied to specific medications, and a requirement that panels demonstrate independent clinical validity — all intended to align coverage with available regulatory recommendations and clinical evidence while limiting unsupported single-gene analyses.
Policy Revision History and Material Changes
Semi-annual policy revision (03/23) — updated title to V1.2024, replaced 'coverage criteria' wording with 'criteria', added multiple single-gene tests (e.g., BCHE, CYP3A5, NAT2), and revised criteria language to 'being considered' or 'or is currently undergoing'.
Continued updates (10/23) — multiple single-gene and panel criteria edited, definitions updated, and additional clarifications to drug lists and indications were made.
Revision (11/23) — added CPT codes 0423U, 0434U, 0437U, 0438U to the policy coding reference table and updated pharmacogenetic panel criteria and assorted single-gene definitions and indications (e.g., UGT1A1, UGT2B17, VKORC1, DPYD, HLA variants).
Added new CPT/PLA codes 0423U, 0434U, 0437U, and 0438U to the policy coding reference table and incorporated them into panel test criteria references.
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