CurrentUnitedHealthcarePolicy CS150OH.F

Whole Exome and Whole Genome Sequencing (Non-Oncology Conditions) (for Ohio Only)

Governs medical necessity coverage for whole exome and whole genome sequencing for non-oncology conditions for UnitedHealthcare members in Ohio; references InterQual® molecular diagnostics criteria and Ohio Administrative Code for determinations.

Policy Summary

PayerUnitedHealthcare

PolicyWhole Exome and Whole Genome Sequencing (Non-Oncology Conditions) (for Ohio Only)

Policy CodePolicy CS150OH.F

Change TypeCode list update (added 0567U)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests that follow InterQual® CP: Molecular Diagnostics and member benefit plan rules for WES/WGS.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 0567U to the list of applicable codes.

~30+procedure codes listed (CPT/PLA)

Ohio onlygeographic applicability

InterQualclinical criteria source

CLIAlab regulation noted

Coverage Criteria

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Medically Necessary Criteria (delegated to InterQual®)

Covered when ALL of the following are met per InterQual® CP: Molecular Diagnostics

InterQual-based medical necessity: WES/WGS are considered proven and medically necessary in certain circumstances per InterQual® CP: Molecular Diagnostics; clinical determination and specific eligibility are governed by the InterQual® criteria.refer to InterQual®

Policy defers to InterQual® for the explicit clinical criteria and decision pathway

The presence of a procedure or diagnosis code in this policy is for reference only and does not by itself indicate that the service described by the code is covered. Benefit coverage is determined by the member-specific benefit plan document and applicable laws, and inclusion of a code does not guarantee reimbursement or claim payment.

This policy applies only to the state of Ohio. Requests for services described as unproven or subject to coverage/quantity limits will be evaluated for medical necessity under Ohio Administrative Code 5160-101, and may be determined not medically necessary if the OAC criteria are not met.

Covered Indications

Hereditary hearing loss — InterQual® criteria apply

InterQual® CP: Molecular Diagnostics criteria apply for this indication.

Hereditary hearing loss indication: Testing is considered under InterQual® criteria for hereditary hearing loss; follow InterQual® CP for specific clinical inclusion/exclusion and required documentation.refer to InterQual®

UnitedHealthcare uses InterQual® as the primary clinical criteria source; also follow applicable federal/state/contractual rules.

Congenital or hereditary disorders — WGS, WES, and CMA referenced; InterQual® criteria apply

InterQual® CP: Molecular Diagnostics criteria apply for congenital or hereditary disorders; testing types referenced include WGS, WES, and CMA.

Congenital or hereditary disorders indication: Whole genome sequencing (WGS), whole exome sequencing (WES), and chromosomal microarray (CMA) are addressed under InterQual® criteria for evaluation of congenital or hereditary disorders; follow InterQual® for clinical eligibility, comparator testing, and prior testing requirements.refer to InterQual®

Policy defers to InterQual® for specific pathways (e.g., when CMA or targeted testing is required before WES/WGS) and to applicable federal/state/contractual requirements.

Coding (PLA / CPT / Comparator Codes)

Applicable PLA/CPT Category III Examplemixed

0094U

Genome (e.g., unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis

Applicable PLA Codes (portion)mixed

0212U	Rare diseases (constitutional/heritable disorders), whole genome and mitochondrial DNA sequence analysis, including small sequence changes, deletions, duplications, short tandem repeat gene expansions, and variants in non-uniquely mappable regions, blood or saliva, identification and categorization of genetic variants, proband.
0213U	Rare diseases (constitutional/heritable disorders), whole genome and mitochondrial DNA sequence analysis, including small sequence changes, deletions, duplications, short tandem repeat gene expansions, and variants in non-uniquely mappable regions, blood or saliva, identification and categorization of genetic variants, each comparator genome (e.g., parent, sibling).
0214U	Rare diseases (constitutional/heritable disorders), whole exome and mitochondrial DNA sequence analysis, including small sequence changes, deletions, duplications, short tandem repeat gene expansions, and variants in non-uniquely mappable regions, blood or saliva, identification and categorization of genetic variants, proband.
0215U	Rare diseases (constitutional/heritable disorders), whole exome and mitochondrial DNA sequence analysis, including small sequence changes, deletions, duplications, short tandem repeat gene expansions, and variants in non-uniquely mappable regions, blood or saliva, identification and categorization of genetic variants, each comparator exome (e.g., parent, sibling).
0265U	Rare constitutional and other heritable disorders, whole genome and mitochondrial DNA sequence analysis, blood, frozen and formalin-fixed paraffin-embedded (FFPE) tissue, saliva, buccal swabs or cell lines, identification of single nucleotide and copy number variants.
0335U	Rare diseases (constitutional/heritable disorders), whole genome sequence analysis, including

Applicable PLA Codes (continued)mixed

0336U	Rare diseases (constitutional/heritable disorders), whole genome sequence analysis, including small sequence changes, copy number variants, deletions, duplications, mobile element insertions, uniparental disomy (UPD), inversions, aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, short tandem repeat (STR) gene expansions, blood or saliva, identification and categorization of genetic variants, each comparator genome (e.g., parent).
0425U	Genome (e.g., unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis, each comparator genome (e.g., parents, siblings).
0426U	Genome (e.g., unexplained constitutional or heritable disorder or syndrome), ultra-rapid sequence analysis.
0454U	Rare diseases (constitutional/heritable disorders), identification of copy number variations, inversions, insertions, translocations, and other structural variants by optical genome mapping.
0469U	Rare diseases (constitutional/heritable disorders), whole genome sequence analysis for chromosomal abnormalities, copy number variants, duplications/deletions, inversions, unbalanced translocations, regions of homozygosity (ROH), inheritance pattern that indicate uniparental disomy (UPD), and aneuploidy, fetal sample (amniotic fluid, chorionic villus sample, or products of conception), identification and categorization of genetic variants, diagnostic report of fetal results

Applicable Codes (WGS/WES examples)CPT | PLA

0532U	Rare diseases (constitutional disease/hereditary disorders), rapid whole genome and mitochondrial DNA sequencing for single-nucleotide variants, insertions/deletions, copy number variations, peripheral blood, buffy coat, saliva, buccal or tissue sample, results reported as positive or negative.
0567U	Rare diseases (constitutional/heritable disorders), whole-genome sequence analysis combination of short and long reads, for single-nucleotide variants, insertions/deletions and characterized intronic variants, copy-number variants, duplications/deletions, mobile element insertions, runs of homozygosity, aneuploidy, and inversions, mitochondrial DNA sequence and deletions, short tandem repeat genes, methylation status of selected regions, blood, saliva, amniocentesis, chorionic villus sample or tissue, identification and categorization of genetic variants.
81415	Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis

Applicable CPT Codes (Exome/Genome)CPT

81416	Exome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator exome (e.g., parents, siblings) (List separately in addition to code for primary procedure).
81417	Exome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained exome sequence (e.g., updated knowledge or unrelated condition/syndrome).
81425	Genome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis.
81426	Genome (e.g., unexplained constitutional or heritable disorder or syndrome); sequence analysis, each comparator genome (e.g., parents, siblings) (List separately in addition to code for primary procedure).
81427	Genome (e.g., unexplained constitutional or heritable disorder or syndrome); re-evaluation of previously obtained genome sequence (e.g., updated knowledge or unrelated condition/syndrome).

Comparator exome/genome billing

Comparator billing instructionReport each comparator exome/genome using the designated comparator code (examples: 0213U, 0215U, 81416, 81426).

PLA comparator examples0213U (each comparator genome); 0215U (each comparator exome).

CPT comparator examples81416 (each comparator exome); 81426 (each comparator genome).

Use case guidanceWhen parental or sibling comparator sequencing is performed, bill the appropriate comparator code for each comparator sample submitted.

Reference in code listComparator codes are listed alongside proband codes in the policy's Applicable Codes section.

Provider Actions & Operational Guidance

Prior Authorization

Prior authorization per InterQual® and plan rules

Coverage determinations for WES/WGS are made using InterQual® CP: Molecular Diagnostics and must also be consistent with the member's benefit plan and applicable Ohio requirements; prior authorization may be required per plan rules.

Follow InterQual® CP: Molecular Diagnostics for medical necessity decisions.
Ensure decisions align with member-specific benefit plan rules and Ohio requirements; obtain prior authorization if the plan requires it.

Step Therapy

Step therapy

This policy does not state any step therapy requirements for WES/WGS.

Documentation Required

Document reference to OAC and InterQual®

When deciding coverage, reference federal, state (Ohio Administrative Code) or contractual benefit requirements and document how the decision conforms to those rules and to InterQual® criteria.

Document medical necessity consistent with InterQual® CP: Molecular Diagnostics and any applicable federal/state/contractual provisions.

Denial Risk

Coverage not guaranteed by code listing

Listing of a procedure code in this policy is for reference only and does not imply the service is covered or not covered; benefit coverage is determined by the member-specific benefit plan and applicable laws.

Inclusion of a code does not guarantee reimbursement or claim payment.

Denial Risk

OAC medical necessity evaluation may trigger denial

Requests for services described as unproven or subject to coverage/quantity limits will be evaluated for medical necessity using Ohio Administrative Code 5160-101 and may be denied if OAC criteria are not met.

Note

Genetic counseling requirements

The policy does not impose explicit pre- or post-test genetic counseling requirements; follow InterQual®, the member's plan requirements, or local clinical practice standards as applicable.

Note

Ordering provider eligibility

The policy does not specify which provider types may order WES/WGS; providers must follow InterQual®, member plan rules, and any applicable state or contractual requirements when ordering tests.

OpenPayer

Whole Exome and Whole Genome Sequencing (Non-Oncology Conditions) (for Ohio Only)

Coverage Criteria

Covered Indications

Coding (PLA / CPT / Comparator Codes)

Eligibility Requirements

Provider Actions & Operational Guidance

Definitions & Regulatory References

Background

Not Covered / Exclusions