ModifiedUnitedHealthcarePolicy DCP036.10

Genetic Testing for Oral Disease

Defines UnitedHealthcare's coverage stance for genetic tests and specimen collection related to oral diseases (including oral HPV and tests for susceptibility to periodontal disease and caries) for dental/oral & maxillofacial care.

Policy Summary

PayerUnitedHealthcare

PolicyGenetic Testing for Oral Disease

Policy CodePolicy DCP036.10

Change TypeClarified referencesarchived prior version

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionVerify member-specific benefits and prior authorization requirements before ordering genetic tests.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information.

2procedure codes referenced

limitedevidence base

endorsed tests notedguideline guidance

NCapplicable state

07/01/2025policy revision date

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Not indicated / Not supported

Services described below are not indicated due to insufficient evidence of efficacy:

Nonindicated services: Collection, preparation, and testing of genetic sample material, including oral Human Papillomavirus (HPV), is not indicated due to insufficient evidence of efficacy.

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Genetic susceptibility testing: Genetic testing for susceptibility to oral disease, including oral HPV–related cancer, is not indicated due to insufficient evidence of efficacy.

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The policy identifies specific services that are not indicated because the available evidence does not demonstrate clinical efficacy. In particular, the collection and preparation of genetic sample material for laboratory analysis — including samples intended for oral Human Papillomavirus (HPV) testing — is considered not indicated due to insufficient evidence of efficacy.

Additionally, genetic testing intended to assess susceptibility to oral diseases (for example, tests claiming to predict risk of periodontal disease or dental caries based on genetic markers) is not indicated because clinical utility has not been established.

FDA regulatory status information is provided for context only: FDA approval alone is not a basis for coverage. The policy notes example products used for genetic testing related to oral disease (for informational purposes) and reminds readers that laboratories performing these tests are regulated under CLIA.

UnitedHealthcare does not cover genetic tests or related specimen collection for oral disease because the evidence does not support their clinical utility. Specifically, genetic tests and specimen collection for oral disease — including oral HPV testing and genetic susceptibility assays — are considered not medically necessary / not indicated and are therefore not covered under this policy.

Provider Actions and Billing Guidance

Denial Risk

Services Not Indicated / Denial Risk

Claims for D0422 and D0423 are not indicated by this policy and may be denied. Providers should ensure documentation supports medical necessity before submitting claims.

D0422 — Collection and preparation of genetic sample material for laboratory analysis and report
D0423 — Genetic test for susceptibility to diseases - specimen analysis

Note

Coverage Determinations Must Reference Member Benefit Plan

When deciding coverage, the member specific benefit plan document must be referenced. The member specific plan governs when there is any conflict with this policy. Check for applicable federal or state mandates that may affect coverage.

Reference the member specific benefit plan document before ordering or billing
In the event of a conflict, the member specific benefit plan governs

Prior Authorization

Verify Member Benefits and Prior Authorization

Verify member benefits and prior authorization requirements before ordering genetic testing or related specimen collection. Coverage varies by plan and prior authorization may be required.

Confirm member eligibility and benefits for genetic testing
Obtain prior authorization when required by the member specific plan

Billing Rule

Coding and Billing Note

Include applicable procedure codes on claims for reference; listing of a code does not imply coverage. Providers must submit the correct CPT/HCPCS/diagnosis codes and supporting documentation to substantiate medical necessity.

Include procedure codes (e.g., D0422, D0423) on claims as applicable
Code inclusion in this policy is for reference only and does not guarantee payment

Documentation Required

Benefit Plan Reference and Escalation

Check the member specific benefit plan for any federal/state mandated coverage differences and escalate coverage determination questions to the member specific plan when conflicts arise.

Review federal/state mandates that may impact coverage
Escalate discrepancies between this policy and the member specific plan to plan administration

Step Therapy

Step Therapy / Care Sequencing

No step therapy or sequencing requirements are specified for genetic tests in this policy. Preventive visit guidance: two annual preventive visits are supported for dental care irrespective of genetic testing.

No step therapy requirements for genetic tests in this policy
Evidence supports two annual preventive dental visits for all patients

Background

Periodontal disease and dental caries are multifactorial conditions influenced by behavior, environment, and host factors including genetics. Although genetic and salivary assays have been proposed to stratify risk, the literature described in this policy emphasizes heterogeneous, small studies and lacks consistent evidence that these tests change clinical management or improve outcomes.

Chronic infection with high-risk HPV genotypes (for example, HPV16 and HPV18) is associated with oropharyngeal cancers, but routine oral HPV genetic testing has not been shown to alter patient management in a way that provides net benefit. Professional guidance and available reviews do not support predictive genetic testing for caries or periodontal disease as having established clinical utility.

Definitions

High-risk HPV (HR-HPV) — genotypes like HPV16/18 as risk factors for oropharyngeal cancers

DefinitionHigh-risk HPV (HR-HPV) refers to HPV genotypes that are independent risk factors for oropharyngeal cancer; examples include HPV16 and HPV18.

Clinical contextChronic infection with high-risk HPV can cause cancer in parts of the body where HPV infects cells, including the oropharynx; oropharyngeal cancer is the most common cancer caused by HPV in the U.S.

LimitationsIt is unclear if HPV infection alone is sufficient to cause oropharyngeal cancers; other factors (e.g., smoking, chewing tobacco) may interact with HPV to influence cancer risk.

Predictive genetic tests for caries/periodontal disease — tests intended to predict individual risk based on polymorphisms

DefinitionPredictive genetic tests for caries or periodontal disease are tests intended to predict individual risk based on genetic polymorphisms.

Current statusPredictive tests for dental caries or for periodontal disease do not currently exist with established clinical utility.

RationalePeriodontal disease and caries are multifactorial with multiple gene and environmental risk factors; environmental influences (e.g., smoking, diabetes) have larger impacts than any single gene identified to date.

CLIA regulation — labs performing genetic tests regulated under CLIA

Regulatory authorityLaboratories that perform genetic tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA) Act of 1988.

ResourceMore information on CLIA is available at https://www.cms.gov/clia/ (Accessed April 28, 2025).

ImplicationCLIA regulation applies to laboratories performing genetic testing and governs laboratory quality standards rather than coverage decisions.

FDA informational status — note that FDA approval alone is not a basis for coverage; info on LDTs available from FDA

Coverage noteFDA approval alone is not a basis for coverage of genetic testing products for oral disease.

Examples of productsProducts for genetic testing for oral disease include MyPerioID (OralDNA Labs), OraRisk HPV, and Complete genotyping (OralDNA Labs).

LDT informationInformation regarding regulation of Laboratory Developed Tests (LDTs) is available from the FDA: https://www.fda.gov/.../LaboratoryDevelopedTests/ (Accessed April 28, 2025).

OpenPayer

Genetic Testing for Oral Disease

Coverage Criteria

Coding

Provider Actions and Billing Guidance

Background

Definitions

D0422	Collection and preparation of genetic sample material for laboratory analysis and report.
D0423	Genetic test for susceptibility to diseases - specimen analysis