CurrentArizona Complete HealthPolicy N/A

Concert Genetic Testing: Identity and Forensics

Defines coverage stance for genetic tests performed to confirm the identity/provenance of laboratory specimens (e.g., DSPA assays) for members of health plans affiliated with Centene Corporation; affects ordering providers, laboratories, and billing for such tests.

Policy Summary

PayerArizona Complete Health

PolicyConcert Genetic Testing: Identity and Forensics

Policy CodePolicy N/A

Change TypeRevised (coverage language clarified)

Effective DateN/A

Next Review DateN/A

Key ActionDo not bill separately for genetic testing performed solely to confirm laboratory specimen identity; document indication and rationale if performed.

SourceLink

POLICY UPDATE CHANGES

The statement was changed from labeling the test as 'investigational' to stating that 'current evidence does not support' performing separate genetic testing to confirm specimen identity.

1primary coverage statement for specimen identity testing

81265,81266,81479example CPT/test codes referenced

noneNCCN guidance on separate identity testing

1external references cited

Coverage Criteria — Specimen Identity Genetic Testing

Genetic Testing to Confirm the Identity of Laboratory Specimens

Not covered (or not supported) statement

Primary coverage statement: Current evidence does not support genetic testing to confirm the identity of laboratory specimens (e.g., know error) when billed separately for all indications because it is generally considered to be an existing component of the genetic testing process for quality assurance.

This replaces prior language that labeled such testing as 'investigational.'

Separate billing for genetic testing performed solely to confirm the identity of laboratory specimens is not supported. Current evidence does not support genetic testing to confirm specimen identity when billed separately for all indications, because such testing is generally considered part of the laboratory quality assurance process and the genetic testing workflow rather than a standalone, billable service.

Genetic testing conducted exclusively to verify specimen identity and billed as a separate claim is not supported by available evidence and therefore is not considered a medically necessary, standalone service. Providers should not expect separate reimbursement when the testing is performed only to confirm specimen provenance, as this activity is typically encompassed within standard laboratory quality assurance procedures.

Policy Summary

PayerArizona Complete Health

PolicyConcert Genetic Testing: Identity and Forensics

Policy CodePolicy N/A

Change TypeRevised (coverage language clarified)

Effective DateN/A

Next Review DateN/A

Key ActionDo not bill separately for genetic testing performed solely to confirm laboratory specimen identity; document indication and rationale if performed.

SourceLink

On This Page

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.

None specified — policy states current evidence does not support separate identity testing for any indication.

Covered indications — none specified

Covered indications: None specified — current evidence does not support performing separate genetic testing to confirm specimen identity for any indication.

Policy explicitly states that separate specimen identity testing billed alone is not supported.

Example CPT / ICD-10 Codes

Example referenced CPT / test codesCPT

81265	as referenced in policy
81266	as referenced in policy
81479	as referenced in policy

Example referenced ICD-10 codesICD-10

C00.0-D49

range of diagnosis codes referenced in policy

Provider Actions, Billing and Documentation

Prior Authorization

Prior Authorization / Coding Note

Prior authorization and coding: The CPT, HCPCS, and ICD codes referenced in this policy are provided for informational purposes only and do not guarantee coverage. Providers should verify current coding guidance and payer requirements prior to submitting claims. Separate billing for genetic testing performed solely to confirm the identity/provenance of laboratory specimens (e.g., "know error" or DNA specimen provenance assays) is not supported when billed alone.

Affected codes are informational only — verify up-to-date CPT/ICD guidance before claim submission.
Separate billing for specimen identity testing (including assays such as DSPA) is not supported.

Billing Rule

Separate Specimen Identity Testing Billed Alone

Billing rule: Genetic testing to confirm laboratory specimen identity is considered part of the laboratory's internal quality assurance processes and is not covered when billed as a separate genetic test service.

Do not bill CPT codes separately for specimen identity confirmation when no additional clinically indicated genetic testing is performed.
If specimen identity confirmation is performed solely for chain-of-custody or internal QA, include as part of the primary laboratory service rather than a stand‑alone genetic test claim.

Documentation Required

Documentation and Coding Guidance

Documentation: Providers must document the clinical indication, rationale for testing, and how results will impact patient management in the medical record. CPT and ICD codes listed in this policy are informational and should be supported by appropriate clinical documentation.

Include clinical indication and how test results will change management in the chart note.
Attach laboratory reports and chain-of-custody or specimen handling documentation when relevant to support medical necessity.
Use ICD-10 diagnosis codes that reflect the clinical reason for testing; CPT codes in this policy are informational only.

Denial Risk

Provider-Impact Reminder

Provider-impact highlight: Actions to avoid denials — do not submit separate claims for genetic testing performed solely to confirm specimen identity. Ensure testing billed as a genetic test has a documented clinical indication and is not solely a quality assurance or provenance assay.

If the only purpose of testing is specimen verification (e.g., Know Error/DSPA), do not bill as a separate genetic test.
When clinical diagnostic genetic testing is performed in addition to specimen verification, document both indications and bill only for the clinically indicated test(s).

Not Covered — Specimen Identity Testing Billed Separately

Not covered: Genetic testing to confirm specimen identity that is billed separately is not supported and is therefore not covered. Tests intended solely for specimen provenance confirmation (for example, Know Error DNA Specimen Provenance Assay) performed and billed as standalone services do not meet the policy's coverage criteria.

Definitions

DSPA / specimen provenance assay — definition

TermKnow Error DNA Specimen Provenance Assay (DSPA)

Manufacturer / ExampleStrand Diagnostics, LLC

Test purposeSpecimen provenance assay to confirm the identity of laboratory specimens (specimen identity testing)

Policy stanceReferenced as an example of specimen identity testing; separate billing for these tests is not supported by current evidence

Associated codesExample CPT/test codes referenced in policy: 81265, 81266, 81479; ICD-10 range: C00.0–D49

Background

This policy addresses genetic tests used to confirm the identity (provenance) of laboratory specimens. The policy clarifies that current evidence does not support performing genetic testing to confirm specimen identity as a separately billed service, since such testing is generally considered part of the genetic testing process for quality assurance rather than a distinct, billable procedure.