CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Specimen Provenance (Know Error) DNA Identity Testing

Policy governs coverage for the Know Error specimen provenance DNA test used to verify specimen identity in biopsy/pathology workflows; applies to Medicare Advantage and Commercial products under Blue Cross & Blue Shield of Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicySpecimen Provenance (Know Error) DNA Identity Testing

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 21, 2011

Next Review DateN/A

Key ActionDo not bill or expect coverage for Know Error specimen provenance DNA testing; the test is considered hospital quality control and provider liability.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredcoverage stance

84999reporting code

Hospital QCpolicy rationale

MA & Commercialapplicable products

Coverage Criteria

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Covered Indications

Covered when ALL of the following are met:

Intended use: Test is intended to verify specimen identity by comparing surgical/biopsy tissue to a pre-procedure reference DNA sample collected and sent to an independent forensic laboratory.

Workflow includes a kit with bar-coded specimen containers sent to the surgeon and returned to pathology for evaluation.

Policy conclusion: Despite the intended use to verify specimen identity and prevent specimen misidentification in biopsy workflows, the Know Error test is not covered and is considered provider liability as part of hospital quality control.

Applies to Medicare Advantage and Commercial products per policy.

Provider Actions and Billing Guidance

Prior Authorization

Prior authorization

Not applicable — no prior authorization is required for laboratory or specimen handling procedures related to this policy.

Note

Provider action

Providers should ensure routine administrative steps are followed (scheduling, consent, and standard specimen labeling) for biopsies and related laboratory testing.

Documentation Required

Test workflow documentation

Prior to the procedure, a reference DNA sample must be collected from the patient and sent to an independent forensic laboratory. A kit with bar‑coded specimen containers should be provided to the surgeon; the surgeon places the biopsy specimen into the provided containers and returns them to the pathology lab for evaluation. If a test report indicates a potential mismatch, the forensic lab will compare the tissue specimen to the previously collected reference sample to confirm identity.

Collect and send reference DNA sample to an independent forensic lab before the procedure.
Use the supplied bar‑coded kit for specimen collection and chain-of-custody.
Return specimen to pathology lab for routine evaluation; forward results to forensic lab for identity confirmation if indicated.

Denial Risk

Coverage and denial risk

Use of the Know Error system is considered part of hospital quality control for specimens and is not covered. Claims for Know Error testing will be denied and are the financial responsibility of the provider.

Know Error testing is not covered — submitters should expect claim denial.
Providers retain liability for costs associated with Know Error testing when performed.
Do not bill Blue Cross Blue Shield of Rhode Island for Know Error specimen identity testing.

Ordering Requirements

Step Therapy

Ordering workflow — reference sample, bar-coded kit, and independent lab

Order workflows should include collection of a pre-procedure reference DNA sample, placement of specimens in the kit's bar‑coded containers, and sending the reference sample to an independent forensic laboratory; the policy does not impose ordering or provider-type restrictions.

Collect and document a pre-procedure reference DNA sample.
Use the kit with bar-coded specimen containers to return specimens to pathology.
Send the reference sample to an independent forensic lab for comparison.
No specific ordering/provider-type requirements are specified by the policy.

Background

The Know Error system is a DNA-based specimen identity verification tool that compares a surgical or biopsy specimen to a pre-procedure reference DNA sample. Workflow elements include collection of a reference sample prior to the procedure, use of a kit with bar‑coded specimen containers sent to the surgeon, return of specimens to pathology, and confirmation by an independent forensic laboratory when a positive match requires definitive identity verification.

Definitions

Specimen provenance testing definition (Know Error)

Test nameKnow Error (specimen provenance DNA test)

PurposeVerify that surgical/biopsy specimens correspond to the correct patient by comparing tissue to a pre-procedure reference DNA sample.

WorkflowA pre-procedure reference DNA sample is collected and sent to an independent forensic laboratory; a kit with bar-coded specimen containers is used to collect and return surgical/biopsy specimens for comparison.

Intended benefitReduce specimen misidentification and specimen provenance complications in biopsy evaluation workflows.

Role in careQuality-control/identity verification procedure rather than a diagnostic test for disease—used to confirm specimen-patient match.