Prior Authorization Required for IRD Multigene Panels

Prior authorization is required for inherited retinal dystrophies (IRD) multigene panel testing. Submit a prior authorization request before testing to avoid claim denials or delays.

• Affected CPT codes: 81404, 81406 (removed from some references—see coding change), 81408, 81434, 81479
• Minimum gene requirement for IRD panels: RPE65 must be included

Prior Authorization and Coverage Caveat

Prior authorization is required and coverage is limited to specific clinical indications. Testing for IRD multigene panels is considered medically necessary only when the member has clinical findings consistent with rod-cone degeneration, cone-rod degeneration, chorioretinal degeneration, or macular dystrophy, and when the panel includes the RPE65 gene. Genetic testing for macular degeneration is not supported by current evidence and is likely to be denied.

• Medical necessity indications for IRD multigene panels: see clinical criteria (rod-cone degeneration, cone-rod degeneration, chorioretinal degeneration, macular dystrophy)
• Macular degeneration testing codes called out: 81404, 81408, 81479, 81599, 0205U — testing for age-related macular degeneration is not supported

Coding Change May Affect Claims

A coding update may affect claims processing. CPT code 81406 was removed from certain test references and criteria; verify the codes submitted on claims match the current payer coding guidance and the test performed.

• Removed from policy reference table and criteria: CPT 81406 (effective update noted in revision history)
• Confirm submitted CPT codes align with the laboratory invoice and current policy

Required Clinical & Genetic Documentation

Required clinical and genetic documentation must be provided with the prior authorization and retained for claims: clinical findings consistent with the covered eye disorder, documentation that RPE65 is included on the panel, and genetic test reports showing variant classification and zygosity/phase when applicable.

• Clinical documentation: signs/symptoms and findings that meet the IRD criteria (e.g., findings consistent with retinitis pigmentosa, achromatopsia, chorioretinal degeneration, or macular dystrophy)
• Genetic documentation: laboratory report with gene list demonstrating RPE65 included, variant classifications (pathogenic/likely pathogenic), and evidence of trans configuration when two RPE65 variants are present
• Counseling documentation: note that patient received genetic counseling or referral to a genetics expert

Clinical Features Documentation for Other Covered Eye Disorders

When requesting coverage for other covered eye disorders, include clinical features that align with the disorder per established resources (GeneReviews, OMIM, Genetics Home Reference, etc.). Approval may be appropriate for rare conditions when clinical features support testing.

• Examples of disorders with known genetic association: Duane Syndrome; Familial Exudative Vitreoretinopathy; Aniridia; X-linked Congenital Retinoschisis; Presenile Cataracts
• Clinical features should be documented in the record and cited from authoritative resources when possible

Documentation and Coverage Alignment Reminder

Ensure documentation submitted with prior authorization and claims aligns with policy coverage criteria. Lack of required clinical or genetic documentation may result in denial. Keep copies of genetic counseling notes and laboratory reports in the medical record.

• Denial risk is elevated when clinical findings in the record do not meet the policy's IRD criteria
• If two RPE65 variants are reported, documentation of trans configuration (phase) is required to establish biallelic disease

Step Therapy Not Applicable

No explicit step therapy requirements apply to the genetic tests discussed in this policy. Step therapy is not specified for these genetic tests within this document.