Codes explicitly listed as not covered

Use the following CPT and HCPCS codes exactly as listed when submitting claims: 0100T, 0472T, 0473T, 0616T, 0617T, 0618T, C1839, C1841, C1842, L8608. These codes are identified in the policy as not covered for the indications in this Clinical Policy Bulletin and should not be billed for covered indications under this CPB.

• CPT: 0100T, 0472T, 0473T, 0616T, 0617T, 0618T
• HCPCS: C1839, C1841, C1842, L8608

Prior authorization: document candidacy, rehab, counseling, team assessment

Obtain pre-authorization when requesting coverage or exception review, and include documentation that the patient meets candidacy criteria, has completed or been assessed for prior rehabilitation, received expectations counseling, and underwent multidisciplinary evaluation. The policy recommends these elements to support any coverage exception requests for specialized device procedures.

• Document candidacy criteria and prior rehabilitation
• Include expectations counseling and multidisciplinary team assessment

Prior authorization: indicate FDA‑approved CustomFlex device

When seeking approval for an FDA‑approved CustomFlex Artificial Iris, note device regulatory status and supply documentation that the CustomFlex device is the implanted prosthesis versus non‑marketed or cosmetic implants. The policy distinguishes FDA‑approved CustomFlex from investigational devices and advises noting FDA-approved device use in authorization requests.

• Indicate that CustomFlex Artificial Iris (FDA‑approved) is used
• Differentiate FDA‑approved device from investigational or cosmetic implants

Prior authorization: no PA requirement specified in this extract

No specific routine prior authorization form or requirement is listed in this extract; providers should follow standard plan processes but recognize the policy does not specify an automatic PA pathway in these sections.

Selection: confirm indication and assess alternatives before implantation

Confirm that the patient has end‑stage outer retinal disease (e.g., retinitis pigmentosa) for retinal prosthesis candidates or a clinically significant iris defect (congenital, traumatic, iatrogenic) for artificial iris candidates, and assess alternative, less-invasive options prior to implant consideration.

• For Argus II candidates: confirm end‑stage outer retinal disease and profound vision loss
• For artificial iris candidates: document indication (congenital, traumatic, iatrogenic) and remnant iris status

Conservative alternatives: document failure/intolerance of non‑surgical options

Before implantation, document trial and failure or intolerance of conservative alternatives when appropriate — for example, colored contact lenses, corneal tattooing, or prosthetic contact options — and record why these measures are unsuitable or unsuccessful for the patient.

• Document use and failure/intolerance of colored contact lenses
• Document consideration and unsuitability of corneal tattooing or prosthetic contact options

Supporting documentation: supply clinical trial reports and outcome data

Provide supporting clinical trial reports and outcome data when requesting coverage exceptions; the policy background documents trial enrollment, visual function tests, and adverse events that support evaluation of medical necessity.

• Include relevant clinical trial reports and objective visual function test results (mobility, localization, grating VA, Goldmann field)
• Report trial enrollment and follow‑up duration as applicable

Required clinical documentation: device, laterality, complications, objective outcomes

Include detailed clinical documentation with any request: identify the device implanted, laterality, perioperative and long‑term complications, objective visual function test results (e.g., mobility, localization, grating visual acuity, Goldmann field), and follow‑up duration to support assessment of outcomes and necessity.

• Device model and laterality
• Perioperative and long‑term complications and interventions
• Objective visual function test results and follow‑up duration

Required clinical documentation: indications, ocular history, surgical technique, follow‑up

Document specific clinical indications and prior ocular history in the medical record, including congenital or traumatic aniridia, iris melanotic lesion excision, Urrets‑Zavalia syndrome, aphakia, and relevant comorbidities; also detail surgical technique (endocapsular, sulcus, scleral fixation) and follow‑up findings (BCVA, IOP, complications, patient satisfaction).

• Indication (congenital, traumatic, iatrogenic) and prior ocular comorbidities
• Surgical technique and post‑operative findings including BCVA and IOP

Policy history and notices: extract includes review history but not additional documentation lists

This policy extract includes policy history and boilerplate notices; it does not substitute for submitting required clinical documentation with any authorization or exception request — providers should still follow the documentation guidance in the policy when requesting coverage.

Denial risk: experimental and investigational interventions may be denied

Interventions classified as experimental and investigational (artificial retina devices such as Argus II and artificial iris devices such as CustomFlex for the listed indications) are not considered established; services for these interventions may be denied as not medically necessary.

Adverse event reporting: fully document serious device‑ or surgery‑related AEs

Report and document serious device‑ or surgery‑related adverse events thoroughly; the Argus II trial reported 11 subjects with 23 serious device‑ or surgery‑related adverse events, and inadequate AE reporting or lacking complication details could jeopardize claims or exception requests.

• Include full details of any serious adverse events and their management
• Attach treatment records showing resolution or ongoing care for AEs

Complication‑related utilization risk: prior cosmetic implant complications often require explantation and further surgery

Recognize heightened utilization and reoperation risk after complications from cosmetic artificial iris implants; the policy documents frequent serious complications (elevated IOP, corneal edema, inflammation) that often required explantation and additional surgeries and may trigger high‑level review for subsequent utilization.

• Document any prior cosmetic iris implantation and subsequent complications or explantation
• Expect potential denial or additional review for procedures related to prior device complications

Not applicable / cosmetic implants: elective cosmetic iris implants associated with high complication and explantation rates

Document that conservative, non‑marketed cosmetic iris implants are associated with high complication and explantation rates; the policy highlights that elective cosmetic iris implants lack supportive safety evidence and often required removal and further interventions.