Aetna modified CPB 0713, classifying both artificial retina and artificial iris devices as experimental and investigational, effective November 27, 2025. CPT codes 0100T, 0472T, 0473T, 0616T, 0617T, 0618T, and 66683—along with HCPCS codes C1839, C1841, C1842, and L8608—are all non-covered under this policy. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its artificial retina and artificial iris coverage policy under CPB 0713. The policy draws a hard line: no covered indications exist for these devices. That means any claim you submit using these codes against an Aetna plan will deny—regardless of the diagnosis code attached.
If your ophthalmology or anterior segment reconstruction practice bills Aetna, this update deserves immediate attention. The affected patient populations include aniridia, traumatic iris defects, aphakia, retinitis pigmentosa, and diabetic retinopathy—all conditions where surgeons sometimes reach for these devices.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Artificial Retina and Artificial Iris |
| Policy Code | CPB 0713 |
| Change Type | Modified |
| Effective Date | November 27, 2025 |
| Impact Level | High |
| Specialties Affected | Ophthalmology, Retinal Surgery, Anterior Segment Surgery, Ocular Oncology |
| Key Action | Flag all CPT codes 0100T, 0472T, 0473T, 0616T–0618T, and 66683 as non-covered for Aetna patients and update charge capture before November 27, 2025 |
Aetna Artificial Retina and Artificial Iris Coverage Criteria and Medical Necessity Requirements 2025
The short answer on Aetna artificial retina and artificial iris coverage policy is this: there are no covered indications. Aetna does not consider these devices medically necessary under any diagnosis. The policy doesn't offer a pathway to coverage even with prior authorization, because the payer's position is that clinical evidence hasn't established effectiveness.
This is a significant stance. The Argus II retinal prosthesis—the device explicitly named in the policy—received FDA approval over a decade ago. The CustomFlex Artificial Iris received FDA clearance in 2018. Yet Aetna's medical necessity standard requires established clinical effectiveness, and the payer has concluded neither device meets that bar.
The practical consequence is zero reimbursement. There's no appeals pathway built on medical necessity arguments when the payer has categorically classified the intervention as experimental. If your practice has been submitting these claims and occasionally winning on appeal, this policy update tightens that door considerably.
Don't expect prior authorization to unlock coverage here. When a payer classifies something as experimental and investigational, prior auth requests typically come back as non-covered—not just as denied but as categorically excluded. That distinction matters for how you counsel patients before surgery.
Aetna Artificial Retina and Artificial Iris Exclusions and Non-Covered Indications
Aetna's CPB 0713 positions both device categories under a single experimental, investigational, or unproven classification. The policy names specific devices to remove any ambiguity.
Artificial retina devices — The Argus II is explicitly cited. This covers CPT 0100T (placement of subconjunctival retinal prosthesis receiver and pulse generator), CPT 0472T (device evaluation, interrogation, and initial programming of intra-ocular retinal electrode array), and CPT 0473T (device evaluation and interrogation of intra-ocular retinal electrode array). HCPCS C1841 (retinal prosthesis, all internal and external components), C1842 (retinal prosthesis add-on), and L8608 (miscellaneous external component for the Argus II system) round out the retinal prosthesis codes. All are non-covered.
Artificial iris devices — The CustomFlex Artificial Iris is named directly. The covered indications that surgeons most commonly pursue—anterior segment reconstruction, aniridia, post-operative or traumatic aphakia, and other iris defects—are each explicitly called out as non-covered. CPT codes 0616T, 0617T, 0618T, and 66683 all fall under the non-covered designation. HCPCS C1839 covers the iris prosthesis device itself and is equally excluded.
The real issue here is that the ICD-10 diagnosis codes associated with these procedures span a wide range of legitimate clinical conditions. Coloboma of the iris (Q13.0), absence of the iris (Q13.1), Rieger's anomaly (Q13.81), traumatic aphakia (H27.0–H27.3), diabetic retinopathy across all diabetes types (E08–E13 ranges), and retinal detachment codes (H33.001–H35.9) are all listed. But a valid diagnosis does not create a covered claim when the procedure itself is classified experimental. Matching your ICD-10 to the right code won't save these claims.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| Artificial retina (e.g., Argus II) — any indication | Not Covered / Experimental | 0100T, 0472T, 0473T, C1841, C1842, L8608 | Classified experimental and investigational; no covered pathway |
| Artificial iris (e.g., CustomFlex) — anterior segment reconstruction | Not Covered / Experimental | 0616T, 66683, C1839 | Explicitly listed as non-covered |
| Artificial iris — aniridia | Not Covered / Experimental | 0616T, 66683, C1839, Q13.1 | Congenital absence of iris is not a covered indication |
| Artificial iris — post-operative or traumatic aphakia | Not Covered / Experimental | 0617T, 0618T, 66683, H27.0–H27.3 | Aphakia diagnosis does not unlock coverage |
| Artificial iris — other iris defects | Not Covered / Experimental | 0616T, 0617T, 0618T, C1839, H21.0–H21.9 | Broad exclusion covers the full H21 code range |
| Retinal prosthesis with IOL exchange or secondary IOL | Not Covered / Experimental | 0617T, 0618T | Combination procedures are equally excluded |
Aetna Artificial Retina and Artificial Iris Billing Guidelines and Action Items 2025
The effective date of November 27, 2025 is your line in the sand. Here's exactly what to do before and after that date.
| # | Action Item |
|---|---|
| 1 | Pull your Aetna claim history for CPT codes 0100T, 0472T, 0473T, 0616T, 0617T, 0618T, and 66683 now. Identify any pending or recently submitted claims. If they haven't adjudicated, expect denial. If they have paid, watch for potential recoupment requests—though this is a policy update, not a retroactive correction. |
| 2 | Update your charge capture system to flag all seven CPT codes and four HCPCS codes (C1839, C1841, C1842, L8608) as non-covered for Aetna plans before November 27, 2025. Don't wait. Set these codes to generate a pre-submission alert for your billing team. |
| 3 | Brief your surgical scheduling team on the patient counseling obligation. When a patient has Aetna coverage and needs an artificial iris or retinal prosthesis, your front-end staff must communicate before surgery that coverage is excluded. Inform patients in writing. Document that conversation. This reduces billing disputes and protects the practice when patients receive unexpected out-of-pocket bills. |
| 4 | Stop submitting prior authorization requests for these procedures under Aetna plans. Prior auth won't help when the payer has classified the procedure as experimental. You're spending staff time on requests that will return non-covered determinations. Redirect that effort to identifying whether the patient has secondary coverage or qualifies for manufacturer patient assistance programs—both the Argus II and CustomFlex have had programs in the past. |
| 5 | Check whether any Aetna plan types in your payer mix have carve-outs. Self-funded employer plans sometimes follow different rules than fully insured Aetna products. Your Aetna contract or the plan documents will specify. This is worth a call to your Aetna provider relations contact before assuming universal non-coverage across all plan types. |
| 6 | Review your artificial iris and retinal prosthesis billing guidelines with your compliance officer if you've been collecting these codes regularly. If your practice has a meaningful volume here, a compliance review before the effective date protects you from accumulating a denial pattern that flags your billing profile. This is especially true if you've been billing C1841 or C1842 alongside covered surgical codes and receiving partial payment. |
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
CPT, HCPCS, and ICD-10 Codes for Artificial Retina and Artificial Iris Under CPB 0713
Not Covered CPT Codes
| Code | Description |
|---|---|
| 0100T | Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intraocular retinal electrode array |
| 0472T | Device evaluation, interrogation, and initial programming of intra-ocular retinal electrode array (e.g., retinal prosthesis) |
| 0473T | Device evaluation and interrogation of intra-ocular retinal electrode array (e.g., retinal prosthesis) |
| 0616T | Insertion of iris prosthesis, including suture fixation and repair or removal of iris, when performed |
| 0617T | Insertion of iris prosthesis with removal of crystalline lens and insertion of intraocular lens |
| 0618T | Insertion of iris prosthesis with secondary intraocular lens placement or intraocular lens exchange |
| 66683 | Implantation of iris prosthesis, including suture fixation and repair or removal of iris, when performed |
Not Covered HCPCS Codes
| Code | Description |
|---|---|
| C1839 | Iris prosthesis (artificial iris devices) |
| C1841 | Retinal prosthesis, includes all internal and external components |
| C1842 | Retinal prosthesis, includes all internal and external components; add-on to C1841 |
| L8608 | Miscellaneous external component, supply or accessory for use with the Argus II retinal prosthesis system |
Key ICD-10-CM Diagnosis Codes
These are the diagnosis codes Aetna associates with this policy. A valid diagnosis in these ranges does not create coverage—the procedures remain excluded regardless.
| Code | Description |
|---|---|
| E08.311–E08.39 | Diabetes mellitus due to underlying condition with ophthalmic complications (retinopathy) |
| E09.311–E09.39 | Drug or chemical induced diabetes mellitus with ophthalmic complications (retinopathy) |
| E10.311–E10.39 | Type 1 diabetes mellitus with ophthalmic complications (retinopathy) |
| E11.311–E11.39 | Type 2 diabetes mellitus with ophthalmic complications (retinopathy) |
| E13.311–E13.39 | Other specified diabetes mellitus with ophthalmic complications (retinopathy) |
| H21.0–H21.9 | Other disorders of iris and ciliary body |
| H27.0–H27.3 | Aphakia (post-operative or traumatic) |
| H31.101–H31.129 | Choroidal degeneration |
| H33.001–H35.9 | Retinal detachments and breaks, retinal vascular occlusions, and other retinal disorders |
| Q13.0 | Coloboma of iris |
| Q13.1 | Absence of iris |
| Q13.2 | Other congenital malformations of iris |
| Q13.81 | Rieger's anomaly |
Get the Full Picture
Track this policy across versions, search 1,500+ policies by CPT code, and get real-time alerts when any payer changes coverage.