Is an artificial iris device, such as the CustomFlex Artificial Iris, medically indicated for a patient with a history of angle closure and consistently dilated pupils, who experiences blurred vision and glare from car headlights, and is scheduled for cataract removal surgery?

Artificial Iris Prosthesis is NOT Medically Indicated Based on Current Payer Policy, Despite FDA Approval and Clinical Evidence Supporting Its Use

The Aetna policy classifying artificial iris devices as experimental/investigational/unproven directly conflicts with FDA approval and published clinical evidence demonstrating safety and efficacy for this exact indication. This creates a coverage denial situation that requires appeal with supporting documentation.

The Coverage Contradiction

Payer Position

• Aetna considers the CustomFlex Artificial Iris experimental/investigational/unproven for anterior segment reconstruction and treatment of iris defects 1
• This policy classification will result in denial of the C1839 iris prosthesis code regardless of clinical appropriateness 1

Clinical Reality

• The CustomFlex Artificial Iris received FDA approval following a successful multicenter clinical trial demonstrating both safety and efficacy 2
• The FDA trial showed 59.7% reduction in marked-to-severe daytime light sensitivity (P < 0.0001) and 48.5% reduction in severe nighttime glare (P < 0.0001) at 12 months 2
• Quality of life improved by 15.4 points on the NEI VFQ-25 (P < 0.0001), with 93.8% of patients reporting improved cosmesis 2
• The device met all key safety endpoints with median endothelial cell loss of only 7.2% at 12 months—comparable to standard cataract surgery 2

Patient-Specific Clinical Justification

This Patient's Presentation Matches FDA-Approved Indications

• Chronic pupillary dilation following angle closure creates functional aniridia with disabling glare symptoms 2
• The patient reports glare from car headlights impacting driving ability—a functional impairment directly addressed by artificial iris implantation 2, 3
• Blurred vision and ADL limitations meet the symptomatic criteria established in the FDA trial 2

Alternative Treatments Are Inadequate

• Changing glasses will not address the fundamental problem of excessive light entering through the permanently dilated pupil 2
• Specialty contact lenses with artificial pupils are an alternative but have significant limitations in comfort, maintenance, and optical quality 3
• The patient's history of angle closure 2 years ago suggests structural anterior segment abnormalities that make contact lens fitting challenging 1

Angle Closure History Considerations

Surgical Planning Implications

• The prior angle closure episode requires careful preoperative gonioscopy and anterior segment imaging to assess current angle anatomy 1
• Patients with angle closure history may have persistent narrow angles, peripheral anterior synechiae, or plateau iris configuration that affects surgical approach 1
• Combined cataract extraction addresses both the cataract and any residual angle crowding from lens-related mechanisms 1

Iris Prosthesis Compatibility

• The permanently dilated pupil suggests sphincter damage or posterior synechiae from the prior angle closure episode 1
• Artificial iris implantation is technically feasible in eyes with prior angle closure, though careful attention to anterior chamber depth and angle anatomy is required 2, 4
• The prosthesis can be implanted through the same incision as the IOL using specialized techniques to minimize surgically induced astigmatism 5

Evidence-Based Outcomes Data

Safety Profile

• No device-related loss of corrected distance visual acuity >2 lines in the FDA trial 2
• Endothelial cell loss (7.2% at 12 months) is within acceptable limits for intraocular surgery 2
• Complication rates were low across multiple surgical techniques 2

Functional Improvement

• Marked reduction in both daytime and nighttime glare symptoms that specifically impact driving 2
• Improvement in health-related quality of life measures 2, 6
• High patient satisfaction rates (93.8%) with cosmetic and functional outcomes 2

Real-World Experience

• Multiple case series confirm effectiveness in traumatic and non-traumatic iris defects 4, 3, 6
• Bilateral implantation studies show consistent benefit across different etiologies of iris defects 6
• The device provides effective treatment when nonsurgical means (contact lenses, corneal tattooing) are inadequate 3

Recommendation for Authorization

Despite the Aetna policy classification, this case warrants approval based on:

1. FDA approval status demonstrating the device is not experimental 2
2. Published Level 1 evidence from the FDA clinical trial showing significant functional improvement in the exact symptoms this patient experiences 2
3. Impact on activities of daily living, specifically driving safety, which represents a quality of life and safety concern 2
4. Lack of effective alternatives for functional aniridia with disabling glare 3

Appeal Strategy

• Submit the FDA trial results showing statistically significant improvement in glare and light sensitivity 2
• Document the functional impairment (driving limitations) and its impact on independence and safety 2
• Emphasize that the device has completed FDA approval process and is not investigational 2
• Include comparative data showing artificial iris superiority over contact lens alternatives for this indication 3

Critical Caveat

The cataract removal is appropriately approved, but the iris prosthesis denial will likely stand under current Aetna policy unless successfully appealed with the evidence cited above. The disconnect between payer policy and FDA approval/clinical evidence creates an administrative rather than medical barrier to this medically appropriate intervention 2.