Scope: This policy defines Aetna's medical necessity criteria for management of Age-Related Macular Degeneration (ARMD), including therapies for neovascular (wet) ARMD and specific selection, eligibility, and contraindication criteria for the Implantable Miniature Telescope (IMT) monocular implant in members aged 65 years and older (coverage limited to ages ≥ 65 years). Status: CURRENT. Subject: Age-Related Macular Degeneration (ARMD) treatments and Implantable Miniature Telescope (IMT).

High-level coverage stance: Aetna's coverage is mixed. Medically necessary therapies listed for neovascular (wet) ARMD include aflibercept, bevacizumab, pegaptanib sodium, photodynamic therapy (PDT) with verteporfin, ranibizumab, and brolucizumab when criteria are met. The IMT is covered for monocular implantation when ALL specified pre-operative selection criteria and age/visual acuity thresholds are met. Numerous diagnostics and interventions (e.g., various genetic tests, home hyperacuity monitoring, microperimetry, AI-based detection, stem cell transplantation, complement inhibitors, photobiomodulation, gene therapy, epimacular brachytherapy, and others) are designated experimental and investigational because effectiveness has not been established.

IMT high-level note: The IMT is an FDA-approved monocular intraocular telescope prosthesis for end-stage ARMD with bilateral central scotoma; coverage requires demonstration of pre-implantation improvement with an external telescope (at least a 5-letter ETDRS improvement), other pre-surgical tests/training, specified binocular visual acuity range (worse than 20/160 but not worse than 20/800 in both eyes), absence of active CNV, and fulfillment of device-specific anatomic and endothelial cell density thresholds.

Not covered codes: The policy lists specific CPT, HCPCS, and ICD-10 code groups marked as not covered for the indications in this CPB, including CPT codes for experimental diagnostics and tests (e.g., 0378T, 0379T, 0506T, 0205U), additional CPT/other procedure codes noted in the policy listing (e.g., codes related to stem cell or radiation therapies), HCPCS/J-codes not covered (e.g., J3300, J3301, J9212–J9215, S2140, S2150, S9559), and ICD-10 ranges listed as not covered for the specified indications (e.g., H35.051–H35.059, H35.30, H35.3110–H35.3194).

Background: ARMD is a progressive degenerative disease of the macula and a leading cause of blindness in developed countries, primarily affecting people aged 60 years and older; risk increases with age and certain exposures (e.g., heavy alcohol use). The disease spectrum includes early (few medium drusen or pigmentary changes), intermediate (large drusen or geographic atrophy not involving the center), and late/advanced ARMD which may be non-exudative (dry, atrophic) or neovascular/exudative (wet).

Dry vs wet ARMD: The non-neovascular (dry) form causes slow, progressive macular deterioration with drusen and geographic atrophy. The neovascular (wet) form involves development of choroidal neovascularization (CNV) with leakage of blood and fluid, serous or hemorrhagic retinal pigment epithelial detachments, and scar formation, accounting for most cases of severe vision loss. Approximately 10–20% of patients with non-exudative ARMD progress to the exudative form.

Risk factors and natural history: ARMD risk rises with age; environmental and genetic factors contribute. Dry ARMD gradually worsens over years, while conversion to wet ARMD with CNV can cause rapid central vision loss.

Evolution of treatments: Historically, argon laser photocoagulation and submacular surgery were used but have limited roles due to harm or lack of benefit. Photodynamic therapy (PDT) with verteporfin limited visual loss in wet ARMD but typically does not improve vision. The advent of intravitreal anti-VEGF pharmacotherapies (pegaptanib, ranibizumab, bevacizumab, aflibercept, brolucizumab, and newer agents like faricimab) transformed management of neovascular ARMD, substantially reducing VA loss and providing VA gains with appropriate dosing regimens (e.g., VIEW trials for aflibercept; CATT comparing ranibizumab and bevacizumab).

Emerging and surgical options: For patients with refractory/end-stage central vision loss, intra-ocular devices such as the Implantable Miniature Telescope (IMT) have been developed and FDA-approved for selected older patients; IMT clinical trials (IMT-002 and follow-ups) demonstrated VA and quality-of-life improvements but also notable endothelial cell loss and potential corneal complications, informing strict selection and follow-up criteria.

IMT: Implantable Miniature Telescope — a monocular intraocular telescope prosthesis for end-stage ARMD with central scotoma.

ETDRS: Early Treatment Diabetic Retinopathy Study visual acuity chart.

CNV: Choroidal neovascularization — pathologic new blood vessel growth beneath the retina responsible for neovascular (wet) ARMD.

ECD: Endothelial cell density (cells/mm2) — corneal endothelial cell count used to assess suitability for IMT implantation.

AREDS2: Age-Related Eye Disease Study 2 — major randomized trial evaluating nutritional supplementation for ARMD.

GA: Geographic atrophy — an advanced atrophic form of AMD (non-exudative).

MNV / CNV: Macular neovascularization / choroidal neovascularization (neovascular or 'wet' AMD).

IRF: Intra-retinal fluid.

SHRM: Subretinal hyperreflective material.

ORT: Outer retinal tubulation.

HF: Hyperreflective foci.

NLR: Neutrophil-to-lymphocyte ratio — defined as neutrophil count divided by lymphocyte count.

AREDS formulation: Antioxidant and zinc supplement formulation used in AREDS trials; AREDS2 formulation includes lutein/zeaxanthin and 80 mg zinc oxide.