Insufficient Documentation Precludes Approval for Encelto Implantation
Based on the provided clinical information, this request for Encelto (revakinagene taroretcel-lwey) cannot be approved due to inadequate documentation to verify that the patient meets established medical necessity criteria for idiopathic macular telangiectasia type 2 (MacTel).
Critical Missing Documentation
The American Academy of Ophthalmology requires comprehensive documentation including formal visual acuity measurements and fluorescein angiography to confirm MacTel diagnosis and exclude mimicking conditions such as diabetic macular edema, vein occlusions, and inflammatory conditions 1. The current submission contains only:
- Email communication with diagnosis statement
- OCT images described as "dark images only"
- No office visit notes
- No fluorescein angiography results
- No formal ETDRS visual acuity measurements
- No spectral domain-OCT measurements of ellipsoid zone loss
Required Criteria Not Documented
For Encelto approval, the following must be documented but are absent:
Diagnostic Confirmation Requirements
- Fluorescein angiography demonstrating fluorescein leakage plus at least one characteristic feature (hyperpigmentation >500 microns from foveal center, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities) 1
- Exclusion of neovascular MacTel (no evidence of intraretinal or subretinal neovascularization, hemorrhage, hard exudate, subretinal fluid, or intraretinal fluid in either eye)
- Exclusion of diabetic retinopathy - particularly critical given patient's diabetes medication (Monjaro) 1
Quantitative Measurements Required
- Photoreceptor IS/OS break area between 0.16 mm² and 2.00 mm² measured by spectral domain-OCT - not provided
- Best corrected visual acuity of 54-letter score or better (20/80 or better) by ETDRS chart - not documented with formal testing
- Steady fixation and clear ocular media for quality photographs - cannot be verified from "dark images"
Additional Exclusion Criteria to Verify
- No intraretinal hyperreflectivity by OCT
- No evidence of central serous chorioretinopathy
- Lens opacity assessment per AREDS grading system
- No glaucoma (patient on multiple cardiovascular medications that could mask symptoms)
- Ability to discontinue antithrombotic therapy perioperatively
Clinical Context Considerations
While the patient's functional impairment is significant (potential job loss as bus driver, difficulty with reading, driving, watching TV), symptomatic severity alone does not establish medical necessity without objective diagnostic confirmation 1. The natural history of MacTel type 2 shows that most eyes with good baseline vision retain stable visual status over 3 years, with only 15% losing ≥2 Snellen lines 2. This underscores the importance of accurate diagnosis before proceeding with a one-time, irreversible gene therapy implant 3.
Common Pitfalls in MacTel Diagnosis
The differential diagnosis must exclude conditions requiring different management 1:
- Diabetic macular edema - patient has diabetes risk factors (on Monjaro)
- Branch retinal vein occlusion - can present with similar visual complaints
- Choroidal neovascularization from other causes
- Inflammatory macular conditions
Without fluorescein angiography, these cannot be definitively excluded 1.
Recommendation for Resubmission
Request comprehensive ophthalmologic evaluation including:
- Complete office visit documentation with detailed fundus examination
- Fluorescein angiography with interpretation
- Formal ETDRS visual acuity testing in both eyes
- High-quality spectral domain-OCT with measurements of ellipsoid zone loss area
- Assessment of all exclusion criteria listed in the coverage policy
- Documentation of steady fixation and media clarity
- Lens opacity grading per AREDS system
Only after complete diagnostic workup confirming non-neovascular MacTel type 2 with quantified disease parameters can medical necessity be established 1, 3.