Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Macular degeneration
Issue under review:  Foresee home device

Determination:  The Foresee home device is not medically necessary.

The patient is an adult female.  An exam documents the patient presenting for evaluation of dry age-related macular degeneration.  Vision was 20/25 OU (both eyes).  Macular drusen and RPE (retinal pigment epithelium) changes were noted OU.  Provider recommended exploring whether the ForeseeHome device was covered by insurance.  Else, patient was to check with Amsler grid three times/week and follow up in six months. 

An exam documents history of dry age-related macular degeneration and vision corrected to 20/20 OU.  Pigment mottling was noted in maculae of both eyes. 

An exam documents patient presenting for evaluation of dry age-related macular degeneration.  Vision was 20/25+2 OD (right eye) and 20/25 OS (left eye).  Dilated fundus exam found changes of the retina pigment epithelium and drusen OU.  Fluorescein angiography did not identify vascular leakage.  Provider recommended continued use of Foreseehome device and checking with an Amsler grid three times/week.   

An exam documents the patient presenting for evaluation of dry age-related macular degeneration. On exam, vision was documented as 20/20-2 OD and 20/25 OS. Macular drusen were identified on dilated fundus exam and confirmed by OCT (optical coherence tomography). Six-month follow up was recommended. Patient was advised to use sunglasses when outdoors, take macular vitamins, monitor BP, avoid tobacco use, use Amsler grid three times/week to monitor for distortion. 

An exam documents patient presenting for a follow up to monitor intermediate dry macular degeneration of both eyes.  On exam, vision was 20/30 OD and 20/25 OS.  Macular drusen were noted bilaterally and were characterized by OCT as stable.

Current monitoring of patients at risk for CNV (choroidal neovascularization) development consists of periodic in-office examinations at varying intervals by ophthalmologists and optometrists with the recommendation for self-monitoring of visual function including either new onset or changes in existing symptoms.  This may include use of an Amsler grid. 

According to the AAO, electronic monitoring devices are available to aid in detection of neovascularization at an early stage.  Such devices use hyperacuity perimetry (or vernier acuity) to create a quantified central visual map of metamorphopsia. 

The results of the HOME Study, a Phase 3 unmasked, randomized trial evaluating role of home monitoring with FH device plus standard care compared to standard care alone for eyes at risk of developing CNV have been reported.  The FH device utilizes preferential hyperacuity perimetry and tele-monitoring to detect changes in vision function associated with development of CNV, potentially prior to symptom and visual acuity loss.  After establishing baselines, subsequent changes on follow-up are detected, causing monitoring center to alert clinical center to recall participants for an exam. Standard care consists of instructions for self-monitoring visual changes with subsequent self-reporting. 

The primary analysis achieved statistical significance, with participants in the device arm demonstrating a smaller decline in visual acuity with fewer letters lost from baseline to CNV detection, resulting in better visual acuity at CNV detection in the device arm.  The Committee recommended early study termination for efficacy.  The authors concluded that persons at high risk for CNV benefit from the home monitoring strategy for earlier detection of CNV development, which increases the likelihood of better visual acuity results after intravitreal anti-VEGF therapy. 

Limitations of the study include decreased generalizability of results for all persons with intermediate AMD as an anticipated number of participants may not successfully pass the screening for the testing.  Thus, such testing is unproven and is not medically necessary.