What Is Considered Off-Label Use
ForeseeHome is cleared by the FDA for the monitoring of patients with intermediate dry AMD, who we know are at risk of conversion to wet AMD. The technology and the complementary services provided by the Notal Vision Monitoring Center provide a tremendous benefit to patients, effectively helping to preserve their vision and thus their quality of life.
However, the Monitoring Center receives referrals that are not considered “on-label”. These include any ICD-10 diagnosis codes that are not specifically indicated for dry intermediate AMD, and therefore not covered by Medicare.
A question we’ve received from some doctors is “Now that I have injected my neovascular AMD patient a number of times and the retina is completely dry with good visual acuity, can I monitor (or continue to monitor) this eye with ForeseeHome?”
The answer is "no" for three reasons:
- Medicare approves ForeseeHome to monitor for dry intermediate AMD using codes H35.3112 for right eye, H35.3122 for left eye, and H35.3132 for both eyes. Therefore, the Notal Vision Monitoring Center is obliged to close, or stop testing, an eye that has developed wet AMD even if the retina is dry post-treatment. If the fellow eye has dry AMD, monitoring can certainly continue in that eye. If only one eye is testing and that eye develops wet AMD, the patient will terminate testing and return the device.
- A small study was done in house to investigate whether ForeseeHome monitoring was useful or effective in wet AMD prior to its clearance. That study showed that there was too much variability in testing to be useful. Some eyes that were dry post-treatment alerted when fluid returned, while others did not. In addition, a significant number of eyes were unable to establish a new baseline, and a new baseline is required after an alert to resume testing. Learn more about alerts here.
- All the compelling data that we have seen regarding ForeseeHome and its ability to help eye care providers diagnose wet AMD early when the vision is still good, have been done on dry intermediate patients such as in the HOME study1 and most recently in “Real-World Performance of a Self-operated Monitoring System for Early Detection of Choroidal Neovascularization in AMD.”2 In this most recent retrospective study published in March 2021, 81% of the dry intermediate AMD patients for whom the ForeseeHome monitoring program was added to their standard of care maintained functional vision, compared to 34% who maintained functional vision in the American Academy of Ophthalmology’s IRIS Registry.3
Notal Vision is happy to provide our monitoring service to all your intermediate AMD patients, empowering them to take an active role in preserving their vision and giving you a better opportunity to diagnose earlier for timely treatment while their vision is still good.
Questions for the Medical Directors?
- Chew EY, Clemons TE, Bressler SB, et al; AREDS2-HOME Study Research Group. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study. Ophthalmology. 2014;121(2):535-544.
- Ho AC, Heier JS, Holekamp NM, Garfinkel RA, Ladd B, Awh CC, Singh RP, Sanborn GE, Jacobs JH, Elman MJ, Loewenstein A, Eichenbaum DA. Real-World Performance of a Self-Operated Home Monitoring System for Early Detection of Neovascular Age-Related Macular Degeneration. Journal of Clinical Medicine. 2021; 10(7):1355
- Ho AC, Kleinman DM, Lum FC, Heier JS, Lindstrom RL, Orr SC, Chang GC, Smith EL, Pollack JS. Baseline Visual Acuity at Wet AMD Diagnosis Predicts Long-Term Vision Outcomes: An Analysis of the IRIS Registry. Ophthalmic Surg Lasers Imaging Retina. 2020 Nov 1;51(11):633-639. doi: 10.3928/23258160-20201104-05. PMID: 33231696.