LumiThera, Inc., a medical device company commercializing a photobiomodulation (PBM) treatment for ocular damage and disease, announced a new Category III CPT code effective January 1, 2025.
The AMA’s CPT Editorial Panel considered and approved the company’s application for a code to report “Photobiomodulation therapy of retina, single session” at the May 2024 meeting.1
Support for this new Category III code came from many sources; one was LumiThera’s clinical trial. LIGHTSITE III was a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center clinical trial conducted at ten leading US retinal centers. The purpose was to assess the safety and efficacy of photobiomodulation treatment in patients with dry age-related macular degeneration (AMD). The primary efficacy endpoint, best corrected visual acuity (BCVA), was evaluated at 13 months and was significantly improved (p < 0.025). The trial continued for a total 24 months. The 24-month data showed minimal safety risks and high patient compliance with over 80% of the patients completing the six rounds of Valeda PBM treatment sessions.
The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group in the modified intent to treat population with at least 1 post-treatment visit and disease consistent with early/intermediate dry AMD. The results demonstrated statistically significant improvement in the primary endpoint in BCVA at 13 months in the PBM treatment group over the sham-treatment group (p < 0.025). A mean increase in ETDRS letter score of >5.0 letters from baseline was seen at both the 13- and 21-month timepoints in the PBM-treated subjects' BCVA (p < 0.0001). Less patients progressed to new geographic atrophy, a later stage scar that is seen with the permanent loss of retinal tissue.
“Establishing a unique CPT code for PBM use in retina is a positive step toward reimbursement,” stated Kevin J. Corcoran. Kevin is a Principal for Corcoran & Corcoran, a leading advisor on reimbursement for ophthalmic products and services. He said, “Not every application for a new CPT code is successful. Those that succeed, like this one, have support from the professional societies as well as evidence-based medicine published in the scientific literature.”
“In parallel with our De Novo submission to the FDA, this is another important step for dry AMD patients experiencing vision loss who currently have limited treatment options. LumiThera wants patients to have access to non-invasive Valeda treatments to improve vision and address the disease earlier in the process,” stated Clark Tedford, PhD, LumiThera president and CEO.
Reference
- AMA. Summary of action of CPT Editorial Panel. https://www.ama-assn.org/system/files/may-2024-summary-of-panel-actions.pdf Accessed 8/6/24