LumiThera announces new Category III CPT code
The CPT code is the first to report photobiomodulation therapy in retinal disease.
(Image credit: AdobeStock/NINENII)
LumiThera, Inc., a medical device company commercializing a photobiomodulation (PBM) treatment for ocular damage and disease, announced a new Category III CPT code. The announcement comes after the AMA’s CPT Editorial Panel approved the company’s application for the code during a meeting back in May. The code is set to go into effect on Jan. 1, 2025.
Kevin J. Corcoran, a principal for Corcoran & Corcoran and leading advisor on reimbursement for ophthalmic products and services, said, “Establishing a unique CPT code for PBM use in retina is a positive step toward reimbursement. 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.”
Backing for the new code was a result of LumiThera’s clinical trial for the treatment. Titled LIGHTSITE III, it was a prospective, double-masked, randomized, sham-controlled, parallel group, multi-center clinical trial conducted at 10 leading retinal centers in the US. The trial’s purpose was to assess the safety and efficacy of photobiomodulation treatment in patients with dry age-related macular degeneration (AMD). Lasting for a total of 24 months, the data showed minimal safety risks and high patient compliance, with over 80% of patients completing the 6 rounds of the treatment.
The trial included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group, with the modified intent to treat the patients with at least 1 post-treatment visit and disease consistent with early or intermediate dry AMD. The results proved significant improvement in the primary endpoint in BCVA at 13 months in the PBM treatment group over the sham-treatment group.
“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,” said Clark Tedford, PhD, LumiThera President and CEO.
