LumiThera, Inc. announced that the American Medical Association (AMA) has approved a new Category III Current Procedural Terminology (CPT) code supporting photobiomodulation (PBM) treatment.
First, explain Category III CPT codes.
The AMA’s 21-member CPT Editorial Panel is responsible for all revisions, updates, and modification of CPT codes, descriptors, rules, and guidelines.
In the case of Category III CPT codes: These are temporary alphanumeric codes that enable data collection on new and emerging technologies, services, and procedures.
- Such data can be used to:
- Assess new services and procedures
- Justify establishing a permanent Category I CPT code
- Support widespread usage in the FDA approval process
And in this case?
Following its May 2024 meeting, the AMA CPT Editorial Panel accepted 16 Category III codes, including our code of interest: Photobiomodulation therapy of retina, single session (#0936T).
Alrighty, so how does LumiThera play into this?
LumiThera originally submitted an application to support the new Category III CPT code.
Why: PBM therapy is the core of LumiThera’s Valeda Light Delivery System (VLDS), a multi-wavelength and non-invasive treatment incorporating multiwavelength PBM.
- Its intended indication: To treat dry age-related macular degeneration (AMD).
Talk more about this system.
The VLDS uses a light-emitting diode system with three wavelengths (590 nm, 660 nm, and 850 nm) to carry a non-coherent, eye-safe column of light to deliver treatment to the eye via either an open or closed eyelid.
The process: The system works in less than 5 minutes and can be done on a non-dilated pupil.
- In total: Nine applications are needed over a 3-week period, with additional treatments on follow-up visits.
And its regulatory status?
The system was the first to be CE-approved in the European Union and is currently authorized for investigational use only in the United States.
- Along those lines: In January 2024, the company submitted a De Novo request to the FDA with the intent to reclassify VLDS as a Class II device.
Gotcha. Now let’s circle back to this CPT code. What led to its approval?
Among several sources, clinical data from the company’s LIGHTSITE III study (NCT04065490).
About that trial:
- The design: Double-masked, randomized, sham-controlled, parallel group, multicenter study
- The participants: 100 patients with early-to-intermediate dry AMD
- The setup: PBM treatment or sham applied every 4 months, with the last administered at 21 months and follow-up at 24 months
- Primary endpoint: Best-corrected visual acuity (BCVA)
And those findings?
First: As reported in March 2023, 24-month data was based on an analysis of 143 eyes (91 in PBM group; 54 in sham group).
The initial data: A sustained and statistically significant improvement was initially observed in the BCVA at Month 13 in the PBM treatment group (vs sham group) plus in visual acuity at Month 21.
Then: A mean increase in ETDRS letters score >5.0 letters from baseline was reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA.
- See the complete findings, including insight from LumiThera President and CEO Clark E. Tedford, PhD.
That sounds very promising.
Indeed. And that’s not even considering the first two LIGHTSITE trials:
- LIGHTSITE I (NCT02725762)
- LIGHTSITE II (NCT03878420)
To note: Both studies demonstrated sustained improvements in visual benefits and concluded PBM could be considered a therapeutic treatment option for dry AMD.
That’s good to hear … so what’s significant about this CPT code?
A few things … with the first noted as this being a “positive step toward reimbursement” for PBM use in retina.
Plus, when considering LumiThera’s De Novo submission, it’s also critical for dry AMD patients with limited treatment options, according to Tedford.
“LumiThera wants patients to have access to non-invasive Valeda treatments to improve vision and address the disease earlier in the process,” he stated.
Speaking of access … when is this code effective?
While the AMA released it on July 1, 2024, it won’t go into effect until Jan. 1, 2025.