Photobiomodulation (PBM) is a new FDA authorized1 treatment available for patients with dry age-related macular degeneration (AMD). In this article we’ll discuss the procedure and the documentation, coding and coverage instructions for billing for this technology.
PBM is the use of low levels of light to stimulate cellular activity and provide beneficial effects. The light delivery system delivers low-intensity, non-coherent, multi-wavelengths of light at 590, 660, and 850 nm to the retinal tissue, stimulating mitochondrial metabolic activity, increasing available energy for the cells and reducing oxidative stress and inflammation. This is done to improve vision in eyes with early- and intermediate-stage nonexudative (dry) AMD.
Patients with dry AMD treated with PBM have shown improvements in clinical, anatomic, and quality-of-life assessments. PBM acts at the mitochondrial level by improving cellular output and reestablishing metabolic function.2
Indications and Use
PMB is intended to provide improved visual acuity in patients with best-corrected visual acuity (BCVA) of 20/32 through 20/70 and who have dry AMD characterized by:
- The presence of at least 3 medium drusen (> 63 μm and ≤ 125 μm in diameter), or large drusen (> 125 μm in diameter), or non-central geographic atrophy, and
- The absence of neovascular maculopathy or center-involving geographic atrophy.
After about 2 years, the treatment provides improved mean visual acuity of approximately 1 line (ETDRS) compared to those not receiving the treatment.
In the LIGHTSITE III3 clinical trial, subjects received PBM treatment with the Valeda (LumiThera, Inc.) in 9 sessions over 3 to 5 weeks every 4 months, over a period of 24 months.
PMB is usually performed in an office or out-patient setting; no anesthesia is required. State laws and licenses for nurse practitioners, physician assistants and optometrists vary greatly, and may preclude those providers from performing PBM. You are encouraged to thoroughly research this before proceeding with these providers involved.
Likewise, most states place strict limits on the role of medical assistants. They may work directly with doctors, as support staff; they cannot give medical advice to patients. Even certified ophthalmic assistants and technicians are limited in what tasks they can perform.
Documentation and Coding
PBM is a minor procedure, not a major surgery, that is supported by an operative report in the medical record. The essential elements of the note include: date of service, patient name, diagnosis, proceduralist’s name, title of procedure, indication for the procedure, description of the procedure, discharge instructions, and signature.
If an office visit occurs on the same day as PBM, follow the minor surgery billing rules when considering a charge. Same day exams that qualify as “separately identifiable services” are billable; append modifier -25. Exams to determine the need to treat same day, are not billable.
Effective January 1, 2025, PMB is assign Category III CPT code 0936T. (Photobiomodulation therapy of retina, single session). A session occurs on a single day. On claims for reimbursement, report the appropriate ICD-10-CM code from the H35.31- series to describe nonexudative age-related macular degeneration. Report the diagnosis code to the highest level of specific. The ICD-10 code’s sixth digit is needed to identify the eye(s): 1 for right eye, 2 for left eye, 3 for both eyes. The seventh digit identifies the stage of the disease. The number 1 in the seventh digit means early dry stage and the number 2 means intermediate stage dry AMD.
Category III codes can cause confusion when it comes to billing. Contrary to common belief, services reported with Category III codes are not automatically considered non-covered. Unless the payer has specifically identified the service as non-covered, a claim is expected.
There is compelling evidence to support coverage of PBM in an office setting for qualifying patients, as PBM is the first treatment shown to improve vision loss associated with dry AMD. Despite that, coverage for category III codes is often uncertain.
Florida Medicare, First Coast Solutions’ new process for CPT category III codes4 requires documentation be submitted with claims for Category III codes. It states:
Effective February 26, 2024, when records are not submitted to support the code billed (of T codes linked below), the service will be rejected. The claim must then be resubmitted with the appropriate information.
First Coast requests the following documentation:
- History and physical examination
- Lab or diagnostic test results, if applicable
- Progress or office notes for the service performed
- Operative or procedure report, if applicable
- Full text peer-reviewed articles
- Society guidelines
- Any additional documentation that supports the need for the service
Aetna’s “Age-Related Macular Degeneration Clinical Policy” last updated in February, 2025 list code 0936T as non-covered.4
For Medicare Part B, each Medicare Administrative Contractor (MAC) determines the payment rate for Category III codes; CMS did not establish a rate in the CY 2025 Medicare Physician Fee Schedule.
When Medicare or other third-party payors will likely deny the claim, ask the patient to assume responsibility for the charge using a financial waiver: An Advanced Beneficiary Notice of Noncoverage (ABN) is required for services where Part B Medicare coverage is ambiguous or doubtful. For Medicare Advantage (Part C), determination of benefits is required to identify beneficiary financial responsibility prior to performing noncovered services; MA Plans have their own waiver forms and processes. For commercial insurance beneficiaries, a Notice of Exclusion from Health Plan Benefits (NEHB) is an alternative to the ABN.
Conclusion
PBM represents an exciting advancement in eye care for the millions of people in the United States with dry AMD. As with any new technology, some work is needed prior to introducing it in your practice. Physicians and practice administrators should take the time to investigate any state specific limitations to who can perform these services. Additionally, do your due diligence with the payors regarding coverage and payment rates. Where coverage is uncertain, obtain a signed waiver from the patient. OP
REFERENCES:
1. LumiThera Inc. LumiThera obtains FDA authorization of Valeda treatment for dry AMD patients to improve vision. News release. November 4, 2024. https://www.businesswire.com/news/home/20241104299697/en/LumiThera-Obtains-FDA-Authorization-of-Valeda-Treatment-for-Dry-AMD-Patients-to-Improve-Vision
2. Kaymak H, Schwahn H. Photobiomodulation as a treatment in dry AMD. Retina Today. May/June 2020. Accessed May 15, 2025. https://retinatoday.com/articles/2020-may-june/photobiomodulation-as-a-treatment-in-dry-amd#:~:text=Photobiomodulation%20%28PBM%29%2C%20as%20performed%20with%20the%20Valeda%2C%20acts,shown%20improvements%20in%20clinical%2C%20anatomic%2C%20and%20quality-of-life%20assessments
3. Boyer D, Hu A, Warrow D, et al. LIGHTSITE III: 13-Month efficacy and safety evaluation of multiwavelength photobiomodulation in nonexudative (dry) age-related macular degeneration using the Lumithera Valeda Light Delivery System. Retina. 2024;44(3):487-497. doi:10.1097/IAE.0000000000003980
4. Aetna process for Category III codes. https://medicare.fcso.com/Billing_news/0508074.asp
As of July 7, 2025, Alcon announced its intention to acquire LumiThera, Inc. and its photobiomodulation (PBM) device (https://tinyurl.com/mr37k6jf)
