How to Implement Valeda™ PBM in your Practice: Workflow, Billing, and Patient Selection
3 minute read
Retina specialists Miguel Busquets, MD, FACS, and Rob Foster, MD, share practical guidance for integrating Valeda™ Photobiomodulation (PBM) into clinical workflows, from patient identification and scheduling to reimbursement conversations and ongoing patient support.
Why implementation planning matters
For decades, treatment options for dry age-related macular degeneration (AMD) were limited, with intervention typically reserved for advanced stages of the disease.1-3
That reality is beginning to change with the advent of Valeda™ PBM—the first and only FDA-authorized dry AMD* treatment to improve and maintain vision at 2 years.4 A noninvasive light-based therapy, Valeda PBM applies three scientifically validated wavelengths to restore cellular energy production and improve retinal cellular health.5,6
To help practices think through how they can implement Valeda PBM into their practices, we sat down with Miguel Busquets, MD, FACS, and Rob Foster, MD of Cincinnati Eye Institute (CEI), two of the first retina surgeons to implement the technology into their workflows, to learn how they approached implementation and what they learned along the way. Their insights provide guidance on four key areas: implementation planning, step-by-step workflow, billing and reimbursement, and patient selection.
How Cincinnati Eye Institute implemented Valeda PBM
As with any new treatment, proper implementation requires careful consideration of how Valeda PBM fits into existing workflows and patient care pathways. With patients becoming more informed and engaged than ever, successful implementation starts before the first patient is treated.7 In the case of CEI, this required alignment across the clinical, operational and administrative teams that support the patient journey.
“We approached implementation very deliberately,” said Rob Foster, MD, vitreoretinal specialist. “Before launching PBM, we conducted a strategic evaluation that included providers, operations, finance, scheduling, compliance, and revenue cycle teams. That helped us build a scalable framework before introducing treatment into clinic flow.”
Rather than immediately deploying PBM across all locations, CEI began with a structured pilot program to refine workflows and identify operational challenges early—a process that other practices interested in integrating PBM could duplicate.
Watch Rob Foster, MD share tips to integrate Valeda PBM into your practice
Watch Miguel Busquets, MD on changing the Conversation in Dry AMD Care
Cincinnati Eye Institute’s Implementation planning checklist
Before launching Valeda PBM, CEI took the following steps:
Build cross-functional alignment early. Include providers, technicians, scribes, schedulers, patient educators, billing teams, finance, compliance and revenue cycle stakeholders.
Start with a structured rollout. Begin with a smaller patient cohort or pilot workflow in a single practice location to refine processes before expanding more broadly.
Identify where treatment fits into the clinic schedule. Determine whether Valeda PBM treatments will be scheduled in dedicated time blocks, specific days or alongside existing clinic operations.
Designate a point person for patient education and coordination. A dedicated patient educator or coordinator can support patient questions, scheduling, expectations and follow-up.
Train staff on the patient conversation. Develop a consistent, approved script for explaining what Valeda PBM is, how the treatment schedule works, and what patients can expect during visits.
CEI’s step-by-step Valeda PBM Workflow
No implementation is complete without designing a workflow. Because one treatment course consists of three applications per week, over three consecutive weeks, three times a year,** CEI benefitted from mapping each step of the patient journey before launch—from provider identification to patient education, scheduling, treatment, documentation and follow-up.5
Janelle Ridgeway, a patient educator, works closely with providers like Dr. Foster and patients to help coordinate scheduling, answer questions and streamline the overall treatment experience.
“My role is really to help patients feel informed and comfortable throughout the process,” she explained. “We walk through the treatment schedule, timing, logistics, and what they can expect during visits so there are no surprises.”
Step-by-step workflow checklist
The following workflow can help practices think through what happens before, during, and after the first treatment visit:
Physician identifies a potential patient. The workflow starts when the physician identifies a patient who may be appropriate for Valeda PBM and introduces the option during a routine visit.
Hand off to a patient educator or coordinator. If the patient is interested, the provider or clinic team connects the patient with a designated staff member in person or by phone. The educator provides practice-specific patient education materials that include more detail about what they can expect as they navigate CEI’s individual Valeda PBM treatment workflow.
Confirm patient understanding of the treatment. After reviewing the educational materials with the patient, confirm they understand Valeda PBM is for intermediate dry AMD, then walk through the treatment purpose, visit cadence and expected time commitment. Prepare approved responses for questions about safety and side effects, including approved language that Valeda PBM has a favorable safety profile with no reports of phototoxicity observed in the clinical study.8
Review the treatment schedule. Practices should explain the number of visits and cadence early, so patients understand how often they will be in the office and what to expect when they arrive. Explain to patients that they may be scheduled with different providers throughout their treatment journey to maximize scheduling flexibility.
Confirm required clinical information is current. Before scheduling treatment, practices should confirm that required clinical assessments and imaging are current according to practice protocol.
Schedule with the patient’s availability in mind. Janelle starts by sharing the provider or treatment calendar, which includes appointments from 7:30 a.m. to early evening, five days a week. She then asks patients, “What days don’t work for you?” to avoid unnecessary back-and-forth and create a concierge-style experience.
Document the schedule and treatment milestones. Use the electronic health record and, where appropriate, a separate tracking spreadsheet to monitor treatment dates, completed sessions, scheduling notes and billing-relevant details.
Maintain ongoing communication. Frequent visits make regular communication important. A direct contact or clear follow-up pathway can help patients ask questions as they move through the Valeda PBM treatment course.
Billing and reimbursement considerations for Valeda PBM
For Cincinnati Eye Institute, billing and reimbursement conversations were an important part of implementation because patients often ask about cost and coverage early in the education process. Our experts noted that conversations with their patients typically begin with clinical value, with access and coverage considerations addressed separately.
“Coverage is evolving and can be variable,” shared Miguel Busquets, MD. “It’s important to help patients understand their options and weigh them against the clinical value.”
CEI’s billing and reimbursement checklist
CEI aligned internally on how billing and reimbursement conversations would be handled before patients began treatment:
Decide who owns reimbursement conversations. Identify whether billing staff, revenue cycle, a patient educator or another designated team member will explain cost, coverage and payment logistics. Typically, a provider can share basic information about cost, referring patients to a patient educator for more detailed discussions.
Separate clinical value from coverage logistics. Keep the clinical conversation focused on why the provider believes treatment may be appropriate, then address cost, access and coverage through the appropriate practice process.
Prepare for the first patient question: “Does insurance cover it?” This is often the first question patients ask, so practices should have an approved response ready, being careful to note that coverage can vary and avoiding overpromising reimbursement. Understanding on- and off-indication criteria is essential to this process, and coverage varies based state-to-state.
Clarify the practice payment process upfront. At CEI, the team explains cost, and necessary documentation to include informed consent and appropriate insurance financial waivers (such as Advanced Beneficiary Notices, where necessary). This type of practice-specific process should be aligned with billing, compliance and revenue cycle teams, and be adjusted based on evolving payor trends.
Create a follow-up pathway for patients. A direct number, follow-up appointment or clear point of contact can help patients revisit coverage questions as needed. At CEI, patients will typically be scheduled with their referring provider six to eight weeks after the conclusion of the first round of PBM to reassess vision, contrast, OCT and autofluorescence imaging.
Track billing-relevant details consistently. A spreadsheet that includes summary of patient history of dry AMD, whether on- or off-indication, diagnosis date, disease progression (dates), prior treatment dates, treatment failure dates, and decision for Valeda PBM treatment.
Patient selection criteria for Valeda PBM
Successful implementation depends not only on workflow, but also on identifying appropriate patients and setting expectations early. Early experience with Valeda PBM highlights the importance of thoughtful patient selection and clear communication.
“As soon as we knew Valeda was coming, I started tracking patients with early and intermediate-stage dry AMD during routine visits so we could begin having longitudinal conversations over time,” Dr. Foster explained. “That gave patients and families an opportunity to learn about the therapy gradually and ask thoughtful questions along the way.”
CEI’s patient selection and expectation-setting checklist
Practices may want to consider the following factors when identifying potential Valeda PBM patients and preparing them for treatment:
Identify patients with dry AMD based on physician assessment. During routine visits, physicians can begin tracking patients who may be appropriate for future Valeda PBM conversations.
Start with patients with the most potential for success. Physicians may begin with patients who have meaningful opportunities for functional improvement, then expand as their experience with the technology and treatment workflow grows. Valeda PBM is indicated for dry AMD patients with moderate vision loss, between 20/32 and 20/70.5
Assess whether the patient can commit to the visit schedule. Because treatment requires repeated in-office visits, practices should discuss transportation, availability and scheduling barriers early.
Set expectations around the goal of treatment. It’s important for patients to understand that while Valeda PBM can be a meaningful treatment that can help maintain function or improve vision, no cure for dry AMD currently exists.
The bottom line: build the workflow before demand grows
Successful Valeda PBM implementation required more than adding appointment slots to the schedule. While CEI’s model is one of many effective approaches, other practices may benefit from aligning clinical and administrative teams early, mapping the patient journey, preparing billing and reimbursement conversations, and identifying qualifying dry AMD patients who understand the treatment commitment and goals.
As experience grows, many physicians see Valeda PBM not just as a new treatment option, but as a way to rethink how they approach AMD care.
“We’re still early in understanding the full potential of Valeda in real-world practice,” Dr. Foster noted. “But what’s already clear is that if practices create thoughtful workflows and a strong patient experience, Valeda PBM can become a very sustainable part of retina care.”
FAQs About Valeda PBM
1. How do retina practices implement Valeda PBM?
Retina practices can start by building cross-functional alignment, piloting the workflow, identifying where treatment fits into the clinic schedule, designating a patient educator or coordinator, and creating a consistent tracking process.
2. What is the step-by-step Valeda PBM workflow?
A practical workflow may include physician identification, patient handoff to an educator or coordinator, patient education, schedule review, confirmation that required clinical information is current, visit logistics and financial counseling, treatment scheduling, documentation, patient feedback collection and ongoing communication.
3. How should practices approach billing and reimbursement conversations for PBM?
Practices should decide who owns reimbursement conversations, prepare approved responses to coverage questions, avoid overpromising reimbursement, clarify the practice payment process upfront and create a clear follow-up pathway for patients.
4. Which patients may be appropriate for Valeda PBM?
Physicians can identify patients with dry AMD based on clinical assessment, functional goals, ability to commit to the visit schedule, and readiness to have a clear expectations-setting conversation.
5. What should patients expect during Valeda PBM treatment visits?
Patients should understand that one treatment course consists of 9 treatments over three to five consecutive weeks, three times a year.5,** Valeda PBM is noninvasive and does not require pupil dilation. Practices should also explain visit logistics, scheduling expectations and whom patients can contact with questions.
About Robert Foster, M.D.
Robert E. Foster, MD, is a vitreoretinal specialist at Cincinnati Eye Institute, where he sees patients at the Blue Ash office. He earned his undergraduate degree in Biology from Michigan State University, graduating from the Honors College and being named one of the university’s Top 25 Graduating Seniors. He received his medical degree from the University of Michigan Medical School in 1988, completed his internship at Cleveland Clinic Foundation, where he was named Intern of the Year, and served as Chief Resident during his ophthalmology residency at Cleveland Clinic. He then completed retina subspecialty training at Bascom Palmer Eye Institute.
Before joining CEI in 1997, Dr. Foster developed a referral practice at Cleveland Clinic Foundation and lectured nationally and internationally. He has co-authored more than 70 peer-reviewed publications and remains active in clinical research. His clinical expertise includes diseases of the retina, macula, and vitreous, with a focus on diabetic retinopathy, macular degeneration, and retinal vascular disease.
About Miguel Busquets, M.D., F.A.C.S.
Dr. Miguel Busquets, MD, FACS, FASRS is a vitreoretinal surgeon, researcher, and educator with Cincinnati Eye Institute. Dr. Busquets is a Magna Cum Laude graduate of Harvard University and Duke University School of Medicine, where he graduated with high honors. He completed his ophthalmology residency and vitreoretinal surgical training at Washington University School of Medicine and the Barnes Retina Institute, where he received the Rosenbaum Research Award for best ophthalmological research. Currently, he is actively involved in research in the areas of surgical technology and drug development for macular degeneration, diabetic retinopathy, and retinal vascular disease, as well as artificial intelligence-based imaging, surgical planning and guidance, and remote monitoring for retinal disease. He is a national expert in retinal telehealth and is the author of numerous publications in this area. Besides delivering lectures worldwide on his research and retinal technologies, Dr. Busquets is certified by the American Board of Ophthalmology, a Fellow of the American Academy of Ophthalmology and the American College of Surgeons and is a member of the American Society of Retina Specialists, the Association for Research in Vision and Ophthalmology, the Vit Buckle Society, and The Retina Society. He has been a reviewer for the Journal of Vitreoretinal Diseases, Digital Health and the journal Retina, and a guest editor for the journal Medicina. He is the recipient of the prestigious American Society of Retina Specialists Honor Award. Dr. Busquets sees patients and performs surgery for all vitreous, retina, and macular conditions.
Important Product Information
Indications for Use
The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (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 central-involving geographic atrophy
After about two years, the Valeda Light Delivery System treatment provides improved mean visual acuity of approximately one line of visual acuity (ETDRS) compared to those not receiving the treatment.
Contraindications for Use
As a precaution, patients have not been tested and should not be treated with Valeda if they have any known photosensitivity to yellow light, red light, or near-infrared radiation (NIR), or if they have a history of light-activated central nervous system disorders (e.g., epilepsy, migraine). In addition, patients should not receive treatment within 30 days of using photosensitizing agents (e.g., topicals, injectables) that are affected by 590, 660, and/or 850 nm light before consulting with their physician.
Precautions
It is possible that treatment benefit may not persist significantly after treatment is stopped. The clinical study provided no significant data concerning the safety and effectiveness of the device should treatments be applied more frequently than described in this manual, or if more than 54 total treatments are delivered per eye.
* The Valeda Light Delivery System is intended to provide improved visual acuity in patients with best-corrected visual acuity of 20/32 through 20/70 and who have dry age-related macular degeneration (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
**For 2 years.
References
1. Markowitz SN, Devenyi RG, Munk MR, et al. A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION. Retina. 2020;40(8):1471-1482. doi:10.1097/IAE.0000000000002632
2. Fernandes AR, Zielińska A, Sanchez-Lopez E, et al. Exudative versus Nonexudative Age-Related Macular Degeneration: Physiopathology and Treatment Options. Int J Mol Sci. 2022;23(5):2592. Published 2022 Feb 26.
3. Evans J. Antioxidant supplements to prevent or slow down the progression of AMD: a systematic review and meta-analysis. Eye (Lond). 2008;22(6):751-760.
4. Valeda PBM Federal Drug Administration Instructions for Use.
5. Valeda PBM U.S. User Manual.
6. 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.
7. Richwine C. Progress and Persistent Disparities in Patient Access to Electronic Health Information. JAMA Health Forum. 2023;4(11):e233883-e233883. doi:https://doi.org/10.1001/jamahealthforum.2023.3883
8. Boyer, D, Do D, Xavier S, et al. A double-masked, randomized, sham-controlled, parallel group, multi-center study to assess the safety and efficacy of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) (LIGHTSITE III). Clinical Study Report CSP005.
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