CMS payment rates for the FSYX Ocular Pressure Adjusting Pump take effect October 1, 2026, clearing a reimbursement path for the noninvasive glaucoma device.
The Centers for Medicare & Medicaid Services (CMS) has finalized 2026 payment amounts for the FSYX Ocular Pressure Adjusting Pump (OPAP; Balance Ophthalmics), a
Under HCPCS Level II code E2403, the pump will be reimbursed as a capped rental of approximately $1,352.58 per month for the first 3 months and $1,014.44 per month for months 4 through 13, for a total capped payment of $14,202.09 per beneficiary over 13 months of continuous use, according to the company.¹ The companion goggles, assigned code A6610, received a final 2026 fee schedule amount of approximately $167.99 per unit.¹
“Establishing a Medicare payment pathway brings us an important step closer to getting this technology into the hands of open-angle glaucoma patients, particularly those who may need additional IOP reduction despite existing treatment,” Richard A. Lewis, MD, past president of the American Society of Cataract and Refractive Surgery and the American Glaucoma Society, said in the company’s statement.¹
KEY FACTS
The FSYX system’s original configuration received FDA marketing authorization through the De Novo classification pathway (DEN230055), establishing a new device category (product code QQJ) for non-powered, external negative-pressure applicators used to reduce IOP.2 Balance Ophthalmics states that a wireless-enabled next-generation version of the system received separate FDA 510(k) clearance earlier in 2026, though the company has not published the associated 510(k) number.¹ The newly finalized Medicare rates apply to the pump and goggles under existing durable medical equipment coding.¹
Nocturnal IOP elevation has been implicated in glaucomatous progression independent of daytime IOP control, with peak IOP typically occurring during sleep due to positional and physiologic changes in aqueous dynamics.3 Most existing pharmacologic and surgical treatments lower nighttime IOP less effectively than daytime IOP, leaving a recognized gap in disease management, particularly for patients with normal-tension glaucoma, in whom nocturnal pressure elevations may be especially consequential.3
The FSYX system pairs pressure-sensing goggles with a pump that applies gentle negative pressure to the periocular space during sleep, lowering IOP through a physical mechanism rather than pharmacologic or surgical means, according to the manufacturer.¹ The company cites pooled data from 12 clinical studies involving more than 600 eyes showing a 39% mean reduction in nighttime IOP with no device-related serious adverse events, though this pooled figure has not been published in a peer-reviewed format the company has cited.¹
The most substantive published evidence comes from the HERCULES study (NCT04236869), a prospective, multicenter, randomized, fellow-eye controlled trial in patients with normal-tension glaucoma in which one eye received overnight negative-pressure application while the fellow eye served as a control; the study assessed the proportion of eyes achieving at least a 20% reduction in daytime IOP as its primary end point, with nocturnal IOP reduction as a secondary end point.4 Long-term adherence and comparative effectiveness data against existing glaucoma therapies were not addressed in the release, and real-world uptake following the October 2026 payment implementation may help clarify practical adoption.¹
Ophthalmology Times reached out to Lewis for his feedback on patient selection, coverage nuances, and where FSYX fits within the broader glaucoma treatment paradigm.
Note: Transcript lightly edited for clarity and length.
Lewis: A finalized Medicare payment is a huge step for a start-up company. Patients covered under fee-for-service (FFS) Medicare will now have access, which is a positive step forward for glaucoma care. Some patients with secondary coverage may still face challenges under those plans that follow suit with FFS Medicare. The same may apply to commercial carriers. However, there are already a few plans paying for the device, while others await additional clinical information and education on where FSYX OPAP can be implemented within the glaucoma treatment regimen.
Lewis: Unlike a number of medications or surgical procedures that are effective only in specific types of glaucoma, such as open-versus closed-angle disease, FSYX offers a different mechanism for lowering IOP. For example, it can be very difficult to lower IOP in normal-tension glaucoma. Patients with pressures already in the low teens generally do not respond as robustly to many medications or surgeries, perhaps with the exception of a well performed trabeculectomy. FSYX provides a non-pharmacological, non-surgical intervention that works through a different mechanism to lower IOP to the desired level while the device is worn.
Lewis: While FSYX could be considered for patients whose IOP remains higher than desired, many patients in the early stages of disease respond well to existing treatments. Patients who are recalcitrant to therapy for a variety of reasons, or who need additional IOP lowering despite their current treatment regimen, could be excellent candidates for the FSYX OPAP device.
