New Medicare coding and payment determinations for Balance Ophthalmics’ FSYX Ocular Pressure Adjusting Pump take effect October 1, establishing separate HCPCS Level II codes for the pump and its goggles.

The Centers for Medicare and Medicaid Services (CMS) established E2403, “External ocular negative pressure pump, electric,” for FSYX and classified the prescription device as durable medical equipment. CMS calculated an approximate 2026 capped-rental fee of $1,352.58 per month for the first 3 months and $1,014.44 for months 4 through 13, for a potential total payment of $14,202.09 after 13 months of continuous use.

CMS also established A6614 for supplies and accessories used with an external ocular negative pressure pump, with an approximate 2026 fee-schedule amount of $167.99. The agency initially assigned A6610 but changed the code to A6614 in August because A6610 was already in use.

FSYX is indicated to reduce intraocular pressure (IOP) during sleep in adults with open-angle glaucoma and IOP of 21 mmHg or less who are using or have undergone another IOP-lowering treatment.

The original system received FDA De Novo authorization in June 2024; a subsequent version received 510(k) clearance in April 2026.

The coding and payment determinations do not themselves establish Medicare coverage; coverage remains subject to applicable Medicare requirements and determinations.