The American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel has approved a new add-on Category III CPT code—exclusively intended for attachment and insertion of intraocular lens (IOL) prosthesis-mounted drug-eluting implants—in conjunction with established Category I cataract surgery procedure codes.
This approval, according to SpyGlass Pharma, Inc., was based on the biopharma company’s application for its investigational Bimatoprost Drug Pad-IOL (BIM-IOL) System.
That’s a lot to unpack … where to start?
First up: A rundown on this BIM-IOL System.
What it is: As SpyGlass Pharma’s lead investigational candidate, the system performs IOL implantation during cataract surgery.
Its purpose: To consistently (via sustained release) deliver multiple years—3 years, ideally—of bimatoprost for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
- See here for details on the design and click here for a visual of it in action.
- Check out this reasoning for why the platform utilizes bimatoprost, an FDA-approved prostaglandin analog.
And how has the system performed in clinical evaluations?
Our latest coverage on the BIM-IOL System was in November 2025, in which SpyGlass reported positive findings from two clinical trials:
- A first-in-human (FIH) study: 36-month follow-up
- See here for the data.
- Phase 1/2 trial: 3-month interim safety and efficacy data
- See here for the data.
Alrighty, now to this CPT code news.
We’ll take a look at Category III CPT codes.
What they are: Released biannually, these are temporary tracking codes for new and emerging technologies, procedures, and services still under evaluation.
Their purpose: To collect data in the FDA approval process or to substantiate widespread usage of new and emerging technology to justify the establishment of a permanent Category I CPT code.
- Take note: Category I CPT codes are reserved for the billing purposes of established and widely used standard medical devices and procedures.
Regarding Category III codes—what criteria must be met?
Procedures or services in this category must be currently (or recently) performed in humans as well as meet one or more of the additional criteria:
- Support from at least one CPT or HCPAC Advisor representing practitioners who would use the procedure or service
- Peer-reviewed literature supporting the actual or potential clinical efficacy of the specific procedure
- A minimum of one Institutional Review Board (IRB)-approved protocol of a study on the procedure/service being performed or:
- A description of a current and ongoing U.S. trial outlining its efficacy
- Other evidence of evolving clinical utilization
Gotcha. And how does an add-on CPT code factor in?
Generally speaking: CPT add-on codes are supplementary procedure codes (marked with a + symbol) that describe additional, related services performed by the same provider during the same session as a primary procedure.
… and in the case of the BIM-IOL System?
As it relates to SpyGlass Pharma’s news:
- The add-on CPT code: A Category III CPT code for attachment and insertion of IOL prosthesis-mounted, drug-eluting implant.
- The established CPT codes to a supplement to: Category I cataract surgery procedure codes.
As for the specific add-on CPT code: That would be +X659T.
Noted. So what will this add-on CPT code mean for reimbursement?
The issuance of an add-on CPT code not only translates to additional reimbursements, but is also considered “an important milestone” for cataract surgeons choosing to use the BIM-IOL.
- “When cataract and glaucoma surgeons have a clear, thoughtful, evidence-based pathway to treat glaucoma during their cataract surgeries, they can more readily adopt technologies like the BIM-IOL System,” stated Ike Ahmed, MD, professor and director of the Alan S. Crandall Center for Glaucoma Innovation, John A. Moran Eye Center, University of Utah.
This clear pathway also means further patient access (often a significant barrier for new technologies) to the system.
Nice! And when does the add-on CPT code go into effect?
While the release date for the new add-on CPT code is July 1, 2026, it won’t go into effect until Jan. 1, 2027.
Also important to note: Surgeons will not be able use this code for billing purposes until after the BIM-IOL System receives FDA clearance..
In other words: The add-on CPT code’s use is dependent on the system’s regulatory clearance and subsequent U.S. commercial launch.
Understood. So what’s the latest on the system’s regulatory pathway?
Currently: The BIM-IOL System is under evaluation in two identical registrational phase 3 clinical trials for IOP reduction among patients with OAG or OHT and a concomitant cataract.
- See here for details on the study designs, participants, and measurable outcomes.
The plan: For patient enrollment in both trials to conclude in 2027.
The goal: A streamlined new drug application (NDA) review pathway toward eventual regulatory approval and commercial launch.
And the big-picture significance?
This novel technology stands to become the first-and-only product candidate addressing glaucoma and cataracts at the same time in a single intervention.
*Disclaimer: The information provided in this article does not and is not intended to constitute legal advice; instead, all information, content, materials available herein are for general information purposes only.