The microinvasive glaucoma surgical (MIGS) market was born on June 25, 2012, with the FDA approval of the first-generation iStent (Glaukos). As the founding member of the MIGS market, Glaukos proceeded to commercialize the iStent with a Category III “Emerging Technology” current procedural terminology (CPT) code (CPT code 0191T). Reimbursement changes that were proposed and then revised by the Centers for Medicare & Medicaid Services (CMS) in 2021 have caused concern among glaucoma surgeons about the future of MIGS. However, it is helpful to look back at the history of MIGS reimbursement to understand the reimbursement landscape going into 2022. Trabecular meshwork (TM) stents now have 2 Category I CPT codes, one with complex cataract surgery (CPT code 66989) and one with noncomplex (CPT code 66991) cataract surgery. This article will focus on TM stent with noncomplex cataract surgery because that is the most commonly performed of the 2 procedures.

Coding With Introduction of Trabecular Meshwork Stents

Category III codes are placed in an ambulatory payment classification (APC) and assigned a facility fee amount by CMS, but not a professional fee amount, because relative value units have yet to be assigned. Additionally, these codes are automatically assigned noncoverage decisions by payers. This requires the code sponsor (Glaukos, in this case) to negotiate coverage and professional fee amounts with Medicare contractors and private payers across the country. Glaukos’s market access team did a tremendous service for the ophthalmic community by successfully advocating for robust professional fees and broad coverage across payers. In addition, CPT code 0191T received device-intensive designation effective January 1, 2017, increasing its ambulatory surgical center (ASC) facility fee by more than 40% relative to other procedures in the same APC.

This foundation allowed TM stents to rapidly gain adoption. As the code’s sponsor, Glaukos extended CPT code 0191T multiple times to preserve its advantageous reimbursement coverage. The widespread use of TM stents ultimately prompted CMS in 2018 to require conversion of the code from Category III to Category I on January 1, 2022. Trabecular meshwork stents are FDA approved only for use in combination with cataract surgery, and this led to the creation of the 2 Category I CPT codes now used: one for TM stent implantation with complex cataract surgery (CPT code 66989) and one for TM stent implantation with noncomplex cataract surgery (CPT code 66991), which is the most commonly performed.

These coding changes led to the American Medical Association’s Relative Value Scale Update Committee (RUC) 2020 survey and recommendation. In the proposed rules that CMS released in July 2021, CMS rejected the RUC recommendation and instead assigned a $34.26 incremental payment (based on the National Fee Schedule) for a TM stent placement over standalone cataract surgery. This spurred an uproar from the ophthalmic community that included 1,300 submitted comments to CMS. CMS responded by increasing the incremental payment for TM stent placement to $134.73 in their final rules for 2022. Although this increase represented a victory of sorts, stent placement became the MIGS procedure with the lowest reimbursement following this ruling. This is particularly disappointing because of recent reported benefits of TM stents compared to cataract surgery alone for patients with glaucoma. Along those lines, with procedures that combine canaloplasty and goniotomy, the patient is likely getting “better value” for their health care dollar, given that only 1 code is typically billed. In addition, more than 200 peer-reviewed publications demonstrate the efficacy and safety of iStent technologies in glaucoma patients around the world. There are quality stent data, but reimbursement does not respect the patient benefit, and this should be remedied.

Current Reimbursement in the Real World

What do these changes mean for the busy surgeon performing a MIGS procedure with cataract surgery? For many surgeons, this will reframe the decision between using a TM stent and performing a nonimplant procedure, such as goniotomy or canaloplasty. It is also possible that combination procedures will continue to increase in popularity. Beginning January 1, 2022, surgeons performing cataract surgery with goniotomy or canaloplasty will earn a professional fee based on the CMS National Fee Schedule of approximately $1,078.17 and $1,003.25, respectively, vs $663.57 for placing a TM stent during a cataract procedure (Table 1). This approximately $415 additional reimbursement, in the case of goniotomy, translates to approximately $50,000 in annual practice receivables for a surgeon performing 10 MIGS–cataract procedures each month. Similar economics are provided when combining procedures such as a TM stent with canaloplasty or goniotomy, in addition to providing the patient the benefit of treating multiple mechanisms of action. Because most, if not all, surgeons have faced aggressive reimbursement cuts in areas of diagnostics, office visits, and other procedures, it is likely that surgeons will need to optimize revenues to maintain current practice operations.

Surgeons who own their ASC may be able to partially offset this difference through the facility fee for each procedure. However, the relative costs of each device must also be considered in this assessment. Although cataract surgery with TM stent placement is associated with a $3,245.55 National Fee Schedule facility fee, which is $795.19 greater than either goniotomy or canaloplasty, the cost of TM stents vs the devices used in nonimplant MIGS procedures often exceed this amount. For example, investment analysts estimate that the KDB Glide (New World Medical), which is designed for excisional goniotomy, has an average selling price of $450 compared to approximately $1,450 for a TM stent (prices may vary and are subject to negotiation). For a surgeon performing cataract surgery in an ASC in which they have ownership interest, this translates to an additional combined (facility and professional fee) revenue of $619.41 from performing excisional goniotomy with the KDB Glide vs implanting a TM stent, such as the iStent inject W (Glaukos) or Hydrus (Ivantis) (Table 2). It should also be noted that for appropriate patients with more significant medication usage and glaucoma, currently ASC reimbursement will allow combined stent plus procedure payments.

The Future of MIGS Reimbursement

The next revaluation of MIGS professional fees is expected to be effective on January 1, 2026. This leads me to believe that there will be a shift in care over the next 4 years as these nonimplant procedures, specifically goniotomy and canaloplasty or combined procedures, garner significant peer-reviewed literature that substantiates their clinical safety and efficacy.

As with virtually all reimbursement changes, CMS’s approach to valuing TM stents is disappointing. The only silver lining is that we have credible alternatives to offer our patients and a stable reimbursement environment for the next 4 years.