The iStent® Trabecular Micro-Bypass (Glaukos Corp., Laguna Hills, CA) is a minimally invasive glaucoma surgery device that is designed to create a permanent pathway for aqueous to pass directly into Schlemm's canal. The iStent (Models GTS100R and GTS100L) is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.

The vast majority of current glaucoma surgeries including those that insert or implant synthetic devices typically require medical record documentation that the patient has failed maximum medical therapy. The iStent is indicated for use in conjunction with cataract surgery in patients who probably, in all likelihood, have not failed maximum medical therapy for their mild to moderate open-angle glaucoma. It is expected, as the FDA indication states, that all potential candidates for the iStent will be on concurrent ocular hypotensive medication therapy leading up to their need for cataract surgery.

Currently, there is no local coverage determination (LCD) for the implantation of the iStent which requires the category III CPT code 0191T in conjunction with a cataract surgery code (e.g., 66984). First Coast Service Options, Inc., (First Coast) the Medicare Administrative Contractor for jurisdiction 9 (MAC J9), which includes Florida, Puerto Rico and the U.S. Virgin Islands, is currently reviewing 0191T claims and the medical record documentation on a case by case basis. Category III codes are temporary codes for emerging technology, services and procedures, and allow for tracking and data collection. They also allow for appropriate coverage and reimbursement as determined by the MACs and other insurance payers.

For proper coverage consideration from First Coast , or any Medicare entity, the medical record should establish medical necessity and documentation should include a statement that assures a "potential chart reviewer" that 1) you, the surgeon, have a reasonable expectation that the insertion of the iStent will benefit the patient's current glaucoma therapy in an attempt to prevent the need for maximum medical therapy, 2) the iStent is being inserted because there is already a medically necessary reason for removing a cataract in that eye and 3) the patient is currently on ocular hypotensive medications to control their mild to moderate open-angle glaucoma.

Although this documentation does not guarantee that your claim will not be denied, it will certainly provide a potential reviewer with enough information to justify the medical necessity of the iStent implantation procedure.

Providers should follow the normal appeals process for any denial because if the provider were to re-submit a denied claim and get another denial (for any reason), the number of days they would have to appeal is counted from the first claim that denied. Therefore, it is very important for providers to follow the timeliness associated with the appeals process, which is 120 days from the date of the first denial.