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DESCRIPTIONGlaucoma surgery is intended to reduce intraocular pressure (IOP) when the target IOP cannot be reached with medications. Due to complications with established surgical approaches such as trabeculectomy, a variety of devices, including aqueous shunts and transluminal dilation procedures, are being evaluated as alternative surgical treatments for patients with glaucoma.
Surgical procedures for glaucoma aim to reduce intraocular pressure (IOP) resulting from impaired aqueous humor drainage in the trabecular meshwork and/or Schlemm’s canal. In the primary (conventional) outflow pathway from the eye, aqueous humor passes through the trabecular meshwork, enters a space lined with endothelial cells (Schlemm’s canal) and then drains into the aqueous veins. Increases in resistance in the trabecular meshwork and/or the inner wall of Schlemm’s canal can disrupt the balance of aqueous humor inflow and outflow, resulting in an increase in IOP and glaucoma risk.
Surgical intervention may be indicated in patients with glaucoma when the target IOP can not be reached pharmacologically. Trabeculectomy (guarded filtration surgery) is the most established surgical procedure for glaucoma, allowing aqueous humor to directly enter the subconjunctival space. This procedure creates a subconjunctival reservoir which can effectively reduce IOP, but commonly results in filtering “blebs” on the eye, and is associated with numerous complications (e.g., leaks or bleb-related endophthalmitis) and long-term failure. Other surgical procedures (not addressed in this policy) include trabecular laser ablation, deep sclerectomy, which removes the outer wall of Schlemm’s canal and excises deep sclera and peripheral cornea, and viscocanalostomy, which unroofs and dilates Schlemm’s canal without penetrating the trabecular meshwork or anterior chamber.
The Trabectome™ is a recently developed electrocautery device with irrigation and aspiration designed to selectively remove trabecular meshwork and Schlemm’s canal inner wall without external access or creation of a subconjunctival bleb. IOP with this ab interno procedure is typically higher than the pressure achieved with standard filtering trabeculectomy. Canaloplasty involves dilation and tension of Schlemm’s canal with a suture loop between the inner wall of the canal and the trabecular meshwork. Canaloplasty utilizes the iTrack™ illuminated microcatheter (iScience Interventional) to access and dilate the entire length of Schlemm’s canal and to pass the suture loop through the canal.
Aqueous shunts may also be placed between the anterior chamber (or vitreous chamber) and Schlemm’s canal to facilitate drainage of aqueous humor. Established shunts include the Ahmed (New World Medical), Baerveldt (Advanced Medical Optics), Krupin (Eagle Vision) and Molteno (Molteno Ophthalmic). These devices differ depending on explant surface areas, shape, plate thickness, the presence or absence of a valve, and details of surgical installation. Generally, the risk of hypotony is reduced with aqueous shunts in comparison with trabeculectomy, but IOP outcomes are higher than after standard guarded filtration surgery. Complications of anterior chamber shunts include corneal endothelial failure and erosion of the overlying conjunctiva. The risk of postoperative infection is less than after trabeculectomy, and failure rates are similar, with about 10% of devices failing each year. The primary indication for aqueous shunts is when prior medical or surgical therapy has failed, although some ophthalmologists have advocated their use as a primary surgical intervention, particularly for selected conditions such as congenital glaucoma, trauma, chemical burn, or pemphigoid.
Other aqueous shunts are being developed as minimally penetrating methods to drain aqueous humor from the anterior chamber into an ocular reservoir. These include the iStent (Glaukos), which is inserted into the end of Schlemm’s canal by either an internal (through the cornea and anterior chamber) or external approach (through the subconjunctiva); the EyePass Bi-Directional Glaucoma Implant (GMP Companies), which is a Y-shaped shunt in which the 2 arms are placed ab externo into both lumina of Schlemm’s canal; and the Solx DeepLight Gold Micro-Shunt (OccuLogix), which shunts aqueous humor between the anterior chamber and the suprachoroidal space.
Since aqueous humor outflow is pressure dependent, the pressure in the reservoir and venous system are critical for reaching the target IOP. Therefore, some devices may be unable to reduce IOP below the pressure of the distal outflow system used, e.g., below 15 mmHg, and are not indicated for patients for whom very low IOP is desired (e.g., those with advanced glaucoma). It has been proposed that shunts may be useful to lower IOP in patients with early stage glaucoma to reduce the burden of medications and problems with compliance. One area of investigation is for patients with glaucoma who require cataract surgery. An advantage of ab interno shunts is that they may be inserted into the same incision and at the same time as cataract surgery. In addition, most devices do not preclude subsequent trabeculectomy if needed. It may also be possible to insert more than one shunt to achieve the desired IOP. Therefore, health outcomes of interest are the IOP achieved, reduction in medications, ability to convert to trabeculectomy, complications, and durability of the device.
The Trabectome™ was cleared by the U.S. Food and Drug Administration (FDA) in 2006 for “use with compatible electrosurgical instruments in low power microsurgical applications for the removal, destruction and coagulation of tissue.” The iTrack (iScience Interventional) received 510(k) marketing clearance from the FDA in 2004 as a surgical ophthalmic microcannula that is indicated for the general purpose of “fluid infusion and aspiration, as well as illumination, during surgery.”
The first generation Ahmed (New World Medical), Baerveldt (Advanced Medical Optics), Krupin (Eagle Vision) and Molteno (Molteno Ophthalmic) aqueous shunts received marketing clearance from the FDA between 1989 and 1993; modified Ahmed and Molteno devices were most recently cleared in 2006. Their indication for use is “in patients with intractable glaucoma to reduce intraocular pressure where medical and conventional surgical treatments have failed.” The AquaFlow™ Collagen Glaucoma Drainage Device received premarket approval from the FDA in 2001 for the maintenance of sub-scleral space following non-penetrating deep sclerectomy. The Ex-PRESS™ Mini Glaucoma Shunt received 510(k) marketing clearance in 2002. The Ex-PRESS shunt is placed under a partial thickness scleral flap and transports aqueous fluid from the anterior chamber of the eye into a conjunctival filtering bleb.
The iStent, EyePass and Solx gold shunt are currently in FDA trials (the iStent trial’s FDA investigational device exemption [IDE] designates the iStent as a category B device). The Micro-Shunt and Solx gold shunt have received regulatory approval in Europe. These are not FDA-approved/cleared for use in the U.S. at this time.
Related policies include Ophthalmologic Techniques of Evaluating Glaucoma and Transciliary Fistulization for the Treatment of Glaucoma.
POLICYInsertion of aqueous shunts approved by the U.S. Food and Drug Administration (FDA) may be considered medically necessary as a method to reduce intraocular pressure in patients with glaucoma where medical therapy has failed to adequately control intraocular pressure.
Use of an aqueous shunt for all other conditions, including in patients with glaucoma when intraocular pressure is adequately controlled by medications, is considered investigational.
Use of a micro-stent is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/24/2008: Policy added
11/20/2008: Approved by Medical Policy Advisory Committee (MPAC)
05/13/2010: Policy title changed from "Emerging Surgical Treatments for Glaucoma" to "Aqueous Shunts and Devices for Glaucoma." Policy description updated regarding treatment approaches and FDA status of devices. Policy statement revised to indicate that insertion of aqueous shunts approved by the U.S. Food and Drug Administration (FDA) may be considered medically necessary as a method to reduce intraocular pressure in patients with glaucoma where medical therapy has failed to adequately control intraocular pressure. Moved HCPCS codes 0191T and 0192T from non-covered to covered. All other conditions and canaloplasty remain investigational. FEP verbiage added to the Policy Exceptions section.
03/07/2011: Added new CPT codes 0253T and 66175 to the Code Reference section.
08/11/2011: Policy statement revised to indicate that canaloplasty may be considered medically necessary under certain conditions. Moved CPT code 66175 from non-covered to covered.
01/09/2013: In the policy title, changed "Devices" to "Stents." Added the following investigational policy statement: Use of a micro-stent is considered investigational.
04/24/2013: Added ICD-9 codes 365.00-365.9 and 12.67 to the Code Reference section.
SOURCE(S)Blue Cross and Blue Shield Association Policy # 9.03.21
This may not be a comprehensive list of procedure codes applicable to this policy. The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.