 | Effective February 16, 2010, the Company has updated its coverage and reimbursement position for Aqueous Shunt Devices for Glaucoma.
- Aqueous Shunt Devices - External Approach
For commercial and Medicare Advantage members, US Food and Drug Administration (FDA)-approved aqueous shunt devices that are inserted by an external approach (CPT code 0192T) are considered medically necessary and, therefore, covered for the reduction of elevated intraocular pressure (IOP) in individuals diagnosed with primary open-angle glaucoma when medical and conventional surgical treatments (eg, trabeculectomy) have failed to adequately control IOP. Coverage for Medicare Advantage members is retroactive to January 1, 2009.
- Aqueous Shunt Devices - Internal Approach
For commercial members, aqueous shunt devices that are inserted by an internal approach (CPT code 0191T) are considered experimental/investigational and, therefore, not covered because the safety and/or efficacy of this technology cannot be established by a review of the available published peer-reviewed literature. In addition, there are no internal approach devices that have received approval by the FDA. However, the FDA has classified the iStent under an investigational device exemption (IDE) as a Category B device; this device is eligible for reimbursement consideration for Medicare Advantage members.
To report these, use the following Current Procedural Terminology (CPT) codes:
- 0191T: Insertion of anterior segment aqueous drainage device, without extraocular reservoir; internal approach.
- 0192T: Insertion of anterior segment aqueous drainage device, without extraocular reservoir; external approach.
About Aqueous Shunts and Devices for Glaucoma
Glaucoma is a group of diseases affecting the optic nerve. There are many types of glaucoma, but the most common types are primary open-angle glaucoma and acute angle-closure glaucoma. Open-angle glaucoma develops gradually and is usually without symptoms. Acute angle-closure glaucoma is a medical emergency that, if left untreated, will lead to blindness within days.
In the primary outflow pathway of the eye, aqueous humor (the clear liquid that contains nutrients) passes through the trabecular meshwork and enters Schlemm’s canal, where it is channeled into the aqueous veins. When there are increases in the pressures surrounding the trabecular meshwork and/or the inner wall of Schlemm’s canal, the inflow/outflow balance is disrupted. The resulting effect is an increased intraocular pressure (IOP) and risk for glaucoma. Without medical/surgical intervention, prolonged increases in IOP may result in neuropathy of the optic nerve.
Medical intervention to reduce IOP is usually attempted first. If unsuccessful, surgical intervention is warranted. Trabeculectomy is the most established surgical procedure for treating glaucoma because it allows the aqueous humor to directly enter the subconjunctival space. However, the reservoir created by this procedure may result in filtering blebs on the eye and other complications such as, but not limited to: leaks, endophthalmitis, and long-term failure.
Aqueous shunts are implantable devices that are intended to reduce IOP in the anterior chamber of the eye in individuals with neovascular glaucoma or with glaucoma that has not responded to medical and conventional surgical treatments. There are several devices that have been approved by the US Food and Drug Administration (FDA) to facilitate the inflow/outflow balance of aqueous humor in the eye. Examples of devices that are FDA-approved for insertion by an external approach are Ex-PRESS™ Mini Glaucoma Shunt (Optonol Ltd., Neve Ilan, Israel), Baerveldt glaucoma drainage devices (Advanced Medical Optics, Santa Ana, CA), Krupin eye valves (Eagle Vision, Inc., Memphis, TN), Molteno implants (Molteno Ophthalmic Ltd., Dunedin, New Zealand), and Ahmed Glaucoma Valve (New World Medical, Inc., Rancho Cucamonga, CA).
Currently, there are no FDA-approved devices that are inserted by an internal approach to treat glaucoma. The iStent (Glaukos Corp., Laguna Hills, CA), an internal approach device, has been classified by the FDA under an investigational device exemption (IDE) as a Category B device.
If you have any questions, contact your Network Coordinator.
Policy impacted:
12.01.01g Experimental/Investigational Services
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