Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Primary Open Angle Glaucoma and Cataract.
Treatment:  Transluminal Dilation of Aqueous Outflow Canal without Retention of Device or Stent (Canaloplasty) (66174/79/LT).

The insurer denied Transluminal Dilation of Aqueous Outflow Canal without Retention of Device or Stent (Canaloplasty) (66174/79/LT).  The denial is overturned.

The patient is an adult male with history of primary open angle glaucoma and cataract, for whom coverage of surgery (Omni canaloplasty) performed at the time of cataract surgery 6 months ago is the subject of review. Reportedly, the same procedure performed 7 months ago had been approved. Coverage was denied per policy as unproven and not medically necessary. It is reported that the patient has been treated with selective laser trabeculoplasty with intraocular pressures above target and visual field testing showing superior arcuate defects for both eyes (OU).

The proposed treatment was medically necessary.

According to Dickerson et al., combined trabeculotomy and viscodilation ab interno was a novel approach with a new purpose-designed device (OMNI Surgical System) which became available to surgeons in early 2018. The OMNI Surgical System (Sight Sciences) provides the ability to perform a circumferential viscodilation and trabeculotomy using the same device.

Brown et al. reported promising preliminary results for a series of 54 eyes (41 where the OMNI was used with cataract surgery and 13 in pseudophakic patients). In combined cases and the majority of standalone (8/13) the treatment consisted of 180-degree viscodilation and trabeculotomy. Five eyes in the standalone group with more advanced disease were treated 360-degrees. Mean intraocular pressure (IOP) reductions were 5.8 millimeters of mercury (mmHg) in the combined cases and 10.0 millimeters of mercury (mmHg) for the standalone group. More recently, Vold et al. found that sequential combination of canaloplasty followed by trabeculotomy performed as stand-alone procedures using the OMNI system in pseudophakic patients with open-angle glaucoma provides effective intraocular pressure reduction or sustained intraocular pressure control and meaningful medication reduction for up to 12 months postoperatively. Theirs was a retrospective, multicenter, single-arm study conducted at ten multi-subspecialty ophthalmology practices and surgery centers located in seven states. 

In a retrospective, observational study of 80 eyes from 73 patients with mild to moderate open angle glaucoma, Toneatto et al. found that viscodilation of Schlem's canal using OMNI viscosurgical systems is safe and relatively effective in reducing intraocular pressure in adult patients with open angle glaucoma (OAG).

Therefore, as there is support in the peer reviewed medical literature for this approach, and as the patient was undergoing cataract surgery where OMNI canaloplasty may reduce or eliminate the need for medical therapy in this patient with glaucoma who has failed selective laser trabeculoplasty, the requested services were medically necessary. The service was clinically appropriate in terms of type, frequency, extent, site, and duration, and considered effective for the patient's illness, injury, or disease; the service was required for the direct care and treatment or management of that condition; the condition would be adversely affected if the services were not provided; the service was provided in accordance with generally accepted standards of medical practice; and the service was not primarily for the convenience of the patient, the patient's family, or the Provider.