Micro-Invasive Glaucoma Surgery (MIGS)

Jurisdiction: J6 MAC Part B. States: Illinois, Minnesota, Wisconsin. Type: Active LCD

Indications of Coverage The following are considered reasonable and necessary and covered: One trabecular aqueous stent device per eye which is approved for the treatment of adults with mild or moderate open-angle glaucoma (OAG) and a cataract when the individual is currently being treated with an ocular hypotensive medication and the procedure is being performed in conjunction with cataract surgery. One subconjunctival space stent or trabecular aqueous stent device is approved for use as a standalone procedure device per eye for the management of refractory glaucoma, defined as prior failure of a filtering/cilioablative procedure OR uncontrolled intraocular pressure (IOP) defined a progressive damage or mean diurnal medicated IOP ≥20 mmHg on maximally tolerated medical therapy (i.e., ≥4 classes of topical IOP-lowering medications, or fewer in the case of tolerability or efficacy issues). Phacoemulsification/intraocular lens placement can be performed with a single MIGS procedure. Limitations Minimally invasive glaucoma surgery (MIGS) is not considered a first line treatment for mild-moderate glaucoma. A combination of a surgical MIGs procedure and an aqueous shunt cannot be performed at the same time of service in the same eye. Phacoemulsification/ intraocular lens placement performed with a combination of a MIGS procedure, (e.g., cataract + stent + canaloplasty or goniotomy) at the same time of service in the same eye is non-covered. A Contractor Advisory Committee Meeting on Micro-Invasive Glaucoma Surgery was held on 1/5/2023 hosted by Palmetto, CGS, NGS, Noridian, and WPS. Transcripts are available at: Jurisdiction J Part A - Multi-Jurisdictional Micro-Invasive Glaucoma Surgery Contractor Advisory Committee Meeting: January 5, 2023 (palmettogba.com) . The input from subject matter experts will be referenced throughout this policy. Provider Qualifications The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers. XEN45 insertion must be performed by an ophthalmologist with experience with trabeculectomy and bleb management. Patient safety and quality of care mandate that healthcare professionals who perform minimally invasive glaucoma surgeries are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings. 1 Definitions Canaloplasty- Cannulation of Schlemm’s canal with a catheter or stent with either an internal or external approach for at least three clock hours with an injection of viscoelastic while removing the stent to dilate the canal or via three or more punctures of the trabecular meshwork spanning at least three clock hours (90 degrees) to dilate Schlemm’s canal. 2 Goniotomy- Incision and/or excision with blade or surgical instrument for at least 3 clock hours of trabecular meshwork to create an opening into Schlemm's canal from the anterior chamber, via an internal approach . 3 High quality literature - Further research is very unlikely to change our confidence in the estimate of effect. 4 Maximum tolerated medical therapy- is attained as soon as the patient is successfully using the greatest number of topical glaucoma medication classes he or she can tolerate and that add additional IOP reduction. 5 Minimally Invasive glaucoma surgery (MIGS)- a group of surgical procedures that are performed using an ab interno approach and designed to reduce trauma to ocular tissues. 6 Moderate quality literature- F urther research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. 4 Primary open-angle glaucoma (POAG) - potentially blinding condition caused by chronic, progressive optic neuropathy in adults in which there is acquired atrophy of the optic nerve with loss of retinal ganglion cells and their axons. 6 Refractory Glaucoma - when the intraocular pressure remains above target values selected to slow or halt the disease, despite the use of multiple classes of medications, or fewer medications when tolerability or effectiveness limits the use of other drug classes or failed surgical therapy. 5