Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules state that the Hydrus Microstent is indicated for use in conjunction with cataract surgery for the 
reduction of IOP in adult patients with mild to moderate POAG. In summary, this A/B Medicare 
Administrative Contractor (MAC) considers 1 iStent, iStent inject (device capable of delivering 2 
individual iStents per eye) medically reasonable and necessary for the treatment of adults with mild or 
moderate 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. In that setting these 
procedures offer a reduction in IOP, decreased dependence on glaucoma medications and an excellent safety 
profile. However, their role within the glaucoma treatment algorithm continues to be clarified and differs from 
the role of more invasive, external filtration glaucoma surgeries such as trabeculectomy or external aqueous 
drainage implants. Therefore, all other indications are considered not reasonable and necessary at this time. 
There is no additional payment for multiple stents (so-called dosing"), regardless of method, since a statistical 
benefit has not been demonstrated7, especially in conjunction with cataract surgery. 
 
The XEN45 device received 510K clearance based on having a similar mechanism (subconjunctival 
pathway) as gold standard filtration procedures (trabeculectomy and tube shunts), demonstrating substantial 
equivalence in the pivotal prospective study of patients with refractory glaucoma.9 Equivalency was further 
established by a relatively large retrospective cohort study comparing XEN45 with trabeculectomy, finding 
no detectable difference in risk of failure and safety profiles.8 In addition, the American Glaucoma Society 
(AGS), the New York State Ophthalmological Society (NYSOS), and numerous glaucoma experts wrote to 
support XEN45 as a minimally invasive method that, would improve the access of older patients with 
refractory glaucoma to surgical care with reduction in post-operative discomfort, shorter post-operative 
disability, equivalent efficacy and safety. 
 
This A/B MAC considers 1 XEN45 device per eye medically reasonable and necessary for the management 
of refractory glaucoma, defined (based on the pivotal trial criteria) as prior failure of filtering/cilioablative 
procedure and/or uncontrolled IOP (progressive damage and mean diurnal medicated IOP =20 mm Hg) on 
maximally tolerated medical therapy (i.e., =4 classes of topical IOP-lowering medications, or fewer in the case 
of tolerability or efficacy issues). XEN45 insertion must be performed by an ophthalmologist with experience 
with trabeculectomy and bleb management.  
You can find this information in the Local Coverage Determination (LCD) Micro-Invasive Glaucoma Surgery 
(MIGS) L37531. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.