Currentselect_healthPolicy CCP.1510

XEN® gel stent for glaucoma

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Policy governing medical necessity and coverage limitations for implantation of the XEN45 gel stent for glaucoma, including clinical indications, provider requirements, and alternative covered services for Select Health of South Carolina members.

Policy Summary

Payerselect_health

PolicyXEN® gel stent for glaucoma

Policy CodePolicy CCP.1510

Change TypeNo material change

Effective DateApr 1, 2022

Last ReviewMar 1, 2026

Next Review DateJul 1, 2027

Key ActionObtain prior authorization confirming medical necessity and that only one XEN45 device per eye will be provided.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one per eyemaximum devices allowed

≥20 mm HgIOP threshold

≥4 classesmax medical therapy

2016FDA clearance year

0449T,0450T,66183

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Currentselect_healthPolicy CCP.1510

XEN® gel stent for glaucoma

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Policy Summary

Payerselect_health

PolicyXEN® gel stent for glaucoma

Policy CodePolicy CCP.1510

Change TypeNo material change

Effective DateApr 1, 2022

Last ReviewMar 1, 2026

Next Review DateJul 1, 2027

Key ActionObtain prior authorization confirming medical necessity and that only one XEN45 device per eye will be provided.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one per eyemaximum devices allowed

≥20 mm HgIOP threshold

≥4 classesmax medical therapy

2016FDA clearance year

0449T,0450T,66183

lowerefficacy vs trabeculectomy

Coverage Criteria for XEN45 Gel Stent

Initial therapy / Medical necessity

Covered when ALL of the following are met:

XEN45 medical necessity: 1) Diagnosis of glaucoma with either prior failure of a filtering or cilioablative procedure AND/OR uncontrolled intraocular pressure defined as progressive glaucomatous damage with mean diurnal medicated intraocular pressure ≥ 20 mm Hg while on maximally tolerated medical therapy;mean diurnal medicated IOP ≥ 20 mm Hg

From Select Health coverage policy and supporting references (AAO, FDA).

Maximally tolerated medical therapy: 2) Member is on maximally tolerated medical therapy, defined as use of ≥ 4 classes of topical intraocular pressure–lowering medications (or fewer when limited by tolerability or efficacy).≥ 4 classes (or fewer if intolerant/ineffective)

Per policy definition of maximally tolerated medical therapy.

Provider and procedural requirement: 3) Procedure is to be performed by an ophthalmologist experienced with trabeculectomy and bleb management.

Required per FDA clearance and Select Health policy.

Select Health considers more than one XEN45 device per eye to be not medically necessary. This limitation is stated as a coverage restriction in the policy’s limitations section and applies to implantation of the XEN45 gel stent.

The policy lists commonly submitted procedure and device codes for XEN gel stent procedures but explicitly notes that this is not an exhaustive list. Providers are expected to consult applicable coding manuals and payer requirements when submitting claims.

XEN45 insertion is considered medically necessary only when the stated clinical criteria are met. Procedures performed in patients who do not meet those criteria — for example, those without prior failure of a filtering or cilioablative procedure and without evidence of uncontrolled intraocular pressure (progressive damage and mean diurnal medicated IOP ≥ 20 mm Hg) on maximally tolerated medical therapy — are not supported as medically necessary under this policy.

Within the provided excerpts there are no additional explicit statements listing other specific conditions considered not medically necessary beyond the limitation on device quantity and the general medical necessity criteria. The policy directs providers to the documented criteria and to coding guidance for procedure and device reporting.

Coding and Clinical Thresholds

Related Codes / Commonly submitted codesmixed

0449T	Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; initial device
0450T	Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; each additional device
66183	Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach
0012T	Glaucoma drainage device procedure (new Category III code effective 1/1/2026)
C1783	Ocular implant, aqueous drainage assist device (HOPD device code)
L8612	Aqueous shunt (ASC/commercial device code)

Related Codes / Commonly submitted codes (duplicate group for system clarity)mixed

0449T	Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; initial device
0450T	Insertion of aqueous drainage device, without extraocular reservoir, internal approach, into the subconjunctival space; each additional device
66183	Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach
0012T	Glaucoma drainage device procedure (new Category III code effective 1/1/2026)
C1783	Ocular implant, aqueous drainage assist device (HOPD device code)
L8612	Aqueous shunt (ASC/commercial device code)

inv-07: Mean diurnal medicated intraocular pressure — threshold noted

Mean diurnal medicated IOP thresholdMean diurnal medicated intraocular pressure ≥ 20 mm Hg

Context for thresholdUsed to define uncontrolled IOP when accompanied by progressive optic nerve/visual field damage

Measurement conditionMedicated (on current topical IOP‑lowering therapy) and expressed as mean diurnal value

inv-08: Maximally tolerated medical therapy — definition (≥ 4 classes or fewer if intolerant)

DefinitionMaximally tolerated medical therapy = use of ≥ 4 classes of topical intraocular pressure–lowering medications

Exception for intolerance/efficacyFewer than 4 classes acceptable when limited by tolerability or inadequate efficacy

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; one device per eye limit

Prior authorization is required to confirm that medical necessity criteria are met and to ensure only one XEN45 device will be provided per eye. Authorization must document that the patient meets the policy criteria (prior failure of a filtering/cilioablative procedure and/or uncontrolled IOP on maximally tolerated medical therapy) and that the procedure will be performed by an ophthalmologist experienced with trabeculectomy and bleb management.

Confirm member meets criteria: prior filtering/cilioablative failure and/or uncontrolled IOP (progressive damage; mean diurnal medicated IOP ≥ 20 mm Hg) on maximally tolerated medical therapy (≥ 4 topical classes or fewer if intolerant/ineffective).
Verify that only one XEN45 device is planned per eye (policy limitation).
Confirm surgeon qualifications: ophthalmologist experienced with trabeculectomy and bleb management.

Prior Authorization

Verify prior authorization for listed procedure/device codes

Verify prior authorization requirements for commonly submitted procedure and device codes used for XEN gel stent procedures; consult payer authorization processes for these codes before scheduling.

Background and Clinical Context

Glaucoma is a chronic, progressive optic neuropathy in which elevated intraocular pressure (IOP) is a major modifiable risk factor. First-line management typically includes topical IOP-lowering medications and selective laser trabeculoplasty; patients who continue to progress or have uncontrolled IOP despite medical therapy may require surgical interventions. The XEN45 gel stent is a small, 6‑mm gelatin tube implanted to create subconjunctival filtration and received FDA 510(k) clearance in 2016. Select Health’s policy frames XEN45 as potentially medically necessary for refractory cases when performed by an ophthalmologist experienced with trabeculectomy and bleb management, and when objective thresholds such as mean diurnal medicated IOP ≥ 20 mm Hg on maximally tolerated medical therapy (≥ 4 classes of topical agents, or fewer if intolerant/ineffective) are met.

Definitions

inv-18: XEN45 gel stent — device description and typical placement

Device descriptionXEN45 gel stent: a 6‑millimeter gelatin (porcine collagen/gelatin) tube with a 45‑micron lumen that creates an outflow from the anterior chamber to the subconjunctival space

Typical placement approachDesigned primarily for ab interno implantation into the subconjunctival space; ab externo techniques have also been described

FunctionForms a subconjunctival filtration bleb to lower intraocular pressure

inv-19: Maximally tolerated medical therapy — defined as ≥ 4 classes of topical IOP-lowering meds or fewer if intolerant

Coverage definitionMaximally tolerated medical therapy defined as ≥ 4 classes of topical IOP‑lowering medications

Allowance for fewer classes

Policy Summary

Payerselect_health

PolicyXEN® gel stent for glaucoma

Policy CodePolicy CCP.1510

Change TypeNo material change

Effective DateApr 1, 2022

Last ReviewMar 1, 2026

Next Review DateJul 1, 2027

Key ActionObtain prior authorization confirming medical necessity and that only one XEN45 device per eye will be provided.

SourceLink

On This Page

Role in coverageRequired to document uncontrolled IOP on maximally tolerated medical therapy for medical necessity of XEN45

Commonly submitted codes include: 0449T, 0450T, 66183, 0012T, C1783, L8612.
This list is not exhaustive — consult coding manuals and payer-specific prior authorization tools.

Note

Consider alternative covered surgical options

Consider conservative and alternative surgical options before XEN45 insertion; trabeculoplasty and trabeculectomy are listed as alternative covered services.

Document consideration of alternatives such as trabeculoplasty or trabeculectomy in the clinical record when applicable.

Step Therapy

Step therapy — no requirements specified

No step therapy requirements are specified in the provided policy excerpts.

Proceed with prior authorization and documentation per policy; do not expect mandated step therapy sequences in these excerpts.

Documentation Required

Document prior filtering/cilioablative failure and uncontrolled IOP

Document prior failure of a filtering or cilioablative procedure and/or evidence of uncontrolled IOP on maximally tolerated medical therapy to support medical necessity for XEN45 insertion.

Include records showing progressive optic nerve damage or mean diurnal medicated IOP ≥ 20 mm Hg.
Show trials of maximally tolerated medical therapy (typically ≥ 4 classes of topical IOP-lowering medications or fewer if intolerant/ineffective).
Document prior procedures and their outcomes to demonstrate failure.

Billing Rule

Procedure documentation and coding — document device and use appropriate codes

Document the procedure performed and the specific device used, and bill using the appropriate procedure and device codes listed in the policy; the provided code list is guidance and not exhaustive.

Record the exact procedure (e.g., ab interno XEN45 insertion) and device details in the operative report.
Use appropriate codes such as 0449T (initial device), 0450T (additional device), 66183, 0012T, C1783, or L8612 as applicable while consulting coding manuals.

Denial Risk

Denial risk for procedures not meeting medical necessity

Procedures that do not meet the policy's medical necessity criteria — for example, XEN45 insertion without prior failure of a filtering/cilioablative procedure and/or without uncontrolled IOP on maximally tolerated medical therapy — may be denied.

Ensure documentation supports prior failure and uncontrolled IOP before submitting authorization/claims to reduce denial risk.

Denial Risk

Coding-related denial risk — bill appropriate procedure/device codes

Failure to bill appropriate procedure or device codes listed in the policy may result in coding or claim issues; consult coding manuals and payer guidance when submitting claims.

Verify code selection (0449T, 0450T, 66183, 0012T, C1783, L8612) matches the documented procedure and device.
Confirm correct use of initial vs. additional device codes (e.g., 0449T vs 0450T) when multiple devices are involved — noting only one device per eye is medically necessary per policy.

Fewer than 4 classes acceptable when limited by tolerability or lack of efficacy

Documentation expectationProviders should document medication classes tried and reasons (intolerance or ineffectiveness) for fewer than 4 classes

inv-20: XEN Glaucoma Treatment System — FDA-reviewed subconjunctival injectable gel stent system (K161457)

Regulatory statusXEN Glaucoma Treatment System received FDA 510(k) clearance (K161457) on November 21, 2016

System componentsIncludes an injector and a single‑piece gelatin tube (subconjunctival injectable gel stent system)

Indications noted by FDACleared for management of refractory glaucomas including cases unresponsive to maximal tolerated medical therapy