RetiredUnitedHealthcarePolicy CS050LA.U

Glaucoma Surgical Treatments (for Louisiana Only) Retired April 1, 2026

Medical policy governing surgical and laser treatments for glaucoma for Louisiana Medicaid members and providers, including which procedures are considered proven/medically necessary and listed procedure codes for reference.

Policy Summary

PayerUnitedHealthcare

PolicyGlaucoma Surgical Treatments (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CS050LA.U

Change TypeRetirementCPT list update

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionVerify plan-specific prior authorization and coverage requirements and confirm CPT code 1012T inclusion for Louisiana membership.

SourceLink

POLICY UPDATE CHANGES

Applicable CPT codes were updated to reflect annual edits and code 1012T was added.

Policy retired for Louisiana plan membership disenrolled on Apr. 1, 2026.

Retired policy; Louisiana plan membership disenrolled on Apr. 1, 2026.

Updated list of applicable CPT codes to reflect annual edits; added 1012T.

1policy retired for LA membership

1CPT code added

State-specificpolicy applies to

Pediatric

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goniotomy/trabeculotomy pediatric

>10procedures listed

Coverage Criteria and Evidence Summaries

Evidence‑quality constraints for novel/laser procedures

Evidence-quality constraints for novel/laser procedures

Evidence for novel or emerging laser procedures (for example, excimer laser trabeculostomy/trabeculotomy (ELT), femtosecond laser trabeculotomy (FLT), optical coherence tomography (OCT)-guided laser trabeculotomy, and other nonstandard laser approaches) is limited and generally low in quality. Published studies are frequently single-arm, single-center, nonrandomized, or have small sample sizes, which increases risk of bias and limits generalizability.

Randomized controlled trials (RCTs) with adequate sample size, appropriate masking where feasible, prespecified primary outcomes, and sufficient duration of follow-up are generally lacking for these procedures. The absence of well‑designed RCTs prevents robust conclusions about comparative effectiveness and long‑term safety.

Many available reports are early phase, pilot, or device‑sponsored case series. Typical methodological limitations include lack of control groups, short follow‑up (often ≤ 12 months), heterogeneous patient populations and endpoints, variable definitions of success, and incomplete adverse event reporting.

Meta-analyses and systematic reviews that include these technologies are often constrained by high between‑study heterogeneity (I2), inconsistent outcome measures, and pooled data dominated by observational studies. These factors reduce confidence in pooled estimates of IOP reduction or medication reduction.

Regulatory status: several of these laser procedures are not FDA‑cleared for glaucoma indications in the US. Lack of regulatory approval for glaucoma use further limits available evidence and may indicate that safety and efficacy have not been established for the indication.

Operational implication: given the low or very low certainty of evidence, these novel or laser trabeculotomy procedures should be considered investigational/experimental and not medically necessary outside of well‑designed clinical trials that include appropriate informed consent and prospective data collection.

Procedure and Device Codes

Applicable procedure and device codes (examples)mixed

0253T	Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the suprachoroidal space.
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 (List separately in addition to code for primary procedure).
0474T	Insertion of anterior segment aqueous drainage device, with creation of intraocular reservoir, internal approach, into the supraciliary space.
0621T	Trabeculostomy ab interno by laser.
0622T	Trabeculostomy ab interno by laser; with use of ophthalmic endoscope.
0671T	Insertion of anterior segment aqueous drainage device into the trabecular meshwork, without external reservoir, and without concomitant cataract removal, one or more.
0730T	Trabeculotomy by laser, including optical coherence tomography (OCT) guidance.
1012T	Motorized ab interno trephination of sclera (sclerostomy), or trabecular meshwork (trabeculostomy), 1 or more, including injection of antifibrotic agents, when performed.
65820	Goniotomy.

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Procedures discussed (no explicit billing codes provided)mixed

affected codes

The document text in these chunks does not list explicit CPT/HCPCS/ICD-10 codes; placeholder reflects absence of specific billing codes in this excerpt.

FDA-cleared devices/procedures referencedmixed

K062259	iTRACK Ophthalmic Microcannula (Canaloplasty Ophthalmic Microcannula).
K211680	Streamline Surgical System (Streamline Viscoelastic Injector).
K030350	ExPRESS Mini Glaucoma Shunt.
K161457	XEN Glaucoma Treatment System.
P170043	iStent inject PMA (iStent inject Trabecular Micro-Bypass System).
GTS100R/L	iStent Model designation (GTS100R/L) FDA-approved for use with cataract surgery.
P170034	Hydrus Microstent (PMA P170034).

Applicable CPT Codes (updated)CPT

1012T

Added in applicable CPT codes list

Updated Applicable CPT Codes (excerpt)CPT

1012T

CPT code added to applicable codes list

MIGS effectiveness threshold

MIGS effectiveness thresholdAt least 20% reduction in intraocular pressure (IOP) OR reduction of at least one glaucoma medication

Intended patient populationTypically mild-to-moderate glaucoma patients undergoing ab interno procedures, often combined with cataract surgery

Clinical implicationProcedures not meeting this threshold are considered to have insufficient efficacy to qualify as effective MIGS in cited guidance

Reported postoperative target ranges (IOP 6 6 18 mmHg)

Reported postoperative target rangeIn reported studies, target postoperative IOP commonly reported between 6 and 18 mmHg inclusive

Provider Steps, Prior Authorization, and Documentation

Prior Authorization

Prior authorization — evidence & documentation

Prior authorization evidence and likely required documentation: Prior authorization may be required by plan-specific rules — when requested include clinical evidence of diagnosis, prior therapies tried, baseline and washout IOP measurements, medication list, indication for procedure (e.g., combined with phacoemulsification), and device labeling/indication documentation (FDA approval statements when applicable). Provide study-defined failure criteria when relevant (see items).

Required: patient diagnosis, current IOP and measurement method, number and names of ocular hypotensive medications, prior medical/surgical therapy history, rationale for procedure (why chosen over alternatives).
Suggested: relevant study outcome definitions (e.g., failure defined as additional filtering surgery, loss of light perception, or IOP ≥ 21 mmHg on meds on two consecutive visits).
Device-specific: cite FDA indication (e.g., iStent, Hydrus, XEN) if implant is being used; note if device is approved only in combination with cataract surgery (off‑label standalone use may affect coverage).

Note

Prior authorization not specified in excerpt

Prior authorization not specified in the excerpt: the policy text includes an applicable codes list and clinical guidance but does not uniformly specify a universal prior authorization rule for each procedure. Verify plan-specific prior authorization requirements and fee-schedule edits for covered members before scheduling.

Background and Scope

Background: Glaucoma is a group of progressive optic neuropathies associated with elevated intraocular pressure that can lead to optic nerve damage and visual field loss. Disease severity is categorized clinically (mild, moderate, severe) based on optic nerve and visual field findings. A range of surgical and laser interventions—ab interno and ab externo approaches, MIGS, glaucoma drainage devices, trabeculectomy, and cyclodestructive procedures—aim to lower intraocular pressure by improving aqueous outflow or reducing aqueous production; choice of procedure depends on disease severity, prior treatments, and the target IOP.

Definitions and Terms

Primary open-angle glaucoma (POAG)

DefinitionPrimary open-angle glaucoma (POAG) is a chronic, progressive optic neuropathy with optic nerve atrophy and retinal ganglion cell loss; adult onset with open anterior chamber angles and absence of other explanations for progressive glaucomatous change

Characteristic featuresEvidence of optic nerve damage (disc or RNFL abnormalities) and reproducible visual field abnormality

Severity classificationSeverity may be categorized as mild, moderate, severe, or indeterminate based on optic nerve/RNFL and visual field testing

Canaloplasty / Ab interno canaloplasty

DefinitionCanaloplasty (including ab interno canaloplasty) restores natural aqueous drainage by viscodilation of Schlemm's canal; ab interno uses a corneal/limbal incision to insert a microcatheter and dilate the canal with viscoelastic

Mechanism

Policy Revision History

2026-04-01policy_retirementLatest

Policy retired for Louisiana plan membership; Louisiana membership disenrolled under this policy.

2026-02-01code_update

Applicable CPT codes updated to reflect annual edits and CPT code 1012T was added to the policy's code list.

Policy Summary

PayerUnitedHealthcare

PolicyGlaucoma Surgical Treatments (for Louisiana Only) Retired April 1, 2026

Policy CodePolicy CS050LA.U

Change TypeRetirementCPT list update

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionVerify plan-specific prior authorization and coverage requirements and confirm CPT code 1012T inclusion for Louisiana membership.

SourceLink

On This Page

Code lists are informational only — inclusion does not equal PA determination or guarantee of payment.
Check the member's federal/state/contractual benefit requirements; in event of conflict, those govern coverage.

Prior Authorization

Prior authorization — combined canaloplasty + trabeculotomy

Prior authorization — combined canaloplasty/trabeculotomy (OMNI, Streamline): studies report efficacy when performed with phacoemulsification in mild–moderate OAG. Evidence limitations (small sample sizes, short follow-up, lack of control groups) exist; prior authorization requests for standalone or non‑FDA indicated uses should include detailed rationale and supporting literature.

Include IOP baseline (washout if available) and the IOP measurement protocol used in study (9 AM/12 PM/4 PM Goldmann applanation tonometry with two measurements averaged).
Provide prior treatment history and rationale for combining with cataract surgery.
If seeking coverage for standalone canaloplasty/trabeculotomy (ab interno) include evidence supporting effectiveness vs combined use.

Note

Prior authorization — administrative check

Prior authorization not specified in this excerpt (additional context): for many MIGS devices and procedures the policy summarizes evidence and FDA indications but does not mandate PA; confirm with plan-specific administrative rules and state/federal mandates.

Confirm PA for device implantation (some plans may require PA for implants or for use outside of FDA-labeled indications).
When in doubt, submit pre-service inquiry with required documentation listed below.

Prior Authorization

Prior authorization recommended when evidence is limited

Prior authorization recommended for procedures with limited or evolving evidence (e.g., OCT‑guided laser trabeculotomy, newer canaloplasty devices, other laser procedures): because evidence is insufficient or low quality, include robust clinical justification and supporting literature when requesting authorization.

Provide prior therapy history, objective IOP data, reason other established treatments are unsuitable, and anticipated clinical benefit.
Flag procedures that are investigational/experimental per evidence reviews — these may be denied without strong supporting documentation.

Billing Rule

Applicable Codes / Prior Authorization (plan-specific)

Applicable Codes / Prior Authorization: Code listing in this policy is informational only; listing does not imply coverage or prior authorization status. Verify plan-specific PA lists and annual code edits before billing.

Examples of referenced CPT/HCPCS codes are provided in the policy (e.g., 0253T, 0449T, 0450T, 0474T, 0621T, 0622T, 0671T, 0730T, 1012T, 65820, 65855, 66174, 66175, 66179–66183).
Inclusion of a code is informational only and does not guarantee reimbursement or indicate PA requirement.

Note

Code listing is informational only

Code listing is informational only: inclusion of a code does not imply that the service is covered, reimbursable, or requires prior authorization. Always check the member's benefit plan and applicable laws or contractual requirements.

Use the federal/state/contractual benefit documents to determine actual coverage.
UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in benefit administration; this policy does not replace plan terms.

Documentation Required

Study-defined failure criteria — document for PA

Study-defined failure criteria (relevance to outcomes/authorization): some clinical studies define failure thresholds (e.g., need for additional filtering surgery; visual acuity deterioration to no light perception; IOP ≥ 21 mmHg on meds on two consecutive visits). When submitting PA, include whether the patient meets published failure definitions where relevant.

If relying on study outcomes, document how the patient’s clinical course meets or differs from study failure/success criteria.
Include dates and values of consecutive IOP readings if invoking study-defined failure thresholds.

Note

Not applicable / informational content

Not applicable content in this section: some policy content (background, broader evidence summaries) is informational and not actionable for PA decisions. Clinicians should extract and submit only the required clinical elements listed below when requesting authorization.

Background evidence summaries and general device/evidence statements are not substitutes for individualized clinical documentation.
Omit nonessential narrative when completing PA forms — focus on diagnosis, objective measures, prior therapy, and device labeling.

Denial Risk

Evidence limitations may trigger denial

Evidence limitations may trigger denial: where high-quality RCT data are lacking, sample sizes are small, follow-up is short, or studies are retrospective, payers may deny coverage or request additional documentation. Expect denials or requests for more information for investigational or insufficiently supported procedures.

Procedures with low-quality or inconsistent evidence (e.g., some laser procedures, novel ab interno canaloplasty without robust RCT support) are higher denial risk.
Include longer-term outcomes or comparative data when available to strengthen PA requests.

Note

State-specific policy retirement / effective dates

State-specific retirement: this policy version notes retirement for the Louisiana plan (membership disenrolled effective Apr 1, 2026). For members formerly covered under that plan, follow current plan assignment and effective dates.

04/01/2026 — policy retired for Louisiana; verify member enrollment and applicable policy catalog.
02/01/2026 — applicable code list updated (added 1012T).

Note

Coverage determination — reference governing benefit documents

Coverage determination note: when deciding coverage, reference federal, state, or contractual benefit requirements; in case of conflict, those requirements govern. This Medical Policy is informational and does not replace plan terms or laws.

UnitedHealthcare may modify policies; verify current version and any third‑party clinical criteria used (eg InterQual).
The Medical Policy does not constitute medical advice—use in conjunction with clinician judgment.

Documentation Required

Required clinical documentation elements for PA

Required clinical documentation elements: to support authorization include diagnosis, prior medical and surgical glaucoma treatments, baseline IOP (with measurement method and times), medication list, and objective findings (gonioscopy, OCT, visual fields) when relevant.

Document baseline and most recent IOP values, including whether washout was performed and measurement protocol (time-of-day and device).
List prior medication classes and surgical procedures with dates and outcomes.
Provide objective ocular exam findings (e.g., gonioscopy results, optic nerve/visual field status).

Documentation Required

Suggested clinical documentation to strengthen PA requests

Suggested clinical documentation: include indication, baseline IOP and washout values, rationale for chosen procedure, prior therapy failures or contraindications, device FDA indication statements, and relevant study data or guidelines supporting the intervention.

Attach pertinent study abstracts or guideline excerpts if procedure is borderline/marginal in evidence.
For combined cataract + MIGS procedures, document cataract significance and plan to perform phacoemulsification concurrently if device is FDA‑approved only in combination with cataract surgery.

Documentation Required

IOP measurement protocol — document method & timing

IOP measurement protocol (study): some studies (e.g., GEMINI/Pyfer) measured IOP at defined times (9 AM ±1.5 hr, 12 PM ±1 hr, 4 PM ±2 hr) using Goldmann applanation tonometry with two measurements averaged per time point. When available, submit measurement protocol used and timing of recorded IOPs.

If study outcomes are used for comparison, supply measurement times and methods to match study protocols where possible.
State whether measurements were taken on or off medications and whether washout was performed.

Documentation Required

Device indication & FDA documentation

Device indication documentation: include FDA approval status and indication for the specific device (e.g., iStent, iStent inject, Hydrus approved only in combination with cataract surgery; XEN and other devices have specific approvals). For off‑label or standalone uses, provide clinical justification and supporting evidence.

Cite PMA/K numbers or approval dates when relevant (policy includes FDA approval dates/info).
If device use is outside the labeled indication, note this explicitly and include rationale and literature support.

Note

When deciding coverage, reference governing benefit documents

When deciding coverage, reference federal, state, or contractual requirements: benefit coverage is governed by the member’s plan documents and applicable laws. This policy is a guide and may be superseded by those documents.

In event of conflict, federal/state/contractual requirements govern coverage decisions.
Check member-specific PA and coverage rules before scheduling procedures.

Step Therapy

Step therapy — context & verification

Step therapy context: the policy summarizes therapeutic sequencing (medical therapy, laser, MIGS, filtration/shunt) but does not impose explicit step therapy rules. Verify plan-specific step therapy requirements and any prior authorization pathways before performing higher‑acuity procedures.

No universal step therapy rule provided in excerpt — some plans may require trials of medications or laser (eg SLT) prior to MIGS or filtration.
Document prior therapeutic trials (medications/laser) if relevant to PA or step therapy requirements.

Step Therapy

Step therapy — SLT positioning and documentation

Step therapy context for SLT: evidence (eg LIGHT trial) supports SLT as an initial or adjunctive therapy for POAG/OHT and may be considered before escalating to MIGS or incisional surgery. If plan requires trials of SLT prior to other procedures, document outcomes of SLT.

LIGHT trial: long‑term data showing SLT provided better disease control vs drops at 6 years — include SLT treatment date and response if relevant.
If SLT was ineffective or contraindicated, document reasons to support proceeding to other interventions.

Step Therapy

Step therapy — LPI and LPIp context

Step therapy positioning of LPI and LPIp: laser peripheral iridotomy (LPI) has demonstrated benefit in primary angle‑closure suspect; laser peripheral iridoplasty (LPIp) is typically second‑line when residual appositional angle closure persists after LPI. Document prior LPI and response when considering LPIp or other procedures.

For PACS/PAC/PACG, provide LPI date and clinical response; note if LPIp is being considered as adjunctive therapy.
Cochrane and RCT evidence summarized — LPIp has limited evidence for IOP reduction; document clinical rationale.

Note

No step therapy requirements specified in policy excerpt

No step therapy requirements specified: the policy excerpt does not set mandatory step therapy for most procedures. Confirm member-specific plan requirements for step therapy or prior treatments prior to authorization.

When no step therapy is specified, supply customary prior treatment history to support medical necessity.
Plans may still enforce utilization management rules even if policy is silent.

Step Therapy

Step considerations vs filtration/shunt surgery

Step considerations relative to filtration/shunt surgery: AAO guidance and systematic reviews note that combined cataract + glaucoma procedures are sometimes less effective than filtration alone and that filtration (trabeculectomy, aqueous shunt) may be preferred for patients requiring lower target IOP. Document why MIGS or combined approaches are clinically appropriate when a filtration procedure might otherwise be indicated.

If patient requires very low target IOP or has prior incisional surgery, explain why a shunt or trabeculectomy is not selected (or document contraindication).
Provide comparative rationale when selecting MIGS vs trabeculectomy/aqueous shunt.

Documentation Required

Device-labeled combination use — document cataract concurrence

Device-labeled combination use: some devices (iStent, iStent inject, Hydrus) are FDA‑approved only for use in combination with cataract surgery. Standalone implantation is off‑label and may affect coverage — document cataract status and planned concurrent phacoemulsification when using these devices.

Confirm whether the device’s PMA/PMA supplement indicates combination use only and attach FDA documentation.
If planning standalone device use, provide justification and supporting evidence for off‑label use.

Vismodilation of Schlemm's canal to improve distal and collector channel outflow; may be combined with trabeculotomy to address trabecular resistance

Devices/approachesExamples include OMNI, VISCO360, Streamline, and iTRACK microcannula for canaloplasty/viscodilation

MIGS (definition)

DefinitionMicroinvasive glaucoma surgery (MIGS) denotes ab interno, minimally disruptive procedures—often combined with cataract surgery—that lower IOP with lower complication risk than traditional filtering surgeries

Efficacy expectationMIGS typically offers more modest IOP lowering than trabeculectomy or shunt surgery; postoperative pressures often in mid-to-upper teens

Common targetsMIGS target patients: adults with mild-to-moderate OAG seeking modest IOP reduction and medication burden reduction

Goniotomy / Trabeculotomy

DefinitionGoniotomy and trabeculotomy are angle-based procedures that incise or excise the trabecular meshwork to reduce outflow resistance; goniotomy is performed via an internal approach and trabeculotomy incises the TM and inner wall of Schlemm's canal

Typical useGoniotomy/trabeculotomy are commonly used in pediatric glaucoma and are evaluated in adults combined with phacoemulsification

Examples/devicesProcedures may use instruments such as Kahook Dual Blade (KDB), Trabectome, or microcatheter-assisted GATT

MIGS examples (iStent, Hydrus)

ExamplesiStent (first generation) and iStent inject (second generation) are trabecular micro-bypass stents placed ab interno to reduce IOP and medication burden when used with cataract surgery

Clinical evidenceRCTs and meta-analyses report greater short- to mid-term reductions in IOP and medication use when iStent devices are combined with phacoemulsification versus phaco alone

NotesiStent inject received FDA PMA and is approved only in combination with cataract surgery (standalone use is off-label)

EX-PRESS

DefinitionEX-PRESS Mini Glaucoma Shunt is a glaucoma drainage device implanted to lower IOP in patients where medical and conventional surgical treatments have failed

Comparative outcomesMeta-analysis of RCTs found EX-PRESS provided better IOP percentage reduction and higher complete success at 1 year versus trabeculectomy with fewer certain complications

Regulatory statusReceived FDA 501(k) clearance (K030350) for use in reduction of IOP when other treatments have failed

Complete success (definition placeholder)

Complete success (policy term)Complete success defined in cited analyses as achieving target endpoint IOP without antiglaucoma medication

Usage noteUsed as an efficacy endpoint in RCTs comparing drainage devices to trabeculectomy

Comparative findingEX-PRESS group had higher complete success at 1 year (OR = 3.26) in pooled RCTs

Qualified success (definition placeholder)

Qualified success (policy term)Qualified success defined as achieving target endpoint IOP with or without antiglaucoma medication

ContextReported alongside complete success in comparative trials to capture outcomes not requiring medication-free status

Comparative findingNo significant difference in qualified success between EX-PRESS and trabeculectomy in pooled trials

Primary angle-closure (PAC)

DefinitionPrimary angle-closure (PAC) in the cited RCT was defined by presence of peripheral anterior synechiae (PAS), intraocular pressure >21 mmHg, or acute angle closure

Clinical evidenceProphylactic laser peripheral iridotomy (LPI) reduced progression endpoints over 5 years in PACS subjects (5.0% vs 9.4%)

Study contextBaskaran et al. randomized one eye to LPI and used fellow eye as control in participants >50 years with bilateral PACS

Cyclodestructive procedures (definition)

DefinitionCyclodestructive procedures (cyclophotocoagulation) destroy ciliary body tissue to reduce aqueous production and lower IOP, used for refractory glaucoma

Evidence summaryCochrane review found evidence inconclusive vs other treatments; trials small with limited reporting

Adverse eventsCommonly reported AEs include hypotony and phthisis bulbi

OMNI surgical system

Clinical useUsed to perform combined canaloplasty (viscodilation) and trabeculotomy, often with phacoemulsification

Regulatory noteDescribed in FDA device section as an FDA-regulated device (product codes MRH/HMZ) with informational details provided

Kahook Dual Blade (KDB) goniotomy

DefinitionKahook Dual Blade (KDB) goniotomy is an excisional goniotomy using a dual-blade device to remove a strip of trabecular meshwork to enhance aqueous outflow

Clinical evidenceMultiple comparative and observational studies report that phaco-KDB yields greater early IOP and medication reductions versus phaco alone and versus some stent procedures

Common AEsHyphema and transient IOP spikes commonly reported; bleeding-related events higher than some stents in series

GATT (gonioscopy-assisted transluminal trabeculotomy)

DefinitionGATT (gonioscopy-assisted transluminal trabeculotomy) is an ab interno 360-degree trabeculotomy performed using an illuminated microcatheter or suture to open Schlemm's canal

Clinical outcomesCase series and reviews report substantial IOP reduction and decreased medication use, though most data are non-comparative

Typical indicationsUsed in adult OAG and pediatric cases; may be combined with cataract surgery

MIGS (term repeated in definitions)

MIGS term (repeat)MIGS: minimally invasive glaucoma surgeries targeting TM/Schlemm's canal or subconjunctival space; often combined with cataract surgery and offering favorable short-term safety

Performance noteMIGS typically produce modest IOP reductions versus traditional filtration surgery and have limited long-term data

Regulatory/labelingSome MIGS devices are approved only when performed concurrently with cataract surgery (e.g., iStent inject, Hydrus)

Canaloplasty/Viscodilation devices

Device classCanaloplasty/viscodilation devices (e.g., iTRACK microcannula, Streamline Surgical System, OMNI) microcatheterize and viscodilate Schlemm's canal; OMNI also performs trabeculotomy

ExamplesiTRACK (K062259), Streamline (K211680), OMNI Surgical System (described in FDA summaries)

Clinical evidenceCase series and interim study reports suggest IOP and medication reductions but randomized comparative data are limited

iStent / iStent inject

DeviceiStent and iStent inject are trabecular micro-bypass stent systems placed ab interno to improve trabecular outflow; approved for use in combination with cataract surgery

Approval notesiStent GTS100R/L approved 2012; iStent inject PMA (P170043) approved 2018; iStent inject is indicated only with cataract surgery

Clinical findingsRCTs show greater reductions in unmedicated diurnal IOP and medication use when implanted with phacoemulsification versus phaco alone

Hydrus Microstent

DeviceHydrus Microstent is a Schlemm's canal scaffold microstent approved for use with cataract surgery to reduce IOP in mild to moderate POAG

Comparative dataNetwork meta-analysis suggests Hydrus combined with phaco may achieve greater IOP lowering than 1- or 2-iStent constructs in some analyses

Regulatory statusHydrus PMA (P170034) approved August 10, 2018 for use with cataract surgery

ExPRESS device

DeviceExPRESS Mini Glaucoma Shunt (ExPRESS) is a small glaucoma drainage device indicated to reduce IOP when medical and conventional surgical treatments have failed

EvidenceMeta-analysis of RCTs found EX-PRESS offered better percent IOP reduction and higher complete success at 1 year versus trabeculectomy

Regulatory noteExPRESS (K030350) cleared by FDA; predicate devices include Molteno, Baerveldt, Ahmed valves

Eagle SLT laser

DeviceEagle is a Q-switched 532 nm Nd:YAG laser intended for selective laser trabeculoplasty (SLT)

ApprovalEagle device (K230722) approved by FDA Dec 12, 2023 for laser glaucoma treatment including SLT

Clinical contextSLT is supported as initial or adjunctive therapy for POAG with durable control demonstrated in randomized trials (e.g., LIGHT)

References (clinical literature and manufacturer resources)

Literature and resourcesPolicy cites peer-reviewed studies, systematic reviews, HTAs, and device manufacturer/FDA summaries as references to support clinical statements

Example citationsIncluded references: Cochrane reviews, ECRI assessments, RCTs (e.g., Samuelson iStent inject study), and device FDA PMA/PMN summaries

Usage noteReferences listed to support evidence summaries; consult primary sources for detailed methods and outcomes

Operational guidance to check federal/state/contractual benefit requirements

Operational guidanceBefore relying on this policy for coverage decisions, check applicable federal, state, or contractual benefit plan requirements as they govern in case of conflict

Policy purposePolicy is informational and assists interpretation of standard benefit plans but does not constitute medical advice

Action for providersVerify plan-specific prior authorization, fee schedule, and benefit limits prior to billing or performing procedures