Aetna Glaucoma Surgery Coverage Update | OpenPayer
CurrentAetnaPolicy 0484
Glaucoma Surgery
Defines Aetna's medical necessity, experimental/investigational determinations, and coding guidance for glaucoma surgical treatments and related devices; applies to Aetna members and providers rendering glaucoma surgical care.
Policy Summary
PayerAetna
PolicyGlaucoma Surgery
Policy CodePolicy 0484
Change TypeNo material change
Effective DateJun 8, 2001
Next Review DateMay 9, 2024
Key ActionObtain and document prior therapies and clinical measures (baseline IOP, prior medication/surgery) to support medical necessity for glaucoma implants.
No material clinical or coverage changes in this revision.
~90%POAG proportion
1-2iStent per eye
1Hydrus per eye
5-yr ECLCyPass safety signal
03/24/2023Last review
Clinical PolicyDocument type
Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.
Coverage Criteria
Medically necessary indications
Medically necessary when ALL of the following are met (as applicable to each intervention):
Laser trabeculoplasty or FDA‑approved aqueous drainage/shunt implants: For treatment of members with refractory primary open‑angle glaucoma when first‑line drugs (e.g., latanoprost or timolol) and second‑line drugs (e.g., brimonidine or dorzolamide) have failed to control intraocular pressure (IOP).failure of first‑ and second‑line medical therapy
Currently available implants include Ahmed, Baerveldt, Ex‑PRESS, glaucoma pressure regulator, Krupin‑Denver, Molteno, Schocket.
iStent Trabecular Micro‑Bypass Stent: One or two iStent devices per eye for adults with mild or moderate open‑angle glaucoma and a cataract when the individual is currently being treated with an ocular hypotensive medication and the procedure is performed in conjunction with cataract surgery.Concurrent cataract surgery and on medical therapy
Contraindications and limits (e.g., contraindicated in angle‑closure glaucoma and certain conditions; more than two stents is considered experimental).
Hydrus Microstent: Single Hydrus Microstent for adults with mild or moderate open‑angle glaucoma and a cataract when the individual is currently being treated with an ocular hypotensive medication and the procedure is performed in conjunction with cataract surgery.Concurrent cataract surgery and on medical therapy
Contraindicated in certain angle defects, angle‑closure, neovascular, malignant, traumatic, or uveitic glaucomas; more than one Hydrus per eye is considered experimental.
XEN Glaucoma Treatment System: For management of refractory glaucoma including cases where previous surgical treatment failed, primary open‑angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles unresponsive to maximum tolerated medical therapy.refractory glaucoma after maximum tolerated medical therapy
Covered for indicated uses per FDA clearance for refractory glaucoma.
Adjunctive therapies: Adjunctive use of anti‑fibrotic agents (e.g., mitomycin C) is considered medically necessary with the Ex‑PRESS mini glaucoma shunt only; adjunctive use with other shunt implants is experimental/investigational.use with Ex‑PRESS only
Systemic corticosteroids or adjunct antifibrotics with other shunts are considered investigational.
Combined glaucoma and cataract surgery: Considered medically necessary for persons with a visually significant cataract with uncontrolled glaucoma despite maximal medical therapy and/or laser trabeculoplasty.visually significant cataract and uncontrolled glaucoma
Procedure performed concurrently with phacoemulsification when indicated.
Experimental / Investigational
The following are considered experimental and investigational (NOT medically necessary):
iStent contraindications and limits: iStent is contraindicated for primary or secondary angle‑closure glaucoma (including neovascular glaucoma), retrobulbar tumor, thyroid eye disease, Sturge‑Weber syndrome, or other conditions causing elevated episcleral venous pressure; more than two iStents per eye is considered investigational.effectiveness not established
Hydrus contraindications and limits: Hydrus is contraindicated for birth defects of the anterior chamber angle, primary or secondary angle‑closure glaucoma (including neovascular), malignant glaucoma, traumatic glaucoma, and uveitic glaucoma; implantation of more than one Hydrus per eye is investigational.effectiveness not established
Transciliary and suprachoroidal approaches: Transciliary filtration (Fugo Blade), suprachoroidal shunts, and anterior segment aqueous drainage devices without extra‑ocular reservoir inserted by an internal approach (including specific non‑FDA approved devices such as DeepLight Gold Micro‑Shunt, Eyepass) are investigational.
Coverage positioning for surgical glaucoma interventions
Coverage is supported when surgical interventions are selected according to established clinical sequencing and indications:
Aqueous shunts (external drainage devices): Used primarily after failure of medical, laser, and conventional filtering surgery; appropriate for complex glaucomas or eyes with conjunctival scarring at high risk for trabeculectomy failure.failed conventional filtering surgery or high risk for failure
Examples include Ahmed, Baerveldt, Molteno, Krupin; principal long‑term complication is corneal endothelial failure; clinical failure ~10%/year.
Trabeculectomy: Standard filtering procedure to relieve IOP when medications and/or laser trabeculoplasty have failed.failed medical/laser therapy
Adjunctive anti‑fibrotic use per clinical judgment; established role before shunt implantation in many cases.
Evidence summaries and coverage-relevant findings for novel internal filtration and micro-bypass devices:
iStent (general evidence): Randomized and non‑randomized studies demonstrate that trabecular micro‑bypass stents implanted with cataract surgery produce greater IOP reduction and reduce medication burden versus cataract surgery alone, with favorable safety through follow‑up up to 48 months.follow‑up through 24–48 months reported
Craven et al. RCT and Samuelson iStent inject RCT demonstrate higher proportions achieving medication‑free IOP targets.
Hydrus evidence: RCTs of Hydrus plus cataract surgery versus cataract alone show higher proportions achieving ≥20% unmedicated MDIOP reduction and greater medication‑free rates at 24 months and sustained benefits at 5 years in HORIZON trial follow‑up.24‑month and 5‑year endpoints reported
Pfeiffer et al. and HORIZON trial provide primary effectiveness data.
XEN evidence:
Clinical alignment and device-label concordance
Evidence and device labeling indicate coverage considerations when ALL of the following clinical conditions align with trial populations and device indications:
Patient selection aligned with trials/device labeling: Patient has open‑angle glaucoma (POAG) of severity matching trial populations (mild‑to‑moderate for Hydrus/iStent with cataract; refractory or prior‑surgery failures for XEN), and documented washed‑out DIOP/MDIOP where applicable (commonly 21–36 or 22–34 mmHg in pivotal trials).MDIOP/DIOP within trial ranges when available
Trial ranges cited in iStent inject, Hydrus and pivotal studies.
Prior therapy and combined‑surgery context: For devices approved/cleared for use with cataract surgery (Hydrus, iStent), the procedure is performed concurrently with phacoemulsification if that is the intended indication; for devices cleared for refractory glaucoma (XEN), prior maximal tolerated medical therapy and prior surgical history should match clearance populations.prior medication/surgery documented
HORIZON and pivotal XEN trials required prior treatment status per enrollment.
Coverage criteria aligned with trial populations
Covered when ALL of the following clinical features (as used in key studies) are present:
Study‑like eligibility: Patient has open‑angle glaucoma uncontrolled on maximum‑tolerated medical therapy or has failed prior filtering/cilio‑ablative procedures.
Derived from Grover et al. and Hengerer et al. study populations.
IOP range: Baseline medicated IOP approximately between 20 and 35 mmHg in refractory study cohorts.20-35 mmHg
Enrollment criteria in refractory XEN studies and Grover cohort.
Angle status: Open anterior chamber angles (not angle‑closure); if angle‑closure history exists, angle must have been surgically opened prior to device placement when indicated.
XEN contraindication when angle not surgically opened; ensure open angle per gonioscopy.
Study-based indications and endpoints
Covered when study‑indicated clinical conditions are met (evidence‑based contexts described in the cited studies):
Typical study inclusion/indication logic: Patient has open‑angle glaucoma with uncontrolled IOP despite maximally tolerated medical therapy or prior surgical intervention; eyes with coexisting cataract in many trials underwent combined phacoemulsification plus device implantation.IOP ranges in studies: baseline medicated IOP often 18–33 mmHg; success commonly defined as ≥20% IOP reduction or postoperative IOP thresholds (eg, ≤16–17 mmHg)
Derived from multiple RCTs and prospective studies (iStent, Hydrus, CyPass, XEN).
Evidence summaries relevant to coverage decisions
Summary of trial‑based coverage‑relevant findings
CyPass micro‑stent RCT effectiveness: In RCTs of supraciliary microstent plus cataract surgery for mild‑to‑moderate POAG with baseline unmedicated DIOP 21–33 mmHg, microstent plus phacoemulsification produced greater IOP reduction and higher medication‑free rates at 24 months versus phacoemulsification alone.per RCT inclusion criteria
However, later long‑term endothelial cell loss findings prompted safety concerns for CyPass.
Bimatoprost ocular insert: Phase II RCT showed IOP reductions over 6 months with primary retention ~88.5%, meeting non‑inferiority at limited timepoints but underpowered for full effect assessment.washout IOP >=23 mmHg and <=34 mmHg per trial
Limited duration evidence for broad coverage decisions.
ELT and GATT evidence: Excimer laser trabeculostomy (ELT) and GATT case series/cohorts show moderate IOP lowering and medication reduction with notable procedure‑specific complications (e.g., transient hyphema after GATT); evidence varies in quality and duration.
GATT case‑series inclusion: Adults with uncontrolled open‑angle glaucoma who underwent GATT with at least 6 months of follow‑up.>=6 months follow-up
Retrospective non‑comparative series reporting IOP and medication reductions.
iStent multi‑arm randomized study inclusion: Patients with open‑angle glaucoma with pre‑operative IOP 18–30 mmHg on 1–3 medications and unmedicated (post‑washout) IOP 22–38 mmHg; randomized to 1, 2, or 3 stents with outcomes through 42 months.pre‑op and washout IOP ranges specified
Eligibility reflected in Katz et al. and multi‑arm studies.
iStent Infinite study inclusion: Eyes with open‑angle glaucoma uncontrolled by prior incisional or cilio‑ablative surgeries or maximum tolerated medical therapy; responder endpoint typically ≥20% MDIOP reduction at 12 months.
The policy lists specific procedures, devices and related CPT/HCPCS codes that are considered not covered / experimental or investigational. Examples called out include suprachoroidal device placements (e.g., 0253T, 0474T), insertion of non‑FDA‑approved suprachoroidal or novel shunts (e.g., DeepLight Gold Micro‑Shunt/SOLX and Eyepass), and drug‑eluting anterior segment implants into the lacrimal canaliculus (0660T, 0661T, 68841) which are not supported for glaucoma indications. The document also lists ab interno trabeculectomy and related laser trabeculostomy codes as experimental (0621T, 0622T), and identifies codes for intra‑operative OCT and certain device insertions (for example, standalone iStent Infinite code 0671T and implant HCPCS C1783/L8612) among items flagged as not covered or investigational when performed outside established indications.
The SOLX Gold Micro‑Shunt (SOLX) is identified in the policy as a novel suprachoroidal device considered investigational in the U.S. because available evidence is limited and randomized controlled trials comparing the device to standard filtering procedures are lacking. The AAO technology assessment noted concerns about the device’s permanent anterior‑chamber/suprachoroidal implant and the need for higher‑quality RCT data before effectiveness can be established.
The policy cites specific risks and rationale supporting the investigational status of the SOLX Gold Shunt: it is a permanent implant occupying the anterior chamber and suprachoroidal space with documented concerns for implant erosion or exposure, an incompletely delineated mechanism of action, and a paucity of randomized controlled trial evidence to demonstrate comparative benefit versus trabeculectomy or phacoemulsification alone.
Device labeling and trial enrollment criteria require attention to contraindications for the Hydrus Microstent and XEN Gel Stent. The Hydrus Microstent is not to be used in patients with angle‑closure glaucoma, malignant glaucoma, neovascular glaucoma, traumatic glaucoma, uveitic glaucoma or birth defects of the anterior chamber angle, and its approved use in the U.S. is in conjunction with cataract surgery for adults with mild‑to‑moderate POAG. Providers should confirm these device‑specific exclusions prior to implantation.
The XEN Gel Stent labeling specifically contraindicates use in angle‑closure glaucoma where the angle has not been surgically opened. Other listed contraindications that may preclude device use (and coverage) include prior glaucoma shunt/valve or conjunctival scarring/pathology in the target quadrant, active iris neovascularization, an anterior chamber intraocular lens, intraocular silicone oil, and vitreous in the anterior chamber.
The policy excludes devices that have been withdrawn for safety reasons from consideration for use. Notably, the CyPass supraciliary micro‑stent was withdrawn following long‑term safety signals and is effectively excluded because of demonstrated adverse effects, particularly progressive corneal endothelial cell loss observed on 5‑year follow‑up.
The CyPass Micro‑Stent recall is cited alongside published case reports raising safety concerns. The document references a reported case of bilateral hypertensive crisis after CyPass insertion and summarizes 5‑year post‑approval data indicating increased corneal endothelial cell loss associated with device position in the anterior chamber — findings that prompted device withdrawal and ongoing caution about similar supraciliary implants.
Intra‑operative optical coherence tomography (iOCT) is not established as a standard adjunct in referenced clinical guidance. UpToDate reviews cited in the policy do not mention iOCT as a routine adjunctive option in glaucoma surgery, and therefore the technology is described as not established in prevailing guidelines.
The policy states that adjunctive use of anti‑fibrotic agents or systemic corticosteroids with shunt implants is experimental and investigational except where specifically noted (the Ex‑PRESS mini shunt is an exception for adjunctive antimetabolite use). Use of anti‑fibrotics or systemic steroids with other shunts lacks sufficient evidence and may be considered investigational.
Transciliary filtration (Fugo Blade) is characterized in the policy as having insufficient peer‑reviewed randomized trial evidence to establish effectiveness compared with traditional filtering procedures. The AAO assessment and the policy indicate that randomized controlled trials are needed before transciliary filtration can be considered established therapy.
Laser peripheral iridoplasty in non‑acute angle‑closure situations is noted to lack strong evidence of benefit. A Cochrane review identified only a single randomized trial and found no superiority for iridoplasty as an adjunct to iridotomy for intraocular pressure control, medications or need for surgery in non‑acute settings.
The Cochrane and systematic review evidence summarized in the policy finds that the quality of evidence is often low or uncertain for many combined or novel procedures. For example, combined cataract plus glaucoma surgery may yield better IOP control at 1 year versus cataract alone but the certainty is low and long‑term outcomes, complications, visual field and quality‑of‑life benefits remain uncertain.
The policy cautions against using MIGS procedures (including XEN) as primary substitutes for well‑established long‑term interventions without supportive long‑term data. Current limitations include short follow‑up, mixed study designs, and the common inclusion of cataract surgery in trials — all of which restrict generalizability when considering standalone use of MIGS or XEN outside studied indications.
The document notes that higher‑quality evidence is lacking for some MIGS techniques. Specifically, ab interno trabecular bypass approaches such as the Trabectome have limited high‑quality randomized trial data; the policy states there is insufficient high‑quality evidence to definitively support some of these techniques compared with standard surgery, and calls for adequately powered RCTs to assess long‑term safety and efficacy.
The policy flags drug‑eluting lacrimal canaliculus implants as not part of standard clinical review sources. UpToDate and the policy text do not list insertion of a drug‑eluting implant into the lacrimal canaliculus during routine cataract removal as an established management option for glaucoma, supporting its classification as investigational for this indication.
The policy describes technical limitations of current intra‑operative OCT systems that constrain routine use in glaucoma surgery. Reported limitations include a restricted scanning area, need for frequent repositioning and refocusing, motion artefacts from eye or microscope movement, a learning curve to synchronize the OCT view with the surgical field, and instrument shadowing from metallic instruments — all factors contributing to the technology being considered investigational or evolving.
Coding
Covered CPT/HCPCS codes when selection criteria are metmixedCovered
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).
65855
Trabeculoplasty by laser surgery.
66180
Aqueous shunt to extraocular equatorial plate reservoir, external approach; with graft.
66183
Insertion of anterior segment aqueous drainage device, without extraocular reservoir, external approach.
66185
Revision of aqueous shunt to extraocular equatorial plate reservoir; with graft.
66989
Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage), with insertion of anterior segment aqueous drainage device, internal approach.
66991
Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage), with insertion of anterior segment aqueous drainage device, internal approach.
0253T
Insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, into the suprachoroidal space.
0444T
Initial placement of a drug-eluting ocular insert under one or more eyelids, including fitting, training, and insertion.
1–10 of 20
1/2
Not covered / experimental CPT/HCPCS codesmixedNot Covered
Removal and reimplantation of anterior segment intraocular nonbiodegradable drug-eluting implant (not covered).
68841
Insertion of drug-eluting implant into lacrimal canaliculus (not covered).
0621T
Trabeculostomy ab interno by laser (not covered).
0622T
Trabeculostomy ab interno by laser; with use of ophthalmic endoscope (not covered).
ICD-10 diagnosis codes referencedICD-10
H40.1110-H40.1194
Primary open-angle glaucoma.
H25.011-H26.9
Cataract codes (used with certain device codes).
H40.1311-H40.1394
Pigmentary glaucoma.
Q12.0-Q12.9
Congenital cataract and lens malformations.
H40.20x0-H40.2494
Primary angle-closure glaucoma (codes listed as not covered for some devices).
H40.50x0-H40.53x4
Glaucoma secondary to other eye disorders (not covered for some device indications).
ICD-10 CodesICD-10
H40.10x0 - H40.159
Open-angle glaucoma
No CPT/HCPCS/ICD codes listed in this excerptmixed
No codes listed
Proportion POAG — key metric
Proportion of glaucoma that is primary open‑angle glaucoma (POAG)About 90% of patients with glaucoma have POAG.
POAG characterizationChronic condition with gonioscopically open angle, decreased outflow facility, and slow progressive optic neuropathy.
Clinical implicationsPOAG is the most common form of glaucoma and is typically managed initially with medical therapy; surgery considered when medications/laser fail.
Study follow‑up thresholds — key durations
Minimum follow-up used in several studiesStudies and case series commonly report at least 6 months minimum follow-up for inclusion.
Provider Actions and Documentation
Prior Authorization
Confirm device‑specific indication and prior therapy
Prior authorization is recommended to confirm device-specific indication, prior therapies, and alignment with plan coverage when devices are used outside FDA-cleared contexts or for refractory disease. Document prior maximal tolerated medical therapy, prior laser procedures, prior incisional glaucoma surgery status, and any device-specific contraindications in the authorization request.
Confirm whether device is being used in conjunction with cataract surgery (many MIGS indications require concurrent cataract surgery).
For devices cleared only in specific settings (eg, iStent, Hydrus with phacoemulsification), include documentation showing the patient meets the device-specific indication.
When devices are requested as standalone procedures after failed prior surgery or on maximum tolerated medical therapy, include prior surgical history and medication regimen.
Prior Authorization
Prior authorization suggested for drug‑eluting ocular inserts
Insertion of drug‑eluting ocular inserts into the lacrimal canaliculus (implantation, removal, or reimplantation) is listed as not covered/experimental in the CPB. Prior authorization should be sought when such codes are submitted and plan coverage is uncertain; include study results and rationale if requesting exception.
Background
Glaucoma is a progressive optic neuropathy often associated with elevated intraocular pressure (IOP); primary open‑angle glaucoma (POAG) is the most common form and accounts for the majority of cases. Management typically begins with topical medical therapy and laser trabeculoplasty, with surgical options considered when those measures fail. This policy provides coverage guidance across this spectrum of interventions.
Definitions
Primary open‑angle glaucoma (POAG) definition
DefinitionPrimary open‑angle glaucoma (POAG): a chronic condition with elevated IOP beyond a level compatible with eye health, gonioscopically open angle, and decreased outflow facility.
Clinical featuresSlow, progressive, insidious optic neuropathy leading to peripheral vision loss.
Management contextMedications are the most common early treatment; surgical options considered when medical therapy fails.
Acute angle‑closure glaucoma (AACG) — definition and relevance
DefinitionAcute angle‑closure glaucoma (AACG): sudden closure of the entire angle, presenting with blurred vision, halos, pain, redness, and often systemic symptoms (eg, nausea/vomiting); IOP can rise precipitously (>50 mm Hg).
Differentiation from POAG
Revision History
2001-06-08effective_date
Policy became effective.
2023-03-24last_reviewLatest
Policy last reviewed on this date as documented in the policy history.
2024-05-09next_scheduled_review
Next scheduled policy review date.
Policy Summary
PayerAetna
PolicyGlaucoma Surgery
Policy CodePolicy 0484
Change TypeNo material change
Effective DateJun 8, 2001
Next Review DateMay 9, 2024
Key ActionObtain and document prior therapies and clinical measures (baseline IOP, prior medication/surgery) to support medical necessity for glaucoma implants.
CyPass and related suprachoroidal devices: CyPass Micro‑Stent and iStent G3 Supra are considered investigational or excluded due to safety concerns/withdrawal; use is not medically necessary.safety concerns/device withdrawn
Drug‑eluting lacrimal and canalicular implants: Insertion of a drug‑eluting implant into the lacrimal canaliculus (including punctal dilation and removal) for glaucoma treatment is investigational.not approved for glaucoma
Other investigational procedures/devices: Beta radiation for glaucoma, ab interno trabeculectomy (Trabectome), ab interno Kahook Dual Blade for primary congenital glaucoma, sub‑conjunctival anti‑VEGF injections for wound control, intra‑operative OCT in glaucoma surgery, excimer laser trabeculostomy/trabeculotomy, and standalone iStent Infinite are investigational.effectiveness not established
List not all‑inclusive.
Considered when indicated by patient anatomy and disease severity; Ex‑PRESS shows similar IOP lowering to trabeculectomy with fewer early hypotony events; ab interno trabeculectomy (Trabectome) has variable success compared with trabeculectomy.
case‑by‑case selection based on risk/benefit
Evidence varies by device and follow‑up interval.
Transciliary filtration/novel devices: Generally considered investigational until robust RCT evidence is available; not positioned as routine options in surgical sequencing.insufficient evidence
AAO assessments recommend RCTs for novel devices.
Prospective and retrospective studies in refractory populations report substantial IOP reductions and medication decreases; pivotal U.S. trial supported FDA clearance for refractory glaucoma.
12‑ to 24‑month outcomes commonly reported
Grover, Reitsamer, Hengerer and pivotal trial data document response rates and needling/complication profiles.
CyPass evidence and safety note: RCT data showed greater IOP reduction and higher medication‑free rates at 24 months for supraciliary microstent plus cataract versus cataract alone, but long‑term endothelial cell loss prompted safety concerns and device withdrawal.24‑month RCT outcomes; long‑term safety signal
Performance at 24 months was favorable but later 5‑year ECL signal affected device status.
Drug‑eluting ocular inserts: Phase II RCT evidence (bimatoprost insert) demonstrated IOP reduction over 6 months with primary retention ~88.5%, but non‑inferiority achieved only at limited timepoints and the study was underpowered for some outcomes.6‑month RCT data
Limited duration and scope of evidence; not yet definitive for broad coverage.
Contraindications and anatomic suitability excluded: Device‑specific contraindications must be absent (Hydrus: angle‑closure, malignant, neovascular, traumatic, uveitic, congenital angle defects; XEN: angle‑closure without surgical opening, prior conjunctival scarring in target quadrant, active iris neovascularization, anterior chamber IOL, intraocular silicone oil, vitreous in anterior chamber).none
Confirm anatomic suitability and absence of listed contraindications per device labeling.
Expected benefit based on evidence: Clinical trial evidence demonstrates higher proportions achieving ≥20% unmedicated IOP reduction and reduced medication use with Hydrus or iStent plus cataract surgery versus cataract alone; coverage favors cases where similar benefit is likely based on patient selection.≥20% IOP reduction endpoint referenced
Evidence supports device use in populations mirroring trial inclusion criteria.
varies by study
These findings inform but do not by themselves establish coverage beyond studied indications.
responder endpoint: >=20% MDIOP reduction at 12 months
Randomized trials for devices (eg, Hydrus, iStent, CyPass) commonly report outcomes at 24 months (2 years).
Longer-term follow-upSome studies and pooled analyses report outcomes at 36–60 months (3–5 years) for iStent and multi‑stent series.
iStent infinite trial endpoint timingiStent infinite responder endpoint reported at 12 months (MDIOP reduction) with supporting data through 12 months in single‑arm study.
Codes 0660T, 0661T, 68841 are listed as not covered / experimental for this CPB.
Provide clinical justification, trial data, and prior therapy history if requesting coverage for investigational drug‑eluting inserts.
Note
Prior authorization — not specified in excerpt
Some interventions or devices in the source text do not carry an explicit prior‑authorization requirement within this excerpt. When prior‑auth rules are not specified, follow standard plan administrative processes and submit complete clinical documentation to support medical necessity.
Absence of an explicit prior authorization statement in the CPB does not imply universal coverage; confirm with payer-specific prior authorization pathways.
Attach full clinical records (diagnoses, prior treatments, operative reports) when submitting claims for devices without explicit prior‑auth language.
Prior Authorization
Appropriate use context for aqueous shunts
Aqueous shunt implants are generally reserved for eyes that have failed medical therapy, laser trabeculoplasty, and/or prior filtering surgery, or for complex/refractory glaucomas. Authorization requests should describe the clinical context showing inadequate response to less invasive therapies.
Document prior maximal tolerated medical therapy and prior laser (eg, selective or argon trabeculoplasty) attempts.
For post‑trabeculectomy failures or eyes with extensive conjunctival scarring, note prior surgical details and why conventional filtering surgery is not suitable.
Examples of standard aqueous shunts: Ahmed, Baerveldt, Krupin, Molteno, Schocket, glaucoma pressure regulator.
Note
Risk note on adjuncts
Adjunctive agents (eg, mitomycin‑C, beta irradiation) have device‑ and procedure‑specific risk profiles. Note that some adjuncts (e.g., beta irradiation) increase cataract risk and adjunctive use with certain shunts lacks evidence of benefit; document rationale when adjuncts are used.
Adjunctive mitomycin‑C is supported for some procedures (eg, trabeculectomy) but evidence does not show benefits for many shunts; include literature support if requesting coverage of adjunctive use.
Beta irradiation was associated with increased cataract risk; list this as an AE risk in the authorization.
Adjunctive systemic corticosteroids with shunts are considered investigational per the CPB; provide justification if used.
Several implants are contraindicated in specific glaucoma types or anatomic situations. Confirm and document absence of listed contraindications before requesting device placement; presence of contraindications may preclude coverage.
iStent contraindications include primary or secondary angle‑closure glaucoma, Sturge‑Weber syndrome, elevated episcleral venous pressure, retrobulbar tumor, thyroid eye disease, and neovascular glaucoma.
Hydrus contraindications include angle‑closure glaucoma, malignant glaucoma, neovascular glaucoma, traumatic glaucoma, uveitic glaucoma, and birth defects of the anterior chamber angle.
XEN contraindications include angle‑closure without prior surgical opening, prior glaucoma shunt/valve or conjunctival scarring in the target quadrant, active iris neovascularization, anterior chamber silicone oil, and vitreous in the anterior chamber.
Denial Risk
Contraindications may preclude coverage
When a device is contraindicated for a patient (per product labeling or CPB), coverage may be denied. Explicitly document contraindications and, if proceeding, include rationale and any mitigating steps; consider alternative treatments.
Requests for devices in the presence of listed contraindications should include detailed clinical justification and may be subject to denial.
Note CPB lists specific device limits (eg, >2 iStents/eye or >1 Hydrus/eye) as investigational — requests exceeding these limits have high denial risk.
If device use is proposed despite contraindication, provide specialty consultant opinion and risk/benefit discussion.
Prior Authorization
Safety‑triggered restriction
Long‑term safety signals for specific devices have led to restrictions or market withdrawal; document device model and any relevant post‑market safety data in authorization requests and monitor for safety‑driven coverage changes.
CyPass experienced long‑term endothelial cell loss and has been withdrawn; requests involving withdrawn devices should be denied and alternative therapies pursued.
If post‑market surveillance identifies device‑specific harms, prior authorization decisions may be updated to reflect safety concerns.
Provide corneal endothelial cell counts and follow‑up data when safety concerns (eg, ECL) are relevant to the requested procedure.
Note
Not specified in this excerpt; no procedure‑level prior‑auth language
The excerpt does not specify prior authorization requirements for some procedures or devices (administrative note). Providers should follow the payer’s current prior authorization portal or contact the plan for specific requirements.
When in doubt, submit a pre‑service prior authorization with complete clinical records.
Clinical Policy Bulletins summarize coverage guidance but do not replace payer authorization rules — verify via plan channels.
Note
Clinical Policy Bulletins do not constitute coverage guarantees
Clinical Policy Bulletins (CPBs) provide plan‑level guidance but do not by themselves constitute coverage guarantees. Providers remain responsible for verifying benefit design and obtaining any required authorizations.
CPBs are informational and administrative; coverage is governed by the member’s contract and plan authorization processes.
Always confirm member benefits, prior authorization requirements, and post‑service claim rules before performing procedures.
Billing Rule
Coding / documentation linkage
Billing must align with device selection criteria, concurrent cataract surgery bundling rules, and the clinical documentation supporting medical necessity. Ensure submitted CPT/HCPCS and ICD‑10 codes match the documented procedure and indication.
For MIGS performed with cataract surgery, use the cataract + device CPT codes (eg, 66989, 66991) where applicable and document that the device indication requiring combined surgery is met.
Include ICD‑10 glaucoma diagnosis codes (eg, H40.1110‑H40.1194 for POAG) that support the medical necessity for the procedure.
When submitting 0449T/0450T or 66183, ensure operative report describes device type, laterality, number of devices, and approach.
Documentation Required
Post‑operative documentation examples from iStent case series
Post‑operative case-series of iStent report standardized follow‑up measures that are useful to include in authorization and outcome documentation: IOP (Goldmann tonometry), number of glaucoma medications, visual acuity, and device‑related complications.
Include baseline and post‑operative IOP measurements at standard timepoints (eg, 1 day, 1 week, 1 month, 3, 6, 12 months).
Report number of glaucoma medications at baseline and follow‑up visits and any medication washout data if performed.
Document any device lumen obstruction, hyphema, transient IOP spikes, or need for secondary glaucoma surgery.
Documentation Required
Required clinical documentation for micro‑stent cases
For micro‑stent cases (eg, iStent, Hydrus, XEN), include required clinical details in prior authorization and medical records: baseline modified diurnal IOP (MDIOP) or DIOP when available, prior medication regimen and washout status, prior incisional glaucoma surgeries, and procedural details (device model, number, laterality, concurrent cataract surgery).
Report washed‑out MDIOP/DIOP values when trials used washout measurements (specify washout protocol).
Provide prior medication counts, names, and evidence of maximal tolerated therapy if claiming refractory disease.
State device model, number of stents implanted, and whether the procedure was standalone or combined with cataract surgery.
Clinical studies commonly define effectiveness endpoints (eg, ≥20 % MDIOP reduction unmedicated, reduction in medication use, proportion medication‑free) and follow specified timepoints. When requesting authorization or reporting outcomes, align documentation to these endpoints where relevant.
Include the study‑style responder endpoints (eg, % eyes achieving ≥20 % unmedicated MDIOP reduction at 12 or 24 months) if claiming comparative effectiveness.
Provide follow‑up data at the trial timepoints (eg, 12 and 24 months) when available, and state whether outcomes are qualified (with medications) or complete (off medications).
Note
Surgical sequencing considerations when cataract co‑exists with glaucoma
When cataract co‑exists with glaucoma, surgical sequencing affects outcomes. Document rationale for combined versus staged procedures and prior cataract impact on bleb function when applicable.
If combining MIGS with phacoemulsification, document cataract severity and anticipated benefit from a combined approach.
Note that phacoemulsification can alter IOP and affect prior trabeculectomy bleb function; include prior bleb status if relevant.
For eyes with visually significant cataract and uncontrolled glaucoma despite maximal therapy, combined glaucoma and cataract surgery may be medically necessary.
Documentation Required
Consideration of prior medical / laser therapy — document maximal tolerated therapy
Prior medical or laser therapy should be documented before approving device implantation for most indications. Record prior use and failure of topical medications and laser trabeculoplasty as evidence of inadequate control.
Document trials of first‑line and second‑line ocular hypotensives and response, including adherence concerns or intolerance.
Include prior laser trabeculoplasty details (type, date, outcome) when relevant to the request.
State whether the patient is on maximum tolerated medical therapy and describe limitations leading to surgical consideration.
Prior Authorization
Surgery after medical / laser therapy failure
Surgery (MIGS, XEN, aqueous shunts) is generally considered after failure of medical and/or laser therapy. Authorization requests should describe the sequence of prior treatments and objective evidence of insufficient control.
For refractory glaucoma or failed prior filtering surgery, include prior operative reports and outcomes.
For XEN and other stents used in refractory settings, document prior needling, mitomycin use, and reason for current intervention.
When submitting for MIGS after failed medical therapy, include medication counts, IOP trends, and visual field progression if available.
Note
Clinical studies describe use of iStent — use study endpoints in documentation
Clinical studies describe iStent use primarily in combination with cataract surgery for mild‑to‑moderate OAG, report reductions in IOP and medication burden, and note common post‑op findings (eg, hyphema, transient IOP spikes, lumen obstruction). Use these published endpoints to support coverage when the patient matches studied populations.
iStent was FDA‑approved for use with cataract surgery in adults with mild‑to‑moderate OAG on medication.
Provide trial‑aligned baseline IOP, medication counts, and follow‑up measurements when asserting expected benefit.
Report any device‑specific AEs observed in the patient's course (eg, hyphema, obstruction) in follow‑up documentation.
AACG is acute and symptomatic, unlike the typically asymptomatic, slowly progressive POAG.
Procedural relevanceIridotomy, iridectomy, or iridoplasty may be necessary treatments for AACG when indicated.
Definition (duplicate)Primary open‑angle glaucoma (POAG): chronic optic neuropathy with gonioscopically open angle and decreased outflow facility, often associated with elevated IOP.
Prevalence noteRepresents about 90% of glaucoma cases.
Clinical courseSlow, progressive disease often initially managed with topical/systemic hypotensive medications.
Aqueous drainage device / shunt definition
DefinitionAqueous drainage device / shunt: implantable device (valved or nonvalved) that shunts aqueous humor from the anterior chamber to a subconjunctival reservoir or extraocular plate to lower IOP.
ExamplesFDA‑approved standard devices include Ahmed valve, Baerveldt seton, Schocket shunt, Krupin‑Denver valve, Molteno implant, Glaucoma pressure regulator.
Typical designSilicone tube with external plate forming a fibrous capsule reservoir at the equator of the globe.
Ex‑PRESS mini glaucoma shunt definition
DefinitionEx‑PRESS mini glaucoma shunt: a single‑piece stainless‑steel translimbal implant (≈400 microns diameter, <3 mm length) placed under a scleral flap to divert aqueous to a subconjunctival bleb.
Insertion approachPlaced via an external approach in a superficial scleral flap through the trabeculum into the anterior chamber.
Effectiveness evidenceMulticenter study reported 69% success at 1 year (IOP <21 mm Hg without medications) with 30–40% IOP reduction.
Trabectome (ab interno trabeculectomy) definition
DefinitionTrabectome (ab interno trabeculectomy): procedure that ablates a strip of trabecular meshwork/inner wall of Schlemm's canal via an internal approach to improve aqueous outflow without creating an external bleb.
Outcomes summaryMeta-analyses report significant IOP and medication reductions with low rates of visually threatening complications; variable success compared to trabeculectomy.
Typical IOP changeReported mean IOP decreases approximating 27–39% in combined or standalone cases, with variable 2‑year success rates.
Transciliary filtration (Fugo Blade) definition
DefinitionTransciliary filtration (Fugo Blade): thermo‑cautery–based creation of a filter track through the ciliary body (posterior drainage) using a plasma/Fugo Blade device to allow aqueous egress from the posterior chamber.
Regulatory/clearance noteFugo Blade received FDA 510(k) clearance for sclerostomy but lacks PMA-level efficacy data; literature limited to case series.
Evidence statusInsufficient peer‑reviewed randomized controlled trial evidence to establish effectiveness compared with conventional filtering techniques.
iStent (trabecular bypass device) definition
DefinitioniStent (trabecular bypass device): a small heparin‑coated titanium implant placed into Schlemm's canal to restore fluid drainage and reduce IOP, commonly used in combination with cataract surgery.
Intended useDesigned to increase trabecular outflow and decrease IOP when implanted at time of phacoemulsification in adults with mild‑to‑moderate OAG on medication.
Evidence noteRandomized and nonrandomized studies demonstrate added IOP reduction and medication burden decrease versus cataract surgery alone, with follow‑up up to several years.
CyPass Micro‑Stent / iStent G3 Supra definition
DefinitionCyPass Micro‑Stent / iStent G3 Supra: small drainage devices inserted to connect the anterior chamber to the suprachoroidal space to increase uveoscleral outflow, intended for use alone or with cataract surgery.
Design noteInserted ab interno under gonioscopic view through a clear corneal incision into the suprachoroidal space.
Safety noteCyPass showed IOP and medication benefits at 24 months in RCTs but later long‑term endothelial cell loss led to device withdrawal/concern.
Iridotomy / Iridectomy / Iridoplasty definitions
IridotomyLaser procedure using a laser to create an opening in the iris (often used in angle‑closure glaucoma).
IridectomySurgical removal of part of the iris; used in angle‑closure management when indicated.
IridoplastyLaser shrinking of peripheral iris tissue (gonioplasty) to widen the angle; used in selected angle‑closure scenarios.
Washed‑out DIOP / MDIOP definition
Washed‑out DIOP / MDIOP definitionWashed‑out diurnal intraocular pressure (DIOP) or modified DIOP (MDIOP): IOP measured after cessation (washout) of hypotensive medications used as baseline and trial endpoint assessments.
Typical trial rangesPivotal trials enrolled eyes with washed‑out DIOP/MDIOP in ranges such as 21–36 mmHg or 22–34 mmHg.
Use in endpointsResponse often defined as ≥20% decrease in washed‑out DIOP/MDIOP at specified follow‑up times (eg, 12 or 24 months).
MIGS — definition and examples
MIGS definitionMicro‑invasive glaucoma surgery (MIGS): procedures designed to reduce IOP with minimal tissue disruption, medication‑sparing and conjunctival‑sparing ab‑internal approaches.
ExamplesIncludes devices/procedures such as iStent, Hydrus, Trabectome, ELT, GATT, XEN, CyPass, and ab interno canaloplasty.
Clinical roleAimed at lowering IOP and medication burden with favorable safety compared with traditional filtering surgery, typically for mild‑to‑moderate OAG.
Refractory glaucoma (study context) definition
Definition (study context)Refractory glaucoma (study context): glaucoma uncontrolled on maximum‑tolerated medical therapy or after prior filtering/cilio‑ablative procedures; many studies enrolled eyes with medicated IOP ≥20 and ≤35 mmHg.
Typical enrollmentStudies of refractory devices (eg, XEN) enrolled patients with medicated IOP 20–35 mmHg and often visual field constraints (eg, MD ≤ -3 dB).
Implication for device useDevices cleared for refractory glaucoma are intended for eyes failing medical therapy and/or prior surgeries, consistent with trial populations.
Complete success / Qualified success definitions
Complete successOften defined as postoperative IOP within a target range (eg, 6–17 mmHg) without glaucoma medications.
Qualified successSimilar IOP target achieved with the use of topical glaucoma medications (i.e., medications allowed).
Clinical trial usageStudies report complete/qualified success at defined timepoints (eg, 12, 24 months) as primary or secondary outcomes.
Clinical success (trial definition)
Clinical success (trial definition)Clinical success in some trials defined as ≥20% IOP reduction from baseline on the same or fewer medications without secondary glaucoma surgery.
Common endpoint timingPrimary endpoints for Hydrus and iStent trials were frequently assessed at 24 months (eg, proportion achieving ≥20% MDIOP reduction).
Responder criteriaResponder endpoints often require documented washout MDIOP/DIOP measurements and medication counts to determine ≥20% reduction.
Excimer laser trabeculostomy (ELT) definition
DefinitionExcimer laser trabeculostomy (ELT): a minimally invasive photo‑ablative laser procedure creating channels through the trabecular meshwork to increase aqueous outflow and lower IOP.
Evidence summaryStudies report moderate IOP lowering (20–40%) and reduced medication use with favorable safety in small RCTs and case series.
Clinical roleConsidered a MIGS approach among other trabecular outflow enhancing procedures.
GATT definition
DefinitionGonioscopy‑assisted transluminal trabeculotomy (GATT): an ab interno circumferential (360°) trabeculotomy performed via gonioscopy to improve aqueous outflow.
OutcomesCase series report substantial IOP and medication reductions with transient hyphema a common early complication (≈30% at 1 week in some series).
Follow‑up>=6 months follow‑up commonly reported in series evaluating GATT outcomes.
GATT — duplicate definition preserved
Definition (duplicate preserved)Gonioscopy‑Assisted Transluminal Trabeculotomy (GATT): minimally invasive ab interno circumferential 360° trabeculotomy for open‑angle glaucoma.
Evidence noteReported series include adults with uncontrolled OAG and at least 6 months follow‑up showing IOP and medication reductions.
Complication profileTransient hyphema is common early post‑op; reoperation rates vary by series.
iOCT definition
DefinitionIntra‑operative OCT (iOCT): spectral‑domain OCT integrated with the surgical microscope to provide real‑time cross‑sectional imaging during ocular surgery.
Technical limitationsCurrent limitations include instrument shadowing and restricted scanning area; further studies and device modifications are needed.
Evidence statusPilot studies demonstrate feasibility and potential to guide surgical steps, but routine use in glaucoma surgery is not established in guidelines.
iStent infinite definition
DefinitioniStent infinite: a trabecular micro‑bypass system consisting of three iStent inject W stents intended for standalone implantation to lower IOP in OAG uncontrolled by prior surgeries or maximal medical therapy.
Intended populationStudied in eyes uncontrolled by prior incisional or cilio‑ablative surgeries or maximum tolerated medical therapy; responder endpoint ≥20% MDIOP reduction at 12 months.
Study outcomesProspective multi‑center data reported responder rates of ~76% at 12 months and favorable safety without device explants or hypotony in 72‑eye series.
Effective Date: 06/08/2001; Last Review: 03/24/2023; Next Scheduled Review: 05/09/2024.