ModifiedUnitedHealthcarePolicy CS050OH.D

Glaucoma Surgical Treatments (for Ohio Only)

Clinical coverage for surgical and laser treatments for glaucoma for UnitedHealthcare members in Ohio; defines which procedures are considered proven/medically necessary and references pediatric criteria and related policies.

Policy Summary

PayerUnitedHealthcare

PolicyGlaucoma Surgical Treatments (for Ohio Only)

Policy CodePolicy CS050OH.D

Change TypeOperative/coding update (CPT 1012T added)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, prior treatments, baseline IOP and rationale when requesting MIGS or less-established procedures.

SourceLink

POLICY UPDATE CHANGES

Added CPT code 1012T to the applicable codes list.

Archived previous policy version CS050OH.C.

Updated Supporting Information section.

OhioApplies to

≥19Adults threshold

20% IOPMIGS benchmark

1New CPT added

629

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Coverage Criteria for Glaucoma Procedures

Proven when combined with cataract surgery

Covered when used in adults (age 19 years or more) in combination with cataract surgery for mild to moderate OAG and while on ocular hypotensive medication:

MIGS/canaloplasty/trabeculotomy with cataract: Goniotomy, trabeculotomy, canaloplasty (ab interno), or combined canaloplasty (ab interno) and trabeculotomy (e.g., OMNI Surgical System, Streamline Surgical System) are proven and medically necessary when performed in adults (age >=19 years) in combination with cataract surgery for treatment of mild to moderate open‑angle glaucoma in patients currently being treated with ocular hypotensive medication.age >=19

Policy proven list; see chunk 4

Trabecular microstent with cataract: Trabecular micro‑bypass stents (iStent, iStent inject) and Schlemm's canal microstents (Hydrus Microstent) are proven and medically necessary when implanted at the time of cataract surgery for treatment of mild to moderate open‑angle glaucoma in adults currently being treated with ocular hypotensive medication.age >=19

Policy proven list; see chunk 4

Refractory glaucoma

Covered for refractory glaucoma when prior medical or surgical treatments have failed or are inappropriate:

Glaucoma drainage devices for refractory glaucoma: Certain glaucoma drainage devices (for example: XEN System, EX‑PRESS, Molteno implant, Baerveldt tube shunt, Ahmed glaucoma valve implant, Krupin‑Denver valve) are proven and medically necessary for management of refractory glaucoma when medical therapy and/or prior surgical treatments have failed or are inappropriate.refractory after failure of medical/surgical therapy or inappropriate alternative

Policy statement and device-specific evidence; see chunks 4 and 54

MIGS coverage considerations

MIGS expectations and candidate selection considerations:

Intended MIGS population: MIGS procedures are typically indicated for adults with mild to moderate open‑angle glaucoma and are commonly performed concurrently with phacoemulsification; they are generally not suitable for advanced disease requiring very low target IOPs.clinical judgment

MIGS candidate guidance; see chunk 15

Effectiveness benchmark for MIGS: To be considered effective, a MIGS procedure should provide at least a 20% reduction in intraocular pressure or reduce glaucoma therapy by at least one medication.>=20% IOP reduction or >=1 medication reduction

Performance benchmark stated for MIGS; see chunk 15

Safety vs traditional surgery: MIGS typically have a more favorable short‑term safety profile but more modest IOP lowering compared with trabeculectomy or aqueous shunt surgery; procedural selection should reflect the balance of safety, expected IOP reduction, and patient goals.

Laser procedures

Laser procedure coverage stance and distinctions:

Proven/covered laser procedures: Laser iridotomy/iridectomy (e.g., Nd:YAG), laser iridoplasty, and laser ciliary body destruction (cyclophotocoagulation) are considered proven and medically necessary when used for accepted indications (e.g., LPI for PACS/PAC, CPC for selected refractory cases, SLT for OAG/OHT as clinically appropriate).

Policy lists proven laser types and supporting trials (LPI, SLT, CPC); see chunks 4, 55, 56, 60

Other laser procedures unproven: Other laser procedures (e.g., excimer laser trabeculostomy ELT, femtosecond laser trabeculotomy FLT, OCT‑guided trabeculotomy, FLIGHT) lack sufficient high‑quality evidence and/or are not FDA‑approved for glaucoma in the US and therefore are unproven and not medically necessary without strong supporting rationale and documentation.

Policy statement on unproven lasers and evidence limitations; see chunks 4 and 104-106

Covered with clinical evidence

Summary of devices/procedures supported by clinical evidence (evidence descriptions do not create additional prescriptive gating criteria beyond those above):

Pediatric angle surgery evidence note: Comparative and cohort studies of pediatric goniotomy, trabeculotomy, and combined procedures show variable long‑term success; microcatheter‑assisted 360° trabeculotomy may offer greater benefit but with more adverse effects—evidence is limited by small trials and follow‑up.

Pediatric evidence summaries; see chunks 18-20

iStent family evidence note: Randomized and nonrandomized studies of iStent and iStent inject implanted with cataract surgery demonstrate modest additional IOP and medication reductions versus phaco alone; second‑generation devices (iStent inject) show improved effects in pivotal trials.

Systematic reviews and RCTs summarized; see chunks 23, 24, 26

Hydrus Microstent evidence note: RCT evidence (HORIZON) and longer‑term follow‑up indicate Hydrus combined with cataract surgery increases medication‑free rates and achieves greater IOP lowering versus cataract surgery alone with acceptable safety up to 5 years in trials.

Evidence summaries by device/procedure

Device- and procedure-level evidence synopsis (informing coverage stance and documentation expectations):

Hydrus evidence synopsis: Prospective and retrospective studies report IOP and medication reduction after Hydrus implantation; comparative RCT data support superiority to phaco alone for medication‑free status in many patients.

See Hydrus HORIZON and ECRI analyses; chunk 33-36

EX‑PRESS evidence synopsis: Meta‑analysis of RCTs indicates EX‑PRESS implantation provides similar or improved IOP control and higher complete success rates vs trabeculectomy with fewer IOP spikes and hyphema in some studies.

See EX‑PRESS meta‑analysis; chunk 38

Aqueous tube shunts evidence synopsis: Systematic reviews and RCTs report mixed comparative results versus trabeculectomy across Ahmed, Baerveldt, and Molteno implants, with differing profiles for IOP reduction and adverse events; device selection should reflect the refractory indication and patient risk profile.

See tube shunt meta‑analysis and Budenz RCT; chunks 42 and 46

Intervention-specific evidence summaries

Intervention-specific evidence notes and typical clinical contexts where interventions were evaluated:

XEN 45 in refractory glaucoma: XEN 45 was studied primarily in refractory glaucoma (prior filtering/cilioablative failure or uncontrolled IOP on maximally tolerated therapy) and showed IOP and medication reductions in single‑arm series; absence of comparators limits strength of evidence.

Grover prospective series and systematic reviews; see chunks 54, 47, 51

SLT as initial/adjunctive therapy: Randomized evidence (LIGHT trial) supports SLT as an effective initial or adjunctive therapy for POAG/OHT with durable control and reduced progression versus drops.

LIGHT trial; see chunk 55

Laser peripheral iridotomy (LPI): Prophylactic LPI reduced progression to primary angle closure end‑points in PACS over 5 years and is supported for indicated patients.

Baskaran RCT for PACS; see chunk 56

Typical study-based eligibility

Study eligibility characteristics commonly used in the literature (may inform typical coverage considerations):

Typical study inclusion features: Most controlled and observational studies enroll adults with mild to moderate open‑angle glaucoma, often with visually significant cataract when combined with phaco; baseline IOPs reported up to approximately 33 mmHg and participants commonly are on 1–4 topical hypotensive medications.IOP <= ~33 mmHg in many trials; 1–4 medications typical

Derived from multiple study inclusion summaries; see chunks 74, 76, 81, 91

Evidence-based coverage context

Evidence strength, limitations, and guideline context informing coverage decisions:

Evidence limitations and implications: Many MIGS and goniotomy/trabeculotomy studies are small, nonrandomized, single‑center, or have short follow‑up; these limitations support conditional coverage tied to appropriate indications, documentation of baseline IOP and goals, and use consistent with published trial populations.

Evidence limitations summarized in policy and systematic reviews; see chunks 90, 96, 93

Guideline alignment: AAO guidance notes MIGS typically produce modest IOP reductions with favorable short‑term safety; Hydrus is FDA‑approved for use with phaco in mild‑moderate POAG and AAO/NICE assessments support selective use of trabecular stents—coverage should align with device indications and guideline recommendations.

AAO and NICE guidance referenced; see chunks 101-103

Guideline context

Guideline and regulatory context relevant to procedure selection and coverage:

AAO guidance implications: AAO states MIGS have more favorable short‑term safety but more modest IOP lowering than trabeculectomy or aqueous shunts; device‑specific approvals (e.g., Hydrus for use with phaco) and guideline recommendations should inform coverage decisions and procedural selection.

AAO Preferred Practice Patterns and technology assessments; see chunks 101-102

NICE and other assessments: NICE concluded trabecular stent bypass microsurgery is safe and effective based on pooled evidence; such assessments provide supporting context but do not by themselves determine coverage under plan or state rules.

NICE guidance summary; see chunk 103

Limited-evidence laser procedures

Procedures with limited or insufficient evidence (coverage requires strong justification and likely prior authorization):

Other laser procedures lacking robust evidence: ELT, FLT, OCT‑guided trabeculotomy, FLIGHT, and similar laser‑based trabecular procedures have limited quality evidence, often single‑arm or small studies, and some are not FDA‑approved for glaucoma in the U.S.; these are considered limited‑evidence procedures and require supporting clinical rationale and documentation if requested.

Policy notes limited evidence and lack of FDA approval in US for several laser techniques; see chunks 104-106

Standalone less‑evaluated MIGS: Standalone KDB trabeculectomy and other less‑evaluated MIGS/laser procedures lack sufficient comparative effectiveness and long‑term data; absent robust evidence these uses may be considered investigational or require additional justification.

Policy and evidence reviews flag limited data for standalone KDB and similar; see chunks 96 and 107

Coverage decision workflow

Operational workflow for coverage decisions and prior authorization expectations:

Use InterQual as primary criteria: Coverage determinations should apply InterQual medical/surgical criteria for glaucoma procedures; when InterQual lacks applicable criteria, use UnitedHealthcare medical policies, Coverage Determination Guidelines, and/or Utilization Review Guidelines as approved by Ohio Medicaid Services.

Policy instruction on criteria sources; see chunk 131

Prior authorization documentation expectations: Prior authorization requests for MIGS, novel devices, refractory device implantation, or less‑established laser procedures should include: diagnosis subtype, baseline IOP (Goldmann applanation), number/type of glaucoma medications, prior medical and surgical treatments and responses, surgical intent (IOP lowering vs medication reduction), and device‑specific rationale referencing comparative evidence or lack thereof.

Prior auth and documentation guidance derived from policy recommendations; see chunks 26, 42, 46, 55, 73

Refractory pathway and step consideration: For refractory glaucoma interventions (e.g., aqueous shunts, XEN in refractory contexts), document prior failure of medical and/or surgical therapy; consider less invasive options (e.g., SLT) when clinically appropriate prior to escalation per clinical judgment and guideline recommendations.

The policy explicitly states that all laser procedures not specifically listed as proven (beyond laser iridotomy/iridectomy, iridoplasty, and laser ciliary body destruction) are considered unproven and not medically necessary for treating any type of glaucoma due to insufficient evidence of efficacy and/or safety.

The evidence base does not clearly support standalone implantation of iStent devices outside the context of cataract surgery. Systematic reviews and meta-analyses show modest IOP and medication reductions after iStent implantation, but most favorable and strongest evidence is for iStent or iStent inject when performed in combination with cataract surgery; standalone use lacks the same level of randomized comparative evidence and therefore may not be supported without an appropriate documented indication.

For several glaucoma drainage and tube shunt devices, the document does not list blanket exclusions but notes limitations in comparative evidence. For example, meta-analyses and systematic reviews report mixed comparative outcomes versus trabeculectomy for devices such as Baerveldt, Ahmed, EX-PRESS, and XEN; some devices show differing IOP results and adverse-event profiles, and lack of RCT data for devices like XEN limits strength of conclusions.

Cyclodestructive procedures (ciliary body destruction techniques) are not specifically excluded in the excerpts, but a Cochrane review found the evidence inconclusive comparing these procedures with other glaucoma treatments; reported adverse events (e.g., hypotony, phthisis bulbi) and limited trial data suggest clinical use is generally reserved for refractory cases and requires careful justification.

Studies in severe or refractory glaucoma were often excluded or limited and report variable outcomes. Case series of KDB in severe/refractory eyes show reduced efficacy over time and lower proportions achieving ≥20% IOP reduction; nonrandomized designs, small samples, and short follow-up limit generalizability and suggest decreased effectiveness in more advanced disease in some reports.

The policy identifies several laser procedures that are not FDA-approved for glaucoma in the U.S. (for example, excimer laser trabeculostomy, femtosecond laser trabeculotomy, and OCT-guided laser trabeculotomy) and notes insufficient peer-reviewed evidence to establish safety and effectiveness for glaucoma indications.

The document emphasizes that FDA approval or clearance is informational only and not by itself a basis for coverage. Regulatory statements and device listings are provided for reference, but coverage determinations must rely on the clinical evidence and applicable benefit, state, or federal requirements.

Within the provided excerpts there are no additional explicit exclusions listed beyond those addressing other laser procedures and specified contexts; coverage decisions must follow InterQual criteria and applicable federal, state (OAC), or contractual benefit plan requirements.

Policy statement: procedures identified in the policy that are not specifically listed as proven (i.e., laser techniques beyond iridotomy/iridoplasty/laser ciliary body destruction and other device uses lacking strong evidence) are considered unproven and not medically necessary for glaucoma treatment absent stronger comparative or long-term data.

The policy repeatedly cites evidence limitations—heterogeneous study designs, small sample sizes, retrospective cohorts, short follow-up, and potential manufacturer-related bias—which constrain conclusions about comparative effectiveness for many devices and techniques (for example, some canal-based MIGS and OMNI), supporting conservative coverage approaches and requirements for documentation.

In some device contexts the evidence is insufficient to establish durable comparative benefit. For example, the XEN Gel Stent evidence base is dominated by retrospective series with frequent postoperative interventions and limited RCT data; similarly, OMNI and other ab-interno canal procedures have only low-quality comparative data, supporting classification of certain uses as investigational pending stronger randomized evidence.

Although the document does not provide a discrete checklist labeled 'not medically necessary' in these excerpts, it describes that interventions lacking comparative or long-term evidence—such as standalone KDB trabeculectomy, certain novel MIGS or laser procedures (ELT, FLT, OCT-guided approaches)—may be considered investigational or not medically necessary without supportive evidence and appropriate clinical justification.

No high-quality comparative evidence demonstrates clear superiority of OMNI, Trabectome, or many canal-based MIGS over conventional filtration surgery; available studies are small, nonrandomized, or short-term, and therefore broad unrestricted coverage is not supported by the current evidence.

Standalone KDB trabeculectomy and other less-evaluated MIGS or laser procedures lack sufficient comparative effectiveness data and long-term outcomes in the literature cited; absent robust RCTs and longer follow-up, these procedures may be subject to restricted coverage or require prior authorization with supporting clinical rationale.

Within the provided excerpt there are no additional explicit statements labeled 'not medically necessary' beyond the general policy positions that other/unproven laser procedures and interventions without adequate evidence are not medically necessary.

Applicable Procedure and Regulatory Codes

Applicable CPT/T Codes (part 1)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.

1–10 of 12

1/2

Applicable CPT/T Codes (part 2)mixed

66175	Transluminal dilation of aqueous outflow canal (e.g., canaloplasty); with retention of device or stent.
66179	Aqueous shunt to extraocular equatorial plate reservoir, external approach; without graft.
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.
66710	Ciliary body destruction; cyclophotocoagulation, transscleral.
66711	Ciliary body destruction; cyclophotocoagulation, endoscopic, without concomitant removal of crystalline lens.
66761	Iridotomy/iridectomy by laser surgery (e.g., for glaucoma) (per session).
66762	Iridoplasty by photocoagulation (1 or more sessions) (e.g., for improvement of vision, for widening of anterior chamber angle).

Cataract combined procedure codes and HCPCSmixed

66989	Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), complex, with insertion of anterior segment aqueous drainage device, without extraocular reservoir, internal approach, one or more.
66991	Extracapsular cataract removal with insertion of intraocular lens prosthesis (1-stage procedure), with insertion of intraocular anterior segment aqueous drainage device, without extraocular reservoir, internal approach, one or more.
L8612	Aqueous shunt (HCPCS).

No explicit CPT/HCPCS/ICD codes in this excerptmixed

No codes listed

Procedural codes referenced in studies (not listed explicitly in excerpt)mixed

No codes listed

FDA product codes mentionedmixed

HMX	cannula, ophthalmic (product code referenced for devices)
MPA	endoilluminator / pump infusion ophthalmic (product code referenced)
MRH	pump, infusion, ophthalmic (product code referenced)
HMZ	trabeculotomy (product code referenced)

FDA product codes referencedmixed

HMX	cannula, ophthalmic (product code)
MPA	endoilluminator (product code)
MRH	pump, infusion, ophthalmic (product code)
HMZ	trabeculotomy (product code)
KYF	Implant, Eye Valve (product code)

Specific FDA 510(k)/PMA identifiersmixed

K062259	Canaloplasty Ophthalmic Microcannula (iTRACK) 510(k)
K211680	Streamline Surgical System (Viscoelastic Injector) 510(k)
K030350	ExPRESS Mini Glaucoma Shunt 510(k)
P170043	iStent inject PMA
P170034	Hydrus Microstent PMA
K161457	XEN Glaucoma Treatment System 510(k)
K230722	Eagle laser system 510(k)
K140336	OPTIMIS FUSION family (SLT/YAG) 510(k)

Applicable CPT Codes (added/updated)CPT

1012T

CPT code added (description not provided in this chunk)

MIGS effectiveness threshold

Effectiveness benchmarkMIGS should provide at least 20% reduction in intraocular pressure (IOP) or a reduction of at least one glaucoma medication.

Typical candidateAdults with mild to moderate glaucoma, commonly combined with phacoemulsification (cataract) and not suitable for advanced disease requiring very low IOP goals.

Procedure approachMIGS are typically performed via an ab interno approach with minimal disruption of ocular anatomy and lower complication risk than traditional filtering surgery.

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Code list for authorization reference

Prior authorization may be required for many microinvasive glaucoma surgery (MIGS) and glaucoma laser procedures. Prior authorization requests should reference the applicable procedure codes (see code list below) and include the clinical rationale and documentation supporting the requested procedure. Inclusion of a code in this policy is for reference only and does not guarantee coverage; benefit plan, federal, and state (Ohio Administrative Code) requirements apply.

Authorization reference codes: see applicable CPT/HCPCS list in policy Applicable Codes (0253T, 0449T, 0450T, 0474T, 0621T, 0622T, 0671T, 0730T, 1012T, 65820, 65855, 66174, 66175, 66179, 66180, 66183, 66710, 66711, 66761, 66762, 66989, 66991, L8612)
Include CPT/HCPCS descriptors and any relevant modifier when submitting for authorization

Prior Authorization

Prior authorization for MIGS with cataract surgery

Prior authorization is recommended when MIGS devices or procedures are billed in combination with cataract surgery. Many MIGS devices (e.g., iStent, iStent inject, Hydrus, OMNI when used with phacoemulsification) have FDA indications tied to concurrent cataract surgery; documentation must show the patient has an indication (mild to moderate open-angle glaucoma) and is currently on ocular hypotensive medication.

Background and Context

Background: glaucoma surgical and laser interventions vary in intended patient population and expected benefit. The policy identifies specific procedures as proven when used in defined clinical contexts (for example, certain MIGS and microstents when combined with cataract surgery in adults) and contrasts these with other laser or novel procedures for which evidence is insufficient.

Definitions and Device Descriptions

Primary open-angle glaucoma (POAG)

DefinitionA 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 optic nerve change.

Clinical featuresOptic disc/RNFL structural abnormalities and reliable, reproducible visual field defects; severity classified as mild, moderate, severe, or indeterminate based on imaging and SAP.

Typical patient populationAdults with primary open-angle glaucoma (POAG) often considered for MIGS when disease is mild to moderate.

Canaloplasty (ab interno/ab externo)

DefinitionSurgical viscodilation of Schlemm's canal to restore aqueous outflow performed via ab externo or ab interno approaches.

Ab externo technique

Policy Summary

PayerUnitedHealthcare

PolicyGlaucoma Surgical Treatments (for Ohio Only)

Policy CodePolicy CS050OH.D

Change TypeOperative/coding update (CPT 1012T added)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, prior treatments, baseline IOP and rationale when requesting MIGS or less-established procedures.

SourceLink

On This Page

AAO guidance and policy context; see chunk 101

HORIZON trial and ECRI findings; see chunks 33-36

XEN Gel Stent evidence synopsis: Observational and systematic review data show clinically meaningful IOP and medication reductions with XEN but frequently require postoperative interventions (e.g., needling) and lack robust RCT evidence in many contexts.

See XEN reviews and case series; chunks 47, 51, 54

Selective Laser Trabeculoplasty (SLT) evidence synopsis: The randomized LIGHT trial demonstrated durable IOP control with initial SLT and favorable long‑term outcomes compared with topical drops, supporting SLT as an effective nonincisional option for OAG/OHT.

LIGHT trial results; chunk 55

Cyclodestructive procedures (CPC, micropulse): Cochrane review concludes evidence is inconclusive for cyclodestructive procedures versus alternatives; these are generally reserved for refractory cases given risks such as hypotony and phthisis bulbi.

Cochrane review; see chunk 60

Ab‑interno canaloplasty/OMNI/Streamline: Case series and limited studies report IOP and medication reductions at up to 12–24 months for ab‑interno canaloplasty and combined canaloplasty/trabeculotomy (OMNI, Streamline), but evidence quality is low and RCTs are lacking.

Gallardo, ECRI and other series; see chunks 67, 70, 73

Refractory device pathway and conservative therapy considerations; see chunks 54, 55, 46

Requests for unproven procedures: Requests for procedures designated unproven or investigational (including many other laser techniques and standalone uses without robust evidence) will be evaluated under applicable state and contractual rules and may be denied absent adequate supporting clinical evidence and justification.

Denial risk and unproven services review; see chunks 2 and 104-106

When device is FDA-approved only in combination with phacoemulsification (e.g., iStent, iStent inject, Hydrus), authorization requests should indicate concurrent cataract surgery (CPT 66989/66991) and include lens status/diagnosis
If device is being requested as a standalone procedure (off-label use), include justification, prior treatments tried, and rationale for standalone approach

Documentation Required

Prior authorization: rationale and required clinical information

Rationale for prior authorization: to confirm medical necessity, eligibility under plan/state rules, appropriate device indication, and adequacy of conservative/less-invasive treatment trials. Requests must include specific clinical information to support the selection of the procedure.

Required clinical information: baseline and pre-treatment IOP (with measurement method), target IOP goals, visual field status, optic nerve findings, and prior glaucoma treatments (medications, laser, prior surgeries)
Clinical rationale: indication for surgery (IOP control vs medication reduction vs refractory disease), explanation why less invasive options (medical therapy, SLT) are inadequate or inappropriate
For combined procedures, document cataract severity and the expected benefit from concurrent cataract extraction

Prior Authorization

Prior authorization for novel/less-established procedures

Prior authorization is strongly recommended for novel or less-established procedures and devices (e.g., Streamline Surgical System, certain standalone KDB trabeculotomy approaches, newer OMNI indications outside FDA-labeled uses). These may be considered investigational or require additional justification and outcome expectations.

For novel/less-established devices include published evidence, peer-reviewed studies, anticipated benefit compared to standard treatments, and plan for follow-up and outcomes monitoring
Be prepared for requests for peer-reviewed literature, manufacturer device identifiers, and rationale why established alternatives are not appropriate

Prior Authorization

Prior authorization may be required for less-established MIGS and laser procedures

Some less-established MIGS and laser procedures (including experimental or off-label uses) may require prior authorization or may be denied as unproven. Examples include standalone stent implantation without evidence of benefit compared with cataract surgery alone and newer laser techniques without sufficient published data.

Standalone stent implantation lacking evidence of benefit compared with cataract surgery alone may be a basis for denial
Other laser procedures (ELT, FLT, OCT-guided trabeculotomy) lack high-quality evidence and are not FDA-approved for glaucoma; authorization requests will be scrutinized

Note

Device approvals referenced (may affect authorization)

Device regulatory approvals and clearance status can affect authorization decisions. FDA approvals indicate labeled indications but do not by themselves guarantee coverage; include regulatory identifiers when available.

Include FDA PMA/510(k) numbers or product codes (examples: iStent PMA P170043; Hydrus PMA P170034; XEN K161457; ExPRESS K030350; Eagle SLT laser K230722; OMNI product codes listed in FDA database)
Note: FDA approval is informational only; coverage is determined per plan/state rules

Denial Risk

Unproven services review

Unproven or not medically necessary services will be evaluated per Ohio Administrative Code and plan contract. Procedures identified in the policy as unproven (including many other laser procedures and interventions without sufficient evidence) may be denied.

All services deemed unproven or lacking sufficient evidence will be reviewed against Ohio Administrative Code 5160-101 and contractual provisions
Requests for unproven procedures should include robust justification and supporting clinical evidence; absence of adequate evidence may result in denial

Denial Risk

Lack of evidence of clinical benefit compared with cataract surgery alone may be a basis for denial

Lack of evidence of clinical benefit compared with cataract surgery alone is a common reason for denial for standalone stent implantation and other adjunctive procedures without adequate comparative data.

When requesting standalone implantation, demonstrate comparative benefit over cataract surgery alone with high-quality data or individualized clinical rationale
Documentation should address long-term IOP control, reduction in medication burden, and need to avoid additional glaucoma surgery

Denial Risk

Complication-related documentation risk

Complication history, risk profile, and the potential need for postoperative interventions should be documented. Incomplete documentation of complications or risk mitigation may increase denial risk or prompt requests for additional information.

Document prior ocular surgeries, existing corneal/endothelial status, history of intraocular inflammation, prior glaucoma drainage procedures, and anticipated perioperative risks
Include plan for managing common complications (e.g., transient IOP spikes, hyphema, need for secondary glaucoma surgery) and follow-up schedule

Documentation Required

Documentation/Indication risks

Documentation and indication risks: inadequate or vague clinical records may lead to requests for more information or denial. Ensure records clearly support procedure choice and demonstrate why alternatives were insufficient.

Documentation supporting selection of specific angle surgeries (goniotomy, trabeculotomy, combined procedures) should include diagnosis, prior therapies, and objective measures
Provide ophthalmic examination findings, diagnostic testing (visual fields, OCT RNFL where available), and trials of medical/laser therapy

Denial Risk

Other laser procedures (ELT, FLT, OCT-guided) lack high-quality evidence

Other laser procedures (ELT, FLT, OCT-guided trabeculotomy) currently lack sufficient high-quality evidence and are not FDA-approved for glaucoma treatment in the US. Authorization requests for these procedures will be evaluated carefully and may be denied.

ELT, FLT, and OCT-guided laser trabeculotomy: not FDA-approved for glaucoma — include robust peer-reviewed evidence if requesting coverage
Hayes and other reviews report insufficient published peer-reviewed data to support routine coverage

Note

FDA approval informational

FDA approval information is provided for informational purposes only. FDA labeling may restrict a device to use in combination with other procedures; use outside labeled indications is off-label and may require additional justification for coverage.

Examples: iStent/iStent inject and Hydrus are FDA-approved for use in conjunction with cataract surgery in specified patient populations; XEN and others have specific approvals and predicates listed
Provide PMA/510(k) identifiers when available to help reviewers verify labeled indications

Billing Rule

Coding and benefit documentation

Coding and benefit verification: codes listed in the policy are provided for reference. Providers must verify member benefits, prior authorization requirements, and coding guidance with the payer prior to performing procedures.

Confirm whether the procedure code is covered under the member's specific plan and obtain prior authorization when required
When submitting authorization or claims, include all relevant CPT/HCPCS codes, diagnosis codes, and any pertinent modifiers

Documentation Required

Required clinical documentation

Required clinical documentation for authorization: include detailed medical records and objective data to support medical necessity. Incomplete or absent documentation may delay review or result in denial.

Baseline IOP measurements (method and dates), target IOP, visual field and optic nerve assessments, medication history, prior laser or surgical glaucoma interventions
Procedure-specific details: intended anatomic target (trabecular meshwork, Schlemm's canal, subconjunctival), device model/manufacturer, and whether performed with cataract surgery

Documentation Required

Clinical records should document baseline IOP, target IOP goals, prior glaucoma treatments, and specific surgical intent

Clinical records should document baseline IOP, target IOP goals, prior glaucoma treatments, and specific surgical intent (IOP-lowering vs medication reduction). Clear documentation of goals and prior therapy supports appropriate clinical decision-making and authorization.

Include washout IOP if relevant, number and class of topical/systemic glaucoma medications, prior efficacy of SLT or other lasers, and reasons for escalation to surgery
State explicit expected outcome (e.g., decrease IOP to X mmHg, reduce medication burden by Y agents) and follow-up plan

Note

Device regulatory identifiers

Device regulatory identifiers should be provided when available to facilitate device verification and indication matching. This includes PMA/510(k) numbers and FDA product codes.

Provide PMA or 510(k) numbers, product codes (e.g., HMX, MPA, MRH, KYF), and device model names when submitting authorization requests
Including these identifiers helps reviewers confirm labeled indications and predicate device information

Documentation Required

Documentation and reference requirements

Documentation and reference requirements: when citing studies or evidence in support of a novel or less-established procedure, include full citations and, when possible, peer-reviewed publications rather than abstracts or manufacturer summaries.

Attach copies or citations of pivotal RCTs, systematic reviews, or technology assessments used to justify the request
If relying on real-world evidence or case series, clearly explain limitations and why they support the requested intervention for the individual patient

Documentation Required

Consideration of less invasive or alternative therapies

Consideration of less invasive or alternative therapies should be documented prior to approval of more invasive or novel procedures. Trials of conservative therapy and laser trabeculoplasty are often appropriate first steps for many patients with POAG.

Document trials of maximally tolerated medical therapy and the use or failure of SLT where clinically indicated
If bypassing less invasive options, provide clinical justification (e.g., intolerance to medications, rapid progression, anatomy unsuited to SLT)

Step Therapy

Consider less invasive therapy first

Consider less invasive therapy first when clinically appropriate. SLT has robust evidence supporting use as initial or adjunctive therapy for POAG and should be considered before certain surgical interventions in eligible patients.

When SLT is clinically appropriate and not contraindicated, document whether it was tried and the response before escalating to MIGS or filtering procedures
Provide dates and outcomes of SLT when included in the clinical course

Documentation Required

Conservative therapy consideration

Conservative therapy consideration: ensure documentation of medication trials, adherence issues, and intolerance to topical agents if claiming failure of medical therapy.

List prior glaucoma medications, doses, duration, documented adherence, and adverse effects or contraindications
If medical therapy was limited by intolerance, provide clinical notes supporting adverse reactions

Step Therapy

Step therapy not specified

Step therapy is not prescriptively specified in this policy. Decisions about sequencing of interventions (medication, laser, MIGS, filtering surgery) should follow clinical judgment, plan benefit terms, and Ohio Administrative Code as applicable.

Where plan-level step therapy or utilization management programs exist, follow those operational rules in addition to this policy
If uncertainty exists, obtain prior authorization and include clinical justification for the requested sequencing

Note

AAO guidance: MIGS often produce more modest IOP reductions than trabeculectomy or aqueous shunts; consider escalation when needed

AAO guidance notes that MIGS often produces more modest IOP reductions than trabeculectomy or aqueous shunt surgery and may be most appropriate when a moderate IOP-lowering goal is acceptable. Consideration should be given to escalation to more invasive filtration procedures when target IOP is not met.

Document target IOP and discuss whether MIGS is expected to meet that target; if not, include reasoning for choosing MIGS (e.g., safety profile, medication reduction)
If previous MIGS or less-invasive approaches failed, document rationale for choosing more invasive filtration procedures

Microcatheter inserted through conjunctiva and sclera with an intracanalicular suture to tension the trabecular meshwork and open Schlemm's canal.

Ab interno techniqueMicrocatheter inserted through a clear corneal or limbal incision into Schlemm's canal with viscoelastic dilation; often used with devices like iTRACK or OMNI.

MIGS (Microinvasive Glaucoma Surgery)

Class descriptionMicroinvasive glaucoma surgery (MIGS) is a group of ab interno procedures, frequently combined with phacoemulsification, that lower IOP with less anatomic disruption and lower complication risk than traditional filtering surgery.

ExamplesIncludes trabecular bypass stents (iStent, iStent inject, Hydrus), tissue excision procedures (KDB goniotomy, Trabectome, GATT), canal-based approaches (ABiC/OMNI/Visco360), suprachoroidal or subconjunctival shunts (e.g., CyPass, XEN), and cilioablative techniques (ECP).

Effectiveness requirementTo be considered effective, a MIGS procedure should achieve ≥20% IOP reduction or reduce IOP-lowering medications by at least one.

Primary congenital glaucoma (PCG)

DefinitionPrimary congenital glaucoma (PCG) is a pediatric form of glaucoma treated surgically; multiple techniques (goniotomy, trabeculotomy, combined procedures) have been compared in trials.

Evidence summarySystematic reviews include randomized and quasi-randomized trials (16 trials, 587 eyes) showing limited comparative evidence; 360° microcatheter-assisted trabeculotomy may be more beneficial but with more adverse effects.

Clinical implicationSurgical selection should consider patient age, disease severity, and available trial evidence; multicenter trials with longer follow-up are needed due to disease rarity.

MIGS (microinvasive glaucoma surgery)

Device examplesAb interno implantable devices include iStent, iStent inject, and Hydrus Microstent, often implanted at the time of cataract surgery to lower IOP and reduce medication dependence.

Indication contextMIGS devices are typically indicated for adults with mild to moderate OAG undergoing cataract extraction who are on ocular hypotensive medication.

Expected outcomesRandomized and nonrandomized studies report modest additional IOP and medication reductions versus cataract surgery alone; device-specific benefits vary by trial.

Complete success

Complete success (trial definition)Target endpoint intraocular pressure (IOP) achieved without use of antiglaucoma medications, as defined in included trials.

UsageCommonly used in randomized trial outcome reporting comparing drainage devices or trabeculectomy/EX-PRESS implants.

InterpretationComplete success indicates surgical control of IOP without need for ongoing topical therapy; rates vary by device and study follow-up.

Qualified success

Qualified success (trial definition)Target endpoint IOP achieved with or without antiglaucoma medications, as defined in included trials.

Clinical meaningQualified success acknowledges IOP control that may still require medical therapy; used alongside complete success to describe outcomes.

ReportingMany RCTs and meta-analyses report both complete and qualified success to capture differences in medication dependence postoperatively.

Refractory glaucoma

DefinitionRefractory glaucoma describes disease that remains uncontrolled after prior filtering or cilioablative procedures and/or uncontrolled IOP on maximally tolerated medical therapy.

Typical interventionsAqueous shunts (Ahmed, Baerveldt, Molteno, EX-PRESS) and other drainage devices are indicated for refractory cases where less invasive treatments have failed or are inappropriate.

Evidence considerationsComparative evidence for refractory contexts varies; RCTs and systematic reviews evaluate tube shunts versus trabeculectomy with mixed results on efficacy and complications.

Selective laser trabeculoplasty (SLT)

DefinitionSelective laser trabeculoplasty (SLT) is a laser procedure to lower IOP by improving trabecular outflow and may be used as initial or adjunctive therapy for POAG or ocular hypertension.

Key evidenceThe LIGHT randomized trial (629 patients) demonstrated durable disease control with 69.8% at target IOP without additional medication/surgery at 6 years and less progression versus drops.

Clinical roleConsider SLT as a less invasive option before surgical implants when clinically reasonable; documentation of prior treatments and goals is recommended for authorization decisions.

Ab interno canaloplasty with trabeculotomy (OMNI)

Procedure descriptionAb interno canaloplasty with trabeculotomy (OMNI) combines 360° microcatheterization and viscodilation of Schlemm's canal followed by trabeculotomy via an ab interno approach using an integrated device.

Expected outcomesCase series and small studies report significant IOP and medication reductions (e.g., medication-free rates up to ~78% at 6 months in some cohorts) but long-term comparative evidence is limited.

Evidence limitationsMost data are from case series or single-arm studies with limited follow-up; larger randomized trials are needed to define comparative effectiveness versus other MIGS or filtration surgery.

KDB goniotomy

DefinitionKahook Dual Blade (KDB) goniotomy is an excisional goniotomy that removes a strip of trabecular meshwork to enhance aqueous outflow, often performed with phacoemulsification.

Evidence summarySystematic reviews and RCTs (e.g., Radwan 2024; Falkenberry 2020) report greater IOP and medication reduction with KDB+phaco vs phaco alone and favorable short-term safety, though study heterogeneity is high.

Common outcomesReported mean IOP reductions and greater medication savings compared with phaco alone; complications include hyphema and transient IOP spikes.

GATT

DefinitionGonioscopy-assisted transluminal trabeculotomy (GATT) is a 360° ab interno trabeculotomy performed with a microcatheter or suture to cleave the trabecular meshwork circumferentially.

Evidence summaryCase series and systematic reviews report significant IOP and medication reductions with GATT but most studies lack randomized comparators and have variable follow-up.

Clinical contextsPerformed standalone or combined with cataract surgery; common complication is hyphema; RCTs are needed for stronger comparative evidence.

Trabectome

DefinitionTrabectome is an electrosurgical ab interno device that ablates trabecular meshwork under microscopic visualization to lower IOP; can be standalone or combined with cataract surgery.

Evidence qualityEvidence is low quality with systematic reviews and nonrandomized studies; properly designed RCTs are needed to assess long-term efficacy and safety versus other approaches.

Reported outcomesStudies report IOP lowering and medication reduction but heterogeneity and risk of bias limit conclusions about comparative effectiveness.

OMNI Surgical System

Device descriptionThe OMNI Surgical System is a handheld device used to access, microcatheterize, and viscodilate Schlemm's canal for canaloplasty and to cut trabecular meshwork tissue for trabeculotomy.

Regulatory noteThe OMNI system is described in FDA informational sections; device product codes include MRH (pump/infusion) and HMZ (trabeculotomy).

Clinical useUsed for combined ab interno canaloplasty and trabeculotomy procedures (e.g., OMNI, Streamline) often in mild to moderate OAG, sometimes combined with phacoemulsification.

iTRACK (Canaloplasty Ophthalmic Microcannula)

Device descriptioniTRACK (Canaloplasty Ophthalmic Microcannula) is a flexible microcannula designed for atraumatic cannulation and infusion/aspiration during ophthalmic surgery; FDA-cleared in 2006.

Intended useUsed to cannulate Schlemm's canal and deliver viscoelastic during canaloplasty procedures via ab interno or ab externo approaches.

Regulatory referenceListed under FDA product code K062259 and described in the FDA informational section for device context.

Excimer laser trabeculostomy (ELT)

Procedure descriptionExcimer laser trabeculostomy (ELT) is an invasive surgical laser procedure for glaucoma that has shown favorable outcomes compared with some MIGS in non-US jurisdictions.

Regulatory statusELT has been approved for use in the European Union and Switzerland; clinical studies are pending or limited in Canada and the U.S.

Evidence considerationsExisting studies suggest positive signals but randomized multicenter data in the U.S. are limited; further research is needed to establish comparative effectiveness and safety.

MIGS (Microinvasive Glaucoma Surgery)

MIGS class overviewMIGS are ab interno, usually phaco-combined procedures that lower IOP with favorable safety profiles but typically less IOP reduction than filtering surgery.

Effectiveness thresholdConsidered effective if achieving ≥20% IOP reduction or reducing at least one glaucoma medication.

Common devices/proceduresIncludes trabecular bypass stents (iStent, iStent inject, Hydrus), KDB goniotomy, GATT, Trabectome, OMNI/ABiC/Visco360 canal procedures, XEN Gel Stent, and cyclodestructive procedures (CPC/ECP).

Evidence and limitationsRandomized and nonrandomized studies show modest IOP and medication reductions; many device-specific results are limited by single-arm designs, short follow-up, or heterogeneity across studies.

References

Key referencesSamuelson et al. (iStent inject pivotal RCT, 2019a); Samuelson et al. (iStent earlier pivotal RCT, 2011); Samuelson et al./HORIZON (Hydrus RCT, 2019b) and Ahmed et al. 3- and 5-year updates.

Systematic reviewsCochrane and other systematic reviews/meta-analyses summarizing GATT, KDB, Hydrus, XEN, and other MIGS are cited to inform evidence strength and limitations.

Guidelines and device infoAAO Preferred Practice Patterns and FDA device summaries (e.g., iTRACK K062259, iStent PMA P170043, Hydrus PMA P170034) are included as supporting documents.