Novel Injection Methods
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Defines Aetna's coverage stance for novel ophthalmic injection methods (suprachoroidal injections, subretinal rtPA, and vessel-wall micro-infusion devices) affecting providers who perform or bill for these procedures and related drugs.
No material clinical or coverage changes in this revision.
Coverage Criteria
Suprachoroidal triamcinolone (Xipere) for macular edema associated with uveitis
Covered when ALL of the following are met:
See referenced CPB 1000 for specific selection criteria.
Subretinal injection of rtPA for sub-macular hemorrhage
Covered when ALL of the following are met:
Procedure CPT 0810T applies; recombinant rtPA has no specific HCPCS code listed in this policy. Cite appropriate ICD-10 diagnosis codes for retinal hemorrhage (e.g., H35.60–H35.63).
Suprachoroidal delivery of other pharmacologic agents
Not covered / investigational:
Claims for these uses are subject to denial.
Mercator Bullfrog micro-infusion device
Not covered / investigational:
Includes related HCPCS code C9759; use may be denied.
Evidence-summary and investigational stance for novel injection methods
Summarized coverage-relevant conclusions and evidence limits from the document:
Further larger controlled trials are needed to establish definitive safety and effectiveness.
Study eligibility included BCVA 20–70 letters and CST >300 μm.
Currently preclinical evidence only.
May be denied for indications lacking supporting clinical evidence; includes HCPCS C9759.
Procedure CPT 0810T applies; clinical judgment required for patient selection.
This policy notes that Aetna covers suprachoroidal injection of triamcinolone acetonide injectable suspension (Xipere) for macular edema associated with uveitis when the criteria in CPB 1000 are met. For other pharmacologic agents delivered to the suprachoroidal space, coverage is not established and those uses are considered experimental and investigational. Relevant billing guidance identifies CPT 67516 and HCPCS J3299 for Xipere when selection criteria are satisfied; providers should follow the referenced CPB for specific patient selection and documentation requirements.
Clinical and preclinical reports emphasize that not all agents are suitable for suprachoroidal space (SCS) injection because some molecules, particularly highly aqueous-soluble agents, are cleared rapidly from the SCS. Studies to date predominantly used CLS-TA (Xipere) because it demonstrates favorable posterior distribution and slower clearance; additional formulation work or delivery strategies are needed to enable sustained therapeutic levels for other agents. Providers should be aware that rapid SCS clearance and limited targeting to posterior segments are key biologic limitations that affect suitability of alternative drugs for this route.
Aetna considers suprachoroidal injection of all pharmacologic agents other than triamcinolone acetonide (Xipere) to be not medically necessary / experimental and investigational for all indications because effectiveness has not been established. Claims for these uses are subject to denial.
The Mercator Bullfrog micro-infusion device is described as a balloon‑tipped, micro‑needle system intended to deliver agents into adventitial or peri‑vascular tissues. Although it has FDA 510(k) clearance for selected peripheral and coronary vessel uses, Aetna considers use of this device for direct adventitial delivery in the contexts described by this policy to be experimental and investigational due to a lack of evidence demonstrating safety and effectiveness; such uses may be considered not medically necessary and are subject to denial. The related HCPCS code is C9759.
Coding
| 67516 | Suprachoroidal space injection of pharmacologic agent (separate procedure) |
| J3299 | Injection, triamcinolone acetonide (Xipere), 1 mg |
| H35.81 | Retinal edema |
| H35.60 | Retinal hemorrhage, unspecified |
| H35.61 | Retinal hemorrhage, preretinal |
| H35.62 | Retinal hemorrhage, subretinal |
| H35.63 | Retinal hemorrhage, intraretinal |
| No codes listed |
Provider Actions and Billing Guidance
Prior Authorization Required
Prior authorization is expected for covered suprachoroidal injection of triamcinolone acetonide (Xipere) when medical necessity criteria are met. Submit the appropriate CPT/HCPCS along with an ICD-10 diagnosis that supports the indication.
Clinical Trial Eligibility Documentation
Document clinical trial eligibility elements when applicable. For studies of suprachoroidal agents combined with intravitreal therapy, include prior treatment history, baseline best-corrected visual acuity (BCVA), central subfield thickness (CST), and pre-specified retreatment criteria (eg, timing and BCVA/CST thresholds).
- Trials commonly enrolled treatment‑naive patients with BCVA 20–70 letters and CST >300 μm.
- Report retreatment schedule and any as‑needed (PRN) dosing criteria used in the trial (eg, weeks allowed for additional intravitreal therapy).
Experimental Suprachoroidal Agents
Suprachoroidal delivery of pharmacologic agents other than triamcinolone acetonide injectable suspension (Xipere) is considered experimental and investigational for all indications due to insufficient evidence of safety and effectiveness. Do not bill covered suprachoroidal codes for these agents.
- Experimental suprachoroidal agents: any pharmacologic agent delivered suprachoroidally other than Xipere.
- Do not use CPT/HCPCS listed as covered for Xipere when the agent is not Xipere; such use may be denied as experimental.
Comparative Step Considerations
Comparative step considerations: when suprachoroidal CLS‑TA has been studied in combination with intravitreal aflibercept, studies showed similar mean BCVA gains versus aflibercept monotherapy but greater CST reduction and fewer total treatments in the combination arm. Consider that combination therapy may reduce number of intravitreal treatments but has not shown superior BCVA in the referenced trial.
- Active group (CLS‑TA + aflibercept) vs aflibercept monotherapy: similar BCVA change at 24 weeks; greater CST reduction in active group; fewer scheduled plus as‑needed treatments (average 2.6 vs 4.6).
- No treatment‑related serious adverse events observed in the referenced study.
Investigational Device Risk
Investigational device risk: the Mercator Bullfrog micro‑infusion device is considered experimental and investigational for adventitial delivery via blood vessel walls due to lack of evidence on safety and effectiveness; claims for its use (eg, HCPCS C9759) may be denied.
- Bullfrog device: experimental/investigational for direct adventitial delivery — lack of clinical evidence.
- Billing note: HCPCS C9759 (transcatheter intraoperative blood vessel microinfusion) is listed as not covered for indications in this CPB and may be denied.
Background
Background: The posterior segment of the eye — including the retina, macula and choroid — is relatively difficult to access. Traditional delivery approaches include intravitreal and peri‑ocular injections and implants. The suprachoroidal space (SCS) has been investigated as an alternative route to target posterior tissues, with the potential advantage of higher local posterior‑segment exposure and reduced anterior segment exposure, but practical challenges remain in reliably delivering and retaining drugs at the posterior pole.
Definitions
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