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Verteporfin (Visudyne) Photodynamic Therapy
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This policy governs coverage and medical necessity criteria for photodynamic therapy (PDT) with light-activated verteporfin (Visudyne) for commercial medical plans; it specifies indications, continuation criteria, coding references, and investigational uses. It affects providers requesting authorization and payers adjudicating PDT claims.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
inv-01: Initial Approval — Medically Necessary Indications
Covered when ALL of the following are met:
Based on FDA-approved indications and compendial uses; verteporfin dosing typically 6 mg/m2.
inv-02: Continuation of Therapy
Covered when ALL of the following are met:
Re-evaluation at approximately 3 months after treatment; retreatment may be considered if fluorescein angiography or OCT demonstrates persistent or recurrent leakage.
inv-03: Clinical contexts supported by cited evidence
Evidence-supported clinical contexts described in these excerpts (no explicit policy coverage criteria stated here):
Supported by reviews and combination studies.
Multiple small studies; protocols varied.
Treatment parameters and follow-up varied by study.
inv-04: FDA-approved indications
Covered for FDA-approved ocular indications when documented appropriately:
FDA approval and supporting trial data referenced in background.
inv-05: Select non-standard ocular indications
May be considered medically necessary in select cases when ALL of the following are met:
Evidence primarily from case series and small prospective cohorts; prior authorization and detailed documentation are recommended.
inv-06: Myopic CNV treatment preference
When treating choroidal neovascularization secondary to pathologic myopia:
Meta-analyses and RCT evidence inform preference for anti-VEGF over PDT.
inv-07: Evidence summaries by indication
Evidence summaries for specific indications (extracted as separate groups):
Preliminary evidence; larger/longer studies needed.
Negative efficacy signal for 100% occult lesions.
Variable long-term outcomes; many small studies.
Evidence supports combined therapy as potentially more effective but further high-quality RCTs are needed.
inv-08: Evidence summary and investigational stance by indication
Summary of reported evidence and contexts where verteporfin PDT was studied:
Supports combined therapy as potentially more effective; consider diagnostic confirmation (eg, ICGA) and documentation when seeking PDT for PCV.
Preliminary evidence; variable PDT settings across centers.
Half-dose PDT may be an option in select cases.
Investigational oncology application; guideline omission may affect coverage.
Considered investigational pending robust clinical trials.
Aetna considers Visudyne (verteporfin) photodynamic therapy experimental and investigational for a broad list of indications because effectiveness has not been established. Examples include dermatologic uses (e.g., alopecia areata, psoriasis), many ocular conditions outside the primary labeled indications (e.g., angioid streaks, idiopathic CNV, retinal angiomatous proliferation, retinal capillary hemangioma, parafoveal CNV), numerous oncologic indications (e.g., breast, colon, pancreatic, endometrial, ovarian, soft tissue sarcoma, choroidal metastasis, retinoblastoma, glioblastoma), vascular applications (e.g., intra-arterial atherosclerotic plaque), and investigational delivery methods (e.g., in-situ gelation-based verteporfin delivery). Simultaneous use of Visudyne PDT with intravitreal anti-angiogenic agents for CNV due to AMD is also considered experimental/investigational.
A 2005 practice guideline on photodynamic therapy for choroidal neovascularization due to AMD and other causes did not list central serous retinopathy (CSR/CSC) as an indication for Visudyne; while later small studies evaluated reduced‑dose or reduced‑fluence PDT for chronic CSC, CSR/CSC was not included in that earlier guideline as a recognized indication.
Use of verteporfin PDT for many reported indications remains unproven: available evidence for conditions such as angioid streaks, central serous chorioretinopathy, inflammatory or idiopathic CNV, and polypoidal choroidal vasculopathy (PCV) is largely limited to case reports, small case series, and nonrandomized studies, and Aetna therefore considers many of these uses investigational.
Non‑ocular oncology and cardiovascular uses of verteporfin PDT are investigational. Preclinical and early clinical work (e.g., nanoparticle delivery in breast cancer models, liposomal strategies, and in‑vitro or organoid studies in endometrial cancer) exist, but these indications (including intra‑arterial PDT for atherosclerotic plaque and various systemic malignancies) lack established effectiveness for clinical coverage.
Randomized trial data did not demonstrate benefit of verteporfin PDT for lesions that are 100% occult (no classic component); based on that negative efficacy signal the European regulatory authority (EMEA) rescinded approval for the 100% occult CNV indication.
The National Comprehensive Cancer Network (NCCN) clinical practice guideline for pancreatic adenocarcinoma (Version 1.2022) does not list photodynamic therapy or verteporfin as a therapeutic option, indicating that PDT is not recognized as a standard treatment for pancreatic cancer in that guideline.
Billing the verteporfin HCPCS drug code J3396 for concurrent use with intravitreal anti‑angiogenic agents is noted as not covered in combination; claims for simultaneous administration billed as a combination may be denied because combined use in this setting is considered experimental/investigational.
Verteporfin PDT as first‑line therapy for choroidal neovascularization secondary to pathologic myopia is generally not supported by comparative evidence: meta‑analysis and pooled data indicate intravitreal anti‑VEGF therapy achieves superior visual outcomes versus verteporfin PDT, so anti‑VEGF is the preferred initial treatment unless contraindicated.
Use of verteporfin PDT for occult CNV lesions that lack any classic component is not supported by the cited randomized trial and therefore is considered not effective for that subgroup.
Topical ALA‑PDT for chronic plaque psoriasis demonstrated inconsistent efficacy and frequent, often severe, painful side effects in pooled analyses and systematic reviews; overall evidence indicates low efficacy for PDT in this dermatologic application with high rates of intolerable adverse effects.
Billing Codes and Coding Guidance
| No codes listed |
| 92235 | Fluorescein angiography (includes multiframe imaging) with interpretation and report. |
| J3396 | Injection, verteporfin, 0.1 mg |
| H35.30 - H35.32 | Macular degeneration, unspecified, non-exudative and exudative |
| H44.20 - H44.23 | Degenerative myopia [pathologic myopia] |
| H35.711 - H35.719 | Central serous retinopathy [serous chorioretinopathy] |
| D18.09 | Hemangioma of other sites [choroidal] |
| B39.4 - B39.9 | Histoplasmosis (must be billed with H32) |
| C44.01, C44.111 - C44.119, etc. | Basal cell carcinoma and other malignant neoplasms (listed as not covered for CPB indications) |
| No codes listed |
| No codes listed |
Prior Authorization, Documentation, and Clinical Workflow
Obtain prior authorization for verteporfin PDT and meet selection criteria
Prior authorization is required for photodynamic therapy (PDT) with verteporfin (Visudyne) and will be approved only when selection criteria are met (e.g., predominantly classic subfoveal CNV due to AMD, pathologic myopia, presumed ocular histoplasmosis, chronic CSC, or choroidal hemangioma and treatment spot size ≤ 6.4 mm). Relevant procedure and drug codes referenced in the policy include CPT 67221 and 67225 and HCPCS J3396 for verteporfin.
No explicit PA process or exhaustive code list stated in excerpts
The provided excerpts do not list a required prior authorization process or an exhaustive code list; providers should follow the payer's standard prior authorization channel and reference the policy indications and codes when requesting review.
- No explicit mandatory prior authorization process or comprehensive code list is stated in these document excerpts.
- Follow payer-specific prior authorization submission procedures and include the clinical documentation outlined in the policy.
Expect prior authorization for non‑standard (off‑label) indications
Prior authorization is expected when using PDT for indications beyond the FDA‑approved ocular uses (predominantly classic subfoveal CNV due to AMD, pathologic myopia, ocular histoplasmosis) because evidence for other indications is limited.
- Non‑standard ocular indications cited in the policy (e.g., angioid streaks, CSC, PCV, idiopathic CNV) generally require justification and prior authorization.
- Provide supporting evidence and rationale when requesting PDT for off‑label indications.
For PCV, document ICGA/GLD and rationale for PDT ± anti‑VEGF in PA
For polypoidal choroidal vasculopathy (PCV), prior authorization may require diagnostic confirmation (e.g., ICGA) and rationale for PDT ± intravitreal anti‑VEGF given evidence that combined therapy can be more effective than monotherapy.
- Document ICGA findings and greatest linear dimension (GLD) to guide laser spot sizing as part of the authorization request.
- If proposing combination therapy, include rationale and supporting literature given mixed evidence and potential investigational considerations.
PA likely required for investigational or limited‑evidence indications
Prior authorization is likely required for many nonstandard or investigational indications because evidence is limited to small trials, retrospective series, pilot studies, or preclinical data; requests should include justification and supporting literature.
- Provide study citations, case series data, or pilot study protocols if seeking approval for investigational or uncommon uses.
- Highlight prior therapies tried and specific lesion characteristics to support medical necessity.
No specific PA code requirements stated in this section
This segment does not specify particular prior authorization billing codes or enforcement mechanisms; refer to the full policy and payer prior authorization resources for submission details.
- Use the policy indications and coding table as supporting documentation when submitting a PA.
- Contact the payer for specific PA forms, portals, or fax requirements.
Administrative note — consult preceding policy parts for PA details
Administrative notes and external links appear in this part of the document only; consult earlier policy sections for explicit prior authorization requirements and submission instructions.
- This excerpt contains policy history and links; it does not replace the prior authorization guidance in preceding policy sections.
- Providers remain responsible for using the payer's official PA process.
No explicit step‑therapy sequencing requirements stated
No explicit step‑therapy algorithms or required sequencing are specified in these excerpts; clinical judgment and the related anti‑VEGF policy (CPB 0701) should guide treatment sequencing.
- When applicable, reference CPB 0701 (Vascular Endothelial Growth Factor Inhibitors for Ocular Indications) for anti‑VEGF sequencing.
- Document rationale when deviating from common sequencing (e.g., using PDT before anti‑VEGF).
Document prior treatments and rationale for PDT in CSC (step therapy context)
Focal laser and PDT are described as standard options for persistent subretinal fluid in central serous chorioretinopathy (CSC), but optimal timing and selection remain unclear — include prior treatments and rationale in the record.
- Document prior observation, medical therapy, or laser attempts when requesting PDT for CSC.
- Explain choice of standard vs reduced‑dose/fluenc e PDT protocols if used.
Prefer anti‑VEGF before PDT for myopic CNV; document rationale if PDT is first‑line
Clinical evidence favors intravitreal anti‑VEGF over verteporfin PDT as first‑line therapy for myopic CNV; if PDT is requested first‑line, document the clinical rationale and contraindications to anti‑VEGF.
- If anti‑VEGF was not tried, include reason (contraindication, intolerance, access issues) in the authorization request.
- Cite comparative studies or meta-analyses supporting anti‑VEGF preference when applicable.
Consider anti‑VEGF first or combined therapy for PCV; document prior therapy and rationale
For PCV, consider a step approach (anti‑VEGF first or combined therapy) based on lesion characteristics and clinical course; include prior anti‑VEGF response and justification for PDT in authorization documentation.
- Provide prior anti‑VEGF treatment history, BCVA trends, and imaging (ICGA/OCT) when proposing PDT for PCV.
- If proposing combination therapy, document timing (e.g., anti‑VEGF before or after PDT) and supporting evidence.
Document selection of half‑dose or combination PDT strategies and prior treatments
In pachychoroid/neovascular conditions (e.g., PNV, PPS), half‑dose or combination PDT strategies are reported; include prior treatments, dose/fluence chosen, and imaging rationale in the record.
- Document whether standard (6 mg/m2) or reduced‑dose/fluence PDT was used and the clinical reason for that choice.
- Include OCT/ICGA findings and prior anti‑VEGF therapy response when applicable.
No step‑therapy mandates stated in these excerpts — verify plan protocols
No step‑therapy requirements are stated in other segments of the policy; absence of requirements does not preclude payer‑specific protocols — verify with the payer.
- Confirm whether the member's plan has any step‑therapy or prior authorization prerequisites beyond this policy.
- Provide full clinical documentation to support medical necessity when no formal step pathway exists.
Document 3‑month re‑evaluation and imaging evidence to justify retreatment
Physician re‑evaluation is expected approximately 3 months after PDT; document FA or OCT evidence of recurrent or persistent leakage to support retreatment.
- Record the 3‑month follow‑up visit with BCVA and FA or OCT results indicating leakage status.
- If retreating, document that angiographic or OCT evidence justified repeat treatment at ~3‑month intervals.
Record BCVA and FA/ICGA/OCT (and US when applicable) at baseline and follow‑up
Include baseline and follow‑up clinical measures in records: best‑corrected visual acuity (BCVA), FA/ICGA/OCT imaging, and ultrasonography as applicable to assess anatomic and functional response to PDT.
- Capture BCVA using ETDRS or equivalent at baseline and follow‑up visits.
- Include FA, ICGA, and OCT images/reports to document lesion activity and response.
Include indication, BCVA, imaging, lesion measurements, dose, and PDT parameters in documentation
Required documentation for authorization or claim review should include indication, baseline BCVA, imaging evidence (OCT, FA, US as applicable), lesion measurements (thickness/diameter), verteporfin dose and PDT light parameters, and follow‑up outcome assessments.
- Specify verteporfin dosing (commonly 6 mg/m2) and the laser/light parameters used (e.g., wavelength, J/cm2, exposure time).
- Provide lesion size (GLD, diameter, thickness) and imaging used to determine laser spot sizing.
Provide ICGA and GLD measurement to justify PDT spot sizing for PCV
For PCV, document ICGA findings and calculation of greatest linear dimension (GLD) used to select laser spot diameter to support appropriate PDT planning and authorization.
- Include pre‑treatment ICGA images and method of GLD measurement.
- State the chosen laser spot diameter and any margin added to GLD per the study methods.
When documenting investigational pilot protocols, include infusion timing, dose, light delivery, and follow‑up imaging
Pilot study protocols (e.g., EUS‑guided VP‑PDT for pancreatic lesions) included procedural details such as infusion dose (0.4 mg/kg infused 60–90 minutes before procedure), light delivery (50 J/cm for 333 seconds), day‑2 CT for necrosis assessment, and AE monitoring on days 1, 2, and 14 — include these elements when documenting investigational use.
- For investigational/clinical‑trial applications, reference the pilot protocol specifics (dose, timing, light energy, imaging follow‑up) in requests.
- Report early imaging outcomes (e.g., day‑2 CT) and AE monitoring per study protocols when applicable.
Reference policy history and legal notice; confirm plan‑specific coverage
Policy history, review dates, and legal disclaimers are provided in the policy; Clinical Policy Bulletins are a partial description of plan benefits and do not constitute a contract — verify plan‑specific coverage determinations.
- Policy effective date: 03/08/2002; Last review: 06/29/2023; Next review: 04/25/2024.
- Coverage determinations may vary by plan and should be confirmed with the payer.
Provider responsibility — document clinical orders and responsibility
Providers are responsible for medical advice and treatment decisions and are independent contractors; include clinical responsibility statements and signed clinical interpretations in records as appropriate.
- Ensure supervising physician documentation and orders are present for PDT administration.
- Maintain complete clinical records supporting the medical necessity and safety of the procedure.
Do not expect coverage for indications listed as experimental/investigational
Use of Visudyne PDT for indications listed as experimental/investigational in the policy (e.g., alopecia areata, basal cell carcinoma, choroidal metastasis, parafoveal CNV, PCV, peri‑papillary pachychoroid syndrome, various cancers) will be denied as experimental/investigational; do not bill these as covered indications without prior approval.
- Refer to the policy's Experimental and Investigational list when considering PDT for non‑listed indications.
- Requests for these indications should include trial enrollment details or robust supporting evidence; coverage is not routine.
Claims for verteporfin (J3396) combined with intravitreal anti‑VEGF may be denied
Billing verteporfin (J3396) in combination with intravitreal anti‑angiogenic agents is noted as not covered in combination; claims billed for concurrent combination therapy may be denied.
- If planning combined administration, verify coverage and billing rules prior to treatment and document medical necessity and timing.
- Separate billing for sequential treatments should be clearly documented if applicable.
No other explicit authorization or denial triggers stated — still submit PA with full documentation
No explicit additional provider authorization requirements or payer denial triggers are specified in other excerpts; nonetheless, absence of explicit triggers does not eliminate the need for PA and thorough documentation when indicated.
- When in doubt, submit a prior authorization request with full documentation to mitigate denial risk.
- Include indication, prior treatments, imaging, and rationale for PDT in submissions.
Evidence limitations for non‑standard indications may lead to denial
Lack of randomized controlled trial evidence for many non‑standard ocular indications (e.g., angioid streaks, CSC, choroidal hemangioma in some series) may lead to denial or limited coverage when used outside approved indications.
- Include case‑series outcomes and specific patient factors when requesting coverage for non‑standard indications to justify medical necessity.
- Acknowledge limitations of the evidence and explain why PDT is appropriate for the individual member.
Use for 100% occult CNV (no classic component) lacks demonstrated benefit — denial risk
PDT for 100% occult CNV (no classic component) showed no benefit in a randomized study and the EMEA rescinded approval for that indication; use in purely occult lesions may be denied for lack of demonstrated benefit.
- If proposing PDT for occult CNV without a classic component, provide compelling justification and supportive data; routine coverage is not supported.
- Document lesion subtype and reference the negative randomized trial when relevant.
Guideline omission (e.g., NCCN) may increase denial risk for oncologic uses
Absence of verteporfin/PDT in authoritative guidelines (e.g., NCCN for pancreatic adenocarcinoma) may increase the risk of denial for such oncologic indications; investigational oncology uses generally require PA and strong justification.
- For pancreatic or other oncologic indications, include pilot study data and explain why standard therapies are unsuitable.
- Anticipate coverage denial without enrollment in a clinical trial or substantial supporting evidence.
Coverage disclaimer — verify member‑specific coverage and obtain PA
The policy states that Clinical Policy Bulletins describe benefits but do not constitute a contract; coverage determinations may vary by plan — confirm benefits for the specific member and plan.
- Verify member eligibility and plan benefit language before scheduling PDT.
- Obtain prior authorization when indicated to reduce financial and claim denial risk.
Background and Scope
Visudyne (verteporfin) is a light‑activated photosensitizer used in photodynamic therapy to occlude pathologic neovasculature by generation of reactive oxygen species when activated by light. The FDA‑labeled dosing commonly used is intravenous verteporfin at 6 mg/m2 followed by activation with a 689 nm laser; clinical protocols and labeling also describe re‑evaluation at approximately 3 months and retreatment intervals guided by angiographic or OCT evidence of persistent or recurrent leakage.
Key Definitions and Terms
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