Commercial

Medical Policy

Notification

Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®)

Notification Issue Date:

The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®).

Title:

Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®)

Policy #:

07.13.05m

Policy

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

Photodynamic therapy (PDT) using verteporfin (Visudyne) as monotherapy is considered medically necessary and, therefore, covered for the treatment of choroidal neovascularization (CNV) associated with any of the following conditions:

Wet age-related macular degeneration (AMD)
Choroidal hemangioma
Chronic central serous chorioretinopathy
Pathologic myopia
Presumed ocular histoplasmosis

Prior to beginning treatment with PDT with verteporfin (Visudyne), a fluorescein angiogram shall be performed, by a licensed healthcare professional, to determine the area of the lesion. The licensed healthcare professional shall re-evaluate the individual every 3 months using a fluorescein angiogram or optical coherence tomography (OCT) to determine if further treatment is necessary. Retreatment is necessary if the fluorescein angiogram or the optical coherence tomography shows any signs of persistence or recurrence of leakage. Subsequent treatments may be needed until all leakage ceases. The fluorescein angiogram or optical coherence tomography shall be maintained in the individual's medical record and be available upon request.

All other uses for PDT using verteporfin (Visudyne) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

The use of PDT with verteporfin (Visudyne) in combination with any antivascular endothelial growth factor (VEGF) therapies (i.e., pegaptanib [Macugen], ranibizumab [Lucentis], bevacizumab [Avastin], aflibercept [Eylea]) for the treatment of CNV associated with AMD, choroidal hemangioma, chronic central serous chorioretinopathy, pathologic myopia, or presumed ocular histoplasmosis is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, photodynamic therapy (PDT) using verteporfin (Visudyne) is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for PDT using verteporfin (Visudyne).

Description

Photodynamic therapy (PDT) is a medical procedure that involves the administration of a photosensitive (light-activated) drug with a very specific absorption peak. This drug is chemically designed to have a unique affinity for the diseased tissue intended for treatment. Once introduced into the body, the drug accumulates and is retained in diseased tissue to a greater degree than in normal tissue. The administration of this photosensitive drug is followed by the targeted irradiation of the tissue with a nonthermal laser, which is calibrated to emit light at a wavelength that corresponds to the drug's absorption peak. This activates the drug, enabling it to locally treat the diseased tissue without affecting surrounding normal tissue. Currently, there are several forms of PDT available, one of which is PDT using verteporfin (Visudyne). PDT using verteporfin (Visudyne) is a US Food and Drug Administration (FDA)–approved treatment option for individuals with choroidal neovascularization (CNV) lesions due to age-related macular degeneration (AMD), presumed ocular histoplasmosis, or pathologic myopia.

Ocular diseases such as AMD, presumed ocular histoplasmosis, and pathologic myopia are associated with the growth of abnormal blood vessels in the choroid of the eye, also known as CNV. The presence of CNV can lead to severe, irreversible vision loss. PDT using verteporfin (Visudyne) is designed to selectively occlude ocular choroidal neovascular tissue. Verteporfin (Visudyne) is injected into the eye and is followed by laser treatment to the targeted sites of neovascularization in the retina, damaging the vascular endothelium.

AMD is a common eye condition and, in its earliest stages, is characterized by minimal visual impairment and the presence of large drusen and other pigmentary abnormalities on ophthalmoscopic examination. There are two types of AMD: atrophic (dry) AMD and exudative (wet) AMD. Atrophic AMD evolves slowly, is the most common form of AMD, and is characterized by small yellow lipid debris deposits beneath the retina. It is often a precursor of exudative AMD. The exudative form is distinguished from the atrophic form by serous or hemorrhagic detachment of the retinal pigment epithelium and the development of CNV. The three lesion types associated with exudative AMD are classic, occult, and minimally classic. In addition to PDT, available treatment options for AMD include thermal laser photocoagulation, corticosteroids, and vascular endothelial growth factor (VEGF) antagonists or angiostatics. The safety and effectiveness of each treatment depends on the form and location of the neovascularization.

Other conditions for which PDT with verteporfin (Visudyne) is FDA-approved are CNV lesions due to presumed ocular histoplasmosis and pathologic myopia. Presumed ocular histoplasmosis is a condition characterized by a positive skin test for histoplasmosis, miliary opacities of the lungs, tiny choroidal scars, peripapillary disruption of the choriocapillaris, and exudation or hemorrhage from choroidal lesions in or near the macula. The condition is generally benign and the individual asymptomatic unless CNV lesions, which may develop many years after chorioretinal scarring has taken place, affect the macula. Pathologic myopia refers to an abnormal elongation of the eye. The stretching of the sclera and retina of the eye can cause areas of atrophy and/or cracks in the retina, causing a leakage of blood. Pathologic myopia is associated with severe near-sightedness and can result in a progressive, severe loss of vision related to the development of CNV.

In addition to the conditions that have received FDA approval, the use of PDT using verteporfin (Visudyne) is currently supported in the treatment of CNV associated with choroidal hemangioma and chronic central serous chorioretinopathy, two rare conditions. Choroidal hemangioma is an uncommon, benign, vascular tumor, manifesting an orange-red mass in the posterior pole of the eye. Visual loss may be progressive and irreversible because of chronic foveal detachment. Based on a review of published literature, several case series demonstrated encouraging visual and anatomical outcomes with choroidal hemangioma treated with various PDT regimens. Central serous chorioretinopathy is an idiopathic disease in which there is a serous detachment of the macula due to leakage of fluid from the choriocapillaris through the retinal pigment epithelium. This condition is avascular; however, neovascularization can occur as a secondary complication. Reduced dose PDT may result in improved anatomical outcomes for acute central serous chorioretinopathy, but clinically significant improvements in visual acuity have not been shown. Recent studies of reduced-dose PDT and reduced fluence for chronic central serous chorioretinopathy suggest a possible beneficial effect of this treatment.

PDT using verteporfin (Visudyne) is proposed in the treatment of CNV due to other conditions, including angioid streaks and inflammatory eye conditions. For angioid streaks, a 2010 systematic review concluded that PDT might limit or slow vision loss compared with the expected natural course of CNV due to angioid streaks, but one study showed a decrease in visual acuity following PDT, and others showed that substantial numbers of individuals continued to lose visual acuity. Further studies are warranted to further assess PDT's long-term safety and effectiveness for the use of verteporfin (Visudyne) in the treatment of CNV due to angioid streaks. The same systematic review noted that encouraging visual and anatomical outcomes have been reported with inflammatory eye conditions such as punctate inner choroidopathy, choroiditis and toxoplasmic retinochoroiditis, and subfoveal CNV due to posterior uveitis. Larger and comparative studies are necessary to evaluate the effect of PDT on health outcomes for CNV associated with inflammatory eye conditions.

In addition to the use of verteporfin (Visudyne) as monotherapy for the treatment of CNV, clinical research on the use of PDT concurrently or sequentially with pharmacologic therapy using anti-VEGF agents (i.e., pegatanib [Macugen], ranibizumab [Lucentis], bevacizumab [Avastin], aflibercept [Eylea]) continues to be under investigation. Whether this combination therapy has an effect on health outcomes for individuals with conditions such as AMD, pathologic myopia, or presumed histoplasmosis has yet to be determined.

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Coding

CPT Procedure Code Number(s)

67221, 67225

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

B39.3 Disseminated histoplasmosis capsulati

B39.4 Histoplasmosis capsulati, unspecified

B39.5 Histoplasmosis duboisii

B39.9 Histoplasmosis, unspecified

D18.09 Hemangioma of other sites

H32 Chorioretinal disorders in diseases classified elsewhere

H35.051 Retinal neovascularization, unspecified, right eye

H35.052 Retinal neovascularization, unspecified, left eye

H35.053 Retinal neovascularization, unspecified, bilateral

H35.3210 Exudative age-related macular degeneration, right eye, stage unspecified

H35.3211 Exudative age-related macular degeneration, right eye, with active choroidal neovascularization

H35.3212 Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization

H35.3213 Exudative age-related macular degeneration, right eye, with inactive scar

H35.3220 Exudative age-related macular degeneration, left eye, stage unspecified

H35.3221 Exudative age-related macular degeneration, left eye, with active choroidal neovascularization

H35.3222 Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization

H35.3223 Exudative age-related macular degeneration, left eye, with inactive scar

H35.3230 Exudative age-related macular degeneration, bilateral, stage unspecified

H35.3231 Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization

H35.3232 Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization

H35.3233 Exudative age-related macular degeneration, bilateral, with inactive scar

H35.711 Central serous chorioretinopathy, right eye

H35.712 Central serous chorioretinopathy, left eye

H35.713 Central serous chorioretinopathy, bilateral

H44.21 Degenerative myopia, right eye

H44.22 Degenerative myopia, left eye

H44.23 Degenerative myopia, bilateral

H44.2A1 Degenerative myopia with choroidal neovascularization, right eye

H44.2A2 Degenerative myopia with choroidal neovascularization, left eye

H44.2A3 Degenerative myopia with choroidal neovascularization, bilateral

H44.2B1 Degenerative myopia with macular hole, right eye

H44.2B2 Degenerative myopia with macular hole, left eye

H44.2B3 Degenerative myopia with macular hole, bilateral

H44.2C1 Degenerative myopia with retinal detachment, right eye

H44.2C2 Degenerative myopia with retinal detachment, left eye

H44.2C3 Degenerative myopia with retinal detachment, bilateral

H44.2D1 Degenerative myopia with foveoschisis, right eye

H44.2D2 Degenerative myopia with foveoschisis, left eye

H44.2D3 Degenerative myopia with foveoschisis, bilateral

H44.2E1 Degenerative myopia with other maculopathy, right eye

H44.2E2 Degenerative myopia with other maculopathy, left eye

H44.2E3 Degenerative myopia with other maculopathy, bilateral

HCPCS Level II Code Number(s)

J3396 Injection, verteporfin, 0.1 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 07.13.05m:

03/04/2026	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®).
11/17/2025	This version of the policy will become effective 11/17/2025. The following ICD-10 Diagnosis codes have been removed from this policy: H35.059, H35.3290, H35.3291, H35.3292, H35.3293, H35.719, H44.20, H44.2A9, H44.2B9, H44.2C9, H44.2D9, H44.2E9.

Revisions From 07.13.05l:

10/01/2024

This policy has been identified for an ICD-10 code update, effective 10/01/2024.

The following ICD-10 code narratives have been revised:

H44.2A3 Degenerative myopia with choroidal neovascularization, bilateral

H44.2B3 Degenerative myopia with macular hole, bilateral

H44.2C3 Degenerative myopia with retinal detachment, bilateral

H44.2D3 Degenerative myopia with foveoschisis, bilateral

H44.2E3 Degenerative myopia with other maculopathy, bilateral

Revisions From 07.13.05k:

06/12/2024	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®).
06/14/2023	The policy has been reviewed and reissued to communicate the Company’s continuing position on photodynamic therapy (PDT) using verteporfin (Visudyne®).
06/15/2022	The policy has been reviewed and reissued to communicate the Company’s continuing position on photodynamic therapy (PDT) using verteporfin (Visudyne®).
06/16/2021	This policy has been reissued in accordance with the Company's annual review process.
11/18/2020	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®).
07/03/2019	The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®).
05/07/2018	This policy has undergone a routine review, and the following diagnosis codes have been added to this policy: B39.3, H32, H35.059, H35.719, H44.20, H44.2B1, H44.2B2, H44.2B3, H44.2B9, H44.2C1, H44.2C2, H44.2C3, H44.2C9, H44.2D1, H44.2D2, H44.2D3, H44.2D9, H44.2E1, H44.2E2, H44.2E3, H44.2E9

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

11/17/2025

Version Issued Date:

11/17/2025

Version Reissued Date:

3/4/2026