Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®)

Policy #:07.13.05k

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

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.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

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 three 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 anti-vascular 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 photodynamic therapy (PDT) using verteporfin (Visudyne®). PDT using verteporfin (Visudyne®) is a United States Food and Drug Administration (FDA)--approved treatment option for individuals with choroidal neovascularization (CNV) lesions due to 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 itself as 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 angoid 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 angoid streaks. The same systematic review noted encouraging visual and anatomical outcomes have been reported with inflammatory eye conditions such as punctuate inner choroidopathy, choroiditis and toxoplasmic retinochoroiditis, and subfoveal CNV due to posterior uveitis. Larger and comparative studies are necessary in order 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.
References


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Rubin GS, Bressler NM. Effects of verteporfin therapy on contrast sensitivity: results from the treatment of age-related macular degeneration with photodynamic therapy (TAP) investigation--TAP Report no. 4. Retina. 2002;22(5):536-544.

Rudnisky CJ, Liu C, Ng M, et al. Intravitreal bevacizumab alone versus combined verteporfin photodynamic therapy and intravitreal bevacizumab for choroidal neovascularization in age-related macular degeneration: visual acuity after 1 year of follow-up. Retina. 2010;30(4):548-54.

Salehi M, Wenick AS, Law HA, et al. Interventions for central serous chorioretinopathy: a network meta analysis. Cochrane Database Syst Rev. 2015;12:CD011841.

Schmidt-Erfurth U, Sacu S; Early Retreatment Study Group. Randomized multicenter trial of more intense and standard early verteporfin treatment of neovascular age-related macular degeneration. Ophthalmology. 2008;115(1):134-140.

Semeraro F, Romano MR, Danzi P, et al. Intravitreal bevacizumab versus low-fluence photodynamic therapy for treatment of chronic central serous chorioretinopathy. Jpn J Ophthalmol. 2012;56(6):608-612.

Semeraro F, Russo A, Delcassi L, et al. Treatment of exudative age-related macular degeneration with ranibizumab combined with ketorolac eyedrops or photodynamic therapy. Retina. 2015;35(8):1547-1554.

Senturk F, Karacorlu M, Ozdemir H, et al. Microperimetric changes after photodynamic therapy for central serous chorioretinopathy. Am J Ophthalmol. 2011;151(2):303-309.

Shin JY, Woo SJ, Yu HG, et al. Comparison of efficacy and safety between half-fluence and full-fluence photodynamic therapy for chronic central serous chorioretinopathy. Retina. 2011;31(1):119-126.

Tang K, Si JK, Guo DD, et al. Ranibizumab alone or in combination with photodynamic therapy vs photodynamic therapy for polypoidal choroidal vasculopathy: a systematic review and Meta-analysis. Int J Ophthalmol. 2015;8(5):1056-1066.

Tong Y, Zhao KK, Feng D, et al. Comparison of the efficacy of anti-VEGF monotherapy versus PDT and intravitreal anti-VEGF combination treatment in AMD: a Meta-analysis and systematic review. Int J Ophthalmol. 2016;9(7):1028-1037.

Treatment of age-related macular degeneration with photodynamic therapy (TAP) Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials--TAP report. Arch Ophthalmol. 1999;117(10):1329-1345.

Uetani R, Ito Y, Oiwa K, et al. Half-dose vs one-third-dose photodynamic therapy for chronic central serous chorioretinopathy. Eye (Lond). 2012;26(5):640-649.

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Vedula SS, Krzystolik MG. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration. Cochrane Systematic Rev. 2008;(2):CD005139.

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Verteporfin in Photodynamic Therapy (VIP) Study Group. Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin. 1-year results of a randomized clinical trial--VIP report no. 1. Opthalmology. 2001;108(5):841-852.

Verteporfin in Photodynamic Therapy (VIP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization: two-year results of a randomized clinical trial including lesions with occult with no classic choroidal neovascularization--verteporfin in photodynamic therapy report 2. Am J Ophthalmol. 2001;131(5):541-560.

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Zhao M, Zhang F, Chen Y, et al. A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial. JAMA Ophthalmol. 2015;133(3):333-340.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

67221, 67225


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

H35.059 Retinal neovascularization, unspecified, unspecified eye

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

H35.3290 Exudative age-related macular degeneration, unspecified eye, stage unspecified

H35.3291 Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization

H35.3292 Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization

H35.3293 Exudative age-related macular degeneration, unspecified eye, with inactive scar

H35.711 Central serous chorioretinopathy, right eye

H35.712 Central serous chorioretinopathy, left eye

H35.713 Central serous chorioretinopathy, bilateral

H35.719 Central serous chorioretinopathy, unspecified eye

H44.20 Degenerative myopia, unspecified eye

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 eye

H44.2A9 Degenerative myopia with choroidal neovascularization, unspecified eye

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 eye

H44.2B9 Degenerative myopia with macular hole, unspecified eye

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 eye

H44.2C9 Degenerative myopia with retinal detachment, unspecified eye

H44.2D1 Degenerative myopia with foveoschisis, right eye

H44.2D2 Degenerative myopia with foveoschisis, left eye

H44.2D3 Degenerative myopia with foveoschisis, bilateral eye

H44.2D9 Degenerative myopia with foveoschisis, unspecified eye

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 eye

H44.2E9 Degenerative myopia with other maculopathy, unspecified eye



HCPCS Level II Code Number(s)

J3396 Injection, verteporfin, 0.1 mg


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 07.13.05k:
07/03/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Photodynamic Therapy (PDT) Using Verteporfin (Visudyne®).
05/07/2018This 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: 05/07/2018
Version Issued Date: 05/07/2018
Version Reissued Date: 07/03/2019

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