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Photodynamic therapy is a treatment modality designed to selectively occlude ocular choroidal neovascular tissue. The therapy is a 2-step process, consisting initially of an injection of the photosensitizer verteporfin, followed 15 minutes later by laser treatment to the targeted sites of neovascularization in the retina. The laser treatment selectively damages the vascular endothelium. Patients may be re-treated if leakage from choroidal neovascularization persists.
There is currently one (1) intravenous photodynamic therapy agent that has received approval by the U.S. Food and Drug Administration (FDA) for treatment of choroidal neovascularization: verteporfin (Visudyne™). While choroidal neovascularization may be associated with a wide variety of ophthalmologic conditions, the labeled indications include predominantly classic subfoveal choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, and presumed ocular histoplasmosis. The FDA-labeled indications note that there is insufficient evidence for verteporfin (Visudyne™) use in predominately occult subfoveal choroidal neovascularization and it is contraindicated in patients with prophyria.
Prior to the availability of photodynamic therapy, choroidal neovascularization was treated with photocoagulation using either argon, green, or infrared lasers. This conventional photocoagulation was limited to extrafoveal lesions due to the risk of retinal burns. However, recently, infrared lasers used at a low-power setting have been investigational as a technique to photocoagulate subfoveal lesions. This therapy is addressed in the Transpupillary Thermotherapy for Treatment of Choroidal Neovascularization medical policy.
Age-Related Macular Degeneration
Age-related macular degeneration (ARMD) is a painless, insidious process. In its earliest stages, it is characterized by minimal visual impairment and the presence of large drusen and other pigmentary abnormalities on ophthalmoscopic examination. As ARMD progresses, two (2) distinctively different forms of degeneration may be observed. The first, called the atrophic or areolar or dry form, evolves slowly. Atrophic ARMD is the most common form of degeneration and is often a precursor of the second form, the more devastating exudative neovascular form, also referred to as disciform or wet degeneration. The wet form is distinguished from the atrophic form by serous or hemorrhagic detachment of the retinal pigment epithelium and the development of choroidal neovascularization (CNV), sometimes called neovascular membranes. Risk of developing severe irreversible loss of vision is greatly increased by the presence of CNV. The pattern of CNV, as revealed by fluorescein or indocyanine angiography, is further categorized as classic or occult. For example, classic CNV appears as an initial lacy pattern of hyperfluorescence followed by more irregular patterns as the dye leaks into the subretinal space. Occult CNV lacks the characteristic angiographic pattern, either due to the opacity of coexisting subretinal hemorrhage or, especially in CNV associated with ARMD, by a tendency for epithelial cells to proliferate and partially or completely surround the new vessels. Interestingly, lesions consisting only of classic CNV carry a worse visual prognosis than those made up of only occult CNV, suggesting that the proliferative response that obscures new vessels may also favorably alter the clinical course of ARMD.
Polypoidal Choroidal Vasculopathy
Polypoidal choroidal vasculopathy arises primarily due to abnormal choroidal circulation, resulting in characteristic lesions comprising well-defined vascular networks of vessels ending in polyp-like structures. A less common subtype is polypoidal CNV, and it may be considered a subtype of AMD. Eyes that develop a cluster of grape-like polypoidal dilations are at high risk for severe vision loss.
Presumed Ocular Histoplasmosis
Presumed ocular histoplasmosis may be the second most common cause of blindness in patients younger than 50 years of age in certain endemic areas. It is a condition characterized by a positive skin test for histoplasmosis, military opacities of the lungs, tiny choroidal scars, peripapillary disruption of the choriocapillaris, and exudation or hemorrhage form choroidal lesions in or near the macula. The condition is asymptomatic and benign, unless the choroidal neovascular lesions, which may develop many years after choroiretinal scarring has taken place, affect the macula.
Pathologic myopia refers to an abnormal elongation of the eye associated with severe near-sightedness. It generally occurs among people over 30 years of age and can result in progressive, severe loss of vision, frequently related to the development of CNV.
Central Serous Chorioretinopathy
Central serous chorioretinopathy refers to 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. Central serous chorioretinopathy may resolve spontaneously or can be treated with medication and laser photocoagulation.
Choroidal hemangioma is an uncommon, benign vascular tumor, manifesting as an orange-red mass in the posterior pole of the eye. Visual loss may be progressive and irreversible because of chronic foveal detachment.
Angioid streaks are dehiscences in Bruch’s membrane and occur in patients with some systemic diseases such as pseudoxanthoma elasticum, Paget’s disease of bone, or sickle hemoglobinopathy. Vision loss in eyes with angioid streaks occurs most frequently as a result of CNV.
CNV can occur as a complication of inflammatory conditions such as uveitis, multifocal choroiditis, and panuveitis, and punctate inner choroidopathy. About one-third of patients develop choroidal neovascularization, which can result in severe vision loss if it is subfoveal.
Other Treatments for Age-Related Macular Degeneration
Other available therapeutic options for ARMD not addressed in this policy include antioxidants, thermal laser photocoagulation and vascular endothelial growth factor (VEGF) antagonists or angiostatics. The role for each varies according to location and ARMD subclassification. For those whose visual losses impair their ability to perform daily tasks, low-vision rehabilitative services offer resources to compensate for deficits.
Angiostatic agents block some stage in the pathway leading to new blood vessel formation (angiogenesis). Contrasting palliative treatments for CNV (e.g. thermal photocoagulation and photodynamic therapy), they are potentially disease modifying. Drugs currently under study target various parts of the angiogenic pathway: messenger RNA; vascular endothelial growth factors (VEGFs); endothelial cell proliferation, migration, and proteolysis. Pegaptanib (Macugen®) is presently the only angiostatic drug FDA-approved for use in ARMD. Pegaptanib binds extracellular VEGF to inhibit the angiogenesis pathway and is administered by intravitreous injections every 4-6 weeks.
(Avastin, Genentech) has been used off-label to treat AMD. It is derived from the same murine monoclonal antibody precursor as ranibizumab and is approved by the FDA for the treatment of metastatic cancer of the colon or rectum.
Also, see the related medical policy, Photocoagulation of Macular Drusen.
POLICYPhotodynamic therapy (PDT) as monotherapy may be considered medically necessary as a treatment of choroidal neovascularization associated with age-related macular degeneration, chronic central serous chorioretinopathy, choroidal hemangioma, pathologic myopia, or presumed ocular histoplasmosis.
Photodynamic therapy is considered investigational, as monotherapy for other ophthalmologic disorders, including choroidal neovascularization secondary to central serous chorioretinopathy.
Photodynamic therapy is considered investigational when used in combination with one or more of the anti-vascular endothelial growth factor therapies (anti-VEGF), i.e., pegatanib (Macugen®), ranibizumab (Lucentis®), bevacizumab (Avastin®), and aflibercept (Eylea™) as a treatment of CNV associated with age-related macular degeneration, pathologic myopia, presumed ocular histoplasmosis, or for other ophthalmologic disorders, including CNV secondary to central serous chorioretinopathy.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
A single payment will be made for OPT with verteporfin performed on both eyes on the same day, as a single infusion is adequate for treatment of both eyes.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/2000: Approved by Medical Policy Advisory Committee (MPAC), CPT 67299, 92235, 92250 added, ICD-9 diagnosis 362.52 added, HCPCS J3490 added
1/17/2001: Code Reference section updated, CPT 67221 added
7/3/2001: Code Reference section updated; ICD-9 procedure code 14.24 deleted, HCPCS G0184 deleted, ICD-9 procedure code 14.29 added, HCPCS G0183 added
9/5/2001: Pathologic myopia and presumed ocular histoplasmosis added as covered indications
3/12/2002: New 2002 codes added, CPT 67225 added, HCPCS J3395, J7308, Q3013 added
5/2/2002: Type of Service and Place of Service deleted
9/2/2004: Code Reference section updated, CPT 67225 description revised, ICD-9 diagnosis code 115.92, 360.21 added, ICD-9 diagnosis code 362.52 description revised, CPT 67299, 92235, 92250 deleted, HCPCS G0183, J3490, J7308, Q3013 deleted
2/18/2005: HCPCS J3395 deletion date added, HCPCS J3396 added with a Note: "Indicate the number of units the patient receives. A unit is defined as 0.1 milligrams by this code."
3/17/2006: Policy reviewed, no changes
4/21/2006: Policy revised
5/21/2007: Policy reviewed, no changes
6/24/2008: Policy reviewed, no changes
12/30/2010: Policy description updated to add information regarding Bevacizumab. Added link to related medical policy. Policy statement revised to add "monotherapy" to the first investigational policy statement. Added the following investigational policy statement: Photodynamic therapy is considered investigational when used in combination with one or more of the anti-vascular endothelial growth factor therapies (anti-VEGF), i.e., pegatanib (Macugen®), ranibizumab (Lucentis®), bevacizumab (Avastin®), as a treatment of CNV associated with age-related macular degeneration, pathologic myopia, presumed ocular histoplasmosis, or for other ophthalmologic disorders, including CNV secondary to central serous chorioretinopathy. FEP verbiage added to the Policy Exceptions section.
06/22/2011: Policy description and statement unchanged. Deleted "Subfoveal" from the title. Removed outdated references from the Sources section.
07/12/2012: Added aflibercept (Eylea™) as investigational when used in combination with photodynamic therapy.
09/25/2012: Policy description updated regarding treated conditions. Added "as monotherapy" to the medically necessary policy statement for clarity purposes. Added chronic central serous chorioretinopathy, choroidal hemangioma to the medically necessary policy statement. Added ICD-9 codes 228.09 and 362.41 to the Covered Codes table.
10/23/2013: Policy reviewed; no changes to policy statement. Removed deleted HCPCS code J3395 from the Code Reference section.
SOURCE(S)Blue Cross Blue Shield policy #9.03.08
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.