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Photodynamic therapy (PDT) 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, thereby occluding choroidal neovascularization tissue. Patients may be re-treated if leakage from choroidal neovascularization (CNV) persists.
Severe vision loss can occur with ocular neovascularization, the growth of abnormal blood vessels in the retina or choroid. Neovascularization occurs in a number of ocular diseases, including age-related macular degeneration (AMD). Available therapeutic options for CNV include PDT, antioxidants, thermal laser photocoagulation, corticosteroids, and vascular endothelial growth factor (VEGF) antagonists or angiostatics. The safety and efficacy of each treatment depends on the form and location of the neovascularization. For those whose visual losses impair their ability to perform daily tasks, low-vision rehabilitative services offer resources to compensate for deficits.
Before 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. Introduction of a scotoma or enlargement of a preexisting scotoma, with or without visual acuity loss, is an immediate and permanent effect of photocoagulation surgery. Because of the loss of vision associated with laser photocoagulation, photocoagulation is no longer recommended as the initial treatment of subfoveal neovascularization. More recently, infrared lasers used at a low-power setting have been investigated as a technique to photocoagulate subfoveal lesions. This therapy is addressed in the Transpupillary Thermotherapy for Treatment of Choroidal Neovascularization medical policy.
Combining PDT with angiostatic agents, concurrently or sequentially, has a biologic basis and is under active investigation. Angiostatic agents block some stage in the pathway leading to new blood vessel formation (angiogenesis). Drugs currently under study target various parts of the angiogenic pathway: messenger RNA; VEGFs; endothelial cell proliferation, migration, and proteolysis. The angiostatic agents being studied in trials include pegaptanib, ranibizumab, bevacizumab, anecortave acetate, squalamine, vatalanib, and triamcinolone acetonide. In contrast to palliative treatments for CNV (eg, thermal photocoagulation, PDT), these drugs are potentially disease modifying because they inhibit development of newly formed vessels.
Intravitreal triamcinolone acetonide was one of the first pharmacologic compounds evaluated for the treatment of CNV secondary to AMD. The most important effects of this treatment consist of the stabilization of the blood-retinal barrier and the down-regulation of inflammation. Triamcinolone acetonide also has antiangiogenic and antifibrotic properties and remains active for months after intravitreal injection.
Age-Related Macular Degeneration
Age-related macular degeneration (AMD) 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 AMD progresses, two (2) distinctively different forms of degeneration may be observed. The first, called the atrophic or areolar or dry form, evolves slowly. Atrophic AMD 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 AMD, 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 AMD.
Pathologic myopia refers to an abnormal elongation of the eye associated with severe near-sightedness. It generally occurs among people older than 30 years of age and can result in progressive, severe loss of vision, frequently related to the development of CNV.
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 (Ohio and Mississippi River valleys in the United States). This condition is 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.
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. Although central serous chorioretinopathy often resolves spontaneously in 3 to 4 months, chronic or recurrent central serous chorioretinopathy can result in progressive decline of visual acuity. Central serous chorioretinopathy has been treated with medication and laser photocoagulation, but these treatments have limited efficacy.
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.
Polypoidal Choroidal Vasculopathy
Polypoidal choroidal vasculopathy arises primarily from 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.
Angioid streaks are dehiscences in Bruch membrane and occur in patients with some systemic diseases such as pseudoxanthoma elasticum, Paget 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.
In 2000, verteporfin (Visudyne®, Novartis), an intravenous photodynamic therapy agent, was approved by the FDA through the premarket approval process for the treatment of predominantly classic subfoveal CNV due to AMD, pathologic myopia, and presumed ocular histoplasmosis. The label notes that there is insufficient evidence for verteporfin use in predominately occult subfoveal CNV, and it is contraindicated in patients with porphyria.
This policy addresses combined treatment with PDT and VEGF inhibitors. Treatment of choroidal neovascularization with VEGF monotherapy is addressed separately in the Intravitreal Angiogenesis Inhibitors for Choroidal Vascular Conditions medical policy. Also see the related medical policy for 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.
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, chronic central serous chorioretinopathy, choroidal hemangioma, pathologic myopia, presumed ocular histoplasmosis, or for other ophthalmologic disorders.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
FDA labeling for verteporfin indicates that the physician should re-evaluate the patient every 3 months and, if CNV leakage is detected on fluorescein angiography, therapy should be repeated. However, the total number of treatments is not addressed by FDA. Evidence defining when treatment should stop is not available, but experts have suggested stopping “when the situation is judged to be ‘futile’." FDA labeling states “safety and efficacy of Visudyne beyond 2 years have not been demonstrated.”
Acute central serous chorioretinopathy refers to self-limiting disease that resolves spontaneously over a few months without any treatment. Chronic central serous chorioretinopathy has been defined as a serous macular elevation, visible biomicroscopically or detected by optical coherence tomography, that is associated with retinal pigment epithelial atrophic areas and subtle leaks or ill-defined staining by fluorescein angiography, and which does not resolve spontaneously within a few months.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/12/2014: Policy reviewed; description updated. First investigational statement revised to remove "including choroidal neovascularization secondary to central serous chorioretinopathy." It previously stated: Photodynamic therapy is considered investigational, as monotherapy for other ophthalmologic disorders, including choroidal neovascularization secondary to central serous chorioretinopathy. Second investigational statement revised to add "chronic central serous chorioretinopathy, choroidal hemangioma" and remove "including CNV secondary to central serous chorioretinopathy." It previously stated: 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 guidelines updated to add FDA labeling information for verteporfin and to define acute and chronic central serous chorioretinopathy.
08/27/2015: Code Reference section updated for ICD-10.
10/28/2015: Policy reviewed. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
04/22/2016: Policy description updated. Policy statements unchanged.
05/27/2016: Policy number A.9.03.08 added.
09/30/2016: Code Reference section updated to add the following new ICD-10 diagnosis codes: H35.3210 - H35.3293.
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.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.