| MP 9.03.08 | Photodynamic Therapy for Subfoveal Choroidal Neovascularization | |
| Medical Policy | ||
| Section Miscellaneous Policies |
Original Policy Date 12/15/01 |
Last Review Status/Date Reviewed with literature search/6:2008 |
| Issue 6:2008 |
Return to Medical Policy Index |
Disclaimer
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Description
Photodynamic Therapy
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 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 use in predominately occult subfoveal choroidal neovascularization, and it is contraindicated in patients with porphyria.
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 a separate policy and is referred to as Transpupillary Thermotherapy for Treatment of Choroidal Neovascularization (policy No. 9.03.10 ).
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 AMD progresses, 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.
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 (the Ohio and Mississippi River valleys in the U.S.). It 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 asymptomatic and benign, unless the choroidal neovascular lesions, which may develop many years after chorioretinal scarring has taken place, affect the macula.
Pathologic Myopia
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 a 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.
Other Treatments for Age-Related Macular Degeneration
Other available therapeutic options for AMD not addressed in this policy include antioxidants, thermal laser photocoagulation (see policy No. 9.03.10 on Transpupillary Thermotherapy), and vascular endothelial growth factor [VEGF] antagonists or angiostatics (See policy No. 9.03.16 on Anecortave Acetate). The role for each varies according to location and AMD 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®, Eyetech and Pfizer) and ranibizumab (Lucentis™, Genentech) are presently the only angiostatic drugs FDA-approved for use in AMD. Pegaptanib and ranibizumab bind extracellular VEGF to inhibit the angiogenesis pathway and are administered by intravitreous injections every 4-6 weeks.
Bevacizumab (Avastin, Genentech) has been used off-label to treat ARMD. It is derived from the same murine monoclonal antibody precursor as ranibizumab and is FDA-approved for the treatment of metastatic cancer of the colon or rectum.
Other treatments for age-related macular degeneration are addressed in policies 9.03.10 (transpupillary thermotherapy) and 9.03.11 (photocoagulation of macular drusen).
Policy
Photodynamic therapy may be considered medically necessary as a treatment of choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.
Photodynamic therapy is considered investigational for other ophthalmologic disorders, including choroidal neovascularizationsecondary to central serous chorioretinopathy.
Policy Guidelines
The U.S. Food and Drug Administration (FDA) labeling for verteporfin indicates that the physician should re-evaluate the patient every 3 months and, if choroidal neovascular leakage is detected on fluorescein angiography, therapy should be repeated. However, the total number of treatments is not addressed by the FDA. Evidence defining when treatment should stop is not available, but expert opinion (convened by Novartis, Visudyne manufacturer) suggested stopping “when the situation is judged to be ‘futile’” (Verteporfin Roundtable Participants 2005). FDA labeling states “safety and efficacy of Visudyne beyond 2 years have not been demonstrated.”
Benefit Application
BlueCard/National Account Issues
No applicable information.
Rationale
This policy is based in part on a 2000 TEC Assessment (1) that offered the following observations and conclusions:
- Two multicenter, double-masked, randomized placebo-controlled trials including 402 patients reported that at 1 year of follow-up, fewer patients treated with photodynamic therapy experienced a clinically significant loss of visual acuity compared to those treated with placebo: 38.8% compared to 53.6% ('p< .001).
- Subgroup analysis suggests that the treatment effect is predominantly experienced by patients with age-related macular degeneration characterized by at least 50% classic choroidal neovascularization.
- There were inadequate data to permit scientific conclusions regarding other etiologies of choroidal neovascularization.
The TEC Assessment did not specifically address the issue of frequency of treatment or treatment extending beyond 1 year.
Since the completion of the TEC Assessment, the 2-year results of the pivotal Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) randomized trial of patients with AMD were published. (2) Beneficial outcomes regarding visual acuity and contrast sensitivity noted after 12 months were sustained through 24 months. At the end of 2 years, 53% of the treatment group, as compared to 38% of the placebo group, lost fewer than 15 letters. The average number of applications of verteporfin treatment in the second year (2.2) was lower than that required during the first year (3, 4). A subgroup analysis was reported, comparing results between those patients with predominantly classic CNV(greater than 50% of lesional area) compared to minimally classic CNV (less than 50%). For patients with minimally classic disease, no statistically significant differences in visual acuity were noted.
The Verteporfin in Photodynamic Therapy (VIP) trial is another randomized study that primarily focused on efficacy of photodynamic therapy in patients with occult but no classic lesions who were presumed to have progressive disease due to visual or anatomic deterioration within the previous 3 months. Of the 339 patients enrolled in the trial, 76% had occult disease; the remainder had early classic CNV with good visual acuity. (3) Similar to other randomized trials, the primary outcome was the proportion of eyes with fewer than 15 letters of visual acuity loss. While there was no significant difference between the treatment and placebo groups at 12 months, by 24 months, a significantly lower percentage of those with occult CNV had lost vision (55% vs. 68%, p= .032). These results contrast with those of the TAP trial, although the patient populations are slightly different. The TAP trial required all patients to have some percentage of classic CNV, while the VIP trial recruited patients with occult disease without any evidence of classic CNV. In addition, the VIP trial required patients with occult disease to have experienced recent deterioration in vision. Results for the subgroup of patients with classic CNV but good visual acuity were not reported separately.
Photodynamic therapy has also been investigated in patients with CNV related to pathologic myopia and presumed ocular histoplasmosis. A second arm of the VIP trial focused on 120 patients with pathologic myopia and CNV, either classic, occult, or mixed (although 90% of patients had classic CNV) who were randomized to receive photodynamic therapy or placebo. At month 12, photodynamic therapy stabilized or improved vision (as defined by a loss of fewer than 8 letters on a standard eye chart) in 72% of patients versus 44% on placebo. (4) The authors concluded that verteporfin therapy increases the chance of stabilizing or improving vision compared to placebo treatment for at least 1 year. Results were not reported separately for those with predominantly classic CNV versus occult CNV.
There are minimal published data regarding the use of photodynamic therapy in patients with CNV related to ocular histoplasmosis. The FDA approval was based on an open-label safety study involving 26 patients with ocular histoplasmosis. Visual acuity improved by an average of more than 1 line on a standard eye chart at 12 months (6.7 letters on a standard eye chart) with 28% of patients experiencing a visual acuity improvement of 3 lines (15 letters) or more. Visual acuity decreased by less than 3 lines of vision in 88% of patients during the same time period.
Updates
A 2004 review of the peer-reviewed literature based on MEDLINE identified 3 additional reports from the TAP trial. (5-7) These reports demonstrated positive outcomes with the use of photodynamic therapy for subfoveal choroidal neovascularization and further supported the findings of the earlier TAP trial reports. A Cochrane review was published during this time period that concluded that photodynamic therapy is effective in preventing visual loss in classic and occult CNV due to age-related macular degeneration. (8)
Ergun and colleagues reported on a case series of photodynamic therapy for CNV secondary to central serous chorioretinopathy on 26 eyes in 24 patients. (9) Results demonstrated a mean increase in 2.2 lines of visual improvement at 2 years and no adverse outcomes. While promising, larger and comparative studies are warranted for photodynamic therapy for this indication. Therefore, photodynamic therapy for CNV is no longer considered investigational and photodynamic therapy for CNV secondary to central serous chorioretinopathy is added to the policy statement as investigational.
A 2005 literature review identified 2 articles that support the use of photodynamic therapy for CNV due to age-related macular degeneration. The Visudyne in Minimally Classic Choroidal Neovascularization (VIM) Study Group (10) randomized 117 patients to verteporfin or placebo infusion with standard or reduced light fluence rates. The authors concluded after 24 months of follow-up that verteporfin therapy was safe and reduced the risks of disease progression to predominantly classic CNV and visual acuity loss of at least 15 letters. In a meta-analysis of the safety of photodynamic therapy, Azab and colleagues analyzed data from the 24-month TAP A and B and VIP trials totaling 948 patients with age-related macular degeneration. (11) The authors concluded the safety profile of verteporfin therapy was not statistically different from placebo. An October 2005 TEC Special Report on the treatment of age-related macular degeneration also supports the conclusions given here and notes that the pathway leading to choroidal neovascularization is complex. (12)
Photodynamic Therapy (PDT) in Combination Therapies
The October 2005 TEC Special Report notes therapies are available for AMD to potentially modify (angiostatic agents) and palliate (PDT) the disease. Combining these modalities concurrently or sequentially has a biological basis. The 2005 TEC Special Report found that a host of trials are in progress combining an angiostatic agent with PDT. The angiostatic agents being studied in trials include pegaptanib, ranibizumab, anecortave acetate, squalamine, vitalinib, and triamcinolone. For example, in the pegaptanib trial (13), PDT was administered at physician discretion but an analysis was not provided that examined possible synergistic effects.
2006-2008 Updates
Searches of the MEDLINE database for the period of October 2005 through February 2007 and March 2007- April 2008 found no evidence to support a change in the policy statement. A Cochrane review evaluated results from 3 randomized controlled trials (total of 1022 patients) which included the TAP and VIP trials described above. (14) Meta-analysis showed a 24-month risk ratio of losing 6 or more lines of visual acuity of 0.62 compared to the control group. The authors concluded that photodynamic therapy is probably effective in treating choroidal neovascularization due to AMD, though there is doubt about the size of the effect. Kaiser reported results of a 3-year open-label extension of the TAP study. (15) Out of 402 verteporfin-treated patients who completed the 24-month randomized study, 320 (80%) enrolled in the extension protocol. Patients who chose not to participate in the TAP extension were more likely to be older, have a poorer level of visual acuity, and have evidence of fluorescein leakage, or evidence of progression, at the 24-month examination. Of the 320 enrolled, 193 (60%) completed the 60-month examination and 122 (38%) discontinued prematurely, 3 (1%) were noncompliant. Yearly treatment rates declined from 3.5 treatments in the first year to 0.1 in the fifth year; subjects who remained in the study lost an additional 2.3 lines of letters over the 3-year extension.
Ranibizumab was compared with photodynamic therapy in a multicenter, double-blind study (423 patients) by the ANCHOR study group. (16) Following 12 monthly treatments, patient groups treated with ranibizumab (0.3 or 0.5 mg) and sham verteporfin had 94% to 96% of subjects lose fewer than 15 letters. The patient group treated with monthly sham injection and active verteporfin therapy (average 2.8 times over the year) had 64% of subjects lose fewer than 15 letters. Visual acuity improved by more than 15 letters in 36% and 40% of the ranibizumab groups (average dose-dependent gain of 8.5 and 11.3 letters), in comparison with 5.6% of subjects in the verteporfin group (average loss of 9.5 letters). Intraocular inflammation occurred in 10.2% and 15% of ranibizumab-treated patients, with presumed endophthalmitis in 1.4% and serious uveitis in 0.7% of patients treated with the highest dose.
It appears, based on numerous case reports and case series, that photodynamic therapy is being used in an attempt to decrease choroidal neovascularization of many different etiologies. For example, photodynamic therapy has been reported to slow down, but not prevent or reverse, the progression of disease of choroidal neovascularization associated with angioid streaks ('n=15) and inflammatory chorioretinal disease ('n=5). (17, 18) Controlled studies are lacking, and photodynamic therapy is considered investigational for ophthalmologic disorders other than age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.
Combination Therapies
The FOCUS study group reported first and second year results of a blinded phase I/II multicenter, randomized controlled trial of ranibuzumab (0.5 mg) combined with photodynamic therapy. (19, 20) Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized in a 2:1 ratio to ranibizumab ('n=106) or sham ('n=56) injection (initially 7 days) following verteporfin photodynamic therapy. PDT was repeated only if fluorescein angiography revealed persistent or recurrent leakage from CNV at evaluation visits (3-month intervals). A higher than expected rate of serious intraocular inflammation occurred in the first patients, and the two treatments were subsequently scheduled no closer than 21 days apart. Intent-to-treat analysis showed an average improvement in acuity of 5 letters at both 12 and 24-months (85% retention) with ranizumab, compared with a decrease of 8 letters in the PDT-alone group. Twenty-nine percent of patients in the ranizumab group received additional PDT treatment (average of 0.4 treatments), compared with 93% of patients in the PDT-alone group (average of 3 treatments). Visual acuity improved by 15 or more letters in 25% of patients treated with ranizumab (plus PDT as needed) compared with 7% of the patients treated with PDT alone. Endophthalmitis or intraocular inflammation was observed in 16 (15%) patients treated with ranizumab. The majority of adverse events (9%) reported for the PDT-alone group were AMD-related (i.e., choroidal neovascularization, macular degeneration, retinal hemorrhage).
An open-label assessor-blinded trial ('n=165) from Croatia with short-term (3 month) follow-up reported similar results with bevacizumab and PDT. (21) The frequency of treatment was described only as “standard procedures.” Twenty-two of 52 (42%) patients improved by > 0.2 (logarithm of the minimum angle of resolution) following combined treatment, compared with one (2%) patient treated with bevacizumab alone and none treated with PDT alone. Adverse events (21%) in the bevacizumab groups (alone or combined) were frequent, and included 3 pigment epithelial tears, 12 posterior vitreous detachments, and 7 cataract progressions.< BR> The combined use of corticosteroids and PDT is not supported by recent trial results. (22, 23)
Preferred Practice Patterns (practice guidelines) on photodynamic therapy from the American Academy of Ophthalmology (AAO) are based on the TAP and VIP reports described above. (24) The AAO recommends PDT with verteporfin for subfoveal CNV where the classic component is greater than 50% of the lesion and the entire lesion is 5400 microns or less in diameter. Occult subfoveal CNV may be considered for PDT under specified conditions (see AAO guidelines). While PDT was recommended for recurrent juxtafoveal CNV, evidence was considered insufficient to guide treatment recommendations for the primary use of PDT for juxtafoveal CNV. Combination therapy with VEGF inhibitors and PDT was not discussed.
Medicare Policy
Since July 2001, ocular photodynamic therapy has been eligible for Medicare coverage in the treatment of patients with predominantly classical subfoveal choroidal neovascularization (i.e., occupies < =50% of the area of the entire lesion) associated with age-related macular degeneration only when used in conjunction with verteporfin. However, there was no national Medicare coverage policy for other indications. On review in January 2004, Medicare found evidence to conclude that ocular photodynamic therapy may be reasonable and necessary for patients with age-related macular degeneration with either occult or minimally classic choroidal neovascular lesions 4 disk areas or less in size with evidence of progression within the 3 months prior to initial treatment. (25) Medicare also reiterated use of ocular photodynamic therapy with verteporfin for indications such as pathologic myopia or presumed histoplasmosis syndrome may be eligible for coverage through individual contractor discretion.
References:
- 2000 TEC Assessment; Tab 18.
- BresslerNM. Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: two-year results of 2 randomized clinical trials. TAP Study Group. Arch Ophthalmol 2001;119(2):198-207.
- Verteporfin in Photodynamic Therapy (VIP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: 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):541-60.
- 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. Ophthalmology 2001; 108(5):841-52.
- BresslerNM, Arnold J, Benchaboune MS et al. Verteporfin therapy of subfoveal choroidal neovascularization in patients with age-related macular degeneration: additional information regarding baseline lesion composition’s impact on vision outcomes – TAP report No. 3. Arch Ophthalmol 2002; 120(11):1443-54.
- 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):536-44.
- Blumenkranz MS, Bressler NM, Bressler SB et al. Verteporfin therapy for subfoveal choroidal neovascularization in age-related macular degeneration: three-year results of an open-label extension of 2 randomized clinical trials – TAP report No. 5. Arch Ophthalmol 2002; 120(10):1307-14.
- Wormald R, Evans J, Smeeth L et al. Photodynamic therapy for neovascular age-related macular degeneration (Cochrane Review). In: The Cochrane Library, Issue 1, 2004. Chichester, UK: John Wiley & Sons, Ltd.
- Ergun E, Tittl M, Stur M. Photodynamic therapy with verteporfin in subfoveal choroidal neovascularization secondary to central serous chorioretinopathy. Arch Ophthalmol 2004;122(1):37-41.
- Azab M, Boyer DS, Bressler NM et al. Verteporfin therapy of subfoveal minimally classic choroidal Neovascularization in age-related macular degeneration: 2-year results of a randomized clinical trial. Arch Ophthalmol 2005; 123(4):448-57.
- Azab M, Benchaboune M, Blinder KJ et al. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: meta-analysis of 2-year safety results in three randomized clinical trials: Treatment of Age-Related Macular Degeneration with Photodynamic Therapy and Verteporfin In Photodynamic Therapy Study Report no. 4. Retina 2004; 24(1):1-12.
- 2005 TEC Assessments; tab 11. TEC Special Report: Current and evolving strategies in the treatment of age-related macular degeneration.
- Gragoudas ES, Adamis AP, Cunningham ET et al. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med 2004; 351(27):2805-16.
- Wormald R, Evans J, Smeeth L et al. Photodynamic therapy for neovascular age-related macular degeneration. Cochrane Database Syst Rev 2007; (3):CD002030.
- Kaiser PK; Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group. Verteporfin therapy of subfoveal choroidal neovascularization in age-related macular degeneration: 5-year results of two randomized clinical trials with anopen-label extension: TAP report no. 8. Graefes Arch Clin Exp Ophthalmol 2006; 244(9):1132-42.
- Brown DM, Kaiser PK, Michels M et al; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 2006; 355(14):1432-44.
- Heimann H, Gelisken F, Wachtlin J et al. Photodynamic therapy with verteporfin for choroidal neovascularization associated with angioid streaks. Graefes Arch Clin Exp Ophthalmol 2005; 243(11):1115-23.
- Lim JI, Flaxel CJ, LaBree L. Photodynamic therapy for choroidal neovascularisation secondary to inflammatory chorioretinal disease. Ann Acad Med Singapore 2006; 35(3):198-202.
- Heier JS, Boyer DS, Ciulla TA et al; FOCUS Study Group. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration: year 1 results of the FOCUS Study. Arch Ophthalmol 2006; 124(11):1532-42.
- Antoszyk AN, Tuomi L, Chung CY et al; FOCUS Study Group. Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results. Am J Ophthalmol 2008; 145(5):862-74.
- Lazic R, Gabric N. Verteporfin therapy and intravitreal bevacizumab combined and alone in choroidal neovascularization due to age-related macular degeneration. Ophthalmology 2007; 114(6):1179-85.
- Neovascular Age-Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy (NAPP) Trial Research Group, Gilson MM, Bressler NM, Jabs DA et al. Periocular triamcinolone and photodynamic therapy for subfoveal choroidal neovascularization in age-related macular degeneration. Ophthalmology 2007; 114(9):1713-21.
- Iriyama A, Obata R, Inoue Y et al. Effect of posterior juxtascleral triamcinolone acetonide on the efficacy and choriocapillaris hypoperfusion of photodynamic therapy. Graefes Arch Clin Exp Ophthalmol 2008; 246(3):339-44.
- American Academy of Ophthalmology. Age-Related Macular Degeneration, Preferred Practice Pattern. San Francisco: American Academy of Ophthalmology, 2006. Available at www.aao.org/ppp.
- http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=101.
|
Codes |
Number |
Description |
| CPT | 67221 | Destruction of localized lesions of choroid (e.g., choroidal neovascularization); photodynamic therapy (includes intravenous infusion) |
| 67225 | ;photodynamic therapy, second eye, at single session (list separately in addition to code for primary eye treatment) | |
| ICD-9 Procedure | ||
| ICD-9 Diagnosis | 115.92 | Ocular histoplasmosis |
| 360.21 | Malignant myopia | |
| 362.50-362.52 | Senile macular degeneration code series | |
| HCPCS | J2503 | Injection, pegaptanib sodium, 0.3 mg |
| J2778 | Injection, ranibizumab, 0.1 mg (new code 1/1/08) | |
| J3396 | Injection, verteporfin, 0.1 mg | |
| Type of Service | Vision | |
| Place of Service | Physician’s Office | |
Index
Age-Related Macular Degeneration; Treatment
Macugen
Pegaptanib
Photodynamic Therapy; Age-Related Macular Degeneration
Ranibizumab
Visudyne Therapy
Policy History
| Date | Action | Reason |
| 12/15/00 | Add to Other section | New policy |
| 11/20/01 | Replace policy | Revised: added new indications in policy statement |
| 4/29/03 | Replace policy | Policy revised; no change in policy statement, references added |
| 04/16/04 | Replace Policy | Literature review for the period of 2001 through January 2004 and Medicare policy update; policy statement changed to removeoccult subfoveal choroidal neovascularization from investigational status;choroidal neovascularizationsecondary to central serous chorioretinopathy added to investigational status |
| 06/27/05 | Replace policy | Literature review update for the period of 2004 through May 2005; reference numbers 10 and 11 added. Policy statement unchanged |
| 12/14/05 | Replace policy | Policy updated with October 2005 TEC Special Report; information on combination therapies with PDT added. Literature review for presumed ocular histoplasmosis, pathologic myopia and central serous chorioretinopathy for the period of May 2005 through November 2005. Policy statement unchanged |
| 04/17/07 | Replace policy | Policy updated with literature review; references 15-19 added; policy statement unchanged. Code table updated. |
| 06/12/08 | Replace policy | Policy updated with literature review; references reordered; references 14 and 20-24 added; policy statements unchanged |
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