Subject:
Photocoagulation of Macular Drusen
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Photocoagulation describes the use of focused laser energy to treat disease. Laser photocoagulation of macular drusen has been evaluated as a method of slowing progression to advanced age-related macular degeneration (AMD).
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 or “soft” drusen, i.e., subretinal accumulations of cellular debris adjacent to the basement membrane of the retinal pigment epithelium.
Large drusen appear as large, pale yellow or pale gray domed elevations and result in thickening of the space between the retinal pigment epithelium and its blood supply, the choriocapillaris. Clinical and epidemiologic studies have shown that the presence of large and/or numerous soft drusen is associated with an increased risk of the development of choroidal neovascularization (CNV) in eyes with AMD. For example, in patients with bilateral drusen, the 3-year risk of developing CNV is estimated to be 13%, rising to 18% for those over the age of 65 years. The emergence of CNV greatly increases the risk of subsequent irreversible loss of vision.
Two different kinds of low energy laser therapies, argon and infrared laser, have been investigated as techniques to eliminate drusen by photocoagulation in an effort to prevent the evolution to CNV, ultimately leading to improved preservation of vision. The lasers used are those that are widely used for standard photocoagulation of extrafoveal CNV. Therefore, the treatment of macular drusen represents an additional indication for an existing laser approved by the U.S. Food and Drug Administration (FDA).
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Destruction of macular drusen with laser therapy is not considered medically necessary.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon BCBSNJ Medical Policy.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[RATIONALE: While studies have shown that laser therapy can induce regression of drusen, not only at the treatment site, but also at sites remote from the laser, outcomes of greatest interest are preventing vision loss from atrophy and choroidal neovascularization (CNV). Unfortunately, the biologic rationale has not translated into patient benefit, as demonstrated in multiple trials.
Following initially optimistic results, Figueroa and colleagues updated follow-up in 46 patients with confluent soft drusen. A total of 30 patients with bilateral drusen were randomized to receive argon green laser therapy in 1 eye. The remaining 16 patients had CNV in 1 eye and laser therapy performed on the other eye. Although laser therapy resulted in resolution of the drusen, after 3 years there was no difference between the groups regarding development of CNV.
The Choroidal Neovascular Prevention Trial (CNVPT) randomized eyes with exudative age-related macular degeneration (AMD) in 1 eye and 10 or more large drusen in the other (Fellow Eye Study, 120 patients, 120 study eyes) or bilateral large drusen without exudative AMD (Bilateral Drusen Study, 156 patients, 312 study eyes) to receive argon green laser therapy or observation. Due to an increased incidence of CNV in laser-treated eyes, enrollment and treatment was suspended in December 1996. An earlier report excluding eyes developing CNV found eyes with 50% or more drusen reduction at 1 year had more increases in visual acuity compared to the control group. An updated report from the Fellow Eye Study found no significant differences in visual acuity between photocoagulation or observation eyes during a 4-year follow-up. In addition, the authors noted an increased risk of CNV in treated eyes treated early during follow-up (23% treated eyes vs. 5% observed at 1 year) but diminished over time (33% and 32% at 30 months, respectively). Higher intensity laser treatment was associated with greater risk of developing CNV.
The National Eye Institute-sponsored Complications of AMD Prevention Trial (CAPT) enrolled patients with bilateral large drusen (n=1,052); 1 eye was assigned to low-intensity laser treatment and the other to observation. After 5 years, there were no differences between treated and observed eyes in worsening visual acuity (20.5% in both groups lost >3 ETDRS [Early Treatment of Diabetic Retinopathy Study] lines), development of CNV (13.3% in both groups) or geographic atrophy.
A pilot study of infrared laser therapy (810 nm) enrolled 152 patients (229 eyes) who had either bilateral drusen or unilateral drusen if CNV was detected in the fellow eye. Eyes were randomized to receive laser therapy or observation. While laser therapy was associated with resolution of drusen and improved visual acuity, the study was not powered to detect an effect on progression to CNV. Based on these results, the prophylactic treatment of AMD trial (PTAMD) followed 244 patients with CNV or advanced AMD in 1 eye and >5 drusen and no CNV in the fellow eye. Treatment consisted of an extrafoveal grid of subthreshold 810-nm laser spots. Enrollment was halted after 47 months due to an excess of CNV in treated eyes. CNV occurred more often in treated eyes (15.8% vs. 1.4% at 1 year); there were no differences in moderate (>3 ETDRS lines) visual loss after 6 months, with or without treatment.
The drusen laser study randomized patients with eyes at high risk for AMD. Follow-up was completed over 3 years. A unilateral group (n=177) in the trial included patients with drusen in the study eye and CNV in the fellow eye; the bilateral group (n=105) had drusen in both eyes. The treatment protocol was revised and recruitment ultimately halted after 23 months due to concerns over laser-induced CNV in interim analyses. In the unilateral group, prophylactic laser treatment hastened the onset of CNV (29.7% vs. 17.7% observed, p=0.06) and was associated with worsening visual acuity. In the bilateral group, 3-year CNV incidence was 11.6% in laser-treated eyes versus 6.8% without treatment (p=0.22). In both groups, visual loss paralleled development of CNV.
In 2009, Friberg and colleagues from the PTAMD study group reported 3-year outcomes from 639 participants (1,278 eyes). (12) Treatment consisted of the placement of an annular grid of 48 extrafoveal, subthreshold laser applications in one eye of each participant. Subthreshold laser treatment did not decrease the incidence of CNV in comparison with the other (fellow) eye. A very slight benefit in visual acuity (1.5 letter difference) was found at 24 months, but this effect was not sustained at 3 years. The authors concluded that a single subthreshold 810-nanometer laser treatment to eyes of participants with drusen is not an effective prophylactic strategy against CNV.
A Cochrane review on laser treatment of drusen to prevent progression to advanced AMD was published in 2009. Nine randomized studies with a total of 2,216 patients were included in the systematic review. Two of the studies reported significant drusen disappearance at 2 years, but photocoagulation did not appear to affect the development of CNV at 2 years’ follow-up. The authors concluded that the trials confirmed the clinical observation that laser photocoagulation of drusen leads to their disappearance. However, there is no evidence that this reduces the risk of developing CNV, geographic atrophy, or visual acuity loss.
UpToDate has this to say: [W]ith the availability of newer pharmacologic therapies and the risk of scotoma and vision loss with photocoagulation, laser photocoagulation for choroidal neovascularization is rarely recommended. Thermal laser photocoagulation uses a relatively high intensity of thermal laser energy to coagulate the abnormal choroidal neovascular membrane. An adverse consequence of this treatment is focal damage to the overlying retina with the formation of a permanent blind spot. Thus, if used, this treatment should be limited to very small lesions outside of the central macula.
Summary
Evidence from multiple trials indicates that drusen ablation does not prevent visual loss, CNV, or AMD. Furthermore, the evidence from trials indicates that drusen ablation may be accompanied by complications. The literature indicates that photocoagulation of macular drusen procedure is not clinically appropriate; this approach is not considered medically necessary.
Technology Assessments, Guidelines and Position Statements
Preferred Practice Patterns (practice guidelines) on photodynamic therapy from the American Academy of Ophthalmology (AAO) recommend regular dilated eye exams for the early detection of the intermediate stage of AMD and possible treatment with antioxidants and minerals for patients who have progressed to intermediate or advanced AMD in 1 eye. No recommendations were made regarding photocoagulation of macular drusen. The guidelines state that “patients with intermediate AMD who are at increased risk of visual loss or of progression to advanced AMD should be educated about methods of detecting new symptoms of CNV and about the need for prompt notification to an ophthalmologist who can confirm if the new symptoms are from CNV and who can begin treatment if indicated.”]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Photocoagulation of Macular Drusen
Drusen, Laser Therapy
Laser Therapy, Macular Drusen
Macular Drusen Destruction
References:
1. Figueroa MS, Regueras A, Bertrand J. Laser photocoagulation to treat macular soft drusen in age-related macular degeneration. Retina 1994; 14(5):391-6.
2. Frennesson IC, Nilsson SE. Effects of argon (green) laser treatment of soft drusen in early age-related maculopathy: a 6 month prospective study. Br J Ophthalmol 1995; 79(10):905-9.
3. Frennesson C, Nilsson SE. Prophylactic laser treatment in early age related maculopathy reduced the incidence of exudative complications. Br J Ophthalmol 1998; 82(10):1169-74.
4. Figueroa MS, Regueras A, Bertrand J et al. Laser photocoagulation for macular soft drusen. Updated results. Retina 1997; 17(5):378-84.
5. Ho AC, Maguire MG, Yoken J et al. Laser-induced drusen reduction improves visual function at 1 year. Choroidal Neovascularization Prevention Trial Research Group. Ophthalmology 1999; 106(7):1367-73.
6. The Choroidal Neovascularization Prevention Trial Research Group. Choroid neovascularization in the Choroidal Neovascular Prevention Trial. Ophthalmology 1998; 105(8):1364-72.
7. The Choroidal Neovascularization Prevention Trial Research Group. Laser treatment in fellow eyes with large drusen: updated findings from a pilot randomized clinical trial. Ophthalmology 2003; 110(5):971-8.
8. Complications of Age-Related Macular Degeneration Prevention Trial Research Group. Laser treatment in patients with bilateral large drusen: the complications of age-related macular degeneration prevention trial. Ophthalmology 2006; 113(11):1974-86.
9. Olk RJ, Friberg TR, Stickney KL et al. Therapeutic benefits of infrared (810-nm) diode laser macular grid photocoagulation in prophylactic treatment of nonexudative age-related macular degeneration: two-year results of a randomized pilot study. Ophthalmology 1999; 106(11):2082-90.
10. Friberg TR, Musch DC, Lim JI et al. Prophylactic treatment of age-related macular degeneration report number 1: 810-nanometer laser to eyes with drusen. Unilaterally eligible patients. Ophthalmology 2006; 113(4):622.e1.
11. Owens SL, Bunce C, Brannon AJ et al. Prophylactic laser treatment hastens choroidal neovascularization in unilateral age-related maculopathy: final results of the drusen laser study. Am J Ophthalmol 2006; 141(2):276-81.
12. Friberg TR, Brennen PM, Freeman WR et al; PTAMD Study Group. Prophylactic treatment of age-related macular degeneration report number 2: 810-nanometer laser to eyes with drusen: bilaterally eligible patients. Ophthalmic Surg Lasers Imaging 2009; 40(6):530-8.
13. Parodi MB, Virgili G, Evans JR. Laser treatment of drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev 2009; (3):CD006537.
14. American Academy of Ophthalmology. Age-Related Macular Degeneration, Preferred Practice Pattern. San Francisco: American Academy of Ophthalmology, 2006. Available online at: www.aao.org/ppp. Last accessed May 2011.
15. Huang YX, Xiang LN, Wang YL, et al. Long-term effect of prophylactic laser treatment for bilateral soft drusen. Chin Med J (Engl) 2011;124(4):541-545.
16. Lenassi E, Troeger E, Wilke R, et al. Laser clearance of drusen deposit in patients with autosomal dominant drusen (p.Arg345Trp in EFEMP1). Am J Ophthalmol 2013;155(1):190-198.
17. Virgili G, Michelessi M, Parodi MB, et al. Laset treatment of Drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev 2015 Oct 23;(1):CD006537.
18. Chehade L, Chidlow G, Wood J, et al. Review of Short-Duration Retinal Lasers. Clin Experiment Ophthalmol 2016 Apr 5 [Epub ahead of print]
19. UpToDate. Age-related macular degeneration: Treatment and prevention. Literature review current through June 2016. Topic last updated March 2, 2016.
20. Arroyo JG. Age-related macular degeneration: Treatment and prevention. In: UpToDate, Trobe J, Schmader KE, Libman H (Eds), UpToDate, Waltham, MA. (Accessed on July 5, 2017.)
21. Arroyo JG. Age-related macular degeneration: Treatment and prevention. In: UpToDate, Trobe J, Schmader KE, Sullivan DJ (Eds), UpToDate, Waltham, MA. (Accessed on May 29, 2018.)
22. Arroyo JG. Age-related macular degeneration: Treatment and prevention. In: UpToDate, Trobe J, Schmader KE, Givens J (Eds), UpToDate, Waltham, MA. (Accessed on June 7, 2019.)
23. Arroyo JG. Age-related macular degeneration: Treatment and prevention. In: UpToDate, Gardiner MF, Schmader KE, Givens J (Eds), UpToDate, Waltham, MA. (Accessed on June 8, 2020.)
Codes:
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CPT*
HCPCS
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