Photocoagulation laser treatment is a technique, which has been proposed to treat soft macular drusen, a condition in which pale whitish-yellow deposits of extracellular material form on the retinal pigment epithelium layer of the retina. Soft drusen accompany the early stages of age-related maculopathy (ARM). The presence of soft macular drusen has been linked to higher rates of progression to age-related macular degeneration (AMD), the advanced stage of ARM. This policy addresses photocoagulation laser treatment of macular drusen. 
 

Investigational/Not Medically Necessary:

Photocoagulation of macular drusen is considered investigational/not medically necessary .

Rationale

Studies have shown laser therapy can induce regression of drusen, not only at the treatment site, but also at sites remote from the laser (Figueroa, 1994; Frennesson, 1995; Figueroa, 1997; Frennesson, 1998). However, the outcome of greatest interest is severe vision loss from atrophy and development of choroidal neovascularization (CNV).

The Choroidal Neovascular Prevention Trial (CNVPT) consisted of a randomized trial of 351 eyes with unilateral or bilateral drusen randomized to receive green argon laser therapy or observation (Ho, 1999).  No statistically significant difference in visual acuity was seen at 4 years of follow-up in 120 patients randomized to either photocoagulation or observation. A subsequent analysis suggested an increased incidence of CNV development in the laser-treated eyes in patients with CNV in the fellow eye (CNVPT Research Group, 1998, 2003). Subsequently these patients were excluded from the trial. The trial continued, renamed the Complications of AMD Prevention Trial (CAPT), and enrolled only those patients with bilateral drusen; one eye was assigned to laser treatment and the other received no treatment (CAPT Group, 2006).

The CAPT was conducted at 22 clinical centers involving 1052 participants who were observed for at least 5 years after laser treatment. Follow-up of patients was excellent; less than 3% of visual acuity examinations were missed. At 5 years, 188 (20.5%) treated eyes and 188 (20.5%) observed eyes had visual acuity scores ≥3 lines worse than at the initial visit (p= 1.00). The cumulative 5-year incidence rates for treated and observed eyes for CNV were 13.3% and 13.3% (p=0.95), respectively; and for geographic atrophy were 7.4% and 7.8% (p=0.64), respectively. The contrast threshold doubled in 23.9% of treated eyes and in 20.5% of observed eyes (p=0.40). The critical print size doubled in 29.6% of treated eyes and in 28.4% of observed eyes (p=0.70). Seven (0.7%) treated eyes and 14 (1.3%) observed eyes had an adverse event of a ≥6 -line loss in visual acuity in the absence of late AMD or cataract. As applied in CAPT, low intensity laser treatment did not demonstrate a clinically significant benefit on vision in eyes of people with bilateral large drusen.

An initial randomized pilot study of infrared laser therapy enrolled 152 patients (229 eyes) with either bilateral drusen or unilateral drusen, where CNV was detected in the fellow eye (Olk, 1999). The eyes were randomized to receive infrared 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 the results of the initial pilot study, the Prophylactic Treatment of AMD trial (PTAMD) was a multicenter, prospective, randomized controlled trial of 244 patients with a neovascular or advanced AMD lesion in one eye and, in the fellow “study” eye, (1) at least 5 drusen, (2) Early Treatment Diabetic Retinopathy Study best-corrected VA (BCVA) of 20/63 or better, and (3) no evidence of neovascularization at baseline (Friberg, 2006). Patients were randomized to infrared laser therapy or observation of their study eye. The rate of CNV events in treated eyes consistently exceeded that in observed eyes. At 1 year, the difference was 15.8% versus 1.4% (P = 0.05) Treated eyes showed a higher rate of VA loss (≥3 lines) at 3- and 6-month follow-ups relative to observed eyes (8.3% vs. 1% and 11.4% vs. 4%, respectively). After 6 months, no significant differences were observed in VA loss between groups. The authors advised against using prophylactic subthreshold diode laser treatment in patients with bilateral drusen.

In a randomized controlled clinical trial by Owens and associates (2006), the Drusen Laser Study (DLS) evaluated laser therapy to prevent CNV and vision loss in high risk age-related maculopathy (ARM) (n=156). Two cohorts of patients, a unilateral group with CNV in the fellow eye and drusen in the study eye and a bilateral group with bilateral drusen, were randomized to laser treated or observed groups. The authors noted earlier onset of choroidal neovascularization in the group treated with laser photocoagulation of macular drusen than the non-treated group. Visual acuity loss also occurred more frequently in the treatment group. Study recruitment was terminated due to the findings.

Randomized controlled clinical trials have failed to show a clinical benefit from prophylactic laser treatment of macular drusen. Study results suggest laser treatment may accelerate the onset of CNV. Therefore, photocoagulation of macular drusen is considered investigational/not medically necessary.

Background/Overview

Description of the Disease

Age related macular degeneration is the leading cause of severe vision loss in people over 55 years of age in the developed world. 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 choriocapillaries.  Clinical and epidemiologic studies have shown that the presence of large and/or numerous soft drusen increase the 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. The emergence of CNV greatly increases the risk of subsequent irreversible loss of vision.

Description of Technology

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 choroidal neovascularization. Therefore, the treatment of macular drusen represents an additional indication for an existing U.S. Food and Drug Administration (FDA) approved laser.

Photocoagulation laser surgery is done on an outpatient basis, requiring no overnight hospital stay. In this treatment, laser light rays are directed into the eye, focusing on abnormal blood vessels that are growing beneath the retina. This laser seals the blood vessels from further leakage in the hope of preventing further vision loss.  Prior to the treatment, eye drops are given to dilate the pupil and numb the eye. The patient remains awake but some may experience mild pain, which can usually be relieved with non-prescription pain medication. The laser treatment usually takes less than thirty minutes to complete, and the patient can go home immediately following surgery. It may be several weeks before surgical success is known, and many patients will need more than one treatment.

Definitions

Age-Related Macular Degeneration (AMD): a disease blurring the sharp, central vision needed for "straight-ahead" activities such as reading, sewing, and driving; AMD affects the macula, the part of the eye used for fine detail; AMD causes no pain; in some cases, AMD advances so slowly that people notice little change in their vision; in others, the disease progresses faster and may lead to a loss of vision in both eyes

Choroidal Neovascularization: abnormal growth of new blood vessels in the choroid

Dry AMD: occurs when light-sensitive cells in the macula slowly break down, gradually blurring central vision in the affected eye; dry AMD generally affects both eyes, but vision can be lost in one eye while the other eye seems unaffected; dry AMD has three stages, all of which may occur in one or both eyes

1. Early AMD: people with early AMD have either several small drusen or a few medium-sized drusen; at this stage, there are no symptoms and no visual loss
2. Intermediate AMD: people with intermediate AMD have either many medium-sized drusen or one or more large drusen; some people see a blurred spot in the center of their vision; more light may be needed for reading and other tasks
3. Advanced Dry AMD: in addition to drusen, people with advanced dry AMD have a breakdown of light-sensitive cells and supporting tissue in the central retinal area; this breakdown can cause a blurred spot in the center of the patient’s vision; over time, the blurred spot may enlarge and darken taking more of central vision; the patient may have difficulty reading or recognizing faces until they are very close to the other person

Wet AMD: occurs when abnormal blood vessels behind the retina start to grow under the macula; these new blood vessels tend to be very fragile and often leak blood and fluid; the blood and fluid raise the macula from its normal place at the back of the eye; damage to the macula occurs rapidly; with wet AMD, loss of central vision can occur quickly; Wet AMD is considered to be advanced AMD and is more severe than the dry form

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

When services are also Investigational/Not Medically Necessary:

CPT

ICD-9 Diagnosis

References

Peer Reviewed Publications:

1. 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):1974-1986.
2. Figueroa MS, Regueras A, Bertrand J et al.   Laser photocoagulation for macular soft drusen.  Updated results.  Retina 1997; 17:378-384. 
3. Figueroa MS, Regueras A, Bertrand J.   Laser photocoagulation to treat macular soft drusen in age-related macular degeneration.  Retina 1994; 14:391-396.  
4. Figueroa M, Schocket LS, Dupont J, et al.  Long-Term Effect of Laser Treatment for Dry Age-Related Macular Degeneration on Choroidal Hemodynamics. Am J Ophthalmol. 2006 Mar 7; [Epub ahead of print].
5. Folk JC, Russell SR.  Can laser photocoagulation of eyes with high-risk drusen prevent vision loss from age-related macular degeneration?  Ophthalmology 1999; 106:1241-1242. 
6. Frennesson C, Nilsson SEG.   Prophylactic laser treatment in early age related maculopathy reduced the incidence of exudative complications.  Br J Ophthalmol 1998; 82:1169-1174. 
7. Frennesson IC, Nilsson SEG.   Effects of argon (green) laser treatment of soft drusen in early age-related maculopathy: A 6-month prospective study.  Br J Ophthalmol 1995; 79:905-909.  
8. Friberg TR, Musch DC, Lim JI, et al.  PTAMD Study Group.   Prophylactic treatment of age-related macular degeneration report number 1: 810-nanometer laser to eyes with drusen. Unilaterally eligible patients. Ophthalmology. 2006 113(4):612-622.
9. 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; 106:1367-1373. 
10. 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; 106:2082-2090. 
11. Owens SL, Bunce C, Brannon AJ, et al.; Drusen Laser Study Group. Prophylactic laser treatment hastens choroidal neovascularization in unilateral age-related maculopathy: final results of the drusen laser study. Am J Ophthalmol. 2006; Feb;141(2):276-281.
12. The Choroidal Neovascularization Prevention Trial Research Group. Choroid neovascularization in the Choroidal Neovascular Prevention Trial.  Ophthalmology 1998; 105:1364-1372. 
13. 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):971-978.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Association. Special Report: Current and Evolving Strategies in the Treatment of Age-Related Macular Degeneration. Tec Assessment, 2005; 20(11).
2. Centers for Medicare and Medicaid Services. National Coverage Determination for Laser Procedures. NCD #140.5.  Effective May 1, 1997. Available at:
   http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=140.5&ncd_version=1 &basket=ncd%3A140%2E5%3A1%3ALaser+Procedures. Accessed on February 5, 2007.
3. Retina Panel, Preferred Practice Patterns Committee. American Academy of Ophthalmology (AAO). Age-related macular degeneration limited revision. September 2006. Available at:  http://www.aao.org/education/library/ppp/upload/ Age_Related_Macular_Degeneration-2.pdf. Accessed on February 5, 2007.
   

Web Sites for Additional Information

1. National Eye Institute.  U.S. National Institutes of Health.  Age-Related Macular Degeneration: What you should know. Modified December 2006. Available at:    http://www.nei.nih.gov/health/maculardegen/armd_facts.asp.  Accessed on February 5, 2007.

Index

Policy History

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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