Latest Review Date: May 2024

Category: Vision

POLICY:

Destruction of macular drusen with laser therapy is considered not medically necessary.

DESCRIPTION OF SERVICE OR PROCEDURE:

Age-related macular degeneration is a painless, insidious process. In its earliest stages, it is characterized by minimal visual impairment and the presence of drusen (i.e., subretinal accumulations of cellular debris adjacent to the basement membrane of the retinal pigment epithelium).

Drusen are deposits located deep in the sensory retina that are seen characteristically in eyes with age-related macular degeneration. As multiple large drusen are a risk factor for the development of visual loss from age-related macular degeneration, laser strategies to cause drusen to resorb have been devised. Studies that have been performed evaluating this technology, thus far, have been small and short-term.

Small drusen are monitored during routine eye exams to make sure they do not develop into large drusen. Larger 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 called the choriocapillaris. The presence of multiple small and/or larger drusen increases the risk of the development of choroidal neovascularization in eyes with age-related macular degeneration.

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 choroidal neovascularization, ultimately leading to improved preservation of vision. The lasers used are those that are widely used for standard photocoagulation of extrafoveal choroidal neovascularization.

KEY POINTS:

The literature search for this policy was performed through May 2, 2024.

Summary of Evidence

A Cochrane review examined the effectiveness and adverse effects of laser photocoagulation of drusen in age-related macular degeneration. The review included eleven studies that randomized 2159 participants (3580 eyes) and followed them up to 2 years, of which 6 studies (1454 participants) included people with 1 eye randomized to treatment and one to control. Overall, the risk of bias in the included studies was low, particularly for the larger studies and for the primary outcome development of choroidal neovascularization. High quality evidence showed that photocoagulation did not reduce the development of choroidal neovascularization at  two years' follow-up.  Two studies investigated the effect on the development of geographic atrophy and could not show a difference, but estimates were imprecise. The CAPT Trial Research Group (2016) included in this review, indicated that despite the influence of laser therapy on drusen, at five years' follow-up, there were no statistically significant differences between treated and untreated eyes in visual acuity, choroidal neovascularization, geographic atrophy, contrast threshold or critical print size. Among secondary outcomes, moderate quality evidence showed that photocoagulation led to drusen reduction but was not shown to limit loss of 3 or more lines of visual acuity.

Evidence from multiple trials, not discussed in the above noted Cochrane review, indicates that drusen ablation does not prevent visual loss, choroidal neovascularization, or age-related macular degeneration. Further study is needed using well-designed, randomized controlled trials regarding the clinical utility and long-term effects of laser induced drusen reduction. The evidence is insufficient to determine that macular drusen photocoagulation results in positive net health outcomes.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The 2019 American Academy of Ophthalmology (AAO) Preferred Practice Patterns Guidelines on age-related macular degeneration (AMD) indicate that there is insufficient data to demonstrate the clinical efficacy of radiation therapy for treating age-related macular degeneration. Therefore, radiation therapy is not recommended for treating this condition.

National Institute for Health and Care Excellence

A National Institute for Health and Care Excellence (NICE) guidance, issued in 2018, for age-related macular degeneration recommends that thermal laser therapy should not be offered for treating drusen in people with early AMD. According to NICE, the evidence presented demonstrated that laser treatment reduces drusen size; however, there was no evidence of an associated effect on AMD progression or vision and noted that patient-relevant benefits have never been demonstrated.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Age-related macular degeneration (AMD), drusen, photocoagulation, macular drusen, ophthalmic laser for drusen

APPROVED BY GOVERNING BODIES:

Laser photocoagulation for macular drusen is a procedure and, as such, is not subject to regulation by the United States Food and Drug Administration (FDA). However, laser devices used to perform this therapy are regulated by the FDA. They are classified under 2 product codes, HQB (Ophthalmic Photocoagulator) and HQF (Ophthalmic Laser), incorporating more than a hundred approved devices.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

REFERENCES:

1. American Academy of Ophthalmology. Preferred practice pattern Guidelines. Age-related macular degeneration. 2019. www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp.
2. Bylsma GW, Guymer RH. Treatment of age-related macular degeneration. Clin Exp Optom. 2005; 88 (5):322-334.
3. Choroidal Neovascularization Prevention Trial Research Group.  Choroid neovascularization in the Choroidal Neovascular Prevention Trial.  Ophthalmology 1998; 105(8): 1364-72.
4. 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.
5. 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, November 2006; 113(11): 1974-1986.
6. Eng VA, Wood EH, Boddu S, et al. Preventing progression in nonexudative age-related macular degeneration with subthreshold laser therapy: a systematic review. Ophthalmic Surg Lasers Imaging Retina. 2019 Mar 1; 50(3):e61-e70.
7. Figueroa MS, Regueras A, Bertrand J. Laser photocoagulation to treat macular soft drusen in age-related macular degeneration. Retina (Philadelphia, Pa.). 1994; 14(5):391-396.
8. Figueroa MS, Regueras A, Bertrand J, Aparicio MJ, Manrique MG. Laser photocoagulation for macular soft drusen. Updated results. Retina. 1997; 17(5):378-84.
9. Findlay Q, Jobling AI, Vessey KA, et al. Prophylactic laser in age-related macular degeneration: The past, the present and the future. Eye (Lond). 2018; 32(5):972-980.
10. Folk JC, Russell SR. Can laser photocoagulation of eyes with high-risk drusen prevent vision loss from age-related macular degeneration? Ophthalmology. 1999 Jul; 106(7):1241-2. 
11. 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.
12. Frennesson C, Nilsson SE.  Prophylactic laser treatment in early age related maculopathy reduced the incidence of exudative complications. J Ophthalmol 1998; 82(10): 1169-74.
13. 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.e1.-622.e1.
14. 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.
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. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
17. 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.
18. Maguire MG, Sternberg P, Aaberg TM, et al. Choroidal Neovascularization Prevention Trial (CNVPT) Research Group. Laser treatment in fellow eyes with large drusen: updated findings from a pilot randomized clinical trial. Ophthalmology. 2003; 110(5):971-978.
19. Mojana F, Brar M, Cheng L, et al. Long-term SD-OCT/SLO imaging of neuroretina and retinal pigment epithelium after subthreshold infrared laser treatment of drusen. Retina. 2011; 31(2):235-242.
20. National Institute for Health and Care Excellence (NICE). Age-related macular degeneration. NICE guide [NG82]. 2018, Jan 23. www.nice.org.uk/guidance/ng82.
21. 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.
22. 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, February 2006; 141(2): 276-281.
23. Virgili G, Michelessi M, Parodi MB, et al. Laser treatment of drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev. 2015 Oct 23; 10:CD006537.

POLICY HISTORY:

Medical Policy Group, August 2004 (4)

Medical Policy Administration Committee, August 2004

Available for comment August 24-October 7, 2004

Medical Policy Group, August 2006 (1)

Medical Policy Group, August 2008 (1)

Medical Policy Group, August 2010 (1) Key Points updated, Changed policy statement to “not medically necessary” previously investigational.

Medical Policy Administration Committee, July 2010

Medical Policy Group, December 2010; 2011 Code updates

Medical Policy Panel, May 2011

Medical Policy Group, May 2011 (2) Key Points updated

Medical Policy Group, May 31, 2011; Active Policy but no longer scheduled for regular literature reviews and updates.

Medical Policy Group, November 2019 (6): Updates to Description, Key Points, Practice Guidelines, Key Words (macular drusen, ophthalmic laser for drusen) and References.

Medical Policy Group, March 2021 (9): Updates to Description, Key Points, References. No change to policy statement. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, April 2022 (9): Updates to Description, Key Points, References. No change to policy statement. Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, April 2023 (9): Reviewed by consensus. Updates to Key Points, Benefit Application, and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, April 2024 (9): Reviewed by consensus. No new published peer-reviewed literature is available that would alter the coverage statement in this policy. Updates to Key Points, Key Words, Benefit Application and References. No change to the policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.