Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Photocoagulation of Macular Drusen

Policy #:11.05.08d

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Photocoagulation of macular drusen is considered not medically necessary and, therefore, not covered because the available published literature does not support its use in the diagnosis or treatment of illness or injury.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, photocoagulation of macular drusen is not eligible for payment under the medical benefits of the Company’s products because the service is considered not medically necessary and, therefore, not covered.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are several lasers approved by the US Food and Drug Administration (FDA) for ophthalmic use. However, because there is no FDA overview of procedures, photocoagulation of macular drusen is not regulated by the FDA.

Description

Age-related macular degeneration (AMD) is a painless condition that results in blindness. Its earliest stages are marked by minimal visual impairment and by subretinal accumulations of cellular debris called soft drusen. The presence of these pale yellow or pale gray domed elevations results in a thickening of the space between the retinal pigment epithelium (RPE) and its blood supply, the choriocapillaris, which leads to choroidal neovascularization (CNV) in affected eyes. The development of CNV is associated with a greatly increased risk of irreversible vision loss. Studies have focused on whether destruction of drusen will prevent advancement to CNV.

Photocoagulation of macular drusen is a specialized ophthalmic procedure that uses low-energy argon or infrared laser therapy to eliminate drusen in an attempt to prevent CNV. Figueroa et al studied 46 individuals with soft drusen. A group of 30 received argon laser therapy in one eye, with the other eye left untreated as a control. The remaining 16 individuals already had CNV in one eye; therefore, treatment was applied to the other eye. The laser treatments decreased the number of soft drusen, but after three years there was no difference in the development of CNV among the groups.

The Choroidal Neovascular Prevention Trial (CNVPT) was undertaken by Ho et al to study the short-term effects of green argon laser therapy versus observation in 351 eyes. They noted that laser-treated eyes showing 50 percent or more reduction in drusen at one year had improved visual acuity compared to the control group. However, individuals with CNV in one eye who received laser treatment in the other eye were more likely to develop CNV in the treated eye. These individuals were excluded from the trial, and the trial continued with a new name: the Complications of Age-Related Macular Degeneration Prevention Trial (CAPT). This study followed 1,051 individuals with bilateral drusen who received laser therapy in one eye only. Individuals were followed for five years. Results from the study found no significant differences in visual acuity compared to the control group during a four-year follow-up.

A pilot study of infrared laser therapy enrolled 152 individuals with either bilateral drusen or unilateral drusen with CNV in the other eye. The eyes were randomly assigned to receive infrared laser therapy or observation. Reduction of drusen was noted in individuals receiving laser therapy, but the study did not review the progression of CNV. The treatment protocol was revised, and recruitment was halted after 23 months due to concerns over laser-induced CNV and associated worsening of visual acuity.

In 2009, Friberg and colleagues from the Prophylactic treatment of age-related macular degeneration (PTAMD) study group reported 3-year outcomes from 639 participants (1278 eyes). Treatment consisted of the placement of an annular grid of 48 extrafoveal, subthreshold laser applications in 1 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 2216 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. In 2015, an update to this review was published and included two additional studies, totaling 11 studies that randomized 2159 participants (3580 eyes) and followed them up to two years, of which six studies (1454 participants) included people with one eye randomized to treatment and one to control. The authors’ conclusions remained unchanged.

Although the currently available data indicate that photocoagulation of macular drusen results in some short-term vision improvement, the outcome of greatest interest is the reduction of vision loss from CNV, which has not been exhibited in individuals undergoing this type of treatment. In multiple trials, the evidence demonstrates that drusen ablation does not prevent visual loss, CNV, or AMD, and may expose individuals to potential harm due to untoward effects from treatment lasers.
References


American Academy of Ophthalmology Retina/Vitrous Panel. Preferred Practice Pattern® Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Opthalmology; 2015. Available at: https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp-2015. Accessed January 2, 2018.

Arroyo JG. Age-related macular degeneration: Treatment and prevention. 03/31/2017. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed January 2, 2018.

Choroidal Neovascularization Prevention Trial Research Group. Choroid neovascularization in the Choroidal Neovascularization Prevention Trial. Ophthalmology. 1998;105(8):1364-1372.

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.

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.

Figueroa MS, Regueras A, Bertrand J. Laser photocoagulation to treat macular soft drusen in age-related macular degeneration. Retina. 1994;14(5):391-396.

Figueroa MS, Regueras A, Bertrand J, et al. Laser photocoagulation for macular soft drusen. Updated results. Retina. 1997;17(5):378-384.

Folk JC, Russell SR. Can laser photocoagulation of eyes with high-risk drusen prevent vision loss from age-related macular degeneration? Ophthalmology. 1999;106(7):1241-1242.

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.

Frennesson IC. Prophylactic laser treatment in early age-related maculopathy: An 8-year follow-up in a randomized pilot study shows a reduced incidence of exudative complications. Acta Ophthalmol Scand. 2003;81(5):449-454.

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):905-909.

Frennesson IC, Nilsson SE. Prophylactic laser treatment in early age-related maculopathy reduced the incidence of exudative complications. Br J Ophthalmol. 1998;82(10):1169-1174.

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.

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):1367-1374.

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.

Maguire M, Complications of Age-Related Macular Degeneration Prevention Trial Research Group (CAPT). Baseline characteristics, the 25-Item National Eye Institute Visual Functioning Questionnaire, and their associations in the Complications of Age-Related Macular Degeneration Prevention Trial (CAPT).Ophthalmology.2004;111(7):1307-1316.

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):2082-2090.

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):276-281.

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.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. IRIS
Medical® OcuLight® SL/SLx. 510(k) summary. [FDA Web site]. 05/03/02. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf2/k020374.pdf. Accessed January 2, 2018.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. LightLas 810 Infrared Laser Photocoagulator. Premarket approval letter. [FDA Web site]. 08/08/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k021538.pdf. Accessed January 2, 2018.

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;(10):CD006537.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT PHOTOCOAGULATION OF MACULAR DRUSEN
67299


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

H35.361 Drusen (degenerative) of macula, right eye
H35.362 Drusen (degenerative) of macula, left eye
H35.363 Drusen (degenerative) of macula, bilateral
H35.369 Drusen (degenerative) of macula, unspecified eye



HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 11.05.08d

03/28/2018

This policy has undergone a routine review, and no revisions have been made.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 06/14/2017
Version Issued Date: 06/14/2017
Version Reissued Date: 03/28/2018

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