Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Surgical Correction of Strabismus

Policy #:11.05.07d

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.

MEDICALLY NECESSARY

Surgical correction of strabismus due to any etiology is considered medically necessary and, therefore, covered to attain or restore normal binocular vision in visually immature children who are 10 years of age or younger.

Surgical correction of strabismus for individuals older than 10 years of age is considered medically necessary and, therefore, covered when any of the following criteria are met:
  • Diplopia exists secondary to impaired extraocular muscle coordination.
  • Abnormal head posture is exhibited in an effort to have better clarity of vision.
  • Visual confusion is present (i.e., two separate images are superimposed).
  • Ocular malalignment impairs depth perception or 3-dimensional vision.
  • Other therapies, if indicated, have been ineffective or not tolerated (i.e., the use of prism glasses or eye occlusion [patching] trials).
  • Peripheral vision is impaired due to esotropia (eye deviation inwardly toward the nose).
  • Psychosocial function or vocational status would improve with ocular alignment.

NOT MEDICALLY NECESSARY

Surgical correction of strabismus is considered not medically necessary when the criteria listed above are not met and for all other indications.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, surgical correction of strabismus is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The surgical correction of strabismus is not regulated by the FDA.

Description

The general term "strabismus" describes an ocular alignment abnormality that can occur in one or both eyes, resulting in an eye deviation or "turn" in any direction. Strabismus can be congenital or acquired, latent or manifest, constant or intermittent, and fixed or variable, depending on the position of the gaze. With all of these possibilities, the degree of disability it creates varies widely. The terms used to describe types of strabismus depend on the direction of the eye deviation, the underlying conditions that facilitate its presence, and whether the condition changes with the position of the eye's gaze. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) estimates that 4% of the US population is afflicted with strabismus.

Most strabismus results from an abnormality of the neuromuscular system, including the brain and some cranial nerves, which hinder the ability to control eye movement. It can also be a result of difficulties with one or more of the eye muscles that control ocular movement. Strabismus is commonly described by the direction of the eye misalignment: inward (esotropia), outward (exotropia), upward (hypertropia), downward (hypotropia), or torsional (cyclotropia). Additionally, strabismus is described by its etiology; there are three cranial nerves that control eye movement (III [3], IV[4],VI [6]), and a weakness or palsy in any one or combination of these can result in strabismus. Moreover, strabismus can be congenital or acquired, with some acquired as a result of a vision or life-threatening condition, such as retinoblastoma, head trauma, cranial nerve palsies, orbital fractures, myasthenia gravis, Graves' disease, and Guillain-Barre syndrome. A cerebral vascular accident (CVA) or "stroke" is the leading cause of adult-acquired strabismus, while trauma that affects the brain and its control of eye movement, damage to the cranial nerves that control eye movement, or damage to the eye socket either directly or secondarily can lead to strabismus.

Strabismus can occur in children who exhibit a typical pattern of neurological development with expected, on-time developmental milestones, but it is more likely to develop in children with a concurrent abnormality that affects the brain, such as cerebral palsy, hydrocephalus, Down syndrome, or a brain tumor. Young children who are afflicted with strabismus often develop amblyopia (lazy eye). Since the strabismic child with amblyopia is at increased risk of blindness due to loss of vision in the non-amblyopic eye, it is critical that strabismus be identified early and corrective treatment started immediately.

The alignment problems associated with strabismus are classified in different ways:
  • Onset: Congenital or acquired.
  • Directional: Horizontal, vertical, or cyclotorsional.
  • Accommodation: Accommodative strabismus is able to be fully corrected with glasses. Partially accommodative strabismus is able to be partially corrected with glasses. Finally, non-accommodative strabismus is not able to be corrected with glasses.
  • Frequency: Constant or intermittent, depending on whether the deviation is the same in all positions of gaze (constant) or the deviation varies depending on the direction of gaze (intermittent).
  • Laterality: Unilateral or alternating. Individuals will experience strabismus in the right eye, left eye, or alternating both eyes, but never in both eyes simultaneously.
  • Size: Small, moderate, or large.
  • Primary, secondary, or consecutive: Most strabismus is primary, while secondary strabismus is the result of vision loss or impaired vision. Consecutive strabismus results from an overcorrection (i.e. exotropia resulting from a correction of esotropia).
  • Concomitant (non-paralytic) or incomitant (paralytic): With concomitant strabismus, the magnitude of the deviation does not vary with gaze direction, while the gaze direction does affect the size or presence of the deviation with incomitant strabismus.

Strabismus can be seen at any age. Binocularity of vision is usually well developed by 5 years of age, and visual maturity is reached between 8 and 10 years of age; thus, it is important to address strabismus during this period of time so that vision develops properly in both eyes. Before visual maturity is reached, individuals with strabismus focus preferentially with their non-deviating eye and the brain blocks signals from the deviating eye. This may become permanent if not addressed before visual maturity. In individuals with strabismus, sometimes visual correction is first approached medically by the use of prism glasses; if indicated, such glasses may help to relieve diplopia and visual confusion while helping to restore normal depth perception. But, if the size of the deviation is large, prism glasses will distort the vision and, additionally, do not help the wearer with deviation that occurs depending on the position of gaze (incomitant). However, if any benefit is noted, it can occur only when the user is wearing the glasses; thus, it is a way to compensate for visual problems, not repair them. It is noted, however, that most adult strabismus is incomitant, and therefore, not typically correctable by the use of prism glasses. The use of an eye patch, if indicated, is only a temporizing measure until the condition resolves or, if unresolved, prompts a surgical approach. Sometimes, the use of botulinum toxin agents injected into the rectus muscle may help alleviate the hard muscular pull of one side of the rectus muscle, which is moving the eye out of correct alignment. In addition, visual training exercises (orthoptics/pleoptics) and the use of miotic drops to the eye to manipulate accommodation have been noted to have limited utility.

If the desired result is not obtained or cannot be sustained medically, there are a variety of procedures that can help align the eyes and permit a more optimal visual fusion. Surgical correction of strabismus is variable and depends on the root cause of the problem. Some of the more frequently used surgical corrections are strengthening, weakening, or transpositioning procedures. The most common weakening procedure is recession, in which an outside (extraocular) muscle is detached from the eye and reattached further back on the globe (away from the iris). Weakening procedures can be performed on the afflicted muscle if it is too strong or can be performed on the opposing muscle (antagonist) if the afflicted muscle is too weak. The most common strengthening procedure is resection, typically performed on esotropic eyes, in which a portion of the lateral rectus muscle (ear-side muscle) is removed and then reattached to its original location. Transposition procedures are typically performed on cyclotropic eyes, in which the insertion of the muscle is moved to an entirely new position on the globe. Any combination of these procedures can be employed to obtain ocular alignment. A more recent technique involves the use of adjustable sutures. After surgery, the eye is patched and 4-24 hours later, the eye is evaluated. The suture can be used to weaken or strengthen the muscle and then can be permanently tied into place. This results in better alignment, but is difficult to perform on young children due to the uncomfortable nature of the adjustment. The exact approach for correction is individualized and contingent on the eye's orientation, the degree of ocular muscle dysfunction, and visual field disturbances.

Surgical correction of strabismus in physically symptomatic, visually mature individuals can also result in improved appearance. Psychosocial function and vocational issues are a large part of the body of literature available on adult strabismus surgery. In a joint position statement, the AAPOS and The American Academy of Ophthalmology (AAO) discuss that successful strabismus surgery can relieve diplopia and visual confusion, expand the visual fields, eliminate an abnormal head posture, and restore or establish depth perception, all of which improve and enhance the quality of life and strengthen functionality in daily living.

The term "strabismus" refers to a wide range of malalignments, from horizontal to vertical, to various subcategories of malalignment based on causation. For complete information and more detailed discussion of the various types of strabismus and a range of etiologies, please refer to the AOA's Optometric Clinical Practice Guidelines; Care of the Patient with Strabismus: Esotropia and Exotropia, available at: http://www.aoa.org/optometrists/tools-and-resources/clinical-practice-guidelines.

PEER-REVIEWED LITERATURE

With a lack of strong evidence for any treatment of strabismus, as most studies on the subject involve a small number of subjects, Clarke et al. (2015) designed and executed a pilot study to test the feasibility of conducting a full-scale randomized clinical trial. Surgical correction for strabismus has long been accepted as a standard treatment option, but with high rates of reoperation and an unknown amount of spontaneously resolving strabismus, the authors sought to assess the true rate of successful strabismus surgery when compared to active monitoring. Because of the historical acceptance of surgical correction of strabismus, the authors feared that subjects, parents, and physicians might be hesitant to participate in the “active monitoring” arm of the trial, for fear that vision would irreparably deteriorate during this period. Conversely, subjects, parents, and physicians might think that the subject’s case was not severe enough to warrant surgery and refuse to participate in the surgical arm. Of the 138 eligible subjects, 89 (64.5%) refused to participate. While the authors acknowledge the significant rate of participation refusal, the need for a full-scale trial was confirmed. The pilot study found that active monitoring resulted in neither a decline nor an improvement in visual acuity while strabismus surgery typically resulted in a decrease in visual acuity, with a large rate of overcorrecting, though it was successful in ocular alignment, at least in the short term. The pilot was not powered to prove any of the findings to a statistically-significant level, which is why a large, multi-center RCT is needed on this matter.

In a retrospective cross-sectional study conducted by Leffler et al. (2016), pediatric reoperation and abnormal binocularity rates were compared for 11,115 children who underwent fixed-suture surgery (n=10,806), adjustable-suture surgery (n=260), or botulinum injection (n=49) for the treatment of strabismus between 2007 and 2013. Younger age (<8 years), esotropia, hyperopia, and botulinum injection were found to be associated with postoperative abnormal binocularity. Younger age (<5 years), botulinum injection, vertical and superior oblique surgeries (compared to horizontal surgery), and 3- or 4-muscle surgery were all associated with increased risk of reoperation. The data for this study were collected from an insurance claim database, and are therefore lacking in crucial information, especially with regard to surgical success. Advantages to this study include the large sample size, and the inclusion of data across multiple insurance providers.

In a retrospective cohort study conducted by Chang et al. (2015), the quality of life for adults with strabismus (n=41) was compared to the quality of life for adults with other ocular diseases which included diabetic retinopathy (n=123), age-related macular degeneration (n=108), glaucoma (n=77), cataract (n=93), cytomegalovirus (n=37), and low vision (n=90). Quality of life was evaluated using the standardized and validated 25-item National Eye Institute Visual Functioning Questionnaire. Subjects with strabismus scored worse than any other group in the “ocular pain” subscale and scored the same or worse in almost any other sub-category, which included general health, general vision, near activities, distance activities, vision specific social functioning, vision specific mental health, vision specific role difficulties, vision specific dependency, driving, color vision, and peripheral vision. This study highlights the effect strabismus has on functional quality of life compared to the effect incurred by other ocular diseases which are widely accepted as detrimental to subject well-being.
References


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American Academy of Ophthalmology Pediatric Ophthalmology/Strabismus Panel. Preferred Practice Pattern® Guidelines. Amblyopia. San Francisco, CA: American Academy of Ophthalmology; 2017. Also available on the AAO Web site at: https://www.aao.org/preferred-practice-pattern/amblyopia-ppp-2017. Accessed January 3, 2018.

American Academy of Ophthalmology Pediatric Ophthalmology/Strabismus Panel. Preferred Practice Pattern® Guidelines. Esotropia and Exotropia. San Francisco, CA: American Academy of Ophthalmology; 2017. Also available on the AAO Web site at: https://www.aao.org/preferred-practice-pattern/esotropia-exotropia-ppp-2017. Accessed January 3, 2018.

American Academy of Ophthalmology (AAO). Joint policy statement: Adult strabismus surgery. [AAO Web site]. 2017. Available at: https://www.aao.org/clinical-statement/adult-strabismus-surgery. Accessed January 3, 2018.

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American Academy of Ophthalmology (AAO). Policy statement: Adult strabismus surgery. [AAO Web site]. 2007. Available at:
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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)

67311, 67312, 67314, 67316, 67318, 67320, 67331, 67332, 67334, 67335, 67340, 67343


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)

See Attachment A of this Medical Policy Bulletin.


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Surgical Correction of Strabismus
Description: ICD - 10 Diagnosis Code Numbers and Narratives




Policy History

Revisions from 11.05.07d
03/28/2018This 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: 09/07/2016
Version Issued Date: 09/07/2016
Version Reissued Date: 03/28/2018

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