Medical Coverage Policy: 0125

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients.

Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies.

In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.

Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment where appropriate and have discretion in making individual coverage determinations.

Where coverage for care or services does not depend on specific circumstances, reimbursement will only be provided if a requested service(s) is submitted in accordance with the relevant criteria outlined in the applicable Coverage Policy, including covered diagnosis and/or procedure code(s). Reimbursement is not allowed for services when billed for conditions or diagnoses that are not covered under this Coverage Policy (see "Coding Information" below).

When billing, providers must use the most appropriate codes as of the effective date of the submission. Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered.

Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Coverage Policy

Coverage for the surgical treatment of a refractive error varies across plans. Refer to the customer’s benefit plan document for coverage details.

Standard monofocal intraocular lens (IOL) implant is considered medically necessary for ANY of the following conditions:

• anisometropia of 2 diopters or greater, and uncorrectable vision with the use of glasses or contact lenses
• following cataract extraction
• trauma to the eye which has damaged the lens
• congenital cataract
• congenital aphakia
• lens subluxation/displacement

Standard monofocal intraocular lens (IOL) implant for any indication not listed above is not covered or reimbursable.

Premium intraocular lens implants are intended to reduce the need for reading glasses and thus considered a convenience item.

The following lenses are excluded in many benefit plans and/or not covered or reimbursable for any indication:

• presbyopia correcting IOL
• astigmatism correcting IOL
• phakic IOL

REPLACEMENT

Replacement of a medically necessary intraocular lens implant when anatomical change, inflammatory response or mechanical failure renders a previously implanted intraocular lens ineffective or nonfunctional is considered medically necessary.

General Background

The most common indication for an intraocular lens implant is cataract surgery. Cataracts – hardening or opacification (clouding) of the normally transparent crystalline lens within the eye – usually occur as part of the aging process but may be congenital, traumatic or related to other systemic diseases or medications. The current cataract procedure of choice is an extracapsular technique (removal of only the lens) with implantation of a posterior chamber (behind the iris) intraocular lens within the capsular bag. An intraocular lens (IOL) is a tiny, artificial lens for the eye. It replaces the eye's natural lens that is removed during cataract surgery. Most IOLs are made of silicone or acrylic. They may also be coated with a special material to help protect the eyes from harmful ultraviolet rays. Replacement of the lens restores optical focusing power lost by removal of the natural crystalline lens.

The choice of IOL is dependent on physician recommendation and the visual needs of each individual. Monofocal IOLs meet the basic functional needs of an individual who undergoes cataract removal.

Other related vision disorders include:

• refractive error – any of a number of size- and shape-related abnormalities of the eyeball or other components of the eye that affect the normal ability of the eye to focus light on the retina.
• astigmatism – a refractive error caused by an uneven curve in the cornea or lens, so light (an image) fails to come to a single focus on the retina to produce clear vision. Instead, multiple focus points occur, either in front of the retina or behind it or both.
• nearsightedness (i.e., myopia) – a refractive error that occurs when the eyeball is too long, relative to the focusing power of the cornea and lens of the eye. This causes light rays to focus at a point in front of the retina, rather than directly on its surface. A nearsighted person typically will have difficulty reading road signs and seeing distant objects clearly. Myopia is the most common refractive error of the eye. It has become much more prevalent in recent years, purportedly due to eye fatigue from computer use and other extended near vision tasks and possibly genetic predisposition for myopia. Nearsightedness also can be caused by the cornea and/or lens being too curved for the length of the eyeball. In some cases, myopia is due to a combination of these factors.
• farsightedness (i.e., hyperopia) – a refractive error that occurs when light rays entering the eye focus behind the retina, rather than directly on it. A person can see distant objects very well but has difficulty focusing on objects that are up close. The eyeball of a farsighted person is shorter than normal. Many children are born farsighted, and some of them outgrow it as the eyeball lengthens with normal growth.
• presbyopia – a refractive error that frequently begins at around age 40, when people start having trouble reading small print. It is believed to stem from a gradual thickening and loss of flexibility of the natural lens inside your eye. This differs from astigmatism, nearsightedness and farsightedness, which are related to the shape of the eyeball and are caused by genetic and environmental factors.

aphakia – the absence of the natural lens which may result from extraction of the lens (e.g., cataract surgery), penetrating trauma, or from congenital conditions.

anisometropia – refers to the condition in which one eye has a different refractive error than the other. Usually, the eye with the least amount of refractive error is the dominant or preferred eye while the other eye may be suppressed and develop amblyopia (lazy eye). Greater degrees of anisometropia or astigmatism result in increased risk and severity of amblyopia.

Types of Intraocular lens (IOLs)

IOLs other than monofocal, referred to as premium or deluxe lenses, are often recommended to individuals undergoing cataract surgery. Premium lenses are intended to reduce the need for vision correction following cataract surgery; however, they are considered not medically necessary.

Monofocal:

The most common type of lens used with cataract surgery is a monofocal IOL set to focus for up-close, medium range or distance vision. Most people have them set for clear distance vision. Conventional monofocal lenses are spherical, meaning they are designed to provide clear vision at a single focal point (usually far away for good driving vision, for example). With conventional IOLs, typically eyeglasses or contact lenses are also needed in order to use a computer, read or perform other close-up tasks within arm's length.

Multifocal:

IOLs that provide both distance and near focus at the same time are called multifocal IOLs. The lens has different zones set at different powers. It is designed so that the brain learns to select the right focus automatically. Multifocal IOLs contain added magnification in different parts of the lens to help treat presbyopia, decreasing the need for reading glasses or computer glasses after cataract surgery. Multifocal IOLs tend to provide better near vision than accommodating IOLs, but they also are more likely to cause glare or mildly blurred distance vision.

Examples of FDA-approved multifocal IOLs include AcrySof IQ PanOptix Trifocal IOL (Alcon), Tecnis Multifocal IOL (Abbott Medical Optics), and AcrySof IQ ReSTOR (Alcon).

Accommodative:

These lens move or change shape inside your eye, allowing focusing at different distances. Accommodative IOLs expand the range of clear vision with both an aspheric design (as opposed to spherical design of monofocal IOLs) and also flexible "haptics" — the supporting legs that hold the IOL in place inside the eye. These flexible legs allow the accommodating IOL to move forward slightly when looking at near objects, which increases the focusing power of the eye enough to provide better near vision than a conventional monofocal lens.

FDA-approved accommodating IOLs include Crystalens AO and Trulign Toric IOL, both made by Bausch + Lomb. (The Trulign Toric lens corrects astigmatism as well as presbyopia.)

Toric:

A toric lens is custom made to correct astigmatism as well as nearsightedness or farsightedness. Astigmatism is a refractive error caused by an uneven curve in the cornea or lens. The toric lens is designed with different powers in different meridians of the lens. They also have alignment markings on the peripheral part of the lens that enable the surgeon to adjust the orientation of the IOL inside the eye for optimal correction. Prior to cataract surgery, the surgeon places temporary markings on the patient's cornea that identify the location of the most curved meridian of the front of the eye.

When the toric IOL is implanted during the cataract procedure, the surgeon rotates the IOL so the markings on the IOL are aligned with the markings on the cornea to insure proper astigmatism correction. FDA-approved toric intraocular lenses available in the U.S. include: Tecnis Toric (Abbott Medical Optics), AcrySof IQ Toric (Alcon), Staar Toric IOL (Staar Surgical), and Trulign Toric (Bausch + Lomb).

Aspheric:

The shape of the natural lens inside the eye may vary in curvature from center to periphery In other words, the eye's natural lens is aspheric or not spherical. Aspheric IOLs are designed to more closely match the shape and optical quality of the eye's natural lens, and thereby can provide sharper vision, especially in low light conditions. FDA-approved IOLs include: Tecnis Aspheric (Abbott Medical Optics), AcrySof IQ (Alcon), SofPort AO (Bausch + Lomb), and Softec HD (Lenstec).

Extended Depth of Focus (EDOF):

EDOF IOLs, also referred to as Extended Range of Vision (EROV) IOL, are proposed for the treatment of presbyopia. In contrast to multifocal IOLs used in treatment of presbyopia, EDOF lenses work by creating a single elongated focal point to enhance \

Histologically, the lens is absent in primary congenital aphakia. In secondary congenital aphakia, the lens has developed but has been resorbed or extruded before or during birth.

Anisometropia, the condition in which one eye has a different refractive error than the other, can cause amblyopia. The threshold for anisometropia that is enough to cause amblyopia varies depending upon the type of refractive error. The level of anisometropia severity can be categorized into mild (SE difference ≥ 1.0 D and < 2.0 D), moderate (SE difference ≥ 2.0 D and <3.0 D), and severe (SE difference ≥ 3.0 D). Anisometropia is treated with refractive correction. Early detection of refractive anisometropia in children with timely intervention could prevent permanent impairment in binocular vision and stereopsis.

Refractive surgery may be performed in children with significant anisometropia who cannot or will not wear refractive correction. In children with extremely high refractive error in one eye only, correction with glasses causes a condition called aniseikonia (difference in image size) such that the eyes cannot function visually together. Secondarily, the children can experience asthenopia (eye fatigue, headache) from this correction and most refuse to wear the glasses. Contact lenses are another option, but they are difficult to insert in uncooperative children, loss is frequent, and they are costly. The consequence of this intolerance/noncompliance is severe amblyopia.

Literature Review

Both subjective and objective outcomes resulting from the use of varying types of IOLs have been reported in the peer-reviewed, published scientific literature (e.g., contrast sensitivity, glare acuity, pain score, up-close, medium range and distance visual acuity).

Evidence in the published, peer-reviewed scientific literature generally supports improved visual acuity resulting in a decreased need for eyeglasses, with the use of premium lenses. Generally, IOLs intended primarily for reducing an individual’s dependence on additional vision correction (e.g., eyeglasses) following cataract removal and for other conditions are not considered medically necessary. Additional vision correction may be required after insertion of premium lenses.

Monofocal IOLs are the standard treatment for replacement of the crystalline lens during cataract surgery. Intraocular lens replacement for the treatment of presbyopia, myopia, and/or other refractive correction is considered not medically necessary.

For more information on surgical treatment of refractive errors please refer to the Cigna Medical Coverage Policy Corneal Remodeling.

Professional Societies/Organizations

American Academy of Ophthalmology (AAO):

The AAO Preferred Practice Pattern® on Cataract in the Adult Eye (Miller, et al., 2022) notes:

• Intraocular lens implantation is the method of choice for correcting aphakia, unless there are specific contraindications.
• Posterior chamber IOL implantation inside the capsular bag is the optimal method for most cases.
• Cataract surgeons can choose from a wide variety of posterior chamber IOL styles and materials to find an appropriate lens to match their patients’ needs.
• Intraocular lens optic size, shape, haptic configuration, optic edge design, optic and haptic materials, and chromophore content are engineered with a variety of characteristics.
• Foldable IOLs are commonly used because of their ability to fit through small incisions, and they have largely replaced rigid polymethyl methacrylate (PMMA) posterior chamber IOLs.
• Foldable IOLs can be made from silicone, hydrophilic acrylic, and hydrophobic acrylic. All foldable IOL materials are associated with minimal giant-cell foreign-body reaction.

Surgeons should be familiar with the unique positive and negative features of each IOL type with regard to material, design, and insertion system. The AAO Refractive Surgery Preferred Practice Pattern® (Jacobs, et al., 2023) states under Intraocular surgery:

• Lenticular surgery using a variety of IOL implants has also been used to address presbyopia. After the crystalline lens is removed, the IOL can be used to provide functional distance vision as well as near vision through monofocal, aspheric, multifocal, accommodative, extended depth of focus, and light-adjustable IOLs.

There are advantages and disadvantages to each of these modalities, and the selection of the specific IOL depends on the patient’s visual needs, expectations, motivation to be less dependent on eyeglasses, and willingness to accept potential compromises.

The AAO published an Ophthalmic Technology Assessment on Multifocal and Accommodating Intraocular Lenses for the Treatment of Presbyopia (Schallhorn, et al., 2021). Results reported include:

• Presbyopia-correcting lenses were effective at improving distance and near visual acuity after cataract surgery. Near acuity at different focal lengths was related directly to the effective add power of multifocal and extended depth-of-focus (EDOF) IOLs.
• Most multifocal and EDOF lenses that were compared with a control monofocal lens demonstrated that patient-reported spectacle independence was superior to the monofocal lens.
• All patients who had multifocal and EDOF lenses implanted showed decreased contrast sensitivity and reported more visual phenomena as compared with control participants who received monofocal lenses.