Humana Ocular Surface Disease Diagnosis and Treatments Form

Description

The surface layers of the eye consist of the conjunctiva, the sclera (clear covering over the white of the eye) and the cornea (clear covering over the iris and pupil). Both the conjunctiva and cornea are covered by a layer called the epithelium, which completely regenerates every three to 10 days, requiring constant renewal of cells in order to remain healthy. In eyes with ocular surface disease, the epithelium is damaged, and treatment depends on the underlying cause.

Meibomian glands are sebaceous (oil) glands along the edge of the eyelids near the eyelashes. They secrete meibum, the oil found in the superficial layer of the tear film which prevents it from evaporating. Meibomian gland dysfunction may cause the eye to feel less lubricated and dry.

Ocular Surface Disease Diagnosis and Treatments

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 2 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Dry eye syndrome (also known as dry eyes, dysfunctional tear syndrome, keratitis sicca, keratoconjunctivitis sicca, xerophthalmia or xerosis), is an example of an ocular surface disease and refers to chronic dryness, inflammation and irritation of the cornea and conjunctiva. Dry eye syndrome can occur alone or in conjunction with autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematosus or Sjogren’s syndrome. Dry eye syndrome occurs when the eye cannot maintain a normal layer of tears to coat the cornea and conjunctiva. Tear fluid provides lubrication to cleanse and moisten the surface of the eye and contains enzymes which protect the eye against bacteria. Dry eye syndrome is generally due to decreased tear production and/or excessive evaporative loss which may have underlying causes such as anatomical abnormalities, medication side effects or other ocular conditions.

Dry eye syndrome is generally classified as mild, moderate or severe. Although most individuals with dry eyes will experience discomfort, some may be relatively asymptomatic or notice symptoms intermittently.

In severe cases, dry eye symptoms that are unresponsive to treatment may indicate a more serious underlying condition. A nonhealing corneal epithelium may lead to persistent corneal epithelial defects, corneal inflammation or infection and may increase the risk of corneal ulcers.

Dry eye syndrome is diagnosed primarily on the basis of reported symptoms and supporting findings upon history and physical exam. There is no single diagnostic test or set of tests to confirm or rule out the condition. Examples of methods often used to evaluate the ocular surface include, but may not be limited to:

• Immunoassay (InflammaDry) uses a tear sample to detect the inflammatory marker matrix, metalloproteinase-9 (MMP-9), which may be elevated in the tears of individuals with dry eye disease. (Refer to Coverage Limitations section)

(function) of meibomian glands. Near-infrared dual imaging uses reflective and transilluminated light purportedly to improve meibography techniques (reduce time and discomfort) and enhance results. The LipiScan is one example of a meibography device. The LipiView II is an example of a meibography device capable of ocular surface interferometry involving a three-mode ophthalmic

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 3 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.camera for imaging the lipid layer of the tear film, meibomian glands, ocular surface and eyelids. In the ocular imaging mode, the device captures high resolution images or video of the ocular surface or eyelids. The lipid imaging mode uses white light interferometry to provide a video color assessment of the tear film distribution over the cornea during blinking. The gland imaging mode relies on near-infrared illumination reflected by the meibomian glands to obtain an image. (Refer to Coverage Limitations section)

• Ocular surface dye staining uses fluorescein to stain for areas of discontinuity in the epithelial surface of the cornea. Lissamine green and Rose Bengal are used to stain areas of devitalized epithelium in the cornea and conjunctiva as well as to determine abnormalities in the tear meniscus height.
• Phenol red thread test is similar to the Schirmer test (see below) but uses special red thread instead of paper and no numbing drops are used. The red thread is placed into the lower eyelid, the eyes are gently closed and after approximately five minutes, the thread is removed and evaluated for moisture.
• Schirmer test (tear test) involves the numbing of both eyes and the placement of a special paper strip inside each lower eyelid. The eyes are then gently closed for approximately five minutes and the paper is then removed and evaluated for moisture.
• Slit lamp evaluation is used to examine and assess the conjunctiva, cornea and eyelids.
• Tear break-up time test (fluorescein eye stain) uses orange dye on a piece of blotting paper which is placed on the surface of the eye. Blinking spreads the dye to coat the tear film (protective layer) of the eye. The eye is then examined under a blue light.
• Tear osmolarity is the measurement of the salt concentration in the tear fluid.

Individuals are often educated in self-management and environmental coping strategies to alleviate early symptoms of mild dry eyes. These approaches are generally recommended regardless of the severity of the condition or other treatments in progress. Examples include, but may not be limited to, the following:

• Avoidance of air currents, fans or vents
• Frequent blinking when reading or using computer
• Frequent breaks from visually demanding tasks
Increasing ambient humidity with humidifiers Moisture chamber spectacles or eyeglass side shields
• Over-the-counter (nonprescription) topical lubricant eye drops, gels, ointments
• Warm compresses

For moderate cases of dry eye syndrome, topical anti-inflammatory agents (e.g., nonsteroidal anti-inflammatory or corticosteroid drops) or other prescription medications may be used. Procedures may be necessary when medical treatments have failed. Examples of treatments for dry eye syndrome or severe ocular surface disease include, but may not be limited to, the following:

• Amniotic membrane graft uses sterilized cryopreserved or dehydrated tissue from the amnion (innermost layer of the placenta) to reconstruct damaged ocular surfaces and promote healing (e.g., Ambio2, Ambio5, AmbioDisk, AmnioGraft, Prokera Classic, Prokera Clear, Prokera Plus, Prokera Slim).
• Autologous eye drops (autologous serum tears) have been proposed for dry eye syndrome and are made by mixing the individual’s serum with other substances.

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 4 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Bandage contact lens is a regular-sized contact lens (usually soft) without refractive power that acts as a protective barrier and helps maintain a moist corneal surface to promote healing. The lens is not intended to correct vision and is generally temporary.
• Conjunctival flap involves the surgical removal and relocation of a thin flap of conjunctiva to cover damaged corneal tissue and to provide mechanical and nutritional support in order to facilitate healing.
• Electromechanical neurostimulation (eg, iTear) is applied externally to the side of the nose above the nostril to deliver electrical currents via an oscillating tip. This is purported to stimulate the lacrimal gland to increase tear production via vibratory stimulation of the external nasal nerve in adults.
• Electrothermal heat (eg, TearCare System) is applied to the upper and lower eyelids via a wearable device, which offers a patented open-eye feature, purported to work with the eyes natural blinking to facilitate clearing of meibomian gland obstructions while in a liquid state. Following the thermal eyelid treatment, the provider may remove any residual gland obstruction with a single-use clearing instrument (similar to blunt-tipped tweezers or forceps) provided with each pair of eyelid devices.
• Intense pulsed light (IPL) delivers bursts of light at specific wavelengths. The light energy is converted to heat which warms the meibomian glands, potentially improving their function and facilitating the release of the meibum inside. IPL has been associated with initial improvement of dry eye symptoms caused by meibomian gland dysfunction, but effectiveness is not consistently sustained with prolonged treatment duration. A standard protocol for frequency and duration of IPL therapy has not been established.
• Intraductal probing (eg, Maskin protocol) is performed by applying local or topical anesthetic and introducing a thin stainless-steel wire probe into the meibomian gland orifices to forcefully expel any obstructing material and restore patency.
• Prosthetic replacement of the ocular surface ecosystem (PROSE), also called the Boston Equalens, is a type of fully customized gas permeable hard scleral contact lens for use in individuals with irregular astigmatism and severe dry eye symptoms when all standard available treatments have been exhausted. Extensive customized fitting is required.
• Punctal plugs are placed in the puncta to slow the loss of tears from the eye’s surface. The plugs may be temporary (made of dissolvable collagen or absorbable material) or semi-permanent (made of silicone). If the plugs are effective, the openings to the lacrimal drainage system may be surgically closed (occlusive punctoplasty or closure of the lacrimal punctum).
• Scleral shells are used as an artificial support and protective covering for a shrunken, sightless or damaged eye.

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 6 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• The scleral shell may serve as a protective barrier against tear evaporation and is usually hand painted to cosmetically match the other eye.
• Tarsorrhaphy is the temporary or permanent surgical fusion of the upper and lower eyelid margins to protect the cornea in conditions causing incomplete eyelid closure (eg, Graves’ disease, Bell’s palsy) or to facilitate healing of difficult to treat corneal lesions.
• Therapeutic hydrophilic contact lenses (scleral contact lenses) (eg, BostonSight) are larger in diameter than regular contact lenses, allowing tear reservoirs to form under the lenses, thereby keeping the corneas lubricated. A scleral lens is typically used to improve vision in persons with corneal irregularities. Unlike conventional contact lenses, scleral lenses rest completely on the sclera, the outer white portion of the surface of the eye, to create a fluid-filled space or reservoir over the affected cornea. This smooth liquid overlay fills in bumps on the corneal surface to improve vision.
• Thermal pulsation systems (eg, iLux, LipiFlow) are devices that purport to treat dry eye via the application of localized heat to the inner eyelid surface and intermittent pressure to the outer eyelid. The iLux has the additional capability to capture and save digital images and video of the meibomian glands. (Refer to Coverage Limitations section)

For information regarding coverage determination/limitations for eyelid conditions or treatments not addressed in this medical coverage policy, please refer to the following:

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 7 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 8 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Dry Eyes

Humana members may NOT be eligible under the Plan for the following methods of diagnosing dry eye syndrome:

• Immunoassay for inflammatory marker matrix, metalloproteinase-9 (MMP-9) tear sample test (InflammaDry); OR
• Meibography using near-infrared dual imaging or interferometry (LipiScan, LipiViewII)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the treatment of dry eyes due to decreased tear production and/or increased evaporative loss by any method other than those listed above. This includes, but may not be limited to:

• Autologous serum tears; OR
• Electromechanical neurostimulation (iTear); OR
• Electrothermal heat (eg, TearCare System); OR
• Intense pulsed light (IPL); OR
• Intraductal probing; OR
• Thermal pulsation systems (eg, iLux, LipiFlow) or similar heat/massage device

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Ocular Surface Disease Diagnosis and Treatments

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 9 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for the treatment of dry eyes due to decreased tear production and/or increased evaporative loss by the following methods:

• Moisture chamber spectacles or eyeglass side shields; OR
• PROSE, also called Boston Equalens; OR
• Therapeutic hydrophilic contact lenses (scleral contact lenses) (eg, BostonSight)

Contact lenses and services related to vision, as defined in the member’s individual certificate, are generally excluded. In the absence of a certificate exclusion, these are considered not medically necessary. Please refer to the member’s individual certificate for the specific definition.

Note: The criteria for therapeutic hydrophilic contact lenses are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Determination

Severe Ocular Surface Disease/Persistent Epithelial Defects

The treatment of complications from noncovered services (eg, contact lens wear, vision corrective procedures) may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage.

Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of dry eye syndrome.

Humana members may be eligible under the Plan for the following methods of diagnosing severe ocular surface disease:

• Ocular surface dye staining (eg, fluorescein, lissamine green, Rose Bengal)
• Phenol red thread test
• Schirmer test (tear test)
• Tear break-up time test
• Tear Osmolarity

Ocular Surface Disease Diagnosis and Treatments

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 10 of 20

Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for treatment of severe ocular surface disease resulting in persistent epithelial defects when the following criteria are met:

• Documented failure of, intolerance to or contraindication to treatment using conventional medical management (at least two prescription topical medications, other medical management or treatments listed above); AND
• Treatment consists of the following:
  • Amniotic membrane graft (eg, Ambio2, Ambio5, AmbioDisk, AmnioGraft, Prokera Classic, Prokera Clear, Prokera Plus, Prokera Slim); OR
  • Bandage contact lens (without vision correcting refractive power); OR
  • Conjunctival flap; OR
  • Surgical correction of eyelid abnormalities that are the confirmed cause of corneal exposure/severe ocular surface disease; AND
  • Therapeutic hydrophilic contact lenses (scleral contact lenses) (eg, BostonSight) (without vision correcting refractive power); AND
• Treatment is for any of the following conditions:
  • Bullous keratopathy
  • Chemical or thermal burns to cornea
  • Pterygium
  • Recurrent corneal abrasions, erosions, ulcers, wounds
  • Recurrent severe keratitis (eg, autoimmune, bacterial, exposure, neurotrophic, viral)
  • Stevens-Johnson syndrome
  • Trauma

Ocular Surface Disease Diagnosis and Treatments

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 11 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for prosthetic replacement of the ocular surface ecosystem (PROSE), also called the Boston Equalens, when the following criteria are met:

• Severe ocular surface disease resulting in persistent epithelial defects (nonhealing corneal epithelium) refractory to treatments above (amniotic membrane graft, bandage contact lens, conjunctival flap, surgical correction of eyelid abnormalities) or these are not indicated; AND
• Twelve-week trial with a scleral contact lens has failed

Coverage Limitations

Severe Ocular Surface Disease/Persistent Epithelial Defects

Humana members may NOT be eligible under the Plan for the following methods of diagnosing severe ocular surface disease:

• Immunoassay for inflammatory marker matrix, metalloproteinase-9 (MMP-9) tear sample test (InflammaDry); OR
• Meibography using near-infrared dual imaging or interferometry (LipiScan, LipiViewII)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for treatment of severe ocular surface disease resulting in persistent epithelial defects for any condition or by any method other than those listed above. This is considered experimental/ investigational as it is not identified as widely used and generally accepted as effective for any other proposed use as reported in nationally recognized peer- reviewed medical literature published in the English language.

Ocular Surface Disease Diagnosis and Treatments

Effective Date: 12/14/2023

Revision Date: 12/14/2023

Review Date: 12/14/2023

Policy Number: HUM-0504-017
Page: 12 of 20

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Additional Information about Dry Eye Syndrome, Meibomian Gland Dysfunction, Ocular Surface Disease or Other Eye Conditions May Be Found From the Following Websites:

Background

• American Academy of Ophthalmology
• National Eye Institute
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.