Tear Film Insufficiency (Dry Eyes)

Clinical Coverage Guideline page 1

Easy Choice Health Plan, Inc.

Harmony Health Plan of Illinois, Inc.

Missouri Care, Inc.

‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc.

WellCare Health Insurance of Illinois, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare Health Insurance of Arizona, Inc.

WellCare of Florida, Inc.

WellCare of Connecticut, Inc.

WellCare of Georgia, Inc.

WellCare of Kentucky, Inc.

WellCare of Louisiana, Inc.

WellCare of New York, Inc.

WellCare of South Carolina, Inc.

WellCare of Texas, Inc.

WellCare Prescription Insurance, Inc.

Windsor Health Plan

Windsor Rx Medicare Prescription Drug Plan

Tear Film Insufficiency (Dry Eyes)

Policy Number: HS-262

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.

BACKGROUND

Dry eye occurs when the eye does not produce tears properly, or when the tears are not of the correct consistency and evaporate too quickly. In addition, inflammation of the surface of the eye may occur along with dry eye. If left untreated, this condition can lead to pain, ulcers, or scars on the cornea, and some loss of vision. However, permanent loss of vision from dry eye is uncommon. Dry eye can make it more difficult to perform some activities, such as using a computer or reading for an extended period of time, and it can decrease tolerance for dry

environments, such as the air inside an airplane. Dry eye is also known as: dry eye syndrome, keratoconjunctivitis sicca (KCS), dysfunctional tear syndrome, lacrimal keratoconjunctivitis, evaporative tear deficiency, aqueous tear deficiency, and LASIK-induced neurotrophic epitheliopathy (LNE).¹

Tear film is defined as the liquid layer bathing the cornea and conjunctiva. It creates a perfectly smooth liquid outer layer that polishes the corneal surface, mechanically traps and flushes out foreign bodies and chemicals, contains bacteriostatic substances that inhibit the growth of microorganisms, and reduces the surface friction associated with eyelid blinking and eye movement.

Dry eye symptoms may include any of the following:¹

 Stinging or burning of the eye

 A sandy or gritty feeling as if something is in the eye

 Episodes of excess tears following very dry eye periods

 A stringy discharge from the eye

 Pain and redness of the eye

 Episodes of blurred vision

 Heavy eyelids

 Inability to cry when emotionally stressed

 Uncomfortable contact lenses

 Decreased tolerance of reading, computer work, or any activity that requires sustained visual attention

 Eye fatigue

Nearly five million Americans 50 years of age and older are estimated to have dry eye however, dry eye can impact anyone. Dry eye is more common after menopause. Women who experience menopause prematurely are more likely to have eye surface damage from dry eye. Dry eye can be a temporary or chronic condition resulting from any of the following:¹

 Side effect of some medications (e.g., antihistamines, nasal decongestants, tranquilizers, certain blood pressure medicines, Parkinson's medications, birth control pills and anti-depressants).

 Skin disease on or around the eyelids

 Diseases of the glands in the eyelids, such as meibomian gland dysfunction

 Pregnancy

Clinical Coverage Guideline page 3

 Allergies

 Infrequent blinking (often associated with staring at computer or video screens)

 Excessive and insufficient dosages of vitamins

 Homeopathic remedies

 Loss of sensation in the cornea from long-term contact lens

 Immune system disorders (e.g., Sjögren's syndrome, lupus, and rheumatoid arthritis)

 Chronic inflammation of the conjunctiva or the lacrimal gland

 Thyroid disease

 Exposure keratitis (when the eyelids do not close completely during sleep)

Treatment

Punctal (lacrimal) plug(s) are one option that consists of plugging the drainage holes (or small circular openings at the inner corners of the eyelids where tears drain from the eye into the nose). Punctal plugs can be inserted

painlessly by an eye care professional; the member often cannot feel them. The plugs are made of silicone or collagen, are reversible, and are a temporary measure. In severe cases, permanent plugs may be considered. In some cases, a simple surgery, called punctal cautery, is recommended to permanently close the drainage holes.

The procedure helps keep the limited volume of tears on the eye for a longer period of time.¹

Occlusive punctoplasty (surgical punctal occlusion) may be achieved by cautery, electrodessication, simple excision, or argon laser surgery. The American Academy of Ophthalmology affirmed its earlier conclusion that the preferred surgical methods of permanent punctal occlusion are electrodessication or thermal cautery, and that laser punctal occlusion should be discouraged because it is less effective and more expensive than other methods.²

A scleral shell is similar to a scleral lens, but is used as a protective covering for a shrunken, sightless eye. The scleral shell is usually hand painted to cosmetically match the other eye.

Tarsorrhaphy is a rare surgical procedure in which the eyelids are partially sewn together to protect the eye.

POSITION STATEMENT ³

Applicable To:

Medicaid Medicare

The following treatment for members with a documented diagnosis of dry eye* consists of one of the following:

 Punctal (lacrimal) plug(s); OR,

 Occlusive punctoplasty; OR,

 Scleral shell; OR,

 Tarsorrhaphy (for members with severe dry eye who have not responded to other therapies)

* Dry eye is also known as dry eye syndrome, keratoconjunctivitis sicca, xerophthalmia, xerosis, or sicca syndrome.

Measurement of tear osmolarity is considered medically necessary for determining the severity of dry eyes. Tear osmolarity is considered a key point in dry eye disease (DED) and its measurement is the gold standard in the diagnosis of dry eye.

1. Punctual Plugs

Punctal plugs, standard punctoplasty by electrodessication or electrocautery is considered medically necessary when the following are met:

 Member has a diagnosis of severe dry eyes with documented objective evidence** of lacrimal gland deficiency OR evidence of corneal decompensation on slit-lamp exam***; AND,

 Member has not responded to conservative treatment – this includes a trial of artificial tears (>2 weeks), ophthalmic cyclosporine (Restasis) where indicated, and adjustment to medications that may contribute to dry eye syndrome; AND,

** Evidence may include Schirmer test or the tear break-up time test

*** An ocular surface dye staining pattern (rose bengal, fluorescein, or lissamine green) characteristic of dry eye syndrome).

Replacement of punctal plugs is considered medically necessary when the following are met:

 Procedure consists of replacing temporary dissolvable punctal plugs with long-lasting semi-permanent punctal plugs*.

 A separate procedure for occlusion of upper puncta may be medically necessary for members with insufficient relief from occlusion of lower puncta.

 Replacement with flow controller punctal plugs for members experiencing epiphoria with standard punctal plugs.

 Replacement of silicone punctal plugs or other long-lasting plugs is generally not medically necessary more frequently than every 6 months; a more frequent replacement procedure may be medically necessary due to a plug not remaining in place due to member failure to comply with post-operative instructions. (For punctal plugs that do not stay in place due to anatomical reasons, other forms of punctal occlusion should be considered).

 Use of shorter-acting punctal plugs composed of resorbable materials that last 3 to 6 months for members whose dry eyes are due to temporary or seasonal conditions.

* Temporary punctal occlusion with a dissolvable collagen plug that lasts 1 week may be medically necessary to assess the member's response to punctal occlusion. Repeat use of temporary (collagen) plugs for ongoing therapy for dry eye syndrome is considered experimental/investigational due to a lack of clinical evidence supporting efficacy.

2. Occlusive Punctoplasty (or surgical punctal occlusion) 3. Scleral Shell

4. Tarsorrhaphy (for members with severe dry eye who have not responded to other therapies) NOTE: For surgical correction of eyelid abnormalities refer to Clinical Coverage Guideline HS-038 Blepharoplasty.

Exclusions

Punctal occlusion procedures are considered experimental and investigational for the following:

 Treatment of contact lens intolerance



Clinical Coverage Guideline page 5 In addition, the following are considered experimental and investigational for the treatment of dry eyes:

 Use of laser to occlude the tear duct opening (due to a lack of as medical evidence; electrodessication or thermal cautery is preferred)

 Tear film imaging (e.g., the Tear Stability Analysis System)

 Acupuncture

 Autologous serum tears

 Heat/massage device (e.g., LipiFlow Thermal Pulsation System)

 Intense pulsed light (IPL)

 PROSE, also called Boston® Equalens®

 Spectacle shields

 Therapeutic hydrophilic contact lenses (scleral contact lenses) CODING

Covered CPT Codes

68760 Closure of the lacrimal punctum; by thermocauterization, ligation, or laser surgery 68761 Closure of the lacrimal punctum; by plug, each

83861 Tear Osmolarity Testing for Dry Eyes HCPCS Codes – No applicable codes.

Covered ICD-9 Codes

375.15 Tear film insufficiency, unspecified

Covered Draft ICD-10-CM Diagnosis Codes

H04.121 Dry eye syndrome of right lacrimal gland H04.122 Dry eye syndrome of left lacrimal gland H04.123 Dry eye syndrome of bilateral lacrimal glands H04.129 Dry eye syndrome of unspecified lacrimal gland

*Current Procedural Terminology (CPT®) 2015 American Medical Association: Chicago, IL.

REFERENCES

1. Facts about dry eye. National Eye Institute Web site. https://www.nei.nih.gov/health/dryeye/dryeye.asp. Published August 2009. Accessed June 30, 2015.

2. Preferred practice pattern: dry eye syndrome. American Academy of Ophthalmology Web site. http://www.aao.org/preferred-practice- pattern/dry-eye-syndrome-ppp--2013. Published 2013. Accessed June 30, 2015.

3. National coverage determination: scleral shell (80.5). Centers for Medicare and Medicaid Services Web site. http://www.cms.gov. Accessed June 30, 2015.

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

7/11/2015  Approved by MPC. No changes.

8/7/2014  Approved by MPC. New.