1. Aetna considers punctal plugs, standard punctoplasty by electrodessication or electrocautery medically necessary for members with severe dry eyes that are not adequately treated by conservative interventions including a two or more week trial of artificial tears, ophthalmic cyclosporine (Restasis) where indicated, and adjustment to medications that may contribute to dry eye syndrome. Members must have a diagnosis of severe dry eyes (also known as dry eye syndrome, keratoconjunctivitis sicca, xerophthalmia, xerosis, or sicca syndrome) and the medical record should document objective evidence of lacrimal gland deficiency (e.g., Schirmer test or the tear break-up time test) or evidence of corneal decompensation on slit-lamp exam (i.e., an ocular surface dye staining pattern (rose bengal, fluorescein, or lissamine green) characteristic of dry eye syndrome).  

   These punctal occlusion procedures are considered experimental and investigational for treatment of contact lens intolerance and for all other indications .

2. Replacement of punctal plugs:

   Repeat punctal plug procedures are considered medically necessary for the following indications:

   1. A procedure is considered medically necessary to replace temporary  dissolvable punctal plugs with long-lasting semipermanent punctal plugs. Note: Temporary punctal occlusion with a dissolvable collagen plug that lasts one week may be medically necessary to assess the member's response to punctal occlusion. The repeat use of temporary (collagen) plugs for ongoing therapy for dry eye syndrome has no proven value;

   2. Replacement of silicone punctal plugs or other long-lasting plugs is generally not medically necessary more frequently than every six months; a more frequent replacement procedure may be medically necessary if the plug does not stay in place because the member fails to follow post-operative instructions. If punctal plugs do not stay in place because of anatomical reasons, other forms of punctal occlusion should be considered.

   3. Replacement with Flow controller punctal plugs may be considered medically necessary for persons who experience epiphoria with standard punctal plugs.

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

   5. Use of shorter-acting punctal plugs composed of resorbable materials which last three to six months (see background) may be medically necessary for persons whose dry eyes are due to temporary or seasonal conditions.  

3. Aetna considers the use of the laser to occlude the tear duct opening experimental and investigational because it has not been proven to be as effective as electrodessication or thermal cautery.

Severe dry eyes (also known as dry eye syndrome, keratoconjunctivitis sicca, xerophthalmia, xerosis, or sicca syndrome) refers to chronic dryness and resultant inflammation of the cornea and conjunctiva. Dry eye syndrome can occur alone or in conjunction with immunologic disorders such as rheumatoid arthritis, systemic lupus erythematosus, or Sjögren's syndrome.

There are three commonly used objective tests for documenting and assessing the severity of dry eyes: the Schirmer test, the Rose Bengal test, and tear break-up time. All are usually performed by ophthalmologists.

Tear production may be measured using the Schirmer test. A small piece of sterile filter paper, supplied in a standard kit, is placed in the lateral third of the lower eyelid. The extent of wetting in a given time is measured. Wetting of less than 5 mm in five minutes is considered abnormal. Use of topical anesthesia and blotting of the tear reservoir prior to the test may improve accuracy as a measure of basal tear production. The findings are typically similar in both eyes.

End-organ damage to conjunctival and corneal epithelial cells may be assessed by ocular surface staining, which stains areas of devitalized tissue. Rose bengal, lissamine green, or fluorescein dyes may be used to assess the ocular surface. To perform the Rose Bengal test, ten microliters of 1 percent Rose Bengal are instilled into the inferior fornix of the unanesthetized eye. The patient is asked to blink twice to spread the stain over the conjunctiva and cornea. Staining can then be scored by the ophthalmologist using a slit lamp. A pattern of exposure zone (interpalpebral) corneal and bulbar conjunctival staining is typically seen with aqueous tear deficiency. Lissamine green dye has a staining profile similar to that of rose bengal and may cause less ocular irritation. It is not recommended for evaluating corneal epithelial disease.

Fluorescien dye stains areas of the corneal and conunctival epithelia where there is sufficient disruption of intercellular junctions to allow the dye to permeate into the tissue. Saline-moistened fluorescein strips or 1% to 2% sodium fluorescein solution is used to stain the tear film. One to 2 minutes after instilling the eye, the ocular surface is examined through a biomicroscope using a cobalt blue filter. Staining is more intense when it is observed with a yellow filter. Mild fluoresceein staining can be observed in normal eyes and may be more prominent in the morning. Exposure-zone punctate or blotchy fluorescein staining is observed in dry eye, and staining is more easily visualized on the cornea than on the conjunctiva.

The tear break-up time (or tear clearance) provides a global assessment of the function of the lacrimal functional unit and tear exchange on the ocular surface. The test is performed by measuring breakup time and tear osmolality after instillation of fluorescein. Break-up times less than 10 seconds are considered abnormal.

The American Academy of Ophthalmology (AAO) recommends the following conservative interventions for dry-eye syndrome: elimination of exacerbating medications where feasible; ocular environmental interventions; computer work site interventions; aqueous tear enhancement with topical agents or external means; and medications. In addition, any lid abnormalities should be corrected. Punctal occlusion or tarsorraphy are indicated in severe cases of dry eye syndrome that are refractory to conservative management.

Cyclosporine ophthalmic emulsion (Restasis) has been approved by the FDA to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.  In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator.

Guidelines from the American Optometric Association (AOA, 2002) state that punctal occlusion may be necessary for persons with severe dry eyes. In its position statement on punctal occlusion for dry eye, the American Academy of Ophthalmology (AAO) affirmed that punctal occlusion is a surgical procedure, and that it is considered only in patients with moderately severe to severe dry eye when symptoms and signs of dry eye are not adequately controlled by artificial tears and adjustment of medications that may contribute to dry eye symptoms. The AAO position statement explained that patients with mild dry eye frequently do not respond to punctal occlusion, and that failure of response to artificial tears and punctal occlusion suggests other problems, such as blepharitis.

Punctal plugs provide a temporary or semi-permanent means of occluding the punctum (tear duct opening) in patients with severe dry eyes. Temporary occlusion can be performed using collagen plugs, which dissolve within one week, to determine if punctal occlusion results in epiphoria. If a trial of temporary punctual occlusion proves successful, patients may then be offered semi-permanent or permanent forms of occlusion. There is little chance that permanent occlusion would be helpful if the plugs did not decrease symptoms of dry eye syndrome.

The opening of the tear ducts (the puncta) can be permanently occluded to retain tears, although it occasionally leads to excess tearing (epiphoria). Semi-permanent (reversible) punctual occlusion can be achieved by non-dissolvable silicone punctual plugs. Less commonly, semi-permanent occlusion may be achieved by suturing the punctum. If the semi-permanent plugs help but do not remain in position, then permanent surgical punctal occlusion can be performed.

The most typical usage of plugs is in the lower two puncta, but some people have plugs in all four ducts (two lower, two upper). Punctal plugs are generally made of silicone; silicone punctal plugs last for six or more months.  More recentntly, plugs for long-term (six or more month) punctal occlusion made of thermodynamic acrylic polymer (SmartPlug) and hydrogel (Oasis FormFit plug) have been developed. 

Short-term punctal plugs, composed of absorbable synthetic materials, have been developed that last less than six months have been developed for persons with seasonal symptoms or whose dry eyes are caused by a temporary condition. Examples of short-term punctal plugs include those composed of PCL (e.g., Duraplug Extended Temporary Canalicular Inserts), which last 3 to 6 months; absorbable copolymer of glycolic and trimethylene carbonate (ProLong long term absorbable plugs), which last 3 or more months;  synthetic polydioxanone (Dissolvable VisiPlug Lacrimal Plugs), which last approximately 3 months; and synthetic collagen (Oasis extended duration absorbable, Oddesy Extend absorbable implants), which last up to 3 months.

Flow controller plugs that allow partial punctal plug occlusion may be used for persons with epiphoria from standard punctal plugs. Examples of these plugs include the FCI Perforated Plugs, and Eagle Vision Flow Controller Plugs. 

Surgical punctal occlusion (occlusive punctoplasty) may be achieved by cautery, electrodessication, simple excision, or argon laser surgery. In its position statement, the AAO 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.