Summary Of Evidence

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Analysis of Evidence

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Abstract:

Posterior capsule opacification (PCO) is one of the most common problems following cataract surgery. Anterior capsule opacification (ACO) also occurs, but somewhat less commonly. Both conditions represent the anatomic correlate of a secondary cataract (SC). As capsule opacification increases, the patient begins to notice a decrease in vision that can lead to functional impairment. The approach to the management of functional impairment due to SC, whether the result of ACO or PCO, or both, is similar to that of functional impairment due to cataract. Treatment of SC is reserved for those patients who have documented functional impairment that impacts their ability to perform needed and desired activities of daily living.

The time of onset of PCO is variable, as is the frequency with which surgery to treat PCO is performed. PCO severe enough to impair function significantly and thus require surgery is uncommon within three months of cataract surgery and occurs occasionally within the first six months after the surgery. Neodymium-Yttrium-Aluminum-Garnet YAG (Nd:YAG) posterior capsulotomy after cataract extraction has been reported as high as 30% to 50% in the early 1980s to 1990s. Although the rate for some lenses and techniques remains in the 25% - 30% range, the rate for other lenses and techniques has fallen to the single digits in some series.

PCO is a consequence of modern cataract surgery, whether performed by the extracapsular technique or by phacoemulsification (PE). In the past, an invasive procedure involving incision of the capsule with a knife, e.g., discission, was necessary to remove the opacity. Now, with the availability of the Nd:YAG laser, it is possible to perform laser capsulotomy after cataract surgery as an outpatient procedure. YAG capsulotomy for PCO creates an incision in the posterior capsule that normally serves as the boundary between the lens and the vitreous humor of the eye. The laser-created incision allows the capsule to retract, eliminating the obstruction to the passage of light through the media to the retina. YAG capsulotomy is currently the predominant means of treating a secondary cataract, in contrast to discission surgery, which is now only very rarely performed in adults as a primary procedure. However, for PCO due to an extremely dense membrane, or in those patients unable to tolerate or cooperate with laser surgery, invasive discission of the opacity is still an option.

With the development of modern cataract surgery techniques, specifically the continuous curvilinear capsulorrhexis, SC can also develop from opacification of the anterior capsule with, or without, shrinkage of the surgically created anterior capsular opening. Either situation is amenable to a YAG laser anterior capsulotomy for restoration of vision as well as for the prevention of intraocular lens decentration and/or frank dislocation.

The major complications of YAG capsulotomy include elevated intraocular pressure, retinal detachment, cystoid macular edema, damage to the intraocular lens, hyphema, decentration or dislocation of the intraocular lens, corneal edema, vitreous prolapse, endothelial cell loss, uveitis, and pupillary block, among others.

This policy will only address anterior and posterior capsulotomy for secondary cataract after cataract surgery.

Indications:

Post-cataract surgery Nd:YAG laser capsulotomy is reasonable and medically necessary only to remedy a functional impairment due to opacification, to prevent possible intraocular damage from dislocation of the intraocular lens implant, or the need to evaluate and treat posterior segment pathology. The procedure will not be covered if it is performed or scheduled concurrently with cataract-removal surgery.

Capsulotomy is covered when each of the following criteria are met and clearly documented:

• The patient has decreased ability to carry out activities of daily living including (but not limited to) reading, watching television, driving, or meeting occupational or a vocational expectations; and
• The patient has a best-corrected visual acuity of 20/50 or worse at distance or near; or additional testing shows one of the following:
  
  • Consensual light testing decreases visual acuity by two lines, or
  • Glare testing decreases visual acuity by two lines; and
• The patient has determined that he/she is no longer able to function adequately with the current level of visual function; and
• Other eye disease(s), including but not limited to macular degeneration or diabetic retinopathy, has (have) been excluded as the primary cause of visual functional disability, except for the instance in which significant visual debility, in the judgement of the treating physician, is deemed secondary to ACO or PCO and laser treatment would provide the patient with improved functionality; and
• Physician concurrence with significant patient-defined improvement in visual function can be expected as a result of capsulotomy; and
• The patient has been educated about the risks and benefits of capsulotomy and the alternative(s) to surgery (e.g., the avoidance of glare, use of optimal eyeglasses prescription, etc.); and
• The patient has undergone an appropriate preoperative ophthalmologic evaluation.

For patients with a best-corrected visual acuity of 20/40 or better, anterior and/or posterior capsulotomy will be considered if all other criteria have been met and documented to support the medical necessity of the procedure for that patient.

Limitations:

YAG capsulotomy secondary to cataract extraction and intra-ocular lens placement should not be required more than once per eye. Claims for a second capsulotomy will require the patient have a non-cataract extraction related underlying diagnosis or condition that poses a high risk for re-opacification of the capsule.

Medicare recognizes the use of lasers for many medical indications. Procedures performed with lasers are sometimes used in place of more conventional techniques. In the absence of a specific noncoverage instruction, and where a laser has been approved for marketing by the Food and Drug Administration, contractor discretion may be used to determine whether a procedure performed with a laser is reasonable and necessary and, therefore, covered. The determination of coverage for a procedure performed using a laser is made on the basis that the use of lasers to alter, revise, or destroy tissue is a surgical procedure. Therefore, coverage of laser procedures is restricted to practitioners with training in the surgical management of the disease or condition being treated (CMS Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2: 140.5‎ Laser Procedures).