BlueCross and BlueShield of Montana Medical Policy/Codes
Phototherapeutic Keratectomy (PTK)
Chapter: Vision
Current Effective Date: October 25, 2013
Original Effective Date: October 25, 2013
Publish Date: July 25, 2013
Revised Dates: This medical document is no longer scheduled for routine literature review and update.
Description

Phototherapeutic keratectomy (PTK) involves the use of the excimer laser to treat visual impairment or irritative symptoms relating to diseases of the anterior cornea by sequentially ablating uniformly thin layers of corneal tissue.  PTK may be performed in the office setting using topical anesthesia.  PTK must be distinguished from photorefractive keratectomy, which involves the use of the excimer laser to correct refractive errors of the eye (i.e., myopia, astigmatism, hyperopia, and presbyopia). 

Essentially, PTK functions by removing anterior stromal opacities or eliminating elevated corneal lesions while maintaining a smooth corneal surface.  Complications of PTK include refractive errors most commonly hyperopia, corneal scarring, and glare.  The U.S. Food and Drug Administration (FDA) labeling for the excimer laser identifies the following ophthalmologic therapeutic indications:

  • Superficial corneal dystrophies (including granular, lattice, and Reis-Buckler’s dystrophies.) 
  • Epithelial basement membrane dystrophy, irregular corneal surfaces (secondary to Salzmann’s degeneration, keratoconus nodules, or other irregular surfaces.)
  • Corneal scars and opacities (i.e., post-traumatic, post-infectious, and secondary to pathology.)

Although not included in the FDA labeling, there has been interest in PTK as a treatment of recurrent corneal erosions in patients who have not responded to conservative therapy with patching, cycloplegia, topical antibiotics, and lubricants.

When PTK is used to remove only the epithelial surface of the cornea, the alternative technology is mechanical superficial keratectomy (i.e., corneal scraping).  When PTK is used to remove deeper layers of the cornea, (i.e., extending into Bowman’s layer), competing technologies include lamellar keratoplasty.  In addition, candidates for PTK should have exhausted medical approaches.  Recurrent corneal erosions can be treated conservatively with lubricants, patching, bandage contact lenses, or anterior stromal punctures, while keratoconus can be treated with rigid contact lenses to correct the astigmatism.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there is any exclusion or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Medically Necessary

BCBSMT may consider PTK medically necessary when used as an alternative to a lamellar keratoplasty in the treatment of visual impairment or irritative symptoms related to corneal scars, opacities, or dystrophies extending beyond the epithelial layer.

Not Medically Necessary

BCBSMT considers PTK not medically necessary when used as an alternative to a superficial mechanical keratectomy in treating patients with:

  • Superficial corneal dystrophy; or
  • Epithelial membrane dystrophy; or
  • Irregular corneal surfaces due to Salzmann's nodular degeneration or keratoconus nodules.

Investigational

BCBSMT considers PTK experimental, investigational, and unproven may include, but are not limited to the treatment of recurrent corneal erosions and infectious keratitis.

Rationale

No controlled clinical study has directly compared PTK with other forms of treatment, including superficial keratectomy (used to treat superficial lesions), or lamellar keratoplasty (used to treat deeper lesions), or anterior stromal puncture (used to treat recurrent corneal erosions).  The FDA approval was based on data from uncontrolled trials of patients with a variety of corneal pathologies.  For example, Summit Technology presented data on 398 eyes, including 103 eyes with dystrophy (25.9%), 64 eyes with recurrent erosion (16.1%), and 231 eyes with scars, opacities, or other irregular surfaces (58%).  Outcomes included best-corrected visual acuity and/or decrease in irritative symptoms, such as pain and discomfort. Among cases undergoing PTK to increase comfort, 88.5% were considered successes at one year.  Among those with visual impairment, 63.4% were considered successes. The most common adverse effect was corneal scarring and glare, occurring in 13.7% and 12.2% of cases, respectively. The results of this trial have also been summarized by Maloney and colleagues.  Superficial mechanical keratectomy is regarded as a minimally invasive, safe, and effective procedure to remove the superficial layer of the cornea. While PTK offers a more precise and elegant method of epithelial removal, no controlled studies have demonstrated that this technological superiority results in an improved patient health benefit. The precision of PTK may be most significant when deeper corneal lesions involving Bowman's layer are present. In this situation, PTK presents a minimally invasive alternative to lamellar keratoplasty.

There are inadequate data regarding the effectiveness of PTK in treating recurrent corneal erosions and infectious keratitis.

A literature review performed for the period of 2005 through 2009 did not identify any published articles that would prompt reconsideration of the above policy. Therefore the policy statement is unchanged.

2011 Update

A search of peer reviewed literature through July 2011 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

11.41, 11.49, 11.59, 11.61-11.62, 16.93, 371.00-371.5, 371.56

Procedural Codes: 65400, 65435, 65436, S0812
References
  1. Summit Technology, Inc.  Summary of Safety and Receptiveness Data, ExciMed UV200LA or SVS Apex (formerly the OmniMed) Excimer Laser System for Phototherapeutic Keratectomy (PTK). Waltham, M.A: Summit Technology, Inc. (1995).
  2. Maloney, R.K., Thompson, V., et al.  A prospective multicenter trial of excimer laser phototherapeutic keratectomy for corneal vision loss.  The Summit Phototherapeutic Keratectomy Study Group.  American Journal of Ophthalmology (1996) 122(2):149-60.
  3. Hafner A, Langenbucher, A. et al.  Long-term results of phototherapeutic keratectomy with 193-nm excimer laser for macular corneal dystrophy.  American Journal of Ophthalmology (2005 September) 140(3):392-6.
  4. Phototherapeutic Keratectomy.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual-Archived (2005 January) Other 9.03.07.
  5. Lee, J.E., Choi, H.Y., et al.  A comparative study for mesopic contrast sensitivity between photorefractive keratectomy and laser in situ keratomileusis.  Ophthalmic Surgery, Lasers and Imaging (2006 July-August) 37(4):298-303.
  6. Baryla, J., Pan, Y.I., et al.  Long-term efficacy of phototherapeutic keratectomy on recurrent corneal erosion syndrome.  Cornea (2006) 25(10):1150-2.
  7. Pogorelov, P., Langenbucher, A., et al.  Long-term results of phototherapeutic keratectomy for corneal map-dot-fingerprint dystrophy (Cogan-Guerry) Cornea (2006) 25(7):774-7.
  8. Zaidman, G.W., and A. Hong.  Visual and refractive results of combined PTK/PRK in patients with corneal surface disease and refractive errors.  Journal of Cataract Refractive Surgery (2006) 32(6):958-61.
  9. O’Conner, J., O’Keeffe, M., et al.  Twelve-year follow-up of photorefractive keratectomy for low to moderate myopia.  Journal of Refractive Surgery (2006 November) 22(9): 871-7.
History
July 2013 New 2013 BCBSMT medical policy.
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Phototherapeutic Keratectomy (PTK)