Medical Policy

Policy Num:      07.001.032
Policy Name:    Phototherapeutic  Keratectomy
Policy ID           [07.001.032]  [Ar / L / M+ / P-]  [0.00.00]

Last Review:    June 23, 2023
Next Review:    Policy Archived
 

ARCHIVED

Related Policies: None

Phototherapeutic Keratectomy

Summary

Phototherapeutic keratectomy contemplates the use of excimer laser "excited dimer" to treat visual impairment problems or irritative symptoms related to corneal diseases. This is achieved by destroying thin layers of corneal tissue in a uniform and sequential manner. Topical anesthesia is used and is performed in a medical office environment. Phototherapeutic keratectomy must be distinguished from photorefractive keratectomy, in that the latter uses the excimer laser to correct refractive errors in the human eye. (eg, myopia, astigmatism, hyperopia, and presbyopia) 

Phototherapeutic keratectomy (PTK) works by removing opacities from the anterior corneal stroma and eliminating raised corneal lesions while maintaining a smooth corneal surface.

Complications of PTK include induction of refractive errors, commonly hyperopia, scarification of the cornea, and reflexes (“glare”).

The following therapeutic indications are recognized:

·   Superficial dystrophy of the cornea (including granular dystrophy, lattice dystrophy, and Reis-Buckler dystrophy.

· Dystrophy of the basement membrane of the cornea, irregular surface of the cornea (Salzamann's      

·   Degeneration), keratoconus nodules and other irregular surfaces.

· Corneal scars and other opacities (eg post traumatic, mso-ansi-language:EN">post-surgical,mso-ansi-language:EN"> mso-ansi-language:EN">due to infections or secondary to another pathology).

Objective

This topic will review the management of corneal abrasions with Phototherapeutic Keratotomy.

Policy Statement

Phototherapeutic keratectomy is considered for payment when used as an alternative to lamellar keratoplasty in the treatment of visual or irritative problems related to to corneal scars, opacities or dystrophies that extend beyond the layer epithelial.

Phototherapeutic keratectomy is not considered for payment under the following conditions:

Tuberculosis of the eye

Keratoconjunctivitis due to Herpes zoster

Herpes simplex conjunctivitis

Measles keratoconjunctivitis

Keratoconjunctivitis epidemic 

syphilitic interstitial keratitis

Keratitis or keratoconjunctivitis in exanthema

Triple-S, Inc. will cover phototherapeutic keratectomy only in those situations where it is recognized as medically necessary as specified in this policy, in those policies that specifically cover it.

None of the refractive keratoplasties are considered for payment. This is a generic term to designate all those surgical procedures that are performed into the cornea of ​​the human eye for the specific purpose of improving vision by changing the refractive index of the corneal surface. Refractive keratoplasty includes following surgeries:

Triple-S, Inc. will cover phototherapeutic keratectomy only in those situations where it is recognized as medically necessary as specified in this policy, in those policies that specifically cover it.

None of the refractive keratoplasties are considered for payment. This is a generic term to designate all those surgical procedures that are performed into the cornea of ​​the human eye for the specific purpose of improving vision by changing the refractive index of the corneal surface. Refractive keratoplasty includes following surgeries:

 ·   Radial keratotomy (RK) is the surgical correction for myopia. The surgeon using a microscope, he makes microincisions in the cornea, in a radial way. When healing, the convexity of the central part of the cornea is reduced, improving vision.

·   Refractive keratotomy (PRK) is the use of the “excimer” laser to reshape the cornea evaporating small particles of tissue from the cornea, enough to correct myopia, hyperopia or astigmatism. This process takes 10-20 minutes. The use of laser takes between 15-40 seconds.

·   Computerized lamellar keratoplasty (ALK) in this procedure removes a slice of the most anterior part of the cornea. When repositioning and healing this increases the convexity of the cornea correcting the flattening of the cornea present in the hyperopic condition.

· Conductive keratoplasty (CK) reshapes the cornea with one or two circles parallel concentric using laser.

Policy Guidelines

There is no specific CPT code for PTK. CPT code 65400 (excision of lesion, cornea [keratectomy, lamellar, partial]) may be used. Superficial mechanical keratectomy may be coded by 65435 – 65436 (removal of corneal epithelium). CPT code 65710 describes a lamellar keratoplasty. There is a HCPCS code, S0812, that is specific for this procedure. 

Benefit Application

BlueCard/National Account Issues

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  

Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Any patient who complains of severe eye pain with photophobia and/or foreign body sensation preventing opening of the eye generally can be presumed to have a corneal epithelial defect. The provider must then first rule out penetrating trauma, and second an infectious infiltrate, especially herpes simplex virus infection.

The clinician should confirm the diagnosis of corneal abrasions with fluorescein staining only after completing a complete eye examination and excluding an open globe.

Patients with isolated corneal abrasions and the following findings should undergo prompt evaluation by an ophthalmologist on the day of presentation:

●Corneal infiltrate, white spot, or opacity suggestion ulceration (picture 2A)

●Foreign body that cannot be removed

●Hypopyon (pus in the anterior chamber) 

Urgent referral to an ophthalmologist is indicated in patients with the following physical findings at follow-up:

●A larger epithelial defect

●Purulent discharge

●A drop in vision of more than one to two lines on a Snellen chart 

●An infant or child with persistent discharge or unwillingness to keep the eye open

●Corneal abrasion that has not healed after three to four days

These findings suggest a retained foreign body, poor healing, superinfection, or infectious keratitis.

Rationale

Phototherapeutic keratectomy 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. Phototherapeutic keratectomy may be performed in the office setting using topical anesthesia. Phototherapeutic keratectomy 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, phototherapeutic keratectomy (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-surgical, 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. For example, 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.

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 percent), 64 eyes with recurrent erosion (16.1 percent) and 231 eyes with scars, opacities or other irregular surfaces (58 percent).1 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 percent were considered successes at 1 year. Among those with visual impairment, 63.4 percent were considered successes. The most common adverse effect was corneal scarring and glare, occurring in 13.7 percent and 12.2 percent of cases, respectively. The results of this trial have also been summarized by Maloney and colleagues.2 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.

Population Reference No. 1

Recurrent erosions that are particularly large or show no signs of healing in 24 hours should be referred to an ophthalmologist who may debride flaps of epithelium and may choose to use an extended wear contact lens as a bandage . Cases that do not respond to these measures can be treated with any of a number of minor surgical procedures including stromal micropuncture, epithelial debridement, polishing of Bowman’s layer, and phototherapeutic keratectomy.

Suplemental Information

N/A

References

1. Petrovich Z, Ameye F, Baert L et al. New trends in the treatment of benign prostatic hyperplasia and carcinoma of the prostate. Am J Clin Oncol 1993; 16(3):187-200.

2. Mebust WK, Holtgrewe HL, Cockett AT et al. Transurethral prostatectomy: immediate and postoperative complications. Cooperative study of 13 participating institutions evaluating 3,885 patients. J Urol, 141: 243-247, 1989. J Urol 2002; 167(1):5-9.

3. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data: ProstaLund® CoreTherm™. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P010055b.pdf. Last accessed July, 2013.

4. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data: Prolieve™ Thermodilatation System (Prolieve ™). Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030006b.pdf. Last accessed July, 2013.

5. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). TEC Assessment. 1996; (Tab 19).

6. Hoffman RM, Monga M, Elliott SP et al. Microwave thermotherapy for benign prostatic hyperplasia. Cochrane Database Syst Rev 2012; 9:CD004135.

7. Biester K, Skipka G, Jahn R et al. Systematic review of surgical treatments for benign prostatic hyperplasia and presentation of an approach to investigate therapeutic equivalence (non-inferiority). BJU Int 2012; 109(5):722-30.

8. Sponsored by Boston Scientific Corporation. Prolieve® Post-Marketing Study: Treatment of Benign Prostatic Hyperplasia (BPH) (NCT00407953). Available online at: www.clinicaltrials.gov. Last accessed June, 2013.

9. American Urological Association. Management of BPH, revised 2010. Available online at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm. Last accessed June, 2013.

10. European Association of Urology. Guidelines on the treatment of non-neurogenic male LUTS. 2011. Available online at: www.guideline.gov. Last accessed June, 2013.

Codes

Policy History

Payment Policy Guidelines

Administrative Evaluation

· Limited to one procedure per eye per lifetime.

· It will be covered according to the general characteristics applicable to the cover.

ECONOMIC IMPACT

Interqual Criteria

Policy Categorization