MEDICAL POLICY

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DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Corneal Remodeling

Number 9.03.506

Effective Date September 27, 2013

Revision Date(s) 09/09/13; 10/09/12; 10/11/11; 12/14/10; 12/08/09; 10/09/07; 07/12/05; 02/10/04; 01/01/04; 05/13/03; 01/04/99

Replaces 9.03.02 and 9.03.07

Policy

Phototherapeutic Keratectomy (PTK)

Phototherapeutic keratectomy may be considered 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.

Phototherapeutic keratectomy may be considered medically necessary for recurrent corneal erosions when more conservative measures (e.g., lubricants, hypertonic saline, patching, bandage contact lenses, gentle debridement of severely aberrant epithelium) have failed to halt the erosions.

Phototherapeutic keratectomy is considered not medically necessary when used as an alternative to a superficial mechanical keratectomy in treating patients with superficial corneal dystrophy, epithelial membrane dystrophy, and irregular corneal surfaces due to Salzmann’s nodular degeneration or keratoconus nodules.

Investigational applications of phototherapeutic keratectomy include, but are not limited to, treatment of infectious keratitis.

Refractive Keratoplasty

Radial keratotomy (RK) may be considered medically necessary in the treatment of myopia, which cannot be corrected with lenses (eyeglasses, contacts).

Epikeratophakia may be considered medically necessary in the treatment of aphakia.

All other refractive keratoplasty procedures, including photorefractive keratectomy (PRK), automated lamellar keratoplasty (ALK), minimally invasive radial keratotomy, hexagonal keratotomy, keratomileusis and keratophakia are considered investigational.

Related Policies

9.03.01

Keratoprosthesis

9.03.22

Endothelial Keratoplasty

9.03.25

Gas Permeable Scleral Contact Lens

Policy Guidelines

Phototherapeutic Keratectomy

There is no specific CPT code for PTK.

Coding

CPT

65400

Excision of lesion, cornea (keratectomy, lamellar, partial), except pterygium

65435

Removal of corneal epithelium; with or without chemocauterization (abrasion, curettage)

65436

Removal of corneal epithelium; with application of chelating agent (e.g., EDTA)

65710

Keratoplasty (corneal transplant); anterior lamellar

65771*

Radial keratotomy

65772*

Corneal relaxing incision for correction of surgically induced astigmatism

HCPCS

S0812

Phototherapeutic keratectomy (PTK)

ICD-9

Medically Necessary

371.0

Corneal scar and opacities

371.56

Stromal corneal dystrophy

Not Medically Necessary

371.46

Nodular degeneration of cornea (i.e., Salzmann’s nodular dystrophy)

371.51

Juvenile epithelial corneal dystrophy

371.52

Other anterior corneal dystrophy

371.53

Granular corneal dystrophy

371.54

Lattice corneal dystrophy

371.60

Keratoconus, unspecified

371.61

Keratoconus, stable condition

371.62

Keratoconus, acute hydrops

Investigational

017.3

Tuberculosis of the eye

053.21

Herpes zoster keratoconjunctivitis

054.4

Ophthalmologic herpes simplex

055.71

Measles keratoconjunctivitis

077.1

Epidemic keratoconjunctivitis

090.3

Syphilitic interstitial keratitis

370.44

Keratitis or keratoconjunctivitis in exanthema

Refractive Keratoplasty

Review the member benefit booklet regarding vision services. Many Plans do not cover treatment or surgeries to improve the refractive character of the cornea, including the treatment of any results of such treatment.

Radial Keratotomy

Suggested criteria for radial keratotomy:

  • There is a correction of less than 7.0 diopters
  • There is documentation of less than 0.5 diopters change within the last year
  • There is documentation of some clinical condition that precludes use of eyeglasses or contact lenses
  • There are required occupational reasons for correct vision, e.g., airline pilot, fireman.

Radial keratotomy is performed on one eye per scheduled procedure or may require more than one procedure on one eye depending on the individual case.

*CPT code 65772 (corneal relaxing incision for correction of surgically induced astigmatism) may be performed with a radial keratotomy (CPT code 65771). In this case, 65772 is part of the radial keratotomy and should not be coded separately.

Description

Phototherapeutic Keratectomy

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.

Refractive Keratoplasty

Refractive keratoplasty is a generic term that includes all surgical procedures on the cornea to improve vision by changing the refractive index of the corneal surface. Refractive keratoplasties include the following surgeries:

  • Radial keratotomy (RK) is a surgical correction for myopia (nearsightedness). Using a high-powered microscope, the physician places microincisions (usually eight or fewer), on the surface of the cornea in a pattern much like the spokes of a wheel. The incisions are very precise in terms of depth, length, and arrangement. The microincisions allow the central cornea to flatten, thus reducing the convexity of the cornea, which produces an improvement in vision.
  • Photorefractive keratectomy (PRK) uses a computerized laser to correct myopia (nearsightedness). The excimer laser is well-suited for cornea reshaping, because the removal of just tiny amounts of tissue can produce the results needed to correct nearsightedness. The excimer laser produces a beam of ultraviolet light in pulses that last only a few billionths of a second. Each pulse removes a microscopic amount of tissue by evaporating it, producing very little heat and usually leaving underlying tissue almost untouched. Overall, the surgery takes approximately 10-20 minutes; however, the use of the laser beam lasts only 15-40 seconds.
  • Automated lamellar keratoplasty (ALK) can correct hyperopia. For the treatment of moderate farsightedness, the cornea is opened across the top to form a type of “cap” using an automated instrument. When the “cap” is positioned back into its original location on top of the eye, microscopic scar tissue is formed, causing the “cap” to bulge out, thus correcting the overly flattened cornea that is associated with hyperopia. Almost like Velcro, the cornea and “cap” adhere to each other, eliminating the need for sutures. Normally, one eye is treated at a time with about 3 to 4 weeks allowed between each eye surgery. To ease any discomfort, the eye is anesthetized with special drops, and the patient is given a mild sedative to remain relaxed and aware throughout the procedure.
  • Minimally invasive radial keratotomy (Mini-RK) is intended in cases of myopia to alter the cornea’s shape, and consequently the refraction, by reducing the millimeters of cornea that are incised.
  • Hexagonal keratotomy is a form of refractive corneal surgery used to treat naturally occurring hyperopia (far-sightedness) and presbyopia (loss of accommodation in the eyes in advancing age) following radial keratotomy. A hexagonal pattern of intersecting incisions in the cornea is used in performing this procedure.

All five of the above procedures can be used alone or in combination in order to produce the optimal result for a given patient.

  • Keratomileusis involves removing, freezing, and lathing the patient’s cornea, followed by its replacement onto the corneal bed. This surgery has been proposed for myopia and aphakic hyperopia (aphakia is the absence of the lens of the eye).
  • Keratophakia involves removing the patient’s cornea followed by placement of a lathed donor cornea beneath the recipient’s cornea, which is then reattached. This surgery has been proposed for aphakic hyperopia.
  • Epikeratophakia (lamellar keratoplasty) involves suturing a prelathed donor cornea onto the surface of the recipient’s cornea. This surgery has been proposed as a means of correcting adult and pediatric aphakia, keratoconus (a conical protrusion of the cornea, caused by thinning of the stroma and resulting in major changes in the refractive power of the eye), and myopia.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply.

Benefit Application

Refractive Keratoplasty

Review the member benefit booklet regarding vision services. Many Plans do not cover treatment or surgeries to improve the refractive character of the cornea, including the treatment of any results of such treatment.

Rationale

This policy was originally created in 1999 and updated regularly with literature review using the MEDLINE database. The most recent update covers the period of October 2012 through July 2013.

Phototherapeutic Keratoplasty

There has been no controlled clinical study that 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%). (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% 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. (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.

PTK often causes corneal scarring and loss of some of the best corrected visual acuity. However, it has become the standard of care for recurrent corneal erosions once all other measures have failed. When lubricants, hypertonic saline, patching, bandage contact lenses and gentle debridement of severely aberrant epithelium have all failed to halt the erosions, PTK may be indicated.

Kandori and colleagues reported on 4 cases of Acanthamoeba keratitis treated with excimer laser phototherapeutic keratectomy (PTK) at Osaka Medical School in Japan. These four cases with early stage Acanthamoeba keratitis resistant to medical amoebic therapy for at least 1 week and with an enlarged abscess underwent PTK. They found that after PTK, the infected corneal lesions were removed and the clinical symptoms rapidly resolved in all cases. Another 40-μm ablation was required as a result of the 1-week delay in performing PTK. There was no recurrence during the postoperative period. They concluded that when lesions are limited to about one third of the superficial corneal stromal layer, PTK could be the most beneficial option for treating Acanthamoeba keratitis, resistant to medical amoebic therapy using chlorhexidine or polyhexamethylene biguanide, because of direct removal of resistant amoebic cysts and better visual recovery without irregular astigmatism. However, the early results of this small study on PTK for infectious keratitis do not change the policy statement, which remains investigational.

Refractive Keratoplasty

Greenbaum and colleagues studied the long-term reversibility of epikeratophakia. They removed three human epikeratophakia lenticules (from three patients) 7-14 years after refractive keratoplasty for aphakia (n = 1) and myopia (n = 2). Reasons for removal were irregular astigmatism (n = 1), opacities in the graft and host cornea, and progressive myopia (n = 2). After removal, two patients underwent cataract extraction and one underwent secondary implantation of AC-IOL. Visual acuity, refraction, keratometry, and corneal topography were assessed before and after removal of the lenticule, as well as after the cataract and IOL implantation, and were compared with the initial visual acuity and corneal curvature before epikeratoplasty. After removal of the lenticule, the three patients regained the initial curvature of the cornea (pre-epikeratoplasty), and remained stable during six months of follow-up. Initial best-corrected visual acuity and refraction before epikeratoplasty were restored after removal of the epikeratoplasty lenticule in the aphakic patient. Original best-corrected visual acuity was restored in the two myopic cataract patients after cataract extraction and IOL implantation. They found that epikeratophakia was found to be a reversible procedure even after 7-14 years.

Automated lamellar KeratoplastySharma and colleagues performed a retrospective study to compare the outcomes of automated lamellar keratoplasty (ALK) and phototherapeutic keratectomy (PTK) for Salzmann nodular degeneration (SND).They studied twenty-one eyes of 21 patients who underwent ALK, and 28 eyes of 28 patients who underwent PTK. The distribution of age, pachymetry, and pretreatment corrected distance visual acuity (CDVA) was similar in both groups. In the PTK group, the mean ablation was 60.71±14.3 μm, the CDVA improved from 0.09 preoperatively to 0.21 at 6 months. None of the cases demonstrated significant scarring or any evidence of infection. In the ALK group, the mean host cut was 8.5±0.41 mm, and the donor cut was 8.64±0.45 mm, donor thickness 350 μm, and host cut 250 μm. The mean CDVA improved from 0.09 preoperatively to 0.24 at 6 months. At 6 months, 2 patients demonstrated persistently high astigmatism (>8 D), and 2 had graft interface infection. The CDVA at 6 months and the overall change in the CDVA in both the groups was similar (P=0.06 and 0.07, respectively, Mann-Whitney U test). However, the epithelialization time was significantly longer in the ALK group. They concluded that PTK for SND achieved equivalent visual results compared with ALK and may have an important keratoplasty sparing role. The incidence of complications was lesser in PTK in our study cohort.

References

  1. Summit Technology, Inc., Summary of Safety and Receptiveness Data, ExciMed UV200LA or SVVS Apex (formerly the OmniMed) Excimer Laser System for Phototherapeutic Keratectomy (PTK). Waltham, MA: Summit Technology, Inc. 1995.
  2. Maloney RK, Thompson V, Ghisell G, et al. A prospective multicenter trial of xcimer laser phototherapeutic keratectomy for corneal vision loss. The Summit Phototherapeutic Keratectomy Study Group. Am J Ophthalmol 1996; 122(2):149-60.
  3. American Academy of Ophthalmology. Basic and Clinical Science course, Section #8 – External Disease and Cornea, pages 98 – 100 and page 40. www.aao.org. Accessed September 11, 2012.
  4. Reidy J.J., Paulus MP, Gona S. Recurrent Erosions of the Cornea: Epidemiology and Treatment. Cornea.2000:19(6):767-771.
  5. National Institute for Health and Clinical Excellence (NICE). Photorefractive (laser) surgery for the correction of refractive errors. Interventional Procedure Guidance 164. London, UK:NICE;2006.
  6. AmericanAcademy of Ophthalmology Refractive Management/Intervention Panel. Preferred Practice Pattern Guidelines. Refractive Errors & Refractive Surgery. San Francisco, CA: AmericanAcademy of Ophthalmology; 2007. Available at: http://www.aao.org/ppp. Accessed September 29, 2011.
  7. Greenbaum A, Kaiserman I, Avni I. Long-term reversibility of epikeratophakia. Cornea. 2007;26(10):1210-2.
  8. Rapuano CJ. Phototherapeutic keratectomy: who are the best candidates and how do you treat them? Curr Opin Ophthalmol. 2010;21(4):280-2.
  9. Kandori M, Inoue T, Shimabukuro M, et al. Four cases of Acanthamoeba keratitis treated with phototherapeutic keratectomy. Cornea. 2010;29(10):1199-202.
  10. Sharma N, Prakash G, Titiyal JS, et al. Comparison of automated lamellar keratoplasty and phototherapeutic keratectomy for Salzmann nodular degeneration. Eye Contact Lens. 2012;38(2):109-11.

Coding

Codes

Number

Description

CPT

65400

Excision of lesion, cornea (keratectomy, lamellar, partial) except pterygium

 

65435

Removal of corneal epithelium; with or without chemocauterization (abrasion, curettage)

 

65436

; with application of chelating agent (e.g., EDTA)

 

65710

Keratoplasty (corneal transplant); anterior lamellar

 

65730

Keratoplasty (corneal transplant); penetrating (except in aphakia or pseudophakia)

 

65750

Keratoplasty (corneal transplant); penetrating (in aphakia)

 

65755

Keratoplasty (corneal transplant); penetrating (in pseudophakia)

 

65756

Keratoplasty (corneal transplant); endothelial

 

65757

Backbench preparation of corneal endothelial allograft prior to transplantation (List separately in addition to code for primary procedure)

 

65760

Keratomileusis

 

65767

Epikeratoplasty

 

65770

Keratoprosthesis

 

65771

Radial keratotomy

 

65772

Corneal relaxing incision for correction of surgically induced astigmatism

 

65775

Corneal wedge resection for correction of surgically induced astigmatism

ICD-9 Procedure

11.41

Mechanical removal of corneal epithelium

 

11.49

Other removal or destruction of corneal lesion

 

11.59

Other repair of cornea

 

11.61

Lamellar keratoplasty with autograft

 

11.62

Other lamellar keratoplasty

 

11.76

Epikeratophakia

 

16.93

Excision of lesion of eye, unspecified structure

ICD-9 Diagnosis

367.0

Hyperopia

 

367.1

Myopia

 

367.20

Astigmatism, unspecified

 

371.00

Corneal scars and opacities, unspecified

 

371.01

Minor opacity of cornea

 

371.02

Peripheral opacity of cornea

 

371.03

Central opacity of cornea

 

371.04

Adherent leucoma

 

371.05

Phthisical cornea

 

371.56

Other stromal corneal dystrophies

 

379.31

Aphakia

 

743.35

Congential aphakia

HCPCS

J7131

Hypertonic saline solution, 1 ml

 

S0812

Phototherapeutic keratectomy (PTK)

Type of Service

Vision

 

Place of Service

Outpatient

 

Appendix

N/A

History

Date

Reason

01/04/99

Add to Other Section - New Policy

05/13/03

Replace Policy - Policy status changed from BC to AR. Policy will now be reviewed without literature review.

01/01/04

Replace Policy - CPT code updates only.

02/10/04

Replace Policy - Policy reviewed without literature review; new review date only.

07/12/05

Replace Policy - Policy updated with literature review; no changes in policy statements. No further review scheduled.

05/26/06

Scope and Disclaimer update - No other changes

10/9/07

Replace Policy - Policy reviewed with literature review, new reference added. No change in policy statement.

01/13/09

Code Updates - Codes 65730, 50, 55, 56, 57; effective 1/1/09.

12/08/09

Replace Policy - BC.9.03.02 and BC.9.03.07 policies combined into new PR policy. Policies reviewed with literature search. Policy statement for PTK for recurrent corneal erosions changed from investigational to medically necessary. Rationale and References updated. Codes Added.

12/14/10

Replace Policy - Policy updated with literature review, new reference added. No change in policy statements.

10/11/11

Replace Policy - Policy updated with literature review, new reference added. No change in policy statements.

01/27/12

HCPCS code J7131 added to policy.

10/26/12

Replace policy. Policy updated with literature review, new reference added. No change in policy statements.

09/27/13

Replace policy. Rationale section reformatted. No change in policy statement.

10/16/13

Update Related Policies. Add policy 9.03.25.

03/11/14

Coding Update. Code 11.75 was removed per ICD-10 mapping project; this code is not utilized for adjudication of policy.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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