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Date Printed: October 20, 2017: 02:06 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-65000-15

Original Effective Date: 08/15/03

Reviewed: 04/28/16

Revised: 02/15/17

Subject: Keratoplasty and Keratectomy

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    

Previous Version

           

DESCRIPTION:

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.

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.

Mechanical superficial keratectomy (corneal scraping) usually involves removal of pathological epithelial and sub-epithelial tissues.

Lamellar keratoplasty (epikeratophakia) involves suturing a pre-lathed donor cornea onto the surface of the recipient’s cornea, used as a means of correcting adult and pediatric aphakia.

Endothelial keratoplasty (EK), also referred to as posterior lamellar keratoplasty, is a form of corneal transplantation in which the diseased inner layer of the cornea, the endothelium, is replaced with healthy donor tissue. Specific techniques include Descemet stripping endothelial keratoplasty (DSEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet membrane endothelial keratoplasty (DMEK), and Descemet membrane automated endothelial keratoplasty (DMAEK).

Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK) and femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) have been proposed as alternative ways to prepare the donor endothelium.

Penetrating keratoplasty (PK), involves the creation of a large central opening through the cornea, and then filling the opening with full-thickness donor cornea that is sutured in place.

Epikeratoplasty is surgical reshaping of the cornea to correct refraction for near- or far-sightedness, either by keratomileusis, keratophakia, or radial keratotomy.

Corneal relaxing incision and corneal wedge resection are procedures performed for the correction of a surgically induced astigmatism.

POSITION STATEMENT:

Phototherapeutic keratectomy (PTK) meets the definition of medical necessity when used as an alternative to lamellar keratoplasty in the treatment of any of the following:

• Visual impairment or irritative symptoms related to corneal scars

• Opacities

• Dystrophies extending beyond the epithelial layer

Phototherapeutic keratectomy (PTK) is considered experimental or investigational for all other applications, and specifically for the treatment of recurrent corneal erosions and infectious keratitis. There are inadequate data regarding the effectiveness of PTK in treating recurrent corneal erosions and infectious keratitis.

Mechanical superficial keratectomy meets the definition of medical necessity when used for treatment of conditions affecting only the epithelial surface of the cornea.

Lamellar keratoplasty (epikeratophakia) meets the definition of medical necessity when used for the treatment of aphakia in an adult or child.

Endothelial keratoplasty (EK) (Descemet stripping endothelial keratoplasty [DSEK], Descemet stripping automated endothelial keratoplasty [DSAEK], Descemet membrane endothelial keratoplasty [DMEK], or Descemet membrane automated endothelial keratoplasty [DMAEK]) meet the definition of medical necessity when used for the treatment of endothelial dysfunction, including but not limited to:

Femtosecond laser-assisted corneal endothelial keratoplasty (FLEK), and femtosecond and excimer lasers-assisted endothelial keratoplasty (FELEK) are considered experimental or investigational. There is insufficient published clinical evidence to support safety and effectiveness.

Penetrating keratoplasty (PK) meets the definition of medical necessity when used for treatment of the following conditions:

Epikeratoplasty meets the definition of medical necessity when used for the treatment of any of the following:

Corneal relaxing and corneal wedge resection meet the definition of medical necessity when used for correction of surgically induced astigmatism.

Computerized corneal topography (92025) does not meet the definition of medical necessity when performed pre or post operatively for any non-covered procedure (e.g.,refractive eye surgery).

Correction of refractive errors is generally a contract exclusion. Therefore, the following services are not eligible for coverage:

Documentation that supports medical necessity may be needed in order to determine if the stated criteria have been met. The following information may be required documentation to support medical necessity: physician history and physical, physician operative report, and physician procedure note.

LOINC Codes:

Documentation Table

LOINC Codes

LOINC Time Frame Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician operative note

28573-4

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Physician procedure note

11505-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

BILLING/CODING INFORMATION:

CPT Coding:

65435

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

65436

Removal of corneal epithelium; with application of chelating agent (eg, EDTA)

65710

Keratoplasty (corneal transplant); anterior lamellar

65730

Keratoplasty penetrating (except in aphakia or pseudophakia)

65750

Keratoplasty (corneal transplant); penetrating (in aphakia)

65755

Keratoplasty (corneal transplant); penetrating (in pseudoaphakia)

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 (non-covered)

65765

Keratophakia (non-covered)

65767

Epikeratoplasty

65771

Radial keratotomy (non-covered)

65772

Corneal relaxing incision for correction of surgically induced astigmatism

65775

Corneal wedge resection for correction of surgically induced astigmatism

0290T

Corneal incisions in the recipient cornea created using a laser, in preparation for penetrating or lamellar keratoplasty (List separately in addition to code for primary procedure)

HCPCS Coding:

S0800

Laser in situ keratomileusis (LASIK) (non-covered)

S0810

Photorefractive keratectomy (PRK) (non-covered)

S0812

Phototherapeutic keratectomy (PTK)

ICD-10 Diagnosis Codes That Support Medical Necessity For CPT Code 65435, 65436, 65710, 65730, 65750, 65755, 65756, 65757, and 0290T:

H16.001 – H16.079

Corneal ulcer

H17.01 – H17.823

Corneal scars and opacities

H18.011 – H18.019

Anterior corneal pigmentations

H18.031 – H18.033

Corneal deposits in metabolic disorders

H18.041 – H18.043

Kayser-Fleischer ring

H18.051 – H18.069

Posterior corneal and stromal corneal pigmentations

H18.10 – H18.13

Bullous keratopathy

H18.40 – H18.49

Corneal degeneration

H18.50 – H18.59

Hereditary corneal dystrophies

H18.601 – H18.629

Keratoconus

H18.731 – H18.739

Descemetocele

H18.831 – H18.839

Specified disorders of cornea

ICD-10 Diagnosis Codes That Support Medical Necessity For CPT Code 65767:

H16.001 – H16.079

Corneal ulcer

H18.40 – H18.49

Corneal degenerations

H18.601 – H18.629

Keratoconus

H18.831 – H18.839

Recurrent erosion of cornea

H27.00 – H27.03

Aphakia

Q12.3

Congenital aphakia

Q13.4

Other congenital corneal malformations

T85.21xA – T85.29xS

Mechanical complication of intraocular lens

ICD-10 Diagnosis Codes That Support Medical Necessity For CPT Code S0812:

H17.00 – H17.9

Corneal scar and opacities

H18.59

Other hereditary corneal dystrophies

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Refractive Keratoplasty (80.7) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline review date: Computerized Corneal Topography (L33810), located at fcso.com.

DEFINITIONS:

Aphakia: absence of the crystalline lens of the eye (e.g., after surgical removal of cataracts).

Astigmatism: a defect of vision due to corneal irregularity in which the image is blurred or distorted, usually in either the vertical or the horizontal axis; not the same as near-sightedness (myopia) or far-sightedness (hyperopia), but can be in addition to near- or far-sightedness. Surgically-induced astigmatism usually occurs following cataract surgery.

Automated lamellar keratoplasty (ALK): surgical procedure to improve far-sightedness; the outer area of the cornea is opened and replaced; scar tissue creates a bulging of the cornea, thereby correcting vision in some cases.

Cataract: an opacity of loss of optical uniformity of the crystalline lens with cataract development located on a continuum extending from minimal changes of original transparency in the crystalline lens to the extreme stage of total opacity; usually associated with aging, although they may be associated with other causes (i.e., acquired or congenital childhood cataracts, traumatic, complicated, toxic and secondary after-cataract); there is no medical treatment for cataracts; treatment requires lens extraction.

Clear lens replacement (CLR): this procedure entails removing the natural lens of the eye and replacing it with an intraocular lens (IOL) implant. This procedure is essentially the same as a cataract operation with lens implant. CLR is completed prior to cataract development for the refractive advantage. CLR is a procedure that is more invasive than LASIK, PRK, and Intacs, with consequent greater potential risks.

Conductive keratoplasty (Refractec’s CK): a procedure for farsightedness (hyperopia) in people over age 40. CK utilizes the controlled release of radiofrequency (RF) energy.

Cornea: responsible for focusing light rays to the back of the eye.

Descemetocele: an out pouching of the cornea. It causes loss of structural integrity, which may lead to perforation if untreated.

Diopters: A unit of measure of the refractive power if a lens. A one-diopter lens will focus parallel light rays one meter from the lens and a two-diopter lens will focus one-half of a meter from the lens. A plus 1.0-diopter lens is convex and will converge the light rays so they focus as a visible image 1 meter past the lens. A minus 1.0-diopter lens is concave and will diverge or spread light. The minus lens will not actually focus as a visible image on an optics table. Its image is known as a virtual image and if the diverging rays were followed to their point of origin, they would focus one meter in front of the minus lens.

Farsightedness: see hyperopia.

Fuchs’ endothelial dystrophy: an inherited eye disorder that can lead to decreased vision and blindness.

Hyperopia: far-sightedness; occurs when rays of light entering the eye are brought to a focus behind the retina, as a result of the eyeball being too short from front to back.

Implantable contact lenses (phakic intraocular lenses [IOL]): under investigation as a refractive procedure that can potentially correct refractive errors (nearsightedness and farsightedness). The thin IOL implant is placed in the eye without removing the natural lens of the eye.

Intra-LASIK: an advance in LASIK surgery; it is a computer guided laser that is applied to the cornea to create a flap.

Iridocorneal endothelial (ICE) syndrome: an irregular corneal endothelium that can lead to varying degrees of corneal edema, iris atrophy, and secondary angle-closure glaucoma.

Kerato: cornea (the clear outer layer of the center of the eye).

Keratoconus: thinning of the cornea causing a cone-shaped bulging of the cornea, usually bilaterally; can by corrected by glasses, contact lenses, or surgery.

Keratoectasia: bulging forward of the cornea.

keratomileusis: involves removing, freezing, and lathing the patient’s cornea, followed by its replacement onto the corneal bed. This surgery ahs been proposed for myopia and aphakic hyperopia.

Keratopathy: any non-inflammatory disease of the eye (cornea).

Keratophakia: involves removing the patient’s cornea followed by placement of a lathed donor cornea within the recipient’s cornea stroma. This surgery has been proposed for aphakia.

Keratoplasty: the replacement of abnormal host tissue by donor corneal tissue.

Keratoprosthesis: an artificial cornea intended to provide vision to patients with severe bilateral corneal disease.

Lamellar: thin layer, refers to the outermost layers of the cornea.

Laser thermal keratoplasty (LTK): similar to conductive keratoplasty, but is done with a laser.

LASIK® (laser in situ keratomileusis): reshapes the surface of the cornea with an excimer laser to focus visual images directly onto the retina and improve visual acuity.

Limbal relaxing incisions (LRI): a modification of astigmatic keratotomy (AK), which is a procedure to treat astigmatism.

Myopia: near-sightedness; a condition of the eye in which images are formed in front of the retina, resulting in a blurred image.

Nearsightedness: see myopia.

Photorefractive keratectomy (PRK): laser surgery to improve myopia by removing small amounts of tissue to flatten the cornea; lasts 10-20 minutes.

Phototherapeutic keratectomy (PTK): laser surgery to treat visual impairment or irritating symptoms relating to diseases of the cornea, by removing thin layers of corneal tissue.

Presbyopia: alteration of vision occurring with age, difficulty accommodating easily when changing focus between near objects and distant objects.

Radial keratotomy (RK): surgical treatment for myopia where approximately eight slits are made on the surface of the cornea, i.e., spokes of a wheel, resulting in flattening of the cornea.

Refraction: the measure of refractive error, which can be used to prescribe glasses and contacts.

Refractive keratoplasty: any surgical procedure performed to improve vision, involving changing the shape of the cornea.

Retina: the layer of tissue lining the inside of the back of the eye. The retina contains millions of photoreceptor cells, which convert light into images.

RELATED GUIDELINES:

Implantation of Intrastromal Corneal Ring Segments, 09-V0000-02

OTHER:

Other names used to report refractive keratoplasty:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Automated Keratotomy
Conductive Keratoplasty (CK)
Keratoplasty, endothelial
Epikeratophakia
Epikeratoplasty
Excimer Laser Photorefractive Keratectomy
Hexagonal Keratotomy
Intra-Lasik
Keratectomy, Excimer Laser Photorefractive
Keratomileusis
Keratophakia
Keratoplasty, Refractive
Lamellar Keratoplasty
Laser In Situ Keratomileusis (LASIK)
Laser Thermoplasty
Mini-RK (Minimally Invasive Radial Keratotomy)
Ocular Implants
Photorefractive Keratectomy (PRK)
Radial Keratotomy (RK)

REFERENCES:

  1. American Academy of Ophthalmology (January 2002). American Academy of Ophthalmology Issues Assessment of LASIK for correction of Myopia and Astigmatism.
  2. American Academy of Ophthalmology, Ophthalmic Technology Assessment: Deep Anterior Lamellar Keratoplasty as an Alternative to Penetrating Keratoplasty, A Report by the American Academy of Ophthalmology, accessed at: aao.org 04/27/11.
  3. American Academy of Ophthalmology, Ophthalmic Technology Assessment: Descemet’s Stripping Endothelial Keratoplasty; Safety and Outcome OTA, A Report by the American Academy of Ophthalmology, accessed at: aao.org 04/27/11.
  4. American Academy of Ophthalmology. Preferred Practice Patterns™ – Refractive Errors (2002). Accessed 06/20/07.
  5. Blue Cross Blue Shield Association Medical Policy – Refractive Keratoplasty 9.03.02 (10/31/96) (retired 12/02).
  6. Blue Cross Blue Shield Association, Medical Policy Reference Manual, 9.03.22, Endothelial Keratoplasty.March 2016.
  7. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination for Refractive Keratoplasty, Publication 100-3, Section 80.7.
  8. Coding Companion for Ophthalmology Ingenix 4th Edition, current edition.
  9. Corneal Transplantation: Corneal Disorders. Merck Manuals Online Medical Library. Last review/revision October 2008 by Melvin I. Roat, MD.
  10. Council for Refractive Surgery Quality Assurance (January 2003). Glossary of Vision and Refractive Surgery Terms (diopter). Accessed 04/02/03.
  11. El-Husseiny M, et al. Excimer versus Femtosecond Laser Assisted Penetrating Keratoplasty in Keratoconus and Fuchs Dystrophy: Intraoperative Pitfalls. Journal of Ophthalmology Volume 2015, Article ID 645830.
  12. Eye MD Link (2002) – Refractive Surgery. Accessed 03/12/03.
  13. First Coast Service Options, Inc. (FCSO). Local Coverage Determination Computerized Corneal Topography (L33810). 10/01/15. Revised 02/24/16.
  14. First Coast Service Options, Inc. Local Coverage Article for Descemet’s Stripping endothelial Keratoplasty – Coding and Billing (A48454), 02/02/09.
  15. Florida Medicare Part B Medical Policy – Cataract Extraction (01/01).
  16. Florida Medicare Part B Medical Policy – Corneal Relaxing Incisions (02/98) (retired 09/04).
  17. Hammer CM, et al. Corneal tissue interactions of a new 345 nm ultraviolet femtosecond laser. Journal of Cataract & Refractive Surgery. 2015 Jan 6;41(6):1279-88.
  18. Hayes Medical Technology Directory – Laser in Situ Keratomileusis (09/02) – updated 10/03/06.
  19. LASIK In America Web site 2000.
  20. Lee WB, Jacobs DS, Musch DC, et al. Descemet's stripping endothelial keratoplasty: safety and outcomes: a report by the American Academy of Ophthalmology. Ophthalmology. Sep 2009;116(9):1818-1830.
  21. Maier P, Reinhard T, Cursiefen C. Descemet stripping endothelial keratoplasty--rapid recovery of visual acuity. Deutsches Ärzteblatt international. 2013 May;110(21):365.
  22. Medicare National Coverage Determinations Manual, Chapter 1, Part 1, Coverage Determinations (Sections 10-80.12), accessed at: cms.gov 04/26/11.
  23. National Institute for Health and Clinical Excellence (NICE). Corneal endothelial transplantation. Interventional Procedures Consultation. London, UK: NICE; December 2008.
  24. Terry MA, Ousley PJ. Endothelial replacement without surface corneal incisions or sutures: topography of the deep lamellar endothelial keratoplasty procedure. Cornea 2001; 20:14-18.
  25. Terry, M.A., Ousley, P.J. Deep lamellar endothelial keratoplasty visual acuity, astigmatism, and endothelial survival in a large prospective series. Ophthalmology, September 2005; 112(9): 1541-8.
  26. Terry, M.A., Shamie, N., Chen, E. S., Hoar, K, Friend, D.J. Endothelial Keratoplasty: A Simplified Technique to Minimize Graft Dislocation, Iatrogenic Graft Failure, and Pupillary Block. j.ophtha. Volume 115, Issue 7, Pages 1179-1186 (July 2008).
  27. Wacker K, Baratz KH, Maguire LJ, et al. Descemet stripping endothelial keratoplasty for fuchs' endothelial corneal dystrophy: five-year results of a prospective study. Ophthalmology. Jan 2016;123(1):154-160.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/28/16.

GUIDELINE UPDATE INFORMATION:

09/15/01

Medical Coverage Guideline reformatted and revised.

11/15/01

MCG revised to include references to phototherapeutic keratectomy (PTK).

08/15/03

Annual review. Revised/new MCG; developed separate guideline for Refractive Keratoplasty.

08/15/05

Review. Deleted info on correction of post-surgical astigmatism; updated references.

02/15/06

Revision consisting of removal of information regarding INTACS and intrastromal corneal rings (new MCG 09-V0000-02 was developed for Implantation of Intrastromal Corneal Ring Segments).

11/15/06

Added coverage statement for 65772 and 65775. Added 4th and 5th digit to 370. Added 4th digit to 371.3 and 371.4. Updated references.

07/15/07

Scheduled review; reformatted guideline; updated references.

07/30/08

Added code 65755.

01/01/09

Annual HCPCS coding update: added codes 65710 and 65730.

04/29/09

Add CPT code 92025 and statement for computerized corneal topography.

07/15/09

Scheduled review; add CPT code 65756 and 65757, and add endothelial keratoplasty to position statement. Update references. Revise description section. Revise guideline title.

10/15/10

Revision; related ICD-10 codes added.

06/15/11

Scheduled review; position statements maintained and references updated.

07/15/11

Revision; formatting changes.

01/01/12

Annual HCPCS coding update. Added 0289T and 0290T.

05/11/14

Revision: Program Exceptions section updated.

10/01/15

Revision; updated ICD9 and ICD10 coding sections.

11/01/15

Revision: ICD-9 Codes deleted.

05/15/16

Scheduled review, Revise MCG title, description, position statement, CPT, HCPCS, and ICD10 coding sections, and definitions.. Update references.

01/01/17

Annual CPT/HCPCS update. Deleted 0289T.

02/15/17

Revision; added statement regarding computerized corneal topography.

Date Printed: October 20, 2017: 02:06 PM