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Date Printed: August 23, 2017: 06:01 AM

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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.

02-65000-19

Original Effective Date: 02/15/15

Reviewed: 02/23/17

Revised: 03/15/17

Subject: Amniotic Membrane and Limbal Stem Cell Transplantation for the Treatment of Ocular Conditions

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    
           

DESCRIPTION:

The cornea is the clear front of the eye and its surface is composed of an epithelium, a thin layer of stratified squamous cells that form the outermost layer of the cornea. The corneal epithelium can rapidly regenerate. This regeneration relies on the existence of stem cells located in the limbal epithelium (the junction zone between the corneal and conjunctival epithelia).

Corneal epithelial defects are a focal loss of the corneal epithelium. Associated symptoms include pain, photophobia, tearing and foreign body sensation of the affected eye. These defects can occur by a variety of means, including:

There are several techniques for the management of corneal epithelial defects. For small defects, observation is an acceptable treatment, with or without topical antibiotics to prevent infection, given the mechanism of injury or provider suspicion. For large defects, bandage contact lenses and pressure patching can be administered in individuals with history of compliance and follow up. The goal of treatment is to provide comfort and prevent infection as the limbal stem cells regenerate the corneal epithelium. Topical anesthetics are not considered to be helpful in the treatment of corneal epithelial defects due to the concern for topical anesthetic abuse and masking of worsening pain.

The goal of amniotic membrane transplantation and limbal stem cell transplantation is to reconstruct damaged ocular surfaces and promote healing, decrease scarring, reduce inflammation and restore function and appearance of corneal, conjunctival and eyelid tissues after injury due to trauma, disease, or surgery.

Amniotic membrane is the innermost layer of the placenta consisting of a thick basement membrane and an avascular stromal matrix. It can be obtained from cesarean deliveries and is prepared and cryo-preserved under sterile conditions. It may be sutured into place, or placed without sutures onto the ocular surface and used as a graft and/or a dressing to facilitate ocular surface reconstruction and promote healing. Amniotic membrane contains an avascular matrix, which inhibits angiogenesis in adjacent tissues, thus minimizing vascularization during ocular healing. It exhibits anti-inflammatory properties and suppresses expression of transforming growth factor-beta (TGF-β) isoforms, minimizing scar tissue.

Limbal stem cells act as a "barrier" to conjunctival epithelial cells and normally prevent them from migrating on to the corneal surface. Limbal stem cell deficiency (LSCD) can develop in traumatic, immunologic, or genetic diseases that affect the ocular surface. LSCD leads to conjunctivalization, with corneal vascularization and opacification and subsequent loss of vision. Limbal stem cell transplantation is a surgical treatment to address LSCD and restore a corneal epithelial phenotype. Based on the source of cells, limbal transplant can be autologous or allogenic. An autograft from the individual’s undamaged eye may be used, or an allograft from a donor's eye may be used.

POSITION STATEMENT:

Amniotic membrane transplantation OR limbal stem cell transplantation meets the definition of medical necessity for the treatment of any of the following conditions when medical management (e.g., lubricants, artificial tears, steroids, antibiotics, eyelid taping, patching) has failed, is contraindicated or is not tolerated:

BILLING/CODING INFORMATION:

CPT Coding:

65778

Placement of amniotic membrane on the ocular surface; without sutures

65779

Placement of amniotic membrane on the ocular surface; single layer, sutured

65780

Ocular surface reconstruction; amniotic membrane transplantation, multiple layers

65781

Ocular surface reconstruction; limbal stem cell allograft (eg, cadaveric or living donor)

65782

Ocular surface reconstruction; limbal conjunctival autograft (includes obtaining graft)

HCPCS Coding:

V2790

Amniotic membrane for surgical reconstruction, per procedure

ICD-10 Diagnoses Codes That Support Medical Necessity:

H11.001 – H11-069

Pterygium

H11.151 – H11.153

Pinguecula

H11.21 – H11.213

Conjunctival scars

H11.221 – H11.223

Conjunctival adhesions and strands (localized)

H11.231 – H11.233

Conjunctival granuloma

H11.241 – H11.243

Symblepharon

H11.31 – H11.33

Conjunctival hemorrhage

H11.411 – H11.413

Vascular abnormalities of conjunctiva

H11.441 – H11.443

Conjunctival cysts

H11.811 – H11.819

Pseudopterygium

H16.001 – H16.049

Corneal ulcer

H16.051 – H16.053

Superficial keratitis

H16.061 – H16.079

Mycotic and perforated corneal ulcer

H16.111 – H16.113

Macular keratitis

H16.121 – H16.123

Filamentary keratitis

H16.131 – H16.133

Photokeratitis

H16.141 – H16.143

Punctate keratitis

H16.231 – H16.239

Neurotrophic keratoconjunctivitis

H16.241 – H16.243

Ophthalmia nodosa

H16.251 – H16.253

Phlyctenular keratoconjunctivitis

H16.261 – H16.263

Vernal keratoconjunctivitis, with limbar and corneal involvement

H16.311 – H16.313

Corneal abscess

H16.321 – H16.323

Diffuse interstitial keratitis

H16.331 – H16.333

Sclerosing keratitis

H16.391 – H16.393

Other interstitial and deep keratitis

H16.421 – H16.423

Pannus (corneal)

H16.431 – H16.433

Localized vascularization of cornea

H16.441 – H16.443

Deep vascularization of cornea

H17.00 – H17.03

Adherent leukoma

H17.10 – H17.12

Central corneal opacity

H17.811 – H17.813

Minor opacity of cornea

H17.821 – H17.823

Peripheral opacity of cornea

H18.021 – H18.023

Argentous corneal deposits

H18.031 – H18.033

Corneal deposits in metabolic disorders

H18.041 – H18.043

Kayser-Fleischer ring

H18.10 – H18.13

Bullous keratopathy

H18.311 – H18.313

Idiopathic corneal edema

H18.321 – H18.323

Folds in Descemet's membrane

H18.331 – H18.333

Rupture in Descemet's membrane

H18.411 – H18.413

Arcus senilis

H18.43

Other calcerous corneal degeneration

H18.441 – H18.443

Keratomalacia

H18.451 – H18.453

Nodular corneal degeneration

H18.461 – H18.463

Peripheral corneal degeneration

H18.50 – H18.59

Corneal dystrophy

H18.711 – H18.713

Corneal ectasia

H18.721 – H18.723

Corneal staphyloma

H18.731 – H18.733

Descemetocele

H18.811 – H18.813

Anesthesia and hypoesthesia of cornea

H18.821 – H18.839

Erosion of cornea

L12.30

Acquired epidermolysis bullosa, unspecified

L12.31

Epidermolysis bullosa due to drug

L12.35

Other acquired epidermolysis bullosa

L51.0 – L51.9

Erythema multiforme [Stevens-Johnson syndrome]

T26.11XD,S – T26.12D,S

Burn of cornea and conjunctival sac

T26.21D,S – T26.22D,S

Burn with resulting rupture and destruction of eyeball

T26.31D,S – T26.32,D,S

Burns of other specified parts of eye and adnexa

T26.41D,S - T2642D,S

Burn of eye and adnexa

T26.61D,S – T26.62D,S

Corrosion of cornea and conjunctival sac

T26.71D,S – T26.72D,S

Corrosion with resulting rupture and destruction of eyeball

T26.81D,S – T26.82D,S

Corrosions of other specified parts of eye and adnexa

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 Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Amniotic Membrane- Sutureless Placement on the Ocular Surface (L36237), located at fcso.com.

DEFINITIONS:

Bullous keratopathy: the presence of corneal epithelial bullae, resulting from corneal endothelial disease (failure of the corneal endothelium to maintain the normally dehydrated state of the cornea).

Hereditary aniridia: a congenital, hereditary, bilateral, extreme form of iris hypoplasia in which the iris appears absent on superficial clinical examination.

Neurotrophic keratopathy: a degenerative disease of the corneal epithelium resulting from impaired corneal innervation. Symptoms include reduction in corneal sensitivity or complete corneal anesthesia. This disease is responsible for producing epithelial keratopathy, ulceration and perforation.

Pseudopterygium: a conjunctival scar joined to the cornea; it looks like a pterygium but is not attached to the tissue.

Pterygium: a fleshy triangular growth of bulbar conjunctiva that may spread across and distort the cornea, induce astigmatism, and change the refractive power of the eye.

Stevens-Johnson syndrome: a severe cutaneous hypersensitivity reaction; drugs, especially sulfa drugs, antiepileptics, and antibiotics, are the most common causes. Macules rapidly spread and coalesce, leading to epidermal blistering, necrosis, and sloughing.

RELATED GUIDELINES:

None applicable.

OTHER:

None applicable.

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ). National Guideline Clearinghouse. Guideline Summary NGC-10113. Eye. Encinitas (CA): Work Loss Data Institute; 2013 Mar 19.
  2. American Academy of Ophthalmology EyeNet Magazine. Diagnosing and Treating Neurotrophic Keratopathy. Accessed at http://www.aao.org/publications/eyenet/200807/pearls.cfm.
  3. American Academy of Ophthalmology EyeWiki™. Amniotic Membrane Transplant. Accessed at http://eyewiki.aao.org/Amniotic_Membrane_Transplant.
  4. American Academy of Ophthalmology EyeWiki™. Application of Stem Cells for Regenerative Therapy in Cornea. Accessed at http://eyewiki.aao.org/Application_of_Stem_Cells_for_Regenerative_Therapy_in_Cornea.
  5. American Academy of Ophthalmology. Ophthalmic Pearls: Cornea. Diagnosis and Management of Limbal Stem Cell Deficiency. Authors: Vora GK, Daluvoy MB. February 2014.
  6. American Academy of Ophthalmology Preferred Practice Pattern: Bacterial Keratitis (October 2013). Acessed at http://one.aao.org/preferred-practice-pattern/bacterial-keratitis-ppp--2013.
  7. American Academy of Ophthalmology Preferred Practice Pattern: Corneal Edema and Opacification (October 2013). Accessed at http://one.aao.org/preferred-practice-pattern/corneal-edema-opacification-ppp--2013.
  8. American Academy of Ophthalmology Treatment Guideline: Herpes Simplex Virus Keratitis (June 2014). Accessed at http://one.aao.org/clinical-statement/herpes-simplex-virus-keratitis-treatment-guideline.
  9. Arya SK, et al. Simple Limbal Epithelial Transplantation in Acid Injury and Severe Dry Eye. J Clin Diagn Res. 2016 Jun;10(6):ND06-7.
  10. Atallah MR, et al. Limbal stem cell transplantation: current perspectives. Clin Ophthalmol. 2016 Apr 1;10:593-602.
  11. ClinicalTrials.gov. NCT02148016: Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation. Last verified May 2014.
  12. ClinicalTrials.gov. NCT01926535: Amniotic Membrane Graft In Syntomathic Bullous Keratopathy (AMBUK). Last verified August 2013.
  13. Eslani M, Baradaran-Rafii A, Movahedan A, Djalilian AR. The ocular surface chemical burns. J Ophthalmol. 2014;2014:196827.
  14. First Coast Service Options, Inc. (FCSO). Local Coverage Determination L36237: Amniotic Membrane- Sutureless Placement on the Ocular Surface (10/01/15).
  15. Gheorghe A, et al. New clinical application of amniotic membrane transplant for ocular surface disease. J Med Life. 2016 Apr-Jun;9(2):177-9.
  16. Guarnieri A, Moreno-Montañés J, Alfonso-Bartolozzi B, Sabater AL, García-Guzmán M, Andreu EJ, Prosper F. Quantification of corneal neovascularization after ex vivo limbal epithelial stem cell therapy. Int J Ophthalmol. 2014 Dec 18;7(6):988-95.
  17. Haagdorens M, et al. Limbal Stem Cell Deficiency: Current Treatment Options and Emerging Therapies. Stem Cells Int. 2016;2016:9798374.
  18. Health Quality Ontario. Limbal stem cell transplantation: an evidence-based analysis. Ont Health Technol Assess Ser. 2008;8(7):1-58.
  19. Kheirkhah A, Casas V, Raju VK, Tseng SC. utureless amniotic membrane transplantation for partial limbal stem cell deficiency. Am J Ophthalmol. 2008 May;145(5):787-94.
  20. Kilic M, et al. Clinical Spectrum and Treatment Approaches in Corneal Burns. Turk J Ophthalmol. 2015 Oct;45(5):182-187.
  21. Liang L, Sheha H, Li J, Tseng SC. Limbal stem cell transplantation: new progresses and challenges. Eye (Lond). 2009 Oct;23(10):1946-53.
  22. Malhotra C, Jain AK. Human amniotic membrane transplantation: Different modalities of its use in ophthalmology. World J Transplant. 2014 Jun 24;4(2):111-21.
  23. Medscape Drug and Diseases. Aniridia. January 10, 2014. Accessed at http://emedicine.medscape.com/article/1208379-overview.
  24. Meller D, Pauklin M, Thomasen H, Westekemper H, Steuhl KP. Amniotic membrane transplantation in the human eye. Dtsch Arztebl Int. 2011 Apr;108(14):243-8.
  25. Merck Manual Professional Edition. Bullous Keratopathy; Pinguecula and Pterygium; Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN); Corneal Ulcer. Accessed at http://www.merckmanuals.com/professional/eye_disorders.
  26. National Institute for Health and Care Excellence (NICE). Interventional Procedure Guidance (IPG) 216: Tissue-cultured limbal stem cell allograft transplantation for regrowth of corneal epithelium (April 2007). Accessed at http://www.nice.org.
  27. Palamar M, Kaya E, Egrilmez S, Akalin T, Yagci A. Amniotic membrane transplantation in surgical management of ocular surface squamous neoplasias: long-term results. Eye (Lond). 2014 Sep;28(9):1131-5.
  28. Prabhakar SK. Safety profile and complications of autologous limbal conjunctival transplantation for primary pterygium. Saudi J Ophthalmol. 2014 Oct;28(4):262-7.
  29. Queiroz de Paiva AR et al, Surgical Reconstruction of Ocular Surface Tumors Using Fibrin Sealant Tissue Adhesive. Ocul Oncol Pathol. 2016 Oct;2(4):207-211.
  30. Rama P, Matuska S, Paganoni G, Spinelli A, De Luca M, Pellegrini G. Limbal stem-cell therapy and long-term corneal regeneration. N Engl J Med. 2010 Jul 8;363(2):147-55.
  31. Sacchetti M, Lambiase A. Diagnosis and management of neurotrophic keratitis. Clin Ophthalmol. 2014 Mar.
  32. Schallenberg M, Westekemper H, Steuhl KP, Meller D. Amniotic membrane transplantation ineffective as additional therapy in patients with aggressive Mooren's ulcer. BMC Ophthalmol. 2013 Dec 17;13:81.
  33. Sejpal K, Bakhtiari P, Deng SX. Presentation, diagnosis and management of limbal stem cell deficiency. Middle East Afr J Ophthalmol. 2013 Jan-Mar;20(1):5-10.
  34. Sheha H, Liang L, Li J, Tseng SC. Sutureless amniotic membrane transplantation for severe bacterial keratitis. Cornea. 2009 Dec;28(10):1118-23.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/23/17.

GUIDELINE UPDATE INFORMATION:

02/15/15

New Medical Coverage Guideline.

10/01/15

Revision; updated ICD9 and ICD10 coding sections.

02/15/16

Scheduled review. Maintained position statement. Revised program exceptions section and updated references.

03/15/17

Scheduled review. Maintained position statement. Updated references. Reformatted guideline.

Date Printed: August 23, 2017: 06:01 AM