Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Refractive Keratoplasty
Policy #:MA11.008d

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.


MEDICALLY NECESSARY

Keratoplasty is considered medically necessary and, therefore, covered when used to treat lesions of the cornea causing abnormalities in the eye (e.g., phototherapeutic keratectomy that removes scar tissue from the visual field).

The Boston (Dohlman-Doane) Keratoprothesis (Boston KPro) is considered medically necessary for the surgical treatment of corneal opacification in individuals who meet the following criteria:
  • Cadaveric corneal transplants have failed or have a very low likelihood of success.
  • The cornea is severely opaque and vascularized AND
  • Best-corrected visual acuity is 20/400 or less in the affected eye and 20/40 or less in the contralateral eye AND
  • No end-stage glaucoma or retinal detachment is present AND
  • The individual has one of the following indications:
    • History of 1 or more corneal transplant graft failures.
    • Stevens-Johnson syndrome.
    • Ocular cicatricial pemphigold.
    • Autoimmune conditions with rare ocular involvement.
    • Ocular chemical burns.
    • An ocular condition unlikely to respond favorably to primary corneal transplant surgery (eg., limbal stem cell compromise or postherpetic anesthesia).

NOT COVERED

Radial keratotomy and keratoplasty for the purpose of refractive error compensation is considered a substitute or alternative to eyeglasses or contact lenses, which are specifically excluded by Medicare because they are considered to be cosmetic. Therefore, radial keratotomy and keratoplasty to treat refractive defects in place of eyeglasses or contact lenses are not covered.
  • An exception to this may occur in certain cases in connection with cataract surgery.

Radial keratotomy and keratoplasty that do not meet the medical necessity criteria listed in this policy are considered cosmetic services. Services that are cosmetic are excluded for the Company’s Medicare Advantage plans because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

EXPERIMENTAL/INVESTIGATIONAL

Corneal collagen cross-linking for the treatment of keratoconus is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Keratoprosthesis with any other device other than the Boston KPro is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Policy Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, refractive keratoplasty is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

Services that are cosmetic are excluded for the Company’s Medicare Advantage plans because they are not covered by Medicare. Therefore, they are not eligible for reimbursement consideration.

Description

Refractive keratoplasty is surgery to reshape the cornea of the eye to correct vision problems such as myopia (nearsightedness) and hyperopia (farsightedness). Refractive keratoplasty procedures include keratomileusis, in which the front of the cornea is removed, frozen, reshaped, and stitched back on the eye to correct either near or farsightedness; keratophakia, in which a reshaped donor cornea is inserted in the eye to correct farsightedness; and radial keratotomy, in which spoke-like slits are cut in the cornea to weaken and flatten the normally curved central portion to correct nearsightedness.

Collagen cross-linking of the cornea (CXL): in this treatment, the ophthalmologist detaches the corneal epithelium and treats the corneal stroma with an ophthalmic solution containing the photosensitizer riboflavin (vitamin B2) and then irradiates the area with UV-A light.

A keratoprosthesis is an artificial cornea intended to restore vision in individuals with severe bilateral corneal disease for whom the standard surgical intervention (a corneal transplant, performed via penetrating keratoplaty–PK) is contraindicated. A Keratoprosthesis consists of a central optic held in a cylindrical frame. The device replaces the section of the cornea that has been removed, and, along with being held in place by the surrounding tissue, may be covered by a membrane to further anchor the prosthesis.There are currently two FDA-approved keratoprostheses: the Boston (Dohlman-Doane) keratoprosthesis (Boston KPro), and the AlphaCor ® (Chirila keratoprosthesis). Available outcomes data for the two devices suggest that the Boston KPro is associated with fewer complications.
  • In 2015, the American Academy of Ophthalmology (AAO) published the findings of a systematic review into the safety and efficacy of the Boston KPro. The study’s inclusion criteria were: language of publication, English, and, in the case of retrospective studies, a collective sample size of at least 25 eyes. The search ultimately yielded 22 observational studies but no RCTs. In terms of outcomes, the study found that the proportion of patients with visual acuity of 20/200 after surgery ranged from 54% to 84% in the 10 studies reporting this outcome. Five studies reported that 11% to 39% of treated eyes attained visual acuities of 20/40 or better. In terms of safety and durability outcomes, the review found 14 studies reporting on retention rates (eyes retaining the KPro device without loss, extrusion or dehiscence of the device); retention rates ranged from 65% to 100% (mean, 88%). The most common reasons for KPro loss were corneal melts with device exposure or extrusion, endophthalmitis, infectious keratitis, or corneal ulceration. The most common complication was retroprosthetic membrane formation, which ranged from 1% to 65% (mean, 30%) in the 13 studies reporting complications.
  • A 2011 study by Jeraskova et al. reported on the long-term results of AlphaCor implantations (n = 15). The survival rate of the device at one, two, and three years was 87%, 58%, and 42%, respectively. Postoperative visual acuity ranged from hand movement to 0.8. The most significant complications were stromal melt (n =9), optic deposition (n = 3), and retrospective membrane formation (n = 3). The most common device-unrelated complication was trauma ( n = 3). All complications were managed without eye loss. The authors concluded that Alphacor provides a treatment option for individuals with corneal blindness in whom donor tissue graft would not succeed.

References

Abad JC, Vargas A. Gaping of radial and transverse corneal incisions occurring early after CXL. J Cataract Refract Surg. 2011;37(12):2214-2217.

Ahmad S, Mathews PM, Lindsley K, et al. Boston Type 1 Keratoprosthesis versus repeat donor keratoplasty for corneal graft failure: a systematic review and meta-analysis. Ophthalmology. 2016;123(1):165-177.

American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Pattern® Guidelines. Corneal Ectasia. San Francisco, CA: American Academy of Ophthalmology; 2018. Available at: https://www.aao.org/preferred-practice-pattern/corneal-ectasia-ppp-2018. Accessed September 11, 2019.

American Academy of Ophthalmology. EyeWiki™. Corneal Collagen Cross-Linking. (Revised 02/14/2019). Available at: http://eyewiki.aao.org/Corneal_Collagen_Cross-Linking. Accessed September 11, 2019.

Asri D, Touboul D, Fournie P, et al. Corneal collagen crosslinking in progressive keratoconus: multicenter results from the French National Reference Center for Keratoconus. J Cataract Refract Surg. 2011;37(12):2137-2143.

Avedro Inc. Photorexa® Viscous and Photorexa® Prescribing Label. 07/2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203324s000lbl.pdf. Accessed September 11, 2019.

Awdeh RM, Abbey AM, Vroman DT, et al. Phototherapeutic keratectomy for the treatment of subepithelial fibrosis and anterior corneal scarring after descemet stripping automated endothelial keratoplasty. Cornea. 2012;31(7):761-3.

Badawi AE. Accelerated corneal collagen cross-linking in pediatric keratoconus: One year study. Saudi J Ophthalmol. 2017;31(1):11-18.

Brooks NO, Greenstein S, Fry K, et al. Patient subjective visual function after corneal collagen crosslinking for keratoconus and corneal ectasia. J Cataract Refract Surg. 2012;38(4):615-619.

Caporossi A, Mazzotta C, Baiocchi S, et al. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010;149(4):585-593.

Caporossi A, Mazzotta C, Baiocchi S, et al. Riboflavin-UVA-induced corneal collagen cross-linking in pediatric patients. Cornea. 2012;31(3):227-231.

Center for Drug Evaluation and Research: FDA. Summary Review: Application Number 203324Orig2s000. July 15, 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203324Orig2s000SumR.pdf. Accessed September 11, 2019.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 80.7: Refractive keratoplasty. [CMS Web site]. 05/01/97. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=72&ncdver=1&bc=BAABAAAAAAAA&. Accessed September 11, 2019.

Centers for Medicare and Medicaid (CMS), Novitas, Inc. Medicare Services. Local Coverage Determination (LCD).L35094. Services that are Not Reasonable and Necessary. {Novitas Inc. Medicare Services Web site]. Original: 10/01/2015. (Revised: 07/01/2019). Available at:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=35094&ver=213&Date=09%2f11%2f2019&SearchType=Advanced&DocID=l35094&bc=KAAAABgAAAAA&. Accessed September 11, 2019.

Chan CC, LoVerde L, Qiang J, et al. Incidence, Risk Factors, and Surgical Management of Boston Type 1 Keratoprothesis Corneal Melts, Leaks, and Extrusions. Cornea. 2016;35(8):1049-1056.

Chunyu T, Xiujun P, Zhengjun F, et al. Corneal collagen cross-linking in keratoconus: a systematic review and meta-analysis. Sci Rep. 2014;4:5652.

Ciolino JB, Belin MW, Todani A, et al. Retention of the Boston keratoprosthesis type 1: multicenter study results. Ophthalmology. Jun 2013;120(6):1195-1200.

Crawford GJ, Hicks CR, Lou X, et al. The Chirila Keratoprosthesis: phase I human clinical trial. Ophthalmology. 2002;109(5):883-889.

Davis LJ, Schechtman KB, Wilson BS, et al. Longitudinal changes in visual acuity in keratoconus. Invest Ophthalmol Vis Sci. 2006;47(2):489-500.

De La Paz MF, De Toledo JA, Charoenrook V, et al. Impact of clinical factors on the long-term functional and anatomic outcomes of osteo-odonto-keratoprosthesis and tibial bone keratoprosthesis. Am J Ophthalmol. 2011;151(5):829-839.

Dunlap K, Chak G, Aquavella JV, et al. Short-term visual outcomes of Boston type 1 keratoprosthesis implantation. Ophthalmology. 2010;117(4):687-692.

Falcinelli G, Falsini B, Taloni M, et al. Modified osteo-odonto-keratoprosthesis for treatment of corneal blindness: long-term anatomical and functional outcomes in 181 cases. Arch Ophthalmol. 2005;123(10):1319-1329.

Gkika M, Labiris G, Kozobolis V. Corneal collagen cross-linking using riboflavin and ultraviolet-A irradiation: a review of clinical and experimental studies. Int Ophthalmol. 2011;31(4):309-319.

Gokhale NS. Corneal endothelial damage after collagen cross-linking treatment. Cornea. 2011;30(12):1495-1498.

Goldman DR, Hubschman JP, Aldave AJ, et al. Postoperative posterior segment complications in eyes treated with the Boston type I keratoprosthesis. Retina. 2013;33(3):532-541.

Hersh PS, Greenstein SA, Fry KL. Corneal collagen crosslinking for keratoconus and corneal ectasia: One year results. J Cataract Refract Surg. 2011;37(1):149-160.

Hersh PS, Stulting RD, Muller D, et al. United States multicenter clinical trial of corneal collagen crosslinking for keratoconus treatment. Ophthalmology. 2017;124(9):1259-1270.

Hersh PS, Stulting RD, Muller D, et al. U.S. multicenter clinical trial of corneal collagen crosslinking for treatment of corneal ectasia after refractive surgery. Ophthalmology. 2017;124(10):1475-1484.

Hicks CR, Crawford GJ, Lou X, et al. Corneal replacement using a synthetic hydrogel cornea, AlphaCor: device, preliminary outcomes and complications. Eye (Lond). 2003;17(3):385-392.

Hoffart L, Carles G, Matonti F. Lamellar corneal lenticule graft to treat keratolysis after AlphaCor keratoprosthesis implantation. Eur J Ophthalmol. 2015;25(1):1-7.

Hughes EH, Mokete B, Ainsworth G, et al. Vitreoretinal complications of osteoodontokeratoprosthesis surgery. Retina. 2008;28(8):1138-1145.

Jiraskova N., Roszival P., & Burova M., et al. AlphaCor artificial cornea: clinical outcome. Eye (Lond). 2011;25(9):1138-46.

Knutsson KA, Paganoni G, Matuska S, et al. Corneal collagen cross-linking in paediatric patients affected by keratoconus. Br J Ophthalmol. 2018;102(2):248-252.

Ladas JG. Highlights of the American Society of Cataract and Refractive Surgery (ASCRS)/American Society of Ophthalmic Administrators (ASOA) 2004 Symposium and Congress. [Medscape Web site]. 05/20/04. Available at: http://www.medscape.com/viewarticle/477705_print. Accessed September 11, 2019.

Lee WB, Shtein RM, Kaufman SC, et al. Boston Keratoprosthesis: outcomes and complications: a report by the American Academy of Ophthalmology. Ophthalmology. 2015;122(7):1504-1511.

Liu C, Okera S, Tandon R, et al. Visual rehabilitation in end-stage inflammatory ocular surface disease with the osteo-odonto-keratoprosthesis: results from the UK. Br J Ophthalmol. 2008;92(9):1211-1217.

McAnena L, Doyle F, O'Keefe M. Cross-linking in children with keratoconus: a systematic review and meta-analysis. Acta Ophthalmol. 2017;95(3):229-239.

McMahon TT, Edrington TB, Szczotka-Flynn L, et al. Longitudinal changes in corneal curvature in keratoconus. Cornea. 2006;25(3):296-305.

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Meiri Z, Keren S, Rosenblatt A, et al. Efficacy of corneal collagen cross-linking for the treatment of keratoconus: a systematic review and meta-analysis. Cornea. 2016;35(3):417-428.

Michael R, Charoenrook V, de la Paz MF, et al. Long-term functional and anatomical results of osteo- and osteoodonto-keratoprosthesis. Graefes Arch Clin Exp Ophthalmol. 2008;246(8):1133-1137.

National Institute for Health and Care Excellence (NICE). Photochemical corneal collagen cross-linkage using riboflavin and ultraviolet A for keratoconus and keratectasia [IPG466]. 2013. Available at: https://www.nice.org.uk/guidance/ipg466. Accessed September 11, 2019.

Odorcic S, Haas W, Gilmore MS, et al. Fungal infections after Boston Type 1 Keratoprosthesis Implantation: literature review and in vitro antifungal activity of hypochlorous acid. Cornea.2015;34(12):1599-1605.

Padmanabhan P, Rachapalle Reddi S, Rajagopal R, et al. Corneal collagen cross-linking for keratoconus in pediatric patients-long-term results. Cornea. 2017;36(2):138–143.

Papaioannou L, Miligkos M, Papathanassiou M. Corneal Collagen Cross-Linking for Infectious Keratitis: A Systematic Review and Meta-Analysis. Cornea. 2016;35(1):62-71.

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Raiskup-Wolf F, Hoyer A, Spoerl E, et al. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008;34(5):796-801.

Renesto Ada C, Barros Jde N, Campos M. Impression cytologic analysis after corneal collagen cross linking using riboflavin and ultraviolet-A light in the treatment of keratoconus. Cornea. 2010;29(10):1139-1144.

Rudnisky CJ, Belin MW, Guo R, et al. Visual acuity outcomes of the Boston Keratoprosthesis Type 1: multicenter study results. Am J Ophthalmol. 2016;162:89-98 e81.

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Srikumaran D, Munoz B, Aldave AJ, et al. Long-term outcomes of boston type 1 keratoprosthesis implantation: a retrospective multicenter cohort. Ophthalmology. 2014;121(11):2159-2164.

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Toprak I, Yaylali V, Yildirim C. Visual, topographic, and pachymetric effects of pediatric corneal collagen cross-linking. J Pediatr Ophthalmol Strabismus. 2017;54(2):84-89.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

65770


NOT COVERED

65760, 65765, 65767, 65771


EXPERIMENTAL/INVESTIGATIONAL

0402T


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy


HCPCS Level II Code Number(s)



MEDICALLY NECESSARY

C1818 Integrated keratoprosthesis

L8609 Artificial cornea

S0812 Phototherapeutic keratectomy (PTK)


NOT COVERED

S0800 Laser in situ keratomileusis (LASIK)

S0810 Photorefractive keratectomy (PRK)


Revenue Code Number(s)

0276 Medical/Surgical Supplies and Devices- Intraocular Lens

Coding and Billing Requirements






Policy History

Revisions for MA11.008d
11/18/2019Policy language addressing radial keratotomy and keratoplasty was revised for clarity. However, there was no change in coverage position.

Revisions for MA11.008c
07/01/2019This policy has been identified for the CPT code update, effective 07/01/2019.

The following CPT narrative has been revised in this policy: 0402T

Revisions for MA11.008b
03/28/2018This policy has undergone a routine review, and no revisions have been made.
08/02/2017The intent of this policy remains unchanged.

The following CPT code has been added to this policy:
65770

The following HCPCS codes have been added to this policy:
C1818, L8609

The following revenue code has been added to this policy:
0276

Revisions for MA11.008a
01/01/2017This version of the policy will become effective 01/01/2017. Collagen cross-linking of the cornea for the treatment of keratoconus, and Keratoprostheses implantation in the treatment of individuals with corneal opacities have been added to the policy.

Procedure code 0402T with an existing and continued experimental/investigational position has been added to the policy.

Revisions for MA11.008
03/02/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Refractive Keratoplasty.
12/31/2015This policy has been reissued in accordance with the Company’s annual review process.
01/01/2015This is a new policy.






Version Effective Date: 11/18/2019
Version Issued Date: 11/18/2019
Version Reissued Date: N/A