Subject:
Refractive Keratoplasty Procedures
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Refractive keratoplasty is a generic term which includes all surgical procedures to reshape the cornea of the eye to correct vision problems such as myopia (nearsightedness), hyperopia (farsightedness) and astigmatism. Refractive keratoplasties include the following procedures:
- Radial Keratotomy (RK) is a surgical correction for myopia. Using a high-powered microscope, the surgeon 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.
- Astigmatic Keratotomy (AK) is a similar technique to RK used to reduce astigmatism. Incisions are in a curved rather than a radial pattern. AK can be combined with RK to reduce myopia with astigmatism.
- Photorefractive Keratectomy (PRK or often referred to as Excimer Laser Surgery) uses a computerized laser to correct myopia as well as astigmatism. 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) is a procedure used to reduce high levels of myopia, usually above five to six diopters, and hyperopia. It is done as an outpatient procedure under topical anesthesia and usually takes less than one hour. Normally, one eye is treated at a time, with about 3 to 4 weeks allowed between each eye surgery. In ALK for myopia, the surgeon creates a flap by slicing across the front of the cornea with an instrument called a microkeratome. After folding the flap to the side, the surgeon uses the microkeratome to remove a thin disc of tissue from the exposed surface of the cornea. The front flap is then replaced without the need for sutures. By removing this thin layer of tissue, the central optical zone is flattened, reducing myopia. In ALK for hyperopia, the surgeon slices the cornea at a deeper level with the microkeratome. The internal pressure of the eye stretches the remaining thin corneal surface, causing it to bulge forward. The surface flap is then replaced without removing any corneal tissue. Because the cornea is bulging slightly, it is steeper and provides extra optical power for hyperopic correction. As with ALK for myopia, no stitches are used in this procedure.
- Laser-Assisted In-Situ Keratomileusis (LASIK) is a procedure that combines two previously described refractive procedures; Lamellar Keratoplasty and Photorefractive Keratotomy, and is used to correct refractive errors. In LASIK, a corneal flap is created by using the microkeratome while the excimer laser is used to remove a thin layer of tissue from the center of the cornea.
- Laser-Assisted Subepithelial Keratectomy (LASEK) is a procedure that uses an alcohol solution to loosen and peel back the epithelium to expose the cornea. The excimer laser then re-sculpts the cornea, and the epithelium is placed back in position.
- Epi-LASIK is a refractive surgery procedure used for patients with thin corneas who would not otherwise be candidates for the conventional LASIK procedure. It uses an epi-keratome which precisely separates the thin epithelial sheet from the rest of the cornea and is lifted to one side. A laser is used to treat the cornea and the epithelial sheet is moved back into place where it will self-adhere.
- 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 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.
- Lensectomy (refractive lensectomy, clear lensectomy) involves the use of cataract surgical technology to correct refractive errors in the absence of a cataract. In refractive lensectomy, the lens material of the eye is removed in the same way as a cataract. An intraocular lens of appropriate power is inserted, thus correcting myopia or hyperopia. Since the lens implant is a fixed focus lens, glasses may be necessary for all near vision activities such as reading. This procedure is most commonly performed on patients with extreme hyperopia who are unable to be corrected with excimer laser or LASIK, or those who are over 60 years of age who are at risk of cataract formation. Lensectomy can be combined with the Staar toric intraocular lens or astigmatic keratotomy to correct the remaining astigmatism component.
All of the above procedures are 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.
Policy:
[INFORMATIONAL NOTE: This policy does not address corneal transplants (also called keratoplasties) and keratoprosthesis.
NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Refractive keratoplasty procedures are generally considered cosmetic procedures and therefore, not medically necessary, when performed to correct disorders of refraction or accommodation (e.g., myopia, hyperopia, astigmatism) as substitute to eye glasses or contact lenses.
2. When there is documentation of a clinical condition that precludes reasonable correction of vision with use of eyeglasses or contact lenses (or other refractive surgical procedures - specifically for lensectomy), refractive keratoplasty procedures will be considered medically necessary.
3. Certain refractive keratoplasty procedures (i.e., PRK, keratomileusis, keratophakia, or epikeratoplasty) will be considered medically necessary when performed to treat the following conditions:
- keratoconus
- corneal opacities and scarring
- aphakia (congenital or traumatic)
4. The correction of astigmatism resulting from trauma or from previous covered surgery (e.g., cataract) is considered medically necessary.
(NOTE: CPT codes 65772 and 65775 are specific for this purpose.)
5. Refractive keratoplasty procedures are NOT considered medically necessary when required for occupational reasons to correct vision (e.g., airline pilot, firefighter) and the member's condition does not meet the requirements set forth in policy statements 2, 3 or 4.
Medicare Coverage:
Medicare Advantage Products differ from the Horizon BCBSNJ Medical Policy. Per National Coverage Determination (NCD) 80.7 Refractive Keratoplasty, CMS has determined that the correction of common refractive errors by eyeglasses, contact lenses or other prosthetic devices is specifically excluded from coverage. The use of radial keratotomy and/or keratoplasty for the purpose of refractive error compensation is considered a substitute or alternative to eye glasses or contact lenses, which are specifically excluded by §1862(a)(7) of the Act (except in certain cases in connection with cataract surgery). In addition, many in the medical community consider such procedures cosmetic surgery, which is excluded by section §1862(a)(10) of the Act. Therefore, radial keratotomy and keratoplasty to treat refractive defects are not covered.
Keratoplasty that treats specific lesions of the cornea, such as phototherapeutic keratectomy that removes scar tissue from the visual field, deals with an abnormality of the eye and is not cosmetic surgery. Such cases may be covered under §1862(a)(1)(A) of the Act.
For additional information about eligibility and coverage, refer to NCD 80.7. Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Refractive Keratoplasty Procedures
Astigmatic Keratotomy
Automated Lamellar Keratoplasty
Clear Lensectomy
Epi-LASIK
Epikeratophakia
Excimer Laser Surgery
Hexagonal Keratotomy
Keratectomy, Photorefractive
Keratomileusis
Keratophakia
Keratoplasty, Lamellar
Keratoplasty Procedures, Refractive
Keratotomy
Lamellar Keratoplasty
Laser-Assisted In-Situ Keratomileusis
Laser-Assisted Subepithelial Keratectomy
Laser Surgery, Excimer
LASEK
LASIK
Lensectomy
Minimally Invasive Radial Keratotomy
Photorefractive Keratectomy
PRK
Radial Keratotomy
Refractive Lensectomy
References:
1. Fink AM, Gore C, Rosen ES. Refractive lensectomy for hyperopia. Ophthalmology. 2000 August;107(8):1540-1548.
2. Siganos DS, Pallikaris IG. Clear lensectomy and intraocular lens implantation for hyperopia from +7 to +14 diopters. J Refract Surg. 1998 Mar-Apr;14(2):105-113.
3. Lindstrom RL, Hardten DR, Chu YR. Laser In Situ keratomileusis (LASIK) for the treatment of low moderate, and high myopia. Trans Am Ophthalmol Soc. 1997;95:285-296.
4. Minnesota Health Technology Advisory Committee (HTAC). Refractive Eye Surgery for Myopia. June 1999.
5. American Academy of Ophthalmology <www.eyenet.org>
6. American Society of Ophthalmic Administrators <www.ascrs.org>
7. International Society of Refractive Surgery <www.isrs.org>
8. Bower KS, Weichel ED, Kim TJ. Overview of refractive surgery. Am Fam Physician 2001 Oct;64(7):1183-1190.
9. Sher NA. Hyperopic refractive surgery. Curr Opin Ophthalmol 2001 Aug;12(4):304-308.\
10. Ge J, Arellano A, Salz J. Surgical correction of hyperopia: clear lens extraction and laser correction. Ophthalmol Clin North Am 2001 Jun;14(2):301-313, viii.
11. Duffey RJ, Leaming D. U.S. trends in refractive surgery: 2001 International Society of Refractive Surgery Survey. J Refract Surg 2002 Mar-Apr;18(2):185-188.
12. Corneal surgery for correction of refractive errors. Med Lett Drugs Ther 1999 Dec 17;41(1068):122-123.
13. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Refractive Keratoplasty (80.7), Effective 5/1/1997. [Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=72&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=New+Jersey&KeyWord=keratoplasty&KeyWordLookUp=Title&KeyWordSearchType=And&ncd_id=80.7&ncd_version=1&basket=ncd%253A80%252E7%253A1%253ARefractive+Keratoplasty&bc=gAAAABAAAAAAAA%3d%3d&.
14. Rufer F, Schroder A, Bader C, Erb C. Age-related changes in central and peripheral corneal thickness: determination of normal values with the Orbscan II topography system. Cornea 2007 Jan;26(1):1-5.
15. Food and Drug Administration. FDA Consumer Magazine. A Focus on Vision. July-August 2006.
[Available at: http://www.fda.gov/fdac/features/2006/406_vision.html.]
16. UpToDate. Laser refractive surgery. Literature review current through August 2016. Topic last updated April 27, 2016.
17. Bower KS. Laser refractive surgery. In: UpToDate, Trobe J, Libman H (Eds), UpToDate, Waltham, MA. (Accessed July 5, 2017.)
18. Bower KS. Laser refractive surgery. In: UpToDate, Trobe J (Eds), UpToDate, Waltham, MA. (Accessed July 2, 2018.)
19. Bower KS. Laser refractive surgery. In: UpToDate, Trobe J, Givens J (Eds), UpToDate, Waltham, MA. (Accessed June 20, 2019)
20. Bower KS. Laser refractive surgery. In: UpToDate, Jacobs DS, Givens J (Eds), UpToDate, Waltham, MA. (Accessed July 1, 2020)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
65760
65765
65767
65771
65772
65775
66999
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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