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| Medical Policy: | S-41-023 |
| Topic: | Corneal Surgery to Correct Refractive Errors and Phototherapeutic Keratectomy |
| Section: | Surgery |
| Effective Date: | June 25, 2018 |
| Issue Date: | June 25, 2018 |
| Last Reviewed: | June 2018 |
Corneal surgery is performed to change the shape of the cornea which will correct vision problems such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. Corneal surgeries performed for this purpose include radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in-situ keratomileusis (LASIK), keratomileusis, keratophakia, and epikeratoplasty. Phototherapeutic keratectomy (PTK) involves the use of the excimer laser to treat visual impairment or irritative symptoms relating to diseases of the anterior cornea. PTK functions by removing anterior stromal opacities or eliminating elevated cornea lesions while maintaining a smooth corneal surface. Intrastromal corneal ring segments (e.g., INTACS) consist of micro-thin methylmethacrylate inserts of variable thickness that are implanted on the perimeter of the cornea. They are used in refractive surgery to correct mild myopia (see above), and as a treatment of keratoconus. The inserts help restore vision in keratoconus patients by flattening and repositioning the cornea. |
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
| Policy Position Coverage is subject to the specific terms of the member’s benefit plan. |
Corneal refractive surgery may be considered medically necessary when ANY ONE of the following is met:
- Correction of astigmatism resulting from trauma or from a previous eligible surgery (e.g., cataract surgery); or
- Correction of aphakia.
For all other indications, corneal refractive surgery is considered not medically necessary.
NOTE: These procedures should not be confused with corneal transplants (also called keratoplasties). Refer to S-116 Corneal Transplants.
Corneal surgeries reported for correction of refractive purposes are not covered services and are non-covered.
PTK may be considered medically necessary for ANY ONE of the following conditions:
- Corneal scar and opacities (including post-traumatic, post-infectious, post-surgical, and secondary to pathology); or
- Superficial corneal dystrophy (including granular, lattice and Reis-Bückler’s dystrophy); or
- Epithelial membrane dystrophy; or
- Irregular corneal surfaces due to Salzmann’s nodular degeneration or keratoconus nodule; or
- 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.
NOTE: PTK should not be confused with photorefractive keratectomy (PRK). Although technically the same procedure, PTK is used for the correction of particular corneal diseases whereas PRK involves the use of the excimer laser for correction of refractive errors (e.g., myopia, hyperopia, astigmatism, and presbyopia) in persons with otherwise non-diseased corneas.
For all other indications, PTK is considered not medically necessary.
Insertion of intrastromal corneal ring segments (e.g., INTACS) may be considered medically necessary when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the U.S. Food and Drug Administration (FDA) for the treatment of patients with keratoconus who meet ALL of the following criteria:
- Who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; and
- Who are 21 years of age or older; and
- Who have clear central corneas; and
- Who have a corneal thickness of 450 microns or greater at the proposed incision site; and
- Who have corneal transplantation as the only option remaining to improve their functional vision.
For all other indications, implantation of intrastromal corneal ring segments is considered not medically necessary.
Any pre- and post-operative evaluations and measurements [e.g., ophthalmic echography, keratometry, pachymetry, etc.] performed in conjunction with services identified within this policy as not medically necessary are non-covered.
Contact lenses are covered for the treatment of keratoconus.
Any pre- and post-operative evaluations and measurements [e.g., ophthalmic echography, keratometry, pachymetry, etc.] performed in conjunction with ineligible procedures are non-covered.
Refer to medical policy S-116, Corneal Transplantation, for additional information. |
| Place of Service: Outpatient |
Corneal surgery to correct refractive errors and phototherapeutic keratectomy is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
| The policy position applies to all commercial lines of business |
| Denial Statements |
Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
A network provider can bill the member for the non-covered service.
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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
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U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
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