Refractive Surgery Applications, Guidelines and Consent Forms

 

GUIDE TO OMIC REFRACTIVE SURGERY REQUIREMENTS*

 

OMIC believes that prudent refractive surgery underwriting requirements help protect both the company and its insureds. These requirements, based on sensible medical practice and sound risk management principles, were developed by practicing refractive surgeons to reduce the likelihood of claims and to aid in the defensibility of any resulting claims. OMIC is proud that its claims experience is significantly better than industry average, and we believe this is due in large part to the company's underwriting requirements.

OMIC routinely reviews its refractive surgery requirements and modifies them when warranted. To date, all revisions have served to expand, rather than reduce or restrict, coverage.

ALL PROCEDURES
  • Prior to surgery, surgeon must perform and document an independent evaluation of the patient's eligibility for surgery, including performing slit lamp exam and reviewing topography, pachymetry, pupil size, and discuss monovision option for presbyopic patients
  • Patient age: at least 18 years old, stable refraction without contact lenses (off-label for Summit patients <21) for RK/AK, PRK, LASEK, LASIK, Intralase, Custom-Contoured Ablation, and Intacs; over 40 years old, stable refraction without contact lenses for LTK and CK
  • Operating surgeon must conduct informed consent discussion
  • Surgeon must document in medical record that risks, benefits, alternatives, and complications were discussed
  • Each patient must receive a copy of the consent form prior to the day of surgery
  • Surgeon or a designated ophthalmologist must perform the first postoperative visit
  • Advertisements (print, audio, video, Internet) must not be misleading or guarantee results
  • Surgeon must follow FDA and FTC advertising guidelines
LASIK/PRK/LASEK/IntraLASIK/Custom-CAP and other accepted variations
  • Surgeon must be certified on laser to be used
  • Surgeon must be appropriately trained on the microkeratome (if applicable)
  • Criteria for degree of myopia, hyperopia, and astigmatism must fall within FDA-approved guidelines. Off-label treatment of up to 6.0D astigmatism, -15.0D myopia, and +6.0D hyperopia permitted subject to special consent language.
  • Bilateral simultaneous requires previous unilateral experience (10 cases) + special OMIC consent form. No off-label use permitted for bilateral simultaneous PRK
  • Retreatment permitted after documented refractive stability
Radial and Astigmatic Keratotomy
  • Astigmatism: AK alone 1.0 D to 4D (demonstrate over-correction if <1.5 D), AK with RK up to 6D (otherwise demonstrate residual to patient)
  • Myopia: -1D to -8D (demonstrate residual if more than 6D)
  • Bilateral simultaneous not covered for primary surgery
  • Minimum of one week between primary procedure on first and second eye and between primary procedure and enhancement on same eye
Intrastromal Corneal Ring Segments ("Intacs")
  • Astigmatism: 1.0D ; Myopia: -1D to -3D
  • Bilateral simultaneous requires previous unilateral Intacs experience (10 cases), special OMIC consent form
  • Use for treatment of keratoconus permitted subject to underwriting review and special patient selection criteria
Laser Thermal Keratoplasty (LTK) and Conductive Keratoplasty (CK)
  • Astigmatism: 0.75D ; Hyperopia: 0.75D to 2.50D (LTK)/0.75D to 3.0D (CK)
  • Presbyopia (CK only): 0.75D astigmatism, emmetropia or mild hyperopia; spherical hyperopic treatment of 1 to 2.25D; successful trial or history of monovision; special requirements for treatment of dominant eye
  • Bilateral simultaneous requires special OMIC consent form
Refractive Lens Exchange
  • Myopia: -6 D to -15 D. Patients must be age 40+ and presbyopic.
  • Hyperopia: Axial length 20 mm or longer. UCVA 20/40 or worse. +1 D to +15 D if age 40+ and presbyopic. +4 D to +15 D if under age 40.
  • Coverage not available for treatment of emmetropic patients (with or without presbyopia).
  • Patients must undergo complete retinal exam and be advised of increased risk of retinal detachment.
  • Minimum interval of one week between primary procedures.
Phakic Implants for Refractive Purposes
  • For FDA approved implants, criteria for degree of myopia and astigmatism and for anterior chamber depth must fall within FDA approved guidelines
  • For cases performed during course of clinical trials, patients must fall within patient selection criteria established by trial protocol
  • Minimum interval of one week between primary procedures

*This abbreviated list is provided as a quick reference for OMIC insureds and is not a complete list of underwriting requirements or refractive procedures covered. Coverage for refractive surgery is not automatic and must be specifically applied for. Call OMIC's Underwriting Department at 1-800-562-6642, send us an email at underwriting@omic.com, or access our web site at www.omic.com for clarification or more detailed information.

07/05