Multifocal IOL Issues 030906 by f1hQ3qCm


                                 Ophthalmic Mutual Insurance Company
                                                 (a Risk Retention Group)

             Multifocal IOLs and Other Alternatives for Near Vision
              After Cataract or Refractive Lens Exchange Surgery
                                            Anne M. Menke, R.N., Ph.D.
                                              OMIC Risk Manager

DISCLAIMER: Recommendations presented here should not be considered inclusive of all proper methods of care or
exclusive of other methods of care reasonably directed to obtain the same results. The ultimate judgment regarding the
propriety of any specific procedure or treatment must be made by the ophthalmologist in light of the individual
circumstances presented by the patient.

This information is intended solely to provide risk management recommendations. It is not intended to constitute legal
advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be

This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please
refer to your OMIC policy for these terms and conditions.

A number of intraocular lenses with the potential to provide distance vision AND restore some or all
of the focusing (accommodating) ability of the eye have been approved by the Food and Drug
Administration (FDA), providing ophthalmologists and their patients with more choices for both
cataract and refractive surgery. Depending upon the technological features of the IOLs, they may be
described as “accommodating,” “apodized diffractive,” or “presbyopia-correcting.” All of these lens
are “multifocal,” meaning they correct for both distance vision and other ranges, such as near or
intermediate. These new alternatives for near vision after cataract or refractive lens exchange (RLE)
surgery raise coverage and consent issues. These risk management recommendations are
intended to promote patient safety and reduce the physician’s liability exposure when
performing cataract or RLE surgery.

OMIC Coverage/Underwriting Issues
 Ophthalmologist decides what lens to use
 Cataract surgery: no Underwriting requirements or rules
 Refractive Lens Exchange (RLE):
     o If cataracts are not visually significant or not present, considered to be refractive lens
          exchange, subject to refractive surgery requirements
     o Coverage for all refractive surgery is excluded under the policy; coverage for RLE is
          available if approved and endorsement issued.
               Contact the Underwriting Department at (800) 562-6642, extension 639 to verify
                  coverage or request an application.
     o Degree of myopia and hyperopia must fall within OMIC RLE requirements
               HYPEROPIA
                        Minimum 20 mm axial length
                        UCVA 20/40 or worse
                        If over 40 years of age: Minimum +1.00, maximum +15.00 diopters AND
                      Under age 40: Minimum + 4.0, maximum + 15.00 diopters
              MYOPIA
                      Presbyopic and over 40 years old
                      Minimum -6.00, maximum -15.00 diopters
                      No coverage for RLE
       o All RLE patients must undergo a complete retina examination pre- and postoperatively.
         The retinal examination may be conducted by the surgeon, a retina specialist, or other
         qualified ophthalmologist.
       o Patients must be advised of the increased risk of retinal detachment.
       o Minimum interval of one week between primary procedures

General Consent Issues Related to Cataract or RLE Surgery
 Clinical issues
      o Hyperopia:
                Explain risk of retinal detachment
                Explain risk of nanophthalmic choroidal effusion in high hyperopes or those with
                   short axial length
      o Myopia
                Explain risk of retinal detachment in high myopes or those with long axial length
 Explain FDA Status of IOL
      o Explain when lens approved and its purpose
                If recently approved, explain lack of information about long-term outcomes and
                   possibility that there may be unforeseen complications
      o If refractive lens exchange, advise of off-label use of implant and document discussion in
          medical record and consent form
 Discuss presbyopia and alternatives for near vision after cataract or RLE surgery with patients.
   They should not feel any pressure to choose more expensive options.
 Explain rationale for choice and information about the IOL
      o Explain labeling information a reasonable person would like to know, i.e., risks, benefits,
          alternatives of the lens in question
 Clarify that no guarantee can be made as to how effectively the patient will see after surgery
      o The selection of the proper lens implant, while based upon sophisticated equipment and
          computer formulas, is not an exact science. The results may differ from what was
          predicted or planned.
      o If the refractive result is considerably different than planned, then eyeglasses, refractive
          surgery, or repositioning or replacement of the lens itself may be needed
 Explain what will happen if lens cannot be placed due to problems arising during surgery

Consent Issues Associated With Specific Near-Vision Choice

      o Discuss and document less expensive option of treatment of eye for distance with
         continued use of reading glasses following surgery for near vision, or of treatment of eye
         for near with continued use of glasses for distance following surgery.
      o Discuss option of monovision with different-powered monofocal implants
      o Demonstrate monovision in the office with contact lenses or glasses
      o Determine which eye is the dominant eye
      o Explain that monovision may result in problems with impaired depth perception.
         Choosing the wrong eye for distance correction may result in feeling that things are the
         “wrong way around.” Once surgery is performed, it is not always possible to undo what is
         done, or to reverse the distance and near eye without some loss of visual quality.
      o Document that patient does not accept this alternative or declined demonstration
      o Explain that goal is to reduce dependency on glasses or contact lenses but that cannot
         guarantee outcome
      o Explain that multifocal IOL might result in less sharp vision, which may become worse in
         dim light or fog. It may also cause some visual side effects such as rings or circles around
         lights at night. It may be difficult to distinguish an object from a dark background, which
         will be more noticeable in areas with less light. Driving at night may be affected.
      o If the patient drives a considerable amount at night, or performs delicate, detailed, “up-
         close” work requiring closer focus than just reading, a monofocal lens in conjunction with
         eyeglasses may be a better choice.
      o If complications occur at the time of surgery, a monofocal IOL may need to be implanted
         instead of a multifocal IOL.
      o Discuss financial implications of multifocal IOL
              CATARACT SURGERY
              Medicare May 10, 2005, ruling on payment for “presbyopia-correcting” IOLs
                       Presbyopia-correcting IOL device and associated services for fitting one
                          lens are considered partially covered
                       The beneficiary is responsible for payment of that portion of the charge for
                          the presbyopia-correcting IOL and associated services that exceed the
                          charge for insertion of a conventional IOL following cataract surgery
              CMS Frequently Asked Questions (FAQ) for Presbyopia-Correcting IOLs were
                  posted on March 8, 2006
                       No waiver is required. The physician may give the patient a Notice of
                          Exclusion from Medicare Benefits (NEMB) available at
                       Medicare will pay for one pair of eyeglasses or contact lens following
                          cataract surgery with the insertion of an IOL.
                       Providing inducements like free transportation or free services is forbidden
                          by Medicare. Rules prohibit providing inducements to beneficiaries to
                          encourage them to use services.

                            If a benificiary’s presbyopia-correcting IOL must be removed for some
                             medical reason, Medicare will cover the insertion of a conventional IOL as
                             a replacement for that lens.
                         The FAQs include answers to coding and billing questions as well.
                 Private insurance: Check with each plan about coverage, deductibles, and
                 RLE SURGERY
                 There is generally no insurance coverage for RLE surgery.
        o Emphasize that while goal is to restore some or all of the near (and intermediate,
            depending upon the lens) focusing ability of the eye, that other factors may affect the
            outcome, such as the lens implant power, the healing ability of the individual patient, and
            the function of the patient’s ciliary muscle
   Sample consent forms for cataract and RLE surgery are available in the “Informed Consent
    Documents” section of the OMIC website at

Advertising Issues
Allegations related to physician advertising are surfacing with increasing regularity in medical
malpractice claims. The first is lack of informed consent. Aggressive advertising can run the
risk of overstating the possible benefits of a procedure, and potentially mislead patients into
agreeing to undergo the surgery without fully understanding or appreciating the consequences
and alternatives. Unfortunately, stories of physician advertisements being introduced in court to
destroy the validity of a consent form are all too often true.

In addition to allegations of lack of informed consent, plaintiffs are also using state consumer
protection laws to claim that the physician defrauded the patient. State law may allow the
plaintiff to ask for punitive damages, which might double or treble the amount of money
awarded to the patient by the jury. Physicians should be particularly concerned about these
allegations since most professional liability insurance policies do not pay for such damages.

For more information, see “Advertising for Medical Services” and “Advertising Review Form,”
available in the “Risk Management Recommendations” section of the OMIC website at

OMIC policyholders with additional questions or concerns about multifocal IOLs are invited to
call Anne M. Menke, R.N., Ph.D., OMIC Risk Manager, at (800) 562-6642, extension 651.

                                                                                        Version 3/9/06


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