Intacs™ by Keravision® for Myopia
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Version 12/01/02
INFORMED CONSENT FOR KERAVISION® INTACS™
The following information is being provided so that I can make an informed decision about having KeraVision Intacs to correct my nearsightedness (myopia). I may take as much time as I need to read, fully understand, and ask any questions I may have before signing this consent form.
Introduction
This information is to help you make an informed decision about having KeraVision Intacs to correct your nearsightedness (myopia). Every surgery has risks as well as benefits and each person must evaluate this risk/benefit ratio for himself/herself based on the patient information given to you as well as the conversation with your physician and staff. You are encouraged to ask any questions and have them answered to your satisfaction before you give your permission for surgery.
Expected Benefits:
KeraVision Intacs may correct nearsightedness between -1.00 and -3.00 diopters with 1.00 diopter or less of astigmatism.
KeraVision Intacs may reduce overall nearsightedness while also reducing or eliminating dependency upon eyeglasses.
KeraVision Intacs corrects nearsightedness without permanently altering the central part of the cornea which is critical for clear vision.
KeraVision Intacs can be removed and replaced, if desired.
Possible Risks:
As with any refractive surgery procedure, there are certain risks and complications you need to be aware of when considering KeraVision Intacs.
If the results of KeraVision Intacs are not satisfactory or sufficiently effective, you may need to have an additional procedure to replace your KeraVision Intacs or to have them removed.
You may have discomfort and/or pain for up to 48 hours following the procedure. Your doctor may recommend a medication to help ease your discomfort.
You may have blurred vision, fluctuating vision and tearing following the procedure.
You may be sensitive to bright light or glare following the procedure.
You may experience astigmatism (a temporary blurring or distortion of your vision) for several days after the procedure. This type of visual distortion is normal during the healing process and, in most cases, it decreases overtime. However, in rare instances, it may be permanent.
Infection is a risk with any surgical procedure.
Certain patients have reported continued visual distortion related to KeraVision Intacs.
The US Studies showed that the following potential vision-threatening events happened less than 1% of the time after KeraVision Intacs. All patients returned to the vision they had prior to the procedure.
-Infection (0.2%)
-Stromal thinning due to shallow placement (0.2%)
There are risks associated with any surgery. Since it is impossible to state every risk or complication that may occur as a result of any surgery, the possible risks and complications listed in this informed consent may be incomplete. There may be risks or complications associated with this surgery that are unknown because this is a relatively new procedure.
By signing this form I acknowledge that I understand the following:
The procedure to be performed on my eye consists of inserting two small transparent half rings into the peripheral cornea through a tiny incision. KeraVision Intacs are designed to remain permanently in the eye, yet they can also be removed and replaced, if desired.
KeraVision Intacs is purely an elective procedure.
The alternatives to KeraVision Intacs for correcting nearsightedness include eyeglasses, contact lenses, and other kinds of refractive surgery procedures such as Radial Keratotomy (RK), Photorefractive Keratectomy (PRK) and Laser in situ keratomileusis (LASIK).
KeraVision Intacs will not prevent the development of naturally occurring eye problems such as glaucoma, cataracts, retinal degeneration or detachment. KeraVision Intacs do not correct the condition known as presbyopia (or aging of the eye) which may require reading glasses for close-up work.
I understand that having KeraVision Intacs does not necessarily mean total freedom from eyeglasses because excellent vision without eyeglasses cannot be guaranteed.
It has been brought to my attention that KeraVision Intacs are not risk-free. The complications that may occur include improper correction, decrease in best-corrected visual acuity, fluctuating vision, glare, halo, corneal edema, corneal perforation and infection. There is a possibility of other complications due to anesthetic drops, eye drop reaction or other factors.
I understand that there are risks associated with any surgery including this procedure. There may be risks and complications associated with this surgery that are unknown because this is a relatively new procedure.
I understand that there is a possibility that my surgeon may not be able to insert INTACS into my cornea and that the surgery may have to be cancelled.
Please initial after reading this page
In signing this form, I am stating that I have read this consent (or it has been read to me) and understand the complications. I have had the opportunity to ask questions and have had them answered to my satisfaction. It is understood that further procedures may be required to reach the desired result. However, there is no guarantee with an additional procedure the desired change in refractive error can be obtained, though there could be significant improvement in uncorrected vision.
I authorize the sharing of my relevant medical information among doctors regarding my pre- and post- operative care.
I have arranged for transportation after the procedure and to my next appointment. I understand that my doctor will advise me when I can safely resume driving.
I accept full personal financial responsibility for payment of all fees related to my KeraVision Intacs. These include the procedure itself, possibly necessary medications, eyeglasses required after the procedure, and expenses connected with my travel to and from the surgery site or office.
I understand and am acknowledging my willingness to follow the doctors instructions and attend regular postoperative visits to reduce the risk of long-term complications.
Although it is impossible to be informed regarding every possible complication that may occur, all my questions have been answered to my satisfaction. The decision to undergo KeraVision Intacs has been my own and been made without duress of any kind. I understand that I will receive a copy of this form, if requested.
I have been given a copy of the Patient Booklet, entitled “Facts You Need to Know About KERAVISION ® INTACS™ for Nearsightedness” and have discussed it with my doctor.
I give permission for my doctor to:
Record on video or photographic equipment my procedure for purposes of education, research or the training of other health care professionals.
Use the data about my procedure in subsequent procedures without reference to my name, to further the understanding of refractive surgery.
Allow observers during this procedure for educational, medical and scientific purposes.
I understand that my permission is voluntary that I may refuse to participate or may withdraw consent or discontinue participation at any time, without prejudice to my present or future care.
I am making an informed decision in giving my permission to have KeraVision Intacs performed on my
right eye left eye
All of my questions have been answered to my satisfaction.
Patient Signature Date Patient’s Printed Name
Conductive Keratoplasty. Bilateral Simultaneous CK for Hyeropia
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Addendum: Consent for Bilateral Simultaneous CK for Treatment of Hyperopia
If you elect to have surgery performed on both eyes at the same time, you should understand both the possible advantages and disadvantages of your decision.
Safety: The risk of infection and other healing complications is applicable to both eyes simultaneously. Therefore, if an infection occurs in one eye, it may also occur in the other eye. Although rare, a serious infection in both eyes can cause significant loss of vision and even legal blindness. By choosing to have CK performed on separate days, you will avoid the risk of having one or more of these complications in both eyes at the same time.
Accuracy: If there is an over-correction or under-correction in one eye, chances are it may happen in both eyes. If a retreatment is required in one eye, it is quite possible that your fellow eye may also require a retreatment. By having surgery on separate days, the doctor can monitor the healing process and visual recovery in the first eye and may be able to make appropriate modifications to the treatment plan for the second eye if necessary. In some patients, this may improve the accuracy of the result in the second eye. By correcting both eyes simultaneously, there is no opportunity to learn from the healing patterns of the first eye before treating the second eye.
Visual Recovery: Some patients may experience symptoms such as blurred vision, night glare or ghost images that can delay recovery of normal vision. Blurred vision may continue for several weeks, which could make driving difficult or dangerous and could interfere with your ability to work if it occurs in both eyes. There is no way of predicting how long your eyes will take to heal.
If the eyes are operated separately, you can generally function with your fellow eye while the first eye is healing. However, there may be a period of imbalance in vision between your eyes, producing a form of double vision. If you are able to wear a contact lens in your unoperated eye, the corrective lens could minimize this imbalance. The balance in vision between your two eyes may be restored more rapidly if they are operated on the same day.
Satisfaction: Both eyes tend to experience similar side effects. If you experience undesirable side effects such as pain, glare, ghost images, increased light sensitivity, or corneal haze in one eye, you will likely experience them in both eyes. These side effects may cause a decrease in vision or other negative effects, and some patients have elected to not have their second eye treated. By having each eye treated on separate dates, you will have the opportunity to determine whether the CK procedure has produced satisfactory visual results without loss of vision or other undesirable side effects.
Convenience: It may be inconvenient for you to have each eye treated at separate visits because it would necessitate two periods of recovery from the laser surgery and might require additional time away from work.
Cost: Professional and facility fees may be greater if the eyes are operated on different days and the additional time off work can be costly.
____________
Initial
Consent Statement:
“I have read and understand the above risks and benefits of bilateral simultaneous CK for treatment of hyperopia, and I understand that this summary does not include every possible risk, benefit and complication that can result from bilateral simultaneous CK. My doctor has answered all of my questions about the CK procedure. I wish to have both of my eyes treated during the same treatment session if my doctor determines that the treatment in the first eye appeared to be technically satisfactory.”
The reason(s) I wish to have both eyes treated at the same time are:
Greater convenience
Possible faster recovery
Less time away from work
Contact lens intolerance and/or difficulty wearing contacts
Elimination of possible vision imbalance between treated and untreated eyes
Other
Patient signature Date
Witness Date
Conductive Keratoplasty NearVisionSM CK
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Version 06/30/05
INFORMED CONSENT FOR NEARVISIONSM CK® (CONDUCTIVE KERATOPLASTY®)
Introduction
Vision-correcting surgery such as Conductive Keratoplasty, LASIK and PRK can precisely and accurately correct fixed focal errors of the eye such as farsightedness, nearsightedness, and astigmatism. These optical conditions are fundamentally different than presbyopia, the loss of adjustability of focus for near viewing. Presbyopia is the reason that reading glasses become necessary, typically in the age range of mid-40, even for people who have excellent unaided distance vision. For those that require prescriptive correction to see clearly at distance, bifocals or separate (different prescription) reading glasses become necessary at that age to see clearly at close range.
This information and the Patient Information booklet are being provided to you so that you can make an informed decision about the use of a device known as the ViewPoint™ CK System, which is utilized to perform the NearVision CK procedure. NearVision CK is one of a number of alternatives for correcting your vision. The NearVision CK procedure uses a controlled release of radiofrequency (RF) energy to increase the temperature of corneal tissue. The treatment is applied with a probe that is introduced 16 to 24 times into the cornea in a circular pattern, which results in an increased curvature of the cornea to treat your vision. The correction you achieve with NearVision CK may be temporary.
NearVision CK is an elective procedure. There is no emergency condition or other reason that requires or demands that you have it performed. You could continue wearing contact lenses or glasses and have adequate visual acuity. This procedure, like all surgery, presents some risks, many of which are listed below. You should also understand that there might be other risks not known to your doctor, which may become known later. Despite the best of care, complications and side effects may occur; should this happen in your case, the result might be affected even to the extent of making your vision worse.
Alternatives to NearVision CK
There are several options available to those who are presbyopic, besides wearing bifocals or separate reading glasses. For example, for some individuals, wearing a contact lens in one eye for distance vision, and a contact lens in the other eye for reading, affords a reasonable solution. This is called monovision (mono for one; one eye for distance, one eye for near vision).
If a person enjoys and functions well with monovision in contact lenses, the same option can be created on a more permanent basis with vision-correcting surgery such as NearVision CK. If you are contemplating such correction for yourself, it is important to understand the advantages and drawbacks of such care.
If you decide not to have NearVision CK, alterative methods of correcting your vision include, among others, eyeglasses, contact lenses, and other refractive surgical procedures.
Patient Initials
NEARVISIONSM CK® INFORMED CONSENT
PAGE 2
Patient Consent
At this time, there is no perfect treatment or cure for presbyopia. The typical solutions described above are all to some extent a compromise of one form or another. For many people, wearing reading glasses for near vision correction is troublesome enough, and wearing bifocals is even less pleasant.
In giving my permission for NearVision CK, I understand the following: the long-term risks and effects of NEARVISION CK are unknown. I have received no guarantee as to the success of my particular case. I understand that the following risks are associated with the procedure:
Vision Threatening Complications
I understand that it is possible that scarring, ulceration, or an eye infection that could not be controlled with antibiotics or other means could also cause damage to my cornea.
Non-vision Threatening Side Effects
1) I understand that I may experience a reduction in my depth perception. For most people, depth perception is best when viewing with both eyes optimally corrected and “balanced” for near and distance. Eye care professionals refer to this as binocular vision. Monovision can impair depth perception to some extent, because the eyes are not focused together at the same distance. Because monovision can reduce optimum depth perception, it is important that you complete a successful trial of monovision or have a history of monovision wear using glasses or contact lens prior to contemplating a surgical correction.
2) I understand that ocular dominance and choosing the ‘near’ eye correctly is important when considering monovision. Tests can be performed to determine which eye, right or left, is dominant, or preferred eye for viewing, in a particular person. Conventional wisdom holds that if contemplating monovision, the non-dominant eye is corrected for near, and the dominant eye should be maintained or corrected for distance; the FDA approved CK for presbyopia under these conditions. While correcting the non-dominant eye for near is a guideline, it should not be construed as an absolute rule. A very small percentage of persons may be co-dominant (similar to being ambidextrous), and in rare circumstances a person may actually prefer using the dominant eye for near viewing. The methods for testing and determining ocular dominance are not always 100% accurate; there is some subjective component in the measurement process; and different eye doctors may use slightly different methods of testing. It is critical to determine through use of glasses or contact lenses which combination is best for each person prior to undertaking any surgical intervention. Be sure you understand this and have discussed with your surgeon which eye should be corrected for near, and if applicable, which eye for distance. If you have any doubts or uncertainty, surgery should be delayed until a solid comfort level is attained through use of monovision contact lenses. Under no circumstances should you consider undertaking monovision surgical correction before you are convinced it will be right for you. Once surgery is performed, it is not always possible to undo what is done, or to reverse the near and distance eye without some loss of visual quality.
Patient Initials
NEARVISIONSM CK® INFORMED CONSENT
PAGE 3
3) I understand that visual acuity I initially gain from NearVision CK could regress, and that my vision could go partially or completely back to the level it was immediately prior to having the procedure.
4) I understand that I may not get a full correction from NearVision CK and that I may require future enhancement procedures or the use of glasses or contact lenses. This procedure may also cause an increase in my astigmatism, which may cause blurred vision.
5) I understand that an overcorrection could occur, causing me to become nearsighted, and that his nearsightedness could be either permanent or treatable.
6) I understand that the correction that I can expect to gain from NearVision CK may not be perfect and it is not realistic to expect that this procedure will result in perfect vision, at all times, under all circumstances, for the rest of my life. I understand I may need glasses to refine my vision for some purpose requiring fine detailed vision after some point in my life, and that this might occur soon after surgery or years later.
7) I understand that there may be pain, scratchiness, a foreign body sensation, or slight dryness in my eye, particularly during the first 48 hours after surgery.
8) I understand that there may be increased sensitivity to light, and that I may experience glare and halos around lights. I understand this condition usually resolves within the first few weeks following treatment, but it also may be permanent.
9) I understand that there may be a “balance” problem between my two eyes after NearVision CK has been performed on one eye, but not the other. This phenomenon is called anisometropia. I understand that my first eye may take longer to heal than is usual, prolonging the time I could experience anisometropia.
10) I understand I may temporarily experience corneal haze, small round hazy areas where the cornea was heated during the NearVision CK treatment. This haze will usually fade over time and may only be visible with a microscope within 3 months following surgery.
11) I understand that there is a natural tendency for the eyelids to droop with age and that eye surgery may hasten this process.
12) I understand that I may be given medication in conjunction with the procedure. I understand that I must not drive for at least one day following the procedure and until I am certain that my vision is adequate for driving.
13) I understand that the follow-up effects of NearVision CK are unknown, and that NearVision CK has not been in use long enough to measure long-term effects (those occurring after 10 years or more) following the procedures, and that unforeseen complications or side effects could occur.
14) I understand that NearVision CK will not prevent me from developing naturally occurring eye problems, such as glaucoma, cataracts, retinal degeneration or retinal detachment.
15) I understand that, as with all types of surgery, there is a possibility of complications due to anesthesia, drug reactions, or other factors that involve other parts of my body. I understand that, since it is impossible to state every complication that may occur as a result of surgery, the list of complications in this form may not be complete.
Patient Initials
NEARVISIONSM CK® INFORMED CONSENT
PAGE 4
Patient Statement of Acceptance and Understanding
I have read and understand the information in the Patient Information booklet that has been provided to me. The details of the procedure known as NearVision CK have been presented to me in this document and explained to me by my ophthalmologist. My ophthalmologist has answered all my questions to my satisfaction. I therefore consent to NearVision CK surgery.
I give permission to my ophthalmologist to record on video or photographic equipment my procedure, for purposes of education, research, or training of other healthcare professionals. I also give my permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand NearVision CK. I understand that my name will remain confidential, unless I give subsequent written permission for it to be disclosed outside my ophthalmologist’s office or the center where my NearVision CK procedure will be performed.
I have had a successful trial of monovision or have a history of monovision wear using glasses or contact lens. __________ (please initial).
I consent to having my ___________ (indicate “right” or “left”) eye corrected for near vision.
Patient Signature Date
Witness Signature Date
I have been offered a copy of this consent form (please initial)
Conductive Keratoplasty (CK) for Hyperopia
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NOTE: THIS FORM IS INTENDED AS A SAMPLE FORM. IT CONTAINS THE INFORMATION OMIC RECOMMENDS YOU AS THE SURGEON PERSONALLY DISCUSS WITH THE PATIENT. PLEASE REVIEW IT AND MODIFY TO FIT YOUR ACTUAL PRACTICE. GIVE THE PATIENT A COPY AND SEND THIS FORM TO THE HOSPITAL OR SURGERY CENTER AS VERIFICATION THAT YOU HAVE OBTAINED INFORMED CONSENT.
Version 11/01/2006
INFORMED CONSENT FOR CONDUCTIVE KERATOPLASTY (CK) FOR THE CORRECTION OF HYPEROPIA (FARSIGHTEDNESS)
INTRODUCTION
This information and the Patient Information booklet are being provided to you so that you can make an informed decision about the use of a device known as the Viewpoint CK System, to perform CK. CK is one of a number of alternatives for correcting farsightedness. The CK treatment utilizes a controlled release of radiofrequency (RF) energy to increase the temperature of corneal tissue. The treatment is applied with a probe that is introduced 8 to 32 times into the cornea in a circular pattern, which results in an increased curvature of the cornea to correct your vision. The correction you achieve from CK may be temporary.
CK is an elective procedure: There is no emergency condition or other reason that requires or demands that you have it performed. You could continue wearing contact lenses or glasses and have adequate visual acuity. This procedure, like all surgery, presents some risks, many of which are listed below. You should also understand that there may be other risks not known to your doctor, which may become known later. Despite the best of care, complications and side effects may occur; should this happen in your case, the result might be affected even to the extent of making your vision worse.
ALTERNATIVES TO CK
If you decide not to have CK, there are other methods of correcting your farsightedness. These alternatives include, among others, eyeglasses, contact lenses, and other refractive surgical procedures.
PATIENT CONSENT
In giving my permission for CK, I understand the following: The long-term risks and effects of CK are unknown. I have received no guarantee as to the success of my particular case. I understand that the following risks are associated with the procedure:
VISION THREATENING COMPLICATIONS
I understand that it is possible that damage to my cornea could also be caused by scarring, ulceration, or an eye infection that could not be controlled with antibiotics or other means.
NON-VISION THREATENING SIDE EFFECTS
I understand that visual acuity I initially gain from CK could regress, and that my vision may go partially or completely back to the level it was immediately prior to having the procedure.
I understand that I may not get a full correction from my CK procedure and this may require future enhancement procedures or the use of glasses or contact lenses. This procedure may also cause an increase in my astigmatism, which may cause blurred vision.
I understand that an over-correction could occur, causing me to become nearsighted, and that this nearsightedness could be either permanent or treatable.
I understand that the correction that I can expect to gain from CK may not be perfect and it is not realistic to expect that this procedure will result in perfect vision, at all times, under all circumstances, for the rest of my life. I understand I may need glasses to refine my vision for some purposes requiring fine detailed vision after some point in my life, and that this might occur soon after surgery or years later.
Patient Initials
I understand that there may be pain, scratchiness, a foreign body sensation, or slight dryness in my eye, particularly during the first 48 hours after surgery.
I understand that there may be increased sensitivity to light. I understand this condition usually resolves within the first few weeks following treatment, but it may also be permanent.
I understand that there may be a “balance” problem between my two eyes after CK has been performed on one eye, but not the other. This phenomenon is called anisometropia. I understand this would cause eyestrain and make judging distance or depth perception more difficult. I understand that my first eye may take longer to heal than is usual, prolonging the time I could experience anisometropia.
I understand I may temporarily experience corneal haze, small round hazy areas where the cornea was heated during the CK treatment. This haze will usually fade over time and may only be visible with a microscope within 3 months following surgery.
I understand that if I currently need reading glasses, I will still likely need reading glasses after this treatment.
Even 90% clarity of vision is still slightly blurry. Enhancement surgeries can be performed when vision is stable UNLESS it is unwise or unsafe. An assessment and consultation will be held with the surgeon at which time the benefits and risks of an enhancement surgery will be discussed.
I understand that there is a natural tendency of the eyelids to droop with age and that eye surgery may hasten this process.
I understand that the follow-up effects of CK are unknown and that CK has not been in use long enough to measure long-term effects (those occurring after 10 years or more) following the procedures, and that unforeseen complications or side effects could occur.
I understand that I may be given medication in conjunction with the procedure. I understand that I must not drive for at least one day following the procedure and not until I am certain that my vision is adequate for driving.
I understand that, as with all types of surgery, there is a possibility of complications due to anesthesia, drug reactions, or other factors that may involve other parts of my body. I understand that, since it is impossible to state every complication that may occur as a result of any surgery, the list of complications in this form may not be complete.
PATIENT’S STATEMENT OF ACCEPTANCE AND UNDERSTANDING
I have read and understand the information in the Patient Information booklet that has been provided to me. The details of the procedure known as CK have been presented to me in detail in this document and explained to me by my ophthalmologist. My ophthalmologist has answered all my questions to my satisfaction. I therefore consent to CK surgery.
I give permission for my ophthalmologist to record on video or photographic equipment my procedure, for purposes of education, research, or training of other health care professionals. I also give my permission for my ophthalmologist to use data about my procedure and subsequent treatment to further understand CK. I understand that my name will remain confidential, unless I give subsequent written permission for it to be disclosed outside my ophthalmologist’s office or the center where my CK procedure will be performed.
Patient Signature Date
Witness Signature Date
I have been offered a copy of this consent form (please initial)
Ensure Coverage for Your Refractive Surgery
By Kimberly Wittchow
OMIC Legal Counsel
Being specialists in the underwriting and management of risk for the
practice of ophthalmology, OMiC makes sure that all insureds are individually reviewed and approved for their unique practices. therefore, OMiC’s policy excludes all refractive surgery until the company has had an opportunity to review the credentials and experience of ophthalmologists in the performance of each type of refractive surgery. Once approved, these services are covered at full policy limits by endorsement to the policy. no additional premium is charged for this coverage. however, coverage applies only to the specific procedure(s) added by endorsement. if an insured who has been approved for one type of procedure would like to perform other types of refractive surgery, he or she must apply and undergo under- writing review and approval for each additional type of procedure.
OMiC’s refractive surgery endorse- ments all have a common condition for coverage to apply: the procedure must be “performed within OMiC’s underwriting requirements or any exceptions to the requirements granted in writing by OMiC.” specific procedures have their own require- ments, and there is also an overall set of refractive surgery requirements applicable to all. these requirements, which address patient selection criteria, informed consent processes, and post- operative care, among other issues, must be met in order for a claim to be covered. All applicants for refractive surgery receive these requirements, and, in their supplemental application, they warrant and represent that they will abide by these rules and deviate from them only after approval on a case-by-case basis from OMiC. to view OMiC’s most current underwriting requirements for refractive surgery, go to the Refractive surgery information page of OMiC’s web site (accessible from the “Favorites” section of OMiC’s home page or by selecting “Products,” then “Professional Liability”) and select the procedure of your choice within the supplemental refractive surgery questionnaires.
the reasons for these requirements are threefold. Performance of refrac- tive surgery procedures within these parameters, based on sensible medical practice and sound risk management principles, should reduce the likeli- hood of unanticipated outcomes, and consequently, claims. they also protect the insured if a claim does arise, as procedures performed within the requirements are more defensible. the requirements also protect the company and its member-insureds, since more defensible claims protect the financial solvency of the company and there- fore enable OMiC to continue to operate for the benefit of all insureds.
the requirements were implemented by OMiC’s Board of Directors, under the guidance of the underwriting Committee, composed entirely of ophthalmologists, including refractive surgery specialists. they are continually reviewed and updated as necessary, with nearly all revisions to date expanding coverage. OMiC’s requirements with respect to patient selection are never more restrictive than the FDA on-label requirements and are generally more permissive. information gleaned from past refractive surgery claims, input from defense attorneys, and studies such as the one discussed in this issue’s lead article by Anne Menke, together with personal experience and expertise, all help our Board develop OMiC’s refractive surgery requirements. On occasion, the Board also seeks outside input from respected leaders in the refractive surgery community before implementing requirements.
in addition to the underwriting requirements for refractive surgery procedures, OMiC also has specific postop care requirements found in the policy itself in section iii. Common
exclusions, A.16. For coverage to apply, the insured must meet these conditions: (a) the insured operating ophthalmologist or an on-call or locum tenens ophthalmologist must perform the patient’s postoperative care throughout the patient’s recovery period; (b) the insured operating ophthalmologist must (i) refer the patient to a licensed ophthalmologist or other licensed physician as appropriate and (ii) obtain the patient’s informed consent for planned comanagement prior to surgery; or (c) the insured operating ophthalmologist must (i) arrange for a portion of the outpatient postoperative care to be rendered by a non-physician provider who is clinically competent and lawfully able to provide that care and (ii) obtain the patient’s written informed consent for planned comanagement prior to surgery. such delegated postoperative care must be provided under the insured operating ophthalmologist’s supervision. in addition to this postop care exclusion, which applies to all ophthalmic surgeries, the refractive surgery requirements oblige the operating surgeon or a designated ophthalmologist to perform the first postop visit. together, OMiC believes these requirements best protect the insured operating ophthalmologist while providing flexibility in the provision of postoperative care by comanaging providers. since the operating ophthalmologist is ultimately responsible for the outcome of his or her surgery, we want to facilitate his or her oversight, or proper delegation of the management, of postoperative care.
OMiC’s Board is constantly balancing patient safety, claims defensibility, and its fiduciary duty to insureds with the company’s desire to cover insureds for their growing expertise in new and modified procedures. so far, we’re confident we’ve gotten it right since OMiC’s claims experience is significantly better than the industry average. if you have any questions or comments about OMiC’s refractive surgery requirements, please contact your underwriter.
