Refractive Surgery Guidelines Revised
For OMIC’s current refractive surgery requirements (2022), please click here.
Shared Liability for ROP Screening
By Kim Wittchow, JD OMIC Staff Attorney
Examining premature infants for retinopathy of prematurity (ROP) is an important aspect of ophthalmic care. Ophthalmologists who perform this critical consultative function are providing a tremendous service to these infants and to the neonatal intensive care units (NICU) and supporting institutions that care for them. Because these institutions and ophthalmologists work together to reduce the likelihood that significant ROP will develop, they also should share the medical malpractice liability risk should a case of ROP advance to vision loss or blindness. If you perform ROP screening, you should know how your hospital handles this shared risk and take steps to limit your liability in the NICU.
Hold Harmless/Indemnification
One approach is to ask the hospital to hold you harmless and indemnify you for any liability you incur in performing ROP screening in the NICU. This means the hospital promises to absolve you of any responsibility for damages or other liability and to reimburse you for any loss you suffer arising from your provision of services in the NICU. This would be accomplished by inserting a hold harmless/indemnification clause in your ROP service contract with the hospital. Note, however, that many states limit the types of risks that can be transferred from one party (you) to another party (the hospital). Any indemnification agreement that you and the hospital enter into should be reviewed and/or drafted by legal counsel. Contact OMIC’s Legal/Risk Management Department for sample language.
An additional safeguard is for you to be named an “Additional Insured” under the hospital’s liability policy. This gives you direct access under the hospital’s policy to defense coverage for insured claims whether or not the hold harmless/indemnification provision is legally enforceable. However, “Additional Insured” status should not be obtained in lieu of a hold harmless/indemnification provision because the hospital’s insurance policy may not cover the loss.
Hospital-Provided or Funded Insurance
Another approach is for the hospital to provide you with additional insurance. Again, the specific provisions would be spelled out in your ROP service contract with the hospital. This hospital-provided insurance would coincide with your primary OMIC professional liability insurance. If you negotiate a primary or contributory policy with the hospital, then OMIC and the hospital most likely would share and cooperate in your defense and payment of any (covered) indemnity. (The OMIC policy describes how losses are apportioned when the OMIC policy and other insurance apply to the loss on the same basis.) However, if you negotiate an excess policy with the hospital, the hospital would not generally participate in the defense of the claim unless it is likely you will exceed your primary limits with OMIC. The excess limits would be available, though, if a judgment against you exceeds your policy limits with OMIC. Keep in mind that all determinations of coverage are case specific.
Another alternative is for the hospital to contribute toward payment of your insurance premiums. The AMA reports that hospitals are increasingly helping physicians pay their medical malpractice premiums to ensure that physicians continue to provide services at hospital facilities.
As an OMIC insured, one option for you is to raise your professional lia- bility limits and ask the hospital to reimburse you for the difference in premium. You should seek legal counsel when entering into these arrangements to ensure compliance with federal and state laws regulating hospital payments to physicians.
Damage Caps and Punitive Damages
When considering any of these options, you should be aware of state laws, such as those governing damage caps and the availability of punitive damages awards, because they will affect how much and what type of liability coverage you should seek. For example, if the state’s damage cap is $1 million and you have $2 million per occurrence/$4 million in the aggregate coverage, you can feel more secure that your limits will not be exceeded because of a jury award against you. However, if your state allows punitive damages awards, you might want to negotiate additional insurance from or indemnification by the hospital since the OMIC policy does not cover punitive damages. Your attorney should recommend the most appropriate and viable coverage alternatives and work with the hospital to draft the applicable terms.
You also should note that if a patient files a lawsuit, conflicts of interest may arise between you, the hospital, and other codefendants such as subsequent treating physicians. For example, you might disagree as to whose responsibility it was to provide follow-up ROP exams to a baby you examined once who was then transferred to another facility. In this situation, OMIC might exercise the right to separate counsel for its insured while still focusing on a unified defense.
Lipo-Dissolve No Longer Covered
In February 2008, the FDA issued the following (excerpted) statement regarding Lipo-Dissolve:
“the FDA is aware of the practice of using Lipo-Dissolve. Lipo-Dissolve is not FDA approved for any use… there are no FDA- approved drugs with an indication to dissolve fat. FDA cannot assure the safety and efficacy of these types of drugs. These are unapproved drugs for unapproved uses and FDA cannot guarantee consumers’ safety… the use of compounded drugs is not considered “off- label” use… FDA approval of a drug includes approved labeling for use, and means that the FDA has evaluated the safety and efficacy of a drug for a specific use and population. Once approved, a drug may be prescribed by a licensed physician for a use that, based on the physician’s professional opinion, is appropriate…but it is expected that the physician is well-informed about the product and that the “off-label” use is based on sound scientific rationale and adequate medical advice…” numerous medical associations, including the American society of Ophthalmic Plastic and Reconstructive surgery, have issued warnings regarding injection lipolysis and cautioned their membership against performing such treatments. in addition, several states seek to ban or regulate Lipo-Dissolve procedures.
As a result of these developments, the Board of Directors has determined that OMIC will no longer extend coverage for any Lipo-Dissolve, mesotherapy, or similar procedure unless performed as part of an investigational drug trial under an American IRB-approved protocol.
Message from the Chairman addresses coverage for cosmetic procedures and a spa setting
No area of ophthalmology is more controversial and difficult to underwrite than oculoplastic and oculofacial procedures. For this reason, OMIC has always had an oculoplastic specialist involved in making coverage decisions on what I will refer to here as “cosmetic” procedures. This includes past underwriting Committee chair, Michael J. Hawes, MD. Additionally, OMIC has maintained an ongoing educational cooperative venture with the American Society of Ophthalmic Plastic and Reconstructive Surgery since 1998. Thus, we feel very confident in our ability to assess the liability risks of ophthalmologists who perform cosmetic procedures and to establish the underwriting guidelines and requirements to minimize these risks. We believe it is because of these guidelines that we have a record of low frequency and severity of cosmetic surgery related claims.
Historically, these procedures were usually performed by oculoplastic specialists on established patients in a medical office or surgery center. With storefront medical spas now cropping up in malls and on street corners, patients can walk in and have laser hair removal, microdermabrasion, and other cosmetic procedures performed on the spot. Needless to say, this makes the underwriting process more challenging than when it simply involved individual ophthalmologists offering cosmetic procedures to their own patients in their own office or clinic.
Because cosmetic procedures are not generally included in ophthalmology residency programs, OMIC must verify that an applicant is qualified and has received the proper training to perform such procedures. Applicants are asked to provide information on the number of procedures they will perform annually, the areas of the body they will treat, the venue where they will provide these procedures, and their advertising of these procedures, if any. Applicants agree to abide by OMIC’s underwriting requirements and to inform us of any changes to their application responses. When OMIC is reasonably confident that the insured intends to offer these services in an ethical and professional manner with appropriate informed consent and preserve patient safety, coverage for cosmetic services will usually be approved.
The issue of where cosmetic procedures are rendered first arose in 2002 following FDA approval of cosmetic Botox. OMIC began to receive inquiries as to whether spas or even house parties were acceptable venues for injections. OMIC has been very clear that medical treatments such as Botox need to be provided in settings that have proper medical equipment and personnel.
“Medi-spas” present a hybrid environment that is not quite a medical office or clinic, but is more than a simple spa giving massages and facials. To further complicate matters, ophthalmologists may have an ownership interest in the medi-spa and/or serve as its medical director. Coverage for the liability risks associated with medi-spas may only be extended after an OMIC insured has completed a 10-page questionnaire. Failure to honestly complete this underwriting process puts the insured at risk of not being covered should a claim arise.
As long as ophthalmologists continue to expand their scope of practice, OMIC will continue to cover what they do and will work with insureds to carefully integrate new procedures into their practice with patient safety as the top priority.
Richard L. Abbott, MD OMIC Chairman of the Board
