AAO prescribing recommendations for Latisse
To supplement OMIC’s Latisse resources, we encourage ophthalmologists and patients to visit the American Academy of Ophthalmology’s What You Should Know About Latisse page of the EyeSmart education site.
Download the Academy’s position paper on Latisse using the toolbar above.
Hemorrhage Associated with Ophthalmic Procedures
OMIC claims data indicates that ophthalmologists who do not properly screen patients for bleeding risks and manage hemorrhage when it occurs often face malpractice lawsuits. An OMIC closed case study of hemorrhage following blepharoplasty that resulted in a large settlement is presented to highlight errors in management that led to blindness and a subsequent lawsuit. Other parts of this article address how to screen patients for bleeding risk, monitor for hemorrhage, and begin to manage an orbital compartment syndrome.
We would like to thank OMIC Board member Dr. Ronald Pelton for his assistance with these documents.
OMIC risk management recommendations: Hemorrhage and Ophthalmic Procedures
Anticoagulant form for patients
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.
Coverage for Medical Spa Liabilities
By Kimberly Wittchow
OMIC Legal Counsel
Digest, Spring 2009
There are liability risks when providing medical spa services, as well as in supervising or directing medical spa services and in owning and operating medical spas. The OMIC professional liability policy and broad regulatory protection policy cover some of these risks, but not all. Therefore, it is imperative to operate within OMIC’s coverage provisions or secure additional coverage elsewhere.
Medical Malpractice: Ophthalmologists
The OMIC policy (Coverage Agreement A) covers ophthalmologists for their direct patient treatment as long as it is within the ordinary and customary scope of practice of ophthalmologists and not specifically excluded within the policy language or by endorsement. Insureds who have limited their practice and are in a coverage classification other than full surgery (Surgery Class 3) must carefully check the wording of the endorsement pertaining to their class to ensure that the medical spa treatments they are performing are covered under their class. For example, to perform skin rejuvenation/tightening using radio frequency, one must be in Surgery Classes 2 or 3. However, Surgery Class 1 physicians may perform injections of Botox or collagen and other fillers. Your underwriter can provide a list of typical medical spa procedures and their minimum coverage classification requirements.
Medical Malpractice: OMIC-Insured Medical Spas, Directors, and Owners
OMIC offers coverage to medical spas under Coverage Agreement C, subject to underwriting review and approval. A specific medical spa application form is required and the facility must abide by OMIC’s underwriting requirements in order to be eligible for coverage. Coverage is available only for medical spas that are located within the owner’s ophthalmic practice or in the same building, and OMIC insureds (and immediate family) must hold at least 50% of the ownership. If the medical spa is an insured entity, then any persons affiliated with the medical spa as members, officers, directors, partners, or shareholders, including as medical directors, supervising physicians, or prescribing physicians (collectively “directors and owners”), will also be covered, but only in their capacity as directors and owners.
Coverage Agreement C covers claims against the spa and directors and owners for direct patient treatment attributed to the entity itself (occurring, for example, if the entity’s policies or procedures lead to the injury), as well as professional committee activity claims against its directors and owners (e.g., negligent credentialing of the utilizers of the medical spa). It also provides vicarious liability for the entity and its directors and owners, but only when the person for whom the spa, director, or owner is being held responsible was acting within the scope of his or her licensure, training, and professional liability insurance coverage, if applicable. It is imperative that medical directors and owners understand the licensure requirements for the various medical spa treatments offered at their facilities.
Medical Malpractice: Non-Insured Medical Spas, Directors, and Owners
OMIC’s policy specifically excludes coverage of an insured acting as a “medical director, supervising physician, or prescribing physician of a medical spa, not named in the Declarations.” This means that if the medical spa is not listed on the Declarations, the insured ophthalmologist is not covered for liability as a medical director of the spa, even though he or she is insured for direct patient treatment rendered at the medical spa.
Medical Malpractice: Ancillary Staff
Ancillary staff who provide services at medical spas, such as aestheticians, aesthetic nurses, and RNs, are covered by OMIC only if the employing physician or medical spa is named on the Declarations (Coverage Agreement B). Even if OMIC insures a physician owner of a non-OMIC-insured medical spa, there is no OMIC coverage for ancillary staff employed by the medical spa. Such ancillary staff employees should make sure the medical spa’s non-OMIC professional liability insurance covers them. under the OMIC policy, ancillary staff members have direct liability coverage only if they are acting within the scope of their training, licensure, and employment by and for the direct benefit of the employing insured named on the Declarations. Not only does the coverage agreement require appropriate licensure, there is also a specific exclusion that excludes coverage for direct patient treatment by any health care providers who don’t hold the required licenses, certifications, or accreditations to provide the services in question.
Licensure Actions
OMIC’s policy also provides defense-only coverage (paying up to $25,000 in legal fees) for any investigation, disciplinary proceeding, or action for review by a regulatory agency, such as the medical board, arising from a patient complaint of an injury resulting from the insured’s direct patient treatment at a medical spa or elsewhere. This coverage does not include any fines or penalties and doesn’t cover investigations based on other people’s actions. This coverage is only for ophthalmologists and would not protect nurses or other licensed staff being investigated for scope of practice violations. If an injury to a patient is not alleged, but a licensing proceeding is instituted against the ophthalmologist by a state licensing authority, the OMIC Broad Regulatory Protection Policy will cover legal expenses for the investigation up to $25,000 (with a $1,000 deductible).
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
