What is OMIC’s position regarding use of intravitreal anti-VEGF (IVAV) agents for treatment of ROP?
By Betsy Kelley, VP Product Management
Laser surgery remains the current standard treatment for ROP; however, other means of arresting ROP are sometimes needed. Some babies are too sick to tolerate the anesthesia needed during the surgery. In others, the abnormal vessels are in an area that the laser cannot safely reach, or the view is obstructed by blood or a persistent tunica vasculosis lentis. Some infants have disease that persists despite laser treatment. In these situations, intravitreal injection of anti-VEGF agents (“IVAV”) may be indicated.
Adult patients with retinal conditions due at least in part to VEGF have been successfully treated for many years now with intravitreal injections of anti-VEGF agents such as AvastinTM (bevacizumab), MacugenTM (pegaptanib), LucentisTM (ranibizumab), and EyleaTM (aflibercept). ROP is similar to certain retinal conditions in adults, prompting clinical trials on the use of IVAV in neonatal populations. Published reports of IVAV from both clinical trials and “off-label” use suggest that it can be effective and does not—so far—appear to produce many serious short or long-term side effects. However, the efficacy, safety, and long-term consequences have not yet been definitely proven, and cases of late recurrence of ROP have been reported. Concerns about IVAV both as primary or salvage therapy have been addressed in the literature and at eye society meetings. In addition, many questions are currently being studied and debated, such as agent, dosage amount, volume, timing of injections, length of follow-up, and contraindications. Despite these uncertainties, when faced with aggressive or refractive ROP, ophthalmologists at times feel there is no other prudent choice but to treat ROP with IVAV.
Because off-label use of approved drugs and devices is a necessary and legal part of the practice of medicine and use of non-approved drugs and devices is also appropriate in certain situations, OMIC’s policy does not contain any provisions or exclusions that would prohibit coverage for such activities outside of clinical trials. Additionally, OMIC’s policy does not contain any exclusions regarding the treatment of ROP, either traditionally or with IVAV. However, given the potential liability concerns with this new treatment modality, OMIC carefully underwrites physicians who administer intravitreal anti-VEGF agents for the treatment of ROP.
To further manage the potential liability concerns associated with the off-label use of IVAV for the treatment of ROP, OMIC has developed risk management recommendations and a sample consent form for anti-VEGF treatment of ROP. OMIC policyholders who administer anti-VEGF medications for ROP are strongly encouraged to call OMIC Risk Manager Anne M. Menke, RN, PhD at 1.800.562-6642, extension 651 to discuss this treatment modality. This is a confidential call.
Telephone Screening of Ophthalmic Problems: Sample Contact Forms and Screening Guideline
CLICK ON DOWNLOAD FOR THE TOOLKIT WITH ALL FORMS
Each day, countless patients call their ophthalmologist to report problems and seek advice. During the day, physicians rely upon their office staff to screen these calls and schedule appointments. After-hours, ophthalmologists themselves field many calls while providing coverage for their own and other physicians’ practices, as well as for the Emergency Departments of hospitals.
Making medical decisions on the basis of the limited information obtained over the telephone is, therefore, a risky—albeit necessary—aspect of ophthalmic practice. Indeed, OMIC’S claims experience confirms that inadequate telephone screening, improper decision-making, and lack of documentation all play a significant role in ophthalmic malpractice claims. Negligent telephone screening and treatment of postoperative patients is especially likely to result in malpractice claims.
Our Telephone screening toolkit with forms provides a sample telephone screening form for staff, an appointment guideline, and a form for after-hours care.
OMIC policyholders may call our confidential Risk Management Hotline for assistance. Email us at riskmanagement@omic.com, or call us at 800-562-6642, option 4.
The Ophthalmologist’s Role in Emergency Care: On-Call and Follow-up Duties Under EMTALA
The Ophthalmologist’s Role in Emergency Care: On-Call and Follow-up Duties Under EMTALA
Anne M. Menke, R.N., Ph.D.
OMIC Patient Safety Manager
“The Ophthalmologist’s Role in Emergency Care” focuses on on-call and follow-up duties. It is designed as a companion piece for “EMTALA: An Overview for Ophthalmologists,” which provides information on the basic obligations hospitals and physicians have under EMTALA (available online in the “Risk Management Recommendations” section at www.omic.com). The EMTALA regulations contain many defined terms. Ophthalmologists should be careful to distinguish between their usual understanding of these terms (e.g., emergency medical condition) and the legal definition given in the EMTALA regulations. Words with special legal meaning are placed in italics and explained as necessary. For ease of use, this discussion is organized in a question and answer format and contains legal information from attorneys with special expertise in this arena. At times, the legal situation is not clear. In those instances, ophthalmologists should exercise their medical judgment and prioritize patient safety.
Download the complete document.
Leaving practice toolkit
Ophthalmologists leave practices for many reasons, including illness, retirement, changes in employment status, and personal or family needs. Both the individual ophthalmologist and the practice need to take steps in order to promote continuity of care, prevent allegations of abandonment, and ensure that all involved ophthalmologists have access to the medical records in the event the care is ever called into question. At the same time, both parties will need to take into consideration the terms of their contracts and the requirements of state and federal law.
This Leaving Practice Toolkit addresses the risks posed when an ophthalmologist retires or leaves a practice. Both ophthalmologists and groups need to take steps to prevent patient harm and reduce their liability exposure in these scenarios. Prepare your exit strategy early. Planning well in advance of the departure date helps all involved. While nothing can completely eliminate the stress of practice changes, much can be done to limit the likelihood of lawsuits.
Click on the “Download” button to access the toolkit, which contains sample change of practice letters.
Revised 2024
