Risk Management



ROP: Intravitreal Anti-VEGF Injections Risk Management Recommendations

Anti-VEGF Intravitreal Injections for ROP:

Anti-VEGF and ROP: Risk Management

OMIC ROP Task Force

OMIC has devoted considerable time and effort to improve the safety of premature infants and reduce the liability of the care that ophthalmologists provide to these patients. We are grateful to the ophthalmologists on our Board and Committees for their expertise. AntiVEGF for ROP contains a risk management analysis and recommendations. It reflects the input of the following Board, Committee, and staff members: Anne M. Menke, RN, PhD; Denise Chamblee, MD; Robert Gold, MD; Betsy Kelley; Trexler M. Topping, MD; Robert Wiggins, MD; and George Williams, MD.

UPDATE #1: CHANGES TO FOLLOW-UP REQUIREMENTS

The OMIC Board adopted the following revised requirements in May of 2016. Infants treated for ROP with IVAV must be followed until 1) full vascularization in close proximity to the ora serrata to 360° occurs or 2) the avascular retina has been successfully treated with laser (e.g., no skip areas).

Ophthalmologists may use their professional judgment on continued monitoring in the following circumstances if no treatment endpoint has been reached 3 months after the injection: 1) low-grade disease that is clearly and slowly improving, 2) stage 1 disease that is unchanged for 2 months, 3) no disease, no ROP, but incomplete vascularization, and 4) infants with DNR (do not resuscitate orders.

UPDATE #2: RECOMMENDATIONS AND ROP CONSENT FORMS UPDATED

OMIC and the Task Force want to let you know of some new studies on the effect of Avastin on the infant’s neurodevelopment. We have revised our ROP documents and consent forms to address this research. Pediatrics published a report1 showing that the odds of severe neurodevelopmental disabilities was 3.1 times higher in infants treated with Avastin than those treated with laser. Another article2 showed increased odds only in infants treated with both Avastin and laser.

Research is ongoing to determine if Avastin and other anti-VEGF drugs are safe. In the meantime, we all have to explain what we do know about these drugs to parents whose infants need treatment for ROP.

Revised consent forms for laser and anti-VEGF drugs

We reviewed our current consent forms and felt they needed to be revised to address this new information. We took this opportunity to produce “plain-language” versions of the forms. We hope you agree with us that these new consent forms are easier for parents and caregivers to understand.

 

Questions?

Please contact OMIC Risk Manager Anne Menke if you have any questions about our ROP forms or recommendations. You may reach Anne at 415-202-4651 or at amenke@omic.com.

 

  1. Warren J, Luu TM, Superstein R, et al. Neurodevelopmental Outcomes Following Bevacizumab Injections for Retinopathy of Prematurity. Pediatrics. 2016; 137 (4): e20153218. http://pediatrics.aappublications.org/content/early/2016/03/16/peds.2015-3218
  2. Lien R, Yu M-H, Hsu K-H, Liao P-J, Chen Y-P, Lai C-C, et al. (2016) Neurodevelopmental Outcomes in Infants with Retinopathy of Prematurity and Bevacizumab Treatment. PLoS ONE 11(1): e0148019. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0148019

 

OMIC RESOURCES FOR ROP CARE

Please review our analysis of ROP malpractice claims, as well as toolkits for both hospital- and office-based care. They are available at  (please see “Retinopathy of Prematurity: Creating a Safety Net (2nd edition)”, “Retinopathy of Prematurity: Materials for Creating a Hospital ROP Safety Net,” and “Retinopathy of Prematurity: Materials for Creating an Office ROP Safety Net,” all available at www.omic.com in the Risk Management Recommendations section). Our sample consent form for laser treatment of ROP is included in the hospital toolkit.

To further reduce the risk and severity of ROP malpractice claims, OMIC conducts an underwriting review on an annual basis of all insured physicians who provide ROP care, and has mandated certain loss prevention actions. If you have any concerns about the requirements or any other aspect of ROP care, please contact OMIC Risk Manager Anne Menke by calling 800.562-6642, extension 651 or via email at amenke@omic.com; the assistance is confidential.

 

 

 

 

 

 

 

 

 

 

 

 

 


 

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#3. Best at defending claims.

An ophthalmologist pays nearly half a million dollars in premiums over the course of a career. Premium paid is directly related to your carrier’s claims experience. OMIC has a higher win rate taking tough cases to trial, full consent to settle (no hammer) clause, and access to the best experts. OMIC pays 25% less per claim than other carriers. As a result, OMIC’s base rates have consistently averaged approximately 15% lower than multispecialty carriers in the U.S.

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