Policyholder Services

I will be offering autologous serum tears to our patients and will draw blood and produce the drops onsite. Does my OMIC policy cover this?

Yes, coverage will apply to both the preparation as well as the prescription and use of autologous serum eye drops by insured ophthalmologists. The use of autologous serum tears is widely utilized and accepted in the management and possible treatment of difficult clinical conditions (such as graft versus host disease, Stevens Johnson Syndrome, and severe dry eye) that do not respond to other treatments. While the OMIC policy, like most medical professional liability policies, contains a product exclusion that excludes coverage for the designing, producing, manufacturing, assembling, distributing, marketing or selling of any medical device or other product, we consider the preparation of autologous serum tears for the insured’s own patients to be a component of direct patient treatment rather than the production of a “product.” As such, the product exclusion does not apply to this activity.

One concern regarding this therapy is the possibility of contamination, which could result in serious infection. Technical procedures such as sterile manipulation of the bottles and the blood, as well as clear instructions to the patient about the need to keep the bottles refrigerated and about possible symptoms of discomfort or blurred vision, are helpful and are recommended to enhance the safety of this therapy. For additional advice or assistance in minimizing your liability exposure relating to the use of autologous serum eye drops, please contact an OMIC risk management representative by calling (800) 562-6642, option 4.

We also encourage you to carefully review your state’s compounding laws. The preparation of autologous serum eye drops may be viewed by regulatory agencies as “compounding” subject to all applicable legal statutes.

Updated 6/28/2018

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