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Will my policy cover me for the treatment of eyelash loss using Latisse™ or similar products?
Products that alter the structure or function of the body, such as those that increase the growth of eyelashes, are classified as drugs and, as such, must prove their safety and efficacy in human tests. Similarly, products made from ingredients with well-known therapeutic uses may also be considered by the FDA to be drugs subject to regulatory approval. In December 2008, the FDA approved Latisse™ for hypotrichosis of the eyelashes. As of March 2009, no other drug has specifically been approved by the FDA for this use.
Your OMIC policy covers you for the direct patient treatment you provide, including the prescribing or dispensing of drugs. Coverage is not limited exclusively to the use of FDA-approved drugs and devices, such as Latisse™. Your policy coverage will also extend to the off-label use of approved drugs and to the use of unapproved drugs, but such practices present increased risk. Please read the feature article of the Spring 2003 Digest, “When FDA Leaves Doctors to Their Own Devices,” for additional information regarding the off-label and unapproved use of drugs. Clinical research or trials conducted under and in accordance with an American IRB-approved protocol are also covered under your policy.
Please click here to access a sample consent form for treatment of hyopotrichosis with Latisse.
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