Risk Management



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.

Please refer to OMIC's Copyright and Disclaimer regarding the contents on this website

Leave a comment



Six reasons OMIC is the best choice for ophthalmologists in America.

#1. Consistent return of premium.

Publicly-traded insurance companies exist to make profits for shareholders while physician-owned carriers often return profits to their policyholders. Don’t underestimate this benefit; it can add up to tens of thousands of dollars over the course of your career. OMIC has one of the most generous dividend programs for ophthalmologists and has returned more than $20 Million to our members through dividends.

61864684