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.