Is VSG in Phase III Clinical Trials?

WI2AZ · March 13, 2010

Dr. Jossart,

My insurance is denying coverage based on VSG currently being in Phase III Clinical trials. I can find several trials related to VSG, but none that are studying the use of VSG as a stand alone procedure to treat morbid obesity. All the others are VSG and...some other co-morbidity or endocrine issue.

How can I find out for certain whether this is true or just an excuse on behalf of my insurance company? Any help you could offer would be greatly appreciated.

Thank you!

Dr. Jossart · March 16, 2010

Generally, terminology like this(Phase, clinical trials) refers to devices and medications. Procedures or techniques do not usually require a specific trial to be approved as there is no governing body that would approve or disprove them. The FDA approves devices but not procedures. Currently, Medicare does not approve the VSG but is reviewing it. Other insurance companies are probably following along with this.

WI2AZ · March 16, 2010

Thank you for responding.

In my recent research, I did speak with a Medicare representative (although I am not covered by Medicare). When I inquired about their coverage of VSG, she consulted with a supervisor and returned saying, that VSG would be covered if the person met the NIH criteria displaying a need for WLS. I also asked, to confirm, whether or not VSG was considered experimental or investigational by Medicare and she stated "no". I asked her to send written verification of this for my records and she said it would be mailed and that I could expect to receive it on or around April 1st. Could this be an indication that April 1st is when they're updating their position on it? It seems that April 1st is a long time to wait to receive information that was requested on March 10th.

Thank you for your help.