I've never posted before, but have been enjoying reading about everyone else's victories and soaking in all the advice I can get.
Unfortunately, my insurance denied VSG as "experimental or investigational". I did use my appeals, however I am not giving up that easily. Fortunately, my employer is open to helping me find a way for our insurance to justify covering the procedure - but under our current plan document guidelines. (We are a self-funded program.) I've been working with an insurance consultant to my employer (works for the pre-authorization co. who administers our plan) who is open to my feedback and has been researching alongside me.
According to our plan document, the procedure qualifies in all areas except one. The one point that is causing them to say this is experimental is that they say VSG is in phase 3 clinical trials. I have searched and searched websites. Called the FDA and NIH. Emailed the FDA and NIH. Yet...all to no avail. I cannot find anything that says what phase of trials the VSG (or LVSG or SG...or whatever other acronym you can come up with) as a stand alone procedure is in. I can find information about trials researching the impact of VSG on specific co-morbidities, but they all seem to be narrowing the research field.
Does anyone have any information about this or any ideas as to where else I could look. The insurance consultant also has some of his researchers trying to locate this information because they have been "told" this, but have no hard evidence that this is indeed the case. The last time I spoke with him, he said "you may have found a loop-hole". I'd like to make sure this isn't a loop-hole, but a wide-open door -- for all of us.
My plan document considers any stage I, II or III clinical trial procedure as experimental. How do I prove otherwise?
My plan document has the following for Experimental or Investigational procedures...meaning any procedure which:
1. Is considered by any governmental agency, such as the FDA, NIH or Centers for Medicare and Medicaid services as noted in the Medicare Coverage Issue Manual, to be experimental or investigational; OR
2.Cannot be lawfully marketed without approval of the FDA; OR
3. "Reliable Evidence" shows that the procedure is the subject of ongoing phase I, II or II clinical trials or under study to determine its safety, its efficacy or its efficacy compared with the standard means of treatment or diagnosis; OR
4. "Reliable Evidence" shows that the consensus of opinion among experts regarding the procedure is that further studies or clinical trials are necessary to determine it efficacy or its efficacy as compared with the standard means of treatment or diagnosis; OR
5. Do not have a documented success ratio of fifty percent for a period of two years.
"Reliable Evidence" shall mean published reports and articles in the authoritative medical and scientific literature, or the written protocol or written informed consent used by the treating facility or of another facility studying substantially the same procedure.
It seems the only real sticking point is #3. I did call medicare myself and they verified that medicare IS covering VSG. They are mailing evidence of that to me - expected delivery of April 1st (how's that for gov't service?).
I would appreciate any help or advice for how I can work to refute their stance.
Thank you!