VSG in Phase III Clinical Trials? (long)

[WI2AZ 0]

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!

[LAN2k 18]

Can you use the evidence that Medicare will provide you with? I had straight medicare when I did my pre-op testing and at that time, August-Sept. 2009, Medicare did not approve the sleeve. I took a gamble and switched over to a medicare advantage plan "GHI Medicare PPO..." This plan was vague on weight loss surgery and when I called and asked I was told that they would cover it if it was deemed as medically necessary and that it was not excluded. My surgeon sent them a letter with all the test results and recommendations from various doctors and within 2 weeks I was approved! I think you may have an argument if you can get that information from medicare so hang in there and fight the good fight. Best wishes...keep us posted.

[janagirl33 0]

Hi its me again... Now I am being told that Medicare advantage plans decide according to Medicare guidelines right???? Wrong.. It depends on who is the administrator or contractor for your Medicare Advantage plan. I wish I had known this prior to choosing BCBS. I want the VSG not the RNY.. I can change to another plan by 31st of March, but which one?.. Did you advantage plan tell you that the sleeve was a covered benefit. Mine did but they still denied it. I never was told about investigational and my BMI is 46.5, HBP, pre diabetic with chronic family history of stroke, heart conditions due to obesity. I was having the surgery done on an outpatient basis but was discuraged from that because I would have been stuck with the entire bill. Thanks for your info .. It gives me hope to appeal this cause I think the VSG can be approved. Medicare reps actually gave me the cpt code 43775 sleeve gastrectomy and how much medicare will pay. So what is the non coverage crap?...:scared0:

[LAN2k 18]

Jana I switched to GHI Medicare PPOIII. They sent someone to meet with me at home and he was vague with me about the sleeve gastrectomy (he was clueless) but when I called I was told they would approve any weight loss surgical procedure if it was deemed medically necessary. It went through first shot. I can't promise you it will work for you but now is the time to switch so I'd really hustle and call which ever plans available to you in your area and try to nail it down. Maybe see if you have GHI coverage in your area. Best wishes I hope your strike it right.

[sleevegenie 0]

well, i was told the same thing by customer service at Anthem Blue Cross, they said if it is medically necessary they will pay for it, but when the request for approval was sent in they say oops sorry, this is still considered experimental. its being looked at now waiting for the insurance to make a decision, need the denial before i can appeal,, even tho i was told to appeal and the paperwork has been with the appeal board over a month, what a bunch of hooey,

[mila1013 0]

hi, i was wondering what the outcome was for you? this is interesting as i was trying to find the same information, it is a big secret or something? what is up with that? hope you are well

Mila

[sleevegenie 0]

well on day 30 of my appeal they said , "oh you can't appeal you haven't been denied this has to go to the utilization dept. who told me on 6 different calls that their dept didn't handle hmo. So the guy tells me that dept doesn't know that they do this?wth?? so it goes to them and they deny me and i requested an Independent Medical Review, which is 3 independent doctors review and decide your fate. I won with a vote of 2-1 in my favor and got my sleeve on 5/28. There is a copy of my appeal letter in my profile page. i couldn't be happier. Best of luck to you, let me know if i can help in any way Jeani