definitions of experimental and investigational

[sfmcfar]

Hi,

In preparation for my expected denial by MAMSI for my Charite, I reviewed their own definition of "experimental and investigational." MAMSI states in their own plan that a drug, device, treatment, or procedure is considered experimental if:

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1. It is not recognized, in accordance with generally accepted medical standards, as being safe and effective for your condition;
2. it requires approval by a governmental authority (including the FDA) before you can use it, but they have not granted that approval; or
3. it is the subject of a written protocol used by the treating facility for research, clinical trials, or other tests or studies to evaluate its safety, effectiveness, toxicity, or maximum tolerated dose.

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Now, I'm no lawyer, but refuting 2) is obvious since it's been approved by the FDA. I think that 1) is easily refutable since the FDA themselves used the exact words "safe and effective" in their decision to approve. But what about 3)? I know that there's a 5 year followup study to determine Charite effectiveness. But it would also seem that 3) would eliminate approving (for example) Prozac, since I'm sure there's some long-term study out there comparing Prozac to some other antidepressant.

Thoughts? Suggestions?

-stan

[sfmcfar]

One more question for all of you - it seems like most of the folks on this board don't fit the FDA approved criteria - multiple levels, wrong levels, etc, etc. I, on the other hand, meet the FDA requirements exactly. Has anyone out there been turned down by insurance that meets the FDA criteria for the Charite?

Thanks,

-stan

[Cat-mt]

Stan, I'm a walking perfect fit for the FDA requirement for the Charite. I only need 1 level L5-S1, have had back pain for over 5 years, have tried all other therapies for well over 4 years, i'm 41, other than my back i'm very healthly. I am an exact match according to the FDA requirements, however my insurance company said NO! Reason given is UNPROVEN. I do know that there are many of us "perfect fit" people out there that the insurance companies have said no to, and there are many that have been approved by the insurance companies. It is a toss up as to who will get coverage and who won't, its all up to the individual companies. Cathy

[sfmcfar]

Cathy,

Thanks for posting - but not for the bad news.

[Alastair]

I don`t live in the USA but have seen documentation saying the FDA have approved ADR. People have had this proceedure paid for both overseas and in the USA

I am flabergasted
Best
Alastair

[jf110]

Stan,
I am also a perfect candidate for adr with one level L5S1 adr surgery. I have already been cleared by Dr. Blumenthal for Charite disc replacement at L5S1. However, my insurance company STILL WANTS TO CLAIM ADR EXPERIMENTAL,INVESTIGATIONAL. I just had my 2nd level appeal denied. During my appeal process i sent BCBS a letter sent by certified mail requesting there internal guidelines they use to base adr experimental,investigational. I have yet to RECIEVE ANY INFORMATION FROM THEM ON WHAT THERE GUIDELINES ARE FOR CLAIMING ADR EXPERIMENTAL,INVESTIGATIONAL. THIS HAS BEEN GOING ON SINCE DECEMBER 2004 !!!. It is not over yet!!! Thanks, JF110

[Dave]

Stan, and anyone in the Appeals Vortex:

I fit the FDA guidelines as well as could be, but still was denied coverage -- just once so far. I have written to the insurance company and await a response. I'm 37, very fit, pain for years, tried multi other treatments, but disc space is about gone for L5-S1. Other discs look great on MRI. Reason for denial was basically "lack of information on procedure", and not fitting the policy's definition of "medical necessity". Both reasons are total BS.

My appeal letter is a bit long and dramatic, but I actually feel it might make a difference...maybe. If anyone thinks they might get ideas from it to use in their appeals, let me know and I'll post the text.

Keep the pressure on, it will work.

Dave

[cavalib]

Stan,
I am a perfect candidate for the Charite'. But I am being denied by Cigna. They are calling it "unproven/experimental."

[bmills]

Same with me. Perfect candidate. CIGNA says unproven/experimental. Preparing level three final appeal with independant review. They say that is final.

Let's hope the state assigned physician that does the independant review is going to see the light.

Brady

[bmills]

Stan, what level are you at in the appeals process?

Brady