[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