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RE: [IP] FDA approval a way of avoiding payment

A. Bender, M. D. [mailto:email @ redacted] wrote:

> Sorry Jim H but they are a little behind on what is 
> available. 

Am I the Jim H. you are addressing?  I work for CDC, not FDA nor HCFA.

Let's clarify something about FDA approval -- the FDA approves items for
sale and distribution.  Humalog is not approved for use with a pump.  That
means that neither a pump manufacturer nor Lilly can indicate use of these
two things together, either in advertising or in any instructions, nor can
it be part of the package insert on the H, etc.

BUT, as you mention, *use* of a drug, etc., is controlled under the
authority of a physician or equivalent.  As long as one has a prescription
for H, it may be properly and legally used in a pump.

> that doesn't mean they are no good or will cause harm. by not 
> approving 
> something, Medicare can avoid payment for something or tell 
> you that they 
> won't pay because the use is experimental. Like certain kinds 
> of chemotherapy

What HCFA does often has little to do with what FDA, CDC, or anyone else
does.  In the use of an "unapproved" drug, the physician may have to
indicate medical necessity.  One of the big issues in the current political
scene is Medicare payment for prescriptions drugs - that is drugs received
for other than a hospitalization.

No company in the United States is permitted to charge for use of an
experimental drug.  Those costs are considered R and D, and the drugs are
not marketable for profit.

Jim Handsfield
mailto:email @ redacted OR
mailto:email @ redacted

The opinions expressed are my own and do not necessarily represent those of
my wife who runs this house and makes more important decisions than I do.
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