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Re: [IP] Followed Pam Brown's Advice - Filed Grievance w/Kaiser Permanente



"HUMALOG DOES NOT HAVE THE FDA APPROVAL TO BE USED IN A PUMP THEREFORE IT
CANNOT BE COVERED UNDER PART B."

This sounds like old information, there was a time when Ely Lilly had not
submitted for use in a pump (I think before 1996) as recently as 2011 the
approval was updated see below:

INDIANAPOLIS, June 8, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
today announced that the U.S. Food and Drug Administration (FDA) approved the
company's supplemental new drug application (sNDA) with the following updates
to the Humalog label:

continuous insulin infusion pump therapy in children 4 years of age and over
with type 1 diabetes
extension of the time-in-use in the external pump reservoir to a maximum of
seven days; and
extension of the time-in-use of the infusion set and of the infusion set
subcutaneous insertion site to a maximum of three days.

Based on the updated label, people with type 1 diabetes using Humalog for pump
therapy can use the insulin in the pump reservoir for up to seven days and
should change the infusion set and infusion set insertion site at least every
three days. The previous label indicated that Humalog in the external insulin
pump reservoir should be replaced and a new infusion site selected every 48
hours or less.

Defiantly file a  challenge, and you might want to copy the Medicare help
line.



Mike
.
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