Help!

We have been struggling with getting answers to the following questions.
Any guidance would be GREATLY appreciated!!

I'm not certain that it makes a difference in your response to the following
questions, but I work at a private, nonprofit research foundation, which is
a division of a not-for-profit group medical practice engaged in providing
healthcare (a medical clinic).  We are not a hospital.

We have a couple of federal grants/contracts in which we are approaching the
level of incurring $100,000 per year per project in what we have defined as
"patient care costs".  An entity that we work with is suggesting that in
reaching this level, we are required to have a negotiated patient care rate
for purposes of conducting the related research activity.  My questions are
as follows:

1.      In the past, we have treated all patient related laboratory costs
(internally or externally provided) as patient care costs.  As of late, we
have questioned this with respect to lab costs incurred relative to studies
where the patient/subject might only be providing their blood (for example)
to use for research purposes, but are not directly participating in the
research protocol.  (In other words, they are not receiving any individual
results from the study.)  Is it safe to say that if a patient (or volunteer)
is not receiving a direct benefit from the "routine or ancillary services"
costs being incurred, the cost should not be categorized as "research
patient care"?

2.      Relative to having a negotiated patient care rate, can anyone
provide some guidance on when it applies or, at least, direct us to
additional sources of information or reliable person(s) to contact on the
subject?

3.  For federally funded clinical trials, where the funding agency provides
grant dollars for a portion of the activity and a fixed fee payment for the
patient forms component, obviously for the grant portion we must give the
government our "best price".  (In that situation we use our Medicare rates.)
However, is there any guidance on what rates we charge to the fixed fee
portion?

Thanks in advance to all those who can provide a response!!

Debra K. Hansen
Director of Sponsored Programs and Fiscal Affairs
Marshfield Medical Research and Education Foundation,
a Division of Marshfield Clinic
1000 N Oak Avenue - 1R3
Marshfield, WI   54449
715-387-9130
xxxxxx@mfldclin.edu

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