Debra,

Although I do not know the full details of your situation, I provide my general
responses to your questions
about developing, submitting and negotiating Patient Care rate proposals with
the federal government.

1) The DHHS "Guide for Hospitals" (OASC-3) is the authoritative federal document
for developing
submitting, and negotiating Patient Care (P/C) rate proposals to the federal
government.  It is my understanding that
this is now under revision.  Regrettably, this is currently not available
on-line via a Website but I have copies
that I could send to you.

The "Guide" mandates that such rates basically flow from the hospital/clinic
Medicare Cost Report data, with
some minor adjustments.

2) The NIH Grants Policy Statement (revised 3/2001) includes a helpful section
on Research Patient Care
costs (see page 255).  This includes full Definitions of what is considered P/C
and, just as importantly, what is not
considered P/C.

Also, the NIHGPS provides the criteria for submission and negotiation of P/C
rates.  For example, DHHS Division
of Cost Allocation (DCA) will generally negotiate only with organizations that
are award "direct recipients" of $100,000 or more
in federal research P/C costs.

Below this threshold, organizations may have to negotiate rates with the actual
award "grantees"  (i.e., a university that is the prime
grant recipient).  Please see the "Special Procedures" section (page 258) for
full details.

The NIHGPS is available on-line:
http://grants.nih.gov./grants/policy/nihgps_2001/index.htm

3) Given your organizational location, I assume that your cognizant federal
negotiators are in the Dallas region.  It may
be worth a call to Dallas Branch Chief, Henry Williams (#214-767-3764) to
ascertain your status.

Regards,
Steve

===========================================================

"Hansen, Debra" wrote:

> 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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