Review Cycle: October 1972
#RMOOO AB

RMPS STAFF BRIEFING DOCUMENT
910 APPLICATION

 

Title: New York - New Jersey Transplant Program

Applicant: The ‘Community Blood Council Director of

of Greater New York, Inc. Project: Louis N. Baker, Ph.D.
- : af
Funding Requested: Direct Indirect Total

01: 339,920 39,294 379,214

(02: 288,038 ~ 38,155 . 326,193 ~

03: 177,725 27,270 204,995

Summary:

Applicant proposes a cadaver kidney organ procurement program to be

. developed in the Greater New York Metropolitan area, with full participa-
- tion of NYM/RMP, New Jersey RMP, and Nassau-Suffolk RMP. The program is
an outgrowth of several years' planning by NYM/RMP and with institutions.
and a developmental grant given to the New York Blood Center for the

period July 1, 1971 - December 31, 1972.

Program objectives are: (1) to increase the supply of organs from the
present 50/year to 400/year by the end of the third year; (2) provide. a
coordinating network for organ procurement, preservation, and distribution
among 14 transplant hospitals, 5 organ preservation laboratories, 6 tissue-
typing laboratiories, and other hospitals; (3) establish professional and
public educational programs, (4) develop third-party payment sources and,
(5) develop complementary research programs to be supported by other than
-RMP sources,

The basic proposal complied with the review provisions of the Kidney Disease
Guidelines, but was not fully responsive with regard to funding and cost
elements, development of third-party support, and specification of committed
cooperation, A program assistance visit was arranged and conducted on
September 20 to discuss these factors, A supplement to the proposal was
received on October 5, which proposed a funding period reduced from 5 years
to 3 years, less total program grant cost, and a sharper decrement of RMPS
support. The Supplement also provides a response to other issues raised

by the staff visitors.
TO

FROM

SUBJECT:

. . ~~

MEMOR ANDUM DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

’ ‘ PUBLIC HEALTH SERVICE
HEALTH SERVICES AND MENTAL HEALTH-ADMINISTRATION

Deputy Director, DOD © _ DATE: October 12, 1972

Senior Health Consultant, DPTD

Staff Comments on the 910 Application, | 7
New York - New Jersey Transplant Program ,

Staff review of the original proposal elicited a number of significant
discrepancies with the Kidney Disease Guidelines. While the review
processes were complied with, we observed conflicts with policy stated
and implied in RMPS guidelines. A program assistance visit was arranged
on September 20, and on October 5 a.Supplement to the application was
received as a response to matters discussed at the meeting with staff.
Participants in the meeting are listed in the Supplement.

Major points of discussion at the program assistance meeting included:

1. The proposed 5-year funding period and overall high cost. .

2. Failure to reflect early development of support from third parties.

3, The strength of the commitments to the program by existing organ
procurement groups.

4, Specific budget items such as the cost of organ procurement, the
size of the educational program, and the inclusion of costs items
normally included in overhead.

5. Possible involvement with other organ procurement networks.

6, Involvement of other renal transplant and dialysis activities

in thése regions.

The RMP participants generally accepted the criticisms with good grace,
and expressed willingness to provide more specific information requested,
including a reduction to 3-year RMPS support.

Two items were not resolved to the full satisfaction of all:

a) the cost of donor-organ recovery, which is double the amount

recommended elsewhere; and,
b) the efficacy of substituting educational efforts for direct
Surgeon involvement in developing organ: donation and recovery

sources,
a

Deputy Director, DOD - 910 Application oS Page 2

 

Statements made in the meeting were in direct opposition to previous

experience and expertrenal advice heretofore obtained. As a part of
the discussion of these factors, staff were troubled by the fact that
neither dates nor minutes could be produced regarding meetings of the
Transplant Advisory Committee. .
“The Supplemental document represents a significant realignment by the
applicant, but is not entirely satisfactory to staff in the following
ways:

we

1. The decrement of RMPS support is not as sharp as it should be,
being only 14%.in Year 02 and 46% in Year 03. The ‘statements
in the application may not accurately reflect .the early potential
for third-party support. -.Another New York Region has reported
that Medicaid has already agreed to reimburse for donor organs,
and only the amount of such payments is to be established.
Another eastern RMP has influenced the Hospital Insurance Council
to advise its constituents- of its agreement with the concept of
reimbursement for organ donations. The Blood Center appears
unnecessarily cautious with regard to the need for immediate
intensive efforts to obtain third-party program support.

2. The program sponsors appear to be relying too heavily on educa-
tional activities to increase the supply of organs. Their affir-
mation at the site visit, that the outside renal Consultants
favored educational activities in preference to dedicated surgeon
efforts in organ procurement, is'in contradiction to advice given
heretofore,

3. The Blood Center's interest in ultimately becoming a multi-organ
source is not reflected in its refusal to accept developmental
costs, such as renovations. At the same time, the Center is
apparently asking full first-year support of its tissue-typing
laboratory while it converts from research grants support to a
service facility.

4, The Supplemental proposal has not clarified the intention, stated
at the site visit, to reduce the number of service tissue-typing
laboratories once the Blood Center's laboratory is converted to a
service operation. We are asked to support a 6th tissue-typing
laboratory which has not yet performed service activities, and
with regard to which there is question regarding ultimate accep-~-
tance as a major center by transplanters.

As you know, in later seeking to clarify some of the purported Consultant
advice which appears to contradict previous tranplanter posture, we
encountered potential problems which could affect successful implemen-
tation of this proposal, Perhaps there will be opportunity to discuss
this further in Council toward clarifications acceptable to all involved

parties, - i
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