Federal Register, Volume 59 Issue 173 (Thursday, September 8, 1994)

[Federal Register Volume 59, Number 173 (Thursday, September 8, 1994)]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21993]

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[Federal Register: September 8, 1994]

_______________________________________________________________________

Part II

Department of Health and Human Services

_______________________________________________________________________

Public Health Service

Health Care and Financing Administration

_______________________________________________________________________

42 CFR Parts 121, 405, 482 and 485

Organ Procurement and Transplantation Network; Proposed Rule

Medicare and Medicaid Programs; Organ Procurement Organizations; Final
Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 121

RIN: 0905-AD26

Organ Procurement and Transplantation Network

AGENCY: Public Health Service, DHHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This notice sets forth the Secretary's proposal for rules
governing the operation of the Organ Procurement and Transplantation
Network (OPTN). The proposed rules establish requirements and
procedures for membership in the OPTN, for listing transplant
candidates on a nationwide computer network, for allocating organs, and
for maintaining records and reporting by member Organ Procurement
Organizations (OPOs) and transplant hospitals.

DATES: To be considered, comments must be received by December 7, 1994.
In addition, as indicated in Section G of this Preamble, the Department
has decided to initiate the process of obtaining public comment on the
organ allocation policies of the OPTN. These comments should also be
received by December 7, 1994. Subject to consideration of the comments
submitted, the Department intends to publish final regulations.

ADDRESSES: Comments should be submitted to Ms. Judith B. Braslow,
Director, Division of Organ Transplantation, room 7-18, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:Judith B. Braslow (301) 443-7577.

SUPPLEMENTARY INFORMATION:

I. Background

The OPTN was established under section 372(b)(2) of the PHS Act, as
enacted by the National Organ Transplant Act of 1984 (Pub. L. 98-507),
and amended by Pub. L. 100-607 and Pub. L. 101-616. Section 372
requires the Secretary to provide by contract for the establishment and
operation of the OPTN to:
(A) establish in one location or through regional centers--
(i) a national list of individuals who need organs, and
(ii) a national system, through the use of computers and in
accordance with established medical criteria, to match organs and
individuals included on the list, especially individuals whose immune
system makes it difficult for them to receive organs,
(B) establish membership criteria and medical criteria for
allocating organs and provide to members of the public an opportunity
to comment with respect to such criteria,
(C) maintain a twenty-four-hour telephone service to facilitate
matching organs with individuals included on the list,
(D) assist organ procurement organizations in the nationwide
distribution of organs equitably among transplant patients,
(E) adopt and use standards of quality for the acquisition and
transportation of donated organs, including standards for preventing
the acquisition of organs that are infected with the etiologic agent
for acquired immunodeficiency syndrome,
(F) prepare and distribute, on a regionalized basis (and, to the
extent practicable, among regions on a national basis), samples of
blood sera from individuals who are included on the list and whose
immune system makes it difficult for them to receive organs, in order
to facilitate matching the compatibility of such individuals with organ
donors,
(G) coordinate, as appropriate, the transportation of organs from
organ procurement organizations to transplant centers,
(H) provide information to physicians and other health
professionals regarding organ donation,
(I) collect, analyze, and publish data concerning organ donations
and transplants,
(J) carry out studies and demonstration projects for the purpose of
improving procedures for organ procurement and allocation,
(K) work actively to increase the supply of donated organs, and
(L) submit to the Secretary an annual report containing information
on the comparative costs and patient outcomes at each transplant center
affiliated with the OPTN.
The House Report (H.R. Rep. No. 575, 98th Congress, 1st Session,
1983) which accompanied Public Law 98-507 stated that the Committee
intended that the OPTN be a strong, active national network for
matching donated organs and for making available to OPOs a variety of
services and resources to assist and enhance their operation.
Until the enactment of the Omnibus Budget Reconciliation Act of
1986 (Pub. L. 99-509), membership in the OPTN was voluntary. Section
9318 of Public Law 99-509 added a new section 1138 to the Social
Security Act. Section 1138(a)(1)(B) requires Medicare and Medicaid
participating hospitals that perform organ transplants to be members of
and abide by the rules and requirements of the OPTN. Section
1138(b)(1)(D) requires that for organ procurement costs attributable to
payments to an OPO to be paid by Medicare or Medicaid, the OPO must be
a member of and abide by the rules and requirements of the OPTN.
Although not required by Federal law, other entities (for example,
histocompatibility laboratories) may be members of the OPTN.
Section 102(c) of the Balanced Budget and Emergency Deficit Control
and Reaffirmation Act of 1987 (Pub. L. 100-119) delayed the effective
date of section 1138(a) of the Social Security Act concerning hospitals
from October 1, 1987, to November 21, 1987, and section 4009(g) of the
Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203) further
delayed the effective date of section 1138(b) of the Act concerning
OPOs to April 1, 1988.
The Organ Transplant Amendments of 1988 (Title IV of Pub. L. 100-
607) amended section 372 of the Public Health Service Act to require
that the OPTN establish membership criteria and subject its policies to
public review and comment.
On March 1, 1988 (53 FR 6526), the Department (HHS) published final
rules that included the requirement that hospitals participating in
Medicare and Medicaid which perform transplants and designated OPOs be
members of and abide by the rules and requirements of the OPTN (42 CFR
485.305 and 482.12(c)(5)(ii)) in order to qualify for Medicare or
Medicaid payments.
There has been much discussion between HHS and the United Network
for Organ Sharing (UNOS), the contractor operating the OPTN, concerning
the policies that should constitute a rule or requirement of the
Network and what procedures will be used to determine whether an entity
is a member of the OPTN and, more specifically, the process by which
the Secretary will approve or disapprove actions of the OPTN and
announce these decisions to the public. On December 18, 1989, the
Department published a general notice in the Federal Register (54 FR
51802) announcing its policy regarding this matter. The notice stated
as follows:
In order to be a rule or requirement of the OPTN, and therefore
mandatory or binding on hospitals and OPOs participating in Medicare or
Medicaid, the Secretary must have given formal approval to the rule or
requirement. Approved rules and requirements will be issued in
accordance with the Administrative Procedure Act (APA) (5 U.S.C. 501 et
seq.). If an OPTN rule or requirement would constitute a ``rule''
within the meaning of the APA and is not exempt from the publication
requirement, it will be published in the Federal Register. No hospital
will be considered out of compliance with section 1138(a)(1)(B) of the
Act or the regulations at 42 CFR 482.12(c)(5)(ii), and no OPO will be
considered to be out of compliance with section 1138(b)(1)(D) of the
Act or regulations at 42 CFR 485.305 unless the Secretary has given the
OPTN formal notice approving the decision to exclude the entity from
the OPTN and has also notified the entity in writing.

II. Purpose of the Proposed Rules

In keeping with the policy announced by the Department on December
18, 1989, we are proposing regulations which set a framework for the
operation of the OPTN. The proposed rules provide for Federal oversight
of the processes by which the OPTN allocates organs for
transplantation. They focus the Federal role on ensuring that those
processes are fair and equitable, and provide for public participation.
Under the proposed regulations, the OPTN has responsibility for
developing policies governing organ transplantation, and the day-to-day
operation of the OPTN.
Matters which are covered under existing Federal and State statutes
and rules are not included in the proposed rules. For example, Medicare
transplant hospitals must already comply with Federal statutory
requirements or rules establishing Medicare hospital conditions of
participation (42 CFR Part 482), governing end stage renal disease
(ESRD) facilities (42 CFR Part 405, Subpart U), and Medicare coverage
of heart transplantation (52 FR 10935) and adult liver transplantation
(56 FR 15006). The Department has extensive rules regarding blood (21
CFR Parts 606, 610, and 640). The Department has also published final
rules governing virtually all laboratories operating in interstate
commerce. As discussed below, existing civil rights regulations govern
all of these facilities. Any experimental work regarding
transplantation is subject to HHS rules protecting the human subjects
of research (45 CFR Part 46). Rules establishing conditions for
coverage for OPOs are set forth in 42 CFR Part 485, Subpart B. However,
we request comment on the desirability of adding policies to the body
of HHS regulations governing transplantation. Such proposals would be
most helpful if they refer specifically to proposed provisions to be
added, provide a specific rationale for the suggested addition, and
provide empirical evidence in support of any proposed addition. We
prefer evidence that the policy is not merely desirable, but so
essential as to justify suspending a transplant program's access to
organs for transplantation if not followed.
Set forth below are regulations proposed as rules and requirements
of the OPTN which, if adopted in final form by the Secretary, will
regulate the Organ Procurement and Transplantation Network.

III. Description of the Proposed Rules

In addition to focussing on ensuring public participation in the
process by which organ allocation and other policies are developed, the
proposed rules create an enforceable standard which OPTN member
transplant programs must meet to qualify to receive organs for
transplantation. Where the proposed rules call for review, evaluation,
or appeal actions by the Secretary, decisionmaking will be carried out
by the Health Resources and Services Administration (HRSA), PHS, to
whom authorities under Section 372 of the PHS Act have previously been
delegated. As appropriate, HRSA will consult with interested agencies
in carrying out these responsibilities.

A. Applicability

The proposed rules apply to the operation of the Organ Procurement
and Transplantation Network. In addition, the proposed rules set forth
those requirements of the OPTN with which its member OPOs and
transplant hospitals must comply as a condition of participation in
Medicare and Medicaid (42 CFR 482.12(c)(5)(ii) and 485.305). The rules
do not separately refer to civil rights requirements. However,
participating transplant hospitals and OPOs are already subject to
applicable Federal civil rights requirements and sanctions. Thus, for
example, Title VI of the Civil Rights Act of 1964 (race and national
origin discrimination) and Section 504 of the Rehabilitation Act of
1973 (disability discrimination) apply to any program or activity
receiving Federal financial assistance. Other civil rights laws also
apply to recipients of Federal financial assistance. For example, the
Age Discrimination Act of 1975 prohibits age discrimination by
recipients of Federal assistance; Title IX of the Education Amendments
of 1972 prohibits sex discrimination in education programs receiving
Federal assistance.

B. Membership

The proposed rules support broad-based membership. In accordance
with section 372 of the Public Health Service Act, the proposed rules
allow organizations, institutions, and individuals to become members of
the OPTN.
Under proposed Sec. 121.3(c)(1), OPOs designated by HHS under
section 1138(b) of the Social Security Act are required to be admitted
as members of the OPTN. Similarly, under proposed Sec. 121.3(c)(2), all
hospitals which are subject to section 1138 of the Social Security Act
because they perform transplants will be admitted as members of the
OPTN. OPOs will be required to abide by the rules and requirements of
the OPTN in order to be reimbursed under Medicare or Medicaid for
organs which they procure. Similarly, transplant hospitals subject to
section 1138 must abide by the rules and requirements of the OPTN as a
condition of their continued participation in Medicare and Medicaid.
Failure to abide by these rules may subject them to termination from
Medicare and Medicaid, unless they no longer provide transplantation
services.
With reference to membership of newly designated OPOs, the
Department anticipates no administrative conflict between these
proposed rules and the requirement for designation by HHS under section
1138(b) of the Social Security Act which calls for membership in the
OPTN. Since the purpose of this requirement of section 1138(b) is to
ensure that OPOs are required to follow OPTN rules, OPOs designated by
HHS are automatically made members of the OPTN.
The proposed rules require that other institutions, organizations,
and individuals that wish to become members demonstrate an ongoing
interest in the field of organ transplantation. The Department
encourages participation of transplant recipients and donor families in
the deliberations of the OPTN, and it is our intent that membership be
broadly based to invite such participation. Under proposed
Sec. 121.3(d), the OPTN will review and make decisions on applications
for membership. Applicants rejected for membership may appeal to the
Secretary. The Department solicits public reaction to the idea of
expanding the membership base of the OPTN, and to suggestions on how
this can be accomplished.
Proposed Sec. 121.3(a) provides for the establishment of a Board of
Directors to develop general policies, procedures, and issuances;
medical criteria and related policies for the fair and equitable
allocation of human donor organs; policies consistent with
recommendations of the Centers for Disease Control and Prevention to
prevent the spread of infectious diseases; and standards for the
training and experience of transplant surgeons and physicians. See the
discussion at H. below. The proposed rules also require the OPTN to
provide to the Secretary copies of any policies, procedures, and
issuances as they are adopted, and to make them available to the public
upon request. The Secretary will periodically publish lists of these
documents in the Federal Register.
To ensure appropriate representation, the proposed rules require
that the Board include: two members each from, and elected by, the
association representing transplant coordinators, the association
representing organ procurement organizations, and the association
representing histocompatibility experts; at least two representatives
each, elected by the OPTN membership, from the following categories:
transplant surgeons, transplant physicians, representatives of
transplant hospitals, voluntary health organizations, patient advocacy
groups and the general public; and one representative elected by the
members from each region of the OPTN. At present, the OPTN has, at its
discretion, established 11 regions. Therefore, if the current regional
structure were in place under the proposed rules, the Board of
Directors would have eleven regional representatives.
Board members would serve two-year terms, and would be required to
elect an Executive Committee from the membership of the Board, and to
establish other committees whose chairpersons shall be selected to
ensure continuity in leadership. In addition, the proposed rules
require that not more than 50 percent of the Board of Directors and the
Executive Committee be surgeons and physicians directly involved in
organ procurement and transplantation. Proposed Sec. 121.3(a) also
requires that the Board have a diverse membership, including minority
and gender representation reflecting the diversity of the population of
organ donors and recipients served by the OPTN. The Department requests
comment on the composition of the Board of Directors and the method by
which the Board and Executive Committee are elected. In addition, the
Department seeks comment on the best way to ensure ethnic and racial
diversity.

C. Listing Requirements

The proposed rules implement the statutory requirement for a
national system to match donor organs and individual transplant
candidates, and contain a number of specific requirements with respect
to the listing of transplant candidates. Proposed Sec. 121.4(a)(2)
requires that transplant hospitals list all transplant candidates on
the national list as soon as they are determined to be candidates for
transplantation. Moreover, the transplant program with which the listed
transplant candidate is associated must, according to proposed
Sec. 121.4(a)(1), be approved for allocation of organs in accordance
with proposed Sec. 121.8. See the discussion at H. below. There were
27,147 new patients listed in 1993 compared with 20,764 in 1990.
Proposed Sec. 121.4(a)(3) authorizes the OPTN to collect
registration fees for each transplant candidate listed by a transplant
hospital on the national list. The amount of the fee may be determined
by the OPTN subject to review by the Secretary. Payment for patient
registration fees is received from transplant hospitals on behalf of
their patients. The fees, which are generally reimbursed by third-party
and other payors, principally Medicare or Medicaid, are necessary to
support OPTN transplant candidate registration and donor/recipient
matching activities beyond the direct Federal funding available for the
OPTN contract.
Proposed Sec. 121.4(b) requires members that procure organs to
provide to the OPTN timely information on each organ procured. The
Department has included this requirement to convey the importance of
keeping the computer match program up-to-date. See the discussion at E.
below. In 1993, there were 14,701 organs donated and transplanted from
4,860 cadaveric donors, an average of three organs per donor.
It should also be pointed out that nothing in the proposed rules
prohibits patients from being listed by more than one transplant
hospital. Three percent of waiting list patients are listed at two or
more centers. The proposed rules are consistent with the current
voluntary policy which permits transplant candidates to appear on more
than one local list. See the discussion at G. below. The public is
invited to comment on this policy.
An issue related to patient listing concerns the apparent disparity
in kidney transplantation between blacks and whites. There has been
significant research exploring this question. The most recent study,
sponsored by the Department of Health and Human Services and conducted
by the RAND/UCLA Center for Policy Research in Health Care Financing,
examined a number of issues related to access, including cadaveric
kidney procurement, distribution, and allocation of organs by OPOs. The
study team used data from seven large OPOs, the OPTN, and the ESRD
program of the Health Care Financing Administration.
That work (Joel D. Kallich, et al., ``Access to Cadaveric Kidney
Transplantation.'' RAND, 1993, pp. 59-61) concludes:

``* * * that blacks experience problems getting on kidney
transplant waiting lists maintained by transplant centers across the
country. Once on a list, however, the difference in waiting times to
transplant between blacks and whites appears to be the result of
biologic differences between the races.
``Lower rates of access to the waiting lists are not entirely
explained by currently available data on medical condition of the
ESRD patient (age, hospitalizations, and cause of renal failure) or
regional differences. Medical variables account for some
differences, but not all of the racial disparity in access to
transplant waiting lists.''
``In our examination of the hazards ratio of getting on a
waiting list once an individual has entered Medicare's ESRD program,
we found disparities in access to the UNOS waiting list. Again,
available medical/biologic variables do not explain much of the
difference between the races.''
``We do not have any evidence that the differences between the
races that we found is due to conscious or unconscious bias on the
part of health care professionals. Moreover, it is not surprising
that we have found that blacks are having access problems in regard
to kidney transplantation. Blacks in America have a history of
suffering worse health care outcomes and having greater problems in
gaining access to the health care system than white Americans * * *.
Yet kidney transplantation causes special concern about issues of
fairness, because of federal entitlement to medical care services
for all persons with ESRD, * * *''

The Department, too, believes that federal entitlement to ESRD-related
medical services necessitates careful exploration of the observed
disparity between blacks and whites in access to the kidney
transplantation waiting list, especially those which may be without
medical or biological foundation. Consequently, the Department invites
comment and is especially interested in data which may illuminate and
assist further in examination of the movement of ESRD patients to the
waiting lists for kidney transplantation.

D. Organ Procurement

Proposed Sec. 121.5 is intended to establish minimum requirements
to improve the outcome of transplantation and minimize the potential
for wastage of organs. These proposed requirements apply only to
cadaveric organs and not to organs (such as kidneys and liver lobes)
from living donors.
Proposed Sec. 121.5(a) requires that OPTN members that procure
organs screen donors, in accordance with OPTN policies, to determine
any contraindications for donor acceptance. Under policies now
voluntarily followed by OPTN members, screening is done for HIV-1, HIV-
2, HTLV I/II, hepatitis B, the presence of metastasizing malignancies,
including tumors of the liver, sepsis, or evidence that the donor
received human pituitary derived growth hormone or dura mater products.
The latter are included because of the potential for transmitting
Creutzfeldt-Jakob Disease (CJD).
Proposed Sec. 121.5(b), in keeping with sections 371(b) and 372(b)
of the PHS Act, specifies that members are prohibited from procuring
organs from donors known to have Human Immunodeficiency Virus (HIV-1 or
HIV-2).
Screening potential donors for HIV infection has been conducted
since 1985, when tests for HIV antibody became available. Although this
screening has markedly reduced the potential for transmission of HIV
through organ donation, the possibility--however remote--still exists
because antibodies may not be detected until three to six months after
infection. Following a recent finding of HIV infection among recipients
of organs and tissue from a donor who tested negative for HIV
infection, the Centers for Disease Control and Prevention is developing
recommendations on HIV testing of transplant recipients. Proposed
Sec. 121.3(a)(6)(i)(C) requires the OPTN Board of Directors to develop
policies consistent with recommendations of the Centers for Disease
Control and Prevention related to the control of infectious diseases,
particularly HIV.
Under proposed Sec. 121.5(c), transplant hospitals may establish
donor acceptance criteria. If they do so, the proposed rules require
the hospitals to provide the criteria to OPOs with which they have
agreements and to the OPTN. Donor acceptance criteria enable the OPO
and the OPTN to make speedy determinations about where to offer an
organ. For example, if a transplant hospital specifies the age range of
donors from which it would accept organs for transplant, the OPTN's
computer match program would automatically exclude patients at that
transplant hospital from the list of potential recipients of an organ
whose donor exceeded that age range. Thus, the potential for delay and
organ wastage would be minimized.

Number and Percent of Donors 55 to 64 and 65 and over--1991, 1992, 1993
----------------------------------------------------------------------------------------------------------------
1991 1992 1993
-----------------------------------------------------------------------------------------------
No. Percent No. Percent No. Percent
----------------------------------------------------------------------------------------------------------------
55 to 64........ 377 8.3 449 9.9 497 10.3
65 and over..... 127 2.8 175 3.9 211 4.4
----------------------------------------------------------------------------------------------------------------

E. Identification of Organ Recipient

Proposed Sec. 121.6 establishes the regulatory framework within
which operate the various cadaveric organ allocation schemes developed
under proposed Sec. 121.7. See the discussion at F. below.
Under proposed Sec. 121.6(b), an OPTN member which procures an
organ is required to run the computer match program to identify and
rank potential recipients of the organ. Ranking would be determined in
accordance with the allocation policies developed by the OPTN under
proposed Sec. 121.7.
Proposed Sec. 121.6(a) also provides that organs which do not meet
a transplant hospital's donor acceptance criteria will not be offered
to transplant candidates of that hospital. Thus, a transplant candidate
will not appear on a listing of potential recipients for a donor organ
which does not meet the acceptance criteria of the candidate's
hospital.
Under proposed Sec. 121.6(b), organs must be offered to potential
recipients in rank order, and only to potential recipients listed with
transplant hospitals having transplant programs of the same type as the
organ procured and which meet the requirements of proposed Sec. 121.8.
For all organ offers, proposed Sec. 121.6(b)(4) requires transplant
hospitals to accept or reject the offer within a time limit established
by the OPTN, provided sufficient information is given to enable a
decision to be made. The time limit, which is presently one hour, is
established to assure prompt consideration of an offer and the ability
to make an offer to subsequently ranked candidates before the organ
becomes too old to be transplanted.
Under proposed Sec. 121.6(c), the OPTN member that procures a
donated organ is responsible for arranging for its transportation to
the transplant hospital, and for ensuring that it is accompanied by
appropriate documentation and is packaged properly. The Department has
not included in these proposed rules detailed requirements for
documentation and packaging, because such standards have been well-
established in medical practice and are included in the OPTN policies.
The Department believes that it is unnecessary to codify them into
Federal rules. In addition, information about state-of-the-art practice
is available from the OPTN. We expect that OPTN members will continue
to follow accepted medical practices.
In the event that a transplant hospital decides not to use the
organ it receives for the potential recipient for whom it was offered,
proposed Sec. 121.6(d) requires the transplant hospital to offer the
organ to another potential recipient in accordance with proposed
Sec. 121.6(b).
Proposed Sec. 121.6(e) in effect suspends the allocation
requirements of proposed Sec. 121.6 when circumstances arise which
would otherwise cause an organ to be wasted. It requires that an OPO or
transplant hospital report to the OPTN, within time limits established
by the OPTN, any situation in which it did not follow these
requirements, and the precise circumstances surrounding the failure to
follow the allocation requirements. The Department believes that this
provision provides OPOs and transplant hospitals with the regulatory
flexibility needed to ensure that organ wastage is minimized.

F. Allocation of Organs

Proposed Sec. 121.7 provides that the OPTN Board of Directors shall
develop policies for allocating organs for transplantation. It requires
that such policies be patient-based and take into account established
medical criteria for transplantation, the length of time potential
recipients have been on the national list, and potential recipients
whose immune system makes it difficult for them to receive organs,
while minimizing wastage of the scarce supply of human organs for
transplantation and improving the outcomes of transplantation. These
proposed rules do not apply to organs from living donors, either
related or unrelated, and proposed Sec. 121.7(d) explicitly permits the
allocation of cadaveric organs to individual recipients named by those
authorized to make the donation.
Proposed Sec. 121.7(b) requires that the Board of Directors provide
opportunity for the membership of the OPTN to comment on proposed
policies. Concurrently, the Secretary would publish the proposed
policies or a notice about the proposed policies in the Federal
Register to give the public an opportunity to comment. Further, the
proposed rule provides that the Secretary shall review final allocation
policies and provide comments and/or objections. The OPTN must consider
the Secretary's comments before the policies are finalized. If the
Secretary objects to a policy, the OPTN may be directed to revise the
policy consistent with the Secretary's direction. OPTN members,
individuals and entities objecting to final policies may appeal to the
Secretary within 30 days of their adoption.
The Department recognizes that the present organ allocation
policies, which will be the subject of these public comment procedures,
raise difficult issues. For example, efforts to promote service to the
sickest patients first versus those likely to survive the longest may
conflict. Similarly, some policies intended to maximize transplant
outcomes and based on sound scientific data may have adverse
implications for one ethnic group in particular, or for residents of
particular geographic areas. The Department is committed to a full
public debate on these and related issues that arise in the context of
organ allocation policies. As set forth below, the Department is
circulating the present OPTN policies for the purpose of public debate,
but wishes to make clear that publication of the policies does not
indicate agreement or disagreement with them in their present form. The
process is being initiated to allow the earliest possible adoption of
final allocation policies, and the Department reserves its judgment on
the wisdom of the present OPTN policies until the public comments can
be considered.
Under the existing organ procurement and transplantation system,
members have followed organ-specific allocation policies developed by
UNOS. For the purposes of this rulemaking, the Department considers
these policies to be proposed policies and intends for the public to
have an opportunity to comment on them. However, to avoid disruption in
the allocation of organs, the Department expects the OPTN to continue
to utilize, and OPOs and transplant hospitals to follow, these policies
during the review and comment process.
So that this proposed rule may be considered in the context of
these allocation policies, following is general information about them.

G. Existing Organ Allocation Policies

The organ allocation policies now being followed by transplant
hospitals and OPOs were developed by UNOS through special committees
established by the OPTN. In their proposed form, these policies were
circulated to a wide variety of groups and individuals interested in
the field of transplantation, and their comments were considered before
the policies were finalized. Taken together, these policies comprise a
national system of organ allocation which has been in operation, albeit
frequently modified, since establishment of the OPTN in 1984. Following
is a table which shows, by organ, the number of transplants performed
in 1990 and 1993 the number of people on the waiting list at the end of
that year, and the 2 year graft survival by organ for transplants
performed between October 1, 1987 and December 31, 1991.

--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of transplants No. of patients on wait list\1\ as of 2 year graft
---------------------------------------- December 31, survival for
Organ ---------------------------------------- transplants
1990 1993 between 10/1/87
1990 1993 and 12/31/91
--------------------------------------------------------------------------------------------------------------------------------------------------------
Kidney.............................................. 9,886 10,265 17,883 25,069 72.8%
Liver............................................... 2,682 3,442 1,237 2,982 62.3%
Heart............................................... 2,107 2,299 1,788 2,833 76.2%
Pancreas............................................ 537 773 473 1,110 65.2%
Lung................................................ 202 664 308 1,255 53.1%
Heart-lung.......................................... 52 60 225 203 47.7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\Because of multiple listing, the number of patients on the wait list is higher than the actual number of individual patients waiting for a
transplant. However, the number on the wait list is smaller than the total number of patients likely to benefit from transplantation because many do
not get listed due to inability to pay, fear of surgery, etc.

The allocation policies call for matching donated cadaveric organs
with potential transplant recipients registered on a national,
computerized list of transplant candidates. Matching organs to
potential recipients is based on medical criteria such as blood type,
histocompatibility, sensitivity of the patient to transplantation
(panel reactive antibody), and degree of urgency. Other criteria taken
into account are time on the waiting list and geography. Generally,
donated organs are allocated first to medically qualified candidates
locally, then regionally, and then nationally. The policy effective in
July 1993 defines local as the OPO service area in most cases.
Potential recipients are identified by generating local and regional
lists of names from the national list of transplant candidates.
Following is a table showing the range of median waiting times among
OPOs by region.

Range of Median Waiting Times by Days Among OPOs in Region
[1992]
----------------------------------------------------------------------------------------------------------------
Region Kidney Liver Heart Pancreas
----------------------------------------------------------------------------------------------------------------
1............................. 505-725 91-375 168-265 (\2\)
2............................. 397-772 108-209 68-540 (\2\)
3............................. 125-826 20-78 72-265 (\2\)
4............................. 223-523 70-105 55-325 (\2\)
5............................. 130-786 18-197 130-355 (\2\)
6............................. 94-533 \1\56 56-182 (\2\)
7............................. 448-695 31-256 226-641 (\2\)
8............................. 271-539 26-121 92-381 (\2\)
9............................. 213-698 279-443 255-268 (\2\)
10............................ 185-348 33-194 89-591 (\2\)
11............................ 151-723 30-276 111-767 (\2\)

United States................. 94-826 18-443 55-767 (\2\)
----------------------------------------------------------------------------------------------------------------
\1\Two OPOs in Region 6 that contain liver transplant centers; both with waiting times of 56 days.
\2\Insufficient data because of small number of cases.

Potential recipients of hearts, heart-lung-combinations, and lungs
are ranked according to medical urgency, time on the national list, and
logistics. For kidneys, livers, and pancreata, potential recipients are
ranked, using a point system, according to point values for the
criteria established in each organ allocation policy, To calculate the
number of points for time, for example, if there are 75 potential
recipients in blood group O on the list for kidneys, the person with
the longest time would have a number of points equal to 75 divided by
75, times 1; or 1 point. If a potential recipient had a position number
of 60 on the list of 75 potential recipients in blood group O, that
person would have a number of points equal to 60 divided by 75, times
1; or 0.8 points. The policy also awards 0.5 additional points for each
year above one year on the list. The kidney allocation policy also
establishes point values for the quality of antigen match emphasizing
the lack of mismatches, and degree of panel reactive antibody. It also
specifies that potential recipients five years old or younger receive
an additional two points, and that potential recipients who are six
through ten years old receive an additional one point. Additional
points are awarded to children because they generally do not do well on
dialysis, the alternative to kidney transplantation.
The current policies also permit variances to the point system and
the establishment of alternative local units for distributing organs,
subject to the approval of the OPTN. For example, they permit
interregional and intraregional groups to develop organ sharing
arrangements, allow transplant hospitals and OPOs to assign different
point values to the organ allocation criteria, and permit OPOs to
institute alternative arrangements to distribute hearts and heart-lung
combinations within the boundaries of the OPO. Other existing policies
require an OPO receiving a six antigen matched kidney to ``pay back'' a
kidney to the OPTN and, in the case of simultaneous kidney-pancreas
transplantation, require only one of the kidneys procured to be offered
for a six antigen matched recipient. The Department requests comment on
the use of variances and alternative local units by the OPTN and
whether they should be permitted to continue.
The Department recognizes that there is significant public interest
in the present organ allocation policies of the OPTN. In order to
expedite the process of the public comment on those policies, the
Department has decided to initiate the process described in the
proposed rule set forth below. Accordingly, anyone interested in
commenting on the present allocation policies may obtain a copy by
writing to the United Network for Organ Sharing, 1100 Boulders Parkway,
suite 500, Post Office Box 13770, Richmond VA 23225-8770.
The Department asks that anyone who wishes to comment on the
present organ allocation policies submit written comments to Ms. Judith
B. Braslow, Director, Division of Organ Transplantation, room 7-18,
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, by December
7, 1994. In addition, a copy should be submitted at the same time to
the United Network for Organ Sharing.
Depending on the public comments submitted in response to this
proposed rule, the Department may revise the process of comment on the
allocation policies. However, in anticipation that the final rule will
be substantially the same in this regard as the proposed rule, the
Department felt it wise to expedite the comment process by announcing
the availability of the present organ allocation policies
simultaneously with the publication of this proposed rule. The final
analysis of comments on the present allocation policies will, of
course, await the publication of the final rule.
In addition, the Department requests comment specifically on moving
toward single regional listings of potential recipients drawn from the
national list for the purpose of allocating organs, and whether the use
of regional listings is feasible and would lead to a fairer and more
equitable allocation system.
In seeking comments on an allocation system, the Department
stresses that it is not committed to those policies presently in place.
The public is invited to propose any alternative methods for allocating
organs, including systems which may differ markedly from the current
allocation schemes. Among the features which may be considered are a
framework which is national in scope and at the same time patient
focused; consideration of equitable distribution of organs; the extent
to which the allocation system will foster improvements in graft and
patient survival; and the extent to which a patient may select among
transplant programs once having been placed on the transplantation
waiting list. The Department, of course, is committed to disclosure to
patients and physicians of data on transplant program performance and
any available cost information pertinent to transplant programs
regardless of the allocation policies in place.
The Department will use the comprehensive transplantation data
system in reviewing the data presented and the questions raised by
commentors on the allocation policies. The data shown below is an
illustration of the information available on organ allocation.
Transplant program performance and volume information is also
available.

Allocation of Organs--1991, 1992, 1993
[Percentage]
------------------------------------------------------------------------
Kidneys Hearts Livers
------------------------------------------------------------------------
1991:
Transplanted locally....................... 70.6 65.9 48.5
Shared within region....................... 11.2 17.2 30.1
Shared outside region...................... 18.2 16.4 20.3
1992:
Transplanted locally....................... 73.6 70.9 55.6
Shared within region....................... 9.8 15.0 28.3
Shared outside region...................... 16.5 14.5 15.6
1993:
Transplanted locally....................... 74.7 70.6 56.8
Shared within region....................... 9.2 14.7 27.7
Shared outside region...................... 15.7 14.0 14.6
------------------------------------------------------------------------

Heart and Liver One-Year Graft Survival Rate by Patient Description at
Time of Transplant
[Percentage]
------------------------------------------------------------------------
Patient description Heart Liver
------------------------------------------------------------------------
Working/attending school full time...................... 93.6 79.1
Working/attending school part time...................... 84.4 75.2
Homebound/failing to thrive............................. 83.5 74.4
Hospitalized............................................ 81.0 68.1
In intensive care....................................... 82.4 64.0
On life support......................................... 72.8 47.5
------------------------------------------------------------------------

H. Designated Transplant Program Requirements

The Department believes that, in enacting the National Organ
Transplantation Act, the Congress intended that establishment of the
OPTN would ensure that human organ transplantation is conducted in
facilities properly equipped and staffed to carry out these complex
procedures.

Number of OPTN Approved Centers, 1993
----------------------------------------------------------------------------------------------------------------
KIdney Liver Pancreas Heart Heart-lung Lung
----------------------------------------------------------------------------------------------------------------
246.............. 109 112 164 89 76
----------------------------------------------------------------------------------------------------------------

The Department also believes that, although its regulations should
be minimal with as much flexibility as possible, it has a statutory
responsibility to ensure that the rule maintain, and indeed promote,
high quality care. For example, the Department's rules published on
April 12, 1991, to include coverage of liver transplants under Medicare
are explicit in stating that a goal of the criteria for facilities to
qualify for reimbursement is to maintain the quality of services. (56
FR 15009).
These proposed rules complement the criteria established for
coverage of organ transplantation under Medicare. The Medicare
requirements place emphasis on the facilities in which transplantation
is performed; that is, criteria are established for facility experience
in terms of numbers of transplants performed and survival rates. Thus,
for example, as of November 1993 only 33 of the existing 109 liver
transplant programs in the United States qualify for Medicare
reimbursement; 49 of the liver transplant programs applied.
Complementing the Medicare criteria, the proposed OPTN transplant
program requirements provide that transplant programs which meet the
Medicare requirements are automatically qualified to receive organs for
transplantation. For those which do not, the proposed rules set out
service and support requirements which are similar to those required
under Medicare. However, because new transplant programs do not yet
have the transplant experience and survival rates that are needed for
Medicare reimbursement, the proposed OPTN rules include requirements to
be established by the OPTN Board of Directors for the education and
training of transplant surgeons and physicians, thus ensuring the
quality of care in transplant programs which are not yet approved for
Medicare reimbursement.
In developing this proposed rule, the Department considered
allowing all Medicare participating hospitals which performed
transplants (regardless of their qualification for Medicare
reimbursement for transplantation) to be eligible to receive organs for
transplantation without having to meet additional criteria. The
Department rejected this alternative for the same reason it rejected a
similar alternative regarding Medicare coverage of heart and liver
transplants; that it would permit uncontrolled proliferation of
transplant facilities, raising all the concomitant questions about the
quality of services, given the limited availability of donor organs and
experienced teams. (56 FR 15018). Under this option to impose no
facility standards on hospitals beyond those already required of them
through their participation in Medicare and Medicaid, all transplant
hospitals which have a provider agreement under Medicare or which
participate in Medicaid would automatically be approved (assuming that
they met the remainder of the regulation's requirements) to receive
organs through the OPTN. The assumption underlying this option is that
Federal regulation in this area should focus only on a national system
for matching organs and for allocating them equitably, rather than on
standards for conducting transplantation. It also takes the position
that, although there is a theoretical argument that equitable
allocation could be harmed if transplantation itself were not regulated
to prevent organ wastage, such Federal regulation must be premised on
the existence of evidence that significant numbers of organs are
unnecessarily wasted because of the lack of Federally mandated
standards. We invite comment on this option, and specifically request
that commenters provide evidence in support of their position.
Another alternative was to add volume and quality minimums (e.g.,
75 percent success rate on more than 20 procedures a year) which would
exclude hospitals which perform at lower levels. For example, a mere
showing that the average success rate of hospitals meeting a certain
volume level or other standard is several percentage points higher than
the average success rate of other hospitals would not, in our view, be
a sufficient basis for denying other hospitals access to organs. Both
the absolute difference and the standard error of such estimates would
have to allow a high level of certainty that a particular standard
would reduce wastage of many organs and would not exclude meritorious
hospitals that handle sicker than average patients. Furthermore, no
such standard should be adopted if its effect were to exclude hospitals
from newly entering the field of transplantation.
We are reviewing hospital-specific data collected through the
Scientific Registry, a repository of data on transplant recipients that
is operated under contract with the Department, and may identify
patterns which support establishing such a standard. One factor that
patients consider in selecting a transplant center is the annual number
of transplants performed there. The data show that for kidney
transplantation, the risk of graft failure within one year after
transplant is about the same across centers regardless of the number of
transplants performed. Liver transplants at centers doing fewer than 6
transplants were 2.8 times more likely to fail within the first year
than were transplants at centers doing 32-66 transplants. Heart
transplants at centers doing fewer than 9 transplants were 3.5 times
more likely to fail within the first year than were transplants at
centers performing 26 to 45 transplants. The best results for pancreas
transplants appeared to be at centers that performed more than 10
transplants. We will consider suggestions, and will consider proposing
a standard if it is supportable scientifically and sound from a
regulatory standpoint. Any commenters proposing such standards should
provide empirical data, if possible, on the extent of the problem and
on likely improvement.
Another approach was to base the OPTN regulatory criteria on the
standards for Medicare coverage (i.e., eligibility for reimbursement)
of heart and adult liver transplants, or to require compliance with the
many Medicare and Medicaid regulatory provisions directed at or
affecting transplantation (e.g., the social services or laboratory
requirements in the end stage renal disease supplier conditions of
coverage--42 CFR Part 405, Subpart U). The Department believes that
this approach would create a number of problems, including the creation
of unnecessary, duplicative standards and the potential for conflicts
in enforcement where the standards are slightly different.
Nevertheless, we invite comment on this approach and any variations.
Commenters advocating any approach to regulating transplantation
should specify the precise benefits expected and their likely empirical
magnitude, address whether these benefits will be significant in
furthering the purposes of the organ transplantation provisions of the
Public Health Service and Social Security Acts, and discuss whether
other alternatives inside or outside the scope of this proposed
regulation (e.g., efforts to increase organ retrieval or increased
reliance on antigen matching in allocation priorities) might better
achieve these benefits.
The ``User's Guide'' accompanying the 1991 Report of Center-
Specific Graft and Patient Survival Rates notes a number of factors
patients should take into consideration in selecting a transplant
center. Some of the most important factors are:
The graft and patient survival rates of the particular
program.
The experience, training and education of the transplant
team and the medical and nursing care available throughout the process
from candidate evaluation through transplantation and follow-up.
The cost of the transplant procedure, physician services,
hospitalization and medications.
The location of the transplant program and how close it is
to the patient's home and how easily the patient can reach it.
The friends and family available to the patient for
assistance before, during and after the transplant.
The support facilities of the transplant center.
We are soliciting comments on how the current OPTN policies or
other alternative allocation systems would maximize a patient's ability
to choose among transplant centers using the above factors.
In addition, the Department is concerned about the regulation of
organ transplantation in light of health care reform with respect to
issues of equity, access, and cost. The Department solicits comments on
the effect of alternative allocation policies on these issues.

I. Review, Evaluation, and Appeals

To determine compliance with the rules and requirements of the
OPTN, under proposed Sec. 121.9(a) the Secretary or her/his designee
may conduct reviews and evaluate the activities of member OPOs and
transplant hospitals. Proposed Sec. 121.9(b) requires the OPTN to
develop plans and procedures, subject to approval by the Secretary, for
reviewing membership applications from OPOs and transplant hospitals,
and for conducting ongoing reviews and evaluations of member OPOs and
transplant hospitals. The purpose of these reviews and evaluations is
to monitor compliance with the regulations and to conduct such studies
as the Secretary deems necessary. The Secretary may, under proposed
Sec. 121.9(c), suspend a transplant program's eligibility to receive
organs for transplantation if, upon consideration of recommendations
based on reviews or evaluations by the OPTN, the Secretary determines
that the entity has failed to comply with these regulations. Moreover,
the Secretary may decide that, by virtue of section 1138, an OPO is no
longer eligible for reimbursement under Medicare and Medicaid.
Proposed Sec. 121.10(a) provides that any individual or entity may
appeal any policy, procedure, or issuance of the OPTN to the Secretary.
The Secretary will solicit the comments of the OPTN on the appeal and
when warranted will take appropriate action to resolve it. The
Secretary intends that such appeals will be filed only when the
enforcement of the policies at issue implicates an important public
policy or where there is a potential for some penalty to be imposed
either by the OPTN or the Secretary. Proposed Sec. 121.10(b) provides
that the Secretary may object to any policy, procedure, or issuance of
the OPTN, and that the OPTN may be directed to revise the item
consistent with the Secretary's direction.

J. Record Maintenance and Reporting

The record maintenance and reporting requirements of the proposed
rules are limited to the OPTN itself, and to OPOs and transplant
hospitals which are members of the OPTN. The Department's policy is to
assure that transplantation data collected on its behalf are readily
available for scientific and evaluative analysis, and that the OPTN
provides the data to the public, subject to Privacy Act restrictions.
Under proposed Sec. 121.11(a), records are to be maintained and
made available consistent with applicable limitations based on personal
privacy.
Proposed Sec. 121.11(a)(1) requires the OPTN to operate an
automated system for managing information about organ transplant
candidates, recipients, and donors, including a computerized waiting
list, in accordance with the listing requirements of proposed
Sec. 121.4. The OPTN shall maintain patient records in association with
the list. Proposed Sec. 121.11(a)(2) requires OPOs and transplant
hospitals to maintain and make available to the Secretary and
Comptroller General, or their designees, records on patients and donors
for which they are responsible.
Under the reporting requirements of proposed Sec. 121.11(b)(2),
OPOs and transplant hospitals which are members of the OPTN must
provide to the OPTN information about transplantation candidates,
recipients, and donors for which they are responsible. Such information
includes patient and donor identification, medical data necessary for
operating the computer match system, and post-transplant information
about graft survival.
The OPTN is required by proposed Sec. 121.11(b)(1) to report to the
Secretary at least annually the information that the Department
believes is needed to assess the effectiveness of the Nation's organ
donation, procurement, and transplantation system. This provision also
requires the OPTN to report data on transplant candidates and
recipients to the Scientific Registry.

IV. Data Availability

Throughout this Preamble the Department has presented data to
augment the description of the organ transplantation system. Commentors
have been asked to support their comments with pertinent data where
appropriate. In particular, we request that comments on the system for
organ allocation (see sections F and G) be supported by information
which clearly demonstrates advantages derived from the alternative
methods proposed. The Department expects to use data as well in
evaluating the potential effects of proposed changes in organ
allocation. There is considerable information in the literature about
the clinical issues in transplantation, specifically those factors
which affect survival of the transplanted organs and their recipients.
Examples of the kinds of data which may be useful in performing these
analyses are displayed below:

BILLING CODE 4160-15-M

TP08SE94.000

TP08SE94.001

TP08SE94.002

TP08SE94.003

BILLING CODE 4160-15-C
The above charts show the variation in median waiting times, wait list
mortality, and patient status at time of transplant for various organs
within OPTN regions. (There is no patient status data at time of
transplant for kidney transplant patients).
In preparing their responses, commenters may wish to refer to the
following:

``The 1991 Report of Center-Specific Graft and Patient Survival
Rates,'' and
``The 1993 Annual Report of the U.S. Scientific Registry of
Transplant Recipients and the Organ Procurement and Transplantation
Network.''

Both of these documents are available from the United Network for Organ
Sharing, 1100 Boulders Parkway, suite 500, Post Office Box 13770,
Richmond, VA 23225-8770.

V. Economic Impact

Executive Order 12866 requires that all regulations reflect
consideration of alternatives, of costs, of benefits, of incentives, of
equity, and of available information. Regulations must meet certain
standards, such as avoiding unnecessary burden. Regulations which are
``significant'' because of cost, adverse effects on the economy,
inconsistency with other agency actions, effects on the budget, or
novel legal or policy issues, require special analysis. The Regulatory
Flexibility Act requires that we analyze regulatory proposals to
determine whether they create a significant impact on a substantial
number of small entities (for purposes of the Act, all hospitals and
all OPOs are categorized by HHS as small entities).
In part, because of the procedural emphasis of this proposal, it is
premature to analyze the costs and health benefits of regulatory
alternatives as is ordinarily required by Executive Order No. 12866.
For example, per-patient data currently available show that the
government's annual cost for renal dialysis is $40,000. The cost for a
kidney transplant is $87,000. Because of post-transplant costs, it is
not until the third year after dialysis that a successful kidney
transplant becomes more cost effective than dialysis. This analysis is
limited to costs and does not include consideration of nonmonetary
benefits to the patient or society as a whole.
To aid the policy discussion that will follow this Notice the
Department will, to the maximum extent possible, provide comparative
analyses on a range of options it considered, including the existing
OPTN policies. These options will be based on comments received.

VI. Paperwork Reduction Act of 1980

This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1980. Proposed Sec. 121.11(a)(2)
requires OPOs and transplant hospitals which are members of the OPTN to
maintain records on organ donors and transplant patients, and proposed
Sec. 121.11(b)(2) requires them to report to the OPTN information based
on those records. The title, description, and respondent description of
the information collection are shown below with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
the collection of information.
Title: Organ Procurement and Transplantation Network.
Description: Information will be collected from transplant
hospitals and organ procurement organizations for the purpose of
matching donor organs with potential recipients, monitoring compliance
of member organizations with system rules, conducting statistical
analyses, and developing policies relating to organ procurement and
transplantation.
Description of Respondents: Non-profit institutions and small
organizations.

Estimated Annual Reporting and Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual number Annual Average burden Annual burden
Section Activity of respondents frequency per response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
121.6(e)......................... Transplant to prevent organ wastage.................. 268 4 0.1 107
121.11(b)(2)..................... Transplant candidate registration\1\................. 67 597 0.1 4,000
121.11(b)(2)..................... Donor registration\1\................................ 67 248 0.2 3,320
121.11(b)(2)..................... Potential recipient\1\............................... 67 266 0.1 1,780
121.11(b)(2)..................... Donor histocompatibility\1\.......................... 49 145 0.1 710
121.11(b)(2)..................... Transplant recipient histocompatibility\1\........... 49 347 0.1 1,700
121.11(b)(2)..................... Transplant recipient registration\1\................. 605 28 0.25 4,280
121.11(b)(2)..................... Transplant recipient follow-up\1\.................... 605 228 0.14 19,280
----------------------------------------------------------------------------------------------------------------------
Total.......................... ..................................................... .............. .............. .............. 35,177
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\The data collection forms for these activities have been approved by the Office of Management and Budget under the Paperwork Reduction Act (OMB No.
0915-0157).

The proposed rules also require OPOs and transplant hospitals to
maintain records, as follows:

------------------------------------------------------------------------
Section Requirement
------------------------------------------------------------------------
121.6(b)(3)......... Documentation of reason for refusal.
121.6(c)(2)......... Documentation of suitability tests.
121.11(a)(2)........ Maintain records on organ donors and recipients.
------------------------------------------------------------------------

According to staff of OPOs and transplant hospitals, such
recordkeeping is integral to the operation of these facilities.
Therefore, these recordkeeping requirements impose no additional
burden.
The Department has submitted a copy of this proposed rule to OMB
for its review of the reporting and recordkeeping requirements.
Organizations and individuals desiring to submit comments on these
information collection requirements should direct them to the agency
official whose name appears in this preamble and to the Office of
Information and Regulatory Affairs, OMB, New Executive Office Building,
(room 3208), Washington, DC 20503, ATTN: Desk Officer for HHS.

List of Subjects in 42 CFR Part 121

Organs--human, Organ procurement and transplantation network, Organ
transplantation, Hospitals.

Dated: October 15, 1993.
Philip R. Lee,
Assistant Secretary for Health.

Approved: May 16, 1994.
Donna E. Shalala,
Secretary.

Accordingly, the Department of Health and Human Services proposes
to add 42 CFR Part 121 to subchapter K to read as follows:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

Sec.
121.1 Applicability.
121.2 Definitions.
121.3 Composition.
121.4 Listing requirements.
121.5 Organ procurement.
121.6 Identification of organ recipient.
121.7 Allocation of organs.
121.8 Designated transplant program requirements.
121.9 Review and evaluation.
121.10 Appeals of OPTN policies and procedures.
121.11 Record maintenance and reporting requirements.

Authority: Sections 215 and 372 of the Public Health Service Act
(42 U.S.C. 216 and 274); section 1138 of the Social Security Act (42
U.S.C. 1320b-8).

Sec. 121.1 Applicability.

(a) The provisions of this part apply to the operation of the Organ
Procurement and Transplantation Network (OPTN).
(b) In accordance with section 1138 of the Social Security Act,
hospitals in which organ transplants are performed and which
participate in the programs under titles XVIII or XIX of that Act, and
organ procurement organizations designated under section 1138(b)(1)(F)
of the Social Security Act are subject to the requirements of this
part.

Sec. 121.2 Definitions.

As used in this part--
Act means the Public Health Service Act, as amended.
Designated transplant program means a transplant program that meets
the requirements of Sec. 121.8.
National list means the OPTN computer-based list of transplant
candidates nationwide.
OPTN computer match program means a computer-based program to
ensure the matching of donated organs with the best medically-suited
transplant candidates.
Organ means a human kidney, liver, heart, lung, or pancreas.
Organ procurement organization or OPO means an entity so designated
by the Secretary under section 1138(b) of the Social Security Act.
Organ procurement and transplantation network or OPTN means the
network established pursuant to section 372 of the Act.
Potential transplant recipient or potential recipient means a
transplant candidate who has been identified as medically qualified to
receive a transplant of a specific donated organ.
Scientific registry means the registry of information on transplant
recipients established pursuant to section 373 of the Act.
Secretary means Secretary of Health and Human Services and any
official of the Department of Health and Human Services to whom the
authority involved has been delegated.
Transplant candidate means an individual who has been identified as
medically qualified to benefit from an organ transplant.
Transplant hospital means a hospital in which organ transplants are
performed.
Transplant program means a program within a transplant hospital for
transplantation of a particular type of organ.
Transplant recipient means a person who has received an organ
transplant.

Sec. 121.3 Composition.

The OPTN shall be comprised of organizations, institutions, and
individuals.
(a) Board of Directors. The OPTN shall establish a Board of
Directors to be comprised of not less than 14 or more than 35 members
as follows:
(1) Composition. The Board of Directors shall include:
(i) two members each from, and elected by, the association
representing transplant coordinators, the association representing
organ procurement organizations, and the association representing
histocompatibility experts;
(ii) individual elected by a majority vote of the voting OPTN
membership, including at least two representatives each from the
following categories:
(A) transplant surgeons;
(B) transplant physicians;
(C) transplant hospitals;
(D) voluntary health associations;
(E) patient advocacy groups; and
(F) the general public including, but not limited to, patients,
donor families, and individuals from the fields of law, theology,
hospital administration, ethics, health care financing, computer
science, economics, sociology, and behavioral sciences; and
(iii) one representative elected by the membership in each of the
regions, if any, established by the OPTN.
(2) Diversity. The Board of Directors shall include:
(i) individuals representing the diversity of the population of
organ donors and recipients served by the OPTN, including minority and
gender representation reflecting that diversity; and
(ii) not more than 50 percent surgeons and physicians directly
involved in organ procurement and transplantation.
(3) Term. Individuals on the Board shall serve a two-year term.
(4) Executive committee. The Board of Directors shall every two
years elect an Executive Committee from the membership of the Board to
ensure continuity of leadership. The Executive Committee shall include
not more than 50 percent surgeons and physicians directly involved in
organ procurement and transplantation.
(5) Executive director. The Board of Directors shall appoint an
Executive Director of the OPTN whose term shall not exceed four years.
The Executive Director may be reappointed to successive terms upon the
Board's determination that she/he has successfully carried out her/his
responsibilities.
(6) Duties.
(i) The OPTN Board of Directors shall be responsible for
developing, with the advice of the OPTN membership and other interested
parties:
(A) general policies, procedures, and other issuances within the
mission of the OPTN as set forth in section 372 of the Act and the
Secretary's contract for the operation of the OPTN:
(B) medical criteria and related policies for the fair and
equitable allocation of human donor organs;
(C) policies, consistent with recommendations of the Centers for
Disease Control and Prevention, for the testing of organ donors and
follow-up of transplant recipients to prevent the spread of infectious
diseases; and
(D) standards for the training and experience of transplant
surgeons and transplant physicians required by Sec. 121.8(a)(2)(ii) and
(iii). The OPTN shall develop these standards in accordance with the
public participation process set forth in Sec. 121.7(b).
(ii) The OPTN Board of Directors shall provide to the Secretary
copies of the policies, procedures, and issuances as they are adopted,
and make them available to the public upon request. The Secretary will
periodically publish lists of these documents in the Federal Register.
(b) Committees. Committees established by the Board of Directors
shall include, to the extent practicable, minority and gender
representation reflecting the diversity of the population of organ
donors and recipients served by the OPTN.
(c) OPTN membership. The OPTN shall admit and retain as members the
following:
(1) All organ procurement organizations designated by HHS under
section 1138(b) of the Social Security Act;
(2) All hospitals participating in the Medicare or Medicaid
programs which perform transplants; and
(3) Organizations (other than OPOs described in paragraph (c)(1) of
this section and transplant hospitals described in paragraph (c)(2) of
this section), institutions, or individuals that have an ongoing
interest in the field of organ transplantation.
(d) Review of applications and documentation.
(1) To apply for membership in the OPTN:
(i) OPOs shall provide to the OPTN the name and address of the OPO,
and the latest year of designation under section 1138(b) of the Social
Security Act;
(ii) hospitals shall provide to the OPTN in writing the name and
address of the hospital, a list of its transplant programs, if any, by
type of organ; and
(iii) organizations, institutions, and individuals eligible under
paragraph (c)(3) of this section shall provide to the OPTN
documentation which demonstrates their interest in the field of organ
transplantation.
(2) The OPTN shall accept as members entities described in
paragraphs (c) (1) and (2) of this section and shall accept or reject
applications from entities described in paragraph (c)(3) of this
section.
(3) Applicants rejected for membership in the OPTN may appeal to
the Secretary. Appeals shall be submitted in writing within 30 days of
rejection of the application. The Secretary may:
(i) deny the appeal; or
(ii) direct the OPTN to take action consistent with the Secretary's
response to the appeal.

Sec. 121.4 Listing requirements.

(a) Transplant candidate listing.
(1) An OPTN member may list transplant candidates only for a
designated transplant program.
(2) Transplant hospitals shall assure that all transplant
candidates are placed on the national list as soon as they are
determined to be candidates for transplantation. The OPTN shall from
time to time advise members of the information needed for such listing.
(3) An OPTN member shall pay a registration fee to the OPTN for
each transplant candidate it places on the national list. The amount of
such fee shall be determined by the OPTN with the approval of the
Secretary.
(b) Donor listing. OPTN members that procure organs shall submit to
the OPTN such data as the OPTN shall prescribe on each organ procured,
within the time prescribed by the OPTN.

Sec. 121.5 Organ procurement.

The suitability of organs donated for transplantation shall be
determined as follows:
(a) Tests. An OPTN member procuring an organ shall assure that
laboratory tests and clinical examinations of potential organ donors
are performed to determine any contraindications for donor acceptance,
in accordance with policies established by the OPTN.
(b) HIV. Organs from potential donors known to be infected with
Human Immunodeficiency Virus shall not be procured for transplantation.
(c) Acceptance criteria. Transplant programs may establish criteria
for organ acceptance, and shall provide such criteria to their OPOs and
to the OPTN.

Sec. 121.6 Identification of organ recipient.

(a) List of potential transplant recipients.
(1) An OPTN member procuring an organ shall operate the OPTN
computer match program within such time as the OPTN may prescribe to
identify and rank potential recipients for each cadaveric organ
procured.
(2) The rank order shall be determined for each cadaveric organ
using the organ specific allocation criteria established in accordance
with Sec. 121.7.
(3) Where a donor organ does not meet a transplant program's donor
acceptance criteria, as established under Sec. 121.5(c), transplant
candidates of that hospital shall not be ranked among potential
recipients of that organ and shall not appear on a roster of potential
recipients of that organ.
(b) Offer of organ to potential recipients.
(1) Organs shall be offered to potential recipients in rank order,
in accordance with policies adopted under Sec. 121.7.
(2) Organs may be offered only to potential recipients listed with
transplant hospitals having designated transplant programs of the same
type as the organ procured.
(3) An organ offer is made by the OPTN member which procured the
organ when all information necessary to determine whether to transplant
the organ into the potential recipient has been given to the transplant
hospital.
(4) A transplant hospital shall either accept or refuse the offered
organ within such time as the OPTN may prescribe. A transplant hospital
shall document the reasons for refusal.
(c) Transportation of organ to potential recipient.
(1) Transportation. The OPTN member that procures a donated organ
shall arrange for transportation of the organ to the transplantation
site.
(2) Documentation. The OPTN member that is transporting an organ
shall assure that it is accompanied by written documentation of
activities conducted to determine the suitability of the organ donor.
(3) Packaging. The OPTN member that is transporting an organ shall
assure that it is packaged to assure viability upon receipt.
(d) Receipt of an organ. Upon receipt of an organ, the transplant
hospital responsible for the potential recipient's care shall determine
whether to proceed with the transplant. In the event that an organ is
not transplanted into the potential recipient, the transplant hospital
must offer the organ to another potential recipient in accordance with
paragraph (b) of this section.
(e) Wastage. Nothing in this section shall prohibit any OPTN member
from transplanting an organ into any medically suitable candidate if to
do otherwise would result in the organ not being used for
transplantation. The member shall notify the OPTN of the circumstances
justifying each such action within such time as the OPTN may prescribe.

Sec. 121.7 Allocation of organs.

(a) Policy development. The Board of Directors established under
Sec. 121.3(a) shall develop policies for the fair and equitable
allocation of human cadaveric organs among potential recipients. Such
policies shall be patent-based and take into account significant
factors affecting quality of care and patient and organ graft survival
including:
(1) established medical criteria for transplantation of organs;
(2) the length of time potential recipients have been on the
national list;
(3) potential recipients whose immune system makes it difficult for
them to receive organs; and
(4) minimizing wastage of the scarce supply of human organs for
transplantation.
(b) Public participation.
(1) The OPTN shall provide opportunity for the OPTN membership and
other interested parties to comment on proposed policies and, at the
same time, provide the proposed policies to the Secretary for
publication in the Federal Register to obtain comments from the public.
(2) The Board of Directors shall take into account the comments
received in developing and adopting final policies for implementation
by the OPTN.
(3) The OPTN shall provide the proposed final policies to the
Secretary, who shall have 30 days in which to provide comments and/or
objections. The OPTN shall take into account any comments the Secretary
may provide. If the Secretary objects to a policy, the OPTN may be
directed to revise the policy consistent with the Secretary's
direction.
(4) OPTN members, individuals, or entities objecting to final
policies may submit appeals to the Secretary in writing within 30 days
of adoption of the final policies by the OPTN. The final policy remains
in effect during this period. The Secretary may:
(i) deny the appeal; or
(ii) direct the OPTN to revise the policies consistent with the
Secretary's response to the appeal.
(c) Policy implementation.
(1) The OPTN shall implement allocation policies adopted and
approved by the Secretary, and provide information to OPTN members
about these policies and the rationale for them.
(2) The Board of Directors shall update policies developed in
accordance with this section to keep them current with scientific and
technological advances.
(d) Directed donation. Nothing in this section shall prohibit the
allocation of an organ to a recipient named by those authorized to make
the donation.

Sec. 121.8 Designated transplant program requirements.

(a) To receive organs for transplantation, transplant programs
shall abide by these rules and OPTN policies, procedures, and
issuances, and shall:
(1) be an organ transplant program approved by HHS under applicable
regulations for reimbursement under Medicare and Medicaid; or
(2) be an organ transplant program which:
(i) has letters of agreement or contracts with an OPO;
(ii) has on site a transplant surgeon qualified in accordance with
standards developed under Sec. 121.3(a)(6)(i)(D);
(iii) has on site a transplant physician qualified in accordance
with standards developed under Sec. 121.3(a)(6)(i)(D);
(iv) has available operating and recovery room resources, intensive
care resources and surgical beds and transplant program personnel;
(v) shows evidence of collaborative involvement with experts in the
fields of radiology, infectious disease, pathology, immunology,
anesthesiology, physical therapy and rehabilitation medicine and, as
appropriate, hepatology, pediatrics, nephrology with dialysis
capability, and pulmonary medicine with respiratory therapy support;
(vi) has immediate access to microbiology, clinical chemistry,
tissue typing, radiology and blood banking services, as well as the
facilities required for monitoring immunosuppressive drugs; and
(vii) makes available psychiatric and social support services for
transplant recipients and their families; or
(3) be a transplant program in a Veterans Administration hospital
which is a Dean's Committee hospital which shares a common university-
based transplant team of a transplant program which meets the
requirements of Sec. 121.8(a) (1) or (2).
(b) To apply to be a designated transplant program, transplant
programs shall provide to the OPTN such documents as the OPTN may
require which show that they meet the requirements of Sec. 121.8(a)
(1), (2), or (3).
(c) The OPTN shall accept or reject applications to be a designated
transplant program.
(d) Applicants rejected for designation may appeal to the
Secretary. Appeals shall be submitted in writing within 30 days of
rejection of the application. The Secretary may:
(1) deny the appeal; or
(2) direct the OPTN to take action consistent with the Secretary's
response to the appeal.

Sec. 121.9 Review and evaluation.

(a) Review and evaluation by the Secretary. The Secretary or her/
his designee may perform any reviews and evaluations of member OPOs and
transplant hospitals which the Secretary deems necessary to carry out
her/his responsibilities under the Public Health Service Act and the
Social Security Act.
(b) Review and evaluation by the OPTN--
(1) The OPTN shall design appropriate plans and procedures,
including survey instruments and data systems, for purposes of:
(i) reviewing applications submitted under Sec. 121.3(d)(1) for
membership in the OPTN;
(ii) reviewing applications submitted under Sec. 121.8(b) to be a
designated transplant program; and
(iii) conducting ongoing and periodic reviews and evaluations of
each member OPO and transplant hospital for compliance with these
regulations.
(2) Upon the approval of the Secretary, the OPTN shall furnish
review plans and procedures, including survey instruments and a
description of data systems, to each member OPO and transplant
hospital. The OPTN shall furnish any revisions of these documents to
member OPOs and hospitals, after approval by the Secretary, prior to
their implementation.
(c) Enforcement of OPTN rules.
(1) OPTN recommendations. The Board of Directors shall advise the
Secretary of the results of any reviews and evaluations conducted under
paragraph (b)(1)(iii) of this section which, in the opinion of the
Board, indicate noncompliance with this part, and provide any
recommendations for appropriate action by the Secretary.
(2) Secretary's action on recommendations. Upon the Secretary's
review of the Board of Directors' recommendations, the Secretary may:
(i) request further information from the Board of Directors or the
alleged violator, or both;
(ii) decline to accept the recommendation;
(iii) accept the recommendation, and notify the alleged violator of
the Secretary's decision; or
(iv) take such other action as the Secretary deems necessary.

Sec. 121.10 Appeals of OPTN policies and procedures.

(a) Any individual or entity may appeal to the Secretary any
policy, procedure, or issuance of the OPTN. Any such appeal shall
include a statement of the basis for the appeal. The Secretary will
seek the comments of the OPTN on the issues raised in the appeal. The
Secretary may deny the appeal or direct the OPTN to revise the policy,
procedure, or issuance consistent with the Secretary's response to the
appeal.
(b) The Secretary may object to any policy, procedure, or issuance
of the OPTN, and the OPTN may be directed to revise the policy,
procedure, or issuance in accordance with the Secretary's direction.

Sec. 121.11 Record maintenance and reporting requirements.

(a) Record maintenance. Records shall be maintained and made
available subject to applicable limitations based on personal privacy
as follows:
(1) OPTN--(i) The OPTN shall maintain and operate in accordance
with Sec. 121.4 an automated system for managing information about
organ transplant candidates, recipients, and donors, including a
computerized national list of individuals waiting for transplants.
(ii) The OPTN shall maintain records of all transplant candidates,
all organ donors and all transplant recipients.
(2) Organ procurement organizations and transplant hospitals--(i)
Maintenance of records. All OPOs and transplant hospitals shall
maintain such records pertaining to each potential donor identified,
each organ retrieved and each recipient transplanted as the Secretary
deems necessary to carry out her/his responsibilities under the Act.
(ii) Access to facilities and records. OPOs and transplant
hospitals shall permit the Secretary and the Comptroller General, or
their designees, to inspect facilities and records pertaining to any
aspect of services performed related to organ donation and/or
transplantation.
(b) Reporting requirements.
(1) The OPTN shall:
(i) in addition to special reports which the Secretary may require,
submit to the Secretary a report once every fiscal year on a schedule
prescribed by the Secretary. The report shall include the following
information in a form prescribed by the Secretary:
(A) Information that the Secretary prescribes as necessary to
assess the effectiveness of the Nation's organ donation, procurement
and transplantation system.
(B) Any other information that the Secretary prescribes.
(ii) provide to the Scientific Registry data on transplant
candidates and recipients, and other information that the Secretary
deems appropriate. The information shall be provided in a form and on a
schedule prescribed by the Secretary.
(2) An organ procurement organization or transplant hospital shall,
as specified from time to time by the Secretary, submit to the OPTN
information regarding transplantation candidates, recipients and donors
of organs. Such information shall be in the form required and shall be
submitted in accordance with the schedule prescribed.

[FR Doc. 94-21993 Filed 9-7-94; 8:45 am]
BILLING CODE 4160-15-M