optn final rule

federal register

Wednesday
October 20, 1999

Part VI

Department of
Health and Human
Services
Health Resources and Services
Administration
42 CFR Part 121
Organ Procurement and Transplantation
Network; Final Rule

56650

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
42 CFR Part 121
Organ Procurement and
Transplantation Network
Health Resources and Services
Administration, HHS.
ACTION: Final rule.
AGENCY:

SUMMARY: This document sets forth
improvements to the final rule
governing the operation of the Organ
Procurement and Transplantation
Network (OPTN), published in 1998. It
reflects the advice of a panel convened
by the National Academy of Science’s
Institute of Medicine, as called for in the
Department’s appropriation act for 1999.
It also reflects comments on the 1998
rule and consultation with
representatives of the organ
transplantation community, as
recommended in the same legislation;
and it summarizes new transplant data
developed in the period since
enactment of the appropriations act.
DATES: The final rule published on April
2, 1998, 63 FR 16296, adding 42 CFR
part 121 with an effective date of
October 1, 1998, as amended on July 1,
1998, 63 FR 35847, did not take effect
under section 213(a) within Public Law
105–277, 112 Stat. 2681, 2681–359
through 2681–360, approved October
21, 1998. The April 2, 1998 rule as
amended by this document, is effective
on November 19, 1999.
FOR FURTHER INFORMATION CONTACT:
D.W. Chen, M.D., M.P.H., Director,
Division of Transplantation, Office of
Special Programs, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 7C–22, Rockville, MD
20857, telephone 301–443–7577.
SUPPLEMENTARY INFORMATION: On April
2, 1998, the Department of Health and
Human Services (HHS) published in the
Federal Register a final rule pertaining
to the operation of the Organ
Procurement and Transplantation
Network (63 FR 16296). In accordance
with the National Organ Transplant Act
(NOTA) of 1984, as amended, the
purpose of the final rule is to help
achieve the most equitable and
medically effective use of human organs
that are donated in trust for
transplantation. Toward this end, the
final rule establishes performance goals
intended to bring about:
(1) Standardized criteria for placing
patients on transplant waiting lists, (2)
standardized criteria for defining a

patient’s medical status, and (3)
allocation policies that make most
effective use of organs, especially by
making them available whenever
feasible to the most medically urgent
patients who are appropriate candidates
for transplantation. The final rule also
sets standards for availability of organ
transplantation data, and it addresses
the governing structure of the OPTN. No
provision of the final rule is intended to
interfere with the discretion of
individual health professionals and
patients in medical decision-making,
and the rule looks to the OPTN to
design organ allocation policies. At the
same time, the rule defines the policy
oversight responsibilities of the
Secretary of HHS. In concert with efforts
to encourage organ donation, the final
rule is intended to help make best use
of the limited number of organs
available for transplantation.
The final rule invited further
comments, which have been received
and reviewed. In addition, the Omnibus
Consolidated and Emergency
Supplemental Appropriations Act for
1999 delayed implementation of the
final rule until October 21, 1999. (This
Omnibus Act, Public Law 105–277, at
section 101(f) of Division A, enacted the
Department of Labor, HHS, and
Education, and Related Agencies
Appropriations Act, 1999. Within the
latter act, section 213 included
provisions related to the final OPTN
rule, 112 Stat. 2681, 2681–359 through
2681–360. Hereafter, for ease of
reference, we will refer to section 213 of
the Appropriation Act, or simply
section 213.) Section 213 called for
independent review through the
National Academy of Science’s Institute
of Medicine. It also suggested
development of improved information
on the effectiveness of the
transplantation system, including
center-specific information if possible.
Finally, it suggested further discussions
between HHS and representatives of the
transplant community. Each of these
areas has been addressed.
I. Background
A. Legislative and Regulatory History
Legislative and regulatory history are
outlined in the preamble to the April 2,
1998, final rule. In addition to the
underlying statute (sections 371–376 of
the Public Health Service Act, as
enacted by the National Organ
Transplant Act of 1984, and as
subsequently amended), of particular
importance is section 1138 of the Social
Security Act, enacted in 1986. This
legislation requires hospitals that
perform organ transplants to be

members of, and abide by the rules and
requirements of, the OPTN as a
condition for participation in the
Medicare and Medicaid programs. This
provision subjects a transplant
hospital’s entire Medicare and Medicaid
participation, and thus in reality its
economic survival, to OPTN policy and
enforcement. A similar provision in
section 1138 affects funding under
Medicare and Medicaid for organ
procurement organizations (OPOs). But
authority for establishing conditions of
participation in Medicare and Medicaid
resides with the Secretary and cannot be
exercised by another party without
either oversight authority or delegation.
Thus, review and oversight authority of
OPTN policies by the Secretary of HHS
is made even more necessary by section
1138. A Federal Register notice
published on December 18, 1989 (54 FR
51802) addressed this need by stating
that no OPTN policies are legally
binding ‘‘rules or requirements’’ of the
OPTN for purposes of section 1138,
unless they have been approved by the
Secretary. The final rule published
April 2, 1998, defines the structure for
such review and approval, thus setting
the stage for OPTN ‘‘rules or
requirements’’ that would be
enforceable on transplant hospitals and
OPOs under section 1138.
In October 1998, section 213 of the
Appropriation Act delayed
implementation of the final rule to
October 21, 1999. Section 213 directed
that the Institute of Medicine conduct a
review of the current policies of the
OPTN and the final rule. Section 213
also suggested that the Secretary ‘‘may
conduct a series of discussions with the
OPTN in order to resolve issues raised
by the final rule.’’ In addition, section
213 indicated a need for improved
availability of data on transplantation
and transplant center performance.
B. Institute of Medicine Report
The Institute of Medicine (IOM)
issued its report, Organ Procurement
and Transplantation, on July 22, 1999.
The report included five major
recommendations. The Department has
relied heavily on the guidance in the
IOM report in reviewing the provisions
of its final rule. In general, the IOM
report validates the concerns that gave
rise to the final rule and the approaches
taken in the rule:
Recommendation 1: Establish Organ
Allocation Areas for Livers. The committee
recommends that the DHHS Final Rule be
implemented by the establishment of Organ
Allocation Areas (OAAs) for livers—each
serving a population base of at least 9 million
people (unless such an area would exceed
the limits of acceptable cold ischemic time).

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations
OAAs should generally be established
through sharing arrangements among organ
procurement organizations to avoid
disrupting effective current procurement
activities.
Recommendation 2: Discontinue Use of
Waiting Time as an Allocation Criterion for
[Liver Transplant] Patients in Statuses 2B
and 3. The heterogeneity and wide range of
severity of illness in statuses 2B and 3 make
waiting time relatively misleading within
these categories. For this reason, waiting time
should be discontinued as an allocation
criterion for status 2B and 3 patients. An
appropriate medical triage system should be
developed to ensure equitable allocation of
organs to patients in these categories. Such
a system may, for example, be based on a
point system arising out of medical
characteristics and disease prognoses rather
than waiting times.
Recommendation 3: Exercise Federal
Oversight. The Department of Health and
Human Services should exercise the
legitimate oversight responsibilities assigned
to it by the National Organ Transplant Act,
and articulated in the final rule, to manage
the system of organ procurement and
transplantation in the public interest. This
oversight should include greater use of
patient-centered, outcome-oriented
performance measures for OPOs, transplant
centers, and the OPTN.
Recommendation 4: Establish Independent
Scientific Review. The Department of Health
and Human Services should establish an
external, independent, multidisciplinary
scientific review board responsible for
assisting the Secretary in ensuring that the
system of organ procurement and
transplantation is grounded on the best
available medical science and is as effective
and as equitable as possible.
Recommendation 5: Improve Data
Collection and Dissemination. Within the
bounds of donor and recipient confidentiality
and sound medical judgment, the OPTN
contractor should improve its collection of
standardized and useful data regarding the
system of organ procurement and
transplantation and make it widely available
to independent investigators and scientific
reviewers in a timely manner. The
Department of Health and Human Services
should provide an independent, objective
assessment of the quality and effectiveness of
the data that are collected and how they are
analyzed and disseminated by the OPTN.

In addition, the General Accounting
Office (GAO) made findings in two
other areas required by section 213: the
possibility of legal liability of OPTN
members arising from their peer review
activities and the confidentiality of
information. Regarding liability, the
General Counsel of the GAO found no
apparent conflict between the final rule
and State laws governing peer review.
Regarding confidentiality, the General
Counsel found that the Secretary of HHS
has authority under the final rule to
decide that the public interest in
disclosure of information about organ

transplants outweighs the interest in
confidentiality.
C. Discussions With the Transplant
Community
Representatives of HHS met with
members of the transplant community
on numerous occasions in the period
immediately following publication of
the final rule. Since enactment of
section 213, representatives of HHS
have met on 11 separate occasions with
representatives of 11 transplant
organizations: United Network for
Organ Sharing (UNOS, the current
OPTN contractor), Transplant
Recipients International Organization,
American Liver Foundation, National
Transplant Action Committee, National
Minority Organ and Tissue Transplant
Education Program, National Kidney
Foundation, Patient Access to
Transplantation Coalition, American
Society of Transplantation, American
Society of Transplant Surgeons, North
American Transplant Coordinators
Organization, and the American
Nephrology Nurses Association. On
September 15, 1999, an additional
meeting with representation invited
from all of these organizations took
place to discuss together issues that had
been surfaced.
Clarifications
HHS is further clarifying these issues
with this publication:
• ‘‘National’’ lists: The final rule does
not require single national lists for
allocation of organs, beyond the
national registry lists already utilized by
the OPTN. As underscored by the IOM
recommendations, it is the Department’s
goal to achieve sharing of organs broad
enough to achieve medically effective
results for patients, especially by
providing organs for patients with
greatest medical urgency who are
appropriate candidates for
transplantation. When using the terms
‘‘greatest medical urgency,’’ or ‘‘most
medically urgent,’’ the Department is
referring to transplanting those patients
whose medical condition, in the
judgment of their physicians, makes
them suitable candidates for
transplantation. The final rule directs
the OPTN to overcome as much as
possible arbitrary geographic barriers to
allocation that restrict the allocation of
organs to patients with greatest medical
urgency who are appropriate candidates
for transplantation and that are not
based on medical criteria. Broader
sharing was an essential element of the
IOM’s findings.
• Most Medically Urgent Patients:
The final rule follows, and intends to
expand, existing policy in serving most

56651

medically urgent patients first, again,
referring to patients who are suitable
candidates for transplantation. It is not
the Department’s intention to require
transplantation of patients too ill to
benefit; the final rule specifically
prohibits policies that might result in
such futile transplantations and organ
wastage. Providing available organs to
patients with greatest medical urgency
who are appropriate candidates for
transplantation is already the policy of
the OPTN within allocation areas.
Transplant priority for patients with
greatest medical urgency, whenever
they are medically suitable, follows the
tenets of medical practice generally and
is already accepted throughout the
transplant community and general
public.
• Medical Factors Affecting Organ
Movement: The final rule fully
recognizes limitations on movement of
organs resulting from medical factors,
especially limits of ischemic time. As
recommended by the IOM report, and as
intended by the 1998 final rule, sharing
of organs should be broad enough to
enable medically effective use of organs,
especially to enable organs to reach the
most medically urgent patients, but
ischemic time limits and any other
medical factors affecting the viability of
the organ must be considered in
designing allocation policies.
• Small and Medium Sized
Transplant Centers: The Department
does not expect the final rule to cause
the closure of small or medium sized
transplant centers or otherwise diminish
access to transplantation for certain
populations, including those living in
rural areas. The IOM report did not find
evidence that the rule would have such
effects; and a report by the HHS Office
of Inspector General (‘‘Fostering Equity
in Patient Access to Transplantation:
Local Access to Liver Transplantation,’’
dated August 1999) concluded that
geographic distribution of liver
transplant centers is unlikely to change
as a result of national policies on organ
allocation. The Department is concerned
that patient access to transplant services
not be adversely affected by closure of
centers that are providing quality care,
including small and medium sized
centers. Thus, the amendments below
include provision for monitoring any
effects of policy changes on small and
medium sized centers. However, HHS
and the OPTN should work together to
ensure that all transplant programs,
regardless of volume, are providing
quality care to candidates and
recipients.
• Designated Transplant Program
Requirements: The final rule carries
forward the policies in the proposed

56652

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations

rule that provided separate staffing and
organizational ‘‘designated transplant
program’’ requirements for nonMedicare participating transplant
programs and those that are certified as
Medicare approved transplant programs.
The Department has received comments
similar to those submitted in response
to the proposed rule, suggesting that
uniform standards be applied for
designation status. The Department
continues to have no objection to this
suggestion in principle, but believes that
the OPTN should submit such standards
for the Secretary’s consideration as
possible changes to the Medicare
conditions for coverage of organ
transplants, which currently contain
similar requirements.
Secretarial Oversight and Enforceability
of OPTN Policies
Virtually all commenters agreed that
HHS should exercise an oversight role
over OPTN policies, although there
were different views among the
participants as to how such oversight
should be carried out. Exercise of HHS
oversight was also one of the five
primary recommendations of the IOM
report. Further, as explained in
‘‘Legislative and Regulatory History’’
above, section 1138 of the Social
Security Act elevates OPTN
membership and policies to the status of
requirements for participation in
Medicare and Medicaid for transplant
hospitals and OPOs, thus necessitating
Secretarial review and oversight
authority over those policies. The final
rule provides the framework for such
oversight as well as the framework for
creating a body of enforceable OPTN
policies.
An additional recommendation by the
IOM was establishment of an
independent scientific review board
‘‘for assisting the Secretary in ensuring
that the system of organ procurement
and transplantation is grounded on the
best available medical science and is as
effective and as equitable as possible.’’
In response to this recommendation in
the IOM report as well as comments
received, the Department intends to
create such an advisory board, the
Advisory Committee on Organ
Transplantation. The Department
intends to implement the IOM’s
recommendations that this Committee
have several key responsibilities. As
recommended by the IOM, the
Committee will provide ‘‘timely,
nonpartisan review’’ to ‘‘assist the
Secretary in managing the system in a
manner that best serves the public
interest.’’ It will also, as recommended
by the IOM, ‘‘help provide objective
information and advice for future

directions for the [organ transplantation]
system.’’ It would also, as recommended
by the IOM, ‘‘help insure that policies
and procedures are evidence-based and
guided by the best available scientific
and medical precepts.’’ In order that the
Committee fulfill this latter
responsibility, § 121.4 (b)(2) and (d)
have been revised to reflect this role.
When the OPTN proposes enforceable
policies, the Secretary will ask the
Committee for its views on the
proposals when the proposals are
published in the Federal Register for
public comment. The Committee’s
views, public comments, and the
Department’s views will then serve as
the basis for discussions with the OPTN.
If, after these discussions, the Secretary
wishes to direct that the OPTN revise its
proposals, the OPTN will have the
opportunity to suggest revisions. If the
Secretary does not agree with the
OPTN’s revised approach (or if it does
not respond in a timely manner), the
Secretary may require the OPTN to take
other appropriate actions. However, the
Secretary will ask the Committee for its
views on the specific proposed actions
before transmitting them to the OPTN.
A similar approach may also be used
should the Secretary review other OPTN
policies, or elect to evaluate critical
comments received by the Secretary
relating to the manner in which the
OPTN is carrying out its duties.
It is not the desire, nor is it the
intention, of the Department to interfere
in the practice of medicine. Decisions
about who should receive a particular
organ in a particular situation involve
levels of detail, subtlety, and urgency
that must be judged by transplant
professionals. The Advisory Committee
will greatly assist the Secretary with
respect to the medical and scientific
components of OPTN policies. The
medical community has substantial
contributions to make within the
deliberative process for developing
OPTN policies, as well as in individual
decisions involved in clinical
transplantation practice.
The rule also has been revised to
emphasize that the Secretary’s review is
intended to ensure consistency between
OPTN policies and the National Organ
Transplant Act and this regulation. This
revision is intended to emphasize, as
the IOM did in its report, that the
Secretary’s oversight will further the
public interest, a role assigned to the
Department by the National Organ
Transplant Act and articulated in this
regulation.
OPTN Board Composition
Participants expressed a variety of
views on requirements concerning the

composition of the OPTN Board of
Directors. Some participants believed
that the rule should require, not merely
authorize, the Board to include at least
50 percent representation of transplant
physicians and transplant surgeons, to
ensure a preponderance of medical
expertise. Others suggested more even
division of representation among
transplant physicians and transplant
surgeons, other non-physician
transplant professionals, and
candidates, recipients, donors, their
families, and the general public.
Concern was also raised that a
combination of percentage
representation requirements with
specific categorical representation
requirements would make the Board so
large as to be unwieldy, if the Board
chose to allow 50 percent representation
of transplant physicians and surgeons.
The Department has reorganized and
revised the Board and Executive
Committee composition provisions to
strengthen the role of transplant
physicians and surgeons on the Board,
consistent with the rule’s thrust that
allocation policy (one of the OPTN’s
most important responsibilities) be
based on objective and measurable
medical criteria and sound medical
judgment, to strengthen the role of
transplant candidates, recipients,
donors, and their families on the Board
and its Executive Committee, and to
provide the OPTN greater flexibility in
determining the appropriate size for the
Board. This document includes
amendments that identify categories of
membership, but do not require a
specific number of members from each
category. This amendment requires
approximately 50 percent transplant
physician or transplant surgeon
membership, instead of no more than 50
percent, and specifies at least 25 percent
transplant candidates, transplant
recipients, organ donors, and family
members.
We have retained the provision
designed to avoid even an appearance of
a conflict of interest by requiring that
transplant candidates, recipients,
donors and family members on the
Board not have an ‘‘employment or
similar relationship’’ with certain
entities and individuals involved in
transplantation. However, we received
comments suggesting that such
individuals may have exceptional
commitment or knowledge and should
not be automatically disqualified from
Board membership, and that, in any
event, the Board should have additional
flexibility in this area. We have revised
this provision to authorize the Board to
waive this requirement for up to half of

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations
these members. We expect the Board to
use this flexibility consistent with the
rule’s goal of broad involvement of
patients, recipients, donors, families
and the public in the formulation of
transplant policy.
Broader Geographic Sharing of Organs
The final rule’s emphasis on broader
sharing of organs is being clarified
through this document. Establishment
of liver allocation areas broad enough to
provide for medically effective
allocation of organs was the leading
recommendation of the IOM report.
Some commenters expressed concern
about the need for the transplant system
to use standard criteria for listing
patients and assigning their urgency
status, and likewise the need for
enforcement mechanisms to ensure that
medically urgent patients who are
appropriate candidates for
transplantation are not disadvantaged
through misuse of listing criteria or
priority rankings. The final rule calls on
the OPTN to develop such standard
criteria, and to monitor compliance with
them, prospectively if appropriate.
Further, by establishing a framework for
Secretarial review and approval of
OPTN policies, as well as review and
evaluation procedures for the OPTN, the
rule provides a foundation for
enforcement of these standard criteria.
Frequency and Timeliness of Data
Most participants expressed support
for enhanced frequency and timeliness
of data. Likewise, the IOM report
strongly urged improvements in data
collection and dissemination, both for
physician and patient information and
to provide outcome data that may
improve understanding of best medical
practices. As OPTN contractor, UNOS
expressed concern about its ability to
meet the frequency requirements in the
April 2 final rule. The Department has
decided to retain the 6 month data
presentation requirement. The
Department recognizes that UNOS’
concerns stem in part from its belief that
certain types of data may not need to be
updated as frequently as others.
Therefore, the Department has added a
provision that would permit longer
intervals for certain data.
The Department recognizes the
progress that UNOS has made in
increasing the availability of programspecific information for use by patients,
families, physicians, and payors. To
respond to the contractor’s concerns
regarding its ability to meet the
frequency of the reporting requirement
in the final rule, HHS will not require
the submission of the first programspecific report under § 121.11(b)(1)(iv)

until June 30, 2000. This will allow
OPTN member organizations adequate
time to become fully Y2K compliant and
ensure that all data submitted to the
OPTN is done so electronically, and will
enable the contractor to meet the
Department’s and the IOM’s
expectations that information be more
timely and accessible.
Use of Waiting Time
In general, the IOM found the
emphasis on cumulative waiting times
to be inappropriate as a measure of
equity in the transplant system and as
a criterion for allocation for less
medically urgent patients, pointing
instead toward ‘‘more meaningful
indicators of equitable access’’ such as
‘‘status-specific rates of
pretransplantation mortality and
transplantation.’’ The IOM report
indicated, however, that the use of
‘‘waiting times in status’’ for the most
medically urgent liver transplant
patients (those in status 1 and 2A) was
‘‘an appropriate criterion, along with
necessary medical criteria.’’ For less
medically urgent patients (statuses 2B
and 3), the IOM recommended that the
OPTN discontinue use of waiting time
as an allocation criterion and instead
develop ‘‘an appropriate medical triage
system . . . to ensure equitable
allocation of organs to patients in these
categories.’’ HHS generally agrees with
these findings, although the Department
believes that waiting time in status
(unlike cumulative waiting time) can be
one among several useful criteria in
assessing variability in results for
patients at different transplant centers.
To date, waiting times have been used
in examining the performance of the
transplant system in part because
waiting times are used by the OPTN as
an allocation criterion, and in part due
to lack of better measures. It is for these
reasons that reducing any variations in
‘‘waiting time in status,’’ especially for
the most medically urgent patients, was
included as a performance measure in
the final rule published April 2. In
addition, the IOM recommendation
points again to the need for better data
to provide alternatives to waiting time
as a performance measure. Based on the
IOM’s recommendations and comments
from the transplant community, the
Department has made additional
refinements to the rule’s discussion of
waiting times.
The Department’s approach in this
section follows the recommendations of
the IOM and responds to issues raised
by commenters. First, the Department
agrees with the IOM recommendations
that ‘‘overall’’ waiting times are an
inappropriate measure. The concept of

56653

using ‘‘waiting time in status’’ is,
however, permitted as a factor in
allocation policy.
Second, § 121.8(b)(4) requires the
OPTN to use performance indicators to
assess transplant program performance
and to seek to reduce the variations
among transplant programs with respect
to selected performance indicators. This
‘‘performance indicator’’ approach is
consistent with the IOM’s
recommendation that data be used to
assess transplant program performance.
Among the alternatives available to the
OPTN is the performance indicator
‘‘waiting time in status.’’ Consistent
with the IOM’s approach, if the OPTN
retains waiting time in status for
allocation purposes for medically urgent
categories similar to current Status 1
and 2A in its revised liver allocation
policies, the Department would expect
the OPTN to use waiting time in status
as a performance indicator for liver
patients, along with necessary medical
criteria.
Regarding the general approach of
reducing variations among transplant
programs with respect to selected
performance indicators, we also expect
the OPTN to work towards improving,
where possible, the outcomes under
these indicators. For example, if the
OPTN used the performance indicator
pretransplantation mortality rates for
liver patients by medical status, as
recommended by the IOM, then the
Department would expect the OPTN to
seek to reduce the variations in this
performance indicator by improving
pre-transplant survival at programs
where it fell significantly below the
national rates.
We also note that, although
§ 121.8(b)(2) requires that the medical
characteristics of patients within each
category be as similar as possible, the
IOM observed that the current liver
status categories 2B and 3 were
heterogeneous. As a result, some
patients in these categories need lifesaving transplants sooner than others.
The other patients, often with longer
waiting times, can, nevertheless, wait
longer periods of time without increased
risk of death. Therefore, the IOM
concluded that the OPTN should not
use waiting times as a criterion for
patients in these categories. Some
commenters, however, suggested that
the OPTN would have difficulty further
refining its existing status categories.
Commenters also requested that the
OPTN be allowed to continue to use
waiting times in some fashion for these
patients. This rule provides the OPTN
flexibility to continue to use waiting
times for patients in these categories but
would require that such use not

56654

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations

override medical urgency
considerations.
However, the Department expects, as
the IOM concluded, that broader sharing
of organs should occur for all patients
and that organs will go to more
medically urgent patients who are
appropriate candidates for transplants
before being offered to patients whose
condition permits them to wait longer
for a transplant.
OPTN Review of Member Compliance
With Final Rule Requirements and
Mandatory OPTN Policies
Many members of the transplant
community expressed concern about
how best to promote compliance with
OPTN policies. Section 121.8(a)(7) has
been added to emphasize that the OPTN
should especially promote compliance
with approved allocation policies
through prospective and retrospective
reviews of programs’ compliance with
allocation policies. In addition, the
OPTN is required by § 121.10 to conduct
reviews and evaluations of each OPTN
member’s compliance with these rules
and approved OPTN policies. Thus, the
OPTN is required to implement a review
process to ensure that individuals
receiving transplants are accurately
listed and in proper classification
categories to receive organs. Currently,
UNOS liver and thoracic Regional
Review Boards (RRBs) provide
retrospective review of designation of
status 1 and 2A patients for livers and
1A patients for hearts. The Department
will explore with the OPTN contractor
issues related to the conduct of
prospective and/or retrospective
reviews of all listings and changes in
status categories to assure that programs
are making appropriate classification
determinations. Reviews, prospective
and retrospective, might be performed
by existing OPTN RRBs. In addition, the
Secretary may ask independent third
parties, such as the Joint Commission on
the Accreditation of Health
Organizations (JCAHO), or Utilization
and Quality Control Peer Review
Organizations (PROs) established under
Part B of title XI of the Social Security
Act, to monitor the OPTN enforcement
system by independently conducting
audits of the work of the RRBs.
Incentives for High Performing OPOs
Concern has been expressed that, by
emphasizing broader sharing of organs,
the final rule might bring about reduced
organ donation. The Department
disagrees, and the IOM report found
some evidence that, where broader
sharing is currently occurring,
donations have increased. In response to
these concerns, however, HHS has

considered the possibility that positive
rewards might be offered for high
performing OPOs, to add to incentives
for organ donation. The Department
believes that high performance by OPOs
should be rewarded in a way that does
not disadvantage patients by
compromising one of the fundamental
objectives that the final rule is trying to
achieve—namely broader sharing of
organs. Therefore, the Department
encourages the OPTN to develop and
recommend to the Secretary policy
incentives to reward high-performing
OPOs. In addition, in response to
longer-standing concerns, HHS’ Health
Care Financing Administration (HCFA)
is reviewing the way it currently
measures OPO performance.
Policies to Address Socioeconomic
Barriers
Some in the transplant community
have expressed concern that the final
rule would require transplant hospitals
to make their own financial resources
available to pay for transplant and
follow-up care for patients unable to
pay. However, this was not the intention
of the April 2 final rule. The rule calls
on the OPTN Board of Directors to
recommend policies that would reduce
inequities in access resulting from
socioeconomic status and ensure that
the registration fee itself does not
represent a barrier to transplantation.
Registration Fees
One commenter objected to
Secretarial review of that portion of
registration fees paid by OPTN members
(and indirectly by patients and their
insurers) that represents expenditures
by the contractor that are not directly
related to the tasks performed under the
contracts with HHS. The final rule
specifies that the Secretary has oversight
of that portion of the registration fee
directly related to operation of the
OPTN.
Health Resources and Services
Administration (HRSA)–HCFA
Cooperation
A commenter noted the need for
increased coordination between HRSA
and HCFA on transplantation issues
within their respective areas of
responsibility. HRSA and HCFA have
pursued several cooperative efforts to
achieve increased organ donation, a goal
of the Administration’s National Organ
and Tissue Donation Initiative, which
was launched in December 1997. On
June 22, 1998, HCFA published a final
rule (42 CFR part 482) regarding
Medicare Hospital Conditions of
Participation, which requires hospitals
to refer all deaths and imminent deaths

to local OPOs and conduct donation
request training programs for
appropriate staff representatives. In
1999, HRSA and HCFA jointly
sponsored projects to encourage
collaboration between hospitals and
OPOs in effectively implementing this
regulation. HCFA’s responsibility for
OPO performance standard
establishment, certification and recertification of OPOs, and OPO waiver
request review involves close
cooperation with HRSA to identify
practices most likely to benefit donor
families and transplant patients, and
that impact current organ allocation
policy. In addition, HCFA and HRSA
are working together to enhance and
better coordinate collection, reporting,
and analysis of organ procurement and
transplant data in an effort to assure
optimum performance of the OPTN.
D. Data
Section 213 called for ‘‘timely and
accurate program-specific information
on the performance of transplant
programs.’’ The IOM report, in
reviewing 68,000 medical records, made
a significant contribution in the data
area, although the report also cited the
paucity of data available and
recommended improved data collection
and dissemination. In addition, UNOS
recently has added Internet-based
capability, both for providing
information to physicians and the
public and for collecting data from its
members.
Finally, HHS has completed new
transplant program-specific analyses
that show varying outcomes for patients
among different transplant hospitals.
Department staff analyzed OPTN patient
outcome data for liver and heart
transplants with respect to three critical
issues: (1) The likelihood that, having
been listed as a transplant candidate, a
patient will receive an organ within one
year; (2) the likelihood that a patient
will die within one year of listing while
awaiting transplantation; and, (3) the
likelihood that a patient will still be
alive one year after listing, irrespective
of whether he or she underwent a
transplant procedure. After risk
adjustment (i.e., adjustment for
differences in the mix of patients’ health
status from program to program), the
analyses revealed substantial differences
in outcomes from one transplant
program to another. The principal
findings for liver transplants illustrate
that:
• Ten percent of the programs have a
standardized risk-adjusted rate of
transplantation within one year of
listing of 71 percent or more; whereas,

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations
for another ten percent of the programs,
the rate is 25 percent or less;
• The likelihood of dying within one
year of listing while awaiting a
transplant ranges from less than 8
percent to more than 22 percent; and
• The likelihood of surviving one
year after listing as a transplant
candidate or a recipient ranges from
approximately 65 percent to almost 86
percent.
The analogous values for heart
transplants are 72 and 36 percent
(transplantation within one year of
listing), 9 and 23 percent (death within
one year of listing while awaiting a
transplant), 67 and 84 percent (survival
for one year after listing irrespective of
whether transplanted or not).
In the course of performing these
analyses, Department staff identified
gaps in the data currently collected by
the Scientific Registry—e.g., additional
clinical details about patients’
conditions at the time of listing (which
could improve risk adjustment) and
additional data on clinical
complications (which could help in
assessing quality of life following
transplantation). The Department has
provided these analyses to UNOS and
has encouraged it, in its management of
the OPTN and its operation of the
Scientific Registry, to broaden the scope
of data collection and make increased
use of program-specific performance
analyses. The analyses are included in
the U.S. Department of Health and
Human Services 1999 Report to
Congress on the Scientific and Clinical
Status of Organ Transplantation.
II. Public Comments
Between April 2 and September 16,
1998, we received a total of
approximately 2,500 comments on the
final rule. (Letters with petitions or with
form letters attached were counted as
one comment. HHS received a total of
approximately 20,000 form letters.) The
majority of the comments reflected
issues addressed in ‘‘Clarifications’’
above. This document includes changes
intended to make these issues clear.
Other issues raised by commenters were
discussed in the meetings conducted
this year pursuant to section 213 of the
Appropriation Act, and they are also
outlined above.
III. Changes in the Regulatory Text
As a result of the comments received,
the Department has made several
modifications to the final rule published
on April 2, 1998. Some changes have
been made to clarify the regulatory
language. Other revisions to the
regulatory text add provisions or modify

56655

requirements from the previously
published final rule.

3. Composition of OPTN Board of
Directors

1. Definition of Organ

The Department wishes to ensure
adequate patient, donor and family
representation on the OPTN Board of
Directors, while giving the OPTN
sufficient flexibility to constitute a
balanced and effective Board. Thus the
Department has included a requirement
under § 121.3(a) that the Board of
Directors shall include at least 25
percent transplant candidates,
transplant recipients, organ donors, and
family members. In response to
comments, the Department also has
revised § 121.3(a)(1) to enable the OPTN
to govern itself with greater flexibility
than was provided by the 1998 rule. The
revised language maintains the
requirement that the Board of Directors
include representatives of OPOs,
transplant centers, voluntary health
associations, transplant coordinators,
histocompatibility experts, other nonphysician transplant professionals, and
the general public, but does not
mandate a specific number of members
from each category. The Secretary
believes that the less prescriptive
language in this revision will better
allow the OPTN itself to determine the
appropriate size of, and representation
on, its Board of Directors, while
achieving a balance among physician,
patient, donor, family and other
representatives.
Section 121.3(a)(2) has been revised.
That paragraph prohibited those Board
members who were identified as
transplant recipients, transplant
candidates, organ donors, family
members, or members of the general
public to be employees of, or have
similar relationships with, specified
categories of institutional members
required to be on the Board. The revised
paragraph is more flexible, as described
more fully above.
As discussed above, § 121.3(a) has
been revised to require that
approximately 50 percent of the Board
members be transplant surgeons or
transplant physicians, rather than the
language of the April 2, 1998, rule
requiring no more than 50 percent, and
that at least 25 percent of its members
be transplant candidates, transplant
recipients, organ donors, and family
members. The comparable requirements
for the Executive Committee of the
Board have been similarly revised.
Transplant physicians or transplant
surgeons elected to the Board or
Executive Committee under other
categories must be counted toward the
requirements of these paragraphs of the
final rule.

The Department has deleted bone
marrow from the definition of organ in
§ 121.2 because it falls within the scope
of a different statutory authority.
Although the NOTA refers to bone
marrow for purposes of the Scientific
Registry, subsequent legislation
established a separate program to
address ‘‘unrelated’’ bone marrow
transplants. A commenter
recommended that the definition be
expanded to include intestine, stomach,
or a collection of human cells that
perform a vital function of an organ,
including any organ containing
vasculature that carries blood after
transplantation. In the Preamble to the
1998 rule, the Department stated: ‘‘The
inclusion of other organs, such as the
stomach and intestines, not only would
have an impact on other requirements in
these regulations such as the
development of allocation policies,
certification of designated transplant
programs, and establishment of training
requirements but also would affect OPO
requirements to procure these organs in
accordance with HCFA rules. Thus, the
Department believes it would be
premature for this rule to specify other
organs in addition to those already
named. Instead, the Department will
direct the OPTN contractor to consider
which organs or parts of organs, if any,
should be subject to OPTN policies, and
to submit recommendations to the
Secretary.’’ The Department’s position
on this issue remains unchanged.
2. National List
The term ‘‘national list’’ has been
replaced with ‘‘waiting list’’ in § 121.2,
and throughout the final rule. The term
‘‘national list’’ was incorporated into the
regulation to reflect statutory language
in section 372 of the Public Health
Service (PHS) Act, 42 U.S.C. 274, which
requires the OPTN to ‘‘establish a
national list of individuals who need
organs.’’ Current OPTN allocation
convention derives subordinate lists
from a single database and current
OPTN policy allocates zero-antigen
mismatched kidneys nationally, due to
scientifically demonstrated
improvements in patient and graft
survival resulting from this policy.
Furthermore, ischemic times and
patient outcomes make such an
approach appropriate in the case of
zero-antigen mismatched kidneys. If
supported by scientific evidence, the
Department has no objection to this
approach.

56656

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations

Furthermore, the requirement for a
two year term for Board members in
former § 121.3(a)(4) has been deleted.
Board members have diverse
backgrounds and will require different
periods of time to become familiar with
the complex issues coming before the
Board. Thus, we believe that it is
appropriate for the OPTN to determine
for itself the length of the term for Board
members, subject to Departmental
review.
4. Socioeconomic Issues
As articulated in the April 2, 1998,
rule, the Department is concerned that
all patients in the country have access
to transplantation and encourages the
OPTN to work toward this goal. Several
members of the transplant community,
however, commented that the
provisions of § 121.4 addressing
socioeconomic issues would require
transplant hospitals to make their own
financial resources available to pay for
transplantation and follow-up care for
patients unable to pay. In response to
these comments, the Department has
revised this section to specify that
paragraph (a)(3)(i) refers only to the
registration fee and has revised
paragraph (a)(3)(ii) to clarify that
resources for patients unable to pay
should be sought from all available
sources.
5. Secretarial Review of OPTN Policies
In response to comments asking
which OPTN policies are to be
submitted to the Secretary, the
Department has modified the language
of § 121.4(b)(2) to provide that the Board
of Directors is required to provide the
Secretary with proposed policies that
the OPTN recommends be enforceable
under § 121.10 (including allocation
policies) and others as specified by the
Secretary. As discussed above, the rule
has been revised to adopt the IOM’s
recommendation that the Advisory
Committee assist the Secretary in
reviewing OPTN policies and practices
as well as to indicate the purposes of the
Secretary’s review.
The timing requirement has also been
changed from 30 days to 60 days before
implementation of the proposed policy
to provide a more realistic estimate of
the time required for review by the
Advisory Committee and the public,
should such review be necessary.
6. Registration Fee
One commenter objected to
Secretarial review of the patient
registration fee, maintaining that this fee
is paid voluntarily by OPTN members
for the services provided to them by the
contractor. The Department agrees that

a portion of the current fee represents a
voluntary payment by OPTN members
to the contractor for services outside the
direct operation of the OPTN on behalf
of patients, while another portion
represents the payment provided by
patients and their insurers for the
operation of the OPTN system itself.
Consequently, the Department has
modified the language of § 121.5(c) to
indicate that the portion of the
registration fee subject to Secretarial
oversight is that portion directly related
to operation of the OPTN; any other fee
may only be charged on a voluntary
basis to OPTN members. In this regard,
the Department would interpret the
‘‘reasonable costs’’ for operating the
OPTN to include additional costs of
compliance under § 121.8(a)(7) and
reviews and enforcement under
§ 121.10.
7. Human Immunodeficiency Virus
(HIV)
Commenters suggested revising the
language of § 121.6(b) to authorize
transplantation of organs from HIV
positive donors to HIV positive
recipients. The Department has revised
§ 121.6(b) to reflect the language of the
statute. We note, however, that HCFA
regulations governing OPOs, at 42 CFR
486.306(q), require OPOs to screen
donors to ‘‘[e]nsure that appropriate
donor screening and infection tests,
consistent with the OPTN standards and
the CDC [Centers for Disease Control
and Prevention] guidelines * * * are
performed * * * to prevent the
acquisition of organs that are infected
with the etiologic agent for acquired
immune deficiency syndrome.’’ The
OPO regulations require that OPO donor
screening meet the two thresholds of the
OPTN standards as well as the CDC
guidelines. OPOs must comply with the
CDC ‘‘Guidelines for Preventing
Transmission of Human
Immunodeficiency Virus Through
Transplantation of Human Tissue and
Organs’’ as appended to the regulations
for OPOs (see 42 CFR part 486, Subpart
G, Appendix A). As a result, the OPO
regulations will still preclude
acquisition of an organ from an HIVpositive donor for transplantation. The
OPTN may propose standards
permitting such transplantation to the
Secretary for consideration and
potential change in existing CDC
guidelines.
8. Criteria for Listing Patients
The 1998 rule set as a performance
goal that the OPTN standardize
objective and measurable medical
criteria for including patients on the
waiting list. In drafting the language of

that section, the Department expected
that the criteria developed for adding
patients to the waiting list would
inherently contain criteria for removing
patients from the list. Commenters
pointed out that the rule should be
specific in this respect. The Department
adopted this suggested clarification in
§ 121.8(b)(1).
9. Organ Allocation
The Department received many
comments on this section, especially
former § 121.8(a). We have reorganized
this entire section for clarity and
addressed points raised by the IOM as
well as several issues raised by
commenters. Some commenters asked
that we clarify the OPTN’s ability to
have different allocation policies for
different types of organs (or
combinations of organs) to be
transplanted. Language to this effect is
now found in § 121.8(a)(4). The
Department wishes to emphasize that
this means that the OPTN may take a
different approach in defining priority
ranking under § 121.8(b)(2) for organs
like kidneys where the technology of
renal dialysis permits some flexibility in
determining the timing of a transplant.
Similarly, a different approach may also
be taken where such ‘‘rescue’’
techniques are available for other
organs. Such alternatives may be used,
consistent with sound medical
judgment.
Other commenters suggested that the
concepts of using sound medical
judgment, avoidance of futile
transplants or wastage of organs, and
promotion of the efficient use of organs
should be applicable to all the
performance goals. Language adopting
this suggestion is now found in
§ 121.8(a)(5).
We have added to § 121.8(a)(5) a
provision that allocation policy seek to
promote patient access to transplants,
an issue Congress asked the IOM to
address. As discussed above, we have
also added at § 121.8(a)(7) language to
promote compliance with and
enforcement of approved allocation
policies.
We have revised the discussion of
medical urgency now found in
§ 121.8(b)(2). We have made clear that
the need to rank patients or categories
of patients in order of decreasing
medical urgency only applies to
otherwise medically appropriate
candidates for transplants. This is
consistent with the provisions found in
§ 121.8(a) that require allocation
policies be developed in accordance
with sound medical judgment and
avoidance of futile transplants and
organ wastage.

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations
Some commenters suggested that the
rule was unclear as to how ‘‘medical
urgency’’ applies to kidney allocation
policy. We revised this section in
response to comments that the term
‘‘status categories,’’ as currently used for
liver and heart patients, is not used for
kidney patients. (Instead, a point system
is used to rank patients when an organ
becomes available.) The use of the term
‘‘patients or categories of patients’’ in
this section makes clear that ranking
patients rather than categories of
patients is permitted under this rule. As
discussed above, we intend for ranking
to be applied in the context of the
factors listed in § 121.8(a), especially in
accordance with sound medical
judgment. Therefore, we believe that
there may well be different approaches
to kidney allocation policy than those
for other types of organs, perhaps along
the lines of the current policies, which
take into account such factors as
immunologic compatibility between the
donor and patient, whether the patient’s
immune system is highly sensitized,
and other medical factors.
Commenters suggested that the
Department closely monitor the changes
to allocation policies made after the
initial reviews required under this
section to ensure that the new policies
are achieving the desired improvements
in the allocation system. The
Department intends to monitor the
effects of these changes closely and in
consultation with the OPTN. In addition
to this monitoring and consultation, the
Department will formally determine
whether further changes are necessary
six months and 12 months after the
changes to allocation policies made after
the initial reviews go into effect.
Finally, as discussed above, we have
given the OPTN additional flexibility
with respect to performance indicators,
including waiting times, in response
both to comments received and the IOM
report.
The Department wishes to emphasize,
however, that these changes are not
intended to limit the ability of the
OPTN to address special situations such
as the unique needs of young children.
10. Department of Veterans Affairs
Hospitals
The term ‘‘Dean’s Committee’’ has
been deleted from § 121.9(a)(3), as this
is not a term currently used by the
Department of Veterans Affairs.
Currently, the Department of Veterans
Affairs, Veterans Health Administration,
designates specific VA medical centers
to carry out organ transplantation. To
cover the possibility that transplants
may also be carried out in other Federal
hospitals, as well as those owned and

operated by the Department of Defense
(DoD), transplant programs in DoD or
other Federal hospitals have been added
to those eligible to receive organs for
transplantation under § 121.9(a).
11. Enforcement
Section 121.10(c)(1) has been edited
to clarify that appropriate enforcement
action may include termination of a
transplant program’s reimbursement
under Medicare and Medicaid. In
addition, the Department wishes to
clarify that the regulation permits the
OPTN to develop policies that will
contain lesser or intermediate level
sanctions that may be taken by the
OPTN, but these policies must first be
approved by the Secretary in order for
them to be enforceable.
12. Reporting Requirements
Section 121.11(b)(2) has been
amended to include transplant program
costs among the items to be reported by
transplant hospitals to the OPTN and
the Secretary. Although the language in
the previously published final rule was
sufficiently broad to permit the
Secretary to specify that cost
information be submitted, it was felt
that its specific inclusion in the rule
would ensure that such information
would be made available on a timely
basis when requested, consistent with
section 213. Because of the difficulty in
defining costs for these purposes, the
Department will accept measures of
resource utilization.
13. Effect of the Regulation on State
Laws (former § 121.12)
The inclusion of § 121.12 in the 1998
regulation was intended to be consonant
with longstanding Constitutional
principles regarding the relationship
between the Federal and State
governments. It reflected the HHS belief
that Congress intended the statutory
scheme it established under NOTA to
result ‘‘in the nationwide distribution of
organs equitably among transplant
patients.’’ Section 372(b)(2)(D) of the
Public Heath Service Act. Nevertheless,
because the Department views this
result as flowing from the statutory
scheme, the section of the regulation
articulating the Department’s views on
the matter is unnecessary as a legal
matter. Accordingly, § 121.12 has been
removed.
14. Advisory Committee on Organ
Transplantation
The Department intends to implement
the recommendation of the IOM, as
discussed above, to create an
independent, multidisciplinary
scientific advisory board which will

56657

assist the Secretary in, ‘‘ensuring that
the system of organ procurement and
transplantation is grounded on the best
available medical science and is as
effective and as equitable as possible.’’
Constitution of such an advisory
committee and its consultation by the
Secretary, as appropriate, in the words
of the IOM, ‘‘would also enhance public
confidence in the integrity and
effectiveness of the system.’’ The
Department has added a new § 121.12 to
provide for the establishment of an
Advisory Committee on Organ
Transplantation. The Committee, to be
established in accordance with the
Federal Advisory Committee Act [5
U.S.C. App.], will be available to the
Secretary to provide comments on
proposed OPTN policies and other
matters related to transplantation. The
Committee will be composed of
individuals drawn from diverse
backgrounds such as health care public
policy, transplantation medicine and
surgery, non-physician transplant
professions, biostatistics, immunology,
health economics, epidemiology,
bioethics, and law. As part of this
process of establishing the Committee,
the Secretary intends to solicit
nominations for Committee members
from the transplant community and the
general public.
IV. Impact Analyses
We have examined the impact of this
amendatory language as required by
Executive Order 12866, section 202 of
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4) and the Regulatory
Flexibility Act (RFA) (Pub. L. 96–354).
Executive Order 12866 directs agencies
to assess costs and benefits of available
regulatory alternatives and, when
regulation is necessary, to select
regulatory approaches that maximize
benefits. The Unfunded Mandates
Reform Act of 1995 also requires that
agencies prepare an assessment of
anticipated costs and benefits before
proposing any rule that may mandate an
annual expenditure by State, local, or
tribal governments of $100 million or
more.
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), if an action has a
significant economic effect on a
substantial number of small businesses,
the Secretary must specifically consider
the effects on small business entities
and analyze regulatory options that
could lessen the impact of the rule.
Section 1102(b) of the Social Security
Act requires us to prepare a regulatory
impact analysis for any regulation that
may have a significant impact on the
operations of a substantial number of
small rural hospitals.

56658

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations

The amendatory language set forth in
this document makes no changes that
have a significant economic effect on
State, local or tribal governments,
hospitals or patients; therefore, we
certify that no additional regulatory
analysis is required. We have also
concluded, based on the findings of the
Institute of Medicine and the General
Accounting Office under section 213(b),
discussed earlier in this Preamble, and
the Secretary certifies, that this
amendatory language would not have a
significant economic impact on a
substantial number of small entities;
therefore, a regulatory flexibility
analysis is not required.
We are also not preparing a rural
impact statement since we have
determined, and the Secretary certifies,
that this amendatory language would
not have a significant impact on the
operations of a substantial number of
small rural hospitals.
The earlier analyses from the April 2,
1998, final rule remain applicable to
that rule and are not altered by these
amendments.
List of Subjects in 42 CFR Part 121
Health care, Hospitals, Organ
transplantation, Reporting and
recordkeeping requirements.
Dated: October 13, 1999.
Claude Earl Fox,
Administrator, Health Resources and Services
Administration.
Approved: October 15, 1999.
Donna E. Shalala,
Secretary.

Accordingly, 42 CFR part 121 is
amended as follows:
PART 121—ORGAN PROCUREMENT
AND TRANSPLANTATION NETWORK
1. The authority citation for part 121
is revised to read as follows:
Authority: Sections 215, 371–376 of the
Public Health Service Act (42 U.S.C. 216,
273–274d); sections 1102, 1106, 1138 and
1871 of the Social Security Act (42 U.S.C.
1302, 1306, 1320b–8 and 1395hh).

2. Paragraph (b) of § 121.1 is revised
to read as follows:
§ 121.1

*

Applicability.

*
*
*
*
(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 the Social
Security Act, and organ procurement
organizations designated under section
1138(b) of the Social Security Act, are
subject to the requirements of this part.
3. Amend § 121.2 as follows:

a. Remove the definition for the
‘‘National list’’.
b. Amend the definition of ‘‘OPTN
computer match program’’ by revising
the words ‘‘national list’’ to read
‘‘waiting list’’.
c. Amend the definition of ‘‘Organ’’
by removing the words ‘‘and for the
purpose of the Scientific Registry, the
term also includes bone marrow’’.
d. Amend the definition of ‘‘Organ
procurement organization’’ by revising
the words ‘‘Section 1138(b)’’ to read
‘‘section 1138(b)’’.
e. Amend the definition of ‘‘Organ
procurement and transplantation
network or OPTN’’ by revising the
words ‘‘Section 372’’ to read ‘‘section
372’’.
f. Amend the definition of ‘‘Scientific
Registry’’ by revising the words
‘‘Section 373’’ to read ‘‘section 373’’.
g. Amend the definition of
‘‘Transplant candidate’’ by revising the
words national list’’ to read ‘‘waiting
list’’.
h. Add a definition for ‘‘Waiting list’’
in alphabetical order.
The addition reads as follows:
§ 121.2

*

Definitions.

*
*
*
*
Waiting list means the OPTN
computer-based list of transplant
candidates.
4. Amend § 121.3 as follows:
a. Revise the heading of paragraph (a).
b. Revise paragraph (a)(1).
c. Remove paragraph (a)(2).
d. Remove paragraph (a)(3).
e. Remove paragraph (a)(4).
f. Remove the heading of paragraph
(b).
g. Redesignate paragraph (b)(1) as
paragraph (a)(2) and revise it.
h. Redesignate paragraph (b)(2) as
paragraph (a)(3) and amend the newly
designated paragraph (a)(3) by removing
the paragraph heading.
i. Redesignate paragraph (b)(3) as
paragraph (a)(4) and amend newly
designated paragraph (a)(4) by removing
the paragraph heading.
j. In newly designated paragraph
(a)(4)(ii), revise the term ‘‘potential
transplant candidates’’ to read
‘‘transplant candidates, transplant
recipients, organ donors and family
members’’.
k. Remove paragraph (b)(4).
l. Redesignate paragraph (c) as
paragraph (b).
m. Redesignate paragraph (d) as
paragraph (c) and revise the word
‘‘Status’’ in the heading to read ‘‘status’’.
n. Redesignate paragraph (e) as
paragraph (d) and revise it.
The revisions read as follows:

§ 121.3

The OPTN.

(a) Organization of the OPTN. (1) The
OPTN shall establish a Board of
Directors of whatever size the OPTN
determines appropriate. The Board of
Directors shall include:
(i) Approximately 50 percent
transplant surgeons or transplant
physicians;
(ii) At least 25 percent transplant
candidates, transplant recipients, organ
donors and family members. These
members should represent the diversity
of the population of transplant
candidates, transplant recipients, organ
donors and family members served by
the OPTN including, to the extent
practicable, the minority and gender
diversity of this population. These
members shall not be employees of, or
have a similar relationship with OPOs,
transplant centers, voluntary health
organizations, transplant coordinators,
histocompatibility experts, or other nonphysician transplant professionals;
however, the Board may waive this
requirement for not more than 50
percent of these members; and
(iii) Representatives of OPOs,
transplant hospitals, voluntary health
associations, transplant coordinators,
histocompatibility experts, nonphysician transplant professionals, and
the general public.
(2) The Board of Directors shall elect
an Executive Committee from the
membership of the Board. The
Executive Committee shall include at
least one general public member, one
OPO representative, approximately 50
percent transplant surgeons and
transplant physicians, and at least 25
percent transplant candidates,
transplant recipients, organ donors, and
family members.
*
*
*
*
*
(d) Effective date. The organization
designated by the Secretary as the OPTN
shall have until June 30, 2000, or six
months from its initial designation as
the OPTN, whichever is later, to meet
the requirements of this section, except
that the Secretary may extend such
period for good cause.
5. Amend § 121.4 as follows:
a. Revise paragraph (a)(3)(i).
b. Revise paragraph (a)(3)(ii).
c. Revise paragraph (b)(2).
d. Revise paragraph (c).
e. Revise paragraph (d).
f. Amend paragraph (e) introductory
text by adding the word ‘‘shall’’ after the
words ‘‘implement policies and’’, and
by revising the word ‘‘them.’’ in
paragraph (e)(1) to read ‘‘them; and’’.
The revisions read as follows:

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations
§ 121.4. OPTN policies: Secretarial review
and appeals.

(a) * * *
(3) * * *
(i) Ensuring that payment of the
registration fee is not a barrier to listing
for patients who are unable to pay the
fee;
(ii) Procedures for transplant hospitals
to make reasonable efforts to obtain
from all available sources, financial
resources for patients unable to pay
such that these patients have an
opportunity to obtain a transplant and
necessary follow-up care;
*
*
*
*
*
(b) * * *
(2) Provide to the Secretary, at least 60
days prior to their proposed
implementation, proposed policies it
recommends to be enforceable under
§ 121.10 (including allocation policies).
These policies will not be enforceable
until approved by the Secretary. The
Board of Directors shall also provide to
the Secretary, at least 60 days prior to
their proposed implementation,
proposed policies on such other matters
as the Secretary directs. The Secretary
will refer significant proposed policies
to the Advisory Committee on Organ
Transplantation established under
§ 121.12, and publish them in the
Federal Register for public comment.
The Secretary also may seek the advice
of the Advisory Committee on Organ
Transplantation established under
§ 121.12 on other proposed policies, and
publish them in the Federal Register for
public comment. The Secretary will
determine whether the proposed
policies are consistent with the National
Organ Transplant Act and this part,
taking into account the views of the
Advisory Committee and public
comments. Based on this review, the
Secretary may provide comments to the
OPTN. If the Secretary concludes that a
proposed policy is inconsistent with the
National Organ Transplant Act or this
part, the Secretary may direct the OPTN
to revise the proposed policy consistent
with the Secretary’s direction. If the
OPTN does not revise the proposed
policy in a timely manner, or if the
Secretary concludes that the proposed
revision is inconsistent with the
National Organ Transplant Act or this
part, the Secretary may take such other
action as the Secretary determines
appropriate, but only after additional
consultation with the Advisory
Committee on the proposed action.
(c) The OPTN Board of Directors shall
provide the membership and the
Secretary with copies of its policies as
they are adopted, and make them
available to the public upon request.

The Secretary will publish lists of OPTN
policies in the Federal Register,
indicating which ones are enforceable
under § 121.10 or subject to potential
sanctions of section 1138 of the Social
Security Act. The OPTN shall also
continuously maintain OPTN policies
for public access on the Internet,
including current and proposed
policies.
(d) Any interested individual or entity
may submit to the Secretary in writing
critical comments related to the manner
in which the OPTN is carrying out its
duties or Secretarial policies regarding
the OPTN. Any such comments shall
include a statement of the basis for the
comments. The Secretary will seek, as
appropriate, the comments of the OPTN
on the issues raised in the comments
related to OPTN policies or practices.
Policies or practices that are the subject
of critical comments remain in effect
during the Secretary’s review, unless the
Secretary directs otherwise based on
possible risk to the health of patients or
to public safety. The Secretary will
consider the comments in light of the
National Organ Transplant Act and the
regulations under this part and may
consult with the Advisory Committee
on Organ Transplantation established
under § 121.12. After this review, the
Secretary may:
(1) Reject the comments;
(2) Direct the OPTN to revise the
policies or practices consistent with the
Secretary’s response to the comments;
or
(3) Take such other action as the
Secretary determines appropriate.
*
*
*
*
*
§ 121.5

[Amended]

6. Amend § 121.5 as follows:
a. In paragraph (a), add the words‘‘,
consistent with the OPTN’s criteria
under § 121.8(b)(1),’’ after the word
‘‘individuals’’.
b. In paragraph (b), revise the words
‘‘national list’’ to read ‘‘waiting list’’.
c. In paragraph (c), revise the words
‘‘national list’’ to read ‘‘waiting list’’ and
add the phrase ‘‘calculated to cover
(together with contract funds awarded
by the Secretary) the reasonable costs of
operating the OPTN and shall be’’ after
the words ‘‘amount of such fee shall be’.
7. Paragraph (b) of § 121.6 is revised
to read as follows:
§ 121.6

*

Organ procurement.

*
*
*
*
(b) HIV. The OPTN shall adopt and
use standards for preventing the
acquisition of organs from individuals
known to be infected with human
immunodeficiency virus.
*
*
*
*
*

§ 121.7

56659

[Amended]

8. Paragraph (d) of § 121.7 is amended
by revising the words ‘‘paragraph (b) of
this section’’ to read ‘‘paragraph (b)(2) of
this section’.
9. Revise § 121.8 to read as follows:
§ 121.8

Allocation of organs.

(a) Policy development. The Board of
Directors established under § 121.3 shall
develop, in accordance with the policy
development process described in
§ 121.4, policies for the equitable
allocation of cadaveric organs among
potential recipients. Such allocation
policies:
(1) Shall be based on sound medical
judgment;
(2) Shall seek to achieve the best use
of donated organs;
(3) Shall preserve the ability of a
transplant program to decline an offer of
an organ or not to use the organ for the
potential recipient in accordance with
§ 121.7(b)(4)(d) and (e);
(4) Shall be specific for each organ
type or combination of organ types to be
transplanted into a transplant candidate;
(5) Shall be designed to avoid wasting
organs, to avoid futile transplants, to
promote patient access to
transplantation, and to promote the
efficient management of organ
placement;
(6) Shall be reviewed periodically and
revised as appropriate;
(7) Shall include appropriate
procedures to promote and review
compliance including, to the extent
appropriate, prospective and
retrospective reviews of each transplant
program’s application of the policies to
patients listed or proposed to be listed
at the program; and
(8) Shall not be based on the
candidate’s place of residence or place
of listing, except to the extent required
by paragraphs (a)(1)–(5) of this section.
(b) Allocation performance goals.
Allocation policies shall be designed to
achieve equitable allocation of organs
among patients consistent with
paragraph (a) of this section through the
following performance goals:
(1) Standardizing the criteria for
determining suitable transplant
candidates through the use of minimum
criteria (expressed, to the extent
possible, through objective and
measurable medical criteria) for adding
individuals to, and removing candidates
from, organ transplant waiting lists;
(2) Setting priority rankings
expressed, to the extent possible,
through objective and measurable
medical criteria, for patients or
categories of patients who are medically
suitable candidates for transplantation
to receive transplants. These rankings

56660

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations

shall be ordered from most to least
medically urgent (taking into account,
in accordance with paragraph (a) of this
section, and in particular in accordance
with sound medical judgment, that life
sustaining technology allows alternative
approaches to setting priority ranking
for patients). There shall be a sufficient
number of categories (if categories are
used) to avoid grouping together
patients with substantially different
medical urgency;
(3) Distributing organs over as broad
a geographic area as feasible under
paragraphs (a)(1)–(5) of this section, and
in order of decreasing medical urgency;
and
(4) Applying appropriate performance
indicators to assess transplant program
performance under paragraphs (c)(2)(i)
and (c)(2)(ii) of this section and
reducing the inter-transplant program
variance to as small as can reasonably
be achieved in any performance
indicator under paragraph (c)(2)(iii) of
this section as the Board determines
appropriate, and under paragraph
(c)(2)(iv) of this section. If the
performance indicator ‘‘waiting time in
status’’ is used for allocation purposes,
the OPTN shall seek to reduce the intertransplant program variance in this
indicator, as well as in other selected
performance indicators, to as small as
can reasonably be achieved, unless to do
so would result in transplanting less
medically urgent patients or less
medically urgent patients within a
category of patients.
(c) Allocation performance indicators.
(1) Each organ-specific allocation policy
shall include performance indicators.
These indicators must measure how
well each policy is:
(i) Achieving the performance goals
set out in paragraph (b) of this section;
and
(ii) Giving patients, their families,
their physicians, and others timely and
accurate information to assess the
performance of transplant programs.
(2) Performance indicators shall
include:
(i) Baseline data on how closely the
results of current allocation policies
approach the performance goals
established under paragraph (b) of this
section;
(ii) With respect to any proposed
change, the amount of projected
improvement in approaching the
performance goals established under
paragraph (b) of this section;
(iii) Such other indicators as the
Board may propose and the Secretary
approves; and
(iv) Such other indicators as the
Secretary may require.

(3) For each organ-specific allocation
policy, the OPTN shall provide to the
Secretary data to assist the Secretary in
assessing organ procurement and
allocation, access to transplantation, the
effect of allocation policies on programs
performing different volumes of
transplants, and the performance of
OPOs and the OPTN contractor. Such
data shall be required on performance
by organ and status category, including
program-specific data, OPO-specific
data, data by program size, and data
aggregated by organ procurement area,
OPTN region, the Nation as a whole,
and such other geographic areas as the
Secretary may designate. Such data
shall include the following measures of
inter-transplant program variation: riskadjusted total life-years pre-and posttransplant, risk-adjusted patient and
graft survival rates following
transplantation, risk-adjusted waiting
time and risk-adjusted transplantation
rates, as well as data regarding patients
whose status or medical urgency was
misclassified and patients who were
inappropriately kept off a waiting list or
retained on a waiting list. Such data
shall cover such intervals of time, and
be presented using confidence intervals
or other measures of variance, as may be
required to avoid spurious results or
erroneous interpretation due to small
numbers of patients covered.
(d) Transition patient protections.—
(1) General. When the OPTN revises
organ allocation policies under this
section, it shall consider whether to
adopt transition procedures that would
treat people on the waiting list and
awaiting transplantation prior to the
adoption or effective date of the revised
policies no less favorably than they
would have been treated under the
previous policies. The transition
procedures shall be transmitted to the
Secretary for review together with the
revised allocation policies.
(2) Special rule for initial revision of
liver allocation policies. When the
OPTN transmits to the Secretary its
initial revision of the liver allocation
policies, as directed by paragraph (e)(1)
of this section, it shall include transition
procedures that, to the extent feasible,
treat each individual on the waiting list
and awaiting transplantation on October
20, 1999 no less favorably than he or she
would have been treated had the revised
liver allocation policies not become
effective. These transition procedures
may be limited in duration or applied
only to individuals with greater than
average medical urgency if this would
significantly improve administration of
the list or if such limitations would be
applied only after accommodating a
substantial preponderance of those

disadvantaged by the change in the
policies.
(e) Deadlines for initial reviews. (1)
The OPTN shall conduct an initial
review of existing allocation policies
and, except as provided in paragraph
(e)(2) of this section, no later than
November 16, 2000 shall transmit initial
revised policies to meet the
requirements of paragraphs (a) and (b) of
this section, together with supporting
documentation to the Secretary for
review in accordance with § 121.4.
(2) No later than February 15, 2000
the OPTN shall transmit revised policies
and supporting documentation for liver
allocation to meet the requirements of
paragraphs (a) and (b) of this section to
the Secretary for review in accordance
with § 121.4. The OPTN may transmit
these materials without seeking further
public comment under § 121.4(b).
(f) Secretarial review of policies,
performance indicators, and transition
patient protections. The OPTN’s
transmittal to the Secretary of proposed
allocation policies and performance
indicators shall include such supporting
material, including the results of modelbased computer simulations, as the
Secretary may require to assess the
likely effects of policy changes and as
are necessary to demonstrate that the
proposed policies comply with the
performance indicators and transition
procedures of paragraphs (c) and (d) of
this section.
(g) Variances. The OPTN may
develop, in accordance with § 121.4,
experimental policies that test methods
of improving allocation. All such
experimental policies shall be
accompanied by a research design and
include data collection and analysis
plans. Such variances shall be time
limited. Entities or individuals objecting
to variances may appeal to the Secretary
under the procedures of § 121.4.
(h) Directed donation. Nothing in this
section shall prohibit the allocation of
an organ to a recipient named by those
authorized to make the donation.
10. Amend § 121.9 as follows:
a. Amend paragraph (a)(1) by
removing the words ‘‘and Medicaid’’
after the word ‘‘Medicare’’.
b. Amend paragraph (a)(2)(vi) by
adding a comma after the word
‘‘radiology’’.
c. Amend paragraph (a)(2)(vii) by
adding a comma after the word
‘‘recipients’’.
d. Revise paragraph (a)(3).
The revision reads as follows:
§ 121.9 Designated transplant program
requirements.

(a) * * *
(3) Be a transplant program in a
Department of Veterans Affairs,

Federal Register / Vol. 64, No. 202 / Wednesday, October 20, 1999 / Rules and Regulations
Department of Defense, or other Federal
hospital.
*
*
*
*
*
§ 121.10

[Amended]

11. Amend paragraph (c)(1) of
§ 121.10 by removing the word ‘‘or’’
before the words ‘‘termination of an
OPO’s reimbursement’’, and by adding
the words ‘‘, or such other compliance
or enforcement measures contained in
policies developed under § 121.4’’ after
the words ‘‘Social Security Act’’.
12. Amend § 121.11 as follows:
a. Revise paragraph (a)(1)(i) by
removing the word ‘‘national’’ after the
word ‘‘computerized’’.
b. Revise paragraph (b)(1)(iv).
c. Amend paragraph (b)(2) by adding
the words ‘‘costs and’’ before the word
‘‘performance’’.
The revision reads as follows:
§ 121.11 Record maintenance and
reporting requirements.

*

*
*
(b) * * *
(1) * * *

*

*

(iv) Make available to the public
timely and accurate program-specific
information on the performance of
transplant programs. This shall include
free dissemination over the Internet, and
shall be presented, explained, and
organized as necessary to understand,
interpret, and use the information
accurately and efficiently. These data
shall be updated no less frequently than
every six months (or such longer period
as the Secretary determines would
provide more useful information to
patients, their families, and their
physicians), and shall include riskadjusted probabilities of receiving a
transplant or dying while awaiting a
transplant, risk-adjusted graft and
patient survival following the
transplant, and risk-adjusted overall
survival following listing for such
intervals as the Secretary shall
prescribe. These data shall include
confidence intervals or other measures
that provide information on the extent
to which chance may influence
transplant program-specific results.

56661

Such data shall also include such other
cost or performance information as the
Secretary may specify, including but not
limited to transplant program-specific
information on waiting time within
medical status, organ wastage, and
refusal of organ offers. These data shall
also be presented no more than six
months later than the period to which
they apply;
*
*
*
*
*
13. § 121.12 is revised to read as
follows:
§ 121.12 Advisory Committee on Organ
Transplantation.

The Secretary will establish,
consistent with the Federal Advisory
Committee Act, the Advisory Committee
on Organ Transplantation. The
Secretary may seek the comments of the
Advisory Committee on proposed OPTN
policies and such other matters as the
Secretary determines.
[FR Doc. 99–27456 Filed 10–18–99; 9:46 am]
BILLING CODE 4160–15–P