[Federal Register Volume 63, Number 119 (Monday, June 22, 1998)]
[Rules and Regulations]
[Pages 33856-33875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16490]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 482
[HCFA-3005-F]
RIN: 0938-AI95
Medicare and Medicaid Programs; Hospital Conditions of
Participation; Identification of Potential Organ, Tissue, and Eye
Donors and Transplant Hospitals' Provision of Transplant-Related Data
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
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SUMMARY: This final rule addresses only provisions relating to organ
donation and transplantation. It imposes several requirements a
hospital must meet that are designed to increase organ donation. One of
these requirements is that a hospital must have an agreement with the
Organ Procurement Organization (OPO) designated by the Secretary, under
which the hospital will contact the OPO in a timely manner about
individuals who die or whose death is imminent in the hospital. The OPO
will then determine the individual's medical suitability for donation.
As well, the hospital must have an agreement with at least one tissue
bank and at least one eye bank to cooperate in the retrieval,
processing, preservation, storage, and distribution of tissues and
eyes, as long as the agreement does not interfere with organ donation.
The final rule requires a hospital to ensure, in collaboration with the
OPO with which it has an agreement, that the family of every potential
donor is informed of its option to donate organs or tissues or not to
donate. Under the final rule, hospitals must work with the OPO and at
least one tissue bank and one eye bank in educating staff on donation
issues, reviewing death records to improve identification of potential
donors, and maintaining potential donors while necessary testing and
placement of organs and tissues take place. In addition, transplant
hospitals must provide organ-transplant-related data, as requested by
the OPTN, the Scientific Registry, and the OPOs. The hospital must also
provide, if requested, such data directly to the Department.
DATES: These regulations are effective on August 21, 1998.
FOR FURTHER INFORMATION CONTACT: Marcia Newton, (410) 786-5265.
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I. Background
A. Key Statutory Provisions
Sections 1861(e) (1) through (8) of the Social Security Act (the
Act) provide that a hospital participating in the Medicare program must
meet certain specified requirements. Section 1861(e)(9) of the Act
specifies that a hospital must also meet such other requirements as the
Secretary finds necessary in the interest of the health and safety of
the hospital's patients.
[[Page 33857]]
Under this authority, the Secretary has established in regulations the
requirements that a hospital must meet to participate in Medicare (42
CFR Part 482, Conditions of Participation for Hospitals).
Section 1905(a) of the Act provides that Medicaid payments must be
applied to hospital services. Under regulations at 42 CFR
440.10(a)(3)(iii), hospitals generally are required to meet the
Medicare Conditions of Participation in order to participate in
Medicaid.
Section 1138 of the Act provides that a hospital participating in
Medicare must establish written protocols for the identification of
potential organ donors that (1) ensure that families of potential organ
donors are made aware of the option of organ or tissue donation and
their option to decline donation, (2) encourage discretion and
sensitivity with respect to the circumstances, views, and beliefs of
those families, and (3) require that an organ procurement agency
designated by the Secretary be notified of potential organ donors.
B. Why the Hospital/OPO Relationship Must Improve
An estimated 12,000 to 15,000 deaths occurring in the United States
every year could yield suitable donor organs. [Gortmaker SL, Beasley
CL, et al. ``Organ donor potential and performance: Size and nature of
the organ donor shortfall.'' Critical Care Medicine (1996); 24 432-39]
However, in 1997, only 5,475 of these deaths resulted in the donation
of an organ.
As progress has been made in the science of transplantation, the
gap has widened considerably between the number of individuals who
could benefit from transplants and the number of organs available for
transplantation. In the twelve years since the enactment of Section
1138 of the Act, the number of organ donors has increased by only 33
percent, while the transplant waiting list has grown by 250 percent. As
of June 3, 1998, 56,222 individuals were on the waiting list for a
transplant, but the number of organs transplanted from cadaveric donors
in 1997 numbered only 17,032. Preliminary 1997 data compiled by the
Organ Procurement and Transplantation Network contractor indicates that
the number of donors (5,475 donors in 1997) increased by only 54 donors
or by less than one percent over the 5,421 donors in 1996.
A 1993 Gallup poll showed that 85 percent of Americans support the
general concept of organ donation and 69 percent would be somewhat or
very likely to donate their own organs. [The Gallup Organization, Inc.
``The American Public's Attitudes Toward Organ Donation and
Transplantation,'' A survey prepared by the Gallup Organization, Inc.
for The Partnership for Organ Donation, Boston, Massachusetts,
(February 1993)] Information from a number of recent studies and from
States that have passed organ donor legislation has given us a clearer
understanding of the reasons for the disparity between the strong
public support for the concept of organ donation and the apparent
failure of the current system to convert potential donors to actual
donors. We have used this information to guide us in promulgating the
final rule.
II. Notice of Proposed Rulemaking
On December 19, 1997, a proposed rule, ``Medicare and Medicaid
Programs; Hospital Conditions of Participation; Provider Agreements and
Supplier Approval'' [HCFA-3745-P] was published in the Federal Register
[62 FR 66726]. The proposed rule extensively revised the current
conditions of participation for hospitals. Among the proposed changes
were provisions designed to increase the number of organs available for
transplantation.
The proposed rule was developed in response to issues raised during
public hearings held by the Department on December 11 through 13, 1996,
to examine the allocation policies for liver transplantation and to
receive comments regarding methods to increase organ donation. The
comments we received at the public hearings highlighted that there is a
critical shortage of organs available for transplantation and some of
the options available to alleviate the shortage.
Every day an estimated 10 individuals in the United States die
because organs are not available to save their lives. This fact gave
particular urgency to publication of a final rule covering the
provisions of the proposed rule designed to increase donation and
transplantation. Therefore, we have extracted those provisions from the
proposed rule and are publishing them here, with some modifications, as
a final rule. We will be publishing other provisions of the proposed
rule as a final rule at a later date.
III. Analysis of and Responses to Public Comments
We received a total of 150 comments on these provisions from
hospitals, OPOs, tissue and eye banks, professional organizations,
transplant organizations, medical practitioners, donor family
organizations, and other organizations and individuals. A summary of
the major issues and our responses follow:
Impact on Tissue and Eye Donation
Comment: Several commenters said the regulation should not require
that hospitals contact OPOs exclusively about potential donors,
including potential tissue and eye donors. Commenters voiced concern
that calls about potential tissue donors would not be handled by the
OPOs satisfactorily.
Response: The proposed rule did not include a requirement that all
calls be referred exclusively to an OPO. However, the final rule does
include a requirement that all deaths must be referred to the OPO or a
third party designated by the OPO, using protocols developed by the
OPO. In the absence of separate arrangements between the hospital and a
tissue bank and an eye bank, the OPO will identify and refer potential
tissue and eye donors using protocols developed in consultation with
the tissue bank and eye bank. The final rule also authorizes a hospital
to notify a tissue or eye bank directly about potential tissue or eye
donors. We believe these requirements will assure that the interests of
the tissue and eye banks are considered and will encourage all parties
to reach a consensus that will honor the hospital's need for a referral
process that is not burdensome for hospital staff.
Comment: One commenter stated that the proposed rule does not
address ways to effectively ensure OPO and hospital cooperation with
the eye and tissue banks in their communities. Many commenters
questioned why the OPOs should be the ``gatekeepers'' for all donations
and predicted this would adversely impact tissue and eye donations. One
commenter suggested all language referring to tissues or eyes be
removed from the text of the regulation, so that the rule applies only
to organ donation. The commenter expressed the belief that expecting
OPOs to serve as the focal point for both organ and tissue donation
places too great a burden on OPOs.
Response: In promulgating a rule designed to increase organ
donation, we wish to avoid the possibility that the rule will have an
adverse impact on tissue and eye donation and retrieval. In the
proposed rule, we stated our expectation that hospitals, OPOs, eye and
tissue banks would work cooperatively and effectively to facilitate and
enhance organ, tissue, and eye donation. However, we noted the
considerable local variation in arrangements and how they might be
modified under the proposed changes. We specifically requested comments
on
[[Page 33858]]
how the proposed rule might impact tissue donation and suggestions for
measures we can take to maximize donation of organs, tissues, and eyes.
We received many comments from tissue and eye banks, their
professional organizations, and individuals active in this area. Some
of these commenters stated that in communities where the relationship
among the hospitals, OPOs, and the tissue and eye banks is
collaborative in nature, the system works well. Many described
communities where a single, toll-free telephone number has been
established for hospitals to call for referrals of potential organ,
tissue, and eye donors. The entity taking the call (whether the OPO or,
in some cases, a commercial entity under contract) screens the calls
and refers them appropriately and expeditiously. However, other
commenters described communities where some hospitals have never
referred a single potential donor and where the relationship between
the OPO and the tissue and eye banks is acrimonious and antagonistic.
The final rule preserves the flexibility of hospitals, tissue
banks, and eye banks to enter into arrangements that do not involve the
OPO. However, the final rule makes OPOs the default ``gatekeepers'' for
referral of potential tissue and eye donors in the absence of other
arrangements. Therefore, we have included in the final rule a
requirement that the OPO consult with the tissue and eye bank(s) in
establishing protocols for the identification and referral of potential
tissue and eye donors. We have also added language to ensure that
hospitals work cooperatively with a tissue bank and an eye bank, as
well as the OPO, in educating hospital staff, reviewing death records,
and maintaining potential donors. We will be monitoring the progress of
the cooperative relationships envisioned by this rule to ensure that
the gatekeeper role described does not harm tissue and eye donation.
Comment: Many commenters suggested expanding the regulation so that
tissues and eyes are included. One commenter pointed out that there is
a critical shortage of tissues for transplant in the United States. For
example, patients who await a long bone allograft for treatment of
cancer must often wait months for a transplant or resort to amputation.
Several commenters said that only 8 percent of needed tissue is
currently obtained. Other commenters added that we should include in
the final regulation definitions for tissues and eyes.
Response: We agree there is a critical need for tissues and corneas
as well as solid organs. We have, therefore, modified the text of this
regulation to ensure that tissue and eye banks participate in the local
decision-making process. We believe that the addition of these
references will increase donations for tissues and eyes as well as
solid organs. The procurement and transplantation of tissues and eyes,
however, is not regulated by HCFA; therefore, we are not including
definitions of these terms in the final rule. The regulation requires
OPOs to consult with the designated tissue and eye bank in defining
tissue and eye donor and we will rely upon the OPOs, tissue banks, and
eye banks to define tissues and eyes as well.
Comment: Some commenters suggested that the rule discourage
excessive fees charged by OPOs for referral of tissue donations to
tissue and eye banks. Some commenters said that some OPOs may begin
referring their donor calls to the highest cost reimburser, with eye
and tissue banks forced to try to outbid each other for tissues. One
commenter was concerned about donor family and public perceptions that
might negatively affect willingness to donate. Other commenters
expressed concern that high referral fees would put eye banks out of
business.
Response: Our policies defining reimbursement for OPOs extend only
to those activities in which the OPO engages on behalf of an eligible
Medicare or Medicaid beneficiary, and are limited to reasonable costs.
Therefore, any expenses incurred by an OPO, or any charges which may be
made to payers other than HCFA, will not be addressed here. We have,
however, expressly preserved hospitals' rights to enter into agreements
with tissue and eye banks so long as those arrangements do not
interfere with an OPO's efforts to recover solid organs. We would
anticipate that tissue and eye banks that encounter fees they consider
excessive would have the opportunity to address this issue during the
establishment of donor and referral protocols.
Comment: One commenter stated we should clarify that our intent is
not to disrupt existing contracts between hospitals and tissue banks.
Response: It is certainly not our intent to disrupt contracts
between hospitals and tissue banks or hospitals and eye banks. We
believe the regulation's requirement which authorizes agreements
between the hospital and a tissue bank and an eye bank and its emphasis
on collaboration among hospitals, OPOs, and tissue and eye banks will
increase tissue and eye donation without disrupting contracts.
Referral Systems
Comment: Some commenters expressed concern that the proposed rule
would mean elimination of current, successful community systems for
referral of organ, tissue, and eye donors.
Response: Our intent in promulgating this rule is certainly not to
disturb successful community referral systems, and we would urge
hospitals and OPOs not to abandon them. Therefore, we have revised the
rule to clarify that it does not preclude such systems. The final rule
permits the hospital to refer potential donors to a third party
designated by the OPO and to continue successful arrangements with
tissue banks and eye banks. In addition, we encourage OPOs and
hospitals, in consultation with tissue and eye banks, to use this
opportunity to improve upon current referral systems to maximize not
only organ donation but tissue and eye donation as well.
Comment: Many commenters suggested a system whereby all referral
calls go to a single non-proprietary answering service or a referral
system operated by one of the organ or tissue agencies and supported by
all. They pointed out that the process is more successful when
hospitals are required to make a single phone call, rather than
contacting multiple agencies about a potential donor. One commenter
added that hospitals and grieving families should not be burdened with
two distinct but parallel operating communications regarding donations.
One large, nationwide tissue bank suggested that all referrals be made
either to the OPO or a non-proprietary service. One eye bank commented
that eye banks in areas with a non-proprietary phone number experience
an increase in donations. In contrast, another tissue bank suggested a
two-call system which is used in its State. In this State, hospitals
are required to contact the OPO on all brain deaths. All other deaths
are reported to a referral agency, based on a plan agreed to by the
hospital and all other agencies.
Response: Before responding to the comment, we want to clarify that
this rule requires hospitals to notify OPOs or a third party designated
by the OPO, of individuals whose death is imminent of who have died in
the hospital. Some commenters make reference to ``brain death'' donors,
meaning heart beating donors who have been declared brain dead. This
regulation does not exclude the reporting of non-heartbeating deaths.
Hospitals must report both brain dead and cadaveric potential donors.
[[Page 33859]]
We have added language to the text of the regulation to clarify that
referral of phone calls to a third party entity designated by the OPO
is not precluded. Anecdotal evidence indicates that a one-phone-call
referral process may increase organ donations, as well as tissue and
eye donations. Logically, it would seem that a system that makes it
possible for a hospital to refer potential donors with a single phone
call would make hospital compliance easier and, therefore, more likely.
We would urge communities to explore this option.
However, regardless of how the referral by the hospital is
accomplished, we would also urge that protocols ensure that families of
potential donors are approached about donation by a single agency
(either the OPO, a tissue bank, or an eye bank) in collaboration with
hospital staff. For example, Florida donation legislation provides that
the OPO must be given the opportunity to approach the families of
suitable vascular organ donors. OPOs may represent the tissue and eye
bank. Under the Florida law, the tissue bank must be given the
opportunity to approach the family of suitable tissue donors if the OPO
has not already approached the family. Eye banks must be given the
opportunity to approach the family of suitable eye donors if the OPO or
a tissue bank has not already approached the family.
Comment: Several commenters suggested we strengthen the regulation
by adopting a routine referral approach which requires referral of all
patient deaths to OPOs. Commenters pointed to the success of the
Pennsylvania routine referral law and predicted similar increases in
donation rates if a nationwide routine referral approach were to be
adopted. Commenters gave the following reasons for supporting routine
referral: (1) A clear standard is established for hospitals regarding
when referrals must be made to the OPO; (2) allows early intervention
by the OPO to guide the organ and tissue process to ensure a successful
outcome; (3) ensures that the hospital will not erroneously assume that
a potential donor is too old or has a medical condition that precludes
donation; (4) removes from hospitals the burden of keeping abreast of
changing standards for donor screening and suitability criteria; (5)
minimizes regional differences in organ procurement and transplant
waiting times, and (6) facilitates compliance by hospital systems whose
member hospitals are served by more than one OPO. However, many
commenters who supported routine referral suggested some flexibility be
built into the regulation in consideration of resource limitations or
local circumstances. For example, commenters suggested that deaths of
individuals above a certain age be excluded from routine referral.
Response: We agree with the commenters who support routine referral
of all deaths and have adopted their recommendation in this regulation.
We believe that the experiences of States with routine referral
legislation have demonstrated that referral of all deaths is the single
most critical factor in increasing organ donation rates. Referral of
all deaths assures that determination of medical suitability is made by
the OPOs, because OPOs are the entities with knowledge of transplant
hospitals' donor suitability criteria.
However, we have not adopted the recommendations of those who
advised us to give OPOs the discretion to exclude certain categories of
deaths from the requirement for routine referral. Referral of all
deaths, with no exclusions, eliminates the need for OPOs and hospitals
to rewrite referral protocols and reeducate hospital staff whenever
transplant hospitals' donor suitability criteria change. It is also
less difficult for HCFA to monitor hospital compliance if there are no
exclusions. Finally, it is important to note that many OPOs will be
screening donors for tissue and eye donation, and tissue and eye banks
often have criteria for donation that differ significantly from the
criteria for organ donation. For example, in 1997, only 6.4 percent of
organ donors were over the age of 65. The Eye Bank Association of
America reports however, that more than 28 percent of all eye donors in
1997 were over the age of 70.
Comment: Some commenters urged us not to adopt a routine referral
approach. Commenters stated that routine referral will not work where
relationships between OPOs and hospitals are, at best, uncooperative.
Other commenters cited the burden and cost to hospitals and OPOs of
making or receiving many unproductive calls.
Response: We believe routine referral is workable and will increase
organ donation. We hope that all OPOs and hospitals will be encouraged
by this regulation to develop relationships that increase organ and
tissue donation. If they are not able to develop such relationships,
however, a hospital may choose to seek waiver to associate with another
OPO, or the original OPO may find itself unable to meet HCFA
certification standards and be replaced by an OPO better able to
develop the kind of relationships that lead to greater organ and tissue
recovery.
A 1988 commentary published in the Journal of the American Medical
Association states that the cooperation of the medical professions is
the primary factor limiting the supply of transplantable organs. The
author suggests that routine referral ``would not solve all the
problems of professional cooperation, but it would ameliorate a key one
and open the bottleneck that presently constrains the supply of
organs.'' [Prottas, J. ``Shifting Responsibilities in Organ
Procurement: A Plan for Routine Referral.'' Journal of the American
Medical Association. 1988;260:6]
We do not expect the cost to hospitals of referring all deaths to
be significant. As discussed in the Regulatory Impact Statement, the
average hospital should require no more than four person days per year
to report every death that occurs in the hospital to the OPO. This time
is in lieu of time hospitals' spend complying with existing
requirements. If tissue and eye referrals are made by the hospital to
either the OPO or a third party entity, rather than to tissue and eye
banks, calls made to tissue and eye banks about medically unsuitable
donors should not increase, as the calls will be screened by the OPO or
third party entity. However, we expect that OPOs will find that the
increased number of donations resulting from routine referral will
enable them to meet the additional expenses without a significant
increase to their current standard organ acquisition costs. Further
information about the expected economic impact of routine referral on
OPOs can be found in the Regulatory Impact Analysis.
Best Practices
Comment: Some commenters suggested that HCFA is abdicating its
policy-making and regulatory authority to the OPOs. The commenters
urged us to identify the best practices by which organ donation can be
increased and use those practices as the basis for a regulatory
definition of potential donor. The commenters pointed out that the
proposed rule indicates that approximately 12,000 to 15,000 of the one
million patients who die in hospitals annually are likely to be
potential organ donors but that the proposed rule does not establish
criteria by which hospitals would be required to identify those
patients.
Response: We have not specifically defined potential donor in the
final rule because the definition is continually changing, particularly
as to the upper age. Instead, we have included the requirement that
hospitals routinely refer all deaths and all individuals for
[[Page 33860]]
whom death is imminent to the OPO, with the assumption that this
requirement will, in most communities, lead to better identification of
the medical suitability of the potential donor based on the most recent
medical research in transplantation. Contrary to the commenter's
statement that one million patients die annually in hospitals, it is
estimated that there are approximately 2,080,000 hospital deaths per
year. The final rule also requires that the hospital and OPO
collaborate in advising the family of potential donors of their option
to donate. We have chosen not to dictate best practices for other
aspects of organ donation, such as education and death records review,
as we believe that each hospital and OPO, working together, can
identify practices that will be most useful in their specific
situation.
Following is a synopsis of the most recent research in organ
donation and best practices for organ donation. We encourage hospitals
and OPOs to use these studies and the many other studies that have been
done on best practices for organ donation to guide their development of
protocols that will work to increase organ donation in their
communities. The estimate of 12,000 to 15,000 potential organ donors
annually is based on the results of retrospective reviews of 1,990
medical records in 69 acute care hospitals in 4 geographic regions in
the United States and a stratified random sample of 89 hospitals in 3
of the same areas (33 of the same hospitals) in 1993. The study found
that only one third of the potential organ donors became organ donors.
By extrapolating the 1990 findings to the entire United States,
researchers postulated a pool of 13,700 medically suitable donors per
year. [Gortmaker SL, Beasley CL, et al. ``Organ donor potential and
performance: Size and nature of the organ donor shortfall,'' Critical
Care Medicine (1996); 24:432-39]
The study also showed that potential donors were correctly
identified 90 percent of the time, and families were advised of their
donation options only 71 percent of the time. The study's authors
concluded that prospective identification and requesting donation in
all suitable potential donor cases could lead to 1,800 additional
donors per year.
An earlier study based on 1988 and 1989 data estimated the pool of
potential organ donors to be between 6900 and 10,700 annually. [Evans
RW, Orians CE, Ascher NL. ``The Potential Supply of Organ Donors: An
Assessment of the Efficiency of Organ Procurement Efforts in the United
States,'' Journal of the American Medical Association (1992); 267:239-
246.] The study was based on a review of multiple cause of death data
from death certificates. The researchers excluded non-traumatic causes
of death and, therefore, may have underestimated the potential donor
pool by as much as 50 percent. However, the study demonstrated that
there are many more potential than actual donors. The study's authors
concluded that it may be possible to increase the number of actual
donors by 80 percent.
These studies and several other recent studies are defining the
best practices for increasing organ donation. As research continues in
the field of organ donation, best practices will continue to evolve.
Therefore, we are hesitant to use current best practices as the sole
basis for promulgating a regulation that cannot be changed quickly
enough to keep pace with the results of future research in the field of
organ donation. However, we firmly believe there has been sufficient
research upon which OPOs and hospitals can develop protocols that will
lead to a significant increase in organ donation rates.
Through this final rule and related activities in the National
Organ and Tissue Donation Initiative, we are encouraging hospitals and
OPOs to incorporate other best practices into protocols for increasing
donation rates. For example, recent studies have indicated that organ
donation rates can be increased using a variety of best practices
related to (1) advising families of potential donors of their rights
regarding donation; (2) medical record reviews for evaluating
performance and identifying opportunities for education; and (3)
education of hospital staff.
The study cited above [Gortmaker SL, Beasley CL, et al. ``Organ
donor potential and performance: Size and nature of the organ donor
shortfall,'' Critical Care Medicine (1996); 24:432-39] found that
approximately half of the families asked to donate a relative's organs
decline to give consent. Likewise, a stratified random sample of 23
acute-care general hospitals in two metropolitan areas found that only
46.5 percent of families of potential organ donors agreed to donate
organs, and 22 percent of those who agreed to donate placed conditions
on the donation. [Siminoff LA, Arnold RM, Caplan, AL, Virnig BA,
Seltzer DL. ``Public Policy Governing Organ and Tissue Procurement in
the United States.'' Annals of Internal Medicine. 1995; 123:10-17] The
study's authors concluded that ``problems with the ways in which
families are asked about donation rather than the failure of . . .
altruism, may account for the high refusal rate.''
An interview study of donor and nondonor families [DeJong W, Franz
HG. ``Requesting Organ Donation: An Interview Study of Donor and
Nondonor Families,'' American Journal of Critical Care (1998);7: 13-23]
identified the factors identified with consent for organ donation. The
study cites unpublished data [Gortmaker SL, Beasley CL, Sheehy E, et
al] that demonstrate a significant increase in the consent rate when
three elements are in place when the family is advised of its right to
consent to or to decline donation. First, family members must be given
time to understand and accept their relative's death before the
donation request is made. This means that the hospital staff's
notification of the family about the patient's death and the
explanation of brain death must be ``decoupled'' from the request for
donation. An earlier study of the consent process also found the timing
of the request to be critical. The study indicated a 60 percent consent
rate when the subject of organ donation was discussed with the family
before notification of death, a 68 percent consent rate when organ
donation was discussed simultaneously with notification of death, and a
78 percent consent rate when organ donation was discussed after
notification of death. [Cutler JA, et al. ``Increasing the Availability
of Cadaveric Organs for Transplantation: Maximizing the Consent Rate,''
Transplantation (1993); 56(1)225-28]
Second, consent rates are higher when the request is made by the
OPO in conjunction with the hospital staff. A retrospective review of
all medically suitable potential donors referred to a single OPO in a
one-year period found a 67 percent consent rate when the OPO
coordinator approached the family alone, a 9 percent consent rate when
the hospital staff approached the family alone, and a 75 percent
consent rate when the approach was made by the OPO coordinator and
hospital staff together. [Klieger J, Nelson K, Davis R, er al. Analysis
of Factors Influencing Organ Donation Consent Rates. Journal of
Transplant Coordination (1994); 4:132-34] A 1995 article [Dejong, W,
Drachman, et al. ``Options for Increasing Organ Donation: The Potential
Role of Financial Incentives, Standardized Hospital Procedures, and
Public Education to Promote Family Discussion,'' The Milbank Quarterly
(1995);73: 463-79] suggested that the donation option should first be
mentioned to the family by a hospital-based health professional, but
the
[[Page 33861]]
formal request should be made by the OPO coordinator.
The third critical element in the consent process is the setting in
which the request for donation is made to the family. The request
should be made in a quiet, private setting, such as a conference room
or family meeting room, rather than in a hallway or waiting room. When
all of these methods are used in conjunction, consent rates are 47
percent higher than when none of these methods is used.
The study's authors note that in general there is currently no
widely accepted protocol with regard to the process for requesting
donation. They suggest that hospitals' protocols should include (1)
communicating often and honestly with the family about the patient's
prognosis, (2) making sure the family understands brain death, (3)
decoupling the request for donation from the explanation of brain
death, (4) using a quiet, private setting for discussion of donation
options, and (5) defining clear roles and responsibilities for the
hospital staff and the OPO coordinator.
Another recent study [McNamara P, Franz HG, Fowler RA, et al.
``Medical Record Review as a Measure of the Effectiveness of Organ
Procurement Practices in the Hospital,'' Joint Commission Journal on
Quality Improvement (1997);23:321-33] makes several recommendations for
quality improvement initiatives based on medical records review. The
study's authors suggest that OPO staff provide feedback from medical
records review to key hospital staff concerning practice improvements.
They suggest hospitals use information from medical records review to
assess the hospitals' performance in the organ donation process,
identify areas where performance can be improved, and monitor the
effectiveness of the implemented changes. They also suggest that
medical records review should be conducted annually at large hospitals.
As referenced earlier, research in education of hospital critical
care staff [Evanisko MJ, Beasley, CL, Brigham, LE. ``Readiness of
Critical Care Physicians and Nurses to Handle Requests for Organ
Donation,'' American Journal of Critical Care (1998); 7:4-12] found
that training of critical care physicians and nurses in effective
procedures for requesting organ donation is significantly associated
with higher rates of organ donation. However, two thirds of critical
care staff reported no relevant training. A 1986 United Network for
Organ Sharing survey found a surprising lack of knowledge among the
transplant hospital staff regarding knowledge of organ donation and
transplantation. [Ettner BJ, Youngstein KP, Ames JE. ``Professional
Attitudes and Knowledge About Organ Donation and Organ
Transplantation,'' Dialysis and Transplantation, (1988); 17:72-76]
Eighteen percent of the respondents were physicians, and 68 percent
were nurses. Thirty-four percent of the respondents were unsure if
their hospital had written protocols for organ recovery, and nearly
half of the respondents answered no to the statement that the organ
donor protocols provided adequate guidelines and protection for the
donor and for hospital staff. The final rule ensures that only OPO
representatives or trained individuals will approach families to
explain their donation options and make the actual request for
donation.
Our review of these and other studies has convinced us that there
has been sufficient research upon which OPOs and hospitals can base
protocols that will take advantage of best practices for advising
families of their right to consent to or to decline donation, evaluate
hospital and OPO staff performance through medical records reviews, and
educate hospital staff.
Necessity for Change
Comment: Several commenters suggested that we make no change in the
hospital conditions of participation for organ procurement
responsibilities. They pointed out that the current regulations, which
allow hospitals to establish their own organ donation policies, often
result in good donation rates. They suggested that in lieu of a
regulation, HCFA continue to evaluate what works to increase donation
rates and encourage hospitals and others to make changes.
Response: The current hospital conditions of participation have not
produced the results which were anticipated. Therefore, in our response
to the previous comment, we outlined research studies that show several
approaches that work to increase donation rates. We believe that all
hospitals, including those that are currently successful, should
consider whether these approaches, in addition to routine referral,
could further increase organ donation. A study of 1,990 death records
from 69 hospitals in four geographic regions found a wide variation in
hospital performance with a hospital donation rate (i.e., actual donors
as a percentage of potential donors) ranging from 0 percent to 68
percent. Note that this was not a random sample of hospitals; the
hospitals tended to be larger institutions with either a history of
donor activity or suspected potential for donation. The average organ
donor potential in the hospitals was 13.3; average actual organ donors
were 4.3. [Sheehy E, Poretsky A, Gortmaker, SL. ``Relationship of
Hospital Characteristics to Organ Donation Performance,''
Transplantation Proceedings (1996); 28:139-141]
These data demonstrate that, some hospitals need more than
encouragement to meet the requirements of section 1138 of the Act,
which mandates that hospitals identify potential organ donors and
assure that families of organ donors are informed of their donation
options. In view of the critical and growing shortage of donated organs
in this country, we would be abdicating our responsibility as a Federal
agency if our only response to this crisis were merely to be
encouragement. We believe that a less burdensome approach for
hospitals, requiring only a phone call to the OPO, will be more
successful in providing opportunities for families to consider
donation. Therefore, we are not accepting this comment.
Comment: One commenter suggested a delay in publishing the final
rule until the Department can convene a workshop to come up with a
different proposal. The same commenter also suggested allowing
hospitals at least three years to develop an action plan to increase
donation rates.
Response: We believe the need to substantially increase organ
donation immediately outweighs any potential benefits from adopting the
commenter's suggestion. As noted above, 10 people die every day waiting
for an organ transplant. In addition, the Department sought public
comments on the issue of increasing organ donation as part of its
development of a related rule regarding the Organ Procurement and
Transplantation Network, including a three-day public hearing in
December 1996. It also conducted a conference in April 1998 to identify
methods to evaluate and identify successful mechanisms to increase
donating consent. In view of the every-widening gap between the number
of people waiting for organ transplants and the number of organs
available, further delay in passing a regulation to alleviate this
crisis is unacceptable.
Regulatory Flexibility
Comment: Many commenters warned against promulgating a final
regulation that is too prescriptive. They emphasized that what is
needed, above all, is flexibility to design protocols to meet needs of
local communities, rather than a ``one-size-fits-all'' regulation
[[Page 33862]]
which defines potential donor and the protocols for notification and
referral for the entire country. One commenter pointed out that such
flexibility allows for look-back data and new research to be
incorporated into hospitals' policies.
Response: We agree with these commenters and have used this
viewpoint to guide our development of the final rule. For example, it
allows the OPO to determine medical suitability in light of the most
recent transplantation research and the needs of transplant recipients,
surgeons, and hospitals. The final rule requires collaboration between
the hospital and the OPO in informing families of potential donors of
their donation options because the evidence is overwhelming that
involvement of the OPO in the consent process is critical. We believe
however, it is best for hospitals and OPOs to have the flexibility to
design a protocol for informing families that takes into account
circumstances in each community. Finally, the final rule allows
hospitals, OPOs, and tissue and eye banks the flexibility to adapt best
practices in the areas of death record reviews and education of
hospital staff to suit the circumstances in their local communities.
Medical Suitability
Comment: One commenter suggested there should be Federal baseline
criteria for defining potential donors, with HCFA setting minimum
standards, including tests, required for an individual to donate an
organ. Hospitals and OPOs could be more exacting, but could not fall
below the Federal standard. Another commenter called for a national
conference to determine the broadest possible definition based on
national need and the varying acceptance criteria of transplant
surgeons and institutions. For example, commenters suggested variously
that ``potential donor'' should be defined as a patient who is brain
dead and heart beating or any patient on a ventilator.
Response: We believe these commenters are seeking a Federal
definition for medically suitable donors, rather than a Federal
definition for potential donors. Generally, a definition for potential
donors is designed to cast a wide net by defining potential donors, for
example, as all hospital deaths or all patients on ventilators. By
making the pool of potential donors so large, OPOs ensure that no
medically suitable donors are missed. However, many, if not most, of
the potential donors in this large pool will not be medically suitable
to be actual donors.
We are reluctant to impose a Federal standard for medically
suitable donors. Some OPOs, for example, the Louisiana Organ
Procurement Agency, have experimented with expanded criteria for
determining medically suitable donors, with good results. However,
transplant hospitals vary in their willingness and ability to
transplant organs from potential donors with particular medical
conditions or from donors who are past a certain age. At one time, most
organ donors were age 45 or younger; now some transplant hospitals are
transplanting livers from 80-year-old donors. According to the Organ
Procurement and Transplantation Network contractor, the 33 percent
increase in cadaveric donors between 1988 and 1996 is primarily due to
the increase in donors ages 50 and over. Cadaveric donors age 50 and
over increased from 12 percent in 1988 of all cadaveric donors to 27
percent in 1996. [United Network for Organ Sharing 1997 Scientific
Registry and Organ Procurement and Transplantation Network Annual
Report] Some transplant hospitals will consider organs from donors with
any medical condition other than metastatic cancer or HIV; other
transplant hospitals are more restrictive.
It is likely that as transplantation research continues, the
ability of medical professionals to obtain and transplant organs from
patients once considered medically unsuitable will grow. Therefore,
since the definition of medically suitable donor will likely be
broadened in the future, we believe it would be inappropriate to impose
a regulatory definition.
Comment: One commenter stated that in order to determine if a
potential donor is medically suitable to be a donor, it may be
necessary for the OPO to examine the body, conduct tests, review
medical records, and obtain medical information from the family and
physician. The commenter said that hospitals have expressed concern
that this violates laws governing patient privacy and confidentiality
of medical records and asked us to emphasize that the authority to do
so is implicit in the law.
Response: We agree with the commenter that the OPO may examine the
body of the potential donor and his or her medical records and conduct
the tests, inquiries, and investigations that are necessary to
determine if the potential donor would be medically suitable to be a
donor. The Public Health Service Act section 371, 42 U.S.C. 274
specifies that OPOs must arrange for the acquisition and preservation
of donated organs and provide quality standards for the acquisition of
organs which are consistent with the standards adopted by the OPTN
under section 372(b)(2)(E), including arranging for testing with
respect to preventing the acquisition of organs that are infected with
the etiologic agent for acquired immune deficiency syndrome. Section
371 of the Act also specifies that OPOs must arrange for the
appropriate tissue typing of donated organs. Certainly, after receipt
of consent for donation from the potential donor's family, it would be
necessary for the OPO to examine the body of the potential donor,
conduct tests, review medical records, and obtain medical information
from the family and physician in order to accomplish the requirements
of section 371 of the Act. Therefore, after receipt of consent, we
believe the authority to conduct testing, review medical records, and
gather other medical information needed to determine the medical
suitability of the potential donor is implicit in the law.
OPO Conditions of Coverage
Comment: Some commenters had suggestions for changes in the OPO
procedural standards in the regulations governing OPOs, such as
requiring OPOs to refer potential tissue donors to eye banks and/or
tissue banks.
Response: We are not making changes to the OPO conditions of
coverage here, as the OPO conditions of coverage are not within the
purview of this regulation. However, we will retain the comments for
reference and continue to review the OPO requirements with a view
toward improving their effectiveness. In addition, we would point out
that the OPO conditions of coverage do require OPOs to ``have
arrangements to cooperate with tissue banks for the retrieval,
processing, preservation, storage, and distribution of tissues as may
be appropriate to assure that all usable tissues are obtained from
potential donors.'' [42 CFR 486.306(l)] Because this final rule does
establish OPOs as the default gatekeepers for referral of tissues and
eyes, we will regard very seriously the failure of any OPO to refer
promptly all potential tissue and eye donors to the tissue and eye
bank(s) specified by the hospital.
Comment: One commenter cited ``anecdotal evidence'' that managed
care organizations, hospitals, and other providers are reluctant to
provide services for patients with non-survivable brain injuries. The
commenter recommended changing HCFA reimbursement rules for OPOs to
allow costs related to donor clinical assessment prior to declaration
of death. The commenter suggested this would eliminate a barrier to
OPOs' early
[[Page 33863]]
involvement with the potential donor and address hospital concerns
regarding donation-related charges incurred prior to brain death.
Response: Although reimbursement is not within the scope of this
regulation, HCFA will be looking into this matter with a view to
determining what steps appropriately can be taken to ensure that
providers' difficulties in obtaining reimbursement for services to
patients with non-survivable brain injuries does not become a barrier
to organ donation.
Comment: A few commenters responded to our request for suggestions
about how to design or implement the most cost-effective outcome
standard for OPOs related to organ recovery. The commenters called for
a more precise way to measure potential donors for comparison with
actual donors so that each OPO is evaluated in light of its true
potential. Some commenters said that if HCFA adopts an outcome standard
based on conversion of potential to actual donors, the current
performance standards should be reviewed with a view to changing or
eliminating them.
Response: We agree that the current method of using population to
define potential donors may not reflect regional differences in number
and cause of deaths. A recent GAO report [U.S. General Accounting
Office, ``Alternatives Being Developed to More Accurately Assess
Performance (GAO/HEHs-98-26),'' (November 1997)] noted that unless OPO
performance is measured according to the number of potential donors,
HCFA cannot determine OPOs' effectiveness in acquiring organs. We agree
with the conclusions of the GAO report and will be evaluating two
methods suggested by the GAO for more accurately identifying the number
of potential donors in an OPO's service area: death record review and
modeling. We also will be evaluating the results of the study of death
record reviews being conducted by the Association of Organ Procurement
Organizations in conjunction with the American Congress for Organ
Recovery and Donation (ACORD) and a methodology for estimating
potential donors, which is being developed by Harvard Medical School,
the Harvard School of Public Health, and the Partnership for Organ
Donation. If the current method of using population to estimate the
number of potential donors in an OPO's service area is changed, we will
review all OPO conditions of coverage to determine their
appropriateness in view of that change.
Comment: One commenter suggested hospitals should be allowed to set
minimum credentials for OPO personnel working in their hospitals. The
commenter said surveys of donor family satisfaction and satisfaction of
hospital personnel with OPO personnel should be permitted, and
hospitals should have the option of terminating their contract with the
OPO if a workable solution is not found.
Response: There is nothing in the regulation that precludes a
hospital from surveying donor families or hospital personnel to
determine their level of satisfaction with the OPO. However, standards
for OPO personnel are a HCFA responsibility. [42 CFR 486.306] A
hospital dissatisfied with its designated OPO has the option of
requesting a waiver from HCFA permitting an agreement with an OPO other
than the OPO designated for the service area in which the hospital is
located. To qualify for a waiver, the hospital must submit data to HCFA
showing that the waiver is expected to increase organ donations and
will ensure equitable treatment of patients referred for transplants
within the service area served by the hospital's designated OPO and
within the service area served by the OPO with which the hospital seeks
to enter into an agreement.
Resolution of Disputes
Comment: Several commenters suggested there should be a mechanism
for ``due process'' if there are disagreements between OPOs and
hospitals or between OPOs and tissue and eye banks. One commenter
suggested that the rule should require an agreement as to the content
of the protocols signed by both the OPO and the hospital. The commenter
suggested that the Department should set up a system for mediating and,
if necessary, arbitrating disputes. In the case of arbitration, the
decision of the Secretary would be final.
Response: We have tried to structure a final rule that will
encourage hospitals and OPOs to work together to alleviate the critical
shortage of organs for transplant. We have included a requirement that
hospitals and OPOs work ``collaboratively'' in advising families of
potential donors of their donation options. We have included a
requirement that hospitals work ``cooperatively'' with OPOs and tissue
and eye banks in reviewing death records, educating hospital staff
about donation issues, and maintaining potential donors. We have
included a requirement that the OPO consult with a tissue and an eye
bank in developing protocols for identification and referral of tissues
and eyes. We believe these requirements will obviate the need for
dispute resolution mechanisms, such as mediation or arbitration.
However, based on the correspondence we have received, we understand
that, in some communities, relationships between hospitals and OPOs and
between OPOs and tissue and eye banks are contentious and that
collaboration may prove to be difficult.
We know that hospitals, OPOs, and tissue and eye banks share our
view that organs and tissues are a precious national resource and that
only through the collaborative efforts of all parties can lives be
saved. As one commenter wrote, ``at risk in * * * this issue are
patient lives that could either be saved or be unnecessarily lost by
the success--or failure--of hospitals and OPOs working together.''
We will monitor donation rates and OPO and hospital performance
after this rule becomes effective. In those instances where tensions
among the actors in the donation process are hindering improvements in
organ donation, we will explore ways in which we might play a
constructive role in encouraging and facilitating a successful local
solution.
Family Consent to Donation
Comment: One commenter expressed concern that strengthening the
role of the OPOs in the donation process will encourage OPOs to apply
too much pressure on bereaved families in order to meet HCFA
performance standards. The commenter suggested the final rule should
address the need for sensitivity toward families and their religious
views and the need for education of hospital staff in sensitivity to
families' grief. Another commenter cited OPO ``quotas'' and hospitals'
concerns about lack of control as reasons why the OPO should not be
involved with the potential donor's family until the family has agreed
to donation or requested additional information about donation.
Response: We have no evidence that families of potential donors are
being pressured by OPO or hospital staff and no reason to believe that
this change in the hospital conditions of participation would lead to
such a problem. We note however, that the final rule requires
collaboration between the hospital and OPO in informing families of
potential donors of their donation options and also requires hospitals
to encourage discretion and sensitivity with respect to the
circumstances, views and beliefs of families of potential donors. In
addition, the final rule both permits the hospital to choose the
individual who will initiate the request for donation to the family and
ensures that the
[[Page 33864]]
individual initiating the request has been educated in the consent
process.
Although our earlier references to research on the family consent
process emphasize that best practices lead to improved consent rates,
such improvement is achieved in large part through greater sensitivity
to families and their beliefs, their backgrounds, and their grief. For
example, the interview study cited earlier [DeJong W, Franz HG.
``Requesting Organ Donation: An Interview Study of Donor and Nondonor
Families,'' American Journal of Critical Care (1998);7:13-23] discusses
family demographic characteristics, such as race, ethnicity, and
education and concludes, ``This information should be used to remind
the health care team to be especially attentive to concerns that
certain families might have and to take special care to meet the
families' informational and emotional needs. Healthcare providers
should approach the family with the belief that a donation is possible
and should take steps to ensure the family is treated with respect and
care.''
The services provided by Nebraska Health Systems are an example of
what hospitals and OPOs can do to increase family consent to donation
while providing emotional support and counseling to grieving families.
This transplantation facility offers a program called Acute Bereavement
Services, staffed by organ recovery personnel, nurse resource
coordinators, and pastoral care staff. These individuals are available
at any time to guide discussions with survivors concerning potential
organ and tissue donation; act as a resource for family questions about
funeral arrangements, coroner notification, autopsy consent, grief
resources, hospital leave-taking, religious resources, and ritual; act
as a resource for staff questions about notification of organ recovery
staff; and act as advocates for the immediate grief needs of survivors.
Nebraska Health Systems instituted their Acute Bereavement Services
because ``we wanted to have a positive impact on the grieving process
even after our medical responsibilities to the patient and family
ended.'' In 1996, the Nebraska Health Systems family consent rate was
75 percent. Hospitals interested in obtaining more information about
Acute Bereavement Services can contact Nebraska Health Systems at Box
984075, 600 South 42nd St., Omaha, NE 68198-4075, Attention: Marsha
Morien.
Comment: Some commenters voiced concern about the use of the word
``discretion'' in the text of the regulation. The regulation requires
that hospitals ``encourage discretion and sensitivity with respect to
the circumstances, views, and beliefs of the families of potential
donors.'' Commenters suggested there is a risk that in some
circumstances the term ``discretion'' might be used as a justification
to avoid advising eligible families about organ donation because of a
presumption on the part of hospital staff that the family would not be
receptive because of their intense grief, socioeconomic status, race,
or religion. The commenter cited a study that found minority families,
particularly African Americans, were less likely to be asked about the
option of donation. The commenter suggested this might be due to
hospital staff perception that ethnic minorities are opposed to
donation, despite ample evidence that minorities donate in significant
numbers. One OPO commented that the greatest impediment to donation is
a hospital's conclusion that consent cannot be obtained. The OPO
stated, ``In such a situation, the OPO has lost a potential donor
without ever being afforded the opportunity to act.''
Response: Our use of the term ``discretion'' in the text of the
regulation reflects the statute's use of that term in section
1138(a)(1)(A)(ii) of the Act. However, we are grateful for an
opportunity to point out that our use of the term ``discretion'' in the
text of the regulation should not be construed to mean that hospital
staff should, under any circumstances, make a judgment that certain
families should not be approached about donation. The hospital staff's
perception that a family's grief, race, ethnicity, religion, or
socioeconomic background would prove a barrier to donation should never
be used as a reason not to approach the family. We cannot emphasize too
strongly that all families of potential donors must be advised about
their donation options.
Comment: Many commenters strongly supported our language regarding
notification of donor families. Many mentioned the research that shows
that highest family consent rates are obtained when OPOs and hospitals
collaborate. One OPO reported an 87 percent consent rate when OPO staff
and hospital staff collaborate in the request to the family and a 38
percent consent rate when the hospital staff approach the family alone.
Some commenters emphasized that hospital staff should be free to
continue to participate in advising families of their donation options.
However, one commenter suggested that if hospital staff consent rates
differ markedly from OPO staff consent rates, the hospital should be
required to return consent responsibility to the OPO or provide
training to hospital staff. Some commenters recommended that the
regulation specify that only trained personnel (whether OPO or hospital
staff) are permitted to advise families of potential donors of their
donation options. One commenter pointed out that in Pennsylvania, which
has a routine referral law, hospital personnel can become designated
requestors only after undergoing training by the OPO.
Response: We appreciate the commenters' support for the final
rule's emphasis on collaboration in notifying families of potential
donors of their options for donation. Research has shown best practices
include participation of both OPO personnel and hospital staff in the
process, with the actual request for donation made by OPO personnel. We
encourage hospitals and OPOs to consider these best practices when
determining how this process will occur. We agree with the commenters
who suggested that only personnel trained in the consent process be
permitted to approach families with a request for donation, and we have
included that provision in the final regulation. We have also modified
the text of the regulation to make it clear that hospitals have
discretion in determining who will initiate the request for donation.
Comment: Some commenters suggested further strengthening the rule
by giving the OPOs even more control over the process. For example, one
commenter suggested the rule be strengthened to give OPOs the sole
responsibility for initiation of the request for organs or tissues. The
commenter mentioned that currently OPOs are being held accountable by
the Federal government but have not been given the tools to increase
donation rates. Several commenters urged us to eliminate the
requirement for collaboration between the OPOs and the hospital in the
consent process and make it clear that only OPO staff should be
permitted to approach the family about donation.
Response: We are sympathetic to the commenters' point of view. OPOs
have been in the difficult position of having to meet specific
performance standards for organs donated and transplanted, while at the
same time having less than total control over the donation and
transplantation processes. However, we disagree that only OPOs should
be permitted to advise families of potential donors of their donation
options. As stated elsewhere in this preamble, studies show that the
highest family consent rates are a result of collaboration between OPOs
and
[[Page 33865]]
hospitals. The participation of hospital staff is critical both to
ensure that a family understands and accepts the brain death of the
potential donor and to provide compassionate support to the family. A
1987 study of donor family perspectives concluded that the hospital
nursing staff are in the best position to have a positive effect on
donor families' attitudes toward their donation experiences and,
ultimately, as families share their experiences with family and
friends, in the future availability of organs for transplant.
[Bartucci, MR. ``Organ Donation: A Study of the Donor Family
Perspective.'' Journal of Neuroscience Nursing. 1987; 19:305-309] The
final rule gives OPOs considerably more control over the donation
process while at the same time encouraging collaborative relationships
between OPOs and hospitals.
Death Record Reviews
Comment: Many commenters strongly supported the requirement for
death record reviews. One commenter, a hospital association from a
State with a routine referral law, suggested that death record reviews
be performed only by licensed OPOs. Another commenter encouraged us to
take the next step by providing support and resources to allow
compilation of medical records review data in a centralized database,
and by accelerating the development and application of methods to
accurately estimate underlying donor potential in hospitals and OPOs.
Response: We agree that death record reviews are an essential
component of this final rule. We expect that requiring hospitals to
cooperate with OPOs, tissue banks and eye banks in reviewing death
records will allow the OPOs, tissue banks and eye banks the opportunity
to review death records to determine donor potential, monitor hospital
compliance, and identify areas where education in a hospital's organ
donation procedures is needed. The final rule will permit the hospital,
OPO, tissue bank, and eye bank to determine who will perform the death
record reviews. Providing resources for compilation of medical records
review data is beyond the scope of this regulation. However, we are
interested in a further exploration of how such a database could be
useful in increasing organ donation. We are currently considering
various methods for estimating donor potential and are also awaiting
the outcome of a review of hospital death records being conducted by
the Association of Organ Procurement Organizations in conjunction with
the ACORD.
Comment: A few commenters were concerned that giving outside
agencies access to death records would be disruptive or would
jeopardize patient confidentiality.
Response: In requiring hospitals to work cooperatively with OPOs,
tissue, and eye banks in performing death record reviews, we are
confident that a system can be worked out among all parties to minimize
disruptions. Likewise, we would expect that all parties can come to an
agreement on the protocols that will be used both to perform death
record reviews and analyses. We also expect all parties involved to use
the resulting data in a manner that ensures patient confidentiality is
not threatened. Note that both hospital and OPO regulations require
hospitals and OPOs to have procedures for ensuring the confidentiality
of patient records. Hospitals and OPOs must ensure that unauthorized
individuals cannot gain access to or alter patient records. Hospitals
and OPOs must also ensure that original medical records are released
only in accordance with Federal or State laws, court orders, or
subpoenas. [See 42 CFR 482.24(b)(3) and 42 CFR 486.306(o).] We believe
that sufficient safeguards exist in Federal and State law to protect
the confidentiality of hospital death records.
Comment: One commenter asked that HCFA provide explicit authority
for OPOs to conduct audits of hospital organ and tissue donation
performance to be provided upon request to HCFA or the Joint Commission
on Accreditation of Health Care Organizations. Confidentiality would be
assured as a condition of OPO designation.
Response: Although this regulation does not give OPOs specific
authority to conduct death record reviews, it does require that
hospitals work cooperatively with their OPOs in reviewing death
records. This means that a hospital must develop a protocol which
permits the OPO access to death record information that will allow the
OPO to assess the hospital's donor potential, assure that all deaths or
imminent deaths are being referred to the OPO in a timely manner, and
identify areas where both OPO and hospital staff performance might be
improved.
General Comments
Comment: One commenter cited ``concerns in the medical community''
about the broad language of the proposed rule and the possibility that
unintended and unanticipated actions could be taken. The commenter
suggested that we hold meetings with interested parties to assess their
understanding of the language and request suggestions for clarifying
the proposed rule.
Response: We carefully considered all comments we received from
hospital and medical associations; tissue and eye banks and their
professional organizations; transplant and donor organizations; OPOs;
and other organizations and individuals. In addition, we have tried to
be quite specific in this preamble in our discussions of the meaning of
the regulation text and in our suggestions for implementation.
Comment: Some hospital associations expressed concern that OPOs
would establish policies that are unworkable because the proposed rule
provides no guidance to OPOs about the policies they should establish.
The hospital associations gave as an example, the proposed requirement
that the hospital assure that the family of each potential donor knows
of its option to donate or decline to donate organs or tissues. They
suggested that if an OPO defined potential organ donor as any patient
who dies, the hospital would be required to inform the families of all
deceased patients of their donation options even if it knew the
patients were not medically suitable to be donors.
Response: We believe the final rule's emphasis on cooperation and
collaboration between hospitals and OPOs will ensure protocols are
developed and implemented that will function efficiently for both
hospitals and OPOs. In addition, since OPOs must meet regulatory
performance standards, it certainly is in their best interests to
establish policies that are workable.
Comment: One commenter stated that the key to success of protocols
for defining and referring donors will be ensuring that the burden on
hospitals to carry out the protocols is not unduly heavy. The commenter
suggested there should be some latitude in local protocols but that all
protocols should strive to meet three criteria: (1) Ensuring that no
medically suitable potential organ donor is missed; (2) minimizing the
number of non-eligible cases that are referred; and (3) ensuring
referral well before discontinuation of ventilation and cardiac arrest.
Others echoed the third criterion in asking us to clarify that,
whenever possible, referrals should be made when death is imminent to
ensure that brain-dead or near brain-dead patients are maintained until
a referral is made and are not referred to the OPO after mechanical
support has been discontinued.
[[Page 33866]]
Response: We agree with the commenters' first and third criteria
and believe the final rule will achieve these goals. OPOs are the
entities familiar with the parameters for transplantable organs used by
transplant hospitals and surgeons. Routine referral coupled with the
OPO's determination of medical suitability increases the likelihood
that no medically suitable potential donors are missed.
The requirement for timely referral at death or when death is
imminent means that hospitals must make referrals both before a
potential donor is removed from ventilator and while the potential
donor's organs are still viable. Timely referral also means that the
hospital must notify the OPO about potential donors early enough in the
process to allow sufficient time for the family of the potential donor
to make an informed decision about donation. We added these
requirements to the final rule to minimize the possibility that organs
will be lost to medical complications. One recent study noted that
without aggressive support, cardiac arrest occurs in 20 percent of
potential donors within 6 hours after the declaration of brain death
and in 50 percent of donors within 24 hours. The authors conclude that
delays in referrals may reduce the availability of organs since
hemodynamic instability and cardiac arrest can develop relatively soon
after brain death and emphasize that early identification and
intervention are crucial for the successful recovery of organs.
[Hauptman PJ, O'Connor KJ. ``Medical Progress: Procurement and
Allocation of Solid Organs for Transplantation,'' New England Journal
of Medicine; 336:422-431]
With respect to the commenters' second suggested criterion, we
would prefer also to minimize the referrals of potential donors later
determined not to be medically suitable. We believe such an approach is
implicit in our current regulation which permits hospitals to develop
protocols for potential donors and refer only those cases to OPOs.
However, as discussed previously, this approach has resulted in a
significant percentage of potential donors not being identified.
Comment: Some commenters suggested we include provisions and
funding for public education, which could be a cooperative effort by
the OPOs and hospitals. One commenter questioned the need for any of
the provisions in the proposed rule and implied the best way to
increase the donation rate is to educate the public.
Response: We agree with the commenters that public education about
organ donation is important and a variety of efforts have been and will
be needed to enhance public awareness of the benefits of organ
donation. The Department of Health and Human Services launched the
National Organ and Tissue Donation Initiative with dozens of partners
in December 1997. One of the three goals of the initiative is to build
public awareness about the essential role of families in consenting to
donation. The initiative features the Coalition on Donation's message,
``Organ and Tissue Donation: Share your life. Share your decision'' to
underscore the need for family discussion about donation. The
Department also has a new site on the Internet at http://
www.organdonor.gov to provide up-to-date information to the public
about organ and tissue donation and transplantation.
However, we do not believe we should rely exclusively on that as a
strategy to increase donation. If hospitals do not identify potential
donors, if families of potential donors are not asked to donate, or if
those families are asked in a way that is unlikely to lead to their
consent for donation, then public support for organ donation is
immaterial.
Comment: Several commenters suggested we expand the definition of
organ to include small bowel or intestine.
Response: We will not expand the definition of organ at this time.
Before moving forward, we will need to assess fully the policy
considerations of expanding the definition of organ to include small
bowel or intestine. However, we will retain these comments with a view
toward consideration of expanding the definition of organ in a future
regulation.
Comment: A rural hospital suggested we take into account rural
frontier areas when finalizing the regulation. They pointed out that
their closest tertiary facility is 300 miles away. Another commenter
recommended an exemption from the regulation for hospitals without
potential donors, such as those facilities that lack ventilator support
capabilities, do not have ICUs and do not provide trauma, neurology or
neurosurgery services.
Response: We do not intend to establish exemptions for particular
types of hospitals at this time. We do not believe routine referral
will be burdensome to these small hospitals, and we believe that the
information provided to the OPOs through the referral calls made by
these hospitals may prove to be useful for organ, tissue, or eye
donation.
Comment: A commenter pointed out that studies have shown that
transplant hospitals as a group are no more effective in organ donation
than non-transplant hospitals. The commenter recommended an extra level
of donation accountability for transplant hospitals.
Response: We believe the requirements contained in the final rule
will maximize the number of transplantable organs yielded by every
hospital, making it unnecessary to have a different level of
accountability for transplant hospitals. We agree that transplant
hospitals should be especially active in identifying potential donors.
However, we intend to hold all hospitals to the same level of
accountability, that is, to use their best efforts to respond to the
critical organ shortage.
Comment: Three commenters described proposed regulations or
existing laws in their States that require hospitals to develop their
own protocols for organ donation. The commenters expressed concern that
the proposed rule is in conflict with those State laws because it would
remove a hospital's authority under State law to determine a potential
donor's medical suitability.
Response: We do not believe the final rule is in conflict with the
spirit of the State legislation described by the commenters, which
appears to have been written for the purpose of increasing organ
donation. We note that in the 1980s, 44 States and the District of
Columbia passed legislation designed to increase organ donation by
requiring hospitals to develop protocols for identifying potential
organ donors and informing families of their option to donate, and it
is clear from the research on potential donors that have not been
identified by hospitals that the laws have been inadequate. In
response, States have begun to pass routine referral laws. We would
also point out that the Federal regulation would supersede both State
law and State regulations to the extent that it presents otherwise
irreconcilable conflicts with State policies.
Comment: One commenter had several questions related to how various
issues should be handled in cases where two or more OPOs are operating
in the same area, such as whether hospitals would be responsible for
two or more sets of criteria from these OPOs.
Response: The regulations at 42 CFR Part 486, Conditions for
Coverage for Organ Procurement Organizations, specifically
Sec. 486.316, states that HCFA designates only one OPO per service
area. A hospital must enter into an agreement only with the OPO
designated to serve the area in which
[[Page 33867]]
the hospital is located unless HCFA has granted the hospital a waiver.
Thus, a hospital would never be permitted nor required to have an
agreement with more than one OPO at a time.
Hospitals' Provision of Transplant Data and Hospital Accountability
Comment: Several commenters urged us not to add outcome standards
to the regulation because they would be too prescriptive. One commenter
suggested individual hospitals should decide whether they need to
monitor their outcomes.
Response: This regulation does not include numerical organ donation
goals for hospitals.
Comment: An OPO pointed out that a hospital cannot (except with HHS
approval) choose its OPO and is at the mercy of how well the OPO
performs. The commenter suggested that to ensure hospitals' cooperation
and to ensure they are not evaluated on the basis of their OPOs'
performance, a provision be added to the final rule that states a
hospital has met its obligations under section 1138 of the Act if it
has entered into an agreement with an OPO designated by HCFA, the OPO
certifies that the hospital has complied with the agreement and
protocols, and the hospital has authorized the OPO to determine medical
suitability and to make requests for donation.
Response: We see no need to include this specific language in the
regulation. However, we would agree that if a hospital has met the
requirements in the regulation, then it is likely the hospital has met
its obligations under section 1138 of the Act, regardless of whether
the OPO's performance has been satisfactory or unsatisfactory. Meeting
the requirements of the regulation include, but are not limited to,
referring all deaths to the OPO and ensuring that the family of every
potential donor determined by the OPO to be medically suitable for
donation has been advised of its donation options by an OPO
representative or a designated requestor.
Comment: One commenter suggested oversight of the hospitals' actual
participation in the process, which could be assured through death
record reviews, audit results, or other record keeping to demonstrate
the hospitals' level of compliance. The commenter added that this
should be enforced by Medicare surveyors, and a second commenter urged
us to discuss our plans for educating surveyors to ensure that
hospitals will work assiduously to meet organ donor identification,
referral and other related requirements. Another commenter suggested
that hospitals be required to maintain records of a quality improvement
process that supports its protocols. One commenter stated that they
would support the inclusion of an assessment of organ donation
procedures as part of a hospital's overall quality assessment and
performance improvement process. The commenter added that such a
provision would establish a hospital's accountability for actions it
can control. Some commenters recommended including performance
standards for hospitals to measure the variance between the number of
potential donors, referrals, and actual donations. The commenters added
that OPOs should participate in developing performance indicators based
on documented best practices.
Response: Surveyors and HCFA regional offices will oversee
compliance with the requirements of this regulation. However, surveyor
procedures are beyond the scope of this regulation. The proposed rule
for the hospital conditions of participation does not propose a
specific set of quality indicators or objective performance measures be
used. Instead, each hospital would be allowed flexibility to identify
its own measures of performance for the activities it identifies as
priorities in its quality assessment and performance improvement
strategy. We recommend that every hospital make organ donation one of
its priorities for quality assessment and performance improvement.
Death record reviews are a powerful tool hospitals can use in their
quality assessment and performance improvement strategies. In addition,
we strongly recommend that OPOs perform death record reviews and advise
hospitals of any failure to identify or refer potential donors or to
advise families of potential donors of their donation options.
Comment: Many commenters suggested that the proposed rule must be
strengthened to hold hospitals accountable if they do not cooperate
with OPOs. Several commenters stated that the language of the proposed
rule falls short of requiring hospital staff to cooperate with the OPO.
One commenter suggested that we strengthen the language related to
termination of participation in Medicare and Medicaid if a hospital
does not cooperate. Another commenter added, ``We do not see how these
proposed regulations will make a hospital with a ``lukewarm'' interest
in donation become more actively involved in the process.''
Response: We believe the language of the final rule is unequivocal
in requiring a hospital to refer all deaths to the OPO or a third party
designated by the OPO, collaborate with the OPO in assuring that
families of potential donors are advised of their donation options, and
cooperate with the OPO and tissue and eye banks in reviewing death
records and educating hospital staff in donation issues. This
regulation is part of the conditions for hospital participation in the
Medicare and Medicaid programs. Therefore, a hospital will jeopardize
its Medicare and Medicaid certification should it fail to meet the
requirements listed in the regulation.
Hospital Transplant Data
Comment: We received many comments about the requirement in the
proposed rule for transplant hospitals to provide transplant-related
data. Several commenters pointed out that the text of the proposed rule
specifies that the data must be provided to the Organ Procurement and
Transplantation Network, the Scientific Registry, the OPOs, and the
Department of Health and Human Services, whereas the preamble language
specifies that the data must be provided to the Organ Procurement and
Transplantation Network, the Scientific Registry, the OPOs, or the
Department of Health and Human Services. Commenters added that
requiring hospitals to report data to all entities would be
duplicative, burdensome, and would increase administrative costs.
Response: The information provided in the preamble was correct. The
text of the final rule has been changed to state that the data must be
provided as requested to the OPTN, the Scientific Registry, or the
OPOs. The hospital must also provide data directly to the Department
when requested by the Secretary. However, our intent is not to require
hospitals routinely to report identical data to more than one entity,
but rather to authorize direct requests by each of these entities.
Comment: Several commenters asked whether the intent of this
provision is to require hospitals to provide tissue transplant data as
well as organ transplant data. They pointed out that approximately
500,000 tissue transplants are performed annually in the U.S., and
providing tissue transplant data would be a significant burden for
hospitals.
Response: This requirement applies only to organ transplant data.
The text of the regulation has been changed to clarify that hospitals
must provide organ-transplant-related data.
Comment: Many commenters pointed out that the proposed rule was too
vague regarding the type of data hospitals would be required to provide
and how often they would be required to provide it. Commenters asked
for reassurance that data requests will be reasonable.
[[Page 33868]]
One commenter suggested that we specify what data will be requested and
allow time for meaningful comment. The commenter added, ``In the
absence of this specificity, the claim on page 66754 of the Federal
Register that these requirements are usual and customary in the conduct
of hospital business are without foundation.'' Another commenter asked
that we specify the branch of the Department that will receive the
data.
Response: At this time, we have not determined the type of organ
transplant data that may be requested by the Department. We included
this provision to give the Department the flexibility to request data
from transplant hospitals in the event that needed data cannot be
obtained expeditiously from the OPOs, the OPTN, or the Scientific
Registry. Data may be needed by HCFA, the Health Resources and Services
Administration (HRSA), or the Office of the Secretary, but, under this
regulation, data could be requested by any agency within the
Department. Note that a similar provision regarding the mandatory
reporting of data by transplant hospitals also is contained in a
related regulation. [See final rule with comment period, Organ
Procurement and Transplantation Network [98-HRSA-01, 63 FR 16295]
published April 2, 1998, effective October 1, 1998.] In accordance with
42 CFR 121.11(a)(2)(record maintenance requirements for OPOs and
transplant programs) and 121.11(b)(2) (reporting requirements for OPOs
and transplant hospitals) these programs are required to maintain and
report to the OPTN, the Scientific Registry, and the Secretary data
concerning, among other things, each potential donor identified.
Therefore, the requirement in this (HCFA) rule, when considered with
the requirements in the OPTN rule, will enable the Department to obtain
information routinely from all transplant hospitals and OPOs in support
of donation programs under this authority.
Comment: Several commenters expressed concern about the
confidentiality of the data and pointed out the extremely sensitive
nature of transplant patient data. One commenter stressed that because
the patient population is relatively small, it is difficult to protect
patient confidentiality, even when patient identifiers are removed from
the data.
Response: HCFA's primary intent is to use requested data internally
to assess whether a transplant hospital is qualified to participate (or
continue to participate) in the Medicare program and monitor organ
donation. We agree that the confidentiality of donor and transplant
recipient records must be protected and are confident that Federal and
State laws provide adequate safeguards. No additional specific
provisions to protect confidentiality are required in this regulation.
Comment: One commenter suggested that the public have access to all
data provided by the transplant hospitals. However, several commenters
warned that release of data without proper analysis and verification
can result in dissemination of inaccurate or misleading information.
One commenter noted that release of such data may harm individuals or
have a negative impact on organ donation.
Response: Section 121.11(b)(1)(v) of the recent OPTN regulation
[98-HRSA-01, 63 FR 16295] requires the OPTN and the Scientific Registry
to provide data which is to be used for bona fide research or analysis
purposes, to the extent that resources permit, or as directed by the
Secretary. Section 121.11(b)(1)(vi) requires the OPTN and the
Scientific Registry to provide data to the public. Section 121.11(b)(2)
requires that hospitals and OPOs provide data directly to the
Department upon request and that they may not impose restrictions on
subsequent redisclosure. The Secretary has requested comments on
whether the provisions ``sufficiently achieve the several important
purposes served by providing information to the OPTN, the Department,
and the public, while protecting patient privacy.''
Another related provision Sec. 121.11, ``Public access to data''
provides that the Secretary may release to the public information that
will serve the public interest. This information would include data on
comparative costs and outcomes at different transplant programs,
information on waiting list time, and information on the frequency with
which transplant hospitals refuse offers of organs for their listed
patients. The preamble to the OPTN regulation notes that release of
this data is consistent with section 375 of the Public Health Service
Act, 42 U.S.C. 274c, which directs the Department to provide
information to patients, their families, and their physicians about
transplantation resources and about the comparative costs and patient
outcomes at each transplant hospital affiliated with the OPTN.
IV. Provisions of the Final Rule
We are adding Sec. 482.45 in regulations to add the new
requirements concerning organ procurement organizations and transplant
hospitals. The final rule strengthens the role of OPOs in the donation
process, encourages the use of best practices, and provides a framework
for better collaboration among organizations involved in organ, tissue,
and eye donation with the goal of making transplants more readily
available to the many patients who need them. We are confident these
revisions to the current hospital conditions of participation will
narrow the gap between the number of deaths of patients on the waiting
list and the number of organs available for transplant.
The final rule will enable hospitals and OPOs to take advantage of
the most recent research in organ donation by using protocols that have
proved successful for referring potential donors, obtaining family
consent for donation, educating OPO and hospital staff, and reviewing
death records. We have written the provisions of this final rule to
enable hospitals and OPOs to take advantage of these best practices in
order to increase organ donation rates nationwide.
In view of the research that has been done in the field of organ
donation, the demonstrated increase in organ donation rates in States
that have passed routine referral laws, and the comments we have
received, we believe that routine referral of all deaths is the most
effective way to increase organ donation rates substantially.
However, the final rule does not mandate how best practices are to
be applied at the local level. It is designed to maximize organ
donation while allowing local communities a certain amount of
flexibility in applying the rule to their local situation. The rule
takes this approach in order to encourage innovation at the local level
and to assure that successful alternative approaches are not disrupted.
For example, although the final rule specifies that the individual
requesting donation from the family of a potential donor must be
trained in the family consent process, it allows the hospital to decide
whether that individual will be an OPO representative, a tissue bank or
eye bank representative, or a hospital employee and encourages OPOs and
hospitals to collaborate in defining how the process will occur
[Sec. 482.45(a)(3)].
There are a number of sources of information and guidance about the
most recent research in organ donation for OPOs and hospitals that want
to ensure their protocols reflect best practices. One of these is The
Partnership for Organ Donation, Inc., Two Oliver St., Boston, MA 02109-
4901. The Partnership is an independent, nonprofit organization that
sponsors research in organ donation and has worked with hospitals and
[[Page 33869]]
OPOs across the United States to improve organ donation.
The current regulations require the governing board of a hospital
to have a written protocol to identify potential organ donors and carry
out the other requirements of section 1138 of the Act. We have revised
how these requirements are articulated, in keeping with the way in
which we are generally transforming these conditions of participation
for hospitals. The final rule requires that the hospital actually carry
out specified responsibilities. For example, the hospital must contact
the OPO or its designee about every death or imminent death that occurs
in the hospital. This requirement will relieve the hospital of the
responsibility for keeping current with changing potential donor
criteria and determining the medical suitability of potential organ
donors (unless the hospital has an alternative arrangement with its
tissue and eye banks in which the hospital determines the medical
suitability of tissue and eye donors) and will ensure that no potential
donors are missed.
The Commonwealth of Pennsylvania passed legislation effective in
March 1995, requiring that hospitals report all deaths to the OPO. The
OPO for southeastern Pennsylvania, Delaware and southern New Jersey
(Delaware Valley Transplant Program) has seen a 40 percent increase in
organ donation since enactment of the law. In contrast, since 1990, the
organ donation rate nationwide has increased an average of less than 3
percent per year and, as noted above, remained essentially unchanged in
1997. Other OPOs that have instituted routine referral within some
hospitals in their service areas have seen similar, substantial
increases in those hospitals. One OPO reported that two of their
hospitals had their first organ donors in 1997, yielding five organs
for transplantation. Another OPO that uses routine referral has seen
their consent rate for organ donation among African Americans rise from
32.7 percent in 1991 to 68.9 percent in 1997.
The final rule specifies that the hospital must ensure, in
collaboration with the OPO, that the family of each medically suitable
potential donor identified by the OPO is advised of the right to donate
or decline to donate. This provision is based on research that
indicates that consent to organ donation is highest when the formal
request is made by OPO staff or by OPO and hospital staff together
rather than by hospital staff alone. While we require collaboration, we
also recognize that hospital staff may wish to perform this function
and may do so when properly trained. Under this final rule, the
hospital may choose to have OPO staff contact potential donor families,
have hospital and OPO staff jointly perform this function, or rely
exclusively on hospital staff. If hospital staff, rather than organ
procurement coordinators, initiate the request for donation to the
family, it is important that they be trained in best practices for
advising the family of their options and initiating the request for
donation. Therefore, the rule requires that hospital staff who initiate
the request for donation must be designated requestors. A designated
requestor is defined in the regulation as an individual who has
completed a course offered or approved by the OPO and designed in
conjunction with the tissue and eye bank community in the methodology
of approaching potential donor families and requesting organ or tissue
donation. The Pennsylvania routine referral legislation also requires
that hospital employees complete a course in how to approach families
and explain their donation options.
One recent study demonstrated a 47 percent increase in consent
rates when best practices are used. [Gortmaker SL, Beasley CL, Sheey E,
et al, unpublished data] Another recent study demonstrated that
training of hospital staff about protocols for organ donation is
significantly associated with superior rates of organ donation.
However, the study also demonstrated that current levels of training
about organ donation are inadequate. [Evanisko MJ, Beasley, CL,
Brigham, LE ``Readiness of Critical Care Physicians and Nurses to
Handle Requests for Organ Donation.'' American Journal of Critical Care
(1998; 7:4-12]
The final rule requires a hospital to ensure that it works
cooperatively with the OPO, a tissue bank, and an eye bank in educating
staff on donation issues, reviewing death records to improve
identification of potential donors, and maintaining potential donors
during necessary testing and placement of donated organs and tissues
[Sec. 482.45(a)(5)]. Review of death records is the key method an OPO
uses to determine a hospital's donor potential. It allows the hospital
to develop strategies for improving donation and allocating resources
to educate hospital staff. Review of death records also enables
hospitals to recognize missed opportunities for organ donation and to
identify hospital, OPO, and recovery staff who may need additional
education.
The final rule mandates that a hospital have an agreement with at
least one tissue bank and at least one eye bank to cooperate in the
retrieval, processing, preservation, storage, and distribution of
tissues and eyes [Sec. 482.45(a)(2)]. This agreement can be used to
spell out whether the OPO will determine medical suitability for tissue
and eye donation and handle the referral process for tissue and eye
donors or whether an alternative referral process will be used. If the
OPO determines medical suitability and refers tissue and eye donors, it
must do so using the definition of potential tissue and eye donor and a
notification protocol developed in consultation with the tissue bank
and eye bank designated by the hospital. An alternative arrangement
might, for example, specify that the hospital will refer potential
tissue and eye donors directly to the tissue bank and eye bank. We
added these requirements in the final rule to ensure that tissue and
eye banks have potential tissue and eye donors referred to them
appropriately and expeditiously. It is important to note when
discussing agreements between hospitals, tissue banks and eye banks,
that some OPOs are also tissue and/or eye banks. This regulation does
not preclude a hospital from having a single agreement with such an OPO
which encompasses the services the OPO will provide in regard to
organs, tissues, and eyes, in lieu of separate agreements with an OPO,
a tissue bank, and an eye bank.
The final rule stresses cooperation and collaboration between all
parties. It is our expectation that in communities where hospitals,
OPOs, and tissue and eye banks have not yet developed cooperative
relationships, these requirements will encourage all parties to work
together with the best interests of their communities in mind to
establish protocols that will increase organ, tissue, and eye donation
rates.
The final rule requires transplant centers to provide requested
organ-transplant-related data to the OPTN, the Scientific Registry, the
OPO, or the Department, as requested by the Secretary
[Sec. 482.45(b)(3)]. Currently, transplant centers report data to the
OPTN, the OPO, and the Scientific Registry regarding the disposition of
organs made available for transplant. These data include information
regarding why a center declines the offer of a donated organ,
information regarding patients waiting for transplants, information on
those who have received a transplant, follow-up data on patients who
have received a transplant, and information on those offered an organ
for transplant but declining to use the organ at the time. At the time
the proposed rule was published, submission of these data by transplant
centers to the OPTN was voluntary.
[[Page 33870]]
However, a final rule with comment period, Organ Procurement and
Transplantation Network [98-HRSA-01, 63 F.R. 16295, published April 2,
1998, effective October 1, 1998] has made reporting by transplant
centers mandatory. In accordance with 42 CFR 121.11(a)(2) (record
maintenance requirements for OPOs and transplant programs) and
121.11(b)(2) (reporting requirements for OPOs and transplant hospitals)
these programs are required to maintain and report data to the OPTN,
the Scientific Registry, and the Secretary. Therefore, the requirement
in this HCFA final rule, when considered with the requirements in the
OPTN rule, will ensure that data will be available to implement section
1138 of the Act to operate the OPTN and to obtain information from the
Scientific Registry, and to provide information to the Secretary,
patients, their families, physicians, and the public.
V. Regulatory Impact Statement
We have examined the impact of this rule as required by Executive
Order 12866 and the Regulatory Flexibility Act (Public Law 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits, including
potential economic, environmental, public health and safety effects,
distributive impacts, and equity.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 through 612)
requires agencies to analyze options for regulatory relief for small
entities. Consistent with the RFA, we prepare a regulatory flexibility
analysis unless we certify that a rule will not have a significant
economic impact on a substantial number of small entities. For purposes
of the RFA, we treat most hospitals and most other providers,
physicians, health care suppliers, carriers, and intermediaries as
small entities, either by nonprofit status or by having revenues of $5
million or less annually. Individuals and States are not included in
the definition of a small entity.
Also, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. That
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
The Unfunded Mandate Reform Act of 1995 requires (in section 202)
that agencies prepare an assessment of anticipated costs and benefits
for any rule that may result in an annual mandated expenditure by
State, local, and tribal governments, in the aggregate, or by both the
private sector, of $100 million. The notice has no mandated
consequential effect on State, local, tribal governments, or the
private sector and will not create an unfunded mandate.
We have determined that this regulation is economically significant
under E.O. 12866 and a major rule for purposes of Congressional review
of agency rulemaking.
We do not anticipate that the provisions in this final rule will
have a substantial economic impact on most hospitals, including small
rural hospitals. However, we believe it is desirable to inform the
public of our projections of the likely effects of the final rule on
hospitals, small rural hospitals, OPOs, tissue banks, and eye banks.
There are several provisions in this regulation that will impact
hospitals to a greater or lesser degree. Specifically, hospitals will
be required to have written protocols; have agreements with an OPO, a
tissue bank, and an eye bank; refer all deaths that occur in the
hospital to the OPO; ensure that hospital employees who initiate a
request for donation to the family of a potential donor have been
trained as ``designated requestors''; and work cooperatively with the
OPO, tissue bank, and eye bank in educating hospital staff, reviewing
death records, and maintaining potential donors. It is important to
note that because of the inherent flexibility of this regulation, the
extent of the economic impact of most of these requirements is
dependent upon decisions which will be made either by the hospital or
by the hospital in conjunction with the OPO and/or the tissue and eye
banks. Thus, the impact on individual hospitals will vary and is
subject in large part to their decision making. The impact will also
vary according to each hospital's current organ donation protocols and
level of compliance with existing law and regulation. For example,
eight States already have routine referral legislation, and in several
other States, OPOs and hospitals have routine referral agreements.
The first requirement in the regulation is that hospitals have and
implement written protocols that reflect the various provisions of the
regulation. Currently, under section 1138 of the Act and the existing
regulation, hospitals must have written protocols for organ donation.
Most hospitals will need to rewrite their existing protocols to conform
with this regulation; however, this is clearly not a requirement that
imposes a significant economic burden.
In addition, a hospital must have an agreement with its designated
OPO and with at least one tissue bank and at least one eye bank.
Although the current regulation does not specifically require an
agreement with an OPO, hospitals are required under section 1138 of the
Act and the existing regulation to refer all potential donors to an
OPO. Also, the OPO regulation at 42 CFR 486.306 requires, as a
qualification for designation as an OPO, that the OPO have a ``working
relationship'' with at least 75 percent of the hospitals in its service
area that participate in the Medicare and Medicaid programs and that
have an operating room and the equipment and personnel for retrieving
organs. Therefore, presumably most hospitals already have some type of
agreement with their designated OPO. Although hospitals may need to
modify those existing agreements, the need to make modifications would
not impose a significant economic burden. The current regulation does
not require hospitals to have agreements with tissue and eye banks.
However, we must assume most hospitals have agreements with tissue and
eye banks, since hospitals are the source for virtually all tissues and
eyes.
The provision of the regulation that will have the most impact on
hospitals is the requirement to notify the OPO about every death that
occurs in the hospital. Approximately 400 deaths per year occur in the
average hospital in the U.S. If the average notification telephone call
to the OPO takes five minutes, the hospital will need approximately
four person days per year to make the calls. We believe this is a
generous estimate. One OPO has reported that the referral calls
hospitals make to the vendor that handles their referral calls average
one minute, 20 seconds. An OPO in a State with routine referral
estimates the calls they receive from hospitals, on average, last no
more than three to five minutes. (A call about a ventilator dependent
patient might last an hour, but, of course, these calls are
infrequent.)
Most likely, additional time would be needed by the hospital staff
person to annotate the patient record or fill out a form regarding the
disposition of the call. This paperwork should take no more than five
minutes. Therefore, paperwork associated with the call might add
approximately four person days per year.
[[Page 33871]]
In summary, the impact of referring all deaths to the OPO should be
limited to approximately eight person days per year. Thus, the economic
impact for a hospital of referring all deaths will be small. Although
small rural hospitals have fewer staff than the average hospital, there
are also fewer deaths to report. Therefore, the impact on small rural
hospitals of notifying OPOs of all deaths would be commensurately
small.
Under the regulation, a hospital may agree to have the OPO
determine medical suitability for tissue and eye donation or may have
alternative arrangements with a tissue bank and an eye bank. These
alternative arrangements could include the hospital's direct
notification of the tissue and eye bank of potential tissue and eye
donors or direct notification of all deaths. If a hospital chose to
contact both a tissue bank and an eye bank directly on all deaths, it
would need a total of 16 person days per year (i.e., five minutes per
call (four person days) and five minutes for paperwork (four person
days) in order to call both the tissue and eye bank directly). Again,
the impact is small, and the regulation permits the hospital to decide
how this process will take place. Note that many communities already
have a one-phone-call system in place, and this regulation does not
preclude, and in fact encourages, these local systems. Also, some OPOs
are also tissue banks and/or eye banks. A hospital that chose to use
the OPO's tissue and eye bank services in these localities would need
to make only one telephone call on every death.
This regulation requires that the individual who initiates a
request for donation to the family of a potential donor must be an OPO
representative or a ``designated requestor.'' A designated requestor is
an individual who has taken a course offered or approved by the OPO in
the methodology for approaching families of potential donors and
requesting donation. It is difficult to estimate how much hospital
staff time will be needed for designated requestor training, as it is
dependent both upon the length of the course and the number of
employees the hospital wishes to have trained. An OPO in a State with
similar legislation has a one-day training course for its designated
requestors. The Partnership for Organ Donation, an independent,
nonprofit organization that sponsors research in organ donation and
work with hospitals and OPOs to improve organ donation, offers
intensive two-day training for hospital donation teams. Even if the OPO
requires a two-day training course and the hospital wants to have a
sufficient number of designated requestors to ensure that all shifts
are covered, this provision of the regulation would not have a
significant economic impact on hospitals. In addition, the hospital may
choose to have donation requests initiated by the OPO staff rather than
hospital staff, in which case there is no economic impact.
The regulation requires a hospital to work cooperatively with the
OPO, a tissue bank, and an eye bank in educating hospital staff. We do
not believe education of hospital staff will demand a significant
amount of staff time. For example, the Pacific Northwest Transplant
Bank recently worked with the Oregon Health Sciences University to
educate all 400 nurses and all staff physicians, chaplains, social
workers, and medical interpreters. The OPO transplant coordinator gave
a 15-minute presentation highlighting staff responsibilities and
changes in the hospital protocol, with an emphasis on a more sensitive
family approach. Presentations were given at times convenient for the
staff, such as at regular staff meetings and before and after shift
reports. Clearly, such brief educational presentations, even if given
once a year or more often, would not have a significant impact on
hospitals. Also, most OPOs currently have educational programs for
their hospitals. For example, one OPO has one full-time and eight part-
time staff devoted to hospital staff training for the hospitals in
their service area.
The regulation requires a hospital to work cooperatively with the
OPO, a tissue bank, and an eye bank in reviewing death records. Most
OPOs currently conduct extensive hospital death record reviews. The
hospital's assistance is required only to provide lists of hospital
deaths and facilitate access to records.
Finally, the regulation requires a hospital to work cooperatively
with the OPO, a tissue bank, and an eye bank in maintaining potential
donors while necessary testing and placement of potential donated
organs and tissues take place. If this regulation is successful in
increasing organ donation, hospitals will have more brain dead
potential donors to maintain until family consent is obtained and the
donors' organs are removed. As referenced earlier, The OPO for
southeastern Pennsylvania, Delaware and southern New Jersey (Delaware
Valley Transplant Program) has seen a 40 percent increase in organ
donation since enactment of routine referral legislation in
Pennsylvania in 1995. In contrast, since 1990, the organ donation rate
nationwide has increased an average of less than 3 percent per year. Of
course, we must take into account the fact that eight States have some
type of routine referral legislation, although most of it is quite
recent. Therefore, if we assume that this regulation will result in a
more modest increase of 20 percent (10 percent or 548 additional donors
per year) in the two years following the effective date, there will be
approximately 1,096 additional donors in that two-year period (based on
the 5,475 organ donors in 1997). (Note that the goal of the Organ and
Tissue Donation Initiative is an increase in the organ donation rate of
20 percent in two years.) However, since there are approximately 5,200
short stay hospitals in the U.S., the additional number of donors per
hospital would be quite small.
It is possible that because of the final rule, some small rural
hospitals may have their first organ donors. Therefore, we considered
the impact on a rural hospital of maintaining a brain dead potential
donor on a ventilator until the organs can be placed. Small rural
hospitals with full ventilator capability should have no trouble
maintaining a potential donor until the organs are placed. However,
some small rural hospitals have ventilator capability only so that a
patient can be maintained until he or she is transferred to a larger
facility for treatment. These hospitals would have the equipment and
staffing to maintain a potential donor until transfer to another
facility occurs. Many small rural hospitals do not have ventilator
capability and would be unable to maintain a potential donor however,
small rural hospitals without ventilator capability will still be
obligated to notify the OPO, or a third party designated by the OPO, of
all individuals whose death is imminent or who have died in the
hospital. We do not believe there will be a significant impact on small
rural hospitals no matter what their situation--full ventilator
capability, ventilator capability only for patients who are to be
transferred to a larger facility, or no ventilator capability.
It is important to estimate the costs to OPOs of screening the
significant number of additional calls they will receive. There are 63
OPOs that will receive the referral calls generated by the
approximately 2,080,000 hospital deaths per year. This means that the
average OPO will receive 33,016 referral calls per year (90 referral
calls per day). An OPO may choose to hire a third party vendor to
triage the phone calls or may hire staff to handle the calls in-house.
Currently, some OPOs use a combination of systems, with OPO staff
[[Page 33872]]
handling calls received during business hours and a vendor handling
calls received during non-business hours. One OPO that uses a vendor
pays $1,200 per month for the first 300 calls and $3.20 per call for
each additional call. The vendor's staff enters all necessary
information into a database that can be accessed by the OPO and also
contacts the tissue and eye banks on every call. One vendor that
triages calls for a number of OPOs charges $5 to $10 per call,
depending upon the type of services desired.
An OPO that chooses to have calls handled by OPO staff will have
costs for staff training, additional telephone lines and computers, and
computer software upgrades. One OPO in a State with routine referral
legislation, has 70 percent of the 32,000 calls it receives every year
handled by a vendor and the remainder handled by OPO staff. An OPO
representative estimated their start-up costs to be approximately
$40,000. The OPO pays the vendor $180,000 per year and spends $220,000
per year on salary and benefits for the additional staff that is needed
for routine referral. The OPO has also seen their telephone charges
increase by about 50 percent. However, in spite of these costs, the OPO
has maintained its organ acquisition costs below the national average.
A representative from an OPO in a State that recently passed routine
referral legislation called its start-up costs ``significant.''
However, in the seven-month period since the legislation went into
effect, the OPO's organ donors have increased by 70 percent (when
compared to the nine-month period prior to the legislation), while its
organ acquisition cost has risen just 3 percent.
It is clear that set-up costs for OPOs to handle the increased
calls resulting from routine referral are significant. They include
costs for improving communications and computer systems and hiring and
training staff. Likewise, ongoing costs for OPOs of handling the
increased calls are significant. The OPO that pays its vendor $1,200
per month for the first 300 calls and $3.20 per call for each
additional call would spend approximately $105,280 to screen 32,000
calls per year. An OPO that uses a vendor that charges $10 per call
would spend $320,000 per year to screen 32,000 calls. An OPO that uses
both a vendor and OPO staff might spend more than $400,000 per year to
screen 32,000 calls. However, the critical issue is whether the
acquisition cost per organ will increase significantly. The acquisition
cost per organ is a function not only of the cost per call, but the
number of calls required for each organ, given the system set up by the
OPO. Based on the experience of some OPOs in States with routine
referral, these costs are likely to remain the same or increase only
slightly.
We received many comments about the proposed rule which expressed
concern that the regulation would have a negative impact on tissue and
eye banks. A few commenters even predicted that some eye banks would be
forced out of business. However, the final rule contains safeguards to
ensure that OPOs consult with tissue and eye banks in establishing
protocols for identifying and referring tissue and eye donors to the
tissue banks and eye banks chosen by the hospital. Therefore, we do not
believe there will be a significant impact on a substantial number of
tissue and eye banks.
We expect that this regulation will increase tissue and eye
donations as well as organ donations. A study of the impact of the
Pennsylvania routine referral legislation on tissue and eye donations
was presented at the Fourth International Society for Organ Sharing
Congress and Transplant Congress in July 1997. [Nathan, HM, Abrams, J,
Sparkman BA, et al. ``Comprehensive State Legislation Increases Organ
and Tissue Donations'] This study used data from the Delaware Valley
Transplant Program, the OPO for southeastern Pennsylvania, and found
that although the maximum donor age was lowered from <66 to=""><60, tissue="" donations="" increased="" 14="" percent="" from="" 1994="" through="" 1996.="" the="" study="" also="" showed="" that="" eye="" donations="" increased="" 28="" percent="" during="" the="" same="" period,="" despite="" more="" restrictive="" donor="" criteria.="" this="" virtually="" eliminated="" the="" waiting="" list="" for="" suitable="" corneas.="" north="" carolina's="" routine="" referral="" legislation="" became="" effective="" in="" october="" 1997.="" the="" carolina="" organ="" procurement="" agency="" (one="" of="" three="" north="" carolina="" opos)="" has="" seen="" heart="" valve="" donations="" increase="" by="" 109="" percent="" and="" other="" tissue="" donations="" increase="" 114="" percent="" through="" may="" 1998.="" as="" discussed="" earlier,="" we="" expect="" this="" regulation="" will="" result="" in="" an="" additional="" 1,096="" donors="" in="" the="" first="" two="" years="" after="" it="" goes="" into="" effect.="" in="" 1997,="" there="" were="" 3.11="" organs="" transplanted="" for="" every="" organ="" donor="" (17,032="" cadaveric="" transplants="" from="" 5,475="" organ="" donors).="" therefore,="" an="" additional="" 1,096="" donors="" could="" result="" in="" an="" additional="" 3,409="" transplants,="" that="" is,="" an="" additional="" 3,409="" lives="" being="" improved="" or="" saved="" in="" the="" first="" two="" years="" of="" the="" regulation.="" transplants="" are="" performed="" both="" to="" save="" lives="" and="" to="" improve="" the="" quality="" of="" recipients'="" lives.="" in="" the="" case="" of="" kidneys,="" dialysis="" is="" an="" alternative="" to="" transplantation="" for="" extended="" periods="" of="" time.="" therefore,="" for="" most="" patients,="" kidney="" transplantation="" is="" not="" necessary="" for="" survival,="" but="" it="" does="" significantly="" improve="" the="" quality="" of="" the="" transplant="" recipient's="" life.="" physical="" health="" while="" on="" dialysis="" is="" significantly="" impaired,="" and="" dialysis="" imposes="" major="" stresses="" and="" substantial="" inconveniences="" in="" carrying="" out="" normal="" activities.="" of="" the="" 17,032="" transplants="" from="" cadaveric="" donors="" performed="" in="" 1997,="" slightly="" more="" than="" half="" (50.4="" percent),="" or="" 8,584,="" were="" kidney="" transplants.="" for="" all="" other="" organs,="" a="" transplant="" is,="" in="" most="" cases,="" necessary="" for="" survival.="" in="" the="" first="" two="" years,="" this="" regulation="" will="" result="" in="" approximately="" 1,718="" (50.4="" percent="" of="" 3,409)="" lives="" vastly="" improved="" by="" kidney="" transplants="" and="" 1,691="" (49.6="" percent="" of="" 3,409)="" lives="" both="" vastly="" improved="" and="" prolonged="" by="" transplantation="" of="" other="" major="" organs.="" the="" following="" reasoning="" was="" used="" to="" construct="" a="" benefit="" cost="" analysis="" in="" the="" optn="" regulation.="" it="" is="" common,="" in="" benefit="" cost="" analysis,="" to="" use="" a="" concept="" termed="" ``value="" of="" a="" statistical="" life''="" to="" estimate="" in="" monetary="" terms="" the="" benefits="" from="" lives="" saved.="" estimates="" of="" this="" value="" can="" be="" derived="" from="" information="" on="" the="" preferences="" of="" individuals="" for="" reduction="" in="" the="" risk="" of="" death,="" and="" their="" willingness="" to="" pay="" for="" such="" reductions.="" in="" this="" case,="" however,="" it="" is="" important="" to="" take="" into="" account="" two="" major="" factors="" that="" reduce="" the="" usefulness="" of="" a="" statistical="" life="" as="" a="" measure:="" (a)="" most="" organ="" transplant="" recipients="" are="" much="" older="" than="" average="" and="" hence="" gain="" fewer="" years="" than="" would="" average="" beneficiaries="" of="" other="" lifesaving="" interventions,="" and="" (b)="" an="" organ="" transplant="" carries="" a="" substantial="" risk="" of="" either="" the="" graft="" or="" the="" patient="" not="" surviving.="" for="" example,="" according="" to="" historical="" data="" from="" the="" 1997="" annual="" report="" of="" the="" optn="" (page="" 23),="" only="" 62="" percent="" of="" cadaveric="" kidney="" grafts="" survive="" 5="" years,="" and="" only="" 81="" percent="" of="" these="" patients="" survive="" 5="" years="" (patient="" survival="" is="" substantially="" higher="" because="" dialysis="" is="" usually="" an="" option="" if="" the="" organ="" fails).="" five="" year="" patient="" survival="" rates="" for="" livers="" are="" 72="" percent,="" for="" hearts="" 67="" percent,="" and="" for="" lungs="" 43="" percent.="" as="" each="" year="" passes,="" additional="" patients="" die,="" though="" at="" lower="" rates="" than="" in="" the="" first="" year="" or="" two.="" survival="" rates="" have="" improved="" in="" recent="" years,="" but="" the="" statistical="" expectation="" of="" increased="" longevity="" and/or="" graft="" survival="" from="" a="" transplant="" is="" on="" the="" order="" of="" a="" dozen="" years="" (a="" rough="" estimate="" since="" we="" do="" not="" yet="" know="" what="" the="" long-term="" experience="" will="" become),="" not="" the="" 40="" years="" (half="" a="" lifetime)="" that="" underlies="" most="" estimates="" of="" statistical="" lives.="" using="" the="" more="" conservative="" concept="" of="" a="" ``statistical="" life-="" year''="" saved,="" then,="" the="" benefit="" from="" 1,691="" non-renal="" transplant="" recipients="" [[page="" 33873]]="" approximates="" 20,292="" life="" years="" in="" the="" first="" two="" years="" of="" the="" regulation.="" in="" a="" recent="" rulemaking="" on="" tobacco,="" hhs="" estimated="" the="" value="" of="" a="" statistical="" life-year="" at="" about="" $116,000="" (see="" federal="" register="" of="" august="" 28,="" 1996,="" at="" page="" 44576).="" this="" was="" a="" conservative="" estimate="" that="" would="" reasonably="" apply="" to="" organ="" procurement="" and="" transplantation="" (though="" a="" figure="" several="" times="" as="" high="" could="" equally="" reasonably="" be="" used).="" applying="" the="" conservative="" $116,000="" value="" to="" statistical="" life-years="" saved="" by="" non-renal="" organ="" transplants,="" the="" social="" benefit="" from="" 1,687="" non-renal="" transplants="" is="" approximately="" $2,353,872,000="" in="" the="" first="" two="" years="" of="" the="" regulation.="" in="" order="" to="" calculate="" the="" transplantation="" costs="" that="" will="" occur="" because="" of="" this="" regulation,="" we="" have="" used="" five-year="" costs,="" which="" include="" follow-up="" costs.="" the="" optn="" regulation="" uses="" milliman="" and="" robertson's="" estimates="" for="" the="" five-year="" cost="" of="" major="" organ="" transplants="" (adjusted="" for="" survival).="" they="" are="" as="" follows:="" liver,="" $394,000;="" heart,="" $317,000;="" lung,="" $312,000;="" heart-lung,="" $351,000;="" pancreas,="" $149,000;="" and="" kidney="" $172,000.="" according="" to="" hcfa="" actuaries,="" kidney="" transplantation="" costs="" are="" offset="" by="" reductions="" in="" other="" medical="" costs="" over="" time,="" such="" as="" dialysis="" costs.="" in="" 1997,="" 24="" percent="" of="" transplants="" performed="" were="" liver="" transplants,="" 13="" percent="" were="" heart="" transplants,="" 5="" percent="" were="" lung="" transplants,="" 6="" percent="" were="" pancreas="" transplants,="" and="" 1/3="" of="" one="" percent="" were="" heart-lung="" transplants.="" slightly="" more="" than="" half="" of="" all="" major="" organ="" transplants="" in="" 1997="" were="" kidney="" transplants.="" (figures="" are="" approximate.)="" earlier="" we="" postulated="" a="" 20="" percent="" increase="" in="" organ="" donation="" in="" a="" two-year="" period,="" resulting="" in="" an="" additional="" 1,096="" donations="" and="" 3,409="" organs="" transplanted="" in="" the="" first="" two="" years="" after="" the="" effective="" date="" of="" the="" legislation.="" if="" we="" assume="" that="" all="" the="" gains="" from="" the="" regulation="" occur="" in="" the="" first="" two="" years="" (that="" is,="" the="" number="" of="" additional="" donors="" remains="" at="" 1,096="" in="" every="" two-year="" period)="" or="" 584="" per="" year,="" the="" number="" of="" additional="" donors="" due="" to="" this="" regulation="" would="" stand="" at="" approximately="" 2,740="" (5="" years="" x="" 548="" donors="" per="" year)="" in="" a="" five-year="" period,="" and="" the="" number="" of="" additional="" transplants="" would="" stand="" at="" 8,521.="" using="" 1997="" percentages,="" we="" would="" expect="" that="" during="" the="" five="" year="" period="" following="" the="" effective="" date="" of="" this="" regulation,="" there="" would="" be="" an="" additional="" 2,045="" liver="" transplants,="" 1,108="" heart="" transplants,="" 426="" lung="" transplants,="" 28="" heart-lung="" transplants,="" and="" 511="" pancreas="" transplants.="" therefore,="" the="" approximate="" overall="" five-year="" cost="" of="" the="" additional="" non-renal="" organ="" transplants="" would="" be="" as="" follows:="" liver,="" $805,730,000;="" heart,="" $351,236,000;="" lung,="" $132,912,000;="" heart-lung,="" $9,828,000="" and="" pancreas,="" $76,139,000,="" for="" a="" total="" greater="" than="" $1,375,845,000.="" as="" stated="" earlier,="" kidney="" transplant="" costs="" are="" offset="" overtime="" by="" reductions="" in="" other="" medical="" costs,="" such="" as="" kidney="" dialysis.="" therefore,="" we="" did="" not="" include="" the="" costs="" of="" kidney="" transplants="" in="" the="" calculation="" of="" the="" overall="" five="" year="" transplantation="" costs.="" some="" offsetting="" reductions="" in="" medical="" costs="" for="" other="" types="" of="" transplants="" are="" also="" likely,="" but="" are="" not="" as="" readily="" quantifiable.="" we="" also="" calculated="" the="" statistical="" and="" social="" benefits="" from="" the="" 4,118="" non-renal="" transplants="" during="" a="" five-year="" period.="" using="" our="" earlier="" methodology,="" the="" five="" year="" statistical="" and="" social="" benefits="" would="" be="" as="" follows:="" 49,416="" additional="" life-years="" and="" $5,732,256,000="" additional="" social="" benefit.="" below,="" provided="" by="" hcfa="" actuaries,="" are="" estimated="" costs="" to="" the="" medicare="" program="" resulting="" from="" additional="" organ="" transplants.="" estimated="" costs="" to="" the="" medicare="" program="" ------------------------------------------------------------------------="" cost="" fiscal="" year="" (millions)="" ------------------------------------------------------------------------="" 1999.......................................................="" 35="" 2000.......................................................="" 75="" 2001.......................................................="" 115="" 2002.......................................................="" 160="" 2003.......................................................="" 200="" 2004.......................................................="" 240="" ------------------------------------------------------------------------="" these="" estimates="" include="" both="" the="" cost="" of="" the="" transplants="" and="" follow-up="" medical="" care,="" adjusted="" for="" patient="" survival.="" costs="" increase="" every="" year="" because="" each="" year's="" cost="" includes="" transplants="" performed="" in="" that="" year="" plus="" medical="" care="" for="" those="" transplant="" recipients="" who="" received="" transplants="" in="" previous="" years.="" thus,="" the="" impact="" in="" each="" year="" was="" calculated="" as="" the="" sum="" of="" the="" number="" of="" transplants="" in="" that="" year="" plus="" the="" cost="" of="" patient="" graft="" survivals.="" our="" analysis="" indicates="" that="" administrative="" costs="" to="" the="" medicare="" budget="" are="" minimal.="" cost="" estimates="" were="" adjusted="" for:=""> Normal annual percentage increase in organ donation and
transplantation that would occur independent of the impact of this
regulation;
The fact that the Medicare population tends to be sicker
than the general transplant population;
The fact that approximately \1/3\ of kidney transplant
recipients leave Medicare end stage renal disease (ESRD) rolls after
three years if the transplant is successful; and
Reduced costs to the Medicare program for kidney
transplant recipients because they no longer need dialysis.
HCFA actuaries also estimated the cost to the Medicare program of
transplants and follow-up medical care for transplant recipients in FY
2004 without the regulation to be $1,630,000,000. Total costs to the
Medicare program in FY 2004 with this regulation total $1,870,000,000
($1,630,000,000 + $240,000,000). Thus, the regulation will increase the
cost to the Medicare program and associated medical care by
approximately 15 percent in FY 2004.
Note the cost estimate for 1999 does not include the first three
months of FY 1999. Although the regulation's effective date will be in
August 1998, it is not expected that there will be an impact on the
Medicare budget until January 1, 1999.
We attempted to compare the costs to hospitals and OPOs of the
proposed regulation and the final regulation. The proposed regulation
would have permitted OPOs to define both ``potential donor'' and the
notification protocol hospitals would use to refer potential donors. We
cannot quantify the costs of implementing the proposed regulation
because we have no way of knowing with any certainty, what the
individual OPOs would decide to do if given the responsibility of
deciding which deaths would be referred by their hospitals. Some OPOs
might exclude individuals by age; other OPOs might exclude individuals
by clinical category (e.g., HIV positive or metastatic cancer).
However, even absent a comparison of costs, we believe the final
regulation is a more effective mechanism to increasing organ donation.
Referring all deaths is a better approach because it creates a clear
standard for hospitals to follow, it ensures that hospitals will not
erroneously assume that a potential donor should be excluded, it allows
early intervention by the OPO to guide the organ and tissue procurement
process to ensure a successful outcome, and will make it easier to
standardize transplantation waiting time.
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, agencies are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and
[[Page 33874]]
approval. In order to fairly evaluate whether an information collection
should be approved, section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 requires that we solicit comment on the following issues:
Whether the information collection is necessary and useful
to carry out the proper functions of the agency;
The accuracy of the agency's estimate of the information
collection burden;
The quality, utility, and clarity of the information to be
collected; and
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Therefore, we are soliciting public comment on each of these issues
for the information collection requirements summarized and discussed
below.
Section 482.45(a) Standard: Organ Procurement Responsibilities
The burden associated with the requirements of this section
include; (1) the requirement to maintain protocol documentation
demonstrating that the five requirements of this section have been met,
(2) the requirement for a hospital to notify an OPO and/or tissue bank
of a death, and (3) the time required for a hospital to document and
maintain OPO referral information.
We estimate that, on average, the requirement to maintain protocol
documentation demonstrating that the requirements of this section have
been met will impose one hour of burden per hospital (on 5,200
hospitals) on an annual basis (a total of 5,200 annual burden hours).
The burden associated with the requirement for a hospital to notify
an OPO of every death that occurs in the hospital is estimated to be
approximately 400 calls per year in an average hospital, multiplied by
five minutes per call, for a total annual burden of 34 hours per
hospital (a total of 176,800 annual burden hours). We believe this is a
generous estimate. One OPO has reported that the referral calls
hospitals make to the vendor that handles their referral calls average
one minute, 20 seconds. An OPO in a State with routine referral
estimates the calls they receive from hospitals, on average, last no
more than three to five minutes. (A call about a ventilator dependent
patient might last an hour, but, of course, these calls are
infrequent.)
In addition, time would be needed by the hospital staff person to
annotate the patient record or fill out a form regarding the
disposition of the call. The burden associated with this activity is
estimated that be five minutes per call, multiplied by 400 calls, for
an annual burden of 34 burden hours per hospital (a total of 176,800
annual burden hours).
Under the regulation, a hospital may agree to have the OPO
determine medical suitability for tissue and eye donation or may have
alternative arrangements with a tissue bank and an eye bank. These
alternative arrangements could include the hospital's direct
notification of the tissue and eye bank of potential tissue and eye
donors or direct notification of all deaths. If a hospital chose to
contact both a tissue bank and an eye bank directly on all deaths, it
would need an additional 68 annual hours of burden per hospital (a
total of 353,600 annual burden hours), (i.e., five minutes per call and
five minutes for paperwork in order to call both the tissue and eye
bank directly). Again, the impact is presumed to be small, since the
regulation permits the hospital to decide how this process will take
place. It should be noted that many communities already have a one-
phone-call system in place, and this regulation does not preclude, and
in fact encourages, these local systems. Also, some OPOs are also
tissue banks and/or eye banks. A hospital that chose to use the OPO's
tissue and eye bank services in these localities would need to make
only one telephone call on every death.
Section 482.45(b) Standard: Organ Transplantation Responsibilities
If a hospital performs any type of transplants, it must provide
organ-transplant-related data as requested by the Organ Procurement and
Transplantation Network (OPTN), the Scientific Registry (SR), or the
organ procurement organizations (OPOs). The hospital must also provide
such data directly to the Department of Health and Human Services when
requested by the Secretary.
The new reporting requirement imposed with this section, which is
subject to the PRA, is the requirement on an estimated 300 transplant
hospitals to provide data to 63 OPOs. Based upon discussions with
industry representatives the data that will be requested by the OPO's
is data currently requested and supplied by transplant hospitals to the
OPOs. Therefore, we are assigning one token-hour for the burden
associated with this requirement.
The burden related to the requirement for a hospital to provide
data to the OPTN and SR is currently imposed by the Health Resources
and Services Administration and is approved under OMB number 0915-0157,
with an expiration date of 10/31/99. The burden associated with these
requirements ranges from .1 hour to .4 hours per submission, depending
on donor type. On an annual basis the total number of submissions is
285,600 for a total burden of 39,970 hours. The remaining requirement
that data may be requested by the Secretary, would be collected on an
individual basis and/or during the pursuit of an administrative action,
audit, or investigation, and is therefore not subject to the
requirements of the PRA as defined under 5 CFR 1320.3 (h)(6) and
1320.4.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements in Secs. 482.45(a)
and 482.45(b). These requirements are not effective until they have
been approved by OMB.
If you comment on any of these information collection and record
keeping requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Information Technology Investment Management Group, Division of HCFA
Enterprise Standards, Room C2-26-17, 7500 Security Boulevard,
Baltimore, MD 21244-1850. Attn.: John Burke HCFA-3005-P
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503. Attn.: Allison Herron Eydt, HCFA Desk Officer
List of Subjects in 42 CFR Part 482
Grant programs-health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements.
For reasons set forth in the preamble, 42 CFR chapter IV is amended
as follows:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
1. The authority citation for part 482 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh), unless otherwise noted.
Subpart B--Administration
Sec. 482.12 [Amended]
2. In Sec. 482.12, paragraph (c)(5) is removed.
Subpart C--Basic Hospital Functions
3. A new Sec. 482.45 is added to subpart C to read as follows:
[[Page 33875]]
Sec. 482.45 Condition of participation: Organ, tissue, and eye
procurement
(a) Standard: Organ procurement responsibilities. The hospital must
have and implement written protocols that:
(1) Incorporate an agreement with an OPO designated under part 486
of this chapter, under which it must notify, in a timely manner, the
OPO or a third party designated by the OPO of individuals whose death
is imminent or who have died in the hospital. The OPO determines
medical suitability for organ donation and, in the absence of
alternative arrangements by the hospital, the OPO determines medical
suitability for tissue and eye donation, using the definition of
potential tissue and eye donor and the notification protocol developed
in consultation with the tissue and eye banks identified by the
hospital for this purpose;
(2) Incorporate an agreement with at least one tissue bank and at
least one eye bank to cooperate in the retrieval, processing,
preservation, storage and distribution of tissues and eyes, as may be
appropriate to assure that all usable tissues and eyes are obtained
from potential donors, insofar as such an agreement does not interfere
with organ procurement;
(3) Ensure, in collaboration with the designated OPO, that the
family of each potential donor is informed of its options to donate
organs, tissues, or eyes or to decline to donate. The individual
designated by the hospital to initiate the request to the family must
be an organ procurement representative or a designated requestor. A
designated requestor is an individual who has completed a course
offered or approved by the OPO and designed in conjunction with the
tissue and eye bank community in the methodology for approaching
potential donor families and requesting organ or tissue donation;
(4) Encourage discretion and sensitivity with respect to the
circumstances, views, and beliefs of the families of potential donors;
(5) Ensure that the hospital works cooperatively with the
designated OPO, tissue bank and eye bank in educating staff on donation
issues, reviewing death records to improve identification of potential
donors, and maintaining potential donors while necessary testing and
placement of potential donated organs, tissues, and eyes take place.
(b) Standard: Organ transplantation responsibilities. (1) A
hospital in which organ transplants are performed must be a member of
the Organ Procurement and Transplantation Network (OPTN) established
and operated in accordance with section 372 of the Public Health
Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term
``rules of the OPTN'' means those rules provided for in regulations
issued by the Secretary in accordance with section 372 of the PHS Act
which are enforceable under 42 CFR 121.10. No hospital is considered to
be out of compliance with section 1138(a)(1)(B) of the Act, or with the
requirements of this paragraph, unless the Secretary has given the OPTN
formal notice that he or she approves the decision to exclude the
hospital from the OPTN and has notified the hospital in writing.
(2) For purposes of these standards, the term ``organ'' means a
human kidney, liver, heart, lung, or pancreas.
(3) If a hospital performs any type of transplants, it must provide
organ-transplant-related data, as requested by the OPTN, the Scientific
Registry, and the OPOs. The hospital must also provide such data
directly to the Department when requested by the Secretary.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare
Hospital Insurance; Program No. 93.778, Medical Assistance Program)
Dated: June 15, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
Dated: June 16, 1998.
Donna E. Shalala,
Secretary.
[FR Doc. 98-16490 Filed 6-17-98; 10:12 am]
BILLING CODE 4120-01-P
