[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