33856 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

part 300 which is the National Oil and

Hazardous Substances Pollution

Contingency Plan (NCP), which EPA

promulgated pursuant to section 105 of

the Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA) of 1980, as amended.

EPA and the Florida Department of

Environmental Protection (FDEP) have

determined that the Site poses no

significant threat to public health or the

environment and therefore, further

response measures pursuant to CERCLA

are not appropriate.

DATES: Effective June 22, 1998.

ADDRESSES: Comprehensive information

on this Site is available through the EPA

Region 4 public docket, which is

available for viewing at the information

repositories at two locations. Locations,

contacts, phone numbers and viewing

hours are:

Record Center, U.S. EPA Region 4, 61

Forsyth Street, Atlanta, Georgia

30303–8909, Phone: (404) 562–9530,

Hours: 8:00 a.m. to 4:00 p.m., Monday

through Friday—By Appointment

Only; and

Media Center, George Stone Vocational

School, 2400 Longleaf Drive,

Pensacola, Florida 32526–8922,

Phone: (850) 944–1424, Hours: 8:00

a.m. to 9:00 p.m., Monday through

Friday.

FOR FURTHER INFORMATION CONTACT:

Randa Chichakli, U.S. EPA Region 4,

Waste Management Division, 61 Forsyth

Street, Atlanta, Georgia 30303–8909,

(404) 562–8928.

SUPPLEMENTARY INFORMATION: EPA

announces the deletion of the Beulah

Landfill Superfund Site in Pensacola,

Escambia County, Florida from the NPL,

which constitutes Appendix B of the

NCP, 40 CFR part 300. EPA identifies

sites on the NPL that appear to present

a significant risk to public health,

welfare, or the environment. Sites on

the NPL may be the subject of remedial

actions financed by the Hazardous

Substances Superfund Response Trust

Fund (Fund). Pursuant to section

300.425(e)(3) of the NCP, any site

deleted from the NPL remains eligible

for Fund-financed Remedial Actions if

conditions at the site warrant such

action. EPA published a Notice of Intent

to Delete the Beulah Landfill Superfund

Site from the NPL on April 24, 1998 in

the Federal Register, (63 FR 20361–

20362). EPA received no comments on

the proposed deletion; therefore, no

responsiveness summary is necessary

for attachment to this Notice of

Deletion. Deletion of a site from the NPL

does not affect the responsible party

liability or impede agency efforts to

recover costs associated with response

efforts.

List of Subjects in 40 CFR Part 300

Environmental protection, Air

pollution control, Chemicals, Hazardous

substances, Hazardous waste,

Intergovernmental relations, penalties,

superfund, Water pollution control,

Water supply.

Dated: June 10, 1998.

A. Stanley Meiburg,

Acting Regional Administrator, Region 4.

40 CFR part 300 is amended as

follows:

PART 300—[AMENDED]

1. The authority citation for part 300

continues to read as follows:

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C.

9601–9657; E.O. 12777, 56 FR 54757, 3 CFR,

1991 Comp., p. 351; E.O. 12580, 52 FR 2923,

3 CFR, 1987 Comp., p. 193.

Appendix B [Amended]

2. Table 1 of Appendix B to part 300

is amended by removing the site

‘‘Beulah Landfill, Pensacola, FL.’’

[FR Doc. 98–16252 Filed 6–19–98; 8:45 am]

BILLING CODE 6560–50–P

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.

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.

SUPPLEMENTARY INFORMATION:Copies: To

order copies of the Federal Register

containing this document, send your

request to: New Orders, Superintendent

of Documents, P.O. Box 37194,

Pittsburgh, PA 15250–7954. Specify the

date of the issue requested and enclose

a check or money order payable to the

Superintendent of Documents, or

enclose your Visa or Master Card

number and expiration date. Credit card

orders can also be placed by calling the

order desk at (202) 512–1800 or by

faxing to (202) 512–2250. The cost for

each copy is $8. As an alternative, you

can view and photocopy the Federal

Register document at most libraries

designated as Federal Deposit Libraries

and at many other public and academic

libraries throughout the country that

receive the Federal Register.

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.
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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
33858 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 nonproprietary 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.
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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 onephone-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
33860 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 hospitalbased health professional, but the
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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
33862 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 nonsurvivable 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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
33864 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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 braindead patients are maintained until a

referral is made and are not referred to

the OPO after mechanical support has

been discontinued.
33866 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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-todate 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 nontransplant 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 § 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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.
33868 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 § 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 § 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 [§ 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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

[§ 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

[§ 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 organtransplant-related data to the OPTN, the

Scientific Registry, the OPO, or the

Department, as requested by the

Secretary [§ 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.
33870 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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.
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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 inhouse. Currently, some OPOs use a

combination of systems, with OPO staff
33872 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 ninemonth 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
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 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; heartlung, $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 lifeyears 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

Fiscal year Cost

(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
33874 Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations

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 organtransplant-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 §§ 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

§ 482.12 [Amended]

2. In § 482.12, paragraph (c)(5) is

removed.

Subpart C—Basic Hospital Functions

3. A new § 482.45 is added to subpart

C to read as follows:
Federal Register / Vol. 63, No. 119 / Monday, June 22, 1998 /Rules and Regulations 33875

§ 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 organtransplant-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

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Parts 73 and 74

[MM Docket No. 98–93; FCC 98–117]

1998 Biennial Regulatory Review—

Streamlining of Radio Technical Rules

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: On June 15, 1998, the

Commission released a Notice of

Proposed Rule Making and Order. The

Commission adopted a number of

changes in this proceeding to promote

greater technical flexibility in the FM

service and to streamline and expedite

the processing of applications in several

services.

EFFECTIVE DATE: July 22, 1998.

FOR FURTHER INFORMATION CONTACT:

Peter Doyle, Dale Bickel or William

Scher, Audio Services Division, Mass

Media Bureau (202) 418–2780.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s Notice of

Proposed Rule Making and Order

(Order) in MM Docket No. 98–93 and

FCC No. 98–117, adopted June 11, 1998

and released June 15, 1998. The

complete text of this Order is available

for inspection and copying during

regular business hours in the FCC

Reference Center (Room 239), 1919 M

St., N.W., Washington, D.C. 20554 and

may also be purchased from the

Commission’s copy contractor,

International Transcription Service,

(202) 857–3800 (phone), (202) 857–3805

(facsimile), 1231 20th St., N.W.,

Washington, D.C. 20036.

Synopsis of Order

1. The Commission is making a

number of amendments to the FM

technical rules in order to clarify

existing rules. Because these

amendments are non-controversial and

will have no adverse effect on any party,

we find that notice and comment

procedures are unnecessary and need

not be followed prior to their adoption.

Ordering Clauses

2. Accordingly, it is ordered, that

these minor rule changes shall become

effective July 22, 1998.

List of Subjects

47 CFR Part 73

Radio, reporting and recordkeeping

requirements.

47 CFR Part 74

Radio, reporting and recordkeeping

requirements.

Federal Communications Commission.

William F. Caton,

Deputy Secretary.

Rule Changes

Accordingly, Parts 73 and 74 of Title

47 of the Code of Federal Regulations

are amended as follows:

PART 73—RADIO BROADCAST

SERVICES

1. The authority citation for part 73

continues to read as follows:

Authority: 47 U.S.C. 154, 303, 334 and 336.

2. Amend § 73.45 by revising

paragraph (c) introductory text and

paragraph (c)(2) to read as follows:

§ 73.45 AM antenna systems.

* * * * *

(c) Should any changes be made or

otherwise occur which would possibly

alter the resistance of the antenna

system, the licensee must commence the

determination of the operating power by