6086 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 413, 441, 486 and 498

[CMS–3064–P] 

RIN: 0938–AK81

Medicare and Medicaid Programs; 

Conditions for Coverage for Organ 

Procurement Organizations (OPOs)

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would 

establish new conditions for coverage 

for organ procurement organizations 

(OPOs), including multiple new 

outcome and process performance 

measures based on donor potential and 

other related factors in each service area 

of qualified OPOs. We are proposing 

new standards with the goal of 

improving OPO performance and 

increasing organ donation.

DATES: We will consider comments if 

we receive them at the appropriate 

address, as provided below, no later 

than 5 p.m. on April 5, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–3064–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates please): 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: Centers 

for Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3064–P, P.O. 

Box 8015, Baltimore, MD 21244–8015. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.) 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by mailing 

your comments to the addresses 

provided at the end of the ‘‘Collection 

of Information Requirements’’ section in 

this document.

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Marcia Newton, (410) 786–5265. Diane 

Corning, (410) 786–8486.

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–3064–P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. CMS posts all electronic 

comments received before the close of 

the comment period on its public Web 

site as soon as possible after they have 

been received. Hard copy comments 

received timely will be available for 

public inspection as they are received, 

generally beginning approximately 3 

weeks after publication of a document, 

at the headquarters of the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to 

view public comments, phone 1–800–

743–3951. 

I. Background 

A. Key Statutory Provisions 

The Organ Procurement Organization 

Certification Act of 2000 (section 701 of 

Pub. L. 106–505) and section 219 of the 

Conference Report accompanying the 

Consolidated Appropriations Act, 2001 

(Pub. L. 106–554) contain identical 

provisions that amended section 

371(b)(1) of the Public Health Service 

(PHS) Act (42 U.S.C. 273(b)(1)). The 

legislation directs the Secretary to 

establish regulations that include four 

major requirements. These are to: 

1. Increase the re-certification cycle 

for OPOs from 2 to at least 4 years. 

2. Establish outcome and process 

performance measures based on 

empirical evidence, obtained through 

reasonable efforts, of organ donor 

potential and other related factors in 

each service area of qualified OPOs. 

3. Establish multiple outcome 

measures. 

4. Establish a process for OPOs to 

appeal a de-certification on substantive 

and procedural grounds. 

The re-certification cycle was 

increased from 2 years to 4 years 

through an interim final rule with 

comment (December 28, 2001, 66 FR 

67109), ‘‘Emergency Re-certification for 

Coverage for Organ Procurement 

Organizations (OPOs).’’ The interim 

final rule re-certified all 59 OPOs until 

December 31, 2005 and extended their 

agreements with us until July 31, 2006. 

Thus, the re-certification cycle set forth 

in the interim final rule satisfies the first 

of the new criteria (that is, certification 

not more frequently than once every 4 

years.) Our proposed rule addresses the 

remaining three requirements. 

Section 1138 of the Social Security 

Act (the Act) (42 U.S.C. 1320b–8) 

provides the statutory qualifications and 

requirements that an OPO must meet in 

order for organ procurement costs to be 

reimbursed in hospitals and critical 

access hospitals under the Medicare or 

Medicaid programs. Section 1138(b) of 

the Act also specifies that an OPO must 

operate under a grant made under 

section 371(a) of the PHS Act or must 

be certified or re-certified by the 

Secretary as meeting the standards to be 

a qualified OPO. Under these 

authorities, we previously established 

conditions for coverage for OPOs at 42 

CFR 486.301, et seq. (May 2, 1996, 61 

FR 19722).

Section 1102 of the Act gives the 

Secretary of Health and Human Services 

the authority to make and publish such 

rules and regulations as may be 

necessary to the efficient administration 

of the functions with which he is 

charged under the Act. This section of 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6087

the Act gives the Secretary broad 

authority to establish requirements for 

OPOs that are necessary for the efficient 

administration of the Medicare program. 

B. Why We Are Proposing New OPO 

Regulations 

OPOs are government contractors that 

play a crucial role in ensuring that 

scarce transplantable human organs are 

provided to seriously ill patients 

suffering from end-stage organ failure. 

OPOs are responsible for identifying 

potential organ donors, informing 

families about their donation options, 

obtaining consent to donation, screening 

potential donors for infectious disease, 

clinically managing potential organ 

donors to maintain viability of their 

organs, placing the maximum number of 

organs possible with transplant centers, 

arranging for recovery, testing, and 

tissue typing of organs, and packaging 

and transporting organs to transplant 

hospitals. Clearly, OPO performance is 

one of the most critical elements of the 

nation’s organ transplantation system. 

An OPO that is effective in procuring 

organs and delivering them safely to 

transplant centers will save more lives 

than an ineffective OPO. Therefore, 

under the broad authority in the statute, 

the Secretary has established 

performance standards for OPOs so that 

they excel in their critical mission. 

The need for organ donors is acute 

and growing rapidly. While medical 

advances have made transplantation a 

viable treatment option for many 

patients suffering from end-stage organ 

failure, the supply of organs has not 

kept pace with the number of patients 

who need them. Since 1996 when the 

current OPO regulations went into effect 

through the end of 2002, the number of 

patients waiting for organs increased by 

nearly 60 percent to more than 80,792, 

while the number of deceased donors 

grew by only 14 percent. As of June 23, 

2003, there were 82,049 patients waiting 

for a transplant. 

Various studies, including those by 

the Harvard School of Public Health, the 

Partnership for Organ Donation, and the 

Association of Organ Procurement 

Organizations (AOPO), have estimated 

that approximately 10,500 to 22,000 

deaths occurring in the United States 

every year could yield suitable donor 

organs. (C Christiansen, S Gortmaker, J 

William, et al: A Method for Estimating 

Solid Organ Donor Potential by Organ 

Procurement Region, American Journal 

of Public Health, Vol. 88, No. 22, 

November, 1998. E Sheey, S Conrad, L 

Brigham, et al: Estimating the Number 

of Potential Organ Donors in the United 

States, The New England Journal of 

Medicine, 349:667–74, August 14, 2003. 

E Guadagnoli, C Christiansen, C 

Beasley, Potential Organ-Donor Supply 

and Efficiency of Organ Procurement 

Organizations, Health Care Financing 

Review, Vol. 24, No. 24, Summer 2003.) 

However, there were only 6,182 

deceased donors in 2002 and only 

18,244 transplants resulting from those 

donations. Based on these estimates, 

OPOs are recovering organs from, at 

most, only a little more than half the 

number of potential donors per year. 

The study published in The New 

England Journal of Medicine found that 

of all potential organ donors reported in 

the study, only 42 percent became 

donors. Of those families who were 

asked to donate, only 39 percent agreed, 

and 16 percent of families were never 

asked whether they would agree to 

donation. The study published in the 

Health Care Financing Review found 

that of all potential organ donors 

reported in the study, only 35 percent 

became donors. 

Over the years, many research studies 

have analyzed factors that impact 

donation rates, including health 

professionals’ attitudes toward 

donation, the setting in which requests 

for donation are made, and medical 

examiner prohibitions on donation. 

Recently, researchers have increasingly 

turned their attention to the best 

practices of OPOs whose service areas 

have high donation rates.

In April 2003, the Health Resources 

and Services Administration (HRSA) 

began an ongoing ‘‘Organ Donation 

Breakthrough Collaborative’’ to bring 

best practices in organ donation to 

OPOs and hospitals, particularly to 

hospitals identified as having the 

greatest number of potential donors. 

More than three-quarters of the 59 OPOs 

are participating in the Collaborative. By 

studying the practices of six of the bestperforming OPOs, the Collaborative’s 

researchers have already identified 

several best practices for OPOs, as well 

as strategies for implementing them. 

Many of the best practices and 

associated strategies are discussed 

throughout this preamble to provide 

guidance for OPOs in implementing the 

requirements of the proposed rule. 

Our proposals would fundamentally 

change the existing OPO regulations to 

emphasize quality and continuous 

quality improvement. The changes 

would ensure that each OPO utilizes 

best practices to improve its efficiency, 

effectiveness, and quality. While the 

requirements in the proposed rule apply 

to all OPOs, we have specifically 

targeted the requirements toward OPOs 

that may not understand the value of 

incorporating best practices into the 

structure of their organizations. Thus, 

our overall goal is to improve the 

functioning of poor performing OPOs, 

rather than simply to terminate them. 

In April 2001, the Department of 

Health and Human Services (the 

Department) launched ‘‘The Secretary’s 

Donation Initiative,’’ a multi-pronged 

effort to increase all types of donation—

blood, marrow, tissue, and organ. In his 

speech launching the Initiative, the 

Secretary noted, ‘‘The facts are just 

astounding. Someone dies every 96 

minutes because there aren’t enough 

organs to go around.’’ The five initial 

key elements of the Initiative were the 

Workplace Partnership for Life, a new 

model donor card, a national forum on 

donor registries, a national gift of life 

medal, and a drivers’ education 

donation curriculum. The Department 

promised that it would launch 

additional elements under the Initiative 

in the future. The Organ Donation 

Breakthrough Collaborative is the sixth 

key element of the Secretary’s Initiative. 

The Secretary believes promulgation of 

the multiple outcome and process 

performance measures in this rule will 

improve OPO performance and, as a 

result, increase organ donation and 

transplantation in the United States. 

B. Overview of Key Proposed Provisions 

1. Appeals and Competition Processes 

In the congressional findings 

associated with section 219 of the 

Conference Report accompanying the 

Consolidated Appropriations Act, 2001 

(42 U.S.C. 219(a)(2)) Congress found 

that the process for OPO re-certification 

created a level of uncertainty among 

OPOs that interfered with their 

effectiveness in increasing organ 

donation. Therefore, Congress directed 

the Secretary to develop a process for 

OPOs to appeal a de-certification on 

substantive and procedural grounds. 

(See section 219(c)(3) codified at 42 

U.S.C. 273(b)(1)(D)(ii)(iv).) Under this 

authority, we are proposing a 

streamlined appeals process, in which 

an OPO facing de-certification could 

appeal and receive a decision on its 

appeal before its service area is opened 

for competition from other OPOs. (See 

proposed § 486.314.) 

To further reduce the level of 

uncertainty identified by Congress, we 

propose making certain changes in the 

current re-certification process. 

Although we would open every OPO’s 

service area for competition at the end 

of every re-certification cycle as under 

the current regulations, we would: (1) 

Permit OPOs to compete for open areas 

only if they met certain specific 

objective criteria; (2) allow competition 

only for entire service areas; and (3) use 

6088 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

clear, objective criteria for determining 

which OPO would be designated for the 

service area (See proposed § 486.316.)

A more extensive discussion of our 

proposal for the appeals and 

competition processes, as well as a 

description of other competition 

processes on which we are requesting 

comments, can be found in this 

preamble under proposed ‘‘General 

Requirements.’’

2. Proposed Multiple Outcome 

Performance Measures 

When we published the current OPO 

regulations in 1996, population was the 

only measure readily available to assess 

donor potential. Therefore, we 

promulgated regulations that judge an 

OPO’s performance based on the 

population in its service area (for 

example, the number of donors per 

million population). Subsequently, we 

began to investigate alternative methods 

for assessing donor potential in order to 

develop new outcome measures based 

on the organ donation potential in each 

OPO’s service area. This preamble 

contains a discussion of our analysis of 

these alternative methods, as well as an 

explanation of the method we propose—

using potential donor data reported by 

OPOs to the Organ Procurement and 

Transplantation Network (OPTN) based 

on information from hospital referral 

calls to OPOs. A discussion of the 

proposed multiple outcome measures 

can be found in this preamble under 

‘‘OPO Outcome Performance Measures.’’

The proposed regulatory text can be 

found at § 486.318. 

The proposed outcome measures 

would address two requirements of the 

Organ Procurement Organization 

Certification Act of 2000 and section 

219 of the Consolidated Appropriations 

Act, 2001. The first requirement calls for 

promulgation of 

‘‘outcome* * *performance measures 

that are based on empirical evidence 

obtained through reasonable efforts of 

organ donor potential and other related 

factors in each service area of qualified 

organ procurement organizations.’’ The 

second requirement calls for the use of 

‘‘multiple outcome measures as part of 

the certification process.’’

3. Proposed Multiple Process 

Performance Measures 

In addition to proposing multiple 

outcome measures, the Organ 

Procurement Organization Certification 

Act of 2000 and section 219 of the 

Consolidated Appropriations Act, 2001 

require the Secretary to propose 

‘‘process performance measures that are 

based on empirical evidence obtained 

through reasonable efforts of organ 

donor potential and other related factors 

in each service area of qualified organ 

procurement organizations.’’ In the 

congressional findings associated with 

section 219 of the Conference Report 

accompanying the Consolidated 

Appropriations Act, 2001 (Pub. L. 106–

554, 42 U.S.C. 219(a)(6)(B)), Congress 

urged us to ‘‘improve the overall 

certification process’’ by incorporating 

process as well as outcome performance 

measures. Congress noted that current 

OPO regulations do not permit 

consideration of outcome and process 

performance measures that ‘‘would 

more accurately reflect the relative 

capability and performance of each 

organ procurement organization.’’

Therefore, we propose to establish 

outcome and process performancerelated measures based on factors that 

affect an OPO’s ability to provide the 

maximum number of healthy organs to 

transplant centers. The purpose of these 

measures is to improve OPO 

performance and increase organ 

donation by ensuring that OPOs attain 

the highest possible level of 

effectiveness and quality. The process 

performance measures we propose 

would require OPOs to develop 

performance protocols, monitor their 

own performance continuously, and 

make changes to improve the quality of 

their organizations. 

The proposed new process 

performance measures are based on 

empirical evidence of organ donor 

potential and other related factors in 

each OPO service area derived from 

three bodies of knowledge: (1) Research 

into best practices in organ donation, (2) 

information about methods of 

maximizing organ donation based on 

our work with OPOs, and (3) accepted 

standards of practice and quality 

improvement strategies used by the 

larger health care community. 

A review of the literature on best 

practices in organ donation provides 

empirical evidence that certain 

characteristics are common to 

successful OPOs. These characteristics 

include experienced leadership; 

efficient mechanisms for tracking 

activity; excellent communication with 

transplant hospitals; timely, on-site 

response to donor referrals; adequate 

experienced staff; data-driven decision 

making; in-hospital coordinators; and 

targeted hospital development 

programs. We have incorporated 

findings from the literature into the 

proposed process performance 

measures. Discussions and citations of 

individual studies can be found in this 

preamble in ‘‘Organ Procurement 

Organization Process Performance 

Measures.’’

Our experience with top-performing 

OPOs supports the validity of the 

literature on best practices. In 1998, we 

developed four ‘‘OPO Coordinator’’

positions in the four CMS Regional 

Consortia (Midwest, West, South, and 

Northeast). The OPO Coordinator 

positions are unique; OPOs are the only 

Medicare providers or suppliers that 

have our staff assigned to work with 

them on an ongoing basis to improve 

their quality and outcomes. The 

Coordinators sponsor seminars, conduct 

conferences and workshops, provide 

education for OPO staffs, conduct site 

visits, meet with OPO directors and 

hospital development staffs, recommend 

interventions to increase OPO efficiency 

and quality, analyze OPO’s voluntary 

quality improvement efforts, and act as 

liaisons between OPOs and hospitals 

and between OPOs and tissue banks to 

resolve problems and promote 

cooperation. (We would note that for 

ease of use, the term ‘‘tissue bank’’

when used in this preamble and in the 

proposed regulations text refers to all 

types of tissue banks, including those 

that recover only corneas and eyes, and 

the word ‘‘tissues’’ refers to all types of 

tissues, including corneas and eyes.) 

The proposed process performance 

measures are based heavily on the 

Coordinators’ extensive experience with 

all 59 OPOs. The Coordinators’

experience with and knowledge about 

OPOs provide much of the empirical 

evidence that has enabled us to develop 

proposed process performance measures 

targeted specifically toward increasing 

OPO performance and quality. 

As stated earlier, some of the 

proposed requirements are based on 

other factors such as accepted standards 

of practice for all health care 

organizations. For example, proposed 

§ 486.344 would require OPOs to use 

accepted standards of practice for 

testing donors to prevent transmission 

of the human immunodeficiency virus 

(HIV) and other infectious diseases. 

Proposed § 486.348 is based on quality 

assessment and performance 

improvement (QAPI) programs that have 

been embraced by the health care 

community and that have been shown 

to increase quality and outcomes of 

care. 

Therefore, the process performance 

measures we propose would satisfy the 

second requirement in the Organ 

Procurement Organization Certification 

Act of 2000 and section 219 of the 

Consolidated Appropriations Act, 2001 

for the Secretary to propose process 

performance measures ‘‘based on 

empirical evidence, obtained through 

reasonable efforts, of organ donor 

potential and other related factors in 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6089

each OPO’s service area.’’ These include 

the following proposed requirements for 

OPOs: 

• Have agreements with hospitals and 

critical access hospitals that address 

responsibilities in regard to the 

requirements for hospitals at § 482.45 

and for critical access hospitals at 

§ 485.643. (§ 486.322.) 

• Maintain sufficient qualified staff 

(either from the OPO or under contract 

or arrangement) to accomplish a number 

of different objectives, including 

screening referral calls for donor 

potential, assessment of potential 

donors for medical suitability, 

requesting consent, maintaining donors, 

placing organs, overseeing organ 

recovery, performing death record 

reviews, and conducting QAPI 

activities. (§ 486.326.) 

• Ensure that organ recovery 

personnel are qualified and trained. 

(§ 486.326.) 

• Provide education, training, and 

performance evaluations for OPO staff. 

(§ 486.326.) 

• Obtain informed consent for organ 

and tissue donation. (§ 486.342.) 

• Develop and follow protocols for 

donor evaluation and management and 

organ placement and recovery. 

(§ 486.344.)

• Have a medical director who is 

responsible for implementation of these 

protocols, as well as oversight 

management of potential donors. 

(§ 486.326.) 

• Arrange for screening and testing of 

the donor for infectious disease and 

testing and tissue typing of organs by a 

laboratory certified under the Clinical 

Laboratory Improvement Amendments 

(CLIA) of 1998. (§ 486.344 and 

§ 486.346.) 

• Collaborate with transplant 

programs and have protocols defining 

OPO and transplant hospital roles and 

responsibilities for donor evaluation, 

donor management, organ recovery, and 

organ placement. (§ 486.344.) 

• Document recipient information, 

including blood type and position on 

the wait list, before organ recovery. 

(§ 486.344.) 

• Develop and follow a protocol for 

packaging, labeling, handling, and 

shipping organs. (§ 486.346.) 

• Establish a comprehensive, datadriven, QAPI program designed to 

monitor and evaluate performance of all 

donation services. (§ 486.348.) 

• Perform death record reviews in 

hospitals with level I or level II trauma 

centers or 150 or more beds. (§ 486.348.) 

In addition, we propose a number of 

other requirements based on the 

Secretary’s authority under section 1102 

of the Act to establish requirements 

necessary for the efficient 

administration of the Medicare program. 

These requirements generally are related 

to (1) administrative matters (because 

efficient administration by Medicare 

contractors such as OPOs supports 

efficient administration of the Medicare 

program); (2) OPOs’ relationships with 

Medicare donor and transplant 

hospitals; and (3) data collection, 

management, and reporting (because 

OPO data are needed by other Medicare 

entities, by other agencies within the 

Department, and by us for the 

certification of OPOs.) These proposed 

requirements include: 

• Participation in the Organ 

Procurement and Transplantation 

Network. (§ 486.320.) 

• Designated requestor training for 

hospital staffs. (§ 486.322.) 

• Legal authority of a governing body 

for management and provision of OPO 

services and development and 

implementation of policies and 

procedures for administration of the 

OPO, the OPO’s QAPI program, and 

services furnished under contract or 

arrangement. (§ 486.324.)

• Conflict of interest policies for the 

governing body, OPO directors, medical 

directors, senior management, and 

procurement coordinators. (§ 486.324 

and § 486.326.) 

• Credentialing records for organ 

recovery personnel. (§ 486.326.) 

• Hospital-specific organ donation 

and transplantation data reported to 

Secretary and public. (§ 486.328.) 

• Information management, including 

donor and transplant recipient 

information, data retention, and format 

of records. (§ 486.330.) 

• A system to allocate donated organs 

that is consistent with the rules and 

requirements of the OPTN. (§ 486.344.) 

• Investigation, analysis, and 

reporting of adverse events to us. 

(§ 486.348.) 

Some of the proposed process 

performance measurements have a dual 

role in that they both satisfy the 

requirements of the Organ Procurement 

Organization Certification Act of 2000 

and section 219 of the Consolidated 

Appropriations Act, 2001 and are based 

on the Secretary’s authority under 

section 1102 of the Act. For example, 

the requirement for OPOs to provide 

designated requestor training for 

hospitals can be linked to the Organ 

Procurement Organization Certification 

Act of 2000 and section 219 of the 

Consolidated Appropriations Act, 2001 

because the requirement is based on 

empirical evidence that shows 

improved consent rates when the OPO 

and hospital collaborate in requesting 

consent. (Note that factors in each 

OPO’s service area, such as the OPO’s 

relationship with its hospitals, would 

determine whether hospitals would 

request, and OPOs would need to 

provide, designated requestor training). 

This proposed requirement also is 

necessary to the effective and efficient 

administration of the Medicare and 

Medicaid programs because under 42 

CFR § 482.45, hospitals must ensure that 

individuals who discuss donation with 

families of potential organ donors are 

trained in a course offered or approved 

by the OPO. 

Finally, section 1138(b)(1)(A) of the 

Act requires an OPO to be a ‘‘qualified’’

OPO as described in section 371(b) of 

the PHS Act. A number of the 

requirements we propose (for example, 

arrangements to cooperate with tissue 

banks and membership composition and 

authority of OPO boards) are based on 

requirements for qualified OPOs under 

the PHS Act. (See § 486.322 and 

§ 486.324.) Proposed requirements that 

relate to the PHS Act are noted in the 

broader discussion in this preamble 

under ‘‘Proposed Process Performance 

Measures and Other Requirements.’’

II. Provisions of the Proposed 

Regulations 

For the reasons discussed above, we 

propose to reorganize and revise 42 CFR 

part 486, subpart G. Following is a 

discussion of the specific requirements 

contained in the proposed conditions. 

Proposed General Requirements 

Basis and Scope (Proposed § 486.301) 

Section 486.301 (Basis and scope) 

would remain unchanged from the 

existing regulations except that we 

would add a reference to § 1102 of the 

Act, and we would add the term, ‘‘nonrenewal’’ to § 486.301(b)(3) to clarify 

that the scope includes non-renewal of 

agreements. 

Definitions (Proposed § 486.302) 

To reflect organizational changes in 

the regulations text, to remove obsolete 

material, and to provide further clarity 

to the regulations, we propose several 

amendments and additions to the 

definitions. 

We propose amending the definition 

for ‘‘certification’’ to mean a Secretarial 

determination that an OPO meets (or 

has met) the requirements at 42 CFR 

486.303 and is eligible for designation if 

it meets the additional requirements for 

designation.

We propose amending the definition 

of ‘‘designation’’ to clarify that 

designation is the process of assigning 

geographic service areas to OPOs. Once 

an OPO is certified and assigned a 

6090 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

geographic service area, organ 

procurement costs of the OPO are 

eligible for Medicare and Medicaid 

payment under § 1138(b)(1)(F) of the 

Act. 

We propose amending the definition 

of ‘‘entire metropolitan statistical area’’

to state that we do not recognize 

consolidated metropolitan statistical 

areas (CMSAs) when making service 

area determinations. 

We propose amending the definition 

of ‘‘organ’’ to clarify that the definition 

includes multivisceral organs only 

when they are transplanted with an 

intestine. 

We propose eliminating ‘‘potential 

donor’’ and replacing it with ‘‘organ 

donor potential.’’ The definition of 

‘‘potential donor’’ in the current 

regulations refers to causes and 

conditions of death that are ‘‘generally 

acceptable’’ for donation of at least one 

solid organ.’’ In our definition for 

‘‘organ donor potential,’’ we would 

include specific parameters for the 

cause and conditions of death that 

indicate medical suitability for organ 

donation. These parameters are 

discussed in this preamble under 

‘‘Proposed OPO Outcome Measures,’’

section C3. We are particularly 

interested in public comments on this 

proposed definition. 

We propose replacing ‘‘transplant 

center’’ with ‘‘transplant hospital’’ and 

have standardized the use of ‘‘transplant 

hospital’’ throughout this proposed 

regulation. A transplant hospital means 

a hospital that furnishes organ 

transplants and other medical and 

surgical specialty services required for 

the care of transplant patients. There 

may be one or more types of organ 

transplant centers operating within the 

same transplant hospital. 

Additionally, we propose adding 

definitions for ‘‘adverse event,’’

‘‘agreement cycle,’’ ‘‘death record 

review,’’ ‘‘de-certification,’’ ‘‘designated 

requestor,’’ ‘‘donor,’’ ‘‘donor 

document,’’ ‘‘potential donor 

denominator,’’ and ‘‘re-certification 

cycle.’’

We propose a definition for ‘‘adverse 

event’’ because we propose requiring an 

OPO to report those events to us so that 

we can monitor the OPO’s response to 

the adverse event. An adverse event 

would mean an untoward, undesirable, 

and usually unanticipated event that 

causes death or serious injury or the risk 

thereof. 

We propose definitions for 

‘‘agreement cycle’’ and ‘‘re-certification 

cycle’’ to clarify the difference between 

the two. The 4-year CMS/OPO 

agreement cycle runs from August 1 

through July 31, unless it is extended 

according to § 486.314. The 4-year recertification cycle is based on the 

calendar year. 

We have included a proposed 

definition for ‘‘death record review’’

because we would require OPOs to 

perform death record reviews as part of 

their QAPI programs. 

We have included a definition for 

‘‘de-certification’’ to explain that decertification follows our determination 

that an OPO no longer meets one or 

more conditions for coverage (including, 

the outcome measures at § 486.318 and 

the process performance measures and 

other requirements) or no longer meets 

the requirements for certification or 

designation. If an OPO’s agreement with 

us is terminated or is not renewed, the 

OPO is de-certified. 

We propose adding a definition for 

‘‘designated requestor’’ to explain the 

role of designated requestors in the 

donation process. We propose a 

definition for ‘‘donor’’ to ensure that 

OPOs’’ reporting of donor data is 

standardized. (The definition of 

‘‘donor’’ is not intended to limit 

acceptable donors.)

We are proposing a definition for 

‘‘donor document’’ because we would 

require OPOs to ensure that, in the 

absence of a donor document, the 

individual or individuals with 

responsibility to make the donation 

decision are informed of their option to 

donate organs or tissues or to decline to 

donate. 

We propose adding ‘‘potential donor 

denominator’’ to the definitions because 

we would use this term for the potential 

donor data OPOs would report to the 

OPTN. Those data would be used as the 

basis for the multiple outcome 

measures. 

These definitions, as we propose to 

add or revise them, are contained in the 

regulatory text section at the end of this 

document. 

Requirements for Certification and 

Designation 

[If you choose to comment on this 

section, please include the caption 

‘‘Certification and Designation 

Requirements’’ at the beginning of your 

comments.] 

Requirements for Certification 

(Proposed § 486.303) 

The current regulations do not make 

a clear distinction between the 

requirements necessary for certification 

and the requirements necessary for 

designation, nor do they specify that an 

OPO must be certified before it is 

designated for a service area. Therefore, 

we propose adding a new section to 

specify the requirements an OPO must 

meet to be certified. 

Following are the proposed 

requirements. After each proposed 

requirement, we have listed the location 

of the requirement in the statute or in 

current regulations. To be certified, an 

OPO must: 

(1) Have received a grant under 42 

U.S.C. 273(a). 

(2) Be a non-profit entity that is 

exempt from Federal income taxation 

under § 501 of the Internal Revenue 

Code of 1986. (See § 486.306(a).) 

(3) Have accounting and other fiscal 

procedures necessary to assure the fiscal 

stability of the organization, including 

procedures to obtain payment for 

kidneys and non-renal organs provided 

to transplant hospitals. (See 

§ 486.306(b).) 

(4) Have an agreement with the 

Secretary to be reimbursed under title 

XVIII for the procurement of kidneys. 

(See section 371(b)(1)(C) of the PHS 

Act.) 

(5) Have been re-certified as an OPO 

under the Medicare program from 

January 1, 2002 through December 31, 

2005. (See § 486.301(b)(4).) 

(6) Have procedures to obtain 

payment for non-renal organs provided 

to transplant centers. (See 

§ 273(b)(1)(E).) 

(7) Agree to enter into an agreement 

with any hospital in the OPO’s service 

area, including a transplant hospital, 

that requests an agreement. (See 

486.304(b)(8).) 

(8) Meet or have met the conditions 

for coverage, including the outcome 

measures and the process performance 

measures and other requirements. (See 

§ 486.314. This section states that an 

OPO’s agreement with CMS may be 

terminated if the OPO does not meet the 

two conditions for coverage in the 

current regulations, as well as the 

requirements for qualifications for 

designation found in § 486.306.) 

We propose that these threshold 

requirements for certification must be 

met before an OPO can be designated, 

pursuant to our proposed § 486.304. 

Requirements for Designation (Proposed 

§ 486.304) 

Provisions regarding general 

requirements for designation as an OPO 

currently found in § 486.304 (‘‘General 

requirements’’) and requirements at 

§ 486.306 (‘‘Qualifications for 

designation as an OPO’’) would be 

reorganized. Some requirements found 

in current § 486.304 have been moved to 

proposed § 486.303. Other requirements 

judged to be burdensome or 

unnecessary have been removed. For 

example, we would no longer require 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6091

OPOs to submit a written application for 

designation. 

Most requirements in the current 

§ 486.306 would be incorporated into 

other sections of the proposed rule. 

Specifically, requirements for OPO 

advisory boards and boards of directors 

have been moved to proposed § 486.324 

(‘‘Administration and governing body’’). 

Requirements for agreements with 

hospitals, critical access hospitals, and 

tissue banks can be found in proposed 

§ 486.322 (Relationships with hospitals, 

critical access hospitals, and tissue 

banks). Requirements for testing of 

donors and organs can be found in both 

proposed § 486.344 (Donor evaluation 

and management and organ placement 

and recovery) and proposed § 486.346 

(Organ preparation and transport). 

Requirements for data reporting have 

been moved to proposed § 486.328 

(Reporting of data), and requirements 

for protecting privacy of data can be 

found in proposed § 486.330 

(Information management). Finally, 

requirements for professional education 

can be found in § 486.326 (Human 

resources). Our rationale for these 

proposed changes is addressed later in 

this preamble in our discussion of the 

individual sections. 

In addition, we propose requiring 

OPOs to file a cost report within 5 

months following the end of the fiscal 

year, rather than the current 3 months. 

This would conform the OPO 

regulations to § 413.24(f).

OPO Service Area Size Designation and 

Documentation Requirements (Proposed 

§ 486.306) 

The requirements contained in this 

section would be re-designated from the 

current § 486.307, and many 

requirements would remain unchanged. 

We would no longer require OPOs to 

provide population data to us since 

population would no longer be used as 

a basis for OPO certification. 

We propose retaining the requirement 

that an OPO must procure organs from 

an average of at least 24 donors per 

calendar year. We believe it is important 

to retain this requirement to assure that 

each OPO has ‘‘a defined service area of 

sufficient size to assure maximum 

effectiveness in the procurement and 

equitable distribution of organs* * *’’

as Congress intended. (See section 

371(b)(1)(F) of the PHS Act.) In 

addition, we would change the current 

requirement for an average of 24 donors 

per calendar year in the 2 years before 

the year of re-designation to a 

requirement for an average of 24 donors 

per calendar year in the 4 years before 

the year of re-designation because the 

re-certification cycle has been increased 

from 2 years to 4 years. 

However, we would no longer permit 

exceptions to the 24-donor per year rule, 

including the exception for an OPO that 

serves an entire state. (See 

§ 486.307(d)(2)(ii).) When the current 

regulations were published in 1996, the 

average OPO recovered 77 donors per 

year. Because of a decrease in the 

number of OPOs and an increase in the 

number of donors recovered 

nationwide, the average OPO procured 

approximately 100 donors in 2002. 

Therefore, we believe that an OPO 

procuring fewer than 96 donors in a 4-

year period is too small to operate 

efficiently and effectively. 

We propose removing language from 

the current regulations that refers to 

new entities or organizations becoming 

OPOs. Section 371(a) of the PHS Act 

provides authority for the Secretary to 

make grants to qualified OPOs that are 

described in subsection (b). However, 

given the provision in (b)(1)(D) added 

by the OPO Certification Act of 2000 

(‘‘notwithstanding any other provision 

of law, has met the requirements of this 

section and has been certified or recertified by the Secretary within the 

previous 4-year period as meeting the 

performance standards to be a qualified 

organ procurement organization* * *’’), 

it appears impossible for the Secretary 

to give a grant to an organization that 

was not one of the 59 OPOs that was 

certified by the Secretary as meeting the 

performance standards in the 4-year 

period before January 1, 2000. 

Therefore, we propose removing the 

language at § 486.307(d)(2)(iv) that 

requires an entity to show that it can 

procure organs from at least 50 potential 

donors per year if it was not previously 

designated as an OPO. We also propose 

removing references related to 

designation of or requirements for 

entities or organizations that are not 

currently OPOs 

Additionally, we would remove 

obsolete service area size standards for 

periods during 1996 and before. We 

would change the current requirement 

for submission of information about 

acute care hospitals that have an 

operating room and the equipment and 

personnel to retrieve organs to 

submission of information about 

hospitals that have both a ventilator and 

an operating room, since we propose 

requiring OPOs to have agreements with 

95 percent of those hospitals. (See 

discussion in this preamble of 

§ 486.322, Relationships with hospitals, 

critical access hospitals, and tissue 

banks). Finally, we would increase the 

designation period from 2 years to 4 

years to conform the designation period 

to the re-certification cycle. 

Designation of One OPO for Each 

Service Area (Proposed § 486.308) 

Requirements for the designation of 

one OPO for each service area would be 

moved from § 486.316 to proposed 

§ 486.308. Many requirements would 

remain unchanged. However, we 

propose replacing the ‘‘tie-breaker 

criteria’’ used to designate an OPO 

when two or more OPOs apply for the 

same area with new criteria found in 

proposed § 486.316 (‘‘Re-certification 

and competition processes’’). (See 

discussion of proposed § 486.316 in this 

preamble for a discussion of the 

proposed criteria.) 

Changes in Ownership or Service Area 

(Proposed § 486.310) 

The requirements for an OPO 

changing ownership or changing its 

service area found in § 486.318 would 

be moved to proposed § 486.310. Many 

requirements would remain unchanged. 

However, we propose requiring certain 

additional information if there is a 

change in ownership of an OPO. The 

OPO would be required to provide 

information specific to the board 

structure of the new organization to 

ensure that all required representatives 

are included. In addition, the OPO 

would be required to submit operating 

budgets, financial information, and 

other written documentation we 

determine to be necessary for 

designation to ensure that the OPO 

continues to meet the requirements for 

designation. 

De-Certification (Proposed § 486.312) 

[If you choose to comment on this 

section, please include the caption ‘‘Decertification’’ at the beginning of your 

comments.]

Many of the requirements contained 

in § 486.325 (‘‘Termination of agreement 

with CMS’’) would be moved to 

proposed § 486.312, but the title of the 

section would be changed to ‘‘Decertification,’’ to reflect the fact that if 

an OPO’s agreement with us ends 

(whether through voluntary or 

involuntary termination or non-renewal 

of the OPO’s agreement), we would decertify the OPO. 

The paragraph titled ‘‘Voluntary 

termination’’ would remain 

substantially unchanged, but the 

paragraph would be renamed ‘‘Decertification due to voluntary 

termination of agreement.’’

Additionally, we would add language to 

indicate that we would de-certify the 

OPO as of the effective date of the 

voluntary termination. The paragraph 

6092 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

titled ‘‘Involuntary termination’’ also 

would remain substantially unchanged, 

but the paragraph would be renamed 

‘‘De-certification due to involuntary 

termination of agreement.’’

Additionally, we propose adding 

language to indicate that we would decertify the OPO as of the effective date 

of the involuntary termination. 

We propose adding a paragraph titled, 

‘‘De-certification due to non-renewal of 

agreement,’’ which states that we will 

not renew an OPO’s agreement if the 

OPO fails to meet the outcome measures 

at § 486.318 based on data from the most 

recent re-certification cycle or if the 

OPO is no longer designated for the 

service area. In that case, we would decertify the OPO as of the ending date of 

the agreement. We propose removing 

the paragraph titled, ‘‘Appeal right,’’

because we propose a new appeals 

process in § 486.314. 

In proposed § 486.312(d), we have 

retained our general policy of providing 

an OPO with at least 90 days notice 

before a de-certification would be 

effective. However, we propose that in 

cases of urgent need, notice of decertification would be given at least 

three days before de-certification. We 

expect that cases where an OPO would 

need to be replaced based on urgent 

need would be extremely rare. 

Nevertheless, in unusual circumstances, 

this expedited time frame may be 

necessary to protect the public health. 

The notice to the OPO would 

specifically state the reason for decertification and the effective date. We 

propose changing the title of the 

paragraph, ‘‘Effects of termination’’ to 

‘‘Effects of de-certification.’’ We propose 

retaining the paragraph, ‘‘Public 

Notice,’’ but we would add language 

that states we would give public notice 

of involuntary termination or nonrenewal of agreement in local 

newspapers in the OPO’s service area.

Finally, we propose eliminating the 

paragraph, ‘‘Reinstatement’’ because our 

proposed appeals process sets forth the 

process we would use for an OPO 

whose de-certification was reversed by 

a CMS hearing officer. If a hearing 

officer upheld a de-certification, we 

would not voluntarily reinstate the decertified OPO. Thus the current 

language regarding reinstatement would 

no longer be needed. 

Appeals (Proposed § 486.314) 

[If you choose to comment on this 

section, please include the caption 

‘‘Appeals’’ at the beginning of your 

comments.] 

Under existing regulations, an 

agreement with an OPO could be 

involuntarily terminated for failure to 

meet the conditions for coverage, and 

any resulting appeals were governed by 

regulations at 42 CFR part 498. If an 

OPO failed the outcome performance 

standards set forth in 486.310, we decertified the OPO as of August 1 of the 

year following the end of the recertification cycle. Although the OPO 

was given the right to appeal under part 

498, it was not possible to complete the 

appeals process prior to expiration of 

our agreement with the OPO on August 

1. Therefore, we opened the OPO’s 

service area to competition from other 

OPOs as soon as the OPO was notified 

about the de-certification. The existing 

time frame generally did not permit a 

decision to be made on an appeal prior 

to a successor OPO taking over the 

service area when the de-certified OPO’s 

agreement with us expired on August 1. 

In order to resolve this problem, we 

propose to make changes to the appeals 

process and alter the timing of the 

competition. Specifically, we would: (1) 

Delay competition until an appeal is 

completed; (2) expedite appeals by 

using a CMS hearing officer; and (3) 

extend an OPO’s agreement beyond 

August 1 if necessary. 

In the OPO Certification Act of 2000, 

Congress specified that we must 

propose a process whereby an OPO 

could appeal a de-certification on 

substantive or procedural grounds. (See 

section 273(b)(D)(ii)(IV).) Therefore, we 

are proposing a process whereby an 

OPO facing de-certification due to 

involuntary termination or non-renewal 

of its agreement with us would be able 

to appeal the de-certification on 

substantive or procedural grounds and 

receive a decision on its appeal before 

its service area was opened for 

competition from other OPOs. We 

believe the proposed appeals process 

would be both fair and expeditious. 

An OPO would have 30 calendar days 

from the date on the notice of decertification to submit an appeal to a 

CMS hearing officer. In the appeal, the 

OPO would be given the opportunity to 

submit evidence to show why it should 

not be decertified. Appeals could be 

based on substantive and/or procedural 

grounds. Within 2 weeks of receipt of 

the OPO’s appeal, the CMS hearing 

officer would schedule a hearing. The 

hearing officer would issue notice of his 

or her decision to the OPO by certified 

mail within 2 weeks following the date 

of the hearing. 

In making an appeal on substantive 

grounds, an OPO could submit evidence 

of factors that negatively impacted organ 

donation in its service area and 

prevented it from meeting the outcome 

or process performance measures or 

other requirements. For example, an 

OPO might have evidence that its ability 

to obtain consent from families of 

potential donors was adversely affected 

by certain demographic factors in its 

service area, such as the presence of a 

significant number of citizens whose 

race, ethnicity, religion, or educational 

level may be associated with lower rates 

of consent to organ donation. As another 

example, an OPO might have evidence 

that its ability to recover and transport 

organs to transplant centers while they 

are still viable for transplantation was 

hampered by the remote location of 

many of its donor hospitals. 

Since most OPOs have some factors in 

their service areas that work against 

organ donation, the failing OPO would 

need to demonstrate not only the 

specific factors that affected its ability to 

meet the outcome measures but also 

what it did to attempt to ameliorate the 

factors. For example, if an OPO 

provided data to show that it has a high 

minority population that historically 

has had a lower rate of consent to 

donation, the OPO would have to 

demonstrate what it did to address the 

situation (such as conducting targeted 

public education) and whether these 

efforts were successful. 

Evidence submitted by an OPO about 

substantive factors could include, but 

would not be limited to, research 

studies, demographic studies, data from 

the OPO’s QAPI program, and 

information on the OPO’s public and 

professional education and hospital 

development activities. 

In making an appeal on procedural 

grounds, an OPO could, for example, 

provide evidence that incorrect data 

were used by us to determine whether 

the OPO met the outcome measures. 

We propose that if the hearing officer 

reversed our determination to de-certify 

an OPO in a case involving the 

involuntary termination of the OPO’s 

agreement, we would not de-certify the 

OPO. An OPO that was successful in its 

appeal would have a right to compete 

for this service area for the next cycle.

If the de-certification determination 

was upheld by the hearing officer, 

Medicare and Medicaid payment would 

not be made for organ procurement 

services the OPO furnished on or after 

the effective date of de-certification. The 

unsuccessful OPO would not be 

permitted to compete for the service 

area, or any other service area. 

As stated earlier, OPOs currently have 

the right to appeal a de-certification 

under part 498, which sets forth 

procedures for providers and suppliers 

to appeal decisions that affect 

participation in the Medicare program. 

Since this proposed rule includes an 

appeals process for OPOs that is 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6093

separate from the part 498 process, we 

propose that if a hearings officer denied 

an OPO’s appeal, the OPO would have 

no further administrative appeal rights. 

Thus, we propose removing OPOs from 

the definition of suppliers found at 

§ 498.2. 

However, we note that section 901 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act 

(MMA) defines the term ‘‘supplier’’ to 

mean ‘‘unless the context otherwise 

requires, a physician or other 

practitioner, a facility, or other entity 

(other than a provider of services) that 

furnishes items or services under this 

title [title XVIII].’’ Nevertheless, the 

unique nature of OPOs and their special 

role in the Medicare program 

distinguishes them from other suppliers. 

Typically, suppliers furnish medical 

items and services directly to Medicare 

beneficiaries and obtain direct payment 

for Medicare-covered items and services 

from a Medicare carrier. A supplier may 

furnish one or more of the health care 

items included within the definition of 

‘‘medical and other health services’’ that 

are defined in section 1861(s) of the Act 

and are included in the scope of the part 

B program. (See section 1832 of the 

Act.) Many suppliers do not have a 

formal participation agreement with the 

Secretary. (See section 1842(h) of the 

Act.) In contrast, an OPO is required to 

have an agreement with the Secretary. 

(See 42 U.S.C 273(b)(1)(C).) Moreover, 

many, if not most, organ donors are not 

Medicare beneficiaries, and many 

organs recovered by OPOs are not 

transplanted into Medicare 

beneficiaries. 

Given this framework, and to ensure 

that Medicare pays appropriately for its 

share of organ acquisition costs, OPOs 

have payment rules and methodologies 

that differ from the payment rules and 

methodologies used for other suppliers. 

(See, for example, 42 CFR § 413.200.) 

Among other differences, organ 

acquisition costs are not paid directly by 

a carrier to an OPO. Instead, the OPO is 

paid by the transplant hospital, subject 

to later adjustment (see 42 CFR 

413.200(c)(iv)), and Medicare pays the 

transplant hospital for the organ 

acquisition costs. If necessary, Medicare 

payment to the OPO is adjusted after it 

files its yearly cost report; for example, 

if the OPO’s costs to recover organs 

exceeded the payments it received for 

the organs, Medicare covers the 

additional costs, based on the 

percentage of organs that were 

recovered and transplanted into 

Medicare beneficiaries. However, for 

purposes of the adjustment, all organs 

provided by the OPO to Medicareapproved transplant centers are 

considered to be organs that were 

transplanted into Medicare 

beneficiaries. Since approximately 64 

percent to 74 percent of extra-renal 

organ transplant centers and 

approximately 100 percent of kidney 

transplant centers are Medicare 

approved, the Medicare program 

reimburses OPOs for their excess costs 

for most of the organs they recover. 

Thus, the legal relationship between an 

OPO and the Medicare program is 

different from other ‘‘suppliers’’ and 

reflects important statutory differences.

The MMA also requires the Secretary 

to establish in regulations a provider 

and supplier enrollment process that 

includes an appeals process. Section 

936 of MMA states that suppliers 

‘‘whose application to enroll (or, if 

applicable, to renew enrollment) under 

this title is denied may have a hearing 

and judicial review of such denial under 

the procedures that apply under 

subsection [1866](h)(1)(A) to a provider 

of services that is dissatisfied with a 

determination by the Secretary. 

Although the appeals process we 

propose for OPOs differs from the MMA 

appeals process, it specifically 

addresses the congressional findings 

associated with the OPO Certification 

Act of 2000 that the uncertainty of the 

current re-certification interferes with 

the effectiveness of OPOs in raising the 

level of donation. This alternative 

appeals process is necessary because 

there is a limited time period from the 

date that the outcome performance 

measure data are available to the date 

when the OPO contract cycle ends. 

Therefore, to achieve the goals of the 

2000 legislation, including providing an 

equitable process for appeals, OPO 

appeals must be expedited and 

completed before a replacement OPO is 

named in order to avoid disruption in 

organ procurement. 

Under our proposed rule, if the 

hearing officer upheld a de-certification 

determination, we would open the 

OPO’s service area for competition from 

other OPOs. The de-certified OPO 

would not be permitted to compete for 

the open area, and in most cases, the decertification would be effective as of the 

ending date of the OPO’s agreement 

with us. 

However, if the appeals process did 

not leave sufficient time for us to 

conduct a competition process for the 

open area and provide for a smooth 

transition of the service area to the 

successor OPO, we could, at our 

discretion, extend the OPO’s agreement 

with us for a period of time not to 

exceed an additional 60 days. 

We believe the appeals process we 

propose fully satisfies the statutory 

requirement to provide a process for an 

OPO to appeal a de-certification on 

substantive and procedural grounds. 

Although the process is streamlined to 

allow an OPO to receive a decision on 

its appeal before the effective date of the 

de-certification and before its service 

area being opened for competition, it 

allows ample time for the OPO to 

prepare and present evidence of the 

substantive or procedural basis for its 

appeal. Furthermore, the process allows 

sufficient time for a hearing officer to 

consider the evidence and make a fair 

decision that affords all of the process 

that is due to the OPO, while 

safeguarding our ability to remove and 

replace an OPO that has not performed 

well.

Re-Certification and Competition 

Processes (Proposed § 486.316) 

[If you choose to comment on this 

section, please include the caption ‘‘Recertification and competition’’ at the 

beginning of your comments.] 

Congress stated in the congressional 

findings associated with section 219 of 

the Consolidated Appropriations Act, 

2001 that the OPO re-certification 

process ‘‘created a level of uncertainty 

that is interfering with the effectiveness 

of organ procurement organizations in 

raising the level of donation.’’ Under 

existing regulations at § 486.310 and 

§ 486.316, the service area of every OPO 

was opened for competition at the 

conclusion of every re-certification 

cycle, regardless of whether the OPO 

met the outcome performance standards 

for the prior re-certification cycle. Any 

OPO that met the performance 

standards for the prior re-certification 

cycle was eligible to compete for an 

open service area or a portion of an 

open service area. 

Under existing OPO regulations, an 

OPO that failed to meet the outcome 

measures would lose its service area and 

be de-certified. Its service area would be 

opened for competition from all OPOs 

that met the outcome performance 

standards. If no OPO that met the 

outcome performance standards was 

willing to accept responsibility for the 

service area, the OPO that failed the 

outcome performance measures would 

be re-designated for the service area if 

it submitted an acceptable corrective 

action plan to us. 

Under existing regulations, if more 

than one OPO that met the performance 

standards wanted to take over the 

service area or part of the service area 

of another OPO, we used six 

‘‘tiebreaker’’ criteria to determine which 

OPO should be awarded the service 

area. The tiebreakers were: (1) Prior 

performance, including the previous 

6094 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

year’s experience in terms of the 

number of organs retrieved and wasted 

and the average cost per organ; (2) 

actual number of donors compared to 

the number of potential donors; (3) the 

nature of relationships and degree of 

involvement with hospitals in the 

organization’s service area; (4) bed 

capacity associated with the hospitals 

with which the organizations have a 

working relationship; (5) willingness 

and ability to place organs within the 

service area; and (6) proximity of the 

organization to the donor hospitals. 

As stated earlier in this preamble, we 

propose opening every OPO’s service 

area for competition at the end of every 

re-certification cycle as we did under 

the existing regulations. However, we 

are proposing certain limitations that we 

believe would address the uncertainty 

in the re-certification process that was 

noted by Congress. The limitations 

would ensure that: (1) The process can 

be completed expeditiously; (2) 

disruptions to service areas will be 

minimized; and (3) an OPO may 

compete for an open area only if it is 

likely to be able to improve organ 

donation in the service area. 

The proposed competition process 

would differ somewhat, depending 

upon whether a service area was opened 

for competition because the incumbent 

OPO was de-certified or because of the 

wider competition process taking place 

at the end of a re-certification cycle. 

First, we would permit OPOs to 

compete for open areas only if they met 

certain specific objective criteria. These 

criteria would vary, depending upon 

whether the incumbent OPO was or was 

not de-certified. Second, we would 

allow competition only for entire 

service areas. A service area could be 

divided only if the incumbent OPO was 

de-certified and no OPO wanted to 

accept responsibility for the service 

area. In such case, we could, at our 

discretion, choose a single OPO to take 

over the service area or adjust the 

service area boundaries of two 

contiguous OPOs to incorporate the 

open area. Finally, we are proposing to 

use specific clear, objective criteria for 

determining which OPO would be 

selected for a service area. 

The chart below shows how the 

process would differ. Following the 

chart is a more detailed explanation of 

our proposal.

Incumbent OPO

decertified? 

Incumbent OPO 

permitted to compete? 

Can service area 

be divided? 

Criteria OPOs must meet to compete 

for open area Criteria CMS uses to choose OPO 

Yes ......................... No ......................... Yes, at discretion 

of CMS.

4 out of 5 outcome performance 

measures at or above the mean.

Acceptable plan to increase organ donation in open area. 

No .......................... Yes ....................... No ......................... 4 out of 5 outcome performance 

measures at or above the mean. 

Conversion rate (actual donors as a 

percentage of potential donors) at 

least 15 percentage points higher 

than incumbent’s conversion rate.

Acceptable plan to increase organ donation in open area. 

Competition When OPO Has Been DeCertified 

We propose that if we notify an OPO 

that it will be de-certified because its 

agreement will be terminated or will not 

be renewed and the OPO does not 

appeal within the time frame specified 

in § 486.314(a) or the OPO appeals but 

the de-certification is upheld (see 

§ 486.314(c)), we would open the OPO’s 

service area for competition from other 

OPOs. An OPO’s service area would not 

be opened for competition until the 

conclusion of the proposed appeals 

process. 

Only OPOs that meet 4 out of 5 

outcome performance measures at or 

above the mean for the preceding recertification cycle would be eligible to 

compete for the open service area of a 

de-certified OPO. The de-certified OPO 

would not be permitted to compete for 

its service area, or any other service 

area. Competing OPOs would be 

permitted to compete only for the entire 

service area. 

By requiring an OPO to have attained 

the mean or greater in 4 out of the 5 

outcome performance measures in order 

to compete for the open area of a decertified OPO, we would limit 

competition to OPOs that have 

performed significantly better than the 

failing OPO. That is, the overall 

performance of an OPO that meets 4 out 

of 5 outcome performance measures at 

or above the mean would be, at the 

least, approximately 25 percentage 

points higher overall than the 

performance of an OPO that is decertified because it did not meet 4 out 

of 5 outcome performance measures at 

75 percent of the mean. We propose 

establishing the threshold at 100 percent 

of the mean for 4 out of 5 outcome 

performance measures because we 

believe that an OPO whose performance 

is at or above the mean would have the 

expertise needed to take over a failing 

OPO’s service area and improve organ 

donation. 

OPOs would be permitted to compete 

only for entire service areas. We have 

found that permitting competition for 

partial service areas provides an 

incentive for OPOs to attempt to ‘‘raid’’ 

portions of neighboring service areas for 

purely business reasons, with no regard 

to whether the OPO can increase organ 

donation in those areas. For example, 

an OPO may wish to take over counties 

in a neighboring service area where 

hospitals demonstrate high conversion 

rates, which would improve the 

competing OPO’s overall outcome 

performance measures but lead to no 

actual increase in organ donation. An 

OPO with a tissue bank may want a 

section of another OPO’s service area 

that has particularly high tissue 

donation potential in hopes of 

expanding its tissue bank into the area. 

Because of the problems created by 

allowing competition for partial service 

areas, we believe it is critically 

important to require OPOs to compete 

for entire service areas.

If no OPO applied to compete for the 

service area of a de-certified OPO, we 

could select a single OPO to take over 

the entire open area or adjust the service 

area boundaries of two or more 

contiguous OPOs to incorporate the 

open area. CMS would select an OPO 

based on the OPO’s success in meeting 

the process performance standards 

during the preceding re-certification 

cycle 

Competition When OPO Has Not Been 

De-Certified

We propose that all OPO service areas 

would be opened for competition at the 

end of every re-certification cycle. Once 

we determined that an OPO met the 

outcome measures at § 486.318 for the 

previous re-certification cycle and was 

found to be in compliance with the 

process performance measures and 

other requirements at §§ 486.320 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6095

through 486.348, CMS would open the 

OPO’s service area for competition from 

other OPOs. 

To compete for open areas, OPOs 

would be required to meet certain 

criteria based on data from the 

preceding re-certification cycle. An OPO 

would be required to meet the 

following: (1) 4 out of 5 outcome 

performance measures at or above the 

mean; and (2) a conversion rate of 

potential donors to actual donors at 

least 15 percentage points higher than 

the conversion rate of the OPO currently 

designated for the service area. (The 

conversion rate is the first of the five 

outcome performance measures.) OPOs 

would be required to compete for an 

entire service area. The incumbent OPO 

would be permitted to compete for its 

own service area. 

To illustrate how this process would 

work, we provide the following 

example: 

OPO A’s service area is opened for 

competition. The OPO met 4 out of 5 

outcome performance measures at or 

above the mean for the preceding recertification cycle. Its conversion rate 

was 109 percent of the mean. A survey 

of the OPO determined that it met all 

process performance measures. Two 

OPOs would like to compete for OPO 

A’s service area. Both OPOs met 4 out 

of 5 outcome performance measures at 

or above the mean and both met all 

process performance measures. OPO B’s 

conversion rate was 117 percent of the 

mean, and OPO C’s conversion rate was 

125 percent of the mean. OPO C is 

permitted to compete for OPO A’s open 

area because its conversion rate is 16 

percentage points higher than OPO A’s 

conversion rate. OPO B is not permitted 

to compete for the open service area 

because its conversion rate is only 8 

percentage points higher than OPO A’s 

conversion rate. In selecting an OPO for 

the service area, we would consider 

each OPO’s success in meeting the 

process performance measures during 

the prior re-certification cycle, as well 

as submission of an acceptable plan to 

increase organ donation in the open 

service area. 

We propose that an acceptable plan 

would, at a minimum: (1) Be based on 

the competing OPO’s experience in its 

own service area; (2) include an analysis 

of existing barriers to increasing organ 

donation in the open area, both internal 

(for example, high staff turnover) and 

external (for example, language barriers 

due to a high number of recent 

immigrants in the OPO’s service area); 

and (3) provide a detailed description of 

specific activities and interventions for 

increasing organ donation in the open 

area. An OPO’s plan to increase organ 

donation in the open service area would 

be used by us to assist in identifying the 

most effective organization to maximize 

organ donation in the open area. 

Given the constraints imposed by 

geography, as well as the variation in 

OPO performance, resources, and 

ability, we believe the process we 

propose would result in the selection of 

the OPO or OPOs most likely to improve 

organ donation rates in an open area. 

As stated earlier in this preamble, we 

expect that our proposal would permit 

the competition process to be completed 

expeditiously. Agreements expire on 

July 31 of the year following the end of 

the re-certification cycle (for example, 

the current re-certification cycle ends 

December 31, 2005, and our agreements 

with OPOs expire July 31, 2006), giving 

us only 7 months to complete the many 

steps necessary to re-certify OPOs and 

renew their agreements with CMS. To 

reduce the uncertainty in the recertification process identified by 

Congress, it is important that the 

competition process be completed as 

quickly as possible so that OPOs know 

whether they will retain their service 

areas for an additional 4 years.

We expect that the OPTN and SRTR 

will need a minimum of 2 months to 

finalize the OPO outcome performance 

measure data after the close of a recertification cycle on December 31. This 

would leave at most 5 months for us to 

analyze the data, determine whether 

each OPO met or did not meet the 

requirements for re-certification, notify 

OPOs of their status, open service areas 

for competition, provide sufficient 

opportunity for OPOs competing for a 

service area (including the incumbent 

OPO) to develop and submit a plan to 

increase organ donation, review plans, 

designate an OPO for each service area 

that is under competition, notify OPOs 

of their status, and conduct transitional 

activities, as needed. 

We believe that our proposed process 

would facilitate the timely completion 

of the competition for three reasons: (1) 

The process we propose is simple and 

straightforward; (2) the requirements we 

propose for OPOs to compete for an 

open area are unambiguous and, 

therefore, unlikely to lead to 

misunderstandings that could impede 

the process; and (3) the requirements for 

competition, as well as the prohibition 

against dividing service areas, would act 

to limit the number of OPOs permitted 

to or interested in competing for open 

areas. 

We propose opening all OPO service 

areas at the end of every re-certification 

cycle because we believe that healthy 

competition between OPOs can lead to 

improvements in quality and outcomes, 

as long as there are strict criteria for 

selecting the OPOs that are permitted to 

compete for open areas.

We have found that completely 

unrestrained competition for OPO 

service areas can damage collaborative 

relationships, impede sharing of best 

practices across OPOs, and, as a result, 

degrade OPO quality. As a consequence 

of the Breakthrough Collaborative, 

OPOs have forged an impressive 

number of collaborative relationships. 

OPOs are eagerly sharing best practices 

and providing assistance to fellow OPOs 

in solving problems and reducing 

barriers to donation. For the first time, 

many OPOs are seeing themselves not 

just as individual businesses but as 

participants in a widespread campaign 

to save lives by increasing organ 

donation. We believe it is critical that 

the competition process we use to recertify OPOs does not damage these 

collaborative relationships. Therefore, 

we are requesting comments on the 

following competition options.

One option would be a highly 

restricted competition process in which 

only service areas of OPOs that did not 

meet the conditions for coverage (that is, 

the outcome performance measures at 

§ 486.318 or the process performance 

measures and other requirements at 

§§ 486.320 through 486.348) would be 

opened for competition. Any OPO that 

met the conditions for coverage would 

be re-certified, re-designated for its 

service area, and its agreement with 

CMS would be renewed for another 4 

years. This competition process would 

considerably reduce the uncertainty in 

the re-certification process that was 

identified by Congress. However, this 

process would nearly eliminate 

desirable competition that we believe 

can create an incentive for OPOs to 

perform optimally. 

We are soliciting comments on 

variations of the proposed limited 

competition process for OPOs whose 

service areas would be opened for 

competition at the end of a recertification cycle (with the exception of 

OPOs whose service areas would be 

opened due to de-certification). Under 

these options, all service areas would be 

opened for competition, but the criteria 

OPOs would be required to meet to 

compete for open areas would differ. 

Under alternative one, an OPO would be 

permitted to compete for an open area 

if its conversion rate was a least 15 

percentage points higher than the 

conversion rate of the OPO currently 

designated for the service area. This 

alternative would not require that an 

OPO meet a minimum outcome 

performance measure standard. It 

would allow more OPOs to compete for 

6096 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

open areas. However, this alternative 

would allow OPOs whose performance 

is below the mean to compete for open 

areas.

Alternative two is a limited 

competition process similar to the one 

we propose in this proposed rule, except 

that a competing OPO would be 

required to meet 120 percent of the 

mean, rather than 100 percent of the 

mean, for 4 out of 5 outcome 

performance measures. Under this 

alternative, an OPO still would be 

required to have a conversion rate at 

least 15 percentage points higher than 

the conversion rate of the OPO 

designated for the service area. It is 

likely that very few OPOs would be able 

to compete for open areas under this 

competition process, but the strict 

criteria would ensure that only the very 

best OPOs could compete for open 

areas.

We believe that the limited 

competition process we propose, if 

implemented, would encourage healthy 

competition that improves OPO quality 

and functioning and would lead to 

increased organ donation and 

transplantation. We are requesting 

comments on the proposed and 

alternative forms of competition in this 

proposed rule. Specifically, we are 

requesting comments regarding the 

effect of competition on increasing 

organ donation, especially in service 

areas of poorly-performing OPOs, and 

on the collaborative relationship among 

OPOs.

Proposed OPO Outcome Measures 

[If you choose to comment on this 

section, please include the caption 

‘‘Outcome Measures’’ at the beginning 

of your comments.] 

Condition: Outcome Measures 

(Proposed § 486.318) 

A. Current Outcome Performance 

Standards 

Currently, five quantitative 

performance standards are used in 

evaluating OPO performance: number of 

donors, kidneys procured, kidneys 

transplanted, extra-renal organs 

procured, and extra-renal organs 

transplanted. Each of these outcome 

performance standards is calculated per 

million population, and OPOs are 

ranked accordingly. An OPO must be at 

or above 75 percent of the national 

mean for at least 4 out of 5 performance 

standards in order to be re-certified.

Congress directed that our new 

regulations include multiple outcome 

measures that are based on empirical 

evidence, obtained through reasonable 

efforts, of organ donor potential and 

other related factors in each OPO’s 

service area. Many factors can affect the 

number of potential donors in a service 

area, such as a large elderly population, 

a low motor vehicle accident rate, or a 

high incidence of the Human 

Immunodeficiency Virus/Acquired 

Immune Deficiency Syndrome (HIV/

AIDS). These factors are likely to reduce 

the number of potential organ donors, 

whereas factors such as a high homicide 

rate or a high motor vehicle accident 

rate are likely to increase the number of 

potential donors. 

B. Evaluation of Alternative Methods for 

Determining Organ Donor Potential 

In a 1997 report, ‘‘Organ Procurement 

Organizations: Alternatives Being 

Developed to More Accurately Assess 

Performance,’’ the U.S. General 

Accounting Office (GAO) explored 

options for assessing OPO performance 

and recommended that CMS consider 

developing new outcome measures 

based on the number of potential donors 

in an OPO’s service area. The report 

discusses the feasibility of replacing 

population with: (1) The number of 

deaths in an OPO’s service area; (2) the 

number of deaths adjusted for age and 

cause of death; (3) an estimate of the 

number of potential donors in an OPO’s 

service area determined by statistical 

modeling; or (4) the number of potential 

donors determined by death record 

reviews. 

The GAO report noted that both the 

number of deaths and the number of 

deaths adjusted for age and cause of 

death are a better indicator of the 

number of potential donors than 

population because they eliminate a 

large portion of the population that an 

OPO cannot consider for organ 

donation. However, the GAO pointed 

out that there are significant drawbacks 

to using either deaths or deaths adjusted 

for age and cause of death, including 

lack of timely data and the inability to 

identify those deaths suitable for use in 

organ donation. For example, although 

the National Center for Health Statistics 

(NCHS) collects death data from States, 

Oklahoma, and Puerto Rico do not 

report their deaths, and there is an 18 

to 24 month lag in the availability of 

death data from the NCHS. 

The GAO recommended that CMS 

investigate the development of two 

different models for estimating the 

number of potential donors in an OPO 

service area. One of these models was 

developed by the Harvard School of 

Public Health and the Partnership for 

Organ Donation, and the other was 

developed under the auspices of the 

AOPO. Although death record reviews 

are acknowledged to be the ‘‘gold 

standard’’ for estimating the number of 

potential organ donors (as long as they 

are conducted with a standardized 

protocol by uniformly trained 

reviewers), they are, as the GAO noted, 

relatively labor intensive, time 

consuming, and expensive. Therefore, 

CMS concurred with GAO’s 

recommendation to investigate 

alternatives for determining donor 

potential. 

1. Regression Models for Estimating 

Donor Potential 

Harvard and the Partnership for Organ 

Donation developed their model based 

on their 1993 study of 89 hospitals in 

3 OPO service areas, using regression 

analysis to test hospital characteristics 

as predictors of the number of potential 

organ donors. Their analysis 

demonstrated that four hospital 

characteristics used together could be 

used to predict organ donation 

potential: Number of staffed beds, 

trauma center certification, medical 

school affiliation, and Medicare casemix index (a measure of the complexity 

of cases treated in the hospital). The 

model was validated using death record 

reviews, and a study was conducted to 

verify the accuracy of the death record 

reviews (an interrator reliability study). 

The results of the study were published 

in the ‘‘American Journal of Public 

Health’’ in November 1998. (C 

Christiansen, S Gortmaker, J William, et 

al.: A Method for Estimating Solid 

Organ Donor Potential by Organ 

Procurement Region, American Journal 

of Public Health, Vol. 88, No. 22, 

November, 1998.)

Like the Harvard/Partnership model, 

the AOPO model was developed using 

regression analysis to test the validity of 

various hospital characteristics as 

predictors of donor potential. The 

AOPO model estimates the number of 

potential donors based on three factors: 

Whether the hospital has neurosurgery 

services; whether it has an emergency 

room; and whether it is a non-profit or 

for-profit entity. AOPO developed its 

model based on death record reviews in 

hospitals in 16 OPO service areas. (The 

study began with 30 OPOs, but 14 

furnished incomplete data and their 

data were not included in many of the 

analyses AOPO used to develop its 

model.) An interrator reliability study to 

determine the accuracy of the OPOs’

death record reviews has not been 

conducted. 

In 1999, we contracted with the 

Harvard School of Public Health to 

apply the Harvard/Partnership model in 

all OPOs nationwide. In 2000, after 

receiving Harvard’s results, we 

compared the number of potential 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6097

donors estimated by the Harvard model 

with the number of potential donors 

estimated by the AOPO model. (Both 

Harvard and AOPO used 1998 data.) We 

also compared the number of potential 

donors estimated by the two models in 

the 16 OPOs included in the AOPO 

study with the results from reviews of 

1998 death records in those 16 OPOs’

service areas conducted as part of the 

AOPO study. (Although AOPO has not 

conducted an interrator reliability study 

to verify the accuracy of the death 

record reviews, for purposes of this 

analysis, we assumed AOPO’s death 

record reviews accurately estimated the 

number of potential donors in each 

OPO’s service area during 1998.) 

When compared to the number of 

potential donors determined by AOPO 

through death record reviews, neither 

the Harvard model nor the AOPO model 

consistently predicted the number of 

potential donors in individual OPO 

service areas. In AOPO’s study of 16 

OPOs, estimates ranged from 18.6 

percent lower than the number of 

potential donors determined by death 

record reviews to an estimate that was 

47.7 percent higher than the number of 

potential donors determined by death 

record reviews. The Harvard model’s 

estimates ranged from 14.3 percent 

lower to 184 percent higher. 

The failure of the two models to 

accurately estimate the number of 

potential donors may be due to many 

factors, including the accuracy (or 

inaccuracy) of information about 

hospital characteristics obtained by the 

researchers from a variety of sources, 

such as interviews with hospital staffs 

and American Hospital Association 

(AHA) data. Additionally, there were 

differences in criteria for hospitals’

inclusion in the study between the 

original Harvard study and the CMScontracted study, as well as differences 

between those studies and the AOPO 

study. 

However, the primary reason the 

models produced such imprecise 

estimates is that they are based on 

regression analysis. Regression analysis 

is a method for estimating the statistical 

association between a group of 

independent (or predictor) variables and 

a dependent (or outcome) variable. 

Regression analysis can be used to test 

a hypothesis by determining how a 

change in one or more of the 

independent variables affects the value 

of the dependent variable. Both the 

Harvard and AOPO researchers tested 

the effect of a variety of hospital 

characteristics, such as number of full 

time equivalent positions (an 

independent variable) on the number of 

potential donors in a hospital (the 

dependent variable).

The development of a regression 

model involves: (1) Initial selection of 

variables that are believed to have 

predictive potential; (2) collecting and 

organizing the data on the chosen 

variables; (3) testing the correlation 

between the variables; (4) choosing 

independent variables with a low degree 

of correlation between themselves and a 

high degree of correlation with the 

dependent variable; and (5) validating 

the results against results obtained 

through a previously tested method (for 

example, through death record reviews). 

The objective is to develop a model that 

uses the least amount of independent 

variables necessary to have the greatest 

amount of predictive capability and 

which uses data that can be updated 

routinely from existing sources, such as 

AHA data. However, the model cannot 

be used indefinitely without 

revalidation to determine whether the 

independent variables remain 

predictive. Thus, in order to use the 

Harvard and AOPO regression models 

for certification purposes, they would 

have to be revalidated periodically 

using death record reviews. 

Since they are based on regression 

analysis, both models produce an 

estimate of potential donors with a 

range (plus or minus) within which, 

statistically, there is a 95 percent 

probability that the true number of 

potential donors lies. This range is 

called the ‘‘confidence interval.’’ The 

range of the confidence interval is 

determined as illustrated in the 

following example. If the number of 

potential donors based on regression 

analysis is determined to be 100 and the 

confidence interval is 46, the range of 

the confidence interval is calculated by 

subtracting one half of the confidence 

interval from the number of potential 

donors (that is, one half of 46 is 

subtracted from 100 (100–23=77)) and 

adding one half of the confidence 

interval to the number of potential 

donors (that is, one half of 46 is added 

to 100 (100+23=123)). Thus, the range of 

the confidence interval in this example 

would be between 77 and 123, and one 

could be 95 percent certain that the 

number of potential donors was 

between 77 and 123. 

The wider the confidence interval, the 

less certainty there is that the model 

works well as an estimate of the number 

of potential donors in a particular OPO’s 

service area. Large intervals generally 

occur in OPO service areas with a small 

number of estimated potential donors or 

a small number of hospitals. In fact, 

Harvard has stated it does not believe its 

model produced an accurate estimate of 

the number of potential donors in eight 

OPO service areas that have only a small 

number of hospitals.

As an example, Harvard estimated 

that one small OPO had 96 potential 

donors in 1998, with a confidence 

interval width of 120; that is, one can be 

95 percent confident that the actual 

number of potential donors was 

between 36 and 156. Similarly, AOPO 

estimated that a small OPO had 57 

potential donors with a confidence 

interval width of 82; that is, one can be 

95 percent confident that the actual 

number of potential donors was 

between 16 and 98. Obviously, it would 

be problematic to use estimates with 

such large confidence intervals for 

certifying OPOs. 

However, even for large OPOs, the 

two models produce ranges that are 

unacceptably large for certification 

purposes. One of the largest of the 16 

OPOs in the AOPO study was estimated 

to have 395 potential donors with an 

interval width of 93, that is, one can be 

95 percent certain that the number of 

potential donors was between 349 and 

442. Harvard estimated that the same 

OPO had 740 potential donors, with an 

interval width of 312, that is, one can be 

95 percent certain that the number of 

potential donors was between 583 and 

896. 

Overall, the Harvard model estimates 

a much larger number of potential 

donors than the AOPO model for most 

individual OPO service areas. The 

Harvard model also estimates a much 

larger pool of donors nationwide than 

the AOPO model—11,700 to 21,800 

potential organ donors annually to 

AOPO’s 11,000 to 14,000 potential 

donors annually. It is certainly possible 

to debate the reasons for the disparities 

in estimates between the two models 

(both nationwide and in individual 

service areas). For example, the Harvard 

model was tested and validated in only 

3 OPO service areas, whereas the AOPO 

model was tested and validated in 16 

and, thus, may be more accurate. 

However, regardless of the reason for 

the difference in estimates of the 

number of potential donors between the 

two models, the central fact remains 

that they are unreliable estimates and, 

therefore, unacceptable for OPO 

certification purposes. 

To demonstrate the effect of using 

those estimates to rate an OPO’s 

performance, we can look at the large 

OPO that was estimated by the AOPO 

study to have 395 potential donors and 

use a hypothetical example to suppose 

that in 1998 the OPO had 180 donors, 

or a conversion rate (that is, the number 

of donors from whom organs are 

recovered for the purpose of 

6098 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

transplantation as a percentage of the 

number of potential donors) of 

approximately 46 percent. (The average 

conversion rate for the 16 OPOs in the 

AOPO study was 50 percent.) If, 

however, the OPO’s actual number of 

potential donors was at the bottom of 

the confidence interval (349), its 

conversion rate was actually an aboveaverage 52 percent, but if the actual 

number of potential donors was at the 

top of the confidence interval (442), its 

conversion rate was only 41 percent, 

which is well below average. 

For smaller OPOs, the effect of the 

confidence interval is much greater, and 

could result in re-certification of a poor 

OPO or de-certification of a good OPO. 

For example, if we look at the small 

OPO estimated by AOPO to have 57 

potential donors (with a confidence 

interval between 16 and 98 potential 

donors) and use a hypothetical example 

to suppose that it had 12 donors, its 

conversion rate based on its estimated 

potential of 57 donors is an abysmal 21 

percent, and the OPO would very likely 

be de-certified. If the OPO’s potential 

were at the top of the confidence 

interval (98 potential donors), the OPO 

looks even worse—with a conversion 

rate of only 12 percent. However, if the 

OPO’s potential were at the bottom of 

the confidence interval (16 potential 

donors), its conversion rate would be an 

impressive 75 percent, and the OPO 

would be considered a top performer. 

Our analysis of the Harvard and 

AOPO data showed that in some cases, 

as would be expected, the number of 

potential donors as determined by 

AOPO’s 1998 death record reviews fell 

outside the confidence interval 

predicted by both models. Consider the 

example of one OPO estimated to have 

192 potential donors using the AOPO 

model (confidence interval 152–232) 

and 197 potential donors using the 

Harvard model (confidence interval 

135–259). According to AOPO’s death 

record reviews, the OPO’s actual 

number of potential donors was 130. 

Using a hypothetical example, we can 

suppose that the OPO had 65 donors in 

1998. Thus, its conversion rate based on 

the AOPO death record reviews would 

have been 50 percent—average 

according to the AOPO study of 16 

OPOs. However, according to the AOPO 

model, the OPO’s conversion rate would 

have been only 34 percent; and 

according to the Harvard model, its 

conversion rate would have been 33 

percent. With a threshold for recertification established at 75 percent of 

the mean 50 percent conversion rate 

(37.5 percent), the OPO could have 

faced de-certification. 

2. AOPO Recommendations 

The AOPO has long been a champion 

of replacing population-based outcome 

performance standards with measures 

based on the number of potential 

donors. The goal of AOPO’s death 

record review study was to find an 

alternative to population that would be 

a reasonably accurate measure of the 

number of potential donors. However, 

in a series of meetings with us to 

discuss the results of its death record 

review study, the AOPO did not 

recommend using either the AOPO or 

the Harvard methodologies to estimate 

donor potential in individual OPO 

service areas.

Instead, in written proposals to us 

dated February 28, 2001 and April 25, 

2001, the AOPO recommended outcome 

measures based on both population and 

the number of potential donors as 

determined by death record reviews. 

AOPO’s recommended outcome 

measures would consist of a two-tiered 

system for OPO certification that would 

rely on population in the first tier and, 

for OPOs that failed the first-tier 

measures, the number of potential 

donors determined by death record 

reviews in the second tier. 

The AOPO recommended that we 

retain the 5 factors currently used to 

measure OPO performance, that is, 

donors, kidneys procured, kidneys 

transplanted, extra-renal organs 

procured, and extra-renal organs 

transplanted. They recommended that: 

(a) In the first tier, OPOs be screened 

using the current population-based 

performance standards, that is, OPOs 

would have to meet 4 out of the 5 

current performance standards at 75 

percent of the mean (2 performance 

standards at 50 percent of the mean for 

OPOs operating exclusively in noncontiguous States or territories) to pass 

the first tier; (b) an OPO not meeting the 

first-tier outcome measures be required 

by us to submit data for all deaths 

occurring in hospitals in its service area 

with 150 beds or more; (c) OPOs be recertified if their death record review 

data indicated a conversion rate of at 

least 50 percent of the national mean 

conversion rate found in the AOPO 

study of 30 OPOs (including the 14 

OPOs that furnished incomplete data); 

and (d) the national conversion rate be 

updated every 4 to 5 years. 

C. Outcome Measures 

1. Problems With Two-Tier Assessment 

AOPO’s recommended two-tier 

process relies primarily on populationbased measures. In fact, the first tier is 

identical to the existing performance 

standards, and few, if any, OPOs would 

be assessed using second-tier measures 

based on death record reviews. 

AOPO has criticized the current 

population-based performance 

standards because they fail to take into 

account factors that negatively impact 

the number of potential donors in an 

individual OPO’s service area, such as 

high rates of HIV/AIDS and low motor 

vehicle accident and homicide rates. 

They argue that population-based 

measures cause some good OPOs to look 

like poor performers. However, the 

reverse is also true—factors in some 

OPO service areas, such as low rates of 

HIV/AIDS and high motor vehicle 

accident and homicide rates, may create 

a relatively high donor potential, 

making OPOs whose actual performance 

is below average look like good 

performers. 

The implications of this are clear. The 

two-tier method might prevent decertification of good OPOs by giving 

OPOs that may be disadvantaged by 

population-based measures an 

opportunity to prove they are good 

performers by submitting results from 

death record reviews. However, the twotier method would not prevent recertification of poorly performing OPOs 

that may appear to be good performers 

using population-based measures. 

In the congressional findings 

associated with section 219 of the 

Consolidated Appropriations Act, 2001 

(Pub. L. 106–554), Congress directed the 

Secretary to develop measures that 

‘‘accurately measure performance 

differences among the organ 

procurement organizations.’’ We do not 

believe a two-tier method with the first 

tier based on population is a reliably 

accurate methodology for assessing OPO 

performance, and we do not believe recertification of OPOs should be based 

on an inaccurate methodology. 

Furthermore, we believe it is incumbent 

upon the agency, as both a prudent 

purchaser of health care services and a 

guardian of the organ donation system 

in the United States, to propose an 

accurate measure of OPO performance 

‘‘based on empirical evidence, obtained 

through reasonable efforts, of organ 

donor potential and other related factors 

in each service area of qualified organ 

procurement organizations,’’ as 

Congress clearly intended in 42 U.S.C. 

273(b)(1)(D)(ii). Such a measure should 

enable the Secretary and the public to 

distinguish between good OPOs and 

poor OPOs. 

In addition to its reliance on 

population-based measures in the first 

tier, another drawback of the two-tier 

process proposed by AOPO is that in 

order to use death record review results 

in the second tier, we initially would 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6099

need to calculate a national conversion 

rate to which OPOs could be compared 

and then recalculate the conversion rate 

periodically—probably every 4 to 5 

years. AOPO has suggested that we 

determine the national conversion rate 

through a sample of death records from 

hospitals throughout the United States. 

We believe this process would go far 

beyond the ‘‘reasonable effort’’ Congress 

envisioned for determining donor 

potential.

Furthermore, in order to have the 

national conversion rate available to us 

shortly after the close of a recertification cycle, a national sample 

would have to be calculated well in 

advance of the end of the re-certification 

cycle to allow us sufficient time to find 

a contractor and to allow the contractor 

sufficient time to design and conduct a 

study and analyze the results. However, 

if all OPOs passed the first tier at the 

conclusion of the re-certification cycle, 

CMS would have no need of the 

national conversion rate that it had 

obtained. We believe there is a simpler, 

more accurate, and more reliable 

method of measuring an OPO’s 

performance according to its donor 

potential. 

2. OPTN Data as Alternative Data 

Source 

We propose eliminating the use of 

population-based standards and, 

instead, basing outcome measures 

entirely on organ donor potential. Organ 

donor potential (that is, the number of 

potential organ donors) would be 

determined by data reported by OPOs to 

the OPTN, based primarily on referral 

calls the OPOs receive from hospitals. 

We believe this system would be 

simple, straightforward, and easy for 

OPOs and the public to understand. 

Furthermore, the OPOs already report 

data on organ donor potential to the 

OPTN. 

OPOs report certain data elements to 

the OPTN whenever they query the 

OPTN’s system to find a match for a 

potential donor, and the OPTN has a 

sophisticated system in place to capture 

this information electronically. As part 

of its efforts to monitor the impact of the 

hospital CoP (condition of participation) 

for organ, tissue, and eye procurement), 

the Health Resources and Services 

Administration (HRSA) asked the OPTN 

in 2001 to begin collecting additional, 

hospital-specific data from OPOs, 

including the number of referral calls 

OPOs receive from hospitals reporting 

deaths and imminent deaths, the 

number of referrals meeting organ donor 

eligibility criteria (that is, the number of 

potential donors), and the number of 

consents obtained on referrals meeting 

organ donor eligibility criteria. Data are 

reported monthly for deaths occurring 

during the previous month. The data are 

obtained by the OPOs from referral calls 

hospitals and critical access hospitals 

are required to make to OPOs by the 

hospital CoP (see §§ 482.45 and 

485.643) and are supplemented by data 

gathered by OPOs onsite at their 

hospitals. OPOs began reporting the 

data to the OPTN in September 2001. 

In the first few months of the data 

collection, HRSA and the OPTN found 

many instances of incomplete data 

reporting by the OPOS, particularly the 

number of deaths and imminent deaths. 

However, the completeness of these data 

is improving. OPOs reported 

approximately 900,000 deaths and 

imminent deaths in 2002 (a known 

undercount), which is not far from the 

982,914 inpatient hospital deaths 

reported by the National Center for 

Health Statistics for 2000. The number 

of potential donors reported by OPOs 

(termed ‘‘eligible deaths’’ by the OPTN 

and SRTR) for 2002 is consistent with 

estimates of the annual number of 

potential donors made by the organ 

donation community. HRSA and the 

OPTN continue to work with OPOs to 

further improve the database. We expect 

that if these data are used for 

certification purposes, the completeness 

of the data will approach 100 percent. 

To assess the accuracy of the data 

OPOs are reporting to the OPTN, the 

SRTR recently analyzed the ability of 

‘‘eligible deaths’’ data to predict the 

actual number of donors. They 

compared ‘‘eligible deaths,’’ as well as 

the number of potential donors 

estimated by the Harvard model with 

the actual number of donors. The 

researchers found ‘‘eligible deaths’’ to 

be substantially more predictive of 

actual donors. The SRTR noted that 

more complete data reporting by OPOS 

to the OPTN will improve the reliability 

of the data. (‘‘New Methods for 

Estimating Total Potential (Organ) 

Donors in the U.S.’’ J McGowan, M 

Guidinger, R Pietroski, D Gaylin, A Ojo, 

et al. Abstract presented at American 

Transplantation Congress meeting, 

Washington DC, May 30–June 4, 2003.) 

3. Standardized Definition of Organ 

Donor Potential 

Our proposed definition is based on 

patient age, cause of death, and comorbid conditions that contraindicate 

donation. We would use the following 

definition of ‘‘organ donor potential’’: 

the number of patients whose age is 70 

or less meeting death by neurological 

criteria, based on generally accepted 

practice parameters for determining 

brain death, who do not have any of the 

following clinical indications: 

• Tuberculosis. 

• Creutzfeldt-Jacob disease or any 

other prion-induced disease. 

• Viral septicemia. 

• Rabies. 

• Reactive hepatitis B surface antigen. 

• Any retro virus infection. 

• Active malignant neoplasms, except 

primary central nervous system tumors 

and basal cell and squamous cell 

carcinomas.

• Aplastic anemia. 

• Agranulocytosis. 

• Active viral and systemic fungal 

infections. 

• Gangrene of bowel. 

• Extreme prematurity. 

• Positive serological or viral culture 

findings for HIV. 

• Chagas Disease. 

Although the upper age limit for 

donation continues to rise as OPOs and 

transplant programs become 

increasingly willing to consider 

recovering and transplanting ‘‘expanded 

criteria’’ organs, almost all organs come 

from donors younger than 70. Therefore, 

we propose limiting the definition of 

‘‘organ donor potential’’ to donors of age 

70 and below. We propose limiting the 

definition to include only deaths from 

neurological causes (that is, brain death) 

rather than including non-heartbeating 

donation (also called donation after 

cardiac death (DCD)). Although DCD is 

becoming more common, it remains the 

exception; in 2000, there were only 119 

non-heartbeating donors, and in 2001, 

there were only 167. We are proposing 

rule-out criteria that are generally 

accepted by the organ donation and 

transplantation community as 

precluding organ donation because 

these co-morbid conditions render an 

individual medically unsuitable for 

organ donation. However, we are 

specifically requesting public comments 

regarding our proposed definition. 

We propose using a specific term, 

‘‘potential donor denominator,’’ for the 

data on organ donor potential OPOs 

would report to the OPTN. The 

potential donor denominator would 

indicate the number of individuals in an 

OPO’s service area who meet the criteria 

for organ donor potential, as defined by 

regulations. The term ‘‘potential donor 

denominator’’ would differentiate the 

data OPOs would report to the OPTN 

from data based on other definitions of 

‘‘potential donor’’ or ‘‘organ donor 

potential’’ used in the OPO community. 

Because definitions vary among 

OPOs, the universe of potential donors 

we would use for OPO certification 

could be different from that used by 

some OPOs. For example, an OPO that 

6100 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

has liberal donor criteria (perhaps 

including recovery of non-heartbeating 

donors) would consider itself to have a 

larger number of potential donors than 

the number it reports to the OPTN for 

the ‘‘potential donor denominator.’’ In 

these instances, OPOs would be able to 

exceed 100 percent of the standard. 

Conversely, an OPO with conservative 

donor criteria would consider itself to 

have a smaller number of potential 

donors than the number it reports to the 

OPTN. 

Determining whether organs should 

be recovered and transplanted is a 

medical decision; therefore, our 

proposed definition is not intended to 

limit the donors or organs an OPO 

recovers for transplantation. We are 

aware that many OPOs are successfully 

recovering transplantable organs from 

donors that do not fall within our 

proposed definition. 

4. OPTN Data 

In outlining the limitations of the 

current re-certification process, 

Congress noted that outcome and 

process performance measures should 

be considered that would ‘‘more 

accurately reflect the relative capability 

and performance of each organ 

procurement organization.’’ We believe 

that basing multiple outcome measures 

on potential donor denominator data 

reported to the OPTN, as we propose, 

would give us, each OPO, the organ 

donation and transplantation 

community, and the public a clear 

picture of OPO capability and 

performance and eliminate possible 

inaccuracies and inconsistencies 

associated with current populationbased standards.

Using potential donor denominator 

data reported to the OPTN would have 

additional significant advantages. 

Congress required the Secretary to 

propose standards based on ‘‘empirical 

evidence, obtained through reasonable 

efforts’’ of organ donor potential. Thus, 

we believe that Congress expected that 

the outcome measures data would be 

verifiable and that the processes used to 

obtain and verify the data would be 

practical and sensible. 

The SRTR has developed a 

methodology that is being used to 

validate the data OPOs report to the 

OPTN. The methodology is based on 

readily available data on hospital bed 

size and other factors, as well as 

hospital death data obtained from the 

National Center for Health Statistics. If 

data reported by an OPO appear to be 

incorrect, the SRTR performs further 

analysis, and the data is corrected if 

necessary. We are confident that the use 

of this methodology would ensure that 

the data used for OPO certification are 

accurate. 

OPTN data also would be verified by 

hospital surveyors when they review 

data on hospital deaths and hospital 

death records to verify hospital and 

critical access hospital compliance with 

the CoPs. In addition, since we propose 

requiring OPOs to publish hospitalspecific organ donation data annually 

(see proposed § 486.328), hospitals 

could verify their own data to ensure 

OPOs are reporting data accurately to 

the OPTN. Certainly, using OPTN data 

would be both sensible and practical 

because the OPTN already has a system 

in place to collect and verify the data, 

and all 59 OPOs have the capability to 

report the data electronically. 

5. Death Record Reviews as Alternative 

Data Source 

Because death record reviews are 

considered by the OPO community to be 

the ‘‘gold standard’’ for estimating the 

number of potential donors in a 

hospital, we considered proposing 

outcome measures based entirely on 

data derived from OPOs’ reviews of 

hospital death records. GAO gave 

serious consideration in its 1997 report 

to the use of death record reviews 

performed by OPOs to determine the 

number of potential donors for OPO 

certification. However, there are a 

number of disadvantages to basing 

certification on death record review 

data. In fact, the GAO report noted 

drawbacks to using OPO-conducted 

death record reviews, including the cost 

of the reviews and the challenge of 

maintaining consistency in the reviews. 

Maintaining consistency in 

performing death record reviews for 

certification purposes would be 

difficult, because we would have to 

ensure that all 59 OPOs performed the 

reviews in the same manner. This 

would require development of a 

standardized protocol for the reviews, as 

well as ongoing, nationwide training for 

OPOs in hospital selection, sampling, 

record review, and reporting. 

Furthermore, it would be difficult for 

many OPOs to complete death record 

reviews for the final year of the recertification cycle in time for us to use 

the data for re-certification. (Note that 

while we propose requiring all OPOs to 

perform death record reviews as part of 

their QAPI programs (see proposed 

§ 486.348), death record reviews 

performed by OPOs for their own 

purposes would not require 

standardization across OPOs because 

the reviews would be performed solely 

to provide data for quality improvement 

for each individual OPO.) 

Therefore, in weighing the two 

methods of determining the number of 

potential donors (data reported by 

hospitals to OPOs and by OPOs to the 

OPTN or death record reviews 

performed by OPOs), we believe that 

using OPTN data most clearly fulfills 

Congress’s intention in requiring 

promulgation of measures based on 

‘‘empirical evidence, obtained through 

reasonable efforts.’’ OPTN data would 

provide an accurate measure of organ 

donor potential and OPO performance, 

and using OPTN data would be simple 

and straightforward because a system is 

already in place to report, capture, and 

disseminate the data.

We propose that potential donor 

denominator data reported to the OPTN 

to be used for OPO re-certification 

include data for all deaths that occur in 

Medicare and Medicaid participating 

hospitals in an OPO’s service area, 

unless a hospital has received a waiver 

to work with a different OPO. At 

present, OPOs are reporting data to the 

OPTN within 30 days of the end of the 

month in which a death occurred, and 

we propose requiring that OPOs 

continue to report their data within this 

time frame. We believe this provides 

adequate time for OPOs to report data, 

while ensuring that data will be 

available to us when needed for 

certification purposes. (This proposal 

can be found in the proposed condition 

for reporting of data at § 486.328(b).) 

To ensure accuracy, OPOs would 

need to report the potential donor 

denominator data consistently, adhering 

strictly to the criteria in the proposed 

definition for organ donor potential. 

Reporting the data ‘‘consistently’’ means 

that if the OPO determined at any time, 

from the referral of a patient by a 

hospital through recovery and testing of 

the patient’s organs, that the patient met 

any of the rule-out criteria listed in the 

definition, the patient would be 

eliminated as a potential donor and 

would not be reported to the OPTN 

under this regulation. If an OPO 

determined through death record 

reviews or other means that the 

potential donor denominator data it 

reported to the OPTN was incorrect, the 

OPO would be required to report the 

corrected data to the OPTN within 30 

days of the end of the month in which 

the mistake is identified. (This proposed 

requirement can be found in the 

proposed condition for information 

management at § 486.328(b).) 

However, while we propose basing 

OPO outcome measures on the number 

of potential donors as evidenced by 

OPTN data, we are specifically 

requesting comments on the feasibility 

of basing OPO outcome measures on the 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6101

number of potential donors as 

determined by death record reviews. 

6. Outcome Performance Standards and 

Thresholds 

With the exception of OPOs operating 

exclusively in non-contiguous U.S. 

States, territories, possessions, or 

commonwealths, we propose an OPO 

certification threshold of 75 percent of 

the national mean for 4 out of 5 of the 

following outcome measures, averaged 

over the 4 calendar years before the year 

of re-certification: (1) Donors as a 

percentage of the potential donor 

denominator; (2) number of kidneys 

procured, as a percentage of the 

potential donor denominator; (3) 

number of kidneys transplanted, as a 

percentage of the potential donor 

denominator; (4) number of extra-renal 

organs procured, as a percentage of the 

potential donor denominator; and (5) 

number of extra-renal organs 

transplanted, as a percentage of the 

potential donor denominator. 

These five OPO performance factors 

are the same as those used in the current 

outcome performance standards. 

However, the outcome performance 

measures we propose would be based 

on the organ donor potential in an 

OPO’s service area, rather than the 

population in the service area. We are 

proposing the same performance factors 

because they represent the totality of 

what an OPO does—from identifying 

and managing potential donors through 

ensuring delivery of healthy organs to 

hospitals for transplantation. 

An OPO operating exclusively in noncontiguous States, territories, 

possessions, or commonwealths would 

be required to meet the following 

outcome measures at 50 percent or more 

of the national mean, averaged over the 

4 calendar years before the year of recertification: (1) Number of kidneys 

procured, as a percentage of the 

potential donor denominator; and (2) 

number of kidneys transplanted, as a 

percentage of the potential donor 

denominator. As in the current 

regulations, OPOs operating in noncontiguous areas would be required to 

meet measures only for kidneys 

procured and kidneys transplanted 

because there are few extra-renal 

transplant programs located in noncontiguous areas and because the 

permissible cold ischemic time for 

extra-renal organs is shorter than that 

for kidneys, making shipment of extrarenal organs to the continental U.S. for 

transplantation problematic.

We believe all 5 proposed outcome 

measures are critical for assessing 

performance of OPOs located in the 

continental United States because, taken 

together, they reflect the entire spectrum 

of the donation process for which those 

OPOs are responsible. Furthermore, 

although it is true that organs recovered 

by an OPO for transplantation 

sometimes are discarded (or used for 

research instead of transplantation) for 

reasons beyond the control of the OPO, 

OPOs are responsible for the majority of 

functions that determine whether an 

organ is transplanted (for example 

testing, recovery of the organ, 

packaging, and transport). Nevertheless, 

since there is some disagreement in the 

OPO community on this issue, we are 

specifically requesting public comments 

on the need for each of the five 

measures. 

Under current regulations, OPOs 

report outcome performance data to us 

only for pancreata procured for whole 

organ transplantation. However, 

legislation enacted on October 25, 2004 

(Pub. L. 108–362) which amends section 

371 of the PHS Act, requires that 

pancreata recovered and used for islet 

cell transplantation or for research be 

counted for purposes of OPO 

certification and re-certification. 

Therefore, when compiling outcomes 

performance measures data and 

utilizing the data for re-certification of 

OPOs, we will include pancreata 

recovered and used for islet cell 

transplantation or for research under the 

category of extra-renal organs, along 

with pancreata recovered and used for 

whole organ transplantation. Also, 

because researchers and OPOs have 

suggested that we encourage OPOs to 

recover other organs for research 

purposes, we invite comment on 

whether all organs recovered for 

research should be included in the 

outcome measures. 

When the current outcome 

performance standards were 

established, we deliberately set the 

threshold for re-certification at a point 

we thought would prevent decertification of good OPOs based on 

what may have been imprecise 

population-based performance 

standards. It would seem logical that 

along with adopting more precise 

outcome measures, we would raise the 

threshold for re-certification. However, 

since measures based on a potential 

donor denominator have never been 

used for OPO certification, we are 

somewhat reluctant to propose a change 

in the threshold for re-certification that 

might result in the de-certification of 

many OPOs. Nevertheless, we are 

specifically requesting public comment 

on the following three issues: (1) 

Whether OPOs located in the 

continental U.S. should be required to 

meet more (or less) than 75 percent of 

the national mean and, if so, the 

appropriate percentage threshold; (2) 

whether OPOs operating in noncontiguous states or territories should be 

required to meet more (or less) than 50 

percent of the national mean; and (3) 

whether OPOs located in the 

continental U.S. should be required to 

meet all 5 (instead of just 4) measures. 

OPO Process Performance Measures 

Condition: Participation in Organ 

Procurement and Transplantation 

Network (Proposed § 486.320) 

Current OPO regulations at § 486.308 

require OPOs to be members of and 

abide by the rules of the OPTN, and we 

propose to retain this requirement. 

However, we propose eliminating the 

requirement for an OPO to become an 

OPTN member before becoming 

designated by us because the OPTN 

requires an OPO to furnish information 

demonstrating designation by us to 

become a member of the OPTN. (See 42 

CFR 121.3(b)(2).) Therefore, we propose 

that only after being designated would 

an OPO be required to be a member of 

the OPTN. In addition, we propose to 

eliminate the requirement that OPOs 

have a written agreement with the 

OPTN because a written agreement is 

not part of the OPTN membership 

process.

Condition: Relationships With 

Hospitals, Critical Access Hospitals, and 

Tissue Banks (Proposed § 486.322) 

[If you choose to comment on this 

section, please include the caption 

‘‘Relationships with hospitals’’ or 

‘‘Relationships with tissue banks’’ at the 

beginning of your comments as 

appropriate.] 

Good relationships between OPOs 

and organizations involved in the 

donation process often result in more 

efficient operations, such as shared 

referral lines for hospitals to use when 

calling about deaths and collaboration 

between OPOs and tissue banks in 

training hospital designated requestors. 

Furthermore, collaboration and 

cooperation between donation 

organizations promotes a positive public 

opinion about donation. 

All six OPOs whose practices were 

studied for the Organ Donation 

Breakthrough Collaborative have strong 

collaborative relationships with their 

hospitals. Donor Alliance in Colorado 

has 6 full-time ‘‘donation consultants,’’

who are liaisons to the 100 hospitals in 

the OPO’s service area and provide 

professional education and feedback. Inhouse coordinators from LifeGift Organ 

Donation Center in Houston meet 

regularly with hospital medical staff to 

6102 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

review organ donation cases. The 

University of Wisconsin OPO ‘‘views 

hospital staff as an extension of OPO 

staff, contributing to the achievement of 

OPO goals.’’ Their OPO staff encourage 

physicians, nurses, and pastoral care 

staff to participate in the donation 

process and provide support and 

guidance. 

Collaboration between OPOs and 

hospitals is absolutely critical to the 

donation process. Good relationships 

encourage cooperation from hospital 

staffs in making referrals of potential 

donors timely, supporting OPOs in 

discussing donation with families (or 

acting as designated requestors), and 

providing support services for 

management of potential donors. We 

expect that the requirements we propose 

will increase communication and 

cooperation between OPOs and the 

hospitals in their service areas. 

The current regulations at § 486.306(g) 

require OPOs to have a working 

relationship with at least 75 percent of 

the Medicare and Medicaid 

participating hospitals in their service 

areas that have an operating room and 

the equipment and personnel for 

retrieving organs. Regulations at 

§ 486.304(b)(8) require OPOs to have a 

working relationship with any hospital 

in the service area, including a 

transplant hospital that requests a 

working relationship. Furthermore, the 

hospital and critical access hospital 

CoPs for organ, tissue, and eye 

procurement require all Medicare and 

Medicaid participating hospitals and 

critical access hospitals to have and 

implement an agreement with an OPO 

designated under part 486 that includes 

a protocol for referral of all deaths and 

imminent deaths. (See §§ 482.45 and 

485.643.) 

We considered proposing a rule that 

would require an OPO to have an 

agreement with every hospital and 

critical access hospital in its service area 

(unless a hospital had a waiver to work 

with a different OPO) to ensure that 

OPOs do not overlook a single potential 

donor. However, the PHS Act requires 

only that an OPO have agreements with 

a ‘‘substantial majority’’ of hospitals in 

its service area that have facilities for 

organ donation. 

Therefore, we propose maximizing 

the number of hospitals with which 

OPOs have agreements (consistent with 

the PHS Act) by requiring OPOs to have 

agreements with 95 percent of the 

hospitals and critical access hospitals in 

their service areas that have both a 

ventilator and an operating room. (Note:

If a hospital received a waiver from us 

to work with another OPO, the hospital 

would not be counted as part of the 

OPO’s service area.) Since it is 

necessary for a hospital to have a 

ventilator to maintain a potential donor 

and an operating room for recovery of 

organs, we believe a requirement for 

OPOs to have agreements with 95 

percent of hospitals and critical access 

hospitals with a ventilator and an 

operating room would capture a 

‘‘substantial majority’’ of hospitals with 

facilities for organ donation. 

Our OPO Coordinators have found 

that most OPOs ask their hospitals to 

sign a ‘‘generic’’ agreement that does not 

address each entity’s role in the 

donation process and does not define 

key terms, such as ‘‘imminent death’’

and ‘‘timely referral.’’ This lack of 

specificity can lead to problems; for 

example, disagreement between an OPO 

and hospital about their respective roles 

in discussing donation with families, 

differing viewpoints of OPO staff and 

hospital physicians regarding what 

constitutes ‘‘imminent death,’’ or 

disagreements between an OPO and 

hospital about the appropriate timing of 

referrals to the OPO. However, the 

Coordinators have observed that where 

OPOs network with their hospitals to 

clearly define roles and responsibilities 

for the donation process, referral rates 

are higher.

Therefore, to avoid problems, promote 

collaboration, and assure that OPOs’

agreements with their hospitals support 

the overall goal of maximizing organ 

donation and transplantation, we 

propose requiring that OPOs’

agreements with hospitals and critical 

access hospitals must describe the 

responsibilities of both the OPO and the 

hospital in regard to the hospital 

requirements at §§ 482.45 or 485.643, as 

appropriate, (for example, how referrals 

will be made and how collaboration in 

reviewing death records will occur) and 

specify the meaning of the terms, 

‘‘timely referral’’ and ‘‘imminent death.’’

One of our proposals for OPOs’

relationships with their hospitals is 

based on observations made by the 

Office of the Inspector General (OIG) in 

its August 2000 report on the hospital 

CoP. The OIG noted that although 

research shows that collaboration 

between OPOs and hospitals in 

approaching families about organ 

donation yields the highest consent 

rates, the OIG found that 23 out of 61 

OPOs had not provided any training to 

hospital staffs. Only 22 OPOs had 

trained designated requestors in more 

than 10 percent of the hospitals in their 

service areas. (A ‘‘designated requestor’’

under the hospital CoP is an individual 

who has been trained in a course offered 

or approved by the OPO to discuss 

donation with families of potential 

donors. See § 482.45(a)(3).) 

The OIG estimated that 70 percent of 

hospitals had been offered designated 

requestor training by their OPOs; 

however, staff in only 44 percent of 

hospitals had been trained. The OIG 

suggested this could be due to ‘‘a 

number of practices that indicate OPO 

resistance to training and using hospital 

staff as designated requestors.’’ They 

noted that some OPOs make it difficult 

for hospitals staffs to attend training (for 

example, holding training sessions 

several hundred miles away from 

hospitals), and other OPOs establish 

programs that lack the flexibility to 

respond to the needs of various types of 

hospitals and individuals. 

Although CMS intended the 

designated requestor requirement in the 

hospital CoP to lead to more 

collaboration between OPOs and 

hospitals and increased hospital 

involvement in the donation process, 

the OIG commented that the 

requirement may have had the opposite 

effect. That is, since OPOs are reluctant 

to train hospital staffs and to involve 

them in the donation process, some 

hospitals are allowing OPOs to take over 

the entire donation process. 

Nevertheless, in some OPO service 

areas, the OPO handles most or all 

requests for donation, and consent rates 

are good. In other areas, hospitals 

cannot spare staff to attend designated 

requestor training, and the hospital and 

critical access hospital CoPs makes it 

clear that the hospital, not the OPO, has 

the right to decide whether an OPO 

representative or a hospital designated 

requestor will offer the option of 

donation. Based on these facts, we do 

not believe it would be advisable to 

require every OPO to provide 

designated requestor training in every 

hospital and critical access hospital in 

its service area. Instead, we propose 

requiring OPOs to offer designated 

requestor training on at least an annual 

basis for hospital and critical access 

hospital staffs. We propose that training 

be offered at least annually because 

most hospital staff do not discuss 

donation with families frequently 

enough to maintain their proficiency 

unless they receive periodic training. 

We urge OPOs to encourage 

designated requestor training so that 

hospital staff can support and 

collaborate with OPO staff in the 

donation process. We applaud the 

efforts of OPOs like LifeLine of Ohio 

that actively promote designated 

requestor training in hospitals. In its 

‘‘Quest for Excellence’’ in educating 

hospitals, LifeLine made it possible for 

staff in those hospitals to earn free 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6103

continuing education credits by 

completing designated requestor 

training, either in the hospital or via the 

Internet. In the University of Wisconsin 

OPO service area, hospital staff are the 

primary requestors. OPO staff conducts 

a designated requestor training program 

and ongoing training and case reviews 

at hospitals to educate hospital staff 

about all aspects of organ donation, 

including case management. 

Before the CoP, hospitals called tissue 

banks about potential tissue donors and 

called OPOs about potential organ 

donors. However, the hospital CoP at 

§ 482.45 and critical access hospital CoP 

at § 485.643 require hospitals and 

critical access hospitals to refer all 

deaths and imminent deaths (rather 

than just potential organ donors) to an 

OPO. The hospital and critical access 

hospital CoPs state that in the absence 

of alternative arrangements between a 

hospital and a tissue bank, the OPO will 

determine suitability for tissue 

donation. However, after the hospital 

CoP went into effect in August 1998, 

very few hospitals were willing to have 

‘‘alternative arrangements’’ that would 

have required them to call tissues banks 

about potential tissue donors in 

addition to calling an OPO about every 

death. Thus, in most areas of the 

country, OPOs became the 

‘‘gatekeepers’’ for information about 

potential tissue donors. Since many 

OPOs are in the tissue banking business, 

the OPOs’ gatekeeper position created 

some tension between a few OPOs and 

the independent tissue banks in their 

service areas.

We have received complaints both 

from tissue banks and OPOs. Tissue 

banks have charged that OPOs fail to 

notify them about potential tissue 

donors in a timely manner, charge 

unreasonable referral fees for notifying 

them of potential donors, refuse to allow 

tissue banks to participate in designated 

requestor training sessions OPOs 

provide to hospitals, or refuse to use the 

tissue banks’ screening and notification 

protocols when referring donors. 

For their part, OPOs have complained 

that some tissue banks have paid no 

referral fees since the hospital CoP went 

into effect in August 1998. (We require 

OPOs to charge tissue banks for their 

costs in making referrals so that the 

costs are not passed on to the Medicare 

program. (See Medicare Provider 

Reimbursement Manual, section 

2773.1)) In addition, some OPOs have 

charged that tissue banks do not 

respond timely to the referrals they 

receive, resulting in the loss of viable 

tissue. Since donor families and the 

public often regard all donation as organ 

donation, that loss of donation potential 

in a donor for whom consent has 

already been obtained may reflect badly 

on the OPO, rather than the tissue bank. 

Clearly, difficult relationships 

between OPOs and the tissue banks in 

their service areas waste valuable time 

and energy and distract OPOs from their 

mission of maximizing organ donation. 

Therefore, based on the Secretary’s 

authority under section 1102 of the Act 

to establish requirements necessary for 

the efficient administration of the 

Medicare program, as well as the PHS 

Act requirement at section 371(b)(3)(I) 

for OPOs to ‘‘cooperate’’ with tissue 

banks to ensure all usable tissues are 

obtained, we are proposing 

requirements to ensure that OPOs 

maintain collaborative relationships 

with the tissue banks in their service 

areas. We believe the requirements we 

propose would serve to promote 

cooperation on the part of OPOs. 

We propose to strengthen the current 

requirement for OPOs to cooperate with 

tissue banks in the retrieval, processing, 

preservation, storage, and distribution of 

tissues, as may be appropriate, to ensure 

that all usable tissues are obtained from 

potential donors. We propose requiring 

OPOs to have arrangements with tissue 

banks that have agreements with 

hospitals and critical access hospitals 

with which the OPO has agreements to 

cooperate in the following activities, as 

may be appropriate, to assure that all 

usable tissues are obtained from 

potential donors: 

(1) Screening and referral of potential 

tissue donors; 

(2) Obtaining informed consent from 

families of potential tissue donors in the 

absence of a donor document; and 

(3) The retrieval, processing, 

preservation, storage, and distribution of 

tissues. 

An OPO would not be required to 

have an arrangement with a tissue bank 

unwilling to have an arrangement with 

the OPO. In such a situation, we would 

not consider the OPO to be out of 

compliance with the requirement. 

It should be noted here that the goal 

of the Secretary’s Donation Initiative is 

to increase all types of donation, 

including tissue, marrow, and blood 

donation. Therefore, although the 

purpose of this proposed rule is to 

increase organ donation, the Secretary 

has an interest in ensuring that OPOs 

act responsibly and collaboratively to 

further tissue donation in the United 

States. 

Condition: Administration and 

Governing Body (§ 486.324) 

[If you choose to comment on this 

section, please include the caption 

‘‘Administration and governing body’’ at 

the beginning of your comments.] 

In the current regulations, 

requirements for OPO boards are found 

at § 486.306, which lists qualifications 

to be designated by us as an OPO. We 

propose creating a separate section for 

administration and governing body, 

which would contain the proposed 

requirements for membership 

composition and bylaws of OPO boards, 

as well as requirements for the 

governing body that would have legal 

authority and responsibility for the 

management and provision of OPO 

services. 

Section 371(b)(1)(G) of the PHS Act 

(42 U.S.C. 273(b)(1)(G)) stipulates that a 

qualified OPO must have a board of 

directors or an advisory board that is 

composed of: 

• Members who represent hospital 

administrators, intensive care or 

emergency room personnel, tissue 

banks, and voluntary health associations 

in its service area; 

• Members who represent the public 

residing in such area,

• A physician with knowledge, 

experience, or skill in the field of 

histocompatibility; 

• A physician with knowledge or 

skill in the field of neurology; and 

• A surgeon from each transplant 

center in the OPO’s service area with 

which the OPO has arrangements to 

coordinate its activities. (The surgeon 

must have practicing privileges in the 

represented transplant center and 

perform organ transplant surgery). 

In addition, the PHS Act states the 

board has the authority to recommend 

policies for the procurement of organs 

and other functions (which are 

described below) and has no authority 

over any other activity of the OPO. 

The current regulations at § 486.306(f) 

require an OPO to have a board of 

directors or an advisory board. An OPO 

may have more than one board, but at 

least one board must be responsible for 

recommending policies relating to the 

donation, procurement, and distribution 

of organs and include the specific 

membership composition required by 

the PHS Act. (See section 371(b)(1)(H) 

(42 U.S.C 273(b)(1)(H).) 

We are proposing a similar 

requirement, in that an OPO may have 

as many individual boards as it chooses, 

but one of its boards must have the 

specific membership composition 

prescribed by the PHS Act and must 

operate under restraints similar to those 

prescribed by the PHS Act for that 

board. That is, the board would be 

limited to recommending policies 

relating to the donation, procurement, 

and distribution of organs, would serve 

6104 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

only in an advisory capacity, and could 

not also serve as the OPO’s board of 

directors. For purposes of discussion in 

this preamble, we refer to this board as 

an advisory board. To ensure that the 

board’s members remain in an advisory 

capacity as stipulated by the PHS Act, 

we propose that the board’s members 

would be prohibited from serving on 

any other OPO board. We also would 

require OPOs to have bylaws for each of 

its boards to address potential conflicts 

of interest, length of terms, and criteria 

for selection and removal of members. 

Note that there appears to be a crossreference problem in the PHS Act 

related to the recommendations of the 

advisory board. The statute provides 

that the advisory board ‘‘has the 

authority to recommend policies for the 

procurement of organs and other 

functions described in (2). (See 42 U.S.C 

273(b)(1)(H)(ii).) Currently, section 

371(b)(2) is directed to the Secretary and 

concerns rulemaking. It does not speak 

to policies where an advisory board’s 

recommendations would be relevant for 

an OPO. We believe it is likely that 

Congress intended that the OPO obtain 

the recommendations of the advisory 

board on the functions that an OPO is 

required to perform and that are listed 

in section 273(b)(3). We are proposing 

that the advisory board make 

recommendations to the OPOs on the 

subjects discussed in section 273(b)(3) 

and that are specifically listed in 

proposed § 486.324(b) through (11). 

Even if there were not a cross-reference 

problem, we would propose that the 

advisory board make recommendations 

to the OPO on the topics identified in 

our proposed rules based on our 

authority at 42 U.S.C. 1102. The 

expertise of the board would provide a 

useful perspective on those issues, and 

the advisory board’s recommendations 

would likely lead to more efficient and 

effective actions by the OPO in 

procuring organs, as well as better 

coordination with various business 

partners. 

We propose including in the 

condition for administration and 

governing body, certain language from 

the PHS Act that specifies the types of 

policies this advisory board can 

recommend. We believe that it is worth 

restating these specific provisions, both 

because the philosophy behind them is 

important and because we do not 

believe all OPOs and OPO board 

members are aware of them.

The single OPO advisory board whose 

membership composition is mandated 

by the Act has the authority to 

recommend policies for the 

procurement of organs and other 

functions including: (1) Effective 

agreements to identify potential organ 

donors with a substantial majority of 

hospitals in its service area that have 

facilities for organ donation; (2) 

systematic efforts, including 

professional education, to acquire all 

usable organs from potential donors; (3) 

arrangements for the acquisition and 

preservation of donated organs and 

provision of quality standards for the 

acquisition of organs that are consistent 

with the standards adopted by the 

OPTN, including arranging for testing 

with respect to preventing the 

acquisition of organs that are infected 

with the etiologic agent for acquired 

immune deficiency syndrome; 

appropriate tissue typing of organs; a 

system for allocation of organs among 

transplant patients according to 

established medical criteria; 

transportation of organs to transplant 

hospitals; coordination of activities with 

transplant hospitals in the OPO’s 

service area; participation in the OPTN; 

arrangements to cooperate with tissue 

banks for the retrieval, processing, 

preservation, storage, and distribution of 

tissues as may be appropriate to ensure 

that all usable tissues are obtained from 

potential donors; annual evaluation of 

the effectiveness of the OPO in 

acquiring organs; and assistance to 

hospitals in establishing and 

implementing protocols for making 

routine inquiries about organ donations 

by potential donors. The PHS Act states 

that the OPO board ‘‘has no authority 

over any other activity of the 

organization.’’ (See section 

371(b)(1)(H)(iii) of the PHS Act (42 

U.S.C. 273(b)(1)(H)(iii).) 

It has come to our attention that some 

OPO boards with the membership 

composition stipulated by the PHS Act 

may do more than recommend policies. 

This is a matter of concern because 

some OPOs have told us that their 

boards prevent them from taking steps 

to adopt best practices because of the 

costs involved (for example, by refusing 

to approve the hiring of additional staff 

or implementation of protocols to 

provide better management of potential 

donors). Board members may be 

motivated by a desire to keep standard 

organ acquisition fees low for the 

transplant hospitals in their OPO’s 

service area; however, the result may be 

that organ donation rates remain low as 

well. We would note that some OPOs 

have taken steps to address what they 

regard as the conflict of interest created 

by having a board heavily weighted 

with representatives of transplant 

centers. For example, New England 

Organ Bank (one of the high-performing 

OPOs studied in the Organ Donation 

Breakthrough Collaborative) has 

balanced the representation on its board 

by adding members to its board who 

represent other hospitals and 

community interests. Donor alliance, 

another OPO studied by the 

Collaborative, has a 25-member 

community-based board that has 

‘‘allowed considerable latitude for 

innovation and risk-taking.’’

By incorporating this language into 

our proposed regulations for OPOs, we 

are reminding OPOs and their boards 

that under the PHS Act, the OPO board 

whose membership composition is 

outlined in the PHS Act has specific 

limits placed on its authority. 

Note that our proposed language 

differs from that of the PHS Act in some 

respects. Instead of ‘‘a system for 

allocating organs according to 

established medical criteria’’ we 

propose referencing ‘‘a system for 

allocating organs according to the rules 

and requirements of the OPTN,’’

because the OPTN establishes the 

medical criteria used to allocate organs 

among transplant patients. (The term 

‘‘rules and requirements of the OPTN’’

means those rules and requirements 

approved as enforceable by the 

Secretary.) 

Both the PHS Act and the existing 

regulations require an OPO to have a 

tissue bank representative on its board. 

We propose requiring an OPO to have 

on its advisory board a tissue bank 

representative from a facility not 

affiliated with the OPO, unless the only 

tissue bank in the service area is 

affiliated with the OPO. (In other words, 

if the OPO operates a tissue bank, the 

OPO must include an independent 

tissue bank on the board that represents 

all independent tissue banks in the 

OPO’s service area, unless there are no 

independent tissue banks in the OPO’s 

service area.) These requirements 

presume that tissue bank representatives 

with these qualifications exist in an 

OPO’s service area and would be willing 

to serve on the OPO’s advisory board. If 

not, the OPO would not be considered 

out of compliance with this 

requirement. 

Because of the ‘‘gatekeeper’’ role of 

OPOs in regard to potential tissue 

donors, we believe it is important for 

OPO boards to include representatives 

from tissue banks that are not affiliated 

with the OPO (unless, of course, the 

OPO has the only tissue bank in the 

service area) to ensure that tissue banks 

have some voice in the OPO policies 

that affect them and to encourage OPOs 

and tissue banks to work together on 

issues that affect both organizations.

Although the PHS Act specifies that 

hospital administrators must be 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6105

represented on an OPO’s board of 

directors or advisory board, it does not 

specify whether donor or transplant 

hospital administrators should be 

represented. Since transplant hospitals 

are already well represented by the 

many transplant surgeons who serve on 

OPO boards, we strongly urge (but 

would not require) OPOs to include 

administrators from donor hospitals to 

provide input and foster collaboration 

between OPOs and their donor 

hospitals. 

We have received suggestions that we 

require OPOs to include representatives 

from research facilities, donor family 

members, transplant recipients, 

coroners or medical examiners, social 

workers, and chaplains on their 

advisory boards. Although these are 

worthy suggestions, we are reluctant to 

require OPO advisory boards to 

accommodate all these interests, lest 

they become too large to operate 

effectively. Additionally, many OPOs 

already include some of these 

individuals on their boards to fulfill the 

requirement for members representing 

the public. Therefore, we are requesting 

comments on the advisability of 

requiring OPO boards to have those 

representatives. 

Note that, for clarification purposes, 

we are proposing to change the current 

requirement for an OPO to have a 

transplant surgeon from each transplant 

center on its board to a requirement for 

an OPO to have a transplant surgeon 

from each transplant hospital on its 

advisory board. Although ‘‘transplant 

hospital’’ and ‘‘transplant center’’ are 

often used interchangeably, the term 

‘‘transplant center’’ sometimes is used 

to refer to an individual transplant 

program (such as a heart transplant 

program or liver transplant program) 

within a hospital that performs 

transplants. Since some OPOs have 

more than a dozen transplant hospitals 

in their service areas, a requirement to 

have a transplant surgeon from each 

program within each hospital would 

lead to OPO advisory boards with an 

overwhelming number of members. 

Therefore, we believe it is advisable to 

change the language to clarify that even 

if a hospital has multiple transplant 

programs, the OPO need have only one 

transplant surgeon per transplant 

hospital or hospital system. 

In addition, we propose requiring that 

the transplant surgeon who serves on 

the OPO board must have practicing 

privileges and perform transplants in 

the hospital he or she represents. This 

requirement would ensure the surgeon 

has a thorough knowledge of the needs 

of the transplant hospital and can 

represent the hospital or hospital system 

adequately. 

When selecting transplant surgeons 

for their advisory boards, OPOs should 

strive for representation of all organ 

types. That is, if an OPO’s service area 

includes heart, liver, lung, pancreas, 

and kidney transplant programs, the 

OPO should include a surgeon who 

performs each type of transplant. 

We are proposing to require that 

OPOs have a governing body (for 

example, a board of directors) that has 

full legal authority and responsibility 

for the management and provision of all 

services. We believe it is important for 

efficient operation of an OPO for 

authority to reside in a single body. The 

governing body would be responsible 

for developing and overseeing 

implementation of policies and 

procedures necessary for effective 

administration of the OPO, including 

fiscal operations, a QAPI program, and 

services furnished under contract or 

arrangement, including agreements for 

these services. We would require an 

OPO to have a procedure to address 

potential conflicts of interest for the 

governing body. In addition, we would 

require the governing body to appoint 

an individual to be responsible for dayto-day operation of the OPO. We are 

requesting public comment regarding 

the proposed requirement for a 

governing body, specifically, whether it 

would be appropriate for the legal 

authority and responsibility for the 

management and provision of all OPO 

services to lie with an individual, rather 

than a governing body.

We believe the requirements we 

propose would provide flexibility so 

that each OPO would be free to choose 

the most efficient and effective form of 

administration and governance to suit 

its own needs and to fulfill its mission 

of maximizing organ donation. 

Condition: Human Resources (Proposed 

§ 486.326) 

[If you choose to comment on this 

section, please include the caption 

‘‘Human resources’’ at the beginning of 

your comments.] 

The current regulations at § 486.306(e) 

require an OPO to have ‘‘a director and 

such other staff, including an organ 

donation coordinator and an organ 

procurement specialist, necessary to 

obtain organs effectively from donors in 

its service area.’’ There are no additional 

human resources requirements in the 

current regulations. 

We do not believe this single 

requirement is adequate to ensure that 

each OPO has a sufficient number of 

staff members with the proper skills to 

provide necessary services and to 

maximize recovery of healthy organs for 

transplantation. Furthermore, both 

research studies (which are cited 

throughout our discussion of proposed 

§ 486.326) and the experiences of our 

OPO Coordinators provide evidence that 

having a sufficient number of trained 

and qualified staff is positively 

associated with good outcomes, such as 

increases in organ donation. We also 

note that one of the best practices 

identified by the Organ Donation 

Breakthrough Collaborative is to ‘‘strive 

to recruit and retain highly motivated 

and skilled staff.’’

Thus, we are proposing human 

resources requirements that we believe 

are essential to the functioning of all 

OPOs. We propose that an OPO would 

be required to have a sufficient number 

of qualified staff to ensure that all 

usable organs are recovered and to 

provide all required services to the 

families of potential donors, hospitals, 

tissue banks, and individuals and 

facilities that use organs for research. 

OPOs would be required to ensure 

that all individuals who provide or 

supervise services, including services 

provided under contract or arrangement, 

are qualified to perform these duties.

In addition, we would require every 

OPO to develop and implement a 

written policy to address potential 

conflicts of interest for the OPO’s 

director, medical director, senior 

management, and procurement 

coordinators. In 2002, we cited a Florida 

OPO whose procurement director 

owned a company that purchased 

organs from the OPO and sold them for 

research—a serious conflict of interest 

that led to the dismissal of OPO 

officials. We believe an OPO’s conflictof-interest policy should clearly 

delineate and prohibit those outside 

activities or affiliations that have the 

potential to impact an employee’s 

ability to make impartial decisions that 

are in the best interests of both the OPO 

itself and the organ procurement and 

transplantation system in the United 

States. 

Although the Medicare hospital 

regulations require hospitals to review 

credentials and grant clinical privileges 

to medical staff, it is difficult, if not 

impossible, for a donor hospital to 

credential and grant privileges to 

recovery surgeons and other members of 

recovery teams who are not members of 

the hospital’s medical staff. Recovery 

surgeons and other recovery team 

members may recover organs in a 

particular donor hospital no more than 

once in a period of several years. Thus, 

their work is too limited to undergo 

effective review by the donor hospital 

for the granting of clinical privileges. 

6106 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

However, it is imperative that someone 

ensure recovery personnel are qualified 

to recover organs in a manner that 

preserves their viability for 

transplantation. 

Therefore, we propose requiring OPOs 

to maintain credentialing records for 

physicians and other practitioners who 

routinely recover organs in hospitals 

under contract or arrangement with the 

OPO (for example, transplant surgeons 

from local transplant hospitals who 

frequently recover organs in the OPO’s 

donor hospitals). In addition, we 

propose requiring OPOs to ensure that 

all physicians and other practitioners 

who recover organs in hospitals with 

which the OPO has agreements are 

qualified and trained. Note that we are 

not proposing a requirement for an OPO 

to maintain credentialing records for 

physicians and other practitioners if 

they do not routinely recover organs 

under contract or arrangement with the 

OPO (for example a transplant surgeon 

from a hospital outside the OPO’s 

service area). In those circumstances, 

the OPO would be required only to 

verify that the transplant surgeon was 

qualified and trained. This could be 

accomplished by, for example, 

contacting the transplant hospital to 

confirm that the surgeon who will be 

recovering an organ at one of the OPO’s 

hospitals is credentialed and has 

privileges at the transplant hospital. 

Studies provide empirical evidence 

that sufficient staffing serves to 

maximize organ donation. For example, 

in a report on 12 years of experience at 

LifeGift Organ Donation Center in 

Texas, the report’s authors commented 

that LifeGift’s staff resources were 

‘‘critical to its ability to sustain and 

increase donation.’’ They noted that 

LifeGift in the 7-year period preceding 

publication of the report had an 80 

percent growth in staff and a 61 percent 

increase in organ donors. (T. Shafer, C 

Van Buren, C Andrews; Program 

Development and Routine Notification 

in a Large Independent OPO: A 12-year 

Review, Journal of Transplant 

Coordination, Vol. 9, No. 1, March, 

1999.) 

A recent report on OPO best practices 

listed ‘‘timely, on-site response to 

potential donor referrals’’ as a key 

attribute of a successful OPO. 

(Preliminary results of a best practices 

study presented at tri-annual meeting of 

the South-Eastern Organ Procurement 

Foundation on September 14, 2000 by 

R. Randal Bollinger, MD, Ph.D. Chief of 

the Division of General Surgery, Duke 

University Medical Center. In addition 

to Dr. Bollinger, other study authors 

include Dennis Heinrichs, MBA, 

President, LifeLink Foundation; and 

United Network for Organ Sharing 

(UNOS) staff members.) (Note that 

UNOS is the organization under 

contract with the Health Resources and 

Services Administration to operate the 

OPTN.)

The report on LifeGift’s 12-year 

experience noted that ‘‘adequate, even 

‘deep’ staffing levels allowed the OPO to 

respond in person within one hour of 

referral on every potential organ donor 

case.’’ We do not propose mandating a 

1-hour time frame because geographical 

and other differences in OPO service 

areas could make such a short time 

frame impossible to meet. Furthermore, 

some hospitals contact their OPOs very 

early in the donation process, which 

means it may not be necessary for OPO 

staff to arrive at the hospital within 1 

hour. Clearly the ideal time frame is one 

in which the OPO arrives at the hospital 

early enough to ensure that all steps in 

the donation process can take place, and 

the desired outcome is the recovery of 

healthy organs. 

Therefore, we propose requiring the 

OPO to provide sufficient coverage, 

either by its own staff or under contract 

or arrangement, to screen hospital 

referral calls for organ donor potential 

and evaluate potential donors for 

medical suitability for organ donation in 

a timely manner. This means that once 

an OPO receives timely notification 

from a hospital about a patient who 

appears likely to be medically suitable 

for organ donation, the OPO must 

perform an assessment of the patient’s 

medical suitability for organ donation 

early enough in the donation process so 

that there is sufficient time to discuss 

donation with the family of the 

potential donor, implement 

management protocols for the potential 

donor, place the organs for 

transplantation, and arrange for 

recovery and transportation of the 

organs while they are still viable. 

In addition, we propose requiring an 

OPO to have a sufficient number of 

qualified staff to provide information 

and support to potential organ donor 

families; request consent for donation; 

ensure optimal maintenance of donors, 

efficient placement of organs, and 

adequate oversight of organ recovery; 

and conduct QAPI activities, such as 

death record reviews and hospital 

development. We are not proposing 

specific staffing levels because we 

believe each OPO must determine the 

amount of staff it needs to ensure that 

families of potential donors are treated 

with sensitivity and respect and that the 

maximum number of viable organs are 

procured and provided to hospitals for 

transplantation.

However, we can provide guidance to 

OPOs so that they can determine if the 

number of staff they have would be 

‘‘sufficient’’ under the proposed 

regulation. The determination is based 

primarily on outcomes, not just the 

ultimate outcome—procuring a healthy 

organ for transplantation—but the 

intermediate steps that lead to the 

procurement (such as assessing the 

potential donor and obtaining consent), 

as well as those critical activities that 

support and surround the actual 

donation process (such as hospital 

development and death record reviews). 

An OPO should analyze the flow of 

the donation process in each of its 

hospitals, and determine whether the 

flow is impeded at any point by a lack 

of staff. Does the OPO have enough staff 

available at all times to: Assess potential 

donors promptly; spend as much time 

as necessary with the family to answer 

questions and provide support and 

counseling; manage the potential donor 

optimally; maximize the number of 

organs placed for transplantation; and 

recover (or arrange for the recovery of) 

organs as quickly as possible? 

An OPO should scrutinize its QAPI 

program and determine whether 

additional staff would enable the OPO 

to broaden the scope of its QAPI 

program and lead to improved 

performance. Does the OPO have 

sufficient staff to monitor and evaluate 

all donation services; recommend steps 

to improve performance; track 

performance over time; and perform 

death record reviews at Medicare and 

Medicaid hospitals that have a level I or 

level II trauma center or 150 or more 

beds (with the exception of psychiatric 

and rehabilitation hospitals)? 

An OPO also should look closely at 

hospital development staffing because 

effective hospital development creates a 

culture that supports and promotes 

donation. Does the OPO have sufficient 

staff to make its presence felt in 

hospitals (particularly those hospitals 

with high donation potential) by: 

Developing a relationship with 

emergency department and intensive 

care unit staff; providing ongoing 

education for hospital staff; meeting 

with hospital leaders and key 

physicians to gain their support for 

organ donation; providing donation data 

and encouraging hospitals to use the 

data in quality improvement activities? 

As stated earlier, we do not propose 

to establish specific staffing levels 

because OPOs must have the flexibility 

to determine their own staffing needs. 

However, OPOs rightfully will be 

concerned about how such an imprecise 

requirement would be enforced. 

Certainly we understand that for reasons 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6107

beyond their control, OPOs (like all 

other businesses) sometimes will not 

have enough staff. We would not cite an 

OPO for having insufficient staff if the 

insufficiency is temporary or occasional 

or if the OPO clearly is doing its best to 

keep staffing at an optimal level. The 

requirement is intended to give 

surveyors the option of citing an OPO 

when there is a pattern of chronic 

understaffing in critical areas, and the 

OPO has not taken the appropriate steps 

to improve the situation (for example, if 

the board of directors consistently has 

refused to approve funds for additional 

staff needed to improve the OPO’s 

performance). 

The OPTN/UNOS Council for Organ 

Availability Requestor Project studied 

organ donation requestors who have the 

greatest success in getting families to 

consent to organ donation. Results of 

the study suggest that the experience of 

procurement coordinators is positively 

associated with increased consent rates; 

the average ‘‘expert requestor’’ has 4 

years of experience. The LifeGift report 

notes that adequate staffing results in a 

staff that is not ‘‘spread too thin.’’ The 

report also notes that adequate staffing 

allows, when appropriate, assigning two 

coordinators to one donor case, which 

may improve organ yield by allowing 

one coordinator to focus on donor 

management while another focuses on 

organ placement. We believe that 

adequate staffing by OPOs avoids staff 

burn out and frequent turnover of organ 

procurement coordinators, which is a 

significant problem for many OPOs.

A recent study published in the 

Journal of the American Medical 

Association on factors that influence 

family consent noted, ‘‘Our data 

strongly indicated that involvement of 

the family with a professional from the 

OPO is critical. The time spent with the 

OPO coordinator was a strong factor 

associated with the decision to donate.’’

(Siminoff, L, Gordon, N, Hewlett, J, 

Arnold, R. Factors Influencing Families’

Consent for Donation of Solid Organs 

for Transplantation. Journal of the 

American Medical Association. 2001; 

286:71–77.) It is clear that adequate 

staffing can ensure that procurement 

coordinators have ample time to spend 

with donor families. (Note that in citing 

this study, we are not suggesting that 

hospital designated requestors should 

not be involved in the donation process. 

Studies show that involvement of 

hospital staff with the OPO in 

requesting consent leads to the highest 

consent rates.) 

Finally, we propose requiring an OPO 

to provide a sufficient number of 

recovery personnel, either from its own 

staff or under contract or arrangement, 

to ensure that all usable organs are 

recovered in a manner that, to the extent 

possible, preserves them for 

transplantation. This proposal is based 

on our OPO Coordinators’ knowledge of 

situations in which organs were not 

recovered from medically suitable 

potential because local surgeons or 

other recovery personnel were not 

available. Some OPOs prevent these 

situations by hiring their own recovery 

personnel. For example, one of the highperforming OPOs studied in the Organ 

Donation Breakthrough Collaborative, 

Donor Alliance, has circumvented this 

problem by hiring ‘‘organ recovery 

specialists’’ with extensive training and 

experience in organ recovery. 

The current OPO regulations have no 

requirements for an OPO’s management 

of its human resources. We believe that 

prudent management of human 

resources, including provision of 

sufficient education, training, 

supervision and evaluation, is a 

fundamental necessity if OPOs are to 

have expert, highly qualified staff who 

can maximize organ donation. Ongoing 

staff training is a necessity at all OPOs 

in order to maintain staff skill sets and 

keep up with rapid advances in 

procurement and transplantation. 

However, we have found that a few 

OPOs do not provide these services for 

their staffs, which leads to confusion 

about roles and responsibilities, suboptimal staff functioning, and resultant 

poor OPO performance. Conversely, our 

OPO Coordinators have noted lower 

staff turnover among OPOs that provide 

education and training and clearly 

define their staffs’ roles and 

responsibilities. 

Therefore, we propose requiring OPOs 

to provide their staffs with the 

education, training, and supervision 

necessary to furnish required services. 

Training must include, but is not 

limited to, performance expectations for 

staff, applicable organizational policies 

and procedures, and QAPI activities. In 

addition, OPOs must evaluate the 

performance of their staff and provide 

training, as needed, to improve 

individual and overall staff performance 

and effectiveness. For example, staff 

who make donation requests can be 

evaluated by their consent rates; staff 

who clinically manage donors can be 

evaluated by how many organs are 

recovered and transplanted from donors 

and whether immediate organ function 

occurs in the recipient; and hospital 

development staff can be evaluated by 

the percentage of cases in which timely 

donation notifications are made and 

how often donation requests are 

conducted collaboratively between OPO 

and hospital. An OPO can utilize this 

information to inform the development 

of training, tailor their training to the 

needs of their staffs, and identify 

individual staff who require additional 

training.

We believe in-depth training for 

procurement coordinators is particularly 

critical because procurement 

coordinators serve on the OPO front 

lines. They provide counseling to 

grieving families, explain donation 

options, make the request for donation, 

oversee recovery of organs, and package 

organs for transport to transplant 

hospitals. One of a procurement 

coordinator’s most critical functions is 

management of potential donors to 

maintain the viability of their organs, 

which is a highly complex and 

demanding task. Nevertheless, some 

procurement coordinators have told us 

their OPOs do not provide sufficient 

training and supervision for new 

procurement coordinators, even though 

inexperienced coordinators run the risk 

of making errors that can lead to denial 

of consent or the loss of a donor. 

Therefore, in an effort to decrease 

errors and provide support to the 

inexperienced coordinator, we are 

requesting comments on the advisability 

of including a requirement in the final 

rule for supervision of an inexperienced 

procurement coordinator by an 

experienced procurement coordinator, 

director of procurement, medical 

director, or other experienced 

individual during the consent process 

and during management of all donor 

cases. In addition, we are requesting 

comments on whether experience 

should be defined by length of service 

or number of donation cases, what 

experience thresholds would be 

appropriate, and how long an 

inexperienced procurement coordinator 

would need supervision. 

We acknowledge that it can be 

difficult for OPOs to hire and retain staff 

with the necessary qualifications, 

experience, and dedication to fill 

critical staff positions, particularly 

procurement coordinator positions, and 

to provide their staffs with education 

and training. Many OPOs find high staff 

turnover to be a significant barrier to 

increasing organ donation in their 

service areas. Nevertheless, many OPOs 

are able to recruit and retain qualified 

staff by providing training, 

opportunities for growth, and a 

supportive atmosphere that encourages 

independence and innovation. It is clear 

that the six OPOs whose practices were 

studied as part of HRSA’s Breakthrough 

Collaborative would all agree that 

professional, committed, and 

experienced staff have formed the basis 

for their success. One of the OPOs, New 

6108 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

England Organ Bank, emphasizes that 

its devoted staff and low staff turnover 

are contributing factors to its high 

performance. 

The Collaborative’s Best Practices 

Final Report identified five strategies 

OPOs can use to recruit and retain 

skilled and motivated staff. 

The first strategy is to use various 

practices to identify and recruit staff. 

For example, according to the study 

report, LifeLink of Florida uses an 

extensive ‘‘reality’’ interview process in 

which candidates meet with staff and 

participate in actual organ referral and 

donation events. This process enables 

LifeLink to hire staff who are 

‘‘aggressive, collaborative, assertive, and 

able to work under stressful 

conditions.’’

The second strategy is to offer 

adequate orientation and training. One 

of the six high-performing OPOs, New 

England Organ Bank, puts newly-hired 

staff through a formal training program 

‘‘tailored to their specialized function.’’

The third strategy is to create a 

culture of collaboration and autonomy. 

Every high-performing OPO studied 

pointed to strong collaborative 

relationships as a factor that contributes 

to their success. These OPOs have 

forged successful relationships both 

within their own staffs and with outside 

organizations and other parties in the 

donation process, such as tissue banks, 

hospital administrators, physicians, and 

nurses.

Perhaps the best example of 

collaboration is the in-house 

coordinator (IHC) program developed by 

LifeGift Organ Donation Center in 

Houston, which places two full-time 

nurses in all Level I trauma centers. 

According to the study, the OPO staff 

are ‘‘fully integrated into hospital 

operations,’’ which promotes ‘‘strong, 

transparent hospital partnerships.’’

The fourth strategy discussed in the 

study is to offer flexible work 

environments and other benefits. At 

Mid-America Transplant Services in St. 

Louis, OPO staff are given specialized 

roles in the donation process based on 

their professional experience. Staff have 

the flexibility to work from home and 

are given financial incentives when they 

meet performance targets. 

The fifth strategy noted in the study 

is to provide opportunities for 

professional growth and development. 

The Report’s authors provide many 

examples of the opportunities that the 

high-performing OPOs provide to their 

staffs. For example, since most ‘‘family 

support coordinators’’ at Donor alliance 

have non-clinical backgrounds, the OPO 

provides extensive training in the 

medical suitability of organ donors. In 

another example, Mid-America’s two 

operating rooms are used to give their 

clinical staff an opportunity to learn 

new skills and develop professionally. 

We urge all OPOs to read the report 

of the Collaborative, titled, ‘‘The Organ 

Donation Breakthrough Collaborative: 

Best Practices Final Report,’’ which is 

available on the Department’s Web site 

at http://www.organdonor.gov.

Voluntary OPTN bylaws call for OPOs 

to have a medical director who is a 

licensed physician and is responsible 

for the medical and clinical activities of 

the OPO. Although current regulations 

do not require OPOs to have a medical 

director, most OPOs employ a medical 

director as part of their management 

staff and recognize the value and 

expertise this position brings to their 

OPO programs. Our OPO Coordinators 

have found that most high-performing 

OPOs have active, involved medical 

directors. Therefore, we propose 

requiring an OPO to have a medical 

director who would be responsible for 

implementation of protocols for donor 

evaluation and management and organ 

placement and recovery. 

The medical director would be 

responsible for oversight of the clinical 

management of donation cases, 

including providing assistance in the 

medical management of a donor case 

when the surgeon on call is unavailable. 

We would expect that in meeting these 

requirements, OPOs would have 

medical directors who oversee clinical 

donation processes, facilitate best 

practices, and provide guidance for OPO 

staff, both clinical and non-clinical, 

about all clinical donation issues. 

We believe the human resources 

requirements we propose would ensure 

efficient and effective operation of 

OPOs, which is in the best interests of 

the organ donation and transplantation 

system. In addition, the requirements 

would further the efficient 

administration of the Medicare program. 

As we stated earlier, section 1102 of the 

Act grants the Secretary the authority to 

establish requirements necessary for the 

efficient administration of the Medicare 

program. 

Condition: Reporting of Data (Proposed 

§ 486.328) 

[If you choose to comment on this 

section, please include the caption 

‘‘Reporting Data’’ at the beginning of 

your comments.] 

The current regulations (§ 486.310) 

require an OPO to submit data to us 

annually showing the number of donors, 

the number of kidneys and extra-renal 

organs procured, and the number of 

kidneys and extra-renal organs 

transplanted so that we can determine 

whether the OPO has met the 

performance requirements. We propose 

broadening this requirement to require 

OPOs to provide individuallyidentifiable, hospital-specific organ 

donation and transplantation data to the 

OPTN and the Scientific Registry of 

Transplant Recipients (SRTR), as 

directed by the Secretary. (Note that at 

present the SRTR does not collect data; 

its current mandate is to analyze data 

collected by the OPTN.) We also 

propose requiring OPOs to provide 

hospital-specific organ donation data to 

transplant hospitals, annually. Finally, 

we propose requiring OPOs to report 

individually-identifiable, hospitalspecific organ donation and 

transplantation data and other 

information to the Department, as 

requested by the Secretary. 

Data could include, but would not be 

limited to, (1) The number of hospital 

deaths; (2) results of death record 

reviews; (3) number and timeliness of 

referral calls from hospitals; (4) 

potential donor denominator (as defined 

in § 486.302); (5) data related to nonrecovery of organs, (6) data about 

consents for donation; (7) number of 

donors; (8) number of organs recovered 

(by type of organ); and (9) number of 

organs transplanted (by type of organ). 

We would note that OPOs are 

specifically exempted from regulatory 

requirements for the privacy of 

individually identifiable health care 

information under the Health Insurance 

Portability and Accountability Act. 

Regulations at 45 CFR 164.512(h) state, 

‘‘A covered entity may use or disclose 

protected health care information to 

organ procurement organizations or 

other entities engaged in the 

procurement, banking, or 

transplantation of cadaveric organs, 

eyes, or tissue for the purpose of 

facilitating organ, eye, or tissue 

donation and transplantation.’’

Our reasons for proposing this 

requirement are three-fold. First, it 

would bring data reporting requirements 

for OPOs into agreement with those for 

transplant hospitals. Hospital 

regulations at 42 CFR 482.45(b)(3) 

require transplant hospitals to provide 

organ-transplant-related data as 

requested by the OPTN, the SRTR, and 

the OPOs. Transplant hospitals must 

also provide those data directly to the 

Department when requested by the 

Secretary. Ensuring a flow of data 

between transplant hospitals and OPOs 

promotes collaboration and can enable 

transplant hospitals to improve their 

programs. For example, a transplant 

hospital can use data from OPOs in its 

QAPI program, such as data that allow 

it to compare its transplantation rates 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6109

with those of other transplant hospitals 

in the OPO’s service area or data 

showing how many times and for what 

reasons the hospital’s own transplant 

programs have turned down organ offers 

from the OPO. 

Second, CMS Regional Office OPO 

Coordinators need data from OPOs to 

target areas for improvement both in 

OPOs and hospitals, and third, the OIG 

has recommended CMS use hospitalspecific data provided by OPOs to 

monitor the impact of the hospital CoP 

and improve hospital compliance with 

the CoP. In short, we believe these data 

reporting requirements for OPOs are 

necessary for the efficient 

administration of the Medicare program 

and can be required based on the 

Secretary’s authority under section 1102 

of the Act. 

We would note that most OPO data 

needed by us or other agencies within 

the Department can be obtained from 

the OPTN or the SRTR. In fact 42 CFR 

121.11(b)(2) requires OPOs and 

transplant hospitals to submit 

information about tranplant candidates, 

transplant recipients, organ donors, 

transplant program costs and 

performance, and ‘‘other information 

that the Secretary deems appropriate.’’

We would not request data from OPOs 

if the data were readily available from 

other sources. We are including this 

provision only to give us and other 

entities the flexibility to request data 

from OPOs if data cannot be obtained 

expeditiously from other sources. The 

Secretary would use such data and other 

information for monitoring of hospital 

compliance with the CoP, monitoring of 

OPO compliance with the process 

performance measures and other 

requirements, and assisting OPOs with 

their QAPI programs. 

We propose including language that 

defines how OPOs should report data 

for donors and organs procured and 

transplanted to ensure that all OPOs are 

following the same reporting protocol. A 

uniform process would ensure accurate 

reporting and will enable us to make a 

true comparison of the OPOs’

performance. We propose including 

reporting protocols for the following: 

‘‘kidneys procured,’’ ‘‘kidneys 

transplanted,’’ extra-renal organs 

procured,’’ and ‘‘extra-renal organs 

transplanted.’’ For example, under 

‘‘kidneys procured,’’ en bloc kidneys are 

counted as two kidneys procured. 

Under ‘‘extra-renal organs procured,’’ a 

heart and two lungs recovered from one 

donor would count as three organs 

procured. 

In August 2000, the Office of the 

Inspector General (OIG) for the 

Department of Health and Human 

Services released a report on the CoP 

titled, ‘‘Medicare Conditions of 

Participation for Organ Donation: An 

Early Assessment of the New Donation 

Rule.’’ The OIG found that OPOs and 

hospitals had not yet taken full 

advantage of the CoP. The OIG noted, 

‘‘Maximizing organ donation requires 

coordination and collaboration between 

hospitals and OPOs. The donation rule, 

however, is contained in the Medicare 

conditions of participation for hospitals. 

While it provides OPOs with significant 

leverage that they can use to work with 

hospitals on donation, the rule places 

the obligation for compliance solely on 

hospitals; it sets no requirements for 

OPOs. Effective implementation of the 

donation rule requires accountability on 

behalf of both OPOs and hospitals.’’

The OIG recommended that to 

increase OPO accountability, we require 

OPOs to provide hospital-specific data 

on referrals and organ recovery. The 

OIG stated that obtaining data from 

OPOs would be the most effective and 

efficient way to monitor the CoP and 

assess hospital compliance because 

OPOs already collect the necessary data 

and have them readily available. The 

report states, ‘‘We believe that OPOs 

could reasonably, inexpensively, and 

easily provide current data on a 

quarterly basis.’’

We agree with the OIG’s conclusions. 

Although all OPOs collect hospitalspecific data on referrals and organs 

recovered, current regulations do not 

require OPOs to share these data with 

us, and OPOs have been reluctant to 

share data with us voluntarily lest they 

affect their collegial relationships with 

their hospitals. Therefore, we must rely 

on surveys performed by the Joint 

Commission on Accreditation of 

Healthcare Organizations (JCAHO) and 

State survey agencies to monitor 

hospital compliance. However, JCAHO 

surveys usually are performed only once 

every 3 years and State Medicare 

surveys are performed even less 

frequently. Moreover, requirements for 

organ, tissue, and eye procurement are 

only a small part of hospital 

accreditation and certification surveys, 

and surveying for those requirements 

may have a lower priority than 

surveying for requirements affecting 

direct patient care. In fact, the OIG 

noted that some hospitals reported to 

them that surveyors asked only to see 

their policies and procedures for organ 

donation and did not probe further to 

determine whether the hospital was 

complying with all requirements in the 

regulation. 

Based on the OIG’s recommendations, 

HRSA, CMS, and the Association for 

Organ Procurement Organizations 

(AOPO) determined what data should 

be reported to the OPTN (and, in turn, 

reported by the OPTN to HRSA and 

CMS). As stated earlier in this preamble, 

in September 2001, OPOs began 

reporting the following hospital-specific 

data electronically to the OPTN: (1) The 

number of referral calls received from 

hospitals; (2) the number of potential 

donors; and (3) the number of consents 

to donation. The OPTN calls for OPOs 

to report the number of donors and the 

number of organs recovered at each 

hospital. In the future, as data needs are 

identified (for example, the number of 

deaths in each hospital), the OPTN may 

begin collecting additional data. We can 

obtain data from the OPTN through 

HRSA at any time. OPOs currently 

report data to the OPTN within 30 days 

of the end of the month in which a 

death occurs, and we propose requiring 

that OPOs continue to report their data 

within this time frame. However, if an 

OPO determined through death record 

reviews or by other means that the data 

it reported to the OPTN was incorrect, 

we would require the OPO to report the 

corrected data to the OPTN within 30 

days of the end of the month in which 

the error was identified. 

The OIG report recommended that we 

require OPOs to make hospital-specific 

donation performance data publicly 

available in order to recognize hospitals 

that do a good job. They pointed out 

that one OPO in the nation already 

publishes organ donation data for every 

hospital in its service area. We agree 

that the efforts of hospitals that 

collaborate with their OPOs and support 

organ donation should be recognized. 

Publication of those data has the dual 

effect of recognizing the efforts of goodperforming hospitals, while holding 

hospitals more accountable for organ 

donation. In addition, as we note 

elsewhere in this preamble, if OPOs 

report the same hospital-specific data 

publicly that they report to the OPTN, 

the published data would provide an 

additional opportunity to verify the 

completeness and accuracy of the OPTN 

data. Furthermore, publication of 

hospital-specific organ donation data 

would be an effective way to promote 

the exchange of information among 

OPOs, hospitals, and the public. 

Therefore, we propose requiring OPOs 

to report hospital-specific organ 

donation data, including organ donor 

potential and the number of actual 

organ donors, at least annually to the 

public. We would suggest that OPOs 

include these data in their newsletters 

and their annual reports. 

We are interested in other avenues to 

hold hospitals more accountable for 

organ donation and for implementing 

6110 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

the CoP. In fact, the AOPO has 

requested that we ask for public 

comment regarding specific actions we 

might consider to address problems 

some OPOs have encountered in regard 

to their hospitals. For example, OPOs 

have complained to us that hospitals 

sometimes refer a brain dead patient 

only after the patient has been removed 

from the ventilator (rendering the 

patient medically unsuitable for organ 

donation) and that hospital staff 

physicians sometimes are reluctant to 

declare brain death, provide assistance 

in evaluating potential donors, or 

provide services for intraoperative 

donor management.

We believe it is important to point 

out, however, that in these specific 

situations (and many others), there is 

regulatory relief available to OPOs 

under the hospital and critical access 

hospital CoPs, which requires hospitals 

to refer patients whose death is 

imminent and to cooperate with their 

OPOs in maintaining potential donors 

while necessary testing and placement 

of organs takes place. This means that 

a hospital could be in violation of the 

CoP if it did not refer a brain dead 

patient before removing the patient from 

the ventilator or if the hospital did not 

provide the support services necessary 

to maintain a potential donor. 

We are aware that OPOs are reluctant 

to provide details about violations of the 

hospital CoP to us because they fear 

disturbing their relationships with 

hospitals. One OPO has stated, ‘‘it’s not 

our intention to find fault with anybody. 

This is a relationship business.’’

However, the CoP for organ, tissue, and 

eye procurement has been in effect since 

August 1998. We would suggest that if 

an OPO has not been able to urge a 

hospital into compliance with the CoP 

by now, it needs our assistance. We 

cannot aid hospitals and OPOs in 

improving their relationships and assure 

that all hospitals are complying with the 

CoP unless OPOs are willing to bring 

problems to our attention. Nevertheless, 

we are interested in receiving comments 

regarding other actions we might take to 

improve hospital compliance with the 

CoP and hold hospitals more 

accountable for organ donation.

[If you choose to comment on this issue, 

please include the caption ‘‘Hospital 

Accountability’’ at the beginning of your 

comments.] 

Condition: Information Management 

(Proposed § 486.330) 

[If you choose to comment on this 

section, please include the caption 

‘‘Information management’’ at the 

beginning of your comments.] 

This section incorporates the data 

maintenance and record keeping 

requirements now found at 

§ 486.304(c)(8). We believe these 

requirements should be retained to 

ensure that a smooth transition of 

records would occur if an OPO’s service 

area were taken over by another OPO 

and so that OPOs maintain adequate 

information about each donor. We 

propose that, as in current regulations, 

an OPO would be required to establish 

and use an information management 

system to maintain the required 

medical, social and identifying 

information for every donor and 

transplant recipient and develop and 

follow procedures to ensure the 

confidentiality and security of the 

information. 

OPOs have asked for guidance 

regarding how long records should be 

kept. We propose requiring OPOs to 

maintain donor and transplant recipient 

records for 7 years because the 

regulations that govern the OPTN at 

§ 121.11(a)(2)(i) require OPOs to retain 

records for 7 years. We also propose 

requiring certain additional data that 

OPOs would be required to keep in their 

donor records. 

Currently, OPOs are required to 

include the following in their donor 

records: information identifying the 

donor (for example, name, address, date 

of birth, social security number or other 

unique identifier, such as Medicare 

health insurance claim number), organs 

and (when applicable) tissues 

recovered, date of the organ recovery, 

and all test results. We propose 

requiring the following additional data 

elements: donor management data, 

current hospital history, past medical 

and social history, the pronouncement 

of death, and consent and next-of-kin 

information. We currently require OPOs 

to keep identifying information for each 

transplant recipient. We propose 

requiring OPOs to include a record of 

the disposition of organs recovered for 

transplantation.

In proposing these new data elements, 

we are expanding upon the data 

elements required for donor records 

under existing regulations at 

§ 486.304(c)(8). There are three reasons 

why we propose requiring these 

additional data elements. First, such 

data is critically necessary to the 

investigation of the transmission of 

infectious disease from organ donors. 

Recently, CMS and the Centers for 

Disease Control and Prevention (CDC) 

needed donor records (including donor 

management data, hospital history, past 

medical and social history, the 

pronouncement of death, and consent 

and next-of-kin information) to 

investigate two separate cases of 

Hepatitis C transmission from organ 

donors and to determine whether the 

donors had been tested, why they had 

not tested positive for Hepatitis C, and 

whether the donors had exhibited signs 

of Hepatitis C that should have been 

apparent before donation taking place. 

In addition, CMS and the CDC needed 

to quickly establish the disposition of 

all organs recovered from the infected 

donors to establish whether other organ 

recipients were infected. Although some 

of the data we propose requiring would 

be available from the hospital where a 

donor died, some would be available 

from the OPTN, and some would be 

available from the OPO, it is important 

for all data to be available in one 

location to provide speedy access in 

cases of disease transmission. 

In addition, CMS needs access to 

several of these additional data elements 

to determine whether an OPO has 

complied with the process performance 

measures. Donor management, hospital 

history, and past medical and social 

history would be used to assess 

compliance with § 486.344(a) and (b). 

Consent and next-of-kin information 

would be used to assess compliance 

with § 486.342. 

Finally, we believe the additional data 

elements we propose for donor records 

would provide an invaluable source of 

information for OPOs to use in their 

QAPI programs. For example, an OPO 

may want to review donors’ medical 

and social histories to assess and 

improve its protocol for obtaining 

medical and social histories from 

potential donor families. 

Condition: Requesting Consent 

(Proposed § 486.342) 

[If you choose to comment on this 

section, please include the caption 

‘‘Requesting consent’’ at the beginning 

of your comments.]

In addition to requesting consent for 

organ donation from families of 

potential donors, OPOs often request 

consent for tissue donation on behalf of 

their hospitals’ designated tissue banks. 

In April 2000, the ‘‘Orange County (CA) 

Register’’ (Register) published a five-part 

series of articles based on its 

investigation of the tissue banking 

industry. One of the allegations made by 

the Register was that tissue donor 

families were not being fully informed 

before making the decision to donate. 

The Register articles noted that families 

of potential donors often are not 

informed about how donated tissues 

may be used (for example, skin may be 

used for cosmetic surgery, as well as 

grafts for burn patients) or that some 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6111

tissue banks make profits from donated 

tissues. 

In January 2001, the OIG published a 

report entitled, ‘‘Informed Consent in 

Tissue Donation.’’ The OIG noted that in 

recent years, tissue banking and 

processing practices have gradually 

diverged from tissue donor families’

expectations. The expansion of the 

tissue banking industry, new 

technology, large profits, and tissue 

marketing practices have raised 

questions about the non-profit basis of 

tissue banking. Therefore, the OIG 

suggested that certain steps should be 

taken in regard to tissue donation to 

ensure that families and other decisionmakers are fully informed before making 

a decision. One of the OIG’s 

recommendations was that we add a 

provision to the OPO conditions for 

coverage to hold OPOs accountable for 

obtaining informed consent from tissue 

donor families when OPOs request 

consent on behalf of tissue banks. The 

OIG also recommended that we require 

OPOs to include tissue banks when 

developing and conducting training for 

hospital designated requestors for 

tissue. 

We agree with the OIG’s 

recommendations. Providing informed 

consent is an integral part of 

encouraging discretion and sensitivity 

with respect to the circumstances, 

views, and beliefs of potential donor 

families, which is required for hospitals 

and critical access hospitals under 

section 1138(a)(1)(A)(ii) of the Social 

Security Act, in hospital regulations at 

§ 482.45(a)(4), and in critical access 

hospital regulations at § 485.643, and 

which we propose as a requirement for 

OPOs in this proposed rule. Ensuring 

that all donor families and other 

individuals responsible for making 

donation decisions are fully informed 

before making a decision guards against 

negative publicity that may result if a 

donor family does not receive informed 

consent. As noted earlier in this 

preamble, negative perceptions of or 

publicity about tissue donation can 

affect the public’s attitude about organ 

donation and individuals’ willingness to 

donate. Therefore, we propose requiring 

that all requests made by OPOs for 

tissues, as well as organs, include a 

properly executed informed consent 

process. 

An OPO would be required to have a 

written protocol to ensure that, in the 

absence of a donor document, the 

individual or individuals with 

responsibility to make the donation 

decision are informed of their option to 

donate organs or tissues or to decline to 

donate. We note that with respect to 

informed consent, a potential donor 

may have executed a consent or 

indicated in an advance directive or 

power of attorney the individual who 

will make a decision about organ 

donation on his or her behalf. The OIG 

appended to its report a list of model 

elements of informed consent for organ 

and tissue donation developed by the 

American Association of Tissue Banks, 

AOPO, and the Eye Bank Association of 

America, as well as an informed consent 

policy for tissue donation developed by 

the National Donor Family Council. We 

have incorporated many of the 

recommendations made by these 

organizations into our proposal.

For example, the OIG noted that 

although tissue donor families assume 

the tissue they agree to donate will be 

used to meet important medical needs, 

tissue is sometimes processed into 

products used for elective cosmetic 

procedures. Tissues may also be used 

for research or education rather than 

transplantation. To address this issue, 

the National Donor Family Council 

recommends that tissue donor families 

be told they may restrict or limit use of 

the tissue they donate. We agree with 

this recommendation and propose 

requiring that individuals responsible 

for making the donation decision be 

informed that they may limit or restrict 

the use of donated organs or tissues. 

In addition, we propose requiring 

OPOs to provide to the individual(s) 

responsible for making the donation 

decision, at a minimum, a list of the 

organs or tissues that may be recovered; 

a description of all possible uses for the 

donated organs or tissues; information 

(such as non-profit or for-profit status) 

about organizations that will recover, 

process, and distribute the tissues; a 

description of the screening and 

recovery processes; information 

regarding access to and release of the 

donor’s medical records; an explanation 

of the impact the donation process may 

have on burial arrangements and the 

appearance of the donor’s body; 

information about the procedure for 

filing a complaint; contact information 

in case the individual(s) making the 

decision have questions; and a copy of 

the signed consent form. 

When developing protocols for 

informed consent for tissue donation, 

OPOs may wish to review the informed 

consent policies appended to the OIG 

report. The National Donor Family 

Council represents approximately 8,000 

donor families, and the American 

Association of Tissue Banks accredits 58 

tissue banks in the U.S. Their policies 

include specific descriptions of 

elements that address full disclosure for 

consent for tissue donation. 

We would note that a recent survey of 

tissue donor families conducted by the 

National Donor Family Council and 

Case Western Reserve University found 

that a large majority of families said 

they would have preferred receiving 

more, rather than less, information to 

aid them in their decision making. For 

example, 79 percent of families 

surveyed said they would have wanted 

to know that some tissue banks are forprofit entities. To guarantee that all 

donor families and other individuals 

responsible for making donation 

decisions have the information they 

need to make an informed decision, as 

well as to avoid a negative impact on 

organ and tissue donation, we believe 

information should be provided about 

all facets of the donation process before 

a donation decision is made. 

Finally, the family of the donor is 

likely to have many questions about the 

donation process, even if the OPO does 

not request consent. Thus, although we 

do not propose requiring an OPO to seek 

informed consent if the potential donor 

consented to donation before his or her 

death in a manner that satisfied the 

governing State law requirements, we 

propose requiring the OPO to provide 

information about the donation if it is 

requested by the donor’s family. 

Condition: Donor Evaluation and 

Management and Organ Placement and 

Recovery (Proposed § 486.344) 

[If you choose to comment on this 

section, please include the caption 

‘‘Donor evaluation and management, 

organ placement and recovery’’ at the 

beginning of your comments.] 

The current OPO regulations have 

minimal requirements for donor 

evaluation and management and organ 

placement and recovery. They require 

OPOs only to: (1) Have a system to 

allocate donated organs equitably 

among transplant patients consistent 

with specific CDC guidelines for 

preventing the transmission of HIV and 

with the rules of the OPTN; and (2) 

ensure that appropriate donor screening 

and infection tests consistent with CDC 

and OPTN guidelines are performed by 

a laboratory certified in the appropriate 

specialty or subspecialty in accordance 

with CLIA requirements. There are no 

provisions in our regulations addressing 

donor management or organ recovery.

We propose requiring every OPO to 

have written protocols for donor 

evaluation and management and organ 

placement and recovery. The OPO 

would be required to ensure that 

protocols meet current standards of 

practice and that established practices 

and criteria are designed to optimize the 

number of donors and the number of 

6112 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

organs recovered and transplanted per 

donor. 

As stated earlier, our OPO 

Coordinators have observed that the 

most successful OPOs have active, 

involved medical directors. Therefore, 

we are proposing requirements to 

ensure both that every OPO has a 

medical director and that medical 

directors are involved in the day-to-day 

oversight of clinical staff and the staff’s 

evaluation and management of potential 

donors. We propose that an OPO’s 

medical director would be responsible 

for ensuring that protocols for 

evaluation and management of donors 

are implemented correctly and 

appropriately to ensure every potential 

donor is thoroughly assessed for 

medical suitability for organ donation 

and clinically managed to optimize 

organ viability and function. 

Managing a brain dead potential 

donor so that organs remain 

transplantable is very difficult. In fact, 

experienced OPO procurement 

coordinators agree that it can be more 

difficult to manage a brain dead 

potential donor successfully than to 

manage a living, critically ill patient. 

Sometimes donors are lost at this point 

in the donation process because cardiac 

arrest occurs before organs can be 

recovered. Therefore, we propose that 

OPOs be required to implement a 

system that ensures the medical director 

or other qualified physician is available 

to assist in the medical management of 

a donor when the surgeon on call is 

unavailable. We believe these proposals 

would ensure that once consent is 

obtained, every medically suitable 

potential donor will go to surgery and 

every transplantable organ will be 

recovered. 

We believe detailed protocols whose 

implementation is well coordinated 

between the OPO medical director and 

procurement coordinators would work 

to safeguard against outcomes that 

hinder the goal of optimizing recovery 

of transplantable organs. The complex 

clinical interventions required for each 

stage of the donor evaluation and 

management and organ recovery 

processes contain numerous variables 

that would benefit from increased 

surveillance and accountability. 

An excellent example of the 

importance of following a protocol for 

donor management can be found in a 

recent OPTN/UNOS study of the UNOS 

‘‘Critical Pathway for the Organ Donor’’

protocol for donor management. The 

study found that when the critical 

pathway protocol was used, outcomes 

improved significantly. The number of 

organs recovered per donor increased by 

10.3 percent, and the number of organs 

transplanted per donor increased by 

11.3 percent. (Chabalewski, F., 

Rosendale, J., Edwards, C.: The Effect of 

a Critical Care Pathway on Donor 

Management Time and Cost—A Pilot 

Study. Presented at the American 

Association of Critical Care Nurses, May 

1, 2000.) The Secretary’s Advisory 

Committee on Transplantation (ACOT) 

recently recommended that OPOs be 

encouraged to develop, evaluate, and 

support the implementation of 

improved management protocols for 

potential donors. The ACOT noted that 

the UNOS ‘‘Critical Pathway’’ is a 

‘‘novel and improved’’ standard of care 

for heart and lung donors, and the 

Committee called for development of 

improved management standards for 

recovery of other types of organs.

Currently, the CDC’s ‘‘Guidelines for 

Preventing Transmission of Human 

Immunodeficiency Virus Through 

Transplantation of Human Tissue and 

Organs’’ are appended to our OPO 

regulations, but we are not proposing to 

include them in our new regulations. 

Once guidelines are appended to 

Federal regulations, agencies can 

incorporate new guidelines only 

through the rulemaking process. 

Therefore, we propose removing the 

CDC guidelines from the OPO 

regulations and requiring, instead, that 

OPOs arrange for donor screening and 

testing for infectious disease following 

current standards of practice. This 

requirement would give OPOs the 

flexibility to follow the most up-to-date 

guidelines for preventing transmission 

of infectious disease. We would expect 

OPOs to change their testing practices 

quickly if the organ donation and 

transplantation community agrees that a 

change is indicated. 

For example, in 2001 three transplant 

recipients were infected with the 

parasite that causes Chagas disease after 

receiving organs from a donor from 

Central America. One of the recipients 

later died from the disease. Chagas 

disease is endemic in Latin America but 

had not previously been reported in the 

United States. Although at present there 

is no test available in the United States 

to screen donors or organs for the 

presence of Chagas disease, if a test 

becomes available and the OPTN and 

CDC recommend that OPOs use the test 

to screen potential donors, we would 

regard that testing as being part of 

current standards of practice for donor 

testing. 

We propose requiring that all testing 

of potential donors (including point-ofcare testing and blood typing) be 

conducted by a laboratory that is 

certified in the appropriate specialty or 

subspecialty of service in accordance 

with part 493 (that is, the CLIA 

regulations). Thus, an OPO using its 

own mobile unit to perform point-ofcare testing for management of donors 

before organ recovery would be required 

to have the appropriate CLIA 

certification. The OPO would be 

required to ensure that the donor’s 

blood is typed using two separate blood 

samples. Furthermore, we would 

require OPOs to document donor 

records with all test results, including 

blood type, before organ recovery. 

To provide opportunity for 

improvements in partnerships between 

OPOs and the transplant hospitals in 

their service areas, we would require 

OPOs to establish protocols 

collaboratively with transplant hospitals 

that clearly define the roles and 

responsibilities of the OPO and the 

transplant hospital for all activities 

associated with donor evaluation, donor 

management, and organ recovery. 

In February 2003, a medical error 

occurred at a large university hospital 

that made headlines across the country. 

Surgeons at the hospital transplanted a 

heart and lungs from a type A donor 

into a type O recipient. The recipient 

immediately began to reject the 

mismatched organs, and a second 

transplant several days later from a 

donor of the correct blood type failed to 

save her life. Although a number of 

errors and mistaken assumptions on the 

part of the hospital and both OPOs 

involved in the procurement of the 

organs led to the mismatched 

transplant, it could have been prevented 

by better communication between the 

hospital and the OPOs involved in 

procuring and placing the organ. 

Therefore, we propose requiring OPOs 

to include in the protocol the 

procedures to be used to ensure that the 

blood type of the donor is compared 

with the blood type of the intended 

recipient by two OPO staff members 

before organ recovery takes place and 

that documentation of the donor’s blood 

type accompanies the organ to the 

transplant hospital. 

OPOs would be required to review the 

protocols periodically with their 

transplant hospitals to incorporate best 

practices and maximize placement of 

transplantable organs. We believe that 

implementation of current, 

comprehensive protocols would 

improve donor evaluation, management 

and organ recovery and contribute to the 

maximum number of organs per donor 

recovered and transplanted.

In our investigation of the 

mismatched transplant, we found that 

the OPOs involved did not obtain 

documentation of the recipient’s blood 

type or position on the waiting list from 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6113

the OPTN. Therefore, we propose 

requiring that before recovery of an 

organ for transplantation, an OPO must 

have written documentation from the 

OPTN showing, at a minimum, the 

intended recipient’s OPTN 

identification number and blood type, 

as well as the recipient’s position on the 

waiting list in relation to other suitable 

candidates. We have included 

additional safeguards in this proposed 

rule (see § 486.346) to prevent 

mismatched transplants. 

Section 371(b)(3)(E) of the PHS Act 

requires OPOs to ‘‘have a system to 

allocate donated organs among 

transplant patients according to 

established medical criteria.’’ The OPTN 

develops the medical criteria upon 

which allocation policies are based with 

the input of the organ donation and 

transplantation community. Therefore, 

we propose retaining the requirement in 

the current regulations that OPOs have 

a system to equitably allocate donated 

organs among transplant patients 

consistent with the rules of the OPTN. 

However, we propose adding language 

to clarify that the ‘‘rules’’ of the OPTN 

are those that have been approved as 

enforceable by the Secretary. 

We are proposing a requirement that 

OPOs develop and implement a 

protocol that maximizes placement of 

transplantable organs. This means that 

OPOs should be aware of organ 

acceptance criteria for centers outside 

their service areas and make every 

possible effort to place healthy organs. 

We would encourage OPOs to include 

organ placement in their QAPI programs 

and explore innovative ideas for 

maximizing both organ recovery and 

transplantation. 

According to the Collaborative’s 

report, LifeLink of Florida evaluates 

every brain death on-site at the hospital, 

regardless of the patient’s age, medical 

history, or social history, and makes 

every effort to find potential recipients 

for marginal or ‘‘extended criteria’’

organs. LifeGift’s philosophy includes 

‘‘turning potential donors previously 

considered unsuitable into actual 

donors.’’

Many OPOs have developed 

innovative methods for maximizing the 

number of organs they place and 

recover. For example, the Hawaii OPO 

has partnered with a California 

transplant hospital to arrange for hearts 

donated in Hawaii to be transplanted in 

California, even though the transport 

time to California is at the upper limits 

of the acceptable cold ischemic time for 

a heart. At the July 2002 meeting of the 

North American Transplant 

Coordinators Organization in 

Washington, DC, OPOs presented case 

studies and abstracts describing their 

successes in recovering organs from 

marginal donors. Gift of Life OPO in 

Philadelphia presented an abstract 

documenting its success in 

implementing a comprehensive 

initiative for recovering organs from 

pediatric donors after cardiac death 

(that is, non-heartbeating donors). From 

1995 through 2001, 55 organs recovered 

by the OPO from pediatric donors after 

cardiac death were successfully 

transplanted. Gift of Life also presented 

an abstract demonstrating the number of 

viable organs they recovered from 

donors over the age of 60 and a case 

study describing how optimal donor 

management, biopsy, and perfusion 

enabled them to recover viable kidneys 

from a donor with initially poor kidney 

function. 

Condition: Organ Preparation and 

Transport (Proposed § 486.346) 

[If you choose to comment on this 

section, please include the caption 

‘‘Organ preparation and transport’’ at 

the beginning of your comments.]

Our current regulations have minimal 

requirements for OPOs for organ 

preparation and transport. OPOs are 

required only to arrange for appropriate 

tissue typing of organs and to provide or 

arrange for transportation of organs to 

transplant hospitals. There are no 

requirements for organ packaging in the 

current regulations. 

We propose requiring OPOs to arrange 

for testing of organs for infectious 

disease and tissue typing of organs 

according to current standards of 

practice. The OPO would be required to 

ensure that testing and tissue typing of 

organs are conducted by a laboratory 

that is certified in the appropriate 

specialty or subspecialty of service in 

accordance with part 493 of this 

chapter. 

We propose requiring OPOs to 

develop and follow a protocol for 

packaging, labeling, handling and 

transporting organs in a manner that 

ensures their arrival without 

compromise to the quality of the organ 

or the health of the recipient. OPOs 

would be required to include 

procedures to check the accuracy and 

integrity of labels, packaging, and 

contents before transport, including two 

separate verifications of the data on the 

labels and in the documentation that 

accompanies an organ to a transplant 

center. 

The impetus for this proposal came 

from an incident that occurred in 

Illinois in 2000. In packaging organs for 

shipment, an OPO mixed up the label 

identifying a kidney intended for 

transplantation with the label for a heart 

intended for research. It was only after 

the intended kidney recipient had been 

anesthetized and surgery had begun that 

hospital staff discovered the OPO had 

sent a heart instead of a kidney. 

In investigating the incident, we 

discovered that while organ mix-ups are 

rare, they are not unheard of, and no 

one in the OPO community seemed 

surprised that it had happened. In fact, 

the OPTN/UNOS OPO Committee 

recently documented 15 instances of 

organ packaging errors that occurred 

over a period of only 6 months. These 

errors included three organs shipped 

without sufficient ice, a right kidney 

shipped instead of the left kidney 

expected by the transplant hospital, a 

vessel container leaking (thus 

compromising the sterile integrity of 

segments of the donor’s aorta and 

inferior vena cava intended for use in 

the transplant procedure), as well as 

other errors that may have resulted in 

organ wastage. Although the OPTN has 

packaging requirements for OPOs, 

clearly, the requirements have not been 

sufficient to prevent errors that waste 

organs and endanger recipients. In light 

of the critical nature of the organ 

shortage, such errors are unacceptable. 

Finally, an OPO would be required to 

mark all packaging in which organs are 

transported with the identification 

number, specific contents, and donor’s 

blood type. This requirement is one of 

our proposals to guard against 

transplantation of organs mismatched 

by blood type or delivery of the wrong 

organ to a transplant center. 

Condition: Quality Assessment and 

Performance Improvement (QAPI) 

§ 486.348 

[If you choose to comment on this 

section, please include the caption 

‘‘Quality Assessment and Performance 

Improvement’’ at the beginning of your 

comments.] 

There is no requirement in current 

regulations that OPOs have a QAPI 

program. Although our regulations for 

most Medicare providers and suppliers 

require, at the least, a quality assurance 

program (the ‘‘find a problem, fix it’’

approach), there is no corresponding 

requirement in the OPO regulations. 

QAPI is the process of using objective 

data to study and continually make 

improvements to all aspects of an 

organization’s operations and services. 

QAPI rests on the assumption that an 

organization’s own quality management 

system is the key to improved 

performance. It seeks to increase the 

amount and quality of information on 

which to base decisions and improve 

quality. QAPI programs allow health 

care entities to assess their functioning 

6114 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

continuously and make changes to 

improve their quality and efficiency.

QAPI is regarded by the health care 

community as the most efficient and 

effective method for improving the 

quality and performance of health care 

providers. QAPI has become so 

pervasive that in a recent publication of 

the Institute of Medicine (IOM) of the 

National Academy of Sciences, 

‘‘Crossing the Quality Chasm: A New 

Health System for the 21st Century,’’ the 

IOM recommended that the Department 

itself should monitor and track quality 

improvements in six key areas including 

safety, effectiveness, responsiveness to 

patients, timeliness, efficiency, and 

equity. 

However, as the focus on improving 

outcomes in health care shifted from 

quality assurance to QAPI, OPOs 

seemed to be left behind, perhaps 

because they do not provide hands-on 

health care to patients. Nevertheless, an 

OPO’s success in recovering healthy 

organs impacts patients who need 

transplants due to end-stage organ 

failure just as surely as if the OPO were 

providing direct care to those patients. 

Although some OPOs have strong 

QAPI programs and use them to effect 

change both within their own 

organizations and within their hospitals, 

some OPOs’ QAPI programs are 

inadequate to drive badly needed 

systemic changes. Some OPOs admit 

that, as a group, they tend to be reactive 

rather than proactive, fixing individual 

problems instead of systems. 

Nonetheless, it appears that OPOs are 

catching up with the rest of the health 

care community. We know that most 

OPOs have a quality improvement 

program. Some programs are 

comprehensive, highly structured, and 

completely integrated into the day-today operations of the OPO. OPOs with 

these programs utilize them for databased decision making and strategic 

planning. Other OPOs are still 

developing and formalizing their QAPI 

programs. 

In November 2001, AOPO conducted 

a survey to assess quality improvement 

programs among OPOs. Of the 35 OPOs 

that responded to the survey, 

approximately 40 percent had been 

developing a quality program for 2 years 

or less, and only 43 percent had 

designated an individual whose primary 

responsibility was coordinating and 

monitoring a quality improvement 

program. However, approximately 67 

percent had made quality improvement 

part of their strategic plans and had 

developed appropriate measures or 

indicators of work system effectiveness 

for most major activities. 

However, AOPO notes that due to 

several factors, there has been 

significant growth in quality 

improvement among OPOs since the 

November 2001 survey. These factors 

include: (1) The Department’s 

Breakthrough Collaborative, which 

utilizes QAPI-type strategies to improve 

donation rates; (2) the Department’s 

initiative to provide comparative data 

from the SRTR to all OPOs and the 

public; (3) new perspectives on quality 

improvement gleaned from individuals 

hired by OPOs from outside the OPO 

community; (4) sharing of quality 

improvement plans among OPOs; and 

(5) the growth and activism of AOPO’s 

Quality Council. These factors have 

provided all OPOs with opportunities to 

expand and improve their quality 

improvement programs. 

All six high-performing OPOs studied 

during the Organ Donation 

Breakthrough Collaborative have a 

process (such as death record reviews) 

for collecting hospital-specific data and 

using the data both in their hospital 

development programs and to effect 

change within their own organizations. 

New England Organ Bank collects and 

monitors hospital-specific data on 

requests, consents, organs recovered, 

and organs transplants and reviews the 

data with hospital leadership every 

month. Included in their QAPI program 

are ‘‘formalized feedback mechanisms,’’

such as weekly meetings with OPO staff, 

monthly meetings with hospital staff, 

post-donation briefings with all 

involved OPO and hospital staff, along 

with two data reporting mechanisms 

(quantitative and qualitative reports). 

We believe it is critical for every OPO 

to have such a comprehensive QAPI 

program (that is, a program that 

addresses all aspects of an OPO’s 

functioning and the functioning of its 

hospitals in the organ donation process). 

As a recent article describing 

characteristics of successful OPOs 

pointed out, ‘‘OPOs no longer have the 

luxury of using trial and error in 

determining which programs will 

increase organ donation, which factors 

are key for success.’’ (Shafer, T., Kappel, 

D., Heinrichs, D., Strategies for success 

among OPOs: a study of three organ 

procurement organizations. Journal of 

Transplant Coordination. V.7, No.1: 22–

31.) 

Therefore, we are proposing a 

requirement for every OPO to develop, 

implement, and maintain a 

comprehensive, data-driven QAPI 

program designed to monitor and 

evaluate all donation services, including 

services provided under contract or 

arrangement. The OPO’s QAPI program 

must include the use of objective 

measures to evaluate and demonstrate 

improved performance with regard to 

OPO activities.

These requirements are based on our 

commitment to encouraging continuous 

quality improvement for all Medicare 

providers and suppliers. As we develop 

new regulations, we are shifting our 

focus from targeting the substandard 

practices of a small number of poor 

performers to emphasizing the 

responsibility of all Medicare providers 

and suppliers for continuous quality 

improvement in their own 

organizations. QAPI is a regulatory 

requirement for hospitals, Medicare + 

Choice providers, and providers in the 

Program for All-Inclusive Care for the 

Elderly (PACE). QAPI has been 

proposed as a requirement for home 

health agencies and rural health clinics. 

We believe a requirement for OPOs to 

have a QAPI program will encourage 

continuous quality improvement, as 

well as the use of best practices, as 

determined by the individual OPO and 

the OPO community. 

We do not intend to stipulate specific 

activities an OPO must include in its 

QAPI program. However, we suggest 

that all OPOs track and take actions to 

improve their consent rates. Although 

knowledge is the foundation for 

performance improvement, some OPOs 

do not know their consent rates, either 

for their service area as a whole or for 

individual hospitals. Nationwide, the 

consent rate to organ donation hovers 

around 50 percent, and it is generally 

agreed that families’ failure to consent 

to donation is the single most important 

roadblock to increasing donation. 

Although there is some evidence that 

public education efforts targeted toward 

increasing the public’s awareness of and 

support for organ donation may result in 

an increase in consent rates, the single 

greatest opportunity for increasing 

consent rates lies within the interaction 

among OPO staffs, hospital staffs, and 

potential donor families. 

We propose requiring an OPO’s QAPI 

program to include objective measures 

to evaluate and demonstrate improved 

performance with regard to OPO 

activities, such as hospital development, 

designated requestor training, donor 

management, timeliness of response to 

hospital referrals, consent practices, 

organ recovery, and organ packaging 

and transport. The OPO would be 

required to take actions that result in 

performance improvements and track 

performance to ensure that 

improvements are sustained. 

There are many resources available to 

OPOs to develop and improve QAPI 

within their organizations. The AOPO 

Quality Council is available to assist all 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6115

AOPO members interested in QAPI. The 

Council has a quality improvement list 

serve and a chat room used for 

mentoring and for scheduled 

discussions of quality improvement 

topics. The Council holds meetings for 

all interested OPOs three times per year, 

with training in basic and intermediate 

level QAPI, basic quality assurance 

statistics and data analysis, 

implementation of quality plans, flow 

charting, root cause analysis, and 

preparation for audits and surveys. 

In addition, the resources of both 

CMS (through the OPO Coordinators) 

and HRSA’s Division of Transplantation 

(DOT) are available to OPOs to assist 

them in implementing QAPI. CMS OPO 

Coordinators are always available to 

assist OPOs with their QAPI programs. 

Once a final rule is published, the CMS 

OPO Coordinators will provide 

guidance to OPOs so that they 

thoroughly understand how to 

implement the QAPI requirements in 

the regulation. 

When OPOs are surveyed to see if 

they meet the requirements for QAPI, 

surveyors initially would focus on 

whether an OPO has or is developing a 

QAPI program. If a QAPI program were 

still in the development phase, 

surveyors would determine what 

remains to be accomplished, what steps 

the OPO needed to take to have a 

comprehensive, fully integrated 

program, and what resources it would 

need to reach that goal. When an OPO 

is surveyed for the QAPI requirement 

for the first time under the final OPO 

rule, the OPO would not be cited for 

being out of compliance, as long as it 

had a QAPI program in some stage of 

development and was working to 

expand and improve the program with 

the goal being a comprehensive, datadriven program to monitor and evaluate 

all donation services.

The hospital CoP at § 482.45(a)(5) and 

critical access hospital CoP at § 485.643 

require hospitals to cooperate with 

OPOs in reviewing death records to 

improve identification of potential 

donors. We included this requirement 

in the hospital and critical access 

hospital CoPs because missed 

opportunities for donation are not 

uncommon, and review of hospitals’

death records is essential for both OPOs 

and the hospitals they serve to 

determine where and how systems need 

to be changed to ensure future potential 

donors are identified. 

We propose requiring hospital death 

record reviews as a component of every 

OPO’s QAPI program. OPOs would be 

expected to use data from their death 

record reviews as the basis for their 

quality improvement efforts. We believe 

that to have sufficient data on which to 

base changes in their organizations, 

OPOs must perform death record 

reviews on an ongoing basis. Death 

record reviews provide information 

about nearly the entire range of an 

OPO’s critical operations, as well as the 

performance of the OPO’s hospitals in 

the donation process. Death record 

reviews provide information about the 

timeliness of hospital referrals of 

potential donors, the timeliness of the 

OPO’s response, OPO or hospital staffs’

interactions with family members, 

management of potential donors, and 

other matters that affect quality. The 

information OPOs gain from periodic 

death record reviews can be used to 

identify and correct systemic problems 

that interfere with organ donation. 

In a 1997 article, ‘‘Medical Record 

Review as a Measure of the 

Effectiveness of Organ Procurement 

Practices in the Hospital,’’ [The Joint 

Commission Journal on Quality 

Improvement, Vol. 23, No. 6, June 1997] 

The Partnership for Organ Donation 

concluded that death record reviews 

provide a solid foundation for 

identifying gaps in organ procurement 

performance, implementing and 

tracking the success of [quality 

improvement] initiatives, and 

monitoring ongoing performance The 

researchers recommended that OPOs 

conduct death record reviews annually 

at large hospitals where medically 

suitable donor candidates are 

concentrated and provide feedback from 

the death record reviews to key hospital 

staff concerning practice improvements 

that could be adopted. The researchers 

suggested annual death record reviews 

at hospitals with 150 or more beds or 

with trauma centers. 

As stated earlier, the organ donation 

community recognizes that death record 

reviews are the ‘‘gold standard’’ for 

assessing donor potential and improving 

organ donation rates. In fact, in 

discussions with directors of OPOs that 

perform death record reviews, we were 

told that OPOs that do not perform them 

are ‘‘missing the boat’’ because they 

have no way of knowing their true 

donor potential and no way of 

identifying and addressing problems. 

Although death record reviews are labor 

intensive, they are well worth the effort 

expended. 

The Michigan OPO, Gift of Life, 

recently demonstrated what can be 

accomplished by using death record 

reviews as the basis for improving organ 

donation rates. The OPO used data from 

death record reviews performed 

monthly in Michigan’s leading organ 

donation hospital to determine that 

organ donors could be increased in key 

critical care units in the hospital. The 

OPO partnered with the hospital to 

increase organ donation rates. The OPO 

made a commitment to (1) Respond on 

site to every referral; (2) provide 

monthly in-service education to resident 

physicians in the key units; and (3) 

follow up on all cases within 96 hours 

of every referral to obtain information 

for improving systems for donation. The 

result—from 2000 to 2001, the hospital’s 

organ donation rate increased by 48 

percent to 40 donors and the rate of 

organs recovered increased by 43 

percent to 143 organs. 

At the Joint American Transplant 

Meeting, ‘‘Transplantation 2001’’

conference held from May 11–16 2001 

in Chicago, a group of researchers, 

including the researchers from the 

AOPO death record review study, 

presented results from a study that used 

death record reviews to understand 

opportunities for increasing organ 

donation within an OPO service area. 

The researchers concluded that: (1) 

Increasing organ donation can be 

achieved by focusing on hospitals with 

150 or more beds known to have organ 

donor potential by death record review; 

(2) death record reviews offer an 

objective way to prioritize hospitals by 

potential and to tailor interventions 

within each hospital to address specific 

obstacles to donation; and (3) by 

focusing on hospitals with 150 or more 

beds, OPOs can reach more than 90 

percent of their target market.

Therefore, we propose that an OPO be 

required to conduct death record 

reviews in every Medicare or Medicaid 

participating hospital with which it has 

an agreement if the hospital has 150 or 

more beds or if it has a level I or level 

II trauma center, with the exception of 

psychiatric or rehabilitation hospitals. 

(We propose excluding psychiatric and 

rehabilitation hospitals because of their 

limited organ donation potential.) When 

missed opportunities for donation are 

identified, the OPO would be required 

to implement actions to improve 

performance. 

As part of the QAPI process, an OPO 

would be required to investigate adverse 

events and complete a thorough 

analysis. An adverse event for an OPO 

could be caused by mismanagement of 

a donor, failure to test organs for 

infectious disease, failure to compare 

the blood type of the donor with the 

blood type of the intended recipient, or 

mixing up the labels on packaged 

organs. Examples of situations involving 

direct patient outcomes that might 

qualify as adverse events include but are 

not limited to: (1) Avoidable loss of a 

medically suitable potential donor for 

whom consent for donation has been 

6116 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

obtained; (2) avoidable loss of a viable 

organ; (3) transmission of infectious 

disease to a recipient, and delivery to a 

transplant center of the wrong organ (for 

example, a left kidney instead of a right 

kidney or a kidney instead of pancreas) 

or an organ whose blood type does not 

match the blood type of the intended 

recipient. 

In addition, we are proposing that an 

OPO be required to report an adverse 

event to us within 10 business days of 

becoming aware of the event and 

provide written documentation of the 

investigation and analysis of the adverse 

event to us within 15 days of becoming 

aware of the event. The OPO would be 

required to implement changes and 

safeguards to decrease the probability of 

the adverse event recurring. We believe 

that this formal analysis is essential to 

examining an OPO’s existing policies 

and practices, improving the organ 

donation process, and improving 

outcomes. We believe the proposed time 

frames for reporting and providing 

written documentation would be 

sufficient and would ensure prompt 

attention by the OPO to adverse events. 

We believe the requirements we 

propose for OPOs to develop and 

implement QAPI programs, perform 

death record reviews, report and 

analyze adverse events, and operate 

under a CAP, as needed, would provide 

concrete steps OPOs can use to improve 

their operations and increase organ 

donation. We also believe these 

proposed requirements are the single 

most important provision in this 

proposed rule to fulfill the 

congressional mandate for process 

performance measures based on 

empirical evidence of organ donor 

potential and other related factors in 

OPO service areas. 

Additional Conforming Changes 

(§ 413.200, (§ 413.202, § 441.13, and 

§ 498.2) 

In addition to the changes discussed 

above, we are also proposing a number 

of conforming and correcting 

amendments. 

As discussed previously, we propose 

making changes to § 498.1 to remove 

OPOs from the definition of ‘‘supplier’’

under part 498. Since we propose a 

process for OPOs to appeal a decertification on substantive and 

procedural grounds, OPOs would not 

need the part 498 appeals process. 

We also propose to correct a number 

of cross-references related to the 

certification of OPOs. In § 441.13(c), and 

in § 498.2, we propose to change 

references to ‘‘part 485, subpart D’’ to 

read, ‘‘part 486, subpart G’’. On 

September 29, 1995 (60 FR 50447), the 

conditions for coverage for OPOs was 

re-designated from part 485, subpart D 

to part 486, subpart G. When this redesignation occurred, these two 

references were not amended to reflect 

the change.

In addition, § 413.202 refers to OPOs 

‘‘as defined in § 435.302 or this 

chapter’’. This is an error. We propose 

correcting this reference to read ‘‘as 

defined in § 486.302 of this chapter’’. 

Request for Comments on Related Issues 

Living Donation 

[If you choose to comment on this 

section, please include the caption 

‘‘OPO role in living donation’’ at the 

beginning of your comments.] 

In 2001, living donors outnumbered 

deceased donors for the first time, with 

6,445 living donors and only 6,077 

deceased donors. However, with the 

exception of two pilot programs in 

which OPOs assist transplant hospitals 

by arranging for medical and 

psychological evaluations of voluntary 

living kidney donors, the 59 OPOs do 

not play a role in living donation; their 

mission is to increase the number of 

deceased donors. Given the 

demonstrated risks to donors (primarily 

living liver donors), we believe that 

living donation should remain a 

medical decision between individuals 

interested in donating and their 

physicians. However, in view of the 

increasing importance of living 

donation, we are specifically requesting 

public comments on what role, if any, 

OPOs should play in living donation. 

Public Education 

[If you choose to comment on this 

section, please include the caption 

‘‘Public Education’’ at the beginning of 

your comments.] 

The current regulations at 

§ 486.306(p) require that OPOs conduct 

and participate in professional 

education concerning organ 

procurement, but they do not contain a 

requirement for public education. 

However, most OPOs are aware of the 

importance of the role public education 

plays in reaching ethnic populations, 

dispelling myths about organ donation, 

and addressing other issues that create 

barriers for consent to donation. Many 

in the OPO community believe that 

targeted public education about organ 

donation plays a key role in overcoming 

these barriers. Some researchers 

however, believe that available funding 

should go to basic research, professional 

education, and hospital development 

rather than public education. 

While we believe that systematic 

efforts by OPOs to identify specific 

barriers to donation, along with public 

education programs designed to address 

those barriers, may result in increased 

rates of consent to donation among 

targeted populations, the OPO 

community appears to lack consensus 

about this issue. Therefore, we have not 

included requirements for public 

education in this proposed rule. 

However, we are specifically requesting 

comments on the advisability of 

requiring OPOs to conduct public 

education based on systematic 

evaluation of specific barriers to 

donation within their individual service 

areas. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we 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 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires that we 

solicit comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected.

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements 

(ICRs): 

General Requirements (§ 486.304) 

For designation purposes, an 

organization would have to meet 

specified requirements, including: 

It would have to have accounting and 

other fiscal procedures necessary to 

assure the fiscal stability of the 

organization, including procedures to 

obtain payment for organs provided to 

transplant centers. 

It would have to submit to CMS a 

written application for designation, 

using the application form prescribed by 

CMS. 

It would have to document that it has 

a defined service area that meets the 

requirements of § 486.306. 

An OPO would have to enter into an 

agreement with CMS. In the agreement, 

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the OPO would have to agree to do 

comply with the following ICRs: 

(1) Maintain compliance with cited 

laws, regulations and rules of the OPTN, 

as defined by § 486.20, and to report 

promptly to the Secretary any failure to 

do so. 

(2) File a cost report in accordance 

with § 413.24(f) of this chapter within 5 

months after the end of each fiscal year. 

(3) Provide budget or cost projection 

information as may be required to 

establish an initial interim payment 

rate. 

The ICRs in this section are those that 

would require an OPO to have 

accounting and other fiscal procedures; 

to submit a written application for 

designation, using a form prescribed by 

CMS; to enter into an agreement with 

CMS; and to document that it has a 

defined service area that meets specified 

requirements. 

These ICRs are currently approved 

under OMB approval #0938–0512. 

OPO Service Area Size Designation and 

Documentation Requirements 

(§ 486.306) 

Under this section, an OPO would 

have to make available to CMS 

documentation verifying that the OPO 

meets the requirements of paragraph (b) 

and (c) of this section at the time of 

application and throughout the period 

of its designation.

Under paragraph (c), Service area 

location and characteristics, an OPO 

would have to precisely define and 

document a proposed service area’s 

location through the following 

information: 

(1) The names of counties (or parishes 

in Louisiana) served or, if the service 

area includes an entire State, the name 

of the State. 

(2) Geographic boundaries of the 

service area for which U.S. population 

statistics are available. 

(3) Total population in service area. 

(4) The number of and the names of 

hospitals in the service area with an 

operating room and the equipment and 

personnel to retrieve organs. 

The ICR in this section would be that 

requiring making documentation 

available. We believe that it would take 

a typical OPO an average of 1 hour to 

make the information available. There 

are 59 OPOs that would have to comply 

with this requirement; therefore, there 

would be a total of 59 hours needed to 

comply annually. 

Designation of One OPO for Each 

Service Area (§ 486.308) 

If CMS changes the OPO designated 

for an area, hospitals located in that area 

would have to enter into agreements 

with the newly designated OPO or 

submit a request for a waiver in 

accordance with paragraph (e) of this 

section within 30 days of notice of the 

change in designation. 

A hospital would be able to request 

and CMS might grant a waiver 

permitting the hospital to have an 

agreement with a designated OPO other 

than the OPO designated for the service 

area in which the hospital is located. To 

qualify for a waiver, the hospital would 

have to submit data to CMS establishing 

that—

(1) The waiver is expected to increase 

organ donations; and 

(2) The waiver 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. 

The burden associated with this 

section is the time it would take a 

hospital to request a waiver and to 

create an agreement with an OPO. We 

estimate that there will be 6 hospitals 

that would request a waiver and that all 

of these would need to enter into an 

agreement with the designated OPO. 

Under 5 CFR 1320.3(c), a ‘‘collection 

of information’’ does not include 

requirements imposed on fewer than ten 

entities. Therefore, the ICRs of this 

section are not subject to the PRA. 

Changes in Ownership or Service Area 

(§ 486.310) 

Under this section, a designated OPO 

considering a change in ownership or in 

its service area would have to notify 

CMS before putting it into effect and 

would have to obtain prior CMS 

approval. In the case of a service area 

change that results from a change of 

ownership due to merger or 

consolidation, the entities would have 

to submit anew the information required 

in an application for designation. The 

OPO would have to provide information 

specific to the board structure of the 

new organization, as well as operating 

budgets, financial information, or other 

written documentation CMS determines 

to be necessary for designation. 

The burden associated with this 

section is the time it takes to gather and 

submit the information CMS needs. We 

estimate that two OPOs would be 

affected annually and that it will be the 

same amount of time it would take a 

potential OPO requesting designation 

and is covered under OMB approval 

#0938–0512. 

De-Certification (§ 486.312)

Under this section, if an OPO wishes 

to terminate its agreement, it would 

have to send written notice of its 

intention with the proposed effective 

date to CMS. In the case of voluntary 

termination, the OPO would have to 

give prompt public notice of the date of 

termination, and such information 

regarding the effect of that termination 

as CMS may require, through 

publication in local newspapers in the 

service area. In the case of involuntary 

termination, CMS gives notice of the 

date of termination. 

The burden associated with these 

requirements is the time it would take 

to send written notice to CMS and to 

publish pertinent information in the 

local newspapers. We estimate that one 

OPO would be affected by these 

requirements per year. 

Under 5 CFR 1320.3(c), a ‘‘collection 

of information’’ does not include 

requirements imposed on fewer than ten 

entities. Therefore, the ICRs of this 

section are not subject to the PRA. 

Appeals (§ 486.314) 

Under this section, if an OPO’s decertification is due to involuntary 

termination or non-renewal of its 

agreement with CMS, the OPO may 

appeal the de-certification on 

substantive or procedural grounds. The 

OPO must file its appeal within 30 

calendar days of the date of the notice 

of de-certification. In its appeal, the 

OPO may submit evidence to 

demonstrate why it should not be decertified. 

The burden associated with this 

provision is the time it will take an OPO 

to file an appeal. We do not expect to 

decertify more than three OPOs in a 

given year. 

Under 5 CFR 1320.3(c), a ‘‘collection 

of information’’ does not include 

requirements imposed on fewer than ten 

entities. Therefore, the ICRs of this 

section are not subject to the PRA. 

Re-Certification and Competition 

Processes (§ 486.316) 

Under this section, OPOs competing 

for the open service area must submit an 

acceptable plan to increase organ 

donation in the open service area. An 

acceptable plan to increase organ 

donation would, at a minimum: 

(1) Be based on the competing OPO’s 

experience and success in its own 

service area; 

(2) Include an analysis of existing 

barriers, both internal and external, to 

increasing organ donation in the open 

area; and 

(3) Provide a detailed description of 

specific activities and interventions for 

increasing organ donation in the open 

area.

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The burden associated with this 

requirement is the time it would take to 

create the plan and to submit it. We 

expect that it would take approximately 

16 hours to develop an acceptable plan 

to increase organ donation. In each of 

the 1996, 1998, and 2000 re-certification 

cycles, approximately two to three 

OPOs failed the performance standards. 

Therefore, we do not anticipate 

terminating more than three OPOs in 

any four-year period. In previous recertification cycles no more than two 

OPOs have competed for an open 

service area. Therefore, we do not 

believe that more than two OPOs would 

compete for an open area. Therefore, we 

expect that no more than 6 OPOs would 

compete for service areas of OPOs being 

de-certified by CMS. 

We propose limiting competition for 

the service areas of OPOs that have met 

the conditions of coverage to OPOs that 

have met 4 out of 5 outcome measures 

at 100 percent of the mean and whose 

conversion rate of potential donors to 

actual donors is at least 15 percentage 

points higher than the incumbent’s 

conversion rate. It is likely that no more 

than 15 OPOs (those in the upper 

quartile) would fall into this category. 

Therefore, we expect that no more 

than 21 OPOs would want to develop an 

acceptable plan to increase organ 

donation as part of a bid to expand into 

a new service area. Assuming that it 

would take 16 hours to develop such a 

plan, the burden would be 336 hours. 

Condition: Relationships With 

Hospitals, Tissue Banks, and Eye Banks 

(§ 486.322) 

Under this section, an OPO would 

have to have a written agreement with 

95% of the Medicare and Medicaid 

hospitals in its service area that have 

both a ventilator and an operating room, 

that describes the responsibilities of 

both the OPO and hospital in regard to 

the requirements for hospitals in 

§ 482.45. The agreement would have to 

address the requirement in § 486.326 

that the OPO would have to maintain 

credentialing records for physicians 

who routinely recover organs in 

hospitals under contract or arrangement 

with the OPO and would have to assure 

that physicians and other practitioners 

who recover organs in hospitals are 

qualified and trained. 

The burden associated with these 

ICRs would be the time it will take an 

OPO to enter into an agreement with a 

hospital. Currently, OPOs are likely to 

have agreements with all hospitals in 

their service areas because the hospital 

CoP for organ, tissue, and eye 

procurement, which was effective 

August 21, 1998 (see section 482.45) 

requires all hospitals to have agreements 

with their OPO. We believe that it 

would take an average of two hours to 

draft an agreement with a hospital. 

Condition: Administration and 

Governing Body (§ 486.324) 

Under this section, the OPO would 

have to have bylaws for its board(s) that 

address conflicts of interest, length of 

terms, and criteria for selecting and 

removing members. 

A governing body or individual 

would have to have full legal authority 

and responsibility for the management 

and provision of all OPO services and 

would have to develop and implement 

policies and procedures necessary for 

the effective administration of the OPO, 

including services furnished under 

contract or arrangement, fiscal 

operations, and continuous quality 

assessment and performance 

improvement. 

The OPO would have to have a 

procedure to address conflicts of 

interest for the governing body or 

individual described above. 

The burden associated with the above 

requirements is the time it would take 

an OPO to create bylaws and to develop 

policies and procedures necessary for 

the effective administration of the OPO. 

It is usual and customary business 

practice to have such bylaws, policies, 

and procedures; therefore, there would 

be no additional burden.

Condition: Human Resources 

(§ 486.326) 

The first ICR in this section is that we 

would require the OPO to have a written 

policy that addresses conflicts of 

interest for the OPO’s director, medical 

director, and senior management, and 

procurement coordinators. 

Another ICR would be that the OPO 

must maintain credentialing records for 

physicians who routinely recover organs 

in hospitals with which the OPO has an 

agreement. 

The third ICR is that the OPO would 

have to reevaluate staff competency at 

least yearly and provide individual job 

descriptions and performance 

expectations to staff. 

The burden associated with this 

section is the time it would take an OPO 

to document policy, maintain records 

and to provide job descriptions and 

expectations. These requirements reflect 

usual and customary business practices 

and thus do not create any additional 

burden. 

Condition: Reporting of Data (§ 486.328) 

Under this section, the OPO would 

have to provide individually 

identifiable, hospital-specific organ 

donation and transplantation data to the 

OPTN and the SRTR, as directed by the 

Secretary. The OPO would have to 

provide hospital-specific data directly to 

transplant hospitals, annually. In 

addition, the OPO would be required to 

provide individually identifiable, 

hospital-specific organ donation and 

transplantation and other information to 

the Secretary, as requested. Such data 

may include, but are not limited to—

(1) Number of hospital deaths; 

(2) Results of death record reviews; 

(3) Number and timeliness of referral 

calls from hospitals; 

(4) Potential donor denominator (as 

defined in 486.302); 

(5) Data related to non-recovery of 

organs, 

(6) Data about consents for donation; 

(7) Number of donors; 

(8) Number of organs recovered (by 

type of organ); and 

(9) Number of organs transplanted (by 

type of organ). 

This section would also require that 

potential donor data reported to the 

OPTN to be used for OPO recertification would have to include data 

for all deaths that occurred in hospitals 

in the OPO’s service area, unless a 

hospital has a waiver to work with a 

different OPO. If an OPO determines 

through death record review or other 

means that the potential donor 

denominator data it reported to the 

OPTN was incorrect, it must report the 

corrected data to the OPTN.

The OPO would have to report 

hospital-specific organ donation data to 

the public at least annually. 

The burden associated with these 

requirements is the time it would take 

the OPOs to report certain information. 

We believe that this would take no more 

than 4 hours per OPO per year, or a 

national total of 236 hours. In addition, 

although it appears this requirement has 

the potential to add a significant new 

reporting burden, OPOs are required as 

a condition of their membership in the 

OPTN to report a large amount of data 

to the OPTN (which, in turn, provides 

the data to the SRTR for analysis). For 

example, the cadaver donor registration 

form (OMB approval #0915–0157) OPOs 

are required to complete for each donor 

contains more than 300 data elements. 

In addition, 42 CFR 121.11(b)(2) 

requires OPOs and transplant hospitals 

to submit information about transplant 

candidates, transplant recipients, organ 

donors, transplant program costs and 

performance, and ‘‘other information 

that the Secretary deems appropriate.’’

Thus, most information needed by the 

OPTN, the SRTR or the Department is 

already being reported by OPOs. 

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We cannot quantify the number of 

hours it would take to comply with the 

data reporting requirement, as data 

would be requested on an as-needed 

basis. We believe that almost any OPO 

data needed by CMS or other agencies 

within the Department could be 

obtained from the OPTN or the SRTR. 

We are including this provision only to 

give CMS and other agencies the 

flexibility to request data from OPOs in 

the event that needed data cannot be 

obtained expeditiously from the OPTN 

or the SRTR. We would not request data 

from OPOs if the data were readily 

available from other sources. 

Concerning the requirement that 

OPOs give data to the public, almost all 

OPOs publish newsletters to inform the 

public of their activities, and, most 

likely, OPOs would report the hospital 

data in their newsletters at very little 

additional cost. For those OPOs that do 

not publish newsletters, we estimate 

that it would take 4 hours to create a 

document suitable for publication 

yearly. We estimate that three OPOs do 

not have newsletters, for an annual 

burden of 12 hours. 

Condition: Information Management 

(§ 486.330) 

The ICRs under this section would 

require the OPO to maintain a record for 

every donor. The record would have to 

include, at a minimum, information 

identifying the donor (for example, 

name, address, date of birth, social 

security number), organs and (when 

applicable) tissues and eyes recovered, 

date of the organ recovery, donor 

management data, all test results, 

current hospital history, past medical 

and social history, pronouncement of 

depth, consent and next-of-kin 

information. Donor records would have 

to be maintained in a human readable 

and reproducible format for 5 years. 

The OPO would have to maintain data 

in a format that can readily be 

continued by a successor OPO and 

would have to provide to CMS copies of 

all records, data, and software necessary 

to ensure uninterrupted service by a 

successor OPO. Records and data 

subject to this requirement would 

include records of individual donors, 

records on transplant candidates 

(including identifying data and data on 

immune system and other medical 

indications) and procedural manuals 

and other materials used in conducting 

OPO operations. 

Although these ICRs would be subject 

to the PRA, we believe that all of them 

reflect usual and customary business 

practice and therefore have no added 

burden. 

Condition: Informed Consent (§ 486.342) 

The ICRs of this section would require 

that an OPO have a written protocol to 

ensure that the individual(s) making the 

donation decision for each potential 

organ donor is informed of their options 

to donate organs and tissues or eyes 

(when the OPO is making a request for 

tissues or eyes) or to decline to donate 

and are given sufficient time to consider 

their decisions and sufficient 

information on which to base fully 

informed decisions. The OPO would 

have to provide to the individual(s) 

making the donation decision, at a 

minimum, the following: 

(1) A list of the organs, tissues, or eyes 

to be recovered, 

(2) All possible uses for the donated 

organs and/or tissues, 

(3) The information that the 

individual(s) have the right to limit or 

restrict use of the organs or tissues, 

(4) A description of the screening and 

recovery processes, 

(5) Information (such as profit or nonprofit status) about organizations that 

will recover, process, and distribute 

tissue, 

(6) Information regarding access to 

and release of the donor’s medical 

records, 

(7) An explanation of the impact the 

donation process will have on burial 

arrangements and the appearance of the 

donor’s body, 

(8) Information about the procedure 

for filing a complaint,

(9) Contact information in case the 

individual(s) have questions, and 

(10) A copy of the signed consent 

form. 

If an OPO does not request consent to 

donation because a potential donor 

consented to donation prior to his or her 

death in a manner that satisfied 

applicable State law requirements, the 

OPO must provide information about 

the donation to the family of the 

potential donor, as requested. 

We believe that all OPOs currently 

have policies regarding informed 

consent, so there would basically be no 

additional burden to them as the 

policies are usual and customary 

business practice. (Some OPOs might 

have to add some information, which 

could minimally increase the time it 

takes to inform the individual(s) making 

the donation decision.) 

Condition: Donor Evaluation and 

Maintenance and Organ Placement and 

Recovery (§ 486.344) 

Under this section, the OPO must 

have an effective written protocol for 

donor evaluation and management and 

organ placement and recovery. 

The OPO must document the donor’s 

record with all test results, including 

blood type, prior to organ recovery. 

Prior to recovery of an organ for 

transplantation, the OPO must have 

written documentation from the OPTN 

showing, at a minimum, the intended 

recipient’s position on the waiting list 

in relation to other suitable candidates 

and the recipient’s OPTN identification 

number and blood type. 

The burden associated with this 

requirement is the time it would take to 

create the protocols. We believe that 

good business practices would dictate 

that an OPO have written protocols that 

meet the requirements of this section. 

Therefore, there would be no additional 

burden. 

Condition: Organ Preparation and 

Transport (§ 486.346) 

The ICR in this section requires that 

the OPO develop and follow a written 

protocol for packaging, labeling, 

handling and shipping of organs in a 

manner that ensures their arrival 

without compromise to the quality of 

the organ or health of the recipient. The 

protocol would have to include 

procedures to check the accuracy and 

integrity of labels prior to transport. 

The burden associated with this 

requirement is the time it would take to 

create the protocols. We believe that 

good business practices would dictate 

that an OPO have written protocols that 

meet the requirements of this section. 

Therefore, there would be no additional 

burden.

Section 486.348 Condition: Quality 

Assessment and Performance 

Improvement (QAPI) 

The ICRs under this section would 

require the OPO to develop, implement, 

and maintain a comprehensive, datadriven quality assessment and 

performance improvement (QAPI) 

program designed to monitor and 

evaluate ongoing and overall 

performance of all donation services, 

including services provided under 

contract or arrangement 

An OPO would have to establish in 

writing a policy to address adverse 

events that occur during any phase of an 

organ donation case. The policy would 

have to address, at a minimum, the 

process for identification, reporting, 

analysis, and prevention of adverse 

events. 

The OPO would have to report an 

adverse event to CMS and would have 

to provide to CMS written 

documentation of the investigation and 

analysis of the adverse event within 15 

days of reporting the adverse event. 

6120 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

The burden associated with these 

requirements would be the time 

required to develop a QAPI and policy 

regarding adverse events. It is also the 

time it would take to report the adverse 

events to CMS. 

We believe that, as part of its usual 

and customary business, a typical OPO 

would already have a QAPI and a policy 

regarding reviewing adverse events. 

While we believe that each of the 58 

OPOs already has a QAPI program in 

place, the burden of reporting adverse 

events is subject to the PRA. We 

estimate that on average, CMS would 

receive 30 adverse event reports 

annually. We have assumed that each 

report would require 30 minutes to 

prepare, yielding a total annual burden 

of 15 hours. 

If you comment on these information 

collection and record keeping 

requirements, please mail copies 

directly to the following:

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attn.: Dawn Willinghan, CMS–3064–

P, Room C5–14–03, 7500 Security 

Boulevard, Baltimore, MD 21244–

1850. 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, Attn: Christopher Martin, CMS 

Desk Officer. 

Comments submitted to OMB may 

also be e-mailed to the following 

address: e-mail: CMartin@omb.eop.gov; 

or faxed to OMB at (202) 395–6974. 

IV. Response to Comments 

Because of the large number of items 

of correspondence we normally receive 

on Federal Register documents 

published for comment, we are not able 

to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, if we proceed with 

a subsequent document, we will 

respond to the major comments in the 

preamble to that document. 

V. Regulatory Impact 

We have examined the impacts of this 

proposed rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review) and 

the Regulatory Flexibility Act 

(RFA)(September 19, 1980 Pub. L. 96–

354). Section 1102(b) of the Social 

Security Act, the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) and 

Executive Order 13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

annually). This proposed rule is an 

economically significant rulemaking 

under Executive Order 12866. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, nonprofit organizations, and government 

agencies. Most hospitals and most other 

providers and suppliers are small 

entities, either by non-profit status or by 

having revenues of $6 million to $29 

million in any one year. For purposes of 

the RFA, all OPOs are considered to be 

small entities. Individuals and States are 

not included in the definition of a small 

entity. 

In addition, 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. This analysis must conform to 

the provisions of section 603 of the 

RFA. For the 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 100 

beds.

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditure in 

any one year by State, local or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule does not impose substantial 

direct requirement costs on State or 

local governments and does not preempt 

State law or have other Federalism 

implications. 

Section 701 of Pub. L. 106–505, which 

was passed by Congress in 2000, 

requires us to promulgate regulations 

with new OPO outcome measures and 

to certify OPOs under those new 

measures by January 1, 2002. The new 

outcome and process performance 

measures must rely on empirical 

evidence, obtained through reasonable 

efforts, of organ donor potential and 

other related factors in each OPO’s 

service area. The regulations must 

include multiple outcome measures. 

All 59 OPOs would be affected by the 

requirements in this proposed rule to a 

greater or lesser degree. Many—

probably the majority—of OPOs have 

already put into practice many of the 

requirements we propose. However, 

OPO practices vary widely. Some 

requirements would impact many OPOs 

but have relatively little economic 

impact; others would have a larger 

economic impact but would impact very 

few OPOs. Thus, while we do not 

believe the requirements in this 

proposed rule would have a substantial 

economic impact on a significant 

number of OPOs, we believe it is 

desirable to inform the public of our 

projections of the likely effects of the 

final rule on OPOs. It is important to 

note that since OPOs are paid by the 

Medicare program on a cost basis, any 

additional costs that exceed an OPO’s 

annual revenues would be fully 

reimbursed by the Medicare program. 

Our projections are based largely on 

data and information provided by the 

CMS OPO Coordinators. Each 

Coordinator is responsible for the OPOs 

located in one of the four CMS 

Consortia areas (Midwest, West, South, 

and Northeast). In some cases, no data 

were available for one or more of the 

Consortia. However, OPO practices 

typically vary by size and affiliation 

(hospital-based or independent), rather 

than by geographic location. Since all 

types of OPOs are represented within 

each Consortium, we feel confident that 

the practices and experiences of the 

OPOs within two or three of the 

Consortia are representative of all OPOs. 

Therefore, where data were not 

available for all four Consortia, we 

based our projections on data from 

fewer than four. 

The provisions of this proposed rule 

would have a very limited economic 

impact on hospitals. It is expected that 

improved OPO performance would 

result from the rule and would increase 

organ donation and, therefore, the 

number of organs available for 

transplantation. However, transplant 

hospitals are reimbursed for their costs 

related to performing transplants, and 

donor hospitals are reimbursed by OPOs 

for the cost of maintaining potential 

donors. Therefore, there are no negative 

economic impacts on hospitals that 

would result from the rule. 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6121

Reason for This Regulation 

Approximately 70 people receive an 

organ transplant every day. However, 

another 16 die due to the lack of 

transplantable organs (http://

organdonor.org). OPOs play a critical 

role in securing transplantable human 

organs for seriously ill patients suffering 

from end-stage organ failure. In fact, 

OPO performance is one of the most 

critical elements in the nation’s organ 

transplantation system. An OPO that is 

effective in procuring organs and 

delivering them safely to transplant 

centers clearly will save more lives than 

an ineffective one. 

In passing the Organ Procurement 

Organization Certification Act of 2000, 

Pub. L. 106–505, Section 701, Congress 

made certain findings related to OPOs 

and the current re-certification process 

for OPOs. These findings included: 

a. Organ Procurement Organizations 

play an important role in increasing 

organ donation. 

b. The uncertainty that resulted from 

the Department of Health and Human 

Services’ current certification and 

recertification process was actually 

interfering with the OPOs’ effectiveness 

in increasing the level of organ 

donation. 

c. The limitations noted in the DHHS’

recertification process included: 

i. Sole reliance on population-based 

measures of performance that do not 

take into consideration a particular 

population’s organ donation potential.

ii. No allowance for other outcome 

and process standards that may more 

precisely reflect each OPO’s 

performance and potential. 

iii. Lack of a process to appeal for 

recertification on either procedural or 

substantive grounds to the Secretary of 

DHHS. 

The Organ Procurement Organization 

Certification Act required that the 

Secretary of DHHS promulgate 

regulations that incorporate certain key 

requirements. Those requirements have 

been incorporated into this proposed 

rule. 

Congress clearly wanted the Secretary 

to establish a certification process that 

would decrease the uncertainty inherent 

in the current CMS certification process 

and improve OPO performance. The 

goal was to increase organ donation and 

the number of transplantable organs 

available for persons experiencing organ 

failure. We believe that this proposed 

rule establishes certification and 

competition processes that will meet 

those goals. 

1. Feasible Alternatives for Competition 

Among OPOs for Service Areas 

Under this proposed rule, OPOs may 

compete for an OPO’s service if the OPO 

has been de-certified by CMS. OPOs 

may also compete for other OPOs’

service areas at the end of each 4-year 

re-certification cycle. OMB Circular A–

4 recommends that agencies explore 

modifications of some or all of a 

regulation’s attributes or provisions to 

identify appropriate alternatives. CMS 

believes that an important policy 

decision in this rulemaking is the level 

of competition that would be allowed 

between the OPOs. 

Three levels of competition were 

considered. We have defined these 

alternatives, some of which are also 

discussed in the preamble, as: 

a. Full Competition. Every OPO that 

has met the re-certification criteria 

would be eligible to compete for another 

OPO’s service area. 

b. Limited Competition. Only those 

OPOs that meet specific criteria would 

be allowed to compete for another 

OPO’s service area. 

c. Restricted Competition. The only 

competition allowed between OPOs 

would be for the service area of an OPO 

that had been de-certified by CMS. 

In this proposed rule, CMS has 

attempted to strike a balance between 

the costs of competition in terms of 

resource use and disruption of normal 

business operations and the benefits of 

competition, namely the ability of 

competition to improve performance 

and inspire innovative activity. 

Under this proposed rule, we would 

select an OPO to replace an incumbent 

OPO if, in our assessment, the OPO 

could significantly increase organ 

donation within that service area. This 

assessment would be based on the past 

performance of the competing OPOs and 

our assessment of the plans to increase 

organ donation submitted by each 

competing OPO. These plans would, at 

a minimum: 

a. Be based on the competing OPO’s 

experience in its own service area; 

b. Include an analysis of existing 

barriers to increasing organ donation in 

the open service area, both internal and 

external; and 

c. Contain a detailed description of 

specific activities and interventions for 

increasing organ donation in the open 

service area. 

Many factors can affect organ 

donation rates. For example, a service 

area might have a large elderly 

population, a low motor vehicle 

accident rate, or a high incidence of 

Human Immunodeficiency Virus/

Acquired Immune Deficiency Syndrome 

(HIV/AIDS). It is possible that cultural, 

ethnic, or racial factors may affect organ 

donation rates. For example, if there is 

a large immigrant population in a 

service area, there might be significant 

cultural and language barriers to 

donation. Therefore, an OPO that 

decided to compete for an open service 

area might need to perform significant 

research and data analysis to determine 

the barriers to increased organ donation 

in a particular service area. Once this 

analysis was completed, the OPO’s staff 

would have to develop a detailed 

description of specific activities and 

interventions for increasing organ 

donation in the open service area. 

Therefore, the development of an 

acceptable bid would require the 

diversion of staff resources from the 

OPO’s normal operations. 

Full Competition Under Existing 

Regulations 

Under the current Conditions for 

Coverage for OPOs, there was full 

competition for each service area at the 

end of each re-certification cycle (42 

CFR 486.316). OPOs that did not meet 

the performance standards were decertified and were not able to compete. 

Therefore, only OPOs that met the 

performance standards were permitted 

to compete for service areas. 

Benefits of this approach: All other 

things being equal, greater competition 

between OPOs should improve 

performance. If an OPO knows that it is 

in danger of losing its service area 

during the recertification process, it 

should have an incentive to perform 

well. This incentive would likely cause 

some OPOs to develop new, innovative 

practices.

Costs of this approach: As explained 

above, the process of competing for a 

service area involves the expenditure of 

resources. However, there would be 

little additional effort or resource 

expenditure for an incumbent OPO to 

compete for its own area. In addition, 

full competition is an adversarial 

process. This may adversely affect the 

current collaborative atmosphere that 

exists between the OPOs. 

Finally, full competition provides an 

opportunity for a minimally effective 

OPO to take over a failing OPO. 

Depending upon which OPOs competed 

for a particular service area, however, 

there is no guarantee that a winning 

OPO would have more than the 

minimum requirements to be recertified, and thus the winning OPO 

may be unable to improve donation in 

the service area. Therefore, we are not 

proposing that OPO service areas be 

opened to competition from all OPOs. 

We have not yet quantitatively analyzed 

6122 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

the costs and benefits from this full 

competition approach, but we will do so 

for the final rule. However, we are 

requesting comment on this and other 

approaches that allow for more intense 

competition than our preferred option. 

Limited Competition 

Under this option, all OPO service 

areas would be open to competition as 

under the full competition option; 

however, only those OPOs that met 

specific criteria would be allowed to 

compete for another OPO’s service area. 

The specific criteria used to designate 

which OPOs would be eligible to 

compete for another OPO’s service area 

would ensure that the competition was 

limited to OPOs that had demonstrated 

above average performance and that 

OPOs permitted to compete for open 

service areas would be measurably 

superior to the incumbent OPOs. 

Benefits of this approach: The intent 

of establishing competition between the 

OPOs is to improve the overall 

performance of OPOs by allowing above 

average OPOs to take over the service 

areas of poorly or marginally performing 

OPOs, and to allow OPOs to bid for 

areas in which they have the potential 

to significantly outperform the 

incumbent OPO. The intent is not to 

have OPOs competing against one 

another when there are only marginal 

differences between the OPOs. 

Therefore, we believe the specific 

criteria would have to establish a 

measurable differential. We have not yet 

quantitatively analyzed the costs and 

benefits from this limited competition 

approach, but we will do so for the final 

rule. However, we are requesting 

comments on this and other approaches 

that allow for more intense competition 

than our preferred option. 

Costs of this approach: Although 

limited competition would require 

fewer resources from OPOs, the 

competitive activities would require 

resources from OPOs that decide to 

compete for an open service area, 

especially a large amount of staff time. 

For OPOs competing for another OPO’s 

service area, these resources would be 

in addition to those used to improve an 

OPO’s performance in its existing 

service area. 

Although fewer OPOs would be 

involved with limited competition, it 

would still be an adversarial process. 

We anticipate that most OPOs would 

soon realize who their potential 

competitors were and this could 

adversely affect the current 

collaborative atmosphere that exists 

between many of the OPOs. Although 

this effect would be to a much lesser 

extent than with full competition, the 

collaborative atmosphere between some 

OPOs may be adversely affected by 

limited competition. 

Thus, limited competition offers the 

advantage of having a better performing 

OPO take over the service area of an 

incumbent OPO that is not performing 

as well. It also offers the advantage of 

setting specific criteria to ensure that 

the better performing OPO has the 

expertise to increase organ donation in 

another service area. This should result 

in increased organ donation in the 

competed service area. Further, while 

limited competition has disadvantages, 

those disadvantages can be minimized.

Restricted Competition 

Under this option, the only 

competition allowed between OPOs 

would be for the service areas of OPOs 

that had been de-certified by CMS. 

However, the competition would still be 

limited to OPOs that met specific 

criteria. The specific criteria would 

need to ensure that the competing OPOs 

were more than minimally performing 

OPOs. The intent would be to have an 

OPO that is performing measurably 

better than the de-certified OPO take 

over the service area. 

Benefits of this approach: Limiting 

competition in this way would restrict 

competition to areas in which the 

expectation of significant improvement 

in service could be met. In addition, 

fewer resources would be diverted from 

organ procurement itself to the 

competitive process. 

Costs of this approach: Clearly, 

restricted competition would severely 

limit the competition between OPOs. 

Only service areas of de-certified OPOs 

would be opened for competition. The 

service areas of minimally performing 

OPOs (that is, OPOs whose performance 

was only slightly above the performance 

of failing OPOs) would not be opened 

for competition from OPOs that had 

performed measurably better. Therefore, 

restricted competition could not 

improve organ donation in service areas 

of minimally performing OPOs. 

2. Competition for De-Certified OPO’s 

Service Area 

Our preferred option for competing 

service areas of de-certified OPOs is 

limited competition, as we feel this 

option best balances the benefits and 

costs of the competitive process. 

However, we are soliciting comments on 

this conclusion. We propose that a decertified OPO would not be allowed to 

compete. The competition would be 

limited to OPOs that met 4 out of 5 of 

the outcome performance measures at or 

above the mean in the preceding recertification cycle. We would select an 

OPO for the service area based on its 

success in meeting the process 

performance standards, as well as 

submission of an acceptable plan to 

increase organ donation in the service. 

By requiring an OPO to have attained 

the mean or greater in 4 out of 5 

outcome performance measures in the 

preceding re-certification cycle, we 

would limit competition to OPOs that 

had performed measurably better than 

the de-certified OPO. We believe such 

OPOs would have the expertise to take 

over a poorly performing OPO’s service 

area and improve organ donation. Also, 

our preferred competition process 

would require fewer resources from the 

OPOs than full competition, ensure 

timely completion of the competitive 

process, and minimize disruption to 

operations in service areas. 

3. Quadrennial Certification 

Competition 

For the quadrennial certification 

competition, our preferred option is also 

limited competition with the following 

characteristics. We propose that for an 

OPO to compete for an incumbent 

OPO’s service area, the competing OPO 

must have achieved at least 100 percent 

of the mean in 4 out of 5 outcome 

performance measures in the preceding 

re-certification cycle. In addition, the 

competing OPO’s conversion rate of 

potential donors to actual donors must 

be at least 15 percentage points above 

the incumbent OPO’s conversion rate 

for the preceding re-certification cycle. 

This option offers two clear 

advantages. First, the competition is 

limited to at least average performing 

OPOs because of the requirement that 

an OPO must have achieved at least 100 

percent of the mean in 4 out of 5 

outcome performance measures for the 

preceding re-certification cycle. Second, 

OPOs permitted to compete for open 

service areas would be measurably 

superior to the incumbent OPOs due to 

the requirement for an OPO to have a 

conversion rate at least 15 percentage 

points greater than the conversion rat of 

the incumbent. These advantages 

provide us with the assurance that a 

competing OPO would have the 

expertise needed to increase organ 

donation in an incumbent OPO’s service 

area. 

This option would restrict the number 

of OPOs that would be eligible to 

compete for another OPO’s service area. 

However, we anticipate that there 

would be a substantial number of OPOs 

that would qualify to compete. 

Under this option, it is possible that 

a superior performing OPO could 

compete for the service area of an above 

average performing OPO. For example, 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6123

an OPO that achieved 120 percent of the 

mean in 4 out of 5 outcome performance 

measures could compete for the service 

area of an OPO that achieved 105 

percent of the mean in 4 out of 5 

outcome performance measures. 

However, as long as the betterperforming OPO could significantly 

increase organ donation in the open 

area, we believe it would be worthwhile 

for the competition to take place.

In determining the necessary 

differential that would be required to 

allow competition we had two goals. 

The first was that we wanted the 

differential to be large enough to assure 

us that the competing OPO had the 

expertise to take over another service 

area and increase organ donation; in 

other words, we wanted the differential 

to reflect significant differences in 

performance. The second was that we 

wanted to minimize the disturbance to 

routine OPO operations that is inherent 

in the competition process. 

We believe that our proposed 15 

percentage point differential strikes the 

balance needed to achieve both of these 

goals. It is large enough to demonstrate 

that the competing OPO is performing 

measurably better than the incumbent 

OPO. It will also limit the competition 

to OPOs that we can reasonably expect 

will be able to take over another service 

territory and increase organ donation. 

Congress clearly intended that a 

competitive process would reduce 

uncertainty and result in improved 

performance by OPOs. We believe that 

such a competition would result in an 

increase in organ donation and the 

number of transplantable organs 

available for patients on the waiting list. 

We are specifically soliciting comment, 

however, on modifications within our 

chosen limited competition framework. 

These options are discussed below. 

Option 1

Under this option, an OPO competing 

for an open service area must have 

achieved at least 120 percent of the 

mean in 4 out of 5 outcome performance 

measures for the preceding recertification cycle. In addition, the 

competing OPO must have at least a 15 

percentage point conversion rate 

advantage over the incumbent OPO. 

That is, the competing OPO’s 

conversion rate of potential donors to 

actual donors (the first of the five 

performance measures) must be 15 

percentage points higher than the 

incumbent OPO’s conversion rate. 

This option would ensure that the 

competing OPO had above average 

performance and that its performance 

was measurably superior to the 

performance of the incumbent OPO. It 

also would provide us with the 

assurance that the competing OPO had 

the expertise to increase organ donation 

in the incumbent OPO’s service area. 

We are, however, concerned that this 

option would severely restrict 

competition among OPOs because we 

anticipate that few OPOs would meet 

120 percent of the mean for 4 out of 5 

performance measures. In addition, 

since most OPOs would probably be 

interested only in competing for service 

areas in their own geographical areas, 

this could result in virtually no 

competition in certain areas of the 

country. 

Option 2

As in the first option, option 2 would 

require that to compete for an 

incumbent OPO’s service area, the 

competing OPO must have at least a 15 

percentage point conversion rate 

advantage over the incumbent OPO for 

the preceding re-certification cycle. The 

advantage of this option is that the 

competing OPO would be required to 

demonstrate that it had performed 

measurably better than the incumbent 

OPO. While a variation of a few points 

would not be a reliable indicator of an 

OPO’s superior quality, we believe a 15 

percentage point advantage in 

conversion rate is a large enough 

difference to assure us that the 

competing OPO’s performance is 

actually superior to the incumbent 

OPO’s performance. 

However, this option would not 

require an OPO to have achieved a 

certain level of performance in the 

outcome performance measures during 

the prior re-certification cycle. Thus, we 

are concerned that a 15 percentage point 

advantage is an insufficient criterion to 

determine whether or not a competing 

OPO has the expertise to perform 

measurably better in the incumbent 

OPO’s service area because, under this 

option, an OPO that is a below average 

performer could compete for the service 

area of a poorly performing OPO. For 

example, an OPO that achieved 90 

percent of the mean in 4 out of 5 

outcome performance measures would 

be permitted to compete for a service 

area in which the incumbent OPO 

achieved 75 percent of the mean in 4 

out of 5 outcome performance measures. 

While the 15 percentage point 

difference indicates that the competing 

OPO is measurably superior to the 

incumbent OPO, it does not require that 

the OPO is at a minimum an average 

performer.

We are concerned about an OPO with 

below average performance competing 

for the service area of another OPO 

because we do not believe that a OPO 

that is performing below average in its 

own service area would have the 

expertise needed to increase organ 

donation in another OPO’s service area, 

especially when the incumbent is 

performing poorly. 

In addition, the competitive process 

itself causes disturbance in the 

operations of both the competing and 

incumbent OPOs. Each must develop an 

acceptable plan for the competition. 

This requires resources from both OPOs 

that may have to be diverted from their 

routine operations, as well as from their 

efforts to increase organ donation in 

their service areas. In order to justify the 

disruption to OPO operations, there 

should be some assurance that the 

competing OPO would be able to 

increase organ donation in the 

incumbent OPO’s service area. With 

only a 15 percentage point difference 

and no requirement that the competing 

OPO be a good performer, we would not 

feel confident that the competing OPO 

would have the expertise needed to 

increase organ donation in the 

incumbent OPO’s service area. 

Therefore, we believe that if the 

competing OPO is not at least an 

average performer, the potential for a 

slight improvement in the service area 

would not justify this disruption to the 

service area. 

We also are requesting comments on 

the option of restricted competition. 

Under this option, the only competition 

allowed between OPOs would be for the 

service areas of OPOs that had been decertified by CMS. The competition 

would be limited to OPOs that met 4 out 

of 5 performance measures at 100 

percent of the mean or greater. These 

specific criteria would ensure that the 

competing OPOs were more than 

minimally-performing OPOs and that 

they were performing measurably better 

than the de-certified OPO. 

Under this option, fewer resources 

would be diverted from organ 

procurement itself to the competitive 

process, and collaboration among OPOs 

would not be disturbed. However, this 

option would not allow for competition 

for the service areas of OPOs that only 

barely met the qualifications for recertification. 

Cost-Effectiveness and Cost-Benefit 

Analysis of Preferred Option 

Our proposed criteria for selecting a 

competing OPO are success in meeting 

the process performance measures 

during the prior re-certification cycle 

and an acceptable plan to increase organ 

donation in the open service area. The 

minimum requirements for an 

acceptable plan would be: 

6124 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

• Demonstrate the competing OPO’s 

experience in its own service area; 

• Include an analysis of existing 

barriers to increasing organ donation in 

the open service area, both internal and 

external; and 

• Provide a detailed description of 

specific activities and interventions for 

increasing organ donation in the open 

service area. 

We feel that it would take a 

competing OPO approximately 16 hours 

to develop an acceptable plan. A 

competing OPO would need to assess 

the incumbent OPO’s service area, 

determine the reasons for or the factors 

that affected the incumbent’s 

performance, develop an analysis of the 

existing internal and external barriers to 

increasing organ donation in the service 

area, determine the specific activities 

and interventions the competing OPO 

can perform to increase organ donation, 

and finally, prepare and submit the 

plan. 

CMS has not yet fully analyzed the 

costs and benefits of the alternatives 

presented above. We expect that the 

costs per bid assumed in this analysis 

will be roughly linear as the number of 

bids increases or decreases based on the 

allowed level of competition; however, 

the costs of preparing a bid may depend 

on local variation in labor rates. We 

expect that the benefits of competition 

are not linear; under limited 

competition, CMS would limit bids only 

to those situations where we expect that 

competition will be especially 

successful in improving performance. 

We expect that the marginal returns to 

competition are greater for the more 

restrictive limited competition options, 

and that the marginal returns to 

competition diminish as the options 

become more permissive. CMS plans to 

fully analyze the costs and the benefits 

of the competitive process in the final 

rule.

Under the statute and current OPO 

regulations, OPOs must be members of 

and abide by the rules of the OPTN (as 

defined in § 486.320); therefore, there is 

no additional burden associated with 

this condition. 

Current OPO regulations require 

OPOs to have a board of directors or an 

advisory board with a specific 

membership composition. The 

condition for administration and 

governing body in this proposed rule 

might require an OPO to add one 

additional member to its board. If the 

tissue banks in the OPO’s service area 

currently are represented on the board 

by the OPO’s own tissue bank, the OPO 

would be required to add a member 

from a tissue bank that is not affiliated 

with the OPO. This condition would 

also require OPOs to have bylaws to 

address potential conflicts of interest, 

length of terms, and criteria for selection 

and removal of board members. It 

requires an individual or a governing 

body to have full legal authority and 

responsibility for management and 

provision of all OPO services, including 

development and implementation of 

policies and procedures for 

administration of the OPO. 

The economic impact to add a tissue 

bank member to an OPO board would be 

negligible because OPOs generally do 

not pay board members for their 

services. The economic impact on OPOs 

that do not have bylaws for their boards 

addressing conflicts of interest, length of 

terms, and criteria for selection and 

removal of board members would be the 

cost of developing such bylaws. The 

extent of the impact would depend on 

the process used to develop the bylaws. 

For example, at some OPOs, it is likely 

an executive committee of the board 

would develop bylaws for approval by 

the entire board. This process would 

result in little or no cost to the OPO 

because the bylaws would be developed 

by unpaid board members. However, 

other OPOs might include the OPO 

director in the development of the 

bylaws. In this case, there would be a 

cost to the OPO, based on the number 

of hours needed to develop the bylaws 

and the director’s salary. We do not 

expect that development of bylaws 

would take more than a few hours, since 

information and advice regarding 

development of bylaws would be 

available from OPOs that already have 

bylaws in place for their boards. 

It appears that about 70 percent of 

OPOs do not have bylaws for their 

boards addressing conflicts of interest, 

and approximately 22 percent do not 

have bylaws addressing length of terms 

and criteria for selection and removal of 

board members. This would mean that 

approximately 18 OPOs would need to 

develop bylaws addressing conflicts of 

interest, and approximately 46 would 

need to develop bylaws addressing 

length of terms and criteria for selection 

and removal of board members. Thus, 

under this proposed rule, OPOs would 

need to write 64 sets of bylaws for their 

boards of directors. 

In one CMS Consortium, OPO 

Directors’ salaries range from 

approximately $80,000 to more than 

$130,000. To estimate the economic 

impact, we assumed that all OPOs 

would choose to have their directors 

participate in developing bylaws for 

their boards, and that the development 

of each set of bylaws would take 8 hours 

of an OPO director’s time. If every 

director made $105,000 per year 

(approximately $50 per hour), it would 

cost an OPO $400 to develop a set of 

bylaws, for a total of $25,600 to develop 

64 sets of bylaws. We expect that most, 

if not all, OPOs currently have an 

individual or governing body legally 

responsible for management and 

provision of OPO services. Therefore, 

we do not expect that there would be a 

cost to OPOs to implement this 

provision of the regulation. 

It is extremely difficult to quantify the 

costs for OPOs of meeting the 

requirements for human resources. The 

human resources condition would 

require every OPO to have a medical 

director, although it would not specify 

that the medical director must be full 

time. We believe all OPOs have medical 

directors, because the OPTN states that 

OPOs must have medical directors who 

are licensed physicians and who are 

responsible for medical and clinical 

activities of the OPO. However, our 

proposal would require the medical 

director to be involved in the day-to-day 

operations of the OPO because he or she 

would be responsible for 

implementation of protocols for donor 

evaluation and management and organ 

placement and recovery, as well as 

assisting in management of donor cases 

if the surgeon on call were unavailable. 

We believe that nearly all OPOs have 

a full-time medical director or one or 

more part-time directors whose 

responsibilities include implementation 

of protocols for donor evaluation and 

management and organ placement and 

recovery and who assist in the 

management of donor cases if the 

surgeon on call is unavailable. These 

OPOs would already meet the 

requirements of the proposed rule. In 

fact, we believe that every OPO in two 

of the CMS Consortia already fully meet 

this proposed requirement. However, in 

a very small number of OPOs, medical 

directors are not actively engaged in 

OPO operations; their participation may 

be limited to consulting and attending 

board meetings. 

It is difficult to quantify the cost to 

these few OPOs of meeting the proposed 

requirement because the cost to an 

individual OPO would be dependent on 

whether the OPO needed to hire a fulltime medical director, hire one or more 

additional part-time medical directors, 

or increase the hours of an existing 

medical director, and to what extent. 

Furthermore, salaries of medical 

directors vary widely. Some local 

transplant surgeons who serve as parttime OPO medical directors do not 

accept a salary for the services they 

provide to the OPO; other part-time 

medical directors are paid up to 

$100,000 per year. A full-time medical 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6125

director may be paid less than $100,000 

or as much as $250,000 annually. 

To estimate the economic impact of 

the medical director requirement, we 

assumed that 10 percent of OPOs (6 

OPOs) would need to hire a part-time or 

full-time medical director or increase 

the hours of an existing director and 

that, on average, each of these OPOs 

would need a medical director for an 

additional 20 hours per week. If the 

OPOs reimbursed the medical directors 

based on a rate of $125,000 annually, it 

would cost each OPO $62,500, and the 

total economic impact would be 

$375,000.

We are also proposing to require an 

OPO to maintain sufficient staff to carry 

on essential OPO activities, such as 

answering hospital referral calls in a 

timely manner and providing 

information and support to potential 

donor families. Most OPOs have 

sufficient staffing to carry on essential 

activities; to the extent that they do not, 

this rule would require them to hire 

additional staff. However, the impact on 

individual OPOs would vary, depending 

upon their situations. For example, all 

OPOs in one CMS Consortium appear to 

have sufficient staff to carry on essential 

activities. In another Consortium, all but 

two OPOs have sufficient staff. These 

two OPOs are adding staff based on 

comparative data from successful OPOs 

and from the AOPO Annual Report and 

expect to be staffed fully by mid-2004. 

However, in a third Consortium, slightly 

more than half of the OPOs most likely 

would need one or two procurement 

coordinators or other professionals in 

order to have sufficient staff. 

Most staff carrying on what would be 

considered ‘‘essential’’ activities (for 

example, procurement, hospital 

development, and screening of referral 

calls) have a medical background. 

Procurement coordinators are usually 

registered nurses (RNs), but sometimes 

they are social workers. In 2000, the 

median annual income of an RN was 

$44,840, and the median annual income 

of medical and public health social 

workers was $40,020. We have observed 

that procurement coordinators generally 

earn about $40,000 to $45,000 to start. 

Hospital development staff are 

sometimes RNs and sometimes 

individuals with public relations 

backgrounds. In 2000, public relations 

managers had a median annual income 

of $54,540. Sometimes OPOs’ hospital 

development and procurement staffs 

screen referral calls; however, OPOs 

may hire other individuals to screen 

calls, such as medical and nursing 

students or emergency medical 

technicians. In 2000, emergency 

medical technicians had a median 

annual income of $24,460. 

We estimate that 10 percent of OPOs 

(6 OPOs) would need to add one 

additional professional staff person and 

5 percent (3 OPOs) would need to hire 

2 additional staff, for a total 12 

additional staff. (This estimate includes 

additional staff needed to meet all 

proposed requirements except the QAPI 

requirements, which are discussed later 

in this preamble.) If each staff person 

was paid $45,000, the total economic 

impact would be $540,000. 

The human resources condition also 

would require OPOs to provide the 

education, training, and supervision to 

their staffs necessary to furnish required 

services. We have found that OPOs 

generally offer three types of staff 

education and training, depending upon 

the size and resources of the OPO: (1) 

On-the-job-training; (2) in-depth 

training provided within the OPO, 

sometimes using a modular training 

structure; and/or (3) classroom training 

that, in some cases, leads to certification 

in procurement and transplantation. 

Costs for training vary widely; 

however, we have found that good staff 

training need not be expensive. OPOs 

provide no-cost training to each other, 

in the form of on-site training sessions 

in hospital development, as well as 

opportunities for staff details and 

‘‘shadowing’’ of staff at high-performing 

OPOs. UNOS Regional Forums, which 

are held once or twice per year in the 

11 UNOS Regions, provide 

opportunities for staff training at a low 

cost (for example, $75 per day). Since 

the training is held within the UNOS 

Region, travel costs are kept to a 

minimum. Two OPOs in one of the CMS 

Regional Consortia have elected to use 

modular training with demonstration 

and examination required to move to 

the next level. Training will be provided 

to all new and existing OPO 

professional staff; the cost is estimated 

at $5000 per OPO. Some OPOs send 

their procurement coordinators for 

training provided by the North 

American Transplant Coordinators 

Organization, which costs 

approximately $1000 to $1500 per 

coordinator.

If we estimate that 25 percent of OPOs 

(approximately 15 OPOs) would need to 

provide additional education and 

training to their professional staff in 

order to meet the requirements of the 

proposed rule, and all 15 chose to use 

in-depth modular training within the 

OPO, the cost to each OPO would be 

approximately $5,000, and the total cost 

for all 15 OPOs would be $75,000. 

The human resources condition 

would require an OPO to have a written 

policy to address potential conflicts of 

interest for its director, medical director, 

senior management, and procurement 

coordinators. Although we expect that 

most OPOs have written policies in 

place, we know that some OPOs do not. 

If an OPO had to develop such a policy, 

it is likely it would be developed by the 

OPO director and would take 

approximately 8 hours. If the director is 

paid $105,000 annually (approximately 

$50 per hour), the cost to the OPO 

would be approximately $400. If 25 

percent of OPOs (approximately 15 

OPOs) needed to develop such bylaws, 

the total economic impact would be 

$6000. 

The human resources condition also 

would require OPOs to maintain 

credentialing records for physicians and 

other practitioners who routinely 

recover organs in donor hospitals with 

which the OPO has agreements and 

ensure that all physicians and other 

practitioners who recover organs in 

hospitals are qualified and trained. We 

have been told by OPOs that most, if not 

all, OPOs have some type of process to 

ensure that physicians and other 

practitioners who recover organs are 

qualified. 

In most cases, organs are recovered by 

transplant surgeons from the hospital 

that will perform the transplant or by 

physicians or technicians employed by 

or under contract with OPOs. OPOs that 

do not have a process to ensure that 

physicians and other practitioners are 

qualified and trained would incur some 

costs to put a process into place. An 

OPO would incur a cost for the staff 

time needed to request and review 

credentialing records for transplant 

surgeons and to request and review 

documentation of the qualifications of 

other recovery personnel. 

We estimate that requesting and 

reviewing a record would take no more 

than 15 minutes. There are 

approximately 270 hospitals in the 

United States with transplant programs. 

Thus, each of the 59 OPOs has, on 

average, about five transplant hospitals 

in its service area. If each hospital has 

20 surgeons who recover organs, an 

OPO would have to request and review 

approximately 100 records. Presuming 

this activity was performed by an OPO 

medical director making $125,000 per 

year ($60 per hour), the cost to the OPO 

for the medical director to spend 25 

hours reviewing 100 records would be 

$1500. If we estimate that 10 percent of 

OPOs (approximately 6 OPOs) will need 

to perform this activity, the total cost 

would be $9000. 

We have not assigned a cost for an 

OPO to request and review records for 

physicians or other recovery personnel 

6126 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

who work for or are under contract to 

the OPO because we assume the OPO 

would perform those activities in the 

normal course of business. Likewise, we 

have not assigned a cost for activities 

associated with ensuring the 

qualifications and training of physicians 

and other recovery personnel from 

outside an OPO’s service area. The time 

needed to verify qualifications and 

training of these recovery personnel, 

who only occasionally recover organs in 

an OPO’s service area, would be 

minimal and could be accomplished by 

contacting a transplant hospital to 

confirm that a surgeon who will recover 

an organ at one of the OPO’s hospitals 

is credentialed and has privileges at the 

transplant hospital. 

The current OPO regulations require 

OPOs to maintain donor records with 

specific data elements, although there is 

no requirement for how long the records 

must be kept. The proposed information 

management condition would require 

OPOs to include specific data elements 

in their records and maintain their 

records for 7 years. We do not anticipate 

a significant burden associated with this 

requirement because, the final rule 

governing the operation of the OPTN 

state that OPOs must maintain donor 

records for 7 years; thus, we expect 

OPOs already meet the proposed 

requirement.

The condition for reporting of data 

specifies that an OPO must provide 

organ donation and transplantation data 

as requested by the OPTN, the SRTR, 

and transplant hospitals. Additionally, 

the OPO would be required to provide 

data and other information directly to 

the Department as requested by the 

Secretary. The current regulations 

require only that OPOs report five 

performance data elements to us 

annually and ‘‘maintain and make 

available to CMS, the Comptroller 

General, or their designees data that 

show the number of organs procured 

and transplanted.’’

Although it appears this requirement 

has the potential to add a significant 

new reporting burden, OPOs already 

report a large amount of data to the 

OPTN (which, in turn, provides the data 

to the SRTR for analysis). For example, 

the cadaver donor registration form that 

OPOs are required to complete for each 

donor contains more than 300 data 

elements. Further, regulations governing 

the operation of the OPTN at 42 CFR 

121.11(b)(2) require OPOs, as specified 

by the Secretary, to submit data to the 

OPTN. Thus, most information needed 

by the OPTN, the SRTR or the Secretary 

would already be reported by OPOs. 

Although it is impossible to quantify 

the impact of the data reporting 

requirement, as data would be requested 

on an as-needed basis, we believe that 

almost any OPO data needed by us or 

other agencies within the Department 

could be obtained from the OPTN or the 

SRTR. We are including this provision 

only to give us and other agencies the 

flexibility to request data from OPOs in 

the event that needed data cannot be 

obtained expeditiously from the OPTN 

or the SRTR. We would not request data 

from OPOs if the data were readily 

available from other sources. 

However, we can quantify the impact 

on OPOs of reporting the four hospitalspecific data elements they currently 

report voluntarily to the OPTN (that is, 

referrals, medically suitable potential 

donors, consents, and donors). All 59 

OPOs have the capability of reporting 

data to the OPTN electronically. HRSA 

estimates that reporting the four data 

elements takes OPOs about 1 hour per 

month. If the data are entered by a data 

coordinator earning $40,000 per year 

(approximately $19.25 per hour), the 

cost to the OPO would be approximately 

$231 annually, for a total cost for all 59 

OPOs of approximately $13,629. 

At the recommendation of the OIG, 

we are including a requirement for 

OPOs to report hospital-specific 

donation data to the public. More than 

90 percent of OPOs publish newsletters 

and annual reports to inform the public 

of their activities, and, most likely, 

OPOs will report the hospital data in 

their newsletters and annual reports at 

very little additional cost. Since all 59 

OPOs maintain Internet sites, they could 

include the hospital data on their sites 

at a negligible cost. 

There are provisions in the proposed 

condition for OPOs’ relationships with 

hospitals that do not appear in our 

current regulations for OPOs. First, the 

condition would require an OPO to have 

written agreements with 95 percent of 

the hospitals and critical access 

hospitals in the OPO’s service area 

(unless a hospital has a waiver to work 

with another OPO) that have both a 

ventilator and an operating room. We 

expect that OPOs already have 

agreements with all Medicare and 

Medicaid hospitals in their service areas 

(unless a hospital in the service area has 

a waiver to work with another OPO) 

because the hospital and critical access 

hospital CoPs for organ, tissue, and eye 

procurement (see 42 CFR 482.45 and 

485.643), require Medicare and 

Medicaid participating hospitals and 

critical access hospitals to have an 

agreement with an OPO. We have found 

that most agreements between OPOs 

and hospitals are ‘‘generic’’ in nature 

and do not specify the OPO and hospital 

roles in the donation process. However, 

we propose requiring OPOs to address 

the responsibilities of both the OPO and 

the hospital in implementing § 482.45 

and § 485.643 and include definitions 

for the terms ‘‘imminent death’’ and 

‘‘timely referral.’’

Many OPOs would be required to 

rewrite their agreements; however, we 

expect OPOs would develop a standard 

agreement that addresses OPO and 

hospital responsibilities and defines 

‘‘imminent death’’ and ‘‘timely death’’

and would ask each of their hospitals to 

sign the standard agreement. We 

estimate that it would take an attorney 

8 hours to draft a new standard 

agreement that the OPO could present to 

each hospital. The average hourly wage 

for an attorney is $40; therefore, the cost 

to the OPO would be $320. The total 

cost for all 59 OPOs to have a new 

standard agreement drafted would be 

$18,880.

The average OPO has approximately 

100 hospitals in its service area. Based 

on past experience, we expect that 

between 50 percent and 67 percent of 

the hospitals in an OPO’s service area 

would sign the standard agreement with 

no changes. With few exceptions, the 

remainder of the hospitals would sign 

the agreements after a minimal amount 

of negotiation. If 50 hospitals (50 

percent of the 100 hospitals in an OPO’s 

service area) requested changes in the 

agreement before signing, and it took the 

OPO’s attorney 2 hours per agreement to 

make the changes, it would cost the 

average OPO $4000. The total cost for 

all OPOs to make changes in their 

agreements with hospitals would be 

$236,000. 

The condition also would require 

OPOs to offer annual designated 

requestor training to hospital and 

critical access hospital staffs. Although 

the hospital and critical access hospital 

CoPs give OPOs the responsibility for 

offering or approving designated 

requestor training for hospitals, very few 

OPOs have actually provided a 

significant amount of training to their 

hospitals. In fact, an August 2000 OIG 

report (Medicare Conditions of 

Participation for Organ Donation: An 

Early Assessment of the New Donation 

Rule) criticized OPOs for not providing 

more designated requestor training. 

Therefore, complying with this 

proposed requirement may add some 

costs for an OPO that has provided little 

or no designated requestor training if 

hospitals and critical access hospitals in 

its service area respond positively to the 

OPO’s offer to provide training. 

However, we do not anticipate a 

significant economic impact because 

most hospitals cannot spare staff to 

attend training in the entire consent 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6127

process and prefer to have their OPO 

handle most of the consent process. 

Additionally, although many hospital 

staff act as designated requestors in a 

supportive or collaborative role, we 

expect training for the supportive or 

collaborative role to be significantly less 

extensive (and therefore less costly) 

than training hospital staff for a 

requestor role. For example, complete 

designated requestor training might last 

for 4 to 8 hours, whereas, supporter or 

collaborator training might last for 2 

hours or less. Designated requestor 

training also may be provided through 

the use of a videotape. At least one OPO 

provides designated requestor training 

over the Internet. 

Generally OPO hospital development 

staff (who are likely to earn about 

$45,000 per year) provide designated 

requestor training in hospitals. If the 

average training session lasts 4 hours 

and is given at a hospital located 20 

miles from the OPO, the total cost of a 

training session (including salaries for 

two trainers for preparation, travel, and 

training time; mileage; and preparing 

and printing training packets) would be 

approximately $300. Based on our 

experience, we expect that nationwide, 

approximately 75 hospitals might 

request designated requestor training. 

Thus, the total economic impact would 

be approximately $22,500, with an 

average of less than $400 per OPO. 

An OPO would be required to have 

arrangements to cooperate with tissue 

banks that have agreements with 

hospitals with which the OPO has 

agreements. OPOs would be required to 

cooperate in screening and referring 

potential tissue donors, obtaining 

informed consent on behalf of tissue 

banks, and in the retrieval, processing, 

preservation, storage, and distribution of 

tissues. Most OPOs already have 

arrangements with the tissue banks in 

their service areas that address such 

issues as screening and referral of tissue 

donors. We are proposing this 

requirement to address situations in 

which an OPO has refused to have an 

arrangement with the tissue bank 

selected by the hospital.

There are approximately 300 tissue 

banks in the United States (166 

conventional tissue banks and 134 eye 

banks) or approximately 5 tissue banks 

per OPO service. In many service areas, 

the OPO owns or is affiliated with one 

of the tissue banks. In nearly all service 

areas, OPOs have arrangements with all 

tissue banks that have agreements with 

the hospitals in the service area. Based 

on our experience, we would expect 

that fewer than 5 percent of tissue banks 

(15 tissue banks) that do not have 

arrangements with an OPO would 

request an arrangement. 

If an OPO and tissue bank elected to 

have a written agreement, we would 

expect that the cost to the OPO of 

preparing the written agreement and 

making any changes negotiated with the 

tissue bank would be similar to the costs 

of preparing and making changes to a 

written agreement between an OPO and 

a hospital (that is, a one-time cost to the 

OPO of $320 for preparing an 

agreement, and an additional cost of $80 

to make changes). However, unlike 

hospital agreements which could be 

standardized, we would assume that 

OPO/tissue bank agreements would be 

individualized, since it is unlikely that 

more than one tissue bank in an OPO’s 

service area would request an 

arrangement. Therefore, the total cost of 

preparing each agreement and making 

changes would be $400, and the cost of 

preparing agreements with 15 tissue 

banks would be $6000. 

For several reasons, we do not believe 

the proposed requirement to have a 

QAPI program will have a significant 

impact on a large number of OPOs. 

First, as stated earlier in this preamble, 

most OPOs have a QAPI-type program 

(although not all programs are 

sufficiently comprehensive to meet the 

requirements of the proposed 

regulation). Second, AOPO is actively 

encouraging all OPOs to expand and 

improve their programs; in fact, AOPO 

recently added the development of a 

quality improvement program to their 

requirements for AOPO accreditation, 

although the new requirements will be 

phased in over 3 years. Third, in 

November 2001, AOPO surveyed OPOs 

to assess its programs and found that 43 

percent of the 35 OPOs that responded 

had designated a staff person whose 

primary job responsibility was 

coordinating and monitoring quality 

improvement. We have reason to believe 

this percentage would be much higher 

if the survey were performed today. 

Since AOPO conducted their survey, the 

majority of the OPO community has 

embraced continuous quality 

improvement and taken steps to 

integrate quality improvement into their 

core business structure.

Additionally, there are numerous lowcost or no-cost resources available to 

OPOs to develop QAPI programs, 

including the Breakthrough 

Collaborative, assistance from CMS OPO 

Coordinators, and the AOPO Quality 

Council. While we know that some 

OPOs will be impacted by the proposed 

QAPI requirement, we do not expect the 

impact to be significant because, at this 

time, all OPOs appear to be working 

toward developing a comprehensive 

QAPI program. 

We believe it is likely that 

approximately 20 percent of the 59 

OPOs (12 OPOs) would need 1⁄2 of a 

full-time equivalent (FTE) position to 

bring their QAPI programs into 

compliance with the requirement, and 

15 percent (9 OPOs) would need 1 FTE. 

An OPO would be likely to use an 

experienced individual from its hospital 

development or procurement staff, and 

we estimate that the individual would 

be paid approximately $50,000 

annually. Thus, the cost to each of the 

12 OPOs that would need to add 1⁄2 of 

an FTE would be approximately $25,000 

per year, and the cost to each of the 9 

OPOs that would need to add a full FTE 

would be $50,000 per year, for a total 

cost of $750,000. 

In addition, the proposed requirement 

for QAPI would require an OPO to 

perform death record reviews in every 

Medicare and Medicaid hospital in its 

service area that has 150 or more beds 

or a level I or level II trauma center, 

with the exception of rehabilitation or 

psychiatric hospitals. Based on our 

experience, all OPOs routinely perform 

death record reviews in hospitals they 

consider to have significant donor 

potential, but an OPO’s definition of 

‘‘significant donor potential’’ may not 

encompass as many hospitals as the 

requirement in the proposed rule. To 

the extent that it does not, the OPO 

might need to increase staff hours to 

perform the additional death record 

reviews. We estimate that 

approximately 20 percent of OPOs (12 

OPOs) may need to add 1⁄2 of an FTE in 

order to expand the number of hospitals 

in which it performs death record 

reviews. It is likely the death record 

reviews would be performed by RNs 

earning approximately $45,000 per year, 

thus the cost to an OPO of adding 1⁄2 of 

an FTE to perform death record reviews 

would be approximately $22,500. The 

total economic impact for all 12 OPOs 

would be $270,000. 

The proposed rule requires that an 

OPO’s QAPI program include a written 

policy to address adverse events. We 

estimate that about 90 percent of OPOs 

(53 OPOs ) would need to develop a 

written adverse event policy and that 

development of the policy would 

require 40 staff hours. We expect that 

the policy would be developed by 

professional staff, including 

procurement coordinators, medical 

directors, and OPO directors. We 

estimated an annual salary of $45,000 

(approximately $22 per hour) for a 

procurement coordinator, $125,000 

(approximately $60 per hour) for a 

medical director, and $105,000 

6128 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

(approximately $50 per hour) for an 

OPO director, and we averaged the three 

hourly rates to arrive at a cost of $44 per 

staff hour to develop an adverse event 

policy. Therefore, the cost to one OPO 

of developing an adverse event policy 

would be $1760 for 40 hours of work. 

The total cost to all 53 OPOs that would 

need to develop such policies would be 

$93,280. 

The condition for requesting consent 

will have little impact on OPOs. We 

believe all OPOs have policies for 

obtaining informed consent and provide 

training to their staffs in the informed 

consent process. Under the proposed 

conditions, some OPOs may have to 

broaden their informed consent policies, 

but there will be little resultant 

economic impact. 

The proposed rule would require 

OPOs to have written protocols for 

donor evaluation and management and 

organ placement and recovery that meet 

current standards of practice and are 

designed to maximize organ quality and 

optimize the number of donors and the 

number of organs recovered and 

transplanted per donor. Based on our 

experience, all OPOs have written 

protocols for donor evaluation and 

management and organ placement and 

recovery. The OPTN also has model 

protocols OPOs can follow for 

evaluation and management of potential 

donors. Some OPOs might need to 

update or change their protocols 

somewhat to meet the proposed 

requirements, but we believe the cost to 

individual OPOs would be negligible.

The condition for donor evaluation 

and management and organ placement 

and recovery requires the medical 

director from the OPO to be responsible 

for ensuring that the OPO has written 

protocols for donor evaluation and 

management and for ensuring the 

implementation of the protocols for 

each donor. Costs related to hiring or 

increasing the hours of a medical 

director are discussed as part of the 

human resources condition. 

This condition also requires OPOs to 

establish protocols in collaboration with 

transplant programs that define the roles 

and responsibilities of the OPO and the 

transplant program. It appears that all 

OPOs have some type of agreement or 

arrangement with the transplant centers 

in their service areas, but often these 

agreements or arrangements are 

informal in nature. Based on our 

experience, we expect that developing a 

protocol with a transplant center as 

required under the proposed rule would 

take approximately 10 hours. There are 

approximately 824 transplant programs 

in the U.S.; therefore, each of the 59 

OPOs has approximately 14 transplant 

programs in its service area. If it took an 

OPO medical director 10 hours to 

develop a protocol with a transplant 

center and the medical director earned 

a salary of $125,000 annually 

(approximately $60 per hour), it would 

cost an OPO $600 for development of a 

single protocol and a total of $8400 to 

develop 14 protocols. (We assume that 

each protocol would be individualized.) 

If we assume that 70 percent of the 59 

OPOs (41 OPOs) needed to develop 

protocols, the total economic impact 

would be $344,400. 

We foresee little economic impact 

from the proposed requirements in the 

condition for organ preparation and 

transport. We believe nearly all OPOs 

follow appropriate standards of practice 

for testing and tissue typing of organs. 

Developing and following a protocol for 

packaging, labeling, handling and 

shipping of organs can be done at very 

little added cost. For example, the cost 

of additional supplies for labeling inner 

and outer packaging of organs with the 

donor blood type would be negligible.

Our estimates of the economic impact 

on OPOs to meet the requirements in 

this proposed rule are as follows. 

• $25,600 to develop bylaws for OPO 

boards 

• $375,000 annually for medical 

director salaries 

• $540,000 annually for additional 

staff to meet human resources 

requirements 

• $75,000 initial cost for staff training 

• $6,000 to develop bylaws for OPO 

directors and other management staff 

• $9,000 to develop credentialing 

records for recovery staff 

• $13,629 annually to report data 

• $18,880 to develop hospital 

agreements 

• $22,500 for designated requestor 

training 

• $6,000 to develop arrangements 

with tissue banks 

• $750,000 annually for QAPI staff 

• $270,000 to perform death record 

reviews 

• $93,280 to develop an adverse event 

policy 

• $344,400 to develop protocols with 

transplant centers. 

Summary of Direct Cost 

Therefore, the first-year economic 

impact would be $2,549,289, and the 

average first-year cost to each of the 59 

OPOs would be $43,208. 

Benefits 

The primary economic impact of this 

proposed rule would lie with its 

potential to increase organ donation. 

However, it is nearly impossible to 

predict what that impact will be. 

Although many in the donation organ 

community believe that little can be 

done to increase the number of deceased 

donors, we would note that in 1998, the 

year in which the hospital CoP (see 

§ 482.45) went into effect, organ 

donation increased by nearly 6 percent. 

Therefore, we estimate that by 

increasing OPOs’ efficiency and 

adherence to continuous quality 

improvement measures, the provisions 

of this proposed rule could increase the 

number of organ donors by as much as 

3 percent per year, resulting in an 

additional 180 donors in the 

regulation’s first year. Based on 2000 

data for the number of organs 

transplanted per donor (2.87), a 3 

percent increase would result in 

approximately 517 additional 

transplants in the first year after 

implementation of the regulation. 

Transplants are performed both to 

save lives and to improve the quality of 

recipients’ lives. For end-stage renal 

disease patients, dialysis is an 

alternative to transplantation for 

extended periods of time. Nevertheless, 

physical health while on dialysis is 

significantly impaired, and dialysis 

imposes major stresses and substantial 

inconveniences in carrying out normal 

activities. Therefore, while for most 

patients, kidney transplantation is not 

necessary for survival, it significantly 

improves the quality of the transplant 

recipient’s life. For all other organs, a 

transplant is, in most cases, necessary 

for survival. 

Of the 17,219 transplants from 

deceased donors performed in 2000, 

slightly less than half (46.7 percent), or 

8,040, were kidney transplants. Thus, 

we estimate that in the first year, this 

regulation could result in approximately 

241 (46.7 percent of 517 transplants) 

lives vastly improved by kidney 

transplants and 276 (53.3 percent of 

517) lives both vastly improved and 

prolonged by transplantation of other 

major organs. 

The following reasoning was used to 

construct an estimate of the benefits of 

this proposed rule. It is common, in cost 

benefit analysis, to use a concept termed 

‘‘value of a statistical life’’ (VSL) 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 those reductions. 

For purposes of our cost benefit 

analysis, we have used a VSL of 

$5,000,000. Applying this VSL, the 

social benefit from 276 non-renal 

transplants would be $1,380,000,000. 

Kidney transplantation costs are offset 

by reductions in other medical costs 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6129

over time, primarily dialysis costs. 

Since private payers generally base their 

payments on Medicare payment rates, 

we used data on Medicare payments to 

estimate the total cost to the economy of 

the additional non-renal transplants that 

would be performed. Below, based on 

2000 payment data, are 1-year estimated 

costs to the Medicare program resulting 

from a 3 percent increase in non-renal 

organ transplants. Costs for intestinal 

transplants were not available as 

Medicare did not begin paying for 

intestinal transplants until April 2001. 

However, the number was small—only 

36 intestine transplants were performed 

in the United States in 1999. In 

addition, the chart does not include 

heart-lung, kidney-pancreas, and other 

multi-organ transplants, since complete 

data are not available for these 

transplants. In 1999, there were 48 

heart-lung, 928 kidney-pancreas, and 

120 other multi-organ transplants in the 

United States, for a total, with intestinal 

transplants, of 1,132 transplants. 

Therefore, the figures below 

underestimate the economic impact of a 

3 percent increase in the number of 

transplants by approximately 14 percent 

(1,132 is approximately 14 percent of 

the 15,670 heart, liver, lung, pancreas, 

and kidney transplants performed in 

1999).

ESTIMATED ONE-YEAR COSTS OF NON-RENAL TRANSPLANTS

Organ type 3 percent increase 

Cost (inpatient 

hospital & physician) 

Heart ............................................................................................................................................................ 66 $9,277,620 

Liver ............................................................................................................................................................. 137 11,227,835 

Lung ............................................................................................................................................................. 28 2,012,976 

Pancreas ...................................................................................................................................................... 13 357,565 

Total ...................................................................................................................................................... 244 22,875,996 

In order to estimate the costs of 

providing post-transplant care, we 

turned to the Milliman and Robertson 5-

year cost estimates that were used by us 

in the regulation for Medicare and 

Medicaid hospitals, Identification of 

Potential Organ, Tissue, and Eye 

Donors. They are as follows: heart, 

$317,000; liver, $394,000; lung, 

$312,000; and pancreas, $149,000. 

However, note that in recent years, 

inpatient hospital stays for heart 

transplant patients have increased 

considerably (with a resultant rise in 

costs), whereas inpatient stays for liver 

transplant patients have decreased 

considerably. Nevertheless, as Milliman 

and Robertson estimates are the only 

transplant data available on posttransplant costs, we used their 

estimates. 

Based on their estimates, the 5-year 

costs would be as shown on the 

following chart.

Organ type 5–year cost 

Heart ..................................... $20,922,000 

Liver ...................................... 53,978,000 

Lung ...................................... 8,736,000 

Pancreas ............................... 1,937,000 

Total ............................... 85,573,000 

Formal Uncertainty Analysis 

As discussed elsewhere in this 

preamble, our best estimate of the 

impact of this proposed rule is a benefit 

of more than $1 billion each year, based 

on the number of lives we expect would 

be saved by an increase in organ 

donation and transplantation due to 

increased OPO performance. We have 

not prepared a formal uncertainty 

analysis for this proposed rule; 

however, we will prepare a formal 

uncertainty analysis for the final rule. 

Possible sources of uncertainty are the 

actual percentage improvement in organ 

donation expected by this rule and 

alternatives; the number of expected 

total donations, which varies somewhat 

year to year; the cost of competitive 

bids; the expected number of OPOs decertified, and the number of OPOs 

eligible to compete based on their 

performance measures. We request 

comments on other potential sources of 

uncertainty. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget.

List of Subjects 

42 CFR Part 413 

Health facilities, Kidney diseases, 

Medicare, Puerto Rico, Reporting and 

recordkeeping requirements. 

42 CFR Part 441 

Family planning, Grant programshealth, Infants and children, Medicaid, 

Penalties, Reporting and recordkeeping 

requirements. 

42 CFR Part 486 

Health professionals, Medicare, Organ 

procurement, X-rays. 

42 CFR Part 498 

Administrative practice and 

procedure, Health facilities, Health 

professions, Medicare, Reporting and 

recordkeeping requirements.

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV as set forth below:

PART 413—PRINCIPLES OF 

REASONABLE COST 

REIMBURSEMENT; PAYMENT FOR 

END-STAGE RENAL DISEASE 

SERVICES; PROSPECTIVELY 

DETERMINED PAYMENT RATES FOR 

SKILLED NURSING FACILITIES 

1. The authority citation for part 413 

is revised to read as follows:

Authority: Secs. 1102, 1138(b), 1812(d), 

1814(b), 1815, 1833(a), (i), and (n), 1871, 

1881, 1883, and 1886 of the Social Security 

Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 

1395g, 1395l(a), (i), and (n), 1395hh, 1395rr, 

1395tt, 1395ww, and 1395(x)(v)).

§ 413.200 [Amended] 

2. Section 413.200(f) is amended by 

removing the phrase ‘‘part 485, subpart 

D’’ and by adding ‘‘part 486, subpart D’’

in its place.

§ 413.202 [Amended] 

3. Section 413.202 is amended by 

removing the phrase ‘‘as defined in 

§ 435.302 of this chapter’’ and by adding 

‘‘as defined in § 486.302 of this chapter’’

in its place.

PART 441—SERVICES: 

REQUIREMENTS AND LIMITS 

APPLICABLE TO SPECIFIC SERVICES 

1. The authority citation for part 441 

continues to read as follows:

Authority: Sec. 1102 of the Social Security 

Act (42 U.S.C. 1302).

6130 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

§ 441.13 [Amended] 

2. Section 441.13(c) is amended by 

removing the reference ‘‘part 485, 

subpart D’’ and adding ‘‘part 486 

subpart G’’ in its place.

PART 486—CONDITIONS FOR 

COVERAGE OF SPECIALIZED 

SERVICES FURNISHED BY 

SUPPLIERS 

1. The authority citation for part 486 

is revised to read as follows:

Authority: Secs. 1102, 1138, and 1871 of 

the Social Security Act (42 U.S.C. 1302, 

1320b–g, and 1395hh) and section 371 of the 

Public Health Service Act (42 U.S.C 273).

2. Section 486.1 is amended by 

revising paragraph (a) to read as follows:

§ 486.1 Basis and scope. 

(a) Statutory basis. This part is based 

on the following sections of the Act: 

1102 and 1138(b)—for coverage of 

organ procurement services. 

1861(p)—for coverage of outpatient 

physical therapy services furnished by 

physical therapists in independent 

practice. 

1861(s) (3), (15), and (17)—for 

coverage of portable X-ray services.

* * * * *

3. Part 486 is further amended by 

revising subpart G to read as follows:

Subpart G—Requirements for 

Certification and Designation and 

Conditions for Coverage: Organ 

Procurement Organizations 

Sec. 

486.301 Basis and scope. 

486.302 Definitions. 

Requirements for Certification and 

Designation 

486.303 Requirements for certification. 

486.304 Requirements for designation. 

486.306 OPO service area size designation 

and documentation requirements. 

486.308 Designation of one OPO for each 

service area. 

486.310 Changes in ownership or service 

area.

Re-Certification and De-Certification 

486.312 De-certification. 

486.314 Appeals. 

486.316 Re-certification and competition 

processes. 

Organ Procurement Organization 

Outcome Requirements 

486.318 Condition: Outcome measures. 

Organ Procurement Organization 

Process Performance Measures 

486.320 Condition: Participation in Organ 

Procurement and Transplantation 

Network. 

486.322 Condition: Relationships with 

hospitals, critical access hospitals, and 

tissue banks. 

486.324 Condition: Administration and 

governing body. 

486.326 Condition: Human resources. 

486.328 Condition: Reporting of data. 

486.330 Condition: Information 

management. 

486.342 Condition: Requesting consent. 

486.344 Condition: Donor evaluation and 

management, and organ placement and 

recovery. 

486.346 Condition: Organ preparation and 

transport. 

486.348 Condition: Quality assessment and 

performance improvement (QAPI).

Subpart G—Requirements for 

Certification and Designation and 

Conditions for Coverage: Organ 

Procurement Organizations

§ 486.301 Basis and scope. 

(a) Statutory basis. (1) Section 1138(b) 

of the Act sets forth the requirements 

that an organ procurement organization 

(OPO) must meet to have its organ 

procurement services to hospitals 

covered under Medicare and Medicaid. 

These include certification as a 

‘‘qualified’’ OPO and designation as the 

OPO for a particular service area. 

(2) Section 371(b) of the Public Health 

Service Act sets forth the requirements 

for certification and the functions that a 

qualified OPO is expected to perform. 

(3) Section 1102 of the Act authorizes 

the Secretary of Health and Human 

Services to make and publish rules and 

regulations necessary to the efficient 

administration of the functions that are 

assigned to the Secretary under the Act. 

(b) Scope. This subpart sets forth—

(1) The conditions and requirements 

that an OPO must meet; 

(2) The procedures for certification 

and designation of OPOs; and 

(3) The terms of the agreement with 

CMS and the basis for and the effect of 

termination or non-renewal of the 

agreement. 

(4) The requirements for an OPO to be 

re-certified for the performance data 

cycle from January 1, 2002 through 

December 31, 2005.

§ 486.302 Definitions. 

As used in this subpart, the following 

definitions apply: 

Adverse event means an untoward, 

undesirable, and usually unanticipated 

event that causes death or serious injury 

or the risk thereof. As applied to OPOs, 

adverse events include but are not 

limited to transmission of disease from 

a donor to a recipient, avoidable loss of 

a medically suitable potential donor for 

whom consent for donation has been 

obtained, or delivery to a transplant 

center of the wrong organ or an organ 

whose blood type does not match the 

blood type of the intended recipient. 

Agreement cycle refers to the 4-year 

time period of the agreement between 

CMS and an OPO. To provide sufficient 

time for CMS to analyze outcome 

performance data and assign OPO 

service areas, the OPO agreement cycle 

generally begins on August 1 of the year 

following the end of the re-certification 

cycle and lasts for 4 years.

Certification means a determination 

by the Secretary that an OPO meets the 

requirements at § 486.303 and is eligible 

for designation if it meets the additional 

requirements for designation. 

Death record review is an assessment 

of the medical chart of a deceased 

patient to evaluate potential for organ 

donation. 

De-certification means a CMS 

determination that an OPO no longer 

meets one or more conditions for 

coverage, including the outcome 

measures, the process performance 

measures and other requirements, or no 

longer meets the requirements for 

certification or designation. In addition, 

if an OPO’s agreement with CMS is 

terminated or is not renewed, the OPO 

is de-certified. 

Designated requestor is an individual 

(generally employed by a hospital), who 

is trained to handle or participate in the 

donation consent process. The 

designated requestor may request 

consent for donation from the family of 

a potential donor or from the 

individual(s) responsible for making the 

donation decision in circumstances 

permitted under State law, provide 

information about donation to the 

family or decision-maker(s), or provide 

support to or collaborate with the OPO 

in the donation consent process. 

Designation means CMS assignment 

of a geographic service area to an OPO. 

Once an OPO is certified and assigned 

a geographic service area, organ 

procurement costs of the OPO are 

eligible for Medicare and Medicaid 

payment under section 1138(b)(1)(F) of 

the Act. 

Donor means a deceased individual 

from whom at least one vascularized 

organ (heart, liver, lung, kidney, 

pancreas, or intestine) is recovered for 

the purpose of transplantation. 

Donor document means any 

documented indication of an 

individual’s choice in regard to 

donation that meets the requirements of 

the governing state law. 

Entire metropolitan statistical area

means a metropolitan statistical area 

(MSA), a consolidated metropolitan 

statistical area (CMSA), or a primary 

metropolitan statistical area (PMSA) 

listed in the State and Metropolitan 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6131

Area Data Book published by the U.S. 

Bureau of the Census. CMS does not 

recognize a CMSA as a metropolitan 

area for the purposes of establishing a 

geographical area for an OPO. 

Open area means an OPO service area 

for which CMS has notified the public 

that it is accepting applications for 

designation. 

Organ means a human kidney, liver, 

heart, lung, pancreas, or intestine (or 

multivisceral organs when transplanted 

at the same time as an intestine). 

Organ donor potential means the 

number of patients whose age is 70 or 

less meeting death by neurological 

criteria, based on generally accepted 

practice parameters for determining 

brain death, who do not have any of the 

following clinical indications: 

(1) Tuberculosis. 

(2) Creutzfeldt-Jacob Disease or any 

other prion-induced disease. 

(3) Viral septicemia. 

(4) Rabies. 

(5) Reactive hepatitis B surface 

antigen. 

(6) Any retro virus infection. 

(7) Active malignant neoplasms, 

except primary central nervous system 

tumors and basal and squamous cell 

carcinomas. 

(8) Aplastic anemia. 

(9) Agranulocytosis. 

(10) Active viral and systemic fungal 

infections. 

(11) Gangrene of bowel. 

(12) Extreme prematurity.

(13) Positive serological or viral 

culture findings for HIV. 

(14) Chagas disease. 

Organ procurement organization 

(OPO) means an organization that 

performs or coordinates the 

procurement, preservation, and 

transport of organs and maintains a 

system for locating prospective 

recipients for available organs. 

Potential donor denominator is the 

basis for the OPO outcome measures. 

The potential donor denominator 

indicates the number of individuals in 

an OPO’s service area who meet the 

criteria for organ donor potential. 

Re-certification cycle means the 4-

calendar-year cycle of outcome measure 

data on which an OPO’s re-certification 

is based. The re-certification cycle 

begins on January 1 and ends (4 years 

later) on December 31. 

Service area means a geographical 

area of sufficient size to ensure 

maximum effectiveness in the 

procurement and equitable distribution 

of organs and that either includes an 

entire metropolitan statistical area or 

does not include any part of such an 

area and that meets the standards of this 

subpart. 

Transplant hospital means a hospital 

that provides organ transplants and 

other medical and surgical specialty 

services required for the care of 

transplant patients. There may be one or 

more types of organ transplant centers 

operating within the same transplant 

hospital. 

Requirements for Certification and 

Designation

§ 486.303 Requirements for certification. 

In order to be certified, an organ 

procurement organization must: 

(a) Have received a grant under 42 

U.S.C. 273(a). 

(b) Be a non-profit entity that is 

exempt from Federal income taxation 

under § 501 of the Internal Revenue 

Code of 1986. 

(c) Have accounting and other fiscal 

procedures necessary to assure the fiscal 

stability of the organization, including 

procedures to obtain payment for 

kidneys and non-renal organs provided 

to transplant hospitals. 

(d) Have an agreement with the 

Secretary to be reimbursed under title 

XVIII for the procurement of kidneys. 

(e) Have been re-certified as an OPO 

under the Medicare program from 

January 1, 2002 through December 31, 

2005. 

(f) Have procedures to obtain payment 

for non-renal organs provided to 

transplant centers. 

(g) Agree to enter into an agreement 

with any hospital or critical access 

hospital in the OPO’s service area, 

including a transplant hospital, that 

requests an agreement. 

(h) Meet or have met the conditions 

for coverage, including the outcome 

measures and the process performance 

measures and other requirements.

§ 486.304 Requirements for designation. 

(a) Designation is a condition for 

payment. Payment may be made under 

the Medicare and Medicaid programs 

for organ procurement costs attributable 

to payments made to an OPO by a 

hospital only if the OPO has been 

designated by the Secretary as an OPO. 

(b) Requirements for designation. An 

OPO must do the following: 

(1) Be certified as a qualified OPO by 

the Secretary under 42 U.S.C. 273(b) 

and § 486.303. 

(2) Enter into an agreement with CMS 

that meets the requirements set forth in 

paragraph (c) of this section. 

(3) Document that it has a defined 

service area that meets the requirements 

of § 486.306. 

(c) Agreement with CMS. In order for 

the organ procurement costs attributable 

to the OPO to be reimbursed under 

Medicare and Medicaid, an OPO must 

enter into an agreement with CMS. The 

agreement is effective upon submission 

by the OPO and acceptance by CMS but 

may be canceled by either party. If an 

OPO is de-certified under § 486.312, 

payment for organ procurement services 

attributable to that OPO will not be 

made for services furnished on or after 

the effective date of the de-certification. 

In the agreement, the OPO must agree to 

do the following: 

(1) Maintain compliance with the 

requirements of titles XVIII and XIX of 

the Act, section 1138 of the Act, section 

371(b) of the Public Health Service Act, 

and applicable regulations, including 

the conditions set forth in this subpart 

and the rules and requirements of the 

OPTN, as defined by § 486.320, and to 

report promptly to the Secretary any 

failure to do so. 

(2) Become a member of the OPTN. 

(3) File a cost report in accordance 

with § 413.24(f) of this chapter within 5 

months after the end of each fiscal year. 

(4) Permit CMS to designate an 

intermediary to determine the interim 

payment rate payable to transplant 

hospitals for services provided by the 

OPO and to make a determination of 

reasonable cost based on the cost report 

in the OPO files.

(5) Provide budget or cost projection 

information as may be required to 

establish an initial interim payment 

rate. 

(6) Pay to CMS amounts that have 

been paid by CMS to transplant 

hospitals as Medicare payment for organ 

recovery fees that are determined to be 

in excess of the reasonable cost of the 

services provided by the OPO. 

(7) Not charge an individual for items 

or services for which that individual is 

entitled to have payment made under 

the Medicare program. 

(d) Application for designation. An 

OPO that has met 4 out of 5 outcome 

performance measures at or above the 

mean for the previous re-certification 

cycle may apply for designation for the 

service area of an OPO that did not meet 

the conditions for coverage for the 

previous re-certification cycle. An OPO 

that has met 4 out of 5 outcome 

performance measures at 100 percent of 

the mean may apply for designation 

whenever a service area becomes an 

open area if the OPO’s conversion rate 

of potential donors to actual donors is 

at least 15 percentage points greater 

than the conversion rate of the OPO 

currently designated for the service area. 

(e) Designation periods—

(1) General. An OPO is normally 

designated for 4 years. A designation 

period may be shorter, for example, an 

interim designation for the service area 

of an OPO that has terminated its

6132 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

agreement with CMS. A designation 

period may be longer, for example, a 

designation may be extended if 

additional time is needed to select a 

successor OPO to an OPO that has been 

de-certified. 

(2) Re-designation. Re-certification 

and re-designation must occur not more 

frequently than every 4 years.

§ 486.306 OPO service area size 

designation and documentation 

requirements. 

(a) General documentation 

requirement. An OPO must make 

available to CMS documentation 

verifying that the OPO meets the 

requirements of paragraphs (b) through 

(d) of this section at the time of 

application and throughout the period 

of its designation. 

(b) Service area designation. The 

defined service area either includes an 

entire metropolitan statistical area or a 

New England county metropolitan 

statistical area as specified by the 

Director of the Office of Management 

and Budget or does not include any part 

of such an area. 

(c) Service area location and 

characteristics. An OPO must define 

and document a proposed service area’s 

location through the following 

information: 

(1) The names of counties (or parishes 

in Louisiana) served or, if the service 

area includes an entire State, the name 

of the State. 

(2) Geographic boundaries of the 

service area. 

(3) The number of and the names of 

all hospitals and critical access 

hospitals in the service area that have 

both a ventilator and an operating room. 

(d) It must procure organs from an 

average of at least 24 donors per 

calendar year in the 4 years before the 

year of re-designation.

§ 486.308 Designation of one OPO for each 

service area. 

(a) CMS designates only one OPO per 

service area. A service area is open for 

competition once the existing 

designation period has expired or when 

the existing designated status of the 

OPO for the service area has been 

terminated. 

(b) Unless CMS has granted a hospital 

a waiver under paragraphs (d) through 

(f) of this section, the hospital must 

enter into an agreement only with the 

OPO designated to serve the area in 

which the hospital is located.

(c) If CMS changes the OPO 

designated for an area, hospitals located 

in that area must enter into agreements 

with the newly designated OPO or 

submit a request for a waiver in 

accordance with paragraph (d) of this 

section within 30 days of notice of the 

change in designation. 

(d) A hospital may request and CMS 

may grant a waiver permitting the 

hospital to have an agreement with a 

designated 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 

CMS establishing that—

(1) The waiver is expected to increase 

organ donations; and 

(2) The waiver will ensure equitable 

treatment of patients listed 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. 

(e) In making a determination on 

waiver requests, CMS considers—

(1) Cost effectiveness; 

(2) Improvements in quality; 

(3) Changes in a hospital’s designated 

OPO due to changes in the definitions 

of metropolitan statistical areas, if 

applicable; and 

(4) The length and continuity of a 

hospital’s relationship with an OPO 

other than the hospital’s designated 

OPO. 

(f) A hospital may continue to operate 

under its existing agreement with an 

out-of-area OPO while CMS is 

processing the waiver request. If a 

waiver request is denied, a hospital 

must enter into an agreement with the 

designated OPO within 30 days of 

notification of the final determination.

§ 486.310 Changes in ownership or service 

area. 

(a) OPO requirements. (1) A 

designated OPO considering a change in 

ownership or in its service area must 

notify CMS before putting it into effect. 

This notification is required to ensure 

that the OPO, if changed, will continue 

to satisfy Medicare and Medicaid 

requirements. The merger of one OPO 

into another or the consolidation of one 

OPO with another is considered a 

change in ownership. 

(2) A designated OPO considering a 

change in its service area must obtain 

prior CMS approval. In the case of a 

service area change that results from a 

change of ownership due to merger or 

consolidation, the OPOs must resubmit 

the information required in an 

application for designation. The OPO 

must provide information specific to the 

board structure of the new organization, 

as well as operating budgets, financial 

information, and other written 

documentation CMS determines to be 

necessary for designation. 

(b) CMS requirements. (1) If CMS 

finds that the OPO has changed to such 

an extent that it no longer satisfies the 

requirements for OPO designation, CMS 

may de-certify the OPO and declare the 

OPO’s service area to be an open area. 

An OPO may appeal such a decertification as set forth in § 486.314. 

The OPO’s service area is not opened for 

competition until the conclusion of the 

appeals process. 

(2) If CMS finds that the changed OPO 

continues to satisfy the requirements for 

OPO designation, the period of 

designation of the changed OPO is the 

remaining portion of the 4 year term of 

the OPO that was reorganized. If more 

than one designated OPO is involved in 

the reorganization, the remaining 

designation term is the longest of the 

remaining periods unless CMS 

determines that a shorter period is in 

the best interest of the Medicare and 

Medicaid programs. The changed OPO 

must continue to meet the process 

performance measures and other 

requirements at § 486.20 through 

§ 486.48 throughout the remaining 

period and must meet the outcome 

measures at § 486.318 at the end of this 

remaining period.

Re-Certification and De-Certification

§ 486.312 De-certification. 

(a) De-certification due to voluntary 

termination of agreement. If an OPO 

wishes to terminate its agreement, it 

must send written notice of its intention 

to terminate its agreement and the 

proposed effective date of the 

termination to CMS. CMS may approve 

the proposed date, set a different date 

no later than 6 months after the 

proposed effective date, or set a date 

less than 6 months after the proposed 

effective date if it determines that a 

different date would not disrupt 

services to the service area or otherwise 

interfere with the effective and efficient 

administration of the Medicare and 

Medicaid programs. If CMS determines 

that a designated OPO has ceased to 

furnish organ procurement services to 

its service area, the cessation of services 

is deemed to constitute a voluntary 

termination by the OPO, effective on a 

date determined by CMS. CMS will decertify the OPO as of the effective date 

of the voluntary termination. 

(b) De-certification due to involuntary 

termination of agreement. CMS may 

terminate an agreement with an OPO if 

CMS finds that the OPO no longer meets 

the requirements for designation or 

certification or the conditions for 

coverage in this subpart or is not in 

substantial compliance with any other 

applicable Federal regulations or 

provisions of titles XI, XVIII, or XIX of 

the Act. CMS may also terminate an 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6133

agreement immediately in cases of 

urgent need, such as the discovery of 

unsound medical practices. CMS will 

de-certify the OPO as of the effective 

date of the involuntary termination. 

(c) De-certification due to nonrenewal of agreement. CMS will not 

voluntarily renew its agreement with an 

OPO if the OPO fails to meet the 

condition for coverage at § 486.318 

based on data from the most recent recertification cycle or if the OPO’s 

designation has been terminated. CMS 

will de-certify the OPO as of the ending 

date of the agreement. 

(d) Notice to OPO. Except in cases of 

urgent need, CMS gives written notice 

of de-certification to an OPO at least 90 

days before the effective date of the decertification. In cases of urgent need, 

CMS gives written notice of decertification at least three calendar days 

prior to the effective date of the decertification. The notice of decertification states the reason for decertification and the effective date. 

(e) Public notice. Once CMS approves 

the date for a voluntary termination, the 

OPO must provide prompt public notice 

of the date of de-certification and such 

other information as CMS may require 

through publication in local newspapers 

in the service area. In the case of 

involuntary termination or non-renewal 

of an agreement, CMS provides public 

notice of the date of de-certification 

through publication in local newspapers 

in the service area. No payment under 

title XVIII or title XIX of the Act will be 

made with respect to organ procurement 

costs attributable to the OPO on or after 

the date the de-certification is effective.

§ 486.314 Appeals. 

If an OPO’s de-certification is due to 

involuntary termination or non-renewal 

of its agreement with CMS, the OPO 

may appeal the de-certification on 

substantive or procedural grounds. 

(a) Appeal process. The OPO must file 

its appeal within 30 calendar days of the 

date of the notice of de-certification. In 

its appeal, the OPO may submit 

evidence to demonstrate why it should 

not be de-certified. Within 2 weeks of 

receipt of the OPO’s appeal, a CMS 

hearing officer will schedule a hearing. 

The hearing officer will issue notice of 

his or her decision to the OPO by 

certified mail within 2 weeks of the 

hearing.

(b) Reversal of de-certification. If the 

hearing officer reverses CMS’

determination to de-certify an OPO in a 

case involving the involuntary 

termination of the OPO’s agreement, 

CMS will not terminate the OPO’s 

agreement and will not de-certify the 

OPO at that time. 

(c) De-certification is upheld. If the 

de-certification determination is upheld 

by the hearing officer, Medicare and 

Medicaid payment may not be made for 

organ procurement services the OPO 

furnishes on or after the effective date 

of de-certification. There are no further 

administrative appeal rights. 

(d) Effects of de-certification. When 

an OPO agreement is terminated or is 

not renewed, CMS will accept 

applications from other OPOs to be 

designated for the open area as set forth 

in § 486.316(b). An OPO that is decertified may not apply or be designated 

for an open area. 

(e) Extension of agreement. If there is 

insufficient time prior to expiration of 

an agreement with CMS to allow for 

competition of the service area and, if 

necessary, transition of the service area 

to a successor OPO, CMS may choose to 

extend the OPO’s agreement with CMS 

for a period not to exceed an additional 

60 days.

§ 486.316 Re-certification and competition 

processes. 

CMS opens all OPO service areas for 

competition at the end of every recertification cycle. 

(a) OPO meets conditions for 

coverage. When an OPO meets the 

outcome measures in § 486.318 and has 

been found to be in compliance with the 

process performance measures and 

other requirements in §§ 486.320 

through 486.348, CMS will open the 

OPO’s service area for competition. An 

OPO may compete for the open area 

only if it met 4 out of 5 outcome 

measures at or above 100 percent of the 

mean for the preceding re-certification 

cycle and its conversion rate of potential 

donors to actual donors is at least 15 

percentage points higher than the 

conversion rate of the OPO currently 

designated for the service area. The OPO 

must compete for the entire service area. 

The incumbent OPO may compete for 

its own service area. 

(b) OPO does not meet conditions for 

coverage. If CMS notifies an OPO that it 

will be de-certified because its 

agreement will not be renewed or will 

be terminated by CMS, and the OPO 

does not appeal within the time frame 

specified in § 486.314(a) or the OPO’s 

de-certification is upheld on appeal, 

CMS will open the OPO’s service area 

for competition from other OPOs. An 

OPO may compete for the open service 

area only if it met 4 out of 5 outcome 

measures at or above the mean for the 

preceding re-certification cycle. The 

OPO must compete for the entire area. 

(c) Criteria for selection. CMS will 

designate an OPO for an open service 

area based on the competing OPOs’

degree of success in meeting the process 

performance measures during the 

preceding re-certification cycle and the 

submission of an acceptable plan to 

increase organ donation in the open 

service area. An acceptable plan to 

increase organ donation, at a 

minimum—

(1) Is based on the competing OPO’s 

experience and success in its own 

service area; 

(2) Includes an analysis of existing 

barriers, both internal and external, to 

increasing organ donation in the open 

area; and 

(3) Provides a detailed description of 

specific activities and interventions for 

increasing organ donation in the open 

service area. 

(d) No OPO applies. If no OPO applies 

to compete for the open area, CMS may 

select a single OPO to take over the 

entire open area or may adjust the 

service area boundaries of two or more 

contiguous OPOs to incorporate the 

open area. CMS will make its decision 

based on the OPOs’ success in meeting 

the process performance measures 

during the preceding re-certification 

cycle.

Organ Procurement Organization 

Outcome Requirements

§ 486.318 Condition: Outcome measures. 

(a) With the exception of OPOs 

operating exclusively in non-contiguous 

U.S. States, U.S. territories, U.S. 

possessions, or U.S. commonwealths, an 

OPO must achieve at least 75 percent of 

the national mean in 4 of the 5 

following performance categories, 

averaged over the 4 calendar years 

before the year of re-certification: 

(1) Donors, as a percentage of the 

potential donor denominator. 

(2) Number of kidneys procured, as a 

percentage of the potential donor 

denominator. 

(3) Number of kidneys transplanted, 

as a percentage of the potential donor 

denominator. 

(4) Number of extra-renal organs 

procured, as a percentage of the 

potential donor denominator. 

(5) Number of extra-renal organs 

transplanted, as a percentage of the 

potential donor denominator. 

(b) An OPO operating exclusively in 

non-contiguous U.S. States, U.S. 

territories, U.S. possessions, or U.S. 

commonwealths must meet the 

following outcome measures at 50 

percent or more of the national mean, 

averaged over the 4 calendar years 

before the year of re-certification: 

(1) Number of kidneys procured, as a 

percentage of the potential donor 

denominator. 

6134 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

(2) Number of kidneys transplanted, 

as a percentage of the potential donor 

denominator. 

Organ Procurement Organization 

Process Performance Measures

§ 486.320 Condition: Participation in 

Organ Procurement and Transplantation 

Network. 

After being designated, an OPO must 

become a member of and abide by the 

rules and requirements of the OPTN 

established and operated in accordance 

with section 372 of the Public Health 

Service Act (42 U.S.C. 274). The term 

‘‘rules and requirements of the OPTN’’

means those rules and requirements 

approved by the Secretary. No OPO is 

considered out of compliance with 

section 1138(b)(1)(D) of the Act or this 

section until the Secretary approves the 

determination that the OPO failed to 

comply with the rules and requirements 

of the OPTN. The Secretary may impose 

sanctions under section 1138 only after 

such non-compliance has been 

determined in this manner.

§ 486.322 Condition: Relationships with 

hospitals, critical access hospitals, and 

tissue banks. 

(a) Standard: Hospital agreements. An 

OPO must have a written agreement 

with 95 percent of the hospitals and 

critical access hospitals in its service 

area that have both a ventilator and an 

operating room and have not been 

granted a waiver by CMS to work with 

another OPO. The agreement must 

describe the responsibilities of both the 

OPO and hospital or critical access 

hospital in regard to the requirements 

for hospitals at § 482.45 or § 485.643 

and specify the meaning of the terms 

‘‘timely referral’’ and ‘‘imminent death.’’

(b) Standard: Designated requestor 

training for hospital staff. The OPO 

must offer designated requestor training 

on at least an annual basis for hospital 

and critical access hospital staff. 

(c) Standard: Cooperation with tissue 

banks. (1) The OPO must have 

arrangements to cooperate with tissue 

banks that have agreements with 

hospitals and critical access hospitals 

with which the OPO has agreements. 

The OPO must cooperate in the 

following activities, as may be 

appropriate, to ensure that all usable 

tissues are obtained from potential 

donors:

(i) Screening and referral of potential 

tissue donors. 

(ii) Obtaining informed consent from 

families of potential tissue donors. 

(iii) Retrieval, processing, 

preservation, storage, and distribution of 

tissues. 

(2) An OPO is not required to have an 

arrangement with a tissue bank that is 

unwilling to have an arrangement with 

the OPO.

§ 486.324 Condition: Administration and 

governing body. 

(a) While an OPO may have more than 

one board, the OPO must have an 

advisory board that has both the 

authority described in paragraph (b) of 

this section and the following 

membership: 

(1) Members who represent hospital 

administrators, voluntary health 

associations in the OPO’s service area, 

and either intensive care or emergency 

room personnel. 

(2) An individual from a tissue bank 

who represents all tissue banks that 

have agreements with hospitals with 

which the OPO has agreements (if such 

an individual is available to serve on the 

board). The individual must be from a 

tissue bank not affiliated with the OPO, 

unless the only tissue bank in the 

service area is affiliated with the OPO. 

(3) Individuals who represent the 

public residing in the OPO’s service 

area. 

(4) A physician with knowledge, 

experience, or skill in the field of 

human histocompatibility or an 

individual with a doctorate degree in a 

biological science and with knowledge, 

experience, or skills in the field of 

human histocompatibility. 

(5) A neurosurgeon or other physician 

with knowledge or skills in 

neurosciences. 

(6) A transplant surgeon representing 

each transplant hospital in the service 

area with which the OPO has 

arrangements to coordinate its activities. 

The transplant surgeon must have 

practicing privileges and perform 

transplants in the transplant hospital 

represented. 

(b) The advisory board described in 

paragraph (a) of this section has the 

authority to recommend policies for the 

following: 

(1) Procurement of organs. 

(2) Effective agreements to identify 

potential organ donors with a 

substantial majority of hospitals in its 

service area that have facilities for organ 

donation. 

(3) Systematic efforts, including 

professional education, to acquire all 

useable organs from potential donors. 

(4) Arrangements for the acquisition 

and preservation of donated organs and 

provision of quality standards for the 

acquisition of organs that are consistent 

with the standards adopted by the 

OPTN, including arranging for testing 

with respect to preventing the 

acquisition of organs that are infected 

with the etiologic agent for acquired 

immune deficiency syndrome. 

(5) Appropriate tissue typing of 

organs. 

(6) A system for allocation of organs 

among transplant patients that is 

consistent with the rules and 

requirements of the OPTN, as defined in 

§ 486.320 of this part. 

(7) Transportation of organs to 

transplant hospitals. 

(8) Coordination of activities with 

transplant hospitals in the OPO’s 

service area. 

(9) Participation in the OPTN. 

(10) Arrangements to cooperate with 

tissue banks for the retrieval, 

processing, preservation, storage, and 

distribution of tissues as may be 

appropriate to assure that all useable 

tissues are obtained from potential 

donors. 

(11) Annual evaluation of the 

effectiveness of the OPO in acquiring 

organs.

(12) Assistance to hospitals in 

establishing and implementing 

protocols for making routine inquiries 

about organ donations by potential 

donors. 

(c) The advisory board described in 

paragraph (a) of this section has no 

authority over any other activity of the 

OPO and may not serve as the OPO’s 

governing body or board of directors. 

Members of the advisory board 

described in paragraph (a) of this 

section are prohibited from serving on 

any other OPO board. 

(d) The OPO must have bylaws for 

each of its board(s) that address 

potential conflicts of interest, length of 

terms, and criteria for selecting and 

removing members. 

(e) A governing body must have full 

legal authority and responsibility for the 

management and provision of all OPO 

services and must develop and oversee 

implementation of policies and 

procedures considered necessary for the 

effective administration of the OPO, 

including fiscal operations, the OPO’s 

quality assessment and performance 

improvement (QAPI) program, and 

services furnished under contract or 

arrangement, including agreements for 

these services. The governing body must 

appoint an individual to be responsible 

for the day-to-day operation of the OPO. 

(f) The OPO must have a procedure to 

address potential conflicts of interest for 

the governing body described in 

paragraph (e) of this section.

§ 486.326 Condition: Human resources. 

All OPOs must have a sufficient 

number of qualified staff, including a 

director, a medical director, organ 

procurement coordinators, and hospital 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6135

development staff to obtain all usable 

organs from potential donors, and to 

ensure that required services are 

provided to families of potential donors, 

hospitals, tissue banks, and individuals 

and facilities that use organs for 

research. 

(a) Standard: Qualifications. (1) The 

OPO must ensure that all individuals 

who provide services and/or supervise 

services, including services furnished 

under contract or arrangement, are 

qualified to provide or supervise the 

services. 

(2) The OPO must develop and 

implement a written policy that 

addresses potential conflicts of interest 

for the OPO’s director, medical director, 

and senior management, and 

procurement coordinators. 

(3) The OPO must have credentialing 

records for physicians and other 

practitioners who routinely recover 

organs in hospitals under contract or 

arrangement with the OPO and ensure 

that all physicians and other 

practitioners who recover organs in 

hospitals with which the OPO has 

agreements are qualified and trained. 

(b) Standard: Staffing. (1) The OPO 

must provide sufficient coverage, either 

by its own staff or under contract or 

arrangement, to assure both that 

hospital referral calls are screened for 

donor potential and that potential 

donors are evaluated for medical 

suitability in a timely manner. 

(2) The OPO must have a sufficient 

number of qualified staff to provide 

information and support to potential 

organ donor families; request consent 

for donation; ensure optimal 

maintenance of the donor, efficient 

placement of organs, and adequate 

oversight of organ recovery; and 

conduct QAPI activities, such as death 

record reviews and hospital 

development. 

(3) The OPO must provide a sufficient 

number of recovery personnel, either 

from its own staff or under contract or 

arrangement, to ensure that all usable 

organs are recovered in a manner that, 

to the extent possible, preserves them 

for transplantation. 

(c) Standard: Education, training, and 

performance evaluation. The OPO must 

provide its staff with the education, 

training, and supervision necessary to 

furnish required services. Training must 

include but is not limited to 

performance expectations for staff, 

applicable organizational policies and 

procedures, and QAPI activities. OPOs 

must evaluate the performance of their 

staffs and provide training, as needed, to 

improve individual and overall staff 

performance and effectiveness. 

(d) Standard: Medical director. The 

OPO’s medical director is responsible 

for implementation of the OPO’s 

protocols for donor evaluation and 

management and organ recovery and 

placement. The medical director is 

responsible for oversight of the clinical 

management of potential donors, 

including providing assistance in 

managing a donor case when the 

surgeon on call is unavailable.

§ 486.328 Condition: Reporting of data. 

(a) The OPO must provide 

individually-identifiable, hospitalspecific organ donation and 

transplantation data to the OPTN and 

the Scientific Registry of Transplant 

Recipients (SRTR), as directed by the 

Secretary. The OPO must provide 

hospital-specific organ donation data to 

transplant hospitals, annually. The OPO 

must report individually-identifiable, 

hospital-specific organ donation and 

transplantation data and other 

information to the Department, as 

requested by the Secretary. The data 

may include, but are not limited to—

(1) Number of hospital deaths; 

(2) Results of death record reviews; 

(3) Number and timeliness of referral 

calls from hospitals; 

(4) Potential donor denominator (as 

defined in § 486.302); 

(5) Data related to non-recovery of 

organs; 

(6) Data about consents for donation; 

(7) Number of donors; 

(8) Number of organs recovered (by 

type of organ); and 

(9) Number of organs transplanted (by 

type of organ). 

(b) The potential donor denominator 

data reported to the OPTN to be used for 

OPO re-certification must include data 

for all deaths that occurred in hospitals 

and critical access hospitals in the 

OPO’s service area, unless a hospital or 

critical access hospital has been granted 

a waiver under 486.308(d) to work with 

a different OPO. Data reported by the 

OPO to the OPTN must be reported 

within 30 days after the end of the 

month in which a death occurred. If an 

OPO determines through death record 

review or other means that the potential 

donor denominator data it reported to 

the OPTN was incorrect, it must report 

the corrected data to the OPTN within 

30 days of the end of the month in 

which the mistake is identified. 

(c) For the purpose of determining the 

information to be collected under 

paragraph (a) of this section, the 

following definitions apply: 

(1) Kidneys procured. Each kidney 

recovered will be counted individually. 

En bloc kidneys recovered will count as 

two kidneys procured. 

(2) Kidneys transplanted. Each kidney 

transplanted will be counted 

individually. En bloc kidney transplants 

will be counted as two kidneys 

transplanted. 

(3) Extra-renal organs procured. Each 

organ recovered is counted individually. 

(4) Extra-renal organs transplanted. 

Each organ or part thereof transplanted 

will be counted individually. For 

example, a single liver is counted as one 

organ procured and each portion that is 

transplanted will count as a transplant. 

Further, a heart and double lung 

transplant will be counted as three 

organs transplanted. A kidney/pancreas 

transplant will count as one kidney 

transplanted and one extra-renal organ 

transplanted. 

(d) The OPO must report hospitalspecific organ donation data, including 

organ donor potential and the number of 

donors, to the public at least annually.

§ 486.330 Condition: Information 

management. 

An OPO must establish and use an 

information management system to 

maintain the required medical, social 

and identifying information for every 

donor and transplant recipient and 

develop and follow procedures to 

ensure the confidentiality and security 

of the information. 

(a) Donor information. The OPO must 

maintain a record for every donor. The 

record must include, at a minimum, 

information identifying the donor (for 

example, name, address, date of birth, 

social security number or other unique 

identifier, such as Medicare health 

insurance claim number), organs and 

(when applicable) tissues recovered, 

date of the organ recovery, donor 

management data, all test results, 

current hospital history, past medical 

and social history, the pronouncement 

of death, and consent and next-of-kin 

information. 

(b) Disposition of organs. The OPO 

must maintain records showing the 

disposition of each organ recovered for 

the purpose of transplantation, 

including information identifying 

transplant recipients. 

(c) Data retention. Donor and 

transplant recipient records must be 

maintained in a human readable and 

reproducible paper or electronic format 

for 7 years.

(d) Format of records. The OPO must 

maintain data in a format that can 

readily be transferred to a successor 

OPO and in the event of a transfer must 

provide to CMS copies of all records, 

data, and software necessary to ensure 

uninterrupted service by a successor 

OPO. Records and data subject to this 

requirement include donor and 

6136 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 

transplant recipient records and 

procedural manuals and other materials 

used in conducting OPO operations.

§ 486.342 Condition: Requesting consent. 

An OPO must encourage discretion 

and sensitivity with respect to the 

circumstances, views, and beliefs of 

potential donor families. 

(a) An OPO must have a written 

protocol to ensure that, in the absence 

of a donor document, the individual(s) 

responsible for making the donation 

decision are informed of their options to 

donate organs or tissues (when the OPO 

is making a request for tissues) or to 

decline to donate. The OPO must 

provide to the individual(s) responsible 

for making the donation decision, at a 

minimum, the following: 

(1) A list of the organs or tissues that 

may be recovered. 

(2) All possible uses for the donated 

organs or tissues. 

(3) The information that the 

individual(s) have the right to limit or 

restrict use of the organs or tissues. 

(4) A description of the screening and 

recovery processes. 

(5) Information (such as for-profit or 

non-profit status) about organizations 

that will recover, process, and distribute 

the tissue. 

(6) Information regarding access to 

and release of the donor’s medical 

records. 

(7) An explanation of the impact the 

donation process will have on burial 

arrangements and the appearance of the 

donor’s body. 

(8) Information about the procedure 

for filing a complaint. 

(9) Contact information in case the 

individual(s) making the donation 

decision have questions. 

(10) A copy of the signed consent 

form if a donation is made. 

(b) If an OPO does not request consent 

to donation because a potential donor 

consented to donation before his or her 

death in a manner that satisfied 

applicable State law requirements in the 

potential donor’s State of residence, the 

OPO must provide information about 

the donation to the family of the 

potential donor, as requested.

§ 486.344 Condition: Donor evaluation and 

management and organ placement and 

recovery. 

The OPO must have written protocols 

for donor evaluation and management 

and organ placement and recovery that 

meet current standards of practice and 

are designed to maximize organ quality 

and optimize the number of donors and 

the number of organs recovered and 

transplanted per donor. 

(a) Donor protocol management. (1) 

The medical director is responsible for 

ensuring that donor evaluation and 

management protocols are implemented 

correctly and appropriately to ensure 

that every potential donor is thoroughly 

assessed for medical suitability for 

organ donation and clinically managed 

to optimize organ viability and function. 

(2) The OPO must implement a 

system that ensures the medical director 

or other qualified physician is available 

to assist in the medical management of 

a donor when the surgeon on call is 

unavailable. 

(b) Evaluation. The OPO must do the 

following: 

(1) Verify that death has been 

pronounced according to applicable 

local, state, and federal laws pertaining 

to organ donation.

(2) Determine whether there are 

conditions that may contraindicate 

donation. 

(3) If possible, obtain the potential 

donor’s medical and social history. 

(4) Review the potential donor’s 

medical chart and perform a physical 

examination of the donor. 

(5) Obtain the donor’s vital signs and 

perform all pertinent tests. 

(c) Testing. The OPO must do the 

following: 

(1) Arrange for screening and testing 

of the donor for infectious disease 

according to current standards of 

practice, including testing for the 

human immunodeficiency virus. 

(2) Ensure that screening and testing 

of the donor (including point-of-care 

testing and blood typing) are conducted 

by a laboratory that is certified in the 

appropriate specialty or subspecialty of 

service in accordance with part 493 of 

this chapter. 

(3) Ensure that the donor’s blood is 

typed using two separate blood samples. 

(4) Document the donor’s record with 

all test results, including blood type, 

before organ recovery. 

(d) Standard: Collaboration with 

transplant programs. (1) The OPO must 

establish protocols in collaboration with 

transplant programs that define the roles 

and responsibilities of the OPO and the 

transplant program for all activities 

associated with donor evaluation, donor 

management, organ recovery, and organ 

placement. The protocol for organ 

placement must include procedures to 

ensure that the blood type of the donor 

is compared with the blood type of the 

intended recipient by two OPO staff 

members before organ recovery takes 

place and that documentation of the 

donor’s blood type accompanies the 

organ to the hospital where the 

transplant will take place. 

(2) The established protocols must be 

reviewed periodically with the 

transplant programs to incorporate best 

practices in the field and maximize 

organ donation. 

(e) Documentation of recipient 

information. Prior to recovery of an 

organ for transplantation, the OPO must 

have written documentation from the 

OPTN showing, at a minimum, the 

intended recipient’s position on the 

waiting list in relation to other suitable 

candidates and the recipient’s OPTN 

identification number and blood type. 

(f) Organ allocation. The OPO must 

have a system to allocate donated organs 

among transplant patients that is 

consistent with the rules and 

requirements of the OPTN, as defined in 

§ 486.320 of this part. 

(g) Organ placement. The OPO must 

develop and implement a protocol to 

maximize placement of organs for 

transplantation.

§ 486.346 Condition: Organ preparation 

and transport. 

(a) The OPO must arrange for testing 

of organs for infectious disease and 

tissue typing of organs according to 

current standards of practice. The OPO 

must ensure that testing and tissue 

typing of organs are conducted by a 

laboratory that is certified in the 

appropriate specialty or subspecialty of 

service in accordance with part 493 of 

this chapter. 

(b) The OPO must send complete 

documentation of donor information to 

the transplant center with the organ, 

including donor evaluation, the 

complete record of the donor’s 

management, documentation of consent, 

documentation of the pronouncement of 

death, and documentation for 

determining organ quality. Two OPO 

staff members must verify that the 

documentation that accompanies an 

organ to a transplant center is correct. 

(c) The OPO must develop and follow 

a written protocol for packaging, 

labeling, handling, and shipping organs 

in a manner that ensures their arrival 

without compromise to the quality of 

the organ or health of the recipient. The 

protocol must include procedures to 

check the accuracy and integrity of 

labels, packaging, and contents prior to 

transport, including verification by two 

OPO staff members that information 

listed on the labels is correct.

(d) All packaging in which an organ 

is transported must be marked with the 

identification number, specific contents, 

and donor’s blood type.

§ 486.348 Condition: Quality assessment 

and performance improvement (QAPI). 

The OPO must develop, implement, 

and maintain a comprehensive, datadriven QAPI program designed to 

monitor and evaluate performance of all 

Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6137

donation services, including services 

provided under contract or arrangement. 

(a) Standard: Components of a QAPI 

program. The OPO’s QAPI program 

must include objective measures to 

evaluate and demonstrate improved 

performance with regard to OPO 

activities, such as hospital development, 

designated requestor training, donor 

management, timeliness of on-site 

response to hospital referrals, consent 

practices, organ recovery and 

placement, and organ packaging and 

transport. The OPO must take actions 

that result in performance 

improvements and track performance to 

ensure that improvements are sustained. 

(b) Standard: Death record reviews.

As part of its ongoing QAPI efforts, an 

OPO must conduct death record reviews 

in every Medicare and Medicaid 

participating hospital in its service area 

that has a level I or level II trauma 

center or 150 or more beds (unless the 

hospital has a waiver to work with 

another OPO), with the exception of 

psychiatric and rehabilitation hospitals. 

When missed opportunities for donation 

are identified, the OPO must implement 

actions to improve performance. 

(c) Standard: Adverse events. (1) An 

OPO must establish a written policy to 

address adverse events that occur 

during any phase of an organ donation 

case. The policy must address, at a 

minimum, the process for identification, 

reporting, analysis, and prevention of 

adverse events. 

(2) The OPO must conduct a thorough 

analysis of any adverse event and must 

use the analysis to affect changes in the 

OPO’s policies and practices to prevent 

repeat incidents. 

(3) The OPO must—

(i) Report an adverse event to CMS 

within 10 business days of becoming 

aware of the adverse event; and 

(ii) Provide to CMS written 

documentation of the investigation and 

analysis of the adverse event within 15 

business days of becoming aware of the 

event.

PART 498—APPEALS PROCEDURES 

FOR DETERMINATIONS THAT AFFECT 

PARTICIPATION IN THE MEDICARE 

PROGRAM AND FOR 

DETERMINATIONS THAT AFFECT THE 

PARTICIPATION OF ICFs/MR AND 

CERTAIN NFs IN THE MEDICAID 

PROGRAM 

1. The authority citation for part 498 

continues to read as follows:

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh).

Subpart A—General Provisions

§ 498.2 [Amended] 

2. In § 498.2, the definition of 

‘‘Supplier’’ is amended by removing 

‘‘organ procurement organization 

(OPO),’’.

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program)

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Editorial Note: This document was 

received in the Office of the Federal Register 

on January 26, 2005.

Approved: July 29, 2004. 

Tommy G. Thompson, 

Secretary.

[FR Doc. 05–1695 Filed 1–28–05; 8:45 am] 

BILLING CODE 4120–01–P