[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Proposed Rules]
[Pages 6086-6137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1695]



[[Page 6085]]

-----------------------------------------------------------------------

Part II





Department of Health and Human Services





-----------------------------------------------------------------------



Centers for Medicare & Medicaid Services



-----------------------------------------------------------------------



42 CFR Parts 413, 441, et al.



Medicare and Medicaid Programs; Conditions for Coverage for Organ 
Procurement Organizations (OPOs); Proposed Rule

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

[[Page 6086]]


-----------------------------------------------------------------------

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

[[Page 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 best-performing 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 Sec.  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

[[Page 6088]]

clear, objective criteria for determining which OPO would be designated 
for the service area (See proposed Sec.  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 Sec.  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 performance-
related 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 Sec.  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 Sec.  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

[[Page 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 Sec.  482.45 and for critical access hospitals at 
Sec.  485.643. (Sec.  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. (Sec.  
486.326.)
     Ensure that organ recovery personnel are qualified and 
trained. (Sec.  486.326.)
     Provide education, training, and performance evaluations 
for OPO staff. (Sec.  486.326.)
     Obtain informed consent for organ and tissue donation. 
(Sec.  486.342.)
     Develop and follow protocols for donor evaluation and 
management and organ placement and recovery. (Sec.  486.344.)
     Have a medical director who is responsible for 
implementation of these protocols, as well as oversight management of 
potential donors. (Sec.  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. (Sec.  486.344 and Sec.  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. (Sec.  486.344.)
     Document recipient information, including blood type and 
position on the wait list, before organ recovery. (Sec.  486.344.)
     Develop and follow a protocol for packaging, labeling, 
handling, and shipping organs. (Sec.  486.346.)
     Establish a comprehensive, data-driven, QAPI program 
designed to monitor and evaluate performance of all donation services. 
(Sec.  486.348.)
     Perform death record reviews in hospitals with level I or 
level II trauma centers or 150 or more beds. (Sec.  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. (Sec.  486.320.)
     Designated requestor training for hospital staffs. (Sec.  
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. (Sec.  
486.324.)
     Conflict of interest policies for the governing body, OPO 
directors, medical directors, senior management, and procurement 
coordinators. (Sec.  486.324 and Sec.  486.326.)
     Credentialing records for organ recovery personnel. (Sec.  
486.326.)
     Hospital-specific organ donation and transplantation data 
reported to Secretary and public. (Sec.  486.328.)
     Information management, including donor and transplant 
recipient information, data retention, and format of records. (Sec.  
486.330.)
     A system to allocate donated organs that is consistent 
with the rules and requirements of the OPTN. (Sec.  486.344.)
     Investigation, analysis, and reporting of adverse events 
to us. (Sec.  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 Sec.  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 Sec.  486.322 and Sec.  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 Sec.  486.301)
    Section 486.301 (Basis and scope) would remain unchanged from the 
existing regulations except that we would add a reference to Sec.  1102 
of the Act, and we would add the term, ``non-renewal'' to Sec.  
486.301(b)(3) to clarify that the scope includes non-renewal of 
agreements.
Definitions (Proposed Sec.  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

[[Page 6090]]

geographic service area, organ procurement costs of the OPO are 
eligible for Medicare and Medicaid payment under Sec.  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 Sec.  486.314. The 4-year re-certification 
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 de-certification follows our determination that an OPO no longer 
meets one or more conditions for coverage (including, the outcome 
measures at Sec.  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 Sec.  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 Sec.  501 of the Internal Revenue Code of 1986. (See 
Sec.  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 Sec.  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 Sec.  
486.301(b)(4).)
    (6) Have procedures to obtain payment for non-renal organs provided 
to transplant centers. (See Sec.  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 Sec.  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 Sec.  
486.306.)
    We propose that these threshold requirements for certification must 
be met before an OPO can be designated, pursuant to our proposed Sec.  
486.304.
Requirements for Designation (Proposed Sec.  486.304)
    Provisions regarding general requirements for designation as an OPO 
currently found in Sec.  486.304 (``General requirements'') and 
requirements at Sec.  486.306 (``Qualifications for designation as an 
OPO'') would be reorganized. Some requirements found in current Sec.  
486.304 have been moved to proposed Sec.  486.303. Other requirements 
judged to be burdensome or unnecessary have been removed. For example, 
we would no longer require

[[Page 6091]]

OPOs to submit a written application for designation.
    Most requirements in the current Sec.  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 Sec.  486.324 (``Administration and governing 
body''). Requirements for agreements with hospitals, critical access 
hospitals, and tissue banks can be found in proposed Sec.  486.322 
(Relationships with hospitals, critical access hospitals, and tissue 
banks). Requirements for testing of donors and organs can be found in 
both proposed Sec.  486.344 (Donor evaluation and management and organ 
placement and recovery) and proposed Sec.  486.346 (Organ preparation 
and transport). Requirements for data reporting have been moved to 
proposed Sec.  486.328 (Reporting of data), and requirements for 
protecting privacy of data can be found in proposed Sec.  486.330 
(Information management). Finally, requirements for professional 
education can be found in Sec.  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 Sec.  413.24(f).
OPO Service Area Size Designation and Documentation Requirements 
(Proposed Sec.  486.306)
    The requirements contained in this section would be re-designated 
from the current Sec.  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 Sec.  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 re-certified 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 Sec.  
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 Sec.  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 Sec.  486.308)
    Requirements for the designation of one OPO for each service area 
would be moved from Sec.  486.316 to proposed Sec.  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 Sec.  
486.316 (``Re-certification and competition processes''). (See 
discussion of proposed Sec.  486.316 in this preamble for a discussion 
of the proposed criteria.)
Changes in Ownership or Service Area (Proposed Sec.  486.310)
    The requirements for an OPO changing ownership or changing its 
service area found in Sec.  486.318 would be moved to proposed Sec.  
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 Sec.  486.312)
[If you choose to comment on this section, please include the caption 
``De-certification'' at the beginning of your comments.]
    Many of the requirements contained in Sec.  486.325 (``Termination 
of agreement with CMS'') would be moved to proposed Sec.  486.312, but 
the title of the section would be changed to ``De-certification,'' 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 de-certify the OPO.
    The paragraph titled ``Voluntary termination'' would remain 
substantially unchanged, but the paragraph would be renamed ``De-
certification 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

[[Page 6092]]

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 de-certify 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 Sec.  
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 de-certify 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 Sec.  486.314.
    In proposed Sec.  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 de-certification 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 de-certification 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 non-renewal 
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 de-certified OPO. Thus the current language 
regarding reinstatement would no longer be needed.
Appeals (Proposed Sec.  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 de-certified the OPO as of August 1 of the year 
following the end of the re-certification 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 
de-certification 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

[[Page 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 Sec.  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 Sec.  
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 Medicare-approved 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 de-
certification 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 Sec.  486.316)
    [If you choose to comment on this section, please include the 
caption ``Re-certification 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 Sec.  
486.310 and Sec.  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

[[Page 6094]]

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                        Criteria OPOs must
   Incumbent OPO  decertified?       permitted to      Can service area     meet to compete    Criteria CMS uses
                                       compete?           be divided?        for open area       to choose OPO
----------------------------------------------------------------------------------------------------------------
Yes.............................  No................  Yes, at discretion  4 out of 5 outcome  Acceptable plan to
                                                       of CMS.             performance         increase organ
                                                                           measures at or      donation in open
                                                                           above the mean.     area.
No..............................  Yes...............  No................  4 out of 5 outcome  Acceptable plan to
                                                                           performance         increase organ
                                                                           measures at or      donation in open
                                                                           above the mean.     area.
                                                                           Conversion rate
                                                                           (actual donors as
                                                                           a percentage of
                                                                           potential donors)
                                                                           at least 15
                                                                           percentage points
                                                                           higher than
                                                                           incumbent's
                                                                           conversion rate.
----------------------------------------------------------------------------------------------------------------

Competition When OPO Has Been De-Certified
    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 Sec.  486.314(a) 
or the OPO appeals but the de-certification is upheld (see Sec.  
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 re-certification 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 de-certified 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 
de-certified 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 Sec.  486.318 for 
the previous re-certification cycle and was found to be in compliance 
with the process performance measures and other requirements at 
Sec. Sec.  486.320

[[Page 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 re-certification 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 re-certification 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 
re-certification 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 re-certify 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 Sec.  486.318 or 
the process performance measures and other requirements at Sec. Sec.  
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 re-certification 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

[[Page 6096]]

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 Sec.  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 
case-mix 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

[[Page 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 CMS-
contracted 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

[[Page 6098]]

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 above-average 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 re-certification 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 non-contiguous 
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 re-certified 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 population-
based 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 de-certification 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 two-tier method would not prevent re-certification 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 re-certification 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

[[Page 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 re-certification 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 
Sec. Sec.  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 co-morbid 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

[[Page 6100]]

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 
population-based 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 hospital-specific 
organ donation data annually (see proposed Sec.  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 re-certification 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 Sec.  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 Sec.  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 Sec.  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

[[Page 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 non-contiguous 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 re-certification: (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 non-contiguous areas would be required to meet measures 
only for kidneys procured and kidneys transplanted because there are 
few extra-renal transplant programs located in non-contiguous areas and 
because the permissible cold ischemic time for extra-renal organs is 
shorter than that for kidneys, making shipment of extra-renal 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 de-certification 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 non-
contiguous 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 Sec.  486.320)
    Current OPO regulations at Sec.  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 Sec.  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. In-house 
coordinators from LifeGift Organ Donation Center in Houston meet 
regularly with hospital medical staff to

[[Page 6102]]

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 Sec.  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 Sec.  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 
Sec. Sec.  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 Sec. Sec.  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 Sec.  
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

[[Page 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 Sec.  482.45 and critical access hospital CoP at 
Sec.  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 (Sec.  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 Sec.  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 Sec.  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

[[Page 6104]]

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 cross-reference 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 Sec.  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

[[Page 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 day-to-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 Sec.  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 Sec.  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 Sec.  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 conflict-of-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.

[[Page 6106]]

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

[[Page 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 high-performing 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, sub-optimal 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

[[Page 6108]]

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 Sec.  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 (Sec.  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 individually-identifiable, 
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, hospital-
specific 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 Sec.  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).
    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

[[Page 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 hospital-specific 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 
hospital-specific 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 good-performing 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

[[Page 6110]]

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 Sec.  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 Sec.  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 Sec.  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 
Sec.  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 
Sec.  486.344(a) and (b). Consent and next-of-kin information would be 
used to assess compliance with Sec.  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 Sec.  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

[[Page 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 
decision-makers 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 Sec.  482.45(a)(4), and in critical access hospital 
regulations at Sec.  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 for-
profit 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 Sec.  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

[[Page 6112]]

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-of-care 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-
of-care 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

[[Page 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 Sec.  
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 Sec.  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) Sec.  
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

[[Page 6114]]

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-to-day operations of 
the OPO. OPOs with these programs utilize them for data-based 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

[[Page 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, data-driven 
program to monitor and evaluate all donation services.
    The hospital CoP at Sec.  482.45(a)(5) and critical access hospital 
CoP at Sec.  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

[[Page 6116]]

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 (Sec.  413.200, (Sec.  413.202, Sec.  
441.13, and Sec.  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 Sec.  498.1 
to remove OPOs from the definition of ``supplier'' under part 498. 
Since we propose a process for OPOs to appeal a de-certification 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 Sec.  441.13(c), and in Sec.  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 re-designation occurred, these two 
references were not amended to reflect the change.
    In addition, Sec.  413.202 refers to OPOs ``as defined in Sec.  
435.302 or this chapter''. This is an error. We propose correcting this 
reference to read ``as defined in Sec.  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 Sec.  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 (Sec.  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 Sec.  486.306.
    An OPO would have to enter into an agreement with CMS. In the 
agreement,

[[Page 6117]]

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 Sec.  486.20, and to report promptly to the 
Secretary any failure to do so.
    (2) File a cost report in accordance with Sec.  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 (Sec.  
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 (Sec.  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 (Sec.  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 (Sec.  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 (Sec.  486.314)

    Under this section, 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. 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.
    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 (Sec.  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.

[[Page 6118]]

    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 re-certification 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 
(Sec.  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 Sec.  482.45. The agreement would have to 
address the requirement in Sec.  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 (Sec.  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 (Sec.  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 (Sec.  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 re-certification 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.

[[Page 6119]]

    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 (Sec.  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 (Sec.  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 non-profit 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 (Sec.  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 (Sec.  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, data-driven 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.

[[Page 6120]]

    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: [email protected]; 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, non-profit 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.

[[Page 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 de-certified 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 
re-certified, 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

[[Page 6122]]

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 de-certified 
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 re-certification 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,

[[Page 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 better-performing 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 re-certification 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 de-certified 
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 re-certification.

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:

[[Page 6124]]

     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 Sec.  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 full-time 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 part-time 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

[[Page 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

[[Page 6126]]

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 
hospital-specific 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 Sec.  482.45 and Sec.  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

[[Page 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 low-cost 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

[[Page 6128]]

(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 Sec.  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

[[Page 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
------------------------------------------------------------------------
                                                        Cost (inpatient
            Organ type                  3 percent          hospital &
                                         increase          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 post-transplant 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 de-certified, 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 programs-health, 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)).


Sec.  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.


Sec.  413.202  [Amended]

    3. Section 413.202 is amended by removing the phrase ``as defined 
in Sec.  435.302 of this chapter'' and by adding ``as defined in Sec.  
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).

[[Page 6130]]

Sec.  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:


Sec.  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


Sec.  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.


Sec.  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 Sec.  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

[[Page 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


Sec.  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 Sec.  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.


Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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

[[Page 6132]]

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.


Sec.  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.


Sec.  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.


Sec.  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 de-certification as 
set forth in Sec.  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 Sec.  486.20 through Sec.  486.48 throughout the 
remaining period and must meet the outcome measures at Sec.  486.318 at 
the end of this remaining period.

Re-Certification and De-Certification


Sec.  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 de-certify 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

[[Page 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 non-renewal of agreement. CMS will not 
voluntarily renew its agreement with an OPO if the OPO fails to meet 
the condition for coverage at Sec.  486.318 based on data from the most 
recent re-certification 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 de-certification. In cases of urgent need, 
CMS gives written notice of de-certification at least three calendar 
days prior to the effective date of the de-certification. The notice of 
de-certification states the reason for de-certification 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.


Sec.  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 Sec.  
486.316(b). An OPO that is de-certified 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.


Sec.  486.316  Re-certification and competition processes.

    CMS opens all OPO service areas for competition at the end of every 
re-certification cycle.
    (a) OPO meets conditions for coverage. When an OPO meets the 
outcome measures in Sec.  486.318 and has been found to be in 
compliance with the process performance measures and other requirements 
in Sec. Sec.  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 Sec.  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


Sec.  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.

[[Page 6134]]

    (2) Number of kidneys transplanted, as a percentage of the 
potential donor denominator.

Organ Procurement Organization Process Performance Measures


Sec.  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.


Sec.  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 Sec.  482.45 or Sec.  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.


Sec.  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 Sec.  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.


Sec.  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

[[Page 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.


Sec.  486.328  Condition: Reporting of data.

    (a) The OPO must provide individually-identifiable, hospital-
specific 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 Sec.  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 hospital-specific organ donation data, 
including organ donor potential and the number of donors, to the public 
at least annually.


Sec.  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

[[Page 6136]]

transplant recipient records and procedural manuals and other materials 
used in conducting OPO operations.


Sec.  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.


Sec.  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 Sec.  486.320 of this 
part.
    (g) Organ placement. The OPO must develop and implement a protocol 
to maximize placement of organs for transplantation.


Sec.  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.


Sec.  486.348  Condition: Quality assessment and performance 
improvement (QAPI).

    The OPO must develop, implement, and maintain a comprehensive, 
data-driven QAPI program designed to monitor and evaluate performance 
of all

[[Page 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


Sec.  498.2  [Amended]

    2. In Sec.  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