[Federal Register: February 4, 2005 (Volume 70, Number 23)]
[Proposed Rules]
[Page 6085-6137]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe05-26]
[[Page 6085]]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 413, 441, et al.
Medicare and Medicaid Programs; Conditions for Coverage for Organ
Procurement Organizations (OPOs); Proposed Rule
[[Page 6086]]
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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.
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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
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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: CMartin@omb.eop.gov; or faxed to OMB at (202) 395-
6974.
IV. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the major comments in the preamble to that
document.
V. Regulatory Impact
We have examined the impacts of this proposed rule as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review)
and the Regulatory Flexibility Act (RFA)(September 19, 1980 Pub. L. 96-
354). Section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4) and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more annually). This proposed rule
is an economically significant rulemaking under Executive Order 12866.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, 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