Proposed Rule: Medicare: Organ Procurement Organizations New Standards For Coverage

Friday,
February 4, 2005
Part II
Department of
Health and Human
Services
Centers for Medicare & Medicaid Services
42 CFR Parts 413, 441, et al.

Medicare and Medicaid Programs;
Conditions for Coverage for Organ
Procurement Organizations (OPOs);
Proposed Rule
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6086 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules
DEPARTMENT OF HEALTH AND arrival with one of our staff members. I. Background
HUMAN SERVICES Room 445–G, Hubert H. Humphrey
A. Key Statutory Provisions
Building, 200 Independence Avenue,
Centers for Medicare & Medicaid SW., Washington, DC 20201; or 7500 The Organ Procurement Organization
Services Security Boulevard, Baltimore, MD Certification Act of 2000 (section 701 of
21244–1850. Pub. L. 106–505) and section 219 of the
42 CFR Parts 413, 441, 486 and 498 (Because access to the interior of the Conference Report accompanying the
HHH Building is not readily available to Consolidated Appropriations Act, 2001
[CMS–3064–P]
persons without Federal Government (Pub. L. 106–554) contain identical
RIN: 0938–AK81 identification, commenters are provisions that amended section
encouraged to leave their comments in 371(b)(1) of the Public Health Service
Medicare and Medicaid Programs; the CMS drop slots located in the main (PHS) Act (42 U.S.C. 273(b)(1)). The
Conditions for Coverage for Organ lobby of the building. A stamp-in clock legislation directs the Secretary to
Procurement Organizations (OPOs) is available for persons wishing to retain establish regulations that include four
AGENCY: Centers for Medicare & a proof of filing by stamping in and major requirements. These are to:
retaining an extra copy of the comments 1. Increase the re-certification cycle
Medicaid Services (CMS), HHS.
being filed.) for OPOs from 2 to at least 4 years.
ACTION: Proposed rule. 2. Establish outcome and process
Comments mailed to the addresses
SUMMARY: This proposed rule would indicated as appropriate for hand or performance measures based on
establish new conditions for coverage courier delivery may be delayed and empirical evidence, obtained through
for organ procurement organizations received after the comment period. reasonable efforts, of organ donor
(OPOs), including multiple new Submission of comments on potential and other related factors in
outcome and process performance paperwork requirements. You may each service area of qualified OPOs.
submit comments on this document’s 3. Establish multiple outcome
measures based on donor potential and
paperwork requirements by mailing measures.
other related factors in each service area 4. Establish a process for OPOs to
of qualified OPOs. We are proposing your comments to the addresses
appeal a de-certification on substantive
new standards with the goal of provided at the end of the ‘‘Collection
and procedural grounds.
improving OPO performance and of Information Requirements’’ section in The re-certification cycle was
increasing organ donation. this document. increased from 2 years to 4 years
DATES: We will consider comments if For information on viewing public
through an interim final rule with
we receive them at the appropriate comments, see the beginning of the
comment (December 28, 2001, 66 FR
address, as provided below, no later SUPPLEMENTARY INFORMATION section.
67109), ‘‘Emergency Re-certification for
than 5 p.m. on April 5, 2005. FOR FURTHER INFORMATION CONTACT: Coverage for Organ Procurement
ADDRESSES: In commenting, please refer Marcia Newton, (410) 786–5265. Diane Organizations (OPOs).’’ The interim
to file code CMS–3064–P. Because of Corning, (410) 786–8486. final rule re-certified all 59 OPOs until
staff and resource limitations, we cannot SUPPLEMENTARY INFORMATION: December 31, 2005 and extended their
accept comments by facsimile (FAX) Submitting Comments: We welcome agreements with us until July 31, 2006.
transmission. comments from the public on all issues Thus, the re-certification cycle set forth
You may submit comments in one of set forth in this rule to assist us in fully in the interim final rule satisfies the first
three ways (no duplicates please): considering issues and developing of the new criteria (that is, certification
You may submit comments in one of policies. You can assist us by not more frequently than once every 4
three ways (no duplicates, please): referencing the file code CMS–3064–P years.) Our proposed rule addresses the
1. Electronically. You may submit and the specific ‘‘issue identifier’’ that remaining three requirements.
electronic comments on specific issues precedes the section on which you Section 1138 of the Social Security
in this regulation to http:// choose to comment. Act (the Act) (42 U.S.C. 1320b–8)
www.cms.hhs.gov/regulations/ Inspection of Public Comments: All provides the statutory qualifications and
ecomments. (Attachments should be in comments received before the close of requirements that an OPO must meet in
Microsoft Word, WordPerfect, or Excel; the comment period are available for order for organ procurement costs to be
however, we prefer Microsoft Word.) viewing by the public, including any reimbursed in hospitals and critical
2. By mail. You may mail written personally identifiable or confidential access hospitals under the Medicare or
comments (one original and two copies) business information that is included in Medicaid programs. Section 1138(b) of
to the following address ONLY: Centers a comment. CMS posts all electronic the Act also specifies that an OPO must
for Medicare & Medicaid Services, comments received before the close of operate under a grant made under
Department of Health and Human the comment period on its public Web section 371(a) of the PHS Act or must
Services, Attention: CMS–3064–P, P.O. site as soon as possible after they have be certified or re-certified by the
Box 8015, Baltimore, MD 21244–8015. been received. Hard copy comments Secretary as meeting the standards to be
Please allow sufficient time for mailed received timely will be available for a qualified OPO. Under these
comments to be received before the public inspection as they are received, authorities, we previously established
close of the comment period. generally beginning approximately 3 conditions for coverage for OPOs at 42
3. By hand or courier. If you prefer, weeks after publication of a document, CFR 486.301, et seq. (May 2, 1996, 61
you may deliver (by hand or courier) at the headquarters of the Centers for FR 19722).
your written comments (one original Medicare & Medicaid Services, 7500 Section 1102 of the Act gives the
and two copies) before the close of the Security Boulevard, Baltimore, Secretary of Health and Human Services
comment period to one of the following Maryland 21244, Monday through the authority to make and publish such
addresses. If you intend to deliver your Friday of each week from 8:30 a.m. to rules and regulations as may be
comments to the Baltimore address, 4 p.m. To schedule an appointment to necessary to the efficient administration
please call telephone number (410) 786– view public comments, phone 1–800– of the functions with which he is
9994 in advance to schedule your 743–3951. charged under the Act. This section of
Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Proposed Rules 6087
the Act gives the Secretary broad E Guadagnoli, C Christiansen, C our overall goal is to improve the
authority to establish requirements for Beasley, Potential Organ-Donor Supply functioning of poor performing OPOs,
OPOs that are necessary for the efficient and Efficiency of Organ Procurement rather than simply to terminate them.
administration of the Medicare program. Organizations, Health Care Financing In April 2001, the Department of
Review, Vol. 24, No. 24, Summer 2003.) Health and Human Services (the
B. Why We Are Proposing New OPO
However, there were only 6,182 Department) launched ‘‘The Secretary’s
Regulations
deceased donors in 2002 and only Donation Initiative,’’ a multi-pronged
OPOs are government contractors that 18,244 transplants resulting from those effort to increase all types of donation—
play a crucial role in ensuring that donations. Based on these estimates, blood, marrow, tissue, and organ. In his
scarce transplantable human organs are OPOs are recovering organs from, at speech launching the Initiative, the
provided to seriously ill patients most, only a little more than half the Secretary noted, ‘‘The facts are just
suffering from end-stage organ failure. number of potential donors per year. astounding. Someone dies every 96
OPOs are responsible for identifying The study published in The New minutes because there aren’t enough
potential organ donors, informing England Journal of Medicine found that organs to go around.’’ The five initial
families about their donation options, of all potential organ donors reported in key elements of the Initiative were the
obtaining consent to donation, screening the study, only 42 percent became Workplace Partnership for Life, a new
potential donors for infectious disease, donors. Of those families who were model donor card, a national forum on
clinically managing potential organ asked to donate, only 39 percent agreed, donor registries, a national gift of life
donors to maintain viability of their and 16 percent of families were never medal, and a drivers’ education
organs, placing the maximum number of asked whether they would agree to donation curriculum. The Department
organs possible with transplant centers, donation. The study published in the promised that it would launch
arranging for recovery, testing, and Health Care Financing Review found additional elements under the Initiative
tissue typing of organs, and packaging that of all potential organ donors in the future. The Organ Donation
and transporting organs to transplant reported in the study, only 35 percent Breakthrough Collaborative is the sixth
hospitals. Clearly, OPO performance is became donors. key element of the Secretary’s Initiative.
one of the most critical elements of the Over the years, many research studies The Secretary believes promulgation of
nation’s organ transplantation system. have analyzed factors that impact the multiple outcome and process
An OPO that is effective in procuring donation rates, including health performance measures in this rule will
organs and delivering them safely to professionals’ attitudes toward improve OPO performance and, as a
transplant centers will save more lives donation, the setting in which requests result, increase organ donation and
than an ineffective OPO. Therefore, for donation are made, and medical transplantation in the United States.
under the broad authority in the statute, examiner prohibitions on donation.
the Secretary has established Recently, researchers have increasingly B. Overview of Key Proposed Provisions
performance standards for OPOs so that turned their attention to the best 1. Appeals and Competition Processes
they excel in their critical mission. practices of OPOs whose service areas
The need for organ donors is acute have high donation rates. In the congressional findings
and growing rapidly. While medical In April 2003, the Health Resources associated with section 219 of the
advances have made transplantation a and Services Administration (HRSA) Conference Report accompanying the
viable treatment option for many began an ongoing ‘‘Organ Donation Consolidated Appropriations Act, 2001
patients suffering from end-stage organ Breakthrough Collaborative’’ to bring (42 U.S.C. 219(a)(2)) Congress found
failure, the supply of organs has not best practices in organ donation to that the process for OPO re-certification
kept pace with the number of patients OPOs and hospitals, particularly to created a level of uncertainty among
who need them. Since 1996 when the hospitals identified as having the OPOs that interfered with their
current OPO regulations went into effect greatest number of potential donors. effectiveness in increasing organ
through the end of 2002, the number of More than three-quarters of the 59 OPOs donation. Therefore, Congress directed
patients waiting for organs increased by are participating in the Collaborative. By the Secretary to develop a process for
nearly 60 percent to more than 80,792, studying the practices of six of the best- OPOs to appeal a de-certification on
while the number of deceased donors performing OPOs, the Collaborative’s substantive and procedural grounds.
grew by only 14 percent. As of June 23, researchers have already identified (See section 219(c)(3) codified at 42
2003, there were 82,049 patients waiting several best practices for OPOs, as well U.S.C. 273(b)(1)(D)(ii)(iv).) Under this
for a transplant. as strategies for implementing them. authority, we are proposing a
Various studies, including those by Many of the best practices and streamlined appeals process, in which
the Harvard School of Public Health, the associated strategies are discussed an OPO facing de-certification could
Partnership for Organ Donation, and the throughout this preamble to provide appeal and receive a decision on its
Association of Organ Procurement guidance for OPOs in implementing the appeal before its service area is opened
Organizations (AOPO), have estimated requirements of the proposed rule. for competition from other OPOs. (See
that approximately 10,500 to 22,000 Our proposals would fundamentally proposed § 486.314.)
deaths occurring in the United States change the existing OPO regulations to To further reduce the level of
every year could yield suitable donor emphasize quality and continuous uncertainty identified by Congress, we
organs. (C Christiansen, S Gortmaker, J quality improvement. The changes propose making certain changes in the
William, et al: A Method for Estimating would ensure that each OPO utilizes current re-certification process.
Solid Organ Donor Potential by Organ best practices to improve its efficiency, Although we would open every OPO’s
Procurement Region, American Journal effectiveness, and quality. While the service area for competition at the end
of Public Health, Vol. 88, No. 22, requirements in the proposed rule apply of every re-certification cycle as under
November, 1998. E Sheey, S Conrad, L to all OPOs, we have specifically the current regulations, we would: (1)
Brigham, et al: Estimating the Number targeted the requirements toward OPOs Permit OPOs to compete for open areas
of Potential Organ Donors in the United that may not understand the value of only if they met certain specific
States, The New England Journal of incorporating best practices into the objective criteria; (2) allow competition
Medicine, 349:667–74, August 14, 2003. structure of their organizations. Thus, only for entire service areas; and (3) use
clear, objective criteria for determining donor potential and other related factors Our experience with top-performing
which OPO would be designated for the in each service area of qualified organ OPOs supports the validity of the
service area (See proposed § 486.316.) procurement organizations.’’ In the literature on best practices. In 1998, we
A more extensive discussion of our congressional findings associated with developed four ‘‘OPO Coordinator’’
proposal for the appeals and section 219 of the Conference Report positions in the four CMS Regional
competition processes, as well as a accompanying the Consolidated Consortia (Midwest, West, South, and
description of other competition Appropriations Act, 2001 (Pub. L. 106– Northeast). The OPO Coordinator
processes on which we are requesting 554, 42 U.S.C. 219(a)(6)(B)), Congress positions are unique; OPOs are the only
comments, can be found in this urged us to ‘‘improve the overall Medicare providers or suppliers that
preamble under proposed ‘‘General certification process’’ by incorporating have our staff assigned to work with
Requirements.’’ process as well as outcome performance them on an ongoing basis to improve
2. Proposed Multiple Outcome measures. Congress noted that current their quality and outcomes. The
Performance Measures OPO regulations do not permit Coordinators sponsor seminars, conduct
consideration of outcome and process conferences and workshops, provide
When we published the current OPO performance measures that ‘‘would education for OPO staffs, conduct site
regulations in 1996, population was the more accurately reflect the relative visits, meet with OPO directors and
only measure readily available to assess capability and performance of each hospital development staffs, recommend
donor potential. Therefore, we organ procurement organization.’’ interventions to increase OPO efficiency
promulgated regulations that judge an Therefore, we propose to establish and quality, analyze OPO’s voluntary
OPO’s performance based on the outcome and process performance- quality improvement efforts, and act as
population in its service area (for related measures based on factors that liaisons between OPOs and hospitals
example, the number of donors per affect an OPO’s ability to provide the and between OPOs and tissue banks to
million population). Subsequently, we maximum number of healthy organs to resolve problems and promote
began to investigate alternative methods transplant centers. The purpose of these cooperation. (We would note that for
for assessing donor potential in order to measures is to improve OPO ease of use, the term ‘‘tissue bank’’
develop new outcome measures based performance and increase organ when used in this preamble and in the
on the organ donation potential in each donation by ensuring that OPOs attain proposed regulations text refers to all
OPO’s service area. This preamble the highest possible level of types of tissue banks, including those
contains a discussion of our analysis of effectiveness and quality. The process that recover only corneas and eyes, and
these alternative methods, as well as an performance measures we propose the word ‘‘tissues’’ refers to all types of
explanation of the method we propose— would require OPOs to develop tissues, including corneas and eyes.)
using potential donor data reported by performance protocols, monitor their The proposed process performance
OPOs to the Organ Procurement and own performance continuously, and measures are based heavily on the
Transplantation Network (OPTN) based make changes to improve the quality of Coordinators’ extensive experience with
on information from hospital referral their organizations. all 59 OPOs. The Coordinators’
calls to OPOs. A discussion of the The proposed new process experience with and knowledge about
proposed multiple outcome measures performance measures are based on OPOs provide much of the empirical
can be found in this preamble under empirical evidence of organ donor evidence that has enabled us to develop
‘‘OPO Outcome Performance Measures.’’ potential and other related factors in proposed process performance measures
The proposed regulatory text can be each OPO service area derived from targeted specifically toward increasing
found at § 486.318. three bodies of knowledge: (1) Research OPO performance and quality.
The proposed outcome measures into best practices in organ donation, (2) As stated earlier, some of the
would address two requirements of the information about methods of proposed requirements are based on
Organ Procurement Organization maximizing organ donation based on other factors such as accepted standards
Certification Act of 2000 and section our work with OPOs, and (3) accepted of practice for all health care
219 of the Consolidated Appropriations standards of practice and quality organizations. For example, proposed
Act, 2001. The first requirement calls for improvement strategies used by the § 486.344 would require OPOs to use
promulgation of larger health care community. accepted standards of practice for
‘‘outcome* * *performance measures A review of the literature on best testing donors to prevent transmission
that are based on empirical evidence practices in organ donation provides of the human immunodeficiency virus
obtained through reasonable efforts of empirical evidence that certain (HIV) and other infectious diseases.
organ donor potential and other related characteristics are common to Proposed § 486.348 is based on quality
factors in each service area of qualified successful OPOs. These characteristics assessment and performance
organ procurement organizations.’’ The include experienced leadership; improvement (QAPI) programs that have
second requirement calls for the use of efficient mechanisms for tracking been embraced by the health care
‘‘multiple outcome measures as part of activity; excellent communication with community and that have been shown
the certification process.’’ transplant hospitals; timely, on-site to increase quality and outcomes of
response to donor referrals; adequate care.
3. Proposed Multiple Process experienced staff; data-driven decision Therefore, the process performance
Performance Measures making; in-hospital coordinators; and measures we propose would satisfy the
In addition to proposing multiple targeted hospital development second requirement in the Organ
outcome measures, the Organ programs. We have incorporated Procurement Organization Certification
Procurement Organization Certification findings from the literature into the Act of 2000 and section 219 of the
Act of 2000 and section 219 of the proposed process performance Consolidated Appropriations Act, 2001
Consolidated Appropriations Act, 2001 measures. Discussions and citations of for the Secretary to propose process
require the Secretary to propose individual studies can be found in this performance measures ‘‘based on
‘‘process performance measures that are preamble in ‘‘Organ Procurement empirical evidence, obtained through
based on empirical evidence obtained Organization Process Performance reasonable efforts, of organ donor
through reasonable efforts of organ Measures.’’ potential and other related factors in
each OPO’s service area.’’ These include necessary for the efficient OPO’s service area, such as the OPO’s
the following proposed requirements for administration of the Medicare program. relationship with its hospitals, would
OPOs: These requirements generally are related determine whether hospitals would
• Have agreements with hospitals and to (1) administrative matters (because request, and OPOs would need to
critical access hospitals that address efficient administration by Medicare provide, designated requestor training).
responsibilities in regard to the contractors such as OPOs supports This proposed requirement also is
requirements for hospitals at § 482.45 efficient administration of the Medicare necessary to the effective and efficient
and for critical access hospitals at program); (2) OPOs’ relationships with administration of the Medicare and
§ 485.643. (§ 486.322.) Medicare donor and transplant Medicaid programs because under 42
• Maintain sufficient qualified staff hospitals; and (3) data collection, CFR § 482.45, hospitals must ensure that
(either from the OPO or under contract management, and reporting (because individuals who discuss donation with
or arrangement) to accomplish a number OPO data are needed by other Medicare families of potential organ donors are
of different objectives, including entities, by other agencies within the trained in a course offered or approved
screening referral calls for donor Department, and by us for the by the OPO.
potential, assessment of potential certification of OPOs.) These proposed Finally, section 1138(b)(1)(A) of the
donors for medical suitability, requirements include: Act requires an OPO to be a ‘‘qualified’’
requesting consent, maintaining donors, • Participation in the Organ OPO as described in section 371(b) of
placing organs, overseeing organ Procurement and Transplantation the PHS Act. A number of the
recovery, performing death record Network. (§ 486.320.) requirements we propose (for example,
reviews, and conducting QAPI • Designated requestor training for arrangements to cooperate with tissue
activities. (§ 486.326.) hospital staffs. (§ 486.322.) banks and membership composition and
• Ensure that organ recovery • Legal authority of a governing body authority of OPO boards) are based on
personnel are qualified and trained. for management and provision of OPO requirements for qualified OPOs under
(§ 486.326.) services and development and the PHS Act. (See § 486.322 and
• Provide education, training, and implementation of policies and § 486.324.) Proposed requirements that
performance evaluations for OPO staff. procedures for administration of the relate to the PHS Act are noted in the
(§ 486.326.) OPO, the OPO’s QAPI program, and broader discussion in this preamble
• Obtain informed consent for organ services furnished under contract or under ‘‘Proposed Process Performance
and tissue donation. (§ 486.342.) arrangement. (§ 486.324.) Measures and Other Requirements.’’
• Develop and follow protocols for • Conflict of interest policies for the
donor evaluation and management and governing body, OPO directors, medical II. Provisions of the Proposed
organ placement and recovery. directors, senior management, and Regulations
(§ 486.344.) procurement coordinators. (§ 486.324 For the reasons discussed above, we
• Have a medical director who is and § 486.326.) propose to reorganize and revise 42 CFR
responsible for implementation of these • Credentialing records for organ part 486, subpart G. Following is a
protocols, as well as oversight recovery personnel. (§ 486.326.) discussion of the specific requirements
management of potential donors. • Hospital-specific organ donation contained in the proposed conditions.
(§ 486.326.) and transplantation data reported to
• Arrange for screening and testing of Secretary and public. (§ 486.328.) Proposed General Requirements
the donor for infectious disease and • Information management, including
Basis and Scope (Proposed § 486.301)
testing and tissue typing of organs by a donor and transplant recipient
laboratory certified under the Clinical information, data retention, and format Section 486.301 (Basis and scope)
Laboratory Improvement Amendments of records. (§ 486.330.) would remain unchanged from the
(CLIA) of 1998. (§ 486.344 and • A system to allocate donated organs existing regulations except that we
§ 486.346.) that is consistent with the rules and would add a reference to § 1102 of the
• Collaborate with transplant requirements of the OPTN. (§ 486.344.) Act, and we would add the term, ‘‘non-
programs and have protocols defining • Investigation, analysis, and renewal’’ to § 486.301(b)(3) to clarify
OPO and transplant hospital roles and reporting of adverse events to us. that the scope includes non-renewal of
responsibilities for donor evaluation, (§ 486.348.) agreements.
donor management, organ recovery, and Some of the proposed process
performance measurements have a dual Definitions (Proposed § 486.302)
organ placement. (§ 486.344.)
• Document recipient information, role in that they both satisfy the To reflect organizational changes in
including blood type and position on requirements of the Organ Procurement the regulations text, to remove obsolete
the wait list, before organ recovery. Organization Certification Act of 2000 material, and to provide further clarity
(§ 486.344.) and section 219 of the Consolidated to the regulations, we propose several
• Develop and follow a protocol for Appropriations Act, 2001 and are based amendments and additions to the
packaging, labeling, handling, and on the Secretary’s authority under definitions.
shipping organs. (§ 486.346.) section 1102 of the Act. For example, We propose amending the definition
• Establish a comprehensive, data- the requirement for OPOs to provide for ‘‘certification’’ to mean a Secretarial
driven, QAPI program designed to designated requestor training for determination that an OPO meets (or
monitor and evaluate performance of all hospitals can be linked to the Organ has met) the requirements at 42 CFR
donation services. (§ 486.348.) Procurement Organization Certification 486.303 and is eligible for designation if
• Perform death record reviews in Act of 2000 and section 219 of the it meets the additional requirements for
hospitals with level I or level II trauma Consolidated Appropriations Act, 2001 designation.
centers or 150 or more beds. (§ 486.348.) because the requirement is based on We propose amending the definition
In addition, we propose a number of empirical evidence that shows of ‘‘designation’’ to clarify that
other requirements based on the improved consent rates when the OPO designation is the process of assigning
Secretary’s authority under section 1102 and hospital collaborate in requesting geographic service areas to OPOs. Once
of the Act to establish requirements consent. (Note that factors in each an OPO is certified and assigned a
geographic service area, organ according to § 486.314. The 4-year re- specify the requirements an OPO must
procurement costs of the OPO are certification cycle is based on the meet to be certified.
eligible for Medicare and Medicaid calendar year. Following are the proposed
payment under § 1138(b)(1)(F) of the We have included a proposed requirements. After each proposed
Act. definition for ‘‘death record review’’ requirement, we have listed the location
We propose amending the definition because we would require OPOs to of the requirement in the statute or in
of ‘‘entire metropolitan statistical area’’ perform death record reviews as part of current regulations. To be certified, an
to state that we do not recognize their QAPI programs. OPO must:
consolidated metropolitan statistical We have included a definition for (1) Have received a grant under 42
areas (CMSAs) when making service ‘‘de-certification’’ to explain that de- U.S.C. 273(a).
area determinations. certification follows our determination (2) Be a non-profit entity that is
We propose amending the definition that an OPO no longer meets one or exempt from Federal income taxation
of ‘‘organ’’ to clarify that the definition more conditions for coverage (including, under § 501 of the Internal Revenue
includes multivisceral organs only the outcome measures at § 486.318 and Code of 1986. (See § 486.306(a).)
when they are transplanted with an the process performance measures and (3) Have accounting and other fiscal
intestine. other requirements) or no longer meets procedures necessary to assure the fiscal
We propose eliminating ‘‘potential stability of the organization, including
the requirements for certification or
donor’’ and replacing it with ‘‘organ procedures to obtain payment for
designation. If an OPO’s agreement with
donor potential.’’ The definition of kidneys and non-renal organs provided
us is terminated or is not renewed, the
‘‘potential donor’’ in the current to transplant hospitals. (See
OPO is de-certified.
regulations refers to causes and § 486.306(b).)
conditions of death that are ‘‘generally We propose adding a definition for
(4) Have an agreement with the
acceptable’’ for donation of at least one ‘‘designated requestor’’ to explain the
Secretary to be reimbursed under title
solid organ.’’ In our definition for role of designated requestors in the
XVIII for the procurement of kidneys.
‘‘organ donor potential,’’ we would donation process. We propose a
(See section 371(b)(1)(C) of the PHS
include specific parameters for the definition for ‘‘donor’’ to ensure that
Act.)
cause and conditions of death that OPOs’’ reporting of donor data is (5) Have been re-certified as an OPO
indicate medical suitability for organ standardized. (The definition of under the Medicare program from
donation. These parameters are ‘‘donor’’ is not intended to limit January 1, 2002 through December 31,
discussed in this preamble under acceptable donors.) 2005. (See § 486.301(b)(4).)
‘‘Proposed OPO Outcome Measures,’’ We are proposing a definition for (6) Have procedures to obtain
section C3. We are particularly ‘‘donor document’’ because we would payment for non-renal organs provided
interested in public comments on this require OPOs to ensure that, in the to transplant centers. (See
proposed definition. absence of a donor document, the § 273(b)(1)(E).)
We propose replacing ‘‘transplant individual or individuals with (7) Agree to enter into an agreement
center’’ with ‘‘transplant hospital’’ and responsibility to make the donation with any hospital in the OPO’s service
have standardized the use of ‘‘transplant decision are informed of their option to area, including a transplant hospital,
hospital’’ throughout this proposed donate organs or tissues or to decline to that requests an agreement. (See
regulation. A transplant hospital means donate. 486.304(b)(8).)
a hospital that furnishes organ We propose adding ‘‘potential donor (8) Meet or have met the conditions
transplants and other medical and denominator’’ to the definitions because for coverage, including the outcome
surgical specialty services required for we would use this term for the potential measures and the process performance
the care of transplant patients. There donor data OPOs would report to the measures and other requirements. (See
may be one or more types of organ OPTN. Those data would be used as the § 486.314. This section states that an
transplant centers operating within the basis for the multiple outcome OPO’s agreement with CMS may be
same transplant hospital. measures. terminated if the OPO does not meet the
Additionally, we propose adding These definitions, as we propose to two conditions for coverage in the
definitions for ‘‘adverse event,’’ add or revise them, are contained in the current regulations, as well as the
‘‘agreement cycle,’’ ‘‘death record regulatory text section at the end of this requirements for qualifications for
review,’’ ‘‘de-certification,’’ ‘‘designated document. designation found in § 486.306.)
requestor,’’ ‘‘donor,’’ ‘‘donor Requirements for Certification and We propose that these threshold
document,’’ ‘‘potential donor Designation requirements for certification must be
denominator,’’ and ‘‘re-certification met before an OPO can be designated,
cycle.’’ [If you choose to comment on this pursuant to our proposed § 486.304.
We propose a definition for ‘‘adverse section, please include the caption
event’’ because we propose requiring an ‘‘Certification and Designation Requirements for Designation (Proposed
OPO to report those events to us so that Requirements’’ at the beginning of your § 486.304)
we can monitor the OPO’s response to comments.] Provisions regarding general
the adverse event. An adverse event requirements for designation as an OPO
Requirements for Certification currently found in § 486.304 (‘‘General
would mean an untoward, undesirable,
(Proposed § 486.303) requirements’’) and requirements at
and usually unanticipated event that
causes death or serious injury or the risk The current regulations do not make § 486.306 (‘‘Qualifications for
thereof. a clear distinction between the designation as an OPO’’) would be
We propose definitions for requirements necessary for certification reorganized. Some requirements found
‘‘agreement cycle’’ and ‘‘re-certification and the requirements necessary for in current § 486.304 have been moved to
cycle’’ to clarify the difference between designation, nor do they specify that an proposed § 486.303. Other requirements
the two. The 4-year CMS/OPO OPO must be certified before it is judged to be burdensome or
agreement cycle runs from August 1 designated for a service area. Therefore, unnecessary have been removed. For
through July 31, unless it is extended we propose adding a new section to example, we would no longer require
OPOs to submit a written application for re-certification cycle has been increased years to conform the designation period
designation. from 2 years to 4 years. to the re-certification cycle.
Most requirements in the current However, we would no longer permit Designation of One OPO for Each
§ 486.306 would be incorporated into exceptions to the 24-donor per year rule, Service Area (Proposed § 486.308)
other sections of the proposed rule. including the exception for an OPO that
Specifically, requirements for OPO serves an entire state. (See Requirements for the designation of
advisory boards and boards of directors § 486.307(d)(2)(ii).) When the current one OPO for each service area would be
have been moved to proposed § 486.324 regulations were published in 1996, the moved from § 486.316 to proposed
(‘‘Administration and governing body’’). average OPO recovered 77 donors per § 486.308. Many requirements would
Requirements for agreements with year. Because of a decrease in the remain unchanged. However, we
hospitals, critical access hospitals, and number of OPOs and an increase in the propose replacing the ‘‘tie-breaker
tissue banks can be found in proposed number of donors recovered criteria’’ used to designate an OPO
§ 486.322 (Relationships with hospitals, nationwide, the average OPO procured when two or more OPOs apply for the
critical access hospitals, and tissue approximately 100 donors in 2002. same area with new criteria found in
banks). Requirements for testing of Therefore, we believe that an OPO proposed § 486.316 (‘‘Re-certification
donors and organs can be found in both procuring fewer than 96 donors in a 4- and competition processes’’). (See
proposed § 486.344 (Donor evaluation year period is too small to operate discussion of proposed § 486.316 in this
and management and organ placement efficiently and effectively. preamble for a discussion of the
and recovery) and proposed § 486.346 We propose removing language from proposed criteria.)
(Organ preparation and transport). the current regulations that refers to Changes in Ownership or Service Area
Requirements for data reporting have new entities or organizations becoming (Proposed § 486.310)
been moved to proposed § 486.328 OPOs. Section 371(a) of the PHS Act
The requirements for an OPO
(Reporting of data), and requirements provides authority for the Secretary to
changing ownership or changing its
for protecting privacy of data can be make grants to qualified OPOs that are
service area found in § 486.318 would
found in proposed § 486.330 described in subsection (b). However,
be moved to proposed § 486.310. Many
(Information management). Finally, given the provision in (b)(1)(D) added
requirements would remain unchanged.
requirements for professional education by the OPO Certification Act of 2000
However, we propose requiring certain
can be found in § 486.326 (Human (‘‘notwithstanding any other provision
additional information if there is a
resources). Our rationale for these of law, has met the requirements of this
change in ownership of an OPO. The
proposed changes is addressed later in section and has been certified or re-
OPO would be required to provide
this preamble in our discussion of the certified by the Secretary within the
information specific to the board
individual sections. previous 4-year period as meeting the
structure of the new organization to
In addition, we propose requiring performance standards to be a qualified
ensure that all required representatives
OPOs to file a cost report within 5 organ procurement organization* * *’’),
are included. In addition, the OPO
months following the end of the fiscal it appears impossible for the Secretary
would be required to submit operating
year, rather than the current 3 months. to give a grant to an organization that
budgets, financial information, and
This would conform the OPO was not one of the 59 OPOs that was
other written documentation we
regulations to § 413.24(f). certified by the Secretary as meeting the
determine to be necessary for
performance standards in the 4-year
OPO Service Area Size Designation and designation to ensure that the OPO
period before January 1, 2000.
Documentation Requirements (Proposed continues to meet the requirements for
Therefore, we propose removing the designation.
§ 486.306)
language at § 486.307(d)(2)(iv) that
The requirements contained in this requires an entity to show that it can De-Certification (Proposed § 486.312)
section would be re-designated from the procure organs from at least 50 potential [If you choose to comment on this
current § 486.307, and many donors per year if it was not previously section, please include the caption ‘‘De-
requirements would remain unchanged. designated as an OPO. We also propose certification’’ at the beginning of your
We would no longer require OPOs to removing references related to comments.]
provide population data to us since designation of or requirements for Many of the requirements contained
population would no longer be used as entities or organizations that are not in § 486.325 (‘‘Termination of agreement
a basis for OPO certification. currently OPOs with CMS’’) would be moved to
We propose retaining the requirement Additionally, we would remove proposed § 486.312, but the title of the
that an OPO must procure organs from obsolete service area size standards for section would be changed to ‘‘De-
an average of at least 24 donors per periods during 1996 and before. We certification,’’ to reflect the fact that if
calendar year. We believe it is important would change the current requirement an OPO’s agreement with us ends
to retain this requirement to assure that for submission of information about (whether through voluntary or
each OPO has ‘‘a defined service area of acute care hospitals that have an involuntary termination or non-renewal
sufficient size to assure maximum operating room and the equipment and of the OPO’s agreement), we would de-
effectiveness in the procurement and personnel to retrieve organs to certify the OPO.
equitable distribution of organs* * *’’ submission of information about The paragraph titled ‘‘Voluntary
as Congress intended. (See section hospitals that have both a ventilator and termination’’ would remain
371(b)(1)(F) of the PHS Act.) In an operating room, since we propose substantially unchanged, but the
addition, we would change the current requiring OPOs to have agreements with paragraph would be renamed ‘‘De-
requirement for an average of 24 donors 95 percent of those hospitals. (See certification due to voluntary
per calendar year in the 2 years before discussion in this preamble of termination of agreement.’’
the year of re-designation to a § 486.322, Relationships with hospitals, Additionally, we would add language to
requirement for an average of 24 donors critical access hospitals, and tissue indicate that we would de-certify the
per calendar year in the 4 years before banks). Finally, we would increase the OPO as of the effective date of the
the year of re-designation because the designation period from 2 years to 4 voluntary termination. The paragraph
titled ‘‘Involuntary termination’’ also meet the conditions for coverage, and OPO might have evidence that its ability
would remain substantially unchanged, any resulting appeals were governed by to obtain consent from families of
but the paragraph would be renamed regulations at 42 CFR part 498. If an potential donors was adversely affected
‘‘De-certification due to involuntary OPO failed the outcome performance by certain demographic factors in its
termination of agreement.’’ standards set forth in 486.310, we de- service area, such as the presence of a
Additionally, we propose adding certified the OPO as of August 1 of the significant number of citizens whose
language to indicate that we would de- year following the end of the re- race, ethnicity, religion, or educational
certify the OPO as of the effective date certification cycle. Although the OPO level may be associated with lower rates
of the involuntary termination. was given the right to appeal under part of consent to organ donation. As another
We propose adding a paragraph titled, 498, it was not possible to complete the example, an OPO might have evidence
‘‘De-certification due to non-renewal of appeals process prior to expiration of that its ability to recover and transport
agreement,’’ which states that we will our agreement with the OPO on August organs to transplant centers while they
not renew an OPO’s agreement if the 1. Therefore, we opened the OPO’s are still viable for transplantation was
OPO fails to meet the outcome measures service area to competition from other hampered by the remote location of
at § 486.318 based on data from the most OPOs as soon as the OPO was notified many of its donor hospitals.
recent re-certification cycle or if the about the de-certification. The existing Since most OPOs have some factors in
OPO is no longer designated for the time frame generally did not permit a their service areas that work against
service area. In that case, we would de- decision to be made on an appeal prior organ donation, the failing OPO would
certify the OPO as of the ending date of to a successor OPO taking over the need to demonstrate not only the
the agreement. We propose removing service area when the de-certified OPO’s specific factors that affected its ability to
the paragraph titled, ‘‘Appeal right,’’ agreement with us expired on August 1. meet the outcome measures but also
because we propose a new appeals In order to resolve this problem, we what it did to attempt to ameliorate the
process in § 486.314. propose to make changes to the appeals factors. For example, if an OPO
In proposed § 486.312(d), we have process and alter the timing of the provided data to show that it has a high
retained our general policy of providing competition. Specifically, we would: (1) minority population that historically
an OPO with at least 90 days notice Delay competition until an appeal is has had a lower rate of consent to
before a de-certification would be completed; (2) expedite appeals by donation, the OPO would have to
effective. However, we propose that in using a CMS hearing officer; and (3) demonstrate what it did to address the
cases of urgent need, notice of de- extend an OPO’s agreement beyond situation (such as conducting targeted
certification would be given at least August 1 if necessary. public education) and whether these
three days before de-certification. We In the OPO Certification Act of 2000, efforts were successful.
expect that cases where an OPO would Congress specified that we must Evidence submitted by an OPO about
need to be replaced based on urgent propose a process whereby an OPO substantive factors could include, but
need would be extremely rare. could appeal a de-certification on would not be limited to, research
Nevertheless, in unusual circumstances, substantive or procedural grounds. (See studies, demographic studies, data from
this expedited time frame may be section 273(b)(D)(ii)(IV).) Therefore, we the OPO’s QAPI program, and
necessary to protect the public health. are proposing a process whereby an information on the OPO’s public and
The notice to the OPO would OPO facing de-certification due to professional education and hospital
specifically state the reason for de- involuntary termination or non-renewal development activities.
certification and the effective date. We of its agreement with us would be able In making an appeal on procedural
propose changing the title of the to appeal the de-certification on grounds, an OPO could, for example,
paragraph, ‘‘Effects of termination’’ to substantive or procedural grounds and provide evidence that incorrect data
‘‘Effects of de-certification.’’ We propose receive a decision on its appeal before were used by us to determine whether
retaining the paragraph, ‘‘Public its service area was opened for the OPO met the outcome measures.
Notice,’’ but we would add language competition from other OPOs. We We propose that if the hearing officer
that states we would give public notice believe the proposed appeals process reversed our determination to de-certify
of involuntary termination or non- would be both fair and expeditious. an OPO in a case involving the
renewal of agreement in local An OPO would have 30 calendar days involuntary termination of the OPO’s
newspapers in the OPO’s service area. from the date on the notice of de- agreement, we would not de-certify the
Finally, we propose eliminating the certification to submit an appeal to a OPO. An OPO that was successful in its
paragraph, ‘‘Reinstatement’’ because our CMS hearing officer. In the appeal, the appeal would have a right to compete
proposed appeals process sets forth the OPO would be given the opportunity to for this service area for the next cycle.
process we would use for an OPO submit evidence to show why it should If the de-certification determination
whose de-certification was reversed by not be decertified. Appeals could be was upheld by the hearing officer,
a CMS hearing officer. If a hearing based on substantive and/or procedural Medicare and Medicaid payment would
officer upheld a de-certification, we grounds. Within 2 weeks of receipt of not be made for organ procurement
would not voluntarily reinstate the de- the OPO’s appeal, the CMS hearing services the OPO furnished on or after
certified OPO. Thus the current officer would schedule a hearing. The the effective date of de-certification. The
language regarding reinstatement would hearing officer would issue notice of his unsuccessful OPO would not be
no longer be needed. or her decision to the OPO by certified permitted to compete for the service
mail within 2 weeks following the date area, or any other service area.
Appeals (Proposed § 486.314) of the hearing. As stated earlier, OPOs currently have
[If you choose to comment on this In making an appeal on substantive the right to appeal a de-certification
section, please include the caption grounds, an OPO could submit evidence under part 498, which sets forth
‘‘Appeals’’ at the beginning of your of factors that negatively impacted organ procedures for providers and suppliers
comments.] donation in its service area and to appeal decisions that affect
Under existing regulations, an prevented it from meeting the outcome participation in the Medicare program.
agreement with an OPO could be or process performance measures or Since this proposed rule includes an
involuntarily terminated for failure to other requirements. For example, an appeals process for OPOs that is
separate from the part 498 process, we considered to be organs that were requirement to provide a process for an
propose that if a hearings officer denied transplanted into Medicare OPO to appeal a de-certification on
an OPO’s appeal, the OPO would have beneficiaries. Since approximately 64 substantive and procedural grounds.
no further administrative appeal rights. percent to 74 percent of extra-renal Although the process is streamlined to
Thus, we propose removing OPOs from organ transplant centers and allow an OPO to receive a decision on
the definition of suppliers found at approximately 100 percent of kidney its appeal before the effective date of the
§ 498.2. transplant centers are Medicare de-certification and before its service
However, we note that section 901 of approved, the Medicare program area being opened for competition, it
the Medicare Prescription Drug, reimburses OPOs for their excess costs allows ample time for the OPO to
Improvement, and Modernization Act for most of the organs they recover. prepare and present evidence of the
(MMA) defines the term ‘‘supplier’’ to Thus, the legal relationship between an substantive or procedural basis for its
mean ‘‘unless the context otherwise OPO and the Medicare program is appeal. Furthermore, the process allows
requires, a physician or other different from other ‘‘suppliers’’ and sufficient time for a hearing officer to
practitioner, a facility, or other entity reflects important statutory differences. consider the evidence and make a fair
(other than a provider of services) that The MMA also requires the Secretary decision that affords all of the process
furnishes items or services under this to establish in regulations a provider that is due to the OPO, while
title [title XVIII].’’ Nevertheless, the and supplier enrollment process that safeguarding our ability to remove and
unique nature of OPOs and their special includes an appeals process. Section replace an OPO that has not performed
role in the Medicare program 936 of MMA states that suppliers well.
distinguishes them from other suppliers. ‘‘whose application to enroll (or, if
Typically, suppliers furnish medical applicable, to renew enrollment) under Re-Certification and Competition
items and services directly to Medicare this title is denied may have a hearing Processes (Proposed § 486.316)
beneficiaries and obtain direct payment and judicial review of such denial under [If you choose to comment on this
for Medicare-covered items and services the procedures that apply under section, please include the caption ‘‘Re-
from a Medicare carrier. A supplier may subsection [1866](h)(1)(A) to a provider certification and competition’’ at the
furnish one or more of the health care of services that is dissatisfied with a beginning of your comments.]
items included within the definition of determination by the Secretary. Congress stated in the congressional
‘‘medical and other health services’’ that Although the appeals process we findings associated with section 219 of
are defined in section 1861(s) of the Act propose for OPOs differs from the MMA the Consolidated Appropriations Act,
and are included in the scope of the part appeals process, it specifically 2001 that the OPO re-certification
B program. (See section 1832 of the addresses the congressional findings process ‘‘created a level of uncertainty
Act.) Many suppliers do not have a associated with the OPO Certification that is interfering with the effectiveness
formal participation agreement with the Act of 2000 that the uncertainty of the of organ procurement organizations in
Secretary. (See section 1842(h) of the current re-certification interferes with raising the level of donation.’’ Under
Act.) In contrast, an OPO is required to the effectiveness of OPOs in raising the existing regulations at § 486.310 and
have an agreement with the Secretary. level of donation. This alternative § 486.316, the service area of every OPO
(See 42 U.S.C 273(b)(1)(C).) Moreover, appeals process is necessary because was opened for competition at the
many, if not most, organ donors are not there is a limited time period from the conclusion of every re-certification
Medicare beneficiaries, and many date that the outcome performance cycle, regardless of whether the OPO
organs recovered by OPOs are not measure data are available to the date met the outcome performance standards
transplanted into Medicare when the OPO contract cycle ends. for the prior re-certification cycle. Any
beneficiaries. Therefore, to achieve the goals of the OPO that met the performance
Given this framework, and to ensure 2000 legislation, including providing an standards for the prior re-certification
that Medicare pays appropriately for its equitable process for appeals, OPO cycle was eligible to compete for an
share of organ acquisition costs, OPOs appeals must be expedited and open service area or a portion of an
have payment rules and methodologies completed before a replacement OPO is open service area.
that differ from the payment rules and named in order to avoid disruption in Under existing OPO regulations, an
methodologies used for other suppliers. organ procurement. OPO that failed to meet the outcome
(See, for example, 42 CFR § 413.200.) Under our proposed rule, if the measures would lose its service area and
Among other differences, organ hearing officer upheld a de-certification be de-certified. Its service area would be
acquisition costs are not paid directly by determination, we would open the opened for competition from all OPOs
a carrier to an OPO. Instead, the OPO is OPO’s service area for competition from that met the outcome performance
paid by the transplant hospital, subject other OPOs. The de-certified OPO standards. If no OPO that met the
to later adjustment (see 42 CFR would not be permitted to compete for outcome performance standards was
413.200(c)(iv)), and Medicare pays the the open area, and in most cases, the de- willing to accept responsibility for the
transplant hospital for the organ certification would be effective as of the service area, the OPO that failed the
acquisition costs. If necessary, Medicare ending date of the OPO’s agreement outcome performance measures would
payment to the OPO is adjusted after it with us. be re-designated for the service area if
files its yearly cost report; for example, However, if the appeals process did it submitted an acceptable corrective
if the OPO’s costs to recover organs not leave sufficient time for us to action plan to us.
exceeded the payments it received for conduct a competition process for the Under existing regulations, if more
the organs, Medicare covers the open area and provide for a smooth than one OPO that met the performance
additional costs, based on the transition of the service area to the standards wanted to take over the
percentage of organs that were successor OPO, we could, at our service area or part of the service area
recovered and transplanted into discretion, extend the OPO’s agreement of another OPO, we used six
Medicare beneficiaries. However, for with us for a period of time not to ‘‘tiebreaker’’ criteria to determine which
purposes of the adjustment, all organs exceed an additional 60 days. OPO should be awarded the service
provided by the OPO to Medicare- We believe the appeals process we area. The tiebreakers were: (1) Prior
approved transplant centers are propose fully satisfies the statutory performance, including the previous
year’s experience in terms of the in the re-certification process that was not de-certified. Second, we would
number of organs retrieved and wasted noted by Congress. The limitations allow competition only for entire
and the average cost per organ; (2) would ensure that: (1) The process can service areas. A service area could be
actual number of donors compared to be completed expeditiously; (2) divided only if the incumbent OPO was
the number of potential donors; (3) the disruptions to service areas will be de-certified and no OPO wanted to
nature of relationships and degree of minimized; and (3) an OPO may accept responsibility for the service
involvement with hospitals in the compete for an open area only if it is area. In such case, we could, at our
organization’s service area; (4) bed likely to be able to improve organ discretion, choose a single OPO to take
capacity associated with the hospitals donation in the service area. over the service area or adjust the
with which the organizations have a The proposed competition process
service area boundaries of two
working relationship; (5) willingness would differ somewhat, depending
upon whether a service area was opened contiguous OPOs to incorporate the
and ability to place organs within the
service area; and (6) proximity of the for competition because the incumbent open area. Finally, we are proposing to
organization to the donor hospitals. OPO was de-certified or because of the use specific clear, objective criteria for
As stated earlier in this preamble, we wider competition process taking place determining which OPO would be
propose opening every OPO’s service at the end of a re-certification cycle. selected for a service area.
area for competition at the end of every First, we would permit OPOs to The chart below shows how the
re-certification cycle as we did under compete for open areas only if they met process would differ. Following the
the existing regulations. However, we certain specific objective criteria. These chart is a more detailed explanation of
are proposing certain limitations that we criteria would vary, depending upon our proposal.
believe would address the uncertainty whether the incumbent OPO was or was
Incumbent OPO
Incumbent OPO Can service area Criteria OPOs must meet to compete
permitted to com- Criteria CMS uses to choose OPO
decertified? be divided? for open area
pete?
Yes ......................... No ......................... Yes, at discretion 4 out of 5 outcome performance Acceptable plan to increase organ do-
of CMS. measures at or above the mean. nation in open area.
No .......................... Yes ....................... No ......................... 4 out of 5 outcome performance Acceptable plan to increase organ do-
measures at or above the mean. nation in open 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- failing OPO. That is, the overall actual increase in organ donation. An
Certified performance of an OPO that meets 4 out OPO with a tissue bank may want a
of 5 outcome performance measures at section of another OPO’s service area
We propose that if we notify an OPO
or above the mean would be, at the that has particularly high tissue
that it will be de-certified because its
least, approximately 25 percentage donation potential in hopes of
agreement will be terminated or will not
points higher overall than the expanding its tissue bank into the area.
be renewed and the OPO does not
performance of an OPO that is de- Because of the problems created by
appeal within the time frame specified
certified because it did not meet 4 out allowing competition for partial service
in § 486.314(a) or the OPO appeals but
of 5 outcome performance measures at areas, we believe it is critically
the de-certification is upheld (see important to require OPOs to compete
§ 486.314(c)), we would open the OPO’s 75 percent of the mean. We propose
establishing the threshold at 100 percent for entire service areas.
service area for competition from other If no OPO applied to compete for the
OPOs. An OPO’s service area would not of the mean for 4 out of 5 outcome
performance measures because we service area of a de-certified OPO, we
be opened for competition until the could select a single OPO to take over
conclusion of the proposed appeals believe that an OPO whose performance
is at or above the mean would have the the entire open area or adjust the service
process. area boundaries of two or more
Only OPOs that meet 4 out of 5 expertise needed to take over a failing
OPO’s service area and improve organ contiguous OPOs to incorporate the
outcome performance measures at or open area. CMS would select an OPO
above the mean for the preceding re- donation.
based on the OPO’s success in meeting
certification cycle would be eligible to OPOs would be permitted to compete the process performance standards
compete for the open service area of a only for entire service areas. We have during the preceding re-certification
de-certified OPO. The de-certified OPO found that permitting competition for cycle
would not be permitted to compete for partial service areas provides an
its service area, or any other service incentive for OPOs to attempt to ‘‘raid’’ Competition When OPO Has Not Been
area. Competing OPOs would be portions of neighboring service areas for De-Certified
permitted to compete only for the entire purely business reasons, with no regard We propose that all OPO service areas
service area. to whether the OPO can increase organ would be opened for competition at the
By requiring an OPO to have attained donation in those areas. For example, end of every re-certification cycle. Once
the mean or greater in 4 out of the 5 an OPO may wish to take over counties we determined that an OPO met the
outcome performance measures in order in a neighboring service area where outcome measures at § 486.318 for the
to compete for the open area of a de- hospitals demonstrate high conversion previous re-certification cycle and was
certified OPO, we would limit rates, which would improve the found to be in compliance with the
competition to OPOs that have competing OPO’s overall outcome process performance measures and
performed significantly better than the performance measures but lead to no other requirements at §§ 486.320
through 486.348, CMS would open the donation in the open service area would as long as there are strict criteria for
OPO’s service area for competition from be used by us to assist in identifying the selecting the OPOs that are permitted to
other OPOs. most effective organization to maximize compete for open areas.
To compete for open areas, OPOs organ donation in the open area. We have found that completely
would be required to meet certain Given the constraints imposed by unrestrained competition for OPO
criteria based on data from the geography, as well as the variation in service areas can damage collaborative
preceding re-certification cycle. An OPO OPO performance, resources, and relationships, impede sharing of best
would be required to meet the ability, we believe the process we practices across OPOs, and, as a result,
following: (1) 4 out of 5 outcome propose would result in the selection of degrade OPO quality. As a consequence
performance measures at or above the the OPO or OPOs most likely to improve of the Breakthrough Collaborative,
mean; and (2) a conversion rate of organ donation rates in an open area. OPOs have forged an impressive
potential donors to actual donors at As stated earlier in this preamble, we number of collaborative relationships.
least 15 percentage points higher than expect that our proposal would permit OPOs are eagerly sharing best practices
the conversion rate of the OPO currently the competition process to be completed and providing assistance to fellow OPOs
designated for the service area. (The expeditiously. Agreements expire on in solving problems and reducing
conversion rate is the first of the five July 31 of the year following the end of barriers to donation. For the first time,
outcome performance measures.) OPOs the re-certification cycle (for example, many OPOs are seeing themselves not
would be required to compete for an the current re-certification cycle ends just as individual businesses but as
entire service area. The incumbent OPO December 31, 2005, and our agreements participants in a widespread campaign
would be permitted to compete for its with OPOs expire July 31, 2006), giving to save lives by increasing organ
own service area. us only 7 months to complete the many donation. We believe it is critical that
To illustrate how this process would steps necessary to re-certify OPOs and the competition process we use to re-
work, we provide the following renew their agreements with CMS. To certify OPOs does not damage these
example: reduce the uncertainty in the re- collaborative relationships. Therefore,
OPO A’s service area is opened for certification process identified by we are requesting comments on the
competition. The OPO met 4 out of 5 Congress, it is important that the following competition options.
outcome performance measures at or competition process be completed as One option would be a highly
above the mean for the preceding re- quickly as possible so that OPOs know restricted competition process in which
certification cycle. Its conversion rate whether they will retain their service only service areas of OPOs that did not
was 109 percent of the mean. A survey areas for an additional 4 years. meet the conditions for coverage (that is,
of the OPO determined that it met all We expect that the OPTN and SRTR the outcome performance measures at
process performance measures. Two will need a minimum of 2 months to § 486.318 or the process performance
OPOs would like to compete for OPO finalize the OPO outcome performance measures and other requirements at
A’s service area. Both OPOs met 4 out measure data after the close of a re- §§ 486.320 through 486.348) would be
of 5 outcome performance measures at certification cycle on December 31. This opened for competition. Any OPO that
or above the mean and both met all would leave at most 5 months for us to met the conditions for coverage would
process performance measures. OPO B’s analyze the data, determine whether be re-certified, re-designated for its
conversion rate was 117 percent of the each OPO met or did not meet the service area, and its agreement with
mean, and OPO C’s conversion rate was requirements for re-certification, notify CMS would be renewed for another 4
125 percent of the mean. OPO C is OPOs of their status, open service areas years. This competition process would
permitted to compete for OPO A’s open for competition, provide sufficient considerably reduce the uncertainty in
area because its conversion rate is 16 opportunity for OPOs competing for a the re-certification process that was
percentage points higher than OPO A’s service area (including the incumbent identified by Congress. However, this
conversion rate. OPO B is not permitted OPO) to develop and submit a plan to process would nearly eliminate
to compete for the open service area increase organ donation, review plans, desirable competition that we believe
because its conversion rate is only 8 designate an OPO for each service area can create an incentive for OPOs to
percentage points higher than OPO A’s that is under competition, notify OPOs perform optimally.
conversion rate. In selecting an OPO for of their status, and conduct transitional We are soliciting comments on
the service area, we would consider activities, as needed. variations of the proposed limited
each OPO’s success in meeting the We believe that our proposed process competition process for OPOs whose
process performance measures during would facilitate the timely completion service areas would be opened for
the prior re-certification cycle, as well of the competition for three reasons: (1) competition at the end of a re-
as submission of an acceptable plan to The process we propose is simple and certification cycle (with the exception of
increase organ donation in the open straightforward; (2) the requirements we OPOs whose service areas would be
service area. propose for OPOs to compete for an opened due to de-certification). Under
We propose that an acceptable plan open area are unambiguous and, these options, all service areas would be
would, at a minimum: (1) Be based on therefore, unlikely to lead to opened for competition, but the criteria
the competing OPO’s experience in its misunderstandings that could impede OPOs would be required to meet to
own service area; (2) include an analysis the process; and (3) the requirements for compete for open areas would differ.
of existing barriers to increasing organ competition, as well as the prohibition Under alternative one, an OPO would be
donation in the open area, both internal against dividing service areas, would act permitted to compete for an open area
(for example, high staff turnover) and to limit the number of OPOs permitted if its conversion rate was a least 15
external (for example, language barriers to or interested in competing for open percentage points higher than the
due to a high number of recent areas. conversion rate of the OPO currently
immigrants in the OPO’s service area); We propose opening all OPO service designated for the service area. This
and (3) provide a detailed description of areas at the end of every re-certification alternative would not require that an
specific activities and interventions for cycle because we believe that healthy OPO meet a minimum outcome
increasing organ donation in the open competition between OPOs can lead to performance measure standard. It
area. An OPO’s plan to increase organ improvements in quality and outcomes, would allow more OPOs to compete for
open areas. However, this alternative other related factors in each OPO’s standard’’ for estimating the number of
would allow OPOs whose performance service area. Many factors can affect the potential organ donors (as long as they
is below the mean to compete for open number of potential donors in a service are conducted with a standardized
areas. area, such as a large elderly population, protocol by uniformly trained
Alternative two is a limited a low motor vehicle accident rate, or a reviewers), they are, as the GAO noted,
competition process similar to the one high incidence of the Human relatively labor intensive, time
we propose in this proposed rule, except Immunodeficiency Virus/Acquired consuming, and expensive. Therefore,
that a competing OPO would be Immune Deficiency Syndrome (HIV/ CMS concurred with GAO’s
required to meet 120 percent of the AIDS). These factors are likely to reduce recommendation to investigate
mean, rather than 100 percent of the the number of potential organ donors, alternatives for determining donor
mean, for 4 out of 5 outcome whereas factors such as a high homicide potential.
performance measures. Under this rate or a high motor vehicle accident
1. Regression Models for Estimating
alternative, an OPO still would be rate are likely to increase the number of
Donor Potential
required to have a conversion rate at potential donors.
least 15 percentage points higher than Harvard and the Partnership for Organ
B. Evaluation of Alternative Methods for Donation developed their model based
the conversion rate of the OPO Determining Organ Donor Potential
designated for the service area. It is on their 1993 study of 89 hospitals in
likely that very few OPOs would be able In a 1997 report, ‘‘Organ Procurement 3 OPO service areas, using regression
to compete for open areas under this Organizations: Alternatives Being analysis to test hospital characteristics
competition process, but the strict Developed to More Accurately Assess as predictors of the number of potential
criteria would ensure that only the very Performance,’’ the U.S. General organ donors. Their analysis
best OPOs could compete for open Accounting Office (GAO) explored demonstrated that four hospital
areas. options for assessing OPO performance characteristics used together could be
We believe that the limited and recommended that CMS consider used to predict organ donation
competition process we propose, if developing new outcome measures potential: Number of staffed beds,
implemented, would encourage healthy based on the number of potential donors trauma center certification, medical
competition that improves OPO quality in an OPO’s service area. The report school affiliation, and Medicare case-
and functioning and would lead to discusses the feasibility of replacing mix index (a measure of the complexity
population with: (1) The number of of cases treated in the hospital). The
increased organ donation and
deaths in an OPO’s service area; (2) the model was validated using death record
transplantation. We are requesting
number of deaths adjusted for age and reviews, and a study was conducted to
comments on the proposed and
cause of death; (3) an estimate of the verify the accuracy of the death record
alternative forms of competition in this
number of potential donors in an OPO’s reviews (an interrator reliability study).
proposed rule. Specifically, we are
service area determined by statistical The results of the study were published
requesting comments regarding the
modeling; or (4) the number of potential in the ‘‘American Journal of Public
effect of competition on increasing
donors determined by death record Health’’ in November 1998. (C
organ donation, especially in service
reviews. Christiansen, S Gortmaker, J William, et
areas of poorly-performing OPOs, and The GAO report noted that both the al.: A Method for Estimating Solid
on the collaborative relationship among number of deaths and the number of Organ Donor Potential by Organ
OPOs. deaths adjusted for age and cause of Procurement Region, American Journal
Proposed OPO Outcome Measures death are a better indicator of the of Public Health, Vol. 88, No. 22,
number of potential donors than November, 1998.)
[If you choose to comment on this population because they eliminate a Like the Harvard/Partnership model,
section, please include the caption large portion of the population that an the AOPO model was developed using
‘‘Outcome Measures’’ at the beginning OPO cannot consider for organ regression analysis to test the validity of
of your comments.] donation. However, the GAO pointed various hospital characteristics as
Condition: Outcome Measures out that there are significant drawbacks predictors of donor potential. The
(Proposed § 486.318) to using either deaths or deaths adjusted AOPO model estimates the number of
for age and cause of death, including potential donors based on three factors:
A. Current Outcome Performance
lack of timely data and the inability to Whether the hospital has neurosurgery
Standards
identify those deaths suitable for use in services; whether it has an emergency
Currently, five quantitative organ donation. For example, although room; and whether it is a non-profit or
performance standards are used in the National Center for Health Statistics for-profit entity. AOPO developed its
evaluating OPO performance: number of (NCHS) collects death data from States, model based on death record reviews in
donors, kidneys procured, kidneys Oklahoma, and Puerto Rico do not hospitals in 16 OPO service areas. (The
transplanted, extra-renal organs report their deaths, and there is an 18 study began with 30 OPOs, but 14
procured, and extra-renal organs to 24 month lag in the availability of furnished incomplete data and their
transplanted. Each of these outcome death data from the NCHS. data were not included in many of the
performance standards is calculated per The GAO recommended that CMS analyses AOPO used to develop its
million population, and OPOs are investigate the development of two model.) An interrator reliability study to
ranked accordingly. An OPO must be at different models for estimating the determine the accuracy of the OPOs’
or above 75 percent of the national number of potential donors in an OPO death record reviews has not been
mean for at least 4 out of 5 performance service area. One of these models was conducted.
standards in order to be re-certified. developed by the Harvard School of In 1999, we contracted with the
Congress directed that our new Public Health and the Partnership for Harvard School of Public Health to
regulations include multiple outcome Organ Donation, and the other was apply the Harvard/Partnership model in
measures that are based on empirical developed under the auspices of the all OPOs nationwide. In 2000, after
evidence, obtained through reasonable AOPO. Although death record reviews receiving Harvard’s results, we
efforts, of organ donor potential and are acknowledged to be the ‘‘gold compared the number of potential
donors estimated by the Harvard model potential donors in a hospital (the the number of potential donors in eight
with the number of potential donors dependent variable). OPO service areas that have only a small
estimated by the AOPO model. (Both The development of a regression number of hospitals.
Harvard and AOPO used 1998 data.) We model involves: (1) Initial selection of As an example, Harvard estimated
also compared the number of potential variables that are believed to have that one small OPO had 96 potential
donors estimated by the two models in predictive potential; (2) collecting and donors in 1998, with a confidence
the 16 OPOs included in the AOPO organizing the data on the chosen interval width of 120; that is, one can be
study with the results from reviews of variables; (3) testing the correlation 95 percent confident that the actual
1998 death records in those 16 OPOs’ between the variables; (4) choosing number of potential donors was
service areas conducted as part of the independent variables with a low degree between 36 and 156. Similarly, AOPO
AOPO study. (Although AOPO has not of correlation between themselves and a estimated that a small OPO had 57
conducted an interrator reliability study high degree of correlation with the potential donors with a confidence
to verify the accuracy of the death dependent variable; and (5) validating interval width of 82; that is, one can be
record reviews, for purposes of this the results against results obtained 95 percent confident that the actual
analysis, we assumed AOPO’s death through a previously tested method (for number of potential donors was
record reviews accurately estimated the example, through death record reviews). between 16 and 98. Obviously, it would
number of potential donors in each The objective is to develop a model that be problematic to use estimates with
OPO’s service area during 1998.) uses the least amount of independent such large confidence intervals for
When compared to the number of variables necessary to have the greatest certifying OPOs.
potential donors determined by AOPO amount of predictive capability and However, even for large OPOs, the
through death record reviews, neither which uses data that can be updated two models produce ranges that are
the Harvard model nor the AOPO model routinely from existing sources, such as unacceptably large for certification
consistently predicted the number of AHA data. However, the model cannot purposes. One of the largest of the 16
potential donors in individual OPO be used indefinitely without OPOs in the AOPO study was estimated
revalidation to determine whether the to have 395 potential donors with an
service areas. In AOPO’s study of 16
independent variables remain interval width of 93, that is, one can be
OPOs, estimates ranged from 18.6
predictive. Thus, in order to use the 95 percent certain that the number of
percent lower than the number of
Harvard and AOPO regression models potential donors was between 349 and
potential donors determined by death
for certification purposes, they would 442. Harvard estimated that the same
record reviews to an estimate that was
have to be revalidated periodically OPO had 740 potential donors, with an
47.7 percent higher than the number of
using death record reviews. interval width of 312, that is, one can be
potential donors determined by death
Since they are based on regression 95 percent certain that the number of
record reviews. The Harvard model’s
analysis, both models produce an potential donors was between 583 and
estimates ranged from 14.3 percent
estimate of potential donors with a 896.
lower to 184 percent higher. range (plus or minus) within which, Overall, the Harvard model estimates
The failure of the two models to statistically, there is a 95 percent a much larger number of potential
accurately estimate the number of probability that the true number of donors than the AOPO model for most
potential donors may be due to many potential donors lies. This range is individual OPO service areas. The
factors, including the accuracy (or called the ‘‘confidence interval.’’ The Harvard model also estimates a much
inaccuracy) of information about range of the confidence interval is larger pool of donors nationwide than
hospital characteristics obtained by the determined as illustrated in the the AOPO model—11,700 to 21,800
researchers from a variety of sources, following example. If the number of potential organ donors annually to
such as interviews with hospital staffs potential donors based on regression AOPO’s 11,000 to 14,000 potential
and American Hospital Association analysis is determined to be 100 and the donors annually. It is certainly possible
(AHA) data. Additionally, there were confidence interval is 46, the range of to debate the reasons for the disparities
differences in criteria for hospitals’ the confidence interval is calculated by in estimates between the two models
inclusion in the study between the subtracting one half of the confidence (both nationwide and in individual
original Harvard study and the CMS- interval from the number of potential service areas). For example, the Harvard
contracted study, as well as differences donors (that is, one half of 46 is model was tested and validated in only
between those studies and the AOPO subtracted from 100 (100–23=77)) and 3 OPO service areas, whereas the AOPO
study. adding one half of the confidence model was tested and validated in 16
However, the primary reason the interval to the number of potential and, thus, may be more accurate.
models produced such imprecise donors (that is, one half of 46 is added However, regardless of the reason for
estimates is that they are based on to 100 (100+23=123)). Thus, the range of the difference in estimates of the
regression analysis. Regression analysis the confidence interval in this example number of potential donors between the
is a method for estimating the statistical would be between 77 and 123, and one two models, the central fact remains
association between a group of could be 95 percent certain that the that they are unreliable estimates and,
independent (or predictor) variables and number of potential donors was therefore, unacceptable for OPO
a dependent (or outcome) variable. between 77 and 123. certification purposes.
Regression analysis can be used to test The wider the confidence interval, the To demonstrate the effect of using
a hypothesis by determining how a less certainty there is that the model those estimates to rate an OPO’s
change in one or more of the works well as an estimate of the number performance, we can look at the large
independent variables affects the value of potential donors in a particular OPO’s OPO that was estimated by the AOPO
of the dependent variable. Both the service area. Large intervals generally study to have 395 potential donors and
Harvard and AOPO researchers tested occur in OPO service areas with a small use a hypothetical example to suppose
the effect of a variety of hospital number of estimated potential donors or that in 1998 the OPO had 180 donors,
characteristics, such as number of full a small number of hospitals. In fact, or a conversion rate (that is, the number
time equivalent positions (an Harvard has stated it does not believe its of donors from whom organs are
independent variable) on the number of model produced an accurate estimate of recovered for the purpose of
transplantation as a percentage of the 2. AOPO Recommendations be assessed using second-tier measures

number of potential donors) of The AOPO has long been a champion based on death record reviews.
approximately 46 percent. (The average of replacing population-based outcome AOPO has criticized the current
conversion rate for the 16 OPOs in the performance standards with measures population-based performance
AOPO study was 50 percent.) If, based on the number of potential standards because they fail to take into
however, the OPO’s actual number of donors. The goal of AOPO’s death account factors that negatively impact
potential donors was at the bottom of record review study was to find an the number of potential donors in an
the confidence interval (349), its alternative to population that would be individual OPO’s service area, such as
conversion rate was actually an above- a reasonably accurate measure of the high rates of HIV/AIDS and low motor
average 52 percent, but if the actual number of potential donors. However, vehicle accident and homicide rates.
number of potential donors was at the in a series of meetings with us to They argue that population-based
top of the confidence interval (442), its discuss the results of its death record measures cause some good OPOs to look
conversion rate was only 41 percent, review study, the AOPO did not like poor performers. However, the
which is well below average. recommend using either the AOPO or reverse is also true—factors in some
For smaller OPOs, the effect of the the Harvard methodologies to estimate OPO service areas, such as low rates of
confidence interval is much greater, and donor potential in individual OPO HIV/AIDS and high motor vehicle
could result in re-certification of a poor service areas. accident and homicide rates, may create
OPO or de-certification of a good OPO. Instead, in written proposals to us a relatively high donor potential,
For example, if we look at the small dated February 28, 2001 and April 25, making OPOs whose actual performance
OPO estimated by AOPO to have 57 2001, the AOPO recommended outcome is below average look like good
potential donors (with a confidence measures based on both population and performers.
The implications of this are clear. The
interval between 16 and 98 potential the number of potential donors as
two-tier method might prevent de-
donors) and use a hypothetical example determined by death record reviews.
certification of good OPOs by giving
to suppose that it had 12 donors, its AOPO’s recommended outcome
OPOs that may be disadvantaged by
conversion rate based on its estimated measures would consist of a two-tiered
population-based measures an
potential of 57 donors is an abysmal 21 system for OPO certification that would
opportunity to prove they are good
percent, and the OPO would very likely rely on population in the first tier and,
performers by submitting results from
be de-certified. If the OPO’s potential for OPOs that failed the first-tier
death record reviews. However, the two-
were at the top of the confidence measures, the number of potential
tier method would not prevent re-
interval (98 potential donors), the OPO donors determined by death record
certification of poorly performing OPOs
looks even worse—with a conversion reviews in the second tier. that may appear to be good performers
rate of only 12 percent. However, if the The AOPO recommended that we
using population-based measures.
OPO’s potential were at the bottom of retain the 5 factors currently used to In the congressional findings
the confidence interval (16 potential measure OPO performance, that is, associated with section 219 of the
donors), its conversion rate would be an donors, kidneys procured, kidneys Consolidated Appropriations Act, 2001
impressive 75 percent, and the OPO transplanted, extra-renal organs (Pub. L. 106–554), Congress directed the
would be considered a top performer. procured, and extra-renal organs Secretary to develop measures that
Our analysis of the Harvard and transplanted. They recommended that: ‘‘accurately measure performance
AOPO data showed that in some cases, (a) In the first tier, OPOs be screened differences among the organ
as would be expected, the number of using the current population-based procurement organizations.’’ We do not
potential donors as determined by performance standards, that is, OPOs believe a two-tier method with the first
AOPO’s 1998 death record reviews fell would have to meet 4 out of the 5 tier based on population is a reliably
outside the confidence interval current performance standards at 75 accurate methodology for assessing OPO
predicted by both models. Consider the percent of the mean (2 performance performance, and we do not believe re-
example of one OPO estimated to have standards at 50 percent of the mean for certification of OPOs should be based
192 potential donors using the AOPO OPOs operating exclusively in non- on an inaccurate methodology.
model (confidence interval 152–232) contiguous States or territories) to pass Furthermore, we believe it is incumbent
and 197 potential donors using the the first tier; (b) an OPO not meeting the upon the agency, as both a prudent
Harvard model (confidence interval first-tier outcome measures be required purchaser of health care services and a
135–259). According to AOPO’s death by us to submit data for all deaths guardian of the organ donation system
record reviews, the OPO’s actual occurring in hospitals in its service area in the United States, to propose an
number of potential donors was 130. with 150 beds or more; (c) OPOs be re- accurate measure of OPO performance
Using a hypothetical example, we can certified if their death record review ‘‘based on empirical evidence, obtained
suppose that the OPO had 65 donors in data indicated a conversion rate of at through reasonable efforts, of organ
1998. Thus, its conversion rate based on least 50 percent of the national mean donor potential and other related factors
the AOPO death record reviews would conversion rate found in the AOPO in each service area of qualified organ
have been 50 percent—average study of 30 OPOs (including the 14 procurement organizations,’’ as
according to the AOPO study of 16 OPOs that furnished incomplete data); Congress clearly intended in 42 U.S.C.
OPOs. However, according to the AOPO and (d) the national conversion rate be 273(b)(1)(D)(ii). Such a measure should
model, the OPO’s conversion rate would updated every 4 to 5 years. enable the Secretary and the public to
have been only 34 percent; and C. Outcome Measures distinguish between good OPOs and
according to the Harvard model, its poor OPOs.
conversion rate would have been 33 1. Problems With Two-Tier Assessment In addition to its reliance on
percent. With a threshold for re- AOPO’s recommended two-tier population-based measures in the first
certification established at 75 percent of process relies primarily on population- tier, another drawback of the two-tier
the mean 50 percent conversion rate based measures. In fact, the first tier is process proposed by AOPO is that in
(37.5 percent), the OPO could have identical to the existing performance order to use death record review results
faced de-certification. standards, and few, if any, OPOs would in the second tier, we initially would
need to calculate a national conversion organ donor eligibility criteria. Data are brain death, who do not have any of the
rate to which OPOs could be compared reported monthly for deaths occurring following clinical indications:
and then recalculate the conversion rate during the previous month. The data are • Tuberculosis.
periodically—probably every 4 to 5 obtained by the OPOs from referral calls • Creutzfeldt-Jacob disease or any
years. AOPO has suggested that we hospitals and critical access hospitals other prion-induced disease.
determine the national conversion rate are required to make to OPOs by the • Viral septicemia.
through a sample of death records from hospital CoP (see §§ 482.45 and • Rabies.
hospitals throughout the United States. 485.643) and are supplemented by data • Reactive hepatitis B surface antigen.
We believe this process would go far gathered by OPOs onsite at their • Any retro virus infection.
beyond the ‘‘reasonable effort’’ Congress hospitals. OPOs began reporting the • Active malignant neoplasms, except
envisioned for determining donor data to the OPTN in September 2001. primary central nervous system tumors
potential. and basal cell and squamous cell
In the first few months of the data
Furthermore, in order to have the carcinomas.
collection, HRSA and the OPTN found
national conversion rate available to us • Aplastic anemia.
many instances of incomplete data • Agranulocytosis.
shortly after the close of a re- reporting by the OPOS, particularly the
certification cycle, a national sample • Active viral and systemic fungal
number of deaths and imminent deaths. infections.
would have to be calculated well in However, the completeness of these data
advance of the end of the re-certification • Gangrene of bowel.
is improving. OPOs reported • Extreme prematurity.
cycle to allow us sufficient time to find approximately 900,000 deaths and
a contractor and to allow the contractor • Positive serological or viral culture
imminent deaths in 2002 (a known findings for HIV.
sufficient time to design and conduct a undercount), which is not far from the
study and analyze the results. However, • Chagas Disease.
982,914 inpatient hospital deaths Although the upper age limit for
if all OPOs passed the first tier at the reported by the National Center for
conclusion of the re-certification cycle, donation continues to rise as OPOs and
Health Statistics for 2000. The number transplant programs become
CMS would have no need of the of potential donors reported by OPOs
national conversion rate that it had increasingly willing to consider
(termed ‘‘eligible deaths’’ by the OPTN recovering and transplanting ‘‘expanded
obtained. We believe there is a simpler, and SRTR) for 2002 is consistent with
more accurate, and more reliable criteria’’ organs, almost all organs come
estimates of the annual number of from donors younger than 70. Therefore,
method of measuring an OPO’s potential donors made by the organ
performance according to its donor we propose limiting the definition of
donation community. HRSA and the ‘‘organ donor potential’’ to donors of age
potential.
OPTN continue to work with OPOs to 70 and below. We propose limiting the
2. OPTN Data as Alternative Data further improve the database. We expect definition to include only deaths from
Source that if these data are used for neurological causes (that is, brain death)
We propose eliminating the use of certification purposes, the completeness rather than including non-heartbeating
population-based standards and, of the data will approach 100 percent. donation (also called donation after
instead, basing outcome measures To assess the accuracy of the data cardiac death (DCD)). Although DCD is
entirely on organ donor potential. Organ OPOs are reporting to the OPTN, the becoming more common, it remains the
donor potential (that is, the number of SRTR recently analyzed the ability of exception; in 2000, there were only 119
potential organ donors) would be ‘‘eligible deaths’’ data to predict the non-heartbeating donors, and in 2001,
determined by data reported by OPOs to actual number of donors. They there were only 167. We are proposing
the OPTN, based primarily on referral compared ‘‘eligible deaths,’’ as well as rule-out criteria that are generally
calls the OPOs receive from hospitals. the number of potential donors accepted by the organ donation and
We believe this system would be estimated by the Harvard model with transplantation community as
simple, straightforward, and easy for the actual number of donors. The precluding organ donation because
OPOs and the public to understand. researchers found ‘‘eligible deaths’’ to these co-morbid conditions render an
Furthermore, the OPOs already report be substantially more predictive of individual medically unsuitable for
data on organ donor potential to the actual donors. The SRTR noted that organ donation. However, we are
OPTN. more complete data reporting by OPOS specifically requesting public comments
OPOs report certain data elements to to the OPTN will improve the reliability regarding our proposed definition.
the OPTN whenever they query the of the data. (‘‘New Methods for We propose using a specific term,
OPTN’s system to find a match for a Estimating Total Potential (Organ) ‘‘potential donor denominator,’’ for the
potential donor, and the OPTN has a Donors in the U.S.’’ J McGowan, M data on organ donor potential OPOs
sophisticated system in place to capture Guidinger, R Pietroski, D Gaylin, A Ojo, would report to the OPTN. The
this information electronically. As part et al. Abstract presented at American potential donor denominator would
of its efforts to monitor the impact of the Transplantation Congress meeting, indicate the number of individuals in an
hospital CoP (condition of participation) Washington DC, May 30–June 4, 2003.) OPO’s service area who meet the criteria
for organ, tissue, and eye procurement), for organ donor potential, as defined by
3. Standardized Definition of Organ
the Health Resources and Services regulations. The term ‘‘potential donor
Donor Potential
Administration (HRSA) asked the OPTN denominator’’ would differentiate the
in 2001 to begin collecting additional, Our proposed definition is based on data OPOs would report to the OPTN
hospital-specific data from OPOs, patient age, cause of death, and co- from data based on other definitions of
including the number of referral calls morbid conditions that contraindicate ‘‘potential donor’’ or ‘‘organ donor
OPOs receive from hospitals reporting donation. We would use the following potential’’ used in the OPO community.
deaths and imminent deaths, the definition of ‘‘organ donor potential’’: Because definitions vary among
number of referrals meeting organ donor the number of patients whose age is 70 OPOs, the universe of potential donors
eligibility criteria (that is, the number of or less meeting death by neurological we would use for OPO certification
potential donors), and the number of criteria, based on generally accepted could be different from that used by
consents obtained on referrals meeting practice parameters for determining some OPOs. For example, an OPO that
has liberal donor criteria (perhaps the data used for OPO certification are Therefore, in weighing the two
including recovery of non-heartbeating accurate. methods of determining the number of
donors) would consider itself to have a OPTN data also would be verified by potential donors (data reported by
larger number of potential donors than hospital surveyors when they review hospitals to OPOs and by OPOs to the
the number it reports to the OPTN for data on hospital deaths and hospital OPTN or death record reviews
the ‘‘potential donor denominator.’’ In death records to verify hospital and performed by OPOs), we believe that
these instances, OPOs would be able to critical access hospital compliance with using OPTN data most clearly fulfills
exceed 100 percent of the standard. the CoPs. In addition, since we propose Congress’s intention in requiring
Conversely, an OPO with conservative requiring OPOs to publish hospital- promulgation of measures based on
donor criteria would consider itself to specific organ donation data annually ‘‘empirical evidence, obtained through
have a smaller number of potential (see proposed § 486.328), hospitals reasonable efforts.’’ OPTN data would
donors than the number it reports to the could verify their own data to ensure provide an accurate measure of organ
OPTN. OPOs are reporting data accurately to donor potential and OPO performance,
Determining whether organs should the OPTN. Certainly, using OPTN data and using OPTN data would be simple
be recovered and transplanted is a would be both sensible and practical and straightforward because a system is
medical decision; therefore, our because the OPTN already has a system already in place to report, capture, and
proposed definition is not intended to in place to collect and verify the data, disseminate the data.
limit the donors or organs an OPO and all 59 OPOs have the capability to We propose that potential donor
recovers for transplantation. We are report the data electronically. denominator data reported to the OPTN
aware that many OPOs are successfully to be used for OPO re-certification
recovering transplantable organs from 5. Death Record Reviews as Alternative include data for all deaths that occur in
donors that do not fall within our Data Source Medicare and Medicaid participating
proposed definition. Because death record reviews are hospitals in an OPO’s service area,
considered by the OPO community to be unless a hospital has received a waiver
4. OPTN Data
the ‘‘gold standard’’ for estimating the to work with a different OPO. At
In outlining the limitations of the present, OPOs are reporting data to the
current re-certification process, number of potential donors in a
hospital, we considered proposing OPTN within 30 days of the end of the
Congress noted that outcome and month in which a death occurred, and
process performance measures should outcome measures based entirely on
we propose requiring that OPOs
be considered that would ‘‘more data derived from OPOs’ reviews of
continue to report their data within this
accurately reflect the relative capability hospital death records. GAO gave
time frame. We believe this provides
and performance of each organ serious consideration in its 1997 report
adequate time for OPOs to report data,
procurement organization.’’ We believe to the use of death record reviews
while ensuring that data will be
that basing multiple outcome measures performed by OPOs to determine the
available to us when needed for
on potential donor denominator data number of potential donors for OPO
certification purposes. (This proposal
reported to the OPTN, as we propose, certification. However, there are a
can be found in the proposed condition
would give us, each OPO, the organ number of disadvantages to basing
for reporting of data at § 486.328(b).)
donation and transplantation certification on death record review To ensure accuracy, OPOs would
community, and the public a clear data. In fact, the GAO report noted need to report the potential donor
picture of OPO capability and drawbacks to using OPO-conducted denominator data consistently, adhering
performance and eliminate possible death record reviews, including the cost strictly to the criteria in the proposed
inaccuracies and inconsistencies of the reviews and the challenge of definition for organ donor potential.
associated with current population- maintaining consistency in the reviews. Reporting the data ‘‘consistently’’ means
based standards. Maintaining consistency in that if the OPO determined at any time,
Using potential donor denominator performing death record reviews for from the referral of a patient by a
data reported to the OPTN would have certification purposes would be hospital through recovery and testing of
additional significant advantages. difficult, because we would have to the patient’s organs, that the patient met
Congress required the Secretary to ensure that all 59 OPOs performed the any of the rule-out criteria listed in the
propose standards based on ‘‘empirical reviews in the same manner. This definition, the patient would be
evidence, obtained through reasonable would require development of a eliminated as a potential donor and
efforts’’ of organ donor potential. Thus, standardized protocol for the reviews, as would not be reported to the OPTN
we believe that Congress expected that well as ongoing, nationwide training for under this regulation. If an OPO
the outcome measures data would be OPOs in hospital selection, sampling, determined through death record
verifiable and that the processes used to record review, and reporting. reviews or other means that the
obtain and verify the data would be Furthermore, it would be difficult for potential donor denominator data it
practical and sensible. many OPOs to complete death record reported to the OPTN was incorrect, the
The SRTR has developed a reviews for the final year of the re- OPO would be required to report the
methodology that is being used to certification cycle in time for us to use corrected data to the OPTN within 30
validate the data OPOs report to the the data for re-certification. (Note that days of the end of the month in which
OPTN. The methodology is based on while we propose requiring all OPOs to the mistake is identified. (This proposed
readily available data on hospital bed perform death record reviews as part of requirement can be found in the
size and other factors, as well as their QAPI programs (see proposed proposed condition for information
hospital death data obtained from the § 486.348), death record reviews management at § 486.328(b).)
National Center for Health Statistics. If performed by OPOs for their own However, while we propose basing
data reported by an OPO appear to be purposes would not require OPO outcome measures on the number
incorrect, the SRTR performs further standardization across OPOs because of potential donors as evidenced by
analysis, and the data is corrected if the reviews would be performed solely OPTN data, we are specifically
necessary. We are confident that the use to provide data for quality improvement requesting comments on the feasibility
of this methodology would ensure that for each individual OPO.) of basing OPO outcome measures on the
number of potential donors as together, they reflect the entire spectrum the national mean and, if so, the
determined by death record reviews. of the donation process for which those appropriate percentage threshold; (2)
OPOs are responsible. Furthermore, whether OPOs operating in non-
6. Outcome Performance Standards and
although it is true that organs recovered contiguous states or territories should be
Thresholds
by an OPO for transplantation required to meet more (or less) than 50
With the exception of OPOs operating sometimes are discarded (or used for percent of the national mean; and (3)
exclusively in non-contiguous U.S. research instead of transplantation) for whether OPOs located in the
States, territories, possessions, or reasons beyond the control of the OPO, continental U.S. should be required to
commonwealths, we propose an OPO OPOs are responsible for the majority of meet all 5 (instead of just 4) measures.
certification threshold of 75 percent of functions that determine whether an
the national mean for 4 out of 5 of the organ is transplanted (for example OPO Process Performance Measures
following outcome measures, averaged testing, recovery of the organ, Condition: Participation in Organ
over the 4 calendar years before the year packaging, and transport). Nevertheless, Procurement and Transplantation
of re-certification: (1) Donors as a since there is some disagreement in the Network (Proposed § 486.320)
percentage of the potential donor OPO community on this issue, we are
denominator; (2) number of kidneys Current OPO regulations at § 486.308
specifically requesting public comments
procured, as a percentage of the require OPOs to be members of and
on the need for each of the five
potential donor denominator; (3) abide by the rules of the OPTN, and we
measures.
number of kidneys transplanted, as a Under current regulations, OPOs propose to retain this requirement.
percentage of the potential donor report outcome performance data to us However, we propose eliminating the
denominator; (4) number of extra-renal only for pancreata procured for whole requirement for an OPO to become an
organs procured, as a percentage of the organ transplantation. However, OPTN member before becoming
potential donor denominator; and (5) legislation enacted on October 25, 2004 designated by us because the OPTN
number of extra-renal organs (Pub. L. 108–362) which amends section requires an OPO to furnish information
transplanted, as a percentage of the 371 of the PHS Act, requires that demonstrating designation by us to
potential donor denominator. pancreata recovered and used for islet become a member of the OPTN. (See 42
These five OPO performance factors cell transplantation or for research be CFR 121.3(b)(2).) Therefore, we propose
are the same as those used in the current counted for purposes of OPO that only after being designated would
outcome performance standards. certification and re-certification. an OPO be required to be a member of
However, the outcome performance Therefore, when compiling outcomes the OPTN. In addition, we propose to
measures we propose would be based performance measures data and eliminate the requirement that OPOs
on the organ donor potential in an utilizing the data for re-certification of have a written agreement with the
OPO’s service area, rather than the OPOs, we will include pancreata OPTN because a written agreement is
population in the service area. We are recovered and used for islet cell not part of the OPTN membership
proposing the same performance factors transplantation or for research under the process.
because they represent the totality of category of extra-renal organs, along Condition: Relationships With
what an OPO does—from identifying with pancreata recovered and used for Hospitals, Critical Access Hospitals, and
and managing potential donors through whole organ transplantation. Also, Tissue Banks (Proposed § 486.322)
ensuring delivery of healthy organs to because researchers and OPOs have
hospitals for transplantation. suggested that we encourage OPOs to [If you choose to comment on this
An OPO operating exclusively in non- recover other organs for research section, please include the caption
contiguous States, territories, purposes, we invite comment on ‘‘Relationships with hospitals’’ or
possessions, or commonwealths would whether all organs recovered for ‘‘Relationships with tissue banks’’ at the
be required to meet the following research should be included in the beginning of your comments as
outcome measures at 50 percent or more outcome measures. appropriate.]
of the national mean, averaged over the When the current outcome Good relationships between OPOs
4 calendar years before the year of re- performance standards were and organizations involved in the
certification: (1) Number of kidneys established, we deliberately set the donation process often result in more
procured, as a percentage of the threshold for re-certification at a point efficient operations, such as shared
potential donor denominator; and (2) we thought would prevent de- referral lines for hospitals to use when
number of kidneys transplanted, as a certification of good OPOs based on calling about deaths and collaboration
percentage of the potential donor what may have been imprecise between OPOs and tissue banks in
denominator. As in the current population-based performance training hospital designated requestors.
regulations, OPOs operating in non- standards. It would seem logical that Furthermore, collaboration and
contiguous areas would be required to along with adopting more precise cooperation between donation
meet measures only for kidneys outcome measures, we would raise the organizations promotes a positive public
procured and kidneys transplanted threshold for re-certification. However, opinion about donation.
because there are few extra-renal since measures based on a potential All six OPOs whose practices were
transplant programs located in non- donor denominator have never been studied for the Organ Donation
contiguous areas and because the used for OPO certification, we are Breakthrough Collaborative have strong
permissible cold ischemic time for somewhat reluctant to propose a change collaborative relationships with their
extra-renal organs is shorter than that in the threshold for re-certification that hospitals. Donor Alliance in Colorado
for kidneys, making shipment of extra- might result in the de-certification of has 6 full-time ‘‘donation consultants,’’
renal organs to the continental U.S. for many OPOs. Nevertheless, we are who are liaisons to the 100 hospitals in
transplantation problematic. specifically requesting public comment the OPO’s service area and provide
We believe all 5 proposed outcome on the following three issues: (1) professional education and feedback. In-
measures are critical for assessing Whether OPOs located in the house coordinators from LifeGift Organ
performance of OPOs located in the continental U.S. should be required to Donation Center in Houston meet
continental United States because, taken meet more (or less) than 75 percent of regularly with hospital medical staff to
review organ donation cases. The OPO’s service area.) Since it is donation with families of potential
University of Wisconsin OPO ‘‘views necessary for a hospital to have a donors. See § 482.45(a)(3).)
hospital staff as an extension of OPO ventilator to maintain a potential donor The OIG estimated that 70 percent of
staff, contributing to the achievement of and an operating room for recovery of hospitals had been offered designated
OPO goals.’’ Their OPO staff encourage organs, we believe a requirement for requestor training by their OPOs;
physicians, nurses, and pastoral care OPOs to have agreements with 95 however, staff in only 44 percent of
staff to participate in the donation percent of hospitals and critical access hospitals had been trained. The OIG
process and provide support and hospitals with a ventilator and an suggested this could be due to ‘‘a
guidance. operating room would capture a number of practices that indicate OPO
Collaboration between OPOs and ‘‘substantial majority’’ of hospitals with resistance to training and using hospital
hospitals is absolutely critical to the facilities for organ donation. staff as designated requestors.’’ They
donation process. Good relationships Our OPO Coordinators have found noted that some OPOs make it difficult
encourage cooperation from hospital that most OPOs ask their hospitals to for hospitals staffs to attend training (for
staffs in making referrals of potential sign a ‘‘generic’’ agreement that does not example, holding training sessions
donors timely, supporting OPOs in address each entity’s role in the several hundred miles away from
discussing donation with families (or donation process and does not define hospitals), and other OPOs establish
acting as designated requestors), and key terms, such as ‘‘imminent death’’ programs that lack the flexibility to
providing support services for and ‘‘timely referral.’’ This lack of respond to the needs of various types of
management of potential donors. We specificity can lead to problems; for hospitals and individuals.
expect that the requirements we propose example, disagreement between an OPO Although CMS intended the
will increase communication and and hospital about their respective roles designated requestor requirement in the
cooperation between OPOs and the in discussing donation with families, hospital CoP to lead to more
hospitals in their service areas. differing viewpoints of OPO staff and collaboration between OPOs and
The current regulations at § 486.306(g) hospital physicians regarding what hospitals and increased hospital
require OPOs to have a working constitutes ‘‘imminent death,’’ or
involvement in the donation process,
relationship with at least 75 percent of the OIG commented that the
disagreements between an OPO and
the Medicare and Medicaid requirement may have had the opposite
hospital about the appropriate timing of
participating hospitals in their service effect. That is, since OPOs are reluctant
referrals to the OPO. However, the
areas that have an operating room and to train hospital staffs and to involve
Coordinators have observed that where
the equipment and personnel for them in the donation process, some
OPOs network with their hospitals to
retrieving organs. Regulations at hospitals are allowing OPOs to take over
clearly define roles and responsibilities
§ 486.304(b)(8) require OPOs to have a the entire donation process.
for the donation process, referral rates Nevertheless, in some OPO service
working relationship with any hospital
are higher. areas, the OPO handles most or all
in the service area, including a
transplant hospital that requests a Therefore, to avoid problems, promote requests for donation, and consent rates
working relationship. Furthermore, the collaboration, and assure that OPOs’ are good. In other areas, hospitals
hospital and critical access hospital agreements with their hospitals support cannot spare staff to attend designated
CoPs for organ, tissue, and eye the overall goal of maximizing organ requestor training, and the hospital and
procurement require all Medicare and donation and transplantation, we critical access hospital CoPs makes it
Medicaid participating hospitals and propose requiring that OPOs’ clear that the hospital, not the OPO, has
critical access hospitals to have and agreements with hospitals and critical the right to decide whether an OPO
implement an agreement with an OPO access hospitals must describe the representative or a hospital designated
designated under part 486 that includes responsibilities of both the OPO and the requestor will offer the option of
a protocol for referral of all deaths and hospital in regard to the hospital donation. Based on these facts, we do
imminent deaths. (See §§ 482.45 and requirements at §§ 482.45 or 485.643, as not believe it would be advisable to
485.643.) appropriate, (for example, how referrals require every OPO to provide
We considered proposing a rule that will be made and how collaboration in designated requestor training in every
would require an OPO to have an reviewing death records will occur) and hospital and critical access hospital in
agreement with every hospital and specify the meaning of the terms, its service area. Instead, we propose
critical access hospital in its service area ‘‘timely referral’’ and ‘‘imminent death.’’ requiring OPOs to offer designated
(unless a hospital had a waiver to work One of our proposals for OPOs’ requestor training on at least an annual
with a different OPO) to ensure that relationships with their hospitals is basis for hospital and critical access
OPOs do not overlook a single potential based on observations made by the hospital staffs. We propose that training
donor. However, the PHS Act requires Office of the Inspector General (OIG) in be offered at least annually because
only that an OPO have agreements with its August 2000 report on the hospital most hospital staff do not discuss
a ‘‘substantial majority’’ of hospitals in CoP. The OIG noted that although donation with families frequently
its service area that have facilities for research shows that collaboration enough to maintain their proficiency
organ donation. between OPOs and hospitals in unless they receive periodic training.
Therefore, we propose maximizing approaching families about organ We urge OPOs to encourage
the number of hospitals with which donation yields the highest consent designated requestor training so that
OPOs have agreements (consistent with rates, the OIG found that 23 out of 61 hospital staff can support and
the PHS Act) by requiring OPOs to have OPOs had not provided any training to collaborate with OPO staff in the
agreements with 95 percent of the hospital staffs. Only 22 OPOs had donation process. We applaud the
hospitals and critical access hospitals in trained designated requestors in more efforts of OPOs like LifeLine of Ohio
their service areas that have both a than 10 percent of the hospitals in their that actively promote designated
ventilator and an operating room. (Note: service areas. (A ‘‘designated requestor’’ requestor training in hospitals. In its
If a hospital received a waiver from us under the hospital CoP is an individual ‘‘Quest for Excellence’’ in educating
to work with another OPO, the hospital who has been trained in a course offered hospitals, LifeLine made it possible for
would not be counted as part of the or approved by the OPO to discuss staff in those hospitals to earn free
continuing education credits by in a donor for whom consent has ‘‘Administration and governing body’’ at
completing designated requestor already been obtained may reflect badly the beginning of your comments.]
training, either in the hospital or via the on the OPO, rather than the tissue bank. In the current regulations,
Internet. In the University of Wisconsin Clearly, difficult relationships requirements for OPO boards are found
OPO service area, hospital staff are the between OPOs and the tissue banks in at § 486.306, which lists qualifications
primary requestors. OPO staff conducts their service areas waste valuable time to be designated by us as an OPO. We
a designated requestor training program and energy and distract OPOs from their propose creating a separate section for
and ongoing training and case reviews mission of maximizing organ donation. administration and governing body,
at hospitals to educate hospital staff Therefore, based on the Secretary’s which would contain the proposed
about all aspects of organ donation, authority under section 1102 of the Act requirements for membership
including case management. to establish requirements necessary for composition and bylaws of OPO boards,
Before the CoP, hospitals called tissue the efficient administration of the as well as requirements for the
banks about potential tissue donors and Medicare program, as well as the PHS governing body that would have legal
called OPOs about potential organ Act requirement at section 371(b)(3)(I) authority and responsibility for the
donors. However, the hospital CoP at for OPOs to ‘‘cooperate’’ with tissue management and provision of OPO
§ 482.45 and critical access hospital CoP banks to ensure all usable tissues are services.
at § 485.643 require hospitals and obtained, we are proposing Section 371(b)(1)(G) of the PHS Act
critical access hospitals to refer all requirements to ensure that OPOs (42 U.S.C. 273(b)(1)(G)) stipulates that a
deaths and imminent deaths (rather maintain collaborative relationships qualified OPO must have a board of
than just potential organ donors) to an with the tissue banks in their service directors or an advisory board that is
OPO. The hospital and critical access areas. We believe the requirements we composed of:
hospital CoPs state that in the absence propose would serve to promote • Members who represent hospital
of alternative arrangements between a cooperation on the part of OPOs. administrators, intensive care or
hospital and a tissue bank, the OPO will We propose to strengthen the current emergency room personnel, tissue
determine suitability for tissue requirement for OPOs to cooperate with banks, and voluntary health associations
donation. However, after the hospital tissue banks in the retrieval, processing, in its service area;
CoP went into effect in August 1998, preservation, storage, and distribution of • Members who represent the public
very few hospitals were willing to have tissues, as may be appropriate, to ensure residing in such area,
‘‘alternative arrangements’’ that would • A physician with knowledge,
that all usable tissues are obtained from
have required them to call tissues banks experience, or skill in the field of
potential donors. We propose requiring
about potential tissue donors in histocompatibility;
OPOs to have arrangements with tissue • A physician with knowledge or
addition to calling an OPO about every
banks that have agreements with skill in the field of neurology; and
death. Thus, in most areas of the
hospitals and critical access hospitals • A surgeon from each transplant
country, OPOs became the
with which the OPO has agreements to center in the OPO’s service area with
‘‘gatekeepers’’ for information about
cooperate in the following activities, as which the OPO has arrangements to
potential tissue donors. Since many
may be appropriate, to assure that all coordinate its activities. (The surgeon
OPOs are in the tissue banking business,
usable tissues are obtained from must have practicing privileges in the
the OPOs’ gatekeeper position created
potential donors: represented transplant center and
some tension between a few OPOs and
the independent tissue banks in their (1) Screening and referral of potential perform organ transplant surgery).
service areas. tissue donors; In addition, the PHS Act states the
We have received complaints both (2) Obtaining informed consent from board has the authority to recommend
from tissue banks and OPOs. Tissue families of potential tissue donors in the policies for the procurement of organs
banks have charged that OPOs fail to absence of a donor document; and and other functions (which are
notify them about potential tissue (3) The retrieval, processing, described below) and has no authority
donors in a timely manner, charge preservation, storage, and distribution of over any other activity of the OPO.
unreasonable referral fees for notifying tissues. The current regulations at § 486.306(f)
them of potential donors, refuse to allow An OPO would not be required to require an OPO to have a board of
tissue banks to participate in designated have an arrangement with a tissue bank directors or an advisory board. An OPO
requestor training sessions OPOs unwilling to have an arrangement with may have more than one board, but at
provide to hospitals, or refuse to use the the OPO. In such a situation, we would least one board must be responsible for
tissue banks’ screening and notification not consider the OPO to be out of recommending policies relating to the
protocols when referring donors. compliance with the requirement. donation, procurement, and distribution
For their part, OPOs have complained It should be noted here that the goal of organs and include the specific
that some tissue banks have paid no of the Secretary’s Donation Initiative is membership composition required by
referral fees since the hospital CoP went to increase all types of donation, the PHS Act. (See section 371(b)(1)(H)
into effect in August 1998. (We require including tissue, marrow, and blood (42 U.S.C 273(b)(1)(H).)
OPOs to charge tissue banks for their donation. Therefore, although the We are proposing a similar
costs in making referrals so that the purpose of this proposed rule is to requirement, in that an OPO may have
costs are not passed on to the Medicare increase organ donation, the Secretary as many individual boards as it chooses,
program. (See Medicare Provider has an interest in ensuring that OPOs but one of its boards must have the
Reimbursement Manual, section act responsibly and collaboratively to specific membership composition
2773.1)) In addition, some OPOs have further tissue donation in the United prescribed by the PHS Act and must
charged that tissue banks do not States. operate under restraints similar to those
respond timely to the referrals they prescribed by the PHS Act for that
receive, resulting in the loss of viable Condition: Administration and board. That is, the board would be
tissue. Since donor families and the Governing Body (§ 486.324) limited to recommending policies
public often regard all donation as organ [If you choose to comment on this relating to the donation, procurement,
donation, that loss of donation potential section, please include the caption and distribution of organs, would serve
only in an advisory capacity, and could agreements to identify potential organ Breakthrough Collaborative) has
not also serve as the OPO’s board of donors with a substantial majority of balanced the representation on its board
directors. For purposes of discussion in hospitals in its service area that have by adding members to its board who
this preamble, we refer to this board as facilities for organ donation; (2) represent other hospitals and
an advisory board. To ensure that the systematic efforts, including community interests. Donor alliance,
board’s members remain in an advisory professional education, to acquire all another OPO studied by the
capacity as stipulated by the PHS Act, usable organs from potential donors; (3) Collaborative, has a 25-member
we propose that the board’s members arrangements for the acquisition and community-based board that has
would be prohibited from serving on preservation of donated organs and ‘‘allowed considerable latitude for
any other OPO board. We also would provision of quality standards for the innovation and risk-taking.’’
require OPOs to have bylaws for each of acquisition of organs that are consistent By incorporating this language into
its boards to address potential conflicts with the standards adopted by the our proposed regulations for OPOs, we
of interest, length of terms, and criteria OPTN, including arranging for testing are reminding OPOs and their boards
for selection and removal of members. with respect to preventing the that under the PHS Act, the OPO board
Note that there appears to be a cross- acquisition of organs that are infected whose membership composition is
reference problem in the PHS Act with the etiologic agent for acquired outlined in the PHS Act has specific
related to the recommendations of the immune deficiency syndrome; limits placed on its authority.
advisory board. The statute provides appropriate tissue typing of organs; a Note that our proposed language
that the advisory board ‘‘has the system for allocation of organs among differs from that of the PHS Act in some
authority to recommend policies for the transplant patients according to respects. Instead of ‘‘a system for
procurement of organs and other established medical criteria; allocating organs according to
functions described in (2). (See 42 U.S.C transportation of organs to transplant established medical criteria’’ we
273(b)(1)(H)(ii).) Currently, section hospitals; coordination of activities with propose referencing ‘‘a system for
371(b)(2) is directed to the Secretary and transplant hospitals in the OPO’s allocating organs according to the rules
concerns rulemaking. It does not speak service area; participation in the OPTN; and requirements of the OPTN,’’
to policies where an advisory board’s arrangements to cooperate with tissue because the OPTN establishes the
recommendations would be relevant for banks for the retrieval, processing, medical criteria used to allocate organs
an OPO. We believe it is likely that preservation, storage, and distribution of among transplant patients. (The term
Congress intended that the OPO obtain tissues as may be appropriate to ensure ‘‘rules and requirements of the OPTN’’
the recommendations of the advisory that all usable tissues are obtained from means those rules and requirements
board on the functions that an OPO is potential donors; annual evaluation of approved as enforceable by the
required to perform and that are listed Secretary.)
the effectiveness of the OPO in
in section 273(b)(3). We are proposing Both the PHS Act and the existing
acquiring organs; and assistance to
that the advisory board make regulations require an OPO to have a
hospitals in establishing and tissue bank representative on its board.
recommendations to the OPOs on the implementing protocols for making
subjects discussed in section 273(b)(3) We propose requiring an OPO to have
routine inquiries about organ donations on its advisory board a tissue bank
and that are specifically listed in by potential donors. The PHS Act states
proposed § 486.324(b) through (11). representative from a facility not
that the OPO board ‘‘has no authority affiliated with the OPO, unless the only
Even if there were not a cross-reference over any other activity of the
problem, we would propose that the tissue bank in the service area is
organization.’’ (See section affiliated with the OPO. (In other words,
advisory board make recommendations
371(b)(1)(H)(iii) of the PHS Act (42 if the OPO operates a tissue bank, the
to the OPO on the topics identified in
U.S.C. 273(b)(1)(H)(iii).) OPO must include an independent
our proposed rules based on our
authority at 42 U.S.C. 1102. The It has come to our attention that some tissue bank on the board that represents
expertise of the board would provide a OPO boards with the membership all independent tissue banks in the
useful perspective on those issues, and composition stipulated by the PHS Act OPO’s service area, unless there are no
the advisory board’s recommendations may do more than recommend policies. independent tissue banks in the OPO’s
would likely lead to more efficient and This is a matter of concern because service area.) These requirements
effective actions by the OPO in some OPOs have told us that their presume that tissue bank representatives
procuring organs, as well as better boards prevent them from taking steps with these qualifications exist in an
coordination with various business to adopt best practices because of the OPO’s service area and would be willing
partners. costs involved (for example, by refusing to serve on the OPO’s advisory board. If
We propose including in the to approve the hiring of additional staff not, the OPO would not be considered
condition for administration and or implementation of protocols to out of compliance with this
governing body, certain language from provide better management of potential requirement.
the PHS Act that specifies the types of donors). Board members may be Because of the ‘‘gatekeeper’’ role of
policies this advisory board can motivated by a desire to keep standard OPOs in regard to potential tissue
recommend. We believe that it is worth organ acquisition fees low for the donors, we believe it is important for
restating these specific provisions, both transplant hospitals in their OPO’s OPO boards to include representatives
because the philosophy behind them is service area; however, the result may be from tissue banks that are not affiliated
important and because we do not that organ donation rates remain low as with the OPO (unless, of course, the
believe all OPOs and OPO board well. We would note that some OPOs OPO has the only tissue bank in the
members are aware of them. have taken steps to address what they service area) to ensure that tissue banks
The single OPO advisory board whose regard as the conflict of interest created have some voice in the OPO policies
membership composition is mandated by having a board heavily weighted that affect them and to encourage OPOs
by the Act has the authority to with representatives of transplant and tissue banks to work together on
recommend policies for the centers. For example, New England issues that affect both organizations.
procurement of organs and other Organ Bank (one of the high-performing Although the PHS Act specifies that
functions including: (1) Effective OPOs studied in the Organ Donation hospital administrators must be
represented on an OPO’s board of represent the hospital or hospital system maximize recovery of healthy organs for
directors or advisory board, it does not adequately. transplantation. Furthermore, both
specify whether donor or transplant When selecting transplant surgeons research studies (which are cited
hospital administrators should be for their advisory boards, OPOs should throughout our discussion of proposed
represented. Since transplant hospitals strive for representation of all organ § 486.326) and the experiences of our
are already well represented by the types. That is, if an OPO’s service area OPO Coordinators provide evidence that
many transplant surgeons who serve on includes heart, liver, lung, pancreas, having a sufficient number of trained
OPO boards, we strongly urge (but and kidney transplant programs, the and qualified staff is positively
would not require) OPOs to include OPO should include a surgeon who associated with good outcomes, such as
administrators from donor hospitals to performs each type of transplant. increases in organ donation. We also
provide input and foster collaboration We are proposing to require that note that one of the best practices
between OPOs and their donor OPOs have a governing body (for identified by the Organ Donation
hospitals. example, a board of directors) that has Breakthrough Collaborative is to ‘‘strive
We have received suggestions that we full legal authority and responsibility to recruit and retain highly motivated
require OPOs to include representatives for the management and provision of all and skilled staff.’’
from research facilities, donor family services. We believe it is important for Thus, we are proposing human
members, transplant recipients, efficient operation of an OPO for resources requirements that we believe
coroners or medical examiners, social authority to reside in a single body. The are essential to the functioning of all
workers, and chaplains on their governing body would be responsible OPOs. We propose that an OPO would
advisory boards. Although these are for developing and overseeing be required to have a sufficient number
worthy suggestions, we are reluctant to implementation of policies and of qualified staff to ensure that all
require OPO advisory boards to procedures necessary for effective usable organs are recovered and to
accommodate all these interests, lest administration of the OPO, including provide all required services to the
they become too large to operate fiscal operations, a QAPI program, and families of potential donors, hospitals,
effectively. Additionally, many OPOs services furnished under contract or tissue banks, and individuals and
already include some of these arrangement, including agreements for facilities that use organs for research.
these services. We would require an OPOs would be required to ensure
individuals on their boards to fulfill the
OPO to have a procedure to address that all individuals who provide or
requirement for members representing
potential conflicts of interest for the supervise services, including services
the public. Therefore, we are requesting
governing body. In addition, we would provided under contract or arrangement,
comments on the advisability of
require the governing body to appoint are qualified to perform these duties.
requiring OPO boards to have those In addition, we would require every
representatives. an individual to be responsible for day-
to-day operation of the OPO. We are OPO to develop and implement a
Note that, for clarification purposes, written policy to address potential
requesting public comment regarding
we are proposing to change the current conflicts of interest for the OPO’s
the proposed requirement for a
requirement for an OPO to have a director, medical director, senior
governing body, specifically, whether it
transplant surgeon from each transplant management, and procurement
would be appropriate for the legal
center on its board to a requirement for coordinators. In 2002, we cited a Florida
authority and responsibility for the
an OPO to have a transplant surgeon OPO whose procurement director
management and provision of all OPO
from each transplant hospital on its owned a company that purchased
services to lie with an individual, rather
advisory board. Although ‘‘transplant organs from the OPO and sold them for
than a governing body.
hospital’’ and ‘‘transplant center’’ are We believe the requirements we research—a serious conflict of interest
often used interchangeably, the term propose would provide flexibility so that led to the dismissal of OPO
‘‘transplant center’’ sometimes is used that each OPO would be free to choose officials. We believe an OPO’s conflict-
to refer to an individual transplant the most efficient and effective form of of-interest policy should clearly
program (such as a heart transplant administration and governance to suit delineate and prohibit those outside
program or liver transplant program) its own needs and to fulfill its mission activities or affiliations that have the
within a hospital that performs of maximizing organ donation. potential to impact an employee’s
transplants. Since some OPOs have ability to make impartial decisions that
more than a dozen transplant hospitals Condition: Human Resources (Proposed are in the best interests of both the OPO
in their service areas, a requirement to § 486.326) itself and the organ procurement and
have a transplant surgeon from each [If you choose to comment on this transplantation system in the United
program within each hospital would section, please include the caption States.
lead to OPO advisory boards with an ‘‘Human resources’’ at the beginning of Although the Medicare hospital
overwhelming number of members. your comments.] regulations require hospitals to review
Therefore, we believe it is advisable to The current regulations at § 486.306(e) credentials and grant clinical privileges
change the language to clarify that even require an OPO to have ‘‘a director and to medical staff, it is difficult, if not
if a hospital has multiple transplant such other staff, including an organ impossible, for a donor hospital to
programs, the OPO need have only one donation coordinator and an organ credential and grant privileges to
transplant surgeon per transplant procurement specialist, necessary to recovery surgeons and other members of
hospital or hospital system. obtain organs effectively from donors in recovery teams who are not members of
In addition, we propose requiring that its service area.’’ There are no additional the hospital’s medical staff. Recovery
the transplant surgeon who serves on human resources requirements in the surgeons and other recovery team
the OPO board must have practicing current regulations. members may recover organs in a
privileges and perform transplants in We do not believe this single particular donor hospital no more than
the hospital he or she represents. This requirement is adequate to ensure that once in a period of several years. Thus,
requirement would ensure the surgeon each OPO has a sufficient number of their work is too limited to undergo
has a thorough knowledge of the needs staff members with the proper skills to effective review by the donor hospital
of the transplant hospital and can provide necessary services and to for the granting of clinical privileges.
However, it is imperative that someone United Network for Organ Sharing However, we can provide guidance to
ensure recovery personnel are qualified (UNOS) staff members.) (Note that OPOs so that they can determine if the
to recover organs in a manner that UNOS is the organization under number of staff they have would be
preserves their viability for contract with the Health Resources and ‘‘sufficient’’ under the proposed
transplantation. Services Administration to operate the regulation. The determination is based
Therefore, we propose requiring OPOs OPTN.) primarily on outcomes, not just the
to maintain credentialing records for The report on LifeGift’s 12-year ultimate outcome—procuring a healthy
physicians and other practitioners who experience noted that ‘‘adequate, even organ for transplantation—but the
routinely recover organs in hospitals ‘deep’ staffing levels allowed the OPO to intermediate steps that lead to the
under contract or arrangement with the respond in person within one hour of procurement (such as assessing the
OPO (for example, transplant surgeons referral on every potential organ donor potential donor and obtaining consent),
from local transplant hospitals who case.’’ We do not propose mandating a as well as those critical activities that
frequently recover organs in the OPO’s 1-hour time frame because geographical support and surround the actual
donor hospitals). In addition, we and other differences in OPO service donation process (such as hospital
propose requiring OPOs to ensure that areas could make such a short time development and death record reviews).
all physicians and other practitioners frame impossible to meet. Furthermore, An OPO should analyze the flow of
who recover organs in hospitals with some hospitals contact their OPOs very the donation process in each of its
which the OPO has agreements are early in the donation process, which hospitals, and determine whether the
qualified and trained. Note that we are means it may not be necessary for OPO flow is impeded at any point by a lack
not proposing a requirement for an OPO staff to arrive at the hospital within 1 of staff. Does the OPO have enough staff
to maintain credentialing records for hour. Clearly the ideal time frame is one available at all times to: Assess potential
physicians and other practitioners if in which the OPO arrives at the hospital donors promptly; spend as much time
they do not routinely recover organs early enough to ensure that all steps in as necessary with the family to answer
under contract or arrangement with the the donation process can take place, and questions and provide support and
OPO (for example a transplant surgeon the desired outcome is the recovery of counseling; manage the potential donor
from a hospital outside the OPO’s healthy organs. optimally; maximize the number of
service area). In those circumstances, organs placed for transplantation; and
Therefore, we propose requiring the
the OPO would be required only to recover (or arrange for the recovery of)
OPO to provide sufficient coverage,
verify that the transplant surgeon was organs as quickly as possible?
either by its own staff or under contract An OPO should scrutinize its QAPI
qualified and trained. This could be
or arrangement, to screen hospital program and determine whether
accomplished by, for example,
referral calls for organ donor potential additional staff would enable the OPO
contacting the transplant hospital to
and evaluate potential donors for to broaden the scope of its QAPI
confirm that the surgeon who will be
medical suitability for organ donation in program and lead to improved
recovering an organ at one of the OPO’s
a timely manner. This means that once performance. Does the OPO have
hospitals is credentialed and has
privileges at the transplant hospital. an OPO receives timely notification sufficient staff to monitor and evaluate
Studies provide empirical evidence from a hospital about a patient who all donation services; recommend steps
that sufficient staffing serves to appears likely to be medically suitable to improve performance; track
maximize organ donation. For example, for organ donation, the OPO must performance over time; and perform
in a report on 12 years of experience at perform an assessment of the patient’s death record reviews at Medicare and
LifeGift Organ Donation Center in medical suitability for organ donation Medicaid hospitals that have a level I or
Texas, the report’s authors commented early enough in the donation process so level II trauma center or 150 or more
that LifeGift’s staff resources were that there is sufficient time to discuss beds (with the exception of psychiatric
‘‘critical to its ability to sustain and donation with the family of the and rehabilitation hospitals)?
increase donation.’’ They noted that potential donor, implement An OPO also should look closely at
LifeGift in the 7-year period preceding management protocols for the potential hospital development staffing because
publication of the report had an 80 donor, place the organs for effective hospital development creates a
percent growth in staff and a 61 percent transplantation, and arrange for culture that supports and promotes
increase in organ donors. (T. Shafer, C recovery and transportation of the donation. Does the OPO have sufficient
Van Buren, C Andrews; Program organs while they are still viable. staff to make its presence felt in
Development and Routine Notification In addition, we propose requiring an hospitals (particularly those hospitals
in a Large Independent OPO: A 12-year OPO to have a sufficient number of with high donation potential) by:
Review, Journal of Transplant qualified staff to provide information Developing a relationship with
Coordination, Vol. 9, No. 1, March, and support to potential organ donor emergency department and intensive
1999.) families; request consent for donation; care unit staff; providing ongoing
A recent report on OPO best practices ensure optimal maintenance of donors, education for hospital staff; meeting
listed ‘‘timely, on-site response to efficient placement of organs, and with hospital leaders and key
potential donor referrals’’ as a key adequate oversight of organ recovery; physicians to gain their support for
attribute of a successful OPO. and conduct QAPI activities, such as organ donation; providing donation data
(Preliminary results of a best practices death record reviews and hospital and encouraging hospitals to use the
study presented at tri-annual meeting of development. We are not proposing data in quality improvement activities?
the South-Eastern Organ Procurement specific staffing levels because we As stated earlier, we do not propose
Foundation on September 14, 2000 by believe each OPO must determine the to establish specific staffing levels
R. Randal Bollinger, MD, Ph.D. Chief of amount of staff it needs to ensure that because OPOs must have the flexibility
the Division of General Surgery, Duke families of potential donors are treated to determine their own staffing needs.
University Medical Center. In addition with sensitivity and respect and that the However, OPOs rightfully will be
to Dr. Bollinger, other study authors maximum number of viable organs are concerned about how such an imprecise
include Dennis Heinrichs, MBA, procured and provided to hospitals for requirement would be enforced.
President, LifeLink Foundation; and transplantation. Certainly we understand that for reasons
beyond their control, OPOs (like all to ensure that all usable organs are information to inform the development
other businesses) sometimes will not recovered in a manner that, to the extent of training, tailor their training to the
have enough staff. We would not cite an possible, preserves them for needs of their staffs, and identify
OPO for having insufficient staff if the transplantation. This proposal is based individual staff who require additional
insufficiency is temporary or occasional on our OPO Coordinators’ knowledge of training.
or if the OPO clearly is doing its best to situations in which organs were not We believe in-depth training for
keep staffing at an optimal level. The recovered from medically suitable procurement coordinators is particularly
requirement is intended to give potential because local surgeons or critical because procurement
surveyors the option of citing an OPO other recovery personnel were not coordinators serve on the OPO front
when there is a pattern of chronic available. Some OPOs prevent these lines. They provide counseling to
understaffing in critical areas, and the situations by hiring their own recovery grieving families, explain donation
OPO has not taken the appropriate steps personnel. For example, one of the high- options, make the request for donation,
to improve the situation (for example, if performing OPOs studied in the Organ oversee recovery of organs, and package
the board of directors consistently has Donation Breakthrough Collaborative, organs for transport to transplant
refused to approve funds for additional Donor Alliance, has circumvented this hospitals. One of a procurement
staff needed to improve the OPO’s problem by hiring ‘‘organ recovery coordinator’s most critical functions is
performance). specialists’’ with extensive training and management of potential donors to
The OPTN/UNOS Council for Organ experience in organ recovery. maintain the viability of their organs,
Availability Requestor Project studied The current OPO regulations have no which is a highly complex and
organ donation requestors who have the requirements for an OPO’s management demanding task. Nevertheless, some
greatest success in getting families to of its human resources. We believe that procurement coordinators have told us
consent to organ donation. Results of prudent management of human their OPOs do not provide sufficient
the study suggest that the experience of resources, including provision of training and supervision for new
procurement coordinators is positively sufficient education, training, procurement coordinators, even though
associated with increased consent rates; supervision and evaluation, is a inexperienced coordinators run the risk
the average ‘‘expert requestor’’ has 4 fundamental necessity if OPOs are to of making errors that can lead to denial
years of experience. The LifeGift report have expert, highly qualified staff who of consent or the loss of a donor.
notes that adequate staffing results in a can maximize organ donation. Ongoing Therefore, in an effort to decrease
staff that is not ‘‘spread too thin.’’ The staff training is a necessity at all OPOs errors and provide support to the
report also notes that adequate staffing in order to maintain staff skill sets and inexperienced coordinator, we are
allows, when appropriate, assigning two keep up with rapid advances in requesting comments on the advisability
coordinators to one donor case, which procurement and transplantation. of including a requirement in the final
may improve organ yield by allowing However, we have found that a few rule for supervision of an inexperienced
one coordinator to focus on donor OPOs do not provide these services for procurement coordinator by an
management while another focuses on their staffs, which leads to confusion experienced procurement coordinator,
organ placement. We believe that about roles and responsibilities, sub- director of procurement, medical
adequate staffing by OPOs avoids staff optimal staff functioning, and resultant director, or other experienced
burn out and frequent turnover of organ poor OPO performance. Conversely, our individual during the consent process
procurement coordinators, which is a OPO Coordinators have noted lower and during management of all donor
significant problem for many OPOs. staff turnover among OPOs that provide cases. In addition, we are requesting
A recent study published in the education and training and clearly comments on whether experience
Journal of the American Medical define their staffs’ roles and should be defined by length of service
Association on factors that influence responsibilities. or number of donation cases, what
family consent noted, ‘‘Our data Therefore, we propose requiring OPOs experience thresholds would be
strongly indicated that involvement of to provide their staffs with the appropriate, and how long an
the family with a professional from the education, training, and supervision inexperienced procurement coordinator
OPO is critical. The time spent with the necessary to furnish required services. would need supervision.
OPO coordinator was a strong factor Training must include, but is not We acknowledge that it can be
associated with the decision to donate.’’ limited to, performance expectations for difficult for OPOs to hire and retain staff
(Siminoff, L, Gordon, N, Hewlett, J, staff, applicable organizational policies with the necessary qualifications,
Arnold, R. Factors Influencing Families’ and procedures, and QAPI activities. In experience, and dedication to fill
Consent for Donation of Solid Organs addition, OPOs must evaluate the critical staff positions, particularly
for Transplantation. Journal of the performance of their staff and provide procurement coordinator positions, and
American Medical Association. 2001; training, as needed, to improve to provide their staffs with education
286:71–77.) It is clear that adequate individual and overall staff performance and training. Many OPOs find high staff
staffing can ensure that procurement and effectiveness. For example, staff turnover to be a significant barrier to
coordinators have ample time to spend who make donation requests can be increasing organ donation in their
with donor families. (Note that in citing evaluated by their consent rates; staff service areas. Nevertheless, many OPOs
this study, we are not suggesting that who clinically manage donors can be are able to recruit and retain qualified
hospital designated requestors should evaluated by how many organs are staff by providing training,
not be involved in the donation process. recovered and transplanted from donors opportunities for growth, and a
Studies show that involvement of and whether immediate organ function supportive atmosphere that encourages
hospital staff with the OPO in occurs in the recipient; and hospital independence and innovation. It is clear
requesting consent leads to the highest development staff can be evaluated by that the six OPOs whose practices were
consent rates.) the percentage of cases in which timely studied as part of HRSA’s Breakthrough
Finally, we propose requiring an OPO donation notifications are made and Collaborative would all agree that
to provide a sufficient number of how often donation requests are professional, committed, and
recovery personnel, either from its own conducted collaboratively between OPO experienced staff have formed the basis
staff or under contract or arrangement, and hospital. An OPO can utilize this for their success. One of the OPOs, New
England Organ Bank, emphasizes that another example, Mid-America’s two whether the OPO has met the
its devoted staff and low staff turnover operating rooms are used to give their performance requirements. We propose
are contributing factors to its high clinical staff an opportunity to learn broadening this requirement to require
performance. new skills and develop professionally. OPOs to provide individually-
The Collaborative’s Best Practices We urge all OPOs to read the report identifiable, hospital-specific organ
Final Report identified five strategies of the Collaborative, titled, ‘‘The Organ donation and transplantation data to the
OPOs can use to recruit and retain Donation Breakthrough Collaborative: OPTN and the Scientific Registry of
skilled and motivated staff. Best Practices Final Report,’’ which is Transplant Recipients (SRTR), as
The first strategy is to use various available on the Department’s Web site directed by the Secretary. (Note that at
practices to identify and recruit staff. at http://www.organdonor.gov. present the SRTR does not collect data;
For example, according to the study Voluntary OPTN bylaws call for OPOs its current mandate is to analyze data
report, LifeLink of Florida uses an to have a medical director who is a collected by the OPTN.) We also
extensive ‘‘reality’’ interview process in licensed physician and is responsible propose requiring OPOs to provide
which candidates meet with staff and for the medical and clinical activities of hospital-specific organ donation data to
participate in actual organ referral and the OPO. Although current regulations transplant hospitals, annually. Finally,
donation events. This process enables do not require OPOs to have a medical we propose requiring OPOs to report
LifeLink to hire staff who are director, most OPOs employ a medical individually-identifiable, hospital-
‘‘aggressive, collaborative, assertive, and director as part of their management specific organ donation and
able to work under stressful staff and recognize the value and transplantation data and other
conditions.’’ expertise this position brings to their information to the Department, as
The second strategy is to offer OPO programs. Our OPO Coordinators requested by the Secretary.
adequate orientation and training. One have found that most high-performing Data could include, but would not be
of the six high-performing OPOs, New OPOs have active, involved medical limited to, (1) The number of hospital
England Organ Bank, puts newly-hired directors. Therefore, we propose deaths; (2) results of death record
staff through a formal training program requiring an OPO to have a medical reviews; (3) number and timeliness of
‘‘tailored to their specialized function.’’ director who would be responsible for referral calls from hospitals; (4)
The third strategy is to create a implementation of protocols for donor potential donor denominator (as defined
culture of collaboration and autonomy. evaluation and management and organ in § 486.302); (5) data related to non-
Every high-performing OPO studied placement and recovery. recovery of organs, (6) data about
pointed to strong collaborative The medical director would be consents for donation; (7) number of
relationships as a factor that contributes responsible for oversight of the clinical donors; (8) number of organs recovered
to their success. These OPOs have management of donation cases, (by type of organ); and (9) number of
forged successful relationships both including providing assistance in the organs transplanted (by type of organ).
within their own staffs and with outside medical management of a donor case We would note that OPOs are
organizations and other parties in the when the surgeon on call is unavailable. specifically exempted from regulatory
donation process, such as tissue banks, We would expect that in meeting these requirements for the privacy of
hospital administrators, physicians, and requirements, OPOs would have individually identifiable health care
nurses. medical directors who oversee clinical information under the Health Insurance
Perhaps the best example of donation processes, facilitate best Portability and Accountability Act.
collaboration is the in-house practices, and provide guidance for OPO Regulations at 45 CFR 164.512(h) state,
coordinator (IHC) program developed by staff, both clinical and non-clinical, ‘‘A covered entity may use or disclose
LifeGift Organ Donation Center in about all clinical donation issues. protected health care information to
Houston, which places two full-time We believe the human resources organ procurement organizations or
nurses in all Level I trauma centers. requirements we propose would ensure other entities engaged in the
According to the study, the OPO staff efficient and effective operation of procurement, banking, or
are ‘‘fully integrated into hospital OPOs, which is in the best interests of transplantation of cadaveric organs,
operations,’’ which promotes ‘‘strong, the organ donation and transplantation eyes, or tissue for the purpose of
transparent hospital partnerships.’’ system. In addition, the requirements facilitating organ, eye, or tissue
The fourth strategy discussed in the would further the efficient donation and transplantation.’’
study is to offer flexible work administration of the Medicare program. Our reasons for proposing this
environments and other benefits. At As we stated earlier, section 1102 of the requirement are three-fold. First, it
Mid-America Transplant Services in St. Act grants the Secretary the authority to would bring data reporting requirements
Louis, OPO staff are given specialized establish requirements necessary for the for OPOs into agreement with those for
roles in the donation process based on efficient administration of the Medicare transplant hospitals. Hospital
their professional experience. Staff have program. regulations at 42 CFR 482.45(b)(3)
the flexibility to work from home and require transplant hospitals to provide
are given financial incentives when they Condition: Reporting of Data (Proposed organ-transplant-related data as
meet performance targets. § 486.328) requested by the OPTN, the SRTR, and
The fifth strategy noted in the study [If you choose to comment on this the OPOs. Transplant hospitals must
is to provide opportunities for section, please include the caption also provide those data directly to the
professional growth and development. ‘‘Reporting Data’’ at the beginning of Department when requested by the
The Report’s authors provide many your comments.] Secretary. Ensuring a flow of data
examples of the opportunities that the The current regulations (§ 486.310) between transplant hospitals and OPOs
high-performing OPOs provide to their require an OPO to submit data to us promotes collaboration and can enable
staffs. For example, since most ‘‘family annually showing the number of donors, transplant hospitals to improve their
support coordinators’’ at Donor alliance the number of kidneys and extra-renal programs. For example, a transplant
have non-clinical backgrounds, the OPO organs procured, and the number of hospital can use data from OPOs in its
provides extensive training in the kidneys and extra-renal organs QAPI program, such as data that allow
medical suitability of organ donors. In transplanted so that we can determine it to compare its transplantation rates
with those of other transplant hospitals Services released a report on the CoP (AOPO) determined what data should
in the OPO’s service area or data titled, ‘‘Medicare Conditions of be reported to the OPTN (and, in turn,
showing how many times and for what Participation for Organ Donation: An reported by the OPTN to HRSA and
reasons the hospital’s own transplant Early Assessment of the New Donation CMS). As stated earlier in this preamble,
programs have turned down organ offers Rule.’’ The OIG found that OPOs and in September 2001, OPOs began
from the OPO. hospitals had not yet taken full reporting the following hospital-specific
Second, CMS Regional Office OPO advantage of the CoP. The OIG noted, data electronically to the OPTN: (1) The
Coordinators need data from OPOs to ‘‘Maximizing organ donation requires number of referral calls received from
target areas for improvement both in coordination and collaboration between hospitals; (2) the number of potential
OPOs and hospitals, and third, the OIG hospitals and OPOs. The donation rule, donors; and (3) the number of consents
has recommended CMS use hospital- however, is contained in the Medicare to donation. The OPTN calls for OPOs
specific data provided by OPOs to conditions of participation for hospitals. to report the number of donors and the
monitor the impact of the hospital CoP While it provides OPOs with significant number of organs recovered at each
and improve hospital compliance with leverage that they can use to work with hospital. In the future, as data needs are
the CoP. In short, we believe these data hospitals on donation, the rule places identified (for example, the number of
reporting requirements for OPOs are the obligation for compliance solely on deaths in each hospital), the OPTN may
necessary for the efficient hospitals; it sets no requirements for begin collecting additional data. We can
administration of the Medicare program OPOs. Effective implementation of the obtain data from the OPTN through
and can be required based on the donation rule requires accountability on HRSA at any time. OPOs currently
Secretary’s authority under section 1102 behalf of both OPOs and hospitals.’’ report data to the OPTN within 30 days
of the Act. The OIG recommended that to of the end of the month in which a
We would note that most OPO data increase OPO accountability, we require death occurs, and we propose requiring
needed by us or other agencies within OPOs to provide hospital-specific data that OPOs continue to report their data
the Department can be obtained from on referrals and organ recovery. The within this time frame. However, if an
the OPTN or the SRTR. In fact 42 CFR OIG stated that obtaining data from OPO determined through death record
121.11(b)(2) requires OPOs and OPOs would be the most effective and reviews or by other means that the data
transplant hospitals to submit efficient way to monitor the CoP and it reported to the OPTN was incorrect,
information about tranplant candidates, assess hospital compliance because we would require the OPO to report the
transplant recipients, organ donors, OPOs already collect the necessary data corrected data to the OPTN within 30
transplant program costs and and have them readily available. The days of the end of the month in which
performance, and ‘‘other information report states, ‘‘We believe that OPOs the error was identified.
that the Secretary deems appropriate.’’ could reasonably, inexpensively, and The OIG report recommended that we
We would not request data from OPOs easily provide current data on a require OPOs to make hospital-specific
if the data were readily available from quarterly basis.’’ donation performance data publicly
other sources. We are including this We agree with the OIG’s conclusions. available in order to recognize hospitals
provision only to give us and other Although all OPOs collect hospital- that do a good job. They pointed out
entities the flexibility to request data specific data on referrals and organs that one OPO in the nation already
from OPOs if data cannot be obtained recovered, current regulations do not publishes organ donation data for every
expeditiously from other sources. The require OPOs to share these data with hospital in its service area. We agree
Secretary would use such data and other us, and OPOs have been reluctant to that the efforts of hospitals that
information for monitoring of hospital share data with us voluntarily lest they collaborate with their OPOs and support
compliance with the CoP, monitoring of affect their collegial relationships with organ donation should be recognized.
OPO compliance with the process their hospitals. Therefore, we must rely Publication of those data has the dual
performance measures and other on surveys performed by the Joint effect of recognizing the efforts of good-
requirements, and assisting OPOs with Commission on Accreditation of performing hospitals, while holding
their QAPI programs. Healthcare Organizations (JCAHO) and hospitals more accountable for organ
We propose including language that State survey agencies to monitor donation. In addition, as we note
defines how OPOs should report data hospital compliance. However, JCAHO elsewhere in this preamble, if OPOs
for donors and organs procured and surveys usually are performed only once report the same hospital-specific data
transplanted to ensure that all OPOs are every 3 years and State Medicare publicly that they report to the OPTN,
following the same reporting protocol. A surveys are performed even less the published data would provide an
uniform process would ensure accurate frequently. Moreover, requirements for additional opportunity to verify the
reporting and will enable us to make a organ, tissue, and eye procurement are completeness and accuracy of the OPTN
true comparison of the OPOs’ only a small part of hospital data. Furthermore, publication of
performance. We propose including accreditation and certification surveys, hospital-specific organ donation data
reporting protocols for the following: and surveying for those requirements would be an effective way to promote
‘‘kidneys procured,’’ ‘‘kidneys may have a lower priority than the exchange of information among
transplanted,’’ extra-renal organs surveying for requirements affecting OPOs, hospitals, and the public.
procured,’’ and ‘‘extra-renal organs direct patient care. In fact, the OIG Therefore, we propose requiring OPOs
transplanted.’’ For example, under noted that some hospitals reported to to report hospital-specific organ
‘‘kidneys procured,’’ en bloc kidneys are them that surveyors asked only to see donation data, including organ donor
counted as two kidneys procured. their policies and procedures for organ potential and the number of actual
Under ‘‘extra-renal organs procured,’’ a donation and did not probe further to organ donors, at least annually to the
heart and two lungs recovered from one determine whether the hospital was public. We would suggest that OPOs
donor would count as three organs complying with all requirements in the include these data in their newsletters
procured. regulation. and their annual reports.
In August 2000, the Office of the Based on the OIG’s recommendations, We are interested in other avenues to
Inspector General (OIG) for the HRSA, CMS, and the Association for hold hospitals more accountable for
Department of Health and Human Organ Procurement Organizations organ donation and for implementing
the CoP. In fact, the AOPO has This section incorporates the data investigate two separate cases of
requested that we ask for public maintenance and record keeping Hepatitis C transmission from organ
comment regarding specific actions we requirements now found at donors and to determine whether the
might consider to address problems § 486.304(c)(8). We believe these donors had been tested, why they had
some OPOs have encountered in regard requirements should be retained to not tested positive for Hepatitis C, and
to their hospitals. For example, OPOs ensure that a smooth transition of whether the donors had exhibited signs
have complained to us that hospitals records would occur if an OPO’s service of Hepatitis C that should have been
sometimes refer a brain dead patient area were taken over by another OPO apparent before donation taking place.
only after the patient has been removed and so that OPOs maintain adequate In addition, CMS and the CDC needed
from the ventilator (rendering the information about each donor. We to quickly establish the disposition of
patient medically unsuitable for organ propose that, as in current regulations, all organs recovered from the infected
donation) and that hospital staff an OPO would be required to establish donors to establish whether other organ
physicians sometimes are reluctant to and use an information management recipients were infected. Although some
declare brain death, provide assistance system to maintain the required of the data we propose requiring would
in evaluating potential donors, or medical, social and identifying be available from the hospital where a
provide services for intraoperative information for every donor and donor died, some would be available
donor management. transplant recipient and develop and from the OPTN, and some would be
We believe it is important to point follow procedures to ensure the available from the OPO, it is important
out, however, that in these specific confidentiality and security of the for all data to be available in one
situations (and many others), there is information. location to provide speedy access in
regulatory relief available to OPOs OPOs have asked for guidance cases of disease transmission.
under the hospital and critical access regarding how long records should be In addition, CMS needs access to
hospital CoPs, which requires hospitals kept. We propose requiring OPOs to several of these additional data elements
to refer patients whose death is maintain donor and transplant recipient to determine whether an OPO has
imminent and to cooperate with their records for 7 years because the complied with the process performance
OPOs in maintaining potential donors regulations that govern the OPTN at measures. Donor management, hospital
while necessary testing and placement § 121.11(a)(2)(i) require OPOs to retain history, and past medical and social
of organs takes place. This means that records for 7 years. We also propose history would be used to assess
a hospital could be in violation of the requiring certain additional data that compliance with § 486.344(a) and (b).
CoP if it did not refer a brain dead OPOs would be required to keep in their Consent and next-of-kin information
patient before removing the patient from donor records. would be used to assess compliance
Currently, OPOs are required to
the ventilator or if the hospital did not with § 486.342.
include the following in their donor
provide the support services necessary Finally, we believe the additional data
records: information identifying the
to maintain a potential donor. elements we propose for donor records
donor (for example, name, address, date
We are aware that OPOs are reluctant of birth, social security number or other would provide an invaluable source of
to provide details about violations of the unique identifier, such as Medicare information for OPOs to use in their
hospital CoP to us because they fear health insurance claim number), organs QAPI programs. For example, an OPO
disturbing their relationships with and (when applicable) tissues may want to review donors’ medical
hospitals. One OPO has stated, ‘‘it’s not recovered, date of the organ recovery, and social histories to assess and
our intention to find fault with anybody. and all test results. We propose improve its protocol for obtaining
This is a relationship business.’’ requiring the following additional data medical and social histories from
However, the CoP for organ, tissue, and elements: donor management data, potential donor families.
eye procurement has been in effect since current hospital history, past medical
August 1998. We would suggest that if Condition: Requesting Consent
and social history, the pronouncement (Proposed § 486.342)
an OPO has not been able to urge a of death, and consent and next-of-kin
hospital into compliance with the CoP information. We currently require OPOs [If you choose to comment on this
by now, it needs our assistance. We to keep identifying information for each section, please include the caption
cannot aid hospitals and OPOs in transplant recipient. We propose ‘‘Requesting consent’’ at the beginning
improving their relationships and assure requiring OPOs to include a record of of your comments.]
that all hospitals are complying with the the disposition of organs recovered for In addition to requesting consent for
CoP unless OPOs are willing to bring transplantation. organ donation from families of
problems to our attention. Nevertheless, In proposing these new data elements, potential donors, OPOs often request
we are interested in receiving comments we are expanding upon the data consent for tissue donation on behalf of
regarding other actions we might take to elements required for donor records their hospitals’ designated tissue banks.
improve hospital compliance with the under existing regulations at In April 2000, the ‘‘Orange County (CA)
CoP and hold hospitals more § 486.304(c)(8). There are three reasons Register’’ (Register) published a five-part
accountable for organ donation. why we propose requiring these series of articles based on its
[If you choose to comment on this issue, additional data elements. First, such investigation of the tissue banking
please include the caption ‘‘Hospital data is critically necessary to the industry. One of the allegations made by
Accountability’’ at the beginning of your investigation of the transmission of the Register was that tissue donor
comments.] infectious disease from organ donors. families were not being fully informed
Recently, CMS and the Centers for before making the decision to donate.
Condition: Information Management Disease Control and Prevention (CDC) The Register articles noted that families
(Proposed § 486.330) needed donor records (including donor of potential donors often are not
[If you choose to comment on this management data, hospital history, past informed about how donated tissues
section, please include the caption medical and social history, the may be used (for example, skin may be
‘‘Information management’’ at the pronouncement of death, and consent used for cosmetic surgery, as well as
beginning of your comments.] and next-of-kin information) to grafts for burn patients) or that some
tissue banks make profits from donated may have executed a consent or We would note that a recent survey of
tissues. indicated in an advance directive or tissue donor families conducted by the
In January 2001, the OIG published a power of attorney the individual who National Donor Family Council and
report entitled, ‘‘Informed Consent in will make a decision about organ Case Western Reserve University found
Tissue Donation.’’ The OIG noted that in donation on his or her behalf. The OIG that a large majority of families said
recent years, tissue banking and appended to its report a list of model they would have preferred receiving
processing practices have gradually elements of informed consent for organ more, rather than less, information to
diverged from tissue donor families’ and tissue donation developed by the aid them in their decision making. For
expectations. The expansion of the American Association of Tissue Banks, example, 79 percent of families
tissue banking industry, new AOPO, and the Eye Bank Association of surveyed said they would have wanted
technology, large profits, and tissue America, as well as an informed consent to know that some tissue banks are for-
marketing practices have raised policy for tissue donation developed by profit entities. To guarantee that all
questions about the non-profit basis of the National Donor Family Council. We donor families and other individuals
tissue banking. Therefore, the OIG have incorporated many of the responsible for making donation
suggested that certain steps should be recommendations made by these decisions have the information they
taken in regard to tissue donation to organizations into our proposal. need to make an informed decision, as
ensure that families and other decision- For example, the OIG noted that well as to avoid a negative impact on
makers are fully informed before making although tissue donor families assume organ and tissue donation, we believe
a decision. One of the OIG’s the tissue they agree to donate will be information should be provided about
recommendations was that we add a used to meet important medical needs, all facets of the donation process before
provision to the OPO conditions for tissue is sometimes processed into a donation decision is made.
coverage to hold OPOs accountable for products used for elective cosmetic Finally, the family of the donor is
obtaining informed consent from tissue procedures. Tissues may also be used likely to have many questions about the
donor families when OPOs request for research or education rather than donation process, even if the OPO does
consent on behalf of tissue banks. The transplantation. To address this issue, not request consent. Thus, although we
OIG also recommended that we require the National Donor Family Council do not propose requiring an OPO to seek
OPOs to include tissue banks when recommends that tissue donor families informed consent if the potential donor
developing and conducting training for be told they may restrict or limit use of consented to donation before his or her
hospital designated requestors for the tissue they donate. We agree with death in a manner that satisfied the
tissue. this recommendation and propose governing State law requirements, we
We agree with the OIG’s propose requiring the OPO to provide
requiring that individuals responsible
recommendations. Providing informed information about the donation if it is
for making the donation decision be
consent is an integral part of requested by the donor’s family.
informed that they may limit or restrict
encouraging discretion and sensitivity
the use of donated organs or tissues. Condition: Donor Evaluation and
with respect to the circumstances,
views, and beliefs of potential donor In addition, we propose requiring Management and Organ Placement and
families, which is required for hospitals OPOs to provide to the individual(s) Recovery (Proposed § 486.344)
and critical access hospitals under responsible for making the donation [If you choose to comment on this
section 1138(a)(1)(A)(ii) of the Social decision, at a minimum, a list of the section, please include the caption
Security Act, in hospital regulations at organs or tissues that may be recovered; ‘‘Donor evaluation and management,
§ 482.45(a)(4), and in critical access a description of all possible uses for the organ placement and recovery’’ at the
hospital regulations at § 485.643, and donated organs or tissues; information beginning of your comments.]
which we propose as a requirement for (such as non-profit or for-profit status) The current OPO regulations have
OPOs in this proposed rule. Ensuring about organizations that will recover, minimal requirements for donor
that all donor families and other process, and distribute the tissues; a evaluation and management and organ
individuals responsible for making description of the screening and placement and recovery. They require
donation decisions are fully informed recovery processes; information OPOs only to: (1) Have a system to
before making a decision guards against regarding access to and release of the allocate donated organs equitably
negative publicity that may result if a donor’s medical records; an explanation among transplant patients consistent
donor family does not receive informed of the impact the donation process may with specific CDC guidelines for
consent. As noted earlier in this have on burial arrangements and the preventing the transmission of HIV and
preamble, negative perceptions of or appearance of the donor’s body; with the rules of the OPTN; and (2)
publicity about tissue donation can information about the procedure for ensure that appropriate donor screening
affect the public’s attitude about organ filing a complaint; contact information and infection tests consistent with CDC
donation and individuals’ willingness to in case the individual(s) making the and OPTN guidelines are performed by
donate. Therefore, we propose requiring decision have questions; and a copy of a laboratory certified in the appropriate
that all requests made by OPOs for the signed consent form. specialty or subspecialty in accordance
tissues, as well as organs, include a When developing protocols for with CLIA requirements. There are no
properly executed informed consent informed consent for tissue donation, provisions in our regulations addressing
process. OPOs may wish to review the informed donor management or organ recovery.
An OPO would be required to have a consent policies appended to the OIG We propose requiring every OPO to
written protocol to ensure that, in the report. The National Donor Family have written protocols for donor
absence of a donor document, the Council represents approximately 8,000 evaluation and management and organ
individual or individuals with donor families, and the American placement and recovery. The OPO
responsibility to make the donation Association of Tissue Banks accredits 58 would be required to ensure that
decision are informed of their option to tissue banks in the U.S. Their policies protocols meet current standards of
donate organs or tissues or to decline to include specific descriptions of practice and that established practices
donate. We note that with respect to elements that address full disclosure for and criteria are designed to optimize the
informed consent, a potential donor consent for tissue donation. number of donors and the number of
organs recovered and transplanted per transplanted per donor increased by with part 493 (that is, the CLIA
donor. 11.3 percent. (Chabalewski, F., regulations). Thus, an OPO using its
As stated earlier, our OPO Rosendale, J., Edwards, C.: The Effect of own mobile unit to perform point-of-
Coordinators have observed that the a Critical Care Pathway on Donor care testing for management of donors
most successful OPOs have active, Management Time and Cost—A Pilot before organ recovery would be required
involved medical directors. Therefore, Study. Presented at the American to have the appropriate CLIA
we are proposing requirements to Association of Critical Care Nurses, May certification. The OPO would be
ensure both that every OPO has a 1, 2000.) The Secretary’s Advisory required to ensure that the donor’s
medical director and that medical Committee on Transplantation (ACOT) blood is typed using two separate blood
directors are involved in the day-to-day recently recommended that OPOs be samples. Furthermore, we would
oversight of clinical staff and the staff’s encouraged to develop, evaluate, and require OPOs to document donor
evaluation and management of potential support the implementation of records with all test results, including
donors. We propose that an OPO’s improved management protocols for blood type, before organ recovery.
medical director would be responsible potential donors. The ACOT noted that To provide opportunity for
for ensuring that protocols for the UNOS ‘‘Critical Pathway’’ is a improvements in partnerships between
evaluation and management of donors ‘‘novel and improved’’ standard of care OPOs and the transplant hospitals in
are implemented correctly and for heart and lung donors, and the their service areas, we would require
appropriately to ensure every potential Committee called for development of OPOs to establish protocols
donor is thoroughly assessed for improved management standards for collaboratively with transplant hospitals
medical suitability for organ donation recovery of other types of organs. that clearly define the roles and
and clinically managed to optimize Currently, the CDC’s ‘‘Guidelines for responsibilities of the OPO and the
organ viability and function. Preventing Transmission of Human transplant hospital for all activities
Managing a brain dead potential Immunodeficiency Virus Through associated with donor evaluation, donor
donor so that organs remain Transplantation of Human Tissue and management, and organ recovery.
transplantable is very difficult. In fact, Organs’’ are appended to our OPO In February 2003, a medical error
experienced OPO procurement regulations, but we are not proposing to occurred at a large university hospital
coordinators agree that it can be more include them in our new regulations. that made headlines across the country.
difficult to manage a brain dead Once guidelines are appended to Surgeons at the hospital transplanted a
potential donor successfully than to Federal regulations, agencies can heart and lungs from a type A donor
manage a living, critically ill patient. incorporate new guidelines only into a type O recipient. The recipient
Sometimes donors are lost at this point through the rulemaking process. immediately began to reject the
in the donation process because cardiac Therefore, we propose removing the mismatched organs, and a second
arrest occurs before organs can be CDC guidelines from the OPO transplant several days later from a
recovered. Therefore, we propose that regulations and requiring, instead, that donor of the correct blood type failed to
OPOs be required to implement a OPOs arrange for donor screening and save her life. Although a number of
system that ensures the medical director testing for infectious disease following errors and mistaken assumptions on the
or other qualified physician is available current standards of practice. This part of the hospital and both OPOs
to assist in the medical management of requirement would give OPOs the involved in the procurement of the
a donor when the surgeon on call is flexibility to follow the most up-to-date organs led to the mismatched
unavailable. We believe these proposals guidelines for preventing transmission transplant, it could have been prevented
would ensure that once consent is of infectious disease. We would expect by better communication between the
obtained, every medically suitable OPOs to change their testing practices hospital and the OPOs involved in
potential donor will go to surgery and quickly if the organ donation and procuring and placing the organ.
every transplantable organ will be transplantation community agrees that a Therefore, we propose requiring OPOs
recovered. change is indicated. to include in the protocol the
We believe detailed protocols whose For example, in 2001 three transplant procedures to be used to ensure that the
implementation is well coordinated recipients were infected with the blood type of the donor is compared
between the OPO medical director and parasite that causes Chagas disease after with the blood type of the intended
procurement coordinators would work receiving organs from a donor from recipient by two OPO staff members
to safeguard against outcomes that Central America. One of the recipients before organ recovery takes place and
hinder the goal of optimizing recovery later died from the disease. Chagas that documentation of the donor’s blood
of transplantable organs. The complex disease is endemic in Latin America but type accompanies the organ to the
clinical interventions required for each had not previously been reported in the transplant hospital.
stage of the donor evaluation and United States. Although at present there OPOs would be required to review the
management and organ recovery is no test available in the United States protocols periodically with their
processes contain numerous variables to screen donors or organs for the transplant hospitals to incorporate best
that would benefit from increased presence of Chagas disease, if a test practices and maximize placement of
surveillance and accountability. becomes available and the OPTN and transplantable organs. We believe that
An excellent example of the CDC recommend that OPOs use the test implementation of current,
importance of following a protocol for to screen potential donors, we would comprehensive protocols would
donor management can be found in a regard that testing as being part of improve donor evaluation, management
recent OPTN/UNOS study of the UNOS current standards of practice for donor and organ recovery and contribute to the
‘‘Critical Pathway for the Organ Donor’’ testing. maximum number of organs per donor
protocol for donor management. The We propose requiring that all testing recovered and transplanted.
study found that when the critical of potential donors (including point-of- In our investigation of the
pathway protocol was used, outcomes care testing and blood typing) be mismatched transplant, we found that
improved significantly. The number of conducted by a laboratory that is the OPOs involved did not obtain
organs recovered per donor increased by certified in the appropriate specialty or documentation of the recipient’s blood
10.3 percent, and the number of organs subspecialty of service in accordance type or position on the waiting list from
the OPTN. Therefore, we propose studies and abstracts describing their intended for research. It was only after
requiring that before recovery of an successes in recovering organs from the intended kidney recipient had been
organ for transplantation, an OPO must marginal donors. Gift of Life OPO in anesthetized and surgery had begun that
have written documentation from the Philadelphia presented an abstract hospital staff discovered the OPO had
OPTN showing, at a minimum, the documenting its success in sent a heart instead of a kidney.
intended recipient’s OPTN implementing a comprehensive In investigating the incident, we
identification number and blood type, initiative for recovering organs from discovered that while organ mix-ups are
as well as the recipient’s position on the pediatric donors after cardiac death rare, they are not unheard of, and no
waiting list in relation to other suitable (that is, non-heartbeating donors). From one in the OPO community seemed
candidates. We have included 1995 through 2001, 55 organs recovered surprised that it had happened. In fact,
additional safeguards in this proposed by the OPO from pediatric donors after the OPTN/UNOS OPO Committee
rule (see § 486.346) to prevent cardiac death were successfully recently documented 15 instances of
mismatched transplants. transplanted. Gift of Life also presented organ packaging errors that occurred
Section 371(b)(3)(E) of the PHS Act an abstract demonstrating the number of over a period of only 6 months. These
requires OPOs to ‘‘have a system to viable organs they recovered from errors included three organs shipped
allocate donated organs among donors over the age of 60 and a case without sufficient ice, a right kidney
transplant patients according to study describing how optimal donor shipped instead of the left kidney
established medical criteria.’’ The OPTN management, biopsy, and perfusion expected by the transplant hospital, a
develops the medical criteria upon enabled them to recover viable kidneys vessel container leaking (thus
which allocation policies are based with from a donor with initially poor kidney compromising the sterile integrity of
the input of the organ donation and function. segments of the donor’s aorta and
transplantation community. Therefore, inferior vena cava intended for use in
we propose retaining the requirement in Condition: Organ Preparation and the transplant procedure), as well as
the current regulations that OPOs have Transport (Proposed § 486.346) other errors that may have resulted in
a system to equitably allocate donated [If you choose to comment on this organ wastage. Although the OPTN has
organs among transplant patients section, please include the caption packaging requirements for OPOs,
consistent with the rules of the OPTN. ‘‘Organ preparation and transport’’ at clearly, the requirements have not been
However, we propose adding language the beginning of your comments.] sufficient to prevent errors that waste
to clarify that the ‘‘rules’’ of the OPTN Our current regulations have minimal organs and endanger recipients. In light
are those that have been approved as requirements for OPOs for organ of the critical nature of the organ
enforceable by the Secretary. preparation and transport. OPOs are shortage, such errors are unacceptable.
We are proposing a requirement that required only to arrange for appropriate Finally, an OPO would be required to
OPOs develop and implement a tissue typing of organs and to provide or mark all packaging in which organs are
protocol that maximizes placement of arrange for transportation of organs to transported with the identification
transplantable organs. This means that transplant hospitals. There are no number, specific contents, and donor’s
OPOs should be aware of organ requirements for organ packaging in the blood type. This requirement is one of
acceptance criteria for centers outside current regulations. our proposals to guard against
their service areas and make every We propose requiring OPOs to arrange transplantation of organs mismatched
possible effort to place healthy organs. for testing of organs for infectious by blood type or delivery of the wrong
We would encourage OPOs to include disease and tissue typing of organs organ to a transplant center.
organ placement in their QAPI programs according to current standards of
and explore innovative ideas for practice. The OPO would be required to Condition: Quality Assessment and
maximizing both organ recovery and ensure that testing and tissue typing of Performance Improvement (QAPI)
transplantation. organs are conducted by a laboratory § 486.348
According to the Collaborative’s that is certified in the appropriate [If you choose to comment on this
report, LifeLink of Florida evaluates specialty or subspecialty of service in section, please include the caption
every brain death on-site at the hospital, accordance with part 493 of this ‘‘Quality Assessment and Performance
regardless of the patient’s age, medical chapter. Improvement’’ at the beginning of your
history, or social history, and makes We propose requiring OPOs to comments.]
every effort to find potential recipients develop and follow a protocol for There is no requirement in current
for marginal or ‘‘extended criteria’’ packaging, labeling, handling and regulations that OPOs have a QAPI
organs. LifeGift’s philosophy includes transporting organs in a manner that program. Although our regulations for
‘‘turning potential donors previously ensures their arrival without most Medicare providers and suppliers
considered unsuitable into actual compromise to the quality of the organ require, at the least, a quality assurance
donors.’’ or the health of the recipient. OPOs program (the ‘‘find a problem, fix it’’
Many OPOs have developed would be required to include approach), there is no corresponding
innovative methods for maximizing the procedures to check the accuracy and requirement in the OPO regulations.
number of organs they place and integrity of labels, packaging, and QAPI is the process of using objective
recover. For example, the Hawaii OPO contents before transport, including two data to study and continually make
has partnered with a California separate verifications of the data on the improvements to all aspects of an
transplant hospital to arrange for hearts labels and in the documentation that organization’s operations and services.
donated in Hawaii to be transplanted in accompanies an organ to a transplant QAPI rests on the assumption that an
California, even though the transport center. organization’s own quality management
time to California is at the upper limits The impetus for this proposal came system is the key to improved
of the acceptable cold ischemic time for from an incident that occurred in performance. It seeks to increase the
a heart. At the July 2002 meeting of the Illinois in 2000. In packaging organs for amount and quality of information on
North American Transplant shipment, an OPO mixed up the label which to base decisions and improve
Coordinators Organization in identifying a kidney intended for quality. QAPI programs allow health
Washington, DC, OPOs presented case transplantation with the label for a heart care entities to assess their functioning
continuously and make changes to However, AOPO notes that due to measures to evaluate and demonstrate
improve their quality and efficiency. several factors, there has been improved performance with regard to
QAPI is regarded by the health care significant growth in quality OPO activities.
community as the most efficient and improvement among OPOs since the These requirements are based on our
effective method for improving the November 2001 survey. These factors commitment to encouraging continuous
quality and performance of health care include: (1) The Department’s quality improvement for all Medicare
providers. QAPI has become so Breakthrough Collaborative, which providers and suppliers. As we develop
pervasive that in a recent publication of utilizes QAPI-type strategies to improve new regulations, we are shifting our
the Institute of Medicine (IOM) of the donation rates; (2) the Department’s focus from targeting the substandard
National Academy of Sciences, initiative to provide comparative data practices of a small number of poor
‘‘Crossing the Quality Chasm: A New from the SRTR to all OPOs and the performers to emphasizing the
Health System for the 21st Century,’’ the public; (3) new perspectives on quality responsibility of all Medicare providers
IOM recommended that the Department improvement gleaned from individuals and suppliers for continuous quality
itself should monitor and track quality hired by OPOs from outside the OPO improvement in their own
improvements in six key areas including community; (4) sharing of quality organizations. QAPI is a regulatory
safety, effectiveness, responsiveness to improvement plans among OPOs; and requirement for hospitals, Medicare +
patients, timeliness, efficiency, and (5) the growth and activism of AOPO’s Choice providers, and providers in the
equity. Quality Council. These factors have Program for All-Inclusive Care for the
However, as the focus on improving provided all OPOs with opportunities to Elderly (PACE). QAPI has been
outcomes in health care shifted from expand and improve their quality proposed as a requirement for home
quality assurance to QAPI, OPOs improvement programs. health agencies and rural health clinics.
seemed to be left behind, perhaps All six high-performing OPOs studied We believe a requirement for OPOs to
because they do not provide hands-on during the Organ Donation have a QAPI program will encourage
health care to patients. Nevertheless, an Breakthrough Collaborative have a continuous quality improvement, as
OPO’s success in recovering healthy process (such as death record reviews) well as the use of best practices, as
organs impacts patients who need for collecting hospital-specific data and determined by the individual OPO and
transplants due to end-stage organ using the data both in their hospital the OPO community.
development programs and to effect We do not intend to stipulate specific
failure just as surely as if the OPO were
change within their own organizations. activities an OPO must include in its
providing direct care to those patients.
New England Organ Bank collects and QAPI program. However, we suggest
Although some OPOs have strong that all OPOs track and take actions to
monitors hospital-specific data on
QAPI programs and use them to effect improve their consent rates. Although
requests, consents, organs recovered,
change both within their own knowledge is the foundation for
and organs transplants and reviews the
organizations and within their hospitals, performance improvement, some OPOs
data with hospital leadership every
some OPOs’ QAPI programs are do not know their consent rates, either
month. Included in their QAPI program
inadequate to drive badly needed for their service area as a whole or for
are ‘‘formalized feedback mechanisms,’’
systemic changes. Some OPOs admit such as weekly meetings with OPO staff, individual hospitals. Nationwide, the
that, as a group, they tend to be reactive monthly meetings with hospital staff, consent rate to organ donation hovers
rather than proactive, fixing individual post-donation briefings with all around 50 percent, and it is generally
problems instead of systems. involved OPO and hospital staff, along agreed that families’ failure to consent
Nonetheless, it appears that OPOs are with two data reporting mechanisms to donation is the single most important
catching up with the rest of the health (quantitative and qualitative reports). roadblock to increasing donation.
care community. We know that most We believe it is critical for every OPO Although there is some evidence that
OPOs have a quality improvement to have such a comprehensive QAPI public education efforts targeted toward
program. Some programs are program (that is, a program that increasing the public’s awareness of and
comprehensive, highly structured, and addresses all aspects of an OPO’s support for organ donation may result in
completely integrated into the day-to- functioning and the functioning of its an increase in consent rates, the single
day operations of the OPO. OPOs with hospitals in the organ donation process). greatest opportunity for increasing
these programs utilize them for data- As a recent article describing consent rates lies within the interaction
based decision making and strategic characteristics of successful OPOs among OPO staffs, hospital staffs, and
planning. Other OPOs are still pointed out, ‘‘OPOs no longer have the potential donor families.
developing and formalizing their QAPI luxury of using trial and error in We propose requiring an OPO’s QAPI
programs. determining which programs will program to include objective measures
In November 2001, AOPO conducted increase organ donation, which factors to evaluate and demonstrate improved
a survey to assess quality improvement are key for success.’’ (Shafer, T., Kappel, performance with regard to OPO
programs among OPOs. Of the 35 OPOs D., Heinrichs, D., Strategies for success activities, such as hospital development,
that responded to the survey, among OPOs: a study of three organ designated requestor training, donor
approximately 40 percent had been procurement organizations. Journal of management, timeliness of response to
developing a quality program for 2 years Transplant Coordination. V.7, No.1: 22– hospital referrals, consent practices,
or less, and only 43 percent had 31.) organ recovery, and organ packaging
designated an individual whose primary Therefore, we are proposing a and transport. The OPO would be
responsibility was coordinating and requirement for every OPO to develop, required to take actions that result in
monitoring a quality improvement implement, and maintain a performance improvements and track
program. However, approximately 67 comprehensive, data-driven QAPI performance to ensure that
percent had made quality improvement program designed to monitor and improvements are sustained.
part of their strategic plans and had evaluate all donation services, including There are many resources available to
developed appropriate measures or services provided under contract or OPOs to develop and improve QAPI
indicators of work system effectiveness arrangement. The OPO’s QAPI program within their organizations. The AOPO
for most major activities. must include the use of objective Quality Council is available to assist all
AOPO members interested in QAPI. The that to have sufficient data on which to critical care units in the hospital. The
Council has a quality improvement list base changes in their organizations, OPO partnered with the hospital to
serve and a chat room used for OPOs must perform death record increase organ donation rates. The OPO
mentoring and for scheduled reviews on an ongoing basis. Death made a commitment to (1) Respond on
discussions of quality improvement record reviews provide information site to every referral; (2) provide
topics. The Council holds meetings for about nearly the entire range of an monthly in-service education to resident
all interested OPOs three times per year, OPO’s critical operations, as well as the physicians in the key units; and (3)
with training in basic and intermediate performance of the OPO’s hospitals in follow up on all cases within 96 hours
level QAPI, basic quality assurance the donation process. Death record of every referral to obtain information
statistics and data analysis, reviews provide information about the for improving systems for donation. The
implementation of quality plans, flow timeliness of hospital referrals of result—from 2000 to 2001, the hospital’s
charting, root cause analysis, and potential donors, the timeliness of the organ donation rate increased by 48
preparation for audits and surveys. OPO’s response, OPO or hospital staffs’ percent to 40 donors and the rate of
In addition, the resources of both interactions with family members, organs recovered increased by 43
CMS (through the OPO Coordinators) management of potential donors, and percent to 143 organs.
and HRSA’s Division of Transplantation other matters that affect quality. The At the Joint American Transplant
(DOT) are available to OPOs to assist information OPOs gain from periodic Meeting, ‘‘Transplantation 2001’’
them in implementing QAPI. CMS OPO death record reviews can be used to conference held from May 11–16 2001
Coordinators are always available to identify and correct systemic problems in Chicago, a group of researchers,
assist OPOs with their QAPI programs. that interfere with organ donation. including the researchers from the
Once a final rule is published, the CMS In a 1997 article, ‘‘Medical Record AOPO death record review study,
OPO Coordinators will provide Review as a Measure of the presented results from a study that used
guidance to OPOs so that they Effectiveness of Organ Procurement death record reviews to understand
thoroughly understand how to Practices in the Hospital,’’ [The Joint opportunities for increasing organ
implement the QAPI requirements in Commission Journal on Quality donation within an OPO service area.
the regulation. Improvement, Vol. 23, No. 6, June 1997] The researchers concluded that: (1)
When OPOs are surveyed to see if The Partnership for Organ Donation Increasing organ donation can be
they meet the requirements for QAPI, concluded that death record reviews achieved by focusing on hospitals with
surveyors initially would focus on provide a solid foundation for 150 or more beds known to have organ
whether an OPO has or is developing a identifying gaps in organ procurement donor potential by death record review;
QAPI program. If a QAPI program were performance, implementing and (2) death record reviews offer an
still in the development phase, tracking the success of [quality objective way to prioritize hospitals by
surveyors would determine what improvement] initiatives, and potential and to tailor interventions
remains to be accomplished, what steps monitoring ongoing performance The within each hospital to address specific
the OPO needed to take to have a researchers recommended that OPOs obstacles to donation; and (3) by
comprehensive, fully integrated conduct death record reviews annually focusing on hospitals with 150 or more
program, and what resources it would at large hospitals where medically beds, OPOs can reach more than 90
need to reach that goal. When an OPO suitable donor candidates are percent of their target market.
is surveyed for the QAPI requirement concentrated and provide feedback from Therefore, we propose that an OPO be
for the first time under the final OPO the death record reviews to key hospital required to conduct death record
rule, the OPO would not be cited for staff concerning practice improvements reviews in every Medicare or Medicaid
being out of compliance, as long as it that could be adopted. The researchers participating hospital with which it has
had a QAPI program in some stage of suggested annual death record reviews an agreement if the hospital has 150 or
development and was working to at hospitals with 150 or more beds or more beds or if it has a level I or level
expand and improve the program with with trauma centers. II trauma center, with the exception of
the goal being a comprehensive, data- As stated earlier, the organ donation psychiatric or rehabilitation hospitals.
driven program to monitor and evaluate community recognizes that death record (We propose excluding psychiatric and
all donation services. reviews are the ‘‘gold standard’’ for rehabilitation hospitals because of their
The hospital CoP at § 482.45(a)(5) and assessing donor potential and improving limited organ donation potential.) When
critical access hospital CoP at § 485.643 organ donation rates. In fact, in missed opportunities for donation are
require hospitals to cooperate with discussions with directors of OPOs that identified, the OPO would be required
OPOs in reviewing death records to perform death record reviews, we were to implement actions to improve
improve identification of potential told that OPOs that do not perform them performance.
donors. We included this requirement are ‘‘missing the boat’’ because they As part of the QAPI process, an OPO
in the hospital and critical access have no way of knowing their true would be required to investigate adverse
hospital CoPs because missed donor potential and no way of events and complete a thorough
opportunities for donation are not identifying and addressing problems. analysis. An adverse event for an OPO
uncommon, and review of hospitals’ Although death record reviews are labor could be caused by mismanagement of
death records is essential for both OPOs intensive, they are well worth the effort a donor, failure to test organs for
and the hospitals they serve to expended. infectious disease, failure to compare
determine where and how systems need The Michigan OPO, Gift of Life, the blood type of the donor with the
to be changed to ensure future potential recently demonstrated what can be blood type of the intended recipient, or
donors are identified. accomplished by using death record mixing up the labels on packaged
We propose requiring hospital death reviews as the basis for improving organ organs. Examples of situations involving
record reviews as a component of every donation rates. The OPO used data from direct patient outcomes that might
OPO’s QAPI program. OPOs would be death record reviews performed qualify as adverse events include but are
expected to use data from their death monthly in Michigan’s leading organ not limited to: (1) Avoidable loss of a
record reviews as the basis for their donation hospital to determine that medically suitable potential donor for
quality improvement efforts. We believe organ donors could be increased in key whom consent for donation has been
obtained; (2) avoidable loss of a viable conditions for coverage for OPOs was barriers to donation, along with public
organ; (3) transmission of infectious re-designated from part 485, subpart D education programs designed to address
disease to a recipient, and delivery to a to part 486, subpart G. When this re- those barriers, may result in increased
transplant center of the wrong organ (for designation occurred, these two rates of consent to donation among
example, a left kidney instead of a right references were not amended to reflect targeted populations, the OPO
kidney or a kidney instead of pancreas) the change. community appears to lack consensus
or an organ whose blood type does not In addition, § 413.202 refers to OPOs about this issue. Therefore, we have not
match the blood type of the intended ‘‘as defined in § 435.302 or this included requirements for public
recipient. chapter’’. This is an error. We propose education in this proposed rule.
In addition, we are proposing that an correcting this reference to read ‘‘as However, we are specifically requesting
OPO be required to report an adverse defined in § 486.302 of this chapter’’. comments on the advisability of
event to us within 10 business days of requiring OPOs to conduct public
becoming aware of the event and Request for Comments on Related Issues
education based on systematic
provide written documentation of the Living Donation evaluation of specific barriers to
investigation and analysis of the adverse donation within their individual service
event to us within 15 days of becoming [If you choose to comment on this
section, please include the caption areas.
aware of the event. The OPO would be
required to implement changes and ‘‘OPO role in living donation’’ at the III. Collection of Information
safeguards to decrease the probability of beginning of your comments.] Requirements
the adverse event recurring. We believe In 2001, living donors outnumbered
deceased donors for the first time, with Under the Paperwork Reduction Act
that this formal analysis is essential to of 1995, we are required to provide 60-
examining an OPO’s existing policies 6,445 living donors and only 6,077
deceased donors. However, with the day notice in the Federal Register and
and practices, improving the organ solicit public comment before a
donation process, and improving exception of two pilot programs in
which OPOs assist transplant hospitals collection of information requirement is
outcomes. We believe the proposed time submitted to the Office of Management
frames for reporting and providing by arranging for medical and
psychological evaluations of voluntary and Budget (OMB) for review and
written documentation would be approval. In order to fairly evaluate
sufficient and would ensure prompt living kidney donors, the 59 OPOs do
not play a role in living donation; their whether an information collection
attention by the OPO to adverse events. should be approved by OMB, section
We believe the requirements we mission is to increase the number of
deceased donors. Given the 3506(c)(2)(A) of the Paperwork
propose for OPOs to develop and Reduction Act of 1995 requires that we
implement QAPI programs, perform demonstrated risks to donors (primarily
living liver donors), we believe that solicit comment on the following issues:
death record reviews, report and • The need for the information
analyze adverse events, and operate living donation should remain a
medical decision between individuals collection and its usefulness in carrying
under a CAP, as needed, would provide out the proper functions of our agency.
concrete steps OPOs can use to improve interested in donating and their
physicians. However, in view of the • The accuracy of our estimate of the
their operations and increase organ
increasing importance of living information collection burden.
donation. We also believe these
donation, we are specifically requesting • The quality, utility, and clarity of
proposed requirements are the single
public comments on what role, if any, the information to be collected.
most important provision in this
OPOs should play in living donation. • Recommendations to minimize the
proposed rule to fulfill the
information collection burden on the
congressional mandate for process Public Education affected public, including automated
performance measures based on
[If you choose to comment on this collection techniques.
empirical evidence of organ donor
potential and other related factors in section, please include the caption We are soliciting public comment on
OPO service areas. ‘‘Public Education’’ at the beginning of each of these issues for the following
your comments.] sections of this document that contain
Additional Conforming Changes The current regulations at information collection requirements
(§ 413.200, (§ 413.202, § 441.13, and § 486.306(p) require that OPOs conduct (ICRs):
§ 498.2) and participate in professional General Requirements (§ 486.304)
In addition to the changes discussed education concerning organ
above, we are also proposing a number procurement, but they do not contain a For designation purposes, an
of conforming and correcting requirement for public education. organization would have to meet
amendments. However, most OPOs are aware of the specified requirements, including:
As discussed previously, we propose importance of the role public education It would have to have accounting and
making changes to § 498.1 to remove plays in reaching ethnic populations, other fiscal procedures necessary to
OPOs from the definition of ‘‘supplier’’ dispelling myths about organ donation, assure the fiscal stability of the
under part 498. Since we propose a and addressing other issues that create organization, including procedures to
process for OPOs to appeal a de- barriers for consent to donation. Many obtain payment for organs provided to
certification on substantive and in the OPO community believe that transplant centers.
procedural grounds, OPOs would not targeted public education about organ It would have to submit to CMS a
need the part 498 appeals process. donation plays a key role in overcoming written application for designation,
We also propose to correct a number these barriers. Some researchers using the application form prescribed by
of cross-references related to the however, believe that available funding CMS.
certification of OPOs. In § 441.13(c), and should go to basic research, professional It would have to document that it has
in § 498.2, we propose to change education, and hospital development a defined service area that meets the
references to ‘‘part 485, subpart D’’ to rather than public education. requirements of § 486.306.
read, ‘‘part 486, subpart G’’. On While we believe that systematic An OPO would have to enter into an
September 29, 1995 (60 FR 50447), the efforts by OPOs to identify specific agreement with CMS. In the agreement,
the OPO would have to agree to do with the newly designated OPO or have to send written notice of its
comply with the following ICRs: submit a request for a waiver in intention with the proposed effective
(1) Maintain compliance with cited accordance with paragraph (e) of this date to CMS. In the case of voluntary
laws, regulations and rules of the OPTN, section within 30 days of notice of the termination, the OPO would have to
as defined by § 486.20, and to report change in designation. give prompt public notice of the date of
promptly to the Secretary any failure to A hospital would be able to request termination, and such information
do so. and CMS might grant a waiver regarding the effect of that termination
(2) File a cost report in accordance permitting the hospital to have an as CMS may require, through
with § 413.24(f) of this chapter within 5 agreement with a designated OPO other publication in local newspapers in the
months after the end of each fiscal year. than the OPO designated for the service service area. In the case of involuntary
(3) Provide budget or cost projection area in which the hospital is located. To termination, CMS gives notice of the
information as may be required to qualify for a waiver, the hospital would date of termination.
establish an initial interim payment have to submit data to CMS establishing The burden associated with these
rate. that— requirements is the time it would take
The ICRs in this section are those that (1) The waiver is expected to increase to send written notice to CMS and to
would require an OPO to have organ donations; and publish pertinent information in the
accounting and other fiscal procedures; (2) The waiver will ensure equitable local newspapers. We estimate that one
to submit a written application for treatment of patients referred for OPO would be affected by these
designation, using a form prescribed by transplants within the service area requirements per year.
CMS; to enter into an agreement with served by the hospital’s designated OPO Under 5 CFR 1320.3(c), a ‘‘collection
CMS; and to document that it has a and within the service area served by of information’’ does not include
defined service area that meets specified the OPO with which the hospital seeks requirements imposed on fewer than ten
requirements. to enter into an agreement. entities. Therefore, the ICRs of this
These ICRs are currently approved The burden associated with this section are not subject to the PRA.
under OMB approval #0938–0512. section is the time it would take a
hospital to request a waiver and to Appeals (§ 486.314)
OPO Service Area Size Designation and create an agreement with an OPO. We
Documentation Requirements Under this section, if an OPO’s de-
estimate that there will be 6 hospitals certification is due to involuntary
(§ 486.306) that would request a waiver and that all termination or non-renewal of its
Under this section, an OPO would of these would need to enter into an agreement with CMS, the OPO may
have to make available to CMS agreement with the designated OPO. appeal the de-certification on
documentation verifying that the OPO Under 5 CFR 1320.3(c), a ‘‘collection substantive or procedural grounds. The
meets the requirements of paragraph (b) of information’’ does not include OPO must file its appeal within 30
and (c) of this section at the time of requirements imposed on fewer than ten calendar days of the date of the notice
application and throughout the period entities. Therefore, the ICRs of this of de-certification. In its appeal, the
of its designation. section are not subject to the PRA. OPO may submit evidence to
Under paragraph (c), Service area
Changes in Ownership or Service Area demonstrate why it should not be de-
location and characteristics, an OPO
(§ 486.310) certified.
would have to precisely define and
Under this section, a designated OPO The burden associated with this
document a proposed service area’s
considering a change in ownership or in provision is the time it will take an OPO
location through the following
its service area would have to notify to file an appeal. We do not expect to
information:
(1) The names of counties (or parishes CMS before putting it into effect and decertify more than three OPOs in a
in Louisiana) served or, if the service would have to obtain prior CMS given year.
area includes an entire State, the name approval. In the case of a service area Under 5 CFR 1320.3(c), a ‘‘collection
of the State. change that results from a change of of information’’ does not include
(2) Geographic boundaries of the ownership due to merger or requirements imposed on fewer than ten
service area for which U.S. population consolidation, the entities would have entities. Therefore, the ICRs of this
statistics are available. to submit anew the information required section are not subject to the PRA.
(3) Total population in service area. in an application for designation. The Re-Certification and Competition
(4) The number of and the names of OPO would have to provide information Processes (§ 486.316)
hospitals in the service area with an specific to the board structure of the
operating room and the equipment and new organization, as well as operating Under this section, OPOs competing
personnel to retrieve organs. budgets, financial information, or other for the open service area must submit an
The ICR in this section would be that written documentation CMS determines acceptable plan to increase organ
requiring making documentation to be necessary for designation. donation in the open service area. An
available. We believe that it would take The burden associated with this acceptable plan to increase organ
a typical OPO an average of 1 hour to section is the time it takes to gather and donation would, at a minimum:
make the information available. There submit the information CMS needs. We (1) Be based on the competing OPO’s
are 59 OPOs that would have to comply estimate that two OPOs would be experience and success in its own
with this requirement; therefore, there affected annually and that it will be the service area;
would be a total of 59 hours needed to same amount of time it would take a (2) Include an analysis of existing
comply annually. potential OPO requesting designation barriers, both internal and external, to
and is covered under OMB approval increasing organ donation in the open
Designation of One OPO for Each area; and
#0938–0512.
Service Area (§ 486.308) (3) Provide a detailed description of
If CMS changes the OPO designated De-Certification (§ 486.312) specific activities and interventions for
for an area, hospitals located in that area Under this section, if an OPO wishes increasing organ donation in the open
would have to enter into agreements to terminate its agreement, it would area.
The burden associated with this requires all hospitals to have agreements donation and transplantation data to the
requirement is the time it would take to with their OPO. We believe that it OPTN and the SRTR, as directed by the
create the plan and to submit it. We would take an average of two hours to Secretary. The OPO would have to
expect that it would take approximately draft an agreement with a hospital. provide hospital-specific data directly to
16 hours to develop an acceptable plan transplant hospitals, annually. In
Condition: Administration and
to increase organ donation. In each of addition, the OPO would be required to
the 1996, 1998, and 2000 re-certification Governing Body (§ 486.324)
provide individually identifiable,
cycles, approximately two to three Under this section, the OPO would hospital-specific organ donation and
OPOs failed the performance standards. have to have bylaws for its board(s) that transplantation and other information to
Therefore, we do not anticipate address conflicts of interest, length of the Secretary, as requested. Such data
terminating more than three OPOs in terms, and criteria for selecting and may include, but are not limited to—
any four-year period. In previous re- removing members. (1) Number of hospital deaths;
certification cycles no more than two A governing body or individual (2) Results of death record reviews;
OPOs have competed for an open would have to have full legal authority (3) Number and timeliness of referral
service area. Therefore, we do not and responsibility for the management calls from hospitals;
believe that more than two OPOs would and provision of all OPO services and (4) Potential donor denominator (as
compete for an open area. Therefore, we would have to develop and implement defined in 486.302);
expect that no more than 6 OPOs would policies and procedures necessary for (5) Data related to non-recovery of
compete for service areas of OPOs being the effective administration of the OPO, organs,
de-certified by CMS. including services furnished under (6) Data about consents for donation;
We propose limiting competition for contract or arrangement, fiscal (7) Number of donors;
the service areas of OPOs that have met operations, and continuous quality (8) Number of organs recovered (by
the conditions of coverage to OPOs that assessment and performance type of organ); and
have met 4 out of 5 outcome measures improvement. (9) Number of organs transplanted (by
at 100 percent of the mean and whose The OPO would have to have a type of organ).
conversion rate of potential donors to procedure to address conflicts of
This section would also require that
actual donors is at least 15 percentage interest for the governing body or
potential donor data reported to the
points higher than the incumbent’s individual described above.
OPTN to be used for OPO re-
conversion rate. It is likely that no more The burden associated with the above
certification would have to include data
than 15 OPOs (those in the upper requirements is the time it would take
for all deaths that occurred in hospitals
quartile) would fall into this category. an OPO to create bylaws and to develop
Therefore, we expect that no more in the OPO’s service area, unless a
policies and procedures necessary for
than 21 OPOs would want to develop an hospital has a waiver to work with a
the effective administration of the OPO.
acceptable plan to increase organ different OPO. If an OPO determines
It is usual and customary business
donation as part of a bid to expand into through death record review or other
practice to have such bylaws, policies,
a new service area. Assuming that it means that the potential donor
and procedures; therefore, there would
would take 16 hours to develop such a denominator data it reported to the
be no additional burden.
plan, the burden would be 336 hours. OPTN was incorrect, it must report the
Condition: Human Resources corrected data to the OPTN.
Condition: Relationships With (§ 486.326) The OPO would have to report
Hospitals, Tissue Banks, and Eye Banks hospital-specific organ donation data to
The first ICR in this section is that we
(§ 486.322) the public at least annually.
would require the OPO to have a written
Under this section, an OPO would policy that addresses conflicts of The burden associated with these
have to have a written agreement with interest for the OPO’s director, medical requirements is the time it would take
95% of the Medicare and Medicaid director, and senior management, and the OPOs to report certain information.
hospitals in its service area that have procurement coordinators. We believe that this would take no more
both a ventilator and an operating room, Another ICR would be that the OPO than 4 hours per OPO per year, or a
that describes the responsibilities of must maintain credentialing records for national total of 236 hours. In addition,
both the OPO and hospital in regard to physicians who routinely recover organs although it appears this requirement has
the requirements for hospitals in in hospitals with which the OPO has an the potential to add a significant new
§ 482.45. The agreement would have to agreement. reporting burden, OPOs are required as
address the requirement in § 486.326 The third ICR is that the OPO would a condition of their membership in the
that the OPO would have to maintain have to reevaluate staff competency at OPTN to report a large amount of data
credentialing records for physicians least yearly and provide individual job to the OPTN (which, in turn, provides
who routinely recover organs in descriptions and performance the data to the SRTR for analysis). For
hospitals under contract or arrangement expectations to staff. example, the cadaver donor registration
with the OPO and would have to assure The burden associated with this form (OMB approval #0915–0157) OPOs
that physicians and other practitioners section is the time it would take an OPO are required to complete for each donor
who recover organs in hospitals are to document policy, maintain records contains more than 300 data elements.
qualified and trained. and to provide job descriptions and In addition, 42 CFR 121.11(b)(2)
The burden associated with these expectations. These requirements reflect requires OPOs and transplant hospitals
ICRs would be the time it will take an usual and customary business practices to submit information about transplant
OPO to enter into an agreement with a and thus do not create any additional candidates, transplant recipients, organ
hospital. Currently, OPOs are likely to burden. donors, transplant program costs and
have agreements with all hospitals in performance, and ‘‘other information
their service areas because the hospital Condition: Reporting of Data (§ 486.328) that the Secretary deems appropriate.’’
CoP for organ, tissue, and eye Under this section, the OPO would Thus, most information needed by the
procurement, which was effective have to provide individually OPTN, the SRTR or the Department is
August 21, 1998 (see section 482.45) identifiable, hospital-specific organ already being reported by OPOs.
We cannot quantify the number of Condition: Informed Consent (§ 486.342) The OPO must document the donor’s
hours it would take to comply with the The ICRs of this section would require record with all test results, including
data reporting requirement, as data that an OPO have a written protocol to blood type, prior to organ recovery.
would be requested on an as-needed ensure that the individual(s) making the Prior to recovery of an organ for
basis. We believe that almost any OPO donation decision for each potential transplantation, the OPO must have
data needed by CMS or other agencies organ donor is informed of their options written documentation from the OPTN
within the Department could be to donate organs and tissues or eyes showing, at a minimum, the intended
obtained from the OPTN or the SRTR. (when the OPO is making a request for recipient’s position on the waiting list
We are including this provision only to tissues or eyes) or to decline to donate in relation to other suitable candidates
give CMS and other agencies the and are given sufficient time to consider and the recipient’s OPTN identification
flexibility to request data from OPOs in their decisions and sufficient number and blood type.
the event that needed data cannot be information on which to base fully The burden associated with this
obtained expeditiously from the OPTN informed decisions. The OPO would requirement is the time it would take to
or the SRTR. We would not request data have to provide to the individual(s) create the protocols. We believe that
from OPOs if the data were readily making the donation decision, at a good business practices would dictate
available from other sources. minimum, the following: that an OPO have written protocols that
Concerning the requirement that (1) A list of the organs, tissues, or eyes meet the requirements of this section.
OPOs give data to the public, almost all to be recovered, Therefore, there would be no additional
OPOs publish newsletters to inform the (2) All possible uses for the donated burden.
public of their activities, and, most organs and/or tissues, Condition: Organ Preparation and
likely, OPOs would report the hospital (3) The information that the Transport (§ 486.346)
data in their newsletters at very little individual(s) have the right to limit or
additional cost. For those OPOs that do restrict use of the organs or tissues, The ICR in this section requires that
not publish newsletters, we estimate (4) A description of the screening and the OPO develop and follow a written
that it would take 4 hours to create a recovery processes, protocol for packaging, labeling,
document suitable for publication (5) Information (such as profit or non- handling and shipping of organs in a
yearly. We estimate that three OPOs do profit status) about organizations that manner that ensures their arrival
not have newsletters, for an annual will recover, process, and distribute without compromise to the quality of
burden of 12 hours. tissue, the organ or health of the recipient. The
(6) Information regarding access to protocol would have to include
Condition: Information Management
and release of the donor’s medical procedures to check the accuracy and
(§ 486.330)
records, integrity of labels prior to transport.
The ICRs under this section would (7) An explanation of the impact the The burden associated with this
require the OPO to maintain a record for donation process will have on burial requirement is the time it would take to
every donor. The record would have to arrangements and the appearance of the create the protocols. We believe that
include, at a minimum, information donor’s body, good business practices would dictate
identifying the donor (for example, (8) Information about the procedure that an OPO have written protocols that
name, address, date of birth, social for filing a complaint, meet the requirements of this section.
security number), organs and (when (9) Contact information in case the Therefore, there would be no additional
applicable) tissues and eyes recovered, individual(s) have questions, and burden.
date of the organ recovery, donor (10) A copy of the signed consent
management data, all test results, Section 486.348 Condition: Quality
form. Assessment and Performance
current hospital history, past medical If an OPO does not request consent to
and social history, pronouncement of Improvement (QAPI)
donation because a potential donor
depth, consent and next-of-kin consented to donation prior to his or her The ICRs under this section would
information. Donor records would have death in a manner that satisfied require the OPO to develop, implement,
to be maintained in a human readable applicable State law requirements, the and maintain a comprehensive, data-
and reproducible format for 5 years. OPO must provide information about driven quality assessment and
The OPO would have to maintain data the donation to the family of the performance improvement (QAPI)
in a format that can readily be potential donor, as requested. program designed to monitor and
continued by a successor OPO and We believe that all OPOs currently evaluate ongoing and overall
would have to provide to CMS copies of have policies regarding informed performance of all donation services,
all records, data, and software necessary consent, so there would basically be no including services provided under
to ensure uninterrupted service by a additional burden to them as the contract or arrangement
successor OPO. Records and data policies are usual and customary An OPO would have to establish in
subject to this requirement would business practice. (Some OPOs might writing a policy to address adverse
include records of individual donors, have to add some information, which events that occur during any phase of an
records on transplant candidates could minimally increase the time it organ donation case. The policy would
(including identifying data and data on takes to inform the individual(s) making have to address, at a minimum, the
immune system and other medical the donation decision.) process for identification, reporting,
indications) and procedural manuals analysis, and prevention of adverse
and other materials used in conducting Condition: Donor Evaluation and events.
OPO operations. Maintenance and Organ Placement and The OPO would have to report an
Although these ICRs would be subject Recovery (§ 486.344) adverse event to CMS and would have
to the PRA, we believe that all of them Under this section, the OPO must to provide to CMS written
reflect usual and customary business have an effective written protocol for documentation of the investigation and
practice and therefore have no added donor evaluation and management and analysis of the adverse event within 15
burden. organ placement and recovery. days of reporting the adverse event.
The burden associated with these Executive Order 12866 directs outcome and process performance
requirements would be the time agencies to assess all costs and benefits measures must rely on empirical
required to develop a QAPI and policy of available regulatory alternatives and, evidence, obtained through reasonable
regarding adverse events. It is also the if regulation is necessary, to select efforts, of organ donor potential and
time it would take to report the adverse regulatory approaches that maximize other related factors in each OPO’s
events to CMS. net benefits (including potential service area. The regulations must
We believe that, as part of its usual economic, environmental, public health include multiple outcome measures.
and customary business, a typical OPO and safety effects, distributive impacts, All 59 OPOs would be affected by the
would already have a QAPI and a policy and equity). A regulatory impact
requirements in this proposed rule to a
regarding reviewing adverse events. analysis (RIA) must be prepared for
greater or lesser degree. Many—
While we believe that each of the 58 major rules with economically
probably the majority—of OPOs have
OPOs already has a QAPI program in significant effects ($100 million or more
already put into practice many of the
place, the burden of reporting adverse annually). This proposed rule is an
economically significant rulemaking requirements we propose. However,
events is subject to the PRA. We OPO practices vary widely. Some
estimate that on average, CMS would under Executive Order 12866.
The RFA requires agencies to analyze requirements would impact many OPOs
receive 30 adverse event reports but have relatively little economic
annually. We have assumed that each options for regulatory relief of small
entities. For purposes of the RFA, small impact; others would have a larger
report would require 30 minutes to economic impact but would impact very
prepare, yielding a total annual burden entities include small businesses, non-
profit organizations, and government few OPOs. Thus, while we do not
of 15 hours. believe the requirements in this
If you comment on these information agencies. Most hospitals and most other
providers and suppliers are small proposed rule would have a substantial
collection and record keeping economic impact on a significant
requirements, please mail copies entities, either by non-profit status or by
having revenues of $6 million to $29 number of OPOs, we believe it is
directly to the following: desirable to inform the public of our
million in any one year. For purposes of
Centers for Medicare & Medicaid the RFA, all OPOs are considered to be projections of the likely effects of the
Services, Office of Strategic small entities. Individuals and States are final rule on OPOs. It is important to
Operations and Regulatory Affairs, not included in the definition of a small note that since OPOs are paid by the
Division of Regulations Development, entity. Medicare program on a cost basis, any
Attn.: Dawn Willinghan, CMS–3064– In addition, section 1102(b) of the Act additional costs that exceed an OPO’s
P, Room C5–14–03, 7500 Security requires us to prepare a regulatory annual revenues would be fully
Boulevard, Baltimore, MD 21244– impact analysis if a rule may have a reimbursed by the Medicare program.
1850. significant impact on the operations of Our projections are based largely on
Office of Information and Regulatory a substantial number of small rural data and information provided by the
Affairs, Office of Management and hospitals. This analysis must conform to CMS OPO Coordinators. Each
Budget, Room 10235, New Executive the provisions of section 603 of the Coordinator is responsible for the OPOs
Office Building, Washington, DC RFA. For the purposes of section located in one of the four CMS
20503, Attn: Christopher Martin, CMS 1102(b) of the Act, we define a small Consortia areas (Midwest, West, South,
Desk Officer. rural hospital as a hospital that is and Northeast). In some cases, no data
Comments submitted to OMB may located outside of a Metropolitan were available for one or more of the
also be e-mailed to the following Statistical Area and has fewer than 100 Consortia. However, OPO practices
address: e-mail: CMartin@omb.eop.gov; beds. typically vary by size and affiliation
or faxed to OMB at (202) 395–6974. Section 202 of the Unfunded
(hospital-based or independent), rather
Mandates Reform Act of 1995 also
IV. Response to Comments than by geographic location. Since all
requires that agencies assess anticipated
Because of the large number of items types of OPOs are represented within
costs and benefits before issuing any
of correspondence we normally receive each Consortium, we feel confident that
rule that may result in expenditure in
on Federal Register documents the practices and experiences of the
any one year by State, local or tribal
published for comment, we are not able OPOs within two or three of the
governments, in the aggregate, or by the
to acknowledge or respond to them Consortia are representative of all OPOs.
private sector, of $110 million.
individually. We will consider all Executive Order 13132 establishes Therefore, where data were not
comments we receive by the date and certain requirements that an agency available for all four Consortia, we
time specified in the DATES section of must meet when it promulgates a based our projections on data from
this preamble, and, if we proceed with proposed rule (and subsequent final fewer than four.
a subsequent document, we will rule) that imposes substantial direct The provisions of this proposed rule
respond to the major comments in the requirement costs on State and local would have a very limited economic
preamble to that document. governments, preempts State law, or impact on hospitals. It is expected that
otherwise has Federalism implications. improved OPO performance would
V. Regulatory Impact result from the rule and would increase
This rule does not impose substantial
We have examined the impacts of this direct requirement costs on State or organ donation and, therefore, the
proposed rule as required by Executive local governments and does not preempt number of organs available for
Order 12866 (September 1993, State law or have other Federalism transplantation. However, transplant
Regulatory Planning and Review) and implications. hospitals are reimbursed for their costs
the Regulatory Flexibility Act Section 701 of Pub. L. 106–505, which related to performing transplants, and
(RFA)(September 19, 1980 Pub. L. 96– was passed by Congress in 2000, donor hospitals are reimbursed by OPOs
354). Section 1102(b) of the Social requires us to promulgate regulations for the cost of maintaining potential
Security Act, the Unfunded Mandates with new OPO outcome measures and donors. Therefore, there are no negative
Reform Act of 1995 (Pub. L. 104–4) and to certify OPOs under those new economic impacts on hospitals that
Executive Order 13132. measures by January 1, 2002. The new would result from the rule.
Reason for This Regulation 1. Feasible Alternatives for Competition (HIV/AIDS). It is possible that cultural,
Among OPOs for Service Areas ethnic, or racial factors may affect organ
Approximately 70 people receive an donation rates. For example, if there is
organ transplant every day. However, Under this proposed rule, OPOs may
compete for an OPO’s service if the OPO a large immigrant population in a
another 16 die due to the lack of service area, there might be significant
transplantable organs (http:// has been de-certified by CMS. OPOs
may also compete for other OPOs’ cultural and language barriers to
organdonor.org). OPOs play a critical donation. Therefore, an OPO that
role in securing transplantable human service areas at the end of each 4-year
decided to compete for an open service
organs for seriously ill patients suffering re-certification cycle. OMB Circular A–
area might need to perform significant
from end-stage organ failure. In fact, 4 recommends that agencies explore
research and data analysis to determine
OPO performance is one of the most modifications of some or all of a
the barriers to increased organ donation
critical elements in the nation’s organ regulation’s attributes or provisions to
in a particular service area. Once this
transplantation system. An OPO that is identify appropriate alternatives. CMS
analysis was completed, the OPO’s staff
effective in procuring organs and believes that an important policy
would have to develop a detailed
delivering them safely to transplant decision in this rulemaking is the level
description of specific activities and
centers clearly will save more lives than of competition that would be allowed
interventions for increasing organ
an ineffective one. between the OPOs.
donation in the open service area.
Three levels of competition were
In passing the Organ Procurement Therefore, the development of an
considered. We have defined these
Organization Certification Act of 2000, acceptable bid would require the
alternatives, some of which are also diversion of staff resources from the
Pub. L. 106–505, Section 701, Congress discussed in the preamble, as:
made certain findings related to OPOs OPO’s normal operations.
a. Full Competition. Every OPO that
and the current re-certification process has met the re-certification criteria Full Competition Under Existing
for OPOs. These findings included: would be eligible to compete for another Regulations
a. Organ Procurement Organizations OPO’s service area. Under the current Conditions for
play an important role in increasing b. Limited Competition. Only those Coverage for OPOs, there was full
organ donation. OPOs that meet specific criteria would competition for each service area at the
b. The uncertainty that resulted from be allowed to compete for another end of each re-certification cycle (42
the Department of Health and Human OPO’s service area. CFR 486.316). OPOs that did not meet
Services’ current certification and c. Restricted Competition. The only the performance standards were de-
recertification process was actually competition allowed between OPOs certified and were not able to compete.
interfering with the OPOs’ effectiveness would be for the service area of an OPO Therefore, only OPOs that met the
in increasing the level of organ that had been de-certified by CMS. performance standards were permitted
donation. In this proposed rule, CMS has to compete for service areas.
attempted to strike a balance between Benefits of this approach: All other
c. The limitations noted in the DHHS’
the costs of competition in terms of things being equal, greater competition
recertification process included:
resource use and disruption of normal between OPOs should improve
i. Sole reliance on population-based business operations and the benefits of performance. If an OPO knows that it is
measures of performance that do not competition, namely the ability of in danger of losing its service area
take into consideration a particular competition to improve performance during the recertification process, it
population’s organ donation potential. and inspire innovative activity. should have an incentive to perform
ii. No allowance for other outcome Under this proposed rule, we would well. This incentive would likely cause
and process standards that may more select an OPO to replace an incumbent some OPOs to develop new, innovative
precisely reflect each OPO’s OPO if, in our assessment, the OPO practices.
performance and potential. could significantly increase organ Costs of this approach: As explained
iii. Lack of a process to appeal for donation within that service area. This above, the process of competing for a
recertification on either procedural or assessment would be based on the past service area involves the expenditure of
substantive grounds to the Secretary of performance of the competing OPOs and resources. However, there would be
DHHS. our assessment of the plans to increase little additional effort or resource
organ donation submitted by each expenditure for an incumbent OPO to
The Organ Procurement Organization competing OPO. These plans would, at compete for its own area. In addition,
Certification Act required that the a minimum: full competition is an adversarial
Secretary of DHHS promulgate a. Be based on the competing OPO’s process. This may adversely affect the
regulations that incorporate certain key experience in its own service area; current collaborative atmosphere that
requirements. Those requirements have b. Include an analysis of existing exists between the OPOs.
been incorporated into this proposed barriers to increasing organ donation in Finally, full competition provides an
rule. the open service area, both internal and opportunity for a minimally effective
Congress clearly wanted the Secretary external; and OPO to take over a failing OPO.
to establish a certification process that c. Contain a detailed description of Depending upon which OPOs competed
would decrease the uncertainty inherent specific activities and interventions for for a particular service area, however,
in the current CMS certification process increasing organ donation in the open there is no guarantee that a winning
and improve OPO performance. The service area. OPO would have more than the
goal was to increase organ donation and Many factors can affect organ minimum requirements to be re-
the number of transplantable organs donation rates. For example, a service certified, and thus the winning OPO
available for persons experiencing organ area might have a large elderly may be unable to improve donation in
failure. We believe that this proposed population, a low motor vehicle the service area. Therefore, we are not
rule establishes certification and accident rate, or a high incidence of proposing that OPO service areas be
competition processes that will meet Human Immunodeficiency Virus/ opened to competition from all OPOs.
those goals. Acquired Immune Deficiency Syndrome We have not yet quantitatively analyzed
the costs and benefits from this full collaborative atmosphere between some OPO for the service area based on its
competition approach, but we will do so OPOs may be adversely affected by success in meeting the process
for the final rule. However, we are limited competition. performance standards, as well as
requesting comment on this and other Thus, limited competition offers the submission of an acceptable plan to
approaches that allow for more intense advantage of having a better performing increase organ donation in the service.
competition than our preferred option. OPO take over the service area of an By requiring an OPO to have attained
incumbent OPO that is not performing the mean or greater in 4 out of 5
Limited Competition as well. It also offers the advantage of outcome performance measures in the
Under this option, all OPO service setting specific criteria to ensure that preceding re-certification cycle, we
areas would be open to competition as the better performing OPO has the would limit competition to OPOs that
under the full competition option; expertise to increase organ donation in had performed measurably better than
however, only those OPOs that met another service area. This should result the de-certified OPO. We believe such
specific criteria would be allowed to in increased organ donation in the OPOs would have the expertise to take
compete for another OPO’s service area. competed service area. Further, while over a poorly performing OPO’s service
The specific criteria used to designate limited competition has disadvantages, area and improve organ donation. Also,
which OPOs would be eligible to those disadvantages can be minimized. our preferred competition process
compete for another OPO’s service area would require fewer resources from the
would ensure that the competition was Restricted Competition
OPOs than full competition, ensure
limited to OPOs that had demonstrated Under this option, the only timely completion of the competitive
above average performance and that competition allowed between OPOs process, and minimize disruption to
OPOs permitted to compete for open would be for the service areas of OPOs operations in service areas.
service areas would be measurably that had been de-certified by CMS.
superior to the incumbent OPOs. However, the competition would still be 3. Quadrennial Certification
Benefits of this approach: The intent limited to OPOs that met specific Competition
of establishing competition between the criteria. The specific criteria would For the quadrennial certification
OPOs is to improve the overall need to ensure that the competing OPOs competition, our preferred option is also
performance of OPOs by allowing above were more than minimally performing limited competition with the following
average OPOs to take over the service OPOs. The intent would be to have an characteristics. We propose that for an
areas of poorly or marginally performing OPO that is performing measurably OPO to compete for an incumbent
OPOs, and to allow OPOs to bid for better than the de-certified OPO take OPO’s service area, the competing OPO
areas in which they have the potential over the service area. must have achieved at least 100 percent
to significantly outperform the Benefits of this approach: Limiting of the mean in 4 out of 5 outcome
incumbent OPO. The intent is not to competition in this way would restrict performance measures in the preceding
have OPOs competing against one competition to areas in which the re-certification cycle. In addition, the
another when there are only marginal expectation of significant improvement competing OPO’s conversion rate of
differences between the OPOs. in service could be met. In addition, potential donors to actual donors must
Therefore, we believe the specific fewer resources would be diverted from be at least 15 percentage points above
criteria would have to establish a organ procurement itself to the the incumbent OPO’s conversion rate
measurable differential. We have not yet competitive process. for the preceding re-certification cycle.
quantitatively analyzed the costs and Costs of this approach: Clearly, This option offers two clear
benefits from this limited competition restricted competition would severely advantages. First, the competition is
approach, but we will do so for the final limit the competition between OPOs. limited to at least average performing
rule. However, we are requesting Only service areas of de-certified OPOs OPOs because of the requirement that
comments on this and other approaches would be opened for competition. The an OPO must have achieved at least 100
that allow for more intense competition service areas of minimally performing percent of the mean in 4 out of 5
than our preferred option. OPOs (that is, OPOs whose performance outcome performance measures for the
Costs of this approach: Although was only slightly above the performance preceding re-certification cycle. Second,
limited competition would require of failing OPOs) would not be opened OPOs permitted to compete for open
fewer resources from OPOs, the for competition from OPOs that had service areas would be measurably
competitive activities would require performed measurably better. Therefore, superior to the incumbent OPOs due to
resources from OPOs that decide to restricted competition could not the requirement for an OPO to have a
compete for an open service area, improve organ donation in service areas conversion rate at least 15 percentage
especially a large amount of staff time. of minimally performing OPOs. points greater than the conversion rat of
For OPOs competing for another OPO’s the incumbent. These advantages
service area, these resources would be 2. Competition for De-Certified OPO’s
provide us with the assurance that a
in addition to those used to improve an Service Area
competing OPO would have the
OPO’s performance in its existing Our preferred option for competing expertise needed to increase organ
service area. service areas of de-certified OPOs is donation in an incumbent OPO’s service
Although fewer OPOs would be limited competition, as we feel this area.
involved with limited competition, it option best balances the benefits and This option would restrict the number
would still be an adversarial process. costs of the competitive process. of OPOs that would be eligible to
We anticipate that most OPOs would However, we are soliciting comments on compete for another OPO’s service area.
soon realize who their potential this conclusion. We propose that a de- However, we anticipate that there
competitors were and this could certified OPO would not be allowed to would be a substantial number of OPOs
adversely affect the current compete. The competition would be that would qualify to compete.
collaborative atmosphere that exists limited to OPOs that met 4 out of 5 of Under this option, it is possible that
between many of the OPOs. Although the outcome performance measures at or a superior performing OPO could
this effect would be to a much lesser above the mean in the preceding re- compete for the service area of an above
extent than with full competition, the certification cycle. We would select an average performing OPO. For example,
an OPO that achieved 120 percent of the also would provide us with the that is performing below average in its
mean in 4 out of 5 outcome performance assurance that the competing OPO had own service area would have the
measures could compete for the service the expertise to increase organ donation expertise needed to increase organ
area of an OPO that achieved 105 in the incumbent OPO’s service area. donation in another OPO’s service area,
percent of the mean in 4 out of 5 We are, however, concerned that this especially when the incumbent is
outcome performance measures. option would severely restrict performing poorly.
However, as long as the better- competition among OPOs because we In addition, the competitive process
performing OPO could significantly anticipate that few OPOs would meet itself causes disturbance in the
increase organ donation in the open 120 percent of the mean for 4 out of 5 operations of both the competing and
area, we believe it would be worthwhile performance measures. In addition, incumbent OPOs. Each must develop an
for the competition to take place. since most OPOs would probably be acceptable plan for the competition.
In determining the necessary interested only in competing for service This requires resources from both OPOs
differential that would be required to areas in their own geographical areas, that may have to be diverted from their
allow competition we had two goals. this could result in virtually no routine operations, as well as from their
The first was that we wanted the competition in certain areas of the efforts to increase organ donation in
differential to be large enough to assure country. their service areas. In order to justify the
us that the competing OPO had the disruption to OPO operations, there
Option 2
expertise to take over another service should be some assurance that the
area and increase organ donation; in As in the first option, option 2 would
competing OPO would be able to
other words, we wanted the differential require that to compete for an
increase organ donation in the
to reflect significant differences in incumbent OPO’s service area, the
incumbent OPO’s service area. With
performance. The second was that we competing OPO must have at least a 15
only a 15 percentage point difference
wanted to minimize the disturbance to percentage point conversion rate
and no requirement that the competing
routine OPO operations that is inherent advantage over the incumbent OPO for
the preceding re-certification cycle. The OPO be a good performer, we would not
in the competition process. feel confident that the competing OPO
We believe that our proposed 15 advantage of this option is that the
competing OPO would be required to would have the expertise needed to
percentage point differential strikes the
demonstrate that it had performed increase organ donation in the
balance needed to achieve both of these
measurably better than the incumbent incumbent OPO’s service area.
goals. It is large enough to demonstrate
OPO. While a variation of a few points Therefore, we believe that if the
that the competing OPO is performing
would not be a reliable indicator of an competing OPO is not at least an
measurably better than the incumbent
OPO’s superior quality, we believe a 15 average performer, the potential for a
OPO. It will also limit the competition
percentage point advantage in slight improvement in the service area
to OPOs that we can reasonably expect
conversion rate is a large enough would not justify this disruption to the
will be able to take over another service
difference to assure us that the service area.
territory and increase organ donation.
Congress clearly intended that a competing OPO’s performance is We also are requesting comments on
competitive process would reduce actually superior to the incumbent the option of restricted competition.
uncertainty and result in improved OPO’s performance. Under this option, the only competition
performance by OPOs. We believe that However, this option would not allowed between OPOs would be for the
such a competition would result in an require an OPO to have achieved a service areas of OPOs that had been de-
increase in organ donation and the certain level of performance in the certified by CMS. The competition
number of transplantable organs outcome performance measures during would be limited to OPOs that met 4 out
available for patients on the waiting list. the prior re-certification cycle. Thus, we of 5 performance measures at 100
We are specifically soliciting comment, are concerned that a 15 percentage point percent of the mean or greater. These
however, on modifications within our advantage is an insufficient criterion to specific criteria would ensure that the
chosen limited competition framework. determine whether or not a competing competing OPOs were more than
These options are discussed below. OPO has the expertise to perform minimally-performing OPOs and that
measurably better in the incumbent they were performing measurably better
Option 1 OPO’s service area because, under this than the de-certified OPO.
Under this option, an OPO competing option, an OPO that is a below average Under this option, fewer resources
for an open service area must have performer could compete for the service would be diverted from organ
achieved at least 120 percent of the area of a poorly performing OPO. For procurement itself to the competitive
mean in 4 out of 5 outcome performance example, an OPO that achieved 90 process, and collaboration among OPOs
measures for the preceding re- percent of the mean in 4 out of 5 would not be disturbed. However, this
certification cycle. In addition, the outcome performance measures would option would not allow for competition
competing OPO must have at least a 15 be permitted to compete for a service for the service areas of OPOs that only
percentage point conversion rate area in which the incumbent OPO barely met the qualifications for re-
advantage over the incumbent OPO. achieved 75 percent of the mean in 4 certification.
That is, the competing OPO’s out of 5 outcome performance measures. Cost-Effectiveness and Cost-Benefit
conversion rate of potential donors to While the 15 percentage point Analysis of Preferred Option
actual donors (the first of the five difference indicates that the competing
performance measures) must be 15 OPO is measurably superior to the Our proposed criteria for selecting a
percentage points higher than the incumbent OPO, it does not require that competing OPO are success in meeting
incumbent OPO’s conversion rate. the OPO is at a minimum an average the process performance measures
This option would ensure that the performer. during the prior re-certification cycle
competing OPO had above average We are concerned about an OPO with and an acceptable plan to increase organ
performance and that its performance below average performance competing donation in the open service area. The
was measurably superior to the for the service area of another OPO minimum requirements for an
performance of the incumbent OPO. It because we do not believe that a OPO acceptable plan would be:
• Demonstrate the competing OPO’s also require OPOs to have bylaws to (approximately $50 per hour), it would
experience in its own service area; address potential conflicts of interest, cost an OPO $400 to develop a set of
• Include an analysis of existing length of terms, and criteria for selection bylaws, for a total of $25,600 to develop
barriers to increasing organ donation in and removal of board members. It 64 sets of bylaws. We expect that most,
the open service area, both internal and requires an individual or a governing if not all, OPOs currently have an
external; and body to have full legal authority and individual or governing body legally
• Provide a detailed description of responsibility for management and responsible for management and
specific activities and interventions for provision of all OPO services, including provision of OPO services. Therefore,
increasing organ donation in the open development and implementation of we do not expect that there would be a
service area. policies and procedures for cost to OPOs to implement this
We feel that it would take a administration of the OPO. provision of the regulation.
competing OPO approximately 16 hours The economic impact to add a tissue It is extremely difficult to quantify the
to develop an acceptable plan. A bank member to an OPO board would be costs for OPOs of meeting the
competing OPO would need to assess negligible because OPOs generally do requirements for human resources. The
the incumbent OPO’s service area, not pay board members for their human resources condition would
determine the reasons for or the factors services. The economic impact on OPOs require every OPO to have a medical
that affected the incumbent’s that do not have bylaws for their boards director, although it would not specify
performance, develop an analysis of the addressing conflicts of interest, length of that the medical director must be full
existing internal and external barriers to terms, and criteria for selection and time. We believe all OPOs have medical
increasing organ donation in the service removal of board members would be the directors, because the OPTN states that
area, determine the specific activities cost of developing such bylaws. The OPOs must have medical directors who
and interventions the competing OPO extent of the impact would depend on are licensed physicians and who are
can perform to increase organ donation, the process used to develop the bylaws. responsible for medical and clinical
and finally, prepare and submit the For example, at some OPOs, it is likely activities of the OPO. However, our
plan. an executive committee of the board proposal would require the medical
CMS has not yet fully analyzed the would develop bylaws for approval by director to be involved in the day-to-day
costs and benefits of the alternatives the entire board. This process would operations of the OPO because he or she
presented above. We expect that the result in little or no cost to the OPO would be responsible for
costs per bid assumed in this analysis because the bylaws would be developed implementation of protocols for donor
will be roughly linear as the number of by unpaid board members. However, evaluation and management and organ
bids increases or decreases based on the other OPOs might include the OPO placement and recovery, as well as
allowed level of competition; however, director in the development of the assisting in management of donor cases
the costs of preparing a bid may depend bylaws. In this case, there would be a if the surgeon on call were unavailable.
on local variation in labor rates. We cost to the OPO, based on the number We believe that nearly all OPOs have
expect that the benefits of competition of hours needed to develop the bylaws a full-time medical director or one or
are not linear; under limited and the director’s salary. We do not more part-time directors whose
competition, CMS would limit bids only expect that development of bylaws responsibilities include implementation
to those situations where we expect that would take more than a few hours, since of protocols for donor evaluation and
competition will be especially information and advice regarding management and organ placement and
successful in improving performance. development of bylaws would be recovery and who assist in the
We expect that the marginal returns to available from OPOs that already have management of donor cases if the
competition are greater for the more bylaws in place for their boards. surgeon on call is unavailable. These
restrictive limited competition options, It appears that about 70 percent of OPOs would already meet the
and that the marginal returns to OPOs do not have bylaws for their requirements of the proposed rule. In
competition diminish as the options boards addressing conflicts of interest, fact, we believe that every OPO in two
become more permissive. CMS plans to and approximately 22 percent do not of the CMS Consortia already fully meet
fully analyze the costs and the benefits have bylaws addressing length of terms this proposed requirement. However, in
of the competitive process in the final and criteria for selection and removal of a very small number of OPOs, medical
rule. board members. This would mean that directors are not actively engaged in
Under the statute and current OPO approximately 18 OPOs would need to OPO operations; their participation may
regulations, OPOs must be members of develop bylaws addressing conflicts of be limited to consulting and attending
and abide by the rules of the OPTN (as interest, and approximately 46 would board meetings.
defined in § 486.320); therefore, there is need to develop bylaws addressing It is difficult to quantify the cost to
no additional burden associated with length of terms and criteria for selection these few OPOs of meeting the proposed
this condition. and removal of board members. Thus, requirement because the cost to an
Current OPO regulations require under this proposed rule, OPOs would individual OPO would be dependent on
OPOs to have a board of directors or an need to write 64 sets of bylaws for their whether the OPO needed to hire a full-
advisory board with a specific boards of directors. time medical director, hire one or more
membership composition. The In one CMS Consortium, OPO additional part-time medical directors,
condition for administration and Directors’ salaries range from or increase the hours of an existing
governing body in this proposed rule approximately $80,000 to more than medical director, and to what extent.
might require an OPO to add one $130,000. To estimate the economic Furthermore, salaries of medical
additional member to its board. If the impact, we assumed that all OPOs directors vary widely. Some local
tissue banks in the OPO’s service area would choose to have their directors transplant surgeons who serve as part-
currently are represented on the board participate in developing bylaws for time OPO medical directors do not
by the OPO’s own tissue bank, the OPO their boards, and that the development accept a salary for the services they
would be required to add a member of each set of bylaws would take 8 hours provide to the OPO; other part-time
from a tissue bank that is not affiliated of an OPO director’s time. If every medical directors are paid up to
with the OPO. This condition would director made $105,000 per year $100,000 per year. A full-time medical
director may be paid less than $100,000 medical technicians had a median policy to address potential conflicts of
or as much as $250,000 annually. annual income of $24,460. interest for its director, medical director,
To estimate the economic impact of We estimate that 10 percent of OPOs senior management, and procurement
the medical director requirement, we (6 OPOs) would need to add one coordinators. Although we expect that
assumed that 10 percent of OPOs (6 additional professional staff person and most OPOs have written policies in
OPOs) would need to hire a part-time or 5 percent (3 OPOs) would need to hire place, we know that some OPOs do not.
full-time medical director or increase 2 additional staff, for a total 12 If an OPO had to develop such a policy,
the hours of an existing director and additional staff. (This estimate includes it is likely it would be developed by the
that, on average, each of these OPOs additional staff needed to meet all OPO director and would take
would need a medical director for an proposed requirements except the QAPI approximately 8 hours. If the director is
additional 20 hours per week. If the requirements, which are discussed later paid $105,000 annually (approximately
OPOs reimbursed the medical directors in this preamble.) If each staff person $50 per hour), the cost to the OPO
based on a rate of $125,000 annually, it was paid $45,000, the total economic would be approximately $400. If 25
would cost each OPO $62,500, and the impact would be $540,000. percent of OPOs (approximately 15
total economic impact would be The human resources condition also OPOs) needed to develop such bylaws,
$375,000. would require OPOs to provide the the total economic impact would be
We are also proposing to require an education, training, and supervision to $6000.
their staffs necessary to furnish required The human resources condition also
OPO to maintain sufficient staff to carry
services. We have found that OPOs would require OPOs to maintain
on essential OPO activities, such as
generally offer three types of staff credentialing records for physicians and
answering hospital referral calls in a
education and training, depending upon other practitioners who routinely
timely manner and providing
the size and resources of the OPO: (1) recover organs in donor hospitals with
information and support to potential
On-the-job-training; (2) in-depth which the OPO has agreements and
donor families. Most OPOs have
training provided within the OPO, ensure that all physicians and other
sufficient staffing to carry on essential
sometimes using a modular training practitioners who recover organs in
activities; to the extent that they do not,
structure; and/or (3) classroom training hospitals are qualified and trained. We
this rule would require them to hire
that, in some cases, leads to certification have been told by OPOs that most, if not
additional staff. However, the impact on in procurement and transplantation. all, OPOs have some type of process to
individual OPOs would vary, depending Costs for training vary widely; ensure that physicians and other
upon their situations. For example, all however, we have found that good staff practitioners who recover organs are
OPOs in one CMS Consortium appear to training need not be expensive. OPOs qualified.
have sufficient staff to carry on essential provide no-cost training to each other, In most cases, organs are recovered by
activities. In another Consortium, all but in the form of on-site training sessions transplant surgeons from the hospital
two OPOs have sufficient staff. These in hospital development, as well as that will perform the transplant or by
two OPOs are adding staff based on opportunities for staff details and physicians or technicians employed by
comparative data from successful OPOs ‘‘shadowing’’ of staff at high-performing or under contract with OPOs. OPOs that
and from the AOPO Annual Report and OPOs. UNOS Regional Forums, which do not have a process to ensure that
expect to be staffed fully by mid-2004. are held once or twice per year in the physicians and other practitioners are
However, in a third Consortium, slightly 11 UNOS Regions, provide qualified and trained would incur some
more than half of the OPOs most likely opportunities for staff training at a low costs to put a process into place. An
would need one or two procurement cost (for example, $75 per day). Since OPO would incur a cost for the staff
coordinators or other professionals in the training is held within the UNOS time needed to request and review
order to have sufficient staff. Region, travel costs are kept to a credentialing records for transplant
Most staff carrying on what would be minimum. Two OPOs in one of the CMS surgeons and to request and review
considered ‘‘essential’’ activities (for Regional Consortia have elected to use documentation of the qualifications of
example, procurement, hospital modular training with demonstration other recovery personnel.
development, and screening of referral and examination required to move to We estimate that requesting and
calls) have a medical background. the next level. Training will be provided reviewing a record would take no more
Procurement coordinators are usually to all new and existing OPO than 15 minutes. There are
registered nurses (RNs), but sometimes professional staff; the cost is estimated approximately 270 hospitals in the
they are social workers. In 2000, the at $5000 per OPO. Some OPOs send United States with transplant programs.
median annual income of an RN was their procurement coordinators for Thus, each of the 59 OPOs has, on
$44,840, and the median annual income training provided by the North average, about five transplant hospitals
of medical and public health social American Transplant Coordinators in its service area. If each hospital has
workers was $40,020. We have observed Organization, which costs 20 surgeons who recover organs, an
that procurement coordinators generally approximately $1000 to $1500 per OPO would have to request and review
earn about $40,000 to $45,000 to start. coordinator. approximately 100 records. Presuming
Hospital development staff are If we estimate that 25 percent of OPOs this activity was performed by an OPO
sometimes RNs and sometimes (approximately 15 OPOs) would need to medical director making $125,000 per
individuals with public relations provide additional education and year ($60 per hour), the cost to the OPO
backgrounds. In 2000, public relations training to their professional staff in for the medical director to spend 25
managers had a median annual income order to meet the requirements of the hours reviewing 100 records would be
of $54,540. Sometimes OPOs’ hospital proposed rule, and all 15 chose to use $1500. If we estimate that 10 percent of
development and procurement staffs in-depth modular training within the OPOs (approximately 6 OPOs) will need
screen referral calls; however, OPOs OPO, the cost to each OPO would be to perform this activity, the total cost
may hire other individuals to screen approximately $5,000, and the total cost would be $9000.
calls, such as medical and nursing for all 15 OPOs would be $75,000. We have not assigned a cost for an
students or emergency medical The human resources condition OPO to request and review records for
technicians. In 2000, emergency would require an OPO to have a written physicians or other recovery personnel
who work for or are under contract to requirement, as data would be requested we propose requiring OPOs to address
the OPO because we assume the OPO on an as-needed basis, we believe that the responsibilities of both the OPO and
would perform those activities in the almost any OPO data needed by us or the hospital in implementing § 482.45
normal course of business. Likewise, we other agencies within the Department and § 485.643 and include definitions
have not assigned a cost for activities could be obtained from the OPTN or the for the terms ‘‘imminent death’’ and
associated with ensuring the SRTR. We are including this provision ‘‘timely referral.’’
qualifications and training of physicians only to give us and other agencies the Many OPOs would be required to
and other recovery personnel from flexibility to request data from OPOs in rewrite their agreements; however, we
outside an OPO’s service area. The time the event that needed data cannot be expect OPOs would develop a standard
needed to verify qualifications and obtained expeditiously from the OPTN agreement that addresses OPO and
training of these recovery personnel, or the SRTR. We would not request data hospital responsibilities and defines
who only occasionally recover organs in from OPOs if the data were readily ‘‘imminent death’’ and ‘‘timely death’’
an OPO’s service area, would be available from other sources. and would ask each of their hospitals to
minimal and could be accomplished by However, we can quantify the impact sign the standard agreement. We
contacting a transplant hospital to on OPOs of reporting the four hospital- estimate that it would take an attorney
confirm that a surgeon who will recover specific data elements they currently 8 hours to draft a new standard
an organ at one of the OPO’s hospitals report voluntarily to the OPTN (that is, agreement that the OPO could present to
is credentialed and has privileges at the referrals, medically suitable potential each hospital. The average hourly wage
transplant hospital. donors, consents, and donors). All 59 for an attorney is $40; therefore, the cost
The current OPO regulations require OPOs have the capability of reporting to the OPO would be $320. The total
OPOs to maintain donor records with data to the OPTN electronically. HRSA cost for all 59 OPOs to have a new
specific data elements, although there is estimates that reporting the four data standard agreement drafted would be
no requirement for how long the records elements takes OPOs about 1 hour per $18,880.
must be kept. The proposed information month. If the data are entered by a data The average OPO has approximately
management condition would require coordinator earning $40,000 per year 100 hospitals in its service area. Based
OPOs to include specific data elements (approximately $19.25 per hour), the on past experience, we expect that
in their records and maintain their cost to the OPO would be approximately between 50 percent and 67 percent of
records for 7 years. We do not anticipate $231 annually, for a total cost for all 59 the hospitals in an OPO’s service area
a significant burden associated with this OPOs of approximately $13,629. would sign the standard agreement with
requirement because, the final rule At the recommendation of the OIG, no changes. With few exceptions, the
governing the operation of the OPTN we are including a requirement for remainder of the hospitals would sign
state that OPOs must maintain donor OPOs to report hospital-specific the agreements after a minimal amount
records for 7 years; thus, we expect donation data to the public. More than of negotiation. If 50 hospitals (50
OPOs already meet the proposed 90 percent of OPOs publish newsletters percent of the 100 hospitals in an OPO’s
requirement. and annual reports to inform the public service area) requested changes in the
The condition for reporting of data of their activities, and, most likely, agreement before signing, and it took the
specifies that an OPO must provide OPOs will report the hospital data in OPO’s attorney 2 hours per agreement to
organ donation and transplantation data their newsletters and annual reports at make the changes, it would cost the
as requested by the OPTN, the SRTR, very little additional cost. Since all 59 average OPO $4000. The total cost for
and transplant hospitals. Additionally, OPOs maintain Internet sites, they could all OPOs to make changes in their
the OPO would be required to provide include the hospital data on their sites agreements with hospitals would be
data and other information directly to at a negligible cost. $236,000.
the Department as requested by the There are provisions in the proposed The condition also would require
Secretary. The current regulations condition for OPOs’ relationships with OPOs to offer annual designated
require only that OPOs report five hospitals that do not appear in our requestor training to hospital and
performance data elements to us current regulations for OPOs. First, the critical access hospital staffs. Although
annually and ‘‘maintain and make condition would require an OPO to have the hospital and critical access hospital
available to CMS, the Comptroller written agreements with 95 percent of CoPs give OPOs the responsibility for
General, or their designees data that the hospitals and critical access offering or approving designated
show the number of organs procured hospitals in the OPO’s service area requestor training for hospitals, very few
and transplanted.’’ (unless a hospital has a waiver to work OPOs have actually provided a
Although it appears this requirement with another OPO) that have both a significant amount of training to their
has the potential to add a significant ventilator and an operating room. We hospitals. In fact, an August 2000 OIG
new reporting burden, OPOs already expect that OPOs already have report (Medicare Conditions of
report a large amount of data to the agreements with all Medicare and Participation for Organ Donation: An
OPTN (which, in turn, provides the data Medicaid hospitals in their service areas Early Assessment of the New Donation
to the SRTR for analysis). For example, (unless a hospital in the service area has Rule) criticized OPOs for not providing
the cadaver donor registration form that a waiver to work with another OPO) more designated requestor training.
OPOs are required to complete for each because the hospital and critical access Therefore, complying with this
donor contains more than 300 data hospital CoPs for organ, tissue, and eye proposed requirement may add some
elements. Further, regulations governing procurement (see 42 CFR 482.45 and costs for an OPO that has provided little
the operation of the OPTN at 42 CFR 485.643), require Medicare and or no designated requestor training if
121.11(b)(2) require OPOs, as specified Medicaid participating hospitals and hospitals and critical access hospitals in
by the Secretary, to submit data to the critical access hospitals to have an its service area respond positively to the
OPTN. Thus, most information needed agreement with an OPO. We have found OPO’s offer to provide training.
by the OPTN, the SRTR or the Secretary that most agreements between OPOs However, we do not anticipate a
would already be reported by OPOs. and hospitals are ‘‘generic’’ in nature significant economic impact because
Although it is impossible to quantify and do not specify the OPO and hospital most hospitals cannot spare staff to
the impact of the data reporting roles in the donation process. However, attend training in the entire consent
process and prefer to have their OPO arrangements with an OPO would toward developing a comprehensive
handle most of the consent process. request an arrangement. QAPI program.
Additionally, although many hospital If an OPO and tissue bank elected to We believe it is likely that
staff act as designated requestors in a have a written agreement, we would approximately 20 percent of the 59
supportive or collaborative role, we expect that the cost to the OPO of OPOs (12 OPOs) would need 1⁄2 of a
expect training for the supportive or preparing the written agreement and full-time equivalent (FTE) position to
collaborative role to be significantly less making any changes negotiated with the bring their QAPI programs into
extensive (and therefore less costly) tissue bank would be similar to the costs compliance with the requirement, and
than training hospital staff for a of preparing and making changes to a 15 percent (9 OPOs) would need 1 FTE.
requestor role. For example, complete written agreement between an OPO and An OPO would be likely to use an
designated requestor training might last a hospital (that is, a one-time cost to the experienced individual from its hospital
for 4 to 8 hours, whereas, supporter or OPO of $320 for preparing an development or procurement staff, and
collaborator training might last for 2 agreement, and an additional cost of $80 we estimate that the individual would
hours or less. Designated requestor to make changes). However, unlike be paid approximately $50,000
training also may be provided through hospital agreements which could be annually. Thus, the cost to each of the
the use of a videotape. At least one OPO standardized, we would assume that 12 OPOs that would need to add 1⁄2 of
provides designated requestor training OPO/tissue bank agreements would be an FTE would be approximately $25,000
over the Internet. individualized, since it is unlikely that per year, and the cost to each of the 9
Generally OPO hospital development more than one tissue bank in an OPO’s OPOs that would need to add a full FTE
staff (who are likely to earn about service area would request an would be $50,000 per year, for a total
$45,000 per year) provide designated arrangement. Therefore, the total cost of cost of $750,000.
requestor training in hospitals. If the preparing each agreement and making In addition, the proposed requirement
average training session lasts 4 hours changes would be $400, and the cost of for QAPI would require an OPO to
and is given at a hospital located 20 preparing agreements with 15 tissue perform death record reviews in every
miles from the OPO, the total cost of a banks would be $6000. Medicare and Medicaid hospital in its
service area that has 150 or more beds
training session (including salaries for For several reasons, we do not believe
or a level I or level II trauma center,
two trainers for preparation, travel, and the proposed requirement to have a
with the exception of rehabilitation or
training time; mileage; and preparing QAPI program will have a significant psychiatric hospitals. Based on our
and printing training packets) would be impact on a large number of OPOs. experience, all OPOs routinely perform
approximately $300. Based on our First, as stated earlier in this preamble, death record reviews in hospitals they
experience, we expect that nationwide, most OPOs have a QAPI-type program consider to have significant donor
approximately 75 hospitals might (although not all programs are potential, but an OPO’s definition of
request designated requestor training. sufficiently comprehensive to meet the ‘‘significant donor potential’’ may not
Thus, the total economic impact would requirements of the proposed encompass as many hospitals as the
be approximately $22,500, with an regulation). Second, AOPO is actively requirement in the proposed rule. To
average of less than $400 per OPO. encouraging all OPOs to expand and the extent that it does not, the OPO
An OPO would be required to have improve their programs; in fact, AOPO might need to increase staff hours to
arrangements to cooperate with tissue recently added the development of a perform the additional death record
banks that have agreements with quality improvement program to their reviews. We estimate that
hospitals with which the OPO has requirements for AOPO accreditation, approximately 20 percent of OPOs (12
agreements. OPOs would be required to although the new requirements will be OPOs) may need to add 1⁄2 of an FTE in
cooperate in screening and referring phased in over 3 years. Third, in order to expand the number of hospitals
potential tissue donors, obtaining November 2001, AOPO surveyed OPOs in which it performs death record
informed consent on behalf of tissue to assess its programs and found that 43 reviews. It is likely the death record
banks, and in the retrieval, processing, percent of the 35 OPOs that responded reviews would be performed by RNs
preservation, storage, and distribution of had designated a staff person whose earning approximately $45,000 per year,
tissues. Most OPOs already have primary job responsibility was thus the cost to an OPO of adding 1⁄2 of
arrangements with the tissue banks in coordinating and monitoring quality an FTE to perform death record reviews
their service areas that address such improvement. We have reason to believe would be approximately $22,500. The
issues as screening and referral of tissue this percentage would be much higher total economic impact for all 12 OPOs
donors. We are proposing this if the survey were performed today. would be $270,000.
requirement to address situations in Since AOPO conducted their survey, the The proposed rule requires that an
which an OPO has refused to have an majority of the OPO community has OPO’s QAPI program include a written
arrangement with the tissue bank embraced continuous quality policy to address adverse events. We
selected by the hospital. improvement and taken steps to estimate that about 90 percent of OPOs
There are approximately 300 tissue integrate quality improvement into their (53 OPOs ) would need to develop a
banks in the United States (166 core business structure. written adverse event policy and that
conventional tissue banks and 134 eye Additionally, there are numerous low- development of the policy would
banks) or approximately 5 tissue banks cost or no-cost resources available to require 40 staff hours. We expect that
per OPO service. In many service areas, OPOs to develop QAPI programs, the policy would be developed by
the OPO owns or is affiliated with one including the Breakthrough professional staff, including
of the tissue banks. In nearly all service Collaborative, assistance from CMS OPO procurement coordinators, medical
areas, OPOs have arrangements with all Coordinators, and the AOPO Quality directors, and OPO directors. We
tissue banks that have agreements with Council. While we know that some estimated an annual salary of $45,000
the hospitals in the service area. Based OPOs will be impacted by the proposed (approximately $22 per hour) for a
on our experience, we would expect QAPI requirement, we do not expect the procurement coordinator, $125,000
that fewer than 5 percent of tissue banks impact to be significant because, at this (approximately $60 per hour) for a
(15 tissue banks) that do not have time, all OPOs appear to be working medical director, and $105,000
(approximately $50 per hour) for an programs in its service area. If it took an Although many in the donation organ
OPO director, and we averaged the three OPO medical director 10 hours to community believe that little can be
hourly rates to arrive at a cost of $44 per develop a protocol with a transplant done to increase the number of deceased
staff hour to develop an adverse event center and the medical director earned donors, we would note that in 1998, the
policy. Therefore, the cost to one OPO a salary of $125,000 annually year in which the hospital CoP (see
of developing an adverse event policy (approximately $60 per hour), it would § 482.45) went into effect, organ
would be $1760 for 40 hours of work. cost an OPO $600 for development of a donation increased by nearly 6 percent.
The total cost to all 53 OPOs that would single protocol and a total of $8400 to Therefore, we estimate that by
need to develop such policies would be develop 14 protocols. (We assume that increasing OPOs’ efficiency and
$93,280. each protocol would be individualized.) adherence to continuous quality
The condition for requesting consent If we assume that 70 percent of the 59 improvement measures, the provisions
will have little impact on OPOs. We OPOs (41 OPOs) needed to develop of this proposed rule could increase the
believe all OPOs have policies for protocols, the total economic impact number of organ donors by as much as
obtaining informed consent and provide would be $344,400. 3 percent per year, resulting in an
training to their staffs in the informed We foresee little economic impact additional 180 donors in the
consent process. Under the proposed from the proposed requirements in the regulation’s first year. Based on 2000
conditions, some OPOs may have to condition for organ preparation and data for the number of organs
broaden their informed consent policies, transport. We believe nearly all OPOs transplanted per donor (2.87), a 3
but there will be little resultant follow appropriate standards of practice percent increase would result in
economic impact. for testing and tissue typing of organs. approximately 517 additional
The proposed rule would require Developing and following a protocol for transplants in the first year after
OPOs to have written protocols for packaging, labeling, handling and implementation of the regulation.
donor evaluation and management and shipping of organs can be done at very Transplants are performed both to
organ placement and recovery that meet little added cost. For example, the cost save lives and to improve the quality of
current standards of practice and are of additional supplies for labeling inner recipients’ lives. For end-stage renal
designed to maximize organ quality and and outer packaging of organs with the disease patients, dialysis is an
optimize the number of donors and the donor blood type would be negligible. alternative to transplantation for
number of organs recovered and Our estimates of the economic impact extended periods of time. Nevertheless,
transplanted per donor. Based on our on OPOs to meet the requirements in physical health while on dialysis is
experience, all OPOs have written this proposed rule are as follows. significantly impaired, and dialysis
protocols for donor evaluation and • $25,600 to develop bylaws for OPO imposes major stresses and substantial
management and organ placement and boards inconveniences in carrying out normal
recovery. The OPTN also has model • $375,000 annually for medical activities. Therefore, while for most
protocols OPOs can follow for director salaries patients, kidney transplantation is not
evaluation and management of potential • $540,000 annually for additional necessary for survival, it significantly
donors. Some OPOs might need to staff to meet human resources improves the quality of the transplant
update or change their protocols requirements recipient’s life. For all other organs, a
somewhat to meet the proposed • $75,000 initial cost for staff training transplant is, in most cases, necessary
requirements, but we believe the cost to • $6,000 to develop bylaws for OPO for survival.
individual OPOs would be negligible. directors and other management staff Of the 17,219 transplants from
The condition for donor evaluation • $9,000 to develop credentialing deceased donors performed in 2000,
and management and organ placement records for recovery staff slightly less than half (46.7 percent), or
and recovery requires the medical • $13,629 annually to report data 8,040, were kidney transplants. Thus,
director from the OPO to be responsible • $18,880 to develop hospital we estimate that in the first year, this
for ensuring that the OPO has written agreements regulation could result in approximately
protocols for donor evaluation and • $22,500 for designated requestor 241 (46.7 percent of 517 transplants)
management and for ensuring the training lives vastly improved by kidney
implementation of the protocols for • $6,000 to develop arrangements transplants and 276 (53.3 percent of
each donor. Costs related to hiring or with tissue banks 517) lives both vastly improved and
increasing the hours of a medical • $750,000 annually for QAPI staff prolonged by transplantation of other
director are discussed as part of the • $270,000 to perform death record major organs.
human resources condition. reviews The following reasoning was used to
This condition also requires OPOs to • $93,280 to develop an adverse event construct an estimate of the benefits of
establish protocols in collaboration with policy this proposed rule. It is common, in cost
transplant programs that define the roles • $344,400 to develop protocols with benefit analysis, to use a concept termed
and responsibilities of the OPO and the transplant centers. ‘‘value of a statistical life’’ (VSL) to
transplant program. It appears that all estimate in monetary terms the benefits
OPOs have some type of agreement or Summary of Direct Cost from lives saved. Estimates of this value
arrangement with the transplant centers Therefore, the first-year economic can be derived from information on the
in their service areas, but often these impact would be $2,549,289, and the preferences of individuals for reduction
agreements or arrangements are average first-year cost to each of the 59 in the risk of death, and their
informal in nature. Based on our OPOs would be $43,208. willingness to pay for those reductions.
experience, we expect that developing a For purposes of our cost benefit
protocol with a transplant center as Benefits analysis, we have used a VSL of
required under the proposed rule would The primary economic impact of this $5,000,000. Applying this VSL, the
take approximately 10 hours. There are proposed rule would lie with its social benefit from 276 non-renal
approximately 824 transplant programs potential to increase organ donation. transplants would be $1,380,000,000.
in the U.S.; therefore, each of the 59 However, it is nearly impossible to Kidney transplantation costs are offset
OPOs has approximately 14 transplant predict what that impact will be. by reductions in other medical costs
over time, primarily dialysis costs. Medicare did not begin paying for United States, for a total, with intestinal
Since private payers generally base their intestinal transplants until April 2001. transplants, of 1,132 transplants.
payments on Medicare payment rates, However, the number was small—only Therefore, the figures below
we used data on Medicare payments to 36 intestine transplants were performed underestimate the economic impact of a
estimate the total cost to the economy of in the United States in 1999. In 3 percent increase in the number of
the additional non-renal transplants that addition, the chart does not include transplants by approximately 14 percent
would be performed. Below, based on heart-lung, kidney-pancreas, and other (1,132 is approximately 14 percent of
2000 payment data, are 1-year estimated multi-organ transplants, since complete the 15,670 heart, liver, lung, pancreas,
costs to the Medicare program resulting data are not available for these and kidney transplants performed in
from a 3 percent increase in non-renal transplants. In 1999, there were 48
1999).
organ transplants. Costs for intestinal heart-lung, 928 kidney-pancreas, and
transplants were not available as 120 other multi-organ transplants in the
ESTIMATED ONE-YEAR COSTS OF NON-RENAL TRANSPLANTS

Cost (inpatient
Organ type 3 percent increase hospital & physi-
cian)
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 not prepared a formal uncertainty For the reasons set forth in the
providing post-transplant care, we analysis for this proposed rule; preamble, the Centers for Medicare &
turned to the Milliman and Robertson 5- however, we will prepare a formal Medicaid Services proposes to amend
year cost estimates that were used by us uncertainty analysis for the final rule. 42 CFR chapter IV as set forth below:
in the regulation for Medicare and Possible sources of uncertainty are the
Medicaid hospitals, Identification of actual percentage improvement in organ PART 413—PRINCIPLES OF
Potential Organ, Tissue, and Eye donation expected by this rule and REASONABLE COST
Donors. They are as follows: heart, alternatives; the number of expected REIMBURSEMENT; PAYMENT FOR
$317,000; liver, $394,000; lung, total donations, which varies somewhat END-STAGE RENAL DISEASE
$312,000; and pancreas, $149,000. year to year; the cost of competitive SERVICES; PROSPECTIVELY
However, note that in recent years, bids; the expected number of OPOs de- DETERMINED PAYMENT RATES FOR
inpatient hospital stays for heart certified, and the number of OPOs SKILLED NURSING FACILITIES
transplant patients have increased eligible to compete based on their
considerably (with a resultant rise in performance measures. We request 1. The authority citation for part 413
costs), whereas inpatient stays for liver comments on other potential sources of is revised to read as follows:
transplant patients have decreased uncertainty. Authority: Secs. 1102, 1138(b), 1812(d),
considerably. Nevertheless, as Milliman In accordance with the provisions of 1814(b), 1815, 1833(a), (i), and (n), 1871,
and Robertson estimates are the only Executive Order 12866, this regulation 1881, 1883, and 1886 of the Social Security
transplant data available on post- was reviewed by the Office of Act (42 U.S.C. 1302, 1395d(d), 1395f(b),
1395g, 1395l(a), (i), and (n), 1395hh, 1395rr,
transplant costs, we used their Management and Budget. 1395tt, 1395ww, and 1395(x)(v)).
estimates.
Based on their estimates, the 5-year List of Subjects
§ 413.200 [Amended]
costs would be as shown on the 42 CFR Part 413
following chart. 2. Section 413.200(f) is amended by
Health facilities, Kidney diseases, removing the phrase ‘‘part 485, subpart
Organ type 5–year cost Medicare, Puerto Rico, Reporting and D’’ and by adding ‘‘part 486, subpart D’’
recordkeeping requirements. in its place.
Heart ..................................... $20,922,000
Liver ...................................... 53,978,000
42 CFR Part 441 § 413.202 [Amended]
Lung ...................................... 8,736,000 Family planning, Grant programs- 3. Section 413.202 is amended by
Pancreas ............................... 1,937,000 health, Infants and children, Medicaid, removing the phrase ‘‘as defined in
Penalties, Reporting and recordkeeping § 435.302 of this chapter’’ and by adding
Total ............................... 85,573,000
requirements. ‘‘as defined in § 486.302 of this chapter’’
Formal Uncertainty Analysis 42 CFR Part 486 in its place.
As discussed elsewhere in this Health professionals, Medicare, Organ PART 441—SERVICES:

preamble, our best estimate of the procurement, X-rays. REQUIREMENTS AND LIMITS
impact of this proposed rule is a benefit APPLICABLE TO SPECIFIC SERVICES
of more than $1 billion each year, based 42 CFR Part 498
on the number of lives we expect would Administrative practice and 1. The authority citation for part 441
be saved by an increase in organ procedure, Health facilities, Health continues to read as follows:
donation and transplantation due to professions, Medicare, Reporting and Authority: Sec. 1102 of the Social Security
increased OPO performance. We have recordkeeping requirements. Act (42 U.S.C. 1302).
§ 441.13 [Amended] 486.322 Condition: Relationships with whose blood type does not match the
2. Section 441.13(c) is amended by hospitals, critical access hospitals, and blood type of the intended recipient.
tissue banks. Agreement cycle refers to the 4-year
removing the reference ‘‘part 485, 486.324 Condition: Administration and
subpart D’’ and adding ‘‘part 486 time period of the agreement between
governing body. CMS and an OPO. To provide sufficient
subpart G’’ in its place. 486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
time for CMS to analyze outcome
PART 486—CONDITIONS FOR 486.330 Condition: Information performance data and assign OPO
COVERAGE OF SPECIALIZED management. service areas, the OPO agreement cycle
SERVICES FURNISHED BY 486.342 Condition: Requesting consent. generally begins on August 1 of the year
SUPPLIERS 486.344 Condition: Donor evaluation and following the end of the re-certification
management, and organ placement and cycle and lasts for 4 years.
1. The authority citation for part 486 recovery. Certification means a determination
is revised to read as follows: 486.346 Condition: Organ preparation and by the Secretary that an OPO meets the
transport. requirements at § 486.303 and is eligible
Authority: Secs. 1102, 1138, and 1871 of
486.348 Condition: Quality assessment and for designation if it meets the additional
the Social Security Act (42 U.S.C. 1302,
performance improvement (QAPI).
1320b–g, and 1395hh) and section 371 of the requirements for designation.
Public Health Service Act (42 U.S.C 273).
Subpart G—Requirements for Death record review is an assessment
Certification and Designation and of the medical chart of a deceased
2. Section 486.1 is amended by
Conditions for Coverage: Organ patient to evaluate potential for organ
revising paragraph (a) to read as follows:
Procurement Organizations donation.
§ 486.1 Basis and scope. De-certification means a CMS
§ 486.301 Basis and scope. determination that an OPO no longer
(a) Statutory basis. This part is based
(a) Statutory basis. (1) Section 1138(b) meets one or more conditions for
on the following sections of the Act:
of the Act sets forth the requirements coverage, including the outcome
1102 and 1138(b)—for coverage of measures, the process performance
organ procurement services. that an organ procurement organization
(OPO) must meet to have its organ measures and other requirements, or no
1861(p)—for coverage of outpatient longer meets the requirements for
physical therapy services furnished by procurement services to hospitals
covered under Medicare and Medicaid. certification or designation. In addition,
physical therapists in independent if an OPO’s agreement with CMS is
practice. These include certification as a
‘‘qualified’’ OPO and designation as the terminated or is not renewed, the OPO
1861(s) (3), (15), and (17)—for is de-certified.
OPO for a particular service area.
coverage of portable X-ray services. Designated requestor is an individual
(2) Section 371(b) of the Public Health
* * * * * Service Act sets forth the requirements (generally employed by a hospital), who
3. Part 486 is further amended by for certification and the functions that a is trained to handle or participate in the
revising subpart G to read as follows: qualified OPO is expected to perform. donation consent process. The
(3) Section 1102 of the Act authorizes designated requestor may request
Subpart G—Requirements for the Secretary of Health and Human consent for donation from the family of
Certification and Designation and Services to make and publish rules and a potential donor or from the
Conditions for Coverage: Organ regulations necessary to the efficient individual(s) responsible for making the
Procurement Organizations administration of the functions that are donation decision in circumstances
assigned to the Secretary under the Act. permitted under State law, provide
Sec.
486.301 Basis and scope. (b) Scope. This subpart sets forth— information about donation to the
486.302 Definitions. (1) The conditions and requirements family or decision-maker(s), or provide
that an OPO must meet; support to or collaborate with the OPO
Requirements for Certification and (2) The procedures for certification in the donation consent process.
Designation and designation of OPOs; and Designation means CMS assignment
486.303 Requirements for certification. (3) The terms of the agreement with of a geographic service area to an OPO.
486.304 Requirements for designation. CMS and the basis for and the effect of Once an OPO is certified and assigned
486.306 OPO service area size designation termination or non-renewal of the a geographic service area, organ
and documentation requirements. agreement. procurement costs of the OPO are
486.308 Designation of one OPO for each (4) The requirements for an OPO to be eligible for Medicare and Medicaid
service area. re-certified for the performance data payment under section 1138(b)(1)(F) of
486.310 Changes in ownership or service the Act.
cycle from January 1, 2002 through
area. Donor means a deceased individual
December 31, 2005.
Re-Certification and De-Certification from whom at least one vascularized
§ 486.302 Definitions. organ (heart, liver, lung, kidney,
486.312 De-certification. As used in this subpart, the following
486.314 Appeals.
pancreas, or intestine) is recovered for
definitions apply: the purpose of transplantation.
486.316 Re-certification and competition
processes. Adverse event means an untoward, Donor document means any
undesirable, and usually unanticipated documented indication of an
Organ Procurement Organization event that causes death or serious injury individual’s choice in regard to
Outcome Requirements or the risk thereof. As applied to OPOs, donation that meets the requirements of
486.318 Condition: Outcome measures. adverse events include but are not the governing state law.
limited to transmission of disease from Entire metropolitan statistical area
Organ Procurement Organization a donor to a recipient, avoidable loss of means a metropolitan statistical area
Process Performance Measures a medically suitable potential donor for (MSA), a consolidated metropolitan
486.320 Condition: Participation in Organ whom consent for donation has been statistical area (CMSA), or a primary
Procurement and Transplantation obtained, or delivery to a transplant metropolitan statistical area (PMSA)
Network. center of the wrong organ or an organ listed in the State and Metropolitan
Area Data Book published by the U.S. Transplant hospital means a hospital enter into an agreement with CMS. The
Bureau of the Census. CMS does not that provides organ transplants and agreement is effective upon submission
recognize a CMSA as a metropolitan other medical and surgical specialty by the OPO and acceptance by CMS but
area for the purposes of establishing a services required for the care of may be canceled by either party. If an
geographical area for an OPO. transplant patients. There may be one or OPO is de-certified under § 486.312,
Open area means an OPO service area more types of organ transplant centers payment for organ procurement services
for which CMS has notified the public operating within the same transplant attributable to that OPO will not be
that it is accepting applications for hospital. made for services furnished on or after
designation. the effective date of the de-certification.
Organ means a human kidney, liver, Requirements for Certification and
In the agreement, the OPO must agree to
heart, lung, pancreas, or intestine (or Designation
do the following:
multivisceral organs when transplanted § 486.303 Requirements for certification. (1) Maintain compliance with the
at the same time as an intestine). In order to be certified, an organ requirements of titles XVIII and XIX of
Organ donor potential means the procurement organization must: the Act, section 1138 of the Act, section
number of patients whose age is 70 or (a) Have received a grant under 42 371(b) of the Public Health Service Act,
less meeting death by neurological U.S.C. 273(a). and applicable regulations, including
criteria, based on generally accepted (b) Be a non-profit entity that is the conditions set forth in this subpart
practice parameters for determining exempt from Federal income taxation and the rules and requirements of the
brain death, who do not have any of the under § 501 of the Internal Revenue OPTN, as defined by § 486.320, and to
following clinical indications: Code of 1986. report promptly to the Secretary any
(1) Tuberculosis. (c) Have accounting and other fiscal failure to do so.
(2) Creutzfeldt-Jacob Disease or any procedures necessary to assure the fiscal (2) Become a member of the OPTN.
other prion-induced disease. stability of the organization, including (3) File a cost report in accordance
(3) Viral septicemia. procedures to obtain payment for with § 413.24(f) of this chapter within 5
(4) Rabies. kidneys and non-renal organs provided months after the end of each fiscal year.
(5) Reactive hepatitis B surface to transplant hospitals. (4) Permit CMS to designate an
antigen. (d) Have an agreement with the intermediary to determine the interim
(6) Any retro virus infection. Secretary to be reimbursed under title payment rate payable to transplant
(7) Active malignant neoplasms, XVIII for the procurement of kidneys. hospitals for services provided by the
except primary central nervous system (e) Have been re-certified as an OPO OPO and to make a determination of
tumors and basal and squamous cell under the Medicare program from reasonable cost based on the cost report
carcinomas. January 1, 2002 through December 31, in the OPO files.
(8) Aplastic anemia. 2005. (5) Provide budget or cost projection
(9) Agranulocytosis. (f) Have procedures to obtain payment information as may be required to
(10) Active viral and systemic fungal for non-renal organs provided to establish an initial interim payment
infections. transplant centers. rate.
(11) Gangrene of bowel. (g) Agree to enter into an agreement (6) Pay to CMS amounts that have
(12) Extreme prematurity. with any hospital or critical access been paid by CMS to transplant
(13) Positive serological or viral hospitals as Medicare payment for organ
hospital in the OPO’s service area,
culture findings for HIV. recovery fees that are determined to be
including a transplant hospital, that
(14) Chagas disease. in excess of the reasonable cost of the
requests an agreement.
Organ procurement organization services provided by the OPO.
(h) Meet or have met the conditions
(OPO) means an organization that (7) Not charge an individual for items
for coverage, including the outcome
performs or coordinates the or services for which that individual is
measures and the process performance
procurement, preservation, and entitled to have payment made under
measures and other requirements.
transport of organs and maintains a the Medicare program.
system for locating prospective § 486.304 Requirements for designation. (d) Application for designation. An
recipients for available organs. (a) Designation is a condition for OPO that has met 4 out of 5 outcome
Potential donor denominator is the payment. Payment may be made under performance measures at or above the
basis for the OPO outcome measures. the Medicare and Medicaid programs mean for the previous re-certification
The potential donor denominator for organ procurement costs attributable cycle may apply for designation for the
indicates the number of individuals in to payments made to an OPO by a service area of an OPO that did not meet
an OPO’s service area who meet the hospital only if the OPO has been the conditions for coverage for the
criteria for organ donor potential. designated by the Secretary as an OPO. previous re-certification cycle. An OPO
Re-certification cycle means the 4- (b) Requirements for designation. An that has met 4 out of 5 outcome
calendar-year cycle of outcome measure OPO must do the following: performance measures at 100 percent of
data on which an OPO’s re-certification (1) Be certified as a qualified OPO by the mean may apply for designation
is based. The re-certification cycle the Secretary under 42 U.S.C. 273(b) whenever a service area becomes an
begins on January 1 and ends (4 years and § 486.303. open area if the OPO’s conversion rate
later) on December 31. (2) Enter into an agreement with CMS of potential donors to actual donors is
Service area means a geographical that meets the requirements set forth in at least 15 percentage points greater
area of sufficient size to ensure paragraph (c) of this section. than the conversion rate of the OPO
maximum effectiveness in the (3) Document that it has a defined currently designated for the service area.
procurement and equitable distribution service area that meets the requirements (e) Designation periods—
of organs and that either includes an of § 486.306. (1) General. An OPO is normally
entire metropolitan statistical area or (c) Agreement with CMS. In order for designated for 4 years. A designation
does not include any part of such an the organ procurement costs attributable period may be shorter, for example, an
area and that meets the standards of this to the OPO to be reimbursed under interim designation for the service area
subpart. Medicare and Medicaid, an OPO must of an OPO that has terminated its
agreement with CMS. A designation accordance with paragraph (d) of this an extent that it no longer satisfies the
period may be longer, for example, a section within 30 days of notice of the requirements for OPO designation, CMS
designation may be extended if change in designation. may de-certify the OPO and declare the
additional time is needed to select a (d) A hospital may request and CMS OPO’s service area to be an open area.
successor OPO to an OPO that has been may grant a waiver permitting the An OPO may appeal such a de-
de-certified. hospital to have an agreement with a certification as set forth in § 486.314.
(2) Re-designation. Re-certification designated OPO other than the OPO The OPO’s service area is not opened for
and re-designation must occur not more designated for the service area in which competition until the conclusion of the
frequently than every 4 years. the hospital is located. To qualify for a appeals process.
waiver, the hospital must submit data to (2) If CMS finds that the changed OPO
§ 486.306 OPO service area size CMS establishing that— continues to satisfy the requirements for
designation and documentation (1) The waiver is expected to increase
requirements.
OPO designation, the period of
organ donations; and designation of the changed OPO is the
(a) General documentation (2) The waiver will ensure equitable remaining portion of the 4 year term of
requirement. An OPO must make treatment of patients listed for the OPO that was reorganized. If more
available to CMS documentation transplants within the service area than one designated OPO is involved in
verifying that the OPO meets the served by the hospital’s designated OPO the reorganization, the remaining
requirements of paragraphs (b) through and within the service area served by designation term is the longest of the
(d) of this section at the time of the OPO with which the hospital seeks remaining periods unless CMS
application and throughout the period to enter into an agreement. determines that a shorter period is in
of its designation. (e) In making a determination on the best interest of the Medicare and
(b) Service area designation. The waiver requests, CMS considers— Medicaid programs. The changed OPO
defined service area either includes an (1) Cost effectiveness;
(2) Improvements in quality; must continue to meet the process
entire metropolitan statistical area or a performance measures and other
New England county metropolitan (3) Changes in a hospital’s designated
OPO due to changes in the definitions requirements at § 486.20 through
statistical area as specified by the § 486.48 throughout the remaining
Director of the Office of Management of metropolitan statistical areas, if
applicable; and period and must meet the outcome
and Budget or does not include any part measures at § 486.318 at the end of this
of such an area. (4) The length and continuity of a
hospital’s relationship with an OPO remaining period.
(c) Service area location and
characteristics. An OPO must define other than the hospital’s designated Re-Certification and De-Certification
and document a proposed service area’s OPO.
(f) A hospital may continue to operate § 486.312 De-certification.
location through the following
under its existing agreement with an (a) De-certification due to voluntary
information:
out-of-area OPO while CMS is termination of agreement. If an OPO
(1) The names of counties (or parishes
processing the waiver request. If a wishes to terminate its agreement, it
in Louisiana) served or, if the service
waiver request is denied, a hospital must send written notice of its intention
area includes an entire State, the name must enter into an agreement with the
of the State. to terminate its agreement and the
designated OPO within 30 days of proposed effective date of the
(2) Geographic boundaries of the notification of the final determination.
service area. termination to CMS. CMS may approve
(3) The number of and the names of § 486.310 Changes in ownership or service the proposed date, set a different date
all hospitals and critical access area. no later than 6 months after the
hospitals in the service area that have (a) OPO requirements. (1) A proposed effective date, or set a date
both a ventilator and an operating room. designated OPO considering a change in less than 6 months after the proposed
(d) It must procure organs from an ownership or in its service area must effective date if it determines that a
average of at least 24 donors per notify CMS before putting it into effect. different date would not disrupt
calendar year in the 4 years before the This notification is required to ensure services to the service area or otherwise
year of re-designation. that the OPO, if changed, will continue interfere with the effective and efficient
to satisfy Medicare and Medicaid administration of the Medicare and
§ 486.308 Designation of one OPO for each requirements. The merger of one OPO Medicaid programs. If CMS determines
service area. that a designated OPO has ceased to
into another or the consolidation of one
(a) CMS designates only one OPO per OPO with another is considered a furnish organ procurement services to
service area. A service area is open for change in ownership. its service area, the cessation of services
competition once the existing (2) A designated OPO considering a is deemed to constitute a voluntary
designation period has expired or when change in its service area must obtain termination by the OPO, effective on a
the existing designated status of the prior CMS approval. In the case of a date determined by CMS. CMS will de-
OPO for the service area has been service area change that results from a certify the OPO as of the effective date
terminated. change of ownership due to merger or of the voluntary termination.
(b) Unless CMS has granted a hospital consolidation, the OPOs must resubmit (b) De-certification due to involuntary
a waiver under paragraphs (d) through the information required in an termination of agreement. CMS may
(f) of this section, the hospital must application for designation. The OPO terminate an agreement with an OPO if
enter into an agreement only with the must provide information specific to the CMS finds that the OPO no longer meets
OPO designated to serve the area in board structure of the new organization, the requirements for designation or
which the hospital is located. as well as operating budgets, financial certification or the conditions for
(c) If CMS changes the OPO information, and other written coverage in this subpart or is not in
designated for an area, hospitals located documentation CMS determines to be substantial compliance with any other
in that area must enter into agreements necessary for designation. applicable Federal regulations or
with the newly designated OPO or (b) CMS requirements. (1) If CMS provisions of titles XI, XVIII, or XIX of
submit a request for a waiver in finds that the OPO has changed to such the Act. CMS may also terminate an
agreement immediately in cases of (c) De-certification is upheld. If the degree of success in meeting the process
urgent need, such as the discovery of de-certification determination is upheld performance measures during the
unsound medical practices. CMS will by the hearing officer, Medicare and preceding re-certification cycle and the
de-certify the OPO as of the effective Medicaid payment may not be made for submission of an acceptable plan to
date of the involuntary termination. organ procurement services the OPO increase organ donation in the open
(c) De-certification due to non- furnishes on or after the effective date service area. An acceptable plan to
renewal of agreement. CMS will not of de-certification. There are no further increase organ donation, at a
voluntarily renew its agreement with an administrative appeal rights. minimum—
OPO if the OPO fails to meet the (d) Effects of de-certification. When (1) Is based on the competing OPO’s
condition for coverage at § 486.318 an OPO agreement is terminated or is experience and success in its own
based on data from the most recent re- not renewed, CMS will accept service area;
certification cycle or if the OPO’s applications from other OPOs to be (2) Includes an analysis of existing
designation has been terminated. CMS designated for the open area as set forth barriers, both internal and external, to
will de-certify the OPO as of the ending in § 486.316(b). An OPO that is de- increasing organ donation in the open
date of the agreement. certified may not apply or be designated area; and
(d) Notice to OPO. Except in cases of for an open area. (3) Provides a detailed description of
urgent need, CMS gives written notice (e) Extension of agreement. If there is specific activities and interventions for
of de-certification to an OPO at least 90 insufficient time prior to expiration of increasing organ donation in the open
days before the effective date of the de- an agreement with CMS to allow for service area.
certification. In cases of urgent need, competition of the service area and, if (d) No OPO applies. If no OPO applies
CMS gives written notice of de- necessary, transition of the service area to compete for the open area, CMS may
certification at least three calendar days to a successor OPO, CMS may choose to select a single OPO to take over the
prior to the effective date of the de- extend the OPO’s agreement with CMS entire open area or may adjust the
certification. The notice of de- for a period not to exceed an additional service area boundaries of two or more
certification states the reason for de- 60 days. contiguous OPOs to incorporate the
certification and the effective date. open area. CMS will make its decision
(e) Public notice. Once CMS approves § 486.316 Re-certification and competition
processes. based on the OPOs’ success in meeting
the date for a voluntary termination, the the process performance measures
OPO must provide prompt public notice CMS opens all OPO service areas for
during the preceding re-certification
of the date of de-certification and such competition at the end of every re-
cycle.
other information as CMS may require certification cycle.
through publication in local newspapers (a) OPO meets conditions for Organ Procurement Organization
in the service area. In the case of coverage. When an OPO meets the Outcome Requirements
involuntary termination or non-renewal outcome measures in § 486.318 and has
been found to be in compliance with the § 486.318 Condition: Outcome measures.
of an agreement, CMS provides public
notice of the date of de-certification process performance measures and (a) With the exception of OPOs
through publication in local newspapers other requirements in §§ 486.320 operating exclusively in non-contiguous
in the service area. No payment under through 486.348, CMS will open the U.S. States, U.S. territories, U.S.
title XVIII or title XIX of the Act will be OPO’s service area for competition. An possessions, or U.S. commonwealths, an
made with respect to organ procurement OPO may compete for the open area OPO must achieve at least 75 percent of
costs attributable to the OPO on or after only if it met 4 out of 5 outcome the national mean in 4 of the 5
the date the de-certification is effective. measures at or above 100 percent of the following performance categories,
mean for the preceding re-certification averaged over the 4 calendar years
§ 486.314 Appeals. cycle and its conversion rate of potential before the year of re-certification:
If an OPO’s de-certification is due to donors to actual donors is at least 15 (1) Donors, as a percentage of the
involuntary termination or non-renewal percentage points higher than the potential donor denominator.
of its agreement with CMS, the OPO conversion rate of the OPO currently (2) Number of kidneys procured, as a
may appeal the de-certification on designated for the service area. The OPO percentage of the potential donor
substantive or procedural grounds. must compete for the entire service area. denominator.
(a) Appeal process. The OPO must file The incumbent OPO may compete for (3) Number of kidneys transplanted,
its appeal within 30 calendar days of the its own service area. as a percentage of the potential donor
date of the notice of de-certification. In (b) OPO does not meet conditions for denominator.
its appeal, the OPO may submit coverage. If CMS notifies an OPO that it (4) Number of extra-renal organs
evidence to demonstrate why it should will be de-certified because its procured, as a percentage of the
not be de-certified. Within 2 weeks of agreement will not be renewed or will potential donor denominator.
receipt of the OPO’s appeal, a CMS be terminated by CMS, and the OPO (5) Number of extra-renal organs
hearing officer will schedule a hearing. does not appeal within the time frame transplanted, as a percentage of the
The hearing officer will issue notice of specified in § 486.314(a) or the OPO’s potential donor denominator.
his or her decision to the OPO by de-certification is upheld on appeal, (b) An OPO operating exclusively in
certified mail within 2 weeks of the CMS will open the OPO’s service area non-contiguous U.S. States, U.S.
hearing. for competition from other OPOs. An territories, U.S. possessions, or U.S.
(b) Reversal of de-certification. If the OPO may compete for the open service commonwealths must meet the
hearing officer reverses CMS’ area only if it met 4 out of 5 outcome following outcome measures at 50
determination to de-certify an OPO in a measures at or above the mean for the percent or more of the national mean,
case involving the involuntary preceding re-certification cycle. The averaged over the 4 calendar years
termination of the OPO’s agreement, OPO must compete for the entire area. before the year of re-certification:
CMS will not terminate the OPO’s (c) Criteria for selection. CMS will (1) Number of kidneys procured, as a
agreement and will not de-certify the designate an OPO for an open service percentage of the potential donor
OPO at that time. area based on the competing OPOs’ denominator.
(2) Number of kidneys transplanted, (2) An OPO is not required to have an with the etiologic agent for acquired
as a percentage of the potential donor arrangement with a tissue bank that is immune deficiency syndrome.
denominator. unwilling to have an arrangement with (5) Appropriate tissue typing of
the OPO. organs.
Organ Procurement Organization (6) A system for allocation of organs
Process Performance Measures § 486.324 Condition: Administration and among transplant patients that is
governing body. consistent with the rules and
§ 486.320 Condition: Participation in
Organ Procurement and Transplantation (a) While an OPO may have more than requirements of the OPTN, as defined in
Network. one board, the OPO must have an § 486.320 of this part.
advisory board that has both the (7) Transportation of organs to
After being designated, an OPO must
authority described in paragraph (b) of transplant hospitals.
become a member of and abide by the
this section and the following (8) Coordination of activities with
rules and requirements of the OPTN
membership: transplant hospitals in the OPO’s
established and operated in accordance (1) Members who represent hospital
with section 372 of the Public Health service area.
administrators, voluntary health (9) Participation in the OPTN.
Service Act (42 U.S.C. 274). The term associations in the OPO’s service area, (10) Arrangements to cooperate with
‘‘rules and requirements of the OPTN’’ and either intensive care or emergency tissue banks for the retrieval,
means those rules and requirements room personnel. processing, preservation, storage, and
approved by the Secretary. No OPO is (2) An individual from a tissue bank distribution of tissues as may be
considered out of compliance with who represents all tissue banks that appropriate to assure that all useable
section 1138(b)(1)(D) of the Act or this have agreements with hospitals with tissues are obtained from potential
section until the Secretary approves the which the OPO has agreements (if such donors.
determination that the OPO failed to an individual is available to serve on the (11) Annual evaluation of the
comply with the rules and requirements board). The individual must be from a effectiveness of the OPO in acquiring
of the OPTN. The Secretary may impose tissue bank not affiliated with the OPO, organs.
sanctions under section 1138 only after unless the only tissue bank in the (12) Assistance to hospitals in
such non-compliance has been service area is affiliated with the OPO. establishing and implementing
determined in this manner. (3) Individuals who represent the protocols for making routine inquiries
§ 486.322 Condition: Relationships with public residing in the OPO’s service about organ donations by potential
hospitals, critical access hospitals, and area. donors.
tissue banks. (4) A physician with knowledge, (c) The advisory board described in
(a) Standard: Hospital agreements. An experience, or skill in the field of paragraph (a) of this section has no
OPO must have a written agreement human histocompatibility or an authority over any other activity of the
with 95 percent of the hospitals and individual with a doctorate degree in a OPO and may not serve as the OPO’s
critical access hospitals in its service biological science and with knowledge, governing body or board of directors.
area that have both a ventilator and an experience, or skills in the field of Members of the advisory board
operating room and have not been human histocompatibility. described in paragraph (a) of this
granted a waiver by CMS to work with (5) A neurosurgeon or other physician section are prohibited from serving on
another OPO. The agreement must with knowledge or skills in any other OPO board.
describe the responsibilities of both the neurosciences. (d) The OPO must have bylaws for
(6) A transplant surgeon representing each of its board(s) that address
OPO and hospital or critical access
each transplant hospital in the service potential conflicts of interest, length of
hospital in regard to the requirements
area with which the OPO has terms, and criteria for selecting and
for hospitals at § 482.45 or § 485.643
arrangements to coordinate its activities. removing members.
and specify the meaning of the terms
The transplant surgeon must have (e) A governing body must have full
‘‘timely referral’’ and ‘‘imminent death.’’
practicing privileges and perform legal authority and responsibility for the
(b) Standard: Designated requestor
transplants in the transplant hospital management and provision of all OPO
training for hospital staff. The OPO
represented. services and must develop and oversee
must offer designated requestor training (b) The advisory board described in
on at least an annual basis for hospital implementation of policies and
paragraph (a) of this section has the procedures considered necessary for the
and critical access hospital staff. authority to recommend policies for the effective administration of the OPO,
(c) Standard: Cooperation with tissue following: including fiscal operations, the OPO’s
banks. (1) The OPO must have (1) Procurement of organs. quality assessment and performance
arrangements to cooperate with tissue (2) Effective agreements to identify improvement (QAPI) program, and
banks that have agreements with potential organ donors with a services furnished under contract or
hospitals and critical access hospitals substantial majority of hospitals in its arrangement, including agreements for
with which the OPO has agreements. service area that have facilities for organ these services. The governing body must
The OPO must cooperate in the donation. appoint an individual to be responsible
following activities, as may be (3) Systematic efforts, including for the day-to-day operation of the OPO.
appropriate, to ensure that all usable professional education, to acquire all (f) The OPO must have a procedure to
tissues are obtained from potential useable organs from potential donors. address potential conflicts of interest for
donors: (4) Arrangements for the acquisition the governing body described in
(i) Screening and referral of potential and preservation of donated organs and paragraph (e) of this section.
tissue donors. provision of quality standards for the
(ii) Obtaining informed consent from acquisition of organs that are consistent § 486.326 Condition: Human resources.
families of potential tissue donors. with the standards adopted by the All OPOs must have a sufficient
(iii) Retrieval, processing, OPTN, including arranging for testing number of qualified staff, including a
preservation, storage, and distribution of with respect to preventing the director, a medical director, organ
tissues. acquisition of organs that are infected procurement coordinators, and hospital
development staff to obtain all usable (d) Standard: Medical director. The (2) Kidneys transplanted. Each kidney
organs from potential donors, and to OPO’s medical director is responsible transplanted will be counted
ensure that required services are for implementation of the OPO’s individually. En bloc kidney transplants
provided to families of potential donors, protocols for donor evaluation and will be counted as two kidneys
hospitals, tissue banks, and individuals management and organ recovery and transplanted.
and facilities that use organs for placement. The medical director is (3) Extra-renal organs procured. Each
research. responsible for oversight of the clinical organ recovered is counted individually.
(a) Standard: Qualifications. (1) The management of potential donors, (4) Extra-renal organs transplanted.
OPO must ensure that all individuals including providing assistance in Each organ or part thereof transplanted
who provide services and/or supervise managing a donor case when the will be counted individually. For
services, including services furnished surgeon on call is unavailable. example, a single liver is counted as one
under contract or arrangement, are organ procured and each portion that is
§ 486.328 Condition: Reporting of data. transplanted will count as a transplant.
qualified to provide or supervise the
services. (a) The OPO must provide Further, a heart and double lung
(2) The OPO must develop and individually-identifiable, hospital- transplant will be counted as three
implement a written policy that specific organ donation and organs transplanted. A kidney/pancreas
addresses potential conflicts of interest transplantation data to the OPTN and transplant will count as one kidney
for the OPO’s director, medical director, the Scientific Registry of Transplant transplanted and one extra-renal organ
and senior management, and Recipients (SRTR), as directed by the transplanted.
procurement coordinators. Secretary. The OPO must provide (d) The OPO must report hospital-
(3) The OPO must have credentialing hospital-specific organ donation data to specific organ donation data, including
records for physicians and other transplant hospitals, annually. The OPO organ donor potential and the number of
practitioners who routinely recover must report individually-identifiable, donors, to the public at least annually.
organs in hospitals under contract or hospital-specific organ donation and
transplantation data and other § 486.330 Condition: Information
arrangement with the OPO and ensure management.
that all physicians and other information to the Department, as
requested by the Secretary. The data An OPO must establish and use an
practitioners who recover organs in information management system to
hospitals with which the OPO has may include, but are not limited to—
(1) Number of hospital deaths; maintain the required medical, social
agreements are qualified and trained. and identifying information for every
(2) Results of death record reviews;
(b) Standard: Staffing. (1) The OPO donor and transplant recipient and
(3) Number and timeliness of referral
must provide sufficient coverage, either develop and follow procedures to
calls from hospitals;
by its own staff or under contract or (4) Potential donor denominator (as ensure the confidentiality and security
arrangement, to assure both that defined in § 486.302); of the information.
hospital referral calls are screened for (5) Data related to non-recovery of (a) Donor information. The OPO must
donor potential and that potential organs; maintain a record for every donor. The
donors are evaluated for medical (6) Data about consents for donation; record must include, at a minimum,
suitability in a timely manner. (7) Number of donors; information identifying the donor (for
(2) The OPO must have a sufficient (8) Number of organs recovered (by example, name, address, date of birth,
number of qualified staff to provide type of organ); and social security number or other unique
information and support to potential (9) Number of organs transplanted (by identifier, such as Medicare health
organ donor families; request consent type of organ). insurance claim number), organs and
for donation; ensure optimal (b) The potential donor denominator (when applicable) tissues recovered,
maintenance of the donor, efficient data reported to the OPTN to be used for date of the organ recovery, donor
placement of organs, and adequate OPO re-certification must include data management data, all test results,
oversight of organ recovery; and for all deaths that occurred in hospitals current hospital history, past medical
conduct QAPI activities, such as death and critical access hospitals in the and social history, the pronouncement
record reviews and hospital OPO’s service area, unless a hospital or of death, and consent and next-of-kin
development. critical access hospital has been granted information.
(3) The OPO must provide a sufficient a waiver under 486.308(d) to work with (b) Disposition of organs. The OPO
number of recovery personnel, either a different OPO. Data reported by the must maintain records showing the
from its own staff or under contract or OPO to the OPTN must be reported disposition of each organ recovered for
arrangement, to ensure that all usable within 30 days after the end of the the purpose of transplantation,
organs are recovered in a manner that, month in which a death occurred. If an including information identifying
to the extent possible, preserves them OPO determines through death record transplant recipients.
for transplantation. review or other means that the potential (c) Data retention. Donor and
(c) Standard: Education, training, and donor denominator data it reported to transplant recipient records must be
performance evaluation. The OPO must the OPTN was incorrect, it must report maintained in a human readable and
provide its staff with the education, the corrected data to the OPTN within reproducible paper or electronic format
training, and supervision necessary to 30 days of the end of the month in for 7 years.
furnish required services. Training must which the mistake is identified. (d) Format of records. The OPO must
include but is not limited to (c) For the purpose of determining the maintain data in a format that can
performance expectations for staff, information to be collected under readily be transferred to a successor
applicable organizational policies and paragraph (a) of this section, the OPO and in the event of a transfer must
procedures, and QAPI activities. OPOs following definitions apply: provide to CMS copies of all records,
must evaluate the performance of their (1) Kidneys procured. Each kidney data, and software necessary to ensure
staffs and provide training, as needed, to recovered will be counted individually. uninterrupted service by a successor
improve individual and overall staff En bloc kidneys recovered will count as OPO. Records and data subject to this
performance and effectiveness. two kidneys procured. requirement include donor and
transplant recipient records and ensuring that donor evaluation and practices in the field and maximize
procedural manuals and other materials management protocols are implemented organ donation.
used in conducting OPO operations. correctly and appropriately to ensure (e) Documentation of recipient
that every potential donor is thoroughly information. Prior to recovery of an
§ 486.342 Condition: Requesting consent. assessed for medical suitability for organ for transplantation, the OPO must
An OPO must encourage discretion organ donation and clinically managed have written documentation from the
and sensitivity with respect to the to optimize organ viability and function. OPTN showing, at a minimum, the
circumstances, views, and beliefs of (2) The OPO must implement a intended recipient’s position on the
potential donor families. system that ensures the medical director waiting list in relation to other suitable
(a) An OPO must have a written or other qualified physician is available candidates and the recipient’s OPTN
protocol to ensure that, in the absence to assist in the medical management of identification number and blood type.
of a donor document, the individual(s) a donor when the surgeon on call is (f) Organ allocation. The OPO must
responsible for making the donation unavailable. have a system to allocate donated organs
decision are informed of their options to (b) Evaluation. The OPO must do the among transplant patients that is
donate organs or tissues (when the OPO following: consistent with the rules and
is making a request for tissues) or to (1) Verify that death has been requirements of the OPTN, as defined in
decline to donate. The OPO must pronounced according to applicable § 486.320 of this part.
provide to the individual(s) responsible local, state, and federal laws pertaining (g) Organ placement. The OPO must
for making the donation decision, at a to organ donation. develop and implement a protocol to
minimum, the following: (2) Determine whether there are maximize placement of organs for
(1) A list of the organs or tissues that conditions that may contraindicate transplantation.
may be recovered. donation.
(2) All possible uses for the donated (3) If possible, obtain the potential § 486.346 Condition: Organ preparation
organs or tissues. donor’s medical and social history. and transport.
(3) The information that the (4) Review the potential donor’s (a) The OPO must arrange for testing
individual(s) have the right to limit or medical chart and perform a physical of organs for infectious disease and
restrict use of the organs or tissues. examination of the donor. tissue typing of organs according to
(4) A description of the screening and (5) Obtain the donor’s vital signs and current standards of practice. The OPO
recovery processes. perform all pertinent tests. must ensure that testing and tissue
(5) Information (such as for-profit or (c) Testing. The OPO must do the typing of organs are conducted by a
non-profit status) about organizations following: laboratory that is certified in the
that will recover, process, and distribute (1) Arrange for screening and testing appropriate specialty or subspecialty of
the tissue. of the donor for infectious disease service in accordance with part 493 of
(6) Information regarding access to according to current standards of this chapter.
and release of the donor’s medical practice, including testing for the (b) The OPO must send complete
records. human immunodeficiency virus. documentation of donor information to
(7) An explanation of the impact the (2) Ensure that screening and testing the transplant center with the organ,
donation process will have on burial of the donor (including point-of-care including donor evaluation, the
arrangements and the appearance of the testing and blood typing) are conducted complete record of the donor’s
donor’s body. by a laboratory that is certified in the
(8) Information about the procedure management, documentation of consent,
appropriate specialty or subspecialty of documentation of the pronouncement of
for filing a complaint. service in accordance with part 493 of
(9) Contact information in case the death, and documentation for
this chapter. determining organ quality. Two OPO
individual(s) making the donation (3) Ensure that the donor’s blood is
decision have questions. staff members must verify that the
typed using two separate blood samples. documentation that accompanies an
(10) A copy of the signed consent
(4) Document the donor’s record with organ to a transplant center is correct.
form if a donation is made.
all test results, including blood type, (c) The OPO must develop and follow
(b) If an OPO does not request consent
before organ recovery. a written protocol for packaging,
to donation because a potential donor
(d) Standard: Collaboration with labeling, handling, and shipping organs
consented to donation before his or her
transplant programs. (1) The OPO must in a manner that ensures their arrival
death in a manner that satisfied
establish protocols in collaboration with without compromise to the quality of
applicable State law requirements in the
transplant programs that define the roles the organ or health of the recipient. The
potential donor’s State of residence, the
and responsibilities of the OPO and the protocol must include procedures to
OPO must provide information about
transplant program for all activities check the accuracy and integrity of
the donation to the family of the
associated with donor evaluation, donor labels, packaging, and contents prior to
potential donor, as requested.
management, organ recovery, and organ transport, including verification by two
§ 486.344 Condition: Donor evaluation and placement. The protocol for organ OPO staff members that information
management and organ placement and placement must include procedures to listed on the labels is correct.
recovery. ensure that the blood type of the donor (d) All packaging in which an organ
The OPO must have written protocols is compared with the blood type of the is transported must be marked with the
for donor evaluation and management intended recipient by two OPO staff identification number, specific contents,
and organ placement and recovery that members before organ recovery takes and donor’s blood type.
meet current standards of practice and place and that documentation of the
are designed to maximize organ quality donor’s blood type accompanies the § 486.348 Condition: Quality assessment
and optimize the number of donors and organ to the hospital where the and performance improvement (QAPI).
the number of organs recovered and transplant will take place. The OPO must develop, implement,
transplanted per donor. (2) The established protocols must be and maintain a comprehensive, data-
(a) Donor protocol management. (1) reviewed periodically with the driven QAPI program designed to
The medical director is responsible for transplant programs to incorporate best monitor and evaluate performance of all
donation services, including services address adverse events that occur Authority: Secs. 1102 and 1871 of the
provided under contract or arrangement. during any phase of an organ donation Social Security Act (42 U.S.C. 1302 and
(a) Standard: Components of a QAPI case. The policy must address, at a 1395hh).
program. The OPO’s QAPI program minimum, the process for identification,
must include objective measures to reporting, analysis, and prevention of Subpart A—General Provisions
evaluate and demonstrate improved adverse events. § 498.2 [Amended]
performance with regard to OPO (2) The OPO must conduct a thorough
activities, such as hospital development, analysis of any adverse event and must 2. In § 498.2, the definition of
designated requestor training, donor use the analysis to affect changes in the ‘‘Supplier’’ is amended by removing
management, timeliness of on-site OPO’s policies and practices to prevent ‘‘organ procurement organization
response to hospital referrals, consent repeat incidents. (OPO),’’.
practices, organ recovery and (3) The OPO must—
placement, and organ packaging and (Catalog of Federal Domestic Assistance
(i) Report an adverse event to CMS Program No. 93.778, Medical Assistance
transport. The OPO must take actions within 10 business days of becoming
that result in performance Program)
aware of the adverse event; and
improvements and track performance to (Catalog of Federal Domestic Assistance
(ii) Provide to CMS written
ensure that improvements are sustained. Program No. 93.773, Medicare—Hospital
documentation of the investigation and Insurance; and Program No. 93.774,
(b) Standard: Death record reviews. analysis of the adverse event within 15
As part of its ongoing QAPI efforts, an Medicare—Supplementary Medical
business days of becoming aware of the Insurance Program)
OPO must conduct death record reviews event.
in every Medicare and Medicaid Editorial Note: This document was
participating hospital in its service area PART 498—APPEALS PROCEDURES received in the Office of the Federal Register
that has a level I or level II trauma FOR DETERMINATIONS THAT AFFECT on January 26, 2005.
center or 150 or more beds (unless the PARTICIPATION IN THE MEDICARE
hospital has a waiver to work with Approved: July 29, 2004.
PROGRAM AND FOR
another OPO), with the exception of Tommy G. Thompson,
DETERMINATIONS THAT AFFECT THE
psychiatric and rehabilitation hospitals. PARTICIPATION OF ICFs/MR AND Secretary.
When missed opportunities for donation CERTAIN NFs IN THE MEDICAID [FR Doc. 05–1695 Filed 1–28–05; 8:45 am]
are identified, the OPO must implement PROGRAM BILLING CODE 4120–01–P
actions to improve performance.
(c) Standard: Adverse events. (1) An 1. The authority citation for part 498
OPO must establish a written policy to continues to read as follows:

Proposed Rule: Medicare: Organ Procurement Organizations New Standards For Coverage

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Proposed Rule: Medicare: Organ Procurement Organizations New Standards For Coverage

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Friday,

42 CFR Parts 413, 441, et al.

transplantation as a percentage of the 2. AOPO Recommendations be assessed using second-tier measures

ESTIMATED ONE-YEAR COSTS OF NON-RENAL TRANSPLANTS

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

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

As discussed elsewhere in this Health professionals, Medicare, Organ PART 441—SERVICES:

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