[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Rules and Regulations]
[Pages 30982-31054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4882]
[[Page 30981]]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 413, 441, et al.
Medicare and Medicaid Programs; Conditions for Coverage for Organ
Procurement Organizations (OPOs); Final Rule
Federal Register / Vol. 71, No. 104 / Wednesday, May 31, 2006 / Rules
and Regulations
[[Page 30982]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 413, 441, 486 and 498
[CMS-3064-F]
RIN: 0938-AK81
Medicare and Medicaid Programs; Conditions for Coverage for Organ
Procurement Organizations (OPOs)
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This rule finalizes the February 4, 2005 proposed rule
entitled ``Medicare and Medicaid Programs; Conditions for Coverage for
Organ Procurement Organizations (OPOs).'' It establishes new conditions
for coverage for organ procurement organizations (OPOs) that include
multiple new outcome and process performance measures based on organ
donor potential and other related factors in each service area of
qualified OPOs. Our goal is to improve OPO performance and increase
organ donation. In addition, this final rule re-certifies these 58 OPOs
from August 1, 2006 through July 31, 2010 and provides an opportunity
for them to sign agreements with the Secretary that will begin on
August 1, 2006 and end on January 31, 2011. New agreements are needed
so that the Medicare and Medicaid Programs can continue to pay them for
their organ procurement activities after July 31, 2006.
DATES: Effective Dates: These regulations are effective July 31, 2006.
FOR FURTHER INFORMATION CONTACT:
Marcia Newton, (410) 786-5265.
Diane Corning, (410) 786-8486.
Jeannie Miller, (410) 786-3164.
Rachael Weinstein, (410) 786-6775.
I. Background
A. Organ Procurement Organizations and Their Importance
OPOs play a crucial role in ensuring that an immensely valuable,
but scarce resource--transplantable human organs--becomes available to
seriously ill patients who are on a waiting list for an organ
transplant.
OPOs are responsible for identifying potential organ donors and for
obtaining as many organs as possible from those donors. They are also
responsible for ensuring that the organs they obtain are properly
preserved and quickly delivered to a suitable recipient awaiting
transplantation. Therefore, OPO performance is a critical element of
the organ transplantation system in the United States. An OPO that is
efficient in procuring organs and delivering them to recipients will
save more lives than an ineffective OPO.
The nation's 58 OPOs are responsible for all organ recovery from
deceased donors in the United States; without OPOs, organs from
deceased donors will not be recovered. Without recovery of organs from
deceased donors, only organs from living donors will be recovered and
transplanted, and many patients waiting for organs will die.
B. Key Statutory Provisions
The Organ Procurement Organization Certification Act of 2000
(section 701 of Pub. L. 106-505) and section 219 of the Conference
Report accompanying the Consolidated Appropriations Act, 2001 (Pub. L.
106-554) contain identical provisions that amended section 371(b)(1) of
the Public Health Service (PHS) Act (42 U.S.C. 273(b)(1)). The
legislation directs the Secretary to establish regulations that include
four major requirements. These are to:
1. Increase the re-certification cycle for OPOs from 2 to at least
4 years.
2. Establish outcome and process performance measures based on
empirical evidence, obtained through reasonable efforts, of organ donor
potential and other related factors in each service area of qualified
OPOs.
3. Establish multiple outcome measures.
4. Establish a process for OPOs to appeal a de-certification on
substantive and procedural grounds.
The re-certification cycle was increased from 2 years to 4 years
through an interim final rule with comment period, ``Emergency Re-
certification for Coverage for Organ Procurement Organizations
(OPOs),'' that re-certified all 59 (now 58) OPOs until December 31,
2005 and extended their agreements with us until July 31, 2006.
(December 28, 2001, 66 FR 67109)
Section 1138 of the Social Security Act (the Act) (42 U.S.C. 1320b-
8) provides the statutory qualifications and requirements that an OPO
must meet in order for organ procurement costs to be reimbursed under
the Medicare or Medicaid programs. Section 1138(b) of the Act also
specifies that an OPO must operate under a grant made under section
371(a) of the PHS Act or must be certified or re-certified by the
Secretary as meeting the standards to be a qualified OPO. Under these
authorities, we previously established conditions for coverage for OPOs
at 42 CFR 486.301, et seq. (May 2, 1996, 61 FR 19722).
Section 1102 of the Act gives the Secretary of Health and Human
Services the authority to make and publish such rules and regulations
as may be necessary to the efficient administration of the functions
with which he is charged under the Act. Moreover, section 1871 of the
Act gives the Secretary broad authority to establish regulations that
are necessary to carry out the administration of the Medicare program.
C. HHS Initiatives Related to OPOs' Services
As discussed in the preamble of the February 4, 2005 proposed rule
(70 FR 6086), in April 2003, the Secretary of the Department of Health
and Human Services (HHS) initiated the Organ Donation Breakthrough
Collaborative (the Collaborative). HHS's Health Resources and Services
Administration (HRSA) was charged with overseeing the Collaborative
because HRSA's Division of Transplantation administers the Federal
contracts for the Organ Procurement and Transplantation Network (OPTN)
and Scientific Registry of Transplant Recipients (SRTR) and has
considerable experience and expertise in organ donation and
transplantation. According to the Collaborative's Web site, ``The
purpose of the Collaborative is to generate significant, measurable
organ donation by helping the national community of organ procurement
organizations and hospitals to identify, learn, adapt, replicate, and
celebrate ``breakthrough'' practices associated with higher donation
rates. Furthermore, it is designed to enhance the understanding of
existing knowledge as well as contribute vital information about
increasing organ donation rates.'' (http://organdonation.iqsolutions.com/).
Although the Collaborative has not yet met all of its goals, organ
donation has increased significantly since the Collaborative began in
April 2003. After years of single-digit annual improvements, organ
donation increased by nearly 11 percent from 2003 to 2004.
All 58 OPOs are now participating in the Collaborative to varying
degrees. Based upon the percentage of potential donors that become
actual donors (that is, the donation rate), every OPO improved its
performance after joining the Collaborative.
We believe that OPOs will sustain the gains they have made to
improve their performance due to a variety of factors. We have four
Regional OPO Coordinators, who work directly with
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the OPOs to increase organ donation rates by assisting them in
developing and implementing quality improvement programs. In addition,
they also make periodic quality visits to identify areas in which an
OPO needs to improve. Our Regional OPO Coordinators collaborate with
HRSA, the OPOs, and the hospitals to ensure the continuous
implementation of best practices identified through the Collaborative.
However, it is important to note that the Collaborative is a voluntary
initiative and, as such, has no enforcement mechanism.
D. Requirements for OPOs
To be an OPO, an entity must meet the applicable requirements of
the Public Health Service Act (42 U.S.C. 273(b)(1)). Among other
requirements, the OPO must be certified or re-certified by the
Secretary. To receive payment from the Medicare and Medicaid programs
for organ procurement costs, the entity must have an agreement with the
Secretary. In addition, under section 1138 of the Social Security Act,
an OPO must meet performance standards prescribed and designated by the
Secretary. CMS is delegated the responsibility to designate each OPO
for a specific geographic service area.
We re-certified the 58 OPOs through December 31, 2005 and
designated each OPO for a specific geographic service area. Each OPO
has an agreement with the Secretary that is valid through July 31,
2006. New agreements must be executed to extend the government's
ability to make payment beyond July 31, 2006 and keep the nation's
organ donation system in operation. In this final rule, we re-certify
all 58 OPOs from August 1, 2006 through July 31, 2010 and re-designate
them for the same geographic service areas. We will seek to enter into
a new agreement with each OPO by July 31, 2006. These agreements will
expire on January 31, 2011. Should an OPO not agree to sign the
agreement, we would open the OPO's service area for competition from
other OPOs using the procedures established in Sec. 486.316 of this
final rule.
II. Summary of the Proposed Provisions and Response to Comments on the
February 4, 2005 Proposed Rule
In this final rule, we re-certify the 58 currently certified OPOs
from August 1, 2006 through July 31, 2010. Each OPO will retain its
currently designated service area. Since the OPOs' current agreements
with the Secretary expire July 31, 2006, prior to that date, we will
request each OPO to sign a new agreement with an ending date of January
31, 2011.
The February 4, 2005 proposed rule set forth new conditions for
coverage for OPOs, including multiple new outcome and process
performance measures based on organ donor potential and other related
factors in each service area of qualified OPOs. We proposed new
standards with the goal of improving OPO performance and increasing
organ donation. We published the proposed rule with a 60-day public
comment period ending on April 5, 2005. However, because individuals
and organizations requested additional time for analysis of our
proposals, we extended the comment period for an additional 60 days to
June 6, 2005. We received 129 timely comments on the proposed rule.
Interested parties that commented included: National organizations that
represent OPOs, transplant surgeons and physicians, and organ
procurement and transplant coordinators; state hospital associations
and health departments; OPOs; tissue banks; medical examiners and
coroners; large donor and transplant hospitals; Federally contracted
organizations that oversee the nation's organ donation and
transplantation systems; researchers; members of the public; and
others. Below we provide a brief summary of each proposed provision, a
summary of the public comments we received, and our responses to the
comments.
Donation After Cardiac Death
We did not include any requirements for donation after cardiac
death in our proposed rule. However, commenters expressed concern that
the proposed rule did not address donation after cardiac death,
pointing out that recovering organs from DCDs has increased in recent
years and that recovering organs from DCDs will help address the
shortage of organs for transplantation.
We agree that we should not ignore a practice that is becoming
increasingly common across the United States and that has the potential
to increase the supply of transplantable organs significantly. While
commenters did not recommend specific requirements that we should
consider including in the final rule, we believe donation after cardiac
death is best addressed in three separate sections: Sec. 486.322,
Relationships with hospitals, critical access hospitals, and tissue
banks; Sec. 486.328, Administration and governing body; and Sec.
486.344, Evaluation and management of potential donors and organ
replacement and recovery. First, at Sec. 486.322, we require that an
OPO's agreement with its hospital must describe the responsibilities of
both the OPO and the hospital or critical access hospital in regard to
donation after cardiac death, if the OPO has a protocol for donation
after cardiac death. Second, at Sec. 486.328, we require that an OPO's
policies must state whether the OPO recovers organs from donors after
cardiac death. Finally, at Sec. 486.344, we require any OPO that
recovers organs from donors after cardiac death to have a protocol that
establishes the following: (1) Criteria for evaluating patients for
donation after cardiac death; (2) withdrawal of support, including the
relationship between the time of consent to donation and the withdrawal
of support; (3) the use of medications and interventions not related to
withdrawal of support; (4) the involvement of family members prior to
organ recovery; and (5) criteria for declaration of death and the time
period that must elapse prior to organ recovery. We have finalized
these requirements to facilitate our oversight of donation after
cardiac death, not specifically to encourage OPOs to recover organs
from cardiac dead donors. In addition, we are requiring an OPO to
address recovery and placement of organs from cardiac dead donors in
the protocols it establishes in collaboration with the transplant
hospitals in its service area. We expect OPOs to establish clear,
effective protocols that address the unique nature of donation after
cardiac death, include appropriate safeguards to protect the rights of
the potential donor and the family of the potential donor, and are
based on current technologies and practices in the field. We must
emphasize that these requirements do not mean that an OPO must recover
organs from donors after cardiac death. We understand that donation
after cardiac death is an evolving practice and is not yet accepted in
every area of the country. Some donor hospitals are reluctant to permit
donation after cardiac death in their facilities and some transplant
surgeons are unwilling to transplant organs from such donors into their
patients. Thus, some OPOs are hesitant to advocate donation after
cardiac death in their service areas.
Basis and Scope (Proposed Sec. 486.301)
In the February 4, 2005 proposed rule, our proposed basis and scope
was unchanged from the current regulations, except for adding a
reference to section 1102 of the Social Security Act and adding the
term, ``non-renewal'' to (b)(3) to clarify that the scope included the
non-renewal of the agreements OPOs' have with the Secretary.
We received no comments on this section of the proposed regulation.
However, upon review, we determined
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that Sec. 486.301(b)(4) needed to be revised. The existing section
includes a performance data cycle from January 1, 2002 through December
31, 2005. However, this time period has expired, and this final
regulation will be in effect for future re-certification cycles. We
have revised Sec. 486.301(b)(4) to clarify that the scope of the
subpart sets forth ``The requirements for an OPO to be re-certified.''
Further, we have added a reference to section 1871 of the Social
Security Act, which is listed as one of the authorities for part 486.
Definitions (Proposed Sec. 486.302)
To reflect organizational changes in the regulations text, to
remove obsolete material, and to provide further clarity to the
regulations, we proposed several amendments and additions to the
existing definitions in part 486. For a detailed discussion of our
proposed definitions, see the February 4, 2005 proposed rule. (70 FR
6089-6090)
Definitions Adopted as Proposed
We are finalizing the following terms and their definitions as
proposed: ``adverse event,'' ``death record review,'' ``designation,''
``donor,'' ``donor document,'' ``entire metropolitan statistical
area,'' ``open area,'' ``organ,'' and ``organ procurement
organization.'' Further discussion of the definition of ``adverse
event'' can be found in this preamble under ``Quality Assessment and
Performance Improvement (QAPI) (Proposed Sec. 486.348).''
Summary of Changes to Definitions Based on Public Comments
We have provided the following summary of changes to our proposed
definitions in response to public comments:
We revised the proposed definition of ``certification''
with minor clarifying changes that are discussed in this preamble under
``Certification (proposed Sec. 486.303).''
We revised the proposed definition of ``de-certification''
by removing language related to specific conditions, measures, and
requirements and revising it so that it is consistent with the
definition of ``certification.''
We have amended the proposed definition of ``designated
requestor'' by adding language to state that the terms a ``designated
requestor'' and ``effective requestor'' are interchangeable. These
terms are discussed more completely in the comments and responses in
this section.
We have revised the term ``service area'' to ``donation
service area (DSA),'' so that our terminology is consistent with the
terminology generally used and accepted in the OPO and transplant
communities. We have adopted the definition as proposed.
We have revised the proposed definition for ``re-
certification cycle'' to mean the 4-year cycle during which an OPO is
certified, because the OPO re-certification cycle is not based on the
calendar year in this final rule.
We are adding the following definitions to this final
rule: ``donor after cardiac death (DCD),'' ``eligible death,''
``eligible donor,'' ``expected donation rate,'' ``observed donation
rate,'' and ``standard criteria donor (SCD).'' These terms were not
proposed in our February 4, 2005 rule. Because we will be using data
from the OPTN and the SRTR in assessing whether OPOs have satisfied
these outcome measures, we are adopting the definitions currently used
by the OPTN and SRTR in their statistical evaluation of OPO
performance. Adopting these definitions should ensure their consistent
interpretation and application and promote the uniform and consistent
reporting of data to the OPTN. These definitions are integral to
understanding the new outcome measures in this final rule. A discussion
of the outcome measures, along with the public comments and our
responses can be found in this preamble under ``Section 486.318 Outcome
Measures.''
We have added the term ``donor after cardiac death (DCD),'' which
means an individual who donates after his or her heart has irreversibly
stopped beating. A donor after cardiac death also may be termed a non
heartbeating or asystolic donor.
The OPO Certification Act requires the Secretary to base both
outcome measures and process performance measures on ``organ donor
potential'' in each OPO service area. (See 42 U.S.C. 273.) We have
added the term ``eligible death,'' to replace the proposed terms
``organ donor potential'' and ``potential donor denominator.''
Commenters urged us to standardize the use of these terms to conform
them to the terms used by the OPTN and the SRTR. Therefore, we are
adopting the term ``eligible death.'' Although it is recognized that
this definition does not include all potential donors, for reporting
purposes for outcome measures performance assessment, an eligible death
for organ donation is defined as the death of a patient 70 years old or
younger, who ultimately is legally declared brain dead according to
hospital policy independent of family decision regarding donation or
availability of next-of-kin, independent of medical examiner or coroner
involvement in the case, and independent of local acceptance criteria
or transplant center practice, who exhibits none of the following:
Active Infections (Specific Diagnoses)
Bacterial
Tuberculosis.
Gangrenous bowel or perforated bowel and/or intra-abdominal sepsis.
Viral
HIV infection by serologic or molecular detection.
Rabies.
Reactive Hepatitis B Surface Antigen.
Retroviral infections including HTLV I/II.
Viral Encephalitis or Meningitis.
Active Herpes simplex, varicella zoster, or cytomegalovirus viremia
or pneumonia.
Acute Epstein Barr Virus (mononucleosis).
West Nile Virus infection.
Severe acute respiratory syndrome (SARS).
Fungal
Active infection with Cryptococcus, Aspergillus, Histoplasma,
Coccidioides.
Active candidemia or invasive yeast infection.
Parasites
Active infection with Trypanosoma cruzi (Chagas'), Leishmania,
Strongyloides, or Malaria (Plasmodium sp.).
Prion
Creutzfeldt-Jacob Disease.
General [Exclusions to the Definition of Eligible]
Aplastic Anemia.
Agranulocytosis.
Extreme Immaturity (<500 grams or gestational age of <32 weeks).
Current malignant neoplasms except non-melanoma skin cancers such
as basal cell and squamous cell cancer and primary CNS tumors without
evident metastatic disease.
Previous malignant neoplasms with current evident metastatic
disease.
A history of melanoma.
Hematologic malignancies: Leukemia, Hodgkin's Disease, Lymphoma,
Multiple Myeloma.
Multi-system organ failure (MSOF) due to overwhelming sepsis or
MSOF without sepsis defined as 3 or more systems in simultaneous
failure for a period of 24 hours or more without response to treatment
or resuscitation.
Active Fungal, Parasitic, viral, or Bacterial Meningitis or
encephalitis.
We have added the term ``eligible donor,'' which means any donor
that
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meets the eligible death criteria. The number of eligible donors is the
numerator for the donation rate outcome performance measure.
We have added the term ``expected donation rate,'' which the OPTN
defines as the rate expected for an OPO based on the national
experience for OPOs serving similar hospitals and donation service
areas. This rate is adjusted for the following hospital
characteristics: Level I or Level II trauma center, Metropolitan
Statistical Area size, CMS Case Mix Index, total bed size, number of
ICU beds, primary service, presence of a neurosurgery unit, and
hospital control/ownership, with an additional adjustment made for the
expected notification rate. This definition corresponds to the SRTRs'
definition of ``expected donation rate (hospital characteristics,
notification rate).'' We have added the term ``observed donation
rate,'' which is the number of donors meeting the eligibility criteria
per 100 deaths. The SRTR uses the expected donation rate and the
observed donation rate to calculate the SRTR-based donation rate, which
is one of the three outcome measures in this final rule.
We have added the term, ``standard criteria donor (SCD),'' which
means a donor who meets the eligibility criteria for an eligible donor
and does not meet the criteria to be a donor after cardiac death or
expanded criteria donor. Note that we are not including a definition of
``expanded criteria donor'' in this final rule because it is likely
that the OPTN and SRTR will change the criteria for expanded criteria
donor in response to changes in transplant technology.
We proposed that CMS can terminate an OPO in cases of ``urgent
need'' and we have finalized this proposal at Sec. 486.312(b). In
response to comments, we have added a definition for ``urgent need.''
Urgent need occurs when an OPO's noncompliance with one or more
conditions for coverage has caused, or is likely to cause, serious
injury, harm, impairment, or death to a potential or actual organ donor
or an organ recipient. Discussion of the definition can be found in
this preamble under ``De-Certification (proposed Sec. 486.312).''
Following is a summary of the public comments we received on our
proposed definitions, along with our responses to the comments.
Comment: Several commenters noted that the term ``designated
requestor'' is no longer used in the organ donation community.
Commenters said that under the Collaborative, OPOs and hospitals refer
to the person who fulfills the ``designated requestor'' role as an
``effective requestor,'' and they urged us to adopt this term in the
final OPO regulation. Some commenters said that hospitals are concerned
that they may be cited by surveyors if their records show an
``effective requestor'' was involved in the consent process rather than
a ``designated requestor.''
Response: Under the Collaborative, an ``effective requestor'' is an
individual who has demonstrated effectiveness and expertise in
requesting donation from families of potential donors. The individual
may be an OPO employee or hospital employee or another individual and
may have received formal classroom training in requesting organs or
less formal education and guidance from OPO staff. The person who will
be the most effective requestor varies, depending upon the family and
the specific donation situation. We will continue to use the term
``designated requestor'' because the hospital condition of
participation (CoP) for organ, tissue, and eye procurement at Sec.
482.45 includes the term ``designated requestor.'' However, we have
revised the definition in Sec. 486.302 to clarify that we regard the
terms ``designated requestor'' and ``effective requestor'' to be
interchangeable.
Comment: Many commenters said that there should be both a
standardized definition of ``organ donor potential'' (termed ``eligible
deaths'' by the OPTN and SRTR) as well as consistent and uniform
application of that definition throughout the OPO community. As some
commenters pointed out, we proposed using outcome measures data
submitted to the OPTN for re-certifying OPOs. However, the proposed
definition for
``organ donor potential'' in the February 4, 2005 rule was not
consistent with OPTN's definition of ``eligible deaths'' or ``eligible
donors.'' A national organization stated that different definitions,
may ``cause confusion in the field and lead to mistakes and
inaccuracies.'' However, the national organization submitted a
recommended definition of ``organ donor potential'' that is different
both from our proposed definition, as well as from the OPTN's
definition of ``eligible death.''
Response: We agree that for the data to be accurate and
consistently reported, the terms and definitions should be standardized
to the greatest extent possible. Based on the public comments that
emphasized the importance of uniform and consistent reporting of organ
donor potential to the OPTN, we are adopting the OPTN term ``eligible
deaths'' and its definition, instead of the proposed term ``organ donor
potential'' and its proposed definition. We believe that other
provisions in this final rule, specifically, the requirements for death
record reviews and reporting data, also will promote the consistent
interpretation and application of ``eligible deaths.''
Comment: Most comments we received on the definitions concerned the
definition of ``organ donor potential.'' Most of these comments were
favorable, with many commenters saying that they were pleased with the
shift away from ``donors per million population'' to our emphasis on
``organ donor potential.'' Some indicated that the proposed definition
is a far superior method of defining ``donor potential'' than the
previous ``donors per million population.''
Response: We appreciate the support expressed by commenters for
basing OPO outcome measures on the organ donor potential in an OPO's
service area, rather than continuing to use a population-based
approach, and we agree that it will be a more accurate measure of the
donor potential in a DSA. As stated previously, we are using the term
``eligible deaths'' instead of ``organ donor potential'' because it is
consistent with the OPTN and SRTR definition.
Comment: Two commenters were supportive of the exclusion of donors
after cardiac death (DCDs) from the definition of ``organ donor
potential.'' One commenter said that ``DCD organs are still
experimental'' and that there needs to be ``more scientific facts and
long-term follow-up before we can honestly assure our patients that
utilization of these kidneys is in their best interest long-term.''
Another commenter noted that DCDs only represented 5 percent of the
organs recovered in 2004. The commenter also noted that the recovery
and transplantation of organs from DCD organs is not a common practice
throughout the United States. The commenter said it would be premature
to include DCDs in the standardized definition of ``organ donor
potential.'' However, one commenter encouraged us to include DCDs in
the potential donor pool.
Response: Although the number of DCD organs recovered and
transplanted has increased significantly in recent years, we
acknowledge that the procurement and transplantation of DCD organs is
not a common practice throughout the United States and that some
surgeons have concerns about using these organs. The OPTN's current
definition of ``eligible deaths'' does not include DCDs, and we are
using the OPTN definition in this final rule. DCDs will be discussed
further in this preamble under ``Donor Evaluation and
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Management and Organ Placement and Recovery (proposed Sec. 486.344).''
Comment: One OPO was concerned about our including specific
exclusionary criteria in the definition of ``organ donor potential.''
That commenter noted that changes to the definition ``would require a
change through regulatory process.'' This commenter suggested we refer
to the United Network for Organ Sharing's (UNOS) definition and
``designate their guidelines as the clinical indications for OPOs to
follow.'' (Note that UNOS is the Federal contractor that currently
administers the OPTN.)
Response: To be enforced by CMS, rules and requirements of the OPTN
(that is OPTN policies and bylaws, which include definitions of
terminology used by the OPTN and its members) must be approved formally
by the Secretary by being published in the Federal Register with an
opportunity for the public to comment. However, no policy or bylaw of
the OPTN has been approved by the Secretary in this manner. In most
instances, we must include the specific language of the OPTN policy or
bylaw in order to make it a requirement.
We acknowledge that because we are including some of the
definitions used by the OPTN and SRTR, we may need to make changes to
our definitions through future rulemaking if the OPTN and SRTR change
their definitions. We will be monitoring these changes as they occur
and will undertake further rulemaking if necessary.
Comment: Two commenters noted that the ``organ donor potential''
guidelines offered in the February 4, 2005 proposed rule would not
cover all of the potential donor situations. One commenter suggested
that there be some type of forum in which questionable cases could be
presented and ``an opinion rendered'' as to whether or not it is a
reportable ``eligible death.''
Response: We agree that the definition of ``eligible death'' may
not cover all potential donor situations. We will work with HRSA to
determine whether a procedure can be established to assist OPOs that
are unsure whether a particular potential donor situation should be
characterized as an ``eligible death.''
Comment: Two commenters recommended that we modify the definition
of ``donor'' to include pancreata procured for islet cell
transplantation or research pursuant to the requirements of the
Pancreatic Islet Cell Transplantation Act of 2004 (Pub. L. 108-362).
Response: The Pancreatic Islet Cell Transplantation Act of 2004
states that ``* * * [p]ancreata procured by an organ procurement
organization and used for islet cell transplantation or research shall
be counted for purposes of certification or re-certification.'' We have
chosen not to modify the definition of ``donor'' in Sec. 486.302
because there is nothing in the definition that precludes us from
counting pancreata used for islet cell treatment for re-certification
of OPOs. However, we are making other changes to the certification
process to comply with this statute. We will count pancreata recovered
for use in islet cell transplantation and research in the organs
transplanted per donor and organs used for research per donor yield
measure in this final rule. Outcome measures for pancreata used for
islet cell transplantation and research are discussed in more detail in
this preamble in the ``Outcome Measures section (proposed Sec.
486.318).''
Requirements for Certification (Proposed Sec. 486.303)
In Sec. 486.303, we proposed requirements that an OPO must meet to
be certified. We proposed that an OPO must: Have received a grant under
42 U.S.C. 273(a); be a non-profit entity that is exempt from Federal
income taxation under section 501 of the Internal Revenue Code of 1986;
have accounting and other fiscal procedures necessary to assure the
fiscal stability of the organization, including procedures to obtain
payment for kidneys and non-renal organs provided to transplant
hospitals; have an agreement with the Secretary to be reimbursed under
title XVIII for the procurement of kidneys; have been re-certified as
an OPO under the Medicare program from January 1, 2002 through December
31, 2005; have procedures to obtain payment for non-renal organs
provided to transplant centers; agree to enter into an agreement with
any hospital or critical access hospital in the OPO's service area,
including a transplant hospital, that requests an agreement; and, meet
or have met the conditions for coverage, including the outcome measures
and the process performance measures.
We received few comments that specifically related to these
proposed provisions. However, we requirements in Sec. 486.303 as a
result of revisions we made to the designation requirements in Sec.
486.304 and to the de-certification requirements in Sec. 486.312,
based on comments on the proposed de-certification process. A detailed
discussion of the changes to our proposed de-certification requirements
are discussed in the preamble section that addresses Sec. 486.312.
Comment: Commenters stated that the proposed requirement that an
OPO must ``have a grant under 42 U.S.C. 273(a)'' as a requirement for
certification is inaccurate and conflicts with the preamble language
(page 6086, column 3, paragraph 3), 42 U.S.C. 1320B-8(b)(1)(A), and
proposed Sec. 486.303(a). They said that section 1320B-8(b)(1)(A) of
the statute clearly provides that an OPO is qualified if it has
received a grant or is otherwise certified by the Secretary. Commenters
stated that the preamble correctly reflects the statutory requirement,
but the proposed requirement does not. Commenters further stated that
the proposed requirement at Sec. 486.303(a) seems to make it a
mandatory requirement instead of an alternative requirement.
Response: We agree with the commenters that 42 U.S.C. 1320B-
8(b)(1)(A) includes an alternative requirement. Therefore, we are
revising Sec. 486.303(a) to state that in order to be certified as a
qualified OPO, an OPO must have received a grant under 42 U.S.C. 273(a)
or have been certified or re-certified by the Secretary within the
previous 4 years as being a qualified OPO.
Requirements for Designation (Proposed Sec. 486.304)
The existing regulations include requirements for designation of
OPOs in two separate sections: Sec. 486.304 and Sec. 486.306. We have
revised Sec. 486.304 by moving some requirements to other sections of
the rule. For a list of the organizational changes, see our crosswalk
in section III--``Provisions of the final rule.'' For a detailed
discussion of our proposed provisions for Sec. 486.304, see the
February 4, 2005 proposed rule (70 FR 6131.)
Only one comment was received on our proposed provisions in Sec.
486.304. However, we received many comments containing major concerns
about the de-certification requirements in Sec. 486.312. The revisions
that we made to Sec. 486.312 based on the comments resulted in changes
to Sec. 486.304. (See the comments and responses in this preamble
under ``De-Certification (proposed Sec. 486.312)'' for a discussion of
these changes.) Following is a summary of the comment on proposed Sec.
486.304 and our response.
Comment: One commenter stated that to compete for an open area,
OPOs should be required to meet all five, instead of only four of the
outcome measures. The commenter stated that such a requirement would be
helpful in addressing the concern that these outcome measures would
create an incentive for OPOs to procure as many
[[Page 30987]]
organs as possible, including organs from extended criteria donors
(ECDs) and donation after cardiac death (DCD) donors, regardless of
whether they can be transplanted, and without considering graft and
recipient outcomes.
Response: In this final rule, requirements for choosing an OPO when
a donation service area is open have been moved to Sec. 486.316 and
revised in the context of the re-certification and competition
processes in this final rule. In response to comments, we are changing
the outcome measures significantly, as well as the standards for an OPO
to compete for an open area. To be re-certified, an OPO is required to
meet all three of the outcome measures in this final rule. A complete
discussion of these competition standards can be found in ``Re-
Certification and Competition Processes (proposed Sec. 486.316)'' in
this preamble.
OPO Service Area Size Designation and Documentation Requirements
(Proposed Sec. 486.306)
We proposed several changes to the requirements in this section. We
proposed that OPOs would no longer be required to provide population
data to us since population would no longer be used as a basis for OPO
certification. Although, we proposed retaining the requirement that an
OPO must procure organs from an average of at least 24 donors per
calendar year, we proposed changing the current requirement for an
average of 24 donors per calendar year in the 2 years before the year
of re-designation to a requirement for an average of 24 donors per
calendar year in the 4 years before the year of re-designation because
the re-certification cycle has been increased from 2 years to 4 years.
We proposed no longer permitting exceptions to the 24-donor per year
rule.
Additionally, we proposed removing obsolete service area size
standards for periods during 1996 and before. Finally, we proposed
increasing the designation period from 2 years to 4 years to conform
the designation period to the re-certification cycle.
Following is a summary of the comments we received and our
response.
Comment: Some commenters recommended that CMS continue to allow an
exception to the 24-donor requirement for Hawaii. One commenter pointed
out that Hawaii is an island State that has only one hospital that
performs transplants (kidney, liver, pancreas, and heart). In addition,
the commenter stated that the next closest transplant center is 2000
miles away on the mainland. Furthermore, there are few transplant
surgeons in Hawaii and only one each for heart, liver, and pancreas.
The commenter noted that if these surgeons are out of State, certain
organs are not recovered because they cannot be transplanted.
Response: After reviewing the comments on this proposed provision,
we considered retaining the 24-donor rule with an exception for an OPO
whose service area includes Hawaii and does not include any part of the
continental United States. However, OPOs on average now recover 130
donors per year. We believe it is unlikely that any OPO other than
Hawaii would have difficulty surpassing the 24-donor threshold.
Further, because of the unique challenges presented by recovering and
placing organs so far from the mainland, we believe we would be likely
to grant an exception to Hawaii if it failed to achieve the 24-donor
threshold. Therefore, we have concluded that the 24-donor rule is no
longer useful or necessary as a measure of the ``sufficient size'' of
an OPO service area. We have revised this final rule accordingly by
removing the 24-donor-per-year requirement.
Comment: One commenter stated that OPOs should be designated in a
manner that optimizes organ recovery and allocation. The commenter
pointed out that service areas have developed over the years in a
manner that may not yield the best results and urged CMS to develop a
long-term vision for a logical and productive way to divide the country
among OPOs, using either a statewide system or a system reflecting
optimal allocation units, based on research. The commenter predicted
that such systems would make comparisons between OPOs more meaningful
and urged CMS to use the final rule (CMS-3064-F) to move toward that
goal.
Response: We appreciate the comment; however, we are unaware of any
definitive research that would guide us in re-drawing the boundaries of
the present OPOs in a manner that is both consistent with the statute
and more likely to yield better results. Furthermore, based on our
experience, we believe any attempt to implement a system that would
require us to remove territory from one OPO's service area to give it
to another OPO would result in confusion that could negatively impact
organ donation.
We received no comments on our other proposals under this section.
We proposed removing the language from the existing regulations at
Sec. 486.307(d)(2)(iv) that requires an entity to show that it can
procure organs from at least 50 potential donors per year if it was not
previously designated as an OPO. We also proposed removing references
related to designation of requirements for entities or organizations
that are not currently OPOs. No commenters opposed this change, and we
have adopted it as proposed.
We proposed a number of other relatively minor changes to the
existing Sec. 486.307. We proposed removing obsolete service area size
standards for periods during 1996 and before. We proposed changing the
current requirement that OPOs must submit information about acute care
hospitals in their service areas that have an operating room and the
equipment and personnel to retrieve organs, to a requirement that OPOs
submit information about hospitals that have both a ventilator and an
operating room (because in proposed Sec. 486.320, we proposed
requiring OPOs to have agreements with 95 percent of such hospitals).
Finally, we proposed increasing the designation period from 2 years to
4 years to conform the designation period to the re-certification
cycle. Because we received no public comments on these changes, we are
adopting them as proposed.
Designation of One OPO for Each Service Area (Proposed Sec. 486.308)
We proposed no substantive changes to the current Sec. 486.316,
``Designation of one OPO for each service area,'' with the exception of
replacing the ``tie-breaker'' criteria used to designate an OPO when
two or more OPOs apply for the same area. We did, however, propose re-
locating these criteria to Sec. 486.316 (``Re-certification and
Competition Processes''). In addition, Sec. 486.308(b) through Sec.
486.308(f) has been re-designated as Sec. 486.308(c) through Sec.
486.308(g) and Sec. 486.308(b) has been added. Newly added paragraph
(b) was relocated from Sec. 486.304(c) as part of our reorganization
and clarification in this final rule of the sections that address
certification and designation.
We received public comments about the process for a hospital to
seek a waiver to work with an alternate OPO, even though we did not
propose changing these regulations. Under section 1138(a)(2)(A) of the
Social Security Act and the OPO regulations at 42 CFR 486.316(e)
through (g), a hospital may request and CMS may grant a waiver
permitting the hospital to have an agreement with a designated OPO
other than the OPO designated for the service area in which the
hospital is located. To qualify for a waiver, the hospital must submit
data to CMS
[[Page 30988]]
establishing that: (1) The waiver is expected to increase organ
donations; and (2) the waiver will ensure equitable treatment of
patients referred for transplants within the service area served by the
hospital's designated OPO and within the service area served by the OPO
with which the hospital seeks to enter into an agreement.
In making a determination on a request, CMS may consider: (1) Cost
effectiveness; (2) improvements in quality; (3) changes in a hospital's
designated OPO due to changes in the metropolitan statistical area
designations, if applicable; and (4) the length and continuity of a
hospital's relationship with an OPO other than the hospital's
designated OPO.
A hospital may continue to operate under its existing agreement
with an out-of-area OPO while CMS is processing the waiver request. If
a waiver request is denied, a hospital must enter into an agreement
with the designated OPO within 30 days of notification of the final
determination.
Comment: A few commenters recommended that we clarify ``appropriate
purposes'' for waivers to avoid attempts at ``cherry picking'' or at
influencing organ allocation patterns without considering patient
access to organs. The commenters' recommended criteria would require a
hospital to have certain organ donation policies and procedures in
place before being eligible to apply for a waiver and would require CMS
to take factors into consideration that are not included in the statute
or in current regulations. One commenter said that there should be a
presumption against creation of new waivers. The commenter recommended
that the burden of proof for a hospital to show that it should receive
a waiver to work with a different OPO should be high, and a waiver
should be granted only if CMS finds a ``material deficiency.'' Another
commenter said that the waiver program should emphasize improved
outcomes.
Commenters recommended that to seek a waiver to work with an
alternate OPO, a hospital should be required to: (1) Have written
policies and procedures to address its organ procurement
responsibilities; (2) document that the hospital's governing body has
approved the hospital's organ procurement policies; (3) integrate the
organ, tissue, and eye donation program into the hospital's quality
assessment and performance improvement (QAPI) program; and (4) have
policies to ensure that potential donors are identified and declared
deceased within an acceptable time frame by an appropriate
practitioner.
Commenters also recommended that we incorporate a variety of
additional considerations in our review process to determine whether to
grant a waiver, such as the outcome of the most recent Joint Commission
on Accreditation of Healthcare Organization's (JCAHO) review of the
hospital's accreditation status and whether the hospital has policies
and procedures in place so that any failure to identify a potential
organ donor and/or refer such a potential donor to the OPO in a timely
fashion would be investigated and reviewed by the hospital in a manner
similar to that for other major adverse healthcare events.
Response: The waiver request process is open and transparent. By
statute, we publish all pertinent information in a Federal Register
Notice, giving the OPOs involved in the request and the public an
opportunity to comment. Generally, we approve the request if the
hospital requesting the waiver can demonstrate that the waiver is
expected to increase organ donation and that the waiver will ensure
equitable treatment of patients referred for transplants within the
service area served by the hospital's designated OPO and within the
service area served by the OPO with which the hospital seeks to enter
into an agreement.
Some of the commenters' recommendations for factors we should
consider when making a decision on a waiver request currently are
requirements hospitals must meet to participate in Medicare. Thus,
adding these requirements to the waiver process would be duplicative.
Other recommendations made by the commenters currently are not
requirements hospitals must meet to participate in Medicare. We do not
believe it would be fair to expect a hospital to meet requirements that
fall outside the Medicare hospital conditions of participation in order
to receive a waiver to work with an alternate OPO.
While we appreciate the comments, the commenters' recommendations
would slow the waiver process and make it more difficult for hospitals
to obtain a waiver. We believe making these changes in the process
could harm organ donation by forcing a hospital to continue to
participate in a difficult and unproductive relationship with an OPO
and would weaken an incentive OPOs now have to provide superior
services to the hospitals in their service areas. We are not adopting
any of the suggested changes, which would appear to add additional
burdens on hospitals and seem to be intended to discourage a hospital
from exercising the rights that the Congress provided in section 1138
of the Social Security Act.
Re-Certification From August 1, 2006 Through July 31, 2010 (Sec.
486.309)
We included language in our February 4, 2005 proposed rule for a
time period that has now expired. Under this final rule, the first re-
certification cycle for the 58 OPOs is August 1, 2006 through July 31,
2010. We are revising the language in Sec. 486.309 accordingly.
Comment: Many commenters stated that they understood that the
proposed outcome measures would not be applied retrospectively for the
period of time from January 1, 2002 to December 31, 2005. Many other
commenters wrote to us urging that the proposed performance measures
not be applied retrospectively, and they urged us to establish a
transition period before implementing any performance measures that
would be contained in a final rule. Prior to publication of the
February 4, 2005 proposed rule, many individual OPOs and their national
association contacted us to express their concerns about the impending
expiration of their certifications and to urge us to take action to
ensure that OPOs would continue to be certified so there would be no
disruption in service. A commenter noted, ``The timing of these
proposed regulations (given the passage of the legislation in 2000)
creates the need for an interim course of action.'' Another commenter
stated, ``we are now in the 41st month of a 48 month review process.''
Response: We agree with these commenters that the proposed
performance measures should not be applied to evaluate an OPO's
performance for the period of January 1, 2002 to December 31, 2005. As
discussed earlier in this preamble, after careful deliberation
concerning how to re-certify the existing 58 OPOs for the next re-
certification cycle, we have decided that the most prudent course of
action is to re-certify all existing OPOs from August 1, 2006 through
July 31, 2010 and offer to extend their agreements with the Secretary
through January 31, 2011, so that OPOs can maintain their present organ
procurement functions. Therefore, we have revised Sec. 486.309
accordingly.
Changes in Ownership or Service Area (Proposed Sec. 486.310)
In Sec. 486.310, we proposed that a designated OPO considering a
change in ownership or in its service area must notify CMS before
putting it into effect. In addition, we proposed that if CMS finds that
the OPO has changed to such an extent that it no longer satisfies the
[[Page 30989]]
requirements for OPO designation, CMS may de-certify the OPO and
declare the OPO's service area to be an open area. The proposed
provisions in this section were based on existing regulations.
We received only a few comments on this section, which are
summarized below.
Comment: One commenter said that control, not ownership, is
relevant to nonprofit corporations. The commenter recommended that we
add the word ``control'' and a definition to paragraph (a).
Response: We appreciate the commenter's recommendation. Since all
OPOs must be non-profit, we have added the word ``control'' to Sec.
486.310(a) to clarify that this section applies to changes in the
control over an OPO, as well as changes in ownership or in an OPO's
service area. The term ``control'' is defined in Sec. 413.17(b)(3),
and we have added a cross reference in the regulations text for this
final rule.
Comment: A commenter noted that this section does not contain a
time frame within which we must make our decision to approve a change
of ownership. The commenter suggested that we should require the OPO to
provide 15 or 30 days notice of the impending change to us and that we
should make our determination within 30 days of receipt of the
information we request. The commenter said that this time frame would
eliminate the uncertainty of a possible CMS challenge under paragraph
(b) and would not hold up the consummation of a change of ownership or
control transaction.
Response: We appreciate the comment. We will make a decision as
soon as practical after receiving all the information we request from
the OPO. However, every case is different, and it is not possible for
us to specify a time frame within which we are able to make a decision.
Comment: A commenter stated that the information that we require
under paragraph Sec. 486.310(a)(2) should be only that information
which is required for designation.
Response: The circumstances surrounding each change of ownership or
merger are different, which may create the need for additional
information. Thus, we have retained the language in (a)(2), which
specifies that we may require ``other written documentation CMS
determines to be necessary for designation.''
De-Certification (Proposed Sec. 486.312)
We proposed de-certification requirements based on voluntary or
involuntary termination of an agreement or non-renewal of an agreement.
For a detailed discussion of our proposed provisions, see the February
4, 2005 proposed rule (70 FR 6086).
We did not receive any comments on our proposed requirements for
Sec. 486.312(a) De-certification due to voluntary termination of
agreement. Therefore, we made only a few minor conforming changes in
the final rule.
In contrast, commenters expressed concerns regarding the two
proposed involuntary de-certification process provisions at Sec.
486.312(b), De-certification due to involuntary termination of
agreement (that is, during the term of the agreement), and at Sec.
486.312(c), Non-renewal of agreement (that is, at the end of the term
of the agreement). Therefore, we have made revisions to Sec.
486.312(b) and (c). We did not receive comments regarding Sec.
486.312(e) Public notice. Therefore, we made only one minor clarifying
edit in that subsection of the final rule.
Comment: Commenters stated that the statute requires that re-
certification (and by inference de-certification) decisions be based on
multiple outcome and process performance measures. Commenters stated
that based on the proposed involuntary de-certification processes, an
OPO could be de-certified based on non-compliance with a single
certification requirement or, if it complies with all of the
certification requirements, a single designation requirement.
Commenters expressed concerns that the proposed Sec. 486.312(b), De-
certification during the term of the agreement, and Sec. 486.312(c),
De-certification due to non-renewal of agreement, permit de-
certification based upon considerations not authorized by the OPO
Certification Act.
Response: We disagree with the commenter's premise. The OPO
Certification Act requires the Secretary to establish ``multiple
outcome measures as part of the certification process,'' and we are
doing so. However, the Organ Procurement Organization Act did not
define the terms ``certification,'' ``re-certification,'' or ``de-
certification.'' Moreover, the Congress did not suggest that an OPO
could not be de-certified if the OPO violated other regulatory
conditions of coverage, such as failure to ensure that donors are
tested for human immunodeficiency viral markers. Nothing in the
legislative history suggests that the Congress intended to continue to
pay an OPO that violated such a condition for coverage. Rather, the
legislative history suggests that the Congress was concerned with end-
of-cycle de-certifications caused by an OPO's failure to meet the
performance standards established at Sec. 486.310, and that were
expressly authorized under section 1138(b)(1)(C) of the Social Security
Act.
The congressional findings indicated a concern that the
certification process had ``created a level of uncertainty'' that was
interfering with the OPOs' effectiveness in raising the level of organ
donation. We have addressed those concerns in this final rule by
establishing, among other things: (1) A re-certification process that
relies on outcome and process performance measures based on empirical
evidence of organ donor potential in an OPO's service area, (2)
multiple outcome measures, (3) rules that clearly delineate the steps
in the appeals process for de-certifications, and (4) rules that delay
the competition phase until the administrative appeals process has been
completed. Therefore, this final rule is fully consistent with the
statutory requirements.
Comment: Commenters expressed concern that the proposed de-
certification requirements at Sec. 486.312(b) and Sec. 486.312(c) are
inconsistent with the proposed definition of ``de-certification;'' and
with the certification requirements. In addition, commenters expressed
concern about inconsistency with the substantive grounds for de-
certification proposed at Sec. 486.312(b), as well as the fact that
CMS provided no explanation for this disparity. Commenters stated that
the grounds for de-certification should be consistent, or the
administrative record should indicate the legal and policy reasons as
to why they differ. Commenters stated that this provision permits non-
renewal of an agreement based on only one criterion, that is, failure
to meet the outcome measures. Commenters stated that a de-certification
is a terminal action that we should make only after review of all
relevant criteria, not simply based on simple arithmetic outcome
measures that automatically trigger a de-certification decision.
Commenters recommended that Sec. 486.312(b) should be changed to
read as follows: ``Decertification due to involuntary termination of
agreement. The Secretary may terminate an agreement with an OPO if CMS
finds that the OPO no longer meets the requirements for certification
in Sec. 486.318. CMS may also terminate an agreement immediately in
cases of urgent need, such as the discovery of unsound medical
practices. CMS will decertify the OPO as of the effective date of the
involuntary termination.'' Commenters recommended that Sec. 486.312(c)
be deleted.
[[Page 30990]]
Response: We agree with some but not all of the commenters'
suggestions. As mentioned earlier, we have redefined ``de-
certification'' and the requirements for certification in Sec.
486.303. We also agree that OPOs can be de-certified during the 4-year
re-certification cycle for many reasons, including situations where
there is an urgent need. However, we do not agree that it is necessary
or prudent to combine sections (b) and (c), as one commenter suggested,
because the effective dates of a de-certification are not necessarily
identical. We are making changes to the final rule to clarify that de-
certification due to involuntary termination of an agreement occurs
``during the term of the agreement.'' We have streamlined and clarified
the provision by deleting the language that refers to termination if
the OPO no longer meets the requirements ``for designation, or
certification or the conditions for coverage in this subpart or is not
in substantial compliance with any other applicable Federal regulations
or provisions of titles XI, SVIII, or XIX of the Act.'' In its place,
we have inserted language that refers to termination if the OPO no
longer meets the requirements for ``certification at Sec. 486.303.''
We have also made minor edits to the title. We have revised Sec.
486.312(b) as follows:
Involuntary termination of agreement. During the term of the
agreement, CMS may terminate an agreement with an OPO if the OPO no
longer meets the requirements for certification at Sec. 486.303. CMS
may also terminate an agreement immediately in cases of urgent need,
such as the discovery of unsound medical practices. CMS will de-certify
the OPO as of the effective date of the involuntary termination.
We have not deleted proposed Sec. 486.312(c) as commenters
suggested. We do not agree with the commenters that by de-certifying an
OPO that fails to meet the outcome measures, we would be basing the
OPO's de-certification solely on a single arithmetic computation. At
the end of the re-certification cycle, we will determine each OPO's
performance on the multiple outcome measures that we believe reflect
the entire spectrum of an OPO's performance. Moreover, we expect every
OPO to evaluate and improve its practices throughout the re-
certification cycle to ensure that by the end of the cycle, it meets
all of the measures. If it has not, we believe it is appropriate to de-
certify the OPO. Holding all OPOs accountable for meeting all three
outcome measures will provide a strong incentive for OPOs to excel. We
believe this incentive will increase organ donation in the United
States.
Further, we expect OPOs to be in compliance with all the process
performance measures and other regulatory conditions at all times. We
will survey each OPO at some point during the re-certification to
evaluate its compliance with the process performance measures and, if
the OPO is out of compliance, to give the OPO an opportunity to come
back into compliance through a plan of correction. Therefore, by the
end of the re-certification cycle, all OPOs must be in compliance with
the process performance measures and other regulatory conditions. If an
OPO is not in compliance with the process performance measures and the
other requirements at Sec. 486.303 at the end of the re-certification
cycle, we may De-certify the OPO at that time. Therefore, we have added
language to clarify that non-renewal of an OPO's agreement is based on
failure to meet the outcome measures or failure to comply with the
other requirements for certification.
For the purpose of clarification, we have removed our proposed
language in Sec. 486.312(c), ``or if the OPO's designation status has
been terminated'' because we streamlined the requirement by including
most of the proposed requirements for designation in Sec. 486.303.
Based on public comments, we have revised Sec. 486.312(c)in the final
rule as follows:
``Non-renewal of agreement. CMS will not voluntarily renew its
agreement with an OPO if the OPO fails to meet the outcome measures at
Sec. 486.318, based on findings from the most recent re-certification
cycle, or any of the other requirements for certification at Sec.
486.303. CMS will de-certify the OPO as of the ending date of the
agreement.''
Comment: One commenter stated that the phrase ``urgent need'' in
Sec. 486.312(b) needs a more detailed definition. The commenter said
that the proposal identifies only the discovery of ``unsound medical
practices,'' but there is no sense of the severity of the unsound
medical practices. The commenter recommended that the definition of
``urgent need'' should include an ``imminent and incurable threat to
public safety, to donors, or a material failure of governance,
management, or recovery practices and procedures which imminently
threaten public safety and which cannot be or which are not likely to
be cured by or with the cooperation of the OPO.''
Response: We agree that the phrase ``urgent need'' requires a more
detailed definition. To help us address this issue, we looked to the
definition of ``immediate jeopardy'' contained in the requirements for
provider agreements and supplier approval at Sec. 489.3, which states,
``For the purposes of this part--Immediate jeopardy means a situation
in which the provider's noncompliance with one or more requirements of
participation has caused, or is likely to cause, serious injury, harm,
impairment, or death to a resident.'' We modified this definition for
OPOs and added the definition of ``urgent need'' at Sec. 486.302 as
follows, sbull I11``Urgent need occurs when an OPO's noncompliance with
one or more conditions for coverage has caused, or is likely to cause,
serious injury, harm, impairment, or death to a potential or actual
organ donor or organ recipient.'' For example, we would consider an
OPO's failure to ensure that appropriate donor screening and testing
are completed to be a situation of ``urgent need.''
Comment: One commenter stated that in the proposed Sec.
486.312(d), if the 90-day notice is to be given for de-certification at
a time other than at the end of a de-certification cycle, there are no
standards set forth to justify why that notification should occur at a
time other than at the end of a cycle. The commenter stated that if it
were an emergent situation, the other provisions of the proposed
section for a termination with no less than 3-days notice would apply.
The commenter further stated that the regulations should clarify why a
notice of de-certification will be given at a time other than the end
of the certification cycle and explain how the giving of notice before
the end of the cycle may impact an OPO's right of appeal. Finally, the
commenter recommended that the regulation require that any notice of
de-certification contain an explanation of the grounds for such de-
certification.
Response: We agree with the commenters that additional information
should be added to the final rule. Under the final rule at Sec.
486.312(b) we may de-certify an OPO based on termination of the
agreement during the term of the agreement for failure to meet the
requirements for certification at Sec. 486.303. For example, if an OPO
is substantially out of compliance with one or more process performance
measures and fails to submit or implement an acceptable plan of
correction, we would terminate the OPO's agreement and de-certify the
OPO. We may de-certify an OPO at the end of the 4-year agreement based
on non-renewal of the agreement for failure to meet the outcome
measures at Sec. 486.318 or the other requirements for certification
at Sec. 486.303. Except in cases of urgent need, CMS is required to
[[Page 30991]]
give written notice of de-certification to an OPO at least 90 days
before the effective date. In cases, of urgent need, CMS gives written
notice of de-certification at least 3 calendar days before the
effective date of the de-certification. This written notice will
include all the reasons for de-certification. (See Sec. 486.314(a).)
In summary, our intent is not to de-certify OPOs unnecessarily but
to ensure that OPOs maximize the recovery of viable organs for
transplantation and provide high quality care to families of potential
donors, and provide efficient, effective services to transplant
hospitals. However, if an OPO does not comply with the regulations, it
will face enforcement actions during the agreement cycle, as well as at
the end of the cycle. Revisions have been made in response to public
comments that affect multiple requirements at Sec. 486.302,
Definitions; Sec. 486.303, Requirements for certification; Sec.
486.304, Requirements for designation; and Sec. 486.312, De-
certification. These revisions in the final rule clarify and streamline
the regulations and comprehensively address commenters' concerns
regarding internal inconsistency of the regulations.
Appeals (Proposed Sec. 486.314)
To address the congressional mandate for an appeals process for
OPOs to appeal a de-certification on substantive and procedural
grounds, we proposed to streamline the appeals process so that an OPO
facing de-certification could appeal and receive a decision on its
appeal before we opened its service area for competition from other
OPOs. Specifically, we proposed to delay competition until an
administrative appeal was completed; expedite appeals by using a CMS
hearing officer; and, at our discretion, extend the appellant OPO's
agreement for 60 days to complete the appeals and competition processes
and, if necessary, select a new OPO to take over the appellant OPO's
service area.
In the final rule, we expand the circumstances under which an OPO
can appeal a de-certification due to involuntary termination or non-
renewal of its agreement with us, and the process will enable OPOs to
appeal on both substantive and procedural grounds. We establish an
appeals process that includes procedures for OPOs to request
reconsideration and to request a hearing. To avoid undue procedural
delays, the final rule also establishes certain specific time frames
for both the appellant OPO, the reconsideration official, and the CMS
hearing officer. Further, in response to public comments, we have
expanded the proposed appeals process to grant OPOs certain additional
appeal rights.
We received many comments on the appeals process; no comments were
positive. Many commenters said that they prefer the part 498 process,
which sets forth procedures for providers and suppliers to appeal
decisions that affect participation in the Medicare program. Some
commenters argued that the Secretary is required to provide the part
498 process to OPOs.
However, the same commenters indicated that if we did not reinstate
the part 498 process for OPO appeals, they would be satisfied with a
specific alternative process utilizing a CMS hearing officer to hear
appeals. The commenters described the process, which would include some
part 498 procedures, such as the right to a reconsideration. Commenters
said that regardless of what appeals process is included in the final
rule, they want more detail about how the process will work. We have
added such detail throughout our responses to the comments. Following
is a summary of the public comments we received, along with our
responses.
Comments on the Part 498 Process
Comment: Commenters said that the Secretary has consistently
provided OPOs with the appeal rights outlined in 42 CFR part 498. They
said that even before the OPO Certification Act, the statutory and
regulatory language demonstrates that for purposes of appeals, OPOs
were entitled to the same or an equivalent process to that of ESRD
facilities (which were entitled to appeal under part 498). Commenters
suggested that the Secretary's inclusion of OPOs in the part 498
hearing procedures was based on statutory obligations and was not
discretionary. Commenters said that CMS must provide either the part
498 hearing or a process that is equivalent to the part 498 process.
They stated that the OPO Certification Act underscored this obligation
by including new language specifically addressing the appeal rights of
OPOs and requiring the right to appeal on ``substantive and procedural
grounds.'' Commenters also noted that the proposed appeals process is
inconsistent with the intent of the Congress, which, in enacting the
OPO Certification Act, clearly relied on the Secretary's prior
designation of OPOs as suppliers entitled to a part 498 hearing.
Response: We disagree that the Secretary's inclusion of OPOs in the
part 498 hearings process was required under the statute. Section
1866(h) of the Social Security Act provides for a hearing and for
judicial review of the hearing only for providers; it is silent
regarding appeal rights for suppliers and practitioners. See 42 CFR
498.1(g) (2004).
Further, the OPO Certification Act did not mandate that OPO appeals
be heard by an administrative law judge or expressly require the use of
the part 498 process. The statute mandated only that an OPO must be
able to appeal on substantive and procedural grounds. Thus, under this
final rule, a CMS hearing officer will hear OPO appeals. We have based
the appeals process in this final rule on the appeals processes we use
for appeals of contract terminations under the Medicare Advantage
Program and for Medicaid State Plan Amendment hearings. The appeals
process in this final rule is consistent with the requirements of the
OPO Certification Act.
Comment: Commenters said that eliminating part 498 is inconsistent
with the MMA, which requires ``suppliers'' to be afforded a hearing
identical or comparable to what the Secretary provides under part 498.
Section 901 of the MMA defines a ``supplier'' as ``unless the context
otherwise requires, a physician or other practitioner, a facility, or
other entity (other than a provider of services) that furnishes items
or services under this subchapter.'' Commenters said that in the
preamble to the proposed rule, we concluded that the definition does
not include OPOs, even though CMS has regarded OPOs as suppliers for
the past 17 years.
Commenters said that the MMA definition is an ``expansive''
definition, meant to capture as many types of entities or persons as
possible and that the definition basically provides that anyone or any
entity that provides services pursuant to or under the Medicare program
and that is paid under the program is a supplier (as long as it is not
a provider). Commenters stated that they do not believe there is any
statutory support to demonstrate that the Congress meant for an OPO to
have fewer or different rights than it gives to other types of
suppliers.
Commenters said that they do not think the Congress would support
CMS's narrow interpretation of the term ``supplier,'' since it granted
OPOs an express right to appeal de-certifications on procedural and
substantive grounds in the OPO Certification Act. They pointed out that
at least three Civil Remedies Division cases specifically recognized
the supplier status of OPOs, and two district court decisions did not
set aside that status. They stated that the Congress clearly was aware
of the
[[Page 30992]]
Secretary's conclusion that OPOs were suppliers and clearly relied on
that designation when it enacted the 2000 amendments and that there is
no evidence that the Congress, in passing the MMA, meant to undo the
administrative hearing rights when it enacted the 2000 amendments.
Response: As commenters noted, we proposed removing OPOs from the
definition of ``suppliers'' under the part 498 appeals process. In the
preamble to the proposed rule, we said that the unique nature of OPOs
and their special role in the Medicare program distinguishes them from
other suppliers. (70 FR 6093) We noted that suppliers typically furnish
medical items and services directly to Medicare beneficiaries and
receive a direct payment for those services. We observed that many, if
not most, organ donors are not Medicare beneficiaries, and many organs
recovered by OPOs are not transplanted into Medicare beneficiaries. The
services an OPO furnishes to obtain organs are not designed to diagnose
or treat an illness or injury for the patient from whom the organs are
recovered. Instead, the services are designed to benefit the recipient
of the organs. We also said that OPOs have payment rules and
methodologies that differ from the payment rules and methodologies used
for other suppliers. The legal relationship between an OPO and the
Medicare program is different from that of other suppliers and reflects
important statutory differences. Within this specific context, we do
not believe section 901 requires OPOs to be considered suppliers. This
is particularly the case because the Congress enacted a specific
statutory provision governing OPO appeal rights in 2000, before
enacting the general provision relating to the definition of
``suppliers'' or gave other suppliers additional appeal rights.
We believe that an alternative appeals process will help to
eliminate the uncertainty that the Congress found when it enacted the
OPO Certification Act in 2000. In the Congressional findings
accompanying the 2000 legislation, the Congress expressly found that
the existing recertification process ``created a level of uncertainty''
that was interfering with OPOs ability to raise the level of organ
donation. At least part of the uncertainty was due to the simultaneous
administrative appeals process and the competition process that existed
under the earlier regulations. Under the old process, CMS published a
notice in local newspapers to solicit a new OPO to fill the incumbent's
service area before the appeals process was completed. In the 2000
recertification cycle, three of the OPOs that were slated for
decertification immediately sought and were granted temporary
restraining orders by Federal district courts to bar CMS from
completing the competition process before the appeals process was
completed. Arkansas Regional Ogan Procurement Agency, Inc. v. Shalala,
104 F. Supp. 2d 1084 (E. D. Ark. 2000); Nater-Lebron v. Shalala, 120 F.
Supp. 2d 175 (D. P.R. 2000) (rejecting challenge). While the enactment
of the 2000 legislation ended those controversies, the Congressional
findings suggest that a more streamlined, sequential process would help
to reduce the uncertainty in the recertification process.
In the proposed rule, CMS explained that it was acting to reduce
the level of uncertainty by allowing the OPO to appeal and receive a
decision on the appeal before its service area would be opened for
competition. (70 FR 6087). We will continue this approach in this final
rule. Because of the time constraints between the end of the
certification period and the beginning of the next contract cycle, we
will use a hearing officer to ensure that a decertified OPO will
receive a fair administrative process, and yet one that can be
completed before the competition for a successor OPO (if needed)
begins. The Supreme Court has previously recognized that the use of
unbiased hearing officer can be used in an administrative process in a
manner that is consistent with due process. Schweiker v. McClure, 456
U.S. 188 (1982).
Comment: Commenters said that there is no basis in the record for a
conclusion that the current process is problematic. They noted that the
preamble to the proposed rule explains that the part 498 process has
proven inadequate because the appeals could not be completed before the
OPO contract terminated, thus creating a situation in which competition
by other OPOs would begin before the final decision on de-certification
is complete. Commenters also stated that the preamble to the proposed
rule indicated that the 2-year re-certification cycle was a factor that
complicated the part 498 appeals process. They said that it would be
incorrect, therefore, to conclude that the delays in the appeals
process are attributable solely, or even in major part, to part 498.
Response: We disagree with the commenter who suggested that the
change from a 2-year agreement cycle to a 4-year cycle will
automatically ensure that the appeals process is resolved in a timely
manner. The Congress has specified that multiple outcome measures must
be used in the re-certification process. The data to support the
outcome measures must be collected and analyzed before OPOs can be
given a notice of de-certification that begins an appeals process. The
limited time period between the end of the certification period and the
beginning of the next agreement cycle exists whether the re-
certification cycle is 2 years or 4 years.
Our experience demonstrates that appeals under the part 498 process
take more than 7 months to resolve. For example, we notified an OPO
located in Los Angeles, California, on July 23, 1998 that it would not
be re-designated for its service area. On August 7, 1998, the OPO
requested reconsideration and a hearing before an administrative law
judge (ALJ). Upon reconsideration, we reaffirmed our decision. The OPO
appealed to an ALJ, and we requested that the hearing be expedited, but
the hearing was held on October 6 and 7, 1998. The ALJ's decision to
uphold the de-certification was issued more than 7 months later on May
12, 1999. Thus, even with the expedited time frame for the hearing,
more than 9 months elapsed between the OPO's request for
reconsideration and a hearing and the final decision.
The Congress enacted legislation in 2000, in the aftermath of the
OPO certification cycle that ended on December 31, 1999. At this time,
numerous administrative and judicial proceedings were initiated or in
process as a result of the application of the previous OPO performance
measures. Early in 2000, CMS found that several OPOs had not satisfied
the previous OPO performance measures and were more than 25 percent
below the mean in comparison to other OPOs. After the notice of the
administrative appeal rights were given to each OPO, CMS immediately
initiated the actions required by the regulations then in effect to
compete the OPO's service area and to choose a successor. Several of
the OPOs initiated lawsuits at that time to challenge the basis of the
performance standards and to stop CMS from choosing a successor while
the administrative appeal process was still pending. There were several
injunctions issued. Ultimately, one district court found that the
performance standards were not valid and the government appealed this
decision to the United States Court of Appeals for the Eighth Circuit.
Arkansas Regional Organ Procurement Agency, Inc. v. Shalala, 104 F.
Supp. 2d 1084 (E. D. Ark. 2000). On the other hand, a second district
[[Page 30993]]
court rejected a challenge that asserted that the performance
regulations were arbitrary and capricious. Nater-Lebron v. Shalala, 120
F. Supp. 2d 175 (D.P.R. 2000). The enactment of the 2000 legislation
ended those controversies.
It is within this setting that the Congress found that the process
for the certification and re-certification of OPOs conducted by the
Department in 2000 created a level of uncertainty that interferes with
the effectiveness of organ procurement organizations in raising the
level of organ donation. We proposed numerous changes to reduce the
level of uncertainty by streamlining the process and altering the
timing of the appeals process to facilitate appeals on substantive and
procedural grounds. One of those changes, designed to expedite the
resolution of any administrative appeals in a full, fair, and timely
manner was to move the appeals process from part 498 and assign these
cases to a CMS hearing officer for resolution before we initiate any
competition for an open area.
We are gaining an additional 6 months for the appeals and
competition processes under this final rule by beginning the process
earlier, allowing a total of 13 months from 7 months prior to the end
of the re-certification cycle until the expiration of agreements
between CMS and the OPOs 6 months later. However, even this more
generous time frame would not be sufficient for analysis of data on the
front end, a 9-month appeal process, a competition process, and
transition of an OPO's service area to another OPO.
Opposition to the Proposed Appeals Process
Comment: Commenters said that the proposed appeals process is
constitutionally defective. They said that the proposed appeals process
raises two constitutional concerns both grounded in the due process
protections of the Fifth Amendment to the United States Constitution.
The first is a concern over whether the proposed process is
constitutionally adequate. Commenters stated that prior decisions
indicate that due process generally requires consideration of three
distinct factors: the private interest that will be affected by the
official action; the risk of an erroneous deprivation of such interest
through the procedures used; and the government's interest, including
the function involved and the fiscal and administrative burdens that
the additional or substitute procedural requirement would entail.
Commenters noted that a de-certified OPO must go out of business, and
they pointed out that few property interests under any HHS-administered
programs reach this level of significance and those that do, have part
498 protections.
Response: We believe that the commenter has an inflated view of the
private interests at issue when a party has signed a time-limited
agreement to perform services on the government's behalf. These
interests clearly do not rise to the same level as the welfare
recipient presented to the Supreme Court in Goldberg v. Kelly, 397 U.S.
254 (1969). (``For qualified recipients, welfare provides the means to
obtain essential food, clothing, housing, and medical care.'') These
regulations are fully consistent with the statute and with any due
process rights that an OPO has with respect to its time-limited
agreement with CMS.
Comment: Commenters also said that the proposed process is likely
to cause an unconstitutional commingling of prosecutorial and
adjudication functions. They noted that under proposed Sec.
486.312(c), CMS may issue a notice based solely on failure to meet the
outcome measures set forth in proposed Sec. 486.318. However, the
preamble to the proposed regulations states that the CMS hearing
officer would consider additional evidence not considered by the
primary CMS decision maker, including substantive and procedural
evidence. Commenters stated that the CMS hearing officer would be
considering this information on behalf of the agency for the first
time. Therefore, the CMS hearing officer would not be reviewing the
agency's initial determination; he/she would be making it.
Response: At the conclusion of the re-certification cycle, we will
evaluate an OPO's performance based on its performance on the outcome
and process performance measures and other regulatory requirements. If
we make a decision to de-certify the OPO, the hearing officer will hear
arguments on both substantive and procedural grounds under the OPO
Certification Act legislation. The hearing officer is an impartial
adjudicator, who will assess the reasonableness of the OPO's argument
and make a decision based on the evidence in the record. In our view,
this process is fully consistent with due process, and there is no
commingling of a prosecutorial function.
Recommendations for Revising Proposed Appeals Process
Comment: Many commenters said that they do not oppose modifications
to the part 498 process as long as: (1) The replacement process
provides the same caliber of hearing process and the same protections
as part 498, and (2) permits sufficient time for a complete and
meaningful hearing. However, commenters said that the proposed process
would not meet these criteria.
Commenters said that the proposed rule would eliminate rights that
OPOs now have under part 498, such as the right to reconsideration
before pursuing a formal appeal. Commenters also criticized the
proposed process because the burden of meeting the shortened time frame
would fall entirely on the OPOs. That is, they noted that while we
would require OPOs to meet specific time frames, the appeals process
would not include a time frame for the hearing officer to render a
decision on the appeal.
Commenters further criticized the proposed process because it does
not define the hearing officer's powers. For example, commenters said
that an ALJ has the power to compel discovery of documents and
individuals but there are no written legally enforceable mechanisms
available to the hearing officer.
Commenters also said that we provided insufficient detail for them
to understand how the proposed appeals process would work.
These commenters recommended that we use a CMS hearing officer and
retain the procedures used under part 498 with some modifications to
expedite appeals. They said that their proposal would satisfy the twin
objectives of avoiding an unnecessarily prolonged administrative
process but preserving the important protections in existing part 498.
The commenters provided specific regulatory text language for our
consideration.
Response: After carefully considering the comments, we have made
changes to the proposed appeals process to address some of the
commenters' concerns. While we do not believe it would be appropriate
to retain the part 498 process because of the potential for undue delay
in resolving OPO appeals, we are finalizing an appeals process that
incorporates many recommendations made by commenters. We have based the
appeals process in this final rule on appeals procedures we use in
other settings, including appeals by managed care organizations of
contract terminations under the Medicare Advantage Program. These
appeals procedures have expedited time frames because of the limited
time before competition begins and new agreements must be signed. We
have included additional rights and procedures that provide an
opportunity for an OPO to obtain a fair and expeditious hearing and a
decision on its appeal before the competition process begins. Although
[[Page 30994]]
we did not incorporate every procedure from part 498 or every
recommendation suggested by the commenters for the appeals process, the
new process will ensure that OPOs will have the opportunity to have
their appeals heard in a timely and meaningful manner. An OPO will be
able to appeal a de-certification on substantive and procedural grounds
as the statute requires.
The appeals process in this final rule at Sec. 486.314(g) contains
specific rights for both an OPO appealing a de-certification and CMS.
The parties may: (1) Appear by counsel or other authorized
representative in all hearing proceedings; (2) participate in any pre-
hearing conference held by the hearing officer; (3) agree to
stipulations as to facts which will be made a part of the record; (4)
make opening statements at the hearing; (5) present relevant evidence
on the issues at the hearing: (6) present witnesses who then must be
available for cross-examination; and
(7) present oral arguments at the hearing. Additionally, CMS or its
representative and the OPO or its representative may cross-examine the
witnesses.
In addition, the final rule specifies that the notice of de-
certification must contain the reasons for the de-certification. If a
request for reconsideration is made, we will provide the administrative
record that includes the evidence used in making the de-certification
decision. The administrative record, may include, for example. The
record does not include material that is privileged. While several
commenters have requested that the final rule include provisions
related to discovery, we have determined that discovery is
inappropriate in this context. Instead, we will produce the
administrative record on which we based our de-certification decision.
The hearing officer's authority in conducting the hearing is
specified in this final rule. The hearing officer inquires fully into
all the matters at issue and receives in evidence the testimony of
witnesses and any documents that are relevant and material; provides
the parties with an opportunity to enter any objection to the inclusion
of any document, considers the objection and rules on the document's
admissibility; decides the order in which the evidence and the
arguments of the parties are presented and the conduct of the hearing;
rules on the admissibility of evidence and may admit evidence that
would be inadmissible under rules applicable to court procedures; rules
on motions and other procedural items; regulates the course of the
hearing and conduct of counsel; examines witnesses; receives, rules on,
or excludes or admits evidence; sets the time for filing motions,
petitions, briefs, or other items; and takes any action authorized by
the rules in this subpart. Additionally, the final rule specifies that
the hearing officer must render a decision on the notice of
decertification within 10 business days of the hearing.
At the commenters' request, we have included an opportunity for an
OPO to request a reconsideration as a mandatory step in the appeals
process before the OPO may seek a hearing before the hearing officer.
Under this final rule, an OPO has 15 business days from the date it
receives the notice of de-certification to file a request for re-
consideration. The notice of de-certification will contain instructions
on how to file the request for reconsideration, including where to send
the request. If an OPO does not request reconsideration or its request
is not received timely, the OPO has no further administrative review
rights. We agree with commenters who said that reconsideration can
benefit both CMS and the appellant OPO. Under the reconsideration
process established under this final rule, an OPO may submit additional
information and arguments as to why it should not be de-certified.
The CMS Regional Administrator in the Region in which the OPO's
main office is located will make the reconsideration decision. Regional
Offices are knowledgeable about the OPOs in their regions, as well as
the conditions and factors in a particular service area. The
reconsideration process will allow the Regional Administrator to
consider any procedural or substantive arguments that the OPO would
like to raise to demonstrate that it should not have been de-certified.
If the Regional Administrator determines that the OPO should not be de-
certified, the OPO will be re-certified. If the Regional Administrator
determines that the OPO should be de-certified, he or she will update
the administrative record (which contains a copy of the de-
certification notice, any documents concerning the OPO's performance
during the relevant re-certification cycle, all documents submitted by
both sides to the Regional Administrator during the reconsideration
process, and the Regional Administrator's reconsidered decision) and
forward the record to the CMS hearing officer.
The OPO may file a request for a hearing. The OPO has 40 business
days to file its request. If the OPO does not file a request for a
hearing or its request is not received timely, the OPO has no further
administrative review rights.
We believe the appeals process in this final rule will protect a
de-certified OPO's rights, provide it with sufficient time to pursue
its appeal, and ensure that it receives a fair hearing. Our responses
to the following comments provide additional details about the appeals
process in this final rule.
Details of the Appeals Process
Comment: Some commenters suggested that CMS should start the de-
certification analysis prior to the ending date of the re-certification
cycle. They said that CMS could base the certification data on 48
months of data, but the first 6 months of data could be derived from
the prior re-certification cycle. Commenters pointed out that their
recommended time frames would provide an additional 6 months to
complete the process, which they said would be preferable to a
truncated appeals process.
Response: We agree with the commenters that beginning our analysis
of OPO performance sooner makes sense in view of the time needed for
the appeals and competition processes. Providing additional time for
these processes also helps to avoid the uncertainty identified by the
Congress in 2000. However, we disagree that we should accomplish this
by using data from a prior re-certification cycle. Using 6 months of
data from a prior re-certification cycle would create a comparison
problem when we evaluate the performance of an OPO that takes over
another OPO's service area at the beginning of a re-certification cycle
because we could not use the de-certified OPO's data from the previous
re-certification cycle to evaluate the incoming OPO. Because the
outcome measures evaluate OPOs in comparison to one another, we believe
it is better to use the same amount of data from the same time period
for evaluation of all OPOs. Thus, we will not use data from the
previous re-certification cycle to re-certify OPOs. Instead, we will
use a lesser amount (36 months) of data so that we will ensure that
there is enough time to complete the appeals and certification
processes. Further discussion of the time frames for the data and the
outcome measures is found in this preamble in ``Section 486.318,
Outcome Measures.''
The first re-certification cycle under this final rule will be
August 1, 2006 through July 31, 2010. Thus, we will request data from
the beginning of the 6th month of the re-certification cycle,
[[Page 30995]]
January 1, 2007 through the end of the 41st month, December 31, 2009.
We expect that it will take about 2 months (until February 28, 2010)
for OPOs and transplant hospitals to update their data and for the SRTR
to compile the data to provide an OPO-to-OPO comparison. We expect to
receive the data from the SRTR in early March and notify OPOs by March
15 if an OPO will be de-certified. We have retained a 6-month lag
between the end of the re-certification cycle and the end of the
agreement between OPOs, which means we will have a total of 13 months
from the beginning of the process until agreements between CMS and the
OPOs expire. Note that under this final rule, agreements will expire on
January 31, 2011.
OPOs that have met all 3 outcome measures will be notified about
their re-certification on a flow basis after they have been shown by
survey to be in compliance with all other conditions for coverage. At
this time, we will also notify OPOs that did not meet the outcome
measures or other requirements that the OPO will be de-certified. Once
we notify OPOs of their status, we will have more than 10 months (until
agreements expire on January 31, 2011) for the appeals and competition
processes. This will provide 5 to 6 months for the appeals process,
about 2 months for the competition process, and the remaining months
for transition of service areas to new OPOs, if necessary.
Comment: Commenters suggested that CMS provide some type of pre-
termination notice and suggested that the need for an appeal might be
avoided if CMS provided some type of preliminary or provisional notice
of an imminent or likely non-renewal and permitted the OPO the
opportunity to provide additional, responsive material prior to a de-
certification notice.
Response: As stated earlier in this preamble under ``De-
Certification (proposed Sec. 486.312),'' an OPO will be provided with
a 90-day notice prior to termination, except in cases of urgent need.
When a termination notice is given during the re-certification cycle
because the OPO is substantially out of compliance with a process
performance measure, the OPO is given an opportunity to come back into
compliance prior to termination.
If an OPO has not met all 3 of the outcome measures at the end of
the re-certification cycle, the OPO will receive a de-certification
notice that includes the reasons for the de-certification. A
reconsideration process is included within the appeals process we are
finalizing, which will give an OPO that receives a de-certification
notice the opportunity to provide additional material for
consideration.
Comment: Commenters recommended that one outcome of the appeals
process should be re-certification subject to successfully achieving a
corrective action plan or restoration of status subject to successfully
achieving a corrective action plan.
Response: In general, we do not agree that re-certifying an OPO
based on its achievement of a corrective action plan or restoring its
status based on its achievement of a corrective action plan is an
appropriate outcome of the appeals process. If the OPO has been de-
certified based on non-compliance with the requirements for
certification at Sec. 486.303 but that decision is reversed on
reconsideration or on appeal, the OPO is able to continue to perform
under the terms of the agreement without a corrective action plan. If
the OPO has been de-certified based on failure to meet the outcome
measures or requirements for certification at Sec. 486.303 at the end
of the re-certification cycle, but that decision is reversed on
reconsideration or on appeal, the OPO will be re-certified without a
corrective action plan.
If we find during the term of the re-certification cycle that an
OPO is substantially out of compliance with one or more of the process
performance requirements, we will not necessarily immediately take
steps to de-certify the OPO. Instead, we may exercise our enforcement
discretion to provide the OPO with the opportunity to develop and
implement a plan of correction to come back into compliance. If the OPO
does not come back into compliance, we will issue a notice of de-
certification to the OPO.
We are not willing to exercise our enforcement discretion at the
end of a 4-year cycle. If an OPO has not been able to improve its
performance over the course of the 4-year re-certification cycle, we
believe it is unlikely that an additional attempt at improvement
through a corrective action plan would prove successful. The 4-year re-
certification cycle provides OPOs with more than enough opportunity to
improve their performance on the outcome measures prior to the end of
the re-certification cycle. OPOs should use data derived from their
QAPI programs to monitor and improve their performance continuously.
OPOs can track their performance in comparison to other OPOs by
accessing data on the SRTR Web site at http://www.ustransplant.org.
Comment: Commenters said that according to the preamble of the
proposed rule, the timing of de-certification is an issue only if de-
certification occurs at the end of the term of the OPO's agreement with
CMS. Therefore, commenters said that a de-certification proceeding that
began during the term of the agreement with the intention of making the
de-certification effective prior to the end of the term, would not have
the same timing issues. Commenters concluded that there would not be
any reason for eliminating the part 498 process for involuntary de-
certifications taking place during the term of the agreement.
Response: We do not agree that OPOs should use the part 498 process
to appeal a de-certification that takes place during the re-
certification cycle. We believe it would be more efficient if both
types of OPO appeals used the same administrative appeals process. If
an OPO is not performing well, a decision on the OPO's de-certification
should be made expeditiously so that, if necessary, we can replace the
OPO with an OPO that will increase organ donation in the service area.
Comment: Commenters said they were pleased that CMS recognized both
the need to preserve an OPO's business by delaying the competition
process until after a final de-certification decision is made by a CMS
hearing officer, as well as the need to ensure that the area served is
not left without an OPO, so that organ donation and transplantation
continues without interruption. However, commenters suggested that
there are other means to address these concerns and yet provide a fair
appeals process for OPOs that is consistent with the statute.
Response: We agree with the commenters that CMS must ensure that an
OPO facing de-certification is given adequate appeal rights to resolve
disputes and that those appeals will permit challenges based on
substantive and procedural grounds. Nevertheless, the public has an
interest in increasing organ donation, and the appeals and competition
processes are designed to replace an OPO that is not performing well
with an OPO that is likely to produce better results. If an OPO is de-
certified, the appeals process in this final rule protects the OPO's
rights under the statute and ensures that it does not face competition
from a potential successor until after the administrative appeal has
concluded. We believe that the process established in this final rule
is fair and consistent with the statute and the public's interest.
Comment: Commenters said that the final rule should explicitly
provide that the CMS agreement and payment for
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services will continue during an appeal of a termination or non-
renewal. They said that under the proposed regulations, the possibility
exists that an OPO may not be paid while an appeal is pending because
there are no time limits provided for the length of time that a CMS
hearing officer may take to decide an appeal and because the entire
notification process might ``slip'' or run behind schedule. Commenters
also said that by terminating the agreement on July 31, and allowing
only a discretionary extension, the proposal fails to protect an OPO's
constitutionally protected property interest adequately.
Response: Using 36 months of data will start the process sooner.
Thus, we believe it is unlikely that we will need to extend the
agreements. With respect to an OPO that was de-certified for failure to
meet the outcome measures and where the de-certification was upheld in
the appeals process, the OPO can be paid until the end of the agreement
with CMS. The appeals process we are establishing under this final rule
places no time limitation on the extension of the agreement between CMS
and the appellant OPO if needed in some cases to complete the appeals
and competition processes. If the OPO appeals and loses the appeal, we
would pay the OPO during and after the competition process until a
successor OPO has taken over the service area to ensure that there is
no disruption in organ procurement activities.
Comment: Commenters questioned proposed Sec. 486.314(b) which
states that if the OPO wins on appeal, CMS will not de-certify the OPO
``at that time.'' Commenters asked whether ``at that time'' means the
time the hearing officer's decision is announced or whether it is
retroactive to the date CMS imposed the involuntary termination.
Response: The language in question, ``CMS will not terminate the
OPO's agreement and will not de-certify the OPO at that time'' meant
that by not de-certifying the OPO following its successful appeal, CMS
was not waiving the right to de-certify the OPO at some time in the
future if it were found to be out of compliance with one or more of the
outcome and process performance measures. If the reconsideration
official or hearing officer overturns the OPO's de-certification, CMS
will re-certify the OPO.
Re-Certification and Competition Processes (Proposed Sec. 486.316)
In our February 4, 2005 proposed rule, we proposed opening every
OPO's service area for competition at the end of every re-certification
cycle, as in the existing regulations. However, we proposed certain
limitations that we said would address the uncertainty in the re-
certification process that the Congress noted. We said that the
proposed limitations would ensure that: (1) The process can be
completed expeditiously; (2) disruptions to service areas will be
minimized; and (3) an OPO may compete for an open area only if it is
likely to be able to improve organ donation in the service area.
We proposed that once we determined that an OPO met the outcome
measures at proposed Sec. 486.318 for the previous re-certification
cycle and was found to be in compliance with the process performance
measures at Sec. Sec. 486.320 through 486.348, we would open the OPO's
service area for competition from other OPOs. Under the proposed rule,
to compete for open areas, OPOs would be required to meet certain
criteria based on data from the preceding re-certification cycle. An
OPO would be required to meet the following: (1) 4 out of 5 outcome
performance measures at or above the mean; and (2) a conversion rate of
potential donors to actual donors at least 15 percentage points higher
than the conversion rate of the OPO currently designated for the
service area. OPOs would be required to compete for an entire service
area. The incumbent OPO would be permitted to compete for its own
service area.
We proposed that in selecting an OPO for the service area, we would
consider each OPO's success in meeting the process performance measures
during the prior re-certification cycle, as well as submission of an
acceptable plan to increase organ donation in the open service area.
We proposed that an acceptable plan would, at a minimum: (1) Be
based on the competing OPO's experience in its own service area; (2)
include an analysis of existing barriers to increasing organ donation
in the open area, both internal (for example, high staff turnover) and
external (for example, language barriers due to a high number of recent
immigrants in the OPO's service area); and (3) provide a detailed
description of specific activities and interventions for increasing
organ donation in the open area. An OPO's plan to increase organ
donation in the open service area would be used by us to assist in
identifying the most effective organization to maximize organ donation
in the open area.
We received more comments on our proposed requirements for the re-
certification and competition processes than on any other section in
the proposed rule. All comments on the proposal were negative, and all
commenters who expressed a preference for one of the alternatives we
described in the preamble to the proposed rule chose the highly
restricted competition process in which only service areas of de-
certified OPOs would be opened for competition. In this final rule, we
are making changes to the competition process consistent with the
public comments, which we discuss in detail below.
Comment: Commenters, including state hospital associations and many
large hospitals that have participated in the Department's Organ
Donation Breakthrough Collaborative, strongly objected to our proposed
competition process, stating that it would have a negative affect on
the Collaborative. Commenters noted that the foundation for the success
of the Collaborative--cooperation, collaboration, and the sharing of
best practices and change strategies--would be threatened by the
proposed competition process.
Many commenters said that the nearly 11 percent increase in organ
donation from 2003 to 2004 can be directly attributed to the
Collaborative. Numerous commenters, including hospitals that
participated in the Collaborative, said that the Collaborative has had
a significant impact on their own donation rates. A 600-bed hospital
said that its donation rate increased from 47 percent prior to the
Collaborative to 75 percent. A transplant hospital said that it was
able to start a liver transplant program because the number of livers
recovered locally increased so much under the Collaborative.
Commenters voiced concern that open competition would promote a
return to proprietary information and limited data transfers between
OPOs rather than advancing the sharing of ``best practices'' and change
strategies. All who commented on our competition proposal said the
competition process we proposed would seriously undermine the prospects
for sustaining the recent outcomes attributable to the Collaborative.
Response: We acknowledge that the Collaborative has been, and
continues to be, an extraordinary success, and we are pleased that OPOs
and hospitals continue to participate. Clearly, much of the
Collaborative's success has resulted from the willingness of OPOs to
share data and information on what works best to increase organ
donation. We understand the commenters' concern regarding the potential
impact of competition on the collaboration and partnerships that are
the hallmark of the Collaborative, and we do not wish to finalize a
competition process that will
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unnecessarily interfere with the free flow of data and other
information among OPOs.
We have reassessed our proposed competition model in view of the
comments, and we agree that open competition has the potential to
threaten the widespread collaboration and sharing of best practices
that has led to such large gains in organ donation and transplantation.
We have concluded that it would be inadvisable to finalize a process
that opens every OPO's service area to competition at the end of every
re-certification cycle. Therefore, we are finalizing this rule with a
competition process that applies only to the service areas of OPOs that
have been de-certified. Thus, most OPOs, as they monitor their
performance throughout the re-certification cycle, can be confident
that we will not open their service areas for competition from other
OPOs.
Instead of all OPO service areas being opened for competition at
the end of every re-certification cycle, an OPO that meets the
following criteria at Sec. 486.316(a) will be re-certified for an
additional 4 years, and its service area will not be opened for
competition: (1) Meets all 3 of the outcome measure requirements at
486.318; and (2) has been shown by survey to be in compliance with the
requirements for certification at Sec. 486.303. We have revised Sec.
486.316 accordingly.
Comment: Some commenters referred to the congressional findings
associated with the OPO Certification Act, stating that the Congress
found that the process for OPO re-certification created a level of
uncertainty among OPOs that interfered with their effectiveness in
increasing organ donation. These commenters said that the proposed
competitive framework is antithetical to the findings of the Congress
that the prior process was disruptive and that the Secretary needed to
undertake regulatory reform.
Response: We believe that replacing the open competition model in
the existing regulations with a competition process that applies only
to the service areas of de-certified OPOs, as well as permitting OPOs
to compete only for entire service areas, will reduce or eliminate any
uncertainty associated with the re-certification of OPOs.
Comment: Many commenters noted that under the proposed framework,
an OPO would risk losing its service area, regardless of its success in
meeting the outcome and process performance measures. Commenters said
that the proposed process would degrade the point of having performance
measures.
Response: We agree with the commenters that an OPO's relative
success in meeting the outcome and process performance measures should
be the deciding factor when we open an OPO's service area to
competition. As stated in our previous responses, under this final rule
we will open only the service areas of de-certified OPOs to
competition.
Comment: Commenters agreed with us that the criteria OPOs must meet
to compete for an open area should recognize higher performance. One
commenter provided recommendations for defining a high performing OPO,
specifying that the competing OPO should be required to have an
adjusted 4-year conversion rate of 110 percent of the mean or an SRTR-
based donation rate (hospital characteristics, notification rate)
statistically higher than expected for 3 of the 4 years of the
performance cycle.
Response: We appreciate the commenter's specific recommendations.
We agree that we must ensure that an OPO permitted to compete for
another OPO's service area both performs well in its own service area
and demonstrates a performance that is significantly better than the
performance of the de-certified OPO. To compete for an open service
area, an OPO's performance on the donation rate outcome measure and
yield outcome measure must be at or above 100 percent of the mean
national rate averaged over the 3 years during the re-certification
cycle. In addition, the OPO's donation rate must be at least 15
percentage points higher than the donation rate of the OPO currently
designated for the service area. The criteria we have included in this
final rule fulfill both of those objectives, and we do not believe it
is necessary to add complexity to the process by including another
criterion.
Comment: Commenters said they agreed that when an OPO is de-
certified, we should not permit the OPO to compete for its own service
area. Commenters also endorsed our proposal to permit OPOs to compete
for entire service areas.
Response: We appreciate the commenters' support. We believe one of
the most important changes we are making to improve the current
competition process is to preclude OPOs from competing for partial
service areas. As we stated in the proposed rule, we found that
permitting competition for partial service areas provided an incentive
for OPOs to attempt to take over portions of neighboring service areas
for purely business reasons, with no regard to whether they could
increase organ donation in those areas. We believe that limiting OPOs
to competition for whole service areas will cause them to think
carefully about the advantages and disadvantages of operating
throughout the service area and will discourage OPOs from competing
merely to gain access to a portion of the area that has a high donor
potential.
Comment: Several commenters said that we should not implement an
OPO competition decision until the competing OPO(s) are able to verify
independently the outcome measures on which the competition is based.
This analytic audit should include, but not be limited to, empirically
obtained information, such as, death record reviews and analysis of
data associated with hospital donor potential in each service area.
Commenters added that an independent entity should conduct an onsite
audit.
Response: We understand the concern that prompted these comments.
OPOs want to be certain that the data used as the basis for competition
decisions (as well as re-certification and de-certification decisions)
are completely accurate. We share the commenters' desire for accuracy,
and we believe the checks and balances used throughout the performance
cycle to verify the OPO's self-reported data will guarantee to the
extent possible, the accuracy of the data. For example, as discussed in
this preamble under ``486.318, Outcome Measures,'' the SRTR-based
donation rate, because it is based on data from the National Center for
Health Statistics, will act as an independent validation of the OPO
self-reported donation rate data. If the SRTR-based donation rate data
cast doubt on the accuracy of an OPO's self-reported data at any point
during the re-certification cycle, CMS may conduct a complaint
investigation to determine whether the OPO is out of compliance with
the requirements at Sec. 486.328.
Additionally, we expect that OPOs will monitor their data reporting
throughout the performance cycle to confirm that they are reporting
data accurately to the OPTN and the SRTR and that the data published by
the OPTN and the SRTR are accurate. The average OPO recovers about 120
donors per year; it should not be difficult or burdensome for each OPO
to verify independently whether its data are reflected accurately on
the OPTN and SRTR Web sites.
We believe that efforts by CMS and the OPOs to validate the
accuracy of data throughout the re-certification cycle, along with the
ongoing data monitoring of the OPTN and SRTR, will ensure that the data
used for the
[[Page 30998]]
competition process are as accurate as possible, without the need for
audits that must be conducted after the close of the re-certification
cycle, delaying decision making and adding to the uncertainty of the
process. Once we choose an OPO for a donation service area, the OPO
must be able to move into the area quickly, so that disruption of organ
donation is minimized.
Comment: Commenters said that the proposed regulations do not
provide for an appeal by any of the unsuccessful prospective bidders
for the open service area, whereas the existing regulations permit an
unsuccessful bidder to appeal using the procedures set forth in part
498. Commenters suggested that we should finalize regulations that
permit part 498 appeals between or among potential bidders for an open
area.
Commenters further said that the proposed rule did not include an
opportunity for an OPO to inspect or challenge the assertions made by a
competing OPO in its application (for example, through some type of
review and rebuttal procedure). They said that this shortcoming removes
an important safeguard and requires CMS to make decisions based merely
on the assertions of an applicant.
Response: We do not agree that OPOs competing for an open service
area should have the right to appeal if they are unsuccessful
competitors. The statute requires only that we provide the opportunity
to appeal a de-certification. An appeals process following competition
would be both expensive and unwieldy. We believe it would increase
uncertainty for the OPO that prevailed in the competition and that this
may disrupt the new OPO's ability to increase organ donation in the
service area.
An OPO that seeks to compete for an additional service area does
not have an intrinsic right to be awarded the service area. The
competition process is designed to enable CMS to choose the OPO that is
most likely to increase organ donation in the service area and thereby
serve the best interests of organ donation, potential organ donors and
recipients in the service area, and the organ donation and
transplantation system in the United States. Thus, if we make a
decision that an open service area will be taken over by one of a
number of OPOs bidding for the open area, our competition decision is
final. We are rejecting the public comments suggesting that we provide
an additional appeal following competition.
Comment: Many OPOs that commented recommended that when a service
area is open because CMS de-certified the OPO, and no OPO applies for
the entire area, CMS should not force another OPO to take over the
service area but should first permit OPOs to apply for portions of the
open area. Some commenters suggested that if some areas were still open
after allowing competition for partial areas, CMS should use the
opportunity to permit the introduction of entirely new organizations to
qualify as OPOs.
Response: We do not agree with the commenters. If an OPO is de-
certified and the CMS hearing officer upholds the appeal, the best
interests of organ donation in the open area dictate that we should
replace the de-certified OPO as quickly as possible. If no OPO applies
for the open area, there would not be time to sort out the competing
interests of OPOs that seek to take over only a small portion of the
service area. Therefore, we have finalized this provision of the
proposed rule as it was proposed. If no OPO applies to compete for a
de-certified OPO's open area, we may select a single OPO to take over
the entire open area or may adjust the service area boundaries of two
or more contiguous OPOs to incorporate the open area.
Note that we currently do not have the authority to permit new
entities to take over part or all of an OPO's service area, as one
commenter suggested. This would be possible only if the Congress enacts
legislation to change the requirement in the PHS Act because currently
to be re-certified, an OPO must have been certified as of January 1,
2000. (See 42 U.S.C. 273(b)(1)(D).)
Comment: One commenter suggested that we should permit only OPOs
with contiguous service areas to participate in the competition in
order to reduce inefficiencies created by operating multiple service
areas. The commenter also noted that permitting only OPOs with
contiguous service areas to compete would also increase the chance that
competing OPOs would have a greater knowledge of the service area, thus
supporting smoother transitions and a greater likelihood of increasing
the donation rate.
Response: We believe the commenter may have a valid point. An OPO
that is contiguous to an open service area may have more knowledge than
a non-contiguous OPO of the operations of the incumbent OPO, as well as
knowledge of factors in the service area that work both for and against
organ donation. Nevertheless, we would not want to eliminate the
possibility of a non-contiguous OPO that has performed very well on the
outcome measures taking over an open service area. Therefore, rather
than prohibiting competition by non-contiguous OPOs, we will take an
OPO's contiguity to an open area into consideration when selecting an
OPO for the open area. We have added language to the regulatory text at
Sec. 486.316(d) to include contiguity of a competing OPO's service
area to that of the open area as one of the factors we will consider in
selecting the OPO that will be designated for the open area.
Comment: Commenters said that the proposed regulations do not set
forth quantitative criteria for CMS's selection of one OPO over
another. Commenters said that the proposed rule essentially would
eliminate any tangible criteria to compare competing OPOs and grant CMS
officials unlimited discretion to apply the three very vague and
minimal standards. Commenters recommended that CMS insert objective
outcome criteria in place of the less quantifiable performance criteria
when comparing OPO applicants, and they recommended that CMS indicate
in advance the degree of weight that it intends to place on each
decision factor that it uses.
Some commenters suggested that we reinstate the ``tie-breaker''
decision criteria in the existing regulations so that there are more
concrete means to measure the success of the bidding OPOs.
Response: We agree with the commenters' recommendations for more
objective measures, and we have made changes in the selection criteria
based on their comments. However, we do not agree that we should
reinstate the tie-breaker criteria in the existing regulations because
some of the tie-breaker criteria are subjective. For example, one of
the six criteria is an OPO's ``willingness and ability'' to place
organs within the service area.
Therefore, under this final rule, we will base our selection of an
OPO for an open donation service area on the following criteria: (1)
Performance on the outcome measures; (2) relative success in meeting
the process performance measures; (3) success in identifying and
overcoming barriers to donation within its own service area and the
relevance of those barriers to barriers in the open area; and (4)
contiguity to the open donation service area. While these criteria are
more objective than those we proposed, we will have the flexibility to
exercise reasonable judgment in choosing between competing OPOs.
When comparing competing OPOs, we will first consider each OPO's
performance on the outcome measures and the degree to which the top-
performing OPO's performance on the outcome measures exceeds the
performance of other competitors. We
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may judge small variations in performance among competitors to be
relatively unimportant. However, if one OPO performed significantly
better than its competitors on all three outcome measures, we will rank
the OPO very highly.
We will also take into account each competitor's relative success
in meeting the process performance measures. By ``relative success,''
we mean that we will judge whether the OPO simply satisfied the
requirements necessary to meet the process performance measures or
whether the OPO exceeded the requirements. For example, we will
consider whether an OPO used the data from its QAPI program to track a
few functions, such as requesting consent, and instituted minor
adjustments to its operations or whether the OPO tracked every aspect
of its functioning and, where necessary, made systemic changes
throughout the organization to effect improvement.
Further, we will carefully assess each OPO's experience and success
in identifying and surmounting barriers to organ donation in its own
donation service area. An OPO competing for an open service area must
submit information and data that describe the barriers in its service
area, how they affected organ donation, what steps the OPO took to
overcome the barriers (such as hospital development, training, or
public education), and the results.
In addition, we will take into account whether a competitor's
experience is relevant to the specific barriers in the open service
area. Although all OPOs may face obstacles to organ donation in their
donation service areas, the nature of the barriers and the degree to
which they interfere with organ donation vary widely throughout the
country. Thus, for example, an OPO's experience in overcoming
geographic barriers to organ donation in remote areas of the
southwestern United States is not a guarantee that the OPO can
successfully overcome other types of barriers, such as demographic
barriers, that may exist in a large urban area.
Finally, we will take into consideration a competitor's contiguity
to the open area. When we select among competing OPOs, we will weigh
each of the first three criteria equally. We will use contiguity to the
open area as a deciding factor if we determine that two competing OPOs
are equally competent to take over an open area. However, if no OPO
applies for an open service area, and we must select one or more OPOs
to take over a service area, contiguity to the open area will be a
significant consideration.
Comment: We received a comment from a large university hospital
criticizing our proposed competition model because it is ``based on a
premise that does not consider regional variation in donation service
area cultures.'' The hospital said that because an OPO performs well in
its own service area and better than an OPO serving in a different
service area, it does not necessarily follow that the more successful
OPO will be able to improve donation rates in a new service area with a
different culture. The hospital stated, ``* * * there is a risk in
allowing OPOs to assume new service areas under this assumption because
we have learned in the collaborative that relationships with donor
hospitals are key to the successful functioning of OPOs. If an OPO
assumes a new DSA, begins new relationships with every donor hospital,
and is implementing new ways of approaching organ donation, given the
amount of change and lack of established relationships, it is more
likely donation rates could decrease rather than increase.''
Response: We agree with the comments. As stated in our previous
response, we have made changes to the proposed criteria for selecting
an OPO to take over an open area. One of the criteria is the degree of
an OPO's success in identifying and overcoming donation in its own
service area, as well as whether the competitor's experience is
relevant to the barriers that are specific to the open area. We will
encourage competing OPOs to submit information and data to us that
demonstrate their own experience in conquering barriers to organ
donation, as well as a description of the strategies they would use to
overcome barriers in the open area. We will carefully consider the
extent to which an OPO's familiarity with obstacles to organ donation
and its experience in overcoming them would transfer successfully to
the open service area.
Condition: Outcome Measures (Sec. 486.318).
The February 4, 2005 proposed rule set forth five outcome measures
for OPOs not operating exclusively in non-contiguous U.S. States,
territories, possessions, or commonwealths. We proposed that an OPO
would be required to achieve at least 75 percent of the national mean
for 4 of the 5 following outcome measures, averaged over the 4 calendar
years before the year of re-certification: (1) Donors, as a percentage
of the potential donor denominator; (2) number of kidneys procured, as
a percentage of the potential donor denominator; (3) number of kidneys
transplanted, as a percentage of the potential donor denominator; (4)
number of extra-renal organs procured, as a percentage of the potential
donor denominator; and (5) number of extra-renal organs transplanted,
as a percentage of the potential donor denominator. We proposed that an
OPO operating exclusively in non-contiguous U.S. States, territories,
possessions, or commonwealths would be required to meet the following
outcome measures at 50 percent or more of the national mean averaged
over the 4 calendar years before the year of re-certification: (1)
number of kidneys procured, as a percentage of the potential donor
denominator and (2) number of kidneys transplanted, as a percentage of
the potential donor denominator. We have made changes to this proposed
section, which we discuss in detail below.
Comment: Many commenters said that because the five proposed
outcome measures are highly correlated, the proposed outcome measures
do not satisfy the mandate of the Organ Procurement Organization
Certification Act (section 701 of Pub. L. 106-505) (OPO Certification
Act) to ``establish multiple outcome measures.'' A national association
that represents all OPOs stated that its analysis indicates that if an
OPO does not meet the threshold for the overall conversion rate (that
is, the number of organ donors as a percentage of potential donors, the
first of the five measures in the proposed rule), it is highly unlikely
that the OPO will be able to meet the threshold for the four remaining
measures. The association said that ``the correlation between kidneys
recovered per eligible death, kidneys transplanted per eligible death,
extra-renal organs recovered per eligible death, and extra-renal organs
transplanted per eligible death with organ donors per eligible death is
very high and ranges from .81 to .97.'' According to the association,
``Given the high inter-correlation between the five proposed conversion
ratios, little additional information regarding performance is provided
by the inclusion of the proposed four organ-related conversion
ratios.'' Many commenters, including individual OPOs, specifically
endorsed the association's comments.
Response: We agree with the commenters' suggestions that the
proposed outcome measures were highly correlated. The OPO Certification
Act required that the Secretary establish regulations to require, among
other things, the use of ``multiple outcome measures as part of the
certification process.'' Because the proposed
[[Page 31000]]
measures were highly correlated, we agree with the commenters that a
broader set of measures would better satisfy the statutory requirement
for multiple outcome measures. Thus, we are not adopting the proposed
outcome measures contained in Sec. 486.318(a). Instead, in this final
rule, we establish 3 outcome measures for OPOs: (1) Donation rate; (2)
observed donation rate compared to the expected donation rate, as
calculated by the SRTR; and (3) a yield measure for both organs
transplanted per donor and organs used for research per donor.
The first outcome measure will allow us to assess an OPO's
conversion rate of potential donors to actual donors so that we can
determine how an OPO has performed in regard to the donor potential
(that is, the number of eligible deaths) in its own DSA, as well as how
it has performed when compared to other OPOs. This outcome measure--the
donation rate--is nearly identical to the first of our proposed outcome
measures. Our proposed measure assessed the number of actual donors as
a percentage of organ donor potential. DCDs were counted in the
numerator but not the denominator of this proposed measure. However,
commenters believed that including DCDs only in the numerator of the
donation rate outcome measure weighted DCDs too heavily; therefore, in
the donation rate outcome measure in this final rule, we will account
for DCDs and donors over the age of 70 by adding a 1 to both the
numerator and the denominator for each DCD and each donor over the age
of 70. We agree with the commenters that this methodology weights these
donors appropriately in the donation rate ratio.
The second outcome measure uses the statistical methodology
developed by the SRTR for determining an expected donation rate for
each OPO, which will allow us to assess with a reliable degree of
accuracy how an OPO has performed in view of its expected performance.
In the proposed rule we said that the existing methodologies for
estimating donor potential, which are based on regression analysis,
were unreliable and could not be used for OPO certification. However,
the SRTR statistical methodology for determining an OPO's expected
donation rate is more reliable and more precise than these earlier
methodologies. This second outcome measure, which assesses an OPO's
observed donation rate as a percentage of its expected donation rate,
that is, the Standardized Ratio, is an integral piece of our three-part
OPO outcome measures framework. The Standardized Ratio is calculated as
the ratio of the observed donation rate to the expected donation rate
where 1.0 is equal to the reference. A ratio above 1.0 indicates that
the observed donation rate for an OPO is greater than the expected,
while ratios below 1.0 indicate that the observed donation rate is less
than what would be expected given the national experience.
The third outcome measure is comprised of three individual measures
for organs transplanted per donor and organs used for research per
donor. This third measure allows us to assess how well an OPO fulfills
its ultimate mission--recovering viable organs and placing them with
transplant centers for transplantation, as well as its commitment to
placing organs for research.
The OPTN, SRTR, HRSA, and the CMS OPO Coordinators use these
outcome measures in the Collaborative and their other quality
improvement projects with OPOs. We have found that the three measures,
when used together, form a better picture of overall OPO performance
than any of the other measures available today or anticipated in the
near future.
We also believe that the new measures satisfy the OPO Certification
Act's requirement that we use multiple outcome measures as part of the
certification process, and that the outcome measures are based on
empirical evidence, that has been obtained through reasonable efforts
of organ donor potential and other related factors in each OPO's
service area. Each measure is empirical, that is, based upon
observation or statistically derived from data. Most of the data are
already self-reported to the OPTN, so they are obtained through
reasonable efforts. In addition, all three measures are based on organ
donor potential or other related factors in each DSA. These individual
outcome measures will be discussed in detail in our responses to the
public comments recommending the measures.
Comment: We received comments on proposed Sec. 486.314, Appeals
Process, that relate to the time period we proposed using to calculate
the outcome measures. That is, we proposed using 4 years of data from
the most recent 4-year re-certification cycle. However, many commenters
suggested that to extend the time period available for the appeals and
competition processes, we should consider using fewer months of data
from what would be the most current re-certification cycle, along with
6 months of data from the previous re-certification cycle.
Response: We agree with the commenters that it would be sensible to
extend the amount of time available for the appeals and competition
processes by beginning the appeals process prior to the end of the re-
certification cycle, and we have incorporated their recommendation into
this final rule. However, we disagree that it is necessary to utilize
data from a previous re-certification cycle. We believe that using data
from a previous re-certification cycle would be problematic when we
compare the performance of an OPO that takes over another OPO's service
area at the beginning of a re-certification cycle to the performance of
all other OPOs, because data from the previous re-certification cycle
would reflect the performance of the de-certified OPO, not the incoming
OPO. We believe that to be fair, we should use the same amount of data
from the same period of time for evaluation of OPOs. Therefore,
although we will begin the appeals process sooner, we will not include
data from a past re-certification cycle when applying the outcome
measures to evaluate OPO performance.
In addition, we will not use data from the first 5 months of a re-
certification cycle to re-certify OPOs, which means that we will base
the outcome measures on only 36 months of data. For example, when re-
certifying OPOs in 2010, we will use data from January 1, 2007 through
December 31, 2009. This will ensure that all OPOs are evaluated using
the same amount of data from the same period of time. We made this
decision for three reasons. First, in the future, if we use data from
the very beginning of the re-certification cycle and an incoming OPO is
unable to take over its new service area at the beginning of the re-
certification cycle (because the appeals or competition processes take
longer than expected), we would not have the same amount of data for
the incoming OPO that we have for other OPOs. Second, in most cases,
this method of handling data will provide an OPO that takes over a
service area with some time to orient new staff and develop
relationships with the hospitals in its new service area before we
evaluate its performance. Finally, since the SRTR already compares OPOs
based on data from each discrete calendar year, re-certifying OPOs
based on 3 calendar years of data is the most efficient method for re-
certification.
In the rare instance that an OPO takes over another OPO's service
area during the term of the re-certification cycle (on a date later
than January 1 of the first full year of the re-certification cycle),
so that we do not have 36 months of data available to evaluate the
OPO's performance in its new service area, we will not include the
OPO's performance on the outcome measures in the new
[[Page 31001]]
service area until the end of the following re-certification cycle when
a full 36 months of data are available.
Comment: Many commenters said they were pleased that the proposed
outcome measures were based on organ donor potential rather than
population.
Response: We agree that ``organ donor potential'' (termed
``eligible deaths'' in this final rule) is a more precise measure than
population for evaluating an OPO's performance within its DSA. (See
discussion of Sec. 486.302, Definitions, in this preamble.) In 2001,
the OPTN began collecting and the SRTR began analyzing ``eligible
death'' data from each OPO.
Comment: One commenter said that whereas organ donor potential is a
far better denominator than population, there are still significant
differences among populations in different areas of the country. The
commenter stated, as an example, that certain minority groups have
lower rates of consent to organ donation. The commenter recommended
that we develop an ``expected consent rate'' that takes into
consideration the percentage of minorities, new immigrants, and
undocumented immigrants in each OPO's service area and measure the
OPO's consent rate against its expected consent rate.
Response: We are not aware of any currently available measure for
``expected consent rate.'' Therefore, we are not including an expected
consent rate outcome performance measure in this final rule. Although
an OPO cannot change the number of potential organ donors in its DSA,
there are many steps, such as public education and using ``like''
requestors (that is, designated requestors with backgrounds similar to
those of potential donor families) that an OPO can take to raise its
conversion rate.
Comment: A commenter who supports the use of organ donation
potential in the CMS outcome measures said that population demographics
should be considered along with potential. For example, the commenter
pointed out that in some areas, donors are older and that even
``standard criteria'' donors may be sicker than in other parts of the
country.
Response: HRSA has advised us that the OPTN and SRTR are
considering whether certain conditions and circumstances that may
affect the health of standard criteria donors (SCDs) should be factored
into the measures used to evaluate OPO performance. If the OPTN and
SRTR make this change, we will consider whether we should incorporate
it into our outcome measures through future rulemaking. Nevertheless,
we believe the outcome measures in this final rule are sufficiently
comprehensive in their evaluation of OPO performance to ensure their
validity, regardless of whether changes are made in the future to the
definition of ``standard criteria donor.''
Comment: Commenters said that differentiating kidneys from extra-
renal organs in the outcome measures is irrelevant and that we should
include kidneys and extra-renal organs as one measure.
Response: We agree with the commenters that we should no longer
differentiate between kidneys and extra-renal organs under most
circumstances. As discussed below, under the outcome measures adopted
in this final rule, there will no longer be a distinction between
kidneys and extra-renal organs, except for OPOs operating exclusively
in non-contiguous U.S. states, commonwealths, territories, and
possessions. (See Sec. 486.318(b).)
First Outcome Measure: Donation Rate
Comment: Instead of the five proposed conversion ratios, the
national association that represents the OPOs, as well as many other
commenters, recommended that one single conversion or donation rate--
the number of actual donors as a percentage of the potential donor
pool--be utilized, along with other outcome measures.
Response: We have accepted the commenter's recommendations. The
first of the three outcome measures in this final rule is a donation
rate, that is, the number of eligible donors (actual donors who met the
eligibility criteria) as a percentage of the number of eligible deaths.
``Eligible deaths'' constitute the pool of potential donors who meet
the criteria for medical suitability for donation. (See Sec. 486.302
for the specific criteria for an ``eligible death.'')
Comment: Some commenters drew attention to the fact that a donation
rate outcome measure would be based on self-reported hospital referral
data. (In both the proposed rule and in this final rule, the first
outcome measure is a donation rate, that is, the number of actual organ
donors (``eligible donors'' in this final rule) as a percentage of the
number of potential organ donors (``eligible deaths'' in this final
rule). The number of eligible deaths is a subset of the deaths that
hospitals report to their designated OPOs. Hospitals are required to
report all deaths and imminent deaths to OPOs under Sec. 486.345.)
Commenters said that if an OPO does not develop good working
relationships with its hospitals, the hospitals likely will not refer
all deaths or imminent deaths to the OPO or they will not refer them in
a timely fashion. Commenters said that basing an outcome measure on
hospital referrals lets the OPO that has not worked at developing its
relationships with hospitals ``off the hook.'' That is, the number of
eligible deaths would be under reported by the hospital to the OPO and
thus by the OPO to the OPTN, resulting in a ``false high'' donation
rate. Commenters pointed out that the proposed rule did not include a
provision for independent verification of the self-reported data.
Response: We will monitor OPOs closely to ensure that they develop
their relationships with hospitals appropriately, particularly those
hospitals with a large number of potential donors, to ensure that the
OPO receives hospital referrals timely. Further, although the donation
rate outcome measure in this final rule is based on self-reported data,
the SRTR statistical methodology is not. (See Sec. 486.318(a)(2).)
While the number of ``eligible deaths'' is reported by OPOs to the
OPTN, the number of ``notifiable deaths'' (the subset of all in-
hospital deaths age 0-70 with no exclusionary medical diagnoses for
possible donation) is calculated by the SRTR based on data from the
Office of Analysis and Epidemiology, National Center for Health
Statistics, Centers for Disease Control and Prevention. By assessing an
OPO's reported number of eligible deaths in view of its notifiable
deaths, the SRTR can ascertain whether the data reported by an OPO are
likely to be correct. If the data indicate that an OPO may not be
reporting the number of eligible deaths in its service area correctly,
we will treat this information as a complaint and will conduct a
complaint investigation of the OPO. Ultimately, it is each OPO's
responsibility to ensure that the data they submit to the OPTN are
valid.
Comment: Commenters also said that the outcome measures for kidneys
and extra-renal organs procured are subject to manipulation by OPOs
that recover organs that can not be transplanted, simply to increase
their procurement rate.
Response: We consider a ``donor'' to be a deceased individual from
whom at least one vascularized organ is removed for the purpose of
transplantation. Thus, data on the number of donors, as well as the
number of organs recovered, are subject to manipulation by an OPO that
recovers an organ that is not suitable for transplantation, solely for
the purpose of increasing its performance numbers. However, this final
rule includes a measure that can not be manipulated--organs
transplanted per donor. (See
[[Page 31002]]
Sec. 486.318(a)(3).) This outcome measure will provide a true picture
of an OPO's performance in regards to the number of viable organs it
recovers.
Comment: Many commenters recommended that any donation rate outcome
measure should include incentives for maximizing the number of donors,
including DCDs (donors after cardiac death) and ECDs (expanded criteria
donors). Commenters criticized our proposal for including such donors
in the numerator of the donation rate ratio without including them in
the denominator. They said that incorporating DCDs and ECDs in the
numerator alone: (1) Places a disproportionate weight on these donors;
(2) raises the national conversion rate to the detriment of OPOs that
do not recover many DCDs and ECDs (perhaps because they have fewer
potential DCDs and ECDs); and (3) may inadvertently mask opportunities
for improvement in recovery of standard criteria donors. Therefore,
commenters recommended that we exclude these donors from the national
rate but include them in the numerator and denominator of each
individual OPO's donation rate ratio as adjustments to individual OPO
conversion rates.
Response: We agree with the commenters' recommendation, and we are
adopting this change in this final rule. Absent this change, OPOs that
have a low number of potential DCDs and ECDs could be disadvantaged,
even de-certified, if the SRTR were to include these donors in the
numerator of the donation rate ratio when computing the national
donation rate. Therefore, under this final rule, when an OPO recovers
an ``additional donor,'' that is, a deceased donor over the age of 70
or a DCD, a ``1'' will be added to both the numerator and the
denominator of the OPO's donation rate ratio. The SRTR includes data on
additional donors in its organ donation tables at http://www.ustransplant.org. We believe this method of quantifying additional
donors will provide an appropriate incentive for OPOs to recover donors
that do not fall under the current definition of ``eligible death,''
while ensuring that OPOs with a low number of potential additional
donors are not disadvantaged.
Comment: A national association representing transplant physicians
and surgeons commented that requiring OPOs to add DCDs and ECDs to the
numerator but not the denominator of the conversion ratio would provide
an incentive for OPOs to recover DCD and ECD organs preferentially,
resulting in fewer extra-renal organs available for transplantation.
(The association pointed out that the number of organs transplanted per
donor for DCDs is 2.04 compared to 3.62 for non-DCDs, which suggests
that kidneys are often the only organs transplanted from DCDs.)
Additionally, the association stated that because kidneys from DCDs are
more likely than kidneys from other donors to have delayed graft
function, and livers from DCDs have a lower graft survival rate,
transplant recipients' health would be affected. The association also
contended in its comments that the goal of increasing the supply of
organs from DCDs and ECDs is not consistent with the goal of the CMS
proposed conditions of participation for transplant centers (published
February 4, 2005, 70 FR 6140), which seek to optimize transplant center
patient and graft survival. The association suggested that we require
OPOs to meet all five (instead of only four) proposed outcome measures
to ensure that an OPO would be required to meet the measure for extra-
renal organs transplanted. The association stated that DCDs and donors
over the age of 70 should not be added to either the numerator or the
denominator of the conversion rate ratio. However, the association
qualified this statement by adding that if DCDs and ECDs are not
excluded from the ratio, they should be added to both the numerator and
denominator of the donation rate ratio.
Response: We understand the commenter's concerns and agree that the
goals of the OPO and transplant center rules should be closely aligned.
Although we want to provide an incentive for OPOs to recover organs
from ECDs and DCDs, we certainly do not want such an incentive to lead
to fewer extra-renal organs available for transplantation or to poorer
outcomes for transplant recipients. As stated in our previous response,
under this proposed rule, when an OPO recovers an ``additional donor,''
that is a deceased donor over age 70 or a DCD donor, a ``1'' will be
added to both the numerator and the denominator of the donation rate
ratio. We believe weighting the data in this manner creates an
appropriate incentive for OPOs to recover organs from additional
donors, which will make more kidneys and extra-renal organs available
for transplantation and create more options for transplant recipients
who might otherwise not receive an organ.
Second Outcome Measure: Observed/Expected Donation Rate
Comment: Many commenters praised the innovative analytic work
conducted by the SRTR to improve donation rate measurement, including
the SRTR's efforts to identify ``eligible deaths'' and expected
donation rates for each OPO's DSA. Commenters voiced strong support for
adopting the SRTR's statistical methodology for evaluating OPO
performance for re-certification purposes. Commenters said that using
the SRTR measure would provide an independent statistical assessment of
how OPOs perform relative to their own service area capabilities, such
as the presence or absence of large hospitals and trauma centers.
Commenters also pointed out that including the SRTR methodology would
provide an approach grounded in science similar to our proposed use of
the SRTR statistical methodology for transplant centers, which we
proposed using for approval and re-approval of OPOs. Commenters said
that using the SRTR methodology in conjunction with a national
conversion rate would mean that OPOs would be evaluated both in
comparison to other OPOs, as well as in comparison to each OPO's
statistically expected performance.
Response: The SRTR methodology can be used to determine the
expected organ donation rate in a DSA based on the following hospital
characteristics: Level I or Level II trauma center, metropolitan
statistical area size, CMS case mix index, total bed size, number of
ICU beds, primary service, presence of a neurosurgery unit, and
hospital control/ownership. An adjustment is made for the expected
notification rate. (A Ojo, R Wolfe, A Leichtman, et al; A Practical
Approach to Evaluate the Potential Donor Pool and Trends in Cadaveric
Kidney Donation, Transplantation, Vol. 67, No. 4, February 27, 1999 and
A Ojo, R Pietroski, K O'Connor, et al; Quantifying Organ Donation Rates
by Donation Service Area, American Journal of Transplantation 2005; 5
(Part 2).) Several commenters pointed out that OPOs and hospitals now
use the SRTR statistical methodology in evaluating their own
performance and that the SRTR methodology is used in the Collaborative.
We agree with the commenters that the SRTR statistical methodology
for evaluating OPO performance should be used by CMS for re-
certification of OPOs. In fact, since the SRTR methodology incorporates
specific characteristics of the hospitals in an OPO's service area,
utilizing the SRTR methodology will satisfy the requirement in the OPO
Certification Act for considering ``other related factors in each
service area'' in OPO re-certification. Therefore, under this final
rule, one of the three outcome measures for OPOs is as follows: the
observed donation rate is not significantly lower
[[Page 31003]]
than the expected donation rate (hospital characteristics, notification
rate) for 18 months or more of the 36 months of data included from the
re-certification cycle, as calculated by the SRTR.
Comment: Commenters who recommended that CMS use the SRTR
methodology also suggested that refinements should be made to the
methodology and the donation (conversion) rate measures before the
methodology is used for re-certification of OPOs. Commenters said that
the SRTR should: (1) Review patient-specific data for refining the
methodology, (2) incorporate DCDs and ECDs into its methodology; (3)
review the statistical analysis for an entire 4-year period (since the
data collection did not begin until September of 2001); (4) address the
effect of statistical bias created by the use of dated International
Classification of Disease codes on the organ-specific donation rates
first published by the SRTR in January 2005; and (5) independently
validate inter-OPO reporting of data and the impact of an outcomes
approach heavily reliant on referral data.
Response: The SRTR methodology is defined and will not change. The
data to which the models are applied will be updated to the relevant
time period, and the weighting (coefficients) of the parameters
(variables) in the model will be adjusted to best fit the data. Each
OPO will be adjusted in the same way so that all OPOs are adjusted to
national data.
Comment: Some commenters recommended that when we determine an
OPO's performance, we also determine whether the OPO's outcomes are
statistically significant at p<.01. That is, to determine inadequate
performance, an OPO's outcome must fall below the threshold and be
statistically significantly lower than the performance of other OPOs.
Response: The SRTR publishes data on its Web site showing the
observed and the expected donation rate for each OPO, including a
standardized ratio; p-value; whether the observed donation rate is
statistically lower, higher or not significantly different; and the
lower and upper confidence intervals. A ratio above 1.0 indicates that
the observed measure for an OPO is greater than what would be expected
based on the national experience, while a ratio below 1.0 indicates
that the observed measure for an OPO is less than what would be
expected. The 95 percent confidence intervals of the ratios, which are
published on the SRTR's Web site, describe the uncertainty of the
estimated expected measures and vary by DSA, depending on the amount of
data and the variability within the data. The p-value is a test for
statistical significance between the observed and expected measures.
The p-value is an indication of whether a given result represents a
genuine difference or if it could be due to random chance. A p-value of
less than or equal to 0.05 indicates that the difference between the
observed and expected is probably a genuine difference and is not due
to random chance, and a p-value greater than 0.05 indicates that the
difference could be due to random chance. A p-value of 0.05 is utilized
in the same manner in the SRTR's statistical methodology for evaluating
transplant center performance.
Third Outcome Measure: Organs Transplanted Per Donor
Comment: Many commenters said that the adoption of a ``yield''
measure (organs transplanted per donor) more fully meets the
legislative expectation of multiple measures; is consistent with the
recently launched HHS Organ Transplantation Initiative; provides
incentives for greater recovery and transplantation of extra-renal as
well as renal organs; and allows for incorporation of legislative
expectations regarding pancreas recovery for islet cell transplantation
and research. Further, commenters pointed out that unlike the four
proposed organ-related conversion rates, the unit of analysis is the
donor rather than a self-reported eligible donor population.
Response: We agree that a ``yield'' measure should be added to our
outcome measures for evaluation and re-certification of OPOs in the
future. The number of organs transplanted per donor is an invaluable
measure of OPO performance that has been used successfully by the
Collaborative. The measure goes beyond simply quantifying the number of
donors or the number of organs recovered from donors, by assessing
donor quality based on the number of organs that can be used for
transplantation. Clearly, transplantation of viable organs is the
ultimate goal of organ procurement, and we believe that OPOs should be
able to demonstrate that they have performed well in this regard.
Therefore, we have included in this final rule an outcome performance
measure for the number of organs transplanted per donor. We have
revised proposed Sec. 486.318 accordingly. In this final rule at
486.318(a)(3) we require that at least 2 out of the 3 following
measures are no more than 1 standard deviation below the national mean,
averaged over 3 years during the re-certification cycle: (1) Number of
organs transplanted per standard criteria donor, including pancreata
used for islet cell transplantation; (2) Number of organs transplanted
per expanded criteria donor, including pancreata used for islet cell
transplantation; and (3) Number of organs used for research per donor,
including pancreata used for islet cell research. The first two
measures are calculated by dividing the number of organs transplanted
by the number of donors (either SCDs or ECDs). The third measure is
calculated by dividing the number of organs used for research by the
total number of donors (all donor types). Although we are establishing
the thresholds for the outcome measures as we described earlier in this
preamble, we will reconsider the appropriateness and the validity of
the thresholds every 4 years when we review and analyze data from the
previous re-certification cycle. If overall OPO performance improves
and the mean increases, as we expect, we may find that OPOs that do a
good job are falling below a threshold established by this final rule.
If so, we will consider whether the threshold should be lowered.
Conversely, if we find that a threshold established by this final rule
is so low that it provides no incentive for OPOs to excel, we will
consider whether to raise the threshold.
We will continue to monitor the OPOs performance under the third
outcome measure. In the future (after the first agreement cycle), we
may seek to make the standard more stringent if that appears warranted.
We would only make this change after obtaining public comment through a
separate rulemaking.
Comment: Some commenters suggested that each recovered pancreas
used for islet cell transplantation or research should be added to the
numerator and denominator of the organs transplanted per donor rate
ratio for each individual OPO. One commenter pointed out that the
pancreas adjustment would provide appropriate incentives for OPOs to
recover pancreata for islet cell transplantation or research and would
be consistent with the Pancreatic Islet Cell Act of 2004, which
requires CMS to count pancreata used for islet cell transplantation and
research towards an individual OPO's performance for re-certification
purposes.
Response: We agree with the commenters' suggestion to include
pancreata used for islet cell transplantation in the organs
transplanted per donor outcome measure. In view of the variability in
recovery of pancreata across the nation, adjusting an individual OPO's
organs transplanted per donor rate for
[[Page 31004]]
pancreata recovered for islet cell transplantation, rather than adding
these pancreata to the national mean, weights these data appropriately.
Thus, in this final rule, we specify that for the organs transplanted
per donor outcome measure, ``organs'' include pancreata used for islet
cell transplantation. However, we do not agree that it is appropriate
to include pancreata used for islet cell research in the organs
transplanted per donor measure. We believe the measure should reflect
only organs that were used for transplantation.
In this final rule, we are adding an additional yield measure for
organs used for research, which is discussed below. By including
pancreata that are used for islet cell research in this measure, the
pancreata will be counted for re-certification purposes, pursuant to
the Pancreata Islet Cell Transplantation Act, and it will also provide
an incentive to OPOs to procure pancreata for islet cell research. We
believe that this is the most appropriate measure we can use to account
for pancreata used in islet cell research.
Comment: Many commenters recommended that a case-mix expected rate
be incorporated into the outcome performance measure for organs
transplanted per donor. One commenter stated that case-mix adjusting
would account for important variations reflecting types of donors, as
well as the age and race of donors, and would allow for appropriate
incentives to OPOs to recover organs from all donors without worrying
about the negative impact on their performance. A commenter stated that
the use of such an approach for outcome performance purposes would
provide a sounder analytic basis than using unadjusted measures to make
inter-OPO assessments. The commenter pointed out that under the
Collaborative, HHS has identified individual, organs-transplanted-per-
donor goals for the three different types of donors: donors after
cardiac deaths (DCDs), expanded criteria donors (ECDs), and standard
criteria donors (SCDs).
Response: We agree that there are variations in the number of
organs transplanted per donor, depending upon the donor type, that is,
DCD, ECD, or SCD. Since currently there is no methodology for case-mix
adjusting the number of organs transplanted per donor, in this final
rule, we have included within the outcome measure for organs
transplanted per donor two subgroups of donors: the number of organs
transplanted per ECD and the number of organs transplanted per SCD. We
have not included the number of organs transplanted per DCD because we
do not want to disadvantage OPOs that do not recover organs from such
donors. The current definition for an ``expanded criteria donor'' or
``ECD'' used by the OPTN is a donor who is over 60 years of age, or who
is between 50 and 59 years of age and meets two of the following three
conditions: died of a stroke, had a history of hypertension, or had a
serum creatinine of greater than 1.5. Note that we are not finalizing a
definition for ECD in this final rule because we believe the definition
for ECD will change over time in response to changes in transplant
technology.
It is important to note that OPOs will be required to meet only 2
out of the 3 yield measures at the 1 standard deviation below the mean
threshold for each subgroup.
Third Outcome Measure: Organs Used for Research Per Donor
Comment: Some commenters urged CMS to count all organs recovered
for research in the outcome measures for OPOs. One commenter noted that
organs that are not suitable for transplantation may aid researchers in
developing experimental techniques that could assist in reducing the
transplant waiting list. A researcher wrote to say that his research on
a cellular-based treatment for liver disease is nearing the clinical
trial phase but that a limiting factor for the speed of entry into
human clinical trials is access to tissue from organs. The researcher
commented that tissue from organs for research would not be limited if
every OPO made the same effort as the highest performing OPOs to
recover organs for research. He pointed out that in 2003, there were
6455 deceased donors and 5348 liver transplants. Of the 1107 livers
that were not transplanted, only 168 were sent for research. The
researcher also said that OPOs have told him that there is no incentive
for OPOs to recover and place organs for research because their
standard acquisition charge is reduced by the amount the OPO receives
for the organ. This commenter suggested that we establish within the
outcome measures, a measure for consent rate for organs recovered for
research.
Response: We agree overall with the commenters' recommendations.
Like organs for transplantation, organs for research are a precious
national resource. We believe OPOs should recover organs for research
whenever possible to aid researchers looking for new therapies for
debilitating and fatal diseases, many of them the same diseases that
cause end-stage organ failure in patients waiting for transplants.
Although recovering organs for research is not an OPO's primary
mission, the organs it places with researchers may help lead to
treatments or cures that will reduce the transplant waiting list as
surely as organs that are used for transplantation.
We believe that providing an incentive for OPOs to recover organs
for research will increase the number of organs available to
researchers throughout the country. However, we believe measuring how
many organs an OPO actually places for research is a more useful
measure than the rate of consent to donating organs for research. Thus,
the third OPO outcome performance measure (the ``yield'' measure) for
OPOs that do not operate exclusively in non-contiguous U.S. states,
commonwealths, territories, and possessions will include a measure of
the number of organs used for research (including organs used for islet
cell research) per deceased organ donor. The policy is consistent with
the Pancreatic Islet Cell Transplantation Act, which requires that
pancreata used for islet cell research be counted for OPO
certification. When determining the number of organs ``used'' for
research, we will consider any organ that an OPO sends to an individual
or organization for research purposes as having been used for research.
Nevertheless, while recovering organs for research is vitally
important, we do not want OPOs to recover organs for research at the
expense of organs for transplantation. An OPO's primary mission is to
maximize the number of viable organs it recovers and places for the
purpose of transplantation. To ensure that OPOs focus on this mission,
we have weighted the overall yield measure toward recovering organs for
transplantation. That is, there are two sub-measures for organs for
transplantation (number of organs transplanted per SCDs, ECDs) and only
one sub-measure for research organs (number of organs recovered for
research per deceased donor).
OPOs That Serve Non-Contiguous Areas
Comment: Some commenters recommended different performance
standards for Puerto Rico and Hawaii. A national association that
represents all of the OPOs suggested the following outcome measures for
Puerto Rico and Hawaii: (1) Thresholds of 50 percent of the national
mean, instead of 75 percent, for both conversion rate and organs
transplanted per donor; (2) an organs transplanted per donor measure
based only on kidneys recovered per donor; and (3) that a national mean
be calculated for kidneys recovered per
[[Page 31005]]
donor solely for the purpose of determining if Puerto Rico and Hawaii
exceed 50 percent of the national mean. That association also suggested
that these be the only outcome measures for Puerto Rico and Hawaii.
Response: We have historically used different performance standards
for OPOs that operate exclusively in non-contiguous States,
territories, and commonwealths. The performance standards in the
existing regulations require such OPOs to meet only two performance
standards (kidneys recovered and kidneys transplanted) and to meet them
at only 50 percent of the national mean. These differences recognized
that OPOs operating exclusively in non-contiguous locales have fewer
options for placing organs because they have fewer transplant centers
(particularly extra-renal transplant centers) and may be located too
far from the continental United States for the viability of extra-renal
organs (including pancreata used for islet cell transplantation or
research) to be maintained until transplantation can take place.
Therefore, under this final rule, we set forth the following
outcome measures for OPOs operating exclusively in non-contiguous U.S.
States, commonwealths, territories, or possessions: (1) The OPO's
donation rate of eligible donors as a percentage of eligible deaths is
no more than 1.5 standard deviations below the mean national donation
rate of eligible donors as a percentage of eligible deaths, averaged
over 3 years during the re-certification cycle. Both the numerator and
denominator of an individual OPO's donation rate ratio are adjusted by
adding a 1 for each donation after cardiac death donor and each donor
over the age of 70; (2) the observed donation rate is not significantly
lower than the expected donation rate for 2 or more years of the 4 year
re-certification cycle, as calculated by the SRTR; and (3) at least 2
out of the 3 following measures are no more than 1 standard deviation
below the national mean, averaged over the 3 years during the re-
certification cycle:
The number of kidneys transplanted per standard criteria
donor;
The number of kidneys transplanted per expanded criteria
donor; and
The number of organs used for research per donor,
including pancreata used for islet cell research.
Performance Thresholds
Comment: Many commenters recommended the following specific
thresholds for inadequate performance by an OPO that does not serve
only non-contiguous areas:
Not achieving 75 percent of the mean overall donation
rate, and
Having a SRTR-based donation rate for at least 3 years of
the 4-year cycle statistically lower than expected, and
Not achieving 75 percent of a case-mix expected organs per
donors transplanted measure.
Response: We agree in theory with the commenters' recommendation
for the second measure (a ratio of the observed donation rate/expected
donation rate that is not significantly lower than expected for at
least 2 years out of the 4-year re-certification cycle) is reasonable.
(We have finalized this as a ratio of the observed donation rate/
expected donation rate that is not significantly lower than expected
for at least 18 months out of 36 months, because we are using a lesser
amount of data.) However, we disagree with the commenters that an OPO's
performance is not adequate if it has not achieved 75 percent of the
mean national donation rate and 75 percent of the organs transplanted
per donor measure.
Historically, we have used a threshold of 75 percent of the
national mean for the OPO performance standards. (See 42 CFR
486.310(b).) However, we believe that using standard deviations
provides more statistical validity and ensures that OPOs screened out
for de-certification are outliers. We believe this threshold screens
out OPOs that are not effective yet takes into consideration the
likelihood that the national mean will continue to rise, as well as the
fact that each OPO's performance on the outcome measures is based on a
relatively small number of donors and organs. Therefore, rather than
using a percentage threshold, we are adopting a statistically-based
threshold. In this final rule, to meet the donation rate outcome
measure and the ``yield'' measure of organs transplanted per donor/
organs used for research per donor, an OPO's performance must be at or
above 1.5 standard deviations below the mean national rate for the 3
years during the re-certification cycle for the donation rate measure
and at or above 1 standard deviation below the mean national rate for
the 3 years during the re-certification cycle for the yield measure.
Under this final rule, an OPO's donation rate of eligible donors as
a percentage of eligible deaths must be no more than 1.5 standard
deviations below the mean national donation rate of eligible donors as
a percentage of eligible deaths, averaged over the 3 years during the
re-certification cycle. Both the numerator and denominator of an
individual OPO's donation rate ratio are adjusted by adding a 1 for
each donation after cardiac death donor and each donor over the age of
70. (See Sec. 486.318(a)(1).)
As discussed above, we are not adopting a case-mix-expected organs
per donor transplanted measure because the SRTR currently does not case
mix adjust this measure. However, we are adopting separate organs
transplanted per donor measures for SCDs and ECDs, as well as a measure
for the number of organs used for research per donor. OPOs will be
required to meet 2 out of 3 of these measures at no less than 1
standard deviation below the mean national rate for the following:
organs transplanted per donor for SCDs, organs transplanted per donor
for ECDs, and organs used for research per donor. (See Sec.
486.318(a)(3).) Therefore, we have established a threshold of 1.5
standard deviations below the national mean for the donation rate
outcome measure and 1 standard deviation below the national mean for
the yield measure.
General
Comment: Some commenters said that OPOs should suffer no
reimbursement consequences if they procure organs that are not accepted
for transplantation. Since an OPO's costs for procuring these organs
are added to its overall standard acquisition charge for organs, its
costs are passed through to transplant hospitals and the Medicare
program.
Response: Medicare payment policy and OPO standard acquisition
charges are beyond the scope of this regulation. We are not making
changes to the final rule based on this comment.
Condition: Participation in Organ Procurement and Transplantation
Network (Proposed Sec. 486.320)
The February 4, 2005 proposed rule included language to clarify
that an OPO becomes a member of the OPTN only after becoming designated
by CMS. We proposed requiring that after being designated, an OPO must
become a member of, and abide by the rules and requirements of the OPTN
established and operated in accordance with section 372 of the Public
Health Service Act (42 U.S.C. 274). (The term ``rules and requirements
of the OPTN'' means those approved by the Secretary.) We are adopting
this section with one change, which is discussed below.
Comment: A few commenters pointed out that the Public Health
Service Act requires OPOs to ``participate in the OPTN'' (42 U.S.C
273(b)(3)(H)). They suggested including this phrase in the requirements
for OPTN membership.
[[Page 31006]]
Response: We agree with the commenter. Therefore, we have revised
Sec. 486.320 to require OPOs to participate in the OPTN.
Condition: Relationships With Hospitals, Critical Access Hospitals, and
Tissue Banks (Proposed Sec. 486.322)
We proposed three standards for this condition of participation.
For the standards regarding hospital agreements, we proposed that an
OPO must have a written agreement with 95 percent of the hospitals and
critical access hospitals in its service area that have both a
ventilator and an operating room and have not been granted a waiver by
CMS to work with another OPO. With regard to training, we proposed that
the OPO must offer designated requestor training on at least an annual
basis for hospital and critical access hospital staff. Finally, we
proposed a standard regarding cooperation with tissue banks that
specified the OPO must have arrangements to cooperate with tissue banks
that have arrangements with hospitals and critical access hospitals
with which the OPO has agreements. We are implementing this section
with some changes, which are discussed in detail below.
We received many comments on this proposed condition of
participation, particularly on the subsection requiring cooperative
arrangements with tissue banks. Overall, commenters approved of our
proposal to require agreements with 95 percent of hospitals with a
ventilator and an operating room. We received only a few comments on
our proposal to require OPOs to offer designated requestor training
annually, and commenters strongly disagreed with our proposal to
require OPOs to have cooperative agreements with tissue banks.
Comment: One commenter said that we should require OPOs to have
agreements with 100 percent (not just 95 percent) of the hospitals in
their service areas with a ventilator and an operating room.
Response: We believe that it would be optimal for OPOs to have
agreements with 100 percent of the hospitals in their service area that
have a ventilator and an operating room. However, as we stated in the
preamble to the proposed rule, the PHS Act requires only that an OPO
have agreements with a ``substantial majority'' of the hospitals in its
service area that have facilities for organ donation. Therefore, we
proposed maximizing the number of hospitals with which OPOs have
agreements (consistent with the PHS Act) by requiring OPOs to have
agreements with 95 percent of the hospitals and critical access
hospitals in their service areas that have both a ventilator and an
operating room. (Note: If a hospital received a waiver from us to work
with another OPO, the hospital would not be counted as part of the
OPO's service area.) We reasoned that because it is necessary for a
hospital to have a ventilator to maintain a potential donor and an
operating room for recovery of organs, we believe a requirement for
OPOs to have agreements with 95 percent of hospitals and critical
access hospitals with a ventilator and an operating room would capture
a ``substantial majority'' of hospitals with facilities for organ
donation. For these reasons, we are adopting the requirement that OPOs
have agreements with 95 percent of the qualifying hospitals in their
service area, as proposed.
Comment: One commenter pointed out that currently OPOs are required
to have agreements with only 75 percent of the Medicare and Medicaid
hospitals in their service areas. The commenter said that there is no
reason to make a change. Another commenter suggested that OPOs should
be required to have agreements only with hospitals that have 150 or
more acute care beds with an intensive care unit and a ventilator or
with a Level I or Level II trauma center.
Response: We disagree that OPOs should be required to have
agreements with only 75 percent of the Medicare and Medicaid hospitals
in their service areas that have an operating room and the equipment
and staff to maintain a potential organ donor, as required under the
current regulations. We also disagree that OPOs should be required to
have agreements only with hospitals that have 150 or more acute care
beds with an intensive care unit and a ventilator or with a Level I or
Level II trauma center.
We acknowledge that many hospitals in an OPO's service area do not
have a high potential for organ donation. Nevertheless, it is important
for OPOs to work with these hospitals to develop appropriate agreements
to define terms, ensure that all deaths and imminent deaths are
referred to the OPO, and address how the organ donation process will
occur, so that when hospitals have potential donors, the organ donation
process proceeds smoothly and organ donation is maximized. The success
of the Collaborative has proven that organ donation will increase in
hospitals where hospital leaders and OPOs have worked together to
develop comprehensive, functional agreements that spell out the roles
and responsibilities of all parties in the donation process.
Comment: A commenter voiced support for including a requirement
that OPOs' agreements with hospitals define both ``imminent death'' and
``timely referral.'' Another commenter said that we should change the
term ``imminent death'' to ``clinical triggers,'' because many OPOs and
hospitals across the country are using the term ``clinical triggers''
to define the point in time when a hospital should contact the OPO
about a patient whose death may be imminent.
Response: We have no objection to OPOs using the term ``clinical
triggers'' in their agreements with hospitals. The term has been widely
used among OPOs and hospitals participating in the Collaborative as a
substitute for the term ``imminent death.'' However, the regulatory
text of this final rule includes the term ``imminent death'' because it
is the term used in Sec. 482.45, Hospital Condition of Participation
for Organ, Tissue, and Eye Procurement, which requires hospitals to
report all deaths and imminent deaths to an OPO. Therefore, we would
advise OPOs when using the term ``clinical triggers'' in their
agreements to include the term ``imminent death'' as well, so that a
surveyor reviewing an agreement between an OPO and a hospital can
determine that the OPO has met the requirement to include the
definition of ``imminent death.''
Comment: A commenter asked for clarification regarding the
information an OPO will need to have on hand to show a surveyor that it
tried but failed to sign an agreement with a hospital in its service
area.
Response: Following publication of this final rule, CMS will
develop Interpretive Guidelines for OPO surveyors that will include
such specific details. However, we would expect an OPO to be able to
show due diligence in attempting to meet this requirement, such as
copies of written requests for meetings with hospital leadership,
letters to the hospital administration, or documentation of telephone
calls and other contacts with hospital decision makers.
Comment: One commenter stated that our proposal to require OPOs to
offer designated requestor training on at least an annual basis
conflicts with Sec. 482.45, which states that designated requestor
training should be provided if it is requested by the hospital.
Response: We did not propose requiring OPOs to provide designated
requestor training annually for their hospitals. However, because the
commenter misunderstood the proposed
[[Page 31007]]
language, we have clarified that the OPO is required only to offer to
provide designated requestor training annually. If a hospital does not
want designated requestor training for its staff, the OPO is not
required to provide it. We have revised Sec. 486.322(b) accordingly.
Comment: A commenter said that requiring designated requestor
training conflicts with demonstrated best practices (such as the best
practices of the Collaborative), which emphasize the importance of a
partnership between the OPO representative and hospital staff.
Response: Effective requestors also receive training from OPOs,
although the training may take place in real time and not in a
classroom setting. Therefore, if an OPO partners with hospital staff
and, as a team, the OPO and hospital staff discuss and determine the
most appropriate way to approach a potential organ donor family to
request consent, the hospital staff are considered trained designated
requestors for the purposes of this regulation. We have added language
to the proposed definition of ``designated requestor'' to clarify that
the terms ``designated requestor'' and ``effective requestor'' are
interchangeable.
Comment: One commenter said that we should require OPOs to include
tissue and eye agency staff when designated requestor training is
provided to a hospital.
Response: The hospital CoP for organ, tissue, and eye procurement
at Sec. 482.45 requires hospitals to assure that designated requestor
training is ``designed in conjunction with the tissue and eye bank
community.'' This final rule requires OPOs to cooperate with tissue
banks in providing designated requestor training. This means that if an
OPO provides designated requestor training to a hospital, and the
hospital or a tissue bank with which the hospital has an agreement asks
the OPO to include the tissue bank in the training, the OPO must
provide an opportunity for the tissue bank to participate in the
training. We have added language to Sec. 486.322(c) that requires OPOs
to cooperate with tissue banks in offering designated requestor
training.
Comment: Many commenters said that we should not require an OPO to
have an arrangement with a tissue bank if the OPO does not agree with
the tissue bank's practices. Some OPOs commented that they do not want
to be associated with such tissue banks for a variety of reasons,
including the possibility of legal liability. Many of the OPOs that
commented expressed a willingness to act as a gatekeeper for hospital
referrals and pass those referrals to the hospital's tissue bank(s).
However, commenters said they should not be required to cooperate with
such a tissue bank in obtaining consent from families (in the absence
of a donor document) or in the retrieval, processing, preservation,
storage, or distribution of tissues.
Response: In developing this subsection for the final rule, we took
into consideration three factors: (1) An OPO's role as the agency that
receives most referrals of deaths and imminent deaths from the
hospitals in its service area (unless referrals are screened by a
third-party designated by the OPO); (2) the need to show sensitivity
toward the circumstances of potential organ and tissue donor families
(such as, ensuring that potential donor families are not approached by
more than one agency unnecessarily); and (3) the statutory requirement
that an OPO have arrangements to cooperate with tissue banks to assure
that all useable tissues are obtained.
The hospital CoP for organ, tissue, and eye procurement at Sec.
482.45, which went into effect in August 1998, requires hospitals to
refer all deaths and imminent deaths (rather than just potential organ
donors) to an OPO or a third party designated by the OPO. Critical
access hospitals also have a CoP for organ, tissue, and eye
procurement. (See Sec. 485.643.) The hospital and critical access
hospital CoPs state that in the absence of alternative arrangements
between a hospital and a tissue bank, the OPO will determine
suitability for tissue donation. It has been our experience that very
few hospitals have been willing to have alternative arrangements that
would require them to make two phone calls: one to the OPO to report a
death or imminent death and one to the tissue bank to report a
potential tissue donor. Thus, in most areas of the country, OPOs became
the de facto gatekeepers for information about potential tissue donors
even though our regulations permit alternative arrangements.
The PHS Act, as well as the existing regulations for OPOs at Sec.
486.308(i), require OPOs to have ``arrangements to cooperate with
tissue banks for the retrieval, processing, preservation, storage, and
distribution of tissues as may be appropriate to assure that all
useable tissues are obtained from potential donors.'' Cooperation
between OPOs and tissue banks often results in more efficient
operations, such as shared referral lines for hospitals to use when
calling about deaths and collaboration between OPOs and tissue banks in
training hospital designated requestors. Further, as we stated in the
preamble to the proposed rule, collaboration and cooperation between
donation organizations promote a positive public opinion about
donation.
Recent years have seen significant growth in the number of OPOs
that have their own tissue banks or that have agreements with a
specific tissue bank to provide various services, such as obtaining
consent on behalf of the tissue bank or recovering tissue. In some
cases, this flexibility has worked well, but in other areas, the
increased involvement of OPOs in tissue banking has created tension
between certain OPOs and the tissue banks in their service areas. It is
clear that because of an OPO's role in regard to hospital referrals, we
must ensure that the OPO cooperates in the screening and referral of
potential tissue donors. Thus, as we proposed at 486.322(c), when an
OPO receives a referral of a death or an imminent death from the
hospital with which it has an agreement, the OPO must cooperate with
the tissue bank with which the hospital has an agreement to ensure that
the referral is screened for tissue donation potential and, as
appropriate, referred to the tissue bank.
Additionally, as proposed at 486.322(c)(ii), an OPO must cooperate
with tissue banks with which a hospital has an agreement in obtaining
informed consent for tissue donation. Note that the OPO is not required
to request tissue donation on behalf of a tissue bank that does not
have an agreement with the hospital.
Under the PHS Act at section 371(b)(3)(I), an OPO is required to
have arrangements to cooperate with tissue banks in the ``retrieval,
processing, preservation, storage, and distribution of tissues as may
be appropriate to assure that all useable tissues are obtained from
potential donors.'' The proposed rule has a similar requirement at
proposed Sec. 486.322(c)(iii). Although we are finalizing our
requirement as proposed, we are clarifying that this requirement does
not obligate an OPO to have arrangements with the tissue bank with
which the hospital has an agreement (or with any other tissue bank) to
collaborate or cooperate with the tissue bank routinely in the
``retrieval, processing, preservation, storage, and distribution of
tissues.'' An OPO's mission is recovering and distributing organs, not
recovering, processing, preserving, storing, or distributing tissues.
We do not believe it would be appropriate to require an OPO to engage
in these activities on a regular basis. Therefore, a tissue bank should
make its own arrangements for these activities, without relying on the
OPO.
[[Page 31008]]
Comment: One commenter said that CMS should request information
directly from tissue banks about OPOs, for example, by sending an
annual questionnaire to the tissue banks and eye banks working in
conjunction with the OPO. The commenter said that as the Federally
mandated OPO, an OPO has a responsibility to provide services to all
their customers in the community, including tissue banks and eye banks.
Response: OPOs are responsible for cooperating with the tissue
banks and eye banks with which the hospitals in its service area have
agreements. Such a tissue bank (or eye bank) that believes an OPO is
not cooperating, as required by the OPO regulations, should contact us,
and we will assess the situation to see if the OPO has violated a
regulatory requirement. However, we are not requiring OPOs to provide
services to all the tissue banks and eye banks in their service areas
or sending an annual questionnaire to each tissue bank.
Comment: One commenter said that when determining whether an OPO is
creating a spirit of cooperation and collaboration, we should look at
the issue of referral fees and timely access to data. The commenter
described a situation in which an OPO that uses a third party to answer
referral calls from hospitals has refused to provide timely access for
tissue banks and eye banks to referral calls and other information.
Thus, the tissue banks and eye banks were forced to contract with an
alternate third party to gain access to needed information. The
commenter said that as a result, the tissue banks and eye banks are
forced to pay a referral fee both to the OPO and to the alternate third
party.
Response: As we stated in our previous response, if we receive a
complaint from a tissue bank about an OPO that involves hospital
referrals and/or the OPO's gatekeeper function, we assess the situation
to see if a regulatory requirement has been violated. We have made no
change in the regulations text in response to this comment.
Comment: A commenter suggested that CMS should hold OPOs
accountable for obtaining consents on behalf of tissue banks by
tracking their consent rates for tissues and making this information
public. The commenter said that some OPO procurement coordinators
choose not to ask families to donate tissue because they believe such a
request may cause a family to say no to organ donation.
Response: An OPO's primary mission is organ donation; therefore, we
have no plans to track OPOs' tissue consent rates. As stated earlier,
this final rule requires OPOs to cooperate with tissue banks that have
agreements with the hospitals with which the OPO has agreements to
obtain informed consent from families of potential tissue donors.
Further, this final rule at Sec. 486.42(a) requires OPOs to ensure
that ``in the absence of a donor document, the individual(s)
responsible for making the donation decision are informed of their
options to donate organs or tissues * * *.''
Comment: A commenter requested clarification of proposed Sec.
486.322(c)(2), ``An OPO is not required to have an arrangement with a
tissue bank that is unwilling to have an arrangement with the OPO.''
The commenter said that regulations must be established that would
verify that unreasonable obstacles were not created by the OPO to
create an unwillingness to have an arrangement in an effort to keep
certain tissue banks out of the hospital. The commenter suggested that
we should strengthen the proposed language to say that an OPO ``must
make every reasonable effort to have an arrangement with all tissue
banks that serve their hospitals.''
Response: We are not parties to the agreement, and our regulations
do not specify the precise terms of any agreement between an OPO and a
tissue bank. The parties to the agreement are in the best position to
develop the exact language of the agreement. Our regulations give the
parties the flexibility to establish appropriate procedures without the
government attempting to impose a one-size-fits-all solution. We
included the proposed language to which the commenter refers only to
ensure that OPOs would not be penalized if a tissue bank were unwilling
to have an arrangement with the OPO. We do not agree with the commenter
that we should require OPOs to have a cooperative arrangement with
``all tissue banks that serve their hospitals.'' The suggested language
is ambiguous and could be understood to obligate an OPO to have an
agreement with a tissue bank that does not have an agreement with a
hospital with which the OPO has an agreement. For example, if a tissue
bank has an agreement with a medical examiner or coroner for recovery
of tissue from potential tissue donors who fall under medical examiner
or coroner jurisdiction but does not have an agreement with the
hospital, this final rule does not require the OPO to have a
cooperative arrangement with the tissue bank.
Comment: A commenter said that it would be helpful if CMS could
provide guidance in regard to medical/examiner coroner cases. The
commenter stated that in many instances, a medical examiner or coroner
may have an affiliation with a tissue bank and may refuse to honor a
hospital's agreement with a different tissue bank (or with the OPO) for
tissue donation, choosing, rather to ``assert jurisdiction'' over the
body and pass the referral to its affiliated tissue bank, one not
chosen by the hospital to serve its patients and families.
Response: As stated in our previous response, we do not require an
OPO to have a cooperative arrangement with a tissue bank whose
agreement is not with the hospital but with a medical examiner or
coroner. Moreover, we do not regulate medical examiners or coroners
and, thus, we cannot intervene if a medical examiner or coroner refuses
to honor an agreement that the hospital has with a tissue bank.
Condition: Administration and Governing Body (Sec. 486.324)
We proposed creating a separate condition for coverage for
administration and governing body with a number of new requirements for
membership composition of and bylaws for OPO boards, as well as
requirements for the governing body that would have legal authority and
responsibility for the management and provision of OPO services.
We proposed that an OPO may have more than one board, and we set
forth specific requirements regarding the membership composition of the
board. We proposed making certain changes to the structure and
composition of OPO boards, including prohibiting cross membership
between OPO boards. Other proposals were intended to strengthen
requirements for OPO governance to ensure OPOs have policies and
procedures to address possible conflicts of interest.
We proposed that an OPO may have as many individual boards as it
chooses, but one of its boards must have the specific membership
composition prescribed by the PHS Act and must operate under restraints
similar to those prescribed by the PHS Act for that board, that is the
board that would be limited to recommending policies for the OPO. We
proposed that an OPO must have on its advisory board a tissue bank
representative from a facility not affiliated with the OPO unless the
only tissue bank in the service area is affiliated with the OPO. We
proposed that the board would serve only in an advisory capacity and
could not also serve as the OPO's board of directors or any other OPO
board. We also proposed a requirement for OPOs to have bylaws for each
of its boards to address potential conflicts of interest, length of
[[Page 31009]]
terms, and criteria for selection and removal of members.
We proposed a requirement for OPOs to have a governing body (for
example, a board of directors) that has full legal authority and
responsibility for the management and provision of all services. The
governing body would be responsible for developing and overseeing
implementation of policies and procedures necessary for effective
administration of the OPO, including fiscal operations, a QAPI program,
and services furnished under contract or arrangement, including
agreements for these services. We also proposed a requirement for an
OPO to have a procedure to address potential conflicts of interest for
the governing body. Finally, we asked the public to comment on whether
it would be appropriate for the legal authority and responsibility for
the management and provision of all OPO services to lie with an
individual, rather than a governing body. We are finalizing the
proposed provisions with changes, which are discussed in detail below.
We received numerous comments about our proposals to prohibit cross
membership between governing and advisory boards, to require OPOs to
have a separate advisory board, and to require OPOs to have conflict of
interest policies for their boards and governing bodies. Most
commenters were firmly in support of the spirit of these proposals--
ensuring that all OPOs are administered and governed in a manner that
makes the recovery of viable organs for transplantation the OPOs' first
priority. However, many OPO commenters pointed out that some of our
proposals, such as prohibiting cross representation between boards and
requiring OPOs to have separate advisory boards, would force them to
abandon administration and governance frameworks that they believe work
very well.
Most commenters were in strong agreement with the need for strict
conflict of interest policies. OPO commenters said that by enforcing
their conflict of interest policies zealously, they have managed to
avoid problems with over representation by transplant centers. However,
nearly all commenters disagreed with our proposal to require OPOs to
include as a board member, a representative from a tissue bank not
affiliated with the OPO.
Transplant Center Representation
Comment: Many commenters said they are concerned about the
influence of transplant surgeons and transplant centers on fiduciary
matters. One commenter noted that transplant centers and transplant
surgeons are overwhelmingly concerned with the volume of organs and the
cost of organs to the centers. The commenter said that this
understandable concern makes it difficult for transplant centers and
surgeons who serve on OPO boards to maintain a proper fiduciary
responsibility as OPO board members. The commenter stated, ``They are
often unable to focus on the long term needs and investment
requirements of the OPO and lack the motivation and incentive to
increase costs to their own organizations for the long term well being
of the OPO. Some transplant programs are in arrears on organ
acquisition fees or are willing to tolerate dangerously low financial
reserves for the OPO * * *.''
The commenter suggested that the transplant community should be
permitted to serve on an OPO's advisory board to coordinate clinical
and operational needs and protocols, as well as placement of organs,
but should not be permitted to serve on an OPO's board of directors.
The commenter urged CMS to close the ``huge loopholes'' in the
regulations for OPO boards and predicted that if loopholes are not
closed, there will be national scandals and high profile
investigations.
Another commenter agreed that transplant surgeons and their
representatives and related parties should be restricted from any
involvement in the business affairs of an OPO. Other commenters said
that they welcome the involvement of transplant surgeons and other
transplant center representatives on their boards, including their
boards of directors and other governing bodies.
Response: We do not believe it would be acceptable or in the best
interests of all OPOs to prohibit transplant surgeons from serving on
an OPO's board of directors or an advisory board. Note that in the
proposed rule, we explained that we were proposing to change the PHS
Act term ``transplant center'' to ``transplant hospital'' to clarify
that we do not expect an OPO to have a transplant surgeon from each
individual organ transplant program within a transplant hospital. We
said that since some OPOs have more than a dozen transplant hospitals
in their service areas, a requirement to have a transplant surgeon from
each program within each hospital would result in OPO boards with an
overwhelming number of members. We have finalized this clarification.
Therefore, an OPO needs to have a transplant surgeon from each
transplant hospital but not from each transplant program within the
transplant hospital. This rule is consistent with 42 U.S.C. 274b(d)(1),
which defines the term ``transplant center'' to mean ``a health care
facility in which transplants of organs are performed.''
Comment: One commenter suggested that the CMS regulations for OPOs
should specifically prohibit a board structure that could result in
violations of laws (such as the Stark Amendments) and other regulations
that prohibit fraud and abuse. The commenter added that the
``transplant-dominated groups can easily create excess benefit
transactions and invite intermediate sanctions'' in violation of the
Internal Revenue Service (IRS) rules for non-profit organizations. The
commenter stated, ``The grip of control on the business affairs, charge
structure, financial objectives, professional fees to [transplant
surgeons] and their friends is extremely tight and there are often
threats and intimidation and harassment used against those who want
reform. The high level board committees * * * are often overwhelmingly
controlled by transplant surgeons or their proxies.'' The commenter
also charged that the individuals and organizations ``are already
planning to circumvent the intent of the proposed OPO governance
regulations by simply maintaining control of their executive and
finance committees and have their business associates or other
colleagues appointed to the boards * * *.''
Response: Possible violations of law or regulations by OPO board
members should be reported to the appropriate authority, such as the
IRS, the Department's Office of Inspector General, or CMS. If we
receive a complaint that OPO board members are attempting to circumvent
the requirements for administration and governing body in this final
rule, we will conduct a complaint investigation. A violation of a
regulatory condition for coverage may lead to de-certification.
Comment: Some commenters recommended that we limit the percentage
of governing board members representing transplant hospitals. One
commenter stated that the composition of the OPO's governing body
should provide a balance between lay people and community
representatives on the one hand and transplant professionals on the
other. The commenter recommended that at least 50 percent of the
members of the governing body should not be connected with transplant
hospitals that receive organs from the OPO. Other commenters said that
transplant physicians and surgeons should comprise less than 50 percent
of the membership of the governing board.
[[Page 31010]]
One commenter predicted that such a limitation on transplant center
representation, in conjunction with enhanced conflict of interest
provisions, would allow for adequate protection from conflicts and
simultaneously maintain the necessary consultation and input from the
members represented on the advisory board.
Response: By statute, the board of directors or an advisory board
is composed of a variety of parties with particular perspectives on
organ procurement. A transplant surgeon for each transplant hospital
(termed ``transplant center'' in the statute) in the service area is a
statutory requirement. Some of the requested changes would require
additional legislation and are beyond the scope of this regulation.
Further, we believe that generally an OPO should have the flexibility
to decide the composition of its boards and governing body based on its
particular needs, as long as the OPO complies with statutory and
regulatory requirements.
Comment: One commenter addressed our proposal to clarify that the
OPO's advisory board should have a transplant surgeon from each
transplant hospital and said that instead the requirement should be
that there must be a transplant surgeon from each ``unique UNOS
transplant center'' because a single center may contain a number of
hospitals.
Response: We proposed changing the current requirement for an OPO
to have a transplant surgeon from each transplant center on its board
to a requirement for an OPO to have a transplant surgeon from each
transplant hospital in keeping with our definition of ``transplant
hospital'' in Sec. 486.302. We said in the preamble to the proposed
rule that although ``transplant hospital'' and ``transplant center''
are often used interchangeably, the term ``transplant center''
sometimes is used to refer to an individual transplant program (such as
a heart transplant program or liver transplant program) within a
hospital that performs transplants. While the PHS Act specifies that an
OPO must have a transplant surgeon from each transplant center on its
board, we said that we did not consider a ``transplant center'' to be a
program for transplantation of a single organ type but a hospital that
performs transplants. Thus, we proposed a change in language to clarify
that even if a hospital has multiple transplant programs, the OPO need
have only one transplant surgeon per transplant hospital. We have
included this language in the final rule.
Cross Representation and Separate Advisory Boards
Comment: Many commenters disagreed with our proposal to require
OPOs to have more than one board and to prohibit individuals from
serving on more than one board, such as both the governing and advisory
boards. These commenters said that our proposal would unnecessarily
force it to revert to multiple boards. Some commenters said they would
have difficulty recruiting an adequate number of qualified individuals
with the required backgrounds and specialties to serve on two boards.
Commenters said that cross membership provides an essential link
between matters considered by both boards. An OPO said that prohibiting
cross representation would inhibit communication and coordination
between boards and would deny both groups access to appropriate
qualified individuals to serve as members. One commenter said that
preventing cross representation could delay decision making because of
the difficulty of communicating between two bodies. Several commenters
recommended that we allow OPOs that have more than one board the
flexibility to decide whether to have cross representation among their
boards.
Response: The PHS Act requires an OPO to have an advisory board
whose members are limited to making recommendations on specific,
delineated activities, and the statute specifically prohibits the board
from having authority over other activities. (See U.S.C. 273(b)(1)(H).)
This limitation was included to ensure that those making
recommendations on the policy issues described in the statute would not
also be in the position of making decisions on other issues, such as
budgeting. Therefore, permitting advisory board members simply to be on
both boards at the same time would subvert the intent of the statute.
Thus, we are retaining the language from our proposed rule.
Comment: One commenter said that CMS should consider adding
language to paragraph (b) that describes the expectation for and duties
of advisory board members, such as the specific subject matters that
may be addressed (but not the standards to be applied or how the
governing board should evaluate their contributions). The commenter
recommended that this paragraph should provide that individuals on the
advisory board should use their expertise to assist the governing body
with its duties and functions.
Response: This final rule includes the PHS Act language we
proposed, which specifies the OPO activities that an OPO's advisory
board is permitted to address. Under the Act, members of the advisory
board have no authority over any other activity of the OPO.
Conflict of Interest
Comment: One commenter said that the proposed rule ignores already-
existing State and Federal laws that address conflicts of interest,
such as state corporate laws. The commenter said that state laws and
common law have clear standards requiring board members to uphold their
fiduciary responsibility to the organization they serve. The commenter
pointed out that Federal law governing tax-exempt organizations also
imposes standards and safeguards.
Response: We acknowledge that there are existing laws requiring
board members to uphold their fiduciary responsibility to the
organizations they serve. However, given the unique nature of an OPO's
business, we believe that OPOs need specific bylaws and procedures to
address potential conflicts of interest for OPO boards and governing
bodies. We believe the most important decisions entrusted to the
members who make decisions for the administration and governing of an
OPO are those that directly affect the OPO's ability to maximize the
recovery of viable organs for transplantation. Thus, we urge OPOs to
adopt conflict of interest policies that are clear and unequivocal in
addressing these matters.
Comment: An OPO commented that it supports the intent of the
proposed rule to mitigate the influence of transplant centers on OPO
operations. However, the OPO said that by adding community-based
members who are not affiliated with the transplant centers and by
enforcing a strong conflict of interest policy, it has developed a
diverse and appropriately involved board of directors. Another OPO
commented favorably on our proposal to address conflict of interest
issues within OPO boards. The OPO said it enforces its conflict of
interest policies to prevent members from asserting their own agendas
in board votes.
Response: We agree that adding board members who are not affiliated
with transplant centers helps to balance transplant center
representation on an OPO's board, and implementing strong conflict of
interest policies can prevent members from asserting their own agendas.
Therefore, although we are making no changes to the regulations text,
we suggest that OPOs consider
[[Page 31011]]
balancing transplant center representation on their boards by adding
community-based members and developing and implementing strong conflict
of interest policies.
Comment: A commenter said that OPOs' conflict of interest policies
should require conflict of interest disclosure statements consistent
with state corporation law and IRS requirements and practices.
Response: We expect that OPOs will follow all pertinent local,
State, and Federal laws that govern conflict of interest, including the
specifics of those laws in regard to conflicts of interest disclosure
statements.
Comment: One commenter recommended that OPO surveyors review board
minutes to ensure that OPOs are complying with the requirement to have
conflict of interest policies.
Response: We will develop Interpretive Guidelines for surveyors
following publication of this final rule. The Guidelines will provide
specific information about how surveys will be conducted under the new
regulations, including how surveyors will determine whether OPOs are in
compliance with the requirement to have conflict of interest policies.
Representation on OPO Boards
Comment: In the preamble to the proposed rule, we asked the public
to comment on whether OPOs should be required to have a certain board
membership beyond that which is already required under the PHS Act, for
example, we asked whether we should require OPOs to include members
representing donor families, chaplains, and research institutions. One
commenter said that OPOs should consider OPO board representation from
other stakeholders, but the commenter did not agree that such
representation should be required. The commenter stated that OPOs
should have the discretion to add stakeholders to advisory boards
consistent with the OPOs needs and priorities. The commenter
acknowledged that constituents such as research facilities, donor
family members, transplant recipients, coroners or medical examiners,
social workers, and chaplains can all add valuable input for an OPO and
bring considerable influence. Several OPOs said that they have added
donor hospitals, non-transplant health professionals, donor family
members, transplant recipients, clergy, minorities, and others to their
board of directors. However, most commenters said that OPOs must have
the flexibility to bring those resources to bear as needed in each
community. One commenter who said we should not require specific board
representation pointed out that Medicare conditions of participation
for hospitals do not have specific requirements for board membership.
However, one commenter recommended that we require OPOs to include
donor families on OPO boards.
Response: We agree with the commenters who stated that the addition
of stakeholders and community representatives to OPO boards provides
OPOs with valuable input and helps to balance the interests of the
transplantation community. We would urge OPOs that do not have such
wide representation to add additional members to their boards. For the
most part, we agree that OPOs should have the flexibility to determine
the knowledge, skills, and background they need for the members who
will serve on their boards and their governing bodies (except, of
course, for the membership required under the PHS Act). However, we
agree with the commenter who recommended that donor family members be
included on OPO boards. OPOs have many ``customers,'' including
transplant centers and tissue banks, but, arguably, the most important
of an OPO's customers is the donor family. Every OPO needs the unique
perspective that a donor family member brings to the table to address
the many issues that relate to the interaction between donor families
and the OPO. These issues range from consent rates to whether family
members are permitted in the operating room prior to a donation after
cardiac death. Therefore, in addition to those representatives required
under the PHS Act, this final rule requires an OPO to have a
representative from an organ donor family on one of its boards.
Comment: One commenter said that our proposal that only a
transplant surgeon (not a transplant physician) can represent a
transplant center on an OPO's board ignores the valuable input that a
transplant physician can provide.
Response: We agree that a transplant physician is likely to be a
useful and effective addition to an OPO board, and we would encourage
all OPOs to consider adding a transplant physician. However, OPOs that
have a large number of transplant hospitals in their service areas and,
therefore, a large number of transplant surgeons on their boards may
find that adding an additional transplant physician is too burdensome.
Therefore, this final rule does not include a requirement for an OPO
board to include a transplant physician.
Tissue Bank Representative
Comment: One commenter said that the PHS Act requirement to include
a tissue bank representative is intended only to ensure that there is a
board member with tissue banking experience. The commenter suggested
that the tissue bank representative could be from a tissue bank outside
the OPO's service area.
Response: We disagree with the commenter. Clearly, the intention of
the PHS Act is that OPOs should include tissue banks from within their
service areas. The Act requires, ``members who represent hospital
administrators, intensive care or emergency room personnel, tissue
banks, and voluntary health associations in the OPO's service area * *
*.'' Thus, we are not accepting the commenter's suggestion to change
the final rule.
Comment: Several commenters said that if the OPO is offering
competitive tissue recovery or banking services, it is inappropriate to
put a competitor on its board. They said that if the OPO is not
offering such services, then it is likely using a tissue bank or
processor as a vendor and it would be just as inappropriate to place a
major vendor on the board because the conflict would be too pervasive.
Commenters also said that vendor relationships can change quickly,
which could leave an ex-vendor on the board as a director. Several
commenters objected to the proposed requirement because they said that
tissue banks are OPOs' competitors. One commenter stated that the
requirement appears to expand the statutory objective to a market
objective of ensuring that the commercial issues of competitive or
vendor tissue banks in the OPO's service area are addressed by the OPO.
The commenter questioned whether CMS should be concerned about tissue
banks since they are not regulated by CMS.
Other commenters suggested that a tissue bank representative would
act as the representative of an outside entity rather than as a
fiduciary of the OPO. Commenters said that an individual from a tissue
bank, by the very nature of the appointment, would appear to have
primary responsibilities back to the tissue bank. Commenters said that
we should be concerned only about whether an OPO is making a good faith
effort to cooperate with the tissue banks in its service area. Other
commenters said that our proposal would create a conflict of interest
situation by expecting one tissue bank representative to represent the
best interests of all the competing tissue banks in the OPO's service
area.
[[Page 31012]]
Response: We understand the commenters' concerns, and acknowledge
that it may not be appropriate for a tissue bank to be privy to or have
the right to vote on an OPO's fiduciary matters. Furthermore, since
tissue banks are often in competition with one another, we agree with
the commenter that it would be difficult for one tissue bank to
represent the interests of every tissue bank in an OPO's service area.
Nevertheless, under this final rule, an OPO still is required to
have tissue bank members on one of its boards, because it is required
by the PHS Act. However, the tissue bank members may be from the OPO's
tissue bank or any other tissue bank of the OPO's choice. It is not
necessary that the tissue bank members represent all tissue banks in
the service area. We have revised our proposed language accordingly.
(See Sec. 486.324(a)(1).)
Governing Body
Comment: Commenters noted that we asked for comments about whether
``legal authority and responsibility for management and provision of
all OPO services should lie with an individual rather than a governing
body.'' The commenters said that this form of governance would be
inconsistent with the requirements of state nonprofit corporation law
and IRS rules for 501c(3) organizations. Commenters also said that
giving a single individual all legal authority and responsibility for
an OPO would have the effect of eviscerating the valuable ``checks and
balances'' provided by a board of directors and that the OPO would be
likely to lose its tax-exempt status. One commenter said that it would
be inappropriate to charge an individual with all OPO functions without
oversight. The commenter said that OPOs should have a chief executive
officer who is charged with day-to-day operations but who remains
subject to board oversight. One commenter stated that OPOs should be
able to select the most efficient and effective form of government and
management because it permits innovation.
Response: We agree with the commenters that OPOs should have
flexibility to structure its business to the greatest extent possible,
consistent with the restrictions in our statutes and regulations.
Therefore, in this final rule, we have finalized our proposed language,
which states that a governing body must have full legal authority and
responsibility for the management and provision of all OPO services and
must develop and oversee implementation of policies and procedures
considered necessary for the effective administration of the OPO,
including fiscal operations, the OPO's quality assessment and
performance improvement (QAPI) program, and services furnished under
contract or arrangement, including agreements for these services. The
governing body must appoint an individual to be responsible for the
day-to-day operation of the OPO. (See Sec. 486.24(e).)
Comment: One commenter questioned the existence of hospital-based
OPOs and said that their elimination should be seriously considered.
The commenter said that because hospitals are under such extreme
financial pressure, hospital-based OPOs might not be given sufficient
resources to maximize donation.
Response: We understand the commenter's concern that an OPO's
mission to maximize organ donation may not be supported sufficiently by
those who make financial decisions for the OPO. However, it is not
within the purview of this regulation to eliminate hospital-based OPOs.
Condition: Human Resources (Proposed Sec. 486.326)
In the February 4, 2005 proposed rule, we proposed that all OPOs
have a sufficient number of qualified staff, including a director, a
medical director, organ procurement coordinators (OPCs), and hospital
development staff, to ensure that they obtain all usable organs from
potential donors. We proposed that the OPO must have sufficient staff
to ensure that the families of potential donors, hospitals, tissue
banks, and individuals and facilities that use organs for research
receive all of the services required by the proposed rule.
We proposed that OPOs ensure that all persons who provide services
and/or supervise services are qualified to provide or supervise those
services. This requirement would include services that were furnished
both under contract or provided through another arrangement. We
proposed that each OPO would be required to develop and implement a
written policy to address conflicts of interest for the OPO's director,
medical director, senior management, and procurement coordinators.
We proposed requiring OPOs to have credentialing records for the
physicians and other practitioners who routinely recover organs in
hospitals that are under contract or have an arrangement with the OPO.
We proposed that an OPO also would be required to ensure that all
physicians and other practitioners who recover organs in hospitals with
which the OPO has agreements are qualified and trained.
We proposed staffing requirements, including sufficient coverage to
assure that both referral calls from hospitals are screened for donor
potential and potential donors are evaluated timely for medical
suitability. We proposed requiring that OPOs have sufficient staff to
provide information and support to potential organ donor families;
request consent for donation; ensure optimal maintenance of the donor,
efficient placement of organs, and adequate oversight of organ
recovery; and conduct QAPI activities, such as death record reviews and
hospital development. We also proposed that OPOs must have sufficient
recovery personnel to ensure that all usable organs are recovered in a
manner that, to the extent possible, preserves them for
transplantation.
We proposed that OPOs must provide their staff with the education,
training, and supervision necessary to furnish required services. At a
minimum, that training was to include performance expectations for
staff, applicable organizational policies and procedures, and QAPI
activities. We proposed that OPOs would be required to evaluate the
performance of their staffs and provide training, as needed, to improve
both individual and overall staff performance and effectiveness.
We proposed that all OPOs must have a medical director who would be
responsible for implementing the OPO's protocol for donor evaluation
and management and organ recovery and placement. We proposed that the
medical director would be responsible for oversight of the clinical
management of potential donors, including providing assistance in
managing a donor case when the surgeon on call is unavailable.
Below we have provided a summary of the public comments we received
on our proposed provisions, along with our responses to the comments.
General Comments
Comment: Commenters expressed concern that the requirements in the
human resources section at Sec. 486.326 were too prescriptive,
especially the staffing requirements. They stated that the requirements
would not allow OPOs to decide upon the staffing arrangements that
would best suit their needs. They were also concerned about the cost
implications of these requirements.
Commenters recommended that instead of our proposed human resources
requirements at Sec. 486.326, we require OPOs merely to develop and
implement a human resources plan and
[[Page 31013]]
policy. Each OPO's practices would be expected to conform to its own
plan and policy. These commenters stated that an OPO's human resources
plan and policy should include staff adequacy, education and training,
supervision, and performance assessment. One commenter pointed out the
Collaborative has already demonstrated that OPOs can be successful with
a variety of staff configurations.
Response: Our intention is not to publish prescriptive staffing
requirements for OPOs. In fact, we believe the staffing requirements in
this final rule will give OPOs the flexibility to decide upon the
staffing configurations that best suit their needs. We require only
that each OPO have sufficient staffing for the activities that we
require OPOs to perform or provide, but we do not require specific
numbers or ratios of staff for these activities. Each OPO is free to
decide how to staff their OPO to best provide the required activities
and services. We believe the human resources requirements will result
in consistency of outcomes among OPOs to ensure that all OPOs provide
required services.
Comment: Some commenters stated that the accountability for an
OPO's success or outcomes should be broader than the OPO itself. They
wanted other entities, especially the donor hospitals and transplant
centers, to share accountability for OPO's performance.
Response: Standards or requirements for donor hospitals and
transplant centers are outside the scope of this regulation. We
acknowledge that the actions of others, including donor hospitals and
transplant centers, can affect an OPO's performance and/or outcomes.
However, we must stress that OPOs are responsible for all requirements
and outcomes in this final regulation. If OPOs encounter problems with
other entities, they should first try to resolve the problem with that
entity. If they cannot, they can seek assistance from the appropriate
CMS Regional OPO Coordinator.
Section 486.326(a) Standard: Qualifications
Comment: Many commenters expressed concern over the requirement at
486.326(a)(3) that each OPO must have credentialing records for
physicians and other practitioners who routinely recover organs in
hospitals that have agreements with the OPO and that the OPO must
ensure that all physicians and other practitioners who recover organs
in hospitals with which the OPO has an agreement are qualified and
trained. Some commenters stated that they agreed that OPOs should
verify physician and surgeon credentials, but asked for clarification
on exactly what would be required.
Response: As we stated in the February 4, 2005 proposed rule, OPOs
would be required ``to have credentialing records for physicians and
other practitioners who routinely recover organs in hospitals under
contract or arrangement with the OPO * * *.'' We are not requiring that
OPOs actually conduct a credentialing process of their own. We expect
OPOs to have records that clearly demonstrate that these practitioners
are credentialed in their own medical or surgical facilities. An OPO
could satisfy this requirement with a letter from the credentialing
facility indicating that a practitioner is credentialed in their
facility and any limitations or conditions that facility has placed
upon the practitioner's practice. An OPO does not need to maintain the
entire credentialing file. However, if the OPO does not have the entire
file or a copy of it, the OPO should have an agreement with the
appropriate facility for access to the entire record should the OPO
have any questions or concerns about a practitioner's qualifications or
training.
Comment: Some commenters supported verification of recovery
personnel's credentials or qualifications and training but did not
believe it should be the OPO's responsibility. Commenters stated that
OPOs should be allowed to rely on a transplant hospital's extensive
credentialing system to determine that recovery surgeons and other
personnel are qualified. They stated that to require OPOs to maintain
credentialing records was duplicative.
Other commenters suggested that we should require transplant
centers to be responsible for verifying physicians' credentials prior
to recovery. A commenter suggested that credentialing be a requirement
in the Hospital Conditions of Participation, especially for recovering
physicians and other practitioners utilized by the OPO on an infrequent
basis and outside the designated service area. Commenters noted that
since the transplant hospital sends the recovery team, the transplant
hospital has both the leverage and the authority to require compliance
with a credentialing process. Commenters said that we should require
the transplant hospital that sends out the recovery team to provide the
OPO with information about the recovery staff's qualifications in
advance of any recovery and respond promptly to OPO requests for
information.
Another commenter said there should be a national standard and
suggested that DHHS ask the OPTN to develop policies for recovery team
qualifications that OPTN members would be required to follow as a
condition of membership in the OPTN.
Response: We disagree with the commenters. We believe that an OPO
should be responsible for ensuring that personnel who recover organs
and tissues in hospitals with which the OPO has agreements are
appropriately credentialed. As we pointed out in the preamble to the
proposed rule, it is difficult, if not impossible, for a donor hospital
to credential and grant privileges to recovery surgeons and other
members of the recovery teams who are not members of the hospital's
medical staff and who may recover organs in a particular donor hospital
no more than once in a period of several years (70 FR 6105). The
recovery personnel's work in the donor hospital is too limited to
undergo effective review by the donor hospital for the granting of
clinical privileges (70 FR 6105).
However, all hospitals, including transplant hospitals, are
responsible for credentialing and granting privileges to medical staff.
Section 482.22 of the Hospital Conditions of Participation requires
that a hospital's medical staff must examine credentials of candidates
for medical staff membership and make recommendations to the governing
body for appointments. Further, the medical staff bylaws must include
criteria for determining the privileges to be granted to individual
practitioners and a procedure for applying the criteria to individuals
requesting privileges.
In this final rule at Sec. 486.344(d), OPOs are required to
collaborate with transplant programs to establish protocols that define
the roles and responsibilities of the OPO and the transplant program
for all activities associated with, among other activities, organ
recovery. We expect that OPOs will use these collaborative agreements
to spell out how they will obtain credentialing information on recovery
personnel. We believe that OPOs should verify that recovery personnel
are credentialed by a transplant hospital or that they are otherwise
qualified and trained as part of the services they provide to donor
hospitals. Therefore, we will finalize Sec. 486.326(a)(3) as proposed.
The suggestion that the OPTN develop policies for recovery team
qualifications is beyond the scope of this final regulation. However,
this suggestion will be forwarded for consideration to the agency that
oversees the contract for the OPTN, the
[[Page 31014]]
Health Resources and Services Administration (HRSA).
Comment: Commenters recommended that the Memorandum of Agreement or
Understanding between a transplant hospital and the OPO should specify
how the credentialing responsibility would be handled between the
transplant hospital and OPO. Other commenters recommended that any
surgical recovery team that is currently provided privileges by one OPO
should received reciprocity from other OPOs.
Response: As we stated in our previous response, Sec. 486.344(d)
requires OPOs to collaborate with transplant programs to establish
protocols that define the roles and responsibilities of the OPO and the
transplant program for all activities associated with organ recovery.
Therefore, we agree with the commenters that the Memorandum of
Agreement or Understanding may provide an opportunity to address how
the credentialing responsibility will be handled. However, we believe
that the OPO and the transplant hospital should have the flexibility to
determine what works best for their situation. Reciprocity is certainly
one method that OPOs can use to ensure the credentialing and/or
qualifications and training of the recovery personnel. However, we
believe that OPOs need the flexibility to decide how to handle this
responsibility.
Comment: Some commenters noted that OPOs should have a way to
verify the credentials of recovery personnel 24 hours a day, especially
for a ``visiting team.''
Response: We agree with the commenters. OPOs operate on a 24-hour-
a-day, 7-day-a-week schedule, 365 days a year. OPOs should maintain
documentation of credentialing and/or qualifications and training for
recovery personnel who routinely recover organs for the OPO. Each OPO
should have a method in place for quickly obtaining verification of the
credentials and/or qualifications and training of recovery personnel
who do not routinely recover organs for the OPO.
Section 486.326(b) Standard: Staffing
Comment: Many commenters agreed that sufficient staffing is an
extremely important consideration for an OPO's successful performance
and that each OPO needs the flexibility to determine what staffing
levels should be. However, there were concerns that CMS was suggesting
specific staffing levels. Commenters noted that CMS indicated in the
February 4, 2005 proposed rule that ``* * * we do not propose to
establish specific staffing levels because OPOs must have the
flexibility to determine their own staffing levels.'' (70 FR 6106).
Yet, commenters said that we provided ``guidance to OPOs so that they
can determine if the number of staff they have would be sufficient.''
(70 FR 6106). One commenter specifically noted one of the examples,
that an ``OPO should look closely at hospital development staffing
because effective hospital development creates a culture that supports
and promotes donation.'' (70 FR 6106). Commenters expressed concern
that requests we made for comments on various ``staff markers'' and the
guidance we provided would eventually lead to a requirement for actual
numbers of staff. Commenters also noted that many successful OPOs have
different staffing patterns.
Response: We agree with the commenters that there is no one
staffing pattern that all OPOs should follow. As we stated in the
February 4, 2005 proposed rule, we are not requiring specific staffing
levels for OPOs because we believe that OPOs need the flexibility to
establish those levels based upon their needs (70 FR 6106). The
guidance provided in the proposed rule was intended only to provide
some direction to OPOs in assessing what staffing levels their own OPO
needs to provide the services and activities required by this
regulation. We would note that we do not prescribe staffing levels for
other Medicare providers or suppliers and have no intention of doing so
for OPOs.
Comment: Commenters were concerned about how CMS was going to
determine what was sufficient or adequate staffing. They were also
concerned about how CMS was going to enforce this requirement.
Response: The determination of whether or not an OPO has adequate
staffing is primarily based upon outcomes (70 FR 6106). We also noted
that outcomes included the ``intermediate steps that lead to the
procurement (such as assessing the potential donor and obtaining
consent), as well as those critical activities that support and
surround the actual donation process (such as hospital development and
death record reviews).'' (70 FR 6106). We would not expect to cite an
OPO for having insufficient staff if the patient outcomes are good. The
requirement is intended to give surveyors the option of citing an OPO
when there is a pattern of consistent understaffing in critical areas,
and the OPO has not taken the appropriate steps to improve the
situation (for example, if the board of directors has refused to
approve funds for additional staff needed to improve the OPO's
performance).
Comment: Commenters expressed concern that the requirements for
sufficient staffing could ultimately be inconsistent or out-of-date
with the ``best practices'' being shared through HRSA's Collaborative.
Commenters noted that the Collaborative has resulted in a rapid
evaluation of staffing models and organizational change in OPOs. As
staffing models are modified as a result of the Collaborative, the
proposed requirements may be ``out of synch'' with what the OPOs are
doing with staffing. One commenter suggested that adequacy of staffing
levels should be an element in an OPO's human resources plan.
Response: As we stated in our previous response, we are not
requiring any specific number of staff to achieve ``sufficient''
staffing levels. We are requiring only that OPOs determine how much
staff they need to achieve the outcomes mandated under this final rule.
This final rule requires OPOs to have sufficient staff to provide the
activities and services required of all OPOs, but we believe the
requirements are flexible enough to accommodate any changes in staffing
models that may be developed in the future.
Comment: Commenters said that in Sec. 486.326(b)(1), we proposed
that OPOs ``provide sufficient coverage * * * to assure * * * that
potential donors are evaluated for medical suitability in a timely
manner.'' This language concerned commenters who said that if OPO staff
made a ``suitability determination,'' it would interfere with the
transplant surgeon's decision whether or not to transplant a particular
organ into a particular patient.
Response: We do not intend to interfere with any transplant
surgeon's decision whether to transplant a particular organ into a
particular patient. However, OPOs are responsible for assessing
potential organ donors to determine whether they meet the initial
medical criteria for organ donation. The proposed language merely
requires that OPOs have sufficient staff coverage to ensure that this
assessment takes place in a timely manner. Therefore, we have revised
the language in Sec. 486.326(b) by adding ``for organ and/or tissue
donation'' after ``medical suitability'' to clarify that this is for
the initial determination of whether or not the potential donor meets
the criteria for organ and/or tissue donation.
Comment: Commenters were also concerned that the ``suitability''
language in the proposed rule discussed above could result in increased
liability for the OPOs. Commenters noted that OPOs have been dismissed
from ``bad organ'' state malpractice cases because
[[Page 31015]]
the OPOs make no determination as to the suitability of organs. They
felt that the language above could result in OPOs no longer having that
defense.
Response: OPOs do not make any determination as to the suitability
of a particular organ for a particular patient. That determination
remains the exclusive prerogative of the transplant surgeon. As
discussed in the previous comment and response, we have revised the
language in Sec. 486.326(b) to clarify that the ``medical
suitability'' determination made by an OPO concerns only whether or not
the potential donor meets the medical criteria for organ and/or tissue
donation.
Comment: One commenter expressed particular concern with the
working conditions of OPO procurement coordinators. The commenter
pointed out that by not mandating a maximum number of working hours,
procurement coordinators will continue to be worked to the ``point of
physical and emotional exhaustion and profound sleep deprivation.'' The
commenter noted that the Federal Government mandates working hours for
several occupations, such as air traffic controllers and truck drivers
and said that a procurement coordinator's work is just as crucial as
other occupations for which the Federal government mandates working
hours. The commenter also wanted CMS to mandate maximum hours before a
rest period and on-call hours for OPCs.
The commenter also said that some OPOs are not hiring a sufficient
number of procurement coordinators, which results in many procurement
coordinators suffering from sleep deprivation due to working very long
hours. The commenter stated that even though some OPOs may claim they
cannot afford to hire more staff, the situation results in increased
turnover of procurement coordinators. As a result, the OPOs must pay
higher wages, they have less cohesive work teams, and their
relationships with their hospitals are impaired.
Response: We too are concerned that some OPOs do not have enough
procurement coordinators to prevent staff burnout and high staff
turnover, and we agree that OPO procurement coordinators and other
staff must have adequate rest and reasonable working hours to perform
their jobs properly. Also, we would expect that high staff turnover
could impair working relationships among OPO staff and between OPO
staff and hospitals. In the February 4, 2005 proposed rule, we provided
guidance to ``OPOs so they can determine if the number of staff they
have would be ``sufficient'' (70 FR 6106). This guidance recommends
looking at the intermediate steps in the donation process, not just the
ultimate outcome. We will not mandate working hours for OPO staff in
this final rule, because we believe each OPO must have the flexibility
to determine its own staffing protocols. However, we expect OPOs to
take whatever steps are necessary to ameliorate their staffing
problems, including the hiring of additional procurement coordinators.
OPOs that do not address consistently inadequate staffing in critical
areas are likely to find that their shortcomings are reflected in their
performance on the outcome measures in this final rule.
Section 486.326(c) Standard: Education, Training, and Performance
Evaluation
Comment: Some commenters urged CMS to require the certification of
procurement coordinators through the American Board of Transplant
Certification (ABTC). They pointed out that certification ensures that
the evaluation of potential donors, medical management of donors,
retrieval arrangements, and family consultation are performed with the
highest standards accepted within the transplant community.
Response: There is no evidence available at this time that
indicates that certification increases the quality of services
provided. While it is likely that certification guarantees a certain
level of competence, many OPOs have highly competent, successful
procurement coordinators who are not certified. Therefore, we believe
that to impose a certification requirement for procurement coordinators
may be unduly burdensome. Furthermore, this final rule at Sec.
486.326(c), requires OPOs to ensure that their staff get the necessary
education and training to perform their required responsibilities. One
way for an OPO to satisfy this requirement in regard to procurement
coordinators would be to assist them in obtaining certification, but
this final rule does not require procurement coordinators to be
certified. Therefore, we have made no changes to our proposed language.
Comment: Commenters urged us to be less prescriptive in our human
resources requirements, including the requirements for competency
through industry training.
Response: We disagree that our requirements for education,
training, and performance evaluation are too prescriptive. This
standard requires an OPO to provide its staff with the education,
training, and supervision necessary to furnish required services.
Training must include, but is not limited to, performance expectations
for staff, applicable organizational policies and procedures, and QAPI
activities. OPOs must evaluate the performance of their staffs and
provide training, as needed, to improve individual and overall staff
performance and effectiveness. We are not requiring OPOs to conduct the
required training, education, or performance evaluation in any specific
manner or use a particular method. We believe that these are reasonable
requirements and that they provide the OPOs with sufficient flexibility
to develop and implement training programs, policies, and procedures
that will suit their particular needs.
Comment: One commenter expressed approval for the requirement for
OPOs to conduct training. However, the commenter recommended that we
establish a national standard for training. Conversely, one commenter
said that while each staff member should have an appropriate
orientation to his or her job, we should not mandate that staff handle
a particular number of donation cases during an orientation or that an
orientation should last for a specified amount of time. The commenter
stated that such a requirement could result in OPOs providing only that
amount of training without allowing for the individual staff member's
needs.
Response: We disagree with the commenter. We do not believe that we
should either endorse or require a particular type or length of
training for all OPOs beyond the minimum requirements established in
this final rule at Sec. 486.326(c). Each OPO should have the ability
to develop training programs tailored to its own particular
circumstances, policies, and activities.
Thus, the requirements in this final rule provide flexibility for
OPOs to evaluate their staff and provide the training necessary to meet
the needs of individual staff members.
Section 486.326(d) Standard: Medical Director
Comment: One commenter stated that the requirement for OPOs to have
a medical director was overly prescriptive.
Response: We disagree. As we stated in the February 4, 2005
proposed rule, ``Although current regulations do not require OPOs to
have a medical director, most if not all OPOs employ a medical director
as part of their management staff and recognize the value and expertise
this position brings to their OPO programs.'' (70 FR 6108). We also
noted that ``We believe that nearly all OPOs have a full-time or one or
more
[[Page 31016]]
part-time directors * * *.'' (70 FR 6124).
In addition, the OPTN's bylaws for their members state that all
OPOs must have a medical director. Under this final rule, we are
requiring OPOs to be members of and participate in the OPTN. Thus,
rather than being overly prescriptive, a requirement that OPOs have a
medical director reflects the current practice in the industry.
Comment: In addition to requiring that OPOs have a medical
director, some commenters wanted us to impose additional conditions on
this position. One commenter wanted us to include a requirement for a
medical director to be a ``licensed physician'' and to define
``licensed physician'' as a physician licensed in the United States to
prevent physicians licensed outside the United States from becoming OPO
medical directors.
Response: We agree with the commenter. In fact, Sec. 1861(r)(1) of
the Act defines ``physician'' for the Medicare program as ``a doctor of
medicine or osteopathy legally authorized to practice medicine and
surgery by the State in which he performs such function or action * *
*.'' We expect each OPO to hire a medical director who is able to
fulfill all the functions required under this final rule and under the
laws of the State(s) or territory in which the OPO operates. Since the
OPO medical director is responsible for overseeing the clinical
management of potential donors and providing assistance in managing
donor cases when the surgeon on call is unavailable, the OPO medical
director should be a physician licensed in at least one of the States
within the OPO's service area or as required by state law. Thus, we are
revising the first sentence in Sec. 486.326(d) to read, ``(d)
Standard: Medical Director. The OPO's medical director is a physician
licensed in at least one of the States or territory within the OPO's
service area or as required by State or territory law.'' The medical
director is responsible for * * *.''
Comment: Some commenters stated that medical directors should be
physicians with specific expertise or experience. Some commenters
recommended that medical directors have experience in organ donor
intensive care medical management or organ transplantation. Another
commenter simply stated that the medical director should have the
knowledge and experience to support the OPO.
Response: Once again, we believe that flexibility is the key. In
this final rule, we have attempted to avoid overly prescriptive
requirements that would force OPOs to make changes in successful OPO
staffing arrangements or OPO functioning. We believe that requiring an
OPO to have a medical director is sufficient. Although we expect that
most OPOs want and need medical directors who have relevant expertise
and experience, we do not believe that we should establish minimum
qualifications for a medical director, beyond requiring that the
medical director be a physician licensed in at least one of the States
within the OPO's service area or as required by State or territory law.
Comment: Commenters expressed concern that having a medical
director involved in donor evaluation could interfere with the
transplant surgeon's decision on whether to transplant a particular
organ or tissue into a particular patient. Commenters stated that
transplant surgeons or physicians should make the ultimate decision on
transplantation. When these commenters were discussing the role of
medical directors, they also added that the organ offers and placement
by the OPO staff should be made in accordance with United Network for
Organ Sharing (UNOS) allocation policies.
Response: As stated in our earlier response, the suitability
determination made by OPO staff, including the medical director,
concerns only a potential donor's medical suitability for organ and/or
tissue donation. OPOs are not required by this final rule to make any
determination as to the suitability of a particular organ for a
particular patient. That determination remains the exclusive
prerogative of the transplant surgeon.
Comment: Commenters requested that the role of the medical director
be clarified, especially regarding the expected level of medical
oversight and involvement. Commenters stated that medical directors
should provide medical consultation on specific cases when needed but
should not be required to evaluate each case. Commenters were very
concerned that requiring the medical director to be involved in day-to-
day operations in the clinical management of donors would be very
onerous and would vary greatly among the OPOs. Commenters said that the
medical director's role should be to guide the development of donor
management policies.
Response: In Sec. 486.344 of the February 4, 2005 proposed rule,
we proposed requiring that the OPO medical director would be
responsible for ensuring that donor evaluation and management protocols
are implemented correctly and appropriately to ensure that every
potential donor is thoroughly assessed for medical suitability for
organ and/or tissue donation and clinically managed to optimize organ
viability and function. We also proposed that an OPO must implement a
system that ensures the medical director or other qualified physician
is available to assist in the medical management of a donor when the
surgeon on call is unavailable.
The level of oversight provided by a medical director will vary
from case to case. We are not requiring that the medical director
either evaluate every potential donor or be involved in the management
of every donor case. While the medical director is responsible for
overall implementation of the protocols, we expect that in most cases,
he or she will delegate the responsibility for direct implementation of
the protocols to other staff. We agree with the commenters who said
that medical directors should provide medical consultation on specific
cases when needed but should not be required to evaluate each case. We
also expect that a medical director will provide assistance in the
clinical management of donation cases when needed.
Condition: Reporting of Data (Proposed Sec. 486.328)
The February 4, 2005 proposed rule we stated that we would require
OPOs to provide individually-identifiable, hospital-specific organ
donation and transplantation data to the OPTN and the SRTR, as directed
by the Secretary. In addition, we proposed requiring OPOs to provide
hospital-specific organ donation data to transplant hospitals annually.
We also proposed requiring OPOs to report individually-identifiable,
hospital-specific organ donation and transplantation data and other
information to us, as requested by the Secretary.
We proposed that the data would include, but not be limited to,
number of hospital deaths; results of death record reviews; number and
timeliness of referral calls from hospitals; potential donor
denominator; data related to non-recovery of organs; data about
consents for donation; number of donors; number of organs recovered (by
type of organ); and number of organs transplanted (by type of organ).
We also proposed that the potential donor denominator data reported to
the OPTN to be used for OPO re-certification must include data for all
deaths that occurred in hospitals and critical access hospitals in the
OPO's service area, unless a hospital or critical access hospital was
granted a waiver to work with a different OPO. We proposed requiring
OPOs to report data to the OPTN within 30 days after
[[Page 31017]]
the end of the month in which a death occurred. We proposed that if an
OPO determined through death record review or other means that the
potential donor denominator data it reported to the OPTN was incorrect,
it would be required to report the corrected data to the OPTN within 30
days of the end of the month in which the mistake was identified. We
proposed specific definitions for determining the information to be
collected, such as how a split liver would be counted. Finally, we
proposed requiring an OPO to report organ donation data to hospitals
annually.
Based on public comments, we are not finalizing our proposal to
require OPOs to report hospital organ donation data to the public
annually because those data are readily available on the SRTR Web site,
http://www.ustransplant.org. We have made minor changes to our proposed
data reporting requirements to incorporate the definitions of
``eligible deaths'' and ``eligible donors.''
We have provided a summary of the comments we received on our
proposed section and our responses are discussed below:
Comment: A few commenters asked for clarification about which data
would need to be ``individually identifiable.'' One commenter stated
that OPOs currently report individually-identifiable data on actual
organ donors to the OPTN, but the data reported on eligible deaths is
aggregated by hospital. Commenters pointed out that reporting
individually-identifiable data on eligible deaths would add a
significant reporting burden.
Response: Currently, OPOs report the data on eligible deaths to the
OPTN as aggregated by hospitals. However, for all individuals who
become organ donors for the purpose of transplantation or research, the
OPOs do report individually-identifiable health information to the
OPTN.
The type of data and how it is reported to the OPTN is governed by
the OPTN. We are not asking for individually-identifiable health
information to be reported directly to us.
Comment: One commenter took exception to the proposed requirement
to report an error in data reporting ``within 30 days of the end of the
month in which the mistake is identified.'' The commenter said that
because we proposed no required time frame for conducting death record
reviews, it could be a year or more before a mistake was identified and
reported.
Response: We agree that data reporting errors must be corrected
promptly because the data will be used for certification purposes in
the future and both OPOs and hospitals need reliable eligible donor and
eligible death data to inform their decision making and their quality
improvement programs. We have decided to retain the language in
proposed Sec. 486.328(b) concerning an OPO reporting data and
corrected data to the OPTN. In the final rule, this language has been
moved to Sec. 486.328(d). We are retaining this language due to a
change we have made in the requirement for death record reviews. In
Sec. 486.348(b), we are now requiring OPOs to conduct death record
reviews at least monthly in every Medicare and Medicaid participating
hospital with a Level I or Level II trauma center or with 150 or more
beds and a ventilator and an intensive care unit (ICU). The only
exceptions are hospitals that have a waiver to work with another OPO
and psychiatric and rehabilitation hospitals. This requirement will
provide OPOs with timely data so that they can inform the OPTN of data
reporting errors promptly.
Comment: Commenters protested our proposed requirement for OPOs to
report hospital organ donation data to the public annually. They
pointed out that the SRTR publishes on its website extensive hospital
organ donation data, which is updated twice each year.
Response: We agree with the commenters. At the time we developed
the OPO proposed rule, the SRTR did not publish hospital organ donation
data. Now that it is readily available to the public, we see no need to
burden OPOs with this requirement. However, we would urge OPOs to
inform their hospitals where to access the data and to provide the data
directly to hospitals that request it.
Comment: Many commenters voiced apprehension that data on organ
donor potential would not be reported correctly. They said that the
outcome measures would not be fair to all OPOs if some OPOs under
reported their donor potential.
Response: Because organ donor potential (now termed ``eligible
deaths'') forms the basis for one of the outcome measures in this final
rule, accurate reporting of data is critically important. We would
strongly emphasize that OPOs must adhere meticulously to the definition
of ``eligible deaths'' when reporting data to the OPTN. Whereas we
acknowledge there is some potential for inaccurate reporting, as we
stated earlier in this preamble in our discussion of the outcome
measures, the SRTR statistical methodology will act as a ``check'' on
the eligible donor and eligible death data OPOs report to the OPTN. In
addition, CMS Regional OPO Coordinators will be working with the OPOs
and are available to provide guidance to the OPOs. We will also work
with HRSA to determine whether a procedure can be established to assist
OPOs that have a questionable case.
Condition: Information Management (Proposed Sec. 486.330)
In the February 4, 2005 proposed rule, we proposed that OPOs must
establish and use an information management system to maintain the
required medical, social and identifying information for every donor
and transplant recipient and develop and follow procedures to ensure
the confidentiality and security of the information. We proposed
specific information that must be maintained in the record for every
donor. We proposed that an OPO must also maintain records showing the
disposition of each organ that is recovered for the purpose of
transplantation, including information identifying the transplant
recipient. We proposed requiring OPOs to maintain donor and recipient
records for 7 years in a format readable by humans and reproducible in
a paper or electronic format. In addition, in the event that a
successor OPO takes over an OPO's donation service area, we proposed
that an OPO must maintain the data in a format that can be readily
transferred to a successor OPO and must be able to provide copies to
CMS of all records. We proposed that the records and data subject to
this requirement would include donor and transplant recipient records
and procedural manuals and other materials used in conducting OPO
operations.
Comment: One commenter recommended that we insert ``electronic''
before ``information management system'' at the beginning of this
provision. The commenter said that donor information needs to be
maintained in an electronic format so that the data can be communicated
to Federal agencies and contractors, as well as to ensure that the
information can be transferred easily to a successor OPO. The commenter
also noted that each OPO should specify in its agreements with
hospitals the method of electronic access that will be used so that
information can be communicated during the donation process to its own
data systems, the OPTN, and any other organization to which the OPO
grants access.
Response: We agree with the commenter that in today's health care
environment, information management systems must be electronic. In
fact, the Department released a health
[[Page 31018]]
information technology plan in 2004 that was ordered by President Bush
and prepared by the National Coordinator for Health Information
Technology, David J. Brailer, M.D. The 10-year plan would transform the
delivery of health care by building a new health information
infrastructure, including electronic health records and a new network
to link health records nationwide. At the time, then Secretary Tommy
Thompson said, ``America needs to move much faster to adopt information
technology in our health care system * * *. We can't wait any longer.''
It is our understanding that all of the OPOs already have
electronic information management systems to manage the immense amount
of information they must maintain. Thus, we will add ``electronic''
before ``information management system'' to the Sec. 486.330
introductory text.
We also agree that it would be a good business practice for an OPO
to include information about electronic access in their agreements with
hospitals, but we do not believe it is necessary to include such a
requirement in this final rule. We believe OPOs should be free to work
out the logistics of electronic access with their individual hospitals.
Comment: A commenter recommended that we add a new subsection to
Sec. 486.330 to address data confidentiality and security. The
commenter said that the subsection should require OPOs to adhere to
federally-published data confidentiality and security standards and
follow security and confidentiality requirements established by the
OPTN. The commenter added that in maintaining data within its physical
control, the OPO should consider and include patient data
confidentiality measures outlined by the National Institute of
Standards and Technology and required by the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), to protect the
identities of potential donors, donors, donor next-of-kin, transplant
candidates, and transplant recipients.
Response: We agree that OPOs must ensure the confidentiality and
security of the information they acquire and maintain. However, Sec.
486.330 already requires that OPOs ``must establish and use an
information management system to maintain the required medical, social
and identifying information for every donor and transplant recipient
and develop and follow procedures to ensure the confidentiality and
security of the information.'' We believe that this language is
sufficient and that the new section proposed by the commenter is
unnecessary. We expect OPOs to adhere to all applicable Federal, State,
and local requirements to ensure the confidentiality and security of
the information they maintain.
Comment: A commenter recommended that we insert a new subsection
addressing technology standards. The commenter recommended that the
subsection should require OPOs to maintain basic technology standards,
as published by CMS and the OPTN, to provide for donation information
access, communication, storage, redundancy, privacy and security.
Response: We appreciate the comment. However, we believe the
proposed requirements, which we have finalized in this rule, are
sufficient to ensure that OPOs maintain basic technology standards to
provide for information access, communication, storage, redundancy,
privacy and security.
Comment: One commenter objected to OPOs having to maintain donor
records related to tissue and eye donation when the OPO is not a tissue
or eye recovery agency.
Response: We proposed this requirement at the request of the Food
and Drug Administration and the Centers for Disease Control and
Prevention so that Federal and State authorities can access both organ
and tissue donor information from one central point when they
investigate any potential transmission of infectious disease from
donated organs or tissues. The requirement does not apply to all
recovered tissue. It applies only when tissue is recovered in addition
to organs. Whether or not the OPO provides tissue and eye recovery
services, the OPO is still in the best position to maintain these
records. Thus, the section concerning data retention requirements will
be finalized as proposed.
Comment: One commenter submitted a sample of a form developed to
provide documentation of the donor and recipients data.
Response: We appreciate the commenter's submission of the proposed
form. However, CMS is not the appropriate agency to review the
submitted form. Therefore, we have forwarded the form to HRSA for the
OPTN's review.
Comment: Commenters recommended that we request public comment
regarding additional requirements for hospitals under the CMS
conditions of participation for hospitals. Commenters recommended
requirements for hospitals to: (1) Ensure that OPOs have access to key
physicians and other health care professionals; (2) have provisions for
neurologists or other qualified medical professionals to adopt brain
death declaration criteria consistent with state law; (3) notify OPOs
prior to the withdrawal of life support to a patient; (4) if the
hospital has more than 100 beds, identify an advocate for organ and
tissue donation from within the hospital clinical staff; and (5)
establish policies and procedures in conjunction with the OPO to manage
and maximize organ retrieval from donors without a heartbeat.
Commenters also said that if a patient is a potential donor, the OPO
should reimburse the hospital for appropriate costs related to
maintaining that patient as a potential donor.
Response: Although these recommendations for hospital conditions of
participation are beyond the scope of this final regulation for OPOs,
we will consider integrating them into a future regulation for the
hospital conditions for participation.
Condition: Requesting Consent (Proposed Sec. 486.342)
In the February 5, 2005 proposed rule, we proposed that OPOs must
encourage discretion and sensitivity with respect to the circumstances,
views, and beliefs of potential donor families. We also proposed
requiring that OPOs have a written protocol to ensure that the
individual(s) responsible for making the donation decision are informed
of their options to donate organs and tissues (when the OPO is also
requesting consent for tissue donation) or to decline to donate. We
proposed several items of information that OPOs would be required to
provide in requesting consent. The specific items we proposed were: A
list of the organs or tissues that may be recovered; all possible uses
for the donated organs or tissues; information that the individual(s)
have the right to limit or restrict use of the organs or tissues; a
description of the screening and recovery processes; the information
(such as for-profit or non-profit status) about the organizations that
will recover, process, and distribute the tissue; information regarding
access to and release of the donor's medical records; an explanation of
the impact the donation process will have on burial arrangements and
the appearance of the donor's body; information about the procedure for
filing a complaint; contact information in case the individual(s)
making the donation decision have questions; and a copy of the signed
consent form, if the donation is made. In addition, we proposed that if
the OPO does not request consent because the donor previously completed
a donor document that satisfies applicable state
[[Page 31019]]
law, the OPO would be required to provide information to the donor's
family upon their request.
Comment: Some commenters believed the provision was overly
prescriptive and too detailed concerning the minimum amount and types
of information that are required for informed consent. However, other
commenters endorsed the principles expressed in the requesting consent
requirements and said that the provision reflected current practices in
the industry.
Response: In general, we disagree with the commenters who stated
that the provision is overly prescriptive and too detailed concerning
the amount and types of information that is required for informed
consent. Donor families need a certain amount of information upon which
to base their donation decision. We believe there must be a minimum
standard to assure that when families provide consent, they are
providing informed consent. However, after analyzing the comments we
received on some specific proposed items of required information, we
have changed or eliminated some of the requirements. These items are
discussed below in the following comments and responses.
Comment: Some commenters stated that the requirements for
requesting consent are unnecessary. They noted that each State's
anatomical gift law has requirements for informed consent and that the
applicable state law should determine the standard for each OPO.
Response: We disagree with the commenters. We are not aware of any
State anatomical gift legislation that has detailed requirements for
information that must be provided to potential donor families to ensure
informed consent. We believe there must be a minimum standard that will
apply to all of the OPOs and ensure that when an OPO requests consent,
potential donor families receive the information they need to make an
informed decision about donation.
Comment: One commenter provided the following alternative language
for Sec. 486.342(a): ``* * *. The OPO must provide adequate
information to the individual(s) responsible for making the donation,
which may include the following if appropriate and if sensitive to the
individual(s) circumstances, views, and beliefs * * * .''
Response: The commenter has provided very subjective language that
does not appear to establish any minimum requirements. Section 486.342
in this final rule states, ``An OPO must encourage discretion and
sensitivity with respect to the circumstances, views, and beliefs of
potential donor families.'' We believe that OPOs can tailor the
informed consent requirement in this final rule, so that it can be
conveyed in a sensitive and appropriate manner based upon the
circumstances of each potential donor family's situation. Thus, we are
not adopting the commenter's suggested language.
Comment: Some commenters noted that the language requiring
``information about the procedure for filing a complaint'' could be
problematic. A commenter pointed out that to their knowledge ``the
doctrine of informed consent has never included a procedural component
for filing a complaint.'' The commenter noted that adding information
about a complaint process could adversely affect an OPOs' efforts to
obtain consent for donation and said that ``introducing an unnecessary
element, particularly one that suggests subsequent failure,
unhappiness, or change of mind, will likely undercut the consent
success rate that OPOs are struggling so hard to improve.'' The
commenter said that their experience has shown that parties who are
unhappy about something that occurred during the donation process have
not had any difficulty with locating the OPO to discuss their concerns.
Response: We believe the commenters have a good point. OPOs
approach potential donor families during an extremely sensitive time:
the death or imminent death of a loved one. It is important that the
decision maker(s) for organ and/or tissue donation receive all the
information they need for informed consent; however, there is no reason
to introduce unnecessary information that may adversely affect the
donation decision. Therefore, we have removed the proposed
486.342(a)(8) and revised the proposed Sec. 486.342(a)(9). Thus, in
the final rule Sec. 486.342(a)(7) reads, ``Contact information for
individuals with questions or concerns.''
Comment: Some commenters felt that the requirement for informed
consent to include ``All possible uses for the donated organs or
tissues'' was unreasonable and overly burdensome. One commenter
questioned to what degree the OPO had to go to satisfy this
requirement. The commenter asked the following questions:
Does every research project have to be disclosed?
Does every type of therapeutic surgical procedure for
which donated gifts can be used have to be disclosed to the family?
One commenter noted that the typical standard under State law is
whatever a ``reasonable person'' would want to know. Another commenter
felt that complying with this provision could result in the consent
process being lengthy, time consuming, and too graphic to be
appropriate considering the sensitive nature of the consent process and
the need for compassion for the potential donor family. One commenter
recommended that we simply remove the word ``all'' from (a)(2).
Response: We agree with the commenters that informing families of
potential donors and other decision makers of all possible uses for the
donated organs and tissues may be more information than they need or
want to know. However, the decision makers should be informed in
general terms of the ``most likely'' uses of the organs and/or tissues
they are being asked to donate. We believe this can be done without
going into the detail that the above questions posed by the commenter
suggest. For example, we believe most families would be satisfied with
knowing that the organs and/or tissue might be used for research
without wanting to know the specific research projects or that tissue
might be used for therapeutic surgeries without wanting to know the
specific types of surgeries. However, if a family requests additional
or more detailed information, we would expect the OPO to provide that
information. We believe that OPOs need the flexibility to determine
what is appropriate to disclose concerning the most likely uses of
donated organs and tissue and that they can tailor this information so
that it is presented in a sensitive and appropriate manner.
Thus, in Sec. 486.342(a)(2) we are deleting the words ``all
possible'' before ``uses'' and inserting the words ``the most likely''
before ``uses.'' The revised Sec. 486.342(a)(2) reads as follows:
``The most likely uses for the donated organs or tissues.''
Comment: One commenter stated that the requirement to describe the
screening and recovery processes, as well as give information about all
of the potential organizations that may be involved in the recovery,
process, and distribution of tissues could generate a substantial
amount of paperwork. And, rather than being helpful and informative, it
could actually be more confusing and distracting to the potential donor
family or perhaps too graphic.
Response: We disagree with the commenter that any of these
requirements would generate a substantial amount of paperwork. Once an
OPO has developed a standard consent form, the OPO's staff needs to
explain only the applicable sections to the donor family during the
consent
[[Page 31020]]
process. We believe OPOs can explain the screening and recovery process
to potential donor families and decision makers in a manner that is not
too graphic, confusing, or upsetting to the potential donor family.
Comment: A large number of commenters objected to the parenthetical
language in Sec. 486.342(a)(5), ``Information (such as for-profit or
non-profit status) about organizations that will recover, process, and
distribute the tissue.'' While a few commenters felt that disclosing
the profit status of tissue banks involved in the donation process
conformed to the tissue banking industry's standards, others did not.
Some commenters noted that informed consent guidelines developed by the
Association of Organ Procurement Organizations, the American
Association of Tissue Banks, and the Eye Bank Association of America,
the Model Elements of Informed Consent for Organ and Tissue Donation
(adopted November 30, 2000) (Model Elements of Informed Consent),
indicate that disclosing whether businesses involved in the donation
process are non-profit or for-profit should be viewed as an additional
or supplemental element rather than included in minimum requirements
for informed consent.
Some commenters felt that the requirement would be contrary to the
statute, saying that the OPO Certification Act of 2000 mandates that
process performance measures must be based on empirical evidence
obtained through reasonable efforts of organ donor potential and other
related factors in each service area of qualified organ procurement
organizations. These commenters stated that the proposed requirement
had the potential to impede efforts to increase organ donation.
Although some commenters suggested specific language that could be
used to inform families about the profit status of tissue banks, other
commenters stated that disclosing profit status is not relevant or
meaningful information for the donor family. Some commenters pointed
out that the organizations involved in the tissue donation process
(tissue banks) are inherently a mixture of both for-profit and non-
profit entities. Further, commenters said that there is no realistic
way to assure a potential donor family that a for-profit entity will
not at some point be involved in handling the tissue they donate.
Most commenters' chief concern was that informing potential donor
families that for-profit entities will be involved in the tissue
donation process could result in fewer families consenting to tissue
and even organ donation or to decision makers restricting their
donation to non-profit tissue banks. Commenters pointed out that many
people have misconceptions about for-profit tissue banks. One commenter
pointed out that technological advances in tissue donation generally
are made by for-profit, not non-profit, tissue banks. Commenters also
noted that there was a common misconception that non-profits are more
altruistic and more deserving of the donation. However, other
commenters stated that it was important to explain the differences
between for-profit and non-profit tissue banks so that families can
appreciate the important contributions of both.
Response: Based upon these comments, we believe that requiring OPOs
to disclose that for-profit entities will be involved in recovering,
processing, and distributing tissue is not necessary. Both for-profit
and non-profit tissue banks contribute significantly to the tissue
industry and to the benefits that patients receive from donated tissue.
However, explaining the nuances of for-profit and non-profit tissue
banking to the families of potential donors being asked to consent to
organ and/or tissue donation simply is not feasible.
We believe the most appropriate course of action is to allow each
OPO to determine independently what information it needs to disclose
about the various organizations that will be involved in the donation
process. Thus, we have not finalized a requirement for OPOs to disclose
the profit status of tissue banks to families of potential donors and
other decision makers.
In addition, in reviewing the Model Elements of Informed Consent,
we noted that neither the basic elements nor the additional elements of
informed consent contain any requirement to inform decision makers
about the right to limit or restrict the use of organs and/or tissue.
As noted above, we believe there should be a minimum standard for
informed consent. However, there is no reason to introduce unnecessary
information that may adversely affect the donation decision. The
disclosure of the decision maker's right to limit or restrict the use
of organs and/or tissue could result in unreasonable or unnecessary
limitations on donated organs and tissue. Since this could have an
adverse effect on organ and/or tissue donation and availability, this
requirement has been removed from the final rule. We believe it should
be up to each individual OPO if and how the right to limit or restrict
the use of donated organs and/or tissue should be handled.
Evaluation and Management of Potential Donors and Organ Placement and
Recovery (Proposed Sec. 486.344)
We proposed that an OPO must have written protocols for donor
evaluation and management and organ placement and recovery that meet
current standards of practice and are designed to maximize organ
quality and optimize the number of donors and the number of organs
recovered and transplanted per donor.
We also proposed that an OPO's medical director must be responsible
for ensuring that donor evaluation and management protocols are
implemented correctly and appropriately to ensure that every potential
donor is thoroughly assessed for medical suitability for organ donation
and clinically managed to optimize organ viability and function. We
proposed that an OPO must implement a system that ensures that the
medical director or other qualified physician is available to assist in
the medical management of a donor when the surgeon on call is
unavailable.
We proposed that to evaluate a potential donor, an OPO must: Verify
that death has been pronounced according to applicable local, State,
and Federal laws pertaining to organ donation; determine whether there
are conditions that may contraindicate donation; if possible, obtain
the potential donor's medical and social history; review the potential
donor's medical chart and perform a physical examination of the donor;
and obtain the donor's vital signs and perform all pertinent tests.
We proposed that the OPO must: Arrange for screening and testing of
the donor for infectious disease according to current standards of
practice, including testing for the human immunodeficiency virus (HIV);
ensure that screening and testing of the donor (including point-of-care
testing and blood typing) are conducted by a laboratory that is
certified in the appropriate specialty or subspecialty of service in
accordance with the Clinical Laboratory Improvement Amendments (CLIA)
regulations; ensure that the donor's blood is typed using two separate
blood samples; and document the donor's record with all test results,
including blood type, before organ recovery.
We also proposed requiring OPOs to collaborate with transplant
programs by establishing protocols that define the roles and
responsibilities of the OPO and the transplant program for all
activities associated with donor evaluation, donor management, organ
recovery, and organ placement. We
[[Page 31021]]
proposed that the protocol for organ placement must include procedures
to ensure that the blood type of the donor is compared with the blood
type of the intended recipient by two OPO staff members before organ
recovery takes place and that documentation of the donor's blood type
must accompany the organ to the hospital where the transplant will take
place. Further, we proposed that the protocols must be reviewed
periodically with the transplant programs to incorporate best practices
in the field and maximize organ donation.
We proposed a requirement for OPOs for documentation of recipient
information. We proposed that prior to recovery of an organ for
transplantation, an OPO must have written documentation from the OPTN
showing, at a minimum, the intended recipient's position on the waiting
list in relation to other suitable candidates and the recipient's OPTN
identification number and blood type.
We also proposed that an OPO must have a system to allocate donated
organs among transplant patients that is consistent with the rules and
requirements of the OPTN, as defined in Sec. 486.320. Finally, we
proposed that an OPO must develop and implement a protocol to maximize
placement of organs for transplantation.
Comment: Some commenters objected to our proposal that the medical
director would be responsible for ensuring that donor evaluation and
management protocols are implemented correctly and appropriately to
ensure that every potential donor is thoroughly assessed for medical
suitability for organ donation and clinically managed to optimize organ
viability and function. Commenters pointed out that some medical
directors are transplant surgeons who may have expertise only in their
own specialty. Commenters said that such medical directors might rule
out a case before all options have been exhausted and that leaving the
rule-in/out decision to one individual may do a disservice to the goal
of maximizing organ utilization.
Response: We believe the commenters may have misunderstood our
proposed language. We were not proposing to require that the OPO
medical director be directly responsible for determining medical
suitability for every potential organ donor. Rather we proposed (and
are finalizing) language at Sec. 486.344(a) to require the medical
director to be responsible for ensuring that the OPO's protocols for
evaluating and managing potential donors are implemented correctly.
To accomplish this, we expect that a medical director will: Fulfill
his or her own responsibilities under the OPO's protocols for donor
evaluation and management; review organ donation cases periodically or
in real time to determine whether the OPO's protocols were followed
correctly (both in regard to the evaluation of potential donors and the
clinical management of potential donors to ``optimize organ viability
and function'') and, as needed, work with the OPO procurement
coordinators and other OPO staff to improve the protocols, as well as
implementation of the protocols.
Comment: A few commenters viewed our proposal to make the OPO
medical director responsible for implementation of protocols for donor
evaluation and management as inappropriately interfering in the
transplant surgeon's judgment and relationship with his or her patient.
One commenter said that our requirement would interfere with the
transplant surgeon's/physician's decision whether to accept a
particular organ for transplant into a particular patient.
Response: Under our proposal, a protocol for donor evaluation would
include only the evaluation activities necessary to determine whether a
patient is medically suitable for organ donation, such as reading the
patient's chart, examining the patient, and ordering or performing any
necessary lab work or other testing. The protocol would not cover
evaluation of an individual organ's suitability for transplantation
into a specific patient, which is the purview of the individual
patient's transplant surgeon. We have changed the title of Sec.
486.344 and Sec. 486.344(b) and other wording throughout the
regulatory text to clarify that the required protocols are for
evaluation and management of potential donors.
Comment: Commenters said that OPOs should be able to decide who
should provide assistance in clinical management of donors. Several
commenters said that the OPO medical director may not always be the
best physician to assist with donor management challenges faced in the
field. Commenters said that a hospital's critical care intensivist
physicians may be in a better position to look objectively at the donor
picture and provide management expertise. However, the commenter also
stated that some OPOs have highly trained clinical experts who function
in the role of donor management consultants on a case-by-case basis
within their OPOs and these OPOs have very high organs-per-donor
yields. The commenter said that other OPOs may consult with the
intensivist groups at individual hospitals on a case-by-case basis to
receive input on management and that these OPOs also have high organs
per donor yields.
Response: We agree with the commenters that the OPO medical
director may not always be the best individual to consult on issues of
donor management. We proposed that ``an OPO must implement a system to
ensure that the medical director or other qualified physician is
available to assist in the medical management of a donor when the
surgeon on call is unavailable.'' Our intention was simply to ensure
that assistance in managing a potential donor would be available to the
OPO's procurement coordinator if the surgeon on call was unavailable.
However, OPOs clearly have the expertise to determine whether the
medical director, a critical care intensivist physician, or another
clinical expert is the best person to assist a procurement coordinator
in medically managing a potential donor. Many OPOs with high organs-
per-donor outcomes utilize the services of a non-physician clinical
expert. Therefore, in Sec. 486.344(a)(2) we are removing the word
``physician'' after the words ``or other qualified'' and inserting
``individual. The language in this final rule provides OPOs with the
flexibility to determine who will assist in medically managing
potential donor cases. To provide OPOs with the highest degree of
latitude possible, we will not define ``clinical expert'' or ``other
qualified individual.'' Instead, under this final rule we require an
OPO, in their policies and procedures, to define who is considered a
``qualified individual'' based on current standards of practice and
implement a system that ensures that a qualified physician or other
qualified individual is available to assist in the medical management
of a donor when the surgeon on call is unavailable.
Comment: One commenter suggested that that the phrase in
486.344(b)(1), ``pertaining to death and/or declaration of death,'' be
substituted for ``pertaining to organ donation.''
Response: We do not believe it is necessary to revise the text as
suggested by the commenter. Stating that when pronouncing death, an OPO
must abide by ``applicable'' State, Federal, and local laws and, in
addition, describing the laws as ``pertaining to death/and/or
declaration of death'' is unnecessarily descriptive. In fact, after
reviewing our proposed language in Sec. 486.344(b)(1), we have
concluded that the phrase ``pertaining to organ donation'' is not
[[Page 31022]]
necessary and could be confusing. Therefore, we have changed the
language in 486.344(b)(1) to read simply, ``Verify that death has been
pronounced according to applicable local, State, and Federal laws.''
Comment: One commenter said that the proposed requirement at
486.344(b)(2) for an OPO to ``determine whether there are conditions
that may contraindicate donation,'' is overly broad and too generally
stated. The commenter stated that it is unclear whether the language
refers to the overall quality of the donor or to organ-specific
decisions.
Response: We are not adopting this comment. We do not believe the
requirement is overly broad, as all donors must be evaluated by the OPO
for clinical contraindications to donation. Further, we have changed
the language to reflect the OPTN's requirement that potential donors be
evaluated to determine whether there are conditions that influence
donation. However, we have added the word ``potential donor'' to the
title of paragraph Sec. 486.344(b) to clarify that the evaluation
pertains only to the donor, not to specific organs.
Comment: One commenter said that with respect to the requirement
for OPOs to ``obtain the donor's vital signs and perform all pertinent
tests,'' CMS should require that the activities be performed according
to current OPTN standards.
Response: As we have stated previously, the ``rules and
requirements of the OPTN'' are those OPTN policies and bylaws that have
been approved formally by the Secretary by being published in the
Federal Register with an opportunity for the public to comment.
Therefore, simply adding language to a regulation that states OPOs must
adhere to OPTN standards is not sufficient. We must include the
specific language of the OPTN standard as a rule in order to make the
standard a requirement.
Comment: One commenter said that we should not use the term
``waiting list'' in the final rule because a ``waiting list'' is a pool
of transplant candidates, whereas, in the OPO community, the term
``match run'' is commonly used to describe a list generated to rank and
match potential transplant recipients with the donor's specific
characteristics. The commenter suggested that we use the terms ``match
run'' or ``match program'' instead of ``waiting list.''
Response: We agree with the commenter that the use of the term
``waiting list'' is misleading when used in this context. However, we
will not use the term ``match run'' or the term ``match program''
because of the possibility that the OPTN may change its terminology.
Therefore, in this final rule, we have revised Sec. 486.344(e) to
require OPOs to have written documentation from the OPTN showing, at a
minimum, the intended recipient's ranking in relation to other suitable
candidates.
Comment: Some commenters disagreed with our proposal specifying
that prior to recovery of an organ for transplant, the OPO must have
documentation from the OPTN showing, at a minimum, the intended organ
recipient's position on the waiting list in relation to other suitable
candidates and the recipient's OPTN identification number and blood
type. The commenters said that it would be impossible for OPOs to meet
this requirement because the OPO may not know the identity of the
recipient prior to organ recovery.
Response: Our proposal was intended only to require OPOs to obtain
documentation of the recipient's information when the identity of the
recipient is known prior to recovery of the organ. Clearly, if the
recipient has not yet been identified, the OPO cannot obtain such
documentation. We have clarified our language at Sec. 486.344(e) to
say, ``If the intended recipient has been identified prior to recovery
of an organ for transplantation, the OPO must have written
documentation from the OPTN showing, at a minimum, the intended
recipient's ranking in relation to other suitable candidates and the
recipient's OPTN identification number and blood type.''
Comment: A commenter recommended that to align practices between
OPO, OPTN, and transplant center policies for blood type verification,
CMS should not include the following proposed sentence in the final
rule: ``The protocol for organ placement must include procedures to
ensure that the blood type of the donor is compared with the blood type
of the intended recipient by two OPO staff.'' The commenter recommended
that instead, CMS should add the following sentences to the final rule,
``The OPO shall have two separate determinations of the donor's ABO
type prior to incision for ensuring the accuracy of the donor's ABO
during the OPTN match run. Each OPO shall establish and implement a
procedure for proving on-line verification by another OPO staff person
other than the one initially entering the donor's ABO into the OPTN
donor's registration. The protocol for organ placement must ensure that
all donor versus transplant candidate blood type verification will be
completed through the OPTN match run.''
Response: The language recommended by the commenter was taken from
the OPTN policies for verification of donor blood type. While we
believe it is advisable in many cases for us to align our requirements
for OPOs with the policies of the OPTN and the policies and procedures
of transplant centers, we believe the recommended language is too
specific and too prescriptive. If the OPTN were to change these
detailed policies, we could change our requirements, if necessary, only
by initiating rulemaking. However, in this final rule, we have added
additional detail to our proposed requirement that we believe will
satisfy the intent of the commenter. Therefore, this final rule
requires an OPO to have a protocol to ensure that: (1) The OPO is
responsible for two separate determinations of the donor's blood type;
(2) if the identity of the intended recipient is known, the OPO has a
procedure to ensure that prior to organ recovery, an individual from
the OPO's staff compares the blood type of the donor with the blood
type of the intended recipient, and the accuracy of the comparison is
verified by a different individual; and (3) documentation of the
donor's blood type accompanies the organ to the hospital where the
transplant will take place. Note that in meeting the requirements of
paragraph (2), the individual who verifies the donor's blood type does
not have to be from the OPO because a second member of the OPO's staff
may not be available for verification. Therefore, as an example, an
individual on the staff of the donor hospital could verify the donor's
blood type.
Comment: A commenter objected to our use of the term ``best
practices'' in 486.344(d)(2). The commenter said that the use and
interpretation of ``best practices'' in this context would be
problematic, since there is no consensus on ``best practices'' for
donor evaluation and management or organ placement and recovery. The
commenter said that in using the term ``best practices,'' CMS would be
mandating ``extremely unclear'' standards subject to the interpretation
that OPOs should be held to standards far in excess of ``typical
standards.''
Response: We agree with the commenter that the use of the term
``best practices'' could be problematic. We will rephrase our proposed
language to clarify our intention that in collaboration with their
transplant centers, OPOs must regularly reassess their protocols for
potential donor evaluation and management and organ
[[Page 31023]]
placement and recovery to incorporate practices that have been shown to
maximize organ donation and transplantation. Therefore, we have removed
the term ``best practices'' from the language and moved the language in
the proposed Sec. 486.344(d)(2) to Sec. 486.344(d)(3) in the final
rule. Thus, in Sec. 486.344(d)(3), we require OPOs to review their
established protocols regularly with their transplant programs ``to
incorporate practices that have been shown to maximize organ donation
and transplantation.''
Section 486.346 Condition: Organ Preparation and Transport
We proposed that OPOs must arrange for organs to be tested for
infectious diseases according to the current standards of practice by
appropriately certified laboratories.
We also proposed that OPOs would be required to send complete
documentation of donor information with the organ(s) to the transplant
center and that the information must include donor evaluation, the
complete record of the donor's management, as well as documentation of
consent, pronouncement of death, and determination of organ quality. In
addition, we proposed requiring that two OPO staff members must verify
the accuracy of the information being sent with the organ(s).
We proposed that OPOs develop and follow a written protocol for
packaging, labeling, handling, and shipping organs in a manner that
ensures that they arrive without compromising the quality of the organ
or the health of the recipient. We proposed that this protocol must
include procedures to check the accuracy and integrity of labels,
packaging, and contents prior to transport, including verification by
two OPO staff members that information listed on the labels is correct.
We proposed that all of the packaging for the organ(s) must be marked
with the identification number, specific contents, and donor's blood
type.
We received several comments on this section. Commenters expressed
a great deal of concern over how some of the language could affect the
donation process, as well as the OPO's potential liability under state
tort laws. We have summarized those comments below and explained the
changes we have made to the regulation text.
Comment: One commenter questioned the need for this proposed
section. The commenter noted that UNOS had determined ``that the root
cause of many of these errors involved the reuse of organ shipping
boxes.'' Commenters also noted that the OPTN/UNOS Board of Directors
had instituted policy changes that prohibit reuse of organ shipment
boxes and implemented requirements that are the same as those proposed
by CMS.
Response: Although the OPTN/UNOS Board of Directors have instituted
policy changes similar or even identical to those in this provision,
this section is needed to make them mandatory for the OPOs and to
enable CMS to enforce these requirements. Thus, we will be finalizing
this condition with only the three revisions discussed in the comments
and responses below.
Comment: A commenter noted that the proposed rule would require two
OPO staff members to verify that the labels, packaging, and contents
are correct prior to transport. However, the commenter said that there
may be only one OPO staff member present in the operating room when the
organs are packaged. The commenter said that we should not require both
individuals who check the labels, packaging, and contents to be OPO
employees.
Response: We agree with the commenter. There may be times when two
OPO staff members are not available to verify that organs are correctly
packaged and labeled. Thus, we will revise the language in the proposed
Sec. 486.346(c) to read, ``* * *. The protocol must include procedures
to check the accuracy and integrity of labels, packaging, and contents
prior to transport, including verification by two individuals, one of
whom must be an OPO employee, that information listed on the labels is
correct.''
Comment: A commenter expressed concern about ``language suggesting
that the OPO would be held responsible for ensuring that an organ would
not compromise the health of a recipient.'' The commenter stated that
the transplant center decides whether to transplant a particular organ
into a particular recipient. Thus, the transplant center's decision
affects the recipient's health, not any decision or action by an OPO.
The commenter pointed out that the OPO cannot always control what
happens to the organ once it leaves the OPO for transport to the
transplant hospitals.
Response: We understand the commenter's concern regarding the
proposed language, ``The OPO must develop and follow a written protocol
for packaging, labeling, handling, and shipping organs in a manner that
ensures their arrival without compromise to the quality of the organ or
health of the recipient.'' [Emphasis added.] The OPO is responsible for
ensuring that an organ(s) arrive at the transplant center ``without
compromise to the quality of the organ,'' because it is the OPO that
labels, packages, handles, and ships the organ(s) to the transplant
center. However, the transplant center, specifically the transplant
surgeon, makes the decision to transplant a particular organ(s) into a
particular patient and, thus, is responsible for the health of the
recipient. Thus, we have revised Sec. 486.346(c) by deleting the words
``or health of the recipient.''
Comment: A commenter submitted a new form that he developed that
would be sent to UNOS with the intent that copies would be kept with
the UNOS donor documentation at the transplanting OPO.
Response: CMS is not the appropriate agency to review the submitted
form. Therefore, we have forwarded the form to HRSA for review by the
OPTN. This regulation does not require OPOs to use a specific form.
Comment: One commenter said that there should be an ``enforceable
consequence'' for making errors in the packaging and transporting of
organs. If the errors continued, the commenters indicated, ``immediate
decertification should be implemented even if the OPO is meeting the
established criteria to maintain its certification.''
Response: We agree with the commenter that there must be an
enforceable consequence for making errors in the packaging and
transportation of organs. As discussed earlier in this preamble, OPOs
are required to satisfy all requirements of the conditions for coverage
in this final regulation. An OPO's failure to satisfy any of these
requirements, including those in this condition, could result in action
being taken by CMS. The severity of the action depends upon the
severity of the deficiency. However, an immediate de-certification
would be based on urgent need. (See discussion in this preamble of the
definition of ``urgent need'' in ``Definitions (proposed Sec.
486.302)'' and ``De-Certification (proposed Sec. 486.312).''
Condition: Quality Assessment and Performance Improvement (QAPI) Sec.
486.348
We proposed that OPOs must develop, implement, and maintain a
comprehensive, data-driven QAPI program that is designed to monitor and
evaluate performance of all donation services, including services
provided under a contract or an agreement. We proposed that the QAPI
program must include objective measures to evaluate and demonstrate
improved performance with regard to OPO activities. We included
examples of components that
[[Page 31024]]
should be included in a QAPI program: hospital development, designated
requestor training, donor management, timeliness of on-site response to
hospital referrals, consent practices, organ recovery and placement,
and organ packaging and transport. (Hospital development refers to an
OPO's activities related to developing good working relationships with
the hospitals with which the OPO has an agreement.) We also proposed
requiring OPOs to take actions that will result in performance
improvements and to track performance to ensure that improvements are
sustained.
We proposed that each OPO must conduct death record reviews as part
of its QAPI program. We proposed requiring OPOs to conduct death record
reviews in every Medicare and Medicaid participating hospital in its
service area that has a Level I or Level II trauma center or 150 or
more beds (unless the hospital has a waiver to work with another OPO),
with the exception of psychiatric and rehabilitation hospitals. We
proposed that when an OPO identifies missed opportunities for donation,
it must implement actions to improve its performance.
We proposed defining an adverse event ``as an untoward,
undesirable, and usually unanticipated event that causes death or
serious injury or the risk thereof.'' We indicated that for OPOs,
adverse events would include, but were not limited to transmission of
disease from a donor to a recipient, avoidable loss of a medically
suitable potential donor for whom consent for donation has been
obtained, or delivery to a transplant center of the wrong organ or an
organ whose blood type does not match the blood type of the intended
recipient.
We proposed that an OPO be required to establish a written policy
to address adverse events that occur during any phase of an organ
donation case. We proposed that at a minimum, the policy must address a
process for the identification, reporting, analysis, and prevention of
adverse events. Under the proposed rule, an OPO would be required to
conduct a thorough analysis of any adverse event they identify and use
their analysis to change its policies and practices to prevent any
reoccurrence of similar incidents. In addition, we proposed that an OPO
be required to report an adverse event to us within 10 business days of
becoming aware of the event and provide written documentation of the
investigation and analysis of the adverse event to us within 15 days of
becoming aware of the event.
Comment: Many commenters wrote to us expressing their approval of
the requirement to establish a QAPI program. Most who commented on the
proposed QAPI requirement specifically endorsed the language in
proposed Sec. 486.348(a). One commenter suggested that an OPO QAPI
program should include specific goals to enhance consent rates and the
quality of donor management.
Response: We appreciate the overwhelming support expressed by
commenters for a QAPI program requirement. We agree that increasing
consent and the quality of donor management are worthy goals for OPO
QAPI programs. In fact, the regulations text of the February 4, 2005
proposed rule lists examples of OPO activities for which OPOs can
develop objective measures to evaluate and demonstrate improved
performance and includes donor management and consent practices.
However, in this final rule, we do not mandate that OPOs include any
specific activities in their QAPI programs. OPO operations and function
vary throughout the country, along with the demographics within each
OPO's service area. We believe it is important to give an OPO
sufficient flexibility to design its QAPI program in a manner that will
raise its level of performance, given the OPO's specific weaknesses and
strengths. Therefore, we are finalizing Sec. 486.348(a) as proposed.
Comment: Most commenters supported our proposal to require an OPO
to perform death record reviews in every Medicare and Medicaid
participating hospital in its service area that has a Level I or Level
II trauma center or 150 or more beds (unless a hospital has a waiver to
work with another OPO), with the exception of psychiatric and
rehabilitation hospitals. However, some commenters recommended that we
change the language slightly so that the requirement would read, ``150
or more acute care beds, a ventilator and an ICU * * *''
Response: We believe this change is reasonable in part, because a
hospital without a ventilator would be unable to maintain a potential
donor, and a hospital without an intensive care unit is unlikely to
have 150 or more beds. However, we disagree that death record reviews
should be limited to hospitals with 150 or more ``acute care'' beds.
Medicare does not recognize the term ``acute care bed'' for
certification purposes. For example, in recent years, many hospitals
have been converting some hospital units to ``sub-acute care units'' or
``a hospital within a hospital.'' Unless such a unit or ``hospital''
becomes a separate provider and provider type (such as a skilled
nursing facility), Medicare regards the beds in these units or
``hospitals'' as hospital beds. However, an OPO might argue that such
beds are not ``acute care'' beds. We believe using this term would lead
to confusion and could lead OPOs to overlook some hospitals with
significant donor potential. Therefore, we have modified the
requirement to say that an OPO is required to perform death record
reviews in hospitals with 150 or more beds, a ventilator, and an
intensive care unit.
Comment: Some commenters recommended that we establish requirements
for the frequency of conducting death record reviews. One commenter
stated that some OPOs do not perform death record reviews, even in
their large hospitals and that other OPOs conduct death record reviews
only annually. One commenter suggested that we should require OPOs to
perform death record reviews monthly for hospitals with 200 or more
beds that have an emergency department, an operating room, and an
intensive care unit.
Response: As we stated in the preamble to our February 4, 2005
proposed rule, death record reviews are a critical component of any
QAPI program. They form the foundation every OPO needs to assess its
own performance and the performance of its hospitals so that missed
opportunities for donation can be identified and changes made to
address the problem. It is important for death record reviews to be
performed frequently in large hospitals with the greatest donation
potential. HRSA and the CMS OPO Coordinators report that many
successful OPOs perform death record reviews weekly in their large
hospitals. Some OPOs even perform death record reviews in ``real
time.''
Therefore, we agree with the commenters who urged us to establish a
time frame for death record reviews. However, we do not agree with the
commenter who suggested 200 beds as the appropriate parameter. A recent
study found that 19 percent of hospitals account for 80 percent of
potential donors. Hospitals with 150 or more beds were more likely than
smaller hospitals to have both potential donors and actual donors. (E
Sheehy, S Conrad, L Brigham, et al, Estimating the Number of Potential
Organ Donors in the United States; New England Journal of Medicine,
Vol. 349: 667-674, August 14, 2003). We believe that performing death
record reviews monthly in these large hospitals is both reasonable and
absolutely necessary for an OPO to
[[Page 31025]]
determine where it needs to improve. Therefore, in this final rule, we
require OPOs to perform death record reviews at least monthly in every
Medicare and Medicaid participating hospital in its service area that
has a Level I or Level II trauma center or 150 or more beds, a
ventilator, and an intensive care unit (unless a hospital has a waiver
to work with another OPO), with the exception of psychiatric and
rehabilitation hospitals.
Comment: Many commenters said that the performance of death record
reviews should be standardized, so that death record review practices
are uniform and the reviews are performed correctly. Some commenters
suggested that HRSA should establish a technical assistance program to
train OPOs; one commenter said that CMS should hire staff to review
results of OPO medical record reviews.
Response: We disagree that the Federal Government should be
responsible for teaching the OPOs how to conduct death record reviews.
Each OPO should put into place a system to make sure that staff who
perform death record reviews are qualified and trained to perform the
reviews correctly. Further, we would expect that as part of its QAPI
program, every OPO would have a procedure to check the accuracy of the
death record reviews after they are performed. Therefore, we are not
adopting the commenters' suggestion.
Comment: A few commenters were concerned about using data obtained
from death record reviews performed by OPOs. They said that the data,
especially data concerning missed referrals, should not be used in the
outcome measures until there is a uniform death record review procedure
used by all OPOs. One commenter said there could be inter-OPO
variations.
Response: Although there is some potential for intra-and/or inter-
OPO variability in performing death record reviews, we would point out
that any system for conducting death record reviews has some potential
for variability. However, we believe that death record reviews will
increase organ donation because these reviews will enable OPOs to
identify any problems that result in missed opportunities for donation
so that they can make changes to address those problems. In addition,
since the information in the OPO's death record reviews will be
included in the statistical measures for re-certification, it is in
each OPO's best interest to develop procedures and processes to ensure
that their death record reviews are accurate and valid.
Further, we are adopting the same definition of ``eligible deaths''
that the OPTN uses. This should promote consistency in the reporting of
the data if the death record reviews are conducted by staff with the
appropriate background and training. As we stated earlier in this
preamble, the CMS Regional OPO Coordinators are available to work with
the OPOs in implementing their QAPI programs, including the OPOs'
performance of death record reviews. Also, we will work with HRSA to
determine whether a procedure can be established to assist OPOs that
are not sure whether a particular death was an eligible death.
Comment: A few commenters said that there should be some type of
validation of the data from death record reviews. Two commenters noted
that the current OPTN database requires additional validation. One
commenter suggested that CMS surveyors compare death record review
results with the SRTR's research on eligible deaths.
Response: We appreciate the recommendation that death record review
results should be validated. However, we must point out that OPOs are
responsible for ensuring that the data they submit to the OPTN are
valid. As stated above, we expect that every OPO will have a procedure
to check the accuracy of the death record reviews after they are
performed.
Also, it is important to note that the donation rate outcome
measures in this final rule are based on both self-reported data and
the SRTR statistical methodology. Although the number of ``eligible
deaths'' is reported by OPOs to the OPTN, the number of ``notifiable
deaths'' (the subset of all in-hospital deaths age 0-70 with no
exclusionary medical diagnoses for possible donation) is calculated by
the SRTR based on data from the Office of Analysis and Epidemiology,
National Center for Health Statistics, Centers for Disease Control and
Prevention. By assessing an OPO's reported number of eligible deaths in
view of its notifiable deaths, the SRTR can ascertain whether the data
reported by an OPO are likely to be correct. If the data indicate that
an OPO may not be reporting the number of eligible deaths in its
donation service area correctly, CMS will regard this information as a
complaint and will conduct a complaint investigation of the OPO.
Comment: One commenter suggested we add ``* * * language to hold
hospitals accountable to provide computerized mortality lists within 15
days of the last day of the month and work to provide for timely review
of records to all donation agencies.'' This same commenter also
encouraged the ``* * * hiring of CMS representatives to begin to review
results of OPO medical record reviews and reports to hospitals and for
CMS to set guidelines on how and when those fines would be
established.''
Response: We support hospitals providing timely information to the
OPOs. However, this final rule is a regulation for OPOs; hospital
performance is not within the purview of this regulation.
Adverse Event Definition
Comment: Some commenters requested that CMS clarify the definition
of ``adverse event.'' Commenters stated that the proposed definition
was too broad or that it should be limited to situations where there
was an immediate risk to the patient.
Response: We agree that the definition of ``adverse event is broad
and could be subject to varying interpretations. We would expect that
as part of an OPO's effort to develop, implement and maintain a
comprehensive, data-driven QAPI program, the OPO would customize the
definition of ``adverse event'' in their written policies to meet their
own needs, as well as ensure compliance with the QAPI requirements.
Therefore, we have finalized the definition as proposed.
Adverse Event Reporting
Comment: While most of the comments were supportive of adverse
event identification and analysis, many of the commenters were
concerned about the reporting requirement. Many commenters said that
their major concerns were related to the mechanical issues of
reporting. Their primary concern, however, was whether CMS would be
able to keep the information confidential or whether we would be
required to release it under the Freedom of Information Act (FOIA).
Other commenters were concerned about their liability should the
information become public. Some commenters were also concerned over how
CMS would use the information; specifically, they wanted to know if CMS
intended to use the information in future re-certification or
designation decisions.
Other specific issues identified by commenters included the need
to: Clarify what constitutes a ``business day;'' expand the 5-day
timeframe between the initial report and the second report to give the
OPO adequate time for a thorough analysis of the incident; and, clarify
CMS's intention to publish or share this information (without
identifying information) so that
[[Page 31026]]
other OPOs can avoid similar incidents. Commenters recommended that CMS
address these specific issues before mandating a requirement of this
nature. Commenters also expressed concern regarding the broad approach
to addressing adverse events ``that occur during any phase of an organ
donation case'' as part of an OPO's QAPI program.
Commenters also noted the proposed rule for Transplant Centers,
CMS-3835-P, that was published on February 4, 2005, has a requirement
that transplant centers ``establish and implement written policies to
address adverse events that occur during any phase of the organ
transplantation case.'' (Sec. 482.96(b)). However, there is no
reporting requirement for transplant hospitals that corresponds to the
proposed reporting requirement for OPOs.
Response: Based on public comments, we have deleted the reporting
requirement in this final rule. We have retained the requirement that
OPOs establish and implement written policies to address, at a minimum,
the process for identification, reporting, analysis, and prevention of
adverse events. We agree that the phrase referring to adverse events
``that occur during any phase of an organ donation case'' needs to be
clarified. We believe that an OPO should be responsible for the
identification, reporting, analysis and prevention of any adverse
events that occur during the organ donation process. We believe that
this process begins when an OPO is notified by the hospital or critical
access hospital of a death or imminent death and concludes when the
organ(s) are delivered to a transplant center. It would also include
any adverse events that were identified or occurred at a transplant
center but the root cause of the adverse event appears to have occurred
before the organ(s) arrived at the transplant center. * * * (should be
say anything about organs for research-based on our definition of
adverse event it appears it would have to be something that could
affect a patient? Also, what about tissue?) Thus, Sec. 486.348(c)(1)
will be revised to read ``An OPO must establish written policies to
address, at a minimum, the process for identification, reporting,
analysis, and prevention of adverse events that occur during the organ
donation process.''
We have also retained the requirement that OPOs must conduct a
thorough analysis of any adverse event and must use the analysis to
affect changes in OPO policies and practices to prevent repeat
incidents. Although CMS will not receive written reports from OPOs on
identified adverse events, a description of the adverse event, the
circumstances surrounding the incident, the OPO's analysis and
subsequent policy and practice changes must be available on-site at the
OPO for the OPO coordinator's and surveyor's use in reviewing this
information and monitoring the OPOs' response to an adverse event.
Additional Conforming Changes (Sec. 413.200, Sec. 413.202, Sec.
441.13, and Sec. 498.2)
In addition to the changes discussed above, we also proposed a
number of conforming and correcting amendments.
As discussed previously, we proposed making changes to Sec. 498.1
to remove OPOs from the definition of ``supplier'' under part 498.
Since we proposed an alternate process for OPOs to appeal a de-
certification on substantive and procedural grounds, OPOs would not
need the part 498 appeals process.
We also proposed to correct a number of cross-references related to
the certification of OPOs. In Sec. 441.13(c), and in Sec. 498.2, we
proposed to change references to ``part 485, subpart D'' to read,
``part 486, subpart G''. On September 29, 1995 (60 FR 50447), the
conditions for coverage for OPOs was re-designated from part 485,
subpart D to part 486, subpart G. When this re-designation occurred,
these two references were not amended to reflect the change.
In addition, Sec. 413.202 refers to OPOs ``as defined in Sec.
435.302 or this chapter''. This is an error. We proposed correcting
this reference to read ``as defined in Sec. 486.302 of this chapter''.
We received no public comments on these conforming changes in the
proposed provisions. Therefore, we are adopting the provisions as final
without change.
Living Donation
In the February 4, 2005 proposed rule, we noted that living
donation was becoming increasingly important. In 2001, for the first
time, living donors outnumbered deceased donors, with 6,445 living
donors and 6,077 deceased donors. In 2004, there were 7,150 living
donors and 7,004 deceased donors. However, OPOs do not play a role in
living donation, with the exception of two pilot programs in which OPOs
assist transplant hospitals by arranging for medical and psychological
evaluations of living kidney donors. We stated that the mission of the
OPOs was to increase the number of deceased donors. However, in view of
the increasing importance of living donation, we specifically requested
public comments on what, if any, role OPOs should play in living
donation.
Comment: Commenters had very diverse views on what role, if any, an
OPO should play in living donation. Many commenters recognized the
importance of living donation but stated that the OPOs' core or primary
mission is increasing donation from deceased donors. Some commenters
expressed concern that living donation could divert resources that
should be directed to increasing deceased donation. Further, commenters
did not want living donation to play any part in how we evaluate an
OPO's performance.
Some commenters were strongly opposed to OPOs having any role. One
commenter noted that the OPOs do not have the skills or staffing to
address living donors' needs and that this could strain the OPO's
relationships with their hospitals. Some commenters felt that if the
OPOs played any role, it should be a very limited one. Another
commenter suggested that OPOs simply refer any inquiries to their
transplant centers.
One commenter wanted to limit the OPOs that could be involved in
living donation. That commenter noted that devoting resources to living
donation would only divert the OPO's resources from increasing deceased
donation. Therefore, unless an OPO is in the top one-third of
performing OPOs, an OPO should not be required to play any role in
living donation. This commenter said that living donation should be
arranged between the potential donors and the transplant center.
Conversely, one OPO indicated that some OPOs are recognized as the
sources of information on both deceased and living donation and receive
many questions from both individuals and volunteer groups concerning
living donation. The commenter said that OPOs should play a
coordination role, especially when it concerns unrelated living donors.
One commenter suggested that OPOs could play a role by including
information on living donation in their public education efforts. Other
commenters simply said that OPOs should play a more active role in
living donation.
Response: We agree that living donation should not play any role in
the evaluation of an OPO's performance. As many commenters stated, the
OPOs' core mission is increasing donation from deceased donors.
Therefore, we will continue to evaluate OPOs only on their performance
in regard to deceased donation.
Further, we share the concern some commenters expressed that an
OPO's involvement in living donation could result in the diversion of
resources from
[[Page 31027]]
its core mission. As we stated in the proposed rule, given the
demonstrated risks to living donors (primarily living liver donors), we
believe that living donation should remain a medical decision between
individuals interested in donating and their physicians. Thus, our
expectation is that OPOs will have only limited involvement in living
donation, and we will not be including any requirement concerning
living donation in this final regulation.
Public Education
In the February 4, 2005 proposed rule, we noted that the current
regulations contained a requirement for professional education but no
requirement for public education. We also noted that most OPOs were
aware of how important public education is in ``reaching ethnic
populations, dispelling myths about organ donation, and addressing
other issues that create barriers for consent to donation.'' However,
we acknowledged that some researchers believe that available funding
should go to basic research, professional education, and hospital
development rather than public education. We said, ``While we believe
that systematic efforts by OPOs to identify specific barriers to
donation, along with public education programs designed to address
those barriers, may result in increased rates of consent to donation
among targeted populations, the OPO community appears to lack consensus
about this issue.'' Thus, we specifically requested comments on whether
we should require OPOs to conduct public education based on systematic
evaluation of specific barriers to donation within their individual
service areas.
Comment: Many commenters stated that they were very supportive of
OPOs conducting public education and believed that it was very
important in increasing donation. Some commenters noted that they had
already seen increases in individuals signed up for donor registries
due to public education. Another commenter noted that it was important
to conduct public education in addition to professional education.
However, one commenter noted that it can be difficult to determine the
effectiveness of public education and other commenters noted that
public education is really a long-term process, and the positive
effects may not be seen for months or years.
Many commenters were supportive of including a general requirement
in this final regulation for OPOs to provide public education. Some
commenters wanted the requirement to be more specific, such as
assessing and targeting or focusing on specific needs in an OPO's
donation service area. One commenter said that we should require OPOs
to include their public education efforts in their QAPI programs.
Another commenter expressed concern that the lack of a requirement for
public education in CMS regulations may hinder or even discourage
public education efforts by OPOs. Other commenters believed that even
if we did not make this a requirement, we should encourage OPOs to
conduct public education.
Response: Although we agree with the commenters who emphasized the
importance of public education, we also agree with the commenter who
said that it is difficult to determine the effectiveness of public
education. Clearly, public education is important for increasing public
awareness of the importance of donation, and it appears that most, if
not all, OPOs conduct some public education efforts. However, we
believe that OPOs need the flexibility to decide how they will use
their educational resources. Many OPOs may need to devote resources to
public education; however, other OPOs may have a greater need for
professional education. Thus, although we certainly encourage OPOs to
assess the needs for public education in their donation service areas
and address them and appreciate the comments we received, we will not
be incorporating a requirement for public education in this final
regulation.
III. Provisions of the Final Rule
In this final rule we are adopting the provisions as set forth in
the February 4, 2005 proposed rule with the following revisions:
Amend Sec. 486.301, ``Basis and scope'' by revising paragraph
(b)(4) to clarify that the scope of the subpart sets forth the
requirements for an OPO to be re-certified.
Amend 486.302, ``Definitions'' by--
Revising the definition of ``certification'' with minor
clarifying changes that are discussed in this preamble under
``Certification (proposed Sec. 486.303).''
Amending the definition of ``de-certification'' by
removing language related to specific conditions, measures, and
requirements and revising it so to be consistent with the definition of
``certification.''
Amending the definition of ``designated requestor'' by
adding language to state that a ``designated requestor'' is also known
as an ``effective requestor.''
Revising the term ``service area'' to read ``donation
service area (DSA)'', so that our terminology is consistent with the
terminology generally used and accepted in the OPO and transplant
communities. We have adopted the definition as proposed.
Revising the definition for ``re-certification cycle.''
Adding the following definitions to this final rule:
``donor after cardiac death'', ``eligible death'', ``eligible donor'',
``expected donation rate'', ``observed donation rate,'' and ``standard
criteria donor (SCD)'' These terms were not proposed in our February 4,
2005 rule. Because we will be using data from the OPTN and the SRTR in
assessing whether OPOs have satisfied these outcome measures, we are
adopting the definitions currently used by the OPTN and SRTR in their
statistical evaluation of OPO performance.
Adding the term ``urgent need''. This occurs when an OPO's
noncompliance with one or more conditions for coverage has caused, or
is likely to cause, serious injury, harm, impairment, or death to an
organ recipient.
Amend Sec. 486.303, ``Requirements for certification'' by--
Revising to make conforming changes we made to Sec.
486.312 (De-certification).
Revising paragraph (a) to state that in order to be
certified as a qualified OPO, an OPO must have received a grant under
42 U.S.C. 273(a) or have been certified or re-certified by the
Secretary within the previous 4 years as being a qualified OPO.
Revising Sec. 486.304 ``Requirements for Designation'' by
moving some standards to other conditions of coverage or deleting them.
We moved the requirements for designation at Sec. 486.304(a) through
(c)(1) and combined them with the requirements for certification at
Sec. 486.303. We deleted the requirements at Sec. 486.304 (c)(2)
through (c)(7) that specify elements of the agreement. The remaining
elements of the agreement with CMS specified at Sec. 486.304(c)(3)
through (c)(7) are standard elements of provider/supplier agreements
with CMS and will be addressed in manual instructions. The requirements
at Sec. 486.304(d) Application for designation has been moved to Sec.
486.316 Re-certification and competition processes. Finally, the
requirements at Sec. 486.304(e) Designation periods have been moved to
Sec. 486.308. The changes are identified in the following crosswalk:
------------------------------------------------------------------------
Proposed Final
------------------------------------------------------------------------
Sec. 486.304(a)-(c)(1).................. Moved to Sec. 486.303.
Sec. 486.304(c)(2)-(c)(7)............... Deleted.
[[Page 31028]]
Sec. 486.304(d)......................... Moved to Sec. 486.316.
Sec. 486.304(e)......................... Moved to Sec. 486.308.
------------------------------------------------------------------------
Amend Sec. 486.306, ``OPO service area size designation and
documentation requirements'' by revising paragraph (d)(2) to permit an
exception for an OPO whose service area includes Hawaii and does not
include any part of the continental United States.
Amend Sec. 486.308, ``Designation of one OPO for each service
area'' by--
Redesignating Sec. 486.308(b) through Sec. 486.308(f) as
Sec. 486.308(c) through Sec. 486.308(g) and adding Sec. 486.308(b).
Newly added paragraph (b) was relocated from Sec. 486.304(c) as part
of our reorganization and clarification in this final rule of the
sections that address certification and designation.
Amend Sec. 486.309, ``Re-certification from August 1, 2006 through
July 31, 2010'' to specify that OPOs that were certified by CMS in the
past and currently have agreements with the Secretary are re-certified
August 1, 2006 through July 31, 2010 and the current agreements will be
extended through January 31, 2011.
Amend Sec. 486.310, Changes in control or ownership or service
area by clarifying that this section applies to changes in the control
over an OPO, as well as changes in ownership or in an OPO s service
area.
Amend Sec. 486.312, ``De-certification'' by--
Clarifying in paragraph (b) that de-certification due to
involuntary termination of an agreement occurs ``during the term of the
agreement.''
Clarifying paragraph (c) de-certification due to non-
renewal of an agreement. We removed our proposed language ``or if the
OPO s designation status has been terminated'' because we have
streamlined the requirement by including requirements for designation
status at Sec. 486.303. We added language that requires the OPO to
meet the requirements for certification at Sec. 486.303. We made these
revisions to clarify that CMS's decision not to renew an OPO's
agreement is not based on a single requirement but rather is based on
multiple outcome measures and other information collected over the
course of the 4-year agreement, consistent with statutory requirements.
Amend Sec. 486.314, ``Appeals'' by--
Revising the appeals section to expand the circumstances
under which an OPO can appeal a decertification due to involuntary
termination or non-renewal of its agreement with us to include both
substantive and procedural grounds. We also establish new procedures
for notice of an initial decertification determination, requirements
for evidence and the OPO's right to reconsideration. To avoid undue
procedural delays, the final rule also establishes a time-sensitive
process by which an OPO can request reconsideration, other requirements
for filing, and a hearing before a hearing officer. Further, to ensure
that protections available in existing regulations were maintained, the
appeals process was expanded to specify CMS requirements for
reconsiderations, hearings, standards of evidence.
Amend Sec. 486.316, ``Re-certification and competion processes''
by--
Removing the proposed requirement that all OPO service
areas are open for competition at the end of every recertification
cycle. Under this final rule, an OPO that meets the following criteria
will be re-certified for an additional 4 years and its service area
will not be opened for competition if the OPO: (1) Meets all 3 of the
outcome measure requirements in 486.318; (2) meets the requirements for
certification at 486.303 and (3) has been shown by survey to be in
compliance with the conditions for coverage at 486.320 through 486.348.
Revising the section to establish that the contiguity of a
competing OPO s service area to that of an open area is one of the
factors that we will consider when selecting the OPO for designation of
the open area.
Amend Sec. 486.318, ``Condition: Outcome measures'' by--
Establishing 3 revised outcome measures for OPOs that
differ from what we proposed: (1) Donation rate; (we will account for
DCDs and donors over the age of 70 by adding a 1 to both the numerator
and the denominator); (2) observed donation rate compared to the
expected donation rate, as calculated by the SRTR; and (3) a yield
measure for both organs transplanted per donor (including pancreata
used for islet cell transplantation) and organs used for research per
donor. We are not adopting the proposed outcome measures.
Removing, from the revised outcome measures, the
distinction between kidneys and extra-renal organs, except for OPOs
operating exclusively in non-contiguous U.S. States, commonwealths,
territories, and possessions.
Revising the outcome measure for OPOs operating
exclusively in non-contiguous U.S. States, commonwealths, territories,
or possessions.
Amend Sec. 486.320, ``Condition: Participation in organ
procurement and transplantation network'' by revising the section to
include language that requires OPOs to ``participate'' in the OPTN.
Amend Sec. 486.322, ``Condition: Relationships with hospitals,
critical access hospitals, and tissue banks'' by--
Revising to clarify that the OPO is required only to offer
to provide designated requestor training annually. If a hospital does
not want training, the OPO is not required to provide it.
Revising to require OPOs to cooperate with tissue banks in
offering designated requestor training.
Amend Sec. 486.324, ``Condition: Administration and governing
body'' by revising to clarify that tissue bank members may be from the
OPO's tissue bank or any other tissue bank of the OPO's choice. It is
not necessary that the tissue bank member represent all tissue banks in
the service area.
Amend Sec. 486.326, ``Condition: Human resources,'' by revising
paragraph (b)(1), by inserting the words ``for organ and/or tissue
donation'' before ``in a timely manner.''
Amend Sec. 486.328, ``Condition: Reporting of data'' by removing
paragraph (d) that requires the OPO to report hospital-specific organ
donation data, including organ donor potential and the number of
donors, to the public at least annually, because that data is readily
available on the SRTR website. We also revised Sec. 486.328(a) to
remove the term ``potential donor denominator'' and added the terms
``eligible deaths'' and ``eligible donors''. In addition, in Sec.
486.328(b) we clarified that an OPO must provide hospital-specific
organ donation data annually to the transplant hospital with which it
has agreements.
Amend Sec. 486.330, ``Condition: Information management'' by
adding ``electronic'' before information management system in the
introductory text.
Amend Sec. 486.342 ``Condition: Requesting consent'' by revising
paragraph (a)(8) to read, ``Contact information for individuals with
questions or concerns.''
Amend Sec. 486.344 ``Condition: Donor evaluation and management
and organ placement and recovery'' by--
Removing, the word ``physician'' in paragraph (a)(2) and
replacing it with the word ``individual'' to provide OPO's with the
flexibility to determine who will assist in medically managing
potential donor cases.
Adding the word ``potential donor'' to the heading of
Sec. 486.344(b) to clarify the evaluation pertains only to the donor,
not the specific organs.
Removing the phrase ``pertaining to organ donation'' in
paragraph (b)(1) because it is not necessary and could be confusing. We
have revised paragraph
[[Page 31029]]
(b)(1) to read simply, ``Verify that death has been pronounced
according to applicable local, state, and federal laws.''
Revising paragraph (e) to require OPOs to have written
documentation from the OPTN showing at a minimum, the intended
recipients ranking in relation to other suitable candidates.
Amend Sec. 486.346, ``Condition: Organ preparation and transport''
by--
Removing the words ``OPO staff members'' and inserting
``individuals, one of whom must be an OPO employee,'' in paragraph (b)
Removing the words, ``or health of the recipient.'' after
the words ``quality of the organ'' in paragraph (c) and removing the
words, ``OPO staff members'' and inserting the words, ``individuals,
one of whom must be an OPO employee,'' in the last sentence.
Amend Sec. 486.348 ``Condition: Quality assessment and performance
improvement (QAPI)'' by--
Adding a requirement for OPOs to develop, implement, and
maintain a QAPI program that is designed to monitor and evaluate the
performance of all donation services.
Adding a requirement that the OPO's QAPI program include
objective measures designed to evaluate and demonstrate improved
performance with regard to OPO activities, including services provided
under contract or arrangement.
Adding a requirement that OPOs conduct death record
reviews at least once a month in every Medicare- and Medicaid-
participating hospital in its service area that has a level I or level
II trauma center or 150 or more beds, a ventilator, and an intensive
care unit. There is an exception for any hospital that has been granted
a waiver to work with another OPO and psychiatric and rehabilitation
hospitals.
Revising paragraph (c) to require that ``[a]n OPO must
establish written policies to address at a minimum, the process for
identification, reporting, analysis, and prevention of adverse
events.''
Removing paragraph (c)(3) which had required that OPOs
report adverse events to CMS.
IV. Collection of Information Requirement
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
Section 486.306 OPO Service Area Size Designation and Documentation
Requirements
Section 486.306(a) states that an OPO must make available to CMS
documentation which verifies that it meets the requirements of
paragraphs (b) through (d) of this section at the time of application
and throughout the period of its designation.
The burden associated with this requirement is the time and effort
it would take for an OPO to provide such documentation to CMS. We
estimate that it would take one OPO 30 minutes to gather the
documentation necessary for such verification. In order to conduct
business, an OPO would need to have all of this data readily available.
The requirement for the retention of documentation of this type is
usual and customary business practice. Therefore, we estimate the
annual burden hours for this requirement to be 29 hours.
Section 486.306(c)(1) through (3) requires an OPO to define and
document a proposed service area's location and characteristics through
the following information:
(1) The names of counties (or parishes in Louisiana) served or, if
the service area includes an entire State, the name of the State.
(2) Geographic boundaries of the service area.
(3) The number of and the names of hospitals and critical access
hospitals in the service area that have both a ventilator and an
operating room.
The burden associated with this requirement is the time and effort
necessary for an OPO to document such information. We estimated that it
would take a typical OPO an average of 1 hour to document such
information. There are 58 OPOs that would have to comply with this
requirement; therefore, there would be a total of 58 hours needed to
comply annually.
------------------------------------------------------------------------
Annual burden Annual cost
Hours/est. salary/ of OPOs hours estimate
------------------------------------------------------------------------
1 organ procurement coordinator (RN or 29.00 $779.23
SW) @ $26.87 hr. x \1/2\ hr. annually
per 58 OPOs x 58 OPOs..................
1 secretary @ $16.11/hr. x \1/2\ hr. 29.00 467.19
annually per 58 OPOs...................
-------------------------------
Totals.............................. 58.00 1,246.42
------------------------------------------------------------------------
Section 486.308 Designation of One OPO for Each Service Area
Section 486.308(d) states that if CMS changes the OPO designated
for an area, hospitals located in that area must enter into agreements
with the newly designated OPO or submit a request for a waiver in
accordance with paragraph (e) of this section within 30 days of notice
of the change in designation.
Section 486.308 (e) states that a may request and CMS might grant a
waiver permitting the hospital to have an agreement with a designated
OPO other than the OPO designated for the service area in which the
hospital is located. To qualify for a waiver, the hospital would have
to submit data to CMS establishing that--
(1) The waiver is expected to increase organ donations; and
(2) The waiver will ensure equitable treatment of patients listed
transplants within the service area served by the hospital's designated
OPO and within the service area served by the OPO with which the
hospital seeks to enter into an agreement.
The burden associated with this section is the time it would take a
hospital to request a waiver and to create an agreement with an OPO.
Based upon historical data, we estimate that
[[Page 31030]]
about 2 hospitals would request a waiver annually and that all of these
would need to enter into an agreement with the designated OPO.
Under 5 CFR 1320.3(c), a ``collection of information'' does not
include requirements imposed on fewer than ten entities. Therefore, the
final regulations of this section are not subject to the PRA.
Section 486.310 Changes in Control or Ownership or Service Area
Sections 486.310(a)(1)&(2) requires a designated OPO considering a
change in ownership or in its service area would have to notify CMS
before putting it into effect and would have to obtain prior CMS
approval. In the case of a service area change that results from a
change of ownership due to merger or consolidation, the OPOs would have
to resubmit the information required in an application for designation.
The OPO would have to provide information specific to the board
structure of the new organization, as well as operating budgets,
financial information, or other written documentation CMS determines to
be necessary for designation.
The burden associated with this section is the time it takes to
gather and submit the information CMS needs. We estimate that two OPOs
would be affected annually and that it will be the same amount of time
it would take a potential OPO requesting designation. While this
requirement is subject to the PRA, we believe it is exempt because
there are less than 10 respondents.
Section 486.312 De-Certification
Sections 486.312(a) states that if an OPO wishes to terminate its
agreement, it would have to send written notice of its intention with
the proposed effective date to CMS. In the case of voluntary
termination, Section 486.312(e) states that the OPO would have to give
prompt public notice of the date of de-certification, and such other
information as CMS may require, through publication in local newspapers
in the service area. In the case of involuntary termination, Section
486.312(e) states that CMS would provide public notice of the date of
de-certification.
The burden associated with these requirements is the time it would
take to send written notice to CMS and to publish pertinent information
in the local newspapers. We estimate that one OPO would be affected by
these requirements per year.
While this requirement is subject to the PRA, we believe it is
exempt because there are less than 10 respondents.
Section 486.314 Appeals
Section 486.314 states that if an OPO's de-certification is due to
involuntary termination or non-renewal of its agreement with CMS, the
OPO may appeal the de-certification on substantive and procedural
grounds. In its appeal, the OPO may request a reconsideration before
the Regional Administrator for the OPO's region. If the de-
certification is upheld by the Regional Administrator, the OPO may
request a hearing before a CMS Hearing Officer.
The burden associated with this provision is the time it will take
an OPO to request a reconsideration, and if necessary, a hearing, as
well as the time to prepare for both proceedings. However, we do not
expect to de-certify more than nine OPOs in a given year. As such, this
requirement is not subject to the PRA as stipulated under 5 CFR
1320.3(c).
Section 486.316 Re-Certification and Competition Processes
Section 486.316(a) requires OPOs to meet all 3 outcome measures
requirements at Sec. 486.318 and to be shown to be in substantial
compliance with the requirements for certification at Sec. 486.303,
including the conditions for coverage at Sec. 486.320 through Sec.
486.348. If all of these requirements are not met, the OPO is de-
certified. The de-certified OPO can appeal. If the de-certification is
upheld, the de-certified OPO cannot compete for its service area. If
the de-certification is overturned on appeal, the OPO is re-certified
and its service area is not opened for competition.
Section 486.316(d) states that for an OPO to compete for an open
service area, it must have meet the criteria for re-certification at
Sec. 486.316(a), donation rate and yield outcome measures at or above
100 percent of the mean national rate averaged over 4 years of the re-
certification cycle, and its donation rate must be at least 15
percentage points higher than the donation rate of the OPO currently
designated for the service area. Section 486.316(e) states that CMS
will determine which OPO to designate for an open service area based
upon (1) performance on the outcome measures at Sec. 486.318; (2)
relative success in meeting the process performance measures and other
conditions at Sec. Sec. 486.320 through 486.348; (3) contiguity to the
open service area; and (4) success in identifying and overcoming
barriers to donation within its own service area and the relevance of
those barriers to barriers in the open area. The competing OPO must
submit information and data that describe the barriers in its own
service area, how those barriers affected organ donation, what steps
the OPO took to overcome them, and the results.
The burden associated with this requirement is the time it would
take to create a document that contains the required information and
data related to the OPO's success in identifying and addressing the
barriers in its own service area and how they relate to the open
service area. We will refer to this documentation as a plan.
In the February 4, 2005 proposed rule, we proposed that it would
take approximately 16 hours to develop an acceptable plan to increase
organ donation. We believe that the document or plan that OPOs would be
required to prepare to compete under the final rule would require
approximately the same amount of resources. However, we received public
comments stating that 16 hours is underestimated. Thus, based on
further analysis of the multitude of tasks involved in meeting this
requirement, we are estimating it will take an average of 104 burden
hours to develop the plan needed to meet this requirement to compete
for an open service area.
In each of the 1996, 1998, and 2000 re-certification cycles,
approximately two to three OPOs failed the performance standards.
However, with the new outcome and process measures in this rule, we
believe that as many as 9 OPOs may be de-certified. All de-certified
OPOs will have the right to appeal their de-certifications. We believe
that 3 OPOs will have their de-certifications reversed at some point
during the appeal process. Therefore, 6 de-certifications will be
upheld and 6 service areas will be open for competition.
Based on historical data and our previous experience with the OPOs,
we would expect a total of 9 OPOs will want to compete for a new
service area and 3 of those OPOs may want to compete for more than one
service area. Thus, we believe there will be a total of 12 plans that
will need to be developed for the competition process.
We believe that developing each plan will require the collective
efforts of the QAPI director (Registered Nurse) (RN), organ procurement
coordinator (RN or social worker (SW)), medical director, OPO director,
and secretary would be expected in developing a plan. Assuming that it
would take these professionals 104 hours, instead of the proposed 16
hours, to develop such a plan, each competition would require 1,248
burden hours for all 9 OPOs to complete 12 plans and would cost all 9
OPOs $50,022. For the annual burden,
[[Page 31031]]
each of these figures needs to be divided by 4, since competition for
open service areas will typically occur every 4 years. Thus, the annual
burden hours for all 9 OPOs to prepare 12 plans would be 312 [1,248
divided by 4 = 312] and the annual cost estimate would be $12,505.50
[$50,022 divided by 4 = $12,505.50].
Per Competition and Annual Burden Hours and Costs Estimates for 9 Competing OPOs Preparing 12 Plans
----------------------------------------------------------------------------------------------------------------
Per Per
Hours/Est. salary/9 OPOs/12 plans competition competition Annual burden Annual cost
burden hours cost estimate hours estimate
----------------------------------------------------------------------------------------------------------------
1 QAPI director* (RN) @ $26.87/hr. x 30 hrs. x 9 360 $9,673.20 90 $2,418.30
competing OPOs for 12 plans....................
1 organ procurement coordinator (RN or SW)* @ 360 9,673.20 90 2,418.30
$26.87/hr. x 30 hrs. x 9 competing OPOs
(preparing 12 plans)...........................
1 OPO director** @ $50.48/hr. x 30 hrs. x 9 360 18,172.80 90 4,543.20
competing OPOs (preparing 12 plans)............
1 medical director ***@ $84.14/hr. x 12 hrs. x 9 144 12,116.16 36 3,029.04
competing OPOs (preparing 12 plans)............
1 secretary *@ $16.11/hr. x 2 hrs. x 9 competing 24 386.64 6 96.66
OPOs (preparing 12 plans)......................
---------------------------------------------------------------
Totals...................................... 1,248 50,022 312 12,505.50
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational Wages in the United States, July 2004; U.S. Department of Labor,
U.S, Bureau of Labor Statistics, August 2005.
** Per OPO Consortium survey mean salary for OPO Director is $105,000 annually ($50.48 per hour) as stated in
the proposed OPO rule (70 FR 6124).
*** http://swz.salary.com/salarywizard/layouthtmls/swzl_compresult_national_EX05000020.html.
The burden associated with this section is the time it takes to
gather the required information and data, evaluate it, and prepare a
plan to submit to CMS. While this requirement is subject to the PRA, we
believe it is exempt because there are less than 10 respondents.
Section 486.322 Condition: Relationships With Hospitals, Critical
Access Hospitals, and Tissue Banks
Section 486.322(a) requires an OPO to have a written agreement with
95 percent of the Medicare and Medicaid hospitals in its service area
that have both a ventilator and an operating room, that describes the
responsibilities of both the OPO and hospital in regard to the
requirements for hospitals in Sec. 482.45. The agreement would have to
address the requirement in Sec. 486.326 that the OPO would have to
maintain credentialing records for physicians who routinely recover
organs in hospitals under contract or arrangement with the OPO and
would have to assure that physicians and other practitioners who
recover organs in hospitals are qualified and trained.
The burden associated with this requirement is the time it will
take an OPO to enter into an agreement with a hospital. Currently, OPOs
are likely to have agreements with all hospitals in their service areas
because the hospital CoP for organ, tissue, and eye procurement, which
was effective August 21, 1998 (see section 482.45) requires all
hospitals to have agreements with their OPO.
However, many OPOs will need to rewrite their agreements. In this
case, we expect OPOs would develop a standard agreement that addresses
OPO and hospital responsibilities and defines ``imminent death'' and
``timely death'' and would ask each of these hospitals to sign the
standard agreement.
We believe an attorney would be key in this process. We estimate
that it would take an attorney 8 hours to draft a new standard
agreement that the OPO could present to each hospital. Thus, it would
require 464.00 annual burden hours at an estimated annual cost of
$23,200.00 for all 58 OPOs to have a new standard agreement drafted.
------------------------------------------------------------------------
Annual burden Annual cost
Hours/est. salary/ of OPOs hours estimate
------------------------------------------------------------------------
1 attorney x 8 hrs. x $50/hr. x 58 OPOs. 464.00 $23,200.00
-------------------------------
Totals.............................. 464.00 23,200.00
------------------------------------------------------------------------
U.S. Department of Labor and salary.com.
The average OPO has approximately 100 hospitals in its service
area. Based on past experience, we expect that between 50 percent and
67 percent of the hospitals in an OPO's service area would sign the
standard agreement with no changes. With few exceptions, the remainder
of hospitals would sign the agreements after a minimal amount of
negotiation. If 50 hospitals (50 percent of the 100 hospitals in an
OPO's service area) requested changes in the agreement before signing,
and it took the OPO's attorney 2 hours per agreement to make the
changes, it would require 116.00 burden hours at an estimated annual
cost of $5,000.00 per OPO.
------------------------------------------------------------------------
Annual burden Annual cost
Hours/est. salary/ of OPOs hours estimate
------------------------------------------------------------------------
1 attorney x 2 hrs. x $50/hr. x average 116.00 $5,000.00
of 50 hospitals/OPO....................
-------------------------------
Totals.............................. 116.00 5,000.00
------------------------------------------------------------------------
[[Page 31032]]
Thus, it would require 116.00 burden hours at an estimated annual
cost of $5,000.00 per OPO. It would require 6,728.00 burden hours at an
estimated cost of $290,000 for all of the 58 OPOs to make changes in
their agreements with hospitals.
------------------------------------------------------------------------
Annual burden Annual cost
Hours/est. salary/ of OPOs hours estimate
------------------------------------------------------------------------
1 attorney x 2 hrs. x $50/hr. x average 6,728.00 $290,000.00
of 50 hospitals/OPO x 58 OPOs..........
-------------------------------
Totals.............................. 6,728.00 290,000.00
------------------------------------------------------------------------
Section 486.324 Condition: Administration and Governing Body
Section 486.324 states that the OPO must have bylaws for its
board(s) that address conflicts of interest, length of terms, and
criteria for selecting and removing members.
A governing body or individual would have to have full legal
authority and responsibility for the management and provision of all
OPO services and would have to develop and implement policies and
procedures necessary for the effective administration of the OPO,
including services furnished under contract or arrangement, fiscal
operations, and continuous quality assessment and performance
improvement.
The OPO would have to have a procedure to address conflicts of
interest for the governing body or individual described above.
The burden associated with the above requirements is the time it
would take an OPO to create bylaws and to develop policies and
procedures necessary for the effective administration of the OPO. While
this requirement is subject to the PRA, we believe it is exempt as it
is usual and customary business practice to have such bylaws, policies,
and procedures.
Section 486.326 Condition: Human Resources
Section 486.326(a)(2) requires the OPO to have a written policy
that addresses conflicts of interest for the OPO's director, medical
director, and senior management, and procurement coordinators.
Section 486.326(a)(3) states that an OPO must maintain
credentialing records for physicians who routinely recover organs in
hospitals with which the OPO has an agreement.
While the burden associated with these requirements is subject to
the PRA, we believe these requirements reflect usual and customary
business practices and thus do not create any additional burden and are
exempt from the PRA.
Section 486.328 Condition: Reporting of Data
Section 486.328(a) requires the OPO to provide individually
identifiable, hospital-specific organ donation and transplantation data
to the OPTN and the SRTR, as directed by the Secretary. The OPO would
have to provide hospital-specific data directly to transplant
hospitals, annually. In addition, the OPO would be required to provide
individually identifiable, hospital-specific organ donation and
transplantation and other information to the Secretary, as requested.
Such data may include, but are not limited to:
(1) Number of hospital deaths;
(2) Results of death record reviews;
(3) Number and timeliness of referral calls from hospitals;
(4) Potential donor denominator (as defined in 486.302);
(5) Data related to non-recovery of organs,
(6) Data about consents for donation;
(7) Number of donors;
(8) Number of organs recovered (by type of organ); and
(9) Number of organs transplanted (by type of organ).
Sections 486.328(c) & (d) require potential donor data reported to
the OPTN to be used for OPO re-certification would have to include data
for all deaths that occurred in hospitals in the OPO's service area,
unless a hospital has a waiver to work with a different OPO. If an OPO
determines through death record review or other means that the
potential donor denominator data it reported to the OPTN was incorrect,
it must report the corrected data to the OPTN.
The burden associated with these requirements is the time it would
take the OPOs to report certain information. In this section, we
proposed that this would take no more than 4 hours per OPO per year, or
a national total of 236 hours. Based on comments, we are increasing
this figure to 12 hours per OPO per year.
------------------------------------------------------------------------
Annual burden Annual cost
Hours/est. salary/ of OPOs hours estimate
------------------------------------------------------------------------
1 data entry person @ $19.25/hr. x 12 696.00 $13,398.00
hrs. annually per 58 OPOs..............
-------------------------------
Totals.............................. 696.00 13,398.00
------------------------------------------------------------------------
In addition, although it appears this requirement has the potential
to add a significant new reporting burden, OPOs are required as a
condition of their membership in the OPTN to report a large amount of
data to the OPTN (which, in turn, provides the data to the SRTR for
analysis). For example, the cadaver donor registration form, (OMB
approved 0915-0157), OPOs are required to complete for each
donor contains more than 300 data elements. In addition, 42 CFR
121.11(b)(2) requires OPOs and transplant hospitals to submit
information about transplant candidates, transplant recipients, organ
donors, transplant program costs and performance, and ``other
information that the Secretary deems appropriate.'' Thus, most
information needed by the OPTN, the SRTR or the Department is already
being reported by OPOs.
We believe that almost any OPO data needed by CMS or other agencies
within the Department could be obtained from the OPTN or the SRTR. We
are including this provision only to give CMS and other agencies the
flexibility to request data from OPOs in the event that needed data
cannot be obtained expeditiously from the OPTN or the SRTR. We would
not request data from
[[Page 31033]]
OPOs if the data were readily available from other sources.
Section 486.330 Condition: Information Management
Section 486.330 requires OPOs to include specific data elements in
their records and to maintain their records in a human readable and
reproducible paper or electronic format for 7 years. In support of
public comment, we now will require that these records be maintained in
electronic format. Additionally, we finalized the proposed requirement
that these records be maintained for 7 years instead of 5 years.
We do not anticipate a significant burden associated with this
requirement since we believe all OPOs are using computer systems due to
the OPTN requirements. Additionally, because the final rule governing
the operation of the OPTN states that OPOs must maintain donor records
for 7 years, OPOs must already meet the proposed requirement.
Otherwise, all other elements in this information management CoC will
be finalized as proposed. While there is burden associated with these
requirements we believe it is exempt under 5 CFR 1320.3.
Section 486.342 Condition: Requesting Consent
Sections 486.342 paragraphs (a) and (b) requires that an OPO have a
written protocol to ensure that the individual(s) responsible for
making the donation decision are informed of their options to donate
organs and tissues (when the OPO is making a request for tissues) or to
decline to donate. The OPO must provide to the individual(s)
responsible for making the donation decision, at a minimum, the
following:
(1) A list of the organs or tissues that may be recovered.
(2) The most likely uses for the donated organs or tissues.
(3) A description of the screening and recovery processes.
(4) Information about organizations that will recover, process, and
distribute the tissue.
(5) Information regarding access to and release of the donor's
medical records.
(6) An explanation of the impact the donation process will have on
burial arrangements and the appearance of the donor's body.
(7) Contact information for individual(s) with questions or
concerns.
(8) A copy of the signed consent form if a donation is made.
(b) If an OPO does not request consent to donation because a
potential donor consented to donation before his or her death in a
manner that satisfied applicable State law requirements in the
potential donor's State of residence, the OPO must provide information
about the donation to the family of the potential donor, as requested.
We believe that all OPOs currently have policies regarding informed
consent, so there would basically be no additional burden to them as
the policies are usual and customary business practice. Some OPOs might
have to add some information, which could minimally increase the time
it takes to inform the individual(s) making the donation decision. We
estimate that 10 percent of the 58 OPOs (that is, rounded to 6 OPOs)
may have to add information to adequately meet this requirement. This
requirement affects fewer than 10 OPOs that may need to make slight
adjustments to information to adequately meet this requirement.
Therefore, according to 5 CFR 1320.3(c), a ``collection of
information,'' the ICRs of this section are not subject to the PRA.
Section 486.344 Condition: Evaluation and Management of Potential
Donors and Organ Placement Recovery
Under this section, the OPO must have an effective written protocol
for donor evaluation and management and organ placement and recovery.
We have revised the proposed requirement that the OPO must
implement a system to ensure that the ``medical director or other
qualified physician'' is available to assist in the medical management
of a donor when the surgeon on call is unavailable. Instead, we have
lessened the potential burden by allowing a ``qualified physician or
other qualified individual'' to meet this requirement. Also, we have
removed reference to the term ``best'' practices in response to
commenters' suggestions. Otherwise, only minor editorial and regulatory
formatting changes have been made in this final rule.
We have finalized the proposed requirement that the OPO must
include documentation in the donor's record of all test results,
including blood type, prior to organ recovery. We are requiring that
prior to recovery of an organ for transplantation, the OPO must have
written documentation from the OPTN showing, at a minimum, the intended
recipient's position on the waiting list in relation to other suitable
candidates and the recipient's OPTN identification number and blood
type.
The burden associated with this finalized requirement is the same
as the proposed burden. It includes the time it would take to create
the protocols. We believe that good business practices would dictate
that an OPO have written protocols to address the requirements of this
section. Therefore, there would be no additional burden and we believe
this to be exempt from the PRA.
Section 486.346 Condition: Organ Preparation and Transport
We have finalized this COP with minor technical changes to the
regulatory language. These changes have resulted in no additional
associated burden.
The ICR in this section requires that the OPO develop and follow a
written protocol for packaging, labeling, handling and shipping of
organs in a manner that ensures their arrival without compromise to the
quality of the organ. The protocol would have to include procedures to
check the accuracy and integrity of labels prior to transport.
The burden associated with this requirement is the time it would
take to create the protocols. We believe that good business practices
would dictate that an OPO have written protocols that address the
requirements of this section. Therefore, there would be no additional
burden and we believe it is exempt from the PRA.
Section 486.348 Condition: Quality Assessment and Performance
Improvement (QAPI)
The ICRs under this section were published in the NPRM on February
4, 2005 and are being finalized in this rule. We require an OPO to
develop, implement, and maintain a comprehensive, data-driven quality
assessment and performance improvement (QAPI) program designed to
monitor and evaluate ongoing and overall performance of all donation
services, including services provided under contract or arrangement.
The burden associated with these requirements would be the time and
effort required to develop a QAPI program. While this burden is subject
to the PRA, we believe the collection requirements are exempt as
defined in 5 CFR 1320.3(b)(2), the time, effort, and financial
resources necessary to comply with a collection of information that
would be incurred by persons in the normal course of their activities
(for example, in compiling and maintaining business records) will be
excluded from the burden. We believe that a typical OPO would already
have an established QAPI as part of its usual and customary business
practices, thus, would not incur any associated burden.
[[Page 31034]]
If you comment on these information collection and record keeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Division of Regulations Development,
Attn.: Melissa Musotto, CMS-3064-F, Room C5-14-03, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Carolyn Lovett, CMS Desk Officer, CMS-3064-F, [email protected]. Fax (202)-395-6974.
V. Regulatory Impact Analysis
We have examined the impacts of this final rule as required by
Executive Order 12866 (September 1993, Regulatory Planning and Review)
and the Regulatory Flexibility Act (RFA) (September 19, 1980 Pub. L.
96-354). Section 1102(b) of the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4) and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more annually). This final rule is
an economically significant rule under Executive Order 12866.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, non-profit organizations, and units of local
government. Most hospitals and most other providers and suppliers are
small entities, either by non-profit status or by having revenues of $6
million to $29 million in any one year. For purposes of the RFA, all
OPOs are considered to be small entities. Individuals and States are
not included in the definition of a small entity.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
the purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 100 beds. No such hospitals are
significantly affected by this rule because none are either transplant
centers or among those normally targeted for intensive organ donation
efforts.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates may result in expenditure in any one
year by State, local or tribal governments, in the aggregate, or by the
private sector, of $100 million in 1995 dollars, or about $120 million
in 2006 dollars.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. This rule does not impose substantial direct requirement
costs on State or local governments and does not preempt State law or
have other federalism implications.
Section 701 of Public Law 106-505, which was passed by the Congress
in 2000, requires us to publish regulations with new OPO outcome
measures and to certify OPOs under those new measures by January 1,
2002. The new outcome and process performance measures must rely on
empirical evidence, obtained through reasonable efforts, of organ donor
potential and other related factors in each OPO's service area. The
regulations must include multiple outcome measures.
All 58 OPOs would be affected by the requirements in this final
rule to a greater or lesser degree. Many OPOs have already put into
practice many of the final rule requirements. Thus, while we do not
believe the requirements in this final rule will have a substantial
economic impact on a significant number of OPOs, we believe it is
desirable to inform the public of our projections of the likely effects
of this final rule on OPOs. It is important to note that since OPOs are
paid by the Medicare program on a cost basis, any additional costs that
exceed an OPO's annual revenues would be fully reimbursed by the
Medicare program.
Our projections are based largely on data and information provided
by the CMS OPO Coordinators. Each Coordinator is responsible for the
OPOs located in one of the four CMS Consortia areas (Midwest, West,
South, and Northeast). In some cases, no data were available for one or
more of the Consortia. However, OPO practices typically vary by size
and affiliation (hospital-based or independent), rather than by
geographic location. Since all types of OPOs are represented within
each Consortium, we feel confident that the practices and experiences
of the OPOs within two or three of the Consortia are representative of
all OPOs. Therefore, where data were not available for all four
Consortia, we based our projections on data from fewer than four.
The provisions of this final rule would have a limited economic
impact on hospitals. It is expected that improved OPO performance would
result from the rule and would increase organ donation and, therefore,
the number of organs available for transplantation. Most of the costs
of transplantation estimated later in this analysis fall upon
hospitals. However, transplant hospitals are reimbursed for performing
transplants, and donor hospitals are reimbursed by OPOs for the cost of
maintaining potential donors. Therefore, there are no negative economic
impacts on hospitals that would result from the rule.
Reason for This Regulation
Approximately 70 people receive an organ transplant every day.
However, another 16 die due to the lack of transplantable organs
(http://organdonor.org). OPOs play a critical role in securing
transplantable human organs for seriously ill patients suffering from
end-stage organ failure. In fact, OPO performance is one of the most
critical elements in the nation's organ transplantation system. An OPO
that is effective in procuring organs and delivering them safely to
transplant centers clearly will save more lives than an ineffective
one.
In passing the Organ Procurement Organization Certification Act of
2000, Pub. L. 106-505, Section 701, the Congress made certain findings
related to OPOs and the current re-certification process for OPOs.
These findings included:
a. Organ Procurement Organizations play an important role in
increasing organ donation.
b. The uncertainty that resulted from the Department of Health and
Human Services' current certification and re-certification process was
actually interfering with the OPOs' effectiveness in increasing the
level of organ donation.
c. The limitations noted in the DHHS' re-certification process
included:
i. Sole reliance on population-based measures of performance that
do not
[[Page 31035]]
take into consideration a particular population's organ donation
potential.
ii. No allowance for other outcome and process standards that may
more precisely reflect each OPO's performance and potential.
iii. Lack of a process to appeal for re-certification on either
procedural or substantive grounds to the Secretary of DHHS.
The Organ Procurement Organization Certification Act required that
the Secretary of DHHS promulgate regulations that incorporate certain
key requirements. Those requirements have been incorporated into this
final rule.
The Congress clearly wanted the Secretary to establish a
certification process that would decrease the uncertainty inherent in
the current CMS certification process and improve OPO performance. The
goal was to increase organ donation and the number of transplantable
organs available for persons experiencing organ failure. We believe
that this final rule establishes certification and competition
processes that will meet those goals.
1. Feasible Alternatives for Competition Among OPOs for Service Areas
This final rule allows OPOs to compete for another OPO's service
area if the incumbent OPO has been de-certified by CMS. OPOs meeting
certain criteria may compete for these OPO service areas at the end of
each 4-year certification cycle. The competing OPO must meet the
following criteria that is specified in Sec. 486.316: (1) the OPO's
performance on the donation rate outcome measure and yield outcome
measure is at or above 100 percent of the mean national rate averaged
over the 4 years of the re-certification cycle; and (2) the OPO's
donation rate is at least 15 percentage points higher than the donation
rate of the OPO currently designated for the service area.
OMB Circular A-4 recommends that agencies explore modifications of
some or all of a regulation's attributes or provisions to identify
appropriate alternatives. CMS believes that competition is important to
facilitate improvement in OPO performance.
Three levels of competition were considered. We have defined these
alternatives, some of which are also discussed in the preamble of the
proposed rule, as:
a. Full Competition. All OPO service areas would be open for
competition every 4 years. Every OPO that has met the conditions for
coverage would be eligible to compete for another OPO's service area.
b. Limited Competition. All OPO service areas would be open for
competition every 4 years. Only those OPOs that meet the conditions for
coverage, the outcome performance measure thresholds, and have at least
a 15 percent higher donation rate in their own service area compared to
the incumbent OPO would be allowed to compete for another OPO's service
area. The incumbent OPO would be allowed to compete for its own service
area unless it had been de-certified by CMS.
c. Restricted Competition. Competition between OPOs would be
allowed for the service areas of OPOs that had been de-certified by CMS
and for service areas of OPOs that did not meet the outcome performance
measure thresholds. The competing OPO would have met the conditions for
coverage and the outcome performance measure thresholds. The incumbent
OPO would not be allowed to compete.
In this final rule, CMS has attempted to strike a balance between
the costs of competition in terms of resource use and disruption of
normal business operations and the benefits of competition, namely the
ability of competition to improve performance and inspire innovative
activity.
Under this final rule, we would select an OPO to replace an
incumbent, de-certified OPO if, in our assessment, the OPO could
significantly increase organ donation within that service area. This
assessment would be based on the competing OPO's (1) performance on the
outcome measures at Sec. 486.318; (2) relative success in meeting the
process performance measures at Sec. Sec. 486.320 through 486.348; (3)
contiguity to the open service area: and (4) submission of
documentation detailing its success in identifying barriers to donation
within its own service area. The competing OPO would have to submit
information and data that describe the barriers in its service area,
how they affected organ donation, what steps the OPO took to overcome
them, and the results.
Although these criteria are more objective than those contained in
the proposed rule, they will still give us the flexibility to exercise
reasonable judgment in choosing between competing OPOs. When comparing
competing OPOs, we will first consider each OPO's performance on the
outcome measures and the degree to which the top-performing OPO's
performance on the outcome measures exceeds the performance of other
competitors. Although we may view small variations as relatively
meaningless, if one OPO performed significantly better than its
competitors on all three outcome measures, we will rank that OPO very
high.
We will also take into account each competitor's relative success
in meeting the process performance measures. By ``relative success,''
we mean that we will judge whether the OPO simply satisfied the
requirements necessary to meet the process performance measures or
whether the OPO exceeded the requirements. In addition, we will take
into consideration whether the competing OPO's service area is
contiguous to the open area.
We will also carefully assess each OPO's experience and success in
identifying and surmounting barriers to organ donation in its own
donation service area and the relevance of those barriers to the
barriers in the open service area. For this criterion, the competing
OPO would have to submit information and data that described the
barriers in its own service area, how they affected organ donation,
what steps the OPO took to overcome them (such as, hospital
development, training, or public education), and the results of the
OPO's efforts. Although all OPOs face obstacles to organ donation in
their donation service areas, the nature of the barriers and the degree
to which they interfere with organ donation vary widely throughout the
country.
When we select among competing OPOs, we will weight each of the
first, second, and fourth criteria equally. We will use the third
criterion, contiguity to the open area, as a deciding factor only if we
determine that two or more competing OPOs are equally competent to take
over an open area.
Many factors can affect organ donation rates. For example, a
service area might have a large elderly population, a low motor vehicle
accident rate, or a high incidence of diseases that are incompatible
with organ donation. Cultural, ethnic, or racial factors may also
affect organ donation rates. For example, if there is a large immigrant
population in a service area, there might be significant cultural and
language barriers to donation. Therefore, an OPO that is contemplating
whether to compete for an open service area might need to perform
significant research and data analysis to determine whether or not it
wants to compete for a particular open service area. Once this analysis
was completed, the OPO's staff would have to develop a document
detailing its success in identifying barriers to donation within its
own service area, as well as its success in developing and implementing
processes to overcome barriers.
We received comments on the proposed rule that were critical of our
cost analysis stating that we grossly
[[Page 31036]]
underestimated the cost of the new requirements. After further analysis
of the multitude of tasks involved in meeting these requirements, we
agree that the estimate of 16 hours is insufficient. We estimate that
it would take a competing OPO approximately 104 hours to evaluate
whether it wanted to compete for a particular open service area and, if
it decided to compete, to prepare and submit the required written
documentation to CMS to compete for the open service area. A competing
OPO would likely need to include at least the following steps in its
evaluation: collection of information and data for the potential new
service area, analyses of the data and assessment of the incumbent
OPO's service area, identification of the factors that affected the
incumbent's performance, analysis of the existing internal and external
barriers to increasing organ donation in the service area,
identification of the specific activities and interventions the
competing OPO will have to perform to increase organ donation, and
finally, preparation and submission of the required information and
data that describe the barriers the competing OPO faced in its own
service area, how those barriers affected organ donation, what steps it
took to overcome them, and the results.
We would generally expect that 5 OPO staff members would
participate in the evaluation and preparation and submission of the
required documentation: The QAPI Director, Procurement Coordinator,
Medical Director, OPO Director, and a secretary. We have estimated the
number of hours each staff person would need to spend developing an
acceptable plan, based on the activities listed above, and calculated
the cost using mean wage figures and added fringe benefit costs (see
table 1). The mean physician hourly wage per the U.S. Department of
Labor is $57.90 and in the proposed rule we used a rate of $60 per hour
or $125,000 annually. We received comment that wages for medical
directors are significantly higher. We are now using a median pay rate
that is unique to medical directors obtained from the salary.com Web
site, a source of salary survey data reported only by human resource
professionals.
Table 1.--OPO Staff Time Required To Compete for an Open Service Area
------------------------------------------------------------------------
Hours of
Staff person Hourly wage work Total cost
------------------------------------------------------------------------
QAPI Director (RN)............... * $26.87 30 $ 806.10
Procurement Coordinator (RN or * $26.87 30 $ 806.10
SW).............................
OPO Director..................... ** $50.48 30 $1514.40
Medical Director................. *** $84.14 12 $1009.68
Secretary........................ * $16.11 2 $ 32.22
Subtotal..................... ........... 104 $4168.50
Fringe Benefits: 30.8% total **** ........... $1855.34
compensation....................
Total Staff Costs............ ........... ........... $6023.84
------------------------------------------------------------------------
* National Compensation Survey: Occupational Wages in the United States,
July 2004; U.S. Department of Labor, U.S, Bureau of Labor Statistics,
August 2005.
** Per OPO Consortium survey mean salary for OPO Director is $105,000
annually ($50.48 per hour) as stated in the proposed OPO rule (70 FR
6124).
*** http://swz.salary.com/salarywizard/layouthtmls/swzl_compresult_national_EX05000020.html.
**** Employer Costs for Employee Compensation, a Bureau of Labor
Statistics compensation measure, Table 28, September 2005 data. (http://www.bls.gov/ncs/ect/home.htm.)
The cost of evaluating whether or not to compete for an open
service area and preparing and submitting the required documentation to
CMS is estimated to be $6,023.84 for each plan.
Full Competition Under Existing Regulations
Under the current conditions for coverage for OPOs, there was full
competition for each service area at the end of each re-certification
cycle (42 CFR 486.316). OPOs that did not meet the performance
standards were de-certified and were not able to compete. Therefore,
only OPOs that met the performance standards were permitted to compete
for service areas. The full competition alternative we considered is
described as alternative (a) above in which all OPOs who meet the
conditions for coverage would be allowed to compete for any of the OPO
service areas.
Benefits of this approach: All other things being equal, greater
competition between OPOs should improve performance. If an OPO knows
that it is in danger of losing its service area during the re-
certification process, it should have an incentive to perform well.
This incentive would likely cause some OPOs to develop new, innovative
practices.
Costs of this approach: As explained above, the process of
competing for a service area involves the expenditure of resources. We
estimate that an OPO will expend $6,023.84 to compete for an open
service area. We analyzed the data that is currently available on the
OPOs' performance. If the criteria in the final rule were applied to
this data, we estimate that 9 OPOs would be de-certified. Based on this
data and our prior experience with the OPOs, we believe this is a good
estimate of how many OPOs would be de-certified using the criteria in
this final rule. Based upon our previous experience, we estimate that 6
of those OPOs will either appeal and have their de-certifications
upheld or will chose not to appeal their de-certifications. Based upon
historical data and our previous experience with the OPOs, of the 52
(the remaining 49 OPOs and the 3 OPO that had their de-certifications
reversed), there may be 26 OPOs that would either elect to compete for
other service areas or would have to defend their service area in a
competition. Each of the 26 OPOs would have to develop and submit the
documentation required to compete for the open service area. Some
service areas may have more that one competing OPO and others might
have only one. Since each competition would require at least 2 plans
(one from the incumbent OPO and one from a competing OPO), we estimate
that the OPOs would have to prepare and submit at least 52 plans to
CMS. The cost to these 26 OPOs would be 52 x $6,023.84 or $313,239.68.
Full competition is an adversarial process. This might adversely affect
the current collaborative atmosphere that exists between the OPOs.
Finally, full competition provides an opportunity for a minimally
effective OPO to take over a failing OPO. Depending upon which OPOs
competed for a particular service area, however,
[[Page 31037]]
there is no guarantee that a winning OPO would have more than the
minimum requirements to be re-certified, and thus the winning OPO might
be unable to improve donation in the service area. Therefore, we did
not propose that OPO service areas be opened to competition from all
OPOs.
Limited Competition
Under this option, all OPO service areas would be open to
competition as under the full competition option; however, only those
OPOs that met specific criteria would be allowed to compete for another
OPO's s ervice area.
The specific criteria used to designate which OPOs would be
eligible to compete for another OPO's service area would ensure that
the competition was limited to OPOs that had demonstrated above average
performance and that OPOs permitted to compete for open service areas
would be measurably superior to the incumbent OPOs.
Benefits of this approach: The intent of establishing competition
between the OPOs is to improve the overall performance of OPOs by
allowing above average OPOs to take over the service areas of poorly or
marginally performing OPOs, and to allow OPOs to bid for areas in which
they have the potential to significantly outperform the incumbent OPO.
The intent is not to have OPOs competing against one another when there
are only marginal differences between the OPOs. Therefore, we believe
the specific criteria would have to establish a measurable
differential. Costs of this approach: Although limited competition
would require fewer resources from OPOs overall, the competitive
activities would require resources from OPOs that decide to compete for
an open service area in the amount of $6,023.84 per OPO for competition
(see Table 1). Based upon the above discussion, we estimate that 9 OPOs
would be de-certified at the end of the 4 year certification cycle. We
believe that 3 would have their de-certifications reversed on appeal
and 6 would either have their de-certifications upheld on appeal or
chose not to appeal. Thus, there would be 6 open service areas. We
expect that at least one OPO would compete for each newly open service
area. Based upon both historical data and our previous experience with
the OPOs, of the 29 top performing OPOs eligible to compete, there
might be up to 9 OPOs that would elect to compete for other service
areas. Of those 9 OPOs, we estimate that 3 would elect to compete for
more than one service area. Thus, 12 plans would need to be developed
and submitted to CMS. The cost of developing these plans to compete is
estimated to be $72,286.08 (or 12 x $6,023.84). Although fewer OPOs
would be involved with limited competition, it would still be an
adversarial process. We anticipate that most OPOs would soon realize
who their potential competitors were and this could adversely affect
the current collaborative atmosphere that exists between many of the
OPOs. Although this effect would be to a lesser extent than with full
competition, the collaborative atmosphere between some OPOs may be
adversely affected by limited competition.
Thus, limited competition offers the advantage of having a better
performing OPO take over the service area of an incumbent OPO that is
not performing as well. It also offers the advantage of setting
specific criteria to ensure that the better performing OPO has the
expertise to increase organ donation in another service area. This
should result in increased organ donation in the competed service area.
Further, while limited competition has disadvantages, those
disadvantages can be minimized.
Restricted Competition
Under this option, the only competition allowed between OPOs would
be for the service areas of OPOs that had been de-certified by CMS.
However, the competition would still be limited to OPOs that met
specific criteria. The specific criteria would need to ensure that the
competing OPOs were performing at a higher level than minimally
performing OPOs. The intent would be to have an OPO that is performing
measurably better than the de-certified OPO take over the service area.
Benefits of this approach: Limiting competition in this way would
restrict competition to areas in which the expectation of significant
improvement in service could be met. In addition, fewer resources would
be diverted from organ procurement itself to the competitive process.
Costs of this approach: Clearly, restricted competition would
severely limit the competition between OPOs. Only service areas of de-
certified OPOs would be opened for competition. We estimate that 9 OPOs
may be de-certified at the end of the 4-year certification cycle and 6
would have their de-certifications upheld on appeal or would choose not
to appeal. Based upon our prior experience with the OPOs and historical
data, we estimate that there are 9 OPOs that would want to compete for
open service areas. We estimate that there would be at least one
competitor for each open service area and that 3 of the OPOs would
choose to compete for more than one service area. Thus, we estimate
that 9 plans would be prepared and submitted to CMS for the
competition. The cost of developing these plans to compete is estimated
to be 9 x $6,023.84 or $54,214.56. The service areas of minimally
performing OPOs (that is, OPOs that met the requirements for re-
certification but were not top performers) would not be opened for
competition from OPOs that had performed measurably better. Therefore,
restricted competition could not improve organ donation in service
areas of minimally performing OPOs.
2. Competition for Open Service Areas Under the Final Rule
Our method for competing the open service areas of de-certified
OPOs is a modified limited competition, as we feel this option best
balances the benefits and costs of the competitive process. We will not
allow a de-certified OPO to compete. The competition would be limited
to OPOs that met the requirements for re-certification in Sec.
486.316(a), and that had donation rate and yield outcome measures at or
above 100 percent of the mean nation rate averaged over the 4 years of
the re-certification cycle and had a donation rate that is at least 15
percentage points higher than the OPO that is currently designated for
the open service area. We would select an OPO for the service area
based on its success in meeting the outcome and process performance
measures, as well as the competing OPO's contiguity with the open
service area and its submission of information and data that describes
the barriers in its own service area, how they affected organ donation,
what steps the OPO took to overcome them, and the results.
We are limiting competition to OPOs that have performed measurably
better than the de-certified OPO. We believe such higher performing
OPOs would have the expertise to take over such an OPO's service area
and improve organ donation. We estimate that 9 OPOs would be de-
certified on the basis of the criteria at Sec. 486.316(a) (See also
Sec. Sec. 486.303, 486.312, and 486.318). We also estimate that 3 of
those OPOs would have their de-certifications reversed during the
appeals process. This would mean that potentially 6 service areas would
be open for competition. The number of OPOs allowed to compete is
restricted to those that meet the criteria at Sec. 486.316 (c) which
means perhaps less than half of the remaining 52 OPOs would be allowed
to compete. We estimate that 9 OPOs that meet the criteria will elect
to compete for the 6 de-certified OPOs'
[[Page 31038]]
service areas and that 3 of those OPOs will elect to compete for more
than one open service area. This means that 12 plans would need to be
developed by OPOs in order to compete. The cost of these 12 plans would
be 12 x $6,023.84 or $72,286.08. OPOs will be required to declare
whether they intend to compete for another service area very early in
the process. If no OPO plans to apply for an open service area, Sec.
486.316(f) states that CMS may select a single OPO to take over the
entire service area or may adjust the service area boundaries of two or
more OPOs to incorporate the open service area. CMS will base its
decision on the same criteria used to determine which OPOs may compete
for open service areas at Sec. 486.316(c). Our preferred competition
process would require fewer resources from the OPOs overall than full
competition, ensure timely completion of the competitive process, and
minimize disruption to operations in service areas.
Cost-Effectiveness and Cost-Benefit Analysis of Option Chosen
Our criteria for selecting a competing OPO are success in meeting
the Sec. 486.316(a) re-certification criteria, having a donation rate
outcome measure and yield measures at or above 100 percent of the mean
national rate averaged over the 4 years of the re-certification cycle,
and a donation rate that is at least 15 percentage points higher than
the donation rate of the OPO currently designated for the open service
area. We estimate that the overall plan development cost of the
modified limited competition option would total $72,286.08 across all
the OPOs once every 4 years. If we divide this figure by 4 to arrive at
an annual dollar figure, the yearly cost would be $18,071.52. We hope
to see a benefit in terms of increased organ donation by as much as 3
percent per year, with up to a 15 percent increase over the new 4-year
certification period in the new service area. Since the competing OPO
would have at least a 15 percent higher rate of donation in its own
service area, the expectation would be that this higher level of
effectiveness would be transferred over to the newly acquired service
area.
Under the statute and current OPO regulations, OPOs must be members
of and abide by the rules of the OPTN (as defined in Sec. 486.320);
therefore, there is no additional burden associated with this
condition. This rule requires that OPOs make available to CMS
documentation verifying that the OPO meets the provisions of Sec.
486.306 regarding service area location and characteristics to include
specific information. We believe that it would take an OPO an average
of 1 hour (\1/2\ hour of organ procurement coordinator time and \1/2\
hour of secretarial time) annually to make the information available.
Using pay rates of $26.87 for the organ procurement coordinator and
$16.11 for the secretary, the cost of 58 OPOs making the information
available would be $1,246.42.
Current OPO regulations require OPOs to have a board of directors
or an advisory board with a specific membership composition. This final
rule would require OPOs to have bylaws to address potential conflicts
of interest, length of terms, and criteria for selection and removal of
board members. It requires a governing body to have full legal
authority and responsibility for management and provision of all OPO
services, including development and implementation of policies and
procedures for administration of the OPO.
The economic impact on OPOs that do not have bylaws for their
boards addressing conflicts of interest, length of terms, and criteria
for selection and removal of board members would be the cost of
developing such bylaws. The extent of the impact would depend on the
process used to develop the bylaws. For example, at some OPOs, it is
likely an executive committee of the board would develop bylaws for
approval by the entire board. This process would result in little or no
cost to the OPO because the bylaws would be developed by unpaid board
members. However, other OPOs might include the OPO director in the
development of the bylaws. In this case, there would be a cost to the
OPO, based on the number of hours needed to develop the bylaws and the
director's salary. We do not expect that development of bylaws would
take more than a few hours, since information and advice regarding
development of bylaws would be available from OPOs that already have
bylaws in place for their boards.
It appears that about 70 percent of OPOs do not have bylaws for
their boards addressing conflicts of interest, and approximately 22
percent do not have bylaws addressing length of terms and criteria for
selection and removal of board members. This would mean that
approximately 41 OPOs would need to develop bylaws addressing conflicts
of interest, and approximately 13 would need to develop bylaws
addressing length of terms and criteria for selection and removal of
board members. Thus, under this final rule, OPOs would need to write 54
sets of bylaws for their boards of directors.
In one CMS Consortium, OPO Directors' salaries range from
approximately $80,000 to more than $130,000. To estimate the economic
impact, we assumed that all OPOs would choose to have their directors
participate in developing bylaws for their boards, and that the
development of each set of bylaws would take 8 hours of an OPO
director's time. If every director made $105,000 per year ($50.48 per
hour), it would cost an OPO $403.84 to develop a set of bylaws, for a
total of $21,807.36 to develop 54 sets of bylaws. We expect that most,
if not all, OPOs currently have an individual or governing body legally
responsible for management and provision of OPO services. Therefore, we
do not expect that there would be a cost to OPOs to implement this
provision of the regulation.
It is extremely difficult to quantify the costs for OPOs of meeting
the requirements for human resources. The human resources condition
requires every OPO to have a medical director, although it does not
specify that the medical director must be full time. We believe all
OPOs have medical directors, because the OPTN standards state that OPOs
must have medical directors who are licensed physicians and who are
responsible for medical and clinical activities of the OPO. However,
our final rule requires the medical director to be involved in the day-
to-day operations of the OPO because he or she would be responsible for
implementation of protocols for donor evaluation and management and
organ placement and recovery, as well as assisting in management of
donor cases if the surgeon on call were unavailable.
We believe that nearly all OPOs have a full-time medical director
or one or more part-time directors whose responsibilities include
implementation of protocols for donor evaluation and management and
organ placement and recovery and who assist in the management of donor
cases if the surgeon on call is unavailable. These OPOs would already
meet the requirements of the final rule. In fact, we believe that every
OPO in two of the CMS Consortia already fully meet this proposed
requirement. However, in a very small number of OPOs, medical directors
are not actively engaged in OPO operations; their participation may be
limited to consulting and attending board meetings.
It is difficult to quantify the cost to these few OPOs of meeting
the proposed requirement because the cost to an individual OPO would be
dependent on whether the OPO needed to hire a full-time medical
director, hire one or more
[[Page 31039]]
additional part-time medical directors, or increase the hours of an
existing medical director, and to what extent. Furthermore, salaries of
medical directors vary widely. Some local transplant surgeons who serve
as part-time OPO medical directors do not accept a salary for the
services they provide to the OPO; other part-time medical directors are
paid up to $100,000 per year. A full-time medical director may be paid
less than $100,000 or as much as $250,000 annually. As explained
earlier in this regulatory impact analysis, we are using an annual
salary of $175,011 (or $84.14 per hour) for OPO medical directors.
To estimate the economic impact of the medical director
requirement, we assumed that 10 percent of OPOs (6 OPOs) would need to
hire a part-time or full-time medical director or increase the hours of
an existing director and that, on average, each of these OPOs would
need a medical director for an additional 20 hours per week. If the
OPOs reimbursed the medical directors based on a rate of $175,011
annually, it would cost each of these 6 OPOs $87,505, and the total
economic impact would be $525,033.
We will require each OPO to maintain sufficient staff to carry on
essential OPO activities, such as answering hospital referral calls in
a timely manner and providing information and support to potential
donor families. Most OPOs have sufficient staffing to carry on
essential activities; to the extent that they do not, this rule
requires them to hire additional staff. However, the impact on
individual OPOs would vary, depending upon their situations. For
example, all OPOs in one CMS Consortium appear to have sufficient staff
to carry on essential activities. In another Consortium, all but two
OPOs appear to have sufficient staff. These two OPOs have added staff
based on comparative data from successful OPOs and from the AOPO Annual
Report have increased staffing over the past two years. However, in a
third Consortium, slightly more than half of the OPOs most likely would
need one or two procurement coordinators or other professionals in
order to have sufficient staff.
Most staff carrying on what would be considered ``essential''
activities (for example, procurement, hospital development, and
screening of referral calls) have a medical background. Procurement
coordinators are usually registered nurses (RNs), but sometimes they
are social workers. According to the U.S. Bureau of Labor Statistics
report published in August 2005 the 2004 median annual income of an RN
was $55,889.60 and the median annual income of medical and public
health social workers was $38,500. We have observed that procurement
coordinators generally earn about $40,000 to $45,000 to start. Hospital
development staff are sometimes RNs and sometimes individuals with
public relations backgrounds. In 2004, public relations managers had a
median annual income of $101,192. Sometimes OPOs' hospital development
and procurement staffs screen referral calls; however, OPOs may hire
other individuals to screen calls, such as medical and nursing students
or emergency medical technicians. In 2006, emergency medical
technicians have a median annual income of $24,600 according to
salary.com data.
We estimate that 10 percent of OPOs (6 OPOs) would need to add one
additional professional staff person and 5 percent (3 OPOs) would need
to hire 2 additional staff, for a total 12 additional staff. (This
estimate includes additional staff needed to meet all proposed
requirements except the QAPI requirements, which are discussed later in
this preamble.) If each staff person was paid $53,036 on average, the
total economic impact would be $636,432.
The human resources condition also would require OPOs to provide
the education, training, and supervision to their staffs necessary to
furnish required services. We have found that OPOs generally offer
three types of staff education and training, depending upon the size
and resources of the OPO: (1) On-the-job-training; (2) in-depth
training provided within the OPO, sometimes using a modular training
structure; and/or (3) classroom training that, in some cases, leads to
certification in procurement and transplantation.
Costs for training vary widely; however, we have found that good
staff training need not be expensive. OPOs provide no-cost training to
each other, in the form of on-site training sessions in hospital
development, as well as opportunities for staff details and
``shadowing'' of staff at high-performing OPOs. UNOS Regional Forums,
which are held once or twice per year in the 11 UNOS Regions, provide
opportunities for staff training at a low cost (for example, $75 per
day). Since the training is held within the UNOS Region, travel costs
are kept to a minimum. Two OPOs in one of the CMS Regional Consortia
have elected to use modular training with demonstration and examination
required to move to the next level. Training will be provided to all
new and existing OPO professional staff; the cost is estimated at
$5,000 per OPO. Some OPOs send their procurement coordinators for
training provided by the North American Transplant Coordinators
Organization, which costs approximately $1,000 to $1,500 per
coordinator.
If we estimate that 25 percent of OPOs (approximately 15 OPOs)
would need to provide additional education and training to their
professional staff in order to meet the requirements of the final rule,
and all 15 chose to use in-depth modular training within the OPO, the
cost to each OPO would be approximately $5,000, and the total cost for
all 15 OPOs would be $75,000.
The human resources condition would require an OPO to have a
written policy to address potential conflicts of interest for its
director, medical director, senior management, and procurement
coordinators. Although we expect that most OPOs have written policies
in place, we know that some OPOs do not. If an OPO had to develop such
a policy, it is likely it would be developed by the OPO director and
would take approximately 8 hours. If the director is paid $105,000
annually ($50.48 per hour), the cost to the OPO would be approximately
$404. If 25 percent of OPOs (approximately 15 OPOs) needed to develop
such bylaws, the total economic impact would be $6,058.
The human resources condition requires OPOs to maintain
credentialing records for physicians and other practitioners who
routinely recover organs in donor hospitals with which the OPO has
agreements and ensure that all physicians and other practitioners who
recover organs in hospitals are qualified and trained. We have been
told by OPOs that most, if not all, OPOs have some type of process to
ensure that physicians and other practitioners who recover organs are
qualified.
In most cases, organs are recovered by transplant surgeons from the
hospital that will perform the transplant or by physicians or
technicians employed by or under contract with OPOs. OPOs that do not
have a process to ensure that physicians and other practitioners are
qualified and trained would incur some costs to put a process into
place. An OPO would incur a cost for the staff time needed to request
and review credentialing records for transplant surgeons and to request
and review documentation of the qualifications of other recovery
personnel.
We estimate that requesting and reviewing a record would take no
more than 15 minutes. There are approximately 270 hospitals in the
United States with transplant programs. Thus, each of the 58 OPOs has,
on average, about five transplant hospitals
[[Page 31040]]
in its service area. If each hospital has 20 surgeons who recover
organs, an OPO would have to request and review approximately 100
records. Presuming this activity was performed by an OPO medical
director making $175,000 per year ($84.14 per hour), the cost to the
OPO for the medical director to spend 25 hours reviewing 100 records
would be $2,104. If we estimate that 10 percent of OPOs (approximately
6 OPOs) will need to perform this activity, the total cost would be
$12,621.
We have not assigned a cost for an OPO to request and review
records for physicians or other recovery personnel who work for or are
under contract to the OPO because we assume the OPO would perform those
activities in the normal course of business. Likewise, we have not
assigned a cost for activities associated with ensuring the
qualifications and training of physicians and other recovery personnel
from outside an OPO's service area. The time needed to verify
qualifications and training of these recovery personnel, who only
occasionally recover organs in an OPO's service area, would be minimal
and could be accomplished by contacting a transplant hospital to
confirm that a surgeon who will recover an organ at one of the OPO's
hospitals is credentialed and has privileges at the transplant
hospital.
The former OPO regulations required OPOs to maintain donor records
with specific data elements, although there was no requirement for how
long the records must be kept. The new information management condition
requires OPOs to include specific data elements in their records and
maintain their records for 7 years. We do not anticipate a significant
burden associated with this requirement because the final rule
governing the operation of the OPTN state that OPOs must maintain donor
records for 7 years; thus, we expect OPOs already meet the new
requirement.
The condition for reporting of data specifies that an OPO must
provide organ donation and transplantation data as requested by the
OPTN, the SRTR, and transplant hospitals. Additionally, the OPO is
required to provide data and other information directly to the
Department as requested by the Secretary. The former regulations
required only that OPOs report five performance data elements to us
annually and ``maintain and make available to CMS, the Comptroller
General, or their designees data that show the number of organs
procured and transplanted.''
Although it appears this requirement has the potential to add a
significant new reporting burden, OPOs already report a large amount of
data to the OPTN (which, in turn, provides the data to the SRTR for
analysis). For example, the cadaver donor registration form that OPOs
are required to complete for each donor contains more than 300 data
elements. Further, regulations governing the operation of the OPTN at
42 CFR 121.11(b)(2) require OPOs, as specified by the Secretary, to
submit data to the OPTN. Thus, most information needed by the OPTN, the
SRTR or the Secretary would already be reported by OPOs.
Although it is difficult to quantify the impact of the data
reporting requirement, as data would be requested on an as-needed
basis, we believe that almost any OPO data needed by us or other
agencies within the Department could be obtained from the OPTN or the
SRTR. We are including this provision only to give us and other
agencies the flexibility to request data from OPOs in the event that
needed data cannot be obtained expeditiously from the OPTN or the SRTR.
However, we can quantify the impact on OPOs of reporting the four
hospital-specific data elements they currently report voluntarily to
the OPTN (that is, referrals, medically suitable potential donors,
consents, and donors). All 58 OPOs have the capability of reporting
data to the OPTN electronically. HRSA estimates that reporting the four
data elements takes OPOs about 1 hour per month. If the data are
entered by a data coordinator earning $40,000 per year (approximately
$19.25 per hour), the cost to the OPO would be approximately $231
annually, for a total cost for all 58 OPOs of approximately $13,398.
We have included provisions in this rule for OPOs' relationships
with hospitals that do not appear in our current regulations for OPOs.
First, the condition would require an OPO to have written agreements
with 95 percent of the hospitals and critical access hospitals in the
OPO's service area (unless a hospital has a waiver to work with another
OPO) that have both a ventilator and an operating room. In addition,
the agreement must describe the responsibilities of both the OPO and
hospital or critical access hospital in regard to donation after
cardiac death, if the OPO has a protocol for donation after cardiac
death. We expect that OPOs already have agreements with all Medicare
and Medicaid participating hospitals in their service areas (unless a
hospital in the service area has a waiver to work with another OPO)
because the hospital and critical access hospital conditions of
participation for organ, tissue, and eye procurement, (see 42 CFR
482.45 and 485.643) require Medicare and Medicaid participating
hospitals and critical access hospitals to have an agreement with an
OPO. We have found that most agreements between OPOs and hospitals are
``generic'' in nature and do not specify the OPO and hospital roles in
the donation process. However, we are requiring OPOs to address the
responsibilities of both the OPO and the hospital in implementing Sec.
482.45 and Sec. 485.643 and include definitions for the terms
``imminent death'' and ``timely referral.''
Many OPOs will need to rewrite their agreements; however, we expect
OPOs would develop a standard agreement that addresses OPO and hospital
responsibilities and defines ``imminent death'' and ``timely death''
and would ask each of their hospitals to sign the standard agreement.
We also expect that OPOs will develop an agreement concerning the
responsibilities of both the OPO and the hospital concerning donation
after cardiac death for those hospitals that have a donation after
cardiac death protocol. We estimate that it would take an attorney 8
hours to draft a new standard agreement that the OPO could present to
each hospital. The average hourly wage for an attorney is $50 (Attorney
II; per salary.com); therefore, the cost to the OPO would be $400. The
total cost for all 58 OPOs to have a new standard agreement drafted
would be $23,200.
The average OPO has approximately 100 hospitals in its service
area. Based on past experience, we expect that between 50 percent and
67 percent of the hospitals in an OPO's service area would sign the
standard agreement with no changes. With few exceptions, the remainder
of the hospitals would sign the agreements after a minimal amount of
negotiation. If 50 hospitals (50 percent of the 100 hospitals in an
OPO's service area) requested changes in the agreement before signing,
and it took the OPO's attorney 2 hours per agreement to make the
changes, it would cost the average OPO $5,000. The total cost for all
OPOs to make changes in their agreements with hospitals would be
$290,000.
The condition also requires OPOs to offer annual designated
requestor training to hospital and critical access hospital staffs.
Although the hospital and critical access hospital conditions of
participation give OPOs the responsibility for offering or approving
designated requestor training for hospitals, very few OPOs have
actually provided a significant amount of training to their hospitals.
In fact, an August 2000 OIG report (Medicare Conditions of
Participation for Organ
[[Page 31041]]
Donation: An Early Assessment of the New Donation Rule) criticized OPOs
for not providing more designated requestor training.
Therefore, complying with this proposed requirement may add some
costs for an OPO that has provided little or no designated requestor
training if hospitals and critical access hospitals in its service area
respond positively to the OPO's offer to provide training. However, we
do not anticipate a significant economic impact because most hospitals
cannot spare staff to attend training in the entire consent process and
prefer to have their OPO handle most of the consent process.
Additionally, although many hospital staff act as designated requestors
in a supportive or collaborative role, we expect training for the
supportive or collaborative role to be significantly less extensive
(and therefore less costly) than training hospital staff for a
requestor role. For example, complete designated requestor training
might last for 4 to 8 hours, whereas supporter or collaborator training
might last for 2 hours or less. Designated requestor training also may
be provided through the use of a videotape. At least one OPO provides
designated requestor training over the Internet.
Generally, OPO hospital development staff (who are likely to earn
about $56,000 per year) provide designated requestor training in
hospitals. If the average training session lasts 4 hours and is given
at a hospital located 20 miles from the OPO, the total cost of a
training session (including salaries for two trainers for preparation,
travel, and training time; mileage; and preparing and printing training
packets) would be approximately $350. Based on our experience, we
expect that nationwide, approximately 75 hospitals might request
designated requestor training. Thus, the total economic impact would be
approximately $26,250, with an average of less than $453 per OPO.
OPOs will be required to have arrangements to cooperate with tissue
banks that have agreements with hospitals with which the OPO has
agreements. OPOs will be required to cooperate in screening and
referring potential tissue donors, obtaining informed consent on behalf
of tissue banks, and in the retrieval, processing, preservation,
storage, and distribution of tissues. Most OPOs already have
arrangements with the tissue banks in their service areas that address
such issues as screening and referral of tissue donors. We proposed
this requirement to address situations in which an OPO has refused to
have an arrangement with the tissue bank selected by the hospital.
There are approximately 300 tissue banks in the United States (166
conventional tissue banks and 134 eye banks) or approximately 5 tissue
banks per OPO service area. In many service areas, the OPO owns or is
affiliated with one of the tissue banks. In nearly all service areas,
OPOs have arrangements with all tissue banks that have agreements with
the hospitals in their service area. Based on our experience, we would
expect that fewer than 5 percent of tissue banks (15 tissue banks) that
do not have arrangements with an OPO would request an arrangement.
If an OPO and tissue bank elected to have a written agreement, we
would expect that the cost to the OPO of preparing the written
agreement and making any changes negotiated with the tissue bank would
be similar to the costs of preparing and making changes to a written
agreement between an OPO and a hospital (that is, a one-time cost to
the OPO of $400 for preparing an agreement, and an additional cost of
$100 to make changes). However, unlike hospital agreements that could
be standardized, we would assume that OPO/tissue bank agreements would
be individualized, since it is unlikely that more than one tissue bank
in an OPO's service area would request an arrangement. Therefore, the
total cost of preparing each agreement and making changes would be
$500, and the cost of preparing agreements with 15 tissue banks would
be $7,500.
For several reasons, we do not believe the requirement to have a
QAPI program will have a significant impact on a large number of OPOs.
First, most OPOs have a QAPI-type program (although not all programs
are sufficiently comprehensive to meet the requirements of the proposed
regulation). Second, AOPO is actively encouraging all OPOs to expand
and improve their programs; in fact, AOPO recently added the
development of a quality improvement program to their requirements for
AOPO accreditation, although the new requirements will be phased in
over 3 years. Third, in November 2001, AOPO surveyed OPOs to assess its
programs and found that 43 percent of the 35 OPOs that responded had
designated a staff person whose primary job responsibility was
coordinating and monitoring quality improvement. We have reason to
believe this percentage would be much higher if the survey were
performed today. Since AOPO conducted their survey, the majority of the
OPO community has embraced continuous quality improvement and taken
steps to integrate quality improvement into their core business
structure.
Additionally, there are numerous low-cost or no-cost resources
available to OPOs to develop QAPI programs, including the Breakthrough
Collaborative, assistance from CMS OPO Coordinators, and the AOPO
Quality Council. While we know that some OPOs will be impacted by the
new QAPI requirement, we do not expect the impact to be significant
because, at this time, all OPOs appear to be working toward developing
a comprehensive QAPI program.
We believe it is likely that approximately 20 percent of the 58
OPOs (12 OPOs) would need \1/2\ of a full-time equivalent (FTE)
position to bring their QAPI programs into compliance with the
requirement, and 15 percent (9 OPOs) would need 1 FTE. An OPO would be
likely to use an experienced individual from its hospital development
or procurement staff, and we estimate that the individual would be paid
approximately $56,000 annually. Thus, the cost to each of the 12 OPOs
that would need to add \1/2\ of an FTE would be approximately $28,000
per year, and the cost to each of the 9 OPOs that would need to add a
full FTE would be $56,000 per year, for a total cost of $840,000.
In addition, the new requirement for QAPI will require an OPO to
perform death record reviews at least monthly in every Medicare and
Medicaid hospital in its service area that has a Level I or Level II
trauma center or 150 or more beds, a ventilator, and an intensive care
unit (unless the hospital has a waiver to work with another OPO), with
the exception of rehabilitation or psychiatric hospitals. Based on our
experience, all OPOs routinely perform death record reviews in
hospitals they consider to have significant donor potential, but an
OPO's definition of ``significant donor potential'' may not encompass
as many hospitals as the requirement in this final rule. To the extent
that it does not, the OPO might need to increase staff hours to perform
the additional death record reviews. We estimate that approximately 20
percent of OPOs (12 OPOs) may need to add \1/2\ of an FTE in order to
expand the number of hospitals in which it performs death record
reviews or the number of hours needed to perform the death record
reviews at least monthly. It is likely the death record reviews would
be performed by RNs earning approximately $56,000 per year, thus the
cost to an OPO of adding \1/2\ of an FTE to perform death record
reviews would be approximately $28,000. The total economic impact for
all 12 OPOs would be $336,000.
[[Page 31042]]
The final rule requires that an OPO's QAPI program include a
written policy to address adverse events. We estimate that about 90
percent of OPOs (53 OPOs) would need to develop a written adverse event
policy and that development of the policy would require 8 staff hours.
We expect that the policy would be developed by professional staff,
including procurement coordinators, medical directors, and OPO
directors. We estimated an annual salary of $56,000 (approximately $27
per hour) for a procurement coordinator, $175,000 (approximately $60
per hour) for a medical director, and $105,000 (approximately $50 per
hour) for an OPO director, and we averaged the three hourly rates to
arrive at a cost of $54 per staff hour to develop an adverse event
policy. Therefore, the cost to one OPO of developing an adverse event
policy would be $432 for 8 hours of work. The total cost to all 53 OPOs
that would need to develop such policies would be $22,896.
The condition for requesting consent will have little impact on
OPOs. We believe all OPOs have policies for obtaining informed consent
and provide training to their staffs in the informed consent process.
Under the new conditions, some OPOs may have to broaden their informed
consent policies, but there will be little resultant economic impact.
The final rule would require OPOs to have written protocols for
donor evaluation and management and organ placement and recovery that
meet current standards of practice and are designed to maximize organ
quality and optimize the number of donors and the number of organs
recovered and transplanted per donor. Based on our experience, all OPOs
have written protocols for donor evaluation and management and organ
placement and recovery. The OPTN also has model protocols OPOs can
follow for evaluation and management of potential donors. Some OPOs
might need to update or change their protocols somewhat to meet the
proposed requirements, but we believe the cost to individual OPOs would
be negligible.
The condition for donor evaluation and management and organ
placement and recovery requires the medical director from the OPO to be
responsible for ensuring that the OPO has written protocols for donor
evaluation and management and for ensuring the implementation of the
protocols for each donor. Costs related to hiring or increasing the
hours of a medical director are discussed as part of the human
resources condition.
This condition also requires OPOs to establish protocols in
collaboration with transplant programs that define the roles and
responsibilities of the OPO and the transplant program. It appears that
all OPOs have some type of agreement or arrangement with the transplant
centers in their service areas, but often these agreements or
arrangements are informal in nature. Based on our experience, we expect
that developing a protocol with a transplant center as required under
the final rule would take approximately 10 hours. There are
approximately 824 transplant programs in the U.S.; therefore, each of
the 58 OPOs has approximately 14 transplant programs in its service
area. If it took an OPO medical director 10 hours to develop a protocol
with a transplant center and the medical director earned a salary of
$175,000 annually (approximately $84 per hour), it would cost an OPO
$840 for development of a single protocol and a total of $11,760 to
develop 14 protocols. (We assume that each protocol would be
individualized.) If we assume that 70 percent of the 58 OPOs (41 OPOs)
needed to develop protocols, the total economic impact would be
$482,160.
We foresee little economic impact from the proposed requirements in
the condition for organ preparation and transport. We believe nearly
all OPOs follow appropriate standards of practice for testing and
tissue typing of organs. Developing and following a protocol for
packaging, labeling, handling and shipping of organs can be done at
very little added cost. For example, the cost of additional supplies
for labeling inner and outer packaging of organs with the donor blood
type would be negligible.
Our estimates of the economic impact on OPOs to meet the
requirements in this final rule are as follows.
$1,246 to make service area information available.
$21,807 to develop bylaws for OPO boards.
$525,033 annually for medical director salaries.
$636,432 annually for additional staff to meet human
resources requirements.
$75,000 initial cost for staff training.
$6,058 to develop bylaws for OPO directors and other
management staff.
$12,621 to develop credentialing records for recovery
staff.
$13,398 annually to report data.
$23,200 to develop hospital agreements.
$290,000 to make changes to hospital agreements.
$26,250 for designated requestor training.
$7,500 to develop arrangements with tissue banks.
$840,000 annually for QAPI staff.
$336,000 annually to perform death record reviews.
$22,896 to develop an adverse event policy.
$482,160 to develop protocols with transplant centers.
$18,071 annual cost for competition (includes fringe
benefits).
Fringe benefit costs have been added to the annual cost for
competition, if fringe benefit costs were added to the remaining items
at a rate of 30.8 percent of total compensation we need to add in
$1,477,510. We have added fringe benefit costs in response to comments
that salary costs are not realistic when fringe benefits are omitted.
Summary of Direct Cost
The first-year economic impact of implementing the requirements in
this final rule would be $4,815,182, and the average first-year cost to
each of the 58 OPOs would be $83,000. This figure includes the fringe
benefits for all of the staff hours that were calculated.
Benefits
The primary economic impact of this final rule would lie with its
potential to increase organ donation. However, it is difficult to
predict precisely what that impact will be. In 1998, the year in which
the hospital conditions of participation went into effect, organ
donation increased by nearly 6 percent. During the first year of the
Organ Donation Breakthrough Collaborative (2003-2004), organ donation
increased by nearly 11 percent, and rates continue to increase. A 6
percent increase was seen in 2005, and the first quarter of 2006 shows
a 3 percent increase. We believe that the Breakthrough Collaborative
has been the driving force behind the most recent increases in organ
donation. Further, the Collaborative has helped achieve some of the
goals envisioned by this rule. Thus, we estimate that future growth in
organ donations as a result of this rule will be lower than immediate
past experience.
Absent the impact of this rule, the number of organ donors is
expected to remain stable in 2006. We estimate that by increasing OPOs'
efficiency and adherence to continuous quality improvement measures,
the provisions of this final rule could increase the number of organ
donors by an additional 1 to 3 percent per year, resulting in up to 180
additional donors in the regulation's first year. Based on 2000 data
for the average number of organs transplanted per donor (2.87), a
[[Page 31043]]
1 to 3 percent increase would result in approximately 172 to 517
additional transplants in the first year after implementation of the
regulation.
Transplants are performed both to save lives and to improve the
quality of recipients' lives. For end-stage renal disease patients,
dialysis is an alternative to transplantation for extended periods of
time. Nevertheless, physical health while on dialysis is significantly
impaired, and dialysis imposes major stresses and substantial
inconveniences in carrying out normal activities. Therefore, while for
most patients, kidney transplantation is not necessary for survival, it
significantly improves the quality of the transplant recipient's life.
For all other organs, a transplant is, in most cases, necessary for
survival.
Of the 17,219 transplants from deceased donors performed in 2000,
slightly less than half (46.7 percent) were kidney transplants. If this
regulation results in up to 571 additional transplants in the first
year, 241 lives (46.7 percent of 517 transplants) could be vastly
improved by kidney transplants and 276 lives (53.3 percent of 517)
could be both vastly improved and prolonged by transplantation of other
major organs.
The following reasoning was used to construct an estimate of the
benefits of this final rule. It is common, in cost benefit analysis, to
use a concept termed ``value of a statistical life'' (VSL) to estimate
in monetary terms the benefits from lives saved. Estimates of this
value can be derived from information on the preferences of individuals
for reduction in the risk of death, and their willingness to pay for
those reductions. For purposes of our cost benefit analysis, we have
used a VSL of $5,000,000. Applying this VSL, the social benefit from
276 non-renal transplants would be $1,380,000,000.
Since private payers generally base their payments on Medicare
payment rates, and since Medicare is the primary payor for the majority
of transplants, the discussion of costs of increased transplants will
use Medicare payment estimates. It is estimated that Medicare will pay
for 55.3 percent of all transplants occurring in 2006 based on
historical data. A 1 to 3 percent increase in transplants would result
in 95 to 286 additional Medicare transplants. Based on a median
increase of 2 percent, this would result in 161 additional kidney
transplants and 163 additional transplants of other organs nationally.
Kidney transplantation costs are offset by reductions in other
medical costs over time, primarily dialysis costs. The 2003 average per
person per year primary payor cost for dialysis patients was $63,723
while the cost for end-stage renal disease patients with a functioning
kidney graft was $15,357 (United States Renal Data System (USRDS): 2005
Annual Data Report: Atlas of End-Stage Renal Disease in the United
States pages 674 and 680). During the year of kidney transplantation,
the 2003 average per person per year primary payor cost was $95,567
according to the USRDS. Therefore, during the first two years of kidney
transplantation, the potential net health care cost savings would be
$16,522 per patient with annual savings of $48,366 thereafter. The
projected 2007 cost savings for the 2 percent increase in kidney
transplants is $13 million annually.
Below, based on Milliman projections, are the 5-year estimated
national costs resulting from a 2 percent increase in organ
transplants. The chart does not include heart-lung, kidney-pancreas,
and other multi-organ transplants, since complete data are not
available for these transplants. We believe the figures below
underestimate the economic impact of an increase in the number of
transplants by approximately 6 percent because multi-organ transplants
are not included.
We expect that the increase in organ transplants will be sustained
over the years so that every year this rule is in effect, it would
result in an increase of up to 517 (or more) additional transplants
being performed every year. It is difficult to project the total cost
savings that will result from this rule, but we do expect to see some
significant cost saving benefits.
In order to estimate the costs of providing transplantation and to
supplement the CMS payment data, we turned to the 2006 projections of
Milliman USA Consultants and Actuaries (authored by Nickolas J. Ortner,
and peer reviewed by Richared H. Hauboldt). In their report table 2
shows the ``Estimated U.S. Average 2006 First-Year Charges Per
Transplant'' broken out according to the type of organ transplanted,
including the estimated charges for the transplant and the outpatient
immunosuppressant medication during the initial year. The estimated
charges for the actual transplantation are broken into 3 categories:
procurement, hospital, and physician. In order to compare the Milliman
figures to what Medicare actually pays out, we compared 2004 CMS claims
data for procurement to the 2006 figures developed by Milliman. We
found that in 2004 Medicare paid between 31 and 72 percent of the
estimated 2006 Milliman charges for procurement. To allow for some
inflation and to be sure we are not underestimating the costs, we are
not applying a factor between 31 to 72 percent, but are estimating that
in 2006 Medicare would pay 80 percent of the 2006 Milliman estimated
charges for each of the additional transplants resulting from this
rule. The estimated first year total transplant costs of the 324
additional transplants (a 2 percent increase) resulting from this rule
is $87,066,414. Since the table below was based on 2006 data, the
figure of $85,125,338 was adjusted for inflation to obtain a 2007
projection for the estimated total first year transplant costs.
Estimated First Year Transplant Costs
----------------------------------------------------------------------------------------------------------------
Total transplant year costs Milliman Cases Total
----------------------------------------------------------------------------------------------------------------
Heart........................................................... 399,595 44 17,582,180
Liver........................................................... 352,874 91 32,229,159
Lung............................................................ 262,645 19 4,902,707
Pancreas........................................................ 266,433 9 2,309,086
Kidney.......................................................... 174,910 161 28,102,207
-----------------------------------------------
Total....................................................... 291,291 .............. 85,125,338
----------------------------------------------------------------------------------------------------------------
Note: The table above is derived from the 2006 Milliman estimates using a factor of 0.8. These costs include
procurement, hospital, physician, follow-up, immunosuppressive medications, and evaluation costs.
[[Page 31044]]
Transplant patients incur certain health care costs in the years
following transplantation. The Milliman data includes projections for
the immunosuppressant charges during the first year of transplantation
(which are included in the estimated first year figures above).
Milliman does not estimate transplant related charges after the first
year following the transplant ``due to a lack of data and a lack of
general interest in these values.'' Milliman drug charges are
calculated at 100 percent of 2006 average wholesale prices. In keeping
with section 303(c) of the Medicare Modernization Act, Medicare pays
for drugs at a lower rate of 106 percent of the average sales price.
Therefore, we adjusted the Milliman figures to arrive at a dollar
figure that reflects the estimated annual amount Medicare would
actually pay for immunosuppressant therapy after the first year of
transplantation.
On-Going Estimated Annual Immunosuppressive Drug Costs*
----------------------------------------------------------------------------------------------------------------
Milliman Cases Total
----------------------------------------------------------------------------------------------------------------
Heart........................................................... 15,675 44 689,700
Liver........................................................... 16,074 91 1,468,092
Lung............................................................ 16,245 19 303,240
Pancreas........................................................ 18,753 9 162,526
Kidney.......................................................... 15,390 161 2,472,660
-----------------------------------------------
Total....................................................... .............. .............. 3,631,055
----------------------------------------------------------------------------------------------------------------
*For a 2 percent increase in the number of transplanted patients.
We are projecting 5-year costs of the additional transplants
resulting from this rule by adding the first year costs and the
immunosuppressant therapy costs for years 2 through 5 as shown on the
table below. The cost for the immunosuppressant medication associated
with a 2 percent increase in organ transplantation is estimated to be
$3,631,055 annually starting with the second year after
transplantation.
Estimated 5-Year Costs for a 2 Percent Increase in Transplants
--------------------------------------------------------------------------------------------------------------------------------------------------------
2007 2008 2009 2010 2011 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inflation............................................... 1.02 1.04 1.03 1.03 1.03 ..............
Transplant Costs........................................ 87,066,414 90,438,902 93,515,336 96,439,428 99,623,603 467,083,683
Follow-Up Therapy For:
2007 Patients....................................... .............. 3,857,708 3,988,934 4,113,662 4,249,485 16,209,789
2008 Patients....................................... .............. .............. 3,988,934 4,113,662 4,249,485 12,352,081
2009 Patients....................................... .............. .............. .............. 4,113,662 4,249,485 8,363,147
2010 Patients....................................... .............. .............. .............. .............. 4,249,485 4,249,485
-----------------------------------------------------------------------------------------------
Total........................................... 87,066,414 94,296,610 101,493,204 108,780,415 116,621,542 508,258,184
--------------------------------------------------------------------------------------------------------------------------------------------------------
In our earlier discussion, we outlined the potential costs savings
of the additional 2 percent median increase in kidney transplants that
would be realized from the cost savings of dialysis. Other benefits of
organ transplants include:
Increase in years of life gained.
Improvements in quality of life, particularly for chronic
kidney disease patients.
Resumption of work/volunteerism/productivity for some
patients.
An increase in the number of taxpayers (patients who
return to work).
An increase in access to dialysis as more patients receive
kidney transplants.
In addition, we have calculated a benefit resulting from
this rule in terms of life years saved in the amount of up to $1.38
billion that is not included in this cost analysis.
The table below shows the estimated costs savings from the kidney
transplant patients who would no longer need dialysis.
Estimated Cost Savings--Renal
--------------------------------------------------------------------------------------------------------------------------------------------------------
2007 2008 2009 2010 2011 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Renal Savings For New Kidney Transplants................ 80,976 84,113 86,974 89,694 92,655 ..............
New Kidney Transplants.................................. 161 161 161 161 161 ..............
2007 Patients........................................... 13,010,200 13,514,145 13,973,852 14,410,795 14,886,601 ..............
2008 Patients........................................... .............. 13,514,145 13,973,852 14,410,795 14,886,601 ..............
2009 Patients........................................... .............. .............. 13,973,852 14,410,795 14,886,601
2010 Patients........................................... .............. .............. .............. 14,410,795 14,886,601 ..............
2011 Patients........................................... .............. .............. .............. .............. 14,886,601 ..............
-----------------------------------------------------------------------------------------------
Total Savings....................................... 13,010,200 27,028,291 41,921,556 57,643,179 74,433,005 214,036,230
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 31045]]
The tables below show the estimated costs savings from the non-
renal transplant patients who would no longer need end-of-life care. We
developed this table based upon data from the SRTR databank.
End-of-Life Savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
2007 2008 2009 2010 2011 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
End of Life Savings for:
2007 Patients........................................... 12,854,904 .............. .............. .............. .............. ..............
2008 Patients........................................... .............. 13,352,834 .............. .............. .............. ..............
2009 Patients........................................... .............. .............. 13,807,053 .............. .............. ..............
2010 Patients........................................... .............. .............. .............. 14,238,781 .............. ..............
2011 Patients........................................... .............. .............. .............. .............. 14,708,907 ..............
-----------------------------------------------------------------------------------------------
Total Savings....................................... 12,854,904 13,352,834 13,807,053 14,238,781 14,708,907 68,962,479
--------------------------------------------------------------------------------------------------------------------------------------------------------
The final step in our 5-year cost estimate requires that we
subtract the estimated cost savings from the costs of transplantation
shown above and add in the estimated costs of implementing the
processes required by this rule. The table below reflects a projected 2
percent increase in transplants and shows this calculation.
Total Net Costs Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
2007 2008 2009 2010 2011 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs of Additional Transplants*........................ 61,201,310 53,915,485 45,764,594 36,898,456 27,479,629 225,259,476
Costs of Complying with Final Rule...................... 4,815,182 3,887,394 4,081,764 4,285,852 4,500,144 21,570,336
-----------------------------------------------------------------------------------------------
Totals.............................................. 66,016,492 57,802,879 49,846,358 41,184,308 31,979,773 246,829,812
--------------------------------------------------------------------------------------------------------------------------------------------------------
*Includes both renal and non-renal transplants.
*Includes savings from dialysis and end-of-life care costs.
The total estimated impact of this rule, assuming a 2 percent
increase in organ transplants, is $66 million in the first year and
$247 million over 5 years. Assuming that Medicare transplants comprise
55.3 percent of all transplants, the estimated impact of this rule on
the Medicare program is $37 million in the first year and $136 million
over 5 years.
Formal Uncertainty Analysis
As discussed elsewhere in this preamble, our best estimate of the
impact of this final rule is a benefit of more than $1 billion each
year, based on the number of lives we expect would be saved and the
decrease in dialysis-associated costs by increasing organ donation and
transplantation due to increased OPO performance.
There are uncertainties associated with many of the projected costs
of this final rule. Many of the processes required by this final rule
have been put into place by OPOs in varying degrees. Current events, as
well as the publication of the proposed OPO conditions for coverage,
highlighted the need to make improvements in the organ procurement and
distribution process. OPOs have implemented processes over the last
year in response, and it is difficult to assess how close current OPO
practices have come to the requirements in this final rule. We have
estimated the additional human resources necessary to meet these
requirements based on data we received from the OPO coordinators and
our assessment of reasonable amounts of time required to complete
tasks. There is, however, uncertainty as to whether OPOs will implement
efficiencies that allow these requirements to be met by existing staff
or a by a smaller increase in full-time equivalents than we predicted.
We projected the cost of developing and updating agreements with
hospitals and arrangements with tissue banks. We are uncertain as to
whether OPOs would use templates for these documents that could serve
to reduce the costs.
This final rule implements a new competition process. We have
predicted and calculated the associated costs of this competition
process based on our estimation of the number of OPOs that would: be
de-certified; be qualified to compete; and choose to compete for a
service area. We used historical OPO data to devise a reasonable
estimate of the number of OPOs falling into each category. Although we
utilized the information currently available to us to make this
prediction, there is some uncertainty as to how many OPOs will actually
compete. Further, the OPOs have flexibility to decide how many
resources each would expend on the competition process, so there is
some uncertainty as to the cost of competition.
We calculated the costs of a one-time increase in the number of
transplanted organs that we predict would result from the
implementation of this rule. Over the last few years, there have been
significant increases in the number of procured organs due primarily to
the effort of the Breakthrough Collaborative described earlier in this
preamble. Due to these recent notable improvements in organ donation
rates, we are cautiously predicting a further increase of up to 3
percent. There is uncertainty as to what percent increase in
transplanted organs can be expected. While this rule is expected to
have a positive effect, there are a number of other factors that could
affect the donation rate such as the population demographics over the
years, natural disasters, technological advances, and donation
initiatives that may effect organ donation. There could also be
incremental increases in the number of organs procured over the next
several years that we did not predict.
We have calculated the costs associated with this rule using the
data and information we currently have available to formulate a
reasonable burden statement. There are uncertainties that may impact
the costs; however, we have performed an analysis of the predicted
costs and described the associated uncertainties.
In accordance with the provisions of Executive Order 12866, this
regulation
[[Page 31046]]
was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 413
Health facilities, Kidney diseases, Medicare, Puerto Rico,
Reporting and recordkeeping requirements.
42 CFR Part 441
Family planning, Grant programs-health, Infants and children,
Medicaid, Penalties, Reporting and recordkeeping requirements.
42 CFR Part 486
Health professionals, Medicare, Organ procurement, X-rays.
42 CFR Part 498
Administrative practice and procedure, Health facilities, Health
professions, Medicare, Reporting and recordkeeping requirements.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT
RATES FOR SKILLED NURSING FACILITIES
0
1. The authority citation for part 413 is revised to read as follows:
Authority: Secs. 1102, 1138(b), 1812(d), 1814(b), 1815, 1833(a),
(i), and (n), 1871, 1881, 1883, and 1886 of the Social Security Act
(42 U.S.C. 1302, 1320b-8(b), 1395d(d), 1395f(b), 1395g, 1395l(a),
(i), and (n), 1395hh, 1395rr, 1395tt, and 1395ww).
Sec. 413.200 [Amended]
0
2. Section 413.200(f) is amended by removing the phrase ``part 485,
subpart D'' and by adding ``part 486, subpart G'' in its place.
Sec. 413.202 [Amended]
0
3. Section 413.202 is amended by removing the phrase ``as defined in
Sec. 435.302 of this chapter'' and by adding ``as defined in Sec.
486.302 of this chapter'' in its place.
PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
SERVICES
0
1. The authority citation for part 441 continues to read as follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
Sec. 441.13 [Amended]
0
2. Section 441.13(c) is amended by removing the reference ``part 485,
subpart D'' and adding ``part 486 subpart G'' in its place.
PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED
BY SUPPLIERS
0
1. The authority citation for part 486 is revised to read as follows:
Authority: Secs. 1102, 1138, and 1871 of the Social Security Act
(42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public
Health Service Act (42 U.S.C 273).
0
2. Section 486.1 is amended by revising paragraph (a) to read as
follows:
Sec. 486.1 Basis and scope.
(a) Statutory basis. This part is based on the following sections
of the Act:
1102 and 1138(b), 1871 of the Social Security Act, section 371(b) of
the Public Health Service Act--for coverage of organ procurement
services.
1861(p)--for coverage of outpatient physical therapy services furnished
by physical therapists in independent practice.
1861(s) (3), (15), and (17)--for coverage of portable X-ray services.
* * * * *
0
3. Part 486 is amended by revising subpart G to read as follows:
Subpart G--Requirements for Certification and Designation and
Conditions for Coverage: Organ Procurement Organizations
Sec.
486.301 Basis and scope.
486.302 Definitions.
Requirements for Certification and Designation
486.303 Requirements for certification.
486.304 Requirements for designation.
486.306 OPO service area size designation and documentation
requirements.
486.308 Designation of one OPO for each service area.
486.309 Re-certification from August 1, 2006 through July 31, 2010.
486.310 Changes in control or ownership or service area.
Re-certification and De-certification
486.312 De-certification.
486.314 Appeals.
486.316 Re-certification and competition processes.
Organ Procurement Organization Outcome Requirements
486.318 Condition: Outcome measures.
Organ Procurement Organization Process Performance Measures
486.320 Condition: Participation in Organ Procurement and
Transplantation Network.
486.322 Condition: Relationships with hospitals, critical access
hospitals, and tissue banks.
486.324 Condition: Administration and governing body.
486.326 Condition: Human resources.
486.328 Condition: Reporting of data.
486.330 Condition: Information management.
486.342 Condition: Requesting consent.
486.344 Condition: Evaluation and management of potential donors and
organ placement and recovery.
486.346 Condition: Organ preparation and transport.
486.348 Condition: Quality assessment and performance improvement
(QAPI).
Subpart G--Requirements for Certification and Designation and
Conditions for Coverage: Organ Procurement Organizations
Sec. 486.301 Basis and scope.
(a) Statutory basis. (1) Section 1138(b) of the Act sets forth the
requirements that an organ procurement organization (OPO) must meet to
have its organ procurement services to hospitals covered under Medicare
and Medicaid. These include certification as a ``qualified'' OPO and
designation as the OPO for a particular service area.
(2) Section 371(b) of the Public Health Service Act sets forth the
requirements for certification and the functions that a qualified OPO
is expected to perform.
(3) Section 1102 of the Act authorizes the Secretary of Health and
Human Services to make and publish rules and regulations necessary to
the efficient administration of the functions that are assigned to the
Secretary under the Act.
(4) Section 1871 of the Act authorizes the Secretary to prescribe
regulations as may be necessary to carry out the administration of the
Medicare program under title XVIII.
(b) Scope. This subpart sets forth--
(1) The conditions and requirements that an OPO must meet;
(2) The procedures for certification and designation of OPOs; and
(3) The terms of the agreement with CMS and the basis for and the
effect of de-certification.
(4) The requirements for an OPO to be re-certified.
Sec. 486.302 Definitions.
As used in this subpart, the following definitions apply:
Adverse event means an untoward, undesirable, and usually
unanticipated event that causes death or serious injury or the risk
thereof. As applied to OPOs,
[[Page 31047]]
adverse events include but are not limited to transmission of disease
from a donor to a recipient, avoidable loss of a medically suitable
potential donor for whom consent for donation has been obtained, or
delivery to a transplant center of the wrong organ or an organ whose
blood type does not match the blood type of the intended recipient.
Agreement cycle refers to the time period of at least 4 years when
an agreement is in effect between CMS and an OPO.
Certification means a CMS determination that an OPO meets the
requirements for certification at Sec. 486.303.
Death record review means an assessment of the medical chart of a
deceased patient to evaluate potential for organ donation.
Decertification means a CMS determination that an OPO no longer
meets the requirements for certification at Sec. 486.303.
Designated requestor or effective requestor is an individual
(generally employed by a hospital), who is trained to handle or
participate in the donation consent process. The designated requestor
may request consent for donation from the family of a potential donor
or from the individual(s) responsible for making the donation decision
in circumstances permitted under State law, provide information about
donation to the family or decision-maker(s), or provide support to or
collaborate with the OPO in the donation consent process.
Designation means CMS assignment of a geographic service area to an
OPO. Once an OPO is certified and assigned a geographic service area,
organ procurement costs of the OPO are eligible for Medicare and
Medicaid payment under section 1138(b)(1)(F) of the Act.
Donation service area (DSA) means a geographical area of sufficient
size to ensure maximum effectiveness in the procurement and equitable
distribution of organs and that either includes an entire metropolitan
statistical area or does not include any part of such an area and that
meets the standards of this subpart.
Donor means a deceased individual from whom at least one
vascularized organ (heart, liver, lung, kidney, pancreas, or intestine)
is recovered for the purpose of transplantation.
Donor after cardiac death (DCD) means an individual who donates
after his or her heart has irreversibly stopped beating. A donor after
cardiac death may be termed a non-heartbeating or asystolic donor.
Donor document is any documented indication of an individual's
choice in regard to donation that meets the requirements of the
governing state law.
Eligible death for organ donation means the death of a patient 70
years old or younger, who ultimately is legally declared brain dead
according to hospital policy independent of family decision regarding
donation or availability of next-of-kin, independent of medical
examiner or coroner involvement in the case, and independent of local
acceptance criteria or transplant center practice, who exhibits none of
the following:
(1) Active infections (specific diagnoses).
(i) Bacterial:
(A) Tuberculosis.
(B) Gangrenous bowel or perforated bowel and/or intra-abdominal
sepsis.
(ii) Viral:
(A) HIV infection by serologic or molecular detection.
(B) Rabies.
(C) Reactive Hepatitis B Surface Antigen.
(D) Retroviral infections including HTLV I/II.
(E) Viral Encephalitis or Meningitis.
(F) Active Herpes simplex, varicella zoster, or cytomegalovirus
viremia or pneumonia.
(G) Acute Epstein Barr Virus (mononucleosis).
(H) West Nile Virus infection.
(I) Severe acute respiratory syndrome (SARS).
(iii) Fungal:
(A) Active infection with Cryptococcus, Aspergillus, Histoplasma,
Coccidioides.
(B) Active candidemia or invasive yeast infection.
(iv) Parasites: active infection with Trypanosoma cruzi (Chagas'),
Leishmania, Strongyloides, or Malaria (Plasmodium sp.).
(v) Prion: Creutzfeldt-Jacob Disease.
(2) General:
(i) Aplastic Anemia.
(ii) Agranulocytosis.
(iii) Extreme Immaturity (<500 grams or gestational age of <32
weeks).
(iv) Current malignant neoplasms except non-melanoma skin cancers
such as basal cell and squamous cell cancer and primary CNS tumors
without evident metastatic disease.
(v) Previous malignant neoplasms with current evident metastatic
disease.
(vi) A history of melanoma.
(vii) Hematologic malignancies: Leukemia, Hodgkin's Disease,
Lymphoma, Multiple Myeloma.
(viii) Multi-system organ failure (MSOF) due to overwhelming sepsis
or MSOF without sepsis defined as 3 or more systems in simultaneous
failure for a period of 24 hours or more without response to treatment
or resuscitation.
(ix) Active Fungal, Parasitic, viral, or Bacterial Meningitis or
encephalitis.
(3) The number of eligible deaths is the denominator for the
donation rate outcome performance measure as described at Sec.
486.318(a)(1).
Eligible donor means any donor that meets the eligible death
criteria. The number of eligible donors is the numerator of the
donation rate outcome performance measure.
Entire metropolitan statistical area means a metropolitan
statistical area (MSA), a consolidated metropolitan statistical area
(CMSA), or a primary metropolitan statistical area (PMSA) listed in the
State and Metropolitan Area Data Book published by the U.S. Bureau of
the Census. CMS does not recognize a CMSA as a metropolitan area for
the purposes of establishing a geographical area for an OPO.
Expected donation rate means the donation rate expected for an OPO
based on the national experience for OPOs serving similar hospitals and
donation service areas. This rate is adjusted for the following
hospital characteristics: Level I or Level II trauma center,
Metropolitan Statistical Area size, CMS Case Mix Index, total bed size,
number of intensive care unit (ICU) beds, primary service, presence of
a neurosurgery unit, and hospital control/ownership.
Observed donation rate is the number of donors meeting the
eligibility criteria per 100 deaths.
Open area means an OPO service area for which CMS has notified the
public that it is accepting applications for designation.
Organ means a human kidney, liver, heart, lung, pancreas, or
intestine (or multivisceral organs when transplanted at the same time
as an intestine).
Organ procurement organization (OPO) means an organization that
performs or coordinates the procurement, preservation, and transport of
organs and maintains a system for locating prospective recipients for
available organs.
Re-certification cycle means the 4-year cycle during which an OPO
is certified.
Standard criteria donor (SCD) means a donor that meets the
eligibility criteria for an eligible donor and does not meet the
criteria to be a donor after cardiac death or expanded criteria donor.
Transplant hospital means a hospital that provides organ
transplants and other medical and surgical specialty services required
for the care of transplant patients. There may be one or
[[Page 31048]]
more types of organ transplant centers operating within the same
transplant hospital.
Urgent need occurs when an OPO's noncompliance with one or more
conditions for coverage has caused, or is likely to cause, serious
injury, harm, impairment, or death to a potential or actual donor or an
organ recipient.
Requirements for Certification and Designation
Sec. 486.303 Requirements for certification.
In order to be certified as a qualified organ procurement
organization, an organ procurement organization must:
(a) Have received a grant under 42 U.S.C. 273(a) or have been
certified or re-certified by the Secretary within the previous 4 years
as being a qualified OPO.
(b) Be a non-profit entity that is exempt from Federal income
taxation under section 501 of the Internal Revenue Code of 1986.
(c) Have accounting and other fiscal procedures necessary to assure
the fiscal stability of the organization, including procedures to
obtain payment for kidneys and non-renal organs provided to transplant
hospitals.
(d) Have an agreement with CMS, as the Secretary's designated
representative, to be reimbursed under title XVIII for the procurement
of kidneys.
(e) Have been re-certified as an OPO under the Medicare program
from January 1, 2002 through December 31, 2005.
(f) Have procedures to obtain payment for non-renal organs provided
to transplant centers.
(g) Agree to enter into an agreement with any hospital or critical
access hospital in the OPO's service area, including a transplant
hospital that requests an agreement.
(h) Meet the conditions for coverage for organ procurement
organizations, which include both outcome and process performance
measures.
(i) Meet the provisions of titles XI, XVIII, and XIX of the Act,
section 371(b) of the Public Health Services Act, and any other
applicable Federal regulations.
Sec. 486.304 Requirements for designation.
(a) Designation is a condition for payment. Payment may be made
under the Medicare and Medicaid programs for organ procurement costs
attributable to payments made to an OPO by a hospital only if the OPO
has been designated by CMS as an OPO.
(b) An OPO must be certified as a qualified OPO by CMS under 42
U.S.C. 273(b) and Sec. 486.303 to be eligible for designation.
(c) An OPO must enter into an agreement with CMS in order for the
organ procurement costs attributable to the OPO to be reimbursed under
Medicare and Medicaid.
Sec. 486.306 OPO service area size designation and documentation
requirements.
(a) General documentation requirement. An OPO must make available
to CMS documentation verifying that the OPO meets the requirements of
paragraphs (b) through (d) of this section at the time of application
and throughout the period of its designation.
(b) Service area designation. The defined service area either
includes an entire metropolitan statistical area or a New England
county metropolitan statistical area as specified by the Director of
the Office of Management and Budget or does not include any part of
such an area.
(c) Service area location and characteristics. An OPO must define
and document a proposed service area's location through the following
information:
(1) The names of counties (or parishes in Louisiana) served or, if
the service area includes an entire State, the name of the State.
(2) Geographic boundaries of the service area.
(3) The number and the names of all hospitals and critical access
hospitals in the service area that have both a ventilator and an
operating room.
Sec. 486.308 Designation of one OPO for each service area.
(a) CMS designates only one OPO per service area. A service area is
open for competition when the OPO for the service area is de-certified
and all administrative appeals under Sec. 486.314 are exhausted.
(b) Designation periods--
(1) General. An OPO is normally designated for a 4-year agreement
cycle. The period may be shorter, for example, if an OPO has
voluntarily terminated its agreement with CMS and CMS selects a
successor OPO for the balance of the 4-year agreement cycle. In rare
situations, a designation period may be longer, for example, a
designation may be extended if additional time is needed to select a
successor OPO to an OPO that has been de-certified.
(2) Re-Certification. Re-certification must occur not more
frequently than once every 4 years.
(c) Unless CMS has granted a hospital a waiver under paragraphs
(d) through (f) of this section, the hospital must enter into an
agreement only with the OPO designated to serve the area in which the
hospital is located.
(d) If CMS changes the OPO designated for an area, hospitals
located in that area must enter into agreements with the newly
designated OPO or submit a request for a waiver in accordance with
paragraph (e) of this section within 30 days of notice of the change in
designation.
(e) A hospital may request and CMS may grant a waiver permitting
the hospital to have an agreement with a designated OPO other than the
OPO designated for the service area in which the hospital is located.
To qualify for a waiver, the hospital must submit data to CMS
establishing that--
(1) The waiver is expected to increase organ donations; and
(2) The waiver will ensure equitable treatment of patients listed
for transplants within the service area served by the hospital's
designated OPO and within the service area served by the OPO with which
the hospital seeks to enter into an agreement.
(f) In making a determination on waiver requests, CMS considers--
(1) Cost effectiveness;
(2) Improvements in quality;
(3) Changes in a hospital's designated OPO due to changes in the
definitions of metropolitan statistical areas, if applicable; and
(4) The length and continuity of a hospital's relationship with an
OPO other than the hospital's designated OPO.
(g) A hospital may continue to operate under its existing agreement
with an out-of-area OPO while CMS is processing the waiver request. If
a waiver request is denied, a hospital must enter into an agreement
with the designated OPO within 30 days of notification of the final
determination.
Sec. 486.309 Re-certification from August 1, 2006 through July 31,
2010.
An OPO will be considered to be re-certified for the period of
August 1, 2006 through July 31, 2010 if an OPO met the standards to be
a qualified OPO within a 4-year period ending December 31, 2001 and has
an agreement with the Secretary that is scheduled to terminate on July
31, 2006. Agreements based on the August 1, 2006 through July 31, 2010
re-certification cycle will end on January 31, 2011.
Sec. 486.310 Changes in control or ownership or service area.
(a) OPO requirements.
(1) A designated OPO considering a change in control (see Sec.
413.17(b)(3)) or
[[Page 31049]]
ownership or in its service area must notify CMS before putting it into
effect. This notification is required to ensure that the OPO, if
changed, will continue to satisfy Medicare and Medicaid requirements.
The merger of one OPO into another or the consolidation of one OPO with
another is considered a change in control or ownership.
(2) A designated OPO considering a change in its service area must
obtain prior CMS approval. In the case of a service area change that
results from a change of control or ownership due to merger or
consolidation, the OPOs must resubmit the information required in an
application for designation. The OPO must provide information specific
to the board structure of the new organization, as well as operating
budgets, financial information, and other written documentation CMS
determines to be necessary for designation.
(b) CMS requirements.
(1) If CMS finds that the OPO has changed to such an extent that it
no longer satisfies the requirements for OPO designation, CMS may de-
certify the OPO and declare the OPO's service area to be an open area.
An OPO may appeal such a de-certification as set forth in Sec.
486.314. The OPO's service area is not opened for competition until the
conclusion of the administrative appeals process.
(2) If CMS finds that the changed OPO continues to satisfy the
requirements for OPO designation, the period of designation of the
changed OPO is the remaining portion of the 4-year term of the OPO that
was reorganized. If more than one designated OPO is involved in the
reorganization, the remaining designation term is the longest of the
remaining periods unless CMS determines that a shorter period is in the
best interest of the Medicare and Medicaid programs. The changed OPO
must continue to meet the requirements for certification at Sec.
486.303 throughout the remaining period.
Re-Certification and De-Certification
Sec. 486.312 De-certification.
(a) Voluntary termination of agreement. If an OPO wishes to
terminate its agreement, the OPO must send CMS written notice of its
intention to terminate its agreement and the proposed effective date.
CMS may approve the proposed date, set a different date no later than 6
months after the proposed effective date, or set a date less than 6
months after the proposed effective date if it determines that a
different date would not disrupt services to the service area. If CMS
determines that a designated OPO has ceased to furnish organ
procurement services to its service area, the cessation of services is
deemed to constitute a voluntary termination by the OPO, effective on a
date determined by CMS. CMS will de-certify the OPO as of the effective
date of the voluntary termination.
(b) Involuntary termination of agreement. During the term of the
agreement, CMS may terminate an agreement with an OPO if the OPO no
longer meets the requirements for certification at Sec. 486.303. CMS
may also terminate an agreement immediately in cases of urgent need,
such as the discovery of unsound medical practices. CMS will de-certify
the OPO as of the effective date of the involuntary termination.
(c) Non-renewal of agreement. CMS will not voluntarily renew its
agreement with an OPO if the OPO fails to meet the requirements for
certification at Sec. 486.318, based on findings from the most recent
re-certification cycle, or the other requirements for certification at
Sec. 486.303. CMS will de-certify the OPO as of the ending date of the
agreement.
(d) Notice to OPO. Except in cases of urgent need, CMS gives
written notice of de-certification to an OPO at least 90 days before
the effective date of the de-certification. In cases of urgent need,
CMS gives written notice of de-certification to an OPO at least 3
calendar days prior to the effective date of the de-certification. The
notice of de-certification states the reasons for de-certification and
the effective date.
(e) Public notice. Once CMS approves the date for a voluntary
termination, the OPO must provide prompt public notice of the date of
de-certification and such other information as CMS may require through
publication in local newspapers in the service area. In the case of
involuntary termination or non-renewal of an agreement, CMS provides
public notice of the date of de-certification through publication in
local newspapers in the service area. No payment under titles XVIII or
XIX of the Act will be made with respect to organ procurement costs
attributable to the OPO on or after the effective date of de-
certification.
Sec. 486.314 Appeals.
If an OPO's de-certification is due to involuntary termination or
non-renewal of its agreement with CMS, the OPO may appeal the de-
certification on substantive and procedural grounds.
(a) Notice of initial determination. CMS mails notice to the OPO of
an initial de-certification determination. The notice contains the
reasons for the determination, the effect of the determination, and the
OPO's right to seek reconsideration.
(b) Reconsideration. (1) Filing request. If the OPO is dissatisfied
with the de-certification determination, it has 15 business days from
receipt of the notice of de-certification to seek reconsideration from
CMS. The request for reconsideration must state the issues or findings
of fact with which the OPO disagrees and the reasons for disagreement.
(2) An OPO must seek reconsideration before it is entitled to seek
a hearing before a hearing officer. If an OPO does not request
reconsideration or its request is not made timely, the OPO has no right
to further administrative review.
(3) Reconsideration determination. CMS makes a written reconsidered
determination within 10 business days of receipt of the request for
reconsideration, affirming, reversing, or modifying the initial
determination and the findings on which it was based. CMS augments the
administrative record to include any additional materials submitted by
the OPO, and a copy of the reconsideration decision and sends the
supplemented administrative record to the CMS hearing officer.
(c) Request for hearing. An OPO dissatisfied with the CMS
reconsideration decision, must file a request for a hearing before a
CMS hearing officer within 40 business days of receipt of the notice of
the reconsideration determination. If an OPO does not request a hearing
or its request is not received timely, the OPO has no right to further
administrative review.
(d) Administrative record. The hearing officer sends the
administrative record to both parties within 10 business days of
receipt of the request for a hearing.
(1) The administrative record consists of, but is not limited to,
the following:
(i) Factual findings from the survey(s) on the OPO conditions for
coverage.
(ii) Data from the outcome measures.
(iii) Rankings of OPOs based on the outcome data.
(iv) Correspondence between CMS and the affected OPO.
(2) The administrative record will not include any privileged
information.
(e) Pre-Hearing conference. At any time before the hearing, the CMS
hearing officer may call a pre-hearing conference if he or she believes
that a conference would more clearly define the issues. At the pre-
hearing conference, the hearing officer may establish the briefing
schedule, sets the hearing date, and addresses other
[[Page 31050]]
administrative matters. The hearing officer will issue an order
reflecting the results of the pre-hearing conference.
(f) Date of hearing. The hearing officer sets a date for the
hearing that is no more than 60 calendar days following the receipt of
the request for a hearing.
(g) Conduct of hearing. (1) The hearing is open to both parties,
CMS and the OPO.
(2) The hearing officer inquires fully into all the matters at
issue and receives in evidence the testimony of witnesses and any
documents that are relevant and material.
(3) The hearing officer provides the parties with an opportunity to
enter an objection to the inclusion of any document. The hearing
officer will consider the objection and will rule on the document's
admissibility.
(4) The hearing officer decides the order in which the evidence and
the arguments of the parties are presented and the conduct of the
hearing.
(5) The hearing officer rules on the admissibility of evidence and
may admit evidence that would be inadmissible under rules applicable to
court procedures.
(6) The hearing officer rules on motions and other procedural
items.
(7) The hearing officer regulates the course of the hearing and
conduct of counsel.
(8) The hearing officer may examine witnesses.
(9) The hearing officer takes any action authorized by the rules in
this subpart.
(h) Parties' rights. CMS and the OPO may:
(1) Appear by counsel or other authorized representative, in all
hearing proceedings.
(2) Participate in any pre-hearing conference held by the hearing
officer.
(3) Agree to stipulations as to facts which will be made a part of
the record.
(4) Make opening statements at the hearing.
(5) Present relevant evidence on the issues at the hearing.
(6) Present witnesses, who then must be available for cross-
examination, and cross-examine witnesses presented by the other party.
(7) Present oral arguments at the hearing.
(i) Hearing officer's decision. The hearing officer renders a
decision on the appeal of the notice of de-certification within 20
business days of the hearing.
(1) Reversal of de-certification. If the hearing officer reverses
CMS' determination to de-certify an OPO in a case involving the
involuntary termination of the OPO's agreement, CMS will not terminate
the OPO's agreement and will not de-certify the OPO.
(2) De-certification is upheld. If the de-certification
determination is upheld by the hearing officer, the OPO is de-certified
and it has no further administrative appeal rights.
(j) Extension of agreement. If there is insufficient time prior to
expiration of an agreement with CMS to allow for competition of the
service area and, if necessary, transition of the service area to a
successor OPO, CMS may choose to extend the OPO's agreement with CMS.
(k) Effects of de-certification. Medicare and Medicaid payments may
not be made for organ procurement services the OPO furnishes on or
after the effective date of de-certification. CMS will then open the
de-certified OPO's service area for competition as set forth in Sec.
486.316(c).
Sec. 486.316 Re-certification and competition processes.
(a) Re-Certification of OPOs. An OPO is re-certified for an
additional 4 years and its service area is not opened for competition
when the OPO:
(1) Meets all 3 outcome measure requirements at Sec. 486.318; and
(2) Has been shown by survey to be in compliance with the
requirements for certification at Sec. 486.303, including the
conditions for coverage at Sec. 486.320 through Sec. 486.348.
(b) De-certification and competition. If an OPO does not meet all 3
outcome measures as described in paragraph (a)(1) of this section or
the requirements described in paragraph (a)(2) of this section, the OPO
is de-certified. If the OPO does not appeal or the OPO appeals and the
reconsideration official and CMS hearing officer uphold the de-
certification, the OPO's service area is opened for competition from
other OPOs. The de-certified OPO is not permitted to compete for its
open area or any other open area. An OPO competing for an open service
area must submit information and data that describe the barriers in its
service area, how they affected organ donation, what steps the OPO took
to overcome them, and the results.
(c) Criteria to compete. To compete for an open service area, an
OPO must meet the criteria in paragraph (a) of this section and the
following additional criteria:
(1) The OPO's performance on the donation rate outcome measure and
yield outcome measure is at or above 100 percent of the mean national
rate averaged over the 4 years of the re-certification cycle; and
(2) The OPO's donation rate is at least 15 percentage points higher
than the donation rate of the OPO currently designated for the service
area.
(3) The OPO must compete for the entire service area.
(d) Criteria for selection. CMS will designate an OPO for an open
service area based on the following criteria:
(1) Performance on the outcome measures at Sec. 486.318;
(2) Relative success in meeting the process performance measures
and other conditions at Sec. Sec. 486.320 through 486.348;
(3) Contiguity to the open service area.
(4) Success in identifying and overcoming barriers to donation
within its own service area and the relevance of those barriers to
barriers in the open area. An OPO competing for an open service area
must submit information and data that describe the barriers in its
service area, how they affected organ donation, what steps the OPO took
to overcome them, and the results.
(e) No OPO applies. If no OPO applies to compete for a de-certified
OPO's open area, CMS may select a single OPO to take over the entire
open area or may adjust the service area boundaries of two or more
contiguous OPOs to incorporate the open area. CMS will make its
decision based on the criteria in paragraph (d) of this section.
Organ Procurement Organization Outcome Requirements
Sec. 486.318 Condition: Outcome measures.
(a) With the exception of OPOs operating exclusively in non-
contiguous U.S. states, commonwealths, territories, or possessions, an
OPO must meet all 3 of the following outcome measures:
(1) The OPO's donation rate of eligible donors as a percentage of
eligible deaths is no more than 1.5 standard deviations below the mean
national donation rate of eligible donors as a percentage of eligible
deaths, averaged over the 4 years of the re-certification cycle. Both
the numerator and denominator of an individual OPO's donation rate
ratio are adjusted by adding a 1 for each donation after cardiac death
donor and each donor over the age of 70;
(2) The observed donation rate is not significantly lower than the
expected donation rate for 18 or more months of the 36 months of data
used for re-certification, as calculated by the SRTR;
(3) At least 2 out of the 3 following yield measures are no more
than 1 standard deviation below the national mean, averaged over the 4
years of the re-certification cycle:
(i) The number of organs transplanted per standard criteria donor,
including pancreata used for islet cell transplantation;
[[Page 31051]]
(ii) The number of organs transplanted per expanded criteria donor,
including pancreata used for islet cell transplantation; and
(iii) The number of organs used for research per donor, including
pancreata used for islet cell research.
(b) For OPOs operating exclusively in non-contiguous U.S. states,
commonwealths, territories, and possessions, the OPO outcome measures
are as follows:
(1) The OPO's donation rate of eligible donors as a percentage of
eligible deaths is no more than 1.5 standard deviations below the mean
national donation rate of eligible donors as a percentage of eligible
deaths, averaged over the 4 years of the re-certification cycle. Both
the numerator and denominator of an individual OPO's donation rate
ratio are adjusted by adding a 1 for each donation after cardiac death
donor and each donor over the age of 70;
(2) The observed donation rate is not significantly lower than the
expected donation rate for 18 or more months of the 36 months of data
used for re-certification, as calculated by the SRTR;
(3) At least 2 out of the 3 following are no more than 1 standard
deviation below the national mean:
(i) The number of kidneys transplanted per standard criteria donor;
(ii) The number of kidneys transplanted per expanded criteria
donor; and
(iii) The number of organs used for research per donor, including
pancreata recovered for islet cell transplantation.
(c) Data for the outcome measures.
(1) An OPO's performance on the outcome measures is based on 36
months of data, beginning with January 1 of the first full year of the
re-certification cycle and ending 36 months later on December 31, 7
months prior to the end of the re-certification cycle.
(2) If an OPO takes over another OPO's service area on a date later
than January 1 of the first full year of the re-certification cycle so
that 36 months of data are not available to evaluate the OPO's
performance in its new service area, we will not hold the OPO
accountable for its performance in the new area until the end of the
following re-certification cycle when 36 months of data are available.
Organ Procurement Organization Process Performance Measures
Sec. 486.320 Condition: Participation in Organ Procurement and
Transplantation Network.
After being designated, an OPO must become a member of, participate
in, and abide by the rules and requirements of the OPTN established and
operated in accordance with section 372 of the Public Health Service
Act (42 U.S.C. 274). The term ``rules and requirements of the OPTN''
means those rules and requirements approved by the Secretary. No OPO is
considered out of compliance with section 1138(b)(1)(D) of the Act or
this section until the Secretary approves a determination that the OPO
failed to comply with the rules and requirements of the OPTN. The
Secretary may impose sanctions under section 1138 only after such non-
compliance has been determined in this manner.
Sec. 486.322 Condition: Relationships with hospitals, critical access
hospitals, and tissue banks.
(a) Standard: Hospital agreements. An OPO must have a written
agreement with 95 percent of the Medicare and Medicaid participating
hospitals and critical access hospitals in its service area that have
both a ventilator and an operating room and have not been granted a
waiver by CMS to work with another OPO. The agreement must describe the
responsibilities of both the OPO and hospital or critical access
hospital in regard to donation after cardiac death (if the OPO has a
protocol for donation after cardiac death) and the requirements for
hospitals at Sec. 482.45 or Sec. 485.643. The agreement must specify
the meaning of the terms ``timely referral'' and ``imminent death.''
(b) Standard: Designated requestor training for hospital staff. The
OPO must offer to provide designated requestor training on at least an
annual basis for hospital and critical access hospital staff.
(c) Standard: Cooperation with tissue banks.
(1) The OPO must have arrangements to cooperate with tissue banks
that have agreements with hospitals and critical access hospitals with
which the OPO has agreements. The OPO must cooperate in the following
activities, as may be appropriate, to ensure that all usable tissues
are obtained from potential donors:
(i) Screening and referral of potential tissue donors.
(ii) Obtaining informed consent from families of potential tissue
donors.
(iii) Retrieval, processing, preservation, storage, and
distribution of tissues.
(iv) Providing designated requestor training.
(2) An OPO is not required to have an arrangement with a tissue
bank that is unwilling to have an arrangement with the OPO.
Sec. 486.324 Condition: Administration and governing body.
(a) While an OPO may have more than one board, the OPO must have an
advisory board that has both the authority described in paragraph (b)
of this section and the following membership:
(1) Members who represent hospital administrators, either intensive
care or emergency room personnel, tissue banks, and voluntary health
associations in the OPO's service area.
(2) Individuals who represent the public residing in the OPO's
service area.
(3) A physician with knowledge, experience, or skill in the field
of human histocompatibility, or an individual with a doctorate degree
in a biological science and with knowledge, experience, or skills in
the field of human histocompatibility.
(4) A neurosurgeon or other physician with knowledge or skills in
the neurosciences.
(5) A transplant surgeon representing each transplant hospital in
the service area with which the OPO has arrangements to coordinate its
activities. The transplant surgeon must have practicing privileges and
perform transplants in the transplant hospital represented.
(6) An organ donor family member.
(b) The OPO board described in paragraph (a) of this section has
the authority to recommend policies for the following:
(1) Procurement of organs.
(2) Effective agreements to identify potential organ donors with a
substantial majority of hospitals in its service area that have
facilities for organ donation.
(3) Systematic efforts, including professional education, to
acquire all useable organs from potential donors.
(4) Arrangements for the acquisition and preservation of donated
organs and provision of quality standards for the acquisition of organs
that are consistent with the standards adopted by the OPTN, including
arranging for testing with respect to preventing the acquisition of
organs that are infected with the etiologic agent for acquired
immunodeficiency syndrome (AIDS).
(5) Appropriate tissue typing of organs.
(6) A system for allocation of organs among transplant patients
that is consistent with the rules and requirements of the OPTN, as
defined in Sec. 486.320 of this part.
(7) Transportation of organs to transplant hospitals.
(8) Coordination of activities with transplant hospitals in the
OPO's service area.
[[Page 31052]]
(9) Participation in the OPTN.
(10) Arrangements to cooperate with tissue banks for the retrieval,
processing, preservation, storage, and distribution of tissues as may
be appropriate to assure that all useable tissues are obtained from
potential donors.
(11) Annual evaluation of the effectiveness of the OPO in acquiring
organs.
(12) Assistance to hospitals in establishing and implementing
protocols for making routine inquiries about organ donations by
potential donors.
(c) The advisory board described in paragraph (a) of this section
has no authority over any other activity of the OPO and may not serve
as the OPO's governing body or board of directors. Members of the
advisory board described in paragraph (a) of this section are
prohibited from serving on any other OPO board.
(d) The OPO must have bylaws for each of its board(s) that address
potential conflicts of interest, length of terms, and criteria for
selecting and removing members. (e) A governing body must have full
legal authority and responsibility for the management and provision of
all OPO services and must develop and oversee implementation of
policies and procedures considered necessary for the effective
administration of the OPO, including fiscal operations, the OPO's
quality assessment and performance improvement (QAPI) program, and
services furnished under contract or arrangement, including agreements
for these services. The governing body must appoint an individual to be
responsible for the day-to-day operation of the OPO.
(e) A governing body must have full legal authority and
responsibility for the management and provision of all OPO services and
must develop and oversee implementation of policies and procedures
considered necessary for the effective administration of the OPO,
including fiscal operations, the OPO's quality assessment and
performance improvement (QAPI) program, and services furnished under
contract or arrangement, including agreements for these services. The
governing body must appoint an individual to be responsible for the
day-to-day operation of the OPO.
(f) The OPO must have procedures to address potential conflicts of
interest for the governing body described in paragraph (d) of this
section.
(g) The OPO's policies must state whether the OPO recovers organs
from donors after cardiac death.
Sec. 486.326 Condition: Human resources.
All OPOs must have a sufficient number of qualified staff,
including a director, a medical director, organ procurement
coordinators, and hospital development staff to obtain all usable
organs from potential donors, and to ensure that required services are
provided to families of potential donors, hospitals, tissue banks, and
individuals and facilities that use organs for research.
(a) Standard: Qualifications. (1) The OPO must ensure that all
individuals who provide services and/or supervise services, including
services furnished under contract or arrangement, are qualified to
provide or supervise the services.
(2) The OPO must develop and implement a written policy that
addresses potential conflicts of interest for the OPO's director,
medical director, senior management, and procurement coordinators.
(3) The OPO must have credentialing records for physicians and
other practitioners who routinely recover organs in hospitals under
contract or arrangement with the OPO and ensure that all physicians and
other practitioners who recover organs in hospitals with which the OPO
has agreements are qualified and trained.
(b) Standard: Staffing.
(1) The OPO must provide sufficient coverage, either by its own
staff or under contract or arrangement, to assure both that hospital
referral calls are screened for donor potential and that potential
donors are evaluated for medical suitability for organ and/or tissue
donation in a timely manner.
(2) The OPO must have a sufficient number of qualified staff to
provide information and support to potential organ donor families;
request consent for donation; ensure optimal maintenance of the donor,
efficient placement of organs, and adequate oversight of organ
recovery; and conduct QAPI activities, such as death record reviews and
hospital development.
(3) The OPO must provide a sufficient number of recovery personnel,
either from its own staff or under contract or arrangement, to ensure
that all usable organs are recovered in a manner that, to the extent
possible, preserves them for transplantation.
(c) Standard: Education, training, and performance evaluation. The
OPO must provide its staff with the education, training, and
supervision necessary to furnish required services. Training must
include but is not limited to performance expectations for staff,
applicable organizational policies and procedures, and QAPI activities.
OPOs must evaluate the performance of their staffs and provide
training, as needed, to improve individual and overall staff
performance and effectiveness.
(d) Standard: Medical director. The OPO's medical director is a
physician licensed in at least one of the States or territories within
the OPO's service area or as required by State or territory law or by
the jurisdiction in which the OPO is located. The medical director is
responsible for implementation of the OPO's protocols for donor
evaluation and management and organ recovery and placement. The medical
director is responsible for oversight of the clinical management of
potential donors, including providing assistance in managing a donor
case when the surgeon on call is unavailable.
Sec. 486.328 Condition: Reporting of data.
(a) An OPO must provide individually-identifiable, hospital-
specific organ donation and transplantation data and other information
to the Organ Procurement and Transplantation Network, the Scientific
Registry of Transplant Recipients, and DHHS, as requested by the
Secretary. The data may include, but are not limited to:
(1) Number of hospital deaths;
(2) Results of death record reviews;
(3) Number and timeliness of referral calls from hospitals;
(4) Number of eligible deaths;
(5) Data related to non-recovery of organs;
(6) Data about consents for donation;
(7) Number of eligible donors;
(8) Number of organs recovered, by type of organ; and
(9) Number of organs transplanted, by type of organ.
(b) An OPO must provide hospital-specific organ donation data
annually to the transplant hospitals with which it has agreements.
(c) Data to be used for OPO re-certification purposes must be
reported to the OPTN and must include data for all deaths in all
hospitals and critical access hospitals in the OPO's donation service
area, unless a hospital or critical access hospital has been granted a
waiver to work with a different OPO.
(d) Data reported by the OPO to the OPTN must be reported within 30
days after the end of the month in which a death occurred. If an OPO
determines through death record review or other means that the data it
reported to the OPTN was incorrect, it must report the corrected data
to the OPTN within 30 days of the end of the month in which the error
is identified.
(e) For the purpose of determining the information to be collected
under
[[Page 31053]]
paragraph (a) of this section, the following definitions apply:
(1) Kidneys procured. Each kidney recovered will be counted
individually. En bloc kidneys recovered will count as two kidneys
procured.
(2) Kidneys transplanted. Each kidney transplanted will be counted
individually. En bloc kidney transplants will be counted as two kidneys
transplanted.
(3) Extra-renal organs procured. Each organ recovered is counted
individually.
(4) Extra-renal organs transplanted. Each organ or part thereof
transplanted will be counted individually. For example, a single liver
is counted as one organ procured and each portion that is transplanted
will count as one transplant. Further, a heart and double lung
transplant will be counted as three organs transplanted. A kidney/
pancreas transplant will count as one kidney transplanted and one
extra-renal organ transplanted.
Sec. 486.330 Condition: Information management.
An OPO must establish and use an electronic information management
system to maintain the required medical, social and identifying
information for every donor and transplant recipient and develop and
follow procedures to ensure the confidentiality and security of the
information.
(a) Donor information. The OPO must maintain a record for every
donor. The record must include, at a minimum, information identifying
the donor (for example, name, address, date of birth, social security
number or other unique identifier, such as Medicare health insurance
claim number), organs and (when applicable) tissues recovered, date of
the organ recovery, donor management data, all test results, current
hospital history, past medical and social history, the pronouncement of
death, and consent and next-of-kin information.
(b) Disposition of organs. The OPO must maintain records showing
the disposition of each organ recovered for the purpose of
transplantation, including information identifying transplant
recipients.
(c) Data retention. Donor and transplant recipient records must be
maintained in a human readable and reproducible paper or electronic
format for 7 years.
(d) Format of records. The OPO must maintain data in a format that
can readily be transferred to a successor OPO and in the event of a
transfer must provide to CMS copies of all records, data, and software
necessary to ensure uninterrupted service by a successor OPO. Records
and data subject to this requirement include donor and transplant
recipient records and procedural manuals and other materials used in
conducting OPO operations.
Sec. 486.342 Condition: Requesting consent.
An OPO must encourage discretion and sensitivity with respect to
the circumstances, views, and beliefs of potential donor families.
(a) An OPO must have a written protocol to ensure that, in the
absence of a donor document, the individual(s) responsible for making
the donation decision are informed of their options to donate organs or
tissues (when the OPO is making a request for tissues) or to decline to
donate. The OPO must provide to the individual(s) responsible for
making the donation decision, at a minimum, the following:
(1) A list of the organs and/or tissues that may be recovered.
(2) The most likely uses for the donated organs or tissues.
(3) A description of the screening and recovery processes.
(4) Information about the organizations that will recover, process,
and distribute the tissue.
(5) Information regarding access to and release of the donor's
medical records.
(6) An explanation of the impact the donation process will have on
burial arrangements and the appearance of the donor's body.
(7) Contact information for individual(s) with questions or
concerns.
(8) A copy of the signed consent form if a donation is made.
(b) If an OPO does not request consent to donation because a
potential donor consented to donation before his or her death in a
manner that satisfied applicable State law requirements in the
potential donor's State of residence, the OPO must provide information
about the donation to the family of the potential donor, as requested.
Sec. 486.344 Condition: Evaluation and management of potential donors
and organ placement and recovery.
The OPO must have written protocols for donor evaluation and
management and organ placement and recovery that meet current standards
of practice and are designed to maximize organ quality and optimize the
number of donors and the number of organs recovered and transplanted
per donor.
(a) Potential donor protocol management. (1) The medical director
is responsible for ensuring that potential donor evaluation and
management protocols are implemented correctly and appropriately to
ensure that potential donors are thoroughly assessed for medical
suitability for organ donation and clinically managed to optimize organ
viability and function.
(2) The OPO must implement a system that ensures that a qualified
physician or other qualified individual is available to assist in the
medical management of a potential donor when the surgeon on call is
unavailable.
(b) Potential donor evaluation. The OPO must do the following:
(1) Verify that death has been pronounced according to applicable
local, State, and Federal laws.
(2) Determine whether there are conditions that may influence donor
acceptance.
(3) If possible, obtain the potential donor's medical and social
history.
(4) Review the potential donor's medical chart and perform a
physical examination of the donor.
(5) Obtain the potential donor's vital signs and perform all
pertinent tests.
(c) Testing. The OPO must do the following:
(1) Arrange for screening and testing of the potential donor for
infectious disease according to current standards of practice,
including testing for the human immunodeficiency virus.
(2) Ensure that screening and testing of the potential donor
(including point-of-care testing and blood typing) are conducted by a
laboratory that is certified in the appropriate specialty or
subspecialty of service in accordance with part 493 of this chapter.
(3) Ensure that the potential donor's blood is typed using two
separate blood samples.
(4) Document potential donor's record with all test results,
including blood type, before organ recovery.
(d) Standard: Collaboration with transplant programs.
(1) The OPO must establish protocols in collaboration with
transplant programs that define the roles and responsibilities of the
OPO and the transplant program for all activities associated with the
evaluation and management of potential donors, organ recovery, and
organ placement, including donation after cardiac death, if the OPO has
implemented a protocol for donation after cardiac death.
(2) The protocol must ensure that:
(i) The OPO is responsible for two separate determinations of the
donor's blood type;
(ii) If the identify of the intended recipient is known, the OPO
has a procedure to ensure that prior to organ recovery, an individual
from the OPO's staff compares the blood type of the
[[Page 31054]]
donor with the blood type of the intended recipient, and the accuracy
of the comparison is verified by a different individual;
(iii) Documentation of the donor's blood type accompanies the organ
to the hospital where the transplant will take place.
(3) The established protocols must be reviewed regularly with the
transplant programs to incorporate practices that have been shown to
maximize organ donation and transplantation.
(e) Documentation of recipient information. If the intended
recipient has been identified prior to recovery of an organ for
transplantation, the OPO must have written documentation from the OPTN
showing, at a minimum, the intended organ recipient's ranking in
relation to other suitable candidates and the recipient's OPTN
identification number and blood type.
(f) Donation after cardiac death. If an OPO recovers organs from
donors after cardiac death, the OPO must have protocols that address
the following:
(1) Criteria for evaluating patients for donation after cardiac
death;
(2) Withdrawal of support, including the relationship between the
time of consent to donation and the withdrawal of support;
(3) Use of medications and interventions not related to withdrawal
of support;
(4) Involvement of family members prior to organ recovery;
(5) Criteria for declaration of death and the time period that must
elapse prior to organ recovery.
(g) Organ allocation. The OPO must have a system to allocate
donated organs among transplant patients that is consistent with the
rules and requirements of the OPTN, as defined in Sec. 486.320 of this
part.
(h) Organ placement. The OPO must develop and implement a protocol
to maximize placement of organs for transplantation.
Sec. 486.346 Condition: Organ preparation and transport.
(a) The OPO must arrange for testing of organs for infectious
disease and tissue typing of organs according to current standards of
practice. The OPO must ensure that testing and tissue typing of organs
are conducted by a laboratory that is certified in the appropriate
specialty or subspecialty of service in accordance with part 493 of
this chapter.
(b) The OPO must send complete documentation of donor information
to the transplant center with the organ, including donor evaluation,
the complete record of the donor's management, documentation of
consent, documentation of the pronouncement of death, and documentation
for determining organ quality. Two individuals, one of whom must be an
OPO employee, must verify that the documentation that accompanies an
organ to a transplant center is correct.
(c) The OPO must develop and follow a written protocol for
packaging, labeling, handling, and shipping organs in a manner that
ensures their arrival without compromise to the quality of the organ.
The protocol must include procedures to check the accuracy and
integrity of labels, packaging, and contents prior to transport,
including verification by two individuals, one of whom must be an OPO
employee, that information listed on the labels is correct.
(d) All packaging in which an organ is transported must be marked
with the identification number, specific contents, and donor's blood
type.
Sec. 486.348 Condition: Quality assessment and performance
improvement (QAPI).
The OPO must develop, implement, and maintain a comprehensive,
data-driven QAPI program designed to monitor and evaluate performance
of all donation services, including services provided under contract or
arrangement.
(a) Standard: Components of a QAPI program. The OPO's QAPI program
must include objective measures to evaluate and demonstrate improved
performance with regard to OPO activities, such as hospital
development, designated requestor training, donor management,
timeliness of on-site response to hospital referrals, consent
practices, organ recovery and placement, and organ packaging and
transport. The OPO must take actions that result in performance
improvements and track performance to ensure that improvements are
sustained.
(b) Standard: Death record reviews. As part of its ongoing QAPI
efforts, an OPO must conduct at least monthly death record reviews in
every Medicare and Medicaid participating hospital in its service area
that has a Level I or Level II trauma center or 150 or more beds, a
ventilator, and an intensive care unit (unless the hospital has a
waiver to work with another OPO), with the exception of psychiatric and
rehabilitation hospitals. When missed opportunities for donation are
identified, the OPO must implement actions to improve performance.
(c) Standard: Adverse events.
(1) An OPO must establish written policies to address, at a
minimum, the process for identification, reporting, analysis, and
prevention of adverse events that occur during the organ donation
process.
(2) The OPO must conduct a thorough analysis of any adverse event
and must use the analysis to affect changes in the OPO's policies and
practices to prevent repeat incidents.
PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTICIPATION OF ICFs/MR AND CERTAIN NFs IN THE MEDICAID
PROGRAM
0
1. The authority citation for part 498 continues to read as follows:
Authority: Sections 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart A--General Provisions
Sec. 498.2 [Amended]
0
2. In Sec. 498.2, the definition of ``supplier'' is amended by
removing ``organ procurement organization (OPO),''.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: May 11, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: May 19, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06-4882 Filed 5-30-06; 8:45 am]
BILLING CODE 4120-01-P