Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs), 30982-31054 [06-4882]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 104 (Wednesday, May 31, 2006)]
[Rules and Regulations]
[Pages 30982-31054]
From the Federal Register Online via the Government Printing 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

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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.'' (https://
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

[[Page 30986]]

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 phr