[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Rules and Regulations]
[Pages 15198-15280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1435]



[[Page 15197]]

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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 405, 482, 488, and 498



Medicare Program; Hospital Conditions of Participation: Requirements 
for Approval and Re-Approval of Transplant Centers To Perform Organ 
Transplants; Final Rule

  Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules 
and Regulations  

[[Page 15198]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 482, 488, and 498

[CMS-3835-F]
RIN 0938-AH17


Medicare Program; Hospital Conditions of Participation: 
Requirements for Approval and Re-Approval of Transplant Centers To 
Perform Organ Transplants

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule establishes, for the first time, Medicare 
conditions of participation for heart, heart-lung, intestine, kidney, 
liver, lung, and pancreas transplant centers. This rule sets forth 
clear expectations for safe, high quality transplant service delivery 
in Medicare-participating facilities. In addition, in this rule we 
respond to public comments on the proposed rule.

EFFECTIVE DATES: These regulations are effective on June 28, 2007.

FOR FURTHER INFORMATION CONTACT: Eva Fung, (410) 786-7539. Marcia 
Newton, (410) 786-5265. Diane Corning, (410) 786-8486. Jeannie Miller, 
(410) 786-3164. Rachael Weinstein, (410) 786-6775.

SUPPLEMENTARY INFORMATION:

I. Background

A. Key Statutory Provisions

    Section 1102 of the Social Security Act (the Act) authorizes the 
Secretary to publish rules and regulations ``necessary for the 
efficient administration of the functions'' with which the Secretary is 
charged under the Act. Section 1871(a) of the Act authorizes the 
Secretary to ``prescribe such regulations as may be necessary to carry 
out the administration of the insurance programs under this title.''
    Section 1864 of the Act authorizes the use of State agencies to 
determine providers' compliance with Medicare conditions of 
participation (CoPs). Responsibilities of the States in ensuring 
compliance with the CoPs are set forth in regulations at 42 CFR part 
488, Survey, Certification, and Enforcement Procedures. Under section 
1865 of the Act and Sec.  488.5 of the regulations, hospitals that are 
accredited by the Joint Commission on Accreditation of Healthcare 
Organizations (JCAHO) or the American Osteopathic Association (AOA) are 
not routinely surveyed by State agency surveyors for compliance with 
the conditions, but are deemed to meet most of the requirements in the 
hospital CoPs based on their accreditation. JCAHO, AOA, and other 
national accreditation programs with deeming authority under Sec.  
488.6 of the regulations must meet requirements that are at least as 
stringent as the Medicare CoPs. (See Part 488, Survey and Certification 
Procedures.) An accreditation organization must apply for and receive 
approval of deeming authority from CMS.
    Section 1865(b)(1) of the Act states that providers of certain 
services listed in section 1881(b) of the Act cannot be deemed by a 
national accreditation body to meet the Medicare conditions of 
participation. Kidney transplant centers are entities listed in 
1881(b); thus, they cannot be deemed to be accredited.
    Section 1881(b)(1) of the Act contains specific authority for 
prescribing the health and safety requirements for facilities, 
including renal transplant centers, that furnish end stage renal 
disease (ESRD) care to beneficiaries.

B. Past Medicare Policy Regarding Transplantation

    Until now, kidney transplant centers have participated in Medicare 
by meeting requirements set forth at 42 CFR Part 405, subpart U, 
``Conditions for Coverage of Suppliers of End Stage Renal Disease 
(ESRD) Services.'' These requirements address issues such as compliance 
with applicable Federal, State, and local laws and regulations; 
governing body; patient care plans; patients' rights; medical records; 
and the physical environment. In addition, the ESRD conditions for 
coverage (CfCs) delineate minimum utilization rates, requirements for 
the director of transplantation, and minimum service requirements. (See 
405.2170 and 405.2171.) Likewise, we have regulated extra-renal 
transplant centers under various national coverage decisions (NCDs) 
published beginning in 1987. The NCDs have been based on the 
``reasonable and necessary'' provision of the Medicare statute (section 
1862(a)(1)(A) of the Act). Generally, under section 1862(a)(1)(A), 
Medicare does not pay for any item or service unless it is medically 
reasonable and necessary. The NCDs provide that transplantation of 
extra-renal organs will be considered reasonable and necessary if 
performed in a center that meets the criteria specified in the 
applicable NCD.

C. Our Efforts To Improve Oversight of Transplant Centers

    In the preamble of the proposed transplant center rule published 
February 4, 2005 (70 FR 6140), we discussed our efforts that are 
underway to improve organ donation and transplantation services, 
including the Secretary's Gift of Life Initiative. Publication of the 
proposed rule for new CoPs for transplant centers was the first step in 
moving toward a stronger oversight process. In February 2004, the 
Office of the Inspector General (OIG) published a report titled 
``Medicare-approved Heart Transplant Centers'' (OEI-01-02-00520), and 
outlined three recommendations for CMS oversight of heart transplant 
centers: (1) CMS should expedite the development of continuing criteria 
for volume and survival rate performance and for periodic re-
certification; (2) CMS should develop guidelines and procedures for 
taking actions against centers that do not meet Medicare criteria for 
volume and survival rate; and (3) CMS should take immediate steps to 
improve its ability to maintain accurate and timely data on center 
performance. All of the OIG's recommendations were incorporated into 
the rule.
    Through this final rule, we are codifying requirements for approval 
and re-approval of transplant centers as CoPs and placing Medicare-
approved transplant centers under the survey and certification 
enforcement process used for all other providers and suppliers of 
Medicare services.
    Since publication of the proposed rule, we have identified quality 
and service issues that some transplant centers are experiencing. For 
example, in 2005, we investigated and cited a hospital whose liver 
transplant center was accused of turning down a large number of organs 
offered for the patients on its waiting list. As a result, the hospital 
closed its liver transplant center. In addition, the Government 
Accountability Office (GAO) is currently reviewing the Department's 
oversight of the transplantation system in the United States.
    Our current oversight of transplant centers relies on self-
reporting of significant changes within a transplant center, as well as 
beneficiary complaints that may lead to a review or survey of a 
transplant center. The transplant center NCDs do not delineate explicit 
criteria for de-certifying of organ transplant programs. In this final 
rule, we are responding to public comments on the proposed rule and 
recommendations for improvement to this system by setting forth 
explicit

[[Page 15199]]

expectations for outcomes, and high quality transplantation services.
    We are codifying the requirements for the approval and re-approval 
of transplant centers as an option under part 482, subpart E, for 
hospitals that choose to perform transplants. This final rule applies 
to hospitals with heart, heart-lung, intestine, kidney, liver, lung, 
and pancreas transplant centers. For purposes of this final rule, 
heart-lung transplant centers are those centers that are located in a 
hospital with an existing Medicare-approved heart transplant center and 
an existing Medicare-approved lung center that performs combined heart-
lung transplants. Intestine centers are those Medicare-approved liver 
transplant centers that perform intestine transplants, combined liver-
intestine transplants, and multivisceral transplants. Pancreas centers 
are those Medicare-approved kidney transplant centers that perform 
pancreas transplants, alone or subsequent to a kidney transplant, and 
that also perform kidney-pancreas transplants.

II. Provisions of the Proposed Rule and Response to Comments on the 
February 4, 2005 Proposed Rule

    In the February 4, 2005 Federal Register (70 FR 6140), we published 
the proposed rule entitled, ``Hospital Conditions of Participation: 
Requirements for Approval and Re-approval of Transplant Centers to 
Perform Organ Transplants'' and provided for a 60-day comment period. 
On March 25, 2005, we published a notice in the Federal Register (70 FR 
15264) extending the comment period for an additional 60 days, until 
June 6, 2005, to allow sufficient time for the public to provide 
comments on the large number of proposed new requirements.
    The proposed rule set forth new hospital CoPs for the approval and 
re-approval of transplant centers at 42 CFR part 482, subpart E. 
Additionally, following publication of the proposed rule, we conducted 
an external, independent peer review of several of the technical 
aspects associated with the proposed outcome measures and options. We 
contacted five scientists, of which three sent us detailed comments to 
address the technical questions that we raised. One scientist declined 
to provide detailed comments but said his views were reflected by the 
comments provided by the American Society of Transplant Surgeons/
American Transplantation Society (ASTS/ATS). Comments provided by the 
ASTS/ATS partially addressed these technical issues, as well as more 
general issues of concern to the society. These peer reviews were 
received during the public comment period. Below we respond to the 
comments of the peer reviewers, in addition to the public comments 
received during the comment period.
    We received a total of 91 comments: 48 from individual transplant 
centers; 10 from professional associations representing those who work 
in the field of transplantation (including physicians, surgeons, 
dietitians, nurses, social workers, transplant coordinators, 
hospitals), 2 from organizations that support transplantation, (that 
is, the National Kidney Foundation and National Liver Foundation); 9 
from individual social workers; 6 from individual transplant 
coordinators; 5 from individual organ procurement organizations; and 11 
from various sources (including the Scientific Registry of Transplant 
Recipients, United Network for Organ Sharing, the Secretary's Advisory 
Committee on Organ Transplantation, the New York State Department of 
Health, the Joint Commission on Accreditation of Healthcare 
Organizations, individual physicians, a histocompatability laboratory, 
a living donor, and a dialysis facility). The comments ranged from 
general support or opposition to the proposed conditions of 
participation to very specific questions or comments regarding the 
proposed criteria. Note that comments made by peer reviewers are 
identified specifically as peer review comments. All other comments 
were made by the public.
    Brief summaries of each proposed provision, a summary of the public 
comments we received (with the exception of specific comments on the 
paperwork burden or the economic impact analysis), and our responses to 
the comments are set forth below. Comments related to the paperwork 
burden and the impact analysis are addressed in the Collection of 
Information and Impact Analysis Sections in this preamble.

General Comments

    Comment: Many commenters supported and commended our efforts to 
update Medicare approval and re-approval requirements for transplant 
centers. Some commenters indicated they were impressed by our 
recognition of the highly complex issues faced by transplant recipients 
and living donors. Other commenters stated that the rationales provided 
in the February 4, 2005 proposed rule were based on sound medical and 
transplant practices. Some commenters stated that this rule may help to 
decrease organ wastage and graft failure, which would reduce the need 
for kidney dialysis services and re-transplantation of failed organs.
    Some of the professional associations and three peer reviewers 
supported our efforts to update transplantation standards for Medicare-
approved centers, codify standards for extra-renal organ transplants, 
and improve care for Medicare beneficiaries and living donors. One peer 
reviewer was pleased with the comprehensiveness of the proposed rule, 
which the peer reviewer said builds upon the work of the Organ 
Procurement and Transplantation Network (OPTN), the Scientific Registry 
of Transplant Recipients (SRTR), and the Health Resources and Services 
Administration (HRSA). Another peer reviewer supported the re-approval 
process and stated that a mechanism to re-approve transplant centers is 
essential.
    Response: We thank the commenters and peer reviewers for their 
assistance in developing this final rule. We are committed to ensuring 
that Medicare-approved transplant centers consistently maintain the 
expertise and resources necessary to provide high quality 
transplantation services to patients.
    Comment: A few commenters stated that the proposed rule was too 
prescriptive and expressed concerns that implementation of the rule 
would bring extra burden to transplant centers, especially kidney 
transplant centers, in terms of cost and nursing hours. One commenter 
suggested a more general approach as opposed to using prescriptive 
language. One commenter inquired about the source of funding for the 
extra expenses generated by this rule.
    Response: One of our goals in publishing new CoPs for transplant 
centers is to provide flexibility for transplant centers within the 
framework of our regulatory authority. As stated in the proposed rule, 
we have set forth requirements that we believe are absolutely necessary 
to ensure quality care and protect the health and safety of patients. 
All of the CoPs are specifically transplant-oriented, and we believe 
that nearly all requirements in this final rule clarify or strengthen 
normal business practices for most transplant centers. Centers that 
have not incorporated the requirements in this final rule into their 
normal business practices will need to assess their transplantation 
practices and improve their performance. We believe this rule will 
strengthen accountability of transplant centers, and we expect centers 
to maintain compliance with the requirements in this final rule and 
continuously strive to improve quality of care and patient and

[[Page 15200]]

living donor safety in their pursuit of optimal outcomes.
    We believe this rule will neither increase nursing workloads nor 
create significant burdens for centers, including kidney centers. We 
estimate that on average, the cost for each currently-approved Medicare 
transplant center to comply will be less than $56,000 in the first full 
year following the effective date of the final rule and less than 
$21,000 in subsequent years.
    Comment: A peer reviewer expressed concern that the level of detail 
in the proposed rule may hamper the Agency's ability to make needed 
modifications in the future.
    Response: We have included only those requirements that we believe 
are absolutely essential for ensuring quality care and protecting the 
health and safety of Medicare beneficiaries and living donors. From an 
oversight perspective, we must be specific in our expectations so that 
providers clearly understand the requirements for Medicare 
participation.
    We will continue to stay abreast of the latest advances in 
transplantation. If hospitals significantly change how they provide 
transplant patient care or the SRTR changes its outcome measure 
methodology, we will review and revise the final rule as necessary.
    Comment: One commenter stated that the OPTN oversight process and 
the CoPs would create inconsistent parallels for review of transplant 
center performance. Another commenter was concerned that the OPTN and 
the proposed CMS review processes were duplicative or inconsistent in 
some areas. The commenter believed that the OPTN oversight and 
compliance with the Medicare CoPs should be consistent and work in 
tandem.
    Response: Our intent is that OPTN policies and the requirements in 
this final rule will complement but not duplicate each other. 
Nevertheless, in some instances, we have incorporated OPTN policies 
into our requirements so that they are enforceable under Medicare. 
Below is a crosswalk chart that shows overlap and differences between 
OPTN policies and CMS regulations:

Crosswalk of Transplant Center Final Rule, Part 121, & OPTN Policies and
                                 Bylaws
------------------------------------------------------------------------
                                   42 CFR Part 121,
                                  OPTN policies, and
        CMS requirements              bylaws for           Comments
                                  transplant centers
------------------------------------------------------------------------
Main focuses of CMS               Part 121 sets       Main focuses of
 requirements.                     forth the           OPTN policies/
 Regulatory oversight of   governing           Bylaws.
 transplant centers..              structure of the    Organ
 Patient care &            OPTN and sets       allocation.
 transplant services furnished     standards for      
 to beneficiaries..                availability of     Credential of
 Relationship with         organ               transplant
 transplant centers based on       transplantation     surgeons/
 Provider Agreement & Medicare     data. Part 121      physicians.
 reimbursement..                   lays out           
 Medicare approval & re-   requirements for    Relationship with
 approval based on compliance      transplant          transplant
 with Conditions of                program in          hospital members
 participation (CoPs)..            hospitals at Sec.   is collegial with
 Provider                   Sec.   121.9 and   the goal to help
 responsibilities..                121.11(b)(1)(C)     them to improve
                                   (defined as OMB-    performance.
                                   approved OPTN       OPTN
                                   forms).             Membership
                                  Main focuses of      application
                                   Part 121..          reviewed by peer
                                   Govern      reviewers.
                                   the operation of    Member
                                   the OPTN which is   obligations.
                                   under contract     *Additional
                                   with HRSA.          requirements for
                                   Require     non-Medicare
                                   OPTN to develop     approved
                                   policies for its    transplant
                                   members. However,   programs.
                                   as of today, with
                                   the exception of
                                   ``data submission
                                   requirements'',
                                   none of the OPTN
                                   polices have been
                                   enforceable
                                   because they have
                                   not been approved
                                   and published by
                                   the Secretary.
Sec.   482.68 Special             Compliance with      This rule
 Requirements for transplant       Part 121.           now makes the
 centers.                         OPTN membership      data submission
In order to be granted approval    requirements..      requirements of
 from CMS to provide transplant                        OPTN a Condition
 services, a transplant center                         of Participation.
 must:.                                               
 Be located within a                           Transplant
 hospital that has a Medicare                          centers must
 provider agreement..                                  comply with CoPs
 Meet the CoPs of this                         to be reimbursed.
 final rule..
 Meet all hospital CoPs.
Sec.   482.70 Definitions.        Generic             No comparable OPTN
CMS has specific definitions for   definitions in      definitions.
 certain types of centers.         part 121.
Sec.   482.72 Condition of        Sec.   121.9
 participation: OPTN membership.   Designated
                                   transplant
                                   program
                                   requirements.
A transplant center must be        (a) To
 located in a transplant           receive organs
 hospital that is a member of      for
 and abides by the approved        transplantation,
 rules and requirements of the     a transplant
 OPTN established and operated     program must be
 in accordance with Sec.   372     in a hospital
 of the Public Health Service      that is a member
 (PHS) Act (42 U.S.C. section      of the OPTN.
 274).
Sec.   482.74 Condition of        OPTN Bylaw          CMS adopts the
 participation: Notification to    Appendix B-3.       OPTN bylaw and
 CMS.                                                  adds more
                                                       requirements.
A transplant center must notify   OPTN member
 CMS immediately of any            programs must
 significant changes related to    notify OPTN
 the center's transplant program   immediately when
 or changes that would alter       a key person
 elements in the approval/re-      plans to leave.
 approval application:
 A change in key staff
 members of the transplant team.
 A decrease in the
 center's volume or survival
 rates.

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 Termination of an
 agreement between the hospital
 in which the transplant center
 is located and an OPO for the
 recovery and receipt of organs.
 Inactivation of the
 transplant center.
Sec.   482.76 Condition of        ..................  No specific OPTN
 participation: Pediatric                              policy/bylaw for
 Hospitals.                                            pediatric
                                                       transplant
                                                       programs.
 With the exceptions of
 heart centers, pediatric
 centers that wish to provide
 transplantation services to
 both adult and pediatric
 transplants must meet all
 requirements (except for
 clinical experience) in this
 rule and request separate
 Medical approval.
 A center that mostly
 performs adult transplants
 cannot be approved to perform
 pediatric transplants if they
 lose their approval to perform
 adult transplants.
 A center that mostly
 performs pediatric transplants
 cannot be approved to perform
 adult transplants if they lose
 their approval to perform
 pediatric transplants.
 Heart centers that want
 to obtain Medicare approval for
 pediatric transplants have the
 option to be approved under the
 criteria listed under OBRA
 1987.
Sec.   482.80 Condition of        Sec.                By using the
 participation: Data submission,   121.11(b)(2)        publicly
 clinical experience, and          Reporting           available SRTR
 outcome requirements for          requirements.       data for outcome
 INITIAL APPROVAL of transplant    Member transplant   measures, CMS's
 centers.                          hospitals must      outcome
(a) Standard: Data submission.     submit to the       complements Part
 No later than 90 days after the   Secretary           121.
 due date established by the       information as     CMS adopts the
 OPTN, a transplant center must    the Secretary       OPTN policy for
 submit to the OPTN at least 95    prescribes (OPTN    the most part.
 percent of required data on all   forms).
 transplants (deceased and        Sec.
 living donor) it has performed..  121.11(b)(1)(C).
                                   The OPTN
                                   & the SRTR shall
                                   provide to the
                                   Secretary any
                                   data that the
                                   Secretary
                                   requests.
                                   Make
                                   available to the
                                   public timely &
                                   accurate program-
                                   specific
                                   information on
                                   the performance
                                   of transplant
                                   programs.
                                  OPTN Policy 7.8
                                   Data Submission
                                   Requirements.
                                   Each
                                   transplant center
                                   must collect &
                                   submit 95% of
                                   expected forms
                                   complete within 3
                                   months of the due
                                   date and 100% of
                                   expected forms
                                   complete within 6
                                   months of the due
                                   date.
(b) Standard: Clinical            No annual volume    CMS requirements
 experience. We require an         required by the     are straighter
 annual volume for the following   OPTN. However, it   than OPTN policy
 types of transplant centers:      has definitions     for the purpose
 Heart, intestine, liver   for                 of monitoring
 & lung transplant centers--10     ``functionally      inactivity of
 transplants..                     inactive''          centers.
 Kidney transplant         centers:
 centers--at least 3               No
 transplants..                     transplants
 No annual volume          performed in 3
 requirement for heart-lung, and   months in the
 pancreas centers, and centers     case of kidney,
 that primarily perform            liver, & heart
 pediatric transplants..           transplant
                                   programs.
                                   No
                                   transplants
                                   performed in 6
                                   months in the
                                   case of pancreas
                                   & lung programs.

[[Page 15202]]

 
(c) Standard: Outcome measures..                      CMS adopts the
 We will review outcomes  ..................   OPTN bylaws to
 for all transplants performed    ..................   the extent that
 at a center, including outcomes  ..................   the outcome
 for living donor transplants,    ..................   measure standards
 if applicable. Except for lung   ..................   and the OPTN
 transplants, CMS will review     ..................   policies for
 adult and pediatric outcomes     ..................   survival rate
 separately when a center         OPTN Bylaw           criteria &
 requests Medicare approval to     Appendix B          outcome
 perform pediatric transplants.    Attachment          methodology are
 A center's (risk-         Survival Rates.     essentially the
 adjusted) expected 1-year         While the   same in the
 patient survival and 1-year       precise numerical   assessment of a
 graft survival will be compared   criteria may be     center's
 to its observed 1-year patient    selected by the     outcomes.
 survival and 1-year graft         Membership &        However, OPTN
 survival, based on the            Professional        uses the survival
 following non-compliance          service             outcomes as flags
 thresholds:.                      Committee, the      for further
 O - E >3...............   initial criteria    investigation
 O/E >1.5...............   employed to         while CMS uses
 1-sided p <0.05........   identify programs   them as criteria
                                   with low patient/   to make approval
                                   graft survival      & re-approval
                                   rates will          determinations.
                                   include the        Compliance with
                                   following           the OPTN's
                                   findings:.          survival rate
                                   O - E >3.   criteria is not
                                   O/E >1.5.   required for
                                   1-sided p   initial approval
                                   <0.05..             of a new
                                                       transplant
                                                       program as an
                                                       OPTN member. The
                                                       OPTN grants
                                                       conditional
                                                       approval to new
                                                       transplant
                                                       programs, which
                                                       gives the new
                                                       transplant
                                                       program 3 years
                                                       to comply with
                                                       the OPTN
                                                       requirements.
(d) Exceptions. No outcome
 requirements for:
 Heart-lung transplant
 centers..
 Intestinal transplant
 centers..
 Pancreas transplant
 centers..
Sec.   482.82 Condition of
 participation: Data submission,
 clinical experience, and
 outcome requirements for RE-
 APPROVAL of transplant centers.
(a) Standard: Data submission.    See Initial         See Initial
 No later than 90 days after the   Approval.           Approval.
 due date established by the
 OPTN, a transplant center must
 submit to the OPTN 95 percent
 of the required data
 submissions on all transplants
 (deceased and living donor) it
 has performed over the 3-year
 approval period.
(b) Standard: Clinical            See Initial         See Initial
 experience. We require an         Approval.           Approval.
 annual volume for the following
 types of transplant centers:
     Heart, intestine,
     kidney, liver & lung
     transplant centers--10
     transplants.
     No annual volume
     requirement for heart-
     lung, and pancreas centers,
     and centers that primarily
     perform pediatric
     transplants.
(c) Standard: Outcome measures..  See Initial         See Initial
                                   Approval.           Approval.
 We will review outcomes
 for all transplants performed
 at a center, including outcomes
 for living donor transplants,
 if applicable. Except for lung
 transplants, CMS will review
 adult and pediatric outcomes
 separately when a center
 requests Medicare approval to
 perform pediatric transplants.
 A center's (risk-
 adjusted) expected 1-year
 patient survival and 1-year
 graft survival will be compared
 to its observed 1-year patient
 survival and 1-year graft
 survival, based on the
 following non-compliance
 thresholds:
 O - E >3.
 O/E >1.5.
 1-sided p <0.05.
(d) Exceptions. No outcome
 requirements for:
     Heart-lung
     transplant centers.
     Intestinal
     transplant centers.
     Pancreas transplant
     centers.
Sec.   482.90 Condition of        Sec.   121.8        CMS requirements
 participation: Patient and        Allocation of       complement OPTN
 living donor selection.           Organs.             policies.
(a) Standard: Patient selection.  The OPTN has wait
 Patient selection criteria        list policies for
 must:                             the purpose of
                                   organ allocation.
     Assure fair and non-
     discriminatory distribution
     of organs.
     Include a
     psychosocial evaluation.

[[Page 15203]]

 
     Include
     documentation in the
     patient's medical record
     that the candidate's blood
     type has been determined on
     at least two separate
     occasions.
     Include
     documentation in the
     patient's medical record of
     the patient selection
     criteria used.
(b) Standard: Living donor                            No comparable OPTN
 selection. The living donor                           policy/bylaw.
 selection criteria must be
 consistent with the general
 principles of medical ethics.
Transplant centers must:
     Ensure that a
     prospective living donor
     receives a medical &
     Psychosocial evaluation
     prior to donation.
     Document in the
     living donor's medical
     records the living donor's
     suitability for donation.
     Document that the
     living donor has given
     informed consent, as
     required.
Sec.   482.92 Condition of
 participation: Organ recovery
 and receipt.
 Written protocols for--
 deceased organ recovery, organ
 receipt, and living donor
 transplantation to validate
 donor-recipient matching of
 blood types and other vital
 information.
 The transplanting
 surgeon at the transplant
 center responsible for ensuring
 medical suitability of donor
 organs for transplantation into
 the intended recipient.
(a) Standard: Organ recovery.     Policy 3.1 Organ    CMS requirements
When an intended transplant        Distribution:       complement OPTN
 recipient is known, the           Definitions.        policies.
 transplant center's organ        3.1.2 Transplant
 recovery team must review and     Center--The
 compare donor-data with the       transplanting
 recipient blood type and other    surgeon is
 vital information before organ    responsible for
 recovery takes place.             ensuring medical
                                   suitability of
                                   donor organ for
                                   transplantation
                                   into the
                                   potential
                                   recipient,
                                   including
                                   compatibility of
                                   donor and
                                   candidate by ABO
                                   blood type.
(b) Standard: Organ receipt.      Policy 3.1 Organ    CMS requirements
                                   Distribution:       complement OPTN
                                   Definitions.        policies.
 When an organ arrives    3.1.2 Transplant
 at the center, the                Center--Upon
 transplanting surgeon and at      receipt of an
 least one licensed health care    organ, prior to
 professional must verify that     implantation, the
 the donor's blood type and        transplant center
 other vital information is        is responsible
 compatible with transplantation   for verifying the
 of the intended recipient prior   recorded donor
 to transplantation.               ABO with the
                                   recorded ABO of
                                   the intended
                                   recipient.
(c) Standard: Living donor        ..................  No comparable OPTN
 transplantation.                                      policy/bylaw.
 If a center performs
 living donor transplants, the
 transplanting surgeon and at
 least one licensed health care
 professional at the transplant
 center must verify that the
 donor's blood type and other
 vital information is compatible
 with transplantation of the
 intended recipient immediately
 before the removal of the donor
 organ(s) and, if applicable,
 prior to the removal of the
 recipient's organ(s).
Sec.   482.94 Condition of        ..................  No comparable OPTN
 participation: Patient and                            policy/bylaw.
 living donor management.
 Transplant center must
 have written patient management
 policies and patient care
 planning for the pre-
 transplant, transplant, and
 discharge phases of
 transplantation.
 Center must have
 written donor management
 policies for the donor
 evaluation, donation, and
 discharge phases of living
 organ donation if it performs
 living donor transplants.
(a) Standard: Patient and living  ..................  No comparable OPTN
 donor care..                                          policy/bylaw.
Each transplant patient and/or
 living donor is under the care
 of a multidisciplinary patient
 care team coordinated by a
 physician throughout
 transplantation or donation.

[[Page 15204]]

 
(b) Standard: Waitlist            OPTN Policies       CMS Requirements
 management. Transplant centers    3.2.3.1, 3.6.6.     complement OPTN
 must keep their waitlists up to   Require     policies.
 date, including:                  transplant
 Updating waitlist         centers to
 patients' clinical information    immediately
 on an ongoing basis..             remove transplant
 Removing patients from    candidates that
 the center's waitlist if a        have received a
 patient receives a transplant     transplant from a
 or dies, or if there is any       deceased donor,
 other reason why the patient      or have died
 should no longer be on a          while awaiting a
 center's waitlist..               transplant, from
 Notifying the OPTN no     the center's
 later than 24 hours after a       waitlist and from
 patient's removal from the        the UNOS Patient
 center's waitlist..               Waiting List and
                                   to notify UNOS
                                   within 24 hours
                                   of such removal.
(c) Standard: Patient records.    OPTN Bylaw          CMS adopts OPTN
 Transplant centers must           Appendix B.         bylaw for the
 maintain up-to-date and          II.C.10 Transplant   most part.
 accurate patient management       Programs: Patient
 records for each patient who      Notification.
 receives an evaluation for       Transplant
 placement on a center's           programs must
 waitlist and who is admitted      notify patients
 for organ transplantation. This   in writing:.
 includes notification to         (i) within ten
 patient (and patient's usual      business days (a)
 dialysis facility if patient is   of the patient's
 a kidney patient) of:             being placed on
 Patient's placement on    the UNOS Patient
 the center's waitlist; the        Waiting List
 center's decision not to place    including the
 the patient on its waitlist; or   date the patient
 the center's inability to make    was listed, or
 a determination regarding the     (b) of completion
 patient's placement on its        of the patient's
 waitlist because further          evaluation as a
 clinical testing or               candidate for
 documentation is needed..         transplantation,
 Removal from waitlist     that the
 for reasons other than            evaluation has
 transplantation or death within   been completed
 10 days..                         and that the
 Patient records must      patient will not
 contain documentation of:.        be placed on the
 Multidisciplinary         UNOS Patient
 patient care planning during      Waiting List at
 the pre-transplant period..       this time,
 Multidisciplinary         whichever is
 discharge planning for post-      applicable; and.
 transplant care..                (ii) within ten
                                   business days of
                                   removal from the
                                   UNOS Patient
                                   Waiting List as a
                                   transplant
                                   candidate for
                                   reasons other
                                   than
                                   transplantation
                                   or death that the
                                   patient has been
                                   removed from the
                                   Waiting List. The
                                   transplant
                                   program must
                                   maintain..
(d) Standard: Social services.    Sec.   121.9(a)     The OPTN bylaw
The transplant center must make    Designated          does not define
 available social services,        Transplant          qualification of
 furnished by qualified social     Program             a qualified
 workers, to transplant            Requirements        social worker.
 patients, living donors, and     OPTN Bylaw           CMS requirement
 their families. Definitions for   Appendix B,         complement OPTN
 a qualified social worker         Attachment I,       bylaw.
 included..                        III.C.15
                                   Transplant
                                   Programs: Social
                                   Support--Psychiat
                                   ric and social
                                   support services
                                   must be available
                                   in transplant
                                   programs approved
                                   under
                                   121.9(a)(2)..
(e) Standard: Nutritional         ..................  No comparable OPTN
 services. Nutritional                                 policy/bylaw.
 assessments and diet counseling
 services furnished by a
 qualified dietitian must be
 available to all transplant
 patients and living donors.
 Definitions for a qualified
 dietitian included.
Sec.   482.96 Condition of        ..................  No comparable OPTN
 participation: Quality                                policy/bylaw.
 assessment and performance
 improvement (QAPI).
A transplant center must have a
 data-driven QAPI programs to
 monitor & evaluate performance
 of all transplantation
 services.
Sec.   482.98 Condition of
 participation: Human resources.
(a) Standard: Director of a
 transplant center.
Transplant center must be under
 the general supervision of a
 qualified transplant surgeon or
 a qualified physician-director.

[[Page 15205]]

 
(b) Standard: Transplant surgeon  OPTN Bylaw          The OPTN bylaw for
 and physician.                    Appendix B          credentials is
 Transplant center must    defines the         too detailed for
 identify to the OPTN a primary    credential of a     adoption in
 transplant surgeon and a          qualified           regulation.
 transplant physician with the     transplant         CMS requirement
 appropriate training and          surgeon and         for ``immediate
 experience to provide             physician in 15     availability of
 transplantation services, who     pages.              the primary
 are immediately available to     Each transplant      transplant
 provide transplantation           center designated   surgeon &
 services when an organ is         under 42 CFR        physician''
 offered for transplantation..     121.9(a)(2) must    complement OPTN's
                                   have on-site a      ``on-site''
                                   qualified           bylaw.
                                   transplant
                                   surgeon.
 Transplant surgeon is
 responsible for providing
 surgical services related to
 transplantation.
 Transplant physician is
 responsible for providing and
 coordinating transplantation
 care.
(c) Standard: Clinical            OPTN Bylaw          CMS requirement
 transplant coordinator. The       Appendix B:         complement the
 transplant center must have a     Requirement for a   OPTN bylaw.
 qualified clinical transplant     Clinical
 coordinator to ensure the         Transplant
 continuity of care of patients    Coordinator with
 and living donors throughout      defined
 transplantation and donation.     responsibilities.
(d) Standard: Independent living
 donor advocate of living donor
 advocate team. The transplant
 center that performs living
 donor transplants must identify
 either an independent living
 donor advocate or an
 independent living donor
 advocate team to ensure
 protection of the rights of
 living donors and prospective
 living donors.
(e) Standard: Transplant team.    Sec.   121.9(a)     CMS requirements
 The transplant center must        Designated          complement Part
 identify a multidisciplinary      Transplant          121 requirements
 transplant team (composed of      Program             and OPTN bylaw.
 individuals from medicine,        Requirements.
 nursing, nutrition, social       OPTN Bylaw
 services, transplant              Appendix B
 coordination, and pharmacology)   Attachment I..
 and describe the                 Collaborative
 responsibilities of each member   Support--Transpla
 of the team.                      nt programs
                                   approved under
                                   121.9(a)(2) must
                                   show evidence of
                                   collaborative
                                   involvement with
                                   experts in the
                                   field of
                                   hepatology,
                                   radiology,
                                   pediatrics,
                                   infectious
                                   disease,
                                   nephrology with
                                   dialysis
                                   capability,
                                   pulmonary
                                   medicine with
                                   respiratory
                                   therapy support,
                                   pathology,
                                   immunology,
                                   anesthesiology,
                                   physical therapy
                                   and
                                   rehabilitation
                                   medicine.
(f) Standard: Resource            Sec.   121.9(a)     CMS adopts the
 commitment. The transplant        Designated          Part 121
 center must demonstrate           Transplant          requirements and
 availability of expertise in      Program             OPTN bylaw.
 internal medicine, surgery,       Requirements.
 anesthesiology, immunology,      Bylaws Appendix B
 infectious disease control,       Attachment I..
 pathology, radiology, and blood  Transplant
 banking as related to the         Programs--Ancilla
 provision of transplantation      ry services--
 services.                         Transplant
                                   programs approved
                                   under 121.9(a)(2)
                                   must have
                                   immediate access
                                   to sophisticated
                                   microbiology,
                                   clinical
                                   chemistry, tissue
                                   typing, bloodbank
                                   support,
                                   radiology
                                   services, as well
                                   as the facilities
                                   required for
                                   monitoring
                                   immunosuppressive
                                   drugs.
Sec.   482.100 Condition of       Sec.   121.9(a)     CMS requirement
 participation: Organ              Designated          complement the
 procurement.                      Transplant          OPTN bylaw
 Transplant center must    Program             because the OPTN
 ensure that transplant hospital   Requirements.       bylaw does not
 has written agreement (with      Bylaws Appendix B    require
 delineated responsibilities for   Attachment I A      transplant
 both parties) with an OPO         transplant          centers to notify
 designated by the Secretary.      program approved    the OPTN or CMS
                                   under 121.9(a)(2)   when an agreement
                                   must have letters   with an OPO is
                                   of agreement or     terminated.
                                   contracts with an
                                   OPO.
Sec.   482.102 Condition of       ..................  No comparable OPTN
 participation: Patient and                            policy/bylaw.
 living donor rights.
 In addition to meeting
 the requirements at Sec.
 482.13, the transplant center
 must protect and promote each
 transplant patient's and living
 donor's rights.
(a) Standard: Informed consent    ..................  No comparable OPTN
 for transplant patients.                              policy/bylaw.
 Transplant centers must
 have written policies for the
 informed consent process.
 Each patient will be
 informed about:
    --The evaluation process;
    --The surgical procedure;
    --Alternative treatments;

[[Page 15206]]

 
    --Potential medical or
     psychosocial risks;
    --National & center-specific
     outcomes from the most
     recent SRTR center-specific
     report, including (but not
     limited to) the transplant
     center's observed and
     expected 1-year patient and
     graft survival, national 1-
     year patient and graft
     survival, and notification
     about all Medicare outcome
     requirements not being met
     by the transplant center;
    --Organ donor risk factors
     that could affect the
     success of the graft or
     health of the patient;
    --His or her right to refuse
     transplantation;
    --The fact that if his or
     her transplant is not
     provided in a Medicare-
     approved transplant center
     it could affect the
     transplant recipient's
     ability to have his or her
     immunosuppressive drugs
     paid under Medicare Part B.
(b) Standard: Informed consent    ..................  No comparable OPTN
 for living donors.                                    policy/bylaw.
 Transplant centers must                      CMS adopts many of
 have written policies for the                         the informed
 informed consent process..                            consent elements
 Each living donor will                        contained in the
 be informed about:.                                   Secretary's
                                                       Advisory
                                                       Committee on
                                                       Transplantation
                                                       (ACOT)
                                                       Recommendations.
    --The fact that
     communication between the
     donor & the transplant
     center will remain
     confidential, in accordance
     with the requirements at 45
     CFR parts 160 & 164.
    --The evaluation process.
    --The surgical procedure,
     including post-op
     treatment.
    --The availability of
     alternative treatments for
     the transplant recipient.
    --The potential medical or
     psychosocial risks to the
     donor.
    --The national & center-
     specific outcomes for
     recipients & living donors
     as data are available.
    --The possibility that
     future health problems
     related to the donation may
     not be covered by the
     donor's insurance, and that
     the donor's ability to
     obtain health, disability,
     or life insurance may be
     affected.
    --The donor's right to opt
     out of donation at any time
     during the donation
     process.
    --The fact that if his or
     her transplant is not
     provided in a Medicare-
     approved transplant center
     it could affect the
     transplant recipient's
     ability to have his or her
     immunosuppressive drugs
     paid under Medicare Part B.

[[Page 15207]]

 
(c) Standard: Notification to     Sec.   121.9        CMS adopts Part
 patients.                         Designated          121 and OPTN
Transplant centers must notify     Transplant          bylaws.
 patients placed on the center's   Program
 waiting list of information       Requirements.
 about the center that could      (a) To receive
 impact the patient's ability to   organs for
 receive a transplant should an    transplantation,
 organ become available, and       a transplant
 what procedures are in place to   program approved
 ensure the availability of a      under 121.9(a)(2)
 transplant team:.                 agrees to
--The fact the center is served    promptly notify
 by a single transplant surgeon    OPTN & patients
 or physician, the potential       awaiting
 unavailability of the             transplantation
 transplant surgeon or             if it becomes
 physician, and whether or not     inactive.
 the center has a mechanism to    OPTN Bylaws
 provide an alternative            Appendix B
 transplant surgeon or             Attachment I--
 transplant physician that meets   Criteria for
 the hospital's credentialing      Institutional
 policies..                        Membership.
 At least 30 days before  III.C Transplant
 a center's Medicare approval is   programs--A
 terminated, whether voluntarily   transplant
 or involuntarily, the center      program served by
 must inform:.                     a single surgeon
--Patients on the waiting list &   or physician
 provide assistance to waiting     shall inform
 list patients who choose to       patients of this
 transfer to the waiting list of   fact and
 another Medicare-approved         potential
 center without loss of time       unavailability of
 accrued on the waiting list;      1 or both of
 and.                              these individuals
                                   during the year.
                                  OPTN Bylaws,
                                   Appendix B..
                                  VI. Change in
                                   Program Status..
                                  When a transplant
                                   program is
                                   voluntarily or
                                   involuntarily
                                   inactivated,
                                   waitlist patients
                                   may retain
                                   existing waiting
                                   time and continue
                                   to accrue waiting
                                   time. Accrued
                                   waiting time may
                                   be transferred to
                                   the patient's
                                   credit when s(he)
                                   is listed with a
                                   new program.
    --Medicare beneficiaries on
     the center's waiting list
     that Medicare will no
     longer pay for transplants
     performed at the center
     after the effective date of
     the center's termination of
     approval.
 As soon as possible
 prior to a transplant center's
 inactivation, the center must
 inform patients on the center's
 waiting list and, as directed
 by the Secretary, provide
 assistance to waiting list
 patients who choose to transfer
 to the waiting list of another
 Medicare-approved transplant
 center without loss of time
 accrued on the waiting list.
Sec.   482.104 Condition of       ..................  No comparable Part
 participation: Additional                             121 requirements
 requirements for kidney                               or OPTN policy/
 transplant centers.                                   bylaw for kidney
                                                       transplant
                                                       centers.
(a) Standard: End stage renal
 disease (ESRD).
 Kidney transplant
 centers must furnish directly
 transplantation & other medical
 & surgical specialty services
 required for the care of ESRD
 patients.
(b) Standard: Dialysis services.
 Kidney transplant
 centers must furnish inpatient
 dialysis services directly or
 under arrangement.
(c) Standard: Participation in
 network activities.
 Kidney transplant
 centers must cooperate with the
 ESRD Network designated for its
 geographical area, in
 fulfilling the terms of the
 Network's current statement of
 work.
No comparable CMS requirements..  Bylaws Appendix B-- Relocation and
                                   Criteria for        transfer of
                                   Institutional       established
                                   Membership.         programs is not
                                                       addressed in CMS
                                                       requirements.
                                  III.E Relocation
                                   and Transfer of
                                   Established
                                   Programs.
No comparable CMS requirements..  Part 121.8          The OPTN policies
                                   Allocation          are all organ
                                   requirements of     allocation/
                                   Organs.             acceptance
                                  OPTN Policy 3.0      policies.
                                   Organ
                                   Distribution..
                                  3.3 Acceptance
                                   Criteria.
                                  3.4 Organ
                                   Procurement,
                                   distribution, and
                                   alternative
                                   systems for organ
                                   distribution or
                                   allocation.
                                  3.9 Allocation
                                   System for Organs
                                   Not Specifically
                                   Addressed.

[[Page 15208]]

 
                                  3.10 Back-up for
                                   Inactive
                                   Transplant
                                   Programs.
                                  3.11 Intestinal
                                   Organ Allocation.
                                  Appendix to Policy
                                   3.0.
                                  A. HLA Antigen
                                   Values and Split
                                   Equivalences.
                                  C. Resolving
                                   Discrepant Donor
                                   and Recipient HLA
                                   Typing Results in
                                   the OPTN Database.
                                  Policy 4.0
                                   Acquired Immune
                                   Deficiency
                                   Syndrome (AIDS)
                                   and Human
                                   Pituitary
                                   Deceived Growth
                                   Hormone (HPDGH)
                                   and Human T-
                                   Lymphotropic
                                   Virus Type I
                                   (HTLV-I).
                                  Policy 6.0
                                   Transplantation
                                   of Non-Resident
                                   Aliens.
Sec.   488.61 Special procedures  Sec.                OPTN policies and
 for approval and re-approval of   121.10(c)(1)(2)     bylaws are
 organ transplant centers.         Enforcement of      voluntary, until
 Survey, certification,    OPTN rules.         approved (i.e.,
 and enforcement procedures at    Sanctions for        codified) by the
 42 CFR part 488, subpart A,       violations of non-  Secretary. At
 including the periodic review     mandatory           this time, the
 of compliance and approval        policies or         Secretary has not
 contained in Sec.   488.20..      mandatory           approved or
 Transplant centers that   policies (w/o       published any
 meet all data submission,         approval from the   OPTN policies and
 clinical experience, outcome,     Secretary of        bylaws, except
 and process requirements will     DHHS) include:.     for data
 be approved for 3 years..         Warning,    submission
 Current Medicare-         letter of           requirements.
 approved centers will continue    admonition, or     For the first
 to be Medicare approved after     letter of           time, transplant
 submitting applications and       reprimand.          centers have the
 awaiting CMS's decision for                   same appeal
 approval..                        Probation..         rights as other
 At the end of 3-year      Member      Medicare
 approval period, CMS will         Not in Good         providers.
 review transplant center's data   Standing..
 to determine compliance with     Additional
 data submission, clinical         Sanctions (only
 experience and outcome            for violation of
 requirements at Sec.   482.82..   mandatory
 If a center is in         policies):.
 compliance with Sec.   482.82,   
 CMS may choose to review its      Suspension of
 compliance with the rest of the   member
 CoPs..                            privileges..
 A transplant center may  
 remain inactive and retain its    Termination of
 Medicare approval for a period    OPTN membership..
 not to exceed 12 months during   
 the 3-year approval cycle..       Termination of
 Centers that have lost    Status as
 their Medicare approval may       Designated
 seek re-entry into the Medicare   Transplant
 program at any time, and the      Program,
 center must:.                     Termination of
                                   Participation in
                                   Medicare/
                                   Medicaid,
                                   Termination of
                                   Reimbursement
                                   under Medicare/
                                   Medicaid.
                                  The 3 additional
                                   sanctions can
                                   only be imposed
                                   by the Secretary.
                                  Sec.   121.10(c)
                                   Sanctions can
                                   also be imposed
                                   for violations of
                                   Part 121,
                                   including its
                                   data submission
                                   requirements, and
                                   when the
                                   Secretary
                                   determines that
                                   the public health
                                   or patient safety
                                   is at risk.
    (1) Request initial
     approval;
    (2) Comply with the initial
     approval requirements; and
    (3) Submit a report to CMS
     documenting any changes or
     corrective actions taken by
     the center as a result of
     the loss of its Medicare
     approval status.
    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..
     The definition of
     ``provider'' is amended by
     adding ``transplant
     center'' after ``hospital''
     the first time it appears..
------------------------------------------------------------------------

CMS Oversight and OPTN Policies

    Some commenters voiced their opinions about our oversight of 
transplant centers in comparison to OPTN oversight of its transplant 
hospital members.
    Comment: Some commenters stated their appreciation that the 
proposed rule is congruent with OPTN policies and bylaws, because OPTN 
policies and bylaws were developed through a consensus process with 
broad participation by the transplant community. Commenters pointed out 
that the rule sets consistent and unified standards and provides an 
established infrastructure for performance monitoring and review of 
transplant centers.
    Response: The OPTN's primary responsibilities are to ensure the 
effectiveness, efficiency, and equity of

[[Page 15209]]

organ allocation; increase the supply of transplantable organs; collect 
and disburse data; and designate transplant programs. We are 
responsible for establishing minimum standards to protect patient 
health and safety, and for implementing oversight mechanisms to ensure 
that transplant centers provide quality transplant and living donor 
care to Medicare beneficiaries through the development of health and 
safety requirements. In developing this rule, we worked closely with 
HRSA, which oversees the OPTN and SRTR, to ensure consistency and 
minimize the burden on transplant centers where possible.
    Comment: A commenter requested that we limit our role to 
reimbursement of clinical services.
    Response: As a health care regulatory agency and a prudent health 
care purchaser, our responsibility cannot be limited to reimbursement. 
The Secretary has the statutory authority and responsibility to protect 
patient health and safety and to ensure that high quality care is 
provided to patients.
    Comment: Many commenters stated that the OPTN oversight process and 
our approval and re-approval process would create an inconsistent and 
duplicative mechanism in the oversight of transplant centers. The 
commenters stated that we should collaborate with the OPTN to 
streamline the two processes into one unified consistent process, but 
with more reliance on OPTN oversight. One public commenter stated that 
CMS should consider termination of a center only if the OPTN Board 
reports to the Secretary that it has made a final decision to take 
adverse action against the center. A peer reviewer was concerned that 
the collegial relationship between OPTN and the transplant centers 
might be jeopardized by codification of some of the OPTN requirements.
    Response: We understand the commenters' concerns. However, for the 
most part, we and the OPTN have different roles vis-[aacute]-vis 
transplant centers. For example, when surveying transplant centers for 
compliance with the CoPs in this final rule, we will focus on 
protections for patient health and safety. When the OPTN surveys (or 
performs desk audits of) transplant centers, it focuses on compliance 
with candidate listing and delisting, data submission, and its patient 
notification policies and verifies that the designated physician and 
surgeon are the same individuals approved by the OPTN. The degree of 
authority to act in the event of non-compliance also differs. The OPTN 
generally takes a collegial approach and assists centers in improving 
their performance, while we generally take a regulatory approach which 
sometimes may lead to termination of the Medicare agreement with 
providers. However, compliance with the OPTN's policies will facilitate 
transplant centers' compliance with the requirements in this final 
rule. Therefore, the OPTN will continue to play a consultative role 
with transplant centers to assist them in complying with Medicare 
requirements. We believe the collegial relationship between the OPTN 
and the transplant centers may be enhanced and strengthened rather than 
compromised.
    Comment: Many commenters stated that the OPTN oversight process is 
vigorous and effective and that the OPTN should have full oversight of 
transplant centers to avoid duplicative efforts. The commenters cited 
42 CFR part 121 as the regulation governing the operation of the OPTN 
and stated that the OPTN has legally binding rules enforceable on 
transplant centers.
    Other commenters noted that the OPTN already surveys heart and 
liver programs once every 3 years. The commenters recommended that the 
OPTN be recognized as the accrediting body to audit and survey centers 
periodically based on its expertise in dealing with the complexity of 
transplantation. A commenter recommended that we review a center for 
potential termination from the Medicare program only if the Secretary 
has been notified of a final decision of the OPTN Board to take an 
adverse action against the center. The commenters stated that reviews 
or surveys conducted by an inexperienced CMS designee would burden 
centers and lead to misinterpretation of OPTN policies and CMS 
regulations, which could cause confusion and loss of Medicare approval.
    Response: The commenters are correct that 42 CFR part 121 governs 
the operation of the OPTN, which establishes policies for transplant 
hospital members. OPTN policies are enforceable only when they have 
been incorporated into regulations by the Department. However, with the 
exception of the OPTN data submission requirements, OPTN policies have 
not been incorporated by the Department. Therefore, if the OPTN 
determines that removal of a member's designation as a transplant 
hospital is warranted for reasons of non-compliance with other OPTN 
policies, with the final rule governing the operation of the OPTN (42 
CFR part 121), or because of a threat to public health and safety, the 
OPTN will recommend to the Secretary that the member's designation be 
revoked. The OPTN has made this recommendation on only two occasions.
    We have an obligation to oversee transplant centers serving 
Medicare beneficiaries, and we do not have the statutory authority to 
delegate oversight responsibilities to the OPTN. In our view, the OPTN 
oversight approach is a complement to the Medicare regulatory 
authority. Once the final rule becomes effective, and before conducting 
surveys, our surveyors will be trained in applicable OPTN policies for 
transplant centers.
    Comment: A commenter recommended that the Secretary take action to 
expand the role of the OPTN relative to oversight of living donors.
    Response: The commenter's recommendation falls outside the scope of 
this final rule. We will forward this recommendation to the Secretary 
for consideration.
    Comment: A commenter stated that despite the fact that the OPTN 
requires transplant programs to abide by OPTN policies and bylaws, we 
should not codify the OPTN policies and bylaws as regulatory language. 
One commenter stated that the relatively fluid OPTN policies and bylaws 
would allow the incorporation of future changes in transplant practice 
more quickly.
    Response: The requirements in this final rule are intended to be 
broadly applicable to transplant centers over a long period of time. 
OPTN policies or elements of OPTN policies that we have included in 
this final rule conform to this intent. We understand that many OPTN 
policies, particularly organ allocation, transplant surgeon and 
transplant physician credentials, and criteria for listing and de-
listing transplant candidates are subject to rapid changes as 
transplant medicine advances. Therefore, we did not include such 
policies in this final rule.
    Comment: Some commenters raised confidentiality concerns regarding 
the sharing of data between the OPTN and CMS under applicable laws and 
regulations protecting the peer review process. One commenter suggested 
adding language to state that the regulation is not intended to affect 
the confidentiality of the process in any manner.
    Response: We understand the commenters' concerns about the 
confidentiality of data shared between the OPTN and CMS. However, under 
reporting requirements set forth in 42 CFR 121.11(b)(1)(iii), the OPTN 
and the SRTR are required to provide to CMS any data that we request, 
as appropriate. Nonetheless, it is not our intention to disrupt the 
OPTN confidential peer review process. We will obtain only the

[[Page 15210]]

OPTN data that is necessary for our oversight of transplant centers.
    Comment: One commenter suggested that section 1865 of the Act and 
regulations at 42 CFR part 488 mean that only CMS's designated national 
accrediting organizations are eligible for deeming authority for 
transplant centers. The commenter further stated that organizations 
that accredit both hospitals and transplant centers are in the best 
position to ensure consistent quality oversight and avoid fragmented 
survey arrangements.
    Response: We will consider applications from any national 
accrediting organization for deeming authority for initial approval and 
re-approval for any of the extra-renal transplant centers. We believe 
that we have the statutory authority to permit national accrediting 
organizations to accredit most transplant centers as ``facilities,'' 
pursuant to paragraph 1865(b)(4) of the Act, with the exception of 
kidney transplant centers. As discussed previously, section 1864 of the 
Act authorizes the use of State agencies to determine providers' 
compliance with the CoPs. A national accreditation program may apply 
for deeming authority for the providers that are specifically listed in 
Sec.  488.6. Since ``transplant centers'' are not specifically 
identified in Sec.  488.6, this final rule inserts the language 
``transplant centers, except for kidney transplant centers'' in Sec.  
488.6(a) with the list of providers eligible for deeming authority. 
Kidney transplant centers are specifically excluded because they are 
not eligible for deeming authority by statute. (See sections 1864 and 
1865(b)(4) of the Act.)

Special Requirements for Transplant Centers (Proposed Sec.  482.68)

    We proposed that a transplant center located within a hospital that 
has a Medicare provider agreement must meet the CoPs specified in Sec.  
482.72 through Sec.  482.104 in order to be granted our approval to 
provide transplant services.
    We proposed that the CoPs specified in Sec.  482.72 through Sec.  
482.104 would apply to all heart, heart-lung, intestine, kidney, liver, 
lung, and pancreas transplant centers, unless specified otherwise.
    We also proposed that transplant centers seeking Medicare approval 
must meet the hospital CoPs specified in Sec.  482.1 through Sec.  
482.57.
    We received no comments on this section of the proposed regulation 
and are finalizing it as proposed.

Definitions (Proposed Sec.  482.70)

    We proposed definitions for ``transplant hospital,'' ``transplant 
program,'' and ``transplant center'' to clarify the usage of these 
terms throughout the regulation.
    We proposed deleting the definitions for ``histocompatibility 
testing,'' ``ESRD Network,'' ``network organization,'' ``organ 
procurement,'' ``renal transplantation center,'' ``transplantation 
service,'' and ``transplantation surgeon'' contained in Sec.  405.2102, 
as these terms are no longer used in the section.
    We proposed including the definitions for ``ESRD,'' ``ESRD 
network,'' and ``network organization'' from Sec.  405.2102 in this 
final rule to emphasize the distinct statutory authority and 
requirements that kidney transplant centers have to meet and to clarify 
the use of the terms in the proposed CoPs for transplant centers.
    We proposed adding definitions for ``adverse event,'' ``heart-lung 
transplant center,'' ``pancreas transplant center,'' and ``intestinal 
transplant center.''
    This final rule includes all definitions related to ESRD Network 
programs from 42 CFR part 405, subpart U, Sec.  405.2102, as well as 
Sec. Sec.  405.2110 through 2114. We note that in the proposed rule we 
incorrectly stated that our proposed definition for ``adverse event'' 
was derived from the JCAHO's definition of ``adverse event.'' In fact, 
JCAHO has a definition for ``sentinel event'' but not ``adverse 
event.'' Additionally, we have made a change to the definition of 
``adverse event'' for clarification purposes. The proposed definition 
listed two examples of adverse events related to living donors: 
``living donor death due to mismanagement of the donor'' and 
``avoidable loss of a healthy living donor.'' We have replaced these 
two examples with ``serious medical complications or death caused by 
living donation'' to clarify that the death of any living donor or a 
living donor's serious medical complications caused by living donation 
should be investigated as an adverse event. Following are summaries of 
the comments we received and our responses.
    Comment: One commenter applauded our efforts to standardize 
definitions for transplant hospitals for the purpose of improving 
communication. The commenter noted that JCAHO developed a Patient 
Safety Event Taxonomy in response to the lack of agreement on 
definitions regarding medical errors. The commenter suggested that the 
adoption of the Patient Safety Event Taxonomy developed by the JCAHO in 
the quality assessment and performance improvement (QAPI) CoP would 
decrease confusion, improve patient safety, and promote quality.
    Response: A Patient Safety Event Taxonomy is a system of 
classifying adverse events at hospitals or other providers of health 
care. Thus, the Taxonomy is a ``language'' in which providers can 
report adverse events. One of the JCAHO's current initiatives is to 
``promote using health information technology to improve patient safety 
reporting, data analysis and learning from errors, and to promote a 
national reporting system for adverse events through the use of 
standardized patient safety taxonomy and ontology.'' Although the final 
rule provides a general definition for an ``adverse event'' in 
transplantation, it does not attempt to classify all possible adverse 
events in health care or transplantation. The Patient Safety Event 
Taxonomy classifies all health care events, not just those related to 
transplantation. Incorporation of the Taxonomy into the QAPI CoP would 
be inappropriate because it falls outside the scope of this rule. 
Therefore, we have not adopted the commenter's suggestion.
    Comment: One commenter noted that the term ``transplant center'' is 
commonly used interchangeably with the term ``transplant hospital.'' 
For this reason, the commenter stated that our proposal to use the term 
``transplant center'' interchangeably with ``transplant program'' is 
confusing and the commenter suggested the removal of the term 
``transplant center'' in the final rule.
    Response: Although we agree that these terms often are used 
interchangeably, we believe the transplant community understands our 
use of the term ``transplant center'' in this final rule. We do not 
believe it is necessary to make a change based on this comment.

Proposed General Requirements for Transplant Centers

Condition of Participation: OPTN Membership (Proposed Sec.  482.72)

    We proposed that a transplant center must be located in a 
transplant hospital that is a member of, and abides by the rules and 
requirements of, the OPTN, as set forth at Sec.  482.45(b)(1), and that 
are enforceable under 42 CFR 121.10.
    We proposed that no transplant hospital would be considered to be 
out of compliance with section 1138(a)(1)(B) of the Act (which requires 
participation in the OPTN) unless the Secretary gave the OPTN formal 
notice that he or she approved the decision to exclude the transplant 
hospital from the OPTN and notified the center in writing.

[[Page 15211]]

    We received no comments on this section of the proposed rule. 
Therefore, we are finalizing it as proposed.

Condition of Participation: Notification to CMS (Proposed Sec.  482.74)

    We proposed requiring each transplant center to notify us 
immediately of any significant changes related to the center's 
transplant program or any change that would otherwise alter specific 
elements in its application for approval or re-approval.
    We proposed that instances in which we should be notified would 
include, but not be limited to, changes in key staff members of the 
transplant team (such as the individual who has been designated to the 
OPTN as the center's primary transplant surgeon or physician) or a 
decrease in the center's volume or survival rate that could result in 
the center being out of compliance with Sec.  482.82.
    Note that in this final rule, we have added to this section two 
specific instances that must be reported to us immediately. First, a 
transplant center must notify us if the hospital in which it is located 
terminates its agreement with an OPO for recovery and receipt of 
organs. Further information about this requirement can be found in this 
preamble in our discussion of the CoP for organ procurement. Second, a 
transplant center must notify us if it becomes inactive. Further 
information about our requirements in regard to transplant center 
inactivity can be found in this preamble in our discussion of clinical 
experience requirements and special procedures for approval and re-
approval of organ transplant centers.
    For clarity, we have replaced the language stating that a 
transplant center must notify us of any change that would otherwise 
alter specific elements in its application for approval. Section 
482.100 of this final rule states that, ``a transplant center must 
notify CMS immediately of any significant changes related to the 
center's transplant program or changes that could affect its compliance 
with the conditions of participation.''
    Following are summaries of the comments we received and our 
responses.
    Comment: A number of commenters supported the requirement for 
transplant centers to notify us of significant changes that may affect 
their approved status. However, some commenters stated that the 
requirement would be redundant and burdensome because the OPTN already 
requires such notification.
    Response: The OPTN bylaws require transplant hospital members to 
notify the OPTN immediately if the hospital learns that its primary 
surgeon or primary physician plans to leave. The transplant hospital is 
required to submit to the OPTN the name of the replacement surgeon or 
physician, curriculum vitae, and documentation of credentials and 
qualification at least 30 days (if possible) prior to the departure of 
the individual being replaced.
    Although we have avoided duplicating OPTN policies in this final 
rule (unless we have done so deliberately so that we can enforce a 
requirement), in this instance, we believe a transplant center should 
inform us in addition to the OPTN so that we can actively monitor the 
situation to confirm that the departing surgeon or physician is 
replaced. We note that the current NCDs require Medicare-approved 
heart, liver, and lung centers to report such information to us.
    Comment: One commenter suggested that transplant centers should not 
be required to notify us of a significant decrease in volume or 
survival rates. The commenter stated that an unusually large number of 
early deaths may not significantly affect 1-year outcomes if the 
transplant center subsequently has increased volume with successful 
results. Furthermore, these outcomes will be reflected in the 
subsequent SRTR 1-year survival reports.
    Response: As one component of the active monitoring and oversight 
of transplant centers, we need to be made aware of any significant 
changes at transplant centers. However, the outcome requirements in 
this final rule are based on 1-year patient and graft survival as 
calculated and reported by the SRTR, meaning that there may be a 
considerable lapse of time before we have access to data from the SRTR 
indicating that a transplant center's outcomes have dropped 
significantly. Although we understand that a decrease in clinical 
experience (that is, volume) and survival rates within a short period 
of time does not necessarily signify a problem, we need to be aware of 
these changes so that we can determine whether they are meaningful, for 
example, whether a decrease in the number of transplants signals 
ongoing inactivity and whether a decrease in outcomes signals a 
significant problem.
    When notified by a transplant center of a significant change, we 
will assess the information to determine how to proceed. We may note 
the information (such as a change in staff) and take no further action, 
contact the center for more information, analyze the information in 
conjunction with HRSA and the OPTN, and/or conduct an on-site review of 
the center.
    We recognize that it may be challenging for centers to determine 
whether decreases in the volume and unadjusted survival rates would be 
significant enough to warrant reporting to CMS. Centers will not be 
required to independently decide what constitutes a significant change. 
Centers will receive guidance from CMS through interpretive guidelines 
and provider notifications as to what constitutes a significant enough 
decrease in clinical experience or survival rates to necessitate 
reporting. This guidance is under development.
    Interpretive guidelines provide guidance to Medicare surveyors and 
clarify the intent of regulations. Each provider type is surveyed in 
accordance with the appropriate protocols based on the substantive 
requirements in the statute and regulations to determine whether a 
citation of non-compliance is appropriate. A center will be deemed 
deficient if it fails to meet the requirements of the statute or 
regulations, which, in turn, are based on the surveyor's observations 
of the providers' performance or practices.
    The specific process that surveyors use for each type of provider 
or supplier is outlined in the CMS State Operations Manual. The State 
Operations Manual is publicly available under the ``Manuals'' section 
of the CMS Web site. Included in the appendices of the State Operations 
Manual are the Interpretive Guidelines (also known as ``Guidance to 
Surveyors'') for each type of provider or supplier. The Interpretive 
Guidelines interpret and clarify the Conditions and Standards that are 
outlined in statute and regulations. The Interpretive Guidelines merely 
define or explain the relevant statute and regulations and describe the 
specific elements that a surveyor will be reviewing and/or observing. 
The Interpretive guidelines do not impose any requirements that are not 
otherwise sets forth in statute or regulation.
    Implementation of the survey and certification process for 
transplant programs will follow this same process. CMS is developing 
revisions to the State Operations Manual and a separate appendix that 
will include the Interpretive Guidelines that will be used for 
surveyors of organ transplant programs. CMS will also be posting 
informational material on its Web site for providers that would like to 
request approval for their transplant program. We made no changes based 
on this comment.
    Comment: One commenter noted that there was no definition provided 
for the term ``immediately'' for purposes of

[[Page 15212]]

describing the time frame within which a transplant center must notify 
us of changes. Other commenters questioned the term ``significant 
changes'' and recommended that the definition should be limited to 
staff changes and adverse events.
    Response: We disagree that the scope of significant changes should 
be limited to staff changes and adverse events. As we said in our 
previous response, decreases in the number of transplants performed and 
in the number of positive outcomes are also significant changes.
    We will address the time frame within which a transplant center 
must notify us of any significant changes and the meaning of 
``significant changes'' in our interpretive guidelines for Medicare 
surveyors, as that medium permits a more thorough explanation of our 
expectations. Interpretive guidelines provide guidance to surveyors and 
serve to clarify and explain the intent of regulations. No changes were 
made based on this comment.
    Comment: One commenter inquired about the consequence of failure to 
comply with this requirement. The commenter stated that a good faith 
failure to comply should not constitute grounds for termination.
    Response: Notification to us is one of the conditions of 
participation required for Medicare-approved transplant centers. A 
center that fails to notify us of any significant changes as delineated 
in Sec.  482.74 would be considered non-compliant with the transplant 
conditions of participation and 42 CFR part 488, may be subject to 
investigation, and could ultimately have its transplant center approval 
revoked.
    Comment: One commenter asked for a CMS contact for notification of 
changes. A commenter suggested linking transplant centers' notification 
of changes to the appropriate accrediting organization so that further 
assessment of the situation can be conducted promptly.
    Response: At this time, we do not know whether we or a designee 
will survey transplant centers. Therefore, under this final rule, a 
transplant center must report a significant change to us. (See Sec.  
482.74.)
    Comment: A commenter asked how we will communicate the changes in 
primary surgeons and physicians to the OPTN, once notified by 
transplant centers of the change.
    Response: The OPTN policies that transplant centers must meet as 
OPTN members already require transplant centers to inform the OPTN of 
changes in primary surgeons and physicians immediately; therefore, 
there is no need for us to communicate such changes to the OPTN.

Condition of Participation: Pediatric Transplants (Proposed Sec.  
482.76)

    Children are eligible for Medicare on the basis of ESRD as follows: 
under section 226A of the Act, an insured worker's dependent child (as 
defined in regulations) who is medically determined to have ESRD is 
eligible for Medicare Part A and Part B. According to 42 CFR 408.13, a 
child is considered ``dependent'' if he or she is unmarried and is 
under the age of 22 or is between ages 22 and 26 and has been receiving 
at least one half of his or her support from the insured worker 
continuously since before attainment of age 22.
    Children are eligible for Medicare on the basis of disability as 
follows: (1) Under section 223(b) of the Act, individuals who have been 
entitled to Childhood Disability Benefits (CDB) under section 202(d) of 
the Act by reason of a disability (as defined in section 223(d) of the 
Act) for 24 months are entitled to Medicare Part A and Part B the 25th 
month of disability benefit entitlement. Section 202(d) restricts the 
first month of CDB entitlement to the month the child attains age 18. 
Therefore, the earliest month a CDB beneficiary can qualify for 
Medicare is the month he or she attains age 20; or (2) section 223 of 
the Act provides that any individual who is under age 65 and has the 
necessary Social Security work credits, as defined in section 223(c) of 
the Act, and is under a disability as defined in section 223(d) of the 
Act, is entitled to Medicare Parts A and B on the 25th month of 
disability benefit entitlement.
    In 2005, Medicare paid for 404 pediatric transplants of different 
organ types.
    We proposed that in order to be reimbursed for transplants 
performed on pediatric Medicare beneficiaries, a hospital that 
furnishes transplantation services to both adult and pediatric patients 
must seek separate Medicare approval to provide pediatric 
transplantation services.
    We also proposed retaining the statutory criteria found at section 
4009(b) of the Omnibus Budget Reconciliation Act (OBRA) 1987 (Pub. L. 
100-203) as an extra option for heart transplant centers that wish to 
become Medicare-approved to perform pediatric heart transplants. We did 
not reference this citation in the proposed rule as an oversight. We 
proposed that a center that wishes to become Medicare-approved to 
perform pediatric heart transplants may also be approved by meeting 
data submission, outcome, and process requirements in the final rule.
    We proposed that a center that performs 50 percent or more of its 
transplants on adult patients must be approved to perform adult 
transplants in order to be approved to perform pediatric transplants. 
For these centers, we proposed that a loss of Medicare approval to 
perform adult transplants, whether voluntary or involuntary, would 
result in a loss of the center's approval to perform pediatric 
transplants. We also proposed that a loss of Medicare approval to 
perform pediatric transplants, whether voluntary or involuntary, would 
not impact the center's Medicare approval to perform adult transplants.
    We proposed that a center that performs 50 percent or more of its 
transplants on pediatric patients must be approved to perform pediatric 
transplants in order to be approved to perform adult transplants. For 
these centers, we proposed that loss of Medicare approval to perform 
pediatric transplants, whether voluntary or involuntary, would result 
in a loss of the center's approval to perform adult transplants. We 
proposed that loss of Medicare approval to perform adult transplants 
would not impact the center's Medicare approval to perform pediatric 
transplants.
    For a center that performs 50 percent or more of its transplants on 
pediatric patients, we proposed that there would be no minimum number 
of adult or pediatric transplants required prior to its request for 
Medicare approval. Following are summaries of the comments we received 
and our responses.
    Comment: A commenter noted that it is important for pediatric 
transplant centers to continue to transplant adolescent and young 
adults beyond the pediatric age range (18-25) to maintain continuity of 
care of established patients.
    Response: We agree. In some situations, a young adult for whom an 
organ becomes available has received treatment for end stage organ 
failure from the same pediatric transplant surgeon and pediatric 
transplant physician for many years and understandably wishes to have 
the transplant performed at the pediatric center where these physicians 
practice.
    Under the proposed rule and this final rule, which require separate 
Medicare approvals for performing adult and pediatric transplants, a 
transplant center performing predominately pediatric transplants will 
be able to transplant adolescents and young adults age 18 and older. We 
recognize that pediatric

[[Page 15213]]

programs may need to continue transplanting young adults beyond the 
pediatric age range in order to maintain continuity of care for 
established patients. The health care needs of these patients are best 
addressed in a pediatric setting until appropriate transition to adult 
care can occur. Pediatric centers are required to become certified as 
both a pediatric and adult transplant center if they intend to provide 
transplantation services to both populations.
    Comment: A few commenters agreed that pediatric centers should meet 
the transplant center conditions of participation, but they did not 
agree that adult and pediatric centers should be approved separately. 
The commenters noted that the low volume of adult transplants performed 
at pediatric centers does not justify the cost and labor for the 
centers to seek separate approval to perform adult transplants. 
Likewise commenters said it would be burdensome to require an adult 
center to seek separate Medicare approval just to perform a few 
pediatric transplants.
    Response: We understand the commenters' concerns. In our view, a 
center that performs 50 percent or more of its transplants on adult 
patients in a 12-month period is considered to be an adult transplant 
center whereas a center that performs 50 percent or more of its 
transplants on pediatric patients in a 12-month period is considered to 
be a pediatric transplant center. There are distinct differences 
between adult centers performing occasional pediatric transplant and 
pediatric centers performing occasional adult transplants in terms of 
patient selection criteria, patient management, and the number of 
transplants performed. Because of these differences, we believe that 
approving adult and pediatric centers as one unified program is 
problematic. For example, it would be difficult, if not impossible, for 
pediatric centers to meet clinical experience requirements that are 
appropriate for adult transplant centers, which could impair access to 
pediatric transplants.
    However, we will permit a transplant center to submit its request 
for approval as a pediatric transplant center and its request for 
approval as an adult transplant center using the same application, 
which should minimize the paperwork burden. We made no changes based on 
this comment.
    Comment: Some commenters stated that in most pediatric centers, the 
core transplant team performs both adult and pediatric transplants. The 
commenters said that to be consistent with OPTN requirements for 
pediatric centers, we should allow the sharing of personnel in 
transplant hospitals that have both adult and pediatric transplant 
programs. Some commenters recommended treating adult and pediatric 
transplant centers as one unified program or adopting the statutorily-
based approval criteria as used in pediatric heart transplant centers.
    Response: We recognize that many centers that perform pediatric 
transplants are operated by, or affiliated with, a Medicare-approved 
adult transplant center. In some transplant centers, the core 
transplant team performs both adult and pediatric transplants. We have 
no objection to such arrangements, provided that a transplant center 
has committed sufficient resources to both its pediatric and its adult 
transplant programs. There is nothing in the final rule that precludes 
a pediatric center and an adult center from operating as one unified 
program. Nevertheless, we would emphasize that an adult transplant 
center may not attempt to meet the clinical experience requirement by 
combining the number of adult transplants it has performed with 
pediatric transplants that were performed at its pediatric center. The 
outcomes of pediatric and adult transplant centers are reviewed 
separately.
    Comment: A commenter recommended adopting the OPTN pediatric 
transplant standards.
    Response: OPTN pediatric transplant policies relate primarily to 
pediatric organ allocation, and transplant surgeon and physician 
training and experience, and they differ significantly from our 
proposed CoPs for pediatric centers. We did not make any changes based 
on the comment.
    We received no comments on our proposal to allow a heart transplant 
center to provide transplantation services to pediatric heart patients 
to be approved to perform pediatric heart transplants by meeting the 
OBRA 1987 criteria in section 4009(b) (Pub. L. 100-203). Therefore, the 
proposal was finalized without change except for the addition of the 
OBRA 1987 citation.

Condition of Participation: Data Submission, Clinical Experience, and 
Outcome Requirements for Initial Approval of Transplant Centers 
(Proposed Sec.  482.80)

    We proposed that transplant centers must meet all of the data 
submission and outcome requirements in order to be granted our initial 
approval. If a center failed to meet any of the requirements, no waiver 
would be granted. However, we did propose certain exceptions, which are 
discussed below.

Proposed Data Submission Requirements

    We proposed at Sec.  482.80(a) that no later than 90 days after the 
due date established by the OPTN, a transplant center must submit to 
the OPTN at least 95 percent of required data submissions on all 
transplants (deceased and living donor) that the center has performed 
at the center.
    We proposed that required data submissions would include, but not 
be limited to, the submission of the appropriate organ-specific OPTN 
forms for transplant candidate registration, transplant recipient 
registration, and transplant recipient follow up.
    We proposed using the same data submission requirements for both 
initial approval and re-approval.

Proposed Outcome Requirements

    We proposed using the same outcome requirements for both initial 
approval and re-approval.
    We proposed using the SRTR's center-specific reports as the 
foundation of our outcome evaluation system. We proposed reviewing 
outcomes for all transplants performed at a center, including outcomes 
for living donor transplants, if applicable. With the exception of lung 
transplants, we will review adult and pediatric outcomes separately 
when a center requests Medicare approval to perform both adult and 
pediatric transplants. The OPTN policies for the cutoff for pediatric 
lung allocation and outcome assessment is under 12 years old, and the 
number of pediatric (under 12 years old) lung transplants is very 
small. Therefore, the outcomes of pediatric lung transplants and adult 
lung transplants are reviewed together. We proposed that we would 
compare each transplant center's observed number of patient deaths and 
graft failures 1-year post-transplant to the center's expected number 
of patient deaths and graft failures 1-year post-transplant (or under 
certain circumstances, 1-month post-transplant patient and graft 
survival in lieu of 1-year post-transplant patient and graft survival.)
    We proposed that under most circumstances, an adult transplant 
center requesting Medicare approval would need to have 1-year patient 
and 1-year graft survival follow-up data on at least 9 transplants of 
the appropriate organ type during the 2.5 year period reported in the 
most recent SRTR center-specific report.
    We proposed that we would compare each transplant center's observed

[[Page 15214]]

number of patient deaths and graft failures 1-year post-transplant to 
the center's expected number of patient deaths and graft failures 1-
year post-transplant using the data contained in the most recent SRTR 
center-specific report, as long as the center had 1-year post-
transplant follow up on at least 9 transplants of the appropriate organ 
type. We also proposed that if a center's observed patient survival or 
graft survival rate was lower than the expected patient or graft 
survival rate and the center crossed over all 3 of the non-compliance 
thresholds for all 3 tests (p-value less than 0.05, observed--expected 
greater than 3, and observed/expected greater than 1.5) for either 
graft or patient survival, we would not consider the center to be in 
compliance with the outcome requirements.
    We proposed that a heart-lung transplant center, an intestine 
transplant center, and a pancreas transplant center, as defined in the 
final rule, would not be required to comply with the outcome 
requirements for re-approval.
    We proposed that a center requesting Medicare re-approval to 
perform pediatric transplants would not be required to perform a 
minimum number of pediatric transplants prior to its request for 
Medicare re-approval.
    Comment: Some commenters supported the proposed data submission 
requirements. The commenters were pleased that the provisions would not 
require additional data beyond the OPTN requirements. The commenters 
asked us to emphasize that follow-up data are essential for evaluating 
and reporting of outcomes and the refinement of organ allocation 
policies.
    Response: We appreciate the commenters' understanding of the 
importance of data submission in the accurate assessment of transplant 
center performance. We did not propose and are not requiring under this 
final rule that transplant centers report additional data beyond what 
they already report to the OPTN. The OPTN's comprehensive data 
reporting policies provide sufficient data for us to determine whether 
transplant centers meet the outcome measures in this final rule.
    Comment: A commenter stated that we should coordinate our data 
submission requirements with the OPTN's, so that centers do not have to 
submit data both to us and to the OPTN.
    Response: Under this final rule, we require transplant centers to 
continue to submit the required data to the OPTN UNetSM 
system (or any successor system under the OPTN Contract) in accordance 
with the specified time frame. UNetSM is a secure system for 
transplant hospitals to communicate transplant information and data to 
UNOS. We are not requiring transplant centers to submit data to us 
separately on a routine basis.
    Comment: A commenter stated that compliance with the data 
submission requirements should not be used as the basis for denial of 
Medicare approval and re-approval. The commenter said that there is no 
evidence linking failure to submit OPTN-required data with poor 
outcomes.
    Response: Given that the national and center-specific outcome 
measures calculated by the OPTN are based largely on data submitted by 
the transplant centers, it is imperative for centers to report data to 
the OPTN completely, accurately, and in a timely manner. We cannot 
provide meaningful oversight of center activities without complete and 
timely data submission. To ensure that the data used by the SRTR for 
analysis and compilation of the national and center-specific reports 
are comprehensive and accurate, we must have data submission 
requirements. We made no changes based on this comment.
    Comment: Some commenters expressed concern that the expanding scope 
and complexity of OPTN data submission have significant personnel and 
financial implications for transplant centers. The commenters urged us 
to confer with the OPTN to limit the Federal data submission 
requirements to data needed only to calculate 1-year post-transplant 
outcomes.
    Response: We understand the administrative workload required to 
achieve compliance with OPTN data submission policies. In 2006, the 
OPTN engaged in an extensive effort to review all data elements 
currently submitted by transplant centers to determine whether the 
number of elements could be reduced to lessen the burden on centers. 
Based on collaboration with the American Society of Transplant Surgeons 
and the American Society of Transplantation and input from the public, 
the OPTN succeeded in reducing the data entry burden on its transplant 
hospital members. For example, 268 data fields will no longer be 
required for validation of UNetSM forms, such as the 
transplant candidate registration form and the transplant recipient 
registration and follow up forms. Additionally, the requirement to 
follow transplant recipients for 2 years after graft failure has been 
eliminated. With significant reduction in data submission elements such 
as these, the OPTN anticipates that data quality will improve 
significantly. We continue to support the OPTN's commitment to review 
its data collection process annually for opportunities to reduce 
burden.
    However, we believe that the data submitted by transplant centers 
cannot be limited only to those data needed to calculate 1-year post-
transplant outcomes. The more extensive data submitted by transplant 
centers form the backbone for the research and analyses produced by the 
SRTR, and the data are necessary for the OPTN, CMS, and transplant 
centers to develop sound policies. No changes were made based on this 
comment.
    Comment: Some commenters requested that we quantify whether ``95 
percent compliance'' means 95 percent of forms, patients, or data 
fields. A commenter suggested a data compliance threshold of less than 
95 percent.
    Response: By 95 percent compliance, we mean that 95 percent of the 
OPTN-required forms on all transplants (deceased and living donors) 
must be completed and submitted within 90 days following the OPTN-
required time frame. This requirement provides transplant centers with 
an additional 90 days beyond the OPTN due date to comply. In our view, 
lowering the threshold to less than 95 percent is unacceptable and 
inconsistent with OPTN requirements. Therefore, we did not make any 
changes based on this comment.
    Comment: A commenter recommended that if a center produces 
independent evidence that it has submitted the required data timely or 
if a center's failure to produce the required data is attributable to 
unique circumstances that are unlikely to recur, we should consider the 
center to be compliant with data submission requirements. One commenter 
stated that the imposition of the ``no later than 90 days after the 
OPTN due date'' deadline is unnecessarily harsh and recommended that, 
as long as a transplant center submits 95 percent of the required 1-
year data in time to be included in the SRTR report, we should consider 
the transplant center to be compliant. Another commenter expressed 
concern that tying Medicare approval to compliance with the 95 percent 
data submission requirement would result in centers submitting poor 
quality data. The commenter suggested that in an effort to comply, 
centers may resort to marking data elements as ``unknown'' or ``lost to 
follow up'' more often than is currently done.
    Response: Data submission policies that differ from those of the 
OPTN are likely to confuse transplant centers and result in decreased 
compliance with OPTN policies. When reviewing a center's compliance 
with the data

[[Page 15215]]

submission requirements, we will take into consideration whether 
circumstances beyond the control of the center prevented it from fully 
complying with the data submission policies. Nevertheless, any willful 
falsification of data by a transplant center will be considered a 
violation of the data submission requirements in this final rule, as 
well as that of 42 CFR 121.11(b)(2).
    Comment: Some commenters asked that we exempt kidney transplant 
centers from data submission and outcome requirements because kidney 
transplants are covered under the Act.
    Response: The Act provides the authority for Medicare to pay for 
kidney transplantation. However, it does not preclude us from 
establishing requirements that kidney transplant centers must meet to 
participate in the Medicare program. In fact, the statute specifies 
that payment will be made for kidney transplantation to providers of 
services that ``meet such requirements as the Secretary shall by 
regulation prescribe * * *'' (See section 1881(b)(1)(A) of the Act.)
    Further, as noted in the preamble to the proposed rule, we are 
committed to bringing both the kidney and extra-renal transplant 
requirements up to date. For consistency across all types of transplant 
centers, we are requiring Medicare-approved transplant centers, 
including kidney transplant centers, to submit transplant data per OPTN 
data submission requirements. No changes were made based on this 
comment.
    Comment: Another commenter recommended that we amend the regulation 
text to require the submission of 95 percent of a program's data within 
3 months of the due date and 100 percent of the program's data within 6 
months of the due date.
    Response: We expect transplant centers to comply with the OPTN 
policy to submit 100 percent of the required data within 6 months of 
the due date. However, we are not including the requirement in this 
final rule because a requirement for 100 percent compliance would be 
problematic within our framework for Medicare oversight and 
enforcement. For example, if the OPTN notified us that a transplant 
center had submitted only 99.9 percent of its data within the required 
time frame, under such a requirement we would consider the transplant 
center to be out of compliance, which could subject the transplant 
center to review and adverse action.

Clinical Experience

    We requested comments on: (1) Whether requiring a minimum number of 
9 transplants during a 2.5 year period would be acceptable for the 
application of the SRTR methodology; and (2) whether our proposal to 
focus more heavily on a center's outcomes by eliminating volume as a 
separate standard and integrating volume into our outcome measures 
would provide us with the necessary data. In addition, three peer 
reviewers provided comments on the following specific issues related to 
volume: (1) Other alternative minimum volume criteria that would ensure 
that the 3 test criteria can be applied properly; and (2) 
appropriateness of volume standards for pediatric transplants.
    Comment: Only one commenter said that eliminating volume as a 
separate standard would be a positive change. Overall, commenters said 
that the proposed methodology-based volume of 9 transplants in a 2.5 
year cohort would be unacceptable as a basis for approval or re-
approval of transplant centers. Commenters noted that a threshold of 9 
transplants in 2.5 years would be much lower than the current Medicare 
annual thresholds (10 for lungs and intestines, 12 for hearts and 
livers, and 15 for kidneys). One commenter said that the proposed 
volume should not be used to assess a center's performance because it 
neither serves the best interests of patients nor supports our stated 
goal to raise transplant standards. Another commenter said that no 
center performing only 9 transplants in 2.5 years can be considered a 
legitimate transplant program. Still another commenter said that the 
proposed volume is so low that it essentially would eliminate a 
requirement for volume. One commenter suggested that with the exception 
of isolated geographic locations, we should require 15 transplants as 
the absolute minimum annual volume, with a higher annual requirement 
for kidney and liver transplants, such as 30 transplants of each organ 
per year.
    Two peer reviewers voiced concern that the methodology-based volume 
requirement we proposed may allow Medicare-approved centers to become 
inactive but retain their Medicare approval.
    Response: We proposed requiring only 9 transplants in the 2.5 year 
cohort used for SRTR center-specific reports because 9 transplants is 
the minimum number necessary for the SRTR-based methodology to flag a 
poorly-performing center. In the preamble to the proposed rule, we 
acknowledged the possibility that a center could perform 9 transplants 
in a short period of time and remain inactive for a much longer period, 
while still retaining its Medicare approval. Nevertheless, we posited 
that the OPTN's oversight of transplant center ``functional 
inactivity'' would guard against this circumstance.
    Additionally, in our move toward an outcome-focused system that 
reflects the clinical experience, resources, and commitment of a 
transplant program, we have revised the preamble and the regulations 
text by removing references to ``volume requirements'' and instead 
refer to ``clinical experience requirements.'' We believe this change 
reflects our intent to approve transplant centers using an outcome-
based methodology under which the number of transplants performed is 
one of several factors we consider.
    However, the comments we received from the public and from peer 
reviewers, as well as recent findings of prolonged inactivity or sub-
optimal clinical experience at some transplant centers, have caused us 
to re-evaluate our position. In analyzing this issue, we considered 
several factors, including the possible impact of clinical experience 
on quality of outcomes and the ability of a patient on a transplant 
center's waiting list to obtain a transplant.
    Few research studies have been conducted on the link between volume 
and quality of outcomes in transplantation. A 1994 study found a 
significantly higher 1-year post-transplant mortality rate among 
patients transplanted at centers that performed fewer than 9 heart 
transplants per year when compared to patients transplanted at centers 
that performed 9 or more heart transplants per year. (Hosenpud JD, 
Breen TJ, et al. The effect of transplant center volume on cardiac 
transplant outcomes: a report of the United Network for Organ Sharing 
Registry. Journal of the American Medical Association, 1994; 271: 1844-
1849.)
    A 1999 study using 1994 through 1997 data showed a similar 
correlation between liver transplant volumes and outcomes. 
Specifically, patients transplanted at liver centers that performed 20 
or fewer transplants per year had significantly higher 1-year post-
transplant mortality than patients transplanted at liver centers that 
performed more than 20 transplants per year. (Edwards, EB, Roberts JP, 
et al. The effect of the volume of procedures at transplantation 
centers on mortality after liver transplantation. New England Journal 
of Medicine, 1999; 341: 2049-2053.)
    However, we believe it would be problematic to base clinical 
experience requirements on research conducted on transplants performed 
when survival rates, particularly liver transplant

[[Page 15216]]

survival rates, were significantly lower than they are today. That is, 
1-year risk-adjusted survival after heart transplantation was 83.4 
percent in 1994 but had increased to 87.96 percent during the most 
recent SRTR cohort for which data are available, July 1, 2002 through 
December 31, 2004. Further, 1-year risk-adjusted survival after liver 
transplantation was 76.3 percent in 1994 but had increased to 86.59 
percent during the most recent time period for which data are 
available, January 1, 2003 through June 30, 2005. In contrast, 1-year 
survival from 1994 through 1997 at the high-volume liver centers in the 
1999 study was only 80 percent.
    A study published in 2004 looked at data for adult patients who 
received kidney or liver transplants between January 1, 1996 and 
December 31, 2000. (Axelrod DA, Guidinger MK, et al. Association of 
center volume with outcome after liver and kidney transplantation. 
American Journal of Transplantation, 2004; 4: 920-927.) The study found 
a significantly lower rate of 1-year post-transplant kidney graft 
failure at high volume centers when compared to medium, low, or very 
low volume centers. The study also found a significantly different rate 
of 1-year post-transplant patient mortality at high, medium, and low 
volume liver centers; low volume centers were associated with a 
significantly higher risk of death. Despite these findings, the study's 
authors concluded that there is no clear minimal threshold volume.
    Additionally, the study's authors identified several potential 
implications from the results of the study, noting that efforts are 
underway in other (non-transplant) surgical fields to concentrate 
procedures at high volume centers when there is a relationship between 
volumes and outcomes. The study suggested that even with a clear 
association between volume and outcomes in transplantation, ``The 
adoption of such a policy for liver and kidney transplantation would 
not be straightforward even if it were desirable, particularly in the 
case of deceased donor transplantation [because] the benefit of high-
volume center performance must be carefully weighed against the 
increased risk of graft loss associated with the increased cold 
ischemia time [that] would likely accompany increased regionalization 
of transplant services.'' The authors also pointed out that ``the 
frequent follow-up visits necessary after transplantation might prove 
to be an added hardship if patients were forced to travel great 
distances. Because patients may be more compliant with follow-up visits 
if appointments are convenient, compliance may also be an important 
determinant of outcome.''
    Because research on the effect of volume on outcomes in 
transplantation provides little guidance in establishing the 
appropriate amount of clinical experience for Medicare approval, we 
looked at the waiting lists at heart, liver, and kidney centers that 
have volumes below current Medicare requirements, (12 transplants per 
year for heart centers and liver centers and 15 transplants per year 
for kidney centers), and compared them to the waiting lists at higher 
volume heart, liver, and kidney centers. We found indications that 
there may be a link between clinical experience and how well patients 
fare while they are still on the waiting list.
    For example, in 2005, there were approximately 117 adult heart 
transplant centers in the United States. According to the SRTR, 69 
centers performed 12 or more transplants, and 48 performed fewer than 
12 transplants. Out of the 69 centers that performed 12 or more 
transplants, 1 had a higher than expected mortality on the waiting 
list. Of the 48 centers that performed fewer than 12 transplants, 5 had 
higher than expected mortality on the waiting list.
    Nationwide in 2005, there were approximately 106 adult liver 
transplant centers in the United States. There were 6,122 patients on 
the liver transplant waiting list. Slightly more than 28 percent 
(1,745) of these patients died without receiving a transplant. Of the 
96 adult liver transplant centers that performed 12 or more transplants 
in 2005, only one center had more deaths on the waiting list than the 
number of transplants it performed. However, among the 10 liver centers 
that performed fewer than 12 transplants in 2005, 5 centers had more 
deaths on the waiting list than the number of transplants it performed. 
Of those 5 centers, 2 centers had approximately 3 times the number of 
deaths on the waiting list as the number of transplants they performed. 
For example, one liver center performed 7 transplants in 2005 and had 
20 waiting list deaths during the same time period.
    We also considered whether center clinical experience affects the 
ability of waiting list patients to obtain a transplant by reviewing 
transplant rates for kidney centers in 2004/2005. The SRTR calculates 
whether a center's transplant rate for deceased donor transplants is 
statistically higher, statistically lower, or not significantly 
different from other transplant centers. Although we found no 
definitive link between a kidney center's clinical experience and the 
transplant rate calculated by the SRTR, we note that the transplant 
rate of a small center generally would not be considered statistically 
lower than expected even if the center performed no transplants during 
a given year due to the small number of patients on its waiting list. 
However, in reviewing the data, we found that 7 out of the 
approximately 231 adult kidney transplant centers in the United States 
in 2004 and 2005 performed no transplants at all during those 2 years. 
The number of patients on the waiting lists of the 7 centers numbered 
between 9 and 47. Although the number of patients affected was small, 
we are concerned that patients continued to be listed on the waiting 
lists of centers that performed no transplants in 2 years. We note 
that, at present, all 7 centers are listed as inactive on the SRTR's 
Web site.
    In summary, public commenters and some peer reviewers recommended a 
volume standard higher than the proposed 9 transplants in 2.5 years. 
None of the peer reviewers recommended a specific volume. Studies of 
the effect of volume on outcomes in transplantation suggest that higher 
volume centers have better outcomes, although there is no evidence that 
indicates what the minimum threshold should be. Also, our review of 
waiting list data raises the concern that waiting list patients at 
small centers may not fare as well as waiting list patients at larger 
centers, both in terms of waiting list mortality and the ability to 
obtain a transplant.
    Further, as discussed earlier in this preamble, in the fall of 
2005, we found that some centers, although not considered 
``functionally inactive'' by the OPTN, performed few transplants and 
refused a high percentage of organs that were offered to them for 
transplantation into their waiting list patients, leading to longer 
than average waiting times and, possibly, an increased number of deaths 
among their waiting list patients. These factors must be weighed 
against the necessity to maintain Medicare beneficiaries' access to 
transplantation. Also, we must keep in mind the concerns raised by the 
2004 study of volume and outcomes in kidney and liver transplantation 
that centralizing transplants in too few centers could be detrimental 
to transplant outcomes.
    Based on these considerations, we believe transplant centers should 
be required to perform more than 9 transplants in 2.5 years to become 
Medicare approved and, once approved, retain their Medicare approval. 
Without strong statistical evidence supporting a particular threshold 
for any of the organ types, we believe the most appropriate

[[Page 15217]]

solution is to establish a clinical experience requirement that is 
close to the current volume requirements in our NCDs for heart, 
intestine, liver, and lung transplant centers and in our CfCs for 
kidney transplant centers. We believe establishing a clinical 
experience requirement of 10 transplants per year for all organ types 
for both approval and re-approval of transplant centers is both 
sensible and the least disruptive for transplant centers that have 
current Medicare approval and for the beneficiaries on the waiting 
lists of these centers.
    We are revising Sec.  482.80(b) to state that to be Medicare 
approved under this final rule, adult transplant centers (with the 
exception of heart-lung centers, kidney transplant centers, and 
pancreas centers) generally must perform 10 transplants over a 12 month 
period. We are revising Sec.  482.82(b) to state that to be re-approved 
under this final rule, a transplant center must perform an average of 
10 transplants per year during the re-approval period. There are no 
minimum clinical experience requirements for initial approval or re-
approval for heart-lung, pancreas, or pediatric centers. (Kidney 
transplant centers generally must perform 3 transplants over a 12-month 
period for initial approval and 10 transplants annually for re-
approval.) (See Sec. Sec.  482.80(d)(4) and 482.82(d)(4).) Note that an 
adult transplant center may not attempt to meet the clinical experience 
requirement by combining adult transplants with pediatric transplants 
performed at an affiliated pediatric center.
    As stated previously, the main intent of the clinical experience 
requirement for re-approval is to ensure that Medicare-approved centers 
stay active. We recognize that a center's transplant numbers may 
fluctuate at times. Nonetheless, we believe that a transplant center 
must perform an average of 10 or more transplants per year to 
demonstrate commitment to its transplant program and gain adequate 
clinical experience.
    To determine a center's compliance with the clinical experience 
requirement, we will review the data contained in the most recent OPTN 
Data Report and SRTR center-specific reports. (See Sec.  488.61(a)(2) 
and Sec.  488.61(c)(1)(ii).)
    Comment: Some commenters said that all kidney transplant centers 
should be exempt from initial approval requirements (such as the 
requirement to perform 9 transplants) because a lengthy initial 
approval process would delay access to the new kidney center's 
transplantation services for Medicare beneficiaries. That is, until a 
new kidney transplant center receives Medicare approval, Medicare will 
not pay for beneficiaries to receive transplants at the facility.
    Response: We share the commenters' concern that a lengthy approval 
process for kidney centers, particularly a requirement to perform 10 
transplants prior to approval, may prevent kidney transplant centers 
from opening in areas of the country where access to kidney transplant 
services is already limited.\1\ Meeting a clinical experience 
requirement of 10 transplants would be particularly difficult for new 
kidney transplant centers, because Medicare is either primary payer or 
secondary payer for 69 percent of kidney transplants performed in the 
United States, while the other 31 percent of kidney transplants are 
paid for by private insurance, Medicaid, and the Department of Veterans 
Affairs (unlike extra-renal transplants for which Medicare pays between 
approximately 20 percent and 40 percent, depending upon organ type). 
Thus, a new kidney transplant center would have considerable difficulty 
finding 10 non-Medicare patients to transplant.
---------------------------------------------------------------------------

    \1\ Although nearly half of all transplant centers in the United 
States are kidney transplant centers, there are barriers to access 
to kidney transplantation services in some areas of the country 
where there are large dialysis populations but few kidney transplant 
centers, and in some largely rural States that have no in-State 
kidney transplant centers and few centers in neighboring States.
---------------------------------------------------------------------------

    Under the current ESRD CfCs for kidney transplant centers, a new 
center may be approved without performing any transplants if it has a 
written plan detailing how it will achieve conditional status (7-14 
transplants) within 2 years and unconditional status (15 or more 
transplants) within 4 years. Currently, there are no outcome 
requirements for kidney transplant centers. However, this final rule 
contains outcome requirements for initial approval of kidney transplant 
centers, and in order for us to assess a new kidney transplant center's 
performance, the center must perform some transplants. Taking this 
information into consideration, we have determined that requiring new 
kidney transplant programs to complete 10 transplants before applying 
for approval could prevent new centers from entering the Medicare 
program.
    We believe that completing 3 consecutive, successful transplants, 
as determined by 1-year post-transplant graft and patient survival 
outcomes, is necessary for a new kidney center to demonstrate 
sufficient experience in transplantation and enhances the new 
transplant center's ability to recruit transplant candidates from the 
limited pool of the non Medicare-eligible kidney transplant candidate 
population.
    We are sensitive to the difficulty a new kidney transplant center 
will have in finding non-Medicare patients to transplant. We are 
committed to maintaining and improving access to kidney transplantation 
services for Medicare beneficiaries, but we also believe it is 
essential to assess a kidney transplant center's performance prior to 
approving it for the Medicare program. Therefore, this final rule 
establishes a clinical experience requirement of 3 transplants for 
initial Medicare approval for kidney transplant centers that had not 
been approved by Medicare under Sec.  405.2122 as of this rule's 
effective date at Sec.  482.80(d)(5). We believe this requirement will 
allow new kidney transplant centers to obtain Medicare approval 
expeditiously, while ensuring that some data are available to 
demonstrate whether the center's outcomes are acceptable.
    Like extra-renal transplant centers, kidney transplant centers will 
be approved for 3 years and will be required to perform an average of 
10 transplants per year for re-approval. However, because a kidney 
center will be required to perform only 3 transplants before obtaining 
initial approval, we will scrutinize the center's clinical experiences 
and outcomes closely, particularly in the year following its initial 
approval. CMS will monitor the clinical experience and outcomes 
statistics of the center in the year following its initial approval. We 
are requesting center-specific data already collected through the OPTN, 
and expect to review the data at least quarterly. If the center's 
clinical experience and outcomes highlight a need for additional 
investigation, CMS will follow up through its survey and certification 
process.
    We note that in the past, new transplant centers interested in 
applying for Medicare approval have offered to perform transplants for 
Medicare beneficiaries free of charge so that the center could meet the 
clinical experience requirement for initial Medicare approval quickly. 
This practice has serious implications for a Medicare beneficiary who 
accepts a transplant center's offer of a free transplant. Medicare pays 
for prescription drugs used in immunosuppressive therapy under Medicare 
Part B only if the transplant was performed in a Medicare approved 
facility. Although an individual may be eligible for payment for his or 
her immunosuppressive drugs under

[[Page 15218]]

Medicare Part D, the beneficiary may pay several thousand dollars more 
out of pocket every year.
    Therefore, we have added a requirement under the CoP for Patients' 
and Living Donor Rights at Sec.  482.102(a)(8) and (b)(9) that a 
transplant center must inform Medicare beneficiaries who are 
prospective transplant recipients and their prospective living donors 
that receiving a transplant that is not provided in a Medicare-approved 
transplant center could affect the transplant recipient's ability to 
have his or her immunosuppressive drugs paid under Medicare Part B. See 
further discussion of this requirement in this preamble under 
``Patients and Living Donor Rights'' and ``Centers With Current 
Medicare Approval.''
    Comment: A commenter stated that OPTN policies do not specify that 
transplant centers must perform a minimum number of transplants per 
year and said that our requirements and those of the OPTN should be 
consistent. A commenter also asked us to clarify in more detail what 
the OPTN means when it terms a transplant center ``functionally 
inactive,'' as well as how this status may impact a center's 
eligibility to receive organs.
    Response: As discussed in the proposed rule, although the OPTN does 
not require a transplant center to perform a minimum number of 
transplants, programs (centers) are reviewed and may be classified as 
``functionally inactive'' if they have not performed a single 
transplant within a specified period of time. The specific time frame 
that the OPTN Membership and Professional Standards Committee (MPSC) 
uses to determine ``functional inactivity'' is 3 months for kidney, 
liver, and heart programs, 6 months for pancreas and lung programs, and 
1 year for stand-alone pediatric programs. Under OPTN Bylaws, Appendix 
B(II), an OPTN member transplant hospital that fails to remain 
functionally active with respect to any designated transplant program 
may be encouraged to voluntarily deactivate its transplant program 
until such time as the circumstances affecting the status of the 
program have been resolved (up to 12 months) or relinquish designated 
transplant status for the program. If the member fails to take either 
action voluntarily, the MPSC may recommend that the Board of Directors 
notify the Secretary of this inactivity (if the transplant program is 
Medicare approved or located within a Federal hospital) and take 
appropriate action in accordance with the OPTN bylaws.
    The OPTN's determination that a transplant program is 
``functionally inactive'' does not, by itself, prohibit a center from 
receiving organs. However, hospitals with transplant centers usually 
follow the recommendation of the MPSC by voluntarily inactivating the 
transplant center in question.
    Although we want to ensure that transplant centers remain active, 
we do not want a transplant center that is experiencing problems to 
continue to perform transplants just to avoid losing its Medicare 
approval. Therefore, we have added a provision to this final rule that 
a transplant center may inactivate its program for a period not to 
exceed 12 months during the 3-year approval cycle without losing its 
Medicare approval (see Sec.  488.61(e)), but the center must notify us 
immediately of significant changes in the number of transplants 
performed, as required at Sec.  482.74(a)(4). The transplant center 
also must notify the patients on its waiting list and, as requested by 
the Secretary, assist patients in transferring to the waiting list at 
another transplant center, without loss of time accrued on the waiting 
list. (See Sec.  482.102(c)(3).) We will confer with HRSA and the OPTN 
on a case-by-case basis to determine whether to instruct an inactive 
center to notify its waiting list patients and assist them in 
transferring to another transplant center's waiting list.
    We proposed that a center that was requesting initial Medicare 
approval to perform pediatric transplants would not be required to 
perform a minimum number of pediatric transplants prior to its request 
for Medicare approval.
    Comment: Most commenters agreed that volume requirements are not 
relevant for pediatric centers and they strongly supported having no 
volume requirements for centers performing pediatric transplants. Two 
peer reviewers said that a volume requirement would be inappropriate 
for pediatric centers. One peer reviewer agreed that volume standards 
are not appropriate for pediatric transplant programs, but also 
expressed concerns about the ability of pediatric centers to maintain 
their expertise because many centers perform so few pediatric 
transplants. Another peer reviewer stated that since setting a volume 
requirement for small pediatric centers is challenging, Medicare 
approval for pediatric centers that are affiliated with Medicare-
approved adult transplant programs is recommended. Like the other peer 
reviewer, this peer reviewer also had concerns about small, stand-alone 
pediatric transplant programs' ability to maintain resources and 
expertise in transplantation.
    However, two commenters stated that a minimum volume requirement is 
necessary to ascertain the commitment and investment a hospital has 
made in its pediatric transplant center. One commenter recommended ten 
pediatric transplants a year for liver and kidney programs and a lower 
volume for heart programs. The commenter suggested counting open and 
closed congenital heart surgeries toward the volume requirement for 
pediatric heart transplants. One commenter expressed a strong belief 
that having no volume requirement for pediatric transplant centers 
would allow small programs with limited resources to perform 
transplants, with potential poor outcomes.
    Response: Given the nature of the pediatric transplants performed 
and the low numbers of pediatric transplants in general, it would be 
impossible for most pediatric transplant centers to obtain Medicare 
approval if we required them to meet clinical experience requirements, 
limiting access for pediatric Medicare beneficiaries who need 
transplants. As stated earlier, we will monitor pediatric centers' 
outcomes to ensure they provide high quality transplantation services 
to Medicare pediatric patients. We made no changes based on this 
comment.
    Comment: Some commenters stated that in most pediatric centers, the 
core transplant team performs both adult and pediatric transplants. The 
commenters said that to be consistent with OPTN requirements for 
pediatric centers, we should allow the sharing of personnel in 
transplant hospitals that have both adult and pediatric transplant 
programs. Some commenters recommended treating adult and pediatric 
transplant centers as one unified program or adopting the pediatric 
heart transplant center statutory approval criteria.
    Response: We recognize that many centers that perform pediatric 
transplants are operated by or affiliated with a Medicare-approved 
adult transplant center. In some transplant centers, the core 
transplant team performs both adult and pediatric transplants. We have 
no objection to such arrangements, provided that a transplant center 
has committed sufficient resources to both its pediatric and its adult 
transplant programs. There is nothing in the final rule that precludes 
a pediatric center and an adult center from operating as one unified 
program. Nonetheless, approval of the pediatric center is not 
automatic. The pediatric center and adult center must apply for 
separate approval.
    We invited comments from the public on the proposed outcome 
requirements.

[[Page 15219]]

In addition, we conducted independent peer reviews of the following 
specific issues related to the outcome requirements:
    (1) Appropriateness and usefulness of using 1-year post-transplant 
graft and patient survival rates to assess transplant center 
performance;
    (2) Alternative outcome measures;
    (3) Appropriateness of using 1-month post-transplant data for 
initial approval of new centers;
    (4) Outcome measures for heart-lung, intestine and pancreas 
transplant centers;
    (5) Use of the Cox model to explain the risk-adjusted expected 1-
year post-transplant graft and patient survival rates;
    (6) Appropriateness of using the 3 proposed thresholds to determine 
center performance; and
    (7) Use of the proposed p-value to assess centers with >= 9 
transplants during a 2.5-year period. None of the peer reviewers 
suggested alternative outcome measures. All reviewers agreed that the 
Cox model is the most widely used, flexible, and reliable tool to 
measure transplant outcomes because it allows adjustments, additions, 
or deletions of co-variables to reflect clinical changes in 
transplantation over time.
    Following are summaries of the comments we received and our 
responses.

Use of 1-Year Post-Transplant Graft and Patient Survival Rates as 
Outcome Measure Standards

    In our discussion of outcome measures in the preamble to the 
proposed rule, we said that we would compare each transplant center's 
observed number of patient deaths and graft failures 1-year post-
transplant to the center's expected number of patient deaths and graft 
failures 1-year post-transplant, using the most recent SRTR center-
specific reports. We also stated that we would not consider a center's 
patient and graft survival rates to be acceptable if a center's 
observed patient survival rate and observed graft survival rate is 
lower than its expected patient survival rate or expected graft 
survival rate.
    Comment: Many commenters agreed that risk-adjusted graft and 
patient survival rates are appropriate measures of transplant center 
performance. Some commenters stated that the proposed comparison of 1-
year observed graft/patient survival rates with 1-year expected graft/
patient survival rates is reasonable and achievable. The commenters 
noted that the proposed risk-adjusted survival data with a 1-year 
follow-up period has more statistical validity than the evaluation of a 
survival curve at a particular time point, such as when the Kaplan 
Meier model is used. The commenters appreciated our effort to strive 
for consistency with OPTN standards and in establishing meaningful 
outcome standards. One commenter believed that outcome measure reviews 
should be based on trends and not just on one single snapshot in the 
SRTR reports.
    All three peer reviewers agreed with the public commenters that it 
is appropriate to use 1-year graft and patient survival rates to assess 
transplant center performance. Three peer reviewers added that a 
survival time frame longer than 1 year, such as 3 years or 5 years, may 
provide a more accurate assessment of center performance and minimize 
statistical deviations for small centers. However, they pointed out 
that the drawback of a longer time frame is that more patients would be 
lost to follow up, and a longer time frame may not be applicable to 
smaller programs.
    Response: Although we agree that a time frame for the outcome 
measures longer than 1-year post-transplant would provide some 
additional information, the drawbacks include increased mortality from 
patients' co-morbidities and more patients lost to follow up. We 
believe that utilizing 1-year survival data for approvals and re-
approvals is sufficient. We have made no changes based on these 
comments.

Alternatives to the OPTN Outcome Thresholds

    We solicited comments on different options to apply the SRTR 
methodology. Following are summaries of the comments we received and 
our responses.
    Comment: A commenter stated that graft and patient survival rates 
alone do not give a complete picture of transplant center performance. 
The commenter encouraged us to continue to identify or develop measures 
to capture the full scope of a transplant center's performance.
    Response: We agree with the commenter that graft and patient 
survival rates alone do not provide a complete picture of transplant 
center performance. To provide a broader view, we will assess each 
center's compliance with the other CoPs, which focus on other measures 
of quality, such as direct patient care. If the OPTN and SRTR develop 
additional measures, we will consider whether those measures should be 
incorporated into our CoPs through the rulemaking process. We made no 
changes based on this comment.
    Comment: A commenter suggested including waiting list mortality, 
the number of organ donors, and the size of the waiting list in the 
outcome measure analysis.
    Response: We considered using waiting list mortality as one of the 
outcome measures, but after careful deliberation, we determined that 
using this criterion would be problematic because transplant centers do 
not provide direct patient care for all of the patients on their 
waiting lists. Some waiting list patients routinely receive their 
primary care from other providers, particularly patients awaiting 
kidney transplants who are likely to receive their care through a 
dialysis facility. In addition, some waiting list patients are listed 
at more than one center. We would have considerable difficulty 
determining which transplant center should be accountable for the death 
of a patient listed on more than one waiting list. Finally, waiting 
list patients may die for reasons unrelated to their end-stage organ 
failure. We believe it would be unfair to hold a transplant center 
responsible for the death of a waiting list patient if the cause of 
death were unrelated to the patient's transplant.
    Although the commenter suggests using the number of organ donors as 
one of the outcome measures in the final rule, we would point out that 
cooperating with organ procurement organizations (OPOs) in the organ 
donation process would be a function of the hospital in which a 
transplant center is located, not of the transplant center itself. 
Furthermore, the hospital CoP at Sec.  482.45 ``Organ, tissue, and eye 
procurement'' lists specific requirements all hospitals must meet 
related to their performance as donor hospitals. We made no changes 
based on this comment
    Comment: A commenter also suggested using the size of a transplant 
center's waiting list as an outcome measure.
    Response: We disagree. There are many different variables affecting 
the size of a transplant center's waiting list, such as geographic 
location, patient selection criteria, cultural factors, and transplant 
resources, among others. Thus, we do not believe the size of a 
transplant center's waiting list is an appropriate outcome measure. We 
did not make any changes based on these comments.

[[Page 15220]]

The 3 Thresholds (p < 0.05, Observed--Expected > 3, and Observed/
Expected > 1.5)

    We requested comments on the three proposed non-compliance 
thresholds for the outcome measures and solicited data and evidence 
that would support alternative thresholds, especially thresholds 
specific to a particular organ type.
    We proposed that a transplant center's performance would not be 
acceptable if its observed patient survival rate and observed graft 
survival rate were lower than its expected patient survival rate and 
expected graft survival rate and if all three of the following 
thresholds were crossed over:
    (1) One-sided p-value is less than 0.05;
    (2) Number of observed events (patient deaths or graft failures) 
minus the number of expected events is greater than 3; and
    (3) Number of observed events divided by the number of expected 
events is greater than 1.5.
    Comment: Although some commenters expressed support for the three 
proposed thresholds, a few commenters stated that these thresholds 
would be too lenient. Other commenters suggested making the thresholds 
more rigorous but only if the outcome measures were used solely as a 
trigger for further investigation. Three peer reviewers supported using 
all 3 proposed non-compliance thresholds (p < 0.05, O--E > 3, and O/E > 
1.5) to determine transplant center performance. However, one peer 
reviewer recommended changing the threshold for O/E > 1.5 to O/E > 1.3 
in order to narrow the variations among centers. One commenter stated 
that the three thresholds for outcome measures are arbitrary since the 
outcome measure methodology may change in the future.
    Response: We disagree that the proposed thresholds are too lenient. 
The OPTN uses the same thresholds currently to flag centers for further 
review, and the SRTR uses the thresholds to report observed and 
expected patient and graft survival.
    Changing the threshold of O/E > 1.5 to O/E > 1.3, as one peer 
reviewer suggested, would be inconsistent with the OPTN O/E threshold 
for flagging centers for further review. If the OPTN changes the 
criteria to narrow the variation in the future or we determine that the 
threshold is insufficiently rigorous for our purposes, we will re-
assess it.
    We will not use these thresholds simply to flag centers for further 
review as suggested by some of the commenters. Although failure to meet 
the outcome requirements does not mean that a transplant center will be 
denied Medicare approval automatically or lose Medicare approval 
automatically, a transplant center's performance on the outcome 
requirements is the single most important factor we will consider in 
making these determinations because these measures are designed to 
reflect the importance of the need for a transplant center to have 
sufficient expertise in all phases of transplantation, such as 
conducting pre-transplant evaluations, performing the surgical 
procedure, and regulating post-transplant immunosuppression and other 
medications to prevent graft failure. Since we will be using outcomes 
data, along with other data and information on transplant center 
performance, to make decisions on initial approvals and re-approvals of 
transplant centers, we believe the thresholds are sufficiently rigorous 
to ensure we can identify transplant centers whose performance is 
unacceptable.
    We do not agree that simply because we or the OPTN may change the 
proposed outcome requirements in the future, they are definitionally 
arbitrary. We are establishing thresholds at a level that is optimal to 
identify transplant centers whose performance is not adequate for 
delivery of transplantation services to Medicare beneficiaries. If we 
determine in the future that any of the three thresholds is too low or 
too high, we will propose changes in the threshold through the 
rulemaking process. We made no changes based on these comments.
    Comment: A few commenters suggested that we should establish the 
criteria for unacceptable performance at crossing over 2 out of the 3 
(instead of all 3) non-compliance thresholds.
    Response: Throughout the final rule, we have been careful to 
conform our requirements to OPTN policies in almost all cases, so that 
our requirements for and our oversight of transplant centers does not 
conflict with the OPTN's. Currently, the OPTN requires that a 
transplant center has crossed over all three thresholds to be flagged 
for further review. We do not believe it would make sense to adopt the 
SRTR methodology and most of the OPTN's outcome measures policies in 
this final rule but establish a different criterion for the thresholds. 
In addition, we are mindful that the existing OPTN thresholds were 
established with the support of the transplant community. If the OPTN 
changes its thresholds in the future, we will determine at that time 
whether we should change the thresholds in our regulations. We made no 
changes based on this comment.
    Comment: A commenter pointed out that the OPTN uses a 2-year 
cohort, but we proposed using a 2.5-year cohort. Commenters said that 
use of different cohort lengths would lead to different results when 
centers are reviewed.
    Response: As of 2005, the SRTR changed the OPTN cohort from 2 years 
to 2.5 years to be consistent with the public SRTR center-specific 
reports.

Appropriateness of Using the Proposed Outcome Requirements, the 3 
Thresholds, and the SRTR Methodology as the Basis To Approve and Re-
Approve Transplant Centers

    Comment: A few commenters supported the basis for the outcome 
measure methodology designed by the SRTR and tested within the 
transplant community. Commenters said they believed that the proposal 
meets the principles of equity and fairness, and the outcome measures 
can be applied equitably to all types of transplant centers, both large 
and small. However, one commenter stated that the OPTN outcome data 
were never designed as a test for Medicare approval and re-approval. 
The commenter recommended that we defer any approval or re-approval 
decisions regarding data submission or outcome requirements to the OPTN 
Board, which makes the final decision about transplant center 
performance.
    Response: We have been using patient survival outcome measures as 
approval criteria for transplant centers since Medicare began paying 
for heart transplants in 1987. Over the years, we have established 
outcome requirements for approval of liver, lung, and intestine 
transplant centers, as well. The sophisticated SRTR methodology 
described in this final rule allows us to improve upon the current 
outcome requirements by incorporating risk adjustment and ensuring 
statistical validity. Clearly, the outcome requirements that we are 
establishing in this final rule also can be utilized as indicators for 
potential problems, which is how we will use them in the approval and 
re-approval processes. Non-compliance with data submission, clinical 
experience, or outcome measure requirements may trigger a review for 
compliance with the CoPs, similar to the OPTN process, which also uses 
transplant outcomes data to flag centers for further review and 
investigation. However, as stated previously, the OPTN does not have 
the oversight authority to approve or re-approve transplant centers for 
Medicare. We

[[Page 15221]]

must conduct the review and investigation of a transplant center that 
does not meet the outcome measures. We have made no changes in this 
final rule based on this comment.
    Comment: A few commenters stated that the SRTR center-specific 
report that we cited for review and approval/re-approval of transplant 
centers is 1 to 3 yrs behind current data and does not reflect a 
transplant center's current outcomes. Therefore, centers that have 
improved recently may be sanctioned unnecessarily. The commenters 
recommended that we review more recent data or data in at least two 
previous SRTR reports to evaluate a transplant center's outcome trends.
    A peer reviewer stated that the outcome measure review should be 
based on outcome trends over a longer period of time and not on a 
single snapshot in the SRTR report. Another reviewer recommended a 
review of graft and patient survival rates in two consecutive SRTR 
reports.
    Response: We agree that some transplant centers' outcome trends may 
be best understood by reviewing two SRTR reports. However, since our 
approach to approving centers is multi-dimensional (data, clinical 
experience, outcomes, and process), and the OPTN review of transplant 
centers is ongoing, we believe that review of one SRTR report is 
sufficient to assess a transplant center's performance. If we 
consistently use the SRTR center-specific reports for outcome review, 
the trend of a center's performance or a clinically significant pattern 
should be reasonably apparent over an extended period of time. The SRTR 
updates its center-specific reports every 6 months. However, since the 
outcome requirements in this rule include 1-year post-transplant data, 
the delay in compiling and reporting the data by the SRTR is 
unavoidable. Thus, the age of the data that we review will vary from 
1.5 to 3 years old.
    Nevertheless, the SRTR reports provide the most cost-effective, 
transparent, and objective measures currently available. Since we will 
use the SRTR center-specific reports consistently to review outcomes, 
the trend of a center's performance or a clinically significant pattern 
should be reasonably apparent over an extended period of time. An on-
site survey will counterbalance the outcomes data if the outcome trend 
is negative but is not reflective of the center's performance. On the 
other hand, the reporting of significant (negative) changes and 
inactivity to CMS will counterbalance the outcomes data if the center's 
performance trend appears to be positive but is, in fact, not 
reflective of the center's performance.
    Comment: Some commenters were concerned that the proposed outcomes 
requirement may not be able to accommodate future changes in the OPTN's 
policies for application of the SRTR methodology or the methodology 
itself. A commenter suggested that we should include provisions to 
assure automatic adoption of future changes in the OPTN/SRTR data 
submission and outcome measure policies through issuance of Program 
Notices.
    Response: The SRTR refines their methodology on an ongoing basis. 
For example, the SRTR reassesses the methodology's risk adjustment 
factors periodically and makes changes based on research and changes in 
the field of transplantation. The SRTR also adds or changes data 
sources, as appropriate. Periodically, the OPTN asks the SRTR to look 
into statistical techniques to improve data analysis. Such changes will 
not require us to engage in rulemaking. If the OPTN makes a substantive 
change to its policies regarding the methodology or chooses a different 
methodology for calculation of outcomes, we will assess the change to 
determine whether we should adopt it. For example, if the OPTN were to 
change the threshold for the p-value, and we determined that the change 
to the threshold would be appropriate for our outcome requirements, we 
likely would be required to engage in rulemaking so that the public 
would have the opportunity to comment. Based on our knowledge of the 
OPTN's past practices, we do not expect substantive changes to occur 
frequently. In fact, since the OPTN published the first annual report 
containing transplant center-specific outcomes data and transplant 
survival rates in 1992, there has been only one major change in the 
methodology used to measure outcomes--the change from the OPTN 
methodology to the SRTR methodology, which took place in 2002. We have 
made no changes based on these comments.

Risk-Adjustment Factors

    Comment: Many commenters expressed concern that the SRTR model does 
not include all the risk-adjustment factors impacting outcomes, for 
example, new immunosuppression protocols, organs from extended criteria 
donors (ECDs) and donors after cardiac death (DCDs), steatosis, and 
centers' participation in research. The commenters were concerned that: 
(1) Transplant centers may be penalized for using organs from ECDs and 
DCDs if using such organs leads to poorer outcomes; (2) centers may 
refuse to use such organs because they fear their outcomes will be 
affected; (3) centers may be penalized for participating in research 
studies that yield negative outcomes; and (4) some centers may deny 
access to high-risk patients in order to meet the outcome measures.
    One peer reviewer also expressed concern that the SRTR model does 
not risk adjust for organs from DCD or ECD donors, which the reviewer 
said may need to be incorporated into the model to meet the needs of an 
increasingly aging recipient population.
    Response: We understand the commenters' and the peer reviewers' 
concerns. However, the SRTR methodology is not simply a list of 
covariates or values for parameter estimates. The SRTR revises risk-
adjustment factors periodically in response to trends in organ donation 
and transplantation. For example, it has already included ECD organs as 
one of the risk-adjustment factors in its outcome methodology model so 
that centers using ECD organs frequently are not disadvantaged. We are 
confident that the OPTN/SRTR will be able to develop appropriate risk-
adjusted outcome measures for DCD donor organs in the future. We made 
no changes based on these comments.

Appropriateness of Allowing a New Center to Use 1-Month Post-Transplant 
Data and Frequency of Subsequent Review of the Center's Post-Transplant 
Data

    We proposed that if a new transplant center hired an experienced 
team from another transplant center, we would permit the new center to 
request that we review its 1-month post-transplant patient and graft 
survival for all transplants performed in the previous 1-year period, 
if the following conditions were met: (1) The key members of the 
center's transplant team performed transplants at a Medicare-approved 
transplant center for a minimum of 1 year prior to the opening of the 
new center; (2) the transplant team met the human resources requirement 
at Sec.  482.98; and (3) the most recent SRTR report on the center did 
not contain 1-year post-transplant follow-up data on at least 9 
transplants of the appropriate organ type for the reported time frame.
    We proposed that if we approved a transplant center based on 1-
month post transplant outcomes data, we would re-evaluate the center 
when 1-year post-transplant data became available.
    We asked for comments on our proposal, as well as comments 
regarding the frequency with which we should re-

[[Page 15222]]

assess these new centers after they receive initial Medicare approval.
    Comment: Some commenters supported the idea of approving new 
centers based on 1-month post-transplant data. The three peer reviewers 
did not object to the proposal to review a new center's 1-month post-
transplant graft and patient survival outcome; however, they believed 
that reviewing a new center's 3-month or 6-month post-transplant data 
would provide more relevant information. One peer reviewer recommended 
an interim approval of new centers based on a 1-month post-transplant 
data review, pending a subsequent review of 3-month post-transplant 
data. Another peer reviewer recommended the comparison of projected 1-
year post-transplant graft and patient survival rates with the expected 
1-year post-transplant graft and patient survival rates, in addition to 
review of 1-month post-transplant data.
    Some commenters stated that 1-month post-transplant data may be 
more reflective of the transplant team's surgical outcomes than the 
quality of the transplant center. One peer reviewer suggested that 1-
month post-transplant data is too close to the date of the transplant 
and, thus, patient outcomes may not truly reflect the impact of the 
transplantation itself. The peer reviewer recommended that a 3-month 
post-transplant data review, in conjunction with three consecutive 
annual reviews, is a better marker for new center approval.
    Another peer reviewer stated that approval of new centers based on 
review of 1-month post-transplant data for approval of new centers 
would be ill-advised. The peer reviewer said that 1-month post 
transplant data likely reflect primarily surgical expertise and the 
quality and the thoroughness of pre-transplant evaluation, rather than 
the skill of the multi-disciplinary transplant team. The peer reviewer 
stated that the use of 1-month post-transplant data for approval of new 
centers should be allowed only when the new center has demonstrated 
acceptable 1-year post-transplant graft and patient survival rates in 
other established organ transplant programs. The peer reviewer said 
that having acceptable 1-year post-transplant graft and patient 
survival rates for a minimum of 9 transplants should be mandatory for a 
new center that has no other organ transplant experience. Some 
commenters stated that simply having an experienced surgeon or 
transplant team should not be sufficient to qualify a new center. One 
commenter said that there are other factors besides surgical or 
transplantation experience that we should use to assess a new 
transplant center's performance. Another commenter expressed concern 
that Medicare approval of new centers based on review of 1-month post-
transplant data would:
    (1) Create an incentive for transplant teams to move from center to 
center, thus causing disruption to transplant patient services, 
negatively impacting patient follow up, significantly undermining the 
financial and human resource investment of transplant centers, and 
increasing costs to the health care system; and
    (2) Raise patient safety issues, because experience indicates that 
it takes more than a year for a transplant center to develop and 
maintain a comprehensive transplant program.
    Response: The comments from peer reviewers and the public, as well 
as the recent, abrupt closure of a new kidney transplant center 
following an investigation by the California Department of Managed 
Health Care, have led us to the conclusion that approving new 
transplant centers based on a review of 1-month post-transplant 
outcomes data and the experience of the transplant surgeon and 
transplant physician would not serve the best interests of Medicare 
beneficiaries who need transplants.
    We share the commenter's concern that approving transplant centers 
based on 1-month post-transplant data has the potential to harm patient 
care. Most important, we have been unable to identify a need for 
centers to be approved quickly using abbreviated data.
    Establishing a new transplant center is not an easy task. Clearly, 
a transplant center must provide non-surgical support services for 
transplant patients and perform many functions in addition to the 
transplant surgery itself, including, but not limited to, nursing, 
nutrition counseling, social services, pharmacology, immunology, 
pathology, and radiology. In fact, the president of the managed care 
organization that recently shut down its new kidney center was quoted 
as saying that establishing a transplant program was much more 
difficult than anticipated and that the organization was na[iuml]ve to 
think the program could be established quickly.
    Furthermore, we believe it would be inadvisable to approve a new 
center based on the fact that the hospital in which the center is 
located has a successful center that transplants another type of organ, 
as one commenter recommended (unless there is a direct relationship 
between organ types, such as a kidney center that seeks approval as a 
pancreas center). The SRTR center-specific reports indicate that the 
performance of organ transplant centers is not always consistent within 
a multi-center transplant hospital. Within the same transplant 
hospital, some centers may have outstanding outcomes while some centers 
may have marginal or sub-optimal outcomes.
    Taking these factors into consideration, we believe it would be 
inappropriate for us to use the expertise of the key members of a 
transplant center's team as a proxy for the quality of a transplant 
center's overall operations.
    Consequently, we have eliminated proposed Sec.  482.80(b)(4) 
through (6). Under this final rule, we will use 1-year post-transplant 
patient and graft survival data to assess the performance of all 
transplant centers seeking initial Medicare approval.

Outcome Requirements for Heart-Lung, Intestine, and Pancreas Centers

    We requested comments on the appropriateness of having no outcome 
requirements for heart-lung, intestine, and pancreas centers. We also 
asked for recommendations for alternative methods to evaluate centers 
that transplant these types of organs.
    We proposed defining a heart-lung transplant center as a center 
that is located in a hospital with an existing Medicare-approved heart 
transplant center and an existing Medicare-approved lung transplant 
center that performs combined heart-lung transplants. We proposed 
defining an intestine transplant center as a Medicare-approved liver 
transplant center that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants. We proposed 
defining a pancreas transplant center as a Medicare-approved kidney 
transplant center that performs pancreas transplants alone or 
subsequent to a kidney transplant, as well as kidney-pancreas 
transplants. That is, we proposed that a Medicare-approved kidney 
transplant center would be permitted to perform all types of pancreas 
transplants.
    Comment: Some public commenters supported having no outcome measure 
requirements for heart-lung, intestine, and pancreas transplant centers 
since there are no risk-adjusted outcome measure models for these types 
of transplants. Three peer reviewers agreed with our proposal for 
heart-lung, intestine, and pancreas centers but added that once a risk-
adjusted outcome measure model becomes available in the

[[Page 15223]]

future, it should be applied to these centers.
    Response: Once the SRTR has developed risk-adjusted models for 
heart-lung transplants, intestine transplants, and pancreas 
transplants, we will consider establishing outcome measure criteria for 
the approval and re-approval of centers that perform these transplants.
    In the absence of risk-adjusted outcome measure models for these 
types of organ transplants, we believe the approach we proposed and 
have made final in this rule without change is most appropriate at this 
time.

Outcome Measures for Pediatric Transplants

    We requested comments on our proposed approach to evaluating 
pediatric transplant centers' outcomes and approving centers performing 
pediatric transplants.
    Comment: Some peer reviewers were concerned about pediatric 
centers' ability to maintain resources due to infrequent 
transplantation activities. A reviewer stated that the OPTN routinely 
peer reviews pediatric program case logs, and the peer reviewer 
recommended that the OPTN notify us about under-performing programs 
using pre-established thresholds.
    One commenter agreed with our proposal to apply outcome 
requirements for adult centers to centers performing pediatric 
transplants. However, one commenter voiced concern that the inability 
of pediatric centers to perform 9 transplants in a 2.5-year period (as 
required for the SRTR methodology to be valid) may prevent them from 
participating in Medicare. Nonetheless, the commenter urged the SRTR to 
continue analyzing pediatric 1-year post-transplant outcomes. The 
commenter encouraged the SRTR to develop evidence-based outcome 
guidelines by analyzing center-specific 1-year outcomes of pediatric 
patients transplanted over a 2.5-year period.
    Response: We intend to confer with the OPTN, as appropriate, about 
both pediatric and adult centers to ensure that we can effectively 
monitor the quality of transplant programs.

Proposed Process Requirements for Transplant Centers

Condition of Participation: Patient and Living Donor Selection 
(Proposed Sec.  482.90)

    We proposed requiring centers to use written patient selection 
criteria in determining a patient's suitability for placement on the 
waiting list for transplantation. We proposed that patient selection 
criteria must ensure fair and non-discriminatory distribution of 
organs.
    We proposed that before a patient is selected for a non-renal 
transplant, the transplant center must consider or employ all other 
appropriate medical and surgical therapies that might be expected to 
yield both short and long-term survival comparable to transplantation.
    We proposed that before a center places a patient on its waiting 
list, the center must ensure that the prospective transplant candidate 
receives a psychosocial evaluation and that the potential transplant 
candidate's medical record contains documentation of the candidate's 
blood type. (A psychosocial evaluation conducted by transplant centers 
of potential transplant recipients screens for issues that could affect 
the patient's compliance with the post-transplant treatment that is 
necessary to maximize the chances of a successful transplant, such as 
substance abuse or behavioral or psychiatric issues.) We also proposed 
that when a patient is placed on a center's waiting list, the center 
must document in the patient's medical record the patient selection 
criteria used.
    We proposed that if a center performs living donor transplants, the 
center must use written donor selection criteria in determining the 
suitability of living donors for donation. We proposed that the living 
donor selection criteria must be consistent with the general principles 
of medical ethics. We proposed that the transplant center must: (1) 
Ensure that a prospective living donor receives a medical and 
psychosocial evaluation prior to donation; (2) document in the 
transplant candidate's and living donor's medical records the living 
donor's suitability for donation; and (3) document that the living 
donor has given informed consent, as required under Sec.  482.102. The 
psychosocial evaluation conducted by a transplant center of a potential 
living donor assesses the donor's motivation and his or her 
understanding of the donation process and post-donation treatment. A 
center assesses whether the potential living donor has any behavioral 
or psychiatric issues that could influence the decision to donate and 
whether he or she is being pressured to donate.
    Following are summaries of the comments we received and our 
responses.
    Comment: Many commenters supported the proposed written patient and 
living donor selection requirements. Commenters stated that the 
requirements are reasonable and that many centers already have these 
selection criteria in place. One commenter applauded us for giving 
transplant centers the flexibility to develop their own criteria. The 
commenter commended us for refraining from defining patient selection 
criteria. However, some commenters opposed the requirement for 
transplant centers to have written patient and living donor selection 
criteria. Commenters stated that the requirements are too prescriptive 
and would be burdensome.
    Response: We disagree that these requirements are too prescriptive. 
In fact, current Medicare requirements for heart, liver, and lung 
transplant centers have specific patient selection criteria guidelines 
for centers to use to select patients for transplantation. Conversely, 
this final rule permits transplant centers to develop the criteria that 
best fit the needs of their patients and gives centers the flexibility 
to change their criteria as transplant medicine changes over time. We 
will no longer require transplant centers to use the existing patient 
selection criteria. As long as their patient selection criteria are 
fair and non-discriminatory, transplant centers are free to develop 
their criteria based on the medical judgment of their transplant 
physicians and surgeons.
    Comment: Some commenters said they believe that written patient 
selection criteria may pose undue risk to centers when the criteria 
used to select a transplant patient deviate from the transplant 
center's written criteria. Another commenter stated that the disclosure 
of deviations from patient selection criteria will pose legal risks for 
transplant centers.
    Response: We disagree with the commenters that written patient and 
living donor selection criteria will pose undue legal risk to centers. 
Instead, we believe that well-written patient and living donor 
selection criteria can reduce the legal risk for a transplant center, 
as long as the center adheres to its criteria or documents the reason 
why it has deviated from its criteria. Given the scarcity of organs, we 
believe established written patient selection criteria, at a minimum, 
will ensure equity and consistency when transplant risk-benefit 
decisions are made. No change was made based on these comments.
    Comment: Some commenters stated that patient selection is a medical 
judgment and that there are gray areas, subtleties, and subjectivities 
involved in selecting patients for transplants.
    Response: We acknowledge that selecting patients for 
transplantation is the responsibility of the transplant surgeon and 
that transplant surgeons

[[Page 15224]]

must exercise their medical judgment when weighing the risks and 
benefits of transplantation. This final rule does not dictate how 
transplant candidates should be selected for placement on the waiting 
list and transplantation. Although we require transplant centers to 
have written patient selection criteria, transplant centers are free to 
include a process for justifying exceptions to the selection criteria.
    Comment: A few commenters stated that the proposed requirement for 
written patient criteria is duplicative of the OPTN patient listing 
policies. The commenters said that a center's adherence to the OPTN 
policies should satisfy our patient selection criteria.
    Response: The OPTN policies for patient placement on the waiting 
list focus mainly on the criteria for organ allocation and not on the 
criteria for placement on or exclusion from a center's waiting list. We 
believe that if transplant centers adhere to OPTN policies and comply 
with the patient selection criteria requirement in this final rule, 
they will place patients on their waiting lists appropriately. 
Therefore, we have finalized the patient selection criteria requirement 
as proposed.
    Comment: A commenter stated that patient selection for transplants 
is usually a medical judgment based on guidelines developed by 
professionals. Guidelines change from time to time. A commenter 
recommended the Patient Care and Education Guidelines developed by the 
American Society of Transplantation as a helpful resource for 
transplant decisions.
    Response: We support the concept of incorporating professional 
guidelines into a transplant center's transplant candidate selection 
policies, as the center deems appropriate. We expect that transplant 
centers will revise their policies periodically as needed. We have made 
no changes based on this comment.
    Comment: A commenter stated that we should encourage patients to 
take some responsibility for their own care. The commenter suggested 
that in the transplant candidate evaluation process provision, we 
should include some patient self-management provisions.
    Response: We agree with the commenter that transplant candidates 
should share responsibility for their own care. Transplant centers are 
free to incorporate this concept in their patient evaluation policies. 
However, including such a requirement in regulations would be 
unnecessarily prescriptive.
    Comment: Some commenters opposed the requirement that a transplant 
center must employ or consider all other appropriate medical and 
surgical therapies that might be expected to yield both short and long-
term survival comparable to transplantation before a patient is 
selected for placement on the waiting list. The commenters said this 
practice interferes with medical judgment and may place transplant 
centers at legal risk. A few commenters requested an exemption for 
kidney, heart, and pancreas transplant centers from this requirement 
because transplant decisions for these organ types are sometimes based 
on quality of life considerations, rather than survival alone. 
Commenters pointed out that medical and surgical therapy changes 
constantly, and it is difficult for transplant centers to set the upper 
and lower parameters in exhausting all available therapies before 
placing patients on the waiting list. Some commenters asked us to 
define ``all other appropriate medical and surgical therapies'' and 
questioned how compliance with this requirement would be determined.
    Response: We understand the commenters' concerns that some 
transplant risk-benefit decisions are not based on survival alone and 
that it may be difficult for transplant centers to establish parameters 
for alternative medical and surgical therapies. Therefore, we are not 
finalizing our proposed requirement at Sec.  482.90(a)(1).
    Comment: Some commenters supported our proposal to require a 
psychosocial evaluation for prospective transplant candidates and 
suggested that a transplant center should designate qualified staff to 
perform the evaluation. One commenter suggested that prospective 
transplant candidates who have a history of psychiatric illness and 
substance abuse should be further evaluated by a psychologist or 
psychiatrist.
    Response: We agree that a psychosocial evaluation should be 
performed by qualified staff. For good patient care, we expect that the 
individual who performs a psychosocial evaluation of a transplant 
candidate or prospective living donor will make a referral for further 
evaluation if a patient shows symptoms of, or has a history of, 
psychiatric illness or substance abuse. However, we have made no 
changes based on this comment.
    Comment: Many commenters recommended changing our proposed language 
to state that a prospective transplant candidate or prospective living 
donor must receive a ``qualified social worker evaluation'' because the 
proposed language ``psychosocial evaluation'' is too ambiguous and does 
not indicate who conducts the evaluation. Other commenters recommended 
that a qualified social worker should be designated to perform the 
evaluation using the Standards for Social Work Services in ESRD 
Facilities developed by the ESRD Network of Texas, Inc. as the 
standardized assessment tool.
    Response: We appreciate the commenters' recommendations. However, 
since there is more than one category of qualified professional who can 
conduct a psychosocial evaluation of a prospective transplant 
candidate, we have chosen to give transplant centers the flexibility to 
designate the type of qualified individual who will conduct the 
psychosocial evaluation. This individual may be a qualified social 
worker or another qualified individual.
    In our view, there is no standardized psychosocial evaluation tool 
that would be applicable to all prospective organ transplant 
candidates. Therefore, this final rule, as proposed, provides a 
transplant center with the flexibility to select a standardized 
psychosocial evaluation tool or to devise its own psychosocial 
evaluation tool. We have made no changes based on this comment.
    Comment: One commenter stated that it is impractical and 
inappropriate to require transplant centers to conduct a psychosocial 
evaluation of some prospective transplant candidates, such as infants 
and very small children, as well as patients who are acutely ill with 
fulminate hepatic failure or acute cardiomyopathy.
    Response: In nearly all cases, a transplant center should ensure 
that patients receive a psychosocial evaluation prior to placement on 
the center's waiting list. However, we agree with the commenters that 
conducting a psychosocial evaluation is not always possible, for 
example, in emergency situations or when the patient is very young. 
Therefore, we have revised the regulation text at Sec.  482.90(a)(1) to 
state that ``prior to placement on the center's waiting list, a 
prospective transplant candidate must receive a psychosocial 
evaluation, if possible.'' We expect transplant centers to perform 
psychosocial evaluations in every situation in which it is possible to 
do so.
    Comment: A few commenters supported the requirement for determining 
and documenting a transplant candidate's blood type in medical records 
prior to being placed on the waiting list. However, one commenter 
suggested that we should refer to the UNetSM system to 
determine a candidate's ABO blood type, instead

[[Page 15225]]

of establishing a new blood type documentation requirement.
    Response: We are not establishing a new blood type documentation 
requirement. We require only that before a transplant center places a 
transplant candidate on its waiting list, the candidate's medical 
record must contain documentation of the candidate's blood type. 
Similarly, OPTN policies require a transplant program to be responsible 
for ensuring the accuracy of candidate ABO data on the waiting list. 
OPTN policies also include on-line verification of a candidate's ABO 
data against the source document by an individual other than the person 
initially entering the candidate's ABO data in UNetSM. The 
OPTN expects a transplant program to maintain records documenting that 
such separate verification of the source document against the entered 
ABO has taken place and make such documentation available for audit. 
Our requirements complement these OPTN policies. The individual who 
verifies the source document (which could be the determination of blood 
type in the candidate's medical record against the UNetSM) 
may simply annotate the verification in the medical record.
    Comment: A commenter questioned the rationale for requiring 
documentation of the patient selection criteria used. One commenter 
stated that documenting patient selection criteria would be time-
consuming and a departure from current practice. Another commenter 
suggested that adherence to some written basic patient selection 
criteria or cross-referencing the patient selection criteria should be 
adequate evidence of compliance. A few commenters stated that the 
documentation of patient selection criteria, including the evaluation 
process and analysis of extensive medical work-up, would add 
administrative burden to transplant centers and increase Medicare 
expenses.
    Response: The rationale for requiring documentation of the patient 
selection criteria used is to ensure that the transplant center's 
written patient selection policies and procedures are consistently 
implemented and that this is reflected in medical records. We agree 
that repeating a written narrative of all previous pre-transplant 
evaluation processes and medical work-ups would be burdensome. However, 
in documenting the patient selection criteria used, a transplant center 
may choose to use electronic formats, forms, or checklists to indicate 
the applicable criteria, as set forth in the center's own policies and 
procedures manual. We believe that any administrative burden associated 
with the patient selection criteria documents will be minimal and will 
not raise Medicare expenses appreciably.
    Comment: A few commenters supported the requirement that living 
donor selection criteria must be consistent with general medical 
ethics. Commenters stated that selection criteria are important in 
bringing some standardization to the living donor evaluation and 
selection processes. A commenter recommended giving flexibility to 
transplant centers to evaluate medical ethics issues on a case-by-case 
basis. However, one commenter stated that there is no consensus on what 
constitutes medical ethics. Another commenter requested more explicit 
clarification of the meaning of general medical ethics.
    Response: We expect a transplant center to assess the prospective 
living donor carefully to ensure, insofar as possible, that donation 
will not cause long-term harm to the individual's health. Furthermore, 
we expect transplant centers to apply the ethical principle of 
``equipoise'' to assess whether the benefits to both the donor and the 
recipient outweigh the risks associated with the donation and the 
transplantation. We believe the provisions set forth in this final rule 
provide flexibility for transplant centers to evaluate every 
prospective living donor individually, using the same medical ethics 
they would use in providing health care to any patient. No changes were 
made based on these comments.
    Comment: A commenter questioned if Internet donor matching is 
ethical.
    Response: The commenter is correct that the transplant community 
has not reached consensus on the ethics of certain donation practices, 
such as Internet donor matching. However, such issues are beyond the 
scope of this final rule.
    Comment: Some commenters suggested adopting the OPTN Ad Hoc Living 
Donor Committee Living Liver and Kidney Donor Evaluation Guidelines or 
the Living Donor Evaluation Criteria developed by the American Society 
of Transplantation.
    Response: We support the concept of incorporating professional 
guidelines into a transplant center's living donor selection policies. 
However, we believe incorporating the suggested guidelines or 
evaluation criteria into this final rule would be too prescriptive and 
would not provide centers with sufficient flexibility. We made no 
changes based on this comment.
    Comment: Although some commenters supported medical and 
psychosocial evaluation of living donors, one commenter did not support 
the requirement for a living donor to receive a psychosocial 
evaluation, as it might delay transplantation and would add to the cost 
of the transplantation. The commenter noted that, in the case of parent 
to child donation, the psychosocial evaluation would not be warranted.
    Response: Transplant centers are free to include a process in their 
policies and procedures to respond to emergency situations when it may 
not be possible to conduct a psychosocial evaluation prior to donation. 
However, in the absence of such a situation, we expect transplant 
centers to conduct psychosocial evaluations of all prospective living 
donors. An evaluation can assist the prospective living donor in 
evaluating the pros and cons of donating and the potential 
psychological impact of donating and thus aid the individual in making 
an appropriate donation decision. Even a parent donating to a child may 
feel conflicted; for example, a parent may worry about the possible 
impact of the parent's donation on other children in the family.
    Comment: One commenter supported the documentation of living donor 
suitability in medical records. However, some commenters had concerns 
that such documentation in the transplant candidate's medical records 
would compromise the privacy of the donor's individually identifiable 
health information and violate the HIPAA regulations, putting 
transplant centers at legal risk. Another commenter stated that this 
requirement deprives the potential living donor of an exit out of the 
donation process if the individual is reluctant to donate but prefers 
the transplant candidate to think he or she cannot donate for medical 
reasons.
    Response: We believe the commenters have valid concerns, and we 
agree that documentation of a living donor's suitability for donation 
in the transplant recipient's medical records would be inappropriate. 
Therefore, we have eliminated the proposed requirement at Sec.  
482.90(b)(2) to document the transplant recipient's medical record with 
the living donor's suitability for donation. However, we have finalized 
our proposal to require documentation of the living donor's suitability 
for donation in the living donor's medical record. (See Sec.  
482.90(b)(2).)

Availability of Patient Selection Criteria

    In the proposed rule, we requested comments on whether transplant 
centers should be required to make the

[[Page 15226]]

patient selection criteria available to patients routinely or upon 
request.
    Comment: One commenter stated that providing transplant patients 
with patient selection criteria would restore public trust in the 
transplant system and ensure fairness in organ allocation. However, 
another commenter stated that providing candidates with patient 
selection criteria may set unrealistic expectations in the complex 
organ allocation and transplantation process. A few commenters 
recommended that a copy of the patient selection criteria should be 
given to patients only if requested.
    Response: We agree that the knowledge of a transplant center's 
patient selection criteria would help a patient to better understand 
his or her treatment options. However, given that transplantation is 
not a straightforward decision, we agree with the commenter who 
expressed concern that providing the patient selection criteria to 
patients may lead to misunderstanding or give some patients unrealistic 
expectations of their likelihood of receiving a transplant. Some 
patients may want to rely on their surgeons and physicians to give them 
advice and recommendations about transplantation. Therefore, this final 
rule requires a transplant center to provide a copy of its patient 
selection criteria to a patient only upon the patient's request.
    We are sympathetic to the view of the commenter who said that 
providing copies of patient selection criteria to patients would ensure 
fairness in organ allocation. We believe that additional transparency 
in the selection process can further the goal of equity in 
transplantation and give dialysis facilities a tool to ensure that 
referral of dialysis patients to kidney transplant centers for 
evaluation is fair and non-discriminatory. That is, once a dialysis 
facility knows the specific patient selection criteria used by each 
kidney transplant center in its vicinity, it can better ensure that it 
refers all patients who may be eligible for transplantation. Therefore, 
we have added a requirement to this final rule specifying that a kidney 
transplant center must provide a copy of its transplant patient 
selection criteria to a transplant candidate or a dialysis facility, at 
the request of the patient or the facility. (See Sec.  482.90(a)(4).)
    We note that a patient who believes that a transplant center's 
patient selection criteria are unfair or discriminatory or that a 
transplant center has not followed its patient selection criteria may 
find a remedy in the grievance process of the hospital in which the 
transplant center is located. Section 482.13, Patient Rights, requires 
hospitals to protect and promote each patient's rights. Section 
482.13(a)(2) further requires that hospitals establish a grievance 
process for the prompt resolution of patient grievances and that the 
hospital's grievance procedures are clearly explained to the patient.

Condition of Participation: Organ Recovery and Receipt (Proposed Sec.  
482.92)

    We proposed that transplant centers must have written protocols to 
validate donor-recipient matches and other vital data for deceased 
organ recovery, organ receipt, and living donor transplantation. We 
proposed assigning responsibility to the transplanting surgeon for 
ensuring the medical suitability of donor organs for transplantation 
into the intended recipient.
    We proposed that a transplant center's organ recovery team would 
have to review and compare the recipient and donor data with the 
recipient blood type and other vital data before recovery took place. 
We also proposed requiring that, when an organ arrives at a transplant 
center, the transplanting surgeon and at least one other individual at 
the transplant center must verify prior to transplantation that the 
donor's blood type and other vital data indicate that the donor's organ 
is compatible with transplantation of the intended recipient.
    We proposed that if a center performed living donor transplants, 
the transplanting surgeon and at least one other individual at the 
transplant center would be required to verify that the living donor's 
blood type and other vital data indicated that the donor's organ is 
compatible for transplantation of the intended recipient, immediately 
before the removal of the living donor organ(s) and, if applicable, 
prior to the removal of the recipient's organ(s).
    Following are summaries of the comments we received and our 
responses.
    Comment: Some commenters supported the proposed requirement for 
transplant centers to have written protocols to validate donor-
recipient compatibility in organ recovery, receipt, and transplantation 
to prevent unintended transplantation of organs mismatched by blood 
type. However, a commenter stated that protocols for validation of data 
may pose a legal risk for transplant centers.
    Response: A crosscheck verification of the donor's blood type with 
the blood type of the intended recipient is a critical step in organ 
allocation and transplantation. Therefore, in this final rule, as we 
proposed, we require transplant centers to have written protocols to 
ensure that this essential process takes place. We believe that 
consistent application of such sound protocols ultimately will reduce 
legal risks for transplant centers.
    Comment: A commenter stated that it is impossible to be inclusive 
of all possible scenarios encountered in organ recovery; therefore, the 
use of a written protocol for organ recovery would be limited.
    Response: We recognize that the unexpected may happen during organ 
recovery. However, a well-written organ recovery protocol should 
anticipate as many of these scenarios as possible.
    Comment: Some commenters disagreed that the transplant surgeon 
should be fully responsible for suitability of donor organs during 
organ recovery because:
    (1) Information provided by an OPO may not be accurate;
    (2) At the time of organ recovery, the identity of the intended 
recipient may not be known; and
    (3) At the time of organ recovery, information about the organ 
donor may not be complete.
    Response: The requirement does not mean that the transplant surgeon 
is responsible for the suitability of donor organs prior to or during 
recovery. The transplant surgeon is responsible for ensuring the 
medical suitability of a donor organ for transplantation into the 
intended recipient only after the organ has arrived at the transplant 
center. If the transplant surgeon makes the determination of medical 
suitability based on inaccurate information provided by the OPO about 
the donor organ (for example, the paperwork that accompanies the organ 
to the transplant center is marked with the wrong blood type), the 
transplant surgeon will not be held responsible for his or her 
determination of medical suitability.
    Comment: A commenter suggested that the transplant coordinator 
should be responsible for blood type verification.
    Response: Transplant centers may delegate this responsibility to 
transplant staff or the transplant coordinator. No change was made 
based on this comment.
    Comment: Some commenters stated that the proposed blood type 
validation is duplicative of OPTN policies; therefore, additional 
requirements would not be necessary. Some commenters suggested that the 
OPTN policies and Medicare requirements should be consistent.
    Response: The commenters are correct that our requirement is 
similar to the OPTN policy, which requires a

[[Page 15227]]

transplant center, upon receipt of an organ and prior to 
transplantation, to perform and document crosscheck verification of the 
donor's blood type with the blood type of the intended recipient. As we 
have stated previously in this preamble, with the exception of OPTN 
data submission requirements, OPTN policies are not enforceable unless 
they are approved by the Secretary under 42 CFR 121.4.
    Comment: Some commenters suggested that our proposals for organ 
recovery were unnecessary. For example, a commenter stated that organ 
procurement procedures start before the recipient is identified or the 
transplant center is notified. Another commenter stated that many large 
OPOs already have developed protocols for organ recovery teams that 
recover organs for the OPO or for transplant centers, which means that 
transplant centers would have minimal involvement in the organ recovery 
process. However, another commenter agreed with our proposal and said 
that a transplant center's recovery team should validate donor and 
recipient blood type and other vital data before organ recovery takes 
place.
    Response: We recognize that in many cases, transplant centers may 
have little involvement in the process of organ recovery. Therefore, we 
have revised the regulation text at Sec.  482.92(a) to reflect that 
when the intended recipient is known, and the transplant center sends a 
team to recover organ(s), the transplant center's recovery team must 
review and compare the donor data with the recipient blood type and 
other vital data before organ recovery takes place.
    Comment: A commenter suggested that instead of requiring at least 
one other individual to verify donor-recipient blood type and vital 
information, we should specify that the individual must be a licensed 
health care professional.
    Response: We agree with the commenter. We have changed the 
regulatory text at Sec.  482.92(b) to require that after an organ 
arrives at a transplant center, prior to transplantation, the 
transplanting surgeon and another licensed health care professional 
must verify that the donor's blood type and other vital data are 
compatible with transplantation of the intended recipient. In addition, 
we have changed the regulatory text at Sec.  482.92(c) to say that if a 
center performs living donor transplants, the transplanting surgeon and 
another licensed health care professional at the center must verify 
that the living donor's blood type and other vital data are compatible 
with transplantation of the intended recipient immediately before the 
removal of the donor organ(s) and, if applicable, prior to the removal 
of the recipient's organ(s). Since cross checking donor and recipient 
information generally is performed in the operating room just prior to 
transplantation, nurses and other licensed health care professionals 
should be readily available.

Condition of Participation: Patient and Living Donor Management 
(Proposed Sec.  482.94)

    We proposed that transplant centers must have written patient 
management policies for the pre-transplant, transplant, and discharge 
phases of transplantation. We proposed that if a center performs living 
donor transplants, it must have written donor management policies for 
the donor evaluation, donation, and discharge phases of the living 
organ donation. We proposed that a transplant center must ensure that 
each transplant patient and living donor is under the care of a 
multidisciplinary patient care team coordinated by a physician 
throughout all phases of the transplantation or living donation.
    We proposed that transplant centers must keep their waiting lists 
current, including updating waiting list patients' clinical information 
on an ongoing basis. We also proposed that a transplant center must 
remove a patient from its waiting list if the patient receives a 
transplant, if the patient dies, or if there is any other reason that 
the patient should no longer be on a center's waiting list.
    We proposed requiring transplant centers to notify the OPTN of a 
patient's removal from the center's waiting list no later than 24 hours 
after the removal.
    We proposed that transplant centers must maintain up-to-date and 
accurate patient management records for each patient who receives an 
evaluation for placement on a center's waiting list and who is admitted 
for organ transplantation. For each patient who receives an evaluation 
for placement on a center's waiting list, we proposed that the center 
must document in the patient's record that the patient is informed of 
his or her transplant status, including notification of: (1) The 
patient's placement on the center's waiting list; (2) the center's 
decision not to place the patient on its waiting list; or (3) the 
center's inability to make a determination regarding the patient's 
placement on its waiting list because further clinical testing or 
documentation is needed.
    We proposed that once a patient is placed on a center's waiting 
list, the center must document in the patient's record that the patient 
has been notified of: (1) His or her placement status (at least once a 
year, even if there was no change in the patient's placement status); 
and (2) his or her removal from the waiting list for reasons other than 
transplantation or death no later than 10 days after removal.
    We proposed that kidney transplant centers must document in the 
patient's record that both the patient and the patient's usual dialysis 
facility have been notified of the patient's transplant status and of 
any changes in the patient's transplant status.
    We proposed that when a patient is admitted for transplantation, 
the patient's record must contain written documentation of 
multidisciplinary patient care planning during the pre-transplant 
period and multidisciplinary discharge planning for the patient's post-
transplant care.
    We proposed that transplant centers must make social services, 
furnished by qualified social workers available to transplant patients, 
living donors, and their families. We proposed that a qualified social 
worker is an individual who meets licensing requirements in the State 
in which he or she is practicing and: (1) Has completed a course of 
study with specialization in clinical practice and holds a master's 
degree from a graduate school of social work accredited by the Council 
on Social Work Education; or (2) has served for at least 2 years as a 
social worker, 1 year of which was in a transplantation program, and 
has established a consultative relationship with a social worker.
    We proposed that transplant centers must make nutritional 
assessment and diet counseling services furnished by a qualified 
dietitian available to all transplant patients and living donors.
    We proposed that a qualified dietitian is an individual who: (1) Is 
eligible for registration by the American Dietetic Association under 
its requirements in effect on June 3, 1976 and has at least 1 year of 
experience in clinical nutrition; or (2) has a baccalaureate or 
advanced degree with major studies in food and nutrition or dietetics 
and has at least 1 year of experience in clinical nutrition.
    We also are responding to comments we received on the ESRD proposed 
rule from dialysis facilities relating to transplant referral tracking 
of dialysis patients and the grandfather requirement for social 
workers. Although these comments were submitted along with comments on 
the ESRD proposed rule (February 4, 2005, 70 FR 6184), we are 
responding to them in the preamble to this final rule because they are 
relevant to our

[[Page 15228]]

proposed requirements for notification of waiting list patients and our 
proposed requirements for social workers.
    Following are summaries of the comments we received and our 
responses to the comments.
    Comment: Commenters agreed that transplant centers should play an 
active role in the care and management of transplant patients. Some 
commenters suggested that transplant centers should be required to 
provide pre-transplant and post-transplant care to transplant 
recipients in conjunction with the recipient's local provider team. 
However, many commenters stated that transplant centers should not be 
held accountable for transplant patients' pre- and post-transplant care 
because many waiting list patients do not live near the transplant 
center and are cared for by their local providers, particularly in the 
case of dialysis patients. Kidney transplant patients usually receive 
their pre- and post-transplant care from their local nephrologists and 
dialysis facilities. Commenters stated that pre-transplant care 
planning for kidney patients is the responsibility of the dialysis 
facilities where the patients receive care.
    Response: As stated previously, we agree with the commenters that 
the care of transplant patients is best coordinated by local health 
care providers and transplant centers. Transplant patients require 
clinical evaluation before being placed on the waiting list, clinical 
care while they are on the waiting list, and follow-up monitoring after 
transplantation. In most cases, while transplant candidates are waiting 
for suitable organs, they continue to receive non-transplant-related 
routine medical care from their local health care providers and (for 
kidney patients) dialysis facilities, rather than from the transplant 
center where they are listed. Therefore, based on public comments, we 
have not finalized our proposed requirement at Sec.  482.94 that 
transplant centers must have written patient management policies for 
the pre-transplant phase of transplantation or our proposed requirement 
that they must provide pre-transplant care to transplant patients.
    We agree with the commenters that transplant patient management is 
better coordinated with the transplant patient's local providers, and 
we expect that for the most part, this is already a standard practice. 
However, we see no reason to prescribe explicitly how transplant 
centers should work with other providers, with the exception of 
dialysis facilities.
    The relationship between dialysis facilities and kidney transplant 
centers is unique because dialysis facilities treat and monitor their 
patients more frequently than other health care providers. Any changes 
in a dialysis patient's' clinical status may affect his or her 
transplant suitability. Thus, it is important for kidney transplant 
centers to have open and frequent communication with dialysis 
facilities to ensure that all transplant-related issues are 
communicated clearly to the patient and to the patient's provider(s) of 
care. Based on these comments, we have added a requirement at Sec.  
482.104(a) that a kidney transplant center must have written policies 
and procedures for ongoing communication with dialysis patients' local 
dialysis facilities.
    Coordination also ensures that the transplant center has the 
information about the patient's status that it needs to keep its 
waiting list and the OPTN's waiting list current. For example, a 
patient may have to be removed from the waiting list because he or she 
has become too ill to receive a transplant. Therefore, we are 
finalizing the proposed requirement at Sec.  482.94(c) as follows. 
Section 482.94(c)(1) specifies that for each patient who receives an 
evaluation for placement on a center's waiting list, the center must 
document in the patient's record that the patient (and in the case of a 
kidney patient, the patient's usual dialysis facility) has been 
informed of his or her transplant status, including notification of: 
(i) The patient's placement on the center's waiting list; (ii) The 
center's decision not to place the patient on its waiting list; or 
(iii) The center's inability to make a determination regarding the 
patient's placement on its waiting list because further clinical 
testing or documentation is needed. Section 482.94(c)(2) requires that 
if a patient on the waiting list is removed from the waiting list for 
any reason other than death or transplantation, the transplant center 
must document in the patient's record that the patient (and in the case 
of a kidney patient, the patient's usual dialysis facility) was 
notified no later than 10 days after the date the patient was removed 
from the waiting list
    For post-transplant care, we expect a transplant center to use the 
discharge planning process to coordinate transplant-related follow-up 
care. (See Sec.  482.94(c)(3)(ii).) As a general rule, patients receive 
several months of post-transplant care from the transplant center that 
performed the transplant, even if they do not live near the transplant 
center. After that, patients often continue to receive care from the 
transplant center for an extended period of time in conjunction with 
their local physician or dialysis center. Coordination of care ensures 
that the transplant center will have access to the patient follow-up 
data it needs to abide by the OPTN data collection and submission 
policies.
    Comment: One commenter stated that the provision for 
multidisciplinary patient care planning is overly detailed and would 
place a burden on centers.
    Response: We disagree with the commenters. We believe the 
multidisciplinary patient care planning provision proposed at Sec.  
482.94(c)(4) is flexible and general in nature. We believe the 
requirements will allow a transplant center to assemble a 
multidisciplinary patient care team using in-house hospital staff, 
which should create little or no extra burden. Therefore, we are 
finalizing this requirement as proposed.
    Comment: One commenter stated that the proposed patient care 
requirements are duplicative of the JCAHO survey standards for 
inpatient care planning and discharge planning. Another commenter noted 
that the OPTN policies already address transplant care and patient 
management guidelines.
    Response: We agree that there are similarities between the JCAHO 
survey standards for inpatient care planning and discharge planning and 
our requirements for patient care in this final rule. However, some 
requirements in this final rule (such as living donor care, management 
of the waiting list, and patient records) are absent from JCAHO's 
survey standards for acute care hospitals. Furthermore, even if 
Medicare requirements were identical to JCAHO standards and OPTN 
policies, this fact would not eliminate the need to incorporate the 
requirements into our regulations because JCAHO standards and the 
OPTN's policies are not legally enforceable by CMS.
    Comment: Many commenters stated that kidney transplant centers 
should be exempt from the requirement for a written long-term care plan 
because kidney transplant candidates are usually cared for by their 
referring physicians, nephrologists, social workers, dietitians, and 
dialysis facilities while awaiting transplants. Some commenters 
suggested that instead of developing a care plan, kidney transplant 
centers should be required only to obtain a copy of the patient's long-
term care plan from the dialysis facility and keep it with the 
transplant candidate's medical records.
    Response: The commenters may have misunderstood the proposed 
patient management requirement. We are not requiring transplant centers 
to develop long-term care plans for transplant patients. We agree that 
this is the

[[Page 15229]]

responsibility of each patient's local health care providers and 
dialysis facility, as appropriate. As stated earlier, we strongly 
encourage transplant centers to collaborate with local providers and 
dialysis facilities to tailor patient management policies to their 
patients' needs. Given that it is a standard practice for health care 
providers to request medical records from other providers who are 
actively treating their patients, we do not believe we need to require 
a transplant center to obtain a copy of the patient's long-term care 
plan from the dialysis facility, nor do we need to exempt kidney 
transplant centers from these requirements. No changes have been made 
to this final rule based on these comments.
    Comment: One commenter supported the proposal that living donors 
should be under the care of a multidisciplinary team to safeguard their 
interests and well-being. The commenter suggested that we should 
require centers to be responsible for living donors' post-discharge 
issues or complications and provide specialists to follow living 
donors.
    Response: Since some living donors may receive immediate post-
donation care in hospital units outside the transplant center, we want 
to ensure that living donor care is well coordinated.
    We expect transplant centers to coordinate follow-up care for 
living donors upon discharge as well. Although this final rule does not 
specifically delineate transplant centers' responsibilities for living 
donors' post-discharge care, we expect a transplant center to provide 
care, as needed, if a living donor experiences donation-related 
problems or complications post-discharge.
    Comment: Many commenters commended us for our clarity in describing 
the waiting list management requirements that would positively impact 
the organ allocation system. The commenters stated that it is important 
for transplant centers to update the status of waiting list patients 
continuously to increase the efficiency of organ allocation and 
ultimately reduce organ wastage and organ discard rates. However, a few 
commenters stated that the waiting list management requirements are 
overly detailed and may put centers at legal risk.
    Response: We disagree that the waiting list management standard is 
overly detailed. The waiting list management requirements in this final 
rule are steps transplant centers must take to help the OPTN keep the 
waiting list current, so that: (1) Organ allocation is prioritized 
based on medical urgency and other relevant factors; (2) OPOs do not 
waste valuable time contacting centers about patients who should no 
longer be on the waiting list; and (3) organ wastage is minimized.
    We have no evidence that keeping its waiting list current will 
create a legal risk for a transplant center.
    Comment: One commenter suggested that we should specify how 
frequently transplant centers must update their waiting lists (that is, 
daily, weekly, or monthly).
    Response: We are not imposing an arbitrary timeframe for transplant 
centers to keep their waiting lists up to date. The availability of 
waiting list patients' clinical information varies from patient to 
patient, and clinical information may change frequently or 
infrequently. We expect transplant centers to update their waiting 
lists, including updates of clinical information and removal of 
patients from waiting lists an ongoing basis as the information becomes 
available. For clarity we have added ``on an ongoing basis'' at Sec.  
482.94(b) to emphasize that transplant centers must keep their waiting 
lists up to date.
    Comment: Some commenters expressed appreciation that we did not 
propose to mandate an annual evaluation of all patients on the waiting 
list. One commenter suggested that waiting list management should be 
clinically driven. That is, we should require centers to identify 
``high risk'' transplant candidates and evaluate them annually. A 
commenter suggested requiring centers to conduct periodic clinical re-
evaluations of transplant candidates to enhance updating of clinical 
information in those patients' medical records and their information on 
the waiting list.
    Response: We developed the requirement for transplant centers to 
update clinical information for their waiting list patients on an 
ongoing basis based on the assumption that updating of patients' 
clinical information is clinically driven. We understand that some 
patients are in critical condition, requiring more intense evaluation 
and monitoring, and other patients remain stable for longer periods of 
time. We expect transplant centers to keep their waiting lists updated 
accordingly. We expect that transplant centers will determine how often 
waiting list patients should be evaluated, based on the acuity of the 
individual patient. No changes were made in this final rule based on 
these comments.
    Comment: A commenter stated that it is unreasonable to expect large 
centers with long waiting lists to update all patients' clinical 
information on an ongoing basis because the requirement would be too 
burdensome.
    Response: We believe it is essential for a transplant center to 
stay abreast of its waiting list patients' clinical status and keep its 
waiting list updated on an ongoing basis so that when an organ offer is 
made, the transplant center knows the clinical status of the potential 
recipient. If a long waiting list is the reason for a center's failure 
to update waiting list patients' clinical status, the transplant center 
may need to re-evaluate its policies to determine if the number of 
patients on its waiting list is beyond its capacity to manage.
    Comment: Some commenters stated that managing a transplant center's 
waiting list is a very complex task and is already subject to OPTN 
oversight. Some commenters suggested that the OPTN should be the entity 
to set guidelines for waiting list management, and one commenter 
recommended that we should ask the OPTN to develop guidelines for 
transplant centers. Another commenter suggested that the OPTN should 
incorporate and publish the transplant waiting list management 
guidelines developed by the American Society of Transplant Surgeons 
(ASTS). Commenters said that our regulations should require only that 
transplant centers comply with OPTN waiting list policies.
    Response: As appropriate, we have included OPTN patient waiting 
list policies in this final rule for oversight and enforcement 
purposes. The OPTN has waiting list management policies that go beyond 
our requirements, including patient screening and listing criteria, 
waiting time modifications, multiple listings, and removal of 
transplant candidates from waiting lists. As we proposed at Sec.  
482.94(c), we have included some OPTN patient waiting list policies in 
this final rule for oversight and enforcement purposes. Suggestions 
regarding the OPTN's incorporation of specific guidelines, such as 
those developed by ASTS, fall outside the purview of this final rule 
and should be addressed to the OPTN.
    Comment: Some commenters stated that dialysis facilities do not 
always inform kidney transplant centers about changes in the clinical 
status of their dialysis patients. The commenters suggested that 
transplant centers, referring nephrologists, and dialysis facilities 
all should be held accountable for collaboration and communication 
regarding the clinical and listing status of patients on the waiting 
list. The commenter said that the collaboration process would help the 
transplant

[[Page 15230]]

center to keep patients' clinical information current.
    Response: We agree. Based on public comments, we have added a 
requirement for kidney transplant centers to have written policies and 
procedures for ongoing communication with dialysis patients' local 
dialysis facilities. (See Sec.  482.104(a).) We believe this 
requirement will resolve the commenters' concern about insufficient 
communication or lack of communication between transplant centers and 
dialysis facilities.
    Comment: A commenter stated that the requirement to notify the 
United Network of Organ Sharing (UNOS) (i.e., the OPTN Contractor) 
within 24 hours after a patient's removal from the center's waiting 
list does not take into consideration the inaccessibility of the 
UNet\SM\ over the weekend for on-call staff.
    Response: UNet\SM\ is available 24 hours a day, 7 days a week to 
the transplant community. Transplant centers need to provide access for 
on-call or weekend staff so that they can notify the OPTN timely 
outside of normal business hours.
    Comment: A commenter stated that timely notification to the OPTN 
about patients' removal from the waiting list is affected by data 
provided by dialysis facilities and local clinicians. One commenter 
suggested that we purchase software to help centers interface with 
dialysis facilities timely.
    Response: As we developed the proposed ESRD rule, we recognized the 
need for dialysis facilities to inform transplant centers about changes 
in the status of kidney transplant candidates.
    Although currently there is no software available to provide an 
interface between transplant centers and dialysis facilities, we do not 
expect transplant centers to have difficulty communicating with 
dialysis facilities.
    Comment: Some commenters supported the requirement for centers to 
notify each patient who is evaluated for transplant of his or her 
transplant status. However, some commenters stated that our patient 
notification requirements would be duplicative of OPTN policies.
    Response: Current OPTN bylaws for transplant hospitals include 
notification of patients in writing within 10 business days of: (1) A 
patient's placement on the waiting list, including the date the patient 
was listed; (2) completion of a patient's evaluation as a candidate for 
transplantation, if the evaluation has been completed and the patient 
will not be placed on the waiting list; or (3) removal from the waiting 
list as a transplant candidate for reasons other than transplantation 
or death. Further, transplant hospitals are expected to maintain 
documentation of these notifications and make the documentation 
available to the OPTN. As we proposed at Sec.  482.94(c)(2), we have 
incorporated similar notification policies into this final rule for 
purposes of oversight and enforcement. In addition, as proposed at 
Sec.  482.94(c)(3), this final rule requires a transplant center to 
document that it has notified the patient and dialysis facility, if 
applicable, if the transplant center is unable to make a decision 
whether to place the patient on the waiting list because further 
clinical testing or documentation is needed, as required by Sec.  
482.94(c)(1)(iii).
    Comment: A commenter stated that communicating waiting list status 
to patients via mail is too labor-intensive. A few commenters stated 
that our impact analysis in the proposed rule underestimated the cost 
of notifying patients and dialysis facilities. One commenter stated 
that the cost quoted to notify patients and dialysis facilities does 
not include management oversight time and expenses. Another commenter 
suggested that centers should use a letter to notify patients whether 
they will be placed on the waiting list and use phone calls for other 
types of communication.
    Response: As we proposed, the patient notification requirements in 
this final rule do not mandate how transplant centers will notify 
patients and dialysis facilities about patients' waiting list status. 
Transplant centers have the flexibility to determine how they will 
communicate such information to patients and dialysis facilities. 
Further discussion of the paperwork and the economic impact of these 
requirements are found in the Collection of Information and Impact 
Analysis sections of this preamble.
    Comment: Some commenters stated that the yearly requirement to 
notify transplant patients goes beyond the OPTN requirement and is 
unreasonable, costly, prescriptive, burdensome, and impractical.
    Response: We have carefully evaluated all the public comments we 
received on this issue and concluded that annual notification to 
patients would be unduly burdensome for transplant centers and is not 
necessary, as long as transplant centers can document that they 
notified transplant candidates, as appropriate, about the transplant 
candidate's placement status in accordance with Sec.  482.94(c) in this 
final rule. Therefore, we are not adopting the yearly notification 
requirement we proposed at Sec.  482.94(c)(2)(i).
    However, as we proposed at Sec.  482.94(c), we are requiring that 
if a transplant center evaluates a patient for placement on the waiting 
list, the center must document in the patient's record that the patient 
is informed of his or her transplant status, including notification of: 
(1) The patient's placement on the center's waiting list; or (2) the 
center's decision not to place the patient on its waiting list. 
Furthermore, as we proposed, once a patient is placed on a center's 
waiting list, the center must document in the patient's record that the 
patient is notified of his or her removal from the waiting list for 
reasons other than transplantation or death no later than 10 days after 
the patient's removal from the center's waiting list.
    To clarify that the requirement for notifying patients of their 
status after they have been evaluated for transplantation is the same 
for all patients but that a kidney patient's usual dialysis facility 
also must be notified, we have removed proposed section 482.94(c)(3) 
and added language to sections 482.94(c)(1) and (2). Section 
482.94(c)(1) now reads in part, ``For each patient who receives an 
evaluation for placement on a center's waiting list, the center must 
document in the patient's record that the patient (and in the case of a 
kidney patient, the patient's usual dialysis facility) has been 
informed of his or her transplant status, including notification of * * 
*.'' Section 482.94(c)(2) now reads in part, `` If a patient on the 
waiting list is removed from the waiting list for any reason other than 
death or transplantation, the transplant center must document in the 
patient's record that the patient (and in the case of a kidney patient, 
the patient's usual dialysis facility) was notified * * *.''
    Comment: A commenter stated that patients should take some 
responsibility for waiting list accuracy. Another commenter suggested 
that transplant patients should be given the ``Patient Bill of Rights 
and Responsibilities'' package in which the patient acknowledges in 
writing that he or she has the responsibility to keep the transplant 
center informed of his/her whereabouts.
    Response: We agree that waiting list patients should keep the 
center or centers where they are listed informed of their whereabouts 
and informed of any other relevant information. We encourage transplant 
centers to educate potential transplant candidates about their 
responsibilities. However, we have made no changes based on this 
comment.
    Comment: A commenter suggested that a center should be found in

[[Page 15231]]

compliance if it documents that it made a reasonable attempt to notify 
a patient without actually succeeding.
    Response: When notification of a waiting list patient or a 
prospective waiting list patient is required under this final rule, we 
expect the transplant center to make a concerted effort to locate and 
notify the patient. Nevertheless, we understand there may be 
circumstances in which the patient cannot be found. At a minimum, a 
transplant center should maintain documentation in the medical record 
that it made several attempts to contact the patient.
    Comment: Some individuals who commented on the ESRD proposed rule 
stated that dialysis facilities should relinquish transplantation 
referral tracking responsibility once the referral has been made. 
Commenters expressed concerns that some transplant centers do not 
communicate with dialysis facilities regularly. One commenter stated 
that transplant centers should provide dialysis facilities with the 
information they need to monitor transplantation status.
    Response: As we proposed, and as adopted in this final rule, a 
kidney transplant center bears considerable responsibility for patient 
tracking once a dialysis facility has referred a patient for 
evaluation. Section 482.94(c)(1) requires documentation of notification 
of the patient of his or her placement on the center's waiting list, 
the center's decision not to place the patient on its waiting list, or 
the center's inability to make a determination regarding the patient's 
placement on its waiting list because further clinical testing or 
documentation is needed. Under Sec.  482.94(c)(3), transplant centers 
must document in the patient's medical record that both the patient and 
the patient's local dialysis facility have been notified of the 
patient's transplant status and of any changes in the patient's 
transplant status (in accordance with Sec.  482.94(c)(1)).
    Comment: Many commenters supported the requirement that transplant 
centers must make social services furnished by qualified social workers 
available to transplant patients, living donors, and their families. 
Some commenters recommended that transplant centers should be required 
to provide transplant patients and living donors with ongoing access to 
qualified transplant social workers for continuity of care after 
discharge. One commenter inquired about the time frame for post-
transplant social services provided by transplant centers and the 
potential for Medicare reimbursement for the services.
    Response: Under the final rule and as we proposed, transplant 
centers are responsible for making social services furnished by a 
qualified social worker available to all transplant patients, living 
donors, and their families while a transplant patient or living donor 
is hospitalized. For Medicare beneficiaries (and their living donors), 
the services are often reimbursed. We did not propose requiring, nor 
does this final rule require, transplant centers to provide post-
discharge social services to all transplant recipients or living 
donors. Nonetheless, we expect any social services needed post-
discharge would be arranged through the discharge planning process. 
Some centers may choose to continue to provide such services to 
patients and living donors even though they may not be Medicare 
reimbursable. Medicare reimbursement for post-transplant social 
services outside the hospital setting falls outside the purview of this 
rule.
    Comment: Many commenters supported the proposed definition of a 
qualified social worker as an individual with a master's degree in 
social work (MSW). Commenters noted that the MSW degree requires an 
additional 900 hours of specialized training beyond a baccalaureate 
degree in social work, which prepares the individual with an MSW to 
work independently in the transplant setting where supervision and peer 
support is not always readily available.
    Many commenters recommended that we not allow social work 
experience to substitute for an MSW, as we proposed. We proposed 
permitting social workers to qualify if they served for at least 2 
years as a social worker, 1 year of which was in a transplantation 
program, and had established a consultative relationship with a social 
worker who qualified under our requirements for social workers with a 
master's degree. (See proposed Sec.  482.94(d)(2).) Conversely, in the 
ESRD proposed rule (70 FR 6184), we proposed eliminating a provision 
found in the current ESRD regulations at Sec.  405.2102 (which applies 
both to dialysis facilities and to kidney transplant centers), which 
defines a social worker, in part, as an individual who, ``* * * Has 
served for at least 2 years as a social worker, 1 year of which was in 
a dialysis unit or transplantation program prior to September 1, 1976 * 
* *''
    Many who commented on the ESRD proposed rule said that we should 
retain this ``grandfather clause'' for non-MSWs so that currently 
employed non-MSWs working as social workers do not lose their jobs. 
Some commenters said that experienced non-MSW social workers are 
competent and have a lot to offer, and they recommended that we 
continue the grandfather clause.
    Response: In general, we agree with commenters who stated that a 
social worker with an MSW degree is the best qualified individual to 
evaluate and assess transplant candidates, recipients, families, and 
living donors who are facing multiple psychosocial stressors. However, 
we also agree with commenters who said that non-MSW social workers who 
were employed as such prior to September 1, 1976 have much to offer 
patients and families. We also believe that there should be one 
standard for all transplant centers.
    To reconcile the conflicting viewpoints of commenters opposed to 
non-MSW social workers providing social services in transplant centers 
and commenters who urged us to retain the grandfather clause in the 
ESRD final rule, we have finalized the requirements for an individual 
to be a qualified social worker in any transplant center (not just a 
kidney transplant center) as follows. This final rule states that a 
qualified social worker is an individual who meets licensing 
requirements in the State in which he or she practices and: (1) Has 
completed a course of study with specialization in clinical practice 
and holds a masters degree from a graduate school of social work 
accredited by the Council on Social Work Education; or (2) is working 
as a social worker in a transplant center as of the effective date of 
this final rule and has served for at least 2 years as a social worker, 
1 year of which was in a transplantation program, and has established a 
consultative relationship with a social worker who is qualified under 
Sec.  482.94(d)(1).
    This grandfather clause applies only to individuals who are 
currently employed as social workers in a transplant center as of the 
effective date of this final rule. Although we believe the number of 
these individuals to be small, we do not intend that these employees 
should lose their jobs because of the deletion of the ``grandfather 
clause.''
    Comment: A commenter suggested that we adopt the OPTN policies for 
the psychosocial services that transplant centers should offer without 
defining the required qualifications for a social worker.
    Response: We do not agree that adopting OPTN policies without 
establishing requirements for social worker qualifications would serve 
the best interests of patients and living donors. As commenters 
overwhelmingly agreed, master's degree-prepared social workers are best 
qualified to provide

[[Page 15232]]

social services to transplant candidates and recipients, as well as 
living donors. Social workers often perform psychosocial evaluations of 
prospective transplant candidates and prospective living donors, and 
social workers provide critical services to transplant recipients and 
living donors during the inpatient and discharge phases of donation and 
transplantation. For example, prior to discharge, social workers 
provide counseling services to transplant recipients to assist them in 
maintaining the resolve they need to remain compliant with their 
immunosuppressive and other medications, which are necessary to prevent 
graft failure. We made no changes based on this comment.
    Comment: A commenter recommended that a qualified social worker 
should have training in, and knowledge of, pediatric transplant issues.
    Response: We agree that qualified social workers should have 
transplant training and knowledge of pediatric transplant issues, which 
can be achieved through on-the-job training or continuing education, if 
they are providing services in a pediatric center. We expect transplant 
centers to ensure that qualified social workers working in pediatric 
transplant programs receive ongoing staff development training to 
better handle issues that are unique to pediatric transplantation. We 
made no changes based on this comment.
    Comment: Some commenters supported the requirement for transplant 
centers to have nutritional assessments and diet counseling services 
furnished by a qualified dietitian available to all transplant patients 
and living donors. One commenter stated that medical nutrition therapy 
is important for patients and living donors. However, some commenters 
stated that transplant centers should not be responsible for transplant 
candidates' pre-transplant nutritional care or care during the 
evaluation phase for transplant, which is usually provided by 
candidates' local providers. A few commenters stated that transplant 
centers should not be required to provide ongoing post-transplant 
nutritional services to patients and living donors. The commenters 
requested clarification of the time frame for nutritional services 
provided to post-transplant patients, and stated that Medicare should 
reimburse for such services.
    Response: We agree that pre- and post-transplant nutritional care 
is usually provided by transplant patients' and living donors' local 
health care providers. This final rule requires transplant centers to 
provide nutrition services to transplant recipients and living donors 
only during their inpatient stay. For example, a transplant recipient 
may need to be counseled on the modification of his or her dietary 
regimen after organ transplant or a living donor may need to be 
counseled for his or her temporary adjustment in nutritional intake 
after living organ donation. These services are part of the hospital 
inpatient services reimbursed by Medicare for beneficiaries and often 
for their living donors.
    Comment: Some commenters suggested that living donors, particularly 
living kidney donors, should be exempt from nutritional services since 
they are healthy individuals.
    Response: Although living donors are usually healthy individuals, 
we believe they should receive the same care provided to transplant 
recipients. Under the final rule and as proposed, transplant centers 
are responsible for making nutritional assessment and dietary 
counseling services furnished by a qualified dietitian available to all 
living donors while they are hospitalized for organ donation.
    Comment: A commenter suggested that we should adopt the OPTN policy 
for nutritional services without defining the qualifications for a 
qualified dietitian.
    Response: Currently, the OPTN does not have a policy for 
nutritional services furnished by transplant centers.
    Comment: One commenter suggested adopting the Medical Nutrition 
Therapy (MNT) regulation definition of ``qualified dietitian.'' A few 
commenters suggested that the definition of a qualified dietitian in 
the transplant center rule and the ESRD rule should be consistent.
    Response: We have not used the MNT definition for registered 
dietitian in this final rule because it includes both registered 
dietitians and other nutritional professionals, and we believe this may 
cause confusion. However, we have revised the proposed requirements at 
Sec.  482.94(e).
    In this final rule, we require that a qualified dietitian must be a 
registered dietitian with the Commission on Dietetic Registration 
(CDR), who meets the practice requirements in the State in which he or 
she is employed. (See Sec.  482.94(e).) For the most part, these 
requirements are similar to those included in the proposed rule for new 
conditions for coverage for ESRD facilities published February 4, 2005 
(70 FR 6184). To date, the ESRD facility final rule has not yet been 
published.

Condition of Participation: Quality Assessment and Performance 
Improvement (QAPI) (Proposed Sec.  482.96)

    We proposed that every transplant center must develop, implement, 
and maintain a written, comprehensive, data-driven QAPI program 
designed to monitor and evaluate the performance of all transplantation 
services, including services provided under contract or arrangement.
    We proposed requiring a transplant center's QAPI program to use 
objective measures to evaluate the center's performance with regard to 
transplant activities and outcomes. We proposed that these activities 
and outcomes may include, but would not be limited to, patient and 
donor selection criteria, accuracy of the waiting list in accordance 
with the OPTN waiting list, accuracy of donor-recipient matching, 
patient and donor management, techniques for organ recovery, consent 
practices, patient satisfaction, and patient rights. We proposed that 
the transplant center must take actions that result in performance 
improvements and track performance to ensure that improvements are 
sustained.
    We proposed that transplant centers must establish and implement 
written policies to address and document any adverse events that occur 
during any phase of an organ transplantation case. We proposed that a 
transplant center must have policies to address, at a minimum, the 
process for identification, reporting, analysis, and prevention of 
adverse events. We also proposed that a transplant center must conduct 
a thorough analysis of, and document, any adverse event and must 
utilize the analysis to effect changes in the transplant center's 
policies and practices to prevent repeat incidents. Following are 
summaries of the comments we received and our responses.
    Comment: Some commenters supported the proposed requirement for a 
transplant center to have a defined QAPI process. Commenters said the 
proposed objective measures and adverse events standards were 
reasonable and would provide impetus for transplant centers to 
scrutinize and improve performance. A commenter stated that QAPI 
programs should be quality-driven and not complaint-driven.
    Response: We appreciate the commenters' support of the proposed 
QAPI requirements. We anticipate that transplant centers will take 
advantage of their own transplant data as well as the wealth of 
transplant data available

[[Page 15233]]

through the OPTN and the SRTR and utilize them effectively to evaluate 
their own performance and effect positive changes.
    Comment: Some commenters stated that the proposed requirement for a 
transplant center to develop, implement, and maintain a QAPI program 
would not contribute to improving patient outcomes.
    Response: We disagree with the commenters. The effectiveness of 
QAPI programs in improving the delivery of health care is widely 
accepted throughout the health care community. An effective QAPI 
program uses objective data to study and make improvements to all 
patient care processes on a continuing basis. We expect transplant 
centers to focus on areas of sub-optimal performance and prioritize 
outcome measures for improvement. Using this approach, a transplant 
center can: (1) Identify areas where outcomes indicate a need for 
improvement; (2) define systematic changes needed to improve outcomes; 
(3) review implementation of improvement actions; and (4) determine the 
success of the actions to improve performance.
    Comment: Some commenters stated that the QAPI program of a JCAHO 
accredited hospital and the OPTN oversight of transplant centers should 
eliminate the need for a separate transplant center-based QAPI program. 
Some commenters were concerned about the extra resources needed for a 
transplant center to have a separate QAPI program. Commenters suggested 
using the OPTN and SRTR as surrogates for transplant centers' QAPI 
programs. Some commenters recommended that transplant centers should be 
given the choice of using the hospital QAPI program or establishing a 
transplant-center-based QAPI program. A few commenters suggested using 
a formal QAPI program as part of a remediation process for centers that 
failed to comply with outcome measures.
    Response: It is a common practice to use QAPI programs to improve 
the delivery of health care to patients. The intent of the QAPI 
requirement in this final rule is to develop a structured process for 
transplant centers to analyze and evaluate transplant patient outcomes 
data and transplant center processes continuously and effect changes 
accordingly. Hospitals have the flexibility to incorporate a transplant 
center's QAPI program into the hospital QAPI process. However, given 
the complexity and the uniqueness of some transplant issues, we 
disagree that a general hospital QAPI program or OPTN oversight alone 
could adequately substitute for a transplant center-based QAPI program. 
Further, we disagree that the OPTN and the SRTR should serve as 
surrogates for transplant centers' QAPI programs. Every transplant 
center should tailor its QAPI program to meet its needs and its patient 
population to better serve the best interests of its patients.
    Comment: A commenter recommended expanding the components of the 
QAPI program to include adverse events, electronic prescribing, 
clinical decision support, bar coding, and provider and patient 
education.
    Response: We thank the commenter for the suggestions. We agree that 
it is appropriate to include patient education as part of the QAPI 
components, and we have included this requirement in the regulation 
text at Sec.  482.96(a) in this final rule.
    As we proposed, this final rule includes a separate QAPI standard 
at Sec.  486.92(b) that requires transplant centers to establish and 
implement written policies to address and document adverse events. 
Therefore, we do not believe it is necessary to list adverse events as 
one of the specific components of a QAPI program at Sec.  482.96(a).
    We believe the other components suggested by the commenter belong 
in the hospital's overall QAPI program because they affect patient care 
and other functions throughout the organization. Therefore, no other 
changes have been made based on this comment.
    Comment: A few commenters supported the proposed standard for 
transplant centers to address transplant-related adverse events. A 
commenter noted that we should specify the frequency of internal and 
external audits of the adverse events reporting and analysis.
    Response: We expect transplant centers to analyze adverse events as 
they occur and to make systemic and other changes promptly, as 
necessary, based on their analysis. However, this final rule does not 
specify the frequency of internal audits or external audits of adverse 
events. The frequency of adverse events reporting and analysis should 
be contained in a transplant center's QAPI adverse events policies.
    Comment: Some commenters stated that JCAHO survey standards require 
hospitals to have QAPI policies and sentinel events reporting and 
investigation. The commenters were concerned that the proposed adverse 
event standard is redundant and resource-intensive.
    Response: As stated earlier, to reduce redundancy, a transplant-
oriented QAPI program can be integrated into a hospital's QAPI program 
for accreditation purposes. Therefore, we do not believe the adverse 
events requirement, which is one of the QAPI standards in this final 
rule, will be excessively resource-intensive.
    Comment: A few commenters requested the exclusion of non-
transplantation-related end-stage organ disease in the adverse events 
definition.
    Response: We did not propose including non-transplantation-related 
end-stage organ disease in the definition of ``adverse events.'' The 
examples of adverse events provided in the definition of adverse events 
in both the proposed rule and this final rule relate only to donation 
by living donors and to transplantation.

Condition of Participation: Human Resources (Proposed Sec.  482.98)

    We proposed that transplant centers must ensure that all 
individuals who provide services and/or supervise services at the 
center, including individuals furnishing services under contract or 
arrangement, are qualified to provide or supervise such services.
    We proposed that each transplant center must be under the general 
supervision of a qualified transplant surgeon or a qualified physician-
director with designated responsibilities. We proposed that the 
director of a transplant center need not serve full-time and may also 
serve as a center's primary transplant surgeon or transplant physician 
in accordance with Sec.  482.98(b).
    We proposed that the director would be responsible for planning, 
organizing, conducting and directing the transplant center and must 
devote sufficient time to carrying out these responsibilities, which 
include, but are not limited to, ensuring:
    (1) Adequate training of nursing staff in the care of transplant 
patients;
    (2) That tissue typing and organ procurement services are 
available;
    (3) That transplantation surgery is performed under the direct 
supervision of a qualified transplant surgeon in accordance with Sec.  
482.98(b).
    We proposed that transplant centers must identify to the OPTN both 
a primary transplant surgeon and a primary transplant physician with 
the appropriate training and experience to provide transplantation 
services. We proposed that the transplant surgeon is responsible for 
providing surgical services related to transplantation, and the 
transplant physician is responsible

[[Page 15234]]

for providing and coordinating transplantation care.
    We proposed that transplant centers must have a qualified clinical 
transplant coordinator to ensure the continuity of care of patients and 
living donors during the pre-transplant, transplant, and discharge 
phases of transplantation and the donor evaluation, donation, and 
discharge phases of donation. We proposed requiring that a qualified 
clinical transplant coordinator must be certified by the American Board 
of Transplant Coordinators (ABTC).
    We proposed that a transplant center must identify a 
multidisciplinary transplant team and describe the responsibilities of 
each member of the team. We also proposed that the team must be 
composed of individuals with the appropriate qualifications, training, 
and experience in the relevant areas of medicine, nursing, nutrition, 
social services, transplant coordination, and pharmacology.
    We proposed that a transplant center must demonstrate the 
availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, and blood banking as related to the provision of 
transplantation services. Following are summaries of the comments we 
received and our responses.
    Comment: Although some commenters supported the proposal that 
transplant centers must ensure that all individuals providing 
transplant services are qualified, one commenter stated that transplant 
centers should have the flexibility to determine their own personnel 
needs. The commenter voiced concern that the cost of meeting the 
proposed staffing requirements would increase costs to such an extent 
that facilities would no longer be able to contract with managed care 
companies because managed care reimbursement would be insufficient to 
cover costs.
    Response: We believe the staffing requirements in this final rule 
are critical for the protection of the health and safety of living 
donors and transplant recipients. Based on public comments, we have 
eliminated our proposed requirement for ABTC certification for clinical 
transplant coordinators, and we have added a requirement in this final 
rule for a living donor advocate or advocate team, which may increase 
overhead costs for some transplant centers. However, as we discuss in 
more detail in the Impact Analysis Section of this preamble, we do not 
expect the donor advocate or donor advocate team requirement in this 
final rule to increase costs substantially. In fact, we expect an 
average increase of less than $18,500 per transplant center annually.
    Comment: Some commenters stated that the OPTN policies for 
transplant personnel are industry gold standards and that they should 
be adopted by us and monitored by the OPTN. One commenter stated that 
the OPTN and CMS human resources requirements should be consistent.
    Response: We believe our requirements are consistent with OPTN 
policies and bylaws. Section 482.72 of this final rule requires 
transplant centers to be OPTN members. While the final rule governing 
the operation of the OPTN does not require transplant programs within 
OPTN member hospitals that receive their designation by virtue of their 
Medicare approval to meet the OPTN's on-site primary transplant surgeon 
and transplant physician requirements, such programs are reviewed by 
the OPTN, on a voluntary basis, for compliance with such requirements. 
We expect that transplant centers, as members of the OPTN, will have no 
difficulty meeting these regulatory requirements, as the OPTN 
requirements are more extensive than our requirements.
    Comment: One commenter suggested that we should add a ``grandfather 
clause'' for transplant staff to Sec.  482.98, Human resources, as a 
transition to the new human resources requirements. That is, transplant 
centers should be permitted to continue to employ their current staff, 
even if some staff do not meet specific education, training, or 
licensure requirements in the final rule.
    Response: As we stated in our previous response, we expect that 
transplant centers who are OPTN members will have no difficulty meeting 
our requirements. Our requirements for transplant surgeons and 
physicians are congruent with OPTN requirements. Furthermore, we have 
eliminated the proposed requirement for ABTC certification for 
transplant coordinators based on public comments, and we replaced it 
with a requirement for a clinical transplant coordinator to be an RN or 
clinician licensed in the State in which the coordinator practices and 
to have specific job-related skills. We expect that all or nearly all 
currently-employed clinical transplant coordinators already have these 
qualifications. We are requiring a donor advocate or donor advocate 
team to have certain knowledge and abilities but not specialized 
education or training.
    Comment: A commenter recommended that we require transplant centers 
to have a transplant pharmacist on the transplant team.
    Response: Section 482.98(e) of this final rule states that the 
multidisciplinary transplant team must be composed of individuals with 
the appropriate qualifications, training, and experience in the 
relevant areas of medicine, nursing, nutrition, social services, 
transplant coordination, and pharmacology. Therefore, we expect that 
the team will include an individual with expertise in transplant 
pharmacotherapy. We have not made any changes in this final rule based 
on this comment.

Director of a Transplant Center

    Comment: Some commenters supported the proposal that a transplant 
center be under the general supervision of a qualified transplant 
surgeon or a qualified transplant physician director. However, one 
commenter suggested that we clarify the requirements for a qualified 
director of a transplant center. The commenter suggested that we permit 
a surgeon or a physician who meets the OPTN requirements for a 
designated surgeon or physician to be a transplant center director. 
Other commenters suggested that we cross-reference the OPTN definition 
for transplant surgeon or transplant physician qualification in the 
final rule. Some commenters recommended that we require the qualified 
transplant center director to be a certified surgeon or physician who 
has completed an approved American Society of Transplant Surgeons 
(ASTS) training/fellowship and who has been certified for all 
transplant programs.
    Response: We did not define the qualifications for a transplant 
center director, so that transplant centers will have the flexibility 
to recruit an OPTN-qualified transplant surgeon or physician for the 
position. The ASTS training/fellowship is one of the options for 
transplant surgeons to meet the OPTN training program requirement. 
However, there are other options surgeons can choose to meet the OPTN 
training requirement. We do not believe it is necessary to require 
transplant surgeons to participate in a specific organization's 
training program to be qualified to provide transplantation services in 
a Medicare-approved transplant center.
    As we have stated in some of our previous responses, we are not 
incorporating OPTN policies and bylaws into regulations by cross 
reference because we would be required to go through notice and comment 
rulemaking every time the policies and bylaws changed. OPTN policies 
for transplant surgeons and physicians are very detailed and subject to 
frequent

[[Page 15235]]

changes. We believe that such changes will occur too often for us to 
incorporate them expeditiously into our regulations. We will provide 
guidance regarding the definitions of qualified transplant center 
directors, surgeons, and transplant physicians in the Interpretive 
Guidelines. However, we can assure transplant centers that transplant 
surgeons and physicians who meet current OPTN requirements will meet 
the requirements in this final rule.
    Comment: One commenter pointed out that nurses do not routinely 
report to physicians in hospital settings. The commenter suggested that 
instead of holding the director of a transplant center responsible for 
ensuring adequate training of nursing staff in the care of transplant 
patients, we should require the hospital in which the transplant center 
is located to be responsible for the training of nursing staff.
    Response: The commenter was correct in stating that nursing staff 
do not usually report to physicians in a hospital setting. Therefore, 
we have modified our proposed language at Sec.  482.98(a)(1) in this 
final rule, to state that the director of a transplant center must 
collaborate with the transplant hospital in which the transplant center 
is located to ensure adequate training of nursing staff and clinical 
transplant coordinators in the care of transplant patients and living 
donors.

Transplant Surgeon and Physician

    Comment: Some commenters recommended grandfathering all currently 
active transplant surgeons who have not completed an ASTS fellowship. 
They also recommended that we require an ASTS fellowship for all new 
transplant surgeons.
    Response: Given that the OPTN gives transplant surgeons different 
options toward meeting the OPTN qualification requirements, we do not 
believe a grandfather clause is advisable. As stated previously, the 
ASTS training/fellowship is just one of the options for transplant 
surgeons to fulfill the OPTN training program requirements. Requiring 
all new transplant surgeons to complete an ASTS fellowship would be far 
too prescriptive and would be inconsistent with the OPTN bylaws.

Availability of Primary Transplant Surgeon and Physician

    We received many comments urging us to conform our requirements to 
the OPTN policies and bylaws for transplant surgeons and physicians, 
and we believe that we should be consistent with the OPTN rules in this 
regard. Under OPTN bylaws, a transplant center designated under 42 CFR 
121.9(a)(2) must have a primary transplant surgeon and a primary 
transplant physician onsite at all times. The immediate availability of 
a transplant surgeon is imperative to minimize time on the waiting list 
and mortality of transplant candidates. Recently, our surveyors 
discovered that the inability of a liver transplant center in 
California to retain a full-time transplant surgeon was a contributing 
factor to the center's high organ refusal rate, low numbers of 
transplants, and prolonged waiting time for transplant candidates.
    Therefore, under the final rule, we require not only that a 
transplant center must identify to the OPTN a primary transplant 
surgeon and a transplant physician with the appropriate training and 
experience to provide transplantation services as proposed at Sec.  
482.98(b), but also that these individuals are immediately available to 
provide transplantation services when an organ is offered for 
transplantation. By ``immediately available,'' we mean that the 
transplant surgeon and transplant physician must be available to 
provide transplantation services within a time frame that ensures there 
is no compromise to the viability of the organ or the health of the 
organ transplant recipient.

Clinical Transplant Coordinator

    Comment: Most commenters supported the proposed requirement for a 
transplant center to have a clinical transplant coordinator.
    Response: Clinical transplant coordinators are important links for 
transplant patients and living donors to transplant centers and 
dialysis facilities. We believe that clinical transplant coordinators 
are essential in coordinating the continuity of care of patients and 
living donors. They provide guidance to transplant recipients during 
the pre-transplant, transplant, and post-transplant phases and to 
living donors during the pre-donation, donation and post-donation 
phases.
    Comment: Many commenters supported the proposed requirement for 
American Board of Transplant Coordinators (ABTC) certification for a 
qualified clinical transplant coordinator and stated that the ABTC 
certification would minimize medical errors associated with donation 
and transplantation. A commenter stated that the ABTC certification is 
the ``gold standard''.
    However, many commenters strongly objected to our proposed 
requirement for ABTC certification. The commenters said that a 
requirement for ABTC certification would be arbitrary, given that there 
are other agencies that certify coordinators. Many transplant center 
commenters attested that their clinical transplant coordinators are 
Advance Practice Nurses, have received in-house training, have received 
continuing education training, or are ABTC-qualified but not ABTC 
certified, yet they perform their responsibilities well and provide 
excellent patient care. The commenters suggested accepting sub-
specialty certifications, such as critical care or case management, to 
qualify clinical transplant coordinators.
    Some commenters stated that the ABTC requirement would create 
recruitment hardship, especially for pediatric centers, and eventually 
raise overhead expenses for transplant centers. A few commenters 
requested an extension for pediatric centers to meet the ABTC 
requirement. The commenters noted that pediatric transplant programs 
usually hire Pediatric Advanced Practice Nurses who then acquire 
pediatric transplant experience through on-the-job training. Some 
commenters estimated that it takes about 18 months for a clinical 
transplant coordinator to become ABTC certified. To ease the difficulty 
of recruiting ABTC certified transplant coordinators, especially 
pediatric clinical transplant coordinators, some commenters suggested 
that we should allow 2 years for a newly-hired transplant coordinator 
to obtain ABTC certification while he or she continues to work under 
the supervision of an ABTC-certified coordinator. One commenter 
suggested requiring ABTC certification for non-RN clinical transplant 
coordinators while allowing RNs to be certified by credentialing bodies 
other than the ABTC. Some commenters recommended grandfathering all 
clinical transplant coordinators with at least 5 years of work 
experience.
    Some commenters did not believe that ABTC certification would 
improve the care of transplant patients. Other commenters suggested 
requiring the transplant director to be responsible for ensuring that 
clinical transplant coordinators receive adequate education and 
training. Several commenters recommended eliminating the ABTC 
certification requirement in the final rule.
    Response: Since the publication of the proposed rule, we have 
further examined the education, training, and experience of individuals 
who serve as clinical transplant coordinators. Although the ABTC 
certification examination is a valuable avenue to demonstrate 
transplant knowledge and skill, we found that many clinical transplant 
coordinators are RNs, clinical

[[Page 15236]]

nurse specialists, and nurse practitioners who have acquired transplant 
knowledge and practice experience in a variety of roles and settings. 
In recent decades, alternative health care practice models have 
provided the opportunity for nurses and clinicians to take on an 
expanded role in transplantation. Therefore, we have concluded that 
commenters were correct that there is more than one way to acquire the 
necessary knowledge and skill to be a clinical transplant coordinator. 
Furthermore, we agree with the commenters that limiting certification 
to a single organization is not appropriate. Therefore, we have not 
included a requirement for ABTC certification for transplant 
coordinators, as we proposed at Sec.  482.98(c).
    However, we believe that clinical transplant coordinators should be 
registered nurses or have clinical experience, and we note that OPTN 
policies require the clinical transplant coordinator to be either a 
registered nurse or other licensed clinician. Therefore, in this final 
rule, we have added a requirement that the clinical transplant 
coordinator must be either a registered nurse or a clinician licensed 
by the State in which the clinical transplant coordinator practices, 
who has experience in and knowledge of, transplantation and living 
donation issues. (See Sec.  482.98(c).) In addition, this final rule 
requires that the director of the transplant center must ensure that 
clinical transplant coordinators have adequate training in the care of 
transplant patients and living donors. (See Sec.  482.98(a)(1).) Also, 
we have added language that describes the responsibilities of the 
clinical transplant coordinator, which include, but are not limited to: 
(1) Ensuring the coordination of the clinical aspects of transplant 
patient and living donor care; and (2) acting as a liaison between a 
kidney transplant center and dialysis facilities, where applicable. 
(See Sec.  482.98(c).)
    Comment: Some commenters asked how many ABTC-certified coordinators 
are required, that is, whether one coordinator per transplant hospital 
or organ-specific transplant center is sufficient or whether all 
coordinators would need to be ABTC certified. A commenter suggested 
requiring only one ABTC-certified coordinator on site to provide 
overall supervision to other non-ABTC certified coordinators. A 
commenter recommended requiring a transplant center to have either an 
ABTC-certified clinical transplant coordinator or a State-licensed 
nurse with proficiency in complex professional and administrative 
transplant skills.
    Response: Although this final rule does not require ABTC 
certification, each organ-specific transplant center must have at least 
one clinical transplant coordinator who meets the requirements at Sec.  
482.98(c) of this final rule. Small transplant centers may share one 
clinical transplant coordinator.

Donor Advocate or Donor Advocate Team

    Comment: The majority of commenters supported our proposed 
requirement for an independent living donor advocate or a 
multidisciplinary advocate team. The commenters stated that a living 
donor advocate or multidisciplinary advocate team can ensure continuity 
of care of living donors during the pre-donation, donation and post-
donation phases.
    Only one commenter said that the services of a donor advocate or 
donor advocate team would not add value to the process of living 
donation. A few commenters stated that the requirement for a living 
donor advocacy team would cause hardship for small transplant programs.
    Response: We agree with the commenters who said that this 
requirement will serve the best interests of living donors. We expect 
that donor advocates and donor advocate teams will educate potential 
living donors about living donation, ensure that living donors have 
comprehensive medical and psychosocial evaluations, and make 
recommendations to the transplant team regarding prospective donors' 
suitability for donation. The presence of either a living donor 
advocate or an advocate team will encourage accountability for the 
protection of living donors' health and safety and ensure that 
principles of medical ethics and informed consent standards are applied 
to the practice of living donation.
    Under this final rule at Sec.  482.98, we state that a transplant 
center may choose to have either a living donor advocate or a donor 
advocate team. These individuals may be in-house hospital staff members 
who perform other duties in addition to their living donor advocate 
responsibilities. We believe this flexible approach will minimize the 
burden of providing donor advocacy services.
    Comment: Some commenters stated that transplant centers should be 
given the flexibility to define their own policies for a living donor 
advocate program. A few commenters stated that it is unnecessary to 
require a transplant center to designate a living donor advocate or an 
advocate team as long as there is an independent process to assess a 
living donor's risks and the benefits of donation. One commenter 
suggested that transplant centers should be required only to offer the 
consulting services of an in-house transplant-educated health care 
worker not directly involved in transplant procedures.
    Response: This final rule provides transplant centers with great 
flexibility in providing either a living donor advocate or donor 
advocate team. We do not specify requirements for a donor advocate's 
background, education, or training or the donor advocate team's 
composition. Instead, we specify their duties and the skills they must 
be able to demonstrate, specifically: (1) Knowledge of living organ 
donation, transplantation, medical ethics, and informed consent; and 
(2) understanding of the potential impact of family and other external 
pressures on the prospective living donor's decision whether to donate 
and the ability to discuss these issues with the donor. The independent 
living donor advocate or living donor advocate team is responsible for: 
(1) Representing and advising the donor; (2) protecting and promoting 
the interests of the donor; and (3) respecting the donor's decision and 
ensuring that the donor's decision is informed and free from coercion. 
A transplant center must identify either an independent living donor 
advocate or an independent living donor advocate team to ensure 
protection of the rights of living donors and prospective living 
donors. The living donor advocate or living donor advocate team must 
not be involved in transplantation activities on a routine basis.
    Comment: Many commenters suggested that the donor advocate team 
should include a qualified social worker as described in the proposed 
rule or a medical social worker (a social worker working in a medical 
setting). One commenter suggested that a multidisciplinary advocate 
team should include an internal medicine physician, a transplant 
coordinator/nurse clinician, a licensed social worker with a master's 
degree, a psychiatrist, and an ethicist. Some commenters suggested that 
either the living donor advocate or advocate team members should be 
educated in organ transplants.
    Response: We appreciate the commenters' suggestions for the 
composition of the multidisciplinary donor advocate team, and we agree 
that all the named professionals would be an asset to a donor advocate 
team. Transplant centers that choose to have a multidisciplinary donor 
advocate team may want to consider these suggestions in selecting 
appropriate team members to meet their needs. However, we believe it 
would be unnecessarily

[[Page 15237]]

prescriptive to require that donor advocate teams be composed of 
individuals from specific professions.
    Comment: Many commenters stated that the living donor advocate or 
the advocate team should be independent from the transplant team. That 
is, transplant centers should use different physicians and social 
workers to work with transplant patients and living donors. A commenter 
stated that it is difficult for a hospital-employed living donor 
advocate to stay independent.
    Response: We agree that the living donor advocate or donor advocate 
team should function independently from the transplant team to avoid 
conflicts of interest. Therefore, as stated earlier, this final rule at 
Sec.  482.98 (d)(1) requires that the living donor advocate or living 
donor advocate team not be involved routinely in transplantation.
    Comment: A commenter suggested that we designate the United Network 
for Organ Sharing (UNOS) as the gatekeeper for living donor rights and 
establish an Ombudsman as a resource for all donors nationwide.
    Response: UNOS functions as a contractor for the OPTN to collect 
and track all transplant data, including living donor transplants. CMS 
does not have the authority to designate UNOS as the gatekeeper for 
living donor rights. Such suggestions should be referred to UNOS and 
HRSA. The suggestion that we establish an Ombudsman as a resource for 
all donors nationwide falls outside the purview of this regulation. 
Therefore, no changes have been made based on this comment.

Multidisciplinary Transplant Team and Resource Commitment

    Comment: A few commenters stated that the OPTN policies already 
stipulate personnel requirements for transplant centers and that our 
proposed requirements either duplicated or were inconsistent with OPTN 
policies.
    Response: We proposed that a transplant center must identify a 
multidisciplinary transplant team and describe the responsibilities of 
each member of the team. The team must be composed of individuals with 
the appropriate qualifications, training, and experience in the 
relevant areas of medicine, nursing, nutrition, social services, 
transplant coordination, and pharmacology. The OPTN has personnel 
requirements for certain personnel, such as a clinical transplant 
coordinator, transplant pharmacist, and financial coordinator. However, 
the OPTN does not have the transplant team requirements that we 
proposed and that we have finalized in this rule.
    Comment: Many commenters suggested changing the term ``social 
services'' to ``social work'' (because there is ambiguity about who 
provides such services), and the term ``pharmacology'' to 
``pharmacist'' because not all centers have pharmacologists but all 
centers have pharmacists.
    Response: This final rule requires transplant centers to employ 
individuals with expertise in different relevant areas. We do not 
believe the terms ``social services'' or ``pharmacology'' need to be 
changed or clarified because this standard addresses the expertise of 
the individual transplant team members, and not the profession of these 
individuals. We made no changes based on this comment.
    Comment: A commenter recommended changing ``immunology'' to 
``immunology and immunosuppression management''.
    Response: One facet of immunology as a science is the study of 
organ transplantation and immunosuppression. We expect that to comply 
with the requirement in this final rule to demonstrate resource 
commitment in immunology, a transplant center will demonstrate resource 
commitment and availability of expertise in both immunology and 
immunosuppression. We have made no changes based on this comment.
    Comment: A commenter requested that we require pediatric transplant 
centers to demonstrate availability of expertise in ``pediatric 
medicine, pediatric surgery, pediatric urology, pediatric nursing, 
pediatric dialysis and pediatric intensive care.''
    Response: To be in compliance with the requirements in this final 
rule, a transplant center must provide services appropriate to its 
patient population. For example, Sec.  482.98(e) requires a transplant 
center to identify a multidisciplinary transplant team composed of 
individuals with the appropriate qualifications, training, and 
experience in the relevant areas of medicine, nursing, nutrition, 
social services, transplant coordination, and pharmacology. This means 
that the individuals who are part of a transplant team at a pediatric 
transplant center must have the qualifications, training, and 
experience to provide transplantation services to pediatric patients. 
Section 482.98(f) requires a transplant center to demonstrate 
availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, blood banking, and patient education as related to the 
provision of transplantation services. To meet this requirement, a 
pediatric transplant center must ensure that the expertise is 
commensurate with the needs of pediatric patients. Furthermore, the 
Department's OPTN regulations at 42 CFR 121.9 require transplant 
programs in OPTN member hospitals designated under OPTN criteria in 
Sec.  121.9(a)(2)(v) to show evidence of collaborative involvement with 
experts in the fields of, among other disciplines, pediatrics as 
appropriate.
    Comment: One commenter anticipated the rule will increase demand 
for nursing staff and suggested that we should recognize that Advanced 
Practice Registered Nurses (APRN) can play a role in transplant patient 
care.
    Response: We agree with the commenter that APRNs play an important 
role in health care. Transplant centers certainly have the discretion 
to recruit APRNs for their transplant teams as they believe necessary.
    Comment: One commenter said that the proposed resource commitment 
requirements would enhance patient's self-care management and positive 
patient outcomes. The commenter suggested that we add patient 
education.
    Response: We agree that patient education enhances patient's self-
care management and positive patient outcomes. In fact, most transplant 
centers provide ongoing patient education, which is provided by the 
transplant center staff, including transplant surgeons, physicians, 
nurses, transplant coordinators, dietitians, pharmacists, and social 
workers. We have adopted the comment to include patient education in 
this final rule as a required resource commitment for transplant 
centers at Sec.  482.98(f).

Condition of Participation: Organ Procurement (Proposed Sec.  482.100)

    We proposed requiring transplant centers to ensure that the 
hospital in which the center operates has a written agreement for the 
receipt of organs with an OPO designated by the Secretary.
    We proposed that the transplant center would be required to ensure 
that the transplant hospital's agreement with the OPO identifies 
specific responsibilities for the hospital and for the OPO with respect 
to organ recovery and organ allocation.
    We proposed that the transplant center must notify us in writing no 
later than 30 days after the termination of any agreement between the 
hospital and the OPO. Following is a summary of the comments we 
received on our proposed

[[Page 15238]]

provisions and our responses to the comments.
    Comment: A commenter stated that the proposed organ procurement 
provision is duplicative of 42 CFR 121.9(a)(2)(i).
    Response: The commenter was correct in identifying similarities 
between this provision and the designated transplant program 
requirements in the Department's regulations for the OPTN at 42 CFR 
121.9(a)(2)(i). Including the organ procurement requirements in this 
final rule provides us with oversight and enforcement authority and 
imposes the requirements on transplant programs that received their 
designation by virtue of their approval for reimbursement for Medicare.
    Comment: A few commenters suggested requiring a center to notify 
the OPTN if its hospital's agreement with an OPO has been terminated.
    Response: We do not believe terminating an agreement with an OPO is 
a step a hospital would take without the knowledge of the OPTN. Thus, 
we do not believe it is necessary for us to require a transplant center 
to notify the OPTN if the hospital in which it is located terminates 
its agreement with an OPO. We have made no change in this final rule 
based on this comment.
    Note that for the sake of consistency and to facilitate transplant 
centers' use of the regulations, we have moved the requirement to 
notify us if the hospital in which a transplant center is located 
terminates its agreement with an OPO for organ recovery and receipt 
from Sec.  482.100 to Sec.  482.74(a)(3), Notification to CMS. This 
change locates all events that must be reported to us within the same 
condition of participation and results in consistent time frames for 
notification. The requirement for notifying us if the hospital in which 
a transplant center is located terminates its agreement with an OPO for 
organ recovery and receipt is changed from 30 days to ``immediately,'' 
to facilitate monitoring of waiting list patients' access to organs.

Condition of Participation: Patient and Living Donor Rights (Proposed 
Sec.  482.102)

    In our discussion of patient rights in the preamble to the proposed 
rule, we said that we believed a living donor advocate or advocate team 
would ensure that the informed consent standards meet ethical 
principles as applied to the practice of living donor organ 
transplantation. Thus, we requested comments on whether we should 
include a requirement in the final rule for transplant centers 
performing living donor transplants to provide the services of an 
independent living donor advocate or advocate team, as well as 
recommendations for individual or team credentials. Based on public 
comments, we have added a requirement in this final rule, at Sec.  
482.98(d) CoP: Human resources, for an independent living donor 
advocate or living donor advocate team. The preamble discussion of an 
independent living donor advocate or living donor advocate team is 
located under the Human resources section of this final rule.
    We proposed that in addition to meeting the general hospital 
requirements for patients' rights in the hospital CoPs at Sec.  482.13, 
a transplant center must protect and promote each transplant patient's 
and living donor's rights.
    We proposed that the transplant center must have a written informed 
transplant patient consent process that informs each patient of: (1) 
The evaluation process; (2) the surgical procedure; (3) alternative 
treatments; (4) potential medical and psychosocial risks; (5) national 
and transplant center-specific outcomes; (6) the fact that future 
health problems related to the transplantation may not be covered by 
the recipient's insurance and that the recipient's ability to obtain 
health, disability, or life insurance may be affected; (7) organ donor 
risk factors that could affect the success of the graft or the health 
of the patient, including, but not limited to, the donor's history, 
condition or age of the organs used or the patient's potential risk of 
contracting the human immunodeficiency virus and other infectious 
diseases if the disease cannot be detected in an infected donor; and 
(8) his or her right to refuse transplantation.
    We proposed that transplant centers must implement a written living 
donor informed consent process that informs prospective living donors 
of all aspects of living donation and potential outcomes from living 
donation. We proposed that transplant centers must ensure that 
prospective living donors are fully informed about the following: (1) 
The fact that communication between the donor and the transplant center 
will remain confidential in accordance with the requirements at 45 CFR 
parts 160 and 164; (2) the evaluation process; (3) the surgical 
procedure, including post-operative treatment; (4) availability of 
alternative treatments for the transplant recipient; (5) potential 
medical and psychosocial risks to the donor; (6) national and 
transplant center-specific outcomes for both donors and recipients; (7) 
the possibility that future health problems related to the donation may 
not be covered by the donor's insurance, and that the donor's ability 
to obtain health, disability, or life insurance may be affected; and(8) 
the donor's right to opt out of donation at any time during the 
donation process.
    We proposed that a transplant center must notify its waiting list 
patients of information about the center that could impact the 
patient's ability to receive a transplant should an organ become 
available, and the procedures that are in place to ensure the 
availability of a transplant team.
    We proposed that a transplant center served by a single transplant 
surgeon or physician would be required to inform its waiting list 
patients of the potential unavailability of the transplant surgeon or 
physician and whether the center had a mechanism to provide an 
alternate transplant surgeon or transplant physician that meets the 
hospital's credentialing policies.
    We proposed that at least 30 days before a center's Medicare 
approval was terminated, whether voluntarily or involuntarily, the 
center would have to inform the patients on the waiting list of this 
fact, and must provide assistance to patients who choose to transfer to 
another Medicare-approved center, without loss of the patient's time 
accrued on the waiting list.
    We also proposed that if a transplant center were terminated, such 
transplant center would have to inform Medicare beneficiaries on the 
center's waiting list that Medicare would no longer pay for transplants 
performed at the center after the effective date of the center's loss 
of approval.
    We requested comments on the proposed requirement for a transplant 
center to inform patients of potential organ donor risk factors that 
could affect the success of the graft or the health of the patient, 
including, but not limited to, the donor's history; condition or age of 
the organs used; or the patient's possible risk of contracting the 
human immunodeficiency virus and other infectious diseases if the 
disease could not be detected in an infected donor. We also solicited 
comments regarding our proposed informed consent requirements for 
living donors, including those requirements we proposed adopting from 
the Secretary's Advisory Committee on Transplantation (ACOT) 
recommendations, and whether we would need to establish additional 
criteria for transplant centers performing living donor transplants.
    Following are summaries of the comments we received and our 
responses.
    Comment: Some commenters said that all kidney transplant centers 
should be

[[Page 15239]]

exempt from initial approval requirements (such as the requirement to 
perform 9 transplants) because a lengthy initial approval process would 
delay access to the new kidney center's transplantation services for 
Medicare beneficiaries.
    Response: We share the commenters' concern that a lengthy approval 
process for kidney centers, particularly a requirement to perform 10 
transplants prior to approval, may disadvantage Medicare beneficiaries 
who need kidney transplants by limiting their access to transplantation 
services at new kidney transplant centers. Under section 1861(s)(2)(J) 
of the Act, almost all ESRD transplant candidates must have their 
transplant surgery and follow-up care provided by a center that is 
already Medicare-certified in order for their immunosuppressant drugs 
to be paid for under Part B of Medicare as part of the Medicare 
transplantation services. Therefore, we are concerned that some new 
kidney centers may offer to provide free kidney transplants to Medicare 
beneficiaries in order to meet the Medicare clinical experience 
requirements and thus obtain Medicare approval expeditiously. These 
prospective kidney transplant candidates may not be aware of the 
implications for such free transplants that Medicare only pays for 
prescription drugs used in immunosuppressive therapy under Medicare 
Part B if the transplant was performed in a Medicare-approved facility.
    Therefore, we have added a requirement under the CoP for Patient 
and Living Donor Rights at Sec. Sec.  482.102(a)(8) and 482.102(b)(9) 
that a transplant center must inform Medicare beneficiaries who are 
prospective transplant recipients and their living donors that 
receiving a transplant that is not provided in a Medicare-approved 
transplant center could affect the transplant recipient's ability to 
have his or her immunosuppressive drugs paid for under Medicare Part B. 
See further discussion of this requirement in this preamble under 
``Centers With Current Medicare Approval.''
    Comment: A commenter recommended that the OPTN incorporate ACOT 
recommendations on transplant patient and living donor rights into its 
policies and monitor transplant center compliance. Another commenter 
suggested that we or the OPTN should provide transplant centers with 
sample education materials to educate donors about their rights.
    Response: The OPTN has published a variety of transplant education 
brochures for centers to distribute to patients and living donors; the 
list of resources is available at www.transplantliving.org. Although 
the OPTN does not have any publications specific to living donation 
(with the exception of some limited information published in the 
booklet titled ``What Every Patient Needs to Know'') it has posted 
extensive living donation information on its Web site. Suggestions that 
the OPTN adopt ACOT recommendations are beyond the scope of this rule.

Informed Consent

    We are removing the proposed requirement that transplant centers 
inform transplant candidates of ``the fact that future health problems 
related to the transplantation may not be covered by the recipient's 
insurance, and that the recipient's ability to obtain health, 
disability, or life insurance may be affected.'' This language was 
included in the proposed rule in the standard for informed consent for 
transplant patients at Sec.  482.102(a)(6); similar language was 
included in the standard for informed consent for living donors at 
Sec.  482.102(b)(7). It was intended to apply only to living donors. 
Thus, it has been removed at Sec.  482.102(a)(6).
    Comment: Many commenters supported the requirement for informed 
consent to protect patient rights. However, some commenters supported 
the adoption of the ACOT recommendations in their entirety, rather than 
the limited number of specific informed consent elements that we 
proposed. One commenter recommended that we require a standardized 
informed consent process for all transplant centers.
    Response: We have chosen not to adopt the ACOT recommendations in 
their entirety because they are extensively detailed and go beyond what 
we perceive as necessary for Medicare approval. Instead, we have 
adopted the ACOT recommendations that are directly related to 
transplant patient and living donor rights. We have not included other 
recommendations that address organ donation, organ allocation, and 
organ procurement organizations. This final rule does not require a 
standardized informed consent process because such a requirement would 
deprive transplant centers of the flexibility we believe they need to 
develop informed consent policies that best serve their needs.
    Comment: A few commenters stated that the proposed informed consent 
provisions for transplant patients and living donors are too 
prescriptive and not a standard practice in medicine. The commenters 
said that a transplant center's only legal obligation is to provide 
patients and living donors with sufficient information to make an 
informed decision. A few commenters said that the requirement for a 
written informed consent process is burdensome and unnecessary since 
hospitals already have informed consent policies that may be applicable 
to transplants.
    Response: As a standard practice for any type of surgical 
procedure, a hospital has the obligation to provide patients with 
sufficient information to make informed decisions. We believe the 
elements of informed consent that we proposed and that we require under 
this final rule are the minimum necessary to ensure transplant patients 
and living donors can make an informed decision. (See Sec.  
482.102(a).) We believe this basic information should be provided to 
patients and living donors by all transplant centers.
    We recognize that a transplant center's informed consent process 
may overlap with the hospital's informed consent process. A transplant 
center may choose to integrate the required elements for the transplant 
center informed consent process into the hospital informed consent 
process. We note, however, that transplant patients and living donors 
are uniquely vulnerable patients. Prospective transplant recipients 
desperately need scarce, life-saving organs, and many of them will die 
waiting. Prospective living donors are healthy individuals who are 
contemplating undergoing surgery, at some risk to themselves, to 
provide a life-saving transplant to another individual. These patients 
and prospective living donors must absorb a great deal of information 
in order to provide a truly informed consent.
    In their recommendation, ACOT endorsed two ethical principles: (1) 
Equipoise; that is, the benefits to both the donor and the recipient 
outweigh the risks associated with the donation and transplantation of 
the live donor organ; and (2) that the potential donor's participation 
is completely voluntary and may be withdrawn at any time. We believe 
transplant centers should base their informed consent policies and 
procedures on these principles and implement them scrupulously. We made 
no changes based on these comments.
    Comment: A commenter stated that once a transplant center documents 
in medical records that a patient's informed consent was obtained 
(including the specifics that were discussed), it should be sufficient 
evidence that an informed consent policy exists.

[[Page 15240]]

    Response: We disagree. We expect a transplant center to have 
informed consent policies that include a written informed consent 
process and documentation that informed consent was given. Therefore, 
the documentation of informed consent alone would not be sufficient to 
substitute for a written informed consent policy.
    Comment: Some commenters suggested eliminating the prescriptive 
informed consent language. One commenter stated that the requirement 
for a transplant center to inform patients about the patient evaluation 
process is too prescriptive.
    Response: We believe the information in the elements of informed 
consent that we proposed and that are set forth in this final rule are 
necessary for patients to make an informed decision about 
transplantation. We also believe it is important for transplant 
candidates to understand how they will be evaluated for placement on 
the waiting list, how their readiness for transplant will be 
ascertained while they are awaiting transplantation (for example, 
through periodic blood tests), and what factors could require their 
removal from the waiting list.
    Comment: Some commenters said that a transplant center should be 
required to use a patient education checklist to educate patients about 
transplant risks. One commenter asked how patient informed consent 
should be documented to comply with this requirement.
    Response: A transplant center may use any patient education tools, 
such as a patient education checklist, to educate patients about 
transplant risks, as long as the center includes the required elements. 
A transplant center may choose to document the discussion of informed 
consent in any format as long as the discussion is documented in the 
patient's medical record.
    Comment: One commenter stated that a last-minute discussion of 
potential donor risk with a transplant recipient would be extremely 
difficult because the window of time between organ procurement and 
transplantation is very short. The commenter said that it is 
unrealistic to require centers to repeat the extensive informed consent 
process at the time of transplantation and suggested that the 
discussion with transplant candidates about potential risks should be 
done well before an actual organ offer takes place. The commenter 
recommended that the informed consent process be limited to the point 
in time when a patient is placed on a transplant waiting list.
    Response: We agree with the commenter. Our expectation is that 
discussion of potential donor risk factors should occur well before an 
organ is offered, for example, when the patient is first placed on the 
waiting list, and the information should be reviewed with the patient 
from time to time. We agree with the commenters that the time period 
between organ procurement and the offer of an organ may be too short 
for a thorough discussion of informed consent with patients. We do not 
expect a transplant center to rush through a detailed discussion of 
potential donor risk factors with transplant candidates just prior to 
transplantation.
    Comment: Some commenters expressed concern that it could be 
impossible for transplant centers to discuss all potential organ donor 
risk factors with transplant candidates. Another commenter stated that 
requiring a transplant center to provide a written explanation of 
organ-specific risk factors to patients would be burdensome.
    Response: Although it may not be possible for transplant centers to 
discuss every single potential organ donor risk factor with patients on 
their waiting lists, we expect centers to cover, at a minimum, the 
factors listed in the text of this final rule, that is, donor history; 
condition or age of the organs used; and the patient's risk of 
contracting the human immunodeficiency virus and other infectious 
diseases if the disease cannot be detected in an infected donor. 
Providing this information should ensure that patients understand 
before they make transplant decisions that certain factors may affect 
the success of their transplant. Transplant centers certainly have the 
flexibility to discuss other risk factors beyond those we have 
delineated in this final rule.
    The requirement for transplant centers to have a written informed 
consent process does not mean that centers must provide a written 
explanation of organ-specific risk factors to transplant patients. As 
proposed, this final rule requires only that a transplant center inform 
patients of organ and organ donor risk factors.
    Comment: A commenter recommended that we require transplant centers 
to provide some minimal information for patients contemplating 
acceptance of an extended criteria donor (ECD) kidney as follows: (1) 
The increased likelihood of delayed graft function; (2) decreased graft 
survival compared to a non-ECD kidney; (3) increased longevity compared 
to remaining on dialysis; (4) the potential for decreased waiting time 
for a donated kidney; and (5) the benefit of receiving a transplant 
prior to beginning dialysis, which may cause related morbidity and 
mortality.
    Response: We agree with the commenter that these factors should be 
discussed with patients contemplating acceptance of an ECD kidney. As 
discussed in our previous comment, the fact that transplantation of 
certain types of organs (such as ECD or DCD organs) may have an effect 
on patient or graft survival must be discussed with transplant 
candidates, as appropriate. Thus, if a kidney transplant center 
transplants organs from ECDs, they should include all relevant facts 
about ECD organs in their discussion of organ donor risk factors with 
patients who are candidates for transplantation with an ECD organ, 
especially information about patient morbidity and mortality on 
dialysis versus transplantation with an ECD organ.
    Comment: A commenter suggested letting the transplant surgeon 
decide based on OPTN guidelines whether the organ donor risk factors 
are significant enough to warrant a discussion with a patient.
    Response: We agree with the commenter that the transplant surgeon 
should be responsible for taking the lead in discussing potential organ 
donor risk factors with the patient. At a minimum, we expect the 
transplant surgeon to discuss the potential organ donor risk factors 
described at Sec.  482.102(a). The transplant surgeon also should 
decide whether other factors should be discussed. Although currently, 
there are no universal guidelines for organ donor risk factors, we 
believe surgeons should be able to reference current practices in their 
discussions with patients.
    Comment: Some commenters objected to the proposed requirement to 
inform patients of national and center-specific transplantation 
outcomes, as indicated in the SRTR reports. The commenters stated that 
expected survival rates indicated in the SRTR do not reflect the 
potential compromise of outcomes resulting from the use of ECD/DCD 
organs by some centers.
    In addition, the commenters were concerned that some patients may 
not have adequate knowledge to interpret the expected survival data 
properly.
    Response: The national and center-specific outcomes as indicated in 
the SRTR reports are already publicly available at http://www.ustransplant.org. The SRTR has added ECD as one of the risk-
adjustment factors used in calculating expected survival rates. The 
OPTN may consider including DCD organs as one of the risk-adjustment 
factors when more data are available.

[[Page 15241]]

    Some patients may not be able to fully comprehend the SRTR reports. 
Nonetheless, we expect a transplant center to provide guidance to 
patients and families in finding and interpreting the SRTR reports in 
relation to the center's own patient outcomes. At a minimum, we expect 
a transplant center to provide prospective transplant recipients, their 
families, and prospective living donors with information from the most 
recent SRTR center-specific report, including (but not limited to) the 
transplant center's observed and expected 1-year patient and graft 
survival, national 1-year patient and graft survival, and notification 
about all Medicare outcome requirements not being met by the transplant 
center.
    Comment: Many commenters supported establishing requirements for an 
informed consent process for living donors. Some commenters noted that 
informed consent for living donors protects the donor and reduces legal 
liability for the transplant team. Many commenters said that they 
specifically supported incorporating the ACOT recommendations into 
Medicare requirements. In fact, one commenter was concerned that we had 
not adopted all of ACOT's initial recommendations related to living 
donation.
    Response: We agree that protections for living donors are 
essential. Therefore, as proposed, we are adopting the ACOT 
recommendations that address the health and safety of living donors.
    Although we have not adopted the ACOT recommendations for living 
donors in this final rule in their entirety, because some of them fall 
outside the purview of this rule, we recommend that transplant centers 
that perform living donor transplants consider them when developing 
informed consent policies for living donors.
    Comment: A commenter stated that there is no compelling reason why 
the proposed informed consent process for living donors should go 
beyond the OPTN requirements.
    Response: Currently, the OPTN Living Donor Committee workgroup has 
identified living donor safety promotion as a major focus of the OPTN. 
However, standardized OPTN informed consent language for living donors 
has yet to be developed. In light of the fact that living donation is 
becoming more common, there is an increasing need to protect the health 
and safety of living donors. Further, as we have stated in our 
responses to previous comments including these requirements in 
regulations provides us with the authority for oversight and 
enforcement.
    Comment: A commenter stated that the requirement for transplant 
centers to model the ACOT recommendations for informed consent for 
living liver donors is overbearing and noted that it should not apply 
to living kidney donors as living kidney donation is a more simplified 
procedure requiring fewer informed consent details.
    Response: We did not propose requiring hospitals to adopt the ACOT 
recommendations for informed consent for living liver or kidney donors. 
We cited the documents in the preamble to the proposed rule only to 
provide guidance for transplant centers developing informed consent 
polices for living donors. However, all living donors deserve the same 
level of protection. Although individuals contemplating living donation 
of different organ types may need different information, all living 
donors should be provided with sufficient information on which to make 
a fully informed decision.
    Comment: A commenter requested clarification on the requirement for 
documentation of informed consent for living donors, and the commenter 
asked if separate informed consent forms are needed for living donors.
    Response: A transplant center may choose to document the discussion 
of informed consent with living donors in any manner it chooses. The 
center may document every discussion in detail or use a checklist or 
any other tool of its choice to indicate that all the core components 
were covered. We expect that transplant centers will use different 
informed consent forms for living donors since the informed consent 
components are slightly different than for transplant recipients.
    Comment: A commenter noted that the presentation of the elements of 
informed consent to potential recipients and living donors should be 
easy to understand and consistent with each patient's native language 
and educational level. The commenter said that adequate time should be 
given to donors to make a donation decision that is free from coercion 
and noted that New York State law gives living donors 2 weeks to make a 
decision.
    Response: We agree with the commenter's observations. Nevertheless, 
we have not specified requirements in this final rule for educational 
level or language for informed consent documents, nor have we specified 
a standard period of time prospective living donors be given to make a 
donation decision. We have avoided such prescriptive requirements 
throughout this final rule to provide transplant centers with the 
maximum flexibility to implement the rule's requirements according to 
their needs and the needs of their patient populations. Although we 
have not incorporated the commenter's suggestions into this final rule, 
we would urge transplant centers to consider the suggestions as they 
develop their informed consent process.
    Comment: Some commenters supported the concept of informing living 
donors of short and long-term risks but suggested eliminating the 
requirement because providing this information would require the 
availability of a living donor registry that tracks these risks. A 
commenter recommended that the Secretary pursue action to establish a 
living donor registry.
    Response: Currently, there is no official living donor registry. 
However, collection of living donor outcome metrics by the OPTN is 
ongoing, and the follow-up data period for live donors has been 
extended from 1 year to 2 years post-transplant. The OPTN is re-
evaluating living donor follow-up forms, developing strategies to 
improve their completeness, and considering the development of a living 
donor registry. Once data for national and transplant center-specific 
outcomes for living donors are readily available to transplant centers, 
centers must begin providing the data to living donors to assist them 
in making a decision whether to donate. In the interim, each center 
must provide whatever data are available on its own living donor 
outcomes to prospective living donors. Should national living donor 
data become available in the future, transplant centers must provide 
this information to prospective living donors. Thus, we have added 
language at Sec.  482.102(b)(6) that specifies living donors must be 
informed about national and center-specific outcomes for living donors, 
as data are available.

Notification to Patients

    Note that we have removed the phrase ``that meets the hospital's 
credentialing policies'' from the end of the sentence ``whether or not 
the center has a mechanism to provide an alternate transplant surgeon 
or transplant physician that meets the hospital's credentialing 
policies'' in Sec.  482.102(c)(1)(ii) of the proposed rule. A hospital 
where a transplant center is located should have a process for 
credentialing of its staff as required by Sec.  482.22. Therefore, a 
requirement for an alternate transplant surgeon or transplant physician 
``that meets the hospital's credentialing policies'' is unnecessary.

[[Page 15242]]

    Comment: Some commenters supported the requirement for a transplant 
center to notify patients of information that could impact the 
patients' ability to receive an organ. Such information would include 
informing patients of the possibility that a center's sole transplant 
team might be unavailable when an organ becomes available and whether 
the center has a mechanism to provide an alternate transplant surgeon 
or transplant physician. However, other commenters said that the 
requirement would be burdensome. They stated that a requirement to 
notify patients about short-term absences (for example, sickness, 
vacation, and conferences) would be unrealistic. The commenters 
suggested that a requirement to notify waiting list patients of the 
unavailability of the transplant surgeon or physician for more than 30 
days would be realistic.
    Response: We did not propose nor do we require in this final rule 
that transplant centers notify waiting list patients about specific 
absences as they occur. Instead, we are requiring a transplant center 
served by a single transplant surgeon or physician to inform each 
waiting list patient of the possibility that the center's transplant 
surgeon(s) or physician(s) may not be available at the time an organ 
becomes available. We also require a transplant center to tell each 
waiting list patient whether the center has a mechanism to provide an 
alternate transplant surgeon or physician.
    Comment: A commenter suggested that in the context of termination 
under Sec.  482.102(c)(2), which requires a transplant center whose 
Medicare approval is terminated to inform waiting list patients at 
least 30 days prior to the termination, we should modify the 30-day 
requirement by adding ``and following the exhaustion of all appeals 
provided pursuant to [part] 498 * * *.''
    Response: The general provisions under 42 CFR part 498 provide for 
an administrative judicial review of administrative determinations, for 
providers facing termination of Medicare approval. Thus, if a 
transplant center appeals a termination of Medicare approval under 42 
CFR, part 498, the termination will not occur until the appeals 
process, if any, is completed. Therefore, there is no need to 
incorporate the commenter's suggested language.
    Comment: A commenter stated that the proposed rule does not address 
how care would be provided for patients on the waiting list of a 
transplant center whose Medicare approval was terminated.
    Response: We disagree. Sections 482.102(c)(2)(i) and (ii) of both 
the proposed rule and this final rule provide that at least 30 days 
before a center's Medicare approval is terminated, whether voluntarily 
or involuntarily, the center must inform patients on the center's 
waiting list. The transplant center also must provide assistance to 
waiting list patients who choose to transfer to the waiting list of 
another Medicare-approved transplant center without loss of time 
accrued on the waiting list. Further, the transplant center must inform 
Medicare beneficiaries on the center's waiting list that Medicare will 
no longer pay for transplants performed at the center after the 
effective date of the center's loss of Medicare approval.
    This final rule adds a requirement at Sec.  482.102(c)(3) for 
patient notification if a transplant center voluntarily inactivates. We 
require that as soon as possible, prior to a transplant center's 
inactivation, the center must inform patients on the center's waiting 
list and, as directed by the Secretary, provide assistance to waiting 
list patients who choose to transfer to the waiting list of another 
Medicare-approved transplant center without loss of time accrued on the 
waiting list. As we stated earlier, we intend to monitor transplant 
center inactivity closely.

Condition of Participation: Additional Requirements for Kidney 
Transplant Centers (Proposed Sec.  482.104)

    We proposed to delete some sections from part 405, subpart U and 
move some of the sections in subpart U to this final rule.
    We proposed that kidney transplant centers be required to furnish: 
(a) Transplantation and other medical and surgical specialty services 
required for the care of ESRD patients; and (b) inpatient dialysis 
services, directly or under arrangement. We proposed that such kidney 
dialysis centers or units must meet the conditions for coverage of 
suppliers of ESRD services contained in part 405, subpart U.
    We proposed that kidney transplant centers would be required to 
cooperate with the ESRD Network designated for its geographic area in 
fulfilling the terms of the network's current statement of work.
    Following are summaries of the comments we received and our 
responses. Note that based on public comments summarized earlier in 
this preamble, we have added a requirement at Sec.  482.104(a) that a 
kidney transplant center must have written policies and procedures for 
ongoing communication with dialysis patients' local dialysis 
facilities.
    Comment: A commenter requested clarification about the extent to 
which a dialysis facility providing acute services to transplant 
recipients must meet the requirements of a chronic dialysis facility 
under the ESRD rule. Another commenter suggested deleting the proposed 
requirement for transplant centers that furnish inpatient dialysis 
services to meet the conditions for coverage for suppliers of ESRD 
Services contained in part 405 Subpart U. A commenter recommended that 
we add a new condition of participation for inpatient dialysis units to 
provide regulatory guidance for providers of inpatient dialysis 
services in acute care settings.
    Response: Based on these comments and further analysis of our 
proposal, we have concluded that it is unnecessary to require 
transplant centers that provide inpatient dialysis services to kidney 
transplant patients to comply with the Conditions for Coverage for 
Suppliers of ESRD Services in part 405 subpart U. Kidney transplant 
centers are located inside hospitals that must comply with the Medicare 
hospital CoPs, which include quality standards that apply to all 
services provided by hospitals. Since inpatient dialysis services 
furnished either directly by kidney transplant centers or under 
arrangement are subject to the requirements in the hospital CoPs, we 
see no need to regulate inpatient dialysis services separately.
    Therefore, we have removed the proposed requirement at Sec.  
482.104(b) that inpatient kidney dialysis centers or units must meet 
the Conditions for Coverage, part 405, subpart U for suppliers of ESRD 
services. We have retained in this final rule only the requirement that 
kidney transplant centers must furnish inpatient dialysis services 
directly or under arrangement. However, a kidney transplant center that 
furnishes outpatient dialysis services directly or under arrangement in 
dialysis centers or units is required to meet the Conditions for 
Coverage for Suppliers of ESRD Services contained in part 405, subpart 
U.
    Comment: A commenter suggested requiring transplant centers 
performing pediatric kidney transplants to provide inpatient pediatric 
dialysis services with appropriate pediatric equipment and nursing 
expertise.
    Response: We expect both pediatric and adult transplant centers to 
provide staffing, equipment, and other resources appropriate to the 
needs of their specific patient population. Since providing inpatient 
dialysis services to pediatric patients may require specialized

[[Page 15243]]

pediatric equipment and specific pediatric nursing expertise, we 
believe transplant centers should have the flexibility to determine how 
they will provide these services. We have made no changes in this final 
rule based on this comment.
    Comment: A few commenters supported the requirement for kidney 
transplant centers to remain associated with the ESRD Network. However, 
one commenter stated that the proposed requirement for participation in 
network activities is duplicative of 42 CFR part 405, subpart U and 
requested clarification.
    Response: Existing Sec. Sec.  405.2110 through 405.2112 contain 
provisions that relate to the designation and functions of the ESRD 
networks. These provisions focus primarily on the role and 
responsibilities of the ESRD networks. Although we do not believe the 
role and responsibilities of the networks need to be included in this 
final rule, we believe that kidney transplant centers must continue to 
share information and collaborate with the networks. Thus, under Sec.  
482.104(c), we are finalizing our proposal that kidney transplant 
centers must cooperate with the ESRD network designated for their 
geographical area in fulfilling the terms of the network's current 
statement of work.

Deeming Authority (Sec.  488.6)

    Under Sec.  1865 of the Act and Sec.  488.5 of the regulations, 
hospitals that are accredited by the Joint Commission on Accreditation 
of Healthcare Organizations (JCAHO) or the American Osteopathic 
Association (AOA) are not routinely surveyed by the State survey 
agencies for compliance with the CoPs. Instead, they are deemed to meet 
the requirements based on either their JCAHO or AOA accreditation. In 
order to receive this deemed status, hospitals as well as other 
providers and suppliers, which are accredited by JCAHO, AOA, or other 
national accreditation programs with deeming authority under Sec.  
488.6 of the regulations (see part 488, Survey and Certification 
Procedures), must meet requirements that are at least as stringent as 
the Medicare CoPs. Therefore, an accreditation organization could apply 
for and receive approval of deeming authority for the transplant center 
CoPs if the accreditation organization demonstrates that its 
requirements for transplant centers are at least as stringent as those 
in this final rule. In this final rule, we are amending Sec.  488.6, as 
described at 42 CFR part 488, subpart A, to include transplant centers, 
except for kidney transplant centers, among those providers and 
suppliers that are eligible to receive deemed status based on such an 
accreditation. A transplant center can choose to meet the requirements 
through the accreditation process or through a State survey. As a 
designee of CMS, an accrediting organization or a State survey agency 
must survey each transplant center's compliance with the clinical 
experience, outcome, data submission, and process requirements. In 
either case, the special procedures for transplant centers, as 
described under Sec.  488.61, will ultimately guide the survey process.

Special Procedures for Approval and Re-Approval of Organ Transplant 
Centers (Proposed Sec.  488.61)

    We proposed utilizing the survey, certification, and enforcement 
procedures described at 42 CFR part 488, subpart A, including the 
periodic review of compliance and approval contained in Sec.  488.20. 
We would retain Sec.  488.60 to apply exclusively to ESRD facilities. 
Following are summaries of the comments we received and our responses.
(a) Initial Approval Procedures
    We proposed that a transplant center would be permitted to submit a 
letter of request to us for Medicare approval at any time. We proposed 
that the letter, signed by a person authorized to represent the center, 
would have to include the hospital's Medicare provider I.D. number, 
name(s) of the designated primary transplant surgeon and primary 
physician, and a statement from the OPTN that the center had complied 
with all data submission requirements.
    We proposed that we or our designee would determine a transplant 
center's compliance with the data submission and outcome requirements 
proposed at Sec.  482.80(b) and (c). We or our designee would review 
the 1-year patient and graft survival data contained in the SRTR's most 
recent center-specific reports.
    We proposed that, if both of the conditions in Sec.  482.80(b)(4) 
applied, the center could ask the SRTR to prepare a customized report 
of the center's 1-month patient and graft survival data for the 
previous 1-year period. We or our designee would determine compliance 
with the outcome requirements contained at Sec.  482.80(b) using the 
data contained in these customized reports.
    We proposed that if we or our designee determined that a transplant 
center met the data submission and outcome requirements of Sec.  
482.80, we or our designee would conduct a survey and review the 
center's compliance with the conditions of participation contained at 
Sec.  482.68 through Sec.  482.76 and Sec.  482.90 through Sec.  
482.104, using the procedures described at 42 CFR part 488, subpart A.
    We proposed that if a transplant center seeking Medicare approval 
was found to be in compliance with all conditions of participation at 
Sec.  482.68 through Sec.  482.104, except for Sec.  482.82 (Re-
approval requirements), we would notify the transplant center in 
writing of the effective date of its Medicare approval or notify the 
transplant center in writing if it were not approved. We proposed that 
we would grant initial approval to a transplant center for 3 years.
(b) Re-Approval Procedures
    We proposed that once Medicare-approved, a transplant center would 
have to be in compliance with all conditions of participation for 
transplant centers at Sec.  482.68 through Sec.  482.104, except for 
Sec.  482.80 (Initial approval requirements) throughout the 3-year 
approval period.
    We proposed that at least 180 days before the end of the 3-year 
approval period, we or our designee would review the transplant 
center's data in making re-approval determinations.
    We proposed that: (1) To determine compliance with the data 
submission requirements at Sec.  482.82(a), we or our designee would 
request data submission data from the OPTN for the previous 3 calendar 
years; and (2) to determine compliance with the outcome requirements at 
Sec.  482.82(c), we or our designee would review the data contained in 
the most recent SRTR center-specific reports.
    We proposed that if we or our designee determined that a transplant 
center met the data submission and outcome requirements at Sec.  
482.82, the transplant center would be re-approved for 3 years.
    We proposed that if we or our designee determined that a transplant 
center failed to meet the data submission or outcome requirements 
contained at Sec.  482.82, the transplant center would be surveyed for 
compliance with Sec.  482.68 through Sec.  482.76 and Sec.  482.90 
through Sec.  482.104, using the procedures described at 42 CFR part 
488, subpart A.
    We proposed that we or our designee would notify the transplant 
center in writing if it were re-approved or if its approval were being 
revoked. If re-approved, we or our designee would notify the transplant 
center of the effective date of the re-approval.

[[Page 15244]]

(c) Loss of Medicare Approval
    We proposed that centers that lost their Medicare approval would be 
permitted to seek re-entry into the program at any time, using the 
procedures described at Sec.  488.61(a). We proposed that a center that 
lost its Medicare approval would be required to be in compliance with 
Sec. Sec.  482.68 through 482.104, except for Sec.  482.82 (Re-approval 
procedures), at the time of the request for Medicare approval. We 
proposed that a center seeking to re-enter the Medicare program would 
be required to submit a report documenting any changes or corrective 
actions the center took as a result of the loss of its Medicare 
approval status.
    We proposed that transplant centers with current Medicare approval 
would be permitted to continue to provide transplant services until we 
notified them whether they were approved under the new CoPs for 
transplant centers. For clarity we are adding the words ``OPTN Data 
Report'' to the regulation text for this section to describe the source 
of the data we will review to determine compliance with the clinical 
experience requirements. Following are summaries of the comments we 
received and our responses.

Initial Approval Procedures for New Transplant Centers

    Comment: Some commenters disagreed with the proposed process for 
initial approval of transplant centers, specifically, that if a center 
did not meet the data submission and/or outcome requirements, the 
center would not be considered for approval. Some commenters stated 
that data submission and outcome measures should be used only as 
indicators and not as pass/fail tests to approve centers. Other 
commenters suggested that the initial approval procedures should be 
similar to the proposed re-approval procedures, so that centers failing 
to meet the data and outcome requirements would not be denied Medicare 
approval automatically but would be surveyed to determine whether they 
should be approved.
    Response: In view of the public comments, as well as the potential 
disruption for Medicare beneficiaries if a large number of currently 
approved centers are denied initial approval under the requirements of 
this final rule, we will not deny initial approval to a transplant 
center automatically as we proposed at Sec.  488.61, if it fails to 
meet the data, clinical experience, or outcome requirements at Sec.  
482.80. Instead, we will take a flexible approach to our initial 
approval of transplant centers, as described at Sec.  488.61 in this 
final rule. For the initial approval process, we will conduct a follow-
up survey in all instances at currently Medicare-approved transplant 
centers if the center has not met the clinical experience and/or 
outcome requirements. We will exercise our discretion for new 
applications to the Medicare program. CMS will prioritize the 
scheduling of follow-up surveys based on the center's volume and 
outcome measurements and the program's history. CMS will survey these 
centers for the remaining conditions of participation and develop plans 
of correction for any condition or standard that is not met. If a 
center has ``failed'' the outcome measures, we will expect the plans of 
correction to include steps to improve these outcomes within a 
reasonable time frame (for example, by the next release of outcomes in 
the center-specific report).
    Thus, under this final rule at 488.61(a)(3), if we determine that a 
transplant center, including a kidney transplant center, applying for 
initial approval has not met the data submission, clinical experience, 
or outcome requirements, we may deny the request for approval or we may 
review the center's compliance with the conditions of participation at 
Sec.  482.72 through Sec.  482.76 and Sec.  482.90 through Sec.  
482.104, using the procedures described at 42 CFR part 488, subpart A, 
to determine whether the center's request should be approved. Our 
review may include a survey of the transplant center. We will notify 
the transplant center in writing whether its request has been approved 
and, if approved, the effective date of its approval.
    However, we will not grant initial approval unless: (1) The center 
has met or has come very close to meeting the data, clinical 
experience, and outcome requirements; and (2) the center is in 
compliance with all other conditions of participation. In the initial 
approval process, we will give the center an opportunity to correct any 
areas that do not meet the Conditions of Participation in a reasonable 
time period through a Plan of Correction that is developed by the 
Center, and approved and monitored by CMS.
    Following are examples of situations in which a transplant center 
applying for initial approval fails to meet the data submission, 
clinical experience, or outcome requirements and, for each example, an 
explanation of why we would or would not approve the center.

    Example 1: A large heart transplant center that is currently 
Medicare approved under the NCDs applies for initial approval under 
the new CoPs. The center consistently performs a large number of 
heart transplants annually and demonstrates superior performance on 
the outcome requirements. However, the transplant center has not met 
the data submission requirement by submitting 95 percent of the 
required data to the OPTN within 90 days of the due date. In fact, 
in the preceding 12 months, the transplant center submitted less 
than 90 percent of its transplant data within 90 days of the due 
date.
    Because of the transplant center's extensive clinical experience 
and superior outcomes, we perform a review of the center and 
determine that the center meets all conditions of participation 
other than the standard for data submission. The transplant center 
submits a plan of correction to us, demonstrating how it plans to 
come into compliance with the data submission requirement by hiring 
additional staff to collect transplant data and report it to the 
OPTN. We review and accept the plan of correction and approve the 
center.
    Example 2: A small, currently-approved liver transplant center 
applies for initial approval under the new CoPs. The center is the 
only liver center in a large western state that is primarily rural. 
The center meets the data submission requirement and its outcomes 
are acceptable. However, the center performed only 7 transplants in 
the preceding 12 months. Because the transplant center meets the 
data submission and outcome requirements and because it is the only 
liver transplant center in a largely rural state, we perform a 
review of the center and determine that it meets all the standards 
other than the clinical experience requirement. The center submits a 
plan of correction, detailing how it will attempt to meet the 
clinical experience requirement in the future (for example, by 
accepting more extended criteria organs for its patients). We accept 
the plan of correction and approve the center.
    Example 3: A small kidney center that is currently approved 
under the ESRD CfCs applies for approval under the new CoPs. The 
kidney center meets the data submission requirement. The center 
performed 2 of the 10 transplants in the preceding 12 months and its 
outcomes are slightly below what is required under the CoPs. 
Although the center failed to meet both the clinical experience and 
the outcome requirements, we will review the transplant center's 
compliance with the other conditions of participation before making 
a decision on its request for approval. However, it is unlikely that 
we will grant approval under such conditions.
    Example 4: A lung center located in a large city in the 
northeastern United States applies for Medicare approval under the 
requirements in the final rule. The lung center is currently 
Medicare approved. The center meets the data submission and clinical 
experience requirements. However, the center's 1-year observed 
patient and 1-year observed graft survival has been considerably 
below its expected 1-year expected patient and 1-year expected graft 
survival for the entire 2.5 year cohort. The center's outcomes show 
no sign of trending upward. We deny the center's request for 
approval. The center is free to re-apply at any time.


[[Page 15245]]


    In summary, the flexibility of the initial approval process in this 
final rule will permit us to survey and possibly approve transplant 
centers that fail to meet the data submission, clinical experience, or 
outcome requirements when there are mitigating circumstances or when a 
transplant center's reported outcomes do not reflect the general high 
quality of its transplantation services. Based on the comments we 
received, Sec.  488.61(a)(3) has been revised to read ``If CMS 
determines that a transplant center has not met the data submission, 
clinical experience, and outcome requirements, CMS may deny the request 
for approval or may review the center's compliance with the conditions 
of participation at Sec.  482.72 through Sec.  482.76 and Sec.  482.90 
through Sec.  482.104, using the procedures described at 42 CFR part 
488, subpart A, to determine whether the center's request will be 
approved. CMS will notify the transplant center in writing whether it 
is approved and, if approved, the effective date of its approval.''

Initial Approval Procedures For Centers With Current Medicare Approval

    Comment: Commenters objected to the proposed requirement that all 
transplant centers with current Medicare approval must apply for 
initial approval under the CoPs.
    Response: We do not believe it would be in the best interests of 
Medicare beneficiaries awaiting organ transplants to automatically 
approve centers with current Medicare approval because these centers 
were approved under NCDs for heart, liver, lung, and intestine centers 
or the ESRD CfCs for kidney transplant centers, which are different in 
many aspects from the CoPs in this final rule. For example, there are 
no outcome requirements for kidney transplant centers in the ESRD CfCs. 
Further, we know that some extra-renal transplant centers that were 
approved based on NCD criteria no longer meet those criteria. 
Therefore, automatically approving centers with current Medicare 
approval has the potential to permit a number of poor or marginal 
performers to continue to participate in Medicare. Based on these 
considerations, prior to approving currently approved transplant 
centers under our new requirements, we must first verify that they meet 
the CoPs in this final rule. The requirement for all currently-approved 
transplant centers to re-apply for initial approval under these new 
standards is consistent with our goals to increase transparency in the 
approval process and strengthen our oversight authority.
    We expect all transplant centers, including kidney transplant 
centers, that are Medicare approved as of the effective date of this 
final rule that wish to continue to provide services to Medicare 
beneficiaries to be in compliance with the CoPs at Sec. Sec.  482.72 
through 482.104, as of the effective date of this final rule. Such 
transplant centers have 180 days from the effective date of this final 
rule to submit a request for Medicare approval under the CoPs at 
Sec. Sec.  482.72 through 482.104, using the process described at Sec.  
488.61(b).
    CMS will consider mitigating factors, including (but not limited 
to) the following in considering approval of a transplant center that 
does not meet the conditions of participation: the extent to which 
outcome measures are met or exceeded, availability of Medicare-approved 
transplant centers in the area, and extenuating circumstances (e.g., 
natural disaster) that may have a temporary effect on meeting the 
conditions of participation. In addition, the transplant center must 
submit to CMS and implement a plan of correction to meet the conditions 
of participation.
    We will determine whether to approve the transplant center using 
the procedures described in paragraphs Sec.  488.61(a)(2) through 
(a)(5). Until we make a determination whether to approve the transplant 
center's request for approval, the transplant center will continue to 
be approved under the ESRD CfCs (for kidney transplant centers) or the 
pertinent NCDs (for extra-renal transplant centers), as applicable. The 
transplant center will continue to be reimbursed for services provided 
to Medicare beneficiaries.
    Once we approve a kidney transplant center under the CoPs, the ESRD 
CFCs will no longer apply to the transplant center as of the date of 
its approval. Once we approve an extra-renal transplant center under 
the conditions of participation, the NCDs will no longer apply to the 
transplant center as of the date of its approval. (See Sec.  
488.61(b).) Until we approve a currently approved transplant center 
under the CoPs in this final rule, the transplant center must continue 
to comply with the requirements in the NCDs or the ESRD CFCs, as 
applicable.
    If a transplant center that is Medicare approved as of the 
effective date of this final rule does not submit a request to us for 
Medicare approval under the CoPs at Sec. Sec.  482.72 through 482.104 
within 180 days after the effective date of the final rule, or if the 
transplant center applies timely, but we do not approve the transplant 
center under the CoPs in this final rule, we will revoke the transplant 
center's approval under the CfCs for kidney transplant centers or the 
NCDs for extra-renal transplant centers, as applicable, and the 
transplant center will no longer be reimbursed for services provided to 
Medicare beneficiaries. CMS will notify the transplant center in 
writing of the effective date of its loss of Medicare approval.

Re-Approval Procedures

    We asked the public and the five peer reviewers to comment on the 
following re-approval issues: (1) The feasibility and utility of the 
alternative approach to re-approve transplant centers based on random 
surveys; (2) methodology for selecting a random sample for surveys; (3) 
the necessity of surveying all centers every 3 years, regardless of 
their compliance with data submission and outcome measure requirements; 
and (4) the appropriateness of making re-approval survey decisions 
based on OPTN information (that is desk review, on-site audits and 
action(s) taken since last Medicare approval).
    Following are the comments we received and our responses.
(1) The Feasibility and Utility of the Alternative Approach To Re-
Approve Transplant Centers Based on Random Surveys
    Comment: A peer reviewer agreed that a transplant center's 
compliance with data submission and outcome measure requirements by 
itself is not sufficient evidence for CMS to grant Medicare re-
approval. However, two peer reviewers did not agree with using random 
surveys to identify transplant programs with deficiencies and stated 
that random surveys would miss many programs whose performance may 
warrant a survey. One peer reviewer supported using random surveys to 
re-approve transplant centers and believed it to be a systematic 
approach to assess transplant centers. One peer reviewer stated that 
Medicare's re-approval process should rely on the OPTN's monitoring and 
oversight process for transplant centers.
    Many public commenters also agreed with our concern that a center's 
compliance with data submission and outcome requirements may not 
necessarily indicate a center is also in compliance with the process 
requirements. These commenters supported targeted or random surveys to 
determine re-approval decisions. However, one commenter said that 
random surveys for re-approval are unnecessary if a center has 
demonstrated consistent compliance with the requirements.

[[Page 15246]]

    Response: We recognize that transplant center performance varies 
greatly and random surveys of centers may not be able to identify all 
poor performers. After carefully evaluating all the comments and taking 
into consideration the results of our recent survey of transplant 
centers, we believe finite resources are best used to survey the 
poorest performers and centers with significant deficiencies. 
Therefore, we will not perform random surveys as part of the re-
approval process for transplant centers. Instead, we will review 
centers that do not meet the data submission, clinical experience, and 
outcome requirements for compliance with the CoPs before making our re-
approval decision. The review may include an on-site visit. Under the 
final rule at Sec.  488.61(c)(2), if we determine that a transplant 
center has not met the data submission, clinical experience, or outcome 
requirements at Sec.  482.82, the transplant center will be reviewed 
for compliance with the conditions of participation at Sec.  482.72 
through Sec.  482.76 and Sec.  482.90 through Sec.  482.104, using the 
procedures described at 42 CFR part 488, subpart A. Under the final 
rule at Sec.  488.61(c)(3), if we determine that a transplant center 
has met the data submission, clinical experience, and outcome 
requirements at Sec.  482.82, we may choose to review the transplant 
center for compliance with the conditions of participation at Sec.  
482.72 through Sec.  482.76 and Sec.  482.90 through Sec.  482.104, 
using the procedures described at 42 CFR part 488, subpart A.
    CMS will consider mitigating factors, including (but not limited 
to) the following in considering approval of a transplant center that 
does not meet the conditions of participation: The extent to which 
outcome measures are met or exceeded, availability of Medicare-approved 
transplant centers in the area, and extenuating circumstances (e.g., 
natural disaster) that may have a temporary effect on meeting the 
conditions of participation. In addition, the transplant center must 
submit to CMS and implement a plan of correction to meet the conditions 
of participation.
    During the Medicare approval cycle, a transplant center will be 
reviewed at some point to ensure it is in compliance with the CoPs. The 
existing complaint investigation process and the use of relevant data, 
including the OPTN data, are good tools to identify centers with 
deficiencies.
    As stated earlier, the OPTN and CMS oversight have a different 
focus, and they compliment each other. Therefore, we disagree with the 
commenter that OPTN oversight can substitute for CMS oversight. 
Further, we do not have the statutory authority to delegate regulatory 
authority to the OPTN to regulate transplant centers. No changes have 
been made in this final rule based on this comment.
(2) Methodology To Select a Random Sample for Surveys
    Comment: Most peer reviewers had no comments on this issue. One 
peer reviewer suggested that 5-10% of small and large organ-specific 
centers should be selected for random surveys.
    Response: We thank the peer reviewer for his suggestions. However, 
as stated in our responses earlier, we are not using random surveys to 
make re-approval decisions in this final rule. No changes have been 
made based on this comment.
(3) Whether Centers Should Be Surveyed Once Every 3 Years, Regardless 
of Their Compliance With Data Submission and Outcome Measure 
Requirements
    Comment: A few commenters recommended surveying only centers that 
fail to comply with data submission and outcome measure requirements 
every 3 years. A commenter stated that all centers should be surveyed 
for compliance with the process requirements every 3 years, regardless 
of whether they are in compliance with data and outcome requirements. 
The commenter suggested allowing a plan of correction if a center is 
out of compliance with one or more conditions for coverage. Another 
commenter recommended that re-approval surveys be conducted only when a 
center has become an OPTN ``member not in good standing'' and only 
after exhaustion of all OPTN appeals processes and remedies. A 
commenter recommended that transplant centers be subject to only one 
survey every 3 years by either the OPTN or CMS but not both because 
surveys are burdensome, bureaucratic, and costly.
    Two peer reviewers supported routine periodic survey of transplant 
centers for the purposes of: (1) Validating the timeliness and accuracy 
of data submission, (2) enhancing transplant centers' self-assessment 
process, and (3) sharing best practices to improve performance. A peer 
reviewer recommended surveying only centers that fail to comply with 
data submission and outcome measure requirements every 3 years. One 
peer reviewer stated that routine surveys are burdensome for centers 
that are performing well.
    Response: We agree with the commenters and peer reviewers that 
transplant centers' data submission and outcome performance should be 
reviewed regularly to ensure they are in compliance with all of our 
requirements, even if they are consistently in compliance with data 
submission and clinical experience requirements. Nonetheless, we are 
also mindful of the potential burden on centers that are in compliance 
with the CoPs. Therefore, we will minimize the burden for transplant 
centers by conducting targeted re-approval surveys. For example, a 
center that barely meets the outcome requirements may be surveyed every 
3 years, while a center that consistently has superior outcomes may be 
surveyed less often.
    As stated previously, transplant centers will be subject to the 
same remediation process, including plans of correction, used for 
nearly all other Medicare providers and suppliers.
    Also, we disagree with the commenter's suggestion to use the OPTN 
membership status of ``not in good standing'' as a trigger for surveys 
because the OPTN may designate a member as ``not in good standing'' for 
reasons that have nothing to do with the center's compliance with CMS's 
regulatory requirements (for example, OPTN organ allocation policies). 
If a transplant center were to become an OPTN ``member not in good 
standing,'' we most likely would treat the member's status with the 
OPTN as a complaint and conduct a survey of the center to determine its 
compliance with our regulatory requirements. If a Medicare provider is 
substantially out of compliance with our conditions of participation, 
we must take independent action promptly to oversee the provider's 
development and implementation of a plan of correction. We must base 
our decision whether to review or survey a center on issues that 
directly relate to the requirements in this final rule. Therefore, no 
changes have been made based on this comment.
    Comment: Some commenters supported the re-approval procedures for 
Medicare-approved transplant centers and the 3-year re-approval cycle. 
However, some commenters suggested extending the approval cycle to 5 or 
6 years.
    Response: We agree with the commenters that centers should be 
monitored and re-approved every 3 years. Ongoing evaluation is critical 
to ensure that after Medicare approval, a center continues to meet 
Medicare requirements. Frequent, active oversight of transplants 
centers helps to ensure that Medicare beneficiaries continue to receive 
high quality transplantation services. We disagree that 5 or 6 years is 
an appropriate time period for re-

[[Page 15247]]

approval. Given rapid changes in the field of transplantation, a 
center's performance may change radically in 5 or 6 years from its 
initial Medicare approval.
    Comment: A peer reviewer requested clarification on whether CMS 
will rely on the OPTN's Membership and Professional Standards 
Committee's (MPSC) extensive method to flag centers for further review 
or develop a similar method for this scrutiny.
    Response: We plan to convene a technical expert panel to develop a 
similar methodology for targeting transplant centers for survey. 
However, we expect to minimize burden for transplant centers by 
conducting targeted re-approval surveys.
    Comment: A peer reviewer favored a periodic ``self-study'' report 
by all programs regarding the state of their compliance with process 
requirements. A robust self-study process could potentially eliminate 
the need for, or reduce the frequency of, on-site surveys.
    Response: We welcome the idea of transplant centers performing 
periodic ``self-study'' to assess their compliance with the process 
requirements. We urge transplant centers to consider incorporating a 
robust self-study process to enhance their preparedness for surveys. No 
changes have been made based on this comment.
(4) Use of OPTN Information To Identify Centers That Need To Be 
Surveyed
    Comment: Many commenters agreed that it would be appropriate to 
make survey decisions based on OPTN information since it is widely 
accepted by U.S. health care payers. Nonetheless, a peer reviewer 
cautioned that routine use of OPTN information may alter the generally 
collegial responses that the OPTN receives from transplant programs. 
Transplant centers may become less open, less responsive, and more 
guarded. The peer reviewer said that this possibility should be 
carefully considered if the OPTN information-based survey approach is 
taken. The peer reviewer also recommended that we clearly define the 
thresholds for passing OPTN information to CMS.
    Another peer reviewer was concerned that the sharing of OPTN data 
with CMS jeopardizes the confidentiality of transplant centers' data 
submissions to the OPTN under applicable laws and regulations 
protecting peer review processes employed by the OPTN committees. The 
reviewer recommended adding language to note that nothing in the final 
rule changes existing OPTN rules and policies with respect to 
confidentiality of data obtained from centers, as part of its oversight 
and compliance obligations.
    Response: We agree that the use of OPTN information for survey 
decisions is appropriate since it is transparent, acceptable to the 
transplant community, and is publicly available. We will use relevant 
information such as OPTN data to prioritize survey decisions.
    We do not believe the sharing of OPTN data with us jeopardizes the 
confidentiality of transplant centers' data under applicable laws and 
regulations because the OPTN final rule at 42 CFR part 121, states in 
Sec.  121.11(b)(1)(iii) that the OPTN and the SRTR, as appropriate, 
shall provide to the Secretary any data that the Secretary requests. 
Because of the language in part 121, we do not see a need to add 
clarifying language with respect to confidentiality of data obtained 
from centers. We expect the OPTN/MPSC to continue its review process to 
flag centers for further review and we expect that centers will 
continue to maintain their collegial relationships with the OPTN.
    Comment: A public commenter asked whether CMS or some other agency 
or organization will monitor transplant center's compliance with the 
outcome requirements. One commenter recommended that CMS consult with 
the OPTN.
    A peer reviewer stated that we need to delineate the methodology we 
will use to survey transplant centers, identify the designated 
organization that will perform the surveys, and provide assurance that 
the organization has the experience and expertise to perform transplant 
center surveys.
    Response: Although we have not yet determined which entity will 
monitor extra-renal transplant centers, we will inform them as soon as 
possible. Kidney transplant centers will not be monitored by any of the 
national accrediting bodies. Pursuant to sections 1865(b)(1) and 
1881(b) of the Act, kidney transplant centers cannot be deemed by a 
national accreditation body to meet the Medicare conditions of 
participation. If a national accrediting organization applies for 
deeming authority for any of the extra-renal transplant centers, we 
will assess its expertise and review its application. If an accrediting 
organization is approved for deeming authority the transplant centers 
will be routinely reviewed (which could include surveys) by the 
accrediting organization. We will continue to have oversight 
responsibility for complaint surveys and validation surveys and will 
work closely with the accrediting organization on an ongoing basis. 
Most transplant centers are located in accredited hospitals and surveys 
of the transplant center may be combined with the routine survey of the 
hospital which may allow for a more efficient review since some of the 
transplant center documentation and records will be combined with the 
hospital records. We will include information about how transplant 
center surveys will be performed in the Interpretive Guidelines that we 
will develop following publication of the final rule. Under this final 
rule, we will monitor transplant center compliance with the clinical 
experience and outcome requirements. We will continue to work with the 
OPTN through HRSA on transplant center issues.

Accreditation, Corrective Actions, Appeal Process and Loss of Medicare 
Approval

    We requested comments on whether transplant centers should be 
regarded as providers or as suppliers for the purpose of appealing 
adverse approval and re-approval decisions.
    Comment: A commenter suggested that transplant centers should be 
identified as a provider in the regulations for accreditation and 
appeals purposes. One commenter suggested that the part 498 appeals 
process is an appropriate mechanism for transplant center appeals. 
Another commenter requested that we state clearly that the denial of 
initial approval and re-approval is a determination that triggers 
appeal rights under part 498.
    Response: We agree with the commenter that transplant centers 
should have provider status for accreditation and appeals purposes 
because transplant centers are located within hospitals, which are 
considered providers under the Medicare program. Therefore, we have 
added transplant centers to the list of providers in 42 CFR 498.2 that 
have the right to appeal decisions that affect their participation in 
the Medicare program. Additionally, we have added transplant centers to 
the list of providers and suppliers in 42 CFR 488.6 that can receive 
deemed status through an accrediting organization. Transplant centers 
that apply for and are denied Medicare approval, as well as Medicare-
approved transplant centers that are terminated from the Medicare 
program may appeal these decisions under part 498.
    Comment: A few commenters recommended that a center should be 
allowed to continue Medicare participation pending exhaustion of any 
appeals, provided that its treatment of Medicare beneficiaries does not 
jeopardize their health and safety.

[[Page 15248]]

    Response: In most cases, Medicare providers and suppliers are 
permitted to continue to participate in Medicare while an appeal is 
pending, unless the deficiency is such that the health and safety of 
patients is in immediate jeopardy.
    Comment: Many commenters asked us to clarify whether transplant 
centers that do not meet the data and outcome requirements in the 
initial approval and re-approval process will have an opportunity for 
corrective action. A commenter suggested that we should provide a 
process of remediation and corrective actions for centers that fail to 
comply with the data submission and outcome requirements that is like 
the process for hospitals that face termination from the Medicare 
program. A commenter recommended 180 days for centers to submit 
acceptable plans of correction and correct deficiencies through the use 
of an acceptable QAPI program. Another commenter stated that we should 
consult with the OPTN before denying re-approval of Medicare-approved 
centers. A commenter suggested that we should review a center for 
potential termination of Medicare approval only when the Secretary has 
been notified of an OPTN decision to take adverse action against the 
center. A commenter recommended that we adopt the OPTN remediation 
process for centers failing to meet outcome requirements.
    Response: Once approved under the requirements of this final rule, 
transplant centers will be subject to the same remediation process used 
for nearly all other Medicare providers and suppliers. Under the 
process for re-approval, a transplant center found to be out of 
compliance with one or more CoPs, including the CoP for data 
submission, clinical experience, and outcome requirements, will have an 
opportunity to come back into compliance once it has submitted an 
acceptable plan of correction. Generally, the transplant center will be 
permitted to continue to provide services to Medicare beneficiaries 
while we monitor implementation of the plan of correction. We also will 
use this process if we find, during a complaint investigation, that a 
transplant center is out of compliance with one or more conditions of 
participation. We do not have a remediation or corrective action 
process for entities that apply for initial Medicare certification or 
approval under this final rule and fail to meet the requirements. 
However, a transplant center that is not approved may re-apply for 
initial approval at any time.
    We will include additional details about the processes for initial 
approval and re-approval, plans of correction, and other matters 
related to survey and certification of transplant centers in 
Interpretive Guidelines for surveyors and manual instructions that will 
be published following the effective date of this final rule.

III. Provisions of the Final Rule

    In the final rule, we are adopting the provisions as set forth in 
the February 4, 2005 proposed rule with the following revisions:
    Amend Sec.  482.70, ``Definitions,'' by--
     Revising the term ``adverse event.'' The proposed 
definition listed two examples of adverse events related to living 
donors: ``living donor death due to mismanagement of the donor'' and 
``avoidable loss of a healthy living donor.'' We have replaced these 
two examples with ``serious medical complications or death caused by 
living donation'' to clarify that the death or serious medical 
complications due to living donation of any living donor should be 
investigated as an adverse event. The proposed definition also listed 
another example of an adverse event as ``transplantation of organs of 
mismatched blood types due to failure to validate the donor and 
recipient's vital information.'' We have revised this example to now 
read ``unintentional transplantation of organs of mismatched blood 
types'' in order to further clarify this term.
     Removing the term ``intestinal'' wherever it appears, when 
referring to such transplants and transplant centers, and adding in its 
place the term ``intestine.''
    Amend Sec.  482.72, ``Condition of participation: OPTN 
membership,'' by--
     Revising the beginning of the last sentence in the 
condition statement by changing it from ``No transplant hospital * * 
*'' to ``No hospital that provides transplantation services * * *''
    Amend Sec.  482.74, ``Condition of participation: Notification to 
CMS,'' by--
     Redesignating the proposed introductory text as paragraph 
(a) and proposed paragraphs (a) and (b) as paragraphs (a)(1) and (a)(2) 
respectively.
     Revising the newly redesignated paragraph (a) to read ``A 
transplant center must notify CMS immediately of any significant 
changes related to the center's transplant program or changes that 
could affect its compliance with the conditions of participation. 
Instances in which CMS should receive information for follow up, as 
appropriate, include, but are not limited to: * * *''
     Redesignating Sec.  482.100(b) as Sec.  482.74(a)(3) and 
revising newly designated paragraph (a)(3).
     Adding a new paragraph (a)(4) to clarify that a transplant 
center must notify CMS immediately of its inactivation.
     Adding a new paragraph (b) to specify the actions CMS will 
take to follow-up with a transplant center that notifies us of 
significant changes in their program.
    Amend Sec.  482.76, ``Condition of participation: Pediatric 
transplants,'' by--
     Removing the word ``wishes'' and adding in its place 
``seeks Medicare approval'' in the condition statement to clarify that 
it is only those centers seeking Medicare approval to perform pediatric 
transplants that must submit a request for this specific purpose.
     Adding the phrase ``in a 12-month period'' after ``A 
center that performs 50 percent or more of its transplants,'' at 
proposed Sec.  482.76(b) to clarify that a center that performs 
predominately adult transplants must be approved to perform adult 
transplants in order to be approved to perform pediatric transplants.
     Adding the phrase ``in a 12-month period'' after ``A 
center that performs 50 percent or more of its transplants'' at 
proposed Sec.  482.76(c) to clarify that a center that performs 
predominately pediatric transplants must be approved to perform 
pediatric transplants in order to be approved to perform adult 
transplants.
     Revising proposed Sec.  482.76(c)(3) to read ``A center 
that performs 50 percent or more of its transplants on pediatric 
patients in a 12-month period is not required to meet the clinical 
experience requirements prior to its request for approval as a 
pediatric transplant center.
     Adding the citation of ``Omnibus Budget and Reconciliation 
Act (OBRA) 1987 criteria in section 4009(b) (Pub. L. 100-203)'' at 
paragraph (d) to clarify that the alternate criteria for Medicare 
approval of heart transplant centers providing transplantation services 
to pediatric heart patients are mandated by statute, and in paragraph 
(d)(1) changing the word ``center'' to ``hospital'' to conform with the 
language in OBRA 1987.
    Amend Sec.  482.80, ``Condition of participation: Data submission 
and outcome requirements for initial approval of transplant centers,'' 
by--
     Adding the phrase ``clinical experience'' to the CoP 
section heading and to the condition statement to clarify that there is 
a clinical experience requirement, and so that the heading now reads 
``Data submission, clinical experience, and outcome requirements for 
initial approval of transplant

[[Page 15249]]

centers.'' (The appropriate revisions regarding the clinical experience 
requirements for approval and re-approval, including the special 
procedures for approval and re-approval described at Sec.  488.61, have 
been made throughout the final rule.)
     Revising the condition statement. Throughout the proposed 
rule the terms ``outcome measure'' and ``outcome measure standards'' 
are used. We have replaced both terms with ``outcome requirements'' 
here and throughout the final rule in order to clarify, through the use 
of a uniform term throughout, that these are requirements and not 
measures or standards. We have done this, along with our removal of the 
reference to waivers in the proposed rule, in order to further clarify 
that centers not meeting the data submission, clinical experience, and 
outcome requirements may be reviewed to augment CMS's approval 
decisions.
     Removing in paragraph (a) ``transplant recipient 
registration, and recipient follow-up'' and adding in its place the 
words ``transplant recipient registration and follow-up.'' In addition, 
adding at the end of paragraph (a) ``and living donor registration and 
follow-up'' to clarify that they are part of the required data 
submissions.
     Adding a new paragraph (b), Standard: Clinical Experience 
requirements. An organ-specific transplant center generally must 
perform 10 transplants over a 12-month period.
     Re-designating proposed Sec.  482.80 paragraph (b) as 
paragraph (c) and revising the paragraph heading to now read ``(c) 
Standard: Outcome requirements.'' All references to this paragraph have 
been amended accordingly.
     Revising proposed Sec.  482.80 paragraph (b)(1) (now 
(c)(1)) by removing the words `` as long as the center has 1-year post-
transplant follow-up on at least 9 transplants of the appropriate organ 
type.''
     Revising proposed Sec.  482.80 paragraph (b)(2) (now 
(c)(2)) by removing the words ``The 9'' and adding in its place the 
words ``The required number of'' so that the paragraph now reads: ``The 
required number of transplants must have been performed during the time 
frame reported in the most recent SRTR center-specific report.''
     Removing proposed Sec.  482.80 paragraphs (b)(4), (b)(5), 
and (b)(6) to clarify that a center may not request CMS to review its 
1-month patient and graft survival outcomes for all transplants 
performed in the previous 1-year period in lieu of 1-year patient and 
graft survival outcomes if certain conditions are met. We are not 
finalizing the proposed review of 1-month post-transplant data of new 
centers seeking Medicare approval.
     Re-designating proposed Sec.  482.80 paragraph (c) as 
paragraph (d) with the heading continuing to read ``Exceptions.'' All 
references to this paragraph have been amended accordingly.
     Revising newly re-designated paragraph (d)(1) to clarify 
that heart-lung transplant centers are not required to meet the 
clinical experience requirements or the outcome requirements for heart-
lung transplants performed at the center.
     Revising newly re-designated paragraph (d)(2) to clarify 
that intestine transplant centers are not required to meet the outcome 
requirements for intestine, combined liver-intestine, or multivisceral 
transplants performed at the center.
     Revising newly re-designated paragraph (d)(3) to clarify 
that pancreas transplant centers are not required to meet the clinical 
experience requirements or the outcome requirements for pancreas and 
kidney-pancreas transplants performed at the center.
     Removing in newly re-designated paragraph (d)(4) the words 
``perform a minimum number of pediatric transplants'' and adding in its 
place the words ``comply with the clinical experience requirements in 
paragraph (b)'' to clarify that a center requesting initial Medicare 
approval to perform pediatric transplants does not have to comply with 
the clinical experience requirements prior to its request for approval 
as a pediatric transplant center.
     Adding paragraph (d)(5) to state that ``a kidney 
transplant center that is not Medicare-approved on the effective date 
of this final rule is required to perform at least 3 transplants over a 
12-month period prior to its request for initial approval.''
    Amend Sec.  482.82 ``Condition of participation: Data submission 
and outcome requirements for re-approval of transplant centers'' by--
     Adding the phrase ``clinical experience'' to the CoP 
section heading and to the condition statement to clarify that there is 
a clinical experience requirement, and so that the heading now reads 
``Data submission, clinical experience, and outcome requirements for 
re-approval of transplant centers.''
     In paragraph (a), revising ``transplant recipient 
registration, and recipient follow-up'' to read ``transplant recipient 
registration and follow-up.'' In addition, adding the words ``and 
living donor registration and follow-up'' at the end of paragraph (a) 
to clarify that they are part of the required data submission.
     Adding a new paragraph (b), Standard: Clinical experience 
requirements. An organ-specific transplant center must generally 
perform an average of 10 transplants per year during the re-approval 
period.
     Re-designating proposed paragraph (b) as paragraph (c) and 
revising the paragraph heading to now read ``(c) Standard: Outcome 
requirements.'' All references to this paragraph have been amended 
accordingly.
     Revising proposed paragraph (b)(1) (now (c)(1)) by 
removing the phrase ``as long as the center has 1-year post-transplant 
follow-up on at least 9 transplants of the appropriate organ type.''
     Revising proposed Sec.  482.82 paragraph (b)(2) (now 
(c)(2)) by removing the words ``The 9'' and adding in its place the 
words ``The required number of'' so that it now reads: ``The required 
number of transplants must have been performed during the time frame 
reported in the most recent SRTR center-specific report.''
     Re-designating proposed Sec.  482.82 paragraph (c) as 
paragraph (d) with the paragraph heading continuing to read 
``Exceptions.'' All references to this paragraph have been amended 
accordingly.
     Revising newly re-designated paragraph (d)(1) to clarify 
that heart-lung transplant centers are not required to meet the 
clinical experience requirements or the outcome requirements for heart-
lung transplants performed at the center.
     Revising newly re-designated paragraph (d)(2) to clarify 
that intestine transplant centers are not required to meet the outcome 
requirements for intestine, combined liver-intestine, or multivisceral 
transplants performed at the center.
     Revising newly re-designated paragraph (d)(3) to clarify 
that pancreas transplant centers are not required to meet the clinical 
experience requirements or the outcome requirements for pancreas and 
kidney-pancreas transplants performed at the center.
     Revising newly re-designated paragraph (d)(4) by removing 
the phrase ``perform a minimum number of pediatric transplants'' and 
adding in its place the words ``comply with the clinical experience 
requirements in paragraph (b)'' in order to clarify that a center does 
not have to comply with the clinical experience requirements to be re-
approved.

[[Page 15250]]

    Amend Sec.  482.90 ``Condition of participation: Patient and living 
donor selection'' by--
     Removing the word ``waitlist'' and adding in its place the 
words ``waiting list'' in the condition statement and throughout the 
requirements where applicable.
     Removing proposed paragraph (a)(1) and re-designating 
paragraphs (a)(2), (a)(3), and (a)(4) as paragraphs (a)(1), (a)(2), and 
(a)(3).
     Revising newly re-designated paragraph (a)(1) by adding 
the words, ``if possible'' at the end of the sentence to allow 
transplant centers the discretion to give psychosocial evaluation to 
prospective transplant candidates.
     Adding the words ``transplant patient'' to paragraph 
(a)(4) which reads ``A transplant center must provide a copy of its 
patient selection criteria to a transplant patient or dialysis 
facility, if requested by such transplant patient or facility.''
     Removing the words ``transplant candidate's'' in proposed 
paragraph (b)(2) so that the transplant center is only required to 
document the living donor's suitability for donation in the living 
donor's medical record.
    Revise Sec.  482.92 ``Condition of participation: Organ recovery 
and receipt'' by--
     Revising the first line of the condition statement to read 
``Transplant centers must have written protocols for validation of 
donor-recipient blood type and other vital data for the deceased organ 
recovery, organ receipt, and living donor organ transplantation 
process.''
     Adding the phrase ``When the identity of an intended 
transplant recipient is known and the transplant center sends a team to 
recover organ(s),'' at the beginning of paragraph (a) to clarify that 
if the intended recipient for the organ being recovered is known, the 
transplant center's recovery team must review and compare the donor 
data with the recipient blood type and other vital data before organ 
recovery takes place.
     Adding the phrase ``a licensed health care professional'' 
to paragraph (b) to clarify that this individual must be present for 
the verification of donor's blood type and vital data when an organ 
arrives at the transplant center.
    Amend Sec.  482.94 ``Condition of participation: Patient and living 
donor management'' by--
     Removing the word ``pre-transplant'' in the condition 
statement and in paragraph (a)(1) to clarify that a transplant center 
is not required to provide the care of a multidisciplinary patient care 
team coordinated by a physician in the pre-transplant phase of 
transplantation.
     Removing the words ``on an ongoing basis'' in paragraph 
(b)(1) and adding them to paragraph (b) introductory text to clarify 
that transplant centers must keep their waiting lists up to date on an 
ongoing basis.
     Adding the phrase ``(and in the case of a kidney patient, 
the patient's usual dialysis facility)'' in paragraph (c)(1) to clarify 
that the dialysis facility of the kidney transplant patients must also 
be notified of the patient's transplant status''.
     Adding the phrase ``(and in the case of a kidney patient, 
the patient's usual dialysis facility)'' in paragraph (c)(2) to clarify 
that the dialysis facility of the kidney transplant patients must also 
be notified of the kidney patient's removal from the waiting list for 
any reason other than death or transplantation no later than 10 days 
after the date the patient was removed from the waiting list.
     Removing the requirement in proposed (c)(2)(i)that once a 
patient is placed on a center's waiting list, the center must document 
in the patient's record that the patient is notified of his or her 
placement status at least once a year, even if there is no change in 
the patient's placement status. We are not finalizing this proposed 
requirement.
     Re-designating the proposed paragraph (c)(2)(ii) as 
paragraph (c)(2).
     Removing proposed paragraph (c)(3).
     Revising proposed paragraph (c)(4)(i) to replace the word 
``pre-transplant'' with ``transplant.''
     Re-designating proposed paragraph (c)(4) as paragraph 
(c)(3).
     Revising proposed paragraph (d) to now define a qualified 
social worker as ``an individual who meets licensing requirements in 
the State in which he or she practices; and (1) Has completed a course 
of study with specialization in clinical practice, and holds a masters 
degree from a graduate school of social work accredited by the Council 
on Social Work Education; or (2) Is working as a social worker in a 
transplant center as of the effective date of this final rule and has 
served for at least 2 years as a social worker, 1 year of which was in 
a transplantation program, and has established a consultative 
relationship with a social worker who is qualified under Sec.  
482.94(d)(1) of this paragraph.
     Revising proposed paragraph (e) by removing paragraphs 
(e)(1) and (e)(2), and now defining a qualified dietitian as an 
individual who meets practice requirements in the State in which he/she 
practices and who is a registered dietitian with the Commission on 
Dietetic Registration.
    Amend Sec.  482.96 ``Condition of participation: Quality assessment 
and performance improvement (QAPI)'' by--
     Adding in paragraph (a) the word ``requirements'' after 
the words ``OPTN waitlist (now waiting list)'' in order to further 
clarify this example of a QAPI program activity.
     Adding in paragraph (a) the words ``patient education'' to 
clarify that this is one of the included QAPI activities and outcomes.
    Amend Sec.  482.98 ``Condition of participation: Human resources'' 
by--
     Revising proposed paragraph (a)(1) to read: ``Coordinating 
with the hospital in which the transplant center is located to ensure 
adequate training of nursing staff and clinical transplant coordinators 
in the care of transplant patients and living donors' to further 
clarify the responsibilities of the Director of a transplant center.
     Revising paragraph (a)(3), to clarify that the director of 
the transplant center is responsible for ensuring that surgery is 
performed ``by, or under the direct supervision of, a qualified 
transplant surgeon.''
     Adding the phrase ``and who are immediately available to 
provide transplantation services when an organ is offered for 
transplantation'' at the end of the sentence at paragraph (b) to 
clarify that a transplant surgeon and physician must be immediately 
available to perform a transplant when an organ is offered.
     Removing in paragraph (c), the portion of the definition 
of a qualified clinical transplant coordinator, which requires an 
individual to be certified by the American Board of Transplant 
Coordinators, and adding in its place an expanded one that states ``The 
clinical transplant coordinator must be a registered nurse or other 
licensed clinician who has experience and knowledge of transplantation 
and living donation issues. The clinical transplant coordinator's 
responsibilities must include, but are not limited to, the following: 
(1) Ensuring the coordination of the clinical aspects of transplant 
patient and living donor care; and (2) Acting as a liaison between a 
kidney transplant center and dialysis facilities, as applicable.''
     Adding a new standard at paragraph (d) titled 
``Independent living donor advocate or living donor advocate team.'' 
This new requirement states ``The transplant center that performs 
living donor transplantation must identify either an independent living 
donor advocate or an independent living donor advocate team to ensure

[[Page 15251]]

protection of the rights of living donors and prospective living 
donors.'' As noted below, this new standard also has three new 
provisions contained within it.
     Requiring under the new paragraph (d)(1) that the living 
donor advocate or living donor advocate team must not be involved in 
transplantation activities on a routine basis.
     Requiring under the new paragraph (d)(2) that these 
independent advocates or advocate teams must demonstrate: (i) Knowledge 
of living organ donation, transplantation, medical ethics, and informed 
consent; and (ii) understanding of the potential impact of family and 
other external pressures on the prospective living donor's decision 
whether to donate and the ability to discuss these issues with the 
donor.
     Requiring under the new paragraph (d)(3) that the 
independent living donor advocate's or living donor advocate team's 
responsibilities include: (i) Representing and advising the donor; (ii) 
protecting and promoting the interests of the donor; and (iii) 
respecting the donor's decision and ensuring that the donor's decision 
is informed and free from coercion.
     Re-designating proposed Sec.  482.98 paragraph (d) as 
paragraph (e) with heading continuing to read ``Standard: Transplant 
team.'' All references to this paragraph have been amended accordingly.
     Re-designating proposed Sec.  482.98 paragraph (e) as 
paragraph (f) with heading continuing to read ``Standard: Resource 
commitment.'' All references to this paragraph have been amended 
accordingly.
     Adding the words ``patient education'' in newly re-
designated paragraph (f) to clarify that this is one of the areas of 
expertise that a transplant center is required to have available under 
its resources.
    Amend Sec.  482.100 ``Condition of Participation: Organ 
procurement'' by--
     Removing the paragraph designation ``(a)'' and combining 
the text with the condition statement.
     Re-designating proposed paragraph (b) as Sec.  
482.74(a)(3) and revising newly designated Sec.  482.74(a)(3) to read 
``Termination of an agreement between the hospital in which the 
transplant center is located and an OPO for the recovery and receipt of 
organs;''.
    Amend Sec.  482.102 ``Condition of participation: Patient and 
living donor rights'' by--
     Adding the words ``Patient rights'' to the condition 
statement to clarify that Sec.  482.13 is the Patients rights CoP.
     Revising proposed Sec.  482.102 paragraph (a) to read 
``Transplant centers must implement written transplant patient informed 
consent policies that inform each patient of: * * *''
     Amending paragraph (a)(5) to specify that information 
provided to patients includes (but is not limited to) information from 
the most recent SRTR center-specific report, including (but not limited 
to) the transplant center's observed and expected 1-year patient and 
graft survival, national 1-year patient and graft survival, and 
notification about all Medicare outcome requirements not being met by 
the transplant center.
     Removing the text of proposed paragraph (a)(6);
     Re-designating the proposed (a)(7) as (a)(6).
     Re-designating the proposed (a)(8) as (a)(7).
     Adding a new paragraph (a)(8) to read ``The fact that if 
his or her transplant is not provided in a Medicare-approved transplant 
center, it could affect the transplant recipient's ability to have his 
or her immunosuppressive drugs paid for under Medicare Part B.''
     Revising proposed Sec.  482.102 paragraph (b) to read 
``Transplant centers must implement written living donor informed 
consent policies that inform * * * .''
     Adding paragraph (b)(9) to read ``The fact that if a 
transplant is not provided in a Medicare-approved transplant center, it 
could affect the transplant recipient's ability to have his or her 
immunosuppressive drugs paid under Medicare Part B.''
     Deleting the phrase ``that meets the hospital's 
credentialing policies'' from proposed Sec.  482.102 paragraph 
(c)(1)(ii) in order to clarify this provision.
     Revising proposed Sec.  482.102 paragraph (c)(2)(ii) to 
read: ``Inform Medicare beneficiaries on the center's waiting list that 
Medicare will no longer pay for transplants performed at the center 
after the effective date of the center's termination of approval.''
     Adding a new provision at Sec.  482.102(c)(3) that reads 
``As soon as possible prior to a transplant center's voluntary 
inactivation, the center must inform patients on the center's waiting 
list and, as directed by the Secretary, provide assistance to waiting 
list patients who choose to transfer to the waiting list of another 
Medicare-approved transplant center without loss of time accrued on the 
waiting list.''
    Amend Sec.  482.104 ``Condition of participation: Additional 
requirements for kidney transplant centers'' by--
     Revising proposed Sec.  482.104 paragraph (a) by adding a 
new line that reads ``A kidney transplant center must have written 
policies and procedures for ongoing communications with dialysis 
patients' local dialysis facilities.''
     Removing the requirement at proposed Sec.  482.104 
paragraph (b) that kidney dialysis centers or units in kidney 
transplant centers providing dialysis services to inpatients directly 
or under arrangement must meet the Conditions of Coverage of Suppliers 
of ESRD Services contained in part 405 subpart U of this chapter. We 
are not finalizing this proposed requirement in the final rule.
    Amend Sec.  488.6 ``Other national accreditation programs for 
hospitals'' by--
     Revising paragraph (a), first sentence, by inserting the 
words ``transplant centers except for kidney transplant centers;'' 
after the words ``psychiatric hospitals;''.
    Amend Sec.  488.61 ``Special procedures for approval and re-
approval of organ transplant centers'' by--
     Revising the heading to paragraph (a) to read ``Initial 
approval procedures for transplant centers that are not Medicare-
approved as of June 28, 2007.''
     Revising paragraph (a) to clarify that a transplant 
center, including kidney transplant centers, may submit a request to 
CMS for Medicare approval at any time.
     Revising proposed Sec.  488.61 paragraph (a)(2) to include 
provisions from proposed paragraph (a)(3) to read ``To determine 
compliance with the clinical experience and outcome requirements at 
Sec.  482.80(b) and (c), CMS will review the data contained in the most 
recent OPTN Data Report and 1-year patient and graft survival data 
contained in the most recent Scientific Registry of Transplant 
Recipient (SRTR) center-specific report.''
     Deleting proposed paragraph (a)(3) and redesignating 
proposed paragraph (a)(4) as (a)(3). We revised proposed paragraph 
(a)(4), now (a)(3) to read: If CMS determines that a transplant center 
has not met the data submission, clinical experience, or outcome 
requirements, CMS may deny the request for approval or may review the 
center's compliance with the conditions of participation at Sec.  
482.72 through Sec.  482.76 and Sec.  482.90 through Sec.  482.104 of 
this chapter, using the procedures described at 42 CFR part 488, 
subpart A, to determine whether the center's request will be approved. 
CMS will notify the transplant center in writing whether it is approved 
and, if approved, of the effective date of its approval.
     Adding a new paragraph (a)(4) to describe mitigating 
factors CMS will consider in determining initial approval

[[Page 15252]]

or re-approval of a transplant center that does not meet the data 
submission, clinical experience, outcome requirements and other 
conditions of participation.
     Revising paragraph (a)(5) to outline the initial Medicare 
approval review process and approval period, and to specify how 
transplant centers will be notified of approval.
     Deleting proposed paragraph (a)(6) and including its 
content in proposed paragraph (a)(4) (now (a)(3)).
     Adding a new paragraph (a)(6) to state that a kidney 
center may submit a request for initial approval after performing at 
lease 3 transplants over a 12-month period.
     Revising proposed paragraph (a)(7) for clarity.
    All references to these paragraphs have been amended accordingly.
     Redesignating proposed paragraph (b) as paragraph (c).
     Adding a new paragraph (b) to clarify that all transplant 
centers, including kidney transplant centers, approved as of the 
effective date of this final rule that want to continue to be Medicare 
approved must submit a request to CMS for Medicare approval under the 
conditions of participation by December 26, 2007, using the process 
described in paragraph (a)(1) of the section. CMS will determine 
whether to approve a transplant center using the procedures described 
in paragraphs (a)(2) through (a)(5) of the section.
     Revising proposed paragraph (b) (now (c)), for clarity.
     Revising proposed Sec.  488.61 paragraph (b)(1)(ii) (now 
(c)(1)(ii)) to read ``To determine compliance with the clinical 
experience and outcome requirements at Sec.  482.82(b) and (c), CMS 
will review the data contained in the most recent OPTN Data Report and 
1-year patient and graft survival data contained in the most recent 
Scientific Registry of Transplant Recipient (SRTR) center-specific 
report.''
     Revising proposed 488.61 paragraph (b)(4) (now (c)(1)) to 
read ``Prior to the end of the 3-year approval period, CMS will review 
the transplant center's data in making re-approval determinations.''
     Adding a new paragraph (c)(4) to describe mitigating 
factors CMS will consider in determining re-approval of a transplant 
center that does not meet the data submission, clinical experience, 
outcome requirements and other conditions of participation.
     Revising proposed Sec.  488.61 paragraph (b)(4) (now 
(c)(5)) to read: ``CMS will notify the transplant center in writing if 
its approval is being revoked and of the effective date of the 
revocation.''
     Adding the phrase ``including kidney transplant centers'' 
to paragraph (c) to clarify that all transplant centers must be in 
compliance with all the CoPs for transplant center at Sec.  482.72 
through Sec.  482.104, except for Sec.  482.80 (Initial approval 
requirements) throughout the 3 year approval period.
     Adding a new transplant center inactivity requirement at 
paragraph (e) to state that a transplant center may inactivate its 
program for a period not to exceed 12 months during the 3-year approval 
cycle. A transplant center must notify CMS upon its voluntary 
inactivation as required by Sec.  482.74(a)(4).

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act (PRA) 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 PRA of 1995 requires that 
we solicit comments 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 solicited public comments on each of these issues for the 
sections of this document that contain information collection 
requirements (ICRs).

General Comments

    Comment: Some commenters said they were concerned that CMS 
generally underestimated the total burden hours and/or total estimated 
costs that this regulation would impose on transplant centers. Other 
commenters felt that some of the data used in the proposed rule were 
inaccurate.
    Response: After further analysis of the tasks needed for the 
paperwork requirements in this final rule and review of more recent 
financial data, we agree with the commenters that for certain 
requirements, we underestimated the total burden hours (and in the 
economic impact analysis, the total estimated costs) associated with 
the paperwork requirements in the proposed rule. Therefore, we have 
increased our estimate of total burden hours and/or total costs for 
some of the conditions of participation. These changes are discussed 
below for each relevant condition of participation.
    Comment: Some commenters said that many of the requirements in the 
proposed rule would be unnecessary because some of the proposed 
requirements are similar or identical to either current OPTN or JCAHO 
requirements.
    Response: The commenters are correct; however, we disagree that 
these requirements are unnecessary. For these requirements to be 
enforceable by us through our oversight and survey and certification 
process, they must be promulgated as regulations.
    Also, some commenters stated that the regulation would increase 
post-transplant health care costs. However, this final rule regulates 
only inpatient transplant services and will not increase the cost of 
providing post-transplant care once patients are discharged from the 
hospital.

Section 482.74 Condition of Participation: Notification to CMS

    Section 482.74 requires a transplant center to notify us 
immediately of any significant changes related to the center's 
transplant program or changes that could affect its compliance with the 
CoPs. The instances in which a transplant center must notify us 
include, but are not limited to: any change in key staff members of the 
transplant team; a decrease in the number of the center's transplants 
or survival rates that could result in the center being out of 
compliance with Sec.  482.82, Condition of participation: Data 
submission, clinical experience, and outcome requirements for re-
approval of transplant centers; termination of an agreement between the 
hospital in which the transplant center is located and an OPO for the 
recovery and receipt of organs; and inactivation of the transplant 
center.
    In the proposed rule, we estimated that the burden associated with 
this section would be the time required to notify us of significant 
changes. We estimated that there would be three occasions annually per 
center requiring notification. For each occasion, we estimated that it 
would take 5 minutes to notify us. Therefore, we estimated that it 
would take no more than 15 minutes annually for each center to notify 
us of any significant changes. We said that since there were 
approximately 900 transplant centers, we estimated that the total 
burden hours for

[[Page 15253]]

complying with this section would be a total of 225 hours. The estimate 
of 900 transplant centers included non-Medicare approved transplant 
centers. However, our analysis will only concern Medicare-approved 
centers.
    Comment: One commenter said that we significantly underestimated 
the burden required for transplant centers to comply with this 
requirement. The commenter noted that notifying us of these changes 
required the involvement of the program's medical director, an 
administrator, and appropriate clerical/support staff. The commenter 
opined that large centers would have a significant number of changes 
per year, perhaps as many as 6-12, and that each change would require 
15-30 minutes of time for each of the individuals involved or 
approximately one and one-half to two hours per change.
    Response: We agree that we underestimated the burden of this 
requirement. We agree that reporting a significant change to us would 
require more than 5 minutes and would involve senior staff and 
management. After further analysis of the tasks involved in complying 
with this section and the personnel that generally would be involved.

       Total Annual Burden Hours and Total Annual Cost Estimate for Submitting Significant Changes to CMS
----------------------------------------------------------------------------------------------------------------
                                                                                                   Total annual
                                                                                   Total annual    cost estimate
                                                  Hours required    Total cost     burden hours     per center
            Position                Hourly wage     per report     estimate for     per center    (for 3 reports
                                                                    each report       (for 3       per year per
                                                                                     reports)         center)
----------------------------------------------------------------------------------------------------------------
Medical Director................         $116.60             .50          $58.30            1.5          $174.90
Senior Administrator............           92.31             .50           46.16            1.5           138.46
Transplant Coordinator..........           43.87             .75           32.90            2.25           98.71
Secretary.......................           21.81             .25            5.45             .75           16.36
                                 -------------------------------------------------------------------------------
    Totals......................  ..............            2.00          142.81            6.0           428.43
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com.

Section 482.76 Condition of Participation: Pediatric Transplants

    Section 482.76 states that a transplant center that seeks Medicare 
approval to provide transplantation services to pediatric patients must 
submit to CMS a request specifically for Medicare approval to perform 
pediatric transplants using the procedures at Sec.  488.61, Special 
procedures for approval and re-approval of organ transplant centers. 
The center requesting Medicare approval to perform pediatric 
transplants must meet all the conditions of participation in Sec. Sec.  
482.72 through 482.74 and Sec. Sec.  482.80 through 482.104, with 
respect to its pediatric patients.
    The burden associated with this requirement would be the time 
required to prepare and submit the required information and data to us. 
Since pediatric centers must comply with the procedures at Sec.  
488.61, the burden for pediatric centers to request Medicare approval 
will be analyzed under that section.
    In lieu of meeting all of the requirements in those sections noted 
above, Sec.  482.76(d) provides that a heart transplant center that 
wishes to provide transplantation services to pediatric heart patients 
may be approved to perform pediatric heart transplant by meeting the 
OBRA 1987 criteria in section 4009(b) (Pub. L. 100-203) as follows:
    (1) The center's pediatric transplant program must be operated 
jointly by the hospital and another facility that is Medicare-approved;
    (2) The unified program shares the same transplant surgeons and 
quality improvement program (including oversight committee, patient 
protocol, and patient selection criteria); and
    (3) The center must demonstrate to the satisfaction of the 
Secretary that it is able to provide specialized facilities, services, 
and personnel that are required by pediatric heart transplant patients.
    The burden associated with this requirement is the time required 
for heart transplant centers that choose to use the alternative 
criteria under Sec.  482.76(d) to prepare and submit the required 
information to us. We believe that it would require additional time to 
apply using the alternative criteria in this section. However, we also 
believe that the additional burden would be minimal.
    In addition, we believe that fewer than 10 entities would choose to 
apply for Medicare approval using the alternative criteria in this 
section in any given year. There are currently seven Medicare-approved 
pediatric heart transplant centers. Even if we should receive requests 
for Medicare approval from the equivalent of 50 percent of the 
currently approved centers, we would receive only about 4 requests. 
Under 5 CFR 1320.3(c), a ``collection of information'' does not include 
requirements imposed on fewer than ten entities. Therefore, the 
requirements under Sec.  482.76(d) are not subject to the PRA.

Section 482.80 Condition of Participation: Data Submission, Clinical 
Experience, and Outcome Measure Requirements for Initial Approval of 
Transplant Centers

    Section 482.80 requires that, except as specified in paragraph (d) 
of that section and at 488.61, transplant centers must generally meet 
all data submission, clinical experience, and outcome requirements to 
be granted initial approval by us. Section 482.80(a) requires 
transplant centers to submit to the OPTN at least 95 percent of the 
required data on all transplants (deceased and living donors) no later 
than 90 days after the date established by the OPTN. The required data 
submissions include, but are not limited to, submission of the 
appropriate OPTN forms for transplant candidate registration, 
transplant recipient registration and follow-up, and living donor 
registration and follow-up.
    The burden associated with this requirement is the amount of time 
it would take the transplant center to submit the required data. In the 
proposed rule, we stated that we believed that these requirements 
reflected usual and customary business practice and would be followed 
even if there were no Medicare requirements. Thus, we said that the 
burden for these requirements would be exempt under 5 CFR 1320.3(b)(2).
    Comment: A national organization that represents professionals in 
the transplant community commented that the data submission 
requirements

[[Page 15254]]

necessary for OPTN compliance have had a huge financial impact on 
transplant centers. The commenter noted that multiple forms are 
required for each patient, from the time of registration on the OPTN 
waiting list to several years post-transplant. They noted that the 
analysis did not account for the additional resources needed to 
complete and submit these forms.
    Response: Although we appreciate that the data submission 
requirements necessitate significant resources from the transplant 
centers, we would point out that OPTN policies require transplant 
hospitals as a condition of membership to submit these required data to 
the OPTN. The final rule governing the operation of the OPTN (42 CFR 
121.11) also imposes this requirement by Federal regulation. Further, 
existing Medicare regulations require that if a hospital performs 
transplants, it must be a member of the OPTN and provide organ-
transplant-related data, as requested, to the OPTN, SRTR, and the OPOs. 
(See 42 CFR 482.45(b).) Therefore, complying with this section imposes 
little additional burden on the transplant centers and constitutes 
usual and customary business practice.
    Under 5 CFR 1320.3(b)(2), if the activities that are needed to 
comply with an ICR constitute usual and customary business practices, 
those activities should be excluded from the burden analysis. Thus, 
these activities will not be included in the burden analysis for this 
final rule.

Section 482.82 Condition of Participation: Data Submission, Clinical 
Experience, and Outcome Measure Requirements for Re-Approval of 
Transplant Centers

    Section 482.82 provides that, except as specified in paragraph (d) 
of this section and at 488.61, transplant centers must meet all the 
data submission, clinical experience, and outcome requirements to be 
re-approved. Section 482.82(a) requires that no later than 90 days 
after the due date established by the OPTN, a transplant center must 
submit to the OPTN at least 95 percent of the required data submissions 
on all transplants (deceased and living donors) it has performed over 
the 3-year approval period. The required data submissions include, but 
are not limited to, submission of the appropriate OPTN forms for 
transplant candidate registration, transplant recipient registration 
and follow up, and living donor registration and follow up.
    The burden associated with this requirement is the time it would 
take the transplant center to submit the required data. As discussed 
above under Sec.  482.80, we already require hospitals in which 
transplant centers are located to belong to the OPTN, and the OPTN 
requires that these hospitals submit data to the OPTN. (See Sec.  
482.45(b).)
    Thus, complying with this section imposes little additional burden 
on the transplant centers and constitutes usual and customary business 
practice. Under 5 CFR 1320.3(b)(2), if the activities that are needed 
to comply with an ICR constitute usual and customary business 
practices, those activities should be excluded from the burden 
analysis. Therefore, these activities will not be included in this 
final rule's burden analysis.

Section 482.90 Condition of Participation: Patient and Living Donor 
Selection

    Section 482.90 requires transplant centers to use written patient 
selection criteria in determining a patient's suitability for placement 
on the waiting list or a patient's suitability for transplant. If a 
center performs living donor transplants, the center must also use 
written donor selection criteria in determining the suitability of 
candidates for donation.
    Section 482.90(a) states that before a transplant center places a 
transplant candidate on its waiting list, the candidate's medical 
record must contain documentation that the candidate's blood type has 
been determined. When a patient is placed on a center's waiting list or 
is selected to receive a transplant, the center must document in the 
patient's medical record the patient selection criteria that were used. 
Section 482.90(b) states that a transplant center also must document in 
the living donor's medical records the living donor's suitability for 
donation and that the living donor has given informed consent, as 
required under Sec.  482.102(b).
    Comment: Some commenters said that the patient selection criteria 
requirements would be burdensome. For example, one commenter said that 
it would take at least 30 minutes of staff time to document the patient 
selection criteria in the file of each patient or living donor.
    Response: We disagree. Each center has the flexibility to determine 
the most expedient way to satisfy this requirement. Centers should be 
able to reduce the resources needed to document individual potential 
transplant recipient and living donor medical records significantly by 
using electronic formats, forms, or checklists. Therefore, complying 
with this requirement constitutes a minimal burden to the transplant 
centers.
    Comment: One commenter said that we did not address the 
recordkeeping burden for this requirement.
    Response: For the reasons discussed immediately below, we do not 
believe a burden analysis of this requirement should be included in 
this PRA analysis.
    The burden associated with complying with this section is the time 
to develop the transplant recipient and living donor selection criteria 
and document each potential transplant recipient's and living donor's 
medical record. We expect that all transplant centers have policies 
regarding selection criteria for potential transplant recipients and 
living donors (if they perform living donor transplants). In addition, 
it is standard medical practice to document in the medical record of a 
hospital patient undergoing surgery whether the patient meets the 
hospital's criteria for surgery. Thus, we believe that the activities 
required by this section constitute usual and customary business 
practices for transplant centers. Therefore, pursuant to 5 CFR 
1320.3(b)(2), we will not include these activities in the burden 
analysis for this final rule.

Section 482.92 Condition of Participation: Organ Recovery and Receipt

    Transplant centers must have written protocols to validate donor-
recipient matching of blood types and other vital data for deceased 
organ recovery, organ receipt, and living donor transplantation 
process.
    The burden associated with this section is the time required to 
develop these written protocols. We believe that developing written 
protocols for critical functions such as those required by this section 
reflect usual and customary business practice for transplant centers. 
Therefore, the burden of these requirements is exempt under 5 CFR 
1320.3(b)(2).

Section 482.94 Condition of Participation: Patient and Living Donor 
Management

    Transplant centers must have written patient management policies 
for the transplant and discharge phases of transplantation. If a 
transplant center performs living donor transplants, the center also 
must have written donor management policies for the donor evaluation, 
donation, and discharge phases of living organ donation.
    The burden associated with these requirements is the time it takes 
to develop written patient management policies. We believe that it is 
usual and customary business practice for

[[Page 15255]]

transplant centers, as it would be for any major health care facility, 
to have written patient management policies. Thus, under 5 CFR 
1320.3(b)(2), these activities should be excluded from any burden 
analysis.
    In addition, Sec.  482.94(b) requires that transplant centers must 
keep their waiting lists up to date on an ongoing basis, including:
    (1) Updating of waiting list patients' clinical information;
    (2) Removing patients from the center's waiting list if a patient 
receives a transplant or dies, or if there is any other reason that the 
patient should no longer be on a center's waiting list; and
    (3) Notifying the OPTN no later than 24 hours after a patient's 
removal from the center's waiting list.
    Section 482.94(c) requires transplant centers to maintain up-to-
date and accurate patient management records for each patient who 
receives an evaluation for placement on a center's waiting list and who 
is admitted for organ transplantation.
    Section 482.94(c)(1) states that for each patient who receives an 
evaluation for placement on a center's waiting list, the center must 
document in the patient's record that the patient (and in the case of a 
kidney patient, the patient's usual dialysis facility) has been 
informed of his or her transplant status, including notification of: 
(i) The patient's placement on the center's waiting list; (ii) The 
center's decision not to place the patient on its waiting list; or 
(iii) The center's inability to make a determination regarding the 
patient's placement on its waiting list because further clinical 
testing or documentation is needed.
    Section 482.94(c)(2) states that if a patient on the waiting list 
is removed from the waiting list for any reason other than death or 
transplantation, the transplant center must document in the patient's 
record that the patient (and in the case of a kidney patient, the 
patient's usual dialysis facility) was notified of his or her removal 
from the waiting list no later than 10 days after the date the patient 
was removed from the center's waiting list.
    Section 482.94(c)(3) states that in the case of patients admitted 
for organ transplants, transplant centers must maintain written records 
of multidisciplinary patient care planning during the transplant period 
and multidisciplinary discharge planning for post-transplant care.
    The burden associated with this section, except for notifying 
dialysis facilities, is the time required for a transplant center to 
document all the necessary information and maintain the waiting list. 
As described above, all transplant centers must already follow OPTN 
requirements for notification of patients and maintenance of their 
waiting lists. We believe that most, if not all, transplant centers 
have business practices that already comply with this section. For the 
remainder of centers, compliance should require only a minimal burden.
    Under 5 CFR 1320.3(b)(2), if the activities that are needed to 
comply with an ICR constitute usual and customary business practices, 
those activities should be excluded from the burden analysis. Since the 
activities that are required to satisfy this section constitute usual 
and customary business practices, the burden associated with them will 
not be included in our PRA analysis for this final rule.
    Section 482.94(c)(1) and (2) require kidney transplant centers, in 
the case of dialysis patients, to document in the patient's record that 
both the patient and the patient's usual dialysis facility have been 
notified of the patient's transplant status and all changes in the 
patient's transplant status as required under Sec.  482.94(c)(1). Since 
this is not a requirement for OPTN members, we do not believe that all 
kidney transplant centers are currently notifying dialysis facilities.
    The burden associated with this requirement is the time it would 
take for the transplant center to notify the various dialysis 
facilities of the status of their patients on the transplant center's 
waiting list. Rather than notifying dialysis facilities on an 
individual basis, we believe that transplant centers would chose to 
periodically notify the dialysis centers about their patients' status. 
Thus, for the purposes of determining the burden for this requirement, 
we will assume quarterly notifications by the transplant centers to the 
dialysis facilities. Note that this final rule does not establish a 
time frame transplant centers must use to notify dialysis centers about 
patient status. We are using quarterly notification only to estimate an 
economic impact for this notification requirement.
    According to UNOS, as of December 31, 2005, there were 64,848 
individuals awaiting kidney transplants. Currently, there are 
approximately 4,649 dialysis facilities and approximately 243 Medicare-
approved kidney transplant centers. Therefore, the average transplant 
center will have to notify 19 dialysis clinics about the waiting list 
status of their patients (4,649 dialysis facilities divided by 243 
Medicare-approved kidney transplant centers = 19.13 dialysis centers). 
Since there are 64,848 patients waiting for kidney transplants and 
4,649 dialysis facilities, there are an average of 14 patients on the 
waiting list for kidneys at each dialysis facility (64,848 patients 
divided by 4,649 dialysis facilities = 13.9). Thus, for each of the 243 
kidney transplant centers, there are about 267 waiting list patients 
(64,848 patients divided by 243 transplant centers = 266.86 or 14 
patients per dialysis facility x 19 dialysis facilities = 266). 
Therefore, on average, each transplant center would have to determine 
the status of about 267 patients and notify an average of 19 dialysis 
facilities about the status of these patients 4 times a year.
    Based upon our past experience, we believe that this notification 
would require the involvement of the transplant coordinator and 
appropriate support/clerical staff. We would anticipate that the 
transplant centers would utilize modern technology to minimize the 
burden of satisfying this requirement.

[[Page 15256]]



    Total Annual Burden Hours and Total Annual Cost Estimate To Notify Dialysis Facilities of Their Patients'
                                               Waiting List Status
----------------------------------------------------------------------------------------------------------------
                                                                                   Total annual    Total annual
            Position                Hourly wage    Burden hours    Cost estimate  hours required   cost estimate
                                                    per event*      per event*    (for 4 events)  (for 4 events)
----------------------------------------------------------------------------------------------------------------
Transplant Coordinator..........         $ 43.87            2.00          $87.74             8.0         $350.96
Secretary.......................           21.81             .50           10.90             2.0           43.62
                                 -------------------------------------------------------------------------------
    Totals......................  ..............            2.50           98.64            10.0          394.58
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com.
*Each notification is an ``event.''

    Thus, we anticipate that the burden hours for each time a 
transplant center notifies the relevant dialysis centers of the status 
of their patients on the center's waiting list would require 2.5 burden 
hours and the cost estimate would be $98.64. With the transplant 
centers conducting these notifications on a quarterly basis, that is, 4 
notifications per year for each kidney center, the total annual burden 
hours for each center would be 10 and the total annual cost estimate 
would be $394.58. Since there are currently 243 current Medicare-
approved kidney transplant centers, their total burden hours would be 
2,430 (243 centers x 10 hours = 2,430) and the total cost complying 
with this ICR is $95,882.94 (243 centers x $394.58 = $95,882.94).

Section 482.96 Condition of participation: Quality assessment and 
performance improvement (QAPI)

    Section 482.96 requires transplant centers to develop, implement, 
and maintain a written, comprehensive, data-driven QAPI program 
designed to monitor and evaluate performance of all transplantation 
services, including services provided under contract or arrangement.
    Section 482.96(b) requires transplant centers to establish and 
implement written policies to address and document adverse events that 
occur during any phase of an organ transplantation case. These policies 
must address, at a minimum, the process for the identification, 
reporting, analysis, and prevention of adverse events. When an adverse 
event is identified, the transplant center must conduct a thorough 
analysis of and document any adverse event.
    The burden associated with this rule is the time required to 
develop these policies and document each adverse event. In the proposed 
rule, we estimated that it would take 8 hours on a 1-time basis to 
comply with this requirement.
    Comment: Some commenters disagreed with our analysis and said that 
we underestimated the time and staff hours required to comply with this 
section. One commenter stated that a large center would require one 
full-time equivalent (FTE) to comply with this requirement. Another 
commenter indicated that it took 160 staff hours to develop and 
establish the QAPI program at his or her hospital and 1.25 FTEs to 
maintain the program. This commenter indicated that eight hours would 
only be a ``start'' in complying with this requirement.
    Response: We agree with the commenters that 8 hours is insufficient 
to develop the policies necessary to comply with this section. However, 
since all transplant centers are located in Medicare hospitals and 
Medicare hospitals are required to have a QAPI program (see 42 CFR 
482.21), we believe that each center will have sufficient resources 
available to develop its own QAPI program in considerably fewer than 
160 burden hours.
    We believe that the typical transplant center would already have 
established a QAPI program as part of its usual and customary business 
practices and, thus, would not incur any additional associated burden. 
Therefore, since the activities required to comply with this section 
constitute usual and customary business practices, any burden 
associated with this requirement is exempt from the burden analysis 
under 5 CFR 1320.3(b)(2).

Section 482.98 Condition of Participation: Human Resources

    Section 482.98(b) requires transplant centers to identify to the 
OPTN a primary transplant surgeon and a transplant physician with the 
appropriate training and experience to provide transplantation services 
who are immediately available to provide transplantation services when 
an organ is offered for transplantation.
    The burden associated with this requirement is the time it will 
take to compile this information and forward it to the OPTN. Since this 
same information is required for the letter requesting initial approval 
for the transplant center at Sec.  488.61(a), each transplant center 
will only need to notify the OPTN of the two individuals it has 
designed as its primary transplant surgeon and transplant physician. 
This could be done electronically or by a simple form, depending upon 
OPTN requirements. Thus, notifying the OPTN of the same information 
should not result in any additional appreciable burden to the 
transplant centers.

Section 482.100 Condition of Participation: Organ Procurement

    Section 482.100 requires a transplant center to ensure that the 
hospital in which it operates has a written agreement for the receipt 
of organs with an OPO designated by the Secretary that identifies 
specific responsibilities for the hospital and for the OPO with respect 
to organ recovery and organ allocation.
    The burden associated with this rule is the time required to draft 
a mutually acceptable agreement between the transplant center and the 
designated OPO for the receipt of organs. Section 121.9 of the 
Department's regulations governing the OPTN requires transplant centers 
to have letters of agreement or contracts with an OPO. However, such a 
letter of agreement or contract will not satisfy the requirements of 
this section if it does not identify specific responsibilities for the 
hospital and the OPO with respect to organ recovery and organ 
allocation. Thus, we believe that approximately 50 percent, or 252, 
transplant centers will need to re-draft the letters of agreement or 
contracts between themselves and their designated OPOs that identify 
specific responsibilities for the hospital and for the OPO with respect 
to organ recovery and organ allocation.
    Based upon our experience with transplant centers, as well as other 
health care organizations, agreements of this type would require the 
involvement of the transplant center's attorney, medical director, 
administrator, transplant coordinator, and appropriate clerical/support 
staff. We believe that it would require a total of approximately

[[Page 15257]]

11 hours to negotiate and draft a mutually acceptable agreement that 
would be signed by both the transplant center and OPO.

Total Annual Burden Hours and Total Annual Cost Estimate To Develop an Agreement Between a Transplant Center and
                              an OPO Concerning Organ Recovery and Organ Allocation
----------------------------------------------------------------------------------------------------------------
                                                                                   Total annual    Total annual
                            Position                                Hourly wage   hours required   cost estimate
----------------------------------------------------------------------------------------------------------------
General Counsel or Attorney.....................................         $176.86             4.0         $707.44
Medical Director................................................          116.60             2.0          233.20
Senior Administrator............................................           92.31             2.0          184.62
Transplant Coordinator..........................................           43.87             2.0           87.74
Secretary.......................................................           21.81             1.0           21.81
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
    Totals......................................................  ..............           11.00       1,234.81
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com.

    Thus, for each transplant center to negotiate and draft an 
agreement with its designated OPO concerning organ recovery and organ 
allocation, the total annual burden hours would be 11 and the total 
cost estimate would be $1,234.81. For 252 transplant centers to 
negotiate and draft these agreements, the total burden hours would be 
2772 (11 annual burden hours x 252 transplant centers = 2,268) and the 
total cost estimate would be $311.172.12 (252 transplant centers x 
$1,073.30).

Section 482.102 Condition of Participation: Patient and Living Donor 
Rights

    Section 482.102 requires transplant centers to implement written 
transplant patient informed consent policies. The policies must inform 
each patient of: (1) The evaluation process; (2) the surgical 
procedure; (3) alternative treatments; (4) potential medical or 
psychosocial risks; (5) national and transplant center-specific 
outcomes; (6) organ donor risk factors that could affect the success of 
the graft or the health of the patient, including, but not limited to, 
the donor's history, condition or age of the organs used, or the 
patient's potential risk of contracting the human immunodeficiency 
virus and other infectious diseases if the disease cannot be detected 
in an infected donor; (7) his or her right to refuse transplantation; 
and (8) the fact that if his or her transplant is not provided in a 
Medicare-approved transplant center, it could affect the transplant 
recipient's ability to have his or her immunosuppressive drugs paid 
under Medicare Part B.
    Section 482.102(b) also requires transplant centers to implement 
written living donor informed consent policies that inform the 
prospective living donor of all aspects of, and potential outcomes 
from, living donation. Each transplant center must ensure that the 
prospective living donor is fully informed about the following: (1) The 
fact that communication between the donor and the transplant center 
will remain confidential; (2) the evaluation process; (3) the surgical 
procedure, including post-operative treatment; (4) the availability of 
alternative treatments for the transplant recipient; (5) the potential 
medical or psychosocial risk to the donor; (6) the national and 
transplant center-specific outcomes for recipients; and national and 
center-specific outcomes for living donors, as data are available; (7) 
the possibility that future health problems related to the donation may 
not be covered by the donor's insurance and that the donor's ability to 
obtain health, disability, or life insurance may be affected; (8) the 
donor's right to opt out of donation at any time during the donation 
process; and (9) the fact that if a transplant is not provided in a 
Medicare-approved transplant center, it could affect the transplant 
recipient's ability to have his or her immunosuppressive drugs paid 
under Medicare Part B.
    We expect that nearly all transplant centers currently have written 
policies regarding informed consent. Therefore, there would be no 
additional burden on them, as these policies are usual and customary 
business practices. Therefore, the burden of these requirements is 
exempt under 5 CFR 1320.3(b)(2) and will not be included in our PRA 
analysis for this final rule.
    Section 482.102(c) requires each transplant center to notify 
patients placed on its waiting list of information about the center 
that could impact the patient's ability to receive a transplant should 
an organ become available, and what procedures are in place to ensure 
the availability of a transplant team. Section 482.102(c)(1) 
specifically requires a transplant center served by a single transplant 
surgeon or physician to inform patients placed on the center's waiting 
list of the potential unavailability of the transplant surgeon or 
physician and whether the center has a mechanism to provide an 
alternative transplant surgeon or transplant physician.
    Comment: One commenter pointed out that complying with this 
requirement would entail the drafting of a letter by an administrator, 
approval by the surgeon, searching a database to identify appropriate 
patients, clerical or support resources to prepare and mail the 
letters, and the expense associated with actually mailing the letters. 
The commenter pointed out that this would be an extensive and 
unrealistic use of resources for short-term unavailability issues, such 
as the absence of the transplant surgeon.
    Response: As discussed earlier in this preamble, this provision 
does not require transplant centers to inform waiting list patients on 
an ongoing basis about the short-term unavailability of a transplant 
surgeon, for example, when a transplant surgeon is on vacation. The 
provision simply requires that, at the time a patient is placed on the 
waiting list, the patient is informed about circumstances that could 
impact the patient's ability to receive a transplant should an organ 
become available and what procedures the transplant center has in place 
to address these circumstances. Clearly, this requirement is 
particularly important when a transplant center is served by a single 
transplant surgeon or transplant physician. We expect that most 
transplant centers already provide this information to patients when 
they are placed on the waiting list.
    Therefore, the burden associated with this requirement is exempt 
under 5 CFR 1320.3(b)(2). The burden of these activities will not be 
included in our PRA analysis for this final rule.
    Section 482.102(c)(2) states that at least 30 days before a 
transplant center's Medicare approval is terminated, whether 
voluntarily or involuntarily,

[[Page 15258]]

the center must inform patients on the center's waiting list of this 
fact and provide assistance to waiting list patients who choose to 
transfer to the waiting list of another Medicare-approved transplant 
center without loss of time accrued on the waiting list. The transplant 
center must also inform Medicare beneficiaries on the center's waiting 
list that Medicare will no longer pay for transplants performed at the 
center after the effective date of the center's loss of Medicare 
approval at least 30 days before their Medicare approval is terminated. 
In addition, Sec.  482.102(c)(3) requires that as soon as possible 
prior to a transplant center's voluntary inactivation, the center must 
inform patients on the center's waiting list and, as directed by the 
Secretary, provide assistance to waiting list patients who choose to 
transfer to the waiting list of another Medicare-approved transplant 
center without the loss of time accrued on the waiting list.
    The burden associated with this section would be the time required 
of a transplant center to draft a letter notifying patients on its 
waiting list of the loss of the program's Medicare approval status and, 
by mail or otherwise, provide the letter to all patients on the 
center's waiting list. We estimate that it would require an 
administrator approximately 30 minutes to draft the letter. It would 
then require a secretary or other support staff person 2.5 hours to 
copy and/or mail these letters to the individuals on the center's 
waiting list(s). Based on our estimate, complying with this section 
would require three burden hours and the total cost would be $100.69.

  Total Burden Hours and Total Cost Estimate for Notifying Patients on a Center's Waiting List of a Transplant
                                       Center's Loss of Medicare Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Senior Administrator............................................          $92.31             .50          $46.16
Secretary.......................................................           21.81            2.50           54.53
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
    Totals......................................................  ..............            3.00         100.69
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com.

    As discussed in more detail below under section Sec.  488.61, we 
believe that, based upon the requirements contained in this final rule, 
up to two percent of transplant centers or approximately 10 centers may 
lose their Medicare-approved status annually. If 10 centers annually 
lost their Medicare-approved status, either voluntarily or 
involuntarily, then the total annual burden hours would be 30 (10 
transplant centers x 3 burden hours = 30 total burden hours) and the 
total annual cost estimate would be $1,006.90 ($100.69 cost estimate x 
10 transplant centers = $1,006.90).

Section 482.104 Condition of Participation: Additional Requirements for 
Kidney Transplant Services

    Section 482.104(a) states that a kidney transplant center must have 
written policies and procedures for ongoing communications with 
dialysis patients' local dialysis facilities.
    The burden associated with this requirement is the time and effort 
it would take for a kidney transplant center to develop the written 
policies and procedures for such communication. Under this final rule, 
one of the responsibilities of the clinical transplant coordinator is 
to act as a liaison between a kidney transplant center and dialysis 
facilities. (See Sec.  482.98(c)(2).) We believe that most centers 
currently use their clinical transport coordinators in this role. Most 
centers will be able to meet this requirement by putting their current 
practice into writing. This will probably be done by the clinical 
transplant coordinators. Since they are memorializing their current 
practices, we believe it can be accomplished in a very short time. We 
believe that this communication policy and procedures will be 
straightforward and can be accomplished quickly by the coordinators. In 
addition, many centers may already have such policies and procedures in 
writing. Thus, complying with this requirement will constitute a 
minimal burden to the centers.

Section 488.61 Special Procedures for Approval And Re-Approval of Organ 
Transplant Centers

    Section 488.61(a) requires transplant centers that are not 
Medicare-approved as of June 28, 2007 to submit a request to CMS for 
Medicare approval. Section 488.61(b) requires transplant centers, 
including kidney transplant centers, that are Medicare approved as of 
June 28, 2007 to submit a request for Medicare approval no later than 
December 26, 2007. The process for making the request for Medicare 
approval is the same for both types of transplant centers. (See Sec.  
488.61(b)(1).) The request for Medicare approval must be signed by a 
person authorized to represent the center (for example, a chief 
executive officer). The request must include the hospital's Medicare 
provider identification (I.D.) number; the name(s) of the designated 
primary transplant surgeon and primary transplant physician; and a 
statement from the OPTN that the center has complied with all data 
submission requirements.
    The burden associated with this section would be the time required 
to prepare and submit this letter to us. In addition, the center would 
have to obtain a statement from the OPTN that the center had complied 
with all data submission requirements to submit with the letter.
    In the proposed rule, we estimated that each hospital would spend 
approximately 15 minutes to prepare and submit the letter requesting 
Medicare approval to us. We did note that a hospital may have multiple 
transplant centers and, therefore, could be submitting more than one 
request for approval.
    Comment: We received public comments on the proposed rule that said 
we had underestimated the time required for a transplant center to 
apply for Medicare approval. One commenter emphasized that 
transplantation centers take applying for Medicare approval very 
seriously. The commenter also indicated that the preparation, approval, 
and submission of the request for Medicare approval could take days at 
many large institutions.
    Response: After further analysis of the tasks and the personnel 
that would be involved in applying for Medicare approval, we agree with 
the commenters that 15 minutes significantly underestimates the time 
required to prepare, obtain the required center approval(s), obtain the 
statement from

[[Page 15259]]

the OPTN, and submit the request for Medicare approval to us. However, 
we disagree with the commenter that said it could take ``days'' to 
accomplish all of the required tasks. Our analysis of the total burden 
hours and total cost estimate are discussed in detail below.
    We now believe that accomplishing all of the tasks necessary for 
complying with Sec.  488.61(a) would involve the transplant program's 
medical director, an administrator, a transplant coordinator, and 
appropriate support/administrative staff. We estimate that it would 
take these individuals approximately the same amount of time as it 
would take the transplant center to notify us of a significant change 
in their program or approximately 2 burden hours.

     Total Annual Burden Hours and Total Annual Cost for a Transplant Center To Apply for Medicare Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................         $116.60             .50          $58.30
Senior Administrator............................................           92.31             .50           46.16
Transplant Coordinator..........................................           43.87             .75           32.90
Secretary.......................................................           21.81             .25            5.45
                                                                 -----------------------------------------------
    Totals......................................................  ..............            2.00          142.81
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site athttp://hrsalarycenter.salary.com.

    This final rule requires all transplant centers that are currently 
Medicare-approved to apply for initial approval under the requirements 
in this final rule. There are currently approximately 504 Medicare-
approved transplant centers. We believe that all 504 transplant centers 
will submit requests to us to retain their Medicare approval. In 
addition, based on our previous experience, we believe that 
approximately 10 new centers a year may apply for Medicare approval. 
Thus, we anticipate 514 transplant centers will be applying for 
Medicare approval of their transplant programs in the first year 
following the effective date of this final rule.
    For the first year after the effective date of this final rule, the 
total burden hours would be 1,028 (514 transplant centers x 2 burden 
hours = 1,028 total burden hours), and the total cost estimate would be 
$73,404.34 (514 transplant centers x $142.81 = $73,404.34). For 
subsequent years, we anticipate that about 10 transplant centers will 
request initial Medicare approval. For those subsequent years, the 
total burden hours are 20 (10 transplant centers x 2 burden hours = 20 
total burden hours) and the total cost estimate would be $1,428.10 (10 
transplant centers x $142.81 = $1,428.10).
    Section 488.61(d) allows transplant centers that have lost their 
Medicare approval to seek re-entry into the Medicare program at any 
time. A center that has lost its Medicare approval must:
    (1) Request initial approval using the procedures at Sec.  
488.61(a);
    (2) Be in compliance with Sec. Sec.  482.72 through 482.104, except 
for Sec.  482.82 (Re-approval Requirements), at the time of the request 
for Medicare approval; and
    (3) Submit a report to us documenting any changes or corrective 
action(s) taken by the center as a result of the loss of its Medicare 
approval status.
    The burden associated with this section would be the time required 
to prepare and submit the request for approval to us pursuant to Sec.  
488.61(a) and the time to prepare and submit a report to CMS 
documenting any changes or corrective actions taken by the center as a 
result of the loss of its Medicare approval status. After further 
analysis of the tasks that would be involved and the personnel that 
would be needed, we believe that developing and submitting the required 
plan would involve the transplant program's medical director, an 
administrator, a transplant coordinator, and appropriate support/
administrative staff.
    In the proposed rule, we said that we believed no more than 9 
entities would be affected by this requirement which made it exempt 
from the PRA, in accordance with 5 CFR 1320.3(c). This was based on our 
previous experience with transplant centers. Previously, only five 
centers had voluntarily terminated their Medicare approval.
    However, this final rule has minimum clinical experience, outcome, 
and process requirements that transplant centers must meet to obtain 
initial Medicare approval and to stay in the program. Considering these 
requirements, we anticipate that more centers may voluntarily terminate 
their Medicare approval status in order to give themselves time to 
correct any problems they may have in meeting these requirements. In 
addition, it may become more common for transplant centers to be 
involuntarily terminated. Therefore, we estimate that up to two percent 
or approximately 10 of the currently Medicare-approved centers may lose 
their status at some point in any given year and later seek to re-enter 
the program.
    We believe that accomplishing all of the tasks necessary for 
complying with Sec.  488.61(d) would require the same staff as needed 
for Sec.  488.61(a) and (b). However, we also believe that the center 
requesting re-entry into the Medicare program will spend more time 
preparing the request due to the preparation of the report documenting 
any changes or corrective action taken by the center as a result of the 
loss of its Medicare approval status. Thus, we believe that a 
transplant center complying with this sub-section's requirements would 
require a total of 5 burden hours and have a total cost estimate of 
$329.50. In any given year, we anticipate as many as 10 centers may 
seek to re-enter the Medicare program. For these 10 centers, the total 
burden hours would be 50 (10 centers x 5 burden hours to re-apply = 50 
total burden hours) and the total cost estimate would be 
$3,295.00($329.50 per center to re-apply x 10 centers = $3,295.00).

[[Page 15260]]



    Total Annual Burden Hours and Total Annual Cost for Transplant Centers Seeking Re-Entry Into the Medicare
                                     Program After Loss of Medicare Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................         $116.60            1.00         $116.60
Senior Administrator............................................           92.31            1.00           92.31
Transplant Coordinator..........................................           43.87            2.50          109.68
Secretary.......................................................           21.81             .50           10.91
                                                                 -----------------------------------------------
    Totals......................................................  ..............            5.00          329.50
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com.

    Thus, for all of the PRA requirements in this rule, the total 
burden hours for the first year are 8,830, and the total cost estimate 
is $659,989.50. For subsequent years the total burden hours are 5,554 
and the total cost estimate is $317,541,66. The burden hours and cost 
estimate are detailed in the chart below. All of the PRA requirements 
noted in this chart constitute new collections of information.

          Summary of PRA Requirements for Transplant Centers (TCs) in the First Year of This Final Rule
----------------------------------------------------------------------------------------------------------------
                                     Total annual    Total annual     Total annual cost     Total annual burden
          PRA requirement            cost estimate   burden hours     estimate for ``X''   hours (BHs) for ``X''
                                        per TC       (BHs)  per TC           TCs                    TCs
----------------------------------------------------------------------------------------------------------------
Sec.   482.74--Notification to CMS         $428.43             6.0  $215,928.72 for 504    3,024 BHs for 504 TCs
 of Significant Changes.                                             TCs (currently there   (currently there are
                                                                     are 504 Medicare       504 Medicare
                                                                     approved TCs).         approved TCs).
Sec.   482.94(c)(3)--Notification           394.58            10.0  $95,882.94 for 243     2,430 BHs for 243 TCs
 to Dialysis Facilities of                                           TCs (currently there   (currently there are
 Patients' Waiting List Status.                                      are 243 Medicare-      243 Medicare-
                                                                     approved kidney TCs).  approved kidney
                                                                                            TCs).
Sec.   482.100--Development of            1,234.81            11.0  $311,172,12 for 252    2,772 BHs for 252 TCs
 Agreement Between T.C. and Each                                     TCs (we estimate       (we estimate that
 OPO on Organ Recovery and                                           that about 50          about 50 percent, or
 Allocation \1\.                                                     percent, or 252, TCs   252, TCs will need
                                                                     will need to re-       to re-draft letters
                                                                     draft letters of       of agreements of
                                                                     agreements of          contracts between
                                                                     contracts between      themselves and their
                                                                     themselves and their   designated OPOs).
                                                                     designated OPOs).
Sec.   482.102(c)(2)--Notification          100.69             3.0  $1,006.90 for 10 TCs   30 BHs for 10 TCs (we
 of Patients on Waiting List of                                      (we estimate that      estimate that about
 Loss of Medicare Approval.                                          about 10 TCs would     10 TCs would lose
                                                                     lose their Medicare    their Medicare
                                                                     Approval each year).   Approval each year).
Sec.   488.61(a)--Application for           142.81             2.0  $73,404.34 for 514     1,028 BHs for 514 TCs
 Medicare Approval \2\.                                              TCs (first year--all   (first year--all 504
                                                                     504 currently          currently Medicare-
                                                                     Medicare-approved      approved TCs would
                                                                     TCs would need to      need to apply and we
                                                                     apply and we           estimate that 10 new
                                                                     estimate that 10 new   TCs would also apply
                                                                     TCs would also apply   for a total of 514
                                                                     for a total of 514     TCs applying for
                                                                     TCs applying for       Medicare approval in
                                                                     Medicare approval in   the first year).
                                                                     the first year).
Sec.   488.61(d)--Application to            329.50             5.0  $3,295.00 for 10 TCs   50 BHs for 10 TCs (we
 Re-Enter Medicare Program.                                          (we estimate that 10   estimate that 10 TCs
                                                                     TCs who had lost       who had lost their
                                                                     their Medicare         Medicare approved
                                                                     approved status        status would seek to
                                                                     would seek to re-      re-enter the
                                                                     enter the Medicare     Medicare Program
                                                                     Program each year)..   each year).
    Totals........................        2,630.82            37.0  700,690.02...........  9,334 BHs.
----------------------------------------------------------------------------------------------------------------
\1\ These estimates are for the first year of implementation only. After the first year, we estimate that fewer
  than 10 transplant centers will need to comply with this requirement. Therefore, in subsequent years, this
  requirement would not be subject to the PRA.
\2\ This estimate is for the first year only. In subsequent years, we estimate that only 10 new transplant
  centers will apply for Medicare approval each year. Thus, for subsequent years, the estimated burden hours
  will be 20 (2 BHs x 10 TCs) and the cost estimate will be $1,428.10 ($142.81 x 10 TCs).

    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-3835-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-3835-F, [email protected]. Fax (202) 395-6974.

V. Regulatory Impact Statement

A. Overall Impact

    We have examined the impact of this final rule as required by 
Executive Order 12866 (September 1993, Regulatory Planning and Review), 
the

[[Page 15261]]

Regulatory Flexibility Act (RFA) (September 16, 1980 Public Law 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 (as amended by Executive Order 13258, which 
merely reassigns responsibilities of duties) directs agencies to assess 
all costs and benefits of available regulatory alternatives and, if new 
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 in any 1 year). 
We estimate the overall economic impact of this final rule to be a cost 
of $28,420,259 and a benefit of $1,257,516 in the first year. The 
social benefits that should result from implementation of this final 
rule are significant. However, we have no reasonably accurate method of 
quantifying those social benefits. Thus, we do not believe that this 
final rule is economically significant.
    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, government agencies, and 
small governmental jurisdictions. Most hospitals and most other 
providers and suppliers are small entities, either by non-profit status 
or by having revenues of $29 million or less in any 1 year (65 FR 
69432). Individuals and states are not included in the definition of a 
small entity. We believe this rule will not have a significant impact 
on a substantial number of small businesses because most of the 
requirements in this final rule are already part of the transplant 
centers' standard practices.
    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 604 of the RFA. For 
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 (superseded by Core Based Statistical Areas) and has 
fewer than 100 beds. We believe this final rule will not have a 
significant impact on small rural hospitals since small rural hospitals 
do not have the resources to perform organ transplants.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by state, 
local or tribal governments, in the aggregate, or by the private 
sector, of $110 million or more. We do not believe that this rule will 
have an effect on state, local or tribal governments, or the private 
sector, that could create an unfunded mandate greater than $110 million 
annually.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a 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. We have determined that this final rule will not 
significantly affect the rights, roles, and responsibilities of states.
    This final rule will affect all facilities that perform, or are 
planning to perform, organ transplants and may have an effect on the 
ability of those facilities to compete. Thus, while we do not believe 
the requirements will have a significant economic impact on these 
facilities, we believe it is desirable to inform the public of the 
likely effect of this final rule on those facilities. Thus, we have 
prepared the following analysis, which in combination with the other 
sections of this final rule, is intended to conform to the objectives 
of the RFA and section 1102(b) of the Act.

B. Anticipated Effects

    Our intent in developing and implementing these CoPs for transplant 
centers is to ensure Medicare-covered transplants are performed in an 
effective, efficient manner and that high quality transplantation 
services are provided to Medicare beneficiaries. This is critical due 
to the scarcity of transplantable organs for the individuals on organ 
transplant waiting lists. This final rule also serves to keep Medicare 
requirements current with the best practices in transplantation. We 
believe that adherence to these outcomes and process requirements will 
result in reduced organ wastage and, as a consequence, fewer graft 
failures and re-transplantations. We do not anticipate that the changes 
in our requirements for transplant centers will affect the number of 
organ transplants performed because this final rule will have no effect 
on the number of organs available for transplantation.
    This final rule will establish CoPs for transplant centers that 
perform organ transplants. The final rule will maintain many of the 
same requirements that are in the current National Coverage Decisions 
(NCDs) for heart, liver, lung, and intestine transplants, and 
conditions for coverage (CfCs) for kidney transplant centers in 42 CFR, 
Part 405, subpart U. Some of the requirements in this final rule could 
result in additional costs for some centers. Although we do not believe 
the requirements in this final rule will have a substantial economic 
impact on a significant number of transplant centers, we believe it is 
desirable to inform the public of our projections of the likely effects 
of this final rule. There are two reasons this final rule will have a 
minimal economic effect.
    As of October 1, 2006, 504 Medicare-approved transplant centers 
potentially will be affected by the requirements in this final rule to 
a greater or lesser degree. However, we believe the majority of the 
transplant centers have already put into practice most of the process 
requirements contained in this final rule. Since these requirements, 
for the most part, reflect advances in transplantation technology, we 
believe they are routine or standard practices for most transplant 
centers. Furthermore, although this final rule requires a large amount 
of data to be submitted, transplant centers are already submitting 
these data to the OPTN.

General Comments

    In the public comments to the proposed rule, some commenters said 
that CMS had underestimated the impact the requirements in the proposed 
rule would have on transplant centers. They stated that the number of 
hours and the costs associated with some requirements were either 
inaccurate or were underestimated.
    We agree with the commenters that in certain instances the economic 
impact was underestimated in the proposed rule. We have performed 
further analysis of the tasks and resources required to satisfy the 
CoPs in this final rule, and we have reviewed more recent economic 
data. Based on this further analysis, we have adjusted our estimate of 
the economic impact for the final rule. These adjustments are discussed 
below for each relevant condition of participation.
    Some commenters said that some of the CoPs in the proposed rule 
were unnecessary because some of the requirements are similar or even 
identical to either current OPTN or JCAHO requirements. We agree that

[[Page 15262]]

some of the CoPs are similar or perhaps even identical to OPTN or JCAHO 
requirements. However, for these requirements to be mandatory and 
enforceable by CMS through our survey and certification process, they 
must be promulgated as regulations.
    Some commenters expressed concern that these new requirements would 
increase costs. One commenter noted that increased costs could result 
in increased organ acquisition fees and subsequent increased expenses 
to the Medicare program and could also reduce access to transplantation 
services for some individuals. The commenter speculated that hospitals 
could have difficulty contracting with managed care organizations due 
to the increased costs.
    As we stated above, we do not believe this rule will have a 
significant economic impact on most transplant centers because most of 
the requirements are routine practice in the majority of centers. In 
addition, all transplant centers are located in hospitals and thus, 
already have access to resources that should minimize the additional 
costs needed to satisfy the requirements in this final rule. Only the 
costs associated with the donor advocate or donor advocate team 
requirements will affect organ acquisition fees. We estimate that in 
the first year of its implementation, the requirements in this final 
rule will increase the cost of a transplant by approximately $1,071 per 
transplant ($28,420,256 total first year costs divided by 26,539 total 
transplants in 2004 = $1,070.88 or about $1,071). However, in 
subsequent years, the increase will drop to approximately $360 per 
transplant (about 9,566,291 implementation costs in subsequent years 
divided by 26,539 total transplants in 2004 = $360.46 or approximately 
$360). In light of the fact that the total first-year cost of an organ 
transplant (including both hospital and physician charges) varies from 
about $175,000 for a kidney transplant to nearly $400,000 for a heart 
transplant, the impact of this rule will be negligible. Thus, hospitals 
should have no difficulty contracting with managed care organizations 
due to the requirements in this final rule.

Section 482.72 Condition of Participation: OPTN Membership

    Section 482.72 requires each transplant center to be located in a 
transplant hospital that is a member of and abides by the rules and 
requirements of the Organ Procurement and Transplantation Network 
(OPTN). Under Sec.  482.45(b)(1) of the hospital CoPs, all transplant 
centers that are currently Medicare-approved are required to be located 
in hospitals that are members of the OPTN and that abide by the OPTN's 
rules. Thus, there is no additional burden or economic impact 
associated with this condition to centers that currently have Medicare 
approval. Since this final rule requires centers to perform a certain 
number of transplants prior to applying for Medicare approval, new 
centers also will be members of the OPTN. Thus, there is no economic 
impact from this requirement to centers that will be applying for 
Medicare approval after the effective date of this rule.

Section 482.74 Condition of Participation: Notification to CMS

    Section 482.74 requires a transplant center to notify us 
immediately of any significant changes related to the center's 
transplant program or changes that could affect its compliance with the 
applicable CoPs. Instances in which CMS should be notified include, but 
are not limited to, changes in key staff members of the transplant 
team; a decrease in the center's number of transplants or survival 
rates that could result in the center being out of compliance with 
Sec.  482.82; termination of an agreement between the hospital in which 
the transplant center is located and an OPO for the recovery and 
receipt of organs; and inactivation of the transplant center.
    We believe that satisfying this requirement would require the 
involvement of the program's medical director, an administrator, a 
transplant coordinator, and appropriate support or administrative 
staff. Based upon our previous experience with transplant centers, we 
believe that three significant changes per year per center is an 
appropriate estimate. We also believe that it would take the above 
described personnel approximately 2 hours to comply with this section.
    Thus, each time a transplant center is required to report a 
significant change to us, the total economic impact or cost estimate is 
$142.81. For the estimated three significant changes per transplant 
center per year, the total cost estimate would be $428.43. Since there 
are currently approximately 504 Medicare-approved transplant centers, 
the total annual cost estimate for complying with this section is 
$215,928.72 ($428.43 annual cost estimate per center x 504 transplant 
centers = $215,928.72).

Section 482.76 Condition of Participation: Pediatric Transplants

    Section 482.76 requires transplant centers that want Medicare 
approval to provide transplant services to pediatric patients to submit 
to us a request specifically for Medicare approval to perform pediatric 
transplants using the procedures described in Sec.  488.61, Special 
procedures for approval and re-approval of organ transplant centers. 
Section 482.76(d) allows heart transplant centers that want to provide 
transplantation services to pediatric heart patients to be approved to 
perform pediatric heart transplants by meeting the OBRA 1987 criteria 
in section 4009(b) (Pub. L. 100-203) as follows: (1) The center's 
pediatric transplant program must be operated jointly by the hospital 
and another facility that is Medicare-approved; (2) the unified program 
shares the same transplant surgeons and quality improvement program 
(including oversight committee, patient protocol, and patient selection 
criteria); and (3) the center demonstrates to the satisfaction of the 
Secretary that it is able to provide specialized facilities, services, 
and personnel that are required by pediatric heart transplant patients.
    We believe that most transplant centers that want to obtain 
Medicare approval to do pediatric transplants will use the procedures 
at Sec.  488.61. Therefore, the economic impact for centers requesting 
approval to do pediatric transplants will be discussed under that 
section. For those centers that want to request approval using the 
alternative criteria, we believe there will be some impact, but it will 
be minimal and should affect very few centers. Currently, there are 
approximately 13 pediatric heart centers; 6 of these centers are 
Medicare approved. Based on these figures, we expect that no more than 
one pediatric heart center will apply for Medicare approval per year.

Section 482.80 Condition of Participation: Data Submission, Clinical 
Experience, and Outcome Requirements for Initial Approval of Transplant 
Centers

    Section 482.80 requires that transplant centers must generally meet 
all data submission, clinical experience, and outcome requirements to 
be granted initial approval by CMS. Section 482.80(a) states that no 
later than 90 days after the due date established by the OPTN, a 
transplant center must submit to the OPTN at least 95 percent of the 
required data on all transplants, (deceased and living donors) it has 
performed. The required data submissions include, but are not limited 
to, submission of the appropriate OPTN forms for transplant candidate 
registration, transplant recipient registration and follow-up, and 
living donor registration and follow-up. However, transplant centers 
already

[[Page 15263]]

submit these data to the OPTN, using the time frame specified by the 
OPTN, as required by 42 CFR 121.11, which regulates transplant 
hospitals' submission of data to the OPTN. Therefore, there is no 
additional cost to transplant centers from the data submission 
requirement in this final rule. Section 482.80(b) establishes a 
clinical experience requirement of 10 transplants in a 12-month period 
for initial Medicare approval for heart, intestine, kidney, liver, and 
lung transplant centers. The clinical experience requirement for 
initial approval for kidney centers is 3 transplants in a 12-month 
period. (See Sec.  482.80(d)(5).)
    Current national coverage decisions require 10 transplants for 
intestine and lung centers and 12 transplants for liver and heart 
centers. Current conditions for coverage for kidney transplant centers 
require 15 or more kidney transplants annually for a center to have 
unconditional status. Thus, all currently approved transplant centers 
should be performing the minimum number of transplants required.
    Furthermore, even if a center does not meet the clinical experience 
requirements, we may grant the center initial Medicare approval based 
on a review of the center's compliance with the relevant conditions of 
participation at Sec.  482.72 through Sec.  482.76 and Sec.  482.90 
through Sec.  482.104. (See Sec.  488.61(a)(3).)
    Nevertheless, some centers may not be granted Medicare approval due 
to their failure to satisfy the clinical experience requirements. Loss 
of Medicare approval is likely to result in the center losing patients. 
If a center with current Medicare approval applies for and is denied 
Medicare approval under this final rule, it has the option to leave the 
Medicare program voluntarily until it can satisfy the requirements.
    Although we believe the economic impact of the clinical experience 
requirements will be minimal, we are not aware of any research that 
quantifies the cost or benefit to a hospital of having a transplant 
center. Anecdotal information indicates that some hospitals with a 
transplant center lose money or break even but that some hospitals 
experience a financial benefit. Whether a transplant center is a 
benefit or a cost to a hospital may depend at least in part on the type 
of organ transplanted, the volume of transplants performed, and the 
center's operational efficiency.
    We also recognize that there may be benefits and/or costs to 
Medicare beneficiaries and other patients on the waiting lists of 
centers that lose Medicare approval, although we do not believe it is 
possible to quantify the benefits or costs. Benefits would include 
improved patient safety and better outcomes for patients who transfer 
to the waiting lists of transplant centers that furnish higher quality 
transplantation services. Costs could include increased cost for 
transportation to a center that is farther from a waiting list 
patient's home and an increase in the time until an organ becomes 
available, with the potential for increased morbidity and mortality.
    Section 482.80(c) states that CMS will review outcomes for all 
transplants performed at a center, including outcomes for living donor 
transplants, if applicable. Except for lung transplants, CMS will 
review adult and pediatric outcomes separately when a center requests 
Medicare approval to perform both adult and pediatric transplants. 
Outcome data must be available for review. CMS will compare each 
transplant center's observed number of patient deaths and graft 
failures 1 year post-transplant to the center's expected number of 
patient deaths and graft failures 1-year post-transplant using the data 
contained in the most recent SRTR center-specific reports. (See Sec.  
488.61(d)(1).) The required number of transplants must have been 
performed during the time frame reported in the most recent SRTR 
center-specific report. (See Sec.  488.61(c)(2).) CMS will not consider 
a center's patient and graft survival rates to be acceptable if: (1) A 
center's observed patient survival rate or observed graft survival rate 
is lower than its expected patient survival rate or expected graft 
survival rate; and (2) all three of the following thresholds are 
crossed over: (A) the one-sided p-value is less than 0.05, (B) the 
number of observed events (patient deaths or graft failures) minus the 
number of expected events is greater than 3, and (C) the number of 
observed events divided by the number of expected events is greater 
than 1.5. (See Sec.  488.61(c)(3).)
    Current national coverage decisions for heart, liver, lung, and 
intestine transplants already contain outcome requirements. However, 
those outcome requirements only concern patient (not graft) survival 
rates. The outcome requirements associated with Sec.  482.80(c) are 
more comprehensive because they include graft survival. We believe that 
more centers may have difficulty in meeting these new standards. 
However, under Sec.  488.61(a)(3), CMS, as an option, may approve a 
center that does not meet the patient and graft survival if a survey of 
the center demonstrates that the center was in compliance with Sec.  
482.72 through Sec.  482.76 and Sec.  482.90 through Sec.  482.104. In 
addition, a center also may choose to withdraw voluntarily from the 
Medicare program and seek re-entry after it has corrected any problems. 
(See 42 CFR Sec.  488.61(d).) Thus, we believe the economic impact from 
the new outcome measures will be minimal.

Section 482.82 Condition of Participation: Data Submission, Clinical 
Experience, and Outcome Measure Requirements for Re-Approval of 
Transplant Centers

    Section 482.82 provides that transplant centers must generally meet 
all data submission, clinical experience, and outcome requirements in 
order to be re-approved. The data submission, clinical experience, and 
outcome requirements and exceptions to those requirements generally are 
identical to those in Sec.  482.80, which contains the requirements for 
initial approval. However, in this section, the review will cover the 
3-year approval period.
    The economic impact of this section is the same as the economic 
impact of Sec.  482.80, except that transplant centers will have to 
comply with these requirements for the entire time they have Medicare 
approval. Thus, the economic impact associated with this section 
constitutes an annual economic impact for all of the centers with 
Medicare approval. However, we believe the economic impact will be 
minimal.

Section 482.90 Condition of Participation: Patient and Living Donor 
Selection

    Section 482.90 requires transplant centers to use written patient 
selection criteria in determining a patient's suitability for placement 
on the waiting list or a patient's suitability for transplant. If a 
center performs living donor transplants, the center also must use 
written donor selection criteria in determining the suitability of 
candidates for donation.
    Section 482.90(a) requires that before a prospective transplant 
candidate is placed on a center's waiting list, each prospective 
transplant candidate shall receive a psychosocial evaluation, if 
possible. In addition, the candidate's medical record must contain 
documentation that the candidate's blood type has been determined. When 
a patient is placed on a center's waiting list or is selected to 
receive a transplant, the center must document in the patient's medical 
record the patient selection criteria used. A transplant center must 
provide a copy of its patient selection criteria to a transplant 
patient,

[[Page 15264]]

or a dialysis facility, as requested by the patient or the dialysis 
facility.
    In our experience, all or nearly all transplant centers conduct 
psychosocial evaluations of transplant candidates. Such evaluations are 
performed routinely so that centers can evaluate how well a prospective 
candidate will do after transplantation (for example, whether the 
patient is likely to be compliant with the immunosuppressive 
medications needed to prevent graft failure). Thus, we expect no 
economic impact from this requirement for most transplant centers.
    In the public comments we received on the proposed rule, some 
commenters said that the patient selection criteria requirements would 
be burdensome. For example, one commenter said that it would take at 
least 30 minutes of staff time to document the patient selection 
criteria in the file of each patient or living donor. Some commenters 
indicated that the patient selection criteria would need constant 
updating. They also noted that the proposed rule did not contain an 
analysis of the economic impact for this requirement.
    We disagree that the requirement to have written patient selection 
criteria would have a significant impact on transplant centers. We 
expect that heart, liver, and lung transplant centers already have 
patient selection criteria because current NCDs require these centers 
to have such criteria. Further, Medicare coverage of pancreas and 
intestine transplants is based on specific clinical indicators. 
Although there are no current requirements for kidney transplant 
centers to have patient selection criteria, based on our experience, we 
expect that all or nearly all centers already have such criteria 
because many kidney transplant centers provide their patient selection 
criteria to local dialysis facilities. Therefore, complying with this 
requirement should have no additional impact on heart, liver, and lung 
centers and only a minimal impact on other transplant centers.
    We believe that transplant centers should be able to document the 
patient selection criteria in a patient's medical record in 
considerably less than 30 minutes. Generally, documenting the patient 
selection criteria in a patient's medical record should involve no more 
than tracking the patient's primary diagnosis and any co-morbid 
conditions to the appropriate patient selection criteria. Under this 
final rule, each center has the flexibility to determine the most 
expedient way to satisfy this requirement. Centers should be able to 
significantly reduce the resources needed to document the required 
information in the potential transplant recipient and living donor 
medical records by using electronic formats, forms, or checklists.
    In addition, it is standard medical practice to document in the 
medical record of a hospital patient undergoing surgery whether the 
patient meets the hospital's criteria for surgery. Although we do not 
know how many prospective transplant candidates would be interested in 
requesting a copy of a transplant center's patient selection criteria, 
we believe that the activities required by this section would have a 
minimal economic impact on transplant centers. Supplying a copy of 
patient selection criteria to a dialysis facility at its request can be 
done electronically and should require only minimal effort. Thus, we 
believe that the activities required by this section would require no 
additional staff and have only a minimal economic impact on transplant 
centers.
    Section 482.90(b) provides that transplant centers performing 
living donor transplants must ensure that each prospective living donor 
receives a medical and psychosocial evaluation prior to donation and 
must document in the living donor's medical records both the living 
donor's suitability for donation and that the living donor has given 
informed consent, as required under Sec.  482.102.
    We expect the economic impact of these living donor requirements to 
be minimal, as they are similar to the requirements for transplant 
patients discussed previously. Due to the potential risks associated 
with donation, we expect that every transplant center that performs 
living donor transplants already has criteria for the selection of 
living donors, as well as protocols that require a medical and 
psychosocial evaluation of the donor. In addition, as with any other 
surgical procedure, documenting a living donor's informed consent 
should be standard practice for any transplant center. Thus, we believe 
that these activities would constitute a minimal economic burden to 
centers that perform living donor transplants.

Section 482.92 Condition of Participation: Organ Recovery and Receipt

    Transplant centers must have written protocols for validation of 
donor-recipient blood type and other vital data for the deceased organ 
recovery, organ receipt, and living donor organ transplantation 
processes. There are also specific requirements related to each of 
these processes, such as a requirement that the transplanting surgeon 
and another licensed health care professional at the transplant center 
must verify that the donor's blood type and other vital data are 
compatible with transplantation of the intended recipient prior to 
transplantation. (See Sec.  482.90(b).)
    We expect that all transplant centers already have written 
protocols for critical functions addressed within this section. 
Although some centers' protocols may need to be reviewed and revised so 
that they satisfy the requirements in this section, the economic impact 
will be negligible.

Section 482.94 Condition of Participation: Patient and Living Donor 
Management

    Transplant centers must have written patient management policies 
for the transplant and discharge phases of transplantation. If a 
transplant center performs living donor transplants, the center also 
must have written donor management policies for the donor evaluation, 
donation, and discharge phases of living organ donation.
    We expect that it is standard practice for transplant centers to 
have written policies for the evaluation, transplant, and discharge 
phases of transplantation. Thus, developing written policies for these 
areas should have no economic impact on most transplant centers. 
However, we acknowledge that some of the centers' written policies may 
need to be revised to satisfy the individual standards in this section. 
Thus, the economic impact of individual standards will be discussed 
below.
    Section 482.94(a) states that a transplant center's patient and 
donor management policies must ensure that each transplant patient is 
under the care of a multidisciplinary patient care team coordinated by 
a physician throughout the transplant and discharge phases of 
transplantation. If the center performs living donor transplants, the 
same patient care requirement applies for living donors throughout the 
donor evaluation, donation, and discharge phases of donation.
    We believe that it is a standard practice for hospitals to have 
patient management policies that cover both the in-patient stay and 
discharge planning. Thus, we expect that transplant centers already 
have patient and donor management policies for the transplant and the 
discharge phases of transplantation. Due to the potential risks to 
living donors, we expect that every transplant center that performs 
living donor transplants already has written policies that cover the 
evaluation of living donors. We acknowledge that publication of this 
final rule may cause some centers to

[[Page 15265]]

review or revise their policies to ensure that they are in compliance. 
However, the economic impact on these transplant centers will be 
minimal.
    Section 482.94(b) requires that transplant centers must keep their 
waiting lists up to date on an ongoing basis, including: (1) Updating 
of waiting list patients' clinical information; (2) removing patients 
from the center's waiting list if a patient receives a transplant or 
dies, or if there is any other reason why the patient should no longer 
be on a center's waiting list; and (3) notifying the OPTN no later than 
24 hours after a patient's removal from the center's waiting list.
    We believe these activities are standard practice for most 
transplant centers. Transplant centers must keep their patients' 
clinical information updated to ensure that organ offers are made for 
patients appropriately, based on their clinical status. Further, the 
OPTN requires transplant centers to: (1) Remove a patient from the 
waiting list if the patient receives a transplant or dies; and (2) 
notify the OPTN within 24 hours of the patient's transplantation or 
death. Thus, there should be no economic impact on transplant centers 
from this requirement.
    Section 482.94(c) requires transplant centers to maintain up-to-
date and accurate patient management records for each patient who 
receives an evaluation for placement on a center's waiting list and who 
is admitted for organ transplantation.
    Section 482.94(c)(1) states that for each patient who receives an 
evaluation for placement on a center's waiting list, the center must 
document in the patient's record that the patient has been informed of 
his or her transplant status, including notification of the patient's 
placement on the center's waiting list, the center's decision not to 
place the patient on its waiting list, or the center's inability to 
make a determination regarding the patient's placement on its waiting 
list because further clinical testing or documentation is needed.
    Section 482.94(c)(2) states that if a patient on the center's 
waiting list is removed for any reason other than death or 
transplantation, the center must document in the patient's record that 
the patient was notified no later than 10 days after the date the 
patient was removed from the center's waiting list.
    Section 482.94(c)(4) states that in the case of patients admitted 
for organ transplants, transplant centers must maintain written records 
of multidisciplinary patient care planning during the transplant period 
and multidisciplinary discharge planning for post-transplant care.
    All transplant centers must follow OPTN requirements regarding 
notification of patients and maintenance of their waiting lists. If a 
patient on the waiting list is removed from the waiting list for any 
reason other than death or transplantation, Sec.  482.94(c)(2) requires 
the transplant center to document in the patient's record that the 
patient was notified not later than 10 days after the date the patient 
was removed from the waiting list. The OPTN already requires this 
notification, and documentation of the patient's record would be usual 
and customary business practice. Since we expect that all transplant 
centers are already complying with this requirement, there should be no 
economic impact on transplant centers from this requirement of the 
final rule. Thus, we believe that transplant centers already comply 
with the requirements in Sec.  482.94(c), with the exception of the 
requirement for notification of dialysis facilities. Therefore, there 
is no economic impact on transplant centers from these requirements.
    Sections 482.94(c)(1) and (2) require kidney transplant centers, in 
the case of dialysis patients, to notify the patients' usual dialysis 
facility. Since this is not an OPTN requirement, we do not believe that 
all transplant centers currently notify dialysis facilities about this 
information. When a kidney transplant center must notify a patient 
within 10 days about a change in status, the transplant center could 
choose to inform the dialysis facility at the same time it notifies the 
patient. If it did, we believe the burden of complying with this 
requirement would be minimal. However, the transplant center also could 
choose to notify the dialysis facilities periodically about other 
changes in status.
    For the purpose of estimating the economic impact, we will assume 
that rather than notifying dialysis facilities on a flow basis for each 
patient, transplant centers will update dialysis centers periodically 
about the status of all patients. Thus, for the purposes of determining 
the burden for this requirement, we will assume quarterly notifications 
by transplant centers to dialysis facilities.
    According to the OPTN, as of December 31, 2005, there were 64,848 
individuals awaiting kidney transplants. Currently, there are 4,649 
dialysis facilities in the United States. Since the number of patients 
at these facilities varies greatly, the following analysis will use the 
average number of dialysis patients at a facility. There are currently 
approximately 243 Medicare-approved kidney transplant centers. 
Therefore, each transplant center has patients on its kidney transplant 
waiting list from an average of 19 (4,649 dialysis facilities divided 
by 243 Medicare-approved kidney transplant centers = 19.13) dialysis 
centers. Since there are 64,848 patients waiting for kidney transplants 
and 4,649 dialysis facilities, each transplant center has an average of 
14 kidney waiting list patients at each dialysis facility (64,848 
patients divided by 4,649 dialysis facilities = 13.9). For each of the 
243 kidney transplant centers, there are about 267 patients (64,848 
patients divided by 243 transplant centers = 266.86 or 14 patients per 
dialysis facility x 19 dialysis facilities = 266). Thus, on average, 
each transplant center will have to determine the status of about 267 
patients and notify an average of 19 dialysis facilities about the 
status of these patients 4 times per year.
    Based upon our past experience, we believe that this notification 
will require the involvement of the transplant coordinator and 
appropriate support/clerical staff. We anticipate that transplant 
centers will utilize modern technology to minimize the burden of 
satisfying this requirement.

    Total Annual Burden Hours and Total Annual Cost Estimate To Notify Dialysis Facilities of Their Patients'
                                               Waiting List Status
----------------------------------------------------------------------------------------------------------------
                                                                                   Total annual
                                                   Burden hours    Cost estimate  hours required   Total annual
            Position                Hourly wage      per event       per event         (for 4      cost estimate
                                                                                      events)      for 4 events)
----------------------------------------------------------------------------------------------------------------
Transplant coordinator..........          $43.87            2.00          $87.74             8.0         $350.96
Secretary.......................           21.81             .50           10.90             2.0           43.62
                                 -------------------------------------------------------------------------------

[[Page 15266]]

 
    Total.......................  ..............            2.50           98.64           10.00         394.58
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com.

    Thus, we anticipate that each quarterly notification will cost 
about $98.64. With the transplant centers conducting these 
notifications on a quarterly basis (that is, 4 notifications per year 
for each kidney center), the total annual economic impact to each 
kidney transplant center would be $394.58. Since there are currently 
about 243 Medicare-approved kidney transplant centers, the total 
economic impact from this requirement will be $95,882.94 annually (243 
transplant centers x $394.58 = $95,882.94).
    Section 482.94(d) states that a transplant center must make social 
services, furnished by qualified social workers, available to 
transplant patients, living donors, and their families. A qualified 
social worker is an individual who meets licensing requirements in the 
State in which he or she practices and (1) has completed a course of 
study with specialization in clinical practice and holds a masters 
degree from a graduate school of social work accredited by the Council 
on Social Work Education, or, (2) is working as a social worker in a 
transplant center as of the effective date of this final rule and has 
served for at least 2 years as a social worker, 1 year of which was in 
a transplantation program, and has established a consultative 
relationship with a social worker who is qualified under Sec.  
482.94(d)(1).
    Current policies for heart, liver, and lung transplants require 
facility commitment at all levels, including social service resources. 
We believe nearly all transplant centers already have a qualified 
social worker to provide social services. Further, we have been careful 
to retain an exception for bachelor's-prepared social workers so that 
transplant centers that employ these social workers do not have to 
replace them with master's-prepared social workers, if they were 
employed as social workers in the transplant center as of the effective 
date of this final rule and served for at least 2 years as a social 
worker, 1 year of which was in a transplantation program, and has 
established a consultative relationship with a social worker who is 
qualified under Sec.  482.94(d)(1). Thus, satisfying this requirement 
would constitute a minimal economic impact for most, if not all, 
centers.
    Section 482.94(e) states that transplant centers must make 
nutritional assessments and diet counseling services, furnished by a 
qualified dietician, available to all transplant patients and living 
donors. A qualified dietician is an individual who meets practice 
requirements in the State in which he or she practices, and is a 
registered dietician with the Commission on Dietetic Registration.
    Some commenters said that this requirement was too expensive and 
burdensome. We disagree. Kidney transplant centers are required by ESRD 
CfCs at Sec.  405.2171(c) to ensure patients receive nutritional 
services from a qualified dietician. Thus, all kidney centers currently 
should be providing these services to transplant patients and living 
donors. We expect that most extra-renal transplant centers provide 
nutritional services to transplant patients, because these patients 
have very specific nutritional needs. Some liver, lung, and intestine 
centers that transplant organs from living donors may need to obtain a 
dietician's services for their living donors if they do not already 
provide these services. However, since the number of living liver, 
lung, and intestine donors in 2004 totaled fewer than 400, we believe 
liver, lung, and intestine centers can obtain nutritional services for 
their living donors from dieticians already employed by the hospitals 
in which the centers are located at little cost to the center. Thus, we 
expect the economic impact to be minimal.

Section 482.96 Condition of Participation: Quality Assessment and 
Performance Improvement (QAPI)

    Section 482.96 requires transplant centers to develop, implement, 
and maintain a written, comprehensive, data-driven QAPI program 
designed to monitor and evaluate performance of all transplantation 
services, including services provided under contract or arrangement.
    Section 482.96(a) states that the transplant center's QAPI program 
must use objective measures to evaluate the center's performance with 
regard to transplantation activities and outcomes. Outcomes may 
include, but are not limited to, patient and donor selection criteria, 
accuracy of the waiting list in accordance with the OPTN waiting list 
requirements, accuracy of donor and recipient matching, patient and 
donor management, techniques for organ recovery, consent practices, 
patient education, patient satisfaction, and patient rights. The 
transplant center must take actions that result in performance 
improvements and track performance to ensure that improvements are 
sustained.
    Section 482.96(b) requires transplant centers to establish and 
implement written policies to address and document adverse events that 
occur during any phase of an organ transplantation case. These policies 
must address, at a minimum, the process for identification, reporting, 
analysis, and prevention of adverse events. When an adverse event is 
identified, the transplant center must conduct a thorough analysis of 
and document any adverse event. The center must then use this analysis 
to effect changes in its policies and practices in order to prevent 
repeat incidents.
    In the proposed rule, we estimated that only a minority of centers 
did not already have a data-driven QAPI program. For those centers that 
would need to develop a QAPI program that would satisfy this 
requirement, we estimated that a center would likely utilize an 
experienced individual from its hospital QAPI staff. We used the salary 
of a registered nurse (RN) to estimate the economic impact, since many 
QAPI coordinators are RNs. We noted that the 2002 mean annual income of 
an RN was $42,730 and requested comments addressing whether transplant 
centers would be able to utilize individuals from the hospital's 
existing QAPI staff to develop and implement a QAPI program specific to 
the transplant center or whether transplant centers would need to hire 
additional staff in order to comply with this proposed requirement. We 
did not make a specific estimate of the economic burden; however, we 
estimated the PRA burden to be 8 hours

[[Page 15267]]

on a one-time basis to comply with this requirement.
    Comment: Some commenters disagreed with the resources we believed 
would be required to satisfy this requirement. One commenter stated 
that a large center would require one FTE to comply with this 
requirement. Another commenter indicated that it took 160 staff hours 
to develop and establish the QAPI program at their hospital and 1.25 
FTEs to maintain the program. This commenter indicated that 8 hours 
would be only a ``start'' in complying with this requirement. Others 
noted that the establishment, implementation, and maintenance of such a 
QAPI program would be much more complex and would require more 
resources.
    Other commenters disagreed with our use of the 2002 mean annual RN 
salary of $42,730. One commenter noted that a budget of $42,000 would 
not cover their projected expenses to satisfy this requirement. Another 
commenter also noted that this was insufficient. They noted the nursing 
shortage and that most of the clinical coordinators who would be doing 
this work were generally both highly experienced and trained, and held 
either a bachelor's or master's degree. One commenter explicitly said 
that the average annual national RN salary was not the appropriate 
salary to use in estimating the burden associated with the QAPI 
requirement.
    Another commenter cautioned us about assuming that the hospital's 
QAPI program would satisfy this requirement. The commenter stated that 
although a hospital QAPI program may be able to support a single 
transplant center, the scope and complexity of multiple transplant 
centers would require more resources.
    Response: We acknowledge that we underestimated the economic impact 
of the QAPI requirement in the proposed rule. It clearly will take more 
than 8 hours to develop and implement the policies necessary to comply 
with this section. We also agree that the use of the 2002 mean annual 
national RN salary is inadequate. However, while we agree that a 
hospital QAPI program may be inadequate to fully support its transplant 
center, particularly if a hospital has multiple transplant centers, we 
believe that the hospital's QAPI program would be a substantial 
resource for the staff responsible for the transplant center's QAPI 
program.
    We believe that many centers have already established and 
implemented a QAPI program that satisfies this final rule's QAPI 
requirement. However, some of the centers may need to review and revise 
their programs. We believe this will constitute only a minimal economic 
impact to those centers.
    Some centers may need to develop and implement a QAPI program. 
Beginning in 2003, hospitals are required to have hospital-wide QAPI 
programs that involve all hospital departments. (See 42 CFR 482.20.) 
Therefore, we believe that no more than 20 percent of the 504 currently 
Medicare-approved centers (101 centers) will need either to develop and 
implement a QAPI program or substantially revise an existing program. 
We also believe that no more than 40 percent of the centers (202 
centers) will need to perform moderate revisions to their programs so 
that they will satisfy the QAPI requirements in this final rule. 
However, since each center is located in a hospital, we believe that 
centers will have substantial resources to draw upon in developing 
their QAPI programs.
    Based on our past experience, we believe it is likely that centers 
will utilize an experienced staff person, possibly an experienced RN 
with some knowledge of the transplant program. An individual with this 
experience would likely be paid approximately the same as a transplant 
nurse coordinator or about $91,456 annually. We have considerable 
experience providing guidance to OPOs in developing comprehensive QAPI 
programs, which has provided us with knowledge of how many staff 
resources are needed to implement or modify a data-driven QAPI program. 
We believe it will require 1 FTE for each one of the 101 centers that 
will need either to develop a QAPI program or perform substantial 
revision to an existing QAPI program. We believe it will require half 
of an FTE for each one of the 202 centers that will need to perform at 
least moderate revisions to their programs. The cost to the 101 centers 
that need 1 FTE would be $9,237,056 ($91,456 x 101 = $9,237,056), and 
the cost to the 202 centers that need a half FTE would be $9,237,056 
($91,456 divided by 2 = $45,728 and $45,728 x 202 centers = 
$9,237,056). The total economic impact of this requirement on the 
transplant centers would be $18,474,112 ($9,237,056 + $9,237,056 = 
$18,474,112).
    This section also requires the centers to maintain their QAPI 
programs. We believe that having and maintaining a QAPI program should 
be considered standard practice by the transplant centers. Once the 
center's QAPI program is developed and implemented, we believe that 
maintaining it would have a minimal economic impact on the transplant 
centers.

Section 482.98 Condition of Participation: Human Resources

    Section 482.98 states that transplant centers must ensure that all 
individuals who provide services and/or supervise services at the 
center, including individuals furnishing services under contract or 
arrangement, are qualified to provide or supervise such services. 
Section 482.98(a) requires each transplant center to be under the 
general supervision of a qualified transplant surgeon or qualified 
physician-director. This director need not serve full time and may also 
serve as the center's primary transplant surgeon or transplant 
physician. Section 482.98(b) requires transplant centers to identify to 
the OPTN a primary transplant surgeon and a transplant physician with 
appropriate training and experience to provide transplantation 
services, who are immediately available to provide transplantation 
services when an organ is offered for transplantation.
    Any economic impact associated with these requirements should be 
minimal. The current regulations for kidney transplant centers already 
require renal transplant centers to be supervised by a qualified 
transplantation surgeon or qualified physician-director, and we expect 
most extra-renal transplant centers have a director who would be 
considered qualified under this final rule. The OPTN requires 
transplant centers to have transplant surgeons and physicians with 
specific qualifications, training, and experience, and we believe that 
in most transplant centers, the primary transplant surgeon and 
transplant physician are immediately available to provide 
transplantation services when an organ is offered for a patient.
    Section 482.98(c) requires transplant centers to have a clinical 
transplant coordinator who is either a registered nurse or other 
licensed clinician who has experience and knowledge of transplantation 
and living donation issues. Based on our experience with transplant 
centers, we believe that all or nearly all centers already have a 
clinical transplant coordinator on staff to coordinate all patient care 
and management activities. Therefore, we do not believe that this 
requirement will constitute any additional burden for transplant 
centers.
    Section 482.98(d) states that transplant centers that perform 
living donor transplantation must identify either an independent living 
donor advocate or an independent living donor advocate team to ensure 
the protection of the rights of living donors and prospective living 
donors. This

[[Page 15268]]

individual(s) must not be involved in transplantation activities on a 
routine basis.
    Due to the potential risks living donors face, we believe it is 
crucial that living donors have an independent living donor advocate or 
advocate team. In addition, due to their growing numbers, there is an 
urgent need to provide this type of service for these living donors. 
According to the 2005 OPTN/SRTR Annual Report, in 2003, there were a 
total of 6,820 living donors. In 2004, there were a total of 7,002 
living donors, of which 6,645 were living kidney donors, 323 were 
living liver donors, 28 were living lung donors, and 6 were living 
intestine donors.
    In determining an economic impact for this requirement, it is 
important to note that the number of living donors at a particular 
transplant center varies greatly. In order to estimate the economic 
impact, we have determined the annual average number of living donors 
per center, based on the annual number of living kidney and living 
liver donors. Since there are so few living lung and intestine donors, 
we have not estimated the impact of this requirement on lung or 
intestine transplant centers.
    There are currently about 243 Medicare-approved kidney transplant 
programs. However, 31 of those centers perform only pediatric kidney 
transplants. Based on our review of data from the SRTR, pediatric 
kidney centers transplant very few kidneys from living donors. However, 
nearly all of the 212 adult kidney transplant centers perform living 
kidney transplants. There are currently 90 Medicare-approved liver 
transplant centers. However, in 2005 only about 36 percent or about 32 
of those centers performed living liver transplants. We expect that at 
least half of the kidney and liver centers that perform living donor 
transplants already have a donor advocate or donor advocate team that 
fulfills the requirements of this final rule. Thus, we will determine 
an estimate of the economic impact for this requirement based on 106 
kidney transplant centers (half the number of currently Medicare-
approved kidney transplant centers) and 16 liver transplant centers 
(half the number of currently Medicare-approved liver transplant 
centers that perform living transplants).
    Although some centers may choose to develop an independent living 
donor advocate team, we believe that most centers will choose to have 
an independent living donor advocate. Most centers will probably choose 
either an RN or a social worker to fill this position. We believe that 
the total annual compensation for this position would be approximately 
$81,124, which is the median annual total compensation for a renal 
dialysis staff nurse. Due to the number of living kidney donors, we 
believe that on average each center will need to have 1 FTE for the 
independent living donor advocate position. Thus, the total annual 
economic impact to kidney transplant centers would be $8,599,144 
($81,124 x 106 transplant centers = $8,599,144). However, there are far 
fewer living liver transplants performed per transplant center. 
Although each center will vary in the number of transplants performed, 
we estimate that on average each center will need about half FTE for an 
independent living donor advocate. Thus, the total annual economic 
impact to the liver transplant centers will be $648,992 ($81,124 x .5 = 
$40,562 x 16 centers = $648,992). Thus, the total economic impact for 
this requirement is $9,248,136 ($8,599.144 + $648,992 = $9,248,136).
    Section 482.98(e) states that transplant centers must identify a 
multidisciplinary transplant team and describe the responsibilities of 
each member of the team. The team must be composed of individuals with 
the appropriate qualifications, training, and experience in the 
relevant areas of medicine, nursing, nutrition, social services, 
transplant coordination, and pharmacology.
    Current NCDs for heart, liver, and lung transplant centers require 
them to have multi-disciplinary transplant teams, and current CfCs for 
kidney transplant centers require them to have both social workers and 
dieticians. We believe that all transplant centers have identified 
their multidisciplinary transplant teams and described the 
responsibilities of each member of that team. Thus, we do not 
anticipate that this requirement will have any economic impact on 
centers.
    Section 482.98(f) states that each transplant center must 
demonstrate availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, blood banking, and patient education as related to the 
provision of transplantation services. Current NCDs for heart, liver, 
and lung transplant centers have similar requirements. Since every 
transplant center is part of a larger hospital, we expect that all 
transplant centers already have access to expertise in all of these 
areas. Therefore, this requirement will result in no additional 
economic impact.

Section 482.100 Condition of Participation: Organ Procurement

    Section 482.100 requires a transplant center to ensure that the 
hospital in which it operates has a written agreement for the receipt 
of organs with an OPO designated by the Secretary that identifies 
specific responsibilities for the hospital and for the OPO with respect 
to organ recovery and organ allocation.
    Therefore, we expect that all centers have some type of written 
agreement or contract with an OPO. However, these agreements may not 
satisfy the requirements of this section. Thus, we believe that 
approximately 50 percent of the 504 centers or 252 centers would need 
to revise the agreements between themselves and their designated OPOs 
for the receipt of organs that identify specific responsibilities for 
the hospital and for the OPO with respect to organ recovery and organ 
allocation.

Total Annual Burden Hours and Total Annual Cost Estimate To Develop an Agreement Between a Transplant Center and
                              an OPO Concerning Organ Recovery and Organ Allocation
----------------------------------------------------------------------------------------------------------------
                                                                                   Total annual    Total annual
                            Position                                Hourly wage   hours required   cost estimate
----------------------------------------------------------------------------------------------------------------
General Counsel or Attorney.....................................         $176.86             4.0         $707.44
Medical Director................................................          116.60             2.0          233.20
Senior Administrator............................................           92.31             2.0          184.62
Transplant Coordinator..........................................           43.87             2.0           87.74
Secretary.......................................................           21.81             1.0           21.81
                                                                 -----------------------------------------------
    Totals......................................................  ..............           11.00       1,234.81
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com


[[Page 15269]]

    Based on our experience with health care organizations, agreements 
of this type would require the involvement of the hospital's attorney 
and an administrator. It would also involve the transplant center's 
director, transplant coordinator, and appropriate clerical/support 
staff. We believe that it would require a total of approximately 11 
hours to negotiate and draft a mutually acceptable agreement that would 
be signed by both the transplant center and the OPO.
    For each hospital in which one of the 252 transplant centers is 
located, the total cost estimate to negotiate and draft an organ 
recovery and organ allocation agreement with its designated OPO is 
$1,234.81. The total cost estimate is $311,172.12 (252 transplant 
centers x $1,234.81 = $311,172.12).

Section 482.102 Condition of Participation: Patient and Living Donor 
Rights

    Section 482.102 requires transplant centers to implement written 
transplant patient informed consent policies that inform each patient 
about: (1) The evaluation process; (2) the surgical procedure; (3) 
alternative treatments; (4) potential medical or psychosocial risks; 
(5) national and transplant center-specific outcomes; (6) organ donor 
risk factors that could affect the success of the graft or the health 
of the patient, including, but not limited to, the donor's history, 
condition or age of the organs used, or the patient's potential risk of 
contracting the human immunodeficiency virus and other infectious 
diseases if the disease cannot be detected in an infected donor; (7) 
his or her right to refuse transplantation; and (8) the fact that if a 
transplant is not provided in a Medicare-approved transplant center, it 
could affect the transplant recipient's ability to have his or her 
immunosuppressive drugs paid under Medicare Part B.
    Section 482.102(b) also requires transplant centers to implement 
written living donor informed consent policies that inform the 
prospective living donor of all aspects of, and potential outcomes 
from, living donation. The centers must ensure that the prospective 
living donor is fully informed about: (1) The fact that communication 
between the donor and the transplant center will remain confidential; 
(2) the evaluation process; (3) the surgical procedure, including post-
operative treatment; (4) the availability of alternative treatments for 
the transplant recipient; (5) the potential medical or psychosocial 
risk to the donor; (6) the national and transplant center-specific 
outcomes for recipients; and the national and center-specific outcomes 
for living donors, as data are available; (7) the possibility that 
future health problems related to the donation may not be covered by 
the donor's insurance and that the donor's ability to obtain health, 
disability, or life insurance may be affected; and (8) the donor's 
right to opt out of donation at any time during the donation process; 
and (9) the fact that if a transplant is not provided in a Medicare-
approved transplant center, it could affect the transplant recipient's 
ability to have his or her immunosuppressive drugs paid under Medicare 
Part B.
    We believe that all transplant centers currently have policies 
regarding informed consent. Although we acknowledge that some centers 
may need to review and revise their informed consent policies to 
satisfy the requirements for this section, we believe that the economic 
impact will be minimal.
    Section 482.102(c) requires a transplant center to notify patients 
placed on the center's waiting list of information about the center 
that could impact the patient's ability to receive a transplant should 
an organ become available, and what procedures are in place to ensure 
the availability of a transplant team. Section 482.102(c)(1) 
specifically requires a transplant center served by a single transplant 
surgeon or physician to inform patients placed on the center's waiting 
list of the potential unavailability of the transplant surgeon or 
physician and to indicate whether or not the center has a mechanism to 
provide an alternate transplant surgeon or transplant physician.
    In the public comments we received to the proposed rule, one 
commenter pointed out that complying with this requirement would entail 
the drafting of a letter by an administrator, approval by the surgeon, 
searching a database to identify appropriate patients, clerical or 
support resources to prepare and mail the letters, and the expense 
associated with actually mailing the letters. The commenter pointed out 
that this would be an extensive and unrealistic use of resources for 
short-term unavailability issues, such as the absence of the transplant 
surgeon.
    As discussed earlier in this preamble, this provision does not 
require that transplant centers inform waiting list patients on an 
ongoing basis about the short-term unavailability of a transplant 
surgeon, such as, when a transplant surgeon is on vacation. The 
provision simply requires that at the time a patient is placed on the 
waiting list, the patient must be informed about circumstances that 
could impact the patient's ability to receive a transplant and what 
procedures the transplant center has in place to address these 
circumstances. Clearly, this requirement is particularly important when 
a transplant center is served by a single surgeon. We expect that most 
transplant centers already provide this information to patients when 
they are placed on the waiting list. Thus, the economic impact for this 
requirement is minimal.
    Section 482.102(c)(2) requires that, at least 30 days before a 
transplant center's Medicare approval is terminated, either voluntarily 
or involuntarily, the center must inform patients on its waiting list 
of this fact and provide assistance to waiting list patients who choose 
to transfer to the waiting list of another Medicare-approved transplant 
center without loss of time accrued on the waiting list. The transplant 
center must also inform Medicare beneficiaries on the center's waiting 
list that Medicare will no longer pay for transplants performed at the 
center after the effective date of the center's loss of Medicare 
approval.
    Section 482.102(c)(3) requires that as soon as possible prior to a 
transplant center's voluntary inactivation, the center must inform 
patients on its waiting list and, as directed by the Secretary, provide 
assistance to waiting list patients who choose to transfer to the 
waiting list of another Medicare-approved transplant center without 
loss of time accrued on the waiting list as soon as possible.
    We expect that transplant centers would inform waiting list 
patients by mail. We estimate that it would require an administrator 
approximately 30 minutes to draft a letter. A secretary or other 
support staff person would copy and mail these letters to the 
individuals on the center's waiting list. Based on our estimate, the 
economic impact of performing these tasks would be $100.69 for each 
center.

[[Page 15270]]



  Total Burden Hours and Total Cost Estimate for Notifying Patients on a Center's Waiting List of a Transplant
                                       Center's Loss of Medicare Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Senior Administrator............................................         $ 92.31             .50         $ 46.16
Secretary.......................................................           21.81            2.50           54.53
                                                                 -----------------------------------------------
    Totals......................................................  ..............            3.00         100.69
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com

    In addition, the transplant center would incur costs for paper, 
envelopes, and postage. We estimate these costs to total $.55 per 
mailing. On average, each transplant center has 112 patients, so the 
total cost of mailing the letter to each waiting list patient would be 
approximately $61.60 (112 patients x $.55 = $61.60).
    As discussed in more detail below under Sec.  488.61, we believe 
that based upon the requirements contained in this final rule, up to 
two percent of transplant centers or approximately 10 centers may lose 
their Medicare approved status annually. If 10 centers annually lost 
their Medicare approved status, either voluntarily or involuntarily, 
the total cost estimate would be $1,622.90 ($100.69 salary cost 
estimate + $61.60 materials/postage cost estimate x 10 transplant 
centers = $1,622.90).

Section 482.104 Condition of Participation: Additional Requirements for 
Kidney Transplant Centers

    Section 482.104(a) requires kidney transplant centers to directly 
furnish transplantation and other medical and surgical specialty 
services required for the care of ESRD patients. The centers must have 
written policies and procedures for ongoing communications with the 
dialysis patients' local dialysis facilities. Section 482.104(b) states 
that the kidney transplant centers must also furnish inpatient dialysis 
services directly or under arrangement. In addition, Section 482.104(c) 
states that the centers must cooperate with the ESRD network designated 
for their geographic area, in fulfilling the terms of the Network's 
current statement of work.
    We believe that these requirements constitute standard practice for 
transplant centers. Thus, the activities required to comply with this 
section constitute a minimal economic impact.

Section 488.61 Special Procedures for Approval and Re-Approval of Organ 
Transplant Centers

    Section 488.61(a) requires transplant centers that are not 
Medicare-approved as of June 28, 2007 to submit a request to CMS for 
Medicare approval. Section 488.61(b) requires transplant centers, 
including kidney transplant centers, that are Medicare approved as of 
June 28, 2007 to submit a request for Medicare approval no later than 
December 26, 2007. The process for making the request for Medicare 
approval is the same for both types of transplant centers. (See Sec.  
488.61(b)(1).) The request for Medicare approval must be signed by a 
person authorized to represent the center (for example, a chief 
executive officer). The request must include the hospital's Medicare 
provider identification (I.D.) number; the name(s) of the designated 
primary transplant surgeon and primary transplant physician; and a 
statement from the OPTN that the center has complied with all data 
submission requirements.
    In the proposed rule, we estimated that each hospital would spend 
approximately 15 minutes to prepare and submit the request for Medicare 
approval to CMS. We did note that a hospital may have multiple 
transplant centers and, therefore, could be submitting more than one 
request for approval.
    We received public comments on the proposed rule that said we had 
underestimated the time required for a transplant center to apply for 
Medicare approval. One commenter emphasized that transplant centers 
regard applying for Medicare approval very seriously. The commenter 
also indicated that the preparation, approval, and submission of the 
request for Medicare approval could take days at many large 
institutions. After further analysis of the tasks and the personnel 
that would be involved in applying for Medicare approval, we agree with 
the commenters that 15 minutes significantly underestimates the time 
required to prepare the request, obtain the required center 
approval(s), and submit the request for Medicare approval to CMS. 
However, we disagree with the commenter that said it could take 
``days'' to accomplish all of the required tasks. Our analysis of the 
total cost estimate is discussed in detail below.
    We believe that accomplishing all of the tasks necessary for 
complying with Section 488.61(a) would involve the transplant program's 
medical director, an administrator, a transplant coordinator, and 
appropriate support/administrative staff. We estimate that it would 
take these individuals approximately the same amount of time as it 
would take the transplant center to notify CMS of a significant change 
in their program or approximately 2 burden hours.

     Total Annual Burden Hours and Total Annual Cost for a Transplant Center To Apply for Medicare Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................         $116.60             .50          $58.30
Senior Administrator............................................           92.31             .50           46.16
Transplant Coordinator..........................................           43.87             .75           32.90
Secretary.......................................................          $21.81             .25           $5.45
                                                                 -----------------------------------------------
    Totals......................................................  ..............            2.00         142.81
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com


[[Page 15271]]

    This final rule requires all currently-approved transplant centers 
that want to continue to provide services to Medicare beneficiaries to 
apply for initial approval. There are currently approximately 504 
Medicare-approved transplant centers. We believe that all 504 
transplant centers will submit letters requesting initial approval 
under the requirements of this final rule. In addition, based on our 
experience, we believe that approximately 10 new centers a year may 
apply for Medicare approval. Thus, we anticipate that 514 transplant 
centers will apply for Medicare in the first year following the 
effective date of this final rule.
    For the first year after the effective date of this final rule, the 
total cost estimate would be $73,404.34 (514 transplant centers x 
$142.81 = $73,404.34). For subsequent years, we anticipate that about 
10 transplant centers will request initial Medicare approval. For those 
subsequent years, the total cost estimate would be $1,428.10 (10 
transplant centers x $142.81 = $1,428.10).
    Section 488.61(d) allows transplant centers that have lost their 
Medicare approval to seek re-entry into the Medicare program at any 
time. If a center chooses to seek Medicare approval after losing it, 
the center must: (1) request initial approval using the procedures at 
Sec.  488.61(a); (2) be in compliance with Sec. Sec.  482.72 through 
482.104, except for Sec.  482.82 (Re-approval Requirements), at the 
time of the request for Medicare approval; and (3) submit a report to 
CMS documenting any changes or corrective action taken by the center as 
a result of the loss of its Medicare approval status.
    A transplant center would utilize resources to prepare and submit a 
request for approval to CMS pursuant to Sec.  488.61(a) and to prepare 
and submit a report to CMS documenting any changes or corrective action 
taken by the center as a result of the loss of its Medicare approval 
status. After further analysis of the tasks that would be involved and 
the personnel that would be needed, developing and submitting the 
requests and the report would involve the transplant program's medical 
director, an administrator, a transplant coordinator, and appropriate 
support or administrative staff. We also believe that it will require 
more time to request re-entry into the Medicare program due to the 
development of the report documenting any changes or corrective action 
taken by the center as a result of the loss of its Medicare approval 
status.
    During 2005 and 2006, only six centers voluntarily terminated their 
Medicare approval. Transplant centers have rarely had their Medicare 
approval status revoked involuntarily. However, this final rule has 
outcome requirements, clinical experience requirements, and process 
requirements that transplant centers must generally meet to obtain 
initial Medicare approval and to retain their approval. Considering 
these requirements, we anticipate that more centers may voluntarily 
terminate their Medicare approval status in order to give themselves 
time to correct any problems they may have in meeting these 
requirements. In addition, it may become more common for transplant 
centers to be involuntarily terminated from the Medicare program. 
Therefore, we estimate that, in any given year, up to two percent, or 
approximately 10, of the currently 504 Medicare-approved centers may 
lose their status annually and later seek to re-enter the program.
    Based on the above, we estimate that a transplant center complying 
with the requirements to apply for initial approval would incur a total 
cost of $329.50. In any given year, we anticipate that as many as 10 
centers may seek to re-enter the Medicare program. For these 10 
centers, the total cost estimate would be $ 3,295.00 ($329.50 per 
center to re-apply x 10 centers = $ 3,295.00).

    Total Annual Burden Hours and Total Annual Cost for Transplant Centers Seeking Re-Entry Into the Medicare
                                     Program After Loss of Medicare Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                Hourly wage   Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................         $116.60            1.00         $116.60
Senior Administrator............................................           92.31            1.00           92.31
Transplant Coordinator..........................................           43.87            2.50          109.68
Secretary.......................................................           21.81             .50           10.91
                                                                 -----------------------------------------------
    Totals......................................................  ..............            5.00          329.50
----------------------------------------------------------------------------------------------------------------
All salary information is from the salary.com Web site at http://hrsalarycenter.salary.com

    Thus, the estimated total economic impact for this section in the 
first year after this final rule becomes effective is $73,404.34 (514 
transplant centers x $142.81 = $73,404.34). For subsequent years, the 
estimated annual total economic impact is $4,723.10 ($1,428.10 + 
$3,295.00 = $4,723.10).
    Our estimate of the first-year economic impact on transplant 
centers to meet the requirements in this final rule are as follows:
     $215,928 for notification to CMS of significant changes to 
the center's transplant program.
     $95,882 annually for kidney transplant centers to notify 
dialysis facilities' of their patients' waiting list status.
     $311,172 to revise agreements with OPOs.
     $18,474,112 to develop and implement a QAPI program.
     $9,248,136 to provide a living donor advocate in those 
centers that perform living donor transplantations.
     $1,622 for centers that have lost their Medicare approval 
status to notify the patients on their waiting list.
     $73,404 in the first year of implementation of this final 
rule to apply for Medicare approval.

Summary of Direct Cost

    The overall first year economic impact of implementing the 
requirements in this final rule will be approximately $28,420,256, and 
the first year cost to each of the transplant centers will be an 
average of about $56,389 per transplant center. This figure includes 
the total compensation for all of the staff hours that were calculated.

Benefits and Effects of This Final Rule

    The primary economic benefit of this final rule lies with its 
potential to improve Medicare-approved transplant centers' 
effectiveness and efficiency and thus reduce the number of patient 
deaths and graft failures for patients who receive transplants at 
Medicare-approved facilities. We believe that implementing the 
requirements in this final rule will result in a decrease in patient 
deaths and graft failures.

[[Page 15272]]

However, it is difficult to estimate the percentage of that decrease. 
For some transplant centers, most of the requirements in this final 
rule are already standard practice. Other centers will need to make 
only minor improvements to their current processes and practices. And, 
some transplant centers will need to make substantial modifications to 
their processes and practices to be in compliance. In addition, while 
some requirements will probably have only a minor, if any, effect on 
patient outcomes, there are certain requirements that we believe have 
the potential to substantially improve patient outcomes. For example, 
Sec.  482.72(a) requires transplant centers to submit to the OPTN at 
least 95 percent of the required data on all transplants it has 
performed no later than 90 days after the due date established by the 
OPTN. Since this is already a requirement of the OPTN and the hospitals 
in which transplant centers are located must already belong to the 
OPTN, we do not anticipate that this requirement in the final rule will 
have any effect on patient outcomes. However, other requirements could 
have a substantial effect. Section 482.96 requires that transplant 
centers must develop, implement, and maintain a written, comprehensive, 
data-driven quality assessment and performance improvement (QAPI) 
program designed to monitor and evaluate performance of all 
transplantation services. These types of QAPI programs have the 
potential to substantially improve patient outcomes. Centers that do 
not have such QAPI programs currently could experience substantial 
improvements in their patient outcomes. However, since some centers are 
already complying with the QAPI requirement, as well as the other 
requirements in the final rule, we do not believe that the increase in 
improvement for all transplant centers will be substantial. Due to the 
current diversity in processes and procedures existing in transplant 
centers, we cannot calculate any percentage of decrease in patient 
deaths or graft failures to any degree of reasonable certainty. Thus, 
we will not be able to quantify the social benefits we believe will 
result from implementation of this final rule.
    The social benefits from the implementation of this regulation will 
result from both the lives saved and the decrease in graft failures. 
Organ failure is usually fatal within a short period of time. Patients 
with ESRD are an exception. Some ESRD patients can survive for many 
years on dialysis and many of those patients can do quite well. 
However, dialysis is quite demanding and requires a substantial 
commitment on the part of these patients and their families. Therefore, 
kidney transplantation offers these patients a substantially increased 
quality of life. In addition, graft failures for very seriously ill 
patients often require re-transplantation for the patient to survive 
for more than a short length of time. And, considering the significant 
shortage of transplantable organs, it is crucial for transplant centers 
to operate efficiently and provide the best quality of care to 
transplant recipients to optimize the use of the transplantable organs 
that are available.
    In addition to a decrease in patient deaths and graft failures, 
many of the requirements in this regulation should contribute to a 
higher quality of care for both transplant recipients and living 
donors. This increase in the quality of care will result in substantial 
social benefits. For example, the requirements for informed consent, 
donor management, a living donor advocate or living donor advocate 
team, and psychosocial evaluations of both potential transplant 
recipients and living donors should all lead to an improvement in the 
quality of care received by both transplant recipients and living 
donors. Based upon the above, we believe that the social benefits from 
the implementation of this final rule include:
     Increase in years of life gained.
     Improvements in quality of life, particularly for chronic 
kidney disease patients who can terminate dialysis.
     Resumption of work/volunteerism/productivity for some 
patients.
     An increase in the number of taxpayers (patients who 
return to work).
     An increase in family stability due to the life saved and 
improved health of a family member.
     An increase in access to dialysis as more patients receive 
kidney transplants.
     An increase in the number of patients who are transplanted 
due to the reduction in patients who need to be re-transplanted due to 
graft failures.
     Improved quality of care for both potential and actual 
transplant recipients and living donors.

Effects on the Medicare Program

    In addition to the social benefits discussed above, we can estimate 
a monetary benefit from a reduction in the number of kidney graft 
failures, which forces kidney transplant patients to return to dialysis 
for treatment. Medicare pays for kidney dialysis for the vast majority 
of dialysis patients in the United States.
    In 2003 (the most recent year for which complete data are 
available), there were 15,722 kidney (deceased or living donor) and 
kidney-pancreas transplants. Of the approximately 15,722 patients who 
received these transplants, 1-year graft survival data show that 1288 
(less than 10 percent) of kidney grafts failed. We do not have data to 
show how many of the transplants were performed at Medicare-approved 
facilities, but since all or nearly all kidney transplant centers are 
Medicare approved, we will assume that all 2003 kidney and kidney-
pancreas transplants were performed at Medicare-approved transplant 
centers. As stated above, we believe that the improvement in the number 
of graft failures will be modest. We estimate that the improvement 
could be from 1 to 3 percent. A 1 to 3 percent decrease in kidney graft 
failures would result in approximately 13 to 39 fewer graft failures in 
the first year after implementation of this regulation. Based on the 
median decrease of 2 percent, we can estimate that there could be as 
many as 26 fewer kidney graft failures.
    The 2003 average per person per year primary payer 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). 
Therefore, net health care cost savings would be $48,366 annually per 
patient and the cost savings for 26 patients would be $1,257,516 (26 
patients x $48,366 cost savings per patient = $1,257,516).
    It is important to note that re-transplantation of a kidney patient 
who experiences graft failure prevents a patient on the kidney waiting 
list from receiving a kidney and, thus, ending dialysis treatment. It 
is also important to note that while fewer graft failures will result 
in more patients receiving a first transplant (rather than a re-
transplant), we estimate that the number of organs available for 
transplantation will remain the same. Thus, we do not anticipate that 
Medicare will face increased costs because the number of transplants 
should remain approximately the same.
    We expect that the procedures for approval and re-approval 
contained in this final rule will have some economic impact on the 
Medicare program because CMS will need to survey all 504 transplant 
centers that are currently approved by Medicare if they wish to 
continue to provide services to Medicare beneficiaries. Furthermore,

[[Page 15273]]

under this final rule, all transplant centers must be re-approved every 
3 years, and some centers will be surveyed as part of our re-approval 
process. Thus, this final rule is likely to increase survey costs.
    Nevertheless, to the extent possible, we will minimize costs by 
prioritizing surveys based on transplant centers performance on the 
outcome requirements and by conducting surveys in the most efficient 
way possible. For example, all transplant centers located in the same 
hospital will be surveyed at the same time.
    In addition, since Medicare reimbursement rates are either directly 
or indirectly influenced by a hospital's costs, we may eventually 
increase Medicare reimbursement to transplant centers to cover some of 
the costs of their extra responsibilities. Medicare pays hospitals on a 
cost basis for certain ``organ acquisition costs''. Costs related to 
the requirement to have a donor advocate or donor advocate team are 
organ acquisition costs.
    Medicare generally reimburses hospitals for organ transplant costs 
for beneficiaries using diagnosis related groups (DRGs) in all States, 
except for Maryland. DRG payments are periodically re-weighted in a 
budget neutral fashion to increase payments for procedures that have 
costs that are growing at a faster rate than most other procedures. 
Therefore, it is possible that DRGs for organ transplants will increase 
and therefore offset some of the hospitals' costs under the various 
transplant DRGs.

Conclusion

    We believe that the requirements in this final rule will ensure 
that the organ transplants made available to patients are provided in a 
safe and effective manner. We also believe that this final rule will 
ensure that living donors receive the guidance and care that they 
deserve. We estimate that the first year cost of implementing this 
final rule is $28,420,256. The cost of implementation in subsequent 
years is estimated to be $9,566,291 annually.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 482

    Grant programs-health, Hospitals, Medicare, reporting and 
recordkeeping requirements.

42 CFR Part 488

    Administrative practice and procedure, Health facilities, Medicare, 
reporting and recordkeeping requirements.

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 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

Subpart U--Conditions for Coverage of Suppliers of End-Stage Renal 
Disease (ESRD) Services

0
1. The authority citation for part 405, Subpart U continues to read as 
follows:

    Authority: Secs. 1102, 1138, 1861, 1862(a), 1871, 1874, and 1881 
of the Social Security Act (42 U.S.C. 1302, 1320b-8, 1395x, 
1395y(a), 1395hh, 1395kk, and 1395rr), unless otherwise noted.


Sec.  405.2102  [Amended]

0
2. Section 405.2102 is amended by--
0
A. Removing the definitions for ``histocompatibility testing'' and 
``organ procurement''.
0
B. Amending the definition of ``ESRD facility'' by removing paragraph 
(a) and by re-designating paragraphs (b) through (e) as paragraphs (a) 
through (d).
0
C. Amending the definition of ``ESRD service'' by removing paragraph 
(a) and by re-designating paragraphs (b) and (c) as paragraphs (a) and 
(b).
0
D. Amending the definition of ``Qualified personnel'' by removing 
paragraph (g).


Sec. Sec.  405.2120 through 405.2124  [Removed]

0
3. Sections 405.2120 through 405.2124 are removed.


Sec.  405.2130  [Removed]

0
4. Section 405.2130 is removed.


Sec. Sec.  405.2170 and 405.2171  [Removed]

0
5. Section 405.2170 and 405.2171 are removed.

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
6. The authority citation for part 482 is revised to read as follows:

    Authority: Secs. 1102, 1871 and 1881 of the Social Security Act 
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.


0
7. Part 482 is amended by revising subpart E to read as follows:

Subpart E--Requirements for Specialty Hospitals

Sec.
482.68 Special requirements for transplant centers.
482.70 Definitions.

General Requirements for Transplant Centers

482.72 Condition of participation: OPTN Membership.
482.74 Condition of participation: Notification to CMS.
482.76 Condition of participation: Pediatric Transplants.

Transplant Center Data Submission, Clinical Experience, and Outcome 
Requirements

482.80 Condition of participation: Data submission, clinical 
experience, and outcome requirements for initial approval of 
transplant centers.
482.82 Condition of participation: Data submission, clinical 
experience, and outcome requirements for re-approval of transplant 
centers.

Transplant Center Process Requirements

482.90 Condition of participation: Patient and living donor 
selection.
482.92 Condition of participation: Organ recovery and receipt.
482.94 Condition of participation: Patient and living donor 
management.
482.96 Condition of participation: Quality assessment and 
performance improvement (QAPI).
482.98 Condition of participation: Human resources.
482.100 Condition of participation: Organ procurement.
482.102 Condition of participation: Patient and living donor rights.
482.104 Condition of participation: Additional requirements for 
kidney transplant centers.

Subpart E--Requirements for Specialty Hospitals


Sec.  482.68  Special requirements for transplant centers.

    A transplant center located within a hospital that has a Medicare 
provider agreement must meet the conditions of participation specified 
in Sec.  482.72 through Sec.  482.104 in order to be granted approval 
from CMS to provide transplant services.
    (a) Unless specified otherwise, the conditions of participation at 
Sec.  482.72 through Sec.  482.104 apply to heart, heart-lung, 
intestine, kidney, liver, lung, and pancreas centers.
    (b) In addition to meeting the conditions of participation 
specified in Sec.  482.72 through Sec.  482.104, a transplant center 
must also meet the conditions of participation specified in Sec.  482.1 
through Sec.  482.57.

[[Page 15274]]

Sec.  482.70  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 transplant centers, examples of adverse events 
include (but are not limited to) serious medical complications or death 
caused by living donation; unintentional transplantation of organs of 
mismatched blood types; transplantation of organs to unintended 
recipients; and unintended transmission of infectious disease to a 
recipient.
    End-Stage Renal Disease (ESRD) means that stage of renal impairment 
that appears irreversible and permanent, and requires a regular course 
of dialysis or kidney transplantation to maintain life.
    ESRD Network means all Medicare-approved ESRD facilities in a 
designated geographic area specified by CMS.
    Heart-Lung transplant center means a transplant center that is 
located in a hospital with an existing Medicare-approved heart 
transplant center and an existing Medicare-approved lung center that 
performs combined heart-lung transplants.
    Intestine transplant center means a Medicare-approved liver 
transplant center that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
    Network organization means the administrative governing body to the 
network and liaison to the Federal government.
    Pancreas transplant center means a Medicare-approved kidney 
transplant center that performs pancreas transplants alone or 
subsequent to a kidney transplant as well as kidney-pancreas 
transplants.
    Transplant center means an organ-specific transplant program (as 
defined in this rule) within a transplant hospital (for example, a 
hospital's lung transplant program may also be referred to as the 
hospital's lung transplant center).
    Transplant hospital means a hospital that furnishes organ 
transplants and other medical and surgical specialty services required 
for the care of transplant patients.
    Transplant program means a component within a transplant hospital 
(as defined in this rule) that provides transplantation of a particular 
type of organ.

General Requirements for Transplant Centers


Sec.  482.72  Condition of participation: OPTN membership.

    A transplant center must be located in a transplant hospital that 
is a member of and abides by the rules and requirements of the Organ 
Procurement and Transplantation Network (OPTN) established and operated 
in accordance with section 372 of the Public Health Service (PHS) Act 
(42 U.S.C. 274). The term ``rules and requirements of the OPTN'' means 
those rules and requirements approved by the Secretary pursuant to 
Sec.  121.4 of this title. No hospital that provides transplantation 
services shall be deemed to be out of compliance with section 
1138(a)(1)(B) of the Act or this section unless the Secretary has given 
the OPTN formal notice that he or she approves the decision to exclude 
the transplant hospital from the OPTN and also has notified the 
transplant hospital in writing.


Sec.  482.74  Condition of participation: Notification to CMS.

    (a) A transplant center must notify CMS immediately of any 
significant changes related to the center's transplant program or 
changes that could affect its compliance with the conditions of 
participation. Instances in which CMS should receive information for 
follow up, as appropriate, include, but are not limited to:
    (1) Change in key staff members of the transplant team, such as a 
change in the individual the transplant center designated to the OPTN 
as the center's ``primary transplant surgeon'' or ``primary transplant 
physician;'
    (2) A decrease in the center's number of transplants or survival 
rates that could result in the center being out of compliance with 
Sec.  482.82;
    (3) Termination of an agreement between the hospital in which the 
transplant center is located and an OPO for the recovery and receipt of 
organs as required by section 482.100; and
    (4) Inactivation of the transplant center.
    (b) Upon receiving notification of significant changes, CMS will 
follow up with the transplant center as appropriate, including (but not 
limited to):
    (1) Requesting additional information;
    (2) Analyzing the information; or
    (3) Conducting an on-site review.


Sec.  482.76  Condition of participation: Pediatric Transplants.

    A transplant center that seeks Medicare approval to provide 
transplantation services to pediatric patients must submit to CMS a 
request specifically for Medicare approval to perform pediatric 
transplants using the procedures described at Sec.  488.61 of this 
chapter.
    (a) Except as specified in paragraph (d) of this section, a center 
requesting Medicare approval to perform pediatric transplants must meet 
all the conditions of participation at Sec.  482.72 through Sec.  
482.74 and Sec.  482.80 through Sec.  482.104 with respect to its 
pediatric patients.
    (b) A center that performs 50 percent or more of its transplants in 
a 12-month period on adult patients must be approved to perform adult 
transplants in order to be approved to perform pediatric transplants.
    (1) Loss of Medicare approval to perform adult transplants, whether 
voluntary or involuntary, will result in loss of the center's approval 
to perform pediatric transplants.
    (2) Loss of Medicare approval to perform pediatric transplants, 
whether voluntary or involuntary, may trigger a review of the center's 
Medicare approval to perform adult transplants.
    (c) A center that performs 50 percent or more of its transplants in 
a 12-month period on pediatric patients must be approved to perform 
pediatric transplants in order to be approved to perform adult 
transplants.
    (1) Loss of Medicare approval to perform pediatric transplants, 
whether voluntary or involuntary, will result in loss of the center's 
approval to perform adult transplants.
    (2) Loss of Medicare approval to perform adult transplants, whether 
voluntary or involuntary, may trigger a review of the center's Medicare 
approval to perform pediatric transplants.
    (3) A center that performs 50 percent or more of its transplants on 
pediatric patients in a 12-month period is not required to meet the 
clinical experience requirements prior to its request for approval as a 
pediatric transplant center.
    (d) Instead of meeting all conditions of participation at Sec.  
482.72 through Sec.  482.74 and Sec.  482.80 through Sec.  482.104, a 
heart transplant center that wishes to provide transplantation services 
to pediatric heart patients may be approved to perform pediatric heart 
transplants by meeting the Omnibus Budget Reconciliation Act of 1987 
criteria in section 4009(b) (Pub. L. 100-203), as follows:
    (1) The center's pediatric transplant program must be operated 
jointly by the hospital and another facility that is Medicare-approved;
    (2) The unified program shares the same transplant surgeons and 
quality

[[Page 15275]]

improvement program (including oversight committee, patient protocol, 
and patient selection criteria); and
    (3) The center demonstrates to the satisfaction of the Secretary 
that it is able to provide the specialized facilities, services, and 
personnel that are required by pediatric heart transplant patients.

Transplant Center Data Submission, Clinical Experience, and Outcome 
Requirements


Sec.  482.80  Condition of participation: Data submission, clinical 
experience, and outcome requirements for initial approval of transplant 
centers.

    Except as specified in paragraph (d) of this section, and Sec.  
488.61 of this chapter, transplant centers must meet all data 
submission, clinical experience, and outcome requirements to be granted 
initial approval by CMS.
    (a) Standard: Data submission. No later than 90 days after the due 
date established by the OPTN, a transplant center must submit to the 
OPTN at least 95 percent of required data on all transplants (deceased 
and living donor) it has performed. Required data submissions include, 
but are not limited to, submission of the appropriate OPTN forms for 
transplant candidate registration, transplant recipient registration 
and follow-up, and living donor registration and follow-up.
    (b) Standard: Clinical experience. To be considered for initial 
approval, an organ-specific transplant center must generally perform 10 
transplants over a 12-month period.
    (c) Standard: Outcome requirements. CMS will review outcomes for 
all transplants performed at a center, including outcomes for living 
donor transplants, if applicable. Except for lung transplants, CMS will 
review adult and pediatric outcomes separately when a center requests 
Medicare approval to perform both adult and pediatric transplants.
    (1) CMS will compare each transplant center's observed number of 
patient deaths and graft failures 1-year post-transplant to the 
center's expected number of patient deaths and graft failures 1-year 
post-transplant using the data contained in the most recent Scientific 
Registry of Transplant Recipients (SRTR) center-specific report.
    (2) The required number of transplants must have been performed 
during the time frame reported in the most recent SRTR center-specific 
report.
    (3) CMS will not consider a center's patient and graft survival 
rates to be acceptable if:
    (i) A center's observed patient survival rate or observed graft 
survival rate is lower than its expected patient survival rate or 
expected graft survival rate; and
    (ii) All three of the following thresholds are crossed over:
    (A) The one-sided p-value is less than 0.05,
    (B) The number of observed events (patient deaths or graft 
failures) minus the number of expected events is greater than 3, and
    (C) The number of observed events divided by the number of expected 
events is greater than 1.5.
    (d) Exceptions. (1) A heart-lung transplant center is not required 
to comply with the clinical experience requirements in paragraph (b) of 
this section or the outcome requirements in paragraph (c) of this 
section for heart-lung transplants performed at the center.
    (2) An intestine transplant center is not required to comply with 
the outcome performance requirements in paragraph (c) of this section 
for intestine, combined liver-intestine or multivisceral transplants 
performed at the center.
    (3) A pancreas transplant center is not required to comply with the 
clinical experience requirements in paragraph (b) of this section or 
the outcome requirements in paragraph (c) of this section for pancreas 
transplants performed at the center.
    (4) A center that is requesting initial Medicare approval to 
perform pediatric transplants is not required to comply with the 
clinical experience requirements in paragraph (b) of this section prior 
to its request for approval as a pediatric transplant center.
    (5) A kidney transplant center that is not Medicare-approved on the 
effective date of this rule is required to perform at least 3 
transplants over a 12-month period prior to its request for initial 
approval.


Sec.  482.82  Condition of participation: Data submission, clinical 
experience, and outcome requirements for re-approval of transplant 
centers.

    Except as specified in paragraph (d) of this section, and Sec.  
488.61 of this chapter, transplant centers must meet all data 
submission, clinical experience, and outcome requirements in order to 
be re-approved.
    (a) Standard: Data submission. No later than 90 days after the due 
date established by the OPTN, a transplant center must submit to the 
OPTN at least 95 percent of the required data submissions on all 
transplants (deceased and living donor) it has performed over the 3-
year approval period. Required data submissions include, but are not 
limited to, submission of the appropriate OPTN forms for transplant 
candidate registration, transplant recipient registration and follow-
up, and living donor registration and follow-up.
    (b) Standard: Clinical experience. To be considered for re-
approval, an organ-specific transplant center must generally perform an 
average of 10 transplants per year during the re-approval period.
    (c) Standard: Outcome requirements. CMS will review outcomes for 
all transplants performed at a center, including outcomes for living 
donor transplants if applicable. Except for lung transplants, CMS will 
review adult and pediatric outcomes separately when a center requests 
Medicare approval to perform both adult and pediatric transplants.
    (1) CMS will compare each transplant center's observed number of 
patient deaths and graft failures 1-year post-transplant to the 
center's expected number of patient deaths and graft failures 1-year 
post-transplant using data contained in the most recent SRTR center-
specific report.
    (2) The required number of transplants must have been performed 
during the time frame reported in the most recent SRTR center-specific 
report.
    (3) CMS will not consider a center's patient and graft survival 
rates to be acceptable if:
    (i) A center's observed patient survival rate or observed graft 
survival rate is lower than its expected patient survival rate and 
graft survival rate; and
    (ii) All three of the following thresholds are crossed over:
    (A) The one-sided p-value is less than 0.05,
    (B) The number of observed events (patient deaths or graft 
failures) minus the number of expected events is greater than 3, and
    (C) The number of observed events divided by the number of expected 
events is greater than 1.5.
    (d) Exceptions. (1) A heart-lung transplant center is not required 
to comply with the clinical experience requirements in paragraph (b) of 
this section or the outcome requirements in paragraph (c) of this 
section for heart-lung transplants performed at the center.
    (2) An intestine transplant center is not required to comply with 
the outcome requirements in paragraph (c) of this section for 
intestine, combined liver-intestine, and multivisceral transplants 
performed at the center.
    (3) A pancreas transplant center is not required to comply with the 
clinical experience requirements in paragraph (b) of this section or 
the outcome

[[Page 15276]]

requirements in paragraph (c) of this section for pancreas transplants 
performed at the center.
    (4) A center that is approved to perform pediatric transplants is 
not required to comply with the clinical experience requirements in 
paragraph (b) of this section to be re-approved.

Transplant Center Process Requirements


Sec.  482.90  Condition of participation: Patient and living donor 
selection.

    The transplant center must use written patient selection criteria 
in determining a patient's suitability for placement on the waiting 
list or a patient's suitability for transplantation. If a center 
performs living donor transplants, the center also must use written 
donor selection criteria in determining the suitability of candidates 
for donation.
    (a) Standard: Patient selection. Patient selection criteria must 
ensure fair and non-discriminatory distribution of organs.
    (1) Prior to placement on the center's waiting list, a prospective 
transplant candidate must receive a psychosocial evaluation, if 
possible.
    (2) Before a transplant center places a transplant candidate on its 
waiting list, the candidate's medical record must contain documentation 
that the candidate's blood type has been determined.
    (3) When a patient is placed on a center's waiting list or is 
selected to receive a transplant, the center must document in the 
patient's medical record the patient selection criteria used.
    (4) A transplant center must provide a copy of its patient 
selection criteria to a transplant patient, or a dialysis facility, as 
requested by a patient or a dialysis facility.
    (b) Standard: Living donor selection. The living donor selection 
criteria must be consistent with the general principles of medical 
ethics. Transplant centers must:
    (1) Ensure that a prospective living donor receives a medical and 
psychosocial evaluation prior to donation,
    (2) Document in the living donor's medical records the living 
donor's suitability for donation, and
    (3) Document that the living donor has given informed consent, as 
required under Sec.  482.102.


Sec.  482.92  Condition of participation: Organ recovery and receipt.

    Transplant centers must have written protocols for validation of 
donor-recipient blood type and other vital data for the deceased organ 
recovery, organ receipt, and living donor organ transplantation 
processes. The transplanting surgeon at the transplant center is 
responsible for ensuring the medical suitability of donor organs for 
transplantation into the intended recipient.
    (a) Standard: Organ recovery. When the identity of an intended 
transplant recipient is known and the transplant center sends a team to 
recover the organ(s), the transplant center's recovery team must review 
and compare the donor data with the recipient blood type and other 
vital data before organ recovery takes place.
    (b) Standard: Organ receipt. After an organ arrives at a transplant 
center, prior to transplantation, the transplanting surgeon and another 
licensed health care professional must verify that the donor's blood 
type and other vital data are compatible with transplantation of the 
intended recipient
    (c) Standard: Living donor transplantation. If a center performs 
living donor transplants, the transplanting surgeon and another 
licensed health care professional at the center must verify that the 
living donor's blood type and other vital data are compatible with 
transplantation of the intended recipient immediately before the 
removal of the donor organ(s) and, if applicable, prior to the removal 
of the recipient's organ(s).


Sec.  482.94  Condition of participation: Patient and living donor 
management.

    Transplant centers must have written patient management policies 
for the transplant and discharge phases of transplantation. If a 
transplant center performs living donor transplants, the center also 
must have written donor management policies for the donor evaluation, 
donation, and discharge phases of living organ donation.
    (a) Standard: Patient and living donor care. The transplant 
center's patient and donor management policies must ensure that:
    (1) Each transplant patient is under the care of a 
multidisciplinary patient care team coordinated by a physician 
throughout the transplant and discharge phases of transplantation; and
    (2) If a center performs living donor transplants, each living 
donor is under the care of a multidisciplinary patient care team 
coordinated by a physician throughout the donor evaluation, donation, 
and discharge phases of donation.
    (b) Standard: Waiting list management. Transplant centers must keep 
their waiting lists up to date on an ongoing basis, including:
    (1) Updating of waiting list patients' clinical information;
    (2) Removing patients from the center's waiting list if a patient 
receives a transplant or dies, or if there is any other reason the 
patient should no longer be on a center's waiting list; and
    (3) Notifying the OPTN no later than 24 hours after a patient's 
removal from the center's waiting list.
    (c) Standard: Patient records. Transplant centers must maintain up-
to-date and accurate patient management records for each patient who 
receives an evaluation for placement on a center's waiting list and who 
is admitted for organ transplantation.
    (1) For each patient who receives an evaluation for placement on a 
center's waiting list, the center must document in the patient's record 
that the patient (and in the case of a kidney patient, the patient's 
usual dialysis facility) has been informed of his or her transplant 
status, including notification of:
    (i) The patient's placement on the center's waiting list;
    (ii) The center's decision not to place the patient on its waiting 
list; or
    (iii) The center's inability to make a determination regarding the 
patient's placement on its waiting list because further clinical 
testing or documentation is needed.
    (2) If a patient on the waiting list is removed from the waiting 
list for any reason other than death or transplantation, the transplant 
center must document in the patient's record that the patient (and in 
the case of a kidney patient, the patient's usual dialysis facility) 
was notified no later than 10 days after the date the patient was 
removed from the waiting list.
    (3) In the case of patients admitted for organ transplants, 
transplant centers must maintain written records of:
    (i) Multidisciplinary patient care planning during the transplant 
period; and
    (ii) Multidisciplinary discharge planning for post-transplant care.
    (d) Standard: Social services. The transplant center must make 
social services available, furnished by qualified social workers, to 
transplant patients, living donors, and their families. A qualified 
social worker is an individual who meets licensing requirements in the 
State in which he or she practices; and
    (1) Completed a course of study with specialization in clinical 
practice and holds a master's degree from a graduate school of social 
work accredited by the Council on Social Work Education; or
    (2) Is working as a social worker in a transplant center as of the 
effective date of this final rule and has served for at

[[Page 15277]]

least 2 years as a social worker, 1 year of which was in a 
transplantation program, and has established a consultative 
relationship with a social worker who is qualified under (d)(1) of this 
paragraph.
    (e) Standard: Nutritional services. Transplant centers must make 
nutritional assessments and diet counseling services, furnished by a 
qualified dietitian, available to all transplant patients and living 
donors. A qualified dietitian is an individual who meets practice 
requirements in the State in which he or she practices and is a 
registered dietitian with the Commission on Dietetic Registration.


Sec.  482.96  Condition of participation: Quality assessment and 
performance improvement (QAPI).

    Transplant centers must develop, implement, and maintain a written, 
comprehensive, data-driven QAPI program designed to monitor and 
evaluate performance of all transplantation services, including 
services provided under contract or arrangement.
    (a) Standard: Components of a QAPI program. The transplant center's 
QAPI program must use objective measures to evaluate the center's 
performance with regard to transplantation activities and outcomes. 
Outcome measures may include, but are not limited to, patient and donor 
selection criteria, accuracy of the waiting list in accordance with the 
OPTN waiting list requirements, accuracy of donor and recipient 
matching, patient and donor management, techniques for organ recovery, 
consent practices, patient education, patient satisfaction, and patient 
rights. The transplant center must take actions that result in 
performance improvements and track performance to ensure that 
improvements are sustained.
    (b) Standard: Adverse events. A transplant center must establish 
and implement written policies to address and document adverse events 
that occur during any phase of an organ transplantation case.
    (1) The policies must address, at a minimum, the process for the 
identification, reporting, analysis, and prevention of adverse events.
    (2) The transplant center must conduct a thorough analysis of and 
document any adverse event and must utilize the analysis to effect 
changes in the transplant center's policies and practices to prevent 
repeat incidents.


Sec.  482.98  Condition of participation: Human resources.

    The transplant center must ensure that all individuals who provide 
services and/or supervise services at the center, including individuals 
furnishing services under contract or arrangement, are qualified to 
provide or supervise such services.
    (a) Standard: Director of a transplant center. The transplant 
center must be under the general supervision of a qualified transplant 
surgeon or a qualified physician-director. The director of a transplant 
center need not serve full-time and may also serve as a center's 
primary transplant surgeon or transplant physician in accordance with 
Sec.  482.98(b). The director is responsible for planning, organizing, 
conducting, and directing the transplant center and must devote 
sufficient time to carry out these responsibilities, which include but 
are not limited to the following:
    (1) Coordinating with the hospital in which the transplant center 
is located to ensure adequate training of nursing staff and clinical 
transplant coordinators in the care of transplant patients and living 
donors.
    (2) Ensuring that tissue typing and organ procurement services are 
available.
    (3) Ensuring that transplantation surgery is performed by, or under 
the direct supervision of, a qualified transplant surgeon in accordance 
with Sec.  482.98(b).
    (b) Standard: Transplant surgeon and physician. The transplant 
center must identify to the OPTN a primary transplant surgeon and a 
transplant physician with the appropriate training and experience to 
provide transplantation services, who are immediately available to 
provide transplantation services when an organ is offered for 
transplantation.
    (1) The transplant surgeon is responsible for providing surgical 
services related to transplantation.
    (2) The transplant physician is responsible for providing and 
coordinating transplantation care.
    (c) Standard: Clinical transplant coordinator. The transplant 
center must have a clinical transplant coordinator to ensure the 
continuity of care of patients and living donors during the pre-
transplant, transplant, and discharge phases of transplantation and the 
donor evaluation, donation, and discharge phases of donation. The 
clinical transplant coordinator must be a registered nurse or clinician 
licensed by the State in which the clinical transplant coordinator 
practices, who has experience and knowledge of transplantation and 
living donation issues. The clinical transplant coordinator's 
responsibilities must include, but are not limited to, the following:
    (1) Ensuring the coordination of the clinical aspects of transplant 
patient and living donor care; and
    (2) Acting as a liaison between a kidney transplant center and 
dialysis facilities, as applicable.
    (d) Standard: Independent living donor advocate or living donor 
advocate team. The transplant center that performs living donor 
transplantation must identify either an independent living donor 
advocate or an independent living donor advocate team to ensure 
protection of the rights of living donors and prospective living 
donors.
    (1) The living donor advocate or living donor advocate team must 
not be involved in transplantation activities on a routine basis.
    (2) The independent living donor advocate or living donor advocate 
team must demonstrate:
    (i) Knowledge of living organ donation, transplantation, medical 
ethics, and informed consent; and
    (ii) Understanding of the potential impact of family and other 
external pressures on the prospective living donor's decision whether 
to donate and the ability to discuss these issues with the donor.
    (3) The independent living donor advocate or living donor advocate 
team is responsible for:
    (i) Representing and advising the donor;
    (ii) Protecting and promoting the interests of the donor; and
    (iii) Respecting the donor's decision and ensuring that the donor's 
decision is informed and free from coercion.
    (e) Standard: Transplant team. The transplant center must identify 
a multidisciplinary transplant team and describe the responsibilities 
of each member of the team. The team must be composed of individuals 
with the appropriate qualifications, training, and experience in the 
relevant areas of medicine, nursing, nutrition, social services, 
transplant coordination, and pharmacology.
    (f) Standard: Resource commitment. The transplant center must 
demonstrate availability of expertise in internal medicine, surgery, 
anesthesiology, immunology, infectious disease control, pathology, 
radiology, blood banking, and patient education as related to the 
provision of transplantation services.


Sec.  482.100  Condition of participation: Organ procurement.

    The transplant center must ensure that the hospital in which it 
operates has a written agreement for the receipt of organs with an OPO 
designated by the Secretary that identifies specific

[[Page 15278]]

responsibilities for the hospital and for the OPO with respect to organ 
recovery and organ allocation.


Sec.  482.102  Condition of participation: Patient and living donor 
rights.

    In addition to meeting the condition of participation ``Patients 
rights'' requirements at Sec.  482.13, the transplant center must 
protect and promote each transplant patient's and living donor's 
rights.
    (a) Standard: Informed consent for transplant patients. Transplant 
centers must implement written transplant patient informed consent 
policies that inform each patient of:
    (1) The evaluation process;
    (2) The surgical procedure;
    (3) Alternative treatments;
    (4) Potential medical or psychosocial risks;
    (5) National and transplant center-specific outcomes, from the most 
recent SRTR center-specific report, including (but not limited to) the 
transplant center's observed and expected 1-year patient and graft 
survival, national 1-year patient and graft survival, and notification 
about all Medicare outcome requirements not being met by the transplant 
center;
    (6) Organ donor risk factors that could affect the success of the 
graft or the health of the patient, including, but not limited to, the 
donor's history, condition or age of the organs used, or the patient's 
potential risk of contracting the human immunodeficiency virus and 
other infectious diseases if the disease cannot be detected in an 
infected donor;
    (7) His or her right to refuse transplantation; and
    (8) The fact that if his or her transplant is not provided in a 
Medicare-approved transplant center it could affect the transplant 
recipient's ability to have his or her immunosuppressive drugs paid for 
under Medicare Part B.
    (b) Standard: Informed consent for living donors. Transplant 
centers must implement written living donor informed consent policies 
that inform the prospective living donor of all aspects of, and 
potential outcomes from, living donation. Transplant centers must 
ensure that the prospective living donor is fully informed about the 
following:
    (1) The fact that communication between the donor and the 
transplant center will remain confidential, in accordance with the 
requirements at 45 CFR parts 160 and 164.
    (2) The evaluation process;
    (3) The surgical procedure, including post-operative treatment;
    (4) The availability of alternative treatments for the transplant 
recipient;
    (5) The potential medical or psychosocial risks to the donor;
    (6) The national and transplant center-specific outcomes for 
recipients, and the national and center-specific outcomes for living 
donors, as data are available;
    (7) The possibility that future health problems related to the 
donation may not be covered by the donor's insurance and that the 
donor's ability to obtain health, disability, or life insurance may be 
affected;
    (8) The donor's right to opt out of donation at any time during the 
donation process; and
    (9) The fact that if a transplant is not provided in a Medicare-
approved transplant center it could affect the transplant recipient's 
ability to have his or her immunosuppressive drugs paid for under 
Medicare Part B.
    (c) Standard: Notification to patients. Transplant centers must 
notify patients placed on the center's waiting list of information 
about the center that could impact the patient's ability to receive a 
transplant should an organ become available, and what procedures are in 
place to ensure the availability of a transplant team.
    (1) A transplant center served by a single transplant surgeon or 
physician must inform patients placed on the center's waiting list of:
    (i) The potential unavailability of the transplant surgeon or 
physician; and
    (ii) Whether the center has a mechanism to provide an alternate 
transplant surgeon or transplant physician.
    (2) At least 30 days before a center's Medicare approval is 
terminated, whether voluntarily or involuntarily, the center must:
    (i) Inform patients on the center's waiting list and provide 
assistance to waiting list patients who choose to transfer to the 
waiting list of another Medicare-approved transplant center without 
loss of time accrued on the waiting list; and
    (ii) Inform Medicare beneficiaries on the center's waiting list 
that Medicare will no longer pay for transplants performed at the 
center after the effective date of the center's termination of 
approval.
    (3) As soon as possible prior to a transplant center's voluntary 
inactivation, the center must inform patients on the center's waiting 
list and, as directed by the Secretary, provide assistance to waiting 
list patients who choose to transfer to the waiting list of another 
Medicare-approved transplant center without loss of time accrued on the 
waiting list.


Sec.  482.104  Condition of participation: Additional requirements for 
kidney transplant centers.

    (a) Standard: End stage renal disease (ESRD) services. Kidney 
transplant centers must directly furnish transplantation and other 
medical and surgical specialty services required for the care of ESRD 
patients. A kidney transplant center must have written policies and 
procedures for ongoing communications with dialysis patients' local 
dialysis facilities.
    (b) Standard: Dialysis services. Kidney transplant centers must 
furnish inpatient dialysis services directly or under arrangement.
    (c) Standard: Participation in network activities. Kidney 
transplant centers must cooperate with the ESRD Network designated for 
their geographic area, in fulfilling the terms of the Network's current 
statement of work.

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

Subpart A--General Provisions

0
8. The authority citation for part 488 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395(hh) unless otherwise noted).


Sec.  488.6  [Amended]

0
9. Section 488.6(a) is amended by adding ``transplant centers, except 
for kidney transplant centers;'' after ``psychiatric hospitals;'' but 
before ``SNFs.''

Subpart B--Special Requirements

0
10. Section 488.61 is added to subpart B to read as follows:


Sec.  488.61  Special procedures for approval and re-approval of organ 
transplant centers.

    For the purposes of this subpart, the survey, certification, and 
enforcement procedures described at 42 CFR part 488, subpart A apply to 
transplant centers, including the periodic review of compliance and 
approval described at Sec.  488.20.
    (a) Initial approval procedures for transplant centers that are not 
Medicare-approved as of June 28, 2007. A transplant center, including a 
kidney transplant center, may submit a request to CMS for Medicare 
approval at any time.
    (1) The request, signed by a person authorized to represent the 
center (for example, a chief executive officer), must include:
    (i) The hospital's Medicare provider I.D. number;

[[Page 15279]]

    (ii) Name(s) of the designated primary transplant surgeon and 
primary transplant physician; and,
    (iii) A statement from the OPTN that the center has complied with 
all data submission requirements.
    (2) To determine compliance with the clinical experience and 
outcome requirements at Sec.  482.80(b) and Sec.  482.80(c), CMS will 
review the data contained in the most recent OPTN Data Report and 1-
year patient and graft survival data contained in the most recent 
Scientific Registry of Transplant Recipient (SRTR) center-specific 
report.
    (3) If CMS determines that a transplant center has not met the data 
submission, clinical experience, or outcome requirements, CMS may deny 
the request for approval or may review the center's compliance with the 
conditions of participation at Sec.  482.72 through Sec.  482.76 and 
Sec.  482.90 through Sec.  482.104 of this chapter, using the 
procedures described at 42 CFR part 488, subpart A, to determine 
whether the center's request will be approved. CMS will notify the 
transplant center in writing whether it is approved and, if approved, 
of the effective date of its approval.
    (4) CMS will consider mitigating factors, including (but not 
limited to) the following in considering initial approval of a 
transplant center that does not meet the data submission, clinical 
experience, outcome requirements and other conditions of participation:
    (i) The extent to which outcome measures are met or exceeded;
    (ii) Availability of Medicare-approved transplant centers in the 
area; and
    (iii) Extenuating circumstances (e.g., natural disaster) that may 
have a temporary effect on meeting the conditions of participation.
    (iv) CMS will not approve any program with a condition-level 
deficiency. However, CMS may approve a program with a standard-level 
deficiency upon receipt of an acceptable plan of correction.
    (5) If CMS determines that a transplant center has met the data 
submission, clinical experience, and outcome requirements, CMS will 
review the center's compliance with the conditions of participation 
contained at Sec.  482.72 through Sec.  482.76 and Sec.  482.90 through 
Sec.  482.104 of this chapter using the procedures described at 42 CFR 
part 488, subpart A. If the transplant center is found to be in 
compliance with all the conditions of participation at Sec.  482.72 
through Sec.  482.104, except for Sec.  482.82 of this chapter (Re-
approval Requirements), CMS will notify the transplant center in 
writing of the effective date of its Medicare-approval. CMS will notify 
the transplant center in writing if it is not Medicare-approved.
    (6) A kidney transplant center may submit a request for initial 
approval after performing at least 3 transplants over a 12-month 
period.
    (7) Transplant centers will be approved for 3 years.
    (b) Initial approval procedures for transplant centers, including 
kidney transplant centers, that are Medicare approved as of June 28, 
2007.
    (1) A transplant center that wants to continue to be Medicare 
approved must be in compliance with the conditions of participation at 
Sec. Sec.  482.72 through 482.104 as of June 28, 2007 and submit a 
request to CMS for Medicare approval under the conditions of 
participation no later than December 26, 2007, using the process 
described in paragraph (a)(1) of the section.
    (2) CMS will determine whether to approve the transplant center, 
using the procedures described in paragraphs (a)(2) through (a)(5) of 
this section. Until CMS makes a determination whether to approve the 
transplant center under the conditions of participation at Sec. Sec.  
482.72 through 482.104, the transplant center will continue to be 
Medicare approved under the end stage renal disease (ESRD) conditions 
for coverage (CfCs) in part 405, subpart U of this chapter for kidney 
transplant centers or the pertinent national coverage decisions (NCDs) 
for extra-renal organ transplant centers, as applicable, and the 
transplant center will continue to be reimbursed for services provided 
to Medicare beneficiaries.
    (3) Once CMS approves a kidney transplant center under the 
conditions of participation, the ESRD CfCs no longer apply to the 
center as of the date of its approval. Once CMS approves an extra-renal 
organ transplant center under the conditions of participation, the NCDs 
no longer apply to the center as of the date of its approval.
    (4) If a transplant center that is Medicare approved as of June 28, 
2007 submits a request for approval under the CoPs at Sec. Sec.  482.72 
through 482.104 of this chapter but CMS does not approve the transplant 
center, or if the transplant center does not submit its request to CMS 
for Medicare approval under the CoPs by December 26, 2007, CMS will 
revoke the transplant center's approval under the conditions for 
coverage for kidney transplant centers or the national coverage 
decisions for extra-renal transplant centers, as applicable, and the 
transplant center will no longer be reimbursed for services provided to 
Medicare beneficiaries. CMS will notify the transplant center in 
writing of the effective date of its loss of Medicare approval.
    (c) Re-approval procedures. Once Medicare-approved, transplant 
centers, including kidney transplant centers, must be in compliance 
with all the conditions of participation for transplant centers at 
Sec.  482.72 through Sec.  482.104 of this chapter, except for Sec.  
482.80 (initial approval requirements) throughout the 3-year approval 
period.
    (1) Prior to the end of the 3-year approval period, CMS will review 
the transplant center's data in making re-approval determinations.
    (i) To determine compliance with the data submission requirements 
at Sec.  482.82(a) of this chapter, CMS will request data submission 
data from the OPTN for the previous 3 calendar years.
    (ii) To determine compliance with the clinical experience and 
outcome requirements at Sec.  482.82(b) and Sec.  482.82(c) of this 
chapter, CMS will review the data contained in the most recent OPTN 
Data Report and 1-year patient and graft survival data contained in the 
most recent SRTR center-specific reports.
    (2) If CMS determines that a transplant center has not met the data 
submission, clinical experience, or outcome requirements at Sec.  
482.82, the transplant center will be reviewed for compliance with 
Sec.  482.72 through Sec.  482.76 and Sec.  482.90 through Sec.  
482.104 of this chapter, using the procedures described at 42 CFR part 
488, subpart A.
    (3) If CMS determines that a transplant center has met the data 
submission, clinical experience, and outcome requirements at Sec.  
482.82, CMS may choose to review the transplant center for compliance 
with Sec.  482.72 through Sec.  482.76 and Sec.  482.90 through Sec.  
482.104 of this chapter, using the procedures described at 42 CFR part 
488, subpart A.
    (4) CMS will consider mitigating factors, including (but not 
limited to) the following in considering re-approval of a transplant 
center that does not meet the data submission, clinical experience, 
outcome requirements and other conditions of participation:
    (i) The extent to which outcome measures are met or exceeded;
    (ii) Availability of Medicare-approved transplant centers in the 
area; and
    (iii) Extenuating circumstances (e.g., natural disaster) that may 
have a temporary effect on meeting the conditions of participation.
    (iv) CMS will not approve any program with a condition-level 
deficiency. However, CMS may re-approve a program with a standard-level 
deficiency upon receipt of an acceptable plan of correction.

[[Page 15280]]

    (5) CMS will notify the transplant center in writing if its 
approval is being revoked and of the effective date of the revocation.
    (d) Loss of Medicare Approval. Centers that have lost their 
Medicare approval may seek re-entry into the Medicare program at any 
time. A center that has lost its Medicare approval must:
    (1) Request initial approval using the procedures described in 
Sec.  488.61(a);
    (2) Be in compliance with Sec. Sec.  482.72 through 482.104 of this 
chapter, except for Sec.  482.82 (Re-approval Requirements), at the 
time of the request for Medicare approval; and
    (3) Submit a report to CMS documenting any changes or corrective 
actions taken by the center as a result of the loss of its Medicare 
approval status.
    (e) Transplant Center Inactivity. A transplant center may remain 
inactive and retain its Medicare approval for a period not to exceed 12 
months during the 3-year approval cycle. A transplant center must 
notify CMS upon its voluntary inactivation as required by Sec.  
482.74(d) of this chapter.

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
11. The authority citation for part 498 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

Subpart A--General Provisions


Sec.  498.2  [Amended]

0
12. In Sec.  498.2, the definition of ``provider'' is amended by adding 
``transplant center'' after ``hospital'' the first time it appears.

(Catalog of Federal Domestic Assistance Program No. 13.773 
Medicare--Hospital Insurance Program; and No. 13.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: November 7, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.

    Approved: December 12, 2006.
Michael O. Leavitt
Secretary.

    Editorial Note: This document was received at the Office of the 
Federal Register on March 20, 2007.
[FR Doc. 07-1435 Filed 3-22-07; 4:00 pm]
BILLING CODE 4120-01-P