[Federal Register: March 30, 2007 (Volume 72, Number 61)]
[Rules and Regulations]
[Page 15197-15280]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr07-10]
[[Page 15197]]
-----------------------------------------------------------------------
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
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
[[Page 15198]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 15201]]
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 http://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
�����������������������������������������������������������������
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
�����������������������������������������������������������������
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,
carolyn_lovett@omb.eop.gov. 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