Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants, 15198-15280 [07-1435]
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Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules and Regulations
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 ReApproval of Transplant Centers To
Perform Organ Transplants
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
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
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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 § 488.5 of the
regulations, hospitals that are accredited
by the Joint Commission on
Accreditation of Healthcare
Organizations (JCAHO) or the American
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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
§ 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.
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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 ‘‘Medicareapproved 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 recertification; (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
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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 Medicareapproved lung center that performs
combined heart-lung transplants.
Intestine centers are those Medicareapproved 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 Reapproval 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 reapproval 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
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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 reapproval 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
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need for kidney dialysis services and retransplantation 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 Medicareapproved 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
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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 bylaws
for transplant centers
Comments
Main focuses of CMS requirements.
• Regulatory oversight of transplant centers.
• Patient care & transplant services furnished
to beneficiaries.
• Relationship with transplant centers based
on Provider Agreement & Medicare reimbursement.
• Medicare approval & re-approval based on
compliance with Conditions of participation
(CoPs).
• Provider responsibilities.
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CMS requirements
Part 121 sets forth the governing structure of
the OPTN and sets standards for availability
of organ transplantation data. Part 121 lays
out requirements for transplant program in
hospitals at §§ 121.9 and 121.11(b)(1)(C)
(defined as OMB-approved OPTN forms).
Main focuses of Part 121.
• Govern the operation of the OPTN which is
under contract with HRSA.
• Require OPTN to develop policies for its
members. However, 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.
Compliance with Part 121 ................................
OPTN membership requirements.
Main focuses of OPTN policies/Bylaws.
• Organ allocation.
• Credential of transplant surgeons/physicians.
• Relationship with transplant hospital members is collegial with the goal to help them
to improve performance.
• OPTN Membership application reviewed by
peer reviewers.
• Member obligations.
*Additional requirements for non-Medicare approved transplant programs.
Generic definitions in part 121 .........................
No comparable OPTN definitions.
§ 482.68 Special Requirements for transplant
centers.
In order to be granted approval from CMS to
provide transplant services, a transplant center must:
• Be located within a hospital that has a
Medicare provider agreement.
• Meet the CoPs of this final rule.
• Meet all hospital CoPs.
§ 482.70 Definitions.
CMS has specific definitions for certain types
of centers.
§ 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 approved rules and requirements of the OPTN established and operated in accordance with § 372 of the Public
Health Service (PHS) Act (42 U.S.C. section
274).
§ 482.74 Condition of participation: Notification to CMS.
A transplant center must notify CMS immediately of any significant changes related to
the center’s transplant program or changes
that would alter elements in the approval/reapproval application:
• A change in key staff members of the transplant team.
• A decrease in the center’s volume or survival
rates.
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• This rule now makes the data submission
requirements of OPTN a Condition of Participation.
• Transplant centers must comply with CoPs
to be reimbursed.
§ 121.9 Designated transplant program requirements.
• (a) To receive organs for transplantation, a
transplant program must be in a hospital
that is a member of the OPTN.
OPTN Bylaw Appendix B–3 .............................
CMS adopts the OPTN bylaw and adds more
requirements.
OPTN member programs must notify OPTN
immediately when a key person plans to
leave.
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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
CMS requirements
• 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.
§ 482.76 Condition of participation: Pediatric
Hospitals.
• 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.
§ 482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for INITIAL APPROVAL of transplant centers.
(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.
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(b) Standard: Clinical experience. We require
an annual volume for the following types of
transplant centers:
• Heart, intestine, liver & lung transplant
centers—10 transplants.
• Kidney transplant centers—at least 3
transplants.
• No annual volume requirement for heartlung, and pancreas centers, and centers
that primarily perform pediatric transplants.
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Comments
...........................................................................
No specific OPTN policy/bylaw for pediatric
transplant programs.
§ 121.11(b)(2) Reporting requirements. Member transplant hospitals must submit to the
Secretary information as the Secretary prescribes (OPTN forms).
§ 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.
No annual volume required by the OPTN.
However, it has definitions for ‘‘functionally
inactive’’ centers:
• No transplants performed in 3 months
in the case of kidney, liver, & heart
transplant programs.
• No transplants performed in 6 months
in the case of pancreas & lung programs.
By using the publicly available SRTR data for
outcome measures, CMS’s outcome complements Part 121.
CMS adopts the OPTN policy for the most
part.
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CMS requirements are straighter than OPTN
policy for the purpose of monitoring inactivity of centers.
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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
CMS requirements
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(c) Standard: Outcome measures .....................
• 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.
§ 482.82 Condition of participation: Data submission, clinical experience, and outcome requirements for RE-APPROVAL of transplant
centers.
(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 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 experience. We require
an annual volume for the following types of
transplant centers:
• Heart, intestine, kidney, liver & lung
transplant centers—10 transplants.
• No annual volume requirement for heartlung, and pancreas centers, and centers
that primarily perform pediatric transplants.
(c) Standard: Outcome measures .....................
• 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.
§ 482.90 Condition of participation: Patient
and living donor selection.
(a) Standard: Patient selection. Patient selection criteria must:
• Assure fair and non-discriminatory distribution of organs.
• Include a psychosocial evaluation.
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OPTN Bylaw Appendix B Attachment Survival
Rates.
• While the precise numerical criteria may be
selected by the Membership & Professional
service Committee, the initial criteria employed to identify programs with low patient/
graft survival rates will include the following
findings:
• O ¥ E >3.
• O/E >1.5.
• 1-sided p <0.05.
Comments
CMS adopts the OPTN bylaws to the extent
that the outcome measure standards and
the OPTN policies for survival rate criteria &
outcome methodology are essentially the
same in the assessment of a center’s outcomes. However, OPTN uses the survival
outcomes as flags for further investigation
while CMS uses them as criteria to make
approval & re-approval determinations.
Compliance with the OPTN’s survival rate criteria is not required for initial approval 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.
See Initial Approval ..........................................
See Initial Approval.
See Initial Approval ..........................................
See Initial Approval.
See Initial Approval ..........................................
See Initial Approval.
§ 121.8
CMS requirements complement OPTN policies.
Allocation of Organs ..........................
The OPTN has wait list policies for the purpose of organ allocation.
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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
CMS requirements
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• 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 selection. The living
donor 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.
§ 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.
When an intended transplant recipient is
known, the transplant center’s organ recovery team must review and compare donordata with the recipient blood type and other
vital information before organ recovery takes
place.
(b) Standard: Organ receipt.
• When an organ arrives at the center, the
transplanting surgeon and at least one licensed health care professional must verify
that the donor’s blood type and other vital information is compatible with transplantation
of the intended recipient prior to transplantation.
(c) Standard: Living donor transplantation.
• 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).
§ 482.94 Condition of participation: Patient
and 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 donor care. .....
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.
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Comments
No comparable OPTN policy/bylaw.
Policy 3.1 Organ Distribution: Definitions.
3.1.2 Transplant Center—The transplanting
surgeon is responsible for ensuring medical
suitability of donor organ for transplantation
into the potential recipient, including compatibility of donor and candidate by ABO
blood type.
Policy 3.1 Organ Distribution: Definitions.
CMS requirements complement OPTN policies.
CMS requirements complement OPTN policies.
3.1.2 Transplant Center—Upon receipt of an
organ, prior to implantation, the transplant
center is responsible for verifying the recorded donor ABO with the recorded ABO
of the intended recipient.
...........................................................................
No comparable OPTN policy/bylaw.
...........................................................................
No comparable OPTN policy/bylaw.
...........................................................................
No comparable OPTN policy/bylaw.
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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
CMS requirements
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
Comments
(b) Standard: Waitlist management. Transplant
centers must keep their waitlists up to date,
including:
• Updating waitlist patients’ clinical information on an ongoing basis.
• Removing patients from the center’s
waitlist 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 waitlist.
• Notifying the OPTN no later than 24
hours after a patient’s removal from the
center’s waitlist.
(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 waitlist and who is admitted for
organ transplantation. This includes notification to patient (and patient’s usual dialysis
facility if patient is a kidney patient) of:
• Patient’s placement on the center’s
waitlist; the center’s decision not to
place the patient on its waitlist; or the
center’s inability to make a determination regarding the patient’s placement
on its waitlist because further clinical
testing or documentation is needed.
• Removal from waitlist for reasons other
than transplantation or death within 10
days.
• Patient records must contain documentation of:
• Multidisciplinary patient care planning
during the pre-transplant period.
• Multidisciplinary discharge planning for
post-transplant care.
(d) Standard: Social services.
The transplant center must make available social services, furnished by qualified social
workers, to transplant patients, living donors,
and their families. Definitions for a qualified
social worker included.
OPTN Policies 3.2.3.1, 3.6.6 ............................
• Require transplant centers to immediately
remove transplant candidates that have received a transplant from a deceased donor,
or have died while awaiting a transplant,
from the center’s waitlist and from the
UNOS Patient Waiting List and to notify
UNOS within 24 hours of such removal.
CMS Requirements complement OPTN policies.
OPTN Bylaw Appendix B .................................
II.C.10 Transplant Programs: Patient Notification
Transplant programs must notify patients in
writing:
(i) within ten business days (a) of the patient’s being placed on the UNOS Patient Waiting List including the date the
patient was listed, or (b) of completion
of the patient’s evaluation as a candidate for transplantation, that the evaluation has been completed and that the
patient will not be placed on the UNOS
Patient Waiting List at this time, whichever is applicable; and
(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.
CMS adopts OPTN bylaw for the most part.
§ 121.9(a) Designated Transplant Program
Requirements
OPTN Bylaw Appendix B, Attachment I,
III.C.15 Transplant Programs: Social Support—Psychiatric and social support services must be available in transplant programs approved under 121.9(a)(2).
......................................................................
The OPTN bylaw does not define qualification
of a qualified social worker. CMS requirement complement OPTN bylaw.
sroberts on PROD1PC70 with RULES
(e) Standard: Nutritional services. Nutritional
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.
§ 482.96 Condition of participation: Quality
assessment and performance improvement
(QAPI).
A transplant center must have a data-driven
QAPI programs to monitor & evaluate performance of all transplantation services.
§ 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.
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No comparable OPTN policy/bylaw.
No comparable OPTN policy/bylaw.
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15205
CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
CMS requirements
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
Comments
(b) Standard: Transplant surgeon and physician.
• 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.
• Transplant surgeon is responsible for providing surgical services related to transplantation.
• Transplant physician is responsible for providing and coordinating transplantation care.
(c) Standard: Clinical transplant coordinator.
The transplant center must have a qualified
clinical transplant coordinator to ensure the
continuity of care of patients and living donors throughout transplantation and donation.
(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. The transplant
center must identify a multidisciplinary transplant team (composed of individuals from
medicine, nursing, nutrition, social services,
transplant coordination, and pharmacology)
and describe the responsibilities of each
member of the team.
OPTN Bylaw Appendix B defines the credential of a qualified transplant surgeon and
physician in 15 pages.
Each transplant center designated under 42
CFR 121.9(a)(2) must have on-site a qualified transplant surgeon.
The OPTN bylaw for credentials is too detailed for adoption in regulation.
CMS requirement for ‘‘immediate availability of
the primary transplant surgeon & physician’’
complement OPTN’s ‘‘on-site’’ bylaw.
OPTN Bylaw Appendix B: Requirement for a
Clinical Transplant Coordinator with defined
responsibilities.
CMS requirement complement the OPTN
bylaw.
§ 121.9(a) Designated Transplant Program
Requirements.
OPTN Bylaw Appendix B Attachment I.
Collaborative Support—Transplant 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.
§ 121.9(a) Designated Transplant Program
Requirements.
Bylaws Appendix B Attachment I.
Transplant Programs—Ancillary 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.
§ 121.9(a) Designated Transplant Program
Requirements.
Bylaws Appendix B Attachment I A transplant
program approved under 121.9(a)(2) must
have letters of agreement or contracts with
an OPO.
...........................................................................
CMS requirements complement Part 121 requirements and OPTN bylaw.
sroberts on PROD1PC70 with RULES
(f) Standard: Resource commitment. The transplant center must demonstrate 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.
§ 482.100 Condition of participation: Organ
procurement.
• Transplant center must ensure that transplant hospital has written agreement (with
delineated responsibilities for both parties)
with an OPO designated by the Secretary.
§ 482.102 Condition of participation: Patient
and living donor rights.
• In addition to meeting the requirements at
§ 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 have written policies
for the informed consent process.
• Each patient will be informed about:
—The evaluation process;
—The surgical procedure;
—Alternative treatments;
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...........................................................................
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CMS adopts the Part 121 requirements and
OPTN bylaw.
CMS requirement complement the OPTN
bylaw because the OPTN bylaw does not
require transplant centers to notify the
OPTN or CMS when an agreement with an
OPO is terminated.
No comparable OPTN policy/bylaw.
No comparable OPTN policy/bylaw.
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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
CMS requirements
sroberts on PROD1PC70 with RULES
—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 for living donors.
• Transplant centers must have written policies
for the informed consent process.
• Each living donor will be informed about:
—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 postop 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.
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Comments
...........................................................................
No comparable OPTN policy/bylaw.
CMS adopts many of the informed consent
elements contained in the Secretary’s Advisory Committee on Transplantation (ACOT)
Recommendations.
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15207
CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
CMS requirements
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
(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:
—The fact the center is served by a single
transplant surgeon or physician, the potential unavailability of the transplant
surgeon or physician, and whether or
not the center has a mechanism to provide an alternative transplant surgeon or
transplant physician that meets the hospital’s credentialing policies.
• At least 30 days before a center’s Medicare
approval is terminated, whether voluntarily or
involuntarily, the center must inform:
—Patients on the waiting list & provide assistance to waiting list patients who
choose to transfer to the waiting list of
another Medicare-approved center without loss of time accrued on the waiting
list; and
—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.
§ 482.104 Condition of participation: Additional requirements 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 ...................
§ 121.9 Designated Transplant Program Requirements.
(a) To receive organs for transplantation, a
transplant
program
approved
under
121.9(a)(2) agrees to promptly notify OPTN
& patients awaiting transplantation if it becomes inactive.
OPTN Bylaws Appendix B Attachment I—Criteria for Institutional Membership.
III.C Transplant programs—A transplant program served by a single surgeon or physician shall inform patients of this fact and
potential unavailability of 1 or both of 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.
CMS adopts Part 121 and OPTN bylaws.
...........................................................................
No comparable Part 121 requirements or
OPTN policy/bylaw for kidney transplant
centers.
Bylaws Appendix B—Criteria for Institutional
Membership.
Relocation and transfer of established programs is not addressed in CMS requirements.
sroberts on PROD1PC70 with RULES
No comparable CMS requirements ...................
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III.E Relocation and Transfer of Established
Programs.
Part 121.8 Allocation requirements of Organs.
OPTN Policy 3.0 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.
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Comments
The OPTN policies are all organ allocation/acceptance policies.
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CROSSWALK OF TRANSPLANT CENTER FINAL RULE, PART 121, & OPTN POLICIES AND BYLAWS—Continued
42 CFR Part 121, OPTN policies, and bylaws
for transplant centers
CMS requirements
§ 488.61 Special procedures for approval and
re-approval of organ transplant centers.
• Survey, certification, and enforcement procedures at 42 CFR part 488, subpart A, including the periodic review of compliance and
approval contained in § 488.20.
• Transplant centers that meet all data submission, clinical experience, outcome, and
process requirements will be approved for 3
years.
• Current Medicare-approved centers will continue to be Medicare approved after submitting applications and awaiting CMS’s decision for approval.
• At the end of 3-year approval period, CMS
will review transplant center’s data to determine compliance with data submission, clinical experience and outcome requirements at
§ 482.82.
• If a center is in compliance with § 482.82,
CMS may choose to review its compliance
with the rest of the CoPs.
• 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.
• Centers that have lost their Medicare approval may seek re-entry into the Medicare
program at any time, and the center must:
(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.
sroberts on PROD1PC70 with RULES
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.
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Comments
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.
§ 121.10(c)(1)(2) Enforcement
of
OPTN OPTN policies and bylaws are voluntary, until
rules.
approved (i.e., codified) by the Secretary. At
Sanctions for violations of non-mandatory polithis time, the Secretary has not approved or
cies or mandatory policies (w/o approval
published any OPTN policies and bylaws,
from the Secretary of DHHS) include:
except for data submission requirements.
• Warning, letter of admonition, or letter of For the first time, transplant centers have the
reprimand.
same appeal rights as other Medicare pro• Probation.
viders.
• Member Not in Good Standing.
Additional Sanctions (only for violation of mandatory policies):
• Suspension of member privileges.
• Termination of OPTN membership.
• Termination of Status as Designated Transplant Program, Termination of Participation
in Medicare/Medicaid, Termination of Reimbursement under Medicare/Medicaid.
The 3 additional sanctions can only be imposed by the Secretary.
§ 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.
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
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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
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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-a-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
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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
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15209
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
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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 reapproval 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 § 488.6. Since
‘‘transplant centers’’ are not specifically
identified in § 488.6, this final rule
inserts the language ‘‘transplant centers,
except for kidney transplant centers’’ in
§ 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 § 482.68)
We proposed that a transplant center
located within a hospital that has a
Medicare provider agreement must meet
the CoPs specified in § 482.72 through
§ 482.104 in order to be granted our
approval to provide transplant services.
We proposed that the CoPs specified
in § 482.72 through § 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
§ 482.1 through § 482.57.
We received no comments on this
section of the proposed regulation and
are finalizing it as proposed.
Definitions (Proposed § 482.70)
We proposed definitions for
‘‘transplant hospital,’’ ‘‘transplant
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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
§ 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 § 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, § 405.2102,
as well as §§ 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
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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 § 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 § 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.
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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 § 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 § 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 reapproval 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
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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
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and the OPTN, and/or conduct an onsite 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
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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 § 482.74 would be considered noncompliant 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 § 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
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for us to communicate such changes to
the OPTN.
Condition of Participation: Pediatric
Transplants (Proposed § 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 Medicareapproved to perform pediatric heart
transplants may also be approved by
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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
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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 12month 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
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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 § 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
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certain exceptions, which are discussed
below.
Proposed Data Submission
Requirements
We proposed at § 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 centerspecific 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 posttransplant 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
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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 posttransplant 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
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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
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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 OPTNrequired 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
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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
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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
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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 posttransplant 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
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survival rates, were significantly lower
than they are today. That is, 1-year riskadjusted 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, 1year 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 (nontransplant) 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,
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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
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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
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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 § 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 § 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 reapproval 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
§§ 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 § 488.61(a)(2) and
§ 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
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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 nonMedicare patients to transplant.
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
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.
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15217
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
§ 405.2122 as of this rule’s effective date
at § 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
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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
§ 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.
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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 § 488.61(e)), but the center
must notify us immediately of
significant changes in the number of
transplants performed, as required at
§ 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 § 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, standalone pediatric transplant programs’
ability to maintain resources and
expertise in transplantation.
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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.
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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 posttransplant 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 posttransplant, 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
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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’ comorbidities and more patients lost to
follow up. We believe that utilizing 1year survival data for approvals and reapprovals 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
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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
§ 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.
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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 reassess it.
We will not use these thresholds
simply to flag centers for further review
as suggested by some of the
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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 pretransplant evaluations, performing the
surgical procedure, and regulating posttransplant 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
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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 ReApprove 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 reapproval. The commenter recommended
that we defer any approval or reapproval 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. Noncompliance 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
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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/reapproval 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 multidimensional (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
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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
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15221
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 riskadjustment 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 1year 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
§ 482.98; and (3) the most recent SRTR
report on the center did not contain 1year 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 reevaluate the center when 1-year posttransplant data became available.
We asked for comments on our
proposal, as well as comments regarding
the frequency with which we should re-
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assess these new centers after they
receive initial Medicare approval.
Comment: Some commenters
supported the idea of approving new
centers based on 1-month posttransplant data. The three peer
reviewers did not object to the proposal
to review a new center’s 1-month posttransplant graft and patient survival
outcome; however, they believed that
reviewing a new center’s 3-month or 6month post-transplant data would
provide more relevant information. One
peer reviewer recommended an interim
approval of new centers based on a 1month post-transplant data review,
pending a subsequent review of 3month post-transplant data. Another
peer reviewer recommended the
comparison of projected 1-year posttransplant graft and patient survival
rates with the expected 1-year posttransplant 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 posttransplant 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 pretransplant 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 posttransplant graft and patient survival
rates in other established organ
transplant programs. The peer reviewer
said that having acceptable 1-year posttransplant 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
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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 naıve 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
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as a kidney center that seeks approval
as a pancreas center). The SRTR centerspecific reports indicate that the
performance of organ transplant centers
is not always consistent within a multicenter transplant hospital. Within the
same transplant hospital, some centers
may have outstanding outcomes while
some centers may have marginal or suboptimal 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 § 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 Medicareapproved 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 Medicareapproved 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 Medicareapproved 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
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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 reapproval 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
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Condition of Participation: Patient and
Living Donor Selection (Proposed
§ 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
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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 longterm 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 posttransplant 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 § 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
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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
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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
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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 § 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
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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 § 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
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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
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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 caseby-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
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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
§ 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 § 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
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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 nondiscriminatory. 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 § 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
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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
§ 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
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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
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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 § 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 donorrecipient 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 § 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 § 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
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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
§ 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
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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 pretransplant 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
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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’ preand 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 pretransplant 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-transplantrelated 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
§ 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 pretransplant 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
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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
§ 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 § 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
§ 482.94(c)(3)(ii).) As a general rule,
patients receive several months of posttransplant 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
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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 § 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
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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 longterm 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’ postdischarge 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’ postdischarge care, we expect a transplant
center to provide care, as needed, if a
living donor experiences donationrelated problems or complications postdischarge.
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
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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 § 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
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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 reevaluate 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 § 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
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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 § 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
UNetSM over the weekend for on-call
staff.
Response: UNetSM is available 24
hours a day, 7 days a week to the
transplant community. Transplant
centers need to provide access for oncall 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,
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transplant hospitals are expected to
maintain documentation of these
notifications and make the
documentation available to the OPTN.
As we proposed at § 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 § 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
§ 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 § 482.94(c) in this
final rule. Therefore, we are not
adopting the yearly notification
requirement we proposed at
§ 482.94(c)(2)(i).
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However, as we proposed at
§ 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
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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
§ 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
§ 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 posttransplant social services provided by
transplant centers and the potential for
Medicare reimbursement for the
services.
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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 § 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 § 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
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15231
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 § 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
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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 posttransplant 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
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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 § 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
§ 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.
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Condition of Participation: Quality
Assessment and Performance
Improvement (QAPI) (Proposed
§ 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 complaintdriven.
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
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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 transplantcenter-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
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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 § 482.96(a) in this final
rule.
As we proposed, this final rule
includes a separate QAPI standard at
§ 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
§ 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 transplantrelated 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.
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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 nontransplantation-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 § 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 physiciandirector 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
§ 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 § 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
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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
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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 § 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 currentlyemployed 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.
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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 crossreference 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 OPTNqualified 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
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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
§ 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.
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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)
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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
§ 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 predonation, 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
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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 ABTCqualified but not ABTC certified, yet
they perform their responsibilities well
and provide excellent patient care. The
commenters suggested accepting subspecialty 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
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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 § 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 § 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 § 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 § 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.
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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 § 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 § 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
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benefits of donation. One commenter
suggested that transplant centers should
be required only to offer the consulting
services of an in-house transplanteducated 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
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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 § 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.
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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.
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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, § 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
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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 § 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 § 482.98(f).
Condition of Participation: Organ
Procurement (Proposed § 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
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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
§ 482.100 to § 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
§ 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
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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 § 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 § 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 centerspecific 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
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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
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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 Medicareapproved facility.
Therefore, we have added a
requirement under the CoP for Patient
and Living Donor Rights at
§§ 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
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resources is available at
www.transplantliving.org. Although the
OPTN does not have any publications
specific to living donation (with the
exception of some limited information
published in the booklet titled ‘‘What
Every Patient Needs to Know’’) it has
posted extensive living donation
information on its Web site. Suggestions
that the OPTN adopt ACOT
recommendations are beyond the scope
of this rule.
Informed Consent
We are removing the proposed
requirement that transplant centers
inform transplant candidates of ‘‘the fact
that future health problems related to
the transplantation may not be covered
by the recipient’s insurance, and that
the recipient’s ability to obtain health,
disability, or life insurance may be
affected.’’ This language was included
in the proposed rule in the standard for
informed consent for transplant patients
at § 482.102(a)(6); similar language was
included in the standard for informed
consent for living donors at
§ 482.102(b)(7). It was intended to apply
only to living donors. Thus, it has been
removed at § 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
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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 § 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.
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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.
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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
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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 § 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 centerspecific outcomes as indicated in the
SRTR reports are already publicly
available at https://
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 riskadjustment factors when more data are
available.
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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.
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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
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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 reevaluating 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 § 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
§ 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
§ 482.22. Therefore, a requirement for an
alternate transplant surgeon or
transplant physician ‘‘that meets the
hospital’s credentialing policies’’ is
unnecessary.
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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
§ 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 30day 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.
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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
§ 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 § 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 § 482.104(a) that a kidney transplant
center must have written policies and
procedures for ongoing communication
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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 § 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
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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 §§ 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 § 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 (§ 488.6)
Under § 1865 of the Act and § 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 § 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
§ 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
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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
§ 488.61, will ultimately guide the
survey process.
Special Procedures for Approval and
Re-Approval of Organ Transplant
Centers (Proposed § 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 § 488.20. We would retain
§ 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
§ 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 § 482.80(b)(4) applied, the
center could ask the SRTR to prepare a
customized report of the center’s 1month patient and graft survival data for
the previous 1-year period. We or our
designee would determine compliance
with the outcome requirements
contained at § 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 § 482.80, we or
our designee would conduct a survey
and review the center’s compliance with
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the conditions of participation
contained at § 482.68 through § 482.76
and § 482.90 through § 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 § 482.68
through § 482.104, except for § 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 Medicareapproved, a transplant center would
have to be in compliance with all
conditions of participation for
transplant centers at § 482.68 through
§ 482.104, except for § 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 § 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 § 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 § 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 § 482.82, the transplant
center would be surveyed for
compliance with § 482.68 through
§ 482.76 and § 482.90 through § 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 reapproved, we or our designee would
notify the transplant center of the
effective date of the re-approval.
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(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 § 488.61(a). We
proposed that a center that lost its
Medicare approval would be required to
be in compliance with §§ 482.68
through 482.104, except for § 482.82
(Re-approval procedures), at the time of
the request for Medicare approval. We
proposed that a center seeking to reenter 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.
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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 § 488.61, if it fails to
meet the data, clinical experience, or
outcome requirements at § 482.80.
Instead, we will take a flexible approach
to our initial approval of transplant
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centers, as described at § 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 § 482.72
through § 482.76 and § 482.90 through
§ 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
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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.
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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,
§ 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 § 482.72 through
§ 482.76 and § 482.90 through § 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.’’
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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.
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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 §§ 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
§§ 482.72 through 482.104, using the
process described at § 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 Medicareapproved 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
§ 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
§ 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 §§ 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
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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 reapproval 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 reapproval. 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 reapprove 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.
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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
§ 488.61(c)(2), if we determine that a
transplant center has not met the data
submission, clinical experience, or
outcome requirements at § 482.82, the
transplant center will be reviewed for
compliance with the conditions of
participation at § 482.72 through
§ 482.76 and § 482.90 through § 482.104,
using the procedures described at 42
CFR part 488, subpart A. Under the final
rule at § 488.61(c)(3), if we determine
that a transplant center has met the data
submission, clinical experience, and
outcome requirements at § 482.82, we
may choose to review the transplant
center for compliance with the
conditions of participation at § 482.72
through § 482.76 and § 482.90 through
§ 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 Medicareapproved 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
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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 reapproval 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
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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-
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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.
sroberts on PROD1PC70 with RULES
(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 informationbased 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
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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
§ 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
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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 reapproval 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.
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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 Medicareapproved 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 reapproval, 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
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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 § 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 § 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 § 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 § 482.100(b) as
§ 482.74(a)(3) and revising newly
designated paragraph (a)(3).
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• 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 § 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 § 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 § 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 § 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 § 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
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centers.’’ (The appropriate revisions
regarding the clinical experience
requirements for approval and reapproval, including the special
procedures for approval and re-approval
described at § 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 § 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 § 482.80
paragraph (b)(1) (now (c)(1)) by
removing the words ‘‘ as long as the
center has 1-year post-transplant followup on at least 9 transplants of the
appropriate organ type.’’
• Revising proposed § 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 § 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
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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 § 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 heartlung 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 kidneypancreas 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 12month period prior to its request for
initial approval.’’
Amend § 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
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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 posttransplant follow-up on at least 9
transplants of the appropriate organ
type.’’
• Revising proposed § 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 § 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 heartlung 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 kidneypancreas 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.
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Amend § 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 § 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 § 482.94 ‘‘Condition of
participation: Patient and living donor
management’’ by—
• Removing the word ‘‘pretransplant’’ 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
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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 ‘‘pretransplant’’ 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 § 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
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dietitian with the Commission on
Dietetic Registration.
Amend § 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 § 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
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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 § 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 § 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 § 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 § 482.74(a)(3) and revising newly
designated § 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 § 482.102 ‘‘Condition of
participation: Patient and living donor
rights’’ by—
• Adding the words ‘‘Patient rights’’
to the condition statement to clarify that
§ 482.13 is the Patients rights CoP.
• Revising proposed § 482.102
paragraph (a) to read ‘‘Transplant
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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 § 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 § 482.102 paragraph (c)(1)(ii)
in order to clarify this provision.
• Revising proposed § 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
§ 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 Medicareapproved transplant center without loss
of time accrued on the waiting list.’’
Amend § 482.104 ‘‘Condition of
participation: Additional requirements
for kidney transplant centers’’ by—
• Revising proposed § 482.104
paragraph (a) by adding a new line that
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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 § 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 § 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 § 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 § 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 § 482.80(b) and (c), CMS
will review the data contained in the
most recent OPTN Data Report and 1year 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 § 482.72 through
§ 482.76 and § 482.90 through § 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
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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 § 488.61
paragraph (b)(1)(ii) (now (c)(1)(ii)) to
read ‘‘To determine compliance with
the clinical experience and outcome
requirements at § 482.82(b) and (c), CMS
will review the data contained in the
most recent OPTN Data Report and 1year 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 § 488.61
paragraph (b)(4) (now (c)(5)) to read:
‘‘CMS will notify the transplant center
in writing if its approval is being
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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 § 482.72 through
§ 482.104, except for § 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
§ 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
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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 posttransplant 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
§ 482.82, Condition of participation:
Data submission, clinical experience,
and outcome requirements for reapproval 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
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complying with this section would be a
total of 225 hours. The estimate of 900
transplant centers included nonMedicare 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 onehalf to two hours per change.
15253
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
Position
Hours required
per report
Hourly wage
Total cost
estimate for
each report
Total annual
burden hours
per center
(for 3 reports)
Total annual
cost estimate
per center
(for 3 reports
per year per
center)
Medical Director .................................................................
Senior Administrator ..........................................................
Transplant Coordinator ......................................................
Secretary ............................................................................
$116.60
92.31
43.87
21.81
.50
.50
.75
.25
$58.30
46.16
32.90
5.45
1.5
1.5
2.25
.75
$174.90
138.46
98.71
16.36
Totals ..........................................................................
........................
2.00
142.81
6.0
428.43
All salary information is from the salary.com Web site at https://hrsalarycenter.salary.com.
sroberts on PROD1PC70 with RULES
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
§ 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
§§ 482.72 through 482.74 and §§ 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 § 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, § 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
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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
§ 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 § 482.76(d) are not subject to the
PRA.
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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
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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-transplantrelated 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
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required data. As discussed above under
§ 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 § 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 § 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.
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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
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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, § 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
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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 § 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
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15255
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 Medicareapproved 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 × 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.
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TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO NOTIFY DIALYSIS FACILITIES OF THEIR
PATIENTS’ WAITING LIST STATUS
Position
Hourly wage
Burden hours
per event*
Cost estimate
per event*
Total annual
hours required
(for 4 events)
Total annual
cost estimate
(for 4 events)
Transplant Coordinator ........................................................
Secretary ..............................................................................
$ 43.87
21.81
2.00
.50
$87.74
10.90
8.0
2.0
$350.96
43.62
Totals ............................................................................
........................
2.50
98.64
10.0
394.58
All salary information is from the salary.com Web site at https://hrsalarycenter.salary.com.
*Each notification is an ‘‘event.’’
sroberts on PROD1PC70 with RULES
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 × 10 hours =
2,430) and the total cost complying with
this ICR is $95,882.94 (243 centers ×
$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
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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 § 488.61(a), each
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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
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11 hours to negotiate and draft a
mutually acceptable agreement that
15257
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
Position
Hourly wage
Total annual
hours required
Total annual
cost estimate
General Counsel or Attorney .......................................................................................................
Medical Director ...........................................................................................................................
Senior Administrator ....................................................................................................................
Transplant Coordinator ................................................................................................................
Secretary ......................................................................................................................................
$176.86
116.60
92.31
43.87
21.81
4.0
2.0
2.0
2.0
1.0
$707.44
233.20
184.62
87.74
21.81
Totals ....................................................................................................................................
........................
11.00
1,234.81
All salary information is from the salary.com Web site at https://hrsalarycenter.salary.com.
sroberts on PROD1PC70 with RULES
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 × 252
transplant centers = 2,268) and the total
cost estimate would be $311.172.12 (252
transplant centers × $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 centerspecific 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
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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
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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,
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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 Medicareapproved 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,
§ 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 Medicareapproved 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
Position
Hourly wage
Hours required
Total cost estimate
Senior Administrator ....................................................................................................................
Secretary ......................................................................................................................................
$92.31
21.81
.50
2.50
$46.16
54.53
Totals ....................................................................................................................................
........................
3.00
100.69
All salary information is from the salary.com Web site at https://hrsalarycenter.salary.com.
As discussed in more detail below
under section § 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 Medicareapproved 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 × 3 burden hours = 30
total burden hours) and the total annual
cost estimate would be $1,006.90
($100.69 cost estimate × 10 transplant
centers = $1,006.90).
sroberts on PROD1PC70 with RULES
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
§ 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
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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 § 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
PO 00000
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Fmt 4701
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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
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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 § 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
15259
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
Position
Hourly wage
Hours required
Total cost
estimate
Medical Director ...........................................................................................................................
Senior Administrator ....................................................................................................................
Transplant Coordinator ................................................................................................................
Secretary ......................................................................................................................................
$116.60
92.31
43.87
21.81
.50
.50
.75
.25
$58.30
46.16
32.90
5.45
Totals ....................................................................................................................................
........................
2.00
142.81
All salary information is from the salary.com Web site athttps://hrsalarycenter.salary.com.
sroberts on PROD1PC70 with RULES
This final rule requires all transplant
centers that are currently Medicareapproved 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 × 2 burden hours = 1,028 total
burden hours), and the total cost
estimate would be $73,404.34 (514
transplant centers × $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 × 2 burden hours = 20
total burden hours) and the total cost
estimate would be $1,428.10 (10
transplant centers × $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:
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(1) Request initial approval using the
procedures at § 488.61(a);
(2) Be in compliance with §§ 482.72
through 482.104, except for § 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 § 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
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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
§ 488.61(d) would require the same staff
as needed for § 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 × 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 × 10 centers =
$3,295.00).
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TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST FOR TRANSPLANT CENTERS SEEKING RE-ENTRY INTO THE
MEDICARE PROGRAM AFTER LOSS OF MEDICARE APPROVAL
Position
Hourly wage
Hours required
Total cost
estimate
Medical Director ...........................................................................................................................
Senior Administrator ....................................................................................................................
Transplant Coordinator ................................................................................................................
Secretary ......................................................................................................................................
$116.60
92.31
43.87
21.81
1.00
1.00
2.50
.50
$116.60
92.31
109.68
10.91
Totals ....................................................................................................................................
........................
5.00
329.50
All salary information is from the salary.com Web site at https://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
cost estimate
per TC
PRA requirement
Total annual
burden hours
(BHs)
per TC
§ 482.74—Notification to CMS of
Significant Changes.
$428.43
6.0
§ 482.94(c)(3)—Notification to Dialysis Facilities of Patients’ Waiting List Status.
§ 482.100—Development of Agreement Between T.C. and Each
OPO on Organ Recovery and Allocation 1.
394.58
10.0
1,234.81
11.0
§ 482.102(c)(2)—Notification of Patients on Waiting List of Loss of
Medicare Approval.
100.69
3.0
§ 488.61(a)—Application for Medicare Approval 2.
142.81
2.0
§ 488.61(d)—Application to
Enter Medicare Program.
Re-
329.50
5.0
Totals .......................................
2,630.82
37.0
Total annual cost estimate for ‘‘X’’
TCs
Total annual burden hours (BHs)
for ‘‘X’’ TCs
$215,928.72 for 504 TCs (currently
there are 504 Medicare approved TCs).
$95,882.94 for 243 TCs (currently
there are 243 Medicare-approved kidney TCs).
$311,172,12 for 252 TCs (we estimate that about 50 percent, or
252, TCs will need to re-draft
letters of agreements of contracts between themselves and
their designated OPOs).
$1,006.90 for 10 TCs (we estimate
that about 10 TCs would lose
their Medicare Approval each
year).
$73,404.34 for 514 TCs (first
year—all 504 currently Medicare-approved TCs would need
to apply and we estimate that 10
new TCs would also apply for a
total of 514 TCs applying for
Medicare approval in the first
year).
$3,295.00 for 10 TCs (we estimate
that 10 TCs who had lost their
Medicare approved status would
seek to re-enter the Medicare
Program each year)..
700,690.02 .....................................
3,024 BHs for 504 TCs (currently
there are 504 Medicare approved TCs).
2,430 BHs for 243 TCs (currently
there are 243 Medicare-approved kidney TCs).
2,772 BHs for 252 TCs (we estimate that about 50 percent, or
252, TCs will need to re-draft
letters of agreements of contracts between themselves and
their designated OPOs).
30 BHs for 10 TCs (we estimate
that about 10 TCs would lose
their Medicare Approval each
year).
1,028 BHs for 514 TCs (first
year—all 504 currently Medicare-approved TCs would need
to apply and we estimate that 10
new TCs would also apply for a
total of 514 TCs applying for
Medicare approval in the first
year).
50 BHs for 10 TCs (we estimate
that 10 TCs who had lost their
Medicare approved status would
seek to re-enter the Medicare
Program each year).
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 × 10 TCs) and the cost estimate will be $1,428.10
($142.81 × 10 TCs).
sroberts on PROD1PC70 with RULES
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,
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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,
PO 00000
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Fmt 4701
Sfmt 4700
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
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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, nonprofit 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.
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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 retransplantations. 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.
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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 Medicareapproved 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
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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 § 482.45(b)(1) of the hospital
CoPs, all transplant centers that are
currently Medicare-approved are
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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 § 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 Medicareapproved transplant centers, the total
annual cost estimate for complying with
this section is $215,928.72 ($428.43
annual cost estimate per center × 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
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specifically for Medicare approval to
perform pediatric transplants using the
procedures described in § 488.61,
Special procedures for approval and reapproval 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 § 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
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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
§ 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 § 482.72 through § 482.76 and
§ 482.90 through § 482.104. (See
§ 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
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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
§ 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 § 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 § 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 § 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 § 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 § 482.72
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through § 482.76 and § 482.90 through
§ 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 § 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 § 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
§ 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,
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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
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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 § 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 donorrecipient 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
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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
§ 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
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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, § 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 § 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
15265
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 × 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
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Position
Hourly wage
Transplant coordinator .........................................................
Secretary ..............................................................................
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Burden hours
per event
Cost estimate
per event
Total annual
hours required
(for 4 events)
2.00
.50
$87.74
10.90
8.0
2.0
$43.87
21.81
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Total annual
cost estimate
for 4 events)
$350.96
43.62
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TOTAL ANNUAL BURDEN HOURS AND TOTAL ANNUAL COST ESTIMATE TO NOTIFY DIALYSIS FACILITIES OF THEIR
PATIENTS’ WAITING LIST STATUS—Continued
Position
Hourly wage
Total ..............................................................................
Burden hours
per event
Cost estimate
per event
Total annual
hours required
(for 4 events)
2.50
98.64
10.00
........................
Total annual
cost estimate
for 4 events)
394.58
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All salary information is from the salary.com Web site at https://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 × $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
§ 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 § 482.94(d)(1). Thus, satisfying
this requirement would constitute a
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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 § 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
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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
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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
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19:11 Mar 29, 2007
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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 × 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 × 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.
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15267
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
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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 Medicareapproved 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 × 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 × .5 =
$40,562 × 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
sroberts on PROD1PC70 with RULES
Position
Hourly wage
Total annual
hours required
Total annual
cost estimate
General Counsel or Attorney .......................................................................................................
Medical Director ...........................................................................................................................
Senior Administrator ....................................................................................................................
Transplant Coordinator ................................................................................................................
Secretary ......................................................................................................................................
$176.86
116.60
92.31
43.87
21.81
4.0
2.0
2.0
2.0
1.0
$707.44
233.20
184.62
87.74
21.81
Totals ....................................................................................................................................
........................
11.00
1,234.81
All salary information is from the salary.com Web site at https://hrsalarycenter.salary.com
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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 ×
$1,234.81 = $311,172.12).
sroberts on PROD1PC70 with RULES
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 centerspecific 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
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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.
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15269
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 Medicareapproved 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.
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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
Position
Hourly wage
Hours required
Total cost
estimate
Senior Administrator ....................................................................................................................
Secretary ......................................................................................................................................
$ 92.31
21.81
.50
2.50
$ 46.16
54.53
Totals ....................................................................................................................................
........................
3.00
100.69
All salary information is from the salary.com Web site at https://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 ×
$.55 = $61.60).
As discussed in more detail below
under § 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 § 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
sroberts on PROD1PC70 with RULES
Position
Hourly wage
Hours required
Total cost
estimate
Medical Director ...........................................................................................................................
Senior Administrator ....................................................................................................................
Transplant Coordinator ................................................................................................................
Secretary ......................................................................................................................................
$116.60
92.31
43.87
$21.81
.50
.50
.75
.25
$58.30
46.16
32.90
$5.45
Totals ....................................................................................................................................
........................
2.00
142.81
All salary information is from the salary.com Web site at https://hrsalarycenter.salary.com
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This final rule requires all currentlyapproved 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 × $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 ×
$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 § 488.61(a); (2) be in
compliance with §§ 482.72 through
482.104, except for § 482.82 (Reapproval 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
§ 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 reentry 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
15271
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 × 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
Position
Hourly wage
Hours required
Total cost
estimate
Medical Director ...........................................................................................................................
Senior Administrator ....................................................................................................................
Transplant Coordinator ................................................................................................................
Secretary ......................................................................................................................................
$116.60
92.31
43.87
21.81
1.00
1.00
2.50
.50
$116.60
92.31
109.68
10.91
Totals ....................................................................................................................................
........................
5.00
329.50
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All salary information is from the salary.com Web site at https://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 ×
$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.
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• $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
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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 Medicareapproved facilities. We believe that
implementing the requirements in this
final rule will result in a decrease in
patient deaths and graft failures.
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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,
§ 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
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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 retransplanted 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.
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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 Medicareapproved 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 Medicareapproved 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 endstage 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 ×
$48,366 cost savings per patient =
$1,257,516).
It is important to note that retransplantation 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,
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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.
42 CFR Part 488
I
Administrative practice and
procedure, Health facilities, Medicare,
reporting and recordkeeping
requirements.
Subpart E—Requirements for Specialty
Hospitals
42 CFR Part 498
Administrative practice and
procedure, Health Facilities, Health
professions, Medicare, reporting and
recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
I
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
Subpart U—Conditions for Coverage of
Suppliers of End-Stage Renal Disease
(ESRD) Services
1. The authority citation for part 405,
Subpart U continues to read as follows:
I
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.
§ 405.2102
[Amended]
2. Section 405.2102 is amended by—
A. Removing the definitions for
‘‘histocompatibility testing’’ and ‘‘organ
procurement’’.
I B. Amending the definition of ‘‘ESRD
facility’’ by removing paragraph (a) and
by re-designating paragraphs (b) through
(e) as paragraphs (a) through (d).
I C. Amending the definition of ‘‘ESRD
service’’ by removing paragraph (a) and
by re-designating paragraphs (b) and (c)
as paragraphs (a) and (b).
I D. Amending the definition of
‘‘Qualified personnel’’ by removing
paragraph (g).
I
I
§§ 405.2120 through 405.2124
3. Sections 405.2120 through
405.2124 are removed.
§ 405.2130
[Removed]
4. Section 405.2130 is removed.
sroberts on PROD1PC70 with RULES
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.
§§ 405.2170 and 405.2171
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[Removed]
I
I
[Removed]
5. Section 405.2170 and 405.2171 are
removed.
I
PART 482—CONDITIONS OF
PARTICIPATION FOR HOSPITALS
42 CFR Part 482
Grant programs-health, Hospitals,
Medicare, reporting and recordkeeping
requirements.
15273
6. The authority citation for part 482
is revised to read as follows:
I
Authority: Secs. 1102, 1871 and 1881 of
the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr), unless otherwise noted.
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7. Part 482 is amended by revising
subpart E to read as follows:
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
§ 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 § 482.72
through § 482.104 in order to be granted
approval from CMS to provide
transplant services.
(a) Unless specified otherwise, the
conditions of participation at § 482.72
through § 482.104 apply to heart, heartlung, intestine, kidney, liver, lung, and
pancreas centers.
(b) In addition to meeting the
conditions of participation specified in
§ 482.72 through § 482.104, a transplant
center must also meet the conditions of
participation specified in § 482.1
through § 482.57.
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§ 482.70
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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 Medicareapproved 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 Medicareapproved 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 kidneypancreas transplants.
Transplant center means an organspecific 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.
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General Requirements for Transplant
Centers
§ 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 § 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.
§ 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 § 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.
§ 482.76 Condition of participation:
Pediatric Transplants.
A transplant center that seeks
Medicare approval to provide
transplantation services to pediatric
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patients must submit to CMS a request
specifically for Medicare approval to
perform pediatric transplants using the
procedures described at § 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 § 482.72 through
§ 482.74 and § 482.80 through § 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 § 482.72 through
§ 482.74 and § 482.80 through § 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
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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
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§ 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 § 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 posttransplant 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
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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 heartlung 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.
§ 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 § 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
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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 organspecific 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 posttransplant 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 heartlung 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
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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
§ 482.90 Condition of participation: Patient
and living donor selection.
sroberts on PROD1PC70 with RULES
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 § 482.102.
§ 482.92 Condition of participation: Organ
recovery and receipt.
Transplant centers must have written
protocols for validation of donorrecipient blood type and other vital data
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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).
§ 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:
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(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-todate 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
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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.
sroberts on PROD1PC70 with RULES
§ 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.
§ 482.98 Condition of participation: Human
resources.
The transplant center must ensure
that all individuals who provide
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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
§ 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
§ 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 pretransplant, 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:
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(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.
§ 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
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responsibilities for the hospital and for
the OPO with respect to organ recovery
and organ allocation.
sroberts on PROD1PC70 with RULES
§ 482.102 Condition of participation:
Patient and living donor rights.
In addition to meeting the condition
of participation ‘‘Patients rights’’
requirements at § 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 centerspecific 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 1year 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;
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(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.
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§ 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
8. The authority citation for part 488
continues to read as follows:
I
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395(hh) unless otherwise noted).
§ 488.6
[Amended]
9. Section 488.6(a) is amended by
adding ‘‘transplant centers, except for
kidney transplant centers;’’ after
‘‘psychiatric hospitals;’’ but before
‘‘SNFs.’’
I
Subpart B—Special Requirements
10. Section 488.61 is added to subpart
B to read as follows:
I
§ 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
§ 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;
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(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 § 482.80(b) and
§ 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 § 482.72
through § 482.76 and § 482.90 through
§ 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
§ 482.72 through § 482.76 and § 482.90
through § 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 § 482.72
through § 482.104, except for § 482.82 of
this chapter (Re-approval
Requirements), CMS will notify the
transplant center in writing of the
effective date of its Medicare-approval.
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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 §§ 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 §§ 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 §§ 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
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15279
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 § 482.72 through
§ 482.104 of this chapter, except for
§ 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 reapproval determinations.
(i) To determine compliance with the
data submission requirements at
§ 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 § 482.82(b) and
§ 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 § 482.82, the
transplant center will be reviewed for
compliance with § 482.72 through
§ 482.76 and § 482.90 through § 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 § 482.82, CMS
may choose to review the transplant
center for compliance with § 482.72
through § 482.76 and § 482.90 through
§ 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 reapprove a program with a standard-level
deficiency upon receipt of an acceptable
plan of correction.
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(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 § 488.61(a);
(2) Be in compliance with §§ 482.72
through 482.104 of this chapter, except
for § 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
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the 3-year approval cycle. A transplant
center must notify CMS upon its
voluntary inactivation as required by
§ 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
11. The authority citation for part 498
continues to read as follows:
I
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
‘‘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.
Subpart A—General Provisions
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]
§ 498.2
BILLING CODE 4120–01–P
[Amended]
12. In § 498.2, the definition of
‘‘provider’’ is amended by adding
I
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]]>Agencies
[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Rules and Regulations]
[Pages 15198-15280]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1435]
[[Page 15197]]
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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
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Rules
and Regulations
[[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
