Transplant Regulatory Environment
Laura Murdock-Stillion, MHA, FACHE
The Ohio State University Wexner Medical Center
Disclosure
I have no relevant financial or nonfinancial relationships to disclose
ASTS
The Regulatory Oversight of
Transplantation…It’s Alphabet Soup!
Arm
CMS
Heart OPO
SRTS
Face
Lung
UNOS
NKF HHSKidney
NOTA AOPO
DOT
OSOTC
AST
Liver
OPTN
Hand
ACO
Joint Commission
HRSA
NATO
ACOT
National Organ Transplant Act (NOTA)
Organ Procurement Transplantation Network (OPTN)
United Network for Organ Sharing (UNOS)
Centers for Medicare and Medicaid Services (CMS)
Joint Commission (JC)
1984 National Organ Transplant Act (NOTA)
 Passed due to continuing shortage of organs
 Prohibits buying and selling of organs
 Creates Organ Procurement Transplantation Network
(OPTN)
 Establishes Scientific Registry of Transplant Recipients
(SRTR)
 Supervised by Department of Health & Human Services
 National Organ Transplant Act (NOTA)
Organ Procurement Transplantation Network (OPTN)
United Network for Organ Sharing (UNOS)
Centers for Medicare and Medicaid Services (CMS)
Joint Commission (JC)
Organ Procurement Transplant Network (OPTN)
 Standardizes criteria for placing patients on waiting list
 Standardizes criteria for defining patient’s medical status
 Creates allocation policies to use donated organs
efficiently
 Creates standards for collection of transplant data
 Defines governing structure of OPTN
Federal Government Role
in Transplantation
Department of Health and
Human Services (HHS)
Advisory Committee on
Transplantation (ACOT)
Other Agencies
Health Resources and
Services Administration
(HRSA)
Healthcare Systems
Bureau (HSB)
Division of
Transplantation
(DOT)
SRTR
Contractor
OPTN Contractor
(UNOS)
Centers for Medicare
& Medicaid Services
(CMS)
 National Organ Transplant Act (NOTA)
 Organ Procurement Transplantation Network (OPTN)
United Network for Organ Sharing (UNOS)
Centers for Medicare and Medicaid Services (CMS)
Joint Commission (JC)
UNOS Membership
 248 Transplant Centers
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Kidney - 238
Liver – 134 (72 Living)
Heart - 132
Heart/Lung - 50
Intestine - 43
Lung - 66
Pancreas Islet Cell - 23
Pancreas – 143
5,795 hospitals in
the US. Only 4%
have a transplant
program!
 58 Organ Procurement Organizations (OPOs)
 158 Histocompatibility Labs
 Other Organizations
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Role of UNOS
UNOS mission is to advance organ
availability and transplantation by uniting
and supporting our communities for the
benefit of patients through education,
technology and policy development.
UNOS Bylaws (last updated 2/2014)
Appendix A
General Membership Program Requirements
Appendix B
Membership Requirements – Organ Procurement Organizations
Appendix D
Membership Requirements – Transplant Hospitals and Programs
Appendix E
Membership Requirements - KIDNEY programs
Appendix F
Membership Requirements - LIVER programs
Appendix G
Membership Requirements - PANCREAS & ISLET programs
Appendix H
Membership Requirements – HEART program
Appendix I
Membership Requirements – LUNG program
Appendix K
Transplant Program in Activation, Withdrawal, Termination
Appendix L
Reviews, Actions, Due Process
Good Idea to be familiar with ALL the Bylaws (200+ pages)!
UNOS Policies (last updated 2/2014)
1.2
Surgeon verification of ABO prior to surgery
3.3.A
Double verification of ABO prior to listing
3.4.G
Patient’s ability to list at multiple centers
3.8
Removal of candidates from waiting list
1.4
Organ allocation during regional/national emergency
8.2
Consent for ECD prior to being listed
17
Transplantation of non resident aliens
18
Data submission requirements
18.1
General Submission of OPTN forms
18.1
Organ specific registration forms
UNOS Policies (continued)
18.1
Registration forms for living donors
18.1
Transplant recipient follow up forms
2.2
Deceased donor feedback form
18.1
Transplant recipient forms
18.3
Entering refusal codes
18.3
Validation of refusal codes
18.4A
Data submission standards
18.4A
UNOS audit
Good Idea to be familiar with ALL the Policies!
UNOS Audits
 Occur every 3 years
 Two scoring components: CLINICAL and
ADMINISTRATIVE
Program requirement
Clinical
Administrative
95%
90%
 Desk Audit occurs if program doesn’t meet
minimum scoring
 National Organ Transplant Act (NOTA)
 Organ Procurement Transplantation Network (OPTN)
 United Network for Organ Sharing (UNOS)
Centers for Medicare and Medicaid Services (CMS)
Joint Commission (JC)
Role of CMS
The Medicare Conditions of
Participation (COPs) are sets of
requirements for acceptable quality in
the operation of health care entities
and transplant programs.
CMS Conditions of Participation (COPs)
 In order to be granted approval from CMS to provide transplant
services, a transplant center must:
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Be located within a hospital that has a Medicare provider agreement
Meet the CoPs of this final rule
Meet all hospital CoPs
Must be a member of and abide by the approved rules and requirements
of the OPTN
 Must have a written OPO/Hospital agreement
 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 application, such as:
 Change in key staff members
 Decrease in the center’s volume or survival rates (Interpretive guidelines
will be developed that state what constitutes a significant enough
decrease in volume or survival that needs to be reported.)
 Termination of OPO/Hospital agreement
 Inactivation of the transplant center
CMS Conditions of Participation (COPs)
 To perform transplant services to both adult and pediatric
patients, each center must request separate Medicare
approval.
 A center that mostly performs adult transplants cannot be
approved to perform pediatric transplants if they lose
their approval to perform adult transplants.
 Except for lung transplants, CMS will review adult and
pediatric outcomes separately when a center requests
Medicare approval to perform pediatric transplants.
CMS Conditions of Participation (COPs)
 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
 Standard: Clinical experience
 Annual volume for the following types of transplant
centers is required:
 Heart, kidney, liver & lung transplant centers – 10 transplants
 No annual volume requirement for heart-lung, and pancreas
centers, and centers that primarily perform pediatric transplants
 Standard: Outcome measures
 A center’s (risk-adjusted) expected 1-year patient survival and 1year graft survival will be compared to its observed 1-year patient
survival and 1-year graft survival, based on the following noncompliance thresholds:
 O – E >3
 O/E >1.5
 1-sided p < 0.05
CMS Conditions of Participation (COPs)
 Standard: Patient selection
 Assure fair and nondiscriminatory distribution of organs
 Include a psychosocial evaluation
 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
 Standard: Living donor selection
 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
CMS Conditions of Participation (COPs)
 Standard: 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 is responsible for ensuring
medical suitability of donor organs for transplantation
into the intended recipient (living donor transplants
included)
o 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.
CMS Conditions of Participation (COPs)
 Standard: Patient and living donor
management
 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
 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
CMS Conditions of Participation (COPs)
 Standard: Waitlist management
 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 within 24 hours if
a patient receives a transplant or dies
 Standard: Patient records
 Centers must maintain up-to-date and accurate patient
management records for each patient. This includes notification
to patient (and patient’s usual dialysis facility if patient is a kidney
patient).
 Patient records must contain documentation of:
 Multidisciplinary care planning during the pre-transplant
period
 Multidisciplinary discharge planning for post-transplant care
CMS Conditions of Participation (COPs)
 Standard: Social Services
 Transplant centers must make available social
services, furnished by qualified social workers, to
transplant patients, living donors and their families.
 Standard: Nutritional Services
 Nutritional assessments and diet counseling services
furnished by a qualified dietitian must be available to
all transplant patients and living donors.
CMS Conditions of Participation (COPs)
 Standard: Quality Assessment and Performance
Improvement
 Transplant center must have a data drive QAPI program to
monitor and evaluate performance of all transplant services. It
must be:
o Transplant specific
o Comprehensive
o Incorporated into hospital plan
o Have objective measures
o Demonstrate that QAPI process makes improvements
CMS Conditions of Participation (COPs)
 Standard: Adverse Events
 Transplant center must establish and implement
written policies to address and document adverse
events that occur during any phase of an organ
transplant case.
CMS Conditions of Participation (COPs)
 Standard: Director of a transplant center
 Transplant center must be under the general supervision of a
qualified transplant surgeon or a qualified physician-director
 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
 Standard: Clinical transplant coordinator
 Transplant center must have a qualified clinical transplant
coordinator to ensure the continuity of care of patients and living
donors throughout transplantation and donation
CMS Conditions of Participation (COPs)
 Standard: Social services
 The transplant center must make available social services,
furnished by qualified social workers, to transplant patients, living
donors, and their families
 Standard: Nutritional services
 Nutritional assessments and diet counseling services furnished
by a qualified dietitian must be available to all transplant patients
and living donors
 Standard: Independent living donor advocate or
living donor advocate team
 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.
 This person or team must not be involved in transplantation
activities on a routine basis.
CMS Conditions of Participation (COPs)
 Standard: Informed consent for transplant patients
 Centers must have written policies for the informed consent process
 Documentation must be present that shows a patient was informed of
the following:
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Evaluation process
Surgical procedure
Alternative treatments
Potential medical or psychosocial risks
National & center-specific outcomes from the most recent SRTR centerspecific 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
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
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
 Similar guidelines apply to living donors
CMS Conditions of Participation (COPs)
 Standard: End stage renal disease
 Kidney transplant centers must furnish directly
transplantation and other medical and surgical
specialty services required for the care of ESRD
patients
 Kidney transplant centers must furnish inpatient
dialysis services directly or under arrangement
 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
 Transplant centers that meet all data submission, clinical
experience, outcome, and process requirements will be
approved for 3 years
 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
 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
 Under these new guidelines, transplant centers will have
the same appeal rights as other Medicare providers
CMS Audits
 Occur every 3 years potentially transitioning to 5 years
 Focused QAPI (fQAPI) component – newly introduced
 Evaluation methodology
 Consequences of not meeting COPs
 Mitigating Factors
 Systems Improvement Agreement (SIA) process
CMS Mitigating Factor Process
 Transplant program may request CMS consider
mitigating factors for program that does not meet one or
more of COPs.
 General areas that are reviewed to determine if a
program can be approved based on mitigating factors
include (but are not limited to):
 Extent to which outcome measures are met or
exceeded
 Availability of Medicare-approved transplant centers in
the area
 Extenuating circumstances that may have a temporary
effect on meeting the COPs
CMS SIA process
 Process designed to perform an in-depth program
review for both outcomes and processes
 Designed to safeguard the health and safety of
transplant recipients and living donors to promote
sustained compliance with the Conditions of
Participation
Your Role …
 Remember these are UNANNOUNCED!
 The following groups will be interviewed:
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Transplant Director
Transplant Surgeon
Transplant Physician
Staff nurse
Transplant Coordinators
Social Workers
Dietician/Nutritionist
Pharmacist
Independent Living Donor Advocate
Staff hired within last 3 months
 National Organ Transplant Act (NOTA)
 Organ Procurement Transplantation Network (OPTN)
 United Network for Organ Sharing (UNOS)
 Centers for Medicare and Medicaid Services (CMS)
Joint Commission (JC)
Role of JC
Role of JC
Role of JC
Role of JC
Role of JC
Compliance & Continuity of Care in
Transplantation…Why is it important?
 Preoperative condition of patient on waitlist impacts
outcomes
 Outcomes are tracked by federal regulatory agencies
and CMS
 These agencies have expectations at 1 and 3 years
for survival which is reflective of follow-up care
 Lapses in perioperative and follow-up care WILL
have significant financial impact on hospital and
professional reimbursement
Keys to Success
 Understand OPTN,CMS, OSOTC/ODH, JC requirements
 Accurate data submission = appropriate risk adjustment
 Quality Assessment and Process Improvement (QAPI)
program = fix problems in real time
 Do Good work - no replacement for good patient
selection, appropriate donor management & selection,
outstanding surgical/medical expertise and
comprehensive follow-up
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