1. Transplant Regulatory Environment
Laura Murdock-Stillion, MHA, FACHE
The Ohio State University Wexner Medical Center

2. Disclosure
I have no relevant financial or nonfinancial relationships to disclose

3. The Regulatory Oversight of Transplantation…It’s Alphabet Soup!
NOTA
CMS
SRTS
UNOS
HRSA
DOT
HHS
ASTS
AST
OPTN
ACOT
ACO
OPO
AOPO
NATO
NKF
OSOTC
Heart
Lung
Kidney
Joint Commission
Face
Liver
Hand
Arm 3

4. 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)

5. 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

6. 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)

7. 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

8. Federal Government Role in Transplantation
Department of Health and Human Services (HHS)
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)
Advisory Committee on Transplantation (ACOT)

9. 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)

10. UNOS Membership 248 Transplant Centers
12/09/2009
UNOS Membership
248 Transplant Centers
Kidney - 238
Liver – 134 (72 Living)
Heart - 132
Heart/Lung - 50
Intestine - 43
Lung - 66
Pancreas Islet Cell - 23
Pancreas – 143
58 Organ Procurement Organizations (OPOs)
158 Histocompatibility Labs
Other Organizations
5,795 hospitals in the US. Only 4% have a transplant program!
UHCMC Transplant Institute

11. 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.

12. 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)!

13. 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

14. 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!

15. UNOS Audits Occur every 3 years
Two scoring components: CLINICAL and ADMINISTRATIVE
Desk Audit occurs if program doesn’t meet minimum scoring
Clinical
Administrative
Program requirement
95%
90%

16. 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)

17. 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.

18. CMS Conditions of Participation (COPs)
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
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

19. 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.

20. 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 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

21. 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

22. 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)
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.

23. 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

24. 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

25. 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.

26. 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:
Transplant specific
Comprehensive
Incorporated into hospital plan
Have objective measures
Demonstrate that QAPI process makes improvements

27. 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.

28. 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

29. 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.

30. 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:
Evaluation process
Surgical procedure
Alternative treatments
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
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

31. 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

32. 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

33. 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

34. 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

35. 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

36. Your Role … Remember these are UNANNOUNCED!
The following groups will be interviewed:
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

37. 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)

38. Role of JC

39. Role of JC

40. Role of JC

41. Role of JC

42. Role of JC

43. 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

44. 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 44