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

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

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) 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)

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 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

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 Desk Audit occurs if program doesn’t meet minimum scoring Clinical Administrative Program requirement 95% 90%

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: 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 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

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) 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: Transplant specific Comprehensive Incorporated into hospital plan Have objective measures 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: 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

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: 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 44