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

Transplant Regulatory EnvironmentLaura 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

CM

S SRTS UNOS

HRSADOT

HHS

AS

TS

AST

OP

TN

ACOTACO

OPO

AOPO

NATONKF

OSOTC

HeartLung

Kidney

Join

t C

omm

issi

on

Face

Liver

Hand

Arm

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






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 AgenciesHealth 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)






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

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5,795 hospitals in the US. Only 4% have a transplant program!

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 DMembership Requirements – Transplant Hospitals and Programs

Appendix E Membership Requirements - KIDNEY programs

Appendix F Membership Requirements - LIVER programs

Appendix GMembership Requirements - PANCREAS & ISLET programs

Appendix HMembership 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)!

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 (last updated 2/2014)

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 Policies (continued)

Occur every 3 years

Two scoring components: CLINICAL and ADMINISTRATIVE

Desk Audit occurs if program doesn’t meet minimum scoring

UNOS Audits

Clinical Administrative

Program requirement 95% 90%






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


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)

oThe 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.


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


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 specifico Comprehensiveo Incorporated into hospital plano Have objective measureso Demonstrate that QAPI process makes improvements


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.


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


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


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

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 Audits

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






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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Documents

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