Regulators and Regulations: A Comprehensive Overview of CMS and OPTN Policies Presented To Course for Living Donor Teams May 25, 2016 By Gwen McNatt, RN, PhD, CNN, FNP-BC The View from the Bureaucratic Suite 1 2 Overview of the Regulators Peer/Member Organization Overview of Living Donor Requirements 3 SRTR 4 Discussion and Q&A Discussion A learned blockhead is a greater blockhead than an ignorant one Benjamin Franklin
Objectives The learner will be able to discuss relevant regulations regarding potential and actual living donors: Name the two regulators/regulatory bodies who regulation living donation Describe the role of the IDA per regulation Discuss the regulations regarding living donor evaluation Discuss the regulations regarding informed consent Discuss the regulations regarding patient care management Describe the requirements of donor follow-up U.S. Department of Health and Human Services Health Resources and Services (HRSA) Centers for Medicare & Medicaid Services (CMS)) UNOS/OPTN Allocation /Standards/Data Collection/Peer Review Policy-Driven Board of Directors/Committees Composed of Peers Supported by Staff Payment for transplant and procurement services for Medicare beneficiaries Congressional Regulation/Bureaucrat Interpretation -driven SRTR Outcomes Analysis and Publication Medicare ESRD Act (1972) Final Rule: Conditions of Participation for Transplant Centers (2007) UNOS By-Laws UNOS/OPTN By-Laws UNOS/OPTN Policies 13.0 &14.0
CMS Conditions of Participation (2007) Purpose: Rule sets forth clear expectations for safe, high quality transplant service delivery in Medicare-participating centers The nine most terrifying words in the English language are, 'I'm from the government and I'm here to help.'" Ronald Reagan It takes too many good deeds to build a good reputation, and only one bad one to lose it - Benjamin Franklin Main Elements of CMS COPs address: Structure Process Outcomes These are also the main three components of quality in healthcare Donabedian (2005)
CMS COP Overview: Structure Requirements: Located in Medicare participating hospital UNOS membership Sufficient resources such as medical specialists Availability of transplant physicians and surgeons Written agreement with Organ Procurement Organization (OPO) Provision of immunology and tissue typing services Availability of dialysis services Patient medical records requirements Written Policies/Procedures/Protocols CMS COP Overview: Structure Requirements: Multidisciplinary team with physician leadership Social Worker Dietitian Pharmacist Independent Donor Advocate Transplant Coordinator Financial Coordinator???
CMS COP Overview: Process requirements Volume requirements Evaluation and listing of patients Waitlist management Transplant event management ABO validation Organ Recovery & Receipt Discharge planning Informed consent Living donor evaluation, informed consent, event and discharge management Evidence of multidisciplinary care planning throughout transplant process Mandates IDA and Informed consent of living donors as well as psychosocial evaluation, standard selection criteria, management protocols CMS COP Overview: Process requirements (continued) QAPI process Initial education and continuing education for nurses and other staff Patient and dialysis unit notification Notification to CMS of key personnel or outcome changes Communication with dialysis units Participation in ESRD Network Data submission to OPTN
CMS CoP Final Rule Section Headings 482.68 Special requirements for transplant centers 482.72 OPTN membership 482.76 Pediatric transplants 482.80 Data submission, clinical experience and outcome requirements for the initial approval of transplant centers 482.82 Data submission, clinical experience and outcome requirements for the reapproval of transplant centers 482.90 Patient and living donor selection 482.92 Organ recovery and receipt 482.94 Patient and living donor management 482.96 Quality assessment and performance improvement (QAPI) 482.98 Human resources 482.100 Organ procurement 482.102 Patient and living donor rights 482.104 Additional requirements for kidney transplant centers 488.61 Special procedures for the approval and reapproval of organ transplant centers OPTN/UNOS Final Rule (2000) established the regulatory framework for the structure and framework of the OPTN The United Network for Organ Sharing (UNOS) currently holds the operational contract as the OPTN Mission: Our 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.
OPTN: Structure Found primarily in By-laws Proscribe structure for member organizations: OPOs Transplant Hospitals Histocompatibility Labs Also personnel requirements Primary physician Describe others OPTN: Processes Found primarily in Policies Change every six months! Policies cover: Organ procurement and organ offers Waitlist Deceased donor allocation Donor disease transmission KPD and Living Donation
UNOS/OPTN Policy 14 Section Headings Wow? That is pretty prescriptive! Very detailed requirements Policy 14: Living Donation 14.1 Required Protocols for Recovery Hospitals 14.2 Independent Living Donor Advocate (ILDA) Requirements 14.3 Informed Consent Requirements DITTO 14.4 Medical Evaluation Requirements for Living Donors 14.5 Psychosocial Evaluation Requirements for Living Donors 14.6 Registration and Blood Type Verification of Living Donors before Donation 14.7 Placement of Living Donor Organs 14.8 Packaging, Labeling, and Transporting of Living Donor Organs, Vessels, and Tissue Typing Materials 14.9 Reporting Requirements CMS: Data Submission Requirements Data Submission: 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)
UNOS/OPTN: Data Submission Requirements UNOS OPTN: 18.5.A Reporting Requirements after Living Kidney Donation: Donor status 60% of their living kidney donors who donate between February 1, 2013 and December 31, 2013 70% of their living kidney donors who donate between January 1, 2014 and December 31, 2014 80% of their living kidney donors who donate after December 31, 2014 OPTN UNOS OPTN: UNOS/OPTN: Data Submission Requirements 18.5.A Reporting Requirements after Living Kidney Donation: Donor status 1. Patient status 2. Working for income, and if not working, reason for not working 3. Loss of medical (health, life) insurance due to donation 4. Has the donor been readmitted since last LDR or LDF form was submitted? 5. Kidney complications 6. Maintenance dialysis 7. Donor developed hypertension requiring medication 8. Diabetes 9. Cause of death, if applicable and known
UNOS/OPTN: Data Submission Requirements UNOS OPTN: 18.5.A Reporting Requirements after Living Kidney Donation: Labs Required kidney laboratory data includes all of the following: 1. Serum creatinine 2. Urine protein UNOS/OPTN: Data Submission Requirements UNOS OPTN: 18.5.A Reporting Requirements after Living Liver Donation: Donor status and Labs Living liver donors who donate after September 1, 2014, as follows: Donor status on at least 80% of their living liver donors. Liver laboratory data for at least: 75% of their living liver donors on the 6 month LDF 70% of their living liver donors on the one year LDF
UNOS OPTN: UNOS/OPTN: Data Submission Requirements 18.5.A Reporting Requirements after Living Liver Donation: liver donor status: 1. Patient status 2. Cause of death, if applicable and known 3. Working for income, and if not working, reason for not working 4. Loss of medical (health, life) insurance due to donation 5. Hospital readmission since last LDR or LDF was submitted 6. Liver complications, including the specific complications: 1. Abscess 5. Incisional hernias due to donation surgery 2. Liver failure 6. Bile leak 3. Hepatic resection 4. Registered on the liver candidate waiting list UNOS OPTN: UNOS/OPTN: Data Submission Requirements 18.5.A Reporting Requirements after Living Liver Donation: liver donor labs: 1. Alanine aminotransferase 2. Alkaline phosphatase 3. Platelet count 4. Total bilirubin
CMS Requirements: Donor Selection Donor Selection Criteria Must be fair Must be ethical Must include psychosocial evaluation (SUCAM) Social, personal, housing, vocational, financial, and environmental supports; Understanding of the risks of donation; Coping abilities and strategies; Ability to adhere to a therapeutic regimen; and Mental health history, including substance or alcohol use or abuse and how it may impact the donor following the donation. Must be documented OPTN Requirements: Processes Donor Selection Criteria - Psychosocial(ABC) Must include psychosocial evaluation performed by a psychiatrist, psychologist, or masters prepared social worker, or licensed clinical social worker. Ability to make informed decision Behaviors - PHS Coercion/payment/pressure Dollars: Understands potential financial implications Employment status, occupation, health insurance status, living arrangements, and social support Fully understands risks for him/herself AND recipient Good mental health: Psychosocial mental health Substance abuse history Help needs education or interventions
CMS: SUCAM CMS VS OPTN Are they the Same? OPTN - ABCDEFGH Social, personal, housing, vocational, financial, and environmental supports; Understanding of the risks of donation; Coping abilities and strategies; Ability to adhere to a therapeutic regimen; and Mental health history: substance or alcohol use or abuse and how it may impact the donor following the donation. Ability to make informed decision PHS Behaviors Coercion/payment/pressure Dollars: Understands potential financial implications Employment status, occupation, health insurance status, living arrangements, and social support Fully understands risks for him/herself AND recipient Good mental health: Psychosocial mental health Substance abuse history Help needs education or interventions Donor Selection Process: OPTN CMS Evaluation Phase Medical Evaluation: Very prescriptive (CMS is NOT) CMS only need to have one and need to have multidisciplinary involvement General donor history: Cardiovascular HTN, Heart Lung Diabetes GI Autoimmune Medications including nephron/hepatotoxic and chronic pain medication Family history: Coronary artery disease Cancer Neurological GU Hematological Bleeding or clotting Cancer including melanoma Infections Allergies Evaluation for CAD
Donor Selection Process: OPTN Medical Evaluation: Social History: Occupation/employment status Health insurance status Living arrangements/social support Smoking/Substance Abuse Psyche, depression, suicide attempts PHS Behavior Physical Exam: Height/Weight/BMI Vital signs Examination of all major organ systems Donor Selection Process: OPTN Medical Evaluation: Lab and DX Testing: CBC w/platelets Blood type PT/INR/PTT Metabolic Blood Testing (chemistries) HCG QUANTITATIVE CXR ECG Cancer Screening Cervical Colon Prostate Colon Lung
Donor Selection Process: OPTN Medical Evaluation: Transmissible Disease Testing CMV EBV HIV Ab (within 28 days) HBV (within 28 days) HCV and HCV NAT (within 28 days) TB Endemic Disease Testing For your geographic area If PHS risk positive need HIV NAT or Ag/Ab Why do you suppose they stopped here? Donor Selection: Organ specific Kidney: Kidney-specific donor history Genetic renal disease Kidney disease, proteinuria, hematuria DM including gestational Stones Recurrent UTI Family history Kidney disease DM HTN Kidney Cancer
Donor Selection: Organ specific Kidney: Physical Exam 2 BPs or 24 hour BP monitoring Other metabolic Fasting glucose Fasting lipid profile OGTT or Hgb A1C in first degree DM relatives or high risk Other kidney tests UA Urine c&s if indicated Urinary protein and albumin excretion GFR Anatomic Assessment PCKD and other inherited testing protocol Stone panel if history Organ Specific - Liver Family history: Liver disease Clotting or bleeding disorders Lab Tests Hypercoagable state evaluation protocol Liver specific tests Hepatic function panel Ceruloplasmin w/ family h/o Wilson s disease Fe, IBC, ferritin Alpha A-1 antitrypsin if low phenotype Genetic and autoimmune protocols Liver biopsy protocol Anatomic Graft volume and remnant volume Vascular anatomy Steatosis
Donor Exclusions All: Less that 18 and cannot make informed decision HIV positive (unless HIV positive recipient) Active malignancy or incompletely treated High suspicion of coercion High suspicion of illegal financial exchange Evidence of acute, symptomatic infection Uncontrolled psychiatric condition Kidney: Uncontrolled HTN or w/ evidence of end organ damage DM Donor Exclusions Liver: HCV RNA Positive HBsAg Positive ZZ, Z-null, null-null and S-null alpha 1 antitrypsin phenotypes and untypable Expected donor remnant less than 30% Prior living liver donor
CMS and OPTN: Independent Living Donor Advocate Require IDA and Informed Consent IDA required by both with similar elements Independence from candidate team No recipient involvement Training requirements: Living donation Transplant Ethics and informed consent Follow-up rules (OPTN) Grievance Process CMS: INFORMED CONSENT CMS Informed consent definition: A decision-making by the donor through a process in which: a) donor has been provided information about the decision and procedures, alternatives, risks, relevant uncertainties, benefits and other pertinent information; b) in a manner suitable for comprehension; c) includes an assessment by the informing practitioner that the person understands and can articulate this understanding; d) is voluntary Must be thoroughly documented in policy and patient record DOES NOT NEED TO BE A SIGNED DOCUMENT
CMS: INFORMED CONSENT CMS Informed consent required elements MOORE PEOPLE Medicare: 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 Outcomes: SRTR (and LD outcomes if available) Opt out at any time Risks: Medical, surgical and psychological/emotional Everything is confidentiality CMS: INFORMED CONSENT Required elements: MOORE PEOPLE Process: Donor evaluation, donation surgery, and post-donation recovery; potential complications; and general recovery from the surgery Emotional/psychological aspects of living donation Options for the recipient other than an organ donation from a living donor Pressures to donate (family or external) that impact the prospective living donor s decision about whether to donate Long-term clinical implications of the organ donation and how donor s medical history influences Economic: financial aspects of living donation including risk of future insurability and costs of future health problems that might not be covered
UNOS/OPTN: INFORMED CONSENT: Obtain, Provide, Disclose Transplant teams must: OBTAIN from living donors: The donor s signature on a document that confirms that the donor: Is willing to donate Is free from inducement and coercion and Has been informed that he or she may decline to donate at any time UNOS/OPTN: INFORMED CONSENT: Obtain, Provide, Disclose PROVIDE to living donors: Transplant teams must: An opportunity to discontinue the process in a way that is protected and confidential. The IDA must be available to assist the donor during the consent process Instruction re: all phases of the living donation process including: Consent Medical and psychosocial evaluations Pre and post operative care Required post-operative follow up Teaching must provided in donor s language and be interactive
UNOS/OPTN: INFORMED CONSENT Transplant teams must: DISCLOSE to the living donors: - I COVER FOR U ILDA must be provided Confidentiality & Criteria: Other procedures or courses of treatment for the recipient Valuable consideration Evaluation and Evaluation Risks Reporting requirements Follow up requirements Outcomes Risks of donation UNOS requires reporting of donor infectious disease and cancer UNOS/OPTN: INFORMED CONSENT Transplant teams must: DISCLOSE to the living donors: - I COVER FOR U ILDA must be provided Confidentiality & Criteria: Recovery hospital will take all reasonable precautions to maintain confidentiality for the donor and recipient. Recovery hospital has criteria for candidates, another hospital could have different criteria Other procedures or courses of treatment for the recipient, including deceased donor transplantation, and that: A deceased donor organ may become available for the candidate before the recovery hospital completes the living donor s evaluation or the living donor transplant occurs. Any transplant candidate may have risk factors for increased morbidity or mortality that are not disclosed to the donor. Valuable consideration
UNOS/OPTN: INFORMED CONSENT DISCLOSE to the living donors: - I COVER FOR U Evaluation and Evaluation Risks including: Medical and psychosocial evaluation is required Risks associated with evaluation: Allergic reactions to contrast Discovery of reportable infections Discovery of serious medical conditions Discovery of adverse genetic findings unknown to the donor Discovery of certain abnormalities that will require more testing at the donor s expense or create the need for unexpected decisions on the part of the transplant team Reporting: Health information obtained during the evaluation is subject to the same regulations as all medical records and could reveal conditions that must be reported to local, state, or federal public health authorities UNOS/OPTN: INFORMED CONSENT DISCLOSE to the living donors: - I COVER FOR U Follow-up requirements Hospital is required to report follow up data to UNOS Donor must commit to follow up Outcomes SRTR graft and patient survival for LD Recipient nationally and recipient hospital Medicare requirements not met by recipient hospital
UNOS/OPTN: INFORMED CONSENT DISCLOSE to the living donors: - I COVER FOR U Risks of Donation: Potential medical or surgical risks Death Scars, hernia, wound infection, blood clots, pneumonia, nerve injury, pain, fatigue, and other consequences typical any surgical procedure Abdominal symptoms such as bloating, nausea, and bowel obstruction That the mortality and morbidity of the donor may be impacted by obesity, HTN or other donor pre-existing conditions Potential psychosocial risks Body image Post surgery depression or anxiety But NOT Rejection?? Feelings of emotional distress or grief if the recipient experiences recurrent disease or dies UNOS/OPTN: INFORMED CONSENT DISCLOSE to the living donors: - I COVER FOR U Risks of Donation: Potential financial impacts: Need for life-long follow up at the donor s expense Loss of employment or income Negative impact on the ability to obtain future employment Negative impact on the ability to obtain, maintain, or afford health insurance, disability insurance, and life insurance Future health problems experienced by living donors following donation may not be covered by the recipient s insurance UNOS reporting of infectious disease or malignancy discovered in donor in first two years May also need to be reported to local, state, federal health agency Will be disclosed to recipient s center UNOS Patient Safety Portal
UNOS/OPTN: INFORMED CONSENT Transplant teams must: Disclose to the living donors: Organ-specific risk elements Kidneys: On average, living donors may have a 25-35% permanent loss of kidney function after donation. Baseline risk of ESRD for living kidney donors does not exceed that of the general population with the same demographic profile. Living donor risks must be interpreted in light of the known epidemiology of both CKD (develops in mid-life) and ESRD (after age 60). Medical evaluation of a younger donor cannot predict lifetime risk Living donors may be at higher risk if they damage the remaining kidney. Progression may be faster w/one kidney UNOS/OPTN: INFORMED CONSENT Organ-specific risk elements Kidneys: Dialysis is required if the donor develops ESRD. Current practice is to prioritize prior living kidney donors who become kidney transplant candidates Surgical risks may be transient or permanent and include but are not limited to: Potential medical or surgical risks Decreased kidney function Kidney failure and the need for dialysis or kidney transplant for the donor
UNOS/OPTN: INFORMED CONSENT Organ-specific risk elements Livers: Surgical risks may be transient or permanent and include but are not limited to: Acute liver failure with need for liver transplant. Transient liver dysfunction with recovery. The potential for transient liver dysfunction depends upon the amount of the total liver removed for donation. Risk of red cell transfusions or other blood products. Biliary complications, including leak or stricture that may require additional intervention. Post-donation laboratory tests may result in abnormal or false positive results that may trigger additional tests that have associated risks.???? Death (What am I missing here?) CMS Medicare Outcomes: SRTR (and LD outcomes if available) Opt out at any time Risks: Medical, surgical and psychological/emotional Everything is confidentiality Process: Emotional/psychological aspects of living donation Options for the recipient Pressures to donate Long-term clinical implications of the organ donation and how donor s medical history influences Economic CMS/OPTN Are They the Same? OPTN ILDA must be provided Confidentiality & Criteria: Other procedures or courses of treatment for the recipient Valuable consideration Evaluation and Evaluation Risks Reporting requirements Follow up requirements Outcomes Risks of donation UNOS requires reporting of donor infectious disease and cancer
CMS and OPTN: Processes ABO and other Vital Data Similar but not exactly the same Two ABOs required Must verify donor and recipient before donor surgery in OR OPTN requires donor/recipient to be awake Must verify AGAIN when organ comes into OR and before implantation/anatomsis Bar codes PLEASE!!! UNOS/OPTN: Packaging and Labeling, etc Vessels If you plan to use them must consent patient Can ONLY be used for transplant Can ONLY be used for intended recipient Storage rules the same as for deceased donors Packaging: If leaving recovery hospital MUST package and label similar to DD including using OPTN label
CMS: Patient Management Must have protocols for all phases of care Must be multidisciplinary in all phases of care: Physician Transplant Coordinator Social Work Nutrition Pharmacy Not prescriptive beyond this OPTN/UNOS does not have similar has team members listed only Scientific Registry for Transplant Recipients (SRTR) Recently moved from Ann Arbor to Minneapolis Analyzes data that UNOS collects Establishes risk adjustment and expected outcomes Releases data cohorts every six months 1 month, 1 year, 3 year outcomes (patient & graft survival) UNOS and CMS use 1 year data to evaluation transplant centers performance No living donor data reported although reporting on living donor outcomes is mandatory!
CMS COP Overview: Outcomes Standard: Outcomes*: One year patient and graft (transplant) non-compliance thresholds: Observed expected > 3 Observed/expected ratio = 1.5 1.85 = Standard > 1.85 in 2 of 5 = Condition level Observed vs. Expected one-sided p value <.05 On-site unannounced survey follows the meeting of threshold requirements OR You can receive an off-site citation for outcomes Report with volume and UNOS reporting sent to surveyors transplant program quarterly report (TPQR) No living donor outcomes UNOS/OPTN Overview: Outcomes Bayesian method will be flagged by MPSC for: 75% chance that hazard ratio of patient or graft survival is >1.2 (20%) worse than national experience 10% chance that HR of patient or graft survival is 2.5% (150%) No living donor outcomes * No outcomes for heart, lung, intestine, and pancreas OR Living Donors
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