Download All Appendices

Abbreviations

A1c glycosylated (hemoglobin) CPT current procedure and terminology AAPCC Adjusted average per capita cost CrCl creatinine clearance rate ACE-I angiotensin converting enzyme inhibitor CROWNWeb Consolidated Renal Operations in a Web-based Network (CROWN) Data — ACEI angiotensin-converting enzyme inhibitor data collection system for ESRD dialysis ACR albumin/creatinine ratio facilities mandated by CMS ADL activities of daily living CRT cardiac resynchronization ADR annual data report CVA cerebrovascular accident AF atrial fibrillation CVD cardiovascular disease AFIB atrial fibrillation CVVHD continuous venous-to-venous hemodialysis AFS Annual Facility Survey (CMS 2744) CWF common working file AJKD American Journal of Kidney Disease DCD donation after circulatory death AKI acute kidney injury DCI Dialysis Clinic Inc. AKI-D acute kidney injury with dialysis DFC dialysis facility compare AMI acute myocardial infarction DGF delayed graft function ANZDATA Australia & New Zealand ESRD database DHD daily hemodialysis ARB angiotensin receptor blocker DM diabetes mellitus AV arteriovenous DME durable medical equipment BMI body mass index DMMS Dialysis Morbidity and Mortality Study BUN blood urea nitrogen DPO darbepoetin alfa DRG diagnosis related group CABG coronary artery bypass grafting DSA Donation Service Area [or Disability CAD coronary artery disease Services Agency] CAPD continuous ambulatory peritoneal dialysis DUA data use agreement CBC complete blood count ECD expanded criteria donor CCPD continuous cycler peritoneal dialysis EDB Enrollment Database CDC Centers for Disease Control and Prevention eGFR estimated glomerular filtration rate CDM Clinformatics DataMart EGHP employer group health plan CDS Comprehensive Dialysis Study EPO erythropoietin CES-D Center for Epidemiologic Studies ESA erythropoiesis stimulating agent Depression Scale ESRD end-stage renal disease CKD chronic kidney disease FSD first service date CKD-EPI chronic kidney disease epidemiology GFR glomerular filtration rate calculation GLIMMIX SAS procedure CKO cytokinin oxidase GN glomerulonephritis CMS Centers for Medicare & Medicaid Services HbA1c glycosylated hemoglobin CMV cytomegalovirus (antibody status) HB hospital-based (providers) COPD chronic obstructive pulmonary disease HCFA Health Care Financing Administration CORR Canadian Organ Replacement Register (CMS before July 2001) CPM clinical performance measures HCPCS healthcare common procedure coding system CPRA calculated panel reactive bodies HD hemodialysis

2017 USRDS Annual Data Report | Appendices 643 Abbreviations

HDL high density lipoprotein NHANES National Health and Nutrition HEDIS Health Plan Employer Data Information NHIS National Health Interview Survey Set NIDDK National Institute of Diabetes and Hgb hemoglobin Digestive and Kidney Diseases HF heart failure NKF National Kidney Foundation HHA home health agency OMB Office of Management and Budget HIC health insurance claims OOP out-of-pocket HIC/BIC Health Insurance Claim/Beneficiary OP outpatient Identification Code OPTN Organ Procurement and Transplantation HIPAA Health Insurance Portability and Network Accountability Act PACE programs of all-inclusive care for the HLA Human Leukocyte antigen elderly HRSA Health Resources and Services PAD peripheral arterial disease Administration PCI percutaneous coronary interventions HS hospice PD peritoneal dialysis HSA Health Service Area PDE prescription drug event HTN hypertension PDP prescription drug plan ICD-9 International Classification of Diseases, 9th revision PII patient identifiable information ICD-9-CM International Classification of Diseases, PMMIS Program Medical Management and 9th revision, Clinical Modification Information System ICD implantable cardioverter defibrillators PPPM per person per month ICD/CRT-D implantable cardioverter defibrillators/ PPPY per person per year cardiac resynchronization therapy with PPS prospective payment system defibrillator devices PRA panel reactive antibodies ICW intracellular water pts patients IHD intermittent hemodialysis PTLD post-transplant lymphoproliferative IL2-RA interleukin 2 receptor alpha disorder IP inpatient PVD peripheral vascular disease IPD intermittent peritoneal dialysis QI qualifying individuals IRB Institutional Review Board QMB qualified Medicare beneficiaries ISHD ischemic heart disease RBC red blood cells IV intravenous REBUS Renal Beneficiary and Utilization System KDIGO Kidney Disease Improving Global REMIS Renal Management Information System Outcomes rhGH recombinant DNA human growth KDOQI Kidney Disease Outcomes Quality hormone Initiative RRB Railroad Retirement Board LDL low density lipoprotein SAF standard analysis file LDO large dialysis organization SAS Statistical Analysis System LIS low income subsidy SCA/VA Sudden cardiac arrest and ventricular MCBS Medicare Current Beneficiary Survey arrhythmias MDRD Modification of Diet in Renal Disease SCD sudden cardiac death MI myocardial infarction SCD standard criteria donor MPP Medicare as primary payer SDO small dialysis organizations MSP Medicare as secondary payer SHR standardized hospitalization ratio mTOR mammalian (or mechanistic) target of SMR standardized mortality ratio rapamycin SNF skilled nursing facility NCHS National Center for Health Statistics SSA Social Security Administration NCQA National Committee for Quality Assurance SSI Supplemental Security Income NEJM New England Journal of Medicine

644 2017 USRDS Annual Data Report | Appendices

SSRI selective serotonin reuptake inhibitor ST-segment EKG segment that follows the QRS complex and merges into the T wave STR standardized transplantation rate STrR standardized transfusion ratio TBW total body weight THMS Truven Health Market Scan TIA transient ischemic attack TrOOP true out-of-pocket costs Tx transplant TZD thiazolidinedione UNOS United Network for Organ Sharing URR urea reduction ratio USRDS United States Renal Data System VA vascular access VAT vascular access type WHO World Health Organization

645 Glossary

Acute kidney injury (AKI) Also known as acute Beta blockers Antihypertensive medications that kidney failure or acute renal failure is a sudden block B-adrenergic receptors, thus interfering decline in renal function triggered by any of a with the actions of endogenous catecholamines number of conditions such as shock, trauma, drug (epinephrine and norepinephrine), slowing the toxicity, acute glomerulonephritis, vasculitis, or heart rate and reducing the constriction of blood obstruction to urine flow. vessels.

Acute myocardial infarction (AMI) An event Blood urea nitrogen (BUN) A by-product of the causing death to a portion of the heart muscle due breakdown of amino acids and endogenous and to lack of blood supply. ingested protein.

Adult polycystic kidney disease An inherited Body mass index (BMI) A measure of height to disease in which normal kidney tissue is replaced weight ratio: weight (kg)/height (m2). by multiple cysts. C-reactive protein A protein produced by the liver Albumin/creatinine ratio (ACR) A screening test in response to infection or inflammation; high used to estimate the amount of albumin in a levels are associated with an increased risk of heart patients urine. disease and stroke.

Anemia A condition marked by a reduced number of Calcium channel blockers Antihypertensive agents red cells in the bloodstream. that work by blocking the access of calcium to muscle cells in artery walls. Angiography A radiographic procedure where a radio- opaque contrast material is injected into a blood Cardiac arrest A sudden complete cessation of vessel for the purpose of identifying its anatomy. cardiac activity.

Angioplasty A procedure in which a balloon catheter is Cardiac resynchronization therapy defibrillator inserted into a blocked or narrowed vessel in order (CRT-D) An implantable device designed to arrest to reopen the vessel and allow normal blood flow. the fibrillation of heart muscle by applying an electric shock , thus depolarizing the heart cells Angiotensin converting enzyme (ACE) inhibitor and allowing normal rhythm to return. An antihypertensive agent that inhibits the conversion of Angiotensin I to angiotensin II. Can Cardiomyopathy A general diagnostic term delay progression of kidney disease in diabetics. indicating a disease of the heart muscle.

Angiotensin II receptor blocker (ARB) An Catastrophic coverage Health insurance to cover antihypertensive agent that inhibits the actions costs that exceed routine healthcare insurance of angiotensin II, a substance which causes benefits. constriction of blood vessels. Coronary Artery Disease (CAD) A disease of the Arteriovenous fistula A type of vascular access arteries of the heart, characterized by a used in hemodialysis patients, and created by the thickening and narrowing and/or loss of elasticity anastomosis of an artery and a vein. of the arterial walls due to plaque deposition.

Arteriovenous graft A type of vascular access used in Dialysis catheter A vascular access used in hemodialysis patients and created via a connection hemodialysis patients, commonly implanted into between an artery and vein using either a native the jugular or subclavian vein. vessel (e.g. saphenous vein) or a synthetic material.

2017 USRDS Annual Data Report | Appendices 646 Glossary Centers for Disease Control & Prevention (CDC) Under the CWF, CMS maintains both institutional The lead federal agency for protecting the health and physician supplier claims-level data. CWF and safety of people at home and abroad; develops claims records are the data source for most claims and applies programs designed to improve the and utilization files used by the USRDS. health of the people of the United States. Comprehensive Dialysis Study (CDS) A special data Centers for Medicare and Medicaid Services collection study that focuses on physical activity (CMS) Formerly the Health Care Financing level, health-related quality of life, and work/ Administration (HCFA). Federal agency that disability status reported by patients who have administers the Medicare, Medicaid, and State recently started maintenance dialysis. Childrens’ Health insurance programs. Continuous ambulatory peritoneal dialysis Cerebrovascular accident (CVA) A general (CAPD) A type of dialysis in which dialysate is descriptor that encompasses such problems as continuously present in the abdominal cavity. stroke and cerebral hemorrhage. Fluid is exchanged using gravity to fill and empty the cavity 4–5 times a day. Cerebrovascular disease A disease that causes narrowing or occlusion of the arteries supplying Continuous cycler-assisted peritoneal dialysis blood to the brain. (CCPD) A type of dialysis in which the abdominal cavity is filled and emptied of dialysate using an Chain provider A single business entity that at years automated cycler machine. end owns or operates 20 or more freestanding dialysis units. This definition applies to all chain Coverage gap The interval after initial benefits are affiliation references in the USRDS Annual Data exhausted, but preceding catastrophic coverage. Reports. An alternative definition from the Centers for Medicare and Medicaid Services can be found Creatinine A waste product of protein metabolism under “definitions” in the Health Care Provider/ found in the urine. Blood creatinine concentration Supplier Application Form, CMS 855. is an indirect measure of kidney function. Abnormally high creatinine levels indicate kidney Chronic kidney disease (CKD) A condition in which failure or renal insufficiency. there is a progressive loss of kidney function which over time may lead to end-stage renal disease. Creatinine clearance A measure of kidney function.

Chronic Kidney Disease Epidemiology Creditable coverage Prescription drug coverage Collaboration (CKD-EPI) A method used to that is actuarially equivalent to the standard estimate glomerular filtration rate using a single Part D benefit, as defined annually by CMS. serum creatinine. Yields a lower CKD prevalence Beneficiaries with creditable coverage may forgo than the Modification of Diet in Renal Disease participation in Medicare Part D without having (MDRD) Study equation. to pay increased monthly premiums upon future enrollment. Examples of creditable coverage Chronic obstructive pulmonary disease (COPD) include the Federal Employee Health Benefits One of a number of classes of chronic progressive Program, TRICARE, VA Health Care Benefits, lung diseases . State Pharmacy Assistance Programs (SPAPs), and private insurance that is eligible for the retiree Clinical Performance Measures (CPM) Project drug subsidy. Private insurance for the working Formerly the Core Indicator Project. A project in aged may or may not be creditable. which CMS and the ESRD networks cooperatively maintain a clinical database of key elements Cystatin-C equation A method which uses the related to the quality of dialysis care. These laboratory marker cystatin-C for estimating elements are used as indicators in quality glomerular filtration rate (GFR). improvement initiatives.

Common Working File (CWF) System The Medicare Heart failure (HF) A condition caused by impaired inpatient/outpatient and physician/supplier pumping of the heart and consequent fluid benefit coordination and claims validation system. accumulation in the lungs. 647 2017 USRDS Annual Data Report | Appendices Darbepoetin alfa (DPO) One of a class of medications Fills per person Each prescription drug purchase called erythropoietic proteins. Used to treat anemia constitutes a fill. Fills per person are calculated in patient with serious kidney disease. from the quotient of cumulative fills in a population and the number of people in that Death Notification Form (CMS-2746) A form population. submitted following the death of an ESRD patient, and containing basic patient demographic Glomerular filtration rate (eGFR) Rate in ml/ information in addition to information on the min/1.73 m2 of the volume of plasma filtered by primary cause of death. the kidney. Rates of filtration may be measured directly or estimated based on formulae that Employer group health plan (EGHP) A health plan employ combinations of an individual’s age, of or contributed to by an employer, providing gender, and height, and on levels of serum medical care directly or through other methods creatinine, blood urea nitrogen, and serum such as insurance or reimbursement to current or albumin. GFR is traditionally considered the best former employees, or to these employees and their overall index to determine renal function. families. Glycosylated hemoglobin (HbA1c) test Used to End-stage renal disease (ESRD) A condition in help determine how well a patient’s diabetes is which a person’s kidney function is inadequate to being controlled, this test measures the percentage support life. of hemoglobin-bound glucose in the bloodstream.

Erythropoiesis stimulating agent (ESA) Used to Health Maintenance Organization (HMO) An increase the production of red blood cells; includes organization that provides or arranges managed erythropoietin (EPO) and darbepoetin alfa (DPO). care on a prepaid basis.

Erythropoietin (EPO) A hormone secreted chiefly by Health Service Area (HSA) A group of counties the adult kidney; acts on bone marrow to stimulate described by the authors of the CDC Atlas of red cell production. Also produced in a formulated United States Mortality as “an area that is relatively version to treat anemia. self-contained with respect to hospital care.”

ESRD Facility Survey Data for this survey are Healthy People 2020 A national agenda for collected annually by CMS from all facilities health promotion and disease prevention, with certified to provide Medicare-covered renal objectives and goals aimed at improving the dialysis and transplantation. The survey uses CMS health of the American people (www.health.gov/ form 2744, and encompasses the full calendar year. healthypeople). Geographic data are included to the level of facility ZIP code. Each record contains facility information Hemodialysis The process of removing toxins from and data on the number of patients served, dialysis the blood by diffusion through a semi-permeable treatments provided, and kidney transplants membrane. performed. The data include services to both Medicare and non-Medicare patients. Hemoglobin Oxygen-carrying protein in the erythrocyte (red blood cell). ESRD Networks Regional organizations, established by law in 1978, contracted by CMS to perform Hepatitis An inflammation of the liver that may be quality oversight activities to assure the caused by a viral infection, poisons, or the use of appropriateness of services and protection for alcohol or other drugs. Forms include Hepatitis dialysis patients. A, usually transmitted by contaminated food or water; Hepatitis B transmitted through blood Expanded criteria donors (ECDs) Any kidney donor and body fluids; and Hepatitis C, also transmitted over the age of age 60 years, or donors between the through blood and body fluids. ages of 50 and 59 years with two of the following criteria: death by CVA, history or hypertension or Hospital-based facility A dialysis unit attached to creatinine at time of recovery (terminal creatinine) or located in a hospital and licensed to provide ≥ 1.5 mg/dL. outpatient dialysis services directly to ESRD patients. 648 Glossary Implantable cardioverter defibrillator (ICD) Medical Evidence form (CMS-2728) A form which An implantable device designed to arrest the provides source data about ESRD patients, fibrillation of (heart muscle) by applying electric including information on demographics, primary shock thus depolarizing the heart cells and cause of renal disease, comorbidity, biochemical allowing normal rhythm to return. data, dialysis treatment, transplant, dialysis training, employment status, initial insurance Incident ESRD patient A patient starting renal coverage, and first ESRD service date. replacement therapy for ESRD. Excludes patients with acute renal failure, those with chronic renal Medicare Advantage Part D plans (MA-PDs) failure who die before starting ESRD treatment, and Medicare Part D plans that are offered only to those whose treatments are not reported to CMS. participants in Medicare Part C.

Incident population The people in a population who Medicare as Secondary Payer (MSP) patient A are newly diagnosed with a disease in a given time Medicare beneficiary with a health insurer other period, typically a year. than Medicare (e.g. an Employer Group Health Plan) that has primary responsibility for payment Independent unit A unit licensed to provide of the beneficiary’s medical bills. outpatient and home maintenance dialysis, and not affiliated with a chain. Medicare Current Beneficiary Survey (MCBS) An ongoing national survey of aged, disabled, and Initial coverage period The interval following the institutionalized Medicare beneficiaries sponsored deductible phase, but preceding the coverage gap. by the Centers for Medicare and Medicaid Services, Ischemic heart disease (ISHD) A disease of the and used to study the health status, health care use heart evidenced by a lowered oxygen supply to the and expenditures, health insurance coverage, and heart tissue, caused by occlusion or narrowing of socioeconomic and demographic characteristics of the arteries supplying the heart muscle. Medicare beneficiaries.

Kidney Disease Outcomes Quality Initiative Microalbuminuria A condition in which small (KDOQI) Established in 1995 by the National amounts of albumin are present in the urine; Kidney Foundation to improve patient outcomes indicates early kidney damage. and survival by providing recommendations for Modality A method of treatment. Treatment for end- optimal clinical practices in the areas of dialysis stage renal disease (ESRD) is comprised of three adequacy, vascular access, and anemia. modalities: hemodialysis, peritoneal dialysis, and Kt/V A unitless number used to quantify clearance transplantation. of small molecular weight substances (solutes) Modification of Diet in Renal Disease (MDRD) such as urea, where K = dialyzer clearance of urea, Study equation A method used to estimate t = dialysis time and V = volume of distribution glomerular filtration (GFR) in patients with of urea, (approximately equal to the total body impaired renal function using a single serum water). It reflects the degree of removal of these creatinine, age, sex and race. substances during dialysis treatment and is expressed by Kt/V per hemodialysis session or National Health and Nutrition Examination weekly Kt/V in the context of peritoneal dialysis. Survey (NHANES) A survey conducted by the National Center for Health Statistics (NCHS) at Low income subsidy (LIS) For Medicare beneficiaries the Centers for Disease Control and Prevention; with limited income and/or assets, the costs of using home interviews and health tests to collect participation in Medicare Part D may be reduced information on health and diet in the United States. by the LIS. Beneficiaries who are dually eligible for Medicare and Medicaid are automatically granted National Institutes of Health (NIH) The federal the LIS, while beneficiaries who are not dually focal point for medical research in the U.S. and eligible may apply for it. While the LIS may take one of eight health agencies of the Public Health eight different levels, with monthly premiums and Services, which are part of the Department of copayments either eliminated or reduced, all dually Health and Human Services. eligible beneficiaries pay no monthly premiums. 649 Organ Procurement and Transplantation before receiving treatment for ESRD, and those Network (OPTN) The unified transplant network whose ESRD treatments are not reported to CMS. established by the United States Congress under the National Organ Transplant Act (NOTA) Prevalent population The people in a population of 1984. A private, non-profit organization who have a disease at a given point in time (point administered by the United Network for prevalence) or during a given time period (period Organ Sharing, under contract with the Health prevalence). Resources and Services Administration of the U.S. Proteinuria The existence of protein in the urine; Department of Health and Human Services. indicative of kidney damage.

Part D Medicare coverage A U.S. government Recombinant human growth hormone (rhGH) program which subsidizes the costs of medications Also called somatropin; a substance identical in its for Medicare beneficiaries. amino acid sequence to human growth hormone, Percutaneous coronary intervention (PCI) A and used to treat growth hormone deficiency. therapeutic procedure to treat stenotic (narrowed) REMIS CMS’s Renal Management Information System coronary arteries of the heart found in coronary (REMIS), which has replaced the Renal Beneficiary heart disease. Commonly known as coronary and Utilization System (REBUS). It included angioplasty or simply angioplasty. an operational interface to the SIMS Central Period prevalent patient A patient receiving Repository until 2012 at which point CROWNWeb treatment for ESRD at some point during a period replaced the functionality of SIMS. of time, usually six months or a year. Patients may Renin Inhibitors A class of drugs used to lower die during the period or be point prevalent at the blood pressure by blocking the renin-angiotensin end of the period. Period prevalence is a useful system which regulates blood volume and systemic measure for cost analysis, since it indicates total vascular resistance. disease burden over the course of a year. Retiree drug subsidy (RDS) A program designed Peripheral vascular disease (PVD) A progressive to encourage employers to continue to provide disease that causes narrowing or occlusion of the prescription drug coverage to retirees eligible for arteries. Medicare Part D. Under the program, employers Peritoneal dialysis Dialysis in which fluid (dialysate) received a tax-free rebate equal to 28 percent is introduced into the abdominal cavity and of covered prescription drug costs incurred by uremic toxins are removed by diffusion across the its retirees. The program is relatively simple to peritoneum. administer, but may ultimately be more costly than providing employees a type of Part D plan known Point prevalent patient A patient reported as as an “employer group waiver plan.” Following receiving treatment for ESRD on a particular day of passage of the Patient Protection and Affordable the calendar year (e.g. December 31). Care Act, the tax-free status of the subsidy expired on December 31, 2012. Program Medical Management and Information System for ESRD, and Renal Beneficiary and SIMS CMS’s Standard Information Management Utilization System (PMMIS/REBUS) The System (SIMS), which became operational at major source of data for the USRDS. This CMS file the beginning of 2000 and was replaced by incorporates data from the Medical Evidence form CROWNWeb in 2012. Supports CMS reporting (CMS 2728), the Death Notification form (CMS requirements and the business processes of the 2746), the Medicare Enrollment Database, CMS paid ESRD networks; provides communication and data claims records, and the OPTN transplant database. exchange links for the networks, CMS, and other parts of the renal community; supplies standard Prevalent ESRD patient A patient on renal core data functionality for previous network replacement therapy or with a functioning kidney data systems; and provides improved electronic transplant (regardless of the transplant date). communication capabilities, data standardization, This definition excludes patients with acute renal and information management tools. failure, those with chronic renal failure who die 650 Glossary Standard Analysis Files (SAFs) CMS files containing Vintage Time that a patient has had ESRD. final action Medicare inpatient/outpatient claims data: Inpatient, Outpatient, Home Health Waiting list A list of patients awaiting an organ Agency, Hospice, Skilled Nursing Facility, Clinical transplant; maintained by the Organ Procurement Laboratory, Durable Medical Equipment, and 5 and Transplantation Network (OPTN). percent Sample Beneficiary. Some definitions from U.S. National Library of Standardized hospitalization ratio (SHR) Used to Medicine’s Medical Dictionary: http://www.nlm.nih. gov/medlineplus/mplusdictionary.html compare hospitalization rates for a selected group of patients by computing the ratio of the group’s observed hospitalization rate to the expected hospitalization rate for the national ESRD population.

Standardized mortality ratio (SMR) Used to compare patient mortality rates for a selected group of patients by computing the ratio of the group’s observed mortality rate to the expected mortality rate for the national ESRD population.

Standardized transplantation ratio (STR) Used to compare transplant rates for a subgroup of patients to national transplant rates, by computing the ratio of the group’s observed transplant rate to the expected transplant rate for the national ESRD population.

Statins Medications that lower cholesterol through inhibition of the HMG CoA enzyme.

Total days supply Each prescription drug is disbursed with sufficient quantity to administer for a set number of days, so long as instructions are followed. The total days supplied is equal to the cumulative number of days supplied through all fills of a particular medication in a population.

Transient ischemic attacks (TIA) A temporary loss of neurological function caused by a brief period of inadequate blood supply in a portion of the brain.

United Network for Organ Sharing (UNOS) A private, non-profit organization that holds the Organ Procurement and Transplantation Network contract to maintain the national organ transplant waiting lists and coordinates the matching and distribution of organs to patients awaiting transplant.

Urea reduction ratio (URR) A means of measuring dialysis efficiency by calculating the change in blood urea nitrogen (BUN) over the course of a dialysis treatment. URR = (pre-dialysis – post- dialysis BUN) / pre-dialysis BUN * 100.

651 United States Renal Data System (USRDS) Agreement for Release of Data

Project Title ______

In this agreement, “Requester Organization” means ______

 the identification and targeting of under- or over-served health service markets primarily for commercial benefit  the obtaining of information about providers or facilities for commercial benefit  insurance purposes such as redlining areas deemed to offer bad health insurance risks  adverse selection (e.g., identifying patients with high risk diagnoses). Any use of the Data for research not in the original proposal must be approved by the USRDS Project Officer (PO).

F. The Requester shall not publish or otherwise disclose the Data in the files to any person or organization unless the Data have been aggregated (that is, combined into groupings of Data such that the Data are no longer specific to any individuals within each grouping), and no cells (aggregates of Data) contain information on fewer than ten individuals or fewer than five providers or facilities. The Requester shall not publish or otherwise disclose Data that identify individual providers or facilities, or from which such identities could be inferred. However, the

652 Requester may release Data to a contractor for purposes of data processing or storage if (1) the Requester specified in the research plan submitted to the USRDS Project Officer that Data would be released to the particular contractor, or the Requester has obtained written authorization from the PO to release the Data to such contractor, and (2) the contractor has signed a data release agreement with the PO. G. A copy of any aggregation of Data intended for publication shall be submitted to the PO for review for compliance with the confidentiality provisions of this agreement prior to submission for publication and, if not approved, shall not be published until compliance is achieved. The PO must respond within 30 days. The Approval Request Checklist may be found at: https://www.usrds.org/2017/appx/3_1_USRDS_Manuscript_Approval_Request_Checklist_17.pdf H. Appropriate administrative, technical, procedural, and physical safeguards shall be established by the Requester to protect the confidentiality of the Data and to prevent unauthorized access to it. The safeguards shall provide a level of security outlined in OMB Circular No. A-130, Appendix III — Security of Federal Automated Information Resources, which sets forth guidelines for security plans for automated information systems in Federal agencies. I. No copies or derivatives shall be made of the Data in these files except as necessary for the purpose authorized in this agreement. The Requester shall keep an accurate written account of all such copies and derivative files, which will be furnished upon request to the PO. The USRDS Data files covered in this data use agreement (DUA) may be retained by the Requester until the date specified by the PO in the approval letter, at which time Requester may request renewal of this data use agreement to extend the retention period to comply with legal or institutional recordkeeping requirements or to maintain the integrity of the research or research publications. If at any time during the data retention period the DUA between USRDS and CMS is canceled, the Requester will be contacted to destroy the files in their possession. At the completion of the activities in the research plan, the file(s) and any derivative files and copies shall be destroyed. At that time, the Requester will inform the USRDS and the PO in writing that the files have been destroyed. J. For the purpose of inspecting security procedures and arrangements, authorized representatives of the NIDDK and/or of CMS will, upon request, be granted access to premises where the Data are kept.

653 K. The following USRDS Data file(s) is/are covered under this Agreement.

Standard Analysis Files (SAFs) requested:

☐ Core ☐ Dialysis Morbidity and Mortality Study (DMMS)

☐ Transplant ☐ Comprehensive Dialysis Study (CDS)

☐ Hospital ☐ Clinical Performance Measures

☐ CKD 5% Cohort Core ☐ Case Mix Adequacy (CMA)

☐ CKD 5% Cohort Hospital ☐ Active-Adipose Study (AAS)

☐ CROWNWeb Clinical Data

For the following SAFs, indicate the claim year(s) requested as well:

☐ Institutional Claims (pre-1989 through 2015 available) ______

☐ Physician/Supplier Claims (1991–2015 available) ______

☐ Part D (2006–2015 available) ______

☐ Pre-ESRD Institutional Claims (incident years 1995-2015) ______

☐ Pre-ESRD Physician/Supplier Claims (incident years 1995-2015) ______

☐ Pre-ESRD Part D (incident years 2008-2015) ______

☐ CKD 5% Institutional Claims (1992–2015 available) ______

☐ CKD 5% Physician/Supplier Claims (1992–2015 available) ______

☐ CKD 5% Part D (2006–2015 available) ______

Other:

☐ Provider Crosswalk ☐ Physician Crosswalk

______Requester Signature (for the Institutional Official for Data Assurance)

______Authorized Signatory (name, title & date)

______Requester Address

______Requester Telephone Number

654 Read and Acknowledged (for Primary Investigator and all co-investigators who will analyze data directly)

______Investigator / Analyst signature Name Date

(attach additional signature pages as necessary)

USRDS Project Officer: Kevin C. Abbott, MD, NIDDK, NIH, [email protected]

USRDS Project Officer Signature Date

Checklist: DID YOU REMEMBER TO SEND: ☐ Signed copy of your institutional IRB approval memo ☐ Copy of your project proposal in recommended format at http://www.usrds.org/2017/appx/3/1_Outline_for_research_proposals_using_USRDS_data.pdf ☐ Copy of this Data Use Agreement signed by your institutional official, PI, and all active participants.

Please note that any MODIFICATIONS or AMMENDMENTS, regardless of whether they require additional files, require a new IRB approval memo (1 above), copy of the original project proposal (2 above) with additional analyses/extractions highlighted, and a new signed Data Use Agreement (3).

Please send ALL documents (including the research protocol) in PDF format (please save the research protocol as PDF within Microsoft Word when you have completed it). AND consolidate all files into a single PDF file (using the “PDF Portfolio” feature in Adobe) when sending to the NIDDK.

01/15/2018 revision

655 United States Renal Data System (USRDS) Merged Dataset Agreement for Release of Data

Project Title ______

In this agreement, “Requester Organization” means ______

A. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through the United States Renal Data System (USRDS) Coordinating Center, will provide the Requester data extracted from the USRDS research database (the “Data”), via download or on CDs, DVDs, or other media type. Prior to receiving USRDS data, the Requester will provide USRDS with a list of personally identifiable information (PII) so USRDS can report which of the Requester’s subjects are in the USRDS end-stage renal disease (ESRD) data. B. The sole purpose of providing the Data is the conduct of legitimate and approved biomedical, cost-effectiveness, and/or other economic research by the Requester. C. USRDS shall not use or disclose the Requester’s data for any purpose other than to create the Data extracted from the USRDS database. In the event that the Requester’s data is used or disclosed for any purpose other than that covered by this agreement, USRDS will notify the Requester immediately and agree to work with Requester to address the use or disclosure. The USRDS will destroy the Requester’s dataset one year after the linkage is complete unless otherwise specified by the Requester in the research proposal. D. The Requester shall not combine or link the Data provided with any other collection or source of information that may contain information specific to individuals on the files, except where a waiver of authorization has been approved by the Requester’s IRB/Privacy Board and NIDDK. E. The Requester shall not use the Data for purposes that are not related to biomedical research, cost-effectiveness, economic and/or other epidemiological research. Purposes for which the Data may not be used include, but are not limited to,  the identification and targeting of under- or over-served health service markets primarily for commercial benefit  the obtaining of information about providers or facilities for commercial benefit  insurance purposes such as redlining areas deemed to offer bad health insurance risks  adverse selection (e.g., identifying patients with high risk diagnoses) Any use of the Data for research not in the original proposal must be approved by the USRDS Project Officer (PO). F. The Requester shall not publish or otherwise disclose the Data in the files to any person or organization unless the Data have been aggregated (that is, combined into groupings of Data

656 such that the Data are no longer specific to any individuals within each grouping), and no cells (aggregates of Data) contain information on fewer than ten individuals or fewer than five providers or facilities. The Requester shall not publish or otherwise disclose Data that identify individual providers or facilities, or from which such identities could be inferred. However, the Requester may release Data to a contractor for purposes of data processing or storage if (1) the Requester specified in the research plan submitted to the USRDS Project Officer that Data would be released to the particular contractor, or the Requester has obtained written authorization from the PO to release the Data to such contractor, and (2) the contractor has signed a data release agreement with the PO. G. A copy of any aggregation of Data intended for publication shall be submitted to the PO for review for compliance with the confidentiality provisions of this agreement prior to submission for publication and, if not approved, shall not be published until compliance is achieved. The PO must respond within 30 days. The Approval Request Checklist may be found at: https://www.usrds.org/2017/appx/3_1_USRDS_Manuscript_Approval_Request_Checklist_17.pdf H. Appropriate administrative, technical, procedural, and physical safeguards shall be established by the Requester to protect the confidentiality of the Data and to prevent unauthorized access to it. The safeguards shall provide a level of security outlined in OMB Circular No. A-130, Appendix III — Security of Federal Automated Information Resources, which sets forth guidelines for security plans for automated information systems in Federal agencies. I. No copies or derivatives shall be made of the Data in these files except as necessary for the purpose authorized in this agreement. The Requester shall keep an accurate written account of all such copies and derivative files, which will be furnished upon request to the PO. The USRDS Data files covered in this data use agreement (DUA) may be retained by the Requester until the date specified by the PO in the approval letter, at which time Requester may request renewal of this data use agreement to extend the retention period to comply with legal or institutional recordkeeping requirements or to maintain the integrity of the research or research publications. If at any time during the data retention period the DUA between USRDS and CMS is canceled, the Requester will be contacted to destroy the files in their possession. At the completion of the activities in the research plan, the file(s) and any derivative files and copies shall be destroyed. At that time, the Requester will inform the USRDS and the PO in writing that the files have been destroyed. J. For the purpose of inspecting security procedures and arrangements, authorized representatives of the NIDDK and/or of CMS will, upon request, be granted access to premises where the Data are kept.

657 K. The following USRDS Data file(s) is/are covered under this Agreement. Standard Analysis Files (SAFs) requested: ☐ Core ☐ Dialysis Morbidity and Mortality Study (DMMS) ☐ Transplant ☐ Comprehensive Dialysis Study (CDS) ☐ Hospital ☐ Clinical Performance Measures ☐ CKD 5% Cohort Core ☐ Case Mix Adequacy (CMA) ☐ CKD 5% Cohort Hospital ☐ Active-Adipose Study (AAS) ☐ CROWNWeb Clinical Data

For the following SAFs, indicate the claim year(s) requested as well:

☐ Institutional Claims (pre-1989 through 2015 available) ______

☐ Physician/Supplier Claims (1991–2015 available) ______

☐ Part D (2006–2015 available) ______

☐ Pre-ESRD Institutional Claims (incident years 1995-2015) ______

☐ Pre-ESRD Physician/Supplier Claims (incident years 1995-2015) ______

☐ Pre-ESRD Part D (incident years 2008-2015) ______

☐ CKD 5% Institutional Claims (1992–2015 available) ______

☐ CKD 5% Physician/Supplier Claims (1992–2015 available) ______

☐ CKD 5% Part D (2006–2015available) ______Other: ☐ Provider Crosswalk ☐ Physician Crosswalk

IMPORTANT! Specify: ☐Data ONLY on matched patients OR ☐Complete SAFs, including matched and unmatched patients

______Requester Signature (for the Institutional Official for Data Assurance)

______Authorized Signatory (name, title & date)

______Requester Address ______Requester Telephone Number

658 Read and Acknowledged (for Primary Investigator and all co-investigators who will analyze data directly)

______Investigator / Analyst signature Name Date

(attach additional signature pages as necessary)

USRDS Project Officer: Kevin C. Abbott, MD, NIDDK, NIH, [email protected]

USRDS Project Officer Signature Date

Checklist: DID YOU REMEMBER TO SEND: ☐ Signed copy of your institutional IRB approval memo ☐ Copy of your project proposal in recommended format at http://www.usrds.org/2017/appx/3/2_Outline_for_research_proposals_using_merged_USRDS_data.pdf ☐ Copy of this Data Use Agreement signed by your institutional official, PI, and all active participants.

01/15/2018 revision

659 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0046 END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION A. COMPLETE FOR ALL ESRD PATIENTS Check one: Initial Re-entitlement Supplemental 1. Name (Last, First, Middle Initial)

2. Medicare Claim Number 3. Social Security Number 4. Date of Birth

MM DD YYYY 5. Patient Mailing Address (Include City, State and Zip) 6. Phone Number ( )

7. Sex 8. Ethnicity 9. Country/Area of Origin or Ancestry Male Female Not Hispanic or Latino Hispanic or Latino (Complete Item 9) 10. Race (Check all that apply) 11. Is patient applying for ESRD White Asian Medicare coverage? Black or African American Native Hawaiian or Other Pacific Islander* American Indian/Alaska Native Yes No Print Name of Enrolled/Principal Tribe ______*complete Item 9 12. Current Medical Coverage (Check all that apply) 13. Height 14. Dry Weight 15. Primary Cause of Renal (Use code from back of form) Medicaid Medicare Employer Group Health Insurance INCHES ______OR POUNDS ______OR Failure DVA Medicare Advantage Other None CENTIMETERS ______KILOGRAMS ______16. Employment Status (6 mos prior and 17. Co-Morbid Conditions (Check all that apply currently and/or during last 10 years) *See instructions current status) a. Congestive heart failure n. Malignant neoplasm, Cancer tnerruC roirP b. Atherosclerotic heart disease ASHD o. Toxic nephropathy c. Other cardiac disease p. Alcohol dependence Unemployed d. Cerebrovascular disease, CVA, TIA* q. Drug dependence* e. Peripheral vascular disease* r. Inability to ambulate Employed Full Time f. History of hypertension s. Inability to transfer Employed Part Time g. Amputation t. Needs assistance with daily activities Homemaker h. Diabetes, currently on insulin u. Institutionalized Retired due to Age/Preference i. Diabetes, on oral medications 1. Assisted Living j. Diabetes, without medications 2. Nursing Home Retired (Disability) k. Diabetic retinopathy 3. Other Institution Medical Leave of Absence l. Chronic obstructive pulmonary disease v. Non-renal congenital abnormality Student m. Tobacco use (current smoker) w. None 18. Prior to ESRD therapy: a. Did patient receive exogenous erythropoetin or equivalent? Yes No Unknown If Yes, answer: 6-12 months >12 months b. Was patient under care of a nephrologist? Yes No Unknown If Yes, answer: 6-12 months >12 months c. Was patient under care of kidney dietitian? Yes No Unknown If Yes, answer: 6-12 months >12 months d. What access was used on first outpatient dialysis: AVF Graft Catheter Other If not AVF, then: Is maturing AVF present? Yes No Is maturing graft present? Yes No 19. Laboratory Values Within 45 Days Prior to the Most Recent ESRD Episode. (Lipid Profile within 1 Year of Most Recent ESRD Episode). LABORATORY TEST VALUE DATE LABORATORY TEST VALUE DATE a.1. Serum Albumin (g/dl) ___ . ___ d. HbA1c ______. ___% a.2. Serum Albumin Lower Limit ___ . ___ e. Lipid Profile TC ______a.3. Lab Method Used (BCG or BCP) LDL ______b. Serum Creatinine (mg/dl) ______. ___ HDL ______c. Hemoglobin (g/dl) ______. ___ TG ______B. COMPLETE FOR ALL ESRD PATIENTS IN DIALYSIS TREATMENT 20. Name of Dialysis Facility 21. Medicare Provider Number (for item 20)

22. Primary Dialysis Setting 23. Primary Type of Dialysis Home Dialysis Facility/Center SNF/Long Term Care Facility Hemodialysis (Sessions per week____/hours per session____) CAPD CCPD Other 24. Date Regular Chronic Dialysis Began 25. Date Patient Started Chronic MM DD YYYY Dialysis at Current Facility MM DD YYYY 26. Has patient been informed of kidney transplant options? 27. If patient NOT informed of transplant options, please check all that apply: Yes No Medically unfit Patient declines information Unsuitable due to age Patient has not been assessed Psychologically unfit Other 660FORM CMS-2728-U3 (06/04) EF(03/2005) C. COMPLETE FOR ALL KIDNEY TRANSPLANT PATIENTS 28. Date of Transplant 29. Name of Transplant Hospital 30. Medicare Provider Number for Item 29

MM DD YYYY Date patient was admitted as an inpatient to a hospital in preparation for, or anticipation of, a kidney transplant prior to the date of actual transplantation. 31. Enter Date 32. Name of Preparation Hospital 33. Medicare Provider number for Item 32

MM DD YYYY 34. Current Status of Transplant (if functioning, skip items 36 and 37) 35. Type of Donor: Functioning Non-Functioning Deceased Living Related Living Unrelated 36. If Non-Functioning, Date of Return to Regular Dialysis 37. Current Dialysis Treatment Site Home Dialysis Facility/Center SNF/Long Term Care Facility MM DD YYYY D. COMPLETE FOR ALL ESRD SELF-DIALYSIS TRAINING PATIENTS (MEDICARE APPLICANTS ONLY) 38. Name of Training Provider 39. Medicare Provider Number of Training Provider (for Item 38)

40. Date Training Began 41. Type of Training Hemodialysis a. Home b. In Center

MM DD YYYY CAPD CCPD Other 42. This Patient is Expected to Complete (or has completed) Training 43. Date When Patient Completed, or is Expected to Complete, Training and will Self-dialyze on a Regular Basis.

Yes No MM DD YYYY I certify that the above self-dialysis training information is correct and is based on consideration of all pertinent medical, psychological, and sociological factors as reflected in records kept by this training facility. 44. Printed Name and Signature of Physician personally familiar with the patient’s training 45. UPIN of Physician in Item 44

a.) Printed Name b.) Signature c.) Date MM DD YYYY E. PHYSICIAN IDENTIFICATION 46. Attending Physician (Print) 47. Physician’s Phone No. 48. UPIN of Physician in Item 46 ( ) PHYSICIAN ATTESTATION I certify, under penalty of perjury, that the information on this form is correct to the best of my knowledge and belief. Based on diagnostic tests and laboratory findings, I further certify that this patient has reached the stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplant to maintain life. I understand that this information is intended for use in establishing the patient’s entitlement to Medicare benefits and that any falsification, misrepresentation, or concealment of essential information may subject me to fine, imprisonment, civil penalty, or other civil sanctions under applicable Federal laws. 49. Attending Physician’s Signature of Attestation (Same as Item 46) 50. Date

MM DD YYYY 51. Physician Recertification Signature 52. Date

MM DD YYYY 53. Remarks

F. OBTAIN SIGNATURE FROM PATIENT

I hereby authorize any physician, hospital, agency, or other organization to disclose any medical records or other information about my medical condition to the Department of Health and Human Services for purposes of reviewing my application for Medicare entitlement under the Social Security Act and/or for scientific research. 54. Signature of Patient (Signature by mark must be witnessed.) 55. Date

MM DD YYYY G. PRIVACY STATEMENT The collection of this information is authorized by Section 226A of the Social Security Act. The information provided will be used to determine if an individual is entitled to Medicare under the End Stage Renal Disease provisions of the law. The information will be maintained in system No. 09-70-0520, “End Stage Renal Disease Program Management and Medical Information System (ESRD PMMIS)”, published in the Federal Register, Vol. 67, No. 116, June 17, 2002, pages 41244-41250 or as updated and republished. Collection of your Social Security number is authorized by Executive Order 9397. Furnishing the information on this form is voluntary, but failure to do so may result in denial of Medicare benefits. Information from the ESRD PMMIS may be given to a congressional office in response to an inquiry from the congressional office made at the request of the individual; an individual or organization for research, demonstration, evaluation, or epidemiologic project related to the prevention of disease or disability, or the restoration or maintenance of health. Additional disclosures may be found in the Federal Register notice cited above. You should be aware that P.L.100-503, the Computer Matching and Privacy Protection Act of 1988, permits the government to verify information by way of computer matches. FORM CMS-2728-U3 (06/04) EF(03/2005) 661 LIST OF PRIMARY CAUSES OF END STAGE RENAL DISEASE

Item 15. Primary Cause of Renal Failure should be completed by the attending physician from the list below. Enter the ICD-9-CM code to indicate the primary cause of end stage renal disease. If there are several probable causes of renal failure, choose one as primary. Code effective as of September 2003.

DIABETES CYSTIC/HEREDITARY/CONGENITAL DISEASES 25040 Diabetes with renal manifestations Type 2 75313 Polycystic kidneys, adult type (dominant) 25041 Diabetes with renal manifestations Type 1 75314 Polycystic, infantile (recessive) 75316 Medullary cystic disease, including nephronophthisis GLOMERULONEPHRITIS 7595 Tuberous sclerosis 7598 Hereditary nephritis, Alport’s syndrome 5829 Glomerulonephritis (GN) 2700 Cystinosis (histologically not examined) 2718 Primary oxalosis 5821 Focal glomerulosclerosis, focal sclerosing GN 2727 Fabry’s disease 5831 Membranous nephropathy 7533 Congenital nephrotic syndrome 58321 Membranoproliferative GN type 1, diffuse MPGN 5839 Drash syndrome, mesangial sclerosis 58322 Dense deposit disease, MPGN type 2 75321 Congenital obstruction of ureterpelvic junction 58381 IgA nephropathy, Berger’s disease 75322 Congenital obstruction of uretrovesical junction (proven by immunofluorescence) 75329 Other Congenital obstructive uropathy 58382 IgM nephropathy (proven by immunofluorescence) 7530 Renal hypoplasia, dysplasia, oligonephronia 5834 With lesion of rapidly progressive GN 75671 Prune belly syndrome 5800 Post infectious GN, SBE 75989 Other (congenital malformation syndromes) 5820 Other proliferative GN NEOPLASMS/TUMORS SECONDARY GN/VASCULITIS 1890 Renal tumor (malignant) 7100 Lupus erythematosus, (SLE nephritis) 1899 Urinary tract tumor (malignant) 2870 Henoch-Schonlein syndrome 2230 Renal tumor (benign) 7101 Scleroderma 2239 Urinary tract tumor (benign) 28311 Hemolytic uremic syndrome 23951 Renal tumor (unspecified) 4460 Polyarteritis 23952 Urinary tract tumor (unspecified) 4464 Wegener’s granulomatosis 20280 Lymphoma of kidneys 58392 Nephropathy due to heroin abuse and related drugs 20300 Multiple myeloma 44620 Other Vasculitis and its derivatives 20308 Other immuno proliferative neoplasms 44621 Goodpasture’s syndrome (including light chain nephropathy) 58391 Secondary GN, other 2773 Amyloidosis 99680 Complications of transplanted organ unspecified INTERSTITIAL NEPHRITIS/PYELONEPHRITIS 99681 Complications of transplanted kidney 99682 Complications of transplanted liver 9659 Analgesic abuse 99683 Complications of transplanted heart 5830 Radiation nephritis 99684 Complications of transplanted lung 9849 Lead nephropathy 99685 Complications of transplanted bone marrow 5909 Nephropathy caused by other agents 99686 Complications of transplanted pancreas 27410 Gouty nephropathy 99687 Complications of transplanted intestine 5920 Nephrolithiasis 99689 Complications of other specified transplanted organ 5996 Acquired obstructive uropathy 5900 Chronic pyelonephritis, reflux nephropathy MISCELLANEOUS CONDITIONS 58389 Chronic interstitial nephritis 58089 Acute interstitial nephritis 28260 Sickle cell disease/anemia 28269 Sickle cell trait and other sickle cell (HbS/Hb other) 5929 Urolithiasis 64620 Post partum renal failure 27549 Other disorders of calcium metabolism 042 AIDS nephropathy 8660 Traumatic or surgical loss of kidney(s) HYPERTENSION/LARGE VESSEL DISEASE 5724 Hepatorenal syndrome 40391 Unspecified with renal failure 5836 Tubular necrosis (no recovery) 4401 Renal artery stenosis 59389 Other renal disorders 59381 Renal artery occlusion 7999 Etiology uncertain 59383 Cholesterol emboli, renal emboli

FORM CMS-2728-U3 (06/04) EF(03/2005) 662 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0448 ESRD DEATH NOTIFICATION END STAGE RENAL DISEASE MEDICAL INFORMATION SYSTEM 1. Patient’s Last Name First MI 2. Medicare Claim Number

3. Patient’s Sex 4. Date of Birth 5. Social Security Number a. ■ Male b. ■ Female ■■ _ _ / _ _ / _ _ _ _ Month M onth Day Day Year Year 6. Patient’s State of Residence 7. Place of Death 8. Date of Death a. ■ Hospital c. ■ Home e. ■ Other _ _ / _ _ / _ _ _ _ b. ■ Dialysis Unit d. ■ Nursing Home Month Day Year 9. Modality at Time of Death a. ■ Incenter Hemodialysis b. ■ Home Hemodialysis c. ■ CAPD d. ■ CCPD e. ■ Transplant f. ■ Other

10. Provider Name and Address (Street) 11. Provider Number

Provider Address (City/State)

12. Causes of Death (enter codes from list on back of form) a. Primary Cause _ _ _ b. Were there secondary causes? ■ No ■ Yes, specify: ______C. If cause is other (98) please specify:______■■ ■ ■■■ ■■■ ■■■ 13. Renal replacement therapy discontinued prior to death: ■ Yes ■ No 14. Was discontinuation of renal replacement therapy after patient/family request to stop If yes, check one of the following: dialysis? a. ■ Following HD and/or PD access failure b. ■ Following transplant failure ■ Yes ■ No c. ■ Following chronic failure to thrive d. ■ Following acute medical complication ■ Unknown ■ Not Applicable e. ■ Other f. Date of last dialysis treatment _ _ / _ _ / _ _ _ _ ■■ ■■ ■■■■ Month Day Year 15. If deceased ever received a transplant: 16. Was patient receiving Hospice care prior a. Date of most recent transplant _ _ / _ _ / _ _ _ _ ■ Unknown to death? Month Day Year b. Type of transplant received ■ Living Related ■ Living Unrelated ■ Deceased ■ Unknown ■ Yes ■ No c. Was graft functioning (patient not on dialysis) at time of death? ■ Yes ■ No ■ Unknown ■ Unknown

d. Did transplant patient resume chronic maintenance dialysis prior to death? ■ Yes ■ No ■ Unknown

17. Name of Physician (Please print complete name) 18. Signature of Person Completing This Form Date

This report is required by law (42, U.S.C. 426; 20 CFR 405, Section 2133). Individually identifiable patient information will not be disclosed except as provided for in the Privacy Act of 1974 (5 U.S.C. 5520; 45 CFR Part 5a).

Form CMS-2746-U2 (08/06) EF 08/2006 663 ESRD DEATH NOTIFICATION FORM LIST OF CAUSES

CARDIAC LIVER DISEASE 23 Myocardial infarction, acute 64 Hepatitis B 25 Pericarditis, incl. Cardiac tamponade 71 Hepatitis C 26 Atherosclerotic heart disease 65 Other viral hepatitis 27 Cardiomyopathy 66 Liver-drug toxicity 28 Cardiac arrhythmia 67 Cirrhosis 29 Cardiac arrest, cause unknown 68 Polycystic liver disease 30 Valvular heart disease 69 Liver failure, cause unknown or other 31 Pulmonary edema due to exogenous fluid 32 Congestive Heart Failure GASTRO-INTESTINAL 72 Gastro-intestinal hemorrhage VASCULAR 73 Pancreatitis 35 Pulmonary embolus 75 Perforation of peptic ulcer 36 Cerebrovascular accident including 76 Perforation of bowel (not 75) intracranial hemorrhage 37 Ischemic brain damage/Anoxic encephalopathy METABOLIC 38 Hemorrhage from transplant site 24 Hyperkalemia 39 Hemorrhage from vascular access 77 Hypokalemia 40 Hemorrhage from dialysis circuit 78 Hypernatremia 41 Hemorrhage from ruptured vascular aneurysm 79 Hyponatremia 42 Hemorrhage from surgery (not 38, 39, or 41) 100 Hypoglycemia 43 Other hemorrhage (not 38-42, 72) 101 Hyperglycemia 44 Mesenteric infarction/ischemic bowel 102 Diabetic coma 95 Acidosis INFECTION 33 Septicemia due to internal vascular access ENDOCRINE 34 Septicemia due to vascular access catheter 96 Adrenal insufficiency 45 Peritoneal access infectious complication, bacterial 97 Hypothyroidism 46 Peritoneal access infectious complication, fungal 103 Hyperthyroidism 47 Peritonitis (complication of peritoneal dialysis) 48 Central nervous system infection (brain abscess, OTHER meningitis, encephalitis, etc.) 80 Bone marrow depression 51 Septicemia due to peripheral vascular disease, 81 Cachexia/failure to thrive gangrene 82 Malignant disease, patient ever on 52 Septicemia, other Immunosuppressive therapy 61 Cardiac infection (endocarditis) 83 Malignant disease (not 82) 62 Pulmonary infection (pneumonia, influenza) 84 Dementia, incl. dialysis dementia, Alzheimer’s 63 Abdominal infection (peritonitis (not comp of PD), 85 Seizures perforated bowel, diverticular disease, gallbladder) 87 Chronic obstructive lung disease (COPD) 70 Genito-urinary infection (urinary tract infection, 88 Complications of surgery pyelonephritis, renal abscess) 89 Air embolism 104 Withdrawal from dialysis/uremia 90 Accident related to treatment 91 Accident unrelated to treatment 92 Suicide 93 Drug overdose (street drugs) 94 Drug overdose (not 92 or 93) 98 Other cause of death 99 Unknown

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0448. The time required to complete this information collection is estimated to average 30 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attn: PRA Reports Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Form CMS-2746-U2 (08/06) EF 08/2006 664 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0447 END STAGE RENAL DISEASE MEDICAL INFORMATION SYSTEM FOR THE PERIOD ESRD FACILITY SURVEY (DIALYSIS UNITS ONLY)

Facility Physical Address (If different than mailing address) Suite/Room Street City State/Zip Code

Number of Dialysis Stations: Facility Telephone: ( )

Facility Ownership Type: Profit Non-Profit

Facility Local/National Affiliation/Chain Information (i.e. Gambro, etc.)

Types of dialysis services offered: Incenter Hemodialysis Peritoneal Dialysis Home Hemodialysis Training

Does your facility offer a dialysis shift that starts at 5:00 p.m. or later? Yes No DIALYSIS PATIENTS AND TREATMENTS DIALYSIS PATIENTS

Additions During Survey Period Losses During Survey Period Trans- ferred Returned Recov- Received Trans- Dis- Other Started Restarted from after Deaths ered transferred to continued (LTFU) Patients Receiving Care for first other transplan- kidney plant other dial- dialysis Beginning of Survey Period time ever dialysis tation function unit ysis unit Total Incenter Home Fields 01 In- thru 02 center Home

01 02 03 04A 05A 06A 07A 08A 09A 10A 11A 12A 13A 04B 05B 06B 07B 08B 09B 10B 11B 12B 13B

Patients Receiving Care at End of Survey Period Total Total Incenter Self-Dialysis Training Incenter Home Dialysis Home Total Dialysis Dialysis Dialysis Patients

Hemo- Other Hemo- CAPD CCPD Other Fields 14 Hemo- CAPD CCPD Other Fields 21 Fields 20 Dialysis Dialysis thru 19 Dialysis thru 24 and 25

14 15 16 17 18 19 20 21 22 23 24 25 26

Patient Eligibility Status Hemodialysis Patients Dialyzing Vocational Rehabilitation End of Survey Period More Than 4 Times Per Week Patients Patients Currently Medicare Setting Day Nocturnal Patients Patients receiving attending enrolled applica- Non- Employed aged 18 services school in tion Medicare Incenter full-time or through 54 from Voc full-time or Medicare pending part-time Rehab part-time Home

30A 31A 27 28 29 30B 31B 32 33 34 35

TREATMENT AND STAFFING Staffing Number of Staff Number of Open Pos. Incenter Dialysis Treatments Position Full Time Part Time Full Time Part Time (Include Training Treatments) a. RNs b. LPN/LVNs Hemodialysis Other c. PCTs d. APNs e. Dietitians f. Social Workers 36 37 38 39 40 41

COMPLETED BY (Name) DATE TITLE TELEPHONE NO.

REMARKS REGARDING INFORMATION PROVIDED ON THIS SURVEY SHOULD BE ENTERED ON THE LAST PAGE OF THE SURVEY This report is required by law (42 USC 426; 42 CFR 405.2133). Individually identifiable patient information will not be disclosed except as provided for in the Privacy Act of 1974 (5 USC 5520; 45 CFR, Part 5a). Form CMS-2744A (02/04)

665 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0447 END STAGE RENAL DISEASE MEDICAL INFORMATION SYSTEM FOR THE PERIOD ESRD FACILITY SURVEY (TRANSPLANT CENTERS ONLY)

KIDNEY TRANSPLANTS PERFORMED PATIENTS TRANSPLANTED AND DONOR TYPE TO BE COMPLETED BY KIDNEY TRANSPLANT CENTERS ONLY

Eligibility Status of Patients Patients Transplanted at this Facility who During the Survey Period received transplant Currently Medicare Non-Medicare at this enrolled applica- facility in tion U.S. Res. Other Medicare pending

42 43 44 45 46

Transplant Procedures Performed Patients Awaiting at This Facility Transplant Living Living Total Related Unrelated Deceased Fields 47 Dialysis Nondialysis Donor Donor Donor thru 49

47 48 49 50 51 52

REMARKS/COMMENTS

COMPLETED BY (Name) DATE TITLE TELEPHONE NO.

This report is required by law (42 USC 426; 42 CFR 405.2133). Individually identifiable patient information will not be disclosed except as provided for in the Privacy Act of 1974 (5 USC 5520; 45 CFR, Part 5a). Form CMS-2744B (02/04)

666 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS FOR MEDICARE & MEDICAID SERVICES OMB No. 0938-0046 END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION A. COMPLETE FOR ALL ESRD PATIENTS Check one: Initial Re-entitlement Supplemental 1. Name (Last, First, Middle Initial)

2. Medicare Claim Number 3. Social Security Number 4. Date of Birth (mm/dd/yyyy)

5. Patient Mailing Address (Include City, State and Zip) 6. Phone Number (including area code)

16. Employment Status (6 mos prior and 17. Co-Morbid Conditions (Check all that apply currently and/or during last 10 years) *See instructions current status) a. Congestive heart failure n. Malignant neoplasm, Cancer b. Atherosclerotic heart disease ASHD o. Toxic nephropathy c. Other cardiac disease p. Alcohol dependence Unemployed d. Cerebrovascular disease, CVA, TIA* q. Drug dependence* e. Peripheral vascular disease* r. Inability to ambulate Employed Full Time f. History of hypertension s. Inability to transfer Employed Part Time g. Amputation t. Needs assistance with daily activities Homemaker h. Diabetes, currently on insulin u. Institutionalized Retired due to Age/Preference i. Diabetes, on oral medications 1. Assisted Living j. Diabetes, without medications 2. Nursing Home Retired (Disability) k. Diabetic retinopathy 3. Other Institution Medical Leave of Absence l. Chronic obstructive pulmonary disease v. Non-renal congenital abnormality Student m. Tobacco use (current smoker) w. None 18. Prior to ESRD therapy: a. Did patient receive exogenous erythropoetin or equivalent? Yes No Unknown If Yes, answer: <6 months 6-12 months >12 months b. Was patient under care of a nephrologist? Yes No Unknown If Yes, answer: <6 months 6-12 months >12 months c. Was patient under care of kidney dietitian? Yes No Unknown If Yes, answer: <6 months 6-12 months >12 months d. What access was used on first outpatient dialysis: AVF Graft Catheter Other If not AVF, then: Is maturing AVF present? Yes No Is maturing graft present? Yes No 19. Laboratory Values Within 45 Days Prior to the Most Recent ESRD Episode. (Lipid Profile within 1 Year of Most Recent ESRD Episode). LABORATORY TEST VALUE DATE LABORATORY TEST VALUE DATE a.1. Serum Albumin (g/dl) d. HbA1c % a.2. Serum Albumin Lower Limit e. Lipid Profile TC a.3. Lab Method Used (BCG or BCP) LDL b. Serum Creatinine (mg/dl) HDL c. Hemoglobin (g/dl) TG B. COMPLETE FOR ALL ESRD PATIENTS IN DIALYSIS TREATMENT 20. Name of Dialysis Facility 21. Medicare Provider Number (for item 20)

22. Primary Dialysis Setting 23. Primary Type of Dialysis Home Dialysis Facility/Center SNF/Long Term Care Facility Hemodialysis (Sessions per week /hours per session ) CAPD CCPD Other 24. Date Regular Chronic Dialysis Began (mm/dd/yyyy) 25. Date Patient Started Chronic Dialysis at Current Facility (mm/dd/yyyy)

26. Has patient been informed 27. If patient NOT informed of transplant options, please check all that apply: of kidney transplant options? Medically unfit Patient declines information Unsuitable due to age Yes No Patient has not been assessed Psychologically unfit Other

FORM CMS-2728-U3 (08/15) 667 1 C. COMPLETE FOR ALL KIDNEY TRANSPLANT PATIENTS 28. Date of Transplant (mm/dd/yyyy) 29. Name of Transplant Hospital 30. Medicare Provider Number for Item 29

Date patient was admitted as an inpatient to a hospital in preparation for, or anticipation of, a kidney transplant prior to the date of actual transplantation. 31. Enter Date (mm/dd/yyyy) 32. Name of Preparation Hospital 33. Medicare Provider number for Item 32

34. Current Status of Transplant (if functioning, skip items 36 and 37) 35. Type of Donor: Functioning Non-Functioning Deceased Living Related Living Unrelated 36. If Non-Functioning, Date of Return to Regular Dialysis (mm/dd/yyyy) 37. Current Dialysis Treatment Site Home Dialysis Facility/Center SNF/Long Term Care Facility D. COMPLETE FOR ALL ESRD SELF-DIALYSIS TRAINING PATIENTS (MEDICARE APPLICANTS ONLY) 38. Name of Training Provider 39. Medicare Provider Number of Training Provider (for Item 38)

40. Date Training Began (mm/dd/yyyy) 41. Type of Training Hemodialysis a. Home b. In Center CAPD CCPD Other 42. This Patient is Expected to Complete (or has completed) Training 43. Date When Patient Completed, or is Expected to Complete, Training and will Self-dialyze on a Regular Basis. (mm/dd/yyyy) Yes No I certify that the above self-dialysis training information is correct and is based on consideration of all pertinent medical, psychological, and sociological factors as reflected in records kept by this training facility. 44. Printed Name and Signature of Physician personally familiar with the patient’s training 45. UPIN of Physician in Item 44 a.) Printed Name b.) Signature c.) Date (mm/dd/yyyy)

E. PHYSICIAN IDENTIFICATION 46. Attending Physician (Print) 47. Physician’s Phone No. (include Area Code) 48. UPIN of Physician in Item 46

PHYSICIAN ATTESTATION I certify, under penalty of perjury, that the information on this form is correct to the best of my knowledge and belief. Based on diagnostic tests and laboratory findings, I further certify that this patient has reached the stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplant to maintain life. I understand that this information is intended for use in establishing the patient’s entitlement to Medicare benefits and that any falsification, misrepresentation, or concealment of essential information may subject me to fine, imprisonment, civil penalty, or other civil sanctions under applicable Federal laws. 49. Attending Physician’s Signature of Attestation (Same as Item 46) 50. Date (mm/dd/yyyy)

51. Physician Recertification Signature 52. Date (mm/dd/yyyy)

53. Remarks

F. OBTAIN SIGNATURE FROM PATIENT I hereby authorize any physician, hospital, agency, or other organization to disclose any medical records or other information about my medical condition to the Department of Health and Human Services for purposes of reviewing my application for Medicare entitlement under the Social Security Act and/or for scientific research. 54. Signature of Patient (Signature by mark must be witnessed.) 55. Date (mm/dd/yyyy)

G. PRIVACY STATEMENT

The collection of this information is authorized by Section 226A of the Social Security Act. The information provided will be used to determine if an individual is entitled to Medicare under the End Stage Renal Disease provisions of the law. The information will be maintained in system No. 09-70- 0520, “End Stage Renal Disease Program Management and Medical Information System (ESRD PMMIS)”, published in the Federal Register, Vol. 67, No. 116, June 17, 2002, pages 41244-41250 or as updated and republished. Collection of your Social Security number is authorized by Executive Order 9397. Furnishing the information on this form is voluntary, but failure to do so may result in denial of Medicare benefits. Information from the ESRD PMMIS may be given to a congressional office in response to an inquiry from the congressional office made at the request of the individual; an individual or organization for research, demonstration, evaluation, or epidemiologic project related to the prevention of disease or disability, or the restoration or maintenance of health. Additional disclosures may be found in the Federal Register notice cited above. You should be aware that P.L.100-503, the Computer Matching and Privacy Protection Act of 1988, permits the government to verify information by way of computer matches.

668FORM CMS-2728-U3 (08/15) 2 INSTRUCTIONS FOR COMPLETION OF END STAGE RENAL DISEASE MEDICAL EVIDENCE REPORT MEDICARE ENTITLEMENT AND/OR PATIENT REGISTRATION For whom should this form be completed: The form should be completed for all patients in this category even if the patient dies within this time period. This form SHOULD NOT be completed for those patients who are in acute renal failure. Acute renal failure is a condition in Re-entitlement which kidney function can be expected to recover after a For beneficiaries who have already been entitled to ESRD short period of dialysis, i.e., several weeks or months. Medicare benefits and those benefits were terminated This form MUST BE completed within 45 days for ALL because their coverage stopped 3 years post-transplant but patients beginning any of the following: now are again applying for Medicare ESRD benefits because they returned to dialysis or received another kidney Check the appropriate block that identifies the reason for transplant. submission of this form. For beneficiaries who stopped dialysis for more than 12 Initial months, have had their Medicare ESRD benefits terminated For all patients who initially receive a kidney transplant and now returned to dialysis or received a kidney transplant. instead of a course of dialysis. For patients for whom a These patients will be reapplying for Medicare ESRD benefits. regular course of dialysis has been prescribed by a physician Supplemental because they have reached that stage of renal impairment that a kidney transplant or regular course of dialysis is Patient has received a transplant or trained for self-care necessary to maintain life. The first date of a regular course dialysis within the first 3 months of the first date of dialysis of dialysis is the date this prescription is implemented and initial form was submitted. whether as an inpatient of a hospital, an outpatient in a dialysis center or facility, or a home patient.

All items except as follows: To be completed by the attending physician, head nurse, or social worker involved in this patient’s treatment of renal disease. Items 15, 17-18, 26-27, 49-50: To be completed by the attending physician. Item 44: To be signed by the attending physician or the physician familiar with the patient’s self-care dialysis training. Items 54 and 55: To be signed and dated by the patient.

1. Enter the patient’s legal name (Last, first, middle initial). 10. Check the appropriate block(s) to identify race. Definitions of Name should appear exactly the same as it appears on the racial categories for Federal statistics are as follows: patient’s social security or Medicare card. White—A person having origins in any of the original white 2. If the patient is covered by Medicare, enter his/her Medicare peoples of Europe, the Middle East or North Africa. claim number as it appears on his/her Medicare card. Black or African American—A person having origins in any 3. Enter the patient’s own social security number. This number of the black racial groups of Africa. This includes native-born can be verified from his/her social security card. Black Americans, Africans, Haitians and residents of non- 4. Enter patient’s date of birth (2-digit Month, Day, and 4-digit Spanish speaking Caribbean Islands of African descent. Year). Example 07/25/1950. American Indian/Alaska Native—A person having origins in 5. Enter the patient’s mailing address (number and street or any of the original peoples of North America and South post office box number, city, state, and ZIP code.) America (including Central America) and who maintains Tribal affiliation or community attachment. Print the name of 6. Enter the patient’s home area code and telephone number. the enrolled or principal tribe to which the patient claims to 7. Check the appropriate block to identify sex. be a member. 8. Check the appropriate block to identify ethnicity. Definitions Asian—A person having origins in any of the original peoples of the ethnicity categories for Federal statistics are as follows: of the Far East, Southeast Asia or the Indian subcontinent Not Hispanic or Latino—A person of culture or origin not including, for example, Cambodia, China, India, Japan, Korea, described below, regardless of race. Malaysia, Pakistan, the Philippine Islands, Thailand and Vietnam. Hispanic or Latino—A person of Cuban, Puerto Rican, or Mexican culture or origin regardless of race. Please complete Native Hawaiian or Other Pacific Islander—A person Item 9 and provide the country, area of origin, or ancestry to having origins in any of the original peoples of Hawaii, which the patient claims to belong. Guam, Samoa, or other Pacific Islands. Please complete Item 9 and provide the country, area of origin, or ancestry to which 9. Country/Area of origin or ancestry—Complete if information the patient claims to belong. is available or if directed to do so in question 8.

DISTRIBUTION OF COPIES: • Forward one copy of this form to the Social Security office servicing the claim. • Forward one copy of this form to the ESRD Network Organization. • Retain one copy of this form in the patient’s medical records file. According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information is 0938-0046. The time required to complete this information collection estimated to average 45 minutes per response, including the time to review instructions, search existing data resources, and gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, Attention: PRA Reports Clearance Officer, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Please do not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA Reports Clearance Office. Please note t h a t any correspondence not pertaining to the information collection burden approved under the associated OMB control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding where to submit your documents, please contact 1-800-MEDICARE.

Form CMS‐2728‐U3 (08/15) 3 669

11. Check the appropriate yes or no block to indicate if patient is 19a1. Enter the serum albumin value (g/dl) and date test was taken. applying for ESRD Medicare. Note: Even though a person This value and date must be within 45 days prior to first may already be entitled to general Medicare coverage, dialysis treatment or kidney transplant. he/she should reapply for ESRD Medicare coverage. 19a2. Enter the lower limit of the normal range for serum albumin 12. Check all the blocks that apply to this patient’s current from the laboratory which performed the serum albumin test medical insurance status. entered in 19a1. Medicaid—Patient is currently receiving State Medicaid 19a3. Enter the serum albumin lab method used (BCG or BCP). benefits. 19b. Enter the serum creatinine value (mg/dl) and date test was Medicare—Patient is currently entitled to Federal Medicare taken. THIS FIELD MUST BE COMPLETED. Value must be benefits. within 45 days prior to first dialysis treatment or kidney Employer Group Health Insurance—Patient receives medical transplant. benefits through an employee health plan that covers 19c. Enter the hemoglobin value (g/dl) and date test was taken. employees, former employees, or the families of employees o This value and date must be within 45 days prior to the first former employees. dialysis treatment or kidney transplant. DVA—Patient is receiving medical care from a Department of 19d. Enter the HbA1c value and the date the test was taken. The Veterans Affairs facility. date must be within 1 year prior to the first dialysis Medicare Advantage—Patient is receiving medical benefits treatment or kidney transplant. under a Medicare Advantage organization. 19e. Enter the Lipid Profile values and date test was taken. These Other Medical Insurance—Patient is receiving medical values: TC–Total Cholesterol; LDL–LDL Cholesterol; HDL–HDL benefits under a health insurance plan that is not Medicare, Cholesterol; TG–Triglycerides, and date must be within 1 year Medicaid, Department of Veterans Affairs, HMO/M+C prior to the first dialysis treatment or kidney transplant. organization, nor an employer group health insurance plan. 20. Enter the name of the dialysis facility where patient is Examples of other medical insurance are Railroad Retirement currently receiving care and who is completing this form for and CHAMPUS beneficiaries. patient. None—Patient has no medical insurance plan. 21. Enter the 6-digit Medicare identification code of the dialysis 13. Enter the patient’s most recent recorded height in inches OR facility in item 20. centimeters at time form is being completed. If entering 22. If the person is receiving a regular course of dialysis height in centimeters, round to the nearest centimeter. treatment, check the appropriate anticipated long-term Estimate or use last known height for those unable to be treatment setting at the time this form is being completed. measured. (Example of inches - 62. DO NOT PUT 5’2”) NOTE: 23. If the patient is, or was, on regular dialysis, check the For amputee patients, enter height prior to amputation. anticipated long-term primary type of dialysis: 14. Enter the patient’s most recent recorded dry weight in Hemodialysis, (enter the number of sessions prescribed per pounds OR kilograms at time form is being completed. If week and the hours that were prescribed for each session), entering weight in kilograms, round to the nearest kilogram. CAPD (Continuous Ambulatory Peritoneal Dialysis) and CCPD NOTE: For amputee patients, enter actual dry weight. (Continuous Cycling Peritoneal Dialysis), or Other. Check only one block. NOTE: Other has been placed on this form to be 15. To be completed by the attending physician. Enter the used only to report IPD (Intermittent Peritoneal Dialysis) and ICD10-CM Code to indicate the primary cause of end stage any new method of dialysis that may be developed prior to the renal disease. renewal of this form by Office of Management and Budget. 16. Check the first box to indicate employment status 6 months 24. Enter the date (month, day, year) that a “regular course of prior to renal failure and the second box to indicate current chronic dialysis” began. The beginning of the course of employment status. Check only one box for each time dialysis is counted from the beginning of regularly scheduled period. If patient is under 6 years of age, leave blank. dialysis necessary for the treatment of end stage renal 17. To be completed by the attending physician. Check all co- disease (ESRD) regardless of the dialysis setting. The date of morbid conditions that apply. the first dialysis treatment after the physician has determined *Cerebrovascular Disease includes history of that this patient has ESRD and has written a prescription for stroke/cerebrovascular accident (CVA) and transient ischemic a “regular course of dialysis” is the “Date Regular Chronic attack (TIA). Dialysis Began” regardless of whether this prescription was implemented in a hospital/ inpatient, outpatient, or home *Peripheral Vascular Disease includes absent foot pulses, setting and regardless of any acute treatments received prior prior typical claudication, amputations for vascular disease, to the implementation of the prescription. gangrene and aortic aneurysm. NOTE: For these purposes, end stage renal disease means *Drug dependence means dependent on illicit drugs. irreversible damage to a person’s kidneys so severely affecting 18. Prior to ESRD therapy, check the appropriate box to indicate his/her ability to remove or adjust blood wastes that in order to whether the patient received exogenous erythropoietin (EPO) maintain life he or she must have either a course of dialysis or a or equivalent, was under the care of a nephrologist and/or kidney transplant to maintain life. was under the care of a kidney dietitian. Provide vascular If re-entering the Medicare program, enter beginning date of the access information as to the type of access used (Arterio- current ESRD episode. Note in Remarks, Item 53, that patient is Venous Fistula (AVF), graft, catheter (including port device) restarting dialysis. or other type of access) when the patient first received outpatient dialysis. If an AVF access was not used, was a 25. Enter date patient started chronic dialysis at current facility of maturing AVF or graft present? dialysis services. In cases where patient transferred to current dialysis facility, this date will be after the date in Item NOTE: For those patients re-entering the Medicare program after 24. benefits were terminated, Items 19a thru 19c should contain initial laboratory values within 45 days prior to the most recent 26. Enter whether the patient has been informed of their ESRD episode. Lipid profiles and HbA1c should be within 1 year options for receiving a kidney transplant. of the most recent ESRD episode. Some tests may not be required 27. If the patient has not been informed of their options for patients under 21 years of age. (answered “no” to Item 26), then enter all reasons why a

Form CMS‐2728‐U3 (08/15) 4

670 kidney transplant was not an option for this patient at this patient’s renal treatment at the time this form is completed. time. 47. Enter the area code and telephone number of the physician 28. Enter the date(s) of the patient’s kidney transplant(s). If who is supervising the patient’s renal treatment at the time reentering the Medicare program, enter current transplant this form is completed. date. 48. Enter the physician’s UPIN assigned by CMS. 29. Enter the name of the hospital where the patient received a A system of physician identifiers is mandated by Section 9202 kidney transplant on the date in Item 28. of the Consolidated Omnibus Budget Reconciliation Act of 30. Enter the 6-digit Medicare identification code of the hospital 1985. It requires a unique identifier for each physician who in Item 29 where the patient received a kidney transplant on provides services for which Medicare payment is made. An the date entered in Item 28. identifier is assigned to each physician regardless of his or her 31. Enter date patient was admitted as an inpatient to a hospital practice configuration. The UPIN is established in a national in preparation for, or anticipation of, a kidney transplant Registry of Medicare Physician Identification and Eligibility prior to the date of the actual transplantation. This includes Records (MPIER). Transamerica Occidental Life Insurance hospitalization for transplant workup in order to place the Company is the Registry Carrier that establishes and patient on a transplant waiting list. maintains the national registry of physicians receiving Part Medicare payment. Its address is: UPIN Registry, Transamerica 32. Enter the name of the hospital where patient was admitted Occidental Life, P.O. Box 2575, Los Angeles, CA 90051-0575. as an inpatient in preparation for, or anticipation of, a kidney transplant prior to the date of the actual 49. To be signed by the physician supervising the patient’s kidney transplantation. treatment. Signature of physician identified in Item 46. A stamped signature is unacceptable. 33. Enter the 6-digit Medicare identification number for hospital in Item 32. 50. Enter date physician signed this form. 34. Check the appropriate functioning or non-functioning block. 51. To be signed by the physician who is currently following the patient. If the patient had decided initially not to file an 35. Enter the type of kidney transplant organ donor, Deceased, application for Medicare, the physician will be re-certifying Living Related or Living Unrelated, that was provided to the that the patient is end stage renal, based on the same patient. medical evidence, by signing the copy of the CMS-2728 that 36. If transplant is nonfunctioning, enter date patient returned was originally submitted and returned to the provider. If you to a regular course of dialysis. If patient did not stop dialysis do not have a copy of the original CMS-2728 on file, post-transplant, enter transplant date. complete a new form. 37. If applicable, check where patient is receiving dialysis 52. The date physician re-certified and signed the form. treatment following transplant rejection. A nursing home or 53. This remarks section may be used for any necessary skilled nursing facility is considered as home setting comments by either the physician, patient, ESRD Network or social security field office. Self-dialysis Training Patients (Medicare Applicants 54. The patient’s signature authorizing the release of Only) information to the Department of Health and Human Normally, Medicare entitlement begins with the third month Services must be secured here. If the patient is unable to after the month a patient begins a regular course of dialysis sign the form, it should be signed by a relative, a person treatment. This 3-month qualifying period may be waived if a assuming responsibility for the patient or by a survivor. patient begins a self-dialysis training program in a Medicare 55. The date patient signed form. approved training facility and is expected to self-dialyze after the completion of the training program. Please complete items 38-43 if the patient has entered into a self- dialysis training program. Items 38-43 must be completed if the patient is applying for a Medicare waiver of the 3-month qualifying period for dialysis benefits based on participation in a self-care dialysis training program. 38. Enter the name of the provider furnishing self-care dialysis training. 39. Enter the 6-digit Medicare identification number for the training provider in Item 38. 40. Enter the date self-dialysis training began. 41. Check the appropriate block which describes the type of self- care dialysis training the patient began. If the patient trained for hemodialysis, enter whether the training was to perform dialysis in the home setting or in the facility (in center). If the patient trained for IPD (Intermittent Peritoneal Dialysis), report as Other. 42. Check the appropriate block as to whether or not the physician certifies that the patient is expected to complete the training successfully and self-dialyze on a regular basis. 43. Enter date patient completed or is expected to complete self-dialysis training. 44. Enter printed name and signature of the attending physician or the physician familiar with the patient’s self-care dialysis training. 45. Enter the Unique Physician Identification Number (UPIN) of physician in Item 44. (See Item 48 for explanation of UPIN.) 46. Enter the name of the physician who is supervising the

Form CMS‐2728‐U3 (08/15) 5 671 United States Renal Data System (USRDS) International Data Collection Form This form is designed to solicit information on the population of End-Stage Renal Disease (ESRD) patients in your country who are receiving renal replacement therapy (RRT). The information you provide will be returned to you along with comparable information from other countries participating in this voluntary effort.

If data are not available for all years, please include data for the most recent year(s). If you cannot provide data in the age and sex categories listed, please provide the total numbers. The format has been created to more clearly separate incident and prevalent population counts from transplant counts.

A) Population: the total general population of your country for the C.3) All dialysis patients. C.2. and C.3. should sum to C.1. unless there years that ESRD data will be provided. are lost-to-follow-up patients. If there are lost-to-follow-up patients, please note this fact and whether these patients are captured in C.2. B.1) Incidence: the count of patients who start any form of renal replacement therapy during the year. These are first-time patients only; patients who start dialysis after a failed transplant, for example, C.4) All patients treated with in-center hemodialysis as of December 31 should not be included. of the indicated year.

B.2) The subset of total incident patients whose failure is due to C.5) All patients treated with CAPD, APD, or IPD as of December 31 of diabetic nephropathy. Subtracting B2 from B1 should give the total the indicated year. number of incident patients for all non-diabetic nephropathy causes. C.6) All patients treated with home hemodialysis as of December 31.

C) Prevalence: the point prevalent count of patients at the end of the calendar year (December 31). D) Kidney transplant activity: This is meant to be a count of transplants, not transplanted patients. If a patient receives multiple transplants C.1) All patients on some form of ESRD treatment: dialysis and kidney during the year, all should be counted. If you report only transplanted transplantation. patients, please provide these numbers and note that they refer to patients. D.1 (deceased donor [cadaveric] transplants), D.2 (living donor C.2) Patients with a functioning kidney transplant as of December 31 transplants), and D.3 (unknown donor type) should sum to the total for the indicated year. number of transplants.

672 A) Total General Population of the Country/Region Population: the total general population of your country for the years indicated, or most recent available.