1. Page 1 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov End Stage Renal Disease (ESRD) http://www.hcfa.gov/medicare/esrdpage.htm http://www.hcfa.gov/quality/qlty%2D5d.htm Standard Information Management System (SIMS) http://www.simsproject.com http://www.esrdnetwork6.org Vital Information System to Improve Outcomes in Nephrology (VISION) HCFA / ESRD E-Reporting based on HL7 v3 XML Technology XML based Data Collection / ETL Tool soon http://www.metaintegration.net/HCFA Contacts @ HCFAContacts @ Meta Integration Cyrus KarimianCKarimian@hcfa.gov Bill Le Clairleclair@metaintegration.com Denis StrickerDStricker@hcfa.gov Christian Bremeaubremeau@metaintegration.com

2. Page 2 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA ESRD Network SOW Background The Statement of Work (SOW) delineates the activities to be conducted by each End Stage Renal Disease (ESRD) Network Organization (Network) to meet the requirements of section 1881(c) of the Social Security Act; the Health Care Financing Administration's (HCA's) Health Care Quality Improvement Program (HCQIP); and other directives related to improving the quality of care of patients with ESRD. The statute, regulations, the ESRD Network Organizations manual, and other HCFA instructions provide additional detail concerning Network functions, activities, and responsibilities.

3. Page 3 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA ESRD Network SOW Goals Improve the quality of health care services and quality of life for ESRD beneficiaries; Improve data reliability, validity, and reporting among ESRD providers/facilities, Networks and HCFA (or other appropriate agency); Establish and improve partnerships and cooperative activities among and between the ESRD Networks, Peer Review Organizations (PROs), State Survey Agencies, ESRD providers/facilities, ESRD facility owners, and professional groups.

4. Page 4 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA ESRD Network SOW Information Management The Network shall be required to utilize the Standard Information Management System (SIMS) to support Network data processing, information management and reporting contractual requirements to HCFA. HCFA is redesigning the current Renal Beneficiary and Utilization System (REBUS). The new system will be named the Renal Management Information System (REMIS). The Network shall be required to utilize REBUS or REMIS as directed by HCFA.

5. Page 5 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD / SIMS Responsibilities The Network's responsibilities for data processing, information management and reporting are: –To have sufficient system capacity with the appropriate computer hardware and software to carry out its contractual responsibilities; –To effectively manage the collection, validation, storage and use of data, including data provided by HCFA, for review, profiling, pattern analysis, and sharing with the HCFA RO and State Survey Agency for use in its ESRD Medicare survey and certification activities; –To ensure timely and accurate reporting by the providers/facilities; –To maintain an ESRD patient and facility database and ensure the integrity and accuracy of the databases; and –To ensure the quality and accuracy of the data submitted to HCFA for inclusion in the ESRD Program Management and Medical Information System (PMMIS) and the United States Renal Data System (USRDS).

6. Page 6 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD / SIMS System Capacity The Network shall maintain a system that provides the capacity to meet its contractual responsibilities for data collection, validation, entry, retrieval, profiling, analysis, and reporting, and for electronic data interchange. The system, at a minimum, shall utilize and consist of the following: –SIMS software, and program documentation, for the entry and transmission of the HCFA ESRD forms described in section C.5.E.; –HCFA approved software for the entry and transmission of clinical performance measures described in section C.2.C.; –Internet enabled electronic mail capability compatible with HCFA, including the ability to send and receive attachments; –Dial-in capability for connection to REBUS and HCFA compatible web browser access for connection to REMIS; –Office automation software compatible with the HCFA standard; –HCFA supplied or other statistical software for data analysis and profile analysis including profiling patients and facilities by county to facilitate disaster planning and other studies; –Provisions for disaster recovery of the databases and data system; and –Sufficient hardware to run the above software applications.

7. Page 7 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD / SIMS Database Management The Network shall maintain a patient database containing the minimum/ critical data elements listed in the Draft ESRD Network Organizations Manual instructions. The Network shall perform the following tasks related to its patient database: –The Networks shall consistently update the SIMS central repository based on data received from the providers/facilities. HCFA will receive a data feed from the SIMS central repository on a regularly scheduled basis to obtain an update of the Networks patient data for REBUS/REMIS. –Upon notification from HCFA either by hardcopy or electronically through REBUS/REMIS, update the Network's patient database with valid changes to important data elements (e.g., beneficiary name, date of birth, Health Insurance Claim Number (HICN) and Beneficiary Identification Code (BIC)). Through SIMS, the Network shall also maintain a facility database containing the minimum data elements listed in the Draft ESRD Network Organizations Manual instructions. HCFA has the capacity to create data files and labels, and to verify data for the national listing, directly from the SIMS system. HCFA will give the Networks two weeks notice prior to taking these actions so that Networks can properly schedule their system updates for the date the file is created.

8. Page 8 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD / SIMS Collection, Validation & Maintenance of HCFA ESRD Forms (Introduction) The Network shall obtain completed HCFA ESRD forms from each ESRD provider/facility in the Network area. The Network will also include all voluntarily submitted forms from the non-Medicare Department of Veterans Affairs (DVA) facilities, and other institutions such as prisons and nursing homes. These forms contain patient specific information necessary for the operation of the national ESRD program. The HCFA ESRD forms and their facility computer generated equivalents include the following: –HCFA-2728-U4 - ESRD Medical Evidence Report Medicare Entitlement and/or Patient Registration (completed on each incident ESRD patient); –HCFA-2744 - ESRD Facility Survey (completed annually); –HCFA-2746 - ESRD Death Notification (or computerized facility generated Death Notification form) (completed within 30 days of the date of death); –HCFA-820 - In-Center Hemodialysis (HD) Clinical Performance Measures Data Collection Form; and –HCFA-821 - Peritoneal Dialysis (PD) Clinical Performance Measures Data Collection Form.

9. Page 9 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD / SIMS Collection, Validation & Maintenance of HCFA ESRD Forms (VISION) It is anticipated the: Vital Information System to Improve Outcomes in Nephrology (VISION) project will be rolled out during this contract period, with National Implementation slated for the first quarter of calendar year 2001. However, until such time as the HCFA requires electronic reporting from all dialysis facilities for all patients, it will be on a voluntary basis. At that time, the Networks will be responsible for validating the data from the facilities. Monitoring the accuracy and completeness of reports, and the validation of facility-level patient data are critical roles in assuring the integrity of the patient tracking system. Similarly, capturing data forms on all incident cases requires a mechanism for cross-checking so facilities can query and detect unreported forms. As VISION is implemented, the activities specified below will need to be retained in a format that is consistent with migration from hardcopy to electronic reporting.

10. Page 10 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD / SIMS Collection, Validation & Maintenance of HCFA ESRD Forms (Activities) The Network shall conduct activities to ensure that the data required on the forms are collected, completed, and validated in accordance with Draft ESRD Network Organizations Manual instructions, and the ESRD Program Instruction Manual for Renal Providers. These activities include the following: –Review forms received for accuracy and completeness and return to the provider/facility (or otherwise query the provider/facility) for correction or completion of those forms with missing or inaccurate data. –Receive and process the ESRD Medical Evidence Report, Medicare Entitlement and/or Patient Registration form (HCFA-2728-U4). –Process and transmit the information on HCFA-2728 and HCFA-2746 forms directly to the HCFA Data Center via SIMS. –Process and transmit the information on the HCFA-2744 form directly to the HCFA Data Center via SIMS by the fifth working day in April. –Transmit corrections on the HCFA-2744 form by hard copy or through SIMS by the third Friday in May. –Maintain a file of all HCFA ESRD hardcopy forms that are processed for at least two years.

11. Page 11 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD Data Flow The big picture… In-Center Hemodialysis (HD) Clinical Performance Measures Data Collection Form 2000, Form HCFA-820 Peritoneal Dialysis (PD) Clinical Performance Measures Data Collection Form 2000 Form HCFA-821 ESRD Beneficiary Selection (Home Patients Only) Form HCFA-382 ESRD Medical Information System Facility Survey Part One: Dialysis Part Two: Kidney Transplants Form HCFA-2744 ESRD Medical Evidence Report Medicare Entitlement And/Or Patient Registration Form HCFA-2728-U3 Dialysis Facility (DF) Clinical Performance Measures Data Collection Form 2000 Form HCFA-??? Patient Death Form HCFA-2746 Patient Specific Information Form SIMS-??? Facility Specific Information Form SIMS-??? Social Security Administration (SSA) Health Care Financing Administration (HCFA) End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility Transforming the ESRD Reporting Process to HCFA from Paper Forms to HL7 v3 XML based E-reporting

12. Page 12 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov Network #20 … HCFA / ESRD Data Flow The SIMS front end HCFA-2744 HCFA-2728-U3 HCFA-2746 End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility Overnight Updates … Network #02 Network #01 Health Care Financing Administration (HCFA) End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility Reporting HCFA (Paper) Forms MS SQL Server Databases Replication SIMS Networks (geographically distributed) IBM Model 2.04 Databases

13. Page 13 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD Data Flow Inside HCFA Today… Health Care Financing Administration (HCFA) IBM Model 2.04 MS SQL Server Social Security Administration (SSA)

14. Page 14 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov Health Care Financing Administration (HCFA) HCFA / ESRD Data Flow Inside HCFA Tomorrow… IBM Model 2.04 Oracle 8i Oracle Business Intelligence (BI) & Knowledge Management (KM) Solutions: Data Warehousing Data Mining OLAP Auxiliary ESRD Specialized Databases Very limited and primitive had-hoc query and reports on the IBM mainframe (no need for legacy software migration, replaced by Oracle BI & KM tools: DW, DM, OLAP). Legacy Migration ETL Updates ETL Updates ETL

15. Page 15 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD Data Flow Long Term Objective… End Stage Renal Disease (ESRD) Facility Health Care Financing Administration (HCFA) MS SQL Server RDBMS ? Data Extraction, Transformation & Load (ETL) Electronic Data Interchange (EDI) over Secure Internet (based on XML) Do they have a database ? Is HL7 v3 XML Ready ? Are they connected on internet / dialups ? How about the security of the medical information ?

16. Page 16 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD Data Flow The VISION Data Collection Tool (Vital Information System to Improve Outcomes in Nephrology) End Stage Renal Disease (ESRD) Facility VISION Data Collection Tool (Windows Standalone Utility) HCFA-2744HCFA-2728-U3HCFA-2746 Graphical User Interface (GUI) (Windows Visual Basic) Graphical User Interface (GUI) (Windows Visual Basic) Graphical User Interface (GUI) (Windows MFC Visual Basic) MS Access DB Manual Entries of HCFA Forms Automatic Import (ETL from ESRD Facility Database) Automatic Export (ETL to HCFA SIMS) Form Editing, Browsing, Queries, Printing, etc. Health Care Financing Administration (HCFA) MS SQL Server RDBMS ? ETL

17. Page 17 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD Data Flow ETL #1 & 2 : VISION Import/Export of HL7 v3 XML Based HCFA Documents VISION Data Collection Tool (Windows Standalone Utility) HL7 v3 XML based HCFA -2744 HL7 v3 XML based HCFA-2728-U3 HL7 v3 XML based HCFA -2746 Graphical User Interface (GUI) (Windows Visual Basic) Graphical User Interface (GUI) (Windows Visual Basic) Graphical User Interface (GUI) (Windows MFC Visual Basic) MS Access DB Data Movement Component Meta Integration Works Data Extraction, Transformation |& Load (ETL) Generation & Maintenance of the Data Movement Components (C++ based, Windows Plug&Play) Import Export Import Export XML Files

18. Page 18 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov Health Care Financing Administration (HCFA) HCFA / ESRD Data Flow ETL #3 : HCFA / SIMS Import of HL7 v3 XML Based HCFA Documents HL7 v3 XML based HCFA -2744 HL7 v3 XML based HCFA-2728-U3 HL7 v3 XML based HCFA -2746 MS SQL Server Data Movement Component Meta Integration Works Data Extraction, Transformation |& Load (ETL) Generation & Maintenance of the Data Movement Components (C++ based, Windows Plug&Play) Import XML Files Data Movement Component Import

19. Page 19 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov End Stage Renal Disease (ESRD) Facility HCFA / ESRD Data Flow ETL #4, 5, … : ESRD Facility Export of HL7 v3 XML Based HCFA Documents HL7 v3 XML based HCFA -2744 HL7 v3 XML based HCFA-2728-U3 HL7 v3 XML based HCFA -2746 Any RDBMS via ODBC Data Movement Component Meta Integration Works Data Extraction, Transformation |& Load (ETL) Generation & Maintenance of the Data Movement Components (C++ based, Windows Plug&Play) Export XML Files Data Movement Component Export

20. Page 20 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HCFA / ESRD Data Flow Generating Data Movement Components HL7 v3 XML based HCFA Documents HL7 v3 XML based HCFA-2728-U3 MS Access DB Meta Integration Works Data Extraction, Transformation |& Load (ETL) HL7 v3 XML DTD based HCFA-2728-U3 (step 2) Model Mapper (step 1) Model Converter (Import Bridges) (step 3) Data Bridge Builder HCFA-2728 HL7 v3 XML to VISION Data Movement Component METADATA LEVEL DATA LEVEL Database Schema Logical Model (ERwin, Rose, etc.) Physical Model (DDL)

21. Page 21 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov Network #20 Network #19 … HCFA / ESRD Data Flow Introducing VISION phase 1 End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility … Network #02 Network #01 Health Care Financing Administration (HCFA) End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility Conventional Reporting HCFA (Paper) Forms VISION Data Collection Tool (Windows Standalone Utility) HCFA-2744 HCFA-2728-U3 HCFA-2746 E-Reporting HyperShip Secured Transport U.S. Postal Office Certified !

22. Page 22 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov Domain Information Models (DIM) Harmonization Process Reference Information Model (RIM) Refined Message Information Model (R-MIM) HL7 v2.x (Encoding- Rules 7) ER7 HL7 v3.x (XML DTD) Messages HL7 Development Environment The HL7 Development Environment is composed of: A repository called RIM implemented on Microsoft Access Represents the master copy of all HL7 metadata, Contains RIM tables as well as R-MIM, HMD, more? Can be populated from Rational Rose (with referential integrity, and version management)) But contains more information than in Rose? Can export to Rose A toolset called RoseTree implemented with Visual Basic Hierarchical Message Descriptions (HMD) Message Object Diagram Interaction Model Message Object Diagram Interaction Model Unused?

23. Page 23 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HL7 v3 XML Based HCFA Documents Document/Message Construction Goal –Build HL7 XML documents/messages for HCFA forms –Use Message Development Framework Version 3.2 April 1999 –Use RoseTree –RIM095 with no modifications –Use standard coding schemes LOINC codes (Logical Observation Identifiers, Names and Codes ) for identifying laboratory and clinical observations. ICD-9 (International Classification of Diseases ) –Fortunate that USAM 2.4 (Unified Service Action Model) existed

24. Page 24 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HL7 v3 XML Based HCFA Documents Current Message Choices What about the current documents –Patient Record Architecture Framework Not enough RIM information Not all the information seems to be in the RIM (i.e.,Clinical_Document_Header with Patient relationship) Closest to what we need but timeliness is an issue –Could not find other documents dealing with documents

25. Page 25 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HL7 v3 XML Based HCFA Documents Classes Used Clinical_document(1) Clinical_document_header(1) Authentication(0..1) Healthcare_document_authenticator(1) Person(1..n) Person_name(1) Service(0..n) Target(0..n) Material(1) Master_patient_service_location(1) Dependent_Service(1..n) Service(1) Healthcare_provider_organization(1) Master_patient_service_location(1) Patient(1) Person(1) Person_name(1) Employee(0..n) Person_Employment(0..n) Administrative_patient_death(1) Master_patient_service_location (from previous box) Patient(1) … Patient_Encounter(0..n) Service(0..n) Target(0..n) Material(0..1) Master_patient_service_location(0..1) Dependent_Service(0..n) Service(1..n) Consent(1) Consent.Actor(1) Consent.Witness(0..1) Master_healthcare_benefit_product(0..1) Insurer(0..1) Organization(1) Material(0..n) (Statistical) Target(0..n) Service(0..n) (statistical) Service is an Observation, Procedure, Condition_node, Medication, or Supply

26. Page 26 Implementing HCFAs ESRD E-Reporting with HL7 v3 XML Cleveland, May 22-26, 2000 © 1997-2000 Meta Integration Technology, Inc. www.metaintegration.com www.hcfa.gov HL7 v3 XML Based HCFA Documents Status Lessons learned –The RIM is fairly complete – found no needs create new relationships or to create new attributes –It is sometimes hard to choose a path when several paths are possible and valid (Services for example) –Yes/No questions require interpretation –Members of HL7 are very cooperative Waiting on –Statistics – not yet defined Used Xeena tool from IBM (free validating XML editing tool)