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End Stage Renal Disease (ESRD) http://www.hcfa.gov/medicare/esrdpage.htm http://www.hcfa.gov/quality/qlty%2D5d.htm

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

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End Stage Renal Disease (ESRD) http://www.hcfa.gov/medicare/esrdpage.htm http://www.hcfa.gov/quality/qlty%2D5d.htm

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  1. 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 Systemto Improve Outcomes in Nephrology (VISION)HCFA / ESRD E-Reporting based on HL7 v3 XML Technology XML based Data Collection / ETL Toolsoonhttp://www.metaintegration.net/HCFA Contacts @ HCFAContacts @ Meta Integration Cyrus Karimian CKarimian@hcfa.gov Bill Le Clair leclair@metaintegration.com Denis Stricker DStricker@hcfa.gov Christian Bremeau bremeau@metaintegration.com

  2. HCFA ESRD Network SOWBackground • 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. HCFA ESRD Network SOWGoals • 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. HCFA ESRD Network SOWInformation Management • The Network shall be required to utilize theStandard 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. HCFA / ESRD / SIMSResponsibilities • 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. 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. HCFA / ESRD / SIMSDatabase 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. HCFA / ESRD / SIMSCollection, 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. HCFA / ESRD / SIMSCollection, 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. HCFA / ESRD / SIMSCollection, 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. HCFA / ESRD Data FlowThe big picture… Social SecurityAdministration(SSA) End Stage Renal Disease (ESRD) Facility Transforming the ESRD Reporting Process to HCFAfrom Paper Forms to HL7 v3 XML based E-reporting End Stage Renal Disease (ESRD) Facility Health CareFinancingAdministration(HCFA) End Stage Renal Disease (ESRD) Facility ESRD Medical Evidence ReportMedicare Entitlement And/Or Patient RegistrationForm HCFA-2728-U3 ESRD Medical Information SystemFacility SurveyPart One: DialysisPart Two: Kidney Transplants Form HCFA-2744 FacilitySpecific InformationForm SIMS-??? PatientSpecific InformationForm SIMS-??? In-Center Hemodialysis (HD)Clinical Performance Measures Data CollectionForm 2000, Form HCFA-820 Patient DeathForm HCFA-2746 Peritoneal Dialysis (PD)Clinical Performance Measures Data CollectionForm 2000 Form HCFA-821 ESRD Beneficiary Selection(Home Patients Only)Form HCFA-382 Dialysis Facility (DF)Clinical Performance Measures Data CollectionForm 2000 Form HCFA-???

  12. HCFA / ESRD Data FlowThe SIMS front end End Stage Renal Disease (ESRD) Facility SIMS Networks(geographicallydistributed) End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility Network #01 SIMS Health Care Financing Administration (HCFA) Network #02 End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility SIMS End Stage Renal Disease (ESRD) Facility ReportingHCFA(Paper)Forms Integrated SIMS Repository (Master) … … HCFA Internal Databases Network #20 End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility SIMS End Stage Renal Disease (ESRD) Facility Integrated SIMS Repository (Shadow) HCFA-2728-U3 HCFA-2746 HCFA-2744 OvernightUpdates Replication IBM Model 2.04 Databases MS SQL Server Databases

  13. HCFA / ESRD Data FlowInside HCFA Today… Social SecurityAdministration(SSA) Health Care Financing Administration (HCFA) MS SQLServer Integrated SIMS Repository (Master) IBM Model 2.04 REBUS “Renal Beneficiary and Utilization System” Integrated SIMS Repository (Shadow) IBM Model 2.04 HCFA Main Database

  14. HCFA / ESRD Data FlowInside HCFA Tomorrow… Health Care Financing Administration (HCFA) Oracle Business Intelligence (BI) &Knowledge Management (KM) Solutions: Data Warehousing Data Mining OLAP AuxiliaryESRD 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). Oracle 8i Updates ETL Legacy Migration ETL IBM Model 2.04 Oracle 8i Legacy ESRD Database: REBUS “Renal Beneficiary and Utilization System” (to be shutdown) New ESRD Database: REMIS "Renal Management Information System" Updates ETL IBM Model 2.04 HCFA Main Database

  15. HCFA / ESRD Data FlowLong Term Objective… Do they havea database ? Health CareFinancingAdministration(HCFA) End Stage Renal Disease (ESRD) Facility MS SQL Server Data Extraction, Transformation & Load (ETL) Electronic Data Interchange (EDI)over Secure Internet (based on XML) RDBMS ? SIMS Home Made or Commercial Product Are they connectedon internet / dialups ? Is HL7 v3XML Ready ? How about the securityof the medical information ?

  16. HCFA / ESRD Data FlowThe VISION Data Collection Tool(Vital Information System to Improve Outcomes in Nephrology) • Manual Entries of HCFA Forms • Automatic Import (ETL from ESRD Facility Database) • Automatic Export (ETL to HCFA SIMS) • Form Editing, Browsing, Queries, Printing, etc. HCFA-2728-U3 HCFA-2746 HCFA-2744 VISION Data Collection Tool(Windows Standalone Utility) End Stage Renal Disease (ESRD) Facility Health CareFinancingAdministration(HCFA) Graphical User Interface (GUI)(Windows Visual Basic) Graphical User Interface (GUI)(Windows Visual Basic) Graphical User Interface (GUI)(Windows MFC Visual Basic) MS SQL Server MS Access DB RDBMS ? SIMS ETL ETL VISION (similar to SIMS) Home Made or Commercial Product

  17. HCFA / ESRD Data FlowETL #1 & 2 : VISION Import/Export of HL7 v3 XML “Based” HCFA Documents VISION Data Collection Tool(Windows Standalone Utility) Meta Integration Works Data Extraction,Transformation|& Load (ETL) Graphical User Interface (GUI)(Windows Visual Basic) Graphical User Interface (GUI)(Windows Visual Basic) Graphical User Interface (GUI)(Windows MFC Visual Basic) Generation & Maintenance of theData Movement Components(C++ based, Windows Plug&Play) XML Files MS Access DB Import Data Movement Component HL7 v3 XML basedHCFA-2728-U3 Export Data Movement Component VISION (similar to SIMS) Import Data Movement Component HL7 v3 XML basedHCFA -2744 Export HL7 v3 XML basedHCFA -2746

  18. HCFA / ESRD Data FlowETL #3 : HCFA / SIMS Import of HL7 v3 XML “Based” HCFA Documents Meta Integration Works Data Extraction,Transformation|& Load (ETL) Health CareFinancingAdministration(HCFA) Generation & Maintenance of theData Movement Components(C++ based, Windows Plug&Play) XML Files MS SQLServer HL7 v3 XML basedHCFA-2728-U3 Import Data Movement Component SIMS Import Data Movement Component HL7 v3 XML basedHCFA -2744 Import HL7 v3 XML basedHCFA -2746

  19. HCFA / ESRD Data FlowETL #4, 5, … : ESRD Facility Export of HL7 v3 XML “Based” HCFA Documents Meta Integration Works Data Extraction,Transformation|& Load (ETL) Generation & Maintenance of theData Movement Components(C++ based, Windows Plug&Play) End Stage Renal Disease (ESRD) Facility XML Files Any RDBMSvia ODBC HL7 v3 XML basedHCFA-2728-U3 Export Home Made or Commercial Product Data Movement Component Export Data Movement Component HL7 v3 XML basedHCFA -2744 Export HL7 v3 XML basedHCFA -2746

  20. HCFA / ESRD Data FlowGenerating Data Movement Components HL7 v3 XML “based” HCFA Documents Meta Integration Works Data Extraction,Transformation|& Load (ETL) (step 1) Model Converter (Import Bridges) Database SchemaLogical Model (ERwin, Rose, etc.)Physical Model (DDL) METADATALEVEL HL7 v3 XML DTDbasedHCFA-2728-U3 (step 2) Model Mapper (step 3) Data Bridge Builder MS Access DB VISION (similar to SIMS) HL7 v3 XMLbased HCFA-2728-U3 HCFA-2728 HL7 v3 XML to VISION Data Movement Component DATALEVEL

  21. HCFA / ESRD Data FlowIntroducing VISION phase 1 End Stage Renal Disease (ESRD) Facility Health Care Financing Administration (HCFA) End Stage Renal Disease (ESRD) Facility Network #01 End Stage Renal Disease (ESRD) Facility SIMS Network #02 End Stage Renal Disease (ESRD) Facility SIMS End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility ConventionalReporting HCFA(Paper)Forms Integrated SIMS Repository (Master) … … Network #19 End Stage Renal Disease (ESRD) Facility SIMS End Stage Renal Disease (ESRD) Facility End Stage Renal Disease (ESRD) Facility Integrated SIMS Repository (Shadow) VISIONData CollectionTool(WindowsStandaloneUtility) Network #20 E-Reporting “HyperShip”SecuredTransport U.S. PostalOfficeCertified ! SIMS HCFA-2728-U3 HCFA-2746 HCFA-2744

  22. HL7 DevelopmentEnvironment Interaction Model Interaction Model Interaction Model Unused? DomainInformation Models(DIM) ReferenceInformation Model(RIM) Refined Message Information Model(R-MIM) Message Object Diagram Message Object Diagram Message Object Diagram Harmonization Process HierarchicalMessageDescriptions(HMD) • 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 HL7 v2.x(Encoding- Rules 7) ER7 HL7 v3.x(XML DTD)Messages

  23. HL7 v3 XML “Based” HCFA DocumentsDocument/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. 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. 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. 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)

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