Overview of Requesting CMS Data for HCIA Awardees Faith M Asper, M.H.S., CIPP/G Director of ResDAC Assistance Desk Work performed under CMS Contract #HHSM-500-2013-00166C
Overview Overview of the identifiable request timelines and process Review of the required materials ˗ CMS Research Identifiable Request Materials ˗ CMS Healthcare Operations Request Materials Tips for obtaining data more quickly Overview of making changes to an approved Data Use Agreement 2 Work performed under CMS Contract #HHSM-500-2013-00166C
Overview of Request Process HCIA A Awardee ee ResDAC CMS GDIT Determine project research or Ops Draft DMP Review Review Packet (Research only) Revised Final Packet CMS Analyst Packet Privacy Board (Research only) Decision Processing/ Notification Onboarding Process may take 8-12 weeks 3 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Process Step 1 • Identify request as research or operations Step 2 • Draft submission of materials and initial review process Step 3 • Final packet submission (Awardee >> ResDAC >> CMS) Step 4 • RESEARCH DUA ONLY: CMS Privacy Board review Step 5 • CMS Decision Notification (HCIA Staff >> Awardee & GDIT) Step 6 • GDIT prepares physical shipment or onboarding to VRDC 4 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials 5 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials 6 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List Requ quest est Docume ument nt HC Operat ation ions Resea earch ch 1. Request Letter * * 2. Executive Summary * 3. Study Protocol * 4. Data Use Agreement (DUA) * * 5. DUA Attachment A * * 6. DUA Attachment B * * 7. Signature Addendum to DUA * * 8. IRB Waiver Approval * 9. Evidence of Funding * * 10. HCIA Specifications Worksheet * * 11. HCIA-HIPAA Attestation Form * * 7 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List – File specific Requ quest est Docume ument nt HC Operat ation ions Resea earch ch File Specific fic Material rials 12. Part D Variable Justification Worksheet * * 13. Assessment (MDS, OASIS, IRF-PAI, Swing-bed) * * Variable Justification Worksheet 8 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List Requ quest est Docume ument nt Not otes es 1. Request Letter ResDAC has created a template 2. Executive Summary RESEARCH REQUESTS ONLY: a. Physical receipt The Executive Summary is the main document reviewed by the b. VRDC CMS Privacy Board. It includes a Data management plan, which is reviewed by GDIT. 3. Study Protocol RESEARCH REQUESTS ONLY: Please supply the CMMI grant or proposal that CMS approved. 4. Data Use Agreement Please complete the 6-page DUA. CMS Project officer signature will be secured after final materials are sent to CMS. 5. DUA – Attachment A Attachment A overrides the DUA language and specifics additional terms of use for HCIA Awardees related to Part D data and use of personally identifiable beneficiary information. 6. DUA Attachment B Attachment B is an acknowledgement that it is acceptable to identify physicians and produce reports at the physician level. 9 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List, continued Requ quest est Docume ument nt Not otes es 7. Signature Addendum to DUA This is needed for individuals that will access the data and do NOT report to either the User (#16 of DUA) or Custodian (#17 of DUA). This may also be needed if the VRDC seat holders did not sign #16 or #17. 8. IRB Waiver Approval RESEARCH REQUESTS ONLY: Institutional review board waiver approval is necessary for all research requests. 9. Evidence of Funding Include the CMS grant award face sheet as evidence that this request is an HCIA Awardee and therefore, data are free of charge. 10. HCIA Specifications This document outlines the data that are requested. Worksheet 11. HCIA-HIPAA Attestation This document, signed by the HCIA Awardee, acknowledges the Form selection to submit the request as ‘Research’ or ‘Healthcare Operations’ 10 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List, continued Requ quest est Docume ument nt Not otes es File Specific fic Material rials 12. Part D Variable Each Part D variable must be selected and justified. This is Justification found within the HCIA specifications worksheet. 13. Assessment Variable Each Assessment variable must be selected and justified. Justification These are separate Excel spreadsheets found on our website. Other er 14. Information Only - No Fee ResDAC will produce an information only, no fee cost invoice so Cost Invoice that all individuals involved with the request know that these data are provided at no charge to the Awardee. 11 Work performed under CMS Contract #HHSM-500-2013-00166C
Tips for Obtaining Data More Quickly Determine the data that are needed ˗ Suggest awardee talk to ResDAC about the data available and what data would be best for the study. Request minimum data necessary ˗ Awardee needs to consider project timeline and complexity of working with several different data files and benefit to the project. Provide the materials needed ˗ If awardee needs help, » Review TIPS document » Contact ResDAC 12 Work performed under CMS Contract #HHSM-500-2013-00166C
Making Changes to An Approved DUA Directl ctly to Type e of Change nge ResDAC CMS Webinar: “Making Changes to an Approved HCIA DUA” http://www.resdac.org/training/media/webcasts/making-changes-approved-hcia-dua Contact changes X Extension request X DUA Closure X Adding new years or files X Change in Data Management Plan X Change in VRDC Seat Holder X 13 Work performed under CMS Contract #HHSM-500-2013-00166C
Resources for Help ResDAC Assistance Desk ˗ Email: resdac@umn.edu ˗ Phone: 1-888-973-7322 ˗ Web: http://www.resdac.org ResDAC Website ˗ CMS Data Request Center ˗ ResConnect (Resource Library) » Tips for Completing a RIF Request Packet (Research) » Tips for Completing the DUA (Research & Healthcare Operations) 14 Work performed under CMS Contract #HHSM-500-2013-00166C
Questions 15 Work performed under CMS Contract #HHSM-500-2013-00166C
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