Submitting a HCIA Operations DUA Request
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1 Submitting a HCIA Operations DUA Request Molly Emerick, MPH Technical Advisor
2 Overview Describe the request process Provide a detailed review of the required materials for an Operations DUA request Discuss each request document and tips for completion Provide resources 2
3 Overview of Request Process Researcher ResDAC CMS GDIT Draft Packet CMMI PO identifies as Operations Packet Revisions Reviews Final Packet CMS Analyst Privacy Board Decision Notification Processing/ Onboarding Process may take 8-12 weeks 3
4 ResDAC CMMI Request Center 4
5 Request Materials & Tips for Completion 5
6 Request Materials List Request Document Notes 1. Request Letter ResDAC has created a template 2. Data Use Agreement Please complete the 6-page DUA. 3. DUA Attachment B Acknowledgement that requestor is allowed to identify physicians. 4. Signature Addendum Form Used to add additional people to the DUA. 5. Evidence of Funding Include the CMS grant award face sheet as evidence that this request is an CMMI awardee and therefore, data are free of charge. 6
7 Request Materials List, continued Request Document 6. Information Only No Fee Cost Invoice 7. CMMI Specifications Worksheet Notes ResDAC will produce an information only, no fee cost invoice so that all individuals involved with the request know that there is no charge for the data and why. This document outlines the data that are requested and where data are to be shipped. General Justification tab required 8. HIPAA Attestation Document that requests the researcher identify whether the request is being submitted as a Research or Health Care Operations request. Other file specific materials Examples include: Variable justifications for Part D and Assessment data and Part D DUA Attachment A 7
8 1. Request Letter 8
9 4. Data Use Agreement CMS will assign after submission This should be the Awardee Organization Name 9
10 Data Use Agreement Include the name of the project. Insert a CMS contract No if you have received one. Most requests will not have one. 10
11 Data Use Agreement List specific files and years requested. Leave SOR blank. Year for the crosswalk files should be the year that it was provided. (i.e. 2015) CMS has an automatic 1 yr retention period. 11
12 Data Use Agreement If signature addenda are needed, include under #12 as well as Attachment A and/or B. 12
13 Data Use Agreement #16 is the individual that is authorized to sign on behalf of the Requesting Organization. Must include physical address (No PO Boxes). #17 is the individual that is responsible for the data security. 13
14 Data Use Agreement CMMI PO will sign #20 after final package is submitted to CMS. 14
15 4a DUA Attachment B Person that signed #16 of DUA should sign here. 15
16 5. Signature Addendum to the DUA Insert study name as it appears on the DUA. Please select custodian. Must be physical signature. Must include physical address. 16
17 6. Evidence of Funding 17
18 7. Information Only No Fee Cost Invoice ResDAC will supply to the requestor 18
19 8. Specification Worksheet General Justification 19
20 8. Specifications Worksheet Data Request Details 20
21 8. Specifications Worksheet Contact Information This should be the individual that is knowledgeable about the request. This should be the individual that signed #16 of the DUA. 21
22 10. HIPAA Attestation 22
23 Request Materials List, continued Request Document File Specific Materials 11. Part D Variable Justification Notes Please provide the Part D variable justification worksheet that is found within the specifications worksheet. 12. DUA Part D Attachment A If requesting Part D data, requestor should sign the Part D Attachment A 13. Assessment Variable Justification The Assessment variable justification worksheets are separate Excel spreadsheets found on our website. 23
24 File Specific Materials 11. Part D variable justification worksheet Select the variable, provide reason for selection, & risk level. 24
25 File Specific Materials 12. Part D Attachment A 25
26 File Specific Materials 13. Assessment variable justification worksheet Select the variable, provide reason for selection. 26
27 Resources Templates are available on the website Tips documents are available for several of the request documents. It provides an explanation of what is needed for each document and question. 27
28 What Next? Prepare a draft (no signatures) to resdac@umn.edu and request a review ResDAC staff will guide you through the review process. 28
29 Healthcare Operations Request Process Step 1 Awardee and CMS Project officer designate request as Healthcare Operations Step 2 Requestor obtains materials from ResDAC CMMI website Requestor s drafts to resdac@umn.edu Step 3 ResDAC reviews and provides comments/corrections Step 4 Requestor revises all, obtains necessary signatures, and returns finals to ResDAC Step 5 ResDAC forwards finals to CMS Step 6 CMS Privacy Board reviews Privacy analyst sends decision notification to Eric Hanson and Gino Sisti; Eric or Gino sends to CMMI PO, requestor, and GDIT Step 7 GDIT processes data request and prepares physical shipment or onboarding to VRDC 29
30 Summary Request materials will be on ResDAC website Templates, tips documents, and webinars available on ResDAC website ResDAC staff are available by phone and to answer any questions you have when completing the materials Phone: Web: 30
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