Overview of Requesting CMS Data for HCIA Awardees Faith M Asper, - - PowerPoint PPT Presentation

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Overview of Requesting CMS Data for HCIA Awardees Faith M Asper, - - PowerPoint PPT Presentation

Dec 06, 2023 194 likes •369 views

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

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SLIDE 1

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

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SLIDE 2

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

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SLIDE 3

Overview of Request Process

3

HCIA A Awardee ee ResDAC CMS GDIT Draft Packet Revised Packet Review Final Packet CMS Analyst Privacy Board

(Research only)

Decision Notification DMP Review

(Research only)

Processing/ Onboarding

Work performed under CMS Contract #HHSM-500-2013-00166C

Process may take 8-12 weeks

Determine project research

  • r Ops
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SLIDE 4

Request Process

4

Work performed under CMS Contract #HHSM-500-2013-00166C

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

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SLIDE 5

Request Materials

5

Work performed under CMS Contract #HHSM-500-2013-00166C

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SLIDE 6

Request Materials

6

Work performed under CMS Contract #HHSM-500-2013-00166C

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SLIDE 7

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

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SLIDE 8

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

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SLIDE 9

Request Materials List

Requ quest est Docume ument nt Not

  • tes

es

  • 1. Request Letter

ResDAC has created a template

  • 2. Executive Summary

a. Physical receipt b. VRDC RESEARCH REQUESTS ONLY: The Executive Summary is the main document reviewed by the 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

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SLIDE 10

Request Materials List, continued

Requ quest est Docume ument nt Not

  • tes

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

Worksheet This document outlines the data that are requested.

  • 11. HCIA-HIPAA Attestation

Form This document, signed by the HCIA Awardee, acknowledges the selection to submit the request as ‘Research’ or ‘Healthcare Operations’ 10

Work performed under CMS Contract #HHSM-500-2013-00166C

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SLIDE 11

Request Materials List, continued

Requ quest est Docume ument nt Not

  • tes

es

File Specific fic Material rials

  • 12. Part D Variable

Justification Each Part D variable must be selected and justified. This is found within the HCIA specifications worksheet.

  • 13. Assessment Variable

Justification Each Assessment variable must be selected and justified. These are separate Excel spreadsheets found on our website. Other er

  • 14. Information Only - No Fee

Cost Invoice ResDAC will produce an information only, no fee cost invoice so 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

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SLIDE 12

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

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SLIDE 13

Making Changes to An Approved DUA

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Type e of Change nge ResDAC Directl ctly to 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

Work performed under CMS Contract #HHSM-500-2013-00166C

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SLIDE 14

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)

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Work performed under CMS Contract #HHSM-500-2013-00166C

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SLIDE 15

Questions

15

Work performed under CMS Contract #HHSM-500-2013-00166C