submitting an hcia operations dua requestresdac.umn.edu/sites/resdac.umn.edu/files/submitting an...

Submitting a HCIA Operations DUA Request

Molly Emerick, MPH

Technical Advisor

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

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

Overview of Request Process

3

Researcher ResDAC CMS GDIT

Draft

Packet

Packet

Revisions Reviews

Final Packet CMS Analyst

Privacy

Board

Decision

Notification

Processing/

Onboarding

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

Process may take 8-12 weeks

CMMI PO

identifies as

Operations

ResDAC CMMI Request Center

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

Request Materials & Tips for Completion

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

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

Request Materials List, continued

Request Document Notes

6. 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

there is no charge for the data and why.

7. CMMI Specifications

Worksheet

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

1. Request Letter

8

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

4. Data Use Agreement

9

CMS will

assign after

submission

This should

be the

Awardee

Organization

Name

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

Data Use Agreement

10

Insert a CMS contract No

if you have received one.

Most requests will not

have one.

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

Include the name of the

project.

Data Use Agreement

11

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.

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

Data Use Agreement

12

If signature addenda

are needed, include

under #12 as well as

Attachment A and/or

B.

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

Data Use Agreement

13

#16 is the individual

that is authorized to

sign on behalf of the

Requesting

Organization.

#17 is the individual

that is responsible for

the data security.

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

Must include

physical address

(No PO Boxes).

Data Use Agreement

14

CMMI PO will sign #20 after final package is submitted to CMS.

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

4a – DUA Attachment B

15

Person that signed #16 of DUA should sign here.

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

5. Signature Addendum to the DUA

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

Insert study name

as it appears on

the DUA.

Please select

custodian.

Must include

physical address. Must be physical

signature.

6. Evidence of Funding

17

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

7. Information Only No Fee Cost Invoice

18

ResDAC will supply to the requestor

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

8. Specification Worksheet

19

General Justification

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

8. Specifications Worksheet

Data Request Details

20

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

8. Specifications Worksheet

Contact Information

21

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

This should be the

individual that is

knowledgeable

about the request.

This should be the

individual that

signed #16 of the

DUA.

10. HIPAA Attestation

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

Request Materials List, continued

Request Document Notes

File Specific Materials

11. Part D Variable

Justification

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

File Specific Materials 11. Part D variable justification worksheet

24

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

Select the

variable, provide

reason for

selection, & risk

level.

File Specific Materials 12. Part D Attachment A

25

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

File Specific Materials 13. Assessment variable justification worksheet

26

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

Select the

variable, provide

reason for

selection.

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

What Next?

Prepare a draft (no signatures)

Email to resdac@umn.edu and request a review

ResDAC staff will guide you through the review

process.

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

Healthcare Operations Request Process

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

Step 1 •Awardee and CMS Project officer designate request as Healthcare Operations

Step 2

•Requestor obtains materials from ResDAC CMMI website

•Requestor emails 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

Summary

Request materials will be on ResDAC website

Templates, tips documents, and webinars

available on ResDAC website

ResDAC staff are available by phone and email to

answer any questions you have when completing

the materials

˗ Email: resdac@umn.edu

˗ Phone: 1-888-973-7322

˗ Web: http://www.resdac.org

30

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