Making Changes to Your CMS Approved Study : Amendment Requests - - PowerPoint PPT Presentation

Making Changes to Your CMS Approved Study : Amendment Requests

Presented by Sarah Brunsberg, ResDAC Technical Advisor

About ResDAC

• Centers for Medicare and Medicaid (CMS)

contractor.

• Offer free assistance to researchers interested in

using Medicare and Medicaid data for research.

• Staffed by a team of public health and health

services research specialists.

• Provide a range of CMS data related services,

including assistance with the Research Identifiable data request process.

2

ResDAC Services

3

Introduction to CMS Data Requesting CMS Data Using CMS Data

• Strengths and

weakness of CMS data

• Data file

availability

• Cohort selection
• Cost estimates

for CMS data

• Questions about

request process

• Formal

applications for CMS identifiable data

• Variable and

code value definitions

• Program policies

that affect data contents

• Claims

processing that affect data contents

ResDAC Support

Overview of Request Process

4

Researcher ResDAC DPSP Contractor CMS Buccaneer Draft Packet Packet Revisions Reviews Final Packet CMS Analyst Privacy Board Decision Notification Payment Confirmation DMP Review Processing

Types of Requests Overview

• New Study Request

˗ Includes new use and reuse requests ˗ Researchers submit a new study request if they need data for a new study or want to use data that they already have for a new study

• Amendment Request

˗ There are numerous types of amendment requests ˗ Researcher submit amendment requests if they want to change something on their DUA regarding a current study, not for a new study

5

Research Identifiable Data File Amendment Request Types

• Adding new years of data files previously covered

under DUA

• Adding new years of data files not previously

covered under the DUA

• Making a change to your approved data

management plan

• Adding new study personnel to your DUA

6

Adding Years of Data Previously Covered Under DUA

• Involves adding new years of data that are already

covered under DUA

• Necessary Request Documents:

˗ Written request letter ˗ Update DUA ˗ Specification Worksheet ˗ Cost Estimate ˗ Letter of continuing support from federal project officer

» If original study protocol did not state that you planned to request future years of data, you will need to include this support letter

7

Adding New Years of Data not Previously Covered Under DUA

• Involves adding data to your DUA that you have not

previously requested from CMS

• Necessary Request Documents:

˗ Written Request letter ˗ Update DUA (if requesting Part D for the first time, must use a full DUA and not an update DUA form) ˗ Specification Worksheet ˗ Cost Estimate ˗ Executive Summary ˗ Letter of Support from Federal Project Officer

8

Making a Change to the Data Management Plan

• Must inform CMS of any time you make a change to the

data management plan

• Includes scenarios such as:

˗ Moving a copy of the data ˗ Making data security changes

• Necessary Request Documents

˗ Written request letter ˗ Data Management plan that incorporates changes

» leave rest of the executive summary document blank

˗ Signature Addenda if adding new study personnel to DUA *Note: If moving physical copy of data to another organization (ex: PI

• btains new appointment at another University), the new organization

will need to submit their own data management plan

9

Adding/Removing Study Personnel

• If you need to make changes to the personnel that will

access CMS data files, you will need to submit an amendment request.

• You can submit this amendment request directly to CMS

for review and processing: datauseagreement@cms.hhs.gov

˗ ResDAC does not need to review these requests

• Request documents:

˗ Email directly to CMS following instructions on the DUA – Contact Changes page

» Email must be from someone currently listed on the DUA » www.cms.gov (click on research, statistics, data and systems, and click on the privacy link under computer data & systems)

˗ Signed signature addendum for the new study personnel

10

Submitting an Amendment Request to ResDAC

• Download required documents from the ResDAC

website: http://www.resdac.org/cms- data/request/research-identifiable-files

˗ Note: Please pull fresh copies of documents from the website each time you submit an amendment request as the documents do change

• Complete materials and email dr

draf aft t ver ersions sions (unsigned) to resdac@umn.edu

• Your request will be assigned to a Technical

Advisor who will be in touch within 7-10 business days

11

A Few Things to Remember

• CMS does not allow researchers to request years
• f data that are not yet available. When data files

become available, researchers can submit an amendment request to their existing DUA to get new years

• If you are ever unsure as to what type of

amendment request you should submit, contact ResDAC to discuss

12

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 (not all will apply) »Tips for Completing the DUA and Signature Addendum (not all will apply)

13

Upcoming Webinars

• Please visit the website for information about

upcoming webinars

• We will post the slides and audio for this Webinar
• n the ResDAC website

14

Questions?

• Please submit questions via the “Q&A”

feature

• Want to contact us offline?

ResDAC Assistance Desk

˗ Email: resdac@umn.edu ˗ Phone: 1-888-973-7322 ˗ Web: http://www.resdac.org

15