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 Introduction to Requesting CMS Using CMS Data CMS Data Data - Strengths and - Cost estimates - Variable and weakness of for CMS data code value CMS data definitions - Questions about - Data file request process - Program policies availability that affect data - Formal contents - Cohort selection applications for CMS identifiable - Claims data processing that affect data contents ResDAC Support 3
Overview of Request Process Researcher ResDAC DPSP CMS Buccaneer Contractor Draft DMP Review Packet Packet Reviews Revisions Final Packet CMS Analyst Privacy Board Decision Payment Notification Confirmation Processing 4
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 obtains 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 of 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 on 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
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