Data Request Documentation

1. ResDAC Data Request Document Checklist & Review Memo
   
   The checklist may be used by the researcher to ensure that all documentation has been completed, prior to emailing to ResDAC for review. Email checklist with documentation to be reviewed. The Review Memo will be supplied to the researcher after the ResDAC review is complete. The Review Memo must be included with the CMS data request packet.
   
   
   
2. Sample Written Request Letter
   
   The Sample Written Request Letter, submitted on organizational letterhead, outlines the primary purpose(s) for which the data are required. The Written Request Letter should contain the following elements:
   
   
   • The purpose for which the data are needed
   • A brief description of the methodology in which the data will be used
   • Criteria for data selection or searches.
   
   
   
3. Executive Summary Format
   
   The Executive Summary is a document that summarizes the objectives, provides the details of the data management plan, and lists the key personnel of the study being proposed.
   
   
4. Study Plan or Protocol Format
   
   The Study protocol is a 10-12 page document that delineates the objective, background, methods, and importance of the study being proposed. CMS will evaluate the purpose for which the data will be used to determine whether:
   
   
   • The purpose requires individually identifiable records
   • The project is of sufficient importance to warrant effect, or risk, on beneficiary privacy
   • There is reasonable probability that use of data will accomplish purpose, i.e., project is soundly designed and properly financed.

   Attention: Researchers that are federally funded may submit their approved grant proposal in lieu of the study plan/protocol discussed above.
   
   

5. Data Use Agreement (DUA)
   
   The DUA delineates the confidentiality requirements of the Privacy Act and CMS's data release policies and procedures. This agreement specifies that the requester will:
   
   
   • Ensure the data will be used only for the specific purpose stated in the agreement
   • Develop and implement the appropriate procedural, technical, and physical safeguards to prevent unauthorized use
   • Not release any files without prior CMS approval
   • Return or destroy file(s) by the date specified
   • Not publish or release information that would permit the identification of a beneficiary (i.e. suppress cell sizes less than 11).

   Signature Addendum: If anyone besides the requester or custodian is going to handle CMS data, a signature addendum may be required. View examples of when the addendum is required, for the signature addendum form, and for instructions on how to incorporate it into the DUA.

   
   
6. Internal Review Board (IRB) Documentation of Waiver Approval
   
   

   IRB documentation is required by the CMS Privacy Board.

   
   

7. Evidence of Funding
   
   CMS requires documentation that the project has been adequately financed to allow for its completion. Evidence of funding is usually a copy of the face sheet of the grant, contract, or cooperative agreement. CMS is required to obtain compensation for its costs incurred in the processing of data, and costs will vary depending on the extract methodology. Payment is made to CMS after the data request is approved.
   
   
   
8. Specification Worksheet

   The Specification Worksheet contains requester information, shipping information, method of payment, and study/project data extract details. Depending upon the type of data extract to be performed, one or several forms will need to be filled out. Note, all requesters will need to complete the 'contact and request' cover page. The cover page and individual Forms are found as individual worksheets within the MS Excel document.
   
   
   

9. Privacy Board Review Summary Sheet
   
   

   The CMS Privacy Review Board uses this document as a permanent record of the Privacy Board review.
   
   
   

10. Formal CMS Cost Estimate
    
    To assist ResDAC staff in submitting a cost estimate request to CMS, please fill in the requested information and e-mail it to ResDAC.
    
    
    
11. Sample Letter of Support from Federal Project Officer (federally funded projects only)
    
    The Sample Letter of Support from Federal Project Officer is only applicable for those researchers whose project is funded by a federal granting institution. The Project Officer will also be required to sign the DUA.
    
    
    
12. Additional documentation needed for Assessment data
    
    
13. Additional documentation needed for Name & Address File request
    
    

After ResDAC review, CMS data request packets should be mailed to:

Maribel Franey, Division Director
Division of Privacy Compliance Data Development (DPC)
Centers for Medicare & Medicaid Services (CMS)
OIS/EASG/DPC N2-04-27
7500 Security Blvd.
Baltimore, Maryland 21244-1850