Form Cms-R-0235l - Agreement For Use Of Centers For Medicare & Medicaid Services (Cms) Limited Data Sets

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES
INSTRUCTIONS FOR COMPLETING THE LIMITED DATA SET
DATA USE AGREEMENT (DUA) (CMS-R-0235L)
This Agreement is needed to ensure that the disclosure and use of Limited Data Sets derived from a CMS
Privacy Act System of Records comply with the Privacy Act of 1974 (5 U.S.C. § 522a) and the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (45 C.F.R Parts 160 and 164).
Directions for the completion of the agreement follow:
Before completing the DUA, please note the language contained in this agreement cannot be altered in
any form.
A. First paragraph, enter the Requestor’s/User’s Organization Name.
B. Section #1, enter the Requestor’s/User’s Organization Name.
C. Section #3, enter the study and/or project name and CMS contract number, if applicable, for which the
file(s) will be used. Include both a summary of the purpose and a detailed explanation of the research
study or project. The detailed explanation describing your research purpose must be attached to the
agreement. Attached to this Agreement are the Research Application Guidelines that should be followed
in preparing your detailed explanation. CMS evaluates the purpose for which the limited data set file
will be used to determine whether: 1) the purpose requires identifiable records; 2) the project is of
sufficient importance to justify the risk on beneficiary privacy; 3) there is reasonable probability that the
use of data will accomplish the purpose, i.e., the project is soundly designed; and 4) the purpose
demonstrates the potential to improve the quality of life for Medicare beneficiaries or improve the
administration of the Medicare program, including payment related projects. If the Research Application
provided by the Requesting Organization contains proprietary information, a statement to that effect
must be included in the Research Application submitted to CMS. Proprietary information is exempt
from release under the Freedom of Information Act if it falls within the scope of Exemption 4, 5 U.S.C.
§ 552(b)(4).
D. Section #4 should delineate the limited data set files and years of data the Requestor/User is requesting.
Specific filenames should be specified. If these filenames are unknown, you may contact a CMS
representative.
E. Section #6, complete by entering the projected completion date of the study or project.
F. Section #14 is to be completed by the Requestor/User.
G. Section #15, enter the Custodian Name, Company/Organization, Address, Phone Number (including
area code), and E-Mail Address (if applicable). The Custodian of the files (name and position/title) is
defined as the person who will have actual possession of and responsibility for the limited data set files.
This section should be completed even if the Custodian and Requestor/User are the same.
H. Section #16 will be completed by a CMS representative.
I. Section #17 will be completed by a CMS representative.
For assistance or questions in completing this Agreement, please contact the Division of Privacy Compliance
Help Line at 410-786-3690.
Form CMS-R-0235L (02/08)
1

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