Form CMS-R-235 Data Use Agreement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

INSTRUCTIONS FOR COMPLETING THE DATA USE AGREEMENT (DUA) FORM CMS-R-0235
(AGREEMENT FOR USE OF CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
DATA CONTAINING INDIVIDUAL IDENTIFIERS)
This agreement must be executed prior to the disclosure of data from CMS’ Systems of Records to ensure that
the disclosure will comply with the requirements of the Privacy Act, the Privacy Rule and CMS data release
policies. It must be completed prior to the release of, or access to, specified data files containing protected
health information and individual identifiers.
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.
• First paragraph, enter the Requestor’s Organization Name.
• Section #1, enter the Requestor’s Organization Name.
• Section #4 enter the Study and/or Project Name and CMS contract number if applicable for which the
file(s) will be used.
• Section #5 should delineate the files and years the Requestor is requesting. Specific file names should be
completed. If these are unknown, you may contact a CMS representative to obtain the correct names
The System of Record (SOR) should be completed by the CMS contact or Project Officer. The SOR is
the source system the data came from.
• Section #6, complete by entering the Study/Project’s anticipated date of completion.
• Section #12 will be completed by the User.
• Section #16 is to be completed by Requestor.
• Section #17, enter the Custodian Name, Company/Organization, Address, Phone Number (including area
code), and E-Mail Address (if applicable). The Custodian of files is defined as that person who will have
actual possession of and responsibility for the data files. This section should be completed even if the
Custodian and Requestor are the same. This section will be completed by Custodian.
• Section #18 will be completed by a CMS representative.
• Section #19 should be completed if your study is funded by one or more other Federal Agencies. The
Federal Agency name (other than CMS) should be entered in the blank. The Federal Project Officer
should complete and sign the remaining portions of this section. If this does not apply, leave blank.
• Sections #20a AND 20b will be completed by a CMS representative.
• Addendum, CMS-R-0235A, should be completed when additional custodians outside the requesting
organization will be accessing CMS identifiable data.
Once the DUA is received and reviewed for privacy and policy issues, a completed and signed copy will be
sent to the Requestor and CMS Project Officer, if applicable, for their files.
Form CMS-R-0235 (03/08)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

Form Approved
OMB No. 0938-0734

DATA USE AGREEMENT
DUA #

(AGREEMENT FOR USE OF CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)
DATA CONTAINING INDIVIDUAL IDENTIFIERS)
CMS agrees to provide the User with data that reside in a CMS Privacy Act System of Records as identified in this
Agreement. In exchange, the User agrees to pay any applicable fees; the User agrees to use the data to support the User’s
study, research or project referenced in this Agreement, which has been determined by CMS to provide assistance to CMS
in monitoring, managing and improving the Medicare and Medicaid programs or the services provided to beneficiaries;
and the User agrees to ensure the integrity, security, and confidentiality of the data by complying with the terms of this
Agreement and applicable law. In order to secure data that reside in a CMS Privacy Act System of Records; in order
to ensure the integrity, security, and confidentiality of information maintained by the CMS; and to permit appropriate
disclosure and use of such data as permitted by law, CMS and _________________________________________________
(Requestor)
enter into this agreement to comply with the following specific paragraphs.
1. This Agreement is by and between the Centers for Medicare & Medicaid Services (CMS), a component of the
U.S. Department of Health and Human Services (HHS), and __________________________________________,
(Requestor)
hereinafter termed “User.”
2. This Agreement addresses the conditions under which CMS will disclose and the User will obtain, use, reuse
and disclose the CMS data file(s) specified in section 5 and/or any derivative file(s) that contain direct individual
identifiers or elements that can be used in concert with other information to identify individuals. This Agreement
supersedes any and all agreements between the parties with respect to the use of data from the files specified
in section 5 and preempts and overrides any instructions, directions, agreements, or other understanding in or
pertaining to any grant award or other prior communication from the Department of Health and Human Services
or any of its components with respect to the data specified herein. Further, the terms of this Agreement can be
changed only by a written modification to this Agreement or by the parties adopting a new agreement. The parties
agree further that instructions or interpretations issued to the User concerning this Agreement or the data specified
herein, shall not be valid unless issued in writing by the CMS point-of-contact specified in section 5 or the CMS
signatory to this Agreement shown in section 21.
3. The parties mutually agree that CMS retains all ownership rights to the data file(s) referred to in this Agreement, and that
the User does not obtain any right, title, or interest in any of the data furnished by CMS.
4. The User represents, and in furnishing the data file(s) specified in section 5 CMS relies upon such
representation, that such data file(s) will be used solely for the following purpose(s).
Name of Study/Project
CMS Contract No.

(If applicable)

The User represents further that the facts and statements made in any study or research protocol or project plan
submitted to CMS for each purpose are complete and accurate. Further, the User represents that said study
protocol(s) or project plans, that have been approved by CMS or other appropriate entity as CMS may determine,
represent the total use(s) to which the data file(s) specified in section 5 will be put.
The User agrees not to disclose, use or reuse the data covered by this agreement except as specified in an
Attachment to this Agreement or except as CMS shall authorize in writing or as otherwise required by law, sell,
rent, lease, loan, or otherwise grant access to the data covered by this Agreement. The User affirms that the
requested data is the minimum necessary to achieve the purposes stated in this section. The User agrees that,
within the User organization and the organizations of its agents, access to the data covered by this Agreement
shall be limited to the minimum amount of data and minimum number of individuals necessary to achieve the
purpose stated in this section (i.e., individual’s access to the data will be on a need-to-know basis).
Form CMS-R-0235 (03/08)

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File

Years(s)

System of Record

6. The parties mutually agree that the aforesaid file(s) (and/or any derivative file(s)) including those files that
directly identify individuals and those that can be used in concert with other information to identify individuals
may be retained by the User until, Date
hereinafter known as the “Retention Date.” The User
agrees to notify CMS within 30 days of the completion of the purpose specified in section 4 if the purpose is
completed before the aforementioned retention date. Upon such notice or retention date, whichever occurs sooner,
the User agrees to destroy such data. The User agrees to destroy and send written certification of the destruction
of the files to CMS within 30 days. The User agrees not to retain CMS files or any parts thereof, after the
aforementioned file(s) are destroyed unless the appropriate Systems Manager or the person designated in section
21 of this Agreement grants written authorization. The User acknowledges that the date is not contingent upon
action by CMS.
The Agreement may be terminated by either party at any time for any reason upon 30 days written notice. Upon
notice of termination by User, CMS will cease releasing data from the file(s) to the User under this Agreement and
will notify the User to destroy such data file(s). Sections 3, 4, 6, 9, 10, 11, 12, 14 and 15 shall survive termination
of this Agreement
7. The User agrees to establish appropriate administrative, technical, and physical safeguards to protect the
confidentiality of the data and to prevent unauthorized use or access to it. The safeguards shall provide a
level and scope of security that is not less than the level and scope of security established by the Office of
Management and Budget (OMB) in OMB Circular No. A-130, Appendix III—Security of Federal Automated
Information Systems (http://www.whitehouse.gov/omb/circulars/a130/a130.html), which sets forth guidelines
for security plans for automated information systems in Federal agencies. The User acknowledges that the
use of unsecured telecommunications, including the Internet, to transmit individually identifiable or deducible
information derived from the file(s) specified in section 5 is prohibited. Further, the User agrees that the data
must not be physically moved, transmitted or disclosed in any way from or by the site indicated in section 18
without written approval from CMS unless such movement, transmission or disclosure is required by a law.
8. The User agrees to grant access to the data to the authorized representatives of CMS or DHHS Office of the
Inspector General at the site indicated in section 4 for the purpose of inspecting to confirm compliance with the
terms of this agreement.
9. The User agrees not to disclose direct findings, listings, or information derived from the file(s) specified in section
5, with or without direct identifiers, if such findings, listings, or information can, by themselves or in combination
with other data, be used to deduce an individual’s identity. Examples of such data elements include, but are not
limited to geographic location, age if > 89, sex, diagnosis and procedure, admission/discharge date(s), or date
of death.
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 The User agrees that any use of CMS data in the creation of any document (manuscript, table, chart, study,
report, etc.) concerning the purpose specified in section 4 (regardless of whether the report or other writing
expressly refers to such purpose, to CMS, or to the files specified in section 5 or any data derived from such files)
must adhere to CMS’ current cell size suppression policy. This policy stipulates that no cell (eg. admittances,
discharges, patients) less than 11 may be displayed. Also, no use of percentages or other mathematical formulas
may be used if they result in the display of a cell less than 11. By signing this Agreement you hereby agree to
abide by these rules and, therefore, will not be required to submit any written documents for CMS review. If you
are unsure if you meet the above criteria, you may submit your written products for CMS review. CMS agrees to
make a determination about approval and to notify the user within 4 to 6 weeks after receipt of findings. CMS may
withhold approval for publication only if it determines that the format in which data are presented may result in
identification of individual beneficiaries
10. The User agrees that, absent express written authorization from the appropriate System Manager or the person
designated in section 21 of this Agreement to do so, the User shall not attempt to link records included in the
file(s) specified in section 5 to any other individually identifiable source of information. This includes attempts to
link the data to other CMS data file(s). A protocol that includes the linkage of specific files that has been approved
in accordance with section 4 constitutes express authorization from CMS to link files as described in the protocol.
11. The User understands and agrees that they may not reuse original or derivative data file(s) without prior written
approval from the appropriate System Manager or the person designated in section 21 of this Agreement.
12. The parties mutually agree that the following specified Attachments are part of this Agreement:
____________________________________________________________________________________
13. The User agrees that in the event CMS determines or has a reasonable belief that the User has made or may have
made a use, reuse or disclosure of the aforesaid file(s) that is not authorized by this Agreement or another written
authorization from the appropriate System Manager or the person designated in section 21 of this Agreement,
CMS, at its sole discretion, may require the User to: (a) promptly investigate and report to CMS the User’s
determinations regarding any alleged or actual unauthorized use, reuse or disclosure, (b) promptly resolve any problems
identified by the investigation; (c) if requested by CMS, submit a formal response to an allegation of unauthorized
use, reuse or disclosure; (d) if requested by CMS, submit a corrective action plan with steps designed to prevent
any future unauthorized uses, reuses or disclosures; and (e) if requested by CMS, return data files to CMS or
destroy the data files it received from CMS under this agreement. The User understands that as a result of CMS’s
determination or reasonable belief that unauthorized uses, reuses or disclosures have taken place, CMS may refuse
to release further CMS data to the User for a period of time to be determined by CMS.
If the User becomes aware that personally identifiable information received from CMS under this DUA may have
been lost or disclosed to any unauthorized persons, the User agrees to notify the CMS Action Desk by telephone
at (410) 786-2850 within one hour and to cooperate fully in the federal security incident process. Furthermore, if
CMS determines that the risk of harm requires notification of affected individual persons of the security breach
and/or other remedies, the User agrees to carry out these remedies without cost to CMS.

Form CMS-R-0235 (03/08)

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 14. The User hereby acknowledges that criminal penalties under §1106(a) of the Social Security Act (42 U.S.C.
§ 1306(a)), including a fine not exceeding $10,000 or imprisonment not exceeding 5 years, or both, may apply to
disclosures of information that are covered by § 1106 and that are not authorized by regulation or by Federal law.
The User further acknowledges that criminal penalties under the Privacy Act (5 U.S.C. § 552a(i) (3)) may apply if
it is determined that the Requestor or Custodian, or any individual employed or affiliated therewith, knowingly and
willfully obtained the file(s) under false pretenses. Any person found to have violated sec. (i)(3) of the Privacy Act
shall be guilty of a misdemeanor and fined not more than $5,000. Finally, the User acknowledges that criminal
penalties may be imposed under 18 U.S.C. § 641 if it is determined that the User, or any individual employed or
affiliated therewith, has taken or converted to his own use data file(s), or received the file(s) knowing that they
were stolen or converted. Under such circumstances, they shall be fined under Title 18 or imprisoned not more
than 10 years, or both; but if the value of such property does not exceed the sum of $1,000, they shall be fined
under Title 18 or imprisoned not more than 1 year, or both.
15. By signing this Agreement, the User agrees to abide by all provisions set out in this Agreement and acknowledges
having received notice of potential criminal or administrative penalties for violation of the terms of the Agreement.
16. On behalf of the User the undersigned individual hereby attests that he or she is authorized to legally bind the User
to the terms this Agreement and agrees to all the terms specified herein.
Name and Title of User

(typed or printed)

Company/Organization
Street Address
City

State

Office Telephone (Include Area Code)

ZIP Code
E-Mail Address

Signature

(If applicable)

Date

17. The parties mutually agree that the following named individual is designated as Custodian of the file(s) on behalf
of the User and will be the person responsible for the observance of all conditions of use and for establishment and
maintenance of security arrangements as specified in this Agreement to prevent unauthorized use. The User agrees
to notify CMS within fifteen (15) days of any change of custodianship. The parties mutually agree that CMS may
disapprove the appointment of a custodian or may require the appointment of a new custodian at any time.
The Custodian hereby acknowledges his/her appointment as Custodian of the aforesaid file(s) on behalf of the
User, and agrees to comply with all of the provisions of this Agreement on behalf of the User.
Name of Custodian

(typed or printed)

Company/Organization
Street Address
City
Office Telephone (Include Area Code)
Signature

Form CMS-R-0235 (03/08)

State

ZIP Code
E-Mail Address

(If applicable)

Date

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 18. The disclosure provision(s) that allows the discretionary release of CMS data for the purpose(s) stated in section 4
follow(s). (To be completed by CMS staff.) _________________________________________
19. On behalf of __________________________________ the undersigned individual hereby acknowledges that
the aforesaid Federal agency sponsors or otherwise supports the User’s request for and use of CMS data, agrees
to support CMS in ensuring that the User maintains and uses CMS’s data in accordance with the terms of this
Agreement, and agrees further to make no statement to the User concerning the interpretation of the terms of this
Agreement and to refer all questions of such interpretation or compliance with the terms of this Agreement to the
CMS official named in section 21 (or to his or her successor).
Typed or Printed Name

Title of Federal Representative

Signature

Date

Office Telephone (Include Area Code)

E-Mail Address

(If applicable)

20. The parties mutually agree that the following named individual will be designated as point-of-contact for the
Agreement on behalf of CMS.
On behalf of CMS the undersigned individual hereby attests that he or she is authorized to enter into this
Agreement and agrees to all the terms specified herein.
Name of CMS Representative

(typed or printed)

Title/Component
Street Address
City
Office Telephone (Include Area Code)

Mail Stop
State

ZIP Code
E-Mail Address

(If applicable)

A. Signature of CMS Representative

Date

B. Concur/Nonconcur — Signature of CMS System Manager or Business Owner

Date

Concur/Nonconcur — Signature of CMS System Manager or Business Owner

Date

Concur/Nonconcur — Signature of CMS System Manager or Business Owner

Date

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
The valid OMB control number for this information collection is 0938-0734. The time required to complete this information collection is estimated to average 30 minutes
per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If
you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn:
Reports Clearance Officer, Baltimore, Maryland 21244-1850.
Form CMS-R-0235 (03/08)

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