CMS-R-0235L

Data Use Agreement (DUA)- Limited Data Sets

Agency
CMS
Revision
06/20
Fillable fields
50
Pages
6
Official source
CMS form page
Checked
October 20, 2026
Fill CMS-R-0235L online
Page 1 of form CMS-R-0235L

Form CMS-R-0235L: Data Use Agreement (DUA) for CMS Limited Data Sets

Form CMS-R-0235L is the Data Use Agreement (DUA) for Limited Data Sets from the Centers for Medicare & Medicaid Services. It is an agreement between CMS and a requesting organization, which the form calls the User, for limited data set files derived from a CMS Privacy Act System of Records. The form says the agreement is needed so that the disclosure and use of those files comply with the Privacy Act of 1974 and the HIPAA Privacy Rule.

The agreement has 17 numbered sections. The User fills in its name, the study or project, the files and years requested, a retention date, a signature and a custodian for the files. Sections 16 and 17 are completed by CMS staff. Attachment A holds the Research Application Guidelines for the detailed research explanation.

The instructions say the agreement's language cannot be altered in any form. You can fill it out free in your browser on this page and download the result without an account.

Top of page 1 of Form CMS-R-0235L: Data Use Agreement (DUA) for CMS Limited Data Sets, as printed by CMS

What's on Form CMS-R-0235L

Opening paragraph and section 1

The Requestor's or User's organization name, entered in both places.

Section 3: Research purpose

The study or project name, the CMS contract number if applicable, and a brief summary of the purpose. A detailed explanation is attached to the agreement.

Section 4: Files and years

The limited data set files and years of data requested. The instructions ask for specific filenames and say a CMS representative can be contacted if they are unknown.

Section 6: Retention date

The date until which the User may keep the files, entered as the projected completion date of the study or project.

Sections 5 and 7 to 13: Terms

Terms on not identifying or contacting individuals, not linking records without written authorization, cell size suppression, security safeguards, processing fees, reporting unauthorized use, and penalties.

Sections 14 and 15: Signatures

The User's name and title, organization, address, phone, email, signature and date, then the same details and signature for the custodian.

How to fill out Form CMS-R-0235L

  1. 1

    Read the instruction page

    The instructions say the language in the agreement cannot be altered in any form, and list which sections the User completes.

  2. 2

    Enter the organization name

    Write the Requestor's or User's organization name in the first paragraph and in section 1.

  3. 3

    Describe the research purpose

    Complete section 3 and attach the detailed explanation, following the Research Application Guidelines in Attachment A.

  4. 4

    List the files and the retention date

    Name the files and years in section 4 and enter the projected completion date in section 6.

  5. 5

    Sign and name the custodian

    The User completes and signs section 14, and the custodian's details and signature go in section 15.

  6. 6

    Leave sections 16 and 17 for CMS

    The instructions say a CMS representative completes sections 16 and 17.

Why fill Form CMS-R-0235L on indox

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Terms, fees and help

Help with the form

The instructions list the Division of Privacy Compliance Help Line at 410-786-3690 for questions about completing the agreement.

Where it goes

The form does not print a submission address. The CMS address in its Paperwork Reduction Act statement is for comments on the time estimate only.

Cell size suppression

Section 8a says no cell (for example admittances, discharges or patients) less than 11 may be displayed. Written products can be sent for CMS review, which the form says takes 4 to 6 weeks after receipt.

Retention and destruction

Section 6 says the User notifies CMS within 30 days if the purpose is completed before the retention date, then destroys the data and sends written certification of the destruction within 30 days.

Fees

Section 10 says the User reimburses CMS for all processing fees for each limited data set file. The form does not list amounts.

Time to complete

The form estimates an average of 30 minutes per response.

Who uses Form CMS-R-0235L?

  • Requesting organizations

    The User is the requesting organization, named in the first paragraph and in section 1.

  • Research projects

    Section 3 says the files are used solely for the stated research purpose, which has to show the potential to improve the quality of life for Medicare beneficiaries or the administration of the Medicare program.

  • Custodians of the files

    Section 15 names the custodian, the person who will have actual possession of and responsibility for the files. The instructions say to complete it even if the custodian and User are the same.

  • Secondary users

    Section 8b says the files may not go to a Secondary User until that Secondary User enters into its own DUA with CMS.

  • CMS staff

    Sections 16 and 17, the disclosure provisions and the CMS representative's signature, are completed by CMS staff.

The agreement is between CMS and the organization requesting limited data set files.

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Questions about Form CMS-R-0235L

Who signs Form CMS-R-0235L?

An individual authorized to act for the User signs section 14, the custodian signs section 15, and a CMS representative signs section 17.

Can the agreement's wording be changed?

No. The instructions say the language contained in the agreement cannot be altered in any form.

What is the cell size rule?

Section 8a says no cell less than 11 may be displayed, and no percentages or other formulas may be used if they result in displaying a cell less than 11.

How long can the data be kept?

Until the retention date in section 6. The form says that if the purpose is completed sooner, the User notifies CMS within 30 days, destroys the data and sends written certification of destruction within 30 days.

Can the files be shared with another organization?

Section 7 limits disclosure to what the agreement permits or the law requires, and section 8b says a Secondary User first enters into its own DUA with CMS.

What goes in the detailed research explanation?

Attachment A lists an introduction and purpose, project issues and methods, data management safeguards, key personnel, dissemination plans, and a statement on any proprietary information.

Who can I call with questions?

The instructions list the Division of Privacy Compliance Help Line at 410-786-3690.