CMS-576

Organ Procurement Request for Designation as an OPO

Agency
CMS
Revision
01/93
Fillable fields
62
Pages
3
Official source
CMS form page
Checked
October 20, 2026
Fill CMS-576 online
Page 1 of form CMS-576

Form CMS-576: Organ Procurement Organization (OPO) Request for Designation as an OPO

Form CMS-576 is the Organ Procurement Organization (OPO) Request for Designation as an OPO under section 1138 of the Social Security Act, from the Centers for Medicare & Medicaid Services. The form says submitting it starts the process of deciding whether the Conditions for Coverage for OPOs are met, and that its data also helps answer questions from Congress, Federal agencies and the public.

It has five items: identifying information and the service area, type of control, administration and staffing, a narrative with supporting documentation, and performance figures for the 2 calendar years before the year of designation. An authorized official signs it in ink.

The form says to return the original form and the signed agreement to the regional office serving your area and keep a copy. 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-576: Organ Procurement Organization (OPO) Request for Designation as an OPO, as printed by CMS

What's on Form CMS-576

Item I: Identifying information

Facility name, address, phone, chief executive and provider numbers, plus the service area: the areas served or the State, geographic boundaries, total population, and acute care hospitals with an operating room and the equipment and personnel to retrieve organs.

Item II: Type of control

Check all that apply: independent, hospital-based, individual, profit, corporation, nonprofit under section 501, partnership, Federal government or State government.

Item III: Administration and staffing

Names and titles of Board of Directors and Advisory Board members who represent 11 listed groups, from a hospital administrator and transplant surgeons to members of the public residing in the area.

Item IV: Narrative

Twelve questions with supporting documentation, covering hospital working relationships, organ allocation, tissue typing, accounting, potential donors, tissue banks, HIV testing, transplant centers, confidentiality, professional education and hospital protocols.

Item V: Performance

For two calendar years: actual donors, kidneys transplanted and recovered, extrarenal organs recovered and transplanted, and the average number of organs procured per donor.

Signature

The authorized official signs in ink and dates the form, under a warning about false statements and failing to disclose the information requested.

The instructions say to answer all questions as of the current date.

How to fill out Form CMS-576

  1. 1

    Read the cover sheet

    The form asks that the instructions and information collection statement on its cover sheet be read before completing it.

  2. 2

    Complete Item I

    Enter the facility details and describe the service area. A separate sheet can be attached if more space is needed.

  3. 3

    Fill in Items II and III

    Check the type of control and list the board members who represent each group named on the form.

  4. 4

    Answer the narrative and attach documents

    The instructions say the preferable documentation is a copy of the written agreements with hospitals and transplant centers in the service area.

  5. 5

    Report performance

    Enter the Item V figures for the 2 calendar years before the year of designation.

  6. 6

    Sign and return it

    Sign in ink, then return the original form and the signed agreement to the regional office serving your area, keeping a copy.

Why fill Form CMS-576 on indox

You get the real form, filled in a browser tab, with nothing standing between you and the finished PDF.

  • Fill the form right in your browser, no software to install
  • Free to fill and free to download, with no account
  • The official blank straight from the CMS, not a copy someone retyped
  • Works on a phone, tablet or computer

Where it goes and what the form says

Where to send it

To the regional office serving your area, according to the form. The form says the regional offices' names, addresses and service areas are attached, but the PDF on the CMS page does not include that list.

Not returning the form

The form says failure to return it may result in termination for the service area.

Letters of intent

Without a written agreement with a facility, the instructions say a letter of intent from a hospital or transplant center to enter into one within 12 months of designation is accepted. Without either, other documentation of the working relationship is asked for.

Yearly figures

The Item V performance information is to be submitted 15 days following the end of each calendar year, the form says.

Time to complete

The form estimates an average of 2 hours per response.

Who uses Form CMS-576?

  • Organizations seeking OPO designation

    The form is the request for designation as an OPO under section 1138 of the Social Security Act.

  • First-time requests

    The instructions say to leave the six digit Medicare provider number blank on an initial request for designation.

  • OPOs affiliated with another provider

    If the OPO is affiliated with any other Medicare provider, the instructions ask for that facility's six digit Medicare provider number.

  • Yearly performance reports

    The form says the Item V performance information is to be submitted 15 days following the end of each calendar year.

  • CMS regional office

    Several boxes at the top are for CMS regional office use only, and the instructions say the regional office completes the State/County and State Regional codes.

The form is a request from an organ procurement organization for designation as an OPO.

Official sources and the blank

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Questions about Form CMS-576

Where do I send Form CMS-576?

The form says to return the original form and the signed agreement to the regional office serving your area and make a copy for your files.

Do I enter a Medicare provider number on a first request?

No. The instructions say to leave the six digit provider number blank on an initial request for designation.

What documentation does the narrative need?

The instructions say the documentation should explain the OPO's plans or systematic efforts to provide its services, and that the preferable documentation is a copy of the written agreements with hospitals and transplant centers in the service area.

What if there is no written agreement with a hospital?

The instructions say a letter of intent to enter into an agreement within 12 months after designation is accepted. Without either, the form asks for other documentation of the working relationship.

Which years go in Item V?

The form says the procurement activity is for the 2 calendar years prior to the year of designation.

Who signs Form CMS-576?

The authorized official, in ink, with the date.