---
kind: "section"
citation: "42 C.F.R. § 486.303"
title: "42"
number: "486.303"
heading: "Requirements for certification."
url: "https://uscodex.org/cfr/42/486.303"
---

# §486.303. Requirements for certification.


In order to be certified as a qualified organ procurement organization, an organ procurement organization must:

- (a) Have received a grant under [42 U.S.C. 273(a)](/usc/42/273.md?p=a) or have been certified or re-certified by the Secretary within the previous 4 years as being a qualified OPO.
- (b) Be a non-profit entity that is exempt from Federal income taxation under section 501 of the Internal Revenue Code of 1986.
- (c) Have accounting and other fiscal procedures necessary to assure the fiscal stability of the organization, including procedures to obtain payment for kidneys and non-renal organs provided to transplant hospitals.
- (d) Have an agreement with CMS, as the Secretary's designated representative, to be reimbursed under title XVIII for the procurement of kidneys.
- (e) Have been re-certified as an OPO under the Medicare program from January 1, 2002 through December 31, 2005.
- (f) **Have procedures to obtain payment for non-renal organs provided to transplant centers.**
- (g) Agree to enter into an agreement with any hospital or critical access hospital in the OPO's service area, including a transplant hospital that requests an agreement.
- (h) Meet the conditions for coverage for organ procurement organizations, which include both outcome and process performance measures.
- (i) Meet the provisions of titles XI, XVIII, and XIX of the Act, section 371(b) of the Public Health Services Act, and any other applicable Federal regulations.

## Notes

### Source

Source: 71 FR 31046, May 31, 2006, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.