[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR486.303]



[Page 644]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY 

 

Subpart G_Requirements for Certification and Designation and Conditions 

              for Coverage: Organ Procurement Organizations

 

Sec.  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) 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.