[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: 42CFR486.301]



[Page 641-642]

 

                         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.  486.301  Basis and scope.



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





    (a) Statutory basis. (1) Section 1138(b) of the Act sets forth the 

requirements that an organ procurement organization (OPO) must meet to 

have its organ procurement services to hospitals covered under Medicare 

and Medicaid. These include certification as a ``qualified'' OPO and 

designation as the OPO for a particular service area.

    (2) Section 371(b) of the Public Health Service Act sets forth the 

requirements for certification and the functions that a qualified OPO is 

expected to perform.

    (3) Section 1102 of the Act authorizes the Secretary of Health and 

Human



[[Page 642]]



Services to make and publish rules and regulations necessary to the 

efficient administration of the functions that are assigned to the 

Secretary under the Act.

    (4) Section 1871 of the Act authorizes the Secretary to prescribe 

regulations as may be necessary to carry out the administration of the 

Medicare program under title XVIII.

    (b) Scope. This subpart sets forth--

    (1) The conditions and requirements that an OPO must meet;

    (2) The procedures for certification and designation of OPOs; and

    (3) The terms of the agreement with CMS and the basis for and the 

effect of de-certification.

    (4) The requirements for an OPO to be re-certified.