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Conditions for Coverage (CfCs) & Conditions of Participations (CoPs)

Organ Procurement Organizations (OPOs)

Publication date:         

    Existing regulations published May 2, 1996

    Final rule, CMS-3064-F, published May 31, 2006

Effective date:

    Current regulations effective May 31, 1996

    Proposed rule, public comment period ended June 6, 2005. 

    Final rule effective July 31, 2006

CFR section numbers:

    42 CFR §486.301-325 (current regulations)

    42 CFR Parts §§486.301-348, et al. (proposed rule)

    42 CFR Parts §§486.301-348, et al. (final rule)

CFR section descriptions:

    42 CFR §§486.301-310, Conditions for Coverage; Organ Procurement Organizations

    42 CFR Parts 413, 441, 486 and 498, Conditions for Coverage for Organ Procurement Organizations (OPOs); Proposed Rule

    42 CFR Parts 413, 441, 486 and 498, Conditions for Coverage for Organ Procurement Organizations (OPOs); Final Rule

Brief description of document(s):

    42 CFR §§486.301-325 describes the conditions and requirements that OPOs must meet to be designated, certified, and receive payment from the Medicare and Medicaid programs. 

    The proposed rule, 42 CFR Parts 413, 441, 486 and 498, updates the current conditions and requirements for OPOs to be designated, certified, and receive payment from the Medicare and Medicaid programs, and describes new conditions and requirements for the OPOs, including the use of organ donor potential instead of population in determining outcome performance measures, a new appeals process, and new process performance measures.

    This rule finalizes the February 4, 2005, proposed rule on Conditions for Coverage for OPOs, CMS-3064-P, and re-certifies all of the existing 58 OPOs from August 1, 2006 through July 31, 2010.  It also provides that the OPOs’ agreements with the Secretary for this certification cycle will end on January 31, 2011.  In addition, this final rule establishes new conditions for coverage, including new outcome and process performance measures, a new appeals process, and a new competition process.


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Related Links Inside CMS

There are no Related Links Inside CMS
Related Links Outside CMSExternal Linking Policy
Proposed rule

Final Rule

The Health Resources and Services Administration’s (HRSA’s) Breakthrough Collaborative

The Scientific Registry of Transplant Recipients

United Network for Organ Sharing

Organ Procurement and Transplantation Network

Page Last Modified: 12/14/2005 12:00:00 AM
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