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 Outside CMS | | 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
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