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HHS/HRSA RIN: 0906-AA32 Publication ID: Spring 1998 
Title: Organ Procurement and Transplantation Network Rules 
Abstract: Section 1138 of the Social Security Act requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) as established by section 372 of the Public Health Service Act. Section 1138 also requires that for organ procurement costs attributable to payments to an Organ Procurement Organization (OPO) to be paid by Medicare or Medicaid, the OPO must be a member of and abide by the rules and requirements of the OPTN. No other entity (for example, a histocompatibility laboratory) is required to be a member of or abide by the rules of the OPTN under the provisions of the statute. It is the Department's position that no rule, requirement, policy, or other issuance of the OPTN will be considered to be a "rule or requirement" of the Network within the meaning of section 1138 unless the Secretary has formally approved that rule. The OPTN is currently in operation and these rules will impose no further cost. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 121   
Legal Authority: 42 USC 1320b-8 sec 1138 of the Social Security Act    42 USC 274 sec 372 of the Public Health Service Act    42 USC 274b sec 374 of the Public Health Service Act    42 USC 216 sec 215 of the Public Health Service Act   

Statement of Need: These regulations are needed to establish a legally binding framework for the operation of the OPTN and for participation in the OPTN by transplant hospitals and OPOs.

Summary of the Legal Basis: Section 215 of the Public Health Service Act, along with the provision of sections 372 and 374 of the Act (42 USC 216, 274 and 274, respectively) provide authority to issue OPTN regulations. In addition section 1138 of the Social Security Act (42 USC 1320b-8) requires Medicare and Medicaid participating hospitals that perform organ transplants to be members of and abide by the rules and requirements of the Organ Procurement and Transplantation Network (OPTN) as established by section 372 of the Public Health Service Act (42 USC 274).

Alternatives: The alternative was to continue without codifying existing policies.

Anticipated Costs and Benefits: There are no anticipated costs beyond the cost of preparing the regulations (approximately $100,000.00). The anticipated benefit is that the regulations will make mandatory adherence to the policies set forth in the regulations.

Risks: None known.

Timetable:
Action Date FR Cite
NPRM  09/08/1994  59 FR 46482   
NPRM Comment Period End  12/07/1994    
Final with Comment Period  04/02/1998  63 FR 16296   
Comment Period End  06/01/1998    
Additional Information: Previously reported under RIN 0905-AD26. ^PSections 215, 372, and 374 of the PHS Act provide general authority to regulate the activities of the Organ Procurement and Transplantation Network (OPTN) established under section 372.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Included in the Regulatory Plan: Yes 
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