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HHS/HRSA | RIN: 0906-AA32 | Publication ID: Fall 1996 |
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 or provide any benefit other than that which now exists. | |
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: No | 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 |
Statement of Need: These regulations are required by law. |
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Summary of the Legal Basis: 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). |
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Alternatives: The alternative was to continue without codifying existing policies. |
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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. |
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Risks: None known. |
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Timetable:
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Additional Information: Previously reported under RIN 0905-AD26. | |
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Included in the Regulatory Plan: Yes | |
Agency Contact: Judith Braslow Director, Division of Transplantation, Office of Special Programs Department of Health and Human Services Health Resources and Services Administration Room 7-29, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857 Phone:301 443-7577 |