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HHS/HRSA

RIN: 0906-AA32

Publication ID: Spring 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
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

Timetable:

Action	Date	FR Cite
NPRM	09/08/1994	59 FR 46482
NPRM Comment Period End	12/07/1994	59 FR 46482
Final Action	06/00/1996

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