A bill to amend the Public Health Service Act to revise and extend provisions relating to the Organ Procurement and Transplantation Network.
Directs the Secretary of Health and Human Services to establish the Scientific Advisory Committee on Organ Transplantation, empowering it to disapprove of comments or revisions by the Secretary to policies revised or reaffirmed by the Board. Prohibits, when the Committee so disapproves, revised or reaffirmed policies from becoming effective until the Committee approves the policy or revisions. Requires that Committee members be appointed by the Secretary.
Requires the Comptroller General to study and report to appropriate congressional committees on the review process for enforceable transplant policies under these provisions, examining the Advisory Committee's role.
Directs the Secretary to contract, through competitive bidding, with a nonprofit private entity for Network administration and operation (Administrator). Limits contracts to five years.
Authorizes the Administrator to assess and collect fees for Network membership and listing of potential recipients in amounts that are reasonable and customary and sufficient to cover Network operational costs.
Requires the Board and Administrator to monitor Network participants' operations for compliance with Board criteria and policies. Requires the Board to establish a peer review system and conditions for the application of peer review requirements to ensure compliance. Requires the Board or Administrator to advise the Secretary on action concerning noncompliance or a risk to the health of transplant patients or public safety. Authorizes the Board or the Secretary to impose sanctions for violations.
Authorizes appropriations.
(Sec. 3) Directs the Secretary, by contract, to develop and maintain a scientific registry of transplant recipients.
(Sec. 4) Directs the Secretary to establish an interagency task force on organ donation and research to improve coordination and evaluation of federally supported or conducted organ donation and basic, clinical, and health services research. Allows termination of the task force at the discretion of the Secretary after completion of two annual reports. Directs the Secretary: (1) on termination, to provide for ongoing coordination; (2) directly or though grants or contracts, to carry out a comprehensive national public education program to increase donation, including living donation; (3) to support the development and dissemination of model curricula to train health care and other professionals (including religious leaders and law enforcement officials) in donation issues, including approach methods and cultural sensitivities; and (4) contract with the Institute of Medicine for an evaluation of the donation practices of organ procurement organizations, States, other countries, and other organizations that have achieved a higher than average organ donation rate and examine existing donation barriers. Authorizes appropriations.
(Sec. 5) Requires that a qualified organ procurement organization, notwithstanding any other provision of law, meet current requirements plus be certified or recertified by the Secretary in the previous four-year period as meeting performance standards through one of two specified processes. Replaces provisions requiring an organ procurement organization to have an allocation system with provisions requiring it to assist the Network in the allocation of organs.
(Sec. 7) Directs the Secretary to provide for a study (directly or by grant to a public or nonprofit private entity) and report to Congress on the costs of immunosuppressive drugs provided to children pursuant to organ transplants and to determine the extent to which health plans, health insurance, and Government programs cover those costs.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S2245-2248)
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported to Senate by Senator Jeffords with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported to Senate by Senator Jeffords with an amendment in the nature of a substitute. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 509.
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