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1991.06.21 :  Regulation -- Organ Procurement

Contact:  Bob Hardy (202) 245-6145
June 21, 1991

        HHS Secretary Louis W. Sullivan, M.D., today proposed a
regulation requiring that organs be tested to ensure they are not
infected with the AIDS virus before they are supplied to
hospitals for transplantations.
        Secretary Sullivan said that "everybody in the health
care field must recognize the need to employ every possible
safeguard to protect the patients under our care from infection
by the deadly AIDS virus. Ensuring the quality of organs for
transplantations is one important step we can take with available
technology."
        Under the proposed rule published in the Federal
Register, Organ Procurement Organizations must guarantee that
appropriate tests have been conducted to ensure that the organs
they provide to hospitals for transplantations are free of the
AIDS virus.
        The proposed regulation sets forth new requirements that
Organ Procurement Organizations (OPOs) must meet to have their
services covered by payments from the Medicare and Medicaid
programs.
        Gail R. Wilensky, Ph.D., administrator of the Health Care
Financing Administration, said that an OPO which fails to meet
the requirements can be terminated from the Medicare and Medicaid
programs and lose its designated service area to another organ
procurement organization.
        She explained that the requirements governing organ
procurement activities ensure the quality of care and protection
for all patients receiving organ transplants, not just Medicare
and Medicaid patients.
        Dr. Wilensky said that some provisions of the new
requirements, including the testing of organs for AIDS, will
cause a marginal increase in the costs of the organ-procurement
process.
        "However," she said, "the costs are minimal compared to
the greater quality assurance provided by the new requirements."
        The proposed regulation requires that a designated OPO
service area be "of sufficient size to ensure maximum
effectiveness in the procurement and equitable distribution of
organs." 
        Other sections set forth conditions for termination of
OPOs from the Medicare and Medicaid programs.
        Comments on the proposed rule will be considered if
submitted within 60 days to the Health Care Financing
Administration, Attention: BPD-646-P, P.O. Box 26676, Baltimore,
Md. 21207.


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