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1994.09.08 : Organ Procurement & Transplantation Rules 

Contact:  Anne Verano (HCFA)          (202) 690-6145
          Patricia Campbell (HRSA)    (301) 443-3376   
Thursday, Sept. 8, 1994      
                                           

    HHS PUBLISHES ORGAN PROCUREMENT AND TRANSPLANTATION RULES


     Performance standards for organizations that procure organs 
for transplantation were announced today by HHS Secretary Donna E.
Shalala.

     "The availability of organs is falling tragically short of
need," the secretary said.  "We are insisting on effective
management and coordination of activities to encourage organ
donations and then to ensure equitable allocation to eligible
patients."

     Sixty-six organ procurement organizations exist in the United
States.  A total of 17,527 organ transplants were performed in 1993,
up from 16,581 in 1992.  More than 36,000 individuals needing
transplants are waiting for organs.

     The regulation published in today's Federal Register
establishes requirements that organ procurement organizations (OPOs)
must meet to be eligible for payments by the Medicare and Medicaid
programs.

     Bruce C. Vladeck, administrator of the Health Care Financing
Administration, said the regulation requires OPOs to report data
that "will provide us with a comprehensive overview of organ
procurement activities in the United States.  These data are 
essential for developing strategies to serve the fast-growing need
for organs."

     "Because dramatic improvements in transplantation technology
have increased survival rates, growing numbers of patients are
seeking organ transplants," Vladeck said.

     Under the regulation, each OPO's service area must be large
enough to ensure maximum effectiveness in the procurement and
equitable distribution of organs.

     An organization applying for designation as an OPO for the
first time must produce evidence that its proposed service area has
the potential to produce 50 donors per calendar year.

     OPOs will be required to procure at least 24 donors per
calendar year over a two-year period and maintain an average
procurement ratio of three organs per donor.

     The regulation requires that each existing OPO provide yearly
data on the number of donors, the number of kidneys recovered, the
number of kidneys transplanted, and the numbers of other kinds of
organs recovered and transplanted.

     At the same time, HHS today proposed rules that would establish
requirements and procedures for membership in the Organ Procurement
Transplantation Network, for listing transplant candidates on a 
national computer network, for allocating organs and for reporting
and record-keeping.

     The Organ Procurement Transplantation Network maintains a
national computerized list of patients waiting for organ transplants
and a 24-hour-a-day computerized organ placement center to match 
donors and recipients.  Its purpose is to ensure equitable access to
organs by critically ill and medically qualified patients and to
guarantee that scarce organs are recovered and used appropriately
and efficiently.  It is operated by the Health Resources and
Services Administration, an agency of the Public Health Service,
through a contract awarded to the United Network for Organ Sharing.

     Written comments on the HRSA proposal should be sent within the
90-day comment period, which ends Dec. 7, 1994, to:  Ms. Judith
Braslow, Director, Division of Organ Transplantation, Bureau of
Health Resources Development, Health Resources and Services
Administration, 5600 Fishers Lane, Rm. 7-18, Rockville, Md. 20857.

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