Organ Procurement and Transplantation Network:

Legal Liability and Data Confidentiality

OGC-99-47R: Published: May 3, 1999. Publicly Released: May 3, 1999.

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William J. Scanlon
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Pursuant to a congressional request, GAO provided information on the Organ Procurement and Transplantation Network (OPTN), focusing on the impact of proposed Department of Health and Human Services' (HHS) modifications on the: (1) confidentiality of information about the program; and (2) possible legal liability of members of the Network arising from their peer review activities.

GAO noted that: (1) the supply of organs has not kept pace with the demand; (2) in 1998, according to HHS, about 21,000 organs were transplanted, yet by the end of that year over 62,000 individuals were waiting for transplants; (3) the OPTN allocates organs largely on a local or regional basis; (4) transplant centers employ different criteria for determining who needs transplantation, and for determining the greatest medical need among transplant candidates; (5) HHS believes the system of regional allocation is inequitable in that organs do not necessarily go to the sickest patients; (6) HHS sought comment in April of last year on a final rule that would have changed the allocation of organs by the OPTN to a national approach, with prioritization of transplant candidates to be based on standard medical criteria; (7) HHS' approach generated substantial concern; the current contractor and others believe it would have an adverse effect on the program; (8) Congress enacted legislation postponing the effective date of the final rule from July 1998 until October 1999, and requiring GAO to contract with the Institute of Medicine for a study of OPTN policies and the proposed final rule; (9) if the rule took effect in its present form, it is feared, state laws immunizing peer reviews from lawsuits based on their evaluations and guaranteeing confidentiality of information used in that process might be preempted by the federal requirements embodied in the final rule, leaving reviewers vulnerable to suits and less willing to participate and be candid in the peer review process; (10) GAO concludes that the rule's preemption provision is unlikely to affect the availability of peer review liability protection; (11) concerns about disclosure of information related to the conduct of peer review are not unfounded, but are not solely the result of the HHS rule; (12) the risk of such disclosure exists now in those states that do not provide statutory immunity for peer reviewers or that define peer review in such a way that their immunity provisions might not protect the peer review activities of the OPTN; (13) where state law immunizes peer reviewers from suit, it would not be preempted by HHS' rule, but the Secretary could preempt state laws that regulate disclosure of information about peer review if she were to determine, as the rule provides, that disclosure is in the public interest; and (14) whether or not state law in fact protects them, peer reviewers' perception that their deliberations might be disclosed or that they might be sued because of what they do might affect their performance.

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