On May 8, 2015, the Health Resources and Services Administration (HRSA) published a final rule to implement the HIV Organ Policy Equity Act (HOPE Act), which modifies standards related to Organ Procurement Transplantation Network (OPTN) acquisition of organs from individuals known to be infected with human immunodeficiency virus (HIV). Under the final rule, organs from individuals infected with HIV may be transplanted into individuals who are infected with HIV before receiving such organs and who are participating in clinical research approved by an institutional review board. While the HOPE Act provides the Secretary with discretion to determine what criteria should apply to the conduct of such research, the Secretary is not promulgating research criteria at this time. The rule also provides that the Secretary may determine in the future that participation in clinical research as a requirement for transplants of organs from individuals infected with HIV is no longer warranted. Because the changes made by this rule directly implement changes made by the HOPE Act, and because the Secretary is not undertaking discretionary rulemaking, the Secretary is waiving the public notice and comment procedures with regard to this policy. The rule is effective June 8, 2015.
This article is presented for informational purposes only and is not intended to constitute legal advice.
