HHS has released additional details about an initiative that aims to increase accountability and transparency in the nation’s organ transplant system.
HHS announced eight reforms to the Organ Procurement and Transplantation Network and organ procurement policies in a Sept. 18 news conference. Here’s what to know:
1. For the first time, the Health Resources and Services Administration, an HHS agency, separated from the contractor that ran the OPTN board and launched an independent board of 34 members via a national special election.
2. HHS Secretary Robert F. Kennedy Jr. directed all organ procurement organizations to appoint a OPTN patient safety officer that will monitor and investigate patient safety events, document and report incidents and adverse events to OPTN, lead root-cause analysis, ensure corrective action is implemented and be the first point of contact for family, hospital partners and HRSA.
3. HRSA launched a public dashboard to flag organ allocation out of sequence when patients are skipped contrary to policy; opened a direct, anonymous reporting channel for patient safety complaints; and are reviewing and changing key policies including strengthening procurement safety through clear directives.
4. The agency is moving away from a single contractor to a multi-vendor environment to improve transparency and oversight into how patient registration fees support the OPTN operations.
5. The FDA is removing the tuberculosis testing requirements, meaning physicians no longer have to perform the test if they do not believe it is necessary. This change is designed to prevent delays.
6. HHS Deputy Secretary Jim O’Neill announced a $25 million living organ donation reimbursement fund that will be used to reduce the financial burden on living organ donors by providing reimbursements for non-medical expenses, such as lost wages, travel and lodging, meals and independent care.
7. HHS has green-lit the first clinical trials for genetically modified pig kidneys to expand supply. The agency is also supporting organizations that are exploring bioprinting and regenerative medicine and 3D-printed personalized organs.
8. In a first, CMS decertified the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, Medicare participation midcycle on Sept. 18. The decision was made after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing and paperwork errors. The system can appeal the decertification in a monthslong process.
“The reason we’re taking aggressive action against failing organ procurement organizations is to make sure that the strong ones continue to thrive,” CMS Administrator Mehmet Oz, MD, said in a Sept. 18 agency press conference.
The Life Alliance Organ Recovery Agency said it does not intend to appeal the decertification.
“The top priority of the Life Alliance Organ Recovery Agency has always been safe, respectful, and compliant organ donation practices,” the group said in a statement on its website. “We hope that other OPOs follow suit in putting patients first. Our focus remains on protecting the dignity of donors, supporting their families, and advancing the life-saving mission of organ transplantation.”
9. In July, HRSA directed OPTN to improve national monitoring and reopen an investigation into Network for Hope, previously known as Kentucky Organ Donor Affiliates before a merger. The audit found that, among about 350 cases in which Network for Hope halted organ procurement plans, 73 patients showed improving or high levels of consciousness. Twenty-eight patients may also not have been deceased at the time of organ preparation. Network for Hope denied the finding, said it adheres to federal regulations and is considering updating its practices. The investigation closed without action.
