In the wake of a review by the White House’s U.S. Digital Service that revealed that the technology that matches donated kidneys, livers and hearts to patients has failed repeatedly, ASN stands by its ongoing advocacy efforts of recent years to improve the transplantation system to increase equitable access for all patients who would benefit from organ transplantation. As discussed in an article in the Washington Post, the review points to problems such as security vulnerabilities, aged software, periodic system failures, mistakes in programming, and over-reliance on manual input of data. The Washington Post also describes a history of resistance to government oversight from the current OPTN contractor, which one former HHS general counsel characterized as “the most topsy-turvy relationship I’ve ever seen” in the article. The Senate Finance Committee will conduct an oversight hearing on the system today.
In May, in a letter to the Health Resources and Health Administration (HRSA), ASN recommended separating the technology portion of the Organ Procurement and Transplantation Network (OPTN) contract as a stand-alone contract, as well as ensuring technology systems developed for federally funded contracts belong to the Agency. Under current contract requirements, OPTN is responsible for maintaining an organ waiting list and an information technology system to match organs with patients, developing transplant policy, monitoring performance, and conducting oversight of transplant centers and Organ Procurement Organizations (OPOs). Representatives of both transplant centers and OPOs comprise the board of OPTN. The current OPTN contractor maintains the information technology infrastructure as a proprietary tool, according to the Washington Post, stating they would charge taxpayers $55 million for system rights despite the system being created through taxpayer and user fee funding.
HRSA oversees the contractor for OPTN, United Network for Organ Sharing (UNOS), the non-profit agency that operates the transplant system. According to UNOS, more than 100,000 people are currently on the waiting list for organs, and an average of 22 people die every day waiting for them. Of this number, 90,000 are on the waitlist to receive a kidney, and an average of 13 people die every day waiting for a kidney. Transforming the transplant system also presents an opportunity achieve equity. For example, Black Americans wait an average of 2 years longer to receive a kidney than White Americans. In February, in a letter to the Centers for Medicare & Medicaid Services (CMS), ASN provided extensive comments advocating for a complete overhaul of the transplantation system. HRSA and CMS both share oversight of the system.
ASN has recommended that OPTN contractors have complete and accurate data readily available so that all stakeholders can have timely evidence of equitable and effective treatment of donors and patients. “The OPTN data registry is an important asset for the transplant community, and yet the OPTN contractor has failed to ensure that there are important quality checks in place in the form of data validation, verification at the time of data entry, the elimination of biological implausible values and/or the ensuring that there is a robust, verifiable and reproducible method to confirm that all deaths and graft failures are accurately captured,” the ASN letter to HRSA states. “Large errors for critical data suggest that the OPTN contractor does not view the maintenance of the registry as a critical function. The absence of a robust data dictionary with detailed instructions and definitions are another example of the failure to invest in the data capture system.”
ASN has also asked for enforcement on the requirement (called for by HRSA in 2018 and reaffirmed by the US Government Accountability Office) that OPTN and contractor(s) have separate governance boards. “The current governance of the OPTN contractor is perceived as opaque to the community with no clear process for how individuals who volunteer for participation are selected to serve on committees,” the letter points out. “ASN believes separate governance boards is an important first step in addressing this and other issues. In addition, there needs to be the ability to invite external experts or even require that committees identify experts who would be able to inform committee discussions.”
ASN urged CMS to improve transplant programs by standardizing communications to patients; providing process measure data like “time to transplant”; making web-based information patient friendly and understandable; ensuring patient selectivity and transplant center thresholds are transparent; and providing real-time updates for waitlisted patients.
To improve the current transplant program Conditions of Participation (CoPs) and incentivize performance quality in organ transplantation, ASN has recommended a system-wide alignment. “The Conditions of Participation (CoPs) for dialysis facilities and transplant centers are not aligned and do not recognize the role of both in facilitating a smooth transition of care for patients,” the letter states.
ASN therefore recommended that CMS reverse OPTN Board approval of a new policy combining pretransplant (offer acceptance, waitlist mortality) and posttransplant (90-day graft survival and conditional one-year graft survival) indicators. The OPTN recommendations developed by the OPTN Membership and Professional Standards Committee were of great concern to ASN for the lack of clarity, meaningfulness, transparency and consistency in the proposals (see letter to OPTN).The society also supported aligning measures in ESRD Treatment Choices (ETC) model and the ESRD Quality Incentive Program (QIP); incentivizing maximum access to waitlists, optimal organ use, and transplant rates, while maintaining post-transplant outcomes; and helping patient-centered CoPs through robust pre and posttransplant care.
ASN has also offered suggestions on how CMS could improve communication between Organ Procurement Organizations (OPOs), donor hospitals, and transplant programs. Encouraging minimum requirements to adequately staff transplant programs, including the pretransplant coordinator and living donor teams, staff reviewing organ offers, and staffing models for posttransplant care would be a good first step. Increasing communications efforts between OPOs and transplant centers, as well as increasing accountability of transplant centers for organs that are declined on behalf of patients when these organs are of excellent quality would also help.
Moreover, ASN specifically recommended that CMS address issues of technology and infrastructure impacting DonorNet, organ centers, bypass filters, decline codes, inadequate oversight of process measures as evidenced by out of sequence offers, and data quality.
Stakeholders and issue experts from both public and private sectors have recommended splitting the information technology infrastructure into a separate contract or requiring modernization when UNOS’s current contract comes up for rebidding, including five former Chief Technology Officers of the Department of Health and Human Services and the National Academies of Sciences, Engineering and Medicine. “HHS should ensure that the OPTN uses a state-of-the-art information technology infrastructure that optimizes the use of new and evolving technologies to support the needs and future directions of the organ transplantation system,” the Academies emphasized in a report. “The organ transplantation system could save additional lives and be more equitable if its component parts functioned in a more cohesive fashion and were overseen by a single entity, or by several entities operating in a coordinated fashion with common goals and unified policies and processes.”