Making more organs available by strengthening the accountability of organ procurement organizations (OPOs) and removing financial barriers to living organ donation are the aims of two proposed rules released by the US Department of Health and Human Services (HHS) in December 2019.
Increasing the availability of organs for transplantation and supporting living donors have been long-standing priorities of ASN. The society has called for the use of objective and verifiable metrics to assess OPO performance in several communications to the Centers for Medicare & Medicaid Services (CMS) and supported legislation by Sen. Todd Young (IN) that establishes similar practices. ASN has similarly advocated for the expansion of assistance offered to living donors, who often face steep financial barriers to being an organ donor.
The proposal for OPOs would improve current methods of measuring OPO performance by using “objective and reliable data, incentivize OPOs to ensure all viable organs are transplanted, and hold OPOs to greater oversight while driving higher OPO performance,” stated CMS, which contracts with and funds OPOs. Currently, OPO performance is measured using non-standardized and self-reported data, making it hard to differentiate between high- and low-performing OPOs and determine areas for improvement.
To further encourage the dissemination of best practices among OPOs, CMS has proposed that all OPOs must meet the donation and transplantation rate of the top 25% of OPOs in a process that is transparent to the public. CMS estimates that “if all OPOs were to meet both the donation and transplantation rate measures in their donation service area, the number of annual transplants would increase from about 32,000 to 37,000 by 2026, for a total of almost 15,000 additional transplants during [the time between finalization of the proposed rule in 2022 and 2026],” according an agency release. In addition, OPOs would be evaluated each year throughout their four-year recertification cycle, instead of at the four-year mark, as is currently the case, allowing for earlier identification of opportunities for improvement.
“Today’s tremendous news truly transforms the landscape for kidney patients, providing hope and a path to positive change for the future,” said Michelle A. Josephson, MD, FASN, transplant nephrologist and incoming ASN Policy and Advocacy Committee chair. “Bringing transparency to organ procurement organizations’ performance opens the door to improving transplant availability and access for patients.”
“This is a strategy that will help increase the number of kidneys available to patients,” said Richard A. Knight, president of the American Association of Kidney Patients (AAKP). “AAKP will continue to educate patients so they understand how the system works.” Knight also serves on the HHS Health Resources and Services Administration (HRSA) Scientific Registry of Transplant Recipients, which provides oversight for OPOs.
The Association of Organ Procurement Organizations (AOPO), representing the 58 federally designated OPOs across the country, responded in a statement: “The AOPO welcomes today’s rulemaking from CMS as an opportunity to drive meaningful changes that will increase the availability of organs for transplant and save more lives.”
The proposed rule for living kidney donors incentivizes donation by “expanding the scope of reimbursable expenses incurred by living organ donors to include lost wages and childcare and elder care expenses incurred by a primary caregiver,” according to HRSA, which issued the rule.
Many of the proposed changes would not take effect until 2022, but they garnered high praise from the kidney community.
“These changes are great for nephrology and, more importantly, are a tremendous boost for patients, their families, and potential American donors,” said ASN President Mark E. Rosenberg, MD, FASN. “Living donors literally give the gift of life when they donate a kidney and they deserve our society’s complete support. Today’s proposal to reimburse their lost wages and help with child and elder care costs during donation are long overdue.”