On December 17, the U.S. Department of Health and Human Services (HHS) announced steps to increase the availability of organs for the 113,000 Americans on organ waitlists.
As directed by President Trump in his July 10 Executive Order on Advancing American Kidney Health, the Centers for Medicare & Medicaid Services (CMS) is issuing a proposed rule to change the way organ procurement organizations (OPOs) are held accountable for their performance, and the Health Resources and Services Administration (HRSA) is issuing a proposed rule to remove financial barriers to organ donation.
“The American Society of Transplant Surgeons applauds the Administration’s continued efforts to improve access to transplantation by increasing the organ supply, and hence the number of transplants,” said Lloyd E. Ratner, MD, MPH, ASTS President. “By increasing the number of transplants, we are confident that deaths on the waiting list will be lessened, a goal we share with the Administration. Increasing the number of organs available by modifying performance metrics for Organ Procurement Organizations and removing disincentives to living organ donation by covering expenses for lost wages, child care, and elder care through the National Living Donor Assistance Center are two promising avenues to address the unmet need for organs. We look forward to working with the Ce nters for Medicare and Medicaid Services and the Health Resources and Services Administration on operationalizing optimal proposals, once they are finalized.”
ASTS plans to submit comments as appropriate and encourages all members to weigh in on both proposals. Public comments are due 60 days after publication of the rules in the Federal Register.
CMS estimates that if all OPOs were to meet both the donation and transplantation rate measures, 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 in that time.
The proposed rule would use objective and reliable data, incentivize OPOs to ensure all viable organs are transplanted, and hold OPOs to greater oversight while driving higher OPO performance. CMS is proposing:
- Donation rate measure: The donation rate would be the number of actual deceased donors as a percentage of the donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.
- Transplantation rate measure: The organ transplantation rate would be the number of organs transplanted as a percentage of the donor potential, which would be defined as total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not preclude a potential donor from donating an organ.
- Top 25 percent benchmark: CMS is proposing that all OPOs meet the donation and transplantation rates of the current top 25 percent of OPOs, which would be made public.
- 12-month reviews: At the end of each re-certification cycle (every four years), an OPO would have to meet the CMS requirements for both the donation rate and transplantation rate measures. CMS is proposing to review OPO performance every 12 months throughout the four year re-certification cycle to more quickly identify OPOs that need improvement and ensure fewer viable organs are wasted and more timely transplants occur.
Most of the proposed changes would not take effect until 2022. However, CMS intends to make these outcome measures public during the next four-year OPO recertification cycles once the rule is finalized.
Comment on OPO metrics proposed rule
HRSA’s proposed rule would expand the scope of reimbursable expenses for living donors to include lost wages, and childcare and eldercare expenses for those donors who lack other forms of financial support via the National Living Donor Assistance Center. This proposal could increase the number of transplant recipients receiving a better quality organ in a shorter time period from living donors. HRSA also is reviewing a notice that would increase the income threshold for living donors eligible for reimbursements.
Comment on HRSA Proposed Rule