The Department of Health and Human Services (HHS) has released two proposed rules intended to increase the availability of organs for transplantation and improve the accountability of organ procurement organizations (OPOs), in conformance with President Trump’s Executive Order on Advancing American Kidney Health.

First, the Health Resources and Services Administration has proposed expanding the scope of “incidental non-medical expenses” that are reimbursable for living organ donors to include lost wages and child-care and elder-care expenses.  This proposal is aimed at removing financial barriers and disincentives to organ donation.

Second, the Centers for Medicare & Medicaid Services (CMS) has proposed revising the current OPO Conditions for Coverage, effective for the 2022 re-certification cycle.  CMS’s stated intention is to ensure that the outcome measures for assessing OPO performance “are transparent, reliable, and enforceable; support higher donation rates; help shorten transplant wait lists; reduce discarded but viable organs; and increase safe, timely transplants that save lives.”  Key provisions of the proposed rule would:

  • Change how OPO donation and transportation rates are measured (including preventing an OPO from receiving credit for procuring an organ if it is not transplanted);
  • Require outcome measure assessments to occur at least every year; and
  • Require low performing OPOs to improve their donation and transplantation rates through a quality assurance and performance improvement program.

The rules will be published on December 23, 2019, and comments will be accepted for 60 days thereafter.