HHS Releases Proposed Rules to Help Americans Waiting for Transplants

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Toward the end of last year, the United States Department of Health and Human Services (HHS) issued several proposed rules, including one by the Centers for Medicare and Medicaid Services (CMS) to change the way organ procurement organizations (OPOs) are held accountable for their performance. The proposed rule, along with a proposed rule by the Health Resources and Services Administration (HRSA) to remove financial barriers to living organ donation, comes in response to a July 2019 Executive Order on Advancing American Kidney Health.

OPO Proposed Rule

Currently, an OPO’s performance is measured via self-reported data that was last revised in 2006. CMS is proposing changes to the measurement of OPO performance to increase accountability and incentivize them to actively collect organs and improve transplantation rates in their donation service area (DSA).

CMS is proposing the following:

  • That 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;
  • That 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;
  • That all OPOs meet the donation and transplantation rates of the current top 25 percent of OPOs, which would be made public; and
  • 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.

The proposed rule would improve the current measures by using objective and reliable data and if all OPOs were to meet both the donation and transplantation rate measures, the number of annual transplants would increase by almost 15,000 by 2026.

Most of the changes outlined in the proposal would not take effect until 2022; however, CMS plans to plan the outcome measures public during the next four-year recertification cycle for OPOs once the rule is finalized.

Removing Financial Disincentives to Organ Donation

The President’s Executive Order on Advancing American Kidney Health emphasized that supporting living organ donors can help address the current demand for kidney transplants. 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. The proposal by HRSA 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.

National Kidney Foundation Response

The National Kidney Foundation released a statement supportive of the two proposed measures, “Today the Administration announced two new proposed rules to address the critical organ supply crisis in America by expanding reimbursable expenses for living donors, establishing quality metrics for Organ Procurement Organizations (OPOs) and increasing the supply of transplantable deceased donor kidneys; and the National Kidney Foundation applauds these efforts to help the nearly 95,000 Americans waiting on a life-saving kidney transplant.”

Administration Response

“Our broken system of procuring organs and supporting kidney donors’ costs thousands of American lives each year,” said HHS Secretary Alex Azar. “President Trump sees kidney disease as a health challenge where we can make a major impact, and his Advancing American Kidney Health initiative, including today’s announcements, will transform the lives of American kidney patients, who have been neglected for too long. Many organ procurement organizations do wonderful work, but some aren’t performing nearly as well as they could. We’re going to stop looking the other way while lives are lost and hold OPOs accountable. On living donations, we’re going to dramatically expand support for living kidney donors, so that Americans who wish to be generous living donors don’t face unnecessary financial barriers to doing so.”

“Every day, twenty Americans die waiting for an organ and thousands of Americans are languishing on waitlists. That is unacceptable and represents a missed opportunity to save lives and improve patients’ quality of life,” said CMS Administrator Seema Verma. “Under President Trump’s leadership, CMS is tackling this longstanding issue in the health care system by proposing decisive action to raise performance standards for organ procurement organizations and incentivizing them to facilitate transplant of as many viable organs as they can. We are modernizing the organ transplant system so our sickest patients can receive the care they need. An imperfect organ is better than no organ at all. For someone on a waitlist, that may mean the difference between life and death.”

“Living organ donation is an important option for thousands of people on the national transplant waiting list,” said HRSA Administrator Tom Engels. “To date, approximately 96,000 individuals are on the national waiting list awaiting an available kidney. This proposed rule will increase living organ donation by removing financial disincentives for living organ donors.”

 

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