Proposed Federal Rules Could Increase Nation’s Organ Supply

By Jonathan Springston, Editor, Relias Media

The Trump administration this week proposed two rules designed to increase the nation’s organ supply, kidneys in particular, and improve accountability for organ procurement organizations (OPOs).

More than 100,000 Americans are on waitlists to receive an organ transplant; 20 of these die every day. Many patients on waitlists need new kidneys. In response, President Trump signed the Executive Order on Advancing American Kidney Health in July, directing federal agencies to act on this issue, and laying the groundwork for this week’s rule proposals.

“CMS is tackling this longstanding issue in the healthcare system by proposing decisive action to raise performance standards for [OPOs] and incentivizing them to facilitate transplant of as many viable organs as they can,” Centers for Medicare & Medicaid (CMS) Administrator Seema Verma said in a statement. “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.”

An OPO serves as a bridge between organ donors and recipients, securing organs from hospitals and delivering them to transplant centers. CMS periodically surveys OPOs to ensure those organizations are meeting quality and safety standards. Currently, these standards are measured through self-reported data based on metrics last overhauled in 2006. CMS’ proposals would seek to make OPOs more accountable and incentivize these organizations to collect more organs and improve transplantation rates.

“Many [OPOs] 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,” Health and Human Services Secretary (HHS) Alex Azar said in a statement. “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.”

CMS estimates that if the proposed rules become law, OPOs could increase the number of annual transplants from 32,000 to 37,000 by 2026. The Association of Organ Procurement Organizations (AOPO), which represents the 58 federally designated OPOs, welcomed the CMS proposals.

“An independent, verifiable metric for evaluating OPO performance can be an important tool, helping to identify potential opportunities for growth, in OPOs’ quest for continual improvement,” AOPO President Kelly Ranum said in a statement. “We look forward to working with CMS on implementation of the rule and ensuring the metric is used to drive the changes everyone in the donation and transplantation community wants to see.”

The National Kidney Foundation (NKF) also expressed optimism about the federal proposals and eagerness to work with the administration. “One of the proposed rules announced today will expand financial assistance to living donors under the National Living Donor Assistance Center {NLDAC) to include reimbursing lost wages for donors who take time off from their jobs for donation and recovery and for childcare and eldercare expenses,” the group said in a statement. “These changes will help ensure living donors are made financially whole after giving the gift of life; however, increasing the available pool of resources under NLDAC is critical to ensuring its success and to increasing the pool of living donors.”

Earlier this month, the Organ Procurement and Transplantation Network (OPTN), part of HHS, approved a measure that will take effect in 2020 that is designed to improve and expand kidney and pancreas distribution. Today, most of these organs are delivered to candidates listed at hospitals within the same donation service area (DSA) where the donor hospital is located. OPTN notes these DSAs are “fixed, often irregular geographic boundaries” that do not optimize organ allocation.

Under the newly approved OPTN rule, these organs will be offered first to candidates listed at transplant hospitals within 250 nautical miles of the donor hospital. Offers not accepted for any of these candidates will then be made for candidates beyond the 250 nautical mile distance.

Some transplant decisions result in legal cases invoking constitutional clauses. Patients may take cases to court because they were denied due to failure to abstain from drinking, incarceration, or age discrimination. The December 2019 issue of Medical Ethics Advisor includes an article about a recent paper that analyzed judicial review of these controversial cases.

“The risk of a constitutional claim highlights concrete steps needed to ensure the equity of transplant policy,” the authors wrote. “These include efforts to standardize transplant candidacy criteria across payers for candidates with alcohol-related liver disease and advanced age.”

The upcoming January 2020 issue of Medical Ethics Advisor includes a report about the ethics of allowing organ procurement from unrepresented patients. While this is a common practice in many U.S. states, it raises questions about justice and whether a “presumed consent” donation model would be more ethical. The article includes interviews with researchers who explain the practice and attempt to unpack the problems associated with this difficult subject.