Trump administration’s new organ donation rules could force Arkansas nonprofit into decertification

November 30 - December 6, 2020

By THE DAILY RECORD STAFF 

Under new rules finalized by the Trump administration, the Arkansas Regional Organ Recovery Agency (ARORA) could be decertified or merged into another agency if it cannot improve its standing among the worst-performing organ procurement organizations (OPOs) in the U.S.

On Saturday (Nov. 21), the Centers for Medicare & Medicaid Services (CMS) announced it is finalizing the omnibus regulations designed to increase the supply of life-saving organs available for transplant in the U.S. Under a new proposal first introduced in an executive order by President Trump in July 2019, CMS has estimated the U.S. could increase the number of organs available for transplant by 5,600 per year and that the annual number of transplants performed could increase from approximately 33,000 to 41,000 by 2026. There are currently about 109,000 people on the nation’s organ donor waiting list, including 256 in ARORA’s service area.

CMS’s final rule, which is 207 pages, enacts nearly all the reforms that were part of President Donald Trump’s executive order called “Advancing American Kidney Health.” That mandate has received broad support to retool kidney care in the U.S. and hold OPOs accountable for poor performance.

Under the new CMS rules, OPOs must meet minimum quality thresholds to receive Medicare and Medicaid reimbursements that support OPOs yearly budgets. Today, OPO performance data is self-reported, which CMS officials said disincentivizes agencies from aggressively seeking to procure all available organs.

“Thousands of Americans are languishing on organ waitlists, and twenty Americans every day die waiting for an organ. This is unacceptable and the Trump Administration is acting. (This) final rule is an opportunity to improve the quality of life for millions of Americans,” CMS Administrator Seema Verma said in a statement. “Organ transplants offer hope for a fuller life untethered from dialysis machines and waiting lists. We’re helping to increase the supply of donated organs available for transplant by making sure OPOs are performing at optimal levels.”

A vital part of the U.S. organ donation system, OPOs are nonprofits responsible for evaluating and procuring organs for transplant from deceased donors. They also support donor families, clinical management of organ donors, and offer professional and public education about organ donation. There are 58 OPOs in the U.S. assigned to regional service areas in nearly all 50 states.

Known locally as ARORA, the Little Rock-based organ donation agency’s so-called donation service area (DSA) includes most of Arkansas except for several Delta counties. In recent years, ARORA has faced many legal, financial, and operational issues outside the nonprofit’s federally mandated mission of saving lives through organ donation. Among many things, those operational woes include at least a dozen high-level firings, resignations and demotions of top executives and managers, and a racial discrimination lawsuit by a former CFO who alleged a long-held culture of systemic bias and lack of promotions for black employees. ARORA’s current management team also hired a former felon as finance director in 2014. She later was fired for stealing agency funds and eventually was sent to prison in 2018.

ARORA President Alan Cochran, who was hired by the agency’s board of directors in late December 2014 after three former executives stepped down or resigned, did not respond to request for comments concerning the agency’s future. Cochran is a former tissue bank executive at Los Angeles-based OneLegacy, the nation’s largest OPO whose chief executive’s annual salary exceeds $1 million. Some U.S. lawmakers and industry critics have highlighted OneLegacy as an example of the OPOs’ current focus on profit-driven tissue harvesting over live-saving organ donation.

Steve Miller, CEO of the Association of Organ Procurement Organizations (AOPO) that represents the 58 federally designated OPOs, expressed disappointment at CMS’s final rules.

“We support independent, verifiable metrics based on valid data. We are disappointed with the final rule released by CMS. Unfortunately, the final rule fails to address most of our concerns with the flaws in the design of the new metrics, including the use of a flawed data set,” said Miller. “We look forward to working with other stakeholders to improve these metrics and ensure there is no disruption in the world’s best donation and transplantation system.”

Before last week, OPOs only had to meet minimum thresholds of two of three outcome measures: the donation rate of eligible donors and the donor yields or the actual number of procured organs donated per donor. Those measures, which CMS and critics saw did not hold OPOs accountable, were calculated using data self-reported from the 58 agencies spread across the U.S.

New standards look to weed out or improve low performers

According to the U.S. Department of Health and Human Services (HHS), CMS is replacing the existing quality measures with two new standards and implementing new performance metrics based on objective data. The first new measure is a donation rate tool based on the number of organs an OPO has procured from eligible donors in a specific DSA. That proposal also ensures OPOs pursue all potential donors, even those only able to donate one organ, CMS officials said.

The second measure no longer allows OPOs to get credit for merely procuring an organ from a deceased donor without it being transplanted, an area that ARORA has fallen short for several years, CMS data shows. The new performance scale also creates an incentive for OPOs to transplant and use all viable organs. Those donations will be measured with objective data from the Health Resources and Services Administration (HRSA) and the Centers for Disease Control (CDC), which are also part of HHS.  

Once the new rules are promulgated in nearly two years, underperforming OPOs will compete for their organizational contracts – which are necessary for them to function as OPOs. The worst performers, CMS said, will be unable to renew their contracts.

CMS also said it is making outcome measure performance public to increase transparency. The Trump administration said this would spotlight OPOs that fall outside of the top 25% in donation and transplantation rates and helps OPOs identify areas for improvement, allowing them to take timely action to save more lives. The increased accountability – to the public and to CMS alike – promises to incentivize OPOs to procure more organ transplantation organs. And by reviewing OPO performance every 12 months, federal investigators will be able to identify OPOs that need improvement quickly.

The new regulations would decertify underperforming organ donation agencies that do not take significant steps to increase Americans’ availability on the waitlist for organ transplants – about 20 deaths per day. Today, ARORA is ranked among the ten worst performers out of the nation’s 58 OPOs and would be at risk of decertification due to its failing grade, CMS data shows.

Ironically, under former President Bill Clinton, ARORA was the last OPO that HHS sought to decertify in July 2000 when the local nonprofit did not meet federal performance standards. Those rules required all organ donation agencies to meet at least 75% of the national mean in 4 of 5 categories. A federal judge eventually granted ARORA’s motion for a summary judgment against the HHS and allowed the OPO to continue to operate under a new executive team.

The Daily Record reached out to Arkansas’ all-Republican congressional delegation, which could urge the incoming Democratic administration to repeal Trump’s executive order. Sara Lasure, the spokeswoman for Sen. John Boozman, R-Arkansas, said the state’s senior senator is reviewing the CMS final rule but offered no comment on ARORA’s possible decertification.

“(Sen. Boozman) is committed to helping more individuals on the transplant list get the life-saving organs they need,” said Lasure.

Under President Trump’s new mandate, OPOs will be placed in one of three tiers at the end of each recertification cycle. According to the final proposal, the highest performing OPOs ranked in the top 25% will be assigned to Tier 1 and automatically recertified for another four years.

Tier 2 OPOs are the next highest performing OPOs, where both measures exceed the median but do not reach the highest level. This group will not automatically be recertified but will have to compete to retain their DSA. Tier 3 OPOs, which includes ARORA and seven other OPOs, are the lowest-performing organ donation agencies with one or both measures below the median. Tier 3 OPOs will be decertified and will not be able to compete for any other open DSA.”

CMS final rules will also open the service areas of lower-tier OPOs for competition. However, only Tier 1 and 2 agencies can compete to take over the service areas of poorly performing OPOs. Under the revised system, DSAs for Tier 2 OPOs could be replaced by a higher-performing OPO. In contrast, a better performing OPO will take over service territories for Tier 3 OPOs such as ARORA.

“Because OPOs have a 4-year exclusive agreement for each DSA with each recertification cycle, it is critical that we select the most capable OPO that we can find to service the area, rather than automatically recertify the incumbent OPO in Tier 2 or trying to ‘fix’ an OPO that has not been able to reach the same performance as the top-performing OPO …,” said Velma, who is likely to be replaced as CMS administrator under President-elect Joe Biden. “We believe a competition process whereby all OPOs have sufficient incentives to continue to improve will drive all OPOs to cluster near the top.”

ARORA still has time to improve its organ donation performance as the new measures will be implemented on Aug. 1, 2022, and full enforcement will begin in 2026.

[Note – Daily Record Publisher Wesley Brown submitted comments to the Federal Register in 2019 requesting CMS to include measures in its final rules on organ donation reform that clarify Freedom of Information Act requirements for organ procurement organizations.]