Arnold Ventures Submits Public Comment on Proposed Organ Donation Rule

“Nearly 115,000 Americans are currently on the waiting list for a lifesaving organ transplant, which also contributes to $34 billion annually in dialysis costs to Medicare. The problem lies with a lack of accountability in the network of government monopoly contractors charged with leading organ recoveries, called organ procurement organizations (OPOs). Research shows OPOs only recover ~35 percent of organ potential each year. To help more patients receive organ transplants, we need to move from a system where no OPO has lost a government contract in decades despite gross underperformance, to one where OPOs are held accountable. The Trump Administration pledged to move from a system of ​‘self-policing’ to one of accountability based on objective data; AV supports these efforts, and submitted a comment to the notice of proposed rulemaking.”

- Kelli Rhee, President and Chief Executive Officer, Arnold Ventures

Submitted Public Comment on Proposed Organ Donation Rule

Arnold Ventures (AV) is a philanthropic organization focused on advocating for evidence-based policy, including with a specific focus on health care. Within health care, our work aims to lower costs while ensuring access to high-quality care. 

Over the past few years, we have taken a particular interest in organ donation reform, as it presents one of the clearest opportunities to further our dual goals of improving patient outcomes while reducing health care costs. Specifically, our research has anchored on inefficiencies within the network of 58 organ procurement organizations (OPOs), the federal monopoly contractors charged with leading organ recovery efforts.

Peer-reviewed, AV-supported research from the University of Pennsylvania estimates that glaring OPO underperformance contributes to as many as 28,000 organs that are not used for transplant every year. 

The problem flows directly from a lack of accountability, including a governmental evaluation system that relies on self-interpreted and self-reported performance metric, which OPOs themselves have admitted are not reliable. That is why we have supported both President Trump’s July 2019 Executive Order, and the comments from Secretary of Health and Human Services (HHS) Alex Azar that ​“We’re going to stop looking the other way while lives are lost and hold OPOs accountable.”

As Secretary Azar also said: ​“You get what you pay for and you get what you measure and you don’t get what you don’t measure. And, right now, the system is basically one of self-policing and self-accountability.”

As such, AV supports without qualification the two OPO performance metrics proposed by CMS:

• “Donation rate, be measured as the number of actual deceased donors as a percentage of total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not be an absolute contraindication to organ donation; and 
• “Organ transplantation rate,” measured as the number of organs procured within the DSA and transplanted as a percentage of total inpatient deaths in the DSA among patients 75 years of age or younger with any cause of death that would not be an absolute contraindication to organ donation. 

AV-supported research indicates that OPO underperformance is an industry-wide problem, with OPOs, in aggregate, recovering organs from only 35% of potential donors. In large part, this results from an OPO culture of complacency, given that no OPO has lost a governmental contract in over twenty years.

Given the failure of UNOS supervision (see Senate Finance oversight letter) or previously-mandated system improvement plans to turn around OPO performance (see previous reporting on OPOs being on system improvement plans for years), enforcing decertifications is critical to meaningful accountability in patients’ interest.

As such, AV supports, without qualification, the strong performance standard proposed by CMS for OPOs to maintain contracts, which requires OPOs to maintain performance that is not statistically significantly different from the top 25 percent of OPOs in order to maintain their certifications. With 1,000 patients removed from the organ waiting list every month because they have died or become too sick to transplant, we urge CMS to enforce OPO decertifications of poor performing OPOs without delay.

We note that when recently asked about how the Administration plans to actualize the President’s promise to double the number of kidney transplants, Secretary Azar himself said: ​“You change the metrics; you hold [OPOs] accountable… if you’re going to be an OPO, you’re going to have to drive results, and if your leadership is not achieving it, you’ve got to get new leadership. And we’re going to monitor on this yearly basis and that’s going to be transparent measurements — all the world will be able to hold you accountable for delivering on these outcomes.” 

Surely that means that real accountability for government contractors must begin as soon as possible, and be enforced as strongly as possible, to ensure that patients on the waiting list receive the transplants they deserve.