Bioethics Forum Essay

U.S. Organ Donation Needs Better Oversight, but New Rule Will Not Help

If you have read an article about organ donation in the United States, you may know that more than 100,000 people in this country are waiting for a life-saving transplant and on average 30 people die each day while waiting. But you might not know that the nonprofit organizations responsible for coordinating organ transplants between donors and recipients– organ procurement organizations (OPOs)–could be doing more to lower these numbers. Oversight of OPOs has been minimal, meaning some OPOs have not done their best to make sure that possible donors become actual donors and that organ donations become organ transplants. A new government proposal designed to more closely regulate OPOs could, in some respects, actually make the situation worse.

Organ transplants don’t just happen. They require a coordinated system for identifying potential organ donors, communicating with donor families, screening for eligibility, identifying compatible recipients in the highest priority category, and ensuring the smooth transport of donor organs to transplant centers where recipients are located. OPOs are the contractor organizations responsible for the lion’s share of this work across the U.S. Since 2006, Centers for Medicaid and Medicare (CMS) regulations have required all 58 OPOs to realize a high number of organ donations and transplants based on eligible donors. CMS can survey OPOs and then either recertify or decertify them based on their performance. The baseline for performance–number of eligible donors in a service area– has been self-reported by each OPO, and no OPO has ever been decertified. But is this a sign of over-achievement on the part of OPOs, or under-regulation by CMS?

Improving OPO performance could significantly reduce the number of people waiting for, and dying without, organ transplants. The number of OPO-reported eligible donors has not correlated well with other examinations of potential organ supply, indicating that not all OPOs are doing their job well. In 2019, an executive order was passed calling on CMS to revise its oversight process and hold OPOs more accountable in part by establishing better outcome metrics. This year, CMS promulgated a new final rule establishing, among other things, that death certificate data drawn from a database of the Centers for Disease Control and Prevention would be used to determine the number of eligible donors. While attractive as a “readily and publicly available” resource for estimating donor potential, using death certificate data to measure actual donor potential is dangerously flawed.

Death certificate data do not uniformly reflect conditions that would preclude donation, such as ventilation, sepsis, or cancer. A death certificate that declares the cause of death as “blunt force trauma due to car accident” would not also specify disseminated intravascular coagulation – blood clots throughout the body affecting organ perfusion. Another that says cause of death is “complications of opioid toxicity” would miss HIV positive status or other donation exclusion criteria. The latter is particularly concerning in light of the extraordinary increase in overdose deaths in recent years. This means eligible deaths could be grossly inflated. Moreover, many death certificates contain significant errors regarding causes of death to such a degree that several medical examiners and coroners have voiced concerns over death certificate use to determine organ donation eligibility. We cannot even rely on death certificate data to accurately reflect contributing causes of death.

When attempting to fix a problem, it is unethical to choose a broken tool out of convenience when better tools exist. CMS requires that when patients at a hospital meet specific clinical triggers, hospital staff must make timely referrals to its OPO of potentially eligible donors. Some hospitals are now electronically sending this information to OPOs with the push of a button. Others are automatically sending this information–an algorithm determines when the clinical triggers are met and releases the data to the OPO without the push of a button. CMS could outline exactly the clinical criteria for donor eligibility and these data could be sent directly from hospitals to OPOs and to CMS simultaneously. Automatic and electronic referral pilot data demonstrate significant improvements in ensuring potential donors become actual donors. Such systems will need continued piloting and oversight to ensure data protection, objectivity, consistency, and reliability. It might not get more objective, efficient, and transparent than this.     

Even OPOs agree that OPOs need to be held accountable. There is no question that the system and its oversight should be improved to increase organ donation and save more lives.  But using such a flawed metric as death certificate data to determine the OPO performance denominator would not accurately track where improvements need to be made. Ineffective and misguided reform efforts would follow, perhaps leading to the decertification of OPOs that actually perform well. Ironically, this would only exacerbate the problem CMS set out to fix in the first place.

Brendan Parent, JD, is director of Transplant Ethics and Policy Research and an assistant professor of bioethics and surgery at NYU Grossman School of Medicine, @parent_brendan. Alexander T.M. Cheung, MBHL, is a medical student at NYU Grossman School of Medicine, @alexorscanner.