The United States had a once-in-a-generation opportunity to save countless additional lives each year by enacting smart reform of the federal regulations that govern organ donation and transplantation. Unfortunately, final federal regulations the Trump administration published late Friday squandered that opportunity.
As the Centers for Medicare and Medicaid Services was undertaking a revision of its operational rules and corresponding metrics, U.S. donation and transplant professionals urged it to realign last-century methods now used by key components of the organ donation and transplant system with 21st-century innovations.
CMS had the opportunity to ensure that its reforms took into account that organ donation and transplantation is a complex system of interdependent processes executed between multiple medical organizations and medical professionals. It also had the opportunity to create new regulations that reflected the best ideas of medical experts across the nation.
Yet the regulations announced on Friday ignored advice and experience-based wisdom from the donation and transplant community. They instead promulgated punitive and counterproductive regulations that will lead the world’s best organ donation transplant system into significant uncertainty and chaos.
Organ donation and transplantation requires a three-part system: the hospitals where donors die; the transplant centers where recipients receive donors’ organs; and the organ procurement organizations (OPOs) that coordinate the process. These three entities should be incentivized to work together to make transplants happen and advance transplant innovation. Regulations should facilitate and align these entities to drive real improvement for patients.
The stated goal of the regulations is to increase rates of organ donation and transplantation in the U.S. by changing the metrics for assessing the national network of 58 organ procurement organizations. These organizations work with families to authorize donations, coordinate recovery, safely transfer organs to transplant centers, and support successful transplants. Specifically, the metrics seek to increase the number of deceased donors who become actual donors, and to increase the number of their organs that are made available for transplant.
The intent of the new regulations is laudable and fully supported by donation and transplant professionals. But their execution will not achieve their aims.
CMS has singled out only organ procurement organizations without considering corresponding reforms to the other codependent parts of the system. The new metrics take a narrow and punitive view of ensuring accountability that seems determined to close up to half of organ procurement organizations over eight years. They threaten to dismantle the collaboration that is required in an interconnected system that people have relied on for 40 years to give and receive the gift of life.
For instance, the regulations do not require donor hospitals to maintain on life support patients with non-survivable brain injuries long enough to make sure their viable organs can be considered for donation. But CMS will grade organ procurement organizations as underperforming if the donor hospitals in their service areas — over which they have no control — remove such patients from ventilator support before the hospital notifies the organ procurement organization or a donation discussion can be had with next of kin. The new regulations also rank organ procurement organizations by measuring their ability to get donated organs transplanted, even though transplant surgeons — not OPOs — decide what organs can be used for their patients.
Under the new regulations, organ procurement organizations that do not meet CMS’s flawed metrics — based on death certificate data that often inaccurately record the cause and circumstances of death rather than on patient medical records, as the transplant community has recommended — will face closure, leaving gaping holes in the system.
CMS offers assurance that other organ procurement organizations will be allowed to compete to service the area of decertified organ procurement organizations, leaving no part of the country without vital organ donation and transplant coordination. But CMS has failed to address the significant regulatory disincentives for organ procurement organizations to do this. It also fails to offer a plan for what happens if organ procurement organizations do not step forward to “compete” within a network that was intentionally designed to maximize collaboration and ensure that the highly delicate processes of coordinating deceased donation are free of a competitive and transactional mindset.
Inexplicably, the CMS rule grades organ procurement organizations on a curve. Rather than establishing a high bar for outcomes and incentivizing all organ procurement organizations to meet or exceed it, the rule evaluates each one against the performance of those organizations judged to be in the top 25%. This will result in situations where well-performing organ procurement organizations with multiple year-over-year improvements could nonetheless face closure if they do not fall into the arbitrary 25% category.
The new regulations will bring chaos. More than half of the nation’s organ procurement organizations will be kept in a constant state of uncertainty, tracking a goal post that moves continually based on the performance of others, rather than being fixed to an objective standard. This will only serve to destabilize the system and harm the very people it is supposed to serve.
A limited scope and the prospect of harsh penalties for even well-performing organizations may seem enticing to regulators, but it misses entirely the system-wide approach needed to build upon the strengths of our current highly effective organ donation system and to aid people in need of transplantation. These strengths have included expanding the system of using organs from donors who die after ventilator withdrawal (known as donation after circulatory death) and from individuals who are medically complex, such as those with hepatitis. Both circumstances have required organ procurement organizations and transplant programs to coordinate changes in practices. These collaborative changes have resulted in continual system-wide performance improvement, with year-over-year increases in deceased donation and transplants for nine consecutive years, resulting in a decrease in the wait list for the first time in decades that began in 2015 and has continued to decline ever since.
Over the last few months, as Covid-19 has affected all facets of the health care system, including transplantation, we have learned the critical importance of system-wide collaboration, cooperation, and innovation among hospitals, organ procurement organizations, and transplant centers. It would have been wise to extend those lessons and integrate them into effective system-wide reform.
Here’s an example of a systems-based approach that actually works: Early in the Covid-19 pandemic, last-century processes were still the rule for organ transplantation. Intensive care units across the country were treating dying patients infected with a virus that made them ineligible to be organ donors. Yet as required by federal rules, hospital staff members still had to refer these patients to their regional organ procurement organizations. Instead of using their valuable time to treat critically ill patients, ICU professionals and others spent hundreds of hours transmitting information by telephone that was then typed into a computer by someone on the other end of the line. This is the same way hospitals have sent information to organ procurement organizations since the 1970s.
Before Covid-19 struck, Yale New Haven Hospital, where I work as a transplant surgeon, had just begun to implement a new approach to referring potential donors that could be a useful model for the entire transplant network. The pilot program, begun in March as a collaboration with our local organ procurement organization, New England Donor Services, harnessed electronic medical record technology to automatically push data about potential organ donors into the donor referral system instead of conveying this information by phone. Not only did it free staff members to treat patients, it also made it possible to transmit 100% of required donation referrals accurately and on time with patient-level data provided electronically in real time to the organ procurement organization. This automated process was accomplished through Yale’s electronic health record at very little cost.
This approach assured that every potential organ donor was properly identified in a timely way to maintain the possibility of lifesaving donation and transplant through the entirety of the Covid-19 surge that swept through our hospital. This kind of inter-organizational quality improvement represents what innovation looks like, but was ignored by the new CMS regulations. Such an innovative approach across the system would have the additional benefit of providing accurate data for CMS to calculate real donation performance based on medical records rather than using unreliable death certificate data.
The U.S. transplant system is the world’s best across all transplantable organs, outpacing the donation rate in Europe by nearly twofold and registering nine consecutive years of increases in deceased organ donation. Yet even as the seamless electronic referral of potential donors has proven effective in pilot projects at Yale and elsewhere around the country and has held out the potential of significantly better data, the new CMS regulations remain silent about such improvements and sidestep incentivizing innovation.
Here are two other innovations not addressed by the CMS regulations that can increase donation: One is promoting the use of mechanical devices to keep donated organs viable for longer periods of time. The other is providing reimbursement incentives for transplant centers to accept more of the organs that organ procurement organizations are able to recover, rather than rejecting organs that are medically more complex and costly to transplant. While this may sound risky, many European countries successfully transplant organs from donors whose health or age at death render them untransplantable in the America. A current U.S. impediment to using more organs is that the costs of transplanting marginal but still usable organs are much greater than transplanting more ideal organs, but they are reimbursed at the same rate as ideal organs, and the expectations for outcomes are the same.
Forward-looking regulatory changes could have helped both donation and transplantation grow and improve. Instead, the new regulations are a step backward. For instance, testing innovative devices for use in donation and transplantation requires testing them using donated organs that are not suitable for transplant but prove vital for research. The new regulations refuse to recognize such research organs as “donor organs.” This leaves the families who made the decision to donate an organ for research wondering why their loved ones’ contributions to advancing the field do not count in the eyes of the government.
The donation professionals who work with these families to make the most of donors’ gifts are integral and dedicated to the transplant process, and do not deserve to be treated as representatives of uncaring monopolies by our government. As a transplant surgeon, I have worked alongside these professionals for decades and am grateful for the care and compassion they give to donors and their families, not just at the time of death but for decades to follow. They have been at the forefront of innovation and improvements in this field and fully support further reforms.
It is incumbent upon the incoming Biden administration to fix the misguided regulatory folly that is the new CMS rule. I urge the new administration to move quickly to once again instill scientific rigor and trust in experts and their expertise as we continue improving our already world-leading donation and transplant system.
David C. Mulligan is a transplant surgeon at Yale New Haven Hospital, chair of the Division of Transplantation and Immunology at Yale School of Medicine, president of the boards of directors of the Organ Procurement and Transplantation Network and the United Network for Organ Sharing, and volunteer member of the clinical advisory board for New England Donor Services.