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There are more than 250,000 people in the U.S. at the end stages of heart failure. Of those about 15% are in critical need of a heart transplant. The Centers for Medicare and Medicaid Services (CMS) tightly regulates organ transplant programs and can halt reimbursement if they find a program falling short of their standards. Denial of reimbursement by CMS essentially shuts the door for many candidates who have endured an interminable period awaiting their chance for a new life.

The likelihood of patient survival weighs heavily on transplant centers in the U.S. Programs are constantly aware of the importance of keeping their survival rates at or above national medians. “We are only judged on the numbers, on the results,” said a heart transplant surgeon at a hospital in the Northeast, who requested anonymity to avoid jeopardizing future job opportunities. “My main job is to treat percentages, not patients.”

A recent study by the American College of Surgeons on organ transplant centers found that the sickest patients are removed from their waiting lists because of concerns that a negative outcome could harm their ratings and lead to federal scrutiny.

Harold Miller, President and CEO of the Center for Health Care Quality and Payment Reform, said “you may decide not to take patients who are at risk of bad outcomes if somebody’s going to start rating you on your outcomes without adjusting properly for their [condition]. Those are the patients that need the hospitals the most, and they are the ones that are going to potentially get disadvantaged by this.”

In addition to the likelihood of survival criterion, there is another metric that focuses on the period following surgery.

Transplant programs are measured by how many patients survive for 365 days after their heart transplant. That survival rate, among other indicators, determines whether a program will be renewed by CMS. This rule was put in place in 2007 following an extensive review of transplant centers that showed gross inadequacies in patient outcomes.

It’s worth noting that approximately 85 to 90 percent of heart transplant patients are living one year after their surgery, with an annual death rate of approximately 4 percent thereafter.

Nevertheless, a 365-day red line results in many surgeons strongly encouraging patients and families to reconsider do not resuscitate directives (DNR) after the transplant surgery. During a heart transplant operation, a patient cannot have a DNR order in place. The new heart may need to be shocked or stimulated with chest compressions to help it function properly. These actions would be considered “resuscitation.”

However, let’s assume the surgery itself was a success. Families are then confronted with medical staff who are reluctant to relinquish the option of resuscitation. “The 365-day problem is real, and if you gave truth serum to every transplant doctor in America, including me, and you asked if we didn’t all keep an eye on it, and if we said we didn’t, that would be a lie,” said Dr. David Weill, a consultant to transplant programs and former director of the heart-lung transplant program at Stanford University Medical Center. As the one-year anniversary approaches, Weill added, he’s seen doctors tell patients, “‘It’s too early [for a DNR], I’ve seen people recover, she has a strong will to live, these kinds of things.”

So, is this ethical? Should physicians discourage a DNR when both the patient and family have specifically stated that a DNR is their final directive? Do physicians already know that the patient’s chances of survival after resuscitation are negligible but are only looking to surpass that 365-day window? Such a struggle is spelled out in in a current and real-live scenario.

Without transplant programs, people will die. Effective November 29, 2019, the Trump administration passed a rule that modifies some of the requirements placed on centers. This step surprised many transplant physicians who have long called for relaxed federal oversight.

“I don’t want anything to in any way imply that I’m a fan of the current administration,” Jesse Schold, a researcher at the Cleveland Clinic said…“however, in this case, I think it is something that is beneficial…” such changes would be a “significant net positive” for patients.

Predictably, some argued this would be a setback to the standards that have improved several transplant centers’ performance, likening it to the bad old days. But is such an objection an example of the “perfect being the enemy of the good?”

The right of self-determination/autonomy is an overriding bioethical principle that drives the purpose for advance directives. In order to apply this principle, a patient and family need honest and straightforward communication to assure informed consent.

If a patient wants a DNR, is it ethical for physicians to discourage a DNR by providing false hopes to patients and families? No, it is not ethical.

Does the “end” of keeping a transplant center open justify the “means” of keeping a patient with a DNR alive to meet the 365-day threshold? To whom does the physician owe a duty of loyalty? The patient or the transplant center?

I ask, why are patients, families, and physicians wallowing in this quagmire? It is because of the rules. Not only do some rules with “unintended consequences” compromise patients’ rights but they also compromise the integrity of physicians who work diligently to save lives. I say change the rules…and trust [our physicians] but verify.

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