Medical Futility and the Sarkisyan case: not the post you will expect

I propose to talk about Nataline Sarkisyan and the concept of medical futility.

Emotions are running so high over this particular case that I feel compelled to begin with the following:

CIGNA sucks. It is a health care disaster, and even without the Sarkisyan case provides the corporate post-child for a government takeover of health care. Consider the following:

1. CIGNA has been targeted by the Attorney General's Office in New York for passing of a list of physicians who keep costs down as a list of quality health care providers.

2. CIGNA has been tagged in a multi-million dollar class-action suit by care providers it stiffed for payments over a multi-year basis, and is sooo guilty that it is offering a huge settlement to get out from under.

3. There are actually far worse cases in CIGNA's past than the Sarkisyan affair. Consider Bland vs Cigna Healthcare of Texas, which Dr. Thaddeus Pope characterizes thus:

Basically, Bland, a terminally ill AIDS patient was dependent upon a ventilator. Both Bland and his family insisted that he remain on the ventilator. But apparently at the direction of the Cigna medical director and without consulting Bland, his family, or the primary care physician, the chair of the ethics committee secretly and unilaterally ordered the ventilator removed.

This is only a small part of the disgusting CIGNA story, but that's not why I am writing.

The Sarkisyan case has been presented quite sensationally in the media, with headline-grabbing high-profile litigator Mark Geragos doing what ambulance chasers do: throwing around a lot of rhetoric such as his attempt to have the decision-maker at CIGNA charged with homicide. A knowledgeable former prosecutor, according to the Washington Post, dismisses this call as posturing:

Geragos' attempt to get the district attorney to press murder and manslaughter charges against Cigna would be difficult to prove unless the defense can show that the company somehow intentionally caused Nataline's death, said Rebecca Lonergan, a law professor at the University of Southern California.

"My personal opinion is that this is a little bit of grandstanding," said Lonergan, a former Los Angeles County and federal prosecutor.

What has been lost in this story is the very real issue of medical futility, or the question of whether or not "heroic" and costly procedures should be continued well after the consensus of medical professionals is that such actions are no longer going to have positive results.

Sarkisyan, for example, had already received a bone marrow transplant, and although her attending physicians rated her as having a 65% chance of surviving at least six months with a new liver, their opinion was not without other highly trained physicians who disagreed. It is always difficult to find doctors who will second-guess other doctors in public, but again the Washington Post reports:

One of Nataline's doctors, Robert Venick, declined to comment on her case. UCLA Medical Center staff refused to make her other doctors available for comment.

The case raised the question among at least one medical expert over whether a liver transplant is a viable option for a leukemia patient because of the immune-system-suppressing medication such patients must take to prevent organ rejection.

Such medication, while preserving the transplanted liver, could make the cancer worse.

Transplantation is not an option for leukemia patients because the immunosuppressant drugs "tend to increase the risk and growth of any tumors," said Dr. Stuart Knechtle, who heads the liver transplant program at the University of Wisconsin at Madison and was not commenting specifically on Nataline's case.

The procedure "would be futile," he said.

Dr Thaddeus Pope, Assistant Professor of Law at the University of Memphis, who tracks such cases on his Medical Futility blog, conducted a very careful examination of the available public record, and despite being no CIGNA admirer, concludes,

While highly controversial, based on the press reports, Cigna's decision to deny coverage for Nataline Sarkisyan's liver transplant appears to comply with the relevant rules. Cigna consulted available practice guidelines. And it sought and obtained independent external review.

Medical futility is a difficult subject that no health care organization--even a single-payer system like Medicare--can avoid.

Here's the New York Times in 2003 regarding a vexing issue for Medicare about lung transplants for the elderly:

The federal Medicare program is expected to decide this week whether to pay for an aggressive and expensive lung operation that could offer a lifeline to tens of thousands of elderly patients.

But health economists and medical experts say the treatment, however alluring, is part of an unsettling trend: new and ever pricier treatments for common medical conditions that are part and parcel of aging -- procedures that could potentially benefit tens of thousands of patients, at a total cost that would far exceed the kind of prescription drug benefit now being considered by Congress.

The questions, these experts say, are how much Medicare can or should pay, and whether cost-effectiveness should enter into the decisions.

The procedure under consideration this week is an operation for people with severe emphysema, whose lungs are so scarred that they are constantly out of breath. In keeping with its policies, the government's Center for Medicare and Medicaid Services has consulted with medical experts and professional societies and says it expects to issue its decision as early as tomorrow.

The story of the operation, health economists say, is a case study of the troubling and thorny questions that Medicare administrators face as they try to live within the constraints of the $267.8 billion-a-year federal program.

Medical blog the Happy Hospitalist suggests that, for a start,

Make futile care determinations legally binding.

Withdrawal of support in futile situations would not be a legal basis for a lawsuit. Refusal to escalate care could not be a basis for a lawsuit. If you want all care all the time, we will end up with no care, all the time.

Unmanaged expectations are bankrupting our system.

But Medical Futility points out that this is a thorny question:

I agree with the HH that eliminating futile treatments would save a significant amount of health care resources. Indeed, the savings would allow costs and thus premiums to drop, expanding access. Indeed, there is a consensus within the medical community that futile care determinations should be legally binding. But a futile care determination is not a futile care determination is not a futile care determination. The real challenge of the last decade has been and continues to be how to operationalize this principle. WHICH futile care determinations should be legally binding? What attributes must they exhibit?

Complicating the issue is that so many medical futility cases involve organ transplants. The policies and protocols that govern the various foundations and non-profit organizations that, in cooperation with major transplant centers, control the allocation of available organs and the waiting lists are incredibly complex.

(One of the questions I have not found an answer to in the general press coverage of the Sarkisyan case is, who got the liver that she had originally been allocated? Somebody did, and presumably it saved their life. Do we value that life any less?)

I have a very good friend who has handled organ procurement for a major public Virginia hospital for more than a decade. I'll call my friend Jamie, which is as gender neutral a name as I can come up with. Jamie has spoken to me at length about the dynamics involved in the whole process that don't get written down. I cannot verify this information from any other source, although it rings true to me, and I cannot provide you with Jamie's real name for obvious reasons. So as you read what follows, please attribute to it only as much credibility as you would give any anonymous posting from "somebody on the inside" who fears retaliation for speaking out. I believe that Jamie is stating the truth as he/she sees it, but that doesn't mean his/her perspective is absolutely accurate.

That having been said, first here's what Jamie says about transplant centers in general:

Hospitals with transplant centers have to do a lot of transplants in order to keep the best docs, to pay for the best equipment, and to keep getting research grants. That means we compete with other transplant centers to get organs. I'm not saying we do transplants for patients who don't need them, but we fight hard to get organs sent to our facility rather than anywhere else.

There are actually strategies for insuring that a high number of organs come to your transplant center.

Jamie:

We do three things. First, we argue the patient's case (assuming the tissue match is good enough). There are two ways you can argue a patient's case. You can either argue for the greatest need--they'll die next week if they don't get this kidney--or you can argue best prognosis--this person will have a better chance of surviving the procedure and having good odds of five-year survival. We argue whichever case stands the best chance of getting us the organ; sometimes it is pretty cynical.

Then we argue the quality of our docs and our center over everybody else's. If you send a liver somewhere and the patient doesn't survive the procedure or the organ is damaged in the transplant, then the organ is lost to everybody. We always argue that, if all other factors are equal, that we have the best docs and the best chance of a successful outcome. When we can tie a specific doc's expertise and track record to a specific kind of transplant, we do really well.

Then we argue all the 'extras.' How we'll go get the organ anywhere, provide instant interface with the hospital where the organ is being harvested. You work hard to build a personal relationship with the people who run the organ lists, so that they'll view you sympathetically.

Jamie also points out that whether or not insurance pays for the procedure is NOT necessarily a defining issue:

We need the volume of transplants almost more than we need the insurance companies to pay for them. It's like sometimes we write off the actual cost of the operation against keeping up our volume and keeping ourselves competitive for grant money. Actually, I don't think this is bad for patients. I can't remember a case where we let one of our patients go without an organ because the insurance company wouldn't pay for it. Besides, I work just as hard to maintain our relationship with them as I do with the transplant networks.

This portion of Jamie's comments, at least, I can verify via Medical Futility, which notes of the Sarkisyan case:

The family's lawyer, Mark Geragos, has promised a civil suit as well as a criminal investigation. But why focus on only Cigna? If the liver transplant was medically necessary, why did UCLA make the payment issue dispositive? It looks like the famous Wickline case, also from California. There, because the payer refused further coverage, the physicians discharged the patient early contrary to their own medical recommendations. The oft-cited opinion in that case suggests that in such situations both the payor and the provider might be liable.

My point in all this is not (I say again NOT) to let CIGNA off the hook or to make a case for or against either the current health care system or a potential single-payer system. From what I can glean from the experts this is one of the issues that doesn't go away no matter what system you are working under (Medical Futility, for example, documents similar cases in Australia).

The most recent posting on Medical Futility, "The Futility Treatment: Who Decides?" cuts right to the chase:

The problem is that, in practice, pure process approaches are still vulnerable to the same criticism that Cannold levies against the old definitional approach: "And as doctors are generally the sole arbiters of medical probability" . . . this "amounts to saying to families, 'Your values don't count.'" This may be a consequence that is acceptable. But it certainly remains a very real consequence.

My secondary motivation for this extended post is to make the case as objectively as possible that these health care issues are extremely complex, and require careful rather than sensational deliberation.

I think this is true regardless of your position on the political spectrum.