Combatting Inappropriate EOL with the False Claims Act

Many providers claim that some EOL care that surrogates demand they provide to patients is inappropriate. It is inappropriate because it provides no benefit to the patient. Or worse, it actually harms the patient. If this is right, then it seems that such care ought not be billed to Medicare. It is not medically necessary care.

Medicare knows, the CBO knows, and everyone else knows that Medicare willo have to start using some more aggressive CBA to ration the treatments that it covers. But even before we get to that, it seems that even under current regulations, Medicare should not be paying for much EOL care.

One way that this determination might be made is through the prosecution of a False Claims Act Claim. This could be brought (in New Jersey where there is comparatively more inappropriate EOL care) by the U.S. Attorney, the state AG, or even a private qui tam plaintiff like a nurse who observes too much inappropriate care.

Yes, I know that using the FCA in this way is very controversial. It brings in federal statutes to regulate the quality of medical care, something that state tort law is supposed to do. Worse, it could put providers in a real bind. If they refuse surrogate-demanded care, they may have state tort exposure. If they provide the demanded care and bill for it, they may have FCA exposure. Nevertheless, some FCA theories can be litigated in some egregious outlier cases.

Combatting Inappropriate EOL with CON

The Dartmouth Atlas concluded that the most powerful preductor of inpatient death was bed supply. Therefore, it is likely that New Jersey's excess bed supply is the reason that NJ patients receive more EOL care than patients elsewhere.

So framed, this overutilization problem is not unique to the EOL context. It's not inextricably linked to issues of informed consent or life and death. It's not really a bioethics issue but rather a more mainstream regulatory issue. This is what Certificates of Need are meant to address.

The basic assumption underlying CON regulation is that excess capacity (in the form of facility overbuilding) directly results in health care price inflation. When a hospital cannot fill its beds, fixed costs must be met through higher charges for the beds that are used. Bigger institutions have bigger costs, so CON supporters say it makes sense to limit facilities to building only enough capacity to meet actual needs.

We know that health care markets do not operate like other markets. If you build it, they will come, and Medicare will be billed. According to the NCSL, NJ does have CON statutes or regulations in effect. I'll have to look more closely to understand the excess bed situation.

The Future of EOL Bioethics

Monday's conference, A Troubling Abundance of Care: Overtreatment at the End of Life, was worthwhile. The primary impetus for the conference is the Dartmouth Atlas' finding that NJ EOL care is the most expensive in the nation. My primary complaint was anticipated near the end of the day: "This is preachig to the choir." The organizers are planning another conference for the Fall to focus on practical implementation and translation into policy.

Art Caplan keynoted the conference in the morning with some reasons why were are in a mess:

1. Schiavo created uncertainty
2. Big, big expenditures (like Avastin)
3. The failure of living wills
4. Other new EOL technologies

He identifies some wrong moves in EOL policy:

1. Futility (since there is no definition)
2. Living wills
3. Expanded organ procurement (like the NYC organ ambulance)
4. The American Society of Clinical Oncology's suggestion to raise cost issues with patients (since that will not cause anyone to limit costs)
5. Attacking brain death (since the concept is not in play)

Art finally offered some positive suggestions:

1. Reaffirm the right to control
2. EOL care not just in the ICU bust also in primary care
3. Emphasize DPAHC
4. Address fears of prescribing addictive drugs
5. No ANH exceptionalism
6. No starting EOL treatment without knowing when will stop
7. Get all the team on board the treatment plan (including the weekend nurse)
8. Do not offer false hope
9. Always offer your professional opinion (while bioethics has done a "bad thing" by making medical care too autonomy-focused and option laden, do not just offer up a "restaurant menu")

Good suggestions. But I wonder whether they are enough. Even with better communication and stronger endorsement and persuasion of "appropriate" treatment, many surrogates will continue to press for "inappropriate" treatment. We can perhaps reduce the scope of those sorts of conflicts, but nothing in Art's suggestions will eliminate them.

Medical Futility CME Video

The Affinity Health System is an integrated health care network in rural Wisconsin comprised of 23 clinics and three hospitals. Last year, Affinity started a video blog of its CME programming.

On Friday, the topic was Medical Futility. It was apparently offered as part of th EPEC curriculum (Education in Palliative and End-of-Life Care).

Here is the video presentation by Dr. Linda Blust.

Do the Right Thing -- Even at the Risk of Getting Sued

Dr. Dinosaur recognizes, today, that one of the leading reasons that physicians provide care that they know is inappropriate is because they cannot convince the surrogates otherwise. "I can't [fail to provide futile care]! I might get sued!" His response: "Yes. You might. So what? Heresy alert: being sued is not the end of the world."

The risk of being sued is low, as I demonstrate here. Cases are rarely brought where the probability of success is low and/or the damages are low. But the probability is not zero. Moreover, private foundations sometimes fund these lawsuits just to "send a message."

I admire Dr. Dinosaur's gumption for standing up for what he thinks is right and best for his patients. But I strongly suspect his encouragement to other physicians will fall on deaf ears. Physicians are extraordinarily risk averse. They want more than low risk, they want a guarantee of immunity. While such guarantees are perhaps coming down the pike, they are, as yet, not generally available.

"Nudge" toward Better EOL Care

The medical literature is replete with learned commentary about the unique status of CPR as the one medical intervention that patient must consent NOT to have. And the literature is replete with studies of the extremely limited effectiveness of CPR for certain patient populations. For certain patient populations, DNR is widely perceived to be socially desirable in terms of avoiding patient suffering, avoiding staff distress, and saving resources. But physicians are unwilling to seek consent to DNR orders. And patients and surrogates are unwilling to give consent. They do not want to confront death.

Dr. Dinosaur suggested, this week, that the default presumption in favor of CPR be reversed for some frail populations. Accordingly, providers would not need to get consent for or enter a DNR order. All these patients are already DNR – unless, perhaps, they opt out.

I like the idea of reversing the presumption here, just as here in Delaware we are seeking to presume consent to donate organs unless you opt out. This idea of changing the baseline has a strong conceptual and economic basis in a new and popular book, Nudge: Improving Decisions about Health, Wealth, and Happiness (Yale University 2008). In Nudge, Cass Sunstein and Richard Thaler argue that since we are such irrational creatures highly susceptible to predictable biases and errors, we need to be “nudged” in socially desirable directions. Nudging is (allegedly) consistent with libertarian ideals because the individual is free to engage in whatever conduct that she desires (full code, no organ donation). No choice is restricted. The choices are just presented in such a way that laziness and inertia (failure to make a choice) will result in the socially optimal choice.

Troubling Abundance of Care: Over-treatment at the End of Life

The New Jersey Star-Ledger reports about a conference I'll be attending on Monday.

New Jersey's intensive use of medical care at the end of life -- the most aggressive in the nation -- will be examined at a day-long medical conference Monday at Richard Stockton College of New Jersey.

Physicians, ethicists and other experts in end-of-life care will discuss ways to bring more compassion and candor to medical care so patients will avoid treatments that do not prolong life or improve the quality of life.

The conference is titled "A Troubling Abundance of Care: Over-treatment at the End of Life." The title refers to a December three-part series in The Star-Ledger that examined over-treatment of dying patients. The series noted that the Dartmouth Atlas of Health Care found that patients in New Jersey see more physicians and specialists, get more tests and procedures, and are more likely to die in the hospital than patients anywhere else in nation.

Yet experts said these patients do not live any longer or have improved quality of life because of the extra treatment.

Dartmouth researcher David Goodman and other educators, physicians, lawyers and theologians are to discuss ways to change the culture that leads to overtreatment. Star-Ledger medical reporter Carol Ann Campbell, who wrote the series, will also participate.

Stockton College President Herman Saatkamp, a biomedical ethicist, will welcome participants to the conference, which is sponsored by the Southern Jersey Ethics Alliance and other organizations. The keynote speaker will be Arthur Caplan, chairman of the University of Pennsylvania Center for Bioethics. Experts from the University of Pennsylvania, Rutgers University, the University of Medicine and Dentistry of New Jersey, Stockton College and several medical systems will talk about ways to improve end of life care in New Jersey.

Additional information is at http://www.stockton.edu/hshs.

Stop It, Right Now!!!

Dr. Dinosaur has some strong words, today, for ER docs and hospitalists: "just (don't) do it." Reminds me of the title of a medical journal article: "Don't Just Do Something, Stand There."

Some practitioners are quite confident of their ability to predict on admission who will not leave the hospital alive. They *know* some patients won't make it.

Nevertheless, these same practitioners “proceed to hook these patients up to nine IV pumps.” They proceed to “torture [these patients] to death scheduled for surgeries and other endless treatments.” They “go ahead and intubate; start the pressors; call the ICU.”

Dr. Dinosaur urges practitioners to refuse inappropriate requests, to “step up to the plate and do something about it, by not doing what shouldn't be done in the first place.” “Don't tube that demented old granny. Explain to the family why it's not appropriate to put dad in the ICU. . . . When faced with a terminal patient (and yes, we all know dementia is terminal; why can't we face that?) just don't do it.”

I agree with Dinosaur that “managing the problem of futile care is important (and . . . becoming critical).” But he does underplay some of the reasons that providers continue to give care they themselves deem inappropriate. First, while 40+ states may have statutory language providing legal protection for unilaterally refusing life-sustaining treatment, that protection is practically illusory given the vagueness of those statutes. Second, Dinosaur’s definition of unacceptable treatment is controversial. Just because someone will not leave the hospital alive does not necessarily mean that they can derive no benefit from prolonged life in the hospital. The classic case, of course, is the request for extra time to see the family member imminently arriving from abroad.

Slow Medicine

A primary cause of futility disputes is the fact that "many in their 80s and 90s — and their boomer children — want to pull out all the stops to stay alive, and doctors get paid for doing a procedure, not discussing whether it should be done."

An article by Jane Gross in this morning's New York Times describes a different group of patients and physicians.

Charley Gieg, 86 at the time, was suffering from a heart problem, an intestinal disorder and the early stages of Alzheimer’s disease when doctors suspected he also had throat cancer. A specialist outlined what he was facing: biopsies, anesthesia, surgery, radiation or chemotherapy. Ms. Gieg doubted he had the resilience to bounce back. She worried, instead, that such treatments would accelerate his downward trajectory, ushering in a prolonged period of decline and dependence. This is what the Giegs said they feared even more than dying, what some call “death by intensive care.”

"Slow medicine" shares with hospice care the goal of comfort rather than cure. Grounded in research at the Dartmouth Medical School, "slow medicine encourages physicians to put on the brakes when considering care that may have high risks and limited rewards for the elderly." And it educates patients and families "how to push back against emergency room trips and hospitalizations designed for those with treatable illnesses, not the inevitable erosion of advanced age."

While slow medicine "is increasingly available in nursing homes . . . for those living at home or in assisted living, a medical scare usually prompts a call to 911, with little opportunity to choose otherwise."

Martin v. Memorial Hermann (Part II)

The commenter on my previous post about Martin v. Memorial Hermann is correct in most respects. There is nothing blameworthy about the hospital's plan to utilize the Texas Advance Directives Act. It was designed as a mechanism to resolve intractable futility disputes. However, it is unclear whether this dispute truly was intractable because it is unclear what sort of communication and mediation occurred before any plan to use TADA 166.046. It is also unclear whether the MH ethics committee would have agreed with the treatment team. Still, even had the formal mechanism been employed, presumably the same transfer that was made would have been found and made.

The commenter is also correct that there is nothing wrong with trying to get the parents to voluntarily terminate LSMT. The problem is that their efforts may have moved from persuasion to manipulation or coercion, such that any consent would not have been truly voluntary. Again, we have a very incomplete set of facts here.

The providers at Memorial Hermann were absolutely correct in not automatically acceding to any treatment request that Sabrina's parents made for her. If they felt that the requested treatment was "medically inappropriate" or "medically unacceptable," then they certainly should (1) try to convince the parents of that, (2) find another decision maker, or (3) find another provider. They apparently tried all three of these, ultimately using (3) to resolve the dispute.

I have requested but have not yet seen the complaint. However, I do not think, as the commenter suggests, that the parents are suing for over-treatment or wrongful life that left them with a severly brain-damaged child. Rather, it appears they are suing for under-treatment or mistreatment that led to the bad outcome in the first place.

New Futility Case: Martin v. Memorial Hermann

Chris Vogel has a lengthy and detailed story in Thursday's Houston Press, titled "Doctors vs. Parents: Who Decides Right to Life?" It describes a compelling and serious futility dispute that is now headed to court.

14-year-old Sabrina Martin's surgery for a sinus infection did not turn out well. She developed a brain abscess and brain swelling. The staff at Children's Memorial Hermann Hospital told Sabrina's parents that Sabrina "had two strokes and because of them, she was in a coma that they didn't think she was going to come out of. And if she did, she would be a vegetable." The staff then "began pressuring them to withhold treatment and feeding."

But they allegedly went far beyond just trying to persuade the parents what they thought was the best course of action. In addition the Memorial Hermann staff:

• Attempt[ed] to turn relatives and friends against Lopez and Murray by encouraging them to persuade the parents to withhold treatment, all the while violating federal privacy laws by discussing Sabrina's healthcare information
• Enter[ed] two separate do-not-resuscitate orders against her parents' wishes
• Threaten[ed] the family with convening the hospital's ethics committee, which under Texas law can overrule the family's wishes and withhold life-support treatment from a patient.

But most serious of all is the allegation that “Memorial Hermann and the doctors and nurses working on the case wanted Sabrina to die to bury the evidence of malpractice and limit the potential damages in court.”

Perspective from the ED

Over at EM Physician, a new ED attending gives some job advice to docs looking for a job as a senior resident:

Be honest with yourself. You should choose a job/location that (honestly) appeals to you.

We all know that many of the worst societal problems are recurring themes in the ER. The location of the ED will determine which of these 'societal problems' predominate your practice. I don't mind the drunks, the dumb assess who crash their bikes/cars, the assaults. I enjoy working with people of color, and am not at all intimidated by loud obnoxious men under the influence cursing and yelling. But . . . The barrage of demented, essentially dead, nursing home patients who should be allowed to die with dignity...but instead their family insists that everything be done (eventhough it's our *responsibility* to refrain from participating in futile care), annoy me. "

The "Irreversible" is Reversible After All

Yesterday, the Boston Globe reported the recovery of Haleigh Poutre, a 14-year-old girl once diagnosed as being in an "irreversible vegetative state." Haleigh was almost removed from life support by Masachussets DSS after doctors had declared her condition hopeless. She began to breathe on her own just as the state's highest court ruled that she should be allowed to die.

More recently, Haleigh has "provided police with dramatic testimony about frequent use of corporal punishment during her childhood." Haleigh, who has "spent the last two years at a pediatric rehabilitation hospital in Brighton, communicated with simple words and hand gestures in an interview last December. She also spelled out full sentences by pointing to letters of the alphabet on a board."

This is obviously a remarkable recovery for Haleigh. And it may ensure that the parties culpable for her injuries are held criminally responsible. But the downside of this story is that it s publicity may undercut public trust in diagnoses. If we use terms "irreversible vegetative state" with respect to patients who recover, surrogates may be less willing to accept diagnoses and recommendations to stop LSMT. Their patient may be another Haleigh Poutre. I readily concede that diagnoses can almost never be made with 100% certainty. My point is that in our use of language, we ought not imply certainty where none exists.

Keeping Granny Alive for the Money

There are many reasons that patients and surrogates request life-sustaining medical treatment that providers deem inappropriate. They may be hoping for a miracle or compelled by religious rules. They may be mistrustful that the diagnosis is really that dire. But sometimes it is for the money. Over at the Estate Planning Blog, NJ attorney Henna Shaw recommends that people demand any and every medical intervention to keep them alive until 2010, when the tax laws change.

Ms. Shaw observes that "under the current estate tax structure, the federal estate tax exemption amount is $2 million in 2008, $3.5 million in 2009, and there is no federal estate tax in 2010." Therefore, she suggests "counseling clients to include . . . language in their current health care directives instructing that they be kept alive by any means necessary until January 1, 2010 (or maybe a few days later, just to be safe). This would effectively permit a client to achieve maximum estate tax savings, assuming the client might otherwise pass away before 2010."

Ms. Shaw gives this example: "Assume we have a single client with a taxable estate of approximately $13.5 million. If that client were to get into a fatal car accident on December 1, 2009, her estate would be subject to an estate tax of approximately $4.5 million. If the client could be kept alive until January 1, 2010, however, there would be no estate tax, and her beneficiaries would inherit the entire $13.5 million."

I am not sure what the IRS would make of this. But this could potentially create a whole bunch of futility disputes. Agents and surrogates may be particularly motivated to honor the patient's wishes since they will be the beneficiaries of any tax breaks. But health care providers may be particularly unwilling to maintain a patient's low-quality, zero-quality, or negative-quality corporeal existence merely to avoid taxes.

Doctor - Patient "Matching" to Avoid Conflicts

In her forthcoming book, Conflicts of Conscience in Health Care: An Institutional Compromise (MIT 2008), Holly Fernandez Lynch suggests that patient-provider conflicts can be eliminated or minimized through patient-doctor matching. Here is the publisher's abstract:

Physicians in the United States who refuse to perform a variety of legally permissible medical services because of their own moral objections are often protected by "conscience clauses." These laws, on the books in nearly every state since the legalization of abortion by Roe v. Wade, shield physicians and other health professionals from such potential consequences of refusal as liability and dismissal. While some praise conscience clauses as protecting important freedoms, opponents, concerned with patient access to care, argue that professional refusals should be tolerated only when they are based on valid medical grounds. In Conflicts of Conscience in Health Care, Holly Fernandez Lynch finds a way around the polarizing rhetoric associated with this issue by proposing a compromise that protects both a patient’s access to care and a physician’s ability to refuse. This focus on compromise is crucial, as new uses of medical technology expand the controversy beyond abortion and contraception to reach an increasing number of doctors and patients.

Lynch argues that doctor-patient matching on the basis of personal moral values would eliminate, or at least minimize, many conflicts of conscience, and suggests that state licensing boards facilitate this goal. Licensing boards would be responsible for balancing the interests of doctors and patients by ensuring a sufficient number of willing physicians such that no physician's refusal leaves a patient entirely without access to desired medical services. This proposed solution, Lynch argues, accommodates patients' freedoms while leaving important room in the profession for individuals who find some of the capabilities of medical technology to be ethically objectionable.

I look forward to reading Lynch's book. But at least in the futility context, Lynch's proposal may meet with very limited success. The basis for provider refusal is not idiosyncratic but widespread. Therefore, there may be insufficient providers available to match with surrogates who demand the use of all available technology. Indeed, the opportunity to transfer mechanism is a sort of post hoc matching mechanism. And it often fails to produce a match.

Futility and Limb Salvage

While most discussion regarding medical futility disputes centers around life-sustaining medical treatment, many other types of interventions may be medically inappropriate for the same or similar reasons. The stakes simply are not as high. For example, in the April 2008 issue of the American Surgeon, Spence Taylor discusses the "Current Status of Heroic Limb Salvage for Critical Limb Ischemia."

He notes that "critical limb ischemia ios a manifestation of systemic disease. As our population has aged we have learned that limb salvage surgery does little to thwart the ravages of spiraling poor health." The "original measure of procedural success, reconstruction patency, is a poor eventual predictor of functional outcome." Many patients (e.g. those with impaired ambulation, end-state renal disease) "might be better served with a primary amputation an no attempt at revascularization."

Therefore, Taylor argues, we must "redefine our goals of therapy to cost-effectively maximize the palliative benefit to the patient." Indeed, Taylor suspects that this redefinition may be "imposed by third party payers as our patient volume increases and our health care system continues to financially falter."

Futility in Florida

John Dorschner has this short piece in this morning's Miami Herald, titled "Doctors, family may be at odds over treatment: Some states -- but not Florida -- have so-called futility laws, in which providers are not required to give care which they believe is futile."

When a person nears the end of life, how much treatment should she or he get -- and who should decide?

''These are huge questions that go to the very core of healthcare,'' says Ken Goodman, director of the bioethics program at the University of Miami.

While the Dartmouth Atlas research emphasizes how the number of physician specialists in a locale will increase the amount of care, even in the last six months of life, Goodman focuses more often on the conflicts of desires between providers and family members.

''Even when everybody knows the dying process has begun, families routinely request very aggressive medical treatment that nobody believes is going to work,'' said Goodman.

''You want to work with families. You want to respect their grief, but there is a duty to be a responsible steward of resources, to act in the patient's best interest. and to be true to your profession,'' he said.

Some states such as Texas, but not Florida, have so-called futility laws, says Goodman, in which providers are not required to give care which they believe is futile.

Many people believe in medical miracles because they often see them on TV, says Goodman. He cites a study of television programs like ER in which heroic measures almost always bring a patient back to life.

``It's not that simple. What if you break some bones pounding on the heart to get it going again?

''What if a patient lives, but it's only for another six weeks and they're not conscious,'' Goodman said.

He describes the increasing interest in hospice programs as a ``beautiful example of a nonpartisan, nonsectarian agreement to pass away pain-free and with dignity.''

Still, ''what often happens,'' Goodman said, ``is that family members ask for a therapeutic frenzy.'

Conscience and Gags

With the end of classes, I am catching up on some reading. I just read this article from the February 8, 2007 New England Journal of Medicine. Curlin et al. show that "14% of patients -- more than 40 million Americans may be cared for by physicians who do not believe they are obligated to disclose information about medically available treatments they consider objectionable."

I find this troubling. While futility policies (and laws) are aimed at enabling providers to avoid providing treatment they deem ethically or professionally inappropriate, those policies and laws always inform the patient/surrogate and allow the opportunity to transfer. The objective is to allow specific providers to decline to provide some treatments, not to altogether prohibit the patient from getting the treatment. The objective is to allow providers to extricate themselves from the administration of interventions.

But Curlin et al.'s study suggests that many physicians' refusals look more like evangelism or proselytism. They never even mention some alternatives (even life-preserving or life-sustaining alternatives). Therefore, these physicians' patients/surrogates do not even know to look for a transfer or to seek review.

Misdiagnosing PVS

Several people have recently urged me to consider studies demonstrating the error rates in diagnosing PVS. While I have yet to do so, I did notice this appellate opinion published yesterday in Wisconsin, and briefly reported by the Chicago Tribune.

In 2000, Tywanda Luckett suffered permanent severe brain damage allegedly due to medical malpractice. In a damages action brought in 2003, one of the defendants asked the plaintiffs to admit that Tywanda was in a PVS and that the PVS was permanent. Plaintiffs made those admissions. Presumably both treating physicians and/or retained experts had reached this conclusion. Notably, plaintiff's counsel made the admissions knowing that they would substantially reduce the value of the case both for the plaintiffs and for himself.

In preparing for trial, plaintiffs' counsel found doctor's notes stating that, in 2001, Tywanda could "follow simply commands," "comprehend some of what is said to her," and is "aware" and "responsive." Since such evidence strongly suggests that Tywanda was not in PVS, counsel sought to withdraw the admission. The trial court allowed this and the appellate court affirmed, even though Tywanda is now deceased and defendants cannot examine her. Consequently, the value of the case has now changed dramatically with the addition of five years of pain and suffering damages.

Legal Clarity in Australia vs. Uncertainty in USA

Brendan Murphy, CEO of Austin Health in Melbourne, has some strong words in this personal perspective piece in the April 7th issue of the Medical Journal of Australia. Murphy asks, "What has happened to clinical leadership in futile care discussions?"

"[S]taff at all levels across the hospital sector believe that they are actively treating a proportion of patients for whom such treatment is clearly futile." They should not pursue this course of action "even if apparently desired by the next of kin." Most surrogates "will accept a decision to withhold futile treatment, as long as they are not being asked (as is commonly the case) to personally make what they see as a life-ending decision."

Murphy observes that no court in the U.K. or Australia has ever "overturned a carefully considered decision by a doctor to withhold treatment that is considered futile." So, in the rare cases where mediation fails, Murphy welcomes legal challenges as "an objective endorsement of actions to support the primary duty of care to the patient."

In contrast to the United States, Murphy states that the problem in Australia is not "an issue that requires legislative change or widespread community debate." Rather, the challenge there is to get medical leadership groups to influence medical education and practice to get clinicians to do their best by their patients.