Baby Miller case decided by Texas Supreme Court

One year, five months, and twenty-seven days after oral argument, the Texas Supreme Court decided the Baby Miller case today. The court, whose ranks were depleted by retirements, voted 7-0 to affirm the Court of Appeals in an opinion written by retiring Justice Craig Enoch. A few quick thoughts:

1. This is a devastating loss for the family, which has a lifetime of expensive nursing and medical care to pay for. With post-judgment interest, the judgment for the family had to have been worth over $100 million by now. The Court of Appeals reversed and rendered a take-nothing judgment, and today the Supreme Court said, "that's right."

2. The major damage done by the Court of Appeals to the Natural Death Act (now the Advance Directives Act) was technically left alone by the Supreme Court. It affirmed on other state-law grounds and said it didn't need to reach the NDA/ADA issue. But the court offered some dicta that ought to make it clear the court thought the Court of Appeals blew it, which it did (big time). So my major hope for the opinion -- that the NDA/ADA would be restored to its natural meaning -- was half-way realized.

3. The court also side-stepped the Baby Doe issue in the case. It describes the Baby Doe rule as an appropriations/funding rule, which is satisfied by the fact that Texas has CPS policies and procedures in place to respond to reports of failure to provide medically indicated treatment to infants. Period. It does not seem interested in reading Baby Doe as establishing a standard of care, at least unless CPS has been called into a case, which it was not in this case, so as far as the court is concerned: no big deal. But in any event, the court said "this is a state-law, not federal-law, case so we won't technically decide the Baby Doe issue." This is okay with me (even though I think Baby Doe does implicate state law and does establish a standard of care as a matter of state law). Anything the court could have said about Baby Doe (other than what it did say) could only have made a bad rule worse.

The really disquieting part of the decision is its reliance on the 1920 Moss case (link requires Westlaw subscription).

First of all, it's an opinion by the Texas Commission of Appeals of the Texas Supreme Court, not the Supreme Court itself; this is an oddity of Texas judicial history that makes the precedent potentially not as strong as it might otherwise be.

Second, and following from the first, the Supreme Court (in 1920) "approved the judgment in the case," which is generally regarded as weakening the precedential value of an opinion. If the court adopted the opinion of the commission, the precedential value would be higher.

Third, the holding of Moss is this: A surgeon was liable for performing surgery on a minor without the consent of the patient's parents because although "there was an absolute necessity for a prompt operation, [surgery was] not emergent in the sense that death would likely result immediately upon failure to perform it. In fact, it is not contended that any real danger would have resulted to the child had time been taken to consult the parent with reference to the operation. Therefore the operation was not justified upon the ground that an emergency existed."

Amazingly (in light of the Miller court's use of Moss), the Moss opinion ends with this: "The law wisely reposes in the parent the care and custody of the minor child, and neither a physician nor those in temporary custody of the child will be permitted, in a case of this character, to determine those matters touching its welfare." So the Miller supreme court is "guide[d]" (the court's term) to affirm the court of appeals decision against the parents on the basis of an opinion from 1920 of dubious precedential value containing a ringing endorsement of parents' prerogatives to give or withhold consent and setting a very high standard for an exception (more than "an absolute necessity for a prompt" intervention, there must be an emergency "in the sense that death would likely result immediately upon failure to perform the [intervention]." Curious.

Fourth, in Moss, the surgeon relied in good faith on the apparently valid consent of the child's aunt. He had no reason to suspect there was a lack of consent. In Miller, there was every reason to know there was no valid consent. Moss looks like a case that stands for the simple proposition that we will presume consent in a true emergency as long as there's no reason to believe consent has not or would not be given. But of what relevance is that rule to the Miller case?

Fifth, assume that Moss is good law. Does it really support this result? After all, the hospital seems to have had just about the entire day either to get the parents' consent or to get a court order to override the parents' refusal, and it did neither. I don't think Moss really says this is alright.

Curiouser and curiouser.

Big Increase Seen in People Lacking Health Insurance

Robert Pear of the New York Times has an article on the Census Bureau's report on health coverage and the uninsured. Texas's percentage of uninsured is the highest in the country (24.1%), more than triple the rate for Minnesota, the lowest (8%). Why? Here are two reasons: "Texas, facing fiscal problems and unwilling to raise taxes, cut back Medicaid and its Children's Health Insurance Program this year." Our state CHIP saga is particularly deplorable. The state left over $600 million in federal matching funds on the table because of its unwillingness to allocate money to the program. No state funds = no federal match. Details here.

New form of defensive medicine.

Modern Healthcare's Daily Dose has a short piece today about a new report from the Center for Studying Health System Change. As DD reports, "Some physicians are reacting to higher malpractice premiums by declining elective referrals, sending patients to emergency rooms and refusing on-call duty."

End-of-life care and the battle over medical proxy's right to decide.

The Boston Globe published a lengthy article in Sunday's edition about an elderly woman in a locked-in state and the attempts by Mass. General to provide palliative care only, over the objections of her daughter/surrogate decision maker.

The Times got it wrong.

An article in today's New York Times follows up on research first published last year in the medical journals Brain (abstract only; full text requires subscription) and Neurology (abstract). The gist of the research is that many "permanently unconscious" patients are in neither a coma nor a permanent vegetative state; instead, they may be experiencing some degree of consciousness:

The implications of this research, both for medical ethics and practical policy, are potentially huge. Traumatic brain injuries are a significant health problem in the United States, but the study and treatment of them are clouded with a sense of hopelessness, a feeling that consciousness is too mysterious to be understood. When faced with patients in a vegetative state, doctors can do little more than wait to see if they wake up. No treatment has ever been definitively shown to help patients recover consciousness, and doctors can't predict which patients will emerge from a vegetative state and which won't. If patients don't show signs of recovery in a few weeks, they usually wind up at home with their families or in nursing homes, and they rarely see a neurologist again. In 1976, in a famous court case, the parents of Karen Ann Quinlan, a woman who had been in a vegetative state for about a year, won the right to take her off a ventilator (after which she lived until 1985). ''There's a point where people give up'' and discontinue aggressive treatment, says Joseph J. Fins, chief of the division of medical ethics at Weill Medical College. ''The question is, Are we giving up too soon on the ones who might become more functional?'' Schiff and his colleagues say that the answer, in too many cases, may be yes.

Indeed, some of the patients may be able to recover, however fleetingly, quite remarkable levels of conscious interaction with others, through deep massage:

Giacino works hard to tease out hints of awareness in a patient. Sometimes he can actually coax patients into consciousness by working his fingers deep into their muscles. Neurologists have found that the stimulation of the nerve endings in the muscles can be powerful enough to arouse activity in networks of neurons in the brain. Giacino has a particular knack for the technique, and after a few seconds of muscle work, he can get some minimally conscious patients to speak. Some tell him their names, others tell him to leave them alone. As soon as he removes his hands, they slip away again.

Marie Conniff has seen Giacino work this transformation many times. On New Year's Day in 1998, her son Scott was on duty as a New York policeman when a drunken driver rammed his car. Today, Scott sits in a wheelchair, his gaze often drifting across the room. Sometimes he laughs, sometimes he growls like a bear. He gives hard kicks to a big orange beach ball hanging from the ceiling. When Giacino begins to work her son's muscles, Conniff finds herself startled at how well Giacino can bring Scott back, in the look on his face, the clarity of his movements. ''I see a lot of what I had before he got hurt,'' she told me.

Until now, I have been very skeptical of claims that patients in a persistent or permanent vegetative state were "disabled" patients in need of protection against discriminatory policies that give up on the disabled as if they were already dead. The accepted paradigm for PVS is that the neocortical hemisphere is, for all intents and purposes, dead. This article -- quite misleadingly -- suggest that it is quite plausible that some number of such patients, diagnosed as PVS in accordance with protocols published by the American Academy of Neurology, experience relatively high levels of functioning, some of which might be recovered through appropriate therapies. Some of researchers whose work is discussed in this article have written to The Times to dispute any such implication. (I'll provide a link when and if The Times publishes their letter.) They want to clarify that PVS is and continues to be a valid diagnosis from which there is no return to sentience.

Medicare reform.

Saul Friedman argues in today's Newsday ("GRAY MATTERS: Ideology and Meanness in Medicare Debate") that "as it now stands, any legislation that is likely to emerge based on the bills passed in June by the House and Senate would be hopelessly inadequate, too costly and too complicated for most Medicare beneficiaries. I doubt that the members of Congress who are writing it could explain it to their aging parents. More important, the legislation is a kind of pact with the devil, for the price of a paltry drug benefit is the eventual privatization and death of Medicare. In addition, the legislation would not only encourage private insurance companies to sell prescription drug coverage, the House version would help beneficiaries pay the premiums to lure them to sign up for a better deal with private insurance and desert Medicare. The intended result is the demise of Medicare, which leaves health care for the nation's elderly in the hands of dozens of private insurance and drug companies." Friedman continues:

While Medicare's opponents may take cover in ideology in the debate over these larger issues, ideology can't explain the myriad outrages buried in the 800 pages of the legislation that would cost the taxpayers unnecessary billions and pick the pockets of the sickest and oldest among us.

One extraordinary example is a provision prohibiting the government from saving money by using its buying power to negotiate volume discounts with drug companies to get the best prices on drugs for beneficiaries. Indeed, the legislation would exempt drug companies from the cost controls that govern every other Medicare provider - doctors, hospitals and laboratories.

There's more to read -- and to fume over -- in Friedman's excellent review of all that's wrong with what's going on in the Conference Committee that is trying to harmonize the House and Senate bills. I agree with Friedman: If the price tag for a prescription drug benefit we can't afford includes the ruination of the Medicare program, let's hope the conferees come up empty-handed.

When an untested drug is a patient's last chance.

An article in the Boston Globe this week explored the problems faced vby patients with terminal illnesses who have run out of drugs to help them fight their disease. In the view of some, "the current ways to get experimental drugs -- through clinical trials, 'compassionate-use' or 'expanded-access' programs -- are tragically inadequate." In response, some patients' groups are suing the FDA "to create a new level of review called Tier 1 Initial Approval. Under this plan, patients would be able to get an experimental drug if it has passed Phase I trials, if the patient has been rejected from clinical trials of the drug, and if nothing else has worked. Perhaps most controversially, they also want to allow patients to pay manufacturers for the drugs, an issue that opens a Pandora's box of ethical and liability questions." Opposition to the proposed new classification is mounting. "Nancy Roach, a director of the Marti Nelson Cancer Foundation based in Vacaville, Calif., . . . opposes the Tier 1 idea, saying, 'It would rip the heart out of clinical research.' . . . At the end of a Phase I (safety trial), a drug may have been tested in only a few dozen people. (It is not until Phase II and Phase III trials that a drug is tested in more people and researchers study dosages and efficacy.) 'You don't give drugs to people unless there's a good reason to, you know how to give them, and the person has some chance of benefiting,' she said." The widely respected physician-ethicist, Marcia Angell is also against the idea: "'New drugs are far more likely to fail than to succeed,' she said, 'so the chances are that a patient will be hurt by a drug rather than helped.' . . . She said she also is appalled that patients might end up paying manufacturers for experimental drugs. Drug companies already 'are profitable beyond any industry,' she said. 'They are protected by the government. They have monopoly rights, patents, tremendous tax breaks.' And the opposition doesn't stop there. Alan Goldhammer, associate vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, said it would be "potentially reckless" for manufacturers to release drugs after only Phase I trials because at that point there is "no proof of efficacy at all."

Boston Children's Hospital.

More cases, going back three years, not just one (the main focus of the Mass. Department of Public Health's scathing report last week), are starting to emerge. (See story in today's Pembroke Mariner.)

Children's Hospital in Boston.

With The Boston Globe's archive policy, it's hard to find the links to all of its articles about the investigations into deaths there over the past year. Here's everything I can find (with no guarantees that these links will continue to work forever):
September 18 | September 19 | September 20 | September 22 | September 23

There's a bit of a media frenzy going on, but it's a compelling story with the additional lesson that if it could happen at one of the country's best hospitals, it could happen in yours, too.

214th birthday of the Judiciary Act of 1789.

Please allow a former teacher of Civil Procedure and Federal Courts to note the anniversary of the passage of the Judiciary Act of 1789. Building on the sketchiest of language in Article III of the Constitution (which provides for "one supreme Court, and . . . such inferior Courts as the Congress may from time to time ordain and establish"), the Act gave us the District Court/Court of Appeals/Supreme Court structure we have today, though with very different functions for the lower courts. The Act also filled in the details of diversity jurisdiction; created removal jurisdiction, the predecessor of the All Writs Act, and a rule that compels discovery in actions at law to the same extent as proceedings in chancery; codified the "no adequate remedy at law" rule for equitable actions; created rules of procedure for trials and appeals; defined the (nondiscretionary) appellate jurisdiction (as opposed to the discretionary jurisdiction over writs of review) of the Supreme Court; and created the office the the United States Attorney in each federal judicial district. All of this and more can be tracked from 1787 to 1982 through the "Landmark Judicial Legislation" page of the Federal Judicial Center.

Medical error at a children's hospital

The Boston Globe has printed another good article on the recent deaths at the local children's hospital, this time focusing on the systemic, root causes (still a matter of conjecture) and considering whether there's something in the culture of teaching hospitals -- or at least some of them -- that stands in the way of effective communication, accountability, appropriate decision making, and safe system design. Important questions all.

Proposition 12: the dawning of a new day . . . .

Here's a good one from the unbeatable Ben Sargent . . . http://www.ucomics.com/bensargent/2003/09/16/

Case study of medical error in one of the best pediatric hospitals in the US.

This Boston Globe article should be required reading for anyone who is serious about addressing medical error in complex, high-quality, tertiary-care academic medical centers. "Communication and accountability problems" is the generic term for what went wrong at Children's Hospital in Boston, but the devil's in the details. For even more detail, the Massachusetts Department of Health has published a 24-page report on this and three other deaths at the hospital from August 2002 to July 2003. I haven;t found the report on the MDPH web site but I've e-mailed them about any plans they might have to post it and will provide the link as soon as I have one.

End-of-life decision making.

This week's New England Journal of Medicine published a contribution to much-needed research into the way decisions are made about life-supporting treatments. A Canadian group concluded (abstract only; full text requires subscription) on the basis of their study of 851 critically ill patients in 15 ICUs: "Rather than age or the severity of the illness and organ dysfunction, the strongest determinants of the withdrawal of ventilation in critically ill patients were the physician's perception that the patient preferred not to use life support, the physician's predictions of a low likelihood of survival in the intensive care unit and a high likelihood of poor cognitive function, and the use of inotropes or vasopressors." One problem with this approach, as Larry Schneiderman points out in an article on South Africa's Health24.com web site: "Doctors believe they know what patients want in terms of life support, and that family members can fill in blanks. But Schneiderman says his own research suggests that what physicians think critically ill people want is in fact nearer to what they would choose for themselves. Family members, too, aren't especially reliable translators of their loved one's wishes. . . . We're always relying on surrogate decision makers or physicians, Schneiderman says. But there's plenty of evidence that it doesn't correlate too well with what patients truly desire."

Does HIPAA apply to the NFL?

As we all know, HIPAA gives patients a right of access to their own medical records. Right? Right. Unless, that is, you are a professional football player, according to an article in today's Grand Forks Herald (picking up on the story originally run by the Charlotte Observer). Under the collective bargaining agreement between the NFL and the players' association, players can see their medical records twice a year -- and never during the regular season. According to the article, DHHS isn't quite sure whether HIPAA applies to the NFL (neither am I: Is the NFL a "covered entity"? It seems like a stretch). And you would think that players can contract that right away for valuable (very valuable) consideration. But Boston University's George Annas is surely right when he says, "It's so behind the times. The whole country has been moving to open access to your own records, whether they're medical, police, credit or education records. No one would argue with that anymore.

"The problem with secret records is people are making decisions about you, and you don't know why. In this case, when you're talking about professional football players, (teams) could be making decisions about whether they should play or not. Their livelihood and future health could be at stake."

Dubya takes Prop 12 on the road.

Trial lawyers, says the President in today's weekly radio address, are driving up health care costs and taking their fees away from deserving plaintiffs: "I have proposed reasonable limits on the lawsuits that are raising health care costs for everyone. . . . [And] we need to address the broader problems of frivolous litigation. We need effective legal reforms that will make sure that settlement money from class actions and other litigation goes to those harmed, and not to trial lawyers." As pointed out by AP writer Jennifer Loven (see, e.g., the San Francisco Chronicle's version of the AP story), this is a theme that Bush got mileage out of when he was governor and he has to be thinking it has a great populist ring to it for the upcoming election year.

The Safety of Imported Drugs

An editorial in today's New York Times describes the wackiness of the pharmaceutical industry's global pricing strategy. The FDA seems to be playing into that strategy with stern warnings that drug imports might be contaminated or improperly stored or transported. The FDA's position is predictable: given a choice between consumer choice and consumer safety, they will always go with safety, even when the safety concerns are more theoretical than real. (I don't mean to imply there can't be -- or aren't -- real safety concerns. The FDA has sent a warning letter to CanaRx based on that company's shipment of insulin at room temperature when the drug needs to be kept refrigerated. The real question, though, is what is an acceptable safety margin for drugs purchased at an affordable price, as opposed to drugs that are not purchased or administered properly because they are too expensive.) My hometown of Springfield, MA, is leading the way among state and local governments by pursuing an official policy of Canadian drug purchases for city employees, and Illinois is considering the same thing. Many individuals have been importing their drugs from Canada for years, despite a law that says generally only manufacturers are allowed to import drugs. As the Times editorial says, unfair pricing practices are driving this issue, and both the safety and the pricing problems can be worked out if Big Pharm and the FDA can find the desire to do so.

Another North Texas physicians' group charged with price-fixing.

The FTC has filed a complaint against yet another north Texas IPA. (See my earlier post on the last such action, in June of this year.) You can get a copy of the administrative complaint here. This IPA denies the charges of concerted refusal to deal and price-fixing by the 600-member group, which the FTC claims is not a risk-sharing entity and is neither clinically nor financially integrated.

Comfort Foods Switch Off Stress, Scientists Find

No kidding.

Really, did we need a paper in The Proceedings of the National Academy of Sciences on this to know what is now headline news in The New York Times? Here are some of the not-earth-shattering conclusions:

-- "Comfort foods like chocolate cake and ice cream literally blunt the body's response to chronic stress."

-- "This makes sense from an evolutionary viewpoint. . . . Animals that are acutely stressed stop eating, lie low and pull fat and protein from their bodies. But they cannot do that forever. . . . 'After a few days, they need to get out and get a real fix,' [the author] said. 'They need high-energy foods, like a tub of butter, to put money in the bank.' Once energy stores are replenished, a signal, probably from fat, flows back to the brain saying it is all right to calm down [and] the chronic stress cycle is turned off."

-- "'"[I]f you are overly stressed, it's probably a good idea to overeat, at least in the short run,' said [one of the authors]. 'But if you develop a thick tire of fat around your abdomen, you need to figure out a way to reduce your stress or you'll be inviting all sorts of chronic health problems.'"

-- "In an insidious sidelight, stress hormones also activate fat receptors in the abdomen and belly in ways that increase deposits of fat, he said. The more abdominal fat people have, the better they shut down chronic stress but the more vulnerable they are to diabetes, heart disease and stroke."

-- "Chronic stress, perversely, also excites the compulsive pleasure-seeking component of the system, [the author] said. 'If you use sex, drugs or rock 'n' roll instead of high-energy food to get stress-reducing pleasure, you miss out on the metabolic feedback,' he said. 'You don't shut down the chronic stress system. You just seek more cocaine. Things like saccharin won't cut it. You need the real thing or the system won't stay in balance.'"

Anyone for transcendental meditation and a pint of Häagen-Dazs?

Democrats find bright side of loss on Prop. 12

Here, in an article from the Austin American-Statesman, is a somewhat more plausible spin from the losing side of the Prop. 12 battle: Viewed as a Republicans vs. Democrats battle, getting 49% of the 1.46 million votes case was the best showing the Democrats have made in a statewide election in many years. I'm not sure how accurate it is to spin this as GOP vs. Dems, though, with top Republicans like Deborah Hankinson and Jim Baker spearheading the opposition to Prop. 12.

Prop 12 wins in a squeaker

Proposition 12 won by a 51-49 percent margin on Saturday. [See Times article here] Before the election, both sides claimed the Apocalypse was around the corner if they lost. After the election, incredibly (or predictably?) both sides declared victory.

Patients in Florida Lining Up for All That Medicare Covers

The New York Times' Gina Kolata had a great piece (link is to Tampa Tribune's on-line version; the Times link has expired) in Saturday's paper about the Medicare culture in Florida. Here's an excerpt:

Doctor visits have become a social activity in this place of palm trees and gated retirement communities. Many patients have 8, 10 or 12 specialists and visit one or more of them most days of the week. They bring their spouses and plan their days around their appointments, going out to eat or shopping while they are in the area. They know what they want; they choose specialists for every body part. And every visit, every procedure is covered by Medicare, the federal health insurance program for the elderly.


Boca Raton, researchers agree, is a case study of what happens when people are given free rein to have all the medical care they could imagine. It is also a cautionary tale, they say timely as Medicare's fate is debated in Congress for it demonstrates that what the program covers and does not cover, and how much or how little it pays, determines what goes on in a doctor's office and why it is so hard to control costs.

South Florida has all the ingredients for lavish use of medical services, health care researchers say, with its large population of affluent, educated older people and the doctors to accommodate them. As a result, Dr. Elliott Fisher, a health services researcher at Dartmouth Medical School, said, patients have more office visits, see more specialists and have more diagnostic tests than almost anywhere else in the country. Medicare spends more per person in South Florida than almost anywhere else twice as much as in Minneapolis, for example.


But there is no apparent medical benefit, Dr. Fisher said, adding, "In our research, Medicare enrollees in high intensity regions have 2 to 5 percent higher mortality rates than similar patients in the more conservative regions of the country."

Doctors say that Medicare's policies are guiding medical practice, with many making calculated decisions about whom to treat and how to care for them based on what Medicare covers, and how much it pays.

"The bottom line is that the stuff that reimburses well is easier to get done," Dr. Carl Rosenkrantz, a Boca Raton radiologist, said.

"Romer's Law" ("a bed built is a bed filled is a bed billed") predicted that demand for health care services will follow supply in Field of Dreams fashion: If you build it, they will come. This article illustrates the unsurprising corollary: If you pay for it, they will order it.

"Health care pales next to perils of eating kittens"

The only thing more attention-grabbing about an article in Saturday's Toronto Globe & Mail than its headline is its content. Here's a sampling:

Voters say the future of the health-care system is the most important issue facing Ontario. Finally, on the 11th day of the election campaign, the subject was thrust into the spotlight.

Progressive Conservative Leader Ernie Eves and his Liberal counterpart, Dalton McGuinty, yesterday devoted major addresses to the stresses and strains facing Ontario's $28-billion health system. Not that you'll hear much about it. The leaders' noble support of the sanctity of medicare got eclipsed later in the day by the Conservatives' astonishing characterization of Mr. McGuinty as an "evil reptilian kitten-eater from another planet."

And we think our debate over U.S. Medicare is a nasty one . . . .

'Do not resuscitate' instructions often ignored, overlooked

In an article in today's Boston Globe, reporter Alice Dembner relates some surprising stories and statistics about the inefficacy of DNR orders in major hospitals. Here's part of it:

Studies estimate about 20 percent of Americans have some form of "advance directive," including living wills that describe a patient's wishes and health-care proxies that designate another individual to make decisions for the patient. DNRs are written by a doctor, nurse practitioner, or physician's assistant to spell out a dying patient's decision to refuse CPR and mechanical help with breathing. When DNRs are not honored, the problem is that sometimes doctors trained to save lives disagree with the DNR decision.

"There's still a fair number of doctors around who are uncomfortable with patients being DNR," said Dr. David Clive, chairman of the ethics committee at UMass Memorial Medical Center in Worcester. "It may be for personal or religious reasons or it may be their medical opinion that the patient is not sufficiently ill to warrant the DNR order. But it's important to realize that if the patient is competent, they rule the day, not the physician."

Doctors at odds with a patient on a DNR typically try to negotiate a resolution, Clive said. But at UMass, a doctor who decides against following a patient's explicit wishes is required to transfer the patient to another doctor.

More commonly, researchers and advocates said a mistaken resuscitation of a patient happens because of a communication failure.

Many doctors are uncomfortable discussing death and they avoid asking patients what they want. Even if patients and doctors have the conversation and the doctor issues a DNR order, that order isn't automatically shared with a hospital or ambulance service.

Darned good thing the Texas State Board of Medical Examiners requires an hour of ethics instruction each year! Don't you wish your state did, too?

Fewer People on Medicare Are Dropped by H.M.O.'s

Surprising news from the Sept. 9 N.Y. Times: In an article by Robert Pear, it's reported that the "exodus of health maintenance organizations from Medicare, a trend that has alarmed elderly people and members of Congress since 1999, will slow to a trickle next year, the industry said today. . . . Karen M. Ignagni, president of the American Association of Health Plans, the lobby for H.M.O.'s and other private plans, said they would drop 39,000 Medicare beneficiaries next year." Seems the plans are expecting more relief from Congress' parsimonious reimbursement rates in the next year.

Medicare managed care (Medicare+Choice)

Excellent overview of Medicare's managed care program from United Press International: "Medicare+Choice: Failure, success, future."

EMTALA

CMS' final EMTALA rule, mentioned here last week, was published yesterday in the Federal Register.

James Rachels, medical ethicist, dead at 62.

He argued (in 1975, the year before Quinlan was decided) that "passive euthanasia" (i.e., removal of life support to allow for a patient's "natural death") was the moral equivalent of "active euthanasia" (i.e., a lethal injection of a drug with the intention of ending a patient's life). His article, originally published in the New England Journal of Medicine, is undoubtedly one of the most anthologized articles in the history of this field. The clarity of Rachel's thought and expression are a model for us all. What's missing from the obituaries and accolades from colleagues and friends, though, is this: his most famous essary pitches an idea whose time still has not come. Mainstream ethicists, as well as clinicians, judges, and legislators, do not agree that active and passive euthanasia are moral equivalents. Passive euthanasia, under at least some circumstances, is legal everywhere in the United States; active euthanasia is illegal everywhere in the U.S. But his legacy goes beyond one thought-provoking essay, and the impact of his essay goes beyond the realms of statutes and court judgments. For example, at the core of his argument is the insight that whether the conduct is called active or passive euthanasia, and whether the result is called a "natural death" or a "homicide," the removal of life-support from a patient is the cause of that person's death just as surely as a lethal injection would be. And health care professionals, family surrogates, and judges who hide behind the euphemistic notion that "they didn't cause the death, the underlying disease process caused the death," are kidding themselves. I am in favor of removing life-support from competent patients who refuse it and from incompetent patients who either made their wishes sufficiently known or clearly are not benefiting from the treatment. And I am against active euthanasia. But we owe it to the patient, as well as to future patients and to our own ethical understanding of our actions, to have the intestinal fortitude to call a killing a killing -- one justified, the other not. And that was part of James Rachels' legacy, too.

Calif. proposes ban on balance billing for ER services.

According to Modern Healthcare's Daily Dose, "California insurance regulators have filed for an emergency mandate that would prohibit hospitals from directly billing patients for emergency care that won't be fully covered by the patients' health plans. . . . The state Department of Managed Health Care contends that federal laws requiring hospitals to provide basic emergency care to all patients regardless of insurance status, combined with a state law requiring health plans to pay for emergency care regardless of whether they contract with a particular hospital, amount to an 'implied contract' between hospitals and health plans to fully cover patients' emergency-care costs." What are the chances that California, which leads the way in so many cultural trends, including some health-related ones, is establishing a model that will attract other states?

Med mal premiums and access to health care.

The normally sober and responsible GAO, the nonpartisan investigative arm of Congress, issued a report dated August 2003 entitled, "Implications of Rising Premiums on Access to Health Care." Their conclusion:

"Actions taken by health care providers in response to rising malpractice premiums have contributed to localized health care access problems in the five states reviewed [Florida, Nevada, Pennsylvania, Mississippi, and West Virginia] with reported problems. GAO confirmed instances in the five states of reduced access to hospital-based services affecting emergency surgery and newborn deliveries in scattered, often rural, areas where providers identified other long-standing factors that also affect the availability of services. Instances were not identified in the four states [California, Colorado, Minnesota, and Montana] without reported problems. In the five states with reported problems, however, GAO also determined that many of the reported provider actions were not substantiated or did not affect access to health care on a widespread basis. For example, although some physicians reported reducing certain services they consider to be high risk in terms of potential litigation, such as spinal surgeries and mammograms, GAO did not find access to these services widely affected, based on a review of Medicare data and contacts with providers that have reportedly been affected. Continuing to monitor the effect of providers’ responses to rising malpractice premiums on access to care will be essential, given the import and evolving nature of this issue.

"Physicians reportedly practice defensive medicine in certain clinical situations, thereby contributing to health care costs; however, the overall prevalence and costs of such practices have not been reliably measured. Studies designed to measure physicians’ defensive medicine practices examined physician behavior in specific clinical situations, such as treating elderly Medicare patients with certain heart conditions. Given their limited scope, the study results cannot be generalized to estimate the extent and cost of defensive medicine practices across the health care system.

"Limited available data indicate that growth in malpractice premiums and claims payments has been slower in states that enacted tort reform laws that include certain caps on noneconomic damages. For example, between 2001 and 2002, average premiums for three physician specialties—general surgery, internal medicine, and obstetrics/gynecology—grew by about 10 percent in states with caps on noneconomic damages of $250,000, compared to about 29 percent in states with limited reforms. GAO could not determine the extent to which differences in premiums and claims payments across states were caused by tort reform laws or other factors that influence such differences.

"In commenting on a draft of this report, three independent reviewers with expertise on malpractice-related issues generally concurred with the report findings, while the American Medical Association (AMA) commented that the scope of work was not sufficient to support the finding that rising malpractice premiums have not contributed to widespread health care access problems. While GAO disagrees with AMA’s point of view, the report was revised to better clarify the methods and scope of work for this issue."

The beat goes on . . . .

Proposition 12: Does Texas need a constitutional amendment to limit noneconomic damages?

Prompted by a friend and former student/research assistant, I venture a couple of opinions about the current vote on Proposition 12, which would amend the Texas constitution to authorize the Lege to limit the ability of courts to order judgments based upon large noneconomic damages (such as pain and suffering).

1. As has been reported widely, including last Sunday in the Fort Worth Startlegram, doctors are lobbying patients with posters in their offices, brochures at the sign-in desk, inserts in the mailed bills to their homes, and jawboning during office visits. As the AMA Ethics Code rightly points out (AMA Opinion 9.012), doctors don't lose their first amendment rights when they become licensed. But they have to do so "with the utmost sensitivity to patients' vulnerability and desire for privacy." A careful and discreet physician would at least heed the warning of the Connecticut State Medical Society: "Political conversations are a fundamental part of political freedom. They must be, however, undertaken with great care in order that they do not interfere with the physician-patient relationship, exploit the medical authority of the physician or impose upon vulnerable patients or family members. Physicians should use common sense in deciding on the time and place for the exercise of their political rights." Different people will draw the line in different places, but I favor a more restrictive approach within the existing rule that would avoid political proselytizing within the office (unless the subject is raised by the patient, signalling her comfort level with the discussion), and I'd even extend that to inserts that accompany the bill. For a defense of such an approach, check out the comments of medical ethicist and religious studies professor M. Therese Lysaught.

2. On the merits, Prop. 12 seems both reckless and unnecessary. Unnecessary because HB 4 already limits noneconomic damages in med mal cases, adding Texas to the minority of states to have done so. A recent report from the federal Government Accounting Office (mentioned in this blawg on August 3) has given us plenty of reason to believe that this law won't solve or even particularly address the insurance crisis in Texas, but no one is seriously questioning the constitutionality of HB 4. Doctors who say a vote for Prop. 12 is a vote for your physician are being just a little disingenuous. They got their fix from the 78th Legislature. This isn't about them any more, other than to provide a constitutional "fix" for the inevitable (but, I predict, unsuccessful) constitutional challenge that will be mounted against HB 4. The constitutional arguments are not strong ones, and they've mostly been rehearsed in the courts the last time the Legislature enacted tort reform for health care claims. Reckless because it opens the door to wholesale legislative revision of the tort system and the checks and balances that have worked for a very long time in this state to keep all kinds of businesses and merchants in line. As between the two major groups waging war over this -- Save Texas Courts vs. Yes on 12 -- STC (consisting of a coalition headed by former Supreme Court Justices Deborah Hankinson and James Baker -- neither one known to be partial to the plaintiffs' bar or law-reform groups like the ACLU) seems to have the better arguments, which to one degree or another have been endorsed by every major newspaper editorial board in the state, as well as Texas AARP, MADD, and the ACLU.

Final EMTALA rule due in next Tuesday's Federal Register.

The NY Times reports in a Sept. 3 article that the final EMTALA rule will be published in next Tuesday's Federal Register. Correspondent Robert Pear says the rules lighten the burden on hospitals and physicians. DHHS' fact sheet is here, and the text of the final rule is here.

Rationing Medicare.

Theresa Agovino writes in an Associated Press article that Medicare is prepared to approve a price of $55,000 for an implantable left ventricular assist device (LVAD) that costs hospitals $150-200,000. Most hospitals will be reluctant to cover the shortfall from other operating revenues. But if Medicare paid full price for the device and if there were enough devices to meet the demand, the price tag could top $15-20 billion a year. All this for a device that gives the average patient an average of 8.5 months of life after it is implanted and a 23% chance of surviving 2 years (compared to an 8% chance for those treated medically). All of this foretells a looming problem:

HeartMate's evolution illustrates the nexus of a health care system beset by an aging population, rising costs and limited resources and the longing for lifesaving technology often made by companies seeking to maximize profits. The conflict is expected to become more heated as more expensive technologies and procedures are developed, and at least in their infancy are not overwhelmingly effective. It will be especially difficult for Medicare, facing the baby boomer retirement wave and already searching for a way to finance a prescription drug benefit.

"Technology is being created faster than our ability to put in any kind of a financial, ethical and moral framework," said Dr. Allen Korn, chief medical officer of the Blue Cross and Blue Shield Association, which issued a report saying the device qualified for reimbursement.

"Nobody wants to hear they are going to die. But somewhere there needs to be a bottom line," Korn said.

Adds Art Caplan, chairman of the department of medical ethics at the University of Pennsylvania's medical school, "We are headed for a big political debate about rationing health care - a debate no one wants to have."

Welcome to the tip of the rationing iceberg . . . .