Medical futility.

Today's Allentown (Pa.) Morning Call has a long, well-written article on medical futility. The author, Ann Wlazelek notes that

a national turnabout in medical ethics, one in which doctors no longer want to employ all that medical science has to offer to keep patients alive and families find themselves fighting for their loved ones' right to live.

It's a shift in thinking that evolved in the past decade from the realization that it may be more humane to comfort than to try to cure patients near the end of life.

Backed by court orders and medical ethicists, hospitals have adopted little-known policies that declare ''doctors know best'' in deciding when to withhold or withdraw potentially life-saving treatments. As a result, a patient's final wishes may not be carried out, even when dictated in a living will or other legal document.

''Years ago, it was the physician who wouldn't stop. Now, it's the opposite: The doctor wants to give up and the family doesn't,'' said Dr. Joseph Vincent, an internist and founding member and chairman of the medical ethics committee at Lehigh Valley Hospital.

Most times, doctors and families concur about end-of-life treatments such as resuscitation, ventilators and feeding tubes. But when they don't, relations can get nasty. Relatives who persist in their protest can find themselves confronted by security guards, out-of-pocket medical bills and court petitions for guardianship.

The turnabout has taken place over the past 10 years. Patients began losing trust in their physicians when health maintenance organizations paid doctors to restrict access to expensive specialists and tests. Also, studies proved the most advanced technology and medicines cannot always keep patients alive but can cause them harm. The example cited most often is the risk of breaking ribs or causing nerve damage when performing chest compressions during CPR.

The article discusses a hospital policy adopted at Lehigh Valley Hospital-Muhlenberg:

"If all of these steps are taken and the family remains unconvinced, neither the doctor nor the hospital are required to provide care that is not medically indicated, and the family may seek a substitute physican (if one can be found) and another hospital (if available). The Lehigh Valley Hospital will assist the family in their efforts to find those substitutes."

Stephen E. Lammers, a professor of religious studies at Lafayette College, said he helped Vincent draft LVH's guidelines as "a way of signaling to everyone that the insistence upon continued treatment went beyond accepted medical practice."

The difficulty with the guidelines is illustrated by the article's discussion of a heart-attack victim as to whom continued aggressive treatment was thought to be futile by the attending physicians, nurses, technicians, social workers, and a chaplain. Despite the hospital's policy, aggressive therapy was continued until the day the patient was transferred to another facility; she died the following day.

Under LVH's guidelines, when the family and medical staff cannot reach consensus, one of four things can happen: The medical staff concedes to the family's wishes and continues to treat aggressively; care is transferred to another doctor or medical facility, as in the Jandras case; a local judge or court is consulted; or the doctor refuses to treat the patient.

Vincent said the last option to refuse treatment ''takes courage'' on the part of the physician because he or she will most likely be sued. No doctor at LVH has refused to treat a patient, he said, but some patients have been transferred to other facilities.

The Lehigh Valley problem -- the dark cloud of legal liability -- has been addressed in Texas. Under the Texas Health & Safety Code § 166.046, a physician, other health care professional, or hospital that refuses treatment deemed not to be beneficial to the patient, including "futile" care, is immune from criminal liability, civil liability, or professional discipline, as long as all of the elements of the law's "due process" provisions are followed, include a mandatory ethics committee consultation and reasonable attempts to transfer the patient to another provider or facility if the family and health care team continue to be at an impasse.

The mandatory ethics consultation is a unique feature of the Texas law that was the first of its kind in the country and, to my knowledge, remains the only one. The newspaper article addresses the potential utility of ethics consultations:

Despite the shift in medical ethics, many relatives resolve their differences with doctors at LVH through the hospital ethics committee.

One satisfied consumer, Erica Robbins of West Chester, said the committee eased tension between a doctor and the family regarding her elderly aunt's need for a breathing machine and related surgery.

The specialist initially had told Robbins he would not recommend putting 91-year-old Olga Katz of Bethlehem on a ventilator because she had congestive heart failure and probably would not survive her hospital stay.

"I felt insulted that someone who had just met her 20 minutes earlier would make a decision about what she wanted," Robbins said.

At the same time, she didn't want to make the decision on her own, so Robbins and her family consulted two rabbis and researched Jewish law in Israel. The law said ventilate.

Robbins lauded the ethics committee for allowing her, her husband and sister-in-law to speak about Katz as the vibrant person and Holocaust survivor that she was. Katz eventually left the hospital, Robbins said, and lived another six months.

This vignette illustrates another often misunderstood feature of hospital ethics committees: Any committee worth its salt will be just as open to the family in a futility dispute as to the treatment team, and when the case for "futility" just hasn't been made, ethics committees will recommend continued treatment.

The full article covers many important points and is well worth checking out.

Redefining parenthood.

Michael Douglas' ex-wife, Diandra, moves in with Zack Hamton Bacon III, a New York hedge-fund executive. When they try to have kids by IVF and failed, they tried a surrogate, and that failed, as well. (It's unclear whether the IVF attempts and the surrogacy attempt are the result of an infertility problem with one of the prospective parents or is simply a matter of preference. Both Diandra and Zack are parents of children from their previous marriages.) They engage the services of another surrogate in Southern California, where Diandra lives when she's not in NYC. The surrogate gets pregnant through IVF with a donated oocyte. In fact, she's carrying twins, who are born about 3 months early.

Diandra and Zack are now splitting. She's filed for custody in California. He's filed in Manhattan for an order that would force Diandra to bring the children to New York. If the case stays in California, is Diandra -- who is neither the genetic mother nor the gestational mother -- the mother of the boys and therefore entitled to assert parental rights? Students in this summer's Bioethics and Law course know the answer, courtesy of Johnson v. Calvert and Buzzanca v. Buzzanca. For everyone else, here's the end of today's article in the N.Y. Times:

If the case stays in California, the fact that Ms. Douglas is not the biological or genetic mother of the twins is unlikely to make a difference, because case law here emphasizes intent when deciding who is a legal parent, said Leslie Ellen Shear, an Encino lawyer who has been involved in many surrogacy cases.

Surrogacy, unmarried parents, relocation issues, allegations of domestic violence are all becoming common in family court cases, she said. Which doesn't mean that they are easy for courts to decide.

But she noted, "We invented courts to deal with all the difficult problems for which there is no social consensus."

Of course, all of this presumes that California law would apply. I don't know whether New York's law would be any different, but if it is, then this will shape up into an epic choice-of-law battle before it becomes an epic family-law or bioethics battle.

If California is still Diandra's domicile, and the contract was entered into and performed there, and the children are there, presumably California law would apply. Even if the case were litigated in New York, which seems to be what Zack is angling toward, New York courts might well conclude that California law should apply. Or not . . . .

Hospital accused of paying illegal remuneration.

Today's Wall Street Journal has a report (requires subscription) on the case against Alvorado Hospital Medical Center and its former CEO, Barry Weinbaum. Prosecutors charge that the recruitment deal that lured physicians to the hospital constituted illegal remuneration in violation of 42 USC § 1320a-7b(b), which makes it a crime to pay "any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind" in return for a referral.

As common as such recruitment deals are in the health care industry, this is a case worth watching. The WSJ article can be found for free on the San Francisco Chronicle's web site.

U.S. won't appeal jury verdict in St. David's case.

St. David's can rest easy, finally. After an epic struggle with the federal government, St. David's Hospital in Austin can bank on a March 2004 jury verdict, which held that the hospital retained sufficient control after its partnership with HCA that it could remain tax-exempt. According to an item in today's Daily Dose, the U.S. won't appeal the trial court judgment (although it did file a notice of appeal, just in case). According to the article, "Had St. David's lost, it could have owed nearly $40 million in back taxes, interest and penalties, [St. David's CEO Carol] Clark said." You can get a pretty good summary of the case here; the opinion of the U.S. Court of Appeals for the Fifth Circuit lays out the whole case (before the remand that led to the district court judgment that isn't being appealed by the U.S.).

Should Doctors Help With Executions?

Good article in today's N.Y. Times about the ethics of physician involvement in executions. Here's the crux of the problem:

About 25 states allow or require doctors to be present at executions. But information on the number of doctors who participate in executions is hard to come by, as states generally refuse to name anyone who does so, citing security and privacy concerns. . . .

Many of the states that encourage doctors to participate in executions have seemingly contradictory laws that allow doctors to be disciplined by state medical boards for violating codes of medical ethics. Those codes almost universally forbid participation in executions.

The American Medical Association's ethics code, for instance, says that "a physician, as a member of a profession dedicated to preserving life when there is hope of doing so, should not be a participant in a legally authorized execution."

The code forbids doctors to perform an array of acts at executions, including prescribing the drugs, supervising prison personnel, selecting intravenous sites, placing intravenous lines, administering the injections and pronouncing death.

"They're not allowed to determine that the execution has been unsuccessful so that the execution can be repeated," said Dr. Stephen H. Miles, a professor of medicine at the University of Minnesota and author of "The Hippocratic Oath and the Ethics of Medicine."

But a survey of doctors in 2001 found that more than 40 percent would be willing to perform at least one of the forbidden activities.

Scholars who have studied the matter said they knew of no state board action against a doctor for aiding in a lawful execution. . . .

At least eight states . . . also seek to shield doctors from professional discipline through laws saying that aiding in executions is not the practice of medicine.

The AMA Code provision in question is E-2.06.

Interestingly, the Supreme Court may be heading toward a position that the absence of a physician's involvement in lethal injections may contribute to the execution's unconstitutionality. As the Times article points out:

In a unanimous decision on May 24 allowing a death row inmate to challenge lethal injections as cruel and unusual punishment, the United States Supreme Court appeared to suggest that a doctor should be required for at least some procedures.

The inmate in that case, David L. Nelson, had badly damaged his veins by long-term drug use, and went to court to fight a plan by Alabama prison officials to make a two-inch incision in his arm or leg to allow his execution to proceed. "There was no assurance," Justice Sandra Day O'Connor wrote in the decision, "that a physician would perform or even be present for the procedure."

The case in question is Nelson v. Campbell, No. 03-6821.

Doctors getting feisty: are there any ethical limits?

NPR's Morning Edition today ran a segment it describes this way:

A South Carolina doctor is asking the American Medical Association to approve as ethical a policy that would permit doctors to refuse treating medical malpractice lawyers. The proposal demonstrates how heated the debate over medical malpractice has become.

At 4 minutes and 2 seconds, it's well worth a listen. When the transcript becomes available, I'll offer some salient excerpts (in the spirit of Fair Use). For now, here's the gist: Fed up with the perceived effect of allegedly frivolous lawsuits, this physician believes he is so biased against plaintiffs' attorneys that he can't trust himself to provide competent medical care.

The Charleston (S.C.) Post & Courier ran a story about this physician's quest in its May 29 edition (requires free registration):

Tucked among the stacks of resolutions to be debated at the American Medical Association's annual meeting next month will be one that, if approved, is sure to inflame the already white-hot debate over medical malpractice liability reforms. It also may sound familiar to South Carolinians: The proposal urges the AMA to inform doctors that it is not unethical to stop treating attorneys and their families in non-emergency cases.

The man behind the idea is prominent Charleston surgeon Dr. Chris Hawk. In March, he urged doctors at the South Carolina Medical Association meeting to quit treating plaintiffs' lawyers and their families in an effort to soften trial lawyers' resistance to malpractice reform.

That call ignited a firestorm, leading to intense criticism from lawyers and some doctors who called it unethical and said it takes the debate over malpractice premiums too far. . . .

When the AMA's House of Delegates meets June 12, various AMA committees will sift through hundreds of resolutions that delegates will vote on over the course of the three-day meeting. . . .

The resolutions are typically filed by either medical specialty societies or state associations like the South Carolina Medical Association. In this case, Hawk, an AMA delegate, introduced the proposal himself -- a rare occurrence that happens just once or twice a year, an AMA official said.

How well Hawk's proposal will fare is far from certain. In March, when Hawk made similar comments at the SCMA meeting pushing doctors to drop attorney patients, the association's board made it a point to insist that it didn't endorse the idea.

One board member called Hawk's position "totally off the wall."

Hawk said that in his view, it's not unethical to deny care to patients as long as the doctor is not dealing with a medical emergency and as long as the patient is given 30 days' notice.

Here's the text of Hawk's Resolution 202 (Word file):

AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES

Resolution: 202
(A-04)

Introduced by: J. Chris Hawk, III, MD, Delegate, South Carolina

Subject: Reform of Civil Justice System

Referred to: Reference Committee B
(Michael J. Fischer, MD, Chair)

Whereas, Tort reform has been our number one legislative priority; and

Whereas, Our American Medical Association has been concentrating on MICRA-like reform, particularly a cap on non-economic damages, when in fact we need major reform of the entire civil justice system; and

Whereas, Our current efforts at tort reform have failed at a national level; and

Whereas, We need to get beyond tort reform to other issues that are vital to medicine and our patients; and

Whereas, Patients’ access to medical care has diminished progressively and is likely to continue to do so, due to high malpractice insurance premiums forcing physicians to reduce their scope of practice, relocate, and retire early; and

Whereas, Our Principles of Medical Ethics IX states, “A physician shall support access to medical care for all people”; and

Whereas, If trial attorneys were given the opportunity to experience the access problems caused by the professional liability crisis, then perhaps they would be willing to help change the system; and

Whereas, Our Principles of Medical Ethics VI states, “A physician shall, in the provision of appropriate patient care, except in emergencies, be free to choose whom to serve, with whom to associate, and the environment in which to provide medical care” therefore be it

RESOLVED, That our American Medical Association notify physicians that, except in emergencies and except as otherwise required by law or other professional regulation, it is not unethical to refuse care to plaintiffs’ attorneys and their spouses (New HOD Policy); and

RESOLVED, That our AMA organize a national task force, forum, or town meeting to reform the civil justice system, or get medical professional liability moved to an alternate dispute system, with report back by the 2005 Annual Meeting (Directive to Take Action); and

RESOLVED, That our AMA continue our efforts to reform the US health care system.

Fort Worth Star-Telegram editorial writer Linda Campbell has an eminently sensible response to Dr. Hawk's crusade:

This jaw-dropping measure, presented as a means of addressing diminishing access to health care, laments the medical profession's inability to impose a $250,000 national cap on pain and suffering damages in medical malpractice lawsuits - as though that were the magic antidote for chronically bloated insurance premiums.

Among its whereases, the resolution suggests that "if trial attorneys were given the opportunity to experience the access problems caused by the professional liability crisis, then perhaps they would be willing to help change the system."

So, Hawk believes, the AMA should "notify physicians that, except in emergencies and except as otherwise required by law or other professional regulation, it is not unethical to refuse care to plaintiffs' attorneys and their spouses."

Forget about that Hippocratic oath.

Let's indulge in discrimination according to livelihood - not to mention guilt by marital association.

Hawk told The Post and Courier in Charleston, "My obligation now is to try to improve the system, because we already have patients not getting care."

It requires truly warped logic to imagine that this tactic would advance that cause in any fashion.

If anyone thinks that Hawk's effort is merely an aberration, consider that the Christian Coalition of Alabama recently asked candidates for judicial office whether they would pledge to spurn campaign funding from personal injury trial lawyers, The Birmingham News reported. The organization considers Roe v. Wade an "activist" decision, and judges backed by trial lawyers tend to be "judicial activists," and so, of course, you see the connection.

What all this really accomplishes is to distract from meaningful debate about daunting problems.

Forty-three million Americans remain without health insurance. Many suffer for want of treatment. Someone has to pay to treat them when they get sick. But the cost of medical care climbs.

Medical malpractice insurance companies continue to hike premiums even in states that have limited awards for non-economic damages.

Texas voters last fall approved a constitutional amendment capping non-economic damages, but it hasn't immediately translated into lower malpractice insurance rates for many physicians.

Texas Medical Liability Trust reduced its rates by 12 percent, as promised.

But, late last year, the Joint Underwriting Association asked to raise rates 35 percent for physicians, surgeons and other health care providers and almost 68 percent for hospitals, a request denied by Texas Insurance Commissioner Jose Montemayor.

Yet another insurer, General Electric Medical Protective, switched to an unregulated type of insurance so that it could increase premiums by 10 percent.

In Ohio, malpractice premiums are expected to go up 10 percent to 40 percent this year, even though the state adopted pain-and-suffering caps, "The Advocate" newspaper in central Ohio reported in February.

She ends with a comment that gets to the nub of the problem:

Brooklyn Law School professor Anthony J. Sebok wrote in December that the usual suspects with the loudest voices on America's "liability crisis" miss the point about what needs reforming in the tort system.

"It is so expensive to litigate that few deserving victims sue, and many blameless defendants settle just so they can escape the expense and uncertainty of the civil justice system," he wrote on findlaw.com.

That can't be corrected with simplistic solutions or absurd ethical practices.

Dylan, poet redux.

What are the chances that the holder of the poetry chair at Oxford's latest poetical exegesis would land in 13th place on the Amazon.com bestseller list based on pre-publication sales alone? Pretty good, apparently, if the book gets hyped on page one of The New York Times. Less than 24 hours ago, it was at 109 (and that was a few hours after the Times article hit, so it was probably already reflecting the publicity). By the way, for an even more amazing reality check, the punctuation book, Eats, Shoots & Leaves, is holding steady at #3! What's up, America?

Getting the bad news with the good news about a drug.

Today's Philadelphia Inquirer has a good piece about drug studies that are tubed by the drug companies that sponsor them. Here's the set-up:

A doctor is thinking of trying a new drug on a 67-year-old patient because a study shows it works well in men only slightly younger. But the doctor doesn't know about a clinical trial that found serious side effects in older patients. Those results were never published.

John Schneider, a doctor of internal medicine and a member of the American Medical Association's Council on Scientific Affairs, fears that that scenario happens all too often.

Because drug companies often do not reveal the contents of studies that make their drugs look bad, he said, many doctors are frustrated because they sometimes prescribe medications without knowing all the information about them and possible side effects.

Now, the AMA is considering asking the federal government to open up this secretive world. The group's House of Delegates will vote during a meeting that starts Saturday on a resolution urging the U.S. Department of Health and Human Services to create a registry of all clinical trials and their results.

The power of a front-page story in The Times.

When I put up the message below (less than 3 hours ago), Ricks' book on Dylan was ranked 109. Right now, it's ranked 28. The power of the press, indeed. I wonder what it was ranked yesterday at this time (before the Times piece hit the Web). . . .

Bob Dylan -- master poet.

Christopher Ricks, professor of humanities at Boston University and the newly minted Professor of Poetry at Oxford, has a thing for Bob Dylan, and has published a 500-page tome, "Dylan's Visions of Sin" (Ecco Press), in support of the claim that Dylan is a master poet, according to an article in today's N.Y. Times. The Amazon.com sales rank for this book, which will be officially released on June 15, is already 109. Sometimes it pays to be cool.

Organ trafficking.

There was an interesting piece in yesterday's The Christian Science Monitor on international organ sales. Between this article and the lengthy one in the N.Y. Times Magazine on May 23, this topic is getting a lot of attention these days. Is the U.S. policy against organ sales eventually doomed?

A prescription for healthcare.

Does Harvard's Michael E. Porter have the right idea for reforming the health care system? You can sample his ideas in this story from today's Boston Globe. It summarizes an 18-page piece ("Fixing Competition in U.S. Health Care (HBR Research Report)" by Porter and Elizabeth Olmstead Teisberg) in the June issue of The Harvard Business Review. Here's HBR's description of the piece:

The U.S. health care system is in bad shape. Medical services are restricted or rationed, many patients receive poor care, and high rates of preventable medical error persist. There are wide and inexplicable differences in costs and quality among providers and across geographic areas. In well-functioning, competitive markets, such outcomes would be inconceivable. In health care, these results are intolerable. Competition in health care needs to change, say the authors. It currently operates at the wrong level. Payers, health plans, providers, physicians, and others in the system wrangle over the wrong things, in the wrong locations, and at the wrong times. System participants divide value instead of creating it. (And in some instances, they destroy it.) They shift costs onto one another, restrict access to care, stifle innovation, and hoard information--all without truly benefiting patients. This form of zero-sum competition must be replaced by competition at the level of preventing, diagnosing, and treating individual conditions and diseases. Among the authors' well-researched recommendations for reform: Standardized information about individual diseases and treatments should be collected and disseminated widely so patients can make informed choices about their care. Payers, providers, and health plans should establish transparent billing and pricing mechanisms to reduce cost shifting, confusion, pricing discrimination, and other inefficiencies in the system. And health care providers should be experts in certain conditions and treatments rather than try to be all things to all people. U.S. employers can also play a big role in reform by changing how they manage their health benefits.

HHS OIG publishes draft revised hospital compliance guidance.

In today's Federal Register we have the latest addition to the growing body of "compliance guidance" from the Office of Inspector General, this time in the form of changes to the previously published hospital compliance guidance (63 Fed. Reg. 8987 (February 23, 1998)). All of the OIG compliance guidance documents are collected here.

According to the preamble,

When the final version of this document is published, it will supplement the OIG’s prior compliance program guidance for hospitals issued in 1998. This draft contains new compliance recommendations and an expanded discussion of risk areas. The draft takes into account recent changes to hospital payment systems and regulations, evolving industry practices, current enforcement priorities, and lessons learned in the area of corporate compliance.

Among other things, the draft revises the OIG's list of compliance "risk areas":

This section addresses the following areas of significant concern for hospitals: (A) Submission of accurate claims and information; (B) the referral statutes; (C) payments to reduce or limit services; (D) the Emergency Medical Treatment and Labor Act (EMTALA); (E) substandard care; (F) relationships with Federal health care program beneficiaries; (G) HIPAA Privacy and Security Rules; and (H) billing Medicare or Medicaid substantially in excess of usual charges. In addition, a final section (I) addresses several areas of general interest that, while not necessarily matters of significant risk, have been of continuing interest to the hospital community.

Final section (I) discusses (1) discounts to uninsured patients, (2) preventive care services, and (3) professional courtesy.

Pfizer pleads guilty to marketing drug illegally.

While doctors can prescribe drugs for any use, the promotion of drugs for these so-called "off-label uses" is prohibited. The FDA's guidance in this area is relatively clear, although the agency has been somewhat constrained by a federal district court (Washington Legal Foundation v. Friedman (requires WestLaw subscription)). So it was a big deal when Pfizer admitted in a Boston case yesterday that it had engaged in just such illegal marketing, including paying doctors to put their names on ghostwritten articles about the anti-seizure drug Neurontin. The Boston Globe's article is here.

Pediatric deaths due to error - Report.

As reported in today's Daily Dose, Pediatrics has published an article (link is to abstract only) that estimates thousands of pediatric patients die each year due to medical error:

Thousands of children die unnecessarily in hospitals because of medical errors stemming from patient-safety lapses, and the extra cost of care for pediatric patients exposed to 20 types of safety problems exceeds $1 billion annually, according to a study in the June Pediatrics. The study confirmed that medical errors are a significant problem for children as well as adults, and it identified the very young and the very poor as more vulnerable than children in general. Researchers from the department of pediatrics at Johns Hopkins University, Baltimore, said the figures on patient deaths were conservative. The methods used to identify 4,483 unnecessary deaths from an analysis of 5.7 million records in 2000 "can detect only a small portion of the types of patient safety events that actually happen in hospitals," according to the article.

More than 51,000 cases of medical error were discovered, and four of the 20 types of treatment failure occurred at a rate exceeding 100 per 10,000 discharges. Those were failure to rescue a patient suffering from a threatening event, postoperative sepsis, and obstetric trauma with and without the use of instrumentation. The study also recorded the financial cost of each of the 20 types of treatment failure. For example, each case of sepsis resulted in an average of 26 extra hospital days and $118,000 in extra charges.

The abstract concludes: "Patient safety problems for hospitalized children occur frequently and with substantial impacts to our health care industry. Unmeasurable by this study are the additional "costs" and "burdens" of safety events that our patients are forced to handle. Additional work to describe and quantify better these outcomes in addition to ones measured here can help solidify the "business case" for patient safety efforts."

Washington Post analyzes Kerry's health plan.

In its Saturday issue, The Washington Post ran an article by Ceci Connolly on the Kerry health plan. In the "we've heard this before" category, the plan seeks to obtain health-care savings (and therefore reduced premiums, and therefore more coverage for the working uninsured) through electronic medical records and disease-management requirements. The plan would also position the federal government as payor of last resort for catastrophic claims, in much the same role as it plays as ultimate reinsurer after natural disasters and terrorist attacks. The federal government would pay employers 75% of the cost of "catastrophic claims," defined as a single employee's claims over $50,000 in any one year. As Connelly notes: "Such catastrophic claims account for less than half of 1 percent of all claims but generate 20 percent of the nation's health care costs, according to the latest federal data." The relief felt by employers, insurers, and employees (hopefully) would come at a cost: "In exchange for the benefit, Kerry would require employers to offer insurance to every worker and to provide health programs that detect and manage chronic illnesses such as high blood pressure early enough to prevent the diseases from worsening." And the federal tab? "Emory University health economist Kenneth E. Thorpe estimates the reinsurance program would save businesses and employees $288 billion in premiums over a decade but cost the government $257 billion because of administrative reductions." Most of that price would be covered by rolling back tax breaks delivered to the wealthy after the 2002 mid-term elections.

How Private Is My Medical Information?

The Privacy Rights Clearinghouse has a good report on medical records and privacy, with a special emphasis on information that is not covered by HIPAA.

50-state rundown on gay-marriage laws.

Stateline.org has published a very helpful summary (updated June 4) of pending legislation, including constitutional amendments, from around the various states. Stateline.org says it "is a non-partisan, non-profit online news publication that reports each weekday on state government. Funded by The Pew Charitable Trusts it was created in 1999 to strengthen and enrich U.S. political journalism by providing information about political activity in the 50 state capitols. In an era of declining news media presence in statehouses, Stateline.org helps fill the coverage gap." Good web site to know about . . .

Stem cell research ethics debated.

Yesterday's Cincinnati Enquirer ran an interesting debate over the ethics of stem-cell research, with Jeffrey Kahn arguing in favor and John Willke arguing against the practice.

Indigent care: Texas Attorney General Op. No. GA-0198.

Texas Attorney General Greg Abbott issued an AG Opinion on indigent health care yesterday. It seems the Amarillo Hospital District sold its hospital, Northwest Texas Hospital, to Universal Health Systems of Amarillo, Inc., in 1996. UHS acquired, along with the hospital, the county's indigent-care obligations pursuant to Chapter 61 of the Health and Safety Act. Since then, UHS has noticed that some patients appear to have voluntarily waived their right to obtain employer-sponsored health insurance, preferring instead to obtain hospital services as indigent patients rather than as insured patients. UHS wanted to know whether they could require these patients to sign up for health insurance benefits with their employers so that UHS could obtain reimbursement for services rendered. The AG's answer, in a word, was "no." Here's the rationale:

In this case, the [Indigent Health Care and Treatment] Act does not contemplate that a health care provider may require an applicant for indigent health care to obtain insurance through the applicant's employer in certain circumstances. Section 61.007(5) of the Health and Safety Code, requiring an applicant to provide information regarding the "existence of insurance coverage," is phrased in the present tense. Tex. Health & Safety Code Ann. § 61.007(5) (Vernon 2001). It is concerned with an applicant's coverage at the time of the application, not the availability of coverage or the potential for coverage in the future. The Department's [i.e., the Department of State Health Services'] rule requiring an applicant to list information about any medical insurance household members "receive," see 25 Tex. Admin. Code § 14.101(a)(3)(E) (2004), similarly focuses on whether the applicant is insured at the time he or she applies for indigent health care. No other provision in chapter 61 of the Health and Safety Code or in the Department's rules expressly or implicitly authorizes a hospital district to require an applicant to purchase health insurance as a prerequisite to receiving indigent health care.

Moreover, absent a provision in the special law creating it, a hospital district has no authority to require an applicant to obtain insurance before the applicant is eligible for indigent health care. "A hospital district has only such authority as is expressly conferred on it by statute or necessarily implied from the authority expressly conferred to effectuate the express powers." Tex. Att'y Gen. Op. No. JC-0068 (1999) at 1. Without express authority, a hospital district may not adopt a standard for determining an applicant's income and resources that is stricter than the Department's standard. See Tex. Health & Safety Code Ann. § 61.052(a)(2) (Vernon 2001); see also id. § 61.052(e) (stating that, if the Department changes its income and resources requirements so that the hospital district's standards become stricter than the Department's, the hospital district must change its standard to at least comply with the Department's requirements). Because neither the statute nor the Department's rules permit a requirement that an applicant purchase insurance, any such hospital district requirement would be more restrictive than the state requirements and, absent express authority, would be impermissible under the statute.

Schiavo case on fast track to Florida Supreme Court.

The 2nd District Court of Appeal has approved Michael Schiavo's request that Jeb Bush's appeal go directly to the Supreme Court, which allows the litigants to bypass the intermediate appellate stage in the dispute over the validity of "Terri's Law," according to an article in the Tallahassee Democrat. Thanks to Kathy Cerminara for the heads up on this.

Meanwhile, Terri's parents are again contesting her husband's right to make medical decisions for her -- an issue that has been litigated and re-litigated and always comes out the same way every time - in favor of the husband. The Second District Court of Appeal's opinion from last June neatly summarizes the issue. Apparently "finality" is a foreign concept in Florida's court system.

For more on the lower court's opinion and other recent developments in this case go here and here.

Additional thoughts on late-term abortions.

If the Administration and Congress were serious about having a law that would pass constitutional muster, Pub. L. No. 108-105 needs only two simple changes. First, make it clear that the prohibition does not apply to any procedure that is performed before the fetus is viable. Second, include an exception so that the prohibition doesn't apply when it is necessary to protect the health of the pregnant woman. Both provisions are easy to write. Both come directly out of the Stenberg opinion, in which the Supreme Court struck down Nebraska's partial-birth abortion law because it failed to include these two provisions. And both would probably have increased support for the bill in Congress.

The absence of these two simple features suggests a number of possibilities:

• Maybe Congress and the Administration were more interested in a confrontation with the federal courts over partial-birth abortion than they were in enacting any meaningful legislation.


• Or perhaps Congress and the Administration were more interested in creating a campaign issue for the summer and fall of 2004 than they were in banning a procedure that is so rarely used but has such potent political symbolism.


• Finally, it is possible that the Administration and both houses of Congress truly believe that if this loose thread can be successfully pulled away from the body politic, the entire fabric of Roe v. Wade will surely follow.

Health insurance coverage and the kindness of strangers.

Health Affairs' May/June issue has an interesting article that show that workforce characteristics are a bigger influence on health care coverage rates than state health policies. Here's the journal's press release and summary:

Working In Communities With Greater Number Of ‘Advantaged’ Workers
Increases Likelihood Of Employer-Sponsored Coverage
BETHESDA, MD — Although there is wide variation across the country in the rate of employer-sponsored insurance, almost all of the variation can be accounted for by variation in individual demographic characteristics, employment characteristics, and a community effect, according to a new paper published today by Health Affairs and the California HealthCare Foundation.

Author Richard Kronick, a professor with the University of California, San Diego, and two colleagues use Current Population Survey data to demonstrate that community characteristics exert a strong “contextual effect” on employer-sponsored coverage. . . .

According to Kronick, all individual and job characteristics being equal, workers are more likely to receive employer-sponsored coverage in communities with a large proportion of high-income adults and greater numbers of manufacturing and public administration jobs, rather than those whose economy is weighted toward low-income adults, minority workers, and small-business jobs.

Kronick and colleagues conclude that the demographic characteristics of a community have more bearing on rates of employer-sponsored insurance (ESI) than do state policies aimed at reducing the number of uninsured, such as small-group market reform or elimination of benefit mandates.

“In almost all states the actual rate of ESI is within one or two percentage points of the level that would be expected based on demographic and employment characteristics and the contextual effect,” Kronick says.

“Other than Hawaii, there is very little that states have done to move the rate of ESI either substantially above or below the rate that would be expected based on the demographic and employment characteristics of the people who live in the state. The only effective action that any state has taken to substantially increase the level of ESI among workers is to require employers to offer insurance,” as Hawaii has, Kronick says.

The authors find that a worker with a given set of characteristics (age, race/ethnicity, income, family structure, size of employer, industry, health status, home ownership, and union membership) is 3.5 percentage points more likely to have employer-sponsored insurance if they live in a metropolitan area with a high-wage, high-skill economy than if the workers lives in an average metropolitan area.

“There is a strong contextual effect on coverage rates,” Kronick says. “Although there are wide variations across states in the rate of (employer-sponsored insurance), almost all of the variation can be accounted for by the combination of individual characteristics and the contextual effect.”

The authors offer three potential explanations for the “contextual effect”:

In areas where there are the types of workers who expect to have ESI (well-educated, higher-income, native-born Anglos), employers will be more likely to offer coverage. As a result, the search costs for a marginal worker to find a job offering insurance will be lower than in areas where there are fewer employers offering insurance

Total compensation, including ESI and other benefits, is more likely to higher in areas with larger numbers of higher-skilled workers

Workers in high-coverage areas may prefer to search longer for jobs with ESI, while workers in low-coverage areas may find it more acceptable to go without coverage

In other words, poorer and less urban states, with a less skilled workforce and fewer high-end and skilled jobs, can't do much to raise the rate of ESI, short of attracting more skilled jobs, more high-end employers, etc. And that means simultaneously granting tax breaks and spending more on improving public services, paying attention to public education and public health, all of which requires a stronger tax base. How does a comparatively poor state dig itself out of this hole?

The skewed politics of assisted suicide.

Liberals touting states' rights. Conservatives pooh-poohing individual liberty and freedom. The are just some of the political side-effects of the debate over physician-assisted suicide in the wake of the 9th Circuit's opinion last week telling the Justice Department (and John Ashcroft personally) to take a hike and leave Oregonians and their Death With Dignity Act alone. Today's on-line Wall Street Journal surveys the political wreckage (requires subscription), and helpfully provides links to various commentators:

• Associated Press article;


• Newsday editorial;


• Seattle Post Intelligencer editorial;


• spokeswoman for American Catholic Bishops Conference;
and

• editorial in LifeNews.com.

NY Times' extensive coverage of life and death under Oregon's PAS law.

The New York Times has a series of articles today about the reality of living and dying under Oregon's physician-assisted suicide law. The lead article is here. There is also a multimedia presentation on the voices of the terminally ill, which links off the main story page, and a brief story (with photos) of a woman who invited her friends in to experience her death together.

More on partial-birth abortion ruling.

Here's the essence of Judge Hamilton's ruling this morning (see below).

1. The partial-birth abortion law is unconstitutional in three respects.
a. The statutory definition of the procedure could apply to previability D&E procedures as well as inductions. It could also apply to the interventions performed by physicians who treat a woman experiencing a spontaneous second-trimester miscarriage. Physicians may face criminal prosecution under the statute for procedures than cannot always be predicted when they begin to treat their patients. This could reduce the availability of such procedures and could have an adverse impact on the physicians who continue to do the procedures. All of this amounts to an "undue burden," as that phrase has been explained in Casey and Stenberg: the law "has the effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus." The Nebraska law at issue in Stenberg was struck down for the same reason.
b. The law is unconstitutionally vague in two material respects: "partial-birth abortion has little if any medical significance; "living fetus" adds to the vagueness of the law because it does not pertain to viability or to the framework of Roe and Casey; and neither the "overt act" nor the scienter requirements of the statute save the law from unconstitutional vagueness.
c. Notwithstanding the extensive findings of Congress to the contrary, the Court concluded that the intact D&E procedure (referred to in Stenberg as "D&X" or "dilation and extraction") is relatively safe, and it may be safer than any of the alternative procedures under some circumstances. Therefore banning the procedure could endanger women's health. The Nebraska law at issue in Stenberg was struck down for the same reason.

2. The extensive Congressional findings in support of Congress' conclusion that intact D&E is never necessary for the health of the mother were reviewed by the court under an intermediate review standard, neither de novo (as the plaintiffs argued) nor with the extreme deference sought by the government's lawyers. Applying a standard akin to a "hard look," the court concluded that these findings were "unreasonable and . . . not supported by substanttial evidence [that] was available to Congress at the time."

Federal court declares partial-birth abortion law unconstitutional.

At 9:00am this morning, Federal District Judge Phyllis Hamilton issued a 117-page order permanently enjoining the enforcement of the federal partial-birth abortion law. The order is here (PDF); the statute may be viewed here.

As reported this morning by the San Francisco Chronicle:

The ruling applies to the nation's 900 or so Planned Parenthood clinics and their doctors, who perform roughly half of all abortions in the United States.

U.S. District Judge Phyllis Hamilton's ruling came in one of three lawsuits challenging the legislation President Bush signed last year. . . .

Federal judges in New York and Nebraska also heard challenges to the law earlier this year but have yet to rule. . . .

Late last year, Hamilton, a Clinton appointee, and federal judges in New York and Lincoln, Neb., blocked the act from being enforced pending the outcome of the court challenges. They began hearing testimony March 29. . . .

The Nebraska and New York cases are expected to conclude within weeks. The outcomes, which may conflict with one another, will almost certainly be appealed to the Supreme Court.

The New York case was brought by the National Abortion Federation, which represents nearly half the nation's abortion providers. The Nebraska case was brought by a few abortion doctors.

Alan Morrison . . . living greatly in the law.

Alan Morrison is closing shop at the Public Citizen Litigation Group in Washington and leaving for a teaching job at Stanford, according to an article in the May 24th Legal Times (requires paid subscription; also available on WestLaw). This is the lawyer who brought us Virginia Pharmacy Board, Chadha, Bowsher, Mistretta, and the motion to recuse Justice Scalia from the Cheney energy case (which Scalia denied, but which probably led to Chief Justice Rehnquist's recent announcement that he has created a panel to look into judicial ethics on the high court).

Morrison's bold attempt to get Scalia out of the Cheney case is illustrative of his career:

The episode captures an essential truth about Morrison, one of the nation's top public interest lawyers, as he looks back over his 32 years with the Ralph Nader-founded Public Citizen Litigation Group. He is fearless about challenging government and corporate interests, yet also has no fear of befriending -- or at least being cordial to -- their advocates and icons.

"There's no reason not to deal with people in a civil manner," Morrison says. "I don't consider myself a rebel. I like having people return my phone calls."

Even in his parting, a range of luminaries returned his phone calls and formed a host committee for a June 3 farewell dinner for Morrison that will also fund a fellowship in his name. The list spans the spectrum of the legal establishment -- from former Whitewater Independent Counsel Kenneth Starr to Harvard Law School professor Laurence Tribe, Reagan Solicitor General Charles Fried to Clinton SG Seth Waxman, Reagan White House Counsel Fred Fielding to Clinton Chief of Staff John Podesta. "Alan Morrison is deeply respected throughout the entire Washington community," says Starr, now partner in the D.C. office of Kirkland & Ellis. "His conservative friends may not always agree with him, but they know he is a person of complete intellectual honesty."

For my students, the closing words of the article are memorable:

Throughout his career, Morrison says, he was never tempted by the astronomically higher salaries he could have made if he had put his tenacity and litigating skills to work for a private firm. At Public Citizen he was paid no more than $80,000 a year, he says, and even when he supplemented that with an adjunct law school teaching gig, "I'm still making less than a first-year associate at a New York firm."

But Morrison says the rewards have been incomparable. Pointing to Craig's book about the litigation group's early days, he says, "I hope young people read it and say to themselves, 'You know, there's a better way to spend my life.' You work here, and there's no competition, you don't have to make partner." One young lawyer on his staff once told him the job was so fulfilling and fun, "I don't think we should get paid."

Morrison recalls the words of his friend the late public interest activist Joseph Rauh Jr., who once said, "They made all the money; we had all the fun."

New Texas Supreme Court case on workers' comp.

Texas Workers' Compensation Commission v. Patient Advocates of Texas, No. 02-0804, decided May 28:

In 1989, the Legislature enacted a new Workers’ Compensation Act in response to rising medical costs and increasing insurance premiums. The Legislature created the Texas Workers’ Compensation Commission and gave the agency broad powers to adopt rules necessary for the implementation and enforcement of the Workers’ Compensation Act. TEX. LAB. CODE § 402.061. One of TWCC’s new functions was to establish fee guidelines for reimbursements to health care providers who treat injured workers. Id. § 413.011. To this end, the agency promulgated the Texas Workers’ Compensation Commission Medical Fee Guideline 1996, adopted by reference in Rule 134.201 of the Texas Administrative Code. See 28 TEX. ADMIN. CODE § 134.201 (indicating that copies of the Guideline may be obtained from TWCC’s publication department). The Guideline contains the maximum allowable reimbursements (MARs) for thousands of medical procedures. The MARs establish upper limits on the amount of reimbursements payable to health care providers for the listed treatments or services. TWCC also promulgated a set of rules, now commonly referred to as the “Dispute and Audit Rules,” which establish a process for insurance carriers to review and audit bills submitted by health care providers. Id. §§ 133.301-.305.2 The rules also set up dispute resolution procedures to resolve disagreements over the necessity of medical procedures and the amount of reimbursements. Id. § 133.305. Requests for medical dispute resolution must be filed not later than one year from the date of the medical service. Id. § 133.305(d).

TWCC’s adoption of the Guideline and the Dispute and Audit Rules are at the base of this dispute. Patient Advocates of Texas and Allen J. Meril, M.D. (collectively PAT) initiated this lawsuit claiming that TWCC did not follow the rulemaking procedures required by statute when promulgating the Guideline. Additionally, PAT asserts that TWCC exceeded its rulemaking authority by setting a ceiling on many medical fee reimbursements and limiting the time for a party to seek medical dispute resolution to one year from the date the medical service was provided. PAT also challenges the validity of the Dispute and Audit Rules alleging that TWCC illegally delegated its audit and fee-setting authority to private insurance carriers. Lastly, PAT raises constitutional challenges to the rules on the grounds that the MARs and the one-year time limitation constitute a taking of their property without due process and just compensation. In response, TWCC argues that its enactment of the Guideline meets statutory procedural requirements and the limits placed on medical payments are consistent with the agency’s authority to establish medical policies and guidelines pursuant to section 413.011 of the Labor Code. TWCC claims that it retains its power to audit workers’ compensation participants and establish medical fees, and that the Dispute and Audit Rules are simply a means to facilitate insurance carriers’ review of the medical claims submitted by health care providers.

The Supreme Court concludes "that TWCC complied with the statutory requisites for promulgating the fee guidelines and acted within its designated powers in limiting specified medical fee reimbursements and the time to seek medical dispute resolution. We affirm the court of appeals’ judgment on these issues. Because we conclude that TWCC did not delegate its power to private entities, we reverse the portion of the court of appeals’ judgment that is contrary to this conclusion. We also overrule the constitutional challenge to TWCC’s fee reimbursement guidelines and time limitations for commencing medical dispute resolution."

Radicalized elders turn to drug smuggling.

Good article by Elisabeth Weil in today's N.Y. Times re: groups of elders who engage in illegal prescription drug reimportation. The piece is entitled "Grumply Old Drug Smugglers."

Harvard Medical amends conflict-of-interest policies

Trend-setter Harvard Medical School has amended its conflict policy for researchers, acording to an article in The Boston Globe.

Under the policy, Harvard faculty cannot own more than $30,000 in stock from public companies that benefit from their research, a $10,000 increase from the previous limit. They cannot have any stock from companies with which they have ongoing research collaborations. In addition, faculty members cannot own stock in private companies related to their research. But faculty can receive up to $20,000 in consulting fees from companies tied to their research, also a $10,000 increase from the previous limit. . . .

Until now, faculty could not hold upper management jobs in firms. The new policy extends this prohibition to include the positions of chief scientific officer and chief medical officer, slots Harvard faculty occasionally accept.

The new policy was crafted by Harvard medical dean Dr. Joseph B. Martin, in consultation with several faculty committees. He noted that some faculty members argued for looser rules that would foster increased interaction with Boston's vibrant biotechnology and pharmaceutical communities.

''The issues that some individuals raised were set aside for two reasons: that we need to protect human subjects in research . . . and that there not be any perception of bias in research work," he said.

But of faculty collaborations with industry, Martin said: ''We encourage it in every possible way." The increase in the stock and consulting limits, said Martin, reflected what he thought ''responsible people ought to be able to take in."

The Office of Public Health and Science at HHS published its own guidance on this subject on May 12.

Monkey business affects waiting times on transplant list in Albany.

Modern Healthcare's Daily Dose is reporting (alternate link) that yesterday the New York Health Department "fined Albany (N.Y.) Medical Center Hospital $18,000 for falsely reporting patient information in its heart-transplant program. The state accused the 576-bed academic medical center of exaggerating the seriousness of patient conditions to move transplant candidates higher on the transplant waiting list." Need it be added that this type of manipulation of the system only breeds fear and mistrust of transplantation programs?

Maternal-fetal conflicts: a moving target.

The Associated Press had a good article this week on a raft of recent cases in which authorities of one kind or another have come into conflict with pregnant women and the decisions they made concerning childbirth. Here's a link to the CNN publication of the story, which should be pretty stable for the next few months or years.

Interesting intersection of universal health care coverage, same-sex marriage, and domestic-partners' benefits

There is an Associated Press story out (published in today's Portsomouth (N.H.) Herald) about my hometown, Springfield, Mass. The article reports that Springfield is dropping health benefits for same-sex unmarried domestic partners of city employees. Cost is an obvious culprit, but there is also the issue of Massachusetts' decision to allow same-sex marriages. Now that this option is legally available, the city seems to be saying, what's the justification for domestic-partner benefits?

As pointed out in the article, however, same-sex couples may decide to remain unmarried in order to adopt children in countries than ban adoptions by married same-sex couples. And Springfield's three-month phase-out may leave out in the cold those couples that cannot (or choose not to) get their marital act together that quickly. Mayor Charlie Ryan (who was also mayor during my high school days, 37 years ago, and whom I always regarded as an exceptionally straight shooter) says his new order will bring the city into compliance with state insurance laws, though that didn't seem to be a high priority until now.

As for cost: Cambridge Vice-mayor Marjorie Decker is quoted as saying, "It’s an interesting debate for any city or town," she said. "We’re at the crossroads of what happens when you don’t have some universal form of health care." Cambridge, as well as other employers, is confronting the same choices:

Decker expects the city will eventually debate the issue. She predicts that some will argue that domestic-partnership benefits should be extended to all couples who are in long-term committed relationships, rather than forcing them to marry in order to access health benefits. . . .

Among Boston-area employers, Beth Israel Deaconess Medical Center and Babson College will discontinue domestic-partner benefits at the end of the year.

Employers including Massachusetts Institute of Technology, Brigham and Women’s Hospital, Massachusetts General Hospital, Fidelity Investments, Gillette Co. and EMC Corp. will maintain the benefits. Harvard University plans to maintain them for the immediate future, but will revisit the issue in the next two years.

Stay tuned . . . .

Physician-Assisted Suicide.

I am no great fan of legalizing physician-assisted suicide (PAS). But once a state has gone down that road, as Oregon has with its Death With Dignity law, it's exceedingly important for the federal government to get out of the way and not impose its pro-life political stance on states that see things a little differently. Just as this administration has done with California's experiment with medical marijuana, it has tried to squelch the Oregon initiative by leveraging its enforcement powers under the Controlled Substances Act. And just as it did last December in the California medical-marijuana case (Raich v. Ashcroft), the United States Court of Appeals for the Ninth Circuit last week hammered the Department of Justice for its use of the Controlled Substances Act, this time to interfere with Oregon's experiment with PAS. In State of Oregon v. Ashcroft, the judges scolded the Attorney General for "violating the plain language of the CSA, contravening Congress’ express legislative intent, and overstepping the bounds of the Attorney General’s statutory authority." Its concluding paragraph is sweeping in its condemnation of Ashcroft's attempt to impose his personal morality on the citizens of Oregon:

In sum, the CSA was enacted to combat drug abuse. To the extent that it authorizes the federal government to make decisions regarding the practice of medicine, those decisions are delegated to the Secretary of Heath and Human Services, not to the Attorney General. The Attorney General’s unilateral attempt to regulate general medical practices historically entrusted to state lawmakers interferes with the democratic debate about physician assisted suicide and far exceeds the scope of his authority under federal law. We therefore hold that the Ashcroft Directive is invalid and may not be enforced.

The irony in all this is that this most avowedly pro-State, anti-federalist administration hasn't hesitated to try to impose its will on the states when it perceived a hint of political mileage that might be gained with the far right, even when it means shamelessly trampling individual liberties and the traditional role of the states in regulating the practice of medicine.

Prisoner Abuse and Doctors' Duty.

Over the past few years, a couple of medical journals have quite regularly published articles on the torture and abuse of prisoners and detainees and the duty of physicians. Among the most active on this topic have been JAMA, Annals of Internal Medicine, Lancet, and BMJ; a PubMed search for articles with "torture" in the title turns up 589 hits. Until now, it's been easy to dismiss those articles as being of little relevance to most American physicians, let alone the general public. But as a letter in today's NY Times reminds us, "military doctors at Abu Ghraib returned several times to 'stitch wounds, tend to collapsed prisoners or see patients with bruised or reddened genitals' ('Only a Few Spoke Up on Abuse as Many Soldiers Stayed Silent,' front page, May 22). . . . As a medical student, I know that under those circumstances, any doctor should have known that torture was going on in the prison. The fact that those physicians did not speak up constitutes an abandonment of their duties both as soldiers and as doctors."

Texas Supreme Court decides informed-consent case.

In one of its famously tardy decisions (argued April 23, 2003; decided May 7, 2004), the Texas Supreme Court, in an opinion by Justice Owen (frequently the author of famously tardy opinions), unanimously held last week in Binur v. Jacobo, No. 02-0405, that "an erroneous prognosis that is the basis for recommending surgery cannot be the basis of a cause of action for lack of informed consent." Plaintiff claimed that she never would have consented to a bilateral mastectomy if her doctor hadn't erroneously and negligently opined that she was going to develop breast cancer. The court ruled that the risk of an erronoeous diagnosis or prognosis is not the type of risk the Legislature and the Texas Disclosure Panel require to be disclosed. Relying on the List A disclosures for radical or modified radical mastectomy, the Court noted that the required disclosures include the following:

(A) Limitation of movement of shoulder and arm.
(B) Swelling of the arm.
(C) Loss of the skin of the chest requiring skin graft.
(D) Recurrence of malignancy, if present.
(E) Decreased sensation or numbness of the inner aspect of the arm and chest wall.

None of the risks listed for this or any other procedure on List A include the risk that the physician's diagnosis or prognosis that supports his or her recommendation that the procedure be performed is or may be incorrect. If a physician told a patient that she had cancer and was therefore recommending a hysterectomy, the risks enumerated by the Texas Disclosure Panel do not include the risk that the surgery may be unnecessary. The risk that a physician may have erroneously made a diagnosis or prognosis as a predicate to recommending surgery is not inherent in any particular surgery or procedure or medication. That is a general risk of consulting a physician.

This opinion is consistent with those of four Texas courts of appeals. The Supreme Court emphasized that the negligent diagnosis or prognosis could give rise to a negligence claim, but in this case the plaintiff had waived those claims over the course of the litigation. It probably doesn't need to be emphasized that the consent process may be flawed, irredeemably so, when the practitioner affirmatively misleads the patient with statements that are known to be false, simply to procure a consent.

IRS ruling a template for hospital-physician deals.

As reported yesterday by Modern Healthcare, the IRS has issued Revenue Ruling 2004-51, which lays out the ground rules for nonprofit health care providers who want to go into ancillary joint ventures with for-profit entities. According to the story:

The five-page revenue ruling offers a template for how not-for-profit hospitals can protect their tax-exempt status and avoid paying unrelated-business income taxes in joint ventures with physicians or for-profit companies. . . .

[A] tax-exempt university asked for IRS guidance on its plan to offer training programs for elementary and secondary schoolteachers. The university would team up with a for-profit, interactive-video company in a 50-50 joint venture, with each partner naming three directors to the board. The governance agreement would prohibit activities contrary to the university's tax-exempt status, require the university to remain at arm's length in negotiations for contracts and other transactions, and establish fair-market value as a benchmark for prices.

The IRS said those stipulations would protect the university's tax-exempt status, and there would be no unrelated-business income taxes because the venture was an extension of the university's educational mission and insubstantial compared with its overall activity.

Schiavo timeline and significant documents.

Thanks are due to professors Steven Haidar and Kathy Cerminara for putting together a most useful timeline for the Schiavo case. My only suggestion for an additional citation is to the actual session law version of Terri's Law: chapt. 2003-418. The timeline is otherwise an altogether admirable and useful attempt to pull together everything a person might want to know about the history of this sad, sad case.

"Terri's Law" declared unconstitutional by Florida court.

It didn't seem possible that the case could come out any other way, but at least it's now official. On Wednesday, Circuit Judge W. Douglas Baird of the Circuit Court for the Sixth Judicial Circuit in and for Pinellas County declared that the hastily enacted Terri's Law (chapt. 2003-418), which authorized Gov. Jeb Bush to issue an executive order directing that artificial nutrition and hydration be restarted in Terri Schiavo, unconstitutional under a variety of provisions of the Florida Constitution:

• First, the court held that the law effects an unconstitutional delegation of legislative power to the governor, in violation of Art. II, sec. 3, of the Florida Constitution and separation-of-powers principles. The gist of this holding is that the legislature provided Gov. Bush with virtually no standards to guide his exercise of discretion as to whether to order the reinstatement of life-sustaining measures and for how long.

• Second, the court held that statute violates Terri Schiavo's right of privacy, a right that was added to the Florida Constitution in 1980 (Art. I, sec. 23). Section 23 provides: "Every natural person has the right to be let alone and free from governmental intrusion into the person's private life except as otherwise provided herein. This section shall not be construed to limit the public's right of access to public records and meetings as provided by law. "

• The court also found that the law was retroactive legislation and an unconstitutional intrusion into the judicial function.

The governor's office filed an immediate appeal, but by relying exclusively upon the Florida constitution, the trial judge has effectively immunized this case from review in the Supreme Court of the United States, so -- despite the seemingly inexhaustible willingness of Terri Schiavo's parents and Jeb Bush to litigate -- the end of this legal saga is in sight.

Limits on Stem-Cell Research Re-emerge as a Political Issue.

A month before the attacks on September 11, President Bush made the first major speech of his presidency, in which he announced the administration's new policy on federal funding for stem-cell research. The new policy significantly modified (PDF) (HTML) the NIH guidelines (PDF) (HTML) (corrected Nov. 21 (PDF) (HTML)) hammered out by NIH Director Harold Varmus in the waning days of the Clinton Administration and limited the use of federal funds for research on cell lines that had been derived from embryos before the date of the president's speech, August 9, 2001. Since then, many questions have arisen concerning the number, variety, and availability of stem-cell lines, as well as the underlying policy determination that federal funds should not be used to extract stem cells from newly created blastocysts or from frozen embryos that are the result of IVF fertility treatments. Interestingly, these questions do not track traditional Dem/GOP, liberal/conservative, pro-life/pro-choice political lines, with Nancy Reagan and Oren Hatch, among others, emerging as early and consistent supporters of more aggressive federal support for stem-cell research. The President's Council on Bioethics, which was created after August 9 as a source of advice to the president on such issues, put out a "monitoring report" on stem-cell research in January 2004, as well as a report on human cloning (both for reproduction (they recommended a ban) and -- importantly for the stem-cell issue -- for scientific research (they recommended a moratorium, with significant dissent within the Council)) in July 2002.

As reported in today's New York Times, the question of the federal government's funding policies is emerging as an issue in Campaign 2004. Stay tuned . . .

Quality of care lacking in a majority of communities in US.

Another article from the May-June issue of Health Affairs that is sure to create some buzz:

• "Profiling The Quality Of Care In Twelve Communities: Results From The CQI Study," by Eve A. Kerr, Elizabeth A. McGlynn, John Adams, Joan Keesey and Steven M. Asch.
  Abstract: Health care quality falls far short of its potential nationally. Because care is delivered locally, improvement strategies should be tailored to community needs. This analysis from the Community Quality Index (CQI) study reports on a comprehensive examination of how effectively care is delivered in twelve metropolitan areas. We find room for improvement in quality overall and in dimensions of preventive, acute, and chronic care in all of these communities; no community was consistently best or worst on the various dimensions. Having concrete estimates of the extent of the gap in performance should stimulate community-based quality improvement efforts. (Full text requires subscription to journal.)

As reported in today's New York Times:

Americans get substandard care for their ailments about half the time, even if they live near a major teaching hospital, the first comprehensive study of health care provided in metropolitan areas has found.

The inadequate treatment leads to "thousands of needless deaths each year," said Dr. Elizabeth A. McGlynn, a researcher at the RAND Corporation . . . .

The study's conclusions were based chiefly on a review of the medical records of nearly 7,000 people in 12 metropolitan areas, including Newark, Miami and Orange County, Calif. On average, the authors found, patients received substandard care, as defined by leading medical groups, 50 percent to 60 percent of the time. There was little variation among the metropolitan areas, randomly selected from 60 with populations of at least 200,000. The areas included cities and their suburbs.

Texas Leads Nation in Percentage of Uninsured Workers.

As reported in today's New York Times, Texas leads the nation (again) in the percentage of its population without health insurance, with 27 percent. For a measure of the financial strains on health care institutions and providers in the Deep South and Southwest generally, the national honor roll of states with the highest percentage of uninsured includes, in order: Texas (27%), Louisiana (23%), Mississippi (22%), New Mexico (22%), Oklahoma (21%), and Nevada (21%). This graphic pretty much tells it all:



The full report (Characteristics of the Uninsured: A View from the States (May 2003), from the Robert Wood Johnson Foundation) is here.

Two must-read articles in the current issue of Health Affairs.

• "How Does the Quality of Care Compare in Five Countries?," by Peter S. Hussey, Gerard F. Anderson, Robin Osborn, Colin Feek, Vivienne McLaughlin, John Millar and Arnold Epstein -- 23(3):89-99.
  Abstract: International data on quality of medical care allow countries to compare their performance to that of other countries. The Commonwealth Fund International Working Group on Quality Indicators collected data on twenty-one indicators that reflect medical care in Australia, Canada, New Zealand, England, and the United States. The indicators include five-year cancer relative survival rates, thirty-day case-fatality rates after acute myocardial infarction and stroke, breast cancer screening rates, and asthma mortality rates. No country scores consistently the best or worst overall. Each country has at least one area of care where it could learn from international experiences and one area where its experiences could teach others.



• "U.S. Health Care Spending In An International Context," Uwe E. Reinhardt, Peter S. Hussey and Gerard F. Anderson -- 23(3):10-25.
  Abstract: Using the most recent data on health spending published by the Organization for Economic Cooperation and Development (OECD), we explore reasons why U.S. health spending towers over that of other countries with much older populations. Prominent among the reasons are higher U.S. per capita gross domestic product (GDP) as well as a highly complex and fragmented payment system that weakens the demand side of the health sector and entails high administrative costs. We examine the economic burden that health spending places on the U.S. economy. We comment on attempts by U.S. policy-makers to increase the prices foreign health systems pay for U.S. prescription drugs.

The full text of both articles can be accessed through the links above, though access may require a paid-up subscription to the journal. Both articles are summarized in a news report in today's Wall Street Journal, which also may require a paid subscription.

HHS/CMS effort to silence CMS' chief actuary probably violated federal law.

The Kaiser Family Foundation's Daily Health Policy Report has done an excellent job in today's report rounding up the various strands of the story about the squelching of CMS' chief actuary:

The Congressional Research Service on Monday concluded that Bush administration officials "appear to have violated federal law" by barring CMS chief actuary Richard Foster from sharing with lawmakers his cost estimates for the Medicare legislation, the Wall Street Journal reports (Rogers, Wall Street Journal, 5/4). CRS is a branch of the Library of Congress and provides nonpartisan analysis and research to lawmakers (Pugh, Philadelphia Inquirer, 5/4). The analysis comes more than one month after Foster told members of the House Ways and Means Committee that he had shared with Doug Badger, President Bush's health policy adviser, and James Capretta, associate director of the Office of Management and Budget, his analysis that the Medicare legislation would exceed its target spending goal. According to OMB estimates released after Congress passed the legislation, the Medicare law will cost $534 billion over the next 10 years, $134 billion more than estimated by the Congressional Budget Office. Foster has said that the higher cost projection was known before the final House and Senate votes on the legislation in November but that former CMS Administrator Tom Scully told him, "We can't let that get out." In an e-mail to colleagues at CMS, Foster indicated he believed he might lose his job if he revealed his cost estimates for the Medicare legislation. Scully has said that he did not threaten to fire Foster if the higher estimates were released. Scully also said that he "curbed Foster on only one specific request" made by Democrats at the time of the first House vote on the Medicare bill (Kaiser Daily Health Policy Report, 3/25).

Analysis Details. In a nine-page memo to Rep. Charles Rangel (D-N.Y.), ranking member of the Ways and Means Committee, CRS said that federal officials "do not have the right to prevent or prohibit" employees from sharing information concerning "relevant public policy issues" to congressional members (Goldstein, Washington Post, 5/4). Further, Congress' "right to receive truthful information from federal agencies to assist in its legislative functions is clear and unassailable," the analysis states. According to CRS, since 1912, federal laws have protected federal employees' rights to communicate with lawmakers, and more recent laws have "reaffirmed and strengthened" those rights (Pear, New York Times, 5/4). Jack Maskell, a legislative lawyer at CRS, said that in 1997, "when some lawmakers felt that the Clinton administration threatened the candor of federal health experts, House and Senate appropriations conferees wrote into health care legislation" that the CMS Office of the Actuary serves both the administration and the Congress, the Inquirer reports. In addition, the legislation states that the actuary's independence to provide data to Congress is "vital," according to the Inquirer (Philadelphia Inquirer, 5/4). Thus, Scully's order "would appear to violate a specific and express prohibition of federal law," according to CRS (New York Times, 5/4). However, CRS said that such an act "may not rise to level of a criminal violation" (Heil, CongressDaily, 5/3). According to the Inquirer, Scully probably could not be prosecuted because "only individual lawmakers sought Foster's estimates." Scully could not be reached for comment Monday (Philadelphia Inquirer, 5/4).

Democrats' Response. The CRS report prompted Rangel, who requested the analysis, and Rep. Pete Stark (D-Calif.), House Ways and Means Health Subcommittee ranking member, to request a new committee hearing on the estimates (CongressDaily, 5/3). According to the Journal, some House Democrats "seized the nine-page memo" to reaffirm their argument for subpoenas to make Scully and Badger testify regarding their knowledge of the "alleged 'gag order'" (Wall Street Journal, 5/4). Scully and Badger declined to appear before the House panel when it considered the estimates last month (Kaiser Daily Health Policy Report, 4/2). In a letter, Rangel and Stark reminded House Ways and Means Committee Chair Bill Thomas (R-Calif.), who has declined previous requests to subpoena Scully or Badger, that he has said he would support a subpoena "if it was clear that laws had been broken," CongressDaily reports. In the letter, Rangel and Stark said, "It is clear that laws were broken. ... Indeed, the administration's steadfast refusal even now to release the requested information raises serious questions as to the ongoing violations of the spirit, if not the letter, of these laws" (CongressDaily, 5/3). HHS Secretary Tommy Thompson last week said he would not release additional documents related to Bush administration cost estimates for the Medicare law, despite a formal request from Democrats on the House Government Reform Committee (Kaiser Daily Health Policy Report, 4/29).

Administration Reaction According to the Journal, CRS "is respected by the administration" and therefore, the CRS analysis "makes it harder to isolate the complaints as driven by election-year politics and Democrats who opposed the bill" (Wall Street Journal, 5/4). However, HHS spokesperson Bill Pierce on Monday said that the department is "focusing on instituting the new Medicare law and not on the Scully-Foster controversy" (Philadelphia Inquirer, 5/4). Pierce added that "we are looking to the future, not the past" (New York Times, 5/4).

U of Wash update.

One interesting aspect of the qui tam case, the settlement of which was announced this morning, is that the "plaintiff" (technically, the qui tam relator) was their former compliance officer.

The Seattle Times has updated its story, to reflect the actual settlement announcement this morning.

The complaint, which was filed under seal in 1999 and released today, is here.

Qui tam action against Univ. of Washington teaching hospital settles for $35 million

Assuming the Seattle Times got it right in their article this morning, the pending announcement of a settlement in the False Claims Act suit against them is the final chapter in an appalling tale of lawlessness on the part of a pillar of the Seattle health-care community:

[W]hen [a 1996 compliance] program was put into place, auditors found rampant errors. Doctors were routinely overbilling Medicare and Medicaid, charging for more expensive services than those they had performed. According to the lawsuit, auditors found evidence of this in nine out of 10 departments at the Children's University Medical Group, the billing group for UW doctors who practice at Children's Hospital and Medical Center.

When UW Physicians found out, according to the lawsuit, it hid the practice by changing the compliance policy, making it acceptable to round up, meaning doctors could charge for a treatment that was one rung higher on the billing chart than the treatment they had actually provided.

With the new rules in place, UW Physicians began a second audit for 27 specialty departments. Even under the more permissive rule, though, the errors poured in, according to the lawsuit. The majority of errors came from doctors who were charging for services two or more rungs higher than the services performed. In the dermatology department, 90 percent of the cases reviewed were incorrectly billed. Rates were 57 percent for infectious-diseases, 21 percent for pulmonary and 22 percent for craniofacial.

Best of all, "UW Physicians destroyed the old reports, the lawsuit said, and wrote new, sanitized versions."

Bioethics novels.

Just came across this author profile from the April 18th edition of The Providence Journal. I don't know if Jodi Picoult's books are any good, but I plan to find out this summer. From a bioethics perspective, the most promising appear to be the recently published My Sister's Keeper (producing offspring in order to have a marrow donor for another child), Mercy (euthanasia), and Second Glance (sterilization laws).