Science & politics redux.

Today's N.Y. Times has an article by Mireya Navarro ("Experts in Sex Field Say Conservatives Interfere With Health and Research") that sounds a familiar theme:

For years, Advocates for Youth, a Washington-based organization devoted to adolescent sexual health, says, it received government grants without much trouble. Then last year it was subjected to three federal reviews.

James Wagoner, the president of Advocates for Youth, said the reviews were prompted by concerns among some members of Congress that his group was using public funds to lobby against programs that promoted sexual abstinence before marriage. Although that was not the case, Mr. Wagoner said, the government officials made their point.

"For 20 years, it was about health and science, and now we have a political ideological approach," he said. "Never have we experienced a climate of intimidation and censorship as we have today."

Mr. Wagoner is among the professionals in sex-related fields who have started speaking out against what they say is growing interference from conservatives in and out of government with their work in research, education and disease prevention.

A result, these professionals say, has been reduced financing for some programs and an overall chilling effect on the field, with college professors avoiding certain topics in their human sexuality classes and researchers steering clear of terms like sex workers in the title of grant applications for fear of drawing attention to themselves.

"Programs almost have to hide what they do," said Richard Parker, a professor at the Mailman School of Public Health at Columbia University. "We have a major challenge ahead of ourselves."

Sound paranoid? It gets worse: "Professor Parker is also a co-chairman of the International Working Group on Sexuality and Social Policy, an association of researchers and other professionals, which released a report two weeks ago citing examples of what it called sex policing under the Bush administration. The report cited, for example, changes in factual information about sex education and H.I.V. transmission on government Web sites as well as questioning by members of Congress about research grants approved by the National Institutes of Health."

Stem cells and cloning.

The United States' failure to work out a comprehensive and comprehensible set of policies on stem cell research and human cloning is emblematic of a wider, international failure. In an excellent review piece in this week's issue of The Lancet, Carol A. Tauer (Univ. of Minn.) surveys the wreckage and suggests a new approach to forging a consensus.

Mixing science & politics (again).

In an editorial in this week's issue, the editors of the British medical journal The Lancet take the Bush Administration to task for its new policy by which DHHS'

Office of Global Public Health will choose which, if any, US Government scientists can serve as advisers to WHO. Instead of going directly to the experts they want as technical advisers, as WHO has done in the past, the organisation must now provide the Office of Global and Public Health, which is headed by a political appointee, with "terms of reference" for each proposed consultation--a process that it concedes "will require a minimum lead-time of 3 weeks". A written directive goes on to remind WHO that US Government employees are required "to serve as representatives of the US Government at all times and advocate US Government policies".

A spokesman for the HHS strongly denied charges that this newly resurrected policy represents any attempt by the Bush administration to exercise political control over the exchange of scientific information, describing it instead as a method "to create accountability" and to ensure that WHO works with appropriate experts. He said that agency heads have not always been aware of the consulting activities of their employees, and that no specific cases prompted the action.

The editors allow as how HHS' denials ring a little hollow in light of this administration's demonstrated willingness to shade the truth when science doesn't quite fit its political plans. I like the editors' suggestions for ways the Bushites can prove their sincerity:

But let us give the Bush administration the benefit of the doubt. If this move is meant to provide accountability, let us have some from HHS. First, to dispel any perception of divided loyalties, put a career civil servant, not a political appointee, in charge of the process. Then, to ensure proper public accountability, let HSS put on its website names of those consultants WHO asked for, whether HHS agreed with the requests or approved someone else, and the rationale for the decision. Finally, disclose all of the evidence: how long did the approval process take, and at what cost? The public, whom the administration claims to be protecting, can then decide whether this policy streamlines or obfuscates the process of global scientific consultation, and whether it is a good use of the government's time--and taxpayers' money. We would guess not.

2 new cases from Texas Supreme Court.

The Texas Supreme Court had a pretty heavy opinion day on Thursday and handed down a couple of cases of potential interest to health care providers. Providers prevailed in both actions, thus maintaining a winning streak in the Supreme Court that must stretch back years.

Utica National Insurance Co. of Texas v. American Indemnity Co., ___ S.W.3d ___ (Tex., No. 02-0090, July 9, 2004): majority opinion; dissenting opinion.
Mid-Cities Surgi-Center employed a scrub technician who stole fentanyl, an anesthetic, from the surgical center. Apparently using the same syringe, the technician removed fentanyl from the glass ampules in which it was stored, injected himself with the drug, then injected saline solution back into the ampules to hide his theft. He then re-sealed the ampules with super glue and re-wrapped them with cellophane to further hide his crime. Because the technician was infected with Hepatitis C, his use of a dirty syringe allegedly contaminated the ampules. A number of patients who received fentanyl injections, including the four plaintiffs in this lawsuit, subsequently tested positive for Hepatitis C. Plaintiffs sued Mid-Cities Anesthesiology, P.A., a professional association of ten doctors who practiced anesthesia at the surgical center, and the association's member anesthesiologists. The patients alleged numerous negligent actions against the doctors' association and its members, including negligence in "failing to properly secure anesthesia narcotics" and in "exposing patients to contaminated medication." The association's professional liability insurer originally assumed defense of the suit, but later became insolvent. The Texas Property and Casualty Insurance Guaranty Association (TPCIGA) then assumed its obligations.

TPCIGA tendered the suit for a defense and coverage to the Association's general liability insurer at the time of the litigation, American Indemnity, which denied coverage because it was not the insurer at the time the infections occurred. TPCIGA then tendered the suit to the Association's general liability insurer at the time the plaintiff's became infected, Utica National, which denied coverage based upon an exclusion in its policy for "[b]odily injury . . . due to rendering or failure to render any professional service." After TPCIGA and American Indemnity settled the claims, they brought suit against Utica National for defense and settlement costs. The trial court granted motions for summary judgment by TPCIGA and American Indemnity, holding that Utica National's exclusion for professional services did not preclude coverage and awarded judgment against the defendant for the defense costs and full settlement costs, with attorney's fees and pre- and post-judgment interest.  The Court of Appeals in Austin affirmed.

Held: Reversed in part and remanded. The policy excludes coverage only when the insured has breached the standard of care in rendering those professional services. In this case, the allegations in the pleadings raised both the possibility that the treating doctors were negligent in their administration of the drug and the possibility that the doctors' association was negligent in the storage of that drug. Because the plaintiffs alleged both professional and non-professional negligence, the general liability insurer had a duty to defend the underlying suit in this case under the eight-corners doctrine. But because a fact issue exists about whether the patients' injuries were caused at least in part by the doctors' rendition of professional services, in which event Utica National's policy would not cover the doctors' association, the Supreme Court remanded the indemnity claims to the trial court for further proceedings.

Justice Hecht dissented in an opinion joined by Justice Owen. The essence of his opinion is set out in the following passage: "I cannot see how it is remotely possible for a physician to be negligent in preserving the purity of medications administered to patients by himself and those with whom he associates and yet not be in breach of a professional standard of care. Thus, I would hold that the patients' claims were for professional liability, against which Utica had no obligation under its CGL policy to defend or indemnify. The Court does not foreclose this result but remands for fact findings. If I am correct C if the association and its members could not have been negligent without violating a professional standard of care C the outcome will eventually be the same."

Martinez v. Val Verde County Hospital District, ___ S.W.3d ___ (Tex., No. 03-0611, July 9, 2004): opinion.

Kaelyn Martinez, age 3, underwent a tonsillectomy at the Val Verde Regional Medical Center. Kaelyn’s parents, Marcus Martinez and Mary Koog, filed suit a little over two years after the operation, individually and on behalf of Kaelyn, against the Val Verde County Hospital District (which operates as the Medical Center) and others.  The Hospital District is a governmental unit immune from suit under the Texas Tort Claims Act, Tex. Civ. Rem. & Pract. Code § 101.001 et seq., but Martinez and Koog invoked the Act's exception for liability based upon the use of tangible property,
id. § 101.021(2).

The Act requires that a governmental unit receive notice of any claim against it within six months of the incident giving rise to the claim unless it already has actual notice. Id. § 101.101. The Hospital District first received notice of the claims of Kaelyn and her parents six months and twenty-two days after Kaelyn’s surgery, and Martinez and Koog did not contend that the Hospital District had actual notice before then. Accordingly, the Hospital District filed a plea to the jurisdiction, asserting that because it did not receive notice as
required by the Act, its immunity from suit was not waived, and the court lacked subject matter jurisdiction of the claims against it. The trial court sustained the plea and ordered the case dismissed with prejudice.

The parents argued (1) that the notice requirements of the Act are not jurisdictional and therefore the trial court had subject matter jurisdiction of their claims, and (2) that the notice provision of the Act should be tolled if the claimant is a minor, unless the statute clearly states that its time limits are not tolled during a claimant's minority. The court of appeals held that Kaelyn’s minority did not toll the six-month period for giving notice.  The court also ruled that notice is not a condition of the Act’s waiver of immunity that should be raised in a plea to the court's jurisdiction but instead is an affirmative defense that should be raised by motion for summary judgment. The court therefore reversed the trial court’s dismissal for want of jurisdiction and remanded the case for further proceedings.

Held: Affirmed. As to the appellants' tolling argument, the Supreme Court, per Justice Hecht, observed, "One can believe, as the court of appeals did, that it is unfair to require a minor who cannot sue to give the notice required by the Tort Claims Act, but the State is not required to waive immunity from suit at all. The fairness or wisdom of the waiver is not our province to decide."

French ban human cloning.

According to the International Herald-Tribune, France has banned human cloning (now punishable by up to 30 years in prison and a fine of over US$ 9 million). They also suspended their ban on stem cell research on human embryos for five years. AP reports (courtesy of the Seattle Post-Intelligencer) that the prison term is 20 years. It also says that the new bioethics law, originally introduced by the Socialist government almost 3 years ago, does not include a provision that would have made it legal for a widow to be impregnated with an embryo created when her husband was still alive.

Studies Look at Health Care in the U.S.

The N.Y. Times ran a short article in today's paper surveying some of the emerging theories, and the developing consensus, among health care economists. After reviewing the usual benchmarks that place the United States at or near the bottom of developed countries in health-care measure despite spending more, and more per capita, than the others, author Jeff Madrick, continues:

What may surprise readers, and certainly surprised this writer, is that Americans, by paying so much more, do not have many more services. In fact, according to recent research, they typically have fewer. Consider the number of doctors. In 2001, the United States had 2.7 doctors per 1,000 people, compared with a median of 3.1 in the countries in the Organization for Economic Cooperation and Development. France, accused of having a doctor shortage in last summer's heat wave, had 3.3 per 1,000.

Also, consider the number of hospital beds. The United States has only 2.9 hospital beds per 1,000 people, compared with the O.E.C.D. median of 3.9. Germany has 6.3. The United States is also behind in the actual days spent in a hospital and hospital admissions per capita. These are not necessarily bad in themselves, but the question is why we spend so much.

The reason for the high level of American spending, argue the researchers - Uwe E. Reinhardt of Princeton and Peter S. Hussey and Gerard F. Anderson of Johns Hopkins - is that American doctors and hospitals charge much more. Americans also usually pay significantly more for drugs, they say, and administration expenses are exorbitant.

OIG's statement re: Scully, the CMS chief auditor, and the price of Medicare reform.

The Acting Principal Deputy Inspector General's statement is on the OIG website. Chairman Grassley released a brief statement about the IG's report and posted it to the Senate Finance Committee's website. The IG's statement says the report has been forwarded to the Secretary of HHS, but so far there's nothing in that agency's web site about the report. The folks who should be really upset at this are the Republicans who relied on CMS' budget projections when they cast their votes in favor of Medicare last fall. Where's the noise?

Also, OIG may have concluded that Scully broke no laws, but apparently the nonpartisan Congressional Research Service concluded otherwise. At least, that's what Rep. Charlie Rangel said in a letter to the chairman of the House Ways and Means Committee, in which he quotes from the CRS report that he (Rangel) requested. So far, at least, the CRS report itself seems not to be available on the Web.

According to Rangel's letter, the laws in question are 5 U.S.C. § 7211, §§ 618 and 620 of P.L. 108-199 [NOTE: see 118 Stat. 354-55 (pp. 352-53 of 455)], 42 U.S.C. § 1317, and 5 U.S.C. § 2302(b)(8).

For a great summary of the issues, the responses, and the next steps for this controversy: Kaiser Family Foundation's Daily Health Policy Report.

Health Affairs' mega-med-mal issue.

The July/August issue of Health Affairs was released today, and it's a doozy: half the issue is devoted to observations, empirical studies, and prescriptions for what is universally described as a medical-malpractice crisis. Here are some of the highlights (from the free previews and abstracts on the journal's web site):

• The Forgotten Third: Liability Insurance And The Medical Malpractice Crisis, William M. Sage [Abstract]:
  Although the most visible manifestations of medical malpractice involve patient safety and the legal process, the availability and affordability of liability insurance largely determine the direction of medical malpractice policy. Scientific and industrial developments since the first modern malpractice crisis in the 1970s reveal major problems with the structure and regulation of liability insurance. Comprehensive reforms that approach medical malpractice insurance as a health policy problem are needed, and the Medicare program may have a major role to play.


• A Mediation Skills Model To Manage Disclosure Of Errors And Adverse Events To Patients, Carol B. Liebman and Chris Stern Hyman [Abstract]:
  In 2002 Pennsylvania became the first state to impose on hospitals a statutory duty to notify patients in writing of a serious event. If the disclosure conversations are carefully planned, properly executed, and responsive to patients’ needs, this new requirement creates possible benefits for both patient safety and litigation risk management. This paper describes a model for accomplishing these goals that encourages health care providers to communicate more effectively with patients following an adverse event or medical error, learn from mistakes, respond to the concerns of patients and families after an adverse event, and arrive at a fair and cost-effective resolution of valid claims.


• Improving The Medical Malpractice Litigation Process, Catherine T. Struve
  [Abstract]:
  Critics charge that judges and juries are incompetent to address medical liability issues. Some advocate shifting authority away from ordinary judges and juries, either by appointing "expert" decisionmakers, such as "medical screening panels" or specialized "medical courts," or by instituting caps on damages. Problems with the tort liability system may weigh in favor of a shift to a no-fault administrative compensation system. If the current fault-based system is retained, however, policymakers should not adopt half-measures by creating "expert" panels or "expert" courts. Rather, they should better equip the existing decisionmakers to deal with liability and damages questions.


• Caring For Patients In A Malpractice Crisis: Physician Satisfaction And Quality Of Care, Michelle M. Mello, David M. Studdert, Catherine M. DesRoches, Jordon Peugh, Kinga Zapert, Troyen A. Brennan, and William M. Sage [Abstract]:
  The rhetoric of malpractice reform is at fever pitch, but political advocacy does not necessarily reflect grassroots opinion. To determine whether the ongoing liability crisis has greatly reduced physicians’ professional satisfaction, we surveyed specialist physicians in Pennsylvania. We found widespread discontent among physicians practicing in high-liability environments, which seems to be compounded by other financial and administrative pressures. Opinion alone should not determine public policy, but physicians’ perceptions matter for two reasons. First, perceptions influence behavior with respect to practice environment and clinical decision making. Second, perceptions influence the physician-patient relationship and the interpersonal quality of care.


• Are Damages Caps Regressive? A Study Of Malpractice Jury Verdicts In California, David M. Studdert, Y. Tony Yang, and Michelle M. Mello [Abstract]:
  Caps on damages have emerged as the most controversial legislative response to the new malpractice crisis. We analyzed a sample of high-end jury verdicts in California that were subjected to the state’s $250,000 cap on noneconomic damages. We found strong evidence that the cap’s fiscal impact was distributed inequitably across different types of injuries. In absolute dollar terms, the reductions imposed on grave injury were seven times larger than those for minor injury; the largest proportional reductions were for injuries that centered on pain and disfigurement. Use of sliding scales of damages instead of or in conjunction with caps would mitigate their adverse impacts on fairness.

Scully pressured actuary, didn't break law: OIG reports

According to a report in this afternoon's "Daily Dose" (by Modern Healthcare), the DHHS OIG has concluded that Tom Scully did, indeed, pressure the CMS chief actuary to withhold the true price tag ($524 billion over 10 years) of the Medicare prescription drug benefit from Congress last fall. More than that, the Administration's earlier (and affirmatively false) figure of $395 billion was allowed to stand, because of Republicans in Congress who announced they would not support a reform package that cost more than $400 billion. No action will be taken against Scully, who no longer works for the government (he's in the DC office of Alston & Bird), and the OIG has further concluded that no criminal laws were violated. Congress itself is looking into that question, so time will tell. This story broke with the announcement that the OIG would be testifying about its conclusions before Sen. Grassley's Senate Finance Committee this afternoon. (Nothing about this appears on the committee's web site, on the OIG's "current testimony" web page, or -- needless to say -- Alston & Bird's web site as of 4:00pm today.)

Do pediatricians need lawyers in order to provide good care?

That's the tantalizing question in an article in the July 2004 issue of Pediatrics. The full article isn't available on the web, but an abstract is:

PEDIATRICS Vol. 114 No. 1 July 2004, pp. 224-228

--------------------------------------------------------------------------------

SPECIAL ARTICLE

Why Pediatricians Need Lawyers to Keep Children Healthy
Pediatricians recognize that social and nonmedical factors influence child health and that there are many government programs and laws designed to provide for children’s basic needs. However, gaps in implementation result in denials of services, leading to preventable poor health outcomes. Physician advocacy in these arenas is often limited by lack of knowledge, experience, and resources to intervene. The incorporation of on-site lawyers into the health care team facilitates the provision of crucial legal services to vulnerable families. Although social workers and case managers play a critical role in assessing family stability and finding appropriate resources for families, lawyers are trained to identify violations of rights and to take the appropriate legal steps to hold agencies, landlords, schools, and others accountable on behalf of families. The incorporation of lawyers in the clinical setting originated at an urban academic medical center and is being replicated at >30 sites across the country. Lawyers can help enhance a culture of advocacy in pediatrics by providing direct legal assistance and case consultation for providers, as well as jointly addressing systemic issues affecting children and families. Until laws to promote health and safety are consistently applied and enforced, pediatricians will need lawyers to effectively care for vulnerable children.
--------------------------------------------------------------------------------
Barry Zuckerman, MD, Megan Sandel, MD, MPH, Lauren Smith, MD, MPH and Ellen Lawton, JD

From the Department of Pediatrics, Boston Medical Center/Boston University School of Medicine, Boston, Massachusetts

Medicine and literature.

Catching up on some reading . . . the May 22 issue of The Lancet continues its series of articles by (or, in earlier installments, about) physician-writers with a truly splendid piece by Brazilian physician and author Moacyr Scliar. All are available for free (albeit with a brief registration form). Here are all the articles in this series that I know of:

• Moacry Scliar
• Martin Winckler
• Richard Selzer
• Jerome Groopman
• Perri Klass
• John Murray
• Phil Whitaker
• Jed Mercurio
• Khaled Hosseini
• Samuel Shem
• Atul Gawande
• Rita Charon
• Cecil Helman
• Jonathan Kaplan

I hope students in the Law, Literature & Medicine class I teach with Patty Hicks will get the chance to read a few of these.

Meanwhile, permit me this idle speculation: Where have all the serious lawyer-writers gone? Most seem to have settled for the easy bucks of mass-market pot-boilers with an option on the screenplay, soon to be a major motion picture opening in theater near you. Scott Turow is the exception - a gifted writer whose mysteries transcend the genre by lifting the entire enterprise up a level or two. My Scottish compadre, Sandy McCall-Smith, has done the same with his successful series on Mma. Precious Ramotswe of Botswana and her No. 1 Ladies Detective Agency. For another generation, Louis Auchincloss was comfortable writing serious fiction, and his near-contemporary was the poet Archibald MacLeish. And . . . ?

Health reform and the presidential election.

Last month (June 5), the British medical journal The Lancet hopefully titled its editorial on U.S. health care and the November election, "Bush vs Kerry: health is a critically decisive issue" (free). After surveying the relatively tepic health-reform proposals of both the Bush and the Kerry camps, however, and reminding us that the Clintons' experience in 1993 has probably turned ambitious health reform into one of the many "third rails of American politics," the editorial doesn't seem to hold out much hope for anything major in this election cycle. Voters themselves, "say they are for health reform, most, being middle class, have health insurance, and have, in the past at least, proved to be reluctant to support changes that they fear might drive up their own costs or threaten their benefits." So, in the great American tradition of doing the right thing only after all other alternatives have been exhausted, the editorialists conclude: "But as the current health-care crisis continues, and as more and more middle-class Americans see their out-of-pocket expenses rise and their benefits threatened, voters may be ready to heed calls for far more fundamental reform than either candidate now dares to propose."

The Vice-President's physician.

This week's New Yorker has an article by correspondent Jane Mayer on VP Cheney's physician's battle with addiction. The New York Times and The Washington Post picked up the story in this morning's editions, too. Specifically, the physician who famously declared Cheney fit for office four months before Cheney suffered his fourth heart attack has been battling an addiction to narcotics for nine years. Last month, he was removed as chair of George Washington University Medical Center's Department of General Internal Medicine and from the Veep's health care staff.

Mayer does a good job detailing the extent of the physicians' purchases and, inferentially, his impairment:

According to pharmacy records and customer invoices, in July, 2000, for example, the month that Malakoff wrote the letter certifying Cheney’s good health, he purchased thirty bottles of a synthetic narcotic nasal spray called Stadol from two mail-order drug-supply companies. Stadol, which can be addictive, is ordinarily used to treat migraine headaches. Each bottle contains an estimated fifteen doses. In the previous two months, he had bought eighteen bottles. In August, he bought twenty-eight more bottles. During the two-and-half-year period ending in December, 2001, Malakoff spent at least $46,238 online on Stadol and such medications as Xanax, Tylenol with codeine, and Ambien.

That's 76 bottles (and 1140 doses) in 5 months. The guidelines for prescribing the drug call for 1 dose, followed by another dose in 60-90 minutes if there is no relief from the first dose, followed by additional 2-dose sequences as needed every 3-4 hours, so Cheney's doc's 7.5 doses per day (assuming he consumed all 1140 doses during the five-month period that he placed his orders) are within the prescription guidelines for the drug. Adding Schedule III-IV drugs like Xanax, Tylenol with codeine, and Ambien, however, suggest a serious problem. (It's unclear, though, how much of the other drugs he was taking. At $92 a bottle (from drugstore.com) he would have spent $41,400 on Stadol during the two-and-a-half-year period described in Mayer's article, leaving only about $5,000 for other drug purchases.)

The issue in all this isn't the fall of a presumably talented physician into the clutches of a dastardly affliction, tragic as that is. The questions raised by Mayer's article, explicitly or implicitly, are:

• Whether the GWU administration responded appropriately when they learned of their colleague's addiction. Even though prescribing under another physician's name and DEA number, which is apparently how these prescriptions were obtained, is a civil and cirminal offense, it appears that GWU informed neither the DC licensing board nor the DEA.


• In addition to the public's legitimate interest in the health of high-ranking public officials, does the public have a similar interest in the health of the health providers who care for those public officials and pronounce them fit for office?

Medical ethicist: Honesty isn't always the best policy.

Daniel Sokol, a medical ethicist of the Imperial College Faculty of Medicine, London, has an interesting piece in the International Herald Tribune defending the use of deception in the rare case in which honesty (i.e., respecting a patient's autonomy) might lead to death or serious harm -- that is, when truth-telling is clearly not in the patient's best interests. Sokol's presentation is pretty standard fare, and most ethicists and clinicians, I suspect, would agree with his article. It's important, however, to keep this exception to the principle of respect for autonomy within bounds, lest the exception swallow up the rule.

Sokol's short piece doesn't provide much guidance for one of the more perplexing debates in medical ethics: whether it's ever ethical to prescribe a placebo for a therapeutic purpose. (Good bibliography here.) Conventional wisdom has it that the placebo effect is lost when the patient is told that she is getting a sugar pill or other inert substance, so the efficacy of the placebo depends upon deception. Sokol allows for the deception when necessary to avoid significant harm ("nonmaleficence"); would his argument also allow for deception in order to achieve a therapeutic benefit ("beneficence")? The overwhelming consensus among ethicists appears to be "no," yet the practice seems to persist among practitioners for what appears to be a variety of reasons. This piece by Gregory Loeben does a nice job of making the case against deception to produce a benefit for the patient.

July 4: George III & George II.

Cheers to the N.Y. Times editorial editors for running Barbara Ehrenreich's brilliant op-ed, "Their George and Ours." As she works her way through the Declaration of Independence's bill of particulars against George III, the parallels to our own present leaders' policies keep mounting. They will catch some flak for running this piece, I'll wager, but who can object to the closing three paragraphs:

But it is the final sentence of the declaration that deserves the closest study: "And for the support of this Declaration . . . we mutually pledge to each other our Lives, our Fortunes and our sacred Honor." Today, those who believe that the war on terror requires the sacrifice of our liberties like to argue that "the Constitution is not a suicide pact." In a sense, however, the Declaration of Independence was precisely that.

By signing Jefferson's text, the signers of the declaration were putting their lives on the line. England was then the world's greatest military power, against which a bunch of provincial farmers had little chance of prevailing. Benjamin Franklin wasn't kidding around with his quip about hanging together or hanging separately. If the rebel American militias were beaten on the battlefield, their ringleaders could expect to be hanged as traitors.

They signed anyway, thereby stating to the world that there is something worth more than life, and that is liberty. Thanks to their courage, we do not have to risk death to preserve the liberties they bequeathed us. All we have to do is vote.

Mammalian cloning continues to pose safety concerns.

From the BBC, there's a story today about U.S. researchers from Cornell who reported to the European Fertility Conference in Berlin that mouse experiments comparing assisted reproduction techniques with cloning showed "significantly impaired development in the cloned embryos compared with those derived from more conventional ART techniques and this has made us more convinced that reproductive cloning is unsafe and should not be applied to humans." The article quotes the executive director of the European Society of Human Embryology and Reproduction: "There is absolutely general agreement that reproductive cloning should be banned. It's clear from all the available experiments that it's much too dangerous." Researchers conduct research, and technologists exploit technology, because scientific challenges exist to be conquered. For the time being, only the most reckless will attempt to clone humans for reproduction, but when the safety issues is tamed, we will have to give serious consideration to the non-safety objections to reproductive cloning that were raised by the President's Council on Bioethics.

Has the U.S. lost its capacity for outrage?

That's the question I asked myself after reading Art Caplan's piece in Newsday today. Art tells the tale of the recent meeting in Denver of the American Society of Concierge Physicians: "Concierge medicine is a special, high-end form of medical care that guarantees that if you need treatment you will get it, without a hassle, seven days a week-but only for an extra fee. If you can pay amounts that range from $20 to thousands of dollars a month, you can guarantee that your phone calls will be promptly returned by your doctor and that you'll get special attention whenever you're admitted to a hospital." He contrasts the "quality medicine for the rich" philosophy of the ASCP with TennCare's recent cutbacks to the state's Medicaid program:

It is making over its state Medicaid program known as TennCare. If this program gets implemented, many of the poor, elderly, children and disabled in Tennessee who rely on Medicaid will be told simply to get over it. And other hard-pressed states may well follow suit.

Gov. Phil Bredesen, a former HMO entrepreneur, sees the challenge of health care for the poor in Tennessee in very stark terms. In a speech last February, the governor described the state Medicaid program as nothing more than an open checkbook that is continuously being raided by "doctors and hospitals and advocates" who "decide what is needed."

Caplan's opening paragraph provides a fitting close, as well: "Just how bad is the state of health care in America? Well, consider two recent developments that shine a spotlight on a system that was already showing signs of severe distress, even before the Supreme Court decided to let HMOs off the legal hook. In Colorado the rich are paying what amount to bribes to make sure that they are at the head of the line when it comes to getting health care, and in Tennessee the poor are basically being told to get lost."

I've examined concierge, or "boutique," medicine in this space before, and as recently as last week reported on a hospital in the tony Hamptons on Long Island that has offered "concierge emergency care" contracts to selected (and wealthy) residents in its service area. I understand the frustration physicians feel on the daily treadmill practicing "hamster medicine," as well as the doom and gloom many state CEO's feel as they contemplate the sinking of state budgets by seemingly boundless growth in the demand for health care dollars. But neither of the developments chronicled in Caplan's piece provides a viable answer to managed care woes or the problems of the indigent and the uninsured. In fact, what they both have in common is a set of blinders that allows the concierge docs and the state to say, "Screw the consequences. We're holding on to whatever we can keep for ourselves, despite the cost to the system."

PhRMA proposes guidelines for publication of negative clinical trial results.

As previously noted, this is generating a lot of interest on the part of the press, NYS Att'y Gen'l Eliot Spitzer, and others. (Kaiser Foundation's web page has a good summary of the various strands of this issue.) Now the drug industry's trade association, PhRMA, has revised its principles on the subject, according a story in today's Wall Street Journal (requires paid subscription). Click for the press release, a backgrounder on clinical trials, and "Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results." The updated voluntary guidelines call for "timely communication of meaningful study results, regardless of the outcome of the study," and apply to clinical trials started after October 2, 2002.

Companies are currently required to publicize the results of trials only in connection with initial applications for marketing permission, but not in the post-marketing phase when drugs are tested for their efficacy in connection with other diseases or in comparison with other drugs. An editorial in today's Washington Post notes that pressure to publish negative results may backfire: "Forcing companies to publish results of all trials, as opposed to the fact of their existence, is more complicated, because a simple government regulation requiring publication of all results of all clinical trials might backfire and wind up discouraging companies from conducting any trials at all. For that reason, Congress -- not the New York courts -- needs to take up this issue again and look at incentives that might persuade companies to conduct more and better clinical trials, even if they aren't commercially advantageous. It should also consider establishing a routine, nationwide system of comparative drug testing, using university and other academic researchers. Any system that leads to the concealment or manipulation of research isn't serving doctors, patients or, in the end, even drug companies very well."

Lucky for Florida the antitrust laws don't apply to state action.

As reported in today's "Daily Dose" from Modern Healthcare: "Florida banned specialty hospitals aimed at a single condition and eliminated its certificate-of-need law for new adult open-heart surgery and angioplasty programs at general hospitals. The law, signed yesterday by Gov. Jeb Bush, also exempts from CON the addition of beds to existing structures, but a CON is still required for new structures. . . . 'There are no single-specialty niche hospitals in the state of Florida at this time, and this legislation would prevent any development,' [Ralph Glatfelter, Sr. VP at the Florida Hospital Association] said." Hospitals generally hate the competition from specialty hospitals, especially when the new entity is financed and/or organized by members of the general hospital's own medical staff. Some hospitals have succeeded in dodging the bullet by joining with their docs in a joint-ventured specialty hospital. For hospitals that lack the money or the good relationship with their physicians to pull off a joint venture, the new competition can be devastating. Florida's new laws -- SB 182 and HB 329 -- provide such hospitals with welcome relief from the competition.

Charity care and nonprofit hospitals: ABA teleconference materials (4/28/04).

Here's a page of good background materials on charity care and tax-exempt status generally, some policy considerations from Nancy Kane at Harvard's School of Public Health, and some local insights into Champaign County's decision to revoke the tax-exempt status of Provena Covenant Medical Center. After diligently scouring the Web, I have come up empty-handed in my search for a copy of the decision of the Illinois Department of Revenue in that case.

More on Provena Covenant.

The Kaiser Family Foundation's website has a good summary of the WSJ journal article mentioned below. The Champaign County Board of Review's decision is here. I'll get a link to the Illinois Department of Revenue's decision as soon as I can find it.

Catholic nonprofit hospital fights to regain tax exemption in Illinois.

The big news before the recent rash of hearings into and lawsuits against tax-exempts was the decision by Illinois' Department of Revenue affirming the Champaign County Board of Review's determination that the Provena Covenant Medical Center in Urbana was not sufficiently charitable in its operations and no longer deserved to be exempt from local property taxes. The saga is described today in a Wall Street Journal article (requires paid subscription). The Champaign News-Gazette ran a good summary of the case in February after the Department of Revenue handed down its decision. An earlier WSJ article is also available on the web page of the Association of Healthcare Philanthropy.

U.S. health care outcomes compare poorly with other developed nations.

Bob Herbert, in his column in today's N.Y. Times, with a substantial assist from the research of Dr. Barbara Starfield at Johns Hopkins, documents the comparative rankings of this country's health outcomes (e.g., low birth weight percentages, neonatal mortality, infant mortality, life expectancy at age 1 and at age 15):

"Of 13 countries in a recent comparison, the United States ranks an average of 12th (second from the bottom) for 16 available health indicators."

[Dr. Starfield] said the U.S. came in 13th, dead last, in terms of low birth weight percentages; 13th for neonatal mortality and infant mortality over all; 13th for years of potential life lost (excluding external causes); 11th for life expectancy at the age of 1 for females and 12th for males; and 10th for life expectancy at the age of 15 for females and 12th for males.

The standard rejoinder is that the U.S.'s relatively poor showing in such comparisons is not a direct result of a poor health care delivery system but instead is due to the effects of poverty, differences in educational opportunities, and similar "background" effects that can't be cured by the health care system. At some point, however, our leaders (and those, like John Kerry, who aspire to be) need to come to grips with the organization, finance, and delivery of health care in this country. We have the most technically advanced health care in the world, and centers of excellence widely distributed across the country. But that doesn't translate into access and affordability:

The U.S. has the most expensive health care system on the planet, but millions of Americans without access to care die from illnesses that could have been successfully treated if diagnosed in time. Poor people line up at emergency rooms for care that should be provided in a doctor's office or clinic. Each year tens of thousands of men, women and children die from medical errors and many more are maimed. . . .

To get a sense of just how backward we're becoming on these matters, consider that in places like Texas, Florida and Mississippi the politicians are dreaming up new ways to remove the protective cloak of health coverage from children, the elderly and the poor. Texas and Florida have been pulling the plug on coverage for low-income kids. And Mississippi recently approved the deepest cut in Medicaid eligibility for senior citizens and the disabled that has ever been approved anywhere in the U.S.

Even the affluent are finding it more difficult to obtain access to care. For patients with insurance the route to treatment is often a confusing maze of gatekeepers and maddening regulations. The costs of insurance are shifting from employers to employees, and important health decisions are increasingly being made by bureaucrats and pitchmen interested solely in profits.

In the maddening din that passes for a national conversation in this country, distinguished voices like Dr. Starfield's are not easily heard.

Echoing so many other patient advocates, she continues to call for movement on two crucial needs: coverage for the many millions who currently do not have access to care, and the development of a first-rate primary care system, which would bring a sense of coherence to a health care environment that is both chaotic and wildly expensive.

Maybe the reforms described recently by Porter and Teisberg in the May-June Harvard Business Review are the way to go, though I see precious little in their proposal that directly addresses the uninsured, and primary care is only obliquely addressed.

Hospital billing practices reviewed.

It's an old and familiar story for anyone with any experience as a physician, pharmacist, hospital exec, patient, or patient's parent or spouse. (Have I left out anyone?) Routine, 2-hour surgery is billed at $25,652.14, with 4-figure charges for mysteriously named items, astronomical pricing codes for everyday items (the medical equivalent of the Defense Department's $700 hammer), and plain old everyday errors. It's described in a story in yesterday's Washington Post, which relates billing practices to, among other things, the Congressional inquiries into nonprofit hospitals' business practices and the recent class action lawsuits challenging the nonprofits' record in providing charity care (more on these developments here).

Latest marketing ploy from Big Pharm?

As reported in today's N.Y. Times (requires paid subscription), Schering-Plough's been sending 5- and 6-figure checks, unbidden, to physicians "in exchange for an attached 'consulting' agreement that required nothing other than his commitment to prescribe the company's medicines." (Kind of makes you nostalgic for the days when they thought they could buy the loyalty of physicians for the price of a lobster salad lunch once a month.) According to the article, there are several federal investigations looking into the marketing practices of several large drug companies (e.g., Johnson & Johnson, Wyeth and Bristol-Myers Squibb), including a Boston-based look into Schering-Plough.

The article interviewed 20 physicians about the details of the Schering-Plough scheme:

Schering-Plough's tactics, these people said, included paying doctors large sums to prescribe its drug for hepatitis C and to take part in company-sponsored clinical trials that were little more than thinly disguised marketing efforts that required little effort on the doctors' part. Doctors who demonstrated disloyalty by testing other company's drugs, or even talking favorably about them, risked being barred from the Schering-Plough money stream.

Makes you wonder about the company's view of the Medicare anti-kickback law (42 U.S.C. § 1320a-7b(b)), the marketing rules published two years ago by the industry's trade association, PhRMA, and DHHS/OIG's "Compliance Guidance for Pharmaceutical Manufacturers."

William Jewell College (Liberty, MO) adds bioethics major.

William Jewell College, according to a recent AP story (via the Lawrence (KS) Journal-World), has added a bioethics major. Two features of the story seem especially noteworthy:

• Kansas City planners see the major as an important phase in the emergence of KC as a biomedical research center: "The major will include study in biology, chemistry, and religion and philosophy, and it's being introduced as the Kansas City area positions itself to become a hub for biomedical research.
  
  "The Center for Practical Bioethics is in Kansas City, as is the Stowers Institute for Medical Research.
  
  "'I don't think there is any question it will be synergistic,' said Bill Duncan, president of the Kansas City Area Life Sciences Institute."
  
  As Dallas strives to establish itself as the Southwest's biomedical research center, it doesn't seem to have occurred to the powers that be that all this state-of-the-art research just might be complemented by an equally world-class ethics program.



• Best quote: "'I don't see it leading to great employability,' said Bill Bondeson, a medical ethics professor at the University of Missouri in Columbia," in response to William Jewell's reported "hope[] that its graduates will find a ready market for their degrees."

Professor Bill is undoubtedly correct, but if I were a medical-school admissions officer, a grad with this major would probably rocket right to the top of the list.

AMA beating the med-mal crisis drum loudly.

N.Y. Times op-editorialist Bob Herbert has followed up on last Monday's column with another swipe at those who claim that soaring med mal insurance premiums are the result of massive incrases in med mal payouts. This time, though, it's the AMA who gets rapped for feeding the frenzy. Claiming that 20 states are now in a med-mal insurance crisis (up from 12 in 2002), the AMA has conveniently mapped out the whole country for all to see which states are in crisis, which ones are showing problem signs, and which states are "currently okay" (apparently only 6 states are in this last category). An interactive version of the map, with anecdotes, a smattering of statistics, and a description of the current state of the health-care liability laws, can be found here.

In today's column, Herbert claims that the evidence has been misstated or skewed by the AMA, at least as respects Missouri, Florida, and New Jersey. I'd add Texas to the list of so-called crisis states where the evidence seems to point to the opposite conclusion. After the surge of filings to beat the September 1, 2003, effective date of our med-mal reform statute, new filings seem to have virtually dried up. There's been little or no reduction in premiums in tort-reformed states, though, and I am betting (with Bob Herbert) that the docs have been sold a bill of goods about the causes (and cures) for their insurance-premium crisis. For more information, and a slightly more balanced view, check out the GAO report on the alleged med-mal crisis, discussed here last August 1.

Parkland: public hospital blues.

The Dallas Morning News' Sherry Jacobson has been doing a fine job in two recent pieces (6/23, 6/24) covering Parkland's financial woes. Bottom line: Parkland's caught in The Big Squeeze: Federal law requires the hospital to provide emergency medical care to anyone who needs it, regardless of their county (our country) of residence. But state law requires other counties to reimburse Dallas only for care provided to indigents. And each county gets to define "indigency" as it sees fit. So Collin County, which long ago decided it did not want to tax its own residents for indigent health care, has defined indigency to top out at about $4,000 a year for a family of four (about 1/4 the federal definition of poverty). Any Collin County resident making more than that gets treated by Parkland at Dallas County's expense. What is wrong with this picture?

Discounting bills for uninsured patients: not as easy as it sounds.

The Wall Street Journal ran a good article (subscription required) Thursday on the difficult choices faces by hospital administrators when uninsured patients rack up hefty bills: Who should get a discount? And how much of the bill should be written off? Uninsured patients come in all shapes and sizes, and hospital policies are only a starting point for making the hard choices posed by uninsured patients.

More on tax-exemptions.

I particularly recommend a recent (June 22) publication by the staff of the Joint Committee on Taxation entitled "Description of Present Law Relating to Charitable and Other Exempt Organizations and Statistical Information Regarding Growth and Oversight of the Tax-Exempt Sector." It's a good overview of the tax-exempt industry and horn-book style overview of the legal basics.

Tax-exempt orgs much in the news.

There's a lot of scrutiny of tax-exempt organizations these days, much of it on the health care industry, and all of it of potential significance to tax-exempt health care providers. Here's a quick run-down of yesterday's developments:

• Richard Scruggs announced yesterday that he (or related firms) has filed 5 more class-action suits against 8 more defendants challenging the amount of charity care the defendants provide. The press release is on a litigation web page here, along with copies of all 18 complaints. As Charles Bailey, g.c. of the Texas Hospital Association, said in an article in The Dallas Morning News, it's surprising that two hospitals (so far) in Texas have been targeted, since Texas requires nonprofit hospitals to provide a minimum amount of charity care in order to maintain their nonprofit status. The "safe harbor" requirement is 4% of net operating revenues for charity care and unreimbursed govern-sponsored indigent health care and 5% in total community benefits.
• The Senate Finance Committee began hearings under the title, "Charity Oversight and Reform: Keeping Bad Things from Happening to Good Charities." There were three panels and a total of 13 witnesses, not counting Senators Grassley and Baucus, who presented their own member statements. The hearing can be viewed with streaming video through RealAudio. There's also a 19-page "staff discussion draft" of Tax Exempt Governance Proposals, if you want to see where these hearings are headed.
• The IRS announced at the Senate hearing that it is launching an enforcement initiative to examine compensation practices of tax-exempt and charitable organizations. You can read the details in Commissioner Everson's testimony or you can read about it in this AP article (via The Houston Chronicle).
• Over on the House side, the Oversight Subcommittee of the House Ways and Means Committee held its "First Hearing in a Series on Tax Exemption: Pricing Practices of Hospitals": two panels, nine witnesses. There's a good AP report (via Forbes.com) on the House hearings.

Not-for-profit litigation.

More suits were filed today against some health care giants, including Catholic Health Initiative and Baylor Health Care System. Here's a more stable link to the web page where the pleadings can be found: http://www.nfplitigation.com/NotForProfit/disclaimer.aspx.

Unpublished (i.e., negative) clinical trial results.

While I pondered how to blog this topic efficiently, along came the folks at Kaiser Family Foundation with a characteristically terrific summary of three recent newspaper reports on this important topic. If NY Attorney General Eliot Spitzer is right about this, GlaxoSmithKline's decision to withhold negative research results about the side effect of the antidepressant Paxil in children "the . . . studies . . . failed to demonstrate that Paxil is effective and . . . suggested a possible increased risk of suicidal thinking and acts."

Supreme Court: ERISA preempts state-law claim against HMOs.

As expected, the Supreme Court today decided that ERISA does, in fact, preempt the tort-like cause of action created by the Texas legislature in the Texas Health Care Liability Act, at least as against HMO's providing health care coverage through an employer. Indeed, the cause of action is completely preempted (§ 502(a)(1)(B)), so ERISA not only provides a defense, it also creates a basis for removal of the state-law claims from state court to federal court. This is a technical issue, and if you haven't been following it pretty closely, consider going to a news site like Bloomberg's or Reuter's for the 5¢ version. The 25¢ version is in the Court's syllabus (below). For all the gory details, you can read the unanimous opinion in Aetna Health Inc. v. Davila, No. 02-1845 (combined with CIGNA HealthCare of Texas, Inc. v. Calad, No. 03-83) here.

The Court's syllabus:

Respondents brought separate Texas state-court suits, alleging that petitioners, their health maintenance organizations (HMOs), had refused to cover certain medical services in violation of an HMO’s duty “to exercise ordinary care” under the Texas Health Care Liability Act (THCLA), and that those refusals “proximately caused” respondents’ injuries. Petitioners removed the cases to federal courts, claiming that the actions fit within the scope of, and were thus completely pre-empted by, §502 of the Employee Retirement Income Security Act of 1974 (ERISA). The District Courts agreed, declined to remand the cases to state court, and dismissed the complaints with prejudice after respondents refused to amend them to bring explicit ERISA claims. Consolidating these and other cases, the Fifth Circuit reversed. It found that respondents’ claims did not fall under ERISA §502(a)(2), which allows suit against a plan fiduciary for breaches of fiduciary duty to the plan, because petitioners were being sued for mixed eligibility and treatment decisions that were not fiduciary in nature, see Pegram v. Herdrich, 530 U.S. 211; and did not fall within the scope of §502(a)(1)(B), which provides a cause of action for the recovery of wrongfully denied benefits, because THCLA did not duplicate that cause of action, see Rush Prudential HMO, Inc. v. Moran, 536 U.S. 355.

Held: Respondents’ state causes of action fall within ERISA §502(a)(1)(B), and are therefore completely pre-empted by ERISA §502 and removable to federal court.

(a) When a federal statute completely pre-empts a state-law cause of action, the state claim can be removed. See Beneficial Nat. Bank v. Anderson, 539 U.S. 1, 8. ERISA is such a statute. Because its purpose is to provide a uniform regulatory regime, ERISA includes expansive pre-emption provisions, such an ERISA §502(a)’s integrated enforcement mechanism, which are intended to ensure that employee benefit plan regulation is “exclusively a federal concern,” Alessi v. Raybestos&nbhyph;Manhattan, Inc., 451 U.S. 504, 523. Any state-law cause of action that duplicates, supplements, or supplants ERISA’s civil enforcement remedy conflicts with clear congressional intent to make that remedy exclusive, and is therefore pre-empted. ERISA §502(a)’s pre-emptive force is still stronger. Since ERISA §502(a)(1)(B)’s pre-emptive force mirrors that of §301 of the Labor Management Relations Act, 1947, Metropolitan Life Ins. Co. v. Taylor, 481 U.S. 58, 65—66, and since §301 converts state causes of actions into federal ones for purposes of determining the propriety of removal, so too does ERISA §502(a)(1)(B).

(b) If an individual, at some point in time, could have brought his claim under ERISA §502(a)(1)(B), and where no other independent legal duty is implicated by a defendant’s actions, then the individual’s cause of action is completely pre-empted by ERISA §502(a)(1)(B). Respondents brought suit only to rectify wrongful benefits denials, and their only relationship with petitioners is petitioners’ partial administration of their ERISA-regulated benefit plans; respondents therefore could have brought §502(a)(1)(B) claims to recover the allegedly wrongfully denied benefits. Both respondents allege violations of the THCLA’s duty of ordinary care, which they claim is entirely independent of any ERISA duty or the employee benefits plans at issue. However, respondents’ claims do not arise independently of ERISA or the plan terms. If a managed care entity correctly concluded that, under the relevant plan’s terms, a particular treatment was not covered, the plan’s failure to cover the requested treatment would be the proximate cause of any injury arising from the denial. More significantly, the THCLA provides that a managed care entity is not subject to THCLA liability if it denies coverage for a treatment not covered by the plan it administers.

(c) The Fifth Circuit’s reasons for reaching its contrary conclusion are all erroneous. First, it found significant that respondents asserted tort, rather than contract, claims and that they were not seeking reimbursement for benefits denied. However, distinguishing between pre-empted and non-pre-empted claims based on the particular label affixed to them would allow parties to evade ERISA’s pre-emptive scope simply by relabeling contract claims as claims for tortious breach of contracts. And the fact that a state cause of action attempts to authorize remedies beyond those that ERISA §502(a) authorizes does not put it outside the scope of ERISA’s civil enforcement mechanism. See, e.g., Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41, 43. Second, the court believed the plans’ wording immaterial because the claims invoked an external ordinary care duty, but the wording is material to the state causes of action and the THCLA creates a duty that is not external to respondents’ rights under their respective plans. Finally, nowhere in Rush Prudential did this Court suggest that ERISA §502(a)’s pre-emptive force is limited to state causes of action that precisely duplicate an ERISA §502(a) cause. Nor would it be consistent with this Court’s precedent to do so.

(d) Also unavailing is respondents’ argument that the THCLA is a law regulating insurance that is saved from pre-emption by ERISA §514(b)(2)(A). This Court’s understanding of §514(b)(2)(A) is informed by the overpowering federal policy embodied in ERISA §502(a), which is intended to create an exclusive federal remedy, Pilot Life, 481 U.S., at 52. Allowing respondents to proceed with their state-law suits would “pose an obstacle” to that objective. Ibid.

(e) Pegram’s holding that an HMO is not intended to be treated as a fiduciary to the extent that it makes mixed eligibility decisions acting through its physicians is not implicated here because petitioners’ coverage decisions are pure eligibility decisions. A benefit determination under ERISA is part and parcel of the ordinary fiduciary responsibilities connected to the administration of a plan. That it is infused with medical judgments does not alter this result. Pegram itself recognized this principle, see 530 U.S., at 231—232. And ERISA and its implementing regulations confirm this interpretation. Here, petitioners are neither respondents’ treating physicians nor those physicians’ employees.

307 F.3d 298, reversed and remanded.

This case had to come out the way it did. The Fifth Circuit's attempt to distinguish the THCLA cause of action against HMO's from the types of claims previously determined by the Supreme Court to be preempted by ERISA was completely off the wall.

That's not to say that the HMO's shouldn't be held accountable for their mistakes, nor that the ERISA remedy is, in many cases, a cruel joke. But existing Supreme Court interpretations of existing ERISA language leave little or no room for such an outcome. So the ball is squarely back in Congress' lap to make changes to ERISA, though its repeated failures to do so in its previous attempts gives little encouragement that they will be able pull off such a miracle, especially in an election year.

Living wills under fire.

It sounds like the old rap on living wills is being recycled. According to an article in the June 21 Newsday, experts are weighing in on the disutility of living wills. The old rap: (1) Writers of living wills have a hard time predicting with any precision the diagnosis and treatment options that will be their actual end-of-life reality, and so the document has almost no chance of addressing the actual decisions their surrogate decision makers will be confronted with. (2) Considering the imprecision of patient predictions, as well as the limits of language, living wills present sometimes insurmountable interpretive difficulties. (3) And in any event, hospitals seldom know about the existence of a patient's living will until after life-sustaining treatment has been started. In brief: living wills are often too little, too late.

The new rap:

Recently, two University of Michigan researchers, writing in the bimonthly Hastings Center Report, a journal that examines issues in medical ethics, concluded that living wills are useless.

"It's very hard for people to predict their preferences for an unknown health condition," said Angela Fagerlin, a research scientist and co-author of the article. In addition, "decision makers have a difficult time interpreting [living wills]," Fagerlin said.

And Carl Schneider, a law professor and Fagerlin's co-author, says: "In lots of ways, the unsolvable problem is that writing down your intentions clearly is a lot harder than people think it is."

Sound familiar?

Fact is, living wills were never the end-all and be-all of end-of-life decision making, but the weaknesses of the document can be overdrawn. They help the executor and her family get into a discussion mode that will help end-of-life decision making when the time comes. They can, therefore, help surrogate decision makers -- including those holding a medical power of attorney -- take on the emotion and psychological burden of decision making.

Would we be in a world of hurt if living wills were eliminated? No. Can their utility be over-estimated? Sure. But do they serve a potentially valuable function? I think so.

Med mal reform: speaking truth to power.

Bob Herbert nails the problem with med mal reform in the last third of an 800-word column that will appear in this morning's (6/21) N.Y. Times:

[T]he problem when it comes to malpractice is not the amount of money the insurance companies are making (they're doing fine) or the rates the doctors have to pay, but rather the terrible physical and emotional damage that is done to so many unsuspecting patients who fall into the hands of careless or incompetent medical personnel.

What is needed is a nationwide crackdown on malpractice, not a campaign to roll back the rights of patients who are injured. This is another utterly typical example of the Bush administration going to bat for those who are economically and politically powerful against those who are economically and politically weak.

Despite claims by the insurance industry, there is no evidence that soaring malpractice premiums are the result of sharp increases in the amounts of money paid out for malpractice claims. And, tellingly, industry executives are generally careful not to say that the tort reforms sought by the Bush administration will result in premium reductions.

This is all about greed. What tort reform will lead to, not surprisingly, is an unwarranted burst of additional profits for the insurance industry, which is why the industry is sinking so much money into its unrelenting campaign for "reform."

It would be helpful if the nation's many good doctors would blow the whistle on the insurance industry and its exploitive practices, and on the members of their own august profession who violate that essential maxim, "First, do no harm."

Boutique medicine comes to the Hamptons, big-time.

I've written about boutique medicine elsewhere (5Aug03, 14Aug03) - the practice by which a physician or group will charge an annual premium in return for which they will promise to return calls promptly, not keep the patient waiting in the waiting room, and generally provide the quality of care dinosaurs like me remember from the '50's. Today's N.Y. Times has an interesting opinion piece on the practice, but with a twist. Now it's a local hospital that's going boutique, and it's the emergency room where the rich are going to catch a break, if they've already paid the upfront fee. As the paper reports,

The 95-year-old financially ailing Southampton Hospital - the only serious medical emergency center on the South Fork - is offering a plan aimed at wealthy summer visitors whose primary doctors are back in Manhattan and out of reach, presumably along with the hospital's sense of propriety. For $6,000 per family, or $3,800 for individuals, not including doctors' fees, cardholders in the Southampton PLUS plan are entitled to "priority access" to medical care at the hospital from May 28 to Sept. 26. A brochure about the plan was mailed to several thousand summer homeowners from a mailing list the hospital purchased from a source it declined to identify.

Southampton Hospital lets you know that it understands what a drag all this messy medical stuff can be when you're on a busy summer weekend, careening from tennis lesson to benefit to cocktail party with nary a moment to waste sitting around a hospital emergency room. Since "a visit to the emergency department is gut-wrenching enough without the added frustration of filing out multiple forms," the brochure commiserates, PLUS members are pre-registered, which includes being met at the door of the hospital "by a member of the hospital's senior staff." The brochure confides, "You shouldn't have to wait around where your health is concerned,'' and adds, "While we can't guarantee you'll be seen first, we'll do everything possible to get you in and out fast." The plan covers not only family members, but also weekend house guests and "hired help," as the brochure so quaintly describes what must be the au pair.

The PLUS plan motto? "Peace of mind, all summer long." That is, if you're flush.

As the author points out, and the hospital has lately realized, "[i]t is, of course, illegal to give someone priority for medical care because of a cash payment in an emergency room. Since the controversial brochure was mailed, hospital officials have gone to great pains to say that PLUS plan members will have to wait their turn in line with hoi polloi. The plan has been greeted with howls of protest from local doctors, including a Southampton Hospital admitting doctor, Robert Semlear, who told a local newspaper he found the PLUS program 'morally repugnant' and 'elitist.'"

Testing for fetal defects.

Good article in today's N.Y. Times on testing for fetal defects. The ethical issue is an interesting one, succinctly described in the article this way:

The wider range and earlier timing of prenatal tests are raising concern among some bioethicists and advocates for disability rights who argue that the medical establishment is sending a message to patients that the goal is to guard against the birth of children with disabilities.

"By putting them out there as something everyone must do, the profession communicates that these are conditions that everyone must avoid," said Adrienne Asch, a bioethicist at Wellesley College. "And the earlier you can get it done the more you can get away with because you never have to tell anybody."

Some doctors, too, say they are troubled by what sometimes seems like a slippery slope from prenatal science to eugenics. The problem, though, is where to draw the line.

Mixing Morals With Education?

Well, as a teacher of bioethics at a Methodist school with a Center for Ethics and Public Responsibility, the debate over whether ethics has any place in a higher education curriculum is, to put it mildly, more than mildly interesting. The debate is set out well in Saturday's "Beliefs" column by Peter Steinfels in The New York Times.

Episcopal Diocese of Vermont issues guidelines for civil-union sacrament.

As reported in today's Washington Post, a task force of the Episcopal Diocese of Vermont issued a report on June 8 setting out the guidelines for ceremonies that recognize same-sex civil unions. The document itself includes a thoughtful analysis of the scriptural and theological underpinnings of the blessing of same-sex relationships. Vermont isn't the only diocese to take this step, but it is the only diocese in which the state recognizes same-sex civil unions, and the combination of sacramental recognition and governmental recognition has conservatives within the Episcopal Church USA upset -- as does the striking similarities between the marriage sacrament and the civil-union sacrament.

Of course, the real cause for the conservatives' concern is not Vermont, it is their own General Convention, which in 2003 adopted a resolution that stopped short of authorizing an official liturgy for blessing same-sex relationships but did recognize that "local faith communities are operating within the bounds of our common life as they explore and experience liturgies celebrating and blessing same-sex unions." This all traces back to the controversial resolution adopted at the 2000 General Convention that, in the words of the Vermont task force's report,

that couples “in the Body of Christ and in this Church” are living both in marriage and in “other life-long committed relationships.” The resolution stated the expectation that “such relationships will be characterized by fidelity, monogamy, mutual affection and respect, careful, honest communication, and the holy love which enables those in such relationships to see in each other the image of God.” The resolution further said that “this Church intends to hold all its members accountable to these values and will provide for them the prayerful support, encouragement and pastoral care necessary to live faithfully by them.”

The Vermont task force's report is a strong and even inspirational document. Pages 9 to 15 summarize the Anglican case for sacramental recognition of same-sex relationships, and it includes -- of special interest to lawyers, I suppose -- a statement of principles of interpretation of scripture.

The parallels are striking between (i) the current debate over the immutability of the Constitution as a text with permanent and unchanging meaning handed down from divinely inspired authors, and (ii) the Anglican debate over the immutability of scripture as a text with permanent and unchanging meaning handed down from divinely inspired authors. The tensions -- between constitutional and scriptural faith, reason, and experience -- are age-old, both within the body politic of the United States and within the worldwide Anglican Communion. The Vermont report strikes an admirable balance that embraces experience and reason within a faith tradition:

Putting it perhaps too simply, one strand of Anglicanism -— the evangelical tradition —- has emphasized the authority of scripture, and some, but not all, among them have insisted on a more literalist reading of the Bible. Another strand -— the Anglo-Catholic tradition -— has emphasized the authority of the early church, and some, but not all, of them have resisted subsequent development of doctrine and practice. Many other strands lying between these two have looked to reason -— including to a greater or lesser extent, experience —- to mediate scripture and the tradition in light of the learning of science and culture.

All these strands, or traditions, of Christian living and believing have been embraced within Anglicanism, and they have remained in a lively tension, informing, enriching, and sometimes conflicting with one another. Each has had times or places in which it held greater influence than the others, but none has been able to claim that it was the tradition, exclusive of the others. We speak of “Anglican comprehensiveness,” or Anglicanism as the “via media,” not because we are wishy-washy or overly inclined to compromise basic principles, but because we value the ultimate goal of Christian unity and St. Paul’s understanding of the Body of Christ, in which no part may say to the other, “I have no need of you.”

“Doing” Anglican theology means taking Holy Scripture seriously as the primary source of our understanding of Christian faith. It means being consistent with the major creedal and doctrinal conclusions of the early church. It means honoring our liturgical tradition. And it means using our human capacity to learn about our world and to bring that learning into conversation with scripture and theological and liturgical tradition. We believe this is a dynamic and ongoing process in which we must always seek to be open to the guidance of the Holy Spirit.

Apart from the wise discussion of interpretations of authoritative texts, the Vermont report has at least one other thing to offer the current debate over the legal status of same-sex relationships: "One reality we want to highlight is the fact that many people often have a visceral response to same-gender relationships but cloak that response with intellectual or sentimental language. 'Head' and 'heart' language attempts to disguise what the 'gut' is saying." The report continues:

Let us be honest about our gut reactions. Ours is a culture in which people have widely divergent views about human sexuality and human intimacy. Mixed messages are common, and we internalize these mixed messages in varying degrees as we grow up. The culture both glorifies sexuality and conditions us to see sexual activity as “unclean” unless confined to particular circumstances. For some, any sexual intimacy evokes an “ick response.” For many, sexual intimacy between persons of the same gender evokes an “ick response.” However, there are some among us who find their most essential, God-given identities fulfilled in an intimate relationship with a person of the same gender. The “ick response” to sexual intimacy comes less from the head and heart and more from the gut; it involuntarily occurs within us. . . .

Another reality is that the Bible has been commonly understood to be unrelentingly opposed to same-sex sexual activity. We acknowledge that today there is genuine disagreement on these matters among faithful Christians who hold scripture in the highest regard. Our Anglican reliance on tradition and reason as means of informing our interpretation of scripture offers a way to bring head, heart and gut into fruitful and respectful conversation.

Would that our policy-makers on courts and in legislatures could learn from this report's wise words.

Complaints in the not-for-profit class actions.

The complaints in the NFP/charity-care cases mentioned here Thursday are here. [Update: that link now prompts you for a password. This link is better; it will take you to a home page that leads to the pleadings.] It looks as though the plan is for all litigation documents to be posted on this web site.

The Texas complaint (against East Texas Medical Center and related entities) is 22 pages long and is an amateurish job. The complaint alleges the breach of numerous express and implied contracts with the federal, state, and local governments (in return for tax exempt status)(Count 1); the breach of related duties of good faith and fair dealing (Count 2); violations of the Texas DTPA (Count 3); unjust enrichment/constructive trust (Count 5 - there is no Count 4 -- and only the unjustment enrichment part is a separate "count"; everything else (request for constructive trust and vague request for damages) belongs in the "Relief" section); and civil conspiracy and "concert in [or sometimes "of"] action (Count 6). The complaint seeks various forms of declaratory and injunctive relief (erroneously denominated Count 8 rather than beling listed under a separate heading for "Relief" - and there is no Count 7), as well as damages and the imposition of a constructive trust. Considering how much is allegedly at stake, you'd have thought this big-time class-action firm might have drafted the complaint with a little more care.

Right off the bat, expect the federal district court's subject-matter jurisdiction to be challenged. The complaint alleges the existence of general federal-question jurisdiction (28 USC § 1331) because of the existence of a contract with the federal government based upon the defendants' tax-exempt status. (What contract? And in any event, since when does a breach of contract claim state a federal question?) The complaint also bases jurisdiction on 28 USC § 1340, which gives federal district courts jurisdiction of any civil action arising under, among other things, the Internal Revenue Code. (This is the provision that gives jurisdiction over taxpayers' suits for refunds when they contest a tax bill; it will be interesting to see whether the court believes that it extends jurisdiction to the claims of former patients who complain of collection efforts by the hospital, allegedly in violation of the hospital's duty (pursuant to 26 USC § 501(c)(3)) to leave them alone.)

On the merits, the complaint is very strange. It is premised on the belief that a tax-exempt hospital shouldn't bill for services, or shouldn't try to collect on its bills, or shouldn't try very hard to collect on its bills. This is a strange conception of tax-exempt organizations. Indeed, if a tax-exempt hospital didn't try all reasonable means to collect on its bills, it might find its tax exemption in jeopardy ("private benefit") and the state Attorney General at its door (looking into the dissipation of assets held in a "public trust"). Okay, that last idea is a bit far-fetched, but less so than the allegation that tax-exempt hospitals shouldn't be run in a business-like manner. Among other things, donors might be more than a little concerned that their generosity is being used to fund the care of those who can pay, leaving less money to pay for the care of those who cannot pay. And how does a hospital figure out who can and cannot pay? By trying to collect from anyone who has not previously established their indigent status.

This is going to be interesting . . . . Unfortunately, it's also going to be expensive to defend this pointless lawsuit. What a waste.

If it can happen to Harvard . . .

Alice Dembner reports in today's Business section of The Boston Globe that Harvard University and Beth Israel Deaconess Hospital "will pay $2.4 million to settle allegations that they misused four federal research and training grants, improperly billing the government for salaries and expenses, the US attorney's office said yesterday." Universities and teaching hospitals around the country need to wake up and smell the coffee. Regardless of the source of the federal grant money -- NIH, NSF, you name it -- the era of playing games with the actual use to which funds are put is over:

[T]he agreement specifically leaves open the possibility of further action against Dr. Jeanne Wei, the geriatrician who was the principal investigator for the grants. The agreement also requires the institutions to cooperate with "the government's investigation of individuals" involved with the four grants.

Wei, the former head of Harvard's division on aging and Beth Israel's division of gerontology, resigned from those administrative posts in 1999 and left Harvard Medical School and the hospital in June 2002. She is currently a professor and executive vice chairman of the geriatrics department at the University of Arkansas for Medical Sciences. She did not respond to a request for comment yesterday.

"This settlement should send a message that institutions who accept federal grant money, no matter who they are, must strictly adhere to the terms and conditions of those grants," said US Attorney Michael J. Sullivan in a statement.

The press release from the U.S. Attorney's office details the misuse:

• salaries of physician scientists who did not work on the grant;
• salaries of physician scientists who did not meet the citizenship requirements of the grant;
• the salary of a physician scientist who did not meet the 75% effort requirement of the grant; and
• salary expenses of the Principal Investigator in excess of the budgeted amount;
• supply and equipment expenses incurred in connection with other projects not related to the grant, and expenses incurred by physician scientists who were not eligible to work on the grant or did not work on the grant; and
• expenses related to the use of research animals that were used for other projects not related to the grant or were used by physician scientists who were not eligible to work on the grant.

The use of the federal False Claims Act is particularly noteworthy for those school officers who may not think compliance is a big deal. Anyone with knowledge of the wrong-doing can bring a whistleblower (or "qui tam") action under 37 U.S.C. §§ 3729-3730, and if the fraud is proved, the whistleblower (technically, "the qui tam relator") almost always shares in the government's recovery, which may be up to two times the amount of damages actually sustained by the government. The whistleblower's share may be 15-25% of the recovery if the government took over the litigation of the suit, or 25-30% is the government declined to litigate the claim and the qui tam relator had to go it alone. In the Harvard/Deaconess case, if there had been a qui tam relator (which it appears there was not), her share (if she'd litigated without the government's assistance) would have been as high as $720,000. Small wonder that private qui tam actions under the False Claims Act constitute one of the fastest-growing areas of federal litigation around. (The Fried Frank firm's web page is a great resource for information about the Civil War-era statute and the litigation it has spawned.) And all the more reason why large grant recipients who don't invest in a compliance officer to make sure they stay clean are penny wise and pound foolish.

Nonprofit hospitals targeted for charging premium prices needy patients.

UPI has filed a story based upon an earlier Wall Street Journal report (requires paid subscription) about a series of suits -- with more to come -- against nonprofit hospitals:

Richard Scruggs, the Mississippi lawyer whose legal attack on the tobacco industry helped bring about historic changes -- and multibillion-dollar settlements -- is setting his sights on not-for-profit hospitals which he alleges are overcharging uninsured patients and subjecting some to harsh bill-collection tactics.

Late yesterday, Mr. Scruggs and other lawyers -- including some who collaborated with him on the tobacco litigation -- filed class-action suits in federal courts in eight states against about a dozen not-for-profit hospital systems, challenging whether those institutions deserve the tax exemptions they have enjoyed for so long.

The complaints have minor variations, but all are essentially breach-of-contract suits, centered around the notion that not-for-profit hospitals have an explicit or implicit contract with the government to treat needy patients with compassion in return for significant tax breaks. The suits argue that the hospitals have violated that contract by charging uninsured patients premium prices, while they negotiate deep discounts with insurers, HMOs and government programs such as Medicare and Medicaid. Some hospitals go further and use tough tactics to collect unpaid bills, including sometimes placing liens on homes and assessing interest, fines and legal fees.

According the Modern Healthcare's Daily Dose (requires paid subscription), "[t]he charges include breaches of charitable trust, consumer fraud, deceptive business practices, unjust enrichment, and violations of the Emergency Medical Treatment and Active Labor Act."

Think there's any connection between these suits and the letter from Tommy Thompson, Secretary of DHHS, to the president of the American Hospital Association last February, essentially scolding the AHA for suggesting that DHHS rules prohibit hospitals from charging indigent patients less than the full billed charge for hospital services?

Antitrust and hospital consolidations.

In a late-afternoon report today, Modern Healthcare's Mark Taylor wrote that "the American Hospital Association delivered a 17-page letter to the Federal Trade Commission and the Justice Department's antitrust division rejecting hospital consolidation as a key driver of healthcare costs and pleading for a review of health insurers' conduct. The AHA's letter anticipates the expected release this summer of the FTC and Justice Department's joint report on their two years of hearings on healthcare competition." After reading the analysis piece in the Harvard Business Review by Michael E. Porter and Elizabeth Olmstead Teisberg, it is hard to see how a sentient human being can argue that consolidations haven't had an impact on both health care costs and quality.

AMA resolution to allow denial of care to plaintiffs' lawyers and families.

I discussed this resolution here last week, and today the N.Y. Times reports that the resolution filed by Dr. J. Chris Hawk III "drew an angry response from colleagues on Sunday at the annual meeting of the association. Many doctors stood up to denounce the resolution in passionate speeches - even after its sponsor . . . asked that it be withdrawn."