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).

ER care being triaged at University of Colo. Hosp. in Boulder.

It doesn't seem like much of a story until you read the details. But, acording to a piece in today's Washington Post, hospitals like the University of Colorado Hospital are no longer providing unreimbursed nonemergency care through their ER. The change is potentially enormous.

To begin with: "As the provider of last resort, hospital emergency departments across America have for decades accepted thousands of truly non-urgent cases and swallowed the cost. For the most part, the patients have nowhere else to go, no insurance and no money." In other words, ER patients with subacute conditions typically got triaged over to the nonemergent ER desk, where their sore throats and sprains were handled. If the bill was never paid, that was just a fact of life. No more. Now they are triaged out to another facility.

Beyond this change, the ERs are treating nonemergent ferently depending upon their financial ability to pay. Nonemergent cases will continue to be seen, as long as there's insurance coverage for that service or -- because most health plans will deny coverage of nonemergency services in the ER -- the patient has cash.

Whether this is a good thing (i.e., hospitals finally taking control of their emergency departments and running them a little more like a business) or not remains a hotly debated issue.

At least judging from the article, there is a chance that patients who present to the ER with a request for emergency services will get a cursory review, rather than a "medically appropriate screening," as required by the federal Emergency Medical Treatment and Active Labor Act (EMTALA). Federal officials say that isn't happening at the Univ. of Colo. hospital, but it is obviously a risk. And, apart from the legal liability that flows from an EMTALA violation, there is the added health costs: "'If we tell people don't come to the emergency department unless you're dying, that's exactly what they'll do,' said Arthur Kellermann, a professor at Emory University School of Medicine and chairman of the emergency medicine department at Grady Memorial Hospital in Atlanta. 'If no one else is willing to take care of that diabetic, then we are very unwise to turn that person away,' because chronic conditions tend to worsen if left untreated."

One of perhaps unintended patient benefits of EMTALA was precisely this: patients with chronic or sub-emergent conditions got seen by a doctor or nurse-practitioner/physician's assistant somewhere within the system, and conditions that could have worsened were treated sooner rather than later. The problems with this fix are (1) some ERs are stretched beyond their limits by such cases, which necessitates the diversion of true emergencies away from the ERs, and (2) from a cost standpoint, about the only more expensive (and less appropriate) hospital setting for these subacute patients is the ICU.

The message of the unsurprising story in today's paper is that our country's ER "fix" for unfunded patients (EMTALA) was an admirable attempt to fix the patient of "patient dumping" but was not a good solution -- nor was it really intended to be -- for the problem of inequitable access to health insurance, and it has become unsustainable. This was the message of a Wall Street Journal article last year about similar efforts to cut back on uncompensated care at the University of Texas Medical Branch (UTMB) at Galveston (Bernard Wysocki Jr., "At One Hospital, A Stark Solution For Allocating Care," WSJ, September 23, 2003, at A1) (may require paid subscription). In fact, the WSJ has done a good job on this issue with a series of pieces, from September to December 2003, including:

• Six Prescriptions to Ease Rationing, 12/22/03
• Universal Care Has a Big Price: Patients Wait, 11/12/03
• Longer Dialysis Raises Hopes, but Poses Dilemma, 10/02/03
• Stark Choices at a Texas Hospital, 09/23/03
• Lilly Fuels Debate Over Rationing, 09/18/03
• An Invisible Web of Gatekeepers, 09/16/03
• Health Care's Big Secret: Rationing Is Here, 09/12/03

Meanwhile, a quite useful analysis of the "hidden costs" in the Canadian health care system appeared last week in the WSJ and should be required reading for anyone who thinks health-care financing woes are subject to a quick fix.

The New York Times: "Administration Says a `Zone of Autonomy' Justifies Its Secrecy on Energy Task Force"

Couldn't help noticing this headline in today's Times. Too bad this Administration isn't equally eager to protect the "zone of autonomy" when it comes to the decisional choices of pregnant women, dying patients possessing and using medical marijuana pursuant to doctors' orders that are perfectly legal under California law, physicians who prescribe medications for terminally ill patients pursuant to Oregon's physician-assisted suicide law, and same-sex couples who seek the recognition and protection of a marriage license, just to name a few . . . .

Do poets die young(er)?

According to a study published in the Journal of Death Studies, the answer is yes. (See this Reuters article for the full story). Many news sources reported this story with what seemed to me to be unseemly glee, but no matter. Statistically, it's hard to say whether this study proves anything. Correlation, we all know, is not causation. Thus there are many possible explanations for the correlation. The one that I think is the most interesting was suggested by James Kaufman, the author of the study:

"Poets produce twice as much of their lifetime output in their twenties as novelists do," he said.

So when a budding novelist dies young, few people may notice.

"A great novelist or nonfiction writer who dies at 28 may not have yet produced her or his magnum opus."

Kaufman said poets should not worry, but should perhaps look after their health.

"The fact that a Sylvia Plath ... may die young does not necessarily mean an Introduction to Poetry class should carry a warning that poems may be hazardous to one's health," he said.

Good. Now we can go back to worrying about real health threats, like SARS and the environmental policies of George Bush.

Gov. Romney won't let gay outsiders wed in Massachusetts.

It seems the Bay State has a statute that dates back to 1913 prohibiting out-of-state couples from marrying if their marriage would be void in their home state (see the report in this morning's New York Times). Governor Mitt Romney is directing revisions to local marriage forms so that home states can be identified. Meantime, he plans to write to every governor in the country and ask for assurances that same-sex marriage is permitted in their states. As the Times noted, however:

It seems unlikely that any state would be able to say that at the moment. Thirty-nine states have passed so-called defense-of-marriage acts, which stipulate that marriage is between a man and a woman. Three other states — Maryland, New Hampshire and Wyoming — have laws precluding same-sex marriage. And seven states, including New York, New Jersey and Connecticut, make no specific reference to same-sex couples in their laws.

By my count, that's 49 states that will not recognize same-sex marriage. (Where's D.C. in all this?)

Described by various news reports as "obscure" and "little-known," the 1913 law is easily found in Chapter 207 ("Marriage") of the Domestic Relations Law of the Commonwealth of Massachusetts. The first part of Chapter 207 is entitled "Certain Marriages Prohibited," and Section 11 (of 14 sections) lays it out for all to see:

Section 11. No marriage shall be contracted in this commonwealth by a party residing and intending to continue to reside in another jurisdiction if such marriage would be void if contracted in such other jurisdiction, and every marriage contracted in this commonwealth in violation hereof shall be null and void.

I don't know of many other states with a similar provision, probably because most states are happy to marry 'most anyone who meets the legal requirements of their own state and leave it to the happy couples' home states to figure out whether they will recognize the union or not (depending on whether the marriage violates the public policy of the state). Gov. Romney, on the other hand, is not concerned with enforcing other states' rules about who can marry whom. His worry is that Massachusetts will "become the Las Vegas of same-sex marriage." Considering that all states are perfectly capable of protecting their own interests in traditional marriage without the help of the Commonwealth of Massachusetts, one wonders whether this is really about the proliferation of tacky little white marriage chapels or plain, old-fashioned discrimination.

More medical hoax sites on the WWW

I noted earlier (here and here) the masterful fake cloning Web site in connection with (but with no reference to) the new film, Godsend. Turns out this isn't the first one. Another was posted in connection with Eternal Sunshine of the Spotless Mind (Lacuna Inc.). And then there's malepregnancy.com.

Google Search: cloning

The fake cloning site is well done in a spooky kind of way. And if you type "cloning" into the Google search window, you get a sponsored link to the Godsend Institute website at the top of the page. Considering what's on the web these days, it's hard to get all lathered up over this hoax, but it still bothers me in a vague, undefined way. . . .

Godsend Institute.

If you want to see a movie promotion site that is over the top, but fascinating, check out the site for the new DeNiro move, Godsend.

Infectious disease . . . and the duty to treat: what are the limits?

I recently did a piece for the Pediatric Infectious Disease Journal on the duty (and the limits to that duty) of health care professionals to respond to an infectious disease even at a considerable risk to the responder. Today's N.Y. Times Magazine has an article that does a nice job of the epidemiology and the ethics issues related to it.