Growth in ER use fueled by insured patients, not uninsured.

The nonprofit, nonpartisan Center for Health System Change reports that most of the increase in ER use in recent years has been the result of increased E use by insured patients:

U.S. hospital emergency department (ED) visits increased to almost 108 million annually in 2000 and 2001, an increase of about 16 percent from 1996-97. Emergency department visits between 1996-97 and 2000-01 increased 24 percent for privately insured people, 10 percent for Medicare beneficiaries, 10 percent for self-pay or no-charge—typically uninsured—patients but were unchanged for Medicaid beneficiaries, according to the study based on data from the Centers for Disease Control and Prevention's (CDC) National Hospital Ambulatory Medical Care Survey.

Together, privately insured and Medicare beneficiaries accounted for almost two-thirds of the overall increase in ED visits. In contrast, self-pay or no-charge patients accounted for about 11 percent of the increase in ED visits. People with other sources of coverage—worker's compensation, for example—or unknown coverage accounted for the remaining increase.

For privately insured people, the 24 percent increase in ED visits paralleled an across-the-board increase in ambulatory care use, including a 29 percent increase in physician office visits between 1996-97 and 2000-01, the study found. In contrast, for uninsured people, the 10 percent increase in ED visits was accompanied by a 37 percent decrease in physician office visits, resulting in uninsured people relying on emergency departments for an even greater part of their medical care. One-fourth of all doctor visits by the uninsured now take place in emergency departments, compared with 17 percent in 1996-97.

"Uninsured people clearly are not a major factor in increased crowding at most hospital emergency departments, but uninsured people's growing reliance on emergency care indicates decreased access to other sources of care, including physician's offices. Getting medical care outside of the emergency department is definitely becoming more difficult for uninsured people," said HSC Senior Health Researcher Peter Cunningham, Ph.D., who co-authored the study with HSC Research Assistant Jessica May.

A news release and a link to the full report are here.

GAO report on specialty hospitals.

The article in this morning's NY Times on the rise of specialty hospitals (see below) mentions a report from the Government Accounting Office on the phenomenon. As today's "Health Law Highlights" from American Health Lawyers Association points out, the report "notes that specialty hospitals are largely for-profit and, in many cases, are owned in part by physicians. Specialty hospitals as a group tended to be less likely to have emergency departments, with 72% of cardiac hospitals, 50% of women's hospitals, 39% of surgical hospitals, and 33% of orthopedic hospitals having emergency departments. In contrast, 92% of general hospitals have emergency departments."

From this morning's NY Times: More on Schiavo, PVS, Medicare.

The NY Times is filled with stuff today:

• Schiavo I: article in "The Week in Review" about brain-damage and family decision making by Dudley Clendinen;
• Schiavo II: good piece by Sheila Dewan on the practical aspects of ethics consultations in cases like the Schiavo imbroglio (warning: this link will only last a few days);
• Schiavo III: an informative article about the American Academy of Neurology's guidelines for diagnosing permanent vegetative state (you can read them for yourself here);
• a front-page piece about the dramatic rise of specialty hospitals and the Medicare reimbursement scheme that has contributed to it.

FDA eases stance on importing medicines

The FDA has softened the official (hard) line against importing drugs from Canada, according to an article in today's Boston Globe: "'We're not considering legal action against cities or states,' said William K. Hubbard, associate commissioner for policy and planning at the FDA." The FDA isn't giving up its suits against the major suppliers to these state and local programs, however:

Hubbard said the FDA would continue its court battles against "businesses that sell commercial quantities of drugs" from overseas. The agency sent a cease-and-desist letter last month to CanaRx, the company that arranges for Canadian drugs to be shipped to Springfield. The Justice Department is awaiting a ruling after suing in Oklahoma to shut down a chain of stores that provide Canadian drugs under the names Rx Depot and Rx of Canada.

Presumably the cities and states are free to negotiate with Canadian pharmacies for discounted prices and employees would then be able to place their orders directly from the Canadian firms.

Slate opinion piece on the Schiavo case

There was a very good column by Dahlia Lithwick over at Slate. It builds on Alta Charo's point that this is case is mostly about who should decide and when should the state overrule that person's choices (and why).

Schiavo case reviewed by Florida's medical ethics community.

There's a good article in the Gainesville Sun today that contains the analysis of medical ethicists and legal experts in Florida. The commentary seems focused primarily upon Terry Schiavo's desire to avoid unwanted invasive treatments, but Alta Charo, quoted in an article in the Post-Crescent (Appleton-Neenah-Menasha, Wisc.) makes the more generally useful point that Schiavo is about the ability of a surrogate decision maker to make his or her decision stick in the event of a family dispute. "Once an individual has lost the ability to speak for herself, somebody must speak for her,” and once that happens, legal questions abound: who can speak for her? does the answer to that question change when the family disagrees about the outcome? what are the evidentiary standards and substantive rules that constrain the surrogate's choice? Of course, all those issues have been litigated for the better (or worse) part of 7 years: Terry's husband has been found to be the lawful surrogate and the choice he's made has been found to be consistent with the law of Florida for such choices, which makes the intervention by the legislature and the governor appallingly bad and shockingly opportunistic.

Schiavo redux.

The Times' web article on constitutional issues raised by the Florida legislation (mentioned here late yesterday) appeared in print today. Privacy, of course, is the big issue -- does Terri Schiavo have a right to have her medical decisions made by her husband or can the state override her surrogate's choice (based upon substituted judgment)? Beyond that, does a statute that is addressed to only one person's situation impermissibly blur the line between "legislature" (which typically decides policy issues prospectively and generically) and "court" (which typically decides issues retroactively and in the context of individual cases)? Problem is, those distinctions are frequently blurred by both courts and legislatures. The practice of passing "special legislation" for the benefit of one individual is so well established in the federal system that Congress has a separate calendar just for those measures. Florida's law on special legislation is reportedly quite narrow, and there may be some real question whether the Schiavo law would pass muster in that state.

The New York Times editorialized against the legislature's and governor's overruling of the many court decisions that have quite unremarkably upheld Terry Schiavo's husband's right to make the decision he's made.

Schiavo: reactions the day after.

Some reactions to the Florida legislature's and governor's intervention in the Schiavo case yesterday:

Democratic presidential hopeful Joe Lieberman backed the legislature and governor: "I believe that certainly in cases where there is not a living will ... I feel very strongly that we ought to honor life and we ought not to create a system where people are being deprived of nutrition or hydration in a way that ends their lives."

Harvard Law professor Larry Tribe is critical of the intervention, saying that it "violates the core principles" of the Supreme Court's 1990 decision in the Cruzan case. The New York Times ran a piece on their web page today - presumably intended for print on Thursday - laying out some of the constitutional arguments.

Senate Passes Ban on Abortion Procedure.

The Senate passed the partial-birth abortion bill today, according to a Washington Post report. Here's the text of the bill, S. 3 (when will newspapers start running bill numbers in their stories?)

Schiavo update #3

The Florida Senate jumped on the bill like a june bug on a water lily, Governor Bush signed the law, and pursuant to the law, he ordered Terri Schiavo's feeding tube reinserted. See The Washington Post's summary of the day's events.

There's nothing on the Governor's web site about this yet, but news announcements are posted here, so stay tuned. The bills are S12-E and H35-E. (The "E" is a reference to the fact that the legislature went into its fifth special session of the year on the 20th of this month.) Here are the key documents:

text of H35-E as engrossed and enrolled (PDF) (text);
text of S12-E (PDF) (text);
FindLaw's posting of the House bill as amended by the Senate; and
Senate staff analysis (PDF only).

Schiavo update #2.

A senate committee voted 10-2 this morning to send the House bill to the Senate floor for a vote, tentatively scheduled to occur this evening (according to the AP).

The same story reports that the federal judge who was assigned the case brought by the Advocacy Center for Persons with Disabilities has dismissed the case, writing that "federal courts - other than the U.S. Supreme Court - are forbidden from interjecting themselves into matters already decided by state courts."

The Schiavo case: legal process run amok.

As reported in numerous news outlets this morning, including the Sacramento Bee, the Florida House passed a bill yesterday that would authorize Gov. Jeb Bush to intervene and order a feeding tube for Terri Schiavo, a woman who has been diagnosed as being in a permanent vegetative state for the past 10 years. (You can find a House press release on the bill here. Unfortunately, it doesn't give the bill number, and I've so far been unable to find the bill through a text search of the House web site.) The bill is now before the Senate.

I've laid out the procedural and clinical details of this case in an earlier post. This latest move by parents, at least one sibling, and various right-to-life and disability-rights groups is either "desperately needed . . . to protect the people of this state" (Rep. Sandy Murman) or a bill that "so oversteps our role . . . it turns democracy on its head" (Rep. Dan Gelber). At the risk of repeating myself, this is apparently all about politics as a contact sport, with Terri Schiavo as the football. According to the AP, the attorney for her husband/guardian "said he thinks the legislation would be unconstitutional. He said it is Terri Schiavo's right under the Florida Constitution to not be kept alive artificially."

A letter to the editor in today's Sarasota Herald Tribune entitled "Some Things Are Worse Than Death" provides some perspective on the struggle of Terri's parents. Still, it's hard to believe that after 10 years and countless expert opinions, the parents insist that a little more rehab will restore their daughter to even a minimum quality of life. With his permission, here is an e-mailed summary of Terri Schiavo's condition from Ron Cranford, a neurologist who has personally examined her:

Terri Schiavo is in a classic permanent vegetative state. I have personally examined her and testified at a 6 day evidentiary hearing in Tampa in October, 2002, where six doctors testified on her neurologic condition, chances of recovery, and any possibility of her responding to treatment. The trial court judge concluded Terri was in a persistent (permanent) vegetative state, there was no possibility of recovery, and no chance of her responding to any treatment, including vasodilator therapy and hyperbaric oxygenation. Terri's most recent CT scans (extensively reviewed during the evidentiary hearing) show massive atrophy of the cerebral hemispheres, and the cerebellar hemispheres and brain stem, findings typical for a patient with severe and irreversible brain damage secondary to hypoxic-ischemic encephalopathy after 13 years in this condition. The trial court judge reviewed the videotaped examinations of the doctors testifying and completely rejected the opinion of the Florida neurologist representing the Schindler family that Terri showed signs of cognitive functioning. The one physician who was most likely persuasive in convincing Judge George Greer of Terri's neurologic condition was the neurologist from Cleveland, Ohio, who was the court appointed medical expert and thus not representing either the Schindler family and Michael Schiavo, the husband. Interestingly, not only did the 3 judge court of appeals agree with the trial court judge, but also reviewed the videotaped examinations of the doctors and agreed that Terri showed no signs of cognition.

If you look closely at the short videotapes released by the Schindler family, and know exactly what you're looking for, you'll see that Terri does not have sustained visual pursuit, the classic finding for someone outside a vegetative state. In the close up views of the mother interacting with Terri, you'll notice that it "appears" at times for a few seconds that Terri is "looking" at her mother, but, if you look closely, her eyes are not really tracking her mother most of the time. And she definitely would be tracking her mother the vast majority of the time were she not in a vegetative state.

According to an attorney who appears to be close to this case, a Florida-based nonprofit organization -- The Advocacy Center for Persons With Disabilities -- has filed an action in federal court to block the state court's dehydration order. He says their action is based upon "29 U.S.C. § 794(E) [sic]" (I assume he means 29 U.S.C. § 794e, which is a funding mechanism à la Baby Doe (42 U.S.C. §§ 5106g, 5106i(b)) but without the substantive treatment standards) and 42 U.S.C. § 15043(a)(2)(b) (which confers no legally enforceable rights as far as I can tell). As of 10am (CDT) this morning, there was nothing on their web site about the action.

To quote Letterman: "Is this something, or is this nothing?"

On Wednesday, Bayer Biological Products announced "the creation of an independent bioethics advisory body, the Bayer International Bioethics Advisory Council (BIBAC). The newly developed council, the first privately-funded international council of its kind, is dedicated to exploring and developing recommendations on ethical issues associated with biological products, such as those produced from blood plasma." Here's the background:

BIBAC is an expanded, international version of the highly successful former Canadian bioethics council, called the Bayer Advisory Council on Bioethics (BACB). Established in 1997 in response to Canadian public concerns about the safety and availability of blood and plasma, the BACB quickly established itself as a credible authority providing valuable counsel in dealing with the complex blood-related issues of the time. In fact, its inaugural paper, "Creutzfeldt-Jakob Disease, Blood and Blood Products: A Bioethical Framework" contributed to significant policy decisions in both Canada and the United States.

BIBAC's first paper can be viewed on the BIBAC Web site at www.BIBAC.org.

Another interesting grant of certiorari.

Congress is fond of using its powers under the Taxing and Spending Clause to enact legislation that might be at least questionable if it was passed as a straight-up regulation. Think, for example of EMTALA (imposing duty to screen and treat on hospitals as a condition of their receipt of federal health care funds) or Baby Doe (imposing enforcement obligations on states to ensure that infants receive "medically indicated treatment" as a condition of the receipt of federal funds for CPS programs). As a general proposition, Congress enjoys roughly the same freedom to legislate to promote the general welfare of the public as is enjoyed by state and local officials who exercise comparably broad broad "police powers" when they legislate.

Yesterday, SCOTUS granted certiorari in Sabri v. United States, No. 03-44. In the case, a developer was charged with bribing a city council member in Minneapolis. The federal statute under which he was charged makes it a crime to pay a bribe of at least $5,000 to an official whose agency receives at least $10,000 in federal money. There's no requirement that the bribe be related to the federal program for which federal funds are received by the official's agency. Linda Greenhouse's description of the case in today's N.Y. Times includes the suggestion that this case could signal the Court's interest in cutting back on Congress' powers under the Spending Clause, just as it has been doing in connection with the Commerce Clause over the past 5 years. In his blawg, Prof. Eric Muller (passed along to members of the Con Law Prof listserv by Eugene Volokh) wonders why an exercise of Congress' Spending Clause powers should be suspect when a ban on bribes over $5,000 could have been enacted pursuant to Congress' power to regulate interstate commerce. Fair question. (The district court dismissed the charges but the 8th Cir. reinstated them as a constitutional exercise of Congress' powers under the "necessary and proper" clause. The 8th Cir. case -- U.S. v. Basim Omar Sabri -- is available for free here.)

Terri Schiavo's final days.

The New York Times ran an article by Abby Goodnough on the final legal and medical moves in the case of Terri Schiavo, diagnosed as being in a permanent vegetative state after an anoxic event in 1990. I've previously discussed this case here.

SCOTUS declines review of medical-marijuana gag-rule case.

The Supreme Court denied cert. in a 9th Circuit case (Walters v. Conant, No. 03-40) that ruled doctors couldn't be prohibited by the federal government from discussing the risks and benefits of medical marijuana with patients in states that have legalized medical marijuana, although if they help the patients obtain pot they can be prosecuted as accessories or for conspiracy, at a minimum. The freedom-loving Bush Administration sought review. The 9th Circuit case is Conant v. Walters, 309 F.3d 629 (9th Cir. 2002); you can read it here (requires subscription to Westlaw) or here (free on Findlaw).

Genetic discrimination bill passes Senate, 95-0.

Modern Healthcare's "Daily Dose" reports that S. 1053 passed in the Senate today by a 95-0 vote. (If you're looking for confirmation (and remarks from the floor), today's Congressional Record will publish the proceedings tomorrow.) The bill, sponsored by Sen. Olympia Snowe (R.-Me.) and 10 co-sponsors, would prohibit employers and insurers from making employment and coverage decisions on the basis of genetic information. The provisions seem largely to duplicate similar provisions already enacted by many states, including Texas (Insurance Code; Labor Code). Ted Kennedy praised the measure; the president of the Health Insurance Association of America criticized it as unnecessary in light of the antidiscrimination provisions in HIPAA.

Pregnancy Created Using Infertile Woman's Egg Nucleus.

It's not all that common for a news story to give me an exam question in three of my courses, but this one comes pretty close.

Denise Grady has a piece in today's N.Y. Times that picks up on an AP story that ran on Monday concerning a Chinese procedure for extracting the nucleus of a fertilized egg, inserting the genetic material into a denucleated egg of another woman, and implanting the "new" egg into the uterus of the first woman. The process initiated a pregnancy in a woman who previously could not maintain a pregnancy with a blastocyst beyond the two-cell stage. The new technique resulted in three fetuses, one of which was aborted to give the other two a better chance of survival, and the remaining fetuses died at 24 and 29 weeks. Because this technique involves nuclear transfer, the process has set off alarms among those who are uncomfortable that this is one more step toward human reproductive cloning. It's not exactly cloning, which involves making a genetic copy of oneself, but Jeffrey Kahn of the University of Minnesota worries that it amounts to "'proof of principle' for cloning even if no copying took place."

The technique also adds to biotech's contributions to Family Law exam questions. Consider this headline, from today's Belfast (Ire.) News: "Scientists Create Test Tube Twins with Two 'Mothers'."

It also raises a nice question for a Bioethics exam. As today's Newsday article on the story put it:

But none of her three developing fetuses survived, and some question the ethics of such research.

"The gestational outcome was a disaster," said Dr. James Grifo, director of the division of reproductive endocrinology at New York University. Grifo and his NYU colleague, Dr. John Zhang, are listed on the abstract of a paper on the case to be delivered today at the American Society for Reproductive Medicine meeting in Texas. Grifo said they didn't have anything to do with the clinical research "beyond showing them how to do it."

Malcolm Ritter's AP story (from the Ft. Worth Star-Telegram) on the ASRM conference in San Antonio quotes others who aren't so sure about the "roadmap to cloning" argument:

R. Alta Charo, professor of bioethics at the University of Wisconsin at Madison, said the Chinese work is not a direct analogy to cloning. A key difference is that the transferred DNA does not have to be reprogrammed to act properly in an egg as it does in cloning, she said. So the study result doesn't offer a direct indication of the outcome of attempts to clone humans, she said.

[Dr. Joe Massey, a fertility specialist at Reproductive Biology Associates in Atlanta] and [Dr. David Sable, director of the division of reproductive endocrinology at the St. Barnabas Medical Center in Livingston, N.J.,] said the experiment was not cloning, with Massey stressing that it wasn't aimed at copying an individual. "This is not a pathway to cloning. It's not about that," Massey said.

Finally, for the Administrative Law exam, consider this: Dr. Grifo, the NYU researcher who advised the Chinese team, "said the Food and Drug Administration indicated that work he was doing might be subject to government regulation, and he stopped his experiments in 1998 because of the energy and money required to comply." I wonder what the FDA is thinking this morning about his participation in the Chinese experiment.

Stopping a clinical trial before it's complete.

The New York Times editorialized today about a recent decision to end a clinical trial of a breast-cancer treatment because the results were looking so good, the researchers wanted to get the apparently beneficial treatment out to a larger number of women than just those who were enrolled in the research:

The study was testing the value of administering the drug letrozole to older women who had already taken tamoxifen to ward off a recurrence for about five years, the point at which tamoxifen loses its power. The results exceeded expectations. When compared with a placebo, letrozole cut the recurrence rate nearly in half.

As the Times correctly points out, "[t]here seems little doubt that a trial must be terminated if it is harming the participants"; indeed, that is precisely what data safety monitoring boards do. But, as the editorial observes:

By halting the study in midstream, the researchers made the new treatment available to the placebo group and to many thousands of other cancer survivors as well. The downside is that early termination kept them from determining whether the treatment actually saved lives, how long women should keep taking the drug or the likelihood of such adverse effects as osteoporosis and cardiovascular problems.

The National Breast Cancer Coalition has criticized the National Cancer Institute's decision to halt the clinical trial, and their paper makes a lot of sense. The National Cancer Institute's explanation for its decision, with a link to a Q&A page on the letrozole study, is here. The researchers' article, which is scheduled to appear in the New England Journal of Medicine on November 6, was posted to the journal's website on October 9 "[b]ecause of its potential therapeutic implications." [Abstract available here without subscription]

Separation of Egyptian conjoined twins begins in Dallas today.

Excellent article in this morning's Dallas Morning News by Laura Beil about the ethics of performing surgery to separate two Eqyptian brothers who are joined at the tops of their heads. As co-chair of the ethics committee at Children's Medical Center Dallas, where the separation is being performed, I have given lengthy interviews to a lot of reporters about the ethics of separation and the process that we went through at Children's, and Laura's piece is the only one I've seen (so far) that has attempted to lay out the ethical analysis. The article also quotes Prof. Adrienne Asch of Wellesley College, who makes a valid point about society's culturally determined notions of what is "normal":

The surgeons know there are those who will take exception with the decision to operate. One expert who disagrees is Adrienne Asch, a professor of reproduction and bioethics issues at Wellesley College in Massachusetts.

Dr. Asch is disturbed by the drive to separate conjoined twins because it is usually based on the sense that being conjoined is not a "normal" way to live. But what does normal mean? Does it mean average, or outside statistical boundaries, or desirable? Star athletes and Nobel Prize winners have outstanding qualities that are not considered normal, she pointed out. "We think of some non-normal things as desirable," she said.

People live good lives in a variety of circumstances, and it is not for others to decide whether their circumstances are a burden. To ask whether two conjoined brothers should be separate, she said, is almost akin to asking a black person whether they should be white, or a woman whether she would be better off as a man.

"I don't even like the word normal," she said.

If society considered it acceptable to be conjoined, being attached to your brother or sister would be an unusual but perfectly legitimate way to live, she said. The biggest disability facing these twins, is that society considers it strange. "That's the principal impairment of being conjoined," she said.

I am not so sure that stigmatization is the biggest impairment facing a child with a sibling who is his size and weight attached to the top of his head, or that with these brothers we are dealing with a physical condition that would be considered "normal" in other societies but not here. But I do agree that "normal" is a loaded term that is not particularly helpful in resolving the question whether to separate or leave together conjoined twins.