Pediatric drug testing.

According to an article in the Philadelphia Inquirer, the Senate voted yesterday to approve a bill (S. 650) that would require drugmakers to include children in the study of drugs intended to be used in minors. Last year a district court invalidated an FDA rule that would have done the same thing on the ground that it was not authorized by statute. The Senate's action yesterday is one step toward providing solid statutory support for such a requirement, which is long overdue.

Letterman.

If you caught David Letterman last night, you know he featured the 7/22 N.Y. Times headline, "Astronomers Report Evidence of 'Dark Energy' Splitting the Universe". I'm positive that Dave -- a regular reader of HealthLawBlog -- picked up this item from Tuesday's blawg.

Medical error reporting legislation.

According to an article in today's "Daily Dose" from Modern Healthcare, the Senate Health, Education, Labor and Pensions Committee approved "[a] bill that would set up a voluntary, nonpunitive system for medical-errors reporting . . . 20-0 . . . today. . . . Under the Senate bill, HHS would oversee the creation of a national database to aggregate information on medical errors." See S. 720 for more details, including a complete legislative history.

Physicians and antitrust.

The FTC settled yet another physician case -- the 10th in 20 months according to and article in Modern Healthcare's "Daily Dose." The FTC has all the details about the case against a Baton Rouge IPA and their consultant on its web page. As has been noted in this space before, as tempting as it is to deal with managed care organizations through a little old-fashioned price-fixing, and despite the Supreme Court's recent cases weakening the foundations of the per se doctrine, this is still the classic antitrust offense.

Insuring against punitive damages.

As reported in the July 22 Texas Lawyer, a panel of the 2nd Court of Appeals in Fort Worth has voted 2-1 that insuring for punitives does not violate public policy. The case is Westchester Fire Insurance Co. v. Admiral Insurance Co. This could be a really big deal, if the Texas Supreme Court takes the case, no matter which way they go on this issue.

German health care reform.

Today's Wall Street Journal (requires subscription) reports that Germany's health system is about to be reworked, if a government plan passes the legislature: "The overall costs of the health system wouldn't be much reduced. Instead, for the first time, patients would be charged small fees for treatments, hospital stays and medicine. Sick pay and certain dental expenses would no longer be covered by the public system. . . . The annual burden on the system would be cut by about €10 billion ($11.3 billion) starting next year and by as much as €23 billion annually by 2007, the government said. Health care payments would fall to 13% as a percentage of gross wages by 2006, from 14.4% today, according to the plan. Health care is the biggest social expenditure after pensions. . . . The measures would also go some way toward opening up the health care industry to private insurers and to more competition. . . . But the package stops short of allowing health insurance providers to choose the hospitals or doctors with which they have contracts. The current system has fixed contracts between hospitals and providers, an arrangement some analysts say stifles competition and hurts quality." Interesting that -- coming from very different starting points -- both the German government and the U.S. House and Senate are looking to privatization and increased competition to meet the soaring demands of ever-more-costly health insurance plans.

If you're feeling a little low, this won't help.

You have to love the copy desk chief who writes the headlines in the "Science" section of the N.Y. Times. My favorite headline, until this morning, was "Mass Found in Elusive Particle; Universe May Never Be the Same" (June 5, 1998). Over my morning cup of coffee today, however, I stumbled across this gem: Astronomers Report Evidence of 'Dark Energy' Splitting the Universe. Kind of makes me think Buffy was on to something.

Universal coverage.

Jacob Hacker has an interesting piece in the July 20 Boston Globe. It starts:

STILL SMARTING FROM defeat, a leading activist ruefully explained why once-promising plans to expand health coverage had failed. Health legislation, he said, affected ''powerful group interests'' and was easy fodder for scare-tactic attacks. ''All these fears, some justified, some exaggerated, and some altogether fanciful,'' he said, ''produced such a confusion of group conflicts that only a clear recognition of the need... might have overcome it, and that clear recognition was lacking.''

All this would be an incisive assessment of the demise of the Clinton health plan in 1994-if, that is, it hadn't been offered in 1930, and if its author, the social reformer Isaac Max Rubinow, hadn't in fact been talking about the failure of the first campaign for expanded insurance in the late 1910s.

He goes on to mount a spirited defense of "play or pay" - requiring employers to contribute to an insurance fund if they do not provide health benefits for their employers, which he argues is a Clinton-era idea whose time might have come.

Medicare Rx benefit.

Good article in today's New York Times about the competing House and Senate bills to reform Medicare. The Kaiser Foundation's Daily Health Policy report, as usual, lays out the issues nicely, adds a discussion of "dual eligibles," and picks up on some coverage and commentary from other newspapers around the country.

Hospital billing inquiry.

On July 16, House Energy and Commerce Committee Chairman Billy Tauzin (R-LA) and Oversight and Investigations Subcommittee Chairman James Greenwood (R-PA) sent letters to 20 hospitals and hospital systems. As reported in the July 17 Wall Street Journal (requires subscription), the investigation is into "hospital billing practices that often require uninsured patients to pay rates that far exceed what other payers, including the government and HMOs, are charged. . . . The committee also asked the hospitals to disclose their charity-care practices and how they go about identifying financially needy patients who may need help." Assuming the hospitals are all forthcoming about this massive request for data, it promises to be a fascinating proceeding. As the WSJ article puts it: "At the heart of the congressional investigation is the thorny issue of 'charges,' which are the retail prices that hospitals list for their services. According to the letter, these rates are 'often inflated far beyond [the hospitals'] actual costs and reasonable profit.' Some payers are able to negotiate discounts and pay far less, but 'individual uninsured patients are expected to pay this full, undiscounted "sticker" price,' the congressional letter said. Added [a committee spokesperson]: 'In some cases, it appears that the very people who can least afford it are paying the full sticker price for hospital services.'" I sure hope we see a report coming out of all this.

[Self-]analyze this.

Today's on-line health edition of The Wall Street Journal has an article in its "Science Journal" (requires subscription) about evolutionary psychology and mate selection. Evolutionary psychologists claim that the better looking a woman is, the more she expects from a mate in terms of status, wealth, and power. It works the other way around, too, hence the "trophy wife" title for this theory. (Anna Nicole and J. Howard Marshall are the poster kids for this one.) It turns out that Cornell researchers have an alternative explanation that explains the data even better: we look for mates who have traits that we see in ourselves (i.e., "likes attract"). The article concludes: "There's only one problem with the notion that we look for mates who resemble ourselves: We generally stink at self-evaluation. 'People tend to be blissfully unaware of their incompetence,' concludes a study by Cornell and University of Illinois at Urbana-Champaign scientists in the journal Psychological Science. 'Where they lack skill or knowledge, they greatly overestimate their expertise and talent, thinking they are doing just fine when, in fact, they are doing quite poorly.'" This may explain why deans like student evaluations as much as they do.

Human tissue barbarity.

A story in today's Austin American-Statesman reports that a San Marcos father specified that his teenaged son's heart, corneas, and bones -- which were harvested while the father was out of the country -- should be donated without profit. When the Red Cross and the eye bank determined that they couldn't guarantee that someone wouldn't make a profit off his son's parts, both firms shipped the parts back: "In a FedEx package came his son's corneas, packed in a preserving solution. In a cooler filled with dry ice Roberts found his son's femurs, kneecaps, hip bones and shoulder blades. His son's heart was in a jar." Nice touch. Granted, the dad was somewhat naive about the workings of the human-tissue industry, and his request undoubtedly put the organizations in a bit of a bind - one that their disclosure forms were drafted to avoid, by putting donor families on notice that some firm or person down the line might make a profit from the donated body parts. But was this the way to handle it? As the peripatetic Art Caplan is quoted as saying: "'Repugnant doesn't capture it,' he said. 'The decision to do that is as serious a breach with the public as you can find. If you want to stop people from donating organs, return them to a funeral home.'"

Poetry and medicine.

Last evening's "All Things Considered" had a wonderful piece about the author of Singular Intimacies: Becoming a Doctor at Bellevue, Dr. Danielle Ofri. [If you follow the link to NPR, be sure to click on the audio version of the story; the "transcript" provided on that page is woefully incomplete.] Among other things, hospital teaching rounds includes some time for poetry, in this case "Gaudeamus Igitur," a truly magnificent poem by John Stone, a cardiologist at Emory and a fine poet. This poem is one of the highlights every year in my Law, Literature & Medicine class, and I strongly recommend it to anyone reading this blog. It's here.

Valium turns 40.

"Mother's little helper" . . . "Executive excedrin" . . . one of the "dolls" popped by the characters in Jackie Susann's Valley of the Dolls . . . as pointed out in an article in today's Duluth News Tribune, this is the year iconic Valium (diazepam) turns 40. Although Valium is not intended for chronic use, by 1978 American's were downing 2.3 billion tablets a year. Highly useful, but highly abusable, it's the drug that makes me think my generation knows what it's talking about when it worries that our culture has become too dependent on mood altering drugs to get us (and our kids) through the day.

Children's hospitals' growth spurt.

Today's Boston Globe has a very interesting piece about the growth spurt in children's hospitals in Boston, LA, Buffalo, Indianapolis, Miami, New York, Phoenix, San Jose, Rochester (N.Y.), Chicago, and Denver. They might also have mentioned Dallas - have you driven by Children's Medical Center at Motor Street and Medical Center Drive recently?

Medicaid services for the dead.

Kaisernetwork.org's daily report mentions an article in the Memphis Commerical Appeal that Medicaid auditors have found 1,997 instance over the past five years in which the Medicaid program was charged $159,896 for services provided to patients who had died. Some or all of this might be computer error (at least faulty data entry) but any cases that are accurately reported obviously fall outside the standard of "medically necessary" care. Patients who are "brain dead" continue to receive services if they are organ donors, but those expenses are paid by the Organ Procurement Organization, not by health insurance programs (public or private). Brain dead patients will sometimes remain on life-support in the hospital for hours or sometimes days, until the family is more comfortable with the concept or more accepting of their loss, or until out-of-town family members can assemble at the bedside. I've always assumed that hospitals eat those charges rather than try to get reimbursed for them, and in any event, if this were the explanation, there'd be more money involved than $80 per patient (on average). So either Tennessee has a lot of data entry clerks who need to be retrained (or a lot of forms that need to be reformatted) or it's literally pay-back time for these hospitals.

Conjoined twins.

Last week's failed attempt to separate the 29-year-old sisters from Iran, Ladan and Laleh Bijani, has spawned a lively international bioethics debate that is described in a story by Denise Grady in today's New York Times. Dr. Mark Siegler's flip-flop on the issue is especially worth pondering. Is he right that a 50% chance of survival is too low for the surgeons ethically to perform the requested separation when the surgery wasn't necessary to treat a life-threatening condition? How relevant is the label "elective" as a description of the surgery, which was so deperately sought by the twins, whose competence cannot really be debated?

In vitro fertilization.

There is a useful summary of current IVF practices in an article in today's New York Times. This is a fast-moving field, and law and ethics are largely driven by technology (and commerce), which makes this sort of report especially useful.

Medicare reform. Why should we be surprised? The Washington Post reports today that the Medicare not-exactly-comprehensive-prescription-drug-benefit-that-we-still-can't-afford bills (S. 1, H.R. 1) have "become a magnet for dozens of unrelated provisions benefiting hospitals, doctors, medical equipment companies and an array of other health care interests." Citing "many [provisions] dropped into the legislation in the small hours of June 27, just before Senate passage [that] would benefit [chiropractors,] marriage counselors, the weight-management industry, rural ambulance services, Hawaii's Medicaid program and doctors in Alaska." Stating the obvious, but something that needs to be said anyway, the Post writes: "the legislation proved to be an irresistible target for an army of health care lobbyists lured by the first major Medicare bill to move through Congress in three years."

Abortion - minors. On Thursday, July 10, Florida's Supreme Court struck down that state's parental-notification law, which requires a minor who wants an abortion either (1) to notify their parents or (2) to obtain a judicial order that declares (i) that the minor is sufficiently mature to make her own reproductive decisions or (ii) if the minor is not sufficiently mature, that an abortion would nonetheless be in her best interests. The opinions are here. Florida's law sounds virtually the same as Texas' parental-notification law, whose constitutionality has been upheld by the Texas Supreme Court. The Florida decision was based upon a state constitutional provision (Art. I, § 23) that provides: "Every natural person has the right to be left alone and free from governmental intrusion into his [sic] private life . . . ."

Medicare reform. The Wall Street Journal has an electronic health-care edition that collects print stories about health care, medicine, health policy, etc. in one place, but (as with the basic newspaper web product), it costs money. If you subscribe, you can check out three articles on July 11 that discuss Medicare reform and its potential impact on the Rx drug industry, pharmacy benefit managers, and private health plans. (They are available on the WSJ's "Remaking Medicare" page, which is a good place to visit to prepare for next month's conference committee's attempt to reconcile the competing House and Senate attempts to reform Medicare.) If you don't subscribe, the Kaiser Family Foundation's "Daily Health Policy Report" has a summary of all three articles (for free) on its web page.

Linking med-mal reform and health care reform: Michael Kinsley does a nice job of linkage in his July 10 column, A Painful Malpractice Debate in the Washington Post:

Very few winners of what the critics call the lawsuit lottery actually win enough to make it a deal they would take voluntarily. . . . So the direct effect of restricting the size of malpractice judgments would be to increase injustice, not to reduce it. Nevertheless, limits on malpractice lawsuits are a good idea that Democrats are wrong, and possibly foolish, to oppose. The current arrangement delivers justice at random, in widely varying amounts or not at all, depending on whether you're feeling litigious, how good your lawyer is or what a judge or a juror had for breakfast that day. It is less a matter of injustice than of more justice than we can afford. . . . It is a society with an odd sense of justice that awards millions of dollars to every 25th victim of what may or may not have been a botched operation but doesn't guarantee basic health care to anyone. But it is a political party with an odd sense of justice that makes a big issue of the former and basically ignores the latter. Republicans are right about malpractice reform. They may not realize quite how right they are.

Media scan. Hard to miss the wild disparities that abound in health care these days.
Example: Maine, whose discount-Rx drug scheme was recently upheld by the Supreme Court, is currently on the road to statewide universal health coverage, according to an
article in today's Baltimore Sun.
Example: Robin Toner and Robert Pear report in today's NY Times that both parties in Congress are locked in a battle over whose less-than-comprehensive-Medicare-drug-benefit-we-can't-really-afford bill will be passed . . . hanging in the balance are bragging rights for the 2004 elections.
Example: Meanwhile Medicare continues to cut reimbursements to physicians who in turn are refusing to take on new Medicare patients (it doesn't really qualify as news, but it is reported in today's Springfield (Mo.) News Leader). If Congress can't afford the Medicare benefits it's provided for up till now, it kind of makes you wonder how even a modest prescription drug benefit will be paid for, doesn't it?
Example: Finally, for a truly terrifying look into one of our alternative futures, consider the Canadian Medicare program, long a model for those, like me, who think a universal-coverage, single-payer system would solve a lot of the problems of the US' so-called system. The Canadian system is being wracked by the political problem of how to control costs in a humane and civilized way. As reported in an article in today's Toronto Star, by 1999 "85 cents of every new dollar collected [by federal and provincial governments] went to health care." That is obviously not sustainable, and yet who in the US has a sensible alternative to this picture?

Quality. Yesterday DHHS and CMS announced a three-year demonstration project to provide financial incentives to participating hospitals that provide high quality care for Medicare patients. The project will track performance data for "heart attack, heart failure, pneumonia, coronary artery bypass graft and hip and knee replacements. Measures include prescription of aspirin for heart attack and bypass graft patients and timely administration of antibiotics for pneumonia patients." As described in the DHHS press release:

Hospitals will be scored on the quality measures related to each condition, and those hospitals in the top 10 percent for a given condition will be given a 2 percent bonus on their Medicare payments. Hospitals in the second 10 percent will be given a 1 percent bonus. Hospitals in the remainder of the top 50 percent will be given recognition for their quality but no bonus.

Premier Inc. will do the data tracking, and -- although this was unclear from the DHHS press release -- Premier's press release intimated that the demonstration will not be limited to the approximately 500 facilities that already track and report quality-of-care data through Premier's tracking system. Incentives will total $7 million per year for the 300 participating hospitals -- that's an average of $23,333 per hospital. As a percentage of any decent sized hospital's operating budget, that's a relatively paltry incentive. (By way of comparison, some hospitals are paying individual signing bonuses of $25,000 to get nurses in high-demand specialties.) Obviously, DHHS and CMS want to point to something they can say they are doing to improve health care quality, but in the current budget environment, the cash for something splashier apparently just isn't there . . . even for a program that CMS chief Tom Scully says will partly pay for itself by reducing hospital readmissions.

The most surprising part of this story came out in Robert Pear's article in today's New York Times. As any regular reader of The Times could have told Secretary Thompson or CMS chief Tom Scully, Premier has been under investigation for the past year by state and federal officials for possible antitrust violations. That's not enough to scuttle Premier as a partner in this project, but is it credible that no one at CMS -- including Scully, who "said he knew little about the investigations until a journalist made inquiries at his office today" -- had pulled up The Times' multi-part series on Premier and its competitors in the lucrative hospital-supply industry before inking this deal?

Good quote. Eugene Volokh (whose book on Academic Legal Writing is without peer), posted this quote from Oliver Wendell Holmes on his blawg and I thought it was a quite fitting way to end our summer session together in Bioethics (as it would be for just about any course in law school!).

Med-mal reform. Modern Healthcare's Daily Dose reports that the Senate voted 49-48 to table the med mal reform bill, which is undoubtedly the death knell for that troubled piece of legislation. Wild-eyed liberal that I am, I won't be crying tears over the (temporary) end of this Congressional frolic and detour. This really is more suited for the states, isn't it?

Obits. The July 8 Canadian Medical Association Journal has an interesting piece about the firestorm that erupted after the British Medical Journal published a critical obit of a recently deceased doc. Apart from the question whether the dead doc actually will turn out to be the greatest snakeoil salesman of his time, there is the somewhat interesting question whether obits should merely celebrate the highlights and impassively report on the lowlights of a life, or should they jump into the fray with full-throated opinions. I vote for the latter . . . . it's a lot more interesting than the bland stuff that most papers and especially professional journals pass off as obituaries.

Antitrust. Modern Healthcare's Daily Dose reports that another physician group (this time a PHO in Maine) has agreed (without admitting wrong-doing) to stop price-fixing activities. The Maine attorney general issued a press release stating that his office had alleged the PHO violated a state law that allows "[a]greements among competitors on price and other competitively significant contract terms . . . where the joint activities of the providers have a real potential to increase quality of care and reduce cost, and where the joint contracting appears reasonably necessary for the achievement of those benefits to patients and consumers." So far, this year has seen a steady stream of price-fixing cases, some from the FTC, involving health care providers (mostly physicians). Sooner or later, they will get the message . . . .

Family Code and the 78th Tex. Leg. You can't beat the Family Law Section of the State Bar of Texas for its timely and authoritative listing of new family-law-related statutes from the 78th Legislature. Good job!!

And thanks, too, to Tim Mighell for his mention over at his excellent Inter Alia site!

Thanks to Ernie the Attorney for his mention of this new blawg! Now, if I can just figure out what the brouhaha about "RSS feed" is all about . . .

"Brain dead." From time to time I give a talk to health professionals entitled, "Medically dead, legally dead, brain dead, or really dead?," intended to highlight (and dispel) popular confusion about the concept of brain death (more accurately: "death according to neurological criteria"). A source of confusion are news media that almost invariably get it wrong. Ironically, I made this point in my Bioethics class just this past Thursday, and The Dallas Morning News promptly obliged with an article in the Metro section of today's paper. Reporting on a tragic drive-by shooting during a 4th of July cookout, the author stated: "Juan Medina, 20, a father of one of the wounded children, was declared brain-dead but was being kept alive by life support Saturday evening." "Brain dead" is not "sort of dead" or "partly dead": it's dead dead! Poor Mr. Medina may be on a ventilator, but he's not alive. My prediction: in tomorrow's paper, the Morning News will dutifully report that the brain-dead Mr. Medina was taken off life-support and "allowed to die." You heard it here first.

Good samaritan law. Last year the Austin Court of Appeals stumbled badly in the MacIntyre case by almost reading the Good Samaritan Act out of the law. Admittedly, the provision they construed was not a model of clarity. Texas' Civil Practice and Remedies Code § 74.001 states that the law's immunity doesn't apply if the "good samaritan" was acting "for or in expectation of remuneration," and it goes on to say that a person acts "in expectation of remuneration" if that person "would ordinarily . . . be entitled to receive . . . remuneration for administering care under such circumstances . . . even if the person waives or elects not to charge or receive remuneration on the occasion in question." Actually, not a bad idea, but under what conceivable set of circumstances would a responding physician not be entitled to remuneration under some legal theory any time he or she responds to an emergency? Taken at face value, this provision all but writes physicians out of the law, which can't be what the Leg intended to do. The Austin court read the plain language of the statute, however, and said there was at least a triable factual question as to whether the responding physician was entitled to receive remuneration for delivering the plaintiff's baby, even though the defendant's deposition testimony was that he didn't bill for his services, he had never billed for such services, he regarded billing for such services to be unethical, and he knows of no physician who does bill for such services. On June 26, the Texas Supreme Court reversed the Austin court in a unanimous opinion, McIntyre v. Ramirez. It took some fancy footwork to get around the admittedly plain language of the statute, but they got it right. Meanwhile, the 78th Texas Legislature recently amended the Good Samaritan Act. Section 10.01 of H.B. 4, the med mal reform law, completely rewrote chapter 74, retitled it "Medical Liability," and stuck the Good Samaritan Act (renamed "Emergency Care") in subchapter D (§§ 74.151-.154), making it clear that "being legally entitled to receive remuneration for the emergency care rendered shall not determine whether or not the care was administered for or in anticipation of remuneration." This was a lot of effort to fix a law that should have been better in the first place, eh?