South Korean cloning breakthrough and the Times.

It's pretty obvious the New York Times doesn't want to see any angle on the most recent human-cloning story appear first in a rival paper. In the last couple of days there has been a raft of stories occasioned by the story of South Korean scientists who have cloned a human embryo:

• Denise Grady filed first with a story on early reactions to the Korean story: "Debate Over Cloning in U.S. Remains Intense" (Feb. 12);



• Samuel Len's story profiled the Korean researchers who broke through: "South Korea, With Renowned Scientists, Revives Debate" (Feb. 13);



• Laurie Goodstein and Denise Grady did a story on the debate in this country over cloning-for-reproduction vs. cloning-for-therapy: "Split on Clones: Research vs. Reproduction" (Feb. 13);



• Andrew Pollack has a good story on what remains to be learned before cloning for stem cells will produce therapeutically useful interventions: "Medical and Ethical Issues Cloud Plans to Clone for Therapy" (Feb. 13);



• Gina Kolata does her usual excellent job in today's N.Y. Times on the cloning story: "Despite Advance in Cloning, Scientists Are Tempering Hope With Reality" (Feb. 15);



• Nicholas Wade did a story about the double default cause by the Bush administration's current policy against cloning for therapeutic research (the possibility of a science gap as researchers in other countries leap-frog over hog-tied researchers in this country, combined with our inability -- as a non-player -- to participate in the ethics and policy discussion): "Human Cloning Marches On, Without U.S. Help" (Feb. 15); and



• from Dale Fuchs a story about a stem-cell bank in Spain: "Bank for Human Stem Cells Starts Ethics Debate in Spain" (Feb. 15).

Interns' diary.

Two interns at a Harvard-affiliated teaching hospital are publishing a 5-day journal this week in Slate: http://slate.msn.com/id/2094977/entry/2095201/. Ingrid Katz (Amherst '93) and her partner, Alexi Wright, are the authors. They are also occasional bloggers (a link to their blog is over there in the left-hand column of this page).

Scalia says "nuts" to recusal for ducks.

Speaking at my alma mater last night, Antonin Scalia provided his most direct answer to date concerning calls for him to recuse himself from a hotly contested APA case involving Dick Cheney, with whom he went duck hunting last month. According to an article in the Boston Globe, Scalia said he saw no conflict of interest. As reported in Slate.com, he added that Cheney hasn't been sued in his personal capacity, only in his official capacity as Veep, and neither the law nor Court tradition prohibits socializing with executive branch officials who are not parties before the Court in their personal capacity.

Stark II, Part 2, regs postponed . . . . again.

The OMB's OIRA Executive Order Submissions Under Review document has been recently revised to show a new "Received" date of 12/7/2003 for the Stark II rule (Part 2):

HHS-CMS RIN: 0938-AK67
Medicare Program; Physicians' Referrals to Health Care Entities
with which they have Financial Relationships -- Phase II
STAGE: Final Rule ECONOMICALLY SIGNIFICANT: No
RECEIVED: 12/17/2003 LEGAL DEADLINE: None

That means the rule probably won't be out before March 16. Care to make a little wager that it won't be published before summer?

NY Times: Whose Problem Is Health Care?

Nice piece in today's business section of the New York Times by Daniel Gross on the problems of employer-based health care. The story is about a December 2003 report from the Manufacturers Alliance and the National Association of Manufacturers that details the factors that make it difficult for American manufacturers to compete with foreign firms -- not just those in developing countries with low labor costs, but in developed countries as well. One of the culprits that cancels out gains in productivity and cost controls is the structural costs of operating in the US: corporate income taxes, employee benefits, and rule compliance. The article looks particularly at health care costs:

After corporate income taxes, employee benefits are the second-largest structural cost for American manufacturers, adding 5.8 percent to costs, according to the study. In all major economies, paying for health care means a combination of public and private money. But in the United States, businesses pay a larger chunk than do their European and Asian counterparts.

"In Canada, for example, a lot of the expenditures for health are funded out of general revenues," said Jeremy Leonard, an economic consultant for the Manufacturers Alliance, and the report's main author.

In Canada, the private sector spends 2.8 percent of gross domestic product on health care; in the United States, the private-sector figure is 7.7 percent. And American private-sector spending falls disproportionately on big employers like manufacturers. Some 97 percent of members of the National Association of Manufacturers provide health care coverage for employees. In 2002 alone, General Motors, which covers 1.2 million Americans, spent $4.5 billion on health care.

Best quote, predictably, comes from the eminently quotable Uwe Reinhardt, "an economist at Princeton, has referred to General Motors, Ford and Daimler-Chrysler as 'a social insurance system that sells cars to finance itself.'''

The debate is between a governmental program for retiree health care (and can employee health care then be far behind?) and the current, privately financed employer-based approach. The article concludes, "Whatever way, we all pay." Increasingly, though, large employers are looking for ways to shift their health-care costs to a larger denominator (say, all taxpayers). The tradeoff in terms of slight increases in corporate taxes will be more that offset by the many-times-larger reduction in health-care costs. It will be interesting to see if and when the captains of industry start throwing themselves behind a national, single-payer system. . . .

How Appealing's 20 questions site.

I am continually impressed by Howard Bashman's How Appealing's 20 questions site. Students looking for a diverse collection of opinions by sitting appellate judges on the nature of their work -- and, necessarily, their view of the Constitution, Congress, their relationship with the Supreme Court, etc. -- will have a field day on this site. There doesn't appear to be any ideological bias here - the judges represent all points along the two-party political spectrum (apparently no Greens need apply for judicial appointments in this country), and the questions are probing but respectful. Some of my favorite judges are here (e.g., Tacha, Tjoflat, Posner, Richard Arnold, Reinhardt) with, I hope, many more to come.

Scalia and Cheney: Ex parte, or just a party?

The NY Times' Michael Janofsky has a good article in Friday's paper on the ethics fallout from the duck-hunting expedition shared by Associate Justice Antonin Scalia and Vice President Dick Cheney, who is a named party in a major administrative procedure case in which SCOTUS granted review just three weeks before. Senator Patrick Leahy (D.-Vt.) had the best line: "Frankly, I'm puzzled by it. I know Justice Scalia well; he's a very intelligent person. He has to know that with similar tactics, in any state in the country, a State Supreme Court justice would have to recuse himself. It's Law School 101."

New poetry column.

Number 30.

Bush reportedly knew of higher Medicare costs

According to a syndicated article from the Washington Post, GW knew the true price-tag on Medicare reform months ago. So all the time I was writing in this blawg that we can't afford the prescription drug benefit (estimated at the time to cost $400 billion over ten years), the president was laughing up his sleeve because the true cost was estimated to be 33% higher than the White House was admitting? Interesting way to do policy.

Boston-area father wins case against fertility clinic.

As reported in the Boston Globe on Sunday: "In one of the first legal cases in Massachusetts involving the largely unregulated field of fertility treatment, a Middlesex County jury awarded more than $100,000 yesterday to a Dennis man who said that a Boston fertility clinic impregnated his estranged wife without his permission and should pay his share of child support for his now 7-year-old daughter."

Medicare prescription benefit to cost 1/3 more than originally estimated.

It seems like a pittance, really, just a little rivulet pouring into the ocean of red ink produced by this administration. For what it's worth, however, the White House finally came clean and admitted that the price tag on the prescription benefit for Medicare enrollees won't cost $400 billion over ten years, as originally claimed by the Congressional Budget Office, but $530-540 billion instead, which is what the President's proposed budget will reflect. (The New York Times article by Robert Pear is here.) This would be tolerable if the benefits flowed to seniors who need them, but for the most part they don't. Time to break open the bubbly, Big Pharm? This might have been a better deal for you than even your lobbiests were willing to claim, or admit publicly.

Report Assails Hospital Lapses

The L.A. Times today reported a chilling tale of a hospital run amok. According tothe story, "Nurses at Martin Luther King Jr./Drew Medical Center were ordered to lie about patients' conditions, failed to give crucial medications prescribed by doctors and left seriously ill patients unattended for hours — including three who died — according to a new report by federal health officials." The story continues: "[T]he report [is] by the U.S. Centers for Medicare and Medicaid Services, which oversees federal healthcare funding. The document has not yet been released publicly but was obtained by The Times." I will provide a link as soon as one becomes available.

Florida appeals court strikes down state antikickback statute.

This won't have much impact on Texas' AKB law, which slavishly adheres to federal standards, including federal safe harbors. But, for what it's worth, a Florida court has struck down that state's AKB law because it is inconsistent with the federal version. Here's today's Modern Healthcare story:

A Florida appeals court has overturned the state's Medicaid Provider Fraud Statute, calling its antikickback provision unconstitutional. In doing so, the 3rd District Florida Court of Appeal affirmed a judge's ruling in 2000 that the antikickback provision conflicted with the federal law. The Florida law has a different definition of illegal remuneration and does not include safe harbors, the court said. Thus, the state law "criminalizes certain activity that is protected under the federal antikickback statute and stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," the court said. As awareness of healthcare fraud has grown and whistleblower lawsuits have proliferated, many states have passed their own versions of federal antifraud law. Edgar Bueno, a former attorney with HHS' inspector general's office and now in private practice in Fort Lauderdale, Fla., said there's no binding requirement on other states' courts to follow the Florida decision. "But it does set nonbinding legal precedent," Bueno said. "I suspect we'll hear of more state challenges."

The opinion, State v. Hardin (No. 03-0521, Jan. 28. 2004), is here.

F.D.A. Begins Push to End Drug Imports.

The N.Y. Times has a good piece on the FDA's renewed efforts to stop imports of lower-priced drugs from Canada. (The link is the the paper itself, which requires a free subscription, and which will die in a day or two; you might be able to update the link using Google News.)

UK has its own Peter Singer.

The Sunday papers are all carrying a story about the comments of a bioethicist, John Harris, who is a member of the British Medical Association, that he doesn't see a moral distinction between aborting a full-term fetus and infanticide. Pro-life groups are up in arms, though their reaction is somewhat curious. They don't see a moral distinction between aborting a 4-cell embryo and infanticide, so you'd think they would embrace Harris' comments. Fact is, Harris' point is that infanticide isn't that big a deal, once you embrace the morality of late-term abortions, so the pro-lifers can be excused their contradictory response.

Tort reform and malpractice premiums.

From Health Affairs, a very respected health policy journal:

Malpractice Insurance Premiums Lower In States With Caps
On Damage Awards, According To Health Affairs Analysis

But Sharp Increases In Premiums May Not Be Explained
By Lack Of Tort Reform In Many States, Article Contends


BETHESDA, MD — Medical malpractice insurance premiums are 17.1 percent lower in states that have capped court awards, although the lack of such tort reform measures in other states does not fully explain recent jumps in what physicians pay to cover the cost of malpractice suits, according to a new analysis published on the Health Affairs Web site, www.healthaffairs.org.

Kenneth E. Thorpe, chairman of the health policy and management department at the Emory University Rollins School of Public Health, examines the effects of recent sharp increases in malpractice premiums in many states and states’ efforts to keep malpractice premiums down. Malpractice premiums increased by 23.2 percent in 2002, although the increases varied by state and specialty.

Awards caps exist in 24 states and are the only malpractice reform efforts that have affected physicians’ premiums, reducing them 17.1 percent. While Thorpe says that such measures extended to other states or nationally through a federal law “would ultimately result in lower premiums,” he questions whether taking that step would accomplish the goals of the liability system.

“At issue is whether we should adopt short-term, stopgap solutions to slow the growth in premiums, or use the recent experience to more fundamentally evaluate and perhaps reform the liability system,” Thorpe says. “The results suggest that capping awards may improve the profitability of malpractice carriers and reduce premiums. Whether this is socially desirable or improves the goals of deterrence and compensation remains an open question.”

Three factors have been the principal drivers of malpractice premiums: growing awards and settlements, increased frequency of lawsuits, and declines in investment income. By 2002 every premium dollar collected resulted in $1.29 in total expenses, awards, and settlements, up from 95 cents of total expenses in 1995, Thorpe writes.

Meanwhile, investment earnings have dropped steadily, from 49 percent of premium income 1995 to 18 percent in 2002. Combined, those trends yielded an industrywide net after-tax loss of 11 percent in 2002.

Also disrupting the market has been the bankruptcy of some malpractice insurance carriers and the decisions of others to stop writing policies in some states or withdraw from the business altogether. Thorpe identifies a correlation between the reduction of competition and higher premiums in some states.

Thorpe questions whether the recent increases in malpractice premiums constitute a crisis or simply standard fluctuations in the insurance markets.

“Rising claims costs may reflect a rise in underlying negligence,” Thorpe says. “If true, the system may be functioning as designed, and the spike in premiums may provide stronger incentives to improve the quality of care provided.

“On the other hand, we may be observing a permanent rise in claims payments and costs unrelated to trends in physician negligence,” he says. “At issue is the extent to which the underlying factors generating higher premiums are following a traditional cyclical insurance pattern, or whether a structural change has occurred in severity and frequency.”

To view the article, click here.

Health law and policy

Interesting book review in tomorrow's JAMA:
The Privatization of Health Care Reform: Legal and Regulatory Perspectives
edited by M. Gregg Bloche, 220 pp, $39.95, ISBN 0-19-510868-X, New York, NY, Oxford University Press, 2003.
JAMA. 2004;291:375.

The reviewer is Ronald Andersen, PhD, UCLA School of Public Health. Apparently no fan of the role of health law (or health lawyers?) on the health care system, Andersen concludes his review:

Bloche concludes, "Scholarship that concedes the health sphere's complexities and seeks remedies that fit this country's legal, political and cultural constraints can contribute to reasoned regulatory governance." Again, he may be right. Still, I am left with the troubling suspicion that by narrowly focusing on health law's role in reform of the medical marketplace the book may be seeking to make the proverbial "silk purse out of a sow's ear."

The book itself sounds like it might be a good read:

The failure of President Clinton's health reform plan in 1994 was followed by multiple efforts at market-driven reform in the US health services system. This book is about those efforts. . . .

The authors start from the premise that systematic, state-sponsored overhaul of the US system is unlikely in the foreseeable future. . . .

Much of the market-driven reform over the past 10 years has been the efforts of managed care plans to control costs through preauthorization review of proposed treatments, selective affiliation with frugal providers, bargaining for discounted payment rates, and financial incentives to physicians to limit spending. Challenges to these managed care cost control efforts by consumers and providers and the law's treatment of these challenges is the main focus of the book. The authors provide some in-depth understanding of some of the managed care revolution's failings and the law's relationship to these failings. Some of the authors consider law as a cause of market failure while others examine the law's potential and limitations to correct market failure.

The legal/regulatory areas that are the book's main focus include "the power of the state vs the federal government in making rules for the medical marketplace; conflicts between insurers and patients and providers regarding what constitutes medical need; how financial rewards to physicians for frugal practice influence their medical decisions; the role of antitrust law in the organization of health care provision and financing; privatization as a solution to bureaucratic and legal rigidities in public hospitals; and the case against tax and regulatory preferences for the nonprofit form over investor ownership in the hospital and health insurance sectors."

Andersen's main beef seems to be his disagreement over the book's focus on private market-driven reforms to the exclusion of top-down reforms: "Nonetheless, I believe that failure of the market-driven mechanisms to provide universal access to care, control costs, or 'empower the consumer' suggests that attention in the book to other approaches to system reform might still have been warranted." But that, as the saying goes, would have been a different book.

Congressional Budget Office doubts economic impact of tort reform on health costs.

As we've, ahem, been saying here all along, tort reform is not the way to get a handle on rising health care costs. Now the bipartisan Congressional Budget Office is saying it, in a report ("Limiting Tort Liability for Medical Malpractice," Jan. 8, 2004) that offers the following key observation:

Evidence from the states indicates that premiums for malpractice insurance are lower when tort liability is restricted than they would be otherwise. But even large savings in premiums can have only a small direct impact on health care spending—private or governmental—because malpractice costs account for less than 2 percent of that spending. Advocates or opponents cite other possible effects of limiting tort liability, such as reducing the extent
to which physicians practice “defensive medicine” by conducting excessive procedures; preventing widespread problems of access to health care; or conversely, increasing medical injuries. However, evidence for those other effects is weak or inconclusive.

The point about the lack of a correlation between tort reform and reduced pressure to practice defensive medicine deserves an additional comment, which appears later in the brief:

Proponents of limiting malpractice liability have argued that much greater savings in health care costs would be possible through reductions in the practice of defensive medicine. However, some so-called defensive medicine may be motivated less by liability concerns than by the income it generates for physicians or by the positive (albeit small) benefits to patients.

The report comes too late to save Texan from Proposition 12, which voters approved last fall, but at least we now have CBO support for the idea that the legislature sold them a pig in a poke.

Institute of Medicine report: US should aim for universal coverage by 2010.

The IOM has added its voice to the steadily rising chorus calling for aggressive steps to cover all Americans (including the 43 million currently uninsured) by 2010. Its report, "Insuring America's Health," can be found on-line, as can summaries of its major findings and statistics. Fact Sheet 4 is an eye-opener: Your chances of being uninsured are higher in Texas than in any other state in the Union (28.4%). As for the impact of this initiative on public budgets, universal coverage would probably save money in the long run. Besides, considering the impact on the health, the lives, and the future of children (who account for half the uninsured), it's the right thing to do!

Emily Dickinson.

Margo Jefferson has a nice end-piece in today's NY Times Book Review ("I Don't Know How She Does It") about Emily Dickinson and the various men who are mostly on display in a recent PBS documentary on the Belle of Amherst. She might as well have named the essay "I Don't Know Why Men Don't Get It." The director/writer Jim Wolpaw takes a couple of direct hits, and Billy Collins gets swiped, too, for his poem, "Taking Off Emily Dickinson's Clothes," which Ms. Jefferson describes as "smarmy." Maybe I like Billy Collins' stuff too much, or perhaps Margo Jefferson likes it too little, but I think his agenda is actually the same as hers: Get past the "blessed virgin" image of the Belle and try to understand that she was a flesh-and-blood creature who did not shrink from the world in all its power and fury and unknowable bleakness and stark beauty. Or something like that.