McCain threatens to stall CMS head.

The Hill is reporting that Mark McClellan's nomination, which would move him from his current position as FDA Administrator to head of the Centers for Medicare and Medicaid Services, may be held up by Sen. John McCain unless McClellan starts answering McCain's questions about the FDA's intransigence on the issue of prescription drug imports from Canada. McCain, whose relationship with the Bush administration is strained at best, says he wouldn't necessarily put a hold on the nomination. Part of the problem may be Senatorial pique: McClellan was a no-show on two occasions when invited to the Hill to defend the FDA's anti-importation stance.

But Robert Pear is reporting in Wednesday's N.Y. Times that Sens. Byron Dorgan (D.-N.D.) and Debbie Stabenow (D.-Mich.) are considering holds of their own until they get some satisfaction from McClellan on the FDA's position.

Constitutional conundrum.

President Bush today threw his support behind a constitutional amendment that would make it clear that "marriage" can only be between one man and one woman. Here are his remarks:

Thank you. Please be seated. Good morning. Eight years ago, Congress passed, and President Clinton signed, the Defense of Marriage Act, which defined marriage for purposes of federal law as the legal union between one man and one woman as husband and wife. The act passed the House of Representatives by a vote of 342-67 and the Senate by a vote of 85-14.

Those congressional votes, and the passage of similar defense of marriage laws in 38 states, express an overwhelming consensus in our country for protecting the institution of marriage. In recent months, however, some activist judges and local officials have made an aggressive attempt to redefine marriage. In Massachusetts, four judges on the highest court have indicated they will order the issuance of marriage licenses to applicants of the same gender in May of this year.

In San Francisco, city officials have issued thousands of marriage licenses to people of the same gender, contrary to the California Family Code. That code, which clearly defines marriage as the union of a man and a woman, was approved overwhelmingly by the voters of California. A county in New Mexico has also issued marriage licenses to applicants of the same gender. And unless action is taken, we can expect more arbitrary court decisions, more litigation, more defiance of the law by local officials, all of which adds to uncertainty.

After more than two centuries of American jurisprudence and millennia of human experience, a few judges and local authorities are presuming to change the most fundamental institution of civilization. Their actions have created confusion on an issue that requires clarity. On a matter of such importance, the voice of the people must be heard.

Activist courts have left the people with one recourse. If we're to prevent the meaning of marriage from being changed forever, our nation must enact a constitutional amendment to protect marriage in America.

Decisive and democratic action is needed because attempts to redefine marriage in a single state or city could have serious consequences throughout the country. The Constitution says that full faith and credit shall be given in each state to the public acts and records and judicial proceedings of every other state.

Those who want to change the meaning of marriage will claim that this provision requires all states and cities to recognize same-sex marriages performed anywhere in America. Congress attempted to address this problem in the Defense of Marriage Act by declaring that no state must accept another state's definition of marriage. My administration will vigorously defend this act of Congress. Yet there is no assurance that the Defense of Marriage Act will not itself be struck down by activist courts.

In that event, every state would be forced to recognize any relationship that judges in Boston or officials in San Francisco choose to call a marriage. Furthermore, even if the Defense of Marriage Act is upheld, the law does not protect marriage within any state or city.

For all these reasons, the defense of marriage requires a constitutional amendment. An amendment to the Constitution is never to be undertaken lightly. The amendment process has addressed many serious matters of national concern, and the preservation of marriage rises to this level of national importance. The union of a man and woman is the most enduring human institution, honored and encouraged in all cultures and by every religious faith. Ages of experience have taught humanity that the commitment of a husband and wife to love and to serve one another promotes the welfare of children and the stability of society.

Marriage cannot be severed from its cultural, religious and natural roots without weakening the good influence of society. Government, by recognizing and protecting marriage, serves the interests of all.

Today, I call upon the Congress to promptly pass and to send to the states for ratification an amendment to our Constitution defining and protecting marriage as a union of a man and woman as husband and wife.

The amendment should fully protect marriage, while leaving the state legislatures free to make their own choices in defining legal arrangements other than marriage. America's a free society which limits the role of government in the lives of our citizens. This commitment of freedom, however, does not require the redefinition of one of our most basic social institutions.

Our government should respect every person and protect the institution of marriage. There is no contradiction between these responsibilities. We should also conduct this difficult debate in a matter worthy of our country, without bitterness or anger. In all that lies ahead, let us match strong convictions with kindness and good will and decency

First, has the president thrown his support behind the constitutional amendment currently pending before before both houses of Congress (S.J. Res. 26; H.J. Res. 56)? I don't believe so. It provides:

SJ 26 IS

108th CONGRESS

1st Session

S. J. RES. 26

Proposing an amendment to the Constitution of the United States relating to marriage .

IN THE SENATE OF THE UNITED STATES

November 25, 2003

Mr. ALLARD (for himself, Mr. BROWNBACK, Mr. SESSIONS, Mr. BUNNING, and Mr. INHOFE) introduced the following joint resolution; which was read twice and referred to the Committee on the Judiciary

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

JOINT RESOLUTION
Proposing an amendment to the Constitution of the United States relating to marriage .

Resolved by the Senate and House of Representatives of the United States of America in Congress assembled (two-thirds of each House concurring therein), That the following article is proposed as an amendment to the Constitution of the United States, which shall be valid to all intents and purposes as part of the Constitution when ratified by the legislatures of three-fourths of the several States within seven years after the date of its submission by the Congress:

`Article--

`Marriage in the United States shall consist only of the union of a man and a woman. Neither this Constitution, nor the Constitution of any State, nor State or Federal law, shall be construed to require that marital status or the legal incidents thereof be conferred upon unmarried couples or groups.'.

As I read it, the amendment would ban same-sex marriage and civil union statutes such as Vermont's, and Bush said the amendment should "leav[e] the state legislatures free to make their own choices in defining legal arrangements other than marriage." But who knows? Maybe the president's call for an amendment will end up prohibiting civil unions, as well, whether he intends that result or not.

Second, is such an amendment a good thing or a bad thing for federalism? Is this an example of the federal government taking control of a state-law issue and shoving a single, one-size-fits-all answer down the throats of all 50 states? Or is this an example of appropriate federal protection for a social norm that has broad majority support at the state level? On the federalism point, it's been argued that there will be a federal answer sooner or later, either from the Supreme Court (interpreting the due process clause (Vth and XIVth Amendments) or the equal protection clause (XIVth Amendment) or from an amended constitution, so what's really wrong with the president jumping in there with a constitutional amendment before the issue gets to SCOTUS? But that argument gives away too much. Certainly one federalist response to the Massachusetts Supreme Judicial Court and to San Francisco's mayor would be to say that the federal constitution doesn't speak to these issues at all, so it's up to each state to figure out what its marriage rules should be. Another federalist response, if Bush cared at all about state's rights, would be a call for an amendment that put the Defense of Marriage Act (i.e., "no state is required to recognize a same-sex marriage that is legal in another state") into the constitution and leave it at that. But Bush's call is much broader than that.

Third, wouldn't Bush's amendment be a Romer-like statement of political animus against a group of citizens without parallel in our federal constitution since the repeal of Article I, sec. 2, cl. 3 by the XIVth Amendment? Put otherwise, I never thought I'd live to see a President of the United States propose a constitutional amendment that was so blatantly bigoted and discriminatory.

Do physicians have a duty to treat during epidemics?

I recently wrote (in an editorial for the Pediatric Infectious Disease Journal) that they do, but not beyond the point where heroism turns into martyrdom. There's a nice piece on the web site of the American Journal of Bioethics by Samuel Huber and Matthew Wynia that reaches about the same conclusion but develops the historical, social, and ethical themes at greater length than I did in my short piece. Here's the abstract:

The threat of bioterrorism, the emergence of the SARS epidemic, and a recent focus on professionalism among physicians, present a timely opportunity for a review of, and renewed commitment to, physician obligations to care for patients during epidemics. The professional obligation to care for contagious patients is part of a larger "duty to treat," which historically became accepted when 1) a risk of nosocomial infection was perceived, 2) an organized professional body existed to promote the duty, and 3) the public came to rely on the duty. Physicians' responses to epidemics from the Hippocratic era to the present suggests an evolving acceptance of the professional duty to treat contagious patients, reaching a long-held peak between 1847 and the1950's. There has been some professional retrenchment against this duty to treat in the last 40 years but, we argue, conditions favoring acceptance of the duty are met today. A renewed embrace of physicians' duty to treat patients during epidemics, despite conditions of personal risk, might strengthen medicine's relationship with society, improve society's capacity to prepare for threats such as bioterrorism and new epidemics, and contribute to the development of a more robust and meaningful medical professionalism.

The full piece is well worth reading . . .

Sierra Club files motion with full Court to have Scalia recused from Cheney's case.

The Sierra Club has taken the unusual, and usually futile, step of filing a motion with the full Court to get Justice Scalia recused from the Cheney case based upon his January duck-hunting trip with the Vice President, according to an Associated Press article filed by Gina Holland. It's unusual because the Supreme Court's Rule 21 -- which Sierra presumably invoked -- governs motions to the Court, while recusal motions are traditionally handled with a motion to the individual justice pursuant to Rule 22. The existence and rationale for this tradition are covered well today in Goldstein Howe's SCOTUSblog, and as recently as January 26th, CNN reported that Chief Justice Rehnquist dismissed senators' calls for recusal as "ill considered": "'It has long been settled that each justice must decide such a question for himself,' he said, although he added that justices often consult among themselves when such issues are raised."

Sierra Club hires savvy lawyers who know the odds. They have to know that the Court is not going to grant their motion and is likely not even to consider it on its merits. And despite the public comments of Scalia himself (at Amherst College on Feb 10: "It's acceptable practice to socialize with executive branch officials when there are not personal claims against them. That's all I'm going to say for now. Quack, quack."), SC must be thinking that Scalia will surely bow to the rising tide of calls for him to recuse himself (unlikely), and failing that, that the full Court will "consult among themselves" -- including Justice Scalia -- on the subject. (And never let it be said that the Sierra Club's motives are pure. They desperately want Scalia out of the case because they predict his will be a vote against their likely position on the merits, which has less to do with the National Energy Policy Cheney produced than it does the process by which the policy was developed and the authority of the federal district court to compel the Vice President to comply with discovery requests concerning that process.) As much as Scalia would not want to appear to be bowing to public pressure to bow out, he could change his mind for the good of the Court, and no one would think any less of him.

Concierge medicine now supported by trade association.

As reported in today's "Daily Dose" from Modern Healthcare,

A new national organization has been formed to serve as an advocate and information clearinghouse for practitioners of concierge medicine -- a controversial model of patient care that usually requires patients to pay an annual membership fee for such perquisites as customized-care plans and round-the-clock access to doctors. Officials with the not-for-profit American Society of Concierge Physicians said doctors in about two dozen states now offer some form of concierge service but remain a small fraction of all practicing physicians. An ASCP spokeswoman said the group has 26 members, representing "10% to 20%" of doctors involved in concierge services. John Blanchard, president and co-founder of the group and founder of Premier Private Physicians in Detroit, said he expects the number of physicians involved in concierge services to grow dramatically in the next several years because the model "allows (doctors) to practice medicine the way it was intended to be practiced -- with the patient as the focus." The organization has scheduled its first annual conference for May 27 and 28 in Denver, where about 20 practitioners from across the country will discuss ethical, legal, regulatory and social issues surrounding retainer-based practices.

Membership in the ASCP requires payment of a $500 fee; the application form doesn't say whether this is an annual or one-time fee.

For the time being, CMS is taking no position as to whether retainers paid to physicians to secure preferential treatment constitute "balance billing" or "private contracts" under Medicare law. A plausible argument could be made either way, but if CMS were to take the position that the retainers were either one, that would be a serious blow to the concierge-medicine movement. "Balance billing" is limited to 109.25% of the Medicare approved amount for covered services; presumably concierge retainers are significantly in excess of that amount. "Private contracting" is permitted under the Medicare law, but it requires that the physician agree not to bill Medicare for any covered services for any Medicare beneficiaries (not just the one with whom the private contracted is entered into) for a period of three years. There are some specialties that can afford to take the hit (i.e., those with relatively few Medicare beneficiaries and those with a high percentage of services that are not covered by Medicare), but many can not. A Feb. 2004 publication (Physician's News Digest) does a nice job of reviewing the developments from the AMA (so far, the practice is deemed to be not inconsistent with their ethics opinions, which are supportive of diversity and innovation in the delivery of physicians' services, as long as certain guidelines (adopted by the Council on Ethical and Judicial Affairs at its June 2003 meeting) are adhered to).

The most sustained criticism of concierge medicine is from Troy Brennan (faculty member at Harvard's Medical School, School of Public Health, and Law School ("Luxury Primary Care -- Market Innovation or Threat to Access?" N. Eng. J. Med. 2002;346:1165-1168) (requires subscription), who identifies a number of ethical concerns with concierge medicine: (1) transitioning from a standard to a concierge practice may result in the abandonment of existing patients or in a diminished quality of care; (2) concierge medicine undermines the cross-subsidization of care for patients with lousy insurance or no health insurance at all; and (3) by allowing physicians to focus on the needs of a relatively small patient population defined by their ability to pay fairly steep retainers, the practice could exacerbate inequities in access to care that already exist. Of course, the flip side, as Brennan concedes, is that the development of concierge medicine may be the crystallizing event that leads organized medicine to examine more seriously than it has to date the myriad ways in which financial inequities limit access to care and to start addressing them in a concerted fashion.

Appellate advocacy at its finest.

For all the 1L's in my Constitutional Law class, preparing their briefs for moot court and anticipating the day they will get up and argue their first (moot) case, here's a keeper from Howard Bashman's "How Appealing" blog:

The perils of an advocate's trying to replicate an allegedly hostile work environment from the lectern at the start of an appellate oral argument: Today in the U.S. Court of Appeals for the Seventh Circuit, a three-judge panel consisting of Circuit Judges Richard D. Cudahy, Richard A. Posner, and Ilana Diamond Rovner [by the way, none of these links appears to be working, but I'm including them from the original post, just in case the problem is only temporary] heard oral argument in the case of Leslie D. McPherson v. City of Waukegan. The attorney for plaintiff-appellant McPherson began his oral argument as follows:

My name is Jed Stone, and I represent the appellant Leslie McPherson.

"What color is your bra? Does it match your panties?"

Immediately thereafter, Judge Rovner interjected:

Are you speaking to Judge Posner?

The courtroom erupted in laughter. You can download the audio of the oral argument via this link (right-click to save MPG audio file to your computer's hard drive before playing audio). Thanks so very much to the reader who emailed to bring this oral argument from earlier today to my attention.

If you listen to the sound clip, check out Mr. Stone's seamless recovery . . .

Other blawgers.

Life being nasty, brutish, and - most importantly for present purposes - short, I rarely get to visit the blawgs listed to the left of this post. But a few minutes at Jack Balkin's blawg yielded two nice pieces that relate to what we are doing in Con Law these days. First, a critique (or, a link to a critique) of the Federal Marriage Amendment's sloppy drafting. Second, a quick hit on the questionable and opportunistic originalism of Justice Scalia.

Anatomy of hope - Jerome Groopman.

I'm working on my own review of Jerome Groopman's new book, The Anatomy of Hope, but meanwhile the N.Y. Times has beaten me to the punch with a review in today's Books section. Groopman, an oncologist at Harvard and the model for ABC's short-lived series, "Gideon's Crossing" (based on his first two books: The Measure of Our Days and Second Opinions), also writes for The New Yorker. His clinical narratives are gems that should be required reading for all medical students and residents. Happily, his New Yorker essays -- which are a nice blend of clinical writing and policy musings -- are collected on his web site.

Running a hospital by the numbers . . . and quality of care.

The Sunday N.Y. Times has an article by Andrea Gabor that describes the turnaround at St. Joseph Health Center in suburban St. Louis. The bottom line is looking better (from losses a few years ago to a modest net revenue of $17 million on $1.8 billion in gross revenues), quality measures are up, and nurse turnover is down. And the key appears to be the dreaded "cookie-cutter" management controls so hated by clinicians. The key seems to be to create a systems approach that focuses on quality and safety, even when it increases costs, because the savings to the hospital are even greater, at least when the investment is focused on achievable advances.

Supreme Court to hear 'dirty bomb' suspect's appeal.

SCOTUS agreed yesterday to review Jose Padilla's case (see CNN's report). The Court's order contains an expedited briefing schedule, presumably to allow it to be argued the same day as the detention case brought by Yaser Hamdi (U.S. No. 03-6696). Other good reviews of the case and the issues it raises are in today's Boston Globe, N.Y. Times, and Washington Post.

This brings to three the number of cases on SCOTUS' docket involving the detention of "enemy combatants" in connection with the prosecution of the war in Afghanistan or pursuant to President Bush's Nov. 13, 2001, Military Order. (Read the order at 66 Fed. Reg. 57833 (Nov. 16, 2001); text version loads faster). Here's the dope on all three cases (docket no., caption, link to ruling below, documents in case (where available)):

• 03-1027 - Rumsfeld v. Padilla [American citizen's challenge to military detention] - 2nd Cir. opinions (majority)(concurring & dissenting)
  
• 03-0334 / 03-0343 - Rasul v. Bush / Al Odah v. U.S. [foreign nationals' challenge to Guantanamo Bay detentions] - D.C. Circuit opinion; case documents


• 03-6696 - Hamdi v. Rumsfeld [military detention in Virginia of presumed American citizen captured in Afghanistan] - 4th Cir. opinion

States looking into screening Canadian pharm imports.

As reported in today's N.Y. Times, Minnesota and Wisconsin will soon ask other states to join them in screening Canadian drug imports. The effort is an attempt to counter safety warnings from the FDA, which has been an implacable foe of importing the lower-cost drugs from our neighbors from the north. Just yesterday, the FDA sent a warning letter to yet another pharmacy (this one is in West Virginia) that allegedly helps its customers obtain drugs from Canadian sources. The FDA's web page re: imported foreign prescription drugs is here. It collects all the agency's regulatory policy statements on the issue, consumer alerts, news summaries, etc.

San Francisco Judge Rules Gay Marriages Can Continue

The NY Times will report on Saturday that "[o]pponents of gay marriage suffered another setback here [San Francisco] on Friday when a judge refused to block the issuance of same-sex marriage licenses, saying the opponents had not shown that the weddings were causing immediate harm." Moreover: "Some judicial experts said that the moves in San Francisco and New Mexico indicated the debate over the licenses was becoming more rooted in legal, not political, ground." For more legal analysis, with an emphasis on the con law aspects of the debate, you could do worse than to start with Larry Lessig's blog on this.

Schiavo update.

After many months and many posts (see here and here, among many others), the Terri Schiavo case is resurfacing. Here's a good editorial from today's Palm Beach Post.

Testing Toxics on Humans Is Ethical, Science Panel Says (washingtonpost.com).

As reported in the Washington Post, a panel of scientists from the National Academy of Sciences issued a report yesterday that says it is ethical to test pesticides and other toxic substances on human subjects to determine whether environmental safety standards can be lowered: "Many scientists and ethicists have argued that such research is never justified, and yesterday's unprecedented verdict by the National Academy of Sciences took environmentalists by surprise."

The ethical analysis is summarized thusly: "While volunteers would derive no benefit and some might incur transient harm, the panel of experts said this would be outweighed by societal benefits. Besides helping regulators set accurate benchmarks for environmental dangers, such trials might also address, for example, how much insecticide can safely be used to fight a malaria outbreak." As politicized and polarized as the debate has been over this kind of testing, the esteemed co-chair of the panel, Jim Childress of the University of Virginia, observed: "While there was no 'foolproof mechanism' to eliminate all risk of patient harm, [the risk for volunteers would generally be] exceedingly low."

What's next? --

Yesterday's decision by a panel of the National Research Council will allow the Environmental Protection Agency to devise a final rule over the next several months, an EPA spokesman said. Both the pesticide industry and environmental groups said they expect the agency will accept the recommendation of the panel, which would also allow the EPA to evaluate human studies of pesticides that had previously been conducted, and give the industry an incentive to conduct new trials.

The panelists called for a rigorous safety and ethics system to evaluate and approve such trials, much like the system used by the Food and Drug Administration to evaluate drug trials conducted by the pharmaceutical industry.

The report allowed for the possibility of trials involving children, but panelists said they could not imagine such tests would ever be conducted. But Erik Olson, senior attorney at the Natural Resources Defense Council, an environmental group, said such tests have already been performed: As recently as 2000, he said, a manufacturer petitioned the EPA to consider data from an Italian study of infants that deliberately exposed them to dichlorvos, an insecticide sold under the brand name Vapona."

The prepublication version of the report can be found on the NAS website. The news release is here.

HHS to AHA: discounting care for the uninsured doesn't violate federal law.

Today HHS Secretary Tommy Thompson released a letter to the president of the American Hospital Association, Richard Davidson, in which Thompson wrote:

[H]ospitals can provide discounts to uninsured and underinsured patients who cannot afford their hospital bills and to Medicare beneficiaries who cannot afford their Medicare cost-sharing obligations. Nothing in the Medicare program rules or regulations prohibit such discounts. In addition, the Office of Inspector General informs me that hospitals have the ability to offer discounts to uninsured and underinsured individuals and cost-sharing waivers to financially needy Medicare beneficiaries.

Thompson went on to write: "To be sure that there will be no further confusion on this matter, at my direction, the Centers for Medicare & Medicaid Services and the Office of Inspector General have prepared summaries of our policy that hospitals can use to assist the uninsured and underinsured." I'm looking for those summaries and will provide a link as soon as they show up on the HHS web site.

Paul Krugman: The Health of Nations

Paul Krugman's op-ed piece in today's N.Y. Times is the first in what I can only hope will be many articles on the Bush administration's political vulnerabilities in the health care arena. Don't get me wrong: the mess we are in is not exactly the Bush administration's doing, not all of it anyway. We've been on a collision course with reality since 1965, some would argue since Teddy Roosevelt's Bull Moose plank in favor of a national, single-payer system was rejected at the beginning of the 20th century. But Bush's economic report has nothing useful to say to the 40 million uninsured or to the many millions of others who are periodically uninsured or chronically underinsured. Speaking of the nature of the problem and the vacuousness of the administration's response, Krugman concludes:

The result is that American health care, which at its best is the best in the world, offers much of the population a worst-of-all-worlds combination of insecurity and high costs. And that combination is getting worse: insurance premiums are rising, and companies are becoming increasingly unwilling to offer insurance to their employees.

What would an answer to the growing health care crisis look like? It would surely involve extending coverage to those now uninsured. To keep costs down, it would crack down both on drug prices and on administrative costs. And it might well cut private insurance companies out of the loop for some, if not all, coverage.

But the administration can't offer such an answer, both because of its ideological blinders and because of its special interest ties. The Economic Report of the President has only negative things to say about efforts to hold down drug prices. It talks at length about insurance reform, but it mainly complains that we rely too much on insurance; it says nothing about either expanding coverage or reducing insurance-company overhead. Its main concrete policy suggestion is a plan for tax-deductible health savings accounts, which would be worth little or nothing to a vast majority of the uninsured.

I'll talk more about alternatives for health care in future columns. But for now, let's just note that this is an issue the public cares about — an issue the administration can't address, but a bold Democrat can.

Placebos - ethical and effective ways of giving them

Accprding to Medical News Today, Howard Brody is lecturing about ethical and effective ways of giving placebos:

"This new way of thinking defines the placebo effect as a special kind of mind-body interaction that occurs in a health-care setting," Brody said.

"Doctors may never prescribe placebos – dummy pills – but can make use of the placebo effect every time they see a patient. Seeing that the 'placebo effect' does not depend on the 'placebo' is key to making use of its healing potential in an ethical way.

"Features of the healing environment usually include a physician or healer that listens carefully to what you say and gives you a realistic and sound explanation of what is happening to you," he said.

"People express care and compassion for your fears and suffering, and you leave feeling more in control of your life and your illness."

In addition, Brody said evidence exists that creating positive feelings in the health care environment goes a long way in treating a patient.

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.

The Constitution and the war on terrorism (II).

The last time Tony Lewis wrote an op ed for his old employer, The New York Times, before today (see below) it appeared in the paper on February 24, 2003, the 200th anniversary of the Supreme Court's opinion in Marbury v. Madison (click here for full opinion). For purposes of my con law class, at least, it does a very nice job of tying together Marbury (which we will begin discussing on Jan. 21) and the Quirin and Johnson cases (yesterday's class). For a critical view of Lewis' op ed article by a former Supreme Court law clerk (who mysteriously remains nameless), click here (Howard Bashman's "How Appealing" blawg).

The Constitution and the war on terrorism (I).

Anthony Lewis's op ed in today's N.Y. Times is (i) a wonderful reminder of how valuable Lewis' voice has been (and occasionally continues to be) in the national debate over the role of the Constitution in our public and private lives and (ii) a very nice summary of the Supreme Court's terrorism cases. For my con law class, it should help put the Appendix C cases of Ex parte Quirin and Johnson v. Eisentrager in perspective. The University of Chicago Law School has put together a fine web page in connection with a January 17 (2002?) panel discussion there on military tribunals.

Unanimous Supreme Court victory for the children of Texas.

I can't remember the last time the Supreme Court justices all agreed in an Eleventh Amendment case, but it happened yesterday in Frew v. Hawkins (U.S., No. 02-628, Jan. 14, 2004). Bottom line: Texas officials must abide by a consent decree to which they consented in 1996 to increase spending on the Medicaid program's Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program. Legally, the case involves an interesting question whether federal courts can compel a state to adhere to the terms of such a consent decree consistent with the Eleventh Amendment, which in a number of analgous situations has been held to shield states from federal court actions for money damages. I say it's "interesting" because -- despite the Court's unanimous opinion -- it's an arguable point. In this case, the trial judge rejected Texas' Eleventh Amendment argument. On appeal, however, the conservative Fifth Circuit Court of Appeals bought the state's argument. But politically and morally, it's hard to see how Texas' position was anything but crass, cold-hearted, underhanded, and punitive. Here's the syllabus of the Court's opinion:

As a participant in the Medicaid program, Texas must meet certain federal requirements, including that it have an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) program for children. The petitioners, mothers of children eligible for EPSDT services in Texas, sought injunctive relief against state agencies and various state officials, claiming that the Texas program did not meet federal requirements. The claims against the state agencies were dismissed on Eleventh Amendment grounds, but the state officials remained in the suit and entered into a consent decree approved by the Federal District Court. In contrast with the federal statute’s brief and general mandate, the decree required state officials to implement many specific proposals. Two years later, when the petitioners filed an enforcement action, the District Court rejected the state officials’ argument that the Eleventh Amendment rendered the decree unenforce-able, found violations of the decree, and directed the parties to submit proposals outlining possible remedies. On interlocutory appeal, the Fifth Circuit reversed, holding that the Eleventh Amend-ment prevented enforcement of the decree because the violations of the decree did not also constitute violations of the Medicaid Act. Held: Enforcement of the consent decree does not violate the Eleventh Amendment.

(a) This case involves the intersection of two areas of federal law: the Eleventh Amendment and the rules governing consent de-crees. The state officials argue that a federal court should not enforce a consent decree arising under Ex parte Young, 209 U. S. 123, unless it first identifies, at the enforcement stage, a violation of federal law such as the EPSDT statute itself. This Court disagrees. The decree here is a federal court order that springs from a federal dispute and furthers the objectives of federal law. Firefighters v. Cleveland, 478 U. S. 501, 525. The petitioners’ enforcement motion sought a remedy consistent with Ex parte Young and Firefighters and accepted by the state officials when they asked the court to approve the consent decree. Pennhurst State School and Hospital v. Halderman, 465 U. S. 89, in which this Court found Ex parte Young’s rationale inapplicable to suits brought against state officials alleging state-law violations, is distinguishable from this case, which involves a federal decree entered to implement a federal statute. Enforcing the decree vindicates an agreement that the state of-ficials reached to comply with federal law. Federal courts are not reduced to approving consent decrees and hoping for compliance. Once entered, that decree may be enforced. See Hutto v. Finney, 437 U. S. 678.

(b) The state officials and amici state attorneys general express le-gitimate concerns that enforcement of consent decrees can undermine sovereign interests and accountability of state governments. How-ever, when a consent decree is entered under Ex parte Young, the response to their concerns has its source not in the Eleventh Amend-ment but in the court’s equitable powers and in the direction given by Federal Rule of Civil Procedure 60(b)(5), which encompasses an equity court’s traditional power to modify its decree in light of changed circumstances. See, e.g., Rufo v. Inmates of Suffolk County Jail, 502 U. S. 367. If a detailed order is required to ensure compliance with a decree for prospective relief that in effect mandates the State to ad-minister a significant federal program, federalism principles require that state officials with front-line responsibility for the program be given latitude and substantial discretion. The federal court must en-sure that when the decree’s objects have been attained, responsibility for discharging the State’s obligations is returned promptly to the State and its officials. The basic obligations of federal law may re-main the same, but the precise manner of their discharge may not. If the State establishes reason to modify the decree, the court should make the necessary changes; otherwise, the decree should be en-forced according to its terms. 300 F. 3d 530, reversed.

This litigation started in 1993, based upon the plaintiffs' claim that Texas has dealt children in desperately poor families a really lousy hand, in violation of their federal-law obligations. If the plaintiffs were right (and I suppose we won't know, technically, since there was no trial and therefore no findings of fact on the underlying claims), it's been over a decade now that these kids have been denied services required by federal law. Perhaps this disgraceful record on children's health is about to come to an end.

Ambiguous Gifts: When Patients Give and Doctors Take

Good article by Denise Grady on VIP patients, gifts from patients, George Harrison's signed guitar, and the morally ambiguous topic of physicians and hospitals who profit from their association with the rich and famous.

Seniority: Two Holes in the Medicare Drug Law/

Finally, somebody is asking the questions that need to be asked about the Medicare reform law signed by
Dubyah last month. In an article in today's NY Times, Fred Brock asks:

What impact will it have on pharmaceutical companies' programs that offer free drugs to low-income people, including those on Medicare? Why does the law prohibit beneficiaries from buying private insurance to cover the considerable gaps in coverage?

As for the first question:

The drug companies themselves are struggling with the first question, as is their trade group in Washington, the Pharmaceutical Research and Manufacturers of America. But one thing is clear: if the companies do not change their requirements by 2006, thousands of older low-income Americans will lose access to free or nearly free drugs. That's because participants in the programs generally must not have any drug coverage or access to it. Of course, they will have access to drug coverage in 2006 - although with coverage gaps that could cost thousands of dollars a year.

The free-drug programs are crucial for many recipients. The income limits are not that strict: in some cases, people earning up to $50,000 a year can qualify. The drugs are commonly dispensed through doctors or via discount cards; patients usually have to requalify regularly and apply separately to each company that makes the drugs they need.

I am particularly interested in that second question:

The prohibition against buying private insurance, meanwhile, will hit middle-income people the hardest. "Many people will be forced to put out their own money, even if they want to buy insurance," Mr. Hayes [president of the nonprofit Medicare Rights Group] said.

A report accompanying the final Medicare bill when it was passed last year said the insurance prohibition was to keep beneficiaries from becoming "insensitive to costs." Well, if your mother needs a prescription, her "sensitivity" is not going to lessen her need, but the cost may lessen her ability to buy it. And why shouldn't she be allowed to buy private insurance to help if she wants to? By that logic, should we prohibit auto insurance to make people sensitive to high repair costs?

Some administration and Congressional officials argue that older Americans would consume less health care if they had to pay more for it, so the government would save money. Maybe, but what are the health consequences?

Deane Beebe, a spokeswoman for the Medicare Rights Center, said: "The whole concept is based on the idea that people will use too much medication if they have coverage. We're really troubled by that."

Mr. Hayes added, "There is something very unrealistic about politicians who think that people will rush off to take prescription medication they don't need."

Hayes believes that the prohibition might be eliminated before 2006, partly because of pressure from insurance companies that want to sell the coverage. "A lot of people who voted for this bill," he said, "had no clue about this provision."

Dallas Morning News: public health comes first.

Thank God the Dallas Morning News has weighed in on the public-health issues facing Dallas County with an editorial that urges the County Commissioners to split the health department from the county's Department of Health and Human Services. The mid-90's merger of public health and welfare functions, says the editorial, was "to cut overhead costs. The budget concerns back then may have been justified. But they have been overtaken by today's more pressing challenges. For one, the county has had to step up its bioterrorism preparedness in this post-9-11 world. And that duty is certain to grow." More importantly:

many physicians have become concerned about the combined department's apparently poor record of controlling diseases. The Dallas County Medical Society cites the county's alarming rates of sexually transmitted diseases, its high incidence of tuberculosis and its low rate of childhood immunizations. A re-energized Health Department would be better able to identify public health problems early on and map out strategies for solving them.

The medical society -- under the leadership (on this issue, as on so many more) of past president Robert Haley -- also deserves our thanks for jaw-boning the county (and the editorial board of the Dallas Morning News, apparently) for adequate public health resources and controls.

2002 shows higher rate of health-care inflation than 2001.

Is anyone in the health care industry really surprised to learn that, "[f]ueled by rising hospital costs and health insurance premiums, U.S. employers, consumers and the government spent 9.3% more on health care in 2002 than they did in 2001"? (USA Today) Not surprised, perhaps, but that doesn't mean everyone took the news in stride. Forbes, for one, opined that "Health Care Costs Rise Beyond Belief":

U.S. health care costs are rising so fast that not only do they outstrip the prior year, they even exceed forecasters' ability to project them.

In mid-2002, the U.S. Department of Health and Human Services projected that national health expenditures would reach $2.8 trillion in 2011--an estimate based on a mean annual growth rate of 7.3%. Since then, the growth rate has increased significantly to 9.3%--to the point where health spending is already at nearly 15% of GDP, according to Centers for Medicare & Medicaid Services (CMS), a unit of HHS.

This increase--and future projections--don't take into account the potential effects of the prescription drug entitlement in the Medicaid bill passed by Congress last year.

The full report from CMS is available in Health Affairs (for a hefty fee; unhelpful article abstract is here); some of the details are on the CMS website here.

Clark: No pro-life appointments to the federal bench if he's elected.

According to a story in today's Manchester Union Leader Gen. Wesley Clark "said yesterday he would never appoint a pro-life judge to the federal bench because the judge’s anti-abortion views would render him unable to follow the established judicial precedent of the 1973 Roe v. Wade decision." I am pro-choice, but I wonder how wise it is to establish an abortion-rights litmus test, any more than a pro-life litmus test should be used by Republican presidents. First, we're not talking about Supreme Court appointments only: Clark's announcement included all federal courts. This ignores the fact that we expect lower-court judges to follow Supreme Court precedent, and their freedom to "vote their conscience" is correspondingly constrained. (This is why I was comfortable supporting the nomination of Mike McConnell, a vociferous critic of Roe, to the US Court of Appeals for the Tenth Circuit.) Second, what's sauce for the goose is sauce for the gander. A single issue litmus test on abortion is decried by liberals when the Republicans invoke it to eliminate pro-choice judicial candidates. Unless that's all bluff and bluster, we should be willing to stand behind that position when it cuts the other way. That, or just shut up when the Republicans exercise their constitutional right to stack the judicial deck against abortion rights.

For-profit Medicare HMOs match, exceed nonprofits' care.

As reported lots of places, including the Boston Herald, a report in today's New England Journal of Medicine (abstract only; full text requires expensive subscription): "The rates of carotid endarterectomy, cardiac catheterization, coronary-artery bypass grafting, and percutaneous transluminal coronary angioplasty were higher in for-profit health plans than they were in not-for-profit health plans; the rates of use of other common costly operative procedures were similar in the two types of plan. After adjustment for enrollee case mix and other characteristics of the plans, the for-profit plans had significantly higher rates than the not-for-profit plans for 2 of the 12 procedures we studied and had lower rates for none." This is definitely one of those glass-half-full or half-empty stories. The Herald story included some follow-up with the authors:

The results were unexpected, but not surprising, said Dr. Eric C. Schneider, a Harvard School of Public Health assistant professor.

"It's very difficult among health plans in general to change the decision-making of physicians and patients,'' he said. "And with liability concerns, health plans may feel that it would be too risky to deny a procedure.'' . . .

In some cases, nonprofits provided fewer procedures, but it's not clear why, Schneider said. It's possible that nonprofit administrators have a better sense of how to care for problems without relying on surgery.

The study clearly shows that "fears about for-profits skimping on high-cost procedures might be unfounded,'' Schneider said. But it doesn't show whether they provide the same level of care when it comes to preventive and other services.

I.M.F. Report Says U.S. Deficits Threaten World Economy

Two cheery reports from the NY Times and Washington Post today raise the question whether the US can continue in its fiscally and environmentally profligate ways.

First, an International Monetary Fund report concluded that the United States is running up a foreign debt of such record-breaking proportions that it threatens the financial stability of the global economy, warning that large budget deficits posed "significant risks" not just for the United States but for the rest of the world. Times article. IMF Occasional Paper 227: "U.S. Fiscal Policies and Priorities for Long-Run Sustainability." A small but important part of the planned deficit, of course, is the recently enacted Medicare prescription drug benefit that we cannot afford.

Second, the Post reports that researchers have published a study (abstract) in the science journal, Nature that concludes that "[m]any plant and animal species are unlikely to survive climate change. New analyses suggest that 15-37% of a sample of 1,103 land plants and animals would eventually become extinct as a result of climate changes expected by 2050." They continue:

For some of these species there will no longer be anywhere suitable to live. Others will be unable to reach places where the climate is suitable. A rapid shift to technologies that do not produce greenhouse gases, combined with carbon sequestration, could save 15-20% of species from extinction. The cover shows a species in the firing line. Boyd's forest dragon, Hypsilurus boydii, is found in Queensland, Australia. About 90% of its distribution would become climatically unsuitable by 2050, on maximum climate warming scenarios.

At some point, industrialized societies have to start getting serious about their ethical obligations to the planet's other inhabitants, as well as to the future. My colleague, Jeff Gaba, has amply demonstrated that arguments about "our obligations to future generations" are fraught with ambiguity, hidden assumptions, and various forms of bad logic, but the rhetorical point somehow seems to survive, at least for me: What gives industrialized nations the right to consume not only a disparate share of the world's natural resources to support their economies anlifestyleses, but also up to a third of the world's species (that's 1.25 million species), as well? This is a bioethics question of transcendent importance.

Maine's Prescription Drug Discount Program on Hold -- Again.

Apparently Maine's star-crossed drug discount program, which survived a Supreme Court challenge in 2003, is again on hold as state officials assess the impact of the recently enacted Medicare reform law. You can read about it in the daily Kaiser health policy report.

Ernst & Young faces civil health fraud charges in Philly.

Kaiser's daily web report collects stories today about the civil case filed on Monday against Ernst & Young in connection with advice it allegedly gave to hospitals that in turn overbilled Medicare:

U.S. Attorney's Office in Philadelphia Files Lawsuit Against Ernst & Young for Allegedly Providing Hospitals Advice That Led to Medicare Overpayments
[Jan 06, 2004]
U.S. Attorney Patrick Meehan in Philadelphia on Monday filed a civil complaint against the accounting firm Ernst & Young for allegedly advising hospitals to overcharge Medicare for common blood tests, leading to excess reimbursements of $900,000 between 1991 and 1995, the New York Times reports (Freudenheim, New York Times, 1/6). The lawsuit claims that because of billing advice given by Ernst & Young, nine hospitals in Connecticut, Indiana, Pennsylvania and Virginia submitted more than 200,000 false claims to the government. The suit contends that the nine hospitals' laboratories used equipment that automatically performed a more thorough level of testing than necessary in some cases, which allowed the hospitals to bill for the complete battery of tests, regardless of whether they were requested by physicians, to maximize Medicare reimbursements. According to Ernst & Young attorney Mark Tuohey, the government permitted such billing until 1996, at which time Ernst & Young advised its clients to stop the practice. If found guilty, Ernst & Young could be ordered to pay three times the amount of damages and millions of dollars in fines. Associate U.S. Attorney James Sheehan said some of the hospitals involved in the dispute have already repaid Medicare (Caruso, AP/Long Island Newsday, 1/5).

Fascinating.

Purdue Pharma spanked by judge for Oxycontin patent claim

As reported in USA Today and elsewhere, a federal judge ruled that Purdue Pharma patents protecting its bestselling painkiller Oxycontin are invalid. The court's opinion states that Purdue's patent application was deceptive and that its patents are unenforceable, clearing the way for drug maker Endo Pharmaceuticals Holdings to sell a generic version of the drug. This is the same judge who held in 2000 (require WestLaw subscription) that Purdue had not obtained its patents through inequitable conduct. It will be interesting to see (when yesterday's opinion becomes available) what changed between 2000 and 2004. Meanwhile, there's lots of interesting background in the N.Y. Times' story on this decision.

New Jersey allows stem cell use in research

New Jersey's governor signed a bill (S. 1909 [passed without amendment - now P.L.2003, c.203]) on Sunday that makes the Garden State the second in this country to legalize embryonic stem cell research, while making human reproductive cloning unlawful. (California's the other state: see Health & Safety Code § 125300 (stem cell research) and § 24185 (cloning).) It's a fine line, and one that bedeviled the President's Council on Bioethics in its 2002 report on cloning, but it's an important line for those who believe that stem cells are the most promising source out there of treatments for a wide variety of diseases and conditions, including traumatic spinal cord injuries.

Reimportation of drugs from Canada.

The Kaiser Family Foundation did its usual excellent job in an article today that pulls together reports from disparate sources concerning the FDA's refusal to accept Canadian assurances that reimported drugs are safe:

FDA Pharmacy Affairs Directory Tom McGinnis on Dec. 24, 2003, said that a safe, legal program to reimport lower-cost, U.S.-manufactured prescription drugs from Canada would likely cost hundreds of millions of dollars, the AP/Richmond Times-Dispatch reports. In addition, McGinnis said that the FDA would never rely on Canadian inspections of prescription drugs to determine their safety. McGinnis said that although the FDA inspects pharmaceutical companies worldwide, Health Canada relies on inspections conducted by the home nations of the companies. McGinnis said, "We've never accepted inspection results from another country." He added that a reimportation program is "just not going to work. There would have to be mechanisms set up, and we would have to get permission from the Canadian government to inspect." Health Canada spokesperson Emmanuel Chabot defended the safety of the Canadian inspection system. He said, "We conduct regulatory reviews of drugs to ensure there is sufficient evidence of safety, efficacy and quality before they receive authorization to be sold in Canada." According to the AP/Times-Dispatch, the FDA position on reimportation "sets the tone" for an HHS study on the safety of the practice required under the new Medicare law (Baldor, AP/Richmond Times-Dispatch, 12/25/03). In recent months, a number of state and local governments have asked the federal government to allow them to import prescription drugs from Canada, the Washington Times reports (Fagan, Washington Times, 1/2). More than 12 states -- such as Iowa, Illinois, Minnesota and New Hampshire -- have considered or plan to implement reimportation programs, USA Today reports. Kevin Concannon, director of the Iowa Department of Human Services, said that the statements FDA officials "make about consumer safety or drug safety are the most bogus words I've seen spoken from a government agency. ... There's more protection of pharmaceutical manufacturers than there is of patients" (Welch, USA Today, 12/31/03). However, HHS spokesperson Bill Pierce said that the agency has twice determined that "we could not guarantee the safety" of reimported prescription drugs, adding, "Nothing has changed since that time" (Washington Times, 1/2).

The birth of an idea: iatrogenesis

There's an excellent review in the Sunday N.Y. Times of Sherwin Nuland's "The Doctors' Plague," a history of Ignac Semmelweis' attempt to nail down the etiology of childbed fever. If Semmelweis isn't exactly a household name, it may have to do with the fact that Pasteur, Lister, and Koch would need another 10 years after Semmelweis' research to develop a unified germ theory of disease. Also: Semmelweis' genious as an epidemiologist seems to have been matched by his dismal indifference to bench science --

Semmelweis was a lopsided genius. His singular talent lay in sorting through reams of data and finding subtle patterns squirming beneath -- all the while ignoring the essence of the infection lying within his fingers' reach. In Semmelweis, an insightful epidemiologist seemed to have collided with a blind pathologist. And unfortunately, the more he struggled to make the two prongs of his scientific inquiry meet, the more desperate and unreasonable he seemed to become. His book on childbed fever, written at the end of his life, reads more like a manic manifesto than a treatise. Scientific history never seems to have forgiven him for it.

But what continues to fascinate is Semmelweis' insight -- perhaps a commonplace in this century, but heretical int he 19th -- that puerperile fever was the result of an infection that was passed on from doctor to patient because of a lack of basic sanitation as physicians moved from patient to patient. The review (by Siddartha Mukherjee) concludes:

To the post-Thalidomide generation of doctors -- to doctors inured to the fact that a medicine or procedure can itself be toxic -- Semmelweis's discovery may come as no surprise. But, as Nuland reveals in some of his most reflective paragraphs, for the high-minded physicians of Vienna and Budapest this was a deeply unsettling premise, for it struck directly at the self-image of their profession. Doctoring was supposed to be a do-good business. It wasn't supposed to make young mothers die of preventable illnesses. What Semmelweis had managed to expose was a hidden anxiety within medicine itself, doctors' ''horror at the possibility that they had been killing their patients for years.''

It is this anxiety that still haunts us. In 2003, 150 years after Semmelweis, some of the most disturbing pieces of medical news involved iatrogenic complications -- doctors' plagues, if you will. The first -- SARS -- was an infection that was spread through hospital wards, often carried by doctors, much like the infections that had vexed Semmelweis in the 1850's. The second -- the so-called million-women study, which revealed the toxic side effects of hormone replacement therapy -- marked a moment of deep introspection in women's health, making doctors question their cavalier willingness to push theories and medicines on patients long before the evidence on them had accumulated.

Like Semmelweis himself, Nuland's book is short, intense and single-minded, and these larger themes and implications are left teeming underneath the text, for readers to peer in closely and uncover. ''To receive his due of honor,'' Nuland writes, Semmelweis ''had to be rediscovered.'' ''The Doctors' Plague'' succeeds for exactly that reason: in telling the story of childbed fever, Nuland has managed to rediscover a critical moment in the history of medicine, the anxieties of which, although somewhat attenuated, persist today.

Pharmacy plan in Florida scuttled after one day.

According to the Orlando Sentinel (reported Jan. 3 (requires free registration; AP picked the story up today -- see, e.g., NY Times/AP story),

Amid an outcry from patients and pharmacists, the state of Florida on Friday abruptly pulled the plug on a new system that forces private pharmacists to decide whether to make poor and medically needy patients pay a fee for prescriptions that have been free.

Health advocates and state lawmakers blasted the system, started just two days ago, which they said is illegal and could force thousands of poverty-stricken people to pay fees they can't afford -- or, at worst, deny lifesaving drugs to critically ill patients.

"We've made pharmacists the gatekeepers," said state Rep. Anne Gannon, D-Delray Beach. "They're deciding whether people live or die."

Don't look now, but the same thing is happening in Dallas County's own Parkland Memorial Hospital, where patients who are too poor to afford prescription meds and too "rich" to qualify for Parkland's health plan are being sent home from the ER and from surgery without the drugs they need to stay alive. As the Dallas Morning News editorialized on Saturday, the County Commissioners have a couple of big votes lined up this week, one of them on Parkland's plan to add to its current main hospital/8 clinics. (The other vote concerns a successor to health commissioner Betty Culbreath. What the editorial didn't mention is that Dallas County is currently experiencing a public-health meltdown. We lead the state in any number of infectious diseases and we lack the infrastructure to have a clue -- let alone a plan -- about an outbreak of salmonella that affected more than 650 people in all 50 states until we were warned by the CDC that something fishy was going on in the Anatole's salsa kitchen (story).) Meanwhile, it seems like business as usual on the Commissioner's Court, where public health -- not to mention life-and-death policies affecting Parkland patients -- seems to be a low priority at best. Shame on the Court and (so far) on County Judge Margaret Keliher, whose campaign touted that electing her would be good for Parkland. We're watching . . . .

Medicare and Medicaid - the outlook to 2050

This just in from the AHLA's Health Law Highlights:

CBO Predicts Federal Healthcare Program Spending May Reach Unsustainable Levels Under Current Policies

Total federal spending for Medicare and Medicaid in 2050 could range from 6.4% to more than 21% of gross domestic product (GDP), the Congressional Budget Office (CBO) predicted in its recently released long term budget outlook. In 2003, the programs accounted for 3.9% of GDP. "Unless taxation reaches levels that are unprecedented in the United States, current spending policies will probably be financially unsustainable over the next 50 years," CBO said.

The report is here.

U.S. News: Science calls at the deathbed(1/12/04).

The January 12 issue of U.S. News and World Report has a compelling article about human research conducted on "the nearly dead." The article contrasts research on University of Pittsburgh patients who have already been declared dead according to neurological criteria ("brain dead") but not yet taken off the respirator and research on terminally ill patients at M.D. Anderson who are expected to die soon after life-support is removed. The risk-to-benefit ratio for a dead patient is, of course, extremely low (pretty close to 0/0). The same is almost true of patients as to whom the decision has been made to withdraw life-sustaining treatment and allow the patient to die, but the risk is not zero:

"You can harm living people in ways that you can't harm dead people," says [Pittsburgh ethics panel member Michael] Wicclair. For example, what if the doctors are wrong and the person doesn't die after withdrawal of the machines?

Rebecca Pentz, formerly at M.D. Anderson and now at Emory, is organizing a conference on the topic for Spring 2004. Should be a lively event.

Safire: From politics to books, my 2004 picks

William Safire's New Year's prediction column is always a hoot. This year's outing was no exception. Apart from his prediction of the Academy Award for "Best Picture" ("Mystic River" -- my youngest son concurs), note item 8:

8. The scientific advance of the year will be (a) age retardation enhanced by memory protection; (b) a single pill combining erectile dysfunction treatment with a fast-acting aphrodisiac; (c) neuroscientists' creation of a unified field theory of the brain; (d) the awakening of geneticists to the liberating study of bioethics.

Safire's answer? (d)