HealthLawProf Blog

Cheerleaders Boost Drug Sales to Docs

There are some stories that are so perfect in their own way, so self-contained and self-explanatory, that additional commentary can only detract from the tale.  This is one, from The NY Times:

Gimme an Rx! Cheerleaders Pep Up Drug Sales

This paragraph conveys the essence:

Known for their athleticism, postage-stamp skirts and persuasive enthusiasm, cheerleaders have many qualities the drug industry looks for in its sales force. Some keep their pompoms active, like Onya, a sculptured former college cheerleader. On Sundays she works the sidelines for the Washington Redskins. But weekdays find her urging gynecologists to prescribe a treatment for vaginal yeast infection.

And in today's Times comes this rejoinder (requires paid subscription), also perfect in its own way:

To the Editor:

Re "Gimme an Rx! Cheerleaders Pep Up Drug Sales" (front page, Nov. 28):

As a female emergency physician, I smiled - no, laughed outright - that this made your front page.

Any doctor who sees pharmaceutical representatives knows that there is an overabundance of very attractive young women calling on doctors' offices.

Certainly, their appeal is obvious, but they are not selling lip gloss to teenage girls; they are selling expensive, patented drugs to doctors who I hope would be persuaded to prescribe the drugs for their merits and safety, not by the appearance of the representative.

If it's any consolation to the people who were shocked by this marketing stratagem, I was never swayed to prescribe a drug by a Cleveland Browns cheerleader.

Andrea Rodgers, M.D.
Akron, Ohio, Nov. 28, 2005

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Wrongful Abortion: A Wrong in Search of a Remedy

Professor Ronen Perry and Adjunct Lecturer Yehuda Adar of the University of Haifa have published "Wrongful Abortion: A Wrong in Search of a Remedy," in 5 Yale J. Health Pol'y, L. & Ethics 507 (2005).  Here is an abstract of their article:

Wrongful abortion is an abortion that a pregnant woman is induced to undergo by a negligent conduct (usually a medical misrepresentation). For example, early in her pregnancy a woman is told by her physician that a medication that she had taken would cause her baby to be born with a severe birth defect. Based on the expert opinion, she decides to undergo an abortion. Only after the abortion does she learn that the advice regarding the baby's health was a negligent misrepresentation, and that the termination of the pregnancy was unnecessary.

Underlying our article is a fundamental intuition that the law does not currently provide adequate incentives to avoid wrongful abortions considering their obviously devastating consequences (one of which is the loss of potential human life), and an innovative understanding that the best solution to this problem may be built on the distinctive characteristics of the wrongful-abortion setting. Validating the basic intuition requires a systematic and comprehensive analysis of existing law, and justifying the innovative solution entails a thorough theoretical inquiry.

Accordingly, the article addresses two interrelated questions. First, how is existing law likely to respond to wrongful abortions? We ask how the law is likely to respond and not how it actually responds, because the problem of wrongful abortion has been the subject of judicial opinion only in very few sporadic cases, making it practically impossible to generate a comprehensive analysis of case law directly on this point.

Second, how should the law respond to wrongful abortions? As our analysis of positive law will reveal, wrongful abortions raise a unique problem to which current law does not provide an appropriate solution. Our objective will then be to discuss the various alternatives that policy makers may consider in response to this peculiar disparity.

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8th Circuit Strikes Down Missouri's Partial-Birth Abortion Law

From Jurist:

A three-judge panel of the US Eighth Circuit Court of Appeals Monday upheld [opinion text, PDF] a lower court decision striking down a Missouri law restricting late-term abortions. The Infant Protection Act [statute text] was passed in July 2004 and made it unlawful for any person to "cause the death of a living infant with the purpose to cause death by an overt act performed when the infant is partially born or born". The law restricted most abortions performed during and after the second trimester. The court agreed that the law posed a undue burden to a woman's constitutional right to abortion because the measure lacked an exception for procedures performed to save the health of the mother. AP has more.

The 8th Circuit's decision is only the latest in a string of such rulings -- some against state laws, others against the federal version -- over the past two years.  In every instance, the fatal flaw was the absence of an exception to protect the health of the mother.  As for the federal statute, three district courts and two courts of appeal have agreed that the law is unconstitutional.  At this rate, without a split among the circuits, the issue will get to the Supreme Court only if the Court concludes that "a United States court of appeals has decided an important question of federal law that has not been, but should be, settled by this Court" [SCOTUS Rule 10(c)]. 

Considering the small number of late-term abortions performed each year, one could make an argument that this is not a terribly important question of federal law.  On the other hand, 20 states have no such law, and an increasing number appear to have a version that is unconstitutional, so the validity of the federal law is of no small consequence and that consequence is growing. 

But the real point is that partial-birth abortion bans have great symbolic importance to both sides of the abortion debate.  The question, which I pose on the day before oral arguments in the first abortion case to be taken up by SCOTUS in at least a couple of years, is this: How eager is the Court to be drawn back into this highly emotional issue?  We will find out this year. [tm]

"Medicaid, Elective Shares, and the Ghosts of Tenures Past"

Prof. Julia Belian has published "Medicaid, Elective Shares, and the Ghosts of Tenures Past," in 38 Creighton L. Rev. 1111-1152 (2005) (full text here).  Here is the abstract of her article:

Legislators and administrators understandably struggle to ensure that Medicaid benefits are paid only to those who meet the criteria for financial need. Thus, Medicaid benefits will be denied to those who have "available" any "resources" above a certain small reserve. The definition of "available resources" and the application of that definition, however, have finally expanded so far that certain traditional property law concepts seem to disappear. Court opinions not only routinely uphold these regulations but go on to excoriate such estate planning techniques in harshest terms, even in cases where Medicaid qualification clearly was not the goal. Meanwhile, many citizens who engage in overt Medicaid planning are the same citizens who would never lie on their tax returns, hide assets from their spouses, or make false statements in order to qualify for housing or food assistance. This article explores these phenomena in light of the common law's evolving conceptions of "property", particularly as these are reflected in the history of the elective share and its ancestor, dower. The pressures created by unimagined high costs of such care may have called forth something very ancient - the sense that "property" may not be a thing at all, and that "property rights" may not be natural rights that we possess as individuals in some pre-social context, but that both point instead to a complex system of mutual and reciprocal obligations that develops as the State and its citizens struggle to allocate scarce resources among them.

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Human Research and Indigent Minorities

Prof. Ruqaiijah Yearby has posted a working draft of her book review, "Ending the Exploitation of the Vulnerable: The Promise of the Intersection of American Bioethics, Human Rights, and Health Law," on the SSRN Working Papers site.  Here is the abstract:

Traditionally, American bioethics has served as a safety net for the rich and powerful, for they are not forced to act as research subjects to obtain access to general health care for themselves or their children. However, American bioethics has failed to protect the vulnerable, i.e. indigent minorities. The vulnerable are not treated the same as the rich. They do not have access to health care. They are exploited in clinical trials that promise monetary gain or access to health care and their autonomy rights are often ignored. Some of the vulnerable most affected by these disparities are African-Americans. African-Americans have less access to care, less physician visits and hospitalization, than whites even though the evidence shows that serious illness is much more common among blacks than whites. Furthermore, African-Americans continue to be targeted to participate in dangerous clinical trials, with limited direct benefits, with the promise of monetary gain or access to health care. Finally, the autonomy rights of Africans-Americans to consent to all means of treatment or tests are often ignored.

Instead of serving as a means to promote justice and end these racial disparities in accessing health care or participation in dangerous research studies, American bioethics has tended to focus its attention on ethical issues associated with scientific and medical advances without recognizing that these developments occur in a social context that must be taken into account if the ethical issues are to be adequately addressed. American bioethics fails to take into consideration the social and economic conditions, such as poverty and de facto discrimination through disparate impact that influence research subjects' decisions to participate in dangerous research studies, with diminutive direct benefit, to obtain access to health care and monetary support. The continuation of these racial disparities in access to care and exploitation of minority populations for dangerous clinical trials after the creation of American bioethics can no longer be ignored.

American bioethics is replete with instances of de facto discrimination through disparate impact that pervert the physician-patient and research-subject relationships, such as the necessary informed consent for participation in clinical trials or drug testing. Without reflecting and rectifying the de facto discrimination through disparate impact that continues to allow the vulnerable to be exploited for the benefit of society under American bioethics principles, the same exploitation will continue with the inclusion of human rights. Now physicians, researchers, and government agencies that have ignored or misused the principles of bioethics, will only need to ignore or manipulate another set of rules in order to obtain the outcomes they desire: limit access to health care and the exploitation of the vulnerable for the benefit of science. In fact, the inclusion of human rights will serve to legitimize their violations both in America and abroad. The addition of health law does not solve this problem because courts rarely acknowledge or punish perpetrators for their de facto discrimination through disparate impact.

Courts reviewing issues concerning health law do not acknowledge or address the presence of de facto discrimination in their decisions even when it is clear that race was significant factor. Moreover, the enforcement of Title VI, which prohibits racial discrimination in health care, is illusionary at best. To date, the federal government has never filed a federal case under Title VI to protect minorities from racial discrimination in health care. Therefore, African-Americans' bear the burden of filing cases, which have included claims concerning the lack of access to health care. Usually these cases are based on a theory of discrimination as a result of disparate impact of neural policies. Recently, the Supreme Court barred private parties from bringing Title VI case based on a theory of discrimination through disparate impact. Thus, the inclusion of law, or more specifically health law, does not afford African-Americans much protection against the effects of discrimination.

To end the exploitation of the vulnerable through the intersection of American bioethics, human rights, and health law, American bioethicists must admit that race matters, as the underlying cause for inequalities in health care present in governmental access to health care, research studies, and one-on-one doctor-patient relationships. American bioethicists must end the exploitation of the vulnerable through the eradication of de facto discrimination. The government must impose and enforce meaningful sanctions to address the lack of access to care, to prevent continued exploitation, and to prohibit the violation of the autonomy rights of the vulnerable based on discrimination. Moreover, bioethicists must defame any government, researcher, or physician that fail to comply with these standards. This book review will focus on the means by which to end the exploitation of the vulnerable.

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Health Reform: Two Views from Health Affairs

Continuing its role as one of a handful of "must-read" publications in the health care field, Health Affairs' November/December issue is filled with valuable articles on health reform.  Here's a sampling:

• Health Care Reform: Why? What? When?
  Victor R. Fuchs and Ezekiel J. Emanuel
  Dissatisfaction with the U.S. health care system is widespread, but no consensus has emerged as to how to reform it. The principal methods of finance—employer-based insurance, means-tested insurance, and Medicare—are deeply and irreparably flawed. Policymakers confront two fundamental questions: Should reform be incremental or comprehensive? And should priority be given to reforming the financing system or to improving organization and delivery? We consider here several proposals for incremental reform and three for comprehensive reform: individual mandates with subsidies, single payer, and universal vouchers. Over the long term, reform is likely to come in response to a major war, depression, or large-scale civil unrest.
• Whence And Whither Health Insurance? A Revisionist History
  Donald W. Moran
  Throughout the postwar era in federal health policy, policymakers have sought to expand both public and private insurance coverage, while wrestling with the cost consequences of the demand generated by the insurance-financing mechanisms thus created. This essay advances the view that the limits to insurance expansion have been reached and that public and private plan sponsors will henceforth continually "thin out" the coverage they offer. In this environment, policymakers seeking to mitigate access concerns may need to consider strategies that promote direct service delivery. This emerging regime, it is argued, will have important implications for the future of innovation in health care.
• The Political Divide In Health Care: A Liberal Perspective
  Thomas Bodenheimer
  U.S. health policy has been consumed by an ideological divide between conservative and liberal viewpoints. The liberal philosophy, based on both moral principles and utilitarian arguments, attempts to balance the needs of the individual with the concerns of the entire population. Elements of the liberal health care perspective include a belief that health care is an equal right of all people, the implementation of that right through a social insurance system that provides universal health coverage, equitable financing of health care, and a commitment to equality in health care.

There are a lot of other articles in this issue, especially on consumer-driven market competition, that are well worth reading.  [tm]

The Transformation of Competition in Health Care

There will be a one-day conference this Friday in Washington entitled, "The Transformation of Competition in Health Care."  The conference is co-sponsored by the Center for Studying Health Care System Change, Health Affairs, and Kaiser Permanente Institute for Health Policy, and details are available here. 

The HSC website offers this description:

Health care market competition is changing. Under the old paradigm, employers and insurers acted as consumers’ agents in the market, organizing and defining their choices. More and more, consumers are expected to act as their own agents. Are we witnessing a fundamental shift in responsibilities in health care markets, and what are the implications for health care quality and value?

Although conference participants aren't identified on these websites, I would expect them to include at least some of the contributors to Health Affairs' discussion of "Consumerism" in its current issue.

An archived webcast of the event will be available after 3pm EST on December 6. [tm]

Wennberg on Practice Variations in California

Here's a Web Exclusive from Health Affairs:

John E. Wennberg of the Dartmouth Center for Evaluative Clinical Sciences, finds that Medicare spent far more in the last two years of life for enrollees treated in Los Angeles hospitals than it did in Sacramento hospitals, indicating the presence of vast variations in how providers in the two metropolitan areas treat patients. Wennberg and colleagues examined claims data for chronically ill Medicare beneficiaries in California who died during 1999-2003, to develop a picture of health care resource utilization patterns in California hospitals. LA hospitals on average received 69 percent more per Medicare patient treated in the last two years of life than did Sacramento hospitals, which the authors used as the state's benchmark for spending. Medicare could have saved $1.7 billion had the per person spending been the same in LA as in Sacramento over the study period.

Accompanying Wennberg's paper are perspectives by Sen. Max Baucus (D-MT); Thomas Priselac, president and chief executive officer of Cedars-Sinai Health System in Los Angeles; Uwe Reinhardt, James Madison Professor of Political Economy at Princeton University; Leonard Schaeffer, chairman of WellPoint, and Dana McMurtry, WellPoint's vice president for public policy; and Barry Straube, acting director of the Office of Clinical Standards and Quality and acting chief medical officer of the Centers for Medicare and Medicaid Services (CMS).

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Korean Stem Cell Pioneer Admits Ethical Lapse

In a stunning news conference on Thursday, Korean stem cell researcher, Dr. Hwang Woo Suk, admitted violations of international ethics standards.  Dr. Hwang "won world acclaim as the first scientist to clone a human embryo and extract stem cells from it," according to the New York Times.  Hwang admitted that some of the eggs used in his research came from junior researchers and others came from paid donors.  According to the Times:

Although the egg donations by the junior researchers were not considered a legal or ethical violation, critics say that in the strict hierarchy of a scientific laboratory in a Confucian society like South Korea, junior members often feel great pressure to please their superiors. Under international medical ethics standards, researchers are warned against receiving eggs from members of their own research teams who are deemed to be in a dependent relationship.

Payment for eggs was not illegal in 2003, but it was banned last January by South Korean law.

Hwang also resigned his position as director of the recently created World Stem Cell Hub.  On Saturday the AP reported that South Korea pledged to continue its support for Hwang's research activities.

Hwang's admission came 11 days after Dr. Gerald Schatten of the University of Pittsburgh was reported by the Korea Times to have pulled out of a partnership with Dr. Hwang "because he might be engaged in ethical breaches and lie about them."  The NY Times story states that Hwang's "world reputation is now expected to suffer a major dent over his admissions that he lied to an international scientific journal over eggs obtained in what many see as an ethically murky manner." [tm]

Bird Flu News Roundup

The public health consensus seems to be that avian flu bears watching, but it's easy to overstate the significance of the disease over the short term.  Here are the latest stories from the AP/MyWay news feed:

• Vietnam Stages Mock Bird Flu Drill   
  HANOI, Vietnam (AP) - The mock scenario was deadly serious: a Vietnamese laboratory had confirmed the bird flu virus had mutated and was spreading from person to person. Wailing ambulances carried a team of doctors to the affected Hanoi neighborhood. Clad from head to toe in green biohazard suits,...
• Taiwan Plans on Tamiflu to Treat Bird Flu
  JAKARTA, Indonesia (AP) - Indonesia reported a new human bird flu infection on Saturday, and Taiwan joined other Asian governments in announcing it wanted to produce the anti-viral drug Tamiflu to treat people infected with the virus. Tamiflu, otherwise known as Oseltamivir, has shown promise in...
• Turkey in Romania Tests Positive for Flu 
  BUCHAREST, Romania (AP) - A turkey has tested positive for the H5 subtype of bird flu in eastern Romania, officials said Saturday. The turkey came from a small farm in the village of Scarlatesti, Agriculture Minister Gheorghe Flutur said. Authorities will begin culling all domestic birds in the...

And in earlier news:

• China Reports New Bird Flu Outbreak
• Outbreak of Bird Flu Detected in Indonesia

And on Saturday the Wall Street Journal reported (paid subscription required):

Roche Says Three Asian Nations Are Free to Manufacture Tamiflu

Roche Holding AG, maker of the flu treatment Tamiflu, said it has told the governments of Thailand, the Philippines and Indonesia that they are free to manufacture the medication without paying compensation to Roche because the drug isn't patent-protected in the three countries.

Roche also has offered to discuss the "technical aspects of the manufacturing of Tamiflu with these countries in view of our expertise and experience in the manufacturing of this important medicine," a spokeswoman for the Swiss company said Friday.

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Due Process, Judicial Review, and HHS

Prof. Ruqaiijah Yearby has published "A Right to no Meaningful Review Under the Due Process Clause: The Aftermath of Judicial Deference to the Federal Administrative Agencies," in volume 16 of Health Matrix.  Here is the abstract of her article:

The Due Process Clause of the Fifth Amendment has been perverted in the federal administrative system. For example, federal agencies, such as the U.S. Department of Health and Human Services (HHS), regularly deprive individuals of liberty and property with little to no review. In its regulation of the health care industry through the Medicare program, HHS often turns a blind eye to procedural Due Process protections, such as providing individuals an opportunity to challenge the deprivation of property at a hearing, even though the Constitution, the Administrative Procedure Act, and the Medicare Act grant these protections. The Medicare compliance hearing process of nursing homes presents an excellent opportunity to study the procedural Due Process rights granted individuals challenging the actions of Federal Administrative Agencies. In Medicare compliance hearings, nursing homes are not afforded an opportunity to be heard in most instances; for the nursing homes are denied a hearing or when granted a hearing, the process is so limited as to be meaningless.

These issues are particularly compelling now because the federal government and insurance industry are using the findings of nursing home compliance hearings as the basis for fraud and abuse actions and for determining if a nursing home will receive liability insurance. Consequently, the amount of process provided during compliance hearings is even more essential to protect Due Process. Furthermore, although the Supreme Court seemingly granted nursing homes procedural Due Process rights in Shalala v. Illinois Council on Long Term Care, Inc., the reality is that nursing homes have negligible procedural Due Process rights. Moreover, what the Supreme Court deemed as sufficient process in 2000 is no longer what HHS provides under the Medicare regulations, thus calling into question whether the process given nursing homes is Constitutional.

The full article is available from the author. [tm]

Kidney Swap Bonds Families

Heartwarming Thanksgiving Story #234 (in the Organ Donation Division):

Two men need kidneys.  In each case, their spouses aren't a good match, but each spouse matches the other's husband.  Solution: kidney swap.  The only glitch that occurred was an inadvertent violation of the transplant center's rule that the donor families shouldn't meet beforehand, in case one or the other (or the other or the other) doesn't click and backs out at the last minute. Due to a scheduling error, however, all four got on the hospital's elevator, each with his or her overnight bag, at 6 a.m. the morning of the operations (4 of them).  They quickly deduced why they were all there. The couples have become fast friends, going out to dinner twice a month and spending Thanksgiving together this year.

The AP story is here. [tm]

HMO Liable for Nursing Home's Negligence

From Mealey's Health Care Legal News:

A California appeals court on Oct. 25 held that a health maintenance organization that contracts out its health care responsibilities to various providers, including nursing homes, is liable when one of those providers denies medically necessary services or commits malpractice in the delivery of those services (Teri Pagarigan, et al. v. Aetna U.S. Healthcare of California Inc., et al., No. B167722, Calif. App., 2nd Dist., Div. 7).  [Lexis/Nexis link to opinion] 

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Religion, International Human Rights, and Women's Health

David E. Guinn has posted a working paper entitled "Religion, International Human Rights, and Women's Health: Synthesizing Principles and Politics" [SSRN Working Papers Series].  Here is the abstract:

For many people at the turn of the millennium, human rights have become the new language of faith resonate with great meaning and profound value. However, like all traditional religions, human rights embody great complexity. Neither coherent nor consistent, human rights cannot overcome the fallibility of its human creators. When we attempt to use rights as absolute values - Dworkin's trump cards against infringement - we find ourselves confronting the contradictions inherent in equally valued rights when they come in conflict.

As noted by many authors, nowhere is this conflict more pronounced than the conflict between women's rights and the rights of freedom of conscience/religion present in many international human rights instruments. Lest this be thought a problem of Western privilege, where women can afford the luxury of seeking political parity with men, in this paper I will confront human rights conflicts that have a direct impact on women's health. This will include both reproductive health concerns and female circumcision/female genital mutilation.

In attempting to address these conflicts, I will begin by analyzing the nature of human rights to health and the particular rights of women to health - with the problems created by their separation from non-gendered rights. Next, I will begin my principled argument by arguing against both an absolutist understanding of rights, and a "strict equality" standard of interpretation that seeks to recognize a hierarchy of rights. Such an approach fails as a matter of law, as a matter of philosophy (under the foundationalist challenge), and in the face of history. Instead, I argue that while a principled interpretation of rights can provide some guidance, its utility is limited. Instead, it is imperative to consider rights within their political context. Human rights do not stand outside politics, but instead reflect aspects of that politics. Ultimately, the goal of any rights analysis is not to determine which rights take precedence, but how to find a synthesis respectful of each.

The full paper can be downloaded through a link at the address above. [tm]

Cartoon Roundup

The avian flu, sometimes with a Thanksgiving theme, proved irresistable again this week:

• Glenn McCoy, Universal Syndicate
• Dana Summers, Orlando Sentinel

Medicare Part D was also a popular target this week:

• Steve Sack, Minneapolis Star Tribune
• Ben Sargent, Austin American-Statesman
• Stuart Carlson, Milwaukee Journal Sentinel
• Drew Sheneman, Newark Star-Ledger
• Tony Auth, Philadelphia Inquirer

Plan B & the FDA:

• Ann Telnaes, CWS/NYTS

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TelaDoc: Is It Unlawful?

Last September we wrote here about TelaDoc.  Here's some follow-up from the LA Times (abstract only), summarized by the CDC's Public Health Law News service:

A controversial service is providing over-the-phone medical care to patients across the country, and while it is filling a need, some states say TelaDoc Medical Services is violating the law. The Dallas-based company began providing non-emergency medical care, including prescriptions, earlier this year, and has so far treated 40,000 patients. Patients must be more than 12 years old, subscribe to the service through a monthly membership fee, and pay a $35 fee for each call. After the patient sends an online message to the company, a licensed doctor calls the patient back within three hours. In states where regulations require doctors to diagnose patients in person, a technician visits the patient, takes vital statistics, and conducts a videotaped interview to send to the doctor. TelaDoc is popular with people who do not have the time or the money to see a doctor in person. But groups like the American Academy of Family Physicians and the American Medical Association oppose the service and worry that a patient could be seriously harmed. “They don’t examine the patient,” said Dr. David Goldstein, co-director of the University of Southern California’s Pacific Center for Health Policy and Ethics, “What about the clinical benefit of looking at someone’s skin or their eyes or listening to their heart?” The Medical Board of California says TelaDoc may be violating state law requiring that physicians conduct “a good faith prior examination” before prescribing drugs. But the company says it is not violating the law. “This is no different than doctors who’ve treated people over the telephone for years,” said TelaDoc’s general counsel Rocky Dhir.

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Mandatory Health Insurance in the Bay State?

From Wednesday's CDC's Public Health Law News:

Massachusetts may soon require health insurance for the state’s estimated half million uninsured residents. The state legislature is considering two separate plans. Under Gov. Mitt Romney’s plan, all residents would be required to buy insurance. Health insurance companies would be required to offer low-cost options, and people who earn less than $28,710 could receive state subsidies. The second plan, proposed in the House, would require employers to provide insurance or face a payroll tax. All persons who remained uninsured would face suspension of their driver’s licenses. The Massachusetts proposals are the first time any U.S. state legislature has seriously considered mandatory health insurance. “We have entered an age when there is more of a sense that there should be individual responsibility for your life and your family, that you owe it to your community to have coverage,” said Robert Blendon, a research professor at the Harvard School of Public Health. But not all residents are pleased with the prospect of being required to pay for health insurance. “Insurance is not my top priority right now. Day-to-day living is, like food,” said a Boston hair stylist. Other states have been hesitant to mandate insurance. “The fear with individual mandates is that you drive people out of state. Essentially it’s a tax, no matter how it gets worked out,” said Howard Berliner, of the New School for Management and Urban Policy in New York. But, said Berliner, “the individual mandate is not perfect, but I would much prefer in New York that we had that than just a growing number without insurance at all.” The Massachusetts bills are being considered by a legislative committee this week.

Read all about it in the Christian Science Monitor.  [tm]

Happy Thanksgiving to All

Today will be a day of food, family, and football for most of us, though not necessarily in that order.  Your editors at HealthLawProf Blog extend our wishes for a happy and safe Thanksgiving holiday.  If the Cowboys' game gets boring, I may be back at the computer for a while, but otherwise, expect a slow few days at the Dallas office of the Blog.  [tm]

More Unkind Words for Medicare Part D

From the Washington Post's Robert Samuelson ("Drug Benefit Disaster"): 

Good policy can make for good politics, and bad policy can make for bad politics. Republicans may be about to discover this truism with their Medicare drug benefit, passed by Congress in 2003 and scheduled to take effect in January. As policy, the drug benefit is a calamity. It worsens one of the nation's major problems (paying baby boomers' retirement costs) while addressing a nonexistent "crisis" (allegedly oppressive drug costs for retirees). Its purpose was mostly political: to bribe the elderly or soon-to-be-elderly to vote for Republicans in 2004. Now it may backfire on Republicans.

Samuelson's bill of particulars is familiar to many of us, but he neatly summarizes the problems: (i) unnecessary complexity, (ii) conservative outrage over the biggest expansion of the Medicare program since 1965, and (iii) the blatant political calculation that produced a plan that will produce higher out-of-pocket expenditures for many seniors (courtesy of the infamous doughnut hole) and that is still so bleeping expensive that the costs of the program will be covered by future taxes and borrowing.  [tm]

Hospitals' Uncompensated Care Rises Slightly

From Modern Healthcare's Daily Dose (requires free registration):

Hospital costs for patients who did not pay or could not afford to pay hit $26.9 billion in 2004, an 8% increase from 2003, the American Hospital Association said. The cost of patients' unpaid bills accounted for 5.6% of hospitals' total expenses last year. That's a slight increase from 5.5% in 2003, but still one of the lowest percentages reported since 1984. The association calculated uncompensated-care costs -- rather than charges -- based on hospital responses to its 2004 survey and using a formula that did not include discounts for Medicaid, Medicare or private insurers. The AHA said 85% of U.S. hospitals responded.

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CDC's 10-Year Research Agenda

Public health scholars trying to synchronize their research activities to keep pace with the "next new thing" might want to take a look at the CDC's "Public Health Protection Research Guide 2006 – 2015."  The 60-day formal comment period on the agency's research agenda began November 18.  More information is here.  The research guide is available here (free registration required).  [tm]

CDC: Better Quarantine Rules Needed

The AP reports that the CDC today proposed amendments to quarantine regulations, "hoping changes such as easier access to airline passenger lists could better protect Americans from foreign infectious diseases, including bird flu."

CDC's Pandemic Influenza Page
Notice of Proposed Rulemaking

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Krugman on Health Care

Four of Paul Krugman's recent op-eds in the New York Times have looked at health care economics and policy.  Because of recent changes on the Times' web site, these have been moved to the Times Select section, meaning (i) they require a paid subscription and (ii) the usual RSS feed for Times articles isn't available.  Oh, and they aren't available for free any more on the "unofficial Paul Krugman web site," either.  Well, you're just going to have to pay to see these, or pull them off Lexis-Nexis (to make that easier to do, I have added the Lexis-Nexis link for each of these):

• November 18, 2005: A Private Obsession [Lexis-Nexis]
  The Medicare drug benefit is an example of gratuitous privatization on a grand scale.
• November 14, 2005:  Health Economics 101 [Lexis-Nexis]
  Our patchwork, semiprivate system of health insurance is failing because insurance companies spend too much time screening applicants.
• November 11, 2005:  The Deadly Doughnut [Lexis-Nexis]
  Politicians who don' t believe in a positive role for government shouldn' t be allowed to design new government programs.
• November 7, 2005:  Pride, Prejudice, Insurance [Lexis-Nexis]
  National health insurance is the obvious solution for health care reform in America.

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Oral Argument Transcript in Gonzales v. Oregon

I'm a little late getting this link posted, but better late than . . .

Here's the 60-page transcript of the oral argument in Gonzales v. Oregon in the Supreme Court (question: whether Oregon's Death With Dignity Act is trumped by the Attorney General's interpretation of the Controlled Substances Act; the Ninth Circuit said no). [tm]

Genetic Screening Gets Serious

Today's NY Times has a piece by Amy Harmon about prenatal genetic screening and the social revolution that many see around the corner.  The article seems to have been spurred on by a report (abstract) in the Nov. 10 New England Journal of Medicine on first- and second-trimester screening for Down's Syndrome.  Here are some of the observations from the article:

• The new prenatal test provides earlier, more reliable results for all women than the current test, which is routinely offered to only older women who are at higher risk. But for people with Down syndrome and the cluster of other conditions subject to prenatal screening, the new test comes with a certain chill. Because such tests often lead to abortions, people with conditions from mental disability to cystic fibrosis may find their numbers dwindling. As a result, some fear, their lives may become harder just as they are winning the fight for greater inclusion.
• Some bioethicists envision a dystopia where parents who choose to forgo genetic testing are shunned, or their children are denied insurance. Parents and people with disabilities fear they may simply be more lonely. And less money may be devoted to cures and education.
• The co-director of the disabilities studies program at Pennsylvania State University, Michael Bérubé, whose 14-year-old son has Down syndrome, worries that if fewer children are born with the condition, hard-won advances like including them in mainstream schools may lose support. "The more people who think the condition is grounds for termination of a pregnancy, the more likely it will be that you'll wind up with a society that doesn't welcome those people once they're here," he said. "It turns into a vicious cycle."

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New Standards for Health Care Interpreters

If you do ethics (or other) consults in a multi-ethnic, multilingual environment, you know how crucial it is to have a great translator.  But what makes a health care translator great?  Here's an answer, courtesy of the Commonwealth Fund:

Summary
The National Council on Interpreting in Health Care (NCIHC) has developed the first set of national standards for medical interpreting professionals in the United States. The 32 standards provide guidance on the qualifications and proper role of the interpreter and define what constitutes good practice. They are designed to promote better communication between patients and health professionals who do not share a language and improve the quality of care for these patients.

The Issue: Although in recent years, health care facilities and agencies across the United States have made strides in providing linguistically appropriate services, there has been little clarity about what constitutes appropriate training, qualifications, and performance for bilingual health care interpreters, who facilitate communication between patients and providers. As a result, health care interpreting across the country is uneven and inconsistent, leaving many patients with limited English proficiency at risk of having incomplete and inaccurate communication with their health care professionals, which studies suggest can result in higher costs and poorer outcomes.

In 2004, the NCIHC published the National Code of Ethics for Interpreters in Health Care. Building on that code of ethics, these standards of practice define the characteristics and competencies of medical interpreters. They also describe what is considered "best practice" by the profession, helping to ensure consistency and quality across medical settings.

Organization: The NCIHC Standards, Training and Certification committee, with funding from The Commonwealth Fund and The California Endowment

Target Populations: Health care interpreters and those who train, employ, and work with interpreters

The Intervention: After commissioning an international environmental scan of current practices and existing published standards, the NCIHC Standards, Training, and Certification committee conducted a series of seven targeted focus groups across the country. Once they analyzed the focus group and environmental scan results, the committee drafted an initial standards document. The draft standards were presented to the health care community for feedback through a national survey of interpreters and those who work with them. The final document incorporates changes made by the committee after careful consideration of all the input from survey respondents.

The 32 standards—which are grouped into nine categories that are each associated with a corresponding ethical principle—are expected to be used in training, hiring, performance monitoring, and as a basis for discussion on the merits of a certification process to assess the qualifications of interpreters working or preparing to work in health care settings.

The new national standards provide guidelines on the following nine issues:

• Accuracy: To enable other parties to know precisely what each speaker has said.
• Confidentiality: To honor the private and personal nature of the health care interaction and maintain trust among all parties.
• Impartiality: To eliminate the effect of interpreter bias or preference.
• Respect: To acknowledge the inherent dignity of all parties in the interpreted encounter.
• Cultural Awareness: To facilitate communication across cultural differences.
• Role Boundaries: To clarify the scope and limits of the interpreting role, in order to avoid conflicts of interest.
• Professionalism: To uphold the public's trust in the interpreting profession.
• Professional Development: To attain the highest possible level of competence and service.
• Advocacy: To prevent harm to parties whom the interpreter serves.

For Further Information: To download a complete copy of the National Standards of Practice document, visit the NCIHC Web site. Also read NCIHC's press release.

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The Cost of Nosocomial Infections in PA

Modern Healthcare's Daily Digest (requires free registration) reported Thursday that a new report set the extra health care costs of nosocomial infections in Pennsylvania hospitals at nearly $2 billion in 2004:

Infections acquired in Pennsylvania hospitals resulted in extra charges of about $1 billion to Medicare, $370 million to Medicaid and $600 million to commercial insurers in 2004, according to the Pennsylvania Health Care Cost Containment Council. The Hospital & Healthsystem Association of Pennsylvania criticized the state's methodology and conclusions, saying reimbursement equals only a fraction of charges, and denied that hospitals were underreporting infections. Council Executive Director Marc Volavka challenged individual hospitals to release specific infection data and corresponding charges and collections. The state counted about 11,700 nosocomial infections -- pneumonia, surgical site, urinary tract or bloodstream -- at 173 acute-care hospitals, a rate of about 7.5 hospital-acquired infections per 1,000 admissions. Mortality was about 16% among Medicare and Medicaid patients with nosocomial infections but was 3.7% and 1.1%, respectively, among other Medicare and Medicaid patients.

According to its website, "the Pennsylvania Health Care Cost Containment Council is an independent state agency responsible for addressing the problem of escalating health costs, ensuring the quality of health care, and increasing access for all citizens regardless of ability to pay."

In a related story, Utne magazine reports in today's issue that hospital-acquired infections kill more people than breast cancer or car accidents, and its rate in patients has shot up 36 percent since 1975. [tm]

OIG Releases FY 2006 Work Plan

From Lew Lefko at Haynes and Boone, this important news: OIG has posted the Fiscal Year 2006 Work Plan. To access the new Work Plan go here.  [tm]

Harvard Center Announces Fellowship Openings

We've received the following fellowship announcement from Alex Boni-Saenz, a law student at Harvard:

The Petrie-Flom Center - Fellowship Program
The Petrie-Flom Center Announces its 2006-2007 Fellowship Program for post-graduate and mid-career fellows.

To ensure rich intellectual exchange and encourage the movement of top current and future scholars into issues of health care law and policy, the Center will sponsor research fellows at all stages of their academic and professional careers, from law and graduate students to scholars and practitioners who are experts in their fields.

Post-Graduate and Mid-Career Fellows
Petrie-Flom post-graduate fellows will be selected from among recent graduates and mid-career academics and practitioners who are committed to spending up to two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy. The first group of up to five post-graduate fellows will start in September 2006, followed by a second group in September 2007.

Program: The Petrie-Flom Post-Graduate fellowships are full-time, residential fellowships for two full years starting in September 2006. Fellows will devote their full time to research activities in furtherance of their own research proposals. No teaching obligations are associated with this fellowship, although teaching opportunities might be available to interested fellows with the Center's permission. Fellows will be expected to attend and participate in research workshops on health law policy and other similar events designated by the Center, and to present their research at least once per year in one of a variety of forums, including academic seminars, speakers panels or conferences. They also will be expected to provide opportunities for interested students to consult with them about their areas of research.

Salary and Benefits: Fellows will enjoy access to the full range of resources offered by Harvard University. Fellows will be provided with office space, library privileges, appointment fees, health benefits, a research budget, and a salary of up to $60,000 per full year.

Eligibility: Applicants must hold a degree in law or some other graduate discipline that they intend to apply to issues of health law policy and bioethics. The Center particularly encourages applications by those who intend to pursue careers as law professors, but will consider any applicant who demonstrates an interest and ability to produce outstanding scholarship in the areas of health policy, biotechnology or bioethics during the term of the fellowship. Applicants will be evaluated by the quality and probable significance of their research proposals, and by their record of academic and professional achievement.

Application: If you plan to apply for a fellowship starting in September 2006, please submit an Application Cover Sheet and download a copy of the Call for Applications (PDF) that contains additional information about the application process.

The website for the Center is: http://www.law.harvard.edu/programs/petrie-flom/ and the website for the fellowship program is http://www.law.harvard.edu/programs/petrie-flom/fellowship.php.  [tm]

Global Cervical Cancer Prevention

The New England Journal of Medicine has published an article about the ongoing effort to prevent cervical cancer:

The Promise of Global Cervical Cancer Prevention

NEJM, Volume 353:2101-2104		November 17, 2005		Number 20

JT

Non-profit Hospital Financials

Here is an interesting article on the increased financial information that is being shared by NFP hospitals.

Wisconsin AG to file complaints

The Milwaukee Journal Sentinel is reporting that the Wisconsin AG will file complaints against hospitals for charging uninsured patients more than they charge managed care companies for the same service.  If you have followed the Scruggs cases, most federal complaints have been dismissed but the state law complaints have created some issues for hospitals.

Here's a link to the story: Wisconsin AG

JT

Maine Prisoner's Hunger Strike Over

Guess this kind of moots the interesting constitutional confrontation up there: Inmate James Emerson ended his month-long hunger strike with a peanut butter sandwich on Saturday night, followed by eggs and toast, some canned pears and two glasses of juice the next morning, according to a story in Monday's Bangor Daily News. Previous posts on this story are here and here. [tm]

Abortion After Roe

David Crary of the AP has filed a story on the political and health changes that would be wrought if the Supreme Court were to reverse Roe v. Wade.  There are no great surprises here, but it summarizes the issues well and offers some good quotes.  The biggest question mark: state Republican lawmakers, who have made careers by criticizing Roe without having to actually cast a vote to restrict reproductive choice in their state, would have to confront the political reality of such a vote for perhaps the first time in their careers.  [tm]

Cartoon Roundup

A feature I used to love doing back when I was running HealthLawBlog -- and the thought of copyright violations didn't bother me, because it was only my butt that was on the line and not Betsy's and Paul Caron's -- was a weekly roundup of political cartoons on health care issues.  I ran the cartoons (with attribution, of course) and nobody complained, presumably because my theory of what constitutes Fair Use was completely persuasive to the legal beagles at Universal Press Syndicate and other purveyors of fine political commentary.

Well, even if I can't run the panels on this page (by the way, didn't we used to say "what happens on healthlawprof blog stays on healthlawprof blog"?), I can run the links.  And what you do with the cartoons in your own classrooms, well, that's your business . . . .

Overview: Clear winners in the topical sweepstakes for this week: avian flu and the nomination of Sam Alito to replace S.D. O'C on SCOTUS . . . .

Medicare Reform/Drug Benefit
Signe Wilkinson (Phila. Daily News)

Avian Flu
Stuart Carlson (Milwaukee Sentinel)
Mike Luckovich (Atlanta Constitution)
Dick Locher (Chicago Tribune)
Lalo Alcaraz (Universal Press Syndicate)
Mike Luckovich (Atlanta Constitution)
Pat Oliphant (Universal Press Syndicate)
Jack Ohman (The Oregonian)
Pat Oliphant (Universal Press Syndicate)
Ben Sargent (Austin American-Statesman/UPS) (in honor of the first weekend of deer-hunting season here in the Lone Star State)

Supreme Court/Roe v. Wade
Ann Telnaes (CWS/NYTS)
John Deering (Arkansas Democrat-Gazette)
Signe Wilkinson (Phila. Daily News)
Pat Oliphant (Universal Press Syndicate)
Steve Kelley (New Orleans Times-Picayune)
Ann Telnaes (CWS/NYTS)
Drew Sheneman (The Star-Ledger (Newark, N.J.))

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Bird Flu Update

From the AP( mostly) and others:

• China Turns to WHO for Bird Flu Help - China said Sunday it had asked the World Health Organization to help it determine whether the death of a 12-year-old girl last month was caused by bird flu. If it is confirmed, it would be China's first known human death from the lethal and virulent H5N1 strain of bird flu.
• Supporters: Cockfight Bill Could Stem Flu - A cockfighting bill aimed at stemming the spread of bird flu to the U.S. has stalled despite support from the Bush administration and the poultry industry. The bill targets trade from Southeast Asia, where cockfighting is suspected of spreading bird flu from chickens to humans.
• Bird Flu Plans: Prudent or Overreaction? - Don't worry if you missed it when the Bush administration released its draft in August 2004 for fighting a potential flu pandemic. So did most of the rest of the country. The draft generated fewer than 50 public comments for the Health and Human Services Department to consider.
• Hawaii Begins Airport Watch for Bird Flu - Hawaii became the first state in the nation this week to monitor airports for signs of bird flu or other flu viruses, health officials said.
• States Have Their Own Plans for Bird Flu - States have their own ideas for dealing with an outbreak of bird flu or other super-flu strain - readying possible quarantine sites and talking about closing schools and businesses. State officials may tell hospitals they may have to evict all but the most critically ill.
• China, Vietnam report new bird flu outbreaks - China reported its fourth bird flu outbreak in three weeks, saying that 8,940 chickens died in a northeastern village despite a nationwide effort to contain the virus.
• Canada braces for bird flu - Amid recent concerns that avian influenza could enter the lower United States via birds traveling from the North, just what is neighboring Canada doing to prevent and prepare for a possible outbreak?

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Avian Flu Editorials

The New York Times has two interesting editorials on the avian flu.  The first is by former Speaker of the House Newt Gringrich and Robert Egge.  They argue that the government needs to change dramatically to ensure an adequate response to the upcoming pandemic.  They state,

What we need to do to prepare for and respond to a pandemic is change the very way the government delivers services. And to do that, the following initiatives must be integrated into the government's response:

Designate a single, accountable leader. An avian flu pandemic is among the greatest threats to our country today. Given our vulnerability and the amount of work to be done, the president must appoint a leader who is singularly focused on avian flu. This leader must be fully accountable for the government's progress. And the president must make it clear that this leader speaks on his behalf. . . .

 

Replace bureaucratic administration with entrepreneurial management. If an avian flu pandemic sweeps the United States, it will pose a tremendous challenge in terms of speed, lethality and complexity. Federal, state and local governments will need to act with the speed and agility of the information age.

Prepare for the days of a phony war mentality. Until we receive word that a pandemic is loose in this country, last week's announcement could well be the high point of public attention to the threat posed by avian flu. The pressure to prepare will decline. And as this happens, government attention will be pulled in other directions. . . .

A leading example of such an investment is an electronic health record system, which would allow the federal government to track the course and impact of a pandemic in real time. Public health experts widely agree that this kind of network would not only allow for safer and more efficient care under normal circumstances, but would also equip federal, state and local governments with the data needed to direct scarce therapies, medical teams and supplies to where they are most needed as a pandemic unfolds. There's no good reason why every American couldn't have a preliminary electronic health record by the end of 2006.

Just a few of their suggestions that didn't strike me as as too outlandish.  The second editorial is by Olivia  judson and discusses how the evolving avian flu strand should demonstrate for all the validity of Darwin's theory of evolution and importance in the classroom.  She concludes,

But the most important point is this: viruses and other pathogens evolve in ways that we can understand and, to some extent, predict. Whether it's preventing a flu pandemic or tackling malaria, we can use our knowledge of evolutionary processes in powerful and practical ways, potentially saving the lives of tens of millions of people. So let's not strip evolution from the textbooks, or banish it from the class, or replace it with ideologies born of wishful thinking. If we do, we might find ourselves facing the consequences of natural selection.

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Maine's Prisoner Case: Right to Die? To Commit Suicide?

Here's a follow-up on