December 3, 2005
Pfizer Gives Boot to Whistleblower
The NY Times reported yesterday that Pfizer had terminated the employment of its Vice-President for Marketing Peter Rost "after a federal judge in Boston unsealed a lawsuit Mr. Rost filed in June 2003 against Pfizer, asserting that Pharmacia, a drug maker Pfizer bought in April 2003, illegally promoted the sale of human growth hormone for unauthorized uses."
As The Times reports:
Mr. Rost contends that Pharmacia offered doctors illegal inducements to use genotropin, its growth hormone, as an anti-aging drug for adults. The Food and Drug Administration has not approved human growth hormone for that purpose, and drug makers are not supposed to promote their products for purposes that have not received approval.
The fact that the suit was unsealed is actually a positive development for Pfizer, because it indicates that the government has chosen not to participate in the suit alongside Mr. Rost. Whistle-blower lawsuits typically remain secret when the government participates.
For those of you who want to dig a little deeper, the Docket Number is 1:03-CV-11084-JLT (D. Mass.; Judge Joseph Tauro and Magistrate Judge Robert Collings).
- The DOJ's "Notice of Election to Decline Intervention" is here: DOJ declines_intervention.pdf.
- The court's order to unseal the suit is here: Order_to_unseal.pdf.
Meanwhile, on Dec. 1 Pfizer filed a motion to dismiss (Motion_to_dismiss.pdf) based largely on the affidavit of one of its attorneys (Posner_affidavit.pdf) to the effect that Rost's False Claims Act qui tam action was based upon facts previously disclosed to the government.
So, here's my question: How can Pfizer fire Rost, after the U.S. declines to intervene in Rost's qui tam action but while Rost's action against Pfizer is still pending, in light of the following language in 31 USC § 3730(h):
(h) Any employee who is discharged . . . by his or her employer because of lawful acts done by the employee on behalf of the employee or others in furtherance of an action under this section, including investigation for, initiation of, testimony for, or assistance in an action filed or to be filed under this section, shall be entitled to all relief necessary to make the employee whole. Such relief shall include reinstatement with the same seniority status such employee would have had but for the discrimination, 2 times the amount of back pay, interest on the back pay, and compensation for any special damages sustained as a result of the discrimination, including litigation costs and reasonable attorneys’ fees. An employee may bring an action in the appropriate district court of the United States for the relief provided in this subsection.
Pfizer can argue that it didn't fire Rost because of his prosecution of the qui tam action, but that looks like an uphill battle in light of the sequence of events. [tm]
JCAHO Safety Goals May Address Disruptive Staff
Well, this should add a little spice to the physician peer-review stew:
The Joint Commission on Accreditation of Healthcare Organizations proposes to call on hospitals to develop codes of conduct to reduce risks to patient safety associated with disruptive behavior by staff and to create processes for managing staff fatigue, among other new patient safety goals for 2007. The JCAHO is accepting public comment on the proposal until Jan. 8, 2006, and expects to release a final list of patient safety goals in July. [From Modern Healthcare]
You can read the proposal here. [tm]
December 2, 2005
Calif. Appellate Court Rules in Religion- Based Treatment Refusal Case
N. Coast Women's Care Med. Group v. Superior Court (12/02/05 - No. D045438)
Summary adjudication for plaintiff on an affirmative defense to a civil rights claim involving defendants' refusal to perform intrauterine insemination (IUI) is reversed where evidence presented by defendants raised a triable issue of fact as to whether the basis for defendants' religiously-based refusal to perform IUI was plaintiff's marital status and not her sexual orientation.
The interest in this case has been intense, as evidenced by the number of amici who filed briefs in the court of appeals. Amici curiae briefs in support of defendants' petition have been filed by the California Medical Association and the Christian Medical and Dental Associations. An amici curiae brief supporting plaintiff and the trial court's summary adjudication ruling was filed by the following organizations: Anti-Defamation League; American Academy of HIV Medicine; American Medical Students Association; Asian Pacific American Legal Center of Southern California; Bienestar Human Services; California Latinas for Reproductive Justice; California Pan-Ethnic Health Network; California Women's Law Center; Coalition for Humane Immigrant Rights of Los Angeles; Gay and Lesbian Medical Association; International Association of Physicians in AIDS Care; Latino Coalition for a Healthy California; Mautner Project; National Center for Lesbian Rights;Mexican American Legal Defense and Educational Fund; and National Health Law Program. [tm]
Living Wills and Pregnancy Clauses (Canadian Style)
University of Toronto SJD candidate Daniel Sperling has published "Do Pregnant Women Have (Living) Will?," in 8 J. of Health Care L. & Pol'y 331 (2005). Here is the abstract of his article:
Living wills are documents that instruct health care providers about particular kinds of medical care that an individual would or would not want to have if rendered incompetent.
Under the American legal system, living wills of pregnant women are not legally binding or enjoy a much weaker effect than those of other women, not to mention those of other men.
In Canada, however, the law is silent on this matter. From this silence one can infer either that the legislators were not fully aware of the possibility that incompetency may also occur during pregnancy or that Canada considered the American model and decided not to follow it. By analyzing the American and English legal opinions on pregnancy clauses in living will legislation, this article calls for the adoption of an original Canadian approach deviating from the American model, thereby giving full legal effect to the living will of an incompetent pregnant woman.
The full article is available here. [tm]
December 1, 2005
FTC Affirms ALJ's Ruling Against North Texas IPA
There are two nonsurprises in today's story (from Modern Healthcare [requires paid subscription]):
1. "The Federal Trade Commission affirmed a 2004 ruling from an FTC administrative law judge that found an independent practice association had illegally fixed prices in the Dallas-Fort Worth market. . . . In an order today, the FTC commissioners banned 480-physician North Texas from contracting with payers on behalf of members except in the case of qualified risk-sharing and clinically integrated arrangements." The FTC decision page is here.
2. The IPA plans to appeal.
As the FTC's opinion points out, "This is the first physician network case in over 20 years where the Commission has the benefit of a full administrative trial and record. This case thus presents an opportunity not only to resolve a specific controversy but also to provide some guidance to the health care community on the appropriate boundary between pro-competitive and anti-competitive activities." For this reason alone, this opinion will be poured over for weeks and months to come. [tm]
DHS to Include Nuclear Medicine
Here's a tidy little message from the folks at Davis Wright Tremaine, LLP:
In regulations released on Nov. 21, 2005 [the rule was published in the Federal Register on Nov. 21; the press release on this is dated Nov. 2], the Centers for Medicare and Medicaid Services (CMS) announced its decision to bring nuclear medicine within the scope of the Stark rules by Jan. 1, 2007. Although CMS and physician-investors disagree on whether “fire sales” will result, it is clear that many financial relationships will need to be restructured over the next year. According to CMS, a physician who has invested in either nuclear medicine equipment or a facility that provides nuclear medicine services has three options:
(1) divest the interest;
(2) restructure the financial relationship so that it complies with an exception; or
(3) maintain the interest and refer his or her patients to another entity.
The firm's bulletin also includes a brief but illuminating discussion on "the tortured history of nuclear medicine." [tm]
Harvard Law School to Launch Bioethics & Technology Center
In case you missed the N.Y. Times story on this, Harvard Law School announced its plan to launch the Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. See also our earlier post on the Center's fellowship announcement. [tm]
Regulating Human Biological Enhancements
Stanford Law Prof. Hank Greely has published "Regulating Human Biological Enhancements: Questionable Justifications and International Complications," in a joint issue of the University of Technology Sydney Law Review/Santa Clara Journal of International Law (2005). Here's the abstract of Prof. Greely's paper:
Ethical and social issues involved in human biological enhancements have been increasingly controversial, whether in the form of steroids in sports, of genetic selection for better children, or of study pills for cognitive enhancement. This article begins with examples of controversial human biological enhancements and a review of the arguments against such enhancements. Next, it intensively examines whether human biological enhancements are meaningfully different from other kinds of human enhancement. Then it analyzes ways in which human cultural diversity and splintered political sovereignty cut against effective curbs on such enhancements. The article concludes that human biological enhancements are not inherently different from other forms of enhancing technologies and that regulation of enhancement technologies remains a challenge.
The full paper can be downloaded here. [tm]
November 30, 2005
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:
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
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.
November 29, 2005
8th Circuit Strikes Down Missouri's Partial-Birth Abortion Law
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"
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.
November 28, 2005
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.
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
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]
November 27, 2005
Wennberg on Practice Variations in California
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).
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:
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.
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]