HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, January 1, 2005

Happy New Year!

Happy New Year!Biscuit_bandit  From Betsy, Matt and Luke Malloy

January 1, 2005 | Permalink | Comments (0)

Final HIPAA Portability Rule Published

Remember the old days, when "HIPAA" signaled "health insurance portability" and (more or less) the end to group-health exclusions based upon pre-existing conditions?  That 1996 statute has existed for more than 8 years without a final rule (though, to be fair, there has been an "interim final rule" since 1997).  The situation changed on Dec. 30, when HHS published its final rule in the Federal Register.  For a quick summary, check out the HHS news release.  The final regulation becomes effective for plan years starting on or after July 1, 2005.

HHS jointly published the final rule with the Departments of Treasury and Labor.  They also jointly published a new proposed rule to deal with certain features of the law and

a Request for Information about experiences with benefit-specific waiting periods imposed by group health plans and group health insurance issuers. It also seeks suggestions for devising an appropriate test for determining when a benefit-specific waiting period is a preexisting condition exclusion.  Some group health plans and group health insurance issuers impose benefit-specific waiting periods on specific conditions or treatments, such as a two-year restriction on benefits for transplants. To the extent such a waiting period constitutes a preexisting condition exclusion, the waiting period is subject to HIPAA's limitations on preexisting condition exclusions.


January 1, 2005 | Permalink | Comments (0)

BMJ: Lilly Knew of Prozac Risks in 1980s

It's going to be a rough year (and then some) for Eli Lilly, if the British Medical Journal (BMJ) is right about documents that have been missing for 10 years and the journal received from a confidential source last month.  According to a news story by Jeanne Lenzer  in the current (Jan. 1) issue, officials at Lilly knew about the increased suicide risk associated with Prozac use.  According to the article, "Dr Richard Kapit, the FDA clinical reviewer who approved fluoxetine, said he was not given the Lilly data. 'These data are very important. If this report was done by Lilly or for Lilly, it was their responsibility to report it to us and to publish it.'"  The article provides a concise review of the past year's Prozac-related developments, including the FDA's recent public health advisory about antidepressants, and an on-going review by a member of Congress:

Congressman Maurice Hinchey's office is currently reviewing the documents to determine whether Lilly withheld data from the public and the FDA. Mr Hinchey (Democrat, New York) said: "This is an alarming study that should have been shared with the public and the FDA from the get-go, not 16 years later.

"This case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks."

As The New York Times' Ken Belson reported in this morning's paper, Lilly's stock took a hit after news of the BMJ article hit the street.  Bloomberg fleshes out the story nicely, as well.  [tm]

January 1, 2005 | Permalink | Comments (2)

Friday, December 31, 2004

New Doctor-Approved Plastic Wristbands

Doctors in Southern Illinois are handing out their own plastic wristbands modeled on those I mentioned earlier (the ones to promote various charities that some hospitals worry cause confusion with hospital bracelets).   These new doctor-approved and promoted wristbands are bright green and contain a slogan as well.  You might guess that the slogan is something like:  Eat More Veggies or Stop Smoking or Walk More.  You would be wrong.  Instead, the green wristbands promote tort reform.  The AMNews reports that the wristband states, "Keep Doctors In Illinois" in black letters and that Illinois physicians hope that the bracelets will rally support across the state for the passage of tort reform. 

I can understand wanting to get your message out in a trendy fashion but using a technique associated with charitable health campaigns seems to be in questionable taste.  According to the article, the doctors are not charging for the bracelets.  The funding for them came from a pharmaceutical company and some local hospitals.  Also, the bright green color is unlikely to one confused with any current plastic wristband a hospital might use.


December 31, 2004 | Permalink | Comments (0)

Mental Health Article - The New Yorker

An article in this week's New Yorker magazine by Alix Spiegel examines how psychiatrist Robert Spitzer transformed the Diagnostic and Statistical Manual of Mental Disorders into the invaluable publication it is today.   The article states,

"Robert Spitzer isn’t widely known outside the field of mental health, but he is, without question, one of the most influential psychiatrists of the twentieth century. It was Spitzer who took the Diagnostic and Statistical Manual of Mental Disorders—the official listing of all mental diseases recognized by the American Psychiatric Association (A.P.A.)—and established it as a scientific instrument of enormous power. Because insurance companies now require a DSM diagnosis for reimbursement, the manual is mandatory for any mental-health professional seeking compensation. It’s also used by the court system to help determine insanity, by social-services agencies, schools, prisons, governments, and, occasionally, as a plot device on “The Sopranos.” This magnitude of cultural authority, however, is a relatively recent phenomenon . . . .  Under Spitzer’s direction—which lasted through the DSM-III, published in 1980, and the DSM-IIIR (“R” for “revision”), published in 1987—both the girth of the DSM and its stature substantially increased. It is now nine hundred pages, defines close to three hundred mental illnesses, and sells hundreds of thousands of copies, at eighty-three dollars each. But a mere description of the physical evolution of the DSM doesn’t fully capture what Spitzer was able to accomplish. In the course of defining more than a hundred mental diseases, he not only revolutionized the practice of psychiatry but also gave people all over the United States a new language with which to interpret their daily experiences and tame the anarchy of their emotional lives.


December 31, 2004 | Permalink | Comments (1)

Health Affairs' 25 Most-Read Articles

Health Affairs, the pre-eminent journal on health policy and economics, recently listed it's 25 most-read articles in 2004, and has made the Top Ten available for free on its web site until January 12.  Here's the list:

1. U.S. Health Care Spending in an International Context
Uwe E. Reinhardt, Peter S. Hussey, Gerard F. Anderson,
Health Affairs, May/June 2004.

2. Which Medical Conditions Account for the Rise in Health Care Spending?
Kenneth E. Thorpe, Curtis S. Florence, Peter Joski,
Health Affairs, Web Exclusive, August 25, 2004

3. How Does the Quality of Care Compare in Five Countries?
Peter S. Hussey, Gerard F. Anderson, Robin Osborn, Colin Feek,
Vivienne McLaughlin, John Millar, Arnold Epstein
Health Affairs, May/June 2004.

4. The Working Hours of Hospital Staff Nurses and Patient Safety
Ann E. Rogers, Wei-Ting Hwang, Linda D. Scott, Linda H. Aiken, David F. Dinges,
Health Affairs, July/August 2004.

5. Health Spending Rebound Continues in 2002
Katharine Levit, Cynthia Smith, Cathy Cowan, Art Sensenig,
Aaron Catlin, the Health Accounts Team
Health Affairs, Jan/Feb 2004.

6. Health Spending Projections through 2013
Stephen Heffler, Sheila Smith, Sean Keehan, M. Kent Clemens, Mark Zezza, Christopher Truffer,
Health Affairs, Web Exclusive, Feb. 11, 2004.

7. Are Market Forces Strong Enough to Deliver Efficient
Health Care Systems? Confidence Is Waning

Len M. Nichols, Paul B. Ginsburg, Robert A. Berenson,
Jon Christianson, Robert E. Hurley
Health Affairs, Mar/Apr 2004.

8. Tracking Health Care Costs: Trends Turn Downward In 2003
Bradley C. Strunk, Paul B. Ginsburg,
Health Affairs, Web Exclusive, June 9, 2004.

9. The Medical Malpractice ‘Crisis’: Recent Trends And The Impact Of State Tort Reforms
Kenneth E. Thorpe
Health Affairs, Web Exclusive, January 21, 2004.

10. Managed Care Rebound? Recent Changes In Health Plans’ Cost Containment Strategies
Glen P. Mays, Gary Claxton, Justin White,
Health Affairs, Web Exclusive, August 11, 2004.

11. Medicare Spending, The Physician Workforce, And Beneficiaries’ Quality Of Care
Katherine Baicker, Amitabh Chandra,
Health Affairs, Web Exclusive, April 7, 2004.

12. The Changing Structure of the Pharmaceutical Industry
Iain M. Cockburn
Health Affairs, Jan/Feb 2004.

13. Use Of Medicare Claims Data To Monitor Provider-Specific Performance Among Patients With Severe Chronic Illness
John E. Wennberg, Elliott S. Fisher, Thérèse A. Stukel, Sandra M. Sharp,
Health Affairs, Web Exclusive, Oct 7, 2004.

14. Physicians’ Use Of Electronic Medical Records: Barriers And Solutions
Robert H. Miller and Ida Sim,
Health Affairs, Mar/Apr 2004.

15. Is the Current Shortage of Hospital Nurses Ending?
Peter I. Buerhaus, Douglas O. Staiger, David I. Auerbach
Health Affairs, Nov/Dec 2003.

16. Increasing Obesity Rates And Disability Trends
Roland Sturm, Jeanne S. Ringel and Tatiana Andreyeva
Health Affairs, Mar/Apr 2004.

17. The Forgotten Third: Liability Insurance and the Medical Malpractice Crisis
William M. Sage
Health Affairs, July/August 2004.

18. Financial Pressures Spur Physician Entrepreneurialism
Hoangmai H. Pham, Kelly J. Devers, Jessica H. May, Robert Berenson
Health Affairs, Mar/Apr 2004.

19. Employers’ Contradictory Views About Consumer-Driven Health Care: Results From A National Survey
Jon R. Gabel, Heidi Whitmore, Thomas Rice, Anthony T. Lo Sasso,
Health Affairs, Web Exclusive, April 21, 2004.

20. Treatment of People with Mental Illness: A Decade-Long Perspective
David Mechanic, Scott Bilder
Health Affairs, July/Aug 2004

21. Trends In International Nurse Migration
Linda H. Aiken, James Buchan, Julie Sochalski, Barbara Nichols, Mary Powell,
Health Affairs, May/June 2004.

22. Evidence-Based And Value-Based Formulary Guidelines
Peter J. Neumann,
Health Affairs, Jan/Feb 2004.

23. What Is Driving Hospitals’ Patient-Safety Efforts?
Kelly J. Devers, Hoangmai H. Pham and Gigi Liu
Health Affairs, Mar/Apr 2004.

24. New Signs Of A Strengthening U.S. Nurse Labor Market?
Peter I. Buerhaus, Douglas O. Staiger, David I. Auerbach
Health Affairs, Web Exclusive, November 17, 2004.

25. How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?
Amir Attaran
Health Affairs, May/June 2004.


December 31, 2004 | Permalink | Comments (0)

New Journal Issues Call for Papers

From the Cambridge University Press:

Health Economics, Policy and Law
Cambridge University Press is delighted to announce the launch of a new quarterly journal, Health Economics, Policy and Law for 2006. International trends highlight the confluence of economics, politics and legal considerations in the health policy process. Health Economics, Policy and Law will serve as a forum for scholarship on health policy issues from these perspectives, and will be of use to academics, policy makers and health care managers and professionals. HEPL will be international in scope, and will publish both theoretical and applied work. Considerable emphasis will be placed on rigorous conceptual development and analysis, and on the presentation of empirical evidence that is relevant to the policy process. The definition of health policy will be broad, and will include factors that affect health but that transcend health care, and factors that only indirectly affect health, such as legal and economic considerations in medical research. Articles on social care issues will also be considered. The most important output of HEPL will be original research articles, although the editors also encourage readers to propose subjects for editorials, review articles and debate essays.

Call for Papers
HEPL invites high quality contributions in health economics, political science and/or law, within its general aims and scope. The recommended text-length of articles is 6-8,000 words for original research articles, 2,000 words for guest editorials, 5,000 words for review articles, and 3,000 words for debate essays. All articles should be written in English, and should follow the instructions for contributors, which can be found at:

All contributions and general correspondence should be sent to:
Anna Maresso, Managing Editor
LSE Health and Social Care London School of Economics and Political Science
Houghton Street
London WC2A 2AE UK



December 31, 2004 | Permalink | Comments (1)

Thursday, December 30, 2004

New Trial Denied in Schiavo Case

Gretchen Moore, over at JURIST, filed a report this morning saying that "[t]he Florida 2nd District Court of Appeal Wednesday denied a request from the parents of Terri Schiavo for a new trial in her long-running right-to-die case. Once the court issues a formal decision within two weeks, Schiavo's husband will be able to order the removal of a feeding tube that has kept his wife alive for over 14 years. Schiavo's parents argued for a new trial based on the Pope's recent statements regarding the rights of people in vegetative states."  The AP story is here, and the court's electronic docket sheet for the case (No. 2D04-4755) is here.

The prediction that Michael Schiavo will be able to order the removal of Terri Schiavo's feeding tube sometime in the next two weeks may prove to be optimistic.  Her parents can be counted on to move to stay the appellate court's mandate until they can prepare an appeal to the Supreme Court of Florida.  The courts could decide that 14 years and countless motions to reconsider, rehear, and retry -- with countless trips to the appellate courts -- make it virtually impossible for the parents to show a likelihood of prevailing on the merits.  But irreparable harm, though something of a mixed bag, might be thought to favor the parents in this life-and-death struggle.  And with Gov. Jed Bush's cert. petition in his "Terri's Law" litigation pending in the Supreme Court (No. 04-757; docket), it is probably anyone's guess whether the Florida courts are yet willing to say enough is enough.

The Governor's petition can be found here (PDF) on the Terri's family's web site,  Lyle Denniston's analysis of the Governor's arguments can be found over at SCOTUSblog[tm]

December 30, 2004 | Permalink | Comments (0)

How to help: Tsunami Relief Agencies

As the continuing bad news from the tsunami diaster and death toll continues to overwhelm us, many are wondering what they can do to help.  The Washington Post today has a list of relief agencies that are accepting donations for their work in the tsunami areas.


December 30, 2004 | Permalink | Comments (1)

Study of Big Foot

If you are interested in a completely different type of research study reading for over the holidays, well, I think I can guarantee that this will be the most unusual.  Professor David Daegling, an anthropologist at the University of Florida has recently published “Bigfoot Exposed: An Anthropologist Examines America’s Enduring Legend.”     According to an article on the Unversity of Florida's website, Professor Daegling's book "examines some of the most celebrated Bigfoot claims regarding the number, size and frequency of footprints found deep in the forest, hair samples that defy description and famous film footage that some people hold up as the strongest proof of the creature’s existence."  The article further states the author's reason behind this study,

“People express a reverence for the grandeur of the animal and derive meaning from Bigfoot because it represents where we came from,” said UF anthropologist David Daegling. “I think Bigfoot depicts the wild and uncultured side of who we are, a side we are both attracted to and repulsed by.”

The book is available from Altamira Press.  I don't know about you but I am seriously re-thinking my scholarly agenda . . .


December 30, 2004 | Permalink | Comments (0)

Washington State Moves Closer to Med-Mal Caps

At precisely the same time med-mal reform seems to be self-destructing in Maryland, Washington is moving closer to caps on med-mal verdicts for pain and suffering.  As reported on Dec. 29 in the Seattle Post-Intelligencer:

Sponsors of an initiative to cap "pain and suffering" damage awards in medical malpractice cases submitted about 315,000 petition signatures yesterday.

Initiative 330, dubbed the "Health Care Access Initiative," was written by the medical community and sets up a showdown with a rival initiative sponsored by trial lawyers, labor and a coalition of activists.

The measures are likely to end up on the statewide ballot in November, but are headed to the Legislature first.

Lawmakers have three options with each measure: Pass it into law, ignore it and send it to the ballot, or send it and a legislative alternative to the voters.

Although the Democrats will control both houses of the Legislature and a Democrat will probably occupy the governor's mansion, most observers expect lawmakers to debate the topic, but send the final decision to the people.

The Washington State Medical Association's web site on the bill is here.

The Secretary of State's description of the initiative is here.  The text of the initiative is available on the SOS web site in HTML and  PDF[tm]

December 30, 2004 | Permalink | Comments (0)

Maryland Med-Mal Reform Appears Headed for Veto

As reported in Wednesday's Washington Post ("Differing Bills Face Same Fate: Ehrlich's Veto," by John Wagner and Matthew Mosk), competing bills in the Maryland Senate and House of Delegates offer different levels of curbs on malpractice lawsuits but share one thing in common: a tax on HMO premiums that the governor considers a deal breaker.  So, med-mal reform that was described here in an earlier post is widely considered to be a dead letter in Maryland, at least for this special legislative session.  [tm]

December 30, 2004 | Permalink | Comments (0)

Are C-Sections Evolutionarily Favored?

Brainevolutionhuman In a copyrighted story in the Dec. 29 Chicago Tribune (free subscription required), science reporter Ronald Kotulak reports ("Study charts expansion of human brain"):

The first study of genes that build and operate the brain shows that humans underwent a unique period of rapid brain expansion that endowed them with a special form of intelligence not shared by any other animal, according to University of Chicago researchers.

The colossal leap forward grew the human brain to three or four times the size of that of a chimpanzee--man's closest genetic relative--when body sizes are equalized. That vast computing power pushed human intelligence over the threshold of basic instincts and into an unparalleled realm of cognition, self-awareness and consciousness.

Brain size, therefore, appears to have given humans the evolutionary edge over our genetic near-relations.  Is there any limit to the advantage brain size confers on our species?  Not after the development of the C-section:

Brain size was thought to have hit its maximum because a larger skull would not be able to squeeze through the birth canal. But Caesarean sections--the practice of surgically removing a baby from the womb--could eliminate those limitations, [Univ. of Chicago geneticist Bruce] Lahn noted.

"With the C-section, we have just lifted a huge barrier to how big the brain can be," he said. "I wouldn't be surprised if in a few hundred years C-sections [account for] almost 100 percent [of births]."


December 30, 2004 | Permalink | Comments (0)

Wednesday, December 29, 2004

Drug Sample Sales Scheme Nets Indictments

As reported yesterday in the Philadelphia Inquirer, "Federal authorities in Philadelphia charged three pharmacists and two doctors yesterday with illegally selling hundreds of thousands of pills, including popular medications Prilosec, Celebrex and Prozac, that drug companies had handed out as promotional free samples."  As remarkable as is the defendants' alleged abuse of their patients' trust, the dollars and quantities of samples involved offer a glimpse into the extent of pharmaceutical companies' "free sample" marketing programs:

Drug-sample sales defrauded customers and third-party pharmacy benefit managers, which ultimately paid for what had been free samples, said David R. Hoffman, the assistant U.S. attorney in Philadelphia who is prosecuting the case.

According to court papers, pharmacists bought thousands of samples at steep discounts from doctors or drug company salesmen, broke open the individualized packages, and dispensed the medications with other pills in inventory. The process of selling the drug samples - which took place between 1993 and mid-2001 - also made it impossible to track the safety of the medications, Hoffman said. An investigation is continuing.

Charged yesterday with conspiracy to commit health-care fraud and illegally selling prescription drugs were pharmacists Mark Rubin, 51, of Southampton; Bruce Goldberg, 53, of Huntingdon Valley; and Howard Dall, 58, of Ambler. All three face substantial jail time and fines if convicted.

Rubin owned the Summerdale Pharmacy, and Goldberg owned the K&A Pharmacy and the Marcus Foster Pharmacy, all three in Philadelphia, court records state. Dall owned Ralph's Pharmacy in Conshohocken and the Gladwyne Pharmacy. The U.S. attorney noted that the defendants no longer own any of the five pharmacies.

Rubin paid about $500,000 from January 1993 through September 2000 for free samples of drugs that included Celebrex, Paxil, Prozac, Serzone, Biaxin, Augmentin, Zyprexa and Remeron. Goldberg spent about $250,000 on free samples. Court records did not state how much Dall paid for the free samples.


December 29, 2004 | Permalink | Comments (0)

JAMA Article on Arthitis Medication

The January 19, 2005 issue of JAMA contains an article on the recent data concerning the cardiovascular risks of cox-2 inhibitors.


December 29, 2004 | Permalink | Comments (0)

Most Trusted Professional

According to a 2004 Gallop Survey, Nurses top the list of the most trusted professional.  They have held the top spot for 5 of the last 6 years.  Doctors fell from 2d place in 2003 to 5th place in 2004.   Lawyers ranked 19th out of the 21 professional on the survey.  The lowest ranking went to car salepeople.


December 29, 2004 | Permalink | Comments (0)

Tuesday, December 28, 2004

Charity Bracelets Pose Risk

Many people wear the Lance Armstrong "LIVESTRONG" bright yellow bracelet.  Indeed, over 20 million of the bracelets have been sold since last May.  Well, they might want to consider not wearing that bracelet as well as several others supportive of a variety of charities to the hospital.  According to the AMA News, the yellow color of the Lance Armstrong bracelet matches the yellow wrist bands that certain hospitals place on patients' wrists to indicate at do-not-resuscitate order or for other serious designations.   Hospitals fear that even though the bracelets are of different materials, the similar colors may cause confusion in an emergency situation.  Some hospitals have asked patients to tape over the bracelet to minimize the risk.


December 28, 2004 | Permalink | Comments (2)

Stem Cell Research - A Solution?

The AMA News reports on a development that may provide a solution to the embroyic stem cell research debate.   During the November 2003 meeting of the President's Council on Bioethics, council member William B. Hurlbut, MD, a Stanford University consulting professor in human biology, presented a plan to create a new entity that produced embryonic stem cells but would lack the ability to later develop into an embryo.   The report states,

"The proposal involves creating a new type of biological entity that can produce stem cells but would not rise to the moral status of a human embryo. Reaction has been mixed, but with embryonic stem cell research opponents -- including an influential official of the Catholic church -- expressing interest, both sides might be persuaded to give it another look."

Of course, as the report also notes, this does not end the debate.  It quotes Dr.  Hurlbut acknowledging this fact,

"The chief complaint from one side is that I was proposing to create true embryos with a defect," he said. "The criticism from the other side is, 'Why should science accommodate the private religious views of a small number of people?' "


December 28, 2004 | Permalink | Comments (1)

Illinois Referral Case: Split Opinion

As reported by Mealey's Legal News/Health Care:

SPRINGFIELD, Ill. — An Illinois appeals court in a divided Dec. 9 opinion held that a flat fee charged by the creator of a health network improperly required participating physicians to pay a fee for the referral of patients but affirmed that the plaintiffs were not entitled to recover fees already paid (Vine Street Clinic, et al. v. HealthLink Inc., No. 4-03-0876, Ill. App., 4th Dist.).

The decision is available here (PDF; Lexis/Nexis subscription required), here (requires WestLaw subscription), and here (slip opinion; free).

As the court wrote: "This case presents the question whether a company that creates a list of health-care providers that it makes available for a charge to members of health plans may enter into an agreement under which the health-care providers themselves would pay [a percentage fee] to be included on the list. We conclude the agreement improperly requires physicians to pay a fee for the referral of patients." [tm]

December 28, 2004 | Permalink | Comments (0)

Monday, December 27, 2004

Spector v. Norwegian Cruise Line

Shiplogo The disability law case, Spector v. Norwegian Cruise Line, will be argued before the Supreme Court on Monday, February 28th, 2005.  The case concerns the application of Title III of the Americans with Disabilities Act (ADA) to foreign-flag cruise ships in United States waters.  Title III bars discrimination against the disabled in places of "public accommodation."

The issue arose when Mr. Spector, who rides a motorized scooter because a tumor on his spine makes walking impossible, took a cruise on a Norwegian Cruise Line ship.  According to Mr. Spector, the ship was very ill-equipped for disabled passengers.   Not only did the ship not have ramps for access to restaurants, swimming pools, restrooms and even lifeboats, but they charged him extra for a disability accessible cabin.   

In a class action lawsuit, he and the other plaintiffs sued requesting injunctive relief that would require the cruise line to remove the barriers  preventing disabled passengers from moving around the ship freely.  The U.S. District Court for the Southern District of Texas ruled that Title III applies to foreign ships within U.S. territorial waters.   The Fifth Circuit Court of Appeals in an opinion authored by Judge Edith H. Jones, unanimously reversed, saying Title III does not apply to foreign ships because there is no evidence that Congress intended the law to affect these ships.  The Fifth circuit’s decision conflicts with the Eleventh circuit, which decided per curiam in 2000 that Title III did apply to foreign-flagged cruise ships, Tammy Stevens v. Premier Cruises, Inc. 

The briefs of the parties and various amicus briefs are available at SCOTUSblog.


December 27, 2004 | Permalink | Comments (0)