HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Friday, December 24, 2004

Medicare's New Coverage for Smoking Cessation Programs

Here's a health maintenance program worthy of the label.  On Dec. 23 CMS announced it was going to start covering the costs of smoking cessation programs for seniors with health conditions related to their smoking.  As reported by Robert Pear in today's New York Times:

Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services, said: "Millions of our beneficiaries have smoked for many years and are now experiencing heart problems, lung problems and other diseases that smoking can cause. Just about all of them will be eligible for the new coverage. You're never too old to quit smoking and to get benefits of quitting."

The new coverage will be available to Medicare beneficiaries who have illnesses caused or complicated by smoking. These include heart disease, stroke, lung cancer, emphysema, weak bones, blood clots and cataracts, which together account for the bulk of Medicare spending.

Medicare will also cover counseling services for beneficiaries who take any of the drugs whose effectiveness can be compromised by the use of tobacco. These medications include insulin and drugs for high blood pressure, seizures and depression.

Over time, improvements in the health of beneficiaries should be manifest, along with savings to the Medicare program.  Smoking is the number one cause of preventable deaths in the United States.  HHS' press release has more details; the CMS background study and recommendations are here.

Could this mean that Medicare is finally committed to the idea that an ounce of prevention is worth a pound of cure?  Could this mean that Medicare coverage for physicals, prevention, and wellness visits for seniors could be far behind?  Stay tuned . . . .  [tm]

December 24, 2004 | Permalink | Comments (0)

How Not to Lobby for MedMal Reform

Law.com has an interesting article on a hospital's efforts to lobby for tort reform and some privacy problems that arose.  A doctor's group that videotaped a woman's emergency room visit as part of a tort reform informational ad has been sued by the now-deceased woman's relatives who are alleging a violation of privacy.

I am surprised that the hospital and the doctors didn't run this informational ad idea by their lawyers - with the enactment of HIPAA - you would think that someone would vet the idea and final ad for potential for privacy violations.

[bm]

December 24, 2004 | Permalink | Comments (0)

Best Legal Blogs

Robert Ambrogi of Legal Technology  News and the author of "The Essential Guide to the Best (and Worst) Legal Sites on the Web," has put together a list of terrific legal blogs.   Although many of the websites provide practical advice to lawyers, some are wonderful resources to anyone interested in the law and learning more about our legal system.

[bm]

December 24, 2004 | Permalink | Comments (0)

Thursday, December 23, 2004

Cloning and Human Identity: "A Number"

Number184 Caryl Churchill's play, "A Number," is creating a lot of buzz these days.  It's playing off Broadway with Sam Shepard in the lead, and has prompted two solid reviews from The New York Times (Mel Gussow, Ben Brantley) and an essay on bioethics and art by Benedicta Cipolla (NPR web site).  Here's some of the Brantley review:

Even the title makes you dizzy when you think about it, in the way that staring at printed words causes them to wriggle and blur. ''A Number,'' to be exact (or inexact), is the name of Caryl Churchill's stunning new play, which opened last night at the New York Theater Workshop. And a number is something definite and specific, right? As in pick a number from 1 to 10?

Sorry, but that's not what Ms. Churchill has in mind, or at least not the only thing she has in mind. ''A number'' is also the first line of this latest drama from the ferociously inventive Ms. Churchill that stars Sam Shepard (who is terrific in his first New York stage appearance in more than 30 years) as a guilt-hobbled father and Dallas Roberts as his son.

Uh, make that sons. Because ''a number,'' in this instance, refers to an indeterminable quantity -- more than one, maybe 20, maybe more -- of the versions of Mr. Roberts's character who are roaming the earth.

"A Number," you see, is a gripping dramatic consideration of what happens to autonomous identity in a world where people can be cloned. The invaluable Ms. Churchill has not begun to stop surprising and unbalancing theatergoers. Since the 1970's this British dramatist has produced studies of a world quaking under constant siege in which style somehow always uniquely mirrors content. She has pondered mutations in gender (''Cloud Nine'') and language (''Blue Heart''), as well as the seismic disruptions of revolution (''Mad Forest''), civil war (''Far Away'') and environmental poisoning (''The Skriker'').

She has now moved on to ponder a threat to the very cornerstone of Western civilization since the Renaissance: the idea of human individuality, a subject she manages to probe in depth in a mere hour of spartan sentences and silences. It is hard to think of another contemporary playwright who combines such economy of means and breadth of imagination.

Every word, gesture and pause in this dramatic fugue for two actors, meticulously directed by James Macdonald, sets off echoes of multiple meaning. The play trenchantly makes the point that we no longer have the apparatus, verbal or psychological, to accommodate the changes in a time when science is moving faster than society. There's a reason that the men in ''A Number'' seem to speak in shards. Inarticulateness has become the only fitting form of eloquence.

The arrival in New York of ''A Number,'' which was produced at the Royal Court Theater in London two years ago, is a great event. . . .

Number185_1

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December 23, 2004 | Permalink | Comments (0)

When Good Things Happen to Good People

When an academic health lawyer with a specialty in bioethics sells books in the millions and is translated into a few score languages around the world, one's first reaction might be joy (and a private sense that if it can happen to one of us, it could happen to me) or it might be trepidation ("Oh, no, not another Luddite reworking of Frankenstein"). 

In the case of Alexander McCall Smith -- late of the University of Edinburgh and an occasional visitor on the law faculty at SMU -- joy would be the appropriate response.  Sandy is one of those rarities in life: a self-effacing polymath, a person of boundless energy and cheer who takes nothing (least of all himself) too seriously.  He is also the internationally best-selling author of the The Ladies No. 1 Detective Agency and its five (so far) sequels.  Plus the first in a new mystery series set in Scotland, The Sunday Philosophy Club. And don't forget the collections of stories such as Portuguese Irregular Verbs or the best-selling children's books in the UK, at least before he was eclipsed by another Edinburgher. He is also one of the founders (and chief bassoonist) of Edinburgh's Really Terrible Orchestra.  I have sat in with the RTO in rehearsal (on a truly sweet-sounding clarinet cobbled together from three so-so instruments in Sandy's personal collection) and the RTO richly deserves its name (though, to his credit, Sandy's bassoon-playing does not seem to be dragging them down; in fact, no one in the orchestra remembers ever hearing him play a single note on the thing).

If you haven't run across Alexander McCall Smith or his fictional creations, this holiday break would be a good time to learn more about him (starting with this profile in the Dec. 23 Macleans) and to pick up one of his books. 

December 23, 2004 | Permalink | Comments (0)

Survival Myth Debunked

An article in JAMA this week dispells one of the myths of this holiday season.  Many have argued that cancer patients "will" themselves to live through the holidays or their birthday.  Studying individuals with cancer in Ohio, the JAMA article reports that no evidence exists that cancer patients survive during times of religious, social or personal importance. 

December 23, 2004 | Permalink | Comments (0)

South Caroline Rejects Wrongful Life Claim

A unanimous South Carolina Supreme Court rejected a lawsuit brought by a woman who claimed that she was denied the option to abort her severely disabled son because her physician failed to tell her about the condition.  The lawsuit was filed by Jennie Willis on behalf of her now 8-year-old son, Thomas, who was born without a large portion of his brain.  Although the court recognized the serious nature of Thomas' disability, it did not accept the "wrongful life" claim stating, "Even a jury collectively imbued with the wisdom of Solomon would be unable to weigh the fact of being born with a defective condition against the fact of not being born at all."

Currently twenty-seven (27) other states either reject or limit the "wrongful life" claim, according to the court.  California, Washington and New Jersey are the only states that allow such claims; and the remaining states haven't taken a position.

A brief story on the opinion is here and the full opinion is available here.

December 23, 2004 | Permalink | Comments (0)

Wednesday, December 22, 2004

Drug Re-Importation and the AMA

At its interim meeting this December, the American Medical Association (AMA) for the first time offered its conditional support for prescription drug reimportantion.  Although expressing concern about patient safety, the AMA said that the ability of pharmacies and wholesalers to buy back drugs made in the United States from other nations provides a way to help lower prescription drug prices and increase the access to affordable care for many patients.  If such a buy-back system is put into the place, the AMA said that it must meet "rigorous safety requirements."  Some of those safety requirments include a closed distribution chain which allows the Food and Drug Administration (FDA) to vouch for the drugs' authencity and safety.  The AMA specifically rejected as a safe the practice of patients importing cheaper medications from internet pharmacies.   It is unclear what impact the AMA's conditional endorsement of drug re-importation will have on Congress when it considers related legislation next year.

Of course, the AMA's opinion may not matter, as a Presidential report makes it much less likely that such re-importation efforts will be pursued.  The New York Times and NPR have stories on the administration's review of the feasibility and cost savings of such drug re-importation efforts.  See Tom's post below for more information on the report.

[bm]

December 22, 2004 | Permalink | Comments (0)

Michael Moore to Take on Health Care Industry

Some invovled in the health care business are bracing themselves as Michael Moore's newest venture appears to target their industry.  As the Detriot News Health reports,

"America's pharmaceutical industry is putting out an advisory about the latest potential threat to its health: Michael Moore.

Moore, the filmmaker whose targets have included General Motors ("Roger & Me"), the gun lobby (the Oscar-winning "Bowling for Columbine") and President Bush ("Fahrenheit 9/11"), has now set his sights on the healthcare industry, including insurance companies, HMOs, the Food and Drug Administration -- and drug companies.

At least six of the nation's largest companies already have issued internal notices to their work forces, preparing them for potential ambushes."

Should be interesting . . . .

[bm]

December 22, 2004 | Permalink | Comments (1)

$395 Million to Settle Health Fraud Claims

Tenet_logo_5_1 As reported in the Wall Street Journal and Reuters:

Tenet Healthcare Corp. agreed to pay $395 million to settle most of the litigation brought by patients who claimed to have undergone unnecessary cardiac procedures at one of its hospitals.

Tenet, one of the nation's largest hospital operators, said it will establish a fund to be allocated among more than 750 patients who brought individual civil suits against the company related to heart surgeries and other invasive procedures performed from 1992 through 2002 at its former hospital in Redding, Calif. The allegations surfaced two years ago and provoked a national outcry that tarnished Tenet's reputation and led to sale of the hospital.

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December 22, 2004 | Permalink | Comments (0)

Drug Importation: HHS Report

Hhs The HHS Task Force on Drug Reimportation has issued its "Report on Prescription Drug Reimportation" (PDF).  Its findings are not terribly surprising:

  1. The current system of drug regulation in the U.S. has been very effective in protecting public safety, but is facing new threats. It should be modified only with great care to ensure continued high standards of safety and effectiveness of the U.S. drug supply.
  2. There are significant risks associated with the way individuals are currently
    importing drugs.
  3. It would be extraordinarily difficult and costly for “personal” importation to be
    implemented in a way that ensures the safety and effectiveness of the imported
    drugs.
  4. Overall national savings from legalized commercial importation will likely be a
    small percentage of total drug spending and developing and implementing such a program would incur significant costs and require significant additional authorities.
  5. The public expectation that most imported drugs are less expensive than American drugs is not generally true.
  6. Legalized importation will likely adversely affect the future development of
    new drugs for American consumers.
  7. The effects of legalized importation on intellectual property rights are uncertain
    but likely to be significant.
  8. Legalized importation raises liability concerns for consumers, manufacturers,
    distributors, pharmacies, and other entities.

Robert Pear has the story in the Wednesday N.Y. Times: "Administration Gives Mixed View on Drug Imports," with the following key points:

The Bush administration said Tuesday that commercial importation of some low-cost prescription drugs from Canada might be feasible. But the savings to consumers would be small, it said, and the federal government would have to spend hundreds of million dollars a year to ensure the drugs' safety.

The administration said in a report to Congress that legalizing imports would probably hurt the development of new drugs for Americans.

The report was released amid growing support for laws on importing drugs. Republican proponents include Senators Olympia J. Snowe of Maine, John McCain of Arizona and Trent Lott of Mississippi; Gov. Tim Pawlenty of Minnesota; and Representative Jo Ann Emerson of Missouri, as well as several newly elected members of Congress.

Sponsors of bills to legalize drug imports said they would keep pushing for it in the new Congress.

"I never had much confidence that this study was going to be objective," said the sponsor of one bill, Senator Byron L. Dorgan, Democrat of North Dakota.

Ms. Snowe said the administration had "failed to provide any meaningful recommendations" to Congress.

The conclusions of the report are generally consistent with studies by the drug industry, the Food and Drug Administration, and the Congressional Budget Office. Many economists and health care experts say importing drugs from countries that control their prices would do little to solve the problem of expensive drugs here.

On the other hand, consumer groups like AARP and some drugstore executives, including the chairman of CVS, have said commercial imports would be much safer than the current flood of largely unregulated imports by individuals.

[tm]

December 22, 2004 | Permalink | Comments (0)

Tuesday, December 21, 2004

Cincinnati Seeks New Dean

Logo of Univ of Cincinnati College of LawThe University of Cincinnati College of Law is seeking a new dean. For more information, see the College of Law's dean search web page:

 

Nominations, expressions of interest, and requests for the comprehensive position description should be emailed to the Witt/Kieffer executive search firm here

December 21, 2004 | Permalink | Comments (0)

American Tort Reform Award

Just to make sure that equal time is provided to all viewpoints, new awards for those who favor tort reform have been announced.  The American Tort Reform Association has released its 2004 Judicial Hellholes awards.  It is quite a different list and perspective than found at the Zany Immunity Awards.  The list identifies those courts that the ATRA believes to "deny equal justice under the law."

[bm]

December 21, 2004 | Permalink | Comments (1)

Times x 2

Two articles of note in today's New York Times:

  1. APills_1n op-ed piece by Merrill Goozner ("Overdosed and Oversold") that argues for:
    1. an independent arm of F.D.A. that contracts with independent clinicians and scientists for the final testing of all new drugs and medical devices. After a company submits its drug application based on safety and early efficacy trials, this arm would design the protocols to learn not just if the new drug is effective versus a placebo, but how it compares to other therapies and how it can be most effectively used. At the same time, the F.D.A. agency would need an adequately financed post-marketing system that would follow through on a drug's safety, using information and financing independent of the drug manufacturers. It should also reimpose the pre-1997 restrictions on direct advertising to consumers, one of the elements that led to vast popularity of Celebrex and Vioxx among arthritis patients.

      Congress should also set up an independent agency for conducting comparative trials for thousands of existing therapies. This new center, perhaps housed at the National Institutes of Health, would also evaluate the cost-effectiveness of new technologies and finance the work of scientists who want to test older, off-patent medicines for new uses. And it could oversee the creation and updating of clinical practice guidelines free from commercial sponsorship so that hospitals and doctors can base their decisions on objective evidence.
  2. Lawrence K. Altman ("The Ultimate Gift: 50 Years of Organ Transplants") commemorates the 50th anniversary of "the first 21transplant2_1 successful organ transplant, a kidney transplant from a living donor performed in Boston in 1954."  Now,

surgeons have learned how to transplant virtually every vital organ in the human body. They have also branched out to transplant an array of nonvital body parts including, most recently, the hand. In the near future, face transplants, still a subject of controversy, are likely to become a reality: last month, the Cleveland Clinic became the first institution to receive approval for the operation.

The patient stories include Robert Phillips, who received his sister's kidney in 1963 and is the world's longest organ transplant survivor.  Altman discusses the controversy swirling around a proposal to do facial transplantation and some of the ideas proposed to deal with chronic shortages of organs, but little or nothing about the growing debate over whether transplantation represents a serious misallocation of medical resources that could be better spent on primary and preventative health care services.

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December 21, 2004 | Permalink | Comments (0)

Access to Care for Minorities

The Washington Post has an article today that discussses a recent study in the American Journal of Public Health which emphasizes the need for better access to basic medical care for minority Americans.  The Post article details the rather shocking statistic that "[m]ore than 886,000 deaths could have been prevented from 1991 to 2000 if African Americans had received the same care as whites."

According to the study, it is not only that many African Americans lack access to health care but also that factors such as education, enivornment and income play an important role in preventing disease and death.  The authors of the study stated that the challenge facing the U.S. health system is to provide the same quality health care to everyone, despite these factors.   

December 21, 2004 | Permalink | Comments (0)

Slate Covers "Babies By Design" Conference

Slate's William Saletan filed a story on last week's conference, "Babies by Design," sponsored by the Genetics and Public Policy Center, which reviewed some of the more promising techno-advances on the horizon of genetic therapy (and enhancement).  Saletan's article focuses on genetic policy and who will get to make it in the coming years.  The juxtaposition of politicians, the press, and the public makes for interesting reading.  [tm]

December 21, 2004 | Permalink | Comments (0)

Monday, December 20, 2004

Top Immunity Awards

Indiselogo1 In response to the recent calls for tort reform, the Center for Justice and Democracy has released its Top Ten Zany Immunity Awards. The list includes a variety of state laws that provide protection from law suits to people such as funeral home operators who put someone else's body parts in your relative's coffin and tanning parlor operators who tire of warning people not to bake themselves.  The list makes interesting, and sometimes, humorous reading.   The Center for Justice and Democracy website contains other information that those who are teaching Health Law or Torts may find helpful in stimulating debate over the best way to control the costs of health care and prevent injuries.

Perhaps the AMA needs to add this website to its reading list.

[bm]

December 20, 2004 | Permalink | Comments (1)

Tort Reform AMA's Top Priority

The American Medical Association (AMA) remains strongly committed to tort reform and sees such reform as its number one priority.  At the AMA's interim meeting in December, the AMA emphasized its ongoing support for and effort to pass federal tort reform that includes a $250,000 cap on noneconomic damages in medical liability cases. The reform has passed the House but failed to pass the Senate in this session.

Another hot topic was reining in medical expert witnesses.  Doctors attending the meeting suggested that toughened medical expert witness standards were necessary and began to set strict standards as to which colleagues they believe should be allowed to testify in court.  They also stated that they wanted state courts to adopt expert witness policies similar to those followed at the federal level, including full and timely disclosure of expert witnesses' opinions, reports, qualifications, compensation and prior cases in which they've testified.

As the AMA News reports, the physicians set forth some minimum standards for expert witnesses, including the following: 

  • Comparable education, training and occupational experience in the same field as the defendant doctor or specialty expertise in the disease or the process performed in the case.
  • Active educational practice or teaching experience in the same field as the defendant physician.
  • Current experience within five years of the action that initiated the lawsuit.
  • Certification by a board that the American Board of Medical Specialties or the American Osteopathic Assn. recognizes or by a board with equivalent standards.

There was a split on the necessity of the expert witness to be board certified.  Some doctors expressed the view that board certification was important to them but others said that board certification doesn't guarantee "honest testimony." 

[bm]

December 20, 2004 | Permalink | Comments (0)

Nonprofit Hospitals in the Cross-hairs

Yesterday The New York Times Magazine ran a piece by Jonathan Cohn ("Uncharitable?") on the controversy swirling around the billing and collection practices of nonprofit, tax-exempt hospitals.  It is predictably long on horror stories, but it does attempt to provide some context, if not exactly balance, in describing how the uninsured are handled by The System.  [tm]

December 20, 2004 | Permalink | Comments (0)

Sunday, December 19, 2004

FDA Problems

Both the Washington Post and New York Times have stories today concerning various problems at the FDA and its ability (or inability) to protect the public from drugs after they are already on the market.  The Post reports on the lack of senior leaders at the FDA.  The article argues that this lack of stable leadership has left the agency in a weak position so that it is more easily influenced by drug manufacturers and also unable to respond to emerging problems quickly and efficiently.

The New York Times runs a story concerning big drugs and big marketing, focusing on the difficulties that the FDA has when it attempts to regulate and monitor drugs after they have won agency approval.  The article spoltlights the COX-2 drugs which have recently been found to cause heart problems.

Both articles provide a helpful overview of the FDA's current procedures and also a good summary of the recent problems over the COX-2 drugs.

[bm]

December 19, 2004 | Permalink | Comments (0)