Thursday, September 14, 2006

Latest from the law reviews

From the Marian Gallagher Law Library at the University of Washington:

FOOD AND DRUG
  • Hareid, Jonathan A. Comment. Testing drugs and testing limits: Merck KGaA v. Integra Lifesciences I, Ltd. and the scope of the Hatch-Waxman safe harbor provision. (Merck KGaA v. Integra Lifesciences I. Ltd. [Integra II], 125 S. Ct. 2372, 2005.) 7 Minn. J.L. Sci. & Tech. 713-756 (2006). [L][W]
  • Ma, Jonathan. Note. Lowering prescription drug prices in the United States: are reimportation and Internet pharmacies the answer? 15 S. Cal. Interdisc. L.J. 345-375 (2006). [L][W]
  • Pisut, Patcharin. Recent development. Freedom to research: room for trial and error in drug development after ... (Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372, 2005.) 2005 U. Ill. J.L. Tech. & Pol'y 339-355. [L][W]
  • Politis, Pamela D. Student article. Transition from the carrot to the stick: the evolution of pharmaceutical regulations concerning pediatric drug testing. 12 Widener L. Rev. 271-291 (2005). [L][W]
  • Vokes, Sarah J. Student article. Just fill the prescription: why Illinois' emergency rule appropriately resolves the tension between religion and contraception in the pharmacy context. 24 Law & Ineq. 399-420 (2006). [L][W]
HEALTH LAW AND POLICY
  • Greeley, Henry T. Neuroethics and ELSI: similarities and differences. 7 Minn. J.L. Sci. & Tech. 599-637 (2006). [L][W]
  • Melden, Michele. Guarding against the high risk of high deductible health plans: a proposal for regulatory protections. 18 Loy. Consumer L. Rev. 403-433 (2006). [L][W]
  • Nicosia, Joseph III. Student article. Avian flu: the consumer costs of preparing for global pandemic. 18 Loy. Consumer L. Rev. 479-501 (2006). [L][W]
  • Su, Brian. Comment. Developing biobanking policy with an Oliver Twist: addressing the needs of orphan and neglected diseases. 66 La. L. Rev. 771-808 (2006). [L][W]
  • Regulating for Patient Safety: The Law's Response to Medical Errors. Foreword by Barry R. Furrow; articles by Barry R. Furrow, Stanton N. Smullens, M.D., Adam S. Evans, David B. Nash, M.D., John D. Blum, Bryan A. Liang, M.D., William M. Sage, M.D., David A. Hyman, Charles M. Silver, Nicholas P. Terry, Robert B Leflar, Futoshi Iwata, Marshall B. Kapp, Darlene Ghavimi, Pamela D. Politis, Maggie M. Finkelstein and James W. Saxton. 12 Widener L. Rev. 1-325 (2005). [L][W]
MEDICAL JURISPRUDENCE
  • Gonzalez, Jarod S. A matter of life and death--why the ADA permits mandatory periodical medical examinations of "remote-location" employees. 66 La. L. Rev. 681-731 (2006). [L][W]
  • Upchurch, Angela K. The deep freeze: a critical examination of the resolution of frozen embryo disputes through the adversarial process. 33 Fla. St. U. L. Rev. 395-435 (2005). [L][W]

[L] = Lexis/Nexis link
[W] = WestLaw link
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Monday, September 11, 2006

Senate Finance Comm. hearings scheduled on nonprofit hospitals and community benefit

From AHLA's Tax and Finance Practice Group comes this e-mail alert:

To: Tax and Finance Practice Group Members
From: Linda S. Moroney, Chair; John B. Beard, Vice Chair, Membership; James R. King, Vice Chair, Educational Programs; Stephen P. Nash, Vice Chair, Publications; Thomas J. Schenkelberg, Vice Chair, Research
Date: September 8, 2006

Under the leadership of Chairman Chuck Grassley, the Senate Finance Committee has scheduled a new hearing regarding tax-exempt hospitals. Entitled "Taking the Pulse of Charitable Care and Community Benefits at Nonprofit Hospitals," the hearing is scheduled for September 13, 2006, at 10:00 a.m. in 215 Dirksen Senate Office Building [link]. The current slate of witnesses includes the Kansas Attorney General (who has opened up investigations of the billing and collection practices of nonprofit hospitals after complaints from consumers), an employee union representative, and a Legal Aid Society official; it is anticipated that the foregoing will relate certain "horror stories" from indigent individuals who either did not receive care or got involved in billing disputes over care with tax-exempt hospitals. Other witnesses are anticipated to present the hospital perspective, including leaders from the Catholic Health Association and the American Hospital Association, in addition to a rural hospital administrator.

Senator Grassley has for several years conducted an aggressive examination of the entire charitable sector, with increased scrutiny on tax-exempt hospitals. Grassley conducted his first hearing on tax-exempt organizations back in 2004 [link]with a primary focus on governance and best practices of charities [staff discussion draft]. In 2005, the Senate Finance Committee held a second hearing on the nonprofit sector [link] in which Grassley indicated that it was time for comprehensive reforms for charitable organizations. Following that hearing, Grassley sent letters to ten nonprofit hospitals asking forty-five questions about their charity care and communitybenefit, as well as compensation, billing and debt collection practices (press release and copy of letter]. In March 2006, as part of his continued examination of nonprofit hospitals and their tax-exempt status, Grassley sent letters to the American Hospital Association [link] and the Catholic Health Association [link] requesting information from those organizations on a variety of issues, including community benefit, charity care, and certain nonprofit hospital practices [related hearing]. In June of this year, Grassley sent letters to the Chief Counsel of the IRS and Commissioner for Tax Exempt and Governmental Entities, calling for increased scrutiny of the nonprofit sector, particularly tax-exempt hospitals [link]. In July, Grassley, at the nomination hearing for Eric Solomon (nominee for deputy Treasury secretary for tax policy), raised the issue of the current rules governing charitable hospitals and requested that Treasury and the IRS revise those rules. Grassley criticized the 1969 IRS rules that established the "community benefit standard" and asked Solomon to commit to a timetable for review and proposals for reform of those rules [link]. That same month, Grassley harshly criticized the lack of response by the hospitals selected by the GAO for its survey on executive compensation and questioned certain compensation practices of those hospitals that did respond to the survey [link].

This latest action to schedule a new Senate Finance Committee hearing and the witnesses selected to testify demonstrate that Grassley, perhaps due to his dissatisfaction with the overall response from the nonprofit hospital community to his inquiries, is looking to keep the heat on nonprofit hospitals and continue the debate on their tax-exempt status. Any thoughts that the remainder of this year would be relatively calm as far as congressional activity on nonprofit hospitals are now in doubt.

The AHLA Tax and Finance Practice Group would like to thank Don Stuart, Esq. (Waller Lansden Dortch & Davis, LLP, Nashville, TN) for providing us with this email alert.

Imagine how Sen. Grassley's blood boils when he reads stories like this (from the Boston Globe): "Hospital CEOs join the $1m club":
Chief executives at charitable hospitals in Massachusetts received substantial pay and benefit increases in fiscal year 2005, for the first time boosting their overall compensation to more than $1 million at most of the largest institutions.

Also, the highest-paid hospital executive in the state, Partners HealthCare chief executive James J. Mongan, broke the $2 million barrier, another significant milestone.
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Sunday, September 10, 2006

DEA and proposed controlled-substances rules

From the Federation of State Medical Board's weekly "BoardNet News" (Friday, September 8, 2006):

DEA Seeks Comment on New Proposed Controlled Substances Rules
The Drug Enforcement Administration (DEA) is seeking comment on a policy statement and a proposed rule regarding the issuance of multiple prescriptions. The documents, “Dispensing Controlled Substances for the Treatment of Pain” and “Issuance of Multiple Prescriptions for Schedule II Controlled Substances” were published on the Federal Register website on Sept. 6.

The documents are in response to more than 600 comments received by the DEA regarding its withdrawal of the August 2004 document, "Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel," and a subsequent interim policy statement issued in November 2004. State medical board comments were coordinated and submitted collectively by the FSMB in early 2005.

Under the DEA’s proposed rule change, the “Do Not Fill Until...” provision would allow physicians to write three separate prescriptions with staggered fill dates so patients can be given the equivalent of a 90-day prescription for schedule II controlled substances when medically appropriate.

The proposed rule addresses concerns voiced by medical boards and others regarding the DEA’s 2004 interim policy statement on issuance of multiple Schedule II prescriptions.

The policy document indicates that the DEA remains committed to a balanced approach policy; that it is outside the scope or authority of DEA to define or dictate the practice of medicine; and that the DEA’s authority does not supersede state medical board authority.
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Saturday, September 09, 2006

Latest from AHLA's Health Lawyers Weekly (8 Sep 2006)

From the table of contents of the Sept. 8 issue of AHLA's Health Lawyers Weekly, a free member benefit:

Top Stories
  • CMS Reports On Ongoing Improvement Of QIO Program
    The Quality Improvement Organization (QIO) Program is an essential component of initiatives in transparency and performance-based payment of providers, the Centers for Medicare and Medicaid Services (CMS) said in an August 31 report to Congress, Improving the Medicare Quality Improvement Organization Program--Response to the Institute of Medicine Study. Full Story
  • CMS Announces Physician-Hospital Gainsharing Demonstration Project
    The Centers for Medicare and Medicaid Services (CMS) announced September 6 the launch of its Physician-Hospital Collaboration Demonstration (PHCD), a three-year demonstration program to examine whether allowing hospitals to provide financial incentives for physicians to support better care can improve patient outcomes without increasing costs. Full Story

Articles & Analyses

Current Topics

(c) 2006, AHLA. Reprinted with permission

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Friday, September 08, 2006

New article documents higher brain activity in vegetative patient

The N.Y. Times reports today that the journal Science has published an article [abstract; pdf (requires subscription)] in which British researchers performed a functional MRI (fMRI) scan on a post-traumatic-brain-injury patient diagnosed to be in a vegetative state and got back scans that would be indistinguishable from results obtained from subjects without brain injury. According to the Times article:
A severely brain-damaged woman in an unresponsive, vegetative state showed clear signs on brain imaging tests that she was aware of herself and her surroundings, researchers are reporting today, in a finding that could have far-reaching consequences for how unconscious patients are cared for and how their conditions are diagnosed.

In response to commands, the patientÂ’s brain flared with activity, lighting the same language and movement-planning regions that are active when healthy people hear the commands. Previous studies had found similar activity in partly conscious patients, who occasionally respond to commands, but never before in someone who was totally unresponsive.

If the researchers' report is accurate, the patient may have met all clinical criteria for vegetative state but she didn't meet two criteria in the standarddefinitionn of vegetative state: "no evidence of awareness of self orenvironmentt and an inability to interact with others" and "no evidence of sustained, reproducible, purposeful, or voluntary behavioral responses to visual, auditory, tactile, or noxious stimuli."

Does this change anything we know about the vegetative state? Does this suggest there may be a need to redefine what we mean by vegetative state? I don't think so.

First, this is a report of a single patient. She may be the only brain-injured patient in the world with these results. Time will tell.

Second, it's possible that over 5 months' time her condition changed from vegetative to something between vegetative and the "minimally conscious state" -- that is, she's no longer vegetative despite outward ("clinical") signs that she is. Should this be a cause for concern that we are routinely misdiagnosing patients as vegetative when they're not? Not necessarily.

As best I can tell from the full text of the article, the fMRI test was performed 5 months after the traumatic brain injury occurred in July 2005. That's long enough to confirm a diagnosis of vegetative state, and even long enough to confirm a diagnosis of persistent vegetative state, but it's a good 7 months shy of the American Academy of Neurology's practice parameter's recommendation of 12 months to confirm a diagnosis of permanent vegetative state after traumatic brain injury.

If the patient continues to meet the clinical criteria for the vegetative state 12 months after her traumatic brain injury and the researchers can show evidence (in the words of their report) "which confirm[s] beyond any doubt that she was consciously aware of herself and her surroundings," that will be an impressive result, although still not enough all by itself to justify altering our present diagnostic criteria.

Meanwhile, I expect this report will be used by partisans in the Schiavo debate to "prove" they were right about Terri Schiavo's mental status, despite irrefutable post-mortem evidence that her brain had atrophied more than 50% over the 15-year course of her vegetative state. Science warned against such a misuse of this report in its press release yesterday, according to the Times: "Science . . . added a 'special note' citing the Schiavo case and warning that the finding 'should not be used to generalize about all other patients in a vegetative state, particularly since each case may involve a different type of injury.'"
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Wednesday, September 06, 2006

Health law positions at Georgia State

Georgia State is looking for a couple of good public-health law profs:

Georgia State University’s College of Law seeks highly qualified applicants for three or more full-time faculty positions beginning with the 2007-2008 academic year.

Areas of special interest include criminal law and procedure, and it is anticipated that a successful candidate would be hired at the rank of assistant or associate professor. Two faculty positions are in areas related to public health law, and it is anticipated that one of these positions would be at the assistant or associate professor rank, and the other would preferably be at the full professor rank. For all positions, rank is commensurate with experience. Applicants should have an excellent academic background, strong experience in the focus area applied for, and a proven record of (or demonstrated potential for) successful teaching, scholarship, and service.

The ideal candidates for the two positions in public health law will have strong interdisciplinary research and teaching interests and be able to collaborate actively with the Center for Law, Health & Society at the College of Law and with the Institute of Public Health in the College of Health and Human Sciences at Georgia State University in the Partnership for Urban Health Research (see http://urbanhealth.gsu.edu/).

Part of a comprehensive research university, the College of Law is a dynamic urban-centered law school located in the heart of Atlanta with approximately 650 full- and part-time law students. We encourage applications from candidates who would diversify our faculty. Georgia State University, a unit of the University System of Georgia, is an equal opportunity educational institution and an equal opportunity/affirmative action employer.

Applications and nominations should be submitted to:

Professor Charity Scott
Chair, Faculty Recruitment Committee
Director, Center for Law, Health & Society College of Law
Georgia State University
P.O. Box 4037
Atlanta, GA 30302-4037

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Tuesday, September 05, 2006

SSRN roundup: health law (August 2006 additions)

Here are last month's postings to the ever-useful SSRN:

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Monday, September 04, 2006

Krugman: Why is health policy malpractice a conservative disease?

You can't read today's (or any day's) op-ed piece by Paul Krugman (or any other columnist in the N.Y. Times) unless you are a TimesSelect subscriber, so this link to his column, "Health Policy Malpractice") won't work for many of you. More's the pity. He compares the VA health care system (which by most measures appears to be working well -- excellent outcomes, low costs per patient) with Medicare Advantage (the managed-care plan that is a sufficient disaster that it can keep private insurers involved only by providing billions in subsidies).

What explains the VA's success? Here's Krugman's version:

The key to the V.A.’s success is its long-term relationship with its clients: veterans, once in the V.A. system, normally stay in it for life.

This means that the V.A. can easily keep track of a patient’s medical history, allowing it to make much better use of information technology than other health care providers. Unlike all but a few doctors in the private sector, V.A. doctors have instant access to patients’ medical records via a systemwide network, which reduces both costs and medical errors.

The long-term relationship with patients also lets the V.A. save money by investing heavily in preventive medicine, an area in which the private sector — which makes money by treating the sick, not by keeping people healthy — has shown little interest.

The result is a system that achieves higher customer satisfaction than the private sector, higher quality of care by a number of measures and lower mortality rates — at much lower cost per patient.


You might think that the government would be happy to see more veterans receive more of their care within the VA system, but you'd be wrong:

Not surprisingly, hundreds of thousands of veterans have switched from private physicians to the V.A. The commander of the American Legion has proposed letting elderly vets spend their Medicare benefits at V.A. facilities, which would lead to better medical care and large government savings.

Instead, the Bush administration has restricted access to the V.A. system, limiting it to poor vets or those with service-related injuries. And as for allowing elderly vets to get better, cheaper health care: “Conservatives,” writes Time, “fear such an arrangement would be a Trojan horse, setting up an even larger national health-care program and taking more business from the private sector.”

The irony isn't lost on Krugman: "Think about that: they won’t let vets on Medicare buy into the V.A. system, not because they believe this policy initiative would fail, but because they’re afraid it would succeed."

Meanwhile, the subsidies to lure private insurers into the Medicare managed care market push the costs to the government 11 percent higher than traditional Medicare and mortality rates are 40 percent higher than those of elderly veterans in the VA system. Krugman's conclusion:

On one side, then, the administration and its allies in Congress oppose expanding the best health care system in America, even though that expansion would save taxpayer dollars, because they’re afraid that allowing a successful government program to expand would undermine their antigovernment crusade and displease powerful business lobbies.

On the other side, ideology and fealty to interest groups make them willing to waste billions subsidizing private H.M.O.’s.

I don't really have a quarrel with Krugman's argument. Okay, maybe a nit to pick here or there (for example, the better comparison of costs-per-patient would have been between Medicare managed care, on the one hand, and the VA on the other -- Krugman implies that the VA's costs are lower than Medicare managed care, but he never actually says it. And research schlub that I am, I don't know where to go to get that missing piece of his argument.)

Also, I know it's dangerous to try to make policy on the basis of anecdote, but every medical student I know who rotates through the VA hospital here in Dallas comes back with horror stories of poor care (with respect to the technical component, the interpersonal component, and the amenities). It's just one hospital in a vast system, and the examples of bad care are likely to make more of an impression than the virtually silent and invisible examples of care that is provided well, but everyone I know rolls their eyes at the mention of the VA hospital. And yet, the VA stats speak for themselves, don't they?
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Sunday, September 03, 2006

Post-grad opportunity at Harvard

From I. Glenn Cohen, a fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (Harvard Law School):

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School

2007-2009 Post-Graduate and Mid-Career Fellowship Program

Call for Applications: Deadline October 16, 2006

The Petrie-Flom Center is an interdisciplinary research program at HarvardLaw School dedicated to the scholarly research of important issues about the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research, and bioethics.

The Center is now accepting applications for its second group of post-graduate/mid-career fellowships starting in August 2007. These are two-year full-time academic research fellowships paying $60,000 per year, plus benefits.

Applicants must hold a degree in law or some other graduate discipline that they intend to apply to issues of health law policy or 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 cutting-edge scholarship in the areas of health policy, biotechnology or bioethics during the term of the fellowship.

Fellows chosen for the 2007-09 term will join an outstanding inaugural group of fellows who started in August 2006, as well as senior fellow Frances Kamm, one of the world's leading moral philosophers, who will be in residence at the Center during the 2007-08 academic year. Detailed information about the fellowship program, our
current fellows, and how to apply is available at
www.law.harvard.edu/programs/petrie-flom/.

Applications are due no later than October 16, 2006. Please note that this deadline is several months earlier than last year's.


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Will Christian Science health plan count in Massachusetts?

As recently reported by the AP (courtesy of the Portsmouth (NH) Herald), health care regulators in Massachusetts are beset by a bevy of difficult issues in the wake of the Bay State's passage of a universal health care law:

When Gov. Mitt Romney signed the Massachusetts' health care law in April, it was hailed as a watershed moment.

Under the new law, Massachusetts is the first state to require all residents to have health insurance by July 2007.

The poorest will receive subsidized care, while everyone making more than three times the federal poverty level will be required to have private insurance, either through their employer or on their own.

To encourage employers to offer insurance, the law imposes an annual $295 per-worker fee on employers that don't offer insurance but employ 11 or more workers.

Christian Scientists want to make sure the new regulations recognize the church's own health plan, based on spiritual healing instead of medications and surgery, as a legitimate health care plan both for employers and individuals. . . .

[Jane Warmack, head of the church's legislative division] said the church wants to make sure other health care plans that don't rely on invasive medical care are put on an equal legal footing with other insurance plans.

"The legislative intent behind the law was to ensure that Massachusetts residents would be provided health care," she said. "It wasn't to dictate a particular kind of health care."

She said she also wanted to make sure that individuals who opt for alternative plans would not be penalized.

"What's at stake is people's access to the type of health care they want and for some people that is spiritual healing," she said.

The church already has testified before the state Division of Health Care Finance and Policy, which will write the final regulations. Those are expected sometime in early September, according to Dick Powers, spokesman for the Executive Office of Health and Human Services.

"We listened and read everyone's testimony and all of it will be taken into consideration," Powers said.

Powers also pointed to a portion of the law that would allow individuals to avoid tax penalties if they file an affidavit with their income tax returns stating "sincerely held religious beliefs" were the basis of their refusal to obtain "creditable coverage."

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AHLA's Health Lawyers Weekly (Sept. 1)

Here's the table of contents from Friday's "Health Lawyers Weekly," a free member benefit from the American Health Lawyers Association (and reprinted here with their permission):

September 1, 2006 Vol. 4, Issue 34
Top Stories
  • Specialty Hospitals Associated With Increased Utilization, MedPAC Finds
    Physician-owned heart hospitals are associated with a significant increase in the rate of cardiac surgeries in the market where the hospital is located, according to a Medicare Payment Advisory Commission (MedPAC) 2006 Report to Congress, Physician Owned Specialty Hospitals Revisited. According to the report, the entrance of a physician-owned cardiac hospital into a market was associated with a 6% increase in the number of cardiac surgeries per 1,000 Medicare beneficiaries. Full Story
  • Schering-Plough Will Pay $435 Million To Settle Allegations Of Illegal Marketing, Fraud
    Schering-Plough Corp. and one of its subsidiaries have agreed to a $435 million global settlement to resolve criminal charges and civil claims that they engaged in illegal sales and marketing schemes and defrauded Medicaid, U.S. Attorney for the District of Massachusetts Michael Sullivan announced August 29.The settlement stems from allegations that the company marketed its drug Temodar and Intron A for so-called "off label" uses that had not been approved by the Food and Drug Administration (FDA). Full Story

Articles & Analyses

Current Topics

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U.S. research: running on empty?

Today's N.Y. Times has a piece ("The State of Research Isn't All That Grand") discusses the implications for the U.S. economy of reduced R&D expenditures in both the public and private sectors. The balanced conclusion:

In global R.& D. rankings, the United States is still the clear leader in spending, with 34 percent of the total. In fact, about half of all such spending comes from just two nations: the United States and Japan.

But the United States falls down the list when it comes to more meaningful comparisons.

According to the Organization for Economic Cooperation and Development, the nation ranks seventh in R.& D. spending as a share of the economy, trailing Sweden, Finland, Japan, Switzerland, Iceland and South Korea. In spending on basic research as a share of R.& D., the United States ranks 11th. And when measuring nondefense research as a share of the economy, it’s 22nd.

Looking ahead, there is good reason to expect even greater pressure on R.& D spending in the United States. The federal government will be only more constrained in its ability to invest in research as large unfunded commitments like Social Security and Medicare come due. Corporate America will continue to face competitive global pressures, seeking investments that pay off in the short term. And fast-developing countries like China and India will strive to become even more powerful global forces.

It all leads to a question: Where will the innovation come from to drive the American economy of the future?

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Tuesday, August 29, 2006

"Medically inappropriate treatment" - how do we decide?

There's a good piece in the NY Times today about dialysis, when and how it should be withheld, and who should decide: "Choosing a 'God Squad,' When the Mind Has Faded" by Barron Lerner, MD. Here's how it starts:
Would you want your tax dollars to pay for dialysis for a patient with irreversible brain damage? In 1972, when Congress agreed to use Medicare money to finance dialysis for patients with end-stage kidney failure, this question had never come up.

But now, new research shows, many patients on dialysis have severe mental impairment. Is it appropriate, or even possible, to refuse to give patients this treatment?

The article mentions Medicare's End-Stage Renal Dialysis program, which covers dialysis for all who are medically qualified to receive it; the article then takes a trip down the resource-allocation highway, followed by an abrupt turn down a more patient-centered boulevard:

But there were new problems. For one, the bill’s sponsors underestimated the demand for dialysis, now given to more than 300,000 patients a year, at a cost of more than $16 billion. It also became clear that the technology was, in some cases, being used indiscriminately.

In 2000, Dr. Alvin H. Moss, director of the Center for Health Ethics and Law at West Virginia University, led a committee of the Renal Physicians Association and the American Society of Nephrology that developed guidelines on the use of dialysis. It was found to be inappropriate for those with “irreversible, profound neurological impairment,” among others. The committee also said it was reasonable to consider withholding dialysis from patients with terminal illnesses unrelated to the kidneys. . . .

“The renal-care team has the right to refuse to offer dialysis when the expected benefits do not justify the risks,” Dr. Moss said. At his home institution, Dr. Moss is taking a more hard-line approach, saying no to families who request what he believes is inappropriate dialysis. At other times, he offers the dialysis, but if the patient doesn’t improve, it is stopped.

So far he has not been sued, he said, citing thoughtful discussions he has had with family members about what dialysis can and cannot achieve.

But the fear of lawsuits continues to worry many nephrologists who believe that it is safer to provide dialysis. And there remains that old American unwillingness to let people die, even when it is surely their time.

Dr. Valeri, of Columbia, knows this feeling well. If he suggests to relatives that dialysis be withheld for a gravely ill family member, they confuse it with euthanasia. “They think you are just another Kevorkian,” he said.

In a microcosm, this is exactly the discussion we've been having in Texas this year, as we debate the merits of Texas' so-called "futility law," which allows hospitals to stop life-sustaining treatment when a physician says the treatment is not appropriate and an ethics committee agrees (§ 166.046 of the Health & Safety Code). Are there limits beyond which otherwise appropriate care becomes inappropriate? What is the source of those limits: benefits/burdens ratio for the patient? benefits/burdens for society? a professional ethos among nephrologists (pulmonologists, cardiologists, intensivists, et al.)? Is the threat of litigation a good thing or a bad thing? What do we mean by good end-of-life care? If the technological imperative is resisted, is that euthanasia or the wise practice of medicine?

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Friday, August 25, 2006

AHLA's Health Lawyers Weekly (Aug. 25)

Here's the table of contents from today's Health Lawyers Weekly, reprinted here with the kind permission of the AHLA:

Top Stories

Articles & Analyses

Current Topics

(c) 2006, AHLA. Reprinted with permission.

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OTC sales of Plan B approved for adults

After years of hassling over whether to approve over-the-counter sales of the Plan B contraceptives, the FDA has finally relented and announced yesterday that the "morning after" pill would become available for purchase by adults by the end of the year. (NY Times; Wall Street Journal; Washington Post; AP/MyWay) Compared to the original application three years ago, which sought approval for sales by under-18's as well, this is something of a compromise, and a disappointment to advocates for broader access. Much of the agency's foot-dragging was wrapped in official comments that questioned the adequacy of safety data for teenaged users, although critics of the agency believed the doubts were a smokescreen for the Bush administration, which appeared to opposed broadening the availability of this contraceptive on political grounds. Their bottom line -- on a number of issues -- seems to be that they are against anything that might make teen sex a little less dangerous and therefore a little more attractive: "Plan A (Abstinence) or the highway!" Could a government policy be more backward? At least yesterday's announcement is a start. Meanwhile, according to the AP, "[t]he Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue."
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Thursday, August 24, 2006

Why is 16% of GDP too much to spend on health care?

That will be one of my questions tomorrow in the first class in Health Law. I remember, back during the debate over the Clintons' plan, the tongue-in-cheek report that, at the then-current rate of health-care inflation, in 50 years 100% of our GDP would be health care ("every man, woman, and child would be in hospital beds administering IVs to one another"). Now, quite sensible people (e.g., Robert W. Fogel, a Nobel laureate at the University of Chicago's Graduate School of Business) predict that health care will account for 25% of GDP by 2030. It's less than 100%, but it's still the kind of number that makes you sit up and take notice.

It also made Gina Kolata sit up and take notice in Tuesday's New York Times. There is much to think about (and discuss in class) in this article, including this exchange:

Unless the current system is changed, most health care costs will continue to be paid by insurance, especially Medicare, which means that the taxpayers will foot the bill. But Dr. Fogel says he is not alarmed. Americans can afford it, he says, because the nation is so rich.

“It takes so little of household income to satisfy expenditures on food, clothing and shelter,” he explains. “At the end of the 19th century, food, clothing and shelter accounted for 80 percent of the family budget. Today it’s about a third.” Other economists agree. “We have to spend our money on something,” says Robert E. Hall, a Stanford University economist.
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Wednesday, August 23, 2006

New technique for deriving embryonic stem cells that doesn't destroy the embryo

You would think that a technique that allows lab techs to grow embryonic stem cell lines without destroying the embryo would be the ultimate answer to the principal objection to embryonic stem cell research. But you would be wrong.

An on-line letter (1st paragraph only) at the journal Nature (requires subscription) describes the technique, as do articles posted this afternoon to the web sites of the New York Times and the Wall Street Journal (requires subscription). Researchers at Advanced Cell Technology report success borrowing the technique used for pre-implantation genetic diagnosis ("PGD") of embryos created at in vitro fertilization centers. The technique takes the fertilized egg at the point that it is an 8-celled organism. The cells are called blastomeres, and PGD removes one blastomere for genetic testing and screening. Now 10 years old, PGD produces no discernible harm to the remaining 7-cell organism, which appears capable of developing into a normal, health embryo and then fetus. It was reported last year that embryonic stem cells were derived from mouse embryos using this technique. The ACT letter appears to be the first report that the technique can be successfully performed on human embryos. ACT's press release is here. More details are also available from the statement issued by ACT's ethics advisory board.

Despite the head-on challenge this technique represents to current ethical objections to harvesting embryonic stem cells, both papers report that the news was met with different degrees of skepticism, dismay, and downright hostility by the U.S. Conference of Catholic Bishops ("gravely unethical" -- the bishops also oppose IVF and PGD), Glenn McGee ("this will please no one" -- McGee is described as a long-time critic of ACT), and the immediate past chair of the President's Council on Bioethics, Leon Kass ("'I do not think that this is the sought-for, morally unproblematic and practically useful approach we need.' He said the long-term risk of P.G.D. testing is unknown, and that the present stem-cell technique is inefficient, requiring blastomeres from many embryos to generate each new cell line. It would be better to derive human stem cell lines from the body’s mature cells, he said, a method that researchers are still working on.")
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Sunday, August 20, 2006

Internet prescribing legislation introduced in U.S. Senate

From the Federation of State Medical Boards:

New legislation designed to regulate the sale of prescription drugs and controlled substances over the Internet was introduced in the U.S. Senate on Aug. 10. The “Online Pharmacy Consumer Protection Act of 2006” (SB 3834)would:

  • Prohibit the distribution of controlled substances and prescription drugs via the Internet without a valid prescription issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a practitioner
  • Provide criminal penalties for unlawfully dispensing controlled substances and prescription drugs over the Internet
  • Give state attorneys general a civil cause of action against violators
  • Allow the federal government to take possession of property used illegally by online pharmacies
  • Require online pharmacies to file an additional registration statement with the attorney general and meet additional registration requirements
  • Report to the attorney general all controlled substances and prescription drugs dispensed over the Internet
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Saturday, August 19, 2006

Latest from AHLA's Health Lawyers Weekly (18 Aug 2006)

Herewith, the table of contents of this week's American Health Lawyers' Health Lawyers Weekly (a free member benefit of AHLA):

Top Stories

  • CMS Issues Final Quality Standards For DMEPOS Suppliers
    The Centers for Medicare and Medicaid Services (CMS) released August 14 its final quality standards for suppliers of durable medical equipment, prosthetics, orthotics, supplies, (DMEPOS) and other items and services under the Medicare program. The standards have been scaled-back substantially from the draft version issued in September 2005, thereby reducing the standards document from 104 pages to fourteen pages. Full Story
  • OIG Finds Some MA Marketing Materials Not In Compliance With CMS Requirements
    Some Medicare Advantage (MA) marketing materials for 2005 did not meet the Centers for Medicare and Medicaid Services' (CMS') requirements for marketing, the Department of Health and Human Services Office of Inspector General (OIG) found in a report issued August 14. Full Story

Articles & Analyses

Current Topics

(c) 2006. Reprinted by permission of AHLA.
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Friday, August 18, 2006

It's a good time to be in cardiology

Two items from the print press, courtesy of Modern Healthcare's "Daily Dose":
  • In Philadelphia, heart-transplant centers abound (Philadelphia Inquirer)
    After a massive heart attack last year, doctors told David Kaminstein that he needed a transplant. He had the choice of five hospitals in the Philadelphia area that could do the complicated operation. That's a lot of choices -- some say too many. With the launch of two new heart-transplant centers in recent years, this region has the same number of programs as Los Angeles, though just half the population. Last year, only the Hospital of the University of Pennsylvania -- with 49 transplants -- performed more than 13 of the operations. Most healthcare experts say that the more patients a transplant team treats, the better the results.
  • Angioplasty rates off the charts in Ohio city (New York Times)
    People with blocked coronary arteries can typically choose among drugs, bypass surgery and vessel-clearing procedures like angioplasty. But in Elyria, a small, aging industrial city in northeast Ohio, doctors are much more likely than those anywhere else in the country to steer patients toward angioplasty. No one has accused the doctors involved of any wrongdoing. But the statistics are so far off the charts -- Medicare patients in Elyria receive angioplasties at a rate nearly four times the national average -- that Medicare and at least one commercial insurer are starting to ask questions. And the hospital where most of the procedures take place says it plans to conduct an independent review.
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