Wednesday, February 27, 2008

Donation after cardiac death and the LA story

The papers are all over yesterday's story about the prosecution of a young surgeon in Los Angeles who is accused of hastening a patient's death (or, to be less circumspect but at least as accurate about it, of killing a patient) in order to procure organs for transplant. Here's how the New York Times' front-page story begins:

On a winter night in 2006, a disabled and brain damaged man named Ruben Navarro was wheeled into an operating room at a hospital here. By most accounts, Mr. Navarro, 25, was near death, and doctors hoped that he might sustain other lives by donating his kidneys and liver.

But what happened to Mr. Navarro quickly went from the potentially life-saving to what law enforcement officials say was criminal. In what transplant experts believe is the first such case in the country, prosecutors have charged the surgeon, Dr. Hootan C. Roozrokh, with prescribing excessive and improper doses of drugs, apparently in an attempt to hasten Mr. Navarro’s death to retrieve his organs sooner.

A preliminary hearing begins here on Wednesday, with Dr. Roozrokh facing three felony counts relating to Mr. Navarro’s treatment as a donor. At the heart of the case is whether Dr. Roozrokh, who studied at a transplant fellowship program at the Stanford University School of Medicine, was pursuing organs at any cost or had become entangled in a web of misunderstanding about a lesser-used harvesting technique known as “donation after cardiac death.”

Donation after cardiac death will require more extensive treatment here than I have time for today, but -- regardless of what the facts eventually are shown to be in the Roozrokh case -- the publicity surrounding this case is already a public-relations setback for the organ transplant community. And if it turns out that "lethal doses" or morphine and Ativan, not to mention the IV administration of the topical disinfectant betadine, were administered, "setback" will be the mildest term to describe the situation.

The concept of death by morphine overdose brings to mind the Pou case out of New Orleans, in which similar charges were brought against Dr. Pou in the wake of Hurricane Katrina. The grand jury there refused to indict her, though she continues to face civil actions in connection with the deaths of some of the patients she attended to. For a truly impressive expert analysis of that case, as well as an enlightening discussion of the lack of support in the medical literature for a temporal connection between morphine administration and time of death, you could do no better than Dr. Steven Miles' report, which was prepared at the request of Dr. Pou's defense team.

Sunday, February 24, 2008

Organ donation, transplant discussed on NPR

Weekend Edition - Sunday had a very fine segment this morning on organ donation.

Given what they were trying to do with this piece, there probably wasn't time to portray the personal impact of donating and receiving, convey some of the statistics about the various waiting lists, provide a brief overview of some of the evolving strategies for increasing organ yields, AND discuss some of the ethically troubling developments in this field. For the darker side of donation, you'll have to look elsewhere (here, here, and here).

Thursday, January 03, 2008

Human experimentation research request

From Jim DuBois, PhD, DSc, Mäder Endowed Professor, Department Chair and Center Director, Center for Health Care Ethics & Becky Volpe, Graduate Assistant, Center for Health Care Ethics:

We are studying the personality and environmental factors that contribute to major ethical breaches in the areas of medical practice and research. An example of a major breach would be the Tuskegee syphilis trial. We plan to examine 25-100 cases of “ethical disasters”, and then analyze characteristics of the cases to find relationships, similarities, and differences. We will be including only those cases that occurred after the year 1900 and are documented in published sources.

We had hoped that, given your expertise, you would be willing help us generate a list of possible cases for inclusion. To nominate cases for review, please email Becky Volpe at rvolpe@slu.edu.

Thank you very much for your time.

Sunday, December 16, 2007

Medical Futility Blog

I don't know how I missed it, but here (better late than never) is a link to Prof. Thad Pope's estimable Medical Futility Blog, which does a nice job of tracking legal developments and the on-going political and scholarly debate over what to do (if anything) about claims for "futile" treatment.

Health reform: the time for happy chatter is over

Robert Samuelson -- Newsweek columnist and Washington Post op-editorialist -- had a typically fine piece in last Thursday's Post. Here's the nub of his argument:

We're told that the uninsured are our biggest health-care problem, but they aren't. Runaway health spending is. although politicians pay lip service to that, what they really enjoy is increasing spending.

It's understandable because expanding benefits is so much more politically rewarding than trying to control them. Everyone believes in adequate health care; people should have it when they need it. Politicians cater to these beliefs. But the intellectual and even moral laziness of this approach results in an invisible abdication of political responsibility. We are letting the unchecked rise in health spending determine national priorities. Consider:

  • Health spending already totals more than $2 trillion annually, about 16 percent of national income (gross domestic product). By 2030, it could easily exceed 25 percent -- one dollar out of four -- projects the Congressional Budget Office.
  • There's a massive transfer of income from young to old. Americans 65 and older now represent about an eighth of the population and account for about a third of all health spending. By 2030, their population share will be about a fifth, and they could account for nearly half of health spending, the Centers for Medicare and Medicaid Services has found.
  • Neither the government nor the private sector has succeeded in controlling health spending. From 1970 to 2005, average spending per Medicare beneficiary rose 8.9 percent a year. For similar services, spending for Americans with private health insurance rose 9.8 percent annually over the same period. The small difference may reflect cost shifting. When Medicare imposes price controls, doctors and hospitals increase prices for privately insured patients.

Samuelson argues for changes that illuminate rather than obscure the costs of care -- by increased cost-sharing by Medicare beneficiaries, a dedicated federal health-care tax to pay for all federal health programs (as the costs go up, the tax goes up), and elimination of the federal tax subsidy for employer contributions to employee health benefit plans. This is hardly new stuff: all of these ideas have been kicking around for years, and most health care economists seem to agree that cost control won't be possible without reducing the role of third-party payors and putting more of the cost of care on consumers.

Samuelson's contribution to the debate is to point out that the debate so far is largely missing a very big -- possibly the big -- point. Here's why:

These proposals would inflict "pain," and candidates who embraced them would invite political ruin. There's a consensus for evasion that most politicians echo. The impulse is to focus on a simpler problem -- say, the uninsured. In some ways, this is less serious than it seems. About 40 percent of the uncovered are young (18 to 34); most are healthy and don't need much care.

But for all the uninsured, the cost of coverage is a major obstacle. Health care is ultimately a political issue of making choices. Our present politics aims to camouflage the costs and skew the choices. Until we change that, our debates will lead to dead ends.

Monday, December 03, 2007

ACP publishes advance copy of major health reform policy statement

Intending to be a major player in the 2008 debate over health reform and universal coverage, the American College of Physicians has posted an advance copy of an article that will appear in its January 1, 2008, issue of Annals of Internal Medicine: "Achieving a High-Performance Health Care System with Universal Access: What the United States Can Learn from Other Countries." Full-text is available for free here. It's 21 pages long, heavy on statistics, and an indispensable critical analysis of our system's strengths and weaknesses.

On the crucial question of how to achieve universal coverage, the ACP basically punts, presumably because the country isn't (and may never be) politically ready for a single-payer system:

Universal health care insurance is necessary to ensure that everyone within the United States has access to needed health care services of high quality. The federal government should assure that all persons within the borders of the United States also have access to health care services without undue financial barriers and that health care services provided are adequately reimbursed. The ACP recommends two alternatives: a system funded solely or principally by government (federal and states), commonly known as a single-payer system, or a pluralistic system that incorporates existing public and private programs with additional guarantees of coverage and with sufficient subsidies and other protections to assure that coverage is available and affordable for all. The ACP has [elsewhere] proposed a step-by-step plan that would achieve universal coverage while maintaining a pluralistic system of mixed public and private sector funding.
Here's how it ends:

Summary and Conclusions

Health care in the United States has many positive features and in many respects is superb compared with health care anywhere else in the world. Those with adequate health insurance coverage or sufficient financial means have access to the latest technology and the best care. However, as this paper points out, the U.S. health care system is inefficient and inconsistent: Health care quality and access vary widely both geographically among populations, some services are overutilized, and costs are far in excess of those in other countries. Moreover, the United States ranks lower than other industrialized countries on many of the most important measures of health.

Current international comparisons of measures of health (life expectancy at birth, infant mortality, and deaths per 100 000 for diseases of the respiratory system and for diabetes) indicate that population health in the United States is not better than in other industrialized countries despite the greater U.S. expenditures (58). The experience and innovations of health care systems in other countries provide many lessons as the United States tries to improve its health system. Among these lessons are the value of an orientation and emphasis on patient-centered primary care and the importance of assuring a well educated physician workforce that meets the country's need for primary care physicians.

The quality and accessibility of health care in the United States could be improved by adopting reimbursement programs like those in other countries that provide substantial rewards based on performance on quality metrics and care coordination rather than solely on the volume of services provided. These payment systems together with national workforce planning might also help address the impending primary health care workforce shortages in the United States. Universal and compulsory health insurance coverage could eliminate many of the disparities and inequities in the United States. Expanded use of health information technology and substantial governmental investments and support for a health information technology infrastructure with appropriate patient privacy protections could enhance health care decision making by physicians and patients and would bolster the growing movement for consumer-directed health care. These are some of the lessons we can learn from other industrialized countries.

Other lessons for a more efficiently functioning health care system include achieving lower administrative costs by standardizing coverage and insurance transactions; providing coverage through publicly funded programs rather than private insurance; and automating transactions among providers, patient, and insurers. This article does not address many other issues in depth. Topics for further in-depth analysis include the costs and impact of malpractice liability insurance, determination of prescription drug prices, differences in medical education (including costs and student debt), financing long-term care, and physician earnings and income. The United States may also benefit by examining how other countries manage end-of-life care, determine the distribution of health care resources, and make decisions on coverage and benefits.

The ACP has offered a series of recommendations to achieve a well-functioning health care system. All Americans should have access to a primary care physician and should have a patient-centered medical home for their ongoing, continuous,
comprehensive, and coordinated care. All Americans should have health insurance coverage that includes preventive and primary care services, as well as protection from catastrophic health care costs. Federal health policy should support the patient-centered primary care model. The United States lacks a national health care workforce policy. It should provide for sufficient support for the infrastructure required to educate and train an adequate supply of health professionals that would properly meet the nation's health care needs, including primary and principal care physicians that are trained to manage care of the whole patient. Workforce planning should specify an appropriate mix of physicians between primary and specialty care and describe the policies required to achieve that goal. Public and private investments in research must continue to support advances in basic and clinical medical science as well as in health services research. Other ACP recommendations call for financial incentives to encourage quality improvement and reduction of avoidable medical errors, support for a health information technology infrastructure to assist patients and physicians in making informed decisions about the appropriate use of health care services, and use of technology to achieve a more efficient health care system.

The main lesson of this article is that many countries have better functioning, lower cost health care systems that outperform the United States. We must learn from them.

Sunday, December 02, 2007

New York City Law Review Issues Call for Papers on Health Care

The New York City Law Review announces a call for papers for its spring symposium, "Critical Condition: What's Ailing Health Care in America?" This event will be held Friday, March 28, 2008, at the Association of the Bar of the City of New York's Meeting Hall in Midtown Manhattan.

The Symposium will look at two critical questions: (1) Can international human rights frameworks help the United States overcome obstacles to universal coverage? and (2) Can innovative litigation expand coverage to vulnerable populations? Given that the 2008 general election has already placed health care as a central campaign theme, now is a critical time to evaluate the practical litigation and policy models for providing access to the uninsured and vulnerable populations, says Matthew Monroe, one of the symposium's organizers. For more details on the symposium and how to make topic submissions, visit: http://www.nyclawreview.org/

AHLA Health Lawyers Weekly, Nov. 30

Some interesting stuff in the Health Lawyers Weekly this time around:

Top Stories

Articles & Analyses

Current Topics

(c) 2007, American Health Lawyers Association. Reprinted by permission.

Informed consent & SCOTUS: A tale of two doctrines

Interesting paper . . .

The Constitutional Right to Make Medical Treatment Decisions: A Tale of Two Doctrines
JESSIE HILL
Case Western Reserve University - School of Law
Texas Law Review, Vol. 86, No. 2, December 2007
Case Legal Studies Research Paper No. 07-28

Abstract:

The Supreme Court has taken very different approaches to the question whether individuals have a right to make autonomous medical treatment choices, depending on the context. For example, in cases concerning the right to choose “partial-birth” abortion and the right to use medical marijuana, the Supreme Court reached radically different results, based on radically different reasoning.


More recent developments, including last Term's decision in Gonzales v. Carhart, have only highlighted the doctrinal confusion and the need for a resolution. In light of this pressing need, the goal of this Article is to view all of the constitutional cases touching on medical treatment decisions as one body of doctrine, as no other scholar has done. And indeed, this new perspective reveals that there are in fact two distinct lines of constitutional doctrine touching on the right to make medical treatment decisions: the “public health” line of cases, which emphasizes the police power of the state over individual rights, and the “autonomy” line of cases, which emphasizes individual bodily integrity and dignitary interests. Those lines of cases have grown up in parallel, appearing to represent airtight doctrinal categories while in fact addressing the same fundamental question. In addition, courts have applied varying degrees of deference to legislative determinations of medical fact without any logical consistency, perhaps based on largely superficial determinations about what type of case is before it.


This Article concludes that a constitutional right to protect one's health should be consistently recognized; that the recognition of this right should not be artificially limited by excessive deference to legislative findings of medical fact; and that this right will have to be carefully balanced against the state's real and legitimate interest in regulating the practice of medicine to protect the public.

Top Ten Health Law Stories in 2008: FDA

There's no denying either the urgency of the FDA's mess or the bipartisan political appeal of the issue of food and drug safety. Consider this lead from the New York Times' Nov. 29 article on the latest report describing the agency's woes:

The nation’s food supply is at risk, its drugs are potentially dangerous and its citizens’ lives are at stake because the Food and Drug Administration is desperately short of money and poorly organized, according to an alarming report by agency advisers.
The report can be found here. (If the lack of an easily navigable website is any indication of agency disorganization, the FDA must be the poster child for agency chaos. This report is almost impossible to find using any of the links on the website. Then again, considering the devastating critique contained in the report, maybe the powers-that-be are trying to make it hard to find.)

Here are some of the major findings:
  • The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
    • FDA does not have the capacity to ensure the safety of food for the nation.
    • The development of medical products based on “new science” cannot be adequately regulated by the FDA.
    • There is insufficient capacity in modeling, risk assessment and analysis.
    • FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.

  • The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
    • The FDA has substantial recruitment and retention challenges.
    • The FDA has an inadequate and ineffective program for scientist performance.
    • The FDA has inadequate funding for professional development.
    • The FDA has not taken sufficient advantage of external and internal collaborations.

  • The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
    • The Subcommittee believes that there is evidence of important, but slow, progress to improve information sciences and technology at the FDA over the past few years, yet significant gaps remain.
    • The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
    • The FDA cannot provide the information infrastructure support to regulate products based on new science.
    • The FDA IT infrastructure is obsolete, unstable, and lacks sufficient controls to ensure continuity of operations or to provide effective disaster recovery services.
    • The IT workforce is insufficient and suboptimally organized.

If that's not enough to make your Post Toasties wilt, I don't what is . . . .

Friday, November 30, 2007

WSJ: Health policy caps mean catastrophic coverage may not be there when needed



Yesterday's WSJ ran a story that highlights the plight of the insured middle-class in this country: It's possible to max out a health policy with a $1.5 million cap in the metaphorical blink of an eye. The story is here (though it may require a paid subscription to read it).

Tuesday, November 27, 2007

When hospice patients don't die quickly enough, Medicare comes knocking

Some years ago, the Medicare program proposed to recoup hospice payments if a patient didn't die within 6 months, which was the probable life-expectancy that a physician had to certify for a patient to receive the Medicare hospice benefit. As I recall, that proposal was met with howls of protest and dropped.

What Medicare couldn't do directly, however, it is now doing indirectly, as described in an article in today's New York Times. With an annual cap on total hospice payments ($21,470 [slightly less than six months of daily payments of $135] x the total number of hospice patients served in a year), Medicare can recoup "excess" payments from any hospice that received reimbursement from the program above the annual cap. In some cases, the amount of recoupment is in the high six figures. The hardship on hospice programs is palpable -- most don't have the kind of profit margins that allow them to pay back to Medicare a year or more after the money has been spent on salaries, supplies, and other overhead.

Part of the problem for some hospices may be bad patient mix (i.e., not enough terminal cancer patients with more predictably short life expectancies), and there may be management issues, as well. But shouldn't there be a better solution to this problem than penalizing hospices whose patients don't die fast enough to satisfy federal regulations? As one physician is quoted in the article, "Doing this for 40-something years, every time I think somebody is going to die tomorrow, damned if they don’t live for a year and a half." Do we really want to have a federal policy that regards that result as a failure?

Friday, November 09, 2007

Krugman: Health Care Excuses

Okay, I know he's a liberal (Exh. 1: "The Conscience of a Liberal"), and so am I, so there are times when I suppose Paul Krugman's arguments seem irresistible when they're not. But today's column strikes me as just plain common-sensical.

Krugman offers up four common excuses often used to argue against health reform and then refutes them. It is worth a read. Here are the excuses:
  • Excuse No. 1: No insurance, no problem.

  • Excuse No. 2: It’s the cheeseburgers.

  • Excuse No. 3: 2007 is better than 1950.

  • Excuse No. 4: Socialized medicine! Socialized medicine!

And, by the way, a big shout out to the managers at The New York Times who have stopped putting the good stuff where only subscribers could get to it. I don't know what their new business plan is, or how they can afford it, but I am grateful for total Web access (i.e., the same as The Washington Post). As a subscriber, I've always had it, but as a blogger it was frustrating not being able to share so much as a link. Those days are now blissfully over!

Insurer misconduct alleged in California


From today's Modern Healthcare:

Calif. insurance chief probes report of cancellations

California’s insurance commissioner is investigating a report that Health Net rewarded an analyst more than $20,000 in bonuses tied to canceling individual health insurance policies, thereby saving the company millions in medical expenses.

“We certainly view this as a serious breach,” said Byron Tucker, spokesman for state Insurance Commissioner Steve Poizner.

The Los Angeles Times reported that Health Net revoked 1,600 policies between 2000 and 2005, saving the Woodland Hills, Calif.-based insurer $35.5 million in medical payments. The company set policy rescission targets, which the senior analyst in charge of cancellations regularly exceeded, earning her praise and monetary rewards, according to the newspaper.

Tying compensation of claims reviewers to their actions is illegal under state law.

“The characterization of our compensation programs is inaccurate and misleading,” Health Net said in a written statement.

The bonuses were disclosed during an arbitration hearing on a $6 million lawsuit brought by a 51-year-old hairdresser from the Los Angeles area whose Health Net policy was revoked during her chemotherapy treatments for breast cancer. The Times’ lawyers intervened to have the documents unsealed, according to the newspaper.

Here's a link to the LA Times article that broke the story. The picture quality is pretty bad, but you can see from copies of the insurance analyst's performance review (above) that she was being evaluated, at least in part, on the basis of the number of rescissions she produced and the corresponding contribution she made to the company's bottom line.

Thursday, October 25, 2007

Deputies seize baby to test blood against parents' will

Deputies seize baby to test blood against parents' will - Associated Press -- Here's a nicely framed conflict between public health laws designed to protect newborns vs. parental religious beliefs, in state (Neb.) that doesn't provide a religious exemption for newborn testing. Absent a First Amendment claim (which would fail), the only constitutional argument would be a claimed infringement of the parent's liberty interest in violation of the due process clause . . . rational basis review . . . slam dunk for the county. This falls into the same class of cases involving Jehovah's Witness minors in need of a blood transfusion.

Sunday, October 21, 2007

Iglehart on the House's failure to override Bush's SCHIP veto

John Iglehart, the founding editor of Health Affairs and national corespondent for the New England Journal of Medicine, posted his instant analysis [may require paid subscription] of the House's failure on Thursday to override the President's veto of the SCHIP reauthorization bill, HR 976. Iglehart's provides an excellent overview of the controversy and connects this contretemps to "the larger issue of what level of public support uninsured people deserve as our employer-based insurance system continues to erode." Excellent read.

Saturday, October 20, 2007

Federeal employees' health plan not much of a model for reform

There's a good analysis of the Federal Employees Health Benefits Plan (FEHBP) by Reed Abelson in The New York Times today. Various presidential candidates are talking about the FEHBP in their stump speeches, suggesting that this country's 47 million uninsured could be covered by the same plan that covers their elected representatives. Bottom line: There's really nothing about the FEHBP that would either materially improve the uninsureds' access to health insurance or help to rein in costs. It's a private-insurance system with insurers competing for business. Underwriting, including favorable selection, and generous benefits largely replicate the problems the rest of us experience in our own private, employment-based system, and expanding FEHBP to 8 times more individuals than it currently covers would require changes in the program that would render it "FEHBP" in name only.

Tuesday, October 02, 2007

SCHIP

Here's a news post courtesy of FDLI's SmartBrief:

White House to face state SCHIP lawsuits -- New Jersey was the first of several states expected to file lawsuits against the Bush administration over rules set in August that limit state coverage of children's health insurance to exclude children in middle-income families. Arizona, California, Illinois, Maryland, New Hampshire, New York and Washington also say they plan to file or support lawsuits challenging the rules, claiming that the income limits set by the administration breach federal government authority on SCHIP and make it more difficult for them to provide coverage for children. "Our chief goal with SCHIP is to ensure that the poorest kids and those with no health insurance are placed at the front of the line," a CMS spokesman countered. Courier-Post (Camden-Cherry Hill, N.J.) (10/2), The Washington Post (10/2), Forbes/Associated Press (10/1).

Interesting development, this. This issue of whether higher eligibility cutoffs for SCHIP will put on the federal dole middle-class kids who would otherwise be covered by private insurance is at the heart of the White House's veto of the new SCHIP authorization bill (H.R. 976), too. Terence Hunt is reporting (AP/Washington Post) this afternoon that Pres. Bush has announced his intention to veto the SCHIP reauthorization bill on Wednesday, and that there will be no ceremony for the television cameras. Too bad: I was hoping to be able to post the YouTube video of the veto ceremony. Guess I'll have to go with something else . . . .

Sen. Susan Collins (R-Me.)

Friday, September 28, 2007

FDA's oversight of human-subject research: slim to none

That's the bottom line of a report from the Inspector General of DHHS, according to an article in the New York Times. The IG's report (pdf), and a news release (pdf) about its conclusions, were released today. In his typically media-friendly way, Art Caplan colorfully summarized the report's conclusions this way: "In many ways, rats and mice get greater protection as research subjects in the United States than do humans."