Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Sunday, July 27, 2008
All hospitals have to pull their weight on uncompensated care
Wednesday, July 23, 2008
5th Circuit's decision in Poliner is out
medical-staff docs. HCQIA immunity for money damages held to apply to emergency suspension decisions during the fact-investigation phase of the peer-review process. Judge Higginbotham's opinion for a unanimous panel is here. It looks bullet-proof to me . . . . Pretty amazing saga, which I am sure won't be over until there's a petition for reconsideration/rehearing en banc: from a $360-million jury verdict to a remitted judgment for $33 million (still amazing for peer-review case) to $0.
Monday, July 21, 2008
Trying to Save by Increasing Doctors’ Fees
That's the headline in this morning's New York Times' story about health plans (including Medicare) that are going to try to gin up some extra compensation for primary and preventive care in the hope that it will reduce more costly acute care down the road. Could it be? The dawning of the Age of Common Sense? Stay tuned . . .
Thursday, July 17, 2008
Making Malpractice a Criminal Matter
The board alleged that Osathanondh had placed the patient under sedation without any means to monitor her heart rate, blood pressure, or the oxygen level of her blood. The board said the doctor had no qualified person assisting him while Smith was under anesthesia. The only other person in the room was an office worker who had no CPR or other training in lifesaving procedures.
The board added that Osathanondh "failed to timely initiate a call to 911," "failed to maintain an adequate airway," and "failed to adhere to basic cardiac life support protocol."
Osathanondh also allegedly made a variety of false statements to board investigators, telling them that he had administered Smith oxygen and monitored her oxygen levels and that his office worker was certified in lifesaving procedures. He allegedly tried to deceive investigators by expanding the size of his treatment room and bringing in new equipment, which he maintained was there at the time of the abortion.
While it is rare for allegations of medical malpractice to be channeled through the criminal justice system, it's not unheard of. There's a point at which ordinary negligence shades into gross negligence (which can still be handled in the tort system) and at which gross negligence evidences the kind of recklessness that qualifies as a criminal offense. I am not competent to have an expert opinion about what happened in this case, but the cries of outrage about this case resulting in a criminal prosecution are a bit overdrawn. Extreme negligence -- multiple departures and wild departures from the standard of care -- if proved, can properly be a matter for the criminal justice system whether the defendant is a nightclub owner who locks the fire exits (resulting in hundreds of deaths after a fire breaks out) or a member of the medical profession.
Sunday, June 15, 2008
The vaccine-autism debate: a lecture
THE VACCINE-AUTISM DEBATE:WHY WON'T IT GO AWAY?
David Kirby, AuthorEvidence of Harm - Mercury in Vaccines and the Autism Epidemic: A Medical Controversy
Thursday, June 26, 20086:30 - 9:00 PM
NYU School of Law 40 Washington Square South,Vanderbilt Hall, Room 204
RSVP REQUIRED: kirbylecture@gmail.com
FREE AND OPEN TO THE PUBLIC
David Kirby, investigative journalist and author of the New York Times bestseller, Evidence of Harm, will address contemporary legal, scientific and political aspects of the vaccine-autism debate.
Kirby is a former contributor to The New York Times and a regular writer for the The Huffington Post. Mary Holland, NYU Director of the Graduate Legal Skills Program, will introduce Mr. Kirby and moderate the Q&A. Information on Evidence of Harm is at http://www.evidenceofharm.com/ Kirby's Huffington Post essays may be viewed at www.huffingtonpost.com/david-kirby.
Saturday, May 31, 2008
Med mal premiums in Mass., 1975-2005
Massachusetts has the fourth-highest median malpractice settlement payments for all states. The American Medical Association (AMA) declares it a crisis state. As a test case, we analyzed its premiums from 1975 to 2005. In 2005 mean premiums were $17,810 for the coverage level and policy type most frequently purchased. Most physicians paid lower inflation-adjusted premiums in 2005 than in 1990. Mean premiums increased in only three specialties comprising 4 percent of physicians: obstetrics, neurology, and orthopedists–spinal surgery. However, because of discounts and surcharges, in 2005 premiums within the three highest-risk specialties varied nearly threefold, and nearly one-third paid less than in 1990.
American College of Physicians: E-Health Recommendations
Health care may be the fastest growing industry, but it has been slow to adopt the use of technology. While orders at fast food chains are now entirely automated, most physician offices and hospitals still maintain their records on paper.
In [the ACP's] new position paper . . . , the nation’s largest medical specialty organization says that collaboration among physicians, patients, technology developers, and policymakers must occur if e-health activities like electronic communication between physicians and their patients, remote monitoring of patients, personal and electronic health records, and patients seeking health information online are to transform health care in the U.S.
In other words, don't hold your breath.
Two Versions of End-of-Life Care
Tuesday, April 29, 2008
Cash Before Chemo
Once again, it's all too easy in the U.S. system to find yourself underinsured for a serious illness, and when you're underinsured, you might as well be uninsured.
Sunday, April 13, 2008
PBS Frontline: "Sick Around the World"
FRONTLINE presents
SICK AROUND THE WORLD
Tuesday, April 15, 2008, at 9 P.M. ET on PBSFRONTLINE TRAVELS TO FIVE COUNTRIES IN SEARCH OF A UNIVERSAL HEALTH CARE SYSTEM THAT COULD WORK IN THE U.S.
FRONTLINE teams up with T.R. Reid, a veteran foreign correspondent for The Washington Post, to find out how five other capitalist democracies--United Kingdom, Japan, Germany, Taiwan and Switzerland--deliver health care and what the United States might learn from their successes and their failures. In Sick Around the World, airing Tuesday, April 15, 2008, at 9 P.M. ET on PBS (check local listings), Reid turns up remarkable differences in how these countries handle health care--from Japan,
where a night in a hospital can cost as little as $10, to Switzerland, where the president of the country tells Reid it would be a "huge scandal" if someone were to go bankrupt from medical bills.Reid's first stop is the U.K.--a system very different from ours, where the government-run National Health Service is funded through taxes. According to Whittington Hospital CEO David Sloman, "Every single person who's born in the U.K. will use the NHS ... and none of them will be presented a bill at any point during that time." Reid is surprised to find the system often dismissed as "socialized medicine." The U.K. is now trying free-market tactics like "pay-for-performance," where some doctors are paid more if they get good results controlling chronic diseases like diabetes, and patient choice, in which hospitals compete head to head. While such initiatives have helped reduce waiting times for elective surgeries, the London Times' medical correspondent Nigel Hawkes tells Reid the NHS hasn't made enough progress. "We're now in a world in which people are much more demanding, and I think that the NHS is not very effective at delivering in that modern, market-orientated world."
Reid reports next from Japan, the world's second largest economy and the country boasting the best health statistics. The Japanese go to the doctor three times as often as Americans, have more than twice as many MRIs, use more drugs, and spend more days in the hospital, yet Japan spends about half as much per capita as the United States. Reid finds out the secrets of the nation's success: By law, everyone must buy health insurance--either through an employer or a community plan--and unlike in the U.S., insurers cannot turn down a patient for a pre-existing illness, nor are they allowed to make a profit.
Reid's journey then takes him to Germany, the country that invented the concept of a national health care system. For it's 80 million people, Germany offers universal health care, including medical, dental, mental health, homeopathy and spa treatment. Professor Karl Lauterbach, M.D., a member of the German parliament, describes it as "a system where the rich pay for the poor and where the ill are covered by the healthy. It is ... highly accepted by the population." As they do in Japan, medical providers must charge standard prices which are negotiated with the government every year. As a consequence, physicians in Germany earn between half and two-thirds as much as their U.S. counterparts.
Taiwan researched many health care systems before settling on one where the government runs the financing, but Reid finds the delivery of health care is left to the market. Taiwanese health care offers medical, dental, mental and Chinese medicine, with no waiting time and for less that half of what we pay in the United States. Every person in Taiwan has a "smart card" containing all of his or her relevant health information, and bills are paid automatically. But what Reid finds is that the Taiwanese spend too little to sustain their health care system. According to Princeton's Tsung-Mei Cheng, who advised the Taiwanese government, "As we speak, the government is borrowing from banks to pay what there isn't enough to pay the providers."
Reid's final destination is Switzerland, a country whose health care system suffered from some America's problems until, in 1994, the country attempted a major reform. Despite a huge private insurance business, a law called LAMal was passed, which set up a universal health care system that, among other things, restricted insurance companies from making a profit on basic medical care. Today, Swiss politicians from the political right and left enthusiastically support universal health care. Pascal Couchepin, the president of the Swiss Federation, argues: "Everybody has a right to health care. ... It is a profound need for people to be sure that if they are struck by destiny ... they can have a good health system."
Friday, April 11, 2008
Some basic health-reform lessons
1. Just because you have health insurance today don't assume that means you will have it tomorrow. Employers drop employee health plans when they become too expensive. Bankrupt employers aren't obligated to continue health insurance for retirees, regardless of previous bargained-for promises. Annual and life-time caps on benefits can wipe out future benefits. And plan coverage can be manipulated so that your particular needs are no longer covered.
2. The uninsured are charged more for their health care than the insured. The resulting bad credit and outstanding balances may limit future access to health care.
3. The emergency-room option that is virtually guaranteed by EMTALA and was touted by President Bush as a health-care safety net is no substitute for insurance coverage and access to primary and preventive care. Lots of people delay care until they have a "true emergency" -- they will still be billed for the care they receive, regardless of ability to pay. (In fact, even insured patients have good reason to postpone ER visits, unless they live in a state that requires managed care plans to pay for the ER services, even if there was no true emergency, as long as a reasonable layperson would have thought they had a medical emergency.
4. The lack of universal coverage that every other developed country seems to be able to afford isn't simply an "access" problem. People get sicker, stay sicker longer, and die as a result of care that is postponed or not sought when it could still be useful.
Monday, April 07, 2008
More medical records abuses
Tuesday, March 18, 2008
Law review call for papers: "Preparing for a phamaceutical Response to Pandemic Influenza"
Preparing for a Pharmaceutical Response to Pandemic Influenza
Co-sponsored by the Health Law & Policy Program’s Center for Health & Pharmaceutical Law and the Gibbons Institute of Law, Science & Technology
October 23-24, 2008
Seton Hall Law School
Newark, NJ
Call for Papers
Persons interested in participating as a panelist and/or in publishing a piece in the special symposium issue of the Seton Hall Law Review should submit a CV and a 200-word abstract of their presentation to Julie Sauer, Symposium Editor, by April 15, 2008. Julie Sauer may be reached at (201) 739-7310 / sauerjul@shu.edu. Prospective panelists should indicate whether they would be interested in submitting a paper based on their presentation for publication. Contributions are welcome from scholars and practitioners in all disciplines.
For more information, please visit the Seton Hall Law Review symposium website at http://law.shu.edu/journals/lawreview/symposium2008.htm.
Wednesday, March 05, 2008
For the placebo will work and you will think you know why
For the placebo will have side effects and you will know you
do not know why
Tuesday, March 04, 2008
Are antibiotics futile for nursing home patients with advanced dementia?
This prospective cohort study demonstrates that antimicrobial exposure among nursing home residents with advanced dementia is extensive and steadily increases toward the end of life. During the follow-up period (mean follow-up, 322 days), two-thirds of the subjects were prescribed at least 1 course of antimicrobial therapy and, on average, a total of 4 courses. Among the residents who died, 42.4% received antimicrobials during the last 2 weeks of life, often via a parenteral route. The proportion of residents taking antimicrobials was 7 times greater in the last 2 weeks of life compared with 6 to 8 weeks before death. This extensive use of antimicrobials and pattern of antimicrobial management in advanced dementia raises concerns not only with respect to individual treatment burden near the end of life but also with respect to the development and spread of antimicrobial resistance in the nursing home setting. . . .
Treatment decisions for infections in advanced dementia can be difficult for family members and caregivers. The 2 purported reasons to administer antimicrobials are life prolongation and symptom control. Limited observational studies have failed to demonstrate that antimicrobial treatment achieves either outcome in this frail population; however, randomized trials have not been conducted. Our findings further support that antimicrobials may not meaningfully extend the life of patients with advanced dementia for whom infections are frequently a terminal event. Palliation is often the main goal of care in this condition. It is difficult to assess the extent to which infections cause suffering in patients with advanced dementia. Previous work demonstrates that pneumonia is an uncomfortable experience for these patients and suggests that antimicrobial therapy may improve symptoms. However, it remains unclear whether antimicrobial therapy promotes symptomatic relief beyond what can be achieved by high-quality palliative treatment with more conservative modalities (eg, oxygen and acetaminophen). Finally, it is also important to minimize inappropriate antimicrobial exposure. For example, up to one-third of antimicrobials prescribed in nursing homes are for asymptomatic bacteriuria, for which treatment is not indicated. Antimicrobial administration has associated risks in the frail elderly population that merit consideration. Older persons are particularly susceptible to the adverse effects of antimicrobials owing to altered pharmacokinetics, polypharmacy, dosing errors, and an increased risk of Clostridium difficile infections. Moreover, parenteral administration, which was common in our cohort, can be an uncomfortable procedure in advanced dementia. Thus, from the individual patient's perspective, the balance of advantages and disadvantages of antimicrobial treatment of infections in advanced dementia remains unclear, regardless of the primary goal of care.
On a broader level, the emergence and spread of antimicrobial-resistant bacteria is a major public health concern. Older persons account for one of the largest patient reservoirs of these organisms. In particular, up to 40% of residents living in nursing homes harbor at least 1 species of antimicrobial-resistant bacteria. Once admitted to the hospital, these nursing home residents contribute substantially to the influx and spread of antibiotic-resistant bacteria. Exposure to antibiotics is strongly associated with the development of antibiotic resistance. Quinolones and third-generation cephalosporins were the most frequently prescribed antimicrobials in our cohort. Several studies have reported that more than 50% of isolates recovered from nursing home residents are resistant to these 2 classes of drugs. These observations and the extensive use of antibiotics found in this study raise the serious concern that nursing home residents with advanced dementia may be contributing to the emergence and spread of antimicrobial-resistant bacteria, posing health risks that extend beyond the individual being treated. . . .
Infections and febrile episodes are a hallmark of end-stage dementia. The extensive antimicrobial use demonstrated in this study is concerning given the lack of demonstrable benefits and the potential burdens of treatment in this terminally ill population for whom the goal of care is often palliation. Moreover, we believe that the widespread use of antibiotics in advanced dementia may pose a potential public health risk through the emergence of antibiotic resistance. This hypothesis requires further research. Meanwhile, from individual and societal perspectives, our study supports the development of programs and guidelines designed to reduce the use of antimicrobial agents in advanced dementia.
The accompanying editorial in Archives explictly frames the study in terms of medical ethics generally and "futility" in particular. The editorial poses this question: "If antibiotics are not required to restore comfort to an infected patient (either because the patient is in no distress or because palliation can be achieved by other means) and cannot be expected to enhance duration or quality of life, might not their use be considered futile?," which it then answers, "Prior investigators have indeed come to this conclusion" [footnote omitted]. So far, so good. If the purposes for which antibiotics would be prescribed are not likely to be attained, their use lacks a pathophysiologic rationale, a classic "futility" rationale. This is especially so because there are some negative consequences for the elderly and the overuse of antiobiotics in this population (as in any other) contributes to some degree in the development of antiobiotic resistant bacteria, a significant source of morbidity and mortality in hospitals.
But then the editorialist continues: "Even if antibiotics may prolong life, should they be used if they will not enhance quality of life?" This is a fair question only if it is separated from the issue of "futility." In common parlance, invocation of the "futility" label confers upon the practitioner the moral right to withhold or withdraw a medical intervention, even over the objections of the patient or the patient's surrogate decision maker. If the intervention does have a pathophysiologic rationale (prolongation of life), I would argue that "futility" is no longer the proper ethical framework for the discussion. As with any other intervention that may prolong life without necessarily increasing the quality of life, a discussion with the patient or the surrogate is certainly appropriate. A unilateral decision to withhold the drug(s) (or the discussion) is not. The editorial writer appears to agree with this: "The solution is not to categorically deny antibiotics to the severely demented elderly, or even to impose limits on their use or their spectrum as a matter of policy. Such decisions, in addition to being ethically untenable, would run counter to the expressed wishes of patients and their families. We must, however, begin to consider every decision to use antibiotics in this population as we would decisions regarding other treatment modalities, including resuscitation and major surgery."
According to the Times, Prof. Paul Appelbaum at Columbia sees things the same way: “The apparent suggestion that we should not be treating persons with dementia when they develop infections rests on a normative judgment — that does not flow from these data — that their lives are worth less than the unknown degree of risk of contributing to antibiotic resistance. Although one cannot ask the patients themselves how they feel about this judgment, many of their family members and caregivers would disagree, and our society — fortunately, in my view — has not yet reached the point where it is willing to embrace it.”
Monday, March 03, 2008
Location, location, location.
Black VLBW infants are more likely to be born in New York City hospitals with higher risk-adjusted neonatal mortality rates than are white VLBW infants. Our data document that these disparate patterns of utilization explain more than one third of the black/white racial disparity in VLBW neonatal mortality rates in New York City. We used population-based vital statistics data from the nation's largest city to detail these variations and disparities.
The finding that, in New York City, black infants who are born too small systematically receive care in institutions with worse outcomes, compared with those where white infants receive care, demands immediate attention. Our data suggest that improving outcomes at the lowest-performing hospitals may produce the greatest benefit. Because effective treatments for prematurity exist, ensuring that such treatments are used consistently at all hospitals at which VLBW infants receive care is a vital first step toward this improvement goal. Our findings define an imperative to improve care in New York City and to study other urban areas to identify and to ameliorate such trends. The excess deaths suffered by these tiny infants and their contributions to black/white disparities are unacceptable.
Wednesday, February 27, 2008
Donation after cardiac death and the LA story
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.”
Sunday, February 24, 2008
Organ donation, transplant discussed on NPR
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
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.