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
Six-term Democratic Congresswoman Diana DeGette owns a dubious distinction: She is one of the two co-authors of the bill that garnered President George W. Bush's first-ever veto.
The subject of the legislation: embryonic stem cells. DeGette, who represents Colorado's 1st District—which includes Denver and its environs—is for them. The president isn't.
On July 19, 2006, President Bush ceremoniously vetoed the bill, the Stem Cell Research Enhancement Act of 2005, even though it had passed both the House and Senate by wide margins—though the gaps were not large enough to override a veto. When he signed the veto, the chief executive was surrounded by so-called "snowflake babies," kids born from discarded IVF (in vitro fertilization) embryos that other couples had "adopted" through a Christian agency. These children wouldn't exist, he said, if embryos were used for stem cell research.
These publicity stunts, according to DeGette, have helped kill a wide range of legislation on sex and reproduction: the plan B "morning after" birth control pill, the human papillomavirus vaccine (touted as the best method for preventing cervical cancer), and even sex education—many Republicans advocate abstinence-only instruction.
[from today's Kaisernetwork.org's Daily Health Policy Report]
Although U.S.-born residents still make up the majority of uninsured U.S. residents, the percentage of uninsured documented and undocumented immigrants is growing, according to a study released on Tuesday by the Employee Benefit Research Institute, the Kansas City Star reports. EBRI researchers analyzed U.S. Census data for the study and found that immigrants accounted for 18.8% of uninsured residents in 1994 and 26.6% in 2006, the last year in which data were available. According to the study, 12.3 million immigrants and 34.1 million U.S.-born residents were uninsured in 2006.
In 2006, more than 46% of noncitizen immigrants were uninsured, compared with 19.9% of immigrants who gained citizenship and 15% of U.S.-born residents. The study found several factors that contributed to the higher number of uninsured immigrants. Immigrants are more likely to take lower-wage job positions that typically do not offer health insurance benefits, according to the study. In addition, the Personal Responsibility and Work Opportunity Act of 1996 contributes to the figures because it mandates that documented immigrants live in the U.S. for five years before they become eligible for government-sponsored health care and other programs. The study also found that the longer immigrants lived in the U.S., the more likely they were to acquire health insurance.
According to the study, 58.7% of uninsured immigrants lived in California, Texas, Florida or New York. The study did not define whether an immigrant was documented or undocumented (Kansas City Star, 8/5). The study is available online (.pdf).
Emergency Preparedness: States Are Planning for Medical Surge, but Could Benefit from Shared Guidance for Allocating Scarce Medical Resources. GAO-08-668, June 13, 2008 (53 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-08-668
Medicaid Home and Community-Based Waivers: CMS Should Encourage States to Conduct Mortality Reviews for Individuals with Developmental Disabilities. GAO-08-529, May 23, 2008 (49 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-08-529
Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices. GAO-08-452, June 13, 2008 (49 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-08-452
VA Health Care: Ineffective Controls over Medical Center Billings and Collections Limit Revenue from Third-Party Insurance Companies. GAO-08-675, June 10, 2008 (57 pages). http://www.gao.gov/docdblite/details.php?rptno=GAO-08-675
For those interested in charity care and community benefits in Texas, the Texas Attorney General is hosting a "summit" on Tuesday, September 16, in Austin. The schedule looks pretty good, if a little basic, but it's the Attorney General's office, for crying out loud, and they do have enforcement authority for Health and Safety Code chapter 311 (though it would be nice to know whether the speakers include OAG personnel or members of the private bar):
8:30 AM - Charity Care and the Patient Panel Discussion Correctly identifying and communicating with charity care patients and formulating effective charity care policies and procedures will maximize the effectiveness of nonprofit hospital charity care programs. This panel will offer options to better communicate with this patient population while educating hospitals on common pitfalls in charity care compliance, suggesting policies to improve documentation and exploring alternatives to help hospitals care for those in greatest need.
9:30 AM - Governance Best Practices What is your governance strategy? As a board member do you routinely demand and receive specific documents? Do you have a financial management plan? This speaker will capsulize best practices for hospitals; discuss the leading governance trends with a focus on executive compensation; and offer guidance for implementing best practices to be a h5er [sic], healthier organization.
10:15 AM - Break
10:30 AM - Two Concurrent Breakout Sessions
1. What is The True "Cost" of Health Care? The excessive cost of health care is a topic of considerable focus in America today. This presentation will explore the method of defining the actual "cost" of care through a review of variables used to account for specific costs while offering suggestions as to which of these variables should and should not be included in charity care cost determination.
2. Joint Ventures – Doctor-owned Hospitals Panel Discussion Hospital-physician joint ventures are a major strategic focus of many nonprofit hospitals. Regardless of the configuration, such ventures can present legal and business risks while providing a healthy choice for both the patients and the hospital. This panel explores the pros and cons of these alternative joint ventures.
11:30 AM - Break
11:45 AM - Keynote Luncheon The Honorable Greg Abbott, Attorney General of Texas
12:45 PM - Break
1:00 PM - Community Benefits Panel Discussion In Texas, all nonprofit hospitals are required to prepare community benefit plans based on community needs. The plans must state how the identified community needs will be addressed. Frequently, hospitals do so without an adequate assessment of community needs, clear goals or a defined plan of action. This panel will provide solid "how to" steps to develop and implement a plan of action to enhance the benefits your organization provides within your communities.
1:45 PM - Break
2:00 PM - Health Insurance and its Role in Health Care Delivery and Charitable Hospitals Panel Discussion Although the American health care system has been said to provide the best quality health care to the majority of our citizens, there is a growing disparity in access to health care because of soaring medical costs, rising insurance premiums, and long term health care insurance spirals. This is particularly true in Texas. This panel will discuss these issues and provide some innovative solutions to these critical concerns.
2:45 pm - Health Care Delivery Trends Panel Discussion Health care delivery can come in a variety of shapes and sizes. This panel will address recent health care trends, such as retail clinics, and the effect these trends have on more traditional health care models. Are the new models providing a service that was missing in the health care arena? Are these models providing patients with convenient, transparent, affordable access to health care? Or is the retail clinic patient in jeopardy due to the lack of consistency that is offered in the family practice model? This panel will also address the structure, failures and successes of select international delivery models.
3:45 PM - Break
4:00 PM - New Federal Reforms for Charitable Hospitals The IRS recently completed the largest overhaul of the Organization Exempt Form Income Tax Form 990 tax return in over 25 years providing additional requirements for nonprofit hospitals. Both the IRS and Congress are actively examining how nonprofit hospitals fulfill their public purpose warranting tax-exempt status. Commissioner Miller will give us an overview of how these changes will affect charitable hospitals in Texas.
The New York Times has an article (Millions With Chronic Disease Get Little to No Treatment) today about the most recent Annals of Internal Medicine survey (abstract) of just exactly what health care services the uninsured with chronic conditions aren't getting. Here's a brief excerpt:
The study, the first detailed look at the health of the uninsured, estimates that about one of every three working-age adults without insurance in the United States has received a diagnosis of a chronic illness. Many of these people are forgoing doctors’ visits or relying on emergency rooms for their medical care, the study said.
The report, based on an analysis of government health surveys of adults ages 18 to 64 years old, estimated that about 11 million of the 36 million people without insurance in 2004 — the latest year of the study — had received a chronic-condition diagnosis.
“These are people who, with modern therapies, can be kept out of trouble,” said Dr. Andrew P. Wilper, the study’s lead author. Therapies for someone with diabetes and hypertension “are routine and widely available, if you have insurance,” said Dr. Wilper, a medical instructor at the University of Washington in Seattle.
The most recent government estimate of the number of people in this country without health insurance is 47 million, which means that if the proportions found in the study have remained constant, there might be nearly 16 million people in this country with a chronic condition but no insurance to pay for medical care.
Nearly a quarter of the uninsured with a chronic illness who were surveyed said they had not visited a health professional within the last year. About 7 percent said they typically went to a hospital emergency room for care.
Tim Walters filed this op-ed piece Saturday in the Cleveland Plain Dealer: All hospitals have to pull their weight on uncompensated care. Seems MetroHealth, the nationally recognized public hospital in town, is in perilous financial condition. It is the largest provider of uncompensated health care in the state of Ohio, and if it goes under, Walters wonders what will happen to indigent patients whose medical home is MetroHealth, not to mention everyone in the community who relies on MetroHealth's unique capabilities (the area's only Level I trauma unit, trauma burn care, etc.).
Walters' answer: Before this happens, how about all the hospitals in the area stepping up to the line and shouldering their fair share of charity care? Of course, hospitals with emergency departments have their EMTALA obligation to screen and to stabilize, but the lion's share of ED admissions and nonemergency charity care is coming from MetroHealth, not University Hospitals (can you spot the ED -- or the maze you have to solve -- on their interactive map?) or the Cleveland Clinic (same question).
Total win for Presbyterian/THR/ 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.
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 . . .
The Wall Street Journal's Law Blog has an entry today on a criminal case brought against a physician at the Harvard School of Public Health. The case is described a little more fully in the Boston Globe. According to the Globe story, the physician -- Dr. Rapin Osathanondh -- was performing an abortion on a 22-year-old woman who died during the procedure. Dr. Osathanondh was subsequently charged by the state medical board with unprofessional conduct, on the basis of these allegations:
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.
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.
Marc Rodwin, one of the most innovative and consistently interesting health law scholars around, has published (with others) in the May/June issue of Health Affairs a very useful study of med mal premiums in Massachusetts (described as "a high-risk state") over the 30-year period of 1975-2005. Here's the abstract:
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.
Not exactly what the AMA would have you believe . . . .
The ACP's new report, E-Health and Its Impact on Medical Practice, is presented on their news page. The challenge of moving physicians to electronic health records is daunting. This is from the press release:
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.
The New York Times had an interesting article Friday (In New York City, Two Versions of End-of-Life Care) on variations in end-of-life care -- not the usual comparison of EOL expenditures between geographically disparate locations, but this time between well-off private hospitals and public facilities a couple of miles apart within the same city. The data come from the Dartmouth Atlas of Health Care. The Times article suggests that "more" is not necessarily "better" and explores some of the reasons -- primarily structural and financial -- behind the disparities.
The Wall Street Journal ran a chilling Page One story yesterday: Cash Before Chemo: Hospitals Get Tough (link may require paid subscription). Here's a little video teaser:
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.
This Tuesday, "Frontline" takes a look at the U.S. health care system by comparing what we have against other countries who manage to provide better access and produce better outcomes at a lower cost. Here are three preview clips:
Here's the press release on the program:
FRONTLINE presents SICK AROUND THE WORLD Tuesday, April 15, 2008, at 9 P.M. ET on PBS
FRONTLINE 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."
Paul Krugman's excellent op-ed yesterday -- Health Care Horror Stories - New York Times -- ought to be required reading across the country. There is plenty to debate about how to fix our health care system, and he's made it clear in past columns that he favors Hillary's universal-coverage-now over Obama's phased-in plan. And there is still debate (here and here) about whether the opening story in the column was accurately described out on the hustings by Hillary (and by Krugman, who repeats a version of it in his op-ed). But isn't it time for an end to the debate over whether our system is broke? Here are a few take-aways from his 700-word column:
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.
It seems that UCLA Medical Center had a serial HIPAA violator on its payroll (until he or she was fired last year for checking out Britney Spears' medical record). See: More UCLA records abuses - Los Angeles Times. We knew this was wrong even before HIPAA, didn't we?
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
Seton Hall Law School’s Center for Health and Pharmaceutical Law and the Seton Hall Law Review will be hosting a symposium on October 23-24, 2008, to examine the legal, ethical, and public policy issues related to developing a pharmaceutical response to a pandemic influenza. Panels will explore issues related to the development and approval of vaccines and antiviral drugs, both before and during a pandemic; the allocation of vaccines and antiviral drugs in situations of scarcity; pricing issues; and liability and compensation for drug-related injuries. There will also be a special emphasis on issues related to international equity.
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.
In my Law, Literature and Medicine class, the poem "Gaudeamus Igitur" by John Stone -- eminent cardiologist and medical educator and poet-essayist par excellence -- is always a hit (you can listen to an NPR story that includes a snippet of the poem). It was written as a graduation valedictory at the Emory University School of Medicine, and it provides a wonderful review of the medical school years, as well as the exhilaration and nervousness that mark the passage from medical student to medical intern. (That would be a tall enough task, but Stone makes it even harder on himself by using as his template for the poem Christopher Smart's bizarre and wonderful celebration of his cat, Jeoffry, in "Jubilate Agno.") One of the class's favorite couplets is this:
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
The "placebo effect" has been much discussed in the medical literature (abstract), including the ethics of misleading patients into believing that they are receiving a medicine with active ingredients when they are, in fact, receiving a placebo. (There has also been a lively debate on the ethics of sham, or placebo, surgery.) The consensus seems to be that there is a placebo effect when the condition is mediated by the brain -- pain being the best example -- and the placebo has never been established when the condition involves a physical abnormality, such as a tumor. And in the realm of pain control, there seems to be a split between practitioners' beliefs and actions on the one hand (many seem to think prescribing a placebo is a good thing) and the ethics literature on the other.
All of this came back to me while reading a story in Wednesday's New York Times about a study published in this week's JAMA (extract only) in which researchers showed that more expensive placebos produced better results than cheaper ones. The really interesting part of this story isn't what it tells us about the psychopharmacokinetic (if there is such a word) effect of placebos. Of even greater interest is this: "The finding may explain the popularity of some high-cost drugs over cheaper alternatives, the authors conclude. It may also help account for patients’ reports that generic drugs are less effective than brand-name ones, though their active ingredients are identical."
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.”
It's the punchline to an old joke, but this time it's deadly serious. According to a recent article in Pediatrics (summary; abstract here - full text here), "Black babies with very low birth weights are nearly twice as likely as their white counterparts to be born at New York City hospitals with high risk-adjusted neonatal death rates." The first and last paragraphs of the article's Discussion section are chilling:
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.
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.
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).
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.
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.
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.
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.
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/
OIG Takes Back Power To Investigate Employee Criminal Conduct From FDA -- The Department of Health and Human Services Office of Inspector General (OIG) will no longer share responsibility with the Food and Drug Administration (FDA) for investigating potential criminal misconduct by FDA employees, Inspector General Daniel Levinson said in a September letter to FDA Commissioner Andrew C. von Eschenbach. Full Story
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.
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 . . . .
Scientific American has an on-line interview with Colorado Rep. Diana DeGette, who recently published, "Sex, Science and Stem Cells: Inside the Right Wing Assault on Reason" (Congresswoman Slams Religious Right's Assault on Science's "Edgier" Side). Here's their intro:
Marc Rodwin
