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
Though I've mellowed on that subject since writing my first article about tax exemption for nonprofit hospitals 20 years ago, when I read stories like this one in the Wall Street Journal (subscription required), detailing how Ascension Health is closing inner-city facilities that lose money in favor of massive investment in suburban hospitals that generate profits (complete with widescreen TV's in private rooms!), I begin to think that any hospital that (1) does not qualify as an educational organization (e.g., a university-affiliated teaching hospital) or (2) does not PRIMARILY serve the poor (an inner-city hospital or perhaps some rural hospitals that are the only source of health care services in their geographic area) ought to be denied exempt status. Let Ascension Health, which reported aggregate net operating revenues of over $500 million last year, pay taxes like any other big business. Which is what it really is.
Preparing for a Pharmaceutical Response to Pandemic Influenza: A Seton Hall Law Review Symposium
October 23-24, 2008 Seton Hall University School of Law Newark, NJ
Co-Sponsored by The Center for Health & Pharmaceutical Law and the Gibbons Institute of Law, Science & Technology at Seton Hall University School of Law Newark, New Jersey
Seton Hall Law School’s Center for Health and Pharmaceutical Law, the Health Law & Policy Program, the Gibbons Institute of Law, Science & Technology, and the Seton Hall Law Review will host a symposium to examine the legal, ethical, and public policy issues related to developing a pharmaceutical response to an influenza pandemic. 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; and issues related to international equity.
The Symposium welcomes all students, faculty members, government officials, pharmaceutical industry representatives, healthcare professionals, and members of the general public.
Cary Grant is supposed to have said it's cheaper in the long run to buy the best shoes possible -- they will hold up better, last longer, look better over time than the supposedly less expensive alternative. It turns out that health care may work the same way. Here are the opening paragraphs of a Bloomberg News story posted yesterday (and brought to my attention by a student in my health law class):
Ken Ferguson, 54, maintains the bulldozers and heavy trucks that haul coal at the Belle Ayr mine near Gillette, Wyoming. In return, his employer, Foundation Coal Holdings Inc., provides his family with the best medical care it can buy.
Ferguson's wife, Shanna, had her colon removed last year because of chronic inflammatory disease. Foundation sent her 700 miles away to the top-ranked Mayo Clinic in Rochester, Minnesota. The company covered the $85,000 bill for the operation and follow-up reconstructive surgery and even paid for Ken's motel.
"I was at the best place with the best doctors possible,'' said Shanna, 50. "And we saved money.''
So did Foundation. The coal producer says it has found an unconventional way to cut health costs: Seek out the nation's best care and give workers incentives to use it. About two-thirds of operations have proven to be cheaper at better-rated hospitals out of state. Even when the price was higher, the Linthicum Heights, Maryland-based company saved money by reducing misdiagnoses, complications and repeat procedures.
Health-care costs for an average employee at Foundation's two Wyoming mines have dropped about 5 percent a year since the program took full effect in 2005, while U.S. spending rose about 7 percent annually. As Foundation's Wyoming workforce grew, its total medical bills remained steady at about $5.5 million a year.
The Kaiser Network has picked up on a report from Reuters that Amerigroup has settled a qui tam whistleblower suit in which it was accused of denying coverage to Medicaid beneficiaries who were pregnant or had health problems. (Under the law, Amerigroup was obligated to provide coverage for a Medicaid enrollees.)
Amerigroup claims its enrollment practices were intended to meet the objections of state officials that it was enrolling too many women who were late in their pregnancies. A jury rejected that claim and found instead that the insurer had engaged in systemic and wide-ranging fraud. The settlement occurred while Amerigroup's appeal from the 2006 judgment for $334 million was pending. The qui tam relator, former Amerigroup employee Cleveland Tyson, will walk away with a cool $56.3 million, his share of the recovery under the federal civil False Claims Act.
Forget the legal niceties for just a moment. Set aside the company's self-serving statements about needing to put this matter behind them and to move for the good of the company and its shareholders. And postpone thoughts that this sorry episode is a staggering example of the internal conflict of interest that plagues all health insurers.
Think instead of the extent of the human misery Amerigroup caused by denying coverage under this corporate policy. After the judgment was reduced by $109 million as a result of the settlement, it was still the largest health fraud recovery in Illinois' history (see Ill. AG's news release), and deservedly so.
Today The Washington Post has an article -- Infant Transplant Procedure Ignites Debate -- that builds on yesterday's AP article about three cases in which infant hearts were harvested under a "donation after cardiac death" ("DCD") protocol, which all transplant centers are required by UNOS and HHS. The details of each center's protocol may vary.
On the crucial issue of how long to wait before death is declared following the removal of life support and the onset of pulselessness, the Children's Hospital of Denver team waited 75 seconds in two of the cases and 3 minutes in the third; most centers' protocols require either 2 minutes or 5. Part of the ethical debate turns on whether this is long enough to be assured that autoresuscitation won't occur, a key component in determining that the absence of cardiac function is total and irreversible. Not to put too fine a point on it, if autoresuscitation can't be ruled out, irreversibility can't be assured, and if the loss of cardiac function isn't irreversible according to reasonable medical standards, the infant donors can't really be said to have died.
A second part of the debate concerns the removal of hearts from patients who haven't been declared brain dead. Most protocols of which I am aware are limited to kidneys; some include other organs, but I am not aware of any others that permit the harvesting of thoracic organs, hearts in particular. Think about it: If the heart's ability to beat (which is in some sense "intrinsic" because it is not tied to brain function) is supposedly irreversible, how can that be true when the heart (in all three cases) is working perfectly well in other bodies three years later? Two conclusions seem inescapable: The donor babies were erroneously declared dead and the traditional "dead donor rule" was abandoned
The debate was prompted by one clinical report, three Perspective pieces, and an editorial in today's New England Journal of Medicine, plus a videotaped discussion among three ethicists. It's unusual for the NEJM to devote this must space to any single topic. Even more unususal -- and a sign of how seriously they take the issues raised by the clinical report -- is their decision to make all five pieces available in full text (rather than abstracts only) for free:
How to pick a life partner, 2008-style: "Let's see. . . . Good personality? Check. Kind to small animals and young children? Check. Reasonably communicative and okay with intimacy? Check. Excellent health care insurance? DOUBLE CHECK!!" That's the message in yesterday's New York Times article, Health Benefits Inspire Rush to Marry, or Divorce.
It's a sign of the times. As HLS Prof. Elizabeth Warren has written, "Every 30 seconds in the United States, someone files for bankruptcy in the aftermath of a serious health problem." (See also her SSRN article on this topic.) Insurance coverage is no guarantee that a person won't financially devastated by illness:
Nobody's safe. That's the warning from the first large-scale study of medical bankruptcy.
Health insurance? That didn't protect 1 million Americans who were financially ruined by illness or medical bills last year.
A comfortable middle-class lifestyle? Good education? Decent job? No safeguards there. Most of the medically bankrupt were middle-class homeowners who had been to college and had responsible jobs -- until illness struck.
As part of a research study at Harvard University, our researchers interviewed 1,771 Americans in bankruptcy courts across the country. To our surprise, half said that illness or medical bills drove them to bankruptcy. So each year, 2 million Americans -- those who file and their dependents -- face the double disaster of illness and bankruptcy.
But the bigger surprise was that three-quarters of the medically bankrupt had health insurance.
How did illness bankrupt middle-class Americans with health insurance? For some, high co-payments, deductibles, exclusions from coverage and other loopholes left them holding the bag for thousands of dollars in out-of-pocket costs when serious illness struck. But even families with Cadillac coverage were often bankrupted by medical problems.
Too sick to work, they suddenly lost their jobs. With the jobs went most of their income and their health insurance -- a quarter of all employers cancel coverage the day you leave work because of a disabling illness; another quarter do so in less than a year. Many of the medically bankrupt qualified for some disability payments (eventually), and had the right under the COBRA law to continue their health coverage -- if they paid for it themselves. But how many families can afford a $1,000 monthly premium for coverage under COBRA, especially after the breadwinner has lost his or her job?
Often, the medical bills arrived just as the insurance and the paycheck disappeared.
Bankrupt families lost more than just assets. One out of five went without food. A third had their utilities shut off, and nearly two-thirds skipped needed doctor or dentist visits. These families struggled to stay out of bankruptcy. They arrived at the bankruptcy courthouse exhausted and emotionally spent, brought low by a health care system that could offer physical cures but that left them financially devastated.
Considering the overwhelming impact medical debt can have on other aspects of domestic life, is it any wonder that domestic life is occasionally getting bent in ways that are intended (regardless of the prospect for success) to keep the wolf from the door.
As the article points out, divorce is also an option that couples will consider in order to qualify one or the other of them for state-provided benefits. (This is an old Medicaid-planning device.) The example that is in the article is compelling:
Other couples, like Michelle and Marion Moulton, are forced to consider divorce so that an ailing spouse can qualify for affordable insurance.
Ms. Moulton, 46, a homemaker who lives near Seattle with her husband and two children, learned three years ago that she had serious liver damage, a side effect, she believes, of drugs she was once prescribed. She is trying to get on a transplant list, but the clock is ticking; her once slender body has ballooned, and her doctors say her liver could give out at any time.
Mr. Moulton, a self-employed painting contractor, maintains a catastrophic coverage plan for his family, but its high deductibles and unpredictable reimbursements have left them $50,000 in debt. Without better coverage, a transplant could add unthinkable sums.
Two years ago, Ms. Moulton looked into buying more comprehensive coverage through the Washington State Health Insurance Pool, a state-financed program for high-risk patients. She found the premiums unaffordable, but noticed that the state offered subsidies to those with low incomes. As their debts and desperation multiplied, it occurred to Ms. Moulton that divorcing her husband of 17 years would make her eligible for the subsidized coverage.
“I felt like I had done this to us,” she said. “We had worked hard our entire lives, and if this was all the insurance we had, we could become homeless. I just said, ‘You know, we really need to sit down and talk about divorce.’ ”
Mr. Moulton would not consider it — at first. “From a male point of view, you want to be able to fix things, you want to be able to provide,” he said.
“Then you start looking at what things cost and what someone with no assets can get in terms of funding, and you have to start thinking about it.”
The conversations ebbed and flowed with the family’s financial pressures. They talked about the effect on their children and where they might live. They weighed the legal and financial risks against the prospects of bankruptcy.
The debate continued until this summer, when Mr. Moulton’s father offered financial help. “I know we don’t take charity from anyone,” Mr. Moulton told his wife, “but I’m not going to divorce you and I’m not going to let you die.”
Though grateful for the lifeline, the couple remains unsettled by how close they came.
“Nobody should have to make a choice like that,” Ms. Moulton said. “What happened to our country? I don’t remember growing up like this.”
The latest from The Commonwealth Fund is a report based upon a Harris Interactive survey that sought the opinions of a sample of 1,004 adults about our health care system. Here's a summary of the results:
Overall, the telephone survey of a representative sample of 1,004 adults age 18 and older reveals that the health care delivery system does not serve the public well — eight of 10 respondents say it needs to be fundamentally changed or completely rebuilt. Many adults experience difficulties accessing care and poor care coordination, and struggle with the administrative hassles and complexity of health insurance. In addition, the survey found that one of three adults has experienced inefficient or unnecessary care in the past two years. Adults want their health care to be more patient-centered and integrated, and see an important role for information technology and teamwork in improving care. Reflecting these shared concerns, there is strong support for the next president to address health care quality, coverage, and costs.
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.
Excellent discusion by John Colombo over at Nonprofit Law Prof Blog, ostensibly about the recent GAO report, Nonprofit Hospitals: Variation in Standards and Guidance Limits Comparison of How Hospitals Meet Community Benefit Requirements (GAO 08-880), but also about current thinking as to whether nonprofit hospitals should be tax-exempt in the first place. His conclusion:
Marc Rodwin
