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
Thursday, December 18, 2008
Dallas Morning News: series on palliative care
Wednesday, December 17, 2008
WSJ backs incentives for organ donation
The Journal doesn't say much about Specter's bill, other than that it would retain the ban on valuable consideration being paid for organs and increase the criminal penalties for violating the prohibition (both of which contradict the Journal's call for a market), but they seem to think the bill is a step in the right direction. But Specter appears not to have introduced the bill yet, nor has he described it in remarks from the floor of the Senate or posted so much as an outline of it on his Senate web site.
A columnist at the N.Y. Sun, Diana Furchtgott-Roth,, claims to have seen the three-page bill, or a summary of it. On September 24 she wrote:
according to the bill's summary, it would "increase the supply of donated organs by clarifying the legality of both government incentives that honor the gift of life and payments associated with the screening, pretransplantation care, and follow-up care expenses incurred by living organ donors." Both states and charities would be allowed to pay these expenses.Ms. Fuchtgott-Roth adds: "As states sort out these issues, there are a variety of ways that they could permit compensation, such as funeral expenses, payments to an IRA, tuition or tax credits, or health insurance. One potential benefit to encourage donations would be to put donors and their families at the top of the list to receive kidney donations from others, should a future need arise."
In a December 4 post on the Encyclopedia Britannica Blog, John J. Pitney, Jr., writes that Specter is circulating a draft of his bill, the Organ Donor Clarification Act of 2008. If anyone has a copy, I'd love to see the "clarifying" language.
Meanwhile, Sally Satel, M.D., a resident scholar at the American Enterprise Institute, has a book coming out next month -- When Altruism Isn't Enough -- in which she and others make the case for economic incentives to encourage organ donation. Here's the AEI website's blurb:
It's already on my list for 2009. For those who can't wait that long, AEI has some of her articles on the subject posted on their website:America faces a desperate organ shortage. Today, more than 78,000 people are waiting for a kidney transplant; only one in four will receive one this year, while twelve die each day waiting for help. Not surprisingly, many patients are riven to desperate measures to circumvent the eight-year waiting list--renting billboards, advertising in newsletters, or even purchasing an organ on the global black market. Altruism is an admirable but clearly insufficient motivation for would-be donors.
What can be done to solve the kidney crisis? Reward organ donors for their remarkable gifts. Noncash benefits to people who donate to a desperate stranger will motivate others to do the same, increase the national supply of kidneys, and reduce needless death and suffering. When Altruism Isn't Enough: The Case for Compensating Kidney Donors explores the key ethical, theoretical, and practical concerns of a government-regulated donor compensation program. It is the first book to describe how such a system could be designed to be ethically permissible, economically justifiable, and pragmatically achievable.
Altruism is a beautiful virtue, but relying on it as the sole impetus for organ donation ensures that thousands of people will continue to die each year while waiting for kidney transplants.
Sally Satel, MD, is a resident scholar at the American Enterprise Institute.Contributors: David C. Cronin II, MD, Julio J. Elias, Richard A. Epstein, Michele Goodwin, Benjamin E. Hippen, MD, Elbert S. Huang, MD, Arthur J. Matas, MD, David O. Meltzer, MD, Sally Satel, MD, Mary C. Simmerling, James Stacey Taylor, Nidhi Thakur, Chad Thompson.
- Satel & Benjamin Hippen, M.D., Forbes, Oct. 30, 2008
- Satel, Slate, August 18, 2008
Finally, let's recall that last December Congress itself amended the prohibition-of-organ-sales provision in the National Organ Transplant Act (42 U.S.C. 274e) to make it clear that the law doesn't prohibit paired organ exchanges (Pub. L. No. 110-144, 121 Stat. 1813). The amendment codified the conclusion of a DOJ Memorandum Opinion that paired organ exchanges are not a form of "valuable consideration" in violation of the Act. Although, with the amendment, the point is now moot, I disagreed with DOJ on this, although I approved its conclusion on pure policy grounds. (In brief, if B, the spouse of patient A , isn't a good match with A but is a good match for patient C, and C's spouse, D, is a match for patient A, and B agrees to donate a kidney to Patient C in return for D's promise to donate a kidney to patient A, I think the exchange of promises -- and certainly the exchange of kidneys -- is valuable consideration. Not that there should be anything wrong with that . . . . )
Whatever evil Congress had in mind when it enacted the prohibition, this couldn't have been it, but it does open the door ever so slightly to at least some kinds of valuable exchanges. Based on what I've read about Sen. Specter's bill-to-be, the states ought to be able to craft their own benefit packages to create incentives without risking the commodification of the body and coercing desperate poor people into donating their organ in order to put food on the table.
Friday, December 12, 2008
Vatican issues 3rd major bioethics pronouncement in 21 years
Wednesday, December 03, 2008
Cleveland Clinic addresses financial conflicts of interest head-on
The public reporting will be pretty minimal, at least at first, but the Cleveland Clinic gets points for getting out in front on this issue. Expect other research/treatment centers to follow suit. Charles Grassley and his colleagues on the Senate Finance Committee will be going after academic medical centers and others to deal with financial conflicts openly, and major drug firms like Merck and Lillyhave already announced their intention to publicly disclose payments to physicians next year.publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers.
The clinic, one of the nation’s most prominent medical research centers, is making a complete disclosure of doctors’ and researchers’ financial ties available on its Web site, http://www.clevelandclinic.org/.
It appears to be the first such step by a major medical center to disclose the industry relationships of individual doctors. And it comes as the nation’s doctors and hospitals are under mounting pressure to address potential financial conflicts of interest that can occur when they work closely with companies to develop and research new drugs and devices.
Wednesday, November 26, 2008
13-year-old refuses heart transplant
Sunday, November 23, 2008
Larry Gostin's "Public Health Law" text in new edition
Thursday, November 20, 2008
Health insurers agree to drop pre-existing condition exclusion
Sunday, November 09, 2008
Washington passes PAS ballot measure
Monday, November 03, 2008
More than two-thirds of respondents to the latest Commonwealth Fund/Modern Healthcare Health Care Opinion Leaders Survey believe the way we pay for health care in the United States must be fundamentally reformed. Fee-for-service payment--the most prevalent system throughout the country--is not effective in encouraging high-quality, efficient care, they say.
In the survey, there was strong support for a move away from fee-for-service payment toward bundled approaches--that is, making a single payment for all services provided to a patient during the course of an episode or period of time. Under fee-for-service, providers are reimbursed for individual services, like hospital stays and medical procedures, rather than for providing the most appropriate care for the patient over the course of an illness. This creates incentives for providing more technical and more expensive--but not necessarily more effective -- care.
When asked their opinions about policies for improving U.S. health system performance, 85 percent of survey respondents cited fundamental provider payment reform, including incentives to provide high-quality and efficient care over time, as an effective strategy.
Monday, October 20, 2008
Tax-exempt hospitals and "community benefit"
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.
Wednesday, October 15, 2008
Seton Hall Law Review Symposium
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
The Symposium welcomes all students, faculty members, government officials, pharmaceutical industry representatives, healthcare professionals, and members of the general public.
Admission is free.
Register online at: http://law.shu.edu/pandemic.
Saturday, September 27, 2008
Pay for the best care, save money
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.
Monday, August 18, 2008
Insurer to pay $225M settlement in Medicaid coverage-denial suit
Thursday, August 14, 2008
Pediatric DCD in the news
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:
Clinical report:
- Pediatric Heart Transplantation after Declaration of Cardiocirculatory Death M. M. Boucek and Others
FREE Full Text PDF
Perspectives:
- The Boundaries of Organ Donation after Circulatory Death
J. L. Bernat
FREE Full Text PDF Perspective Roundtable - Donating Hearts after Cardiac Death — Reversing the Irreversible
R. M. Veatch
FREE Full Text PDF Perspective Roundtable - The Dead Donor Rule and Organ Transplantation
R. D. Truog and F. G. Miller
FREE Full Text PDF Perspective Roundtable
Editorial:
- Cardiac Transplantation in Infants
G. D. Curfman, S. Morrissey, and J. M. Drazen
FREE Full Text PDF Perspective Roundtable
The video discussion is here (requires Flash), along with a transcript.
Wednesday, August 13, 2008
"For better or worse, for richer or poorer, in sickness and in health . . . "
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:
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.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.
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:
Good question. What happened to our country?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.”
Thursday, August 07, 2008
U.S. health care reform: can 8 out of 10 Americans be wrong?
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.
Wednesday, August 06, 2008
Congresswoman Slams Religious Right's Assault on Science's "Edgier" Side
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.
New Study Looks at Uninsurance Among Immigrants
[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).
Latest health-related reports from GAO
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-954
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-668
Hurricane Katrina: Trends in the Operating Results of Five Hospitals in New Orleans before and after Hurricane Katrina.
GAO-08-681R, July 17, 2008 (56 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-681R
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-727
Indian Health Service: Mismanagement Led to Millions of Dollars in Lost or Stolen Property and Wasteful Spending. GAO-08-1069T, July 31, 2008 (10 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-1069T
2008 (47 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-539
Long-Term Care Insurance: Oversight of Rate Setting and Claims Settlement Practices. GAO-08-712, June 30, 2008 (35 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-712
Long-Term Care Insurance: State Oversight of Rate Setting and Claims Settlement Practices. GAO-08-1016T, July 24, 2008 (19 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-1016T
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
Medicare Part D: Complaint Rates Are Declining, but Operational and Oversight Challenges Remain. GAO-08-719, June 27, 2008 (34 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-719
Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-Label Uses. GAO-08-835, July 28, 2008 (41 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-835
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-675
GAO-08-805, June 30, 2008 (39 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-805
Veterans Health Administration: Improvements Needed in Design of Controls over Miscellaneous Obligations. GAO-08-1056T, July 31,
2008 (32 pages).
http://www.gao.gov/docdblite/details.php?rptno=GAO-08-1056T
Texas Attorney General: Charitable Hospital Summit
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 Texas12:45 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.
Tuesday, August 05, 2008
What it means to be uninsured in America
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.
Sunday, July 27, 2008
All hospitals have to pull their weight on uncompensated care
Wednesday, July 23, 2008
5th Circuit's decision in Poliner is out
medical-staff docs. HCQIA immunity for money damages held to apply to emergency suspension decisions during the fact-investigation phase of the peer-review process. Judge Higginbotham's opinion for a unanimous panel is here. It looks bullet-proof to me . . . . Pretty amazing saga, which I am sure won't be over until there's a petition for reconsideration/rehearing en banc: from a $360-million jury verdict to a remitted judgment for $33 million (still amazing for peer-review case) to $0.
Monday, July 21, 2008
Trying to Save by Increasing Doctors’ Fees
That's the headline in this morning's New York Times' story about health plans (including Medicare) that are going to try to gin up some extra compensation for primary and preventive care in the hope that it will reduce more costly acute care down the road. Could it be? The dawning of the Age of Common Sense? Stay tuned . . .
Thursday, July 17, 2008
Making Malpractice a Criminal Matter
The board alleged that Osathanondh had placed the patient under sedation without any means to monitor her heart rate, blood pressure, or the oxygen level of her blood. The board said the doctor had no qualified person assisting him while Smith was under anesthesia. The only other person in the room was an office worker who had no CPR or other training in lifesaving procedures.
The board added that Osathanondh "failed to timely initiate a call to 911," "failed to maintain an adequate airway," and "failed to adhere to basic cardiac life support protocol."
Osathanondh also allegedly made a variety of false statements to board investigators, telling them that he had administered Smith oxygen and monitored her oxygen levels and that his office worker was certified in lifesaving procedures. He allegedly tried to deceive investigators by expanding the size of his treatment room and bringing in new equipment, which he maintained was there at the time of the abortion.
While it is rare for allegations of medical malpractice to be channeled through the criminal justice system, it's not unheard of. There's a point at which ordinary negligence shades into gross negligence (which can still be handled in the tort system) and at which gross negligence evidences the kind of recklessness that qualifies as a criminal offense. I am not competent to have an expert opinion about what happened in this case, but the cries of outrage about this case resulting in a criminal prosecution are a bit overdrawn. Extreme negligence -- multiple departures and wild departures from the standard of care -- if proved, can properly be a matter for the criminal justice system whether the defendant is a nightclub owner who locks the fire exits (resulting in hundreds of deaths after a fire breaks out) or a member of the medical profession.
Sunday, June 15, 2008
The vaccine-autism debate: a lecture
THE VACCINE-AUTISM DEBATE:WHY WON'T IT GO AWAY?
David Kirby, AuthorEvidence of Harm - Mercury in Vaccines and the Autism Epidemic: A Medical Controversy
Thursday, June 26, 20086:30 - 9:00 PM
NYU School of Law 40 Washington Square South,Vanderbilt Hall, Room 204
RSVP REQUIRED: kirbylecture@gmail.com
FREE AND OPEN TO THE PUBLIC
David Kirby, investigative journalist and author of the New York Times bestseller, Evidence of Harm, will address contemporary legal, scientific and political aspects of the vaccine-autism debate.
Kirby is a former contributor to The New York Times and a regular writer for the The Huffington Post. Mary Holland, NYU Director of the Graduate Legal Skills Program, will introduce Mr. Kirby and moderate the Q&A. Information on Evidence of Harm is at http://www.evidenceofharm.com/ Kirby's Huffington Post essays may be viewed at www.huffingtonpost.com/david-kirby.
Saturday, May 31, 2008
Med mal premiums in Mass., 1975-2005
Massachusetts has the fourth-highest median malpractice settlement payments for all states. The American Medical Association (AMA) declares it a crisis state. As a test case, we analyzed its premiums from 1975 to 2005. In 2005 mean premiums were $17,810 for the coverage level and policy type most frequently purchased. Most physicians paid lower inflation-adjusted premiums in 2005 than in 1990. Mean premiums increased in only three specialties comprising 4 percent of physicians: obstetrics, neurology, and orthopedists–spinal surgery. However, because of discounts and surcharges, in 2005 premiums within the three highest-risk specialties varied nearly threefold, and nearly one-third paid less than in 1990.
American College of Physicians: E-Health Recommendations
Health care may be the fastest growing industry, but it has been slow to adopt the use of technology. While orders at fast food chains are now entirely automated, most physician offices and hospitals still maintain their records on paper.
In [the ACP's] new position paper . . . , the nation’s largest medical specialty organization says that collaboration among physicians, patients, technology developers, and policymakers must occur if e-health activities like electronic communication between physicians and their patients, remote monitoring of patients, personal and electronic health records, and patients seeking health information online are to transform health care in the U.S.
In other words, don't hold your breath.
Two Versions of End-of-Life Care
Tuesday, April 29, 2008
Cash Before Chemo
Once again, it's all too easy in the U.S. system to find yourself underinsured for a serious illness, and when you're underinsured, you might as well be uninsured.
Sunday, April 13, 2008
PBS Frontline: "Sick Around the World"
FRONTLINE presents
SICK AROUND THE WORLD
Tuesday, April 15, 2008, at 9 P.M. ET on PBSFRONTLINE TRAVELS TO FIVE COUNTRIES IN SEARCH OF A UNIVERSAL HEALTH CARE SYSTEM THAT COULD WORK IN THE U.S.
FRONTLINE teams up with T.R. Reid, a veteran foreign correspondent for The Washington Post, to find out how five other capitalist democracies--United Kingdom, Japan, Germany, Taiwan and Switzerland--deliver health care and what the United States might learn from their successes and their failures. In Sick Around the World, airing Tuesday, April 15, 2008, at 9 P.M. ET on PBS (check local listings), Reid turns up remarkable differences in how these countries handle health care--from Japan,
where a night in a hospital can cost as little as $10, to Switzerland, where the president of the country tells Reid it would be a "huge scandal" if someone were to go bankrupt from medical bills.Reid's first stop is the U.K.--a system very different from ours, where the government-run National Health Service is funded through taxes. According to Whittington Hospital CEO David Sloman, "Every single person who's born in the U.K. will use the NHS ... and none of them will be presented a bill at any point during that time." Reid is surprised to find the system often dismissed as "socialized medicine." The U.K. is now trying free-market tactics like "pay-for-performance," where some doctors are paid more if they get good results controlling chronic diseases like diabetes, and patient choice, in which hospitals compete head to head. While such initiatives have helped reduce waiting times for elective surgeries, the London Times' medical correspondent Nigel Hawkes tells Reid the NHS hasn't made enough progress. "We're now in a world in which people are much more demanding, and I think that the NHS is not very effective at delivering in that modern, market-orientated world."
Reid reports next from Japan, the world's second largest economy and the country boasting the best health statistics. The Japanese go to the doctor three times as often as Americans, have more than twice as many MRIs, use more drugs, and spend more days in the hospital, yet Japan spends about half as much per capita as the United States. Reid finds out the secrets of the nation's success: By law, everyone must buy health insurance--either through an employer or a community plan--and unlike in the U.S., insurers cannot turn down a patient for a pre-existing illness, nor are they allowed to make a profit.
Reid's journey then takes him to Germany, the country that invented the concept of a national health care system. For it's 80 million people, Germany offers universal health care, including medical, dental, mental health, homeopathy and spa treatment. Professor Karl Lauterbach, M.D., a member of the German parliament, describes it as "a system where the rich pay for the poor and where the ill are covered by the healthy. It is ... highly accepted by the population." As they do in Japan, medical providers must charge standard prices which are negotiated with the government every year. As a consequence, physicians in Germany earn between half and two-thirds as much as their U.S. counterparts.
Taiwan researched many health care systems before settling on one where the government runs the financing, but Reid finds the delivery of health care is left to the market. Taiwanese health care offers medical, dental, mental and Chinese medicine, with no waiting time and for less that half of what we pay in the United States. Every person in Taiwan has a "smart card" containing all of his or her relevant health information, and bills are paid automatically. But what Reid finds is that the Taiwanese spend too little to sustain their health care system. According to Princeton's Tsung-Mei Cheng, who advised the Taiwanese government, "As we speak, the government is borrowing from banks to pay what there isn't enough to pay the providers."
Reid's final destination is Switzerland, a country whose health care system suffered from some America's problems until, in 1994, the country attempted a major reform. Despite a huge private insurance business, a law called LAMal was passed, which set up a universal health care system that, among other things, restricted insurance companies from making a profit on basic medical care. Today, Swiss politicians from the political right and left enthusiastically support universal health care. Pascal Couchepin, the president of the Swiss Federation, argues: "Everybody has a right to health care. ... It is a profound need for people to be sure that if they are struck by destiny ... they can have a good health system."
Friday, April 11, 2008
Some basic health-reform lessons
1. Just because you have health insurance today don't assume that means you will have it tomorrow. Employers drop employee health plans when they become too expensive. Bankrupt employers aren't obligated to continue health insurance for retirees, regardless of previous bargained-for promises. Annual and life-time caps on benefits can wipe out future benefits. And plan coverage can be manipulated so that your particular needs are no longer covered.
2. The uninsured are charged more for their health care than the insured. The resulting bad credit and outstanding balances may limit future access to health care.
3. The emergency-room option that is virtually guaranteed by EMTALA and was touted by President Bush as a health-care safety net is no substitute for insurance coverage and access to primary and preventive care. Lots of people delay care until they have a "true emergency" -- they will still be billed for the care they receive, regardless of ability to pay. (In fact, even insured patients have good reason to postpone ER visits, unless they live in a state that requires managed care plans to pay for the ER services, even if there was no true emergency, as long as a reasonable layperson would have thought they had a medical emergency.
4. The lack of universal coverage that every other developed country seems to be able to afford isn't simply an "access" problem. People get sicker, stay sicker longer, and die as a result of care that is postponed or not sought when it could still be useful.
Monday, April 07, 2008
More medical records abuses
Tuesday, March 18, 2008
Law review call for papers: "Preparing for a phamaceutical Response to Pandemic Influenza"
Preparing for a Pharmaceutical Response to Pandemic Influenza
Co-sponsored by the Health Law & Policy Program’s Center for Health & Pharmaceutical Law and the Gibbons Institute of Law, Science & Technology
October 23-24, 2008
Seton Hall Law School
Newark, NJ
Call for Papers
Persons interested in participating as a panelist and/or in publishing a piece in the special symposium issue of the Seton Hall Law Review should submit a CV and a 200-word abstract of their presentation to Julie Sauer, Symposium Editor, by April 15, 2008. Julie Sauer may be reached at (201) 739-7310 / sauerjul@shu.edu. Prospective panelists should indicate whether they would be interested in submitting a paper based on their presentation for publication. Contributions are welcome from scholars and practitioners in all disciplines.
For more information, please visit the Seton Hall Law Review symposium website at http://law.shu.edu/journals/lawreview/symposium2008.htm.
Wednesday, March 05, 2008
For the placebo will work and you will think you know why
For the placebo will have side effects and you will know you
do not know why
Tuesday, March 04, 2008
Are antibiotics futile for nursing home patients with advanced dementia?
This prospective cohort study demonstrates that antimicrobial exposure among nursing home residents with advanced dementia is extensive and steadily increases toward the end of life. During the follow-up period (mean follow-up, 322 days), two-thirds of the subjects were prescribed at least 1 course of antimicrobial therapy and, on average, a total of 4 courses. Among the residents who died, 42.4% received antimicrobials during the last 2 weeks of life, often via a parenteral route. The proportion of residents taking antimicrobials was 7 times greater in the last 2 weeks of life compared with 6 to 8 weeks before death. This extensive use of antimicrobials and pattern of antimicrobial management in advanced dementia raises concerns not only with respect to individual treatment burden near the end of life but also with respect to the development and spread of antimicrobial resistance in the nursing home setting. . . .
Treatment decisions for infections in advanced dementia can be difficult for family members and caregivers. The 2 purported reasons to administer antimicrobials are life prolongation and symptom control. Limited observational studies have failed to demonstrate that antimicrobial treatment achieves either outcome in this frail population; however, randomized trials have not been conducted. Our findings further support that antimicrobials may not meaningfully extend the life of patients with advanced dementia for whom infections are frequently a terminal event. Palliation is often the main goal of care in this condition. It is difficult to assess the extent to which infections cause suffering in patients with advanced dementia. Previous work demonstrates that pneumonia is an uncomfortable experience for these patients and suggests that antimicrobial therapy may improve symptoms. However, it remains unclear whether antimicrobial therapy promotes symptomatic relief beyond what can be achieved by high-quality palliative treatment with more conservative modalities (eg, oxygen and acetaminophen). Finally, it is also important to minimize inappropriate antimicrobial exposure. For example, up to one-third of antimicrobials prescribed in nursing homes are for asymptomatic bacteriuria, for which treatment is not indicated. Antimicrobial administration has associated risks in the frail elderly population that merit consideration. Older persons are particularly susceptible to the adverse effects of antimicrobials owing to altered pharmacokinetics, polypharmacy, dosing errors, and an increased risk of Clostridium difficile infections. Moreover, parenteral administration, which was common in our cohort, can be an uncomfortable procedure in advanced dementia. Thus, from the individual patient's perspective, the balance of advantages and disadvantages of antimicrobial treatment of infections in advanced dementia remains unclear, regardless of the primary goal of care.
On a broader level, the emergence and spread of antimicrobial-resistant bacteria is a major public health concern. Older persons account for one of the largest patient reservoirs of these organisms. In particular, up to 40% of residents living in nursing homes harbor at least 1 species of antimicrobial-resistant bacteria. Once admitted to the hospital, these nursing home residents contribute substantially to the influx and spread of antibiotic-resistant bacteria. Exposure to antibiotics is strongly associated with the development of antibiotic resistance. Quinolones and third-generation cephalosporins were the most frequently prescribed antimicrobials in our cohort. Several studies have reported that more than 50% of isolates recovered from nursing home residents are resistant to these 2 classes of drugs. These observations and the extensive use of antibiotics found in this study raise the serious concern that nursing home residents with advanced dementia may be contributing to the emergence and spread of antimicrobial-resistant bacteria, posing health risks that extend beyond the individual being treated. . . .
Infections and febrile episodes are a hallmark of end-stage dementia. The extensive antimicrobial use demonstrated in this study is concerning given the lack of demonstrable benefits and the potential burdens of treatment in this terminally ill population for whom the goal of care is often palliation. Moreover, we believe that the widespread use of antibiotics in advanced dementia may pose a potential public health risk through the emergence of antibiotic resistance. This hypothesis requires further research. Meanwhile, from individual and societal perspectives, our study supports the development of programs and guidelines designed to reduce the use of antimicrobial agents in advanced dementia.
The accompanying editorial in Archives explictly frames the study in terms of medical ethics generally and "futility" in particular. The editorial poses this question: "If antibiotics are not required to restore comfort to an infected patient (either because the patient is in no distress or because palliation can be achieved by other means) and cannot be expected to enhance duration or quality of life, might not their use be considered futile?," which it then answers, "Prior investigators have indeed come to this conclusion" [footnote omitted]. So far, so good. If the purposes for which antibiotics would be prescribed are not likely to be attained, their use lacks a pathophysiologic rationale, a classic "futility" rationale. This is especially so because there are some negative consequences for the elderly and the overuse of antiobiotics in this population (as in any other) contributes to some degree in the development of antiobiotic resistant bacteria, a significant source of morbidity and mortality in hospitals.
But then the editorialist continues: "Even if antibiotics may prolong life, should they be used if they will not enhance quality of life?" This is a fair question only if it is separated from the issue of "futility." In common parlance, invocation of the "futility" label confers upon the practitioner the moral right to withhold or withdraw a medical intervention, even over the objections of the patient or the patient's surrogate decision maker. If the intervention does have a pathophysiologic rationale (prolongation of life), I would argue that "futility" is no longer the proper ethical framework for the discussion. As with any other intervention that may prolong life without necessarily increasing the quality of life, a discussion with the patient or the surrogate is certainly appropriate. A unilateral decision to withhold the drug(s) (or the discussion) is not. The editorial writer appears to agree with this: "The solution is not to categorically deny antibiotics to the severely demented elderly, or even to impose limits on their use or their spectrum as a matter of policy. Such decisions, in addition to being ethically untenable, would run counter to the expressed wishes of patients and their families. We must, however, begin to consider every decision to use antibiotics in this population as we would decisions regarding other treatment modalities, including resuscitation and major surgery."
According to the Times, Prof. Paul Appelbaum at Columbia sees things the same way: “The apparent suggestion that we should not be treating persons with dementia when they develop infections rests on a normative judgment — that does not flow from these data — that their lives are worth less than the unknown degree of risk of contributing to antibiotic resistance. Although one cannot ask the patients themselves how they feel about this judgment, many of their family members and caregivers would disagree, and our society — fortunately, in my view — has not yet reached the point where it is willing to embrace it.”