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
Friday, May 25, 2018
Hoping to visit this blog more than once every four years!
Wednesday, May 28, 2014
American University's 7th annual Health Law & Policy Summer Institute
“American University Washington College of Law’s 7th annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and one online course. Faculty and guest lecturers bring tremendous experience, and courses are designed to combine both theory and practice so that participants gain a well-balanced understanding of each topic. All of the courses are open to law students and lawyers, and several are open to non-attorneys as well. This year’s courses focus on a variety of topics, including pharmaceutical law, bioethics, healthcare fraud and compliance, healthcare antitrust, and the economics of healthcare reform. To learn more about the Institute, please visit http://www.wcl.american.edu/health/institute/ or contact health@wcl.american.edu."It looks like a terrific line-up of courses and knowledgeable speakers. Thank you, Matt, for bringing this to my attention.
P.S. As careful readers of this blog will no doubt have noticed, it's been four years since the last post to this blog. This one instance of breaking radio silence may (or may not) be the rebirth of this blog. Time will tell . . . .
Friday, December 31, 2010
Sunday, September 27, 2009
Dallas Morning News' excellent series on health care costs (and other things that matter)
Sun., 9/27: High prices, red tape fuel popular Dallas doctor's move to Temple
Sun., 9/27: Focus on cost efficiency, quality pays off for Temple-based Scott & White Healthcare
Sun., 9/27: No country has perfect system, but there are lessons to learn
Wed., 9/23: Critics see home health care boom as wasteful, but others tout benefits
Tue., 9/22: Cost of Care: Medical imaging a growth industry, but some say unneeded scans increase expenses
Mon., 9/21: Cost of Care: Doctor-owned hospitals a lucrative practice, though opinions split on benefits
Mon., 9/21: Cost of Care: Baylor Medical Center at Frisco poised to net big payoff for doctor-investors
Sun., 9/20: Cost of Care: Dallas sees no relief in health care expenses as competition drives up costs
Sun., 9/20: Feeling no relief in Dallas: City outspends most on medical care
Patients' stories:
Regional disparities in Medicare spending: http://www.dartmouthatlas.org/interactive_map.shtm
High prices, red tape fuel popular Dallas doctor's move to Temple
Sunday, March 29, 2009
I think Obama's initial emphasis on cost-control is smart - it's by no means clear that the U.S. can afford universal coverage at this point, and even if we tried, the effort would be doomed if unsustainable cost increases aren't also addressed. But eventually, in order for cost control to work, 49 million or so uninsured are going to have to get coverage:
Universal coverage should itself bring down costs over the long run by preventing chronic disease and reducing the amount of non-urgent care provided in emergency rooms. But it requires increased government spending in the form of subsidies for those who cannot now afford coverage.
Obama is starting to address access by focusing on kids first, which is politically astute and humane, and he will presumably expand public programs and public subsidies for private insurance incrementally.
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.”