January 28, 2005
Study on Fidgeting and Weight Loss
The Washington Post reports on a recent study by researchers at the Mayo Clinic that shows that people who fidget burn about 350 more calories a day! The Post reports,
"The most detailed study ever conducted of mundane bodily movements found that obese people tend to be much less fidgety than lean people and spend at least two hours more each day just sitting still. The extra motion by lean people is enough to burn about 350 extra calories a day, which could add up to 10 to 30 pounds a year, the researchers found.
'There are these absolutely staggering differences between people who are lean and people who are obese," said James A. Levine of the Mayo Clinic, who led the research published in today's issue of the journal Science. "The amount of this low-grade activity is so substantial that it could, in and of itself, account for obesity quite easily.'"
NPR's All Things Considered has a very detailed story on this study. Participating in the study did not sound like much fun - the participants had to wear special underwear with sensors to monitor all body moverments. A picture of the underwear may be found at the NPR website. [bm]
Health Law Professor Sues for Discrimination
This item comes from Brian Leiter's Blog, Leiter Reports (always an interesting and informative read). He provides an overview of Professor Peter Hammer's complaint against the University of Michigan School of Law for discrimination against him as an openly gay man. Professor Leiter also provides links to the complaint and some observations about current and past tenure practices at law schools. [bm]
Upcoming Global Health Conference
The University of Washington School of Law Global Health and Justice Project and the Pactific Northwest enter for Health, Law and Policy are hosting a conference concerning international law, patent law and human rights issues impact health law in the United States. The conference will focus on such questions as: What are the pupoulations that are most at risk of human rights abuses and how does this affect individual and population health? Does patent law really impact access to medical innovations, including new pharmaceuticals? How do trade and trade law affect our health? Featured speakers include Leonard S. Rubenstein, the Executive Director of Physicians for Human Rights, and Sofi Grustkin, the Director of the Program on International Health and Human Rights at Francois-Xavier Bagnoud Center for Health and Human Rights.
The conference will be held February 25-26, 2005. For more information, click here. [bm]
January 27, 2005
Leavitt Confirmed as HHS Secretary
Mike Leavitt was unanimously confirmed yesterday by the Senate for the top post at Health and Human Services (HHS). He should face some fairly tough issues, including the alleged Medicare and Medicaid cuts that President Bush is already hinting he will ask for in his 2006 budget. In addition, he will face numerous issues concerning the new Medicare prescription drug program as well as Food and Drug Administration concerns over the approval and regulation of prescription drugs. [bm]
New Managed Care Article
Professor Nan Hunter of Brooklyn Law School has posted a drafat of an article concerning the due process issues surrounding the new managed care adjudication. I did not realize how popular this private adjudication had become. It is a very enlightening article and an intelligent and interesting read. The abstract is below.
This article examines how legal, political and economic change has produced a new adjudicatory mechanism for resolving disputes between patients and managed care organizations. In 43 states, external review laws allow patients whose claims for care or reimbursement have been denied by MCOs to "appeal" through a system that uses private judging companies to review the MCO decisions. Most of the claims concern whether a particular treatment is medically necessary, and the external review companies employ a mix of legal and health professionals to make those judgments. In essence, regulation of this critically important aspect of MCOs has been outsourced to a small but growing industry niche, which provides "due process lite" for patients.
The article begins by describing how a substantive standard of deference to medical authority in tort law leaked into and defined process aspects of health law as well. Then, because of the transformation to managed care models for service delivery, the old deference model fell victim to economic constraints. External review laws were enacted as part of the backlash against the abruptness of that transformation. They emerged from political coalitions searching for a new mechanism of accountability for the private sector.
Second, the article revisits procedural due process theory, which was a vibrant field of scholarship 25 years ago, but which today is virtually moribund. I describe how external review laws illustrate the use of dispute resolution procedures to achieve accountability and the emergence of accountability as a primary process value. I also argue that a second process value reflected in the new external review systems - deliberativeness - may be of equal or greater significance than the right to a hearing, the traditional flash point for debates about process.
Third, I articulate both the link between procedure and regulation, and also the connection between regulation by procedure to theories of governance. Specifically I argue that we can understand the use of adjudicatory process as one technique of governing at a distance, a method through which preferred policies and norms can be advanced indirectly, by non-governmental as well as governmental actors, rather than by direct, command-and-control state policies. [bm]
You can find the draft article here.
January 26, 2005
Slandering Your Doctor
In a novel case testing First Amendment rights,two dental practicioners have filed suit in a Florida trial court to stop a disgruntled former patient from criticizing their care on her web site, dentalfraudinflorida.com.
On the site, Ms. Prentice complains in detail about what in her opinion was the terrible care she received from Dr. Leonard Tolley and Dr. Richard Kaplan and describes her ordeal as a personal tragedy. In response, the dentists argue the site is slanderous, a "public nuisance" and violates state law requiring that state disciplinary complaints be kept confidential if they are dismissed. Prentice and her lawyer claim that her opinions are protected by the First Amendment.
Disgruntled patients, however, are not the only ones using the internet to disseminate information. Various medical groups and doctors have created sites posting the names of patients who are viewed as litigation risks. For further information, please click here. [bm]
Sarbanes Oxley and Non-profits
As those of you who serve on non-profit boards may already be well aware, many such boards have been considering adopting various portions of the Sarbanes-Oxley Act. Enacted in 2002, the Sarbanes-Oxley Act, the corporate governance reform law passed in the wake of the Enron Corp. and WorldCom Inc. scandals is aimed primarily at pubic companies. However, recent scandals in the non-profit world have shaken that community and caused a general review of their corporate practices. According to a recent study by the accounting firm Grant Thornton LLP reported that 48 percent of the nation's nonprofits have made voluntary changes to their governance practices since the passage of Sarbanes-Oxley. This includes rewriting corporate charters, redrafting conflict-of-interest policies, and, in some instances, performing costly examinations of their internal controls.
All indications are that more regulation of non-profits will occur soon. Federal and state regulators have indicated a greater willingness to regulate non-profits. In November, California enacted the first governance law for nonprofits, which, among other things, requires charities doing business in the state with revenues above $2 million, to form audit and compensation committees. And last summer, the IRS announced that it was launching an investigation into nearly 2,000 nonprofits. In addition, Charles Grassley ( R-Iowa), chairman of the Senate Finance Committee, announced that his committee is working on a bill that would impose several governance reforms on nonprofits; the legislation is expected to come up for a full committee vote early this year.
For further information, please see this article. [bm]
Euthanasia Notes From All Over
- Today's Houston Chronicle has an article about a futility dispute between the attendings at Texas Children's Hospital and the mother of a 4-month-old who has been diagnosed with "thanatophoric dysplasia, a condition characterized by a narrow chest, small ribs, underdeveloped lungs and disproportionately short arms and legs . . . Thanatophoric dysplasia belongs to a family of genetic disorders that includes dwarfism, but this particular form is almost always lethal, said Ericka Peasley, a genetic counselor who serves on the medical advisory board of Little People of America, an advocacy group. . . . Infants with the condition usually are stillborn or die shortly after birth from respiratory failure." According to the story, "Texas Children's officials said the baby is not conscious and doesn't move" and is on ventilator support.
Neonatologists and bioethicists who have reviewed the case agreed with the physicians in the case that "it would be unethical to continue with care that is futile and prolongs [the patient's] suffering." Under state law, disputed life-sustaining treatment may with withdrawn over the objections of the surrogate decision maker, if the hospital's ethics committee agrees with the attending physician that the treatment is inappropriate. It is not clear from the article whether the ethics committee process was actually invoked. Instead, the hospital has elected not to rely on the "due process safe harbor" provided by the Texas Health & Safety Code, chapter 166, and has gone to court to obtain an order. The hospital is even paying for legal fees of the mother's attorney. A court hearing has been scheduled for February 9.
- The January 20 Washington Times reported that the Archbishop of Canterbury, Dr. Rowan Williams, wrote an op-ed in the Times of London reiterating the opposition of the more than 70-million-member Anglican Communion to euthanasia. Apparently the piece was prompted by the comments of "Robin Gill, a Canterbury University professor who advises Williams, [who] said publicly people should not be prosecuted for helping dying relatives in pain end their lives."
I always get nervous about blanket denunciations of "euthanasia" without a careful delineation of what is and is not being condemned, but Dr. Williams was careful to make clear that the target of his remarks was PAS and "active euthanasia":
Euthanasia is best defined as the initiating of a process whose explicit primary aim is to end life. It is not the same as continuing a medical process whose long-term effect may be to reduce the span of life, nor is it the same as embarking on a treatment that offers short-term relief at the cost of possibly accelerating overall decline. These are the commonplaces of palliative medicine. The right to be spared avoidable pain is beyond debate - as is the right to say yes or no to certain treatments in the knowledge of factors such as these. But once that has mutated into a right to expect assistance in dying, the responsibility of others is involved, as is the whole question of what society is saying about life and its possible meanings. Legislation ignores these issues to its cost.
The full text of his op-ed article can be found on the Archbishop's web site.
- The BBC reported last Sunday that an article in the Dutch Journal of Medicine reports that
Dutch doctors have reported 22 mercy killings of terminally ill babies since 1997. . . . None of the doctors involved were charged, although euthanasia for children is illegal in the Netherlands. . . .
The cases involved babies with extreme spina bifida, a disabling birth defect.
The study showed that prosecutors had decided not to file charges as long as four unofficial rules were met:
- the child's medical team and independent doctors must agree
- there is no prospect of improvement and the pain cannot be eased
- parents give their consent
- the life must be ended in the correct medical way
A survey has suggested Dutch doctors end the lives of about 15 to 20 disabled newborns a year but most go unreported.
January 25, 2005
Charity Governance and Oversight
Panel on Nonprofit Sector Releases Draft Recommendations for Improving Charity Governance and Oversight
The Panel on the Nonprofit Sector has released draft Recommendations for Improving Charity Governance and Oversight made by five Work Groups and an Expert Advisory Group The Recommendations fall into four broad categories:
- Improving Transparency and Financial Management
- Improving Government Oversight and Enforcement
- Improving Governance and Self-Regulation
- Compliance Requirements for Small Organizations
The Panel comprises 24 leaders convened by Independent Sector at the encouragement of the U.S. Senate Finance Committee. To give comments on the draft, see here. To participate in a free national conference call about the draft to be held tomorrow (Wed., Jan. 26) at 2:00 - 3:30 p.m. EST, see here.
Ethics of Patient Advertisement
I don't know what the ethics are concerning physician advertisements that use past successes with patients to attract new patients but I assume that Senator Coleman's office must know. His cosmetic dentist, Dr. Milnar has run an ad on his website that shows Senator Coleman's teeth in a before and after format.
Rawstory has a further article discussing the Senator's new smile and the dentist. According to that website, there may have been some mistakes made in the use of the Senator's photo for commercial purposes as well as some other issues involving the Senator's payment for the dentistry.
Quite frankly, I may be a bit biased but I think that my son has the after picture beat.[bm]
Care Coordination and Liability Concerns
Professor Mark Hall has a new article in the Annals of Family Medicine entitled, "Liability Implications of Physician-Directed Care Coordination." It provides an interesting overview of the current liability situation for those physicians involved in care coordination with statistical data obtained from recent interviews as support for his conclusion that care coordination may lead to lower liability risk. ABSTRACT: Various public and private initiatives encourage physicians to coordinate care for patients with multiple chronic conditions, but physicians may resist doing so for fear of liability. This article assesses the extent of liability risk using qualitative methods that combine legal research with key informant interviews. Some aspects of care coordination for patients with multiple chronic conditions hold potential for higher liability. Physicians coordinating care have a broader responsibility for patients with complex conditions who have a greater chance of poor outcomes. Care coordinators may be held to a higher standard of care by adopting best practices guidelines or by making medical decisions on issues that require specialized expertise. However, other aspects lower liability risk: elderly patients are less likely to sue; care coordination should improve outcomes; and the information systems that support enhanced care coordination target the major sources of medical error in primary care. On balance, the liability risks of care coordination are commensurate with other risks in primary care practice. Liability insurers indicated no reluctance to insure physicians who coordinate care for patients with multiple chronic conditions, and no strong tendency to attribute higher risk to this role. Physicians who currently perform these or similar functions have not encountered demonstrably higher liability. On balance, there is no strong basis for physicians who perform care coordination functions to have serious concerns about liability; instead, care coordination done well may lower liability risks.
Professor Mark Hall has a new article in the Annals of Family Medicine entitled, "Liability Implications of Physician-Directed Care Coordination." It provides an interesting overview of the current liability situation for those physicians involved in care coordination with statistical data obtained from recent interviews as support for his conclusion that care coordination may lead to lower liability risk.
Various public and private initiatives encourage physicians to coordinate care for patients with multiple chronic conditions, but physicians may resist doing so for fear of liability. This article assesses the extent of liability risk using qualitative methods that combine legal research with key informant interviews. Some aspects of care coordination for patients with multiple chronic conditions hold potential for higher liability.
Physicians coordinating care have a broader responsibility for patients with complex conditions who have a greater chance of poor outcomes. Care coordinators may be held to a higher standard of care by adopting best practices guidelines or by making medical decisions on issues that require specialized expertise. However, other aspects lower liability risk: elderly patients are less likely to sue; care coordination should improve outcomes; and the information systems that support enhanced care coordination target the major sources of medical error in primary care. On balance, the liability risks of care coordination are commensurate with other risks in primary care practice. Liability insurers indicated no reluctance to insure physicians who coordinate care for patients with multiple chronic conditions, and no strong tendency to attribute higher risk to this role. Physicians who currently perform these or similar functions have not encountered demonstrably higher liability. On balance, there is no strong basis for physicians who perform care coordination functions to have serious concerns about liability; instead, care coordination done well may lower liability risks.
Viagra May Shrink Heart
A news article reports that doctors have discovered that viagra not only helps with erectile disfunction but also provides help to those with enlarged hearts.
"Researchers at Johns Hopkins University School of Medicine in Baltimore, Maryland have found that sildenafil citrate—Viagra—treats enlarged hearts in mice, stopping further muscle growth, reversing existing growth and treating cellular and functional damage.
"A larger-than-normal heart is a serious medical condition, known as hypertrophy, and is a common feature of heart failure that can be fatal," says study senior author and cardiologist David Kass"
Amazing how one drug can shrink certain parts and ... well ... you know the rest. Thanks to mrsun.us for the article update. [bm]
State Prompt Pay Claims Not Pre-empted by ERISA
From Mealey & Lexis:
NEW YORK — Because a hospital’s state law claim seeking to recover payment at an undiscounted rate after a patient’s preferred provider failed to pay the discounted amount on time does not seek to redress violations of rules that the Employee Retirement Income Security Act’s civil enforcement provisions are designed to remedy, remand to state court is proper, a New York federal judge held on Jan. 6 (NYU Hospitals Center-Tisch v. Local 348 Health and Welfare Fund, No. 04 Civ. 6937, S.D. N.Y.; 2005 U.S. Dist. LEXIS 256 (requires paid subscription)). [tm]
State Medical Association Lacks Standing to Sue MCO Over Payments to Docs
From Mealey & Lexis: Continuing a trend (it appears) of state medical associations who challenge MCO payment practices being poured out on standing grounds: HARTFORD, Conn. — The Connecticut Supreme Court on Jan. 11 in separate opinions affirmed the dismissal of suits brought against two managed care companies for allegedly unfair and deceptive practices related to payments made to physicians, finding that the medical society that brought the claims lacked standing to sue because their alleged harms were indirect and its physician members could bring the claims themselves (Connecticut State Medical Society v. Oxford Health Plans, No. SC17071; Conn. Sup.; 2005 Conn. LEXIS 2; Connecticut State Medical Society v. ConnectiCare Inc., No. SC 17072, Conn. Sup.; 2005 Conn. LEXIS 4). [tm]
January 24, 2005
SCOTUS Denies Review of Fla. Sup. Court's Decision on Terri's Law
The Supreme Court of the United States released its most recent cert. list this morning and denied Jeb Bush's cert. petition in the litigation over the constitutionality of Terri's Law (U.S., No. 04-757). [tm]
HHS OIG's Report on GPO Rebates and Members' Cost Reports
Department of Health and Human Services, Office of Inspector General -- AUDIT
"Review of Revenue From Vendors at Three Group Purchasing Organizations and Their Members," (A-05-03-00074 (PDF)) -- January 19, 2005
The objectives of this review were to determine (1) how much revenue three large GPOs received from vendors and what the disposition of that revenue was, (2) how members treated distributions of net administrative fee revenue received from GPOs on their Medicare cost reports, and (3) whether members properly recorded rebates received from vendors on their Medicare cost reports. We found that the three GPOs we reviewed collected $1.3 billion representing net revenue in excess of operating costs. The GPOs retained $415 million of the $1.3 billion in net revenue to provide reserves and venture capital for new business lines. They distributed the remaining $898 million to members. We also found that the GPO members we reviewed did not fully account for the net revenue distributions on their Medicare cost reports. GPO members generally offset rebates on their Medicare cost reports as required. We recommended that CMS (1) provide specific guidance on the proper Medicare cost report treatment of net revenue distributions received from GPOs, and (2) prepare a “frequently asked questions” or other bulletin to remind institutional providers that all rebates from vendors must be shown as credits on their Medicare cost reports.
Health Care According to Frist
The New England Journal of Medicine has an article written by Dr. William Frist, you may know him better as Senate Majority leader Frist. Since everyone wants to know what the 109th Congress may do with regard to health care, the article may provide some insight. I was rather surprised that Senator Frist seems to be a supporter of a mild form of universal health care. Indeed there was much for me to agree with in his piece. [bm]
Thoughts on the Vioxx Litigation
In this week's New Yorker, James Surowiecki has a short article on the issues surrounding the tort system and its role in determining which drugs are on the market. He uses the Merck/Vioxx upcoming litigation to express his concerns about the tort system. He states,
"Questions about Vioxx’s potential risks have been common since its introduction, six years ago, especially after a 2000 trial suggested that the drug increased the risk of heart disease. Merck did not hide these data, and beginning in 2002 the drug’s label included a warning about the possible cardiovascular risks. Some critics, however, have suggested that the company soft-pedalled the dangers. Internal company documents show that Merck employees were debating the safety of the drug for years before the recall.
From a scientific perspective, this is hardly damning. The internal debates about the drug’s safety were just that—debates, with different scientists arguing for and against the drug. The simple fact that Vioxx might have risks wasn’t reason to recall it, since the drug also had an important benefit: it was less likely to cause the internal bleeding that aspirin and ibuprofen cause, and that kills thousands of people a year. And there’s no clear evidence that Merck kept selling Vioxx after it decided that the drug’s dangers outweighed its benefits. . . .
Obviously, there’s something wrong with a system that discourages the careful weighing of costs against benefits—we want companies to learn as much as they can about the downsides of their products. But companies like Merck, which spend hundreds of millions on ads targeting consumers, have themselves to blame, too. Instead of getting people to think about drugs in terms of costs and benefits, these ads encourage people to think of medicine in the same way they think of other consumer goods. It would be one thing if Merck had marketed Vioxx only to people who really needed it—people who couldn’t take ibuprofen or aspirin safely. Instead, the company marketed it aggressively to everyone, so that some twenty million Americans had Vioxx prescriptions. That’s why the potential damages against Merck are so vast. If juries have a hard time accepting a risk-benefit trade-off when it comes to drugs, it’s in part because the drug companies have convinced them that no such trade-off has to be made."
The entire article makes for an interesting read. As our nation considers tort reform, the question becomes should we cap damages or should we engage with manufacturers and the public to educate them about the trade-offs and the science behind certain pharmaceutical products. In addition, the FDA may want to strenghen some aspects of its review of these products and their ads. [bm]
January 23, 2005
Cuts in Medicaid Predicted
For those you following the budget deficit and President Bush's promise to cut that deficit in half - it looks like some of that savings will come from cuts in the Medicaid program. According to a variety of anonymous jWashington D.C. sources, some of the President's proposals include providing states more flexibility to use federal Medicaid funds, but also to reduce doctor's reiumbursements, trim fraud, and to limit the program's growth on a per-patient basis.
Medicare Drug Benefit Final Rules Issued
HHS announced that it posted the final rule implementing the Medicare pharmaceutical benefit in last Friday's Federal Register. HHS' press release is here: http://www.hhs.gov/news/press/2005pres/20050121.html/. (Nothwithstanding, the rinal rule is not in Friday's Federal Register, but when it does appear we'll post the cite.) [tm]