The majority of people in La Crosse, Wisconsin have advance directives. The initiative to increase the utilization of advance care planning began as a way of helping patients, but resulted in large decreases in health care expenditures.
Due to Texas’ recently passed regulations on abortion clinics, two clinics closed this week. Abortion clinics in Texas are required to have a physician with admitting privileges at a hospital within 30 miles of the clinic under the new regulations.
A new law passed recently in Arizona would limit access to medication used for medical abortions. Planned Parenthood of Arizona filed a lawsuit this Wednesday to contest the law.
An HIV-positive baby treated with aggressive drugs immediately after birth was reportedly cured of the disease. This is the second such case of this treatment working, and is a promising development for the future of HIV treatment.
On Wednesday it was announced that Americans will be allowed to keep insurance plans that are not compliant with the Affordable Care Act. These plans will continue to be offered for the next two years.
Two surveys have found that uninsured Americans largely have not signed up for insurance following the implementation of the Affordable Care Act. Some suggest that the changes to the new healthcare law that have occurred since its adoption may be responsible for these low rates of enrollment.
In Washington state, people who operate medical marijuana dispensaries are worried about the effects of the state’s recent legalization of recreational marijuana. They worry that the increased demand for marijuana will put smaller dispensaries out of business.
Twenty-six states have introduced mandatory programs that emphasize private long-term care over nursing homes. Many states have modeled their plans after Tennessee, but long-term care in this state is suboptimal for many residents.
In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.
The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.
The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading →
1) Belgium’s recent vote to legalize euthanasia for children has drawn international debate and criticism. The law would allow terminally ill children to end their lives, provided that they have parental consent.
2) Lawmakers in California have proposed adding a warning label on soda and juice that has sugar added and over 75 calories per 12 ounces. The labels would warn against the health risks associated with consuming sugary beverages.
3) The Food and Drug Administration announced today that it will hold a meeting on the topic of changing the over-the-counter monograph system. Currently, the processes of publishing and changing a monograph are very time consuming.
4) Monsanto is producing new strains of vegetables without using GMOs. Instead, they are selectively crossbreeding different varieties of plants.
5) A recent study conducted by a group at Stanford University released findings that seriously injured patients with insurance are less likely to be transferred to trauma centers than uninsured patients. The group hypothesized that this difference in trauma care can be explained by the fact that non-trauma center hospitals have a financial incentive to keep insured patients under their care.
6) The sale and use of electronic cigarettes will be regulated in Beverly Hills, as decided by the Beverly Hills City Council earlier this week. Los Angeles passed similar legislation this December.
7) Enrollment in health insurance plans for one fifth of people who have registered under the Affordable Care Act was not completed, due to their failure to pay the first premium. Some insurers have granted more time for subscribers to pay their premiums.
8) Wendy Davis recently said that she would support restricting abortion access to the first twenty weeks of pregnancy, but filibustered last year against a bill containing that provision because of the wording of the bill and the other restrictions included within it.
1) On February 11, the FDA will launch its “Real Cost,” anti-smoking campaign. The $115-million campaign is geared toward discouraging teenagers from smoking by emphasizing the “personally relevant” effects of smoking.
2) Lawsuits against the manufacturer of Pradaxa, Boehringer Ingelheim, have revealed internal documents about the dangers of the drug. The drug, a blood thinner, has been associated with over 1,000 deaths.
3) By October 2014, CVS will no longer sell tobacco products. CVS has decided to implement this ban because, increasingly they see their role as providing health care, and tobacco products cause negative health effects.
4) Naxolone, a drug that is used to reverse the effects of opiate overdoses, is now available to patients in California through their doctors. Prior to the creation of this law, the drug was much less widely available–primarily it was administered in emergency rooms.
5) Following the implementation of the Affordable Care Act, between 1 to 2 million Americans have enrolled in Medicaid. A study from Avalere Health states that this number increased only partially because of the ACA.
6) This Thursday, the Food and Drug Administration released regulations to guarantee that infant formula is safe for consumption. The regulations stipulate that certain nutrients are included in the product, and require tests for pathogens.
According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:
On Monday, October 22, at the urging of Governor Kasich, the Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5 billion in federal funding to expand Medicaid in the State of Ohio. Under the laws of Ohio this action was valid.
The Controlling Board is a state agency created by statute. The agency has two principal powers: it can transfer funds and authorize purchases by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code states: “Controlling board authorization for a state agency to make an expenditure of federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”
Two advocacy organizations (the Buckeye Institute and the 1851 Center for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the Controlling Board. They contend that the action of the Board violates Section 127.17 of the Ohio Revised Code, which provides that the Board is bound by the intent of the Ohio General Assembly. The challengers quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich vetoed this bill, but the challengers argue that despite the Governor’s veto it’s clear that the General Assembly did not want the Controlling Board to accept federal funding to expand Medicaid.
“Examining the intersection of law and health care, biotech & bioethics”
- the subtitle of the Bill of Health blog.
I approach this intersection like many of my fellow students: outfitted with the tools and spectacles of a specific discipline. Whether that is health law, policy, medicine, engineering, philosophy, genetics, or cognitive science, none of us have had the ideal education that would enable not only an approach, but an inhabitation of this intersection.
What would that ideal education be? To consider the ideal education for a citizen, Rousseau conducts an elaborate thought experiment giving that education to a fictional young boy named Emile (hence the title of the work: Emile, or On Education). Let us begin a similar experiment to consider the ideal education for someone to inhabit the intersection of law and health care, biotech & bioethics.
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell  came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.
Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells. ASCs are found throughout the body. Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells. It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad.
A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices. Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells? In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.
In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].
This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]
It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.
We may be living in a golden age of group-think. A weekly reminder is poor Paul Krugman railing against the apparently universal belief in America and Europe that we’ve got to cut budgets right now or disaster will strike. He calls this a Zombie idea, a false claim that has been falsified with plenty of stakes in the heart, silver bullets and blows to the head, but will not stay in the grave.
Closer to home for us in public health is the claim that Americans don’t like government rules regulating their behavior and meddling with their preferences. Cass Sunstein and Richard Thaler have delivered some solid blows to the idea that paternalism typically messes with solid preferences. As we celebrate Public Health Week, I want to highlight two recent papers that show that Americans, like the children in Mary Poppins, actually like their nannies, who do some pretty great things.
Public Health Law Research has recently posted the manuscript of a paper that Evan Anderson and I have prepared for the Annual Review of Law and Social Science. The paper describes the dramatic rise of law as a tool of public health since the 1960s in five major domains: traffic safety, gun violence, tobacco use, reproductive health and obesity. These topical stories illustrate both law’s effectiveness and limitations as a public health tool. They also establish its popularity by the most apt of metrics – the willingness of legislators to enact it. The one picture worth a thousand words, below, depicts the rapid adoption of a variety of interventions by state legislatures. (By the way, the five examples also show that public health law research can and does influence the development and refinement of legal interventions over time.)
Typically, we would avoid such a shameless plug for our researchers — we’d be a little more subtle. But, we can’t help it this time. This book is the best $10 you’ll spend all year.
A little less than a month ago, Johns Hopkins University convened more than 20 of the world’s leading experts on gun violence and policy to summarize their research and recommend policy changes. This 282-page book features empirical research from the leading experts in the field covering the topics of mental health and gun violence, gun law enforcement, high-risk guns, international case studies of responses to gun violence, the Second Amendment, public opinion on gun policy, and concludes with a summary of the recommendations for reforms to Federal policies.
Chapter 3, “Preventing Gun Violence Involving People with Serious Mental Illness,” features research conducted by Jeffrey Swanson, PhD, and his team of researchers based at Duke University. The research presented was funded by PHLR and the National Science Foundation.
This past week, PHLR hosted 150 researchers, lawyers, public health practitioners and others for our fourth annual meeting. With our theme for the conference in mind, “Driving Legal Innovation,” our attendees shared results of evaluations of laws and regulations, offered up suggestions for new ways to use law to improve health, and attacked head on the issues facing the United States and our public health.
While you wait for more multimedia content, here are a few highlight moments: Continue reading →
This past September, I had the unfortunate and ironic experience of transitioning from conducting research on the American healthcare system to being a patient in the American healthcare system. In September, I was diagnosed with testicular cancer, while working as a research assistant for Professor Einer Elhauge, scouring the Affordable Care Act for regulatory powers with potential for defragmenting our national healthcare system.
Professor Elhauge, recently described fragmentation as a systemic lack of coordination between physicians, as well as between physicians and hospitals. This fragmentation results in increased medical cost and medical errors. My experience as a patient has led me to believe that defragmentation could help reduce other, less quantifiable, emotional and psychological costs to patients. I will attempt to demonstrate this through recounting the first half of my story.
As the New York Times reports (quoting me on the ethics), some American IVF clinics are now running raffles where the prize is IVF services. The contests give clinics publicity and sometimes serve charitable causes. Are IVF raffles unethical? Should we ban them?
Gambles and contests over the ability to have babies represent a new level of commodification—if you will, a new frontier. But they are not always unethical. Clinics do not owe infertile couples free access to IVF services. In some cases, the state and insurers don’t owe it to them either—legally or morally. IVF is expensive and some medical services are needed even more badly. Uninterested couples can avoid these raffles. What these raffles do is to give infertile couples opportunities that they would lack otherwise for obtaining an important benefit, opportunities that go beyond what clinics owe them. Lotteries, in particular, are not necessarily unfair means of distributing resources. Some philosophers deem them very fair. Even when couples with means can buy several raffle tickets, impoverished couples still get better chance of IVF access than under the current system. Money speaks, but it speaks less vocally than in much of American healthcare. In this respect, these raffles are a good parody of our unjust system.
These contests are games. Conservatives worry that they take infertility or the beginnings of human life too lightly. But light-heartedness could be a good thing in this area. It might reduce the anxiety and the stigma that too often accompany infertility treatment. Associating the conception of new human life with fun? Traditional procreation can do that, too!
In short, not everything that’s odd is unethical. Notwithstanding initial “yuck” feelings, raffles for IVF access are not always morally wrong. It would have been morally more ideal if clinics offered free IVF services to everyone, or prioritized the neediest and the underserved, or gave rich and poor equal chance. But acting less than ideally is not doing wrong. Continue reading →
And today, Oklahoma’s September challenge to the ACA is making headlines. As I have described before, one of the new theories by which Jonathan Adler and the Cato Institute are seeking to thwart the ACA is by challenging the IRS rule that permits tax subsidies in exchanges created by the federal government, which Cato claims is not supported by the text of the ACA. (State exchanges are supposedly the only avenue for obtaining tax subsidies for private insurance purchases.) Oklahoma has brought this challenge to life in federal district court, and Cato’s interest in this and other challenges was apparently reiterated by Professor Adler during a Cato-organized panel on Wednesday. Continue reading →
The National Football League has given the National Institutes of Health $30 million for research on traumatic brain injury. There is much we don’t know about the causes, effects, prevention and treatment of sports-related brain injury – but that doesn’t mean that we should put all our eggs into the basket of biomedical research. Since Washington state pioneered its youth-sports brain injury prevention model-law in 2009, 40 states have passed laws setting out rules aimed at the problem (We’re tracking these on LawAtlas, the new PHLR policy surveillance portal). Most of these laws work by promoting identification of concussions, regulating the athlete’s return to play, and educating parents and coaches.
To put it another way, the nation, through a majority of its state legislatures, has embarked on a major initiative to reduce sports-related injuries. Tens of millions of people will be affected in some way – athletes, parents and coaches. Limited school-based resources will be consumed to comply with these laws. And, most importantly, people worried about the problem will, to some extent, rely on implementation of these laws to protect student athletes.
If this public health intervention were a drug or a new technique for changing behavior, its efficacy would be rigorously tested by government-funded research. Why should things be different because this possibly magic bullet happens to be based in the law? So far, the CDC has funded implementation case studies of youth sports concussion laws in Washington and Massachusetts. PHLR is funding a more in-depth study in Washington, with results expected next year.
I am back after a brief hiatus for the Jewish holidays. L’Shanah Tova to all my readers who have just celebrated the Jewish New Year.
The first Monday in October is, of course, a special day for all of us legal eagles–the Supreme Court is back in session. The other significant thing about October 1 for those interested in health law is that hospitals will now be fined if too many of their Medicare patients are readmitted within 30 days of discharge due to complications. As reported by the Associated Press, this is part of the Affordable Care Act’s push to incentivize quality improvement while trying to save taxpayers money. Right now, admissions for only three medical conditions are subject to the penalty: heart attacks, heart failure and pneumonia. Penalties are held to a maximum of 1% of the hospital’s Medicare payments for now, but will rise to a maximum of 3% of Medicare payments over several years. This attempt to control quality of care on the back-end constitutes a marked contrast with the way reimbursement policy has worked over the last several decades to discourage hospitals from keeping patients in beds for “social” reasons, such as having nobody to care for them at home if they are discharged. Many Medicare hospital readmissions are due to non-compliant behavior by fragile patients with few resources to help them once they leave the hospital, something that is not really subject to the hospital’s control, and says nothing about the hospital’s quality of care for the patient. For decades, Medicare payment policy, which generally pays hospitals the same amount for caring for a patient regardless of how long he or she is in the hospital, has encouraged speedy discharges. This is touted as a way to save costs. Apparently, the new policy on payments for readmission is an acknowledgement that there is both a financial and a human cost to treating medically and socially fragile people in the express lanes of health care. It remains to be seen whether the penalties result in better quality care, or significant savings, but surely they will result in increased work for hospital social workers and discharge planners. Continue reading →
During the debate over the Affordable Care Act, the Obama administration and other proponents of electronic health records (EHRs) cited a RAND study projecting cost-savings of $80 billion a year from EHRs. More recent data have cast doubt on those estimates. In March, for example, a study in Health Affairs found that physicians with access to electronic records were more likely to order MRI scans and other diagnostic tests. Last week, the New York Times reported that EHRs apparently lead hospitals and physicians to bill more aggressively for their services, using higher billing codes than justified by the services they provide. (For an earlier post on the disappointing impact of EHR, see here.)
It’s easy to see the value of including scientists in public health law research teams; most public health lawyers lack the training to conduct rigorous empirical research. It may be harder to see the need for adding lawyers to the research team, but their presence is no less critical. Sometimes scientists have as much trouble understanding the law as the lawyers have understanding the science.
The value of involving lawyers in public health law research became clear to me recently as I was working on a project relating to health policies affecting immigrants. One question I wanted to know was how the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) affected immigrants’ access to health insurance in the United States. So I decided to review the scientific literature. The results were dismaying.
The concept of “overcriminalization” is gaining traction across the political spectrum.
The Heritage Foundation, which has a website devoted to the phenomenon, defines it as “the trend in America – and particularly in Congress – to use the criminal law to ‘solve’ every problem, punish every mistake (instead of making proper use of civil penalties), and coerce Americans into conforming their behavior to satisfy social engineering objectives.” Others, like Michelle Alexander, drop the Ayn Rand tones and focus on mass incarceration as racialized social control. (My colleagues and I once calculated that African American males can expect to spend on average 3.09 years in prison or jail over their lifetime.) Douglas Husak argues that we need a theory of criminalization to help us get less of it.
One of the best examples of criminal law rushing in where angels fear to tread is the criminalization of HIV exposure. From the start, there was reason to fear that these laws would not reduce HIV transmission, and might exacerbate stigma and social hostility towards people with HIV. There was concern they might be used selectively, or just randomly.
Sometimes researchers can tell policy makers pretty confidently what public health law interventions really make a difference. The PHLR website has more than 50 Evidence Briefs that summarize the results of systematic reviews of the evidence on interventional public health laws conducted by the Cochrane and Campbell Collaboratives, and the Community Guide to Preventive Services.. We know, for example, that there is significant evidence to support water fluoridation as an effective public health intervention aimed at reducing tooth decay (Portland, are you listening?). We know that workplace smoking bans prevent heart attacks. For laws like these, we have numerous high quality studies, sometimes even experiments, that show whether or not the law is effective.
Unfortunately, problems don’t wait for evidence, and usually by the time there is a substantial body of evidence in place to review, most states have already made their policy decisions. What do we do when there is a problem that demands action, but there is no clearly effective legal action to take?
One of these days we’ll blog about what we think should happen. But for now, we can look at what often does happen. Usually, it resembles the fads we see in fashion: One state tries something, and other states follow, until a lot of states are doing something that might, or might not be working.