As I wrote previously – see here, here, here, here, here, here, here, here, and here – whether a tort action sounds in “medical malpractice” as opposed to general negligence, or vice versa, can be crucial. Suits sounding in “medical malpractice” must satisfy special requirements that include shortened limitations periods, statutes of repose, and expert affidavits (or certificates of merit) at filing. In many states, those suits are also subject to special damage caps. Suits sounding in general negligence are free from these constraints. Filing and prosecuting those suits is consequently not as onerous and expensive as filing and prosecuting medical malpractice actions. For that reason, we witness many disputes over this pivotal categorization issue. Continue reading →
A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:
Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.
Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.
Scott County, Indiana, which only has a few thousand residents, has historically had an average of five HIV cases per year. Since December 2014, however, the county has seen an outbreak, with more than 140 newly diagnosed cases. Dr. Jonathan Mermin, the director of the National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention at the Center for Disease Control (CDC) calls this “one of the worst documented outbreaks of HIV among IV users in the past two decades.” Dr. Joan Duwve, the chief medical consultant with the Indiana State Department of Health, explained that the abuse of the prescription drug Opana was one of the catalysts for the increase in HIV cases, with some residents injecting it as frequently as 10 times a day, and sharing syringes with other members of their community.
HIV is mainly spread either by sexual contact with another person with HIV, or by sharing needles or syringes with someone who has HIV. One way to reduce the spread of the disease is to implement syringe exchange programs (SEPs) that reduce the transmission of blood-borne pathogens like HIV by providing free sterile syringes and collecting used syringes from injection-drug users (IDUs).
The Affordable Care Act is sprawling. Some of its myriad provisions may (or may not!) reduce healthcare costs. Think of accountable care organizations, the hospital readmission reduction program, or even the preventive services mandate. And so, the Act’s success is often evaluated by asking whether it has helped reduce healthcare costs. (See, e.g., David Cutler here.)
Other of the ACA’s provisions are intended to promote financial security in the face of illness. The Act’s most litigated provisions, requiring that people buy insurance, expanding Medicaid, and creating exchanges, can be understood primarily in this light. And so, the Act’s success is also often evaluated by asking whether it has truly promoted financial security. (See today’s New York Times piece from Margoret Sangor-Katz on the subject of underinsurance post-ACA, or Aaron E. Carroll’s take from December.)
A third way of understanding the ACA’s reforms–and evaluating its success or failure–too often gets left out (as it was by the NY Times here): The ACA can perhaps most coherently be thought of as an equal protection statute.
Earlier this spring, the U.S. Department of Health and Human Services and Department of Justice reported they had recovered nearly $28 billion as a result of anti-health care fraud efforts in FY 2014. The federal False Claims Act played a substantial role in achieving these recoveries: the government recovered $2.3 billion in FCA settlements and judgments, and opened nearly 800 new civil health fraud investigations, in FY 2014 alone. Further, the agencies noted that these anti-fraud efforts—bolstered by increased funding and authority under the Affordable Care Act—are continuing to abandon the “pay and chase” method of fraud enforcement, relying instead on prevention and “real-time data analysis.”
June 30, 2015, 8:00 AM – 5:00 PM Wasserstein Hall, Milstein West A
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]
Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain? Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.
The full agenda will be announced in the coming weeks. Check backhere for news!
This event is free and open to the public, but seating is limited and registration is required. Register now!
The supply of donor organs is in constant peril. But researchers around the world are working to develop spare human parts out of both machines and animals. Professor Lesley Sharp’s new book, The Transplant Imaginary, is a vivid look at how experts in “highly experimental sciences” navigate the moral world of their work—and how they think about its implications. Along with students in my course, “Healing Animals,” I recently spoke with Sharp about her new book.
The Transplant Imaginary is essential reading for anyone interested in law, ethics, and medical research. Sharp takes a look at things people cannot see and yet which factor crucially in scientific work. She recognizes that science is morally laden work, and her book helps to explain choices in a world of limited resources—and asks whether these are the only choices we have. Continue reading →
Earlier today, the House Energy and Commerce Committee released the most recent draft of the 21st Century Cures Act, in time for it to be marked up by the Health Subcommittee tomorrow. At 300 pages, the new draft adds back in a number of provisions that were excised from the previous, 200-page iteration of the draft. I haven’t had time to uncover all of the new additions just yet, but given that this is my third blog post on the subject, I wanted to highlight some of the ways in which this version differs (and doesn’t differ) from the last draft.
Wellness programs have been enthusiastically embraced by employers seeking to promote health and hoping to control costs. On April 20, 2015, program proponents received long awaited news: the Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying how the Americans with Disabilities Act (ADA) would apply to wellness programs. Many large employers likely breathed a sigh of relief upon reading the rule, but the rule is not final and may reignite a longstanding debate over the appropriate use of wellness incentives.
Wellness programs have become common in the workplace. A 2014 Kaiser Family Foundation survey found that among large employers offering health benefits, just over half offered an opportunity to complete a health risk assessment (HRA), a questionnaire that is often a gateway for the provision of health risk information and other wellness program components (Exhibit 12.8 in the Kaiser survey). A similar fraction offered biometric screenings (Exhibit 12.1), such as tests for cholesterol or blood pressure, or measurement of body mass index. Some screening programs test for cotinine, which is associated with nicotine exposure.
Some wellness programs offer financial incentives such as premium adjustments or gift cards. The 2014 survey found that more than half of large employers using HRAs provide incentives for their completion, and more than a third of these incentives equaled or exceeded $500 (Exhibit 12.10). A federally commissioned report prepared by RAND suggests that incentives are effective in increasing HRA completion. […]
Amid this week’s disheartening studies highlighting discrimination of LGBT populations, the American College of Physicians (ACP) affirms its support and offers new recommendations for furthering LGBT health.
The bad “news”: is not really news. It is further evidence of how much more effort needs to be placed on ending LGBT discrimination and inequalities. A national survey published in the Ann of Intern Med found that lesbians were significantly less likely to get vaccinated for HPV than their heterosexual counterparts (adjusted prevalence of 8.5% v 28.4%). HPV is easily transmissible through contact and believed to be equally transmissible in gay and heterosexual women. The vaccine can prevent most cases of cervical cancer, which has terrible outcomes if discovered late, indicating that many deaths could have been prevented. An editorial in the same issue describes neglected health concerns affecting LGBT populations and calls for better professional education on LGBT health. The CDC’s and American Congress of Obstetrics and Gynecology’s (ACOG) efforts to inform patients about pap smear rates not been slow and inconsistent in changing medical practice. Combined with markedly lower HPV vaccination rates, cervical cancer remains a big concern. Continue reading →
A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:
In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.
More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.
However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]
Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated. Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience.
This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.
Keynote Lecture:Religious Liberty, Health Care, and the Culture Wars
Some of the behavioral changes that the Affordable Care Act seeks to bring about are prompted directly by the Act or a federal agency acting pursuant to the Act. The “individual mandate” that people buy health insurance is one example; individuals who do not change their behavior to comply with that particular provision of the law are subject to a tax penalty imposed by the IRS.
But much of the work of the ACA is done through regulatory intermediaries that are themselves incentivized by the Act to find ways to bring about the end-user behavioral changes that the ACA is really after. Medicaid expansion is a straightforward example–under the ACA the federal government does not provide insurance coverage to those who make less than 133% of the federal poverty line, rather, it incentivizes states to do so. Accountable Care Organizations are another somewhat more roundabout example: the Act incentivizes doctors to form organizations that will themselves incentivize doctors to coordinate care and patients to obtain more value-maximizing services.
Like any principal-agent relationship, regulating through an intermediary has benefits and costs. The intermediary (state, employer, insurer, doctor, etc.) may be differently positioned than the federal government to obtain information about, and influence the behavior of, the actors whose collective behavior we ultimately care about, for better or worse. And certain intermediaries may be differently responsive to the concerns of those impacted by the policies they enact than the federal government, again for better or worse. Continue reading →
As prelude to the2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,”please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.
J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
How bad is the obesity epidemic among kids in America?
Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.
And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”
The freedom to develop cardiovascular disease?
School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]
This week we are joined by Bill of Health’s own Glenn Cohen, HLS Professor of Law and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. We discuss surrogacy arbitrage, MRT, CASPR DNA editing and “Uber” elder care.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.