Bloomberg Visual Data has published an incredibly effective visual exploration of US mortality data, here.
- Diana Winters, Intractable Delay and the Need to Amend the Petition Provisions of the FDCA, SSRN/Ind L.J.
- Xiaoyan Huang and Meredith Rosenthal, Transforming Specialty Practice — The Patient-Centered Medical Neighborhood, N Engl J Med
- Ameet Sarpatwari, Jerry Avorn, and Aaron S. Kesselheim, Using a Drug-Safety Tool to Prevent Competition, N Engl J Med
- Adam Candeub, Digital Medicine, the FDA, and the First Amendment, SSRN/Ga. L.Rev.
Every year, in order to prevent a statutorily-triggered decrease in physician reimbursements under Medicare, Congress must adjust the statutorily-prescribed fee schedule. This is known as the “doc fix.” The American Medical Association, for what it is worth, has lobbied for a permanent doc fix, but that has not happened yet.
This year’s automatic pay cut was going to be 24%, and for a moment a temporary fix was in doubt because of bipartisan support for a permanent fix. But thanks to some procedural maneuvering yesterday, it looks like a temporary doc fix is through the house, at least. (See coverage in Politico here and Washington Post here. And just for fun, see a show about getting things through the house with procedural maneuvering here.)
In addition to the doc fix, a provision included in the House bill would forbid the Department of Health and Human Services from conducting post-payment review through Recovery Audit Contractors of inpatient hospital admission until March 31, 2015. This will stop for at least a year a review program that, in its last full year of operation, returned to the Medicare trust fund (and took away from hospitals) billions of dollars. (See commentary condemning the delay here and commentary criticizing the Recovery Audit Contractor program here.) It’s a notable development and if passed will kick the can down the road a short ways for Medicare to decide how it wants to handle utilization review in this area.
By Ching-Fu Lin
China’s highest executive organ, the State Council, put out the Food and Nutrition Development Outline 2014-2020 (the Outline) in February of 2014. The Outline was jointly drafted by China’s Ministry of Agriculture (MOA) and National Health and Family Planning Commission. The Ministry of Finance, Ministry of Education, Ministry of Commerce, Ministry of Science and Technology, and National Development and Reform Commission also participated in its development. Based on a review of China’s growth and problems in food and nutrition, the Outline sets a seven-year plan that highlights basic policy objectives. The areas of focus are food supply systems, nutrition intake and balance (especially amongst population sub-groups), regulatory and surveillance mechanisms, industry development, research, and education.
The Outline lays out its “guiding strategy” that the government should regard the effective supply of food, balanced nutritional profile, and production-consumption coordination as its chief missions. To execute these missions, the government identifies certain key products (quality agricultural products, convenient processed foods, and dairy and soy foods), key areas (poor, rural, and newly urbanized areas), and key population groups (the pregnant women and nursing mothers, infants and children, and the elderly) as starting points to promote better food and nutrition development patterns. Such points are further elaborated in the document. The guiding strategy ultimately aims to improve public health and a well-off society.
Details and registration are here.
March 28, IU Robert H. McKinney School of Law, Indianapolis. The Hall Center for Law and Health and the Indiana Health Law Review present a major conference on neuroscience and the law. Speakers include:
- Oliver R. Goodenough, Professor of Law, Vermont Law School
- Geoffrey K. Aguirre, Associate Professor of Neurology, Perelman School of Medicine, University of Pennsylvania
- Brenna C. McDonald, Assistant Professor of Radiology and Neurology, Stark Neurosciences Research Institute, Indiana University School of Medicine
- Matthew Mitten, Professor of Law and Director, National Sports Law Institute, Marquette University Law School
- Jean M. Eggen, Distinguished Professor of Law, Widener University School of Law
- Tracy D. Gunter, Associate Professor of Clinical Psychiatry, Indiana University School of Medicine
- Robert M. Pascuzzi, Professor and Chairman, Department of Neurology, Indiana University School of Medicine
- Leslie A. Hulvershorn, Assistant Professor of Psychiatry, Indiana University School of Medicine
- Amanda C. Pustilnik, Associate Professor of Law, University of Maryland Francis King Carey School of Law
- Jennifer A. Drobac, Professor of Law, Indiana University McKinney School of Law
- Andrew J. Saykin, Raymond C. Beeler Professor of Radiology and Director, Indiana University Center for Neuroimaging, Department of Radiology, Indiana University School of Medicine
- Rebecca S. Dresser, Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine, Washington University School of Law
- Eric Racine, Director, Neuroethics Research Unit, University of Montreal and McGill University
High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART eligibility including all – in the US guidelines – or nearly all – in the WHO guidelines – HIV-infected people. In this panel, we are bringing together the leaders of three TasP trials in sub-Saharan Africa, bioethicists, and public health researchers to debate the tension between the policy intentions expressed in these guidelines and the historic opportunity to learn whether TasP works or not. Please join us in considering different options to resolving this tension.
- Till Bärnighausen, Harvard School of Public Health, and Wellcome Trust Africa Centre for Health and Population Science
- Max Essex, Harvard School of Public Health
- Deenan Pillay, Wellcome Trust Africa Centre for Health and Population Science, and University College London
- Velephi Okello, Swaziland National AIDS Programme, Ministry of Health
- Dan Wikler, Harvard School of Public Health
- Nir Eyal, Harvard Medical School
Moderator: Megan Murray, Harvard School of Public Health and Harvard Medical School
Friday, March 7th, 10am-12pm
Kresge G3, Harvard School of Public Health
HEA’s first talk of the semester promises to be a good one, in an area we haven’t covered much before: shaping the far future. In the footsteps of the Future of Humanity Institute, and Nick Beckstead‘s research on the altruistic importance of the far future, we present:
The Future of Life: a Cosmic Perspective
a talk by Professor Max Tegmark
Tuesday, March 4, 7 p.m.
Exploring how we humans have repeatedly underestimated not only the size of our cosmos (and hence our future opportunities), but also the power of our humans minds to understand it and develop technologies with the power to enrich or extinguish humanity.
Known as “Mad Max” for his unorthodox ideas and passion for adventure, his scientific interests range from precision cosmology to the ultimate nature of reality, all explored in his new popular book “Our Mathematical Universe”. He is an MIT physics professor with more than two hundred technical papers and has featured in dozens of science documentaries. His work with the SDSS collaboration on galaxy clustering shared the first prize in Science magazine’s “Breakthrough of the Year: 2003.”
For privacy advocates the last week contained something of a gut-check when the UK’s splendidly descriptive Health and Social Care Information Centre announced something of a bonanza for big data companies; the NHS’s care.data program, here, will make anonymized clinical data broadly available to researchers and commercial interests with few limitations, here.
For once, however, the US attitude to the growing big data phenomenon has appeared more robust. Writing on the White House Blog, here, Presidential counselor John Podesta announced he will be leading “a comprehensive review of the way that ‘big data’ will affect the way we live and work; the relationship between government and citizens; and how public and private sectors can spur innovation and maximize the opportunities and free flow of this information while minimizing the risks to privacy.” Results are promised in 90 days.
For health lawyers, however, the most interesting recent development has been the FTC’s denial of LabMD’s motion to dismiss, here. The LabMD complaint involves the data security practices of a clinical testing laboratory. The FTC alleged “unfair . . . acts or practices” under Section 5(a)(1) of the FTC Act. One of LabMD’s arguments for dismissal was that the specific HIPAA and HITECH statutes dealing with the health privacy and security obligations of covered entities blocked the FTC from enforcing its more general authority. According to the FTC:
Nothing in HIPAA, HITECH… reflects a “clear and manifest” intent of Congress to restrict the Commission’s authority over allegedly “unfair” data security practices such as those at issue in this case. LabMD identifies no provision that creates a “clear repugnancy” with the FTC Act, nor any requirement in HIPAA or HITECH that is “clearly incompatible” with LabMD’s obligations under Section 5.
LabMD is an important development. I have argued at length, here, that big data activities outside of HIPAA-protected space have illustrated the gaps in data protection because of the manner in which the US has regulated discrete vertical industries. LabMD suggests that the FTC is prepared to fill in the gaps.
I recently posted this draft on SSRN. Feedback much appreciated. Here is the abstract:
Fragmentation and lack of coordination remain as some of the most intractable problems facing health care. Attention has often alighted on the promise of Health care Information Technology not least because IT has had such positive impact on many other personal, professional and industrial domains. For at least two decades the HIT-panacea narrative has been persistent even though the context has shifted. At various times we have been promised that patient safety technologies would solve our medical error problems, electronic transactions would simplify healthcare administration and insurance and clinical data would become interoperable courtesy of electronic medical records. Today the IoM is positioning HIT at the center of its new “continuously learning” health care model that is in large part aimed at solving our fragmentation and lack of coordination problems. While the consensus judgment that HIT can reduce fragmentation and increase coordination has intuitive force the specifics are more complicated. First, the relationship between health care and IT has been both culturally and financially complex. Second, HIT has been overhyped as a solution for all of health care’s woes; it has its own problems. Third, the HIT-fragmentation solution presents a chicken-and-egg problem — can HIT solve health care fragmentation and lack of coordination problems or must health care problems such as episodic care be solved prior to successful deployment of HIT? The article takes a critical look at both health care and HIT with those questions in mind before concluding with some admittedly difficult recommendations designed to break the chicken-and-egg deadlock.
Historically, death has been a very simple and intuitive thing to understand – it occurs when someone stops breathing and their heart stops. Visually, it is a dramatic change that anyone can comprehend.
However, we now live in an age where machines can keep people breathing, and their hearts beating, when they would otherwise die. These medical advances have been revolutionary, and they are vital to allowing living patients to recover after severe illness or injury. On the other hand, they can make it more difficult for people to accept and understand death, because it can make dead patients “appear” alive.
Brain death refers to the irrevocable loss of all functions of the brain, including the brainsteam. Someone with brain death is just as dead as someone who has stopped breathing and whose heart has stopped. Doctors confirm brain death through a neurological examination, and once diagnosed the patient is dead. That person will never have any brain functioning and will never return to life or “wake up.”
- Stephanie Greene, After Caronia: First Amendment Concerns in Off-Label Promotion, SSRN/San Diego L. Rev.
- Bill Sage et al, How Policy Makers Can Smooth The Way For Communication-And- Resolution Programs, Health Affairs
- Tim Jost, Implementing Health Reform: Four Years Later, Health Affairs
- Nancy E. Morden et al, Choosing Wisely — The Politics and Economics of Labeling Low-Value Services, N Eng J Med
- Bill Sage, Putting Insurance Reform in the ACA’s Rear-View Mirror, SSRN/Houston L. Rev.
The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops. While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.
As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s. Prior to this development, weed management required significant skill and knowledge. Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices. Herbicide-resistant crops, by contrast, were effective and easy to use.
During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant. By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds. The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.
In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem. The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance. Continue reading
Over the holidays, a dispute about whether to withdraw life-sustaining treatment between the family of Jahi McMath, a young girl pronounced brain dead by doctors after routine tonsil surgery, and her hospital reached state and federal court and began to receive national attention. (See coverage on CNN here, Fox News here, ABC News here, NY Times here.)
Just a quick flag and comment on the latest development: that a federal magistrate judge, Donna Ryu, has ordered the hospital and family into court tomorrow morning for settlement talks. Meanwhile, suits are pending simultaneously in state court and before a federal judge. While the parties have already engaged in extensive discussions, sometimes a judge can lead parties to agreement where one seemed impossible. I’m still reviewing the case but will follow up if I have anything to add to the news coverage that comes out in the coming days.
Meanwhile, for further scholarly reading on this subject generally, see Glenn Cohen’s 2004 paper in the Harvard Negotiation Law Review.
Yesterday the CMS issued a document, Options Available for Consumers with Cancelled Policies, that describes four options available to people who received notice that their healthcare plans were cancelled. (I blogged about the cancellations here.)
The first three options aren’t newsworthy: you can buy a new plan from your insurer, buy a plan through the marketplace, or shop outside the marketplace. The fourth option is newsworthy, because the CMS has for the first time announced that people whose plans were cancelled may qualify for a hardship exemption allowing them to enroll in (cheaper) catastrophic coverage.
Not surprisingly the announcement is receiving lots of attention. Seth Chandler has a roundup of some of the early news coverage. Since he posted, Nicholas Bagley blogged here and Jonathan Adler noted the change here.
I am still digesting this interesting news, but have one contribution to the discussion so far. Many people are saying that those in cancelled plans are now “exempt” from the individual mandate, that having a plan cancelled is now itself a “hardship.” That is not quite right in a way that obscures an important aspect of this announcement. The CMS has not exempted anyone with a cancelled plan yet. Continue reading
Public skepticism about the Patient Protection and Affordable Care Act could in a sense turn out to be self-fulfilling. The success of the Exchanges will depend in large part on how many people enroll in them, that is, how many people comply with the individual mandate and sign up for insurance rather than take the tax penalty. That is why we are starting to talk more and more about how many people will wind up enrolling; it’s important. (For further reading in that vein, see Seth Chandler’s interesting post at his blog doubting that enrollment will reach projections, and John McDonough’s cautious predictions based on experience with the Massachusetts health insurance mandate.)
Many have based their projections on the Massachusetts experience, which is an interesting comparison for several reasons, for me none more than this one: the Massachusetts mandate was relatively uncontroversial. One survey showed 64% approval for the law in general and 52% approval for the mandate.
It goes without saying, but the PPACA has not enjoyed that kind of popular support, for a variety of reasons. According to a recent poll, the law enjoys only 40% approval in general and only 34% approval for the individual mandate.
In theory the law is the law, so the fact that the Massachusetts mandate was more popular than is the PPACA’s individual mandate should not affect compliance. Rather, that should be determined by the difference between the monetary penalty for non-compliance and the cost of a complying health plan. (Under the PPACA in year one, the penalty is $95 or 1% of your taxable income, whichever is higher; under the Massachusetts law in year one, it was $219. So the PPACA’s penalty is higher for those making more than $21,900 in taxable income. I haven’t compared the premiums of complying plans in Massachusetts year one to the premiums of plans on the Exchanges.)
But there is research that suggests that the controversy surrounding the law could matter for compliance. Continue reading
In 1386, a female pig was put on trial in France for causing the death of a child by tearing his face and arms. Trials such as this were not uncommon in medieval Europe. As E.P. Evans describes in The Criminal Prosecution and Capital Punishment of Animals, the same procedural rules applied to human and animal defendants, and the defense counsel for animals often raised complex legal arguments on their behalf. In this case, the sow was found guilty, and under the law of “eye-for-an-eye,” the tribunal ordered that she be maimed in the head and upper limbs and hanged in the public square.
Animals today hold a very different place in our law. As the subject of extensive legal protections and the beneficiaries of private trusts, they are no longer defendants in our courts, but rather aspiring plaintiffs.
Earlier this week, a series of habeas corpus petitions were filed on behalf of chimpanzees being held in confinement for various purposes in the state of New York. (Court documents available here). The petitions, filed on behalf of the chimpanzees by the Nonhuman Rights Project, ask the court to recognize that the chimpanzees are legal persons with a right to bodily liberty, and to order that they be moved into the care of the North American Primate Sanctuary Alliance. This is the first time that a habeas petition has been filed on behalf of an animal in the United States.
Of the many important and interesting issues raised by these petitions, I will in this post focus the significance of granting legal personhood to animals.
While courts in the US have not previously been asked to recognize an animal as a person with a common law right of liberty, they have been confronted with a remarkable number of cases in which animal species are listed as lead plaintiffs—most often in suits brought to enforce provisions of the Animal Welfare Act (AWA) and Endangered Species Act (ESA). In one such case, the Ninth Circuit ruled that the endangered bird species at issue was a party with “legal status and wings its way into federal court as a plaintiff in its own right.”
The political ripples from the poorly managed exchange roll-out likely will endure through at least one election cycle. Maybe, late night comedians will run out of material sooner. While criticism and inquiry are appropriate given the foreseeable nature of the problem (some months ago at SEALS even I was moved to highlight the OIG’s predictions that there would be little time for testing the data hub) mostly we will witness technical flaws being fashioned into a cudgel with which to beat the Affordable Care Act and its champion-in-chief.
As Ezra Klein has noted, “the politics here will be driven by the reality. If the policy continues to fail, then there’s nothing the White House can do to keep from being dragged down. Conversely, if the Web site is fixed come mid-December, and the policy begins working pretty well, then there’s no amount of Republican messaging that can make it a failure.”
Sitting here in mid-to-late November, it may be appropriate (or at least refreshing) to seek out some broader lessons that we may take away from this mess. In an illuminating post at the Commonwealth Fund blog David Blumenthal contrasted his experiences inside and outside of government and concluded that the federal government needed to reform its IT procurement system. Extrapolating even further from the current disaster Clay Shirky uses healthcare.gov to pose some fundamental questions about how managers communicate with technologists and how politicians approach Internet interaction with citizens. His “litmus test” for “whether out political class grasps the internet”? “Can anyone with authority over a new project articulate the tradeoff between features, quality, and time?” Those managing healthcare.gov failed that test.
- Alyna Chien and Meredith Rosenthal, Medicare’s Physician Value-Based Payment Modifier — Will the Tectonic Shift Create Waves? N Engl J Med
- Brendan Maher, The Affordable Care Act, Remedy, and Litigation Reform, SSRN/American University L.Rev.
- Thad Pope, Making Medical Decisions for Patients without Surrogates, N Engl J Med
- World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, 7th Rev. 2013, JAMA