The World Health Organisation (WHO) has just produced a very informative and helpful report on the need to view patient safety as a global concern and to highlight resources that they have made available to deal with the problem and those in development. Patient safety is a fundamental principle of health care and this is fully acknowledged in the report. The report begins by quoting several facts and figures which emphasize the fact that medical errors should be regarded as a matter of acute global concern:
“According to a new study, medical errors are the third leading cause of death in the United States. In the United Kingdom, recent estimations show that on average, one incident of patient harm is reported every 35 seconds. Similarly, in low- and middle income countries, a combination of numerous unfavourable factors such as understaffing, inadequate structures and overcrowding, lack of health care commodities and shortage of basic equipment, and poor hygiene and sanitation, contribute to unsafe patient care (p1).”
Approximately two-thirds of all adverse health events happen in low-and middle-income countries. Fifteen per cent of hospital expenditure in Europe can be attributed to treating patient safety accidents. Continue reading →
On Monday, the Supreme Court decided another case that enhances ERISA’s deregulatory impact, Advocate Health Care Network v. Stapleton (holding that pension plans maintained by church-affiliated organizations, including hospitals, are exempt from ERISA’s pension protections as “church plans.”). Justice Sotomayor joined the majority opinion but wrote a concurring opinion lamenting its outcome and suggesting that Congress rethink ERISA — a suggestion Justices Thomas and Ginsburg have also made in the past. Abbe Gluck, Peter Jacobson, and I wrote the following on ERISA’s increasingly outsized influence and how it poses an impediment to health reform in the Health Affairs Blog on June 2, 2017.
From our post:
The Supreme Court has once again been called on to mediate the boundaries of a far-reaching, infamously complex, federal employee benefits law. And once again this law may have an important and unanticipated effect on health care.
The main goal of this law, the Employee Retirement Income Security Act of 1974 (ERISA), was to provide uniform, federal regulation of pensions and employee benefit plans (including health care). But the law has had a far more dramatic impact on health policy beyond what Congress ever contemplated. Because ERISA pushes aside state regulation of these plans, it has impeded the states’ ability to partner with the federal government to achieve key health policy goals. ERISA has also stymied some of Congress’s goals under the Affordable Care Act, and may prove an even greater obstacle to Republican efforts to return more authority over health policy to the states. Continue reading →
In a recent story about how the health insurance marketplaces are being destabilized by the Trump administration’s vacillation, the LA Times reports:
At one recent meeting, Seema Verma, whom Trump picked to oversee the federal Medicare and Medicaid programs, stunned insurance industry officials by suggesting a bargain: The administration would fund the CSRs if insurers supported the House Republican bill to repeal the Affordable Care Act.
For what its worth, the Trump administration denied that she had done so. But if she did, is that legal? Can politicians actually offer to give money from the Federal Treasury to companies in exchange for their political support (or withhold it for lack of that support)? If Ms. Verma was corruptly offering a “quid pro quo” exchange (as TalkingPointsMemo says), that would fit the statutory definition of the crime of bribery, as I discuss in a 2016 paper, The Appearance and Reality of Quid Pro Quo Corruption. However, this case also implicates the First Amendment rights of the insurance companies to support or oppose the Obamacare repeal. Continue reading →
With help from our good friend Nathan Cortez from SMU School of Law we discuss the American Health Care Act. Nathan is a thought leader in both health law and policy and administrative law and legislation–intersecting forms of expertise particularly valuable in these turbulent times.
In addition to coming to grips with some of its complex provisions, we speculated on how it will fare in the Senate, given emerging details about working groups and Democratic bridge-building by the Gang of Three (Joe Manchin, Heidi Heitkamp, and Tim “Copper Plan” Kaine). Here Professor Cortez’s expertise on Reconciliation and the Byrd Amendment proved essential. We also, let truth be told, took the opportunity to get a few things off our collective chests!
For background on AHCA: Andy Slavitt has been a diligent collector of summaries & critical commentary. In a media environment where the lies being told about AHCA’s effects on coverage are described as “flagrant,” “bald-faced,” and “gas-lighting,” expert voices are needed now more than ever. Some predict that the class warfare embodied in the bill’s distributional effects would cause a “humanitarian crisis” if it came to pass; others worry it would undo the pillars of not merely Obamacare and Medicaid, but also employer-sponsored plans. One thing appears certain: expect bankruptcy law to renew its advance onto health law syllabi. Continue reading →
“We are delighted that Carmel will be joining the Center,” said I. Glenn Cohen, Professor of Law and Faculty Director of the Petrie-Flom Center. “Throughout her career, Carmel has focused on designing, developing, and executing large health law and policy projects. This expertise and leadership will be a strong resource for the Center as it implements the vision for its second decade.” Continue reading →
This post is part of Bill of Health’s symposium on Critical Studies Citizen Science in Biomedical Research. In this post, Giulia Frezza and Mauro Capocci offer a historical look at how workers and scientists shaped a new approach to occupational and environmental health in Italy, asking if current practices of citizen science share the lineages of such radical movements. Background on the symposium is here. You can call up all of the symposium contributions already published by clicking here.
The radical movement critique of science in the turbulent decades of 1960s-70s in Italy, is a significant episode that can be useful for a critical reappraisal of contemporary definitions of the scope and the aims of Citizen Science (CS).
In those years, the deep social transformation of Italian society also involved a new perception of science and technology which emphasized that science wasnot neutral. Far from being a tool for workers’ empowerment, it became apparent that science and technology were ideologically determined. Trespassing the orthodox boundaries of Marxism, a group of scientists advocated a new relationship between science and society, while at the same time workers understood that they needed a new alliance with scientists in order to foster real social progress. An early result of this movement was the involvement of researchers and health professionals in the struggle for better working conditions within the factory. Through their personal experience and developing hegemonic power, workers criticized the traditional notions of risk management and health protection by actively collecting data and pointing to flaws in the existing industrial systems and the science behind them. Eventually, this activism resulted in a widespread science-based “Health in the Factory” movement. At the same time, a large number of sympathetic physicians and epidemiologists engaged in social efforts to create groups and associations that lent scientific support to activists. This proved to be of paramount importance when tragic accidents happened, such as the Seveso andManfredonia chemical explosions that occurred within the span of a few months in 1976. Such tragedies proved instrumental for breaking “the illusory boundary” separating the factory and the outside world; the impact of what took place inside the production sites was far-reaching. Industrial accidents eventually connected local ecology, the city environment, families, citizens, scientists studying harmful substances in the lab, and society as a whole. These events were a turning point for spreading social awareness, allowing local struggles to turn into national developments, and resulting in the evolution of the public health system and regulations of risk prevention (exposure thresholds, health assessment of working conditions, prevention and management of industrial accidents).Continue reading →
On Monday, May 1, 2017, International Workers’ Day, thousands took to the streets across the United States to demonstrate in support of immigrants’ rights in the United States and against immigration policies recently rolled out by President Trump.
Among the Presidential Actions taken by President Trump during his first hundred days in office has been the issuance of his “Buy American and Hire American” Executive Order, issued just two weeks ago on April 18, 2017, in which the President states that “[i]t shall be the policy of the executive branch to buy American and hire American.” What is meant by “hire American” is detailed in section 2(b) of the Executive Order:
Hire American. In order to create higher wages and employment rates for workers in the United States, and to protect their economic interests, it shall be the policy of the executive branch to rigorously enforce and administer the laws governing entry into the United States of workers from abroad, including section 212(a)(5) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(5)).
All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.
There is also the concept of ‘reverse innovation’. Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Continue reading →
Policy Paradox has had four editions over 25 years and has been translated into five languages. As Stone argues in the book, “behind every policy issue lurks a contest over conflicting, though equally plausible, conceptions of the same abstract goal or value.” Recognizing the deep pluralism of values and aims, Stone wisely counsels that “the job of the policy designer…is to understand the rules of the game well enough to know the standard moves and countermoves, and to think about them strategically.”
With this theoretical structure firmly in mind, we discuss the ACA and healthcare in the world of Trump. We also asked Deborah about her article “Caring Communities: What Would it Take?,” a patient-centered, care-focused counter-narrative to technocratic quantification. Grounding present conflicts in a longer-term view of the role of policymakers in a democracy, Stone offers perspective on the future of health equity in a polity where even the basic concept of risk pooling now appears contestable.
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. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.
Ironic that the leading argument against the President’s Executive Order 13768 on Sanctuary Cities is none other than the states’ rights / coercion arguments that convinced seven Justices to make the Medicaid expansion voluntary. Backstory on this element of National Federation of Independent Business (NFIB) v. Sebelius from 2012 here, with the abstract below:
Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.
For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes by the joint dissent) decided that the Medicaid expansion created by the ACA was a “new” program to which Congress could not attach the penalty of losing all Medicaid funding for refusing to participate. NFIB signals the Roberts Court’s interest in continuing the Federalism Revolution. The Court relied on, seemingly modified, and strengthened at least two existing elements of the test for conditional spending articulated in South Dakota v. Dole. Clear notice and germaneness now appear to be folded into the newly fashioned yet undefined coercion doctrine, which relied on quantitative as well as qualitative analysis to determine that the Medicaid expansion was unconstitutionally coercive. The Court is now actively enforcing the Tenth Amendment to protect states from federal spending legislation.
NFIB raises many questions regarding implementation of the Medicaid expansion as well as the ACA. The dockets will experience the reverberations of these open questions, as well as the Court’s invitation to explore the coercion doctrine. Thanks to their success before the Court, states are no longer plaintiffs claiming coercion, powerless with a “gun to the head.” The Court’s decision grants them the option to expand Medicaid or not, leaving them with the difficult political choice upon which the lives of some of our most fragile, disenfranchised citizens will rely. We are plunged into Justice Cardozo’s “endless difficulties.”
The Department of Health in England have just published a consultation paper on the Governments proposal to introduce a Rapid Resolution and Redress Scheme (RRR) – a voluntary administrative compensation scheme for families affected by severe avoidable birth injury. Action against Medical Accidents (AvMA) the UK charity for patient safety and justice cautiously welcomes the stated intentions of the scheme but state that more thought needs to be given to the proposals. There needs to be more detail of the scheme and some serious concerns are expressed.
The case for change
There are central three policy objectives behind the (RRR) scheme:
Reducing the number of severe avoidable birth injuries by encouraging a learning culture.
Improving the experience of families and clinicians when harm has occurred; and
Making more effective use of NHS resources.
In the consultation paper, a leading policy justification for the (RRR) scheme is the success of a Swedish initiative called, ‘The Safe Delivery Care Project’ which shows evidence of a reduction of claims for severe neurological birth injury. Continue reading →
The current opiate epidemic has spurred long-overdue scrutiny on the pharmaceutical production and distribution of opiate medication, but it also raises questions of public policy and law regarding the regulation of medical access to and use of opiate medications with high potential for addiction. Expert panelists will address the challenges that arise from efforts to balance restrictions on access to opiates to limit addiction while also preserving sufficient access for legitimate medical management of pain.
David Borsook, MD, PhD, Professor in Anesthesiology, Harvard Medical School; co-director, Center for Pain and the Brain at Boston Children’s Hospital, Massachusetts General Hospital, and McLean Hospital; and affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital
Rita Nieves, Deputy Director, Boston Public Health Commission
Moderator: Amanda C. Pustilnik, JD, Professor of Law, University of Maryland Carey School of Law; affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital; and 2014-2015 Senior Fellow in Law and Applied Neuroscience as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center
This event is free and open to the public. Lunch will be provided.
Check out the new EdX course “The Opioid Crisis in America,” developed by faculty at Harvard Medical School, to learn more about opioid addiction, evidence-based treatment models, harm reduction approaches that law enforcement and public health officials are using to reduce opioid overdose deaths, and non-opioid alternatives for medical pain management. This online course is free and self-paced; the first session will be available online on March 27, 2017.
CPHLR is joining forces with the Association of Schools and Programs of Public Health (ASPPH) for a free, two-part webinar series on public health law research and policy data evaluation.
Public Health Law Research Part I: Creating and Using Open-Source Policy Data for Public Health Evaluation Research March 29 @ 12:00 pm – 1:00 pm Will introduce participants to the practice of Policy Surveillance and the various law and policy datasets available through LawAtlas and other open-source portals. REGISTER >>
Public Health Law Research Part II: Developing and Implementing a Policy Evaluation Using Open-Source Legal Data April 12 @ 12:00 pm – 1:00 pm Will introduce participants to the theory, design and implementation of a policy evaluation using policy surveillance datasets. REGISTER >>
Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.
While the effort to repeal and replace the Affordable Care Act (ACA) has taken center stage, another health-related bill has been making its way through the House without nearly as much attention. On March 2, 2017, Representative Virginia Foxx (R-NC) introduced House Resolution (HR) 1313 on behalf of herself and Representative Tim Walberg (R-MI). The bill would lift current legal restrictions on access to genetic and other health-related information. Specifically, HR 1313 targets provisions of the Americans with Disabilities Act (ADA) that prohibit employers from conducting unnecessary medical examinations and inquiries that do not relate to job performance; the Genetic Information Nondiscrimination Act’s (GINA) provisions proscribing employers from requesting, requiring or purchasing the genetic information of their employees; and GINA’s prohibition on group health insurance plans acquiring genetic information for underwriting purposes and prior to enrollment. The bill passed through the Committee on Education and the Workforce last Wednesday along strict party lines with 22 Republicans supporting the proposed legislation and 17 Democrats opposing it.
Despite the public outcry against the bill, HR 1313 may not be as far-reaching as it initially appears. First, while advocates of genetic privacy fear the worst, both the ADA and GINA contain exceptions for wellness programs that already allow employers to access at least some employee health data. Second, even if HR 1313 passes, employees would still enjoy the ADA’s and GINA’s antidiscrimination protections. HR 1313 could well give employers additional access to genetic and other health-related information about their employees but it is not a license to then use that information to discriminate.
Given the Trump Administration’s stance on immigration, it probably shouldn’t be surprising that the new health law it is touting, the American Health Care Act (AHCA), will likely have a devastating effect on immigrant and their families. Although not surprising, it should nevertheless be troubling.
Even under the ACA, noncitizen immigrants are far less likely than citizens to have health insurance. In part, this is because immigrants are poorer than the native-born population and are less likely to receive insurance through their workplace. It is also because, contrary to the contentions of its critics, the ACA does not provide any coverage to undocumented immigrants. Indeed, the Obama Administration refused to treat young immigrants who received work permits under the Deferred Action for Childhood Arrival (DACA) program as lawfully in the country and thus eligible to purchase insurance on the exchanges. In addition, the ACA kept in place the 1996 Personal Responsibility and Work Opportunity Reconciliation Act‘s (PRWORA’s) tight restrictions on immigrants’ eligibility to Medicaid and CHIP. As a result, by 2015, 7 million of the 33 million Americans without insurance were noncitizen immigrants.
Yet although the ACA leaves many immigrants uninsured, it does provide relief to some lawful immigrants. First, it permits lawfully present immigrants who are ineligible for Medicaid to purchase insurance on the exchanges, even if their incomes are below the threshold required for citizens to participate on the exchanges. Second, because immigrants have lower wages than native born citizens, those who are not barred from Medicaid or CHIP due to PROWRA are more likely than native-born citizens to benefit from the ACA’s Medicaid expansion. More generally, because of their lower wages, immigrants benefit disproportionately from the ACA’s progressivity. Continue reading →
Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.
Background: Generic Drugs And Biosimilars
Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]
To limit liability and increase predictability, scholars and policymakers have long focused on capping damages awards. In particular, they have been worried that there are many runaway jury awards for non-economic damages (i.e., pain and suffering). Because these are not based on tallies of medical bills or lost wages, these are the least predictable component of the jury’s award. Still, statutory caps on damages effectively nullify the jury’s determination (and the trial judge’s oversight) of how much to compensate a plaintiff for pain and suffering. The laws substitute an arbitrary maximum instead (which, in many states, has not adjusted with decades of inflation).
In new work with John Cambpell and Bernard Chao, I study a different way to cabin jury awards for non-economic damages. Rather than capping runaway awards ex post, some states have tried to prevent them in the first place, by manipulating what a jury hears in closing arguments. Continue reading →
Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.
Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy. But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Continue reading →