Health Equity in Housing Book Club: “Knocking on the Door”

Q&A with Christopher Bonastia, PhD

This is the first in a series of posts we will share during our research for our housing equity project. Have a suggestion for what we should read next? Let us know.

In his 2006 book, Knocking on the Door: The Federal Government’s Attempt to Desegregate the Suburbs, Christopher Bonastia, PhD, reviews the federal government’s role in perpetuating residential segregation in the United States, and its fleeting attempts to desegregate the nation’s neighborhoods.

Dr. Bonastia discusses the active role federal agencies and courts have played in creating and perpetuating residential segregation. He points to the Home Owners’ Loan Corporation, the Federal Housing Administration, the Veterans Administration, and the US Department of Housing and Urban Development as significant players in segregation and desegregation.

Understanding the roots of segregation and policy attempts to desegregate is key to understanding housing as a social determinant of health. Empirical research has shown associations between black-white segregation and an increased black infant mortality rate, elevated rates of black mortality, black homicide rates, and other negative individual and public health outcomes. Addressing racial residential segregation is imperative when attempting to improve any of those health outcomes.

Christopher Bonastia is professor of sociology at Lehman College and the City University of New York Graduate Center, as well as associate director of the Lehman Scholars Program and Macaulay Honors College at Lehman. He is the author of Southern Stalemate: Five Years without Public Education in Prince Edward County, Virginia as well as Knocking on the Door: The Federal Government’s Attempt to Desegregate the Suburbs.

Our team read Knocking on the Door during our initial research period on housing, health equity and legal levers. Continue reading below for our interview with Dr. Bonastia about this book and ongoing research in this area.

Read More

Legal Levers for Health Equity through Housing: A New Research Project

Health equity in housing can be defined as the absence of disadvantage to individuals and communities in health outcomes, access to health and social services, and quality of health and social services based on a person’s dwelling or neighborhood.

Lack of housing access, poor housing conditions, and income or racial segregation all have been shown empirically to cause negative health outcomes. Law has a pervasive role in housing, and has for a long time. Law was instrumental in creating and maintaining segregation through mechanisms like red-lining, restrictive covenants and zoning. The Civil Rights movement brought an end to explicitly discriminatory policies, and new finance and inclusionary zoning policies helped create millions of units of affordable housing, but we still have a long way to go. As Matthew Desmond’s work shows, drastic improvements are needed in how governments enforce housing codes and balance the rights of landlords and tenants. The bottom line is that too many of our people have trouble affording decent housing in neighborhoods with the amenities for healthy living, and too many of our neighborhoods are still segregated.

Our team at the Center for Public Health Law Research has been selected as a research hub in the Robert Wood Johnson Foundation’s Policies for Action Program. For the next 20 months, we will be using empirical research and legal scholarship to analyze the housing crisis through the lens of law. We know that law shapes environments and behaviors, so we are searching for the links between laws, their intended and unintended effects on the housing market, and the health outcomes that follow. We will be bringing a focus on law and its mechanisms to a field rich in policy research. Our aim is to investigate how law influences health equity in housing, and offer recommendations about how it can be a lever for greater equity. We hope to engage the community of non-profits, advocacy groups, policy think-tanks, and social scientists who are working on identifying problems and finding solutions, as well as the community of legal scholars and litigators working on housing issues. In our recommendations we plan on both identifying steps to incrementally advance housing equity through existing law, and envisioning creative changes to the legal framework itself.

We are excited to engage the housing policy and the law community in a discussion about legal levers for health equity through housing. We also look forward to sharing our work with you as we go, here and on the Policies for Action website. Please stay tuned!

If you are interested in continuing this discussion please reach out to Abraham Gutman at Abraham.gutman@temple.edu

Biosimilars – In The Pipeline or Still a Pipe Dream?

By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.

The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.

Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.

Read More

Patient Safety and Clinical Risk in Neonatal Care

By John Tingle                                     

The CQC (The Care Quality Commission)  is the independent regulator of health and adult social care in England. They make sure that health and social care services provided to people are safe, effective, compassionate, high-quality care and they encourage care services to improve. The  CQC inspects health facilities and they have important statutory regulatory powers and sanctions.They have recently produced a report on neonatal care and  on  providing care for infants in the community who need respiratory support. As well as some positive findings, the report does reveal a number of major patient safety risks and failings.

In England, one in every nine babies is born needing care from neonatal services and  this is on the increase. The care process here can be challenging with sick babies with complex health needs receiving hospital care and then care at home and in the community. The care of the baby traverses’ distinct pathways or care areas and sometimes problems can occur:

A lack of consistency in care and communication across a pathway can result in poor outcomes for both babies and parents.” (p.3)

The report looks at current practice in three different aspects of care: Read More

Child safeguarding: the National Health Service (NHS) can do much better

By John Tingle

Our children are our future and we need to look after them well. There is however a lot of evidence to suggest that we are failing our children in a number of key health areas. UNICEF in a report put the UK in 16th position – below Slovenia, the Czech Republic and Portugal – in a league table of child well-being in the world’s richest countries. The report considers five dimensions of children’s lives – material well-being, health and safety, education, behaviours and risks, and housing and environment – as well as children’s subjective well-being.

There are a number of health and other child well-being challenges for the UK to meet. The UNICEF report provides some useful context from which to view the recently published Care Quality Commission (CQC) report on the arrangements for child safeguarding and healthcare for looked after children in England.The CQC is the independent regulator of health and social care in England.Whilst the report does contain some positive findings, when read as a whole, these seem subsumed by the large number of negative findings, some of which are very worrying. Read More

California the latest to pass a Death with Dignity law, 5th in US

Medical personnel are trained to “first do no harm.” In end-of-life treatment, that simple directive can be difficult to interpret, and the legal landscape has evolved in the United States over the past 25 years. In 1990, the US Supreme Court ruled that physicians and other health care providers could withhold medical treatment at the direction of a patient or the patient’s directed agent.

Most recently, a movement to provide patients’ help in dying has been termed “death with dignity” and “assisted suicide.” Federal law does not currently address euthanasia or “mercy killings” in terminal patients who seek a physician’s aid to end their own suffering. Rather, the patient’s right to obtain a physician’s or other health care provider’s help to end their life is established by state law. Read More

Healthcare complaints matter: the need to improve the system

By John Tingle

Today consumerism is an essential part of the fabric of British society and complaint systems are heralded in many retail and professional environments. The British public have got used to complaining over the years and this attitude has seeped into the provision of health care services.

Records levels of complaints about the National Health Service (NHS) can be seen to be made every year but the NHS just does not seem to be able to get to grips with developing a good patient complaints handling system.

The Health Service Ombudsman (HSO) lies at the top of the NHS complaints structure and makes the final decisions on complaints that have not be resolved by the NHS in England. The HSO has looked into the quality of NHS complaint investigations where serious or avoidable harm has been alleged.Systemic failings in complaint, patient safety investigations were revealed. Failures which unsurprisingly have appeared in numerous complaints reports over the years before.

For the report, the HSO reviewed 150 NHS complaint investigations where avoidable harm or death was alleged. The HSO also spoke to six different trusts and surveyed over 170 NHS complaint managers to gain insights. An advisory group was later convened by the HSO to test findings.

Read More

Prior Authorization Policies for Pediatric ADHD Medication Prescriptions

According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.

In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.

In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.

The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.
States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

Read More

Looking Towards 2030 in Patient Safety

By John Tingle

There is a clear need for those charged with patient safety policy making to prepare for the future and to take account of emerging trends. This would be so in any commercial or professional organisation. These issues were addressed in the context of patient safety at the recent,Patient Safety Global Action Summit held in March 2016 in London. The conference was designed to mirror the discussions contained in the report  by NIHR (National Institute for Health Research), Patient Safety Translational Research Centre at Imperial College London and The Imperial College NHS Trust on the priorities and direction that the patient safety movement should follow going towards 2030.

There is a lot that is excellent in this report  which is very rich in analysis and detail. Lots of deep thinking about patient safety issues with interesting and novel ideas expressed on nearly every page.

Emerging threats to patient safety

In the report, in chapter one, it is acknowledged that there are many existing issues at the root of patient harm that have yet to be solved. Also that unfortunately trends in healthcare are likely to increase the risks to safety. The report focuses on four emerging trends: Read More

Amicus brief in Sequenom v. Ariosa: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

By Timo Minssen

I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent  European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we are concerned that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.

As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.

Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that  there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims (including some of Sequenom’s arguably too broad and badly drafted claims), while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.

Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.

If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs and alternative innovation incentives, such as prizes and regulatory exclusivities. This would have to be done on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Regarding regulatory exclusivities, Article 39 of the TRIPS agreement should provide sufficient leeway for such changes. The pros and cons of the different alternative approaches would of course have to be carefully considered.

The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.