Tag: Health Law

Biosimilars – In The Pipeline or Still a Pipe Dream?

Temple University Center for Public Health Law Research Leave a comment

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

Improving the safety of maternity care in the National Health Service (NHS) and other medico-legal matters

John Tingle Leave a comment

By John Tingle

There are some very interesting Government patient safety and access to justice policy development activities currently going on in England.

Maternity Services

In maternity services, there is a clear recognition by Government that safety is inconsistent and that there is significant scope for improvement. Our still birth rates are amongst the highest in Europe despite the National Health Service (NHS) making advances in patient safety in this area. In the National Maternity Review we are reminded that half of the Care Quality Commission (CQC) inspections of maternity services result in safety assessments that are either ‘inadequate’ (7%) or ‘requires improvement (41%) (page 22). The CQC is the independent regulator of health and social care in England.

In a speech to the Royal College of Obstetricians and Gynaecologists (RCOG) in London, the Secretary of State for Health, 17th October, 2016, Jeremy Hunt laid out plans to make giving birth safer, including maternity safety funding and other related matters. The Government’s ambition is to halve neonatal death, stillbirth, maternal death and brain injuries caused during or shortly after labour by 2030 and a series of measures were  launched. There will be a £250,000 maternity safety innovation fund and a new national Maternity and Neonatal Health Quality Improvement Programme. New maternity ratings will also be published to help improve transparency, raise standards and will give families better information about the quality of local maternity services.

A safe space Read More

CMS Prohibits Arbitration Clauses in Long-Term Care Facility Contracts

wendysalkin Leave a comment

By Wendy S. Salkin

On Wednesday, the Centers for Medicare and Medicaid (CMS)—an agency within the Department of Health and Human Services (HHS)—released a final rule that “will revise the requirements that Long-Term Care facilities [LTCs] must meet to participate in the Medicare and Medicaid programs” (1). (Almost all LTCs receive funds from Medicare or Medicaid.) This is the first time that these requirements have been “comprehensively reviewed and updated since 1991” (6)—that is, in the past 25 years. One of the most striking changes to the regulation is found in §483.65, where CMS “require[es] that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties” (12) which means that CMS is “prohibiting the use of pre-dispute binding arbitration agreements” (12). Among the reasons provided by CMS for this change is a recognition of the notable power differential between LTCs and their residents:

There is a significant differential in bargaining power between LTC facility residents and LTC facilities. LTC agreements are often made when the would-be resident is physically and possibly mentally impaired, and is encountering such a facility for the first time. In many cases, geographic and financial restrictions severely limit the choices available to a LTC resident and his/her family. LTC facilities are also, in many cases, the resident’s residence. These facilities not only provide skilled nursing care, but also everything else a resident needs. Many of these residents may reside there for a prolonged period of time, some for the rest of their lives. Because of the wide array of services provided and the length of time the resident and his/her family may have interactions with the LTC facility, disputes over medical treatment, personal safety, treatment of residents, and quality of services provided are likely to occur. Given the unique circumstances of LTC facilities, we have concluded that it is unconscionable for LTC facilities to demand, as a condition of admission, that residents or their representatives sign a pre-dispute agreement for binding arbitration that covers any type of disputes between the parties for the duration of the resident’s entire stay, which could be for many years. (402-403)

As The New York Times reported, when the rule was first proposed in July 2015, it was “aimed at improving disclosure.” But, this final version of the rule “went a step further than the draft, cutting off funding to facilities that require arbitration clauses as a condition of admission.”

Read More

Mental Health First Aid Training in Prisons, Police Departments, and the Presidential Election

wendysalkin Leave a comment

By Wendy S. Salkin

It has been widely reported and acknowledged that many incarcerated Americans live with mental illness. In 2014, the Treatment Advocacy Center and the National Sheriffs’ Association published The Treatment of Persons with Mental Illness in Prisons and Jails: A State Survey, a joint report that included the following findings:

  • In 2012, there were estimated to be 356,268 inmates with severe mental illness in prisons and jails. There were also approximately 35,000 patients with severe mental illness in state psychiatric hospitals. Thus, the number of mentally ill persons in prisons and jails was 10 times the number remaining in state hospitals.
  • In 44 of the 50 states and the District of Columbia, a prison or jail in that state holds more individuals with serious mental illness than the largest remaining state psychiatric hospital. For example, in Ohio, 10 state prisons and two county jails each hold more mentally ill inmates than does the largest remaining state hospital.

Similarly widely reported and acknowledged is that prisons often either cannot or simply do not serve the mental health treatment needs of those housed within their walls. As Ana Swanson of The Washington Post observed:

Unsurprisingly, many prisons are poorly equipped to properly deal with mental illness. Inmates with mental illnesses are more likely than other to be held in solitary confinement, and many are raped, commit suicide, or hurt themselves.

Solitary confinement is often used as a means of separating inmates living with mental illness from the rest of a prison population. As Jeffrey L. Metzner and Jamie Fellner reported in their March 2010 article, “Solitary Confinement and Mental Illness in U.S. Prisons: A Challenge for Medical Ethics”: Read More

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

John Tingle Leave a comment

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

Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

jwill 3 Comments

By Jonathan Will

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months.  In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it.  While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing.  If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.  While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect).  This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

Read More

Healthcare complaints matter: the need to improve the system

John Tingle 1 Comment

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

Regulating genetically modified mosquitoes

daliadeak 1 Comment

By Dalia Deak

Fears of spreading zika virus have renewed interest in the use of genetically modified mosquitoes to suppress disease, with recent attention focused on the UK firm Oxitec. Last week, the developing public health crisis around zika prompted the federal government to tentatively clear a small-scale field test for the first time in the United States, pending a public comment process on a draft environmental assessment submitted by Oxitec. It should be noted that a final approval for the trial will not be made until the FDA completes the public comment process.

The genetically modified insects, which are male Aedes aegypti mosquitoes, are designed to breed with the female Aedes aegypti mosquito (primarily responsible for transmitting zika, dengue fever, and other diseases) and contain a gene lethal to their offspring. The female mosquitoes lay eggs but the larvae die well before adulthood. Oxitec claims that recent tests have shown up to a 90% decrease in the population of the Aedes aegypti mosquito, with a recent test in Piracicaba (~100 miles from Sao Paulo in Brazil) showing an 82% decline. Tests have also been conducted in the Cayman Islands and Malaysia.

In the United States, Oxitec is in the process of waiting for FDA approval to conduct trials in the Florida Keys. However, this is relatively unclear and uncharted territory for the federal government in terms of what group should be responsible for the review, and the decision for the CVM jurisdiction in this case remains hotly debated. Jurisdictional debate exists between the U.S. Department of Agriculture and the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM).

Read More

Intelligent Transparency and Patient Safety: New UK Government Patient Safety Plans Launched

John Tingle Leave a comment

By John Tingle

One thing is clear when commentating on patient safety developments in the UK is that there is hardly ever a dull moment or a lapse of activity in patient safety policy development .Something always appears to be happening somewhere and it’s generally a very significant something. Things are happening at a pace with patient safety here.

On the 3rd March 2016 the Secretary of State for Health,The Rt Honourable Jeremy Hunt announced a major change to the patient safety infrastructure in the NHS with the setting  up from the 1st April 2016 of the independent Healthcare Safety Investigation Branch. In a speech in London to the Global Patient Safety Summit on improving standards in healthcare he also reflected on current patient safety initiatives.This new organisation has been modelled on the Air Accident Investigation Branch which has operated successfully in the airline industry. It will undertake, ‘timely, no-blame investigations’.

The Aviation and Health Industries
The airline industry has provided some very useful thinking in patient safety policy development when the literature on patient safety in the UK is considered. The way the airline industry changed its culture regarding accidents is mentioned by the Secretary of State in glowing terms. Pilots attending training programmes with engineers and flight attendants discussing communications and teamwork. There was a dramatic and immediate reduction in aviation fatalities which he wants to see happening now in the NHS. Read More

In Flint, Echoes of DC Lead Crisis

daliadeak Leave a comment

By Dalia Deak

The public health crisis in Flint, MI is a long way from resolved. The short-term public health effects have been staggering, a state of emergency has been declared in the city, uncertainty looms in the long-term, and the city, state, and federal government have a serious trust issue on their hands.

Last April, the city of Flint changed its water source from Lake Huron to the Flint River in an effort to reduce mounting financial pressure on the city. However, the new water source corroded the city’s old pipes, leaching lead into the water. Adding insult to injury,
when residents complained about the taste, smell, and appearance, or attributed rashes and other medical conditions to the water source, city officials told residents that they were continually monitoring the levels to ensure that they were safe (a claim which has been called into question). Despite concern over the quality of the water dating back almost immediately after the switch, a state of emergency was declared when parents started bringing children in to the pediatrician for concerns about delayed development. When researchers at Hurley Medical Center looked into the issue, they found that the proportion of infants and children with above-average lead levels close to doubled after the switch. Residents filed a class-action lawsuit against the Governor, the state, the city, and 13 public officials in November for damages from the high levels of lead in the water, claiming that their 14th amendment right was violated when the city took away their safe drinking water and replaced it with a cheaper, more dangerous alternative.

Read More