The Health Service Ombudsman: NHS Failing Patients with Mental Health Problems

By John Tingle

Failings in National Health Service (NHS) care for patients with mental health problems is a worryingly persistent story in the English media. Many reports show harrowing and dramatic failings in NHS care provision for the mentally ill some of which result in avoidable deaths.The Health Service Ombudsman  (HSO) represents the final stage in the NHS complaints procedure and is an independent  office reporting  directly  to Parliament.The HSO carry’s out investigations into complaints  and makes the final decisions on those that have not been resolved by the NHS in England.In a recently published report the HSO reveals reveals unjust, shocking and tragic failings  in NHS care provision for patients with mental health problems.Some mental health care complaints figures are given in the report.In 2016-2017 there were 14,106 complaints made to NHS mental health trusts (hospitals) with ,65% being upheld or partly upheld by the local organisation.Case work data between 2014-15 and 2017-18 was analysed and five key themes showing persistent failings that the HSO see in complaints being made emerged from this exercise:

  • Diagnosis and failure to treat.
  • Risk assessment and safety
  • Dignity and human rights.
  • Communication.
  •  Inappropriate discharge and provision of aftercare.

The HSO also points out in the report that the other common factor in the cases examined is too frequent substandard complaint handling by the NHS organisation. This adds insult to injury, compounding the impact of failings. Continue reading

Andrew Torrance on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

This week we welcome Kansas University law professor Andrew W. Torrance, who teaches and conducts research in patent law, intellectual property, innovation, and so much more! Andrew is Earl B. Shurtz Research Professor at the University of Kansas School of Law, and a winner of a 2015 University Scholarly Achievement Award at the University of Kansas.

Andrew leads us through a couple of fascinating topics on the bleeding edge of law & technology. First, he discusses the use of a page ranking-like model to value patents. Second, he introduces us to some governance and related models applied in the synthetic biology community to avoid the tragedy of the commons and supplement or replace traditional IP protection. Our conversation covers both how cutting edge technology of network analysis can help us better understand law, and how law can better govern cutting edge technology like synthetic biology.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.

Our Aging Brains: Decision-making, Fraud, and Undue Influence

Our Aging Brains: Decision-making, Fraud, and Undue Influence
April 27, 2018 7:30 AM – 12:30 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

With over 70 million Baby Boomers retiring, elder financial exploitation has been labeled the “Crime of the 21st Century.” In this half-day event, we will explore the neuroscience, psychology, and legal doctrine of financial decision-making in older adults. How does the aging brain make financial decisions, and when is it uniquely susceptible? How can courts best use science to improve their adjudication of disputes over “competency”, “capacity”, and “undue influence”? Is novel neuroimaging evidence of dementia ready for courtroom use? This conference will bring together experts in medicine, science, and law to explore these important questions and chart a path forward for dementia and the law.

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 for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Learn more about the event here!

The Danger of Speaking for the Dying Patient with “Intellectual Disabilities”

After suffering from Alzheimer’s disease for more than two decades, my grandma quietly passed away at a nursing home in California several years ago. This may sound like a story too common to tell in the United States. However, my grandma never wanted to go to a nursing home in the first place. As someone who spent the majority of her life in China, she only immigrated to the United States to reunite with her family after my grandpa passed. When her conditions first developed, her own children (my extended family who lived with her) considered her a burden and liability, and sent her away against her will – a stark violation of Confucian filial piety cherished in my culture. After being admitted to a public nursing home with very few Mandarin speaking staff and patients, her condition deteriorated rapidly, partly as a result of language barriers and general isolation from family and friends. She soon lost most of her basic functioning and remained in a borderline vegetative state for the last few years of her life.

I could not help but think about my grandma when I read a recently published piece in New York Times. In “A Harder Death for People with Intellectual Disabilities,” Tim Lahey, M.D., argues that current laws make it too difficult for the “loved ones” and legal guardians of patients with “intellectual disabilities” to make end-of-life decisions on behalf of patients who cannot speak for themselves. Based on his own experience with patients in intensive care units, he criticizes the burdensome legal procedures required in some states to allow legal guardians to “decline life-sustaining therapies” and medical providers to “avoid giving unwanted care that isn’t likely to heal” these patients. From his point of view, questions a judge may ask such as “how sure is the guardian or family member of the patient’s wishes?” and “what’s the doctors’ best estimate at a prognosis?” are slowing down the “prompt, patient-centered, bedside care that all of us deserve.” Continue reading

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness
April 18, 2018 8:30 AM – 4:30 PM
Wasserstein Hall, Milstein East AB (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Decision aids can be highly-effective tools to promote shared decision making and support patients in becoming engaged participants in their healthcare.  Join us for the first-ever convening with leaders behind a Washington experiment in certifying decision aids, as state officials, health systems, and on-the-ground implementation experts share lessons learned and discuss policy recommendations for national or statewide approaches to decision aid certification.  

Program Overview

Person-centered care presents a unique opportunity to achieve the Quadruple Aim, especially during serious illness when people are the most vulnerable. Building on the work of NQF and others, it is now clear that healthcare purchasers (states, plans, care providers) committed to person-centered care should also be committed to shared decision-making.

A number of policy initiatives have sought to increase the use of decision aids as an effective way to further shared decision making and person-centered care. Washington is the first – and so far only – state to recognize and act on this opportunity by establishing a process to certify decision aids across the health continuum, including during serious illness when people are the most vulnerable. The program will examine the Washington experience and also explore policy barriers for replication of the Washington model at the state and national levels.

This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is part of the Project for Advanced Care and Health Policy, a collaboration between the Petrie-Flom Center and the Coalition to Transform Advanced Care (C-TAC), a non-partisan, non-profit alliance of over 130 national organizations dedicated to being a catalyst to change the health delivery system, empower consumers, enhance provider capacity and improve public and private policies in advanced illness care.

Learn more about the event here!

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of March. The selections feature topics ranging from the FDA’s regular approval of cancer drugs based on single-arm studies; to delays in the completion and reporting of clinical trials under the Paediatric Regulation in the EU, to legal challenges to state drug pricing laws. A full posting of abstracts/summaries of these articles may be found on our website.

  1. DeLoughery EP, Prasad V. The US Food and Drug Administration’s use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation. Ann Oncol. 2018 Mar 1;29(3):527-529.
  2. Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study. BMJ. 2018 Mar 19;360:k831.
  3. Hwang TJ, Tomasi PA, Bourgeois FT. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study. PLoS Med. 2018 Mar 1;15(3):e1002520.
  4. Lee TT, Kesselheim AS, Kapczynski A. Legal Challenges to State Drug Pricing Laws. JAMA. 2018 Mar 6;319(9):865-866.
  5. ‘t Hoen EF, Veraldi J, Toebes B, Hogerzeil HV. Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016. Bull World Health Organ. 2018 Mar 1;96(3):185-193.
  6. Wagner J, Marquart J, Ruby J, Lammers A, Mailankody S, Kaestner V, Prasad V. Frequency and level of evidence used in recommendations by the National Comprehensive Cancer Network guidelines beyond approvals of the US Food and Drug Administration: retrospective observational study. BMJ. 2018 Mar 7;360:k668.

How to Fix Youth Sports Concussion Laws: Neuroscientific Perspectives

How to Fix Youth Sports Concussion Laws: Neuroscientific Perspectives
April 11, 2018 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

With growing neuroscientific research on sports concussions, states have revised their policies and statutes. Yet at present we have limited research on how these state sports concussion laws are working. This panel will explore the intersection of neuroscience and law in the context of preventing, detecting, and treating youth sports concussions.

Panelists

  • William Meehan, Associate Professor of Pediatrics, Boston Children’s Hospital
  • Hosea Harvey, Associate Professor of Law and Associate Professor of Political Science (by courtesy), Temple University
  • Francis X. Shen, Senior Fellow in Law and Neuroscience at 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 for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Associate Professor of Law and McKnight Land-Grant Professor, University of Minnesota Law School; Executive Director of Education and Outreach, the MacArthur Foundation Research Network on Law and Neuroscience

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 for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Policy Surveillance Summer Institute 2018

Join us for the Policy Surveillance Program’s 3rd annual Summer Institute, June 7-8. The 2018 Summer Institute will teach public health law research methods, with a focus on policy surveillance, during a two-day intensive training at Temple University in Philadelphia, PA. Policy surveillance tracks public health laws and policies over time and across jurisdictions, using a rigorous scientific process to create data for evaluation and empirical research. The Institute will consist of two tracks, introductory and advanced. The introductory track is intended for participants who are interested in learning the steps of the policy surveillance process, while the advanced track is intended for participants who are already familiar with the steps of the policy surveillance process and would like to learn the techniques and tools needed to manage a policy surveillance project. Register now!

Jamila Michener on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

A warm welcome to political scientist Jamila Michener, Assistant Professor in the Department of Government at Cornell University. Her research focuses on poverty and racial inequality in American politics. She is the author of a compelling new book, Fragmented Democracy: Medicaid, Federalism and Unequal Politics (Cambridge University Press, 2018). We discuss Medicaid’s policy and politics from her original perspective—how and why federalism (not to mention Section 1115 waivers) allows for unequal treatment of Medicaid recipients across out nation, and some of the damage to democratic institutions that result. An illuminating perspecive on both Medicaid policy and federalism, Fragmented Democracy is a great source of insights for lawyers, policymakers, and activists.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.

Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

This new post by Nicholas Bagley and Rachel Sachs appears on the Health Affairs Blog. 

Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

 Read the Full post here!

Rethinking Organ Donation: When Altruism Isn’t Enough

By: Gali Katznelson

The demand for donated organs greatly outweighs the supply. In the United States alone, there are roughly 115,000 people waiting for an organ transplant. Every ten minutes, a new person is added to the recipient list, and every day, 20 people on the list die waiting. To be an organ donor in most states, residents can choose to add their names to the donor registry through a simple online or in-person process. But this “opt-in” system is failing to entice enough people to become organ donors. Currently, 54% of Americans are on the donor registry, but very few registrants are available to donate at a given time, in large part because the vast majority of registered donors have opted to do so posthumously. Better policies are needed to encourage more people to donate, both as living donors and as registered posthumous donors. It’s time to consider a non-monetary incentive system that prioritizes those who have signed up as organ donors.

Before jumping into an incentive-based system, let’s consider other options: namely “opt-out” and “mandated choice.” Following in the footsteps of 25 countries, including Spain and Wales, states such as Connecticut and Texas have made attempts to implement “opt-out” policies. In an “opt-out” system, each person is presumed to be an organ donor unless they explicitly choose not to be. Countries with opt-out policies have donor registration rates averaging 90%. But attempts to pass such legislation in the US have been met with fierce opposition. Likely, this is due to Americans’ unique emphasis on individual rights and skepticism of government control. Moreover, in such a system, family members may question the wishes of the deceased if they are unsure that the person was aware of the policy. In such cases, the family’s wishes will likely override the seemingly ambiguous wish of the deceased.

Alternatively, a “mandated choice” system is one in which people are faced with a compulsory choice regarding organ donation. In the US, Texas first tried this in the 1990s, where checking “yes” or “no” to organ donation became a condition for obtaining a driver’s license. Without adequate public education, 80% of people chose not to donate and the law was eventually repealed. More recently, Illinois experienced success with a mandated choice system. There, anyone receiving or renewing a driver’s license or an identification card is faced with the choice of becoming an organ donor. As a result, 60% of adults have now agreed to donate. This is a good start, but we can do better.

Continue reading

ON MONDAY! Crimes of Passion: New Neuroscience vs. Old Doctrine

Crimes of Passion: New Neuroscience vs. Old Doctrine
April 9, 2018 12:00 PM
Wasserstein Hall, Milstein East C (2036)
Harvard Law School, Cambridge, MA

The criminal law often sees love and passion turned into violence. How does this happen? And how should law respond? Many doctrines, most notably the “heat of passion” defense – which historically has been used disproportionately to excuse the crimes of men against women – rely on a distinction between defendants who acted “emotionally” instead of “rationally.” But modern neuroscience has debunked the idea that reason and emotion are two entirely different mental states. This panel will explore how law should respond to this neuroscientific challenge to long-held doctrine.

Panelists:

  • Lisa Feldman-Barrett, PhD, University Distinguished Professor of Psychology and Director of the Interdisciplinary Affective Science Laboratory at Northeastern University; Research Scientist, Department of Psychiatry, Northeastern University; Research Neuroscientist, Department of Radiology, Massachusetts General Hospital; Lecturer in Psychiatry, Harvard Medical School; Faculty Affiliate, the Center for Law, Brain & Behavior, Massachusetts General Hospital

  • Jeannie Suk Gersen, JD, PhD, John H. Watson, Jr. Professor of Law
  • Judge Nancy Gertner (ret.), Senior Lecturer on Law, Harvard Law School and Managing Director, Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Moderator: Judith Edersheim, JD, MD, Co-Founder and Co-Director of the Center for Law, Brain and Behavior, an Assistant Clinical Professor of Psychiatry at Harvard Medical School, and an attending Psychiatrist in the Department of Psychiatry at  Massachusetts General Hospital

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 for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

New E-Cigarette Dataset Available on LawAtlas.org: Explore the Regulatory Landscape!

Since their introduction to the United States market in 2006, electronic cigarettes (e-cigarettes) have quickly transformed from a novelty product into a widely used device for the delivery of nicotine and flavored vapors. In 2017, a nationally representative study found that 35.8% of high school seniors reported trying “vaping,” or using e-cigarettes, in comparison to the 26.6% who reported their use of traditional, combustible cigarettes. The study also found that 18.5% of eighth graders reported trying vaping. Youth acceptance of vaping has concerned public health advocates, who worry that the impacts of the successful campaign against tobacco could be reversed if vaping makes young people more likely to initiate smoking.

As of August 1, 2017, 49 states, the District of Columbia, and U.S. federal law regulate e-cigarettes. The Center for Public Health Law Research has released a new dataset analyzing laws controlling electronic cigarettes now available on LawAtlas.org, the Policy Surveillance Program’s website dedicated to empirical legal datasets. This research reveals several important decisions that states make when regulating e-cigarettes.

First is whether e-cigarettes are regulated in the same way as traditional tobacco products. Incorporating e-cigarettes into the existing definition of “tobacco products,” is a common practice. As of August 1, 2017, 11 states and the District of Columbia consider e-cigarettes to be a tobacco product. Additionally, 12 states, the District of Columbia, and U.S. federal law also regulate e-cigarettes similarly to traditional cigarettes by including the use of e-cigarettes in their definition of smoking. This often places e-cigarettes under the control of state clean indoor air acts, which restrict the use of e-cigarettes in the same areas where smoking traditional cigarettes is prohibited.

Another important legal distinction is whether e-cigarettes must contain nicotine. Eleven states and U.S. federal law require an e-cigarette to contain nicotine in order to be legally defined as an e-cigarette. Some e-cigarettes only deliver flavored vapor and do not deliver nicotine. Therefore, definitions of e-cigarettes that require nicotine content do not regulate e-cigarettes that only deliver flavoring. While flavorings may not contain addictive chemicals like nicotine, studies have shown that certain flavoring chemicals can produce harmful reactions in users’ lungs.

The dataset also captures requirements related to online purchasing and product packaging, including child-resistant packaging and nicotine concentration labeling requirements. Child-resistant packaging is important because the nicotine concentrations in the “e-liquids” vaporized by e-cigarettes are high enough to cause nicotine poisoning if ingested or even if touched. Further, online purchasing requirements are important because many e-cigarettes are purchased online and can be shipped to underage users illegally if website vendors are not scrupulous in their screening practices. As of August 1, 2017, 12 states require age verification by a third-party service for online purchases of e-cigarettes.

As medical and scientific researchers continue to publish studies on the potential public health impacts of e-cigarettes, the state regulatory landscape may evolve further. Although many studies conclude that e-cigarettes are less harmful than traditional cigarettes, their long-term effects are still unknown. To aid this research, the new policy surveillance Electronic Cigarette Laws data set serves as a resource for tracking the regulatory response of states as the consumption of e-cigarettes continues to expand.

Systemic Oversight: a new approach for precision medicine and digital health

By Alessandro Blasimme and Effy Vayena

Imagine a clinical research protocol to test the efficacy of a nutritional regime on the aging trajectory of the participants. Such a study would need to be highly powered and include thousands of people in order to observe a credible effect size. Participants would remain enrolled in the study for many years, maybe decades. Endpoints would include novel measures of healthy aging such as functioning (the capacity to perform certain activities) and the quality of social life. Participants would thus be asked to provide enormous amounts of personal data covering at the same time their health state, their habits and their social activities – most likely with the help of smart appliances, sensor-equipped wearables, mobile phones and electronic records.

In a different scenario a research team aims to develop clinical protocols for cancer treatment according to the unique genomic signature of their tumor. They will need patients, willing to undergo whole genome germline and tumor sequencing right at the moment of diagnosis and be included in a basket trial. Therapy would then be targeted to the specific genetic alterations of each individual in the hope that a combination of targeted drugs would generate better medical outcomes than the current standard of care.

These two scenarios correspond to the prototypical form of, respectively, precision medicine and precision oncology studies. The first is likely to require large (very large) longitudinal cohorts of extensively characterized individuals – like the All of Us Research Program. The second will require sustained sharing of genomic data, information on patients’ clinical history and response to treatment, and possibly a unique repository in which such information would flow to – something akin the NCI’s Genomic Data Common.

This kind of data-intense research, in particular, introduces game changing features: increased uncertainty about foreseeable data uses, expanded temporal span of research activities due to virtually unlimited data lifecycles, and finally, the relational nature of data. This last feature refers both to the fact that, for instance, zip codes contain other types of sensitive information like information about ethnic background (redundant encoding); and to the fact that data about one person contain information about others– as is the case, for instance, with genetic data among family members. Continue reading

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness
April 18, 2018 8:30 AM – 4:30 PM
Wasserstein Hall, Milstein East AB (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Decision aids can be highly-effective tools to promote shared decision making and support patients in becoming engaged participants in their healthcare.  Join us for the first-ever convening with leaders behind a Washington experiment in certifying decision aids, as state officials, health systems, and on-the-ground implementation experts share lessons learned and discuss policy recommendations for national or statewide approaches to decision aid certification.  

Program Overview

Person-centered care presents a unique opportunity to achieve the Quadruple Aim, especially during serious illness when people are the most vulnerable. Building on the work of NQF and others, it is now clear that healthcare purchasers (states, plans, care providers) committed to person-centered care should also be committed to shared decision-making.

A number of policy initiatives have sought to increase the use of decision aids as an effective way to further shared decision making and person-centered care. Washington is the first – and so far only – state to recognize and act on this opportunity by establishing a process to certify decision aids across the health continuum, including during serious illness when people are the most vulnerable. The program will examine the Washington experience and also explore policy barriers for replication of the Washington model at the state and national levels.

This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is part of the Project for Advanced Care and Health Policy, a collaboration between the Petrie-Flom Center and the Coalition to Transform Advanced Care (C-TAC), a non-partisan, non-profit alliance of over 130 national organizations dedicated to being a catalyst to change the health delivery system, empower consumers, enhance provider capacity and improve public and private policies in advanced illness care.

Learn more about the event here!

HHS Panel Advances C-TAC and AAHPM’s Payment Models

By Mark Sterling

The Petrie-Flom Center collaborates with the Coalition to Transform Advanced Care (C-TAC) on the Project on Advanced Care and Health Policy.

Last week, a panel of experts convened by the U.S. Department of Health and Human Services (HHS) recommended approval of C-TAC’s “Advanced Care Model”, designed to improve quality and care for individuals with serious and advanced illness. The expert panel, known as the Physician-Focused Payment Model Advisory Committee or PTAC, was created by MACRA.

“With 10,000 Baby Boomers becoming eligible for Medicare every day, many of whom have or will have serious or advanced illness, we must find a way to provide quality care to this population,” said Tom Koutsoumpas, Co-Founder and Co-Chair of C-TAC, during his opening remarks. “C-TAC is honored to stand at the forefront of this exciting opportunity to transform the healthcare system. This is the first step in changing how we care for people most in need in this country.”

Continue reading

TOMORROW! Health in the Headlines: Reporting on Health Policy in the Trump Era

Health in the Headlines: Reporting on Health Policy in the Trump Era
April 4, 2018 12:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join the Center for Health Law and Policy Innovation for a panel discusison with leading health care journalists about the rapidly shifting health policy landscape in Washington DC. The panel will discuss the high drama of a tumultuous year in health policy that has seen repeated congressional attempts to repeal the Affordable Care Act, the resignation of a cabinet secretary amidst scandal, and a steady effort to undermine Obama-era priorities. Further, the panel will explore the role of journalism in modern policy-making, and how social media impacts the dialogue.

Sponsored by the Center for Health Law and Policy Innovation at Harvard Law School; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Shorenstein Center on Media, Politics and Public Policy at the Harvard Kennedy School of Government; the Harvard PhD Program in Health Policy; the Harvard T. H. Chan Student Association (HCSA) at the Harvard T. H. Chan School of Public Health; and the Harvard Health Law Society at Harvard Law School. 

Learn more about the event here!

Another Blow to Tort Reform in Florida: Statute Allowing Defendants in Medical Malpractice Suits to Hold Ex Parte Interviews with the Aggrieved Patient’s Care Providers Declared Unconstitutional

By Alex Stein

STEIN on Medical Malpractice has recently published a survey of noteworthy court decisions in the field for 2017. This survey includes an important decision, Weaver v. Myers, 229 So.3d 1118 (Fla. 2017), that voided Florida statute allowing defendants in medical malpractice suits to hold ex parte interviews with the aggrieved patient’s care providers.

The case at bar involved a medical malpractice suit filed in connection with the patient’s allegedly wrongful death. The defendants attempted to take advantage of Florida’s pre-suit discovery statute, Fla. Stat. Ann. §§ 766.106, 766.1065. This statute authorized defense attorneys to hold secret ex parte interviews with all doctors and organizations that have ever provided treatment to the deceased patient.

The Florida Supreme Court decided that this statute violates the broad constitutional right to privacy under Fla. Const. art. 1, § 23. The Court reasoned that “The ex parte secret interview provisions of sections 766.106 and 766.1065 fail to protect Florida citizens from even accidental disclosures of confidential medical information that falls outside the scope of the claim because there would be no one present on the claimant’s behalf to ensure that the potential defendant, his insurers, his attorneys, or his experts do not ask for disclosure of information from a former treating health care provider that is totally irrelevant to the claim.” The Court also clarified that “the right to privacy in the Florida Constitution attaches during the life of a citizen and is not retroactively destroyed by death. Here, the constitutional protection operates in the specific context of shielding irrelevant, protected medical history and other private information from the medical malpractice litigation process. Furthermore, in the wrongful death context, standing in the position of the decedent, the administrator of the decedent’s estate has standing to assert the decedent’s privacy rights. Finally, the Legislature unconstitutionally conditioned a plaintiff’s right of access to courts for redress of injuries caused by medical malpractice, whether in the wrongful death or personal injury context, on the claimant’s waiver of the constitutional right to privacy.”

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Continue reading

Taking action to prevent male suicide

By John Tingle

The issue of male suicide and prevention seems to have been an obscured or perhaps even a forgotten issue in reports discussing the care of vulnerable people. The UK media have recently focussed on this issue with the Project Eighty-Four campaign. This campaign  aims to raise awareness of male suicide with sculptures being placed on the top of a London tower block to mark this. The sculptures are on the top of ITV’s (Independent Television ) Buildings on London’s Southbank Promenade from 26th March 2018.The sculptures are designed to get people talking about the issue. Friends and families of the deceased men helped create them: “Each one, a poignant reminder of a real life lost and a call to society to come together and ultimately take a stand against male suicide.

BBC News has also covered the event. Project Eighty Four states that the statistics on male suicide are shocking. Every two hours a man in the UK takes his own life. Project Eighty Four is an initiative of the charity CALM (Campaign Against Living Miserably).CALM is dedicated to preventing male suicide and they say that male suicide and mental health is a big issue that cannot be ignored for any longer.

Interestingly they report in latest annual report and accounts a modest but noticeable increase in the number of female callers for help and advice. CALM’s focus is on men because of the high rate of male suicides.Helpline workers helped to directly prevent 409 suicides in 2016-17, up 19% on the previous year. Continue reading