Melinda Buntin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we welcome Melinda J. Beeuwkes Buntin, Chair of the Department of Health Policy at Vanderbilt University’s School of Medicine. She previously served as Deputy Assistant Director for Health at the Congressional Budget Office (CBO), and worked at the Office of the National Coordinator for Health IT. At RAND, Melinda served as deputy director of RAND Health’s Economics, Financing, and Organization Program and co-director of the Bing Center for Health Economics. Her research at RAND focused on insurance benefit design, provider payment, and the care use and needs of the elderly.For the lightning round, Nic discussed technological improvement of decisionmaking, both for consumers and doctors. Nic also covered CMS’s rejection of Ohio’s request for a new section 1115 demonstration (which would have charged “premiums, regardless of income, to the 600,000 individuals in Ohio’s new adult group, as well as hundreds of thousands of low income parents, foster care youth, and beneficiaries with breast and cervical cancer”).  Frank offered a counterintuitive look at the EpiPen and the present technocrat rage to privatize the VA.During the conversation, we covered some topics in CBO modeling, including Melinda’s recent paper on changes in spending by age of beneficiary. Frank mentioned some general concerns about CBO’s modeling raised by Federal Reserve economists, the GAO, Tim Westmoreland (in 2008 and 2007), Maggie Mahar, Timothy Jost, and Bruce Vladeck. We look forward to more conversations on the nature of health cost projections!

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

Petrie-Flom seeks Harvard student RA for project on human subjects research

The PFC Logo-New-Horizontal_slidePetrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science Center) on challenges and innovation in human subjects research, addressing such issues as the regulatory and ethical aspects of research using electronic and online mediums, payment of research participants, models of community engagement and patient-centered research, and participant comprehension in informed consent. The work will initially involve 6-8 hours per week for 3 months. Applicants who have completed at least one year of a graduate program in law, health policy, or a related field are particularly encouraged to apply. Please contact Luke Gelinas, PhD, lgelinas@law.harvard.edu.

The Federal Government Should Consider Medical Marijuana a Potential Ally in the Fight Against Opioid Addiction

By Shailin Thomas

The United States is in the midst of what many are calling an opioid epidemic. According to the American Society of Addiction Medicine, more than 1.9 million people in the U.S. have a substance use disorders involving prescription pain medications, and another 580,000 have substance abuse issues with heroin. The human costs of these rates of addiction are staggering.   Of the approximately 50,000 lethal drug overdoses that happen each year, almost 20,000 are the result of prescription opioids, and another 10,000 are the result of heroin. While prescription painkillers traditionally aren’t as dangerous as heroin, the connection between the two is well established. According to a 2013 survey, about 80% of heroin users started out abusing opioid painkillers.

Despite continued efforts at nearly every level of government, the rates of opioid addiction and overdose have continued to climb. However, researchers have identified an unlikely ally that may have quietly been slowing the rise of opioid use in certain states: medical marijuana.

A study recently released by Columbia University’s Mailman School of Public Health suggests that medical marijuana availability is linked to decreases in opioid usage. The study looked at opioid prevalence in autopsy reports from fatal car accidents over 14 years, and found that states that passed medical marijuana laws in that period saw a relative decrease in opioid prevalence compared to states that didn’t. While this study is making a splash, it’s just the most recent piece in a long line of research into the connection between medical marijuana availability and opioid use. One study published in Health Affairs in July showed that states which implemented medical marijuana laws between 2010-2013 saw a significant decrease in Medicare Part D prescriptions filled for medications for which marijuana is a possible alternative therapy — including opioids. Another study from 2014 showed a 25% decrease in deaths from prescription pain medication overdoses in states that implemented medical marijuana laws. Continue reading

NEXT MONTH (10/24): Health Care after the Election

presidential_nominees_slideHealth Care after the Election
October 24, 2016 12:00 PM
Wasserstein Hall, Milstein West AB (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Description

As we approach the 2016 presidential election and change of administration, there are many questions about the future of health policy that the 45th President and Congress will have to address starting in 2017. This event brings together health care experts from both sides of the aisle to discuss what health care will – and should – look like under the next administration.

Possible topics for discussion include:

  • The Affordable Care Act
  • Drug pricing
  • Delivery system reform
  • Innovation and research funding/NIH
  • Mental health
  • Public health

Continue reading

Regulating the Statutory Duty of Candour

By John Tingle

Patients are very much the weaker party in the care equation. Doctors and nurses are always in a much more powerful position as they have the command of a discrete, specialised body of professional knowledge which the patient has not got and often urgently needs. To make the National Health Service (NHS) much more patient centered and to improve the quality of care we need to take account of this imbalance in the care equation which favours healthcarers. We can do this by explaining more carefully to patients about their treatment options and respecting their autonomy as individuals.

All organisations and those working in them need to be honest, open and truthful in all their dealings with patients and the public. A statutory duty of candour now exists in law in the NHS through regulations and is enforced by the Care Quality Commission (CQC), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. The CQC can prosecute for a breach of parts 20(2) (a) and 20(3) of this regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action.

Continue reading

Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

stethoscope_computerImagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for!

But what are your obligations in approaching members of this group for recruitment? Would such recruitment be ethically advisable? Under what conditions? And what ethical norms apply when approaching sick and potentially vulnerable people for recruitment over social media? How should you (and the IRB) evaluate this type of activity from an ethical perspective?

Continue reading

Sarepta: Where Do We Go From Here?

By Rachel Sachs

This morning, the FDA finally reached a decision in the closely watched case of Sarepta Therapeutics and its drug for the treatment of Duchenne Muscular Dystrophy (DMD).  The FDA granted accelerated approval to Sarepta’s drug, Exondys, on the condition that Sarepta complete a new trial demonstrating the drug’s clinical effectiveness.  As regular FDA observers already know, Exondys’ path to approval has been highly contentious.  The key clinical trial used to support approval contained just twelve patients and no placebo, and the FDA Advisory Committee voted against both full approval of the drug and accelerated approval.  The FDA’s 126-page Summary Review, released today with their approval letter, reveals the intense disagreements within the agency over Exondys’ approval.  FDA staff scientists charged with reviewing the drug recommended against approval but were overruled by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research.  FDA Commissioner Califf deferred to her decision.

Sarepta presented the FDA with a series of bad options.  DMD is a rare, heartbreaking, and ultimately fatal genetic disease with no other real treatments, and it is clear why patients and their families would fight for access to anything that might work.  At the same time, the FDA has rarely if ever approved a drug on less evidence than that provided by Sarepta, and approving the drug might send a dangerous signal to both the public and other companies investigating rare disease drugs.  The FDA has now made its choice.  Where do we go from here?  In my view, there are at least three key issues to watch going forward. Continue reading

Monday, 9/19, HLS Health Law Workshop with Amy Sepinwall

September 19, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Challenges of Conscience in a World of Compromise”

Amy Sepinwall is Assistant Professor of Legal Studies and Business Ethics and James G. Campbell, Jr. Memorial Term Assistant Professor of Legal Studies and Business Ethics at the Wharton School at the University of Pennsylvania. Her research interests include individual and collective responsibility for corporate and financial wrongdoing, corporate constitutional rights, and gender and racial justice. Prior to joining the faculty at the Wharton School, she clerked for the Honorable Louis H. Pollak, Eastern District of Pennsylvania.

Sepinwall earned her PhD from Georgetown University and her JD from Yale Law School. She also holds MA and BA degrees from McGill University. From 2007 – 2008, she held a Charlotte Newcombe Dissertation Fellowship at the Woodrow Wilson Foundation.

Confidentiality or Public Disclosure: Trump’s Gastroenterologist and an Ethical Dilemma

By Brad Segal

“If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency,” proclaimed Dr. Harold Bornstein. The gastroenterologist’s letter, released on the candidate’s website nine months ago, stumbles from the outset with a typo (“To Whom My Concern,”), then steamrolls over the most basic descriptions of health (medical school teaches us that vital signs are, well, vital), omits information pertinent to the public discourse (why does it fail to mention the medical reason exempting Trump from the Vietnam draft?), and strangely emphases non-medicalized traits (“His physical strength and stamina are extraordinary”). Most experts agree that this medical record, if we can even call it that, is at best hyperbole. It draws grandiose conclusions without medical justification. Even Dr. Bornstein conceded, “In the rush, I think some of those words didn’t come out exactly the way they were meant.”

Just this morning the Trump campaign released a second letter from Dr. Bornstein. But this time the doctor rather humbly concludes, “In summary, Mr. Trump is in excellent physical health.”  These letters from Dr. Bornstein’s letter demonstrate a modern-day moral dilemma in providing care for a party nominee. At conflict is the physician’s professional duty to respect patient confidentiality, and his or her obligations to care for society more broadly.

First, patient-doctor confidentiality is not merely a byproduct of the law—it is a moral obligation grounded in the core tenants of the medical profession. To put it simply, if a patient comes to expect that his doctor will tell the entire community about the patient’s most embarrassing bodily defects, the patient may understandably deny his worsening symptoms of poor health at the next office visit. In the long run, erosion of trust in the medical system could endanger the public’s health–everyone is thus better off when doctors uniformly respect patient privacy. It is important to point out, however, that an informed and competent person can voluntarily waive one’s right to patient-doctor confidentiality, such as when a patient gives a physician the permission to provide updates to family members. Or when then-candidate John McCain instructed his physicians all 1,100 pages in his medical records.

Continue reading

Knowledge is Power, or Ignorance is Bliss?

By Kyle B. Brothers

You have a rare illness that seems to have a genetic cause. For years you have moved from geneticist to geneticist looking for the cause of your illness, hoping that by finding the precise genetic cause you will discover ways to alleviate your symptoms. You have had five or six genetic tests, but each one has turned up normal. Finally you visit a young geneticist fresh out of training, hoping that she will know of another test to try. She recommends the most comprehensive genetic test of all: whole genome sequencing (WGS). You are ready to immediately get this test when she poses a difficult question: WGS might reveal a cause for your illness, but it might also reveal that you are at risk for developing breast cancer, or schizophrenia, or Alzheimer’s disease. Which of these “incidental” findings do you also want to receive?

Until recently, this genomic “would you want to know” question has lived exclusively in the world of science fiction. Would you want to know what secrets your genome holds about your future? For example, would you want to know how you will die? If you knew what the future is likely to hold, would you feel fatalistic or empowered to take control of it? These questions have been the topic of compelling movies like GATTACA and classic novels like Aldous Huxley’s Brave New World. Continue reading

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

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”: Continue reading

J. B. Silvers on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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We welcomed J. B. Silvers to the podcast this week. J. B. is the John R. Mannix Medical Mutual of Ohio Professor of Health Care Finance, and Professor of Banking and Finance, at the Weatherhead School of Management, with a joint appointment in the Case Western Reserve University School of Medicine.

We asked J. B. many questions about the state of the ACA, hospitals’ adaptation to the rapidly changing policy environment, and ongoing worries about a death spiral on the exchanges. He offered refreshing and insightful perspectives on a range of live controversies in health care finance.

J. B. has served on committees at the National Academies and several national and state commissions. Until recently, he was a board member (12 years) and treasurer of the Joint Committee on Accreditation of Healthcare Organizations (TJC/JCAHO) and a board member of SummaCare Insurance Company (14 years). For seven years Silvers was a commissioner on the Prospective Payment Assessment Commission (now MedPAC) advising Congress on Medicare payment. From 1997 to 2000, while on leave, he served as President and CEO of QualChoice Health Plan and Insurance Company. He currently is vice chair of the board at MetroHealth Medical Center.

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

Medical Malpractice Under a National Health System and the ACA

By Matthew H. H. Young

What will happen to the current medical malpractice system under a single-payer system?

To answer this question, I started by looking at the information provided by Physicians for a National Health Program, whose mission is to replace the ACA (Affordable Care Act) with single-payer. On their website under Single-Payer FAQs, it says:

What will happen to malpractice costs under national health insurance?

They will fall dramatically, for several reasons. First, about one-fourth of all malpractice awards go to pay present and future medical costs (e.g. for infants born with serious disabilities). Single payer national health insurance will eliminate the need for these awards. Second, many claims arise from a lack of communication between doctor and patient (e.g. in the Emergency Department). Miscommunication/mistakes are heightened under the present system because physicians don’t have continuity with their patients (to know their prior medical history, establish therapeutic trust, etc) and patients aren’t allowed to choose and keep the doctors and other caregivers they know and trust (due to insurance arrangements). Single payer improves quality in many ways, but in particular by facilitating long-term, continuous relationships with caregivers. For details on how single payer can improve the quality of health care, see “A Better Quality Alternative: Single Payer National Health Insurance.” For these and other reasons, malpractice costs in three nations with single payer are much lower than in the United States, and we would expect them to fall dramatically here. For details, see “Medical Liability in Three Single-Payer Countries” paper by Clara Felice and Litsa Lambkros.

Let me address the most salient part of the above argument, which states that the significant burden of malpractice recoveries composed of future medical costs will be alleviated because all individuals will be insured. Continue reading

Kidneys and Livers, Made to Order?

By Seán Finan

Last week, Organovo might just have revolutionised the pharmaceutical industry. The San Diego-based company specialises in producing structures that mimic the behaviours and functions of human tissue, using 3D bioprinting. They announced last week that they were beginning the commercial manufacture and sale of their ExVive Kidney. The product models the proximal tubule of the human kidney and holds significant promise for clinical trials of new drugs. The commercialization of the ExVive Kidney follows the release of ExVive Human Liver Tissue in 2014.

In essence, Organovo is using 3D printing technology to produce samples of “human” tissue that can be used to test the toxicity of new drugs. The printing process, known as 3D bioprinting, involves extracting human cells, culturing them and suspending them in a solution. The resulting “bioink” is fed through a modified 3D printer. Layer by layer, the printer deposits cells, producing a mass with a similar structure and density to a sample of, for example, human liver. Just like “organ on a chip” technology, these synthetic liver and kidney samples present significant advantages over traditional clinical testing.

Continue reading

Vaccinate Your Children (Says a Federal Judge)

Flickr Creative Commons-Dan Hatton

Flickr Creative Commons-Dan Hatton

By Gregory M. Lipper

After nearly four years fighting about whether and when employers may exclude contraceptive coverage from employee health plans (and even block others from providing that coverage), it’s perhaps refreshing to see less controversial cases. And few healthcare-exemption cases are less controversial than those brought by parents who object to vaccinating their children. Although the challenged laws are objectively more intrusive than the contraceptive regulations—vaccination laws require parents to get the offending treatment injected into their children—courts thus far have correctly dismissed these challenges with little fanfare.

This dynamic surfaced again in a recent federal trial-court decision in California, in which the court dismissed a federal and state constitutional challenge to California legislation repealing the “personal belief exemption” to requirements that those entering schools and child-care facilities get vaccinated against diseases—including diphtheria, measles, mumps, rubella, and other dreadful ailments. The court acknowledged that eliminating the personal-belief exemption “raises principled and spirited religious and conscientious objections by genuinely caring parents and concerned citizens,” but stated that “the wisdom of the Legislature’s decision is not for this Court to decide.” Because the legislature decided to scrap the personal-belief exemption, California now exempts only those children (1) with actual medical reasons for avoiding the vaccination, (2) who are home schooled, or (3) who qualify for an Individualized Education Program under federal disabilty law. That’s a much more limited and manageable group of exemptees.

Although quite a relief for those seeking to minimize gratuitous suffering from preventable diseases, the court’s decision implicates several knotty legal issues and is worth exploring further.

Continue reading

Hospitals Should Think Before Performing Searches for Law Enforcement

In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.

While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.

It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.

Continue reading

Monday, 9/12, HLS Health Law Workshop with Patricia Zettler

September 12, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: Pharmaceutical Federalism

Patricia J. Zettler is associate professor of law at Georgia State University College of Law. She has expertise in the regulation of medicine, biotechnology and biomedical research, with an emphasis on the U.S. Food and Drug Administration. Her research focuses on the interaction between state and federal regulation of medicine and science, the challenges that innovation poses for the FDA’s regulatory scheme, and the treatment use of experimental drugs and devices outside of clinical trials. Zettler’s scholarship has appeared or is forthcoming in various legal and medical journals, including the Indiana Law Journal, San Diego Law Review, Yale Journal of Health Policy Law and Ethics, Journal of Law and the Biosciences, Boston University International Law Journal, JAMA Internal Medicine, EMBO Molecular Medicine, and Academic Medicine. Zettler teaches Torts, Health Law: Quality & Access, and Food and Drug Law.

Before joining Georgia State Law in 2015, she was a fellow at the Center for Law and the Biosciences at Stanford Law School. Prior to her fellowship, she served as an associate chief counsel in the FDA’s Office of Chief Counsel, where she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, incentives for developing antibiotics and advisory committees. Continue reading

REGISTER NOW (11/7): The Ethics of Early Embryo Research & the Future of the 14-Day Rule

egg cells flowing in a blue background

The Ethics of Early Embryo Research & the Future of the 14-Day Rule
November 7, 2016 3:00 – 6:00 PM
Austin Hall, North Classroom (100)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA
 

Description

For over 35 years, the “14-Day Rule,” prohibiting in vitro experimentation on embryos beyond 14 days, has stood as an ethical line in the sand for embryo research around the world. Throughout the arc of the rule’s existence it has not been questioned, as scientists have been unable to grow embryos in vitro either up to, or beyond, 14 days; a practical limitation that served as a backstop to the ethical rule. However, in May of this year, labs in the U.S. and the U.K. were the first to report being able to sustain human embryos in vitro for up to 13 days. This development and other advances in in vitro research involving organized, embryo-like cellular structures have raised a number of questions about the rule, its genesis, application, and future scope. This conference will convene experts in bioethics, stem cell research, embryology, and law to discuss the ethical underpinnings and future scope of the rule. Questions to be discussed include:

  • What are the historical, ethical and scientific rationales for establishing the 14-Day Rule?
  • Should the 14-Day Rule be revisited in light of recent advances?
  • Should the 14-Day Rule even apply to research involving the in vitro culture of embryo-like cellular structures?

Tentative Agenda Continue reading

Corralling the Herd: California Medical Board Acts Against Anti-Vax Doc

This summer, California’s strict new childhood immunization law, barring all exemptions except those needed for medical purposes, went into effect for public and private schools, preschools, and day cares. This law was passed as a response to the highly-publicized 2014-2015 multi-state measles outbreak that originated at Disneyland, and also in response to the growing number of California communities with large clusters of families exempting their children from vaccine requirements, putting at risk community protection from vaccine-preventable illnesses.

As I’ve written about before, both here and in articles with Tony Yang, there are many different ways to structure childhood vaccination laws. While much of the attention goes to whether or not states offer parents the right to exempt their children based on religious and/or philosophical grounds — see, for example, the recent American Academy of Pediatrics report supporting mandated vaccination for school and daycare attendance —  there are many other implementation-related details in the laws that can increase or decrease the law’s efficacy at maintaining high vaccination coverage rates. For example, some states may require that exemption requests be filed annually (increases efficacy), some states require only that a form be correctly completed (decreases efficacy), some states allow for historically anti-vax practitioners, such as naturopaths, to complete medical exemption forms (decreases efficacy, and creates a new, permanent loophole for gaining exemptions), some states require that medical exemptions be reviewed and approved by a state public health officer (increases efficacy). Continue reading