Thad Pope on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Our guest this week is Thaddeus Mason Pope, Director of the Health Law Institute and Professor of Law at Mitchell Hamline School of Law. Thad is also a Ph.D. with multiple global academic posts. This week we discuss grave and complex problems in end of life care, focusing on the tragic case of Jahi McMath. Thad recently published “Brain Death Forsaken,” and offers a wealth of insight on this and similar situations. The definition of death has complex implications for insurance, reimbursement, malpractice, and even criminal law.

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.

It’s Time to Reinvigorate the Constitutional Claim for Physician Assistance in Dying

by  Norman L. Cantor

Since 1997, when the U.S. Supreme Court rejected federal constitutional challenges to New York and Washington prohibitions of assistance to suicide, the notion that a dying patient might have a constitutional right to obtain a lethal prescription has gotten short shrift.  Even when the dying patient’s claim for physician assistance in dying (PAD) has relied on state constitutional provisions, no state supreme court has ruled that state liberty or equal protection guarantees so benefit a competent, terminally ill medical patient.  See T.M. Pope, Legal History of Medical Aid in Dying: Physician Assisted Death in U.S. Courts and Legislatures,   N. Mex. L. Rev.  (2018). At least 5 state highest courts have rejected such claims.  Yet developments and insights emerging over the last 21 years in death and dying jurisprudence provide reason to reinvigorate constitutional challenges to state prohibitions on a physician’s providing a lethal substance to a competent, fatally stricken medical patient.

The first Achilles heel in current legal doctrine relates to the “liberty” concept invoked by fatally stricken claimants.   When Chief Justice William Rehnquist rejected the patients’ liberty claim in Washington v. Glucksberg, he labeled it as seeking a “right to suicide.”  That over-simplistic formulation of the constitutional claim presaged its failure.  Of course the guides to fundamental liberty, i.e., the traditions and collective conscience of the people, do not encompass “suicide.”  Suicide, broadly viewed as a choice to “prematurely cut short a viable life, usually for reasons of a transient nature and often involving depression,” has always been disdained and discouraged.  Pope, supra, at 29.  Law has customarily allowed physical intervention to prevent suicide, and has criminally punished assistance to suicide.

Rehnquist, though, was unfairly characterizing the liberty claim of dying patients.  Those dying patients in Glucksberg were not advancing a broad prerogative to terminate a life deemed unbearably unhappy.  Rather, they were asserting a fatally stricken person’s interest in medical management of the dying process and in control of the timing of an unavoidable, lurking death.  Only in the 20th century, with development of modern medical tools, did this issue really emerge.  Only then did a fatally stricken patient incur risk of a protracted dying process with accompanying suffering or degradation.  The 21st century is witnessing an expanded incidence of medically mediated death, a phenomenon warranting renewed focus on end-of-life self-determination.

The 21st century is also witnessing development in another measure of fundamental liberty – the collective conscience of the people.  Polls in 2017 show that 67% of Americans now support the concept of physician-assisted death.  Public sentiment may not be a determinative factor, but it is relevant in shaping the meaning of fundamental liberty.  Also relevant are developments in legalization of PAD as in California, Colorado, New Hampshire, Montana, and the District of Columbia. In short, a basis exists for refining and resubmitting the constitutional claim that self-determination in management of a looming, unavoidable dying process should be deemed a fundamental aspect of liberty.  Continue reading

Redefining Death in the Law

By: Gali Katznelson

Jahi McMath was issued a death certificate four years ago in California. Today, at the age of 16, she remains connected to a ventilator in an apartment in New Jersey. Jahi was declared brain dead by her clinicians at Oakland’s Children’s Hospital following a cardiac arrest after a tonsillectomy. A legal battle between Jahi’s mother and the hospital ensued, with the mother requesting that Jahi remain on life support. The hospital refused, and after the hospital released Jahi to a coroner who issued her death certificate, Jahi’s family transported her to a paediatric ICU in a New Jersey hospital. New Jersey is the only state with a law requiring hospitals to accommodate patients whose families do not accept a determination of brain death on religious grounds.

Religious objections to brain death come from some members of the Orthodox Jewish, Japanese Shinto, Native American and Muslim communities. New York, California and Illinois also mandate accommodations for religious objections to brain death but these states leave the nature of the accommodation to the discretion of individual hospitals. This is unlike New Jersey, which allows an exception to brain death criteria and imposes a duty to accommodate patients who reject brain death state-wide. Should all states enact some form of a religious accommodation to brain death? To consider the same person to be alive in one part of the country but dead in another seems illogical. But rather than adapting current laws to accommodate objections based on religion, a more coherent approach might be to redefine the nature of the law itself.

As it stands in the US, the determination of brain death by neurological criteria is equated to a legal definition of death. This history dates back fifty years, to a report by the Harvard Ad Hoc Committee on Brain Death that defined irreversible coma as a new criterion for death. Neurologic criteria for death eventually made its way into law through the 1981 Uniform Declaration of Death Act (UDDA). This model statute states that death could be determined for an individual who has sustained either irreversible cessation of circulatory and respiratory functions, or irreversible cessation of all functions of the entire brain, including the brain stem, made in accordance with acceptable medical standards. Every state has adopted some version of this statute.

Continue reading

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!

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!

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.

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!

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!

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Continue reading

New York’s Highest Court Summarily Rejects a Constitutional Challenge to New York’s Ban on Physician-Assisted Suicide

By Norman L. Cantor

Justice Cardozo, the legendary jurist from New York, would turn over in his grave upon reading the New York Court of Appeals’ per curiam (unsigned) opinion in Myers v. Schneiderman, 2017 WL 3897181 (9/17/17).  The lawsuit was filed by several terminally ill patients (and physicians serving such patients) challenging New York’s ban on physician assistance to a competent, terminally ill medical patient seeking a lethal prescription.  The deficiency that would upset Cardozo was not so much the Court’s conclusion that application of assisted suicide laws to a dying patient does not violate constitutional rights of liberty and equal protection, but rather the Court’s perfunctory, over-simplified handling of the constitutional issues.

The most plausible constitutional challenge in this context is equal protection – a claim that states act arbitrarily in allowing terminal patients certain means of hastening a grueling dying process (rejection of life-sustaining medical intervention, use of risky analgesics or sedatives to relieve suffering, and voluntarily stopping of eating and drinking (VSED)) while banning a physician’s provision of a more expeditious means of hastening death – a lethal medication.   The per curiam opinion’s dismissive response to this equal protection claim was that New York’s laws don’t differentiate among persons.   From the Court’s perspective, every competent patient is entitled to reject medical intervention and every person is forbidden to assist a suicide.  There are no invidious “discriminations” present.  This myopic formulation of the equal protection issue ducks the complex distinctions made by state laws in the context of dying medical patients.

The issue of controlling the time and manner of death derives from medical science’s newfound (mid-20th century) capacity to prolong a fatally stricken patient’s dying process – sometimes beyond the patient’s tolerance for suffering or indignity.  Patient choice and some medical management of the dying process became an accepted norm in confronting irremediably fatal pathology.   The initial accepted means of controlling the timing of unavoidable death was through patients’ control of life-sustaining medical intervention  (including chemotherapy, respirators, dialysis, or artificial nutrition and hydration).  A competent patient’s prerogative to reject medical life support has been recognized as a basic legal right in every jurisdiction.  Continue reading

Understanding the Neuroscience and Philosophy of Consciousness

By Yusuf Lenfest

Think of the last few times you’ve had a very lifelike dream. Running, reading, or having conversations with others, are all activities that might happen during a particularly vivid dream. But would this be considered consciousness? Surely being in a state of sleep is not the same as being in a waking state; but if you are able to communicate, to attend a lecture, perhaps even to give a lecture whilst you sleep, what does this mean in terms of your brain’s activity? Very deep in the sleep cycle, a person may not respond immediately to touch or sound or any other sensory stimulus. That is, they may not wake up, though it cannot be ruled out that an external stimulus might influence the sub-conscious mind and hence their dream. We’ve all had the experience of hearing an alarm “in our dream” which is really our real alarm, yet our mind re-interprets it and incorporates it into our dream until we regain consciousness, i.e., wake up. What if you couldn’t wake up from your unconscious state? And if so, what would this mean for how your brain processes your thoughts? In effect, what would it mean for your lived reality if you could only live in your mind?

Beyond being a fun thought experiment, these may be some very relevant questions now that doctors have treated a vegetative-state patient with an experimental therapy leading him to regain partial consciousness.

It was reported yesterday in National Geographic, Popular Science, the Guardian, and elsewhere that a 35-year-old man who had been in a persistent vegetative state (PVS) for 15 years has shown signs of consciousness after receiving a pioneering therapy involving nerve stimulation. The French researchers reported their findings to the journal Current Biology. Led by Angela Sirigu, a cognitive neuroscientist and director of the Institut des Sciences Cognitives Marc Jeannerod in Lyon, France, a team of clinicians tried an experimental form of therapy called vagus nerve stimulation (VNS) which involves implanting a device into the chest designed to stimulate the vagus nerve. It works by giving off miniscule electrical shocks to the vagus nerve, a critical brain signal that interfaces with parasympathetic control of the heart, lungs, and digestive tract.

So again, what does it mean to be conscious?

Continue reading

Dissecting the Charlie Gard Case

The judicial decision to allow mechanical life support to be removed from the British infant, Charlie Gard, has been roundly condemned by some sources.  The infant’s distraught mother lamented that the parents had been allowed “no control” over their child’s life and death.  Demonstrators, calling themselves “Charlie’s army,” assembled near the courthouse crying “shame” at the court’s failure to sustain a preservable human life.  Conservative commentators condemned the “unwarranted” governmental interference with parents’ child-rearing prerogatives.  They wondered why the parents weren’t permitted to transport the infant, at their own expense, from London to New York to try an experimental medication being offered by a Columbia physician.  Another conservative source accused the National Health Service of taking Charlie prisoner, contending that the British health service feared being shown up by American free enterprise medicine if Charlie were treated in New York.

The Setting

Charlie Gard was born on August 4, 2016, suffering from a rare genetic disease called mitochondrial DNA depletion syndrome (MDDS).  MDDS seriously affected Charlie’s brain and muscles, leaving him without ability to hear, see, cry, move his arms or legs, or breathe without a mechanical ventilator.  On October 11, 2016, Charlie was admitted to Great Ormond Street Hospital (GOSH) where he was continuously treated until just before his death in a hospice in July 2017.

In early January 2017, the GOSH clinicians had been willing to import and administer an experimental drug (nucleoside powder) touted by a N.Y. physician, Dr. Michio Hirano.  Nucleoside treatment had been used by Dr. Hirano for a different mitochondrial mutation (TK2), not MDDS.  However, before nucleoside treatment could be initiated, Charlie experienced brain seizures causing even more brain damage – leaving no signs of upper brain activity necessary for responsiveness and interaction with an environment.  GOSH’s staff then concluded that there was no meaningful chance that nucleoside treatment could help Charlie.  In February 2017, GOSH applied for a judicial order declaring that withdrawal of the ventilator would be in Charlie’s best interests (to shorten the pain and suffering that Charlie was probably experiencing) and therefore would be lawful.
Continue reading

Book Review: Phyllis Shacter’s “Choosing to Die” (A Story of Death by Voluntarily Stopping Eating and Drinking)

For some people, being mired in progressively degenerative dementia is an intolerably distasteful prospect.  Precipitous mental deterioration would, for them, indelibly soil the lifetime image to be left with survivors and would pose a repugnant physical and emotional burden upon caregivers.  They know that lingering in an utterly dysfunctional cognitive state can continue for many years.

One tactic to avoid prolonged dementia, after initial diagnosis, is to take steps to end one’s existence while still competent.  And one lawful method of self-arranged death is by voluntarily stopping eating and drinking (VSED).  Strict cessation of nutrition and hydration will typically precipitate death by dehydration within 10 to 14 days.  The patient will likely lapse into delirium or confusion after a number of days and remain semi-conscious or unconscious for the duration.

The VSED route is derided by some sources as a repulsive ordeal both for the patient and surrounding caregivers.  The detractors portray the process as both torturous and excessively undignified.  They envision death “by starvation” as entailing unavoidable suffering.  They perceive offensive indignity in the accompanying erosion of mental clarity (delirium) and in days of semi-conscious or unconscious lingering.  This liminal period is deemed demeaning to the patient and “a horrible vigil” for surrounding family watching the wasting patient die. Continue reading

CMS Publishes Final Rule Revising and Expanding Conditions for HHA Participation in Medicare and Medicaid

By Wendy S. Salkin

The Centers for Medicare and Medicaid Services (CMS) finalized a rule concerning home health agencies on January 9th, “Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies.” The rule has been a long time coming, since the proposed rules were set forth on October 9, 2014. This is the first time that CMS has successfully updated the home health agency (HHA) conditions of participation (CoPs) since 1989.

The aim of the final rule, according to CMS, is to “improve the quality of health care services for Medicare and Medicaid patients and strengthen patients’ rights.” The final rule

revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements.

According to CMS,

[t]hese changes are an integral part of [the Agency’s] overall effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

As is likely well known to readers, the use of home health services in the United States is widespread. According to the National Center for Health Statistics, as of 2014, there were 12,400 home health agencies in the United States and, during 2013, 4.9 million patients in the United States received and ended care from home healthcare workers. These numbers have since risen, and today in the United States there are nearly 12,600 Medicare and Medicaid-participating home health agencies and more than 5 million patients. Home health care serves a wide range of purposes. The Medicare website touts it as “usually less expensive, more convenient, and just as effective as care you get in a hospital or skilled nursing facility (SNF).” In addition to serving the aims of treating illness or injury, according to Medicare home health care “helps [patients] get better, regain [their] independence, and become as self-sufficient as possible.” Some examples of what home health care providers do with and for patients, upon doctor’s orders, include: wound care, patient and caregiver education, intravenous or nutrition therapy, injections, monitoring patient health condition, monitoring patient drug and treatment use, teaching patients how to care for themselves, and coordinating care between the patient, their doctor, and any other caregivers. Continue reading

Can the Right to Stop Eating and Drinking be Exercised via a Surrogate Acting Pursuant to an Advance Instruction?

by Norman L. Cantor

The right of a grievously stricken, competent patient to hasten death by ceasing eating and drinking is increasingly recognized. In the typical scenario, a person afflicted with a serious degenerative disease reaches a point where the immediate or prospective ordeal has become personally intolerable.  The stricken person decides to shorten the ordeal by stopping eating and drinking, precipitating death by dehydration within 14 days.  The dying process is not too arduous so long as there is a modicum of palliative care available – emotional support, lip and mouth care, and provision of a sedative if patient agitation or disorientation ensues.

A further question is whether a person can dictate a similar fatal course for his or her post-competence self by advance instruction to an agent.  The instruction would be that — once a pre-defined point of dementia has been reached — either no food or drink should be offered to the incompetent patient or no manual assistance should be provided where the patient is not self-feeding.  This post-competence SED tactic appeals to persons who view the prospective demented status as intolerably demeaning and wish to hasten their demise upon reaching that state. The legal claim would be that if a competent patient has a right to SED, the right ought to subsist post-competence when exercised by clear advance instruction.  According to this claim, just as an advance instruction to reject a respirator would be upheld as an exercise of prospective autonomy, so an instruction for cessation of nutrition should be respected.

     A person who undertakes responsibility for a demented person normally has a fiduciary duty to promote the well-being, comfort, and dignity of the ward.  A guardian who forgoes available care measures such as shelter, warmth, hygiene, and food is chargeable with unlawful neglect.  Provision of food and assistance in eating are normally part of that fiduciary obligation.  A legal exemption might apply, though, if the guardian – in discontinuing hand feeding pursuant to an advance instruction — is simply respecting the right of the ward to exercise prospective autonomy. The question becomes: Is the acknowledged right to SED exercisable by means of an advance instruction?  Continue reading

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:05am, Welcome Remarks

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

9:05 – 10:30am: The End of ObamaCare? Health Care Reform Under A New Administration

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • David Blumenthal, President, The Commonwealth Fund
  • Michael K. Gusmano, Research Scholar, The Hastings Center
  • John McDonough, Professor of the Practice of Public Health, Director of the Center for Executive and Continuing Professional Education, Harvard T. H. Chan School of Public Health
  • Abigail R. Moncrieff, Associate Professor of Law and Peter Paul Career Development Professor, Boston University School of Law
  • Moderator: Einer Elhauge, Caroll and Milton Petrie Professor of Law and Founding Faculty Director, Petrie-Flom Center, Harvard Law School

10:30 – 10:45am, Break

10:45 – 11:10am, Precision Medicine Initiative/Cancer Moonshot

11:10 – 11:35am, Common Rule Update

  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

11:35am – 12:00pm, Clinical Trial Data Sharing

  • TBD, MRCT Center at Harvard

12:00 – 12:25pm, All-Payer Claims Databases

  • Gregory D. Curfman, Editor-in-Chief, Harvard Health Publications, Harvard Medical School

12:25 – 1:00pm, Lunch

Lunch will be provided.

1:00 – 1:25pm, Defining Death, Aid in Dying, and Family Rights

  • Paul Ford, Lecturer, Harvard Medical School, Winter 2017; Director, NeuroEthics Program, Cleveland Clinic; Director of Education, Department of Bioethics, Cleveland Clinic; Associate Professor, CCF Lerner College of Medicine of CWRU

1:25 – 1:50pm, Patient Advocacy, FDA, and Right to Try

  • Jerry Avorn, Professor of Medicine, Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

1:50 – 2:15pm, Drug Pricing and Cost

  • Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School and Brigham and Women’s Hospital

2:15 – 2:40pm, Health IP

2:40 – 2:55pm, Break

2:55 – 3:20pm, Women’s Health

  • Aziza Ahmed, Professor of Law, Northeastern University School of Law

3:20 – 3:45pm, Reproductive Technology and Regulatory Oversight

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School

3:45 – 4:10pm, Legal Responses to Zika

  • George Annas, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

4:10 – 4:35pm, Flint, Water Safety, and Public Health Infrastructure

  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs

4:35 – 5:00pm, Concussion Litigation and Legislation in Sports

  • Christopher Deubert, Senior Law and Ethics Associate, Petrie-Flom Center Law and Ethics Initiative, Football Players Health Study at Harvard University

5:00pm, Adjourn

Learn More

How did our prognosticators do in predicting health law and policy developments they expected in 2016? Check out videos of all of the presentations at the 4th Annual Health Law Year in P/Review event, held in January 2016, and find out!

Register Now!

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

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.