New twist in debate over resident duty hours (Part I)

By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Continue reading

NEW REPORT: Protecting and Promoting the Health of NFL Players – Legal and Ethical Analysis and Recommendations

fphs_lawethics_coverThe Football Players Health Study at Harvard University today released a set of legal and ethical recommendations to address a series of structural factors that affect NFL player health. The Football Players Health Study is a research initiative composed of several ongoing studies examining the health and wellbeing of NFL players.

The newly released report, nearly 500 pages long, is based on analysis performed over two years by researchers from the Petrie-Flom Center at Harvard Law School, and is unprecedented both in scope and focus. (Read the executive summary).

This is the first comprehensive analysis of the legal and ethical obligations of various stakeholders that influence the health of NFL players. While clinical interventions are essential, players’ health is also affected by the environment in which players work.

The report reviews and evaluates the roles of 20 relevant stakeholders, including the NFL, NFL Players Association (NFLPA), players, and Club (team) doctors.  In total, the report makes 76 recommendations.

Highlights of the key proposals are summarized below: Continue reading

Honing the Emerging Right to Stop Eating and Drinking

By Norman L. Cantor

A stricken medical patient has a well-established right to reject life-extending medical interventions.  A person afflicted with pulmonary disease is entitled to reject a respirator, a person with kidney dysfunction can reject dialysis, and a person with a swallowing disorder can reject artificial nutrition and hydration (ANH).  State and federal courts uniformly invoke competent patients’ interests in self-determination and bodily integrity to uphold a patient’s prerogative to shape their own medical course.  The patient’s right extends not just to intrusive machinery, but also to simplistic, non-burdensome medical intrusions like an I.V. tube or a blood transfusion.

Some patients facing fatal or seriously degenerative conditions seek to hasten their demise by voluntarily stopping eating and drinking (VSED) before the stage of decline when they are dependent on life-sustaining medical intervention.  They see SED as a way to shorten their ordeal by precipitating death by dehydration within 14 days while receiving mild palliative intervention to foreclose distress before slipping into a terminal coma. The SED process entails days of lingering incapacity and is a distasteful prospect for some patients.  But it is regarded by other patients as a relatively quick, peaceful, and humane way of ending a mortal struggle now deemed to be intolerably arduous.

Numerous medico-legal commentators, myself included,[1] have asserted that a stricken patient has “a right” to VSED.   These commentators associate a patient’s decision to cease nutrition and hydration with the established constitutional right to reject life-sustaining medical intervention.  They note that the fasting person is invoking bodily integrity – precluding any feeding spoon from penetrating their mouth or nutritional tube from being inserted into their body – as well as autonomy in shaping a response to a serious affliction.   They also observe that the proffered succor (in the form of forced feeding or artificial nutrition) demands medically skilled intervention generally subject to a competent patient’s control.

The formal legal authority is thin.  Commentators point to several lower court decisions where judges refused to authorize medical override of a fasting patient.  No high level judicial body has spoken to the precise issue. Continue reading

“That I Don’t Know”: The Uncertain Futures of Our Bodies in America

By Wendy S. Salkin

I. Our Bodies, Our Body Politic

On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews. Here is an excerpt from that event:

MATTHEWS: Do you believe in punishment for abortion, yes or no as a principle?
TRUMP: The answer is that there has to be some form of punishment.
MATTHEWS: For the woman.
TRUMP: Yeah, there has to be some form.
MATTHEWS: Ten cents? Ten years? What?
TRUMP: I don’t know. That I don’t know. That I don’t know.

Much has been made of the fact that President-Elect Trump claimed that women who undergo abortion procedures should face “some sort of punishment.” Considerably less has been made of the fact that our President-Elect, in a moment of epistemic humility, expressed that he did not know what he would do, though he believed something had to be done. (He later revised his position, suggesting that the performer of the abortion rather than the woman undergoing the abortion would “be held legally responsible.”)

I am worried about the futures of our bodies, as, I think, are many. That a Trump Presidency makes many feel fear is not a novel contribution. Nor will I be able to speak to the very many, and varied, ways our bodies may be compromised in and by The New America—be it through removal from the country (see especially the proposed “End Illegal Immigration Act”), removal from society (see especially the proposed “Restoring Community Safety Act”), or some other means (see especially the proposed “Repeal and Replace Obamacare Act”).

But, I am like President-Elect Trump in this way: Like him, “I don’t know.” I don’t know what to say about what will happen to our bodies or to our body politic. So instead, today, I will take this opportunity to point to one aspect of the changing face of access to reproductive technologies that has already become a battleground in the fight over women’s bodies and will, I suspect, take center stage in the debate over the right and the ability to choose in coming years. Continue reading

Loneliness as epidemic

By Wendy S. Salkin

Just a few weeks ago, The New York Times ran an article confirming that, indeed, we are facing an epidemic of loneliness. There is “mounting evidence” that links loneliness to illness, as well as “functional and cognitive decline.” What’s more, loneliness turns out to be a better predictor of early death than obesity.

Neuroscientist John Cacioppo, who has spent much of his career working on loneliness, defines “loneliness” as “perceived social isolation.” Similarly, Masi, et al. (following Russell, et al. 1980) define “loneliness” as “the discrepancy between a person’s desired and actual social relationships.” As Masi, et al., point out, there is a distinction to be made between loneliness, on the one hand, and social isolation, on the other, although the two phenomena may indeed often go together. Whereas social isolation “reflects an objective measure of social interactions and relationships,” loneliness “reflects perceived social isolation or outcast.” Following Peplau & Perlman 1982 and Wheeler, et al. 1983, they go on to point out that “loneliness is more closely associated with the quality than the number of relationships.” (It’s important and timely to note that the 2016 Nobel Laureate in Literature, Bob Dylan, brought out one application of this conceptual distinction in his song, “Marchin’ to the City,” when he sang: “Loneliness got a mind of its own / The more people around the more you feel alone.”)

The health risks posed by loneliness are several and can be severe. Loneliness can contribute to increased risk of coronary heart disease, cardiovascular disease, and stroke. In a 2016 systematic review and meta-analysis in Heart, Valtorta, et al., reported that “poor social relationships were associated with a 29% increase in risk of incident CHD [coronary heart disease] and a 32% increase in risk of stroke.” And in a March 2015 meta-analysis in Perspectives on Psychological Science, Holt-Lunstad, et al., reported that a substantial body of evidence supports the following two claims:

  1. Loneliness puts one at greater risk for premature mortality. In particular, “the increased likelihood of death was 26% for reported loneliness, 29% for social isolation, and 32% for living alone.”
  2. The heightened risk for mortality due to “a lack of social relationships” (whether reported loneliness, social isolation, or living alone) is greater than the risk due to obesity.

Continue reading

CMS Prohibits Arbitration Clauses in Long-Term Care Facility Contracts

By Wendy S. Salkin

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

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

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

Continue reading

Undiagnosed Cancer under Alabama’s Statute of Repose

By Alex Stein

Alabama Code Section 6–5–482(a) that extends to “all actions against physicians, surgeons, dentists, medical institutions, or other health care providers for liability, error, mistake, or failure to cure, whether based on contract or tort” prescribes, (inter alia) that –

“in no event may the action be commenced more than four years after such act.”

The Alabama Supreme Court interprets this provision as beginning the four-year repose period when the plaintiff suffers “legal injury” from the defendant’s malpractice. See Crosslin v. Health Care Auth. of Huntsville, 5 So.3d 1193, 1196 (Ala. 2008) (“‘[w]hen the wrongful act or omission and the resulting legal injury do not occur simultaneously, the cause of action accrues and the limitations period of § 6–5–482 commences when the legal injury occurs’” (quoting Mobile Infirmary v. Delchamps, 642 So.2d 954, 958 (Ala. 1994)). This interpretation is far more generous to plaintiffs than the conventional doctrine of repose, under which the countdown of the statutory repose period begins on the day of the physician’s malpractice even when the patient develops the resulting illness or injury later on. For my analysis of the conventional doctrine of repose, see here and here.

This plaintiff-friendly interpretation did not help the plaintiff in Cutler v. U. Ala. Health Services Foundation, — So.3d —- 2016 WL 3654760 (Ala. 2016). Continue reading

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.

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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.

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Is Gaming the Transplant List an Ethical Dilemma?

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending. Continue reading

Malpractice, Terminal Patients, and Cause in Fact

By Alex Stein

Any person interested in medical malpractice or torts in general must read the Missouri Supreme Court’s recent decision, Mickels v. Danrad, 486 S.W.3d 327 (Mo. 2016). This decision involved a physician who negligently failed to diagnose the presence of a malignant brain tumor, from which the patient was doomed to die. The patient first saw the physician when he experienced numbness, blurred vision, and headaches. The physician sent the patient to an MRI scan, which he subsequently reviewed but made no diagnosis. Eleven weeks later, the patient arrived at a hospital in an altered mental state and underwent a CT scan of his brain, which showed a malignant and incurable tumor. Four months later, the patient died of that tumor. According to patient’s oncologist – who testified as a witness in a subsequent malpractice trial – the tumor was incurable when the patient first saw the physician. The plaintiffs offered no evidence controverting that testimony. Continue reading

Divided Infringement in Patent Law and the Doctor-Patient Relationship

Regular readers of this blog (hi, Mom) will recall that I often think and write about the interaction between the divided infringement doctrine in patent law and medical method patents of various kinds.  In previous posts, I’ve written about the Federal Circuit’s efforts to assign liability for divided infringement of method patents and considered the potential impact on medical method patents (here and here) and I’ve more recently examined a district court opinion applying the Federal Circuit’s analysis to a method-of-treatment claim (here).

I’ve just posted a new essay on SSRN (here, forthcoming in IP Theory) specifically considering the role of the doctor-patient relationship in the Federal Circuit’s analysis.  Would the Federal Circuit see the doctor-patient relationship as fitting within the scope of its divided infringement analysis?  Should it?  These questions are timely, as the Federal Circuit is due to take up these issues very soon.  Briefing before the court in the Eli Lilly case I considered in my last blog post has just been completed, and the case will likely be scheduled for argument later this summer.

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

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

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

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

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

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

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

 

The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

Some Very Preliminary Thoughts on Whole Women’s Health v. Hellerstedt (Texas Abortion Case) Argument

By I. Glenn Cohen

It is always dangerous to try to glean too much from oral argument, and I have only read the transcript (no recording yet) of today’s argument in Whole Women’s Health v. Hellerstedt, and finally I filed a brief in this case on the side of the law’s challengers so I may be suffering from some motivated reasoning. But with all those caveats, here goes:

Justice Scalia’s passing seems to have radically transformed this oral argument and likely this case. The 3 firm anti-abortion votes on the court (Alito and Roberts from their questions and earlier positions, Thomas we can infer from his earlier positions) left over after Justice Scalia’s passing seemed very much to be playing a defensive game. Many of their questions were aimed at convincing others on the Court (especially Justice Kennedy, the swing voter on these matters) to remand the case back to the lower court, much more so than focusing on giving Texas an outright win.

Appellant’s Counsel Toti’s argument barely was able to get to the merits questions in the case. Instead Justices Roberts, Alito, sometimes joined by Kennedy in these questions, repeatedly asked about evidence in the record on when various clinics closed, re-opened, and what evidence there was for the reason behind it. Toti tried to make use of the timing to her advantage as did the Justices more supportive of her side, but there was a lot of push on why this element of the record was not better developed. She was also repeatedly asked questions regarding the evidence on the capacity of remaining clinics to absorb extra patients needing abortions and what was developed in the record.

The same was true to a lesser extent in Appellee’s Counsel Keller’s argument. Justice Kennedy in particular focused on a line of questioning at page 44 of the argument that may also be significant in terms of remanding the case without resolving it:

“But I thought an underlying theme, or at least an underlying factual demonstration, is that this law has really increased the number of surgical procedures as opposed to medical procedures, and that this may not be medically wise?” Continue reading

Tomorrow, 3/2! The Limits to Consumerism in Healthcare: A lecture by Mary Anne Bobinski

medical doctor comforting senior patient

The Limits to Consumerism in Healthcare: A lecture by Mary Anne Bobinski
March 2, 2016 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

It is often said that health care has moved from paternalism, in the form of “doctor knows best,” to consumerism, in which patients expect to be able to obtain treatment consistent with their values and preferences. This presentation will explore some of the limits to consumerism in health care, with a particular focus on circumstances where patient values or preferences conflict with provider values, professional ethics, or societal norms captured in legislation or court decisions. Considerable attention has been devoted to constraints on patient choice in areas such as abortion and end of life care. This presentation will focus more broadly on the justifications and techniques for constraining patient choice in areas such as access to assisted reproductive technologies, risky therapies, pre-exposure prophylaxis for HIV, and extreme plastic surgery. Although the discussion will focus on the U.S., selected examples from Australia, Canada, and the U.K. will also be considered.

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The “Ashley Treatment” – Thoughts about Avoiding Sexualization

Ashley is young woman who was born in 1997 with a severe mental and physical disability that prevented her from ever eating, walking or talking by herself. Her mental capacity was also not expected to develop further than that of an infant. In 2004, When she was six and a half years old, Ashley‘s parents and the Seattle Children’s hospital physicians who had been treating her sought to perform on Ashley a novel medical intervention that would include hormonal treatment for growth attenuation, surgical removal of her breast buds, and a hysterectomy. This surgical intervention was presented as beneficial to Ashley by allowing her parents to take care of her longer and postpone institutionalization. The removal of breast buds and hysterectomy were meant to spare Ashley the pain and discomfort of menstruation and the development of fully-developed breasts, and also to “avoid sexualization” in order to make her less vulnerable to sexual abuse when she was ultimately institutionalized. Continue reading

Should a patient have a right not to know genetic information about him or herself?

By Benjamin E. Berkman, JD, MPH

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual’s entire genome has not been without controversy.  Producing information on this scale seems to violate some of the accepted norms governing how to practice medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated.  One of these widely accepted norms was that an individual had a right not to know (“RNTK”) genetic information about him or herself.  Prompted by evolving professional practice guidelines, the RNTK has become a highly controversial topic.  The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned.

In a recent paper published in Genetics in Medicine, my coauthors and I provide some data that illuminates this and other issues. Our survey of 800 IRB members and staff about their views on incidental findings demonstrates how malleable views on the RNTK can be.  Respondents were first asked about the RNTK in the abstract: “Do research participants have a right not to know their own genetic information?  In other words, would it be acceptable for them to choose not to receive any GIFs?”  An overwhelming majority (96%) endorsed the right not-to-know.  But when asked about a case where a specific patient has chosen not to receive clinically beneficial incidental findings, only 35% indicated that the individual’s RNTK should definitely be respected, and 28% said that they would probably honor the request not to know.  Interestingly, the percentage of respondents who indicated that they do not support the RNTK increased from 2% at baseline to 26% when presented with the specific case.  The percentage of people who are unsure similarly jumps, from 1% to 11%.

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Abortion Derangement Syndrome, Missouri Edition

Flickr/Creative Commons—Nicola

Flickr/Creative Commons—Nicola

by Gregory M. Lipper

Although the biggest abortion-related news last week came from the U.S. Supreme Court, a Missouri state senator (turned Attorney General candidate) took the prize for most bizarre.

Senator Kurt Schaefer—chairman of the Missouri Senate’s interim “Committee on the Sanctity of Life”—wrote a stern letter to the University of Missouri; he suggested that state law prohibited a Ph.D student from researching the effects of Missouri’s mandatory 72-hour waiting period for women who want to have an abortion. The law he cited provides, “It shall be unlawful for any public funds to be expended for the purpose of performing or assisting an abortion, not necessary to save the life of the mother, or for the purpose of encouraging or counseling a woman to have an abortion not necessary to save her life.”

This farfetched attempt to censor academic research on the effects of government policy raises a pair of legal issues (and one psychological observation…).

First, Senator Schaefer’s interpretation of the statute is, to put it mildly, a stretch. The student isn’t going to be “performing or assisting an abortion”; she’s going to be studying abortion—more precisely, the 72 hours between when a woman seeks an abortion and is allowed to have an abortion.

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Finally, a Final Rule on Advance Care Planning

In a victory for common sense, good policy, and good care, reimbursement for end-of-life counseling was safely tucked into the 2016 Medicare Payment Rules issued by CMS last Friday. The calm adoption of advance care planning shows welcome progress from the “death panels” hysteria that plagued this sensible policy when it was first proposed six years ago. The list of advance care planning supporters is long, including: numerous physician organizations, the Centers for Disease Control and Prevention, the Institutes of Medicine, the American Hospital Association, and over 80 percent of Americans. So, what is advanced care planning and why does it matter?

Given the circus that originally surrounded it, people may be surprised to learn that this policy simply involves the addition of two billable codes to the Medicare Physician Fee Schedule. The first code, 99497, covers an initial 30-minute consultation on end-of-life planning, with a second, 99498, covering 30 additional minutes, if needed. Importantly, patients do not need to be seriously ill to access this benefit – a consultation can be scheduled at any time, for example, as part of an annual physical. During this meeting, patients discuss the kind of interventions they would want if they become critically ill, or as they approach the end of life. Such conversations enable collaboration between the patient, family, and medical team – it opens the door for an ongoing dialogue about priorities and goals of care (which may evolve over time).

Planning for the end of life matters because advances in medicine have created a dizzying array of interventions and palliative care options for people who are gravely ill. There are many clinical and psychosocial benefits to communicating one’s preferences around end of life care. In a September 2015 Kaiser Family Foundation poll, 89 percent of respondents said doctors should discuss end-of-life plans with patients – but only 17 percent had actually had such a discussion with their doctor. Formal recognition of the value of advance care planning is an important step in encouraging more patients and doctors to initiate the conversation.