Art Caplan on Companies Paying for Egg Freezing

Over at Medscape, Art Caplan has a new video critiquing some companies’ new policies to pay for women to freeze their eggs:

Facebook and Apple recently announced a new perk for female workers. They will pay to freeze their eggs, a benefit that has sparked an appropriate ethical controversy.

There is no doubt that some women at these companies will think it is a great benefit, and they are glad to have it. But I am afraid that things aren’t so simple.

Part of the reason that those companies offer egg freezing is that they don’t want women distracted from their careers by having children. One way to manage both career and motherhood is to freeze your eggs. But freezing eggs is not simple, nor is the choice to do so…

Watch the full video here.

Do hospitals have a role in population health?

Population health advocates have identified health care providers, and hospitals in particular, as key allies in the effort to create better health and longer lives for Americans nationwide. Despite a growing interest in “community-based’ models of care, hospitals remain the most visible component of the US health care system. What’s more, hospitals are where the money, not to mention many of leading brains and cultural authority, reside. Of the 17.4% of GDP that the United States invests in health care, roughly 30% goes to hospitals – more than any other spending category. Hence why people interested in population health wish to have hospitals on board as they aim to address the always-challenging social, behavior and environmental determinants of health.

But the question remains open: do hospitals really have a role in the pursuit of population health?  Continue reading

The Beginning of the Broccoli Mandate?

By Deborah Cho

In National Federation of Independent Businesses v. Sebelius, 132 S. Ct. 2566  (2012), the Court famously struck down the “individual mandate” of the ACA under the Commerce Clause.  The Chief Justice noted that the Government’s argument for regulation under the Commerce Clause — that individuals were participating in interstate commerce by not purchasing health insurance and were thereby subject to regulation — “would justify a mandatory purchase to solve almost any problem.”  He continued, “To consider a different example in the health care market, many Americans do not eat a balanced diet.  [The] failure of that group to have a healthy diet increases health care costs, to a greater extent than the failure of the uninsured to purchase insurance . . . Under the Government’s theory, Congress could address the diet problem by ordering everyone to buy vegetables.”

This hypothetical was raised as an example of a potential absurd result of accepting the Government’s line of reasoning in this case.  It was provided as an extreme outcome to catch the reader’s attention.  Justice Ginsburg even responded to this “broccoli horrible” hypothetical by stating that the Court would have to accept a lengthy chain of inferences, something that the Court has refused to do in the past, to find that a vegetable-purchase mandate would affect health-care costs.  Some of those inferences included accepting that individuals would eat the vegetables rather than throw them away once purchased, that they would cut back on other unhealthy foods, and that the healthy diet would not be offset by an individual’s lack of exercise.  In addition to this piling of inferences, Justice Ginsburg noted that the democratic process would serve as a “formidable check” to prevent a situation such as the broccoli horrible.   Discussions about this broccoli mandate outside the courtroom were framed similarly.  One article from 2012 stated that Congress would need to be “crazy” to pass such legislation and that “absurd bills like a broccoli mandate are likely to fail other constitutional tests.”

Yet, here we are, just a couple years later, and it seems that some of the weakest and most vulnerable in our population have indeed found themselves in the midst of the broccoli horrible.  Continue reading

First Circuit Upholds ACA’s Medicaid Maintenance-of-Effort Provision Against Constitutional Challenge

By Rachel Sachs

Last week, the First Circuit Court of Appeals upheld the ACA’s maintenance-of-effort provision against a constitutional challenge brought by the Maine Department of Health and Human Services. The court’s opinion has received relatively little media attention, but it should be of interest to all in the health policy space. Its post-NFIB v. Sebelius Spending Clause analysis will be relevant to scholars who are interested in King v. Burwell, challenging the grant of subsidies on health insurance exchanges run by the federal government. Its procedural posture will fascinate those who are interested in plural executive systems. And its fulsome discussion of the Medicaid program and its history will be of broader interest to health policy scholars.

States participating in Medicaid must agree to cover certain groups of people up to certain income thresholds, but states may choose to expand these groups in various ways. Relevant to this case, most states have increased the income thresholds for covering children or pregnant women through the SCHIP program (sometimes quite substantially), and some have extended SCHIP to include low-income 19- and 20-year-olds. Maine had done both, providing coverage to 19- and 20-year-olds since 1991. The ACA subsequently included a maintenance-of-effort provision (42 U.S.C. § 1396a(gg)), requiring states participating in Medicaid to maintain their eligibility standards through 2019. As such, in 2012 HHS denied Maine’s request to stop providing coverage to 19- and 20-year-olds.

Maine’s Department of Health and Human Services sought review in federal court. Maine’s executive branch was not united in this choice: the Attorney General declined to represent the state and even intervened on the side of HHS Secretary Burwell. This mirrors a phenomenon that was often observed in the context of the Medicaid expansion, in which several states whose Attorneys General joined the legal fight against the expansion in NFIB subsequently expanded anyway, as that separate power was exercised by Governors and legislatures.  Continue reading

College Athletic Trainers Report Being Bullied

By Christine Baugh

A recent study indicates that college athletic trainers feel bullied on the job. The study, published in the Journal of Athletic Training, surveyed 723 collegiate athletic trainers, and found that approximately 15% of them felt that they were the victim of workplace harassment and about 20% had witnessed an instance of workplace bullying. Although there were no differences found in who was bullied, the bullies were identified as predominantly male and were most often coaches. A related examination of the perceptions of bullying in this environment, consisting of semi-structured qualitative interviews with select collegiate athletic trainers, identified structural factors associated with increased bullying and suggested workplace training as a potential solution.

The findings of these studies are in line with previous work describing the college sports medicine working environment as fraught with conflicts of interest (discussed in a previous blog post: here). However, the prevalence of bullying found in this study is actually lower than found in other studies examining bullying in other medical workplaces. That said, NCAA guidance suggests that medical professionals, including athletic trainers, should be given “unchallengeable authority” with regards to medical decision-making in the college sports medicine setting. Bullying in the college sports medicine setting occurred more frequently, according to the recent studies, when there was administrative indifference that allowed individuals who “lack respect for the athletic training professional” to act on his feelings.

Given the primary role of the athletic trainers as healthcare providers in the college sports medicine setting, it is possible that the hostility experienced in the workplace ultimately affects collegiate athlete health outcomes. Future research examining the interaction between athletic trainer workplace experience and athlete health outcomes is needed, as are interventions to ensure that athletic trainers are allowed to provide healthcare to collegiate athletes without external impediment.

Short-Term Emergency Commitment Laws Require Police to Assess Symptoms of Mental Illness

By Leslie Allen, JD

On November 20, 2014, the Public Health Law Research program released a new 50-state dataset analyzing state law governing the short-term emergency commitment process. These laws give law enforcement officers and others the right to involuntarily admit someone into a mental health care facility if they are in danger of harming themselves or others because of a mental illness.

In 47 states, police may take a person into custody without a warrant, and may initiate an emergency psychiatric hold – essentially committing them to a mental health institution without their consent. Recently, the media has increasingly examined how the police interact with the mentally ill (for example, “Police Taught to Spot Signs of Psychiatric Crisis” from FoxNews, republishing from the  Associated Press, “Police Confront Rising Number of Mentally Ill Suspects” from The New YorkTimes, and see “Where the Police are Part of Mental-Health Care” from The Atlantic). Much of the police forces’ relationship with the mentally ill is established by the laws governing civil commitment.

Police officers serve as first responders for mental health crisis treatment by legislation in nearly every state. Continue reading

The Ethics of Using Placebo Controls in Ebola Clinical Trials

[Blogger's Note: I am very pleased to share this post by my colleague at Seton Hall Law, Carl Coleman. This post was cross-posted at Health Reform Watch.]

By Carl H. Coleman

With well over 5,000 global deaths from Ebola already reported, drug developers are working fast to begin human clinical trials of promising experimental treatments.  Earlier this month, US government officials announced plans to launch a study of multiple Ebola interventions at the NIH Clinical Center, Emory University, and the University of Nebraska.  Shortly thereafter, the international relief organization Médecins sans Frontières (MSF) announced that it would soon begin testing of three experimental interventions at its treatment centers in West Africa, in collaboration with a coalition of European partners and the World Health Organization.

As predicted in an earlier blog post, a major area of contention in these trials involves the ethical acceptability of using placebo controls.  Plans for the US study are to give some participants the experimental drugs and others placebos, with everyone receiving the best supportive care available, such as fluid replacement and medications to fight off other infections.  In the MSF trials, by contrast, none of the participants will be given placebos; instead, everyone will receive one of three different experimental interventions.

From a methodological perspective, it is easy to see why the designers of the US study have chosen to use placebos.  Placebo-controlled trials are widely considered the “gold standard” of clinical research.  Using placebos makes it possible to identify the extent to which observed outcomes in participants are the result of the experimental intervention, as opposed to factors such as access to better health care facilities, receipt of supportive care, or psychological expectations (the so-called “placebo effect”).  Continue reading

United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part II)

By Joan H. Krause
[Cross-posted at HealthLawProf Blog]

In a prior post, I discussed the Seventh Circuit’s decision in United States v. Nayak, one of the first major “honest services” mail and wire fraud cases to arise since the Supreme Court decidedSkilling v. United States in 2010. In Skilling, the Court found clear Congressional intent to limit honest services prosecutions to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407, emphasis added) As I warned in a 2012 article, the Court’s focus on bribery and kickback activity within the context of a fiduciary duty might have wide-ranging consequences in the health care field given the nature of the physician-patient relationship.

The structure of honest services cases differs from that of more traditional forms of mail and wire fraud, which usually involve perpetrators who defraud victims of money or property. In contrast, these “intangible rights” cases eliminate the requirement that the victim suffer a financial loss to the perpetrator. Nonetheless, such fraud is actionable only when the perpetrator in fact owes a heightened duty to provide “honest services” to the victim. While Skilling grounded that duty in a fiduciary relationship, the majority offered little guidance as to which aspects of the relationship were most important. As Justice Scalia noted in his concurrence: “None of the ‘honest services’ cases . . . defined the nature and content of the fiduciary duty central to the ‘fraud’ offense. There was not even universal agreement concerning the source of the fiduciary obligation – whether it must be positive state or federal law . . . or merely general principles, such as the ‘obligations of loyalty and fidelity’ that inhere in the ‘employment relationship.’” (Skillingat 416-17)

The indeterminacy of the fiduciary requirement has particular relevance in the medical context. While the physician-patient relationship is commonly described as a fiduciary one, the characterization is far more complex than may first appear. The disparities in medical knowledge, as well as the inability of patients to access many services (such as prescription drugs) without physician involvement, give physicians a great deal of power over their patients – a characteristic fiduciary responsibility. Yet the relationship lacks other fiduciary hallmarks; the physician, for example, lacks the fiduciary’s traditional control over the beneficiary-patient’s money. Skilling offered little guidance as to which of these characteristics is most relevant to the honest services duty.  Continue reading

Call for Abstracts: 2015 Petrie-Flom Annual Conference – Law, Religion, and American Health Care

Abstracts due next Monday, December 1, 2014:

SCOTUSfrontThe Petrie-Flom Center invites abstracts for its 2015 Annual Conference: “Law, Religion, and American Health Care.” The conference will be held at Harvard Law School on May 8 and 9, 2014.

This conference, and anticipated edited volume, will aim to: (1) identify the various ways in which law intersects with religion and health care in the United States; (2) understand the role of law in creating or mediating conflict between religion and health care; and (3) explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

For a full conference description, including the call for abstracts and registration information, please visit our website.

The conference seeks to address the following topics. Please note that this list is not meant to be exhaustive; we hope to receive papers related to the conference’s general theme, but not specifically listed here:  Continue reading

“Proximate Cause” and the Patient Suicide Problem

By Alex Stein

This difficult problem and the underlying human tragedy have recently been adjudicated by the Supreme Court of Mississippi in Truddle v. Baptist Memorial Hosp.-Desoto, Inc., — So.3d —- (Miss. 2014).

A hospital patient suffering from a number of illnesses became agitated and aggressive. He took the IV out of his arm and attempted to leave the hospital. When nurses stopped him and forced him back to his room, he hallucinated that someone was trying to rape him. Despite these psychiatric symptoms, the patient was discharged and treated as an outpatient. During his outpatient treatment, he complained to his doctor that the medications he was taking “make him crazy.” Six days after his release from the hospital and two days after his last outpatient appointment, the patient barricaded himself in his bedroom and committed suicide.  Continue reading

United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part I)

By Joan H. Krause
[Cross-posted at HealthLawProf Blog]

Since the early 1900’s, the federal mail and wire fraud statutes have been applied to schemes to defraud victims not just of money or property, but also of “intangible rights” such as the right to the “honest services” of an employee or public servant. 18 U.S.C. §§ 1341, 1343, 1346. This expansive theory of honest services fraud has been applied to public officials and private businessmen, although only rarely to physicians or others in the health care system. In 2010, the Supreme Court used the case of former Enron CEO Jeffrey Skilling to impose significant limits on the reach of the honest services fraud theory. Skilling v. United States, 561 U.S. 258 (2010).Skilling itself had nothing to do with health care, arising instead from a prosecution for conspiracy, securities fraud, wire fraud, false representations to auditors, and insider trading in connection with Enron’s massive financial meltdown. Yet in rejecting Skilling’s vagueness challenge to the honest services wire fraud theory underlying his conspiracy conviction, the Court read the statute to limit honest services prosecutions to cases involving bribery and kickbacks – activities with particular salience in the health care context. In a 2012 article, I predicted that while Skilling generally was viewed as narrowing the scope of honest services fraud, the decision might have the paradoxical effect of inviting additional prosecutions in the health care industry.

While intangible rights cases date back to the early 1900’s, modern prosecutions were derailed in 1987 when the Supreme Court ruled that the mail and wire fraud statutes applied only to the deprivation of property rights. McNally v. United States, 483 U.S. 350 (1987). In response, Congress quickly enacted 18 U.S.C. § 1346 to clarify that the statutes did indeed prohibit “a scheme or artifice to deprive another of the intangible right of honest services.” The amendment did not include a definition of honest services, nor offer any other indication as to when the prohibition might apply. In his appeal, Skilling asserted that the provision was unconstitutionally vague because it failed to adequately define the prohibited behavior and granted nearly unfettered prosecutorial and judicial discretion. The Court, however, declined to overturn the statute, finding clear Congressional intent to return to the state of the law prior to McNally: a “solid core . . . involv[ing] offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407)

Given the prominence of kickback concerns in health care, I warned that the Court’s focus on kickbacks and bribery might well have the effect of reinvigorating the prosecution of health care intangible rights violations. And indeed on October 20, 2014, the Seventh Circuit decided one of the first major post-Skilling honest services fraud cases involving health care providers, United States v. Nayak. Continue reading

Upcoming Deadline: Submissions for The Journal of Law and Biosciences

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish The Journal of Law and Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal.  JLB includes a New Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools.  The Petrie-Flom Center is responsible for providing the New Developments for one issue per annual volume.  Last year’s contributions may be viewed here.

We are currently seeking Harvard graduate students to contribute New Developments for JLB’s Volume 2, Issue 2 (2015). Interested students from any Harvard school should submit a topic proposal (1 paragraph to 1 page) outlining the new development they wish to cover, along with their current CV, and a short writing sample (5-10 pages), by November 30, 2014. Update: Student contributions may be co-authored, particularly with students from different schools within Harvard. Proposals should be sent to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Four proposals will be selected by December 15, 2014, with one alternate.  Outlines will be due January 19, 2015.  First drafts will be due February 16, 2015, with edits returned by March 2, 2015, and final submissions due to the publisher by April 30, 2015 for publication in July.

New Developments are limited to 4500 words, inclusive of footnotes and references, and formatted according to Blue Book style.  Students will be responsible for reviewing the drafts of other student contributors, and will also receive feedback from the Petrie-Flom Center.  Please keep in mind that New Developments are not full student Notes.  They should focus on describing the policy issue at hand, why it is relevant to scholars and practitioners, and providing analysis/questions for further consideration.

Questions?  Please contact Holly Fernandez Lynch, hlynch@law.harvard.edu

Hospitable Hospitals and the True Cost of VIP Rooms

By Vadim Shteyler

Increasing hospitality in medical facilities is not a recent trend. We take for granted that modern hospitals offer clean sheets, towels, a plethora of toiletries, heated blankets, and many other amenities. Conversely, in the hospitals of decades past, many patients relied on family members to bring food and clean sheets. Rows of hospital beds in an open ward precluded privacy. Unhygienic conditions commonly resulted in rodent infestations. And paternalism in medicine was still the norm.

This trend towards hospitality has recently gained new momentum. As featured in a recent article in Kaiser Health News, dozens of hospitals have hired Chief Patient Experience Officers from customer service or hotel industries. Since 2012, when Medicare began penalizing hospitals for poor patient experiences, hospital efforts to improve patient satisfaction have grown. Some hospitals began mandating communication seminars, encouraging nurses to spend more face-to-face time with patients, and calling patients after discharge to follow-up on their recovery. The Affordable Care Act (ACA), further tying hospital reimbursements to patient surveys, has additionally promoted such changes.

A similar trend has arisen with the increased popularity of V.I.P. sections in many hospitals. Though the hospital construction boom is beginning to slow down, the resultant V.I.P. rooms remain. Lenox-Hill Hospital’s maternity suite in New York City, which received a lot of media attention after Beyonce gave birth there in 2012, is one of many luxurious suites across the nation. Some, offering personal shoppers, private chefs, and salon services, are priced upwards of $4,000. While nobody calls for a return to the hospitals of old, many feel suites such as these are excessive.  Continue reading

The Learned Intermediary Rule and Direct-to-Consumer Advertising

By Zachary Shapiro

In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has no corresponding duty to directly warn the patient.

This rule has been justified by the belief that the prescribing physicians is “in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.” Larkin v. Pfizer, Inc. 153 S.W.3d 758, 763-764 (Ky. 2004). Furthermore, historically, pharmaceutical manufacturers lacked effective means to communicate directly to patients. Courts did not want to extend liability when pharmaceutical companies were complying with FDA regulations regarding proper warnings to consumers. Finally, there was a belief that any direct warning would interfere with the doctor-patient relationship.  Continue reading

The Civil Rights Movement and the Blood Supply

By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Continue reading

More Than Just the ACA at Stake in King v. Burwell

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Commentators have been weighing in since the Supreme Court decided it would hear King v. Burwell, the case challenging the ability of millions of Americans to receive subsidies to purchase health insurance on federally operated Exchanges under the ACA.  Debate swirls over whether a decision striking down these subsidies will gut the ACA or not, but at the very least a ruling in favor of the petitioners would have grave consequences for ACA the and the millions that currently receive these subsidies.

There is, however, more at stake in the King case than the ACA.  If the Court takes this opportunity to cut down the ACA, it does so at the cost of the principle of separation of powers and the Supreme Court’s institutional legitimacy and credibility.

Chevron

The question in King will be resolved under the Chevron framework, which provides that if a statutory provision is ambiguous, then the court must defer to the agency’s interpretation, so long as it is permissible.  Reasonable, learned minds have been disagreeing on the meaning of the statutory provision. As Adrian Vermeule has pointed out, of the 9 federal judges that have reviewed this question, 6 have agreed with the government’s interpretation or concluded the statute is ambiguous, and 3 have concluded that the statute unambiguously precludes subsidies. This type of judicial disagreement is evidence itself of statutory ambiguity.  Continue reading