Bioethicist Art Caplan: UK Man, His Surrogate Mom and Their Baby Are Family

A new piece by contributor Art Caplan on NBC News:

A British high court has permitted Kyle Casson, a single man, to adopt an eight-month-old boy who was carried and delivered by a surrogate — Casson’s own mother.

To diagram this family tree, Casson, 27, technically adopted not his son but his brother because the woman who carried the baby to term is, legally, the mother. That also means that Casson’s mom gave birth, technically, to a son and a grandson at the same time.

Biologically, the child is her grandson.

The ruling traverses an array of ethical twists and turns. Let’s start with the more common fault lines. […]

Read the full article here.

Uncertainties in Cancer Screening

by Vadim Shteyler

A.F. was an elderly patient admitted to our service for a diagnostic work-up and management of a large pocket of pus surrounding her lungs. Until recently, she was very independent and in good health; this was her third hospitalization for the same reason in one month. Radiographic imaging was consistent with pneumonia but other causes could not be ruled out. She had not responded to antibiotics, she had no other signs of infection, and numerous cultures from her blood, pus, and sputum failed to grow microbes. Extensive testing for other possible causes was also negative. At that point, we all had the same suspicion—cancer. Some tumors in the chest can cause inflammation that may look like a pneumonia and result in a collection of pus. That inflammation can also hide the tumor on imaging. In fact, it would be a few weeks, after we drained all of the pus and the inflammation subsided, until we would have a clearer image of the lungs. Though cancer was a plausible explanation, we had no evidence at that time. Should we have discussed our concerns with A.F.? The diagnosis was not certain, so we didn’t…

In daily clinical practice, uncertainties come in many forms. Outcomes for most medical interventions are probabilistic (they are not 100% predictable). And those probabilities are often ambiguous (they are more often ranges than specific percentages) or simply unknown. At a broader level, science is underdetermined, medicine is inductive, and innumerable non-medical forces influence the medical landscape (biases, conflicts of interest, values, etc.).

How effectively providers communicate uncertainty is…well, uncertain. Continue reading

On Constitutional Remedies in King v. Burwell

There is one concern about the JALSA brief that I have not yet addressed because I don’t think it’s relevant: If the Court invalidates the IRS Rule and then decides the constitutional merits and holds that the condition on subsidies is unconstitutionally coercive (as I argue it might be), what will the remedy be? Will the Court invalidate the whole statute? I haven’t addressed this question because I think there is no chance that the Court will decide the constitutional merits in this case. But Randy Barnett raised the question a few days ago, and now Josh Blackman has piled on with an argument that a constitutional holding would and should nullify the whole statute. As a predictive matter, I just don’t think that’s right. Even if the Court reached the constitutional merits at some point (which I don’t think they ever will), I think they’d sever the condition.

Josh’s analysis on this point arises from one thing and one thing only: Four justices joined an opinion in NFIB (without telling us who wrote it) in which they argued against severability of the Medicaid condition. Those four justices would have invalidated the whole statute on its first trip to the Supreme Court.

Okay, sure. But what does that tell us? Continue reading

Two More Points on Federalism in King v. Burwell: A Response to Ilya Somin

And the storm rolls on… Ilya Somin has now responded to my response to him, and he correctly notes that I failed to confront his core point. (I was more focused on responding to Rick Hills and Jon Adler.) Ilya’s beef with the application of the anti-coercion argument (via the avoidance canon) in King is that he views it as nonsensical to apply anti-coercion in a way that expands federal power and limits state choice. In Ilya’s view, the plaintiffs’ interpretation in King is the one that better preserves state freedom because it allows states to pick the federal regulatory bundle that they like better. The IRS’s interpretation, by contrast, imposes a uniform regulatory bundle throughout the nation, and leaves the states free to choose only with respect to some relatively minor details of exchange implementation and management. I respond to this line of thinking at length in the JALSA brief, arguing several reasons that states’ freedom to choose under plaintiffs’ interpretation fails to mitigate the constitutional difficulties.

But in a grander sense, Ilya’s perspective is (to put it mildly) simply inconsistent with constitutional federalism doctrine (as he seems to admit). Continue reading

TOMORROW (3/11): Identified versus Statistical Lives: An Interdisciplinary Approach Book Launch

Identified_Lives_posterBook Launch: Identified versus Statistical Lives: An Interdisciplinary Approach

March 11, 2015 12:00 PM

Wasserstein Hall, Room 2012 Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Identified versus Statistical Lives: An Interdisciplinary Approach is an edited volume that grew out of the 2012 conference “Identified versus Statistical Lives: Ethics and Public Policy,” cosponsored by the Petrie-Flom Center, Edmond J. Safra Center for Ethics, and the Harvard Global Health Institute. The essays address the identified lives effect, which describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. Such bias raises practical and ethical questions that extend to almost every aspect of human life and politics.

The book talk and discussion will feature:

  • I. Glenn Cohen, co-editor, Petrie-Flom Faculty Director, Professor of Law at Harvard Law School
  • Norman Daniels, co-editor, Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Nir Eyal, co-editor, Professor of Global Health and Social Medicine (Medical Ethics), Harvard Medical School

Co-sponsored by the Harvard Law School Library, with support from the Harvard Global Health Institute.

Widespread Use of Prescription Drug Monitoring Programs to Reduce Opioid Abuse and Overdoses

It’s established that the U.S. is in the midst of a prescription opioid overdose and abuse epidemic. From 1999 to 2011, the rate of fatal prescription drug overdoses involving opioids quadrupled from 1.4 deaths/100,000 people to 5.4 deaths/100,000 people. The rate of emergency department visits attributable to prescription drug misuse (mostly involving opioids) more than doubled from 214 visits/100,000 people in 2004 to 5.4 deaths/100,000 people in 2011. Although many factors contributed to the escalation of illicit prescription painkiller use, the trend is clearly correlated with the increasing supply of opioids. A heightened focus on pain management starting in the late 1990s liberalized opioid prescribing. But in responding to the public health problem of under-treatment of pain, prescribers paradoxically have facilitated growth in prescription drug abuse. In 2012 alone, over 259 million opioid prescriptions were dispensed by retail pharmacies in the U.S. – enough prescriptions for every adult to have their own bottle of pills. Moreover, physician overprescribing has been identified as a key contributor to the opioid crisis, particularly in sourcing drugs to chronic abusers.

Prescribers, who are uniquely situated to distinguish between appropriate use and abuse of opioids and prescribe accordingly, are a natural target for regulation. Several prominent regulatory interventions recognize prescribers as opioid gatekeepers, such as the establishment of prescription drug monitoring programs (PDMPs), pain clinic laws, and mandatory opioid prescriber guidelines. Many believe that PDMPs, or state-based electronic systems that store controlled substance dispensing information and make the data available to prescribers, pharmacies, and sometimes law enforcement officials, represent a promising tool to combat opioid abuse and overdoses. And all states except Missouri have a PDMP. But prescriber awareness and use of these systems is necessary for them to have an appreciable effect. A recent Health Affairs study, Rutkow et al. used a nationally representative sample of primary care physicians and found that while 72% of physicians were aware of the their state PDMP, only 53% reported having ever used it. A number of barriers to use were identified, including the time-consuming nature of retrieving information, and the lack of intuitive format for the data provided. The authors conclude that PDMP legal mandates may increase prescriber use of the programs. Continue reading

Despite Federal Law, Some Insurance Exchange Plans Offer Unequal Coverage for Mental Health

By Kelsey Berry

One of my previous blogs discussed how potentially discriminatory practices in insurance design may continue to dissuade people with high-cost conditions from enrolling in insurance plans, even in a post-ACA world. Last week, colleagues Haiden A. Huskamp, Howard H. Goldman, Colleen L. Barry and I published new findings in Psychiatric Services on the same issue, except with a focus on an area that has historically been subject to considerable regulation: mental health benefits.

The Affordable Care Act shows considerable promise for extending mental health benefits with federal parity protections to several million Americans, which has been a main aim of mental health policy advocates for decades. However, insurers may still have an incentive on health insurance exchanges to avoid enrolling individuals who use mental health services because their care is more costly than average. In the study, we examined benefits information available to consumers shopping on state health insurance exchanges to assess whether the new insurance offerings were living up to the promise of mental health parity laws. We found that some plans may still be offering people with mental illness insurance benefits that are less generous than benefits for other medical conditions. Specifically, one-quarter of the health plans being sold on health insurance exchanges set up in two states through the ACA offer benefits that appear to violate the federal parity law requiring equal benefits for general medical and mental health care. Such benefit designs may dissuade people with mental health and substance abuse treatment needs from enrolling in the plans, furthering concerns about adverse selection and suggesting that some discriminatory practices persist despite efforts to equalize insurance offerings for individuals with behavioral health conditions. Continue reading

On Federalism and King: A Response to Critics

[This post has been edited to reflect corrections received by email from Jon Adler, whom I sincerely thank for his thoughtful engagement.]

Federalism is in the air again—once again surrounding Obamacare’s financing structure—and some people are surprisingly surprised. Given Justice Kennedy’s questions at oral argument, it’s become quite clear that King v. Burwell is about federalism, and a couple of conservative commentators have written blog posts that amount to a cry of, “I am shocked—shocked—to find federalism issues in this case.”

Of course the case is about federalism. It has always been about federalism. The only thing that the JALSA brief (which I authored)—and Kennedy’s questions arising from that brief—have added to the case is the point that constitutional federalism cuts in the government’s favor, not the plaintiffs’. Perhaps political federalism cuts in the plaintiffs’ favor—if we join Jon Adler, Michael Cannon, and Michael Carvin in their extended daydream about Senator Ben Nelson’s intent—but constitutional federalism obviously supports the IRS’s interpretation (via the canon of constitutional avoidance as well as canons urging preservation of the traditional federal-state relationship and requiring clarity in the communication of conditions). Continue reading

Replacing the Affordable Care Act?

By David Orentlicher

[cross-posted at HealthLawProfs blog]

With the future of the Affordable Care Act in doubt after last week’s hearing before the U.S. Supreme Court, Republican lawmakers are busily preparing back-up legislation. New options should not be necessary—the government should prevail against those challenging its interpretation of the Act’s premium subsidy provisions. But it is prudent to consider alternatives in the event that the Court rules against the government.

While most of the ideas being floated would do little to bring health care insurance to the uninsured, there is an option that really could expand access to coverage while also containing health care spending. And it could be attractive to Republicans and Democrats alike on Capitol Hill. Continue reading

REGISTER NOW! King v. Burwell and the Future of the Affordable Care Act

King v. Burwell and the Future of the Affordable Care Act

KIngApril 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is free and open to the public, but registration is required. Please register online.

This event is supported by the Oswald DeN. Cammann Fund.

Worth Reading This Week

By Nicolas Terry

The Scope of Virginia’s Birth–Related Neurological Injury Compensation Program

By Alex Stein

Virginia’s Birth–Related Neurological Injury Compensation Act of 1987 (BRNICA) affords aggrieved patients a no-fault compensation remedy for qualified injuries while giving potential tort defendants – doctors and hospitals who choose to participate in the Birth–Related Neurological Injury Compensation Fund – an absolute immunity from malpractice liability. Va. Code Ann. § 38.2-5002. For a parallel Florida statute, see Fla. Stat. § 766.302. Participation in this program is optional for both patients and care providers. The program compensates injured children for disability damages not covered by the government, health benefit plans, and private insurance. Pain, suffering, and other noneconomic damages are noncompensable (in Florida, they are capped at a low amount). By electing to receive treatment from a participating provider, the patient commits herself and her future child to pursue any compensation claim for birth-related neurological injury before a special administrative tribunal and automatically waives the right to bring a medical malpractice lawsuit against the participating physician or hospital. Wolfe v. Va. Birth–Related Neurological Injury Comp. Program, 580 S.E.2d 467, 476 (Va. 2003).

Because injury claims adjudicated by the tribunal do not depend upon medical malpractice, the tribunal’s decisions need not be reported to the National Practitioner Data Bank pursuant to the Health Care Quality Improvement Act of 1986. This Act, 42 U.S.C. § 11131, only requires reporting of payments “under a policy of insurance, self-insurance, or otherwise in settlement (or partial settlement) of, or in satisfaction of a judgment in, a medical malpractice action or claim.”

The scope of BRNICA’s coverage is consequently of paramount importance for patients, doctors, and hospitals. Virginia’s appellate court’s decision in Women’s Healthcare Associates, Inc. v. Mucci clarifies this scope. Continue reading

Pakistan’s “Last-Ditch Effort” To Eradicate Polio

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

In a previous post, I discussed three possible methods of increasing vaccination and decreasing vaccine refusals in the United States. One of these options was using tort law and allowing lawsuits against parents for refusing/failing to vaccinate their children. The Pakistani government has recently taken it one step further, arresting and issuing arrest warrants for parents refusing to vaccinate their children against polio. Last week,  approximately 512 people, 471 in Peshawar and 41 in Nowshera, were arrested and jailed and arrest warrants were issued for 1,200 more parents for refusing to vaccinate their children.

Currently, the government allows parents to be released from jail and return home if they sign an affidavit promising to vaccinate their children. Despite the fact there is no law requiring polio vaccination, some view the recent crackdown as “a blessing in disguise” for unvaccinated children. This drastic approach responds to high rates of refusal, a contributing factor to Pakistan’s significant number of polio cases. According to the World Health Organization, in the period since March 2014 Pakistan registered 296 polio cases, the most in the world and drastically higher than even the second-highest rate of 26 cases registered by Afghanistan. Why is Pakistan’s vaccination rate so low? For many reasons, including religious beliefs, attacks on medical workers, displacement of individuals due to ongoing military operations, and a lack of trust in health care workers and the vaccine. Continue reading

3 Reasons Not to Worry About an Avoidance Holding in King v. Burwell

Of the three constitutionally-motivated arguments that amici presented in King, the argument that Justice Kennedy picked up on (which I wrote) is the most aggressive and the riskiest from a liberal perspective. As a result, several commentators have expressed concerns about what’s coming in June. But there are 3 good reasons not to worry.

What’s the Concern?

The most alarmist worry is that the Court will take the JALSA brief‘s anti-coercion argument as a constitutional attack (rather than a statutory argument under the avoidance canon, which is what it is). The worry is that the Court will use the JALSA brief to invalidate the whole statute. Less alarmist commentators worry that an anti-coercion holding, even when issued under the avoidance canon, would set precedent they don’t like, limiting the power of the federal government to incentivize states. A non-alarmist version is that the other constitutionally-motivated arguments are sufficient bases for holding in the government’s favor, and the anti-coercion argument, at a minimum, requires the Court to venture unnecessarily into dangerous constitutional waters.

Reasons Not to Worry (if you like Obamacare) Continue reading

Which Avoidance Holding in King v. Burwell?

In Wednesday’s oral arguments, Justice Kennedy seemed highly tempted by a constitutional avoidance argument in King v. Burwell. Although Kennedy’s questions provide some optimism for the government, they have also caused some confusion and consternation. The confusion arises because three different amicus briefs presented constitutionally-motivated arguments (including one that I wrote), and it wasn’t totally clear which argument Justice Kennedy was pursuing. The consternation arises, particularly among liberal commentators, because they worry about a holding that centers on constitutional problems. The biggest concern seems to be that an avoidance holding in King would set dangerous precedent for federalism’s future.

Here, I’ll address the confusion. (In a second, I’ll address the consternation.) On the confusion: I’m entirely sure that Justice Kennedy’s questions arose from the JALSA brief rather than the other two. Here’s why. Continue reading

Academic Fellow Rachel Sachs in the SCOTUSblog, on King v. Burwell

Academic Fellow Rachel Sachs was quoted today in the SCOTUSblog:

Wednesday’s oral arguments in King v. Burwell, the challenge to the availability of tax subsidies for individuals who purchase their health insurance on a marketplace created by the federal government, continue to dominate coverage of and commentary on the Court.  In The Wall Street Journal, Louise Radnofsky and Jess Bravin report that “Justice Samuel Alito ’s suggestion that the Supreme Court could delay for months the impact of a decision to gut the health law revives the possibility that at least a dozen states could take action to limit the effect of such a ruling.”  AtFiveThirtyEight, Oliver Roeder writes that “Solicitor General Donald Verrilli won Wednesday’s oral arguments in King v. Burwell, the latest challenge to the Affordable Care Act. Or at least that’s what the wisdom of the crowd is telling us.”

[…]  At Harvard’s Bill of Health Blog, Rachel Sachs notes that “the Court displayed a more sophisticated understanding of the consequences of a decision striking down the subsidies in states that have not established their own exchanges.”

Read the full article here. See Rachel Sachs’ original post here.

Monday 3/9 HLS Health Law Workshop with Nadia Sawicki

HLS  Health Law Workshop: Nadia Sawicki

March 9, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Presentation: “Modernizing Informed Consent: Expanding the Boundaries of Materiality”

Nadia A. Sawicki is Associate Professor of Law at Loyola University Chicago School of Law. Prof. Sawicki’s research interests include the accommodation of personal and professional beliefs in a pluralistic society; the appropriate use of persuasion by state actors; the law’s recognition of legal rights to recovery for invasion of contested harms; definitions of professional roles and ethical norms in medicine; and the state’s role in enforcing those norms. She approaches these problems from the disciplines of both law and ethical theory.

MONDAY (3/9): Gender (Re)assignment: Legal, Ethical, and Conceptual Issues

genderreassignment_slideGender (Re)assignment: Legal, Ethical, and Conceptual Issues

Monday, March 9, 2015 12:00 PM

Pound Hall, Room 102, Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion.

Panelists include:

  • Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
  • Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
  • Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
  • Matthew J.B. Lawrence, Academic Fellow, Petrie-Flom Center
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School, and Faculty Director, Petrie-Flom Center

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School and Lambda at Harvard Law School.

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the March 6th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

For more on news and events at Petrie-Flom, see the full newsletter.