Month: November 2015

Changes in seasons, changes for children: Developments at the intersection of behavioral science, developmental neuroscience, and juvenile justice

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By Robert Kinscherff

It is fitting that I am writing this first blog of my time as Senior Fellow in Law and Applied Neuroscience as we transition through the change of seasons.  It is a privilege to have the time afforded by this joint Fellowship between Harvard Law School (Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics) and Massachusetts General Hospital (Center for Law, Brain, and Behavior) to focus upon the intersections of behavioral science, developmental neuroscience, and juvenile justice.  The autumnal change of seasons is a fitting metaphor for the slow but profound changes occurring in juvenile justice which have been spurred in large measure by emerging neuroscience increasingly describing the neurobiology of adolescence.  This neuroscience provides the biological complement to what developmental psychologists have well described and what parents have long known:  Children are different.

This emerging neuroscience has become a quiet but increasingly pervasive force in helping us understand why most delinquent youth desist with maturation—even adolescents who are chronically delinquent and violent.  It helps us understand why punitive “tough on teen crime” approaches born of fears in the 1990’s of the rise of violent teen “super-predators” actually compromises public safety over time—especially when youth are tried as adults and incarcerated with adults.  And, it helps us understand why mass detention and incarceration of youth—many of them for non-violent offenses—not only harms those youth but tends to increase their risks of continued misconduct and of later deep penetration into the adult criminal justice system. Read More

Actions for Sexual Assault Incidental to Medical Treatment Placed Outside the Scope of Medical Liability

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By Alex Stein

Ex parte Vanderwall, — So.3d —- 2015 WL 5725153 (Ala. 2015), is a new important decision that defined “medical malpractice” to identify suits adjudicated under special defendant-friendly rules. As I explained here, here, here, here, here, here, here, and in a foundational article on the subject, categorizing a suit as sounding in “medical malpractice”—as opposed to “ordinary negligence,” “assault” or “battery”—determines whether the plaintiff must satisfy rigid limitations and repose provisions, comply with special requirements with regard to expert testimony, face the difficult burden of proving the defendant’s deviation from professional customs, and, in the end, suffice herself with the compensation amount limited by the statutory cap on damages.

In Vanderwall, this categorization determined whether a patient could use past instances of sexual misconduct incidental to medical treatment to prove that the therapist responsible for that misconduct sexually assaulted her as well. Read More

Premiums in Medicaid: The (not so) Recent Trend

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By Emma Sandoe

Requiring Medicaid beneficiaries to pay premiums and other cost-sharing for medical services is not new to the Medicaid expansion debate. Premiums were introduced as part of the Tax Equity and Fiscal Responsibility Act of 1982. Previously, states were prohibited from imposing enrollment fees, premiums, or deductibles for any categorically eligible individual in the Medicaid program. This law allowed states to implement minimal cost-sharing for waiver demonstrations, but prohibited states from denying medical care due to an inability to pay.

Since this law was passed, the Centers for Medicare & Medicaid Services (CMS) has clarified that certain populations including pregnant women and children were exempt from most cost-sharing. Additionally, certain services are exempt from copayments and coinsurance entirely. The maximum amount that can be charged varies based on wage and type of service and where the beneficiary seeks treatment.

Prior to Indiana’s 1115, approved in 2014, CMS did not allow state waivers to charge premiums to individuals making under 50% of the federal poverty line (FPL). Indiana’s expansion plan is unlike any other state’s waiver plans. It requires individuals to pay a “monthly contribution” of $1 a month or 2% of a family’s income which ever is greater. When a beneficiary that has been paying these monthly contributions uses medical services, they are not required to pay co-payments. Previously, Indiana lowered the income eligibility for premiums during its 2013 waiver when it required premiums for individuals making between 50-100% of FPL. Arkansas and Iowa saw that precedent set by Indiana and lowered their cost sharing levels from 100% of FPL to 50%. Read More

The ACA’s Nondiscrimination Rule: Hobby Lobby 2.0?

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By Elizabeth Sepper

Should healthcare providers, researchers, and insurers be able to engage in sex discrimination for religious reasons? HHS asked the public to weigh in on this question with regard to the ACA’s nondiscrimination provision.

The answer is no for three important reasons. First, the statute doesn’t allow additional exemptions. Not only is the text clear, but Congress also considered and rejected broader religious exemptions. Second, authorizing sex discrimination for religious reasons is bad health policy with damaging effects for women and LGBT people. Third (as I argued in separate comments with a group of law and religion scholars), granting religious exemptions here runs into constitutional limits set by the Establishment Clause.

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The ACA’s Nondiscrimination Rule: Puzzling Misreading of the Statute

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By Elizabeth Sepper

Like other healthcare civil rights statutes, the Affordable Care Act’s Section 1557 links nondiscrimination requirements to federal funding. Programs that receive “federal financial assistance” can’t discriminate against individuals based on their race, sex, age or disability. HHS has proposed to exclude Medicare Part B payments from “federal financial assistance.” As a result, physicians’ offices would be outside Section 1557’s reach. The statute, however, bars this puzzling and contradictory interpretation.

For almost fifty years, HHS has taken the position that Medicare Part B payments to physicians are “contracts of insurance.” Because previous civil rights statutes—like Title VI of the Civil Rights Act and the Rehabilitation Act—explicitly excluded “contracts of insurance” from the definition of “federal financial assistance,” physicians were exempted from compliance. Payments under Medicare Part B and other insurance contracts did not suffice to create nondiscrimination obligations.

HHS’s interpretation of Section 1557 would again exclude Medicare Part B payments from the ambit of “federal financial assistance.” But, this time, the statute doesn’t allow it. Section 1557 specifically states that federal financial assistance includes “contracts of insurance.” HHS can’t have it both ways, defining Part B as “contracts of insurance” when the statute excludes them and defining Part B as something else (it’s not clear what) when the statute includes contracts of insurance. The only permissible interpretation of Section 1557 means providers who participate in Medicare can’t discriminate.

In a series of posts this week, we’re blogging on the proposed HHS Nondiscrimination Rule. You’ll find our first post here. Look for our next posts on religious exemptions and remedies under Section 1557 later this week.

The Common Rule NPRM: Biospecimens

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By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”).  The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011.  The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues.  We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.

In this installment, we discuss the NPRM’s proposed changes to biospecimens research.  The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research.  However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research.  That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem.

ACRG Rapid Rundown:  Six Things You Need to Know Read More

The ACA’s Nondiscrimination Rule: Kudos and Critiques

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By Elizabeth Sepper

More than five years ago, Section 1557—a little known provision in the Affordable Care Act—promised to protect individuals from race, sex, age, and disability discrimination in health programs and activities that receive federal financial assistance. But until this fall, the Department of Health and Human Services (HHS) hadn’t offered any interpretation of what the nondiscrimination provision requires. Today, the comment period for the proposed rule closes, and HHS will set to work finalizing the Nondiscrimination Rule. Together with professors Jessica Roberts and Jessica Clarke and Yale Law students Elizabeth Dervan and Elizabeth Deutsch, I drafted lengthy comments on the proposed rule.  In a series of blog posts this week, we’ll explain what HHS got right, where its interpretation went wrong, and how it can provide clarity to healthcare programs and the public.

The ACA broke new ground in prohibiting sex discrimination in healthcare for the first time. Women and LGBT people face persistent and systemic discrimination at the hands of insurers, hospitals, and doctors. Women’s pain goes undertreated, and their heart attacks undiagnosed. Due in part to their capacity to become pregnant, women have largely been excluded from studies. More than half of LGBT people report facing discrimination in healthcare settings. Transgender men and women have encountered ridicule, refusals of treatment, and hostility in emergencies with fatal and near-fatal consequences.

The Affordable Care Act aims to change this. The Nondiscrimination Rule presents a historic opportunity for HHS to interpret sex discrimination broadly. In its proposed rule, HHS seems poised to take advantage of this opportunity by reaching pregnancy, sex stereotyping, and gender identity discrimination. To meet HHS’s goal of ensuring the most robust set of protections in current law, the final rule should also make clear that sexual orientation discrimination is sex discrimination.

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Nevada’s $350,000 Cap on Noneconomic Damages Held Constitutional and Applicable Per Incident

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By Alex Stein

Bad news for Nevada’s victims of medical malpractice. This state’s Supreme Court upheld the constitutionality of the $350,000 cap on noneconomic damages as limiting recovery for all kinds of victims and injuries. Tam v. Eighth Jud. Dist. Ct., — P.3d —- , 2015 WL 5771245 (Nev. 2015).  Moreover, the Court held that the cap applies per incident, which encompasses all mistakes that the doctor may have made in delivering a single treatment to a patient and all the victims of those mistakes (such as twins born with birth defects as a result of negligent prenatal care or delivery). For my discussion of the “per incident” and alternative approaches to caps, see here. Read More

Lecture Tomorrow, 11/10! Euthanasia in Belgium: The most recent legal developments and policy challenges

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Euthanasia in Belgium: The most recent legal developments and policy challenges
November 10, 2015 11:00 AM – 12:15 PM

Conference Room, 1st floor
Center for Bioethics at Harvard Medical School
641 Huntington Ave., Boston, MA [Map]

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghent University, Belgium; End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Bioethics Institute Ghent, Ghent University, Belgium.

In 2002, euthanasia by a physician (the intentional termination of a patient’s life at his or her request) was depenalized in Belgium for adults and emancipated minors. In 2014, the law was extended to competent minors, without an age limit. The frequency of performance of euthanasia is rising very rapidly, having more than doubled in the last five years (accounting for one death in twenty, about 8 per day in Flanders, the Dutch-speaking region). Moreover, although the prevalence of euthanasia remains highest in patients with cancer, a clear shift is visible in the characteristics of patients who request euthanasia and whose requests are granted. The largest increases are among women, and those aged 80 or older, with lower education levels, and those dying in nursing homes. Read More

‘The Week in Health Law’ Podcast

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By Nicolas Terry

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This week we are joined by Glenn Cohen, Professor of Law at Harvard Law School and Faculty Director of Harvard’s Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, and Holly Fernandez Lynch, Executive Director of the PFC and member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), at the U.S. Department of Health and Human Services.

We discussed the NPRM on the Common Rule, summarized here and here. (Comments are due by December 7th.) Holly and Glenn offered perspectives on the nature and purpose of the proposed revision, and the bioethical aims it served, with a particular focus on the advancement of research. Frank focused on the practical implications for designing consent procedures for learning health care systems. Nic commented on the regulatory complexity arising out of the interaction of HIPAA and HSR protections of data. Podcast listeners will find themes in this episode also engaged in our conversations with Deirdre Madden and Michelle Meyer.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw