Sex Markers in Official Documentation – Between Biology and Self-Identification

A recent civil action filed by LAMBDA Legal highlights a debate ongoing for the past several years on the issue of “sex-markers” in official documentation to the U.S courts. In different instances, plaintiffs and interest groups have sought to challenge the state’s sex-binary classification system when issuing official identification documents such as passports, birth certificates, driver’s licenses and more. Litigation and advocacy around sex-markers in official documentation may be roughly distinguished between groups advocating for easier access to the existing Male /Female categories (“M/F”), mostly by and for the trans community, and to groups asking to break the M/F distinction altogether in favor of an unspecified category: ”X”/”MF”/Unknown/Unspecified. This group is not seeking better access to the existing M/F categories, but is rather pursuing the goal of creating an all-inclusive new category for those who do not identify as males or females, sometimes also referred to as “third sex” or “third gender”.

These challenges were sometimes fruitful in generating administrative adjustments. For example, in 2011 it became possible to mark “X” instead of M/F on passports in Australia. In 2013 Germany approved a change in legislation that allows leaving the “sex” checkbox in birth certificates empty. These developments were presented very positively in the media with headlines like: “Germany got it right by offering a third gender option on birth certificates” in the Guardian, or: “Germany allows ‘indeterminate’ gender at birth” in the BBC, that portrayed them as victories for intersex and LGBT activists. Although the wish to open up sex categories in official documentation seems to be in line with progressive politics, some Intersex advocacy organizations have had misgivings about this line of advocacy. One argument is that being an Intersex or a Trans person does not necessarily dictate a non-specified gender identity and so conjoining intersexuality and transgenderism with non-specified gender identity is incorrect to say the least.

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NPRM Symposium: Consent and Consistency in the NPRM

By Luke Gelinas, Guest Blogger

  1.  Interpreting the proposed consent requirement

One of the most discussed and controversial aspects of the Department of Health and Human Services’ recent notice of proposed rule-making (NPRM), which stands to change the federal regulations governing research with human beings, is a new consent requirement for secondary research on bio-specimens.  ‘Secondary research’ involves leftover blood or tissue samples that are re-purposed for research after their original use as clinical samples or in prior research studies has been served.  Whereas the current regulations permit re-purposed samples to be used in research without consent so long as the samples are anonymized or de-identified, the new rule would require individuals to be notified that their samples will be used in research, and to give broad permission or consent for such use, before research using them is permitted.

One possible justification for the new consent requirement is what I will call the ‘rights-violation’ interpretation.  The rights-violation approach maintains that consent for research with biospecimens is ethically required to avoid a rights-violation—which is what, the view claims, using someone’s samples without their consent amounts to.

Defenders of this view face the challenge of saying precisely which right is violated by research with re-purposed specimens.  One idea is that the samples still count as part of the individual’s body, even if they are no longer spatially continuous with it, so that using them without consent infringes a bodily right.  A second possibility is that, even if donated specimens are not part of one’s body in the relevant sense, we yet have ownership interests in and claims to our biological materials, so that  something closer to a property right at stake.  A third view focuses on the personal health information that can be garnered from certain sorts of research with bio-specimens (e.g., research involving whole genome sequencing), claiming that privacy rights stand to be infringed when specimens are used without consent.  Each of these views raises complex ethical (and indeed in some cases metaphysical) issues that defenders of the rights-violation interpretation must work out.  Read More

The Zubik v. Burwell Oral Argument

Photo: Zubik v. Burwell Signs
Tim Ritz / Americans United for Separation of Church and State

By Gregory M. Lipper

Over at Rewire, I’ve analyzed yesterday’s oral argument in Zubik v. Burwell. Among other things, I address the recurring claim that the government was “hijacking” religious objectors’ health plans by arranging for third party insurers and plan administrators to provide contraceptive coverage to affected women:

The fear of hijacking might have made sense if we were talking about a plane instead of a plan. But an insurance company is not an employer’s personal property. If the insurance company, separately from the employer, wants to provide extra coverage to the employees, that’s none of the employer’s business—especially since that contraceptive coverage is guaranteed to women by federal law. At the argument, Clement compared the accommodation to the government running a contraception clinic out of the Little Sisters’ home, but the more apt analogy is that the government has set up shop across the street: The challengers simply have no legitimate interest in preventing the government from “hijacking” a nearby vacant lot.

You can read the full article at Rewire’s freshly redesigned website. And more on the “hijacking” argument here.

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with prolific health law scholar Mark Hall, Director of the Health Law and Policy Program and Fred D. & Elizabeth L. Turnage Professor of Law at Wake Forest University School of Law.

Our discussion started with Medicaid expansion and a fascinating paper, Medicaid Expansion Costs in North Carolina: A Frank Discussion (with Edwin Shoaf) that takes a rigorous cost-benefit approach to the topic. Next up we discussed the potential for employer private exchanges and some of their legal implications. Finally, we looked back on Mark’s 2014 frank assessment of the ACA. Check out Mark’s SSRN page for more of his contributions to the health law and policy literature.

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 RadioTunein 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

PANEL (4/5): The National Security Implications of the Genetics Revolution

 

Technology Concept

The National Security Implications of the Genetics Revolution
April 5, 2016 12:00 PM
Pound Hall, Room 101
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

 

Panelists:

  • Jamie Metzl, JD ’97, Senior Fellow for Technology and National Security of the Atlantic Council. He has served on the U.S. National Security Council, State Department, and Senate Foreign Relations Committee, as Executive Vice President of the Asia Society and with the United Nations in Cambodia. A globally syndicated columnist and regular guest on national and international media, he is the author of a history of the Cambodian genocide and the novels The Depths of the Sea and Genesis Code.

Topic: The National Security Implications of the Genetics Revolution

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

Topic: Post-9/11 Uses of Public Health and Medicine by National Security Agencies 

  • Jonathan D. Moreno, PhD, David and Lyn Silfen University Professor of Ethics, Perelman School of Medicine, University of Pennsylvania

Topic: National Security and Biology

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

Cosponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Harvard National Security & Law Association, the Harvard National Security Journal, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Tax exemptions and nonprofit hospitals: An uncertain future

Of the 4,926 community hospitals in the United States, the majority, about 58 percent (2,870) are not-for-profit. About 21 percent (1,053) are for-profit, and the remainder are owned by state and local governments. Hospitals serve communities by caring for the sick, but they’re also often billion dollar enterprises and tension between the mission and business model of nonprofit hospitals is growing.

Nonprofit hospitals are expected to benefit their community in exchange for their tax-exempt status. Hospitals have most commonly fulfilled this obligation by providing uncompensated care, or charity care. However, this has historically been poorly regulated. A 2013 study found that on average nonprofit hospitals spent 7.5 percent of their operating expenses on community benefit activities, and 85 percent of that was charity care. However, there was major variation in the amount allocated to community benefit, ranging from 1 percent to 20 percent.

The Affordable Care Act introduced new community benefit reporting requirements for nonprofit hospitals in an effort to bring more clarity and accountability to the amount and quality of “community benefits” delivered in exchange for 501(c)3 tax exemption. The value of the nonprofit tax exemptions for hospitals is significant: it was estimated at almost $25 billion in 2011. For states and municipalities in particular, the foregone tax revenue is nontrivial, especially as their taxes bases were squeezed by the burst of the housing bubble in 2008. It should be little surprise, then, that municipalities have started to scrutinize the tax exemptions for nonprofit hospitals.

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Zubik v. Burwell, Part 6: The Accommodation is the Least-Restrictive Option

Photo: Demonstration
Flickr/Creative Commons—Joe Brusky

By Gregory M. Lipper

(Read Part 1, Part 2, Part 3, Part 4, and Part 5 of this series)

The plaintiffs in Zubik v. Burwell and its siblings seek to block their students and employees from receiving contraceptive coverage from third-party insurance companies and plan administrators. Even though the plaintiffs need neither provide nor pay for contraceptive coverage, they argue that the government can and must adopt one or more purportedly less-restrictive alternatives, including (1) providing contraceptives or contraceptive-specific coverage to women directly; (2) offering grants to other entities that provide contraceptives; (3) offering tax credits or tax deductions to women required to pay for contraceptives; or (4) expanding eligibility for programs that provide contraceptives to low-income women. (The University of Notre Dame, whose petition for Supreme Court review is pending, has also argued that it could provide coverage for natural family planning; the Seventh Circuit correctly noted that natural family planning “is not contraception at all.”)

These proposed alternatives would not achieve the government’s interest as effectively as the accommodation; they would, instead, impose financial or logistical barriers on women, thwarting their seamless access to contraceptives and demoting contraceptives to junior-varsity care. Women would be forced to identify and register for yet another new program, perhaps see a different doctor for contraception-related care, and possibly pay out of pocket. (For more on the problems with the proposed alternatives, see my organization’s brief on behalf of 240 students, faculty, and staff at religiously affiliated universities, as well as the brief of health law policy experts prepared by Hogan Lovells.)

By requiring women to jump through logistical hoops and incur additonal costs, the proposed alternatives would reduce access to and use of contraceptives. Studies show that even minor barriers can dramatically reduce contraceptive access: Read More

Zubik v. Burwell, Part 5: These Exceptions are Unexceptional

Photo: Bronze IUD
Flickr/Creative Commons—Sarah Mirk

By Gregory M. Lipper

(Read Part 1, Part 2, Part 3Part 4, and Part 6 of this series)

Despite birth control’s considerable benefits, the challengers in Zubik v. Burwell argue that the government lacks a compelling interest in applying the contraceptive accommodation to religious objectors. No matter how important it is to ensure that women have access to contraceptive coverage, the challengers say, the presence of other exceptions to the coverage requirements makes the interest in providing contraceptive coverage less than compelling. If contraceptive coverage were truly important, the argument goes, then there wouldn’t be any exceptions at all.

This argument proves too much—way too much. Almost all laws have exceptions. As the government explains in its brief to the Supreme Court, “Numerous organizations are not required to pay taxes; half the country’s draft-age population is exempt from registering for the draft; and Title VII does not apply to millions of employers with fewer than 15 employees, see 42 U.S.C. 2000e(b). Yet no one would suggest that raising tax revenue, raising an army, and combating employment discrimination are not compelling interests.” Indeed, despite Title VII’s exemption for small employers, the Supreme Court in Hobby Lobby reiterated that “[t]he Government has a compelling interest in providing an equal opportunity to participate in the workforce without regard to race…”

Despite these examples, the plaintiffs claim that the government’s interest in contraceptive coverage is undermined by three exceptions: (1) employers with fewer than fifty employees need not provide health insurance at all; (2) houses of worship are exempted from the contraceptive-coverage requirement; and (3) grandfathered employers are exempted from some coverage requirements, including the one pertaining to contraceptives. But none of these make the government’s interest any less compelling.

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