Category: Holly Fernandez Lynch

New Paper on Conscience and the ACA

Holly Fernandez Lynch Leave a comment

Piggy-backing on Glenn’s post below, I just wanted to point you to my contribution to the same symposium issue of Ethical Perspectives.  The paper, “Religious Liberty, Conscience, and the Affordable Care Act,” can be downloaded here, and copied below is the abstract:

Broadly applicable legal requirements often come into conflict with moral or religious standards that individuals and organizations feel more strongly compelled to obey. Making room for such moral and religious standards in secular society is important, but can be difficult, since any exemptions or accommodations cannot be allowed frustrate the purpose of the general law, and must also be fair to those who remain subject to it without any special arrangements.

This essay briefly surveys the ways in which the Affordable Care Act might come into conflict with moral and religious beliefs held by both individuals and institutions, and describes the government accommodations that have been offered or considered to date. In particular, it focuses on the requirement that employers offer insurance coverage for free contraceptives and the requirement that individuals purchase insurance coverage that may include services they find objectionable. In both cases, I conclude that the proffered accommodations should be altered to enhance fairness as between objectors and non-objectors.

Health Law Year in P/Review Video

The Petrie-Flom Center Staff Leave a comment

If you couldn’t make it to our inaugural session on Health Law Year in P/Review, co-hosted by the Petrie-Flom Center and the New England Journal of Medicine, you’re in luck!  You can watch the video here:

https://www.law.harvard.edu/media/2013/02/01_pf.mov

Topics and speakers included:

The ACA and Health Care Reform

Contraceptives Coverage and Personhood Amendments

Immigrants’ Access to Health Care

Affirmative Action and Medical School Admissions

Gene Patenting

Tobacco and Obesity Policy and the First Amendment

Summary and Wrap Up

Closing Remarks from Dean Martha Minow

More on Contraceptives Coverage

Holly Fernandez Lynch Leave a comment

For an excellent perspective on the legal challenges to the contraceptives coverage mandate being brought by for-profit, secular companies with religious owners, check out Bill Keller’s recent NYT op-ed.  A brief snippet:

“Also, courts tend to distinguish between laws that make you do something and laws that merely require a financial payment. In the days of the draft, conscientious objectors were exempted from conscription. A sincere pacifist could not be obliged to kill. But a pacifist is not excused from paying taxes just because he or she objects to the money being spent on war. Doctors who find abortions morally abhorrent are not obliged to perform them. But you cannot withhold taxes because some of the money goes to Medicaid-financed abortion.”

These analogies are helpful, but I’m not sure I’m totally convinced that the employers here are only being asked to make a financial payment equivalent to a tax.  Certainly they don’t have to take contraceptives themselves, but they aren’t being asked to just pay money to the government – they are being asked to directly arrange coverage for something they find morally objectionable.  So I’m really on the fence here.

Ultimately, I don’t want to be too quick to dismiss the complicity objections raised by these employers as just the same as tax objections that are easily waived off as completely unworkable.  We can’t have every Tom, Dick, and Harry refusing to pay taxes for things they find objectionable – but we could come up with a system for accommodating the religious objections of secular business owners: namely the accommodation being offered to religious employers.  If insurers can bear the burden of handling contraceptives coverage completely on their own for religious employers like hospitals and universities, why couldn’t they do the same across the board?

And let me reiterate once again that all of this just demonstrates that employers really have no place whatsoever in our healthcare system.

India Releases New Rules on Clinical Trial Injury

Holly Fernandez Lynch Leave a comment

Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.”  You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:

  • “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.”  Note that this doesn’t say anything about the injury being study-related.
  • If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
  • If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
  • Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence.  But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”.  Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
Like all of the presidential bioethics commissions and many others that have considered this issue, I’m all for the adoption of reasonable and appropriate compensation systems to make subjects whole in the event of study-related injury.  And I think US policy is woefully inadequate on this score.  But the pendulum can also swing too far in the other direction.  Will sponsors take their trials elsewhere or will research in India still be worth it?
[H/T to Rebecca Li for the head’s up re: publication of the new rules.]

Breaking News on Contraceptive Coverage Mandate

Holly Fernandez Lynch 1 Comment

News Release

FOR IMMEDIATE RELEASE
February 1, 2013		 Contact: HHS Press Office
(202) 690-6343

Administration issues Notice of Proposed Rulemaking on recommended preventive services policy

The Obama administration today issued proposed rules for public comment regarding contraceptive coverage with no cost sharing under the health care law. The proposed rules provide women with coverage for preventive care that includes contraceptive services with no co-pays, while also respecting the concerns of some religious organizations.

Today’s Notice of Proposed Rulemaking reflects public feedback received through the Advance Notice of Proposed Rulemaking issued in March 2012.  In addition, these proposed rules are open for public comment through April 8, 2013.

“Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,” said Health and Human Services Secretary Kathleen Sebelius.  “We will continue to work with faith-based organizations, women’s organizations, insurers and others to achieve these goals.”

The proposed rules lay out how non-profit religious organizations, such as non-profit religious hospitals or institutions of higher education, that object to contraception on religious grounds can receive an accommodation that provides their enrollees separate contraceptive coverage, and with no co-pays, but at no cost to the religious organization.

With respect to insured plans, including student health plans, these religious organizations would provide notice to their insurer.  The insurer would then notify enrollees that it is providing them with no-cost contraceptive coverage through separate individual health insurance policies.

With respect to self-insured plans, as well as student health plans, these religious organizations would provide notice to their third party administrator.  In turn, the third party administrator would work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies.

Insurers and third party administrators would work to ensure a seamless enrollment process. The proposed rules lay out how the costs of both the insurer and the third party administrator would be covered, without any charge to either the religious organization or the enrollees.

Additionally, the proposed rules simplify and clarify the definition of “religious employer” for purposes of the exemption from the contraceptive coverage requirement.  These employers, primarily houses of worship, can exclude contraception coverage from their health plans for their employees.

The proposed rules are available here: https://www.ofr.gov/inspection.aspx

A fact sheet on today’s proposed rules is available here:
https://cciio.cms.gov/resources/factsheets/womens-preven-02012013.html

For more information on women’s preventive services and the Affordable Care Act, visit: https://www.healthcare.gov/news/factsheets/2011/08/womensprevention08012011a.html

Thank You, Bill of Health Readers!

The Petrie-Flom Center Staff Leave a comment

Happy Thanksgiving!  Today, we just wanted to give a big thank you to our loyal readers, dedicated bloggers, and excellent commenters.  You’ve helped make Bill of Health a tremendous success in just a few short months, and we look forward to continuing to bring you excellent commentary and analysis on all things related to health law policy, biotechnology, and bioethics.

Enjoy the day with family and friends!

Best wishes and thanks from the Bill of Health Editors.

Another Contraceptives Mandate Case

Holly Fernandez Lynch Leave a comment

Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate.  This one is from Nov. 19 and involves the owners of Hobby Lobby.  The court denied their motion for a preliminary injunction on the following grounds:

Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.

Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.

There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds.  But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien).  Have I missed any?

Study Guide on the Guatemala STD Inoculation Studies

Holly Fernandez Lynch 1 Comment

Talk about perfect timing.  Just on the heels of Tuesday’s fantastic event at HLS on the Guatemala STD Inoculation studies (video to come soon), the Presidential Commission for the Study of Bioethical Issues has released A Study Guide for “Ethically Impossible” STD Research in Guatemala from 1946 to 1948.  This is the Commission’s first foray into pedagogy, and an absolutely fantastic way to keep the discussion going.  Be sure to check it out, and to share widely.

Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?

kparas Leave a comment

TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

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