HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Friday, March 16, 2012

Religious Strings, Instrumentalism and Public Spaces

Guest blogger Kathleen Boozang has written two splendid pieces for us on Catholic (and by extension potentially other religiously affiliated) hospitals, here and here. In particular, I found Kathleen's arguments against cardboard characterizations helpful.

Catholic healthcare is too important to the country’s healthcare system to be reduced in our assessment of its value to religious proscriptions that may interfere with access to a limited universe of services, albeit what are generally considered essential healthcare services. While some may dissent from application of Catholic teaching in particular instances, the continued and pervasive presence of health providers committed to the dignity of every person whom they treat is an ultimate societal good. 

While I was ruminating on Kathleen's pragmatic, somewhat instrumental approach, I ran across a new commentary by Alta Chara in the New England Journal, here. Alta's framing is quite different, posing a fundamental question about "our public space,"

[W]hether every religious institution and adherent is free to act to the point of imposing on others, or whether every individual is free from being imposed upon to the point of stifling some who would act. 

These pieces are essential reading. [NPT]


March 16, 2012 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

Thursday, March 15, 2012

Annual Conference Announcement:The Future of Human Subjects Research Regulation

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School is pleased to announce plans for our annual conference, this year entitled: "The Future of Human Subjects Research Regulation." The one and a half day event will take place Friday, May 18 and Saturday May 19, 2012 at Harvard Law School in Cambridge, Massachusetts. 

The U.S. Department of Health and Human Services recently released an Advanced Notice of Proposed Rulemaking (ANPRM), titled "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," which proposes to substantially amend the Common Rule for the first time in twenty years. This development, as well as attention by the Presidential Commission for the Study of Bioethical Issues, suggests we are at a moment when the regulation of human subjects research is ripe for re-thinking. This conference will gather leading experts from the U.S. and across the globe to assist in that endeavor. 

We have limited space, so attendance is by permission. To apply to attend please email a paragraph explaining your interest and background to Shannon Sayer at

Click here for full conference schedule


March 15, 2012 | Permalink | Comments (0) | TrackBack (0)

Must-Read Articles on Drug Shortages

In February, Health Affairs featured Duff Wilson's article on "Deepening Drug Shortages."  As Wilson notes, "the number of reported drug shortages in the United States nearly tripled between2005 and 2010, increasing from 61 to178 and emerging as a systemic problem in the US health care system."  Sharona Hoffman has recently written on the topic: 

How could such shortages plague premier hospitals in the twenty-first century in the wealthiest country in the world? How could even patients with comprehensive health insurance and abundant financial resources be denied adequate care because the medications they require are simply not available in the marketplace?

The Article posits that public health policies and standards must serve multiple roles. They should deter both carelessness that leads to product contamination and strategic decisions to discontinue or suspend manufacturing when such decisions will cause shortages. At the same time, governmental rules should encourage production of vulnerable drugs. Accordingly, the Article proposes a blend of legislative, regulatory, and private-sector interventions that should realign manufacturers’ incentives and significantly diminish the drugshortage phenomenon.

Hoffman's article is well worth reading, and I hope it guides policymakers.  As I noted last year, a plutonomy will not reliably generate even the products that its most powerful consumers may occasionally need.

March 15, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 14, 2012

Guest Blogger Kathleen Boozang: The New York Times Hasn’t Scratched the Surface: For-Profit Catholic Healthcare

Boozang-176x220_1President Obama has begun the process for healthcare reform by improving access through insurance reform, but achievement of his aspirations will require reform of our healthcare delivery system as well.  Changing where and how healthcare is delivered and paid for is of particular importance given the emerging and generally non-acute needs of the aging baby-boomers, and the lack of sufficient primary care to serve the many who will become insured as health insurance reforms are implemented.  Healthcare providers realize this, and the market is indeed adjusting as we speak. 

Three examples of these changes to the delivery system include moving much of the delivery of services out of hospitals and into the community.  Healthcare systems are rapidly affiliating with or employing physicians to facilitate this change, in the hopes of enabling the various parts of the health care system to work more collaboratively, efficiently and cost-effectively.  In many parts of the country, hospitals have been too cash-strapped to invest in necessary up-dating to their hospital facilities. Now that we are thinking differently about how to use the physical plant that hospitals occupy, and investing in new technology, these investments need to happen.  As a third example, President Obama is infusing money into hospitals and physician offices to enable the United States to catch up to other developed nations in the digitizing of its medical records.  The benefits of this change are numerous, but it is a very expensive transformation.

In order to provide quality service and compete in the fast-changing healthcare market, hospitals and the systems of which they are a part need money to pay for these changes.  A February 21, 2012 New York Times article on the expansion of Catholic hospitals provides a glimpse of this phenomenon of market reform.  Cash-poor hospitals unable to access capital to invest in the new initiatives necessary to keep them competitive are looking for financial stronger partners with this investment ability.  There are currently 56 Catholic healthcare systems in the country, ranging from the financially successful to the distressed.  Thus it is unsurprising that a potential partner for some healthcare providers might be found among Catholic systems. 

But there are some Catholic providers who are struggling and require an affiliation to survive; other Catholic providers are simply considering alternative business models which might provide more market flexibility as well as increased options for access to capital.  The former Catholic Healthcare West is an example of the latter situation.  CHW was sponsored by six religious orders and operated 25 Catholic and 15 non-Catholic hospitals; just weeks ago, it announced changes to its name – it is now Dignity Health – and its corporate and governance structures.  The parent holding company for Dignity Health is no longer Catholic, and is no longer sponsored by the religious orders – those orders now sponsor directly the Catholic hospitals that are part of Dignity Health.  These Catholic hospitals adhere to the Ethical and Religious Directives for Catholic Health Services, of which each hospital’s local bishop is the ultimate arbiter.  The non-Catholic hospitals adhere to a Statement of Common Values, which preclude assisted suicide and euthanasia, as well as pregnancy terminations and assisted reproductive procedures that deviate from Catholic teaching; the Statement of Common Values does allow the performance of direct sterilizations.  The religious orders hope to perpetuate their evangelical influence on the culture of Dignity Health and its constituent non-Catholic hospitals, while clarifying confusion among patients about which hospitals are Catholic, and providing market flexibility with respect to future affiliations with service providers.    A statement by San Francisco Archbishop Niederauer provides a helpful description of the reasons for Catholic Health West’s transformation to Dignity Health, and the process by which deliberations occurred.

Other Catholic hospitals are engaging in even more “radical” transformations in order to put themselves in a position to survive and/or thrive in the emerging healthcare market.  After years of unsuccessful attempts to prop up the six Boston-area hospitals that comprise Caritas Christi Health Care, Cardinal Sean O'Malley surprised many when he agreed to sell the system to Cerberus Capital Management, which is a private equity firm.  The system was burdened with debt, its pension was underfunded, and its physical plant was in desperate need of significant upgrades. The sale to Cerberus transformed this Catholic health care system, now named Steward Health Care System, to a for-profit Catholic health care system.  Cerberus agreed to ensure that the Steward hospitals adhere to the Ethical and Religious Directives, subject to the authority of the Cardinal who has the power to strip a hospital of its Catholic status, as happened to a Phoenix Catholic Healthcare West hospital, St. Joseph's, in 2010, over a disagreement regarding an interpretation of the Ethical and Religious Directives regarding abortion.  

Cardinal O’Connor was not the first person to find salvation for financially distressed hospitals from the private equity world.  St. Vincent's Hospital in Worcester, Massachusetts is owned by for-profit Vanguard Health Systems of Nashville, which owns both Catholic and Baptist hospitals, primarily in the south and west. As a final example, Ascension Health, the nation's third largest health system with a 2010 net income of $1.2 billion has teamed up with Oak Hill Capital Partners to build a new for-profit enterprise with an eye towards “offer[ing] a lifeline to capital-starved Catholic hospitals.”

Myriad questions arise from this new mechanism for infusing capital into Catholic healthcare.  No precedent exists for a Catholic for-profit ministry.  In terms of the issue about access to services raised by the February 21 New York Times article, Catholic Hospitals Expand, Religious Strings Attached,  it is likely that the public will become even more confused about what rules govern hospitals as for-profit systems include both Catholic and non-Catholic entities.  While the interpretation and application of Catholic teaching will vary by diocese and by deal, it is certainly possible that, as was the case with Catholic Healthcare West, which is now Dignity Health, some or all of the Ethical and Religious Directives will be extended to the secular hospitals which are part of any system that includes Catholic facilities.  This makes sense, as Catholic teaching encourages Catholics to distance themselves from acts which are immoral.  Sometimes, the act in question, such as abortion or euthanasia is so fundamentally immoral that Catholics can have no association with the situation, which would be the case if a Catholic hospital belonged to a healthcare system in which affiliates offered these services.  As such, even though a hospital may itself be non-Catholic, if it participates in a system which includes Catholic hospitals, its services may necessarily be circumscribed.  As I discussed in my February 22, blog post, however, there are significant benefits from affiliating with a Catholic entity which should be given significant weight in assessing these arrangements.

- Guest Blogger Kathleen Boozang

March 14, 2012 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 13, 2012

Camp & Barry: Preview of the Anti-Injunction Act Issue in the Affordable Care Act Litigation

Bryan Camp (Texas Tech) & Jordan M. Barry (San Diego), Explanation of the Anti-Injunction Act Issue in HHS v. Florida (Affordable Care Act Litigation), ABA Preview of U.S. Supreme Court Cases, Vol. 39, Issue 6-SE, 2012, at 15:

This short article sorts through and reviews all the arguments surrounding the issue of whether the Anti-Injunction Act, 26 USC § 7421 (AIA), bars the federal courts from hearing constitutional challenges to the Patient Protection and Affordable Care Act (ACA). The AIA says that “no suit for the purpose of restraining the assessment or collection of any tax may be maintained in any court by any person.” If the AIA bars this lawsuit, the Supreme Court will not be able to decide whether the ACA is constitutional and the lower court opinions will be vacated. The parties to this case all want the Supreme Court to decide the ACA’s constitutionality. They all argue that the Anti-Injunction Act (AIA) does not bar this lawsuit, but for different reasons. Three amici disagree and argue that AIA bars this lawsuit, but several amici join the parties in arguing that it does not.

Hat Tip Paul Caron over at Tax Prof Blog.


March 13, 2012 | Permalink | Comments (0) | TrackBack (0)

Monday, March 12, 2012

Insurance Exchange Final Rule

HHS has published the ACA Insurance Exchange final rule, here, noting in a fact sheet here

Exchanges will offer health insurance options that meet consumer-friendly standards; facilitate consumer assistance, shopping for and enrollment in a private health insurance plan; and coordinate eligibility for premium tax credits and other affordability programs that ensure health insurance is affordable for all Americans. Through Exchanges, the public will have the same kinds of insurance choices as members of Congress.

According to the fact sheet the final rule contains standards for:

The  establishment and operation of an Exchange

Health insurance plans that participate in an Exchange

Determinations of an individual’s eligibility to enroll in Exchange health plans and in insurance affordability programs

Enrollment in health plans through Exchanges

Employer eligibility for and participation in the Small Business Health Options Program (SHOP)

As always information about a "live" exchange can be found at the Massachusetts Health Connector site, here.



March 12, 2012 | Permalink | Comments (0) | TrackBack (0)