HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, March 28, 2012

ACA Oral Argument Day 3, Pt. 2; Coercive Medicaid?

Transcript and audio files are now available, here. [NPT]

March 28, 2012 | Permalink | Comments (0) | TrackBack (0)

ACA Oral Argument Day 3

JUSTICE GINSBURG: Mr. Clement, there are so many things in this Act that are unquestionably okay. I think you would concede that reauthorizing what is the Indian Healthcare Improvement Act changes to long benefits, why make Congress redo those? I mean it's a question of whether we say everything you do is no good, now start from scratch, or to say, yes, there are many things in here that have nothing to do frankly with the affordable healthcare and there are some that we think it’s better to let Congress to decide whether it wants them in or out. So why should we say it's a choice between a wrecking operation, which is what you are requesting, or a salvage job. And the more conservative approach would be salvage rather than throwing out everything....

JUSTICE KAGAN: I mean, we have never suggested that we were going to say, look, this legislation was a brokered compromise and we are going to try to figure out exactly what would have happened in the complex parliamentary shenanigans that go on across the street and figure out whether they would have made a difference. Instead, we look at the text that's actually given us. For some people, we look only at the text. It should be easy for Justice Scalia's clerks.(Laughter.)...

JUSTICE SCALIA: I don't care whether it's clerks. I care whether it's easy for me. (Laughter.)

Transcript and audio files are now available, here. [NPT]

March 28, 2012 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 27, 2012

ACA Oral Argument

As Nic points out, Justice Kennedy asked questions indicative of someone receptive to the arguments in favor of the individual mandate. So did Justice Roberts. While both of them also challenged the Solicitor General, there still is good reason to think that the mandate could be upheld by a 6-3 vote.

The justices want some limiting principles, but there are more than enough distinguishing features of the health care insurance market to assure them that upholding the mandate will not result in a broad, federal power to force people to buy things they don't want to buy.

For my commentary on yesterday's hearings and further discussion about the mandate, see this post on CNN.

[DO]

March 27, 2012 | Permalink | Comments (0) | TrackBack (0)

ACA Oral Argument (3/27)

Justice Kennedy: That person who is sitting at home in his or her living room doing nothing is an actuarial reality that can and must be measured for health service purposes; is that their argument? … [T]hey are in the market in the sense that they are creating a risk that the market must account for.

Preliminary transcript and audio now avalilable, here. [NPT]

March 27, 2012 | Permalink | Comments (0) | TrackBack (0)

Monday, March 26, 2012

Guest Blogger Kathleen Boozang: A New Insurance Product: Responsible Corporate Officer Defense Insurance

Boozang-176x220_1Unsurprisingly, the market has responded to the new risks corporate officials in the life sciences industry face if their companies commit crimes that threaten the public’s health.  On February 7, 2012 insurance broker Marsh USA and insurer Allied Assurance Co. unveiled a new product, called RCO Corporate Response, “which provides insurance coverage for pharmaceutical, life sciences, and health care corporate officers who may be held liable for their companies’ actions under the Responsible Corporate Officer (RCO) doctrine.” 

For those who are rusty, The Responsible Corporate Officer Doctrine allows for the conviction of a high-level corporate official (ambiguity of terminology suggests that directors could be liable as well) whose company has violated the Food, Drug and Cosmetic Act irrespective of the official’s knowledge or involvement in the offense if the individual occupied a position that had a relationship with the unit that violated the statute, should have known about the activity, and had the authority to intervene. In short, the government need not produce evidence that the corporate official participated in or was aware of the illegal conduct. Potential penalties include fines, imprisonment, and debarment from the FDA.  As shall be discussed further, these penalties can lead to exclusion from Federal healthcare programs.

Continue reading

March 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Oral Argument Files

Transcript and audio files from the first day of Supreme Court arguments are available, here.

March 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Saturday, March 24, 2012

The Individual Mandate, Broccoli and Slippery Slopes

Garden-Vegetables2For two years, critics of the individual mandate have made significant headway in the battle for public opinion--and with some courts--by invoking an appealing slippery slope argument. If Congress can require people to buy a good or service solely becaue they are living in the United States, we will become vulnerable to an unlimited federal authority. Today, we must buy health care coverage, tomorrow we might have to buy vegetables or GM cars.

Not only is this a specious argument, but the slippery slope runs the other way. If the Supreme Court were to prohibit the federal government from making us buy things, then the commerce clause power would be seriously eroded.

First, the speciousness of the constitutional challenge. If the goal is to protect the public against an expansive federal power, striking down Obamacare will not in fact serve that purpose. If the Supreme Court invalidates the individual mandate, the justices will protect the public only against mandates to purchase health care insurance and a few other kinds of insurance that must be procured in advance of a voluntary economic transaction.

To be sure, a ruling against the mandate would mean that Congress could not force us to go out and buy vegetables or GM cars. But the government has other ways to make us buy those goods. Congress still would have the power to require grocery stores and restaurants to include vegetables with every sale, and it still would have the power to require service stations to sell gasoline only to owners of GM vehicles.

Now the slippery slope implications of the constitutional challenge.

Continue reading

March 24, 2012 | Permalink | Comments (0) | TrackBack (0)

Friday, March 23, 2012

Worth Reading This Week

Thursday, March 22, 2012

Symposium: “Is a For-Profit Structure a Viable Alternative for Catholic Health Care Ministry?

Next week, Seton Hall will be hosting a symposium on Catholic health care.  As noted by Health Reform Watch

On March 26-27, Seton Hall Law will be home to a two day Symposium entitled “Is a For-Profit Structure a Viable Alternative for Catholic Health Care Ministry?” Funded through the generosity of a number ofcontributors, the Symposium is being hosted by Seton Hall Law’s Center for Religiously Affiliated Nonprofit Corporations and its Center for Health & Pharmaceutical Law & Policy, in collaboration with the University of St. Thomas, John A. Ryan Institute for Catholic Social Thought, the Terrence J. Murphy Institute for Catholic Thought, Law and Public Policy and the Veritas Institute.

In an April 2010 article, a reporter for The Boston Globe pondered whether “… for-profit Catholic health care is an oxymoron, or whether profitability and religious mission can be integrated.” This Symposium will examine whether a for-profit structure is a viable alternative for Catholic health care ministry.

More details here.

[FP]

March 22, 2012 | Permalink | Comments (0) | TrackBack (0)

Monday, March 19, 2012

Guest Blogger Carl H. Coleman: New French Legislation on Human Subject Research

ColemanWhile U.S. regulators are still considering whether to follow through with last summer’s initial foray into reforming the Common Rule, changes to the human subject protection laws are already well underway in France.  Earlier this year, the French legislature enacted a new Law on Research on the Person, commonly referred to as the Loi Jardé.  The law significantly alters the regulatory landscape for French biomedical researchers, simplifying requirements in some cases while adding complexity in others. 

 

The new law, which will take effect upon publication of official decrees, divides biomedical research with human beings into three categories: 

  1. Interventional studies, defined to include studies involving interventions “not justified by the person’s usual care”
  2. Interventional studies not involving medications and involving no more than minimal risks (according to a list to be developed by the Ministry of Health)
  3. Non-interventional research, defined as studies of standard treatment that do not involve any extra or unusual diagnostic, treatment, or surveillance procedures

Research in all three categories will require the approval of a comité de protection des personnes (CPP), state-run ethics committees that are entrusted with similar responsibilities as American institutional review boards (IRB). 

For research that falls under the law’s third category—including post-marketing studies in which cohorts of patients are followed to monitor a treatment’s effectiveness and side effects—the requirement of CPP approval is new.  The requirement was added to ensure that patients who are enrolled in studies are aware that research is being carried out and are not subject to additional burdens. According to the law’s sponsors, requiring CPP approval of non-interventional research is necessary to ensure that French researchers are able to publish the results of their work in international scientific journals. 

Some studies falling into the second category of the new law may benefit from additional regulatory flexibility, including the possibility of dispensing with the use of written consent forms.  

The law will also create a national system of CPP oversight, which will take effect in the summer of 2014.  Under the new system, CPPs will be assigned on a national basis, without regard to the study’s location.

- Carl H. Coleman

March 19, 2012 | Permalink | Comments (0) | TrackBack (0)

Visiting Position in Health Law at Duquesne School of Law

Duquesne University School of Law in Pittsburgh will likely have an opening for a visiting professor to teach Health Law and related courses.  This opening will be for one, or possibly both semesters, during the 2012-2013 academic year.   We especially encourage applications from racial minorities, women, and others who would enrich the diversity of our academic community.  Interested applicants should send a résumé, along with a letter of interest, to Faculty Recruitment Committee at lawrecruitment@duq.edu.   Electronic submissions are preferred.  Candidates are strongly discouraged from submitting an application by mail.   Past teaching and scholarly experience in the field of Health Law is preferred.

[KVT]

March 19, 2012 | Permalink | Comments (0) | TrackBack (0)

Beyond Best Interests: Alternative Justifications for Regulating Reproduction

I just read two companion papers that are likely to be of interest to our readers written by Assistant Professor I. Glenn Cohen of the Harvard Law School, who is also the Co-Director of the Petrie-Flom Center for Health Law Policy. In Beyond Best Interests, 96 Minn. L. Rev. _ (forthcoming, 2012) http://ssrn.com/abstract=2014069, and Regulating Reproduction: The Problem with Best Interests, 96 Minn. L. Rev. 432 (2011) http://ssrn.com/abstract=1955292, Professor Cohen starts by pointing out that those who argue for regulating reproduction often justify it based on concern for the interests of the children who will result from the types of reproduction they would like to regulate/prevent. Professor Cohen then argues that this justification for regulating reproduction is problematic and misleading: unless the state’s failure to intervene would foist upon the child a “life not worth living,” any attempt to alter whether, when, or with whom an individual reproduces cannot be justified on the basis that harm will come to the resulting child, since but for that intervention the child would not exist. Next, he surveys a series of possible substitute justifications: non-person-affecting principles, reproductive externalities, wronging while overall benefitting, legal moralism, and virtue ethics, and shows that they too run into serious problems. At the very least, he argues, adopting one of these substitute justifications should lead us to regulate reproduction much much less than we currently do.

[KVT]

March 19, 2012 | Permalink | Comments (0) | TrackBack (0)

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 ssayer@law.harvard.edu.

Click here for full conference schedule

[KVT]

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.

[KVT] 

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.

[NPT]

 

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

Friday, March 9, 2012

Worth Reading This Week

David Orentlicher, Rights to Health Care in the US: Inherently Unstable, SSRN/AJLM

Janet Dolgin & Katherine Rouse Dieterich, The 'Other' Within: Health Care Reform, Class, and the Politics of Reproduction, SSRN/Seattle L.Rev. 

Gail Wilensky, Directions for Bipartisan Medicare Reform, NEJM

Nathan Cortez, A Medical Malpractice Model for Developing Countries? SSRN/Drexel L.Rev.

[NPT]

 

March 9, 2012 | Permalink | Comments (0) | TrackBack (0)