HealthLawProf Blog

Published This Week

Giulia Funghi, Alessandro Rosanò, Shadow Lines and Scapegoats: Medical Criminal Liability in Italy in the Framework of National and International Medical Guidelines, 3 ELSA Malta L. Rev. 14 (2013).

Rodica Plugaru, The Role of International Actors in Post-Communist Countries: Coercion or Persuasion? The Transfer of Hospital Design Standards by International Organizations and Private Firms, SSRN.

[KVT]

Call for Applications for the Kermit Gitenstein Distinguished Visiting Chair in Health Law and Policy

Touro College Jacob D. Fuchsberg Law Center invites applications from experienced health law teachers and scholars for the Kermit Gitenstein Distinguished Visiting Chair in Health Law and Policy. Touro is seeking a nationally-known professor in the field of health law and policy to fill the chair for the spring semester in 2015. The Gitenstein visiting professor will teach at least one course at the law school, deliver public lectures, and participate fully in faculty and student life.

Touro Law Center is part of Touro College, which includes New York Medical College—one of the largest private health sciences universities in the nation. The visiting chair will have the opportunity to develop collaborative initiatives with the medical profession in general and New York Medical College in particular. Women, members of minority groups and others whose background will contribute to the diversity of the faculty are encouraged to apply.

Touro Law Center is a dynamic institution that is at the forefront of legal education in this country, dedicated to producing practice-ready graduates. Touro’s students have the unique opportunity to take advantage of the first-ever law campus in the United States—a law school adjacent to and working with both a federal courthouse and a state courthouse. The law school is located in Suffolk County, Long Island, approximately an hour outside of New York City.

Interested candidates should send a cover letter and resume at the earliest possible date for full consideration. Contact: Samuel Levine, Appointments Committee Chair and Director of the Jewish Law Institute, at [email protected].

Touro College is committed to the principles of equal employment opportunity. Our practices and employment decisions regarding employment, hiring, assignment, promotion, compensation, and other terms and conditions of employment are not to be based on an employee's race, color, sex, age, religion, national origin, disability, ancestry, military discharge status, sexual orientation, marital status, genetic predisposition, housing status, or any other protected status, in accordance with applicable law. Our policies are in conformance with Title IX, 1972 Education Amendments.

[KVT]

Guest Blogger Professor Wilson R. Huhn – Action of Ohio Controlling Board on Medicaid Expansion

According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:

On Monday, October 22, at the urging of Governor Kasich, the Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5 billion in federal funding to expand Medicaid in the State of Ohio. Under the laws of Ohio this action was valid.

The Controlling Board is a state agency created by statute. The agency has two principal powers: it can transfer funds and authorize purchases by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code states: “Controlling board authorization for a state agency to make an expenditure of federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”

Two advocacy organizations (the Buckeye Institute and the 1851 Center for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the Controlling Board. They contend that the action of the Board violates Section 127.17 of the Ohio Revised Code, which provides that the Board is bound by the intent of the Ohio General Assembly. The challengers quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich vetoed this bill, but the challengers argue that despite the Governor’s veto it’s clear that the General Assembly did not want the Controlling Board to accept federal funding to expand Medicaid.

Section 5163.03 of the Ohio Revised Code authorizes the state’s Medicaid program to cover any “optional Medicaid group” unless state statutes expressly prohibit such coverage. If state statutes are silent, this law says that the state is permitted to expand Medicaid to that group. Section 5163.03 is the prevailing law – the vetoed bill that would have prohibited Medicaid expansion is not.

The action of the Governor and the Controlling Board was authorized by statute and was not prohibited by the legislature. If the legislature wishes to prevent Medicaid expansion then it must pass a law prohibiting this action over the veto of the Governor.

To listen to a debate on Ideastream between Professor Huhn and one of the the plaintiffs in the lawsuit, go here.

Wilson R. Huhn is a Professor at the University of Akron School of Law and the author of the book ObamaCare: Is It Necessary, What Will It Accomplish, Is It Constitutional? and The Five Types of Legal Argument.

[KVT]

Hobby Lobby Keeps Moving Forward

For those following the so-called contraceptive mandate litigation, additional documents were filed today with the Supreme Court, but this time the Solicitor General suggested that the petitions in Conestoga Wood be held (here), while the Court considers the petitions in Hobby Lobby.  The Solicitor General's prior petition for cert., in addition to this request, make it appear all the more likely that the Hobby Lobby case will move forward.

Published This Week

Dorit Rubinstein Reiss, Compensating the Victims of Failure to Vaccinate: What are the Options?, 23 CORNELL J. OF L. & PUB. POL'Y __ (2014).

Thaddeus Pope, Judicial Responsibility to Decide Bioethics Cases, 10 J. OF BIOETHICAL INQUIRY (FORTHCOMING 2013).

 

[KVT]

Kludgeocracy in America

The PPACA rollout has been termed a disaster (at least on the federal level). What went wrong? Both firms and governments find big software projects hard to manage. The federal procurement process is a mess. But perhaps the biggest problem is the level of complexity that American politics & law imposed on the project.
As Garance Franke-Ruta observes:

Obamacare was damaged at the outset by the political tug-of-war over its very existence, and the conflicts at its creation have had serious downstream effects, placing the federal government in charge of far more than it was supposed to be doing. It also has also suffered from what Johns Hopkins University political scientist Steven Teles calls “kludgeocracy”—the tendency of interest groups, lobbyists, bureaucracy, and bad management to combine to create highly complex legislation and giant public-administration kludges, a term defined as “an ill-assorted collection of poorly-matching parts, forming a distressing whole.”

That is what Obamacare is proving to be, though it has its bright spots, too among the 14 state exchanges. The law passed in March 2010, but final rules governing how the exchanges were to work were not issued until March 2013. A bid from the main IT contractor, CGI Federal, was accepted in September 2011, but the company did not start critical work until this spring because it was waiting for specifications from the government, leaving too little time to troubleshoot the enormously complex systems CGI and others were setting up.

It’s hard to believe that the whiz kids behind NSA data gathering and analysis couldn’t have done some good here. HealthCare.Gov cost less than 1% of spy agencies’ budgets. But to suggest health IT should command even a fraction of the resources of the intelligence apparatus is a heresy in Schmayek's Town.

Resources for Learning About (and Tracking) Violations of Research Law and Ethics

Even health law professors who do not teach a class in research law may be asked to participate in their university's programs for training researchers.  Now that the government is back in business, this seemed like a good time to feature some resources to help bring you up to speed.  The information below focuses on some of the main Federal Government sources of not just information but very high quality educational material.  All of this information is accurate as of today--but any web resource can suffer from link rot, and a direct Google search should lead you to all of these sources and more.

The most general place to start is actually not in the Federal Government, but rather CITI on-line training resources.  Although today their website says that these materials are no longer available to the public for free, it is likely that anyone associated with an institution that conducts federally funded research is a subscriber.   The unavailability of CITI to the public is unfortunate, but the amount of training provided for free by the federal government is beyond the scope of any individual human's ability to absorb information--everything from this point on is free!

 The Federal Government's regulation of research misconduct, research integrity and protection of human and animal subjects of research (yes, all of these things are different) is scattered not just among the various entities sponsoring research, but also within agencies.  While all have adopted "The Common Rule" when it comes to humans, in fact there can be significant differences in policies and regulations (especially in situations not involving humans).  Here are some places to start looking. 

   The location of this information depends both on the kind of research and the source of funding.   For research funded by the department of health and human services (biomedical research primarily) the relevant agency is the Office for Research Integrity (ORI) which " oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration" and this is the website that tracks cases they are and have investigated.

Here's a movie they produced on avoiding research misconduct.  It's available with  Spanish and  Chinese subtitles

If the research safety violations involves people, you need to go to the entity within HHS currently known as the Office for Human Research Protections (OHRP)(remembering the "s" at the end of "Protections" shows you to be an insider).  This is a vast repository of both reference material and current reports of active cases--you might want to look at this overview first.

If you are getting funding directly from the National Institutes of Health, you will want to check in with Human Subject Research Protections (HSRP) program (note the "s") and their rules and guidance.  More information to be found here.

NIH also sponsors its own Human Subject Research Protection Online Training.  Also available in Spanish.

Research under the supervision, although not necessarily funding, of the FDA is monitored its Bioresearch Monitoring (BIMO) program is a comprehensive program of
on-site inspections and data audits designed to monitor all aspects of the
conduct and reporting of FDA regulated research.   This is not to be confused with the FDA's Office of Criminal Investigations which has a broader scope and covers not just research but all FDA monitored activities.

Actually,  "all" is an understatment because Recalls, Market Withdrawals and Safety Alerts are tracked elsewhere and there may be some spillover. Ditto MedWatch: The FDA Safety Information and Adverse Event Reporting Program.  If the violations directly concern human safety you should check here and in general at the Center for Drug Evaluation and Research

 

The National Science Foundation (NSF) is another major source of information.  The research it sponsors differs from that sponsored by NIH because it extends far beyond biomedical activities.  Indeed, NSF is the place to look for information about social science or behavioral research.

Here's where to look for  human subjects.  For more general wrongdoing, consult the NSF Office of the Inspector General.

The National Academy of Engineering has devoted considerable resources to issues of research ethics, misconduct and integrity which are available in its online Ethics Center.  Texas Tech University also provides extensive resources in Engineering Ethics through the Murdough Center.

The Institute of Medicine is often asked by Congress to investigate issues in Biomedical and Health Research.

The Department of Energy is a major player in the field of research ethics/human subject protection (it does considerable nuclear and genetics research) and has many resources.

It's very hard to distinguish between "bioethical" issues and "legal" issues when it comes to research, so another very important source of information is the Presidenial Commission for the Study of Bioethics.  which recently put out a remarkable report on Human Subject Research Violations which took place during the 1940's in Guatemala. (spoiler, the U.S. Public Health Service was giving people syphillis).

In future posts, I will dig deeper and provide more governmental and private sector resources.

Dartmouth Institute Publishes Atlas of Medicare Part D Areal Variations

The Dartmouth Institute has just published its Atlas of areal differences in utilization of prescription drugs by Medicare Part D recipients.  The Atlas--unsurprisingly but disturbingly--details significant differences.  Pharmaceutical interventions are classified as effective, discretionary (where there is diagnostic or therapeutic uncertainty), and likely to be harmful in the patient population at issue.  A caveat, however, is that the report measured prescriptions filled and thus may underestimate actual provider behavior.

An initial variation involved sheer numbers of prescriptions, with a high average of 63 per year in Miami and a low average of 39 per year in Colorado (overall, the average was 49 standardized 30 day prescriptions filled per year per Part D beneficiary).  In general, the Mountain West had the lowest prescription average and the Rust Belt and Appalachian states the highest.  These differences could not be explained primarily by overall burden of disease but instead appear to reflect variations in provider prescribing practices.  For example, the American Heart Association recommends use of beta blockers in heart attack patients for three years post-attack.  However, rates of prescriptions for these drugs in the first six months ranged from highs of 94% to lows of under 68%, and persistence in the next six months was only slightly lower, ranging from highs of 92% to lows of under 68%.  Variations in statin use were even greater, ranging from just over 91% in Ogden, Utah, to below 45% in Abilene, Texas.  Interestingly, there was little correlation between effective use of beta blockers and effective use of statins.

The other two therapies analyzed in the Atlas were treatment of diabetes and treatment of patients with fragility fractures.  Diabetic patients fared somewhat better than heart attack patients, albeit still with significant variations.  Osteoporotic patients, however, fared dismally, receiving a high of 28% and a low of 7% with filled prescriptions for drug to combat osteoporosis after fragility fractures in sites other than the hip (such treatment is recommended to decrease the risk of future hip fractures).

Most interesting of all, there was no correlation between drug expenditures and measures of effective care.  In other words, patients in some regions may be spending a great deal on their drugs (paid for under Part D), but receiving far less benefit that patients in other regions who spend a great deal less.

[LPF]

 

Published This Week

Jennifer Dunn, A Survey of Access to Trial of Labor in California Hospitals in 2012, SSRN.

Cynthia V. Ward, Mental Illness and Danger to Self, SSRN.

Barbara A. Noah, In Denial: The Role of Law in Preparing for Death, 21 Elder L. J. 1 (2013).

Marc A. Rodwin, Independent Drug Testing to Ensure Drug Safety and Efficacy, SSRN.

Alberto Alemanno, Amandine Garde, The Prevention of Non-Communicable Diseases in the European Union, Tania Voon, Andrew Mitchell & Jonathan Liberman, Regulating Tobacco, Alcohol and Unhealthy Foods: The Legal Issues, Routledge (Forthcoming).

Fernando Zegers-Hochschild, Bernard Dickens, Sandra Dughman-Manzur, Human Rights to In Vitro Fertilization,123 Int'l J. of Gynecology & Obstetrics 86 (2013).

Caroline Mala Corbin, Corporate Religious Liberty, SSRN. 

[KVT]

Call for Applications: Bernard J. Beazley Chair in Health Law and Policy

Bernard J. Beazley Chair in Health Law and Policy

Loyola University Chicago School of Law, a well established urban Jesuit law school, is currently seeking candidates to fill its recently created chair in health law and policy, named in honor of law school alumnus and donor Bernard J. Beazley.

This twelve month position will entail an appointment to an endowed chair to be made at the level of full Professor of Law.

Inquiries should be directed to Prof. Spencer Weber Waller, the chair of the search committee, at [email protected]. Interested candidates should submit an application here.

Continue reading

Call for Abstracts for the 2014 Petrie-Flom Annual Conference: Behavioral Economics, Law, and Health Policy

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: “Behavioral Economics, Law, and Health Policy.” Participants are invited to view the full call for applications here.

How to Participate

If you are interested in participating, please send a 1-page abstract of the paper you would plan to present to [email protected] as soon as possible, but not later than Monday, December 2, 2013.   If your abstract is selected, your final paper will be due in late March 2014, and you will be assigned a presentation slot for the conference dates.  Please note that presenters are expected to attend the conference for its full duration.  We will pay travel expenses for presenters who must travel to Cambridge; co-authored papers must name a single presenter.

How to Register

The conference will be held Friday and Saturday, May 2-3, 2014. Registration information is available here.  Attendance is free and open to the public, but space is limited.

Questions

Please contact Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, with any questions: [email protected], 617.384.5475.

[KVT]

Going to Seed: Urban Agriculture in Distressed Cities

The Law Review of the University of Detroit Mercy School of Law invites proposals for its 2014 Symposium, “Going to Seed:  Urban Agriculture in Distressed Cities,” scheduled for Friday, May 7, 2014.  This symposium will bring together both national scholars and local leaders to assess the role urban agriculture plays in the economic recovery of economically distressed cities such as Detroit, Cleveland, and Philadelphia.  Symposium organizers invite proposals for presentations and panels for the event.  Any topic related to urban agriculture will be considered; topics that dig into the ground-level details of current urban farming efforts in major American cities are especially welcome.  Relevant topic ideas could include regulatory issues such as zoning; permitting, water access, use, and discharge; chemical use and runoff, and developing physical and commercial infrastructure; as well as unique issues such as integrating agricultural animals into residential neighborhoods; food security and sustainability as a political, social, or theological priority; public and private liability for negligent or harmful agricultural practices; effects of urban agriculture on fundamental property law concepts, including, e.g., encroachment, boundary issues, nuisance, restrictive covenants, or eminent domain; as well as creative, outside-the-box topics that connect with urban agriculture and economic recovery in new ways.

Special Features:  Scholars whose proposals are accepted will be invited to join Symposium organizers for a tour of local urban agriculture projects.  

Deadline:  E-mail submissions of 500 words or less must be received no later than Monday, December 2, 2013, and should be directed to Ms. Gerta Rapo, Law Review Symposium Editor, University of Detroit Mercy School of Law / Law Review, at [email protected].  Accepted proposals will be considered as possible publication topics for a special symposium edition of the UDM Law Review; editorial staff will follow up with selected speakers regarding the details and deadlines for publication.

Additional Info: Questions regarding the Symposium or the proposal process should be directed to Law Review Symposium Editor Ms. Gerta Rapo, [email protected], University of Detroit Mercy School of Law / Law Review, 651 E. Jefferson Ave., Detroit, MI 48226 (ph. 313-492-6318). 

[KVT]

AALS Section on Law, Medicine & Health Care Programs

AALS Section on Law, Medicine & Health Care

 2014 Section Program

 Sustainability and Health

 Saturday, January 4, 2014, 2:00–3:45 p.m.

 Ani B. Satz, Emory University School of Law, Moderator

Stephen Miller, University of Idaho School of Law, The Police Power and Public Health in the Age of Sustainability

Melissa Powers, Lewis and Clark Law School, Climate Action Plans and Urban Pollution

Laurie Ristino, Vermont Law School, Food Policy for Improving Sustainability and Health: A Proposed Legal Framework

Mark Izeman, NRDC, Emerging Trends in Regional Food Law: Implications for Sustainability and Health

Ashley Rhinehart, Humane Society of the U.S., Factory Farming, Sustainability, & Public Health

Joanna Sax, California Western School of Law, Revisiting the Role of the Value of a Statistical Life Through Fracking

This panel will explore the effects of the environment on health in western nations and the role that sustainability initiatives play with regard to wellness. The panel will be interdisciplinary, broadly spanning topics in health, environmental, and animal law and policy as well as public health, land use, and urban planning.

Proceedings will be published in the Journal of Law, Medicine & Ethics.

   

2014 Co-Sponsored Program

In Partnership with the Section on Nonprofit and Philanthropy Law

The Role of Nonprofits Under the Affordable Care Act

Friday, January 3, 2014, 10:30 a.m.–12:15 p.m.

Kathleen M. Boozang, Seton Hall University School of Law, Policies Addressing Care and Reimbursement for Undocumented Patients

Erin C. Fuse Brown, Georgia State University College of Law, Fairness Is Not Charity: The Inadequate 501(r) Charge Limit and Collection Rules for Tax-Exempt Hospitals and a Proposal for Expansion

Mary Crossley, University of Pittsburgh School of Law, Nonprofit Hospitals as Partners in Community Health Improvement:  Lessons from the Community Reinvestment Act

Thomas (Tim) L. Greaney, Saint Louis University School of Law, Nonprofit Hospital Conversions and Closings after Health Reform

Mark A. Hall, Wake Forest University School of Law, Nonprofit Health Insurance Cooperatives: A Weak Idea that Might Actually Help

Robert A. Katz, Indiana University McKinney School of Law, American Exceptionalism: The U.S. Tax Code's Refusal to Treat Health Care as a Per Se Charitable Purpose

Jean Wright Veilleux, Charlotte School of Law, Unlikely Hero: How the IRS Can Use Its Regulatory Authority to Rescue the Medicaid Program

 Catherine E. Livingston, Jones Day, Commentator

This panel will address the role of nonprofit organizations under the Affordable Care Act of 2010 ("ACA"). Broad topics include: the ACA’s new requirements for 501(c)(3) tax-exempt hospitals; Care and Reimbursement for Medicaid and Undocumented Patients; and nonprofit Consumer Operated and Oriented Plans (CO-OPs).

Proceedings will be published in the Indiana Health Law Review.

[KVT]

The Journal of Law and Health is Extending Call for Papers for 2014 Symposium on Reproductive Rights

The Journal of Law and Health is extending its Call for Papers through the month of October.

Our upcoming Symposium titled Issues of Reproductive Rights: Life, Liberty, and the Pursuit of Policy will be held in March 2014 in Cleveland, Ohio. If you are writing on issues related to reproductive rights please consider submitting an abstract and CV for consideration. The abstract should be no longer than 600 words.

The selection of this Symposium topic was a result of  major developments in the area of Reproductive Rights in the past year. For example, state legislation in Texas and several other states restricting access to abortion. Another example would be the recent 10^th Circuit decision in Hobby Lobby v. Sebelius which provided for-profit corporations with a right to challenge the Affordable Care Act’s so-called “contraceptive mandate” on the basis that a corporation is a “person” who can have and exercise its own religious beliefs. The Symposium aims to give judges, legislators, and academics the opportunity to present research that highlights the legal and ethical issues that may occur because of these developments.

If you are interested in submitting an abstract for consideration please find the instructions and important dates for submission below.

Thank you so much for your time and consideration and we look forward to hearing from you.

Abstract and CV deadline: October 31, 2013

• Abstracts should be no longer than 600 words.

Offer Date deadline: November 15, 2013

• The Journal of Law and Health will contact by this date, if it is interested in publishing your paper.

Final Version deadline: August 1, 2014

• Your final draft of the paper is due on this date. Once papers are collected, the Journal will begin its editing process.

Symposium Presentation: March 7, 2014

• As part of the publication, every author is required to present at the Annual Journal of Law and Health Symposium. The Journal will be able to reimburse/pay for travel expenses of speakers. Please contact Gordon Gantt, if you have any further questions regarding the symposium.
  

Important Contact Information:

Editor-in-Chief: Lauren Orrico 412-956-5917

Senior Editor: Gordon Gantt 703-638-5016

Submissions: http://law.bepress.com/expresso/

If you have any additional questions, please feel free to contact Gordon Gantt at [email protected].

[KVT]

Fellowship - Call for Applications: The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

 

The Petrie-Flom Center is now accepting applications for 2014-2016 Academic Fellowships.

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to scholarly research at the intersection of law and health policy, including issues of health care financing and market regulation, biomedical research and innovation, and bioethics. The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate, and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics, and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy, or bioethics. Our prior fellows have found employment as law professors at institutions such as Harvard, UC Berkeley, BU, UCLA, Cornell, the University of Illinois, and the University of Arizona.

Applications will be accepted starting September 16, 2013. Completed applications must be received at [email protected]  by 9:00 a.m. on November 18, 2013.

The full call for applications can be found here or contact Administrative Director Cristine Hutchison-Jones.

[Cross posted from Bill of Health]

 

[KVT]

Published This Week

Hosea H. Harvey, Reducing Traumatic Brain Injuries in Youth Sports: Youth Sports Traumatic Brain Injury State Laws, January 2009-December 2012, 103 Am. J. of Pub. Health 1249 (2013).

Jacob S. Sherkow, Henry T. Greely, The Future of Gene Patents and the Implications for Medicine, 173 JAMA Internal Med. 1569 (2013).

Susan A. McMahon, It Doesn't Pass the Sell Test: Focusing on 'The Facts of the Individual Case' in Involuntary Medication Inquiries, 50 Am. Crim. L. Rev. 387 (2013).

Ryan Abbott, Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, 99 Iowa L. Rev. 101 (2013).

Christopher T. Robertson, David V. Yokum, Megan S. Wright, Perceptions of Efficacy, Morality, and Politics of Potential Cadaveric Organ Transplantation Reforms L. & Contemp. Probs. (Forthcoming 2013).

Dana Beldiman, Commercialization of Genetic Resources: Leveraging of Ex Situ Genetic Resources to Shape Downstream IP Protection, SSRN.

Steven Penney, Irresistible Impulse and the Mental Disorder Defence: The Criminal Code, the Charter, and the Neuroscience of Control, 30 Crim. L. Q. (Forthcoming 2013).

Diane Zuckerman, Sonia Nagda, Public Health Implications of Differences in US and European Union Regulatory Policies for Breast Implants, 20 Reprod. Health Matters __ (2012).

Ryan Abbott, Michael Cohen, Medico-Legal Issues in Cardiology, 21 Cardiology in Rev. 222 (2013).

Michael L. Perlin, Mental Disability, Factual Innocence and the Death Penalty, Crime & Crim. Just. in Asia __ (2013).

David Hunter, How to Object to Radically New Technologies on the Basis of Justice: The Case of Synthetic Biology, 27 Bioethics 426 (2013).

[KVT]

Federal-State Tensions in Fulfilling the ACA's Promises

[Cross posted today at Constitution Daily:]

The Affordable Care Act expresses many goals, but its heart is the desire to create a health insurance home for all Americans.  The American healthcare system historically exists at the pleasure of a number of stakeholders and is not a coherent whole. This lack of system is reflected in the consistent tensions that underlie American healthcare, most notably federal power versus state power; the collective versus the individual; and the individual versus the state.  In creating near-universal health insurance, the ACA has resolved one of those tensions, individual versus the collective, in favor of the collective.  To that end, the ACA eliminated many of the practices health insurers used to cherry pick policyholders, which excluded people who need medical care from their risk pools.  In so doing, the ACA represented a federal choice to make all people insurable, whatever their wealth, age, medical history, sex, race, or other distinguishing factor. 

Despite the redirection this leveling of the health insurance playing field represents, the ACA did not craft a coherent whole out of the American healthcare system.  Instead, the ACA remodels the preexisting, unstable healthcare system.  In building on the old foundation rather than starting anew, the law retained the historic role of the states in regulating medical matters.  To that end, the ACA urged the states to implement two key aspects of its insurance modifications: Health Insurance Exchanges and the expansion of the Medicaid program.  The federal government has the power under the Spending Clause to create a federally-run insurance mechanism, but it chose instead to employ cooperative federalism to keep states engaged in healthcare policymaking.  The trouble is that some states have not been cooperating with these central legislative goals.

 The Exchanges, or Marketplaces, are an instrument through which qualified private health insurance plans can be purchased by individuals or small businesses.  The states were offered federal funding to create their own state-run Exchanges, which were operative as of October 1, 2013 (Tuesday last week).  Many states created Exchanges, but many rejected them as an expression of their distaste for the ACA.  Predictably, many of the states that have refused to create their own Exchanges were the same states that challenged the constitutionality of the ACA.  While there is value in dissent, the states that refused to create Exchanges invited more federal power into the state, because rejecting the federal offer for funding to create a state-run Exchange did not halt Exchanges from coming into existence. Instead, the ACA tasked the federal government with operating Exchanges in states that did not create their own.  While expressing a desire to protect their state sovereignty, these states have invited federal authority into their borders.  Though the Exchanges at both the state and federal levels have experienced some technical glitches this week, it appears that many people are eager to purchase insurance through them and that they have been successful at doing so.  The states that rejected Exchanges have not stopped implementation of the law, but their actions have other notable ramifications.

The Medicaid expansion was designed to catch childless adults under age 65 and below 133% of the federal poverty level in Medicaid’s safety net.  As with other modifications to the Medicaid program over the years, the expansion added a new element to the Medicaid Act that states could reject, but they could lose all of their funding if they made that choice.  The day the ACA was signed into law, states challenged the expansion of the Medicaid program as unconstitutionally coercive.  They succeeded on this claim in NFIB v. Sebelius, and the Court rendered the expansion optional for states. Immediately pundits began to question whether the states would participate in the Medicaid expansion. 

Though national media tallies make it appear that just over half of the states are participating in the Medicaid expansion, in reality the number is and will be much higher.  In almost every state reported as “leaning toward not participating,” and in many states reported as “not participating,” some significant act has occurred to explore implementation of the Medicaid expansion.  Some states have special commissions or task forces researching expansion; some state governors have indicated a desire to participate and have included the expansion in the budget; some legislatures have held debate or scheduled it for the next session; and so on.  Though some states will not have their Medicaid expansions running by January 1, 2014, it seems very likely that most if not all states will participate in the expansion in the relatively near future.

 In the meantime, state non-cooperation will have a direct effect on some of the nation’s poorest citizens.  People from 100% to 400% of the federal poverty level are eligible to receive tax credits for purchasing insurance in the Exchanges.  In states with no expansion, people above 100% of the federal poverty level who would have qualified for Medicaid will still be able to obtain insurance through federal subsidies in the Exchanges.  But, people who are below 100% of the federal poverty level will be too poor for tax-credits and living in states that have not yet expanded their Medicaid programs, therefore they will not be able to enroll in Medicaid either.  These very low income people will not be penalized for failing to carry health insurance, but they will not have health insurance either.  These individuals will get caught in a health insurance black hole that exists in part because the Court allowed states to refuse Medicaid expansion and in part because of state resistance to partnering in the implementation of the ACA.   

State cooperation in the Medicaid expansion is even more important than state participation in the Exchanges, because many thousands of people may not get the access to health insurance that is the promise of the ACA.  The debate over the meaning of federalism that swirls around political and academic circles will have a direct and important effect on the people who can least afford it.  The good news for them is that Medicaid’s history indicates that all states eventually participate in the program and its amendments, but this week’s implementation of the Exchanges keeps access to medical care through health insurance tantalizingly out of reach.

What's Happening to HHS with the Shutdown?

The federal government shutdown will shutter all non-essential services.   Sadly, this means a hiatus for many programs designed to protect public health, such as CDC's seasonal influenza  or outbreak protection programs.  It means suspension of many programs serving vulnerable populations:  HeadStart, senior nutrition, elder abuse prevention, and refugee programs.   It means that programs designed to improve health IT or quality measurement will be on hold, as will efforts to monitor grants under programs such as SAMHSA or to measure performance of Medicare or Medicaid providers.   Some of these programs may be able re-start roughly where they stopped when the government re-opens, of course with the costs of suspension and delay.  But others may result in irretrievable harm, from individuals victimized by abuse to spread of an undetected infectious outbreak.

Some programs will continue, primarily those devoted to patient care. The Indian Health Service will continue to operate, Medicare will continue to pay physicians, and NIH will not discharge current patients into the streets.  Medicaid will continue to operate and to pay providers.  HHS will provide support for the ACA rollout, including interfaces with state Medicaid.

Over half of HHS employees will be without work or pay--surely demoralizing in light of sequestration furloughs and the prospect that Congress may not in the end make it up to them for lost days at work.

HHS's full description of what can only be described as a health disaster of garguantuan proportions can be found here.

[LPF]

Happy Exchange Day!

Despite best efforts to prevent the exchanges, or marketplaces, from going on line, today the exchanges have begun to do the work of facilitating a health insurance home for people in the United States.  If you live in a state that has declined to create its own exchange, then you should visit https://www.healthcare.gov/, the federal website for the federal health insurance marketplace.  Though there were reports of the site crashing, as of 3:00 this afternoon it seems to be working.  And, the site will guide you to your state's marketplace site, as necessary.  No need to rush though, as open enrollment lasts through March of 2014.

Many probably saw Governor Beshear's op-ed in the New York Times last week regarding the reasons that Kentucky has created its own state-based exchange (and will accept federal funding for the Medicaid expansion), here.  The commentary seems even more relevant in the wake of the House Republicans shutting down the federal government over health insurance.