Navigating the New Field of International Health Law, Featuring Gian Luca Burci, Legal Counsel for WHO

gian_luca_burci_world_health_organization_2This lecture, “Navigating the New Field of International Health Law,” will explore the intersection of health and international law and the emergence of International Health Law as a practice area. Featuring Gian Luca Burci, Legal Counsel for the World Health Organization, this program will focus on the growing interactions between health policy and various areas of international law, including international business transactions, intellectual property, international security, and human rights law. The program is sponsored by the Seton Hall Law Center for Health & Pharmaceutical Law & Policy and the International Law program at Seton Hall Law.

The event will take place at Seton Hall Law, Newark, NJ, on Wednesday, February 22, 6 to 7 p.m.  There is no charge. 1 New Jersey CLE credit will be available. Click here to make your reservation or for more information, please contact Sara Simon, Director, Healthcare Compliance Certification Program, at sara.simon@shu.edu or call 973-642-8190.

Share/Save/Bookmark

Cuts in Mental Health Funding Continue; Supreme Court to Rule

January 22, 2012 by Zack Buck · 1 Comment
Filed under: Health Law, Medicaid, Mental Health 

zack-buck_4As America waits for the U.S. Supreme Court to hear oral arguments in, and decide on, the constitutionality of the Patient Protection and Affordable Care Act of 2010 (PPACA) in March, state cuts in mental health funding continue unabated in many states throughout the country.  As previously mentioned here, the PPACA review undertaken by the Court will not only focus on the constitutionality of the individual mandate but will also examine PPACA’s Medicaid expansion.  By expanding Medicaid, PPACA will provide coverage to millions of those living with serious mental illness.  PPACA also provides for increased community-based outreach, from changing the waiver laws to awarding grants for new programs, in order to further improve essential services for those living with mental illness.

While many fixate on late March, local governments continue a practice that started a few years ago:  slashing funding for mental health services.  Just last week, Chicago’s Department of Public Health announced they were closing half of their mental health clinics — disproportionately affecting the city’s African-American and Hispanic populations, according to advocates.  Over the last fiscal year, New York has cut its mental health budget by $95 million, and California has by $177 million.  According to a new NAMI study released late last year, from 2009 to 2012, four states have slashed their mental health expenditures by more than 30 percent; South Carolina, at the top of the list, has cut funding by nearly 40 percent.  Alaska and Nevada — the two states with the highest suicide rates in the country — are both in the top five.  In total, “general funds for mental health” are down $1.6 billion overall between 2009 and 2012.

Besides painful, the cuts are likely to be counterproductive:  advocates argue that they will actually cost states more in the long run.  Ronald Hornberg, director of legal and policy affairs at NAMI recently told ABC news that the cuts are resulting in those in need of services showing up in emergency rooms or prisons, where they are expensively boarded because there is nowhere else for them to go.   Eric Lindquist, a clinical therapist at the Chicago Department of Public Health, called the mental health clinics that Chicago has decided to cut, when compared to hospitalizations or incarcerations, “one of the taxpayer’s best bargains.”

At the same time, headlines late last week brought news that 20 percent of Americans were diagnosed with mental illness in 2010 — nearly one in four women and about one in six men.  Among other findings, nearly nine million Americans “thought seriously” about suicide in 2010, with over one million attempting to kill themselves.  Almost two million teenagers “experienced a major depressive episode.”  Those aged 18 to 25 had the highest incidence of illness:  nearly 30 percent.

Obviously, the incidence of illness and prevalence of spending cuts nationwide does not bode well for the future of mental health care in this country.  Those that depended on the services being cut are left to try and make it on their own, and those who worked for gutted agencies are looking for jobs.  And this is why advocates look toward March.  The Court’s decision later this year will shape the future of mental health services in this country for years to come — services that, right now, are increasingly endangered nationwide.

Share/Save/Bookmark

Professor Frank Pasquale featured in The Record on ‘A Constitutional Right to Health Care’

January 18, 2012 by Michael Ricciardelli · Leave a Comment
Filed under: Health Law, Health Reform 

constitution_of_the_united_states_2009djvuProfessor Frank Pasquale wrote a featured Op-ed in The Record, New Jersey’s most awarded newspaper, regarding a constitutional right to health care. Professor Pasquale, who is Associate Director of the Center for Health & Pharmaceutical Law & Policy and Editor in Chief of HRW, writes:

SHOULD the Supreme Court weigh in on America’s great health care debate? Yes. It should declare a constitutional right to health care.

This right is already enjoyed by prisoners. Law-abiding citizens deserve it, too.

The United Nations’ Universal Declaration of Human Rights states, “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including… medical care.”

Many advanced countries have adopted - and lived up to - similar commitments.

Of course, that’s not on the Supreme Court’s agenda. Instead, it will decide whether to cripple last year’s health reform, known as the Affordable Care Act, by declaring the individual mandate unconstitutional.

I understand objections to the mandate. Cash-strapped Americans don’t deserve one more drain on their resources. I’m also not a fan of making people buy health insurance from private insurers. They waste a lot of money, and are one reason why U.S. doctors’ administrative costs are a whopping 400 percent higher than those in Canada.

If I designed the ACA, I’d have given everyone a public option, modeled on Medicare.

But I didn’t write the bill, Congress did. In precedents going all the way back to the 1819 case of McCulloch v. Maryland (and affirmed as recently as 2010), the Supreme Court has deferred to Congress’s constitutional powers to solve national problems.

Politics

The court risks looking political if it abandons that approach now. It has already jettisoned once-venerable holdings on campaign finance, equal protection and antitrust.

Read the full Op-ed here.

Share/Save/Bookmark

AALS Panel on Teaching Health Law: A Tour de Force

January 14, 2012 by Frank Pasquale · 1 Comment
Filed under: Health Care Employment, Health Law, Uninsured 

pasqualeThe health law section at AALS put on a truly outstanding program.  Jennifer Bard posted on the speakers and topics here, and I’d wanted to do a post reporting on the program.  But there was so much there that I’ll try to draft a post on each speaker, or at least a column from the Journal of Law, Medicine, and Ethics that reflects her or his approach.  Fortunately, as Bard reported, “the Indiana University Robert H. Mckinney School of Law’s Health Law Review has agreed to print pieces about these programs as well as the proceedings of the panel in a Spring 2012 volume.”

The first speaker was Prof. Charity Scott,  Catherine C. Henson Professor of Law and Director of the Center for Law, Health & Society at Georgia State University College of Law.  Her presentation, “Collaborating with the Real World: Opportunities for Developing Skills and Values in Health Law,” was a terrific mix of high level observation, on-the-ground experiences, practical examples from her own health law program, and articles she edited as editor of the Teaching Health Law column of the JLME.  Scott noted that experiential learning can happen in time slots ranging from an hour to a day to a semester or year, so any committed professional can fit some opportunities into their schedule at some point.  She particularly focused on how students could help attorneys, doctors, and community members solve pressing problems.  In coming weeks, I’ll blog on some of the particular programs she mentioned.

Share/Save/Bookmark

Constitutional Mortality: Precedential Effects of Striking the Individual Mandate

November 24, 2011 by Mark Hall · Leave a Comment
Filed under: Health Law 

Professor Mark Hall, Fred D. & Elizabeth L. Turnage Professor of Law, Wake Forest University School of Law

mark-a-hallAbstract:

Because insurance is necessary for decent access to health care, credible studies estimate that eliminating the Affordable Care Act or its individual mandate could cause thousands of avoidable deaths a year. That is sobering, but far more chilling is the loss of life that might result from the constitutional precedent that a negative ACA ruling would set. If the challengers’ chief argument is accepted, it creates the frightening prospect that the federal government may be unable to respond effectively to a catastrophic public health emergency that threatens millions of lives, if effective response requires mandating citizen behaviors unconditioned on any engagement in commerce.

Credible scenarios for natural disasters and flu pandemics might require just such federal actions, in the form of mandatory vaccination, evacuation, screening, treatment, or even mundane sanitary measures — and the Commerce Clause is the only source for such power when military defense is not involved. State and local governments are the primary source of authority for such measures, but recent disasters and near-misses demonstrate the real possibility that their responses may prove inadequate. Thus, rather than fretting over what slippery-slope vegetables the government might force people to purchase if the mandate were upheld, courts should be much more concerned about the insurmountable barriers that a nullifying precedent would set for effective federal response to realistic catastrophes.

[Ed. Note: Professor Hall's paper may be found here]

Share/Save/Bookmark

Does the Fee Imposed by Section 9010 of the Affordable Care Act Apply to Stop-Loss Coverage?

jostIt was the intent of Congress in enacting the Patient Protection and Affordable Care Act to regulate health insurance comprehensively. Most of the regulatory provisions of Title I (the insurance reforms) apply to “A group health plan and a health insurance issuer offering group or individual health insurance coverage.” The definitions of these terms are drawn from the definitional section of the Public Health Services Act (added by the Health Insurance Portability and Accountability Act), which defines a “group health plan” as an ERISA plan, and a “health insurance issuer” as “an insurance company, insurance service, or insurance organization (including a health maintenance organization, as defined in paragraph (3)) which is licensed to engage in the business of insurance in a State and which is subject to State law which regulates insurance.” 42 U.S.C. § 300gg-91(a)(1), (b)(2). Thus the ACA covers both self-insured ERISA plans and insured individual and group plans.

In fact, however, the ACA does not apply to all health insurance coverage, and does not apply to all health insurance coverage to which it does apply to the same extent.  HIPAA excepted benefit plans, including specific disease and fixed-dollar indemnity plans, and short term individual coverage are not subject to ACA requirements, and many of the provisions of the ACA that apply to individual and small group plans, including the essential benefit package, the risk adjustment program, and the risk pooling, community rating, minimum medical loss ratio, and unreasonable premium increase justification requirements do not apply to self-insured plans.  It is, therefore, important to read the ACA section by section to determine which requirements or prohibitions apply to which types of health insurance.

One particularly important provision that has not received enough attention is section 9010, “Imposition of Annual Fee on Health Insurance Providers” (at 811-815 in the link).   This provision is found in Title IX of the ACA, but was amended both by the December 2009 Managers’ Amendment, which became Title X, and by the Health Care and Education Reconciliation Act, enacted in March 2010.  Section 9010 imposes a fee, beginning in 2014, on a “covered entity’s net premiums written with respect to health insurance for any United States health risk.” The fee is determined by multiplying the fraction determined by dividing the covered entity’s net premiums by the net premiums of all covered entities that are taken into account under the statute times a set annual amount, which begins at $8 billion, but rises to $14.3 billion by 2018.  This fee will be an important revenue source for funding the ACA’s coverage expansions.

The fee imposed by section 9010 does not apply to all insurers equally.  Insurers with annual net premiums of $50 million are fully taxed on their revenues, while insurers with annual net premiums of $25 to $50 million are taxed on only half of their net premium revenues, and insurers with net premiums below $25 million are not taxed at all.  Certain tax-exempt insurers are also taxed on only half of their net premium revenues (after applying the small insurer discount just mentioned).

The fee also only applies to “covered entities.”  Section 9010(c) defines “covered entity” as an entity that “provides health insurance for any United States health risk,” subject to a number of exclusions.  These exclusions include “any employer to the extent that such employer self-insures its employees’ health risks;” government entities; certain non-profit insurers that derive 80% of their revenue from government programs; and VEBAs that are tax exempt under I.R.C. § 501(c)(9).What is the universe of “covered entities,” however, that remain subject to § 9010 after these exclusions are applied?

To answer this question it is necessary to parse the meaning of “health insurance” and “United States health risk.”  Both terms are defined in the section, but only in part.  “United States health risk” is defined to include the health risk of an individual who is a United States citizen, resident, or located in the United States. § 9010(d).  “Health insurance” is defined to exclude certain but not all forms or HIPAA excepted benefits (as defined in I.R.C. § 9832(c)), long-term care insurance, and Medicare supplemental insurance.  Nowhere in § 9010, or indeed anywhere in the Internal Revenue Code, however, are the terms “health insurance” or “health risk” defined.  Section 9010 tells us what “health insurance” is not, but not what it is.

The most interesting question is whether health insurance for a United States health risk includes stop-loss coverage.  The sale of stop-loss coverage to small employer groups is increasing very rapidly.  As noted above, self-insured small groups are not subject to many of the consumer and market protections that the ACA applies to insured small groups.  Self-insured group plans are also not subject to state regulation because of ERISA preemption.  There is thus a great deal of interest in the part of small group plans in self-insuring.  Small groups can only self-insure, however, if they can find generous stop-loss coverage that will assume most of the health risk of employees.  A small employer that fully assumed coverage for its employees without stop-loss coverage would face unacceptable risk.  Some insurers, therefore, are actively marketing stop-loss coverage, often with very low attachment points, to small groups.

Is this stop-loss coverage subject to section 9010?  It certainly is “insurance” and it certainly covers a “health risk.”   It also does not fit within any of the explicit exclusions from the term “health insurance.”  But is “stop-loss insurance” “health insurance”?  The term “health insurance” is nowhere defined in the Internal Revenue Code (which would be the relevant code since the fee is administered by the Secretary of the Treasury and the fee is considered to be an excise tax, see § 9010(f),(h)(1)).  “Health insurance coverage” and “Health insurance issuer” are defined in § 9832, but those are not the terms used in section 9010, presumably intentionally.  By analogy, the term “group health plan” is used throughout the ACA to mean an ERISA plan, but in § 1301(b) the term “health plan” is explicitly defined to not include self-insured ERISA group plans.  Wherever the term “health plan” is used in the ACA without the adjective “group,” therefore, it does not include self-insured ERISA plans, but where it appears with the adjective “group” self-insured plans are included.  Similarly, it must be presumed that Congress used the term “health insurance” to mean something different from the defined terms “health insurance coverage” or “health insurance issuer,” which terms are used throughout the ACA in different contexts.

Is stop-loss insurance that covers health care risks health insurance?  This is certainly a reasonable interpretation of the term.  Moreover, the fact that Congress explicitly excluded from the definition of “covered entity” risk borne by employers in self-insured plans, but not risk that they pass on to stop-loss insurers, indicates that Congress did not intend to exempt stop-loss plans from the fee.

Applying the fee to stop-loss coverage would help to level the playing field between conventional health insurers and health insurers that insure health risk through stop-loss plans, and might help stem the flood of small groups to self-insured status, which in turn threatens to undo the consumer protections extended to employees insured through small groups and the market protections built into the ACA to stabilize the small group market (such as the risk adjustment and risk pooling requirements).

Section 9010(c) tasks the Secretary of the Treasury with providing implementing regulations and guidance.  It is to be hoped that the Secretary will clarify through the regulatory process that the § 9010 fee applies not only to conventional insurance, but also to stop-loss insurance.  Stop-loss insurance increasingly serves as an alternative mechanism for covering the same health risks that are covered by conventional insurance, while at the same time providing a means of evading ACA consumer and market protections.  Section 9010 should be applied to stop-loss insurance just as it is to conventional insurance.

Share/Save/Bookmark

ACO Symposium: Professor John V. Jacobi to Present: Lessons from ACO Implementation in New Jersey

Professor John V. Jacobi,

Professor John V. Jacobi, Faculty Director, Center for Health & Pharmaceutical Law & Policy, Dorothea Dix Professor of Health Law & Policy, Seton Hall University School of Law

In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is John V. Jacobi , Faculty Director, Center for Health & Pharmaceutical  Law & Policy,Dorothea Dix Professor of Health Law & Policy, Seton Hall University School of Law. Professor Jacobi, who frequently contributes to HRW,  will take part in the panel on “ACOs in Practice: Research on Current Implementation of ACOs,” and will be presenting Lessons from ACO Implementation in New Jersey.

Professor John Jacobi’s work is primarily in the areas of Health Insurance and Access, Mental Health Law, and Disability Law.

Professor Jacobi received his B.A., summa cum laude, from the State University College of New York at Buffalo and his J.D., magna cum laude, from Harvard Law School. He teaches Health Law, Health Finance, Disability Law, Public Health Law, Mental Health Law, and Torts. Professor Jacobi spent five years working for the New Jersey Department of the Public Advocate as Special Assistant to the Commissioner, where he worked on health, civil rights, and disability issues through litigation and advocacy in legislatures and regulatory agencies. He then became a Gibbons Fellow at the law firm of Gibbons, Del Deo, Dolan, Griffinger & Vecchione, where he pursued health, prisoners’ rights, and disability issues. During 2007-2008 he was on leave from the law school, serving as Senior Associate Counsel to N.J. Governor Jon S. Corzine on Health, Human Services, and Chrildren’s Issues.

Professor Jacobi writes and speaks on issues including disability rights, health access and finance, public health, and mental health. His recent and current scholarly projects include examining the improvement of chronic care in health systems, the funding and structure of Early Intervention Services for children with disabilities, examining the obligations of government to provide services to people with serious mental illness, the clash of disability rights and public health interests, and the prospects and social effects of “consumer-driven” health insurance models on health costs and rights of access for the poor and people with disabilities. He served on the Governor’s Task Force on Mental Health, the Board of Advisors of the New Jersey Office of Child Advocacy, the New Jersey Olmstead Advisory Council on disability rights, and on other government and non-profit boards and committees.

Share/Save/Bookmark

ACO Symposium: Professor Sallie Sanford to Present: State-based ACO and Medical Home Pilots: Early Lessons from the Other Washington

sanford

Sallie Sanford, Assistant Professor of Law, University of Washington School of Law & School of Public Health

In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Sallie Sanford, Assistant Professor of Law, University of Washington — School of Law & School of Public Health. Professor Sanford will take part in the panel on “ACOs in Practice: Research on Current Implementation of ACOs,” and will be presenting State-based ACO and Medical Home Pilots: Early Lessons from the Other Washington.

Professor Sanford teaches Health Law both at the law school and the School of Public Health. Her research interests include health care delivery systems, health administration law, Medicare and Medicaid, comparative health law, and medical and administrative ethics.

Professor Sanford began her legal career as a law clerk for The Honorable Robert R. Beezer of the United States Court of Appeals for the Ninth Circuit. She then served for six years as an Assistant Attorney General representing the University of Washington Medical Center, Harborview Medical Center and the UW’s health sciences schools. Professor Sanford is a member of the Order of the Coif and is admitted to practice in Washington and the U.S. Court of Appeals for the Ninth Circuit. She is the president of the Washington State Society of Healthcare Attorneys.

Share/Save/Bookmark

ACO Symposium: Hal Teitelbaum, CEO & Managing Partner, Crystal Run Healthcare to Present, The Prospect of Being Hanged: Focusing the Physician Mind on ACOs

Hal Teitelbaum, M.D., MBA and CEO & Managing Partner, Crystal Run Healthcare

Hal Teitelbaum, M.D., MBA and CEO & Managing Partner, Crystal Run Healthcare

In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Hal Teitelbaum, M.D., MBA, and CEO and Managing Partner, Crystal Run Healthcare; he will take part in the panel concerned with the “Introduction to Accountable Care Organizations,” and will be presenting The Prospect of Being Hanged: Focusing the Physician Mind on ACOs.

Hal Teitelbaum is the managing partner, CEO and founder of Crystal Run Healthcare, among the largest, fastest growing and most technically advanced medical practices in New York State. Dr. Teitelbaum completed his training in Internal Medicine at New York Hospital-Cornell Medical Center, and in Medical Oncology and Hematology at Memorial Sloan-Kettering Cancer Center. After beginning his career in full-time academic practice, Dr. Teitelbaum established a solo practice in Orange County, New York, in 1982.  He established Crystal Run Healthcare in 1996.  He is a 1998 honors graduate of Columbia Business School, where he earned his MBA and is currently enrolled in Columbia Law School, Class of 2012.

Dr. Teitelbaum has served as a trustee of Horton Medical Center and in numerous other capacities for the hospital, medical staff organization, managed care organizations and regulatory agencies.  He is a recipient of the ADL Americanism Award, the Rhulen Award of the Sullivan County Partnership for Economic Development, and the Alliance for Balanced Growth’s ‘Golden Shovel Award’ of the Orange County Partnership. He was recognized by the Medical Group Management Association (MGMA) as the 2006 Physician Executive of the Year. Over the years, Dr. Teitelbaum and Crystal Run Healthcare have been the subjects of numerous articles for health care and business publications.

Share/Save/Bookmark

ACO Symposium: Jorge Lopez, Partner, Akin Gump, to Present: Promise and Pitfalls: Health Reform’s Medicare ACO Shared Savings Program

jorge-lopezIn conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Jorge Lopez, Partner, Akin Gump Strauss Hauer & Feld LLP; he will take part in the panel concerned with the “Introduction to Accountable Care Organizations,” and will be presenting Promise and Pitfalls: Health Reform’s Medicare ACO Shared Savings Program.

Jorge Lopez Jr. heads the national health industry practice and is a member of the firmwide management committee at Akin Gump, working out of the DC office. The health practice’s clients include major academic medical centers, health care systems, manufacturers of drugs and devices, managed care enterprises, lenders and investors involved with health industry projects and various other health care-related enterprises.

Mr. Lopez has more than two decades’ worth of experience advising these clients on a wide range of health regulatory and public policy issues. He has advised clients on many of the major Congressional health care initiatives considered in the past 20 years-including the Clinton Administration health care reform proposal, the Balanced Budget Act of 1997, the Medicare Modernization Act of 2003 and the Affordable Care Act of 2010-and the implementation of many of these initiatives by the federal Centers for Medicare and Medicaid Services. He has particular experience in matters involving health care policy and regulation affecting cancer care; applications of the federal fraud and abuse laws to the hospital, pharmaceutical, pharmacy and medical device industries; and issues relating to the Health Insurance Portability and Accountability Act (HIPAA) and other state and federal privacy laws.

Mr. Lopez is nationally ranked as a top healthcare lawyer in the 2008-2011 editions of Chambers USA: America’s Leading Lawyers for Business. He is very active in charitable organizations in the Washington, D.C. community. He has served on the board of directors of the D.C.-area Catholic Charities or one of its affiliates since 1985. He was board chairman of one of these affiliates, Anchor Mental Health, a large provider of services to mentally disabled adults in the D.C. area, from April 2003 to June 2004.

Share/Save/Bookmark

ACO Symposium: Profesor Priscilla D. Keith to Present:The Impact of Accountable Care Organizations on Public Health

Priscilla Keith, Adjunct Professor and Director of Research and Projects, Hall Center for Law and Health, Indiana University School of Law - Indianapolis

Priscilla Keith, Adjunct Professor and Director of Research and Projects, Hall Center for Law and Health, Indiana University School of Law - Indianapolis

In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Priscilla Keith, Adjunct Professor and Director of Research and Projects, Hall Center for Law and Health, Indiana University School of Law — Indianapolis.

Professor Keith will take part in the panel concerned with “ACOs in Theory: Issues Raised by Integrated Delivery,” and will be presenting The Impact of Accountable Care Organizations on Public Health.

Priscilla D. Keith serves as Director of Research and Projects, as well as Adjunct Professor, at Indiana University Law School’s Hall Center for Law and Health. As Director, she manages the legal and policy research projects of the Center. She is also responsible for the development of the curriculum and other arrangements for the graduate law degree program (L.L.M.) in health law, policy and bioethics. Before returning to work for her alma mater, Keith served as the General Counsel of the Health & Hospital Corporation of Marion County, in Indianapolis, including Wishard Health Services, the Marion County Health Department, and Environmental Services. Her primary focus was litigation, corporate transactions, and risk management, and serving as the counsel for the Marion County Health Department’s Ryan White HIV AIDS Legal Project. Prior to her appointment as General Counsel, she served as Assistant Counsel to former Indiana Governor, Frank O’Bannon. She also served as an executive assistant to the Department of Insurance, State Board of Accounts, Utilities and Telecommunications, and the Women’s Commission. Additionally, Keith was Chief Counsel of the Advisory Section under Attorneys General Jeff Modisett and Karen Freeman-Wilson. Prior to her legal career, Keith worked for Eli Lilly and Company in discovery research, environmental and medical plans. She is a member of the American Bar Association’s Health Law Section, and serves on its Council, and is the Interest Group Leader. She also serves on the Board of Directors of the Providence Cristo Rey High School in Indianapolis, Visiting Nurses Service, the State of Indiana Ethics Commission and St. Mary’s Child Center. In addition to earning her J.D. from our law school, she holds an M.S. in Anatomy from Atlanta University, and a B.S. from Spelman College. She is admitted to the Indiana Bar.

Share/Save/Bookmark

ACO Symposium: Professor Jessica Mantel to Present, ACOs: Can we have our cake and eat it too?

Jessica Mantel, Co-Director of the Health Law & Policy Institute, University of Houston, Law Center and Assistant Professor of Law

Jessica Mantel, Co-Director of the Health Law & Policy Institute, University of Houston, Law Center, and Assistant Professor of Law

In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s Seton Hall Law Review Symposium on October 28, 2011, will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs). For more information or to register, click here.

The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. One such distinguished presenter is Jessica Mantel, Co-Director of the Health Law & Policy Institute, University of Houston, Law Center and  Assistant Professor of Law. Professor Mantel will take part in the panel concerned with “ACOs in Theory: Issues Raised by Integrated Delivery,” and will be presenting ACOs: Can we have our cake and eat it too?

Professor Jessica Mantel joined the University of Houston Health Law & Policy Institute as co-director after eight years of service with two government agencies in Washington, D.C. She worked most recently as a senior attorney in the Office of the General Counsel for the Department of Health and Human Services. In that position she advised Centers for Medicare and Medicaid Services on legal issues dealing with Medicare matters, including implementation of the prescription drug benefit, hospital payments, incentive payments for the adoption of electronic health records, and health care reform. She previously worked as a health policy analyst in the Government Accountability Office evaluating Medicare payment issues. Prior to her service with government agencies, she practiced as an associate in the Health Care Department of the firm of Ropes & Gray in Boston and clerked for the Honorable Karen Nelson Moore of the U.S. Court of Appeals for the Sixth Circuit in Cleveland. Her research interests include the impact of various legislative and regulatory schemes on emerging trends in the health care delivery system and the allocation of limited health care resources. In 1997, Mantel received both her J.D. from the University of Michigan Law School and an M.P.P. from the University of Michigan School of Public Policy. She also holds a B.A. in psychology from the University of Pennsylvania.

Share/Save/Bookmark

Recommended Reading: Joan Krause’s “Skilling and the Pursuit of Healthcare Fraud”

October 6, 2011 by Kate Greenwood · Leave a Comment
Filed under: Health Law, Recommended Reading 

kate-greenwood_high-res-2011-compIn her latest article, Skilling and the Pursuit of Healthcare Fraud, which is forthcoming in the University of Miami Law Review, Joan Krause suggests that the Supreme Court’s decision in Skilling v. United States could have a paradoxical effect on health care fraud prosecutions.  In Skilling, the Supreme Court rejected Jeffrey Skilling’s argument that 18 U.S.C. §1346, which criminalizes frauds designed “to deprive another of the intangible right to honest services,” is unconstitutionally vague.  In so doing, the Court strictly cabined the scope of Section 1346, holding that it only applies to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.”  While the Skilling decision is expected to lead to fewer honest services prosecutions overall, Professor Krause believes that it may lead to an increase in honest services prosecutions founded on health care kickbacks.  Professor Krause notes that “bribery or kickback schemes” are activities that “have particular salience in health care.”  She also points out that there are strategic advantages to prosecuting healthcare fraud cases pursuant to Section 1346, including a “focus on the physician-patient relationship as the locus of the misbehavior” that may appeal to juries and the fact that violations of Section 1346 carry longer maximum prison terms than violations of the Anti-Kickback Statute.

In the conclusion to Professor Krause’s article, she acknowledges that “the broader use of the honest services theory in health care kickback cases would raise a host of analytical issues” and then provides a fascinating elaboration.  According to Professor Krause, “the characterization of the physician-patient relationship as a fiduciary one is, perhaps surprisingly, far more complex than first appears.”  The physician is not a typical fiduciary.  For one, the physician’s duty is not all-encompassing — his or her duty of honesty does not extend beyond the provision of medical diagnosis and treatment — and, for another, unlike a traditional fiduciary, a physician has no control over his or her patient’s money.  Moreover, and of central relevance for the prosecution of health care fraud as honest services fraud,  “the physician’s duty to disclose information to patients generally is handled through the state-based law of informed consent rather than through broad federalized notions of fiduciary duty, and few informed consent cases or statutes require the disclosure of financial rather than treatment-related information.”  (For an in-depth discussion of whether disclosure of financial information should be required, see Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy’s December 2010 white paper The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research and June 2011 Journal of Health & Life Sciences Law article An Argument Against Embedding Conflicts of Interest Disclosures in Informed Consent).

If physicians are not legally obligated to disclose financial information to their patients, in what sense do they deprive those patients of their honest services by accepting a kickback?  Professor Krause sets forth a number of possibilities, including (1) that kickbacks are per se deceptive, (2) that kickbacks are deceptive unless proved otherwise, and (3) that “in the absence of a clear duty to disclose a kickback under fiduciary law or informed consent” kickbacks are not deceptive and there can be no honest services prosecution without “additional evidence of harm to the patient — if not tangible harm, at least proof that the physician’s decisionmaking (i.e., the services owed), was in fact influenced in a way that could have affected the patient’s treatment.”  While the third option is arguably “a truer reading of the doctrine,” Professor Krause predicts that it “likely will be found wanting by jurists who believe the disclosure duties imposed under current health law are incomplete.”

I highly recommend Professor Krause’s article for its comprehensive and insightful analysis of the Skilling case’s potential paradoxical effect on health care fraud cases, but also for its thought-provoking concluding section and the numerous timely questions it raises about the relationship between physicians’ duties to their patients and the federal duty to provide honest services.

Share/Save/Bookmark

The significance of yesterday

September 29, 2011 by Brad Joondeph · Leave a Comment
Filed under: Health Law 

brad-joondeph2As the dust begins to settle from all of yesterday’s events, it is probably appropriate–at least in a preliminary sort of way–to take stock of what those events mean. (Howard Bashman at How Appealing gathers commentary from around the web here. And Timothy Jost offers his take here over at Health Affairs. )
None of this is rocket science. But I thought it worth noting the following three developments as particularly significant:

* First and foremost, by asking the Court to grant cert in HHS v. Florida, the Obama administration virtually guaranteed that the Court will take the case and decide it this term–with the argument probably taking place in March, and a decision handed down in June. I cannot think of an occasion in recent history where (a) a lower court has declared a federal statute unconstitutional, (b) that decision created a circuit split, (c) the government asked the Court to grant review, and (d) the Court denied cert–let alone on a question of this magnitude. So the Court’s review is now essentially assured.

* That does not mean, though, that the Court will necessarily reach the merits. As I have written before, one can imagine a collection of five justices, perhaps moved by different motivations, coalescing around a jurisdictional holding that prevents the Court from deciding whether the Act is constitutional. In this respect, it is therefore significant that the government (as revealed in the papers filed yesterday) remains committed to the position it has taken recently in the circuit courts–namely, that the Anti-Injunction Act does not preclude the Court from hearing a pre-enforcement challenge to the minimum coverage provision. Of course, the Court could nevertheless find the AIA bars review; it has a constitutional obligation (under Article III) to assure itself of its subject matter jurisdiction, regardless of what the parties argue. But the fact that the parties are united against such a reading of the AIA makes that result marginally less likely.

* It is interesting–and surprising–that the states (presented as question 2 in their petition) have asked the Court to review whether Garcia v. San Antonio Metropolitan Transit Authority remains good law, or whether it should be reconsidered. Garcia establishes a bedrock principle of contemporary federalism, permitting Congress to subject the states to “generally applicable” regulation–regulation that, more or less, applies to all persons or entities equally. Thus, Congress can regulate state governments as employers (or polluters or proprietors) in the same way it can regulate Microsoft or Google or United Airlines or whomever else. Congress can require all of them to pay a minimum wage, not to dump toxins into rivers, and the like. If the Court were to dislodge Garcia in some way, it would have major ramifications. (I should note here that just because the states have raised this as a question in their petition does not mean that the Court must grant on it. Indeed, the Court could grant the petition and limit its review to questions 1 and 3, or even just question 3, which concerns the individual mandate.)

No doubt, there is more of note to be culled from yesterday’s events. But to me, those are the three most important developments in terms of adding to or altering what we already knew before Wednesday.

We shall soon learn, I would guess, whether the parties plan to file responses to the respective petitions, and whether the Court wants their responses regardless. (The Court generally does not grant a petition for certiorari without having seen a response, but this case is different, with both sides agreeing that cert is justified.) And that will determine the timing of the Court’s grant of review and, in turn, the date of the argument.

In other words–at long last–the real game is just about on.

Response briefs and timing

Some real nitty-gritty on what happens next, and how it affects the timing:

* First, the due dates for certiorari response briefs (or perhaps in opposition) are different, for whatever reason. The United States’s response to the NFIB et al. petition (No. 11-393) is due October 28. The responses of all the plaintiffs to the United States’s petition (No. 11-398) are also due on October 28. But the United States’s response to the state governments’ petition (No. 11-400) is not due until October 31.

* Second, the reason this may be so is that the Solicitor General may well (indeed, is likely to) argue that certioari should be denied with respect to questions 1 and 2 presented in the states’ petition. Again, those questions are:

1. Does Congress exceed its enumerated powers and violate basic principles of federalism when  it coerces States into accepting onerous conditions that  it  could not impose  directly by threatening to withhold all  federal  funding under the single largest grant-in-aid program, or does the limitation on Congress’s spending  power that this Court  recognized in  South Dakota v. Dole, 483 U.S. 203 (1987), no longer apply?

2. May Congress treat States no differently from any other employer when imposing invasive mandates as to the manner in which they provide their own employees with insurance coverage, as suggested by Garcia v. San Antonio Metropolitan Transit Authority, 469 U.S. 528 (1985), or has Garcia’s approach been overtaken by subsequent cases in which this Court has explicitly recognized judicially enforceable limits on Congress’s power to interfere with state sovereignty?

The United States did not address these questions yesterday in its petition for certiorari. Moreover, there is no split of lower court authority on either of them. Thus, the SG has a decent argument that neither of these questions, at least under the Court’s traditional criteria, are certworthy.

* Finally, as the United States is likely to oppose cert at least in part, it makes sense for the Court to wait for all the response briefs to be filed. That means we are looking at, roughly speaking, an order from the Court in late November granting review. And the argument would be in either March or April, with a decision by late June.

[Ed. Note: These posts originally appeared on the aca litigation blog, an invaluable resource in following the various lawsuits pending against the Patient Protection and Affordable Care Act (PPACA or ACA). Bradley W. Joondeph, Professor of Law at Santa Clara Law School, publishes the aca litigation blog.]

Share/Save/Bookmark

Symposium: Implementing the Affordable Care Act: What Role for Accountable Care Organizations?

aco-seton-hall-law-3In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s SETON HALL LAW REVIEW Symposium will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs).

Legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. Luncheon keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers.

Scheduled Panels & Panelists include

Introduction to Accountable Care Organizations

Jorge Lopez (Partner, Akin Gump Strauss Hauer & Feld LLP): Promise and Pitfalls: Health Reform’s Medicare ACO Shared Savings Program

Hal Teitelbaum (CEO and Managing Partner, Crystal Run Healthcare): The Prospect of Being Hanged: Focusing the Physician Mind on ACOs

Michael Kalison (Chairman of Applied Medical Software, Inc.; Of Counsel, McElroy, Deutsch, Mulvaney, & Carpenter): The Lessons of Gainsharing

ACOs in Theory: Issues Raised by Integrated Delivery

Jessica Mantel (Co-Director, Health Law & Policy Institute, University of Houston, Law Center): ACOs: Can we have our cake and eat it too?

Priscilla Keith (Adjunct Professor and Director of Research and Projects, Hall Center for Law and Health, Indiana University School of Law - Indianapolis): The Impact of Accountable Care Organizations on Public Health

Tara Ragone (Research Fellow, Seton Hall Law School): The Role of Competition in Integrated Delivery: ACOs, Federal and State Antitrust Law, and the State Action Doctrine

j_brenner1Keynote

Jeffrey Brenner, M.D., Founder & Executive Director, Camden Coalition of Healthcare Providers

Jeffrey Brenner is a family physician and has practiced in Camden for eleven years as a front-line primary care provider for patients of all ages. Having owned a private practice in Camden, he has experience in implementing electronic health records and running a paperless office, open-access scheduling, as well as first-hand knowledge of the various challenges facing primary care in the current health system.

He currently serves full-time as the Coalition’s Executive Director, where he spends much of his time meeting with stakeholders and policymakers, advocating for the models of care the Coalition has developed and demonstrated through data centric results. Jeff is a faculty member of the Robert Wood Johnson Medical School in Camden and is also a former resident of Camden, having lived in the city for over 8 years. He is a graduate of Vassar College and the Robert Wood Johnson Medical School.

ACOs in Practice: Research on Current Implementation of ACOs

Louise Trubek (Clinical Professor, University of Wisconsin Law School), Barbara Zabawa (Whyte Hirschboeck Dudek, S.C); Felice Borisy-Rudin (University of Wisconsin Law School): Accountable care organizations in two states: A preliminary analysis

Sallie Sanford (Assistant Professor of Law, University of Washington - School of Law & School of Public Health): State-based ACO and Medical Home Pilots: Early Lessons from the Other Washington

John Jacobi (Faculty Director & Dorothea Dix Professor of Health Law & Policy, Seton Hall University School of Law), Lessons from ACO Implementation in New Jersey.

Thomas Greaney (Chester A. Myers Professor of Law and Director, Center for Health Law Studies, Saint Louis University School of Law), Accountable Care Organizations: A New New Thing with Some Old Problems.

law-review-header_31The event will take place at Seton Hall Law School with luncheon served at The Newark Club, One Newark Center, 22nd floor. There is no charge for Seton Hall Law alumni; cost for all others, $25.  Four NJ/NY CLE credits will be available. Visit http://law.shu.edu/lawreviewsymposium to register. For more information regarding the Symposium, please contact Gianna Cricco-Lizza, Symposium Editor, at gianna.criccolizza@student.shu.edu.

Share/Save/Bookmark

Next Page »