Open House - MSJ Program in Health, Science & Technology Law at Seton Hall Law

The next MSJ Open House will be on Saturday, February 25, 2012, from 9 a.m. until 11:30 a.m. (registration begins at 8:30 a.m.). Advanced registration is required. Register here >>

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MSJ Program in Health, Science & Technology Law

Seton Hall Law School offers a Master of Science in Jurisprudence (MSJ) degree in Health, Science & Technology Law. The MSJ program provides professionals working in health care, information technology, telecommunication, pharmaceuticals and biotechnology with a solid foundation in the legal and regulatory aspects of these industries.

The MSJ is unique in that it provides a rigorous grounding in the law for students who do not want to become lawyers, but who, instead, want to use the law to enhance their effectiveness and marketability in a non-legal career. Combining this degree with their professional experiences, MSJ graduates have numerous opportunities available to them. Alumni work in a broad spectrum of positions as compliance officers, contract analysts, healthcare administrators, nurse managers, patent/trademark assistants, pharmaceutical financial analysts, quality assurance managers, supervisors, clinical operations directors, and lobbyists.

The MSJ Open House is an excellent opportunity for prospective applicants to meet and speak with faculty, students and administrators in a half-day long structured program.

The event will include an overview of the MSJ admissions process, the MSJ curriculum and course offerings, a question & answer session with the Director of the MSJ program, two mock classes led by current health law and intellectual property law faculty, information on financial aid, and tours of the law school. A relaxed lunch will allow for time to ask questions of special interest to you.

Please register for the Open House online or by contacting Helen A. Cummings, Administrator of Graduate Programs, at helen.cummings@shu.edu or 973-642-8380. Thank you for your interest in Seton Hall Law School’s MSJ program.

For more information on the MSJ Program as well as FAQs and Admissions criteria, click here.
For more information on the Open House, including a schedule, click here.

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

This 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.

AALS Panel on Teaching Health Law: A Tour de Force

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.

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

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 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.

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

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

In 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.

The significance of yesterday

As 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.]

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

In 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

Keynote

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.

The 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.

Distinguished Guest Practitioner Mark Swearingen Lectures on Trends in Healthcare Law Enforcement

On Wednesday, September 21, 2011, Distinguished Guest Practitioner Mark Swearingen spoke at Seton Hall Law School on a number of healthcare law enforcement topics that were of keen interest to the audience of health lawyers and health lawyers-in-training.  Mr. Swearingen, who graduated from Seton Hall Law in 1998, is a shareholder at Hall, Render, Killian, Heath & Lyman, P.C., a large  healthcare law boutique based in Indianapolis, Indiana.

Among other things, Mr. Swearingen discussed two recent Stark Law cases: United States v. Tuomey Healthcare System, in which a jury award of $49.4 million is currently on review in the Fourth Circuit Court of Appeals, and United States v. Bradford, a summary judgment decision from the Western District of Pennsylvania that also largely favors the government.

As the court in Bradford explains, the case involved two physicians, Kamran Saleh and Peter Vaccaro, who leased a nuclear camera so that they would no longer have to refer their patients to the local hospital, Bradford Regional Medical Center, for nuclear imaging.  Faced with the prospect of losing over a third of its $2,274,094 in annual gross nuclear medicine revenues, the hospital responded by threatening to revoke the doctors’ admitting privileges.  Lengthy negotiations ensued, at the end of which the hospital agreed to sublease the camera from the two physicians; the camera remained at the physicians’ offices but other physicians with privileges at the hospital could use it.

Four local physicians who “provide[d] the same or similar services to patients as Drs. Saleh and Vaccaro” brought a qui tam action alleging that the sublease violated the Anti-Kickback and Stark Acts and that the defendants falsely certified compliance with those laws in connection with claims submitted to Medicare in violation of the False Claims Act.  The court agreed that the defendants violated the Stark Act, because the amounts the hospital paid under the sublease were inflated to account for the referrals the hospital lost as a result of Drs. Saleh and Vaccaro’s decision to lease their own camera.  The court deferred on the Anti-Kickback and False Claims Act charges, because it was unable to conclude at the summary judgment stage that the defendants acted knowingly.

As Mr. Swearingen commented, even if the sublease arrangement in Bradford was, on paper, above approach, the facts leading up to it were not good for BRMC and Drs. Saleh and Vaccaro.  That the hospital responded to losing business to the two physicians by first threatening to revoke their privileges and then entering into a financial arrangement that brought them back into the fold suggests that the sublease was about more than the use of a camera.  The facts in Tuomey were in several key respects similar to those in Bradford.  Tuomey, too, involved a hospital faced with the prospect of a group of physicians performing outpatient procedures elsewhere, which would have meant a loss to the hospital of $6-9 million in annual revenues.  To keep the physicians in the fold, the hospital entered into part-time employment contracts with them.  The government alleged– and the jury presumably found–that the contracts would have been money-losers for the hospital but for the associated facility and other fees that the hospital was able to bill in connection with the physicians’ services.

Mr. Swearingen also highlighted the fact that the hospital in Bradford lost the case despite having obtained an expert opinion that the amount it paid for the camera under the sublease was fair market value.  The defendant hospital in Tuomey similarly lost despite having obtained not one but two valuation analyses and multiple legal opinions.  The hospital in Tuomey relied on an advice of counsel defense and, notably, attorney-client privileged communications were entered into evidence at trial.  Going forward, Mr. Swearingen emphasized, fair market value and legal opinions “will be scrutinized” and “may not be dispositive.”

Yes, the Federal Exchange Can Offer Premium Tax Credits

Whatever else the Affordable Care Act may accomplish, it has provided endless entertainment for law professors. The latest ACA kerfuffle involves the discovery by critics of the ACA of an ACA drafting error that would seem to deprive millions of uninsured Americans of tax credits to purchase health insurance and invalidate regulations recently proposed by HHS and the Treasury Department. The mistake is found in section 1401 of the ACA, which creates a new section 36B of the IRC. Two subsections of 36B ((b)(2)(A) and (c)(2)(A)(i)) suggest that premium tax credit eligibility under the ACA depends on the applicant being enrolled in a qualified health plan “through an Exchange established by the State under section 1311.” This would in turn suggest that individuals enrolled in a qualified health plan through a federal exchange established under section 1321(c) would not be eligible for premium tax credits, contrary to the recent proposed regulations.

That this is a drafting error is obvious to anyone who understands the ACA. Section 1311 of the ACA requests the states to establish American Health Benefit Exchanges and sets out the duties of the exchanges. Section 1321 of the ACA, however, provides that if a state elects not to establish and exchange or fails to do so, HHS must “establish and operate” an exchange in such a state and “take such actions as are necessary to implement” the other requirements of title I of the ACA, which includes section 1401. There is no coherent policy reason why Congress would have refused premium tax credits to the citizens of states that ended up with a federal exchange. None of the CBO reports scoring the ACA suggest that premium tax credits would only be available though 1311 state exchanges and not through 1321 federal exchanges. It is, finally, highly unlikely that the House, whose bill included only a federal exchange, would have approved a bill that only provided tax credits through state exchanges but not through the federal exchange.

No one pretends that the ACA is a model of statutory drafting. The bill, for example, contains three section 1563’s. No one intended the current ACA to become the final law. It was the Senate bill, enacted after the House bill, which was to go through conference before the final ACA was enacted. The election of Scott Brown in Massachusetts, and the adamant refusal of the Republicans to allow the legislation to become law without a supermajority in the Senate, doomed efforts to craft a final bill. Of course, major pieces of legislation are often replete with drafting errors. They are commonly followed by technical correction bills, which are often adopted by unanimous consent. If Congress were functioning as a normal deliberative governing body rather than as the legislative equivalent of trench warfare, errors in the ACA would long ago have been fixed.

But now we seem to be stuck with the textualists delight: a statute whose words clearly say what Congress clearly did not mean.

Is there a way out of this quandary? One possibility is to simply recognize that this is a drafting error. The Supreme Court has occasionally recognized that it is appropriate to exercise common sense in recognizing that “a busy Congress is fully capable of enacting a scrivener’s error into law.” Koons Buick, Pontiac, GMC, Inc. v. Nigh, 543 U.S. 50, 65 (2004) (Stevens concurring). But we do not need to rely on the courts to correct this error. Congress corrected it itself.

Four days after Congress passed the Patient Protection and Affordable Care Act, it enacted the Health Care and Education Reconciliation Act of 2010. Section 1004 of HCERA amended section 36B(f) of the IRC to impose on exchanges established under section 1311(f)(3)—that is, state exchanges—and under section 1321(c)—that is federal exchanges, the obligation to report to the IRS and to the taxpayer information regarding tax credits provided to individuals through the exchange. In this later-adopted legislation amending the earlier-adopted ACA, Congress demonstrated its understanding that federal exchanges would administer premium tax credits.

Section 36B(g) gives the Secretary of the Treasury the responsibility of issuing regulations to implement section 36B. This includes the authority to reconcile ambiguities in the statute, such as the inconsistency between subsections (b), (c), and (f) of 36B. In proposed regulations published on August 17, Treasury has proposed to recognize as eligible for premium tax credits any individual who is enrolled in a qualified health plan through an exchange and who meets other eligibility requirements, and adopts the HHS proposed definition of an exchange, which includes a federally-assisted exchange.

Under the Chevron rule, this official construction of an ambiguous statute should be accorded deference by any reviewing court. In fact, however, there will be no judicial review of this determination. It is not possible to conceive of a person who would be injured in fact by this interpretation of the rule such that they could present a case or controversy under Article III. The possibility, expressed by some, that a state official might be able to challenge the IRS rule should be put to rest by Thursday’s Fourth Circuit ruling, reaffirming long established Supreme Court precedent holding that state officials do not have the authority to serve as “roving constitutional watchdog[s].”

The Changing Landscape of Health Information Regulation

There is an impressive new issue of the American Journal of Law & Medicine out, with top names in the field participating in a symposium entitled “Marketing Health: The Growing Role of Commercial Speech Doctrine in FDA Regulation.”  I also wanted to recommend a piece from Simon Stern and Trudo Lemmens on pharma ghostwriting, which is getting a lot of play in Canada.  Titled “Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles,” the piece could lead to some interesting litigation opportunities.  Here is the abstract:

Ghostwriting and guest authorship of medical journal articles raise serious ethical and legal concerns, bearing on the integrity of medical research and evidence used in legal disputes. Ghostwriting involves undisclosed authorship, usually by medical communications agencies or a pharmaceutical sponsor of the published research; guest authorship involves taking authorial credit for the published work without making a substantial contribution to it. Commentators have objected to these practices because of concerns involving bias in ghostwritten clinical trial reports and review articles. We also note the effects of ghostwritten articles on questions involving the legal admissibility of scientific evidence. Efforts to curb ghostwriting practices, undertaken by medical journals, academic institutions, and professional disciplinary bodies, have thus far had little success and show little promise.These organizations have had difficulty adopting and enforcing effective sanctions, for specific reasons relating to the interests and competencies of each kind of organization.

Because of those shortcomings, a useful deterrent in curbing the practice may be achieved through the imposition of legal liability on the ‘guest authors’ who lend their names to ghostwritten articles. We explore the doctrinal grounds on which such articles might be characterized as fraudulent. A guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO). The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This doctrine has been used by the U.S. Supreme Court to impose sanctions on the authors and corporate sponsors of a ghostwritten article. We discuss the potential penalties associated with each of these varieties of fraud.

This promises to inspire some difficult legal challenges to industry practices that have long been considered undesirable as a policy matter.

Congratulations Jordan Cohen ‘11 and Katherine Freed Matos ‘11

Tonight just a fond farewell and congratulations to two of our finest student bloggers: Jordan Cohen and Katherine Freed Matos, both of whom have graduated from Seton Hall Law, with each receiving  the much vaunted  Health Law Award. They are both now hard at work studying for that fiendish quiz they offer each year at the end of July to see if would be lawyers were paying attention (it is a horrible exercise, I assure you, and if someone you know is studying for the Bar– bring them some food, and leave them alone– they’ll reemerge into the land of the living soon enough). As such, it will be awhile until we hear from them (at least on this blog) again.

After the Bar Exam, Jordan Cohen will be off to employ in the law offices of Brach Eichler, LLC., a preeminent law firm in the New Jersey metro area and a recognized leader in the field of healthcare law.

Katherine Matos has been named to the Office of the Inspector General at the U.S. Department of Health and Human Services, where she will work in the Office of Counsel to the Inspector General, Administrative and Civil Remedies Branch.

You will both be missed. It was a pleasure to work with you, and this blog is better for your having been here. Can’t thank you enough, or wish you enough luck– I expect great things– as it is simply the usual for you both.

Medicaid Cuts and the March Toward a Charity Model of Care

Last week, Nic Terry compiled a list of current threats to Medicaid funding. As he noted then, Medicaid coverage is increasingly becoming meaningless for those seeking specialist care. Though more people are slated to enter the program, policymakers are unlikely to fix these flaws before they arrive. To the contrary, “physician reimbursement will decrease, and hospitals are looking to cross-subsidize some of their Medicaid patient expenditures from the privately insured.” Something to remember next time we hear about how imperative it is to cut public health expenditures: there is an inevitable pressure to “rob Peter to pay Paul.”

The budget drama narrative has so far focused on Republican efforts to further slash (or end) Medicaid, and Democratic resistance. But now even the Obama Administration is showing signs of reverting to form and endorsing a patina of Medicaid coverage without its substance. It is now too scared to even try to assess the full extent of the access problem. Like “death panels” before, the buzzword “spying on doctors” ended a promising program to measure the relative difficulty of getting access to care using different forms of insurance.

Obama officials are also engaged in more troubling substantive capitulations. Consider this CBPP report:

An Obama Administration proposal that’s on the table for budget negotiators would reduce federal Medicaid expenditures by reducing the federal share of Medicaid and CHIP costs, shifting costs to states and likely prompting states to cut payments to health care providers and to scale back the health services that Medicaid covers for low-income children, parents, people with disabilities, and/or senior citizens (including those in nursing homes). . . . The proposal would replace the various matching rates at which the federal government reimburses states for their costs in insuring people through Medicaid and CHIP with a single “blended rate” for each state. A state’s blended rate would be set at a level that provided the state with less federal funding than under current law, thereby saving the federal government money.

Abigail Moncrief has noted that states “are statutorily required—and should be judicially required—to pay a reasonable price for the services they buy” by the Medicaid Act’s equal access provision (42 U.S.C. 1396a(a)(30)(A)). But the Obama Justice Department is apparently complementing the budget team cost cutters by arguing that the Supremacy Clause does not “provide[] a cause of action for an injunction to enforce” the equal access provision. As Steve Vladeck observes, this is “a shift in policy that, if endorsed by the Supreme Court, would make it all-but-impossible to enforce the equal access mandate–one of the most important statutory requirements of the Medicaid program.”

Put it all together, and you have what bloggers Joan McCarter and Digby call a serious reversal for the President:

I don’t think anyone expected the Democratic leadership and the president to walk away from their own hard fought health care reforms before they even had a chance to be implemented. . . . I did think they would have wanted to give their legacy issue a chance to be implemented in full at the beginning, so they could continue to brag about bringing health care to 30 million uninsured Americans if nothing else. . . .But as the president says, in these tough times the government has to tighten its belt just like all American families. I guess he must realize that one of the things American families have had to cut out is their health insurance. So much for that legacy.

Perhaps a “balanced solution” to the budget debate is impossible now. But let’s at least acknowledge where we are heading with the endless Medicaid cost cutting. Much of the developing world has what is essentially a “charity option” for the very poor: they have nowhere near the purchasing power necessary to buy care, but have to rely on the kindness of strangers or NGO’s. We are not imminently headed to that level of catch-as-catch-can care for all of the Medicaid population’s problems: very urgent problems will continue to get attention due to some combination of EMTALA and Medicaid funding. But for many other types of issues, we may need to rely more and more on a combination of cost-shifting and charity. One model is the Global Eye Foundation in India, where “more than 80 percent of the surgeries that the model hospital performs are free of cost to the patient.” When you hear establishment economists talk about increasing the “competitiveness” of the American labor force, and fighting rising health care costs, remember that moving to a developing world model of care is one powerful way of achieving those ends.

Moving the Battle of the Experts to the Hot Tub?

Michael Ricciardelli’s recent post concerning a judge-directed negotiation pilot program in the Bronx to facilitate early resolution of medical malpractice cases reminded me of another idea to improve our expensive, expert-deadlocked, malpractice litigation system: hot tubbing.

I first heard this term (related to litigation, that is) earlier this Spring when a former colleague shared an article by Bryan Finlay QC, head of the litigation practice at WeirFoulds LLP in Canada, and law student, Kristi Collins, that discusses hot tubbing as an example of a new tool for judges to use in managing evidence in complex litigation.  According to this article, hot tubbing, also less colorfully referred to as concurrent evidence, refers to “a method of presenting expert evidence all at once by having the expert witnesses for both parties give testimony, answer questions, and fully discuss the expert evidence on one panel.” Finlay and Collins report that this practice originated in Australia in recent years and is gaining attention in Canada, the United Kingdom, and the United States.

Honorable Justice Peter McClellan, Chief Judge at Common Law, Supreme Court of New South Wales, Australia, describes the concurrent evidence process in a 2010 article in the Journal of Court Innovation:

Concurrent evidence is essentially a discussion chaired by the judge in which the various experts, the parties, the advocates and the judge engage in a cooperative endeavor to identify the issues and arrive where possible at a common resolution of them. Where resolution of issues is not possible, a structured discussion, with the judge as chairperson, allows the experts to give their opinions without the constraints of the adversarial process and in a forum which enables them to respond directly to each other. The judge is not confined to the opinion of one advisor but has the benefit of multiple advisors who are rigorously examined in public.

* * *

[Concurrent evidence] requires the experts retained by the parties to prepare a written report in the conventional fashion. The reports are exchanged and, as is now the case in many Australian courts, the experts are required to meet without the parties or their representatives to discuss those reports. . . .  The experts are required to prepare a bullet-point document incorporating a summary of the matters upon which they agree, but, more significantly, matters upon which they disagree. The experts are sworn together and, using the summary of matters upon which they disagree, the judge settles an agenda with counsel for a “directed” discussion, chaired by the judge, of the issues in disagreement. The process provides an opportunity for each expert to place his or her view on a particular issue or sub-issue before the court. The experts are encouraged to ask and answer questions of each other. The advocates also may ask questions during the course of the discussion to ensure that an expert’s opinion is fully articulated and tested against a contrary opinion. At the end of the discussion, the judge will ask a general question to ensure that all of the experts have had the opportunity to fully explain their positions.

(To see how hot tubbing works in trials in Australia, you can watch a video narrated by Justice McClellan here.)

Finlay and Collins report that “[e]xperts tend to like the hot-tubbing method.”  As they explain, “[t]he procedure allows them to more fully flesh-out and discuss their positions in, at least the beginning, a less adversarial way.  They like the opportunity to pose questions to each other.”  Justice McClellan agrees, reporting that “[t]he change in procedure has been met with overwhelming support from the experts and their professional organizations.”  This can lead to a more collegial and less partisan and adversarial exchange among professional colleagues.  This process may also reduce the likelihood that experts will take extreme positions, knowing that a colleague stands ready to challenge the basis for their statement.

Justice McClellan also relayed that “[a]lthough counsel may be hesitant about the process initially, [he has] heard little criticism once they have experienced it.”

Finders of fact, too, seem to like what hot tubbing offers.  Justice McClellan, who has presided over numerous hot tubs, is an unabashed proponent:

From the decision-maker’s perspective, the opportunity to observe the experts in conversation with each other about the matter, together with the ability to ask and answer each others’ questions, greatly enhances the capacity of the judge to decide which expert to accept. Rather than have a person’s expertise translated or colored by the skill of the advocate, and as we know the impact of the advocate can be significant, the experts can express their views in their own words. There also are benefits which aid in the decision-writing process. Concurrent evidence allows for a well-organized transcript because each expert answers the same question at the same point in the proceeding.

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Contractual Liability and Clinical Trial Reimbursement in Italy

Contractual Liability and Clinical Trial Reimbursement in Italy

By: Christopher J. Asakiewicz, Esq. and Anna Pinkhas, Esq. [1]

In the Italian Ministerial Decree of July 14, 2009 (the “Decree”) the Ministry of Labour, Health and Social Policy sets forth a number of statutory requirements relating to insurance in human clinical trials conducted in Italy. In order to safeguard the clinical participants the Decree expanded on and formulized into law a requirement previously established by the European Union, which provides that a clinical trial can be initiated in the Member States only when provisions have been made for insurance or indemnity to cover the liability of the investigator and sponsor towards clinical trials subjects. [2] However prudent and protective of clinical participants the Decree is, its implementation into Italian law has led to significant delays in the negotiation of the indemnification clauses in clinical trial agreements because of improper interpretation, an interpretation that delays the introduction of possible life saving medicines into the country and the European marketplace.

Indemnification is a critical part of the clinical trial agreements between clinical trial sponsors, investigational sites and, sometimes, the principal investigator. Generally, indemnification language in any agreement seeks to impute liability to a contractual party for acts or omissions and to defend, hold harmless and compensate the other party for any loss that such party may suffer during the performance of the contract that results from said acts or omissions. Indemnification provisions in a clinical trial agreement differ among varying sponsors and investigational sites. Generally, the provisions are mutual. A mutual indemnification provision will have the sponsor indemnify for personal injury or illness to study patients that relates to the study or the study drug, and likewise, the other party will indemnify the sponsor for any negligence or willful misconduct for which it is responsible.

Drafting and negotiating an indemnification clause can be both difficult and tedious, as the clause’s meaning is particularly important during litigation. Frequent confusion, however, between indemnification and study subject reimbursement further complicates and delays negotiations. A clinical trial agreement generally also includes a provision where the sponsor agrees to reimburse the institution for any reasonable and necessary medical expenses incurred by the investigational site for the treatment of patients’ illness or injuries related to the study or the study drug.  The purpose of such subject injury language is to address reimbursement of expenses incurred to treat an adverse event. [3] This reimbursement language is meant to swiftly compensate such injuries without regard for party fault so the patient can receive care immediately or continue to receive the highest standard of care.

Indemnification, on the other hand, is to assume responsibility and the costs incurred in litigation or from claims that resulted from the fault attributable to the wrongdoing of the indemnifying party. Although these two scenarios are clearly distinguishable, confusion arises over the Italian regulation because of misunderstanding about the nuances of indemnification as compared to subject injury reimbursement. The Decree states that the promoter, or the sponsor, of the clinical trial shall provide insurance to cover “any civil liability of investigator and promotor of the clinical trial, without excluding any damage which may be unintentionally caused by accident e/o be attributed to negligence, imprudence or inexperience.” [4] In other words, the clinical trial sponsor is required by the Decree to be insured to sufficient limits for not only willful or reckless conduct, but also for negligent unintentional acts or omissions. [5] Many Italian sites interpret this language to mean they are not responsible for their own negligence and therefore remove their indemnification obligation of the sponsor, the promotor, from the clinical trial agreements. However, the Decree only governs reimbursement to study subjects by the insured in the event of injuries, and does not limit contribution as well as the investigational site’s indemnity of the sponsor for those third party claims which fault is attributable to either it or its actors.

Article 1 states: “The insurance policy is to grant specific cover in connection with the reimbursement of damages caused to the subjects by the clinical trial activities throughout the entire duration thereof.”

[6] The Decree’s purpose is therefore not to forgive or excuse liability, but only to safeguard participants by ensuring that a damaged party obtains reimbursement immediately. It is incorrect to interpret the legislation’s purpose as being a limit on the scope of the Institution’s liability with respect to its own actions, as the Decree further states “[t]his restriction shall not in any event impair the right of the damaged party to seek reimbursement of damages from the person liable therefor.” [7] Exclusion language which relates to negligence, imprudence or inexperience of the investigator serves to make the insurance policy a no-fault policy, assuring participants appropriate compensation and reimbursement for their injuries or illness without having to litigate the cause of the injury or prove fault. [8]

The patient’s clinical trial injury and treatment expenses will be immediately reimbursed by the policy. But, as the Decree does not limit the remedies at law, and corresponding insurance policy’s only purpose is to compensate the participant immediately, the site can still be held liable by a court for its actions. In the situation, when the sponsor was required to compensate, but is not the determined cause, the sponsor is entitled seek contribution or indemnity for such actions’ expenses from those actors responsible. The Italian Civil Code also supports the notion that the site can still be held liable, as Article 2053 provides that any willful or negligent conduct, causing an unjust harm to third parties, obliges the tortfeasor to compensate the damages. [9]

To resolve this confusion between indemnification and clinical trial injury reimbursement, the authors recommend that a sponsor with sites operating in Italy, (i) obtain an insurance policy covering all treatment expenses incurred by patients and associated with injuries related to the study drug or protocol procedures, and (ii) ensure that any indemnification provision in the clinical trial site’s contract does not exclude the institution or the investigators from liability. The Italian Civil Code and Decree are both in agreement that those persons liable for causing harm to a third party are obligated to compensate for those damages. The sponsor through clinical trial insurance can therefore immediately reimburse the patient’s costs, then, in accordance with the mutual indemnification, the sponsor or the insurer may seek to subrogate or recoup through contribution such expenses which are attributable to the investigational site or investigator and outside the sponsor’s control. [10]

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[1] DISCLAIMER: Both authors are admitted to practice law in the state of New Jersey and draft and negotiate international clinical agreements as well as counsel on patient disclosures for pharmaceutical companies. The views and opinions expressed are solely those of the authors and shall not be attributed to any other party, company or entity. The expressed opinions are for informational purposes only, and not meant to nor intended to be an advertisement, solicitation, legal advice, authority nor services of any kind to any Client, including any person or entity in any state, country or sovereign nation. Such information is not meant to create an attorney-client relationship. the reader must not act nor rely upon these materials without seeking professional legal counsel.

[2] See Art. 3(2)(f) Directive 2001/20, of the European Parliament and of the Council of  4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, 2001 O.J. (L 121) 34, 37 ( “provision has been made for insurance or indemnity to cover the liability of the investigator and sponsor. “); See also Art. 3(1)(f) Decreto Legislativo, 24 June 2003, n. 211, G.U. 09 Aug 2003 (It.) (”provision has been made by the trial sponsor for insurance to cover the third-party liability of the investigator and the sponsors in the event of claims for damages by trial subjects.”).

[3] “adverse event” means any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

[4] Art. 1(2) Decreto Ministeriale 14 July 2009, n. 213, G.U. 14 September 2009 (It.) (Italian Ministerial Decree, Minimum requirements for insurance policies which safeguard participants to clinical trials of medicinal products.).

[5] See Art. 2(2) D.M. n. 213/2009 (It.) (”Insurance shall provide for an insured limit for the reimbursement of damages not lower than Euro 1 million per participant, although the following minimum limits for each individual protocol are required, not less than: a) Euro 5 million if trial participants are less than or equal to 50; b) Euro 7 million five hundred thousand if the trial participants are more than 50 but less than 200; c) Euro 10 million if the trial participants are more than 200.”).

[6] Art. 1(2) D.M. n. 213/2009 (It.) (emphasis added).

[7] Art. 1(6) D.M. n. 213/2009 (It.) (emphasis added).

[8] “no-fault insurance” is any type of insurance contract under which insured’s are compensated for losses, regardless of fault in the incident generating said losses.

[9] Art. 2043 Codice civile [C.c.] (It.) (Italian Civil Code).

[10] See Blacks Law Dictionary (9^th ed. 2009) (1) (SUBROGATION “1. The substitution of one party for another whose debt the party pays, entitling the paying party to rights, remedies, or securities that would otherwise belong to the debtor.”).

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