A Case to Watch: Heimeshoff v. Hartford Life & Accident Ins. Co.

By Jeremy Kreisberg

A little over two weeks ago, the Supreme Court heard oral argument in a rather obscure ERISA case—Heimsehoff v. Hartford Life & Accident Ins. Co.  The case asks a rather basic question without a readily apparent answer: when a beneficiary of an ERISA-regulated insurance plan seeks to claim benefits, may the statute of limitations period for judicial review of the benefit decision begin before the completion of the plan’s mandatory internal resolution process?  In other words, can a statute of limitations for judicial review begin to run before a beneficiary is permitted to file suit?

The problem this lawsuit seeks to address can be clarified through a hypothetical: Imagine beneficiary B has an ERISA-regulated disability insurance plan with (i.e. provided by her employer but issued and administered by) insurer I.  B’s contract with I states that a three-year statute of limitations for judicial review of benefit decisions begins running at the date that B sends I proof of loss.  Then the following takes place:

  • B sends I her proof of loss on January 1, 2010.
  • I’s internal resolution process is completed on January 2, 2013, and B is denied her claim.
  • B believes the decision was erroneous and seeks to challenge it in court.
  • The court informs B that she has no claim because the statute of limitations—three years from January 1, 2010, the date that B sent I her proof of loss—has run.

B’s case certainly seems rather compelling.  After all, I has functionally denied B any opportunity to receive independent review of I’s benefit decision.  But at oral argument, the Justices raised several interesting arguments that make the outcome of this case far from clear.

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11/21: Neil Flanzraich on “Responsibility and Integrity in the Pharmaceutical Industry”

Please join the Petrie-Flom Center for a lecture by Neil Flanzraich on responsible pricing strategy, access to care, clinical trial design, outsourcing, and other topics that raise thorny but crucial issues for pharmaceutical and biotechnology companies.  There will be substantial time for Q&A.

Mr. Flanzraich graduated from HLS in 1968, and was appointed by Dean Martha Minow as an Expert in Residence at the Harvard Innovation Lab (i-lab) in fall 2012. He is the Executive Chairman of Kirax Corporation and the Executive Chairman of ParinGenix, Inc., both of which are privately owned biotech companies. He previously served as the Vice Chairman and President of Ivax Corporation, an international pharmaceutical company, which was sold to Teva in 2006 for an enterprise value of $10 billion.

For more information, please visit our website.

Toward an Epidemiological Definition of Community

By Nathaniel Counts

With the coordination and additional funding afforded by the National Prevention, Health Promotion, and Public Health Council and the Prevention and Public Health Fund under the Affordable Care Act, scholars may have a unique opportunity to work toward an epidemiological definition of community.  The evaluation and record-keeping components of the different interventions will inevitably lead to a great deal of additional information about individuals, including their beliefs, behaviors, and health, over time.  If one’s behaviors, and in particular the Leading Health Indicators (ten factors chosen by Health and Human Services that contribute to health, including substance abuse, exercise levels, condom use, etc.) and health status are determined in part by social signaling, it may be possible to use this data to determine which individuals seem to be part of a community.  Various environmental, and possibly even genetic, factors could be controlled for to find groups of individuals whose Leading Health Indicators affect one another’s, and whose health statuses are linked.  This grouping would be a functional “community,” a group of people who influence one another, whether they realize it or not. Currently, the notion of community is usually defined geographically – your community are those that are close to you, unless it is a city, in which case your community are those who are nearby of similar socioeconomic class.  This method would allow for greater precision in determining groups that influence another.

A more precise understanding of community would be useful for assessing the impact of interventions, public health or otherwise.  If you can see the initial community structures at the beginning of an intervention, you could target the individual communities for change and see how their Leading Health Indicators and health statuses evolve.  You could also, and more importantly, see how an intervention changes the make-up of a community.  A new basketball program in a local gymnasium will bring together different arrangements of individuals, who may in turn influence one another, joining them into a community and linking their health statuses.  This could determine choices of programs – a youth basketball league will shape communities differently than a family program or an adult program, and conscious choices could be made about how to bin people based on their current risk behaviors.  This type of information could also provide caution to those planning any sort of intervention – any interaction could reshape communities, subtly changing individual’s values and even their health in ways unbeknownst to them and unintended by the intervener.

HHIP: Friday, November 8: Peter Singer – Effective Altruism

Harvard High Impact Philanthropy presents:

Peter Singer on Effective Altruism

Effective altruism is a new movement consisting of many individuals and several independent organizations, all focused on the deceptively simple idea that we should try to do as much good as we can. The existence of this movement raises many interesting questions, both practical and philosophical, which this talk will discuss.

Friday, November 8th; 4 – 5 PM, in Science Center D

RSVP to the event

Peter Singer is the Ira W. DeCamp Professor of Bioethics at the Princeton University Center for Human Values and Laureate Professor at the Center for Applied Philosophy and Public Ethics at the University of Melbourne. He is well known for his philosophical work, as well as for his books – most recently including The Life You Can Save.
This event is co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Oswald DeN. Cammann Fund, as well as Harvard’s Departments of Economics and Philosophy.

Prof. Singer will also speak on “Ethics and Animals: Where Are We Now?” at 12 PM in Austin 200 (Ames Courtroom), 1515 Massachusetts Ave.

 

Skype co-founder Jaan Tallinn highlights X-risk

By Nir Eyal

Young people often assume that their life expectancies will remain what life expectancy is today—although life expectancy will grow by the time they are old. When all of us imagine our futures, we often neglect to take account of radical technologies which were not foreseeable prior to their invention, just as the internet wasn’t, and instead imagine something closer to present realities. We do not appreciate how different the future could be.

Among other things, the future might be dangerous to humankind in ways that we fail currently to appreciate. We got lucky, and nuclear energy seems hard for individuals to develop at home, but will that last, and will new WMDs be impossible to replicate with 3D printers or other future technologies? Can anyone guarantee that viruses manufactured for scientific research will not be spread by error or terror? Can we guarantee that robots designed for contained military purposes would not go out of control? Or that once artificial intelligence is advanced enough to design other artificial intelligence, humans will remain safe for long? Some of the greatest dangers to our species are unknown, simply because the technologies that create them have not been invented yet—just as many technologies that exist and threaten us today were not invented 100 years ago.

In a multimedia presentation that drew a prolonged applause from a crowd of Harvard undergraduates, Estonian programmer Jaan Tallin wove together three stories: the story of Kazaa and Skype, which he helped start; his personal journey into studying and promoting the study of existential risk; and a “sermon” (as he put it, tongue in cheek) on the ethical responsibilities of technology developers.

Tallin proposed taking active steps in anticipation of our future errors, both to make businesses robust and to keep our species safe in an opaque future: incorporating safety margins, and continually questioning one’s assumptions. He concluded by arguing, provocatively, that indispensable to both goals is having fun.

The talk was organized by the student organization Harvard High Impact Philanthropy (HHIP).

Announcing the New Journal of Law and Biosciences

The Petrie-Flom Center and Harvard Law School are delighted to announce our partnership with Duke University, Stanford University, and Oxford University Press to launch a new peer-reviewed, open access, online journal in 2014: Journal of Law and the Biosciences (JLB).

JLB will become the preeminent outlet to publish cutting-edge scholarship wherever law and the biosciences intersect. The journal will take a broad and interdisciplinary view of these areas, publishing articles on topics generally considered part of bioethics or neuroethics, such as the ethical, legal, and social implications of reproductive technologies, genetics, stem cell research, neuroscience, or human biological enhancement.  At the same time, JLB will be a home for work that speaks directly to legal issues where the biosciences can be involved, such as food and drug regulation, biosciences patent law, scientific evidence, and criminal responsibility.

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GIM: Informed consent for return of incidental findings in genomic research

By Nicholson Price

In the second installment of our new collaboration with Genetics in Medicine, we are highlighting an article released last week discussing informed consent for the return of incidental findings in genomic research.

As whole-genome and whole-exome sequencing become increasingly common in medical research, the potential grows for identifying genetic findings that are unrelated to the main focus of the study (often called “incidental findings,” or “IFs”).  There is substantial debate about the duties associated with incidental findings, including whether researchers should or must search for them under ethical or legal frameworks, and whether and how to return the results to research participants.  One understudied aspect of the issue, though, is how informed consent should be obtained for the return of such findings, and this paper begins the task of addressing that question. Continue reading

Georgia’s Medical-Malpractice Reform Bill

By Alex Stein

Georgia’s Senate is considering a far-reaching medical malpractice reform: see here. If implemented, this reform would substitute the conventional malpractice regime by a no-fault compensation scheme for patients sustaining medical injuries. This scheme will be modeled on the extant workers’ compensation regime. An injured patient will submit her claim to a special administrative tribunal—the Patient Compensation Board—that will determine her eligibility for compensation promptly and expediently.

Will this reform succeed? Continue reading

Action of Ohio Controlling Board on Medicaid Expansion

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

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

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

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

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Disruptive Innovation and the Rise of the Retail Clinic

By Michael Young

The Association of American Medical Colleges (AAMC) projects that by 2025 the United States will face a shortage of 130,600 physicians, representing a near 18-fold increase from the deficit of 7,400 physicians in 2008.  The widening gap between physician supply and demand has grown out of a complex interplay of legal, political, and social factors, including a progressively aging population, Congressionally mandated caps on the number of Medicare-funded residency slots and funding for graduate medical education, and waning interest among medical school graduates in pursuing careers in primary care.

These issues generate unprecedented opportunities for healthcare innovators and entrepreneurs to design solutions that can effectively address widening disparities between healthcare supply and demand, particularly within vulnerable and underserved areas.

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Petrie-Flom Intern’s Weekly Round-Up: 10/19-10/25

By Fatima Mirza

Kaiser v. Pfizer and the Question of Who Pays When Fraudulent Pharmaceutical Promotion Has Its Intended Effect

By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion.  The decisions were noteworthy because in them the First Circuit lent its imprimatur to a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid.  In the lead case, brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, the  appellate court upheld a jury verdict that, after trebling, came to $142 million.

Not surprisingly, Pfizer has petitioned for certiorari, arguing that the First Circuit’s decisions “warrant review because they…raise important and recurring questions concerning the proper test for proximate cause under RICO and the permissibility of aggregate statistical proof in collective fraud cases.”  Amici briefs filed by BIO, PhRMA, and the Washington Legal Foundation echo these arguments, leaning heavily on the spectre of a “staggering” increase in suits founded on “pharmaceutical companies’ alleged off-label promotion.”  In addition to the financial burden posed by the “likely surge”, amici argue that it would chill their “truthful and constitutionally protected speech concerning beneficial off-label uses of FDA-approved drugs.”

Civil RICO claims cannot be predicated on “off-label promotion”, however.  To state a claim, a plaintiff has to allege that the defendant pharmaceutical company engaged in one of the predicate acts enumerated in the RICO statute, typically mail or wire fraud.  In this case, the jury found that Pfizer promoted the anti-seizure drug Neurontin as a safe and effective treatment for indications for which Pfizer knew it was no more effective than a placebo.  On appeal, Pfizer did not contest the jury’s finding that it committed fraud.  This distinguishes this case from those decided by other circuits and suggests that the First Circuit’s decisions may not open the floodgates quite as wide as Pfizer and its amici claim.

There is also reason to question the claim that the First Circuit adopted a new, more “relaxed” standard of causation in the case. Continue reading