Classifying Ebola as a National Security Threat

At yesterday’s Third Annual Health Law Year in P/Review event hosted by the Petrie-Flom Center, George Annas, William Fairfield Warren Distinguished Professor of Health Law, Bioethics, and Human Rights at Boston University School of Public Health, discussed the legal and public health response to Ebola. One issue that he raised was that in response to the outbreak in West Africa, President Obama classified the situation as a matter of national security rather than a public health issue. It is not clear to me that these categories need be mutually exclusive. (To be clear, Annas did not assert that they were.) Regardless, retrospectively the decision to frame Ebola as a threat to national security appears to have allowed bi-partisan support for a large scale humanitarian aid project, in a way that alternative framing of the problem may not have. It is interesting to note that the President actively encouraged the Ebola outbreak to be perceived as a “biological danger,” a “national security threat,” and “not just a humanitarian or economic concern.” However, framing the Ebola outbreak in West Africa as a national security issue did not only come with the positive externality of increased support for foreign aid. Once a domestic issue, there was some confusion as to who was “in charge” of the handful of Ebola-related issues that arose–with the President appointing an Ebloa Czar, Gov. Christie issuing quarantine notice for Kaci Hickox, and the response of the CDC blaming the nurses for breaking protocol the Dallas hospital case, serving just a few main examples.

Although framing Ebola as a national security issue may have allowed for increased support for the United States’ role internationally, it is unclear whether the domestic response to Ebola could have been more coordinated had this initially been framed as a public health issue.

German Supreme Court: Children of Any Age Have Right to Access the Identity of Their Anonymous Sperm Donor

The German Supreme Court ruled on Wednesday that children of any age (one of the children in this case was 12!) had the right to access the identifying information of their anonymous sperm donor, a major step towards ending sperm donor anonymity in the country. The court rejected the notion of a minimum age on behalf of children, but did require that it be shown that the child requested the information. News reports also suggested that the court indicated that “the private life of the donor must be taken into account,” but not reading German I can’t confirm what the Court meant in this regard (though I suspect the Court was being itself somewhat vague and uncertain). It has been estimated that there are currently 100,000 German citizens fathered by sperm donors with an additional 1,500 to 5,000 born each year.

There is a definite trend in rejecting sperm donor anonymity across the world that continues to gain steam. For reasons I have expounded elsewhere, I think the argument for ending anonymity, and its reliance on best interests of the resulting child reasoning, is problematic. But in other work I have also examined whether increasing compensation for sperm donation may increase the number of men willing to be non-anonymous donors.

(H/T Pablo De Lora)

 

“Volume to Value” Still Needs an Ethics Consult

By Kelsey Berry

Whereas “allocation of scarce resources” is a buzz phrase that inspires a great deal of distress and desire for good ethical argument, “waste avoidance” strikes us as a relatively uncontroversial method for containing health care spending. Perhaps this is because rationing implies a trade-off between two individuals, each of whom have the potential to benefit from a possible intervention, whereas waste avoidance, on the other hand, implies a trade-off between two services – one of which has the capacity to benefit an individual, and the other which does not. Surely the latter trade-off is preferable, and perhaps even imperative, to make before we take up the former. This week U.S. Secretary of Health and Human Services Sylvia Burwell signaled a commitment to making the latter trade-off in her announcement on a complex area of health care financing: Medicare payment & payment reform. Medicare payment is one of the few levers that the federal government has relatively direct control over when it comes to controlling health care spending, and Burwell’s announcement was a welcome change in the policy discourse from the oft-lamented “doc fix”/SGR debacle (a fix for which was just bypassed again).

In her announcement and this perspectives piece in NEJM, Burwell set goals to (1) move 50% of Medicare payments to alternative payment models such as Alternative Care Organizations (ACOs) and bundled payment arrangements by 2018, and (2) tie 90% of all Medicare payments made under the traditional fee-for-service model to quality or value, through programs such as the Hospital Value Based Purchasing and the Hospital Readmissions Reduction Programs, by 2018. Notably, these are the first explicit goals for transitioning to alternative payment models and value-based payments that have been set in the history of the Medicare program – though it remains to be seen how these goals will be pursued.

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Professionalism in Medicine

By Deborah Cho

As an update to my previous post here on medical students and professionalism, Judge Sutton writing for the Sixth Circuit found that a medical school could deny a degree to a medical student for failing to meet “professionalism” requirements.  According to the opinion, the medical student had come late to classroom sessions, allegedly behaved inappropriately at a formal dance, had to repeat his internal medicine rotation due to poor performance, and had been convicted of driving white intoxicated.  The Sixth Circuit found that Ohio, where the medical school is located, treats the relationship between a university and a student as contractual in nature, with that contract’s terms supplied by the student handbook.  As the handbook in this case included professionalism as part of the academic curriculum, the university’s determination that the student failed to meet professionalism requirements was an academic judgment and thus merited deference by the court.

Last summer, Judge Gwin of the Northern District of Ohio found that the medical school went beyond its scope of duty by extending its determination of professionalism well past academic or patient related matters.  The district court found for the student, noting that the “character judgments” found by the university were “only distantly related to medical education.”  In my last post, I noted that this separation of personal character from competence to practice medicine seemed troublesome.  The Sixth Circuit’s opinion reversing the district court shows similar concerns.

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Monday 2/2: HLS Health Law Workshop with Thomas Greaney

HLS Health Law Workshop: Thomas Greaney

February 2, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the paper: “Medicare Advantage, Accountable Care Organizations, and Traditional Medicare: Synchronization or Collision?”

Thomas L. Greaney is Chester A. Myers Professor of Law and Co-Director of the Center for Health Law Studies at St. Louis University School of Law. Greaney joined the faculty at SLU LAW in 1987 after completing two fellowships and a visiting professorship at Yale Law School. He became Chester A. Myers Professor of Law in 2004 and was named Health Law Teacher of the Year by the American Society of Law, Medicine and Ethics in 2007. His academic writing has been recognized six times by the Thompson Coburn Award for SLU Faculty scholarship.

Greaney’s extensive body of scholarly writing on health care and antitrust laws encompasses articles published in some of the country’s most prestigious legal and health policy journals. He has authored or co-authored several books, including the leading health care casebook, Health Law. A frequent speaker in academia and the media, Greaney has also offered expert testimony at hearings sponsored by the Federal Trade Commission on the issues of applying competition law and policy to health care, and submitted invited testimony to the U.S. Senate on competition policy and health care reform.

Nonprofit Hospitals Sue Patients, and New IRS Rules Offer Limited Protection

[Cross-posted from the Center for Law, Health and Society Blog at Georgia State University]

By Guest Contributor Erin C. Fuse Brown

Last month, NPR and ProPublica reported a story that would be shocking if it weren’t sadly familiar about how nonprofit hospitals like Heartland Regional Medical Center in Missouri are suing their patients and garnishing their wages for unpaid bills.  A few days later, on December 31, 2014, the IRS issued final rules for tax-exempt hospitals that ostensibly will make these practices more difficult, if not illegal.

The IRS rules implement the requirements of Section 501(r) of the Internal Revenue Code added by the Affordable Care Act in 2010. Despite characterizations that these are “sweeping new rules” that protect financially vulnerable patients from excessive charges and aggressive debt collection by nonprofit hospitals, the rules provide fairly thin and spotty levels of protection for patients. Continue reading

Gates Annual Letter: Where’s the policy?

In recognition of how little we talk about global health, I am turning my attention back to my roots for today’s post.

On Jan 22nd, Bill and Melinda Gates launched their annual letter. For those readers who live fully under a domestic health policy rock, Bill and Melinda Gates are co-chairs of the Bill and Melinda Gates Foundation, which donated more than $1 billion in 2013 to global health activities. Aside from that enormous sum, the foundation is commonly looked upon as an example of what strategic philanthropy can do.

The 2015 Annual Letter, launched on January 22nd, resembles previous letters insomuch as it strikes an optimistic tone about the progress made to date and makes bold claims about the future impact of the foundation. Specifically, the Gates’ tell us that they are aiming to have impact in four areas in the next 15 years – health, farming, banking and education. In the area of health, the letter specifies a focus on several specific projects, including cutting the number of children who die before 5, reducing the number of women who die in childbirth, wiping polio and three other diseases out entirely, finding the secret to the destruction of malaria and forcing HIV to a tipping point.

For our purposes, what’s most interesting about the letter is what it doesn’t say. It makes no mention of law or policy and makes only passing reference to regulation and governance. What is this about?

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Measles Can Kill, And It’s Spreading. Sue Parents Who Didn’t Vaccinate? Absolutely.

A new piece in Forbes on suing parents who don’t vaccinate, by Dan Diamond:

I heard it over dinner at a friend’s house. I talked about it on a call with a scientist. I discussed it while waiting for public health officials to issue an update on the measles outbreak.

The same murmured question, the same growing fear.

What happens if a child dies because some parents decided not to vaccinate their own kid?

What happens if it’s my child?

Thankfully, it’s still a hypothetical. But there’s reason to worry: More than 100 people in six states are now sick with the measles, in an outbreak that can be traced directly back to Disneyland. Dozens of newborns have been put into isolation.

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Tomorrow: 3rd Annual Health Law Year in P/Review

P-Review_2015_poster_with_borderJanuary 30, 2015 7:45 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Health Care Policy by Common Sense?

By David Orentlicher

[Cross-posted at HealthLawProfs]

In announcing the federal government’s approval of Indiana’s Medicaid expansion, Governor Mike Pence invoked common sense in defending his insistence that beneficiaries shoulder a share of their health care premiums. According to Pence, “It’s just common sense that when people take greater ownership of their health care, they make better choices.”

But relying on common sense is not a good way to make health policy. Common sense leads people to incorrectly believe that they are more likely to catch a cold by going out in cold weather or to take megadoses of vitamins that provide no additional health benefit and can be toxic. Common sense also leads physicians down the wrong path. Because lowering blood sugar has been good for the health of diabetics, medical experts recommended tight control of blood sugar levels. But that resulted in an increased risk of death for many patients. Continue reading

Tomorrow (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

Death Spirals…to the Rescue!

We’ve heard a lot about “death spirals” and how they could stand in the way of the Affordable Care Act’s goal of a functioning individual health insurance marketplace.  Seth Chandler has an interesting blog devoted to the subject, “ACA Death Spiral.”  And those who have been following King v. Burwell, the Supreme Court’s latest ACA case, have been predicting that a ruling against the government there would be disastrous because it would only exacerbate the “death spiral” threat to individual health insurance markets.  (See a sum-up of such predictions here.)

But could death spirals save the ACA?  According to a fascinating amicus brief filed in the King case by a number of interest groups and co-signed by several prominent law professors and Bill of Health contributors (I understand that Abigail Moncrieff is the driving force behind the brief, joined by Allison Hoffman, Sharona Hoffman, Russell Korobkin, Joan Krause, Stephen Marks,  Kevin Outterson, and Theodore Ruger), the answer might be yes.  The argument boils down to “death spirals to the rescue.”  (Here is a copy: 14-114 bsac JALSA.)

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Global Health Impact and Access to Essential Medicines

By Nicole Hassoun, The Global Health Impact Project

Ebola is ravaging parts of Africa, yet it is not the worst health problem facing people in the region. Millions more are infected with and die every year from diseases like malaria, TB, and HIV/AIDS because they cannot access the essential medicines they need. To change this, we need to understand where we are succeeding in combating these diseases, and where we need to focus our efforts. Until now, this information has been sorely lacking.

Fortunately, the beta for a new Global Health Impact index has just launched that can help us address the access to medicines problem (check out: global-health-impact.org). Using the index, you can see the impact of the drugs for HIV, malaria, and TB in each country in the world. You can also get a sense for the overall impact we are having on the different diseases in the model. Finally, one can see drugs’ impacts by originator company. Continue reading

Are Egg Donors like Miners and Boxers?

By Dov Fox

The U.S. tax court has just issued its long-awaited decision in Perez v. Commissioner, 144 T.C. No. 4 (Jan. 22, 2015). (Hat tip to Richard Carpenter, who represented Perez.) The case decided whether the $20,000 a woman called Nichelle Perez received to provide her eggs is, for IRS purposes, taxable income, or, instead, recovery for physical damages, which would make that payment tax-free. An introduction to this case is available in my earlier Bill of Health post: Can you be taxed for selling your eggs?, and at greater length in last year’s Taxing Eggs: A Mini Symposium, over at the Faculty Lounge. And the opinion cites thoughtful articles by Professors Kim Krawiec, Bridget Crawford, and Lisa Milot.)

The legal question presented was whether the payments Perez received are tax-exempt “damages” under Section 104 of the Internal Revenue Code. The court held they did not, and thus could be taxed. Judge Holmes observed that the contracts had characterized those payments as consideration for pain and suffering rather than the eggs themselves. He explained that “the injury here, as painful as it was to Perez, was exactly within the scope of the medical procedures to which she contractually consented.” Accordingly, “the payments were made not to compensate her for some unwanted invasion against her bodily integrity but to compensate her for services rendered.” Despite the pain and danger Perez incurred through the process of egg retrieval, Judge Holmes affirmed that “the money she received was not ‘damages'” because “she voluntarily signed a contract to be paid to endure” those risks. I’d be interested to learn whether readers find persuasive the Court’s provocative analogies to egg “donation”: Continue reading

Raising the King v. Burwell Stakes

By Nicolas Terry

Today, the Washington Post ran an interview with Laurence Tribe about the King v. Burwell subsidy litigation (recall that oral arguments are scheduled for March 4). Tribe speculated that Chief Justice Roberts will once again be the swing vote, as he was in Nat’l Fed. of Independent Bus. v. Sebelius. Tribe seems to predict another pragmatic Roberts opinion (and one that might bring Justice Kennedy along), finding the subsidy provisions are at worse ambiguous and that the executive is owed deference as argued by the eminently reasonable Nick Bagley.

Even though Tribe wouldn’t label Roberts as a consequentialist, he does believe that the pragmatic Roberts would be influenced by the impact on the States, the disruption of insurance markets, and the consequences for the newly insured. If the Chief wants more data on those issues he could do no better than to consult two excellent reports from the Urban Institute. The first estimates that a declaration that the subsidies are invalid “would increase the number of uninsured in 34 states by 8.2 million people… and eliminate $28.8 billion in tax credits and cost-sharing reductions in 2016 ($340 billion over 10 years) for 9.3 million people.” Perhaps as important, the Urban Institute’s model also predicts general turmoil in private, non-group insurance markets as the young and healthy would disproportionately drop coverage, causing a predicted 35% increases in premiums.

The second and most recent brief from the Urban Institute begins to put faces on those who will suffer: “Over 60 percent of those who would become uninsured are white, non-Hispanic and over 60 percent would reside in the South. More than half of adults have a high school education or less, and 80 percent are working.”

The executive shouldn’t need such help given the ACA’s clear intent as to how the federal and state exchanges were meant to function. But, if a dose of pragmatism is required to secure a majority of the Court, the stakes couldn’t be any clearer.

Should patients be able to limit doctor access to medical records?

by Vadim Shteyler 

The growing accessibility of Electronic Health Records (EHRs) across hospitals and practitioners raises new concerns about patient privacy. Before EHRs, patients had control over how much information they shared with each healthcare provider. Receiving patient information from other practitioners has required a signed consent form specifying the information patients are comfortable sharing (e.g., radiological studies, mental health history, sexual history, etc.). And hospitalists have been expected to request the minimal necessary information to provide good care. With growing networks and increasing compatibility across EHRs, more providers now have access to information without the patients’ express permission or even awareness.

Recent works published in the Journal of General Internal Medicine reported the results of a study that designed and recorded patient and provider experiences with a patient-controlled EHR (in which patients chose which providers could access which data in their medical records). A preliminary survey showed that, before the study, only 10 percent of patients had access to their medical records. Half of surveyed patients did not know what information their EHR contained. However, all patients wanted access to their EHRs. Meanwhile, another study reported that only one-third of physicians thought patients should have EHR access. Continue reading

Recommended Reading: New Empirical Analysis of False Claims Act Whistleblower Litigation

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the first three at Jotwell, here.) Private Enforcement’s Pathways, like the articles that precede it, brings a welcome dose of data and empirical analysis to a controversial area of the law, the debate over which has at times generated more heat than light.

Professor Engstrom’s analysis rests on a database he built containing information on the roughly 6,000 unsealed FCA cases that have concluded in a litigated judgments or settlement since 1986. In response to Freedom of Information Act requests, the Department of Justice provided information on the judicial district in which each case was filed, the date that DOJ decided whether or not to join each case, and the outcome of each case (including the amount, if any, that the government recovered and the whistleblower’s share of that recovery). DOJ also provided the date of filing for the 3,000 cases filed since 1986 that remain under seal, as well as for the 6,000 unsealed cases. From PACER, Professor Engstrom retrieved information on the parties, law firms, and individual lawyers involved in each unsealed case. Continue reading