Category: Health Law Policy

Educating ELSI

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By Matthew L Baum

“Examining the intersection of law and health care, biotech & bioethics”

– the subtitle of the Bill of Health blog.

I approach this intersection like many of my fellow students: outfitted with the tools and spectacles of a specific discipline. Whether that is health law, policy, medicine, engineering, philosophy, genetics, or cognitive science, none of us have had the ideal education that would enable not only an approach, but an inhabitation of this intersection.

What would that ideal education be? To consider the ideal education for a citizen, Rousseau conducts an elaborate thought experiment giving that education to a fictional young boy named Emile (hence the title of the work: Emile, or On Education). Let us begin a similar experiment to consider the ideal education for someone to inhabit the intersection of law and health care, biotech & bioethics.

Let’s call our fictional young person, ELSI.

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HHS Proposes Rule to Amend NOTA, Nullify Flynn v. Holder

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By Michelle Meyer

On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.

Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,

‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation

(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”

So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Read More

Government Regulation of the Practice of Medicine: How the FDA overreaches the regulation of medical practice

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By Richard Epstein

A sound scheme of public regulation seeks to find the best way to align the incentives of public regulators with the interests of the public at large.  That task has proven to be particularly acute with the U.S. Food and Drug Administration, which possesses vast powers to regulate the manufacture and distribution of drugs and medical devices in the United States, which it all too often overuses.

In a recent study for the Manhattan Institute entitled The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation, I examine the FDA’s over-regulation of new stem-cell technology in connection with the 2012 decision of Judge Rosemary Collyer (District Court of the District of Columbia) in Regenerative Sciences LLC v. United States.

That case examined the line between the regulation of pharmaceutical products on the one hand and the practice of medicine on the other. It is well established that the FDA has power over the former, but lacks power over the latter.  That distinction is of no small consequence because it allows, for example, for the rise of an extensive market in “off-label use” by physicians of drugs for purposes for which they have not received FDA approval.  This class of drug use is very large, and in cancer cases is thought to be more common than treatment using FDA-approved products.

The persistence of off-label drug use should caution people about allowing the FDA to exert extensive control over the drug licensing process.  It could be that the thousands of physicians, hospitals, and patients that use drugs off-label have, time after time, all made some major mistake.  Or it could just be possible that the accumulated level of institutional knowledge post-release demonstrates that the FDA has been too restrictive in its decisions as to whether a new drug should be allowed into the marketplace in the first instance. The FDA is heavily incentivized to be tough in its approval process lest it take heavy criticism for the all-too-visible injuries that may be caused by approved drugs. But in the social calculus, the individual losses that occur to people who are denied treatment by the heavy-handed actions of the FDA count every bit as much.  Yet these diffuse losses, often undocumented, bring much less heat to the FDA, which accordingly is prepared to shrug them off as a cost of supplying people the “protection” that is so central to the FDA mandate.

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The priorities in the benefit packages vs. the priorities of those who dole out the benefits

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In my last post I promised I would provide details about the new piece of statutory legislation that was recently enacted by the Colombian Congress on the right to health, but first I should talk a little more about the prior jurisprudence that set the stage for it–especially since there’s so much of it. Every year, hundreds of thousands of right-to-health cases go before judges in Colombia, and some estimate that up to one out of every five Colombians has used the judicial system to gain access to health services.

By far, most of these cases are won by the plaintiff. And they should be.

Nearly 90% of the cases that involve procedures, and over 30% of the cases for medications, involve benefits that are actually already covered by the public benefit package (plan obligatorio de salud, or POS). And most of these aren’t over particularly expensive, complicated, or scarce benefits in the POS. The most frequently litigated medications are omeprazole (Prilosec) and oxygen. The most frequently litigated procedures aren’t even the procedures themselves, but specific parts of the procedures that aren’t explicitly listed in the bundle of benefits covered by the POS. For example, the POS covers colostomies, but the insurance companies systematically deny the colostomy bags. “We’ll open the hole in your flank, but it’ll be on you to figure out what to do with the excrement that’ll start oozing out. . .”

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HBR/NEJM online forum on health care innovation

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By Nicholson Price

For those of you who haven’t seen it yet, there’s a great ongoing online forum over at the joint Harvard Business Review and New England Journal of Medicine Insight Center on Leading Health Care Innovation.  It’s online at HBR here, and will feature an ongoing series of posts about innovation in high-value health care through November 15.  Short articles from scholars in various fields will focus on three main areas: Big Ideas (foundational principles of high-value health care); Managing Innovations (organization and delivery); and From the Front Lines (stories of specific case solutions from practitioners).

They’re looking to host a lively forum, so comments seem both quite welcome and unusually thoughtful so far.

 

Live Blogging: The Globalization of Health Care, Legal and Ethical Issues

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By Holly Fernandez Lynch

This afternoon the Petrie-Flom Center co-hosted a panel discussion (with the HLS Library and the Harvard Global Health Institute) of Glenn Cohen‘s new edited volume out from Oxford University Press, The Globalization of Health Care: Legal and Ethical Issues.  Panelists were Professor Cohen, Sue Goldie, and Neel Shah; Einer Elhauge served as moderator.  This isn’t quite *live* blogging because the event just finished, but here were some of the highlights:

  • Professor Cohen began by describing the book and its contents, noting the theme that health care is becoming global – just like everything else.  The book is broken up into five sections:
    1. Medical Tourism: This is the phenomenon of patients traveling abroad for the primary purpose of getting care, in order to save on costs or to access procedures and technologies that are not available in their home country. The number of medical tourists is high (for example in 2010, nearly a million Californian’s traveled to Mexico for care), as are the profits (it’s been estimated that India’s revenues from medical tourism are around $2.2B annually).  This section of the book addresses a variety of related issues, including lessons about accreditation and safety for medical tourists, insurance coverage and encouragement for services abroad (and travel costs), media coverage of medical tourism, distributional justice issues in terms of diverting access to care for local patients, and legal questions related to tourism for services that may be illegal in a patient’s home country. Read More

On Access and Accountability: Two Supreme Court Rulings on Generic Drugs

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By Marcia Boumil and Gregory Curfman

In 2013 the U.S. Supreme Court issued two important rulings in cases involving the marketing of generic drugs. In Federal Trade Commission v. Actavis, the Court addressed the law governing a controversial pharmaceutical marketing practice known as reverse payment agreements, or pay for delay – a byproduct of the Hatch-Waxman Act.  This occurs when a generic drug company identifies a vulnerable patent held by a brand-name drug manufacturer and seeks Food and Drug Administration (FDA) approval for a generic version before the patent expires, provoking a lawsuit by the brand-name company for alleged infringement. A subsequent settlement involves the brand-name company paying the generic company to delay commercialization of its product (but not beyond the expiration of the patent). The FDA alleged that reverse payment agreements violate antitrust laws. The Supreme Court held that their validity would be evaluated on a case-by-case basis using the “rule of reason” standard. According to this standard, only those agreements that restrain trade will be viewed as violations of anti-trust law.

In the second case, Mutual Pharmaceutical v. Bartlett, the Court affirmed its 2011 ruling in Mensing v. PLIVA and held that generics manufacturers are substantially immune from civil claims regarding injuries caused by their products whether the tort claim be based upon failure to warn (Mensing) or design defect (Bartlett). The basis of the decision resides in the FDA requirement that generic drug labels be consistent with the label of the brand-name equivalent. Just days after the Bartlett decision issued, the FDA indicated its intent to propose a revision to the labeling requirements for generic drugs to create parity with branded drugs. If adopted, this revision could vitiate the law set forth in Mensing and Bartlett.

For more coverage of these cases, see the New England Journal of Medicine essay here.

 

An Apple A Day . . . the Doctor’s Prescriptions Say?

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As public health concerns over obesity and diabetes continue to rise, physicians, public health organizations, and medical educators are thinking out of the box — and into the kitchen and grocery store.  Two stories done by NPR this week feature programs aimed to increase physician influence in patient dietary choices.  The first article describes Wholesome Wave, a program in which a physician writes a “prescription” for fruits and vegetables in the form of a voucher for overweight or diabetic children (and their families).  The second article reports on a collaboration between Tulane University School of Medicine and Johnson & Wales University College of Culinary Arts.  The hope for the two schools is for both groups of students to learn more about nutrition.

Hearing these two stories reminded me of work I did as a student at the Harvard Legal Services Center, working with the Mississippi Food Policy Council to get food stamps accepted at farmers’ markets and improve access to fruits and vegetables.  Most would agree (including Michelle Obama) that providing access to fruits and vegetables in “food deserts” is a laudable goal, but I’m struck by the way in which “prescriptions” for healthy foods versus providing access to healthy food changes the level of autonomy patients have in choosing what they eat.

Couple programs like Wholesome Wave with the ACA’s increased incentives for wellness programs, and I wonder how much a doctor, employer, or insurance plan may dictate consuming that one apple (or bunch of kale) per day.  As Professor Matt Lamkin described in his work last year, some employer insurance plans contain high deductibles ($4,400 in the example he describes) that are much lower ($400) if a wellness plan is followed, which often includes following a doctor’s recommendations.  In the example Lamkin uses, a patient must choose between continuing unpleasant chemotherapy or paying thousands dollars more to satisfy the obligations of a higher deductible.  What if patients want to toss out a doctor’s “prescription” for kale and grab a KitKat instead?

While combating obesity and diabetes is of tantamount importance, how much outside influence over what we eat (or what our children eat) is too much influence?   I’m not sure where I come down on this issue, but it gives those of us simultaneously concerned with public health and patient autonomy something to chew on . . .

There’s an App for This: The Constitution

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[Guest post from the Library of Congress]

Direct Access to Expert Analysis of the Supreme Law of the Land   

The Senate Committee on Rules and Administration, the Library of Congress, and the Government Printing Office (GPO) mark Constitution Day today by launching a new app and web publication that make analysis and interpretation of constitutional case law by Library experts accessible for free to anyone with a computer or mobile device.

The new resources, which include analysis of Supreme Court cases through June 26, 2013, will be updated multiple times each year as new court decisions are issued. Legal professionals, teachers, students, and anyone researching the constitutional implications of a particular topic can easily locate constitutional amendments, federal and state laws that were held unconstitutional, and tables of recent cases with corresponding topics and constitutional implications.

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