DUE MONDAY: Call for Abstracts for Petrie-Flom Center 2014 Annual Conference

The Petrie-Flom Center invites abstracts for its 2014 Annual Conference: “Behavioral Economics, Law, and Health Policy.” The conference will be held at Harvard Law School on May 2 and 3, 2014, and seeks to address the following questions:

  • Are there features unique to health and health care that prevent individuals, groups, and policymakers from making the best decisions?  What is a “best” decision, i.e., whose perspective should be paramount?
  • What types of barriers exist to rational decision making in the health care context, and what does rational decision making look like here?
  • Is exploitation of framing effects, default rules, nudges, and other elements of choice architecture appropriate when it comes to human health, or is this an area where pure autonomy should reign – or perhaps strong paternalism is needed? Is health policy special?
  • What should policymakers do when there is conflict between outcomes that might be good for individuals but not society more generally, and vice versa?  Where should the nudges push?
  • Which areas of health law, bioethics, and biotechnology policy are most amenable or resistant to manipulation of choice architecture?  When nudges are not plausible, what is the best way to overcome bounded rationality?
  • When might behavioral economics lead to the wrong results for health law, bioethics, and biotechnology policy?
  • How can manipulations of choice architecture be best evaluated empirically, and what ethical concerns might such research raise?
  • What are the most interesting or compelling health law, bioethics, and biotechnology policy nudges we should be thinking about today in the realms of obesity, organ donation, end-of-life care, biospecimen ownership and research, human subjects research, HIV testing, vaccination, health insurance, and other areas?

Please note that this list is not meant to be at all exhaustive; we hope to receive papers related to the conference’s general theme but not specifically listed here.

Calls for abstracts are due by December 2, 2013.

For a full conference description, including the call for abstracts and registration information, please visit our website.

Only a Right to Health

By Nathaniel Counts

Human rights disaggregates otherwise related issues into separate rights.  We discuss rights to health, education, housing, association, etc., and, in countries where these rights are codified, we litigate each one separately in the courts.  We also know that each of these issues for which there is a corresponding right is, to some extent, a symptom of poverty.  In some cases it might not be possible to treat the symptoms without addressing the root cause.  For example, in 1966, the Coleman study on equality in education found that “[s]chools bring little influence to bear on a child’s achievement that is independent of his [or her] background and general social context.”  These findings have been contested, but it is likely that socioeconomic factors are a determinant of a child’s academic success, along with the educational experience itself.  If the socioeconomic background is the greater determinant, it may not make sense to use scarce government resources to fund school improvement rather than addressing poverty itself.  In a country with a right to education, school improvement could be litigated and potentially derail national efforts to address root causes.

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30 Pound Turkeys, 30 Million Pounds of Antibiotics

Since 1960, the weight of an average live domesticated turkey has nearly doubled from around 15 to 30 pounds.   And current estimates are that 30 million pounds of antibiotics are used in livestock production per year (which represents 80 percent of the total volume of antibiotics sold in the United States for any purpose).  These two facts are related.

The use of antibiotics in livestock is often not for the purpose of curing disease, but rather for the purpose of growth promotion—a practice that has arisen with the intensification of livestock farming.  Although the mechanism underpinning their action is unclear, it is believed that the administration of antibiotics at non-therapeutic doses suppresses sensitive populations of bacteria in the intestines, helping animals digest their food more efficiently.

This non-therapeutic use of antibiotics continues despite clear evidence that the overuse of important antibiotics for humans in the livestock industry spreads dangerous antibiotic resistance. Read More

Recommended Reading: “A First Amendment Approach to Generic Drug Manufacturer Tort Liability”

By Jeremy Kreisberg

The November 2013 issue of the Yale Law Journal features a very interesting comment on an important issue at the intersection of health law and policy.  A First Amendment Approach to Generic Drug Manufacturing, by Connor Sullivan, argues that the First Amendment principles underlying the Supreme Court’s opinion in Sorrell v. IMS Health Inc. provide a viable legal avenue for challenging the FDA regulations that prevent generic drug manufacturers from sending letters warning physicians of the risks of their drugs.

These FDA regulations became a source of legal controversy when the Supreme Court heard PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a case concerning whether the FDA’s requirement that generic drug manufacturers use the same labels as brand name manufacturers preempts state tort laws that allow injured parties to challenge the sufficiency of a generic manufacturer’s warnings.  The Court held that the FDA requirements did pre-empt state tort law on the theory that a generic drug manufacturer could not comply with both the FDA labeling requirements and state tort law at the same time because state tort law might require different, greater warnings than the brand name manufacturer of that same drug used.  The Court noted the unfortunate inconsistency that had befallen the plaintiffs in the case; had they taken the brand name drug, they could challenge the labeling requirements of the brand name manufacturer, which has the flexibility under federal law to change their labeling scheme.  But because the plaintiffs took the generic version of the same drug, their suit was foreclosed.

We might intuitively assume that these plaintiffs could simply sue the brand name manufacturer; after all, it is their poor labeling scheme that the plaintiffs were challenging by noting the deficiencies in the generic manufacturer’s similar label.  But the law is not so wise.  After many attempts and subsequent failures to convince a court of such an argument, the law has virtually foreclosed any mechanism for an injured party to recover from a brand name manufacturer for the labeling deficiencies that are passed onto a generic manufacturer.  Indeed, Sullivan cites to Gardley-Starks v. Pfizer, Inc., 917 F. Supp. 2d 597, 604 n.4 (N.D. Miss. 2013), which noted that “sixty-six decisions applying the law of twenty-three different jurisdictions [have held] that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product.”

In sum, the combination of FDA rules and a Supreme Court pre-emption decision has created a real inconsistency in how people experience the tort laws as applied to their drug manufacturers.  After the jump, I’ll explain Sullivan’s idea for solving this problem.

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SCOTUS and the Contraceptives Coverage Mandate

As everyone and their brother expected, SCOTUS has just decided to take up two cases challenging the contraceptives coverage mandate: Hobby Lobby, in which the 10th Circuit ruled in favor of the religiously-objecting (but secular, for-profit) employer, and Conestoga, in which the 3rd Circuit went the other direction, maintaining that “for-profit, secular corporations cannot engage in religious exercise.”

I think the First Amendment piece of this is pretty much open-and-shut: the requirement that employers offer health plans that provide contraceptives coverage free of charge is pretty clearly neutral and generally applicable.  Arguments around the Religious Freedom Restoration Act are much more interesting.  For our non-lawyer readers, the basic idea behind RFRA is that the federal government may not (1) substantially burden the right to free exercise of religion, unless it does so (a) in furtherance of a compelling interest, and (2) using the least restrictive means.  This is a high hurdle, otherwise known as strict scrutiny.

You can see several clear decision points under the RFRA analysis, and pretty much any one of them could go either way:

Do for-profit corporations have a right to free exercise?

As a threshold matter, RFRA offers protection only to those entities with free exercise rights.  Citizens United tells us that “corporations are people, my friend.”  So if that analysis applies to both the First Amendment’s free speech rights and free exercise rights, then corporations can at least pass go.  On the other hand, some courts have maintained that religion can only be exercised by individuals or religious organizations, such that RFRA would not apply to secular, for-profit corporations.

Does the contraceptives mandate impose a substantial burden? 

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A Little Choice About PPACA Risk Corridors That Could Have Big Consequences

The Patient Protection and Affordable Care Act has made even the most technical questions of healthcare coverage regulation newsworthy. Policy questions that would be noticed only by experts and interested parties in the regulation of Medicare or Medicaid, even with billions of dollars in taxpayer or beneficiary money at stake (think DSH and the transition to MS-DRGs), are front-page news when they have a connection to the PPACA.  The best example may be the recent attention to the PPACA’s risk corridors, which was the subject of an op-ed by Senator Rubio last week that led to a lot of discussion in the press.  (For background on the risk corridors, as well as their cousins, the risk adjustment program and transitional reinsurance, see the helpful efforts of Seth Chandler, Mark Hall (also here), and Timothy Jost.)

In that spirit, I noticed in my research a tiny regulatory policy choice made by the HHS about the risk corridors that may wind up making news one of these days, in a lawsuit or otherwise.  It has to do with the way the risk corridor payments are calculated, and could have an impact on the extent of taxpayer liability for risk corridor payments.  Read More

Fox interviewed on NPR about FDA’s Ban on Direct-to-Consumer Genetic Testing

Bill of Health Contributor Dov Fox was interviewed today on NPR’s “Marketplace” about the FDA’s decision to ban all sales of direct-to-consumer genetic testing by 23andMe.

23andMe provides information about genetic health risks to people who buy at-home “DNA spit kits.” The company seeks to inform consumers about their susceptibility to more than 250 diseases. But the FDA now says the company hasn’t proved the tests are accurate enough, and the agency is worried Americans are relying on the results instead of visiting their doctor. The FDA exercised its jurisdiction under the Food Drug & Cosmetic Act to regulate the DNA spit kits as a genetic device used in the diagnosis or treatment of disease.

“This field of personalized medicine is really in its infancy,” said Fox, “and its terrifically exciting what we might learn one day, but its just not there yet. 23andMe hasn’t shown that their reports about your health from your genes alone are all that useful. They’re just not accurate at this time in the way that the FDA requires.”

Critics say regulators are standing in the way of consumers having the convenience of obtaining information about their own health at a reasonable price point without an expensive trip to the doctor.  According to Fox, it’s a powerful argument that is often made by genetic testing companies such as 23andMe. The problem is the public’s understanding of genetics is very low. “These tests,” he argued, “come not only with limited accuracy, but also without the benefit of genetic counseling.”

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The Co-Pay Coupon Controversy: Time for Detente?

By Kate Greenwood

Cross-Posted at Health Reform Watch

At the end of last month, the Secretary of Health and Human Services Kathleen Sebelius made headlines when, in a letter addressed to Representative Jim McDermott (D-WA), she announced that “[qualified health plans], other programs related to the Federally-facilitated Marketplace, and other programs under Title I of the Affordable Care Act” were not “federal health care programs under section 1128B of the Social Security Act”.  One implication of the Secretary’s interpretation is that the “anti-kickback act”, which is found in Section 1128B, does not apply to qualified health plans.  And that, in turn, means, among other things, that individuals insured under those plans, unlike individuals on Medicare or Medicaid, will be able to use drug company coupons to defray the cost of their prescription drugs.

Prescription drug coupons have been a source of controversy, favored by branded manufacturers and patients, and opposed by generic manufacturers, health insurers, third party payers, and pharmaceutical benefit managers.  Joseph Ross and Aaron Kesselheim studied a large number of coupons advertised on the website www.internetdrugcoupons.com and found that “62% (231 of 374) were for brand-name medications for which lower-cost therapeutic alternatives were available.”  Ross and Kesselheim argue that the coupons are costly at the population level, but also for individual patients.  This is because the coupons are nearly always time-delimited and the short-term savings do not typically outweigh the long-term cost of taking a branded drug.  On the other hand,  in an article in last week’s JAMA, Leah Zullig and colleagues pointed out that reducing co-payments has been proven to improve medication adherence, a problem which there “is an increasing business case for addressing[.]”

The coupon controversy has carried over into the courts.  On March 7, 2012, seven lawsuits were filed in district courts by third party payers against a number of drugmakers, alleging that prescription drug coupons violate antitrust, commercial bribery, and racketeering laws.  (This post at FDA Law Blog includes links to the seven complaints, and this one provides an update on the status of the litigation as of late June 2013.)

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The “Emergency Room” Doctrine (a.k.a. Doctors’ Virtual Immunity Against Suit)

By Alex Stein

Under Georgia statute (that exists in other states as well), allegations of medical malpractice “arising out of the provision of emergency medical care in a hospital emergency department or obstetrical unit or in a surgical suite immediately following the evaluation or treatment of a patient in a hospital emergency department” must show “gross negligence” and be proven by “clear and convincing evidence.” OCGA § 51–1–29.5(c). Failure to prove the defendant’s gross negligence by clear and convincing evidence should result in a dismissal of the plaintiff’s suit.

In a very recent case, Johnson v. Omondi, — S.E.2d —-, 2013 WL 6009480 (Ga. 2013), the Supreme Court of Georgia interpreted and applied this provision.

Based on its prior decisions, the Court defined “gross negligence” as the defendant’s “failure to exercise even a slight degree of care.” The Court also ruled that in deciding a motion for summary judgment, the trial judge “must view the evidence presented through the prism of the substantive evidentiary burden”: clear and convincing evidence. Hence, it is the plaintiff’s burden to produce evidence upon which a reasonable jury could determine that the defendant completely failed to deliver the requisite medical care. Specifically, the plaintiff’s expert witness must give an unequivocal account of the defendant’s profound unprofessionalism. Absent such testimony, the trial judge should dismiss the suit summarily. Read More

Health Insurance & Patient Responsibility, Part II

By Deborah Cho

In my first post, I introduced the general problem of patients not being fully informed about their health insurance policies and instead relying on providers to correctly apply each patient’s unique policy when making medical decisions.  Though patients are ultimately responsible for abiding by the terms of their individual insurance plans, there may be ways that health care providers can help patients avoid being stuck with unnecessary and unmanageable medical bills.

One solution might be to make giving a general statement about the importance of understanding how your health insurance policy relates to recommended care become standard practice during patient encounters for physicians and other health care providers.  Health care providers can, for example, add something along the lines of “You may wish to check with your insurance plan to see if this is covered” when providing a recommendation for treatment or when providing a referral.  Such practice should not place liability on health care providers to guarantee that patients have an accurate understanding of their insurance coverage.  Instead, insurance coverage and medical debt should be viewed as factors that can directly affect a patient’s health and well-being, thus deserving a few moments of the patient encounter whenever possible (perhaps similar to brief counseling on smoking cessation, which is covered only if appropriate and timely).

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