Sentinel Policy Surveillance: A New Front in Legal Epidemiology?

Paul Erwin, Associate Editor of the American Journal of Public Health, recently wrote about the establishment of a  Sentinel Practitioner Surveillance System for Policy Change Impact,  or what might be called “sentinel policy surveillance.” The network of twelve diverse health officers will be trying to identify and share instances of harmful impact from Trump administration policies.

Erwin is suitably circumspect about what such a network can do. It is, he writes, no replacement of research, and, indeed, may be reporting perceived or feared effects as often as real ones.  I found the idea intriguing to ruminate on, though.  What follows are some scattered thoughts about the concept. I hope readers will add theirs.  Mostly I am interested in how the practice fits with general policy surveillance and public health law researchRead More

Well-rested versus well-trained doctors: New twist in debate over resident duty hours (Part II)

By Brad Segal

When people fall acutely ill, they deserve a non-sleep deprived doctor—but they also deserve an adequately-trained doctor. There are only so many hours to the day, and so in medical education a resident’s need for self-care must be balanced against the need for maximum clinical exposure. Since 2003, when restrictions to resident duty hours were first enacted, there has been disagreement about how to best navigate the tension. Recently, the debate resurfaced when the Accreditation Council for Graduate Medical Education (ACGME) proposed a change to the policy governing resident duty hour limits. Perhaps the most surprising part of the announcement was that their proposal increased the time limit that interns (first year residents) can care for patients without sleep. The policy ACGME enacted in 2011 had capped interns at 16 hours on-call, and the proposal increases the limit to 28 hours.

In my prior post I raised arguments for and against the proposed changes to duty hour limits. Here I will unpack the conclusions and limitations of the best empirical evidence available to ACGME: the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Published in the New England Journal of Medicine (NEJM) in 2016, the FIRST Trial randomized 117 surgical residency programs nationwide to have either “standard” duty hour policies, which included the current 16-hour cap on interns, or “flexible” policies, which reflect the recent ACGME proposal. Data were collected from July 2014 to June 2105. The sister-study involving medical residencies nationwide has regrettably not yet published.

The FIRST Trial warrant close attention because, like a Rorschach test, different people see different things in the data. For instance, take the finding that neither group caused significantly more or less harm to patients, though shorter duty hours were associated with more handoffs of patient responsibility. Taken at face value, these results neither clearly bolster nor contradict the proposed duty hour changes; yet they are used to both support and undermine the tentative changes to ACGME policy. The study’s first author told NPR that, “We believe the trial results say it’s safe to provide some flexibility in duty hours.” On the other hand, an editorial published in NEJM alongside the study argues that, “The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care.” Is there a right conclusion to draw from the study? Read More

New twist in debate over resident duty hours (Part I)

By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Read More

The Competing Identities of Neuroethics

By Brad Segal

This past week week I attended the International Neuroethics Society’s (INS) annual conference in San Diego, California. Neuroethics is multidisciplinary field that grapples with the implications of neuroscience for—and from—medicine, law, philosophy, and the social sciences. One of the many excellent panels brought together scholars from each of these four disciplines to discuss the diverse approaches to the field. The panel featured; Paul Appelbaum, a Professor of Psychiatry at Columbia University; Tom Buller, Chair of philosophy at Illinois State University; Jennifer Chandler, Professor of law at the University of Ottawa, and; Ilina Singh, Professor of Neuroscience & Society at the University of Oxford.

The panel started by considering the importance of the “competing identities” present in the field of neuroethics. As moderator Eric Racine explained, right from the start, even the term ‘neuroethics’ suggests a tension. Consider the variety of research methodologies employed in the field. For instance, a scholar trained in philosophy might approach neuroscience from a conceptual and purely analytical basis, and yet a social scientist might research the same question by collecting empirical interview data. The interplay between empirical and theoretical work was a theme that defined the discussion.

A psychiatrist by training, Dr. Applebaum spoke on the medical approach to the field. He argued that a focus on ethical issues in clinical psychiatry and neurology should be viewed as a part (but only a part) of neuroethics. Furthermore, medicine’s empirical approach to neuroethics is one (but not the only) way to advance thinking on neuroethical issues. Read More

Organs and Overdoses: The Numbers (Part I)

By Brad Segal

The surging opioid epidemic is a threat to the nation’s public health. This year the CDC reported that mortality from drug overdose reached an all-time high, with the annual death toll more than doubling since 2000. Yet in the backdrop of this epidemic, the country also faces ongoing shortages of a different sort–too few organs for transplantation. Every day, approximately 22 people die while waiting for an organ to become available. To some it is not a surprise–or at least not inconceivable–that the fastest-growing source of organ donors is being fueled by the national spike in drug overdoses. This first post will help delineate the scope and scale of the situation. My follow-up will discuss the ethical considerations and ramifications for public policy.

To start: the numbers. The Organ Procurement and Transplantation Network (OPTN) makes domestic transplant data publicly available online, which currently extends from 1994 to September 30th, 2016. Two decades ago, 29 organ donors died from a drug overdose.* In just the first nine months of this year, that number has climbed to 888 donors. Even with a quarter of the calendar year left to be counted, 2016 has already surpassed previous record set in 2015 (Figure 1).

figure-1
Figure 1

One might question whether this trend is an illusion–perhaps a rise in the incidence of donors who had overdosed reflects an increasing number of transplants. But the data suggest the opposite. Also plotted in Figure 1, the percentage of total organ donors who died from overdose (maroon diamonds, right-sided Y axis) has not remained constant–instead, the percentage has steadily increased. Two decades ago, overdose caused the deaths of 0.6% of all organ donors; this year, it is the cause of death among 12.0% of organ donors nationwide. The rising percentage means that not only are more victims of drug overdose donating organs, but that the pool of organ donors is increasingly composed of such individuals. Read More

Prior Authorization Policies for Pediatric ADHD Medication Prescriptions

According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.

In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.

In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.

The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.

States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.
States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.

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Should a patient have a right not to know genetic information about him or herself?

By Benjamin E. Berkman, JD, MPH

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual’s entire genome has not been without controversy.  Producing information on this scale seems to violate some of the accepted norms governing how to practice medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated.  One of these widely accepted norms was that an individual had a right not to know (“RNTK”) genetic information about him or herself.  Prompted by evolving professional practice guidelines, the RNTK has become a highly controversial topic.  The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned.

In a recent paper published in Genetics in Medicine, my coauthors and I provide some data that illuminates this and other issues. Our survey of 800 IRB members and staff about their views on incidental findings demonstrates how malleable views on the RNTK can be.  Respondents were first asked about the RNTK in the abstract: “Do research participants have a right not to know their own genetic information?  In other words, would it be acceptable for them to choose not to receive any GIFs?”  An overwhelming majority (96%) endorsed the right not-to-know.  But when asked about a case where a specific patient has chosen not to receive clinically beneficial incidental findings, only 35% indicated that the individual’s RNTK should definitely be respected, and 28% said that they would probably honor the request not to know.  Interestingly, the percentage of respondents who indicated that they do not support the RNTK increased from 2% at baseline to 26% when presented with the specific case.  The percentage of people who are unsure similarly jumps, from 1% to 11%.

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The Good, the Bad, and the Ugly: Physician Coverage under the ACA

By Elizabeth Guo

A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.

Here’s where it gets ugly.

Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.

The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Read More