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Implementing Health Reform: Wraparound Coverage Excepted Benefits And Draft 2016 Letter To Issuers (Updated)


December 20th, 2014

In December 19, 2014, in what one hopes were their last major regulatory actions before the holidays, the Departments of Labor, Health and Human Services, and Treasury released a proposed rule on a new excepted benefit for wraparound coverage, while the Centers for Medicare and Medicaid Services released a Draft 2016 Letter to Issuers in the Federally Facilitated Marketplace.

This post will describe the wraparound coverage proposed rule.   It will be updated in the next day or two to analyze the letter to issuers (issuers being the Affordable Care Act word for insurers.)  I will note briefly, however, that the letter to issuers is very similar to the 2015 letter to issuers, with two major exceptions.  First, because open enrollment for 2016 begins on October 1, rather than November 15, as in 2015, the time frame for completing regulatory review begins earlier and is quite compressed.  Second, the 2016 letter picks up on a few new regulatory initiatives for 2016, such as attempts to provide more accurate provider directories and formulary information.  These changes will be explored more thoroughly in the update to this post.

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Preparing US Hospitals To Safely Manage Ebola Virus-Infected Patients: At What Cost?


December 11th, 2014

Since Ebola first reached US shores this summer, hospitals nationwide have attempted to prepare. National guidance has been helpful, but no such guidance can deal with the fastidious attention to every minute and mundane aspect of caring for a patient with Ebola virus infection that could place a healthcare worker at risk if a breach occurs. Simulation training has helped to uncover defects and to assess our capacity to mitigate those defects.

Additionally, innumerable hours of countless healthcare workers, hospital administrators, infection control staff, facilities and environmental services providers, communications specialists, security personnel and others have been brought to bear focused on the task at hand. Despite this effort, in the 30 years since becoming a physician, I have never witnessed a greater, more palpable level of stress and anxiety among my peers.

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California’s Proposition 46 And The Uncertain Future Of Medical Malpractice Liability Reform


December 10th, 2014

On November 4, 2014, Californians voted against Proposition 46, an unprecedented statewide ballot initiative that would have, among other things, raised the $250,000 cap on noneconomic damages to $1.1 million and indexed it to the rate of inflation in future years. The margin was significant — 67 percent voted against it.

For nearly 40 years, noneconomic damages, which entail payments to patients for pain and suffering resulting from medical malpractice (as opposed to economic damages such as lost wages and medical costs), have been at the forefront of debates over the U.S. medical liability system. Currently, 22 states have caps on noneconomic damages of varying sizes in place. If it had passed, the ballot initiative would have raised the cap on noneconomic damages in California from among the most restrictive to the least restrictive among all states with caps.

Opponents of Proposition 46, and supporters of malpractice reform more generally, argued that raising the noneconomic damages cap would have increased malpractice awards and subsequently malpractice premiums, which would be passed on to patients and insurers as higher costs.

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From The National Coordinator For Health IT: The Federal Strategy For Collecting, Sharing, And Using Electronic Health Information


December 8th, 2014

Making our nation’s health and wellness infrastructure interoperable is a top priority for the Administration, and government plays a vital role in advancing this effort. Federal agencies are purchasers, regulators, and users of health information technology (health IT), as they set policy and insure, pay for care, or provide direct patient care for millions of Americans. They also contribute toward protecting and promoting community health, fund health and human services, invest in infrastructure, as well as develop and implement policies and regulations to advance science and support research.

The Office of the National Coordinator for Health IT (ONC) has a responsibility to coordinate across the federal partners to achieve a shared set of priorities and approach to health IT.  To that end, today we released the draft Federal Health IT Strategic Plan 2015-2020, and we are seeking feedback on the federal health IT strategy.  This Strategic Plan represents the collective priorities of federal agencies for modernizing our health ecosystem; however, we need your input. We will accept public comment through February 6, 2015. Please offer your insights on how we can improve our strategy and ensure that it reflects our nation’s most important needs.

A collection of 35-plus federal departments and agencies collaborated to develop the draft Federal Health IT Strategic Plan: 2015-2020, identifying key federal health IT priorities for the next six years (Exhibit 1). The landscape has dramatically changed since the last federal health IT strategyWhen we released that Plan, the HITECH Act implementation was in its infancy. Since then, there has been remarkable growth in health IT adoption. Additionally, the Affordable Care Act implementation has begun to shift care delivery and reimbursement from fee-for-service to value-based care.

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Recalling To Err’s Impact — And A Small But Telling IOM Mistake


November 25th, 2014

This year marks the 15th anniversary of the Institute of Medicine (IOM)’s To Err is Human report, which famously declared that from 44,000 to 98,000 Americans died each year from preventable mistakes in hospitals and another one million were injured. That blunt conclusion from a prestigious medical organization shocked the public and marked the arrival of patient safety as a durable and important public policy issue.

Alas, when it comes to providing the exact date of this medical mistakes milestone, the IOM itself is confused and, in a painful piece of irony, sometimes just plain wrong. That’s unfortunate, because the date of the report’s release is an important part of the story of its continued influence.

There’s no question among those of us who’d long been involved in patient safety that the report’s immediate and powerful impact took health policy insiders by surprise. The data the IOM relied upon, after all, came from studies that appeared years before and then vanished into the background noise of the Hundred Year War over universal health insurance. This time, however, old evidence was carefully rebottled in bright, compelling new soundbites.

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The Role Of Black Box Warnings In Safe Prescribing Practices


August 20th, 2014

In the Health Affairs article, “Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received black-box warnings or were withdrawn from the market for safety-related reasons prior to the 1992 Prescription Drug User Fee Act (PDUFA) with black-box warnings and safety-related withdrawals in the post-PDUFA era.

PDUFA for the first time authorized FDA to collect user fees from brand-name manufacturers that submitted New Drug Applications, with the funds being earmarked for more review staff (not until 2007 were funds also permitted to be used to expand post-approval safety surveillance capacity).

As a quid pro quo, the FDA was required to act on all new drugs within a fixed deadline: drugs given priority review designations because they were particularly promising therapies offering substantial improvements in treating serious conditions were to be reviewed within 6 months and standard review drugs were to be reviewed within 12 months (later shortened to 10 months in 2002). By all accounts, PDUFA substantially expedited the review process. The review times for new molecular entities decreased from an average of 33.6 months between 1978 and 1986 to about 10 months for drugs approved between 2001-2010.

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Better Measurement Of Maternity Care Quality


August 12th, 2014

A thought-provoking paper published this month in Health Affairs shows stunning variation in rates of obstetrical complications across U.S. hospitals. This type of research is important and necessary because focusing on averages masks potentially large differences in how patient care is provided and how clinical decisions are made.

From a policy perspective, it’s crucial to identify and learn from hospitals that are “positive deviants,” that is – hospitals with better-than-expected quality of care. From a pregnant woman’s perspective, having information on hospital rates of hemorrhage, infection, or laceration during childbirth is a high priority.

Authors Laurent Glance and colleagues add to a growing literature on variation in hospital-based maternity care. Having useful quality measurement and reporting strategies to guide policy and patient decisions is an essential next step. Indeed, Glance and colleagues conclude by urging clinicians and policymakers to “develop comprehensive quality metrics for obstetrical care and focus on improving obstetrical outcomes.”

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Examining Medicare’s Hospital Readmissions Reduction Program


July 24th, 2014

New financial incentives and penalties in the Affordable Care Act (ACA) designed to optimize health care system performance are proving difficult to manage, but they are also providing new opportunities for leaders to foster collaboration between acute and post-acute health care providers.

Perhaps one of the most promising, albeit controversial, programs has been Medicare’s Hospital Readmissions Reduction Program (HRRP), which penalizes hospitals with excess 30-day readmissions for health conditions such as pneumonia, myocardial infarction, and heart failure. Although not all hospital readmissions are preventable, many could be avoided with improved post-discharge planning and care coordination.

The HHRP was designed to penalize hospitals with excess 30-day readmissions regardless of whether the patient was readmitted to the same hospital or another hospital. Although there are some exceptions (for example, readmissions due to hospital transfers or planned readmissions), most readmissions of patients with health conditions targeted by the HHRP will count against a hospital.

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Empowering Patients As Partners In Health Care


July 24th, 2014

Recently, the National Patient Safety Foundation’s Lucian Leape Institute brought together 40 patient safety experts — health professionals, patients, advocates, and others — to develop recommendations for how best to engage patients and families in improving patient safety. They represented patient advocacy organizations, health systems, professional societies, researchers, and international safety organizations.

During the course of two lengthy roundtable discussions, participants were asked to reflect on an experience in which they or someone close to them had experienced harm at the hands of the health care system and how they responded. Among the stories we heard:

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The Role Of Sales Representatives In Driving Physicians’ Off-Label Prescription Habits


June 19th, 2014

Off-label prescribing is widespread in Canada and the United States (U.S.). One in nine prescriptions for Canadian adults are for off-label uses with the highest percentages coming from anticonvulsants (66.6 percent), antipsychotics (43.8 percent), and antidepressants (33.4 percent). Overall, 79 percent of the off-label prescriptions lacked strong scientific evidence for their use.

For 160 drugs commonly prescribed to U.S. adults and children, 21 percent were for off-label indications totaling 150 million prescriptions. In this case, 73 percent had little to no scientific backing and once again psychoactive drugs such as gabapentin had the highest level of off-label use.

Moreover, doctors do not seem to know what are and are not approved FDA use for many of the drugs that they prescribe. Now an article published in the June issue of Health Affairs by Ian Larkin and colleagues points to active promotion by sales representatives as one reason for the widespread off-label use of antipsychotics and antidepressants in children.

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Health Affairs June Issue: Where Can We Find Savings In Health Care?


June 2nd, 2014

The June issue of Health Affairs, released today, features various approaches to cost-savings in the U.S. health care system. A variety of articles analyze the effects of potential policy solutions on the Medicare and Medicaid programs and their impact on the health of beneficiaries and tax payer wallets.

Federal approaches to reduce obesity and Type 2 diabetes rates by improving nutrition could work—but the how matters. Sanjay Basu of the Stanford University School of Medicine and coauthors modeled the effects of two policy approaches to reforming the Supplemental Nutrition Assistance Program (SNAP), which serves one in seven Americans. They found that ending a subsidy for sugar-sweetened beverage purchases with SNAP dollars would result in a decrease in obesity of 281,000 adults and 141,000 children, through a 15.4 percent reduction in calories by the lowering of purchases of this source. They also found that a $0.30 credit back on every dollar spent on qualifying fruits and vegetables could more than double the number of SNAP participants who meet federal guidelines for fruit and vegetable consumption.

With more than forty-six million people receiving SNAP food stamp benefits, the authors suggest that policy makers closely examine the implications of such proposals at the population level to determine which will benefit people’s health the most and prove most cost-effective.

If you’re between ages 15–39 when you are diagnosed with cancer, the implications later in life extend well beyond your health. Gery P. Guy Jr. of the Centers for Disease Control and Prevention and coauthors examined Medical Expenditure Panel Survey data and determined that survivors of adolescent and young adult cancers had annual per person medical expenditures of $7,417, compared to $4,247 for adults without a cancer history. They also found an annual per capita lost productivity of $4,564 per cancer survivor — because of employment disability, missed workdays, and an increased number of additional days spent in bed as a result of poor health — compared to $2,314 for adults without a cancer history.

The authors suggest that the disparities are associated with ongoing medical care needs and employment challenges connected to cancer survivorship, and that having health insurance alone is not enough to close the gap. They stress the importance of access to lifelong follow-up care and education to help lessen the economic burden of this important population of cancer survivors.

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Recent Health Policy Briefs: Regulating Compounding Pharmacies and Basic Health Program Update


May 1st, 2014

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation examines the Compounding Quality Act, a law signed by President Obama in November 2013, which seeks to fill the gaps in the Food and Drug Administration’s (FDA’s) inspection and enforcement oversight of compounding pharmacies.

This law was enacted in the wake of a 2012 fungal meningitis outbreak, linked to a Massachusetts drug compounding company. The outbreak caused more than 700 people to become ill and left sixty-four dead. Before the new law was passed, compounding pharmacies were primarily regulated by states, not the FDA.

The compounding pharmacy industry initially catered to patients with specialized needs. Since the 1990s, many compounding pharmacies have also begun engaging in what is now called nontraditional compounding: manufacturing certain drugs in large quantities for sale to doctors’ offices and hospitals. This health policy brief traces the evolution of compounding pharmacies and the changes brought to this industry by the new law.

Also posted today: an update to an earlier brief that provides more information on the issues surrounding the Basic Health Program and outlines options for states.

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Responding To ‘The Hidden Curriculum': Don’t Forget About The Patient


April 3rd, 2014

Narrative Matters readers might remember Joshua Liao’s moving essay about the dangers of the Hidden Curriculum. Liao, a resident physician at Brigham and Women’s Hospital, wrote about the consequences of making a serious mistake as a medical student on an obstetrics rotation. He read the essay for the Narrative Matters podcast and it’s a great listen.

Liao’s essay, penned with Eric Thomas and Sigall Bell, also generated some compelling responses. It inspired Tim Lahey to write about his experience leading the curriculum redesign at Dartmouth’s Geisel School of Medicine. And when the Washington Post ran an excerpt of Liao’s essay last week, it led Franca Posner to remind readers about “one missing piece of this puzzle”: the patient’s perspective.

Posner was once in a similar situation, but it was she on the hospital bed: “I was that woman 20 years ago, only I was almost 40 and had a 5-year-old child and five miscarriages in my reproductive history,” Posner wrote in a letter to the editor published in the Post’s Health and Science section on March 31.

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Implementing Health Reform: Allowing Noncompliant Policies; Benefits And Payment Parameters Rule (Part 2)


March 7th, 2014

Editor’s note: Part 1 of this post discussed the Department of Health and Human Services March 5 bulletin extending until October 1, 2016 its transitional policy permitting the renewal of ACA non-compliant individual and small group health insurance policies. Part 1 also began examining the final 2015 Notice of Benefit and Payment Parameters rule, issued on the same date. Subsequent installments will discuss two final rules also issued March 5 by the Internal Revenue Service regarding reporting by insurers of minimum essential coverage and reporting by employers on coverage under employer-sponsored health plans.

Reduced notice requirement for new state exchanges. The final 2015 Benefit and Payment Parameters rule requires states that would like to begin operating their own exchanges to notify HHS of this intention by June 15 of the preceding year. Earlier rules had required a year’s notice.

Consumer assistance and privacy. States may permit web brokers to assist individuals, employers, and employees with enrolling in qualified health plans (QHPs) through their exchanges. Agents and brokers must comply with privacy and security standards protecting personally identifiable information and may not use it for marketing. The SHOP exchange, and not the web broker, is responsible for aggregating premiums and forwarding them to insurers. Web brokers must display information on all available QHPs, although insurers may refuse to provide non-appointed brokers with certain information. Web brokers must also provide enrollees with a disclaimer noting that they are not the exchange and may not have full information on all plans.

State exchanges must comply with federal personally identifiable information requirements, but may seek the approval of HHS to use this information to ensure the efficient operation of the exchange if they secure the consent of the individual whose information is to be used. Exchanges that disclose personally identifiable information to non-exchange entities (such as certified application counselors, in-person assisters, brokers, QHP insurers or others) must enter into a contract with these entities ensuring protection of this information. Non-exchange entities that must independently comply with Health Insurance Portability and Accountability Act data privacy and security requirements (such as QHPs) may be deemed to be in compliance with exchange requirements by virtue of their compliance with HIPAA as long as the HIPAA requirements are at least as protective as the exchange requirement and if the entities also comply with additional ACA data protection requirements.

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The Dangers Of Quality Improvement Overload: Insights From The Field


March 7th, 2014

Editor’s note: This post is also co-authored by Ksenia O Gorbenko, Catherine van de Ruit, and Charles Bosk of the University of Pennsylvania.

Quality improvement (QI) and patient safety initiatives are created with the laudable goal of saving lives and reducing “preventable harms” to patients. As the number of QI interventions continues to rise, and as hospitals become increasingly subject to financial pressures and penalties for hospital-acquired conditions (HACs), we believe it is important to consider the impact of the pressure to improve everything at once on hospitals and their staff.

We argue that a strategy that capitalizes on “small wins” is most effective. This approach allows for the creation of steady momentum by first convincing workers they can improve, and then picking some easily obtainable objectives to provide evidence of improvement.

National Quality Improvement Initiatives

Our qualitative team is participating in two large ongoing national quality improvement initiatives, funded by the Agency for Healthcare Research and Quality (AHRQ). Each initiative targets a single HAC and its reduction in participating hospitals. We have visited hospital sites across six states in order to understand why QI initiatives achieve their goals in some settings but not others. To date, we have conducted over 150 interviews with hospital workers ranging from frontline staff in operating rooms and intensive care units to hospital administrators and executive leadership. In interviews for this ethnographic research, one of our interviewees warned us about unrealistic expectations for change, “you cannot go from imperfect to perfect. It’s a slow process.”

While there is much to learn about how to achieve sustainable QI in the environment of patient care, one thing is certain from the growing wisdom of ethnographic studies of QI: buy-in from frontline providers is essential for creating meaningful change. Front-line providers often bristle at expectations from those they believe have little understanding of the demands of their daily work. Requiring health care providers to improve on all mandated measures at once—in an atmosphere of reduced reimbursements and frequent staff shortages—is a goal that risks burnout, discouragement, and apathy – all signs of initiative fatigue.

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Cesarean Rates: A Global Perspective


February 24th, 2014

As noted in a previous Health Affairs Blog post by Katy Kozhimannil and Ezra Golberstein, there is significant variability in cesarean delivery rates across the United States, but this is also true worldwide. Worldwide cesarean delivery rates have come under scrutiny and criticism since the World Health Organization (WHO) suggested in 1985 that the optimal rate should not exceed 10 to 15 percent.

Although currently there is no expert agreement on a single optimal level, a general consensus has emerged that extremely low rates (less than 5 percent) suggest underuse and higher rates (greater than 10-15 percent) suggest overuse. Globally, the average rate sits slightly above that recommended level at 16 percent. However, the mean value masks the underlying variability that exists across countries and the different issues inherent in the variation. Of countries which report at least some cesarean deliveries, the range of use runs from 1 percent (Niger) to 52 percent (Brazil) of live child births.

Middle and High-Income Countries

Cesarean rates in middle and high-income countries have continued to increase over the last decade (most are significantly over 15 percent). The average rate among the Organisation for Economic Co-operation and Development (OECD)-member countries is 26.9 per 100 live births (range: 14.7 to 49.0). Comparatively, the United States has a very high rate of cesarean delivery (31.4 per 100 live births). In Switzerland, for example, cesarean section rates varied in 2010 from less than 20 percent to over 40 percent in a region. Within a region, the rates also varied by hospital. A study in France found more cesarean sections were performed in for-profit hospitals than in public hospitals, which treat more complicated pregnancies, suggesting that financial incentives may also play a role in explaining excess cesarean deliveries.

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To Pay For Medicare SGR Repeal, Build On Bipartisan Health Care Policy


February 20th, 2014

Something unexpected is happening in Washington. As most eyes track partisan battles over immigration and the Affordable Care Act, key Congressional committees have been quietly advancing truly bipartisan legislation to strengthen Medicare.

Since 2002, an outdated Medicare cost control called the Sustainable Growth Rate (SGR) has repeatedly threatened drastic Medicare provider cuts. After a decade of temporary fixes, SGR repeal appears within reach. A bipartisan, bicameral agreement by key Congressional leaders announced on February 6, 2014 goes a step further by pairing repeal with bipartisan reforms that pay physicians for the quality and value of care they deliver, not the number of tests and procedures they order.

When one of every three health care dollars is wasted on care that does not improve patients’ health, transitioning away from volume-based reimbursement would be momentous. Few policy changes are more fundamental to containing health care costs and protecting the solvency of Medicare.

The challenge in Congress has shifted from getting a bipartisan agreement on new cost controls to paying for the repeal of the old one. The Congressional Budget Office (CBO) estimates the cost of the Senate version of the bipartisan repeal bill at $149 billion over 10 years.

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If A Drug Is Good Enough For Europeans, It’s Good Enough For Us


February 14th, 2014

Note: This post is coauthored by Paul Howard and Yevgeniy Feyman of the Manhattan Institute.

Meningitis is a terrible disease that can kill its victims in a single day. About 4,100 new cases are diagnosed annually in the U.S., with a mortality rate of more than 10 percent. Even with treatment, survivors are often left with serious side effects that can include brain damage and limb loss.

A recent meningitis outbreak at Princeton University was unique, however, because the vaccines typically required by universities don’t protect against the particular strain (serogroup B or “MenB”) of the outbreak. Luckily, Swiss drug manufacturer Novartis has developed a vaccine — Bexsero — that specifically targets this strain of meningitis; the drug has already been approved for use by the European Medicines Agency (EMA), the European Union’s equivalent of the Food and Drug Administration (FDA). And within about nine months the FDA allowed Princeton University to offer the vaccine on campus to its students.

Problem solved, right? Not so fast.

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Connected Health And America’s War On Error


February 5th, 2014

Editor’s note: For more on connected health, see Health Affairs‘ newly published February thematic issue on the subject. The issue was discussed at a Washington DC briefing this morning, keynoted by the new National Coordinator for Health Information Technology, Karen DeSalvo. The Office of the National Coordinator and West Health Institute are cosponsoring a conference tomorrow on developing an interoperable health care system.


recent analysis, the annual losses are worse than any other war in our nation’s history, including the Civil War, World War II and our War on Terror. It is an undeclared “war on error” within our healthcare delivery system. It is the most deadly war we have ever waged, with errors and resultant harm in hospitals contributing to the death of nearly 1,000 people each day in the U.S., potentially more than 400,000 a year.

As with any other war, there is an enormous economic burden. The U.S. spent approximately $2.8 trillion on health care in 2012, with about 30 percent of total health care expenditures attributed to hospital services. That’s just over $800 billion annually, making America’s war on error not only the deadliest, but also the most expensive.

Until now, this war has often been waged in hospitals, where small, poorly outfitted groups of combatants have used simple, unconventional means like prompts for hand washing, autographing surgical sites and implementing ‘no interruption zone’ for medicine preparation – with limited success. But now, new technologies like integrated sensor networks, fully integrated electronic medical records (EMRs), clinical-decision support systems and algorithm-based care, all embedded in smart and learning systems, may finally provide the tools needed to win the war.

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The Hidden Curriculum: Changing The Water In Which We Swim


January 31st, 2014

Editor’s Note: This post is a response to Joshua Liao, Eric Thomas, and Sigall Bell’s essay, “Speaking Up About The Dangers Of The Hidden Curriculum,” published under Narrative Matters in the January issue of Health Affairs.

As the lights in the auditorium go down, just before I flick on my microphone, I remember what media critic Marshall McLuhan once said about culture: We live “in an electric information environment that is quite as imperceptible to us as water is to fish.”

As a leader of my institution’s curriculum redesign effort, I often speak with departments and even the whole faculty about our plans for the new curriculum. These experiences have made me acutely aware of how well McLuhan’s quote applies to what has been called the “hidden curriculum” in medical education. Medical education, and the culture of medicine in which it occurs, influence personal identity and perception so pervasively that it can be a challenge to talk clearly about how to change the hidden curriculum.

Liao and colleagues overcome that challenge in the January issue of Health Affairs, making an eloquent call for better dialogue about how the hidden curriculum can undermine patient safety. They point out, rightly, that, “The difference between what we say we do and what we actually do as doctors and teachers can be stark.” Such verbal disconnects can undermine the culture of patient safety, a dilemma fixed first through awareness and then through the courage to speak up.

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