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What’s Past Is Prologue: Making The Case For PET Beta-Amyloid Imaging Coverage


April 9th, 2014
by Dora Hughes

Editor’s note: This post is published in conjunction with the April issue of Health Affairs, which features a series of articles on Alzheimer’s disease.

In September of 2013, CMS issued its final decision memo that concluded positron emission tomography- amyloid beta (PET Aβ) imaging is “not reasonable or necessary”, finding “insufficient evidence” that use of this diagnostic tool would improve health outcomes for patients with dementia or neurodegenerative disease. As such, PET Aβ imaging to help diagnose Alzheimer’s disease (AD) is not a covered service for Medicare beneficiaries except for those enrolled in CMS-approved clinical trials.

CMS’ final decision underscores the emerging new paradigm for coverage decision-making, requiring innovators not only to demonstrate to FDA’s satisfaction that their products are effective, but also to prove to CMS and other payors that their use will improve clinical outcomes. This paradigm will increase confidence in the value and health benefit of new technologies, although it will make the path to coverage more difficult and uncertain for diagnostic developers.

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Accelerating Medicines Partnership: A New Public-Private Collaboration For Drug Discovery


April 8th, 2014
 
by Aaron Kesselheim and Yongtian Tan

Editor’s note: This post is also coauthored by Yongtian Tan and is published in conjunction with the April issue of Health Affairs, which explores the many subjects raised by Alzheimer’s disease including a new public-private research collaboration designed to produce improved treatments.

Earlier this year, the National Institutes of Health joined forces with ten major pharmaceutical companies and several nonprofit disease interest groups to create the Accelerating Medicines Partnership (AMP). With an integrated governance structure consisting of representatives from all partners, the AMP venture aims to combine public-private expertise and pooled resources to reduce the time and cost of  developing biomarkers for therapeutic targets.

The initial capitalization is reported to be $230 million.  The AMP is the first national cross-sector partnership of its size and scale, and is the latest initiative in the drug development market to embrace open data exchange, encouraging collaboration over competition as pathways for promoting innovation.

The AMP management chose to focus on four diseases—Alzheimer’s disease, type 2 diabetes mellitus, rheumatoid arthritis, and systemic lupus erythematosus—in which there was solid knowledge about the underlying pathophysiology, a sufficient level of potential therapeutic targets open to pursuit, and a lack of substantial individual manufacturer commitment.  The latter criterion explains why more prevalent diseases such as cancer did not make the list.

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Health Affairs Briefing Reminder: Long Reach Of Alzheimer’s Disease


April 4th, 2014
by Chris Fleming

Despite decades of effort, finding breakthrough treatments or a cure for Alzheimer’s has eluded researchers. In the April 2014 issue of Health AffairsThe Long Reach Of Alzheimer’s Disease, we explore the many subjects raised by the disease: the optimal care patients receive and the testing of new models, international comparisons of how the disease is treated, families’ end-of-life dilemmas, a new public-private research collaboration designed to produce improved treatments, and others.

Please join us on Wednesday, April 9, at W Hotel in Washington, DC, for a Health Affairs briefing where we will unveil the issue.  We are delighted to welcome Dr. Richard Hodes, director of the National Institute on Aging at the National Institutes of Health to deliver the Keynote. Read the full briefing agenda.

WHEN:
Wednesday, April 9, 2014
8:30 a.m. – 12:30 p.m.

WHERE:
W Hotel Washington
515 15th Street NW, Washington, DC (Metro Center)
Great Room, Lower Level

 REGISTER ONLINE

Follow live Tweets from the briefing @HA_Events, and join in the conversation with the hashtag #HA_Alzheimers.

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Embarking On A New Journey With Health Affairs


March 31st, 2014
by Alan Weil

I am delighted to be taking on the role of editor-in-chief of Health Affairs. This is a dynamic time in all aspects of health and health care: insurance coverage expansions, delivery system changes, and growing attention to population health.  Building upon thirty-three years of peer-reviewed scholarship, Health Affairs will continue to serve as the nation’s primary resource for the health policy community.

My goals for Health Affairs coalesce around a single theme: broadening the reach of the journal.

Health Affairs is strong in the core health policy community, but our scholarship is relevant to myriad actors in the one-sixth of the United States economy represented by health care.  My goal is to broaden our engagement with the worlds of law, finance, design, and many others.

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Health Policy Leader Alan Weil To Become New Health Affairs Editor-in-Chief


March 31st, 2014
by Chris Fleming

Health Affairs and its publisher Project HOPE are pleased to announce that Alan Weil will become the journal’s new editor-in-chief on June 2, 2014.

Weil, a highly respected expert in health policy and current member of Health Affairs’ editorial board, will lead the journal after serving as the executive director of the National Academy for State Health Policy (NASHP) since 2004. His work with state policymakers of both political parties put Weil at the forefront of health reform policy, implementation, innovation, and practice. Prior to his leadership of NASHP, he served in both the public and private sectors. He directed the Urban Institute’s “Assessing New Federalism” project; served as the executive director of the Colorado Department of Health Care Policy and Financing and a health policy advisor to Colorado’s then-governor, Roy Romer; and was the assistant general counsel in the Massachusetts Department of Medical Security.

“We’re delighted to welcome Alan to the Project HOPE family,” said John P. Howe III, M.D., President and CEO of Project HOPE. “He comes to Health Affairs with more than 24 years of experience in health policy development and a stellar record of leadership and innovation in this field. I’m confident he will lead the journal’s talented staff on a new and successful path forward. I am extremely grateful to John Iglehart, the Founding Editor of Health Affairs for his stewardship of the journal for more than 25 years, ensuring its coveted rank as the leading health policy journal of our time.”

“Alan Weil’s extensive background in health and health care policy will serve him well in his new role as Health Affairs’ editor-in-chief,” noted John Iglehart, who currently leads the journal. “With his position on the front lines of health system change, he is an experienced leader who has deep familiarity with and longstanding connections to the health policy, research, and health care leadership communities. In particular, in his role as NASHP’s executive director, Alan worked on complex issues of critical importance to leaders in state and federal government and the private sector. This background will serve Health Affairs well as it continues to grow in influence both in the US and globally.”

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Health Affairs Briefing: Long Reach Of Alzheimer’s Disease


March 26th, 2014
by Chris Fleming

Despite decades of effort, finding breakthrough treatments or a cure for Alzheimer’s has eluded researchers. In the April 2014 issue of Health Affairs, The Long Reach Of Alzheimer’s Disease, we explore the many subjects raised by the disease: the optimal care patients receive and the testing of new models, international comparisons of how the disease is treated, families’ end-of-life dilemmas, a new public-private research collaboration designed to produce improved treatments, and others.

Please join us on Wednesday, April 9, at W Hotel in Washington, DC, for a Health Affairs briefing where we will unveil the issue. We are delighted to welcome Dr. Richard Hodes, director of the National Institute on Aging at the National Institutes of Health to deliver the Keynote.

WHEN:
Wednesday, April 9, 2014
8:30 a.m. – 12:30 p.m.

WHERE:
W Hotel Washington
515 15th Street NW, Washington, DC (Metro Center)
Great Room, Lower Level

REGISTER ONLINE

Follow live Tweets from the briefing @HA_Events, and join in the conversation with the hashtag #HA_Alzheimers.

Read the rest of this entry »

PCORI’s Research Will Answer Patients’ Real-World Questions


March 25th, 2014
by Joe Selby

As a physician, I know the challenge of helping patients determine which health care options might work best for them given their personal situation and preferences. Too often they — and their clinicians — must make choices about preventing, diagnosing and treating diseases and health conditions without adequate information. The Patient-Centered Outcomes Research Institute (PCORI) was created to help solve this problem — to help patients and those who care for them make better-informed health decisions.

Established by Congress through the Patient Protection and Affordable Care Act as an independent research institute, PCORI is designed to answer real-world questions about what works best for patients based on their particular circumstances and concerns. We do this primarily by funding comparative clinical effectiveness research (CER), studies that compare multiple care options. But more research by itself won’t improve clinical decision-making. Patients and those who care for them must be able to easily find relevant evidence they can trust. That’s why our mandate is not just to fund high-quality CER and evidence synthesis but to share the results in ways that are meaningful to patients, clinicians and others. We’re also charged with improving the methods used in conducting those studies and enhancing our nation’s capacity to do such research.

We will be evaluated ultimately on whether the research we fund can change clinical practice and help reduce the variations and disparities that stand between patients and better outcomes. We’re confident that the work we’re funding brings us and the audiences we serve closer to that goal.

Recently, some questions have been raised in health policy circles about our holistic approach to PCORI’s work. That view holds that direct comparisons of health care options — especially those involving high-priced interventions — should be the dominant if not sole focus of PCORI’s research funding approach as a path to limiting the use of expensive, less-effective options.

We agree that discovering new knowledge on how therapies compare with one another is a critical mandate of PCORI and is essential to improving the quality and effectiveness of care. However, ensuring that patients and those who care for them have timely access to and can use this knowledge, so that they can effectively apply it to improve their decisions, is also very important. That is the reasoning behind our integrated approach path that addresses the gaps in available evidence, and also studies how best to make the evidence available and usable.

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The Health Workforce: A Critical Component Of The Health Care Infrastructure


March 24th, 2014
by Edward Salsberg

Editor’s note: This is the first in a periodic series of Health Affairs Blog posts on health workforce issues by Edward Salsberg. Mr. Salsberg has spent over 30 years studying the health workforce, including nearly 20 years establishing and directing three centers dedicated to workforce data collection, analysis and research. The first center, at the University at Albany, was focused on state health workforce data collection and issues. The second, at the Association of American Medical Colleges, was focused on the physician workforce across the nation. The third, the National Center for Health Workforce Analysis, was authorized by the Affordable Care Act. Mr. Salsberg has now joined the faculty at George Washington University where they are establishing a new Center for Health Workforce Research and Policy.

In the post below, Mr. Salsberg provides an overview of workforce issues. Future posts will discuss more specific health workforce questions and developments.

It could be argued that the health workforce — the people who provide direct patient care, as well as the staff that support caregivers and health care institutions — is the most significant component of the infrastructure of the health care system. Yet as a nation we have invested very little in collecting and analyzing health workforce data or in supporting the necessary research to inform effective public and private decision making. The results of this lack of investment are surpluses and shortages, significant mal-distribution, and less efficient and effective care than would be possible with better intelligence on our workforce needs.

For many health care professions, it takes years to build education and training capacity to increase, supply, or to change curriculum and modify the profession’s skill set. For these professions, we need to not only assess today’s needs but to project our future needs.

What the nation needs is a system to provide data, research findings, and information to thousands of individual stakeholders. This includes individuals considering a health career; colleges, universities and training programs that will educate and prepare them; the health organizations who will employ them; policy makers who need to decide what, if any, programs and policies to support; and the private sector that needs to decide whether to invest in workforce development. The responsibility for assuring an adequate supply and a well prepared health workforce is shared between the public and private sectors at both the national and the state and local level. Regardless of who is making the decisions related to health professions education and training capacity and health professions preparation, accurate and timely data is extremely important to support informed decisions.

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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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How Will California’s Penal System Respond To The ‘Perfect Storm’?


March 7th, 2014
by Jonathan Simon

Editor’s note: In addition to Jonathan Simon (photo and bio above), this post is coauthored by Daniel Mistak, a graduate student in Jurisprudence and Social Policy at the University of California, Berkeley. He previously earned his juris doctorate from University of California, Berkeley, School of Law. Prior to law school he attained a master’s degree in philosophy, with a focus in bio-ethics, and a master’s degree in genetics and cell biology. This post is published in conjunction with the March issue of Health Affairs, which features a cluster of articles on jails and health.

California’s system of incarceration is in the midst of sweeping changes. Recent shifts in state and federal law, motivated and bolstered by Supreme Court decisions, have created a perfect storm for institutional change. But as with any storm, it can be difficult to predict what can be done to prepare and what will be left when the clouds clear.

What caused this perfect storm in California? In 2011, the Supreme Court found in Brown v. Plata that California’s prisons could not meet the mental and physical health needs of the inmates because of prison overcrowding. To avoid violating the VIII Amendment’s prohibition on cruel and unusual punishment, the Court mandated that California prisons decrease their over-crowded prison populations to 137.5 percent of their design capacity within two years. Governor Jerry Brown signed into law Assembly Bill 109 (‘Realignment’) to facilitate this transition.

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How Many Nongroup Policies Were Canceled? Estimates From December 2013


March 3rd, 2014
 
by Lisa Clemans-Cope and Nathaniel Anderson

Editor’s note: This post is co-authored by Lisa Clemans-Cope and Nathaniel Anderson of the Urban Institute.

Last fall, news reports focused on consumer discontent over “cancellation” notices of health insurance policies that did not meet the new minimum standards under the Affordable Care Act (ACA), but it’s difficult to determine exactly how many consumers were affected.  Starting in 2014, most non-group health insurance plans and small employer group plans must offer a minimum set of benefits and consumer protections—for example, plans must not exclude coverage of pre-existing conditions and must offer minimal coverage of certain health benefits such as prescription drugs.

Prior to reform, the nongroup health insurance market suffered from a number of shortcomings, such as benefit exclusions, denials of coverage, premiums that varied greatly by health status, benefit limits, high cost-sharing, and lack of information on plan benefits and design prior to purchase. The new minimum benefit standards and consumer protections work together with additional insurance market provisions that took effect in 2010, expansions of Medicaid eligibility, and income-based subsidies in the new health insurance Marketplaces. Together, these new reforms expanded coverage options for millions of people, and raised minimum benefits and consumer protections for millions more.

Among nongroup plans offered in 2013 that were not compliant with ACA standards, some were amended, some were cancelled, and some were granted “grandfathered” status and are not required to comply with the new rules if enrollees were holding the policy continuously before and since the passage of the ACA and insurers did not substantially change benefits or costs. Some insurers, however, chose to cancel policies that would otherwise have been legally grandfathered for business reasons, such as low enrollment or an enrollee group with high average cost, leading to unsustainable premiums. In fact, the non-group market has historically been highly volatile, with just 17 percent retaining coverage for more than two years.

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Jeffrey Brenner On GrantWatch: The Future For Population Health


February 21st, 2014
by Tracy Gnadinger

In a recent GrantWatch Blog post, Jeffrey Brenner raises the question, “What if Thomas Edison had to write grant proposals to invent the light bulb?” Brenner is a MacArthur fellow, medical director of the Urban Health Institute, and executive director and founder of the Camden Coalition of Healthcare Providers.

Brenner uses the Edison analogy to look at current grant funding and population health.

Since 1945 the National Institutes of Health (NIH), a federal government agency that funds medical research, has spent $547 billion dollars to cure disease and push the frontiers of medical knowledge. This spending has been supplemented by funding from private foundations. Sadly, despite all of this spending we have little understanding of how to deliver better care at lower cost to every American. At best, in the field of population health, we have a few light bulbs that stay lit for an hour or two, but we lack even basic knowledge to drive this field forward.

With 85 million baby boomers in the midst of retiring and a health care system that consumes 18 percent of our economy, it is not a small problem. We do not understand the fundamental drivers of health care utilization; the basic rules for designing and implementing effective interventions; the best ways to use data to plan, implement, manage, and evaluate interventions; nor how to train staff to run and lead these interventions. Why the lack of progress?

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The Need For A Smart Approach To Big Health Care Data


January 27th, 2014

Today, academic medicine and health policy research resemble the automobile industry of the early 20th century — a large number of small shops developing unique products at high cost with no one achieving significant economies of scale or scope. Academics, medical centers, and innovators often work independently or in small groups, with unconnected health datasets that provide incomplete pictures of the health statuses and health care practices of Americans.

Health care data needs a “Henry Ford” moment to move from a realm of unconnected and unwieldy data to a world of connected and matched data with a common support for licensing, legal, and computing infrastructure. Physicians, researchers, and policymakers should be able to access linked databases of medical records, claims, vital statistics, surveys, and other demographic data. To do this, the health care community must bring disparate health data together, maintaining the highest standards of security to protect confidential and sensitive data, and deal with the myriad legal issues associated with data acquisition, licensing, record matching, and the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Just as the Model-T revolutionized car production and, by extension, transit, the creation of smart health data enclaves will revolutionize care delivery, health policy, and health care research. We propose to facilitate these enclaves through a governance structure know as a digital rights manager (DRM). The concept of a DRM is common in the entertainment (The American Society of Composers, Authors and Publishers or ASCAP would be an example) and legal industries.  If successful, DRMs would be a vital component of a data-enhanced health care industry.

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Measuring Quality of Care for Older Adults With Serious Illness


January 22nd, 2014

Editor’s Note: This post is the third in a periodic Health Affairs Blog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on an upcoming volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value. This post describes the Advanced Care model, a delivery system approach that includes palliative care and coordinates services for people with serious chronic illness across hospitals, medical groups, homes, and the community.

In the United States, value is the new health care imperative – improving quality while controlling costs.  We spend nearly twice the rate of comparable nations, yet have poorer health outcomes.  In 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA), mandating a new emphasis on paying for value, not volume.

Our greatest opportunity to enhance value in US health care is to improve quality of care for older adults with serious illness – the group who uses the most health care services. Serious illness, in which patients are unlikely to recover, stabilize, or be cured, is life-altering for patients and family caregivers.  It includes advanced, symptomatic stages of diseases such as congestive heart failure, chronic lung disease, cancer, kidney failure, and dementia. Serious illness may also refer to the cumulative consequences of multiple conditions progressing over time, causing functional decline or frailty.

We’ve made important progress in understanding high quality care for this population of patients.  Researchers have asked patients with serious illness and their families how they define high quality care.  Especially in serious illness, patients want control over treatment through shared decision-making.   Even when there is no cure, most patients still want health care that helps them live longer – but only if they can also get help with function, physical comfort, and attention to family, emotional and spiritual needs.

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Nursing Homes Are The Solution On Readmissions


January 17th, 2014
by David Gifford

A recent report from the Office of the Inspector General (OIG) within the Department of Health and Human Services (HHS) argues that skilled nursing care centers, or “nursing homes,” should be better monitored by the federal government when it comes to how frequently they send patients back to the hospital. OIG recommended that the Centers for Medicare and Medicaid Services (CMS) develop a quality measure to track and publicly report nursing centers’ hospitalization rates and to have state survey agencies review the measure as part of the survey and certification process. As the largest association representing skilled nursing care centers in the country, the American Health Care Association (AHCA) agrees. In fact, we do not think OIG goes far enough. We support linking Medicare payments to skilled nursing care centers based on their hospital readmission rates.

Frequent trips to the hospital are disrupting to seniors and put them at greater risk for complications and infections. It is also costly to the system, as the OIG report demonstrates. AHCA came to the same conclusion and is already acting on the issue. AHCA wrote to Congress earlier this year in support of measuring and publicly reporting hospitalization rates among skilled nursing centers when the legislative body requested comments on how to reform Medicare post-acute care payments.

We also support the expansion of CMS’ new inspection process, the Quality Indicator Survey (QIS), which includes a process to review a center’s hospitalization rates unlike the old survey process. However, only 26 states presently use the QIS process after CMS suspended nationwide implementation due to potential budget constraints. AHCA supports CMS continuing its expansion of the QIS to all states as designed, which will have surveyors review centers’ hospitalization rates as recommended by the OIG.

We’re not just encouraging measuring and reporting; we have also developed a hospitalization measure, which we have shared with the federal government. AHCA partnered with the data analytics company, PointRight, to calculate risk-adjusted hospital readmissions during the first 30 days of a skilled nursing stay. Previously, this data was not available to individual providers and was not risk adjusted. Instead, it was reliant on Medicare claims data which did not account for individuals covered by other insurance such as Medicaid, managed care, commercial insurance, or private pay, and resulted in a two-year lag time before data were available.

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A Policy Dialogue On Connected Health


December 19th, 2013
by Janet Marchibroda

Editor’s note: In addition to Janet Marchibroda (photo and linked bio above), this post was coauthored by Chris Fleming, Health Affairs Blog Editor.

What is telehealth or “connected health”? What is driving the use of connected health and what are its benefits? To achieve its full potential, what key challenges must be overcome? What are the central policy issues that must be addressed?

These are some of the questions explored by a group of leaders representing providers, payers, research and philanthropic organizations, and technology companies (listed at the end of this post), convened by Health Affairs and the Bipartisan Policy Center (BPC) last month. The session was organized partly to prepare for an upcoming Health Affairs thematic issue on connected health, to which former Senate Majority Leader and BPC Health Project Co-Chair Bill Frist—who chaired the discussion—will contribute.

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The Laboratory Of War: How Military Trauma Care Advances Are Benefiting Soldiers And Civilians


December 18th, 2013

Editors note: This morning, in Bethesda MD, the Executive Director of the American College of Surgeons, Dr. David Hoyt, presented the leadership of Walter Reed National Military Medical Center with a plaque recognizing its designation as an ACS-certified Level II Trauma Center. Walter Reed Bethesda is part of extraordinary chain of military health system facilities, providers, organizations, and techniques that have dramatically improved an injured service member’s odds of survival and recovery. As the authors of this post note, lessons learned during more than a decade of war are now being adopted into civilian care, to the benefit of children and adults in every corner of the United States and beyond. For more on emergency care, read the December Health Affairs issue, “The Future of Emergency Medicine: Challenges And Opportunities.

Out of the ashes of 9-11 and the two wars that followed, a new paradigm has emerged that has benefited more than 50,000 injured warfighters and is transforming civilian trauma care. During the past decade of war, strategic investments in research and clinical care, coupled with contributions from world-class clinician-scientists, have produced the lowest case-fatality rate among combat casualties in the history of armed conflict.

At the beginning of Operations Enduring Freedom (OEF) and Iraqi Freedom (OIF), the combat injury case-fatality rate was approximately 18 percent. Over the subsequent decade, it steadily decreased to 5 percent despite an overall increase in injury severity. This remarkable achievement is grounded in advances in all aspects of trauma care, from the point of injury to optimum treatment in military rehabilitation centers.

As with all previous conflicts throughout history, clinical knowledge generated in the civilian setting was rapidly adapted in innovative ways to address challenges encountered on the battlefield. Now, it is coming full circle to improve the care and decrease the mortality of both injured warriors and civilian trauma victims. This reciprocal relationship between military and civilian medicine, recently highlighted in domestic terrorism attacks such as the Boston Marathon bombing and the mass shootings at Aurora and Tucson, is visible in daily practice in trauma centers throughout the country.

These improvements didn’t happen by accident; the military invested in relevant translational research and developed a flexible, evidence-based trauma system that rapidly developed, assessed, deployed, and refined new advances in trauma care and rehabilitation. In this post we highlight a number of these advances and the science behind them, and we offer a roadmap to ensure that these advances are not only preserved for use in future conflicts, but evolve to benefit all patients — military and civilian alike.

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Health Care Reform: Views From The Hospital Executive Suite


December 18th, 2013

Pessimism pervades the national dialogue surrounding healthcare reform. Despite fixes to the federal exchange website and marked improvements in enrollment, politicians and pundits continue to assail the Affordable Care Act (ACA), offering grim predictions about the future of healthcare after its implementation. The law, they claim, is an unworkable train-wreck. It will produce a healthcare system with significantly higher costs, lower quality, and bureaucratic confusion.

The public has seemed equally pessimistic. Fifty-four percent of Americans, according to a recent poll, believe the ACA will have a negative impact on the healthcare system, compared to only 24 percent who anticipate a positive impact. Nearly three-quarters expect the quality of healthcare to decline or stay the same, while only 11 percent expect it to improve. More than half expect costs to rise while only 9 percent expect them to fall.

Such pessimism, however, is hardly a credible predictor of the success or failure of the ACA. Politicians, pundits, and the public are largely removed from the inner workings of the healthcare system, so it is difficult for them to form an accurate, 360-degree view of reform. Moreover, most Americans (70 percent) readily admit they know little about the ACA or its potential impact.

A more meaningful source for an appraisal of healthcare reform, and for predictions about how it will fair, would be individuals who are especially informed—people who have spent their entire careers on the front lines of the healthcare system deciding how budgets are managed and how care is delivered—people like the leaders of America’s hospitals and health systems. Healthcare reform is catalyzing major changes for these executives and their institutions. Wouldn’t it be helpful to know if they share the public’s apprehension and pessimism?

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Managing Off-Label Drug Use


December 17th, 2013
by Marc Rodwin

The Food and Drug Administration (FDA) authorizes the marketing of drugs only for uses that the manufacturer has demonstrated to be safe and effective. However, the FDA does not regulate medical practice, so physicians may prescribe drugs in ways that deviate from the uses specified in the FDA-approved drug label and marketing authorization, a practice referred to as off-label prescribing. This practice includes prescribing for a different therapeutic purpose, using a different dose or a different duration of use, using a different mode of administration than the one indicated on the label, and prescribing the drug for patients in a different age cohort or gender than the population on which it was tested.

Off-label prescribing makes clinical sense only in exceptional circumstances. If reasonable evidence suggests that the benefit of off-label use will outweigh the risks, that declining to treat the condition poses even greater dangers than the off-label prescription does, and that there is no adequate alternative therapy, then off-label prescribing can benefit patients. However, physicians prescribe off-label much more frequently than is justifiable: seventy percent of off-label uses lack significant scientific support. They risk harming their patients without producing therapeutic benefit.

Physicians value the right to prescribe off-label. Insurers that reimburse such prescriptions make it feasible for patients to purchase the drugs. But it is the pharmaceutical firms’ incentive to increase sales that drives this practice. More sales increases profits, whether the drugs are used as approved or off-label, so manufacturers have powerful incentives to promote off-label use and none to discourage it. Their strategies to promote off-label use are often legal and recent court decisions have made it even easier for them by expanding the scope of activities deemed to be commercial speech protected by the First Amendment. But manufacturers also have incentives to engage in illegal promotion when the expected revenue exceeds any penalties.

Unmanaged off-label drug use compromises sound medical practice and undermines the FDA’s mission of protecting patients by regulating the drug market. Yet public policy fails to track, evaluate, or oversee off-label drug use. Typical reform proposals, such as increased sanctions for illegal off-label promotion, might reduce unjustified off-label use, but addressing the source of the problem would require the following steps. Prescriptions must be tracked to identify and oversee off-label prescribing. Reimbursement rules must change so that manufacturers cannot profit from off-label sales. Manufacturers must pay for independent evaluation of off-label uses when off-label sales pass a critical threshold.

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Applying Comparative Effectiveness Research To Individuals: Problems And Approaches


October 29th, 2013
by Joel Kupersmith

A Comparative Effectiveness Research (CER) study shows that surgery is better than medical treatment for a particular cardiac condition. My patient is 78 years old and has complicated diabetes. – does the study apply? Another patient 48 years old and otherwise healthy. Does it apply here?

Can the overall results of a CER study be applied to all patients in the target population? Are there substantial, undetected variations among patients in the results of CER? What is the extent of exceptions? These are important policy questions in applying results of CER to day-to-day decisions, clinical guidelines, performance measures and other facets of the modern healthcare system.

The “gold standard” approach to CER is the randomized (RCT), a scientific comparison of two or more clinical strategies, with the downsides that it is generally conducted in a special environment and usually has a rather narrow (and possibly unrepresentative) population spectrum. Two variants, the Practical (or Pragmatic) Clinical Trial (PCT) and the Large Simple Trial (LST) are inclusive of a wider spectrum of patients and more diverse clinical settings.

These approaches provide “average” results and for the most part it is thought that averages do apply to a large segment of the population at large for which they are intended. However, there are clearly differences in effect (heterogeneities of treatment effect – HTE’s) that manifest among CER study subjects and presumably to a greater extent in the intended population outside the study. Two approaches may be equivalent on the average but one may be better in a particular group, and differences may be less apparent when the study’s population base is narrow. A long list of factors contribute to these HTEs for CER and other trials – comorbidities, severity of illness, genetics, age, medication adherence, susceptibility to adverse events, ethnicity, site, economics and others.

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