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Investing In The Health And Well-Being Of Young Adults


December 15th, 2014

Young adulthood — ages approximately 18 to 26 — is a critical time in life. What happens during these years has profound and long-lasting implications for young adults, and — because many are parents — for the next generation.  Healthy, productive, and skilled young adults are critical for the nation’s workforce, global competitiveness, public safety, and national security.

Although young adults are resilient and adaptable, they are surprisingly unhealthy, showing a worse health profile than both adolescents and adults in their late 20s and 30s. Recent national attention on young adults has focused primarily on enrolling them in health care insurance to offset the higher costs associated with care for older adults under the Affordable Care Act 2010 provisions — mistakenly implying that it is not in their own interest to have health insurance. Unfortunately, too little attention has been paid to young adults’ specific health needs and the transitions they face once they are in the health care delivery system.

The Institute of Medicine and National Research Council recently released a new report titled Investing in the Health and Well-Being of Young Adults, which reviews what is known about the health, safety, and well-being of young adults and offers recommendations for policy and research. It was prepared by a committee with expertise in multiple disciplines, including public health, health care, behavioral health, sociology, social services, human development, neuroscience, economics, business, occupational health, media, and communications. We served as chair and a member of the committee, respectively.

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The Innovation Conundrum In Health Care


December 12th, 2014

Editor’s note: This post is part of a series of several posts related to the 4th European Forum on Health Policy and Management: Innovation & Implementation, to be held in Berlin, Germany on January 29 and 30, 2015. For more information or to request your personal invitation contact the Center for Healthcare Management.

It is never too early for new technology in health care. In contrast to the innovator’s dilemma in other industries where the adoption can be sluggish because current customers may not be able to use the future’s toolbox, in medicine innovators always can be assured of an audience when announcing the “life-saving impact” of something new.

Coverage and widespread implementation usually are a different story, but creating hype and demand for unusual and unfamiliar medical technology has never been hard. But who then drives the invention, diffusion, application, and evaluation of such innovation?

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CMS Proposes Coverage For Lung Cancer Screening With Low Dose CT


December 9th, 2014

On November 11, the Centers for Medicare and Medicaid Services (CMS) released its Proposed Decision Memo for Screening Lung Cancer with Low Dose Computed Tomography (LDCT), which is expected to be finalized in mid-December. Despite a negative assessment by its own advisory committee, CMS has proposed coverage with evidence development (CED) for an annual “lung cancer screening counseling and shared-decision-making visit” and, for appropriate beneficiaries, additional screening with LDCT.

Under CED, Medicare provides conditional coverage for a new treatment or technology while additional data is collected to confirm its effectiveness and make a final determination. Through this proposed decision, CMS has followed the lead of numerous other expert and advisory groups, which have concluded that the overall benefits of such screening for at-risk individuals outweigh concerns regarding gaps in evidence, generalizability and potential harms.

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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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Health Affairs Event Reminder: Children’s Health


December 4th, 2014

Threats to children’s health have changed dramatically over the past few generations, but America’s health care system has been slow to transform to meet children’s evolving needs. The December 2014 thematic issue of Health Affairs examines the current state of children’s health, health care delivery, and coverage.

You are invited to join us on Monday, December 8, at a forum featuring authors from the new issue at the National Press Club in Washington, DC.  Panels will cover financing, delivery, access, and the social determinants of children’s health, and spotlight innovative programs that are making a difference.

WHEN: 
Monday, December 8, 2014
9:00 a.m. – 12:30 p.m.

WHERE: 
National Press Club
529 14th Street NW
Washington, DC, 13th Floor

REGISTER NOW!

Follow live tweets from the briefing @Health_Affairs, and join in the conversation with #HA_ChildHealth. 

See the full agenda. Among the confirmed speakers are:

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Takeaways From Health Affairs’ Twitter Chat With PCORI


November 26th, 2014

Recently, we at Health Affairs hosted our first Twitter chat with the Patient Centered Outcomes Research Institute (PCORI) on patient engagement in research. The chat was a follow-up to the Health Affairs patient engagement issue and the recent release of three videos, produced in partnership with PCORI, on the ways patients and practitioners are incorporating patient engagement in health care decisions. The videos are hosted and reported by journalist John Dimsdale.

During the Twitter chat, we moderated a question-and-answer session with PCORI’s director of patient engagement, Sue Sheridan, while many users joined in the conversation with #PatientHC. So what does patient engagement in research look like (question courtesy of the National Partnership for Women and Families)? PCORI responded with the following tweet: “Should engage early and often, but it is not one size fits all,” and then referenced their engagement rubric.

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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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Health Affairs December Briefing: Children’s Health


November 24th, 2014

Threats to children’s health have changed dramatically over the past few generations, but America’s health care system has been slow to transform to meet children’s evolving needs. The December 2014 thematic issue of Health Affairs examines the current state of children’s health, health care delivery, and coverage.

You are invited to join us on Monday, December 8, at a forum featuring authors from the new issue at the National Press Club in Washington, DC.  Panels will cover financing, delivery, access, and the social determinants of children’s health, and spotlight innovative programs that are making a difference.

WHEN: 
Monday, December 8, 2014
9:00 a.m. – 12:30 p.m.

WHERE: 
National Press Club
529 14th Street NW
Washington, DC, 13th Floor

REGISTER NOW!

Follow live tweets from the briefing @Health_Affairs, and join in the conversation with #HA_ChildHealth. 

Read the rest of this entry »

Medicare, Medicaid, And Pharmaceuticals: The Price Of Innovation


November 20th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.

Through much of the last half century, Medicare and Medicaid (MM) have not for the most part supported research intended to lead to new drugs. For their role in drug development, we need to look to infrastructure and incentives. The record of the National Institutes of Health (NIH) illustrates the potential of both for pharmaceutical innovation. The current budget of NIH, the big elephant in the zoo of the federal biomedical enterprise, is $30 billion, but apart from a dozen small programs devoted to targeted drug development, most of these billions are not aimed directly at pharmaceutical innovation (See page 234).

Yet the NIH investment in biomedicine has indirectly fueled drug development in the private sector to a huge degree. It has paid for the training of biomedical scientists and clinicians, many of whom went on to staff the drug industry, especially its laboratories. NIH-sponsored research has also generated basic knowledge and technologies and it has encouraged universities to spin out their potentially useful findings into the industry by allowing for the patenting and licensing of the findings.

Like NIH, MM has helped fuel drug development indirectly by supporting selected experimental cancer treatments, medical education, and some clinical research and training. But investment in these activities has been small and their impact on drug development apparently very limited. In contrast to NIH, the MM stimulus to drug innovation has resided not in the production of new scientists or the patented uses of new knowledge, but principally in markets and pricing.

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Continuity Of Care For Chronic Conditions: Threats, Opportunities, And Policy


November 18th, 2014

Continuity of care is a bedrock principle of the patient-doctor relationship and is believed to be a fundamental attribute of high-quality medical care. Mounting evidence suggests that continuity of care for patients with chronic conditions prevents hospitalizations, reduces health care costs, and may prolong life in some populations.

Because patients are most likely to have longitudinal relationships with their pediatricians, family physicians, and internists, taken together, these primary care doctors are integral to translating continuity into meaningful care coordination. However, within the rapidly shifting landscape of health care delivery in the United States, continuity of care is simultaneously threatened and promoted by emerging care models.

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Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process


November 17th, 2014

The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over three decades ago.

However, widespread criticism of BPCIA provisions to facilitate interactions between biosimilar applicants and reference biologic sponsors regarding application submission and patent status was swift and unrelenting. Attorneys practicing in the realm of Hatch-Waxman litigation for generic drugs balked at the drastic differences between the familiar public process grounded in required patent disclosures, FDA Orange Book listings, and generic applicant certifications and the private, iterative process set forth in the BPCIA. Legal scholars, industry representatives, and practitioners alike projected that a courtroom battle regarding real-world operation of the provisions was imminent.

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Health Affairs Twitter Chat With PCORI


November 12th, 2014

Health Affairs recently partnered with the Patient Centered Outcomes Research Institute (PCORI) to produce three videos about ways patients and practitioners are incorporating patient engagement in health care decisions. The videos are hosted and reported by journalist John Dimsdale.

Twitter Chat On Patient Engagement

To further the conversation, Health Affairs and PCORI will host a Twitter chat with Sue Sheridan, director of patient engagement for PCORI, on Monday, November 17 at 2 p.m. ET on the topic of patient engagement in research.

Monday, November 17
2-3 p.m. ET
Join the conversation using #PatientHC!

Join in the conversation with the hashtag #PatientHC and follow us @Health_Affairs. Have a question about patient engagement in research? Send it along using #PatientHC.

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Addressing The Threat Of Antibiotic Resistance: Policy Solutions To Fix A Broken Pipeline


November 6th, 2014

Recently, the White House released a major new national strategy to combat antibiotic resistance. As efforts begin to translate that unprecedented announcement into action, it is critical that any strategy to address resistance contain a plan to ensure an adequate antibiotic development pipeline. The overall number of antibiotics reaching the market has declined over time, with 29 and 23 new antibiotics approved in the U.S. in the 1980s and 1990s, respectively, but only nine between 2000 and 2010.

Meanwhile, the evolution of drug-resistance has outpaced the development of new antibiotics. Doctors routinely encounter patients with infections that do not respond to currently available treatments. Some life-threatening infections, such as those caused by carbapenem-resistant Enterobacteriaceae, or CRE, are resistant to nearly all available therapies. The Centers for Disease Control and Prevention estimates that in the United States at least two million people are sickened by resistant bacteria each year and 23,000 die as a result.

Current State of Antibiotic Development

In order to better understand the pipeline and evaluate policies to spur antibiotic development, the Pew Charitable Trusts has identified antibacterial drugs in clinical development (Phases 1-3) for the U.S. market. Published on our website and updated quarterly, this resource provides policymakers, the medical community, and industry stakeholders with an up-to-date picture of drugs in development.

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Lessons from Ebola: The Infectious Disease Era, And The Need To Prepare, Will Never Be Over


October 28th, 2014

With the wall-to-wall news coverage of Ebola recently, it’s hard for many to distinguish fact from fiction and to really understand the risk the disease poses and how prepared we are to fight it.

Fighting infectious diseases requires constant vigilance. Along with Ebola, health officials around the globe are closely watching other emerging threats: MERS-CoV, pandemic flu strains, Marburg, Chikungunya and Enterovirus D68. The best defense to all of these threats is a good offense — detecting, treating and containing as quickly and effectively as possible.

And yet, we have consistently degraded our ability to respond to these new, emerging and re-emerging threats by underfunding and undercutting existing capabilities and expecting the country to ramp up overnight when new threats emerge.

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How Engaging Patients Can Improve Care And Health Outcomes


September 26th, 2014

Patients and caregivers are gaining momentum as powerful new resources in efforts to improve the health care system. They are increasingly becoming active partners in their own care, as well as seeking to make the health care delivery system more responsive to their needs and easier to navigate. And they are increasingly engaging as collaborators in planning and conducting research, and disseminating its results, with the goal of producing evidence that can help patients and those who care for them make better-informed decisions about the clinical choices they face.

It is this last trend that led the Patient-Centered Outcomes Research Institute (PCORI) to support Health Affairs in developing a series of videos illustrating some of the ways that patients are bringing their unique experiences and community connections to efforts to improve care for themselves and others. This includes stories of how patients are becoming partners in research designed to address the outcomes important to them, taking account of their own concerns and circumstances.

Seen through this lens, being a research partner goes well beyond being the subject of a trial. Rather, it means helping to guide researchers in formulating the questions to be studied, making the right clinical comparisons, looking at appropriate populations, and focusing on the outcomes important to patients. This should greatly increase the chance that the research findings will produce relevant results that can have a real-world impact — something we plan to evaluate carefully over time.

Meaningful patient engagement is at the heart of PCORI’s approach to research, and several of the patients featured in the videos have in fact partnered with researchers in just this way in patient-centered outcomes research (PCOR) studies we fund. They recognize that PCOR, a form of comparative clinical effectiveness research that focuses on issues of concern to patients, is a vital building block for developing truly patient-centered care and health policy, more effective treatments, and better outcomes.

In the following sections, we highlight the projects mentioned in the videos to give you an idea of how patients and community members are partnering in research projects.

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Global Health Update: High Bed Occupancy Rates And Increased Mortality In Denmark


September 24th, 2014

High levels of bed occupancy are associated with increased inpatient and thirty-day hospital mortality in Denmark, according to research recently published in the July issue of Health Affairs.

Authors Flemming Madsen, Steen Ladelund, and Allan Linneberg received considerable media attention in Denmark for their research findings. For one major Television channel, it topped Germany’s victory in the World Cup finals.

In another story from the Danish newspaper, Information, Councillor Ulla Astman, Chairman of the North Denmark Regional Council and second highest ranking politician, who runs all of the Danish public hospitals, reportly stated that “we have to live with it [the increased mortality],” since they cannot afford to reduce bed occupancy.

“Or die with it,” said lead author Madsen, a pulmonary physician and director of the Allergy and Lung Clinic in Helsingør, Denmark, at the July 9 Health Affairs briefing, “Using Big Data To Transform Care.” Madsen, who left his position as director of the Department of Internal Medicine at Frederiksberg Hospital in Copenhagen to pursue this research, believes that Astman’s statement explains why they have a bed shortage problem and supports his argument that bed shortage is a result of planning.

“It is dangerous to focus on productivity without looking at the consequences,” says Madsen.

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Should We Be Done With Describing Health Disparities?


September 17th, 2014

A recent Health Affairs podcast featured a conversation with AcademyHealth president and CEO Lisa Simpson on health disparities along with Darrell Gaskin, the lead of one of the panel sessions at the 2014 National Health Policy Conference (NHPC), “Community Health and Disparity: Moving Beyond Description.” The conversation endorses interventions rather than descriptions as the future direction of health disparities research.

But should we be done with describing health disparities? In a paper we recently published online in the International Journal for Equity in Health, we show that the answer is: Not entirely.

In this paper, using large, publicly available data, 2008, 2009, and 2010 Behavioral Risk Factor Surveillance System (BRFSS) Selected Metropolitan/Micropolitan Area Risk Trends (SMART) and 2008, 2009, and 2010 United States Birth Records from the National Vital Statistics System, we reported education-, sex-, and race-related disparities in four health outcomes (poor/fair health, poor physical health days, poor mental health days, and low birthweight) in each of the selected 93 counties in the United States representing about 30 percent of the U.S. population.

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Advancing Innovation To Eliminate Health Disparities


September 4th, 2014

The advent of population health management, community-based care coordination and mobile health technologies provide a promising opportunity to address longstanding and persistent health disparities. Separately each adds a new dimension to research and analysis, and to individual and community-level public health prevention and access to quality care. Together, providers, payers and researchers alike can acquire a richer understanding of contextual, environmental, and behavioral factors that contribute to disparate outcomes in health.

Existing innovations in data capture, epidemiologic profiling, clinical translation, and workforce development have yet to be taken to scale or appropriately deployed in a manner that would benefit vulnerable populations. Meaningful use technologies, for example, appear to be stuck in the proverbial pipeline with resistance in uptake and limited distribution of incentives. Meaning access and application in poor and disparate communities where they are more often subjects of research and not partners in innovation is far off.

What public health, and community-based and clinically focused interventions need is a fresh look at how health disparities are measured and the processes for application of solutions to needy populations.

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The Winding Path To Effective Bundled Payment


August 28th, 2014

Tom Williams and Jill Yegian’s excellent blog post makes a great companion to our recent paper on the evaluation of the Integrated Healthcare Association (IHA) Bundled Payment Demonstration. Williams and Yegian offer lessons from their experience implementing a demonstration project that failed to meet its original objectives. This type of analysis is essential.

It’s not unusual for a demonstration to fall short of its original objectives. Learning from such cases is part of the innovation process. This is especially worthwhile for bundled payment, which has many potential benefits for patients, providers, and payers.

None of the barriers encountered in IHA’s demonstration signal a “death sentence” for bundled payment. However, the demonstration clearly shows that bundled payment is difficult to implement.

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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era


August 27th, 2014

The Development of Brincidofovir and its Possible Use to Treat Josh Hardy

Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.

His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. They were aware of another anti-viral in Phase 3 clinical development, brincidofovir, an oral compound chemically related to Vistide. In earlier clinical testing brincidofovir had shown the potential for enhanced antiviral potency and a more favorable safety profile.

Chimerix (where one of us, Moch, was CEO), a 55 person North Carolina-based biopharmaceutical company, had previously made brincidofovir available to more than 430 critically ill patients in an expanded access program for the treatment of serious or life-threatening DNA viral infections, including adenovirus as well as herpes viruses (such as cytomegalovirus) and polyomaviruses.  This program started in 2009 as a series of individual physician-sponsored emergency INDs — investigational new drug exemptions issued in physician-certified compassionate use situations.

The program evolved via word of mouth to the extent that brincidofovir was made available under emergency INDs for more than 215 patients. During 2011, Chimerix received funding from Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to provide brincidofovir to an additional 215 critically ill patients for the purpose of gaining insights into the potential use of brincidofovir as a medical countermeasure against smallpox. (Department of Health and Human Services Contract No. HHSO100201100013C.  For further information on brincidofovir Study CMX001-350, see ClinicalTrials.gov Identifier NCT01143181.)

When BARDA funding ended in 2012, Chimerix stopped accepting new requests for compassionate use under its expanded access program. Although requests continued from physicians around the world, the company decided that it was in the best interests of the greatest number of patients to devote its limited human and financial resources to the clinical development pathway necessary for FDA approval of brincidofovir.

This post examines the implications of the ultimately successful campaign waged by Josh Hardy’s family to obtain access to brincidofovir for their son. We discuss several issues raised by the Hardy case, including the overarching question of whether it is fair for social media or influence of any form to play a role in determining which patients get access to experimental treatments; whether rescuing individual patients in need can be reconciled with an evidence-based regulatory approval process for new therapies; and whether there is a duty to “rescue” terminally ill patients by paying for access to experimental therapies.

Finally, we propose a new framework for regulating access to experimental treatments.

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