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The Latest Health Wonk Review


October 24th, 2014

Louise Norris at Colorado Health Insurance Insider provides this week’s “falling leaves” edition of the Health Wonk Review. Jennifer’s insightful read includes a Health Affairs Blog post from J. Stephen Morrison on the U.S. Ebola response and the role of CDC head Thomas Friedan.

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Tax-Exempt Status For Nonprofit Hospitals Under The ACA: Where Are The Final Treasury/IRS Rules?


October 23rd, 2014

Months have now stretched into years, and there still remains no sign of final Treasury/IRS regulations interpreting the Affordable Care Act (ACA)’s provisions covering the expanded obligations of nonprofit hospitals that seek tax-exempt status under §501(c)(3) of the Internal Revenue Code.

The ACA amendments do not depend on formal agency policy to take effect. Nonetheless, Congress directed the Treasury Secretary to issue regulations and guidance necessary to carry out the reforms (26 U.S.C. §501(r)(7)). To this end, two important sets of proposed rules were issued: the first in June, 2012; and the second, in April 2013. While an informative IRS website lists various proposed rules and guidelines important to nonprofit hospitals, final rules seem to have performed a disappearing act.

Apparently recognizing the problems created by its delays, the agency has gone so far as to issue a special Notice letting nonprofit hospitals (and presumably the public) know that they can rely on its proposed rules. But this assurance overlooks the fact that the proposed rules themselves contained crucial areas in which final agency policy has not yet been adopted.

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Thomas Frieden And The U.S. Ebola Response


October 20th, 2014

On Friday, October 17, the White House named Ron Klain the new Ebola czar. This move followed a storm of criticism in the media, on Capitol Hill, and elsewhere. The criticism focused on the multiple mistakes made by the U.S. agencies and Texas Health Presbyterian Hospital in Dallas in the weeks since Thomas Eric Duncan, infected with Ebola, arrived in the United States on September 19. Duncan set off a disturbing train of events that included secondary infections of two nurses, Nina Pham and Amber Vinson, along with the lingering threat of additional infections.

That threat widened rapidly over the course of this past week. Dozens of health workers in Dallas remain under some form of quarantine or very close monitoring. Contact tracing revealed 300 persons who had possibly come in contact with Vinson during her Columbus Day weekend travel from Dallas to Cleveland and back. Schools were subsequently shuttered in Ohio and Texas.

Most remarkable, within a month the controversy surrounding the threat of Ebola to Americans had mushroomed into a political emergency for the Obama presidency itself, only a few tense weeks before the November 4 elections. Calls escalated for the appointment of an Ebola czar and a travel ban on persons originating in Liberia, Sierra Leone, and Guinea, the root sources of the Ebola emergency. A special measure of criticism was reserved for the Obama administration’s lead face in the U.S. response, Dr. Thomas Frieden, head of the U.S. Centers for Disease Control and Prevention (CDC). In the words of one observer, this week became full of “recriminations, political showboating… and panicked overreactions.”

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Brownsville: A Culture of Health, Not Health Challenges


October 14th, 2014

Editor’s Note: This post is part of an ongoing series written for Health Affairs Blog by local leaders from communities honored with the annual Robert Wood Johnson Foundation Culture of Health Prize. In 2014, six winning communities were selected by RWJF from more than 250 applicants and celebrated for placing a priority on health and creating powerful partnerships to drive change.

Brownsville is a culturally diverse, south Texas border town, a stone’s throw from Mexico. The 180,000 residents, mostly Spanish-speaking, live in one of the poorest metropolitan areas in the United States and have massive public health needs. In Brownsville, 48 percent of the children live in poverty, and 80 percent of our population is obese or overweight. Thirty percent have diabetes and half of them don’t know it. About 67 percent have no health insurance.

But in Brownsville, you will also find a robust, bike-friendly city, community gardens, and the world’s largest Zumba® class. That’s because in the last 10 years Brownsville has developed innovative partnerships, extensive outreach efforts, and a shared commitment to achieve wellness.

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Posts On ACA Tax Forms, Replacement Plan Lead September Health Affairs Blog Top-Ten List


October 10th, 2014

Tim Jost’s post on complicated Affordable Care Act (ACA) tax forms and his review of Avik Roy’s ACA replacement plan were the most-read Health Affairs Blog posts for September. These were followed by a CVS Health post from Troyen Brennan and coauthors on rethinking the sale of tobacco products in pharmacies and a post on bundled payments and innovation from Rebecca Paradis of the Network for Excellence in Health Innovation.

The full list is below.

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500 Days And Counting: Critical Steps In The Countdown To Achieving MDG 6


October 6th, 2014

Editor’s note: For more on global health, see the September issue of Health Affairs.

We are now less than 500 days away from December 31, 2015, the target date for reaching the world’s Millennium Development Goals (MDG). This includes MDG 6, the goal of combatting HIV/AIDS, malaria, and other diseases.

Astonishing progress has been made to date (as mentioned previously in our Health Affairs Blog post): AIDS-related deaths have fallen 35 percent since their peak in 2005; global mortality from tuberculosis has fallen by 45 percent since 1990; and global malaria mortality rates dropped 42 percent globally between 2000 and 2012. The key, of course, is maintaining this momentum in order to reach our goal.

It’s certainly no small task. But, three immediate steps can and must be taken:

  1. Enhance cost efficiencies;
  2. Build and strengthen partnerships; and
  3. Translate scientific developments into practice.
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An Interview With George Halvorson: The Kaiser Permanente Renaissance, And Health Reform’s Unfinished Business


September 30th, 2014

For decades, health policymakers considered Kaiser Permanente the lode star of delivery system reform.  Yet by the end of 1999, the nation’s oldest and largest group model HMO had experienced almost three years of significant operating losses, the first in the plan’s history. It was struggling to implement a functional electronic health record, and had a reputation for inconsistent customer service.  But most seriously, it faced deep divisions between management and the leadership of its powerful Permanente Federation, which represents Kaiser’s more than 17,000 physicians, over both strategic direction and operations of the plan.

Against this backdrop, Kaiser surprised the health plan community by announcing in March 2002 the selection of a non-physician, George Halvorson, as its new CEO.  Halvorson had spent most of his career in the Twin Cities, most recently as CEO of HealthPartners, a successful mixed model health plan.  Halvorson’s reputation was as a product innovator; he not only developed a prototype of the consumer-directed health plan in the mid-1990’s, but also population health improvement objectives for its membership, both firsts in the industry.

During his twelve year tenure as CEO, Halvorson not only guided the plan to solid profitability, but added a million members in California, its largest market, despite a devastating recession and a national retreat of commercial HMO membership.  He invested over $6 billion in computerized patient care systems and population health management infrastructure, healed the breach with Kaiser’s physicians, and markedly increased its consumer satisfaction scores, earning 5 STAR ratings under Medicare Advantage.  He left the organization at the end of 2013 with more than $53 billion in revenues and more than $19 billion in reserves and investments.

This interview covers Halvorson’s time at Kaiser, his views of health reform, including the unfinished reform agenda, and his public health activism.  It was conducted by Jeff Goldsmith, a veteran health industry analyst, and Associate Professor of Public Health Sciences at the University of Virginia.  Jeff is a member of the editorial board of Health Affairs.

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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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Pediatric Asthma: An Opportunity In Payment Reform And Public Health


September 18th, 2014

Editor’s note: The post is informed by a case study, the third in a series made possible through the Merkin Initiative on Physician Payment Reform and Clinical Leadership, a special project to develop clinician leadership in health care delivery and financing reform. The case study will be presented on Wednesday, September 24 using a “MEDTalk” format featuring live story-telling and knowledge-sharing from patients, providers, and policymakers. 

The Clinical Challenge: A Chronic, but Manageable Illness

Asthma affects 7 million children – more than 10 percent of kids in the U.S. – and is the most common chronic childhood disease. Yet even with high levels of insurance coverage, 46 percent of pediatric patients have uncontrolled asthma. There are substantial gaps in appropriate prescribing and adherence to effective medications. In addition, a multitude of non-medical issues influence a child’s ability to control their asthma: low parental health literacy, poor quality housing, and environmental triggers such as pests, mold, and cleaning chemicals. As a result 800,000 kids visit the emergency department (ED) for asthma each year.

In 2007 (the latest year which data are available) the U.S. spent over $56 billion on asthma care, of which nearly $27 billion was spent on pediatric asthma. Medicaid is the primary payer for pediatric asthma related hospitalizations with 55 percent of the market. Better control may also mean lower medical costs, due to reductions in ED visits, admissions, and other health care utilization – patients with poorly controlled severe asthma cost nearly $5,000 more per patient per year compared to average pediatric asthmatic costs.

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Taos Pueblo: A Sovereign Nation Sees Positive Public Health Results


September 15th, 2014

Editor’s note: This post is part of an ongoing series written for Health Affairs Blog by local leaders from communities honored with the annual Robert Wood Johnson Foundation Culture of Health Prize. In 2014, six winning communities were selected by RWJF from more than 250 applicants and celebrated for placing a priority on health and creating powerful partnerships to drive change. Interested communities are encouraged to apply for the 2015 RWJF Culture of Health Prize. Applications are due September 17, 2014.

The Taos Pueblo in New Mexico is a National Historic Landmark and one of a handful of places around the world designated a World Heritage Site by the United Nations. Native Americans have continuously lived in this ancient tribal community, with its remarkable multi-story adobe buildings, for more than 1,000 years. Today, the Taos Pueblo tribe has about 1,350 people living on some more than 100,000 acres, just outside the artist community of Taos.

The pueblo has its share of poverty and unemployment, along with troubling rates of diabetes, obesity, and alcoholism. Data from the Indian Health Service clinic at the pueblo show that about 47 percent of pueblo youth under age 20 are overweight or obese. And 21 percent of the adults have diabetes. Many pueblo residents live below the poverty level, which is not surprising as their economy is based on tourism, crafts, and a small casino.

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Same Care No Matter Where She Gives Birth: Addressing Variation In Obstetric Care Through Standardization


September 12th, 2014

In August, Health Affairs published a study highlighting an alarming fact in maternal health: The incidence of childbirth complications varies significantly from hospital to hospital across the United States. The study – led by Laurent Glance and colleagues at the University of Rochester – found that “women delivering vaginally at a low-performing hospital had twice the rate of any major complications than women delivering vaginally at a high-performing hospital.” The difference in these complication rates for cesareans was five-fold.

It is well known that variation in care contributes to higher rates of mortality and morbidity in all areas of health care, explaining the push toward checklists and other quality improvement tools and interdisciplinary collaboration. Identifying the primary reasons for variation in obstetric complication rates – why women giving birth in high-performing hospitals have lower complications rates – could be critical to understanding the reasons behind the increasing rates of maternal mortality and morbidity in the U.S. This study, along with other disturbing statistics, underscores the significant need for improvements in maternity care.

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Mortality Rate Increases With Emergency Department Closures


September 11th, 2014

The Health Affairs article, “California Emergency Department Closures Are Associated With Increased Inpatient Mortality At Nearby Hospitals,” by Charles Liu, Tanja Srebotnjak, and Renee Y. Hsia, recently published in the August issue, presents an important, timely, and well-conceived analysis, especially given the number of emergency department (ED) closures in the last 10-15 years, the concomitant rise in ED visits during the same period, and the likelihood of further closures due to increased hospital consolidation across the country since the study took place.

The article focuses on mortality rates and finds that hospitals in close proximity to an ED that had closed had 5 percent higher odds of inpatient mortality than admissions to hospitals not occurring near a closure, and that this effect disproportionately affected minority, Medicaid, and low-income patients, further exacerbating existing disparities in health care and health outcomes. This finding adds to Hsia’s body of work that calls attention to the disproportionate impact of institutional closures on health outcomes for vulnerable populations.

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Integrity In Retail Health Care: Rethinking The Sale Of Tobacco Products


September 3rd, 2014

Retail health care is a relatively new development in American health care.  It is true that much of the dispensing of medications has historically occurred through retail pharmacies, which sold a variety of other goods and services, but somehow that was not seen as the provision of health care.   Health care institutions, including doctors’ offices, hospitals and clinics, were the places that people went to be diagnosed and treated.  And those institutions did little other than health care; they did not, and still do not today, offer any products other than provision of care, including testing and treatment.  As such, these institutions demonstrated high integrity, defined as a state of being whole, and synonymous with cohesion and unity of purpose.

Now retail pharmacies, mass merchandisers and grocery stores are adding “health care” as another consumer good to be purchased on a mass scale.  Retail health care is in some cases, extending what the pharmacist does in the retail pharmacy: providing more advice about a variety of health care issues, giving vaccines, and working more closely with doctors’ offices.  In other cases, it is the opening of small clinic practices, often staffed by nurse practitioners, caring for minor ailments.  These kinds of clinics make great sense from the point of view of convenience and cost and have proven to be very popular, particularly given the shortage of convenient primary care that exists in many communities.

There are signs that the scope of retail health is deepening.  Pharmacies are planning to do more laboratory testing, in part to support a broader array of health advice from pharmacists, and in part to allow a wider set of complaints to be addressed in the retail pharmacies.  Walgreens has developed accountable care organizations with hospital partners.  At CVS Health, we have been very public about our effort to align with integrated delivery systems to help them manage population health by emphasizing joint efforts to improve medication adherence, support the management of complex patients, and create direct electronic medical record connectivity between our 900 retail clinics and the doctors’ offices.  Just last month, Walmart announced that their new clinics would be primary care offices, capable of caring for a range of chronic disease.

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Collaboration, Consistency, and Community Spirit: How Durham Advances Health


August 28th, 2014

Editor’s note: This post is part of an ongoing series written for Health Affairs Blog by local leaders from communities honored with the annual Robert Wood Johnson Foundation Culture of Health Prize. In 2014, six winning communities were selected by RWJF from more than 250 applicants and celebrated for placing a priority on health and creating powerful partnerships to drive change. Interested communities are encouraged to apply for the 2015 RWJF Culture of Health Prize. Applications are due September 17, 2014.

Durham, North Carolina is so richly endowed with health care resources that it is known as “the City of Medicine;” it is home to 95 percent of the companies that comprise the Research Triangle. Yet, while many of the county’s 288,133 residents are thriving, others are not nearly as healthy.

A 2004 community health assessment revealed that in Durham’s very diverse population — currently, 38.7 percent black, 42.1 percent white, and 13.5 percent Hispanic — there were high rates of cardiovascular disease and other chronic conditions, HIV and other sexually transmitted diseases, and infant mortality.

A 2007 evaluation also showed that 29 percent of the county’s adults were obese. The rate was 42 percent among African Americans. In the same report, 49 percent of adults said their health prevented them from participating in even moderate physical activities. Among children entering kindergarten in 2009, 18 percent were overweight or obese.

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Partnership And Progress On The Path To Achieving Millennium Development Goal 6


August 25th, 2014

Editor’s note: For more on global health, stay tuned for the upcoming September issue of Health Affairs.

In 2000, nearly 200 world leaders came together and agreed on a set of objectives intended to tackle some of the most pressing development challenges of our time, such as poverty, AIDS, and child mortality. With a target date of December 31, 2015, the Millennium Development Goals (MDGs) provided a clear path for progress and a platform for immediate action. Last week, on August 18, we reached a milestone on that path –- as of that date, 500 days remained to achieve these eight goals. So where do we stand, and what more must be done?

Combatting HIV/AIDS, Malaria, and Other Diseases

For those of us focused acutely on MDG number 6—combatting HIV/AIDS, malaria, and other diseases—the recent Millennium Development Goals Report had encouraging news. An estimated 3.3 million deaths from malaria were averted between 2000 and 2012 due to the expansion of malaria interventions, and efforts to fight tuberculosis have saved an estimated 22 million lives since 1995.

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Health Policy Brief: The Relative Contribution Of Multiple Determinants To Health Outcomes


August 22nd, 2014

A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) examines factors that can contribute to health status. In the United States, less than 9 percent of health expenditures go to disease prevention, and there is little support for social services, such as programs for older adults, housing, and employment programs.

This brief focuses on “multiple determinant” studies that seek to quantify the relative influence of some of these factors on health. It is part of a larger project, supported by the Robert Wood Johnson Foundation, which aims to create a structure for conducting analyses that demonstrate the value of investments in nonclinical primary prevention and their impact on health care costs.

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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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Spokane County: A Community Comes Together To Improve Health And Education For Every Child


August 18th, 2014

Editor’s Note: This post is part of an ongoing series written for Health Affairs Blog by local leaders from communities honored with the annual Robert Wood Johnson Foundation Culture of Health Prize. In 2014, six winning communities were selected by RWJF from more than 250 applicants and celebrated for placing a priority on health and creating powerful partnerships to drive change. Interested communities are encouraged to apply for the 2015 RWJF Culture of Health Prize. Applications are due September 17, 2014.

Spokane County is a metro area of more than 470,000 people, yet it’s still driven by the spirit of a small town. That sense of community is an essential part of the county’s ongoing work to improve the health of all residents by focusing on education.

In 2006, Spokane Public Schools’ high school graduation rate was less than 60 percent overall, while Spokane County’s rate was 72.9 percent. Spokane County educators were increasingly concerned about the future health and well-being of the county’s children, especially the 18 percent living in poverty.

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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework


July 31st, 2014

Editor’s note: In addition to Meaghan George, Sara Bencic and Darshak Sanghavi also coauthored this post. 

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer.

Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

A Call to Action: The Importance of Expanded Access Programs

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage.

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Recent Health Policy Brief: E-Cigarettes And Federal Regulation


July 11th, 2014

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) describes federal policy makers’ recent efforts to propose rules for e-cigarette regulation. E-cigarettes, virtually non-existent ten years ago, have skyrocketed in popularity, including among people who claim to use e-cigarettes as a tool to help them quit smoking altogether.

The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products such as cigarettes, tobacco in cigarettes, roll-your-own, and smokeless tobacco. But it left unregulated other tobacco products such as cigars, pipe and hookah tobacco, nicotine gels, and e-cigarettes.

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