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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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Washington Wakes Up To Socioeconomic Status


July 11th, 2014

John Mathewson, executive vice president of Health Care Services for Children with Special Needs (HSC) – a Medicaid managed care plan in D.C. for children on Supplemental Security Income (SSI) – recently spoke at the Association for Community Affiliated Plans (ACAP) CEO Summit before the July 4 Recess.

Mathewson described what he has dubbed The Kitten Paradox: When HSC examined environmental factors for children with asthma, it found that the presence of pets in the house was a common thread, not too far behind having a smoker around. Yet, it turns out the value a cat brings by protecting from mice or spawning a litter for sale outweighs any financial costs to the family associated with an ER visit, which are often free or carry a low copayment. Thus the paradox.

An awardee at the conference, Hennepin Health, catalogued the evidence showing that reliable housing can improve health outcomes, including improving mental health and lowering emergency room and inpatient hospital utilization.

The focus of these sessions was the social determinants of health, and a lot of these safety net health plan leaders’ heads were nodding throughout. The plans, which disproportionately serve Medicaid enrollees and thus ‘dual eligible’ seniors in Medicare, know something about the importance of social determinants that the health policy community – at least in Washington – is only now slowly waking up to.

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Interview: IOM President Harvey Fineberg Reflects On Lessons Learned


July 10th, 2014

On June 16, 2014, I spoke with Dr. Harvey V. Fineberg, as he wrapped up his second six-year term as president of the Institute of Medicine (IOM). We discussed how requests for work come to the IOM, the attributes of IOM reports that make them effective, and how the IOM maintains a strong voice in a crowded field.

Dr. Fineberg shared lessons learned from his analysis of events surrounding the Swine Flu immunization effort of 1976, and how, today, those lessons help him guide the IOM’s thinking about program assessment. We also discussed Dr. Fineberg’s work to bring together the various arms of the National Academies of Sciences to improve health.

You can listen to the full podcast at Health Affairs. These are a few of my favorite quotations taken from our discussion:

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New Drug And Device Approval: What Is Sufficient Evidence?


July 1st, 2014

Editor’s note: In addition to Jonathan Darrow, this post is also coauthored by Aaron Kesselheim. 

The federal Food, Drug, and Cosmetic Act gives the Food and Drug Administration (FDA) the authority to evaluate all prescription drugs and high-risk medical devices before they can be marketed to physicians and patients to ensure that they are safe and effective.

However, there is growing pressure to lessen the traditional standards for defining “safe and effective” for particularly promising therapies and accelerate patient access to these products.

A recent national health policy conference in Washington, D.C., explored the nature of the evidence needed for the regulatory approval of new therapeutics and the implications for patient care. The conference was organized by the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital/Harvard Medical School, the National Center for Health Research, and the American Academy for the Advancement of Science (AAAS).

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The Supreme Court And The Contraception Mandate: A Temporary Setback For Contraception Coverage


June 30th, 2014

Editor’s note: See Health Affairs Blog for more coverage of the Supreme Court’s Hobby Lobby decision.

Today, the United States Supreme Court ruled that for-profit companies may avoid providing contraception coverage to employees if the companies sincerely object on religious grounds. At its narrowest interpretation, this decision is a significant but remediable setback for women’s reproductive health. At its broadest (but least likely interpretation), the decision has the potential to wreak havoc on public health regulation.

The legal challenges to the Affordable Care Act’s (ACA’s) contraception mandate have been well described in three previous Health Affairs Blog posts. To briefly recap, though, the ACA requires preventive services to be covered without copayments or other cost sharing in most employer-supported health plans. To implement this requirement, the Department of Health and Human Services (HHS) issued regulations that include all FDA-approved contraceptives, and a company that does not provide no-cost coverage of contraception is subject to substantial penalties.

Three groups of employers are exempt from the mandate: small businesses with less than 50 employees, purely religious employers, and “grandfathered” plans that have not changed meaningfully since the ACA was passed. Additionally, religiously affiliated non-profits (such as universities and hospitals) received a special accommodation from HHS by which women can receive contraception from third-party insurers at no extra cost to employees or the organization if the organization objects to covering contraception and identifies an alternate insurer.

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The 2014 Culture of Health Prizes


June 25th, 2014

Today the Robert Wood Johnson Foundation awarded its 2014 Culture of Health Prize to six communities. These communities —  Brownsville, TexasBuncombe County, North CarolinaDurham County, North CarolinaSpokane County, WashingtonTaos Pueblo, New Mexico; and Williamson, West Virginia — were selected for the work they have done to place a high priority on health and bring partners together to drive local change.

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Correcting The Blind Spot In Accountability: The Role Of Pharmacy Care


June 25th, 2014

Editor’s note: In addition to William Shrank, this post is also coauthored by Andrew Sussman, Patrick Gilligan, and Troyen Brennan.

The Centers for Medicare and Medicaid Services (CMS) recently issued a Request for Information (RFI) to solicit suggestions about how to improve the Accountable Care Organization (ACO) programs. CMS stated that they seek recommendations about how the ACO program might evolve to “encourage greater care integration and financial accountability.”

The RFI explicitly stated that they seek information about how to better integrate Part D expenditures into ACO cost calculations to make pharmaceuticals part of the approach to care delivery and health care transformation.

The deadline for comments about encouraging Part D integration in ACOs has now passed. But the issue extends beyond ACOs. In addition, bundled payments and patient-centered medical home programs target hospitals and primary care providers to promote higher quality and lower cost care. All these programs have largely excluded prescription drug costs in their calculus, and offer no direct incentives for Part D plans to participate in and improve care.

Nonetheless, retail pharmacies and Part D plans have developed a number of strategies to participate. As CMS and policymakers reconsider ACO regulations to stimulate greater integration of prescription drug use in delivery system reform, we thought it important to offer a description of the marketplace response to payment reform activities at large.

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


June 19th, 2014

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

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

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

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The End Of The Blockbuster? Implications For Pricing Of New Drugs


June 16th, 2014

Editor’s note: In addition to Elias Dayoub, Anupam Jena and Darius Lakdawalla also coauthored this post. 

The productivity slowdown in drug innovation has been identified and widely discussed in recent years. In addition, the stagnation in the number of novel drugs (new molecular entities and new biologics) approved by the U.S. Food and Drug Administration (FDA) has also been well-documented.  Less well-appreciated, however, is the decline in the “applicability” of new drug approvals.  Each new drug treats fewer disease indications than drugs approved in earlier years.

Measuring the applicability of new drugs serves a dual purpose in helping better understand drug innovation. For one, assessing the number of indications for new drugs adds more nuance to assessments of growth or slowdown in the development pipeline. The relevant question is not necessarily how many new drugs are launched, but how many patients and diseases can be newly treated.  By accounting for the number of indications a new drug treats, one can better assess the number of patients the new therapy may benefit as well as the potential impact the drug approval will have on pharmaceutical spending.

The second important reason to measure pharmaceutical applicability is that it sheds light on how the costs of drug development translate into drug prices. If a drug has broad applicability to a larger number of indications, a drug developer can reasonably anticipate a greater number of patients will take the new medication. Conversely, if the drug treats only one indication, a developer expects fewer patients will use their drug.

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