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Hobby Lobby, Conestoga Wood, The ACA, And The Corporate Person: A Historical Myth Bedevils The Law


April 18th, 2014
by Malcolm Harkins

On March 25, 2014, the Supreme Court of the United States heard arguments in two cases—Sebelius v. Hobby Lobby Stores, Inc. and Conestoga Wood Specialties v. Sebelius—challenging the validity of the Affordable Care Act’s (“ACA”) mandate that employer-sponsored health plans cover all FDA-approved contraceptives (the “Contraceptive Mandate”). In each case, closely held plaintiff corporations contend that the Contraceptive Mandate illegally infringed upon the corporations’ freedom to exercise religion.

The cases attracted attention because the Supreme Court had agreed to hear yet another challenge to the validity of the ACA’s provisions, but it has been less noticed that both cases, and others like them, implicate a fundamental question that the Supreme Court has never decided; on what basis, if any, is a corporation a “person” entitled to assert the constitutional and statutory rights of natural persons. Without denying the significance of the challenge to the ACA’s Contraceptive Mandate, the Supreme Court’s failure to define a principled corporate person theory has had—and continues to have—important and pervasive implications for the American legal system beyond the present cases.

Typically, legal concepts creating and regulating societal rights and obligations, like the corporate personhood concept, come into being incrementally in an extended evolutionary process. That evolutionary process is characterized by a dialectic give and take in which the principles justifying—or precluding—application of the concept in a variety of different factual scenarios are gradually clarified, defined and developed through a series of judicial decisions. The problem confronting the Supreme Court as it considers the Hobby Lobby and Conestoga Wood cases is that the concept of corporate personhood did not develop gradually or in an evolutionary process in which the meaning of the concept was developed and defined. Instead, the concept of the corporate person was imposed on the law ipse dixit, that is, by judicial fiat and without definition, in a series of late nineteenth century Supreme Court cases.

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Implementing Health Reform: The Latest Affordable Care Act Coverage Numbers


April 18th, 2014
by Timothy Jost

On February 17, 2014, the White House announced that 8 million Americans have signed up for private health insurance coverage through the health insurance marketplaces, or exchanges. This significantly exceeds the White House’s original goal of 7 million enrollees. It is far more than the Congressional Budget Office’s recent projections of 6 million.

The number of actual enrollees will be smaller than this number. The CBO’s projections are for the average number of those actually enrolled in coverage over the course of a calendar year. To calculate the average number of enrollees, one must subtract from the 8 million the number of individuals who fail to pay their premiums and thus are never actually enrolled in coverage, as well as those who will drop coverage at some later point during the year. To that reduced number, then, must be added back the number who become newly covered through special enrollment periods during the remainder of the year. In the end, 6 to 7 million average enrollees is probably a reasonable estimate.

This does not, however, exhaust the number of Americans who are now covered under the Affordable Care Act. The fact sheet states that 3 million young adults are covered under their parents’ plans because of the ACA. This number is probably high, but it is clear that the ACA has dramatically increased coverage of Americans between the age of 19 and 25 — the age group most likely to lack health insurance prior to the ACA (and still).

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The New Nutrition Facts Panel: Public Health Improvement Or Distraction?


March 19th, 2014
by Brian Elbel

Last month, the United States Food and Drug Administration announced long awaited proposed changes to the Nutrition Facts Panel (NFP), the nutrition information found on the back of packaged foods and beverages. The NFP is required to be on all packaged foods, with significant regulations on what is presented and how the information can be presented. Initially mandated in the first Bush Administration, the NFP offers a clear and consistent manner of presenting nutrition information—at least for those with the time and nutrition knowledge to benefit from the information.

The key questions behind the proposed changes are: will they be successful in altering consumer behavior, how might they be improved, and what overall role might they play in obesity prevention?

The NFP is clearly a source from which those already motivated and knowledgeable can easily access information and a base on which to build future approaches to addressing obesity. Put differently, this information will only work if people actively, directly choose to turn the package over, engage in information, and push past the many impulses pulling them towards the less healthy foods. The compelling nature of unhealthy foods means that individuals have to be particularly motivated, or the nutrition information has to be particularly compelling.

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Neighborhood Grocery Stores Combat Obesity, Improve Food Perceptions


March 12th, 2014
by Yael Lehmann

The Cummins et al article “New Neighborhood Grocery Store Increased Awareness of Food Access but Did Not Alter Dietary Habits or Obesity,” published in the February issue of Health Affairs, generated considerable media attention, with headlines claiming that grocery stores do not contribute to healthy diets or reductions in obesity.  However, the study offered no conclusive proof showing that access to grocery stores is not a part of the solution to preventing obesity.  In fact, the study showed clear signs of promise that the intervention was working in key aspects during the short time the researchers collected data.  Within just a few months after the new supermarket opened, for example, researchers documented significant improvement in residents’ perceptions about the choice and quality of fresh fruits and vegetables, along with improvements in their perception of healthy food accessibility.

The subject of the study, the Fresh Grocer in North Philadelphia, is a beautiful store with a bountiful fresh produce section. The supermarket, which is now thriving in one of the poorest neighborhoods in the country, was built from the ground up after a 15-year hiatus in which the surrounding community had no grocery store. Its opening has revitalized a historic African-American owned shopping plaza and reinvigorated the local neighborhood’s retail economy.

Has the store reduced the rate of obesity among local residents? This is a crucial question, but one that cannot be adequately deduced from the present study. All we know from this study’s findings is that obesity rates did not change significantly during the first six to nine months after the store’s opening – not surprising, given the many decades of gradual changes in eating habits that have led to the obesity epidemic.

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Howard Koh To Keynote Health Affairs Briefing Tomorrow On ACA And HIV/AIDS


March 10th, 2014
by Chris Fleming

One of the least explored yet most important parts of the Affordable Care Act (ACA) are provisions that hold promise for addressing serious health care challenges facing the 1.1 million Americans who are living with HIV/AIDS — and others like them — most of whom are impoverished and uninsured.

Please join Health Affairs Founding Editor John Iglehart on Tuesday, March 11, in Washington, DC, for a Health Affairs briefing on our March issue where we will spotlight topics related to the ACA and people with HIV/AIDS. The briefing will be keynoted by Howard K. Koh, Assistant Secretary for Health, U.S. Department of Health and Human Services.

WHEN:
Tuesday, March 11, 2014
9:00 a.m. – Noon

WHERE:
National Press Club
529 14th Street NW, Washington, DC, 13th Floor (Metro Center)

REGISTER ONLINE

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

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Financial Orphan Therapies Looking For Adoption


March 6th, 2014

There exist scientifically promising treatments not being tested further because of insufficient financial incentives. Many of these therapies involve off-label uses of drugs approved by the Food and Drug Administration that are readily available and often inexpensive. Pharmaceutical companies—largely responsible for clinical drug development—cannot justify investing in such clinical trials because they cannot recoup the costs of these studies.  However, without prospective data demonstrating efficacy, such treatments will never be adopted as standard of care.

In an era of increasing health care costs and the need for effective therapies in many diseases, it is essential that society finds ways to adopt these “financial orphans.” We propose several potential solutions for the non-profit sector, pharmaceutical companies, health insurers, patient driven research and others to accomplish this goal.

Drug Development Today

Under today’s drug development model, the vast majority of clinical trials are sponsored by pharmaceutical companies, and the process is lengthy, expensive, and, some have argued, inefficient. The cost of developing a new FDA approved drug is estimated to exceed $1.2 billion, the average time from lead to market is typically over 10 years, and only 1 in 10 drugs entering a phase I study is finally approved. Thus pharmaceutical companies, seeking to recoup this investment, conduct a return on investment (ROI) calculation with attention to both scientific and financial considerations such as the chances of success and whether the therapy will be sufficiently profitable to justify the high cost of clinical development.

These considerations sometimes lead to inefficient outcomes from society’s perspective in which promising and potentially transformative therapies are not pursued because of improperly designed financial incentives. We call such therapies “financial orphans.”

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A Call For A Deeper, Cross-Sector Examination Of The Hunger-Health Link


February 18th, 2014
by Sharon Feuer Gruber

Evidence continues to build that hunger should be approached in some measure as a public health issue, and Hilary Seligman of the University of California, San Francisco and co-authors contribute to this trove of research in the January Health Affairs journal article “Exhaustion of Food Budgets at Month’s End and Hospital Admissions for Hypoglycemia.” Hunger-relief organizations across the country can attest to the long-observed pattern of a rise in demand for food distribution at the end of the month. In fact, meal providers and food pantries tailor their decisions about purchasing, staffing, and program design around the uptick in client need as the month comes to a close. Seligman et al correlate this surge in demand with an increase in hospitalization among low-income individuals the fourth week of the month (a 27 percent increase in hospitalization among low-income individuals for hypoglycemia, according to their study). These findings suggest the profound need to devise food policies and programs with public health in mind.

However, to effectively address hunger as a public health issue in particular, hunger-relief organizations, community health organizations, universities, government, and others must take a collective impact approach. This cross-sector approach to complex, systemic social issues fosters coordination among such groups so they can have a greater positive impact than if they were to operate independent of one another; it is being turned to with increasing frequency to create large-scale social change. Policy can encourage a collective impact approach; it is already happening in the case of hospitals, which under Section 3025 of the Affordable Care Act, are penalized a portion of their Medicare reimbursement if they have a higher than expected rate of acute care readmissions within 30 days of discharge. (See 42 CFR part 412P.)

New community and regional partnerships are beginning to develop in part because of this incentive. The Atlanta Community Food Bank, for example, which distributed 21.8 percent more food and grocery items this past fiscal year than the last, is in early discussions with the Atlanta Regional Commission, the city health department, regional hospitals, and universities. Together they aim to confront the need for better health education and sustained access to nutritious food among low-income individuals discharged from hospitals for chronic, diet-related disease like diabetes, congestive heart failure, and associated complications. This is precisely the type of alliance that could help address the issues laid out in “Exhaustion of Food Budgets…” Policymakers need to build on this kind of ingenuity taking place in the field – especially if those in the field are expected to do more with less. That will certainly be the case, as the recently enacted Farm Bill imposes $8.6 billion in cuts to SNAP over the next 10 years, increasing demand on hunger-relief organizations even further.

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Health Affairs “Community Development And Health” November 2014 Theme Issue: Announcement


February 18th, 2014
by Chris Fleming

Health Affairs plans to publish an issue on the topic of “Community Development and Health” in November 2014. Details on the upcoming issue are available here. The deadline for submissions is June 1, 2014.

Papers will be competitively reviewed by editors, and, for those that are selected for external review, outside experts. We will make publication decisions based on these selection processes.

If you are interested in submitting a paper, please review our submissions procedures and guidelines. Contact senior deputy editor Sarah Dine (sdine@projecthope.org) or executive editor Don Metz (dmetz@projecthope.org) with any questions.

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Workplace Wellness Programs: Continuing The Discussion


January 27th, 2014
by Ron Goetzel

Editor’s note: One of the most-read Health Affairs articles last year was “Wellness Incentives In The Workplace: Cost Savings Through Cost Shifting To Unhealthy Workers,” by Jill R. Horwitz,.Brenna D. Kelly, and John E. DiNardo. The article engendered a Health Affairs Blog discussion between the authors and Ron Goetzel. (See here, here, here, and here.) Below is another installment of that discussion, from Ron Goetzel.

I have had several back and forth conversations with Professors DiNardo and Horwitz. I won’t bore the readers with a re-hash of old arguments. We don’t need to re-litigate the basic premises of our debate, from either point of view. Those interested in following that discussion can review our previous posts.

I would, however, like to respond to a central point made by DiNardo and Horwitz that employers should not interfere with the private lives of employees. I agree with this assertion to a certain point. It should be noted that many employers do “interfere” with employees’ private lives by not allowing them to smoke on premises, requiring them to wear seat belts when driving company vehicles, mandating that they wear protective gear (hard hats, work boots, gloves) at construction sites, and so forth.

Certainly, an employer cannot and should not tell workers what to eat or how much to exercise. However, an employer can provide guidance, education, skill building, and support programs to workers who wish to eat healthy foods and become more physically active. That, in my mind, is not interfering in workers’ lives but rather supporting their efforts at leading a healthy lifestyle.

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Implementing Health Reform: Filling In Details About The Shared Responsibility Requirement (Updated)


January 26th, 2014
by Timothy Jost

Although the Department of Health and Human Services has more or less finished its Affordable Care Act private insurance reform rulemaking agenda for the time being, the Internal Revenue Service still has important regulations outstanding. On January 23, 2014, the Internal Revenue Service proposed a set of less important regulations that further elaborate on the details of the shared responsibility or minimum essential coverage requirement, often called the individual mandate. These proposed rules will supplement and fill a few gaps in the final regulations published in August of 2013, described in an earlier Health Affairs Blog post.

The shared responsibility requirement obligates individuals who are not subject to an exemption to maintain minimum essential coverage (MEC) or pay a tax penalty. This requirement was upheld as a legitimate exercise of the power of Congress to tax in National Federation of Independent Business v. Sebelius.

MEC includes individual coverage, employer coverage, grandfathered coverage, and coverage under a number of government programs, such as Medicaid and Medicare. MEC, however, neither includes all forms of individual insurance coverage nor coverage under all government programs. Under previous rules, for example, MEC does not include Medicaid coverage that does not provide comprehensive medical coverage but rather only covers specific services such as family planning services, tuberculosis-related coverage, pregnancy-related services, or emergency medical care.

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Examination Of Health Information Technology’s Disappointing Impact Leads Health Affairs 2013 Top-Fifteen List


January 21st, 2014
by Chris Fleming

Years after promises of large gains from health information technology, evidence of the impact of health IT on efficiency and safety remain mixed, Arthur Kellermann and Spencer Jones report in the most-read Health Affairs article of 2013. Achieving health IT’s original promise will require standardized systems that are easier to use and more interoperable, and that provide patients with more control over their health information; providers must re-engineer care systems as well, Kellermann and Jones write. To celebrate the New Year, Health Affairs is making this piece and all the articles on the journal’s 2013 most-read list freely available to all readers for one week.

Second on the 2013 top-fifteen list is a report on 2011 health spending by analysts at the Centers for Medicare and Medicaid Services Office of the Actuary. Every year, Health Affairs publishes a retrospective analysis of National Health Expenditures by the CMS analysts, as well as their health spending projections for the coming decade. In the latest installment in this series, the analysts reported on 2012 health spending in our January 2014 issue and discussed their findings at a Washington DC briefing.

In the third most-read Health Affairs article of 2013, Linda Green and coauthors caution against projecting primary care physician shortages based on simple patient-physician ratios. They argue that increasingly popular strategies — such as the use of teams and nonphysicians, and better information technology and data-sharing — can potentially eliminate projected physician shortages.

The top fifteen articles for 2013 also include studies addressing the impact of states’ opting out of Medicaid expansion, the cost-shifting effects of some workplace wellness programs, and several other topics. The full list appears below. The list is based on online viewing statistics and covers all articles published in 2013.

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Review Of Accountable Care Organization Landscape Leads 2013 Health Affairs Blog Top Fifteen


January 17th, 2014
 
by Chris Fleming and Tracy Gnadinger

David Muhlestein’s comprehensive look at the growth of Accountable Care Organizations leads the list of most-read Health Affairs Blog posts for 2013. Muhlestein, Director of Research at Leavitt Partners, followed up this post later in the year with a discussion of why ACO growth was slowing.

Next on the top-fifteen list is a post by Tim Jost on exemptions from the Affordable Care Act’s individual mandate. Several posts in Jost’s extensive “Implementing Health Reform” series made the most-read list. Jost teaches law at Washington and Lee University and is a Health Affairs Contributing Editor.

Number three on our list is a post by Robert York, Kenneth Kaufman, and Mark Grube of Kaufman Hall on what declining inpatient utilization rates tell us about how health care is changing. At number four: an analysis of who will remain uninsured after the Affordable Care Act is implemented by Rachel Nardin, chief of neurology at Cambridge Health Alliance, and coauthors Leah Zallman, Danny McCormick, Steffie Woolhandler, and David Himmelstein,

The full list is below. (You can also review the 2013 most-read list for our sister publication, GrantWatch Blog.)

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Health Beyond Health Care: RWJF Commission Issues New Report


January 15th, 2014
 
by Chris Fleming and Tracy Gnadinger

Much of the political debate over health reform has focused on the important questions of affordable health insurance coverage and access to medical care. However, medical care is far from the most important factor influencing health, a fact that is at the core of a newly released report from the Robert Wood Johnson Foundation’s Commission to Build A Healthier America.

The Commission was initially formed in 2008 and issued 2009 recommendations concerning influences on health such as nutrition, physician activity, and tobacco use. The new report, “Time To Act: Investing in the Health of our Children and Communities,” also focuses on socioeconomic factors; specifically, it recommends increased investments in early childhood development, including universal access to quality early childhood development programs for low-income children under age 5; efforts to promote healthier neighborhoods through collaboration among the health, community development, and finance sectors; and a new orientation for health care providers toward nonmedical determinants of health and working with nonmedical professionals. The report provides examples of successful initiatives in each of these areas.

Most people think about health and health care together, said Mark McClellan of the Brookings Institution, who co-chaired the Commission with Brookings colleague Alice Rivlin, in a webcast marking the report’s release.  But “when you start looking at the evidence, looking at what’s working on the ground to actually have a meaningful impact on the health of people,” you realize that “you can’t get there just by putting more resources into health care.”

The new report signals a renewed emphasis for RWJF on addressing the broad universe of factors beyond health care that affect health. “Over the next year, our foundation is really going to invest in what we’re talking about as a culture of health — that is, how do we come together across sectors to make America healthier,” said Risa Lavizzo-Mourey, President and CEO of the foundation.. This post will briefly touch on the report’s recommendations, with more discussion to follow in the coming days via a guest post on Health Affairs Blog and our sister publication, GrantWatch Blog.

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Implementing Health Reform: The Risk Pool, Contraceptive Coverage Litigation, And Other Developments (Updated)


January 1st, 2014
by Timothy Jost

New Year’s Eve festivities did not interrupt the steady flow of Affordable Care Act developments. First, Marilyn Tavenner, Centers for Medicare and Medicaid Services Administrator, announced on December 31, 2013, that 2.1 million Americans were now signed up for private health plan coverage through federal and state exchanges under the Affordable Care Act and that an additional 3.9 million had signed up for Medicaid in October and November, bringing the total covered under the ACA to 6 million. Second, Supreme Court Justice Sonja Sotomayor on New Year’s Eve temporarily blocked the implementation of regulations that would require coverage of contraceptive items and services by a group of nuns and other organizations covered by the Christian Brothers Employees Benefit Trust, a church benefits plan.

What We Know, And Don’t Know, About The Pool So Far

It is important to understand what the 6 million number means. First, it does not mean that 6 million Americans who were previously uninsured will be newly insured on January 1. Many, probably most, of the 2.1 million private plan enrollees are individuals who were previously insured in the individual market or through the federal and state high-risk pools who will now be covered through the exchanges. One telling statistic from the October and November enrollment reports is that only half those determined eligible for coverage through the exchange were also determined eligible for premium tax credits. Clearly these are people who can afford insurance and were presumably already insured prior to 2014.

Many of the 2.1 million are no doubt individuals who had policies or plans in the individual or small group market that were not renewed for 2014, either because the plans or policies were not grandfathered and did not comply with 2014 market reform requirements or because they were grandfathered but the insurers that offered them unilaterally decided not to extend coverage. Much has been made by opponents of the ACA and by the media of millions of these Americans whose policies have been “cancelled” for 2014. Some of that coverage has suggested that these “cancellations” have left millions of Americans uninsured. In fact, as I have noted earlier, insurers cannot under pre-existing federal law simply “cancel” insurance coverage leaving an individual uninsured. Insurers must, unless they are leaving the market altogether, offer alternative coverage.

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The Contraceptive Mandate: Public Health Versus Religious Freedom


December 27th, 2013
 
by Marcia Boumil and Gregory Curfman

In addition to Marcia Boumil (photo and bio above), this post is co-authored by Gregory Curfman, the executive editor of the New England Journal of Medicine.

On November 26, the U.S. Supreme Court agreed to address the constitutionality of the “contraceptive mandate” imposed under the Patient Protection and the Affordable Care Act (ACA), the second major ACA-related challenge in the last two years. The ACA requires most employers with more than 50 employees to provide health insurance that covers preventive healthcare, including women’s preventive care, without co-pays or deductibles. Under the regulations implementing the ACA, this includes a broad range of medical applications, such as cervical cancer screening and emergency contraception. With numerous federal courts divided on the constitutionality of the contraceptive mandate, and requests from parties on all sides of the debate to intervene, it was inevitable that the Court would take up this issue.

In determining the scope of women’s preventive services to be included under the ACA’s mandate, the Department of Health and Human Services (DHHS) engaged the Institute of Medicine (IOM) to examine the unique preventive needs of women. The IOM is an independent, nonprofit organization engaged by the government to provide unbiased, authoritative advice concerning healthcare matters. The IOM Committee, comprised of twelve women and four men, reviewed the evidence-based preventive services that are important to women’s health and wellbeing, and then recommended which of these should be considered for coverage. The Committee recommended eight preventive services, including the full range of FDA-approved contraceptive methods.

Under the HHS implementing regulations, houses of worship are excluded from the requirement to provide contraceptive coverage. Religiously affiliated nonprofit organizations, such as colleges and hospitals, are not exempt but may avoid providing contraceptive coverage directly; instead, insurers are required to provide coverage directly to employees at no cost to employer or employee. From an actuarial perspective, contraceptive coverage is considered to be more cost-effective than spending for alternative health services and unintended pregnancies. Covered employers who fail to comply with the mandate are subject to substantial fines in the range of $100/employee per day. Several million employees are not included in the mandate, either due to their employers’ religious affiliation, the size of their employer, or grandfathering provisions.

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The Unintended Consequences Of The New Statin Guidelines


December 24th, 2013
by Amir Al-Kourainy

The American Heart Association (AHA), in collaboration with the American College of Cardiology (ACC), recently released new guidelines that urge a shift in how statins are prescribed. Until now, the drugs had primarily been used to treat high cholesterol; now, the guidelines say they should be used as preventive tools to lower an individual’s overall risk of heart attack and stroke. This change will pave the way for tens of millions of Americans who were previously not candidates for statin therapy to be placed on statins.

Advocates say this new approach will make a big difference in the fight against heart attack and stroke. But in practice such a major change may also have unintended consequences that threaten to move our society even further from prevention toward an increasing reliance on drugs.

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Provider Opportunities for Population Health Improvement


November 5th, 2013
by Anand Parekh

Significant changes in the health care sector have been set in motion or accelerated by the Affordable Care Act.  For health care providers, much of this activity has focused on improving patient care and lowering costs.  There are also numerous opportunities through the Affordable Care Act for health care providers to improve population health, either […]

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Workplace Wellness Programs: Continuing The Discussion With Ron Goetzel


October 30th, 2013
 
by John DiNardo and Jill Horwitz

We imagine that reading a point-by-point reply to Professor Ron Goetzel’s lengthy rebuttal to our previous reply, which responded to a previous lengthy rebuttal by Professor Goetzel to our original article, would try the patience of even the most dedicated readers of Health Affairs. Therefore, beyond reminding readers of the original article’s scope, here we use Professor Goetzel’s last response as a touchstone to summarize our difficulties with the arguments by advocates of workplace wellness programs based on financial incentives. We ask weary readers who do not wish to continue with this exchange, but are interested in workplace wellness, to look at the evidence we provide in our appendices, and make their own judgments.

First, we must remind Professor Goetzel that we wrote our original article to address the assumptions underlying workplace wellness programs based on substantial financial incentives — those encouraged by the Affordable Care Act — and not any of the other types of programs. That article did not comment on the myriad other public health interventions that might take place at the worksite, although some of our arguments could be applied to those programs as well. Unfortunately, many of Professor Goetzel’s comments are directed at claims we never made about those other programs, and we find his continued advocacy for those programs in the guise of a response to our work distracting.

Second, Professor Goetzel’s most recent posting helpfully outlines ACA wellness regulations that were released after we published our article. Like other commentators, he is right to highlight the new, expansive “reasonable alternative standard,” because it may mean that many more employees can access alternatives to the program standards. Once again, however, he is more optimistic than we and other researchers are that such protections will be easily accessed by employees. We are skeptical that it will be nothing more than a simple matter for an employee to exempt themselves from the general program. Among other things, the employee needs to know about the possibility of an alternative and to feel that asking for an alternative will not harm her, and her employer must be willing to comply.

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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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A National Initiative To Reduce Central Line-Associated Bloodstream Infections: A Model For Reducing Preventable Harm


September 23rd, 2013
by Peter Pronovost

Editor’s note: A full list of coauthors and their affiliated institutions appears at the end of this post.

The work to prevent central line-associated bloodstream infections in intensive care units is one of few national efforts to use empiric data to document a decrease in patient harm across the United States. A notable contributor was the On the CUSP: Stop BSI national initiative, which built upon the work at the Johns Hopkins Hospital and in the state of Michigan. This initiative spread to 1100 hospitals in 44 states, the District of Columbia, and Puerto Rico. The rate of an infection fell to 1 infection per 1000 line-days in the majority of hospitals, a rate deemed impossible just a few years ago.

In this post, we summarize the fractal infrastructure and overall results of the initiative, explore lessons, and offer policy recommendations for other national efforts to reduce preventable patient harm.

Background

Many efforts contributed to the national decline of central line-associated bloodstream infections (CLABSI) in intensive care units (ICU). (See here, here, here, here, here, and here.) Instrumental in these efforts were the Centers for Disease Control and Prevention’s (CDC) guidelines and infection control strategies, and hospital epidemiology and infection control. This impressive change offers an example of how the collaborative efforts of many, which were informed by evidence, research and valid measurement, can achieve widespread reduction in preventable harm.

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