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What Happens When A Retail Pharmacy Decides To Stop Selling Cigarettes?


February 26th, 2015

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

The sale of cigarettes and tobacco products at retailers with pharmacies has received considerable attention over the past year. The national debate reignited in February 2014, when CVS/pharmacy announced that we would quit the sale of cigarettes and tobacco products in our 7,800 pharmacies nationwide. In September 2014, we announced we were officially tobacco free — one month earlier than planned. This was met with kudos from the media, public health officials, and even the President of the United States.

But one question that did not receive anywhere near that level of attention was whether or not our actions would make a difference in the prevalence of smoking and, ultimately, in the public health.

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How Menu Labeling Could Spark Change Beyond The Menu Board


February 24th, 2015

If there’s one thing we’ve learned about catalyzing changes that prevent illness in the first place, it’s that passage of a single policy can be like lighting a match — illuminating the way towards strategies with greater impact and igniting the energy of leaders. The success of a menu labeling might be the match needed to inspire further policy change to shift the trend of increased diet-related chronic disease in the United States.

In November, the Food and Drug Administration released the final rule guiding calorie labeling of menu items at chain food service establishments with 20 or more outlets nationally. The rule will apply to fast-food and sit-down restaurants, supermarkets, convenience stores and movie theaters, and will take effect on December 1, 2015.

Once implemented, calorie counts will be posted for all items (including alcoholic drinks) on menus and menu-boards, and on display tags for salad bars, bakery items, and soda dispensers. A companion rule requiring calorie labeling for vending machines will take effect one year later.

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Indirect Effects From Menu Labeling Can Improve The Public’s Health


February 24th, 2015

Just this past November, the U.S. Food and Drug Administration (FDA) released sweeping final rules requiring that calorie information be posted on menus, menu boards, and vending machines. The regulations expand the proposed rule to include a wide variety of food outlets with more than 20 locations: quick service and table service restaurants, grocery stores and superstores, movie theaters, amusement parks, ice cream shops, takeout and delivery, vending machines, and even alcoholic beverages.

In the press release for the final rule, FDA Commissioner Margaret Hamburg stated, “making calorie information available on chain restaurant menus and vending machines is an important step for public health that will help consumers make informed choices for themselves and their families.”

Although the scientific evidence linking menu labeling to consumers’ purchasing behavior is weak, indirect effects may contribute more to incremental gains in public health. We highlight a few in the following blog post.

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Putting Humpty Dumpty Together Again: Consolidating Regulatory Authority Over Food Safety


February 23rd, 2015

The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.

Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.

This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.

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In Regulating E-Cigarettes, No Easy Fix For The FDA


February 20th, 2015

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

It is a victory that was made possible, in large measure, by a constellation of state and federal regulatory interventions: laws regulating the marketing and sale of cigarettes, barring sales to youth, banning indoor smoking, and taxing cigarette sales have all played a role in reducing rates of smoking.

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Vaccinating Against Iron-Deficiency Anemia: A New Technology For Maternal And Child Health


February 19th, 2015

When we think of killer diseases of global health importance, iron-deficiency anemia (IDA) is not something that immediately comes to mind. Yet the December 2014 publication of leading causes of death by the Global Burden of Disease Study 2013 reveals that IDA kills an estimated 183,400 people annually. To put this number in perspective, in the year 2013, IDA killed more people worldwide than ovarian cancer. In terms of years of life lost, IDA ranked higher than cervical cancer.

The fact that we compared IDA to two other well-known threats to the health of women is no accident. Because women of child-bearing age have low underlying iron reserves, they are at great risk of becoming deficient in iron and progressing to IDA. Pregnant women are especially vulnerable to IDA because of the high iron demands of the growing fetus. Growing children represent another important group who develop IDA.

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Oregon Bridges The Gap Between Health Care And Community-Based Health


February 12th, 2015

It is now commonly accepted that to achieve health, the U.S. health system must address the social determinants of health. While the integration of health care with social services and public health is happening relatively infrequently across the country, one bright spot can be found in Oregon, where an innovative Medicaid health system model, referred to as the coordinated care model, is showing early signs of success in bridging the gap between the community and the health care system.

Under Oregon Governor John Kitzhaber’s leadership, newly created coordinated care organizations (CCOs)—partnerships between physical, behavioral, and oral health providers—have over the past two years adopted Oregon’s coordinated care model, which was created as the foundation for Oregon’s health system reform efforts to ensure care is coordinated, performance is measured, positive outcomes are rewarded, and that there is a shared responsibility for health, sustainable rate of growth, and transparency in price and quality—all with the goal of promoting positive health outcomes.

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After The Worst In Liberia And Sierra Leone


February 9th, 2015

From January 19-27, we traveled to Liberia and Sierra Leone to engage with national leaders, health workers, citizens, non-governmental organization (NGO) implementers, international organizations, and United States, United Kingdom (UK), and other officials, including the African Union (AU), Chinese, and Cuban medical delegations. It was a moment of hope and nervous adjustment, as Ebola cases dropped suddenly and unexpectedly in Liberia, followed by reductions in Sierra Leone and Guinea.

We listened to the reflections of those who lived through and led the mobilization to roll back the unprecedented Ebola emergency, as it raged in the second half of 2014. We sought to understand the latest phase, as complicated efforts have begun to move beyond an emergency response and seek to achieve “zero” Ebola infections in 2015 — while safeguarding against new outbreaks. We discussed briefly early plans for long-term recovery. Across these different phases and concerns, we had a special interest in examining the US contribution.

The visit generated countless conversations with diverse experts who were remarkably gracious, insightful, and candid in their remarks. In this post we share select major impressions we carried home. These opinions are, of course, ours, and ours alone.

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How The Ebola Crisis Could Help Save 75,000 Patients


February 4th, 2015

It has taken an epidemic in West Africa to expose a troubling issue for U.S. hospitals and health policy: the short shrift given infection prevention.

In a thoughtful December Health Affairs Blog post, Dr. Leonard Mermel, an epidemiologist and infection control specialist, noted that over a three-month period his hospital’s work on Ebola preparedness “significantly strained our ability to manage other infection control challenges.”

That is a red flag for health care policymakers. As hospitals focus on Ebola preparations, we can’t lose sight of the fact that more than 700,000 Americans contract health care associated infections (HAIs) each year. About 75,000 people die from HAIs, such as Clostridium difficile (C. diff), Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococcus (VRE).

This is more than 10 times the number of patients who have died from Ebola across the globe.

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Beyond Wellness ROI Part II: The Case Study Of A Major Self-Funded Employer


January 30th, 2015

In a recent post, we agreed with Goetzel et al. about the advisability of moving away from a preoccupation with the return-on-investment (ROI) of wellness programs and toward the more systemic, iterative view required to make progress toward workplace “cultures of health.”

At the same time, we acknowledged Lewis et al. and others for helping to usher in a new and needed scrutiny of the fairness and effectiveness of employment-based wellness programs. But, we also cited peer-reviewed evidence that counters Lewis et al.’s conclusion that there are no conditions under which employer wellness programs, and by extension employer efforts to manage their core health-related value/sustainability challenge, can achieve a return-on-investment (ROI) ratio of better than 1-to-1 savings to cost.

Lewis et al. have added their voice to the scrutiny increasingly applied to employer use of outcome-triggered incentives or penalties to promote employee behavior change in the context of health-contingent programs under financial provisions in the Affordable Care Act. The momentum fueling these developments could soon extend far beyond wellness programs.

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Moving Beyond Wellness ROI Toward Employment-Based Cultures Of Health: Part I


January 26th, 2015

With their recent post declaring that employment-based wellness initiatives “increase rather than decrease employer spending on health care with no net health benefit,” Al Lewis and coauthors are continuing to exert a clarifying presence in a field with a history of unsubstantiated claims and suspect methods. This conclusion is not supported by the work with which we and others have been associated and is thus not one with which we agree.

Nevertheless, Lewis et al. are to be acknowledged for fueling the need for a sharper focus on the core challenge at hand for employers: how best to improve the value of their health care investment—that is, how to manage health care costs while improving employee health and productivity—in ways that are sustainable. Incremental, inconsistent and, at times, maddeningly slow progress has been made. Employment-based wellness has been at the forefront, even as the need for quality improvement continues.

Moreover leading employers with well-developed management and measurement approaches have moved well beyond calculating the return on investment of individual wellness efforts and are demonstrating the more comprehensive value of building “cultures of health.”

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Additional Requirements For Charitable Hospitals: Final Rules On Community Health Needs Assessments And Financial Assistance


January 23rd, 2015

On December 29, the Department of the Treasury and the Internal Revenue Service released long-awaited final regulations implementing Affordable Care Act provisions that impose additional obligations on charitable hospital organizations covered by §501(c)(3) of the Internal Revenue Code.  Published in the Federal Register on December 31 2014, the regulations are massive, consolidating a series of prior proposals into a single final body of regulatory law.  The regulations affect more than 80 percent of U.S. hospitals, both the 60 percent that operate as private nonprofit entities and the 23 percent that operate as governmental units.

Because state and local governments typically condition their own sales, property, and corporate income tax exemptions for nonprofit entities to a hospital’s §501(c)(3) status, the final regulations carry broad and deep implications from both a policy and financial perspective.  According to the Congressional Budget Office the 2002 the national value of the federal tax exemption exceeded $12 billion, a figure that undoubtedly has risen considerably.

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Moving From Mandate To Reality: A Roadmap For Patient And Family Engagement


January 20th, 2015

The 2010 Affordable Care Act (ACA) moved patient and family engagement to center stage in health care reform. The law mentions “patient-centered care” at least 40 times, with explicit references to patient engagement, patient experience, health literacy and shared decision making. Evidence is growing that meaningful patient and family engagement can help achieve the triple aim of better quality, better outcomes and lower health care costs and substantially reduce preventable harm.

Yet, despite these advances, the full promise of engagement remains mostly untapped, and much confusion remains about what constitutes meaningful patient and family engagement, and importantly, how to translate this evidence broadly into routine health care practice.

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CMS Spending Report Leads Health Affairs 2014 Top-Ten List


January 13th, 2015

A report on 2012 health spending by analysts at the Centers for Medicare and Medicaid Services Office of the Actuary was the most-read Health Affairs article in 2014. To celebrate the New Year, Health Affairs is making this piece and all the articles on the journal’s 2014 top-ten list freely available to all readers for two weeks.

Health Affairs publishes annual retrospective analyses 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 — which also made our 2014 top ten — the analysts reported on 2013 health spending and discussed their findings at a Washington DC briefing. The two reports documented continued slow growth in health spending; the 2013 report featured the slowest rate of health spending growth since CMS began tracking NHE in 1960.

Next on the 2014 Health Affairs most-read list was an article on PepsiCo’s workplace wellnesss program. John Caloyeras and coauthors at RAND and PepsiCo found that the diseases management component of the program saved money, but the lifestyle management component did not. This was followed by two Narrative Matters essays by Charlotte Yeh and Diane Meier; another Narrative Matters piece, by Janice Lynn Schuster, rounded out the list at number ten.

The full top-ten list is below. And check out the 2014 most-read Health Affairs Blog posts and GrantWatch Blog posts.

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Reconsidering Pauly And Coauthors’ ‘Economic Framework For Preventive Care Advice’


January 12th, 2015

In the November issue of Health Affairs, Mark Pauly and coauthors criticize the lack of cost-effectiveness considerations in the Affordable Care Act (ACA), which mandates that health plans include preventive care free at the point of use. The bodies critiqued, the Advisory Committee on Immunization Practices (ACIP) and the U.S. Preventive Services Task Force, convene health experts to develop recommendations for immunizations and other preventive services.

According to the authors, the task entrusted to these bodies by the ACA, of offering sound advice on preventive care without considering its cost-effectiveness, is “impossible to do well.” They propose instead an “economic framework” under which only services with “substantial external benefits” (e.g. a vaccination for contagious disease) would be mandated for coverage. We believe this position is misguided.

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Sovaldi, Harvoni Payment Issues Lead Health Affairs Blog November Most-Read List


December 24th, 2014

A piece by Laura Fegraus and Murray Ross on the challenges of paying for lifesaving but high-priced drugs like Sovaldi and Harvoni from was the most-read Health Affairs Blog post for November. This was followed by a critical analysis of workplace wellness programs from Al Lewis, Vik Khanna, and Shana Montrose.

Next came a post on the 2016 Notice of Benefit and Payment Parameters Proposed Rule from Tim Jost, and then a look at health care policy after the mid-term elections from James Capretta.

The full top-ten list for November is below.

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The Value of Workplace Health Promotion (Wellness) Programs


December 22nd, 2014

The recent Health Affairs Blog post by Al Lewis, Vik Khanna, and Shana Montrose titled, “Workplace Wellness Produces No Savings” has triggered much interest and media attention. It highlights the controversy surrounding the value of workplace health promotion programs that 22 authors addressed in an article published in the September 2014 issue of the Journal of Occupational and Environmental Medicine titled, “Do Workplace Health Promotion (Wellness) Programs Work?”  That article also inspired several follow-up discussions and media reports, including one published by New York Times columnists Frakt and Carroll who answered the above question with: “usually not.”

There are certainly many points of contention and areas for continued discussion on this topic. It turns out that Lewis et al. and I agree on many things, and there are other areas where we see things differently.

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Investing In The Health And Well-Being Of Young Adults


December 15th, 2014

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

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

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

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Does Public Health Have A Future?


December 10th, 2014

Ebola’s arrival in the U.S. hit Americans with a jolt. Regardless of how you feel about the response to date, it should remind everyone of the importance of public health.

Fortunately, public health in the U.S. has built an extraordinary track record of success. Smallpox, one of the most dreaded diseases in history, was eradicated worldwide. New vaccines have sharply cut the toll of deaths and disabilities from H flu meningitis, tetanus, pneumococcal sepsis and other deadly diseases.

Adding folate to foods dramatically reduced neural tube defects in newborns. Safer cars and better roadway designs cut fatal crashes per million vehicle miles traveled by 90 percent. Because smoking is far less popular than it once was, 8 million Americans have been spared early and agonizing deaths from cancer, heart disease, emphysema, and other smoking-related diseases.

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Workplace Wellness Produces No Savings


November 25th, 2014

During the last decade, workplace wellness programs have become commonplace in corporate America. The majority of US employers with 50 or more employees now offer the programs. A 2010 meta-analysis that was favorable to workplace wellness programs, published in Health Affairs, provided support for their uptake. This meta-analysis, plus a well-publicized “success” story from Safeway, coalesced into the so-called Safeway Amendment in the Affordable Care Act (ACA). That provision allows employers to tie a substantial and increasing share of employee insurance premiums to health status/behaviors, and subsidizes such program implementation by smaller employers. The assumption was that improved employee health would reduce the employer burden of health care costs.

Subsequently, however, Safeway’s story has been discredited. And the lead author of the 2010 meta-analysis, Harvard School of Public Health Professor Katherine Baicker, has cautioned on several occasions that more research is needed to draw any definitive conclusions. Now, more than four years into the ACA, we conclude that these programs increase, rather than decrease employer spending on health care with no net health benefit. The programs also cause overutilization of screening and check-ups in generally healthy working age adult populations, put undue stress on employees, and incentivize unhealthy forms of weight-loss.

Through a review of the research literature and primary sources, we have found that wellness programs produce a return-on-investment (ROI) of less than 1-to-1 savings to cost. This blog post will consider the results of two compelling study designs — population-based wellness-sensitive medical event analysis, and randomized controlled trials (RCTs). Then it will look at the popular, although weaker, participant vs. non-participant study design. (It is beyond the scope of this posting to question non-peer-reviewed vendor savings claims that do not use any recognized study design, though those claims are commonplace.)

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