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HHPR 2012 Fall Issue; Volume 13, Issue 2

Assessing the Affordable Care Act

Harvard Health Policy Review

HARVARD HEALTH POLICY REVIEW FOUNDED IN 1999 / VOL. 13, SPRING ISSUE WWW.HCS.HARVARD.EDU/~HHPR

Editor’s Note 2 Pragya Kakani FEATURES Health Policy After the Election 3 Zirui Song, PhD What Should Be Next for Health Reform? 6 Sally Pipes Regulatory Burdens of the 9 Laxmaiah Manchikanti, MD, Affordable Care Act Joshua Hirsch, MD Assessing the Health Care Decision 13 Ilya Somin, MA, JD Walmartizing Preventive Healthcare Services: 16 Sanjay Saini, MD, a novel approach for lowering costs while McKinley Glover, MD improving access, quality, and utilization costs HEALTH HIGHLIGHTS The Imperative and Opportunity 18 Elizabeth Teisberg, PhD, M. Eng., of Chronic Disease Scott Wallace, JD, MBA The Free Clinic: Charity Care in the 21st Century 20 Frederick Barken, MD Breast Density Notification Laws 22 Handel Reynolds, MD and the Patient’s Right to Know Food Democracy on the March 24 Mark Winne, MA Cost Savings in the Emergency Department: 26 Peter B. Smulowitz, MD, MPH, Look Beyond the Low Acuity Visits Bruce Landon, MD, MBA Eating Disorders on College Campuses: 28 Megan Jones, PsyD, Alison Darcy, Implications for Prevention and Treatment PhD, Danielle Colborn, PhD, Maria Christina Stewart, PhD, & Kara Fitzpatrick, PhD STUDENT CONTRIBUTIONS Fixing Medicaid: Going Beyond the PPACA 33 Samita Mohanasundaram, AB Candidate Covered, California: Branding the 35 Erynne Jones, MA Candidate California Health Benefit Exchange Effects of the Affordable Care Act on Safety-Net Providers: 37 Partow Zomorrodian, Intangible Obstacles for Health Care Access MA Candidate Eliminating Tax Exemptions on 39 Emily Shearer, AB Candidate Employer-Sponsored Health Insurance Valuing Patient Satisfaction: A New Paradigm in 40 Thomas Hwang, AB Candidate Medicare Hospital Reimbursement Policy

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editor’ s note

Editor’s Note With the Supreme Court recently upholding the Affordable Care Act (ACA) as constitutional and the reelection of President Barack Obama, it seems the ACA is here to stay. By most accounts, this colossal work of legislation – amounting to over 2500 pages – will represent the most significant attempt at health reform in the United States since the creation of Medicare and Medicaid in 1965. Many aspects of the bill are also beginning to be put into practice including but not limited to the development of accountable care organizations (ACOs) and health insurance exchanges as well as the expansion of Medicaid. For these reasons, we at HHPR have dedicated our Fall 2012 issue to investigating the ACA.

Editor-in-Chief Pragya Kakani Managing Editor Marissa Suchyta Business Manager Bradford McGann Publisher Linda Zhang Design Chair Esther Lim Senior Editors Allan Hsiao, features James Sun, features Sifon Ndon, student contributions Brandon Jones, health highlights Young Kwon, online content Associate Editors Sarib Hussain Nikhil Mehandru Claire Motyl Arifeen Rahman Katie Rainer Edward Maile The Harvard Health Policy Review is an undergraduate publication of Harvard College. The Harvard name and Veritas Shield are trademarks of the President and Fellows of Harvard University.

Inside this issue you will find articles focusing on a diverse spectrum of issues related to the ACA by experts in the field as well as graduate and undergraduate students. By Zirui Song, PhD, Harvard Medical School and Sally Pipes, President of Pacific Research Institute you will find opposing views on the state of health reform after the 2012 Election. Following these more broad overviews, there is also a discussion of more specific issues including constitutional and regulatory concerns surrounding the ACA, preventive care access, Medicaid expansion, Medicare reform, exchange establishment, and more. It is our most sincere hope that these articles will provide our readers with a thorough overview of the variety of political and policy questions raised by the ACA. Given the controversial nature of the bill in the public discourse, we are proud that our pieces reflect a diverse range of opinions and perspectives. In addition to our pieces analyzing aspects of the ACA, we also have several pieces in our “Health Highlights” section examining other topics relevant to health policy discourse today. This includes pieces on the role of charity care in the American health system, increasing access to food through local organization, and assessing how to reduce cost in the emergency room. These topics are especially relevant as they tackle concerns related to health care access for low-income Americans who, as a population, often have worse health outcomes and less access to care. In the “Health Highlights” section you will also find a discussion on how to better coordinate care for those with chronic conditions and those with eating disorders as well as how to increase the efficacy of breast cancer screening. For their unwavering commitment and efforts in developing this issue, we’d like to thank our dedicated staff including our senior and associate editors, design chair, business manager, publisher, and managing editor. We would also like to thank our advisers Warner Slack, MD, David Cutler, PhD, Mary-Jo Good DelVechhio, PhD, Haiden Huskamp, PhD, and Peter Grant, JD for making themselves available to guide us through the publication process. Finally we would encourage our readers to check our website at www.hhpronline.org for more information about the publication, subscription information, updates about upcoming events. To supplement our print publication, we would also encourage readers to read our new online blog called HHPRTalk, which is accessible from our homepage. The blog will regularly feature high quality pieces from Harvard undergraduates on a broad range of topics including medical sociology, bioethics, drug development, health economics, and more. As always, any questions or comments from our readers are warmly welcomed and can be addressed to hhpr.harvard@gmail.com We hope you enjoy this latest issue of HHPR, and thank-you for your readership. Sincerely, Pragya Kakani Editor-in-Chief Fall 2012

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Harvard University Student Organization Center at Hilles, Box #40 59 Shepard Street Cambridge, Massachusetts 02138 ©2012 by President and Fellows of Harvard University. All rights reserved. No part of this publication may be reproduced in any form without express written consent from the publisher.

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about the cover Cover picture: The cover photo is President Barack Obama’s signature on the Patient Protection and Affordable Care Act on March 23, 2010. The photo does not in any way represent endorsement by President, First Family, or White House of the Harvard Health Policy Review. (Official White House Photo by Chuck Kennedy)

FEATURES Health Policy After the Election >>> Zirui Song, PhD

ealth policy took center stage in the 2012 election. Months of debate over the expansion of health insurance, the future of Medicare, and the role of government in health care placed the Affordable Care Act (ACA) squarely in the fore. President Obama’s reform law, built on a vision of federal leadership, sought to cover 30 million uninsured through expansions in Medicaid, maintain traditional Medicare for 50 million seniors, protect individuals with preexisting conditions, and move the delivery system towards lower spending and higher quality through accountable care organizations. In contrast, Governor Romney promised to repeal the law, favoring the philosophy of a more market-based health care system based on individual choice and market competition to reduce federal health spending. The Republican ticket proposed fixed subsidies to individuals to purchase insurance, block grants to states for their Medicaid programs, and vouchers to seniors to purchase a private Medicare plan. As the policy debate focused on their contrasts, often ignored were discussions of the common goals shared by both parties: expanding coverage, slowing the growth of health care spending, and improving the value of health care. Lost was the reality that government policies require functioning markets, just as market competition requires referees. More importantly, lost was the nuance that

health care is perhaps the most complex sector of our economy, where fiscal realities meet individual values, where the building blocks of a policy’s monetary impact can be out-shadowed by its impacts on individual patients’ lives, and where regulation is fit for some areas but markets for others. President Obama’s reelection gives the ACA a chance to fulfill its promise in bringing the health care system closer to those common goals. To many, the election will be remembered as a victory for the decidedly Democratic vision. Yet despite this view, victory for the ACA might be more appropriately remembered as an opportunity to achieve a shared vision—for the major tenets of the ACA prominently feature efforts to blend regulation with markets, mandates with choices, and Democratic ideas with Republican ones. As policymakers turn towards its implementation, one hopes that common ground may come to light in at least three major areas: expanding coverage, slowing spending, and improving quality.

Expanding Insurance Coverage While the individual mandate was broadly viewed as the central component of the health care reform law, generating some of the most divisive debate, its success was always contingent upon the creation (and operation) of federal and state-based

health insurance markets. Commonly known as insurance exchanges, these online marketplaces are designed to help individuals and small businesses navigate the complex insurance mark to purchase a coverage option that is both affordable and appropriate. Private plans compete for enrollees on the basis of premiums and benefits in a regulated marketplace where plans must satisfy basic requirements for entry, such as having a minimum benefit package. Consumers exercise individual choice in selecting among plans with the help of search tools and organized information. They may also obtain lower premiums through better risk pooling. On January 1, 2014, exchanges are due to become fully operational in every state. States have the option to establish their own exchange, join a state-federal partnership exchange, or join a federally-facilitated exchange. To date, 18 states and the District of Columbia have established fully statebased exchanges, with most appointing a governing board to work with insurers and a staff to operate it. Five states have chosen a joint federal-state partnership exchange, where the state assumes a portion of responsibilities for operating the exchange and the federal government does the rest. Another 18 states have elected to default into a federal exchange. The 10 remaining states remain undecided.1 Insurance exchanges allow policymakers to blend the individual mandate with a market system in order to expand coverage. Building an exchange is difficult, requiring investment costs and cooperation between state governments and private insurers. Contracts and subcontracts will need to be negotiated. Regulations will need to be carefully crafted to ensure fair competition between plans. Yet

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at the same time, market opportunities and flexibility will be needed to entice insurers to participate. Finally, the online marketplace will need to be user-friendly, allowing consumers to easily navigate and compare their options. One model of a state-based exchange is in Massachusetts, where the Commonwealth Care exchange was created after legislation was passed to expand coverage in 2006. This exchange has enrolled about 200,000 low-income residents with substantial subsidies to aid in their enrollment. States that can heavily subsidize their own exchange may find this model appealing. On the other hand, states that have fewer resources to support a fullyfunctioning exchange or fewer residents to fill its own risk pool may opt for one of the other options. In either case, building a well-functioning exchange will be a critically important task for policymakers. Slowing Medicare Spending Federal health care spending is the predominant driver of the nation’s long-term debt. In particular, the growth of Medicare spending threatens the nation’s economic recovery amidst an aging population.

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The Romney-Ryan ticket proposed to cut Medicare spending by turning Medicare into a premium support program, in which seniors would receive vouchers to purchase a private Medicare plan of their choice. Created and marketed by private insurers, these Medicare plans would compete against the government’s traditional Medicare program and each other for beneficiaries. In every county, the government’s share of spending for Medicare beneficiaries would be determined by a bidding system where plans submit the amount they are willing to receive to insure a beneficiary. The government would pay no more than the second-lowest bid. The plan that bid lowest may reward enrollees with extra benefits, whereas higherbidding plans would have to charge beneficiaries an additional premium. Thus, the system would encourage seniors to enroll in the least expensive plans. The ACA takes a different approach. Rather than altering the fundamental structure of Medicare, which could expose seniors to higher premiums, it begins to change how Medicare pays physicians and hospitals. The ACA transitions provider organizations away from the fee-for-service system that exclusively rewards volume and intensity to bundled or global payment systems that reward quality and value. Accountable Care Organiza-

tions—groups of doctors and hospitals that take joint accountability for spending and quality for a population of Medicare beneficiaries—enter into multi-year contracts with Medicare in which they are given a spending target and rewarded for spending below that target. Moreover, they are incentivized to improve quality of care in areas such as cancer screening, care coordination, and patient experience. On January 1, 2012, 59 Accountable Care Organizations entered into new contracts with Medicare. Some did so via the Shared Savings Program, in which spending over the target is not necessarily penalized. Others, including provider organizations affiliated with Harvard Medical School, entered through the Pioneer Program, which imposes financial penalties for exceeding the target in exchange for larger rewards for achieving savings. In July, 89 additional provider organizations entered through the Shared Savings Program, bringing over 130,000 physicians and 2.2 million beneficiaries into the accountable care paradigm.2 While payment reform is certainly different from privatizing Medicare, it shares a basic characteristic with the Republican approach. In a less stringent way, changing the reimbursement system for physicians and hospitals towards bundled and

FEATURES global payments also moves the government’s share of Medicare spending towards a budget. Instead of giving the budget to private insurers, the ACA gives it to provider organizations, allowing them to decide how to reduce low-value spending and where to invest in quality. As incentives become more closely aligned in the accountable care framework, decisions made by patients and their physicians will determine the performance of their provider organization with respect to the budget. Physicians and patients, on the same team, will face similar incentives to improve the value of care. Improving Health Care Delivery Policymakers from both parties believe that the delivery of health care should be more efficient and of higher value. Accountable Care Organizations in Medicare are the initial vehicles for improving the delivery system. Yet even before the passage of the Affordable Care Act in 2010, provider organizations across the country had begun working with private insurers on similar contracts that focused on improving the value of care (more benefit per dollar spent). In a number of major health care markets, such organizations are now accepting bundled payments across multiple insurers, creating an opportunity to improve care on a broader scale. Many of them also include teaching hospitals, bringing the next generation of physicians closer to the changing landscape of health care. Over the past decade, an abundance of evidence has shown that more expensive care is not necessarily higher quality care. In fact, health care markets in the U.S. that spend more often have lower quality of care and worse health outcomes on certain measures. As health care reform moves towards its next chapter—creating value rather than volume—national politics may no longer become the primary venue of debate. Rather, a different debate will take place within meeting rooms and department seminars of the nation’s major provider organizations. It will be a debate about how to practice medicine in an increasingly constrained world, no matter which party is in office. Provider organizations will need to figure out how to take a global budget for the care of a population and divide it among multiple specialties and departments that previously generated their own revenue through volume. They will need to reconfigure health care from its currently fragmented foundation to a more cohesive whole. The cost and delivery of care will need to be negotiated from within—requiring a new type of cooperation among providers who learned to practice medicine in a system that has long rewarded silos. In this upcoming chapter of health care reform, physicians rather than policymakers will be asked to take the lead. Physician leadership will be

crucial for building a culture of medicine in which providers feel united in a common mission to improve the value of care, as pressures to slow spending continues to mount for the federal budget. Thus, when one physician avoids an unnecessary procedure, organizations will need to ensure that all physicians benefit from the savings. When one patient reports high satisfaction with care, organizations will need to reward all providers who contributed to that patient’s care. Innovations within the organization to encourage teamwork and care coordination will be critical, no matter the politics of the nation. Transforming the culture of medical care in a new budgeted health care economy may take years to build. As with expanding coverage and reforming payment, there will inevitably be growing pains and potential pitfalls. Yet the imperative for doing so will only become stronger, as health care begins to embrace millions of newly insured patients and as health care spending increasingly determines how much the nation can afford to spend on other programs.

***

Health policy is ultimately about the patients whom medicine cares for and the populations that public health protects. Yet to touch those for whom it is intended, health policy needs to first traverse a complex political system. Since the inception of Medicare in the 1960s, national politics have often shaped its direction. Differences between the two major parties have extended from philosophical contrasts over the role of government to strategic contrasts over how to achieve the well-recognized goals surrounding coverage, spending, and the value of medical care. These differences are important. Debate is needed. Yet it would be undesirable, for those who debate and more importantly those whom the debate is for, if gridlock in the political system prevents progress towards those goals. References 1. Kaiser Family Foundation. State Decisions for Creating Health Insurance Exchanges in 2014, as of December 4, 2012. http://statehealthfacts. kff.org/comparemaptable.jsp?ind=962&cat=17 2. HHS announces 89 new accountable care organizations [news release]. US Dept of Health and Human Services. July 9, 2012. http://www.hhs. gov/news/press/2012pres/07/20120709a.html.

Zirui Song is a third year medical student at Harvard Medical School and a graduate of the Ph.D. Program in Health Policy at Harvard University.

Fall 2012 Volume 13, Number 2

FEATURES What Should Be Next for Health Reform? >>> Sally C. Pipes

t’s often said that elections have consequences. One of the most significant consequences of President Barack Obama’s victory on November 6 is that the Affordable Care Act is not going away. In spite of that reality, Obamacare remains the wrong prescription for America’s healthcare ills. The president’s reform package will drive health costs higher -- and force individuals and government alike to pay ever more for care. American families and taxpayers simply cannot afford to shoulder the cost burden that the Affordable Care Act will place on them. With outright repeal of the law a political impossibility--atleast,forthenextfouryears--reformers will have to address Obamacare’s flaws incrementally. So what’s next? Congress can take on several components of the law immediately. Based on how they’ll impact American health care, each may even attract bipartisan support from one-time supporters of the Affordable Care Act. The judiciary still has a role to play in health reform, too. Although the Supreme Court ruled by a five to four margin in June to uphold the Affordable Care Act’s individual mandate by christening it a tax -- and thus under Congress’s constitutionally enumerated powers -- various other legal questions remain In 2013, the courts could hand down verdicts on several significant portions of Obamacare -- including the constitutionality of the mandate that employers offer coverage, whether subsidies may be distributed through federally operated insurance exchanges, and whether Congress can mandate the coverage of contraception despite religious objections. ***

Let’s take a look at what Congress can do. First, there are the law’s community rating rules, which limit the degree to which insurance companies can adjust premiums based on age, family composition, tobacco usage, and geography. Most notably, the law prohibits insurers from charging older patients more than three times what they charge younger patients. The problem with such a ratio is that older Americans spend far more on healthcare than younger Americans. Americans aged 45-64 years spent, on average, $5,511 on healthcare in 2009, according to the Kaiser Family Foundation. For Americans ages 18 to 24, that number was only $1,834. For 25 to 44-year-olds, it was $2,739.1 Enforcing a community rating ratio of three to one, therefore, would necessitate shift-

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ing a significant portion of healthcare costs from older Americans to younger Americans. Young adults are generally less wealthy than middle-aged Americans -- and so are less able to withstand increases in the cost of insurance. If premiums grow enough, young adults may forego health insurance altogether -- regardless of Obamacare’s individual mandate, which requires that they obtain health coverage. The law’s maximum individual penalty for going without insurance will be just $95, or 1 percent of income, starting in 2014 and will rise to $695, or 2.5 percent of income, in 2016. The community rating rules effectively guarantee that the penalty for remaining uninsured will be less than the cost of insurance for many young people. Of course, Democrats will not sign off on a complete repeal of community rating. But once they see a large portion of young adults -- many of whom voted for President Obama -- complaining about the skyrocketing cost of insurance, they may be inclined to consider tweaking the formula. By changing the community-rating ratio to five to one, for instance, Congress could offer significant relief to young Americans’ wallets -- and thereby encourage them to purchase coverage. According to a 2009 actuarial analysis by the management consulting firm Oliver Wyman, shifting from a 5:1 ratio to a 3:1 ratio would result in a premium hike of about 35 percent for the youngest third of the population. Such a shift in the rating environment, the report notes, would also “cause an additional 500,000 younger, healthier members to exit the market.”2 It’s reasonable to assume, then, that raising the community-rating ratio would cause many young Americans to enter the insurance marketplace -- and lower the uninsured rate. Second,Congressmustreducefederalsubsidies for people who purchase coverage in the state-based insurance exchanges envisioned by Obamacare. At present, those making up to four times the federal poverty line will qualify on a sliding scale for federal assistance in 2014. So, a family of four earning up to $92,200 a year would qualify for subsidies.3 The Congressional Budget Office recently revised its estimate of the cost of the subsidy program -- to $574 billion over the next seven years.4 With the cost of insurance headed ever higher, that number will no doubt go up. In today’s era of trillion-dollar budget deficits, taxpayers can’t afford to be that generous. Congress must instead reserve subsidies for the truly needy. Third, Congress must similarly rein

in Obamacare’s expansion of Medicaid. The Affordable Care Act calls on states to offer Medicaid to anyone making less than 133 percent of the poverty line -- or just over $30,000 for a family of four.5 The federal government has promised to cover the full cost of the expansion for the first three years and a share that declines on a yearly basis after that, until the federal responsibility reaches 90 percent in 2020. The Supreme Court permitted states to opt out of the law’s expansion of Medicaid by a seven to two margin in June. As a result, the Congressional Budget Office now estimates that Medicaid will cover an additional 12 million people -- six million less than originally projected, before the Supreme Court decision.6 Even with the federal assistance Obamacare promises, the cost to states of expanding Medicaid will be crippling. For one, the states must shoulder the immense administrative costs involved in expanding the healthcare entitlement. According to Edmund Haislmaier and Brian Blase of the Heritage Foundation, that tab could reach nearly $12 billion for the states between 2014 and 2020.7 Further, the federal handouts will only cover individuals who are newly eligible for Medicaid under Obamacare. The states would have to cover the entire cost of coverage for those who were eligible for Medicaid before healthcare reform but neglected to enroll -- an estimated 14 million people. That could saddle states with billions of dollars in new health expenses -- before taking into account any increase in enrollment due to the federally driven expansion of the program. These new potential costs have forced many state executives to opt out of the Medicaid expansion. Texas Gov. Rick Perry, for instance, will not expand the Lone Star State’s Medicaid program in accordance with Obamacare’s wishes, as his state would face roughly $27 billion in new costs through 2023.2 Congress must give states more leeway through block grants to manage their Medicaid programs as they see fit. If the federal government doesn’t, then they may have to bail the states out down the line, when Medicaid -- already the largest expense in many states -- sinks their budgets entirely. Fourth, Congress should vote to repeal the Affordable Care Act’s counterproductive tax on medical devices. Like so many other provisions within Obamacare, the 2.3-percent levy on medical devices, which went into effect on January 1, 2013, will raise the cost of health care. According to Richard S. Foster, the chief actuary at the Centers for Medicare and Medicaid Services, the device tax “would generally be passed through to health con sumers in the form of higher drug and device prices and higher insurance premiums.”9

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The tax will also undermine American innovation. The billions that the federal Treasury squeezes each year from medical-device companies are billions that can’t be spent researching potentially groundbreaking new treatments or therapies. Already it takes $31 million to shepherd a low-risk medical device through the approval process and into the marketplace. For higherrisk devices, the cost of approval more than triples. The medical device tax will only make that process harder -- and more expensive.10 The tax’s impact on jobs may attract the most interest from Democrats. The medical-device industry directly employs 360,000 workers -- and is responsible for another 1.6 million jobs indirectly.11 Those jobs may be casualties of the device tax. Already, several device firms -- including Stryker, Zimmer, and Welch-Allyn -- have announced job cutbacks.12 13 14 Medical-device firms are major employers in states like Massachusetts, Indiana, and Wisconsin -all of which have new Democratic senators. A vote to scrap the device tax by these three senatorial newbies may save the jobs of thousands of their constituents. In December, 18 Senate Democrats sent a letter to Majority Leader Harry Reid (D-Nev.) urging a delay in the implementation of the medical-device tax.15 Massachusetts Senator Elizabeth Warren previously signaled that she would favor just such a repeal.16 Other Democrats, including re-elected Sens. Amy Klobuchar (DMinn.) and Bob Casey (D-Penn.), as well as

Sen. Al Franken (D-Minn.), may join her.17 Fifth, Congress should scrap Obamacare’s Independent Payment Advisory Board (IPAB). This 15-member panel will be empowered to make costcutting recommendations if Medicare spending exceeds a predetermined growth rate. The board’s recommendations automatically take effect -- unless Congress finds equivalent savings elsewhere. But IPAB is not allowed to make any changes to Medicare’s fee-for-service structure or adjust the level of benefits that seniors receive. That leaves just one legitimate cost-cutting tool -- lowering reimbursement rates for participating doctors, nurses, and hospitals. Reimbursements in Medicare are already low -- about two-thirds of the private insurance rate, on average.18 Any additional cuts in payments would cause some providers to curb the number of Medicare patients they’ll see. So IPAB’s cuts would effectively ration care. House Majority Leader Eric Cantor (R-Va.) has called on his colleagues to repeal IPAB, saying, “If we successfully make the case publicly, bills that could reach the president’s desk include . . . repeal of IPAB.”19 And he may be able to attract some Democratic support. A previous effort to scrap the panel attracted more than a dozen Democratic cosponsors.20 *** Not all the action on healthcare reform will be confined to Congress. Several legal chal-

lenges to provisions within the law are currently winding their way through the judiciary. First, there are the more than 40 lawsuits filed by the Catholic Church and numerous other charities, universities, employers, and religious organizations seeking to overturn Obamacare’s requirement that their health plans cover contraception.21 The plaintiffs allege that the Affordable Care Act’s order to cover contraception conflicts with their religious teachings -- and thus violates the First Amendment. In a 2-1 ruling in late December, the Seventh U.S. Circuit Court of Appeals in Chicago blocked the enforcement of the mandate against a construction company owned by two devout Catholics. By contrast, an appeals court in Denver ruled against a private employer seeking exemption from the contraceptive mandate.22 All told, ten of the 13 for-profit companies that have sued in order to avoid paying for birth control coverage have won.23 But several religious entities, including the Catholic dioceses of Nashville and Pittsburgh, have suffered losses in district court, with the judiciary ruling that they do not have standing to sue until the mandate actually takes effect, in 2014.24 A district court in NewYork disagreed with this interpretation, saying that the diocese there may experience harm even before the mandate takes effect.25 And an appeals court in Washington, D.C., ordered the federal government to determine which groups will have to provide contraceptive coverage -- and which will be exempt.26 27 In the meantime, two colleges challenging the mandate will not have to comply with it.28 Given the divergent rulings, the Supreme Court may soon be compelled to consider the matter and issue a final judgment. The U.S. Supreme Court has also ordered the Fourth Circuit Court of Appeals to move ahead with a case filed by Virginia’s Liberty University objecting to both the contraception mandate and the employer mandate, which requires firms with more than 50 workers to provide health coverage or pay a penalty.29 30 For the purposes of calculating the penalty, a firm’s first 30 workers are exempt. A full-time employee is deemed to be one who works 30 or more hours per week. If Liberty loses, then its lawyers could immediately appeal to the U.S. Supreme Court. Oklahoma’s Attorney General Scott Pruitt is also pursuing a challenge to the employer mandate. Obamacare assesses a financial penalty against employers who do not provide affordable insurance if their employees obtain coverage subsidized by the federal government through the new exchanges. Oklahoma has declined to set up an exchange -- and so Pruitt argues that employers in his state should not be subject to the employer mandate.31 The Oklahoma lawsuit also challenges the Affordable Care Act’s subsidies. As written, Obamacare dictates that federal subsidies must be

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FEATURES distributed through state-based insurance exchanges.32 But Oklahoma, among many other states, has promised not to establish exchanges and is leaving it to the federal government to do so. The law makes no mention of distributing subsidies in exchanges operated by the federal government. Pruitt’s lawsuit holds that subsidies therefore can’t be distributed through the federally run exchanges. Thus far, 25 states have opted for such exchanges. The Internal Revenue Service has issued regulations providing for the dispensation of subsidies through federal exchanges. But according to the text of the Affordable Care Act, the tax-collecting agency doesn’t have the power to do so.33 *** No policy overhaul of the size and scope of the Affordable Care Act comes into the world fully formed. Even Democrats have tepidly acknowledged that the law could use some refinement. And while President Obama won re-election, he won’t be able to effectively govern without compromising on some key issues -- the implementation of his health reform among them. It’s safe to say that he’ll be hearing from some angry Americans if Obamacare proceeds to raise the cost of their health care -- as it looks set to do. Indeed, the president may look back and conclude that passing the law was the easy part. The verdict on Obamacare has yet to be written. If the president would like to make sure that he does not leave behind a legacy of absolute chaos in the American healthcare marketplace, he’d be wise to work with Congress -- Republicans and Democrats alike -- to fix the law’s most serious flaws. References 1. “Health Care Costs: A Primer,” Kaiser Family Foundation, May, 2012, p. 9, http://www.kff. org/insurance/7670.cfm (accessed November 2012). 2. Geisa, Kurt and Jason Grau, “Impact of the Patient Protection and Affordable Care Act on Costs in the Individual and Small-Employer Health Insurance Markets,” 3. http://aspe.hhs.gov/poverty/12poverty. shtml (accessed January 2013). 4. Holtz-Eakin, Douglas, “The Growing Budget Cost of Insurance Subsidies in the Affordable Care Act,” American Action Forum, October 2012 5. “Eligibility.” Medicaid. http://www.medicaid. gov/AffordableCareAct/Provisions/Eligibility.html 6. Congressional Budget Office, Estimates for the Insurance Coverage Provisions of the Affordable Care Act Updated for the Recent Supreme Court Decision, http://www.cbo.gov/sites/default/files/ cbofiles/attachments/43472-07-24-2012-CoverageEstimates.pdf .

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7. Haislmaier, Edmund F. and Brian Blase, “Obamacare: Impact on States,” The Heritage Foundation, July 1, 2010, http://www.heritage. org/research/reports/2010/07/obamacare-impacton-states (accessed November 2012). 8. Pipes, Sally. “The CBO Just Rendered Its Verdict On The Cost Of Obamacare, And It Isn’t Pretty.” Forbes. 9. Foster, Richard, “Estimated Financial Effects of the ‘Patient Protection and Affordable Care Act’ as Amended,” Center for Medicare and Medicaid Services, April 22, 2010. 10. Makower, Josh, Aabed Meer, and Lyn Denend , “FDA Impact on US Medical Technology Innovation,” Stanford University, November, 2010, http://www.advamed.org/NR/ rdonlyres/040E6C33-380B-4F6B-AB58-9AB1C0A7A3CF/0/makowerreportfinal.pdf . 11. “State Impacts of the Medical Technology Industry,” The Lewin Group, Inc., June 7, 2010, http://www.advamed.org/NR/ rdonlyres/EE11D3FF-3FCF-4AA8-A4D8C0B4992A5950/0/(accessed November 2012). 12. “Stryker to begin New York layoffs ahead of the medical device tax.” Mass Device. http://www. massdevice.com/news/stryker-begin-new-yorklayoffs-ahead-medical-device-tax-wall-street-beat. 13. Sarvestani, Arezu. “Zimmer axes jobs to cut costs ahead of med-tech tax.” Mass Device. http:// www.massdevice.com/news/zimmer-axes-jobs-cutcosts-ahead-med-tech-tax-personnel-moves. 14. Hannagan, Charlie. “Welch Allyn job cuts are related to new tax mandated by health care law.” Post-Standard (Syracuse), September 10, 2012. 15. http://online.wsj.com/public/resources/documents/MedDeviceLetter12102012.pdf. 16. “Mass. Sen. hopeful Elizabeth Warren on the device tax, the FDA and a climate for innovation.” Mass Device. http://www.massdevice.com/blogs/ massdevice/mass-sen-hopeful-elizabeth-warrendevice-tax-fda-and-climate-innovation (accessed November, 2012). 17. Rubin, Richard, and Kathleen Hunter. “U.S. Medical Device Backers Face Tough Health Care Vote.” Bloomberg. http://www.bloomberg.com/ news/2012-06-06/u-s-medical-device-backers-facetough-health-care-vote.html 18. Shatto, John, and M. Kent Clemens. “Projected Medicare Expenditures under Illustrative Scenarios with Alternative Payment Updates to Medicare Providers,” Center for Medicare and Medicaid Services, May 18, 2012. 19. Viebeck, Elise. “Cantor vows bill to repeal health law’s contentious board - The Hill’s Healthwatch.” Healthwatch. 20. McCarthy, Meghan. “Does Congress Need IPAB?.” Health Care Experts. http://healthcare. nationaljournal.com/2012/03/does-congress-needipab.php (accessed November, 2012). 21. Egelko, Bob. “Contraception coverage heads to high court.” San Franscisco Chronicle, January 11, 2013. 22. Ibid. 23. Smietana, Bob. “Battle continues over contra-

ceptive mandate.” USA Today, January 10, 2013. 24. Ibid. 25. Ibid. 26. Egelko, “Battle continues over contraceptive mandate.” 27. Denniston, Lyle. “Partial win against birth control rule.” SCOTUSblog. http://www.scotusblog. com/2012/12/partial-win-against-birth-controlrule/ (accessed January, 2013). 28. Ibid. 29. Haberkorn, Jennifer, and Kathryn Smith. “SCOTUS orders appeals court to hear Liberty University health care lawsuit .” Politico. http://www.politico.com/news/stories/1112/84226.html (accessed January, 2013). 30. “Affordable Care Act Still Faces Legal Challenges, Resistance From States.” California Healthline. http://www.californiahealthline.org/ articles/2012/11/13/affordable-care-act-still-faceslegal-challenges-resistance-from-states.aspx 31. Ibid 32. Geisel, Jerry. “Oklahoma lawsuit targets premium subsidy provision of health care reform law.” Business Insurance. www.businessinsurance.com/ article/20121028/NEWS03/310289979 33. Adler, Jonathan, and Michael Cannon. “Taxation Without Representation: The Illegal IRS Rule to Expand Tax Credits Under the PPACA,” Working Paper 2012-27.

Sally Pipes is the President, CEO, and Taube Fellow in Health Care Studies at the Pacific Research Institute. Her latest book is The Pipes Plan: The Top Ten Ways to Dismantle and Replace Obamacare (Regnery 2012).

FEATURES Regulatory Burdens of the Affordable Care Act >>> Laxmaiah Manchikanti, MD, Joshua A. Hirsch, MD The Affordable Care Act, or Obamacare, is a historic comprehensive health care reform bill, the first of its nature for the United States. This legislation has survived a challenge in the Supreme Court and, with the reelection of Barak Obama, is poised to move forward. Obamacare has many features that appear attractive, principally the extension of insurance coverage to previously uninsured individuals. However, the empowerment of certain segments of the health care industry, improper application of regulations, and the ability to provide minimal coverage without accountability in addition to regulatory burden may result in adverse consequences, both intended and unintended.

arch 23, 2010, the day President Obama signed into law the first US comprehensive health care reform bill, the Patient Protection and Affordable Care Act, will be celebrated as a historic date in US history. 1 Obamacare was enacted in an attempt to resolve the major problems of US health care; namely, an estimated 50 million Americans who are uninsured, health care costs rising at unaffordable rates, and gross inconsistencies in the quality of care. With the US Supreme Court’s affirmation of the legality of Obamacare and the subsequent reelection of President Obama for a second term, the future of the ACA is no longer in doubt. Critics of the law note that Obamacare may not solve several of the major underlying challenges confronting health care in the US – increasing costs and decreasing quality. Empowering insurers and hospitals may control some provider costs, but it is not clear that overall health care costs will diminish. Similar to any other law, the ACA comes with numerous regulations. In combination with the American Recovery and Reinvestment Act of 2009, 2 and prior regulations, 3,4 the ACA will have a significant adverse effect on the practice of medicine. While this legislation will provide insurance for a greater number of Americans, the actual coverage and reimbursement for many conditions and procedures will be either diminished or eliminated, increasing the burden on both providers and patients. The cost of doing business for many practices will increase as reimbursements decline. This will invariably reduce access and quality of care. While the hospitals

and insurers involved in writing these regulations will see some benefits, they too will be affected by regulatory burdens. Additionally, critics raise concerns that medical professional independence could diminish with the ACA. In reality, that independence has already been eroded with the enactment of multiple regulations such as the Health Insurance Portability and Accountability Act (HIPAA) of 1996 3 and the Balanced Budget Act of 1997 (BBA). 4 As part of the BBA, 4 Congress, for the very first time, enacted a unique statutory restriction on the ability of doctors and Medicare patients to contract privately with each other for the delivery of medical services outside of the Medicare program. Similarly, Congress passed HIPAA with the simple aim of protecting workers who lose their jobs and might be denied new coverage, with guaranteed access to health insurance. With privacy and security regulations and fraud and abuse enforcement, however, this law went far beyond what its name and purpose implies. For physicians and other affected organizations, HIPAA compliance has been costly and has served as a representative example of concerns associated with physician regulatory burden as an unintended consequence of legislation. In fact, many of these efforts have been compared to Y2K preparation in terms of effect and costs. It is quite probable that HIPAA costs, estimated to be $18 to $35 billion when the legislation was passed, may have already exceeded $1 trillion. In a 2012 report, 5 the enormous toll of HIPAA on research was described, highlighted by the Institute of Medicine’s

charge that HIPAA fails to protect privacy and creates significant barriers to research. However, the fraud and abuse program has been a bonanza to the federal treasury, yielding $17 for each $1 spent. 6 According to opponents of the ACA, 7,8 the legislatoin empowers bureaucratic micromanagement and price regulations, potentially exacerbating current health care affordability and delivery problems. Moffit 7 noted that there are over 100 sections of the law dealing with various aspects of Medicare programs, ranging from changes in payments for physician services for hospitals and other organizations to expensive regulatory compliance measures. Several programs have a direct effect on the practice of medicine by essentially increasing the federal supervision of medicine and diminishing the independence of the medical profession. It should be noted that this type of federal involvement was explicitly rejected when Medicare was enacted in 1965. The major regulations affecting medicine are electronic medical records (EMRs); the Patient-Centered Outcomes Research Institute (PCORI) 9 and comparative effectiveness research (CER); the Independent Payment Advisory Board (IPAB); 10 the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10); 11 and multiple Medicare and Medicaid regulations concerning reimbursement and implementing controls on fraud and abuse. 12 In fact, in October 2009, a Thompson Reuters report showed that the health care system wastes between $505 billion and $850 billion every year, an estimated one-third of the nation’s health care bill. 12

Electronic Medical Records Implementation While the authors may personally agree that EMR implementation should, in theory, improve documentation and thus, patient care along with a potential reduction of costs, it is difficult to find evidence that these statements are true. In fact, national EMR implementation will be difficult and expensive. Physicians near retirement not currently using an EMR system may stop practicing in lieu of this expensive upgrade. The $1.2 billion provided by the federal government under the Stimulus Act 2 to help offset EMR costs is almost certainly insufficient.

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Ever-expanding regulations and EMRs costing around $25,000 translates to $7.5 billion every two to three years just for practicing physicians across the US. In fact, eliminating federal regulations without meaningful use alone may save the public upwards of $7.5 billion. Furthermore, most medical directors do not trust the documentation provided by EMRs. This documentation may be useful for fraud and abuse, but the additional regulations will not be enough for the expenses incurred. What many do not recognize is that the changing documentation regulations will also increase costs since the entire EMR will have to be revised. This will be extremely cost prohibitive. Especially in the short-term, physicians implementing EMR tend to see decreases in productivity due to increases in labor costs. Many publications have introduced doubts about the benefits of EMRs. In a project initiated by the Office of the National Coordinator for Health Information, surveyors found that hospital administrators and physicians who had adopted EMR noted that any gains in efficiency were offset by reduced productivity. Additionally, a greater number of information technology staff were needed maintain the system. 13 The Congressional Budget Office concluded that cost savings may occur only in large integrated institutions like Kaiser Permanente, and not in small physician offices. In 2007,

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the Government Accountability Office reported that there was a “jumble of studies and vague policy statements but not (an) overall strategy to ensure that privacy protections would be built into computer networks linking insurers, doctors, hospitals, and other health care providers.” 14 Ardent critics state that there are too many disadvantages to EMRs. They claim EMRs will affect access to health care. EMR implementation is meeting resistance from major decision-makers and physicians themselves, the “EMR mandate” notwithstanding. ICD-10 ICD is a coding system for medical providers to support diagnosis and procedures in electronic administration transactions for insurance coverage. 10 The newest version, ICD-10, which was to be implemented October 1, 2013, will now be implemented October 1, 2014, replacing the ICD-9 code set created in 2003 by HIPAA. There are major concerns in reference to ICD-10. ICD-10 is much more complex than ICD-9 and could cost each physician in the range of $25,000 to $50,000 to implement. Opponents also argue that beyond the new software and hardware requirements, it will also be costly in terms of administrative and medical staff training, and has the potential to delay reimbursements. For example, this new system, which is federally

mandated and based on a weak interpretation of the 2003 HIPAA, contains over 141,000 codes – a 712% increase over the approximately 20,000 ICD-9 codes. Published statistics illustrate that there are approximately 119 instances where a single ICD-9 code can map to more than 100 distinct ICD-10 codes, and there are 255 instances where a single ICD-9 code can map to more than fifty ICD-10 codes. To add to the confusion, there are 3,684 instances in the mapping for diseases where a single ICD-10 code can map to more than one ICD-9 code. Proponents of the ICD-10 system argue that its granularity should lead to improvements in the quality of health care due to more precise coding, reflecting more accurate and actual patient conditions. This will then permit smarter and more efficient disease management. Detractors see the same granularity as burdensome and expensive. These detractors argue that by burdening providers with additional expense and increased administrative time, that the providers are ultimately distracted from using that time to enhance patient care. Independent Payment Advisory Board A common theme in the ACA has been the need for a board of impartial experts to oversee the health care system. Market forces alone, it is argued, cannot control health care costs.Congress is too driven by special interest politics and too limited in expertise and vision to control costs. 15 Consequently, the ACA created the IPAB to meet the need of overseeing health care costs. The legislation established specific target growth rates for Medicare and charged the IPAB with assuring that Medicare expenditures stay within these limits. The IPAB must also make recommendations to Congress regarding how to control health care costs more generally. 15 While there are many critics and detractors, some have considered the IPAB as Congress’s “good deed.” 16 Henry J. Aaron, writing in the New England Journal of Medicine,16 describes that among the most important attributes of legislative statesmanship is “self-abnegation -- the willingness of legislation to abstain from meddling in matters they are poorly equipped to manage.” He believes that the law creating the Federal Reserve embodied that virtue, which is now replicated by the IPAB, even though it is not bipartisan legislation.

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The powers of the IPAB are restricted to a great extent, and multiple sectors of health care or special interests have been protected under the law. The IPAB’s central theme is based on recommending policies to Congress to help Medicare provide better care at a lower cost. This includes ideas on coordinating care, getting rid of waste in the system, providing incentives for best practices, and prioritizing primary care, all of which are based on conjecture, not evidence or experience. Congress then has the power to accept or reject these recommendations. However, Congress faces extreme limitations. It can either enact policies that achieve equivalent savings or let the Secretary of Health and Human Services follow the IPAB’s recommendations. The origins of the IPAB are found in the ideology of the United Kingdom’s National Institute for Health and Clinical Excellence (NICE), even though the IPAB’s authority seems to be limited to Medicare only. In addition, the IPAB has been considered a duplication of efforts; President Obama declared that the IPAB is the Medicare Payment Advisory Commission on steroids. The board membership consists of fifteen full time members appointed by the president and confirmed by the Senate with options for recess appointments. The IPAB statute essentially sets target growth rates for Medicare spending with an applicable percent for maximum savings of 0.5% for 2015, 1% for 2016, 1.5% for 2017, and 1.5% for 2018 and later. Douglas Holtz-Eakin, former CBO Director, in his discussion about the IPAB and access to health care, 17 writes that the mission of the IPAB is too narrow, that it is effectively unaccountable, and that its time horizon is too short. He says that a less generous character-

ization is that the IPAB stands for Independent Price-Controls Advisory Board rather than Payment Advisory Board. According to Holtz-Eakin, the mission is too narrow because the board is prohibited from recommending changes that would reduce payments to certain providers before 2020, especially hospitals – a special interest group heavily involved in shaping the ACA. Because of the directives and restrictions written into law, reductions achieved by the IPAB between 2013 and 2020 are likely to be limited. Holtz-Eakin says that the IPAB is effectively unaccountable since the law makes it almost impossible for Congress to reject or modify the IPAB’s decisions, even if those decisions override existing laws and protections passed by Congress. Consequently, instead of being an advisory board, it is a policy maker. Finally, the IPAB’s time horizon is too short because the cuts have to be achieved in one-year periods. These limitations effectively eliminate long-term quality improvements or preventive programs that actually work, as opposed to just facelifts. Consequently, the IPAB will be forced to focus only on reducing reimbursements to providers due to their short-term nature – primarily to physicians, since hospitals are exempt until 2020. Patient-Centered Outcomes Research Institute The PCORI was established by the ACA to promote CER, with the goal of assisting patients, clinicians, purchasers, and policy-makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diag-

nosed, treated, monitored, and managed through research and evidence synthesis. The PCORI was created as a nonprofit corporation and is neither an agency nor an establishment of the US government. While the PCORI’s mission is supporting the production of well-validated scientific evidence to assist the nation in making informed decisions about a broad range of health care-related issues, it may be duplicating the efforts of the Agency for Healthcare Research and Quality (AHRQ) and wide ranging programs administered by AHRQ. The PCORI and CER, while possessing proper goals, may result in eliminating care by an entire specialty based on inappropriate application of evidence synthesis and bias. Based on the assessment of the literature, as it is performed by AHRQ now, government and payers may decide to restrict health care. The prime examples are mammography screening and screening for prostate cancer. While methodological standards are crucial in assessing evidence, even well established programs such as NICE and AHRQ suffer due to insufficient involvement of clinicians and major misunderstandings about methodology and study design, leading to misinterpretation of evidence. Sadly, the guidance developed by the Institute of Medicine (IOM) in preparing guidelines and systematic reviews is often ignored by the same methodologic experts when interpreting the evidence. 18,19 Accountable Care Organizations Spurring the creation of Accountable Care Organizations (ACOs) was a significant initiative in the ACA. 20 The major goal of ACOs is to achieve cost controls with potential efficiencies by having health care delivery coordinated by hospitals, physician groups, clinics, and health care systems. ACOs are in theory an attractive solution to problems stemming from the complexity and fragmentation of the health care delivery system. Consequently, with good information systems and compensation arrangements, vertical integration of complementary health care entities may achieve greater efficiency by reducing medical errors, obviating duplicative services and facilities, and coordinating elements needed to deliver high quality, patient-centered care. Contrary to the above assumptions, ACOs may provide duplicative, and

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FEATURES at times, unnecessary services, even for borderline indications. Organizations of ACOs are forging collaborations among entire markets of physicians and hospitals, entities that would otherwise compete with each other. 20 Consequently, extraordinary forces in the form of health sector monopolies with horizontal consolidation in the form of ACOs could potentially undermine a good policy idea. 20 The Centers for Medicare and Medicaid Services recognize that as independent physician practices are purchased by hospitals, costs for providing care will escalate for the simple reason that in that environment, the billing schema is different. Summary The ACA of 2010 is a historic law that provides insurance coverage to millions of uninsured patients, yet fails to improve coverage and quality. Some might be justifiably skeptical that this many great initiatives can be achieved while lowering the cost of providing care. The regulatory burden being foisted on providers is seldom discussed. This regulatory burden is best understood in the context of the multiple, expensive, and time-consuming administrative requirements that are occurring independent of the ACA. Many of these initiatives are “good ideas” but are neither presented in the context of an operational context nor based on evidence. It is certain that the vast resources required of physicians under ACA are not necessarily provided concurrently with the new requirements. We, the authors, appreciate this opportunity to share our thoughts on some of the regulatory requirements of the ACA. Indeed, the editors set the stage by suggesting the title include “regulatory burdens.” This sagacious request suggests that policy experts are becoming aware that the operational burden of carrying this regulatory weight may further encumber the system, lest we focus on it as its own unique issue. References 1. Public Law No: 111-148: H.R. 3590. Patient Protection and Affordable Care Act, March 23, 2010. 2. American Recovery and Reinvestment Act of 2009 (AARA), P.L. 111-5, February 17, 2009. 3. Health Insurance Portability and Accountability Act (HIPAA) of 1996, P.L. 104-191, August 21, 1996.

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4. H.R. 2015. Balanced Budget Act of 1997. P.L. 105-33, August 5, 1997. 5. Patlak M, “The costs of HIPAA: To patients, to progress, and to the nation’s health,” C-Change, 2012. http://c-changetogether.org/Websites/cchange/images/ HIPAA/C-Change_HIPAA_Cost_Study_ web_version_8_12_short.pdf (12 November 2012). 6. HHS OIG. Annual performance report: fiscal year 2008 [Internet]. Washington (DC): HHS OIG; 2007 Oct 1–2008 Sep 30 [cited 2009 Jun 4]. p. 6. https://oig.hhs. gov/publications/docs/budget/FY2008_ APR.pdf 7. Moffit RE, “Doctors, patients, and the new Medicare provisions,” Heritage Foundation, December 14, 2009. www. heritage.org/research/testimony/doctorspatients-and-the-new-medicare-provisions (12 November 2012). 8. Moffit RE, Capretta JC, “How to fix Medicare: A new vision for a better program,” Heritage Foundation, December 13, 2010. www.heritage.org/Research/ Reports/2010/12/How-to-Fix-MedicareA-New-Vision-for-a-Better-Program (12 November 2012). 9. Manchikanti L, Falco FJ, Benyamin RM, Helm S 2nd, Parr AT, and Hirsch JA, “The impact of comparative effectiveness research on interventional pain management: Evolution from Medicare Modernization Act to Patient Protection and Affordable Care Act and the Patient-Centered Outcomes Research Institute,” Pain Physician 14, no. 3 (2011):E249-E282. 10. Manchikanti L, Falco FJE, Singh V, Benyamin RM, and Hirsch JA, “The Independent Payment Advisory Board,” Pain Physician 14, no. 4 (2011):E313-E342. 11. Manchikanti L, Falco FJE, and Hirsch JA, “Necessity and implications of ICD-10: Facts and fallacies, Pain Physician 14, no. 2 (2011):E405-E425. 12. Fox M, “Healthcare system wastes up to $800 billion a year,” Reuters, October 26, 2009. www.reuters.com/article/idUSTRE59P0L320091026 (12 November 2012). 13. RWIF, GWUMC, and IHP Staff, “Health information technology in the United States: The information base for progress,” Robert Wood Johnson Foundation, George Washington University Medical Center, and Institute for Health Policy, 2006. 14. Pear R, “Warnings over privacy of U.S. health network,” New York Times, February 18, 2007. 15. Jost TS, “The Independent Payment Advisory Board,” N Engl J Med 363 no. 2 (2010):103-105. 16. Aaron HJ, “The Independent Payment

Advisory Board--Congress’s ‘good deed’,” N Engl J Med 364 no. 25 (2011):2377-2379. 17. Holtz-Eakin D, “The Independent Payment Advisory Board and access to health care,” American Action Forum, October 2012. http://americanactionforum.org/ topic/independent-payment-advisoryboard-and-access-health-care (12 November 2012). 18. Graham R, Mancher M, Wolman DM, Greenfield S, Steinberg E (eds); Committee on Standards for Developing Trustworthy Clinical Practice Guidelines; Institute of Medicine, “Clinical Practice Guidelines We Can Trust,” The National Academies Press, Washington, DC, 2011. 19. Institute of Medicine (IOM), “Finding What Works in Health Care: Standards for Systematic Reviews,” The National Academies Press, Washington, DC, March 23, 2011. 20. Richman BD and Schulman KA, “A cautious path forward on accountable care organizations,” JAMA 305 no. 6 (2011):602-603.

Dr. Manchikanti is Medical Director of the Pain Management Center of Paducah, Paducah, KY, and Clinical Professor, Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY.

Dr. Hirsch is Vice-Chief of Interventional Care; Depts. of Radiology and Neurosurgery, Massachusetts General Hospital and Associate Professor of Radiology, Harvard Medical School, Boston, MA.

FEATURES Assessing the Health Care Decision >>> Ilya Somin , MA, JD NFIB v. Sebelius was one of the most important federalism rulings in modern history. The Supreme Court upheld the Affordable Care Act’s individual health insurance mandate, but invalidated that law’s provision forcing states to greatly expand their Medicaid programs or lose all federal Medicaid funds. Five justices rightly rejected the federal government’s arguments that the mandate was authorized by the Commerce and Necessary and Proper Clauses of the Constitution. But Chief Justice Roberts erred in upholding the mandate as a tax authorized by the Tax Clause. The Court’s decision has several important implications for the future.

his year’s Supreme Court decision ruling on the constitutionality of the Affordable Care Act was the most important federalism case in decades. An unprecedented total of 28 state governments and numerous different private groups, including the National Federation of Independent Business,1 had filed lawsuits challenging the constitutionality of Act. When one of the cases reached the Supreme Court in NFIB v. Sebelius,2 a narrow 5-4 majority upheld the constitutionality of the Affordable Care Act’s individual health insurance mandate, which requires most Americans to purchase governmentapproved health insurance by 2014 or pay a fine. Chief Justice John Roberts’ decisive swing vote opinion concluded that the mandate was permissible under Congress’ power to impose taxes, even though it was not authorized by Congress’ power to regulate interstate commerce or by the Necessary and Proper Clause. A surprising 7-2 majority invalidated a key provision of the ACA that would deprive states of all federal Medicaid funds unless they greatly expanded their Medicaid programs to encompass all citizens with incomes up to 138% of the poverty line. Chief Justice Roberts was right to reject the federal government’s claims that the mandate was authorized by the Commerce Clause and Necessary and Proper Clause, but wrong to save the mandate by concluding that it is a tax. The Supreme Court majority was also right to partially invalidate the ACA’s Medicaid expansion. Both parts of the Supreme Court’s decision have potentially important implications for the future. NFIB was the latest iteration of a longstanding struggle over constitutional limits on the scope of federal power. Beginning in the early 1990s,3 the conservative majority on the Supreme Court began to enforce structural limits on congressional authority for the first time since the 1930s. Conservative and libertarians scholars and jurists have argued that the courts should confine Congress to the powers granted in Article I of the Constitution. By contrast, the liberal justices on the Court and most liberal commentators outside it, have consistently opposed judicial enforcement of structural limits on congressional power. In their view, Congress has es-

sentially unlimited authority to regulate any behavior that, taken in the aggregate, substantially affects the national economy. In the modern world, that includes virtually any significant human decision. This clash of constitutional visions accounts for the deep division over the health care cases on the Supreme Court and elsewhere. For those who believe that Congress has nearly unconstrained authority to regulate anything that affects the economy, the individual mandate is an easy case. By contrast, defenders of judicial enforcement of limits on federal power emphasized the reality that such limits would be effectively gutted if the Court had accepted the federal government’s position.4 I. The Commerce and Necessary and Proper Clauses. Throughout the litigation over the mandate, the federal government relied primarily on the argument that the law was authorized by Congress’ power under the Commerce Clause, which gives it the authority to regulate “Commerce among… the several States.” Based on the text of the Constitution, a regulation authorized by the Clause must meet two requirements: it has to regulate commerce, and that commerce must be interstate. The individual mandate failed both tests. Not having health insurance is not commerce and also is not an interstate activity. Since the 1930s, the Supreme Court has greatly expanded the reach of the Clause, giving Congress the power to regulate any “economic activity.”5 Ye even the broadest of these cases were still consistent with the common-sense notion that “the power to regulate commerce presupposes the existence of commercial activity to be regulated.”6 The mandate “does not regulate existing commercial activity. It instead compels individuals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce.”7 If Congress can “regulate individuals precisely because they are doing nothing,”8 it could impose virtually any mandate of any kind. It could force people to purchase broccoli, cars, or any other product. Roberts also has a compelling answer to the oft-heard argument that the mandate was justified

by precedents such as Wickard v. Filburn,9 which ruled that the Commerce Clause allows Congress to restrict the amount of wheat a farmer can grow, even if the wheat was never intended to be sold: “The farmer in Wickard was at least actively engaged in the production of wheat, and the Government could regulate that activity because of its effect on commerce.”10 By contrast, “[t]he Government’s theory here would effectively override that limitation, by establishing that individuals may be regulated under the Commerce Clause whenever enough of them are not doing something the Government would have them do.”11 The Chief Justice rejected the federal government’s many arguments to the effect that the insurance mandate is constitutional because health insurance is a special case.12 The most common “health care is special” argument was that health insurance is a unique market because everyone uses health care at some point in their lives, a theory emphasized by numerous defenders of the mandate, including the four liberal justices who supported the Commerce Clause rationale in the Supreme Court.13 Yet this contention relies on shifting the focus from health insurance (the product people are actually forced to buy) to health care, on the ground that the former is just one way to obtain the latter. Pretty much any product government might force you to buy is part of some larger market that is difficult to avoid. To use a much-discussed, not everyone purchases broccoli.14 But we all participate in the market for food.15 The federal government and the four liberal justices also argued that the mandate is authorized by the Necessary and Proper Clause, which gives Congress the power to “make all Laws which shall be necessary and proper for carrying into Execution” other powers granted to Congress under the Constitution. The Supreme Court has long defined the term “necessary” very broadly to include anything that might be “useful” or “convenient.”16 But even a “necessary” law may be unconstitutional if it is not also “proper.”17 As Roberts puts it, “[e]ven if the individual mandate is “necessary” to the Act’s insurance reforms, such an expansion of federal power is not a “proper” means for making those reforms effective.”18 A “proper” regulation is one that can be justified by a logic that does not give Congress virtually unlimited power to adopt any mandate of any kind. As James Madison put it in 1791, “[w]hatever meaning this clause may have, none can be admitted that would give an unlimited discretion to Congress.”19 Unfortunately, the logic justifying the in dividual mandate could equally easily justify a mandate requiring people to purchase virtually any other product, or engage in any other activity. If thehealth insurance mandate is permitted because it is a convenient way to regulate the market in health care, then a broccoli-purchase mandate can be defended as a tool for regulating the market in food. A mandate requiring people to exercise regularly could be justified as a convenient tool for increasing economic productivity and decreasing health care costs. The federal government’s defense of the

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FEATURES III. The Medicaid Decision.

mandate would also make most of Congress’ other enumerated powers superfluous. If the Commerce Clause and the Necessary and Proper Clause give Congress the power to adopt any regulations that might affect commerce in some significant way, then Congress’ has no need for it powers to declare war, raise armies, and coin money. Declaring war, raising armies, and coining money all have major effects on commerce and could be justified as useful or convenient tools for regulating it. A regulation that relies on a rationale that would make much of the rest of the Constitution superfluous cannot possibly be “proper.”20 Some defenders of the mandate have advanced the argument that the Constitution gives Congress the power to address “national problems,” especially those that states supposedly cannot address on their own.21 But nowhere in the Constitution is Congress given a blank check to solve any and all alleged national problems. If Congress were intended to have such a sweeping power, there would be no need for the detailed enumeration of numerous specific congressional powers in Article I. The Framers could instead have replaced the eighteen clauses of Article with a single catch-all National Problems Clause. Moreover, to the extent that this argument relies on the idea that states cannot adopt an individual mandate on their own, it runs into the reality that they are entirely capable of doing so, as Massachusetts did in 2006. If the mandate really does reduce the cost and increase the quality of health care as advertised, state governments have every incentive to adopt it.22 Such a state would be attractive to both individuals seeking lower health care costs, and insurance companies, which welcome the opportunity to operate in a state where people are required to purchase their plans. For these reasons, Chief Justice Roberts ruled that the mandate could not be justified by the Commerce and Necessary and Proper Clauses. In this conclusion, he was joined by a narrow 5-4 majority of the Court.23

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II. Is the Mandate a Tax? Despite rejecting the federal government’s most important arguments for the mandate, Chief Justice Roberts still joined with the four liberal justices to uphold it as a “tax” authorized by Congress’ power to establish taxes.24 This part of the decision came as a surprise to most observers. The tax argument that had been rejected by every lower court that addressed it, including liberal judges who had upheld the mandate on other grounds. Lower courts had consistently ruled that the mandate is a penalty, not a tax.25 Roberts admits that this not the “most natural interpretation” of the law.26 The text of the statute refers to the fine as a “penalty,” not a tax.27 And the Supreme Court has repeatedly distinguished between taxes and penalties, defining the latter as “an exaction imposed by statute as punishment for an unlawful act” or omission.28 The health insurance mandate fits the definition of a penalty almost perfectly: it imposes a fine as punishment for the unlawful refusal to purchase government-mandated insurance. Roberts contends that it not a real penalty because it “is not a legal command to buy insurance,” but merely a requirement that violators pay a fine to the IRS.29 The logic here is weak. Is speeding or jaywalking not really unlawful if the penalty for it is a fine? Roberts also advances three other reasons for claiming that the mandate is a tax rather than a penalty: that the fine is collected by the Internal Revenue Service, that it is not very high relative to the cost of health insurance and therefore not “coercive,” and that there is no requirement of criminal intent.30 None of these distinctions is persuasive. Many penalties require lawbreakers to pay only a small fine, as in the case of numerous traffic tickets. A penalty does not become a tax merely because it happens to be collected by the IRS; if Congress passed a law stating that traffic tickets are to be collected by the IRS, they would not become taxes. Finally, as the dissenters point out, there are many strict-liability crimes on the books for which proof of criminal intent is unnecessary.31

The most surprising aspect of the Supreme Court’s decision in NFIB was that seven justices voted to partially strike down the provision of the ACA requiring states to expand their Medicaid programs to cover all residents with incomes up to 133 percent of the poverty line, or risk losing all federal Medicaid subsidies. The Court ruled that this provision was unconstitutionally “coercive,” acting as a “gun to the head” of the states, which stood to lose federal Medicaid subsidies equal to as much as 10 to 16 percent or more of their total budgets unless they accepted the expansion.32 Congress could still offer states new funds in exchange for expanding Medicaid eligibility, but not take away all their existing Medicaid funding if they refuse the offer.33While previous decisions had noted that “coercive” grants were unconstitutional,34 this was the first use of Congress’ power to spend money that the Supreme Court had invalidated as unconstitutional since the 1930s. In retrospect, this decision should not have surprised as much as it did. If any conditional grant can be invalidated as “coer cive,” it would have to be this one. Virtually all state governments are heavily dependent on federal Medicaid subsidies, and would risk bankruptcy without them. The Court likely struck down this part of the law because the justices believed that the entire coercion framework for assessing federal grants to state governments would be gutted if they upheld it. This may help explain why two liberal justices were willing to join with the five conservatives on this issue, despite their opposition to judicial enforcement of structural limits on federal power in most other contexts. The coercion doctrine applied in NFIB is far from ideal. It is difficult to tell when the terms of a federal offer of conditional grants are so onerous as to be “coercive.”35 But giving Congress completely unconstrained authority to use conditional grants to influence state policy is also highly problematic, since it would severely undermine states’ ability to pursue any policies at odds with those preferred by national political majorities. Had the Supreme Court upheld the Medicaid expansion, a similar “gun to the head” could be used to force states to give up almost any policy that a Congressional majority disapproves of.36 III. Implications. Assuming it is followed by lower courts,33 Chief Justice Roberts’ Commerce Clause and Necessary and Proper reasoning might put some meaningful constraints on Congress’ power to impose other mandates, particularly those that are imposed on people simply because “they are doing nothing.”37 The threat of such mandates is far from purely theoretical. Many industries could potentially lobby for laws requiring people to purchase their products, and Congress has a long history of enacting special interest legislation.38 The political process cannot be relied on to consistently prevent the

enactment of future mandates that benefit narrow interest groups at the expense of the general public. The potential beneficial effects of Roberts’ reasoning are partially undercut by the reality almost any purchase mandate could potentially be restructured to fit his definition of a tax. To qualify, the mandate would have to be enforced only by a monetary fine that is collected by the IRS, is not too high, and levied without regard to criminal intent. At the very least, however, such future mandates could not be enforced by threats of imprisonment or by extremely high monetary penalties. The Court’s invalidation of the Medicaid condition makes it possible that many states will refuse to expand Medicaid coverage, as some have already decided to.39 What is not clear is whether any other federal conditional grant programs may be invalidated as coercive. NFIB is extremely imprecise as to where the boundary between an incentive and a “gun to the head” actually lies. Ultimately, the extremely polarized decision over the ACA proves that there is no consensus on the constitutional limits of federal power, either within the Court or outside it. The only safe prediction is that the political and legal struggle over federalism will continue. References 1. This was the first time that an absolute majority of the states have ever challenged the constitutionality of a federal law in court. 2. 132 S.Ct. 2566 (2012). 3. United States v. Lopez, 549 U.S. 514 (1995) , the first case to limit Congress’ authority under the Commerce Clause in almost sixty years, was a key milestone in the Supreme Court’s 1990s “federalism revival.” 4. Two prominent conservative lower court justices – Jeffrey Sutton and Laurence Silberman did vote to uphold the mandate despite this issue. See Ilya Somin, “A Mandate for Mandates: Is the Individual Health Insurance Case a Slippery Slope?” Law and Contemporary Problems 75 (2012). 75, 81-82. But their opinions relied on reasoning that would have given the Supreme Court unlimited authority to impose virtually any mandate of any kind. Silberman even explicitly recognized this in his opinion upholding the mandate. See Seven-Sky v. Holder, 661 F.3d 1, 18 (D.C. Cir. 2011). This approach was unlikely to find support among Supreme Court justices and others committed to enforcing meaningful limits on federal power. 5. See, e.g., Gonzales v. Raich, 545 U.S. 1 (2005). 6. NFIB, 132 S.Ct. at 2586 (Roberts, C.J.). 7. Id. at 2587. 8. Id. 9. 317 U.S. 111 (1942). Wickard was heavily relied on by defenders of the individual mandate, including the four liberal justices on the Supreme Court. See NFIB, 132 S.Ct. at 2616-17, 2619-21. (Ginsburg, J., concurring in part and dissenting in part). 10. NFIB, 132 S.Ct. at 2588 (Roberts, C.J.).

11. Ibid. 12. For a much more comprehensive critique of the various “health care is special” arguments advanced during the course of the litigation, see Somin, “A Mandate for Mandates, 84-93. 13. See NFIB, 132 S.Ct. at 2619-20 (Ginsburg, J., concurring in part and dissenting in part); For citations to lower court cases making the same argument, see ibid., 84 n.39. 14. The broccoli example was first raised by Judge Roger Vinson, who struck down the individual mandate at the trial court level, and quickly became famous. See Florida ex rel. Bondi v. U.S. Dep’t of Health & Human Servs., 780 F. Supp. 2d 1256, 1289 (N.D. Fla. 2011), aff’d in part, rev’d in part Florida ex rel. Atty. Gen. v. U.S. Dep’t of Health & Human Servs., 648 F.3d 1235 (11th Cir. 2011), rev’d NFIB v. Sebelius, 132 S.Ct. 2566 (2012). 15. As Roberts puts it “[e]veryone will likely participate in the markets for food, clothing, transportation, shelter, or energy..” NFIB, 132 S.Ct. at 2590-91 (Roberts, C.J.). 16. M’Culloch v. Maryland, 17 U.S. (4 Wheat.) 316, 413-15 (1819). 17. For a more extensive explanation of the reasons why the mandate is not “proper,” see Ilya Somin, “The Individual Mandate and the Proper Meaning of ‘Proper’,” in Gillian Metzger, Trevor Morrison, and Nathaniel Persily, eds., The Health Care Case: The Supreme Court’s Decision and its Implications, (New York: Oxford University Press, forthcoming). 18. NFIB, 132 S.Ct. at 2592 (Roberts, C.J.). 19. James Madison, Speech on the Bank Bill, House of Representatives, Feb. 2, 1791, in James Madison, Writings 480, 484, Jack N. Rakove, ed. (New York: Vintage, 1999). 20. For an extensive discussion of the relationship between redundancy and propriety, see Somin,” The Individual Mandate and the Proper Meaning of ‘Proper.’” 21. See, e.g., NFIB, 132 S.Ct. at 2612-13, 2616 (Ginsburg, J., concurring in part and dissenting in part). 22. I discuss this issue in detail in Somin, “Mandate for Mandates,” 90-94, which also rebuts claims that states cannot adopt an individual mandate on their own due to supposed collective action problems. 23. The four conservative dissenters agreed with him on these points. Ibid. 2644-50 (joint dissent). 24. Ibid. 2593-2600 (Roberts, C.J.). 25. For a list of these decisions, see Somin, “Mandate for Mandates,” 87 n.53. 26. NFIB v. Sebelius, 132 S.Ct. at 2594. 27. 26 U.S.C. § 5000A(b). 28. United States v. Reorganized CF&I Fabricators of Utah, 518 U.S. 213, 225 (1996). 29. NFIB v. Sebelius, 132 S.Ct. at 2594. 30. Ibid., 2594-97. 31. Ibid. 2654-55 (joint dissent). 32. Ibid. 2601-2607. 33. Ibid. 34. See South Dakota v. Dole, 483 U.S. 203, 211

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(1987). 35. Elsewhere, I have argued that the Court should use a different approach to enforcing limits on the Spending Power. See Somin, “Closing the Pandora’s Box of Federal: The Case for Judicial Restriction of Federal Subsidies to State Governments,” Georgetown Law Journal 90 (2002): 461. 36. Under current precedent, conditions attached to federal grants need only have a very minimal connection to the policy area addressed by the grant. See, e..g, Sabri v. United States, 541 U.S. 600 (2004). So Congress could potentially use the threat of withholding Medicaid grants to leverage policy changes on issues that are only faintly related to health care. 37. Some have argued that Chief Justice Roberts’ Commerce Clause and Necessary and Proper is not binding on lower courts because it was not necessary to the outcome in this case. So far, most lower courts have rejected this view. See ,e.g., United States v. Elk Shoulder, 696 F.3d 922, 930-31 (9th Cir. 2012). 38. NFIB, 132 S.Ct. at 2587 (Roberts, C.J.). 39. For a fuller discussion of this danger, see Somin, Mandate for Mandates, 93-96. 40. Eight states have already announced that they are rejecting the expansion, and others are considering doing so. See CNN, “Medicaid: States Turning Down Free Money, Group Says,” CNN.com, Nov. 26, 2012, available at http://thechart.blogs.cnn. com/2012/11/26/medicaid-states-turning-downfree-money-group-says/?hpt=he_c2Elise Viebeck, “Fifteen Governors Reject or Leaning Against Expanded Medicaid Program,” The Hill, July 3, 2012, available at http://thehill.com/blogs/healthwatch/ health-reform-implementation/236033-fifteen-governors-reject-or-leaning-against-expanded-medicaidprogram

Ilya Somin is Professor of Law at George Mason University at George Mason University School of Law. He has written extensively on constitutional limits on federal power. He was the author of an amicus brief in NFIB v. Sebelius on behalf of the Washington Legal Foundation and a group of constitutional law scholars. Fall 2012 Volume 13, Number 2

FEATURES Walmartizing Preventive Healthcare Services: a novel approach for lowering costs while improving access, quality and utilization rates >>> Sanjay Saini, MD, McKinley Glover, MD

reater emphasis on preventive healthcare is an important element of the 2010 Patient Protection and Affordable Care Act. As the signature domestic policy accomplishment of the Obama administration during its 1st term, the Affordable Care Act is critical for addressing the main drawbacks of America’s healthcare system, which are equity, cost, and quality. While the rationale for promoting prevention to avoid healthcare spending associated with managing downstream illnesses seems self-evident, the cost-effectiveness of preventive healthcare strategies remains controversial.1,2 For example, low-cost preventive measures such as vaccinations against communicable diseases and PAP smears (Papanicolaou test) for early detection of cervical cancer have been shown to be highly cost-effective.3,4 Therefore many such programs have been near-universally adopted worldwide.3-5 However, higher cost preventive procedures such as colonoscopy for early detection of colon cancer are not widely recommended .6 Indeed the United States is the only country to advocate for colon cancer screening with optical colonoscopy that involves direct visualization of the entire colon into an endoscope inserted into the rectum. Even in the US, novel high-cost tests that are less invasive such as CT scanning for colon cancer or lung cancer have not been adopted due to concerns about affordability.7 Another limitation of current prevention strategies is inadequate penetration rates. For example, moderate-cost screening mammography for early breast cancer detection while shown to lower death rates, suffers from an unacceptably high disparity in screening rates depending upon a woman’s socioeconomic status.8 In this paper we argue that the market for preventive healthcare in healthy subjects should be uncoupled from the market for disease management for patients, with each having its unique economic regulatory framework. In our view a less restrictive economic regulatory environment for preventive health services would lead to innovative business models that could deliver the traditional moderateto-high-cost preventive healthcare services at lower prices. Such an environment could simultaneously increase access of these services for underserved populations and maintain if not enhance quality standards making these tests highly cost-effective. This approach will make preventive healthcare services more attractive for implementation as a public health strategy as envisioned in the 2010 Patient Protection and Affordable Care Act, lowering disease burden and overall national health care expenditures while also improving population health status.

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Lessons from Transportation Deregulation In numerous sectors of the US economy such as transportation, banking and communications, economic deregulation has led to improvements in service levels and quality at lower prices for consumers. Of these, the transportation industry is closest to the healthcare sector because the overall goals are somewhat similar, namely access, cost and safety. In the transportation sector positive outcomes have been documented following economic deregulation both in the airline and the trucking industries. For example prior to 1984, the Civil Aeronautics Board (CAB) was not only the body responsible for airline safety, but also the regulator of airline economic activity such as fares, routes and inter-carrier agreements. After passage of the Airline Deregulation Act in 1978, the CAB officially ceased to exist on Dec 31, 1984. Following deregulation of economic activities airlines became more efficient largely though higher load-factors. As a consequence, fares fell and air-travel dramatically increased. Figure 1 shows the greater than 50% real dollar drop in US domestic airfares,9 while in comparison airfares in Canada remained stagnant due to continued economic regulation. As a result airline travel in the US greatly expanded over the ensuing 25 years with airlines offering services to five times more destinations and transporting more than twice as many passengers. For example, in the year 2009 US carriers transported 770 million passengers (i.e. approximately 2.5 times the US population of 305 million) compared to 275 million passengers in the year 1978 that (approximately 1.25 times the US population of 220 million at that time). More remarkably, various measures of quality such as passenger fatalities and injuries, airplane accidents, mishandled baggage reports and on-time arrival have improved, quite dramatically in some cases. For example according to the 2012 National Transportation Statistics report published by the US Department of Transportation,10 passenger fatalities in US Carrier or Commuter airlines declined from 499 in 1980 to 2 in 2010 (Table 2-1 in report); the number of injured passengers decreased from 81 to 17 (Table 2-2 in report); and the number on airplane accidents decreased from 57 to 34 (Table 2-3 in report). All the while, the number of US carrier aircraft-miles flown increased from 2.9 million to 7.6 million (Table 2-9 in report) with the number of overall flight

departures increasing from 5.2 million to 9.6 million (Table 1-37 in report). Thurs per flight hour rates for fatalities, injuries and accidents are dramatically lower today than were present prior to deregulation (Table 2-9 in report). A similar impact on unit prices has been documented in the trucking industry.11 Prior to economic deregulation by the Motor Carrier Act of 1980 the Interstate Commerce Commission, among other restrictions, required motor carriers to file tariffs 30 days prior to taking effect and required truckers from obtaining operating licenses. The licenses in particular were extremely difficult to obtain. Unsurprisingly, this limited competition. Purchasing ‘rights’ from another trucking firm became the only means of entering a market thereby increasing unit costs. As a result of economic deregulation, truckers increased efficiency and unit prices in transportation of goods as shown in Fig 2 were 50% lower in 1999 compared to 1980.11 In addition, services improved with the evolution of Truck-Load carriers and Less-than Truck Load carriers, the latter permitting affordable door-to-door services that we are familiar with today. Collateral benefits have been documented, as manufacturing firms were able to lower inventory costs through improved logistics of just-in-time supply-chain management. Implications for Preventive Healthcare Services The obvious question that arises is if these benefits of economic deregulation can be adopted by the healthcare sector. In our view there are numerous operational differences between preventive healthcare services that are provided to healthy subjects, and disease management healthcare that is needed by patients. In the latter instance, evidence based medicine is an important concept that increasingly relies on personalized treatment algorithms. In contrast, preventive care recommendations are largely standardized and given to all average-risk subjects with some modification for high-risk individuals.

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Furthermore, given the suboptimal penetration rates for many preventive care services such as mammography, there is a need for more active promotion of these service. Since preventative services are typically low-margin commoditized activities that do not allow healthcare systems to differentiate themselves, they are not widely marketed. Indeed, it may be appropriate for individuals to have greater responsibility for all aspects of their preventive healthcare activities including not only those related to diet, smoking or exercise but also those related early cancer detection such as mammography. This may be particularly appropriate for the healthier younger individuals who are more likely to change jobs, location and healthcare providers. Due to the fragmented nature of the US healthcare system, this approach creates the opportunity for organizing longitudinal preventive healthcare services that are provided by nationally active firms that can track an individual’s prevention history and provide needed preventive healthcare services. Retail Mammography Paradigm Mammography is currently one of the few preventive healthcare services that can be initiated by an individual without a physician referral. Our research shows that healthy women prefer to obtain these services in retail-venue settings such as pharmacies or department stores due to access and greater convenience.12 Our hypothesis is that a retail-venue based business-model for delivering preventive healthcare services might lead to greater efficiency of capital-intensive resources, if price discrimination is allowed allowing higher utilization in off-peak hours. Furthermore to address disparities in preventive healthcare, inducements to patients that are currently illegal should be permitted to encourage subjects to receive recommended preventive care. For this, a secure national database would be needed to ensure that screening is performed at established intervals. With recommendation rates based on evidence-based trials, this approach may be effective for colon-cancer screening with CT or fecal DNA tests which could be readily implemented worldwide. In the future this approach could be applied to emerging high-

cost screening services such as CT for heart disease and MRI for Alzheimer’s disease. Modifications in how these services are promoted and delivered would not need to impact the way physicians impart care, ensuring quality outcomes. So for example if screening mammography were to be performed in a retail-venue setting, the cost of image acquisition could be lowered though higher room utilization rates and longer hours of operation, which would also improve access for working subjects. However, interpretation of images would still be done in the traditional hospital-based setting, thereby ensuring that examination quality is maintained. Since technical image acquisition fees typically are 2-5 times physician fees, the greatest opportunity for lowering healthcare spending is by creating the economic regulatory environment for innovations that lead to higher machine productivity.

Screening in Five Developing Countries. 6. Ransohoff, DF. Colon Cancer Screening in 2005: Status and Challenges. Gastroenterology 2005; 128: 1685-1695. 7. Knudsen, AB, Lansdorp-Vogelaar I, Rutter CM, Savarino JE, van Ballegooijen, Kuntz, KM, Zauber AG. Cost-Effectiveness of Computed Tomographic Colonography Screening for Colorectal Cancer in the Medicare Population. 8. Kim, J, Jang SN. Socioeconomic Disparities in Breast Cancer Screening among US Women: Trends from 2000 to 2005. Journal of Preventive Medicine and Public Health 2008; 41:186-194. 9. Gowrisankaran, G. Competition and Regulation in the Airline Industry. Federal Reserve Bank of San Francisco, Economic Letter 2002. 10. Inited States Department of Transportation, National Transportation Statistics 2012. 11. United States Department of Transportation, Federal Highway Administration. Freight Transportation: Improvements and the Economy. Appendix A: Economic Effects of Transportation: The Freight Story. 2002. 12. Gupta S, Vij A, Cafiero E, Bloom D, Agarwal S, Donelan K, Kopans D, Saini s. Retail Venue Based Screening Mammography: Assessment of Women’s Preferences. Academic Radiology 2012; 19: 12681272.

Conclusion The current approach for restructuring the US healthcare system is to first achieve universal coverage and then reduce overall spending by lowering payments. This, we believe, is likely to fail as has been documented by the unsuccessful implementation of the sustainable growth rate concept. We believe that a more robust way to lower unit costs in healthcare is by creating an operational climate that allows innovation in service organizations. This can only be possible though partial elimination of economic regulations on the facility side while maintaining these regulations on the physician side in order to ensure quality outcomes. References 1. Russell, LB. Preventing Chronic Disease: An Important Investment, but Don’t Count on Cost Savings. Health Affairs 2009; 28: 42-45. 2. Maciosek, MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solberg LI. 31: 52-61. 3. Mandelblatt, JS, Lawrence WF, Gaffikin L, Limpahayom KK, Lumbiganon P, Warakamin S, King J, Yi B, Ringers P, Blumenthal PD. Costs and Benefits of Different Strategies to Screen for Cervical Cancer in Less-Developed Countries. Journal of the National Cancer Institute 2002; 94:1469-1483. 4. Maciosek, MV, Solberg LI, Coffield AB, Edwards NM, Goodman MJ. Influenza Vaccination Health Impact and Cost Effectiveness 2006; 31: 72-79. 5. Goldie, SJ, Gaffikin L, Goldhaber-Fiebert JD, Gordillo-Tobar A, Levin C, Mahe C, Wright TC, Alliance for Cervical Cancer Prevention Cost Working Group. Cost-Effectiveness of Cervical-Cancer

Sanjay Saini, MD is a professor of radiology at Harvard Medical School as well as Vice-Chairman for finance in the Radiology Department at Massachusetts General Hospital.

McKinley Glover, MD is a clinical assistant in radiology at Harvard Medical School.

Fall 2012 Volume 13, Number 2

STUDENT CONTRIBUTIONS Fixing Medicaid: Going Beyond the PPACA >>> Samita Mohanasundaram, AB Candidate Although the Patient Protection and Affordable Care Act (PPACA) is a great first step to reforming health care, Medicaid will still suffer from its fundamental flaws: lack of accessibility, uneven services across states, stigmatized view about the program, and physician reimbursement problems. However, a single payer program that offers universal health care can correct many of Medicaid’s basic flaws while supporting Medicaid’s admirable qualities, such as providing healthcare to children and the disabled, fueling economic growth in states, and offering the Essential Health Benefits.

ealth care reform under the Patient Protection and Affordable Care Act (PPACA) promises several measures to improve Medicaid through program expansion, better financing, disease prevention programs, and community health centers. As states decide whether to expand Medicaid to cover more people and services by 2014 under the PPACA, 1 they should realize that the PPACA is a great first step to Medicaid reform, but it fails to fix the foundational problems that plague Medicaid’s efficiency, 2 leading to the future attrition of both Medicaid and the PPACA. One approach to overcome this dilemma is through a federal government controlled singlepayer system that integrates strong PPACA measures, such as the Essential Health Benefits (core services required in health insurance plans), along with the option of choosing additional services through fees or supplemental private insurance. Covering more than 60 million Americans, 3 Medicaid is one of the largest and most important health programs for our nation. It covers 1 in 3

births, more than 8 million people with disabilities, and 1 in 4 poor non-elderly adults. 4 Additionally, Medicaid offers preventive services for children and funds long-term care as well as community health centers and public hospitals. 5 Because state spending in Medicaid is matched by the federal government, these federal funds from Medicaid help grow economic activity in states. 6 Therefore, if another program were to replace Medicaid, it must not diminish Medicaid’s positive impact on low-income adults and children, individuals with disabilities, state economies, and community medical programs while attempting to remedy the drawbacks of Medicaid. To increase accessibility to health care for lower-income families, reduce the stigma that Medicaid programs usually carry, eliminate uneven funding across states, and increase physician reimbursement to competitive levels while maintaining the current positive impact of the Medicaid program, I propose that a federal program for universal access to health care should be utilized instead of the implementation of the PPACA. This single-payer

program will be run by the federal government and funded by general tax revenues with an option for individuals to buy supplemental insurance for additional fees. Although Medicaid was established to provide health insurance to low-income families and individuals with disabilities who don’t have access to private insurance, many people fail to enroll. 7 Since individuals need to fill out paperwork to qualify, there are several problems that arise. First, qualified individuals may have trouble completing the application process due to language, education, technological, or travel barriers. Second, because Medicaid is a program for the indigent, many qualified people may decide not to enroll in fear of social embarrassment. 8 Under the PPACA, Medicaid will be expanded to all individuals under 133% of the Federal Poverty Level (FPL). Furthermore, individuals with incomes between 133% and 400% of FPL will receive subsidies for the purchase of insurance.9 This will aid millions who are currently uninsured because they do not qualify for Medicaid and cannot afford private insurance. However, the PPACA does not address the fundamental problem of access to Medicaid. My proposed universal federal program that provides everyone access to a basic health insurance plan10 that includes the Essential Health Benefits, such as emergency care and pediatric services, is a better solution to Medicaid. Since everyone will be entitled to a basic plan in the market, this type of program would significantly reduce the number of uninsured by enabling universal access to health care. Furthermore, everyone will be enrolled in this program regardless of their economic background, which would eliminate additional paperwork for only certain populations and diminish the stigma that only the poor enroll in the program. The basic nature of the Medicaid program is flawed: it is a program for the poor funded by the rich.11 As the third largest domestic program in the U.S. federal budget, Medicaid is often scrutinized in deficit reduction efforts. In fact, the House of Representatives passed a budget plan in 2011 and 2012 that would cap federal Medicaid payments to states and limit the growth of the program, at a time of increasing enrollment and rising health care costs.12 The President’s 2013 budget proposal states that more than $60 billion will be cut from Medicaid over the next ten years. Limitations on provider taxes, Children’s Health Insurance Program, reimbursement of medical equipment, and lower hospital payppayments could go into effect after 2021. 13 On the other hand, states are also under budget pressures, and many are restricting provider payment rates and optional benefits for Medicaid costs. 14 If block grants are used to shift costs to states, as proposed by the House, states may have trouble providing adequate Medicaid services. The poor and lower-income families have little influence in Washington, D.C. and rely on the financially stable to provide political support for

Fall 2012 Volume 13, Number 2

STUDENT CONTRIBUTIONS Medicaid funding. Because politicians are more inclined to support programs that target a broad range of individuals, not just the poor, Medicaid often gets short-changed in government budgets. 15 My proposed federal program where everyone receives the same basic coverage ensures that every individual, regardless of socio-economic background, will have a stake in the program. Therefore, this program will have a better future in governmental budget cuts because it does not just support a small group of people rarely represented in Washington. Since Medicaid is a federal and state government partnership, disparities of coverage arise among wealthier and poorer states. For example, the Medicaid eligibility income threshold for working parents is less than 25% of FPL for Alabama, but over 200% of FPL for Minnesota. 16 Furthermore, Medicaid is a counter-cyclic program, so more people are eligible during the economic downturn, which is also the time that states are cutting down on spending. 17 Under the PPACA, Medicaid will be expanded to cover 17 million more people by 2016 and a national floor for Medicaid eligibility will be established. Moreover, 95% of new Medicaid coverage from 2014 to 2019 will be financed by the federal government.18 Although this will increase enrollment and decrease the number of uninsured, disparities will still persist because states will continue to manage the implementation of Medicaid. The U.S. Department of Health and Human Services has announced that each state will be able to determine the essential benefits packages required in health care plans. 19 However, these broad categories of benefits will further increase the Medicaid quality disparities across states. On the other hand, a federal government controlled system would fix the problem of allowing administration to the states. I propose that the federal government should completely fund the program through general tax revenues and allow individuals to purchase supplemental coverage to tailor services to their needs, which may not be covered in the Essential Health Benefits list. Removing states from the funding aspect of the program will create more equitable coverage, but will also continue to stimulate the economies of states by bringing revenues to health care facilities and supporting jobs. Medicaid patients often have difficulties finding physicians who will accept their plan. As healthcare costs rise, states often choose to cut reimbursement rates, deterring doctors from accepting more Medicaid patients. 20 Studies have shown that physicians that actively serve Medicaid patients are the most willing to accept new Medicaid patients, but many have reached capacity and can’t serve more patients. 21 Under the PPACA, more than 30 million newly insured people are expected to enter the health care system. 22 This will increase the competition of finding a physician, which could put Medicaid patients at a disadvantage compared to private insurance beneficiaries. The PPACA also guarantees that in 2013 and 2014, Medicaid

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reimbursement rates for physician services will be the same as Medicare’s payment levels. 23 Although this is an encouraging plan that will help more individuals on Medicaid to get access to physicians, there are a few problems. First, the reimbursement rates under the PPACA for Medicaid are not as high as those for private insurance, so Medicaid patients may still find it difficult to find a physician in some areas. Second, the PPACA only guarantees the increase in reimbursement rates for two years.24 Since the federal government plans to finance 95% of the costs of new Medicaid enrollees from 2014 to 2019, 25 there will be many people joining Medicaid after 2014 that will not receive the benefits of the increased reimbursement rate. However, my proposed single payer plan run by the federal government would entitle all individuals to a basic health care plan with reimbursement rates competitive with those of private insurance, ensuring that patients have better access to physicians. Today Medicaid supports about twenty percent of the U.S. population, but even with the implementation of the PPACA, Medicaid will still carry many of its fundamental flaws. Replacing Medicaid with a federal system that offers universal health care will eliminate the basic flaws that Medicaid faces - lack of accessibility, uneven services across states, stigmatized view about the program, and physician reimbursement problems. However, the federal program will still support many of the admired measures of Medicaid and the PPACA, including health care to children and people with disabilities, fueling economic growth in states, and offering the Essential Health Benefits program at the lowest-priced insurance plans. References 1. Pam Belluck, “Medicaid Expansion May Lower Death Rates, Study Says,”New York Times, July 25, 2012 2. David Orentlicher, “Rights to Healthcare in the Untied States: Inherently Unstable,” American Journal of Law & Medicine 38(2012): p. 344. Samita Mohanasundaram, Page 7 of 7 3. Kaiser Family Foundation, “The Medicaid Program At a Glance” September 2012, p. 1. 4. Kaiser Family Foundation, “Medicaid Matters: Understanding Medicaid’s Role in Our Health System”, March 2011. p. 1. 5. Kaiser Family Foundation, “How is the Affordable Health Care Act Leading to Changes in Medicaid Today?”, May 2012, p. 1 6. Mary Ruggie, “Medicaid” (lecture, Harvard College, Cambridge, MA, September 24, 2012). 7. Orentlicher, p. 332. 8. Orentlicher, p. 332 9. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p.6

10. Orentlicher, p. 346 11. Orentlicher, p. 336 12. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p.5 13. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p.5 14. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p. 4 15. Orentlicher, p. 337 16. Mary Ruggie, “Medicaid” (lecture, Harvard College, Cambridge, MA, September 24, 2012). 17. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p. 5 18. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p. 6 19. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p. 5 20. Orentlicher, p. 336 21. Kaiser Family Foundation, “Physician Willingness and Resources to Serve More Medicaid Patients”, April 2011, p. 2 22. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p. 6 23. Kaiser Family Foundation, April 2011, p. 1 24. Mary Ruggie, “Medicaid” (lecture, Harvard College, Cambridge, MA, September 24, 2012). 25. Kaiser Family Foundation, “5 Key Questions About Medicaid and Its Role in State/Federal Budgets & Health Reform,” May 2012, p. 6

Samita Mohanasundaram is a junior at Harvard College interested in domestic and global health policy. Through her work in stem cells and public policy, Samita is involved in both the science and policy sides of healthcare

STUDENT CONTRIBUTIONS Covered, California: Branding the California Health Benefit Exchange >>> Erynne Jones, MA Candidate California was the first to announce its intention to implement a state-based Health Insurance Exchange under federal health care reform and has moved quickly to lay the foundations for January 2014 by engaging stakeholders throughout California in the designing, improving, and marketing a meaningful and effective final product. Segmented targeting and ongoing communication with groups throughout the state have been a critical component of this process. California’s road from state health exchange to “Covered California” serves as a model for creating a meaningful brand that other states can draw from in their own design process, regardless of their own population bases.

tates choosing to establish a state-run health insurance exchange had until December 14, 2012 to file an initial application and letter of intent for the program with the federal Department of Health and Human Services (HHS). The Patient Protection and Affordable Care Act (ACA) gives states the option of establishing a state-run exchange or allowing the federal government to set up an exchange on its behalf. Exchanges will theoretically provide consumers seeking insurance coverage the ability to join a state-wide risk pool with competitive pricing, transparent choice, and affordable plans that offer minimum standards of essential benefits with options for varying tiers of coverage. States also have the option of partnering with the federal government to create a jointly-run program, with the federal government providing the bulk of support and the state handling plan management and/or consumer assistance. California was the first state after the passage of the Affordable Care Act to announce its intention to implement a state-based Health Benefits Exchange in September 2010, a mere six months after the law’s passage. Bills were introduced in both houses of the bicameral legislative system supporting the creation of the Exchange in California –Assembly Bill 1602 outlined the structure of the Exchange and requirements for insurers to participate, while Senate Bill 900 established guidelines for the composition of the Exchange’s governing board.5,6 Since the passage of these bills into law, the state has moved quickly to lay the foundations for the official launch of its Exchange in January 2014, establishing a five-member Board of Directors to manage the activities of the organization and engage stakeholders throughout California in the process of designing, improving, and marketing the final product. As other states begin or continue the process of designing their own state exchanges, California’s road from state health exchange to “Covered California” serves as a

model for creating a meaningful brand that other states can draw from in their own design process, regardless of their respective population bases. Laying the Foundation California’s Health Benefit Exchange Board was eager to create a brand for California’s Exchange that inspired trust, accessibility, and affordability. This required the selection of a name that would capture the values underlying the concept of the Exchange and inspire consumer confidence. The Executive Director of the Health Benefit Exchange Board, Peter Lee, stated in a 2012 interview that in its selection, the Exchange hoped to pinpoint “a name that’s going to stick, that’s going to grab hold, that all Californians are going to say, ‘Boy, that’s where I go to find health care.’”7 The Exchange invested $900,000 into its initial outreach efforts, contracting with Ogilvy Public Relations to engage stakeholders through an aggressive outreach, marketing, and educational campaign.8 This included comprehensive research

on understanding who the target population actually was and what their needs were. While marketing would mainly be geared towards those eligible for federal subsidies under the ACA or seeking to determine eligibility for other public programs, efforts also needed to be made to inform those above 400% of the Federal Poverty Level (FPL); the threshold for federal subsidies for the Exchange) of the ease of use that the Exchange would offer in purchasing individual insurance plans and comparing competing insurance options. Engaging stakeholders in the process of building the foundations for the Exchange’s final design was a key component in selecting an appropriate brand and identifying channels through which to reach the largest number of potential enrollees. A series of standing meetings with the Exchange’s Project Sponsors – representatives from the Exchange, the California Department of Health Care Services (DHCS) and the Managed Risk Medical Insurance Board (MRMIB) – helped to identify existing practices and to integrate existing public programs into the health exchange marketplace for eligible populations.9 Additional input was gathered through written communications with Project Sponsors, open public commentary on plan drafts, collaboration with California universities, feedback from community-based and state-wide organizations, literature review of primary and secondary data to identify specific target populations, and input from other state exchanges,including Massachusetts, Colorado, Maryland, Washington, New York, and DC.10 Focus groups comprised of individuals representing the California population were established to further explore and identify the needs of the future consumer base and determine potential avenues of engagement.11 These focus groups were originally based largely on the major ethnic groups in California, with further segmentation based on factors such as language, willingness to participate in public programs, gender, age, and current insurance status.12 Creating a Brand Developing a comprehensive understanding of the values, perceptions, and needs within the target segments was only the first step towards creating a successful brand. The Exchange also needed a title that would resonate with the population it served and stand apart from other offerings as a trusted, accountable entity dedicated to assisting eligible populations in finding appropriate insurance coverage. The Exchange board developed a list of thirteen potential names for the Exchange – including media darlings such as “Avocado,” “Healthifornia,” and “Condor” (all of which were eliminated early on). The “final four” were selected from the initial pool of names based on input gathered from a series of focus groups

Fall 2012 Volume 13, Issue 2

STUDENT CONTRIBUTIONS that explored the meaning of the suggested names among various population segments – 1) Covered, CA/California, 2) CaliHealth, 3) Eureka, and 4) Ursa. 13 Due to concerns over the ability of the Exchange to trademark “CaliHealth” and the complexities arising from translating “Ursa” into a relevant name among the diverse language communities of California, the choices were narrowed down even further – 1) Covered CA, 2) Covered California and 3) Eureka remained and were sent into another round of extensive focus group testing with accompanying logos and taglines developed by Ogilvy.14 Both quantitative and qualitative data were gathered from focus group sessions comprised of 228 individuals ranging from ages 20 through 64, who were either Spanish-speaking only or English-speaking, though many of the English-speakers were bilingual in another language (Spanish, Tagalog, French, Vietnamese, Hebrew, Sign Language, Hindi, Italian, Chinese, German, or Hmong).15 Though Eureka was viewed more favorably with a logo than as stand-alone name, Covered California was overwhelmingly preferred among the focus group participants. Participants identified with the “double C” logo developed by Ogilvy, which forms a protective rainbow-shaped dome over four small people-shaped pegs inside. This image was especially meaningful to focus group participants who identified themselves as part of a family.16 After the completion of a legal review to approve the logo and tagline, the official brand name of California’s Health Exchange, “Covered California” (tagline: Your destination for affordable health care) was introduced to the public on November 1, 2012 and finalized during the subsequent Health Benefit Exchange board meeting thirteen days later.17 The Future of Covered California “Covered California” must now embark on a comprehensive marketing campaign in order to successfully reach the estimated 2.8 million Californians projected to utilize the Exchange in its initial year prior to the opening of the enrollment period in October of 2013.18 While many reports have focused on the nuances of designing the Exchange, many of have only briefly touched upon the significance of selecting an appropriate brand to attract consumers. “Covered California” is essentially a pilot program. While the Health Benefit Exchange board has engaged in extensive stakeholder outreach and invested a significant amount of money into designing a resource that will do what it was meant to do, the ultimate test of consumer acceptance remains to be seen. The name could become one associated with a trusted and reliable brand or, conversely, a public program that failed. Regardless of the outcome, California has operated on the idea that the Exchange should be a shared endeavor – for the

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people, by the people. Through fostering a sense of ownership with the communities that make up the diverse populations within the state, “Covered California” hopes to enter the marketplace in 2014 as a reflection of the needs and desires of the communities it serves.

wide Marketing, Outreach & Education Program: Final Phase I and II Work Plan, June 26, 2012, p.6. Accessed November 20, 2012, http://www.healthexchange.ca.gov/ StakeHolders/Documents/CHBE,DHCS,MRMIB_ ComprehensiveMarketingandOutreachWorkPlan_6-26-12.pdf

References 1. Pear, Robert. “U.S. Extends Deadline for States on Health Insurance Exchanges,” New York Times, November 15, 2012. Accessed November 19, 2012, http://www. nytimes.com/2012/11/16/us/states-deadline-extended-forinsurance-exchanges.html?_r=0 2. “Establishing Health Insurance Exchanges: An Overview of State Efforts,” Kaiser Family Foundation, August 2012. Accessed November 15, 2012, http://www.kff.org/ healthreform/upload/8213-2.pdf 3. “Affordable Insurance Exchanges,” The Center for Consumer Information & Insurance Oversight. Accessed November 14, 2013, http://cciio.cms.gov/programs/ exchanges/index.html 4. “Establishing Health Insurance Exchanges: An Overview of State Efforts,” Kaiser Family Foundation, August 2012. Accessed November 15, 2012, http://www.kff.org/ healthreform/upload/8213-2.pdf 5. California State Assembly Bill 1602, Statutes of 2010, Chapter 655, http://www.leginfo.ca.gov/pub/09-10/bill/ asm/ab_1601-1650/ab_1602_bill_20100930_chaptered. pdf 6. California State Senate Bill 900, Statute of 2010, Chapter 659, http://www.leginfo.ca.gov/pub/09-10/bill/sen/ sb_0851-0900/sb_900_bill_20100930_chaptered.pdf 7. Bartolone, P. “Branding the Health Insurance Exchanges to Make the Sale,” NPR, September 25, 2012. Accessed November 12, 2012, http://www.npr.org/blogs/ health/2012/09/25/161759253/what-s-in-a-name-california-brands-its-health-care-exchange. 8. Sanders, J. “Ogilvy named tentative winner of health exchange PR contract,” Sacramento Bee, March 1, 2012. Accessed November 17, 2012, http://blogs.sacbee.com/ capitolalertlatest/2012/03/ogilvy-public-relations-namedtentative-winner-california-health-exchange-contract. html#storylink=misearch 9. California Health Benefit Exchange. California Statewide Marketing, Outreach & Education Program: Final Phase I and II Work Plan, June 26, 2012, p.2. Accessed November 14, 2012, http://www.healthexchange.ca.gov/ StakeHolders/Documents/CHBE,DHCS,MRMIB_ 10. Ibid. 11. Ibid., p. 24. 12. Ibid. 13. Gorn, D. “The Exchange by Any Other Name,” California Healthline, September 19. 2012. Accessed November 20, 2012, http://www.californiahealthline.org/ capitol-desk/2012/9/exchange-narrows-name-list-to-four. aspx 14. Kelly, C. “Exchange Name and Brand Update and Recommendation - California Health Benefit Exchange Board Meeting [ppt],” California Health Benefit Exchange, October 30, 2012. Accessed November 3, 2012, http://www.healthexchange.ca.gov/BoardMeetings/ Documents/VI_HBEX-Presentation_ExchangeNameandBrand_103012.pdf 15. Ibid. 16. Ibid. 17. Gorn, D. “Exchange Picks New Name – Covered California,” California Healthline, November 1, 2012. Accessed November 21, 2012, http://www.californiahealthline.org/capitol-desk/2012/11/new-name-forexchange-covered-california.aspx 18. California Health Benefit Exchange. California State-

Erynne Jones is currently completing her MPH in Health Policy at UCLA’s Fielding School of Public Health. She completed her summer fieldwork through the California Medicaid Research Institute at the California Department of Health Care Services, where she participated in branding and outreach work with the California Health Benefit Exchange.

STUDENT CONTRIBUTIONS Eliminating Tax Exemptions on EmployerSponsored Health Insurance >>> Emily Shearer, AB Candidate Today, the majority of Americans receive health insurance tax-free through their employers. This tax-exemption represents a federal social tax expenditure that distorts market operations by encouraging high medical spending and upwardly distributing health benefits. Elimination of the health insurance tax exemption would reduce inequality between high- and low-income earners, slow growth of medical expenditures, and generate billions of dollars more in revenue annually. These savings should be used to finance subsidized coverage to low-income families on insurance exchanges as outlined by the PPACA.

he development of employer-sponsored health insurance is an accident of US history. In 1942, the federal government issued national wartime wage controls that necessitated competition among companies for scarce workers on the basis of pay. Employers were allowed, however, to offer health benefits to their workers as exceptions to these controls.1 The result was the explosion of employer-sponsored health coverage. In 1954, the phenomenon was cemented by the Internal Revenue Service’s change to the federal tax code that declared that contributions employers made to their employees’ health insurance plans could not be included in those workers’ taxable incomes.2 Today, over 158 million Americans benefit from this loophole by receiving tax-free health benefits through their employers.3 In 2011, employer-provided insurance was the leading source of coverage, representing 58.3% of all health plans.4

Analysis Social tax expenditures such as the health insurance benefit are forms of government spending that are carried out through the tax code. These policies do not operate through laissez-faire economics , but rather government subsidization of the private sector.5 Because such programs promote specific private activities and benefits through the use of tax credits, deductions, or exemptions, social tax expenditures distort market operations . In the case of health insurance, tax-exemption gives employers and employees a financial incentive to provide part of the worker’s compensation in the form of health benefits.6 By incorporating a health plan into a worker’s payment contract, the worker receives tax-free coverage. By contrast, workers who do not receive employer-sponsored insurance pay for their health benefits in after-tax income dollars, essentially receiving “less bang for their buck.” In turn, employers who offer coverage are able to enhance the value of their workers’ positions more efficiently than via wage increases. The incentive

is greatest for high-income employees, as they are in the highest tax brackets and therefore stand to capture the most benefit from increased coverage. The result is an insurance subsidy that is upwardly redistributive: 30% of benefits of employerprovided coverage are conveyed to the top 15% of the income distribution.7 The net worth of the subsidies are also skewed to the wealthy: the average household with an annual income of $200,000$500,000 received $4,971 in benefits, compared to $1,535 for one earning $10,000-$20,000.8 Moreover, the insurance tax subsidy has contributed to growing health care costs. Because employees who receive health insurance benefits from their employers do not face the full cost of the services they use, they have incentive to accept procedures and treatments offered even if the value added is small. Combined with perverse incentives on the part of physicians, who are largely compensated through fee-for-service mechanisms, and the explosion of new medical technologies in recent years, this has resulted in a dramatic increase in expensive medical services used per visit. Consequently, the US spends a greater percentage of its GDP on health with each passing year. This phenomenon is clearly illustrated by the, US’ medical expenditure growth rate, whichs hasve consistently outpaced GDP growth by several percentage points for the past decade. 9 Finally, tax-exemption on employer provided insurance is outrageously costly to the federal government. Reports from the Congressional Budget Office show that including health benefits in taxable income could translate to $246 billion in additional tax revenue annually.10 Future Steps The recent administration’s health care reform should be taken one step further. The Patient Protection and Affordable Care Act expands the health benefits social tax expenditure by mandating large employers to provide health insurance to their employees. While other aspects

of the PPACA, such as the new tax credit available to small employers offering health coverage , seek to address the inequality of the tax-exemption, they do not address the root of the problem. Rather than eliminating the perverse incentives of tax-exempt health insurance at larger companies, this policy merely extends them to smaller firms. Additionally, though the new “Cadillac Tax” that taxes health plans costing more than $27,000 in premiums per year seeks to eliminate these incentives for the most costly plans, it does not impact the vast majority of plans nation-wide, which fall below that high threshold. Addition of legislation eliminating the tax-exempt status of employer-provided health insurance should be considered as a way to build upon and improve existing health care reform. In this system, premiums bought by employers on behalf of their workers would be subject to a tax rate set by the federal government. This policy would save allow the US government annually, eliminate unfair subsidies to high-income citizens, and reduce market distortions that result in an artificially inflated demand for expensive medical services and escalate health expenditures. Moreover, increased revenue realized from this policy could be used to finance the federal subsidized to lowincome families on insurance exchanges as outlined by the PPACA . The US government should act to encourage competition among health plans on the basis of broad access to services, high quality of care, and competitive premium costs. This will not happen until employees, especially those in the top income brackets, are faced with higher out-ofpocket costs for expensive health plans. Please see p. 38 for references

Emily Shearer is currently a junior at Cornell University where she is double-majoring in Biology and Government with a minor in Health Policy. After graduation, she hopes to obtain a dual MD-MPP degree and pursue a career of both clinical practice and health policy work.

Fall 2012 Volume 13, Number 2

STUDENT CONTRIBUTIONS Affects of the Affordable Care Act on Safety-Net Providers: Intangible Obstacles for Health Care Access >>> Partow Zomorrodian, MA Candidate The Affordable Care Act (ACA) is a health care law that aims to improve the United States’ current health care system. The passage of the ACA will result in an additional 32 million people gaining health insurance and will cause significant changes to the delivery of health care.1 Safety-Net Providers (SNPs) are among the most important deliverers of health care to low-income, vulnerable, and uninsured populations.2 Academics, health care providers, legislators, and others have posed the following question, “How will the full implementation of the ACA and its provisions affect SNPs and health care access?” This article aims to answer this very question.

emote Area Medical (RAM) is a nonprofit, volunteer medical relief corp that provides free health, dental, and eye care.3 Stan Brock founded RAM in 1985 and its work was originally implemented in third world countries.3 Since the current health care delivery system does not provide adequate care to over 50 million1 americans, RAM performs 60% of its work in the United States.3 For those who are uninsured, programs like RAM function similarly to a safety-net provider (SNP). SNPs are institutions such as federally qualified health centers, community health clinics, free clinics, and rural health clinics. These institutions provide health care access to low-income, vulnerable population and undocumented immigrants who otherwise would not be able to afford care and offer access to services to patients regardless of their ability to pay. SNPs are important because they historically provide health care to uninsured populations from underserved areas.2 SNPs have additionally been known to ‘create places of care that maintain access for entire families, regardless of the family’s type of insurance or their ability to pay.’4 For example, Community Health Centers (a type of SNP) are ‘dedicated to the delivery of primary medical, dental, behavioral, and social services to medically underserved populations in medically underserved areas.’4 Whilst the ACA greatly expands access for millions, an estimated 23 million individuals will still remain uninsured.5 Of those who remain uninsured, many will be undocumented immigrants, who mostly receive their health care from ‘safety net providers…such as community health clinics.’6 Hence, the ability of SNPs to bridge this gap is very significant when one considers that the ACA does not allow for the coverage of undocumented immigrant.

Overall The passage of the Affordable Care Act (ACA) will increase challenges SNPs already face in the health care industry. The ACA and its provisions will have a serious effect on programs like RAM. This piece will highlight two provisions of the ACA that will significantly affect programs like RAM, henceforth referred to as SNPs. First, although the ACA increases access to healthcare and delivery systems, it does not address personnel and staff limitations in these systems. Second, while it increases the need for SNPs the ACA threatens crucial sources of funding for these programs. One of the most prominent provisions of the ACA is that it increase access to healthcare for millinons of uninsured Americans by expanding Medicaid to all non-Medicaid eligible individuals under the age of 65 with incomes up to 133% of the federal poverty level.6 An additional 17 million people will gain Medicaid and Children’s Health Insurance Program coverage (CHIP), which provides health coverage to children in families with incomes too high to qualify for Medicaid, but who can not afford private coverage.6 Along with this provision, the establishment of the exchanges (the state-regulated and standardized health care plans) will reduce the number of uninsured by approximately 32 million.1 These two provisions increase access to care for millions of uninsured individuals. The ACA also attempts to address the issue of limited facilities and personnel for services. Due to this influx of newly insured people, the workforce will be seriously strained. Derkson and Whelan comment that the number of primary care clinicians will continue to decrease while goals to implement universal coverage will increase the demand for physicians by 25 percent.4 In fact,

researchers estimate that by 2025 the U.S. will need around 65,000 additional primary care physicians in order to meet the anticipated health care needs.5 Additionally, the U.S. Bureau of Health Professionals estimates that the shortage of nurses will be over 400,000.4 Additionally, the execution of the ACA will result in a newly insured population who will experience obstacles in attaining care. These obstacles include: provider shortages, transportation issues, language and cultural barriers, and other impediments.6 For these reasons, the passage of the ACA will actually increase the need for programs like RAM and other SNPs. In a report by the North Carolina Institute of Medicine, it was expressed that SNPs are designed to “fill gaps” in the healthcare system and that their presence will still be integral after the complete implementation of health reform.6 Finally, even those who are insured may still find that they do not have affordable access and will consequently use SNPs. These are the very gaps that SNPs attempt to “fill”. Mark Hall argues that market conditions will continue to produce high levels of patientcost sharing in the form of deductibles and copayments.4 Although the ACA finances cost sharing for those 250% below the federal poverty level these individuals may still face unspeakable levels of expense, relative to their income.4 Lastly, Hall suggests that the need for SNPs will vary considerably from state to state. Variation will also occur within different parts of each state according to demographic and economic conditions.4 Without SNP support the ACA will not be able to achieve its goal of universal coverage. In some communities then, SNPs will be complementary to the efforts of the ACA. The SNPs will help achieve universal coverage by focusing on enrolling new eligibles and by providing access to those who will still remain uninsured.5 It is clear that the ACA will not ameliorate the need for programs such as RAM, but will instead require their assistance in providing care. The passage of the ACA not only increases the need of SNPs, but also simultaneously threatens the availability of sufficient and sustainable funding for them.5 Although some SNPs receive donations many rely on government funding and thus, a continuing point of concern is that their funding sources may be eliminated. The ACA will reduce the amount of Medicaid money set aside to help SNPs provide uncompensated care for patients with no insurance by at least half.11 Additionally, SNPs that are already exhausted by the disproportionate share hospital adjustment payment (DSH) reductions (payments provided to hospitals that serve a considerably disproportionate number of low-income patients) may lose additional funds under this program. This will leave SNPs without resources necessary to improve quality of care and patient experiences.11

Fall 2012 Volume 13, Issue 2

STUDENT CONTRIBUTIONS Many SNPs heavily rely on Medicaid reimbursements through what is known as valuebased purchasing (VBP). VBP is a type of payment reform under which hospitals and other providers are given bonuses based on their performances against different quality measures. Since ‘Medicaid is the single largest revenue source’5 for SNPs, these cuts pose serious threats. In fact, VBP could worsen the disparities between prosperous non-SNPs and struggling SNPs.11 SNPs in urban settings, who care for low-income patients, are an example of those struggling financially before the passage of the ACA. A study by the National Association of Urban Hospitals consolidates this, estimating that in 2014 the ‘federal government’s outlay for Medicare DSH is expected to decline by more than $9 billion… resulting in the average private-urban SNP to lose more than $8 million in DSH revenues.’12 Since Medicare’s new VBPs does not include risk adjustments for the challenges that patients and urban SNPs usually face, these policies place urban SNPs at a considerable disadvantage.12 To conclude, these losses in revenue will ultimately affect services, accessibility, and staffing at these SNPs. This study reaffirms that entire communities could feel very tangible losses if Medicare payments to hospitals are inadequate and if hospitals struggle financially. Since Medicare DSH, Medicaid DSH, and VBP cuts specifically target private urban SNPs, urban communities will most certainly be affected.12 Regulatory burdens on SNPs will also increase with the implementation of the ACA. Under the ACA, SNPs must take on new responsibilities and risks. For instance, the ACA requires that in order for non-profit hospitals to be tax-exempt they must fulfill certain requirements. These requirements include performing community health needs assessments every three years, making them publicly available, and bettering their care and performance by using the assessment results.5 SNPs are concerned over whether the resources of data collection will be available to them. Due to their typical lower-income and vulnerable populations, SNPs are highly likely to readmitt patients. Because of this SNPs may not meet assessment goals and may face payment reductions and financial penalities. Aside from assessment goals, there are other requirements in effect under the ACA that will predispose SNPs to financial penalities. This predisposment is a result of the population that SNPs typically deal with: the underinsured and underserved (such as the homeless and chronically mentally ill).4 Other instituions serving similar populations as SNPs will also experience higher readmission rates.4 SNPs (and other similarily suited insittutions) are already faced with significant financial burdens and the provisions of the ACA will likely result in them becoming unfairly penalized for their higher readmission rates. It is clear that the ACA paradoxically increases the need for programs like RAM whilst threatening their very existence. Although the ACA addresses the issues of implementing fairer local and national

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health policies, it does not fully address the problems associated with maintaining facilities and personnel for the supply of services. While the ACA insure more individuals it does not ensure sufficient access to care and an adequate supply of services. As perviously noted, the ACA’s new provisions may unfairly penalize SNPs since the provisions do not sufficiently take into consideration the patient population of these institutions. SNPs have significant hurdles to face in the new era of health care reform and the provisions of the ACA ultimately place SNPS under great financial burden while simlutaneously creating a dependency for them. Due to SNPs historically unique role their stability and funding must be seriously considered in order to maintain a sustainable health care market. Without such considerations the ACA may fall short of its goal of achieving comprehensive health care access for all Americans.

10. North Carolina Institute of Medicine, “Chapter 4: Safety Net.” Last modified 2008. Accessed October 3, 2012. http://www.nciom.org/wp-content/ uploads/2012/05/Ch.4-Safety-Net.pdf. 2012). 11. Lauer, George. California Healthline, “Safety-Net Hospitals Face Funding Cuts on Two Federal Fronts.” Last modified 2012. Accessed October 6, 2012. http://www. californiahealthline.org/features/2012/safetynet-hospitalsface-funding-cuts-on-two-federal-fronts.aspx. 12. The National Association of Urban Hospitals, . “The Potential Impact of the Affordable Care Act on Urban Safety Net Hospitals.” September , 2012. http:// www.nauh.org/component/option,com_rubberdoc/ format,raw/id,115/view,doc/ (accessed October 5, 2012). Image Source: The New York Times, 2012

References: 1. Kaiser Family Foundation, Last modified 2012. Accessed October 6, 2012. http://healthreform.kff.org/ the-basics/access-to-coverage-flowchart.aspx. 2. Adashi, Eli, Jack Geiger, & Michael Fine. “Health Care Reform and Primary Care — The Growing Importance of the Community Health Center.” The New England Journal of Medicine. no. 362 (2010): 2047-2050. http:// www.nejm.org/doi/full/10.1056/NEJMp1003729 (accessed October 5, 2012). 3. Sewanee University, . “Volunteers Needed for Remote Area Medical Clinic.” Last modified 2012. Accessed October 5, 2012. http://life.sewanee.edu/serve/remotearea-medical-clinic. 4. Hall, Mark. “The Mission of Safety Net Organizations Following National Insurance Reform.” Medicine, 26(7), 802-805. doi: 10.1007/s11606-011-1654-4. 26. no. 7 (2011): 802-805. 10.1007/s11606-011-1654-4 (accessed October 5, 2012). 5. Academy Health, . “The impact of the affordable care act on the safety net.” Last modified 2011. Accessed October 9, 2012. http://www.academyhealth.org/files/ FileDownloads/AHPolicybrief_Safetynet.pdf. 6. Minero, Gibran. “Healthcare Reform and Undocumented Immigrants.” Last modified 2011. Accessed October 3, 2012. http://improvehealthcare.org/ wp-content/uploads/2011/08/Gibran-UndocumentedImmigrants.pdf. 7. Kaiser Family Foundation, . “Who Benefits from the ACA Medicaid Expansion?.” Last modified 2012. Accessed October 2, 2012. http://www.kff.org/medicaid/ quicktake_aca_medicaid.cfm. 8. Derksen, Daniel & Ellen Whelan. Center for American Progress, “Closing the Healthcare Workforce Gap.” Last modified 2009. Accessed October 3, 2012. http://www.njhealthjobs.org/sites/default/files/health_ care_workforce.pdf. 9. Sataline, Suzanne, and Shirley Wang. “Medical Schools Can’t Keep Up.” Wall Street Journal, April 12, 2010. online.wsj.com/article/SB100014240527023045069045 75180331528424238.html (accessed Oct 10, 2012).

Partow Zomorrodian holds a Bachelor of Arts degree in Public Health and a minor in Public Policy from The University of California, Berkeley. She is currently a Masters in Public Health Candidate, in the Department of Health Policy and Management, at The University of California, Los Angeles Fielding School of Public Health. References for “Eliminating Tax-Exemptions on Employee-Sponsored Healthcare,” p. 39 1. Nicholson, Sean. “US Health Care System.” Lecture from Cornell University, Ithaca, NY, August 24-October 30, 2011. 2. Chen, Rachel. “Employer-Sponsored Health Insurance.” Yale Journal of Law and Medicine 4 (2009). Accessed September 19, 2012, http://www.yalemedlaw. com/2009/11/employer-sponsored-health-insurance/ 3. Chen, “Health Insurance.” 4. Nicholson, “Health Care.” 5. Mettler, Suzanne The Submerged State. Chicago: The University of Chicago Press, 2011, p. 18. 6. Nicholson, “Health Care.” 7. Mettler, Submerged, 23. 8. Mettler, Submerged, 24-25. 9. Nicholson, “Health Care.” 10. Chen, “Health Insurance.”

STUDENT CONTRIBUTIONS Valuing Patient Satisfaction: A New Paradigm in Medicare Hospital Reimbursement Policy >>> Thomas J. Hwang, AB Candidate

atient-centered care is a core pillar of the Patient Protection and Affordable Care Act (ACA), but the value of patient satisfaction remains controversial.1 In a seminal 2001 report, the Institute of Medicine defined patient-centeredness as “care that is respectful of and responsive to individual patient preferences, needs, and values.”2 Since then, the construct of ‘patient satisfaction,’ as a putative measure of patient-centeredness, has gained popular salience,3 industry acceptance,4 and political momentum. Proponents argue that patient satisfaction has “inherent value,”6 correlates well with outcomes,5 and is a “critical step toward understanding and improving the quality of care.”6-7 Detractors take issue with the equation of satisfaction and patient-centeredness.8-9 Still others question the purported association of higher satisfaction and better outcomes.10-11 The ACA directed the Centers for Medicare and Medicaid Services (CMS) to implement changes to its payment policies to move from a fee-for service model to a “quality”- or value-based system; and in a historic move for CMS reimbursement policy, the Act explicitly named patient experience as one of four quality domains by which hospitals would be evaluated.12 In subsequent rulemaking by CMS, patient satisfaction scores account for up to 30% of the total quality score for a hospital. Since the reimbursement policies of CMS shape markets and impact the behavior of providers across the country, changes of this nature and magnitude have both immediate and long-term effects. As CMS interprets and codifies the ACA’s statutory provisions through rulemaking, it is hoped that the overall system can improve outcomes and control costs by bridging the chasm between patient desires and their medical needs. We will consider several issues with the current quality scores weighting system that may warrant CMS review as the Agency implements

the Hospital Value-Based Purchasing (VBP) program. Statutory Basis The ACA contains a mix of positive and negative incentives to drive the move towards a pay-for-performance framework. § 3001, 3008, and 3025 of the ACA direct CMS, respectively, to reward hospitals for performance on certain quality measures (in the value-based purchasing program or VBP), penalize hospitals with the highest rates of hospital acquired conditions (HAC), and further reduce payment rates for hospitals with excess patient readmissions.13 Starting on October 1, 2012, hospitals began receiving incentive payments for providing high quality care under the VBP program. Participating hospitals are scored for each domain of quality measures, and the weighted domain scores are added to yield the Total Performance Score (TPS).14 CMS will fund these incentive payments through the withholding of funds: the per-discharge reduction in reimbursements is set at 1% in Fiscal Year (FY) 2013 and will increase to 2% by FY 2017.15 Hospital performance on patient satisfaction measures will comprise 30% of its TPS in 2013 and 2014 (Table 1). Meanwhile, the weight for process measures will drop dramatically from 70% to 20% by 2015. To determine the patient experience score, CMS will judge hospitals’ performance on the 27-question Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS), a standardized survey instrument developed by the Agency for Healthcare Research and Quality (AHRQ) and a partnership of public and private organizations.17 The HCAHPS survey questions range from the technical, such as behaviors directly observed by the patient, to more subjective ratings of care and hospital amenities. The survey itself is not new to hospitals: it was developed in 2002,

opened to public comment three times, and subsequently obtained endorsement by the National Quality Forum and approval by the Office of Management and Budget (OMB) in 2005.18 The survey was launched in 2006, with the first public reporting of results in 2008.19 While the survey itself may be well-established, its place in Medicare reimbursement policy is far more nebulous. Previously, both the HCAHPS survey and public reporting were voluntary opt-in.20 Potential Distributional Effects of Patient Satisfaction When developing the HCAHPS survey, AHRQ rigorously tested the instrument and included three questions on case-mix and two questions on race and ethnicity to allow the Agency to adjust for the heterogeneity in hospital patients across the country. Despite these adjustments, there is increasing evidence that suggests patient satisfaction scores vary by geographic region and provider type. Safety net hospitals (SNH), for instance, appear to perform poorly on patient satisfaction measures. SNH’s are notable in the broader context of health reform in that they care for a disproportionate number of ‘high-need, lowresource’ patients, namely Medicaid beneficiaries and the uninsured.21 At the same time, SNH’s rely disproportionately on public funding to sustain their care of vulnerable populations. SNH’s reliance on Medicaid and disproportionate share hospital (DSH) payments means that they are more sensitive to changes in payment policy than some of their peers.21 High performance on quality measures, with the implementation of VBP and other pay-for-performance programs, is necessarily critical for their survival.23-24 A national study of patient satisfaction in SNH’s found that SNH’s had lower performance than non-SNH’s on nearly all measures of patient experience used by CMS.25 While SNH’s were able to improve performance from 2007 through 2010, their rate of progress was lower than that of non-SNH’s, meaning the gap between the two types of hospitals increased over the period. Since many operate under tight financial margins, SNH’s may be disproportionately penalized by patient satisfaction measures in the VBP program. While every patient, regardless of status, deserves the highest quality care and the best possible patient experience, a program that disproportionately penalizes institutions serving a

Table 1. TPS Domain Weighting in Hospital VBP Program16

FY 2013 FY 2014 FY 2015 Domain Weight Domain Weight Domain Weight Clinical Process 70 Clinical Process 45 Clinical Process 20 Outcome 25 Outcome 30 Efficiency 30 Patient Experience 30 Patient Experience 30 Patient Experience 20

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STUDENT CONTRIBUTIONS

Figure 2. Hospital quality programs and at-risk Medicare inpatient payments31

disproportionate number of poor patients seems antithetical to the goals of the ACA. Supporters of quality programs contend that all hospitals should strive to a higher ideal. That poorer hospitals sometimes also have poor outcomes is certainly unjust. On the other hand, as some have previously argued, 26 financially constrained hospitals may not even have the chance to improve before being forced out of the market by the first years of penalties and withheld funds. In a March 2011 comment on the proposed Inpatient Prospective Patient System (IPPS) rule, the National Association of Urban Hospitals (NAUH) concurred stating that “giving such weight” to the HCAHPS survey would be “especially unfair to urban safety-net hospitals, which should not be penalized because they serve communities that are so culturally diverse.” As analysts have pointed out, one potential drawback of VBP provisions is the paradoxical “promotion of health disparities due to unachievable quality targets.”27 Moreover, evidence from Massachusetts shows that demand for care at safety-net facilities increased rather than decreased after comprehensive health reform in the state.28 Rather than being providers of last resort, it appears that SNH’s may actually be preferred providers of care for safety-net patients—further underlining their importance. Given current domain weighting, the use of patient satisfaction as a payment metric could potentially redistribute transfers. While systematic data on hospitals’ quality expenditures are limited, several hospitals have acknowledged that the costs of patient satisfaction interventions are not immaterial. Grady Health System in Atlanta is spending an estimated $4 million on upgrades to raise its survey scores.29 The Florida Hospital for Children spent nearly $200,000 on consulting fees alone to The Walt Disney Co. to improve its scores among children and their parents.30 On the other hand, interventions to improve performance on certain components of the HCAHPS survey complement, not detract from, efforts for patient-centered and outcomesmaximizing care. Better communication of

medications, for instance, can improve patient adherence to treatment, reducing the probability of drug-related readmissions or even serious adverse events.32 Nonetheless, in the context of this balancing act of hospitals and their bottom lines, there is reason to believe that shifting resources to raising patient satisfaction may come at the expense of the perhaps more difficult and costly incremental improvement in outcome measures. Recommendations Under the ACA, CMS has for the first time included an explicit measure of patients’ voices in provider reimbursement policies. Patient satisfaction measures are intended to nudge hospitals to pay greater attention to patients’ needs and their experiences in settings of healthcare delivery. Through incentive payments, penalties, and public reporting, it is hoped that the system will reduce costs, improve outcomes, and engender a more ‘patient-centered’ culture. These goals are laudable. CMS has thus far defended the domain weighting and the emphasis placed on patient satisfaction and experience. In the hospital VBP final rule, CMS responded to criticism of the weighting scheme, stating the current domain weights would “improve the link between Medicare payments to hospitals and patient outcomes, efficiency and cost, and the patient experience.”33-34 Yet, a preliminary snapshot of the changes in the industry suggests that there may be unintended consequences that may sever the “link between Medicare payments” and “outcomes.” Ironically, an over-emphasis on certain measures of the patient’s experience may, in fact, hinder the delivery of high-quality, patient-centered care. One proposal CMS could consider to minimize the unintended consequences on hospitals’ behavior and to allow CMS to monitor whether the policy is improving outcomes is the reduction of at least the initial domain weighting of patient experience in FY 2013 Medicare rates to 10% (range: 5%-15%). By instituting a gradual phase-in of the patient satisfaction domain, CMS would be better positioned to implement evidence-based policy. If the incentivizing of pa-

tient satisfaction demonstrates better outcomes, CMS would then have a credible case to increase the domain weights. Meanwhile, if data reveal negative outcomes due to the domain weighting, CMS should phase out the domain altogether. For a policy that can be as disruptive to the market as Medicare reimbursement, a “show benefit” rather than a “show no harm” approach may be more prudent and equitable. Moreover, a more modest starting domain weight has historical precedent and industry support. In a parallel process, private insurers, like Wellpoint, are incorporating patient satisfaction measures into their own payment programs, starting with a domain weight of 10%.35 Not surprisingly, hospitals strongly support lower initial patient satisfaction domain weighting. In an August 2011 letter to CMS, the American Hospital Association (AHA), which represents over 5,000 hospitals and health systems, proposed a 15% domain weight.36 The AHA wrote that this lower weight would “strike a balance between the importance of including a measure of patient experience in the VBP program and the concerns [it has] about potential biases present in the [HCAHPS] survey.”37 Reducing the initial domain weight may, in turn, alleviate the initial burden for safety-net and non-profit hospitals, as they seek to simultaneously improve their patient satisfaction scores and health outcomes. Further research on and surveillance of the size and nature of the distributional effects of its VBP policies is imperative, particularly as they relate to hospitals serving vulnerable populations and those that are the primary source of medical care in a given region. Transparent and frank debate on the calculus of domain weighting should also be encouraged. Thus, a gradual phase-in process, with a lower starting base rate, may help minimize potential deleterious effects and ensure the alignment of patient satisfaction scores with patient-centered care

Fall 2012 Volume 13, Number 2

STUDENT CONTRIBUTIONS and health outcomes. As implementation of the ACA marches forward, CMS should continue to balance the necessity of patient satisfaction with the other elements of VBP, including quality outcomes and affordability. Regulatory flexibility and data monitoring data could help CMS meet that mission.

References 1. Brown T. “Hospitals aren’t hotels.” The New York Times, published 14 March 2012; Letters to the Editor. “Using patient surveys to rate hospitals.” The New York Times, published 22 March 2012 2. Institute of Medicine, Committee on Quality of Health Care in America. Crossing the quality chasm: A new health system for the 21st century. National Academy Press (Washington D.C.), 2001. 3. Truog RD. Patients and doctors: Evolution of a relationship. N Engl J Med 2012;366(7):581-5. 4. In a letter to the Office of Management and Budget (OMB), the American Hospital Association wrote that “HCAHPS would enable [hospitals] to provide valuable information to the communities they serve.” See American Hospital Association. Letter to Office of Management and Budget in re. Hospital Consumer Assessment of Healthcare Providers and Systems survey instrument. AHA Press Release 2005. 5. Jha AK, Orav EJ, Zheng J, Epstein AM. Patients’ perception of hospital care in the United States. N Engl J Med 2008;359(18):1921-31. 6. Browne K, Roseman D, Shaller D, EdgmanLevitan S. Measuring patient experience as a strategy for improving primary care: Analysis and commentary. Health Aff 2010;29(5):921-5. 7. Luxford K. What does the patient know about quality? Int J Qual Health Care 2012;24(5):43940. 8. Kupfer JM, Bond EU. Patient satisfaction and patient-centered care: Necessary but not equal. JAMA 2012;308(2):139-40. 9. Elijovich F. Of sommeliers and wine drinkers. Arch Intern Med 2012;172(14):1111-2. 10. Fenton JJ, Jerant AF, Bertakis KD, Franks P. The cost of satisfaction: a national study of patient satisfaction, health care utilization, expenditures, and mortality. Arch Intern Med 2012;172(5):40511. 11. Chang JT, Hays RD, Shekelle PG, et al. Patients’ global ratings of their health care are not associated with the technical quality of their care. Ann Intern Med 2006;144(9):665-672. 12. Patient Protection and Affordable Care Act of 2010, Pub. L. 111-148, 124 Stat 119 through 124 Stat 1025, §3001(a)(2). 13. Id., at §3001, §3008, §3025. 14. Centers for Medicare and Medicaid Services (CMS). Hospital value-based purchasing (VBP) program: Calculating performance scores. CMS 2012.

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15. CMS. Hospital value-based purchasing (VBP) program: Translating scores into payments. CMS 2012. 16. CMS. Final rule: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long- Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals’ Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers. 42 CFR Parts 412, 413, 424, and 476. Federal Register Vol 170, No 170:53258-53750; published 31 August 2012. 17. The HCAHPS survey is administered to a random sample of patients, between 48 hours and six weeks after discharge, continuously throughout the year, and scores are reported on the Hospital Compare site each quarter. See Agency for Healthcare Research and Quality (AHRQ). HCAHPS Fact Sheet (CAHPS® Hospital Survey). AHRQ 2009. 18. See supra note 17. 19. Id. 20. The Deficit Reduction Act authorized CMS to withhold 2% of payments to Inpatient Prospective Patient System (IPPS) hospitals that fail to report a basket of quality measures, including the HCAHPS survey. See Deficit Reduction Act of 2005, Pub.L. 109-171, §5001. 21. Institute of Medicine. America’s health care safety net: Intact but endangered. Marion Lewin and Stuart Altman (eds.). National Academy Press (Washington D.C.), 2000. 22. Bachrach D, Braslow L, Karl A. Toward a high performance health care system for vulnerable populations: Funding for safety-net hospitals. Commonwealth Fund 2012. 23. Jha AK, Orav EJ, Epstein AM. The effect of financial incentives on hospitals that serve poor patients. Ann Intern Med 2010;153(5):299-306. 24. Katz MH. Safety-net providers and preparation for health reform: staff down, staff up, staff differently. Arch Intern Med 2011;171(15):1319-1320. 25. Chatterjee P, Joynt KE, Orav EJ, Jha AK. Patient experience in safety-net hospitals: Implications for improving care and value-based purchasing. Arch Intern Med 2012;172(16):120410. 26. Goldman LE, Henderson S, Dohan DP, Talavera JA, Dudley RA. Public reporting and pay-for-performance: safety-net hospital executives’ concerns and policy suggestions. Inquiry 2007;44(2):137-145 27. Deloitte Center for Health Solutions. Valuebased purchasing: A strategic overview for health care industry stakeholders. Deloitte CHS 2011. 28. Ku L, Jones E, Shin P, Byrne FR, Long SK. Safety-net providers after health care reform: lessons from Massachusetts. Arch Intern Med 2011;171(15):1379-84. 29. Adamy J. U.S. ties hospital payments to making patients happy. The Wall Street Journal, published 14 October 2012.

30. Gluck F. Hospitals turn to Disney for patientsatisfaction advice. USA Today, published 22 September 2011. 31. CMS, supra note 18; UBS. Hospital management: ‘I’m still standing after all this time.’ UBS Global Equity Research 2012. 32. Zolnierek KB, Dimatteo MR. Physician communication and patient adherence to treatment: A meta-analysis. Med Care 2009;47(8):826-834. 33. See supra note 16. 34. CMS. Final rule: Hospital Inpatient ValueBased Purchasing Program. 42 CFR Parts 422 and 480. Federal Register Vol 76, No 88:26490-26547; published 6 May 2011. 35. Adamy J. WellPoint shakes up hospital payments. The Wall Street Journal, published 16 May 2011. 36. American Hospital Association letter to CMS in re. CMS-3239-P, Medicare Program; Hospital Inpatient Value-Based Purchasing Program; Proposed Rule [Vol. 76, No. 9] (2011).

Originally from New York City, Thomas Hwang is a junior at Harvard in Adams House. He is pursuing a Special Concentration in Biomedical Innovation and Health Policy. Previously, he worked at the White House (on health reform and regulatory policy), World Health Organization, and the private sector.

Health Highlights The Imperative, and Opportunity, of Chronic Disease >>> Elizabeth Teisberg, Ph.D, Scott Wallace, J.D., M.B.A. Redefining care for chronic diseases is necessary to achieve better health outcomes without ever-rising costs. Chronic disease drives 75% of health care spending, yet health care delivery is primarily designed around acute care. Effective, successful care for chronic conditions requires care that helps people change lifestyle. Those kinds of integrated, multidisciplinary services are rarely available now. Achieving better health outcomes for more people at lower costs requires a different approach to the rapidly rising tide of chronic conditions.

edefining care for chronic diseases is necessary to achieve better health outcomes without ever-rising costs. Public health’s goal of primary prevention, preventing disease onset, is failing. More than half of all Americans presently have at least one chronic medical condition and in 18 states, diabetes incidence climbed more than 100% between 1995 and 2010. Record levels of obesity and challenges of lifestyle change suggest that the incidence and severity of diseases will worsen. Attention now needs to focus on secondary prevention, slowing or stopping the progression of disease in those who are afflicted. Health care delivery is likewise failing at effectively treating chronic conditions. Although they drive more than 75% of all health care spending, convenient and effective care for chronic conditions remains the exception.1 While most hospitals offer surgery for amputating gangrenous toes and replumbing plaque-clogged arteries, very few have demonstrably effective

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programs to stop chronic diseases from progressing. Chronic disease care needs redefinition. With the coming bulge of health reform’s newly-insured patients, health care needs a new direction. The consequences of ineffective secondary prevention are that chronic disease care happens too late and is too expensive. Massachusetts went down this path when its expanded coverage triggered a surge in people seeking care. Done correctly, this surge in patients seeking earlier stage care can be an enormous opportunity to improve health. Success will require that people can access convenient and effective care for their chronic conditions. Lifestyle, Not Behavior. Redefining chronic disease care requires addressing the realities of these diseases. While widely described as lifestyle driven, many caregivers believe chronic diseases result from weakness and inappropriate behavior. However, lifestyle is more complex than a behavior. The implications of lifestyle explain why non-

infectioushealthconditionslikeobesityandsmoking are nonetheless communicable. People who smoke are far more likely to live in families of smokers, and those who are obese are more likely to have family and friends of similar weight. Not surprisingly, smoking cessation programs that include whole families or worksites are more effective than those targeting individual, unconnected smokers. People share lifestyles. Successful lifestyle change requires new models of care that equip people to make the array of changes required by their condition. The Cleveland Clinic’s Lifestyle 180 program is on the right track.2 That program combines traditional medical care with exercise and yoga, relaxation and stress management training, and classes that teach people new ways to think about nutrition, cooking and even eating. After a cooking class in which participants prepare a meal using thickeners instead of fats, and spices and citrus instead of salt, they eat together observing a healthier, slower pace of eating. Health Care to Change Lifestyle. Changing lifestyle requires a tremendous effort by a patient and a family. If health care is going to play a role in helping people change lifestyles, it must offer an array of new and different services that recognize and address the social dimensions and other challenges of lifestyle change. Simply providing more information or more energetically wagging fingers won’t help. Chronic conditions require health care in concert with medical care. For these services, a more efficient team involves much more than using a nurse practitioner rather than a physician. The care team will need members with expertise in nutrition, cooking, activity and stress reduction – areas in which physicians and nurses are not trained. The traditional care model, built around a one-to-one relationship between a physician and a patient, isn’t effective at changing lifestyle. While physician/patient relationships will always be important, traditional care models are wildly inconvenient for most patients. Most chronic diseases cut across multiple organ systems forcing patients to navigate a baffling array of appointments to treat what, for them, is a single medical condition. For patients with chronic conditions that require a lifetime of care, that inefficiency is a tremendous burden. Without a single destination for care, patients are forced to navigate a complex array of health services, designing a package of care services to meet their needs and mediating, often on their own, the conflicting advice they are given. Soaring health care costs, together with the inconvenience and waste, show that this system is not efficient. Frustration, complexity and poor results have led to a call for navigators. Health plans and providers are starting to offer the promise of a navigator to help every patient. That approach seems to accept fractured care delivery and confusing health insurance as essential and unfixable. Instead of more navigators, patients need a simpler structure. Patients and families need convenient access to expert care that is organized around their health needs rather than around medical specialties or facilities.

Health Highlights The idea is not one-stop-shopping for colocated but still fractured services; patients need integrated services from a team that shares a panel of similar patients. St. Francis Hospital, a Bon Secours hospital in Greenville, South Carolina is piloting a different approach that integrates services for patients with Type 2 diabetes.3 Patients participate in experience groups, exercise classes, cooking and shopping lessons…. The support for lifestyle change improves results. In the first year, patients lost an average of 20 pounds, many reduced the number of medications they needed and some reversed the diagnosis of diabetes altogether. Ironically, the most significant challenge to this kind of care innovation is not patient adherence, clinical team participation or payment. Patients volunteered for the new style of care. And while it the style won’t work for every person, it is important to note that it works unusually well for some families. Given the opportunity, nurses and physicians worked enthusiastically with patients and employers to design the needed services. Local employers were willing to pay for the additional services to have healthy employees with fewer lost work days. The biggest challenge was for the health plan that administers claims because different care requires different claims processing. Surely that administrative challenge can be solved to achieve better health. Redefine Primary Care for Chronic Conditions. The structure of traditional primary care almost guarantees a lack of expertise in effectively treating most chronic disease. Today’s structure demands too much of primary care physicians and nurses. In the name of access, primary care physicians and nurses are expected to treat an almost unlimited range of illnesses and conditions. They do so with long hours of work and impressive compassion, but the requirements of the job limit the depth of expertise and compromise the effectiveness of care. No one can be expert in the staggering array of chronic conditions that present in primary care offices. But in the face of the impending chronic disease tsunami, some primary care services need redefinition around patients supported by expert teams. The challenge of successfully managing chronic disease is made more difficult by the fact that for most people, the diagnosis of a chronic disease is their first introduction to that medical condition. It doesn’t help if the primary care provider also sees these problems infrequently. Part of the benefit of a practiced multidisciplinary team of care providers is that they offer insight on making the experience easier and the success greater. Fewer things have to be discovered anew by the patient and family. The traditional model of care is inefficient as well as ineffective. It relies too heavily on expensive physicians. As a result, many primary care practices are unequipped to provide the range of lifestylerelated services that patients with chronic condi-

tions need. Simply keeping the existing care model and replacing expensive physicians with relatively less expensive nurses and nurse practitioners isn’t enough of an answer. Instead, care must be restructured so that the needs of patients are addressed by caregivers who can most efficiently and effectively offer care. The needed services can be delivered more efficiently, and more effectively, by health coaches, diabetes educators and others who are not typically part of a traditional primary care practice. The West German Headache Center achieves dramatic pain reduction and impressive migraine prevention for its patients with a weeklong, full day outpatient clinic.4 Patients attend a series of classes or appointments each day, only one of which is with a physician. Other professionals lead sessions on exercise, stress management, diet, sleep and physical therapy. Physicians, who are under-qualified for these dimensions of treatment, could not lead most of those sessions better. In addition to bringing an array of differently trained caregivers onto the team, effective chronic disease care integrates these efforts rather than leaving them loosely coordinated or uncoordinated. The Western Diabetes Center acted on research indicating that periodontal disease is rampant among people with diabetes, and untreated, periodontal disease can accelerate heart disease and strain patients’ immune systems . To address that need of its patients, the center integrates dental care into its routine care program that already includes endocrinology, cardiology and podiatry. Measures of periodontal disease are included in health outcome measures that Western tracks. Change the Trends of Chronic Disease. Success in secondary prevention – slowing, sometimes stopping the progression of chronic disease – is possible. This could be done on a national scale. But success requires that chronic disease care be redefined so that it dramatically improves health outcomes. Innovation in care delivery for chronic disease will change the course of health care and health care spending. Of course, it won’t stop chronic disease or leave hospitals empty. But a dramatic improvement in care services for chronic disease could reduce the rate of growth of demand for acute care, making the challenges of health care for all more manageable The goal of health care is better health. With the growing burden of chronic conditions, better health requires more convenient, effective and efficient solutions for patients and families. Redefining chronic disease care is an extraordinary challenge. It is also an powerful opportunity to improve health outcomes in ways that reduce costs. References 1. “Chronic Diseases.” Centers for Disease Control and Prevention. http://www.cdc.gov/chronicdisease/resources/publications/aag/chronic.htm

(accessed January, 2013) 2. “Lifestyle Medicine.” Cleveland Clinic. http:// my.clevelandclinic.org/wellness/reclaim_your_ health.aspx (accessed January, 2013) 3. “Diabetes Center.” St. Francis Hospital. http:// www.stfrancisheartcenter.com/patients/deptsand services/diabetescenter.html (accessed January, 2013) 4. Porter, Michael, Gluth, Clemens, and Dannemiller, Elisa. The West German Headache Center: Integrated Migraine Care. Case study. Boston: Harvard Business Publishing, 2008

Elizabeth Teisberg is Professor of Community and Family Medicine at the Dartmouth Center for Health Care Delivery Science and the Geisel School of Medicine at Dartmouth. She is co-author, with Michael E. Porter, of Redefining Health Care.

Scott Wallace is a Visiting Professor of Community and Family Medicine at the Geisel School of Medicine at Dartmouth. He was appointed by President Bush as Chairman of the Federal Commission on Systemic Interoperability, and was the founding CEO of the National Alliance for Health Information Technology.

Fall 2012 Volume 13, Number 2

Health Highlights The Free Clinic: An essential source of care for the uninsured despite passage of the ACA >>> Frederick M. Barken, MD

acking access to any form of sustained, comprehensive primary health care, the sick and injured, the downtrodden and disenfranchised, wait patiently at the free clinic, seeking relief from their most intolerable symptoms and pressing medical needs. This clinic, however, is not run by Médicin Sans Frontières, Doctors Without Borders, in some politically tense, bulletridden corner of the globe. Nor is it a makeshift relief tent amid the abject poverty and unsanitary state of earthquake-devastated Haiti. It is the Ithaca Free Clinic, a charitable source of outpatient medical care, located in upstate New York providing approximately 3,000 patient visits per year to the uninsured in a town of 30,000. Home to two major academic institutions, Ithaca is blessed with a remarkably high educational mean, a prosperous rate of growth, and relatively low unemployment in the era of The Great Recession. Yet, for some Ithacans, sadly, the fundamental human right to basic medical care1 remains illusory and out of reach.1 Their lack of access to proper primary health care befits a third-world nation, hardly a positive example of American exceptionalism. Medically, it seems, a rising tide does not lift all boats. Weathered, chronically exhausted, and prematurely aged, the low-wage worker strings together two or three part-time jobs, yet falls short of garnering a true living wage. Earning a bit too much to qualify for public assistance and Medicaid, he or she lives paycheck to paycheck, perhaps sleeps on a friend’s sofa, but enjoys no other cushion in what has become a hard life in modern times. The nouveau poor are not all burger flippers, shovel-ready laborers, or menials. They include the outsourced line worker, the under-employed academic and the older part-time worker, not quite yet a Medicare beneficiary. The downsized and downwardly mobile, those squeezed from the middle, suffer what Barbara Ehrenreich,2 in Nickel and Dimed, refers to as a “repetitive injury of the spirit.”2 In health, as in all spheres, the poor do poorly3; the new working poor are no exception.3 Dental care is often the first casualty, with cracked, carious, or abscessed teeth a frequent incidental finding on examination at the Ithaca Free Clinic. A young man, a Master’s degree holder, complains

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of bilateral heel pain where the soles of his shoes have worn through to skin. Astronomical blood pressures and poorly controlled blood sugars are the norm among walk-in patients lacking prescription coverage or the $4 cash for “cheap” generic pills. Hypertension, diabetes, and elevated cholesterol, the modern maladies of man, go undiagnosed among the uninsured and, if diagnosed, undertreated.4 Absence of health insurance is associated with an overall increased mortality.5 Intuitively, this makes sense, yet

the causal mechanism remains obscure. Late presentation in the course of an illness, misuse of emergency services, and the absence of the salutary benefits of a sustained physician-patient relationship with a primary care provider6 are oft-cited explanations.6 What is clear is that the true “donut hole” of American health care is that remaining group of citizens which is forced to go bare of insurance and is exposed to the elements of disease and dysfunction, on their own. For the foreseeable future, therefore, free clinics across the country will remain a de facto critical component of US health care and a crucial safety net for those who walk a tightrope, at any moment a step away from serious medical illness. Historically, charity medical care was the moral fulfillment of a physician’s professional Hippocratic oath. A doctor expected, in certain cases, to adjust fees by sliding scale, to write off bad debt, or simply to provide services gratis. He or she might spend an afternoon at an almshouseassociated clinic or make ward rounds with interns at an overcrowded municipal hospital. Charitable treatment was rendered to the “deserving” poor: the abandoned wife, widow, or orphan, in a facility

primarily intended to provide salvation rather than solutions. Unwed mothers, alcoholics, and syphilitics, the pariahs of the past, were not so fortunate to find compassionate care. In the mid-1960s, President Lyndon Johnson’s War on Poverty fundamentally altered charity care. The passage of Medicaid, took a very private matter, a charitable gift from a doctor to a patient in dire straits, and institutionalized it. Centralized top-down administration, delayed and insultingly meager physician reimbursement, and endless red tape snuffed out any feel-good factor of charity care, paradoxically reducing physicians’ inclination to volunteerism. Yet, for all its problems, Medicaid, to some extent, improved the health of millions at the lowest of socioeconomic levels, by making sustained primary care available to those recipients lucky enough to find a participating doctor.7 American health care coverage today is a crazy patchwork quilt of programs and policies: Medicaid as a floor for the very poor, Medicare for our seniors, and private insurance for the well compensated and fortunate. With President Obama’s re-election, voters reaffirmed by ballot the decision of Supreme Court Chief Justice, John Roberts, regarding the Patient Protection and Affordable Care Act (PPACA). Yet, even after 2014, as PPACA ratchets up, the working poor still will slip through the cracks. The employer mandate will apply only to firms hiring at least 50 workers. Remarkably, some 19 million nonelderly adults, those stringing together two or more low-pay jobs yet earning less than a true living wage, will be the last Americans to go without access to care.8 The “health care have-nots” have few options. The Emergency Medical Treatment and Labor Act (EMTALA) secures emergency medical evaluation, but sustained, relational, and compassionate primary care, the true backbone of US health care, remains out of reach. Pro bono physician care, practical in the era of the solo private practice, is anathema to the large corporate medical mega-practices that now subsume the independent practitioners. Free clinics across the country must and will continue to be a source of charitable care for the working poor. We should not delude ourselves; free clinics cannot match the services rendered through a sustained physician-patient relationship with a primary care provider. A two-day health fair or large temporary clinic held in a stadium or amphitheater provides only brief access with no scheduled followup. This works well enough for extraction of a bad tooth, a one-time blood pressure screen, or for a long-overdue Pap smear. But it is not primary care. Furthermore, the paucity of imaging studies and proper laboratory diagnostics, and the lack of access to specialty referral, make the free clinic less than an

Health Highlights equivalent to comprehensive, coordinated, and compassionate care for all. Yet, we all are lucky that they are there. Today we sail into the turbulence caused by enormous disparities of income and wealth.9 The economics of unequal opportunity disrupt society, cause grave dysfunction, and are disastrous for our health as a nation. On the upper deck, the well to do seek so-called concierge care, true personal, relational primary care for a contracted price, paid gladly. Concierge care, however, is merely a market solution and an unintended consequence of long-time piecemeal health care legislation. It recognizes a market niche, a void to be filled, and a need unmet. But down below, in steerage, are those who must continue to do without access to care. At some point we all must come to appreciate that access to health care is a universal, societal imperative. Your health matters to me, and vice versa. Like literacy, it is a common good. Until we come to terms with that fact, we all sail on the Titanic. The devastation wrought by hurricane Sandy, one in a now regularly recurring series of natural calamities, is a sobering reminder of our fragility. Yet, the storm clouds have one silver lining: the rapid response of charity and volunteerism at the local level. Sudden disasters garner strong, synchronous relief and community support. Medical care for the uninsured, in good weather or foul, is a moral imperative as great as hurricane relief. We must once again inculcate volunteerism as part of medical training, expected of all practitioners, and a gift given in return for the privilege of practice. Free clinics must have a reliable source of financial support, whether through local, state, or federal funding, or by stable charitable donations to a “dot.org.” Free clinics are a player in America’s health care delivery system; they need to be recognized and funded as such. Throughout the rancorous debate on health care in this country, too little has been said about the preservation of human dignity.10 To be seriously sick is a lonely and terrifying experience, made worse by the indignity suffered as a shut out. Free clinics strive to restore that dignity. However, no amount of charitable care can hope to achieve parity among patients short of universal health care coverage, firmly establishing health care access as a fundamental human right. But the PPACA, soon to achieve coverage of some 32-million previously uninsured individuals, cannot mandate an appointment with a doctor. There are far too few practicing primary care providers to meet the challenge. Ancillary services such as dental, vision, mental health, wellness education, and complementary forms of care will remain out of reach for millions of Americans, and cultural and logistical barriers to care of the underserved will persist. Poverty and the social determinants of ill health are likely to remain unresolved. The Ithaca Free Clinic and its counterparts across the country,

therefore, will continue to offer an essential service as a vital component of US health care delivery.

References 1. United Nations Universal Declaration of Human Rights, Article 25(1), December, 1948. 2. B. Ehrenreich, Nickel and Dimed (New York, NY: Picador, 2001). 3. M. Marmot and R. Wilkinson, Social Determinants of Health (Oxford, UK: Oxford Press, 2006). 4. A.P. Wilper, S. Woolhandler, K.E. Lasser, D. McCormick, D.H. Bor, & D.U. Himmelstein, “Hypertension, Diabetes, and Elevated Cholesterol Among Insured and Uninsured US Adults,” Health Affairs 28(2009)(2009); 28(6):w11511159. 5. A.P. Wilper, S. Woolhandler, K.E. Lasser, D. McCormick, D.H. Bor, & D.U. Himmelstein, “Health Insurance and Mortality in US Adults,” Am J of Public Health (2009); 99(2009)(12):1-7. 6. F. Barken, Out of Practice: Fighting for Primary Care Medicine in America (Ithaca, NY: Cornell University Press, 2011). 7. J. Engel, Poor People’s Medicine: Medicaid and American Charity Care since 1965 (Durham, NC: Duke University Press, 2006). 8. M. Buettgens and M. Hall, Who Will Be Uninsured After Health Insurance Reform? (Robert Wood Johnson Foundation, March, 2011). 9. R. Wilkinson and K. Pickett, The Spirit Level: Why Greater Equality Makes Societies Stronger (New York, NY: Bloomsbury Press, 2009). 10. B. Hoffman, Health Care for Some: Rights and Rationing in the United States since 1930 (Chicago, IL: University of Chicago Press, 2012).

Dr. Frederick Barken practiced general Internal Medicine in upstate New York for 23 years. He left clinical practice in 2007 to write Out of Practice: Fighting for Primary Care Medicine in America, an analysis of the challenges now facing primary care practitioners and a plea for the preservation of the physician-patient relationship. He lectures at Ithaca College on topics in health care policy. Recently he returned to clinical medicine as a physician volunteer at the Ithaca Free Clinic.

Fall 2012 Volume 13, Number 2

Health Highlights Breast Density Notification Laws and the Patient’s Right to Know >>> Handel Reynolds, MD FACR

n September 2012, California joined Connecticut, Texas, Virginia and New York in enacting legislation requiring mammography facilities to notify women of their breast density status. Breast density and its significance in mammography are subjects with which radiologists have been quite familiar for decades. Only recently, however, has this critical information begun to be shared with the general public. On a mammogram, breast tissue appears as a combination of white (dense) and dark gray (fatty) tissue. The relative proportions of these two tissue types varies from woman to woman and also changes over time. Some women have breasts that are primarily dense; others are primarily fatty. Furthermore, as women age, the proportion of dense tissue gradually decreases and fatty tissue eventually predominates. It is important to note that this is a distinction that can only be made with a mammogram. The texture of the breast to the touch is an unreliable predictor of a woman’s density status. Women who have mammographically

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dense breasts suffer two principal insults. First, they have an approximately three to five times higher risk of developing breast cancer than women with fatty breasts. 1 This is equivalent to a woman having one or two first-degree relatives with breast cancer. Second, these women are much more likely to have their cancer missed by mammography. On mammography, breast cancer generally appears as a white object because of the density or “hardness” of the tumor. In dense breasts, such white objects are much more difficult to perceive because they tend to blend into the background dense tissue. Finding a polar bear in a snowstorm is a commonly used analogy. As in the other four states, the new California law requires that women with dense breasts be informed of these twin hazards. They are also to be encouraged to have a conversation with their physician about possibly undergoing additional screening tests to supplement mammography. The most commonly employed supplemental screening tests are ultrasound and MRI. The Connecticut

law goes further than the others. In that state, insurance companies are required to cover the costs of the additional screening if the patient and her physician deem it necessary. The passage of the California law highlights the urgency that now surrounds this issue. Vetoed by Gov. Jerry Brown in late 2011, state legislators amended the bill’s wording to satisfy his concerns and speedily ushered the new version through the legislature, getting to signed law less than a year later. In fact, we are in the midst of a true grassroots movement that is notching significant victories in rapid succession. Four of the five state breast density laws were enacted between June 2011 and September 2012. According to Are You Dense Inc., an organization dedicated to nationalizing this density notification effort, similar legislation is currently pending in fifteen other states and at the federal level. 2 A woman’s right to know her breast density status has quickly become one of the most active fronts in the ongoing fight against breast cancer. Just over fifty percent of women undergoing screening mammography have dense breasts.3 Radiologists have known for decades that, among these women, mammography performs very poorly. Despite this, there has been, until recently, no consistent effort to educate the public on this issue. A 2010 Harris poll found that ninety-five percent of women over forty did not know their breast density status and ninety percent did not know that having dense breasts was a risk factor for breast cancer. 4 Nancy Capello, founder of Are You Dense Inc., came face to face with this issue in 2004 when, two months after receiving a letter informing her that her annual screening mammogram showed no evidence of cancer, she felt a lump and was diagnosed with advanced breast cancer. Only later did she learn that she had dense breasts and that this severely limited mammography’s effectiveness. It was through her efforts that Connecticut became the first state to pass a breast density notification law in 2009. She has famously dubbed the dense breast issue, mammography’s “best-kept secret.”5

Health Highlights Has the mammography community been “keeping secrets” from the American public? As painful as this allegation is, I do feel that it contains a kernel of truth. It has been true historically and it remains so today. For decades, mammography has been promoted using direct, unambiguous messages that can be summarized as a simple “just do it” admonition. In fact, message simplicity has always been the overriding consideration in mammography campaigns. Providing too much information has long been viewed as having the potential to “confuse” women and discourage them from being screened. Even today, as women all over the country demand access to their breast density information and as state legislatures pass laws to compel disclosure, the American College of Radiology continues to cling to these outdated, paternalistic notions in its effort to restrain this growing movement. In its official position on reporting breast density information directly to patients, the organization states, “...For women with dense breasts, receipt of breast density information may cause undue anxiety about their risk and worry that mammography may have missed a breast cancer.”6 Given the fact that the reliability of mammography in dense breasts is no better than a coin toss, these women have every right to worry. Historically, the primary goal of mammography campaigns has been to increase utilization rates and, in this regard, they have been very successful. The vast majority of age-appropriate women undergo mammography with some regularity. There has never been a commensurate effort to educate the public about mammography. For this reason, many women (a majority in a 2003 survey) harbor the misguided notion of mammography as breast cancer prevention, as opposed to early detection.7 Further, many are completely unaware of the test’s well-established limitations: false negatives (misses), false positives (false alarms leading to unnecessary additional testing) and overdiagnosis (finding cancers that otherwise would never have come to light in the individual’s lifetime). Had the pro-screening community expended even half as much effort on true public education as has been spent on promotion, American women would have acquired a much more complete and accurate understanding of the strengths and weaknesses of mammography. We would not find ourselves in the current

situation where, four decades after the start of widespread mammography screening in the United States, the public has suddenly awakened to one of mammography’s major limitations and is demanding government action. Public health policy should always err on the side of full disclosure. While simple, unambiguous messages may, in the short run, avoid confusing the public, it is an unsustainable strategy in the long run. Eventually, all secrets get out!

References 1. McCormack, Valerie A and Isabel dos Santos Silva. “Breast Density and Parenchymal Patterns as Markers of Breast Cancer Risk: A Meta-analysis.” Cancer Epidemiology Biomarkers and Prevention 15 (2006): 1159-69. 2. Are You Dense Advocacy. http:// areyoudenseadvocacy.org/dense/ accessed November 13, 2012. 3. Gierach, Gretchen L, Laura Ichikawa, Karla Kerlikowske, Louise A. Brinton, Ghada N. Farhat, Pamela M. Vacek, Donald L. Weaver, Catherine Schairer, Stephen H. Taplin and Mark E. Sherman. “Relationship Between Mammographic Density and Breast Cancer Death in the Breast Cancer Surveillance Consortium.” Journal of the National Cancer Institute 104 (2012): 1218-27. 4. Harris Interactive. http://www. harrisinteractive.com/vault/DensitySurvey-Release-final-5-19.pdf Accessed November 13, 2012. 5. Are You Dense? http://www. areyoudense.org/worxcms_published/ stories_page13.shtml Accessed November 13, 2012. 6. American College of Radiology. http:// www.acr.org/About-Us/Media-Center/ Position-Statements/Position-StatementsFolder/Statement-on-Reporting-BreastDensity-in-Mammography-Reports-andPatient-Summaries Accessed November 13, 2012. 7. Domenighetti, Gianfranco, Barbara D’Avanzo, Matthias Egger, Franco Berrino, Thomas Perneger, Paola Mosconi and Marcel Zwahlen. “Women’s Perception of the Benefits of Mammography Screening: Population-Based Survey in Four Countries.” International Journal of Epidemiology 32 (2003): 816-21.

Handel E. Reynolds, MD FACR is a Breast Radiologist at the Doris Shaheen Breast Health Center at Piedmont Hospital in Atlanta, GA. Prior to joining Piedmont Hospital, he spent more than a decade in academic practice at Indiana University School of Medicine where he held the titles of Associate Professor of Radiology and Chief of Breast Radiology. He is a Fellow of the American College of Radiology and a Fellow of the Society of Breast Imaging. He is the author of The Big Squeeze: A Social and Political History of the Controversial Mammogram (Cornell University Press, 2012).

Fall 2012 Volume 13, Number 2

Health Highlights Food Democracy on the March >>> Mark Winne, MA Citizen-led efforts, often in partnership with private organizations and public entities, are increasing their involvement in the development of local, state, and tribal food policies. Evidence shows that many of these policies are designed to increase access to healthy and affordable food, especially in lower income communities. Food policy councils and food planning are key drivers for these new policy initiatives. Between 2010 and 2012, the number of food policy councils has grown from 111 to 193. Major challenges to more substantial food policy reforms are coming from large food industry sectors. They will need to be addressed by ever growing citizen involvement at all levels of policy making. “…no famine has ever taken place in the history of the world in a functioning democracy.” - Amartya Sen or the longest time, I had assumed that the words of the Nobel Laureate economist Amartya Sen only applied to the developing world. It hadn’t occurred to me that they might be relevant to domestic U.S. food security and health policy as well. That changed one day during a monthly meeting of the City of Hartford Commission on Food Policy, when one of our members briefed us on the status of the city’s W.I.C. Program. Apparently, enrollment in the city-run Women, Infant, and Children Program, which provides select nutrition benefits to lowincome mothers and children, had dropped in one month from 10,000 participants to 6,000. The 15 commission members gathered around the table, including myself, were stunned. We all knew that Connecticut’s poorest city had not experienced a sudden outbreak of prosperity such that the need for nutritional assistance had significantly abated. We donned our sleuthing caps to find the cause.1 It didn’t take long before the culprit was discovered. An indifferent city bureaucracy had shuttered one of Hartford’s two W.I.C. clinics to undertake some minor renovations, which according to one building inspector were “likely to take several months.” In the meantime, both current and prospective “WIC moms” had no more information than a handwritten “Closed for Repair” sign taped to the clinic’s front door. Further investigation by the food commission uncovered a pattern of slovenly office management that left phones unanswered, rude staff behavior commonplace, and clinic hours that were the envy of bankers. In the face of these obstacles a large segment of the city’s most vulnerable population had simply given up. A quickly arranged meeting with Hartford’s mayor and health department ensued. We apprised them of the problems and offered our assistance,

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but made it abundantly clear that the situation was intolerable and that the media would be alerted if action wasn’t taken immediately. Lo and behold, the clinic re-opened in a week, the previous caseload was restored within a month, and members of the Commission would serve on a city task force to correct the office management issues. Amartya Sen’s learned observation that the needy will be nourished “when a government is accountable to the public, and when there is free news-reporting and uncensored public criticism” proved true even in the squirrely world of American urban politics. Local and State Food Policy Moves to Center Stage Shaping national food policy has been a rocky affair at best. Reliance on big national policy moments like the Farm Bill and the Child Nutrition Act has frustrated public health and food advocates for decades because of their perplexing inability to join health, environment, and agriculture goals. For those seeking faster and more nimble small “p” policy actions, local and state governments increasingly offer more attractive playing fields. It might be said that democracy, at least in the way that Amartya Sen envisions it, works best when the people and policy makers are in close proximity to one another. Food policy councils such as the one in Hartford (founded in 1993) are becoming key players in placing food and its attendant health concerns on the agendas of city halls and state legislatures. A food policy council consists of a designated set of individuals representing various sectors – government and non-government, food production to consumption – of a geographically and jurisdictionally defined area. A food policy council (sometimes called a “council,” “advisory council,” “commission,” or “food system network”) gathers and analyzes food system information, makes recommendations on program and policy issues, educates the public about needs, and fosters

coordination between various food system actors.2 The first local council was founded in Knoxville, Tennessee in 1982. The first state council was formed in Connecticut in 1998 when it was established by an act of the state legislature. Over the past ten years there has been acceleration in the development of food policy councils at the local, regional, and state/provincial/tribal levels. The Community Food Security Coalition conducted a census in 2012 that found 193 active councils compared to 111 in 2010. Almost 30 percent of the 2012 councils were state, provincial, or tribal while the rest were local (city, county, city/county, or regional).3 Closely associated with this growth is the phenomenon of local, state, and national food planning. Climate change and droughts, food price spikes, growing rates of obesity and diabetes, loss of farmland, limited access to healthy and affordable food, and food insecurity have spurred the creation of food plans, strategies, and charters. From Seoul, South Korea to London, England, from Australia to Canada, and from Seattle to New York City political leaders are not only recognizing the global reach of actual and potential food crises, they are responding to an engaged citizenry that wants action. Opinion polls conducted over the past few years suggest that the public’s interest in food and health is soaring. A 2012 poll commissioned by the W.K. Kellogg Foundation found that 93 per cent of people surveyed say it’s “very important or somewhat important that all Americans have equal access to fresh fruits and vegetables,” 75 per cent support a national program to double the value of SNAP benefits (the Supplemental Nutrition Assistance Program, formerly known as the Food Stamp Program)when used at farmers’ markets, and 68 per cent report eating more whole grains and fresh fruits and vegetables than five years ago.4 In response to concern over the rising rates of childhood obesity, a 2011 Pew Research Center poll found that 57 percent of those surveyed want the government to address that problem compared to a similar poll conducted five years ago that indicated only 40 percent were interested in public intervention.5 While a latent public antipathy may exist toward the so-called “nanny state” (e.g. negative reactions toward Mayor Michael Bloomberg’s recently passed soda size restrictions), an overarching “meta-mood” seems to support constructive interventions by government to promote healthy eating. Food charters like the one passed in Detroit three years ago articulate a set of principles and values that are designed to guide the city’s policy makers and NGOs. It prescribed the creation of the Detroit Food Policy Council which has used the charter to advocate for a more robust urban agriculture sector and improved access to healthy food outlets.

Health Highlights Several political leaders in New York City have developed food plans, the best known of which is “Food Works.” A product of collaboration between the Speaker of the City Council, Christine Quinn, and numerous private and public sector food experts, Food Works identified 59 goals for improvements in the city’s food system as well as the specific areas within city government that can assist with the implementation of those goals.6 While the growing ranks of outspoken “foodies” (5,000 people, for instance, attended a one day Brooklyn food forum in May 2012) will never be satisfied with the pace of government progress, to one like me, who has been a community food activist for 40 years, the spate of government health-related food initiatives is nothing short of breathtaking. Sometimes in concert with government and sometimes independently, food policy councils have asserted their will in ways both big and small to shore up the critical links between health, food production, the food economy, planning, and citizen participation. According to a 2012 survey conducted by Johns Hopkins School of Public Health, U.S. food policy councils are most likely to take on the following issues: access to food (providing affordable, nutritious food to school children and low-income populations), agriculture (promoting land preservation and urban agriculture), and procurement (seeking policies that direct public institutions to buy locally grown food).7 The same Hartford Food Policy Commission referenced above conducted an area-wide transportation study that found public transit did an inadequate job of connecting the city’s low-income consumers to supermarkets (by the mid-1990s, Hartford had been all but abandoned by supermarkets). By educating policy makers and working closely with regional transportation planners, the Commission was able to secure new bus routes that took the city’s poorest shoppers directly and quickly to high quality retail food outlets. In a similar vein, the Connecticut Food Policy Council recommended that the state’s economic development agency make a $1 million investment in a new supermarket project in a lowincome New Haven neighborhood, the first new supermarket in that community in 20 years.8 The New Mexico Food and Agriculture Policy Council, founded in 2003, established working partnerships with state agencies and legislative leaders to expand funding for farm-toschool initiatives and to halt the sale of sugary soft drinks in New Mexico’s public schools. More recently, the Council secured support for new public procurement regulations that would increase the purchases of New Mexico-grown food in public institutions.9 The Michigan Food Policy Council contributed to the development of a state food charter that links food purchases to the state’s

economic and human health. It is now working toward the following goals: Increase locallygrown food purchased by public institutions to 20 percent by 2020; ensure that 80 percent of Michigan’s residents have easy access to affordable, healthy, and fresh food; and incorporate food and agriculture into the state’s public education curriculum from K through 12.10

system stakeholders increasingly want, but we can expect to see these local food system struggles played out against the messy sausage-making of a “functioning democracy.” The more citizens who participate in the policy making process, however, the more likely that transparency will be achieved, that government will be held accountable, and that the public interest will be served.

Challenges Ahead The achievements of the ClevelandCuyahoga Food Policy Council exemplify both the opportunities and challenges that an engaged food citizenry face in promoting a healthier food environment. Starting in 2005, the Food Policy Council forged a close, working partnership with members of the Cleveland City Council as well as key city administrative staff to align efforts to improve both Cleveland’s economic and health problems. To achieve this goal they coordinated a number of city functions including zoning, procurement, and economic development to promote urban farming and gardening, better access to healthy food outlets, and the creation of local food enterprises.11 Building on this food focus, the Cleveland City Council and the Food Policy Council announced the “Healthy Cleveland Initiative,” which, among other components, included a ban on the use of trans-fats in restaurants and food shops. As one of the Initiative’s prime sponsors, City Councilman Joe Cimperman referred to the ban as one of “the more common-sense things we’re trying to do in terms of public health.” Catching wind of this new regulation, the state’s restaurant association promptly secured passage of a bill from the Republican-controlled Ohio legislature that pre-empted the authority of the state’s municipalities to make any law pertaining to food ingredients, an action that Cimperman fervently denounced as “pro-obesity, pro-diabetes, pro-death.”12 Cities and states are becoming more frequent battlegrounds in the growing food wars. While some are deploying incentive-based strategies that make it easier for SNAP participants to use their benefits at farmers’ markets, others are taking more aggressive approaches like banning trans-fats or restricting the size of sugary soft drinks. And some states have tried or have proposed disincentives such as special sales tax on soft drinks. In all cases, there is clearly a welling-up of citizen concern over the long term health, safety, and source of their food. Both elected and non-elected city officials are listening and acting, but as the stakes for those who are obligated to protect their corporate bottom lines increase, so does their pushback. Food policy councils and other citizen-driven and private-public food policy partnerships can gather the data, make the case, and advocate for change that food

References 1. Sen, Amartya. The idea of justice. Cambridge, Mass.: Belknap Press of Harvard University Press, 2009. 2. Winne, Mark. “Resource Materials.” Community Food Systems and Food Policy. http://www.markwinne. com/resource-materials/. 3. Sauer, Andrea. “FPC  List  Update Analysis.” North American Food Policy Council. foodsecurity.org/FPC/ doc/FPC_List_Update_Analysis-May2012.pdf. 4. “Food & Community.” W.K. Kellogg Foundation. http://www.foodandcommunity.org/conference. 5. “Most See Role for Government in Reducing Childhood Obesity | Pew Research Center for the People and the Press.” Pew Research Center. http://pewresearch. org/pubs/1916/obesity-children-government-role-poll. 6. “Food Works.” NYC City Council, council.nyc.gov/ downloads/pdf/foodworks1.pdf 7. “Exploring Food System Policy: A Survey of Food Policy Councils in the United States.” Journal of Agriculture, Food Systems, and Community Development. Volume 2, Issue 4. http://www. agdevjournal.com/volume-2-issue-4/277-survey-of-foodpolicy-councils-in-us.html?catid=111%3Aopen-callpapers 8. Winne, Mark. Closing the food gap: resetting the table in the land of plenty. Boston: Beacon Press, 2008. 9. “New Mexico Food and Agriculture Policy Council.” Farm to Table. http://www.farmtotablenm.org/policy. 10. “Charter Development and Summit.” Michigan Good Food. http://michiganfood.org/ 11. “Cleveland-Cuyahoga County Food Policy Coalition.” Home. www.cccfoodpolicy.org. 12. Cleveland Plain Dealer, June 08, 201l

Mark Winne has held leadership positions with several non-profit food organizations and food policy councils. He writes, consults, and speaks on food-related topics for Mark Winne Associates. His two books are “Closing the Food Gap” and “Food Rebels,” both published by Beacon Press. For more information, see www.markwinne.com.

Fall 2012 Volume 13, Number 2

Health Highlights Cost Savings in the Emergency Department: Look Beyond the Low Acuity Visits >>> Peter B. Smulowitz, MD, MPH, Bruce E. Landon, MD, MBA Our article describes a topic at the intersection of health care payment reform, cost containment, and emergency care. The financing of emergency care has not been prominent in the national discourse around health care reform, yet the emergency department (ED) is a major focus of attempts to reduce the cost of health care. In this paper we describe our novel framework for categorizing ED visits that gives a clear understanding of the types of ED visits that are most amenable to cost savings. Heretofore, a major focus has been on diverting low acuity visits. In the world of global payments, we show why the more practical step would be to focus on reducing hospital admissions via the ED. We then discuss the basic ways in which the ED will need to be better integrated into the wider health care system in order to meet the dual goals of cost control and the provision of quality care.

ost control is front and center in the U.S. health policy agenda. One frequently cited target for cost control is the emergency department (ED), but how much potential savings exists from ED care remains a key question. Both the medical and lay literatures have long highlighted the cost of emergency department visits and the potential for cost savings by diverting “non-emergency” ED visits to lower cost settings of care.1-3 Consequently, there is a long history of attempts to either prevent or divert low urgency ED visits, ranging from the relatively draconian (e.g., the state of Washington Medicaid program recently made an unsuccessful attempt to refuse payment for certain “medically unnecessary” ED visits) to simply raising copayments for use of the ED. These efforts, however, place the burden of preventing low acuity visits squarely on the shoulders of patients. Patients who use the ED, however, usually go there because they lack access to other providers or they perceive that that their medical problem is serious enough to warrant emergency care.4 Whereas diverting low acuity visits seems at first glance to be a path to significant savings, a closer inspection tells a different story. Recently, we categorized ED visits by their potential to realize cost savings for the health care system. Our simple framework divides ED visits into three categories:

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emergent, intermediate/complex, and minor injury/illness.5 For each category we identified the components of the visit that account for the visit’s marginal contribution to costs, particularly when compared to a similar visit in a primary care setting, and estimated the potential costs savings associated with modifying ED use in each category.5 We found minimal potential for savings in the category of true emergency visits. High acuity cases such as those that result from trauma or from acute medical (e.g., acute myocardial infarction) or surgical (e.g., acute appendicitis) cases clearly are appropriate for the ED. In addition, these cases are relatively under-reimbursed relative to their true cost, which includes both the costs directly associated with these visits as well as the costs of the fixed stand-by capacity of the ED related to staffing and equipping an emergency

department to deal with a broad range of these cases (e.g., availability of specialists, advanced imaging, etc.). Similarly, although low acuity visits are frequent, the actual savings that could be attained by diverting these visits is relatively small. This is in large part because the cost of these low acuity visits is relatively low. For instance diverting 100 pharyngitis (sore throat) visits would result in a savings of just ~$10,000.6 We estimate that diverting half of the low urgency ED visits would achieve a savings of only 0.2% to 0.8% of total health expenditures under optimal conditions.5 The true savings, however, are likely to be far lower because the real costs required to extend primary care office hours to nights and weekends, or to establish urgent care centers are likely to be substantially higher than the average reimbursement for such visits. Moreover, even a wildly successful program would end up diverting only a fraction of visits. Consequently, the greatest potential for savings lies in the remaining category of intermediate or complex cases, which includes acute exacerbations of chronic disease and acute presentations of complex medical illnesses. Although ED expenditures account for just 2-4% of total health expenditures, the ED serves as the gateway to almost 50% of hospital admissions and the downstream costs entailed therein.4 With an average cost of $10,400 to the Medicare program for an admission for congestive heart failure, for example, preventing a single admission could result in savings equivalent to diverting nearly 100 low acuity visits. Using conservative assumptions, we estimate that reducing hospitalizations in this category by 10-25% could result in a minimum potential savings of up to 2.5% of total health expenditures,5 which could total over $7 billion annually. To a lesser extent there also is potential for cost savings by streamlining extensive ED work ups for these complex cases. Recent work suggests that the ED is the source of a growing number of hospital admissions. From 1993 through 2006 the percentage of all admissions originating from the ED has increased from 33.5% to 43.8%, including 12 of the 13 most common conditions admitted to the hospital.7 It might appear, then, that reducing “avoidable” admissions is a ripe source for cost reduction. Preventing admissions, however, requires hard work and enhanced coordination between the ED and primary care and other care sites to carefully coordinate follow-up. Furthermore, apart from some readmissions,

Health Highlights there is a paucity of information as to what interventions might effectively and safely lead to reduced admissions from the ED. Nonetheless, investments in resources and systems to manage admissions from the Recent work suggests that the ED is the source of a growing number of hospital admissions. From 1993 through 2006 the percentage of all admissions originating from the ED has increased from 33.5% to 43.8%, including 12 of the 13 most common conditions admitted to the hospital.7 It might appear, then, that reducing “avoidable” admissions is a ripe source for cost reduction. Preventing admissions, however, requires hard work and enhanced coordination between the ED and primary care and other care sites to carefully coordinate follow-up. Furthermore, apart from some readmissions, there is a paucity of information as to what interventions might effectively and safely lead to reduced admissions from the ED. Nonetheless, investments in resources and systems to manage admissions from the ED has the largest potential to achieve measureable cost savings for the system overall. Thus, we contend that instead of focusing on the inexorably frustrating and so far largely unproductive area of diverting non-emergent ED visits, health system managers should look for ways to avoid hospitalizations and repeat ED visits for high-risk patients. This means expanding our thinking and better integrating the ED as a vital piece in the continuum of health care. Discussions about payment reform and the move towards building Accountable Care Organizations (ACOs) rarely mention the ED. Yet our framework demonstrates that interventions to reduce cost associated with ED care will be important as systems look towards reducing unnecessary expenditures. ACOs will find it both cost effective and better for overall quality to coordinate care for patients with conditions that are predisposed to ending up in an ED as well as to improve alternatives to admission for patients already in the ED, rather than by investing substantial resources into programs designed to divert low acuity care. This includes ensuring the availability of quality home health care, skilled nursing facilities, and urgent primary care or specialist follow-up. Inevitably, it also requires the capacity to use health information systems to improve care coordination between diverse sites in order to facilitate physicians’ ability to make more informed decisions about treatment and disposition. Finally, consideration of the financing of ED care in a health care system built upon

global payments deserves further scrutiny. Health systems will have to balance the seemingly contradictory notions of reducing ED expenditures while also maintaining universal availability and equitable distribution of emergency care. The ED carries certain unavoidable fixed costs. Yet, in today’s piecemeal payment system, nobody pays for the “stand-by” capacity of the ED, a public good akin to the fire department.8 Federal legislation recognizes the right to universal access to emergency care but has not provided a funding mechanism to support the EDs stand-by capacity, and currently additional facility fees and excess fees from low acuity visits are an important part of the formula for supporting this capacity. Thus, both policy-makers and health system administrators will need to be cognizant of the true costs of maintaining ED capacity and consider how efforts to impact ED utilization will impact the overall economic viability of the provision of emergency care. References: 1. Williams R. The costs of visits to emergency departments. N Engl J Med 1996;334:642-646. 2. Bamezai A, Melnick G, Nawathe A. The cost of an emergency department visit and its relationship to emergency department volume. Ann Emerg Med 2005;45(5):483-490. 3. Massachusetts Division of Health Care Finance and Policy. Preventable/Avoidable Emergency Department Use in Massachusetts: Fiscal Years 2004 to 2008. Boston, MA 2010. 4. Gindi RM, Cohen RA, and Kirzinger WK. Emergency room use among adults aged 18–64: Early release of estimates from the National Health Interview Survey, January–June 2011. In Early Release, National Center for Health Statistics, Editor 2012, National Center for Health Statistics. 5. Smulowitz PB, Honigman L, Landon BE. A Novel Approach to Identifying Targets for Cost Reduction in the Emergency Department. Ann Emerg Med 2012; (doi:10.1016/j. annemergmed.2006.09.019). 6. CY 2012 Physician Fee Schedule Final Rule With Comment Period. Available at: https:// http://www.cms.gov/PhysicianFeeSched/. Accessed November 11, 2012. 7. Schuur JD, Venkatesh AK. The growing role of emergency departments in hospital admissions. N Engl J Med. 2012;367(5):391393. 8. Duckett S, Jackson T. Paying for hospital emergency care under a single-payer system. Ann Emerg Med Apr 2001;37(3):309-317.

Peter Smulowitz, MD, MPH is an attending physician in the department of emergency medicine at Beth Israel Deaconess Medical Center and an Instructor in Medicine at Harvard Medical School. Dr. Smulowitz worked previously as a health care policy fellow for Senator Richard Moore in the Massachusetts Senate Committee on Health Care Finance. Dr. Smulowitz has published on the impact of Massachusetts’ 2006 health care reform on emergency department utilization and has a current interest in methods of cost control related to emergency care.

Bruce Landon, MD, MBA, MSc is a Professor of Medicine at Beth Israel Deaconess Medical Center and a Professor of Health Care Policy at Harvard Medical School. Dr. Landon’s primary research interest has been assessing the impact of different characteristics of physicians and health care organizations, ranging from health plans to physician group practices, on the provision of health care services.

Fall 2012 Volume 13, Number 2

Health Highlights Eating Disorders on College Campuses: Implications for Prevention and Treatment >>> Megan Jones, PsyD, Alison Darcy, PhD, Danielle Colborn, PhD, Maria Christina Stewart, PhD, & Kara Fitzpatrick, PhD Eating disorder (ED) symptoms are prevalent among college students and large numbers of students do not seek treatment. Colleges and universities can play a key role in preventing, identifying, and treating EDs given the multiple channels through which students can be reached, including health services, residential education, academic affairs, social networks, and extracurricular activities. A stepped-care service delivery model in which interventions are tailored to students’ ED risk or symptom severity is recommended as a model for management of EDs on college campuses. This paper provides a summary of the current status of EDs on college campuses, including identification, prevention, and evidence-based treatment.

ating disorder (ED) symptoms are prevalent among college students. Recent surveys estimate that 13.5% of women and 3.6% of men screen positive for EDs and 20% of college students report a history of an ED.1,2 Disordered eating behaviors and unhealthy weight regulation methods appear to have increased in this population over the last decade and affect an even greater number of students.3 Subclinical symptoms are associated with significant distress and impairment, and persist over time.1 Of great concern are the large numbers of students with EDs who do not seek treatment, an estimated 80 to 90% of individuals who screen positive for an ED.1, 4 College presents a unique opportunity to prevent, identify, and treat EDs given the multiple channels through which students can be reached, including health services, residential education, academic affairs, social networks, and extracurricular activities. This paper provides a summary of the current status of EDs on college campuses, including identification, prevention, and evidence-based treatment. We also highlight key challenges and important areas for further outreach and research. How do EDs in College Students Present? ED Screening Transitions are times when problem behaviors may become exacerbated. The transition to college is a major life event that occurs in the context of significant neurological change. For many students, college also marks a change in their eating environment, comparison of eating habits with peers, and possible concern about the “Freshmen

Harvard Health Policy Review

15” weight gain myth.5 It is unsurprising then, that the peak age of onset for BN, BED and EDNOS is 16-20 years, around the time that young people leave home and go to college.6 EDs are often associated with other problems such as major depression, panic disorder, generalized anxiety, suicidal ideation, self-injury, binge drinking, cigarette smoking, and marijuana use, making early detection and intervention among this population of even greater public health importance.1 Fortunately, there is a growing literature on ED screening instruments with good predictive validity that can identify ED risk factors, and preventive interventions to reduce ED risk and onset have been developed. Screening can be conducted on a mandatory basis for incoming students as part of entrance medical forms, “strongly encouraged” (i.e., recommended but not required) in the same way that many universities promote alcohol education programs for new students, or advertised as one of several resources available to students through health promotion and/or counseling center services.7-9 We favor an online format for screens as this permits greater anonymity and confidentiality, easier access, and the provision of immediate feedback to the student with recommendations for appropriate resources. Wide-spread screening also promotes a greater reach among the student body and reduces the potential to overlook problematic behaviors among students. Looking Beyond the Stereotype Campus professionals must be sensitive to signs of disordered eating and exercise behaviors among

students of all backgrounds, as we have significant evidence that EDs are not unique to Caucasian, upper-middle class, heterosexual, female students. Males Males are less likely than females to be treated for their ED despite similar clinical severity.10 Further, in clinical settings males have been shown less likely to be diagnosed with a clinical ED. It is now clear that the traditionally quoted female:male ratio of 9:1 is a gross underestimation and that there are more males with EDs than previously thought.1 In fact, these studies and health services research have revealed a large and worrying gap between the numbers of males with EDs in the college community and the much smaller number who present for treatment.11 Part of the problem is detection, and that commonly used measures were developed and normed for females.12 Males present with different body image concerns than the typical gendered ED presentation. For example, males may want to build muscle mass, or lean muscle mass, and thus employ muscle building strategies (over-use of protein supplements or use of anabolic steroids) at the same time as they employ weight loss strategies and/or engage in excessive exercise.13 Given the importance of early detection, it is essential that campus professionals be aware of both their own lowered index of suspicion and of the increased levels of shame that may surround males. Furthermore, it is important to keep in mind that many males may not be aware that they may have a problem. Special efforts can be made to tailor outreach efforts and interventions to be more engaging and relevant for males. LGBTQ Students Homosexuality is a specific risk factor for males with EDs.14 The largest case series of males with EDs reported a strong association between homosexuality or bisexuality and EDs, especially BN.15 The same association does not appear to exist for lesbian women, however. Rates of homosexuality/bisexuality among males range from 17% to 27%, compared to only 2% among females.15,16 The reasons for this association among males is unclear, though theories include that gay youth are exposed to increased stress involved with coming to terms with their sexuality in the context of increased social intolerance for both males and females. Two small case series also suggest that transgenderism (maleto-female and female-to-male) is also a specific risk factor for ED.17, 18 Overall, this suggests that LGBTQ organizations and social networks are hugely important for outreach initiatives and overall health promotion on college campuses.

Health Highlights LGBTQ Students Homosexuality is a specific risk factor for males with EDs.14 The largest case series of males with EDs reported a strong association between homosexuality or bisexuality and EDs, especially BN.15 The same association does not appear to exist for lesbian women, however. Rates of homosexuality/bisexuality among males range from 17% to 27%, compared to only 2% among females.15,16 The reasons for this association among males is unclear, though theories include that gay youth are exposed to increased stress involved with coming to terms with their sexuality in the context of increased social intolerance for both males and females. Two small case series also suggest that transgenderism (maleto-female and female-to-male) is also a specific risk factor for ED.17, 18 Overall, this suggests that LGBTQ organizations and social networks are hugely important for outreach initiatives and overall health promotion on college campuses. Ethnicity While the literature on college women is somewhat mixed, the majority of studies suggest that African American women are less likely than Caucasian, Latina, or Asian American women to have an ED, and that the prevalence among young Latina women appears to be increasing. The trend is different among males, with the most consistent findings from large population based studies of young American males demonstrating that non-Caucasian adolescent males (African American, Latino, Asian and Native American) are overrepresented in ED behaviors; as well as in full syndrome clinical presentations.19, 20, 21 Again, health promotion and outreach initiatives should be aware of these trends and plan services accordingly. Athletes Athletes can also present specific challenges to universities. The line between fitness for sports and poor-health can often be blurred, and many young female athletes, in particular, hold beliefs that are associated with malnourishment and can cause long-term harm (e.g., lack of menstruation). Colleges and universities who develop a comprehensive program to address nourishment and health among student athletes are at the forefront of student-based health initiatives. Such programs may include coach education and collaborations among mental health staff, physicians, nutritionists, trainers and coaches. Graduate Students Graduate and professional students are often

overlooked as part of the university population and in many cases have access to different types and levels of health-care. Graduate students often comprise a significant percentage of the cases of EDs seen at universities. Graduate students who present with symptoms of EDs may have more chronic and possibly more acute cases. As a result, graduate students may require special outreach and access to a higher level of service than their younger counterparts. It is therefore important that screening and outreach efforts target all students within a university community. Comorbid Problems Comorbidity in EDs is the norm rather than the exception, with problems such as depressive disorders, anxiety disorders, substance abuse and Axis II problems being most common. In addition, it appears that these problems may also be significant pathways to EDs among college populations with high weight and shape concern, increasing the risk of developing an ED from 4% among those without additional risk factors to 60% with additional factors (e.g., history of depressive disorder, panic disorder, binge drinking, or being teased by a coach or teacher).22 Given the high rate of these problems on college campuses, interventions that focus on associated factors such as drinking in moderation, effective coping, and affect regulation may also help in reducing development of EDs. Prevention Universal and Targeted Prevention The high prevalence of EDs and disordered eating behaviors and low rate of treatment-seeking among college students necessitate prevention and early identification of EDs. Researchers have investigated a variety of prevention strategies among college students and several evidencebased programs are now available.23, 24 The Body Project and Reflections Body Image Program are both in-person, peer-facilitated, dissonancebased, brief (< 4 sessions) universal prevention interventions that have been found to reduce thin-ideal internalization, improve body image, and reduce ED pathology.25-28 An alternative or counterpart to in-person prevention programs are online interventions. Online programs have several advantages, including anonymity, ease of dissemination, improved accessibility, and the ability to be instantly updated and tailored to student needs. The most widely studied online indicated prevention program (i.e., targeting high risk students), StudentBodies, is an 8-week Internetdelivered cognitive behavioral program that

targets women with high weight and shape concerns using a combination of structured content and an online asynchronous moderated discussion group. The program incorporates elements of interventions previously shown to be effective in reducing ED attitudes and behaviors in controlled studies, such as body image components, increasing tolerance to negative emotions, reducing perfectionism, negative selfevaluation, and interpersonal difficulties.29, 30 StudentBodies has been shown to be effective in numerous studies conducted in the United States and elsewhere in reducing weight and shape concern and preventing the onset and progression of EDs in high- risk groups.31 Indicated Prevention While gains have been made in preventing EDs in young women with high weight and shape concerns and very low levels of compensatory behaviors (e.g., Taylor et al., 2006), many women show more frequent and severe symptoms and behaviors that may progress to full-syndrome EDs.3 At highest risk for EDs are women with weight and shape concerns, a history of depression, and a history of receiving critical comments about eating, weight, and shape.32 There is a huge need to provide indicated prevention programs for college-age women with subclinical EDs. In a recent review, Yager and Oâ€™Dea note that as many as 60% of female students have subclinical ED symptoms and more than 10% have clinical EDs.33 Therefore, university counseling services are not likely to have sufficient resources to deal with this problem; referral of all individuals with subclinical and clinical EDs would overwhelm counseling resources, and specialized evidencebased services often are not available to all students who require this level of care.34 Stepped Care An alternative to referral for face-to-face treatment is to provide a stepped care model in which students in need of indicated prevention (defined as having subclinical symptoms) undergo guided self-help, and those who do not improve or worsen are referred to clinical services. Interventions for subclinical EDs have been developed and demonstrate good promise as a component of a stepped-care model, though additional research in this area is needed.35 A stepped care model allows for the provision of a full-spectrum of services ranging from prevention, guided self-help, and treatment and is both consistent with treatment guidelines and also an effective use of, often limited, university resources.

Fall 2012 Volume 13, Number 2

Health Highlights Treatment EBT is essential in a stepped-care model. EBT ED psychotherapies predominantly integrate behavioral therapy with cognitive, interpersonal, dynamic, dialectical, and other mindfulness-based techniques towards regulating caloric intake and weight and addressing weight and shape concerns. Despite significant support for these treatments, the field of ED treatment research faces ongoing significant challenges. These include significant percentages of patients who do not fully recover, which in part relates to treatment refusal, poor motivation for and engagement in treatment, and high attrition and dropout rates – as high as 73% for outpatient treatment. Although EDs are very serious illnesses that impact medical and psychological health, part of the pathology of EDs involves denial about the severity of the illness and/or unwillingness or hesitation to change unhealthy behaviors. As a result, patients are frequently not motivated to participate in treatment and work towards behavior change, leading to premature treatment drop-out. High attrition rates increase the likelihood of lifetime duration of the illness and draw attention to the need for interventions that target patients’ motivation to make behavioral changes and participate in the full course of treatment. Once a disorder of clinical severity is diagnosed, the number of treatment options that are indicated is diagnosis-dependent, and, unfortunately, not always available. Anorexia Nervosa (AN) For the acute phase of AN there are still no EBTs for adults, though a particular form of family based treatment developed at the Maudsley (sometimes referred to as the “Maudsley Model”) is most promising for adolescents with short illness duration (i.e., less than 3 years).36-40 Furthermore, there are currently no medications that have demonstrated efficacy for adults with AN.41 The lack of EBTs for adults is in part due to the difficulty in conducting treatment outcome research with this population, with small sample sizes and about a 50% drop out rate, making the development of treatments that are acceptable to adults a priority. Research groups that have explored treatments for adults have argued that no further randomized clinical trials should be conducted until more acceptable treatments have been developed. Currently, adult treatment for anorexia nervosa tends to be eclectic, drawing on cognitive behavioral therapy (CBT), interpersonal therapy (IPT), and dialectical behavioral therapeutic (DBT) approaches towards the aim of nutritional rehabilitation, normalizing eating and exercise, and addressing weight and shape concerns. There are no data to guide appropriate dosage of treatment, though the recovery process

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for adults can be several years in duration. Given significant medical sequelae, psychotherapeutic treatment should always include monitoring by a physician experienced in physiological effects of the illness. About 90% of people with AN can be treated as an outpatient, and while medical hospitalization may be required throughout the course of treatment, there is currently no evidence that demonstrates long-term outcomes from residential psychiatric inpatient stays. Bulimia Nervosa (BN) The situation is better for BN. Increased prevalence allows for studies with larger sample sizes, and treatment appears to be more acceptable, drop-out rates range from 5-27%.41 Evidence suggests that CBT is the treatment of choice, superior to supportive-expressive therapy, IPT and anti-depressant medication.42, 43 CBT achieves abstinence (from binge eating and purging) among about 25-35% of patients, and about half no longer meet criteria for BN.41 The major goals of CBT are normalization of eating pattern and subsequent cessation of binge eating/purging cycle. IPT has similar rates of success at one-year, but it is a longer treatment.43 DBT appears to be promising for BN; however, more research is needed.44 Pharmacotherapy has also demonstrated more success for BN than for AN, with 60 mgs of Fluoxetine showing efficacy and being the only drug currently approved by the FDA; however, as with many medications, long-term maintenance of efficacy is a problem. Guided self-help interventions are usually based on CBT and have shown promise for BN, demonstrating superiority over wait list controls, and abstinence rates ranging from 9%-60%.45 One study also demonstrated its superiority over family-based therapy.46 These interventions are promising, because they can be delivered in a stepped care framework and guidance can be provided by relatively junior health staff (e.g., interns and postdoctoral fellows), making them accessible and cost-efficient interventions ideal for college counseling campuses. Binge Eating Disorder (BED) For the treatment of BED, CBT and IPT appear to be equally effective at reducing binge eating and are recommended as EBTs, although neither lead to weight reduction.47 Some psychopharmacological interventions appear to be promising, such as the use of Fluoxetine and an anticonvulsant agent such as Topiramate that may reduce binge eating and stimulate weight loss.42 Guided self-help interventions are not as widely explored for the treatment of binge ED as in BN but may also be promising for BED.42

Novel Approaches Cognitive Remediation Interventions. Recent studies have explored the use of novel interventions targeting neurocognitive factors in an attempt to improve outcomes associated with existing treatments. College represents the end of the period of plasticity of the brain; thus, the impact of EDs on the brain (e.g., decreased brain volume due to malnourishment) likely becomes more entrenched. Studies evaluating the role of development/age, length of illness, and neurocognition suggest that brain health may become an increasingly important factor in helping both identify and remediate EDs.48 Early evidence suggests that the transition between age 19 and 21 appears significant for changing neuropsychological response on critical items related to ED psychopathology.48 Motivational Enhancement. In spite of the need for interventions designed to enhance ED patients’ engagement in treatment, there continues to be a lack of effective, widely available, and empirically-supported motivational enhancement programs for EDs – especially for college populations. Although the existing literature demonstrates promising results among inpatient and outpatient populations at end-of-intervention and 6-week follow-up, they have yet to examine this among college populations or demonstrate longer-term effects on treatment dropout and attrition. In an effort to address this gap, one of the projects in our Stanford ED Research Laboratory aims to target motivation and attrition among college students with EDs through offering a course aimed at promoting healthy behaviors, increasing motivation to make healthy behavior choices, and preparing students with ED symptoms in the clinical range for treatment.49 Due to increased popularity in recent years across college campuses in positive psychology, compassion-training, values-based, happiness, gratitude, mindfulness, and empowerment classes and workshops (e.g., the infamous Positive Psychology, or “Happiness Course,” offered at Harvard University; the popular YesPlus course offered across college campuses by the international, non-profit, humanitarian organization The Art of Living), this course utilizes a framework that integrates these themes to engage students both at-risk for and with fullydeveloped EDs. Ultimately, the course aims to increase students’ body satisfaction and healthy, values-based behaviors related to EDs and related difficulties (e.g., eating, exercise, drinking, sexual behaviors, self-injurious behaviors, etc.). The first stages of this research appear promising and may offer a new approach to engaging college populations and addressing their unique needs.

Health Highlights Coordination and Care Across the College Campus College campuses can be a valuable source of potential resources for students struggling with eating and weight issues. Universities should be attentive to ED symptoms among students and use early intervention strategies to minimize the disruption of students’ academic life, as EDs can compromise students’ health to the point where they are no longer able to remain in school. Coordination of care works best when there is a clearly articulated plan for assessing and treating students with eating-related issues, and when there is regular communication among those involved in developing and implementing treatment plans.50 It is recommended that college counseling centers have individuals or teams that focus specifically on the assessment and treatment of students with EDs. Most college counseling centers are only able to provide limited brief psychotherapy for students given the high demand on their services. For some individuals, a brief course of an EBT, such as CBT, may be sufficient. However, specialized clinical services involving a full-course of evidence-based psychotherapy combined with medical management and nutrition consultation is often required and is the standard of care for full-syndrome EDs.34 Universities can leverage the collaboration and expertise within student health services to establish an ED care team of therapists, physicians, and nutritionists with specialized training in EDs. Even when students are referred to outside specialists, they often require regular medical monitoring upon returning to school or as they transition to a lower level of care. An ED care team can provide a safety net to ensure that students maintain treatment gains and help prevent relapse by facilitating prompt identification and referral for students. Having a clear protocol for assessing, diagnosing and treating students with EDs, as well as for determining when students can no longer remain in school due to these illnesses, allows for effective provision of care, coordination of services, and communication with families. If regular staff do not have training in treating EDs, student health services who treat students with EDs should arrange for visiting ED specialists to spend designated hours at the health center or establish a referral relationship with a nearby medical center. Behavioral medicine departments often have clinicians specifically trained in treating EDs who can be an asset in providing services. Those involved in the assessment and treatment of EDs should have regular contact with Resident Advisors (RA’s) and Resident

Directors (RD’s). Being directly involved with students on a daily basis, RA’s and RD’s are often the first to notice that a student is having a problem related to food and weight. Professors are another source for recognizing and calling attention to a potential problem, and should know whom to contact within the university if they suspect a student is in need of help. When working with students who struggle with food and weight issues, especially younger students (i.e. freshman), involving parents is an important step in providing care.51 Even while students are away in school, parents can be an invaluable source of support for their child. Any time a student is potentially going to be released from school, parents should be notified, told about the treatment plan, and told how they can support their child, well in advance of any forced leave. University dining services can also be a valuable resource for helping create a healthy eating environment that supports all students in learning how to make balanced, nutritious choices. Dining services can work with nutritionists and counseling staff to offer programming about mindful eating, combating myths about weight gain during college, and teaching students living in apartment-style residences basics about meal preparation. This can mitigate some of the challenges associated with having unlimited food choices, novel and unfamiliar foods, and a preponderance of foodbased activities. In sum, EDs are common and serious problems among college students and necessitate early intervention for effective treatment. College and universities can play a pivotal role in identifying and addressing EDs, both to facilitate treatment and to support students in fulfilling their academic missions. A gold standard for care on a college campus should follow a stepped-care approach and involve ED screening, universal and targeted prevention (e.g., StudentBodies; 31), indicated prevention or guided self-help for subclinical EDs, and evidence-based comprehensive clinical services. Essential to this model is collaboration among campus administrators, staff, and student leaders in order to foster an environment that supports healthy eating and body image enhancement for all students.

References 1. D Eisenberg et al., “Eating Disorder Symptoms among College Students: Prevalence, Persistence, Correlates, and Treatment-Seeking,” J Am Coll Health 59, no. 8 (2011): 700-7.

2. National Eating Disorders Association, “National Eating Disorders Association Announces Results of Eating Disorders Poll on College Campuses across the Nation,” Market Wire Available at: http://findarticles. com/p/articles/mipwwi/is/ain16742451(September 2006). 3. S White, Reynolds-Malear, JB, & Cordero, E, “Disordered Eating and the Use of Unhealthy Weight Control Methods in College Students: 1995, 2002, and 2008,” Eating Disorders 19(2011): 323-34. 4. SL Hoerr et al., “Risk for Disordered Eating Relates to Both Gender and Ethnicity for College Students,” J Am Coll Nutr 21, no. 4 (2002): 307-14. 5. JL & Smith Zagorsky, PK, “The Freshman 15: A Critical Time for Obesity Intervention or Media Myth?,” Social Science Quarterly 92(2011): 1389407. 6. JI Hudson et al., “The Prevalence and Correlates of Eating Disorders in the National Comorbidity Survey Replication,” Biological Psychiatry 61(2007): 348-58. 7. M Trockel, Weisman, H, Kass, A, Iacovino, JM, Sinton, M, Wilfley, DE, & Taylor, CB, “A Model for Integrated Screening, Primary Prevention and Treatment of Eating Disorders in College-Age Women,” (Under review). 8. Reid F Morgan JF, Lacey JH “The Scoff Questionnaire: Assessment of a New Screening Tool for Eating Disorders,” British Journal of Medicine 319(1999): 1467-8. 9. Jacobi et al., “Prevalence, Co-Morbidity and Correlates of Mental Disorders in the General Population: Results from the German Health Interview and Examination Survey (Ghs),” Psychol Med 34, no. 4 (2004): 597-611. 10. SB Austin et al., “Screening High School Students Fo Eating Disorders: Results of a National Initiative,” Preventing Chronic Disease 5, no. 4 (2008): 1-10. 11. APA, Diagnostic and Statistical Manual of Mental Disorders, (Washington, DC: Author, 1994). 12. AM Darcy et al., “The Eating Disorders Examination in Adolescent Males: How Does It Compare to Adolescent Females? ,” International Journal of Eating Disorders Jan45, no. 1 (2012): 110-4. 13. A Darcy, “Gender Issues in Child and Adolescent Eating Disorders,” in The Oxford Handbook of Child and Adolescent Eating Disorders: Developmental Perspectives, ed. James Lock (New York, New York: Oxford University Press, 2012). 14. CJ Russell and PK Keel, “Homosexuality as a Specific Risk Factor for Eating Disorders in Men,” International Journal of Eating Disorders 31(2001): 300-6. 15. DJ Carlat, CA Camargo, and DB Herzog, “Eating Disorders in Males: A Report on 135 Patients,” American Journal of Psychiatry 154, no. 8 (1997): 1127-32. 16. E Bramon-Bosch, NA Troop, and J Treasure, “Eating Disorders in Males: A Comparison with Female Patients,” European Eating Disorders Review 8, no. 321-328 (2000). 17. U Hepp and G Milos, “Gender Identity Disorder and Eating Disorders,” International Journal of Eating Disorders 32(2002): 473-8.

Fall 2012 Volume 13, Number 2

Health Highlights 18. U Hepp, G Milos, and H Braun-Scharm, “Gender Identity Disorder and Anorexia Nervosa in Male Monozygotic Twins,” International Journal of Eating Disorders 35(2004): 239-43. 19. J Croll et al., “Prevalence and Risk and Protective Factors Related to Disordered Eating Behaviors among Adolescents: Relationship to Gender and Ethnicity.,” Journal of Adolescent Health 31, no. 2 (2002): 166-75. 20. D. Neumark-Sztainer and PJ Hannan, “WeightRelated Behaviors among Adolescent Girls and Boys: Results from a National Survey.,” Archives Pediatric and Adolescent Medicine 154, no. (6) (2000): 569-77. 21. R Striegel-Moore et al., “Psychiatric Comorbidity of Eating Disorders in Men: A National Study of Hospitalized Veterans,” International Journal of Eating Disorders 25(1999): 399-404.

22. C Jacobi, SW Bryson, and DW Wilfley, “Who Is Really at Risk: Identifying Risk Factors for Subthreshold and Full Syndrome Eating Disorders in a High-Risk Sample,” Psychological Medicine Jan 31(2011): 1-11. 23. AM Prouty, HO Protinsky, and D Canady, “College Women: Eating Behaviors and Help-Seeking Preferences,” Adolescence 37, no. 146 (2002): 353-63. 24. Wilson GT Striegel-Moore RH, DeBar L, Perrin N, Lynch F, Rosselli F, Kraemer HC, “Cognitive Behavioral Guided Self-Help for the Treatment of Recurrent Binge Eating,” J Consult Clin Psychol 78, no. 3 (2010): 312-21. 25. CB Becker, Bull, S, Schaumberg, K, Cauble, A, & Franco, A, “Effects of Peer-Facilitated Eating Disorders Prevention: A Replication Trial,” Journal of Consulting and Clinical Psychology 76(2008): 347-53. 26. JA Matusek, Wendt, SJ, & Wiseman, CV, “Dissonance Thin-Ideal and Didactic Healthy Behavior Eating Disorders Prevention Programs: Results from a Controlled Trial,” International Journal of Eating Disorders 36(2004): 376-88. 27. E Stice, Marti, N, Spoor, S, Presnell, K, & Shaw, H, “Dissonance and Healthy Weight Eating Disorder Prevention Programs: Long-Term Effects from a Randomized Efficacy Trial,” Journal of Consulting and Clinical Psychology 76, no. 329-340 (2008). 28. E Stice, H Shaw, and CN Marti, “A MetaAnalytic Review of Eating Disorder Prevention Programs: Encouraging Findings,” Annu Rev Clin Psychol 3(2007): 207-31. 29. CG Fairburn, Z Cooper, and R Shafran, “Cognitive Behaviour Therapy for Eating Disorders: A “Transdiagnostic” Theory and Treatment.,” Behaviour Research and Therapy 41(2003): 509-28. 30. JR Grant and TF Cash, “Cognitive-Behavioral Body Image Therapy: Comparative Efficacy of Group and Modest-Contract Treatments,” Behaviour Therapy 26, no. 1 (1995): 69-84. 31. CB Taylor et al., “Prevention of Eating Disorders in at-Risk College-Age Women,” Arch Gen Psychiatry 63, no. 8 (2006): 881-8. 32. C Jacobi et al., “Who Is Really at Risk? Identifying Risk Factors for Subthreshold and Full Syndrome Eating Disorders in a High-Risk Sample,” Psychol Med 41, no. 9 (2011): 1939-49. 33. O’Dea JA Yager Z, “Prevention Programs for Body Image and Eating Disorders on University Campuses: A Review of Large, Controlled

Harvard Health Policy Review

Interventions,” Health Promot Int. 23, no. 3 (2008): 173-89. 34. American Psychiatric Association, “Practice Guidelines for Eating Disorders,” American Journal of Psychiatry (2000). 35. C Jacobi, Volker, U, Trockel, M., Taylor, CB , “Effects of an Internet-Based Intervention for Subthreshold Eating Disorders: A Randomized Controlled Trial,” Behaviour Research and Therapy (In press). 36. J Lock et al., “A Comparison of Short- and Long-Term Family Therapy for Adolescent Anorexia Nervosa,” Journal of Amercan Acadamy for Child and Adoelscent Psychiatry 44(2005): 632-9. 37. D le Grange et al., “Evaluation of Family Therapy in Anorexia Nervosa: A Pilot Study.,” International Journal of Eating Disorders 12, no. 347-357 (1992). 38. J Lock, J Couturier, and WS Agras, “Comparison of Long-Term Outcomes in Adolescents with Anorexia Nervosa Treated with Family 39. Therapy,” Journal of American Academy of Child and Adolescent Psychiatry 45(2006): 666-72. 40. AL Robin et al., “A Controlled Comparison of Family Versus Individual Therapy for Adolescents with Anorexia Nervosa. ,” Journal of the American Academy of Child and Adolescent Psychiatry 38(1999): 1482-9. 41. J Lock et al., “A Randomized Clinical Trial Comparing Family-Based Treatment to Adolescent Focused Individual Therapy for Adolescents with Anorexia Nervosa,” Archives of General Psychiatry Oct;67, no. 10 (2010): 1025-32. 42. WS Agras and AH Robinson, “Forty Years of Progress in the Treatment of the Eating Disorders.,” Nordic Journal of Psychiatry 62, no. Suppl 47 (2008): 19-24. 43. DM Garner et al., “Comparison of CognitiveBehavioural and Supportive-Expressive Therapy for Bulimia Nervosa. ,” American Journal of Psychiatry 150(1993): 37-45. 44. W. Agras et al., “A Multicenter Comparison of Cognitive-Behavioural Therapy and Interpersonal Psychotherapy for Bulimia Nervosa.,” Archives of General Psychiatry 57(2000): 459-66. 45. DL Safer, CF Telch, and WS Agras, “Dialectical Behavior Therapy for Bulimia Nervosa,” American Journal of Psychiatry 158(2001): 632-4. 46. R Sysco and BT Walsh, “A Critical Evaluation of the Efficacy of Self-Help Interventions for the Treatment of Bulimia Nervosa and Binge Eating Disorders,” International Journal of Behaviour Medicine 41(2008): 97-112. 47. U Schmidt et al., “A Randomized Controlled Trial of Family Therapy and Cognitive Behavior Therapy Guided Self-Care for Adolescents with Bulimia Nervosa and Related Disorders,” American Journal of Psychiatry 164(2007): 591-8. 48. KA Brownley et al., “Binge Eating Disorder Treatment: A Systematic Review of Randomized Controlled Trials,” International Journal of Behaviour Medicine 40(2007): 337-48. 49. Fitzpatrick, Paper presented at the scientific meeting for the Eating Disorder Research Society. (2011). 50. M Stewart, (2012). 51. A Becker, Franko, D, Nussbaum, K, & Herzog,

D, “Secondary Prevention for Eating Disorders: The Impact of Education, Screening, and Referral in a College-Based Screening Program.,” International Journal of Eating Disorders 36(2004): 157-62. 52. KL Loeb et al., “Eating Disorders in Youth: Diagnostic Variability and Predictive Validity,” Int J Eat Disord (2009).

Dr. Megan Jones is a Clinical Instructor in the Department of Psychiatry at Stanford University Medical Center where she directs the Stanford Healthy Body Image Program and provides clinical services in the Eating Disorders Program. Her research focuses on eating disorder and obesity prevention for adolescents and college-age students. Dr. Alison Darcy is a post-doctoral research fellow in eating disorders research program where she conducts research on patients’ perspectives of treatment, males with eating disorders, and helped coordinate the DSM-IV Field Trials. Dr. Danielle Colborn is a post-doctoral fellow in the Eating Disorders Research Program at Stanford University Medical Center. She provides therapeutic interventions for youth and families and conducts research on treatment interventions. Dr. Maria-Christina Stewart is a post-doctoral fellow in the Eating Disorders Research Program at Stanford University Medical Center. Her research examines cognitive variables related to eating disorders, the impact of culture and ethnicity on treatment outcomes, and the efficacy of socialemotional and mindfulness treatment programs for youth with eating disorders. Dr. Kara Fitzpatrick is an Instructor in Department of Psychiatry and Behavioral Sciences at Stanford University Medical Center. Her research and clinical interests focus on the development of Cognitive Remediation Therapy (CRT), which utilizes neuropsychological components to address cognitive and behavioral difficulties associated with eating disorders.

The Coop knows what students need and has been providing the right products, service and advice for more than 130 years. You’ll find all the textbooks for all your courses in all the format options (New- Used- Ebooks and now Rental Textbooks) as well as the widest and deepest selection of Harvard logo merchandise anywhere (present your student ID and receive 15% off logo clothing). You’ll find school supplies and dorm needs too. Coop staff is knowledgeable and will provide the right advice. Find all this in one convenient location- only at the Coop. The Coop has been Harvard’s campus store since 1882 and was started by Harvard students and established as a cooperative that would share its profits with members. Harvard students are eligible to join the Coop and save money. Last year Coop members received 8.0% of their Coop purchases back as patronage rebate. The Coop has been an integral part of the Harvard experience for generations and consistently supports student events, activities, public service, publications, arts and performances, athletics and more. Visit thecoop. com and click on Coop Gives to see a list of recipients. Become a Coop member and continue the tradition. Join online at thecoop.com or in any Coop store. Image Citations

3. “Regulatory Burdens of the Affordable Care Act.” Picture 1, courtesy of < http://www.shorelinerecordsmanagement.com/

1. “Health Policy After the Election.” October 4th, 2012.

education-center/medical-record-reference-guide/>.

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Courtesy of <http://cancer.tipstimes.com/breast-cancer/item/200images-of-breast-cancer>. 8. “Food Democracy on the March.” Courtesy of Vera Kratochvil. 9. “Cost Savings in the Emergency Department.” Courtesy of Getty Images. 10. “Eating Disorders on College Campuses.” Picture 1, courtesy of Rega Photography. Picture 2, courtesy of Blaj Gabriel. 11. “Fixing Medicaid.” Courtesy of < httpss//my.barackobama. com/page/content/benefitsofreform>. 12. “Covered, California.” Courtesy of < http://openclipart.org/ detail/813/stethoscope-by-johnny_automatic>. 13. Affects of the Affordable Care Act on Safety-Net Providers. Courtesy of < http://www.desales.edu/images/pa-program/desalesfree-clinic-11-2011.jpg?sfvrsn=4>.