Editors’ Note: The attack in Nice will inevitably, and appropriately, lead to more aggressive intelligence efforts against suspected ISIS networks and tighter security in general, writes Dan Byman. Unfortunately, they are also likely to bolster anti-Muslim voices in France and throughout Europe, and ISIS may in turn exploit Muslims’ resulting shame and anger. This post originally appeared on Slate.

At least 84 people are dead in Nice, France, after a truck deliberately plowed for over a mile through packed crowds celebrating Bastille Day; ISIS or one of its supporters is believed to be linked to the attack. As we reel in horror from yet another instance of terrorist carnage, news reports are trickling in, giving us a sense of the attack, its victims, and those behind the killings.

We’ll learn more in the days to come, but we already knew Europe—and France in particular—has a terrorism problem and that it may go from bad to worse in the near future. Ironically, one of the reasons for the increased attacks is the military successes the United States, France, and other countries and local fighters are scoring against ISIS’s core in Iraq and Syria and the setbacks suffered by ISIS’s key provinces such as that in Libya. ISIS, which had long trumpeted its success in establishing the now-shrinking caliphate, needs victories to compensate for these major losses. Earlier this month, CIA Director John Brennan warned, “As the pressure mounts on ISIL, we judge that it will intensify its global terror campaign to maintain its dominance of the global terrorism agenda.”

Running down people with a truck is a new form of violence for ISIS, though ISIS propaganda has called for supporters to kill by “ramming” people, al-Qaida’s Yemen branch recommended it in the past to “mow down the enemies of Allah,” and in 2008 a Palestinian used a bulldozer to kill three Israelis. But this is the fourth major terror attack in Europe in the past eight months: ISIS-directed terrorists killed 130 people in November in Paris; in March suicide bombers killed 32 people in Brussels, and just two weeks ago three men believed to be tied to ISIS killed more than 40 at the Istanbul airport.

The attacks will inevitably, and appropriately, lead to more aggressive intelligence efforts against suspected ISIS networks and tighter security in general. Unfortunately, they are also likely to bolster anti-Muslim voices in France and throughout Europe, fostering daily humiliations and furthering Muslim communities’ sense that they are suspect and under siege. ISIS will exploit the resulting shame and anger, increasing the risk of future attacks.

European nations face several types of terror threats from ISIS. The first is the unprecedented number of fighters—more than 5,000—that Europe has exported to Iraq and Syria to fight under the banners of ISIS and other jihadi groups. More than 900 of them (including 200 women) have come from France. More than 130 are dead, and almost 250 have returned; the rest are believed to still be in Iraq and Syria. The Paris attacks, which were coordinated and practiced, illustrate the danger such fighters can pose: Time in the battle zone allows them to gain fighting skills, become indoctrinated, and develop a network to exploit for future attacks. In addition, ISIS leaders can direct their operations to achieve maximal effect. As the so-called caliphate shrinks, more of these fighters may try to return. More than 1,000 other Frenchmen are believed to be radicalized but have not gone to Iraq and Syria, and this represents another overlapping danger. In the past many might have tried to go to Syria, but now, perhaps acting on directions from ISIS leaders with whom they are communicating or perhaps mixing with returned foreign fighters, these individuals might strike directly at France or other countries.

The last category are true “lone wolves”—those inspired by ISIS or other jihadi ideologies but with no direct operational connection to a group (the attacks in San Bernardino and Orlando appear to fall into this category). Two years ago ISIS propaganda emphasized coming to the “caliphate” to help it consolidate and expand. Earlier this year, however, its spokesman and external operations leader Muhammad al-Adnani declared, “The smallest action you do in the heart of their land is dearer to us than the largest action by us and more effective and more damaging to them.”

France, as we’ve seen, is particularly vulnerable. As my Brookings colleagues Will McCants and Chris Meserole have recently argued, French political culture is a counterterrorism problem. They found that “four of the five countries with the highest rates of radicalization in the world are Francophone, including the top two in Europe (France and Belgium).” Part of the problem are the large numbers of unemployed urban youth, a fertile field for radical recruiting. But part of it is also France’s aggressive secularization programs, which prohibit girls from wearing the veil in school and are considered by many Muslims to be a deliberate attack on their religion. Muslims’ trust in the government and security services is low. Add such a sense of humiliation to a surging far-right political movement that constantly blasts Muslim immigrants and citizens, and the conditions for radicalization are strong.

The United States is less vulnerable by comparison. Fewer than 300 Americans have gone to fight in Iraq and Syria. Part of this is because of an aggressive and effective law enforcement and intelligence effort to disrupt volunteers. But part of it is because the American Muslim community is far better integrated than its French counterpart and regularly cooperates with law enforcement. U.S. politics are becoming more poisonous toward Muslims, but—we can hope—that anti-Muslim sentiment in America may have peaked, and recent polls suggest positive attitudes toward Muslims are increasing.

Continued military and intelligence operations against the ISIS core by U.S.-led coalition forces and their local partners are necessary, but they will take time to bear fruit and in the end still don’t solve the terrorism problem. Stopping an attack like the one in Nice is exceptionally difficult. The attacker chose a “soft” (undefended) target and showed that one sick person can kill many with the right combination of determination and luck. Unfortunately, the most likely reaction after the Nice attack is also the worst one: more vitriol and hostility toward French and European Muslims, furthering a cycle that makes it harder for European security services to gain the cooperation of local communities and easier for ISIS to gain recruits and score victories.

Last night, retired lieutenant general Michael Flynn addressed the Republican convention as a headline speaker on the subject of national security. One of Donald Trump’s closest advisors—so much so that he was considered for vice president—Flynn repeated many of the themes found in his new book, The Field of Fight, How We Can Win the Global War Against Radical Islam and Its Allies, which he coauthored with Michael Ledeen. (The book is published by St. Martin’s, which also published mine.)

Written in Flynn’s voice, the book advances two related arguments: First, the U.S. government does not know enough about its enemies because it does not collect enough intelligence, and it refuses to take ideological motivations seriously. Second, our enemies are collaborating in an “international alliance of evil countries and movements that is working to destroy” the United States despite their ideological differences.

Readers will immediately notice a tension between the two ideas. “On the surface,” Flynn admits, “it seems incoherent.” He asks: 

“How can a Communist regime like North Korea embrace a radical Islamist regime like Iran? What about Russia’s Vladimir Putin? He is certainly no jihadi; indeed, Russia has a good deal to fear from radical Islamist groups.” 

Flynn spends much of the book resolving the contradiction and proving that America’s enemies—North Korea, China, Russia, Iran, Syria, Cuba, Bolivia, Venezuela, Nicaragua, al-Qaida, Hezbollah, and ISIS—are in fact working in concert.

No one who has read classified intelligence or studied international relations will balk at the idea that unlikely friendships are formed against a common enemy. As Flynn observes, the revolutionary Shiite government in Tehran cooperates with nationalist Russia and communist North Korea; it has also turned a blind eye (at the very least) to al-Qaida’s Sunni operatives in Iran and used them bargaining chips when negotiating with Osama bin Laden and the United States. 

Flynn argues that this is more than “an alliance of convenience.” Rather, the United States’ enemies share “a contempt for democracy and an agreement—by all the members of the enemy alliance—that dictatorship is a superior way to run a country, an empire, or a caliphate.” Their shared goals of maximizing dictatorship and minimizing U.S. interference override their substantial ideological differences. Consequently, the U.S. government must work to destroy the alliance by “removing the sickening chokehold of tyranny, dictatorships, and Radical Islamist regimes.” Its failure to do so over the past decades gravely imperils the United States, he contends.

The book thus offers two very different views of how to exercise American power abroad: spread democracies or stand with friendly strongmen...[P]erhaps it mirrors the confusion in the Republican establishment over the direction of conservative foreign policy.

Some of Flynn’s evidence for the alliance diverts into the conspiratorial—I’ve seen nothing credible to back up his assertion that the Iranians were behind the 1979 takeover of the Grand Mosque in Mecca by Sunni apocalypticists. And there’s an important difference between the territorially-bounded ambitions of Iran, Russia, and North Korea, on the one hand, and ISIS’s desire to conquer the world on the other; the former makes alliances of convenience easier than the latter. Still, Flynn would basically be a neocon if he stuck with his core argument: tyrannies of all stripes are arrayed against the United States so the United States should destroy them.

But some tyrannies are less worthy of destruction than others. In fact, Flynn argues there’s a category of despot that should be excluded from his principle, the “friendly tyrants” like President Abdel-Fatah el-Sissi in Egypt and former president Zine Ben Ali in Tunisia. Saddam Hussein should not have been toppled, Flynn argues, and even Russia could become an “ideal partner for fighting Radical Islam” if only it would come to its senses about the threat of “Radical Islam.” Taken alone, these arguments would make Flynn realist, not a neocon. 

The book thus offers two very different views of how to exercise American power abroad: spread democracies or stand with friendly strongmen. Neither is a sure path to security. Spreading democracy through the wrong means can bring to power regimes that are even more hostile and authoritarian; standing with strongmen risks the same. Absent some principle higher than just democracy or security for their own sakes, the reader is unable to decide between Flynn’s contradictory perspectives and judge when their benefits are worth the risks. 

It’s strange to find a book about strategy so at odds with itself. Perhaps the dissonance is due to the co-authors’ divergent views (Ledeen is a neocon and Flynn is comfortable dining with Putin.) Or perhaps it mirrors the confusion in the Republican establishment over the direction of conservative foreign policy. Whatever the case, the muddled argument offered in The Field of Fight demonstrates how hard it is to overcome ideological differences to ally against a common foe, regardless of whether that alliance is one of convenience or conviction. 

Event Information

On July 20 and 21, defense ministers from several nations will gather in Washington, D.C. at the invitation of U.S. Secretary of Defense Ash Carter. The meeting will bring together representatives from countries working to confront and defeat the Islamic State (or ISIL). French Defense Minister Jean-Yves Le Drian will be among those at the summit discussing how to accelerate long-term efforts to fight ISIL in Iraq and Syria. The close relationship between France and the United States has provided a solid base for security cooperation for decades, and in recent years, France has become one of America’s strongest allies in fighting terrorism and a prominent member of the international coalition to defeat ISIL.

On July 20, the Foreign Policy program at Brookings hosted Minister Le Drian for a discussion on French and U.S. cooperation as the two countries face multiple transnational security threats. Since becoming France’s defense minister in 2012, Le Drian has had to address numerous new security crises emerging from Africa, the Middle East, and within Europe itself. France faced horrific terrorist attacks on its own soil in January and November 2015 and remains under a state of emergency with its armed forces playing an active role in maintaining security both at home and abroad. Le Drian recently authored “Qui est l’ennemi?” (“Who is the enemy?”, Editions du Cerf, May 2016), defining a comprehensive strategy to address numerous current threats.

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In his wide-ranging interview with The New York Times, Republican presidential nominee Donald J. Trump stressed the importance of fighting ISIS while declaring “we are going to take care of this country first before we worry about everybody else in the world.” For counterterrorism (and I would argue for security in general), such thinking is dangerously wrong-headed: Fighting ISIS and stopping other foreign terrorist threats to the U.S. homeland requires close alliances and deep engagement abroad.

Allies may also have better access to a terrorist stronghold due to geography or historic ties. Saudi Arabia, Turkey, and Jordan are within easy bombing range of ISIS’ core: the U.S. homeland is not. Although military action against ISIS’ core in Iraq and Syria is vital, it is often quiet global intelligence cooperation that does much of the day-to-day counterterrorism lifting. Given the geographic span of ISIS operations, it is not realistic for the United States to have strong unilateral capabilities in every possible country where the terrorists might operate and use as a base for anti-U.S. operations. Foreign governments fill this gap, acting as a force multiplier for the United States. Shortly after 9/11, the United States was working with over 100 countries on counterterrorism; several years into the war on terror a senior CIA official testified that virtually every capture or killing of a suspected terrorist outside Iraq involved at least some help from a foreign intelligence service. 

Many allies have skilled intelligence services, and they also use their police and their domestic intelligence services to gather information. These services of course know local languages and are culturally aware. They can also take advantage of the law in their efforts to disrupt terrorism: Terrorism, after all, is a crime. Allies, particularly less savory ones, use a government’s coercive power as well. Although people automatically think torture, governments at times threaten to jail a relative of a suspected terrorist or withhold a business permit or the right to attend university. These seemingly mundane threats are something that the United States cannot do outside its own borders. 

Many of the most basic homeland security tasks do not begin or end with the homeland.

Given these advantages, the primary role of U.S. intelligence is to cajole and strengthen allies, not replace them. The United States might provide technical assistance, as many U.S. allies are far weaker in this area. In addition, U.S. intelligence often acts as a conductor of global liaison services. In 2010, al-Qaida of the Arabian Peninsula tried to bomb two cargo planes as they approached the United States. Efforts to disrupt the plot involved not only the United States and Yemen, but also the countries in transit, including Qatar, the United Arab Emirates, Germany, and the United Kingdom. And Saudi Arabia provided a key intelligence tip. 

Many of the most basic homeland security tasks do not begin or end with the homeland. Foreign governments provide information on terrorist suspects, and there is considerable cooperation on those who might travel to the United States. Much of the screening to hinder terrorist travel and operations is done “over there,” not in the United States.

Our world is too small, and terrorists too global, to think of U.S. security narrowly. If we want to fight ISIS and other foes, we need allies. That doesn’t mean we should do whatever our allies want or support them unconditionally. But we must recognize that if we expect them to help America fight its enemies, we must stand by them as well.

France has been struck by an unprecedented three terror attacks in the last 18 months. In what’s called Operation Sentinelle, 13,000 French military personnel now patrol streets and protect key sites across the country, assisting police and other security agencies. “The fact that the armed forces are visible,” said French Defense Minister Jean-Yves Le Drian at a Brookings event on July 20, “help to reassure the French people that they are safe both at home and abroad.”

Do the challenges facing France today mean that it should reduce its engagement overseas, focusing instead on security at home? Le Drian doesn’t think so, and I agree. In a new book titled "Who is the Enemy?," he particularly emphasizes the multifaceted ISIS threat. As he said at Brookings: 

"Every war [has] two enemies…[Today’s] war [with ISIS] also sets in place two concepts of the “enemy” that are radically different: From a strategic point of view, we are dealing with a proto-state; at the heart of this entity, there is a terrorist army." 

It only further complicates matters, of course, that France faces ISIS threats on several fronts: in Syria and Iraq, on the one hand, and also on its own territory. This, Le Drian stressed, means “we must seek coherence in our military action.” It also helps explain why France remains one of the most active countries in the fight against the so-called Islamic State, as well as other extremist groups in the Middle East and in sub-Saharan Africa. In 2013 and 2014, France intervened in Mali in order to prevent jihadi groups from taking over the country. The French military also has a presence in Djibouti, Lebanon, Côte d’Ivoire, the Central African Republic, Gabon, Senegal, as well as in the Pacific (in French Polynesia and New Caledonia)—not to mention Syria, where France uses the Mediterranean Sea-based Charles de Gaulle aircraft carrier to strike ISIS targets. 

France is not a warmongering country—rather, it is responding to the fact that overseas threats come to it. Although it remains unclear to what extent the Nice attacker had connections with foreign terrorist networks, it has been established that the November 2015 Paris attacks were planned and orchestrated from Syria. This, among other considerations, has prompted France to engage further in Iraq and Syria. The rationale, as Minister Le Drian explained, is: 

“[T]rading our peace by reducing our military involvement doesn’t make sense. The more we let ISIS consolidate its presence on the Middle East, the more it will gather resources, attract fighters, and plan more attacks against us.” 

Team player

French policy isn’t just about ensuring its own security—rather, its many contributions are integrated within global efforts, including U.S.-led ones. As Le Drian said at Brookings: “I am convinced that the French-American relationship is stronger and better than ever.” France is a prominent participant of the 66-member international coalition against ISIS, and in that capacity participated in the first joint meeting of that group’s foreign and defense ministers in Washington this month. 

France remains a key member of the joint military operation Inherent Resolve in Iraq and Syria, which has damaged or destroyed over 26,0000 ISIS-related targets since August 2014. The Charles de Gaulle carrier—with 26 aircrafts on board—has been an essential part of that coalition mission. Following specific instructions from U.S. Defense Secretary Ash Carter and his counterpart in Paris, Minister Le Drian, French and U.S. intelligence agencies cooperate closely in intelligence-sharing. And just last week, President François Hollande announced that France will soon be supplying artillery to Iraq to support its fight against ISIS. Beyond the Iraq-Syria theater, France is cooperating with the United States and other partners in Libya, another country that is both a victim and source of extremist threats. 

The French Defense Ministry’s efforts to double-down on protecting French citizens within France, therefore, has not reduced its overseas role. Particularly now that the United Kingdom will leave the European Union, France’s military role has never been so important. France—along with Germany, which recently suggested it would raise its defense spending significantly—should continue to play a leading role as one the top defense actors in the West. 

Media coverage of the Islamic State has focused on the group’s grotesque use of violence and archaic governance style. Less attention has been paid, however, to the institutions that make those practices possible—institutions that lend the group legitimacy, at least in the eyes of supporters, as a sovereign state. In her new Brookings Analysis Paper, “The legal foundations of the Islamic State,” Mara Revkin argues that legal institutions play a critical role in the Islamic State’s state-building project. Those structures help the group take and keep territory, as well as provide a measure of accountability to the people living under its rule.

Lesser evil?

Revkin writes that “the Islamic State has attempted to ingratiate itself with civilians by claiming that its legal system is comparatively more legitimate and effective than the available alternatives.” The Syrian and Iraqi governments, Revkin explains, are often perceived as being highly corrupt and ineffective. The Islamic State is able to gain civilians’ favor by arguing that its political and legal institutions are more legitimate than those of the Syrian and Iraqi governments or rival armed groups. She adds: “some Syrians and Iraqis seem to prefer the legal system of the Islamic State to the available alternatives not because they agree with its ideology, but simply because they regard it as the lesser evil.” 

The Syrian and Iraqi governments...are often perceived as being highly corrupt and ineffective.

Revkin writes that for the Islamic State, shariah law is “the only legitimate basis for governance.” In cases where shariah fails to address modern-day problems, she explains, religiously legitimate authorities appointed by the Islamic State—such as military commanders, police officers, and the caliph himself—can issue legal decisions as long as they do not conflict with the divine rules of shariah or harm the welfare of the greater Muslim community. Alongside this is a system of rules and regulations to “govern civilians, discipline its own officials and combatants, and control territory” in areas of rights and duties, behavior, property, trade, and warfare. 

Making the state possible

Legal institutions help the Islamic State advance three main state-building objectives, in Revkin’s view: 

1. First, they support the Islamic State’s territorial expansion by “legitimizing [its] claims to sovereignty, justifying the expropriation of the property and land of enemies, and building goodwill with civilians.” 
2. Legal institutions also allow the Islamic State to enforce compliance and accountability of its own members and maintain internal control and discipline. Revkin describes various types of punishments the Islamic State uses to discipline its own members—these punishments are important, she writes, because “no government can establish itself as legitimate and sovereign without policing the behavior of the people who are responsible for implementing its policies.”
3. Finally, Revkin explores the legal institutions surrounding the Islamic State’s tax policies, which are “critical to financing the Islamic State’s governance and military operations.” Courts and judges, she explains, are crucial to “administering and legitimizing” taxation and justifying “economic activities that might otherwise resemble theft.” 

Weaknesses in the system

Although the Islamic State claims to have legitimate governing authority, based on a defined legal system, that system faces vulnerabilities. Revkin writes, for instance, that reports of corruption and extra-legal violence are “threatening the organization’s long-term sustainability and undermining its ability to win the trust and cooperation of civilians.”

Amid recent signs that the group is losing strength, Revkin argues that it’s struggling to maintain its own moral standards. To further weaken the Islamic State, she recommends working to undermine those institutions. The trouble is, as Revkin points out: “the Islamic State came to power largely by exploiting the weakness and illegitimacy of existing institutions” in Iraq and Syria. Thus, a sustainable plan for ultimately destroying the organization must also involve strengthening political and legal institutions in those countries. 

Executive Summary

Large-scale antipoverty programs have achieved significant and positive results in many developing countries around the world in the past decade. This paper explores the challenges of “scaling up” small-scale antipoverty programs—taken here to mean the processes by which successful efforts to raise the incomes of the poorest citizens in developing counties are expanded in coverage over time and across geography. In particular, I advocate supplementing approaches that highlight resource and program constraints with an expanded focus on the political dynamics involved in expanding pro-poor policies. Thus, greater emphasis should be placed on understanding the political factors that limit the expansion and survivability of antipoverty programs. A broader view along these lines highlights the bargaining strength of beneficiaries, the need to secure public support, the potential for political misuse of antipoverty programs, and how institutional fragilities affect their sustainability. Antipoverty programs can be effectively scaled up if attention is paid to addressing these political and institutional challenges. An agenda for future research is also identified.

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Summary

At the Gleneagles Summit in 2005, leaders of the G8 group of nations committed to increase aid to poor nations by $50 billion per year. During the same year, in a meeting in Paris, donors promised to coordinate their interventions for more effective delivery. These commitments are now often referred to as the promise of donors to “scale up aid.” Increasing aid flows and improving coordination are indeed important goals and, in fact, goals that donors seem to have trouble meeting. The international donor community met this fall in Accra and will meet in Doha in November 2008 to review progress with this aspect of scaling up aid, and it is hoped that they will recommit to meet the ambitious targets set three years ago.

Scaling up aid is only one of the challenges that donors face. A more important challenge is to “scale up through aid,” meaning that aid flows should not merely support short-lived, one-time and partial development interventions—pilot projects, short-term technical assistance, programs that only address part of the problem, but leave major bottlenecks unaddressed—but should support projects, programs and policies that scale up successful interventions in a country, region or globally to reach the entire target population. Scaling up means that programs are long-term and sustained and that external support is aligned with country needs and deals comprehensively with the development challenges—often by working in partnership with other donors and pooling resources. This is the scaling up challenge that donors should address head-on, but so far have not.

This policy brief reports on the findings of an in-depth review of the literature and practice of scaling up development interventions and focuses on the role that aid donors can play in supporting scaling up for effective development. It stresses that successful scaling up with external assistance means that donor agencies need to: work with a vision and leadership; help create the political constituencies for large-scale implementation; create linkages among project, program and policy interventions; strengthen the institutional capacity of the implementing entities; provide for effective incentives and accountabilities of their own staff and management; work together with each other; monitor and evaluate the progress of programs with special attention to the scaling up dimension; and finally make sure they focus on effective preparation and flexible implementation of the scaling up process. While this is a long-term agenda, donors can take a few practical steps right away that will provide a basis for a more ambitious effort over time.

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Abstract

Scaling up of development interventions is much debated today as a way to improve their impact and effectiveness. Based on a review of scaling up literature and practice, this paper develops a framework for the key dynamics that allow the scaling up process to happen. The authors explore the possible approaches and paths to scaling up, the drivers of expansion and of replication, the space that has to be created for interventions to grow, and the role of evaluation and of careful planning and implementation. They draw a number of lessons for the development analyst and practitioner. More than anything else, scaling up is about political and organizational leadership, about vision, values and mindset, and about incentives and accountability—all oriented to make scaling up a central element of individual, institutional, national and international development efforts. The paper concludes by highlighting some implications for aid and aid donors.

An annotated bibliography of the literature on scaling up and development aid effectiveness was created by Oksana Pidufala to supplement this working paper. Read more »

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A key objective of the United Nations Development Programme (UNDP) is to assist its member countries in meeting the Millennium Development Goals (MDGs). UNDP pursues this objective in various ways, including through analysis and advice to governments on the progress towards the MDGs (such as support for the preparation and monitoring Poverty Reduction Strategies, or PRSs, in poor countries), assistance for capacity building, and financial and technical support for the preparation and implementation of development programs.

The challenge of achieving the MDGs remains daunting in many countries, including Tajikistan. To do so will require that all development partners, i.e., the government, civil society, private business and donors, make every effort to scale up successful development interventions. Scaling up refers to “expanding, adapting and sustaining successful policies, programs and projects on different places and over time to reach a greater number of people.” Interventions that are successful as pilots but are not scaled up will create localized benefits for a small number of beneficiaries, but they will fail to contribute significantly to close the MDG gap.

This paper aims to assess whether and how well UNDP is supporting scaling up in its development programs in Tajikistan. While the principal purpose of this assessment was to assist the UNDP country program director and his team in Tajikistan in their scaling up efforts, it also contributes to the overall growing body of evidence on the scaling up of development interventions worldwide.

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Editor's Note: The World Bank’s Independent Evaluation Group (IEG) recently published a self-evaluation of its activities. Besides representing current thinking among evaluation experts at the World Bank, it also more broadly reflects some of the strengths and gaps in the approaches that evaluators use to assess and learn from the performance of the international institutions with which they work. The old question “Quis custodet ipsos custodes?” – loosely translated as “Who evaluates the evaluators?” – remains as relevant as ever. Johannes Linn served as an external peer reviewer of the self-evaluation and provides a bird’s-eye view on the lessons learned.

An Overview of the World Bank’s IEG Self-Evaluation Report

In 2011 the World Bank’s Independent Evaluation Group (IEG) carried out and published a self-evaluation of its activities. The self-evaluation team was led by an internal manager, but involved a respected external evaluation expert as the principal author and also an external peer reviewer.

The IEG self-evaluation follows best professional practices as codified by the Evaluation Cooperation Group (ECG). This group brings together the evaluation offices of seven major multilateral financial institutions in joint efforts designed to enhance evaluation performance and cooperation among their evaluators. One can therefore infer that the approach and focus of the IEG self-evaluation is representative of a broader set of practices that are currently used by the evaluation community of international financial organizations.

At the outset the IEG report states that “IEG is the largest evaluation department among Evaluation Capacity Group (ECG) members and is held in high regard by the international evaluation community. Independent assessments of IEG’s role as an independent evaluation function for the Bank and IFC rated it above the evaluation functions in most other ECG members, international nongovernmental organizations, and transnational corporations and found that IEG follows good practice evaluation principles.”

The self-evaluation report generally confirms this positive assessment. For four out of six areas of its mandate IEG gives itself the second highest rating (“good”) out of six possible rating categories. This includes (a) the professional quality of its evaluations, (b) its reports on how the World Bank’s management follows up on IEG recommendations, (c) cooperation with other evaluation offices, and (d) assistance to borrowing countries in improving their own evaluation capacity. In the area of appraising the World Bank’s self-evaluation and risk management practices, the report offers the third highest rating (“satisfactory”), while it gives the third lowest rating (“modest”) for IEG’s impact on the Bank’s policies, strategies and operations. In addition the self-evaluation concludes that overall the performance of IEG has been “good” and that it operates independently, effectively and efficiently.

The report makes a number of recommendations for improvement, which are likely to be helpful, but have limited impact on its activities. They cover measures to further enhance the independence of IEG and the consistency of evaluation practices as applied across the World Bank Group’s branches – the World Bank, the International Finance Corporation (IFC), and the Multilateral Investment Guarantee Agency (MIGA) –; to improve the design of evaluations and the engagement with Bank management upstream for greater impact; and monitoring the impact of recent organizational changes in IEG in terms of results achieved. The report also recommends that more be done to evaluate the Bank’s analytical work and that evaluations draw on comparative evidence.

Assessment

In terms of the parameters of self-evaluation set by the prevailing practice among the evaluators on international financial agencies, the IEG self-evaluation is accurate and helpful. From my own experience as an operational manager in the Bank whose activities were evaluated by IEG in years past, and as a user of IEG evaluations (and of evaluations of other international aid organizations) for my research on aid effectiveness, I concur that IEG is independent and effective in meeting its mandate as defined. Moreover, the self-evaluation produces useful quantitative evidence (including survey results, budget analysis, etc.) to corroborate qualitative judgments.

However, the self-evaluation suffers from a number of limitations in approach and gaps in focus, which are broadly representative of the practices prevalent among many of the evaluation offices of international aid agencies.

Approach of the IEG self-evaluation

The core of the self-evaluation report is about the evaluation process followed by IEG, with very little said about the substance of IEG’s evaluations. The following questions could have usefully been raised, but were not: do evaluations cover the right issues with the right intensity, such as growth and poverty; environmental, governance, and gender impacts; regional dimensions versus exclusive country or project focus; effectiveness in addressing the problems of fragile and conflict states; effectiveness in dealing with global public goods; sustainability and scaling up; etc. Therefore the report does not deal with the question of whether IEG effectively responds in its evaluations to the many important strategic debates and issues with which the development community is grappling.

Related to this limitation is the fact that the report assessed the quality of IEG’s mostly in terms of (a) whether its approach and processes meet certain standards established by the Evaluation Cooperation Group; and (b) how it is judged by stakeholders in response to a survey commissioned for this evaluation. Both these approaches are useful, but they do not have any basis in professional assessments of the quality of individual products. This is equivalent to IEG evaluating the World Bank’s projects on the quality of its processes (e.g., appraisal and supervision processes) and on the basis of stakeholder surveys, without evaluating individual products and their impacts.

Gaps in the Self-Evaluation and in Evaluation Practice

Careful reading of the report reveals six important gaps in the IEG self-evaluation, in the prevailing evaluation practice in the World Bank, and more generally in the way international financial organizations evaluate their own performance. The first three gaps relate to aspects of the evaluation approach used and the second three gaps relate to lack of focus in the self-evaluation on key internal organizational issues:

1. Impact Evaluations: The report notes that IEG carries out two to three impact evaluations per year, but it sidesteps the debate in the current evaluation literature and practice as to what extent the “gold standard” of randomized impact evaluation should occupy a much more central role. Given the importance of this debate and divergence of views, it would have been appropriate for the self-evaluation to assess IEG’s current practice of very limited use of randomized evaluations.

2. Evaluation of Scaling Up: The report does not address the question of to what extent current IEG practice not only assesses the performance of individual projects in terms of their outcomes and sustainability, but also in terms of whether the Bank has systematically built on its experience in specific projects to help scale up their impact through support for expansion or replication in follow-up operations or through effective hand-off to the government or other partners. In fact, currently IEG does not explicitly and systematically consider scaling up in its project and program evaluations. For example, in a recent IEG evaluation of World Bank funded municipal development projects (MDPs) , IEG found that the Bank has supported multiple MDPs in many countries over the years, but the evaluation did not address the obvious question whether the Bank systematically planned for the project sequence or built on its experience from prior projects in subsequent operations. While most other evaluation offices like IEG do not consider scaling up, some (in particular those of the International Fund for Agricultural Development and the United Nations Development Program) have started doing so in recent years.

3. Drawing on the Experience of and Benchmarking Against Other Institutions: The self-evaluation report does a good job in benchmarking IEG performance in a number of respects against that of other multilateral institutions. In the main text of the report it states that “IEG plans to develop guidelines for approach papers to ensure greater quality, in particular in drawing on comparative information from other sources and benchmarking against other institutions.” This is a welcome intention, but it is inadequately motivated in the rest of the report and not reflected in the Executive Summary. The reality is that IEG, like most multilateral evaluation offices, so far has not systematically drawn on the evaluations and relevant experience of other aid agencies in its evaluations of World Bank performance. This has severely limited the learning impact of the evaluations.

4. Bank Internal Policies, Management Processes and Incentives: IEG evaluations traditionally do not focus on how the Bank’s internal policies, management and incentives affect the quality of Bank engagement in countries. Therefore evaluations cannot offer any insights into whether and how Bank-internal operating modalities contribute to results. Two recent exceptions are notable exceptions. First, the IEG evaluation of the Bank’s approach to harmonization with other donors and alignment with country priorities assesses the incentives for staff to support harmonization and alignment. The evaluation concludes that there are insufficient incentives, a finding disputed by management. Second, is the evaluation of the Bank’s internal matrix management arrangements, which is currently under way. The self-evaluation notes that Bank management tried to quash the matrix evaluation on the grounds that it did not fall under the mandate of IEG. This is an unfortunate argument, since an assessment of the institutional reasons for the Bank’s performance is an essential component of any meaningful evaluation of Bank-supported programs. While making a good case for the specific instance of the matrix evaluation, the self-evaluation report shies away from a more general statement in support of engaging IEG on issues of Bank-internal policies, management processes and incentives. It is notable that IFAD’s Independent Office of Evaluation appears to be more aggressive in this regard: It currently is carrying out a full evaluation of IFAD’s internal efficiency and previous evaluations (e.g., an evaluation of innovation and scaling up) did not shy away from assessing internal institutional dimensions.

5. World Bank Governance: The IEG self-evaluation is even more restrictive in how it interprets its mandate regarding the evaluation of the World Bank’s governance structures and processes (including its approach to members’ voice and vote, the functioning of its board of directors, the selection of its senior management, etc.). It considers these topics beyond IEG’s mandate. This is unfortunate, since the way the Bank’s governance evolves will substantially affect its long-term legitimacy, effectiveness and viability as an international financial institution. Since IEG reports to the Bank’s board of directors, and many of the governance issues involve questions of the board’s composition, role and functioning, there is a valid question of how effectively IEG could carry out such an evaluation. However, it is notable that the IMF’s Independent Evaluation Office, which similarly reports to the IMF board of directors, published a full evaluation of the IMF’s governance in 2008, which effectively addressed many of the right questions.

6. Synergies between World Bank, IFC and MIGA: The self-evaluation report points out that the recent internal reorganization of IEG aimed to assure more effective and consistent evaluations across the three member branches of the World Bank Group. This is welcome, but the report does not assess how past evaluations addressed the question of whether the World Bank, IFC and MIGA effectively capitalized on the potential synergies among the three organizations. The recent evaluation of the World Bank Group’s response to the global economic crisis of 2008/9 provided parallel assessments of each agency’s performance, but did not address whether they work together effectively in maximizing their synergies. The reality is that the three organizations have deeply engrained institutional cultures and generally go their own ways rather than closely coordinating their activities on the ground. Future evaluations should explicitly consider whether the three effectively cooperate or not. While the World Bank is unique in the way it has organizationally separated its private sector and guarantee operations, other aid organizations also have problems of a lack of cooperation, coordination and synergy among different units within the agency. Therefore, the same comment also applies to their evaluation approaches.

Conclusions

Self-evaluations are valuable tools for performance assessment and IEG is to be congratulated for carrying out and publishing such an evaluation of its own activities. As for all self-evaluations, it should be seen as an input to an independent external evaluation, a decision that, for now, has apparently been postponed by the Bank’s board of directors.

IEG’s self-evaluation has many strengths and provides an overall positive assessment of IEG’s work. However, it does reflect some important limitations of analysis and of certain gaps in approach and coverage, which an independent external review should consider explicitly, and which IEG’s management should address. Since many of these issues also likely apply to most of the other evaluation approaches by other evaluation offices, the lessons have relevance beyond IEG and the World Bank.

Key lessons include:

• An evaluation of evaluations should focus not only on process, but also on the substantive issues that the institution is grappling with.
• An evaluation of the effectiveness of evaluations should include a professional assessment of the quality of evaluation products.
• An evaluation of evaluations should assess:
  o How effectively impact evaluations are used;
  o How scaling up of successful interventions is treated;
  o How the experience of other comparable institutions is utilized;
  o Whether and how the internal policies, management practices and incentives of the institution are effectively assessed;
  o Whether and how the governance of the institution is evaluated; and
  o Whether and how internal coordination, cooperation and synergy among units within the organizations are assessed.

Evaluations play an essential role in the accountability and learning of international aid organizations. Hence it is critical that evaluations address the right issues and use appropriate techniques. If the lessons above were reflected in the evaluation practices of the aid institutions, this would represent a significant step forward in the quality, relevance and likely impact of evaluations.

The only interlocutor for the United States in Turkey will be President Recep Tayyip Erdoğan from now on, Professor Kemal Kirişci has said, adding that Washington has come to recognize the reality that whoever becomes the prime minister “knows he is not going to do anything that is unauthorized.”

The U.S. has lost its hopes regarding Turkish democracy, according to Kirişci, who is at the Washington-based Brookings Institute.

Prior to President Erdoğan’s visit, there were a record number of articles saying he would not receive a warm welcome in Washington, let alone a meeting with U.S. President Barack Obama. Yet Erdoğan ended up in the White House for a long meeting.

I was able to observe both of his visits in May 2013, and the one that took place last March. The difference is day and night. In 2013 the U.S. administration was bending over backwards to welcome Erdoğan, and he was hosted very lavishly.

The last visit was also preceded by the article of Jeff Goldberg, where there was a reference to how disappointed Obama was with his relationship with Erdoğan. I think that the appointment was given because Turkey and the president of Turkey is very central and critical to the fight against the Islamic State of Iraq and the Levant (ISIL). This is the only reason why this appointment was given; this is my reading.

The meeting took place despite Obama’s disillusionment with Erdoğan. Does that mean that Turkey is indispensable, regardless of rules Turkey? Or is Erdoğan not expendable?

Both. The term that is being used in Washington for the U.S. relationship with Turkey is “transactional,” meaning wherever we have common interests and common concerns, we are going to try to cooperate. The idea of a model partnership based on shared liberal values is no longer an issue; the cooperation is out of necessity.

Was there ever a Davutoğlu effect in bilateral relations, since he was one of the figures shaping foreign policy?

Starting in September 2015, Davutoğlu projected the image of a pragmatic person wanting to address a problem. The way in which he handled the European migration crisis was assessed as something positive compared to the rhetoric the president uses where he is constantly criticizing and using contemptuous – almost denigrating – language toward Europe but also the U.S. I suspect that Davutoğlu was offered an audience with Obama [shortly after his meeting with Erdoğan] because of this.

How do you think Washington will see his departure?

At the micro level, they thought that there was room for a pragmatic, solution-oriented relationship with Davutoğlu. But in the course of the last year or two, they had also come to realize that Davutoğlu’s foreign policy based around his book “Strategic Depth” was producing conflict between Turkey and the U.S. – the conflict areas being Syria, ISIL, Egypt, Israel and Iraq. 

Do you think there will be any changes in relations with Davutoğlu’s departure?

I think there is a recognition in Turkey, Europe, the U.S. and the rest of the world that from today onward, Turkey’s foreign policy will be run by the president. The notion that Turkey is a parliamentary system and the president is supposed to be equidistant from political parties does not reflect reality. The U.S., with this experience behind them, has come to recognize this reality. Whoever becomes the PM, they know he is not going to do anything that is unauthorized. The consequence is that Turkey-U.S. relations will not be where they were when Erdoğan first came to power; that’s how I can answer the question because it is comparative. At that time, in addition to Syria, trade, the economy and Turkey’s relations with the EU were also on the agenda.

These issues will no longer be on the agenda; there will be only one issue: the Syrian issue. [But another will be how will] NATO manage the challenges that Russia is bringing to European security? I think there is some room for interaction there.

Has the U.S. given up on Turkey as a reliable ally sharing the same values? 

It is sad but that is the reality. Turkey’s agenda today in the neighborhood is not an agenda that overlaps with the Western transatlantic community’s agenda. There is a lot of aggravation that emerges from that reality. For the U.S., the issue of ISIL is regarded as the major challenge emanating from the Middle East to U.S. and European security. I think they have reached a conclusion that cooperating with Turkey is an uphill battle. They also recognized Turkey and the U.S. have conflicting interests with respect to the PYD [Democratic Union Party]. Turkey considers it a threat to national security whereas the U.S. sees the PYD as an actor with which they are able to cooperate against ISIL in a decisive, reliable and credible manner. In the case of Turkey, there is cooperation but there are question marks over the reliability and credibility and commitment of Turkey.

Why are you using the word sad?

It is sad from a personal point of view because when you look at the world right now, it looks like there are two governance system competing with each other. One governance system is the system to which I thought Turkey was always committed. We became a member of NATO, Council of Europe and the OECD. We aspire to become part of the EU because I suppose we believed the values of members of this community provides more prosperity, stability and security to its citizens. Then there is an alternative form of governance represented by Russia, Iran and China [based on] the idea that the state should have a greater say on the economy, the state interest should prevail over the interests and the rights of individuals and that freedom of expression and media can be curtailed to serve state interests. Turkey is increasingly moving in the direction of this second form of governance.

Why, then, did Brookings invite Erdoğan, producing embarrassing moments when the president’s security detailed interfered with demonstrators?

Brookings has a long-established program called the Global Leaders Forum and invites presidents and prime ministers to give speeches. It is an independent think tank and does not confer legitimacy or illegitimacy on a speaker. The Washington audience got an opportunity to see how Turkey is being governed.

It looks like the U.S. remains indifferent to democratic backpedalling in Turkey.

There was a time at meetings on Turkey in which questions were raised along the lines of, “Why isn’t the U.S. doing more against this backsliding?” Interestingly, in the course of about six months or so, this question is being raised less and less. The U.S. has lost hopes about Turkish democracy. The primary reason for this is that they have this impression that Turkish society, especially after what happened after the June [2015] elections, gives priority to this kind of governance. Also, the Obama administration, especially compared to the Bush and Clinton administrations, is less comfortable with the idea of promoting democracy and supporting democratization.

The interview was originally published in Hürriyet Daily News.

On 15 May the Dominican Republic held its most complex elections since 1994. On this occasion, not only were the president and vice president elected, but also all the members of the lower house, the Chamber of Deputies, and the Senate, as well as local authorities.

There were no surprises. Danilo Medina, of the governing Partido de la Liberación Dominicana (PLD), was re-elected by a large margin, and all indications are that he was also able to conserve his party’s majority in both houses of Congress. We say “all indications are” because the election was beset by irregularities (well-documented by the OAS observer mission); and these irregularities have triggered a serious post-electoral crisis that has yet to be fully resolved.

Medina’s re-election confirms the infallibility of the rule (in place in Latin America since 1978) that every president who reforms the Constitution to keep himself in power has achieved his objective. The only exception was Hipólito Mejía, former president of the Dominican Republic, who amended the Constitution in 2002 to seek a second term, but then failed to get re-elected. This defeat opened the door for the return of Leonel Fernández (also of the PLD), who had already governed from 1996 to 2000, and who won the 2004 election and then (benefitting from Mejía’s reform) got himself re-elected in 2008. Once in office, Fernández reformed the Constitution in 2010 (moving from allowing consecutive re-election to allowing unlimited re-election but with alternating rather than consecutive terms). President Medina amended the Constitution once again, in 2015, on an expeditious basis (within 15 days) to re-enact consecutive re-election and to run again in the elections just held on 15 May. No other country in Latin America has amended the constitutional provision on re-election so many times in such a short period, four times in 21 years. 

Continuity of the PLD for the fourth consecutive term 

With this clear-cut triumph by Medina (he garnered 61.74 per cent of the votes, leading the second-place challenger Luis Abinader, of the recently-formed Partido Revolucionario Moderno (PRM), by more than 25 points), the PLD has now won the presidency for the fourth time in a row, with a total (at the end of this new term) of 16 years in power without interruption. Never before under democratic rules of the game had the same party won four times in a row in the Dominican Republic. 

If we exclude the special cases of the PRI in Mexico (prior to 2000) and the Partido Colorado (in Paraguay), from 1978 to date only four parties or coalitions have won four consecutive presidential contests in the region: Chavismo in Venezuela, which has been in power for 17 years (now in the midst of a profound crisis that could lead to Maduro’s early exit); Brazil’s Workers’ Party (PT), which so far (we’ll see what comes of the trial of Rousseff by the Senate that is about to get under way) has been in power for 13 years; ARENA in El Salvador (which governed without interruption from 1989 to 2009 with presidents Cristiani, Sol, Flores, and Saca); and the Concertación in Chile (from 1990 to 2010, with presidents Aylwin, Frey, Lagos, and Bachelet in her first term). 

Reasons for the victory

What are the reasons that explain Medina’s landslide victory after three consecutive terms of the PLD in office?

In my opinion, a combination of personal, political, and socioeconomic reasons explain this outcome. As to the personal reason, one should highlight the great popularity of President Medina. With approval ratings greater than 70 per cent, he enjoys high levels of popular support, much more than any other Latin American president.

In terms of the political reasons, one should note the advantage that any Latin American president has when seeking consecutive re-election: the enormous concentration of power by the PLD in all areas of the State, accentuated political clientelism, and above all, an opposition that has not figured out a strategy for removing the PLD from power. Mention should also be made of the marked lack of fairness in the electoral contest and the abusive use of state resources in favor of the governing party.

The third important reason that explains Medina’s easy re-election is to be found in the economy. With 7 per cent growth and inflation at 2.5 per cent, the Dominican Republic is one of the two best-performing economies in the region (the other is Panama). This growth stands in stark contrast to a Latin America which (according to World Bank projections) will see negative growth of -0.6 per cent this year. It is also more than 2 percentage points greater than the average growth rate for the countries of Central America.

Challenges

Yet Medina’s second term, despite the strong support he received at the polls, is not problem-free. On the contrary, he faces major challenges, including having the results of the 15 May elections accepted by the opposition so that his legitimacy and, above all, that of the PLD legislators and mayors, will not be called into question.

Improving the quality of democracy is another major challenge. The Dominican Republic is part of the group of countries (according to The Economist) that has a flawed democracy, characterized by marked institutional weakness and high levels of citizen insecurity and corruption. 

Moreover, profound and urgent changes are needed in the political–electoral system aimed at improving the quality and integrity of the electoral process to avoid having to suffer similar problems in future elections. 

In the electoral sphere, the OAS report recommends that it is important to separate voting for members of the lower house from voting for senators. It is also important to provide for fairer electoral competition. This requires adequate regulation of the use of state resources (to keep the party in power from enjoying unfair advantages), strengthening the levels of transparency, oversight, control of political financing (establishing, among other measures, ceilings for campaign spending and limits on private financing), as well as assuring more equal access to the media. 

As regards the political system, the priority includes introducing thorough changes in the party system aimed at modernizing the parties, institutionalizing them and improving their levels of internal democracy. Another priority is ensuring effective gender parity in politics. 

These political–electoral changes need to be supplemented by adequate modernization and strengthening of the electoral organs (JCE - Central Elections Board and the TSE - Superior Electoral Tribunal), ensuring that they are made up of very qualified professionals of renowned prestige, who are totally independent of the political parties. In the area of the economy, despite the current positive macroeconomic outlook, the situation is far from ideal. 40 per cent of the population lives in poverty due to the economy’s serious difficulty generating quality employment (due to its growth model). To this we must add the need to solve the main limitation that the economy has faced for some time, i.e., scarce energy and high energy prices. 

In my opinion, this fourth consecutive victory consolidates the PLD as the predominant party in the Dominican political system (with the risk of becoming a hegemonic party). The PRD, which until recently was the main opposition party under the now-deceased Peña Gómez, weakened by its constant internal strife and divisions, ended up allying with the PLD in this election and won just over 5 per cent of the votes. The other major historical party, the PRSC, of deceased former president Joaquín Balaguer (which allied with the PRM in this election) also obtained few votes; its numbers similar to the PRD’s. The big question is what will happen in the coming years with the recently formed PRM and the leadership of Abinader, in particular, if both he and the party will be able to become consolidated as the main opposition force. 

One will also have to see whether Medina and the PLD have the capacity to steer clear of the attrition and crisis that generally affects “long governments” under a single party or coalition in the region, especially during the curse of the second consecutive term. Of the four “long governments” mentioned above, two, the PT in Brazil and chavismo in Venezuela, are currently experiencing serious crises that could lead to an early end of the terms of presidents Dilma Rousseff and Nicolás Maduro. 

In summary, during his second term Medina should implement an ambitious agenda of reforms. In politics, the priority includes modernizing and strengthening democratic institutions, adopting a law on political parties, and transforming the judiciary and the police to fight insecurity and corruption head on. In economic and social policy, the focus should be on maintaining high growth rates but correcting the serious prevailing inequalities and distortions with the objective of creating quality jobs and thereby reducing the high levels of poverty.

This piece was originally published by International IDEA. 

A central function of the United States Congress is oversight of the executive branch. Congressional oversight, as exercised from the beginning of the nation, is an essential tool in making the separation of powers real by empowering Congress to check the executive. In recent years, however, as polarization has reached paralyzing levels, Congress has largely gotten out of the business of routine and prospective “police-patrol” oversight.  In the absence of the will and the capacity to do prospective oversight, Congress is at risk of losing its power to the executive branch and thus failing one of its most important constitutional roles.

This paper assesses whether or not anything can be done to get Congress back into the oversight business. Specifically, author Elaine Kamarck examines the following question: Assuming that future Congresses develop the political will to conduct oversight, do they have the capacity to do oversight of a large, modern, and complex executive branch?

As Kamarck illustrates, mismatched resources may make it difficult for Congress to resume its oversight function. The modern federal government is a complex and enormous enterprise. But as the executive branch has grown considerably over the past decades, Congress has adopted budget cuts that make the legislative branch less and less capable of undertaking the kinds of systemic oversight that can solve or prevent problems. Congress employs a mere 17,272 professional staff to oversee an executive branch consisting of 4.2 million civil servants and uniformed military. 

“The existing infrastructure that is supposed to help Congress be on top of the executive branch has fallen prey to a mindless dumbing down of Congress,” Kamarck states. She details the five entities that are meant to support Congress in its oversight role: committee staff, the Congressional Research Service, the Government Accountability Office, the Congressional Budget Office, and the Inspectors General, all of which are understaffed and under-budgeted. Kamarck recommends the first thing Congress should do to fix its oversight problem is to properly staff the agencies it already has and to stop nickel and diming and degrading its own capacity.

Furthermore, Kamarck calls for a “Congressional Oversight Office,” a body charged with evaluating governmental performance before a crisis arises. This office should be staffed by implementation professionals who can gather the signals from all the other oversight organizations annually and in sync with the budget cycle.

“Congress needs to get back into the business of productive executive branch oversight,” concludes Kamarck. A Congressional Oversight Office is certainly a step in that direction.

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Recent political movements within the United States have raised concerns about the health of American democracy. With hyper-partisanship dividing the country and Donald Trump—the most unlikely, unsuitable, and unpopular presidential nominee of a major party in American history—securing the Republican nomination, the question emerges of whether democracy in America has gone awry.  And if so, is it too much or too little democracy that’s to blame?

To help address those questions, in this paper, Thomas E. Mann summarizes and discusses the findings of Christopher Achen and Larry Bartels’ ambitious treatise on American democracy: “Democracy for Realists.” Achen and Bartels contend that the traditional conception of voters as rational, attentive decision-makers does not hold against empirical evidence. Instead, voters are best understood as members of partisan groups, which influence their perception of candidates, issues, and even simple facts. According to Achen and Bartels, perceived social identities drive voting decisions, rather than rationality.

Mann notes that most scholars would agree that voters do not follow the expectations of idealistic models, but draws attention to competing theories that are far less damning to voters’ rationality. In particular, the research of Paul Sniderman and Arthur Lupia suggests that voters are far more capable than Achen and Bartels would assert. In their view, voters have enough rationality and information to ensure a well-functioning democracy.

As Mann summarizes the arguments:  Achen and Bartels believe that citizens and elections are held to impossible, idealistic standards in the folk theory of democracy, which perpetuates myths and works against government responsiveness. Sniderman and Lupia, on the other hand, are offended by those who dismiss citizens as ignorant and incompetent; they seek to defend voters’ dignity and demonstrate the rationality and efficacy of their behavior in American democracy.

What does this scholarship tell us about the coming presidential election, and the future of American democracy?  Ultimately, Mann concludes that Achen and Bartel’s perspective is not anti-democratic, even if it is built on a belief that too much importance is placed on the often random and myopic outcomes of elections.  Instead, Mann believes that “Democracy for Realists” reveals the real democratic deficit facing America is one stemming not from too much democracy, but  from “asymmetry in political resources and representation of different segments of American society.” Truly understanding this problem and its root cause is a step toward strengthening American democracy. 

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Data shows that white, poor, elderly, uneducated men from rural England pulled the United Kingdom outside the European Union. Great Britain will be on its own as it will have to navigate an increasingly complex and globalized world. Europeans must wish all the very best to their British friends. At the same time, they must explore what opportunities are there to be seized. Britain’s departure presents Europeans with many exciting political prospects.

Scotland

Unlike England, Scotland voted massively in favor of remaining within the European Union. Scots now risk being dragged out of it at the hands of the English. Because of this, Scottish First Minister Nicola Sturgeon has been clear: The possibility of a new referendum for Scottish independence is on the table. Should Scotland break free of England, it would immediately be welcome back into the European Union as a sovereign and independent country. Scots would have the best of both worlds: free of English dictates and welcome in the common European family. Their economic liberalism and progressive social policies meanwhile being a boon to the rest of Europe. 

Ireland

Although far less likely than those of a Scottish scenario, major changes could be afoot in Ireland as well. Ireland is presented with a fantastic opportunity to solidify its position as an outpost of Anglo-Saxon economic dynamism within the European Union. A global language, a flexible labour market and low corporate taxation (as well as great beer) are the ingredients the Irish bring to Europe. In the coming years, they could leapfrog what will be left of Britain as America’s springboard into Europe. Meanwhile, Dublin has a fantastic opportunity to punch above its weight in international affairs (as it could and should) by acting as an honest broker between Brussels and London.

International affairs

Calls for the establishment of a common European military, of shared European representation in international institutions, and of a truly European diplomatic service have for the last 40 years regularly and to varying degrees been frustrated by the United Kingdom. Now that Britain is out, Berlin, Paris, and all other like-minded member states should seize this historical opportunity in order to tremendously boost their cooperation in all these policy areas. By doing so, Europe could achieve economies of scale, save money and resources on possible duplications, boost its global standing, and become the strong and reliable partner that the United States desperately wants it to be.

The economy

The welfare state, public services, and healthcare that most continental and northern Europeans enjoy have long been far superior to anything most Brits can even dream of. Additionally, Germany and most northern European member states boost far more competitive economies and standards of living than the United Kingdom. The historical challenge for Europeans is now to improve the performance of the southern and eastern member states of the European Union. Free from British fears of Brussels’ red tape and with the crucial contribution of small yet economically dynamic countries such as the Netherlands or Sweden, Europeans should further integrate toward a dynamic yet inclusive social-market economic model.

Democracy

Westminster gave parliamentary democracy to the rest of the world. After having made a joke out of it through a referendum marred by enormous lies regurgitated onto an ill-informed population, Britain might have given a new impetus to democratic ideals across Europe. Two elements conspire positively in this respect. On the one hand, the country that historically more than any other opposed reforms aimed at further democratizing the European Union is out of the way: Britain will no more be able to veto reforms in this direction. On the other hand, both European elites and common citizens alike might now be spurred into further democratizing the EU as a means to rescuing it.

A rather homogenous socio-demographic group of white, poor, uneducated, elderly, and rural Englishmen have pulled the rest of Britain outside the European Union. The United Kingdom might now enter a new phase in its history characterized by a further deterioration of its international standing. Europeans, meanwhile, have to catch up on the time they spent dealing with 40 years of British foot-dragging. Great opportunities are out there to be seized.

Editor’s Note: In the aftermath of the United Kingdom's vote to leave the European Union, we are left with more questions than answers. Dhruva Jaishankar writes that with all the questions about what happens next, there's a bigger question worth asking: What are the implications of Brexit for democracy? Arguably, Brexit represents the first major casualty of the ascent of digital democracy over representative democracy. This piece was originally posted by The Huffington Post.

In the aftermath of the United Kingdom's vote to leave the European Union, we are left with more questions than answers. What kind of relationship will the UK now forge with the EU, and how will that affect economic relations and migration? Will Scotland and Northern Ireland opt to leave? What is the future of British politics, given turbulence within both the Conservative and Labour Parties? Will a successful Brexit set a precedent for other EU members -- perhaps even some eurozone members-- to leave the union? What are the long-term economic consequences of the resulting uncertainty? Will Brexit even happen at all, given the absence of a clear post-referendum plan, the apparent unwillingness of 'Leave' campaign leaders to invoke Article 50 of the Lisbon Treaty, and the fact that the referendum was advisory and non-binding? Answers to these questions will make themselves evident in the coming weeks, months, and years.

[D]igital democracy... has contributed to polarization, gridlock, dissatisfaction and misinformation.

But there's a bigger question worth asking: What are the implications of Brexit for democracy? Arguably, Brexit represents the first major casualty of the ascent of digital democracy over representative democracy. This claim deserves an explanation.

When historians look back at the world of the past 25 years, they will likely associate it not with terrorism or growing inequality but with the twin phenomena of the "rise of the rest" (particularly China and India) and of globalization. Globalization involves the easier, faster and cheaper flow of goods, people, capital and information. One big enabler of globalization is the internet, the global network of networks that allows billions of people to cheaply and easily access enormous amounts of digital information. The rise of service and high-technology industries, trade liberalization, container shipping, and the development of financial markets have also been important enablers, as is the increased ease and lower cost of travel, particularly by air.

Many technology optimists have assumed that globalization would lead to the democratization of information and decision-making, and also greater cosmopolitanism. Citizens would be better informed, less likely to be silenced, and able to communicate their views more effectively to their leaders. They would also have greater empathy and understanding of other peoples the more they lived next to them, visited their countries, read their news, communicated, and did business with them. Or so the thinking went.

[L]eaders only exploit the vulnerabilities of a post-fact world. The conditions have been laid by the digital sphere.

But there has been little to justify such panglossianism. There is some evidence for a correlation between greater information, political democratization and economic progress, in that all three have advanced steadily, if at different paces, over the past two decades. But that correlation is weak. Instead, digital democracy -- the ability to receive information in almost real time through mass media and to make one's voice heard through social media -- has contributed to polarization, gridlock, dissatisfaction and misinformation. This is as equally applicable to the countries in which modern democracy took root -- in the United States and Europe -- as it is to India, the biggest and most complex democracy in the developing world.

The ascent of digital democracy around the world has some shared features. One characteristic is that access to greater information has, rather counterintuitively, contributed to a "post-fact" information environment. Nick Cohen -- speaking of British pro-"Leave" journalists-turned-politicians Boris Johnson and Michael Gove --called out their use of bold claims, their contempt for practical questions, their sneering disregard for expertise, and their transgressions of the bounds of political spin. These tactics are not all that dissimilar to Donald Trump's assertions about Barack Obama's birth certificate or immigration policies, or Subramanian Swamy's insinuations about the nationality of senior Indian policymakers.

But leaders only exploit the vulnerabilities of a post-fact world. The conditions have been laid by the digital sphere. A recent example springs to mind. There is a widespread belief on Indian social media that US presidential candidate Hillary Clinton is somehow anti-India, pro-Pakistan, and/or anti-Modi. I am no supporter of Ms. Clinton, but as someone who worked on foreign affairs in Washington and knows many of her advisors, I found these claims baffling. In fact, Clinton's political opponents (whether Barack Obama in 2008 or Donald Trump in 2016) have accused her of being too close to India, while Pakistanis often view her as critical of their country and Prime Minister Modi appears to enjoy cordial relations with her. After some inquiries, and a few tips, I managed to trace these sentiments to a single publication, a poorly sourced and misleading column that gained widespread circulation upon its release. The article's contents were deemed sufficiently credible to have now become instilled as absolute fact in the minds of many Indians active online. In a digital democracy, a lie or (better yet) a half-lie if told enough times becomes truth.

In a digital democracy, a lie or (better yet) a half-lie if told enough times becomes truth.

Another outcome of digital democracy may be a variation of what the psychologist Barry Schwartz has called the paradox of choice. Quite possibly, the greater abundance of political choice leads to less satisfaction, and the result is citizens increasingly voicing their displeasure with their available political and policy choices. The political platforms of mainstream parties rarely adhere entirely to individual voters' views. That may explain why many voters are gravitating towards parties, factions or leaders who offer the simplest messages, and project themselves as alternatives to the mainstream.

A third result of digital democracy, and one that has been better documented, is the political echo chamber. Social media, rather than creating connections with people who possess differing views and ideologies, tends to reinforce prejudices. As the psychologist Nicholas DiFonzo has noted, "Americans across the political spectrum tend to trust the news media (and 'facts' provided by the media) less than their own social group." This makes it easier for views and rumours to circulate and intensify within like-minded groups. Similar digital gerrymandering was evident in the EU Referendum in Britain and the polarization is palpable in the Indian online political space.

Finally, instant information has increased the theatricality of politics. With public statements and positions by governments, political parties and individual leaders now broadcast to constituents in real time, compromise, a necessary basis of good governance, has become more difficult. When portrayed as a betrayal of core beliefs, compromise often amounts to political suicide. Political grandstanding also contributes to legislative gridlock, with elected representatives often resorting to walkouts, sit-ins, or insults -- all manufactured for maximum viral effect -- instead of trying to reach solutions behind closed doors. Even as ease of travel allows legislators to spend more time in their constituencies, making them more sensitized to their constituents' concerns, less gets done at the national or supranational level. It is a trend that, once again, applies equally to the United States, Europe, and India.

Social media, rather than creating connections with people who possess differing views and ideologies, tends to reinforce prejudices.

The unintended consequences of digital democracy -- misinformation and discontent, polarization and gridlock -- mean that the boundary between politician and troll is blurring. The tone of democratic politics increasingly reflects that of anonymous online discourse: nasty, brutish, and short. And successful politicians are increasingly those who are able to take advantage of the resulting sentiments. Exploiting divisions, appealing to base instincts, making outlandish claims, resorting to falsehoods, and pooh-poohing details and expertise. All that could just as easily describe the playbooks of populists around the world, on the right and left: Marine Le Pen, Frauke Petry, Donald Trump or Subramanian Swamy as much as Jeremy Corbyn, Beppe Grillo, Bernie Sanders or Arvind Kejriwal.

The unintended consequences of digital democracy -- misinformation and discontent, polarization and gridlock -- mean that the boundary between politician and troll is blurring.

In all these cases, populists are willing to cross the lines that mainstream parties have flirted with, becoming forces that the centre cannot hold. US Republicans fanned the anti-immigration sentiments that first the Tea Party and then Trump are only taking to their natural conclusions, just as mainstream Democrats' economic protectionism has been seized upon by Sanders. Cameron's euroscepticism, explained away initially as constructive criticism, spiralled out of control with Brexit, just as those who pronounced the death of New Labour helped paved the way for Corbyn. Will the same one day apply in India, to the economic populism of the Congress, of which Kejriwal has become a new torchbearer, or to the chauvinism of the right, which Swamy now threatens to run away with?

Brexit is not anti-globalization so much as a product of globalization. It is also a product of democracy rather than an affront to it. But it is a democracy of a different sort, one that many of its ideological forebears anticipated. When James Madison warned of "the superior force of an interested and overbearing majority," or John Stuart Mill cautioned against "a social tyranny more formidable than many kinds of political oppression," or BR Ambedkar argued (in a slightly different context) that "political tyranny is nothing compared to social tyranny," they could just as easily have been speaking in 2016 as in 1787, 1859, or 1936. Democrats around the world may not yet be married to the mob, but plenty have been betrothed.

None of this should be interpreted as some kind of nostalgia for an older, simpler world. That world was not necessarily simpler, but it was more violent and chaotic, prejudiced and unfair, and poor and backward. It may be hard to discern amid the smoke and noise, but there are some benefits to digital democracy. Information is no longer in the hands of the few. It is easier than ever to bring injustices to light. And the same process can throw up mainstream leaders from backgrounds that are far from privileged, such as a Barack Obama, Angela Merkel, or Narendra Modi. Two of the three, Obama and Modi, rose to power on the backs of unprecedented social media movements.

But representative democracy as we have come to know it is under threat, and Brexit represents the first major casualty. Rather than fight the tide, a collective rethink is needed about how to make democracies resilient and productive in the digital age. It won't be easy.

Editor's Note: With the latest coup attempt in Turkey, Turkish democracy survived a major test, and the country turned from the edge of a precipice. writes Kemal Kirisci. But Turkey’s democracy has also taken a severe blow. This article was originally published in The National Interest.

The history of Turkish politics is littered with coups and coup attempts that have occurred in roughly ten-year intervals. It is almost a genetic defect.

• The nascent Turkish democracy experienced its first coup in 1960 when it was barely into its tenth year—led by a group of left-wing “young officers,” who had also forced the General Staff into its ranks. Administrative authority was returned to civilians in October 1961, after having cost the lives of the then-Prime Minister, Adnan Menderes, the Minister of Foreign Affairs, Fatin Rüştü Zorlu, and the Minister of Finance, Hasan Polatkan.
• The second military intervention took place in 1971 against the government of Süleyman Demirel—this time around, though, through a “coup by memorandum.” The military issued to the prime minister an ultimatum—to step aside and be replaced by a technocratic cabinet.
• Less than ten years later, in the midst of endemic violence between left- and right-wing radical groups, the military's top brass carried out another intervention. This was bloodier than the previous two interventions, costing hundreds of lives and leading to massive human-rights violations. After rubberstamping a suffocating constitution on the country, the military handed the government over to a semblance of a democratically-elected government in 1983.
• Surprisingly, Turkey broke this pattern of ten-yearly military interventions, and civilian authority continued until 1997, when there was what was termed a “post-modern coup.” The army rolled out a convoy of tanks into the streets of Ankara, and in a repeat of the coup of 1971, demanded the resignation of the coalition government led by Necmettin Erbakan.
• The next coup occurred a decade later (almost to the day) in April 2007, when the Chief of Staff staged an “e-coup” by posting a set of demands on its website. The coup was a reaction against a long list of democratic reforms that were introduced as a part of the leadership’s pro-EU agenda and were seen as a departure from the staunchly secularist, restrictive mode of governance. Bolstered by the public support for these reforms, however, the incumbent Justice and Development Party (AKP) led by Recep Tayyip Erdoğan, now the current president of Turkey, successfully withstood the “e-coup,” and for the first time, pushed the military back “into the barracks”.

The latest coup attempt—which took place on Friday, July 15—has widely been attributed to a large Gülenist faction within the military and the judiciary that circumvented the established chain of command and held the high command hostage. Gülenists are the followers of the Islamic scholar Fethullah Gülen, who leads a worldwide movement that claims to advocate a moderate form of Sunni Islam with an emphasis on tolerance and interfaith dialogue. Formerly allies with Erdoğan, the Gülenists were blamed for spearheading the corruption scandal in December 2013 that engulfed several government officials, ministers and people in Erdoğan’s intimate circle. Since then, Gülen and Erdoğan have been locked in a power struggle.

Back from the brink

Turkish democracy survived a major test, and Turkey turned from the edge of a precipice. The credit for the coup’s defeat goes to the Turkish people, who heeded Erdoğan’s call to resist this intervention “by any means possible and necessary" and filled the squares. TV reports were filled with eye-to-eye, tense, agitated confrontations between civilians and armed soldiers on the two bridges that connect the Asian and European sides of Istanbul. Public restraint and sobriety helped to prevent escalation of violence. There were nevertheless senseless causalities resulting from fire opened by the mutineers and especially attacks mounted on the parliament building as well as the Headquarters of the General Staff. It could have been a lot worse.

Erdoğan needs to rise above a majoritarian understanding of democracy and do justice to the aspirations of a public that heeded his call by pouring into the streets and squares to defeat the coup attempt.

Clearly, Turkey’s democracy has taken a severe blow—cushioned only by the unequivocal stance of the opposition leaders and the media against the coup. Once again, the nation managed to break this pattern of ten-year coups. This offers the country a matchless opportunity for reconciliation. Granted, Erdoğan has had an exceptionally rough weekend and his frustration with those responsible for or implicated in the coup is understandable. He is correct in calling “for their punishment under the full force of the law of the land.” It will, however, now be critical that he ensure that the rule of law is upheld and rises to the challenge of winning the hearts and minds across a deeply polarized nation. He has the tools for it in his repertoire and had successfully wielded them in the past—especially between 2003 and 2011, when he served as prime minister. In hindsight, this period is often referred to as AKP’s “golden age,” when the economy boomed, democracy excelled, and Turkey was touted as a model for those Muslim-majority countries aspiring to transform themselves into liberal democracies.

As he steers the country from the brink of civil war, Erdoğan needs to rise above a majoritarian understanding of democracy and do justice to the aspirations of a public that heeded his call by pouring into the streets and squares to defeat the coup attempt. This is the least that the Turkish public deserves. This would also be a move in the right direction for Turkey’s neighborhood, which desperately needs a respite from the turmoil resulting from the war in Syria, the instability in Iraq, Russia’s territorial ambitions and now Brexit. This is the moment when a stable, democratic, transparent, accountable and prosperous Turkey needs to come to the fore on the world-stage. The United States needs it too. As much as the White House declared its faith in the strength of Turkey’s democracy and its support for the elected leadership, there is a clear chance for forging closer cooperation between the two countries. The first step in cooperation should be in bringing to justice the perpetrators of this coup, followed by measures to enhance Turkey’s capacity to address and manage the many challenges facing Turkey and its neighborhood.

Editor's Note: The current U.S. presidential race demonstrates the deep political divisions that exist in our country. But what does it mean to be "liberal" or "conservative," "Republican" or "Democratic"? According to Shadi Hamid, certain values transcend political chasms. This post originally appeared on PBS NewsHour.

What does it mean to say that the Republican Party is on the “right”? The GOP, long defined (at least in theory) by its faith in an unbridled free market, the politics of personal responsibility, and a sort of Christian traditionalism, is no longer easily plotted on the traditional left-right spectrum of American politics. Under the stewardship of presidential nominee Donald Trump, the Republican Party appears to be morphing into a European-style ethnonationalist party. With Trump’s open disrespect for minority rights and the Bill of Rights, the GOP can no longer be considered classically “liberal” (not to be confused with capital-L American Liberalism). This is a new kind of party, an explicitly illiberal party.

These developments, of course, further constrain Republicans’ appeal to minority voters (I haven’t yet met an American Muslim willing to admit they’re voting for Trump, but they apparently exist). This makes it all the more important to distinguish between conservative values and those of this latest iteration of the Republican Party.

There are some aspects of Burkean conservative thought – including aspects of what might be called civic communitarianism – that could plausibly strike a chord in the current cultural landscape across “left” and “right,” categories which, in any case, are no longer as clearly distinguishable as they once were. (Take, for example, British Labour leader Jeremy Corbyn’s Euroskepticism and that of his opponents on the right, or the populist anti-elitism and trade protectionism that are now the province of both Republicans and Democrats).

Everyone seems angry or distrustful of government institutions, which, even when they provide much needed redistributive fiscal stimulus and services, are still blamed for being incompetent, inefficient, or otherwise encouraging a kind of undignified dependency. After the Brexit debacle, it seemed odd that some of the most Europhobic parts of Britain were the very ones that benefited most from EU subsidies. But this assumes that people are fundamentally motivated by material considerations and that they vote – or should vote – according to their economic interests.

If there’s one thing that the rise of Trump and Brexit – and the apparent scrambling of left-right divides – demonstrates, it’s that other things may matter more, and that it’s not a matter of people being too stupid to realize what’s good for them. As Will Davies put it in one of the more astute post-Brexit essays, what many Brexiteers craved was “the dignity of being self-sufficient, not necessarily in a neoliberal sense, but certainly in a communal, familial and fraternal sense.”

The communitarian instinct – the recognition that meaning ultimately comes from local communities rather than happiness-maximizing individuals or bloated nanny-states – transcends the Republican-Democratic or the Labour-Conservative chasm. In other words, an avowedly redistributive state is fine, at least from the standpoint of the left, but that shouldn’t mean neglecting the importance of local control and autonomy, and finding ways, perhaps through federal incentives, to encourage things like “local investment trusts.”

Setting up local investment trusts, expanding the child tax credit, or introducing a progressive consumption tax aren’t exactly a call-to-arms, and various traditionalist and communitarian-minded philosophers have, as might be expected from philosophers, tended to stay at the level of abstraction (authors armed with more policy proposals are more likely to be young conservative reformers like Ross Douthat, Reihan Salam, and Yuval Levin). Douthat and Salam want to use wide-ranging tax reform to alter incentives in the hope of strengthening families and communities. This is a worthy goal, but realizing such policies requires leadership on the federal level from the very legislators who we should presumably become less dependent on.

This is the reformer’s dilemma, regardless of whether you’re on the left or right. If your objective is to weaken a centralized, overbearing state and encourage mediating or “middle” institutions, then you first need recourse to that same overbearing state, otherwise the proposed changes are unlikely to have any significant impact on the aggregate, national level.

The fact that few people seem interested in talking about any of this in our national debate (we instead seem endlessly intrigued by Melania Trump’s copy-and-paste speechwriting) suggests that we’re likely to be stuck for some time to come. Incidentally, however, the Hillary Clinton campaign slogan of “Stronger Together” has an interesting communitarian tinge to it. I doubt that was the intent, and it’s only in writing this column that I even took a minute to think about what the slogan might actually mean. I, as it happens, have been much more interested in talking about – and worrying about – an unusually fascinating and frightening man named Donald Trump.

Five years ago, my mother needed an orthopedic surgeon for a knee replacement. Unable to find any data, we went with an academic doctor that was recommended to us (she suffered surgical complications). Last month, we were again looking for an orthopedic surgeon- this time hoping that a steroid injection in her spine might allay the need for invasive back surgery. This time, thanks to a recent data dump from CMS, I was able to analyze some information about Medicare providers in her area and determine the most experienced doctor for the job.  Of 453 orthopedic surgeons in Maryland, only a handful had been paid by Medicare for the procedure more than 10 times.  The leading surgeon had done 263- as many as the next 10 combined. We figured he might be the best person to go to, and we were right- the procedure went like clockwork.

Had it been a month prior to the CMS data release, I wouldn’t have had the data at my fingertips. And I certainly wouldn’t have found the most experienced hand in less than 10 minutes.

It’s been a couple of month since the release of Medicare data by the Centers for Medicare and Medicaid (CMS) on the volume and cost of services billed by healthcare providers, and despite the whiff of scandal surrounding the highest paid providers (including the now-famous Florida ophthalmologist that received $21 million) the analyses so far have been somewhat unsurprising. This week, coinciding with the fifth Health DataPalooza, is a good time to take stock of the utility of this data, its limitations, and what the future may hold.

The millions of lines of data was exactly as advertised: charges and paid services under traditional Medicare “fee-for-service,” including the billing provider’s ID and the costs to Medicare. The initial headlines touting “Medicare Millionaires” relied on some basic arithmetic and some sorting.  And the cautions piled up: the data could reflect multiple providers billing under a single ID; payments are not the same as a provider’s actual take home income; it’s not complete information as it doesn’t contain information about other insurers, or even Medicare Advantage, and so on.

But perhaps most damning was how little insight the data seemed to provide on the quality or value of care provided, as opposed to volume of services.  As Lisa Rosenbaum wrote in the New Yorker, “So much of that good isn’t captured by these numbers. You don’t bill for talking to a patient about how he wants to die. There’s no code for providing reassurance rather than ordering a test.”

Where is the value in the data?

Data bear witness to the fundamental flaw of the payment system that generates them. The absence of information on quality, safety, appropriateness, or outcomes appears to have been a genuine revelation to many, but it is in fact exactly the type of output that we should expect from this volume-based system that we have built. This is not a critique of the data release. It is an indictment of our payment system.

Data is revealing important trends in how we pay doctors differently. Not all physician payments are created equal, and the data certainly shows the disparities across specialties, primary care, and others. For example, the average total annual Medicare payment to geriatricians was less than $100,000, while dermatologists and radiation oncologists (who presumably also see non-elderly patients) received on average $200,000 and $360,000 respectively. The important question will be why and should it continue?

Figure 1: Distribution of Total Medicare Pay by Provider Type, 2012 

Source: Author's calculations based on Medicare data released in April 2014

Data is revealing important indicators of cost and pricing – a major contributor to rising health care costs. Why is it that a brief visit with a geriatrician is worth $13; a 45-minute visit with a geriatrician sorting through medications, educating family members, and developing a quality of life plan with a terminal cancer patient is worth $79; and a dermatologist treating suspected skin cancer can earn upwards of $600 for a procedure that takes them minutes?

Data sheds light on practice patterns. The data is also revealing important variances in utilization of drugs and treatments. For example, a block apart on Park Avenue, two ophalmologists differ significantly in their use of treatments for macular degeneration. One uses expensive injectable drugs and gets paid over $10,000 per injection, while the other receives less than $500 for the lower-cost equivalent.

A CBS News report looked at spinal fusion surgeries—a procedure where there is almost no evidence demonstrating a net benefit to patients compared to other conservative therapies. They observed that “while the average spine surgeon performed them on 7 percent of patients they saw, some did so on 35 percent.”

At the extremes, outlier “practice pattern” begins to raise questions of potential improper billing or outright fraud and abuse. For example, simply looking at the frequency and volume of services provided to individual beneficiaries can identify concerning outliers. This laboratory company billed for 28,954 blood glucose reagent strips in 2012- for 88 patients. And yes, that’s highly unusual.

Figure 2: "Outlier" Medicare Billing for Blood Glucose Reagent Strips, 2012

Source: Author's calculations based on Medicare data released in April 2014

One clinical social worker billed for 1,697 separate days of service on 28 patients (the size of the bubble is proportional to the total amount of reimbursement by Medicare in 2012).

Figure 3: "Outlier" Medicare Billing for Days of Service, 2012

Source: Author's calculations based on Medicare data released in April 2014

The most extreme outlier, Dr. Gary Ordog, was named by NPR and ProPublica in their examination of providers who are outliers on their pattern of coding for the highest intensity office. Ordog had previously lost the right to bill California’s state Medicaid program, and yet continued to charge Medicare for over $500,000 in billing in 2012. It’s important to caution however, that even in these extreme outliers, statistics alone cannot provide definitive evidence of abuse. There is a need for formal investigation.

Medicare and law enforcement officials will need to create new processes for dealing with a potential flood of outlier reports from amateur sleuths like me.

What's Next for Medicare Data?

Data can be trended. Updates of data releases can begin to show us not just snapshots, but moving pictures of our healthcare system as it undergoes rapid changes. The New York Times reported on the increase in charges for certain frequent causes of hospitalization between 2011 and 2012. It will be interesting to see whether the data release itself, and the Steven Brill landmark Time article on hospital charges, have an impact on reversing these trends.  

Data can be “mashed up”.  The value of open data is hugely greater than the sum of its parts. As more and more data becomes available, the files can be cross-linked and “mashed up” to be able to answer questions no one database could have.  ProPublica linked together cobbled together data on state actions and sanctions on physicians with the Medicare data release to ask why these physicians are still being paid by Medicare.

What does the future hold? Correlations with drug prescribing data, meaningful use, and referral patterns are possible today, Sunshine Act disclosures and quality reporting, and much more is soon to come.

As we get comfortable with the data, analysts can move past the basics of arithmetic and sorting, we have an opportunity to make more ‘meaningful use’ of this data. We can begin to identify practice patterns, overuse, variations in geography or demographics, and potentially even fraud and abuse. As more and more data becomes available, the files can be cross-linked and “mashed up” to be able to answer questions no one database could have addressed. What will determine the value of the Medicare data release will be the creativity of those data scientists, epidemiologists, and health services researchers (amateur as well as professional) who can ask the challenging questions that must be answered.

Although advancements in medical science have greatly improved overall life expectancy and the ability for many to survive a cancer diagnosis, a recent study predicts that cancer care alone will cost the American health system $157 billion by 2020. It is well known that a major driver of these surmounting costs is the rising cost of chemotherapy and other treatments, in addition to the variation in how these treatments are used across the health care system.  However, there are several ways that providers, payers, and patients can work together to establish a more medically and financially effective cancer care model that also reduce costs and inefficiencies in the system.

Figure 1: Estimates of the national expenditures for cancer care in 2010 and estimated increase in cost in 2020

Source: Journal of the National Cancer Institute

Develop “Clinical Pathways” to Reduce Inappropriate Use
For many cancers, there are multiple drugs that can be equally effective in treating a patient’s condition, but the price of these treatments can differ in cost by tens of thousands of dollars. Currently, oncologists are responsible for purchasing their own chemotherapy drugs, processing and maintaining them in a specialized pharmacy-like set up, and then administering them to their patients. Insurers then reimburse the oncologists for the cost of the drugs plus a margin to defray the price of maintenance and administration. Since oncologists receive a share of their income from the margins on the drugs they prescribe, insurers assert that there is an incentive to prescribe the pricier drugs, even when lower cost options of equal effectiveness exist.

One mechanism for ensuring that the most evidence-based treatment is used in the care of cancer patients is to use a set of “clinical pathways.” These pathways are based on clinical guidelines available to the public, but tailored for a particular set of patients or a type of oncology practice. Many professional societies have contributed to these guidelines and are working on developing more advanced tools to manage a patient’s care. The American Society of Clinical Oncology (ASCO) is developing a system to rate drugs for advanced cancer based on a combination of benefit, side effects and price.

Several health plans and providers are already showing results. A Pennsylvania-based collaboration with the University of Pittsburgh Medical Center and commercial payers achieved savings of more than $1 million in only six months by controlling and reducing the use of Avastin through clinical pathways. A Washington-based health plan also achieved $1 million in cost savings through a partnership with 22 medical oncologists.[i] Most recently, one of the nation’s largest health plans announced a new clinical pathways program that provides oncologists with $350 per patient per month (PMPM) for adhering to specific chemotherapy regimens. The program will be rolled out in July across six states with potential for expansion after its first year.

Develop Appropriate Value-Based Incentives that Improve Care and Reduce Costs
It will also be essential to develop alternative payment models that move away from a volume-based fee-for-service model that only pay oncology practices for traditional face-to-face office visits and parenteral medications. Instead, payers should support the transition to value-based models that reward non-traditional care, such as telephone and e-mail clinician support, patient education, and counseling services with a social worker.

ASCO also released a comprehensive payment reform proposal to transition to an episode-based payment system. The proposal outlines five types of flexible, bundled payments built around (1) taking on new patients; (2) providing treatment during a given month; (3) actively monitoring patients when they are not being actively treated; (4) the progression or recurrence of a patient’s disease that requires significant treatment regimen changes; and (5) a patient’s participation in a clinical trial. Additional recommendations include adding penalties or bonuses of up to 10 percent based on the quality of care provided, and complementing other payment reforms such as primary care medical homes and accountable care organizations (ACOs). A number of potential methods of reforming the oncology payment system have been explored elsewhere, including implementation of the Community Oncology Alliance (COA) Oncology Medical Home.

Replicate value-based models across the private and public sectors. Even with momentum from private insurers, comprehensive change must involve the public sector. When Medicare, the largest health insurer in the country, changes policies, many commercial insurance companies follow suit. Cancer care would be an ideal arena to launch a program like Medicare’s Comprehensive Primary Care Initiative, a multi-payer public sector-private sector collaboration to strengthen primary care.

In many ways, insurers’ decisions to take direct action to minimize variations in care and excessive costs sets the stage for what is to come next in health care reform. Not only does this represent a step toward broad payment reform in oncology, but marks a trend toward exploring new methods of payment in other specialties, and to align those efforts with primary care payment reforms.

To learn more about the Engelberg Center's efforts to reform payment in the field of oncology, join us on July 9th from 10:30 AM to 12:30 PM EST for MEDTalk: Reinventing Patient-Centered Cancer Care.

There are now more than 335 Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP) in 47 states, DC, and Puerto Rico. Early results show that most Medicare ACOs are succeeding at meeting their quality benchmarks, but only about a quarter of MSSP participants have been able to reduce their spending enough below projected financial targets to qualify for shared savings. While these results are encouraging, especially given the financial and practice transformation necessary to succeed as an ACO, they also suggest that more work is needed from both CMS and the providers to ensure continued sustainability of the MSSP ACOs.

Given that the first three year cycle of MSSP ends in 2015 and more providers will likely be entering the MSSP in the coming years , the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) that will establish the rule for participation in the Medicare ACO program. In anticipation of these coming changes, the Engelberg Center for Health Care Reform released an issue brief that identifies the "Top Eight ACO Challenges" to encourage further discussion and considerations for ensuring the continued success of ACOs. These potential policy alternatives build on discussions with ACO Learning Network members and other related stakeholders implementing accountable care across the country and include the following issues.

These issues, and many others, will be a focus of the discussions at the upcoming Fifth National ACO Summit later this week.

Top Eight Medicare ACO Challenges

1. Make Technical Adjustments to Benchmarks and Payments
In order for ACOs to qualify for shared savings, they must be able to hold spending below a financial benchmark set using historical spending patterns and meet a certain threshold of person and population-level quality metrics. A number of issues should be considered that affect the ACO’s chances of being able to attain shared savings and have more predictability about their performance: benchmark calculation methodology, how to adjust for regional variation in performance, and risk adjustment.

2. Transition to More Person-Based Payments
The ultimate goal of an ACO is to improve quality at the patient and population level and control the growth of health care costs. In order to successfully achieve this mission, ACOs must over time make a transition to payments that involve the assumption of more risk by the provider organization with a reward for better health outcomes for groups of patients. ACOs must have a clear transition path for increasing accountability and assumption of more risk for patient health outcomes.

3. Increase Beneficiary Engagement
Patients can play a critical role in helping to achieve the goals of an ACO. Health outcomes are determined by whether patients follow prescribed therapies. Increasing beneficiary engagement holds the potential to make patients more activated members of the ACO who can contribute to its success. A number of issues should be considered to improve beneficiary engagement, including adjusting attribution methods, creating more incentives for patients to seek care within the ACO, and finding opportunities to activate patients as part of the care team.

4. Enhance and Improve Alignment of Performance Measures
A central tenet of Medicare ACOs is delivering high quality health care as determined by performance on 33 measures established by CMS. ACOs must meet performance benchmarks in order to be eligible for shared savings, ensuring that these organizations are delivering high value, rather than simply cheaper, care. A number of barriers exist to achieving better performance measurement, including administrative burdens, lack of measure alignment among payers, lack of rewards for quality improvement, and concerns about measure selection.

5. Enable Better and More Consistent Supporting Data
In order to succeed as an ACO, organizations must be able to effectively collect, interpret, and use clinical and claims data to transform care of their patients. ACOs need to adopt new health IT systems and other technologies in order to collect and use the growing amount of data. ACOs currently struggle with reconciling data between different sources, dealing with patients who opt out of data sharing, lack of timeliness for receiving data, difficulty of tracking patients through the health system, and delays in performance feedback.

6. Link to Additional Value-Based Payment Reforms
ACOs are just one of many payment reforms that health care organizations across the country are implementing to improve quality and reduce costs. Aligning the vision and components of these other initiatives with ACO reforms has the potential to reinforce the shared goals and fundamentally change the health system. However, there are barriers to achieving this alignment such as lacks of linkages to bundled payments and other new payment models, multi-payer ACOs with different payment systems, and inability for organizations to participate in multiple CMS payment innovations.

7. Develop Bonus Payments and Other Incentives to Participate
In order to effectively transform clinical practice, ACOs must create or procure significant financial and human capital, as well as transform their information technology and delivery infrastructure. A recent survey estimates the average start-up cost for creating an ACO to be $2 million, with some ACOs investing significantly more in their first few years. Many ACOs, especially smaller ones, struggle to find sufficient start-up capital, are uncertain if they can assume the level of risk required for an ACO, and need significant staff and clinical change to effectively transform care.

8. Support Clinical Transformation
Becoming and succeeding as an ACO is a vast undertaking that requires immediately beginning to transform practice, finance, and operations. However, many providers, particularly those that are less experienced at systemic practice transformation, need more support in undertaking clinical transformation.

Downloads

• Issue Brief: Improving the Medicare ACO Program

Contributors: Alice M. Rivlin and Christine Dang-Vu

Recent data suggest that Accountable Care Organizations (ACOs) are improving important aspects of care and some are achieving early cost savings, but there is a long way to go. Not all ACOs will be successful at meeting the quality and cost aims of accountable care. The private sector has to date allowed more flexibility in terms of varying risk arrangements—there are now over 250 accountable care arrangements with private payers in all parts of the country—with notable success in some cases, particularly in ACOs that have been able to move farther away from fee-for-service payments. Future growth of the Medicare ACO program will depend on providers having the incentives to become an ACO and the flexibility to assume different levels of risk, ranging from exclusively upside arrangements to partial or fully capitated payment models.

Given that the first three year cycle of Medicare ACOs ends in 2015 and more providers will be entering accountable care in the coming years, the Centers for Medicare and Medicaid Services (CMS) has indicated that they intend to release a Notice of Proposed Rulemaking (NPRM) affecting the Medicare ACO program.

In anticipation of these coming changes, the Engelberg Center for Health Care Reform has identified the "Top Eight ACO Challenges" that warrant further discussion and considerations for ensuring the continued success of ACOs across the country. To support that discussion, we also present some potential alternatives to current Medicare policies that address these concerns. These findings build on the experiences of the Engelberg Center’s ACO Learning Network members and other stakeholders implementing accountable care across the country.  In some cases, the alternatives might have short-term costs, but could also improve the predictability and feasibility of Medicare ACOs, potentially leading to bigger impacts on improving care and reducing costs over time.  In other cases, the alternatives could lead to more savings even in the short term. In every case, thoughtful discussion and debate about these issues will help lead to a more effective Medicare ACO program.

Top Eight ACO Challenges

1. Make technical adjustments to benchmarks and payments
2. Transition to more person-based payments
3. Increase beneficiary engagement
4. Enhance and improve alignment of performance measures
5. Enable better and more consistent supporting data
6. Link to additional value-based payment reforms
7. Develop bonus payments and other incentives to participate
8. Support clinical transformation

Downloads

• Issue Brief: Improving the Medicare ACO Program

A recent blog suggested that CMS’ efforts to standardize assessment data was based on a goal of “….creating a functional measurement tool that could be used throughout the industry.” In fact, CMS has been working since 2005 to meet the Congressional directive to standardize assessment information at hospital discharge, and post-acute care (PAC) admission and discharge for payment and quality reporting purposes (Deficit Reduction Act of 2005). The CARE tool was developed as part of the national Post-Acute Care Payment Reform Demonstration (PAC PRD). The conceptual domains and items were selected with the input of the wide range of stakeholder communities working with PAC populations. Clinicians from acute hospitals and each of the four PAC settings, including long term care hospitals (LTCHs), inpatient rehabilitation facilities (IRFs), skilled nursing facilities (SNFs), and home health agencies (HHAs) identified items to test in four areas: medical status, functional status, cognitive status, and some social support factors. Input was given by physicians, nurses, physical therapists, occupational therapists, speech and language pathologists, social workers and case managers working in each of the different levels of care. Initial item selection was based on a review of existing assessment items, including those in the three Federally-mandated instruments, (the IRF-PAI, MDS 2.0, and OASIS-B which were in effect at this time) and the input of each of the scientific communities working in these areas.

Developers of proprietary systems such as the UDS-MR©, Inter-RAI ©, and AM-PAC ©, as well as public domain items tested in clinical trials such as the PROMIS items, were all reviewed as part of this process. The selected items needed to be in the public domain so the measures could be modified as science advanced practice.

Over 200 providers participated nationwide to submit over 53,000 CARE assessments over the course of the PAC PRD. Participating clinicians also provided feedback during training and exit interviews. In general, positive feedback was provided on most items. Feedback showed that almost all items were commonly collected on existing instruments in hospitals and PAC providers, although some of the information may have been informally noted in charts rather than provided in the structured form of the CARE items.

The items were tested for reliability so they could be applied consistently across populations and settings. Most of the items were previously tested and found reliable in at least one of the five levels of care. Two types of reliability tests were conducted on the final CARE tool item set used in the PAC PRD. The results showed that most items when applied to the other four settings were at least as reliable as the existing Federal assessment items (Kappa scores of 0.6 or better) ensuring their reliable use in future quality measures or payment models would reach consistent results. Complete reports on item reliability and PAC PRD results can be found here.

Data standardization is critical to allow providers to exchange information as they follow the patient. The Deficit Reduction Act of 2005 directed CMS to use standardized assessment items at acute hospital discharge and PAC admission and discharge to allow for empirical comparisons of key questions arising out of changing incentives in the Medicare payment policies. The standardized CARE items are consensus-based versions of the items already collected by clinicians. These and additional items being incorporated into CMS’ assessment item library represent the “best in class.” The team developing the CARE item set represented the leading experts in each of the areas – Dr. Margaret Stineman of the University of Pennsylvania, developer of the function-related groups associated with the proprietary FIM©, Dr. Deborah Saliba, UCLA, lead developer of the MDS 3.0, and Dr. Chris Murtaugh of the Visiting Nurse Service of New York. Team members included Drs. Anne Deutsch and Trudy Mallinson of the Rehabilitation Institute of Chicago. Input was also given by Dr. David Hittle, of the University of Colorado who has worked closely with the OASIS tool, Dr. Samuel Markello, formerly of the UDS-MR©, and Dr. Patrick Murray of Case Western University.

The blog suggested that, “the early reviews of the CARE tool have been poor.” While this clearly is not true, it is worth pointing out that the author owns one of the key proprietary assessment instruments. The CARE items have been evaluated for reliability and they meet the national standards; they allow providers and others the opportunity to download the e-specification of the items without charge and to have the clinicians trained for free under CMS’ regular assessment training initiatives. CMS is currently developing quality measures using the “best in class” assessment items which all meet scientific standards. The quality measure development process already requires CMS to submit measures for endorsement by the National Quality Forum. The “loophole” identified by the UDS-MR© author is non-existent. The Measures Application Partnership is part of the existing NQF process included in the IMPACT legislation. Further, use of uniform data elements across settings, such as those used in the currently collected pressure ulcer measure, allows for exchangeability and improves communication across the system, finally creating a “data follows the person” system.

Editor’s note: This post is adapted from a forthcoming full-length case study; the second in a series from the Engelberg Center’s Merkin Initiative on Physician Payment Reform and Clinical Leadership designed to support clinician leadership of health care delivery, payment, and financing reform. The case study will be presented during the Merkin Initiative’s “MEDTalk” event on July 9 from 10:30 AM to 12:30 PM EDT, featuring live story-telling and knowledge-sharing from patients, providers, and policymakers.

Oncology practices and hospitals across the nation struggle with providing sustainable, comprehensive, and coordinated cancer care. Clinical leaders with strategies and models to improve the quality and value of health care often don’t know how to navigate the landscape of payment and delivery reform options to sustain their innovations.

We use a case study approach to investigate and tell the story of the New Mexico Cancer Center (NMCC), an independent cancer center that is experimenting with innovative ways to improve patient-centered oncology care. We identify challenges for creating sustainable and supportive payments models, and we share the broader strategic and policy lessons for adopting alternative payment models.

The Clinical Scenario: Living With Cancer

Vicky Bolton, a 58-year-old full-time medical legal coordinator from Albuquerque, has stage 4 adenocarcinoma lung cancer. She started chemotherapy in 2003 and has consistently received treatments over the last 11 years. Vicky is one of 13 million Americans currently living with cancer, with more than 1.6 million new diagnoses added each year.

Although Vicky’s condition is currently stable, she is at high risk for venous thrombosis (blood clots), life-threatening infections, and other complications, which put her at high risk for repeated hospitalizations. In the past six months, she has taken advantage of “after hours” care on three occasions as an outpatient at NMCC. Fortunately, each of her providers and services — oncology, radiation therapy, labs, x-rays, and internal medicine — are centralized in a single location at NMCC, reducing the need for emergency room (ER) visits or hospitalizations for these episodes.

The Challenge: Controlling Spending While Improving Patient-Centered Care

Cancer is the second leading cause of death in the U.S. Forty-one percent of Americans will be diagnosed with cancer during their lives. Cancer care is also expensive, accounting for $125 billion of total health care spending annually. In 2011, Medicare alone spent nearly $35 billion in fee-for-service (FFS) payments for cancer care, representing 9 percent of all Medicare FFS payments.

The high costs of cancer care are driven by issues that plague the entire health system: uncoordinated care delivery, duplication of services, fragmentation, and volume-based payments. A common impact of these drivers in oncology is the use of the ER to relieve symptoms associated with adverse effects of chemotherapy or other treatments that can also result in hospitalization.

For example, research shows that the most common reasons for cancer patient ER admissions are pain, respiratory distress, nausea, and vomiting. More than half of the ER visits occurred on weekends or in the evening, and over 60 percent resulted in hospital admission. This suggests that if a patient’s symptoms could be managed at home or in the community, costly hospital admissions could be avoided. ER visits, where patients are exposed to germs and infections as they wait — often hours — to be admitted, can have catastrophic outcomes for patients that are actively in treatment since they have weakened immune systems and are more prone to infections.

In addition to the inherent issues with fee-for-service (FFS) payments — with payments incentivizing volume of procedures rather than the value of care delivered — the current payment system further exacerbates problems: If a practice provides higher-value care to patients at a lower cost to the overall system (that is, they perform fewer services and have lower revenue), the financial winner is the payer who reimburses fewer services, not the practice (which merely has less revenue). This combination of the misaligned incentives of FFS and the lack of financial benefit for improving care while reducing costs means that many practices simply cannot afford to make the transformations needed without other funding mechanisms.

The Real World: How Has An Independent Cancer Center Responded To These Challenges?

NMCC delivers care to roughly 2,700 patients and provides care to one in three New Mexicans with cancer. The changes that the center has made have focused on reducing the impact of fragmentation of care on their patients (Table 1).

A key innovation was enhancing comprehensive after-hours and weekend care on site and creating a telephone and urgent care triage program to avoid expensive emergency room and inpatient care, which NMCC termed the COME HOME model.

As part of its redesign process in 2012, NMCC – along with six community oncology practices — secured a $20 million Center for Medicare and Medicaid Innovation (CMMI) Health Care Innovation Award (HCIA), for a three-year period. The award has an explicit aim of reducing ER visits by 50 percent and hospitalizations by 20 percent to justify the program costs.

Table 1: Care Redesign Elements Undertaken by NMCC

The Key Levers: How Can COME HOME Be Sustained?

On the heels of the Affordable Care Act (ACA) and numerous quality and payment focused initiatives in the private sector, health care organizations need to enhance the competitiveness and efficiency of their systems in the marketplace.

Alternative payment models (APMs) such as Accountable Care Organizations (ACOs), bundled payments, and patient-centered oncology medical homes (PCOMH) are just a few of the initiatives supported by public and private payers to align care redesign and payment reform and encourage continuous improvement. (Clinical pathways, a strategy recently embraced by WellPoint, offer PCOMH-like incentives to encourage adherence to practice guidelines, a strategy primarily geared to encourage higher-value chemotherapy practice.)

Broader or larger case-based payments may also provide stronger incentives to limit costs, to help assure that promising delivery reforms actually lead to cost reduction, but this exposes oncologists to greater levels of financial risk, as shown in Table 2. Consequently, implementing payment reforms that are viewed as feasible and desirable by both providers and payers is difficult.

Table 2: Comparison of Alternative Payment Models for Oncology

The Path Ahead: How Can These Models Assist NMCC?

NMCC currently receives approximately $70,000 per month from the CMMI grant and has not yet identified a clear strategy to sustain the delivery reforms in the COME HOME care model past the end of the grant (July 2015). As for payment reform options, NMCC has been unable to contract as part of a comprehensive ACO due to local health care market conditions.

Clinical pathways are geared primarily to guidelines and chemotherapy adherence, and are not designed to provide funding for after-hours care or triage programs that are intended to achieve offsetting savings through avoiding costly complications. Possible remaining options include:

• PCOMH: Using the data it gathers, NMCC intends to quantify the additional costs the COME HOME model requires, and the savings that it achieves. Based on that estimate, NMCC could suggest a per-member per-month (PMPM) payment from a private insurer to cover the costs of providing higher quality care. To encourage participation, NMCC could also enter into a risk-sharing agreement, in which overall costs of inpatient care and ER visits would be compared against a target. The PMPM payment could be at-risk if the targets are not achieved after a certain period of time.

• Bundled Payments: NMCC could potentially use the medical home approach with risk sharing (described above) as a first, interim step toward a bundled payment system, NMCC’s long-term preferred model. Computing actuarially sound expected costs for the bundled payments would require merging claims data with clinical data (for example, ICD-9 codes fail to distinguish between subtypes of breast cancer that have radically different treatments). A bundled payment pilot might be performed for high volume cancers, such as breast and lung.

Lessons Learned

The experience of innovative pioneers like NMCC can shed some light on potential barriers to conceptualizing and implementing sustainable clinical redesign. The lessons learned have been sorted into three main categories: relationships with payers and networks, payment model selection, and data collection and quality improvement considerations.

Relationships with payers and networks. Though counterintuitive, merely demonstrating significant value from care design, perhaps from lower utilization of inpatient and emergency department utilization, does not automatically create a financial pathway for sustainable delivery reform. To do so, innovative providers should consider involving lead payer partners early on to help identify end-points of interest to payers and potential payment strategies that may emerge later.

Providing support for health care delivery reforms requires new activities by payers towards aligning their payments with value, rather than volume and intensity of services. However, fragmented health care markets face the challenge of the “free rider” problem: payers may be unwilling to shoulder delivery transformation costs that may benefit other payers’ clients while they wait for CMS or others to make the financial investment, pay for the program evaluation, and enact policy change). Other challenges include payer inertia and long lag times between care redesign and subsequent data demonstrating results.

Large ACOs and other integrated payer-provider plans, including those large enough to form Medicare Advantage plans, are moving forward on negotiating payment and delivery reforms. This may be more difficult for innovative, smaller practices, even if they can provide higher-value clinical services. In turn, this may have anti-competitive consequences, such as discouraging delivery innovation that leads to “demand destruction” of high-cost hospital-based services. Private and public payers should be particularly interested in developing models that enable smaller, specialized providers like oncology practices to undertake key delivery reforms.

Sustainable Payment Model Selection. While substantial attention has been paid to primary care focused APMs, specialty-focused APMs are needed for practices like NMCC. Their development should be a high priority for public and private payers. Clinical transformation grants, such as those offered by CMMI, should include clear pathways for transitioning to APMs if initial cost savings targets or projections are met. Otherwise, delivery system innovations are at high risk of failure despite evidence of improved value.

Data Collection and Quality Improvement Considerations. Timely sharing of actionable information from claims and other administrative data remains a major challenge, with complex and varied procedures for obtaining claims from payers; smaller practices are particularly challenged in interpreting the claims data. Some states, such as Maryland, Massachusetts, Vermont, and Colorado (among others) are proceeding with creating all-payer claims databases. (Maryland, for example, offers almost instantaneous provider feedback from claims through their CRISP database.)

Others, such as Minnesota, are using “distributed” approaches in which multiple payers and systems produce measures in consistent ways. As NMCC’s early efforts illustrate, practices can produce more clinically sophisticated performance measures. Strategies to achieve consistent methods for sharing key data on cost and quality need to be expanded to encourage quality improvement and payment reform.

Event Information

Many clinicians have terrific ideas for improving the quality and cost of health care, but often don’t know how to navigate the often baffling landscape of payment and delivery reform options. To address this need in clear, practical terms, we are pleased to announce the second MEDTalk event in the “Merkin Series on Innovations in Care Delivery.” The series is designed to support clinicians and policymakers who’ve always wondered how delivery reform occurs, but didn’t know where to begin. 

Our second case focused on the work of leaders from the New Mexico Cancer Center (NMCC), and their efforts to "Reinvent Patient-Centered Cancer Care." The event featured several brief “TED-style” talks that considered the challenges of delivering oncology care, while enhancing patient experience, improving coordination of care, and reducing costs. The agenda included firsthand experiences from patients, payers, policymakers, and NMCC's clinical leadership who explores sustainable improvement strategies, and the financial mechanisms available to encourage innovations in oncology.

Video

• A Day in the Life: The Patient Experience
• The Future of Oncology: Drugs, Genetic Testing and Personalized Medicine
• The Challenge of Delivering Cancer Care in a Triple Aim World
• What We're Learning from New Oncology Payment Models
• Supporting Care While Reducing Costs: What is Possible?
• The New Mexico Experience: Aligning Clinical Redesign and Payment Reform
• Sustaining Improvements in Patient-Centered Care
• Lessons Learned and the Path Forward
• MEDTalk: Reinventing Patient-Centered Cancer Care

Event Materials

• Oncology Case Study August 2014 FINAL WEB

Payment reform in health care is confusing, but the goal is simple: How can health care providers change their economic incentives to encourage value over volume? If you've wondered about how these new payment models work, we’re here to help. And if you want to see Dr. Patrick Conway, the head of the Center for Medicare and Medicaid Innovation, talk about it more in depth at our most recent MEDTalk event about oncology care reform, click here.

Where are we now?

Fee-for-Service. Traditionally, health care providers are paid in a "Fee-for-Service" (FFS) model. This is exactly what it sounds like: every time you have a blood test, a doctor's visit, a CT scan, or any other service, you (and your insurance company) pay separately for what you have received. Over the course of a long treatment or a chronic condition, that can add up to a huge expense.

The Fee-For-Service System

It is well known that FFS is draining the entire health care system. When paying for volume, a sick patient is worth more than a healthy patient , and this status quo results in uncoordinated care, duplication of services, and fragmentation. After all, the more doctors and providers do, the more they get paid.

Reformers hope to replace the traditional FFS model with something better, and they’ve come up with many different models of payment that could allow this to happen. (Note to reader:  these are simplified explanations; policy enthusiasts can learn much more about them through the Engelberg Center’s Merkin Initiative).

Here are four widely proposed and increasingly popular alternative payment models:

Accountable Care Organizations (ACOs) are groups of providers across different settings– primary care, specialty physicians, hospitals, clinics, and others – who chose to come together to jointly share responsibility for overall quality, cost, and care for a large patient population. These providers recognize that poorly coordinated care from these entities can lead to increased costs from things like redundant tests and overlapping care.

Accountable Care Organization Model

Here’s how it works in basic terms: the ACO physicians bill the way they always do, but the total costs get compared to an overall target. Plus, they have to measure some of their patient outcomes, to prove that they hit certain quality benchmarks. If costs are higher than the target, the ACO may get penalized. In the end, if they are under the cost target and satisfy their quality measures, they get a share of the savings.

By bringing all of these providers under the umbrella of an ACO, caregivers can all be on the same page, and the patients ideally receive coordinated care with a focus on prevention – since providers are encouraged to keep their patients healthy and not just earn more by doing more tests and procedures.

Bundles: A health care bundle estimates the total cost of all of the services a patient would receive per episode over a set time period for a certain problem, like a knee replacement or heart surgery. For example, a payer such as Medicare or an insurance company could calculate that a hypothetical 30-day bundle for a knee replacement surgery costs $10,000.

Without Bundled Payment...

The payer reduces the total cost of the episode by 2-3%, and hands the bundle over to the provider – in the knee surgery example, that becomes $10,000 minus 2%, so $9,800. The provider is then responsible for all costs of treatment – whether or not it exceeds the amount of money they were originally given. This encourages the provider (collaborating with the entire care team) to help the patient avoid preventable complications like a hospital readmission by better managing a patient’s care.

With a Bundled Payment...

If the provider keeps costs low, they can keep the margin on the bundle, while the insurance company already saved by reducing the cost of the episode by a small percentage when they created the bundle. So, in our example, if the provider was able to meet quality benchmarks and the total cost of the 30-day episode was $9,000, they get to keep the extra $800.

Patient-Centered Medical Homes set themselves apart by providing set monthly payments on top of existing funding models, in order to fund a highly coordinated team of primary care professionals, which may include, depending on the patient’s needs, physicians, nurse practitioners, medical assistants, nutritionists, psychologists, and possibly even specialists. The team works closely to build a strong relationship with each other,with their patients and their caregivers.

Patient-Centered Medical Home Model...

This extra money can be used to hire nurses or agencies to give special care and attention (by phone or home visits, for example) to high-risk patients, with the goals of reducing emergency room visits and other preventable problems in the long run. Other enhancements might include email communication with patients, more time to call and coordinate care between primary care doctors and specialists, and so on. In the end, the savings from better coordinated care make the extra monthly payments worthwhile.

Pathways, an idea which has gained traction in oncology care, provides a system of choices and decision making tools for providers and patients in order to prescribe the most effective and least costly treatment. For example, let’s say there are two cancer drugs proven to have the same effectiveness, with no differentiation in side effects, but one of them costs less than the other.

Same Effectiveness, Different Cost...

Like the medical home, the pathways model uses a “per-patient” add on fee (often much larger than for medical homes focused on primary care, since cancer patients need intensive treatment) that might encourage the provider to prescribe the less expensive of two equally effective treatments.

How Pathways Creat Savings...

When this is implemented on a broad scale, the savings could add up for payers, and defray the cost of the add-on fees.

Please feel free to use any of these images in your own work, presentations, or educational efforts, and to view and download the interactive versions here.  The images should be attributed to The Merkin Initiative on Clinical Leadership and Payment Reform at Brookings.

Please note that this Engelberg Center for Health Care Reform Health Policy Issue Brief first appeared in the Health Affairs Blog on July 31, 2014. Click here for the Health Affairs Blog version.

Abstract

Individual patient expanded access is a process by which patients can obtain investigational drugs that have not been approved by the Food and Drug Administration (FDA) outside of a clinical trial setting from biopharmaceutical companies when no other alternative therapy is available. Currently, no industry-wide structural principles exist to help companies navigate this process while balancing the needs of getting a drug to the market as quickly as possible with providing potentially life-saving treatment to individual patients. The Engelberg Center convened a stakeholder group to identify common themes and identify common principles related to expanded access, as none currently exist. The result was 4 A’s - Anticipation, Accessibility, Accountability, and Analysis – to help assist patients, providers, and companies with expanded access. Process and capacity building recommendations for the FDA also were proposed to assist companies with sustaining expanded access programs.

Call to Action: The Importance of Expanded Access Programs

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer. Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage. Such cases included 7-year-old Josh Hardy (brincidofovir from Chimerix for disseminated adenovirus infection), 45-year-old Andrea Sloan (BMN673 from BioMarin for ovarian cancer), 41-year-old Nick Auden (pembrolizumab from Merck for melanoma), and 6-year-old Jack Fowler (intrathecal idursulfase from Shire for Hunter Syndrome). Expanded access requests to the FDA for new patients are increasing, from 1,000 patients nationwide in 2010 to more than 1,200 in 2012.[i] (This is likely an underestimate, since it does not include appeals made directly to companies.)

In the wake of these events, it became clear that many biopharmaceutical companies had varying experiences and policies related to such access. From the domestic regulatory standpoint, the FDA revised its expanded access regulations in 2009, which define criteria that must be met to authorize expanded access, list requirements for expanded access submissions, describe safeguards that will protect patients, and preserve the ability to develop meaningful data about the use of the drug. Biopharmaceutical companies typically face a complex global environment in which legal and regulatory frameworks can differ substantially. At the meeting, a senior FDA representative indicated the agency has approved over 99 percent of expanded access requests submitted via single patient or emergency INDs since 2009, suggesting the regulatory agency is not a major barrier to expanded access. As such, provided the access request is reasonably related to the potential benefits of the drug, the biopharmaceutical company is almost solely responsible for the decision and liability regarding whether to grant expanded access to an individual. Still, the public belief persists that the FDA is the main bottleneck that restricts access. In April 2014, Representative Morgan Griffith (R-VA) proposed H.R. 4475, The Compassionate Freedom of Choice Act of 2014, designed to restrict the FDA’s ability to prevent the use of investigational drugs in terminally ill patients. Similarly, some states have passed “Right to Try” legislation to reduce FDA oversight, but contains no requirement that companies must make drugs available.[ii]

The goal of our meeting was to identify common themes and possibly broad outlines to suggest industry-wide policies related to expanded access, as none currently exist. The group first discussed background issues related to expanded access and agreed on definitions. The meeting then focused on three topics. First, the group participants who play key roles in evaluating expanded access requests were invited to share narrative experiences in specific clinical cases, in an effort to lay the groundwork for trust and open discussion. Second, the group was asked to identify internal industry-specific structural barriers, such as the existence of clear procedures or tracking mechanisms within companies to handle requests. Finally, the participants reflected on situations in which expanded access may not be appropriate, or where regulatory barriers or liability concerns may hinder expanded access. This paper reflects the authors’ observations and assessment of the internal and external landscape, based upon information provided by the meeting participants.

Laying the Groundwork with Shared Experiences

The FDA allows companies to provide drugs and charge individual patients that do not meet the enrollment criteria for clinical trials geared towards regulatory approval through expanded access programs.[iii] These programs are meant to provide the drug directly to treat the patient’s condition, rather than having the primary goal of collecting efficacy or detailed safety data in support of approval. Before 1987, the FDA lacked formal recognition of expanded access, although investigational drugs were provided informally.[iv] Since then, the FDA has instituted novel classes of individual INDs so that a company sponsor or licensed physician can legally obtain treatment access from the FDA to provide a drug while it is still in the approval process.[v] Essentially, this provides companies a legal exception from the law to ship unapproved drugs across state lines, and if they desire, to charge for them. These INDs are designed solely for the potential benefit of desperate patients and not intended to formally collect safety or efficacy data that could potentially inform a regulatory decision, but can have regulatory impact, nonetheless.

At the outset, several participants objected to the term “compassionate use,” since it introduces inherent value decisions, can emotionally charge discussions, and does not recognize that there may be valid and ethically appropriate reasons for denial. The generally agreed upon term “expanded access,” is used throughout this paper. (One participant suggested the term “early access.”) Ideally, the term would make it obvious that this is access to an unapproved drug, in order to temper expectations of favorable results. Somewhat confusingly, the FDA uses the terms “expanded access,” “access,” and “treatment use” interchangeably to refer to the use of a drug, and of which none clearly identify the stage of development.[vi]

Participants shared numerous examples of requests for expanded access and explained that their companies handle anywhere from a handful to several hundred requests per year. The following selected stories illustrate the wide range of experiences and situations that companies encounter when navigating the complex decisions involved in administering an expanded access program. Several other examples were discussed and the specific participants expressed that they would be willing to share these particular examples publicly.

Chimerix, a 54-employee company based in Durham, North Carolina, is developing the drug brincidofovir and previously had created an intermediate expanded access protocol for the drug (CMX001-350) as encouraged by the FDA following over 200 emergency INDs granted for access to brincidofovir.[vii] One such case was for an armed services member with previously undiagnosed acute myelogenous leukemia who developed life-threatening vaccinia infection following smallpox vaccination in 2009.[viii] The patient received the drug from Chimerix through an emergency IND. After two years, the company had not secured FDA approval for the drug and eliminated expanded access in February 2012 in order to focus on studies which would inform a regulatory decision. In March 2014, Chimerix originally rejected an emergency IND request for 7-year old, Josh Hardy, who was critically ill from disseminated adenovirus infection after bone marrow transplantation. A highly public social media campaign targeted the company in the wake of this decision, and the experience was traumatizing for many of the employees. Following discussion with the FDA, Chimerix initiated a new clinical trial for the treatment of adenovirus infection in order to collect safety and efficacy data to support an NDA submission. Hardy was the first patient enrolled in the clinical trial, and his family reported through several media outlets that he recovered from the adenovirus infection and was discharged home.

One biopharmaceutical company representative described receiving a middle-of-the-night telephone call directly at home, with an emergent, time-sensitive request for an experimental therapy for a critically ill child with a rare acute disease in a foreign pediatric intensive care unit, where regulatory standards were different from those in the U.S. The ideal pediatric dosage was unknown, and only limited safety data and clinical details were available. Urgent efforts were made to gather more information and the request was approved, but despite these efforts the patient did not survive.

Bristol-Myers Squibb began a clinical trial for a cancer drug several years ago.[ix] A woman with pancreatic cancer enrolled in the trial and saw that her tumor was no longer growing. After the 3.5 year trial, the study closed because the drug was deemed ineffective for all other patients and was not approved for further development. However, the company continued to provide the drug for the one woman for whom the drug was effective through a single patient IND for an additional 9 years.

To demonstrate the volume of expanded access requests, one participant showed several messages on his mobile device during the half-day discussion, directly from patients who had located his email addresses through on-line searches, to plead for expanded access to an anticancer therapy.

Development of Structural Principles: The Four A's 

Broadly, no specific industry-wide consensus on expanded access procedures exists. As a result, there is significant variation in company policies and procedures. During this phase of discussion, participants shared their own company strategies and suggested possible areas of consensus that might form the basis for shared principles and industry-wide practices. These suggestions fell into four categories, which we termed the 4 “A’s”: Anticipation, Accessibility, Accountability, and Analysis (see Figure 1).

First, the group agreed that large and small companies should anticipate the need for and creation of expanded access programs when developing drugs expected to generate expanded access requests and as part of the drug development plan. This is particularly important for drugs that might be considered for priority or breakthrough designation during FDA approval. In these cases, companies should strongly consider developing a written expanded use policy with clear guidelines for inclusion and exclusion, which would also feature a defined review process, clear decision making criteria, and a defined time frame for response to requests. This also allows companies to plan for the demands that may be placed on their supply chain and staff resources to ensure sufficient supply for investigational and expanded use purposes. Identifying a decision maker within each company and for each disease area/product will also help patients or physicians reach the appropriate contact when requesting a drug, as well as assist the company in gaining expertise in responding to these requests. For example, one large company identifies one point of contact for all expanded access requests regarding each product and posts that individual’s contact information on the website.

In the early stages of drug development, supplies of investigational drugs are extremely limited. This is often because the technically-challenging process of optimizing drug product manufacture takes a considerable amount of time. Low yielding manufacture batches are not uncommon at the early phases of research. Some companies do not approve expanded access requests because they do not have enough of the drug in stock to supply these external requests and meet the needs of investigational study patients and individuals participating in clinical trials, an issue which may be particularly acute for biologics. Smaller companies may have more resource constraints, such as inadequate staff to manage requests or supply chain and logistics issues. One representative suggested that if a company had early transparency from regulators about the final numbers of subjects they would be willing to accept to achieve drug development milestones, it would make it much easier for the company to feel less reservation about its drug supply. (It may be beneficial for companies to analyze their financial ability to provide drugs potentially at no cost or when there is not a large enough supply, ideally in a transparent manner.)

Once an expanded access policy is anticipated and developed, the second key principle the group identified was making the policy accessible to all individuals who may qualify. First, for patients, with guidance from their treating physician, the company making the drug should always steer the patient to enter a clinical trial (if they meet eligibility criteria). If the contacted company cannot accommodate the patient, they should steer them to other open trials if possible, even if sponsored by another company. Many of our participants noted that this already occurs.

The group was particularly cognizant of the disparity in access to drug companies and their expanded access programs: patients with savvy social media strategies are more likely to succeed in navigating across organizational constraints than without similar sophistication. The group believes that increased accessibility would assist in making opportunities for expanded access more equitable. In addition, these policies could help educate patients and physicians about submitting legitimate expanded access requests and help decrease the costs of reviewing inappropriate requests on the company (for example, if there are other proven therapies or the situation is not life threatening).

If the patient is ineligible for a trial, the patient should be able to easily access the written expanded access policy online. For example, both large and small companies like Pfizer, Bristol-Myers Squibb, Shire, and Merck post their expanded access policies on their websites, though the terminology may in some cases be complex. In addition, Janssen has developed a video explaining their policies in non-technical terms. Ideally, such policies should be available in some web based or public facing platform to both patients and physicians and written in a clear manner that is jargon free and accessible to individuals at various education levels. Most participants felt strongly that requests for expanded access should originate from a medical provider, not from a patient, since expertise is needed to first screen appropriate candidates. This is consistent with current FDA regulations for an IND, in which a physician or qualified medical expert must sponsor an IND or serve as an investigator under an existing IND for expanded access.

Third, companies should have accountability to the requesting party for expanded use requests that they receive and review them within a specified, transparent amount of time. If the request could not be approved, the company should consider clear communication and provide an explanation of why the request was turned down. In these cases, some participants suggested that the company might also consider instituting an appeals process by which a patient can receive an additional review if not approved, potentially from a non-binding third party such as an independent, multidisciplinary body or a regulatory agency like the FDA. (Two participants, however, were uncomfortable with any third party review.)

The final principle would encourage companies to release timely analysis of data from expanded access patients. In addition to tracking communication, companies should keep a database of the number of requests and outcomes, in a manner that doesn’t slow getting drugs to needy patients rapidly. One company refined its internal tracking tools to determine who was requesting drugs, for what conditions, and where they lived. Where possible, companies might be encouraged to share anecdotal or preliminary safety or efficacy data from expanded access in peer-reviewed or other refereed venues in a prudent time frame following collections, if this is available or known. This is not always possible, because emergency INDs do not require provision of safety or outcome data to the company.

There are several challenges associated with operationalizing this in the current model, namely the appropriateness of anecdotal data, the level of detailed safety and efficacy data currently available through expanded access, suitability for publication, and funding for these activities in the current budget climate. One potential approach to address this is funding from federal or state regulatory agencies or payers for the reasonable costs of follow-up and reporting outcomes.

Regulatory Considerations

The participants then discussed the types of risks, including regulatory and financial, that may affect companies’ expanded access policies. When a company is considering expanded access requests, they consider the risks-benefits of providing the drug outside of a clinical trial as well as the potential for any regulatory issues in an era of litigation and an increased threshold for demonstration of safety. While a company’s provision of a drug for expanded access is voluntary, the FDA does require the company to collect and report safety data. Notably, none of the representatives felt that the FDA is a major regulatory barrier to processing and approving expanded access requests once the sponsor has reviewed the request, assessed the benefit-risk, and determined the request meets FDA requirements and evidentiary standards. In addition, the attendees felt that adverse effects and related liability risk were not of particular concern given that the drugs are assessed on a risk-benefit analysis.

However, companies that make drugs in particularly limited markets with small numbers of patients (for example, for unusual diseases with less than 200,000 patients nationwide which may justify a special designation called “orphan status”) may be more concerned about restrictive labeling if an unusual adverse event occurred even in one or two patients during expanded access of an orphan or small market therapy. However, there is no data of which participants were aware and no public reports that an adverse event during expanded access has harmed regulatory approval.[x] The group opinion was that that safety data would be available eventually in any event and an FDA “safe harbor” provision would not necessarily affect companies’ willingness to accept more requests for expanded access. A final concern was that there is no regulatory mechanism to consider data from expanded access in the evidence generation process for approval.

An Expanded Role for the FDA

While the FDA may not serve as a strong barrier to expanded access, the group considered strategies to promote equitable and fair access. For example, some argued that the breakthrough or priority review categories for FDA review might identify products that could have high potential for expanded access requests. This designation expedites “the development and review of drugs for serious or life-threatening conditions.”[xi] As of mid-April 2014, the FDA had received nearly 180 requests for breakthrough designation, with 44 requests granted.[xii] By hastening the drug development process, the FDA has already begun to bring drugs that have a reasonable expectation of benefit to the market faster. In order to receive breakthrough therapy designation, current legislation might be amended so companies could be asked to provide evidence that the 4 A’s are being followed in some capacity.

The FDA might also assist companies in establishing expanded access programs during open clinical trials in two main areas: process and capacity building. First, in terms of process, the FDA could be asked to create a defined path for regulatory approval with provisions that would encourage companies, both large and small, to include plans for expanded access programs when developing a drug. While FDA’s draft guidance related to INDs notes that larger expanded access programs could threaten enrollment in clinical trials,[xiii] and some participants agreed that this was a significant issue, not all companies have had difficulties enrolling patients in both clinical trials and expanded access programs. For example, one large pharmaceutical company left a Phase 1 clinical trial open for a promising therapy while concurrently enrolling individuals who didn’t qualify for open clinical trials into an expanded access program, without appreciable leakage of enrollees in their advanced phase trials that might affect the key development pathway.

Second, the FDA could support convening around capacity building and sharing best practices with companies. With the understanding that there are many small biotechnology or pharmaceutical companies with limited budgets and staff, the FDA could foster a partnership of large and small companies. This partnership could be achieved by convening meetings where companies share their experiences in creating and sustaining expanded access programs. This could be supported by creating a database for these shared ideas, as well as any expanded access data that can be made legally available, such as how many requests are granted or patient outcomes.

To ensure equitable, consistent, and transparent review of requests, some companies suggested the use of an impartial external advisory board. Similar to an unbiased review from an institutional review board (IRB), this committee could have an advisory or decision making function. Companies with supply constraints may feel that if they cannot give the drug to everyone who requests it, then they should give it to no one. This committee could help the company triage the patients who would benefit the most, and would be protected from liability.

Next Steps

The most efficient and equitable way to make new effective treatments to the largest number of needy patients is regulatory approval, accelerated or otherwise, following successful demonstration of efficacy and safety for a given indication in a specific population. Until that process is complete, access to an experimental therapy is by definition an additional risk, as the agreed necessary safety and efficacy have not yet been demonstrated. True informed consent in this setting is difficult to obtain (i.e. studies have shown that severely ill patients, such as those with life-threating circumstances requesting expanded access, had less retention of information discussed in the informed-consent process and less-clear understanding of the risks of therapy compared to healthier patients[xiv]).

One position companies and regulators can consider is that the default answer to expanded access requests should be affirmative, unless there are compelling reasons for not approving requests to patients with life-threatening illnesses. (Such reasons, for example, might include limited treatment supply or lack of reasonable expectation of benefits versus risks.) Such a position would require, however, that there be broader industry, clinician, regulatory, and patient advocacy agreement of shared principles. This paper outlines the experiences, structural principles, and regulatory considerations of a small group, but further meetings may convene a broader group of stakeholders to build upon these concepts. Such consensus-based approaches might lead to durable systems that meet the needs of desperate patients who have run out of options—while allowing innovation to continue to benefit those who may come afterwards.

Acknowledgements: We are grateful for the participation of the following representatives in the roundtable: Jeff Allen (Friends of Cancer Research), Michelle Berrey (Chimerix), Renzo Canetta (Bristol-Myers Squibb), Anne Cropp (Pfizer), Joseph Eid (Merck), Aaron Kesselheim (Harvard Medical School), Howard Mayer (Shire), Jeffrey Murray (FDA), Lilli Petruzzelli (Novartis), Amrit Ray (Janssen), and Robert Truog (Harvard Medical School). We thank Mark McClellan (Brookings Institution) for helpful discussions of this topic and comments on the manuscript, and to the Richard Merkin Foundation for support. The views and opinions expressed in this article were interpreted and organized by the staff of the Brookings Institution. They do not necessarily reflect the official policy or position of any individual roundtable representative, their companies, or their employers.

References

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• The Four A's of Expanded Patient Access

It is well recognized across the health care industry that the major goals of the Affordable Care Act (ACA) include not only expanding health insurance coverage, but also improving the quality of care and the patient health care experience. A key strategy in achieving these goals is improving the efficiency and delivery of care through innovative financing mechanisms and new delivery models, such as Accountable Care Organizations (ACOs), patient-centered medical homes (PCMHs), bundled payments for acute and post-acute care, and population-based models that aim to improve the health of entire communities. These alternative models emphasize quality and outcomes, while moving care away from the traditional and predominant method of fee-for-service (FFS).¹

The Frontline Work Force
Many conversations focused on the implementation of these models typically emphasize the role of physicians. However, the success of these models relies heavily on the support and manpower of a multidisciplinary team; particularly "frontline health care workers." Frontline workers may include medical assistants (MAs), medical office assistants, pharmacy aides, and health care support workers. Oftentimes, they provide routine, critical care that does not require post-baccalaureate training.²

For example, MAs can play an important role in a medical home model. Upon discharge from the hospital, frontline workers can provide direct outreach to patients that are at high risk for readmission, and discuss any lingering symptoms, worsening of conditions, or medication issues. If necessary, MAs can assign a high-risk patient to a social worker, care coordinator or nurse.³

In a team care environment, frontline health care workers are essential for taking over routine tasks and allowing physicians to employ their specialized skills on their most complex patient cases, which allows all team members to work at “the top of their license”.⁴ Frontline workers can also bridge the gap between patients and a multitude of providers and specialists; help deliver care that is culturally and linguistically appropriate; and provide critical patient education and outreach outside of regular office visits. 

A Workforce in Need of Reform
While team-based care is widely accepted as an industry norm, its current infrastructure is not well-supported. While the frontline workforce represents nearly half of all health care professionals, they are markedly underpaid, underappreciated, and lack formal training to transition into higher-skilled and/or higher paid positions.

A recent study by the Brookings Metropolitan Policy Program “Part of the Solution: Pre-Baccalaureate Healthcare Workers in a Time of Health System Change” demonstrates this glaring disparity between current frontline workforce investment and its value to health reform efforts. The study analyzes the characteristics of the top ten ‘pre-baccalaureate health care workers’ (staff that holds less than an associate’s degree) within the US’s one-hundred largest metropolitan areas (see Table 1).

Table 1: Top ten pre-baccalaureate health care workers in the US’s top one-hundred metropolitan areas

Personal care aides represent a striking example of the underinvestment in frontline workers. The study shows that personal care aides have the lowest levels of educational attainment compared to their peers (32% have no more than a high school diploma), and have the lowest median earnings ($20,000 annually). Meanwhile, The Center for Health Workforce Studies’ (CHWS) estimates that this profession is among the top three national occupations with the highest projected job growth between 2010 and 2020. They are also in highest demand: between 2010 and 2020 there will be an estimated 600,000 personal aide vacancies.⁵ According to this study, MAs are also among the least educated and lowest paid frontline professions. Ninety percent lack a bachelor’s degree and a significant share (29%) are classified as ‘working poor.’

Policy Solutions

A number of policy solutions can be applied to enhance the frontline worker infrastructure. Our recommendations include:

Invest in front line health care workforce training and education. Case studies from a recent Engelberg Center toolkit, outlines how providers are training their frontline workforce to master fundamental skills including care management, patient engagement, teamwork, and technological savviness.

For example, a New Jersey ACO carried out clinical transformation by investing in new frontline staff, and by redefining the role of medical assistants to include health coaching. The return on investment for employers is potentially large. After injecting a substantial initial investment into this project, this ACO saw a 12.3% decrease in net health care costs within the first year of the program’s implementation; as well as significantly improved efficiency, quality of care and patient experience. As the educational curricula for frontline professions are largely variable, more attention should also be spent on the quality of educational content to train these occupations, as well as on developing an understanding of how delivery systems are augmenting traditional educational curricula.

2. Active inclusion of frontline health care workers in payment reform. Although the services of frontline health care workers are beginning to play a role in new payment models, typically frontline staff does not benefit directly from any bonus payments or shared savings incentives. However, their increasingly valuable role in the care team may warrant allowing frontline health care staff to be included in the receipt of shared savings and/or bonus payments based on the achievement of specifically tailored performance and outcomes targets.

The increasing demand for frontline health care workers, driven in part by the ACA’s payment and delivery reforms, will likely spell out a brighter future for these occupations, whose services had routinely been undervalued and underpaid. Future policy efforts should be focused on extending educational grants that have been aimed at primary care and nursing to frontline workers, as well as considering dedicating portions of shared savings to enhancing the earning potential for frontline workers. Some efforts, such as the U.S. Department of Labor’s recent rule to grant wage and overtime protections to home health and personal care aides, are early suggestions of a shift toward greater respect and empowerment for these occupations. It is yet to be seen what effects the continuation of such efforts will have on their high projected attrition trends.