Editors’ Note: Donald Trump has exposed the tension between democracy and liberal values—similar to the Arab Spring, writes Shadi Hamid. This piece originally appeared on The Atlantic.

When I was living in the Middle East, politics always felt existential, in a way that I suppose I could never fully understand. After all, I could always leave (as my relatives in Egypt were fond of reminding me). But it was easy enough to sense it. Here, in the era of Arab revolt, elections really had consequences. Politics wasn’t about policy; it was about a battle over the very meaning and purpose of the nation-state. These were the things that mattered more than anything else, in part because they were impossible to measure or quantify.

The primary divide in most Arab countries was between Islamists and non-Islamists. The latter, especially those of a more secular bent, feared that Islamist rule, however “democratic” it might be, would alter the nature of their countries beyond recognition. It wouldn’t just affect their governments or their laws, but how they lived, what they wore, and how they raised their sons and daughters.

Perhaps more than at any other time, millions of Americans are getting a sense, however mild in comparison, of what it might feel like to lose your country—or at least think about losing your country—because of what people decide to do in the privacy of the voting booth. It still remains (somewhat) unlikely that Donald Trump, the now presumptive Republican nominee, can win a general election. Regardless of the final outcome, however, the billionaire’s rise offers up a powerful—and frightening—reminder that liberal democracy, even where it’s most entrenched, is a fragile thing.

* * *

When I hear my friends debating how, exactly, so many of their fellow citizens could support someone like Trump, it reminds me a bit of Egypt. In my forthcoming book, I relay a telling conversation I had four years ago, which has stayed with me since. A few days after the country’s first post-revolutionary elections concluded in January 2012, I visited my great aunt in her extravagant flat in the posh Cairo suburb of Heliopolis. She was in a state of shock, but worse than that was the confusion. It was one thing for the Muslim Brotherhood, long Egypt’s largest opposition group, to win close to 40 percent of the vote, but how could 28 percent of Egyptians vote for ultraconservative Salafi parties, which believed in the strict implementation of Islamic law?

Like most Egyptians, she personally knew Brotherhood members even if she didn’t quite like them, but she hadn’t had much experience with Salafis and seemed totally unaware that they had extended their reach deep into Egyptian society. She realized, perhaps for the first time, that the country she had thought was hers for the better part of 70 years would never quite be the same. It hadn’t really even been hers to begin with.

What if voters don’t want to be liberal and vote accordingly?

What my aunt feared was that Egypt would become an “illiberal democracy,” a term popularized by Fareed Zakaria in his 2003 book The Future of Freedom, but one that’s still difficult for Americans to fundamentally relate to. In the American experience, democracy and liberalism seemed to go hand in hand, to such an extent that democracy really just became shorthand for “liberal democracy.”

As Richard Youngs writes in his excellent study of non-Western democracy, liberalism and democracy have historically been “rival notions and not bedfellows.” Liberalism is about non-negotiable personal rights and freedoms. Democracy, while requiring some basic protection of rights to allow for meaningful competition, is more about popular sovereignty, popular will, and accountability and responsiveness to the voting public. Which, of course, raises the question: What if voters don’t want to be liberal and vote accordingly?

* * *

When the stakes are high, there is more to lose, and if there is more to lose, those on the losing end of a ballot box have powerful incentives to play “spoiler.” Fortunately, in the post-Civil War United States, the stakes have never reached what political scientist Barry Weingast calls the “threshold” at which citizens decide to defend themselves through extra-constitutional means, including by appealing for the military to take sides. This, in part, is why (good) constitutions are so important: They lower the stakes, reassuring citizens that even if their preferred party loses the election, it’s still just that—an election.

Donald Trump, or more specifically what he represents, calls some of these assumptions into question. Trump himself isn’t quite an Islamist, but he is a proponent of a kind of “illiberal democracy,” even if he himself may not be familiar with the term. Drawing on a wellspring of white nativism and machismo, candidate Trump has regularly made demeaning statements about entire groups of people, including African-Americans, Mexicans, and women. His commitment to the protections enshrined in U.S. constitution are questionable, at best, and if we assume the worst, downright frightening (the difficulty with Trump is that he’s not precise with words, so it’s sometimes hard to make sense of what he’s saying). He has expressed support for registering Muslims in a database, elaborating that they could “sign up at different places.” When a reporter asked how this was different from requiring Jews to register in Nazi Germany, Trump said “you tell me,” prompting The Atlantic’s David Graham to note that “it’s hard to remember a time when a supposedly mainstream candidate had no interest in differentiating ideas he’s endorsed from those of the Nazis.” Trump, for good measure, has also refused to disavow President Franklin D. Roosevelt’s internment of Japanese-Americans.

The U.S. Constitution includes robust civil-liberties protections, enshrined in the Bill of Rights. But these protections are not unlimited. Contrary to popular belief, majorities—if they’re large enough—can, in fact, do nearly anything they want, even in established democracies. It’s only really a question of how high the majoritarian bar is. In the United States, two-thirds of Congress and 75 percent of the states can amend or repeal articles of the Constitution. They could theoretically pass a constitutional amendment banning abortion. In countries like Egypt, Tunisia, and Turkey, where alcohol is currently legal and relatively easy to find, the issue of alcohol consumption is a touchstone for endless “what if” hypothesizing. Yet, Prohibition happened not in any of those countries but in America, with large majorities in the Senate and House of Representatives as well as 46 of 48 states backing the 18th Amendment (of course, banning alcohol in the U.S. wasn’t justified on primarily scriptural grounds, while in Muslim-majority countries, prohibition is seen as fulfilling an explicitly Quranic directive).

In other words, built-in constraints and constitutional “guarantees” aren’t enough on their own to preclude illiberal outcomes. What Americans really depend on, then, is a shared political culture and the ideas and ideals that undergird it. As James Fallows notes, “Liberal democracies like ours depend on rules but also on norms—on the assumption that you’ll go so far, but no further, to advance your political ends.” But all it apparently takes is one man with charisma and an unusually perceptive understanding of the human psyche to change that. There are norms against politicians suggesting that minorities should have special identification cards. There are norms against saying you want to kill the families of terrorists. There are norms against encouraging your supporters to use violence against their political opponents. It’s not entirely clear why you don’t do or say these things (because Trump clearly has), but you just don’t. The very fact that Trump has made such frightening comments on national television—without any corresponding “disqualification” or decline in popular support—has already undermined these longstanding norms.

The United States has had demagogues before, but they rarely make for viable presidential candidates. This is democracy’s blessing as well as its curse: that people you really don’t like—people who you think might threaten the Republic—can actually win. In the specific context of the Republican nomination, Trump opponents basically called for prioritizing good outcomes over democratic ones. They continued to search for possible paths to denying Trump the nomination, despite the fact that, barring acts of God, he was certain to win the popular vote and a plurality of delegates in the primaries.

Even if Trump reached the magic number of 1,237 delegates, which would normally settle the matter, there were those who still seemed intent on scouring the rulebooks, parliamentary procedure, and delegate details in the hope of averting disaster. Democratic norms, the thinking goes, are great in normal contexts, but sometimes the stakes are simply too high to let democratic outcomes stand. As the columnist Walter Shapiro wrote, “[W]ith the threat of the first takeover of a modern political party by an authoritarian who traffics in racism and exudes contempt for the First Amendment ... [t]here would be nothing anti-democratic about GOP leaders using every mechanism in their power to stop Trump.” Nate Silver pointed out that “technically [Republicans would] be able to deny Trump the nomination even if he had a delegate majority by changing the rules at the last minute.” They could still theoretically do something like this, even after Trump’s decisive victory in Indiana. The Republican Party is not a country, and the party can disregard the preferences of primary voters if it so chooses, but elite pacts and back-room negotiations would seem decidedly antiquated during an unusually populist moment in American politics.

[T]here will no doubt be a temptation to defy or otherwise undermine a democratically elected Trump.

This particular debate in some ways mirrors arguments over the tensions between democracy and liberalism, a debate that will only intensify if Trump gains ground on Hillary Clinton in the coming months. It is probably time to err on the side of imagination, since party elites and pundits failed to imagine the unthinkable once already. What if Trump actually wins the presidency? How would we as Americans deal with an outcome that at least some of us see as a potential danger to our Constitution as well as our livelihoods?

If Donald Trump wins, he would have, whether we liked it or not, a democratic mandate. Once in power, he might moderate his rhetoric and policies (yet another data point in the debate over the “inclusion-moderation hypothesis”), rendering at least some of this discussion moot. Yet it’s also possible that, facing a growing terrorist threat and a sputtering economy, more and more Americans might, like their newly elected president, dispense with the norms of reasonable conduct and support extreme measures. Still, a President Trump would be a legitimate president, having been freely and fairly elected by enough Americans. He would be, as much as it pains me to say it, our president. Still, there will no doubt be a temptation to defy or otherwise undermine a democratically elected Trump. For those of us who study the Middle East, the idea of not respecting democratic outcomes is business as usual, but I never thought it would be up for debate in the United States.

* * *

“Deep state” is a phrase that’s used to describe the constellation of autonomous and self-perpetuating institutions, namely the judiciary, military, and security services, which operate outside the glare of the public and are immune to the electorate’s whims. This deep state, acting as the guardian of national identity, puts limits on what elected politicians can hope to accomplish. The deep state was responsible for four coups in Turkey, the most recent of which deposed the country’s first-ever democratically elected Islamist prime minister in 1997.

It would be difficult for Americans to think about their own government—or “regime”—in such terms. The U.S. military is subject to civilian control, while Supreme Court justices, though unelected and appointed to life terms, are nominated by the president and confirmed by the Senate. It is possible, however, to imagine a president so reckless as to activate state institutions against him or her, in a way that makes the notion of an American deep state more meaningful and relevant.

Former CIA Director Michael Hayden ignited some speculative debate when he said that the military “would refuse to act” if ordered by a President Trump to take actions that were clearly illegal, such as killing the families of terrorists. Moreover, he said, military commanders are “required not to follow an unlawful order.” Even short of flagrant illegality, the military can still do what it’s done, at times, with nearly every sitting president. Peter Feaver, a leading expert on civil-military relations, notes that “the historical record is replete with cases of the military shirking—withholding information and options, slow-rolling, end-runs to Congress and the media, inflating cost estimates, etc.—to thwart civilian policies they deem to be unwise.” Considering, however, that Trump would likely be more “unwise” than most past presidents, such tensions could intensify well beyond what America’s political system is accustomed to.

"[C]oup”...is not a word that Americans should ever get used to hearing in everyday political discourse.

One can also easily imagine left-of-center (and right-of-center) civil servants in the Departments of State and Defense working against the president from within to mitigate his effectiveness and even his authority. This would be good, insofar as Americans wouldn’t want their president doing things that were crazy, illegal, or both. But it would still raise difficult questions about democratic legitimacy and how far an elected president can pursue his preferred policies, especially when it comes to issues that aren’t clear-cut. If the military refused to obey orders, however justified their refusal, then it could very well erode norms against military intervention in domestic politics. In response to Hayden’s comments, host Bill Maher joked that the former CIA director was floating “a coup.” This is not a word that Americans should ever get used to hearing in everyday political discourse. The norm against “coups” is a powerful one, which explains why American analysts (if not the U.S. government) are generally uncomfortable with military coups in foreign countries. No one teaches us that military coups are bad. Rather, it’s something we absorb in the process of being American. It goes without saying, so it’s rarely said.

Recently, a few friends (who work on Middle East issues) and I had an interesting although ultimately frightening conversation, as Trump extended his delegate lead over Ted Cruz. Sometimes it’s useful to game out worst-case scenarios, however unlikely they might seem. We tried imagining a dystopian future and came up with internment camps, (threats of) military coups, and pro-Trump militias. Soon enough, the last didn’t seem nearly so farfetched, with volunteers offering to provide security at Trump rallies (for Trump supporters).

* * *

It is hard to imagine such things because, despite a long, low-intensity war on terrorism, America hasn’t faced a large-scale terrorist attack on the homeland since September 11, 2001. Democratic systems produce self-perpetuating norms, because they are accountable to a voting public. It’s this very responsiveness, though, that can be a source of vulnerability, if enough citizens, in the grip of fear, decide to prioritize “security” over liberty. As the legal scholar Christopher Kutz writes in the suggestively titled article “How Norms Die,” democracy can be “at the same time both fertile and toxic: fertile as a source of humanitarian values and institutions, but toxic to the very institutions it cultivates.”

This is something we can measure. As Daniel Bush observed, after analyzing Pew survey data from 2002 to 2014: “During each campaign season, respondents reported having a higher negative impression of Muslim Americans than in non-election years.” This is a bit more mild than the link between elections and religious riots in India. As the historian of religions Michael Cook notes, “There is no doubt that Hindu nationalist politicians believe that communal riots can get out the Hindu vote for them. ... Under the right conditions the communal riot is a winning [electoral] strategy.”

Norm shifting of an even more dangerous kind than India’s can happen rather quickly in countries where democracy is not yet consolidated. For example, millions of Egyptians who demanded freedom and democracy in 2011 turned seemingly against it in less than two and half years, supporting not just a return to authoritarian rule but the August 14, 2013 massacre of more than 800 protesters—what Human Rights Watch calls the “worst mass killing in [Egypt’s] modern history.”

The kinds of shifts that occur in established democracies are less nefarious, but they can happen just the same. Torture is a good example. Kutz calls the spread of global norms against torture “one of the most impressive successes of the post-war period.” Yet, in the United States, these norms began to erode after the attacks of September 11th. Soon enough, torture—or what some were now euphemistically calling “enhanced interrogation”—came to enjoy broad support among the American public. The lesson again is clear. However strong they may first appear, norms, particularly those relating to national security, are more fragile than we might like to think. Once their sanctity is undermined by authority figures (whether presidents or presidential candidates), others can judge that what was once considered shameful is now not just socially tolerated but also necessary, good, and just. This is why “political correctness”—even if it seems irritating and is sometimes abused to restrict reasonable debate—still represents a public good: It makes us think twice about saying things that might contribute to the erosion of liberal and democratic norms.

[N]orms, particularly those relating to national security, are more fragile than we might like to think.

We have now reached a point where current or former presidential candidates from both parties have flirted with the idea of internment camps (former Democratic candidate Wesley Clark has called for “segregating” radicalized Muslims who are “disloyal to the United States”). In a series of incidents that have received less attention, a Tennessee State Representative called for using state institutions, in this case the National Guard, to “round up” Syrian refugees. Meanwhile, the mayor of Roanoke, Virginia, called for suspending assistance to refugees, but went further in an official statement on government letterhead. “I’m reminded,” he wrote, “that President Franklin D. Roosevelt felt compelled to sequester Japanese foreign nationals after the bombing of Pearl Harbor, and it appears that the threat of harm to America from ISIS now is just as real and serious as that from our enemies then.”

No less than Supreme Court justice Antonin Scalia believed that it could happen here. On this, he is on strong ground, since it has, of course, already happened. In 1944, the Supreme Court upheld Roosevelt’s internment of Japanese-Americans in Korematsu v. United States. While Scalia said that the decision was “wrong,” he also issued a warning in his blunt style: “You are kidding yourself if you think the same thing will not happen again.”

The norm against internment has been undermined, even though Americans do not face anything close to the threat presented by the Nazis and Japan during World War II. Which raises the question of what a plurality, or even a majority, of Americans might be willing to support if they had to confront a threat that was truly existential. We Americans are not, today, at war, at least not in the normal sense. I hope to God that we never will be again. But we might be. And this is where Scalia’s words that day were perhaps most chilling, in part because he was right. Evoking the Latin expression inter arma enim silent leges, he reminded the audience that “in times of war, the laws fall silent.” All we will have then are the things we still believe in—our norms. But, by then, they might not be enough.

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. 

There will always be winners and losers as the global economy shifts and evolves. For a long period in the mid- to late 20th century, those losers were cities. Across the developed world, suburbanization shrank inner-city populations just as the industrial base that had once fueled growth succumbed to globalization.

At the end of the 20th century, as global cities such as New York and London pulled themselves out of the malaise of the 1970s, economic growth still eluded many smaller, formerly industrial cities across the United States and Europe. Catalyzing recovery in those older industrial areas was the focus of a decade-long effort of the London School of Economics and the Brookings Institution. As is clear in Cities for a Small Continent, a new book from Anne Power at LSE, the potential in these cities is greater now than ever. In our contribution to the volume, we examine the why and the how of economic transformation in several U.S. cities. 

There has been a lot of focus on the shift in location preferences that is bringing people back to cities. Significant shares of millennials as well as empty nesters are voting for urban communities where they can live, work, and play. At least as important is the restructuring of the U.S. economy—from a closed innovation system where corporations operated isolated research facilities, to an open, networked economy where corporations innovate in collaboration with universities, researchers, entrepreneurs, and investors. Innovation is critical, because as Antoine van Agtmael and Fred Bakker assert in The Smartest Places on Earth, “the era of cheap [in manufacturing] is over; the era of smart has begun.”

These shifts in social preferences and market forces revalue cities and “cityness”—proximity, density, vibrancy, authenticity, and diversity. In particular, population and employment growth is occurring in downtowns and midtowns that have key institutions and assets: universities, medical campuses, cultural venues, historic buildings, walkable streets, and transit connectivity.

This regeneration is being delivered through a new localism in U.S. governance. Every day brings new bottom-up, city-led approaches to the training of workers, the education of children, the mitigation of climate change, the financing of infrastructure, and the development of affordable housing for our workers and quality places for our young and elderly populations.

Across this wide range of activity are some common characteristics.

Cities are harnessing the power of networks of government, business, civic, philanthropic, university, and community institutions and leaders rather than relying on public-sector solutions alone. The focus of the new American localism on unlocking the latent capacity and creativity of public, private, and civic networks differs markedly from the focus of traditional federalism on relationships between levels of government, particularly the federal government and the states.

Cities and metropolitan areas are also deploying capital from an array of public, private, and civic sources at the local, national, and even global levels. With federal investment dwindling, financing of critical projects will increasingly come from public-private collaboration and require experimentation around new forms of innovative finance.

Our chapter highlights four cities in the United States—Pittsburgh, Philadelphia, Cleveland, and Detroit—where this new localism has delivered tangible results. Though each city is at a different point of recovery, all have experienced growth in their cores that has been enabled and co-led by anchor institutions, major philanthropies, private-sector leaders, and civic groups. The biggest investments and decisions in these places have been the results of collaborative processes—proof that cities and the institutions that invest in them can be a source of long-term, strategic thinking that ultimately leads to healthier and more prosperous urban economies.

Similar efforts are spreading across the United Kingdom and Europe, though the systems there tend more toward public-sector leadership. In Sheffield, England, a concerted effort by business and academic institutions to “upskill” the manufacturing base, enabled by the flexibility of a “city deal” from the central government, has made the city a global center of advanced manufacturing. Bilbao, Spain evolved from a manufacturing base to a vibrant urban cultural hub by leveraging the value of publicly owned land and other assets for regeneration purposes. Stories such as these are featured throughout Cities for a Small Continent, as well as in a new series of seven case studies from LSE.

We are still in the early stages of this rebalancing of growth. Cities and metropolitan areas experienced decades of population and employment decentralization, poverty concentration, racial separation, and de-industrialization. Such patterns do not get changed overnight. But they are changing. As cities innovate, those solutions must be captured and codified and then replicated across the world.

Watch the May 24, 2016 LSE launch event for Cities for a Small Continent here: 

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.

Last month’s decision by the Palestinian Authority to schedule municipal elections in early October hardly registered in the West Bank and Gaza Strip, much less here in Washington. In light of Hamas’ recent decision to take part in the process, however, those elections have suddenly taken on new meaning. While the election of some 414 village, town, and city councils across the West Bank and Gaza Strip will not change the face of the Palestinian leadership or alter the diplomatic impasse with Israel, local elections have the potential to unlock the current paralysis within Palestinian politics.

Although Palestinian law calls for local elections to take place every four years, they have only been held twice since the creation of the Palestinian Authority (PA) in 1993, only one of which could be deemed genuinely competitive. The first and only local elections to take place in both the West Bank and Gaza Strip were held in 2004-05, in which Hamas—in its first foray into electoral politics—made major gains. Local elections were again held in 2012, although this time Hamas boycotted the process, preventing the vote from taking place in Gaza and allowing Fatah to declare a sweeping, if somewhat hollow, victory. 

Hamas’ decision to take part in this year’s local elections was therefore something of a surprise. Indeed, Hamas initially expressed dismay at the announcement, accusing the leadership in Ramallah of acting without consulting the other parties. Moreover, should the elections proceed as planned on October 8, they would be the first competitive electoral contest in the occupied territories since Hamas defeated Mahmoud Abbas’s ruling Fatah faction in the 2006 legislative election. Those elections triggered an international boycott of the PA which eventually led to the split between Fatah and Hamas and the current political paralysis.

If nothing else, Hamas’ entry into the elections averts another needless internal crisis in Palestinian politics. A boycott by Hamas would likely have further entrenched the political and geographic division between the Fatah-dominated West Bank and Hamas-ruled Gaza Strip, while dealing yet another blow to the beleaguered National Consensus Government, which despite being accepted by both factions in April 2014 has yet to physically return to Gaza. Movement on the reconciliation track could also help push the long-stalled reconstruction of Gaza, which has yet to recover from the devastating war of 2014.

Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other...[and Fatah] has little to gain from “winning” another electoral process that is largely uncontested.

What explains Hamas’ apparent change of heart? For one, Hamas may believe it has an advantage over Fatah, which continues to suffer from widespread perceptions of corruption and incompetence—a perception reinforced by the collapse of the peace process as well as the unprecedented unpopularity of President Abbas. Hamas may also view the upcoming vote as a way to gauge its current standing and future prospects in anticipation of long-awaited legislative and presidential elections. Either way, Hamas has little to lose from participating in an election that is unlikely to significantly alter the political landscape one way or the other. 

Hamas’ decision to participate in the elections is welcome news for Palestinian voters eager to see the return of competitive elections and a revival of political life after years of stagnation. It even helps Fatah, which has little to gain from “winning” another electoral process that is largely uncontested. More important, as the party that lost both parliamentary elections and a civil war in 2006-07 and that remains the chief proponent of a failed process, Fatah desperately needs a political victory of some kind as well as a basis on which to stake its claim to legitimacy and continued grip on power.

That said, it is important not to overstate the significance of local elections, which in the end will do nothing to address the deeper problems facing Palestinians in the occupied territories, whether from Israel’s continued occupation and its ever-expanding settlement enterprise or the ongoing political dysfunction within their own ranks. On the other hand, the prospect of the first competitive Palestinian elections in a decade represents a small but significant ripple in the otherwise stagnant waters of Palestinian politics.

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.

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

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

ACOs have to assess both the opportunities and the challenges in pursuing risk based payment arrangements. However, there are key strategies ACOs can adopt to help with the transition to greater financial accountability, and higher levels of performance. On July 16^th, our ACO Learning Network hosted a webinar that explored critical success factors and barriers, as well as potential lessons for ACOs to increase their risk-bearing capacity.

Different Payment Models Pose Unique Challenges

Drawing upon an issue brief authored with colleagues from the American Academy of Actuaries, Greger Vigen highlighted some of the actuarial concerns inherent in various risk-based payment models. For example, when organizations undertake one-sided or “bonus only” shared savings arrangements, the arrangement should create incentives that are adequately aligned across the system to reward physicians that are providing not just cost-efficient, but also high-value, care. They must also find ways to create additional non-financial support when the size of provider shared savings is minimal. Both one-sided and two-sided shared savings models can lead to complex calculations in determining the true amount of savings resulting from the arrangement. Organizations undertaking bundled or episode-based payments must clearly determine what is included in specific bundles in order to justify assuming risk for those services.  Although partial capitation lends itself to an increased level of risk by creating strong incentives to reduce inefficiencies in certain parts of the system, such arrangements create effects on areas not covered by the partial capitation arrangement. Finally, by virtue of the increased risk level, global payment arrangements raise solvency considerations for organizations and require significant investment in infrastructure (or use resources from aligned partners) to manage utilization and facilitate appropriate organizational culture change. As programs move forward, there may be a combination of approaches used, including broad risk sharing or partial capitation arrangements between buyer and provider organizations. At the same time, more focused initiative may be used between the provider organization and the provider partners, such as bundled payments or partial capitation to certain providers. 

Critical Elements of High Performing Systems

Regardless of which risk-type arrangements ACOs choose to pursue, there are some critical elements that most high-performing systems share. According to Vigen, high-performing systems typically use a highly analytic process to understand their performance over time, rely on financial committees that are clear and “blunt” about the organization’s financial state, have in place multiple targeted financial initiatives, use payment reform to show how expenses could reduce revenue across multiple specific cases, have advanced clinical reporting systems, develop strong partnerships within and outside the organization to transform care, and use “next generation” analytic tools from outside organizations. Vigen contends that, in order to succeed at true transformation, organizations must develop initiatives aimed specifically at financial results, to supplement other initiatives designed to simply improve quality.  Building around these initiatives provides targeted results that can effectively engage and utilize actuaries. Actuaries and other external partners can help ACOs to more fully address financial issues and develop a framework for the prioritization and allocation of resources that identifies which existing processes to discontinue and which new processes to initiate.

Jim Whisler, a Principal at Deloitte Consulting, added that there are a number of opportunities to realize savings, many of which can be achieved through reducing variation. He emphasized that ACOs should take advantage of “low hanging fruit” that decrease utilization and optimize costs, such as ensuring appropriate use of generic and specialty pharmaceuticals, reducing inpatient stays, increasing use of ambulatory surgery center (ASC), and understanding appropriate use of lab, radiation, MRI, and CT scans. Savings and gain sharing can also vary between the different providers—primary care, specialists, and hospitals.  Ultimately, actuaries and clinical staff alike must be able to analyze data and pinpoint the true drivers of variation.

Effective Strategies Can Yield Significant Cost and Quality Improvements

In order to shed more light on how these strategies can be deployed in health systems, Bart Wald, Chief Executive for Physicians Services at Providence Health and Services, discussed the approaches that he undertook as President and CEO of Physician Associates of the Greater San Gabriel Valley, an IPA in California. Unlike compensation in most IPAs, which often relies either on fee-for-service (FFS) or capitation, Physician Associates, developed a system that uses a combination of both payment models. While capitation has traditionally been used more for primary care physicians (PCPs) than specialists, Dr. Wald emphasized that developing financial incentives for specialists was critical to effectively engaging them.  In his mind, specialists must be integrated and engaged in order to create a truly effective model. The IPA also created a “peer satisfaction” bonus program, in which PCPs and specialists rate each other and those attaining the highest ratings are given an additional bonus payment. The ratings are also posted on the web to increase transparency, and impact physician behaviors. In addition to engaging specialists, Physician Associates made sure to integrate hospitalists into the care team and incorporate social services and mental health staff.

The IPA was able to further transform care by building a population health infrastructure that directed funds towards ambulatory care management, patient-centered medical home (PCMH) development, complex care centers and disease management programs for vulnerable patients. They have also focused on improving the collection and sharing of patient data to better manage generic drug utilization, prescribing and adherence; track and attempt to minimize care received by patients outside of the physician network; and ensure effective continuity of care across the system. In summary, Dr. Wald stressed a number of factors for succeeding at risk-sharing—engaged practice members, adequate physician incentives to improve care performed in the outpatient setting, hospitalists and outpatient coordination on referrals, more advanced pharmacy management, extended disease registries, and integration between physicians and hospitals that includes joint expense management and other synergies. These interventions have resulted in a noticeable improvement in quality of care and led Physician Associates to run at a price and expense advantage below IPAs using a purely FFS payment model.

Dr. Wald also discussed an example of how hospitals are attempting to improve performance through creative partnerships with medical staff using a joint venture limited liability corporation between Providence Health Systems California and local physicians to reduce the occurrences of specific clinical conditions, such as hospital acquired complications, readmissions, and sepsis mortality. These physicians participate in a shared savings model.

Successful Risk-Sharing Arrangements Take Time

While the interventions described above may work and possibly work very well, truly effective risk-sharing design is an iterative process. Organizations must be nimble and able to adapt and modify tactics as necessary. As Greger Vigen emphasized, payment reform can be used as a tactic at the provider level in additional to a broad strategy or vision between provider and buyer.

Downloads

• Issue Brief: Improving the Medicare ACO Program

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

Downloads

• 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.

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 frequently baffling landscape of payment and delivery reform options. To address this need in clear, practical terms, we are pleased to announce the third 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 third case drew on the experiences of the Community Asthma Initiative, an enhanced pediatric asthma intervention, and their efforts in sustainability. The event featured seven brief “TED-style” talks that consider the challenges of delivering pediatric care, while tackling non-medical factors that drive suboptimal care, improving patient and family quality of life, and reducing costs. The agenda included firsthand experiences from patients, payers, policymakers, and clinical leadership from Massachusetts and Arkansas. Sustainable improvement strategies and the financial mechanisms available to encourage innovations in asthma were explored.

Video

• MEDTalk: Pediatric Asthma and Transforming Care for the Most Vulnerable
• A Day in the Life: The Patient Experience
• Challenge Accepted: Delivery of Asthma Care in a Triple Aim World
• The Community Asthma Initiative: A Case Study in Clinical Innovation
• Paying for Asthma Care: Options for Tackling Challenges
• State Medicaid Innovation: Opportunities and Barriers
• A Tale of Success: How to Get the Payer on Board
• Lessons Learned and the Path Forward
• Question and Answer Session

Event Information

Over the past few years, more than 600 Accountable Care Organizations (ACOs) have formed across the country, charged with the dual goals of improving health while also reducing health care costs. Increasingly, evidence on how public and private ACOs are progressing toward these goals is beginning to emerge. Based on these results, major regulatory changes are anticipated in the months ahead that will impact accountable care programs in Medicare, as well as future uptake within the private sector.

On October 20, the Engelberg Center for Health Care Reform hosted a half day forum to assess the latest evidence on accountable care, discuss strategies to overcome unique ACO challenges, and provide an overview of accountable care reforms. Sean Cavanaugh of the Centers for Medicare and Medicaid Services (CMS) provided keynote remarks on the latest Medicare ACO results and potential changes to the Medicare Shared Savings Program (MSSP). Panel sessions featured leading experts in ACO research, implementation and health care policy.

 Join the conversation on Twitter using #ACOFuture or follow @BrookingsMed

Video

• The Medicare Shared Savings Program (MSSP): Looking Ahead
• Big Issues for ACOs Going Forward
• ACO Policy Issues and Solutions on the Horizon

Audio

• The State of Accountable Care: Evidence to Date and Next Steps

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• ACO Public Event full deck FINAL
• 102014_Accountable Care_Transcript

Chattanooga a few years ago faced what many smaller cities are struggling with today—a sudden decline after years of prosperity in the "old" economy. This case study offers a roadmap for these cities by chronicling Chattanooga's demise and rebirth.

Chattanooga is located in the southern end of the Tennessee Valley where the Tennessee River cuts through the Smoky Mountains and the Cumberland Plateau. The city’s location, particularly its proximity to the Tennessee River, has been one of its greatest assets. Today, several major interstates (I-24, I-59, and I-75) run through Chattanooga, making it a hub of transportation business. The city borders North Georgia and is less than an hour away from both Alabama and North Carolina. Atlanta, Nashville, and Birmingham are all within two hours travel time by car.

Chattanooga is Tennessee’s fourth largest city, with a population in 2000 of 155,554, and it covers an area of 143.2 square miles. Among the 200 most populous cities in the United States, Chattanooga—with 1,086.5 persons per square mile—ranks 190th in population density.2 It is the most populous of 10 municipalities in Hamilton County, which has a population of 307,896, covers an area of 575.7 square miles, and has a population density of 534.8 persons per square mile.

With its extensive railroads and river access, Chattanooga was at one time the “Dynamo of Dixie”—a bustling, midsized, industrial city in the heart of the South. By 1940, Chattanooga’s population was centered around a vibrant downtown and it was one of the largest cities in the United States. Just 50 years later, however, it was in deep decline. Manufacturing jobs continued to leave. The city’s white population had fled to the suburbs and downtown was a place to be avoided, rather than the economic center of the region. The city lost almost 10 percent of its population during the 1960s, and another 10 percent between 1980 and 1990. It would have lost more residents had it not been for annexation of outlying suburban areas.

The tide began to turn in the 1990s, with strategic investments by developing public-private partnerships—dubbed the “Chattanooga way.” These investments spurred a dramatic turnaround. The city’s population has since stabilized and begun to grow, downtown has been transformed, and it is once again poised to prosper in the new economy as it had in the old.

This report describes how Chattanooga has turned its economy around. It begins with a summary of how the city grew and developed during its first 150 years before describing the factors driving its decline. The report concludes by examining the partnerships and planning that helped spur Chattanooga’s current revitalization and providing valuable lessons to other older industrial cities trying to ignite their own economic recovery. 

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Ohio, like most other states in the country and particularly its neighbors in the Great Lakes region, is still reeling from the “Great Recession.” This economic crisis, the worst in a half century, has devastated economies across the globe.

While economists have declared that the recession has abated, it will be a long time before the businesses, households, and government treasuries across the country, and specifically in the state of Ohio, shake off the effects. And when the recession’s grip finally breaks, what will Ohio’s economy and landscape look like?

The choices that Ohio’s people and its leaders make—starting now and continuing over the next few years—will determine that answer. Ohioans can decide whether to shy away from manufacturing after the loss of so many jobs, or to transform the state’s old manufacturing strengths, derived from its role in the auto supply chain, into new products, markets, and opportunities. They can decide to opt out of the national shift to a lower-carbon economy, or to be at the forefront of developing clean coal and renewable energy industries and jobs.

They can choose a workforce system that is aligned to the true metropolitan scale of the economy and oriented to the needs of workers and employers. They can choose transformative transportation networks over more roads; smaller, greener, stronger cities; collaboration and regional cooperation to save money, reduce duplication, and bolster regional competitiveness. And instead of trying to go it alone in the 21st century global marketplace, they can maximize the federal resources on offer to support Ohio’s economic transformation and choose to compete effectively for new federal investments.

This report, Restoring Prosperity: Transforming Ohio’s Communities for the Next Economy, lays out some of the specific policy options that will help Ohioans restore the prosperity that the state enjoyed for much of the 19th and 20th centuries, but that it has been struggling to regain for at least a decade, if not longer.

Full Report »

Downloads

• Full Report
• Executive Summary
• Bruce Katz's Speech in Ohio