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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Back from the brink

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

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

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

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

U.S. and EU officials have called on Turkey to show restraint amid concerns that Friday's failed coup attempt will be the pretext for an authoritarian crackdown. Turkey’s ability to investigate the putsch will be compromised by the fact that President Recep Tayyip Erdoğan has repressed the media and weakened the judiciary, says Kemal Kirisci, of the Brookings Institution. The coup attempt will likely bolster Erdoğan’s efforts to consolidate power, and that will make any investigation into the true causes of the coup difficult, Kirisci says.

President Recep Tayyip Erdoğan has pinned responsibility on the cleric Fethullah Gülen, who lives in self-imposed exile in the United States. Is that credible?

It is possible [that the Gülen movement is responsible], but this needs to be thoroughly investigated. The [Turkish] government has long argued that Fethullah Gülen leads a parallel state from Pennsylvania, where he has been living since 1997. The journalist and academic Ali Bayramoğlu has said that the movement, going back to the 1980s and early 1990s, began to systematically place their students in the police and military academies. These students were closely monitored and accompanied.

Other commentators have argued that it's unbelievable how F-16 pilots, on whom the state has spent more than a million dollars each to educate, attacked the Turkish parliament, military headquarters, intelligence services, and communications centers. How can a well-trained, prestigious F-16 pilot do this unless they are deeply attached to a cause? The movement also [includes] high-ranking judges and officers, including many one-star generals, who have been arrested.

Erdoğan has renewed his calls on the United States to extradite Gülen. Is this more plausible after the attempted coup?

Turkey has for a long time been seeking Gülen’s extradition, but the United States has not been cooperative, saying there was not enough evidence to build a case. However, the [U.S.-Turkey] extradition treaty refers to an obligation to extradite anyone who attempts to assassinate the leaders of one or the other country. There clearly was an attempt to assassinate Erdoğan: the hotel where he had been staying was attacked, and there was an attempt to control the airport where he was supposed to land. A necessary condition of extradition is that a convincing connection between the coup and the sought-after person is established; that should be the focus of cooperation.

Many analysts expect that Erdoğan will use the attempt as a pretense to invest the presidency with full executive powers, as he’s long sought.

The difficult issue will be to assess Erdoğan’s accusations independent of his political ends. Many commentators say the allegations put forward by the government serve his political aspirations: Erdoğan has become, de facto, the executive president of Turkey, but he wants to introduce an element of legality to it, which will require either a constitutional amendment or a completely new constitution. Opinion polls just before the coup suggested that the public, even supporters of [the ruling Justice and Development Party (AKP)], did not look favorably on it. This kind of threat to the system gives him considerable leverage [to codify an executive presidency], and I suspect he will follow that path rather than what some commentators are calling for, bringing the polarized country to a consensus through dialogue.

How to sort that out from the pursuit of the truth will be a difficult exercise, and I’m not sure today’s Turkey is equipped to do it, given the way the media has been repressed and the judiciary has been brought under the influence, if not control, of the government. These measures raise serious doubts about Turkey’s ability to investigate this within the realm of the rule of law.

The Incirlik air base, from which a U.S.-led coalition carries out air strikes against the self-proclaimed Islamic State, just reopened after a temporary closure. Will the coup attempt have broader implications for the anti-ISIS campaign?

Cooperation on ISIS is important, but much more so is the future of democracy in Turkey. A Turkey that is democratic is a Turkey of the rule of law, and a secular Turkey is one in which sympathy for such extremist groups is much less. Such a Turkey shares common values with the West, which makes cooperation much easier.

It looks like a large number of officers—colonels as well as one-star generals—were involved, and so the Turkish military is going to experience a period of weakness. That’s where U.S. cooperation, on intelligence and counterterrorism, is critical. Such cooperation demands trust. That trust will partially, but importantly, be a function of [cooperation over] the Gülenist dossier.

The United States and Turkey are going to have to find a way to cooperate over the PYD (Kurdish Democratic Union Party). [Editor’s note: the United States backs the Syrian Kurdish party’s militant wing, the YPG, to combat the Islamic State; Turkey says the group has aided its compatriots in Turkey, the PKK, whose insurgency against the state resumed in July 2015]. The United States enjoys leverage over the PYD, and now it’s ever more important that it keeps the PYD in line so it does not become involved in the conflict in Turkey and strengthen the hand of the PKK while Turkey is vulnerable.

Turkey hosts roughly three million refugees and the country is party to an agreement with the EU to stem migration to Europe. What will EU-Turkey relations look like in the aftermath of the coup attempt?

If the perpetrators had gained control of government, it would have led to civil war, so the very fact that the coup attempt collapsed is saving Europe from waves of Turkish asylum seekers. The EU will need to expand its basis of cooperation with Turkey, because this coup attempt will adversely impact Turkey’s ability to deal with these refugees. There will likely be a purge from some of the bureaucracies and organizations that deal with them.

More broadly, both U.S.-Turkey and EU-Turkey ties have been strained lately. Will the Turkey’s alliance with the West come out on stronger footing after their condemnation of the coup attempt?

Helping with the investigation to establish the truth will be critical. The way in which, at the end of the day, [the EU and United States came out] with support for the elected government, just as Turkish opposition parties did, should entitle them to some influence, calling on Turkey to live up to the norms, standards, and values of democratic society.

The EU and United States together must reanchor Turkey solidly within the Western alliance. Erdoğan, as much as [the United States and EU member-states] may resent him or disagree with policies, must be made to feel that he's welcome back in the ranks, the way he was between 2003 and 2010, on the condition he reforms his policies.

Erdoğan and the people around him, especially [former Prime Minister Ahmet] Davutoglu, had delusions of grandeur. They dreamed they were going to lead the ummah, the Islamic world. This is all gone now: the emperor is naked. Erdoğan seems to recognize Turkey has boxed itself into a corner and wants to come out in the direction of the West. There is nowhere else to go. Turkey needs tourism, international trade, and foreign investment, and to protect its national security. On all these grounds it needs cooperation, and it’s not going to come from Iran, China, or Russia, even if that might be their preference. It can only come from the West.

Turkey may also recognize that the West is in trouble too, and if the West cannot come out of that trouble, Turkey will be in even deeper trouble. Brexit is going to have a negative impact on Turkey's export market and tourism. An EU in trouble is not going to be able to give visa liberalization to Turkish nationals, which symbolically will anchor Turkey in the West, and is also important economically. If the EU and United States move to the right and say no to free trade agreements [and migration], Turkey will not benefit. Both sides next each other even more than in the past.

Copyright © Council on Foreign Relations 2016, republished with permission

Event Information

The failed coup in Turkey on July 15 to 16, organized by factions within the Turkish military in an attempt to overthrow the government of President Erdoğan, represents both a victory and a new trial for Turkish democracy. Although the Turkish citizenry brought the country back from the brink of anarchy and civil war, many analysts see last week’s events as a consequence of the political instability and discord that has been mounting for years as Erdoğan has consolidated powers, marginalized the opposition, and redefined Turkey’s democracy. How will the president react in the aftermath of the coup? Will the democratic backsliding intensify, or can the thwarted coup offer new opportunity for reconciling the deeply-polarized nation?

The upheaval and political instability in Turkey also holds significant implications for Turkey’s foreign policy and the fate of a neighboring region already in turmoil from the war in Syria and insecurity in Iraq. The West desperately needs a stable, democratic, and predictable partner in its NATO-ally Turkey to address the many challenges besetting the region and to fight the Islamic State (or ISIS). How will recent events affect regional stability and Turkey’s cooperation with the West on security issues, including the resettlement of Syrian refugees? What does the failed coup mean for the coalition against ISIS engagement in Syria?

On July 20, the Foreign Policy program (FP) at Brookings hosted a panel discussion to consider these questions and other domestic and international consequences of the coup attempt in Turkey. Brookings Senior Fellow and Director of the Center on the United States and Europe Fiona Hill introduced and moderated a wide-ranging conversation featuring FP Senior Fellows Shadi Hamid, Kemal Kirişci, Michael O'Hanlon, and Ömer Taşpınar.

After the discussion, the speakers took questions from the audience.

Video

• Turkey coup attempt was a shock
• Institutional collapse of Turkey unprecedented
• Disaster averted in failed Turkey coup
• Incirlik Air Base not irreplaceable
• Turkey after the coup attempt: Implications for Turkish democracy, foreign policy, and the future of the Syrian War

Audio

• Turkey after the coup attempt: Implications for Turkish democracy, foreign policy, and the future of the Syrian War

Transcript

• Transcript (.pdf)

Event Materials

• 20160720_turkey_coup_transcript

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.

Turkish President Recep Tayyip Erdoğan has responded to last week’s coup attempt with a hammer. Over the span of just a few days, more than 50,000 people have been fired from their jobs or detained on suspicions that they’re connected to the coup or to the Gülenist movement (which President Erdoğan blames for the coup attempt). Now emergency rule has been imposed, suggesting that more detentions may follow.

Turkish leaders are assuring everyone that the state of emergency is meant to control the situation and to preserve Turkish democracy. But many observers, including in the West, aren’t buying it: There are legitimate fears that these measures will actually further consolidate Erdoğan’s authoritarian rule. And the consequences of Turkey’s continued drift away from democracy isn’t only a human rights or governance problem—it could become a real geopolitical challenge for the West. 

The swinging pendulum

Turkey—literally the bridge between Europe and Asia—sometimes seems of two minds on governance issues. On the one hand, its leaders express a commitment to a Western form of governance based on the rule of law, liberal democracy, transparency, and accountability. On the other—and more in the vein of governance styles in Russia, Iran, and China—they sometimes reject what they see as outside interference, restrict civil liberties and government transparency, and promote a heavy state role in the economy. 

Although Turkey was welcomed into NATO and other transatlantic institutions after World War II—at a time when Soviet expansionism was a real fear—its commitment to democratic values has always been shaky. The military’s shadow loomed large over Turkish politics (last week’s coup attempt was far from the first) and the country’s human rights record was poor, particularly on minority rights. 

Many thought that all this would change when Erdoğan and his Justice and Development Party (AKP) came to power in 2002. They introduced political reforms that propelled Turkey toward EU membership. The Turkish economy excelled: Many people in Turkey once depended on remittances sent by Gastarbeiters (guest workers) in Germany and other West European countries, for instance, but the country quickly became host itself to immigrants from neighboring countries. Tourists, business people, students, athletes, and artists poured into the country in the millions. And Turkey enjoyed considerable soft power in the region and the world, often touted as a model in the wake of the Arab Spring of a country that properly paired mainstream Islamism and democratic governance. None of this would have been possible were it not for Turkey’s growing adherence to Western governance norms and its membership in the transatlantic community. 

But the picture has since become rather grim. The events of the past week have renewed concerns about the state of Turkish democracy, yes—but those concerns have in fact been growing for years. Turkey’s commitment to supporting freedom of expression, freedom of the media, anti-corruption efforts, and liberal markets has been in serious doubt for a while. Meanwhile, the economy has stalled, related in part to political developments and to a recent spate of terror attacks that have seriously damaged the overall security situation. It is no wonder that Turkish per capita income—which peaked at $10,800 in 2013—has now fallen to 2009 levels, at $9,950. (That’s an almost 10 percent drop in the span of just two years.) Turkey’s further slide away from Western governance norms would likely only make matters worse, making Erdoğan’s promise of putting Turkey among the largest 10 economies in the world a fantasy.

If you ask Erdoğan and his AKP colleagues why reforms sputtered out, they’re likely to answer with conspiracy theories: They’ll blame the West, the EU, the interest rate lobby, and others. But the AKP has failed to be self-critical, which could have helped it succeed. 

Turkey’s choice of orbit

So if Turkey seems to be moving away from Western norms, is it also moving away from the West? Possibly. In November 2013—after years of stop-and-go accession talks with the EU—Erdoğan sought Russian President Vladimir Putin’s support for accepting Turkey into Eurasian organizations like the Shanghai Five. That could be a big geostrategic gain for Russia, something not lost on the Russian press.

Western Europe and the United States would be the biggest losers if Turkey moved closer to Russia’s camp. Losing their partnership with Turkey would deliver a serious blow to the fight against ISIS in Syria and Iraq, for one thing. But it would also further dim prospects that Turkey might really embrace Western-style democracy any time soon. As Ted Piccone has written, Turkey has the potential to be a linchpin of the liberal international order—and a long-term downturn in the country could have wide detrimental effects in regional and global governance. 

The path ahead

Finally, is there a role for the United States in all this? In the short term, as Ömer Taşpınar has argued, the United States should offer real help to Ankara in investigating the role of Pennsylvania resident Fethullah Gülen and his movement in last week’s coup attempt. Extradition is a highly sensitive issue, and the United States must defend its legal standards. At the same time, that kind of cooperation could build trust in U.S.-Turkey relations, calm Ankara’s paranoia about a potential U.S. role in the coup attempt (and therefore possibly help minimize the damage to Turkish democracy that Ankara itself might cause in its heavy-handed response), and help the United States build credibility on the rule of law. A thorough investigation—including into the Gülenists—is important for determining who was behind the coup attempt. And it’s in U.S. interests to know: As Turkey is a NATO member, a threat against it should be considered a threat against all members. It is in no NATO member’s interest to allow a political earthquake like this to push Turkey from its fold or towards a rival mode of governance. 

This isn’t to downplay the burden now on Ankara; the Turkish government shouldn’t forget that its respect for civil liberties and the rule of law once helped earn it a lot of international respect and a place in the Western community. It’s disappointing that the AKP and Erdoğan supporters have failed to capitalize on their country’s potential. Among its peers in the Muslim world, Turkey had once made the most progress in terms of democratic values and economic growth. Many would still like to believe that that Turkey still exists, in spite of recent setbacks. But for Turkey to win back those gains, its leadership will have to proceed very cautiously and with reason. 

Editors’ Note: The attempted coup in Turkey was, for many observers, reminiscent of another recent July uprising in a key American ally: the 2013 military takeover in Egypt. These coups were a disaster for U.S. policy in both cases, and would have been regardless of how they turned out, argues Jeremy Shapiro. This post originally appeared on Vox.

Friday’s attempted military coup in Turkey demonstrates that yet another U.S. partner in the Middle East seems to be descending into domestic unrest. The spectacle was, for many observers, reminiscent of another recent July uprising in a key American ally: the 2013 military takeover in Egypt. There, as in Turkey, a powerful military in a country with a history of coups rebelled against a democratically elected Islamist government.

Egyptians and Turks alike will naturally reject such comparisons and emphasize the unique nature of their respective situations—not least that the coup in Egypt succeeded and the one in Turkey failed. They have a point. The differences in the local political context are more important than the superficial similarities.

But from an American perspective, there is a key similarity: These coups were a disaster for U.S. policy in both cases, and would have been regardless of how they turned out.

In each case, the U.S. government’s immediate response to fast-moving situations was to issue bland statements urging calm and condemning violence. Regardless, it gets blamed for not acting forcefully enough, and often accused of directly instigating the violence. In the end, a relationship with the government that emerges is strained, both by such accusations and by the ensuing crackdown and human rights abuses that usually follow both successful and unsuccessful coups.

How does the United States end up in this no-win situation so frequently? Why is domestic unrest in faraway countries like Egypt and Turkey such a problem for the United States?

The essential problem is that the United States cannot just do foreign policy business with its partners. Because of America’s own values and domestic politics, it needs to get involved in their domestic political struggles. It needs to promote democracy and civil society in its partners and to take positions on controversial domestic issues such as the proper functioning of democratic institutions and the protection of human rights or media freedom.

This means that when domestic politics explodes, the United States is often caught in the middle.

Partnership isn't enough

Both Egypt and Turkey are “key security partners” of the United States. This means the U.S. government needs these countries to deal with critical security issues.

Turkey is a NATO ally that sits at the crossroads of practically every geopolitical issue in the Middle East. It is particularly critical for the fight against ISIS. The United States and its anti-ISIS coalition partners supply their partners on the ground in Syria through Turkish territory and use the military base at Incirlik in Turkey to launch airstrikes against ISIS. The foreign fighters that replenish ISIS’s ranks have also often come into Syria via Turkey.

Egypt is also seen as an important partner for counterterrorism. It is struggling to cope with jihadist groups, some of them linked to ISIS, in the Sinai Peninsula. Egypt also provides the United States military with privileged access to the strategic Suez Canal, helps keep the peace with Israel, and helps ensure that weapons that might be used to attack Israel don’t get to Hamas through Egypt’s border with Gaza.

One could argue about whether these are truly important security interests for the United States. But the key point is that successive American governments since, in the case of Turkey in the 1950s and in the case of Egypt in the 1970s, have accepted that they are.

They have accordingly sought to build an effective partnership with both countries. The United States is committed, through NATO, to defend Turkey in case of aggression. And the United States provides Egypt with more than $1.3 billion a year in military assistance and $150 million a year in economic assistance, making it the second-largest recipient of U.S. foreign aid in the world (after Israel).

But the United States can’t just give these guarantees and this money without taking on some moral responsibility for what goes on in these countries. Debates over these countries in U.S. domestic politics reflects this sense of moral responsibility.

If the Egyptian military overthrows a democratically elected government, U.S. Congressmembers will quite naturally ask why the United States is giving nearly $1.5 billion a year to a government that shoots peaceful protesters in the street. If the Turkish government suppresses media freedom or arrests judges, U.S. human rights groups will similarly question why the United States accepts such actions by a NATO ally.

Hoping to escape from this dilemma, the U.S. government has long sought to promote the Western values of democracy and human rights in its security partners.

But particularly in the Middle East, this has rarely worked. The United States doesn’t really know how to democratize these societies, and in any case, it values its security relationship with the government too much to exert sustained pressure.

So even as the Egyptian military overthrew the democratically elected government, the United States continued to give it military aid. Even as Turkish President Recep Tayyip Erdoğan has moved in an increasingly authoritarian direction, the United States has stepped up its security cooperation with Turkey over ISIS.

The result is a hypocrisy that is evident and annoying to both the government and its opposition. Every effort to pressure governments on human rights elicits furious reactions and denials. And when, despite the rhetoric about human rights from U.S. officials, nothing really improves, the population grows cynical about U.S. motives.

So every effort to build up civil society organizations spawns a million conspiracy theories about U.S. involvement in domestic politics.

The crucible of a coup

Military coups or revolutions in U.S. partners always bring these tensions out into the open. They force the United States to confront in extremely fraught circumstances whether it most prizes its security relationship or its commitment to democratic values.

Usually, it can’t decide. The immediate reaction tends to be both muddled and seen through a lens of decades of built-up distrust of the United States. The conspiracy theorists find ample evidence for every preconceived notion.

The reaction to the Turkish coup has been a textbook example of this dynamic. The U.S. government condemned the coup, but it took several hours. The Turkish government interpreted this as hedging and evidence of ill will.

President Erdoğan has blamed the coup on Fethullah Gülen, a Muslim cleric in self-imposed exile in the United States, and wants the U.S. government to extradite him to Turkey.

When Secretary of State John Kerry said the United States would need solid evidence to extradite him, a Turkish government minister accused the United States of instigating the coup itself. As Kerry warned Turkey about the large number of arrests, the Turkish government temporarily restricted use of the Incirlik base and arrested its Turkish commander on suspicion of involvement in the coup. The conspiracy theorists went wild:

If the United States wanted to break out of the vicious cycle, it would either have to end its security partnership with Turkey or accept that that partnership means accepting Turkish authoritarianism. But if experience is any guide, the United States will not take either of those paths.

As in Egypt, the U.S. relationship with Turkey will probably survive these events, albeit in diminished form. After a period of distancing, both sides will accept that they need each other for their mutual security problems too much to allow a complete breakdown.

But at the same time, the distrust of the United States within the government and the hatred of the United States within the population will grow. The U.S.-Turkey relationship will fail to evolve into a true alliance of trust and thus be of limited use in defeating ISIS or ending the civil war with the Kurds in Turkey.

In the meantime, Turkey's roiled domestic politics will continue as Erdoğan attempts to cleanse Turkish politics of his opponents. The next coup or revolution may be the last that the strained U.S.-Turkish alliance can withstand.

Editors’ Note: Whatever one thinks of Erdoğan, there is little doubt: As tenuous as Turkey’s future remains, a disaster—one that would have had ripple effects across the region—was averted last week, writes Shadi Hamid. Here, he makes sense of the coup and why it failed, drawing out a few key lessons. This post originally appeared in Newsweek Middle East.

On a Friday night, just a day after a horrific attack in Nice, France, that had taken the lives of more than 80, rumors of a military coup in Turkey began to spread.

It was a reminder that even the most unlikely things can happen in a Middle East that tends to follow the maxim “if it can get worse, it probably will.” Nearly everyone, including senior U.S. officials, were caught by surprise. Political scientist Jay Ulfelder had put the probability of a Turkish coup attempt in 2016 at a mere 2.5 percent.

For all of the ruling AK Party’s faults and President Recep Tayyip Erdoğan’s intensifying paranoia and authoritarian tendencies, perhaps the most consequential victory the party could claim was the neutralization of Turkey’s powerful military, which long considered itself the guardian of Turkish secularism. The army had been responsible for a steady succession of coups. The first, in 1960, where a democratically elected prime minister was hung to death was never too far from Erdoğan’s mind, despite the passing of more than five decades. But it had seemed that after 14 years of AKP rule, Turkey had finally moved beyond its own dark history of military intervention. But it hadn’t.

Coups introduce a dynamic where there can only be one winner. Coup plotters, once they make their decision to act, have an incentive to fight (and kill) to the very end, since failure usually entails a harsh prison sentence, or worse. In countries already wracked by existential, winner-takes-all politics and deep social polarization, coups, especially if they succeed, are likely to provoke ongoing bloodshed and civil conflict. Whatever one thinks of Erdoğan, there is little doubt: As tenuous as Turkey’s future remains, a disaster—one that would have had ripple effects across the region—was averted.

Turkish President Recep Tayyip Erdogan addresses the crowd following a funeral service for victims of the thwarted coup in Istanbul at Fatih Mosque in Istanbul, Turkey, July 17, 2016. Photo credit: Reuters/Alkis Konstantinidis.

In making sense of the coup and why it failed, there are a few key lessons. One has to do with the importance of norms. Despite a long history of military intervention, norms against coups have entrenched themselves in recent years, including, most importantly, among secular parties; among these are groups that have a pronounced dislike of Erdoğan. This norm shift happened quickly. As recently as 2008, Turkey’s Constitutional Court was just one vote away from shuttering the AKP for “anti-secular activities.” The idea that disputes, however intense, must be resolved through legal, democratic means has spread and deepened, cutting across societal and ideological divides.

The country’s last successful coup was in 1997, when the military forced the resignation of an Islamist-led coalition government. The Islamists of the Welfare Party, an AKP predecessor, were unable or unwilling to take to the streets en masse, allowing the army to quickly impose itself. This time around, however, Erdoğan and other AKP leaders immediately called on their supporters to mobilize throughout the country and resist the army’s moves.

For me, Friday night was a frightening moment, presenting a key test for an international community that has had a checkered record of (not) opposing coups against deeply flawed but still democratically-elected Islamists. As I watched the coup attempt unfolding in real time, I was reminded of the sick feeling I had on July 3, 2013, the day the Egyptian military overthrew President Mohamed Morsi of the Muslim Brotherhood. We have the benefit of knowing how the coup turned out there, producing a brutal outcome responsible for the worst mass killing in modern Egyptian history, according to Human Rights Watch.

Of course, that Turkey didn’t follow in Egypt’s footsteps does not mean that the country is in the clear. In 2015, I conducted extensive interviews with current and former AKP figures for my new book on the “problem” of Islam and politics. While the coup attempt cannot be reduced a simple Islamist-secular divide, the aftermath of the coup—with Erdoğan moving aggressively to crack down on both actual and potential opponents—is likely to exacerbate ideological divisions over the role of religion in Turkish society.

With the other Islamist groups I’ve studied, including the Egyptian and Jordanian Muslim Brotherhoods, there was always at the least the pretense of sounding conciliatory. Not so much in Turkey, where some of the AKP figures I interviewed openly expressed a raw, bitterness toward their secular opponents. For them, after all, it was quite personal. Most lived through the 1997 coup and the so-called “February 28 process” which aimed to deal a decisive blow against the broader Islamic movement in every facet of public life, particularly in the educational sphere, with the shutting down of imam hatip religious schools.

A senior advisor to former Prime Minister Ahmet Davutoglu told me that Turkey’s normalization required “carrying Ataturk to his grave,” referring to the still revered founder of modern Turkey and the architect of decades of forced secularization. For this advisor, the scars hadn’t gone away. He was still furious that his wife, because she wore a headscarf, wasn’t able to work at a state hospital until 2014, despite the fact that, by then, the AKP had been in power for 12 years.

In short, Turkey has a long way to go, considering that questions over Islam, identity, and the very meaning of what it means to be both Turkish and Muslim remain unresolved. But, at least for a moment, observers can take some solace in the fact that, as bad as it still might be, it could have been worse—perhaps much worse.

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.

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

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

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

Top Eight Medicare ACO Challenges

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

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

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

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

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

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

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

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

Downloads

• Issue Brief: Improving the Medicare ACO Program

Contributors: Alice M. Rivlin and Christine Dang-Vu

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

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

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

Top Eight ACO Challenges

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

Downloads

• Issue Brief: Improving the Medicare ACO Program

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

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

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

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

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

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

Erica has a history of cardiac issues. She visits her doctor for a regular checkup and her doctor writes a new prescription to better control her heart disease. Unfortunately, her doctor didn't mention any instructions, except to take it once a day. Erica thanks her doctor and heads to the pharmacy. At the check-out counter, the clerk hands Erica her new prescription drug, in addition to three documents stapled to the bag that he says "will explain everything you need to know about your medication." Later on, while reviewing the materials at home, Erica is overwhelmed by the information, which is in fine print and difficult to understand. She is frustrated and confused, and tosses the documents in the trash.

This scenario is not uncommon. Research suggests that about 50 percent of Americans find it difficult to read health information.[i] Consumers who cannot find the information they need, or who do not understand the information because it is presented in a convoluted manner, are less likely to use it to prevent unnecessary medical errors. In Erica’s case, she could have ended up in the emergency room because she missed some basic warnings about her prescription. For example, one warning might have been that she should not chew the medication because it was an extended release capsule. Chewing the capsule could release the entire day’s dose at once, resulting in an unintended overdose.

We know that consumers are receiving information – sometimes too much information. Not only are consumers receiving pages of medication information, the information they receive is uncoordinated and sometimes conflicting. Some documents are written by the drug manufacturer, and others are written by pharmacies or another third party. Some medication information documents are FDA-approved and others are not.

The real question is – could medication information be presented in such a way that it would be more useful for consumers? The answer is a resounding “yes.” One study found that just 75 percent of consumer medication information met the minimum criteria for usefulness.[ii] That number might be impressive as a field goal percentage in the NBA, but for consumers it represents an unmet need for high quality medication information.

The U.S. Food and Drug Administration (FDA) has spent the past several years working with stakeholders to determine the most effective methods for conveying medication information. One overarching principle that has emerged from FDA’s engagement with the health care community is the need for a single, standardized document to replace the numerous existing documents. This document is identified as Patient Medication Information (PMI).

PMI creates an easier way for consumers to access and understand their medication information. By presenting the most salient pieces of information – including drug uses, warnings, side effects, and directions – on a single page that is easy to navigate, PMI can be a useful tool for enhancing treatments and preventing avoidable medication errors or side effects. PMI holds promise both for consumers and the broader health care system. For consumers, PMI could contribute to better outcomes and an overall improvement in patient experience. For health systems, PMI’s positive impact on medication adherence could improve performance on quality measures, such as hospital readmissions, that could lead to shared savings or other rewards.

Through a cooperative agreement, the Engelberg Center for Health Care Reform at the Brookings Institution has worked in collaboration with FDA over the past few years to convene a series of workshops focused on identifying best PMI practices – for example, how to make PMI both more usable and accessible.  Workshop participants identified several guiding principles for improving the content, format, and distribution of PMI.

PMI Guiding Principles

PMI content should be consumer-friendly. Expert stakeholders identified a lack of consumer-friendly information as one of the most important barriers to effectively communicating critical medication information. To fix this problem, the language used in PMI will need to be simplified, patient-centric, and understandable across the entire spectrum of health literacy levels. The types of information that should be included in PMI must be essential for taking a medication properly. Extraneous information, such as a discussion of previous treatments a consumer must have previously tried and failed before receiving the new prescription, may be more confusing than helpful.

The best PMI formats are simple and easy to navigate. Consumers don’t want to be given a technical-looking instruction manual when they pick up their prescriptions. Participants at the workshops generally agreed that it would be ideal to keep PMI to a single page. They also agreed that actionable headers that help consumers locate the information they are looking for are preferable to the question and answer format (e.g., “Uses” and “Directions” are more effective than “What does the drug treat?” and “How do I use the drug?”). There was consensus on the point that consumers will ultimately decide the best format.

Access to PMI will be bolstered by multiple channels of distribution. Paper is still the primary source of medication information, and is preferred by certain demographics. However, technology is revolutionizing the way consumers receive information. This is generally good for society, but it introduces some challenges, including the fact that consumers now have more access to information of questionable quality.  One method for ensuring access to consistent and high quality PMI would be to have a central repository for all PMI documents. This approach could support distribution of both printed and electronic PMI. Access to PMI could be further enhanced by making it available on smartphones and via email.

On July 1, the Center will convene a public meeting that will provide an opportunity for the health care community to discuss the issues mentioned above. Researchers will give an update on progress made since the previous meetings and share the lessons they learned from recent studies. Diverse stakeholders – including patient advocacy groups, providers, pharmacies, and drug manufacturers – will provide their perspectives on the future of PMI and assess their role in making high quality PMI a reality. 

There are many issues that need to be addressed in exploring the promise of PMI. However, one thing that participants at the July 1 meeting should remember is this: Keep it simple, stakeholders.

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

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

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

The Clinical Scenario: Living With Cancer

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

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

The Challenge: Controlling Spending While Improving Patient-Centered Care

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

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

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

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

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

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

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

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

Table 1: Care Redesign Elements Undertaken by NMCC

The Key Levers: How Can COME HOME Be Sustained?

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

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

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

Table 2: Comparison of Alternative Payment Models for Oncology

The Path Ahead: How Can These Models Assist NMCC?

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

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

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

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

Lessons Learned

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

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

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

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

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

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

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

Event Information

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

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

Video

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

Event Materials

• Oncology Case Study August 2014 FINAL WEB

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

Where are we now?

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

The Fee-For-Service System

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

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

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

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

Accountable Care Organization Model

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

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

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

Without Bundled Payment...

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

With a Bundled Payment...

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

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

Patient-Centered Medical Home Model...

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

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

Same Effectiveness, Different Cost...

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

How Pathways Creat Savings...

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

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

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.

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• 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

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• The Four A's of Expanded Patient Access

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

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

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

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

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

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

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

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

Policy Solutions

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

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

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

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

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

Event Information

The Brookings Institution and the American Enterprise Institute (AEI) collaborated to ask: if you were to redesign Medicare without spending more money, what would you keep and what would you change? A new report on a Center for Healthcare Decisions program provided insight into the public’s willingness to restructure Medicare in the face of tightening budget constraints. Using an interactive, computer-based system, program participants faced the challenge of making Medicare more responsive to the needs of current and future beneficiaries.

Were participants willing to accept limits on their choice of provider or reduced coverage of low-value medical care? Would they accept the need for greater personal responsibility in their use of health services? Would they agree that Medicare should adopt other policies to promote fiscal responsibility?

Watch event video.

The Centers for Medicare and Medicaid Services (CMS) recently reported more optimistic news about the Medicare Accountable Care (ACO) Program, which began in 2012.  CMS released final first year financial and quality results for the Medicare Shared Savings Program (MSSP) ACOs and preliminary year two financial and quality results for the Pioneer ACO Model (Pioneer ACOs).

Financial Results: To date, the two programs have generated savings of $817 million—$372 million of which has been saved by Medicare and another $445 that has been returned to the ACOs through shared savings. While these savings are not final calculations, they suggest that both programs have produced modest savings in the first two years with some variability across ACOs.

Pioneer ACOs: Pioneers, generally considered more advanced ACOs, were able to generate more total program savings in year two than in year one ($96 million vs. $87 million), while also qualifying for shared savings payments of $68 million. The Medicare Trust Fund saved approximately $41 million in year two of the Pioneer program. In total, Pioneer ACOs were able to achieve an approximately 1% lower spending trend overall for the Medicare population than fee-for-service (1.4 vs. 0.45 percent lower per capita growth). Seventeen of the 23 Pioneer ACOs had positive or neutral financial performance, eleven of which were able to slow health spending enough to share in savings. On average, those ACOs saved $4.2 million in 2013, up from $2.7 million in 2012; shared savings grew from $1.2 million to $13 million. Six Pioneers generated losses, three of which were significant enough to require those Pioneer ACOs to share in the losses. While remaining Pioneers have been able to attain bigger savings in year two of the program, almost a third of original participants have left the program—some have moved to the lower risk MSSP, while others have focused on commercial ACO contracts or higher levels of risk in MA programs.

MSSP ACOs: MSSP ACOs were likewise able to reduce overall cost trend by slightly less than 1 percent. Of the 220 MSSP ACOs that started in 2012 or 2013, roughly one-quarter (53) were able to reduce spending enough to qualify for total shared savings of over $300 million. An additional 52 ACOs reduced spending compared to their benchmarks, but not enough to qualify for shared savings. One ACO that opted for track two (two-sided financial risk) overspent its benchmark by $10 million and owed shared savings of $4 million. MSSP ACOs as a whole were able to reduce spending by $652 million below their financial benchmarks and saved the Medicare Trust Fund $345 million, including repayment for the track 2 ACO losses.

Quality Results
Medicare ACOs continue to improve significantly on overall quality scores.  Both Pioneer ACOs and MSSPs have been able to attain higher average performance than quality benchmarks and better performance than Medicare fee-for-service on measures with data, such as colorectal screening, tobacco cessation, and depression screening.

Pioneer ACOs: All 23 Pioneer ACOs that remain in the program out of the initial 32 successfully reported their quality measures in their first two years.  The mean quality scores for Pioneer ACOs increased by 19 percent, from 71.8 percent in 2012 to 85.2% in 2013. Pioneer ACOs increased average improvement by 14.8 percent across all quality measures and overall improvement on 28 of 33 quality measures. Patients also report a positive experience receiving care from Pioneer ACOs—the ACOs improved average performance scores for patient and caregiver experience across 6 out of 7 measures.

MSSP ACOs: MSSP ACOs, as a group, posted even more improvement in quality scores than the Pioneer ACOs. MSSP ACOs starting in 2012 and 2013 were able to improve 30 of 33 quality measures, including measures such as patients’ rating of clinicians’ communication, beneficiaries rating of doctors, health promotion and education, screening for tobacco use and cessation, and screening for high blood pressure. In total, MSSP ACOs are experiencing higher CAHPS patient experience survey scores than Medicare fee-for-service, suggesting that patients are engaged and satisfied with being a part of an ACO. Additionally, MSSP ACOs achieved higher average performance rates on 17 of 22 Group Practice Reporting Option (GPRO) Web Interface measures reported by other large physician group fee-for-service providers.  Over 125,000 eligible providers or supplier members of ACOs qualified for incentive payments through PQRS (Physician Quality Reporting System) in 2013. Unfortunately, nine MSSP ACOs failed to successfully report their quality scores, four of which would have otherwise qualified for shared savings.

Digging Deeper into the Results
While program level analysis of financial performance is meaningful, a deeper analysis of the data and organizational characteristics of those MSSP ACOs that earned shared savings reveals some interesting trends. A little over half of those earning shared savings were physician-led ACOs (26/49) and more than a third of these physician led ACOs operate in Florida (10/26). The continued success of physician-led ACOs is consistent with previous findings that these ACOs may be better positioned than institutionally-based ACO to reduce overall costs. In addition, analysis by The Center for Medicare and Medicaid Innovation (CMMI) found that there is no relationship between savings/loss performances and whether the ACO included a hospital. Hospital-led ACOs were overall less likely to share in savings than physician-led ACOs. These two findings together suggest that ACOs can experience success even without an official hospital affiliation, paving the way for more physician practices to join and excel at accountable care.

Interesting regional trends are beginning to emerge from the data. Florida and Texas had the highest concentration of ACOs sharing in savings. Of the 30 Florida-based MSSP ACOs, more than a third (11) were able to share in savings, while almost half (7/15) Texas-based MSSP ACOs qualified for shared savings. Furthermore, the top two earning MSSP ACOs were from Texas (Memorial Herman with $28.34 million) and Florida (Palm Beach ACO with $19.34 million), respectively. The concentration of shared savings in these two states raises important questions about what is driving the high level performance. Are these MSSPs more likely to succeed because of a higher financial benchmark based on disproportionately greater regional Medicare spending? Do these ACOs have a leg up from the start because of their patient population and historical spending trend? Are physician ACOs more likely to form and succeed in these higher-cost areas? The success of these programs should not be understated, but further analysis may be needed to better understand performance drivers so appropriate program adjustments may be considered to level the playing field among MSSP ACOs across all regions.

Next Steps
While these latest Medicare ACO results are encouraging, more work needs to be done. The Pioneer Program recently lost its tenth program participant, Sharp Healthcare, bringing the total number of Pioneers down to 22. Like some other Pioneers that have exited the program, Sharp was dissatisfied with the benchmark and payment methodology and was no longer willing to assume financial risk that they felt was too great. This is just one among many policy and implementation issues with which Medicare ACOs are struggling. In June, we published a set of recommendations to ensure the long-term sustainability of the Medicare ACO program by addressing eight major ACO challenges. These results seem to reinforce the need for several of these recommendations for change in the Medicare ACO Program.

CMMI, which administers the Pioneer ACO Program, has recognized some of these challenges and has begun giving ACOs some greater flexibility in operating within the program. These changes include allowing them to move to population-based payments, waiving the 3-day hospitalization rule to allow ACOs to directly admit qualified patients to skilled nursing facilities, and experimenting with “voluntary alignment” to allow beneficiaries to attest to a primary care physician to offset some of the limitations of the existing attribution process. These are moves in the right direction; however CMS must continue to engage providers across the country to make sure the program remains viable.

Meanwhile, the MSSP will add another round of participants in January 2015 and CMS is expected to release a notice of proposed rulemaking that will amend the current operating requirements for the MSSP program later this year. The scope and nature of changes could dramatically impact the interest of new organization, as well as the continued participation of current MSSP and Pioneer ACOs.  Medicare ACOs will likely be encouraged to continue innovating to improve quality and reduce costs in the Medicare program, but the Medicare ACO program must continue to evolve to meet provider and beneficiary needs to ensure continued success.

Note: This blog has been corrected since its original posting on September 22 to reflect more accurate data.

Downloads

• Changes to Medicare ACO Program

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

The Centers for Medicare and Medicaid Services (CMS) recently released more detailed ACO-level data for participants in first two years of the Pioneer ACO Model. The program, which is designed for health systems with more experience assuming financial risk for patient populations, has generated savings and improvements in quality measures, but has also struggled to retain participants. The program began with 32 provider organizations; following a series of recent announcements there are now 19 total participants.

Last month, CMS announced that the Pioneer Program was able to yield total program savings of $96 million in its second year and resulted in ACOs sharing in savings of $68 million. CMS also reported that the Pioneers were able to improve mean quality scores by 19 percent and increased performance on 28 of 33 measures between performance year one and performance year two.

Financial Results

The latest financial results provide more participant-level data and allow for a new level of analysis of performance across all these ACOs. In year one of the program, financial performance for individual Pioneers ranged from a gross loss of $9.31 million to a gross savings of $23.34 million. Thirteen Pioneers reduced costs enough to qualify for shared savings, with an average of $5.85 million returned to the ACOs, ranging from $1.00 million to $14.00 million. One ACO owed shared losses of $2.55 million. The remaining eighteen ACOs were within the minimum savings or loss rate and did not earn shared savings or owe money to Medicare due to losses.

Following year one, nine Pioneer ACOs either left the Medicare ACO program entirely, or moved to the lower risk Medicare Shared Savings Program (MSSP). Eight of the nine Pioneers that left the program failed to reduce spending in their first year. Out of the remaining 23 participants in the second performance year, three of these ACOs opted to defer reconciliation until the end of Performance Year 3. The 20 Pioneers with final Performance Year 2 data had financial performance ranging from a gross savings of $24.59 million to gross losses of $6.26 million. Fourteen ACOs reduced spending in Performance Year 2, eleven of which reduced enough to qualify for shared savings. The average shared savings for these ACOs was $6.55 million, ranging from $1.22 million to $13.41 million. Three Pioneers shared losses, averaging $2.33 million back to the Medicare program.

The table below shows the breakdown of ACOs according to whether they reduced spending, increased spending, shared in savings, or owed money back to Medicare due to losses. More than half of the Pioneers were able to reduce spending in year one (18/32) and year two (14/23), with more than one-third of total ACOs earning shared savings in each year as well.

The data also suggest that those ACOs that were most successful in reducing spending in the first year were also more likely to reduce spending in their second year. As the chart below shows, three ACOs that earned shared savings in year one owed money back to Medicare due to losses in year two, while no ACO that had shared losses in year one was able to attain shared savings in year two.  

Quality Results

CMS also released ACO-level performance on all 33 measures for Pioneer participants in year one and year two. The 23 ACOs that remain in the Pioneer Program showed overall improvement in average quality scores from the first to second performance year. The ACOs also improved overall on 28 of 33 measures, as the chart below shows.

The quality domain with the greatest improvement in year two was Domain 4 (At Risk-Populations) which saw an overall improvement from 67.5% to 83%. The marked improvement in this domain suggests that ACOs are making progress at better coordinating and delivery care for high-risk patients, many of whom have multiple chronic conditions. Chronic care management for conditions such as diabetes, coronary artery disease, and hypertension is critical for the continued success of accountable care efforts. All other domains saw average quality improvement as well, summarized below.

Likewise, almost all of the individual Pioneer ACOs improved their performance on quality measures from year one to year two. Of the ACOs that remained in the program for year two, all but one ACO was able to improve its overall quality score in its second year.

Additionally, the percentage of Pioneer ACOs performing in the 80^th or 90^th percentile in quality scores also increased from year one to year two, as shown in the chart below.

Putting Together Financial and Quality Results

In year one of the Pioneer Program there appeared to be no direct correlation between average quality scores and gross savings or losses for individual ACOs. This may not be unexpected, especially since Pioneer ACOs in their first year are eligible for shared savings simply by reporting their quality. In subsequent years, however, the ACO’s quality score impacts the level of shared savings that the Pioneers are eligible to receive, so we might expect a bit more alignment between quality and financial performance. Average quality scores and level of savings or losses for each of the 32 first year Pioneer ACOs is below.

After year two, there still does not appear to be a direct relationship between higher quality scores and level of savings or losses in the Pioneer Program. Further examination of results begs additional questions about why certain ACOs clustered in different parts of the grid relative to others.

Of those ACOs in the red circle above— higher total savings and relatively average quality scores—two of the ACOs are from the Boston area and the remaining ones from other large metropolitan areas (New York City; Orange County, CA; Phoenix, AZ; and Detroit, MI). The average per capita Medicare spending for the counties corresponding to these ACOs is $11,544, compared to an average of $10,384 for counties corresponding to all 23 of the Pioneer participants.

Meanwhile those ACOs within the yellow circle had the highest quality scores, but also experience financial losses or slight savings. Many of these ACOs are from less densely populated areas, such as Maine, Wisconsin, and Illinois. There are a number of factors that could be contributing to their quality success, but little financial savings—healthier patient populations, a smaller or more engaged patient population, financial baselines impacted by lower per capita spending in these areas, or other factors driven by their region. Further analysis of these ACOs and the other public and private ACO programs, including both their characteristics and regional market characteristics, will provide needed further insights on the factors most likely to drive success.

Next Steps

These ACO-level data reflect the range of experiences across Pioneer participants. Some ACOs have sustained positive performance to date, while others have seen diminishing rates of return. Those organizations more committed to clinical transformation, patient outreach, and organizational change may be more likely to do better, but further analysis of differences in performance could enable the Pioneer Program and ACOs to achieve bigger impacts over time.

It is hard to know what the third performance year of the Pioneer program will show, but as noted earlier, the Pioneer Program has already lost over a third of its original 32 participants. Despite the decline in participation and mixed results so far, CMS remains optimistic and committed to the program, and the overall number of Medicare, Medicaid, and privately-insured individuals in ACO arrangements continues to rise. We can anticipate a proposed rule impacting the MSSP, likely later this Fall, which will impact elements of the Pioneer ACO program. Regulatory changes that may help increase the ability of the Medicare ACO programs to support better care while ensuring sustainability include: adjustments to attribution methods, benchmark calculations, collection and sharing of data with ACOs, updating performance measures, linking to other ongoing payment and delivery reforms, and creating more financial sustainability for program participants. The current Pioneer program can be a key step toward effective payment reform, but further steps are needed to assure long-term success.

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

Event Information

In its 50th year, the Medicare program currently provides health insurance coverage for more than 49 million Americans and accounts for $600 billion in federal spending. With those numbers expected to rise as the baby boomer generation ages, many policy experts consider this impending expansion a major threat to the nation’s economic future and question how it might affect the quality and value of health care for Medicare beneficiaries.

On June 5, the Center for Health Policy at Brookings and the USC Leonard D. Schaeffer Center for Health Policy and Economics hosted a half-day forum on the future of Medicare. Instead of reflecting on historical accomplishments, the event looked ahead to 2030—a time when the youngest Baby Boomers will be Medicare-eligible—and explore the changing demographics, health care needs, medical technology costs, and financial resources available to beneficiaries. The panels focused on modernizing Medicare's infrastructure, benefit design, marketplace competition, and payment mechanisms. The event also included the release of five policy papers from featured panelists.

Please note that presentation slides from USC's Dana Goldman will not be available for download. For more information on findings from his presentation download the working paper available on this page or watch the event video.

Video

• Challenges and opportunities facing Medicare in 2030
• Eligibility, benefit design, and financial support
• Could improving choice and competition in Medicare Advantage be the future of Medicare?
• Improving provider payment in Medicare

Audio

• Strengthening Medicare for 2030

Transcript

• Uncorrected Transcript (.pdf)

Event Materials

• Burtless Slides
• 20150605_medicare_2030_transcript