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

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

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

Continuity of the PLD for the fourth consecutive term 

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

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

Reasons for the victory

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

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

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

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

Challenges

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

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

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

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

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

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

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

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

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

This piece was originally published by International IDEA. 

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

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

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

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

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

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

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

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

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

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

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

Across this wide range of activity are some common characteristics.

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

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

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

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

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

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

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

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

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

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

Back from the brink

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

Downloads

• Issue Brief: Improving the Medicare ACO Program

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

Abstract

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

Call to Action: The Importance of Expanded Access Programs

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

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

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

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

Laying the Groundwork with Shared Experiences

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

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

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

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

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

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

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

Development of Structural Principles: The Four A's 

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

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

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

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

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

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

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

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

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

Regulatory Considerations

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

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

An Expanded Role for the FDA

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

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

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

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

Next Steps

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

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

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

References

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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.

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• Changes to Medicare ACO Program

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

Our third case drew on the experiences of the Community Asthma Initiative, an enhanced pediatric asthma intervention, and their efforts in sustainability. The event featured seven brief “TED-style” talks that consider the challenges of delivering pediatric care, while tackling non-medical factors that drive suboptimal care, improving patient and family quality of life, and reducing costs. The agenda included firsthand experiences from patients, payers, policymakers, and clinical leadership from Massachusetts and Arkansas. Sustainable improvement strategies and the financial mechanisms available to encourage innovations in asthma were explored.

Video

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

Event Information

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

With over 16 million people and nearly 8.6 million jobs, America's older industrial cities remain a vital-if undervalued-part of the economy, particularly in states where they are heavily concentrated, such as Ohio and Pennsylvania. They also have a range of other physical, economic, and cultural assets that, if fully leveraged, can serve as a platform for their renewal.

Read the Executive Summary  »

Across the country, cities today are becoming more attractive to certain segments of society. Meanwhile, economic trends-globalization, the demand for educated workers, the increasing role of universities-are providing cities with an unprecedented chance to capitalize upon their economic advantages and regain their competitive edge.

Many cities have exploited these assets to their advantage; the moment is ripe for older industrial cities to follow suit. But to do so, these cities need thoughtful and broad-based approaches to foster prosperity.

"Restoring Prosperity" aims to mobilize governors and legislative leaders, as well as local constituencies, behind an asset-oriented agenda for reinvigorating the market in the nation's older industrial cities. The report begins with identifications and descriptions of these cities-and the economic, demographic, and policy "drivers" behind their current condition-then makes a case for why the moment is ripe for advancing urban reform, and offers a five-part agenda and organizing plan to achieve it.

Publications & Presentations
Connecticut State Profile
Connecticut State Presentation 

Michigan State Profile
Michigan State Presentation 

New Jersey State Profile
New Jersey State Presentation 

New York State Profile
New York State Presentation 

Ohio State Profile
Ohio State Presentation
Ohio Revitalization Speech

Pennsylvania State Profile 

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Introduction

During 2006, the United States saw a considerable upswing in the number of new mortgage defaults and foreclosure filings. By 2007, that upswing had become a tidal wave. Today, national homeownership rates are falling, while more than a million American families have already lost their homes to foreclosure. Across the country, boarded houses are appearing on once stable blocks. Some of the hardest hit communities are in older industrial cities, particularly Midwestern cities such as Cleveland, Detroit, and Indianapolis.

Although most media attention has focused on the role of the federal government in stemming this crisis, states have the legal powers, financial resources, and political will to mitigate its impact. Some state governments have taken action, negotiating compacts with mortgage lenders, enacting state laws regulating mortgage lending, and creating so-called “rescue funds.” Governors such as Schwarzenegger in California, Strickland in Ohio, and Patrick in Massachusetts have taken the lead on this issue. State action so far, however, has just begun to address a still unfolding, multidimensional crisis. If the issue is to be addressed successfully and at least some of its damage mitigated, better designed, comprehensive strategies are needed.

This paper describes how state government can tackle both the immediate problems caused by the wave of mortgage foreclosures and prevent the same thing from happening again. After a short overview of the crisis and its effect on America’s towns and cities, the paper outlines options available to state government, and offers ten specific action steps, representing the most appropriate and potentially effective strategies available for coping with the varying dimensions of the problem.

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Louisville/Jefferson County is the principal city of America’s 42nd largest metropolitan area, a 13-county, bi-state region with a 2006 population estimated at 1.2 million. It is the largest city by far in Kentucky, but it is neither Kentucky’s capital nor its center of political power.

The consolidated city, authorized by voter referendum in 2000 and implemented in 2003, is home to 701,500 residents within its 399 square miles, with a population density of 4,124.8 per square mile.² It is either the nation’s 16th or its 26th largest incorporated place, depending on whether the residents of smaller municipalities within its borders, who are eligible to vote in its elections, are counted (as local officials desire and U.S. Census Bureau officials resist). The remainder of the metropolitan statistical area (MSA) population is split between four Indiana counties (241,193) and eight Kentucky counties (279,523). Although several of those counties are growing rapidly, the new Louisville metro area remains the MSA's central hub, with 57 percent of the population and almost 70 percent of the job base.

Centrally located on the southern banks of the Ohio River, amid an agriculturally productive, mineral rich, and energy producing region, Louisville is commonly described as the northernmost city of the American South. Closer to Toronto than to New Orleans, and even slightly closer to Chicago than to Atlanta, it remains within a day’s drive of two-thirds of the American population living east of the Rocky Mountains.

This location has been the dominant influence on Louisville’s history as a regional center of trade, commerce and manufacture. The city, now the all-points international hub of United Parcel Service (UPS), consistently ranks among the nation’s top logistics centers. Its manufacturing sector, though much diminished, still ranks among the strongest in the Southeast. The many cultural assets developed during the city’s reign as a regional economic center rank it highly in various measures of quality of life and “best places.”

Despite these strengths, Louisville’s competitiveness and regional prominence declined during much of the last half of the 20th Century, and precipitously so during the economic upheavals of the 1970s and ‘80s. Not only did it lose tens of thousands of manufacturing jobs and many of its historic businesses to deindustrialization and corporate consolidation, it also confronted significant barriers to entry into the growing knowledge-based economy because of its poorly-educated workforce, lack of R&D capacity, and risk-averse business culture.

In response, Louisville began a turbulent, two-decade process of civic and economic renewal, during which it succeeded both in restoring growth in its traditional areas of strength, most notably from the large impact of the UPS hub, and in laying groundwork for 21st century competitiveness, most notably by substantially ramping up university-based research and entrepreneurship supports. Doing so required it to overhaul nearly every aspect of its outmoded economic development strategies, civic relationships, and habits of mind, creating a new culture of collaboration.

Each of the three major partners in economic development radically transformed themselves and their relationships with one another. The often-paralyzing city-suburban divide of local governance yielded to consolidation. The business community reconstituted itself as a credible champion of broad-based regional progress, and it joined with the public sector to create a new chamber of commerce that is the region’s full-service, public-private economic development agency recognized as among the best in the nation. The Commonwealth of Kentucky embraced sweeping education reforms, including major support for expanded research at the University of Louisville, and a “New Economy” agenda emphasizing the commercialization of research-generated knowledge. Creative public-private partnerships have become the norm, propelling, for instance, the dramatic resurgence of downtown.

The initial successes of all these efforts have been encouraging, but not yet sufficient for the transformation to innovation-based prosperity that is the goal. This report details those successes, and the leadership, partnerships, and strategies that helped create them. It begins by describing Louisville’s history and development and the factors that made its economy grow and thrive. It then explains why the city faltered during the latter part of the 20th century and how it has begun to reverse course. In doing so, the study offers important lessons for other cities that are striving to compete in a very new economic era. 

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

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

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

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

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

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

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Part of the larger Northeast Ohio regional economy, the Akron metropolitan area is composed of two counties (Summit and Portage) with a population of just over 700,000, and is surrounded by three other metropolitan areas. Akron is located approximately 40 miles south of Cleveland, 50 miles west of Youngstown, and 23 miles north of Canton. The Cleveland metro area is a five-county region with a population of 2.1 million. The Youngstown metro area includes three counties, extending into Pennsylvania, and has a population of 587,000. Canton is part of a two-county metropolitan area with a population of 410,000.

The adjacency of the Akron and Cleveland Metropolitan Statistical Areas (MSAs) is an important factor in the economic performance of the Akron region. The interdependence of economies of the two MSAs is evidenced by the strong economic growth of the northern part of Summit County adjacent to the core county of the Cleveland metropolitan area. This part of Summit County beyond the city of Akron provides available land, access to the labor pools of the two metropolitan areas, and proximity to the region’s extensive transportation network.

Although affected by economic activity in the larger region, the fate and future of Akron and its wider region are not solely determined by events in these adjacent areas. While sharing broad economic trends with its neighbors, the Akron metro area has been impacted by a different set of events and has shown different patterns of growth from other areas in Northeast Ohio.

This study provides an in-depth look at Akron’s economy over the past century. It begins by tracing the industrial history of the Akron region, describing the growth of the rubber industry from the late 1800s through much of following century, to its precipitous decline beginning in the 1970s. It then discusses how the “bottoming out” of this dominant industry gave rise to the industrial restructuring of the area. The paper explores the nature of this restructuring, and the steps and activities the city’s business, civic, and government leaders have undertaken to help spur its recovery and redevelopment. In doing so, it provides a series of lessons to other older industrial regions working to find their own economic niche in a changing global economy. 

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Introduction

Ohio has already taken important steps to address the state’s ongoing foreclosure crisis, yet the crisis continues, causing distress for thousands of families and individuals, and destabilizing cities, towns and neighborhoods across the state. Therefore, the state, its local governments and private stakeholders need to do still more to deal more effectively with the crisis and its impacts on the state’s housing stock, cities and neighborhoods.

What is often termed the “foreclosure crisis” is actually a multi-dimensional crisis, in which the collapse of the housing bubble, the devastation caused by the lax and often irresponsible credit practices that accompanied and perpetuated that bubble, the resulting freeze on commercial and consumer credit, and the worldwide recession are interwoven, and can only with great difficulty be untangled. In Ohio, those forces are further exacerbated by profound changes to the state’s historical economic underpinnings. Ohio cannot solve the crisis by itself, but it can significantly mitigate its impact on people, neighborhoods, and towns and cities. These mitigating efforts will also help preserve the value of homes and neighborhoods in the state, and place Ohio in a stronger position to benefit from the future economic recovery.

The paper begins with a short summary of current conditions and the actions the state has already taken to address the wave of foreclosures, followed by a discussion of areas for future action. This discussion will address mitigating both the individual and community impacts of foreclosure, but will give particular emphasis to the critical issue of softening the blow of foreclosure on communities, which up to now has been less of a focus for state action.

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

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

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

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

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

Full Report »

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

For over 100 years, the driving force of Ohio’s economy has been the state’s so-called Big Eight cities—Columbus, Cleveland, Cincinnati, Toledo, Akron, Dayton, Canton, and Youngstown. Today, though, the driving reality of these cities is sustained, long-term population loss. The central issue confronting these cities—and the state and surrounding metropolitan area—is not whether these cities will have different physical footprints and more green space than they do now, but how it will happen.

The state must adopt a different way of thinking and a different vision of its cities’ future—and so must the myriad local, civic, philanthropic, and business leaders who will also play a role in reshaping Ohio’s cities. The following seven basic premises should inform any vision for a smaller, stronger future and subsequent strategies for change in these places:

• These cities contain significant assets for future rebuilding
  
• These cities will not regain their peak population
  
• These cities have a surplus of housing
  
• These cities have far more vacant land than can be absorbed by redevelopment
  
• Impoverishment threatens the viability of these cities more than population loss as such
  
• Local resources are severely limited
  
• The fate of cities and their metropolitan areas are inextricably inter-connected
  

These premises have significant implications for the strategies that state and local governments should pursue to address the issues of shrinking cities.

Full Paper on Ohio's Cities » (PDF)
Paper on Shrinking Cities Across the United States »

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