Mr. Quality Goes to Washington - Pharmaceutical Executive

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Mr. Quality Goes to Washington
Don Berwick, whose pioneering ideas about quality and safety are all over the healthcare reform bill, was just tapped by President Obama to head the Centers for Medicare and Medicaid Services. His mission is to translate the new law he helped inspire into practice. But with Republicans, industry lobbyists, and his own bureaucracy so invested in the status quo, what are Berwick’s odds for success?


Pharmaceutical Executive


A "Controversial" Nomination

Berwick's recess appointment was, unsurprisingly, met with an immediate uproar from the Republicans. The White House rationalized the move in this way: "Many Republicans in Congress have made it clear in recent weeks that they were going to stall the nomination as long as they could, solely to score political points. But with the agency facing new responsibilities to protect seniors' care under the $938 billion Affordable Care Act, there's no time to waste with Washington game-playing."

With some of the law's most consumer-friendly features kicking in this fall, Democrats are hoping that concrete benefits will win over some skeptics. The first round of $250 checks were mailed to 80,000 seniors in the Medicare Part D donut hole in July. "I don't see politics getting in the way of the implementation of healthcare reform—at least not until January 2015," says Ian Spatz, founder and principal of Rock Creek Policy Group. "But by then, I think most Americans will realize the benefits of reform and be quite happy with it."

Thomas Scully, who led CMS under President George W. Bush, summed up the view from inside the healthcare industry: "Berwick is a very thoughtful, reasonable, mainstream guy. For people to paint him as an outrageous, radical choice is just plain unfair. But no one who knows him has any doubt that he could more than hold his own in a public hearing with a lot of Republican screaming and gnashing of teeth."


Don Berwick Administrator, Centers for Medicare and Medicaid Services
In circumventing a congressional vote on his nominee, Obama has stoked the controversy. Even a month later, as Pharm Exec went to press, Republicans were still demanding a public hearing for Berwick. A letter signed by all Senate Finance Committee Republicans reads: "If [Berwick] is not provided opportunity to present his qualifications for the position in the usual process, it casts a shadow over his legitimacy and authority to serve as administrator during a critical time for CMS."

Man on a Mission

Berwick is already being slammed by opponents as an "academic elitist," but attempts to disqualify him as "out of touch" with the real world is not even remotely accurate. His interest in doctoring wasn't limited to the individual patient—his mission has been to heal the system. After getting a public health degree, he ran quality improvement for Harvard's Health Care System (now Harvard Pilgrim). In 1991, he founded the Institute for Healthcare Improvement (IHI), a feisty startup that grew into a global force backed by donations from top donors such as the Gates, Macarthur, and Robert Wood Johnson foundations. And at IHI, Berwick has worked with large numbers of doctors, nurses, and hospitals to test new approaches.

"To many in the quality and safety world, IHI became their church, and Don its Pope," Dr. Robert Wachter, associate chairman of the Department of Medicine at the University of California, San Francisco, wrote on his widely read blog, Wachter's World. "[IHI] ran on a shoestring for its first decade, fueled largely by the considerable power of Don's vision and personality. Then came the [Institute of Medicine] reports on safety [2000] and quality [2002]—reports that Don had a major hand in crafting—followed by a national movement that promoted transparency, pay-for-performance, tougher regulatory requirements, increased media, and legislative interest."

IHI's 100,000 Lives Campaign promoted best practices for hospitals and physicians, while its rapid response team model has been adopted as a national standard of cardiovascular care. IHI has also spearheaded alternative delivery and payment models such as accountable care organizations (ACOs), in which hospitals and doctors are motivated to collaborate—and limit care—because their CMS payment is based on clinical outcome rather than a list of services, diagnostics, and treatments. But Berwick's provocative idea that quality and cost are not inversely related is what most animates reform. To support his claim, Berwick cites the decades-long (and disputed) research by Jonathon Skinner and Elliott Fisher at the Dartmouth Institute for Health Policy and Clinical Practice showing that some regions and hospitals in the US with the highest spending on healthcare, including intensive advanced diagnostics, achieve outcomes that are no better than their cheaper cousins.

In anticipation of a public hearing on Berwick's original nomination in April, Health Affairs' editor John Inglehart wrote, "If Berwick can persuade ... skeptics that the IHI is built on collaborations with healthcare providers, not regulatory regimes formulated by the government, maybe he will have a chance to translate his private successes into public victories." Installed now not by vote but by fiat, Berwick will now have to sell reform to the American people.


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