Experience hath shewn, that even under the best forms of government, those entrusted with power have, in time, and by slow operations, perverted it into tyranny.
I do not mean to say that this government is charged with the duty of redressing or preventing all the wrongs in the world; but I do think that it is charged with the duty of preventing and redressing all wrongs which are wrongs to itself.
If there has been one central figure in the efforts to digitize the American healthcare system, that figure would be David Blumenthal. In 2008, as an advisor to the Obama transition team, it was Blumenthal who first proposed pulling $30 billion out of the $700 billion pile of stimulus money to promote the adoption of electronic health records, an idea that eventually became the HITECH incentive program. In 2009, he became the third director of the Office of the National Coordinator for Health Information Technology (ONC). On his watch, the Meaningful Use program was launched. It was Blumenthal’s personality—elegant, unfailingly polite, and politically astute—that shaped the early successes of the Meaningful Use program, and his departure from the policy-making scene in 2011 shaped it yet again. Since then, Meaningful Use has become the most controversial topic in healthcare IT.
I met Blumenthal in his office at Harkness House, the headquarters of the Commonwealth Fund, where he is now CEO. The mansion, on Manhattan’s Upper East Side, was built in 1908 by the descendants of Stephen Harkness, an heir to the Standard Oil fortune, and became home to the Commonwealth Fund in 1952. Its outer layer of Tennessee marble is constructed in the style of the Italian Renaissance, not the more ornate French style popular in the early twentieth century. On entering the building, one is struck by the details: the vaulted ceilings, the stone columns, the oak panels, the rococo niches. Blumenthal’s magnificent office was once the home’s library. Books still dominate the room, whose walls are lined with Brazilian rosewood. Taken as a whole, Harkness House manages to be timeless and impressive, but not ostentatious.
Impressive but restrained would also describe the 66-year-old Blumenthal. For three decades, he was a Harvard professor, his tenure punctuated by periodic postings to a variety of high-impact policy roles: presidential campaign advisor to both Michael Dukakis and Barack Obama, a U.S. Senate staffer (Blumenthal’s older brother Richard became a U.S. senator from Connecticut in 2011), and a senior leader at Massachusetts General Hospital and its corporate parent, Partners HealthCare.
Like David Brailer, the first health IT czar, Blumenthal was an interesting choice for the ONC leadership job. Although he had done some fine policy research on health IT, “I knew almost nothing about information technology,” he said. “I often think, in the land of the blind, the one-eyed person is king, and I was the one-eyed person.” This, of course, is false modesty: the Obama administration needed someone with thick skin and deft political skill at the helm of ONC to ensure that the $30 billion was well spent. It did not need someone fluent in XML.
As ONC director, Blumenthal’s job was to breathe life into the HITECH and Meaningful Use programs. When I told Blumenthal that his predecessor, Brailer, had called these initiatives “a Frankenstein,” Blumenthal paused, then chose his words carefully.
“I have great respect for David, and I consider him a good friend,” Blumenthal said, flexing all his diplomacy muscles, “but I firmly disagree with him. I don’t think we would have gotten this process launched for years without these programs. You just can’t ask people to make multibillion-dollar investments in things that have no short-term return on investment.”
Blumenthal is particularly proud of the major bump in IT adoption that began during his tenure at ONC. The penetration of electronic health records in American clinics and hospitals went from about 10 percent the year before he took office to about 70 percent in 2014. While Obamacare itself, with its shift toward payment for results rather than visits and procedures, might have inspired a modest uptick, few people question that the bulk of the increase can be chalked up to Blumenthal’s initiatives.29 If Job One was to digitize the American healthcare system, then Blumenthal’s plan and his tenure at ONC were overwhelmingly successful.
To be fair, Blumenthal may well have had the easiest task of the five ONC directors, in that he had billions of dollars to dole out and, at least at first, relatively little opposition. He was also terrific at his job. “David had a combination of extraordinary vision, wonderful people around him, and money,” said John Halamka, the microchip-equipped Beth Israel CIO. The first phase of Meaningful Use (dubbed Stage 1), which was planned during and implemented at the end of Blumenthal’s tenure, was designed to be ambitious but achievable: its goal was to ensure that people were actually using the computers whose purchases were subsidized with federal dollars. “It really was a brilliant construct,” Halamka added. “I don’t know anyone in the industry who doesn’t think that Stage 1 was a great thing.”
Today, the ONC is mired in controversy, particularly over Stage 2 of Meaningful Use, which was implemented after Blumenthal left office. More generally, ONC has been hit with the “big government” trope by the Fox News/Tea Party crowd. Perhaps this shouldn’t have surprised an old pro like Blumenthal, but it did. “I figured information technology was a pretty benign, white-hat kind of thing, but not everybody thought that way,” he said.
I asked him how he explained this. “Whenever a lot of money is made available by our government for anything,” he said, “there will always be a paranoid group that assumes it was done because of corrupt and nefarious purposes. The IT movement went—almost overnight—from being a victim, an underresourced savior for everything, to being bloated, industry-dominated, dangerous, and overly favored. It was very dramatic.”
Even if one discounts the “government can’t do anything right” argument, legitimate concerns have been raised about Meaningful Use’s evolution from Stage 1 to Stage 2. Stage 1, which was rolled out in 2011–2012 (just as Blumenthal was leaving ONC), was designed to ensure that people were actually using their electronic health records, and that data were being recorded electronically and moved around to support clinical care. The requirements for Stage 1 were real but achievable, for both the EHR vendors and the frontline doctors and hospitals. They included things like providing clinical summaries to patients within three days of a hospitalization and transmitting a decent proportion of prescriptions electronically. That was precisely how Blumenthal planned it: to use Meaningful Use to gently raise the bar without having the rules inhibit adoption.
Stage 2, which was developed under Blumenthal’s successor, Farzad Mostashari, and rolled out in 2014–2015, upped the ante considerably—in keeping with Congress’s mandate. It required hospitals and physicians’ offices to meet 17 “core objectives” (with no exceptions) in order to receive incentive payments. And the objectives were far more aggressive. Rather than Stage 1’s requirement to implement a single decision support rule (like a vaccination reminder or an alert to consider sepsis in a hospitalized patient with a high fever), the requirement was now to implement five of them.
If Stage 2 had simply raised the requirement bar, it would not have been terribly controversial. Rather, what turned it into an object of considerable scorn was the fact that many of the new mandates depended on a clinical ecosystem and healthcare culture that did not yet exist. Take, for example, a new requirement that more than 5 percent of patients “view, download, and transmit” (VDT) their electronic medical information to “a third party,” such as a subspecialist using a different EHR or an insurance company. To comply with VDT, not only did the vendors need to reengineer their patient portals and the hospitals and clinics revamp their work flows, but providers now became responsible for ensuring that their patients were doing something with their newly downloaded data. I tried explaining the view, download, and transmit concept to my 78-year-old mother in Boca Raton, Florida, and didn’t get far. “Is this like your dad’s arrhythmia monitor?” she asked, referring to the device that beams my father’s heart rhythm to his cardiologist’s office every morning. Not bad, I thought, but that wouldn’t meet the requirement, since the heart monitor doesn’t count as an electronic health record. (She does get partial credit: the cardiologist probably counts as a third party.) I asked her if her concierge physician had a patient portal. “I think so, but I’ve never used it,” she said. She’s a lovely person, but she would not count as a VDT success story.
Take another requirement: that hospitals transmit discharge summaries to other facilities electronically. The most common type of facility-to-facility transition in the world of American hospitals involves patients who are discharged to nursing homes. But very few nursing homes are currently computerized (they weren’t included in the HITECH incentive program). Using a familiar analogy, Halamka explained the problem: “To make me accountable for faxing when no one else has a fax machine is not exactly a great policy.”
Stuck in this electronic Catch-22, some hospitals are going to fantastic (in both senses of the word) lengths to meet the Meaningful Use requirements. I learned that some large medical centers now receive hundreds of electronic discharge summaries each month from smaller hospitals. Sounds good, right? The problem is that the summaries (Halamka calls them “spam documents”) are of patients who have no chance of ever showing up at the receiving facility. They’re being transmitted just so the sending hospital can check a box on its Stage 2 scorecard.
John Halamka sees life through the eyes of a CIO at a large academic medical center, so it’s not surprising that he and his fellow CIOs would be unhappy with the burden and expense of meeting the Stage 2 requirements. Ditto the IT vendors. But it is harder to write off the sentiments of Christine Sinsky, the primary care internist who is struggling to survive each day in her Dubuque, Iowa, practice.
Sinsky, who has also provided testimony (as “the real doctor”) to several ONC policy committees, described how many of the ideas that seem reasonable enough when they’re being tossed around an inside-the-Beltway conference room simply don’t work in real life. “All the things in Meaningful Use were well meaning but reflected a limited, monolithic view of what practice is, with an idealized, futuristic medical record as the vehicle,” she said. “But that’s not what we have, and so we on the front lines get stuck trying to practice under the weight of those fantasies.”
Take one particular Stage 2 criterion (Core Objective 13), which requires Sinsky to give educational resources (handouts, mostly) to 10 percent of her patients, prompted by her EHR. “The way it’s designed is not aligned with the way work actually happens,” she said. Observing her in her Iowa practice, I saw what she meant. With the care of a wine collector, over the years she has assembled tons of terrific educational materials, which sit in stacks on her office shelves. As she sees patients with plantar fasciitis, diabetes, or arthritis, she hands many of them an appropriate pamphlet, often spending a moment to point out its highlights. It’s a system that works.
But, as far as Meaningful Use Stage 2, Core Objective 13 is concerned, none of it counts. “I suppose if I had an inventory of all my paper handouts and there was a computer program that matched those diagnoses, it could happen. But that’s totally absurd,” she said.
Sinsky raised this issue with her contacts at ONC: Would it be okay, she asked, if she created an electronic spreadsheet listing the top 50 handouts, and ticked off a box each time she gave one out? “They said no,” she told me, “because that would be just documenting that you gave the handout, but the computer wouldn’t be prompting you to give the handout. To me, this is like some riddle or puzzle, and,” she paused, “life is hard enough. Why are we making it so much harder?”
Complaints like these—the program is now commonly referred to by clinicians and CIOs as “Meaningless Abuse”—might have swayed David Blumenthal, the consummate mediator, but his successor at ONC, Farzad Mostashari, is a different kind of guy. Where Blumenthal is diplomatic and courtly, Mostashari is flamboyant and passionate. “A shaved-head, bow-tied bundle of enthusiasm, he radiates a good-salesman vibe, fist-bumping and high-fiving through conversations,” is how Mostashari was described in a 2012 profile. After moving from his birthplace of Iran to upstate New York as a teenager, he received a master’s degree in public health from Harvard and a medical degree from Yale, but chose not to pursue clinical practice. Instead, he went into public health and epidemiology. His worldview was shaped by his years in the New York City Health Department working under Thomas Frieden (now CDC director) and Mayor Michael Bloomberg, a department known for envelope-pushing activism. “We knew what we believed in and were not shy about advocating for it,” he told me.
In 2009, Mostashari left New York and became Blumenthal’s first lieutenant at ONC. The energy of the two workplaces could not have been more different. “If you want to go to war, you go to war with Tom Frieden,” he laughs. “If you want to stay out of war, you go with Dave Blumenthal.”
After taking the reins of ONC from Blumenthal in 2011, Mostashari struggled to find his own voice. Was he more Blumenthal or Frieden, consensus builder or china-shop bull? “In my first few meetings,” he told me, “people were saying stuff, but I felt like I should bite my tongue. I wrote a note to myself on the back of a 3×5 card, ‘Welcome to the federal government. Check your passion at the door.’”
“And then I said, ‘Fuck it! I just can’t do this.’” At that moment, he became Farzad Unplugged, and his particular passion was for moving health IT aggressively into community and public health, which meant pushing hard to link people and systems, even if everybody complained about not being ready. Several of the people I interviewed for this book, ranging from frontline clinicians to CIOs, praised Mostashari for his zeal and motives, but criticized him for his stubbornness—and for the fact that this nonclinician’s activism drove him deep into the weeds of clinical practice.
Even senior ONC staffers, while not endorsing Brailer’s “Frankenstein” label for Meaningful Use, admit that the program has gotten out of hand. Jacob Reider, the deputy national coordinator at ONC, has had a varied career as a family physician and a software developer.30 During his four years at ONC, he saw the office evolve from a sleepy bureaucratic backwater into a DC juggernaut. “I think there were things done in regulation that perhaps were enthusiastic, but those can be undone,” he said, with delicious understatement. “We are in the process of undoing some of these enthusiastic components.” This is something you don’t hear in Washington every day—the second in command at a large federal agency confessing that his organization is off course.
The hardest part, Reider admits, is getting his own people to chill out. After all, the organization’s culture was cemented in the days when ONC had piles of money to give out. But those days have passed. “I’m trying to constrain well-meaning staff who were hired to do A, B, C, D, E, F, and G and get them to focus on A and B,” he said about life today at ONC.
I asked David Brailer, the first ONC director, whether his old office might naturally pull back now that the HITECH money—its blood supply—is gone. His answer was a categorical “no.” “Bureaucracies don’t retrench,” he said. “When a bureaucracy that starts as the Candy Man runs out of candy, it goes dark and turns into Regulatory Man.” Brailer warned that if ONC isn’t forced to scale back, it will be a major obstacle to creating a flexible, organic, innovative, and responsive health IT sector. If it stays on its current course, he worries, “we’ve created another case of ‘I do what the government tells me to do.’”
Those who think that Stage 2 was a bridge too far will really hate the Stage 3 regulations, which are due to roll out sometime around 2017—the proposed rules are tougher, more ambitious, and more prescriptive. They also have the fingerprints of special interests—not so much the corporate leviathan types as the don’t forget us variety—all over them. Halamka offered an example of the problem, this one from Stage 2. “One of the standards is that people with vision problems should be able to transmit their health information,” he said. “I’ve got glaucoma. I’m all for people with vision problems. But now I have to put my most talented staff on this problem,” even before sorting out the basics of transmitting information in the first place, not to mention being sure that the EHR is usable and that kids no longer receive 39-fold overdoses of antibiotics.
Not only has Meaningful Use diverted the focus of CIOs in hospitals and physicians in clinics, but it has also consumed the bandwidth of the vendor community. “It would be great if Epic were able to update its basic architecture to a modern, Web-native platform,” said a frustrated Halamka. “But they’ve spent the last three years creating EHRs for blind people and making sure patients can download their smoking status in the appropriate computer language and then transmit it to nowhere.”
The vendors are careful when discussing ONC policies, since they have been the beneficiaries of much of the HITECH windfall, and, if you’re a multibillion-dollar company in a regulated industry, it’s smart to err on the charitable side when discussing your government. But they too have deep concerns. Carl Dvorak, Epic’s president, believes that the HITECH money was an important catalyst for IT adoption. No surprise there. However, he told me, “Government is an inefficient heavyweight to accomplish things like this. If Meaningful Use becomes a permanent lever for unfunded mandates on healthcare, I think it’ll turn out to have been a bad thing.”
Utter the phrase “Meaningful Use” in a room full of chief information officers and you’ll hear groans. But say “HIPAA” (shorthand for the 1996 act aimed at protecting patient privacy) and you’ll hear the sounds of terror. “This is the number one crazy-making issue for CIOs,” said Halamka. “I spend 50 percent of my time on it. Not on, ‘How can I create innovative mobile devices for doctors?’ Or, ‘How can we engage patients and families with new IT tools?’ Instead, it’s, ‘How can I prevent your iPhone from downloading a piece of personal health information should you lose your phone?’”
Halamka knows whereof he speaks. One of the physicians at his hospital recently bought a Mac laptop, plugged it in, and synced his e-mail. He left his office for a meeting, and when he returned, the laptop had vanished. Hospital security quickly identified a known felon from the video footage, and the police found him at his skid row apartment and arrested him. However, the laptop was gone. “Now, what is the likelihood that this drug fiend stole the laptop because he had healthcare identity theft in mind?” asked Halamka. “That would be zero.”
As of this writing, the case has cost Beth Israel more than $500,000 in legal fees, forensic work, and investigations, and it isn’t over. It will ultimately culminate in a settlement agreement between the hospital and the attorney general’s office, “where we basically say, ‘It wasn’t our fault, but here’s a set of actions Beth Israel will put in place so that no doctor is ever allowed again to bring a device into our environment and put patient data on it.’”
As the case unfolded, Halamka told his hospital’s board of directors that plugging every hole in a dike that includes 6,000 staff members and 3 million patients will take three years, $5 million a year, and 14 new staff members. Under the threat of multimillion-dollar HIPAA fines, Beth Israel—and every other healthcare facility—has little choice but to approve such plans. It did.
But it’s not just the fines and the dollars that bother Halamka and his fellow CIOs. It’s the impact on clinical care and on culture. “We have to balance the desires of the vast majority of patients, who want their data shared, with the small minority who don’t. My daughter is 21 and puts her relationship status on Facebook. My experience is that it’s a very small percentage of the population that is convinced that sharing their allergy list is going to cost them a loss of standing in the community.” What’s coming: stronger passwords with more frequent and annoying changes, new kinds of biometric identification, and a variety of other roadblocks to the free flow of information.
How absurd have things gotten? An August 2014 article in the New York Times described how pediatricians and obstetricians around the country are being forced to take down kids’ pictures from their office corkboards—pictures sent in by the proud and delighted parents—because of the fear that pinning them up might be exposing protected health information. A spokesperson for the Office for Civil Rights of the Department of Health and Human Services confirmed that such displays are, in fact, a violation of HIPAA. Really.
When HIPAA became law, there were virtually no electronic health records, no patient portals, no smartphones, and no hope of ubiquitous connectivity. It was the year Google was invented; Facebook was still eight years away. How does HIPAA fit in today? This is a hard question to answer, made harder by nearly weekly announcements of hacker intrusions into the records stored by everyone from Walgreens to hospitals. One thing seems clear, though: levying multimillion-dollar fines for security breaches on hospitals that are struggling to get by on razor-thin margins can’t be the right answer. As with Meaningful Use, the government’s “enthusiastic” regulations are creating unintended obstacles to the larger goals of improving health and healthcare.
Since we’re talking about government programs, you can be certain that while many people criticize Meaningful Use and HIPAA for being too much and too rigid, others criticize the ONC for being too lax in certain areas. The two biggies are usability (the ease of use and learnability of the IT system) and interoperability (common standards that allow different EHR systems to connect with each other).
Blumenthal agrees that today’s electronic health records could be far more usable, but when he tried to convert that concern into policy during his tenure as ONC director, he came to believe that judging usability was like Justice Potter Stewart’s “I know it when I see it” take on pornography. “We could not get any experts to say they could measure usability in a reproducible, valid way,” said Blumenthal, “a way we could stand behind from a legal standpoint.” While this issue continues to be debated, Halamka and others believe that the market is now mature enough for usability to take care of itself. With today’s high rate of EHR adoption, Halamka argues, the vendors will compete on usability, and the best products will win. As proof, he is piloting a cloud-based system built by athenahealth in Beth Israel’s extensive ambulatory clinics, a system known for its emphasis on usability (I’ll have more to say about this company later).
On this one, I side with those who believe that government should keep its nose out. Imagine if the government tried to design the look and feel of your smartphone or your computer’s desktop—well, enough said. I do, however, support a proposal to create a federal health IT safety center that can collect and analyze reports of dangerous IT interfaces (like the mg versus mg/kg Septra confusion that nearly killed Pablo Garcia) and take appropriate action. And federal support for a nonpartisan organization that grades the usability of different systems based on standard criteria—that might work. But as for the government dictating standards for fonts, colors, and clicks, well, thanks, but no thanks.
Interoperability is a different matter. Interoperability is just the kind of thing government intervention was designed for, since it is a powerful public good that the private market will not automatically create. Why is it so important? Think about your cell phone: your iPhone can call your friend’s Samsung without a hiccup, even if your service is with AT&T and your friend’s is with Verizon. The same is true with your Web browser: whether you like Safari, Chrome, or Firefox for its look or features, all of them can get you onto the Internet just fine.
In the EHR world, just think how great it would be to have an interoperable system. We’d no longer need a paper airplane to get crucial patient information from one hospital to another. The costs of switching from a crummy EHR to a better one would plummet, since the patient data stored in the old system would be easily transferrable to the new one. A world of innovators (the folks who are currently writing apps for your iPhone and Android) would be freed up to create programs to help diabetic patients or families of patients with ALS manage their care—and these would sync seamlessly with existing EHRs.
On interoperability, Blumenthal defends the ONC’s early prioritization of adoption over interoperability. “I had the basic feeling that you had to ‘operate’ before you could ‘interoperate.’ And you couldn’t create a business case for interoperability,” at least at first. Today, while the market for interoperability has gotten a bit stronger, he and I both doubt that the same business case that will drive usability will also drive interoperability. This one needs an assist from Uncle Sam.
While it would be great to have total interoperability tomorrow, it will take some time, even if the ONC puts its shoulder behind it, as it now seems to be doing with its October 2014 proposal for standardized APIs. Not only are there political obstacles to overcome (put in place mostly by vendors and healthcare systems that remain reluctant to share, as you’ll see in the next chapter), but the kinds of people involved in the nitty-gritty work of interoperability do not make for a speedy process. Said Halamka, “You know, there are forest people and there are tree people. Standards folks are, by necessity, bark people. They’ll spend a day debating the relative merits of an ampersand or a semicolon.”
There are those who believe that government should stay out of health IT altogether: it can only muck things up. I disagree. First of all, no one else can enforce public goods like interoperability and security—the market just won’t do it. Second, the HITECH investment did create an obligation for the government to ensure that the $30 billion has been well spent. Third, even without HITECH, Medicare and Medicaid pay for half the healthcare in the United States. Just as Walmart can dictate how its suppliers behave, so too does the government deserve a seat at this particular table.
Since we live in an era with deep skepticism of any government action, it’s also important to place the controversy over Meaningful Use and HIPAA in context. I asked MIT’s Andy McAfee, a leading authority on computer-enabled transformation of industries, how badly federal oversight distorts digital markets through regulation. “The existence of any 800-pound gorilla is going to distort, especially when it’s got the power to throw you in jail or fine you,” he said. “At the same time, one of the favorite reasons for inaction I hear is, ‘Yeah. But we’re a regulated industry.’ The regulations are going to change the path forward and maybe slow it down, but what they’re not going to do is stop the legitimate innovators from doing their stuff.”
Halamka’s advice to Karen DeSalvo, the current ONC director, seems right to me. “Stop the treadmill,” he told her. “Declare victory for Meaningful Use. We’ve got all these people who are suffering fatigue, who just need time to catch up. Standards need time to evolve.” DeSalvo appears to be listening (“We’re taking a deep breath,” she told me), but voluntarily shrinking one’s own bureaucracy and power has never been among our government’s core competencies.31
When I talked to people about the impact of Meaningful Use and HITECH, there was one more concern that came up over and over again. The higher the regulatory burden, goes the well-accepted teaching, the higher the chance of “vendor lock.” In other words, the incumbent companies—Big Steel to use one famous example, Ma Bell another—are best able to meet all the requirements (or, through their lawyers and lobbyists, influence them in their own favor). This makes it harder for nimble new entrants to come in and begin taking over a previously ignored part of the market, the pattern of disruptive innovation famously described by Clay Christensen. It was the deregulation of the airlines in the 1980s that paved the way for Southwest Airlines and JetBlue. And the relatively unencumbered world of the Internet has allowed the emergence of companies like Amazon and Airbnb. Such disruptors often sneak around the edges of a market (and sometimes the law; think Napster or Uber), and, by the time the incumbents wake up and begin trying to defend their franchise, the new service is too entrenched to take down.
When this example is applied to the world of healthcare IT, the incumbent that everyone refers to is Epic. The best example of an upstart company trying to take it on is athenahealth. Their stories are so compelling, and their leaders so unusual, that they deserve a chapter of their own.
29 Another measure of HITECH’s reach: as of June 2014, some 403,000 physicians (75 percent of those eligible) and 4,500 hospitals (92 percent of those eligible) had received incentive payments for meeting some or all of the adoption criteria.
30 Reider stepped down from his post in October 2014, a few months after our interview.
31 DeSalvo was named acting assistant secretary of the U.S. Department of Health and Human Services in October 2014, focusing on the federal response to Ebola. Although the initial announcement stated that she was leaving the Office of the National Coordinator, a subsequent press release stated that she would continue her leadership at ONC. In any case, many observers saw this change as evidence of ONC’s waning influence in Washington.