The
U.S. government claimed that turning American medical charts into electronic
records would make health care better, safer, and cheaper. Ten years and $36
billion later, the system is an unholy mess. Inside a digital revolution that
took a bad turn.
By Fred
Schulte and Erika Fry,
Fortune MARCH 18, 2019
The
pain radiated from the top of Annette Monachelli’s head, and it got worse when
she changed positions. It didn’t feel like her usual migraine. The 47-year-old
Vermont attorney turned innkeeper visited her local doctor at the Stowe Family
Practice twice about the problem in late November 2012, but got little relief.
Two
months later, Monachelli was dead of a brain aneurysm, a condition that,
despite the symptoms and the appointments, had never been tested for or
diagnosed until she turned up in the emergency room days before her death.
Monachelli’s
husband sued Stowe, the federally qualified health center the physician worked
for. Owen Foster, a newly hired assistant U.S. attorney with the District of
Vermont, was assigned to defend the government. Though it looked to be a
standard medical malpractice case, Foster was on the cusp of discovering
something much bigger — what his boss, U.S. Attorney Christina Nolan, calls the
“frontier of health care fraud” — and prosecuting a first-of-its-kind case that
landed the largest-ever financial recovery in Vermont’s history.
5 KEY
TAKEAWAYS
Patient
harm: Electronic health records have created a host of risks to
patient safety. Alarming reports of deaths, serious injuries and near misses —
thousands of them — tied to software glitches, user errors or other system
flaws have piled up for years in government and private repositories. Yet no
central database exists to compile and study these incidents to improve safety.
Signs
of fraud: Federal officials say the software can be misused to
overcharge, a practice known as “upcoding.” Some doctors and health systems are
alleged to have overstated their use of the new technology, a potentially
enormous fraud against Medicare and Medicaid likely to take years to unravel.
Two software makers have paid a total of more than $200 million to settle fraud
allegations.
Gaps in
interoperability: Proponents of electronic health records expected a
seamless system so patients could share computerized medical histories in a
flash with doctors and hospitals anywhere in the country. That has yet to
materialize, largely because officials allowed hundreds of competing firms to
sell medical records software unable to exchange information.
Doctor
burnout: Many doctors say they spend half their day or more
clicking pulldown menus and typing rather than interacting with patients. An
emergency room doctor can be saddled with making up to 4,000 mouse clicks per
shift. This has fueled concerns about doctor burnout, which in January the
Harvard T.H. Chan School of Public Health and Massachusetts Medical Society
called a “public health crisis.”
Web of
secrets: Entrenched policies continue to keep software failures out
of public view. Vendors of electronic health records have imposed contractual
“gag clauses” that discourage buyers from speaking out about safety issues and
disastrous software installations — and some hospitals fight to withhold
records from injured patients or their families.
Foster
began with Monachelli’s medical records, which offered a puzzle. Her doctor had
considered the possibility of an aneurysm and, to rule it out, had ordered a
head scan through the clinic’s software system, the government alleged in court
filings. The test, in theory, would have caught the bleeding in Monachelli’s brain.
But the order never made it to the lab; it had never been transmitted.
The
software in question was an electronic health records system, or EHR, made by
eClinicalWorks (eCW), one of the leading sellers of record-keeping software for
physicians in America, currently used by 850,000 health professionals in the
U.S. It didn’t take long for Foster to assemble a dossier of troubling reports —
Better Business Bureau complaints, issues flagged on an eCW user board, and
legal cases filed around the country — suggesting the company’s technology
didn’t work quite the way it said it did.
Until
this point, Foster, like most Americans, knew next to nothing about electronic
medical records, but he was quickly amassing clues that eCW’s software had
major problems — some of which put patients, like Annette Monachelli, at risk.
Damning
evidence came from a whistleblower claim filed in 2011 against the company.
Brendan Delaney, a British cop turned EHR expert, was hired in 2010 by New York
City to work on the eCW implementation at Rikers Island, a jail complex that
then had more than 100,000 inmates. But soon after he was hired, Delaney
noticed scores of troubling problems with the system, which became the basis
for his lawsuit. The patient medication lists weren’t reliable; prescribed
drugs would not show up, while discontinued drugs would appear as current,
according to the complaint. The EHR would sometimes display one patient’s
medication profile accompanied by the physician’s note for a different patient,
making it easy to misdiagnose or prescribe a drug to the wrong individual.
Prescriptions, some 30,000 of them in 2010, lacked proper start and stop dates,
introducing the opportunity for under- or overmedication. The eCW system did
not reliably track lab results, concluded Delaney, who tallied 1,884 tests for
which they had never gotten outcomes.
The
District of Vermont launched an official federal investigation in 2015.
The eCW
spaghetti code was so buggy that when one glitch got fixed, another would
develop, the government found. The user interface offered a few ways to order a
lab test or diagnostic image, for example, but not all of them seemed to function.
The software would detect and warn users of dangerous drug interactions, but
unbeknownst to physicians, the alerts stopped if the drug order was customized.
“It would be like if I was driving with the radio on and the windshield wipers
going and when I hit the turn signal, the brakes suddenly didn’t work,” said
Foster.
The eCW
system also failed to use the standard drug codes and, in some instances, lab
and diagnosis codes as well, the government alleged.
The
case never got to a jury. In May 2017, eCW paid a $155 million settlement to
the government over alleged “false claims” and kickbacks — one physician made
tens of thousands of dollars — to clients who promoted its product. Despite the
record settlement, the company denied wrongdoing; eCW did not respond to
numerous requests for comment.
If
there is a kicker to this tale, it is this: The U.S. government bankrolled the
adoption of this software — and continues to pay for it. Or we should say: You
do.
Which
brings us to the strange, sad, and aggravating story that unfolds below. It is
not about one lawsuit or a piece of sloppy technology. Rather, it’s about a
trouble-prone industry that intersects, in the most personal way, with every
one of our lives. It’s about a $3.7 trillion health care system idling at the
crossroads of progress. And it’s about a slew of unintended consequences — the
surprising casualties of a big idea whose time had seemingly come.
The
Virtual Magic Bullet
Electronic
health records were supposed to do a lot: make medicine safer, bring
higher-quality care, empower patients, and yes, even save money. Boosters
heralded an age when researchers could harness the big data within to reveal
the most effective treatments for disease and sharply reduce medical errors.
Patients, in turn, would have truly portable health records, being able to
share their medical histories in a flash with doctors and hospitals anywhere in
the country — essential when life-and-death decisions are being made in the ER.
But 10
years after President Barack Obama signed a law to accelerate the digitization
of medical records — with the federal government, so far, sinking $36 billion
into the effort — America has little to show for its investment. KHN and
Fortune spoke with more than 100 physicians, patients, IT experts and
administrators, health policy leaders, attorneys, top government officials and
representatives at more than a half-dozen EHR vendors, including the CEOs of
two of the companies. The interviews reveal a tragic missed opportunity: Rather
than an electronic ecosystem of information, the nation’s thousands of EHRs
largely remain a sprawling, disconnected patchwork. Moreover, the effort has
handcuffed health providers to technology they mostly can’t stand and has
enriched and empowered the $13-billion-a-year industry that sells it.
By one
measure, certainly, the effort has achieved what it set out to do: Today, 96
percent of hospitals have adopted EHRs, up from just 9 percent in 2008. But on
most other counts, the newly installed technology has fallen well short.
Physicians complain about clumsy, unintuitive systems and the number of hours
spent clicking, typing and trying to navigate them — which is more than the
hours they spend with patients. Unlike, say, with the global network of ATMs,
the proprietary EHR systems made by more than 700 vendors routinely don’t talk
to one another, meaning that doctors still resort to transferring medical data
via fax and CD-ROM. Patients, meanwhile, still struggle to access their own
records — and, sometimes, just plain can’t.
(Nicolas Rapp/Fortune)
Instead
of reducing costs, many say, EHRs, which were originally optimized for billing
rather than for patient care, have instead made it easier to engage in
“upcoding” or bill inflation (though some say the systems also make such fraud
easier to catch).
More
gravely still, a months-long joint investigation by KHN and Fortune has found
that instead of streamlining medicine, the government’s EHR initiative has
created a host of largely unacknowledged patient safety risks. Our
investigation found that alarming reports of patient deaths, serious injuries
and near misses — thousands of them — tied to software glitches, user errors or
other flaws have piled up, largely unseen, in various government-funded and
private repositories.
Compounding
the problem are entrenched secrecy policies that continue to keep software
failures out of public view. EHR vendors often impose contractual “gag clauses”
that discourage buyers from speaking out about safety issues and disastrous
software installations — though some customers have taken to the courts to air
their grievances. Plaintiffs, moreover, say hospitals often fight to withhold
records from injured patients or their families. Indeed, two doctors who spoke
candidly about the problems they faced with EHRs later asked that their names
not be used, adding that they were forbidden by their health care organizations
to talk. Says Assistant U.S. Attorney Foster, the EHR vendors “are protected by
a shield of silence.”
Though
the software has reduced some types of clinical mistakes common in the era of
handwritten notes, Raj Ratwani, a researcher at MedStar Health in Washington,
D.C., has documented new patterns of medical errors tied to EHRs that he
believes are both perilous and preventable. “The fact that we’re not able to broadcast
that nationally and solve these issues immediately, and that another patient
somewhere else may be harmed by the very same issue — that just can’t happen,”
he said.
David
Blumenthal, who, as Obama’s national coordinator for health information technology,
was one of the architects of the EHR initiative, acknowledged to KHN and
Fortune that electronic health records “have not fulfilled their potential. I
think few would argue they have.”
The
former president has likewise singled out the effort as one of his most
disappointing, bemoaning in a January 2017 interview with Vox “the fact that
there are still just mountains of paperwork … and the doctors still have to
input stuff, and the nurses are spending all their time on all this
administrative work. We put a big slug of money into trying to encourage
everyone to digitalize, to catch up with the rest of the world … that’s been
harder than we expected.”
Seema
Verma, the current chief of the Centers for Medicare & Medicaid Services
(CMS), which oversees the EHR effort today, shudders at the billions of dollars
spent building software that doesn’t share data — an electronic bridge to
nowhere. “Providers developed their own systems that may or may not even have
worked well for them,” she told KHN and Fortune in an interview last month,
“but we didn’t think about how all these systems connect with one another. That
was the real missing piece.”
Perhaps
none of the initiative’s former boosters is quite as frustrated as former Vice
President Joe Biden. At a 2017 meeting with health care leaders in Washington,
he railed against the infuriating challenge of getting his son Beau’s medical
records from one hospital to another. “I was stunned when my son for a year was
battling stage 4 glioblastoma,” said Biden. “I couldn’t get his records. I’m
the vice president of the United States of America. … It was an absolute
nightmare. It was ridiculous, absolutely ridiculous, that we’re in
that circumstance.”
A
Bridge To Nowhere
As
Biden would tell you, the original concept was a smart one. The wave of
digitization had swept up virtually every industry, bringing both disruption
and, in most cases, greater efficiency. And perhaps none of these industries
was more deserving of digital liberation than medicine, where life-measuring
and potentially lifesaving data was locked away in paper crypts — stack upon
stack of file folders at doctors’ offices across the country.
Stowed
in steel cabinets, the records were next to useless. Nobody — particularly at
the dawn of the age of the iPhone — thought it was a good idea to leave them
that way. The problem, say critics, was in the way that policymakers set about
to transform them.
“Every
single idea was well-meaning and potentially of societal benefit, but the
combined burden of all of them hitting clinicians simultaneously made office
practice basically impossible,” said John Halamka, chief information officer at
Beth Israel Deaconess Medical Center, who served on the EHR standards committees
under both George W. Bush and Barack Obama. “In America, we have 11 minutes to
see a patient, and, you know, you’re going to be empathetic, make eye contact,
enter about 100 pieces of data, and never commit malpractice. It’s not
possible!”
KHN and
Fortune examined more than two dozen medical negligence cases that have alleged
that EHRs either contributed to injuries, had been improperly altered, or were
withheld from patients to conceal substandard care. In such cases, the suits
typically settle prior to trial with strict confidentiality pledges, so it’s
often not possible to determine the merits of the allegations. EHR vendors also
frequently have contract stipulations, known as “hold harmless clauses,” that
protect them from liability if hospitals are later sued for medical errors —
even if they relate to an issue with the technology.
But
lawsuits, like that filed by Fabian Ronisky, which do emerge from this veil,
are quite telling.
Ronisky,
according to his complaint, arrived by ambulance at Providence Saint John’s
Health Center in Santa Monica on the afternoon of March 2, 2015. For two
days, the young lawyer had been suffering from severe headaches while a
disorienting fever left him struggling to tell the 911 operator his address.
Suspecting
meningitis, a doctor at the hospital performed a spinal tap, and the next day
an infectious disease specialist typed in an order for a critical lab test — a
check of the spinal fluid for viruses, including herpes simplex — into the
hospital’s EHR.
The
multimillion-dollar system, manufactured by Epic Systems Corp. and considered
by some to be the Cadillac of medical software, had been installed at the
hospital about four months earlier. Although the order appeared on Epic’s
screen, it was not sent to the lab. It turned out, Epic’s software didn’t fully
“interface” with the lab’s software, according to a lawsuit Ronisky filed in
February 2017 in Los Angeles County Superior Court. His results and diagnosis
were delayed — by days, he claimed — during which time he suffered irreversible
brain damage from herpes encephalitis. The suit alleged the mishap delayed
doctors from giving Ronisky a drug called acyclovir that might have minimized
damage to his brain.
Epic
denied any liability or defects in its software; the company said the doctor
failed to push the right button to send the order and that the hospital, not
Epic, had configured the interface with the lab. Epic, among the nation’s
largest manufacturers of computerized health records and the leading provider
to most of America’s most elite medical centers, quietly paid $1 million to settle the suit in
July 2018, according to court records. The hospital and two doctors paid a
total of $7.5 million, and a case against a third doctor is pending trial.
Ronisky, 34, who is fighting to rebuild his life, declined to comment.
Incidents
like that which happened to Ronisky — or to Annette Monachelli, for that matter
— are surprisingly common, data show. And the back-and-forth about where the
fault lies in such cases is actually part of the problem: The systems are often
so confusing (and training on them seldom sufficient) that errors frequently
fall into a nether zone of responsibility. It can be hard to tell where human
error begins and the technological shortcomings end.
EHRs
promised to put all of a patient’s records in one place, but often that’s the
problem. Critical or time-sensitive information routinely gets buried in an
endless scroll of data, where in the rush of medical decision-making — and amid
the maze of pulldown menus — it can be missed.
Thirteen-year-old
Brooke Dilliplaine, who was severely allergic to dairy, was given a probiotic
containing milk. The two doses sent her into “complete respiratory distress”
and resulted in a collapsed lung, according to a lawsuit filed by her mother.
Rory Staunton, 12, scraped his arm in gym class and then died of sepsis after
ER doctors discharged the boy on the basis of lab results in the EHR that
weren’t complete. And then there’s the case of Thomas Eric Duncan. The
42-year-old man was sent home in 2014 from a Dallas hospital infected with
Ebola virus. Though a nurse had entered in the EHR his recent travel to Liberia,
where an Ebola epidemic was then in full swing, the doctor never saw it. Duncan
died a week later.
Many
such cases end up in court. Typically, doctors and nurses blame faulty
technology in the medical-records systems. The EHR vendors blame human error.
And meanwhile, the cases mount.
Quantros,
a private health care analytics firm, said it has logged 18,000 EHR-related
safety events from 2007 through 2018, 3 percent of which resulted in patient
harm, including seven deaths — a figure that a Quantros director said is
“drastically underreported.”
A 2016
study by The Leapfrog Group, a patient-safety watchdog based in Washington,
D.C., found that the medication-ordering function of hospital EHRs — a feature
required by the government for certification but often configured differently
in each system — failed to flag potentially harmful drug orders in 39 percent
of cases in a test simulation. In 13 percent of those cases, the mistake could
have been fatal.
The Pew
Charitable Trusts has, for the past few years, run an EHR safety project,
taking aim at issues like usability and patient matching — the process of
linking the correct medical record to the correct patient — a seemingly basic
task at which the systems, even when made by the same EHR vendor, often fail.
At some institutions, according to Pew, such matching was accurate only 50
percent of the time. Patients have discovered mistakes as well: A January survey by the
Kaiser Family Foundation found that 1 in 5 patients spotted an error in their
electronic medical records. (Kaiser Health News is an editorially independent
program of the foundation.)
(Nicolas Rapp/Fortune)
The
Joint Commission, which certifies hospitals, has sounded alarms about a number
of issues, including false alarms — which account for between 85 and 99 percent
of EHR and medical device alerts. (One study by researchers at Oregon Health
& Science University estimated that the average clinician working in the
intensive care unit may be exposed to up to 7,000 passive alerts per day.) Such
over-warning can be dangerous. From 2014 to 2018, the commission tallied 170
mostly voluntary reports of patient harm related to alarm management and alert
fatigue — the phenomenon in which health workers, so overloaded with
unnecessary warnings, ignore the occasional meaningful one. Of those 170
incidents, 101 resulted in patient deaths.
The
Pennsylvania Patient Safety Authority, an independent state agency that
collects information about adverse events and incidents, counted 775
“laboratory-test problems” related to health IT from January 2016 to December
2017.
To be
sure, medical errors happened en masse in the age of paper medicine, when
hospital staffers misinterpreted a physician’s scrawl or read the wrong chart
to deadly consequence, for instance. But what is perhaps telling is how many
doctors today opt for manual workarounds to their EHRs. Aaron Zachary
Hettinger, an emergency medicine physician with MedStar Health in Washington,
D.C., said that when he and fellow clinicians need to share critical patient
information, they write it on a whiteboard or on a paper towel and leave it on
their colleagues’ computer keyboards.
While
the Food and Drug Administration doesn’t mandate reporting of EHR safety events
— as it does for regulated medical devices — concerned posts have nonetheless
proliferated in the FDA MAUDE database
of adverse events, which now serves as an ad hoc bulletin board of warnings
about the various systems.
Further
complicating the picture is that health providers nearly always tailor their
one-size-fits-all EHR systems to their own specifications. Such customization
makes every one unique and often hard to compare with others — which, in turn,
makes the source of mistakes difficult to determine.
(Nicolas Rapp/Fortune)
Dr.
Martin Makary, a surgical oncologist at Johns Hopkins and the co-author of a
much-cited 2016 study that identified medical errors as the third-leading cause
of death in America, credits EHRs for some safety improvements — including
recent changes that have helped put electronic brakes on the opioid epidemic.
But, he said, “we’ve swapped one set of problems for another. We used to
struggle with handwriting and missing information. We now struggle with a lack
of visual cues to know we’re writing and ordering on the correct patient.”
Dr.
Joseph Schneider, a pediatrician at UT Southwestern Medical Center, compares
the transition we’ve made, from paper records to electronic ones, to moving
from horses to automobiles. But in this analogy, he added, “our cars have
advanced to about the 1960s. They still don’t have seat belts or air bags.”
Schneider
recalled one episode when his colleagues couldn’t understand why chunks of
their notes would inexplicably disappear. They figured out the problem weeks
later after intense study: Physicians had been inputting squiggly brackets — {}
— the use of which, unbeknownst to even vendor representatives, deleted the
text between them. (The EHR maker initially blamed the doctors, said
Schneider.)
A broad
coalition of actors, from National Nurses United to the Texas Medical
Association to leaders within the FDA, has long called for oversight on
electronic-record safety issues. Among the most outspoken is Ratwani, who
directs MedStar Health’s National Center on Human Factors in Healthcare, a 30-person
institute focused on optimizing the safety and usability of medical technology.
Ratwani spent his early career in the defense industry, studying things like
the intuitiveness of information displays. When he got to MedStar in 2012, he
was stunned by “the types of [digital] interfaces being used” in health care,
he said.
In a
study published last year in the journal Health Affairs, Ratwani and colleagues
studied medication errors at three pediatric hospitals from 2012 to 2017. They
discovered that 3,243 of them were owing in part to EHR “usability issues.”
Roughly 1 in 5 of these could have resulted in patient harm, the researchers
found. “Poor interface design and poor implementations can lead to errors and
sometimes death, and that is just unbelievably bad as well as completely
fixable,” he said. “We should not have patients harmed this way.”
Using
eye-tracking technology, Ratwani has demonstrated on video just how easy it is
to make mistakes when performing basic tasks on the nation’s two leading EHR
systems. When emergency room doctors went to order Tylenol, for example, they
saw a drop-down menu listing 86 options, many of which were irrelevant for the
specified patient. They had to read the list carefully, so as not to click the
wrong dosage or form — though many do that too: In roughly 1 out of 1,000
orders, physicians accidentally select the suppository (designated “PR”) rather
than the tablet dose (“OR”), according to one estimate. That’s not an error
that will harm a patient — though other medication mix-ups can and do.
Earlier
this year, MedStar’s human-factors center launched
a website and public awareness campaign with the American
Medical Association to draw attention to such rampant mistakes — they use the
letters “EHR” as an initialism for “Errors Happen Regularly” — and to petition
Congress for action. Ratwani is pushing for a central database to track such
errors and adverse events.
Others
have turned to social media to vent. Dr. Mark Friedberg, a health-policy
researcher with the Rand Corp. who is also a practicing primary care physician,
champions the Twitter hashtag #EHRbuglist to encourage fellow health care
workers to air their pain points. And last month, a scathing Epic parody
account cropped up on Twitter, earning more than 8,000 followers in its first
five days. Its maiden tweet, written in the mock voice of an Epic overlord,
read: “I once saw a doctor make eye contact with a patient. This horror must
stop.”
As much
as EHR systems are blamed for sins of commission, it is often the sins of
omission that trip up users even more.
3,243
Number of medication
errors linked to EHR-usability issues at three pediatric hospitals from 2012 to
2017, according to a Health Affairs study
Consider
the case of Lynne Chauvin, who worked as a medical assistant at Ochsner Health
System, in Louisiana. In a still-pending 2015 lawsuit, Chauvin alleges that
Epic’s software failed to fire a critical medication warning; Chauvin suffered
from conditions that heightened her risk for blood clots, and though that
history was documented in her records, she was treated with drugs that
restricted blood flow after a heart procedure at the hospital. She developed
gangrene, which led to the amputation of her lower legs and forearm. (Ochsner
Health System said that while it cannot comment on ongoing litigation, it
“remains committed to patient safety which we strongly believe is optimized
through the use of electronic health record technology.” Epic declined to comment.)
Echoing
the complaints of many doctors, the suit argues that Epic software “is
extremely complicated to view and understand,” owing to “significant repetition
of data.” Chauvin said that her medical bills have topped $1 million and that
she is permanently disabled. Her husband, Richard, has become her primary
caregiver and had to retire early from his job with the city of Kenner to care
for his wife, according to the suit. Each party declined to comment.
An
Epidemic Of Burnout
The
numbing repetition, the box-ticking and the endless searching on pulldown menus
are all part of what Ratwani called the “cognitive burden” that’s wearing out
today’s physicians and driving increasing numbers into early retirement.
In
recent years, “physician burnout” has skyrocketed to the top of the agenda in
medicine. A 2018 Merritt Hawkins survey found a staggering 78 percent of
doctors suffered symptoms of burnout, and in January the Harvard School of
Public Health and other institutions deemed it a “public health crisis.”
One of
the co-authors of the Harvard study, Ashish Jha, pinned much of the blame on
“the growth in poorly designed digital health records … that [have] required that physicians spend more and more time on
tasks that don’t directly benefit patients.”
Few
would deny that the swift digitization of America’s medical system has been
transformative. With EHRs now nearly universal, the face and feel of medicine
has changed. The doctor is now typing away, making more eye contact with the
computer screen, perhaps, than with the patient. Patients don’t like that
dynamic; for doctors, whose days increasingly begin and end with such fleeting
encounters, the effect can be downright deadening.
“You’re
sitting in front of a patient, and there are so many things you have to do, and
you only have so much time to do it in — seven to 11 minutes, probably — so
when do you really listen?” asked John-Henry Pfifferling, a medical
anthropologist who counsels physicians suffering from burnout. “If you go into
medicine because you care about interacting, and then you’re just a tool, it’s
dehumanizing,” said Pfifferling, who has seen many physicians leave medicine
over the shift to electronic records. “It’s a disaster,” he said.
Beyond
complicating the physician-patient relationship, EHRs have in some ways made
practicing medicine harder, said Dr. Hal Baker, a physician and the chief
information officer at WellSpan, a Pennsylvania hospital system. “Physicians
have to cognitively switch between focusing on the record and focusing on the
patient,” he said. He points out how unusual — and potentially dangerous — this
is: “Texting while you’re driving is not a good idea. And I have yet to see the
CEO who, while running a board meeting, takes minutes, and certainly I’ve never
heard of a judge who, during the trial, would also be the court stenographer.
But in medicine … we’ve
asked the physician to move from writing in pen to [entering a computer]
record, and it’s a pretty complicated interface.”
5.9 HOURS
Average time (out of an
11.4-hour workday) doctors spend on EHRs, compared with 5.1 hours spent with
patients, according to a 2017 study in the Annals of Family Medicine
Even if
docs may be at the keyboard during visits, they report having to spend hours
more outside that time — at lunch, late at night — in order to finish notes and
keep up with electronic paperwork (sending referrals, corresponding with
patients, resolving coding issues). That’s right. EHRs didn’t take away
paperwork; the systems just moved it online. And there’s a lot of it: 44
percent of the roughly six hours a physician spends on the EHR each day is
focused on clerical and administrative tasks, like billing and coding,
according to a 2017 Annals of Family Medicine study.
For all
that so-called pajama time — the average physician logs 1.4 hours per day on
the EHR after work — they don’t get a cent.
Many
doctors do recognize the value in the technology: 60 percent of participants in
Stanford Medicine’s 2018 National Physician Poll said EHRs had led to improved
patient care. At the same time, about as many (59 percent) said EHRs needed a
“complete overhaul” and that the systems had detracted from their professional
satisfaction (54 percent) as well as from their clinical effectiveness (49
percent).
In
preliminary studies, Ratwani has found that doctors have a typical
physiological reaction to using an EHR: stress. When he and his team shadow
clinicians on the job, they use a range of sensors to monitor the doctors’
heart rate and other vital signs over the course of their shift. The
physicians’ heart rates will spike — as high as 160 beats per minute — on two
sorts of occasions: when they are interacting with patients and when they’re
using the EHR.
4,000
Approximate number of
computer clicks an ER doctor makes over the course of a single shift, according
to an American Journal of Emergency Medicine study
“Everything
is so cumbersome,” said Dr. Karla Dick, a family medicine physician in
Arlington, Texas. “It’s slow compared to a paper chart. You’re having to click
and zoom in and zoom out to look for stuff.” With all the zooming in and out,
she explained, it’s easy to end up in the wrong record. “I can’t tell you how
many times I’ve had to cancel an order because I was in the wrong chart.”
Among
the daily frustrations for one emergency room physician in Rhode Island is
ordering ibuprofen, a seemingly simple task that now requires many rounds of
mouse clicking. Every time she prescribes the basic painkiller for a female
patient, whether that patient is 9 or 68 years old, the prescription is blocked
by a pop-up alert warning her that it may be dangerous to give the drug to a
pregnant woman. The physician, whose institution does not allow her to comment
on the systems, must then override the warning with yet more clicks. “That’s
just the tiniest tip of the iceberg,” she said.
What
worries the doctor most is the ease with which diligent, well-meaning
physicians can make serious medical errors. She noted that the average ER doc
will make 4,000 mouse clicks over the course of a shift, and that the odds of
doing anything 4,000 times without an error is small. “The interfaces are just
so confusing and clunky,” she added. “They invite error … it’s not a negligence issue. This is a poor tool issue.”
Many of
the EHR makers acknowledge physician burnout is real and say they’re doing what
they can to lessen the burden and enhance user experience. Dr. Sam Butler, a
pulmonary critical care specialist who started working at Epic in 2001, leads
those efforts at the Wisconsin-based company. When doctors get more than 100
messages per week in their in-basket (akin to an email inbox), there’s a higher
likelihood of burnout. Butler’s team has also analyzed doctors’ electronic
notes — they’re twice as long as they were nine years ago, and three to four times
as long as notes in the rest of the world. He said Epic uses such insights to
improve the client experience. But coming up with fixes is difficult because
doctors “have different viewpoints on everything,” he said. (KHN and Fortune
made multiple requests to interview Epic CEO Judy Faulkner, but the company
declined to make her available. In a trade interview in February, however,
Faulkner said that EHRs were unfairly blamed for physician burnout and cited a
study suggesting that there’s little correlation between burnout and EHR
satisfaction. Executives at other vendors noted that they’re aware of usability
issues and that they’re working on addressing them.)
“It’s
not that we’re a bunch of Luddites who don’t know how to use technology,” said
the Rhode Island ER doctor. “I have an iPhone and a computer and they work the
way they’re supposed to work, and then we’re given these incredibly cumbersome
and error-prone tools. This is something the government mandated. There really
wasn’t the time to let the cream rise to the top; everyone had to jump in and
pick something that worked and spend tens of millions of dollars on a system
that is slowly killing us.”
$36
Billion And Change
The
effort to digitize America’s health records got its biggest push in a very low
moment: the financial crisis of 2008. In early December of that year, Obama,
barely four weeks after his election, pitched an ambitious economic recovery plan.
“We will make sure that every doctor’s office and hospital in this country is
using cutting-edge technology and electronic medical records so that we can cut
red tape, prevent medical mistakes and help save billions of dollars each
year,” he said in a radio address.
The
idea had already been a fashionable one in Washington. Former House Speaker
Newt Gingrich was fond of saying it was easier to track a FedEx package than
one’s medical records. Obama’s predecessor, President George W. Bush, had also
pursued the idea of wiring up the country’s health system. He didn’t commit
much money, but Bush did create an agency to do the job: the Office of the
National Coordinator (ONC).
In the
depths of recession, the EHR conceit looked like a shovel-ready project that
only the paper lobby could hate. In February 2009, legislators passed the
HITECH Act, which carved out a hefty chunk of the massive stimulus package for
health information technology. The goal was not just to get hospitals and
doctors to buy EHRs, but rather to get them using them in a way that would
drive better care. So lawmakers devised a carrot-and-stick approach: Physicians
would qualify for federal subsidies (a sum of up to nearly $64,000 over a
period of years) only if they were “meaningful users” of a government-certified
system. Vendors, for their part, had to develop systems that met the
government’s requirements.
They
didn’t have much time, though. The need to stimulate the economy, which meant
getting providers to adopt EHRs quickly, “presented a tremendous conundrum,”
said Farzad Mostashari, who joined the ONC as deputy director in 2009 and
became its leader in 2011: The ideal — creating a useful, interoperable,
nationwide records system — was “utterly infeasible to get to in a short time
frame.”
That
didn’t stop the federal planners from pursuing their grand ambitions. Everyone
had big ideas for the EHRs. The FDA wanted the systems to track unique device
identifiers for medical implants, the Centers for Disease Control and
Prevention wanted them to support disease surveillance, CMS wanted them to
include quality metrics and so on. “We had all the right ideas that were
discussed and hashed out by the committee,” said Mostashari, “but they
were all of the right ideas.”
Not
everyone agreed, though, that they were the right ideas. Before long,
“meaningful use” became pejorative shorthand to many for a burdensome
government program — making doctors do things like check a box indicating a
patient’s smoking status each and every visit.
The EHR
vendor community, then a scrappy $2 billion industry, griped at the litany of
requirements but stood to gain so much from the government’s $36 billion
injection that it jumped in line. As Rusty Frantz, CEO of EHR vendor NextGen
Healthcare, put it: “The industry was like, ‘I’ve got this check dangling in
front of me, and I have to check these boxes to get there, and so I’m going to
do that.’”
Halamka,
who was an enthusiastic backer of the initiative in both the Bush and Obama
administrations, blames the pressure for a speedy launch as much as the
excessive wish list. “To go from a regulation to a highly usable product that
is in the hands of doctors in 18 months, that’s too fast,” he said. “It’s like
asking nine women to have a baby in a month.”
Several
of those who worked on the project admit the rollout was not as easy or
seamless as they’d anticipated, but they contend that was never the point.
Aneesh Chopra, appointed by Obama in 2009 as the nation’s first chief technology
officer, called the spending a “down payment” on a vision to fundamentally
change American medicine — creating a digital infrastructure to support new
ways to pay for health services based on their quality and outcomes.
Dr. Bob
Kocher, a physician and star investor with venture capital firm Venrock, who
served in the Obama administration from 2009 to 2011 as a health and economic
policy adviser, not only defends the rollout then but also disputes the notion
that the government initiative has been a failure at all. “EHRs have totally
lived up to the hype and expectations,” he said, emphasizing that they also
serve as a technology foundation to support innovation on everything from
patients accessing their medical records on a smartphone to AI-driven medical
sleuthing. Others note the systems’ value in aggregating medical data in ways
that were never possible with paper — helping, for example, to figure out that
contaminated water was poisoning children in Flint, Mich.
But
Rusty Frantz heard a far different message about EHRs — and, more important, it
was coming from his own customers.
The
Stanford-trained engineer, who in 2015 became CEO of NextGen, a
$500-million-a-year EHR heavyweight in the physician-office market, learned the
hard way about how his product was being viewed. As he stood at the podium at
his first meeting with thousands of NextGen customers at Las Vegas’ Mandalay
Bay Resort, just four months after getting the job, he told KHN and Fortune, “People
were lining up at the microphones to yell at us: ‘We weren’t delivering stable
software! The executive team was inaccessible! The service experience was
terrible!’ ” (He
now refers to the event as “Festivus: the airing of the grievances.”)
Frantz
had bounced around the health care industry for much of his career, and from
the nearby perch of a medical device company, he watched the EHR incentive
bonanza with a mix of envy and slack-jawed awe. “The industry was moving along
in a natural Darwinist way, and then along came the stimulus,” said Frantz, who
blames the government’s ham-handed approach to regulation. “The software got
slammed in, and the software wasn’t implemented in a way that supported care,”
he said. “It was installed in a way that supported stimulus. This company, we
were complicit in it, too.”
Even
that may be a generous description. KHN and Fortune found a trail of lawsuits
against the company, stretching from White Sulphur Springs, Mont., to
Neillsville, Wis. Mary Rutan Hospital in Bellefontaine, Ohio, sued NextGen
(formerly called Quality Systems) in federal court in 2013, arguing that it
experienced hundreds of problems with the “materially defective” software the
company had installed in 2011.
A
consultant hired by the hospital to evaluate the NextGen system, whose 60-page report was
submitted to the court, identified “many functional defects” that he said
rendered the software “unfit for its intended purpose.” Some patient information
was not accurately recorded, which had the potential, the consultant wrote, “to
create major patient care risk which could lead to, at a minimum,
inconvenience, and at worst, malpractice or even death.” Glitches at Mary Rutan
included incidents in which the software would apparently change a patient’s
gender at random or lose a doctor’s observations after an exam, the consultant
reported. The company, he found, sometimes took months to address issues: One
IT ticket, which related to a physician’s notes inexplicably deleting
themselves, reportedly took 10 months to resolve. (The consultant also noted
that similar problems appeared to be occurring at as many as a dozen other
hospitals that had installed NextGen software.)
The
Ohio hospital, which paid more than $1.5 million for its EHR system, claimed
breach of contract. NextGen responded that it disputed the claims made in the
lawsuit and that the matter was resolved in 2015 “with no findings of fact by a
court related to the allegations.” The hospital declined to comment.
At the
time, as it has been since then, NextGen’s software was certified by the
government as meeting the requirements of the stimulus program. By 2016,
NextGen had more than 19,000 customers who had received federal subsidies.
(Nicolas Rapp/Fortune)
NextGen
was subpoenaed by the Department of Justice in December 2017, months after
becoming the subject of a federal investigation led by the District of Vermont.
Frantz tells KHN and Fortune that NextGen is cooperating with the
investigation. “This company was not dishonest, but it was not effective four
years ago,” he said. Frantz also emphasized that NextGen has “rapidly evolved”
during his tenure, earning five industry awards since 2017, and that customers
have “responded very positively.”
Glen
Tullman, who until 2012 led Allscripts, another leading EHR vendor that
benefited royally from the stimulus and that has been sued by numerous unhappy
customers, admitted that the industry’s race to market took priority over all
else.
“It was
a big distraction. That was an unintended consequence of that,” Tullman said.
“All the companies were saying, This is a one-time opportunity to expand our
share, focus everything there, and then we’ll go back and fix it.” The Justice
Department has opened a civil investigation into the company, Securities and
Exchange Commission filings show. Allscripts said in an email that it cannot
comment on an ongoing investigation, but that the civil investigations by the
Department of Justice relate to businesses it acquired after the investigations
were opened.
Much of
the marketing mayhem occurred because federal officials imposed few controls
over firms scrambling to cash in on the stimulus. It was a gold rush — and any
system, it seemed, could be marketed as “federally approved.” Doctors could
shop for bargain-price software packages at Costco and Walmart’s Sam’s Club —
where eClinicalWorks sold a “turnkey” system for $11,925 — and cash in on the
government’s adoption incentives.
The
top-shelf vendors in 2009 crisscrossed the country on a “stimulus tour”like
rock groups, gigging at some 30 cities, where they offered doctors who showed
up to hear the pitch “a customized analysis” of how much money they could earn
off the government incentives. Following the same playbook used by
pharmaceutical companies, EHR sellers courted doctors at fancy dinners in ritzy
hotels. One enterprising software firm advertised a “cash for clunkers” deal
that paid $3,000 to doctors willing to trade in their current records system
for a new one. Athenahealth held “invitation only” dinners at luxury hotels to
advise doctors, among other things, how to use the stimulus to get paid more
and capture available incentives. Allscripts offered a no-money-down purchase
plan to help doctors “maximize the return on your EHR investment.” (An Athenahealth
spokesperson said the company’s “dinners were educational in nature and aimed
at helping physicians navigate the government program.” Allscripts did not
respond directly to questions about its marketing practices, but said it “is
proud of the software and services [it provides] to hundreds of thousands of
caregivers across the globe.”)
EHRs
were supposed to reduce health care costs, at least in part by preventing
duplicative tests. But as the federal government opened the stimulus tap, many
raised doubts about the promised savings. Advocates bandied about a figure of
$80 billion in cost savings even as congressional auditors were debunking
it. While the jury’s still out, there’s growing suspicion the digital
revolution may potentially raise health care costs by encouraging overbilling
and new strains of fraud and abuse.
In September
2012, following press reports suggesting that some doctors and hospitals were
using the new technology to improperly boost their fees, a practice known as
“upcoding,” then-Health and Human Services chief Kathleen Sebelius and Attorney
General Eric Holder warned the industry not
to try to “game the system.”
There’s
also growing evidence that some doctors and health systems may have overstated
their use of the new technology to secure stimulus funds, a potentially
enormous fraud against Medicare and Medicaid that likely will take many years
to unravel. In June 2017, the HHS inspector general estimated that Medicare officials
made more than $729 million in subsidy payments to hospitals and doctors
that didn’t deserve them.
Individual
states, which administer the Medicaid portion of the program, haven’t fared
much better. Audits have uncovered overpayments in 14 of 17 state programs
reviewed, totaling more than $66 million, according to inspector general
reports.
Last
month, Sen. Chuck Grassley, an Iowa Republican who chairs the Senate Finance
Committee, sharply criticized CMS for recovering only a tiny fraction of these
bogus payments, or what he termed a “spit in the ocean.”
EHR
vendors have also been accused of egregious and patient-endangering acts of
fraud as they raced to cash in on the stimulus money grab. In addition to
the U.S. government’s $155 million False Claims Act
settlement with eClinicalWorks noted above, the federal
government has reached a second settlement over similar charges against another
large vendor, Tampa-based Greenway Health. In February, that company settled with the government for
just over $57 million without denying or admitting wrongdoing. “These are cases
of corporate greed, companies that prioritized profits over everything else,”
said Christina Nolan, the U.S. attorney for the District of Vermont, whose
office led the cases. (In a response, Greenway Health did not address the
charges or the settlement but said it was “committing itself to being the
standard-bearer for quality, compliance, and transparency.”)
Tower
Of Babel
In
early 2017, Seema Verma, then the country’s newly appointed CMS administrator,
went on a listening tour. She visited doctors around the country, at big urban
practices and tiny rural clinics, and from those front-line physicians she
consistently heard one thing: They hated their electronic health records.
“Physician burnout is real,” she told KHN and Fortune. The doctors
spoke of the difficulty in getting information from other systems and providers,
and they complained about the government’s reporting requirements, which they
perceived as burdensome and not meaningful.
What
she heard then became suddenly personal one summer day in 2017, when her
husband, himself a physician, collapsed in the airport on his way home to
Indianapolis after a family vacation. For a frantic few hours, the CMS
administrator fielded phone calls from first responders and physicians — Did
she know his medical history? Did she have information that could save his
life? — and made calls to his doctors in Indiana, scrambling to piece together
his record, which should have been there in one piece. Her husband survived the
episode, but it laid bare the dysfunction and danger inherent in the existing
health information ecosystem.
The
notion that one EHR should talk to another was a key part of the original
vision for the HITECH Act, with the government calling for systems to be
eventually interoperable.
What
the framers of that vision didn’t count on were the business incentives working
against it. A free exchange of information means that patients can be treated
anywhere. And though they may not admit it, many health providers are loath to
lose their patients to a competing doctor’s office or hospital. There’s a term
for that lost revenue: “leakage.” And keeping a tight hold on patients’ medical
records is one way to prevent it.
There’s
a ton of proprietary value in that data, said Blumenthal, who now heads the
Commonwealth Fund, a philanthropy that does health research. Asking hospitals
to give it up is “like asking Amazon to share their data with Walmart,” he
said.
Blumenthal
acknowledged that he failed to grasp these perverse business dynamics and
foresee what a challenge getting the systems to talk to one another would be.
He added that forcing interoperability goals early on, when 90 percent of the
nation’s providers still didn’t have systems or data to exchange, seemed
unrealistic. “We had an expression: They had to operate before they could
interoperate,” he said.
In the
absence of true incentives for systems to communicate, the industry limped
along; some providers wired up directly to other select providers or through
regional exchanges, but the efforts were spotty. A Cerner-backed
interoperability network called CommonWell formed in 2013, but some companies,
including dominant Epic, didn’t join. (“Initially, Epic was neither invited nor
allowed to join,” said Sumit Rana, senior vice president of R&D at Epic.
Jitin Asnaani, executive director of CommonWell countered, “We made repeated
invitations to every major EHR … and numerous public and
private invitations to Epic.”)
Epic
then supported a separate effort to do much the same.
Last
spring, Verma attempted to kick-start the sharing effort and later pledged a
war on “information blocking,” threatening penalties for bad actors. She has
promised to reduce the documentation burden on physicians and end the gag
clauses that protect the EHR industry. Regarding the first effort at least,
“there was consensus that this needed to happen and that it would take the
government to push this forward,” she said. In one sign of progress last
summer, the dueling sharing initiatives of Epic and Cerner, the two largest
players in the industry, began to share with each other — though the effort is
fledgling.
When it
comes to patients, though, the real sharing too often stops. Despite federal
requirements that providers give patients their medical records in a timely
fashion, in their chosen format and at low cost (the government recommends a
flat fee of $6.50 or less), patients struggle mightily to get them. A 2017
study by researchers at Yale found that of America’s 83 top-rated hospitals,
only 53 percent offer forms that provide patients with the option to receive
their entire medical record. Fewer than half would share records via email. One
hospital charged more than $500 to release them.
Sometimes
the mere effort to access records leads to court. Jennifer De Angelis, a Tulsa
attorney, has frequently sparred with hospitals over releasing her clients’
records. She said they either attempt to charge huge sums for them or force her
to obtain a court order before releasing them. De Angelis added that she
sometimes suspects the records have been overwritten to cover up medical
mistakes.
Consider
the case of 5-year-old Uriah R. Roach, who fractured and cut his finger on Oct.
2, 2014, when it was accidentally slammed in a door at school. Five days later,
an operation to repair the damage went awry, and he suffered permanent brain
damage, apparently owing to an anesthesia problem. The Epic electronic medical
file had been accessed more than 76,000 times during the 22 days the boy was in
the hospital, and a lawsuit brought by his parents contended that numerous
entries had been “corrected, altered, modified and possibly deleted after an
unexpected outcome during the induction of anesthesia.” The hospital denied
wrongdoing. The case settled in November 2016, and the terms are confidential.
More
than a dozen other attorneys interviewed cited similar problems, especially
with gaining access to computerized “audit trails.” In several cases, court
records show, government lawyers resisted turning over electronic files from
federally run hospitals. That happened to Russell Uselton, an Oklahoma lawyer
who represented a pregnant teen admitted to the Choctaw Nation Health Care
Center in Talihina, Okla. Shelby Carshall, 18, was more than 40 weeks pregnant
at the time. Doctors failed to perform a cesarean section, and her baby was
born brain-damaged as a result, she alleged in a lawsuit filed in 2017 against
the U.S. government. The baby began having seizures at 10 hours old and
will “likely never walk, talk, eat, or otherwise live normally,” according to
pleadings in the suit. Though the federal government requires hospitals to
produce electronic health records to patients and their families, Uselton had
to obtain a court order to get the baby’s complete medical files. Government
lawyers denied any negligence in the case, which is pending.
“They
try to hide anything from you that they can hide from you,” said Uselton. “They
make it extremely difficult to get records, so expensive and hard that most
lawyers can’t take it on,” he said.
Nor, it
seems, can high-ranking federal officials. When Seema Verma’s husband was
discharged from the hospital after his summer health scare, he was handed a few
papers and a CD-ROM containing some medical images — but missing key tests and
monitoring data. Said Verma, “We left that hospital and we still don’t have his
information today.” That was nearly two years ago.
Fred Schulte: fschulte@kff.org,
@fredschulte
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