Lawsuits filed by whistleblowers, doctors, and hospitals allege EHR software used by hospitals, clinical laboratories, and medical offices may ‘pose danger to patients’
Where have all the federal incentives for meaningful use of health information technology (HIT) gone? Pathologists and clinical laboratory leaders caught up in medical error investigations are not the only healthcare providers asking this question.
Now, an ongoing investigation by Fortune and Kaiser Health News (KHN) indicates some EHR software vendors and healthcare providers were paid hundreds of millions of dollars in federal subsidies that they should not have received. Furthermore, EHRs are apparently associated with thousands of mistakes and medical errors, the Fortune and KHN investigation revealed.
In “Electronic Health Records Creating a ‘New Era’ of Health Care Fraud,” KHN wrote that “The federal government funneled billions in subsidies to software vendors who overstated or deceived the government about what their products could do, according to whistleblowers.”
However, MIPS and MACRA are only recent updates to the original federal legislation that launched the drive to incentivize hospitals, physicians and other providers to adopt and use EHR systems that met defined criteria. It was the $787-billion stimulus bill—the American Recovery and Reinvestment Act of 2009 (ARRA)—that actually defined the incentive program and allotted an initial $17 billion specifically to encourage adoption of EHR systems.
Now, more than a decade later, there is growing evidence
that many EHR vendors and providers took advantage of the EHR incentives
without meeting both the intent and requirements of this federal program. For
example, government reviewers found that some providers and vendors collected
their federal EHR subsidy payments and then “gamed” the system by programming the
software to appear to meet incentive criteria, even though it had not, Becker’s
Hospital Review reported.
“The only problem (with software certification) is that it presupposed that the [EHR] product [certified by a] vendor would be the same product it sold. It presupposes that people will go into the certification process and participate in good faith,” John Halamka, MD, a Professor of Medicine at Harvard Medical School, Chief Information Officer at Beth Israel Deaconess Medical Center, and Co-Chairman of the national HIT Standards Committee, told KHN.
According to Fortune–KHN study findings:
Lawsuits filed by “dozens” of whistleblowers, doctors, and hospitals allege EHR software used by hospitals and medical offices may “pose danger to patients;”
Some of the $38 billion in federal EHR subsidies went to companies that “deceived the government about the quality of their products;”
Three EHR vendors were part of settlement deals totaling $357 million with the US Department of Justice (DOJ);
28% of doctors and 5% of hospitals who said they met government standards for EHR adoption and use were later found to have not done so, audits showed;
$941 million in inappropriately released EHR subsidies were recovered by federal officials.
Investigation Suggests EHRs Linked to Medical Errors
In one case, a patient had gone to the emergency room with severe headaches and a high fever. During the diagnostic process, a doctor performed a spinal tap to rule out meningitis, an inflammation of the tissue covering the brain and spinal cord. Later, through the hospital’s new EHR system, an infectious disease specialist ordered a clinical laboratory test to check the spinal fluid for viruses, including herpes simplex. Unfortunately, the lab test order did not make it to the lab.
A lawsuit later filed by the patient stated that the hospital’s EHR didn’t “interface” with the hospital medical laboratory, delaying results of the lab test, resulting in brain damage due to herpes encephalitis, Fortune reported. In the lawsuit, the patient alleges the missed order meant he did not receive an antiviral medication (aciclovir) that could have minimized the brain damage.
After interviewing 100 doctors, patients, IT experts, health
policy leaders, attorneys and government officials, Fortune–KHN found:
“Thousands of deaths, serious injuries, and near misses tied to software glitches, user errors, or other flaws;”
EHRs enabled “upcoding” or inflating a bill instead of improving billing;
A “disconnected patchwork” instead of an electronic superhighway.
The researchers found that “The usability of current EHR systems received a grade of F by physician users when evaluated using a standardized metric of technology usability. A strong dose-response relationship between EHR usability and the odds of burnout was observed.”
In their survey of 870 doctors, the researchers asked for a ranking of EHR system usability on a scale of 0 to 100. The mean score of 45.9 was deemed an “F,” Becker’s Hospital Review explained.
The researchers suggested that “Given the association
between EHR usability and physician burnout, improving EHR usability may be an
important approach to help reduce health care professional burnout.”
That could be the understatement of the decade.
“It is a national imperative to overhaul the design and use of EHRs and reframe the technology to focus primarily on its most critical function—helping physicians care for their patients. Significantly enhancing EHR usability is key,” said Patrice Harris, MD, President of the American Medical Association, in a statement.
All is not well with the EHR segment of healthcare
information technology, as attested to by the number of lawsuits, complaints,
and news accounts of patient harm due to misperforming EHR systems and user
error. Because of the growing number of lawsuits involving the function and use
of different EHR products, clinical laboratory leaders would be wise to ensure
their EHR interfaces to healthcare providers function correctly and check them
often.
These initiatives are
a call-to-action for clinical laboratories to contribute their expertise in
support of wellness programs
Two of the largest healthcare systems in America are moving
in non-traditional directions to proactively address certain healthcare
populations. Most recently, Kaiser
Permanente announced it will be investing millions of dollars to tackle
homelessness and the disease outbreaks associated with it. The health system is
even investing in a housing complex in Oakland, Calif., which it hopes will help
patients in that area who face housing insecurity.
Kaiser’s new direction mirrors a similar project by Geisinger Health designed to address the
health of certain populations. In 2017, Geisinger launched what it calls the “Fresh Food Farmacy” for
its adult diabetic and obese patients to give them access to healthy foods. Geisinger
finds this service saves substantial money in downstream medical expenses
because the patients are healthier.
If these programs are harbingers of things to come, clinical
laboratories open to supporting such wellness programs will find
opportunities heading their way.
The housing complex consists of 41-units and is in an area
where existing residents are at risk of displacement due to gentrification.
Kaiser Permanente’s purchase means the complex will be blocked from
redevelopment and will remain affordable for the residents who live there.
“Housing security is a crucial health issue for vulnerable
populations,” Bernard
Tyson, Chairman and CEO at Kaiser Permanente, stated in a news
release. “Access to affordable housing is a key component to Kaiser
Permanente’s mission to improve the health of our members and the communities
we serve.”
This unusual move is part of a larger strategy to invest in
the economic, social, and environmental conditions that impact the health of Kaiser’s
patients. It’s also part of a greater trend toward value-based, proactive
healthcare.
Proactive versus Reactive Care
Healthcare delivery in the US is transitioning from
volume-based to value-based care. The Kaiser and Geisinger projects are championing
another equally critical change—proactive care instead of reactive care. This
shift in priorities promises to change how health systems and healthcare
providers think about healthcare delivery. And clinical pathology laboratories play
a critical role in these changes.
“Specifically, in the transition from volume-based to
value-based healthcare, clinical laboratories are called upon to provide
programmatic leadership in reducing total cost of care through optimization of
time-to-diagnosis and time-to-effective therapeutics, optimization of care
coordination, and programmatic support of wellness care, screening, and
monitoring. This call to action is more than working with industry stakeholders
on the basis of our expertise; it is providing leadership in creating the
programs that accomplish these objectives,” James M. Crawford,
MD, PhD, and co-authors, noted in their paper, “Improving American
Healthcare Through Clinical Lab 2.0: Santa Fe Report,” published in the journal
Academic
Pathology.
Food as a Prescription
Patients encounter all sorts of challenges in addition to
housing. Geisinger Health’s Fresh Food Farmacy program promises to help obese
and diabetic patients who face food insecurity maintain healthy diets. Coupled
with exercise, the program acts like medication in helping regulate blood sugar
and improving long-term outcomes for people with diabetes.
Patients in the program are given a referral, called a
prescription, by their primary care physician. Once enrolled, they receive a
welcome kit that includes food measurement instruments, recipes, and
nutritional information. Each week, they also receive enough food to prepare
healthy, nutritious meals twice a day for five days for their families.
Enrolled patients attend weekly support groups to learn
about self-management. And they complete an online wellness class to help them
learn about nutrition. The program also offers free cooking and nutrition
classes taught by dieticians and health coaches.
Proactive, Value-Based Care and Population Health
“With what’s happening in this nation right now, there’s
never been a more important time for us to focus in on this population and to
do that through a united front,” Lloyd Dean, CEO at CommonSpirit Health (formerly known as
Dignity Health), told Forbes.
The housing program at Kaiser Permanente and the Fresh Food
Farmacy at Geisinger are just two of the latest examples that healthcare
providers are increasingly focusing on population health. The fee-for-service model
of healthcare pays health systems, hospitals, and other providers, based on the
number of sick they treat. These new programs, however, move the entire
healthcare system toward keeping people from getting sick in the first place.
“I think there’s no doubt that we need to emphasize both
health needs and social service needs, and we should be thinking about these
collectively and not in silos,” Signe
Peterson Flieger, PhD, Assistant Professor of Public Health and Community
Medicine at Tufts University, told Forbes.
As progressive health networks such as Kaiser Permanente and
Geisinger move the traditional sites and types of medical care into new
settings and new directions, medical laboratory managers and personnel need to
stay alert for opportunities to support innovative, new health and wellness
programs in their communities.
US hospitals typically spend $2,424/day to provide inpatient care, according to the KFF report
How much does the average hospital spend/day to provide inpatient care? The numbers vary widely, but the latest statistics from Kaiser Family Foundation (KFF) State Health Facts show West Coast states incur the highest daily operating and non-operating inpatient costs.
This disparity in spending is unlikely to surprise medical laboratory executives working in hospital settings. They know firsthand that operating costs can vary from state-to-state and by hospital ownership type.
Oregon, California, and Washington are the most expensive
three states overall for inpatient hospital care. However, the leaderboard
changes when looking specifically at inpatient care at for-profit hospitals.
In the for-profit hospital category:
North Dakota, South Dakota, and Alaska rack up
the highest expenses/day.
Idaho, California, and Oregon top the non-profit
hospital segment.
Overall in the US, the average hospital incurs expenses of
$2,424/inpatient day, the KFF reports.
AMA Annual Survey
Rankings
Rankings are based on information from the 1999-2017 American Hospital
Association Annual Survey, which includes all operating and non-operating
expenses for registered US community hospitals. The figures are an estimate of
the expenses incurred by a hospital to provide a day of inpatient care. They
have been adjusted higher to reflect an estimate of the volume of outpatient
services, according to the KFF. The numbers do not reflect actual charges or
reimbursement for the care provided.
Most expensive average expenses/inpatient day:
Oregon, $3,599
California, $3,441
Washington, $3,429
Idaho, $3,119
District of Columbia, $3,053
Least expensive average expenses/inpatient day:
Montana, $1,070
Mississippi, $1,349
South Dakota, $1,505
Wyoming, $1,520
Alabama, $1,554
Most expensive non-profit hospitals/inpatient day:
Idaho, $4,208
California, $3,800
Oregon, $3,546
Washington, $3,500
Colorado, $3,319
Least expensive non-profit hospitals/inpatient day:
Mississippi, $1,365
South Dakota, $1,519
Iowa, $1,564
Montana, $1,627
Alabama, $1,723
Most expensive for-profit hospitals/inpatient day:
North Dakota, $4,701
South Dakota, $3,956
Alaska, $3,280
Nebraska, $3,031
Wisconsin, $2,830
Least expensive for-profit hospitals/inpatient day:
Maine, $1,055
Maryland, $1,207
West Virginia, $1,362
Iowa, $1,558
Arkansas, $1,619
Most expensive state/local government hospitals/inpatient
day:
Oregon, $4,062
Connecticut, $3,979
Washington, $3,312
California, $3,217
Utah, $3,038
Least expensive state/local government hospitals/inpatient
day:
Montana, $52
South Dakota, $442
Pennsylvania, $787
Nebraska, $906
Georgia, $917
Some Regions Pay Much
More for Healthcare
The KFF report did not look at whether patients in states
where hospitals incur the highest daily operating and non-operating expenses
also pay the most for hospital services. Hospital charges vary widely, with
many treatments costing far more in some regions than others.
In addition, health bills can vary at different hospitals in
the same city or region. According to Healthcare.gov,
the average total cost of a three-day hospital stay is about $30,000.
Adding to the confusion is the fact that hospital costs,
billed charges, and the amounts paid by patients for services can be distinctly
different amounts. Health insurance companies, for example, negotiate lower
rates with hospitals and health systems for their plan enrollees. While patients
without insurance are billed full price for services based on the hospital’s chargemaster.
CMS Final Rule
Requires Pricing Transparency
As of Jan. 1, 2019, a new Centers for Medicare and Medicaid Services (CMS) rule went into effect aimed at making hospital pricing more transparent. The CMS is now requiring hospitals to publish chargemaster price lists online, rather than release those numbers to patients upon request.
However, healthcare advocates have questioned the rule’s
impact on transparency. Posted hospital pricing information is often hard to
access and difficult to comprehend. In addition, chargemaster prices typically
do not represent the actual costs passed on to consumers.
“[The chargemaster] is the list price. When you go to buy a car, you have a manufacturer’s suggested retail price. This is basically what [the chargemaster] is,” Medical Contributor Natalie Azar, MD, told NBC News.
“Prevention comes first,” Nechrebecki suggests. “Utilize the
ambulatory care clinics. Go see your doctors and do what they recommend to keep
yourself healthy. Eat well and exercise often. You will prevent many surgeries
and hospitalizations.”
Sound advice. Nevertheless, clinical laboratories and anatomic pathology groups should take note of the federal government’s ongoing push for price transparency and prepare accordingly.
Some experts in medical community question value of health screenings of older patients with shortened life expectancies, though many aging adults are skeptical of calls to skip tests
What does it mean when a credible health organization makes the assertion that there is an “epidemic” of clinical laboratory testing being ordered on the nation’s elderly? Clinical laboratory leaders and anatomic pathologists know that lab tests are a critical part of screening patients.
Health screenings, particularly those for chronic diseases, such as cancer, can save lives by detecting diseases in their early stages. However, as consumers become more engaged with the quality of their care, one trend is for healthcare policymakers to point out that many medical procedures and care protocols may not bring benefit—and may, instead, bring harm.
No less an authority than Kaiser Health News (KHN) also is questioning what it calls an “epidemic” of testing in geriatric patients. Since medical laboratory tests are part of many screening programs, a rethinking of what tests are necessary in older patients would likely impact clinical laboratories and pathology groups going forward.
Treatment Overkill or Necessary Clinical Laboratory Tests?
That opinion is supported by a 2014 study published in the Journal of the American Medical Association (JAMA) Internal Medicine. The researchers concluded, “A substantial proportion of the US population with limited life expectancy received prostate, breast, cervical, and colorectal cancer screening that is unlikely to provide net benefit. These results raise concerns about over screening in these individuals, which not only increases healthcare expenditure but can lead to patient harm.”
Yet, seniors and their family members often request health screenings for themselves or their elderly parents, even those with dementia, if they perceive doing so will improve their quality of life, KHN noted.
Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at Yale University, told Kaiser Health News patients “well into their 80s, with other health conditions” are unlikely candidates for the many routine health screening tests administered to elderly patients. Were this to become a trend, medical laboratories could see a drop in physician-ordered screening tests. (Photo copyright: Yale University.)
Meanwhile, an earlier study in JAMA Internal Medicine found older adults perceived screening tests as “morally obligatory” and were skeptical of stopping routine screenings.
In its series, KHN noted two studies that outlined the frequency of screening tests in seniors with limited life expectancies due to dementia or other diseases:
According to the American Journal of Public Health, nearly one in five women with severe cognitive impairment are still getting regular mammograms;
Likewise, 55% of older men with a high risk of death over the next decade still receive PSA tests for prostate cancer, the 2014 JAMA Internal Medicine study found.
“Screening tests are often done in elderly patients as a knee-jerk reaction,” Damon Raskin, MD, a board-certified internist in Pacific Palisades, Calif., who also serves as Medical Director for two skilled nursing facilities, told AgingCare.com.
Correct Age or Correct Test?
While a movement may be afoot to reduce screening tests in older patients, a one-size-fits-all answer to who should continue to be tested may not be possible.
“You can have an 80-year-old who’s really like a 60-year-old in terms of [his or her] health,” Raskin noted. “In these instances, screening tests such as mammograms and colonoscopies, can be extremely valuable. However, I’ve seen 55-year-olds who have end-stage Parkinson’s or Alzheimer’s disease. For those individuals, I probably wouldn’t recommend screenings, for quality of life reasons.”
However, for the general population, researchers have emphasized that the focus should not be on whether physicians are ordering “unnecessary” lab tests, but whether they are ordering the “correct” tests.
A 2013 study published in the online journal PLOS ONE analyzed 1.6 million results from 46 of medicine’s 50 most commonly ordered lab tests. Researchers found, on average, the number of unnecessary tests ordered (30%) was offset by an equal number of necessary tests that went unordered.
“It’s not ordering more tests or fewer tests that we should be aiming for. It’s ordering the right tests, however few or many that is,” senior author Ramy Arnaout, MD, Harvard Medical School, Assistant Professor of Pathology and Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center in Boston, stated in a news release. “Remember, lab tests are inexpensive. Ordering one more test or one less test isn’t going to ‘bend the curve,’ even if we do it across the board. It’s everything that happens next—the downstream visits, the surgeries, the hospital stays—that matters to patients and to the economy and should matter to us.”
Since the elderly are the fastest growing population in America, and since diagnosing and treating chronic diseases is a multi-billion-dollar industry, it seems unlikely that such a trend to move away from medical laboratory health screenings for the very old will gain much traction. Still, with increasing focus on healthcare costs, the federal government may pressure doctors to do just that.
Should this milestone be an indicator that more patients are willing to use telehealth to interact with providers, then clinical laboratories and pathology groups will need to respond with new ways to collect specimens and report results
Telehealth is gaining momentum at Kaiser Permanente (KP). Public statements by Kaiser administrators indicate that the number of virtual visits (AKA, telemedicine) with providers now is about equal to face-to-face visits with providers. This trend has many implications for clinical laboratories, both in how patient samples are collected from patients using virtual provider visits and how the medical laboratory test results are reported.
That this is happening at KP is not a surprise. The health system is well-known as a successful healthcare innovator. So, when its Chairman and Chief Executive Officer Bernard Tyson publically announced that the organization’s annual number of virtual visits with healthcare providers had surpassed the number of conventional in-person appointments, he got the members’ attention, as well as, the focus of former US Senator Bill Frist, MD, who moderated the event.
Tyson made this statement during a gathering of the Nashville Health Care Council. He informed the attendees that KP members have more than 100 million encounters each year with physicians, and that 52% of those are virtual visits, according to an article in Modern Healthcare.
However, when asked to comment about Tyson’s announcement during a video interview with MedCity News following the 13th Annual World Health Care Congress in Washington, DC, Robert Pearl, MD, Executive Director/CEO of the Permanente Medical Group and President/CEO of the Mid-Atlantic Permanente Medical Group (MAPMG), stated, “Currently we’re doing 13-million virtual visits—that’s a combination of secure e-mail, digital, telephone, and video—and we did 16-million personal visits. But, by 2018, we expect those lines will cross because the virtual visits [are] going up double digits, whereas the in-person visits are relatively flat.”
So, there’s a bit of disagreement on the current numbers. Nevertheless, the announcement that consumer demand for virtual visits was increasing sparked excitement among the meeting attendees and telemedicine evangelists.
“It’s astounding,” declared Senator Frist, “because it represents what we all want to do, which is innovate and push ahead,” noted an article in The Tennessean.
Is this a wake-up call for the healthcare industry? Should clinical laboratories start making plans for virtual patients?
Of virtual office visits, Pearl noted in the interview with MedCity News, “Why wouldn’t you want, if the medical conditions are appropriate, to have your care delivered from the convenience of your home, or wherever you might be, at no cost to you, and to have it done immediately without any delays in care?”
Pearl added that one-third of patients in primary care provider virtual visits are able to connect with specialists during those sessions.
“It’s better quality, greater convenience, and certainly better outcomes as care begins immediately,” he noted.
Kaiser Permanente ‘Reimagines’ Medical Care
The virtual visit milestone is an impactful one at Kaiser Permanente, an Oakland, Calif.-based nonprofit healthcare organization that includes Kaiser Foundation hospitals, Permanente Medical Groups, and the Kaiser Foundation Health Plan. It suggests that the KP has successfully integrated health information technology (HIT) with clinical workflows. And that the growing trend in virtual encounters indicates patients are becoming comfortable accessing physicians and clinicians in this manner.
As Tyson stated during the Nashville meeting, it is about “reimagining medical care.”
Bernard Tyson (right), Chairman and CEO of Kaiser Permanente, speaking with former Senator Bill Frist, MD (left), at the Nashville Health Care Council meeting where he announced that the non-profit provider’s number of virtual visits with patients had surpassed its face-to-face appointments. (Photo Credit: Nashville Health Care Council.)
What does “reimagining” mean to the bottom line? He shared these numbers with the audience, according to the Modern Healthcare report:
25% of the system’s $3.8 billion in capital spending goes to IT;
7-million people are Kaiser Permanente members;
95% of members have a capitated plan, which means they pay Kaiser Permanente a monthly fee for healthcare services, including the virtual visits.
The American Telemedicine Association, which itself interchanges the words “telemedicine” and “telehealth,” noted that large healthcare systems are “reinventing healthcare” by using telemedicine. The worldwide telemedicine market is about $19 billion and expected to grow to more than $48 billion by 2021, noted a report published by Research and Markets.
Consumers Want Virtual Health, but Providers Lag Behind Demand
Most Americans are intrigued with telehealth services. However, not everyone is participating in them. That’s according to an Advisory Board Company Survey that found 77% of 5,000 respondents were interested in seeing a doctor virtually and 19% have already done so.
Healthcare systems such as Kaiser Permanente and Cleveland Clinic are embracing telehealth, which Dark Daily covered in a previous e-briefing. However, the healthcare industry overall has a long way to go “to meet consumer interest in virtual care,” noted an Advisory Board news release about the survey.
“Direct-to-consumer virtual specialty and chronic care are largely untapped frontiers,” noted Emily Zuehlke, a consultant with The Advisory Board Company (NASDAQ:ABCO). “As consumers increasingly shop for convenient affordable healthcare—and as payers’ interest in low-cost access continues to grow—this survey suggests that consumers are likely to reward those who offer virtual visits for specialty and chronic care,” she stated.
Telehealth Could Increase Healthcare Costs
Does telehealth reduce healthcare spending? A study published in Health Affairs suggests that might not be the case. The researchers found that telemedicine could actually increase costs, since it drives more people to use healthcare.
“A key attraction of this type of telehealth for health plans and employers is the potential savings involved in replacing physician office and emergency department visits with less expensive virtual visits. However, increased convenience may tap into unmet demand for healthcare, and new utilization may increase overall healthcare spending,” the study authors wrote in the Health Affairs article.
Clinical Laboratories Can Support Virtual Healthcare
Clinical laboratories must juggle supporting consumer demand for convenience, while also ensuring health quality expectations and requirements. How can pathologists and medical laboratory leaders integrate their labs with the patient’s virtual healthcare experience, while also aiming for better and more efficient care? One way would be to explore innovative ways to contact patients about the need to collect specimens subsequent to virtual visits. Of course, the procedures themselves must be done in-person. Nevertheless, medical laboratories could find ways to digitally complement—through communications, test results sharing, and education—patients’ use of virtual visits.