This is important for clinical laboratory leaders to watch, because medical labs often interface with hospital EHRs to exchange vital patient data, a key component of complying with Medicare’s EHR incentive programs. If claims of interoperability are shown to be false, could labs engaged with those hospital systems under scrutiny be drawn into the DOJ’s investigations?
Violating the False Claims Act
In May, Coffey Health System (CHS), which includes Coffey County Hospital, a 25-bed critical access hospital located in Burlington, Kan., agreed to pay the US government a total of $250,000 to settle a claim that it violated the False Claims Act.
CHS’ former CIO filed the qui tam (aka, whistleblower) lawsuit, which allows individuals to sue on behalf of the government and share in monetary recovery. He alleged that CHS provided false information to the government about being in compliance with security standards to receive incentive payments under the EHR Incentive Program.
According to a DOJ press release, “the United States alleged that Coffey Health System falsely attested that it conducted and/or reviewed security risk analyses in accordance with requirements under a federal incentive program for the reporting periods of 2012 and 2013. The government contended that the hospital submitted false claims to the Medicare and Medicaid Programs pursuant the Electronic Health Records (EHR) Incentive Program.”
“Medicare and Medicaid beneficiaries expect that providers ensure the accuracy and security of their electronic health records,” said Stephen McAllister (above), United States Attorney for the District of Kansas, in the DOJ press release. “This office remains committed to protecting the federal health programs and to hold accountable those whose conduct results in improper payments.” (Photo copyright: US Department of Justice.)
The Recovery Act allocated $25 billion to incentivize healthcare professionals and facilities to adopt and demonstrate meaningful use (MU) of electronic health records by January 1, 2014. The federal Centers for Medicare and Medicaid Services (CMS) released the incentive funds when providers attested to accomplishing specific goals set by the program.
The website of the Office of the National Coordinator for Health Information Technology (ONC), HealthIt.gov, defines “meaningful use” as the use of digital medical and health records to:
Improve quality, safety, efficiency, and reduce
health disparities;
Engage patients and their families;
Improve care coordination and population and
public health; and
Maintain privacy and security of patient health
information.
The purpose of the HITECH Act was to address privacy and security concerns linked to electronic storage and transference of protected health information (PHI). HITECH encourages healthcare organizations to update their health records and record systems, and it offers financial incentives to institutions that are in compliance with the requirements of the program.
When eligible professionals or eligible hospitals attest to being in compliance with Medicare’s EHR incentive program requirements, they can file claims for federal funds, which are paid and audited by the Department of Health and Human Services (HHS) through Medicare and Medicaid.
Institutions receiving funds must demonstrate meaningful use
of EHR records or risk potential penalties, including the delay or cancellation
of future payments and full reimbursement of payments already received. In
addition, false statements submitted in filed documents are subject to criminal
laws and civil penalties at both the state and federal levels.
EHR Developers Under Scrutiny by DOJ
EHR vendors also have been investigated and ordered to make
restitutions by the DOJ.
In February, Greenway Health, a Tampa-based EHR developer, agree to pay $57.25 million to resolve allegations related to the False Claims Act. In this case, the government contended that Greenway obtained certification for its “Prime Suite” EHR even though the technology did not meet the requirements for meaningful use.
And EHR vendor eClinicalWorks paid the government $155 million to settle allegations under the False Claims Act. The government maintained that eClinicalWorks misrepresented the capabilities of their software and provided $392,000 in kickbacks to customers who promoted its product.
Legal cases such as these demonstrate that the DOJ will
pursue both vendors and healthcare organizations that misrepresent their
products or falsely attest to interoperability under the terms laid out by
Medicare’s EHR Incentive Program.
Clinical laboratory leaders and pathology groups should carefully
study these cases. This knowledge may be helpful when they are asked to create
and maintain interfaces to exchange patient data with client EHRs.
Despite the widespread adoption of electronic health record (EHR) systems and billions in government incentives, lack of interoperability still blocks potential benefits of digital health records, causing frustration among physicians, medical labs, and patients
Clinical laboratories and anatomic pathology groups understand the complexity of today’s electronic health record (EHR) systems. The ability to easily and securely transmit pathology test results and other diagnostic information among multiple providers was the entire point of shifting the nation’s healthcare industry from paper-based to digital health records. However, despite recent advances, true interoperability between disparate health networks remains elusive.
One major reason for the current situation is that multi-hospital health systems and health networks still use EHR systems from different vendors. This fact is well-known to the nation’s medical laboratories because they must spend money and resources to maintain electronic lab test ordering and resulting interfaces with all of these different EHRs.
Healthcare IT News highlighted the scale of this problem in recent coverage. Citing data from the Healthcare Information and Management Systems Society (HIMSS) Logic database, they note that—when taking into account affiliated providers—the typical health network engages with as many as 18 different electronic medical record (EMR) vendors. Similarly, hospitals may be engaging with as many as 16 different EMR vendors.
The graphics above illustrates why interoperability is the most important hurdle facing healthcare today. Although the shift to digital is well underway, medical laboratories, physicians, and patients still struggle to communicate data between providers and access it in a universal or centralized manner. (Images copyright: Healthcare IT News.)
The lack of interoperability forces healthcare and diagnostics facilities to develop workarounds for locating, transmitting, receiving, and analyzing data. This simply compounds the problem.
Pressure from Technology Giants Fuels Push for Interoperability
According to HITECH Answers, the Centers for Medicare and Medicaid Services (CMS) has paid out more than $38-billion in EHR Incentive Program payments since April 2018.
Experts, however, point out that government incentives are only one part of the pressure vendors are seeing to improve interoperability.
“There needs to be a regulatory push here to play referee and determine what standards will be necessary,” Blain Newton, Executive Vice President, HIMSS Analytics, told Healthcare IT News. “But the [EHR] vendors are going to have to do it because of consumer demand, as things like Apple Health Records gain traction.”
Another solution, according to TechTarget, involves developing application programming interfaces (APIs) that allow tech companies and EHR vendors to achieve better interoperability by linking information in a structured manner, facilitating secure data transmission, and powering the next generation of apps that will bring interoperability ever closer to a reality.
TechTarget reported on how University of Utah Hospital’s five hospital/12 community clinic health network, and Intermountain Healthcare, also in Utah, successfully used APIs to develop customized interfaces and apps to improve accessibility and interoperability with their Epic and Cerner EHR systems.
Diagnostic Opportunities for Clinical Laboratories
As consumers gain increased access to their data and healthcare providers harness the current generation of third-party tools to streamline EHR use, vendors will continue to feel pressure to make interoperability a native feature of their EHR systems and reduce the need to rely on HIT teams for customization.
For pathology groups, medical laboratories, and other diagnosticians who interact with EHR systems daily, the impact of interoperability is clear. With the help of tech companies, and a shift in focus from government incentives programs, improved interoperability might soon offer innovative new uses for PHI in diagnosing and treating disease, while further improving the efficiency of clinical laboratories that face tightening budgets, reduced reimbursements, and greater competition.
While approaches differ between the three companies, heavy investment in EMR/EHR and other HIT solutions could signal significant changes ahead for a market currently dominated by only a few major developers
If healthcare big data is truly a disruptive force in healthcare’s transformation, then a big battle looms for control of that data. Some experts say that the companies now dominating the electronic health record (EHR) market will soon face tough competition from the world’s biggest tech companies.
How this will impact medical laboratories and pathology practices remains to be seen. Labs are sure to be influenced by coming events, since clinical laboratory test data represents the largest proportion of an individual patient’s permanent medical record. It’s important to note, though, that while most EHR/HIT developers have been motivated by federal incentives, Google (NASDAQ:GOOG), Apple (NASDAQ:AAPL), and Microsoft (NASDAQ:MSFT) are motivated by consumer demand, which increasingly dictates the direction of health technology development.
Thus, they may be better positioned to compete moving forward, as patients, physicians, and hospitals turn to precision medicine and value-based care for improved outcomes and increased revenues.
“The EMR efforts have moved hospitals from paper to digital records,” Bruce Carlson (above), Publisher of Kalorama Information, told HIT Infrastructure. “The next step is for tech giants to glean the data and improve upon that infrastructure. We’ll be talking about EHR in different ways in the next ten years.” (Photo copyright: Twitter.)
EMR/EHR Market Poised for Disruption
According EHR Intelligence, as of 2017, 97% of all US non-federal acute care hospitals and 84% of US hospitals had adopted an EHR system. Of these hospitals, more than half (50.5%) use products from just two developers—Cerner or Epic. That’s according to Health Data Management’s coverage of the KLAS report “US Hospital EMR Market Share 2017.”
However, recent interest in HIT and EHR systems by major Silicon Valley tech companies could lead to potential disruptions in the current state of the market. According to The New York Times, in the first 11 months of 2017, 10 of the largest US technology companies were involved in healthcare equity deals worth $2.7-billion. This marks a drastic increase over the 2012 figure of $277-million.
Though each company is approaching the market differently, Google, Microsoft, and Apple are all working on projects that could influence how both consumers and healthcare professionals interact with and utilize medical record data.
Of the three, Apple is the most consumer-centric with their Apple Health personal health record (PHR) integration into Apple iOS for iPhones and iPads. Microsoft, however, is working on developing analytics tools and storage solutions aimed at healthcare providers in general. And Google, through its parent company Alphabet, is focusing on data processing and storage.
Amazon also is working on its own HIT project which it calls 1492. While details are scant, HIT Infrastructure reports that the project is focused on interoperability among disparate EHR systems to improve sharing of protected health information (PHI) between providers, patients, and other healthcare providers, such as clinical labs and pathology groups. HIT Infrastructure also reported on rumors of Amazon branching into telemedicine using their Amazon Echo and Alexa platforms.
Security Concerns and Opportunities for Clinical Laboratories
According to Computerworld’s coverage of IDC research, by 2020, 25% of patients are expected to be taking part in ‘bring your own data” healthcare scenarios. Tech-savvy medical laboratories could find opportunities to interact directly with patients and encourage follow-through on test orders or follow-up on routine testing.
However, shifting protected health information to devices carried by consumers is not without risks.
“How do I know the data won’t make its way to some cloud somewhere to be shared, sold, etc.” Jack Gold, Principal Analyst with J. Gold Associates, told Computerworld. “And if I rely on an app to tell me what to do—say, take my meds—and it somehow gets hacked, can it make me sick, or worse?”
Nevertheless, with tech giants already developing products for the consumer market and healthcare provider industry, it’s a given consumers will soon gain greater access to their own healthcare information. Whether patients will ultimately embrace it, how they will use it, and how developers will interact with the data, is still undefined. But it’s coming and clinical laboratories should be prepared.
While Apple recently debuted features to bring personal health records and protected health information to its mobile devices, Microsoft shuttered HealthVault in favor of focusing on AI-powered healthcare advances
As clinical laboratories and anatomic pathology groups know, lab testing data comprise more than 70% of the average patient’s health record. Thus, creating a universal platform on which consumers can share or review health information and medical histories with caregivers is a critical, yet elusive goal for most major tech companies, including tech giants Apple (Nasdaq:AAPL) and Microsoft (Nasdaq:MSFT).
Apple has big plans for patient health records and is working to bring protected health information (PHI) and healthcare advice to iPhones, iPads, and Apple Watch. Meanwhile, Microsoft is reducing its footprint in the mobile device healthcare market. Instead, it appears to be banking on its Artificial Intelligence (AI) platform. How these two diverging paths play out could have ramifications for the pathology and clinical laboratory industries.
HealthVault Insights versus AI versus Apple Health Mobile Apps
Launched in February 2017, Microsoft’s HealthVault Insights combined machine learning and AI with patients’ PHI and mobile activity tracking. The intent was to create an accessible, interactive platform for patients to monitor important health trends.
However, as of January 2018, Microsoft pulled the mobile app from Android, iOS, and Windows App stores. While summary information that draws on previously collected data is still available from the HealthVault website, new data and detailed insights are no longer available.
“We launched HealthVault Insights as a research project … with the goal of helping patients generate new insights about their health,” states Microsoft’s HealthVault Insights website. “Since then, we’ve learned a lot about how machine learning can be used to increase patient engagement and are now applying that knowledge to other projects.”
Shuttering HealthVault highlighted Microsoft’s shift away from consumer-facing health efforts and toward assisting medical laboratories, physicians, and research groups discover and implement treatments driving modern personalized medicine.
In a Microsoft blog post, Peter Lee, Corporate VP of Microsoft Healthcare, stated that Microsoft hopes its Healthcare NeXT platform will “dramatically transform healthcare, will deeply integrate Greenfield research and health technology product development, as well as establish a new model at Microsoft for strategic health industry partnerships.”
HealthVault Insights was one of several projects in Microsoft’s Healthcare NeXT initiative. Run by Microsoft’s AI and Research Group and partnering with major healthcare and research facilities across the country, other projects in the Healthcare NeXT initiative include:
Speaking with Business Insider, Lee noted that healthcare is becoming a “very large business” for Microsoft. “We don’t talk publicly about the dollars, but it’s large,” he concluded.
Microsoft’s EmpowerMD website states the eventual goal is to use the system to connect conversations with the growing trove of healthcare data available. “Our long-term vision is a learning system that incorporates data from longitudinal medical records, medical devices, genomics, population health, research papers, and more.”
AI a ‘Sleeping Giant for Healthcare’
“AI can be viewed as a sleeping giant for healthcare,” Eric Horvitz, PhD, Director of Microsoft Research Labs, told Nasdaq, when discussing Microsoft’s view of technology and healthcare. “AI methods show promise for multiple roles in healthcare. [This includes] inferring and alerting about hidden risks of potential adverse outcomes, selectively guiding attention, care, and interventional programs where [they are] most needed and reducing errors in hospitals.”
One such project involves a strategic partnership with the University of Pittsburg Medical Center (UPMC), which is a “$13-billion Pittsburgh-based system, comprising more than 25 hospitals, a three-million-member health plan, and 3,600 physicians, [that] will be a core partner in our efforts to improve healthcare delivery through a series of projects, beginning with a focus on transforming clinician empowerment and productivity,” according to Microsoft.
“Despite UPMC’s efforts to stay on the leading edge of technology, too often our clinicians and patients feel as though they’re serving the technology rather than the other way around. With Microsoft, we have a shared vision of empowering clinicians by reducing the burden of electronic paperwork and allowing the doctor to focus on the sacred doctor-patient relationship,” Steven D. Shapiro, MD (above), Chief Medical and Scientific Officer of UPMC and President of UPMC’s Health Services division, stated in the Microsoft blog. [Photo copyright: University of Pittsburg Medical Center.]
Today, patients can directly interact with their PHI to analyze trends and take a proactive role in their own healthcare, while researchers tap into the computational power of Cloud computing and correlate data across vast sources using AI. Both trends highlight how technology continues to play a critical role in improving access to healthcare. And how tech researchers continue to develop more efficient and effective treatments.
Medical laboratories and anatomic pathology groups may soon contribute health information to databases that one day will power AI systems. These trends highlight opportunities to both educate physicians on the tools available to utilize patient health data in an effective manner, and on new platforms that clinical laboratories could use to further streamline operations, reduce costs, and boost efficiency.
Industry analysts speculate that Apple might be planning to enter the EHR and healthcare related markets by transforming mobile technologies into gateway devices connected to providers’ EHR systems and patient data
Imagine a mobile device that monitors vitals while connected in real-time to healthcare providers, electronic health records (EHR), and clinical laboratories. One that measures the physical condition and emotional state of the user by casting light onto skin, and then records and transmits it with a swipe of the touch screen. Would such an innovation change how patients expect to interact with their providers? And how physicians, anatomic pathologists, and medical laboratories receive data from their patients? Certainly.
How this would affect medical laboratories and anatomic pathology groups remains to be seen. But where Apple goes, industries follow. Thus, it’s worth following the company’s activities in the healthcare market.
Bringing Clinical Data, Medical Laboratory Test Results, to iPhone
Mobile devices launched the era of consumer-grade fitness wearables. It’s not uncommon for a smart phone or watch to capture and store a range of health data generated by users. This can include everything from heart rate and sleeping patterns to dietary logs and fertility tracking. But, to date, much of that healthcare data is user generated and does not integrate in any meaningful way with the majority of EHR systems. Nor does it enable communications with primary care providers or diagnostic services—such as medical laboratories or pathology groups.
This may soon change.
According to a CNBC report, a unit at Apple is “in talks with developers, hospitals, and other industry groups about bringing clinical data—such as detailed lab results and allergy lists—to the iPhone, according to a half-dozen people familiar with the team.”
The report states that Apple:
· “Wants the iPhone to become the central bank for health information;
· “Is looking to host clinical information, such as labs and allergy lists, and not just wellness data; and,
· “Is talking with hospitals, researching potential acquisitions, and attending health IT industry meetings.”
Christina Farr, the report’s author, predicts that Apple could be preparing to apply its music industry model to the healthcare industry by, “Replacing CDs and scattered MP3s with a centralized management system in iTunes and the iPod—in the similarly fragmented and complicated landscape for health data.”
At a special event in September, Apple COO Jeff Williams (above) announced Stanford Medicine’s Apple Heart Study, which uses “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation,” and, according to Williams, “notify users.” This is just one of several healthcare-related study collaborations Apple is exploring. It is not known if Apple is looking to collaborate with medical laboratories. (Photo copyright: Apple.)
Apple’s History with Healthcare Related Technology
Taken as a single event, these speculations might not convince industry leaders. However, Apple’s long-term investments and acquisitions show a clear trend toward integrating healthcare data into the Apple ecosystem.
· Unveiled three different APIs—HealthKit, ResearchKit, and CareKit—designed to help capture, analyze, communicate, and integrate healthcare data with the Apple iOS and watchOS ecosystems;
· Engaged with the Argonaut Project and Health Gorilla (a centralized hub of healthcare data and information) suggesting a shift from wearables and basic device-based biometrics toward in-depth reporting, interoperability, and access to third-party healthcare data repositories—such as those in a person’s EHR or medical laboratory portal.
The Future of EHRs or Another Failed Attempt at Innovation?
Apple isn’t the only company to attempt such a system. Other efforts include Microsoft’s Health Vault and Google’s now shuttered Google Health. Another CNBC article notes that Amazon is also researching healthcare related options. “The new team is currently looking at opportunities that involve pushing and pulling data from legacy electronic medical record systems,” stated Farr. “The group is also exploring health applications for existing Amazon hardware, including Echo and Dash Wand.”
However, where most services fail to gain traction is user engagement. After all, if a system isn’t widely used or fails to offer benefits over existing systems, patients and service providers are not likely to go through the process of switching systems. Speaking with CNBC, Micky Tripathi, President and CEO of the Massachusetts eHealth Collaborative notes, “At any given time, only about 10% to 15% of patients care about this stuff. If any company can figure out engagement, it’s Apple.”
According to comScore, 85.8-million people over the age of 13 already own an iPhone in the US. The upcoming facial recognition features on Apple’s iPhone X might also provide the added security needed for those questioning the safety of their data. Should Apple succeed, communicating data between clinical laboratories, physicians, and patients might be both convenient and fast. More importantly, it might be the universal platform that finally provides health data access across the entire care continuum, while simultaneously improving access to providers and empowering healthcare consumers.
Of course, this is a few years from reality. But, we can speculate … would innovative medical laboratories have their patients’ lab test data hosted in the Cloud in such a way that patients and providers could access it securely, along with other protected clinical records?
Imagine how this would enable patients to have their complete medical record traveling with them at all times.
