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Does the eClinicalWorks Settlement Shine a Light on Patient Safety, Interoperability Issues?

June 16, 2017
by Heather Landi
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This is the second story in a two-part article that examines the potential impact of the eClinicalWorks settlement on health IT policy and the vendor market
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The first part of this two-part article was published on Wednesday and can be read here.

Some health IT leaders view the recent settlement of a False Claims Act lawsuit against electronic health records software vendor eClinicalWorks as shining a spotlight on the need for a stronger focus on health IT-related patient safety, and on the lack of interoperability within the industry. What are the potential policy implications of the eClinicalWorks settlement? And, what could be the ripple effects in the EHR vendor market?

Last month, the U.S. Department of Justice announced a settlement that holds eClinicalWorks, and the company’s founders and executives—Chief Executive Officer Girish Navani, Chief Medical Officer Rajesh Dharampuriya, M.D., and Chief Operating Officer Mahesh Navani—liable for payment of $155 million to resolve a False Claims Act lawsuit. The company allegedly violated federal law by misrepresenting the capabilities of its software and for allegedly paying kickbacks to certain customers in exchange for promoting its product, according to the Justice Department. Separately, an eClinicalWorks developer and two project managers were also found liable and will pay separate fines.

It is important to note that the Westborough, Mass.-based EHR vendor has not admitted any fault or wrongdoing and its software remains fully certified under the Meaningful Use program.

In response to a media request for an interview about the settlement, an eClinicalWorks spokesperson sent a letter that was sent to the company’s customers. In that letter, eClinicalWorks stated that it would, in addition to paying $155 million, bolster its compliance program. “The inquiry leading to the settlement primarily centered on technical aspects of the Meaningful Use program and allegations that eClinicalWorks software had technical non-conformities related to some of the criteria, all of which have since been addressed,” eClinicalWorks’ CEO Girish Navani stated in the letter.

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As noted in the previous story, the Justice Department’s settlement with eClinicalWorks resolves allegations in a lawsuit filed in the District of Vermont by Brendan Delaney, a software technician formerly employed by the New York City Division of Health Care Access and Improvement. The lawsuit was filed under the whistleblower provisions of the False Claims Act.

Delaney was, at the time, a New York City government employee implementing the eClinicalWorks EHR system at Riker’s Island for prisoner healthcare when he first became aware of numerous software problems that he alleged put patients at risk, according to a press release issued by a law firm, Phillips & Cohen, representing Delaney.

According to the allegations in the whistleblower complaint, problems that were caused by eClinicalWorks EHR software included failure to keep an accurate record of current medications administered to patients, mistakenly including in a patient’s medical record information from another patient’s record, multiple errors with medication module, including failure to ensure proper dosages, errors with start/stop dates, failure to record changes to medications, duplicate orders for certain prescription drugs, and failure to display current medication at all in some instances and inaccurate tracking of laboratory results.

Many health IT industry leaders believe the eClinicalWorks case once again highlights the need for a federal patient safety center focused on health IT-related issues, a project proposed by the Office of the National Coordinator for Health Information Technology (ONC). In fact, two years ago, a task force of experts and health IT safety stakeholders convened by ONC crafted a roadmap to guide the development of a proposed national Health IT Safety Center, however, the initiative has not yet received federal funding.

Jeffrey Smith, vice president of public policy at the Washington, D.C.-based American Medical Informatics Association (AMIA), says, “This is something that AMIA has been advocating for a number of years, along with others, but we have yet to conjure the political will and the money to support a national health IT safety center.” He adds that the case puts a spotlight on the patient safety issues that arise at the intersection of health IT and healthcare. “It gets to the notion of shared responsibility; you can have a perfect system in the lab and it can do wonderfully in a testing scenario, but when you send it out to the real world and hook it up to other systems in a complex IT environment, there is no telling how many things can go wrong. I’m hopeful that as we learn more [about the eClinicalWorks case] it will encourage honest conversation around the need for a national health IT safety center.”

The False Claims Act case against eClinicalWorks also highlights problems in health IT that center on interoperability. The Justice Department, in its case against eClinicalWorks, contends that the vendor’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from eClinicalWorks’ software to the software of other vendors.

In the eClinicalWorks letter sent to customers, Navani also addressed this issue. He wrote, “Another technical non-conformity identified by the government involved data portability. The 2014 Edition certification criteria require EHR software to "batch export" patient records. There was confusion about the meaning of this requirement, however, prompting ONC in 2015 to issue a clarifying FAQ. When eClinicalWorks was tested for certification in 2013, its authorized certification body (ACB) at the time, CCHIT, determined that our software satisfied this requirement. In 2015, our new ACB, Drummond Group, disagreed and identified this as a non-conformity. eClinicalWorks resolved the non-conformity in 2015, and our software meets all MU Stage 2 data portability requirements.”

Later in the letter, Navani wrote, “There is a silver lining to this settlement. Today, eClinicalWorks has a more robust compliance program.”

Many health IT stakeholders contend that the issue of data portability goes beyond compliance, or non-compliance, with health IT certification requirements. The ability to share patient data among clinical IT tools, and the technical and financial obstacles to interoperability, are critical issues among healthcare providers. “The inability of providers to get their data out of one system and into another system, this notion of vendor lock-in, is fundamentally problematic,” Smith says. “And this is where the focus needs to turn in terms of policy and functionality.”

Smith continues, “I don’t know how eClinicalWorks performs on data portability compared to other vendors, but, even if the vendors are simply meeting the letter of the law, what that means is that when a physician wants to switch vendors, then the best outcome that physician can have is that their vendor gives them summary of care records for all their patients, and that is not equal to all of the data on their patients. The technical side of it is daunting, but I have to say, from a patent safety perspective, we should demand nothing less.”

He adds, “I think that’s another area that policymakers should be focusing on because I feel that is an important use case, which is that we need all the data; we essentially need a digital print-all that allows physicians to get all of the patients’ data from one system to another, not just a summary of care record. And, I would be surprised, quite frankly, if every certified system was able to even produce summary of care records on a consistent basis.”

Bob Ramsey, an attorney who focuses on healthcare as a shareholder/partner at the Pittsburgh, Pa.-based law firm Buchanan, Ingersoll & Rooney, says the allegations against eClinicalWorks might represent “an extreme case. “Interoperability and data portability is something that is viewed as necessary in the health world, but it’s easier said than done. Everyone is grappling with it.”

Smith acknowledges that are significant technical challenges with interoperability, “but never in the history of health IT, probably in the history of our technological evolution, has the technical challenge been the thing that keeps us from achieving a goal. I think if we live in a market environment that is not going to go above and beyond what the government is going to require, and if the vendors are essentially going to say that all of their time is tied up in meeting government requirements, then maybe we focus on data portability, a complete digital print-all button, maybe that’s where the focus of government requirements needs to move.”

Other health IT leaders see a silver lining to this case. Aneesh Chopra, who served as the first U.S. Chief Technology Officer and is now president of health IT company NavHealth, responded to news of the eClinicalWorks settlement by tweeting, “Let me sound hopeful. The settlement agreement might catalyze adoption and use of open APIs for patients and providers."

What are the Potential Ripple Effects in the EHR Vendor Market?

As part of the settlement, eClinicalWorks, as noted above, entered into a Corporate Integrity Agreement with the HHS Office of the Inspector General. Stipulations in the agreement require eClinicalWorks to give customers the option to transfer their data to another EHR software provider, without penalties or service charges. Also, eClinicalWorks is obligated to give current customers updated versions of the company’s EHR software free of charge.

How many customers will leave eClinicalWorks and switch to another EHR? “It still up in the air,” notes Erik Bermudez, research director, acute care EMR, ambulatory EMR/PM at Orem, Utah-based KLAS Research. “I could see this going a number of ways—folks could look at this and say I was already satisfied, so absolutely I’m going to stick with eClinicalWorks. But if there are folks already on the fence, and we know from tracking eClinicalWorks for a decade that there’s a percentage of customers already thinking that eClinicalWorks is not part of their long-term plan, then this could potentially speed up the decision for those clients, absolutely.”

He added, “I imagine the customer makeup will be altered in a year from today. It’s going to look a little bit different. Now, how much different? I’m not sure.”

Epic, Cerner and athenahealth are all competitors to eClinicalWorks in the ambulatory space, so time will tell how eClinicalWorks customers will react and if there will be any shifts in competitors’ customer bases.

In response to the news of the eClinicalWorks settlement, athenahealth issued a statement regarding the role of technology to be a partner for providers in navigating ongoing regulatory changes, including Meaningful Use. “Any vendor in the health tech space lives a constant balancing act of innovating, serving clients, and complying with government regulation. It’s a complex job,” Todd Rothenhaus, athenahealth’s chief medical officer, said in the statement. Rothenhaus also noted that athenahealth’s platform and services has enabled the company’s ambulatory clients to achieve an industry leading attestation rate of 97 percent. “We believe that any healthcare provider or organization in the market for an EHR should demand this type of partnership,” Rothenhaus said.

eClinicalWorks started in the physician practice space, and while it has expanded to the small hospital market, the company’s footprint remains in the medical group/ambulatory space, Bermudez says. In KLAS’s 2015-2016 Best in KLAS Awards Software and Services report, eClinicalWorks ranked fifth, with a score of 69.1, in the overall physician practice vendor rankings.

“When we interview an eClinicalWorks client, their EHR is perceived as relatively easy to use, streamlined, has a good look and feel to it and the user interface is pleasant to use. But the challenges for eClinicalWorks, based on what customers report to us, isn’t necessarily from a technology standpoint, it ties back to more of the services and relationship,” Bermudez says.

According to Bermudez, eClinicalWorks customers report that they typically have to pay for software upgrades, so the stipulation in the settlement that the vendor must offer current customers software upgrades, at no charge, is significant news for the current client base. “There are going to be short-term implications, and there will absolutely be long-term implications to this,” he said.


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Allscripts Sells its Netsmart Stake to GI Partners, TA Associates

December 10, 2018
by Rajiv Leventhal, Managing Editor
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Just a few months after Allscripts said it would be selling its majority stake in Netsmart, the health IT company announced today that private equity firm GI Partners, along with TA Associates, will be acquiring the stake held in Netsmart.

In 2016 Allscripts acquired Kansas City-based Netsmart for $950 million in a joint venture with middle-market private equity firm GI Partners, with Allscripts controlling 51 percent of the company. With that deal, Allscripts contributed its homecare business to Netsmart, in exchange for the largest ownership stake in the company which has now become the largest technology company exclusively dedicated to behavioral health, human services and post-acute care, officials have noted.

Now, this transaction represents an additional investment for GI Partners over its initial stake acquired in April 2016, and results in majority ownership of Netsmart by GI Partners.

According to reports, it is expected that this sale transaction will yield Allscripts net after-tax proceeds of approximately $525 million or approximately $3 per fully diluted share.

Founded 50 years ago, Netsmart is a provider of software and technology solutions designed especially for the health and human services and post-acute sectors, enabling mission-critical clinical and business processes including electronic health records (EHRs), population health, billing, analytics and health information exchange, its officials say.

According to the company’s executives, “Since GI Partners' investment in 2016, Netsmart has experienced considerable growth through product innovation and multiple strategic acquisitions. During this time, Netsmart launched myUnity, [a] multi-tenant SaaS platform serving the entire post-acute care continuum, and successfully completed strategic acquisitions in human services and post-acute care technology. Over the same period, Netsmart has added 150,000 users and over 5,000 organizations to its platform.”

On the 2018 Healthcare Informatics 100, a list of the top 100 health IT vendors in the U.S. by revenue, Allscripts ranked 10th with a self-reported health IT revenue of $1.8 billion. Netsmart, meanwhile, ranked 44th with a self-reported revenue of $319 million.

According to reports, Allscripts plans to use the net after-tax proceeds to repay long-term debt, invest in other growing areas of its business, and to opportunistically repurchase its outstanding common stock.

The transaction is expected to be completed this month.

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Study Links Stress from Using EHRs to Physician Burnout

December 7, 2018
by Heather Landi, Associate Editor
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More than a third of primary care physicians reported all three measures of EHR-related stress
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Physician burnout continues to be a significant issue in the healthcare and healthcare IT industries, and at the same time, electronic health records (EHRs) are consistently cited as a top burnout factor for physicians.

A commonly referenced study published in the Annals of Internal Medicine in 2016 found that for every hour physicians provide direct clinical face time to patients, nearly two additional hours are spent on EHR and desk work within the clinic day.

Findings from a new study published this week in the Journal of the American Medical Informatics Association indicates that stress from using EHRs is associated with burnout, particularly for primary care doctors, such as pediatricians, family medicine physicians and general internists.

Common causes of EHR-related stress include too little time for documentation, time spent at home managing records and EHR user interfaces that are not intuitive to the physicians who use them, according to the study, based on responses from 4,200 practicing physicians.

“You don't want your doctor to be burned out or frustrated by the technology that stands between you and them,” Rebekah Gardner, M.D., an associate professor of medicine at Brown University's Warren Alpert Medical School, and lead author of the study, said in a statement. “In this paper, we show that EHR stress is associated with burnout, even after controlling for a lot of different demographic and practice characteristics. Quantitatively, physicians who have identified these stressors are more likely to be burned out than physicians who haven't."

The Rhode Island Department of Health surveys practicing physicians in Rhode Island every two years about how they use health information technology, as part of a legislative mandate to publicly report health care quality data. In 2017, the research team included questions about health information technology-related stress and specifically EHR-related stress.

Of the almost 4,200 practicing physicians in the state, 43 percent responded, and the respondents were representative of the overall population. Almost all of the doctors used EHRs (91 percent) and of these, 70 percent reported at least one measure of EHR-related stress.

Measures included agreeing that EHRs add to the frustration of their day, spending moderate to excessive amounts of time on EHRs while they were at home and reporting insufficient time for documentation while at work.

Many prior studies have looked into the factors that contribute to burnout in health care, Gardner said. Besides health information technology, these factors include chaotic work environments, productivity pressures, lack of autonomy and a misalignment between the doctors' values and the values they perceive the leaders of their organizations hold.

Prior research has shown that patients of burned-out physicians experience more errors and unnecessary tests, said Gardner, who also is a senior medical scientist at Healthcentric Advisors.

In this latest study, researchers found that doctors with insufficient time for documentation while at work had 2.8 times the odds of burnout symptoms compared to doctors without that pressure. The other two measures had roughly twice the odds of burnout symptoms.

The researchers also found that EHR-related stress is dependent on the physician's specialty.

More than a third of primary care physicians reported all three measures of EHR-related stress -- including general internists (39.5 percent), family medicine physicians (37 percent) and pediatricians (33.6 percent). Many dermatologists (36.4 percent) also reported all three measures of EHR-related stress.

On the other hand, less than 10 percent of anesthesiologists, radiologists and hospital medicine specialists reported all three measures of EHR-related stress.

While family medicine physicians (35.7 percent) and dermatologists (34.6 percent) reported the highest levels of burnout, in keeping with their high levels of EHR-related stress, hospital medicine specialists came in third at 30.8 percent. Gardner suspects that other factors, such as a chaotic work environment, contribute to their rates of burnout.

"To me, it's a signal to health care organizations that if they're going to 'fix' burnout, one solution is not going to work for all physicians in their organization," Gardner said. "They need to look at the physicians by specialty and make sure that if they are looking for a technology-related solution, then that's really the problem in their group."

However, for those doctors who do have a lot of EHR-related stress, health care administrators could work to streamline the documentation expectations or adopt policies where work-related email and EHR access is discouraged during vacation, Gardner said.

Making the user interface for EHRs more intuitive could address some stress, Gardner noted; however, when the research team analyzed the results by the three most common EHR systems in the state, none of them were associated with increased burnout.

Earlier research found that using medical scribes was associated with lower rates of burnout, but this study did not confirm that association. In the paper, the study authors suggest that perhaps medical scribes address the burden of documentation, but not other time-consuming EHR tasks such as inbox management.

 

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HHS Studying Modernization of Indian Health Services’ IT Platform

November 29, 2018
by David Raths, Contributing Editor
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Options include updating the Resource and Patient Management System technology stack or acquiring commercial solutions

With so much focus on the modernization of health IT systems at the Veteran’s Administration and Department of Defense, there has been less attention paid to decisions that have to be made about IT systems in the Indian Health Service. But now the HHS Office of the Chief Technology Officer has funded a one-year project to study IHS’ options.

The study will explore options for modernizing IHS’ solutions, either by updating the Resource and Patient Management System (RPMS) technology stack, acquiring commercial off-the-shelf (COTS) solutions, or a combination of the two. One of the people involved in the analysis is Theresa Cullen, M.D., M.S., associate director of global health informatics at the Regenstrief Institute. Perhaps no one has more experience or a better perspective on RPMS than Dr. Cullen, who served as the CIO for Indian Health Service and as the Chief Medical Information Officer for the Veterans Health Administration

During a webinar put on by the Open Source Electronic Health Record Alliance (OSEHERA), Dr. Cullen described the scope of the project. “The goal is to look at the current state of RPMS EHR and other components with an eye to modernization. Can it be modernized to meet the near term and future needs of communities served by IHS? We are engaged with tribally operated and urban sites. Whatever decisions or recommendations are made will include their voice.”

The size and complexity of the IHS highlights the importance of the technology decision. It provides direct and purchased care to American Indian and Alaska Native people (2.2 million lives) from 573 federally recognized tribes in 37 states. Its budget was $5.5 billion for fiscal 2018 appropriations, plus third-party collections of $1.02 billion at IHS sites in fiscal 2017. The IHS also faces considerable cost constraints, Dr. Cullen noted, adding that by comparison that the VA’s population is four times greater but its budget is 15 times greater.

RPMS, created in 1984, is in use at all of IHS’ federally operated facilities, as well as most tribally operated and urban Indian health programs. It has more than 100 components, including clinical, practice management and administrative applications.

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About 20 to 30 percent of RPMS code originates in the VA’s VistA. Many VA applications (Laboratory, Pharmacy) have been extensively modified to meet IHS requirements. But Dr. Cullen mentioned that IHS has developed numerous applications independently of VA to address IHS-specific mission and business needs (child health, public/population health, revenue cycle).

Because the VA announced in 2017 it would sundown VistA and transition to Cerner, the assessment team is working under the assumption that the IHS has only about 10 years to figure out what it will do about the parts of RPMS that still derive from VistA. And RPMS, like VistA, resides in an architecture that is growing outdated.

The committee is setting up a community of practice to allow stakeholders to share technology needs, best practices and ways forward. One question is how to define modernization and how IHS can get there. The idea is to assess the potential for the existing capabilities developed for the needs of Indian country over the past few decades to be brought into a modern technology architecture. The technology assessment limited to RPMS, Dr. Cullen noted. “We are not looking at COTS [commercial off the shelf] products or open source. We are assessing the potential for existing capabilities to be brought into “a modern technology architecture.”

Part of the webinar involved asking attendees for their ideas for what a modernized technology stack for RPMS would look like, what development and transitional challenges could be expected, and any comparable efforts that could inform the work of the technical assessment team.

 

 

 


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