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What are the Potential Ripple Effects of the eClinicalWorks Settlement?

June 14, 2017
by Heather Landi
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This is Part One of 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 recent settlement of a False Claims Act lawsuit against electronic health records software vendor eClinicalWorks should serve as a wake-up call to both health IT vendors, and the healthcare providers who are the end-users of these technologies, according to many healthcare IT industry leaders.

On May 31, 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.

The complaint alleges eClinicalWorks falsely attested to its certifying body that it met certification requirements under the Meaningful Use program, and in turn caused its healthcare provider customers to make false claims for incentive payments under the Meaningful Use program. The U.S. Department of Health and Human Services (HHS) established the Meaningful Use program, pursuant to the HITECH Act, and it provides incentive payments to healthcare providers who demonstrate meaningful use of certified EHR technology.

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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Regarding the allegations that its customer referral program violated the federal Anti-Kickback statute, Navani wrote in the letter, “While referral programs like this are common in the industry, and while HHS-OIG (Department of Health and Human Services Office of the Inspector General) has provided no guidance regarding them, the government took the position that the payments were improper. We disagreed but have nevertheless discontinued the program.”

Jeffrey Smith, vice president of public policy at the Washington, D.C.-based American Medical Informatics Association (AMIA), says, on the surface, the settlement is about the federal government holding an electronic health records vendor accountable for allegedly failing to meet federal standards designed to ensure patient safety and quality patient care. “When you peel back the layers of the onion a little bit, what you find is that this case sheds light on genuine deficiencies in the current health IT certification program, and it details the many ways that risks to patient safety can arise when software is not developed properly or when it’s not implemented or used properly,” he says.

“This case really highlights how benign glitches can have far-reaching impacts to patient safety. I imagine every single CIO out there understands this notion very well, because while we all suffer through computer glitches and little hiccups on smartphones—in healthcare, a glitch can be the difference between life and death,” Smith says. “I think if you are a CIO trying to figure out what is that you want to do as a result of this, you should probably go and have a conversation with your vendor to make sure that they understand the implications of this $155 million settlement. And, I anticipate that the $155 million that the government is getting is only the beginning.”

Drilling Down into the Case

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 qui tam, or whistleblower, provisions of the False Claims Act, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery. As a result of the resolution, Delaney will receive approximately $30 million.

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

In its complaint-in-intervention, the Justice Department accused the vendor of "gaming" the certification test, by, for example, modifying its software by “hardcoding” only the drug codes required for testing. “In other words, rather than programming the capability to retrieve any drug code from a complete database, ECW simply typed the 16 codes necessary for certification testing directly into its software. ECW’s software also did not accurately record user actions in an audit log and in certain situations did not reliably record diagnostic imaging orders or perform drug interaction checks,” the Justice Department stated in a press release about the settlement.

eClinicalWorks’ Navani responded to these allegations in the letter to the company’s customers. He wrote, “One of the technical non-conformities alleged by the government involved the use of RxNorm codes in electronic prescriptions. From 2014 to August 2016, electronic prescriptions sent by eClinicalWorks users included NDC codes rather than RxNorm codes. During this time period, more than 500 million prescriptions were successfully transmitted and filled, and most major pharmacies did not support RxNorm codes. The failure to include RxNorm codes in electronic prescriptions was completely inadvertent on the part of eClinicalWorks, as our software used RxNorm codes in other parts of the system, such as in C-CDAs. We gained nothing by not including the codes, which are available for free from the National Library of Medicine. We resolved this issue as soon as we learned of it.”

Navani also wrote that, historically, technical non-conformities with the MU Program were addressed through an administrative rather than a legal process, and specifically pointed to ONC's Certified Health IT Product List website for a list of EHR vendors with non-conformities. “eClinicalWorks chose to settle this matter to avoid the uncertainty of a prolonged legal dispute which could have been disruptive to our customers, our employees and our company,” he stated.

Considering the implications of the fraud allegations, Bob Ramsey, an attorney who focuses on healthcare as a shareholder/partner at the Pittsburgh, Pa.-based law firm Buchanan, Ingersoll & Rooney, says the case should serve as a wake-up call to health IT vendors about the importance of being compliant with certification requirements. “It really underscores that all parties, vendors, suppliers, or anyone that is touching the healthcare system, needs to be careful. Are other vendors doing the same kind of thing? I don’t think so, but I don’t know so, and if they are, they better be careful, a $155 million settlement should get their attention,” he says. Ramsey added that the Justice Department was clearly sending a message by holding the company’s founding officers and executives liable as well. “The government is doing that on purpose, sending a message to the industry to say, ‘It’s not just corporate accountability here, it’s individuals, and we will go after individuals.’”

Health IT vendors should review their systems and their procedures for identifying and correcting software design and quality issues that call into question EHR software’s conformity to applicable EHR certification criteria or that could pose patient safety or clinician usability risks, many health IT leaders say. “Compliance programs and compliance officers are absolutely critical,” Ramsey says. “Healthcare providers have had compliance programs for years, and the EHR vendors probably should adopt a similar approach.”

As part of the settlement, eClinicalWorks also agreed to a five-year Corporate Integrity Agreement (CIA) with strict reporting obligations and compliance oversight. “For five years, this company is going to be closely scrutinized by the government. And those corporate integrity agreements are very carefully drafted by the government and are very difficult to comply with; it means really dotting the i’s and crossing the t’s. It’s an important message from the government to the industry which is, ‘EHRs can have an impact on patient safety and patient health and on outcomes and we’re not going to tolerate fraud, because people’s lives are potentially at risk here.’”

Farzad Mostashari, M.D., former National Coordinator for Health IT, and now CEO of health IT company Aledade, shared his thoughts on Twitter the day the news broke: “Let me be plain-spoken. eClinicalWorks is not the only EHR vendor who flouted certification/misled customers. Other vendors better clean up.

AMIA’s Smith also is not as optimistic as Ramsey that the allegations against eClinicalWorks represent a “one-off” case. “One of the things that has come to light is that the certification program itself is highly reliant on the honor system,” he says, “I think we will learn more over the coming weeks and months about just how pervasive this kind of activity may well be. I would like to think that eClinicalWorks is the only organization out there that has gamed the certification program the way that they did, but I doubt it. I find it hard to believe that eClinicalWorks would be the only such developer that used the honor system to their benefit, at least early on.”

Is More Federal Oversight Needed?

There are many safety advocates who contend that the current oversight structure isn’t strong enough. The allegations raised in the lawsuit against eClinicalWorks, and the idea that EHR vendors could, potentially, “game” the certification tests poses a genuine concern for the health IT community, Smith says. “That’s a real question that needs to be asked, ‘How do we stop it from happening?’”

Ramsey anticipates that the HHS will review the certification process. “This may be evidence that the certification program did have some faults in it. I think the government may start scrutinizing the certifiers.”

Smith says, “I do think there are potential avenues to mitigate these kinds of actions and potentially the enhanced oversight rule that ONC finalized late last year would be one avenue through which we could identify these issues earlier on when they are happening, as opposed to several years after the fact, which was the case here.”

Last October, ONC issued a final rule that updates the ONC Health IT Certification Program and sets up a regulatory framework for ONC to directly review certified health IT products and take necessary action in circumstances involving potential risks to public health and safety.  The “Enhanced Oversight and Accountability” final rule focuses on three key areas—direct review, enhanced oversight and greater transparency and accountability.

In a written comment, Mostashari said, “This settlement proves that, for interoperability and safety, the country needs ONC to be accountable for the integrity of EHR certification. This is a clear case for why Congress should, at the least, maintain ONC’s funding to meet this accountability and protect patients.” Mostashari’s comment about funding relates to the Trump Administration’s proposed 2018 budget, which includes cutting $22 million from ONC’s budget.

However, some in the health IT industry have voiced concerns about increasing ONC’s regulatory oversight, saying it could slow innovation and adversely affect patient safety by impeding access to health IT products. When ONC announced its Enhanced Oversight and Accountability final rule in October, Health IT Now Coalition executive director Robert Horne issued a statement stating that ONC “is clearly overstepping its statutory authority by moving forward with direct review of uncertified functionalities and products, in addition to certified products.”

"Our chief concern is the potential for negative consequences from the ONC final rule. Simply put, the Office of the National Coordinator for Health IT was not created by Congress to be a regulator like the Food and Drug Administration (FDA),” Horne said in his statement.

Beyond federal oversight, EHR vendors will likely be under increased scrutiny from end-users, who will feel emboldened to speak up about problems with EHR software.

The second part of this article, which will post online Friday, will focus on how the eClinicalWorks lawsuit settlement sheds light on interoperability issues and the potential impact on the EHR vendor market.

 


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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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