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eClinicalWorks Will Pay $155M to Settle False Claims Act Allegations

May 31, 2017
by Heather Landi
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In addition to the monetary settlement, the vendor must give customers updated versions of their software free of charge and allow customers to transfer their data to another EHR software provider, without service charges

Electronic health records (EHR) software vendor eClinicalWorks, and some of its employees, will pay $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 U.S. Department of Justice.

In a statement about the civil investigation settlement, eClinicalWorks stated that it would, in addition to paying $155 million, bolster its compliance program related to the development, operation and maintenance of its software.

“eCW fully cooperated with the DOJ civil investigation, which centered on technical certification requirements of the Federal government’s ‘Meaningful Use’ EHR program, and the company denies any wrongdoing. The claims settled by the agreement are allegations only and there has been no determination of liability,” the company stated.

The American Recovery and Reinvestment Act of 2009 established the Electronic Health Records (EHR) Incentive Program to encourage healthcare providers to adopt and demonstrate their “meaningful use” of EHR technology. Under the program, the U.S. Department of Health and Human Services (HHS) offers incentive payments to healthcare providers that adopt certified EHR technology and meet certain requirements relating to their use of the technology. To obtain certification for their product, companies that develop and market EHR software must attest that their product satisfies applicable HHS-adopted criteria and pass testing by an accredited independent certifying entity approved by HHS.

In its complaint-in-intervention, the federal government alleges that the Westborough, Mass.-based EHR vendor “falsely obtained that certification for its EHR software when it concealed from its certifying entity that its software did not comply with the requirements for certification.”

The Justice Department alleges in its compliant that, as a result of the deficiencies in eClinicalWorks’ software, providers using eClinicalWorks’ software submitted false claims for federal incentive payments.

Under the terms of the settlement agreements, ECW and three of its founders (Chief Executive Officer Girish Navani, Chief Medical Officer Rajesh Dharampuriya, M.D., and Chief Operating Officer Mahesh Navani) are jointly and severally liable for the payment of $154.92 million to the United States. Separately, Developer Jagan Vaithilingam will pay $50,000, and Project Managers Bryan Sequeira, and Robert Lynes will each pay $15,000.

eClinicalWorks said it disputed the DOJ's allegations, yet decided to settle to avoid the cost and uncertainty inherent in protracted litigation. “eCW has consistently maintained that it conducted testing of its software prior to release to ensure that it met applicable Meaningful Use program requirements, and that any certification issues were addressed in accordance with the administrative process established by the government. eCW’s software remains certified for use in connection with the Meaningful Use program,” the company said in a statement.

The company also said that, as is common in the industry, it previously had a customer referral program. “While eCW does not believe its customer referral program was unlawful, it has discontinued the program,” the company said.

“Today’s settlement recognizes that we have addressed the issues raised, and have taken significant measures to promote compliance and transparency,” Girish Navani, CEO and co-founder of eClinicalWorks, said in a prepared statement. “We are pleased to put this matter behind us and concentrate all of our efforts on our customers and continued innovations to enhance patient care delivery.”

Essentially, the Justice Department accused the vendor of "gaming" the certification test. In a press release, the Justice Department wrote, "For example, in order to pass certification testing without meeting the certification criteria for standardized drug codes, the company modified 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."

In addition, the Justice Department alleges that ECW’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from ECW’s software to the software of other vendors.

Special Agent in Charge Phillip Coyne of HHS-OIG said in a prepared statement, “Electronic health records have the potential to improve the care provided to Medicare and Medicaid beneficiaries, but only if the information is accurate and accessible. Those who engage in fraud that undermines the goals of EHR or puts patients at risk can expect a thorough investigation and strong remedial measures such as those in the novel and innovative Corporate Integrity Agreement in this case.”

According to the Justice Department press release, the settlement also 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, which permit private individuals to sue on behalf of the government for false claims and to share in any recovery. As part of today’s resolution, Mr. Delaney will receive approximately $30 million.

“This settlement is the largest False Claims Act recovery in the District of Vermont and we believe the largest financial recovery in the history of the State of Vermont,” Acting U.S. Attorney Eugenia A.P. Cowles for the District of Vermont, said in a prepared statement. “This significant recovery is a testament to the hard work and dedication of this office and our partners in the Commercial Litigation Branch of the Civil Division and at HHS. This resolution demonstrates that EHR companies will not succeed in flouting the certification requirements.”

As part of the settlement, ECW entered into a Corporate Integrity Agreement (CIA) with the HHS Office of Inspector General (HHS-OIG) covering the company’s EHR software. The five-year CIA requires, among other things, that ECW retain an Independent Software Quality Oversight Organization to assess ECW’s software quality control systems and provide written semi-annual reports to OIG and ECW documenting its reviews and recommendations, according to the Justice Department press release.

Further, the agreement also requires eClinicalWorks to allow customers to obtain updated versions of their software free of charge and to give customers the option to transfer their data to another EHR software provider, without penalties or service charges. The vendor must also retain an Independent Review Organization to review its arrangements with healthcare providers to ensure compliance with the Anti-Kickback Statute.

This matter was jointly handled by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the District of Vermont, the HHS Office of Inspector General, and multiple HHS agencies and components.

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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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HHS Issues Comprehensive Draft Report with Eyes on Reducing Health IT Burden

November 28, 2018
by Rajiv Leventhal, Managing Editor
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Required by the Cures Act, the strategy lays out core issues and challenges related to health IT burden, while offering several recommendations

The Department of Health and Human Services (HHS) has issued a federal draft strategy designed to help reduce administrative and regulatory burden on clinicians caused by technology such as electronic health records (EHRs).

The draft strategy, which is 74 pages, was developed by the health IT arm of the federal government—the Office of the National Coordinator for Health Information Technology (ONC)—in partnership with the Centers for Medicare & Medicaid Services (CMS), and was required in the 21st Century Cures Act.

According to federal health IT officials, “The draft strategy reflects the input and feedback received by ONC and CMS from stakeholders, including clinicians, expressing concerns that EHR burden negatively affects the end user and ultimately the care delivery experience. This draft strategy includes recommendations that will allow physicians and other clinicians to provide effective care to their patients with a renewed sense of satisfaction for them and their patients.”

Based on the input received by ONC and CMS, the draft strategy outlines three overarching goals designed to reduce clinician burden:

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Regional Health knew providing leading EHR technology was not the only factor to be considered when looking to achieve successful adoption, clinician and patient satisfaction, and ultimately value...

1. Reduce the effort and time required to record health information in EHRs for clinicians;

2. Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and

3. Improve the functionality and intuitiveness (ease of use) of EHRs.

Officials noted in the announcement today that healthcare stakeholders have indicated to ONC and CMS that when they use their EHRs, clinicians have to rely on checkboxes, templates, cut-and-paste functions, and other workarounds that hinder the intended benefits of EHRs. Clinicians have reported they are spending more time entering data into the EHR, leaving less time to interact with their patients. Required documentation guidelines have led to “note bloat,” making it harder to find relevant patient information and effectively coordinate a patient’s care.

According to ONC officials in a blog post accompanying the draft strategy today, “By releasing this draft strategy, we are taking one more step toward improving the interoperability and usability of health information by establishing a goal, strategy, and recommendations to reduce regulatory and administrative burdens relating to the use of EHRs.” But, they added, “We can’t do this alone. The Cures Act, and a thorough analysis of the drivers of burden, require that the government and industry work together to reduce the burden of using EHRs.”

Throughout the last few years, ONC and CMS have undoubtedly made burden reduction a top priority in their respective agencies. ONC even created a position in 2017— deputy assistant secretary for health technology reform—that would specifically focus on burden reduction, tapping John Fleming, M.D., a former Congressman and a practicing family physician to fill the role.

Meanwhile, CMS, in the last several months, has overhauled the  Medicare and  Medicaid Promoting  Interoperability  Program  (formerly known as the EHR Incentive Programs) and has proposed to overhaul the Merit-based Incentive Payment System (MIPS) Promoting Interoperability performance category (formerly known as the Advancing Care Information performance category) to focus on interoperability, improve flexibility, and relieve burden.

In notable comments today from Donald Rucker, M.D., National Coordinator for Health IT, he said, “We look forward to advancing the premise of how to accurately model and support the clinical cognitive process in the EHR—a shift away from a strictly linear, logic-based model to a more sophisticated design that supports the complex pattern recognition inherent in the diagnostic and treatment process.”

Rucker added more details in his comments: “New healthcare-specific software design elements will help produce software tailored to the clinical workflow. We envision a time when clinicians will use the medical record not as an encounter-based document to support billing, but rather as a tool to fulfill its original intention: supporting the best possible care for the patient….Similarly, quality  reporting should be seamless, accessible  through  the metadata  in  the  EHR, and  available  through high-quality,  clinically mature application programming interfaces (APIs), which will reduce the need to separately submit data.”

The Cures Act, signed into law in December 2016, requires HHS to articulate a plan of action to reduce regulatory and administrative burden relating to the use of health IT and EHRs. Specifically, the Cures Act directs HHS to: establish a goal for burden reduction relating to the use of EHRs; develop a strategy for meeting that goal; and develop recommendations to meet the goal.

For this draft report, HHS reviewed stakeholder input and established four workgroups which included representatives from across HHS, including ONC, CMS, and other federal offices.  Each of these workgroups focused on a different aspect of EHR-related burden, specifically: clinical documentation; health IT usability and the user experience; EHR reporting; and public health reporting.

For each of these aspects, the report lays out what the core issues and challenges are, while then outlining an array of strategies and recommendations for improvement.

In a statement, HHS Secretary Alex Azar said, “Usable, interoperable health IT was one of the first elements of the vision I laid out earlier this year for transforming our health system into one that pays for value. With the significant growth in EHRs comes frustration caused, in many cases, by regulatory and administrative requirements stacked on top of one another. Addressing the challenge of health IT burden and making EHRs useful for patients and providers, as the solutions in this draft report aim to do, will help pave the way for value-based transformation.”

Added Seema Verma, CMS Administrator, “Over the past year, we hosted listening sessions, received written feedback, and heard from a wide range of clinical stakeholders about the current health IT systems and the requirements specifying documentation, reimbursement, and quality reporting that are burdensome and should be re-examined.” 

The public comment period on the draft strategy is open until January 28, 2019.


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