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Ground-breaking whistleblower case against EHR vendor eClinicalWorks settles for $155M

Whistleblower lawsuit against eClinicalWorks settles for $155 million in ground-breaking case against an electronic health records vendor

BURLINGTON, VERMONT, May 31, 2017 – A whistleblower represented by Phillips & Cohen LLP provided key information to the government that led to eClinicalWorks (eCW) settlement of civil fraud and kickback charges today for $155 million.

“This is a ground-breaking case,” said Colette G. Matzzie, a whistleblower attorney and partner at Phillips & Cohen. “It is the first time that the government has held an electronic health records vendor accountable for failing to meet federal standards designed to ensure patient safety and quality patient care.”

The settlement is a “first” in two other ways: (1) An electronic health records (EHR) vendor is being held accountable for the truthfulness and accuracy of representations made when seeking government certification of its electronic health records system; and (2) The government applied the federal Anti-Kickback Statute (AKS) law to the promotion and sale of EHR systems.

The government’s settlement agreement holds eCW and eCW’s founders and executives Girish Navani, Dr. Rajesh Dharampuriya, and Mahesh Navani liable for payment.  The government today also announced it has reached separate settlements with three eClinicalWorks employees who will pay a total of $80,000 to the government to settle civil allegations.

The whistleblower, Brendan Delaney, was a New York City government employee implementing 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.

The government’s complaint joining the “qui tam” (whistleblower) lawsuit alleged that eClinicalWorks:

·         Falsely certified that its EHR met all government criteria

·         Failed to adequately test software before it was released

·         Failed to correct critical and urgent problems and bugs in the software “for months and even years.”

·         Failed to ensure data portability and audit log requirements

·         Failed to reliably record laboratory and diagnostic imaging orders

·         Paid kickbacks totaling at least $392,000 to influential customers to recommend eClinicalWorks products to prospective customers as well as other kickbacks in the form of “consulting” and “speaker” fees

“Accurate and reliable electronic health records are essential to good patient care and safety,” said Matzzie. “The most important outcome of the case is that multiple steps have been taken to alert eClinicalWorks customers, so patients now are better protected.”

eClinicalWorks is the provider of one of the most popular electronic health records software. The privately held company, based in Westborough, MA, says on its website that over 70,000 medical facilities, 115,000 providers and 800,000 medical professionals use its EHR technology.

Both the government and the whistleblower alleged that eClinicalWorks falsely represented to customers that its EHR system complied with federal requirements known as “Meaningful Use” rules.

“Compliance with federal requirements is essential for EHR sales,” said Larry Zoglin, a whistleblower attorney who is Of Counsel to Phillips & Cohen. “Doctors and other healthcare providers can receive federal incentive payments for purchasing EHR technology only if the government certifies that the EHR product they buy meets government standards.”

The incentive program, created by Congress in 2009 to promote the use of EHR, provided payments of up to $43,720 over five years from Medicare to individual healthcare practitioners up until last year. Medicaid incentive payments to individual practitioners can total up to $63,750 over six years until 2021.

Problems that were caused by eClinicalWorks EHR, as alleged in the whistleblower complaint, include:

·         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

·         Inaccurate tracking of laboratory results

·         Software security problems that undermined the integrity of the medical record

During the government’s investigation of Delaney’s allegations, eClinicalWorks sent out in 2016 a series of advisories to customers, educating them on potential patient safety risks related to use of its EHR.  For instance, a December 2016 notice from eClinicalWorks highlighted a number of risks related to medication management, drug-allergy interactions and updating progress notes with use of its software.  (A list of eCW’s advisories is posted on the Phillips & Cohen website.)

“Brendan Delaney provided the government with information about eClinicalWorks software that became central aspects of the government’s case,” attorney Zoglin said. “He worked tirelessly to document and track the EHR problems, often working until late at night, after a full day at his job. He felt a responsibility to the community at large to get the problems fixed.”

Delaney has worked as a consultant on EHR systems for various hospitals and healthcare providers since he left employment with the City of New York in 2011.

“I was profoundly saddened and disappointed by the indifference of senior health department officials and investigators for New York City when I provided detailed information about serious flaws in the EHR software that could endanger patients,” Delaney said. “I am grateful that Phillips & Cohen and federal government attorneys recognized the seriousness of my charges and dug into the matter quickly and thoroughly.”

The case has been “under seal” – meaning it wasn’t publicly known – since Phillips & Cohen filed the qui tam lawsuit on behalf of Delaney in 2015 in federal district court in Burlington, Vermont.

“The government attorneys and investigators who worked on this case were single-minded in their efforts to protect patients and recover funds for taxpayers,” Matzzie said. “I want to commend the US Department of Justice, the US Attorney’s Office for the District of Vermont and the US Department of Health and Human Services.  Assistant US Attorney Owen Foster’s perseverance and efforts, in particular, were a big reason this case was successful.”

“Brendan Delaney, Phillips & Cohen and the government team collaborated very closely and effectively to build this case and bring it to a successful conclusion,” Matzzie noted.

Former US Attorney Tristram J. Coffin and Eric Poehlmann of Downs Rachlin Martin PLLC served as local counsel in the case.

For more information about the allegations and the settlement, see:

·         The whistleblower’s complaint against eClinicalWorks [US ex rel. Delaney v. eClinicalWorks, LLC, Case No. 15-CV-00095 (D. Vt.)]

·         The government’s complaint in intervention, filed May 12, 2017

·         The settlement agreement with eClinicalWorks

·         The Department of Justice Press release

·         US Attorney’s Office for the District of Vermont press release

About Phillips & Cohen LLP

Phillips & Cohen is the nation’s most successful law firm representing whistleblowers, with recoveries for governments totaling more than $12.1 billion in civil settlements and criminal fines. The firm represents whistleblowers in qui tam lawsuits as well as cases brought under the whistleblower reward programs of the Securities and Exchange Commission, the Commodity Futures Trading Commission and the Internal Revenue Service. www.phillipsandcohen.com

May 31, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

athenahealth, eClinicalWorks, Epic, NextGen Healthcare and Surescripts First to Adopt Enhanced Data Sharing Practices

Five Healthcare IT Leaders Adopt Carequality Interoperability Framework

McLEAN, VA. (January 21, 2016) – Carequality, an initiative of The Sequoia Project, today announced initial implementers of the Carequality Interoperability Framework released in December 2015.  The companies are athenahealth®, eClinicalWorks, Epic, NextGen Healthcare and Surescripts.

The five organizations have agreed to provide health information exchange services for their customers under the comprehensive Framework, which consists of legal terms, policy requirements, technical specifications, and governance processes. The Framework is an operationalization of the groundbreaking Principles of Trust to enable nationwide health information exchange.

“The adoption of the Carequality Framework represents a major leap forward for nationwide interoperability,” explained Dave Cassel, director of Carequality. “By these organizations committing to unified Rules of the Road, they are simplifying system-to-system connections to make data exchange easier for a significant portion of the healthcare ecosystem.”

The initial implementers of the Carequality Interoperability Framework – and their clients – will benefit from accelerated, less costly health data sharing agreements, because they no longer need to develop one-off legal agreements between individual data sharing partners. These health information exchange partnerships are able to leverage existing networks and business relationships to rapidly expand.  For example, most physicians already have access to a small network through a technology vendor or a health information exchange (HIE). These existing health data sharing opportunities will dramatically expand to include additional providers, payers, government agencies, and others as the Carequality community grows.

The initial implementers will focus first on query-based exchange of clinical documents, but the Framework was developed to support an unlimited variety of use cases.

Quotes from adopting organizations:

“athenahealth believes that physicians should be allowed to focus on patients, not the hassles of coordinating care,” said Doran Robinson, Vice President of Network Integration for athenahealth.  “We’re thrilled to join other major players in reducing the legal and regulatory barriers that impede the development of a national health information backbone that connects care settings, regardless of vendor or service provider.”

“eClinicalWorks is the largest cloud EHR in the nation and we are dedicated to improving the delivery of healthcare,” explained Girish Navani, CEO and co-founder of eClinicalWorks. “We continue to promote interoperability and enhance the patient experience. The Carequality Interoperability Framework is an exciting initiative to aid our customers in sharing pertinent health data and providing better care.”

“The Carequality Framework is a testament to healthcare vendors’ commitment toward making seamless interoperability a reality for patients and providers,” says Dave Fuhrmann, Vice President of Interoperability for Epic. “Shared rules and guidelines are going to make it possible for all of us to dramatically increase the number of connections we have across systems to make care safer and more efficient.”

“Securely sharing health data across health networks creates the kind of informed and empowered care system required for a successful transition to value-based medicine,” said Rusty Frantz, president and chief executive officer of Quality Systems Inc. “As industry leaders we’re making true progress in nationwide data exchange and look forward to using the Carequality framework to make the right information easily accessible, to the right care team, the right clinician, at the right time and place.”

“Through the Carequality Framework, Surescripts is breaking down legacy barriers and collaborating with other industry leaders to make nationwide healthcare interoperability a reality,” said Tom Skelton, CEO of Surescripts. “We are excited to increase the reach of our network and unleash the power of our National Record Locator Service to enable nationwide data sharing to improve patient care.”

About Carequality
Carequality is a public-private collaborative that facilitates agreement among diverse stakeholders to develop and maintain a common interoperability framework enabling exchange between and among data sharing networks. Carequality brings together a diverse group of representatives from the private sector and government to come to collective agreement on how to enable data to flow seamlessly between and among networks and providers, much like the telecommunications industry did for linking cell phone networks.  For more information, visitwww.carequality.org and follow us at twitter.com/carequalityNet.

About The Sequoia Project
The Sequoia Project is a non-profit 501c3 chartered to advance implementation of secure, interoperable nationwide health information exchange. The Sequoia Project supports multiple, independent health IT interoperability initiatives, most notably: the eHealth Exchange, a rapidly growing community of exchange partners who share information under a common trust framework and a common set of rules; and Carequality, a public-private collaborative effort to build consensus among existing data sharing networks regarding technical specifications and best practices, much like the telecommunications industry did for linking cell phone networks. For more information about The Sequoia Project and its initiatives, visitwww.sequoiaproject.org. Follow The Sequoia Project on Twitter: @SequoiaProject.

January 22, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

HIMSS Analytics Announces eClinicalWorks as Certified Educator of the EMR Adoption Model

CHICAGO (January 14, 2015) – HIMSS Analytics named eClinicalWorks a Certified Educator of its EMR Adoption Modelsm (EMRAM).

EMRAM is an eight-step process that allows healthcare provider organizations to analyze their level of EMR adoption, chart accomplishments, and benchmark progress against other healthcare organizations across the country. Each of the stages is measured by cumulative capabilities and all capabilities within each stage must be reached before progressing.

“We’re happy to be able to confirm eClinicalWorks as an EMRAM Certified Educator,” said Blain Newton, COO, HIMSS Analytics. “EMRAM allows organizations to align IT initiatives and overall business strategy, which is essential to shaping future direction and moving the industry forward.”

Vendors achieving HIMSS Analytics Certified Educator status must pass an annual certification exam and commit to an annual educator program. This ensures they stay current with trends within the model and are equipped with the necessary knowledge to help their clients advance through the various stages.

“A major goal is having our customers utilizing the EMR the most beneficial way possible for both providers and patients,” said Girish Navani, CEO and co-founder of eClinicalWorks. “This certification will benefit organizations looking to analyze their adoption of EMR technology. We welcome being part of the program.”

For more information on the EMR Adoption Model, visit www.himssanalytics.org/emram.

About HIMSS Analytics
HIMSS Analytics collects, analyzes and distributes essential health IT data related to products, costs, metrics, trends and purchase decisions.  It delivers quality data and analytical expertise to healthcare delivery organizations, IT companies, governmental entities, financial, pharmaceutical and consulting companies. Visi twww.himssanalytics.org.

About eClinicalWorks
eClinicalWorks is a privately-held company focused on ambulatory clinical solutions. Its technology extends the use of electronic health records beyond practice walls and creates community-wide records. The company is second largest in the country for e-prescribing. Based in Westborough, Mass., eClinicalWorks has additional offices in New York City, Chicago, California and Georgia. For more information, please visitwww.eclinicalworks.com, Facebook, Twitter or call 866-888-6929.

January 14, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.