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Saturday, June 3, 2017

Fraud at eClinicalWorks. Are they alone in this regard?

Electronic Health Records Vendor To Pay The Largest Settlement In The District Of Vermont
eClinicalWorks LLC to Pay $155 Million to Resolve Civil False Claims Act Allegations

BURLINGTON, VT – One of the nation’s largest vendors of electronic health records (EHR) software, eClinicalWorks (ECW), and certain of its employees will pay a total of $155 million to resolve a False Claims Act lawsuit alleging that ECW misrepresented the capabilities of its software, the Justice Department announced. The settlement also resolves allegations that ECW paid kickbacks to certain customers in exchange for promoting its product. ECW is headquartered in Westborough, Massachusetts.

“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,” said Acting United States Attorney for the District of Vermont Eugenia A.P. Cowles. “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.”

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 who 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 software satisfies applicable HHS-adopted criteria and pass testing by an accredited, independent, HHS-approved certifying entity.

In its complaint-in-intervention, the government contends that ECW 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. 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, 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. As a result of these and other deficiencies in its software, ECW caused the submission of false claims for federal incentive payments based on the use of ECW’s software.

“Every day, millions of Americans rely on the accuracy of their electronic health records to record and transmit their vital health information,” said Acting Assistant Attorney General for the Civil Division of the Department of Justice Chad A. Readler. “This resolution is a testament to our deep commitment to public health and our determination to hold accountable those whose conduct results in improper payments by the federal government.”

Under the terms of the settlement agreement, 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 $154,920,000 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.

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. This innovative 5-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. ECW must provide prompt notice to its customers of any safety related issues and maintain on its customer portal a comprehensive list of such issues and any steps users should take to mitigate potential patient safety risks. The CIA also requires ECW to allow customers to obtain updated versions of their software free of charge and to give customers the option to have ECW transfer their data to another EHR software provider without penalties or service charges. ECW must also retain an Independent Review Organization to review ECW’s arrangements with health care providers to ensure compliance with the Anti-Kickback Statute.

“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,” said Special Agent in Charge Phillip Coyne of HHS-OIG. “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.”

The settlement with ECW 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. The Act also allows the government to intervene and take over the action, as it did in this case. As part of today’s resolution, Mr. Delaney will receive approximately $30 million.

This matter was jointly handled by Assistant United States Attorneys Owen C.J. Foster and Nikolas P. Kerest of the U.S. Attorney’s Office for the District of Vermont, Kelley Hauser and Edward Crooke of the Commercial Litigation Branch of the Civil Division, the HHS Office of Inspector General, and multiple HHS agencies and components.

The case is captioned United States ex rel. Delaney v. eClinialWorks LLC, 2:15-CV-00095-WKS (D. Vt.). The claims resolved by the settlement are allegations only, and there has been no determination of liability.
Wow. One has to wonder; how many other EHR vendors have been defrauding the ARRA/HITECH program by gaming their ONC Certs?
This irritates me personally. Back when I was in the HealthInsight REC, I served Meaningful Use client practices using 14 different EHR platforms:
Amazing Charts
Allscripts (MyWay and Professional)
Practice Fusion
Optum CareTracker
eClinicalWorks (eCW) alone was at least a 3rd of my book. Back during the prior DOQ-IT era, HealthInsight had sent me to Westborough to train on eCW, so it was the platform with which I was most familiar and adept. Good UX functionality and features (though the workflow paths to some of the MU compliance criteria were "too many clicks" -- albeit hardly unique to eCW).

During the 2014 Health 2.0 Conference, eCW CEO Girish Navani blew a bunch of smoke up my butt, telling me he wanted to sponsor my KHIT blog. Follow-up went nowhere with that. No doubt a good thing, in hindsight.

So, now eCW merely gets Double Secret Probation and a "hefty" fine. But they don't have to admit guilt (LOL, spare me) nor lose their ONC Certification.
"The claims resolved by the settlement are allegations only, and there has been no determination of liability."
Class-action lawsuit comprised of eCW users perhaps in their future? Will CMS attempt to claw back MU incentive funds paid to eCW attestors?

Are other EHR vendors pulling this kind of crap? The "paper charts are better" and anti-ONC, anti-regulatory "free markets uber alles" crowds are all over this CusterFluck.

Jacob Reider at THCB:
Is eClinicalWorks the Next Volkswagen?
From HealthcareIT News:
Concerned the eClinicalWorks fiasco could happen to your EHR? Take these steps now
From FierceHealthcare:
eClinicalWorks settlement hints at broader certification infractions throughout the EHR industry

As Adrian pointed out and with my previous blog post that was referenced, it’s not surprising that events such as this have occurred with this proprietary software with certification boondoggle. Other industries have recognized the immense value of open source and it’s all around us (just not with much fanfare). When will physicians recognize there is much in common to what we do in our profession and the intrinsic ethos of open source software (which does exactly that Dr Zwerling had suggested – having the code out in the open to review, improve with physician input?). This is not a novel concept and the only ones who can make a choice and break away from this proprietary with or without certification duopoly are the end users themselves – patients and physicians.

As others have pointed out in other related blog posts on this site, we can’t realistically go back to pen and paper. We also can’t turn back time to undo the damage and $$$ lost with MU. With our political climate, we can’t hope and wait for legislation to turn things around in the next few months or even years. It’s in our hands. The tools are there for us. It’s not a theoretical proposition. We need to seriously talk about the prospect of open source and for those that are unfamiliar with it, get immersed and get to know more about it. It costs nothing and you can try it out (HIE and One and NOSH) and start that conversation. These open source projects only thrive if a community supports it. To me, the key value propositions of a meaningful open source health project are better patient care with happier physicians like me who are back in the business of taking care of their patients. Just that simple.
- Michael Chen, MD
I'm not persuaded that Open Source applications (and I happily use Firefox, Thunderbird, and Filezilla, to cite just three), as effective as they can be generally, represent the HIT panacea (Wiki list of open source Health IT here). A bit of false dilemma there, IMO. I began my white collar career in the 80's writing (what would now be called) "apps" in a forensic-level environmental radioanalytical lab in Oak Ridge (e.g., here, pdf). While my work was "proprietary" (IT/ORL was a privately-held commercial lab) the comprehensive QA packages having to be thoroughly reviewed and signed off by my Sups (inclusive of SOPs, source code, RDBMS schema, logic flowcharts, and validation sample data) before any of my work could be put into production were routinely available to hordes of regulatory and client examiners. I've been audited right down to my rounding algorithms, frequently under adversarial conditions. I've long been a critic of the feebleness of the simplistic and toothless ONC cert program.

A prior comment (same thread) at THCB:
ONC policy is the root of the problem and has caused the general erosion of trust in federal health initiatives that we have today.

Certification is a poor substitute for sunshine. The reason we have cheating in Volkswagen or eCW is that software that impacts our health is not open source. However, the harm of secrecy is clearer when the software can produce a medical error directly rather than just statistically impact our health through environmental damage.

Certification institutionalizes the growing practice of making medicine itself proprietary and secret. Open source medical software, like medical knowledge itself, is safe and trusted because it’s open to peer review and has no economic incentive to hide bugs or to cheat. On the contrary, open source software creates the incentive for bugs and shortcuts to be publicized in the hope that they will be quickly fixed. This is how medicine works as well, where we understand the critical importance of reporting adverse events.

My colleague Michael Chen, MD has authored the New Open Source Health (NOSH) EHR that’s at the core of our HIE of One initiative. His comments about certification and ONC policy in April and our other posts before predicted the failure of confidence that we are seeing with eCW and ONC today:

ONC policy to protect proprietary EHRs by erecting a certification barrier to open source software is the root of the problem. As Michael notes, it’s also the root of the “information blocking” / interoperability problem we have. How many lives and hundreds of $Billions is that costing us? Adding more regulations by certifying more secret software will not solve the problem of trust. Our physicians need to be using tools that are open to inspection, free to teach, to share, and to improve. It’s medicine.
- Adrian Gropper, MD
All points well-taken. But, still, I have false dilemma reservations. And I'm a bit put off by Dr. Gropper's imputations of ONC ill will and "regulatory capture" ulterior motives.

BREAKING: The VA just selected Cerner for their new EHR system. So much for Open Source (VistA).


From HealthcareDIVE:
eClinicalWorks false claims settlement could kick off more EHR investigations

Dive Brief:
  • Legal experts believe the recent $155 million settlement with EHR vendor eClinicalWorks in a False Claims Act case may be the start of greater Department of Justice (DOJ) activity in the EHR field.
  • FierceHealthcare reported that eClinicalWorks isn’t the only vendor that has “taken liberties with certification criteria” and Healthcare IT News predicted DOJ will shine the light on other EHR vendors for false claims.
  • The DOJ obtained more than $4.7 billion in settlements and judgments from civil cases that involved the False Claims Act last fiscal year. The DOJ has averaged nearly $4 billion on False Claims Act cases since fiscal year 2009 and has collected $31.3 billion during that period...
What a mess.

More to come...

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