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eClinicalWorks Faces Additional Fine For Violating Terms Of Fraud Settlement

Posted on August 10, 2018 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

In mid-2017, the news broke that EHR vendor eClinicalWorks had agreed to pay $155 million to settle a whistleblower lawsuit brought by a former employee. The government had accused the company of doctoring its code to cover the fact that its platform couldn’t pass certification testing,

Following the agreement with the government, eCW was hit with two class-action lawsuits related to the certification fraud, one filed by a group of clinicians over funds lost due to the certification and another by patients who say that data display errors may have affected their care.

Unfortunately for eCW, its legal troubles aren’t over. The vendor is now on the hook for a fine it incurred for failing to comply with the Corporate Integrity Agreement it signed as part of its settlement deal. The $132,500 fine probably won’t have a massive impact on the company, but it’s a reminder of how much trouble the certification problem continues to cause.

In signing the CIA, which will be in place for five years, eCW agreed to a number of things, including that it would adhere to software standards and practices, identify and address patient safety and certification issues and meet obligations to existing and future customers. eCW also promised to report patient safety issues in a timely manner.

Apparently, it didn’t do so, and that triggered the penalty stipulated in the CIA. Among the terms buried in the hefty CIA document is that the vendor would be fined $2,500 for each day eCW failed to establish and implement patient safety issues as reportable events. Somehow, the vendor let this go for almost two months. Bummer.

Of course, eCW leaders must be reeling. This has to have been the most painful year in the company’s history, without a doubt. Customers are understandably quite angry with eCW, and some of them are suing. Patients are suing. Its reputation has taken a major hit.

The financial implications of the settlement are staggering too. Very few companies could cover a $155 million payout without a struggle, and even if a business liability insurer is covering the loss, the settlement can’t be good for its relationships with financial institutions. It’s a mess I’d wish on no one.

On the other hand, am I being too harsh when I suggest that under the circumstances, letting a reporting problem go for 53 days doesn’t speak well of eCW’s recovery? Yes, I’m sure that keeping up with CIA requirements has been pretty burdensome, but we’re talking about survival here.

I’m not going to hazard a guess as to whether eCW is on the skids or just struggling to recover from a massive blow to its fundament. But geez, folks. Let’s hope you get on top of these issues soon. Violating the terms of the CIA within year two of the five-year agreement doesn’t exactly inspire confidence.

In The Hot Seat Again: eClinicalWorks Faces Billion-Dollar Suit Over Alleged Software Problems

Posted on November 27, 2017 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Earlier this year, eClinicalWorks agreed to pay $155 million to the U.S. Department of Justice to resolve allegations that it had faked its conformance with Meaningful Use criteria. The DoJ suit alleged that by withholding information needed for certification, eCW violated the False Claims Act.

Now, the vendor is facing what could be an even more serious legal threat, according to a news report appearing in Becker’s Hospital Review. BHR is reporting administrator of the estate of a deceased cancer patient is suing the vendor over data display errors that may have affected the patient’s care.

What makes the stakes so high in this case is that the complaint is asking the court to certify the case as class action, with members to include “all persons residing in the United States whose physicians used eCW to record and store their medical records at all dates relevant.” The suit is asking the court to award plaintiffs $999 million in damages, Becker’s Hospital Review reports.

According to the complaint, which was filed by Kristina Tot, administrator of the estate of the deceased Stjepan Tot, errors with eCW software began to appear before the cancer patient’s death. For example, “he was unable to display his medical history or progress notes,” the complaint reportedly states.

The cancer patient’s problems were far from unique, however, the suit asserts. According to the complaint, important eCW software functions didn’t work or violated regulatory guidelines. The filing claims the vendor didn’t provide accurate and reliable health information, displayed incorrect panels and didn’t record EHR user actions in audit logs.

The bottom line, the suit claims, is that millions of patient records were compromised, leaving patients and physicians unable to rely on the eCW platform.

I am not qualified to speak on whether there’s any merit to the latest suit against eCW, though I think it’s reasonable to assume that the company may not have its act together. (You might also want to check out the angry eCW critiques on this site — whose publisher, like our fearless leader John Lynn, I know to have an impeccable reputation for honesty.)

Ultimately, it’s hard to say whether this latest suit is largely blowback from the previous certification problem or yet another (extremely) costly headache. Either way, if I were part of its leadership team I’d be more than a little shaken by recent events even if the recent complaint gets dismissed.

PDR Certified Help to Determine EHRs That Meet Minimum Drug Safety Requirements

Posted on June 15, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

A new drug safety certification program for EHR and ePrescribing platforms that is supposed to “recognize EHRs that meet minimum drug safety requirements” is in the works, according to a recent press release.

PDR Network, the leading distributor of FDA-approved drug labeling, safety and REMS information, and iHealth Alliance, a not-for-profit organization involved in protecting patients and providers, announced the program, “PDR Certified”, on May 10th. Healthcare providers will be able to determine if the EHR system they use currently or will be purchasing meets minimum drug safety requirements.

Because of the influx of EHRs in recent years, it is more important than ever for there to be certain requirements that must be met to ensure patient and provider safety. Nancy Dickey, the chair of the iHealth Alliance said concerning this:

It is vitally important that these systems include standards for drug safety functionality, and that these standards are easy for busy physicians to identify and understand — fortunately, these goals are shared widely and are in sync with those called for by the FDA.

In order for an EHR vendor to be considered “PDR Certified”, the following functions and features must be included in their product:

1. Full FDA Labeling

2. Drug Alerts and Warnings (Safety Alerts, Boxed Warnings, Recalls and REMS Communications)

3. Adverse Drug Event Reporting

4. FDA-compliant patient education or support services.

Any EHR vendor that becomes “PDR Certified”  can display the logo for “PDR Certified”, which will allow prospective and exisiting customers the opportunity to know they meet requirements above. Dr. David Troxel, Medical Director of the Doctors COmpany, said:

Access to full FDA labeling combined with timely delivery of drug alerts is critical to drug safety in any enviornment but particularly in EHRs which play such a large and growing role in care delivery today. PDR Certification will provide an easy to recognize way for our physician members, and all U.S. providers, to know if they system they are using or evaluating lives up to these drug safety standards.

More information on the program can be found at www.PDRCertified.org.

What do you think of having an EHR Drug Safety certification?

Will Rip and Replace EHR Software Ever Be a Thing of the Past?

Posted on April 25, 2012 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

I heard an interesting statistic a few days ago during a very informative webinar – “The Future of Meaningful Use, EHRs and Accountable Care” – hosted by Greenway Medical’s Justin Barnes. He shared a huge amount of information during the hour-long presentation, but the fact that most stood out to me was that, according to Barnes, between 35 and 50 percent of EMRs will eventually be replaced after just one year of use. (Don’t quote him on the “year,” but I’m pretty sure that’s what he said.) His point being, of course, that providers need to think long and hard about what type of solution they need to fit their workflows before they spend time and money implementing an EMR.

This sentiment was echoed by Kimberly Harding of BCBS Florida in a panel at the iHT2 Summit in Atlanta. As part of a greater discussion on Meaningful Use, she made the comment that just because a healthcare IT product is certified doesn’t mean it’s the best fit for a particular facility.

My takeaway from both of these statements is that providers looking to adopt new healthcare IT tools like EMRs need to take a long, hard look at what their current needs are and what their future needs might be before they even think about demoing products.

They also need to adopt technologies that fit their workflows, not necessarily technologies that have a ton of bells and whistles. Added features won’t do anyone any good if they’re never used properly, never used at all, or used to the detriment of a physician’s productivity.

I kept this sentiment in mind when I read the results of a recent study of 250 hospitals and healthcare systems by consulting firm KPMG. The survey found that “71% of respondents’ organizations are more than 50% finished with their EHR adoptions. Will this 71% be satisfied with their EMRs once fully installed and adopted? How many will realize their product of choice wasn’t the right call? If we apply the Greenway statistic, that could be as many as 125 facilities!

So where is the disconnect? Why are providers making poor choices with presumably the best of intentions? Why has the term “rip and replace” become so well known in healthcare? Are physicians misinformed, or not educated enough? Are they feeling so rushed by Meaningful Use deadlines that they don’t perform proper due diligence? Are vendors part of the problem? If so, shouldn’t they be part of the solution? What role do regional extension centers have to play in all this?

If you have answers, please let me know in the comments below.

Are EMRs the Answer to Small-Practice Challenges?

Posted on March 21, 2012 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

During my recent visit to my daughter’s pediatrician, I was pleasantly surprised to see a computer up and humming along in a corner of the exam room. The last time we had been in, some six months before, that same piece of equipment sat shrink-wrapped (as it had been for a few months even before that), waiting for an eager clinician to tear open its plastic casing and put its digital capabilities to good use.

I had been dreading this particular appointment – our first with the one pediatrician left at the practice. Our usual doctor had left a few month earlier for parts unknown, so I wasn’t sure who – or what – to expect. The advice nurse who made my last minute “work-in” appointment was kind enough to make sure I understood that due to the second doctor’s departure, we would likely wait an extremely long time.

Our wait, which ended up being no longer than usual, gave me time to do a bit of snooping around the new computer. No keys or mouse were touched, but I did notice that NextGen was the practice’s EMR of choice. Yes, the nurse did have her back turned to us as she asked me questions about the reason for our visit and entered responses into the EMR. When I asked her if she liked the new system, she gave a rather noncommittal response in close approximation to “some days I do, some days I don’t.”

I’m guessing she may have bigger issues to deal with, such as assisting the patients of a double-, sometimes triple-booked pediatrician. The single-doc situation made me wonder how much training the practice’s staff had time for before and during go-live. I could certainly believe that follow-up training will take a backseat until a second pediatrician is brought into the fold and everyone gets back to a somewhat normal workload.

So how do small practices in similar situations do it? How do they find time for EMR training when overscheduled? Do vendors often step in and help with extra resources? How long do practices go before hiring additional staff? (That’s an off-topic question, I know, but one I’d still like an answer to.) I’d like to think that in the long run, the new EMR would of course help make everyone more efficient, and us patient parents more satisfied. Let me know what you find out in the comments below.

Finding an EMR Job Champion

Posted on December 14, 2011 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

Earlier this year I had the good fortune (and the support of my employer) to join the Technology Association of Georgia (TAG), an organization that offers interest groups for every possible IT niche you can think of. I’ve attended a few of their health society events, and at every one I’m confronted with statistics and anecdotes surrounding the dearth of qualified healthcare IT professionals in the city and surrounding areas. Much attention at these events is also given to the fact that these professionals are needed now more than ever to help smaller physician practices and larger healthcare systems demonstrate Meaningful Use and achieve associated electronic medical record (EMR) adoption goals.

I’ve commented before on the disconnect between the increasing number of healthcare IT educational opportunities being created by the government and vendors’ willingness (or unwillingness, as the case may be) to hire fresh grads. EJ Fechenda of HIMSS JobMine posed a question related to this conundrum better than I ever could have: “With federal deadlines looming, healthcare organizations need to get moving and there are a lot of job seekers out there ready for the challenge. Are there organizations or companies willing to extend opportunities to these candidates? Is there a training or job-shadowing program that can be used as a best practice for other organizations to implement? Who are the champions already doing this or willing to lead the charge?”

I may have found a champion in Rich Wicker, HIMS Director at Shore Memorial Hospital in New Jersey. Wicker is also an adjunct professor at two HITECH-affiliated community colleges, teaching students who already have strong backgrounds in healthcare or IT the basics of process, analysis, redesign, installation and ongoing maintenance to prepare them for second careers in physician office EMR implementations.

He certainly seems to have a passion for the subject. “I’m devoted to the EMR,” he told me during a recent phone interview. “That’s why I started teaching, really, because I want to see that [adoption] happen so badly.”

He tells me his students are guardedly optimistic about their future job opportunities, which he believes will surge this summer alongside an expected increase in physician adoption of EMRs – six months before the deadline to qualify for Meaningful Use incentives.

As we discussed the state of the HIT job market, we both wondered if what type of organization might have a greater role to play in ensuring that graduate from programs like Wicker’s find jobs.

“We had to really battle our way to get one [software] copy from one EMR vendor,” he explains. “I wish they were more amenable to providing educational software/packages like Apple does throughout all their PCs. I know a few different schools have joined with a vendor. One place I know of is showing Vista, another is showing eClinicalWorks, and another partnered with a local hospital that happens to use Sage.

“I have a relatively limited view, but from what I can see, the vendors are not really engaged with the HITECH student development program. I think they’d probably rather do it themselves.”

“Here’s an idea that I came up with,” he adds. “I’ll throw out the RECs (Regional Extension Centers). That’s another entity that’s funded – it’s kind of their job to get the docs to convert. If they could partner with the colleges and the graduates to possibly divert some of their funding to supplementing the graduates’ income while they worked at a physician practice … So the physician, let’s say, for $5 an hour, they could hire a qualified, certified person. These people are pretty good, too. They know what it is to work. They’ve probably worked 10 or 20 years already, either in IT or in healthcare. So they’re mature employees and highly motivated. They would be great to go in and do a 6-month installation. I think it would be great for the physician if, for $5 an hour, you get somebody that would probably cost you $30 an hour somewhere else.

“Let’s say the student can get another $10 an hour supplemented from the REC or somehow through the government. So they get $15 an hour to go in there … they get four or five months of experience doing an installation and then the physician can make a decision … maybe they ultimately hire the person. That’s just a crazy idea that I had that seemed like the pieces are out there that kind of potentially could work. I sent it into the ONC a couple of days ago.”

Could the RECs have a bigger role to play in ensuring that HITECH graduates gain on-the-job experience and employment? I’d love to hear from any readers out there who may work for or with RECs . Is Wicker’s idea doable? Have we found our champion?

Permanent EHR Certification Program (ONC-ACB) Delayed – Is Meaningful Use Stage 2 Delay Next?

Posted on November 4, 2011 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.

It doesn’t come as much of a surprise to me to see the news (yes it’s a couple days old now) that the permanent EHR certification program (where ONC-ATCB becomes ONC-ACB) has been delayed. It was set to sunset at the end of this year and it would essentially convert into the permanent EHR certification program.

ONC’s Farzad Mostashari put out a letter describing the delay in implementing the permanent EHR certification program in this letter. Here’s one portion of the letter:

ONC pushed the plan back after it consulted with the American National Standards Institute (ANSI), which ONC selected as its approved accreditor (ONC-AA) earlier this year, and the National Institute of Standards and Technology (NIST), which administers the National Voluntary Laboratory Accreditation Program (NVLAP). ANSI and NIST said they needed more time to complete the approval of testing labs and certification organizations and ONC to review the applications of the certifiers.

Part of the reasoning for this was for the permanent EHR certification to coincide with the final rule for meaningful use stage 2. I guess it makes sense.

The real challenge I have when thinking about the change from temporary to permanent status is, what will really change? To me this feels mostly like a bureaucratic requirement as opposed to some change that actually provides some sort of benefit.

Will an ONC-ACB provide something of more value than a ONC-ATCB does now? I think not. Will EHR vendors go through a different process with an ONC-ACB compared with what they do now with the ONC-ATCB? I can’t imagine they will. Seems the only ones that should be concerned with this are the ONC-ATCB’s.

Plus, if meaningful use stage 2 gets delayed, then will the permanent EHR certification get delayed again too? Now your ears perk up. Not because anyone cares about the permanent EHR certification, but because a delay in meaningful use stage 2 would be something of note.

EHR Diamonds and Snakes – EHR Certification Doesn’t Differentiate

Posted on August 18, 2011 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.

Jim Tate posted an interesting and valuable warning today in his post on HITECH Answers. Here’s his warning in a nutshell:

“My warning is about the mistaken belief that because an EHR or Module has been listed on the CHPL site it must be good or even serve an intended purpose with any degree of usability. That is simply not the case and everyone knows it.”

He goes on to provide more detail regarding his caution and warning:

Stage 1 Certification is not a seal of approval. No one should think the list of Certified Products is a list of equals. Quite a few of the applications are excellent and demonstrate elegant approaches to the electronic documentation of health information. Others are poorly designed, cumbersome, and no provider will ever be satisfied using them. The purpose of certification was not to separate the good from the bad. So tread very carefully and know the list of these applications contains quite a few diamonds, as well as a few snakes.

Jim Tate and I have actually spoken in person about this before. In fact, I’ve tried to get him to write a series on my blogs about what makes an EHR a diamond and which makes an EHR a snake. So far he hasn’t taken my bait, but I’ll keep trying.

Jim is spot on though. Don’t confuse EHR certification for anything more than a means to obtain EHR stimulus money. It provides no other real assurance to you as a provider. Run from EHR sales people who tell you otherwise.

Which EHR Certifying Body?

Posted on March 3, 2011 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.

Many of you will probably remember my post about Jim Tate and all his EHR certification experience. As I said in that post, Jim Tate knows his stuff when it comes to the EHR certification bodies (ONC-ATCB). So, I found his advice for EHR vendors on HITECH Answers pretty interesting when it comes to selecting which ONC-ATCB an EHR company should use.

You can go read the whole article, or here’s the Cliff notes version: Responsiveness and Support of the EHR certifying body is most important.

EHR Certification Expert – Jim Tate

Posted on February 17, 2011 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.


I’ve had a number of EMR companies ask me where they can get help to become a certified EHR. There’s certainly plenty of resources online, but I find that most EMR companies want some real hands on experience and help to be able to navigate the EHR certification process. Whenever I’m asked this question, I always tell those people to go and talk with Jim Tate.

I still remember when I first met Jim Tate at HIMSS last year. I was hanging around the HIMSS exhibit floor because I was early to a meeting with a vendor. I’m sure I was in a partially lost state since I was trying to figure out what to do with the few minutes I had available before my meeting when I heard someone say my name.

I looked up from my lost state to see who was saying my name and saw an all too familiar face for which I couldn’t place. The person then said, “You’re techguy right?” (I’m @techguy on Twitter, and @ehrandhit as well). Then, everything clicked and I said, “You’re Jim Tate right?” See the funny thing was that Jim and I had never met in person, but obviously both of us had seen each others healthcare IT tweets many times before (I think he enjoyed reading my rips on CCHIT pre-HITECH). It’s always interesting (and usually fun) to meet someone in person that you feel like you already know online.

Personal stories aside, I’ve still gotten to know Jim Tate more online than I did in person. I hope that will change at HIMSS this year. Even if it’s just running across Jim on the HIMSS exhibit floor or one of the various parties. Jim has an incredible amount of knowledge and experience in EMR certification. I’m not sure what it says about me that I find the idea of sitting around with Jim listening to old EMR certification “war stories” to be really interesting.

Of course, what prompted my storytelling about Jim Tate? A tweet Jim recently sent that said he’d worked with 90+ HIT vendors. He has a great EMR certification page on his website which has over 75 Ambulatory and Inpatient EMR vendors that he’s worked with. That’s A LOT of EMR companies. You can see the image of EMR companies he’s helped at the bottom of this post.

One ONC-ATCB recently told me that many of the EHR companies that come to them are incredibly well informed, others are just missing some of the details and others are just completely lost. I’m quite sure Jim Tate’s EMR companies fall into the first category.

Now Jim Tate is starting to share his expertise even more broadly as he partners with HITECH Answer and their Virtual Extension Center. Seems like meaningful use consulting will be Jim Tate and EMR Advocate’s next step and probably a very good one. Or as Jim said it:

Jim also gets my funniest tweet of the year award too. In response to @motorcycle_guy’s tweet about who should replace Dr. Blumenthal as ONC head? Jim replied: