My understanding is that Oracle's new EHR can certify itself.
EClinicalWorks Will Pay $155 Million to Settle DOJ False Claims Act Allegations
EClinicalWorks will pay $155 million to settle a federal False Claims lawsuit alleging that ECW misrepresented its EHR product and paid customers kickbacks for promoting it, the Department of Justice announced today.
The government claims that ECW fraudulently obtained certification for its EHR by hard coding some of the testing elements as provided to its certifying entity. It also says ECW’s software did not accurately maintain a user audit log, did not reliably record diagnostic imaging orders, failed to perform drug interaction checks, and failed to meet interoperability requirements, thus causing false claims for HITECH incentive payments to be paid by HHS.
According to ONC’s Certified Health IT Product List, ECW’s Authorized Certification Body is Drummond Group.
The company and three of its founders will pay the $155 million settlement.
ECW also entered into a five-year HHS OIG Corporate Integrity Agreement that requires the company to have its software quality control systems externally audited and reported to HHS OIG. The company also agreed to provide prompt notice to customers of any EHR-related safety issues, to make software updates available at no cost, and to assist customers in migrating to other EHRs without charging them. ECW is also required to hire an Independent Review Organization to certify that the company’s agreements with providers comply with anti-kickback laws.
The whistleblower lawsuit was filed by Brendan Delaney, a software technician with New York City Division of Health Care Access and Improvement, who will receive $30 million of the settlement.
I’ve run several reader-provided rumors about the Department of Justice investigation, going all the way back to late 2015.
Oh, boy…
Can’t say I am surprised. After working with over forty vendors taking them thru the Cert process it was clear to me you could hard code results, doctor up screens, link to non-cert software, etc. and given the meek audit process the only way you’d get caught is via a whistle blower.
This will clearly empower more whistle blowers, if you are a vendor that played this game…your going to be losing alot of sleep!
$155 million fed fines, and I bet there will be big lawsuits coming from the providers, could be the end of ECW!
Hmmmmm. So, Mr. Poggio, if “it was clear to [you], you could hard code results, doctor up screens, link to non-cert software, etc. and given the meek audit process the only way you’d get caught is via a whistle blower”, I’m wondering if you ever shared that information and your insights with the appropriate persons to point out the weaknesses in the certification process?
I sure hope so!
Yes I did. Mentioned it on this and other blogs in 2009-10. Also made comments when CMS/ONC published draft rules. But as usual, it was not a priority for anyone. Hey, feds said HiTech program was going to save $800 Billion, so why worry about a few kick backs and rogue players?
Word. The ease with which the cert process can be gamed is kind of ridiculous. Drummond could easily catch things like this by randomizing the codes they look for during the actual testing process, and just using the published tests as a QA tool for vendors.
ECW put millions of children and adults at risk–missing medication checks, wrong lab values, etc.–this may have already killed someone which is the scariest part.
How do we know that their bad data didn’t lead to the wrong drug or wrong procedure being done? How do we know this didn’t lead to a wrongful death?
How does any patient, MD, or executive ever trust them again?
My child’s ped uses ECW, he wont be going there anymore.
Sad!
Good luck finding an EHR company that hasn’t gamed the system.
So, what will this mean for those of us who have been eCW users for years and have attested to multiple years of MU and PQRS using eCW data?
This news about eClinicalWorks is interesting but not surprising. With the stake involved at the time, I am sure they were not the only company to do this. However, what does this say about the rigor or lack of, of the third party certification process? Will the providers how attested need to return their payments.
I’m guessing the $155 million doesn’t include any incentive payments that eCW clients received from CMS. To try and recoup incentive payments from clients wouldn’t exactly be fair – their vendor “certified” the application; how were clients supposed to know it was faked? DOJ should go after eCW for that money as well.
How do you even try and sell your EHR now – “eClinicalWorks, now with 100% more certifiedness” or “we’re CEHRT for real this time” doesn’t have quite the marketing zing to it.
If anything this has really opened my eyes to the certification process, as I understood the testing to be more much rigorous and could span multiple different workflow scenarios to avoid situations just like this. Talk about an open book exam – do we know who the certifying body was? Are they culpable in this situation for not realizing things were propped up?
Drummond was the certifying body.
From the HISTalk Post: “According to ONC’s Certified Health IT Product List, ECW’s Authorized Certification Body is Drummond Group.”
It really doesn’t matter how they market it. Everyone already bought an EHR so they can’t sell them another one….
Drummond is the certifying body, the report says so.
Good luck finding another EHR company that hasn’t done the same thing, though.
Based on absolutely no evidence.
Again, time to stop ALL cert for EHR. Let the real market work. Cert was the nanny state protection for MDs about functionality of EHRs. Right…… Anyone that has worked on any cert EHR knows that the Cert Requirements had to have been faked. Get ready Cerner/Epic for some lost sleep.
All EHR vendors did is do their very best to beat the test and unleash their costly “cert” EHR on MDs. We would have been better to just let EHR companies ACTUALLY work with MDs and end users for IT that we want and need, not what “cert” needed.
Its time to END EHR cert. Its useless anyway and certainly this will NOT be the last big black eye for the cert process.
When will we ever learn that if we get Wash DC involved, we are setting up the program for failure. We really need to get Wash DC out of the HIT EHR Medical regulation world.
If a company with millions of $’s at their disposal can’t pass certification without cheating, how can fledgling, innovative EHR companies meet the requirements?
Time to do away with EHR meaningless use and certification !
They can, they just can’t do it in ridiculously short timelines that are driven by marketing and PR needs, rather than physician needs. The certification requirements aren’t all that outlandish, they just take time to implement and test correctly (figure: about a year).
$155M is far too little for this.
52,000 eCW providers claimed ~$2 BILLION of CMS incentives.
And the punishment is that they have to pay back less than 10% of that amount?
Can you explain how you came up with 2 billion in CMS incentives?
52,000 providers x $40,000 each.
It’s easy to quibble with the math (since this was 2013/2014, should you only count payments in that timeframe? etc), but there is no doubt that CMS paid far more than $155M in incentives.
The DOJ settling for pennies on the dollar and no criminal prosecution is unbelievable.
Clearly, they’re correcting the issues….
As a former employee of an EHR company, I can certainly say the certification process was such a boondoggle. Not only did it force EHR companies that were doing good work to stop listening to their customers, it forced them to stop innovating. So we now have a bloated mess of EHRs. As Farzad Mostashari pointed out, eCW is not the only one out there that falsified their data to get past the certification.
And Farzad was an architect of this MU Cert policy. Hypocrisy?
He forced HIT vendors into a rabbit hole of useless cert requirements, touted that it was necessary to protect MDs and patients and yet HE KNOWS it was gamed by many? That sounds criminal to me.
Oh yeah, he’s not blameless either. Totally agree.
He’s an insider who helped create policy which benefited him when he joined the private sector.
so who received kickbacks? they should go to the slammer…
Having sold higher priced EHRs for 12 years prior to HITECH and competing against eCW, I’m not totally surprised. When a prospect asked eCW about functionality the answer was always yes or yes we will add it.
This included creating a screen or drop down selection with very little functionality underneath it. This is one of the ways they were able to undercut other EHR vendors prices.
What is surprising is the number of areas where they faked it for HITECH.
Was there ‘collusion’ (overused word of the year) with software engineers at VW on how to beat government tests?
There’s an awful lot of “Good luck finding any vendor who didn’t do the same thing” in this thread (though admittedly coming from a small, but vocal group of people). There’s a false equivalency between “gaming a system” and “cheating a system.” One operates within the letter of the law or rules of the system, but exploits flaws in those systems. The other just fakes results to make it appear as though it’s compliant. So even if there’s evidence that all the vendors are gaming the system (which no one here is showing), there’s still a big difference between those that do and those that cheat the system. So if you think all the other vendors are doing the same thing, I think the burden of proof is on you to provide it. I’ve been working with one of those vendors on these systems for years, and they’ve consistently met the measures without cheating the system, so there’s no doubt in my mind that they aren’t all doing the same thing.
EHR innovation being stifled by MU???
Pu-leeez. Collectively there was little innovation from the vendors pre-MU. MU pushed them in this direction… no matter how convoluted the law is.
Even in 2017, EHR technology is just progressing to circ 2000s. It’s pathetic with so much money they can’t come up with something even remotely modern. Pathetic.
Yeah, I mean where are my Candy Crush mobile games in the EHR? So boring.
I would not paint all vendors with the ECW brush. As mentioned I worked with over 40 of them (big and very small) and not one of them did what ECW did. As crazy as it may have been they wrote real code to do what was needed..even though they may have hated the process!