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New EHR Certification Rules Including Self-Declaration – MACRA Monday

Posted on September 25, 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.

This post is part of the MACRA Monday series of blog posts where we dive into the details of the MACRA Quality Payment Program (QPP) and related topics.

Elise Sweeney Anthony and Steven Posnack recently announced on the ONC Health IT Blog two major changes to the EHR certification program. In some ways, it shows a maturity of the EHR certification program, but in other ways, it’s ONC kind of taking a more hands off approach to EHR certification.

Here are the two big changes they made:

  1. Approving more than 50% of test procedures to be self-declaration; and
  2. Exercising discretion for randomized surveillance of certified health IT products.

The first one is really fascinating since they’re making 30 out of the 55 certification criteria as “self-declaration only.” That basically means that EHR vendors will just have to claim they meet the requirements. The ONC-ACBs won’t be certifying those 30 test procedures. In many ways, it reminds me of the meaningful use self-attestation. Does that mean that ONC-ACBs will cut their costs in half? Don’t be holding your breath on that one.

Let’s just hope that most EHR vendors don’t self-certify the way eCW approached EHR certification. Although, the eCW EHR certification issues are the perfect example of why a company self certifying their EHR software or the ONC-ACB certifying the EHR software is just about the same. I haven’t seen which test procedures will be self-declared, but my guess is that it was the ones that the ONC-ACBs weren’t really doing much to test and certify anyway. Ideally, this will free up the ONC-ACBs to dive deeper into the 25 test procedures they’ll still complete so they can avoid another eCW like incident.

Some might wonder why we don’t just take the self-declared EHR certification tests altogether if there’s no one that’s going to be checking them. What those people miss is that the self-declaration still keeps the EHR vendors on the hook for properly implementing the EHR certification criteria. If it’s discovered that they claimed to be compliant but aren’t, then the government can go after the EHR vendor for false claims.

The second change has me a little more puzzled. I’m not sure why they would want to release ONC-ACBs from the requirement to randomly audit EHR certifications. Maybe they didn’t discover any issues during their random audits and so they didn’t see a need to continue them. Or maybe the ONC-ACBs said they were going to pull out as certifying bodies if the government didn’t lighten the EHR Certification load. This is all conjecture, but they could be some of the reasons why ONC decided to make this change. They did offer the following insight into their reasoning:

This exercise of enforcement discretion will permit ONC-ACBs to prioritize complaint driven, or reactive, surveillance and allow them to devote their resources to certifying health IT to the 2015 Edition.

I wonder how many complaints the ONC-ACBs have gotten about the EHR software they’ve certified. Have they just been so overwhelmed with complaints that they need more time to deal with those complaints and so audits aren’t needed? I’d be surprised if this was the case. At this point I imagine most people with EHR certification issues will be calling the whistle blower attorneys, but I could be wrong.

All in all, I don’t think these EHR certification changes are a huge deal. It’s largely a maturing of the EHR certification program and does little to help the EHR certification burden on software vendors. Maybe the ONC-ACBs will charge a little less for their certification, but that’s always been a negligible cost compared to the development costs to become a certified EHR. I’m sure the ONC-ACBs are happy with these changes though.

What do you think of these changes? Any other impacts I haven’t described above that we should consider?

Interview with ICSA Labs About EHR Certification

Posted on January 31, 2014 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.

After hearing the news about CCHIT shutting down it’s EHR certification business, I thought it would be interesting to interview ICSA Labs, the EHR Certification body that CCHIT recommended to its users. The following is an interview with George Japak, Managing Director at ICSA Labs.

Is there a backlog of EHR vendors that want to schedule test dates with ICSA labs?  

A: There is no backlog. Since ICSA Labs received its ONC authorization, it has been our intent to grow our healthcare programs and offer the best testing and certification program in the industry. Over time we have ramped up our testing team and we have a deep pool of very experienced testers on staff. We have been getting a steady stream of news customers and inquiries and expect the CCHIT announcement will accelerate the pace.  At this point we have the capacity to test applicants as they are prepared to do so.

Is ICSA Labs able to support the onslaught of EHR companies that will come over from CCHIT?  Will that cause any delays on getting EHRs certified?

A: ICSA Labs at this point does not anticipate any delays. The ONC program was designed so that vendors and product developers would have a choice when it came to testing and certification. We were not the first lab to be authorized, but we knew that given the opportunity we would be able to deliver a program where customers would experience high satisfaction.

In my post, I suggested that the economics of EHR certification aren’t all that great.  Especially if you have a legacy cost structure like CCHIT.  Is the secret to ICSA’s success having a broader certification business beyond just EHR?

A: ICSA Labs has been in business since 1989, we have a number of accreditations to support an array of certification and testing programs, such as the IHE USA Certification program which just kicked off its second year at the 2014 IHE North American Connectathon. Our business is diverse and we leverage our capabilities across our business. We are used to doing business in competitive markets, so it has always been important for our programs and cost structure to emphasize efficiency and effectiveness and those benefits are passed onto our customers. Our testing and certification programs have always been competitively priced and efficient yet rigorous and done superior quality.

How much more complex is 2014 EHR certification compared with 2011 from an ONC-ACB perspective? 

A: As any recently certified company can attest to, the 2014 Edition criteria are significantly more complicated than the 2011 Edition. There are more test tools to maintain; more test data sets to review; frequent revisions and updates to the criteria and additional types of attestation to review. The time to complete testing has close to doubled and there are more requirements as they pertain to surveillance. After the 2011 Edition criteria, ICSA Labs asked for ONC to raise the bar, and they did. For ICSA Labs the added complexity was not unexpected.

The timelines for meaningful use stage 2 are starting to get squeezed.  Will the majority of EHR vendors be 2014 certified and ready in time?

A: There will always be stragglers, but I believe a majority of EHR vendors will be 2014 certified and ready in time for Meaningful Use 2. There has been an uptick in the vendors getting certified over the last few months. Providers and hospitals however are a different story, and they may feel the squeeze in terms of the timeline to purchase, implement and begin meaningfully using their EHR system. ONC extended the Stage 2 timeline to relieve some of that pressure.

I’ve heard that in some cases the ONC-CPHL has been slow at putting up newly certified EHRs.  Have you seen this?  Do you have a bunch of 2014 certified EHR vendors that haven’t been listed on ONC-CPHL yet?

A: The ONC-CHPL is generally responsive to our concerns and we work with them as they continue to refine new features like links to the public test results summary.