New EHR Certification Rules Including Self-Declaration – MACRA Monday

Posted on September 25, 2017 I Written By

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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?