Free EMR Newsletter Want to receive the latest news on EMR, Meaningful Use, ARRA and Healthcare IT sent straight to your email? Join thousands of healthcare pros who subscribe to EMR and HIPAA for FREE!!

EHR Certification Flexibility Final Rule Commentary and Analysis

Posted on September 3, 2014 I Written By

John Lynn is the Founder of the 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 and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The news came out late on Friday that the EHR Certification flexibility was published as a final rule. I covered my initial take on the EHR Certification Flexibility on Hospital EMR and EHR. I’ve now had a chance to dig through the delicious 90 pages of government rule making and comments that make up the final rule. For those following along at home, you can skip to page 10 of the document to start the fun read. Although, I’ll also direct you to specific sections that might be of interest to you below.

In this post, I’ll just cover the EHR certification flexibility. You can see the meaningful use extension and delay timelines here. Here’s the important chart when talking about the EHR Certification flexibility (CMS Calls it CEHRT):
2014 EHR Certification Flexibility - CEHRT

The EHR Certification flexibility has a number of major talking points:

  • What Does “unable to fully implement” and “2014 Edition CEHRT availability delays” mean?
  • Fairness of EHR Certification Flexibility
  • 90 Day Reporting Period in 2015 Instead of 365 Days
  • Future Audits

What Does “unable to fully implement” and “2014 Edition CEHRT availability delays” mean?
On page 62 of the rule is the best description of the rule’s intent. It says that if you want to take advantage of this EHR flexibility, then they (Eligible providers or hospitals) “must attest that they are unable to fully implement 2014 Edition CEHRT because of issues related to 2014 Edition CEHRT availability delays when they attest to the meaningful use objectives and measures.” This basically covers the asterisk in the chart above.

This piece of the rule was so unclear that CMS in the final rule used 12 pages (pg. 36-48) to describe when this rule would apply and when it would not apply. CMS tried to make this apply as broadly as possible, but I think they also wanted to encourage as many organizations as possible to not use the exception.

My short summary of these 12 pages is: If you have the 2014 Certified EHR software and can attest to meaningful use stage 2, then you better go ahead and do it. Trying to find a loophole that allows you to avoid meaningful use stage 2 and just do MU stage 1 puts you at risk during a future meaningful use audit.

Of course, if you’re EHR vendor hasn’t provided you the proper software/updates/training, etc that you require to attest to meaningful use stage 2, then this rule will apply. CMS’ intent seems pretty clear. If you can attest to meaningful use stage 2, then you should. However, if your EHR vendor prevents you from being able to attest, then they don’t want to hold the providers accountable for the EHR vendors failure. Although, CMS notes multiple times in the final rule that they don’t want to point blame at the EHR vendors since it could have been other outside issues (ie. final rule was late, ONC-ACB’s were backlogged, etc) that caused the EHR vendors to not be ready.

I wonder if one of the unintended side effects of this rule will be EHR vendors taking their sweet time releasing and rolling out their 2014 Certified EHR product and updates. It’s too late for this in the hospital setting since hospitals have to do a full year of MU 2 on a 2014 Certified EHR starting October 1, 2014. However, the same might not be true on the ambulatory side where they have until the end of the year to start on meaningful use stage 2.

I’ll be interested to see how many organizations are able to take advantage of this delay. Had this rule been finalized in early 2014, it would be a very different story. However, at this late date, I’m not sure that many providers or hospitals will be able to change course.

I mostly feel bad for those organizations that rushed their EHR implementations onto barely-beta-tested 2014 Certified EHR software and will now have no choice but to go forward with meaningful use stage 2. This change in rule makes many of these organizations wish they’d slowed their implementation to make sure they’d done it right and they’d have also only been required to do MU stage 1.

Fairness of EHR Certification Flexibility
The last paragraph above highlights part of the reason why many providers feel that this EHR certification flexibility is unfair. While it’s not a direct penalty on organizations that were on top of things, the change rewards those organizations that didn’t take the risks, push their EHR vendors, and push their implementation timelines to meet the MU stage 2 requirements. The reward an organization gets for going after MU stage 2 is that they have to do a lot more work (Yes, MU2 is A LOT more work) while their procrastinating competitors get to do the much simpler MU1.

This was such an important complaint that CMS addressed these comments in two different places in the final rule (pg. 21-22 and pg. 48-50). CMS tries to argue that in their research they didn’t see providers that were deliberately trying to delay MU stage 2, but found that providers wanted to do MU stage 2, but their EHR vendors weren’t ready. I’d suggest that CMS may want to dig a little deeper.

However, let’s set providers aside for now and assume that they all want to do MU stage 2, but their EHR vendors just aren’t ready for it. This EHR certification flexibility still lets EHR vendors who procrastinated their 2014 EHR certification off the hook. In fact, it rewards them and their users for not performing well. Once again, CMS doesn’t want to point the finger at EHR vendors, but will blame themselves for not finalizing the rule fast enough and ONC-ACB’s for having a backlog. However, if you’re an EHR vendor who’s been 2014 Certified for a while now, no doubt this rule makes you angry since it rewards your competitors in a big way (intended or otherwise).

Certainly there are a lot of reasons why an EHR vendor isn’t yet ready to be 2014 Certified. However, most of them have little to do with the rule making process and the EHR certification backlog. Some freely admit it, and others hide behind excuses. I think CMS realized this EHR Certification flexibility would benefit these EHR vendors, but they didn’t want to punish the providers who use these EHR software.

I still think the simple solution here was to extend this same flexibility to all providers and all EHR vendors. However, in the final rule CMS argues that doing so would reduced the amount of meaningful use stage 2 data that they’d have available to make the adjustments needed to meaningful use stage 3. I understand how a provider doing MU stage 2 this year might feel like the government’s guinea pig. We need you to do MU stage 2 so we can figure out how to make it right in MU stage 3. CMS also argues that they need more people on meaningful use stage 2 in order to push their agenda and the intent of the HITECH act forward. What doesn’t seem aligned to me is the goals of meaningful use and providers’ goals. I think that’s why we see such a disconnect.

90 Day Reporting Period in 2015 Instead of 365 Days
This seems to be one of the most heated discussion points with the final rule. CHIME President and CEO, Russell P. Branzell, even suggested that “Now, the very future of Meaningful Use is in question.”

CMS’ comments about this (pg. 34-36) basically say that a change to the EHR reporting periods was not part of this proposed rule. Then, they offered this reason for why they’re not considering changes to the reporting periods:

We are not considering changes to the EHR reporting periods for 2015 or subsequent years in this final rule for the same reasons we are not considering changing the edition of CEHRT required for 2015 or subsequent years. Changes to the EHR reporting period would put the forward progress of the program at risk, and cause further delay in implementing effective health IT infrastructure. In addition, further changes to the reporting period would create further misalignment with the CMS quality reporting programs like PQRS and IQR, which would increase the reporting burden on providers and negatively impact quality reporting data integrity.

What this comment doesn’t seem to consider is what will happen if almost no organizations choose to attest to meaningful use because of the 365 day reporting period. Talk about killing the “forward progress” of the program. From a financial perspective, maybe that’s great for the MU program. CMS will pay out less incentive money and they’ll make back a bunch more money in the eventual penalties. However, it seems counter to the goal of increasing participation in the program. Personally, I’m not sure that the end of organization’s participation in meaningful use would be such a bad thing for healthcare. It would lead back to a more rationale EHR marketplace.

Future Audits
On page 55-56, the final rule addresses the concerns over audits. We can be sure that some organizations will be audited on whether they were “unable to fully implement 2014 Edition CEHRT because of issues related to 2014 Edition CEHRT availability delays.” Sadly, the final rule doesn’t give any details on what documentation you should keep to illustrate that you meet these requirements for which you will have to attest. The final rule just says that they’ll provide guidance to the auditors on this final rule and that audit determinations are finalized on a case by case basis that will cover the varied circumstances that will exist.

This wouldn’t give me much comfort if I was going through an audit. Not to mention comfort that the auditors wouldn’t interpret something differently. I’ll defer other audit advice to my auditor friends, since I’m not an audit expert. However, in this case you likely know how far you’re stretching the rule or not. That will likely determine how comfortable you’ll be if an audit comes your way. Now you can see why my advice is still, “If you have the 2014 Certified EHR software and can attest to meaningful use stage 2, then you better go ahead and do it.

I really see the meaningful use program on extremely shaky ground. I don’t think this final rule does much to relieve any of that pressure. In fact, in some ways it will solidify people’s bad feelings towards the program. We’ll see for sure how this plays out once we see the final numbers on how many organizations attest to meaningful use stage 2. I don’t think those numbers are going to be pretty and 2015 could even be worse.

Note: For those following along at home (or work), here’s the final rule that I reference above.

Eyes Wide Shut: Meaningful Use Stage 2 Incentive Program Hardships

Posted on March 5, 2014 I Written By

Mandi Bishop is a hardcore health data geek with a Master's in English and a passion for big data analytics, which she brings to her role as Dell Health’s Analytics Solutions Lead. She fell in love with her PCjr at 9 when she learned to program in BASIC. Individual accountability zealot, patient engagement advocate, innovation lover and ceaseless dreamer. Relentless in pursuit of answers to the question: "How do we GET there from here?" More byte-sized commentary on Twitter: @MandiBPro.

In my January update on Meaningful Use Stage 2 readiness, I painted a dismal picture of a large IDN’s journey towards attestation, and expressed concern for patient safety resulting from the rush to implement and adopt what equates to, at best, beta-release health IT. Given the resounding cries for help from the healthcare provider community, including this February 2014 letter to HHS Secretary Kathleen Sebelius, I know my experience isn’t unique. So, when rumors ran rampant at HIMSS 2014 that CMS and the ONC would make a Meaningful Use announcement, I was hopeful that relief may be in sight.

Like AHA , I was disappointed in CMS Administrator Marilyn Tavenner’s announcement. The new Stage 2 hardship exemptions will now include an explicit criteria for “difficulty implementing 2014-certified EHR technology” – a claim which will be evaluated on a case-by-case basis, and may result in a delay of the penalty phase of the Stage 2 mandate. But it does nothing to extend the incentive phase of Stage 2 – without which, many healthcare providers would not have budgeted for participation in the program, at all, including the IDN profiled in this series. So how does this help providers like mine?

Quick update on my IDN’s progress towards Stage 2 attestation, with $MM in target incentive dollars at stake. We must meet ALL measures; there is no opportunity to defer one. The Transition of Care (both populating it appropriately, and transmitting it via Direct) is the primary point of concern.

The hospital EHR is ready to generate and transmit both Inpatient Summary and Transition of Care C-CDAs. The workflow to populate the ToC required data elements adds more than 4 minutes to the depart process, which will cause operational impacts. None of the ambulatory providers in the IDN have Direct, yet; there is no one available to receive an electronic ToC. Skilled resources to implement Direct with the EHR upgrades are not available until 6-12 weeks after each upgrade is complete.

None of the 3 remaining in-scope ambulatory EHRs have successfully completed their 2014 software upgrades. 2 of the 3 haven’t started their upgrades. 1 has not provided a DATE for the upgrade.

None of the ambulatory EHRs comes with a Clinical Summary C-CDA configured out-of-the-box. 1 creates a provider-facing Transition of Care C-CDA, but does not produce the patient-facing Clinical Summary. (How did this product become CEHRT for 2014 measures?) Once the C-CDA is configured, each EHR requires its own systems integrator to develop the interface to send the clinical document to an external system.

Consultant costs continue to mount, as each new wrinkle arises. And with each wrinkle, the ability to meet the incentive program deadlines, safely, diminishes.

Playing devil’s advocate, I’d say the IDN should have negotiated its vendor contracts to include penalty clauses sufficient to cover the losses of a missed incentive program deadline – or, worst case scenario, to cover the cost of a rip-and-replace should the EHR vendor not acquire certification, or have certification revoked. The terms and conditions should have covered every nuance of the functionality required for Stage 2 measures.

But wait, CMS is still clarifying its Stage 2 measures via FAQs. Can’t expect a vendor to build software to specifications that weren’t explicitly defined, or to sign a contract that requires adherence to unknown criteria.

So, what COULD CMS and the ONC do about it? How about finalizing your requirements BEFORE issuing measures and certification criteria? Since that ship’s already sailed, change the CEHRT certification process.

1. Require vendors to submit heuristics on both initial implementation and upgrades, indicating the typical timeline from kick-off to go-live, number of internal and external resources (i.e., third-party systems integrators), and cost.
2. Require vendors to submit customer-base profile detailing known customers planning to implement and/or upgrade within calendar year. AND require implementation/upgrade planning to incorporate 3 months of QA time post-implementation/upgrade, prior to go-live with real patients.
3. Require vendors to submit human resource strategy, and hiring and training program explicitly defined to support the customer-base profile submitted, with the typical timeframes and project resource/cost profiles submitted.
4. Require vendor products to be self-contained to achieve certification – meaning, no additional third-party purchase (software or professional services) would be necessary in order to implement and/or upgrade to the certified version and have all CMS-required functionality.
5. Require vendor products to prove the CEHRT-baseline functionality is available as configurable OOTB, not only available via customization. SHOW ME THE C-CDA, with all required data elements populated via workflow in the UI, not via some developer on the back-end in a carefully-orchestrated test patient demo script.
6. Require vendor products adhere to an SLA for max number of clicks required to execute the task. It is not Meaningful Use if it’s prohibitively challenging to access and use in a clinical setting.

Finally, CMS could redefine the incentive program parameters to include scenarios like mine. Despite the heroic efforts being made across the enterprise, this IDN is not likely to make it, with the fault squarely on the CEHRT vendors’ inability to deliver fully-functional products in a timely manner with skilled resources available to support the installation, configuration, and deployment. Morale will significantly decline, next year’s budget will be short the $MM that was slated for further health IT improvements, and the likelihood that it will continue with Stage 3 becomes negligible. Vendor lawsuits may ensue, and the incentive dollar targets may be recouped, but the cost incurred by the organization, its clinicians, and its patients is irrecoverable.

Consider applying the hardship exemption deadline extension to the incentive program participants.