EHR Certification: Who, What, When, and How Much Will it Cost?

The comment window for a temporary measure that would appoint organizations to test and certify EHR systems has closed, but debate on the final certification program is ongoing.

All of the questions about ONC-authorized testing and certification bodies (ATCB) won't be answered until ONC issues its final rule. But there are hints of what's to come, including who will apply for ATCB status and how much they might charge for the service, as well as some comments that could impact the final rule.

Who will certify?
The Chicago-based Certification Commission for Health Information Technology (CCHIT) came out of the gate early with an announcement that it would apply to become a certifying body. Since then, a few other organizations have stepped up, including the Drummond Group in Austin, TX, and MacPractice in Lincoln, NE.

The ONC hopes to certify up to three organizations, said policy analyst Steve Posnack during a recent HHS Webcast. "We've received early indications that there are at least three entities interested and there could be more," he said. "That's not to say that all of them will actually be qualified at the end of the day, but I think we're seeing a good strong showing of interest that there will be multiple ONC ATCBs."

How will they qualify?
Organizations that want to be ATCBs will submit a request to the national coordinator and indicate the type of authorization sought, such as for complete EHRs and EHR modules, including e-prescribing or clinical decision support modules. They would have to show they understand the certification criteria and standards, that they can properly identify the test tools and methods that are applicable to the certification criteria, and that they can properly use test tools. Once ONC grants ATCB status, it would publish the organization's name and the scope of their authorization.

How much will it cost?
Based on data from CCHIT, certification bodies would likely charge vendors (and ultimately hospitals, since such costs are always passed along to the customer in one form or another) from several thousand dollars to $20,000 for certification of EHR modules to several tens of thousands for complete EHRs.

Theoretically, more organizations in the certification business would mean more competition, which could drive prices down. But for now the government has no plans to regulate prices.

How long will it take?
As potential certifying organizations, vendors, associations, and other groups submit their comments on the proposed rule, one trend has emerged: dissatisfaction with how long it will take to get certification in place.

Although the temporary certification program's 30-day comment period ended April 9, the permanent rule comment period is open until May 10. ONC has said it plans to release the final rule for the temporary certification program at the same time as the final rules for meaningful use stage 1. The permanent certification program is expected to be finalized in the fall.

In its comments to the ONC, The College of Healthcare Information Management Executives (CHIME) says it supports the general concept of moving to a two-stage approach for creating a certification process for electronic health records, but adds significant questions remain.

"It's essential to certify clinical technology quickly yet thoroughly, so that providers can implement applications that will enable them to receive stimulus funds for meaningful use of EHR technology," the organization wrote. "We are very concerned that the introduction of a two-stage approach for certification will prolong the current instability in the health IT marketplace, which exists because of the un-finalized status of meaningful use and certification regulations . . . Above all else, providers need a stable marketplace in which vendors can quickly offer and support implementation of certified products."

Barrington, IL-based GE Healthcare's public comment also urges ONC to speed up the process.

"Time is very short for vendors to make any adjustments to EHR technology to meet certification criteria and processes and then to have certified EHR technology available timely for providers to demonstrate meaningful use during 2011. Software development includes multiple steps to ensure high quality software that is safe for patients. Thus, not only must we have a certification process that can start rapidly with high throughput, it is essential that the final meaningful use and certification criteria are issued as soon as possible and that CMS and ONC not make any changes that would require additional EHR functionality beyond those in the CMS and ONC criteria already released," the vendor wrote in its comments.

The timeline and complexity of the process pose barriers to adoption and innovation, CCHIT said in its public comments. "We believe the criteria and standards need refinement in order to drive an achievable step forward in the meaningful use of EHRs," said Mark Leavitt, MD, PhD, CCHIT chair, adding that the commission is "concerned about the possibility of an unintended deceleration in the pace of EHR adoption."

The American Health Information Management Association (AHIMA) also weighed in on the timeline. "AHIMA understands the urgency in establishing an enhanced national certification program. However, given the startup time and resources needed to launch a certification organization, the very tight time constraints this rule establishes could pose a challenge for entities who wish to become" authorized testing and certification bodies.

Starting to sense a theme here? How ONC will address these concerns is just one of many unanswered questions.