Of the three tenets of meaningful use -- adopt certified electronic health record technology, demonstrate core and menu set requirements, and report on clinical quality measures -- adopting certified EHRs has proven more complicated than most providers anticipated. In an iHealthBeat Perspective last year, we discussed some of the specific challenges that health care providers -- in this context, both eligible hospitals and eligible professionals -- have faced in adopting certified technology. One of the most significant challenges was the Office of the National Coordinator for Health IT's December 2010 clarification that required providers to possess each of the certified EHR's capabilities, not just those that they intended to use to demonstrate meaningful use.
Fortunately, ONC's recently released proposed rule lays out a different approach to certification, called the 2014 Edition. ONC breaks the concept of the complete EHR into base, core and menu capabilities. The base constitutes a fundamental set of capabilities, which all providers demonstrating meaningful use must possess. It includes some obvious components, like the ability to capture vital sign and demographic data, in addition to some newer components that underscore CMS' and ONC's increased focus on patient engagement and interoperability (like the ability to support transitions of care and patients' ability to view, download and transmit their health information). Beyond the base, providers must acquire capabilities relevant to the stage that they are in and the menu set items they have selected, defined by the core and menu in the 2014 Edition, but not more.
This revision is a step in the right direction, but we believe it may not be sufficient. Providers were and continue to be bound by two additional, interrelated issues:
- ONC has not relaxed its stipulation that a certified bundle cannot be separated into discrete, certified components; and
- Commercial vendors were inclined to certify their products as complete EHRs, rather than in modules.
Even if ONC no longer requires providers to maintain all aspects of a certified EHR, then these two interrelated forces will likely create a similar effect. Vendors will continue to certify complete EHRs. Providers, in turn, will need to ensure that they maintain licenses to access and use all of the components of these systems, as certified, to maintain certified status.
ONC has outlined alternatives to complete EHR certification, which include modular and self certification. These have not proved to provide sufficient flexibility for the following reasons:
Modular Certification: In Stage 1, commercial vendors did pursue a limited number of modular certifications, but not enough to reflect the complex reality of how today's hospitals use these products in their environments. In part, this was due to vendors' legitimate concern regarding how narrowly they could break apart a bundle of products and continue to ensure interoperability and maintain required standards. In our experience, providers typically selected the complete or modularly certified products that best represented their environment. In tandem, they commonly obtained a license to access and use capabilities that they did not intend to implement so as to maintain each bundle's certified status.
Self Certification: Self certification of a unique bundle of products was an option, but few providers took advantage of it. In part, this was because providers were assembling bundles of commercial products, which they did not have the expertise to take through the certification process independently. The more significant factor was that demonstrating the core and menu set measures required a significant investment of time and resources. Taking on self certification would have significantly increased the investment providers were making to achieve meaningful use, not only for the current stage but into the future, as new editions of certified EHR technology are required.
As a result, providers' decisions regarding the bundle of products they acquire will continue to be dictated not only by the bundle of products that ONC requires providers to have, but by the bundle of products that their vendors certify.
To create true flexibility, ONC must relax its stipulation that separated components of a certified bundle do not inherit certification. ONC should revise its certification program such that a certified complete or modular EHR can be separated into individually certified modules for any capabilities outside of base requirements. This would in no way require vendors to ensure that each independently certified module could be separated in actuality. Functionalities are necessarily tied in many instances. This modification would ensure that providers have the option to separate capabilities where it is possible. Further, documentation at the criterion level will ensure that providers know what functionality they must implement to use a product as certified. This clarity regarding what capabilities were certified to support specific criterion is particularly important in the event a provider chooses not to implement the full bundle as certified.
There are three primary benefits to this modification:
Reduction of Waste: Many providers acquired redundant, certified capabilities owing to the fact that they could not separate certified bundles. Eliminating this redundancy would reduce waste (in the instance that providers truly acquired two functionalities) and administrative burden (in the instance that providers simply acquired a license to access and use a redundant capability at no cost).
More Flexibility in Product Selection: This additional flexibility would allow providers to choose the array of certified products that best represents their strategic aims. By not allowing providers to separate certified products, ONC created stickiness in the market that raised the opportunity cost of working with additional vendors, outside of the provider's core vendor.
Greater Quality Control: Providers were never required to fully implement all components of a bundle, only to possess a license to access and use all of its capabilities, as certified. As such, providers ran the risk of negatively impacting performance by implementing aspects of a certified bundle and not others. For example, if a vendor built CPOE and medication reconciliation functionality together, then a provider's decision not to implement the medication reconciliation functionality could significantly impact CPOE's usability and create patient safety issues.
This modification would pose a significant change to the certification process in that certification bodies would need to create documentation at the individual criterion level for all capabilities outside of the base set. ONC also would need to reconceive its Certified Health IT Product list, as the certified bundle would matter less than the individually certified modules.
Finally, while providers would realize greater flexibility, they also would realize greater risk in that they would take on responsibility for making sure that EHR modules worked together in a best-of-breed environment. We believe that despite this risk, ONC intended to allow this flexibility through its modular certification process, as described in the Permanent Certification Rule, given that many providers use best-of-breed environments today.
While ONC should closely weigh these considerations, we believe the benefits -- reduced waste, more flexibility and greater quality control -- outweigh the costs.
The Advisory Board Company's Robin Raiford and Protima Advani contributed to this article.