For the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, is an eligible professional or eligible hospital limited to demonstrating meaningful use in the exact way that EHR technology was tested and certified? For example, if a Complete EHR has been tested and certified using a specific workflow, is an eligible professional or eligible hospital required to use that specific workflow when it demonstrates meaningful use? Similarly, if the EHR technology was tested and certified with certain clinical decision support rules, are those the only clinical decision support rules an eligible health care provider is permitted to use when demonstrating meaningful use?
This FAQ has been jointly posted by ONC as FAQ24 and by CMS as FAQ 10473. In most cases, an eligible professional or eligible hospital is not limited to demonstrating meaningful use to the exact way in which the Complete EHR or EHR Module was tested and certified. As long as an eligible professional or eligible hospital uses the certified Complete EHR or certified EHR Module's capabilities and, where applicable, the associated standard(s) and implementation specifications that correlate with the respective meaningful use objective and measure, they can successfully demonstrate meaningful use even if their exact method differs from the way in which the Complete EHR or EHR Module was tested and certified.
It is important to remember the purpose of certification. Certification is intended to provide assurance that a Complete EHR or EHR Module will properly perform a capability or capabilities according to the adopted certification criterion or criteria to which it was tested and certified (and according to the applicable adopted standard(s) and implementation specifications, if any). The Temporary Certification Program and Permanent Certification Program Final Rules (75 FR 36188 and 76 FR 1301, respectively), published by the Office of the National Coordinator for Health IT (ONC), acknowledged that eligible professionals and eligible hospitals could, where appropriate, modify their certified Complete EHR or certified EHR Module to meet local health care delivery needs and to take full advantage of the capabilities that the certified Complete EHR or certified EHR Module includes.
These rules also cautioned that modifications made to a Complete EHR or EHR Module post-certification have the potential to adversely affect the technology's capabilities such that it no longer performs as it did when it was tested and certified, which could ultimately compromise an eligible professional or eligible hospital's ability to successfully demonstrate meaningful use.
In instances where a certification criterion expresses a capability which could potentially be added to or enhanced by an eligible professional or eligible hospital, the way in which EHR technology was tested and certified generally would not limit a provider's ability to modify the EHR technology in an effort to maximize the utility of that capability. Examples of this could include adding clinical decision support rules, adjusting or adding drug-drug notifications, or generating patient lists or patient reminders based on additional data elements beyond those that were initially required for certification. Modifications that adversely affect the EHR technology's capability to perform in accordance with the relevant certification criterion could, however, ultimately compromise an eligible professional or eligible hospital's ability to successfully demonstrate meaningful use.
In instances where the EHR technology was tested and certified using a sample workflow and/or generic forms/templates, an eligible professional or eligible hospital generally is not limited to using that sample workflow and/or those generic forms/templates. In this context, the "workflow" would constitute the specific steps, methods, processes, or tasks an eligible professional or eligible hospital would follow when using one or more capabilities of the certified Complete EHR or certified EHR Module to meet meaningful use objectives and associated measures. An eligible health care provider could use a different workflow and/or substitute different forms/templates for those that are included in the certified Compete EHR or certified EHR Module. Again, care should be taken to ensure that such actions do not adversely affect the Complete EHR's or EHR Module's performance of the capabilities for which it was tested and certified, which could ultimately compromise an eligible professional or eligible hospital's ability to successfully demonstrate meaningful use.