On March 2, 2012, the Office of the National Coordinator for Health Information Technology (ONC) published a companion rule to the Centers for Medicare & Medicaid Services (CMS) Stage 2 meaningful use (MU) proposed rule, concerning certification criteria that electronic health record (EHR) technology must satisfy in order to support the achievement of Stage 2 MU. The CMS Stage 2 MU proposed rule outlines the criteria for eligible professionals (EPs) and eligible hospitals (EHs) and Critical Access Hospitals (CAHs) to become meaningful users in the Stage 2 incentive program. Commenters recommending changes to the proposed Stage 2 MU objectives would also need to consider if changes would be needed to the ONC EHR Certification proposed rule.
Proposal in Brief
ONC proposes that effective 2014, EHR technology must be certified against the criteria to be used in the program. Most importantly, the proposed rule would change the definition of a qualified EHR to allow providers more flexibility in the scope of the systems they use. In order to have EHR technology that meets the definition of Certified Electronic Health Record Technology (CEHRT) in FY/CY 2014, EPs, EHs and CAHs would be required to have a base EHR and additional EHR technology necessary to meet the MU objectives and measures for the specific stage of MU they seek to meet and to capture, calculate and report clinical quality measures.
Another emphasis of the rule is privacy and security. Privacy and security capabilities are included in the base EHR that must be part of every EP's, EH's and CAH's CEHRT. To increase clarity, ONC provides methods for clearly representing certified complete EHRs and certified EHR modules. In addition, ONC proposes that test results used for the certification of the technology be available to the public.
Applicability and Scope of Certification
ONC proposes to add that complete EHRs and EHR modules are not required to be certified to specific capabilities within a certification criterion designated as optional. In addition, the rule also would clarify if certification criteria within a certification are applicable to both ambulatory and inpatient settings, or if they apply to only one or the other setting.
New Certification Criteria
In the ambulatory and in-patient setting, ONC proposed to adopt certification criteria that would be new and applicable to both settings. These criteria include: (1) electronic notes, including the ability to search the notes; (2) imaging, including the ability to access the images and narrative interpretations directly, without having to log in to a separate system; (3) the capability to record, change and access the health history of a patient's first-degree relatives; (4) the ability to view, download and transmit to a third party (or to the patient's personal health record); (5) the express ability to track and identify the use and who uses this function (patient accessible log); and (6) safety-enhanced design (the extent to which a product can be used by specified users to meet specified goals with effectiveness, efficiency and satisfaction in a specific context).
In this context, ONC also proposes using ICD-10 codes even though HHS has delayed implementation of ICD-10.
In the ambulatory setting ONC proposes adopting three new certification criteria related to secure messaging, data capture of cancer case information and transmission to cancer registries. For in-patient settings, ONC proposes to adopt three certification criteria related to standards for tracking medications, electronic prescribing and transmission of electronic laboratory tests.
ONC is also considering including in the final rule an additional certification criterion that would require an EHR technology developer to document how its EHR technology development process either aligns with or deviates from the quality management principles and process included in the rule.
A certification criterion for clinical decision support on high-priority health conditions is also revised, and in addition, certification will now need to include patient education resources.
Transitions of Care
Because Stage 2 MU will include providing a care summary as patients transition to another care setting or to another provider of care, ONC proposes adopting two criteria to provide developers greater flexibility. The first would require EHR technology to be able to incorporate a summary care record according to the consolidated CDA, and the second would require that the technology be capable of generating and transmitting a summary care record in accordance with the consolidated CDA, with certain specified vocabulary standards and transport standards.
Data Capture
Prior to the EHR incentive programs, EHRs did not routinely capture data for clinical quality measures (CQMs). The first specific capability proposed for CQM certification focuses on the capability of EHR technology to electronically record all the data elements that are represented in the quality data management (QDM) tools. Technology would need to be able to record data in some representation that can be associated with the categories, states and attributes of the QDM. ONC recognizes that there is a gap between the data defined by QDM and the data traditionally captured in EHR technology. ONC specifically requests comments on how long the industry believes it would take to close the gap.
Minimum Code Sets
Because new versions of the minimum standards code sets are adopted more frequently, ONC seeks to find ways to permit technology to be upgraded and certified to newer versions of these codes. ONC proposes that unless the secretary prohibits the use of a newer version, the newer version could be used voluntarily for certification and implementation as an upgrade.
Privacy and Security Certification
Modules would be certified to all privacy and security certification criteria unless presented for certification as pre-coordinated integrated bundle of EHR modules or if EHR modules are presented for certification and provide documentation that privacy and security certification criteria are inapplicable.
ONC is providing a 60-day period, which ends on May 7, 2012, to allow the public to comment on the proposed rule.
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