On February 21 2014 the HHS Office of the National Coordinator for Health Information Technology (ONC) issued proposals for the next edition (the “2015 Edition”) of electronic health record (EHR) technology certification criteria.
This proposed rule marks the first time ONC has proposed an edition of certification criteria separate from the Centers for Medicare & Medicaid Services’ “meaningful use” regulations. The proposals represent ONC’s new regulatory approach that includes more incremental and frequent rulemaking. This approach allows ONC to update certification criteria more often to reference improved standards, continually improve regulatory clarity, and solicit comments on potential proposals as a way to signal ONC’s interest in a particular topic area.
“The proposed 2015 Edition EHR certification criteria reflect ONC’s commitment to incrementally improving interoperability and efficiently responding to stakeholder feedback,” said Karen DeSalvo, M.D., M.P.H., national coordinator for health IT. “We will continue to focus on setting policy and adopting standards that make it possible for health care providers to safely and securely exchange electronic health information and for patients to become an integral part of their care team.”
Compliance with the 2015 Edition would be voluntary – EHR developers that have certified EHR technology to the 2014 Edition would not need to recertify to the 2015 Edition for customers to participate in the Medicare and Medicaid EHR Incentive Programs. Similarly, health care providers eligible to participate in the Medicare and Medicaid EHR Incentive Programs would not need to “upgrade” to EHR technology certified to 2015 Edition to have EHR technology that meets the Certified EHR Technology definition. “This provides the opportunity for developers and health care providers to move to the 2015 Edition on their own terms and at their own pace,” said Dr. DeSalvo.
Key Highlights of 2015 Edition
The proposed rule introduces new capabilities, standards-based requirements and public comment solicitations on potential future certification criteria. Key proposals are:
- New certification criteria to support patient population filtering of clinical quality measures
- New and updated implementation specification for several certification criteria including Transition of Care (ToC), Clinical Decision Support (CDS), and Public Health reporting
- Policy revisions that changes certification approach for ToC
- Path for certification of ‘non-Meaningful Use (MU)’ EHR technology
- Codifies ONC regulatory guidance provided in FAQ issued in 2014 Edition Final Rule
- Revision to 2014 Edition syndromic surveillance certification criterion
- Closer alignment with other HHS program policies(e.g. CLIA) and to address Office of Inspector General (OIG) recommendations
- Discontinuation of ‘Complete EHR’ definition and issuance
- Solicit comment on new capabilities and standards-based requirements for potential future certification criteria
Why the 2015 Edition is important for Longitudinal Coordination of Care (LCC)
Over the last three years, the ONC Standards & Interoperability (S&I) Longitudinal Coordination of Care (LCC) Workgroup has identified functional and technical specifications to enable the interoperable exchange of transition of care documents and care plans (to include the Home Health Plan of Care) across multiple settings and disciplines. Since conception, the LCC WG has advocated for the availability and adoption of standards to support and inform patient-centric care delivery without regard to setting and whether these sites receive MU incentive payments.
The LCC WG technical specifications informed the most recent updates to the consolidated clinical document architecture (C-CDA), the single document standard permitted for certification and the representation of summary care records required for Meaningful Use Stage 2. These revisions to the C-CDA will be published as a new standard by May 2014.
The 2015 Edition proposes the adoption of the updated C-CDA standard for certification and representation of summary care records to include:
- New document templates: Care Plan; Referral Note; Transfer Summary
- New sections for: Goals; Health Concerns; Health Status Evaluation/Outcomes; Mental Status; Nutrition; Physical Findings of Skin
- New organizers and many new entries (e.g. Wound Observation, Patient and Care Team Priorities)
The new standard is proposed to be referenced for several certification criteria: ToC, VDT and Data Portability. For the ToC and VDT criterion, the rule also proposes EHR technology developers separately test and certify ‘content’ capabilities (i.e. CCDA) and ‘transport’ capabilities (i.e. Direct Project Specification).
Next Steps
The publication of the revisions to the C-CDA and their subsequent inclusion in the 2015 Edition is a critical step in ensuring the availability and adoption of standards to alleviate fragmented, unsafe duplicative and costly care for those patient populations that need it most. As an LCC Community, you have the opportunity to submit your comments to the proposed rule by any of the following methods:
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Federal eRulemaking Portal: Follow the instructions for submitting comments. Attachments should be in Microsoft Word, Microsoft Excel, or Adobe PDF; however, Microsoft Word is preferred. http://www.regulations.gov.
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Regular, Express, or Overnight Mail: Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Attention: 2015 Edition EHR Standards and Certification Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington, DC 20201. Please submit one original and two copies.
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Hand Delivery or Courier: Office of the National Coordinator for Health Information Technology, Attention: 2015 Edition EHR Standards and Certification Criteria Proposed Rule, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave. SW., Washington, DC 20201.
Please submit one original and two copies. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.)
Comments are due April 28, 2014 at 11:59 P.M. (EST).
Final rule to be published by Summer 2014.