CMS and ONC Release Final Rule Pertaining to Health IT Certification Criteria
October 15, 2015 09:57 AM
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) last week released several final rules pertaining to health information technology, including final rules for the Medicare and Medicaid Electronic Health Records (EHRs) Incentive Programs, and for the 2015 Edition Health Information Technology (Health IT) Certification Criteria (2015 Edition). While stages 2 and 3 of the Meaningful Use EHR Incentive program have no impact on home health due to the fact that home health agencies are ineligible for the incentive program, the National Association for Home Care & Hospice (NAHC) is reviewing the 2015 Edition of the Health IT Certification program as it contains modular EHR standards of interest to LTPAC providers, such as a transitions of care dataset.
The 2015 Edition of the Health IT Certification final rule updates the ONC Health IT Certification program to make it, according to ONC, “more open and accessible to other types of health IT and settings beyond those eligible for the EHR Incentive Programs, such as long-term and post-acute care (LTPAC), behavioral health, and pediatric settings.” The final rule attempts to support electronic health information across the continuum, through “improved access to technical standards that form an essential foundation for interoperability and help ensure that key data is consistently available to the right person, at the right place, and at the right time.”
The new rule contains several new and revised certification criteria “to support settings and use cases across the care continuum.” ONC encourages stakeholders to review all available criteria to determine which “best suit their needs.” Following are the new and revised criteria as announced and described by ONC:
Transitions of care – A new “transitions of care” (“ToC”) certification criterion will rigorously assess a product’s ability to create and receive interoperable Consolidated-Clinical Document Architecture (C-CDA) documents and exchange health information.
Common Clinical Data Set summary record – The final rule adopted two certification criteria focused on the ability of a Health IT Module to create (criterion) and receive (criterion) a summary care record formatted according to certain C-CDA 2.1 document templates and the Common Clinical Data Set, without testing or certifying to transport standards.
“Common MU Data Set” definition/name change – The final rule changed the Common MU Data Set name to the “Common Clinical Data Set.” This aligns with making the ONC Health IT Certification Program more open and accessible to other types of health IT beyond EHR technology and for health IT that supports care and practice settings beyond those included in the EHR Incentive Programs. Equally important, the Common Clinical Data Set includes new and updated standards and code sets for certification to the 2015 Edition to support more structured exchange of, and access to, electronic health information.
Care plan – This final rule has adopted a new 2015 Edition “care plan” certification criterion that would require a Health IT Module to enable a user to record, change, access, create, and receive care plan information in accordance with the Care Plan document template in the HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes.
Privacy and security – The 2015 Edition has adopted a new, streamlined approach to privacy and security certification requirements for Health IT Modules certified to the 2015 Edition.
Exchange of sensitive health information: Data Segmentation for Privacy (DS4P) – In consideration of stakeholder feedback and several of HHS’ overarching policy goals (enabling interoperability, supporting delivery system reform, reducing health disparities, and supporting privacy compliance), the 2015 Edition includes two new certification criteria that incorporate the DS4P standard:DS4P send – This criterion enables a user to create a summary record formatted in accordance with the DS4P standard that is document-level tagged as restricted and subject to restrictions on redisclosure; and DS4P receive – This criterion enables a user to receive a summary record that has been tagged with document-level tags using the DS4P standard. Additionally, a user will be allowed to sequester the document from other documents received and view the restricted document.
These standards are meant to align with the goals of the previously released Federal Health IT Strategic Plan (see previous NAHC Report article here). The Plan explains how the federal government intends to apply the effective use of information and technology to help the nation achieve high-quality care, lower costs, a healthy population, and engaged individuals.
NAHC is reviewing the rule to determine whether comments are warranted. Click here to see ONC’s fact sheet, and here to see ONC’s press release on the new rules. In addition, more federal resources are available here. Please feel free to email NAHC staff at email@example.com with any comments you may have on the final rule.