ONC Open Casting Calls
Prepared by Krystyna Nowik, Esq.
Last week, ONC opened a thirty-day window for organizations to apply to become the sole accrediting entity to oversee certifying organizations under the Permanent Certification Program for Health Information Technology (“Certification Program”). The Certification Program ensures certain electronic health record (“EHR”) technology includes required capabilities for participation in the Medicare and Medicaid EHR Incentive Programs, which provide incentive payments to certain eligible health care professionals, hospitals and critical access hospitals that demonstrate meaningful use of certified EHR technology to adopt and utilize EHRs (“Meaningful Use”).
Currently, EHR vendors must be tested and certified by one of six ONC-approved entities (ONC-Authorized Testing and Certification Body or ONC-ATCB) under a temporary certification program implemented to ensure certified EHR technology was available for incentive payments beginning this year. Vendors who seek ONC-ATCB certification of their EHR technology as either a “Complete EHR” or an “EHR Module” must demonstrate compliance with certain capabilities, standards, implementation specifications and certification criteria. Once EHR technology has been ONC-ATCB certified, it can be used by health providers and hospitals to meet applicable meaningful use requirements. Complete EHRs provide all applicable certification criteria and the minimum capabilities a participant needs to comply with Meaningful Use. They may also include additional functions. EHR Modules, on the other hand, meet at least one, but not all, of the required certification criteria, and a combination of EHR Modules may be used to comply with Meaningful Use.
With the Final Rule for the Certification Program issued this January, accreditation and oversight is placed in the hands of the ONC Approved Accreditor or ONC-AA, which will be selected competitively every three years. The ONC-AA will be responsible for overseeing the ONC-ATCB entities and accrediting the Authorized Certified Bodies (ONC-ACB) under the Certification Program. Competing organizations for the ONC-AA will have to show what their proposed requirements would be for accrediting the ONC-ACBs, how surveillance of certified EHR technology would be conducted, their requirements for key personnel conducting the accreditation, and investigation and responding to complaints about ONC-ACBs. They also must show how they would adhere to ISO/IEC17011:2004 and experience with ISO/IEC Guide 65:1996, standards developed by the International Standardization Organization that specify general requirements for approving conformity assessment organizations and for product certifying organizations.
The ONC-ACBs replace the ONC-ATCBs created by the temporary certification program. Although ONC-ATCB status ends upon the sunset of the temporary certification program, certifications issued by ONC-ATCBs through the 2011/2012 payment years do not need to be re-certified for those years until ONC-ACB certification processes are in place.
The Notice for submission of requests for ONC-AA status may be found here.
