ONC Releases Final Certification Rule
By Claire Cowart Haltom
January 18, 2011 | New details of the health information technology (HIT) permanent certification program have been released, and it appears that the federal government will be leaning heavily on the private sector to oversee the electronic health records (EHR) certification process.
On January 3, the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish the permanent certification program for health information technology. The final rule includes new guidelines to improve the transparency, comprehensiveness, reliability, and efficiency of the EHR program.
Hospitals and health care providers seeking to qualify for incentive payments under the Medicare and Medicaid EHR incentive programs must show meaningful use of certified electronic health-record technology. As a result, the certification procedure is a critical piece of the EHR incentive programs.
Last summer, the ONC established a temporary EHR certification program which will be in effect until December 31, 2011. The January 3 final rule provides EHR vendors and users with details about the permanent EHR certification program that will begin January 1, 2012.
The procedure set forth by the ONC in the final rule essentially establishes the outsourcing of the EHR certification process. Answering calls for an independent accreditation body to help provide an open and transparent process, the ONC will use a competitive process in the permanent program to appoint one private-sector accreditation organization as the "ONC-Approved Accreditor" (ONC-AA). The ONC-AA will serve as the sole accreditation body for a period of three years. At the end of the three year term, the ONC-AA will be required to compete with new applicants for the ONC-AA role.
The ONC noted that the use of a single private-sector accreditation organization is the optimal and most practical approach for the long term because specialized accreditors in the private sector are better equipped to react effectively and efficiently to changes in the HIT market than the federal government and to rigorously oversee the certification bodies they accredit. The ONC also noted that it expects the impartiality, knowledge, and experience of an independent accreditor to instill additional confidence in HIT developers, eligible professionals and eligible hospitals, and the general public regarding the certification process.
The ONC-AA's primary responsibility will be to approve an estimated six Authorized Certification Bodies (ONC-ACBs) who will perform the actual testing and certifying of health information technology. All organizations wishing to certify EHR systems will have to apply for ONC-ACB status and the ONC-ACBs will be required to renew their status every three years.
The certification bodies previously authorized under the temporary certification program, the ONC-Authorized Testing and Certification Bodies (ONC-ATCBs), will not automatically become ONC-ACBs. The ONC-ACBs will be required to go through the same accreditation process with the ONC-AA in order to be eligible for the new ONC-ACB status.
Because the ONC-ACBs will be tasked with the responsibility to ensure that the certifications they issue serve as an indication of an EHR system's capabilities and compliance, the permanent program requires ONC-ACBs to follow-up on previously issued certifications. ONC-ACBs will have to conduct post-certification surveillance activities to ensure that the EHR performs as intended once it is set up in an operational environment.
In a move that hopefully will put developers' and vendors' minds at ease, the ONC clarified that each updated version of an EHR would not need to be recertified in order for its certification to remain valid. According to the final rule, a previously certified EHR system may be updated for routine maintenance or to include new or modified capabilities without the need for recertification.
Finally, the ONC sought to address the gap that may occur between certifications due to future ONC requirement criteria. For instance, it is expected that many EHR systems would be certified under the Stage 1 meaningful use regulations before the Stage 2 meaningful use regulations are available, thus creating a gap in certification. Under the final rule, ONC-ACBs are permitted to perform "gap certifications," evaluations of the EHR system for only those new criteria that are required, rather than mandating that the EHR system undergo the full EHR system certification again. The HIT market should consider an EHR system that has been "gap certified" to be equal to EHR system that has been fully tested and certified to all applicable certification criteria.
Both the ONC–AA and the ONC–ACBs have significant responsibilities under the permanent certification program that are intimately linked to the success of the certification and EHR incentives programs. The final rule issued by ONC on the permanent certification program helps to clarify many questions and improve the transparency and efficiency of the EHR certification program. These provisions should help EHR vendors and users confidently move forward with EHR implementation.
The text of the final rule is available here: http://origin.www.gpo.gov/fdsys/pkg/FR-2011-01-07/pdf/2010-33174.pdf
Claire Cowart Haltom is a health care attorney at Baker Donelson. She can be reached at chaltom@bakerdonelson.com.