ONCHIT Proposes New Rules for Establishing Certification Programs to Health Information Technology

April 12, 2010

The Office of the National Coordinator of Health Information Technology with the Department of Health and Human Services (ONCHIT) has released a proposed rule for the establishment of certification programs for Electronic Health Record (EHR) technology.

The proposed rule sets forth the process by which the national coordinator can authorize organizations to become certification bodies that may test and certify complete EHRs and/or EHR modules. The proposed rule outlines a temporary and a permanent approach for establishing certification programs to test and certify EHRs. The temporary program would sunset once the permanent program is established and at least one certification body has been authorized by the national coordinator.

The temporary program would establish a process by which an organization would become an ONC-Authorized Testing and Certification Body (ONC-ATCB). Under the temporary program, the national coordinator would assume many of the responsibilities it has proposed to be fulfilled by the private sector under the permanent program. For the permanent program, ONCHIT is proposing a process by which an organization would become an ONC-Authorized Certification Body (ONC-ACB). Phase two will transition much of the responsibility for testing and certification to organizations in the private sector.

This proposed rule is the third rule that has been proposed or promulgated related to the Medicare and Medicaid EHR incentive program. The incentive program provides for payments to eligible professionals and eligible hospitals participating in Medicare and Medicaid that adopt and make “meaningful use” of certified EHR technology.

On Jan. 13, 2010, the Center for Medicare and Medicaid Services published in the Federal Register a notice of proposed rulemaking outlining the initial criteria an eligible provider or an eligible hospital must meet in order to qualify for incentive payments from Medicare and Medicaid for the adoption and meaningful use of certified EHR technology.

Also on Jan. 13, ONCHIT published an interim final rule setting forth the initial set of standards, implementation specifications, and certification criteria for EHR technology (the standards rule). This proposed rule signifies the establishment of programs for the voluntary certification of health information technology which is in compliance with the applicable certification criteria adopted by the secretary pursuant to the standards rule.

The temporary and permanent certification programs are set forth within the same proposed rule. However, the final rule for each will likely be published separately. Comments for the temporary program or the first phase for the certification program have already been accepted, and comments related to the permanent program are due May 10, 2010.