The U.S. Department of Health & Human Services (HHS) has issued a final rule outlining the steps that the Office of the National Coordinator for Health IT (ONC) would take to handle improper conduct or poor performance of the ONC approved accreditor (ONC-AA) under the permanent certification program for the demonstration of Meaningful Use.
The final rule, published in the Federal Register Nov. 25, enables ONC to remove the ONC-AA for conduct violations such as fraud, falsifying accreditations, or embezzlement. It also authorizes removal for performance violations that are not timely or adequately corrected, such as maintaining conformance with ISO 17011, verifying conformance to Guide 65 in ONC authorized certification bodies (ONC-ACBs), and verifying that ONC-ACBs are performing required surveillance of the electronic health record systems they have certified as meeting Meaningful Use criteria.
The ONC-AA approves the organizations selected to be ONC-ACBs. ONC announced in June that the American National Standards Institute (ANSI) shall serve as the first ONC-AA under the permanent certification program. Only one ONC-AA is appointed at a time.
HHS noted in the final rule that, should the ONC-AA engage in conduct or performance violations, ONC would act to remove the ONC-AA rather than suspend the organization. Such action would be taken on the grounds that "a removal process would protect the integrity of the permanent certification program and maintain public confidence in the program by removing an ONC-AA that engages in misconduct or fails to satisfy its performance obligations under the program."
ONC-ACBs would remain in place after removal of the ONC-AA for a reasonable time until accredited by the new ONC-AA.
The final rule becomes effective on Dec. 27. The permanent certification program was to have gone into effect Jan. 1, 2012, but per notice earlier this month, was delayed until mid-2012.