170.465—Revocation of authorized testing and certification body status.
(a) Type-1 violations.
The National Coordinator may revoke an ONC-ATCB's status for committing a Type-1 violation. Type-1 violations include violations of law or temporary certification program policies that threaten or significantly undermine the integrity of the temporary certification program. These violations include, but are not limited to: False, fraudulent, or abusive activities that affect the temporary certification program, a program administered by HHS or any program administered by the Federal government.
(b) Type-2 violations.
The National Coordinator may revoke an ONC-ATCB's status for failing to timely or adequately correct a Type-2 violation. Type-2 violations constitute noncompliance with § 170.460.
(1) Noncompliance notification.
If the National Coordinator obtains reliable evidence that an ONC-ATCB may no longer be in compliance with § 170.460, the National Coordinator will issue a noncompliance notification with reasons for the notification to the ONC-ATCB requesting that the ONC-ATCB respond to the alleged violation and correct the violation, if applicable.
(2) Opportunity to become compliant.
After receipt of a noncompliance notification, an ONC-ATCB is permitted up to 30 days to submit a written response and accompanying documentation that demonstrates that no violation occurred or that the alleged violation has been corrected.
(i)
If the ONC-ATCB submits a response, the National Coordinator is permitted up to 30 days from the time the response is received to evaluate the response and reach a decision. The National Coordinator may, if necessary, request additional information from the ONC-ATCB during this time period.
(ii)
If the National Coordinator determines that no violation occurred or that the violation has been sufficiently corrected, the National Coordinator will issue a memo to the ONC-ATCB confirming this determination.
(iii)
If the National Coordinator determines that the ONC-ATCB failed to demonstrate that no violation occurred or to correct the area(s) of non-compliance identified under paragraph (b)(1) of this section within 30 days of receipt of the noncompliance notification, then the National Coordinator may propose to revoke the ONC-ATCB's status.
(c) Proposed revocation.
(1)
The National Coordinator may propose to revoke an ONC-ATCB's status if the National Coordinator has reliable evidence that the ONC-ATCB committed a Type-1 violation; or
(2)
The National Coordinator may propose to revoke an ONC-ATCB's status if, after the ONC-ATCB has been notified of a Type-2 violation, the ONC-ATCB fails to:
(i)
To rebut the finding of a violation with sufficient evidence showing that the violation did not occur or that the violation has been corrected; or
(ii)
Submit to the National Coordinator a written response to the noncompliance notification within the specified timeframe under paragraph (b)(2).
(d) Suspension of an ONC-ATCB's operations.
(1)
The National Coordinator may suspend the operations of an ONC-ATCB under the temporary certification program based on reliable evidence indicating that:
(ii)
The continued testing and certification of Complete EHRs and/or EHR Modules by the ONC-ATCB could have an adverse impact on the health or safety of patients.
(2)
If the National Coordinator determines that the conditions of paragraph (d)(1) have been met, an ONC-ATCB will be issued a notice of proposed suspension.
(3)
Upon receipt of a notice of proposed suspension, an ONC-ATCB will be permitted up to 3 days to submit a written response to the National Coordinator explaining why its operations should not be suspended.
(4)
The National Coordinator is permitted up to 5 days from receipt of an ONC-ATCB's written response to a notice of proposed suspension to review the response and make a determination.
(5)
The National Coordinator may make one of the following determinations in response to the ONC-ATCB's written response or if the ONC-ATCB fails to submit a written response within the timeframe specified in paragraph (d)(3):
(iii)
Propose revocation in accordance with § 170.465(c) and suspend the ONC-ATCB's operations for the duration of the revocation process.
(e) Opportunity to respond to a proposed revocation notice.
(1)
An ONC-ATCB may respond to a proposed revocation notice, but must do so within 10 days of receiving the proposed revocation notice and include appropriate documentation explaining in writing why its status should not be revoked.
(2)
Upon receipt of an ONC-ATCB's response to a proposed revocation notice, the National Coordinator is permitted up to 30 days to review the information submitted by the ONC-ATCB and reach a decision.
(3)
Unless suspended, an ONC-ATCB will be permitted to continue its operations under the temporary certification program during the time period provided for the ONC-ATCB to respond to the proposed revocation notice and the National Coordinator to review the response.
(f) Good standing determination.
If the National Coordinator determines that an ONC-ATCB's status should not be revoked, the National Coordinator will notify the ONC-ATCB's authorized representative in writing of this determination.
(i)
A determination is made that revocation is appropriate after considering the information provided by the ONC-ATCB in response to the proposed revocation notice; or
(ii)
The ONC-ATCB does not respond to a proposed revocation notice within the specified timeframe in paragraph (d)(1) of this section.
(2)
A decision to revoke an ONC-ATCB's status is final and not subject to further review unless the National Coordinator chooses to reconsider the revocation.
(h) Extent and duration of revocation.
(1)
The revocation of an ONC-ATCB is effective as soon as the ONC-ATCB receives the revocation notice.
(2)
A testing and certification body that has had its ONC-ATCB status revoked is prohibited from accepting new requests for testing and certification and must cease its current testing and certification operations under the temporary certification program.
(3)
A testing and certification body that has had its ONC-ATCB status revoked for a Type-1 violation is prohibited from reapplying for ONC-ATCB status under the temporary certification program for one year. If the temporary certification program sunsets during this time, the testing and certification body is prohibited from applying for ONC-ACB status under the permanent certification program for the time that remains within the one year prohibition.
(4)
The failure of a testing and certification body that has had its ONC-ATCB status revoked, to promptly refund any and all fees for tests and/or certifications of Complete EHRs and EHR Modules not completed will be considered a violation of the Principles of Proper Conduct for ONC-ATCBs and will be taken into account by the National Coordinator if the testing and certification body reapplies for ONC-ATCB status under the temporary certification program or applies for ONC-ACB status under the permanent certification program.