This subpart establishes, as to QHINs, the application, review, Onboarding, withdrawal, and redetermination processes for Designation.

An entity seeking to be Designated as a QHIN must submit all of the following information in a manner specified by ASTP/ONC:

(a) Completed QHIN application, with supporting documentation, in a form specified by ASTP/ONC; and

(b) A signed copy of the Common Agreement.

(a) ASTP/ONC (or an RCE) will review a QHIN application to determine if the Applicant QHIN has completed all parts of the application and provided the necessary supporting documentation. If the QHIN application is not complete, the applicant will be notified in writing of the missing information within thirty (30) calendar days of receipt of the application. This timeframe may be extended by providing written notice to the Applicant QHIN.

(b) Once the QHIN application is complete, ASTP/ONC (or an RCE) will review the application to determine whether the Applicant QHIN satisfies the requirements for Designation set forth in § 172.201 and, if the Applicant QHIN proposes to provide IAS, the requirements set forth in § 172.202. ASTP/ONC (or an RCE) will complete its review within sixty (60) calendar days of the Applicant QHIN being provided with written notice that its application is complete. This timeframe may be extended by providing written notice to the Applicant QHIN.

(c) Additional information may be requested from the Applicant QHIN while ASTP/ONC (or an RCE) is reviewing the application. The timeframe for responding to the request and the manner to submit additional information will be provided to the applicant and may be extended on written notice to the Applicant QHIN.

(d) Failure to respond to a request within the proposed timeframe or in the manner specified is a basis for a QHIN Application to be deemed withdrawn, as set forth in § 172.305(c). In such situations, the Applicant QHIN will be provided with written notice that the application has been deemed withdrawn.

(e) If, following submission of the application, any information submitted by the Applicant QHIN becomes untrue or materially changes, the Applicant QHIN must notify ASTP/ONC (or an RCE) in the manner specified by ASTP/ONC (or an RCE) of such changes in writing within five (5) business days of the submitted material becoming untrue or materially changing.

(a) An Applicant QHIN has the burden of demonstrating its compliance with all qualifications for Designation in § 172.201 and, if the Applicant QHIN proposes to provide IAS, the qualifications in § 172.202.

(b) If ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) determines that an Applicant QHIN meets the requirements for Designation set forth in § 172.201, and if the Applicant QHIN proposes to provide IAS, the qualifications set forth in § 172.202, then ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) will notify the applicant in writing that its application has been approved, and the Applicant QHIN may proceed with Onboarding.

(c) An approved Applicant QHIN must submit a signed version of the Common Agreement within a timeframe set by ASTP/ONC (or an RCE).

(d) An approved Applicant QHIN must complete the Onboarding process, including any tests required to ensure the Applicant QHIN's network can connect to those of other QHINs and other Applicant QHINs, within twelve (12) months of approval of its QHIN application, unless that timeframe is extended in ASTP/ONC's (or an RCE's) sole discretion by up to twelve (12) months.

(a) If all requirements of the Onboarding process specified in § 172.303 have been satisfied:

(1) The Common Agreement will be countersigned; and

(2) The Applicant QHIN will be provided with a written determination indicating that the applicant has been Designated as a QHIN, along with a copy of the countersigned Common Agreement.

(b) Within thirty (30) calendar days of receiving its Designation, each QHIN must demonstrate in a manner specified by ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) that it has completed a successful transaction with all other in-production QHINs according to standards and procedures for TEFCA Exchange.

(c) If a QHIN is unable to complete the requirement in paragraph (b) of this section within the thirty (30)-day period provided, the QHIN must provide ASTP/ONC (or an RCE) with a written explanation of why the QHIN has been unable to complete a successful transaction with all other in-production QHINs within the allotted time and include a detailed plan and timeline for completion of a successful transaction with all other in-production QHINs. ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) will review and either approve or reject the QHIN's plan based on the reasonableness of the explanation and the specific facts and circumstances, within five (5) business days of receipt. If the QHIN fails to provide its plan or the plan is rejected, ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) will rescind its approval of the application, rescind the QHIN Designation, and deny the application. Within thirty (30) calendar days of end of the term of the plan, each QHIN must demonstrate in a manner specified by ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) that it has completed a successful transaction with all other in-production QHINs according to standards and procedures for TEFCA Exchange.

(d) A QHIN Designation will become final sixty (60) days after a Designated QHIN has submitted its documentation that it has completed a successful transaction with all other in-production QHINs.

(a) An Applicant QHIN may voluntarily withdraw its QHIN application by providing written notice in a manner specified by ASTP/ONC (or an RCE).

(b) An Applicant QHIN may withdraw its QHIN application at any point prior to Designation.

(c) Upon written notice to the Applicant QHIN, a QHIN application may be deemed withdrawn by ASTP/ONC (or, with ASTP/ONC's prior authorization, an RCE) as a result of the Applicant QHIN's failure to respond to requests for information from ASTP/ONC (or an RCE).

If an Applicant QHIN's application is denied, the Applicant QHIN will be provided with written notice that includes the basis for the denial.

(a) Subject to paragraphs (b) through (d) of this section, applications may be resubmitted by Applicant QHINs by complying with the provisions of § 172.301 in the event that an application is denied or withdrawn.

(b) The Applicant QHIN may reapply at any time after it has voluntarily withdrawn its application as specified in § 172.305(a).

(c) If ASTP/ONC (or an RCE) deems a QHIN application to be withdrawn as a result of the Applicant QHIN's failure to respond to requests for information, then the Applicant QHIN may reapply by submitting a new QHIN application no sooner than six (6) months after the date on which its previous application was submitted. The Applicant QHIN must respond to the prior request for information and must include an explanation as to why no response was previously provided within the required timeframe.

(d) If ASTP/ONC (or an RCE) denies a QHIN application, the Applicant QHIN may reapply by submitting a new application consistent with the requirements in § 172.301 no sooner than six (6) months after the date shown on the written notice of denial. The application must specifically address the deficiencies that constituted the basis for denying the Applicant QHIN's previous application.