§ 10.23 - 340B ADR Panel decision process.

§ 10.23 Conduct of the ADR proceeding.

(a)

340B ADR Panel decision process.

(a) The 340B ADR Panel will conduct a review of the claims. The 340B ADR Panel will review all documents gathered during the 340B ADR process to determine if a violation as described in § 10.21(a)(1) or (2) has occurred.

(b) The 340B ADR Panel will

determine, in its own discretion, the most efficient and practical form of the ADR proceeding. Unless the matter is resolved through a motion to dismiss or summary judgment under Rule 56, the 340B ADR Panel shall conduct an evidentiary hearing when there are material facts in dispute. The ADR proceeding may be conducted by video conference, in-person, or through other means.

(b) The 340B ADR Panel will determine the proper course of conduct in an ADR proceeding. Unless the parties agree otherwise and the 340B ADR Panel concurs, the Federal Rules of Civil Procedure, to the extent applicable, shall govern the proceedings.

(c) Unless the parties agree otherwise and the 340B ADR Panel concurs, the Federal Rules of Evidence shall apply to the proceedings.

(d) The 340B ADR Panel may issue additional instructions or guidance as may be necessary or desirable governing the conduct of ADR proceedings

prepare a decision letter based on its review. The 340B ADR Panel's decision letter will be completed within one year of receiving a complete claim for review, except to the extent that there are situations beyond the control of the 340B ADR Panel that may affect the ability to issue a decision on a claim within one year. If the issuance of a 340B ADR Panel decision will exceed one year, the 340B ADR Panel must provide notice to the parties involved. The 340B ADR Panel decision letter will represent the determination of a majority of the 340B ADR Panel members' findings regarding the claim and include an explanation regarding each finding. The 340B ADR Panel will transmit its decision letter to all parties and to the OPA Director.

(c) The 340B ADR Panel decision letter will inform the parties involved of their rights for reconsideration as described in § 10.24. Either party may request reconsideration of the 340B ADR Panel decision or the Health Resources and Service Administration (HRSA) Administrator may decide to initiate a reconsideration without such a request. The final agency decision will be binding upon the parties involved in the dispute unless invalidated by an order of a Federal court. The 340B ADR Panel's decision letter will be effective 30 business days from issuance and serve as the final agency decision unless:

(1) Within 30 business days of issuance, reconsideration occurs under § 10.24; or

(2) Within 30 business days of issuance, the Secretary makes a determination that the Secretary will review the decision.

(d) The OPA Director will determine any necessary corrective action or consider whether to take enforcement action, and the form of any such action, based on the final agency decision.