View all text of Subpart C [§ 10.20 - § 10.24]

§ 10.20 - Administrative Dispute Resolution Panel.

The Secretary shall establish a 340B Administrative Dispute Resolution Board (Board) consisting of at least six members appointed by the Secretary with equal numbers from the Health Resources and Service Administration (HRSA), the Centers for Medicare & Medicaid Services (CMS), and the Office of the General Counsel (OGC) from which Administrative Dispute Resolution Panels (340B ADR Panel) of three members shall be selected by the HRSA Administrator (to review claims and, pursuant to authority expressly delegated through this rule by the Secretary, and to make precedential and binding final agency decisions regarding claims filed by covered entities and manufacturers). There shall also be one ex-officio, non-voting member chosen from the staff of the HRSA Office of Pharmacy Affairs (OPA). HRSA and CMS Board members shall have relevant expertise and experience in drug pricing or drug distribution. OGC Board members shall have expertise and experience in handling complex litigation.

(a) Members of the 340B ADR Panel. (1) For each case, the HRSA Administrator shall:

(i) Select from the Board three voting members, one from each of the three HHS operating or staff divisions involved (i.e., CMS, HRSA, OGC) to form a 340B ADR Panel.

(ii) Remove an individual from a 340B ADR Panel for cause; and

(iii) Appoint replacement members from the Board should an individual be unable to complete his or her duties on a 340B ADR Panel.

(2) No member of a 340B ADR Panel may have a conflict of interest, as defined in paragraph (b) of this section.

(b) Conflicts of interest. All individuals who serve on a 340B ADR Panel will be screened for conflicts of interest prior to reviewing a claim. Conflicts of interest may include:

(1) Financial interest in a party involved, a subsidiary of a party involved, or in the claim before a 340B ADR Panel;

(2) Family or close relation to a party involved; and

(3) Current or former business or employment relation to a party.

(c) Duties of the 340B ADR Panel. The 340B ADR Panel will adjudicate each claim using the procedures described §§ 10.21, 10.22, 10.23, and 10.24.

(1) Review and evaluate documents and other information submitted by covered entities and manufacturers;

(2) Request additional information or clarification of an issue from any or all parties to make a final agency decision;

(3) When necessary, evaluate a claim in a separate session from the parties involved;

(4) Consult with OPA and the parties, as appropriate and necessary, regarding any inquiries or concerns while reviewing a claim; and

(5) Issue a final agency decision on each claim and submit the written decision to the parties, and to HRSA for appropriate action.