[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Page 33317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Appointment of Administrative Dispute Resolution Board Members

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: On December 14, 2020, the Department of Health and Human 
Services published in the Federal Register a final rule (``Rule'') 
establishing the 340B Drug Pricing Program (340B Program) 
Administrative Dispute Resolution (ADR) Board (hereafter, ``the 
Board''). See 85 FR 80632 (Dec. 14, 2020). According to the Rule, the 
purpose of the 340B Program's ADR process is to resolve (1) claims by 
covered entities that they have been overcharged for covered outpatient 
drugs by manufacturers and (2) claims by manufacturers, after a 
manufacturer has conducted an audit as authorized by section 
340B(a)(5)(C) of the Public Health Service Act, that a covered entity 
has violated the prohibitions on diversion or duplicate discounts. The 
Rule states that Board members from the Centers for Medicare & Medicaid 
Services (CMS) and the Health Resources and Services Administration 
(HRSA) must have relevant expertise and experience in drug pricing or 
drug distribution. The Rule also states that Board members from the 
Office of the General Counsel (OGC) must have expertise and experience 
in handling complex litigation. From the 340B ADR Board, the HRSA 
Administrator will select three voting members, one from each of the 
three HHS operating/staff divisions involved (i.e., CMS, HRSA, OGC) to 
form 340B ADR Panels that will review claims and, pursuant to delegated 
authority from the Secretary, make certain final agency decisions.
    All previous appointments to the Board are revoked. Based on 
recommendations from OGC, CMS, and HRSA, I hereby appoint the following 
Board members, who shall serve a term of two years, to be extended for 
additional terms upon agreement by the member and the head of his or 
her operating/staff division.
    Sean R. Keveney, Deputy General Counsel, the Office of the General 
Counsel, Department of Health and Human Services;
    Andy J. Miller, National Complex Litigation and Investigations 
Division Attorney, the Office of the General Counsel, Department of 
Health and Human Services;
    Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, Health 
Resources and Services Administration, Department of Health and Human 
Services;
    CAPT Christina Meade, Area Regional Pharmacy Consultant, Office of 
Regional Operations, Health Resources and Services Administration, 
Department of Health and Human Services;
    CDR Timothy Lape, Division of Medicare Health Plans Operations, 
Medicare Branch, Centers for Medicare & Medicaid Services, Department 
of Health and Human Services;
    Adele Pietrantoni, Office of Program Operations and Local 
Engagement, Division of Drug and Health Plan Operations, Centers for 
Medicare & Medicaid Services, Department of Health and Human Services;
    Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, 
Health Resources and Services Administration, Department of Health and 
Human Services, as ex-officio, non-voting member; and
    Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health 
Resources and Services Administration, Department of Health and Human 
Services, as ex-officio, non-voting member.

    Dated: June 21, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-13461 Filed 6-23-21; 8:45 am]
BILLING CODE 4150-26-P