Appointment of Administrative Dispute Resolution Board Members
Primary source
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Issuing agencies
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Page 33317]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
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