White Paper

4 Pages
  • 4 Pages

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities


Two announcements could have broader implications.

The Health Resources and Services Administration published two announcements in late 2018. The focal point of these announcements surrounds the agency’s plans to heighten oversight of drug manufacturers under the 340B drug pricing program, as well as clarity for the 340B ceiling prices for covered entities. This white paper outlines the HRSA's these announcements and their implications for covered entities.



Jeffrey I. Davis

Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Jeffrey I. Davis is Of Counsel/Senior Advisor in the Washington, D.C. office of Baker Donelson. Jeff Davis helps clients navigate the complex policy and legal issues surrounding the 340B drug pricing program, including Medicare and Medicaid-related compliance requirements, and provides clients with strategic policy advice and counsel on health care matters. Prior to joining the Firm, Mr. Davis served as vice president and legislative and policy counsel for 340B Health, a nonprofit organization of more than 1,300 hospitals and health systems participating in the 340B drug pricing program. During his more than seven years with 340B Health, he provided hospitals with technical assistance on 340B, Medicare, and Medicaid program compliance issues, oversaw research and policy efforts, and helped lead the government relations team in their work to educate members of Congress and their staff on the importance of the 340B program to hospitals and their patients. Mr. Davis is also a frequent speaker at major industry forums, making regular presentations at annual 340B Coalition conferences, state hospital association meetings, drug manufacturer conferences, and other professional association events.

Mr. Davis previously served as the health care legislative assistant for U.S. Representative Shelley Berkley (D-NV), where he advised Rep. Berkley on health care issues and legislation before Congress and the House Ways and Means Committee and partnered with health care providers to promote increased Medicare funding for hospitals, physicians, nursing homes, acute care and long term care facilities, and other providers.

Tracy E. Weir

Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Tracy E. Weir is a shareholder in the Firm's Washington, D.C., office where she represents clients in a broad range of matters, including Medicare reimbursement and compliance, antitrust, administrative appeals before the Office of Hearings and Appeals, HIPAA/HITECH and the 340B Drug Pricing Program.

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