White Paper

5 Pages
  • 5 Pages

HRSA Guidance Updates Suggest Tightening of 340B Covered Entity Repayment Rules


Review the latest HRSA expectations.

The HRSA's updated 340B program guidance from 2018 expressed a heightened attention to 340B covered entity compliance expectations; notably in regards to audits, CAPs, and repayments to manufacturers. There has also been talk of a readiness to make changes that could result in limited access to 340B savings by certain entities. This white paper reviews the HRSA updates and discusses what covered entities need to consider in order to stay consistent with HRSA expectations.



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.

Christine M. Morse

Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Christine M. Morse is a shareholder in the Baltimore office of Baker Donelson. Christine Morse focuses her practice on issues related to fraud and abuse claims, reimbursement, corporate compliance, long term care and Medicare Part B. Ms. Morse's strong regulatory background provides the necessary foundation for her health care practice, which typically includes coordination of, and participation in, acquisition due diligence, compliance effectiveness reviews, internal investigations, voluntary disclosures, investigations resulting from inquiries by various governmental authorities, and negotiating Corporate Integrity Agreements (CIAs). She has represented a wide range of provider types, including hospitals, hospital systems, pharmacies, laboratories, durable medical equipment (DME) providers, home health providers, physicians and other health care practitioners, device manufacturers, nursing homes and other long term care providers. She regularly addresses clients' concerns and issues arising from state and federal self-referral laws (including Stark), Anti-kickback laws and false claims laws. She has worked on numerous qui tam (whistleblower) suits.

Ms. Morse's work often overlaps with our White Collar Group. More recently, she has assisted in government investigations initiated by United States Attorneys Offices and state Attorneys General Offices of various provider types, including laboratories, pharmacies and hospitals. Ms. Morse has represented providers from the initial phases of an investigation through settlement and/or litigation and has experience in subpoena response, document productions, witness interviews and negotiation processes. With more than ten years' experience in compliance issues relating to many different provider types, and familiarity with providers' operations, she has demonstrated the ability to bring professionalism and positive results in those situations where complex and sensitive issues often arise.

Ms. Morse has also developed significant legal and operational experience relating to institutional and specialty pharmacies, including licensure, Medicaid reimbursement and Medicare Part D issues. Additionally, Ms. Morse has experience in assisting both pharmacies and "covered entities" such as Disproportionate Share Hospitals (DSHs), Federally Qualified Health Centers (FQHCs), and Ryan White Centers with issues related to their participation in the Health Resources and Services Administration's (HRSAs) 340B Drug Discount Program.

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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