340B Program Services

Our 340B attorneys have a deep knowledge of the 340B drug pricing program and regularly provide support on 340B matters to healthcare organizations, including 340B covered entities, pharmacies, and service providers. The 340B practice includes a former in-house counsel for 340B Health – an association of more than 1,400 hospitals and health systems participating in the 340B program – and industry veterans who have experience as both in-house general counsel and outside counsel for national pharmacies and pharmacy service providers.

Our full-service 340B support includes assistance from attorneys who are nationally recognized for their experience in 340B and pharmacy regulatory compliance. Our attorneys are frequent speakers on the 340B program for conferences and webinars, including the 340B Coalition Annual Conference and Winter Conference, and they are a go-to resource for 340B and pharmacy compliance assistance. Our 340B practice also includes a nationally recognized pharmacy team that serves as operational and transactional counsel to pharmacies. We are also well versed on 340B public policy matters and disputes among program stakeholders, including scrutiny of the 340B program by lawmakers in Washington and litigation related to drug manufacturers’ 340B policies. We advocate on behalf of 340B providers at the federal level before Congress and the administration and track federal legislative and administrative developments related to 340B, drug pricing, and safety net providers.

We counsel clients on a variety of 340B issues, including:

  • Covered entity and child site eligibility.
  • Contract pharmacy arrangements.
  • 340B litigation.
  • 340B claim identification and other billing requirements.
  • Medicare and Medicaid billing and reimbursement policies.
  • Third party administrator and pharmacy service agreements.
  • HRSA audits of covered entities.
  • Drug manufacturer inquiries.
  • Self-disclosures.
  • Corrective action plans.
  • Represented a leading provider of 340B Drug Pricing Program services in its acquisition by a prescription benefit management subsidiary of a leading pharmacy healthcare provider

    We served as lead healthcare regulatory counsel, as well as provided antitrust, employee benefits and tax support, for a leading...
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    Client Type: Private Company
Jeffrey I. Davis
Member
Michael R. Hess
Member
Dante G. Lizza
Associate
Christine M. Morse
Member
Shannon Wiley
Member

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