Foley has scheduled a call on Thursday, September 24, 2015 at 8am PST/10am CST/11am EST to convene 340B Program covered entities that may be interested in forming a “coalition” to develop a response to HHS/HRSA’s recently proposed comprehensive 340B Program guidance, beginning with (but not necessarily limited to) the preparation of comments on the guidance. Interested covered entities are invited to attend this free “kickoff” call.

HHS/HRSA’s proposed guidance, if finalized, would have a significant financial and operational impact on participating 340B covered entities.

Some of the key issues raised in the proposed guidance include:

  • The ability to purchase 340B drugs for hospital-based infusion centers where the physician ordering or prescribing the infusion is not employed by/under contract with the hospital
  • New requirement for 340B covered entities to bill for the professional services for individuals receiving 340B drugs
  • New requirement that only patients whose services are billed to payors as outpatient services are eligible for 340B drugs
  • The ability to use 340B drugs when the drugs are reimbursed by Medicaid programs through certain types of bundled payments
  • The ability to use 340B drugs for Medicaid managed care patients, including through contract pharmacies

If you are a 340B covered entity interested in participating in this call, please contact Elizabeth Elson at or the Foley attorney you work with to obtain call-in information.