August 27, 2015
The Health Resources and Services Administration (“HRSA”) released an advanced copy of its long-awaited proposed 340B Omnibus Guidance (“Guidance”) today. The document can be found here. Polsinelli is currently reviewing the proposed Guidance, and we will issue a follow-up communication containing our summary of the document, as well as our thoughts and impressions on how the proposal may impact stakeholders.


Based on our preliminary review, HRSA is proposing substantial changes that would have a significant impact on 340B participants (“Covered Entities”). The Guidance will likely impact all Covered Entities in some way, but we believe smaller and rural providers - as well as those Covered Entities that do not employ or contract with physicians - will be most affected if the guidance is finalized.

HRSA proposed a number of significant changes to the patient definition (pages 23-31; 72-74). Below is a brief overview of HRSA’s proposed changes to the patient definition:
  • Reduction/elimination of discharge prescription programs as the Guidance requires 340B prescriptions to originate from an outpatient visit;
  • Requirement that Covered Entities bill or be able to bill for practitioners who prescribe 340B-priced drugs (e.g. employed or under a personal services arrangement with the Covered Entity). Medical staff privileges alone would be insufficient;
  • Infusion/chemotherapy must be ordered by a Covered Entity provider during a visit to Covered Entity. Outside referrals to Covered Entities for infusion/chemotherapy may no longer qualify for 340B and Pharmacist’s care may not be enough to qualify for the use of 340B drugs;
  • Prescription-by-prescription analysis by HRSA, which may impact Covered Entity’s ability to fill refills using 340B-priced drugs;
  • Telemedicine can result in the prescribing of 340B drugs if consistent with State and Federal law; and
  • The Guidance suggests that HRSA is proposing a notice and hearing process for covered entities to challenge adverse findings, such as findings of diversion to non-eligible patients, but the only reference to a hearing process pertains to manufacturers. The Guidance goes into detail about the “Notice” to Covered Entities, but does not describe a “Hearing “ process for Covered Entities that differs from what already occurs today.

Additional Information

Polsinelli will also be holding a complimentary webinar on October 6, 2015 that will include an in-depth analysis of the Guidance and will provide an opportunity for participants to ask questions. Details on the 340B webinar will follow.