Immediate 340B Eligibility Possible for New Facilities as part of COVID-19 Response

The Health Resources and Services Administration (HRSA) recently announced that it will allow certain facilities not currently enrolled in the 340B Program to immediately enroll on a case-by-case basis, outside of the normal quarterly 340B enrollment periods, during the COVID-19 public health emergency.

This exception appears to apply primarily to new or relocated Child Sites of existing Covered Entities, but the rule also provides enough latitude for entirely new Covered Entities that meet eligibility requirements to enroll. This exception can provide significant drug cost savings and help offset increased costs/loss of revenue caused by the COVID-19 crisis.

Entities are instructed to reach out to Apexus via email or phone (1-888-340-2787) to make requests for immediate facility eligibility. Entities should be prepared to provide the following:

  • A narrative overview of the hospital’s current response to the COVID-19 public health emergency;
  • An explanation as to why immediate 340B enrollment is urgently needed to support that response; or
  • Demonstrate that the facility is able to otherwise meet 340B Program requirements.

HRSA will be posting an updated Medicaid Exclusion File (MEF) every Friday, listing entities that have been immediately approved and enrolled in the 340B Program. Several grantee health centers and hospital Child Sites have already been approved. Advis stands ready to answer any questions related to emergency 340B enrollments or to assist with drafting requests.

In conjunction with the easing of 340B enrollment protocols, various healthcare groups, and some legislators, continue to request further accommodations for 340B Covered Entities during the COVID-19 public health emergency. Requests include, among others, calls for further flexibility in meeting current program requirements and a pause on 340B DSH eligibility determinations through 2021 to account for unforeseen changes in patient/payer mix.

Advis will continue to track these developments and provide further guidance if these requested initiatives are adopted by HRSA or included in subsequent stimulus package legislation.

Please refer to the COVID-19 Information Repository for Advis’s previous 340B-related updates and recommendations for ensuring program compliance throughout the pandemic. Advis’s 340B experts are also available for any further inquiries:

Dan Avants, J.D.

Amanda Bogle, J.D.

Michael French, J.D.

Published: April 17, 2020