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Association Asks HRSA for Additional 340B Flexibility

In an April 30 letter, America’s Essential Hospitals thanked the Health Resources and Services Administration (HRSA) for issuing guidance on 340B Drug Pricing Program flexibility during the COVID-19 public health emergency, but outlined remaining hurdles essential hospitals face as the number of cases rises.

The association wrote that the guidance helped to clarify lingering questions that covered entities have as they prepare for and respond to the pandemic, but noted other program requirements HRSA can waive to better support essential hospitals during the crisis. The association offered these recommendations to HRSA on additional guidance to allow all covered entities to direct their limited resources to COVID-19 response efforts:

  • HRSA should allow newly eligible entities and sites to immediately register and begin purchasing 340B drugs for the pendency of the public health emergency declaration. HRSA should clarify that the policy regarding entities immediately enrolling in the 340B program “upon request and review” applies not just to newly eligible covered entities but also to child sites, and HRSA can further clarify it will waive the filed cost report requirement so that the child site can register immediately;
  • HRSA should relieve administrative burden during the COVID-19 pandemic by suspending program audits. Responding to detailed audit requests is a significant time and resource investment  that essential hospitals cannot afford as they respond to COVID-19. HRSA has said it will conduct audits virtually during the public health emergency, but the association urges HRSA to go one step further and suspend audits altogether until the emergency declaration expires; and
  • HRSA should disregard disproportionate share hospital (DSH) payment adjustment percentage changes during the COVID-19 emergency declaration. Hospitals are delaying and stopping non-emergency procedures during the public health emergency to focus on COVID-19, and therefore have faced significant financial losses. These operational changes likely will alter payer mix, changing a hospital’s DSH adjustment percentage. HRSA should disregard any changes in DSH adjustment that arise as a result of a hospital’s response to COVID-19.

We encourage all members to visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Abigail Painchaud is a policy associate at America's Essential Hospitals.

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