< Back to Thought Leadership

COVID-19 and the Impact on 340B

We wanted to provide an update from HRSA on the latest information regarding COVID-19 and the impact on the 340B Program.  The current public health emergency has created circumstances where a covered entity’s COVID-19 response may affect its 340B Program’s compliance and eligibility.  HRSA states that while they cannot waive statutory requirements of the 340B Program, they do feel that there is flexibility in the interpretation of the requirements.  Below are a few highlights from the update:

  • A covered entity in this public health emergency should continue to ensure it has policies and procedures in place to address the proper dispensing of 340B drugs and it must continue to keep auditable records.
  • An abbreviated health record may be adequate for purposes of the 340B Program. The record should identify the patient, record the medical evaluation (including any testing, diagnosis or clinical impressions) and the treatment provided or prescribed.
  • When utilizing volunteer health professionals to provide health care, emergency documentation should be generated to define the relationship between the provider and the covered entity and to clarify covered entity’s responsibility for providing care.
  • Hospitals subject to GPO prohibition may use a GPO to purchase medications due to shortages and if it is unable to purchase the medication at either 340B or WAC. Hospitals do not need to report this information to HRSA under the COVID-19 public health emergency.
  • HRSA will be moving towards conducting 340B audits virtually for the next several months.

The full update can be found at https://www.hrsa.gov/opa/COVID-19-resources.

We will continue to monitor the ever-changing impact of COVID-19 and work to provide additional updates. However, if you have any questions, please contact one of our 340B experts.

Please continue to monitor our Coronavirus Resources and Information Page and COVID-19 Relief & Operations FAQs for updates.

House Passes Bill to Provide Coronavirus Relief; Senate Expected to Act this Week

Coronavirus Relief Bill: Families First Coronavirus Response Act (FFCRA)

This article was originally published on March 17th and is being updated as new information becomes available. Please note this article is intended to address some of the most common questions we are receiving from clients and is not intended to cover the provisions of the Act fully. The U.S. Department of Labor has developed […]

Learn More

The CARES Act: Economic Injury Disaster Loan (EIDL) Program vs. Paycheck Protection Program (P3)

On Friday, March 27, the President signed and enacted into law the Federal stimulus bill in response to the COVID-19 virus, known as the CARES Act. Many key provisions in the Act benefit small businesses and nonprofit agencies, including the small business loan programs administered through the U.S. Small Business Administration (SBA), like the Economic […]

Learn More
COVID-19 Relief Impact: Employment Issues & Labor Law Considerations

Webinar: COVID-19 Relief Impact: Employment Issues & Labor Law Considerations

Thursday, April 2nd at 11:30 a.m. EST In this webinar, we will be partnering with Tami Earnhart from Ice Miller, LLP to discuss the employment issues related to the Families First Coronavirus Response Act (FFCRA) and other COVID-19 relief efforts. We will cover the following: General summary of the regulation and its impact including: Paid […]

Learn More