COVID-19 Resources

HRSA is working to keep 340B Program participants and stakeholders updated on the latest information regarding the coronavirus disease 2019 (COVID-19). All COVID-19 information related to the 340B Program will appear on this page, and we will update resources as they become available.

CDC Resources

340B Resources

HRSA understands that many 340B stakeholders are concerned about the evolving impact of the COVID-19 pandemic.  The circumstances surrounding this public health emergency may warrant additional flexibilities, especially to affected 340B covered entities. To the extent a 340B stakeholder has a specific circumstance where they believe their COVID-19 response may affect their compliance or eligibility in the 340B Program, the stakeholder should contact the 340B Prime Vendor at 1-888-340-2787 (Monday – Friday, 9 a.m. – 6 p.m. ET) or apexusanswers@340bpvp.com HRSA Exit Disclaimer. The 340B Prime Vendor will coordinate with HRSA technical assistance and evaluate each issue on a case-by-case basis. Below are general flexibilities that covered entities should adhere to during this public health emergency.

Section 340B(a)(5)(B) of the Public Health Service Act prohibits covered entities from reselling or otherwise transferring a 340B covered outpatient drug to a person who is not a patient of the entity. In determining whether an individual qualifies to receive 340B drugs, HRSA believes that it is appropriate to take into account the realities of the COVID-19 pandemic. 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. During this time, 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. For purposes of 340B Program eligibility, the record may be a single form or note page. It is the recorded information that creates a record. For example, under these circumstances the patient may be without insurance cards or identity papers and providers may not have access to documented medical histories. In the current public health emergency, HRSA believes that self-reporting of identity, condition, and history are adequate for purposes of 340B recordkeeping requirements.

In addition, in a situation where volunteer health professionals are providing health care, emergency documentation should be generated to make the relationship between the provider and the covered entity clear and to make clear the covered entity’s responsibility for providing care. This documentation should recognize the emergency nature of the situation, the name and address of the volunteer, and his/her relationship to the clinic, and should be kept on file by the covered entity.

FAQs

Below are some general frequently asked questions (FAQs) related to COVID-19.  If you have a question related to COVID-19 that is not covered by the information on this page or in the FAQs below, please contact the 340B Prime Vendor Program at 1-888-340-2787 or apexusanswers@340bpvp.com HRSA Exit Disclaimer.

We are seeing a surge in patients and need to expand our services to another site. Will any special exemptions be made for covered entities or any changes to the registration process?

To the extent a covered entity has a specific concern about 340B eligibility of a new site, the covered entity should contact the 340B Prime Vendor Program (1-888-340-2787 or apexusanswers@340bpvp.com HRSA Exit Disclaimer) and we will evaluate each circumstance on a case-by-case basis. In addition, please review the content on this webpage for certain flexibilities during this time.

Will HRSA relax its standards around the definition of a patient for purposes of providing covered outpatient drugs to all who need treatment related to COVID-19?

At this time, HRSA is unable to waive 340B statutory requirements, specifically the provision related to reselling or otherwise transfer the drug to a person who is not a patient of the entity, pursuant to section 340B(a)(5)(B) of the Public Health Service Act. However, please review the content on this webpage for certain flexibilities during this time related to recordkeeping.

*REVISED* With the current situation of the COVID-19 crisis, will HRSA reconsider allowing hospitals subject to the Group Purchasing Organization (GPO) prohibition to purchase 340B covered outpatient drugs through a GPO?  Will HRSA still require reporting upon use of a GPO? (Updated 3/23/2020)

HRSA is unable to waive the 340B statutory requirements, specifically with respect to the Group Purchasing Organization (GPO) prohibition pursuant to section 340B(a)(4)(L)(iii) of the Public Health Service Act.  Hospitals that are subject to the GPO prohibition include disproportionate share hospitals, children's hospitals, and freestanding cancer hospitals.

These hospitals may not use a GPO for covered outpatient drugs at any time, including private label products. However, if a hospital is unable to purchase a covered outpatient drug at the 340B ceiling price, the covered entity should first try to obtain the drug at wholesale acquisition cost (WAC). If it is also unable to purchase the product at WAC due to shortages, a hospital may use a GPO (or GPO private label products).  Hospitals do not need to report this information to HRSA under the COVID-19 public health emergency.  The covered entity should address these situations in their policies and procedures and it must continue to keep auditable records.

Will HRSA allow manufacturers the ability to offer their private label drugs at the 340B ceiling price to all covered entities, including those who are subject to the GPO prohibition?

To the extent a manufacturer with a 340B Program Pharmaceutical Pricing Agreement (PPA) has private label products that are covered outpatient drugs and the manufacturer has plans to make those private label products available to all covered entities at or below the 340B ceiling price, manufacturers are encouraged to contact HRSA directly at 340Bpricing@hrsa.gov so HRSA can work to ensure compliance of both the manufacturer and covered entities subject to the GPO prohibition.

Given the coronavirus 2019 pandemic, what flexibilities are available to entities to allow a provider to offer telehealth services?

HRSA understands that the use of technology in health care delivery during this time is critical, and that telemedicine is merely a mode by which the health care service is delivered. For the 340B Program, HRSA recommends that covered entities outline the use of these modalities in their policies and procedures and continue to ensure auditable records are maintained for each eligible patient dispensed a 340B drug.

Does HRSA plan to suspend or cancel audits based on COVID-19?

Based on the current COVID-19 pandemic, HRSA is moving towards conducting 340B Program covered entity audits remotely (virtually) for the next several months while we monitor and assess the impact on the covered entities.  If a covered entity has specific questions regarding an audit once it has been engaged, please contact the Bizzell Group (the 340B audit contractor) at 340baudit@thebizzellgroup.com HRSA Exit Disclaimer who will coordinate with HRSA based on the specifics of the request.  HRSA will continue to monitor the COVID-19 response and provide updates accordingly.

Date Last Reviewed:  March 2020