HRSA Releases COVID-19 Resources & FAQ for 340B Covered Entities
The Health Resources & Services Administration (HRSA) has developed a COVID-19 Resources page that will continue to be updated throughout the COVID-19 public health crisis. HRSA has determined the pandemic allows for flexibilities and case-by-case evaluation for eligibility and compliance. For situations where COVID-19 may affect a covered entity’s 340B Drug Pricing Program (340B Program) compliance, HRSA has issued COVID-19-related frequently asked questions. Key takeaways include:
Registration of New Sites
For covered entities facing a surge in patient volume causing expansion to a new site and/or a concern about a new site’s 340B eligibility, the covered entity should contact the 340B Prime Vendor Program. Each covered entity’s circumstances will be handled on a case-by-case basis.
Currently, there are no specific updates to registration processes or timelines. Covered entities should continue to follow 340B requirements for location eligibility and registration processes.
Covered entities must continue to keep auditable records during this time; however, HRSA has allowed for these flexibilities in relation to patient definition:
- Less documentation in an encounter will be tolerated; however, the patient must have been seen at the entity and the record should identify the patient and document medical evaluation and the treatment provided or prescribed.
- If the patient is without insurance or identification, the patient can self-identify and self-report condition and history in instances where providers don’t have access to documented medical histories.
- If volunteer health professionals are providing healthcare, the covered entity must document:
- Volunteer’s name, address and relationship to covered entity
- Covered entity’s responsibility for providing care
- Emergent nature of the care
HRSA has stated it won’t waive the group purchasing organization (GPO) prohibition. However, if the covered entity is unable to purchase an item at 340B or wholesale acquisition cost (WAC) due to drug shortages, only then may it purchase on GPO. Further, a GPO prohibition-covered entity should update its policies and procedures to reflect these situations and maintain auditable records.
Due to the large number of individuals in quarantine and isolation, covered entities may see a rise in telehealth encounters for nonurgent patients. Covered entities should consider the effects of telehealth on their 340B Program.
HRSA understands that telehealth is a means to reach patients during this pandemic. Covered entities should outline the use of telehealth within their policies and procedures and maintain auditable records. A prescription resulting from a telehealth encounter and filled at an eligible contract pharmacy may be eligible for 340B if the 340B patient definition and 340B Program requirements are met.
Covered entities can prepare for the potential increase in telehealth encounters by ensuring that all 340B software data vendor feeds are up to date and include telehealth encounters, where appropriate. Many 340B vendors use patient encounter data feeds to qualify contract pharmacy prescriptions. Covered entities can assess their patient encounter feeds for:
- Inclusion of telehealth encounters from all 340B-eligible locations
- Location filters within the 340B vendor software are set up appropriately and allow telehealth locations to qualify prescriptions, if the location is 340B-eligible
- 340B vendor settings that include assessment of diagnosis code for 340B qualification, so all appropriate diagnoses for the telehealth encounter are documented and included within the patient encounter data feed
Covered entities should monitor 340B prescriptions qualifying as a result of telehealth encounters for compliance with the 340B Program.
HRSA stresses that it will continue auditing 340B Programs virtually. Covered entities should remain prepared to respond to HRSA audit inquiries and data requests.
BKD understands that varied interpretations of these changes can affect your 340B Program. We encourage your team to consider drafting and enacting policies and procedures that define the situations outlined above for your unique covered entity. To connect on this or other 340B topics, reach out to your BKD Trusted Advisor™ or use the Contact Us form below.