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5 Key Compliance Measures for your 340B Program During COVID-19

The environment surrounding COVID-19 is revealing an unprecedented and evolving situation for covered entities to maintain their 340B compliance. On Friday, April 3rd, Hudson Headwaters 340B hosted a webinar titled, “Compliance in the Time of COVID-19” to keep Third Party Administrative Clients up to date on how to account for these changes in their programs. The webinar was hosted by Jim Donnelly, President, and Katelyn Keys, Compliance Manager, and moderated by Stephanie Willis, Marketing Specialist. Our team continues to learn from trusted officials, HRSA, 340B Health, and Apexus as we navigate client programs and put together a list of resources and helpful measures to consider during and after the pandemic.

Prepare to be flexible. All current language presented with consideration to 340B Compliance during COVID-19 emphasizes the need for flexibility as covered entities adapt to new best practices. The HRSA FAQ Page related to the pandemic will often use language that indicates HRSA “should recognize the emergency nature of the situation.” As the circumstances change, so will the necessary steps that all entities need to consider.

Update Policy and Procedures. Your 340B Policy and Procedure Manual is documentation where entities should detail the specific practices of their 340B program. As COVID-19 started impacted the American health system safety-net, there have been suggested language additions to add that allow flexibility.  Three things to make sure you address in the new Public Health Emergency section of your Policy and Procedures include:

  • Telemedicine technology as it related to 340B patient definition. Include how your covered entity and Third-Party Administrator will be using and qualifying eligible prescriptions from these visits. Maintain that the responsibility for the care provided remains with the entity.
  • Note that emergency refills or refill extensions can be deemed eligible based on the original 340B eligible prescription. Maintain the specific parameters you would look for while internal auditing these refill situations
  • Consider the way credentialing and new “pop-up” sites with potential volunteer staff will be noted in your EMR system and how that information will be sent to your TPA. More on credentialing below.

Maintain Database Accuracy. HRSA has extended flexibility for registering sites and determining eligibility during COVID-19. If there are specific questions about your program, they encourage you to reach out to Apexus

Review All Reporting. During the COVID-19 outbreak, health centers and hospitals are seeing a decrease in physical patient encounters due to the shift in telehealth. Some entities may still be in the process of growing their telehealth capabilities and will see a dip in e-prescribing for a period of time. It is essential to monitor financial statements and trending with your TPA to confirm that any change in 340B benefit has a traceable reason. Some entities are also seeing an increase in maintenance drug prescriptions being filled for 90 or 120 days instead of 30, which will also impact the standard month to month trending for your program. Clients of Hudson Headwaters 340B are encouraged to review their Client Portal for various trending graphs and reach out to their dedicated client representative with any questions or to dig into any discrepancies.

Use Your Resources. We are all in this together, and now it is more important than ever to make sure we share helpful information. Make sure you are in regular communication with the contacts and businesses that are important to your program management to confirm any special actions they are taking during the outbreak. Hudson Headwaters 340B is proud to provide no delay in service as we continue to utilize a work from home environment while maintaining entity programs. Below is a list of resources that we have found to be helpful during the outbreak:

  • AHI Telehealth – Adirondack Health Institute is an independent non-profit organization local to Glens Falls, NY. Their website provides a variety of resources and recorded webinars that are helpful when considering Telehealth visits.
  • 340B Resources and FAQs – Resources maintained by HRSA are posted regularly on their website, as well as a series of Frequently Asked Questions that are beneficial to program participants.
  • 340B Exchange Forum – This is a discussion board maintained by 340B Health where hospital and health center contacts can ask and answer questions based on their experience in 340B.
  • Noddlepod – This is a resource developed by NACHC for Community Health Center Clients to be able to engage in discussion on a variety of compliance, clinical, and 340B specific topics.

As always, Hudson Headwaters 340B strives to maintain at the forefront of your program compliance. Clients with questions are encouraged to reach out to their dedicated representative or key contact. Are you new to 340B or looking for a partner in the program who will put your compliance first? Please use our Contact Us form with your specific questions, and we will be happy to start the conversation.