Legal Update, May 2020

Legal Update

340B Program Flexibilities During COVID-19 Pandemic
By Elizabeth 'Issie' Karan

Hemophilia Treatment Centers (HTCs) may benefit from relaxation of 340B Drug Pricing Program policies during the COVID-19 pandemic. The Office of Pharmacy Affairs (OPA) which oversees the 340B Program developed a website with resources and frequently asked questions (OPA FAQs) related to the COVID-19 pandemic. Below we highlight two important developments. Additionally, the Hemophilia Alliance also has been working with OPA to ensure that hemophilia treatment centers (HTCs) can register contract pharmacies outside of the registration period to ensure adequate supplies of products.

The OPA FAQs identify important flexibilities for covered entities. First, regarding telemedicine, OPA acknowledges that this is simply a mode of delivery which does not alter 340B patient eligibility. However, OPA recommends that covered entities address these modalities in their policies and procedures and continue to ensure auditable records are maintained for each eligible patient dispensed a 340B drug. We recommend adding language to your 340B policies and procedures, which explicitly incorporates telemedicine into your patient definition, and ensuring that providers continue best practices in recordkeeping. Second, the OPA FAQs also announce that 340B audits will continue to be conducted during the pandemic but will be done virtually for the next several months. Although OPA is not cancelling audits, covered entities may be able to request delays in commencing audits if COVID-19 is impacting resources or operations.

If your HTC is having any difficulties with 340B Program compliance or operations, please reach out to us to ensure you are maximizing your options during this unprecedented time.

Also in this Issue…

Notes from Joe

Washington Update
· CMS Releases a Second Rule to Provide Flexibility During COVID Emergency
· CMS Releases Rule Reopening Door for Accumulator Adjustor Programs

Payer Update
· HANS Announces New Payer Agreement

Alliance Update
· 2020 Meeting Schedule

Notes from the Community
· All About the WAAPS-Hemo System