At the 340B Coalition, Captain Krista Pedley, Director of Office of Pharmacy Affairs, confirmed that hospital recertification will be in August. The recertification process is done on a rolling basis for each entity type. All covered entities are required to recertify for the 340B Drug Pricing Program each year. If the 340B covered entity fails to recertify, they will be removed from the 340B Program. The covered entity’s Authorizing Official should be on the look-out for their email with recertification details.
The entity’s eligibility criteria should automatically populate from the Medicare Cost Report data and the Authorizing Official must attest that the covered entity meets ALL 340B Program eligibility requirements. Below are the 8 statements that the Authorizing Official will need to attest to:
- Accuracy of 340B database information
- Covered entity meets ALL eligibility requirements
- Covered entity will comply will ALL requirements/restrictions
- Auditable records are maintained
- Mechanisms to ensure ongoing compliance are in place
- Contract pharmacy compliance in accordance with OPA guidance and requirements
- Responsibility for self-disclosure of material changes or breach
- Potential liability to the manufacturer or removal from 340B program if material breach occurs
If an entity decides to decertify during the recertification process, the covered entity will need to address the following questions:
Termination effective date
Brief description for reason of termination and how effective date was determined
Last 340B purchase date with the impending decertified 340B ID
Pedley stated that should a compliance concern arise through recertification or decertification, HRSA staff will follow-up and investigate the concerns with the entity. HRSA believes the accuracy and integrity of the database has been significantly improved by undergoing the annual recertification process. Since 2012, there has been a 50% decrease in the percentage of entities failing to recertify and in total decertification.
For more information about recertification, please refer to this post HERE. And, if you are curious what 340B recertification best practices look like and would like some helpful hints, read the post HERE.
Southwest Consulting Associates’ 340B Audit and Compliance team can assist you with the recertification process if needed. Please contact us at 972-732-8100 or email us at 340B@southwestconsulting.net.
We’ve got more to write on the recertification process and 340B compliance in general including 340B external audits, 340B compliance reviews, 340B program requirements, 340B audit results, etc. Don’t miss out on future articles delving deeper into the 340B program!
