The annual recertification process for all hospitals participating in the 340B Drug Pricing Program begins on August 10, 2016.
Participating 340B hospitals have until September 7th to complete recertification. Failure to do so within the given time frame will result in immediate removal from the program. It is important to note the time frame is shorter than previous years. Hospitals will have four weeks to complete the recertification process.
It is also important to note changes to this year’s process by HRSA. Attestation language is changing in regards to self-disclosure. The term “materiality” has been removed and replaced with reporting any breach in 340B compliance. HRSA has confirmed that the expectation is for entities to have policies and procedures regarding breaches of compliance and materiality.
Resources are available to help guide hospitals through this process. User guides can be found on the OPA database at http://www.hrsa.gov/opa/. To recertify, hospitals will want to coordinate with their compliance, administration and finance teams, and also have their most recently filed Medicare Cost report on hand.
HRSA will send information directly to the Authorizing Official and Primary Contact on August 8th, 2016 (as it is listed for both the Parent and Child Sites). The email will come from email@example.com and will outline the initial information. It is imperative that your Authorizing Official’s e-mail address is up to date on the OPA database. Recertification is directly contingent upon the Authorizing Official’s receipt of the Username and Password from HRSA on August 10th to begin the process. If a covered entity needs to verify which email address will receive the login information, they can contact Apexus.
Questions regarding recertification should be directed to Apexus Answers via email at firstname.lastname@example.org or by phone (1-888-340-2787), though we welcome you to contact us if you have questions or concerns via email (email@example.com ) or phone (1-855-835-340B).