August 7th, 2014
All hospitals with an active 340B ID as of July 1 are required to recertify to maintain their 340B eligibility. Failure to recertify annually will result in removal from the program.
July 28th, 2014
Last week, the Health Resources and Services Administration (HRSA) issued an interpretive rule clarifying their position that manufacturers should continue to extend 340B prices for orphan drugs when these drugs are purchased and used by free-standing cancer hospitals (CAN), sole community providers (SCH), rural referral centers (RRC) and critical access hospitals (CAH) for non-orphan indications.
July 18th, 2014
The first communication regarding HRSA’s third annual mandatory recertification process for participating 340B hospitals will be sent to the authorizing official for each hospital around Aug. 1.
July 11th, 2014
As the Health Resources and Services Administration (HRSA) continues to enhance their role in 340B Program oversight, they have made three changes that will affect covered entities. While the overall process remains mostly unchanged, recently-announced enhancements to post-audit procedures will impact how covered entities learn about and respond to audit findings.
July 10th, 2014
All new covered entities, outpatient facilities, and contract pharmacies can register now through July 15 for an effective start date of Oct. 1. The OPA encourages organizations to register early to allow time to resubmit if they determine that the information provided is incorrect or incomplete.