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340B Program Participants Take Note: New Technical Changes Are Coming

On September 5, 2017, the Health Resources and Services Administration announced the transition to a new Office of Pharmacy Affairs Information System (340B OPAIS), which will impact and modernize the current 340B covered entity database and will also impact the mechanism through which drug manufacturers report 340B drug prices to HRSA. To educate both covered entities and drug manufacturers about the details of the new 340B OPAIS, the Office of Pharmacy Affairs will be conducting two public webinars later this month.

Since the announcement has not been published on HRSA’s website as of the time of this post, the full text of the announcement has been reprinted below. We encourage all 340B program stakeholders to take advantage of this educational opportunity.

HRSA

Dear 340B Stakeholders,

The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is transitioning to a new Office of Pharmacy Affairs Information System (340B OPAIS). 

The 340B OPAIS will have two separate components – a new registration system and a new secure pricing system. The registration component of the new 340B OPAIS will be released in mid-September and the pricing system will be released at a later date. The registration component of the new 340B OPAIS will modernize the current 340B Database to enhance its functionality and security for both manufacturers and covered entities. This new system will increase the integrity and effective use of 340B stakeholder information.

OPA will hold two webinars on September 13, 2017. The first webinar is from 1:00-2:00 PM EST to prepare covered entities for the new registration component of the system. The second webinar will be held from 2:00-3:00 PM EST for manufacturers to update them on the new registration component of the system.  While all stakeholders can attend the webinars, there is a limited amount of space. Therefore, we encourage that you only attend the session that is pertinent to you. Both webinars will be recorded and can be viewed on the OPA website after September 13, 2017. 

HRSA OPA 340B Covered Entity Update
When:  September 13th, 2017 1:00 PM - 2:00 PM EST
Conference Number(s):  800-857-9665
Participant Code: 4780274
To join the meeting:
https://hrsaseminar.adobeconnect.com/hrsa_opa_340b/
 
HRSA OPA 340B Manufacturer Update
When:  September 13th, 2017 2:00 PM - 3:00 PM EST
Conference Number(s):  800-857-9665
Participant Code: 4780274
To join the meeting:
https://hrsaseminar.adobeconnect.com/hrsa_opa_340b/

Questions regarding registration, change requests, or recertification can be directed to the 340B Prime Vendor Program at (888) 340-2787 or ApexusAnswers@340bpvp.com.
 
Arent Fox’s Health Care group regularly monitors and counsels clients with respect to compliance with the 340B Drug Pricing Program. If you have any questions or need assistance, please contact Stephanie Trunk or Erin Atkins in our Washington, DC office, or the Arent Fox professional who regularly handles your matters.