Hospital Authorizing Officials should have received an email from 340b.recertification@hrsa.gov with their username and password for recertification. Hospitals have 28 days to recertify for the 340B Program or they risk being removed from the 340B Program.
Things to remember:
All hospitals must recertify between August 10, 2016 and September 7, 2016.
The Authorizing Official (AO) is the only one that receives the username and password for recertification.
Last year’s username and password will not work.
If the AO did not receive the email or has misplaced email, you can call 1-888-340-2787 and have it resent.
There is a recertification user guide available at http://opanet.hrsa.gov/OPA/UserGuides.aspx.
Hospitals that are new to the 340B Program with a start date of July 1, 2016 must recertify.
Hospitals that have been approved for the 340B Program with a start date of October 1, 2016 do not need to recertify.
The OPA warned that the DSH percentage will not auto-populate. The hospital must enter the DSH percentage and cost reporting period from their most recently filed Medicare Cost Report worksheet E part A. The date is at the top of the worksheet and the DSH percentage is on line 33.
The attestation language has changed slightly but the AO is still certifying on behalf of the covered entity (CE) that:
All of the CE’s information listed in the OPA database is complete, accurate and correct;
The CE meets all 340B Program requirements;
The CE will comply with all of the 340B Program requirements including, but not limited to, prohibition against duplicate discounts and diversion;
The CE maintains auditable records;
Any contract pharmacy arrangements are performed in accordance with OPA requirements and guidelines;
The CE acknowledges its responsibility to contact OPA as soon as possible if there is any change in their 340B eligibility and/or breach;
The CE acknowledges that if there is a breach of any of the 340B requirements, they may be liable to the manufacturer and may be subject to removal from the 340B Program.
If the hospital chooses to decertify, be prepared to give:
The date the reason for termination was effective;
A brief description of the facts surrounding the reason for termination and how the effective date was determined; and
The last day that 340B drugs were purchased.
You must click on “Certify” and “Done” to send.
The Authorizing Official will receive a completion email notification if everything sent correctly.
The hospital will not be able to view changes in the general database until OPA has signed off on the hospital’s recertification.
Do not wait until the last day! Hospitals that wait until the last day to recertify may experience delays in technical assistance due to the user volume.
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!
