In our last post, we covered the ins and outs of 340B recertifcation. Here is a quick rundown of the recertification process and since the process can seem overwhelming, we thought we'd equip you with some helpful tips/best practices to make the process smoother for covered entities.
340B Recertification Basics
-
Authorizing officials and primary contacts will receive notification emails TODAY, August 3rd
-
Recertifcation window begins August 5th and end September 9th
-
All covered entities registered for the 340B drug pricing program as of July 1, 2015 without a future term date must recertify
-
FAILURE TO RECERTIFY = REMOVAL FROM PROGRAM
-
OPA database information must be verified
-
Authorizing official must attest to 340B compliance
Please refer to our previous post for more detailed information on what is all involved in verifying OPA database information and the required compliance attestations.
Helpful Hints/Advance Prep
Here are some helpful tips to make the recertification process smoother for covered entities:
-
START NOW
-
Before recertification begins, verify your authorizing official and primary contact information
- Contact Apexus Answers Hotline to verify correct email addresses are listed
-
Notify authorizing official that recertification is looming and be on the lookout for emails
-
Review your spam filters
-
Save screen shots as you move through the OPA database for your records
-
Review as much information in advance that you can. No need to wait for August 5th to begin reviewing database information
-
Download OPA’s recertification user guide
-
Review OPA’s outpatient facility registration policy
-
Assign responsibility for verifying database information to hospital officials
-
Familiarize yourself with the Medicare cost report (Worksheets E part A, S-2, S-3, A and C) and have on hand as you move through the OPA database
-
Know your Employer Identification Number
-
Have your 340B policies and procedures on hand as well as any contract pharmacy agreements
-
Pre-review the 8 compliance attestations and determine if self-disclosure is necessary prior to completing recertification
-
If any changes are made to Medicaid billing/orphan drug information during recertification, the covered entity SHOULD NOT make any operational changes until October 1st, as that is the effective date
-
If compliance is in question, consult your legal counsel
While 5 weeks seems like ample time to complete this recertification process, we suggest starting the process as soon as possible to account for covered entities with multiple child sites, uncontrollable factors such as hospital officials on vacation or heavy website traffic slowing the submission process on the OPA website. T-minus 2 days until the recertifcation window opens!
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!
